Annual Report • Apr 20, 2021
Annual Report
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| Report of the Board of Directors | 5 7 |
|---|---|
| Statement of responsibility | 105 |
| Statutory's auditor Report | 106 |
| Consolidated Financial Statements | 111 |
| Notes to the consolidated financial statements 116 |

| Letter to shareholders | ||
|---|---|---|
| 2020 Highlights | 10 | |
| 2021 Outlook | 14 | |
| Mithra, inspired by Women | 16 | |
| Our staff | 18 | |
| Environmental commitment | 20 | |
| Research & Development | 24 | |
| Estetrol Platform | 26 | |
| Estelle ® |
28 | |
| Donesta ® |
30 | |
| Expansion of the Estetrol platform | 32 | |
| Complex therapeutics | ||
| Myring ® |
34 | |
| Tibelia ® |
36 | |
| Zoreline ® |
37 | |
| Mithra CDMO | 38 | |
| Key figures | 40 | |
| Mithra shar e |
42 | |
| Shareholding structure | 43 | |
| Mithra and its financial community | 44 | |
| 2021 Financial Highlights | 45 | |
| Governance | 46 | |



7

2020 was a year of significant progress for Mithra as we delivered on our operational commitments and strengthened our financial structure despite the challenging Covid-19 pandemic. We are proud of the resilience shown by Mithra and its teams during this extraordinary year.
We could not have chosen a more symbolic date than March 8, 2021, International Women's Rights Day, to obtain our first marketing authorization for the Estelle ® contraceptive pill based on our main asset Estetrol. Two weeks later, it was the turn of the European Medicines Agency (EMA) to give a positive opinion. Finally, on April 15, we received approval for the US market. A real achievement for a biotech, after many years of work. We have also expanded our global coverage with new commercial agreements with Gedeon Richter for Latin America, the third largest market worldwide, as well as with new partners for Australia, Hong Kong, Taiwan and North Africa.
Regarding our new generation hormone treatment Donesta ®, we have redoubled our efforts to ensure the smooth continuation of the Phase III clinical program under the known health conditions. Patient recruitment should be finalized during the first half of this year.
If it shook us all in our daily life, the world pandemic also particularly nourished the scientific researches and the pharmaceutical developments. In the wake of several international studies having demonstrated the protective effect of estrogens against this type of virus, Mithra has launched a phase II study to examine the effect of Estetrol on the immune, inflammatory and vascular response of patients infected by Covid-19. The first results of this "Coronesta" study are expected early in the second half of 2021. This new direction demonstrates the potential of Estetrol in indications beyond women's health alone.
Our teams have also worked to strengthen the intellectual property portfolio related to Estetrol with the granting of a new patent extending the exclusivity of the product candidates Estelle ® and Donesta ® until 2036 in Europe. At the end of November, the EMA designated Estetrol as a new active substance, 80 years after the last such designation in contraception, once again testifying to the innovative nature of the research carried out on this estrogen.
In 2020, Mithra launched its contraceptive vaginal ring Myring ® in several European countries: in Germany, the largest European market and the second largest in the world, in Italy, fourth largest market in the world, as well as in

Austria, Belgium, Denmark and the Netherlands. Today, our ring is already marketed in seven countries, representing a total market of more than 60 million euros and nearly 7 million rings per year.
Myring®'s competitive advantage was reinforced with the approval by European authorities of the extension of Myring's shelf life from 24 to 36 months, providing distributors, pharmacists and patients with a more convenient option than competing products. In 2020, we signed seven new licensing and supply agreements covering key new territories.
The financial results of Mithra reached in 2020 were in accordance with our
expectations in this year of transition preceding the commercial launch of our pill Estelle® and taking into account the strategy of commercial development related to our product candidate Donesta®. Our solid financial position allows us to wait for the continuation of the development of clinical studies and to further enhance the value of this product in view of a unique commercialization contract with a global player.
Despite the volatility on the financial markets, Mithra successfully concluded various important financing operations, in particular a capital increase of 65 million euros and the issue of a convertible bond in the amount of 125 million euros, testifying once again to the confidence granted by the investors to our company. These financing operations enabled us to achieve a record cash position of nearly 139 million euros at the end of the year.
The renewal of our board of directors last November gave a dynamic momentum to the development of Mithra, which is about to live a turning point in its history. Thanks to the support of this new governance, we are determined to bring Mithra closer to its numerous promises.
This year 2021 should be marked by the granting of the marketing approvals of our main asset Estelle® in Europe and in the United States, followed by the commercial launch. These approvals are the result of many years of hard work of our R&D teams, our partners, and of the two founders of Mithra, François Fornieri and Jean-Michel Foidart.
We also intend to advance in our Phase III study Donesta® and to generate the first results within the framework of the program "Coronesta". Our Mithra CDMO should also run at full speed with the orders of Myring® for the European market and thanks to the launch of its new injectable production line.
We are convinced that the collaboration and the support of our teams and our various partners will enable us to carry out our strategic and operational promises during this year 2021. Mithra is close to reach its first big dream: offering to women all over the world a contraceptive pill of a new kind. And as a biotech, it has many other projects to develop to reveal all the potential of Estetrol.
Thank you for your continued support and confidence.
Patricia van Dijck President of the Board of Directors
Leon Van Rompay Chief Executive Officer


Directors last November has given a dynamic momentum to the development of Mithra, which is about to live a pivotal year in its history. With the support of this new governance, we are determined to bring Mithra closer to its many promises.
Patricia Van Dijck, President of the Board of Directors
Commercial launch of Myring® in Germany, the leading European market and the second largest market worldwide
Regulatory submission of Estelle® to the American FDA
€ 50 million capital commitment agreement signed with international investment group LDA Capital
Agreement with Gynial for the commercialization of Myring® in Switzerland
Regulatory submission of Estelle® to Health Canada
Launch of the Coronesta Research Program to study the action of Estetrol in the treatment of Covid-19
Agreement with Mayne Pharma for the commercialization of Estelle® in Australia
Commercialization agreement with Alvogen to market Estelle® in Hong Kong and Taiwan
Agreement with Farmitalia for the commercialization of Myring® and Tibelia® in Italy, the fourth largest vaginal ring market in the world
Significantly more environmentally friendly profile of Estetrol compared to other estrogens, demonstrated in an ecotoxicity study
Commercial launch of Myring® in Belgium, a market valued at € 5.1 million
The European Medicines Agency (EMA) validates the Marketing Authorization Application of Estelle® submitted by Mithra and Gedeon Richter
Deployment of a global Safety Management plan to continue the Donesta® Phase III clinical program with the emergence of the Covid-19 health crisis



Agreement with Spirig Healthcare for the commercialization of Tibelia® in Switzerland and Liechtenstein
€ 65 million raised through a private placement
FDA accepts Estelle® for registration in the United States

12

Presentation of Estelle® clinical results at the 19th Congress of the International Society of Gynecological Encrinology (ISGE)
€ 125 million convertible bond offering
Positive opinion of the independent expert committee on the safety of the Donesta® clinical program
Agreement with Gedeon Richter for the commercialization of Estelle® in Latin America, the third largest market in the world
Agreement with GyneBio for the commercialization of Estelle® in South Africa
Renewal of the Board of Directors with Mrs. Patricia Van Dijck as interim president
Agreement with Chemical Dampe for the commercialization of Myring® in Venezuela
Submission of the Estelle® registration file to the Brazilian regulatory authorities
Qualification of Estetrol as a "New Active Substance" by the EMA
Further strengthening of Estetrol intellectual property portfolio thanks to a new patent extending the 35 patent families of Mithra
Agreement with Zentiva for the commercialization of Myring® in France, Poland and the United Kingdom
Agreement with Megalabs for the commercialization of Myring® in Mexico
Commercial launch of Tibelia® in Canada as the first tibolone-based hormone treatment
Myring® shelf life extended to 36 months, a true competitive advantage in this market
Commercial launch of Myring® in the Netherlands
Publication of an article on the impact of Estelle® on haemostatic parameters in the prestigious scientific



After receiving its first approval in Canada at the beginning of March, the Estelle® contraceptive pill also received a positive opinion for Europe, as well as approval for the U.S. market. The Australian Agency is also expected to make a decision by the end of 2021. On the commercial front, all the partners are working together to fine-tune the commercial launch of the contraceptive pill in around 100 countries.

The Donesta® phase III study is nearing completion of recruitment: 2,200 women at more than 200 sites worldwide are enrolled in this E4 Comfort program targeting the treatment of vasomotor symptoms during menopause. For Donesta®, the second Estetrol-based product candidate, the commercial strategy is different from the one of Estelle®. With a strong cash position and a first product at the dawn of its launch, Mithra intends to enhance the Donesta® value by signing a global deal with a single partner.
The pandemic has also led to a new development opportunity in our R&D program: the "Coronesta" program relating to the potential of Estetrol in the treatment of Covid-19 and, more broadly, in the field of respiratory diseases. This Phase II "Coronesta" study aims to investigate the effect of Estetrol on the immune, inflammatory and vascular response of patients (male/ female) infected with Covid-19. It is in line with other international studies, such as the King's College London study which demonstrated the protective effect of estrogens present in the body at high levels. The results of the Coronesta study are expected in early H2 2021.
Despite this unprecedented crisis caused by Covid-19, our teams redoubled their efforts to maintain the tempo and meet the deadlines. One year later, the results are in: Estelle® has obtained its first marketing authorization in Canada, the Donesta® phase 3 study has completed its recruitment phase and an unexpected and promising study has also been added to the R&D pipeline: the Coronesta study. In 2021, Mithra intends to concretize its ambitions in female health and to explore the potential of its Estetrol molecule in other indications.
Launched in the first countries in 2020, the contraceptive vaginal ring Myring® will continue to expand this year in Europe, Chile, Canada and Israel. It is expected to receive marketing approval in the United States in late 2021-early 2021.

For twenty years, Mithra has been committed to offering women new choices through innovation with a focus on contraception and menopause.
From the spin-off of the University of Liege to the listed company with nearly 300 collaborators today, the goal has remained the same : to develop and produce new products offering better efficacy, safety and convenience, meeting women's needs throughout their life span.



12 nationalities
Average age:
20
Since its creation, the R&D and manufacturing platform of Mithra has never hidden its ambitions: to reduce its carbon footprint to the maximum and to use the renewable energies as much as possible. In 2021, the Mithra CDMO will begin the second part of its project and will be able to count on the energy produced by more than 5000 solar panels.
Built in 2016, the Mithra CDMO, which houses Mithra's production areas and laboratories, uses state-of-the-art technology and equipment to meet its continuously reviewed energy goals.
The building was designed with various efficient systems to reduce energy consumption. These include air treatment, containment measures, energy monitoring to optimize the consumption of electrical appliances, heaters, ventilation management, a water recycling system and photovoltaic panels.
Mithra subscribed to the "branch agreements" set up by the Walloon Government and committed itself to improve its energy efficiency and to reduce its CO2 emissions. Following an energy audit carried out in 2019 and the investments made in 2020, the site of Flémalle set up other measures to reach its energy objectives by 2023. Equipped with 1850 solar panels, the Mithra CDMO is preparing to install more than 3000 additional solar panels which should allow to cover 32% of its energy consumption.
Our company is strongly attached to the sustainable development and the reduction of its ecological footprint. In 2021, thanks to the installation of more than 3000 additional solar panels, one third of our energy consumption will be green.
Marie Masoch, ESG Officer
32% green energy
| Solar energy | ||||
|---|---|---|---|---|
| 2020 | 2021 | |||
| Photovoltaic panels | 1850 | 5106 | ||
| Green energy | 9% | 32% | ||



Estetrol (E4) is a native estrogen produced by the human fetus during pregnancy, which passes into the maternal blood at relatively high levels. Due to its unique mode of action, tolerance and safety profile, E4, synthesized from plant sources, could represent a major breakthrough in several therapeutic areas of women's health, particularly in contraception and menopause. This innovative molecule could also prove interesting in other fields of application, such as Covid-19 type diseases, neuroprotection in newborns or wound healing.
Mithra has a unique expertise in the development of complex and innovative products in the fields of contraception, menopause and hormone-dependent cancers. It is one of the few companies in the world that masters polymer technology, which enables a drug's active pharmaceutical ingredient (API) to be distributed at a predetermined rate over a period of time (from 1 month to 5 years). This technology ensures a controlled release of the drug with a minimum of side effects, and is notably used for vaginal rings, implants or intra-uterine devices.

Today, Mithra counts two complementary platforms: its portfolio of innovative products based on Estetrol (E4) and its portfolio of complex therapeutics. The whole supported by the Mithra CDMO, a technological platform which offers a complete range of services covering the entire drug development and production chain.
Contraception A new era in combined
oral contraception

Perimenopause The first complete oral treatment targeting perimenopause
Covid-19 Treatment against Covid-19
Neuroprotection, dermatology
Contraception
Contraceptive vaginal ring made of ethylene-vinyl acetate (EVA) copolymers that releases a combination of hormones

Menopause
Tablet composed of tibolone, a synthetic steroid used for hormone therapy in menopause.
Hormone-dependent cancers
Biodegradable subcutaneous implant indicated for prostate and breast cancer and gynecological indications (endometriosis, uterine fibroids, etc.)
Menopause A next generation of hormone therapy
| Product | Therapeutical area | Phase 1 | Phase 2 Phase 3 | Market approval | ||
|---|---|---|---|---|---|---|
| ESTETROL | Estelle ® |
Contraception | 2021 | |||
| PeriNesta ® |
Perimenopause | 2023 | ||||
| Donesta ® |
Menopause | Q4 2023/Q1 2024 | ||||
| COVID-19 Treatment | ® COVID-19 | 2022 | ||||
| Under development | CNS, dermatology, etc. | Various stages of non-clinical development of future E4-based pipeline |
| Formulation Clinical/BioEq. |
Filing | Market approval | |||
|---|---|---|---|---|---|
| COMPLEX THERAPEUTICS |
Myring ® |
Europe | commercialized | ||
| Contraception | U.S. | Q4 2021/Q1 2022 | |||
| Zoreline ® |
Oncology | 2024 | |||
| Tibelia ® |
Menopause | commercialized |

The many potential applications of Estetrol in the field of health are at the core of the research carried out by Mithra since many years. Estetrol is an estrogen produced by the human fetus during pregnancy which passes in the maternal blood at high levels. Through a complex production process, Mithra managed to reproduce Estetrol and to develop a platform of innovative products dedicated to women' s health. In 2020, Mithra decided to broaden its field of research and to explore the action of this native estrogen in the treatment of coronaviruses like Covid-19.
* Kluft C et al., Contraception 2016. Gerard C et al., Oncotarget 2015 ; 6(19):17621-36. Visser M et al., Horm Mol Biol Clin Invest. 2012 ; 9:95-103. Visser M et al., Climacteric 2008 ; 11 Suppl 1:64-8. Mawet M et al., Eur. J. Contracept. Reprod. Healthcare 2015:1-13. Apter D. et al., Contraception 2016 ; 94(4):366-73. Abot et al., EMBO 2014 : 6 (10) ; Apter et al., Eur. J. Contracept. Reprod. Healthcare 2017 : 22(4).
Prof Jean-Michel Foidart, Permanent Secretary of the Royal Academy of Medicine of Belgium
In 2020, Mithra strengthened its intellectual property with the addition of several patents and patent applications to its Estetrol portfolio. The portfolio now includes 35 patent families filed worldwide, from the synthesis of Estetrol to its use in a wide range of women's health and neuroprotection indications.
Following the promising results of the Estelle® Phase II study on hemostasis, Mithra had filed a patent application in 2018 combining the use of E4 as a contraceptive and the unique safety profile of the E4/DRSP combination. In 2020, this patent application entered national phases and was filed in 29 countries and 3 regions.
The two patent applications filed following the positive results of the Donesta® Phase II study for the effective treatment of vasomotor symptoms have also entered the national phases. Once granted, these patents will consolidate and extend the protection around Donesta®.
In November, Mithra obtained an additional key patent for Estelle® in Europe and Eurasia covering various pharmaceutical compositions, as well as their manufacturing process. This decision guarantees to Mithra the effective exclusivity of Estelle® and Donesta® product candidates until 2036 in Europe. This same patent application was filed in more than 50 other territories.
Finally, Mithra has also strengthened its intellectual property thanks to the issuance of patents protecting different synthesis pathways of Estetrol in different regions of the world (Brazil, Canada, US).
With our 35 patent families, we have built strong intellectual property protection around our Estetrol product portfolio. This strategy preserves our innovations from potential competition in a large majority of countries around the world for several years.
Glwadys Rausin, IP Manager
In November 2020, the European Medicines Agency qualified Estetrol as a New Active Substance. This is the first time in more than 80 years that a new active substance, in this case a new estrogen, has appeared in the field of contraceptive solutions.
Favorable VTE risk profile
Minimal increase in triglycerides
Favorable drug interaction profile
Less breast pain and carcinogenic potential in the presence of E2
Good user acceptability, body weight control, excellent cycle control, improved spotting and general well-being

\$40 billion

Women's Health Market
Either naturally produced by the human body or synthetically, estrogens are commonly found in the aquatic environment. Every year, more than 700kg of the synthetic estrogen EE2, which is present in almost all combined contraceptive pills, are discharged into wastewater. These endocrine disruptors can influence the sexual differentiation of fish and disrupt aquatic ecosystems. At the beginning of 2020, the results of an environmental assessment study indicated the interesting ecological profile of Estetrol.
In these trials conducted on a representative fish species, Estetrol showed none of the adverse effects induced by natural (E1, E2) and synthetic (EE2) estrogens, even at very low concentrations: reduced egg production, decreased testicular growth, delayed maturation, development of male and female genital glands in males, and even feminization. However, the amount of biologically active E4 released into wastewater after human consumption is expected to be considerably lower than those tested in this study. The results also indicate that Estetrol does not accumulate in living organisms and is likely to disappear rapidly from both water and sediment. Further studies are underway at the University of Namur.
In 2020, Mithra submitted the registration files of Estelle®, its combined oral contraceptive composed of 15 mg of Estetrol and 3 mg of drospirenone, to the American (FDA), European (EMA), Brazilian (ANVISA), Australian (TGA), Swiss (Swissmedic) and Russian (Roszdravnadzor) regulatory agencies.
On March 8, 2021, International Women's Rights Day, Mithra obtained the first authorization from the Canadian Authorities. A real milestone in the history of the Belgian biotech. With a commercial launch announced for this summer, Estelle will be the first COC containing a new estrogen marketed on the Canadian market since more than half a century.
Two weeks later, on March 26, 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency gave a positive opinion. Subject to approval by the European Commission, the European marketing authorization is expected to be delivered by the end of the second quarter. On April 15, we received approval for the US market.
In 2020, Mithra has completed its worldwide coverage by signing new marketing agreements for Estelle® with Gedeon Richter for Latin America, third largest market, but also with Mayne Pharma (Australia), Alvogen (Hong Kong and Taiwan) and GyneBio (North Africa). At the same time, it worked with all partners on the implementation of the global marketing and sales strategy for the future contraceptive pill.
The global contraceptive market is worth approximately \$22 billion and is growing at an annual rate of nearly 6%*. The combined oral contraceptive segment is worth approximately \$6.5 billion. Leading sales are the Yaz® (EE/DRSP) family of products, the reference product of Estelle®, which has sales of 1.3 billion euros**.
The Estelle® contraceptive pill has entered its final stretch before its worldwide launch, scheduled for the second half of 2021. Last March, we received the first official approval in Canada, before the positive opinion from the European Medicines Agency. Estelle® is the first Estetrol based product to reach the end of its development, allowing Mithra to write a new page of the Contraception's History.

* Market Transparency Research 2017 ** IMS Health, 3rd quarter 2017
The first world approval means so much to a researcher. This accomplishment is the culmination of a huge team effort and passionate individuals. Only a few people can boast of being part of bringing an innovative product to market in a career. We are so proud of the journey we have made, the victories we have won and the obstacles we have overcome that have brought us to where we are today.
Maud Jost, E4 Program Director

+6% growth

Launched in late 2019, the Donesta® Phase III clinical program for the treatment of vasomotor symptoms in postmenopausal women continued its progress in 2020. The program "E4 Comfort" aims to enroll approximately 2,200 postmenopausal women in two pivotal studies.

From the beginning of the Covid-19 outbreak, Mithra implemented a global plan of Safety Management within the active sites and took many initiatives to ensure the good progress of the study while guaranteeing the safety of the patients. At the end of 2020, the independent Data Safety Monitoring Board (DSMB) gave the green light to continue the study and confirmed the safety profile of Estetrol. The clinical program is currently on track and is expected to complete enrollment in the first half of 2021.
Depending on the Covid-19 and regulatory approvals, Mithra expects to obtain marketing approval for Donesta® in late 2023, early 2024. With the recent consolidation of Mithra's Estetrol patent portfolio, Donesta® is protected until 2036 in Europe, with a similar patent application filed in the United States.
The major financing operations carried out in 2020 for a total of € 260 million allowed us to reinforce Donesta®

commercial development strategy targeting a single global partner leader in women's health. Thanks to its solid cash position and the first approvals for Estelle®, Mithra can afford to advance in its clinical program in order to better valorize its product candidate targeting the menopause market. This fast growing market represents today about \$ 13 billion and should reach about \$ 16 billion by 2025.
While nearly 8 out of 10 women suffer from vasomotor symptoms, 10% of them receive hormonal treatment to alleviate menopausal symptoms. This is due to a concern about the safety of currently available hormonal treatments. But also the lack of an innovative treatment that would act on both hot flashes as well as on the many undesirable side effects associated with the estrogen deficit during menopause. Given its unique mode of action, Donesta® is emerging as a next-generation alternative addressing the unmet needs of all these women.
| C302 Study | C301 Study | |
|---|---|---|
| United States and Canada | 14 countries in Europe, Russia, Americas |
|
| 1000 menopausal women | 1200 menopausal women | |
| 120 sites | 120 sites | |
Multicenter, randomized, double-blind, placebo-controlled design
Primary objective: to measure the effects of treatment with 2 doses of E4 (15 mg and 20 mg) on the frequency and intensity of moderate to severe MSV after 4 and 12 weeks of treatment.
Secondary objectives: to assess the effects of treatment on a range of important efficacy and safety parameters.
The positive opinion of our independent expert committee confirms the safety profile of Estetrol in addition to the data already obtained for the Estelle® contraceptive. Thanks to our efforts since the beginning of the health crisis, we are continuing our clinical program as planned, with results expected in the first half of 2022. We remain confident in the promising potential of Donesta® as a next-generation alternative addressing the unmet needs of postmenopausal women.
Mélanie Taziaux,
Donesta Project Director

The Covid-19 pandemic has shaken our habits and put pressure on our flexibility. But it has also brought new challenges to Science. It has led us to review our R&D pipeline and to identify a new development opportunity: the "Coronesta" program relating to the potential of Estetrol in the field of respiratory diseases.
Since the beginning of the health crisis, epidemiological studies indicate that Covid-19 affects more men than women, and more severely. This gender disparity could be explained by biological differences in the immune system, as already demonstrated in other infectious diseases caused by human coronaviruses, such as severe acute respiratory syndrome (SARS). Estrogens would play a protective role by acting on a protein called "angiotensin-converting enzyme 2" or ACE2, which serves as a gateway for some coronaviruses, such as the one that causes Covid-19, to enter human cells.
Mithra has therefore decided to launch a phase II study "Coronesta" on the effect of Estetrol on the immune, inflammatory and vascular response of patients (men/women) infected by Covid-19. It is in line with other international studies, such as the one from King's College London which demonstrated the protective effect of estrogens present in the body at high levels. The results of the Coronesta study are expected in the second half of 2021.
The PeriNesta® program targets perimenopause, an intermediate phase that affects women between reproductive age and the beginning of menopause. It concerns women in their forties who have decreased fertility but still require effective contraception. Perimenopause is characterized by persistent irregular menstrual periods, severe fluctuations in hormone levels, frequent anovulation and the appearance of vasomotor symptoms. Many women also experience depressive symptoms such as mood swings, irritability and poor concentrating. Currently, there is no approved product providing both effective contraception tailored to the premenopausal woman's profile and relief of vasomotor symptoms.
Although the clinical program has not yet been launched, the previously announced opportunistic development is still ongoing, together with other development strategies under consideration to full leverage the potential of this product candidate.
Estetrol also has orphan drug status for the treatment of hypoxic ischemic encephalopathy (HIE). This severe form of neonatal asphyxia affects approximately 30,000 newborns each year in Europe and the United States. It is caused by a reduced blood or oxygen supply to the baby's brain before, during or just after birth. Nearly one in four affected infants will die before leaving the neonatal intensive care unit. Among surviving infants, there are severe neurological problems and long-term disability are observed. Currently, infants are treated with therapeutic hypothermia or 'cooling' to reduce brain damage, but this treatment has limited efficacy and comes at high cost.
Given its significant mortality and morbidity in newborns and the lack of available therapeutic alternatives, the development of a new Estetrol-based treatment could address a real unmet medical need.
We want to remain a biotech company dedicated to developing and manufacturing innovative treatments. Estetrol can have many potential applications in women's health, but also in other areas such as the central nervous system, infectious diseases, dermatology,... We have not finished exploring its full potential!
Jean-Manuel Fontaine VP External & Scientific Affairs


Successfully launched in 2019, the Myring® contraceptive vaginal ring has continued the momentum and reached pharmacies in several European countries, including Germany, the second largest market in the world.
In total, Mithra has licensed Myring® covering 39 countries, including major markets such as the United States, Germany and Italy. In 2020, Mithra signed new agreements with Gynial (Switzerland), Zentiva (France, Poland and the UK), Megalabs (Mexico) and Chemical Dampe (Venezuela). All these contracts provide for the production of the vaginal contraceptive at Mithra CDMO, which managed to maintain its production schedule in 2020 despite the health situation. The approval of the American regulatory authorities is awaited for the end of 2021-beginning of 2022, for commercialization in the United States by Mayne Pharma.


Ø 4 mm After all these years of research and development, we are particularly happy and proud to see our contraceptive ring in European pharmacies! With the benefit of an additional one-year shelf life compared to other rings and at room temperature, Myring is both more convenient and economical for pharmacists and users.
Kathy Van Butsele, C MC Project Manager
Myring® is a fexible contraceptive vaginal ring, made of ethylene vinyl acetate copolymers, and is bioequivalent to NuvaRing®.


Already marketed in about 40 countries, Tibelia® took a crucial step in its commercial expansion in 2020 by becoming the first tibolone-based hormone treatment available in Canada. This is a first major step on the North American continent.
Developed by Mithra as a bioequivalent version of Livial®, Tibelia® is a synthetic steroid that relieves menopausal symptoms and prevents osteoporosis in postmenopausal women at high risk of future fractures and intolerant to other drugs. Thanks to a longer shelf life than the original, Tibelia® has a significant competitive advantage.
The commercial launch in Canada in July 2020 marks the first launch of a tibolone product in North America and is expected to facilitate access to the neighboring U.S. market, where no tibolone product yet exists in the € 2.5 billion* menopause market. In 2020, Italy, Switzerland and Liechtenstein were also added to the nearly 40 countries marketing Tibelia®.
Hormonal treatment options previously available in Canada are often accompanied by side effects. As a result, many women discontinue therapy. Tibolone has been used in Europe for many years and has a proven efficacy, tolerability and safety profile.
Dr Robert Reid, Professor of Gynecology
at Queen's University (Canada)


Based on polymer technology, Zoreline® is a subcutaneous implant for the treatment of breast and prostate cancer, as well as other gynecological conditions such as endometriosis and uterine fibroids.
Zoreline® is a biodegradable injectable implant based on goserelin, a luteinizing hormone-releasing hormone agonist, used to treat prostate cancer, breast cancer and benign gynecological indications. This implant is currently under development (pharmacodynamic studies) for two formulations (1 and 3 months).
Zoreline® represents a significant business opportunity in a market dominated exclusively by Zoladex®, with worldwide sales of nearly € 630 million**. To date, except in a few Eastern European countries, no generic version has been approved, which demonstrates the complexity of clinical development of such a drug.
** IQVIA 2018
38 39
The Mithra CDMO has perfectly succeeded in its transition to the commercial production phase and respected the order books despite the health crisis. In total, more than 750,000 Myring® rings have left our Belgian production center for European pharmacies. The Mithra CDMO will continue its expansion in 2021 with the accreditation of its new injectable production area.

Launched in 2019, the production of the Myring® contraceptive vaginal ring has been on track and fulfilled all orders placed by European distributors. Since the start of the Covid-19 crisis, the Belgian plant has maintained its production cycles according to schedule, in strict compliance with the hygiene and social distancing measures imposed by the authorities. In total, more than 750,000 rings have reached European pharmacies.
Alongside the steadily increasing commercial production of Myring®, Mithra CDMO has also been preparing for the upcoming commercialization of the Estelle® contraceptive pill while finalizing the certification program for its ultra-modern injectable production line. This new area should be operational from the second half of 2021 and could notably allow the production of various forms of injectables, in particular vaccines.
After 5 years of operation, the production center of Mithra should also reached an important objective of its environmental policy. Thanks to the placement of a little more than 3,000 additional solar panels, the site should pass the mark of one third of green energy on its total consumption of electricity per annum.

We have a brand new, state-of-the-art pharmaceutical infrastructure that already boasts real expertise in the development of complex products. Our CDMO can rely on a pool of incredible young talents fully commited to earn the trust of our partners.
Renaat Baes, Plant Manager

| Year ended 31 December | ||||
|---|---|---|---|---|
| 2020 | 2019 | |||
| Revenues | 9,030 | 96,520 | ||
| Cost of sales | (3,457) | (2,487) | ||
| Gross profit | 5,573 | 94,033 | ||
| Research and development expenses | (69,310) | (52,576) | ||
| General and administrative expenses | (8,126) | (8,699) | ||
| Selling expenses | (1,251) | (2,044) | ||
| Other operating income | 6,574 | 6,936 | ||
| Total operating expenses | (72,113) | (56,383) | ||
| REBITDA* | (66,540) | 37,650 | ||
| Share-based payments expenses | (7,267) | (4,898) | ||
| EBITDA** | (73,807) | 32,752 | ||
| Depreciation | (6,136) | (5,777) | ||
| Non-recurring items | (3,734) | |||
| Operating loss | (83,678) | 26,975 | ||
| Change in fair value*** of contingent consideration payable | (18,114) | (54,728) | ||
| Net fair value gain/(losses) on financial assets at fair value through profit or loss |
(4,925) | 2,763 | ||
| Financial income | 1,782 | 271 | ||
| Financial expenses | (5,987) | (6,705) | ||
| Loss before taxes | (110,922) | (31,424) | ||
| Income taxes | 18,835 | 4,859 | ||
| Net Loss for the period | (92,086) | (26,564) | ||
| Attributable to | ||||
| Owners of the parent | (92,086) | (26,564) | ||
| Non-controlling interests | ||||
| Profit / (Loss) per share | ||||
| Basic loss per share (in Euro) | (2.25) | (0.70) | ||
| Diluted loss per share (in Euro) | (2.25) | (0.70) |
* EBITDA is an alternative performance measure calculated by excluding the depreciations & amortization from EBIT (operating loss) from the consolidated statement of income prepared in
accordance with IFRS. ** REBITDA is an alternative performance measure calculated by excluding the non-recurring items and the depreciation & amortization from EBIT (operating loss) from the consolidated statement of
income prepared in accordance with IFRS. *** Fair values are computed on the contingent considerations payables which are reported under Other financial loans (p.)
Figures presented below (in thousands of Euro) are management figures
In 2020, we diversified our financial resources and strengthened our balance sheet structure through various financing operations for an amount of EUR 260 million, which in a volatile year testifies to investors' confidence in our company.
We have a record level of cash, very high levels of equity and very strong solvency indicators. 2020 could have been a year with strong growth in Ebitda if we had sold the first licenses of Donesta®. But our strategy is clear: we have the capacity to seek a global partner for this second product based on the same active principle as Estelle®. The longer we wait, the more data we generate in our Phase III study and the more Donesta® increases in value. Christophe Maréchal, Chief Financial Officer
Over EUR 300 million in cash to be collected for Estelle®
Record cash flow of EUR

Regular access to capital markets : € 260 M secured in 2020

EUR 65 million Capital increase by means of a private placement


Mithra (Euxonext: MITRA) is listed on Euronext Brussels and is part of the BEL Mid index. The group is also part of the BEL Health Care and Euronext 150 indices.
In 2020, the average share price was € 20.4 per share. The highest level was € 27.1 on February 12 and the lowest level € 13.8 on March 12. With a market capitalization of € 841.5 million as of 31.12.2020 and an average daily volume published by Euronext of 61 366 shares, Mithra has sufficient liquidity to be on the radar of major institutional investors.

March 12, 2020
Total number of shares with voting rights:
42,714,097

This graph shows our current shareholder structure as of December 31, 2020, based on the transparency declarations made by shareholders. Notification obligations are required by Belgian law or according to Mithra's articles of association, when the shareholding exceeds the thresholds of 3%, 5% or any multiple of 5%.
April 20, 2021: 2020 Annual Report
March 9, 2021: Annual results 2020




Benoît Louage

Vranken
Alex Cogut
Pierre-Alexandre Desir
Christophe Dombu
Mithra interacts with the institutional investors during roadshows and conferences to which the members of the Executive Management take part with the person in charge of the investor relations. These international roadshows and conferences allow to establish a dialogue and to meet the community of the investors in order to present the financial performances and Mithra strategy.
In 2020, Mithra participated in 14 events, for the most part virtual, during which the Executive Management met investors located in Europe, North America as well as in Asia.
Each investor has the possibility to subscribe to a newsletter on the Company's corporate website in order to receive press releases. The investor relations can be reached at [email protected] and answers all questions and requests for information.
As of December 31, 2020, Mithra was covered by six sell-side analysts who publish regular reports on the stock. Besides the regular individual exchanges, Mithra organizes two webinars at the time of the publication of its half-year/annual results. The Management of the company participates in these conference calls in order to present the financial and strategic performances of the company. These conferences are accessible to all the investors and available in replay on Mithra website.


Mr. Hoffman holds a Master's degree in Applied Economics from Ghent University and an MBA from Vlerick Business School.
In 1992, he started his career in the corporate finance department of KBC Bank, before joining KBC Securities in 2000, where he served as CEO from 2012 to 2016. In parallel, he is also a member of the supervisory board of KBC IFIMA and Patria Securities, as well as a member of the board of directors of Omnia Travel Belgium. Since 2016, Mr. Hoffman has been CEO of Value Square and an independent director of Fagron, Greenyard, SnowWorld and MDxHealth.
Erik Van Den Eynden graduated in Economics at the University of Antwerp and has more than 30 years of experience in the banking sector.
He joined ING in 1990, where he held various commercial and management positions, including District Manager, Head of MidCorporates & Institutionals, CEO of ING Insurance Belgium & Luxembourg. From 2017 to 2020, he held the position of CEO of ING Belgium.
In March 2021, Mr. Van den Eynden became CEO of the Straco Investment Group active in real estate project development, investments and private equity.
Ajit Shetty holds an MSc and PhD in Metallurgy from Cambridge University and an MBA from Carnegie-Mellon University.
He started his career in 1976 at Janssen Pharmaceutica, where he held various positions in Finance and Business Development. He was instrumental in developing Janssen into a worldwide multinational within Johnson & Johnson. He served as President of Janssen USA from 1984 to 1990, before becoming Executive Vice President Finance of Janssen Belgium. From 1999 to 2008, he served as Managing Director of Janssen and as Chairman from 2004, while also serving on the Johnson & Johnson Operating Committee.
Elected "Manager of the Year" in Flanders in 2004, he was made a baron by King Albert II of Belgium in 2007. He is chairman of the Flemish Institute for Biotechnology (VIB) and a member of the board of directors of various pharmaceutical companies in Belgium, the United States and China. He is also a trustee of Carnegie-Mellon University.


Patricia van Dijck holds a degree in medicine and a specialization in clinical biology and pharmaceutical medicine from the Catholic University of Louvain (UCL).
She began her career in the pharmaceutical industry in 1996 as an International Medical Advisor at UCB. She then became Medical Director at Lundbeck, before being appointed Managing Director in 2007. In 2011, Mrs. van Dijck joined Novartis Belux as Head of Market Access & Public Affairs, before joining the mother company in Basel in 2014 as Head Patient Access Excellence. Three years later, she became Project Lead of an IMI project of European private-public partnership in hemato-oncology, in Milan. Since 2018, she has been working for GSK Belux as Market Access & Public Affairs Director.


Jean-Michel Foidart graduated in Gynecology from the University of Liège and also obtained a PhD in cell biology and biochemistry, before directing its Department of Gynecology-Obstetrics. He was also General Secretary of the European Society of Gynecology and member of multiple editorial boards of international peer-reviewed journals. He is the author of more than 1300 publications on women's health and experimental oncology.
Professor Foidart holds the Francqui Chair, Doctor Honoris Causa of the Pierre and Marie Curie University of Paris and the Paul Sabatier University of Toulouse. He is Officer of the Order of Leopold II, Commander, then Grand Officer of the Order of the Crown, Professor Extraordinary, Honorary of the ULg and Perpetual Secretary of the Royal Academy of Medicine of Belgium. He is the co-founder of Mithra.
Mr. Servais graduated in economics from the University of Liege, where he started his career as a research assistant. In 1995, he joined the Federal Planning Bureau as an expert and later the Economic and Social Council of the Walloon Region. In 2001, he became Chief of Staff for several ministers of the Walloon government.
Since 2007, he has been CEO of the Liège-based investment fund Noshaq, which offers financing solutions for the creation and growth of companies.
A graduate of HEC Paris and Columbia Business School, Christian Moretti began his career in Finance at Paribas (Industrial Department) where he was active for over 10 years. He then founded Dynaction, an industrial holding company listed on the Paris Stock Exchange, before focusing on the development of one of its subsidiaries, PCAS Biosolution, a European leader in the chemistry of complex molecules employing more than 1,000 people worldwide, with pharmaceutical subcontracting accounting for 60% of its overall activity. He held the position of President of Operations for 13 years.
Christian Moretti was also Professor of Finance at ESCP Europe Campus Paris and represented France at CEFIC (European Chemical Industry Council) in Brussels.

François Fornieri is a chemical engineer (ISIL) with a Master's degree in Management (HEC). He has over 30 years of experience in the pharmaceutical industry. He began his career at Sanofi, before joining the Marketing department of the Bayer-Schering group. In 1999, he founded Mithra and ensures the direction of the company during nearly 20 years. He is also the co-founder of Uteron Pharma, which he sold to the American group Watson-Actavis (2010-2013).
Elected "Manager of the Year" in Wallonia in 2011, Mr. Fornieri is also an Officer of the Walloon Order of Merit and won the Essenscia Innovation Award in 2019. Former vice president of the Union Wallonne des Entreprises, he is president of Protection Unit, Millesime Chocolat and the Business Club B19 Liège.


Leon Van Rompay Chief Executive Officer
Jean-Michel Foidart President of the Scientific Council
Christophe Maréchal Chief Financial Officer
Cedric Darcis Legal Manager
Graham Dixon Chief Scientific Officer

Laurence Schyns Human Resources Director
Benjamin Brands Chief Supply Chain Officer Renaat Baas Plant Manager
Frederic Constant Corporate QA Director
Jean-Manuel Fontaine VP External & Scientific Affairs Maud Vanderthommen Communication Manager
Benoît Mathieu Investor Relations Officer

| 1. | Report of the Board of Directors 57 | ||
|---|---|---|---|
| 1.1. | Analysis of results / operations 57 | ||
| 1.2. | Statement of financial position analysis 58 | ||
| 1.3. | Cash flow analysis59 | ||
| 1.4. | Corporate governance statement59 | ||
| 1.5. | Transactions within the authorized capital 78 | ||
| 1.6. | Acquisition of own Securities 79 | ||
| 1.7. | Use of financial instruments by the Group as per art. 3:6 CCA 79 | ||
| 1.8. | Circumstances that could considerably affect the development of the Group79 | ||
| 1.9. | Research and development84 | ||
| 1.10. | Conflicting interests of Directors (Art. 7:96 of the CCA)85 | ||
| 1.11. | Independence and expertise of at least one member of the Audit committee 102 | ||
| 1.12. | Going concern assessment 103 | ||
| 1.13. | Appropriation of results 103 | ||
| 1.14. | Important events after the reporting period 103 | ||
| 1.15. | Grant of discharge to the directors and the statutory auditor 104 | ||
| 2. | Responsibility statement 105 | ||
| 3. | Auditor report106 | ||
| 4. | Consolidated Statement of Profit and Loss 111 | ||
| 5. | Consolidated statement of comprehensive loss 112 | ||
| 6. | Consolidated Statement of Financial Position 113 | ||
| 7. | Consolidated statement of changes in equity 114 | ||
| 8. | Consolidated Cash Flow statement 115 | ||
| 9. | Notes to the consolidated financial statements 116 | ||
| 9.1. | General Information 116 | ||
| 9.2. | Summary of Significant Accounting Policies 117 | ||
| 9.3. | Financial Risk Management 128 | ||
| 9.4. | Critical Accounting Estimates and Judgements 131 | ||
| 9.5. | Business combinations and asset deals 133 | ||
| 9.6. | Segment Information 133 | ||
| 9.7. | Other Intangible Assets 134 | ||
| 9.8. | Property, plant and equipment 136 | ||
| 9.9. | Goodwill & IP R&D 136 | ||
| 9.10. | Other non-current assets 138 | ||
| 9.11. | Inventories 138 | ||
| 9.12. | Trade Receivables and other current assets 138 | ||
| 9.13. | Cash and cash equivalents 139 | ||
| 9.14. | Equity 139 | ||
| 9.15. | Financial liabilities 141 | ||
| 9.16. | Trade payables and other current liabilities 147 | ||
| 9.17. | Financial instruments 147 | ||
| 9.18. | Revenue 153 | ||
| 9.19. | Other operating income 155 | |
|---|---|---|
| 9.20. | Expenses by nature 155 | |
| 9.21. | Employee benefit expenses 156 | |
| 9.22. | Retirement benefit schemes 156 | |
| 9.23. | Financial income and expense 157 | |
| 9.24. | Income tax 157 | |
| 9.25. | Result per share 159 | |
| 9.26. | Share-based payments 159 | |
| 9.27. | Leases 161 | |
| 9.28. | Contingencies and arbitrations 162 | |
| 9.29. | Commitments 163 | |
| 9.30. | Related party transactions 163 | |
| 9.31. | Events after the reporting period 165 | |
| 9.32. | Mithra Pharmaceuticals companies consolidation scope 166 | |
| 9.33. | Disclosure audit fees 168 | |
| 9.34. | Condensed statutory financial statements of Mithra SA 169 | |
| 9.35. | Alternative performance measure 171 |
The net loss for the year 2020 was EUR 92,086k (loss of EUR 26,564k for 2019) on a consolidated basis.
The operating loss of EUR 83,678k in 2020 compared to the operating profit EUR 26,975k in 2019 is mainly explained by the decrease of revenues and the increase of R&D activity.
The loss before taxes amounts at EUR 110,922k in 2020 as a result of the increase in the fair value of contingent consideration liabilities (earnouts) for EUR 18,114k.
Group revenues decreased to EUR 9,030k in 2020 (EUR 96,520k in 2019) and are mainly driven by product sales, including the first sales of Myring® and by Estelle® out-licensing fees in Latin America (Latam). On the one hand, no significant additional performance obligations were considered as highly probable by Mithra, meaning that no revenue on backlog of signed contracts was recognised. On the other hand, no significant partnership was signed during 2020. This reflects the business development strategy for Donesta®, which is progressing well, targeting major global partners. At the same time, we are generating more data in the Phase III trial to be able to conclude a higher deal value.
R&D expenses increased by 37% in 2020 to EUR 78,458k (2019: EUR 57,073k) due to the ramp up of the Donesta® Phase III "E4 Comfort" clinical program and the Covid study, launched in the second half of 2020. R&D expenses for Donesta® should continue to increase in the first half of 2021.
G&A increased mainly due to booking entries related to share-based payment expenses of EUR 7,267k in 2020, a non-cash element. Without this non-cash element, G&A decreased by EUR 1,210k compared to 2019, while the rampup of activities was important over the period.
Other operating income is rather stable and mainly composed of R&D tax credit and grant income.
The increase in the fair value of contingent consideration liabilities (earnouts) for EUR 18,114k impacts profit and loss below operating loss, a far lower impact than previous year change in fair value of contingent consideration payable (EUR 54,728k). The fair value is determined using a probability weighting approach applied to earnouts cash flows (based on cash position at year-end on going forward) which are discounted.
The loss before taxes are also impacted by the adjustment of the fair value on Mayne's contract assets (nonmonetary part) for EUR 4,925k (for the second equity tranche at FDA approval). In 2019, the adjustment of the fair value on Mayne's contract assets (EUR 5,236k) was offset by recognition of consideration contingently receivable from Ceres for EUR 7,999k.
Financial income increased by EUR 1,511k and is mainly explained by the realized exchange gain on foreign USD exchange contract (related to a forecasted transaction that has already occurred).
Financial expenses are mainly resulting from interest paid (EUR 3,503k), unrealized foreign exchange losses (EUR 828k) and a cumulative catch-up adjustment to the amortized cost of government advances (EUR 1,355k).
The Company has no branches. Refer to detailed table about the group structure in note 9.32.
Total assets increased to EUR 521,985k as of 31 December 2020 (EUR 397,643k at the end of previous year).
As of 31 December 2020, the Statement of financial position shows a total of EUR 283,509k in Non-current assets, the largest of which are Other intangible assets (EUR 89,005k), Deferred tax assets (EUR 50,904k), Right-of-use assets (EUR 69,572k) and Property, plant and equipment (EUR 29,921k).
Tangible fixed assets (Property, plant and equipment and the Right-of-use assets) increased EUR 5,456k, mainly relating to machinery and equipment of the new production facility (Myring® equipment) for the manufacturing of pharmaceuticals products (Mithra CDMO) and their related development costs for machine settings and improvement.
Other intangible assets consist mainly of a portfolio of acquired product rights, market access rights and internally generated intangible assets. Note that Donesta® qualified as an asset deal, for EUR 8,000k. The book value mainly relates to Estelle® for an amount of EUR 30,600k, to Zoreline® for an amount of EUR 24,400k, and to Myring® for an amount of EUR 11,400k. Over 2020, EUR 4,794k has been added to the Other intangible assets as a result of a capitalization of development costs related to the project "E4 synthesis" and the project Estelle® since the filing of the application for market authorization occurred in the first half of the year and management has judged that registration is highly probable. Those additions are offset by impairment costs on license rights acquired from GSP (EUR 3,450k).
Deferred tax assets increased EUR 16,474k mainly due to the recognition of additional assets arising from available tax losses carried forward.
Non-current Contract assets were transferred to current assets, as the main trigerring event for invoicing is expected for 2021.
Since 2020, the Group uses derivative financial instruments to manage its exposure to foreign exchange rate risk arising from operational activities (cash flow hedges). Those are recorded at fair value on balance sheet (EUR 6,184k within non-current assets and EUR 2,881k within current assets based on maturities of hedging contracts).
As of 31 December 2020, the Statement of financial position shows a total of EUR 238,475k in Current assets, mainly Cash and cash equivalents of EUR 138,675k (EUR 88,955k higher than previous year). The convertible bond of EUR 125 million combined with the private placement via an accelerated bookbuild offering of EUR 65 million, the capital commitment line with LDA Capital Limited for up to EUR 50 million (EUR 3.2 million drawn down to date), and a committed bank loan of EUR 20 million until June 2022 (fully undrawn), allowed Mithra to secure the necessary financial resources to finance its business development strategy, and to carry on its R&D expenses.
Inventories increased to EUR 35,382k from EUR 16,277k in 2019, in the context of Estelle® commercial launch preparation.
Total Equity at year-end decreased to EUR 157,737k from EUR 163,298k in 2019, mainly due to the total comprehensive loss for the period (EUR 89,086k), partially offset by the capital increases of EUR 65,168k, the value of conversion rights on convertible bonds (EUR 11,091k) recognized as an equity component and share-based payment expense (EUR 7,267k).
Non-current liabilities increased to EUR 293,500k at the end of year 2020, compared to EUR 186,546k in 2019, primarily due to convertible bond debt, net of transaction costs (EUR 105,997k and EUR 5,313k respectively as noncurrent and current portion of other loans).
Current liabilities increased to EUR 70,747k at the end of 2020, compared to EUR 47,800k in 2019. The increase of the current liabilities is the result of an increase of the fair value of earnout debt related to Estelle for EUR 18,114k (Other financial liabilities) and the current portion of convertible bond debt.
Full year cash flow of the group amounts to EUR 88,955k :
The strong cash position recorded at 31 December 2020 (EUR 138,675k) will allow the Group to keep up with operating expenses and capital expenditure requirements at least until the end of 2021.
Based on their assessment, the Management and Board of Directors consider it appropriate to prepare the financial statements on a going concern basis. The assessment is based on expected R&D clinical results and further business deals as well as on the monitoring of our funding activities.
The uncertainly raised by the COVID-19 pandemic is not impacting going concern. Although there are lot of uncertainties, it does not impact the Company's ability to continue operations during the next twelve months.
This Corporate Governance Statement is included in the Company's report of the Board of Directors on the statutory accounts for the financial year ended on 31 December 2020 in accordance with Article 3:6, §2 of the Belgian Companies and Associations Code.
On 17 May 2019, the Belgian royal decree of 12 May 2019 designating the corporate governance code to be complied with by listed companies was published in the Belgian Official Gazette. On the basis of this royal decree, Belgian listed companies are required to designate the new 2020 Belgian Corporate Governance Code (the "2020 Code") as reference code within the meaning of Article 3:6, §2 of the Belgian Companies and Associations Code of 23 March 2019 (as amended) (the "Belgian Companies and Associations Code"). The 2020 Code applies compulsorily to reporting years beginning on or after 1 January 2020 (compulsory application).
The 2020 Code is available on the website of the Belgian Corporate Governance Committee (www.corporategovernancecommittee.be).
The Corporate Governance of the Company is organized pursuant to the Belgian Companies and Associations Code, the Company's articles of association and the Company's Corporate Governance Charter.
The Company's Corporate Governance Charter was adopted by the Board of Directors on 20 April 2020 and updated on 22 April 2020. It was drafted in accordance with the recommendations set out in the 2020 Code.
For the financial year ended on 31 December 2020, the Company complied to a large extent with the provisions of the 2020 Code, except for the following deviation which the Company believed was justified in view of the Company's specific situation. Notably, in line with the "comply-or-explain" principle of said 2020 Code, the Company did not fully comply with the following provision:
• Provisions 4.10 to 4.16 of the 2020 Code: the Company decided not to appoint a formal internal auditor because of the size of the Company. However, the Risk and Audit Committee regularly evaluates the need for this function and/or commissions external parties to conduct specific internal audit missions and report back to Board of Directors.
The Company's Corporate Governance Charter, together with the articles of association of the Company, are available on the Company's website (www.mithra.com), mentioning the date of the most recent update, in a clearly recognizable part of the Company's website under the heading "Investors", separate from the commercial information.
On the date of this report, the share capital of the Company amounts to EUR 31,270,872.40 and is fully paid-up. It is represented by 42,714,097 ordinary shares, each representing a fractional value of (rounded) EUR 0.7321 and representing one 42,714,097th of the share capital. The Company's shares do not have a nominal value. The Company's shares are admitted to listing and trading on the regulated market of Euronext Brussels, under the ticker "MITRA".
In addition to the outstanding shares, the Company has a number of subscription rights, that are exercisable into ordinary shares, consisting of:
The shares of the Company can take the form of dematerialized shares. All the Company's shares are fully paid-up and are freely transferable. All of the 42.714.097 existing shares have been admitted to trading on the regulated market of Euronext Brussels.
The Company's shares do not have a nominal value, but each reflect the same fraction of the Company's share capital, which is denominated in euro.
Each shareholder of the Company is entitled to one vote per share. Shareholders may vote by proxy, subject to the rules described in the Company's articles of association.
Voting rights can be mainly suspended in relation to shares:
Pursuant to the Belgian Companies and Associations Code, the voting rights attached to shares owned by the Company, or a person acting in its own name but on behalf of the Company, or acquired by a subsidiary of the Company, as the case may be, are suspended.
All of the shares of the Company entitle the holder thereof to an equal right to participate in dividends in respect of the financial year ending 31 December 2020 and future years. All of the shares participate equally in the Company's profits (if any). Pursuant to the Belgian Companies and Associations Code, the shareholders can in principle decide on the distribution of profits with a simple majority vote at the occasion of the annual general shareholders' meeting, based on the most recent statutory audited financial statements, prepared in accordance with Belgian GAAP and based on a (non-binding) proposal of the Company's Board of Directors. The Belgian Companies and Associations Code and the Company's articles of association also authorise the Board of Directors to declare interim dividends without shareholder approval. The right to pay such interim dividends is, however, subject to certain legal restrictions.
Additional financial restrictions and other limitations may be contained in future credit agreements.
The table below provides an overview of the shareholders that notified the Company, of their shareholding in the Company pursuant to applicable transparency disclosure rules, as of 31st of December 2020.
| Shareholder | % of voting rights1 |
|---|---|
| Mr François Fornieri2, 4 | 26.13% |
| Mr Marc Coucke3 4 | 15.13% |
| NOSHAQ (Meusinvest SA) 4 | 11.88% |
| Scorpiaux B | 3.89% |
| Ogesip Invest SA | 2.77% |
The percentage of voting rights is calculated as per the closing date and taking into account the total number of outstanding shares of the Company as of such date
François Fornieri holds in direct and through Yima SRL warrants entitling him to subscribe still 1,775,790 additional shares of Mithra.
3. Marc Coucke holds his shareholding partially through Alychlo NV, which he controls.
4. François Fornieri, Alychlo NV and Noshaq SA jointly hold 300,000 warrants (share lending warrants).
No other shareholders, alone or in concert with other shareholders, notified the Company of a participation or an agreement to act in concert in relation to 3% or more of the current total existing voting rights attached to the voting securities of the Company.
The most recent transparency declarations, including the abovementioned declarations, are available on the company's website www.mithra.com.
To the Board of Directors' best knowledge, no shareholders' agreement exists among shareholders of the Company with respect to the Company.
The Company has opted for a "one tier" governance structure whereby the Board of Directors is the ultimate decision making body, with the overall responsibility for the management and control of the Company, and is authorized to carry out all actions that are considered necessary or useful to achieve the Company's object. The Board of Directors has all powers except for those reserved to the general shareholders' meeting by law or the Company's articles of association. The Board of Directors acts as a collegiate body.
On the 31st December 2020, the Board of Directors consisted of eight (8) members (with a minimum of three (3) members set out in the articles of association), of which two (2) are Executive Directors and six (6) of which are Non-Executive Directors, including four (4) Independent Directors in the meaning of article 7:87 of the Belgian Companies and Associations Code.
On initiative of Alychlo NV, the Board of Directors decided to renew its composition in accordance with its strategic operational plan to add new profiles whose expertise and competence in the pharmaceutical and financial sector will contribute to ensure the quality and relevance of the directions taken in the development of the Company's commercialization phase. In that respect, Alychlo NV and Aubisque BVBA, CG Cube S.A., P4Management BV, P.Suinen SRL, Castors Development SA and Noshaq Partners SCRL, resigned from all their mandates within the Company with effect as from the 25 November 2020.
As a result, the Board of Directors coopted the following directors to fill in the vacancy seats pursuant to provision 7:88 §1 of the BCAC:
On 3 February 2021, the Board of Directors accepted that Yima SRL (represented by Mr. François Fornieri) take a step back as CEO, until further notice, for a maximum of 12 months. For further information, please see the press release published by the Company on 4 February 2021 on its website (https://investors.mithra.com/en/pressreleases/).
The roles and responsibilities of the Board of Directors, its composition, structure and organization are described in detail in Company's articles of association and Company's Corporate Governance Charter (available on the Company's website, www.mithra.com). The Company's Corporate Governance Charter specifies the criteria that Directors must satisfy in order to qualify as Independent Directors.
Since the General Shareholders' Meeting of 16 May 2019, Directors are appointed for a maximum term of two years, which isrenewable.
| The composition of Mithra's Board of Directors was asfollows | during the financial year 2020: | |||||
|---|---|---|---|---|---|---|
| -------------------------------------------------------------- | -- | -- | -- | -- | -- | --------------------------------- |
| Name | Position | Term 1 | Nature of Mandate |
Board of Directors Committee Membership |
Attendance² to 2020 Board meetings |
|---|---|---|---|---|---|
| Yima SRL (permanent representative: Mr. François Fornieri) |
Managing Director |
2021 | Executive | - | 14/15 |
| Sunathim BV (permanent representative: Mr. Ajit Shetty) |
Director | 2021 | Independent | Nomination and Remuneration Committee |
3/15 (3/3) |
| TicaConsult BV (permanent representative: Mr. Erik Van Den Eynden) |
Director | 2021 | Independent | Risk and Audit Committee (Chair) |
3/15 (3/3)) |
| CG Cube S.A. (permanent representative: Mr. Guy Debruyne) |
Director | 2020 | Non-Executive | - | 11/15 |
| Noshaq SA (permanent representative: Mr. Gaëtan Servais) |
Director | 2021 | Non-Executive | Risk and Audit Committee | 14/15 |
| Eva Consulting SRL (permanent representative: Mr. Jean-Michel Foidart) |
Director | 2021 | Executive | - | 14/15 |
| P4Management BV (permanent representative: Mrs. Christiane Malcorps) |
Director | 20206 | Independent | Nomination and Remuneration Committee |
10/15 |
| Alychlo NV (permanent representative: Mr. Marc Coucke) |
Director | 20206 | Chair Non-Executive |
- | 8/15 |
| Aubisque BV (permanent representative: Mrs. Freya Loncin) |
Director | 20206 | Non-Executive | - | 9/15 |
| Ahok BV (permanent representative: Mr. Koen Hoffman) |
Director | 2021 | Independent | Risk and Audit Committee | 15/15 |
| P.Suinen SRL (permanent representative: Mr. Philippe Suinen) |
Director | 20206 | Independent | Risk and Audit Committee | 11/15 |
| Castors Development SA (permanent representative: Mr. Jacques Platieau) |
Director | 20206 | Independent | Nomination and Remuneration Committee (Chair) |
11/15 |
| Noshaq Partners SCRL (permanent representative: Mrs. Joanna Tyrekidis) |
Director | 20206 | Non-Executive | - | 11/15 |
| Mrs. Patricia van Dijck | Director | 2021 | Chair ad interim7 Independent |
Nomination and Remuneration Committee |
13/15 |
| Selva Luxembourg SA (permanent representative: Mr. Christian Moretti) |
Director | 2021 | Non-Executive | Nomination and Remuneration Committee (Chair) |
15/15 |
The term of the mandate of the Director will expire immediately after the Annual General Shareholders' Meeting held in the year set forth next to the Director's name. Current Directors were reappointed at the Extraordinary Shareholders Meeting held on 16 May 2019, unless specified otherwise above.
The number of meetings attended by each Director should take into account the expiration of the term of the mandate of certain Directors during the year as well as the nomination of new Directors during the financial year.
More detailed information on the Board of Directors' responsibilities, duties, composition and operation can be found on the Company's website (www.mithra.com) in the Company's articles of association and Corporate Governance Charter.
In 2020, fifteen Board meetings have been held (in case two distinct meetings take place successively, the two meetings have been taken into account hereinabove).
TheBoardmeetingsweremainly relatedtothe financialresultsand financialreporting, includingthe half-yearandfinancial statements and budget, the Company's financing strategy and related capital transaction, and R&D progress, important agreements or (expected) acquisitions and divestments, and continuous evaluation of the structure of the Company.
In addition, the Board of Directors met to resolve on various (conditional) capital increases, the creation of the 2020 Share Option Plan, the grant of additional share options, the renewal of the Board of Directors and the reinforcement of the Executive Management Team.
Under the lead of the Chair and assisted by the Nomination and Remuneration Committee (and possibly also by external experts) the Company's Board of Directors will conduct, every 3 years, a self-evaluation in respect of its size, composition, performance and those of its Committees, as well as in respect of its interaction with the executive management. The evaluation shall have the following objectives:
The Non-Executive Directors shall annually assess their interaction with the Executive Management Team. In this respect, Non-Executive Directors shall meet at least once a year in absence of the CEO and the other executive Directors, if any. No formal Board decision can be taken at such meeting.
There is a periodic evaluation of the contribution of each Director aimed at adapting the composition of the Board of Directors. At the time of their re-election, the Directors' commitments and contributions are evaluated within the Board of Directors, and the Board of Directors ensures that any appointment or re-election allows an appropriate balance of skills, knowledge and experience to be maintained. The same applies at the time of appointment or reelection of the Chairs (of the Board of Directors and of the Board Committees).
The Board shall act on the results of the performance evaluation by recognising its strengths and addressing its weaknesses. Where appropriate, this will involve proposing new members for appointment, proposing not to re-elect existing members or taking any measure deemed appropriate for the effective operation of the Board.
This evaluation took place in fiscal year 2018 and will be renewed in fiscal year 2021. The Board always acts on the results of the performance evaluation by recognizing its strengths and addressing its weaknesses. Where appropriate, this could involve proposing new members for appointment, proposing not to re-elect existing members or taking any measure deemed appropriate for the effective operation of the Board of Directors.
The Board of Directors has set up a Risk and Audit Committee, in line with the Belgian Companies and Associations Code.
More detailed information on the Risk and Audit Committee's responsibilities can be found in the Company's Corporate Governance Charter, which can be found on Mithra'swebsite (www.mithra.com).
The Chair of the Risk and Audit Committee reports to the meeting of the Board of Directors subsequent to each meeting of the Risk and Audit Committee on its activities, conclusions, recommendations and resolutions. On an annual basis, the Chair of the Risk and Audit Committee also reports to the Board of Directors on the Risk and Audit Committee'sperformance.
The Risk and Audit Committee is composed of three (3) members, which are exclusively Non-Executive Directors. The majority of its members are Independent Directors in the meaning of article 7:87 of the Belgian Companies and Associations Code.
At least one of its members has the necessary expertise with regard to accounting and auditing. The Board of Directors ensures that the Risk and Audit Committee has the necessary and sufficient expertise with regards to accounting, audit and finance, in order to fulfil its role in an adequate manner. The Chair of the Risk and Audit Committee is not the Chair of the Board of Directors. The CEO and CFO can attend the meetings of the Risk and Audit Committee in an advisory and non-voting capacity. At least twice a year, the Risk and Audit Committee meets the Statutory Auditor in order to discuss questions regarding its mandate, the audit procedure and, in particular, the potential weaknesses identified in the control.
The following Directors were members of the Risk and Audit Committee until 25 November 2020: Ahok BV (permanent representative: Mr. Koen Hoffman) (Chair), P. Suinen SRL (permanent representative: Mr. Philippe Suinen) and Noshaq SA (permanent representative: Mr. Gaëtan Servais). Ahok BV (permanent representative: Mr. Koen Hoffman) and P. Suinen SRL (permanent representative: Mr. Philippe Suinen) were both IndependentDirectors.
On 25 November 2020, the Board's composition was renewed. 7 Directors resigned and 2 new Directors were appointed. As a consequence, the composition of the Risk and Audit Committee was also changed. For further information on the renewal of the Board's composition, please see the press release published by the Company on 3 November 2020 on its website (https://investors.mithra.com/en/press-releases/).
The following Directors are members of the Risk and Audit Committee since 25 November 2020: Mr. Erik Van Den Eynden, replaced on 22 December 2020 by his management company, TicaConsult BV (permanent representative: Mr. Erik Van Den Eynden) (Chair), Ahok BV (permanent representative: Mr Koen Hoffman) and Noshaq SA (permanent representative: Mr. Gaëtan Servais). TicaConsult BV (permanent represenative: Mr. Erik Van Den Eynden) and Ahok BV (permanent representative: Mr. Koen Hoffman) are both IndependentDirectors.
The Risk and Audit Committee met seven(7) times in 2020. The statutory auditor was present at 2 of these seven meetings.
The main topics discussed were the interim half-year and annual financial information and figures, the budget, the statutory auditor's external audit, internal control, risk management and compliance including the implementation of a Business Code of Conduct, the review of the equity transactions. The opinion of the Risk and Audit Committee has also been specifically requested on transactions where there were conflicts of interest.
Attendance was as follows: Ahok BV (permanent representative: Mr. Koen Hoffman): 7, P.Suinen SRL (permanent representative: Mr. Philippe Suinen): 6/7, Noshaq SA (permanent representative: Mr. Gaëtan Servais): 67, and TicaConsult BV (permanent represenative: Mr. Erik Van Den Eynden): 1/7. The number of meetings attended by each Director should take into account the expiration of the term of the mandate of certain Directors during the year as well as the nomination of new Directors during the financial year.
The Board of Directors has set up a Remuneration Committee, in line with the Belgian Companies and Associations Code.As the RemunerationCommittee also performs the task of a Nomination Committee, it is called the Nomination and Remuneration Committee.
More detailed information on the Nomination and Remuneration Committee's responsibilities can be found in the Company's Corporate Governance Charter, which can be found on Mithra'swebsite (www.mithra.com). In principle, the Nomination and Remuneration Committee will meet at least two (2) times per year.
The Nomination and Remuneration Committee is composed of three members, which are exclusively Non-Executive Directors. The majority of its members are Independent Directors in the meaning of article 7:87 of the Belgian Companies and Associations Code.
The Nomination and Remuneration Committee has the necessary expertise in terms of the remuneration policy, which is evidenced by the experience and previous roles of its members.
The following Directors were members of the Nomination and Remuneration Committee until 25 November 2020: Castors Development SA (permanent representative Mr. Jacques Platieau), P4Management BV (permanent representative: Mrs. Christiane Malcorps) and Noshaq SA (permanent representative : Mr. Gaëtan Servais). P4Management (permanent representative: Mrs Christiane Malcorps) and Castors Development SA (permanent representative Mr Jacques Platieau) were both Independent Directors.
On 25 November 2020, the Board's composition was renewed. 7 Directors resigned and 2 new Directors were appointed. As a consequence, the composition of the Nomination and Remuneration Committeewas also changed. For further information on the renewal of the Board's composition, please see the press release published by the Company on 3 November 2020 on its website (https://investors.mithra.com/en/press-releases/).
The following Directors are members of the Nomination and Remuneration Committee since 25 November 2020: Selva Luxembourg SA (permanent representative: Mr. Christian Moretti) (Chair), Mrs. Patricia van Dijck and Sunathim BV (permanent representative: Mr. Ajit Shetty). Mrs. Patricia van Dijck and Sunathim BV (permanent representative: Mr. Ajit Shetty) are both Independent Directors.
The CEO is invited to attend the meetings of the Nomination and Remuneration Committee in an advisory and non-voting capacity. He does not attend discussions concerning his own remuneration.
TheChair ofthe Nomination &RemunerationCommittee reports to the Board subsequentto eachCommittee meeting on its activities, conclusions, recommendations and resolutions. The Chair of the Nomination & Remuneration Committee shall, on an annual basis, report to the Board on the Nomination & Remuneration Committee's performance. Every three (3) years, the Nomination & Remuneration Committee reviews its terms of reference and its own effectiveness and recommends any necessary changes to the Board.
The Nomination & Remuneration Committee met five (5) times in2020.
The main topics discussed were the preparation of the remuneration report, the performance of the CEO and other members of the Executive Management Team, their appointment, resignation, and remuneration (including the grant of subscription rights), the composition of the Executive Management Team, the assessment of the contractual conditions giving right to bonuses to the CEO, the implementation of a new Corporate Governance Charter and the renewal of the Board of Directors.
Attendance was as follows: Castors Development SA (permanent representative: Mr. Jacques Platieau): 4/5, P4Management BV (permanent representative: Mrs. Christiane Malcorps): 4/5, Noshaq SA (permanent representative Mr. Gaëtan Servais): 4/5, Selva Luxembourg SA (permanent representative: Mr. Christian Moretti): 1/5, Mrs. Patricia van Dijck: 1/5, and Sunathim BV (permanent representative: Mr. Ajit Shetty): 1/5.The number of meetings attended by each Director should take into account the expiration of the term of the mandate of certain Directors during the year as well as the nomination of new Directors during the financial year.
By a decision of 15 June 2015, the Board of Directors of the Company set up an Executive Management Team. The Executive Management Team is an advisory committee to the Board of Directors.
The Executive Management Team's mission is to discuss and consult with the Board and advise the Board on the day-to-day management of the Company in accordance with the Company's values, strategy, general policy and budget, as determined by the Board.
While exercising its advisory responsibilities, the Executive Management Team shall be guided by the interests of the Company and its business.
More detailed information on the Executive Management Team's responsibilities can be found in the Company's Corporate Governance Charter, which can be found on Mithra'swebsite. (www.mithra.com).
The Executive Management Team is currently composed of 9 members: the Chief Executive Officer ad Interim (CEO ad Interim)1 , the Chief Executive Officer (CEO) under leave of absence2 , Chief Business Development Officer (CBDO), under leave of absence2 , The Chief Financial Officer (CFO), Public Relations Officer (PRO), Chief Scientific Officer (CSO), the Investor Relations Officer (IRO), the Chief Supply Chain Officer (CSCO), the Plant Manager, and the President of the Scientific Advisory Board. The Executive Management Team is chaired by the CEO (ad interim)1,2 of the Company. Furthermore, the Chair may invite additional personnel to attend a meeting of the Executive Management Team.
The members of the Executive Committee as of the date of this report are listed in the table below.
| Name | Function |
|---|---|
| Van Rompay Management BV (permanent representative: 1 Mr. Leon Van Rompay) |
Chief Executive Officer ad Interim (CEO ad Interim) |
| Yima SRL (permanent representative: Mr. François Fornieri)2 | Chief Executive Officer under leave of absence, Chief Business Development Officer under leave of absence |
| Eva Consulting SRL (permanent representative: Mr. Jean-Michel Foidart) |
Chair of the Scientific Advisory Board |
| CMM&C SRL (permanent representative: Mr. Christophe Maréchal) | Chief Financial Officer (CFO) |
| BGL Consulting SRL (permanent representative: Mr. Benjamin Brands) |
Chief Supply Chain Officer (CCO) |
| Novafontis SRL (permanent representative: Mr. Jean-Manuel Fontaine) |
Public Relations Officer (PRO) |
| GD Lifescience SRL (permanent representative: Mr Graham Dixon) | Chief Scientific Officer (CSO) |
| Mr. Benoît Mathieu5 | Investor Relations Officer (IRO) |
| MAREBA BVBA (permanent representative: Mr Renaat Baes) 6 | Plant Manager |
In 2020, The Executive Management Teammetregularly and atleast once every month.The CEOreported and advised the Board on the day-to-day management at every meeting.
Article 7:86 of the Belgian Companies and Associations Code provides that at least one third of the members of the Board of Directors should be of the opposite gender. In order to calculate the required number of Directors of a different gender, fractions must be rounded to the nearest whole number. These gender diversity requirements are applicable to the composition of the Board of Directors of companies, the securities of which are listed, for the first time as from the first day of the sixth year following the date they became publicly listed. If, for any reason whatsoever, the composition of the Board of Directors does not or no longer meets the conditions laid down here above, the first General Shareholders' Meeting that follows shall constitute a Board of Directors that meets these requirements.
Since the Annual General Shareholders' Meeting of 16 May 2019, the Company complied with the gender diversity requirements set by article 7:86 of the Belgian Companies and Associations Code. However, on 3 November 2020, the Company announced that, in accordance with its strategic operating plan and in order to support and accelerate its development, it decided to start a renewal process of its Board of Directors. On 25 November 2020, 7 Directors resigned and 2 new Directors were co-opted by the Board of Directors until the next Annual General Shareholders' Meeting that will be held in 2021 and will resolve upon the approval of the financial statements for the fiscal year ended on 31 December 2020. In consequence, the Board of Director is now composed of 8 Directors, 7 of which are men and 1 is a woman.
In accordance with article 7:86 of the Belgian Companies and Associations Code, the board of Directors will propose to appoint 2 new female Directors to the next Annual General Shareholders' Meeting that will be held in 2021 and will resolve upon the approval of the financial statements for the fiscal year ended on 31 December 2020. Should this proposition be approved by the shareholders, the Board of Directors will be composed of 3 female and 7 male Directors (representing a ratio of 30.00% female Directors against 70.00% male Directors).
In the future, the Company undertakes to strive to maintain a well-balanced general diversity at the Board of Directors.
The Company operates a risk management and control framework in accordance with the Belgian Companies and Associations Code and the 2020 Code. The Group is exposed to a wide variety of risks within the context of its business operations that can result in its objectives being affected or not achieved. Controlling those risks is a core task of the Board of Directors (including the Risk and Audit Committee), the Executive Management Team and all other employees with managerial responsibilities.
The Executive Management Team leads the Company within the framework of prudent and effective control, which enables it to assess and manage risks. The Executive Management Team develops, maintains and ongoingly improves (including with the support of external advisers) adequate internal control and risk management procedures so as to offer a reasonable assurance concerning the realization of goals, the reliability of the financial information, the observance of applicable laws and regulations and to enable the execution of internal control and risk management procedures.
The Executive Management Team is an advisory committee to the Board of Directors and the CEO on the day-to-day management of the Company. Each member of the Executive Management Team has individually been made responsible for certain aspects of the day-to-day management of the Company and its business (in case of the CEO, by way of a delegation from the Board of Directors; in case of the other Executive Management Team members, by way of an informal delegation from the CEO). In the case that any decision to be taken by a member of the Executive Management Team could be material to the Company, it shall be presented and discussed at a meeting of the Executive Management Team. The Executive Management Team meets several times per month.
During those Executive Management Team meetings, there is a follow-up on the progress of various Group projects, clinical studies, business development deals, and other material matters.
The process of gathering financial information is organized on quarterly, half-year and annual basis, and report of such information is made to the CEO and to the Risk and Audit Committee. A central team produces the accounting figures under the supervision of the CFO and Group controller and the books are kept by an ERP (Dynamics AX). The cash and working capital are monitored on a continuous basis migrated to D365 version early 2021
The quality of the internal control and risk management is assessed during the course of the financial year and on an ad hoc basis with internal audits (supply chain, IT, PO validation workflows, working capital management, etc.) carried out on the basis of potential risks identified. The conclusions are shared and validated with the Risk and Audit Committee. During the financial year, the Risk and Audit Committee undertakes reviews of the half-year closures and specific accounting treatments. It reviews the disputes and puts all the questions it deems relevant to the Auditor and to the CFO or to the Executive Management Team of the Company.
Post period, the Company has mandated PWC in order to audit the Company's current governance policies with the view of assisting the Company to set up optimized governance policies more suited for a fully fledged commercial Company.
The Risk and Audit Committee assists the Board of Directors in the execution of its task to control the Executive Management Team.
The Executive Management Team has organized the internal control environment, which is monitored by the Risk and Audit Committee. The Risk and Audit Committee decided not to create an internal audit role, since the scope of the business does not justify a full-time role.
The role of the Risk and Audit Committee is to assist the Board of Directors in fulfilling its monitoring responsibilities, as stipulated in the Company's Corporate Governance Charter and the Business Code of Conduct. These responsibilities include the financial reporting process, internal control and risk management systems (including the Company's process for monitoring compliance with laws and regulations) and the external audit process.
With a view to preventing market abuse (insider dealing and market manipulation), the Board of Directors has established a dealing code. The dealing code describes the declaration and conduct obligations of Directors, executives and workers of the Group with respect to transactions in shares and other financial instruments of the Company. The dealing code sets limits on carrying out transactions in shares and other financial instruments of the Company, and allows dealing by the above mentioned persons only during certain windows.
BDO Réviseurs d'Entreprises SCRL, with registered office at Rue de Waucomont 51, , 4651 Herve, Belgium, member of the Institut des Réviseurs d'Entreprises/Instituut der Bedrijfsrevisoren, represented by Cédric Antonelli, auditor, has been renewed as Statutory Auditor of the Company on 17 May 2018 for a term of three years ending immediately after the Shareholders Meeting to be held in 2021 which will deliberate and resolve on the financial statements for the financial year ended on 31 December 2020. BDO Réviseurs d'Entreprises SCRL is a member of the Belgian Institute of Certified Auditors ("Institut des Réviseurs d'Entreprises") (membership number B00023).
The Statutory Auditor and the auditor responsible for the audit of the consolidated financial statements, confirms annually in writing to the Risk and Audit Committee his or her independence from the Company, discloses annually to the Risk and Audit Committee any additional services provided to the Company, and discusses with the Risk and Audit Committee the threats to his or her independence and the safeguards applied to mitigate those threats as documented by him or her.
During the past fiscal year, in addition to its usual activity, the Statutory Auditor performed additional activities on behalf of the Company mainly for the issuance of special reports, for participation to meeting of the Risk and Audit Committee and for participation to special projects.
In 2020, the Company spent EUR 254,257 for fees related to the activities of the auditor, split as follows:
| In Euro (€) | |
|---|---|
| Auditor's fees | 159,434 |
| Fees for exceptional services or special missions (audit related) | 50,808 |
| Tax consultancy (audit related) | - |
| Fees for exceptional services or special missions (external to audit) | - |
| Tax consultancy (external to audit) | 44,015 |
| Total | 254,257 |
No takeover bid has been instigated by third parties in respect of the Company's equity during the current financial year.
The Company provides the following information in accordance with Article 34 of the Belgian Royal Decree dated 14 November 2007:
The share capital of the Company amounts to EUR 31,270,872.40 and is fully paid-up. It is represented by 42,714,097 ordinary shares, each representing a fractional value of (rounded) EUR 0.7321 and representing one 42,714,097th of the share capital. The Company's shares do not have a nominal value.
Other than the applicable Belgian legislation on the disclosure of significant shareholdings and the Company's articles of association, there are no restrictions on the transfer of shares.
There are no holders of any shares with special control rights.
There are no share option plans for the personnel other than the share option plans disclosed elsewhere in this report. These share option plans contain provisions on accelerated vesting in case of change of control.
Each shareholder of the Company is entitled to one vote per share. Voting rights may be suspended as provided in the Company's articles of association and the applicable laws and articles.
There are no agreements between shareholders which are known by the Company that may result in restrictions on the transfer of securities and/or the exercise of voting rights.
The rules governing appointment and replacement of board members and amendment to articles of association are set out in the current versions of the Company's articles of association and the Company's Corporate Governance Charter.
The powers of the Board of Directors, more specifically with regard to the power to issue or redeem shares are set out in the Company's articles of association. The Board of Directors was not granted the authorization to purchase its own shares "to avoid imminent and serious danger to the Company" (i.e., to defend against public takeover bids). The Board of Directors is however authorised to dispose of listed shares or certificates, in accordance with article 7:218 of the Belgian Companies and Associations Code (this authorisation extends to disposals made by its direct subsidiaries, as defined in article 3:22 of the Belgian Companies and Associations Code).
At the date of this report, the Company is a party to the following significant agreements which, upon a change of control of the Company or following a takeover bid can enter into force or, subject to certain conditions, as the case may be, can be amended, be terminated by the other parties thereto or give the other parties thereto (or beneficial holders with respect to bonds) a right to an accelerated repayment of outstanding debt obligations of the Company under such agreements:
and fully payable early in case of Change of Control within the meaning of the aforementioned provision within the Company.
At the date of this report, there is no agreement between the Company and the members of its Board or its personnel, which provide for indemnities if the Board members resign or have to cease their functions without a valid reason or if the employment of the members of the personnel is terminated due to a public takeover bid.
As prescribed by provision 3:6, §3 of the CCA, please find below the remuneration report pursuant to financial year 2020 prepared by the Nomination and Remuneration Committee. It will be submitted to the General Meeting of Shareholders.
The Remuneration and Nomination Committee confirms that, for the duration of the financial year 2020, the members of the Board of Directors and the executive Committee, were subject to a remuneration policy compliant with the Corporate Governance Charter which has been amended in April 2020 to reflect the new provisions of the CCA as well as the Code of Corporate Governance 2020 (CBGE 2020).Post period, the Board of Directors upon recommendation of the Nomination and Remuneration Committee prepared a remuneration policy in accordance with provision 7:89 of the CCA which will be subject to the General Meeting of 22 May 2021's approval. .
The Directors as well as the members of the Executive Management Team are paid by Mithra Pharmaceuticals SA, parent company of the Mithra Group even though, members can perform tasks for the subsidiaries of the Group.
In 2020 still, the Nomination and Remuneration Committee recommended the level of remuneration for Directors, including the Chairman of the Board, which is subject to approval by the Board of Directors and, subsequently, by the Annual Shareholders Meeting.
The Nomination and Remuneration Committee benchmarks the Directors' compensation against peer companies. The level of remuneration should be sufficient to attract, retain and motivate Directors who match the profile determined by the Board.
Apart from their remuneration, all Directors will be entitled to a reimbursement of out-of-pocket expenses actually incurred as a result of their participation in meetings of the Board of Directors.
The level of remuneration of the Directors was determined at the occasion of the Company's Initial Public Offering on 8 June 2015 and explained in the Prospectus issued by the Company in that context. The Company's policy with respect to the remuneration of its Directors has been further detailed in its 2020 Corporate Governance Charter. Those principles have been used by the Board of Directors, upon recommendation of the Nomination and Remuneration Committee, to draft a remuneration policy proposal to be submitted to the General Meeting which shall gather on 20th May 2021. . The remuneration of the Directors will be disclosed to the Company's shareholders in accordance with the applicable laws and regulations.
The Directors' mandate may be terminated ad nutum (at any time) without any form of compensation. There are no employment or service agreements that provide for notice periods or indemnities between the Company and the members of the Board of Directors, who are not a member of the Executive Management Team. These informations are further detailed in the draft remuneration policy which is submitted for approval to the General Meeting.
The remuneration package for the Non-Executive Directors (whether or not independent) approved by the Shareholders Meeting of 8 June 2015 is made up of a fixed annual fee of EUR 20,000. The fee is supplemented with a fixed annual fee of EUR 5,000 for membership of each committee of the Board of Directors, and an additional fixed annual fee of EUR 20,000 for the Chairman of the Board. Changes to these fees will be submitted to the Shareholders Meeting for approval.
There is no performance-related remuneration for Non-Executive Directors. Therefore, the percentage for those nonexecutive Directors is 100% of fix remuneration.
Apart from the above remuneration for Non-Executive Directors (whether or not independent), all Directors will be entitled to a reimbursement of out-of-pocket expenses incurred as a result of participation in meetings of the Board of Directors.
The total amount of the remuneration and the benefits paid in 2020 to the Non-Executive Directors (in such capacity) was EUR 258,107(gross, excluding VAT), split as follows:
| Name | Nature | Remunerations | As member of a committee |
As chairman of the board |
|---|---|---|---|---|
| CG Cube SA | Non-exec | 18,044 | ||
| NOSHAQ SA | Non-exec | 20,000 | 10,000 | |
| Alychlo NV | Non-exec - Chair | 16,667 | 16,667 | |
| P. Suinen SRL | Independent | 18,332 | 3,125 | |
| Castors Development SA2 | Independent | 20,000 | 5,000 | |
| Ahok BVBA | Independent | 20,000 | 5,000 | |
| Aubisque BV | Non-exec | 18,333 | ||
| P4Management BVBA | Non-exec | 20,000 | 2,917 | |
| NOSHAQ Partner SCRL | Non-exec | 19,021 | ||
| P. van Dijck | Non-exec | 20,000 | 5,000 | |
| Selva Luxembourg SA | Non-exec | 20,000 | ||
| Sunathim BV | Non-exec | O | O | |
| TicaConsult BV | Non-exc | 0 | 0 |
Alychlo NV, Aubisque BVBA, CG Cube S.A., P4Management BV, P.Suinen SRL, Castors Development SA and Noshaq Partners SCRL resigned from all their mandates within the Company with effect as from the 25 November 2020. CG Cube SA, Alychlo NV, P-Suinen SRL, Aubisque BVBA, P4 Management BVBA and NOSHAQ Partners SCRL invoiced the Company pro rata temporis for Q4 2020.
As a result, the Board of Directors coopted the following directors to fill in the vacancy seats pursuant to provision 7:88 §1 of the BCAC on the 25th November 2020:
Sunathim BV (represented by Mr. Ajit Shetty) was co-opted by the Board of Directors as Independent Director, until the next General Shareholders' Meeting;and was appointed as member of the Nomination and Remuneration Committee on the 25th November 2020.
Mr. Erik Van Den Eynden was co-opted by the Board of Directors as Independent Director, until the next General Shareholders' Meeting. On 22 December 2020, at the request of Mr. Erik Van Den Eynden, the Board of Directors agreed to replace him by TicaConsult BV (represented by Mr. Erik Van Den Eynden; TicaConsult BV was appointed as chair of the Risk and Audit Committee on the 25th November 2020.
None of those two directors invoiced the Company for the conduct of their 2020 mandate.
The table below provides an overview of the shares and warrants held by the current members of the Board on the 31st of December 2020.
| Share- Warrantholder | Shares | % | Warrants* | % | Shares and Warrants |
% |
|---|---|---|---|---|---|---|
| YIMA SRL (permanent representative: Mr François Fornieri) (CEO) |
0.00 | 0 | 952,790 | 25.08 | 952,790 | 2.05 |
| Mr François Fornieri (permanent representative of YIMA SRL) |
11,159,755 | 26.13 | 1,173,000 | 30.88 | 12,332,755 | 26.51 |
| Marc Beyens | 0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| CG CUBE S.A. (permanent representative: Guy Debruyne) |
0 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Guy Debruyne (permanent representative of CG Cube S.A.) (together with CG Cube S.A.) |
65,800 | 0.15 | 0 | 0,00 | 65,800 | 0.14 |
| AHOK BVBA (permanent representative : Mr Koen Hoffman) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Koen Hoffman (permanent representative of Ahok BVBA) (together with Ahok BVBA) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| NOSHAQ SA (permanent representative: Gaëtan Servais) |
5,076,390 | 11.88 | 75,000 | 1.97 | 5,151,390 | 11.08 |
| Gaëtan Servais (permanent representative of NOSHAQ SA) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Aubisque BVBA (permanent representative : Ms Freya Loncin) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Freya Loncin (permanent representative of Aubisque BVBA) (together with Aubisque BVBA) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Marc Coucke (permanent representative of Alychlo NV) (Marc Coucke together with Alychlo NV and Mylecke Management, Art & Invest NV) |
6,464,730 | 15.13 | 75,000 | 1,97 | 6,539,730 | 14.06 |
| Eva Consulting SRL (permanent representative : Jean-Michel Foidart) |
0.00 | 0.00 | 52,695 | 1.39 | 52,695 | 0.11 |
| Mr Jean-Michel Foidart (permanent representative of Eva Consulting SRL) (together with Eva Consulting SRL) |
41,460 | 0.10 | 0 | 0.00 | 41,460 | 0.09 |
| P4MANAGEMENT SRL (permanent representative Christiane Malcorps) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Christiane Malcorps (permanent representative of |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| P4MANAGEMENT SA, together with P4MANAGEMENT SRL) |
||||||
|---|---|---|---|---|---|---|
| P.SUINEN SRL-S (permanent representative:Mr Philippe Suinen) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Philippe Suinen (permanent representative of P.SUINEN SRL-S, together with P.SUINEN SRL-S) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| CASTORS DEVELOPMENT SA (permanent representative Mr Jacques Platieau) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Mr Jacques Platieau (permanent representative of Castors Development SA, together with Castors Development SA) |
1,600 | 0.00 | 0 | 0.00 | 1,600 | 0.00 |
| NOSHAQ Partner SCRL (permanent representative Mrs Joanna Tyrekidis) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Mrs Joanna Tyrekidis (permanent representative of Noshaq Partner SCRL) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Mrs Patricia Van Dijck | 0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Selva Luxembourg SA (permanent representative M. Christian Moretti) |
689,655 | 1.61 | 0 | 0.00 | 689,655 | 1.48 |
| Christian Moretti (permanent representative of de Selva Luxembourg SA) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Sunathim BV (permanent representative Ajit Shetty) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Mr Ajit Shetty (permanent representative of Sunathim BV |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| TicaConsult BV (permanent representative Mr Erik Van Den Eynden) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Mr Erik Van Den Eynden (permanent representative of TicaConsult BV) |
0.00 | 0.00 | 0 | 0.00 | 0 | 0.00 |
| Subtotal | 23,499,390 | 55.02 | 2,328,485 | 61.30 | 25,827,875 | 55.53 |
* corresponds to the amount of shares following warrant conversion.
During the fiscal year 2020, the Executive -Directors perceived part of their remuneration as a fix amount and part of their remuneration by means of warrants. No variable remuneration were paid.
The remuneration of the members of the Executive Management Team is determined by the Board of Directors upon recommendation of the Nomination and Remuneration Committee and subsequent to the CEO's recommendation to this Committee (except for his own remuneration). the Company strives to be competitive in the European market.
The level and structure of the remuneration of the members of the Executive Management Team is such that qualified and expert professionals can be recruited, retained and motivated taking into account the nature and scope of their individual responsibilities.
The remuneration of the members of the Executive Management Team currently consists of the following elements:
The Company's policy with respect to the remuneration of its Executive Management team has been further detailed in its 2020 Corporate Governance Charter. Those principles have been used by the Board of Directors, upon recommendation of the Nomination and Remuneration Committee, to draft a remuneration policy proposal to be submitted to the General Meeting which shall gather on 20th May 2021
In addition to the 2015 Warrant Plan, in order to include new members of the Executive Management team, a short and long term performance based remuneration and incentive scheme has been elaborated within the Nomination and Remuneration Committee, validated by the Board of Directors and formally approved by the Extraordinary General Meeting of shareholders on 5 November 2018. Such scheme is based on objectives which are, in accordance with Article 520bis of the BCC (article 7:90 of the CCA), pre-determined by an explicit decision of the Board of Directors and were chosen so as to link rewards to corporate and individual performance, thereby aligning on an annual basis the interests of all members of the Executive Management Team with the interests of the Company and its shareholders and benchmarked with the practices in the sector.
Following the implementation of the new BCCA, the Board of Directors decided to issue a new warrant plan (Warrant Plan 2020) within the framework of the authorized capital for members of its personnel. The purpose of the Warrant Plan 2020 is to create a share option plan for the members of the personnel in accordance with the provisions of the BCCA. The number of share options issued under this plan, 390,717 warrants is the same as the number of share options which have not yet been granted under the Warrant Plan 2018 which was created in November 2018 in accordance with the provisions of the (old) Belgian Companies Code of 7 May 1999. Therefore, the Board of directors also decided to no longer grant an equal number of outstanding share options under the Warrant Plan 2018 that have not yet been granted to the selected participants of the Warrant Plan 2018. This Warrant Plan 2020 has a longevity period of 10 years and is not subject to vesting conditions.
The amount of remunerations and benefits paid in 2020 to the CEO and the other members of the Executive Management Team, (gross, excluding VAT) is shown in the table below:
| Thousands of Euro (€) | Total | Of which CEO |
|---|---|---|
| Basic Remuneration | 2,532 | 919 |
| Variable Remuneration | - | - |
| Group Insurance (pension, invalidity, life) | 2 | - |
| Other insurance (car, cell phone, hospitalization) | 5 | - |
| Total | 2,538 | 919 |
Only the member of the Executive Management Team which performed his services through an employment contract had a Group Insurance scheme which covered pension benefits throughout the year 2020 The Group insurance amounted to 4% of this yearly gross remuneration (3% in charge of the Company and 1% in his own charge) and was cashable when the employee would reach 65 years old. In case the employee would leave the Company, he would keep the collected amounts and the Group insurance would cease to his profit.
The table below provides an overview of the shares and warrants held by the members of the Executive Management Team, including the Executive Director on 31 December 2020 (i.e. the CEO). The share-based payment costs related to warrants held by the members of the Executive Management Team represent EUR 6,535k (including EUR 4,054k for the CEO), out of the total share-based payment costs of EUR 7,267k included in the net loss for the period.
| Share- / Warrantholder | Shares | % | Warrants | % | Shares and Warrants |
% |
|---|---|---|---|---|---|---|
| YIMA SRL (permanentrepresentative: Mr. François Fornieri) (CEO) |
0 | 0.00% | 952,790 | 25.08% | 952,790 | 2.00% |
| Mr. François Fornieri (permanent representative of YIMA SRL) |
11,159,755 | 26.00% | 1,173,000 | 30.88% | 12,332,755 | 27.00% |
| Mr. Christophe Maréchal (representative of and together with CMM&C SRLBVBA) |
0 | 0.00% | 235,502 | 6.20% | 235,502 | 1% |
| Mr. Jean-Michel Foidart (representative of and together with Eva Consulting SRL) |
41,460 | 0.01% | 52,695 | 1.39% | 94,155 | 0.% |
| Mr. Benjamin Brands (representative of and together with BGL Consulting SRL) |
0 | 0.00% | 67,695 | 1.78% | 67,695 | 0.% |
| Mr. Jean-Manuel Fontaine (representative of and together with Novafontis SA) |
28 | 0.00% | 52,695 | 1.39% | 52,723 | 0.% |
| M. Renaet Baes (representative of and together with 1 Mareba BVBA) |
0 | 0,00 % | 35,000 | 0,92 % | 35,000 | 0 % |
| Mrs. Alexandra Deschner (representative of and together with Viribus Valorem SRL) |
0 | 0 | 30,000 | 0,79% | 30000 | 0 |
| Mr. Patrick Kellens | 0 | 0.00% | 0 | 0.00% | 0 | 0% |
| Mr. Graham Dixon (representative of and together with GD Lifescience SRL |
0 | 0.00% | 25,000 | 0.66% | 25,000 | 0% |
| Subtotal | 11,201,243 | 26% | 2,624,377 | 69.09% | 13,825,620 | 29.72% |
| Total | 42,714,097 | 100.00% | 3,798,617 | 100.00% | 46,512,714 | 100.00% |
On 3 February 2021, the Board of Directors decided to appoint Van Rompay Management BV (represented by Mr. Leon Van Rompay) as CEO ad Interim until further notice. For further information, please see the press release published by the Company on 4 February 2021 on its website (https://investors.mithra.com/en/press-releases/).
On 3 February 2021, the Board of Directors accepted that Yima SRL (represented by Mr. François Fornieri) take a step back as CEO, until further notice, for a maximum of 12 months. Consequently, for the time being, François Fornieri (through Yima SRL or in any other way) does not exercise any executive function within the Mithra Group. For further information, please see the press release published by the Company on 4 February 2021 on its website (https://investors.mithra.com/en/press-releases/).
On 22 December 2020, the Board of Directors decided upon recommendation of the Nomination and Remuneration Committee to appoint IARA SRL (Mrs Jessica Salmon), Corporate Controlling Officer and Executive Deputy, as member of the Executive Committee. IARA SRL left the company with effect as from 23rd March 2021.
The Company has put into place five warrants plans since its incorporation, three of which are performance related for the Executive Management Team amongst others.
First, the Extraordinary Shareholders Meeting of the Company of 2 March 2015 approved, upon proposal of the Board of Directors, the issuance of warrants giving right to subscribe for 1,796,850 shares, which, on a fully-diluted basis, represented 5.56% additional Shares at the time.
These warrants (1089) have been granted free of charge. All warrants have been accepted by the relevant beneficiaries. Each warrant entitled its holder to subscribe for 1,650 Shares of the Company at a subscription price of EUR 5,646.00 per 1,650 Shares (a part corresponding to the par value of the existing Shares on the day the warrants are exercised will be allocated to the share capital). The balance will be booked as an issue premium.
These warrants can be exercised as from 1 January 2019, and have a term of 8 years as from the date of grant. Upon expiration of the term, they become null and void.
As part of that plan, on 30th of January 2019, an increase of capital took place following the exercise of 15 warrants pursuant the 2015 Warrant Plan ("2015 Warrant Plan") corresponding to a contribution of EUR 84,690. In accordance with the 2015 Warrant Plan, the exercise period started on January 1, 2019. An amount of EUR 18,119.48 was therefore contributed in cash to the share capital of Mithra and the balance of EUR 66,570.52 was allocated to the Company's "share premium" account. This exercise of 15 warrants led to the issue of 24,750 shares (1 warrant being equivalent to 1,650 shares) which on February 15th 2019 were admitted to trading on the regulated market. As a result, Mithra's share capital on January 30, 2019 amounted to EUR 27,573,880.18 corresponding to 37,664,245 ordinary shares.
A second increase took place on 24 April 2019, following the exercise of 15 warrants pursuant the 2015 Warrant Plan ("2015 Warrant Plan") corresponding to a contribution of EUR 84,690. An amount of EUR 18,119.40 was therefore contributed in cash to the share capital of Mithra and the balance of EUR 66,570.52 was allocated to the Company's "share premium" account. This exercise of 15 warrants resulted in the issue of 24,750 shares (1 warrant being equivalent to 1,650 shares) which, on May 9, 2019, were admitted to listing on the regulated market. As a result, Mithra's share capital at 24 April 2019 amounted to EUR 27,591,999.58 corresponding to 37,688,995 fully paid-up ordinary shares. The shares have no par value, but represent the same fraction of the Company's share capital, which is denominated in euros. Each share entitles its holder to one voting right. The number of voting rights held by the shareholders was 37,688,995 at 30 June 2019.
On 31 December 2020, 620 warrants of the initial 1089 remained outstanding.
Secondly, on 5 November 2018, Mithra's Extraordinary General Meeting approved the issuance of a maximum of 1,881,974 warrants under the Warrant Plan 2018, for the benefit of key employees, members of the management team and certain Directors. The warrants are expiring five years (maximum holding period) after the date of issuance. They are generally not transferable and in principle, cannot be exercised prior to the date of the grant's second anniversary (i.e. as from 6 November 2020 subject to exercise conditions). The warrants are subject to vesting conditions which have all been met in 2019. Each warrant gives the right to subscribe to one new Mithra share. Should the warrants be exercised, Mithra will apply for the listing of the resulting new shares on Euronext Brussels. The warrants as such will not be listed on any stock exchange market.
Out of the maximum of 1,881,974 warrants which have been issued, a number of 1,394,000have been offered and accepted by beneficiaries until the period under review.
Following the implementation of the new BCCA, the Board of Directors decided to issue a new warrant plan (Warrant Plan 2020) within the framework of the authorized capital for members of its personnel. The purpose of the Warrant Plan 2020 is to create a share option plan for the members of the personnel in accordance with the provisions of the BCCA. The number of share options issued under this plan, 390,717 warrants, is the same as the number of share options which have not yet been granted under the Warrant Plan 2018 which was created in November 2018 in accordance with the provisions of the (old) Belgian Companies Code of 7 May 1999. Therefore, the Board of directors also decided to no longer grant an equal number of outstanding share options under the Warrant Plan 2018 that have not yet been granted to the selected participants of the Warrant Plan 2018. The Warrant Plan 2020 has a longevity period of 10 years and is not subject to vesting conditions.
Therefore, in sum accordance with the Warrant Plan 2015, a remaining number of 620 warrants representing 1,023,000 new shares can still be exercised since 1 January 2019. Additionally, a number of 1,394,400 of new warrants (representing 1,394,900 new shares) shall in principle be exercisable, as from 6 November 2020 subject to exercise conditions pursuant to the Warrant Plan 2018. The amount of 390,717 warrants issued as per the Warrant Plan 2020, representing 390,717 new shares are immediately exercisable upon grant. Up to date an amount of 316,000 warrants has been granted per this 2020 Warrant Plan
In 2020, eight members of the Executive Management Team were recruted based on a service agreement, whereas one member of the Executive Management Team has been engaged based on an employment agreement. Both sorts of contracts can be terminated at any time, subject to certain pre-agreed notice periods, which may, at the discretion of the Company, be replaced by a corresponding compensatory payment.
The service agreement with the CEO, YIMA SRL, sets out a notice period (or notice indemnity in lieu of notice period) of 12 months.
The members of the Executive Management Team perceive part of their remuneration as a fix amount and part of their remuneration in the form of warrants. During the fiscal year 2020.,
The grant of warrants to members of the Executive Management Team has been duly justified in all the issued warrant plan and is performance related driven in order to keep the Executive Management Team interested in the long-term performance of the Company. The purpose is to attract high qualified profiles to help the Company achieve its goals.
In the last five years, the performance of the Company scaled up as the Company progressively signed license and supply agreements as the clinical studies for its product portfolio were moving forward. Notably the Company has performed significantly well in 2018 and 2019 signing several landmark deals and cashing in important milestones payments. In 2020, the Company did not sign any significant deals reducing its EBIT.
In the last five years, the gross remuneration of the Company's employees has increased from 6% (from an average of EUR 49,500, to EUR 52,500). This light increase in the remuneration can be explained by the inflation of the salaries over that period of time.
For further explanations with respect to the personnel benefit on a consolidated basis, please refer to section 9.21.
During fiscal year 2020, the lowest remuneration of the Company's employee amounted to a yearly gross amount of EUR 27,034.45, whereas the highest remuneration granted at management level goes to the CEO, with a yearly gross amount of EUR 918,009.
There are no provisions allowing the Company to reclaim any variable remuneration paid to Executive Management based on incorrect financial information. This point is currently under revision with the draft remuneration policy proposal which is subject to the General Meeting's approval.
In general, the company has no intention to compensate in a subjective or discretionary manner.
By virtue of the resolution of the extraordinary general shareholders' meeting of the Company held on 29 November 2019, as published by excerpt in the Annexes to the Belgian Official Gazette of 30 December 2019 under number 19168869, the Board of directors of the Company has been granted certain powers to increase the Company's share capital in the framework of the authorised capital. The powers under the authorised capital have been set out in Article 7 of the Company's Articles of Association.
In the framework of this authorisation granted by the extraordinary general shareholders' meeting, the board of directors has been authorised to increase, in one or more transactions, the share capital of the Company within the limits provided by law, in particular by issuing convertible bonds and subscription rights, with a maximum amount of EUR 17,597,657.00 (excluding issue premium, as the case may be). The Board of directors is specifically authorised to use this authorisation for the following transactions:
The capital increases that can be effected according to the aforementioned authorisation may take any form whatsoever, in particular contributions in cash or in kind, with or without issue premium, and also by incorporation of reserves and/or issue premiums and/or profits carried forward, to the extent permitted by law.
The aforementioned authorisation is valid for a period of three (3) years as of the date of the publication of the relevant resolution of the extraordinary general shareholders' meeting in the Annexes to the Belgian Official Gazette, i.e., starting on 30 December 2019 and until 30 December 2022.
So far, the board of directors has used its powers under the (renewed) authorised capital:
Neither Mithra Pharmaceuticals SA nor any direct affiliate or any nominee acting in his own name but on behalf of the Company or of any direct affiliate, have acquired any of the Company's shares. Mithra Pharmaceuticals SA has not issued profit-sharing certificates or any other certificates.
The Group uses derivative financial instruments to manage its exposure to foreign exchange risk arising from operating activities (cash flow hedge). Mithra's risk management objective is to hedge the US Dollars (USD) foreign currency exposure arising from the Estelle® license and supply agreement in USD between Mithra and Mayne Pharma LLC. Mithra has a transactional USD exposure of 228 million USD arising from the regulatory and sales related license milestones under the Mayne Pharma agreement. This exposure is hedged by forward exchange contracts maturing in the period 2020-2025 and entered into by Mithra Pharmaceuticals SA and Estetra SRL.
The Group uses debt instruments. In December 2020, the Group negotiated a EUR 125 million senior unsecured convertible bonds due 17 December 2025. The Bonds will be convertible into ordinary shares of the company. The Bonds were issued at 100% of their principal amount and bear a coupon of 4.250% per annum, payable semi-annualy in arrear in equal instalments on 17 December and 17 June of each year, beginning on 17 June 2021. With the convertible bonds, Mithra has secured the necessary financial resources to finance its business development strategy, and to carry on its R&D expenses.
No special events have occurred that could considerably impact the development of theGroup.
The Group's exposure to price risk, credit risk, liquidity risk and cash flow risk are detailed in note 9.3 (Financial Risk Management).
The Group has a business structure; built on: (i) a development portfolio which includes the development of Estetrol-based product candidates in the oral contraception, menopause indications as well as other potential indications such as wound healing, NHIE, Covid and of Complex Therapeutics; (ii) the CDMO development and manufacturing facility, which will manufacture an important part of its innovative products, including its Estetrolbased products (the growing importance of this business for Mithra has been confirmed by the interest shown by first rank international market actors in its innovative products portfolio and the achievements in this respect in terms of international business development), and (iii) a commercialized portfolio of branded generics, OTC products in several regions, and post-period Estelle® in Canada and in the US as well as in Europe. Therefore, the risk factors related to each of these pillars are presented separately (as each has a different set of risks associated with it). As Mithra further evolved towards a commercial biopharma company in 2021, most focus is on the development portfolio and products' commercial launch.
(i) Except Estelle®, no Estetrol-based product candidates have been formally registered nor commercialised and the lead product candidate Estelle® is currently approved in Canada and in the US, and received a positive CHMP opinion in Europe (formal approval anticipated in May2021), all of these events taking place post period. The successful development of the Group's Estetrol-based other product candidates remain highly uncertain. Estetrol-based product candidates must undergo pre-clinical and clinical testing supporting the clinical development thereof, the results of which, are uncertain and could substantially delay, which in turn could substantially increase costs, or prevent the Estetrol-based product candidates from reaching the market.
Except Estelle® in Canda in Europe and in the US, the Group's other Estetrol-based product candidates have not been approved nor commercialised..
In parallel, the agencies could requirea number of studies to be conducted which are not expected to have a significant impact on any (potential) marketing authorisation approval, although these will play a role in determining the labelling and leaflet restrictions the product candidate would have upon approval (if any). Donesta® for use in hormone therapy in menopause is currently in Phase III (the pre-clinical and Phase I clinical trial support package is shared with Estelle®; the data currently available would seem to suggest (but did not possess the statistical power to demonstrate) that Estetrol decreases hot flushes in a dose-dependent manner, but larger populations and longer treatment periods as recommended by regulatory guidance (12 weeks) will be necessary to optimally see a difference in the results between the different Estetrol doses tested and the placebo group) and to confirm the minimum effective dose of E4. Despite the recent positive opinion/approval on Estelle in threee main regions, all Estetrol-based product candidates will be subject to extensive (pre-)clinical trials supporting the clinical development thereof to demonstrate safety and efficacy in humans (which will take several years) before they can apply for the necessary regulatory approval to enter the market and potentially obtain marketing authorisation with the relevant regulatory authorities. The Group does not know whether future clinical trials will begin on time, will need to be redesigned will be completed on schedule (for Estelle® and Donesta® the activities announced for 2020 were completed with the filing activities for Estelle® and post period the obtention of the two first market authorizations as well as the positive opinion of the CHMP and the ongoing Phase 3 clinical trials for Donesta®), The precise timing estimates for the development and registration (if any) of Donesta® beyond the Phases of clinical development these product candidates is currently in is thus difficult to predict.
At any stage of development, based on review of available pre-clinical and clinical data, the estimated costs of continued development, the triggering of certain contingent payments and "royalty payments", (payable to the former shareholders of Uteron Pharma as part of the acquisition of Estetra by the Group), and up to EUR 12 million, for Donesta® (as described in the note on business combinations and asset deals), market considerations and other factors, the development of Estetrol-based product candidates may bediscontinued.
Any further delays in completing clinical trials or negative results will delay the Group's ability to generate revenues from product sales of Estetrol-based product candidates, if any. This could have a material adverse effect on the Group's business, prospects, financial condition and results of operation.
The Group's pipeline currently comprises three product candidates which would, upon their marketing authorisation, be completely original innovative products. The Group is dedicating the majority of its available cash resources to the development of these innovative Estetrol-based product candidates. If the Group would be unsuccessful in developing, commercialising and/or partnering these innovative original products, this would materially impact the revenue and profitability potential of the Group, as in that case, the nature of the Group's pipeline would be limited to the development (either directly or indirectly) of Complex Therapeutics and the further development of its commercial business, both of which present market opportunities of a level which is significantly lower than the opportunity offered by the development of innovative original products. Both of these activities have a profile which is more limited in terms of funding need and growth potential compared to the development of innovative product candidates.
(iii) In order to successfully develop, register and commercialise its Estetrol-based product candidates, the Group will need to successfully manage the transition from a focus on the commercialisation and development of generic products to a company that is in addition, to a significant extent, involved in development and commercialisation of innovative original product candidates.
The Group has, to date, received a market authorization in Canada and in the US as well as a positive opinion from CHMP in Europe for Estelle , but has never yet commercialised an innovative product candidate, and develop its other E4 based products such as Donesta. Such development, registration and commercialisation present significant new challenges.
In preparation, the Group has expanded and continues to expand its organisation and has attracted and continues to attract a number of experienced collaborators in this new field of development. However the Group may not be able to successfully integrate their experience and know-how, and to continue to further successfully expand its organisation and successfully conclude every development step. A failure to successfully do so could cause delays in the clinical development and/or the regulatory approval process, which could ultimately delay or even prevent the commercialisation of the Group's innovative product candidates. This could have a material adverse effect on the Group's business, prospects, financial condition and result ofoperation.
(iv) Complex therapeutics Zoreline® currently under development by the Group has not yet received any regulatory approval. Myring® received regulatory approval for Europe but is still waiting for it in the US. Complex Therapeutics must undergo bioequivalence or pharmacodynamics or any other studies, which could be subject to delays, which in turn could substantially increase costs, or prevent these generic products from reaching the market on time.
All complex therapeutics will be subject to bioequivalence or pharmacodynamics or other studies (as deemed fit by the relevant regulatory agencies), to demonstrate that the generic product is bioequivalent to the previously approved drug, before they can receive the necessary regulatory approval to enter the market. In 2016, Myring® was the first complex therapeutic solution produced by Mithra to demonstrate bioequivalence; for the other products (including Zoreline®), this is not yet the case. Any delays in completing studies, will delay the Group's ability to generate revenues from product sales of complex therapeutical solutions products if any. In case the Group would come late in the market, dependent on the market as of the point when three to five generics have been approved, it will suffer from significantly reduced market share, revenues and cashflows for the relevant genericproduct.
Upon completion of the relevant studies, the Group's products must obtain marketing approval from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) or competent regulatory authorities in other jurisdictions before the products can be commercialised in a given market, and each such approval will need to be periodically renewed. Each regulatory agency may impose its own requirements and may refuse to grant or may require additional data before granting marketing approval even if marketing approval has been granted by other agencies. Changes inregulatory approval policiesor enactment of additional regulatory approval requirements may delay or prevent the products from obtaining or renewing marketing approval. Also, post-approval manufacturing and marketing of the Group's products may show different safety and efficacy profiles to those demonstrated in the data on which approval to test or market said products was based. Such circumstances could lead to the withdrawal or suspension of approval. All of this could have a material adverse effect on the Group's business, prospects, financial condition and results of operation.
The Group's product candidates are being developed with the intention of a commercial launch throughout the world. The Company currently has no commercial, marketing and sales organisation in place that would allow it to launch its product candidates in these markets. As in 2016, the Group decided to put its affiliates on hold, it does not plan to build out a commercial organization in these territories.
The Company divested its French subsidiary, Mithra France, in December 2017. The sale consisted in two agreements. A first contract was closed with Laboratoire CCD, a French-based Women's Health player and concerns the transfer of the marketing authorizations (Mas) for four products including Tibelia®. Secondly, Mithra concluded a share purchase agreement for Mithra France with Theramex, whereby Theramex has taken over the subsidiary, including its pharmaceutical license. In 2020, the Company closed its Brazilian affiliate while the German one is in the process of dilution.
Until now the Group has never marketed a product outside of the Benelux and has therefore limited experience in the fields of sales, marketing and distribution in other markets. The Group does currently not intend to deploy itself a sales and distribution organisation elsewhere in the world, but will rely for the commercial launch and distribution of its products on license and supply deals with partners.
The new partners identified during the 2020 financial year are Alvogen (Hong-Kong and Taïwan), Mayne Pharma (Australia), Gynebio (North-Africa), Gedeon Richter ( South-America)for Estelle®. Farlitalia (Italy), Gynial (Switzerland), Zentiva (France, Uniked-Kingdom and Poland), Megalabs (Mexico); Chemical Dampe ( Venezuela) for Myring®, , Famitalia (Italy), Spirig Healthcare ( Liechtenstein and Switzerland) for Tibelia®, . . Other partners have currently not yet been identified and there can be no assurance that the Group will ever identify such partners or find an agreement with such partners. Therefore its products might not be commercialised in all the markets the Group currently intends to commercialise its products. The Group's dependence on partners for the commercialisation of its products in certain regions results in a number of risks (including, but notlimited to, less control over the partner's use of resources, timing, success, marketing of competing products by the partner, impact of future businesscombinations).
The Company has entered into some partnerships regarding sourcing of raw materials including essential active pharmaceutical ingredients such as E4. Therefore the possibility for the Company to meet its production's commitments towards their counterparts depend on its sourcing arrangements and its partners' compliance with their own obligations, commitments which may have been impacted by COVID or any other drawbacks that the Company's partners may have faced during these challenging economical times.
The market for pharmaceutical products is highly competitive. The Group's competitors in the Women's Health market include many established pharmaceutical, biotechnology and chemical companies, such as Bayer, MSD, Pfizer, Therapeutics MD, Exeltis and Allergan, many of which have substantially larger financial, research and development, marketing and personnel resources than the Group and could, therefore, more quickly adapt to changes in the marketplace and regulatory environment. Competitors may currently be developing, or may in the future develop technologies and products that are more effective, safe or economically viable than any current or future technology or product of the Group. Competing products may gain faster or broader market acceptance than the Group's products (if and when marketed) and medical advances or rapid technological development by competitors may result in the Group's product candidates becoming non-competitive or obsolete before the Group is able to recover its research and development and commercialisation expenses. This could have a material adverse effect on the Group's business, prospects, financial condition and results of operation.
The success of the Group will depend in part on its ability to obtain, maintain and enforce its patents and other intellectual property rights for technologies and products in all territories of interest to the Group. The Group directly holds various families of patent for Estelle® and Donesta®. The two patent families covering the indications for contraception and menopause will expire in 2022 in Europe and Canada and in 2025 in the United States (i.e., only a few years after the end of the development of these two product candidates). New patent applications have been filed to strengthen the protection of the product candidates, the outcome and scope of which are still undetermined. The Group also holds five families protecting different synthesis pathways for Estetrol, whose main patents expire in 2032. The Group will also seek to protect market opportunities for these products candidates once marketing authorization is granted (where applicable) through market/data exclusivity systems (between three and ten years maximum depending on the territory) and/or by applying for extensions of patent terms (five years maximum) where this possibility exists.
The Group has experienced operating losses since 2012. It experienced consolidated net losses of EUR 9.8 million in 2015, EUR 35 million in 2016, EUR 35 million in 2017, EUR 12.4 million in 2018, and EUR 26.6 million in 2019, and EUR 92.1 million in 2020. These losses have resulted principally from costs incurred in research & development and from general and administrative costs associated with the operations. In the future, the Group intends to continue the clinical trial program for its candidate products, conduct pre-clinical trials in support of clinical development and regulatory compliance activities that, together with anticipated general and administrative expenses, and the construction and start-up of its CDMO, will result in the Group incurring further significant losses for the next several years and the Group's cash burn is expected to increase as a result of these activities in the next fewyears.
There can be no assurance that the Group will ever earn significant revenues or achieve profitability resulting from its research and development activities.
The Group is also subject to the following risks, in addition to the risks mentionedabove:
The occurrence of unforeseen or catastrophic events, including extreme weather events and other natural disasters, man-made disasters, or the emergence of epidemics or pandemics, depending on their scale, may cause different degrees of damage to the national and local economies and could cause a disruption in the Company's operations and have a material adverse effect on its financial condition and results of operations. Man-made disasters, pandemics, and other events connected with the regions in which the Company operates could have similar effects. If a natural disaster, health pandemic, or other event beyond its control occurred that prevented the Company from using all or a significant portion of its office and/or lab spaces, damaged critical infrastructure, such as its manufacturing facilities or its manufacturing facilities of its third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult for the Company to continue its business for a substantial period of time.
On March 11, 2020 the World Health Organization declared the novel strain of coronavirus (COVID-19) a global pandemic and recommended containment and mitigation measures worldwide. As of the date of this Annual Report, Belgium, where the Company operates, has been impacted by temporary closures. The length or severity of this pandemic cannot be predicted, but the Company currently anticipates that there may be a potential impact from COVID-19 on the planned development activities of the Company.
With COVID-19 continuing to spread in the United States and Europe, the business operations of the Company could be delayed or interrupted, particularly if a large portion of its employees become ill. COVID-19 may also affect employees of third-party organizations located in affected geographies that the Company relies upon to carry out its clinical trials. The spread of COVID-19, or another infectious disease, could also negatively affect the operations at its third-party suppliers, which could result in delays or disruptions in the supply of drug product used in its clinical trials. In addition, the Company is taking temporary precautionary measures intended to help minimize the risk of the virus to its employees, including temporarily requiring all employees to work remotely, suspending all non-essential travel worldwide for its employees and discouraging employee attendance at industry events and in-person work-related meetings, which could negatively affect the Company's business.
Further, timely enrollment in clinical trials is reliant on clinical trial sites which may be adversely affected by global health matters, including, among other things, pandemics such as COVID-19. For example, many of the Company's clinical trial sites are located in regions currently being afflicted by COVID-19. Some factors from the COVID-19 outbreak that the Company believes will adversely affect enrollment in its trials at least on a temporary basis include:
The impact of COVID-19 on its business is uncertain at this time and will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among other things, but prolonged closures or other business disruptions may negatively affect its operations and the operations of its agents, contractors, consultants or collaborators, which could have a material adverse impact its business, results of operations and financial condition.
We are committed to fully exploiting the potential of E4 (Estetrol) as well as our technologic platform in Complex Therapeutics to develop a diverse and broad portfolio of therapeutic treatments focused on Women's Health.
With regard to E4, most focus is on Mithra's late-stage product candidates, Estelle® for contraception (Post period, market authorization approval for Canada and US, as well as positive CHMP opinion received for Europe and Donesta® for menopause (Phase III). Furthermore, Mithra is exploring additional indications in Women's Health (e.g. dysmenorrhea, pain related to endometriosis), as well as indications beyond Women's Health, such as Covid-19 treatment, wound healing and neuroprotection.
In January 2020, an ecotoxicity study revealed that Estetrol had a more environmentally friendly profile compared to other estrogens. Additional comparative studies are ongoing at the University of Namur to deepen this finding. In November 2020, the Company received the qualification of Estetrol as a "New Active Substance" (NAS) by the European Medicines Agency (EMA). This is the first NAS designation in contraception in over 80 years and the achievements of many years of work for the Company. Post period, the Company received its first market authorization for Canada and a second market authorization is expected for Europe following the positive opinion of the CHMP.
Finalization of patient enrolment for the Phase III E4Comfort program of oral hormonal therapy Donesta® (menopause), which is expected to be completed in early Q2 2021. The Data Safety Monitoring Board (DSMB) independent expert committee issued a positive opinion at the end of 2020, allowing the clinical trials to continue as planned. Despite the Covid-19, the clinical program is currently almost on track.
The recruitment of patients is still ongoing for the clinical program on Estetrol's effect in Covid-19 treatment. This Phase II "Coronesta" trial aims to study the action of Estetrol on the immune, inflammatory and vascular response of patients (male/female) infected with Covid-19. It is in line with other international studies, such as the one conducted at King's College London, which demonstrated the protective effect of estrogen present in the body at high levels. The results of the Coronesta study are expected in early H2 2021.
Indeed, the Covid-19 pandemic led us to review our R&D pipeline. In 2020, we focused on the regulatory procedures linked to the approval of Estelle®, the development of Donesta® and identified a new opportunity with the Coronesta program relating to the potential of Estetrol in the field of respiratory diseases which might broaden the use of Estetrol beyond women's health. Regarding PeriNesta®, although the clinical program has not yet been launched, the opportunistic development previously announced is under review together with other development strategies under consideration in order to fully leverage the potential of this product candidate. •
Further strengthening Estetrol Intellectual Property portfolio thanks to a new patent extending the 35 patent-family filed by Mithra. Exclusivity of Estelle® and Donesta® product candidates is extended until 2036 in Europe. A similar application is currently being examined in the United States.
For the Complex Therapeutics, Mithra launched Myring® in Europe (Belgium, Luxembourg, Czech Republic and Germany) and is currently compiling the additional data requested by the FDA for the US launch. After the removal of requirement for special temperature storage ,the shelf life of Myring® was extended to 36 months from 24 months by the European Authorities, offering distributors, pharmacists and patients a more convenient option compared to competitor products.
At the same time, the Company continue to advance our research work on Zoreline® formulations, having obtained supportive 1 and 3-month PK results in 2018.
Furthermore, Mithra will pursue the budgeted investments to further advance the technological CDMO facility in terms of performance, applicability and scale; in order to offer third-parties the opportunity to develop sterile injectables; and to prepare the polymeric forms and hormonal tablets zones for the production of its proprietary products.
In addition, Mithra intends to initiate new discovery programs which might lead to the development and commercialization of drug candidates; and is committed to seek, maintain and expand the know-how, technologies and intellectual property position.
The Directors report that during the financial year under review seven decisions have been taken that fall within the provisions of Art.. 7:96 of the CCA namely three of those are linked to the LDA Capital transaction and two are linked to the issuance of warrant plans. As required by the law, thoseminutes parts of the relevant meetings of the Board of Directors relating to such conflicts of interest are reproduced hereunder.
Furthermore, during the same financial year, there has been no transaction or other contractual relationship between the Group, and a Director or Executive Manager other than those that fall within the provisions of Art. 7:96 of the CCA or that have been disclosed under "related party transactions" set out below pursuant to Art. 7:97 of the CCA.
On April 20, 2020, at 4:00 p.m., the Board of Directors (hereinafter the "Board") of SA MITHRA PHARMACEUTICALS (hereinafter the "Company") met by means of phone call
The President reminds and reads Article 7:96 of the CCA. In the presence of a conflict of interest situation, the concerned director must inform the other directors of its conflict before the Board of Directors can make a decision. The Board of Directors must provide in its minutes the statement and explanations as to the nature of the opposing interest as well as the nature of the decision or transaction in question and a rationale for the decision that was made and the financial consequences for the Company. The minutes of the meeting will be shared with the Company's statutory auditor.
Mr. Fornieri takes the floor to inform before any deliberation on the item on the agenda and in particular before deliberation on item b), "Update regarding the financial transaction with LDA Capital," that there is a potential conflict of interest concerning him and that of the Company within the meaning of Art 7:96 of the CCA.
He explains the following reasons why he considers the transaction to involve an opposition of interests: In the course of the negotiations with LDA Capital, they have requested, in order to secure the transaction, that shares be temporarily lent to LDA Capital. In this context, it is likely that Mr. Fornieri will be required to lend his shares. He would then be interested in the transaction as a shareholder as well. As a result, Mr. Fornieri states that he is potentially in a situation of conflict of interest of a patrimonial nature.
By a special vote by a simple majority, the Board of Directors confirm the existence of a potential conflict of interest and the need to follow the CCA procedure Mr. Fornieri leaves the meeting to avoid any deliberation on the operation and does not take part in the vote related thereto. The statutory auditor will be informed of the conflict of interest and of the Board of Directors' decision. This part of the minutes is included in full in the management report or in a piece that will be filed at the same time as the annual accounts.
The CFO wishes to update the Board of Directors on the current financing project with LDA Capital. In this regard, a note has been sent to the Board (Annex V') to give an image of the ongoing "corporate" operations and the steps that will be useful for their implementation. This note to the Board could only be sent once certain negotiating points had been finalized.
The CFO explains that the case is progressing well. The latest discussions focus on the issuance of warrants for LDA Capital and the lending of shares by the reference shareholders as interim guarantee of the drawdowns.
To date, the transaction includes two important documents:
o Put option agreement: A commitment of up to EUR 50M which allows the Company to make successive puts at its own discretion on both the timing and the amount. We may not use the full amount that is available to us. This draft provides for a fee of 1.5% to be paid in the coming year depending on the puts or in the absence of a put, in the year that the granting of this facility is granted.
This document regulates the issuance of shares for LDA and the sequencing of transactions:
o X-5: Mithra's notification of its willingness to draw and the amount;
o X-3: Lender shareholders must offer to pledge a number of shares equal to the amount of the draw.
o X-2, the shareholders lenders put their shares in a blocked account for the benefit of LDA, specially opened within a Belgian bank guaranteed by LDA for the benefit of the lenders, and this for an amount equivalent to that of the draw This transfer involves a transfer of ownership of the shares and rights attached to them for the benefit of LDA, which is therefore free to trade them.
o X-1, the shares are on the pledged account.
o At X, Mithra makes its formal request for a draw. The amount of the draw is based on the volume of transactions on Mithra securities the 15 days before the draw request. To date, we are subject to low transaction volumes (25 to 30,000 per day). The first draw could be in the order of EUR 10M. A period of 30 days of trading then runs (pricing period), during which A calculation of VWAP is made. On this VWAP we apply a 10% discount. This volume determines the price of the shares to be issued on behalf of LDA, on the understanding that LDA is obliged to subscribe to a minimum amount of 75% of the draw. This amount is then converted into a capital increase (issue of new shares for LDA). The drawing process takes time and during this period (between the drawing and the issuance of the shares), it is up to the reference shareholders (identity of which is yet to be determined) to put their shares on loan during this period
o At X-31, LDA must take a position (sending a closing notice) as to the number of shares to be issued for its profit and the subscription price
o X -34. The Company issues the shares for the benefit of LDA, which gives Mithra an irrevocable mandate to return them to the lending shareholders. In practice, therefore, the shares lent remain with LDA, and the new shares are immediately returned to the lending shareholders.
o Mithra has one month to list new shares. These shares, once listed, are returned to the reference shareholders who have lent their shares to the former.
o Directors must pay particular attention to one element: The risks for reference shareholders. It is also possible that at the end of the process, LDA will be declared bankrupt. There is therefore a counterparty risk on this point. To limit this risk, we requested that the loaned shares be deposited into an individualized title account (distinct from other assets that LDA may have), which is the subject of a pledge to the benefit of the lender shareholders. Shares and cash generated by trading these shares will also be placed on this account. To mitigate this risk, the Company requested the integration of two elements into the contract:
o No possibility of selling more than 1/3 per day of the shares transferred by the shareholder lender;
o Inability to trade more than 75% of pledged shares;
o Fixing a "minimum acquisition price" (MAP). Mithra determines this price with each put option notice.
o LDA's obligation not to trade more than 75% of all shares lent corresponding to the minimum of the shares to be issued as part of the upcoming capital increase.
The CFO summarizes the situation and reminds Mithra's point of view. Without LDA, the Company risks having a problem with the banks. Indeed, at present, the banks are expressing their intention to support the Company (Belfius, ING...). However, ING wants a specific background contribution beforehand and in the LDA sequence is essential. For Belfius, they would like to know the extent of ING's participation (which would be between 30 and 50M) to intervene. LDA would therefore be a lever for obtaining future bank loans.
Mr Hoffman states that from reading the letters received, Belfius requested a parallel intervene of the reference shareholders. The CFO indicates that it is negotiating firmly to avoid such a scenario. In light of this information, the Chairman questions whether or not a capital increase should be made for the benefit of the reference shareholders. The CFO indicates that this may no longer be a necessity.
Mr Servais has in the past expressed doubts about the ability to reach an agreement with the banks. He is pleased to see that this option is now possible. However, Mr. Servais points out that we are looking for a quick financing solution. We must avoid procrastinating too much and entering into tenuous negotiations with the banks.
The President indicated that he was in line with Mr Servais' concern and that swift action was needed. The President is re-feeling a nervousness of the banks with regard to the situation. Decisions must be taken at this Board. Reference shareholders must take a position on capital intervention alongside banks for the future.
Independent directors intervene and agree that if the reference shareholders participate in a capital increase and put their shares on loan to LDA, they must be able to benefit from a consideration such as the granting of warrants. In this regard, Mr. Hoffman proposes to hold a separate meeting with the Company's independent directors and counsel to shed light on the possibility of granting existing warrants to the lending shareholders. He is insist about the fact that the gesture of the reference shareholders must be paid in one way or another. In view of the potential conflict of interest that such a discussion might engender in this Board, this point will be discussed at a later date in the absence of the concerned people.
Finally, the CFO questions Mr Moretti, in his capacity of shareholder, in order to find out whether or not he agrees to support the LDA transaction by putting his shares on loan. Mr. Moretti gives an agreement in principle under certain reservations that he must lift. The Chairman as a shareholder also agrees to lend his shares as long as the loan is remunerated in one way or another. This should be included in a package combined with a capital increase in which the benchmark shares (e.g., an ABB) participates. The CFO is in favour of this initiative, but the ABB should, in its view, intervene only if necessary and the timing is defined.
Mr Servais wants to speed up operations and have a clear point of view on whether or not existing warrants can be granted to reference shareholders.
Decision: After review and discussion, the Board considers LDA Capital to be a financial partner for the Company and decides to vote favourably on the continuation of negotiations on the basis of the elements described at this Boardl. In order to facilitate the conclusion of this transaction, the Board of Directors believes that certain powers should be delegated to management and the managing director. Despite the potential conflict of interest that affects the managing director, in view of his status, his position with respect to LDA Capital and the negotiations that have already lasted for a few weeks, but also in the corporate interest of the Company, the Board decides knowingly to delegate to the CEO any power to represent the Board, to negotiate, finalize and sign the final contractual and legal documents inherent to the transaction as a whole. Within the framework that has been presented to the Board today. The Board specifies, however, that if the transaction were to be completed, it would be subject to formal ratification by the Board at the next meeting.
On April 27, 2020, at 9:30 a.m., the Board of Directors (hereinafter the "Board") of SA MITHRA PHARMACEUTICALS (hereinafter the "Company") met by means of phone call.
The President reminds and reads Article 7:96 of the CCA In the presence of a conflict of interest situation, the concerned director must inform the other directors before the Board of Directors can make a decision. The Board of Directors must provide in its minutes the statement and explanations as to the nature of the opposing interest as well as the nature of the decision or transaction in question and a rationale for the decision that was made and the financial consequences for the Company The minutes of the meeting will be shared to the statutory auditor of the Company.
Prior to proceeding with the deliberations, the following directors previously communicated that they were in a conflict with item (b) on the agenda: (i) Alychlo NV (Marc Coucke), (ii) Aubisque BVBA (Freya Loncin), (iii) YIMA SRL (François Fornieri), (iv) NOSHAQ SA (Gaetan).
These directors have informed the other directors that they potentially have an opposite interest of a patrimonial nature to the decisions in point (b) and (c) are on the agenda:
In addition, in accordance with Appendix H of the Company's Corporate Governance Code, the aforementioned directors state that they are not in a position to make an entirely independant decision regarding items (b) and (c) of the agenda.
The Chair thanks the Directors for their statements in this minutes which will have the conflict of interest part of the minutes attached to the management report 2020 pursuant to the article 7:96 CSA procedure.
The Board of Directors does consider that the aforementioned directors are potentially in a conflict of interest situation so that the requirements of Art 7:96 of the CCA and Schedule H of the Corporate Governance Code should be complied with. Accordingly, the Board of Directors notes that it is more prudent for the four directors concerned not to participate in this meeting and refrain from voting on this point.
The Board of Directors then validly deliberate on the item on the agenda.
Mr Hoffman begins the meeting by asking a question about the agreement with LDA Capital. He wants to be sure that "private placement" transactions are not prevented or made more difficult by the agreement.
According to the CFO, the change of control covered by the agreement do not relate to transactions." Mr Hoffman wants a decision beforehand. Management is invited to asstain the impact of such transactions on the agreement with LDA Capital. The CLO and the CFO indicate that a note will be provided on this matter.
The management also asks about the fate of the share pledged? Can they be sold in the next three years? The CFO explains that the share loan takes place for a period of 30 and 45 days. Once the draw is made, the loaned shares are released. Only the draw is guaranteed by those actions. Mr. Hoffman insists that this is still a lock-up for a certain period of time. The distribution of the shares pledged between the lenders shareholders has not yet been decided at this stage.
The Board questions the possibility of Mr Moretti pledging his shares? Mr. Moretti explains that for tax reasons, there can be no discontinuity in the ownership of the shares. Threfore, he will not lend his shares.
The Board invites management to inquire about the tax implications under Belgian law of such a share loan.
The contractual documents were provided to the Board as well as internal notes summarizing the steps of the transaction on the occasion of the previous Board. After deliberation, the Board is unanimous in its view that this transaction was favourable to the Company since
LDA Capital commits to a cash funding of up to 50 million euros ("capital commitment") for a period of up to three years in exchange for new Mithra shares. This provision of funds, if any immediate, is essential in order to secure the going of concern of the company, to secure its balance sheet and to compensate for the inconvenience caused by the epidemic of Covid-19;
This capital commitment will be released through draws in the form of put op-tion options that the Company may exercise at its sole discretion. It will allow the Company to release funds as it needs to, rather than immediately diluting existing shareholders for an aggregate amount that the Company may not need, given other potential additional financing options (borrowing, other investment funds, private placement of reference shareholders or combination of these measures) , which will be implemented in the short and medium term to support the growth strategy and strengthen the balance sheet, as announced last March when the 2019 annual figures were published;
This type of financing is appropriate for the flexibility it offers in this crucial year for the Company, which is marking its transition into a commercial biotech company and which will be punctuated by major advances for its entire product portfolio, in particular the expected commercial launch of its Myring contraceptive ring® in the three largest global markets in 2020, the production of the safety-stock of its contraceptive pill Estelle® for its planned commercialisation in 2021 , not to mention the continuation of Phase III studies of his next-generation hormone treating Donesta®.
Decision: After review, the Board of Direcotrs unanimously decides with the present members to ratify the "put option agreement" between the Company and LDA Capital Limited and LDA Capital LLC.
As noted above, the Commission emphasizes that the reference shareholders will have to sacrifice a portion of their shares in order to secure the transaction for LDA Capital. The Commission is well aware that this loan must be remunerated on normal market conditions that can be validly justified with respect to third parties. It highlights the fact that without this intervention by the lending shareholders, the Company would not have been able to benefit from the funds made available by LDA, which, as previously explained, were necessary.
Mr. Hoffman explained in this regard that a meeting of independent directors was held at this subject in the presence of the Company's lawyer. At the end of the meeting, three options proved to be possible:
Use of the Company's existing warrants: This will not be possible in relation to the specific purpose of the plan;
Developing a new warrant plan with more flexibility
Use of the LDA plan and transpose it to the benefit of the reference shareholders. This solution is indisputable because validated by the General Assembly, knowing that the reference shareholders that have more than 10% of the shares of the Company cannot participate in the vote. In the latter case, however, the risk of the Assembly not approving the plan is present.
Mr Hoffman recommends combining solutions 2 and 3 at the same time. Cancel the existing warrants plan, make it a more flexible one and model the LDA plan for shareholder lenders.
According to the CLO, this solution is favoured by the Company's lawyer. However, it highlights the risk of not being able to secure the vote in terms of a majority. In his view, a legally acceptable solution will have to be found in order to secure this vote.
Decision: The Board unanimously decides to proceed with the remuneration of the lending shareholders by granting warrants. The Commission invites independent directors to meet as soon as possible to settle the terms and conditions, including the quantum of this remuneration under normal market conditions. A proposal will be put forward by the latter at the next Council.
This Board of Directors aimed at increasing the capital by means of the authorized capital to enable the Board to draw the LDA Capital funding pursuant to the put option agreement as executed on the 23rd April 2020. This Board of Directors was held before a notary public, minutes of which is published in the Appendixes of the Belgian Official Gazette and supporting documents on the Company's website.
In light of this decision, several conflict of interest were disclosed by directors.
Introduction by the Chairman
The Chairman reminds that article 7:96 of the Companies and Associations Code states in its first paragraph that "Art. 7:96. § 1. When the board of directors is called upon to take a decision or to decide on a transaction within its competence in which a director has a direct or indirect interest of a proprietary nature which is opposed to the interests of the company, that director must inform the other directors before the board of directors takes a decision. His declaration and explanation of the nature of the conflicting interest must be included in the minutes of the meeting of the board of directors at which the decision is to be made. The board of directors may not delegate its decision. "
In this case, the Board must indicate in its minutes the nature of the decision or transaction in question and a justification for the decision that was made as well as the financial consequences for the Company.
After the above-mentioned introduction by the Chairman, each of (a) YIMA SRL, represented by its permanent representative, Mr. Francesco Fornieri, (b) ALYCHLO NV, represented by its permanent representative, Mr. Marc Coucke, (c) NOSHAQ SA, represented by its permanent representative Mr. Gaëtan Servais, and, insofar as necessary, (d) AUBISQUE BV, represented by its permanent representative, Mrs. Freya Loncin, all four mentioned above, has indicated insofar as necessary and applicable that it has a potential conflict of interest within the meaning of article 7: 96 of the Code of Companies and Associations with respect to the proposed resolutions on the agenda of this meeting of the Board of Directors.
YIMA SRL informed the meeting that it is a related person of Mr. Francesco Fornieri, a shareholder of the Company. ALYCHLO NV informed the meeting that it is a shareholder of the Company. NOSHAQ SA has informed the meeting that it is a shareholder of the Company. AUBISQUE BV informed the meeting that it is also an advisor to ALYCHLO NV.
YIMA SRL, ALYCHLO NV, NOSHAQ SA and AUBISQUE BV informed the meeting that the Put Option Agreement referred to above in the agenda of this board meeting provides that when the Company exercises its put option, Mr. Francesco Fornieri, ALYCHLO NV and NOSHAQ SA shall lend to LDA a number of existing shares covering the amount of the put option. The loan of shares shall enable LDA to cover its risks against the amount it has to pay following the exercise of the put option. For more information, reference is made by each of them to the report of the board of directors mentioned in the agenda section.
AUBISQUE BV informs the meeting that in its capacity as advisor to ALYCHLO NV and in view of the latter's potential conflict, it has decided not to participate in the deliberations and resolutions.
YIMA SRL, ALYCHLO NV, NOSHAQ SA and AUBISQUE BV have therefore each declared, to the extent necessary and applicable, that they may have a potential conflict of interest within the meaning of article 7:96 of the Companies and Associations Code with respect to the resolutions to be taken by the board of directors concerning the capital increase of the Company. YIMA SRL, ALYCHLO NV, NOSHAQ SA and AUBISQUE BV will also inform the Company's auditor of the foregoing, to the extent necessary and applicable, in accordance with the provisions of Article 7:96 Companies and Associations Code. However, notwithstanding this potential conflict, YIMA SRL, ALYCHLO NV, NOSHAQ SA and AUBISQUE BV have all stated that they believe that the proposed transaction is in the best interest of the Company, as it would allow the Company to complete the capital increase and raise new funds, which is in the Company's best interest. For further information, reference is made by each of them to the report of the board of directors mentioned in the agenda section.
Subsequently, YIMA SRL, ALYCHLO NV, NOSHAQ SA and AUBISQUE BV did not participate in the deliberations and resolutions of the board of directors in connection with the proposed private placement.
None of the other directors have declared that they have an interest in the transaction that would require the application of the procedure provided for in articles 7:96 and/or 7:97 of the Companies and Associations Code.
The other members of the board of directors have taken note of the preliminary statements made by YIMA SRL, ALYCHLO NV, NOSHAQ SA and AUBISQUE BV.
The board of directors is of the opinion that the report of the board of directors referred to under item 1 of the agenda regarding the capital increase, which is submitted to the board of directors for approval, (a) contains a description of the nature of the capital increase, (b) a description of the capital consequences of the capital increase for the Company, as well as for the existing shareholders and holders of subscription rights of the Company, respectively, and (c) contains the justification of the capital increase. This report of the board of directors contains additional information and will be made public via (inter alia) the website of the Company and is, to the extent necessary, incorporated by reference in the minutes of this board of directors' meeting.
The board of directors also notes that the present capital increase is an implementation of the Put Option Agreement which is mentioned in the agenda of the present meeting and was previously approved by the board of directors. In addition, to the extent necessary and applicable, in accordance with Section 7:97 of the Companies and Associations Code, the independent directors of the company have earlier evaluated the proposed transaction and have concluded, in connection with the proposed capital increase, that the Put Option Agreement is in the best interest of the company. The Board of Directors concurs with and does not depart from the conclusion and considerations of the independent directors, which were reflected in the aforementioned Board Report.
The board of directors of the Company resolves to approve the report of the board of directors in accordance with article 7:198 juncto articles 7:179, 7:191 and 7:193 of the Companies and Associations Code of March 23, 2019 (the "Companies and Associations Code") in connection with the proposal of the board of directors of the Company, within the framework of the authorized capital, to increase the capital of the Company in cash for a maximum amount of FIFTY MILLION EUROS (EUR 50,000. 50,000,000.00 (including share premium) by issuing a number of new shares at an issue price yet to be determined, and to cancel, in the interest of the Company, the preferential subscription rights of the existing shareholders of the Company and, to the extent necessary, of the existing holders of subscription rights of the Company, in favor of LDA Capital Limited (and its successors and permitted assigns, as provided for in the Put Option Agreement) ("LDA"), the whole as further described in the report. The Board of Directors expressly authorizes each director to sign the aforementioned Board of Directors' Report in the name and on behalf of the Board of Directors.
Suspension of the meeting of the Board of Directors
After the approval of the above-mentioned report of the board of directors, the meeting was briefly suspended in order to allow the Company's auditor to finalize and submit his report mentioned under item 2. of the agenda of the present meeting. After this short break, the meeting, still constituted as above, shall resume its course.
The board of directors takes note of the report of the statutory auditor of the Company in accordance with article 7:198 juncto articles 7:179, 7:191 and 7:193 of the Code of Companies and Associations in relation to the proposal of the board of directors of the Company, within the framework of the authorized capital, to increase the capital of the Company in cash for a maximum amount of FIFTY MILLION EUROS (EUR 50. 50,000,000.00 (including issue premium) by issuing a number of new shares at an issue price to be determined, and to cancel, in the interest of the Company, the preferential subscription rights of the existing shareholders of the Company and, insofar as necessary, of the current holders of subscription rights of the Company, in favor of LDA. All of the Appearances acknowledge that they have received a copy of this report in due time and take note of it. The report will be filed in the Company's file with the clerk of the competent corporate court. The Board of Directors also notes that there are no comments on the report of the Company's auditor.
The chairman is exempted from reading the report of the board of directors and the report of the statutory auditor, Mr. Cedric Antonelli, auditor, of the civil partnership BDO Bedrijfsrevisoren, with registered office at 1935 Zaventem, Da Vincilaan, 9, Boc E.6, The Corporate Village, Elsinore Building designated by the board of directors, reports established within the framework of article 7:198 juncto articles 7:179, 7:191 and 7:193 of the Companies and Associations Code. Both reports shall remain attached hereto.
The Board of Directors of the Company decides to increase the capital of the Company, within the framework of the authorized capital as described in Article 7 of the Company's articles of association, in cash for a maximum amount of FIFTY MILLION EUROS (EUR 50,000. 50,000,000.00) (including issue premium) by the issuance of a number of new shares at an issue price yet to be determined, and to cancel, in the interest of the Company, the preferential subscription rights of the existing shareholders of the Company and, to the extent necessary, of the existing holders of subscription rights of the Company, in favor of LDA, subject to the following conditions:
(a) Capital increase: The board of directors uses its powers under the authorized capital as set forth in Article 7 of the Company's articles of association to increase the Company's capital in cash for a maximum amount of EUR 50,000,000.00 (including the issue premium) (the "Commitment Amount") through the issuance of a number of new shares at an issue price yet to be determined as provided below. The capital increase is subject to the condition precedent of the completion of the subscription of the new shares by LDA in accordance with the terms below.
(b) Number of new shares to be issued and issue price of the new shares: The number of new shares to be issued in connection with the capital increase and the issue price of such new shares (representing the capital of the Company for the amount equal to the par value and, if applicable, the issue premium for what would exceed the par value) shall be determined by the board of directors or the Placement Committee (as defined below) on the basis of the terms and conditions set forth in the Put Option Agreement, dated April 23, 2020, which has been entered into by and among the Company, LDA Capital Limited and the other parties named therein (the "Put Option Agreement"), it being understood that, among other things:
(i) depending on when the Company notifies LDA of the exercise of a put option requiring LDA to subscribe for new shares, the new shares to be issued may have a different issue price in accordance with the Put Option Agreement,
(ii) whenever the Company exercises a put option, the relevant number of new shares to be issued shall be determined on the basis of the trading volumes and prices of the Company's shares on Euronext Brussels during the relevant reference period prior to the exercise of the put option, in accordance with the terms of, and subject to the adjustments set forth in, the Put Option Agreement
(iii) whenever the Company exercises a put option, the relevant issue price of the new shares to be issued shall be determined on the basis of 90% of the relevant volume weighted average trading price of the Company's shares on Euronext Brussels during the relevant reference period (30 to 45 trading days) following the exercise of the put option, in accordance with the terms of, and subject to the adjustments set forth in, the Put Option Agreement
(iv) the minimum issue price of the new shares shall not be less than EUR 19.50 (subject to the adjustment mechanism provided for in the Put Option Agreement), and
(v) the aggregate issue price of the new shares to be issued in the framework of the capital increase (composed of the number of new shares to be issued, multiplied by the applicable issue price of the relevant shares) must not be higher than the Commitment Amount;
all as further described in the report of the board of directors referred to under item 1 of the agenda.
(c) Allocation of the issue price of the new shares: The issue price of the new shares must be fully paid up at the time of issue and subscription of the new shares by LDA. The issue price of each new share must be recorded as capital on the liabilities side of the Company's balance sheet, as equity in the "Capital" account. However, the amount by which the issue price of a new share exceeds the par value of the existing shares of the Company (which, at the date of this decision, amounts to, rounded to EUR 0.7321) will be accounted for as share premium, if any, on the liabilities side of the balance sheet of the Company as shareholders' equity in the account "Share premium". This account will constitute, in the same way as the Company's capital, a guarantee for third parties and, except for the possibility of capitalizing these reserves, may only be reduced or eliminated by a decision of the general meeting of shareholders ruling under the conditions required for the amendment of the Company's articles of association. Following the capital increase and the issue of the new shares, all existing and outstanding shares of the Company (including the newly issued shares) will, in accordance with article 7:178 of the Companies and Associations Code, have the same accounting par value.
(d) Nature and form of the new shares: The new shares to be issued in connection with the capital increase shall have the same rights and benefits as the existing and outstanding shares of the Company at the time of their issuance and shall in all respects, including dividend rights, be pari passu with the existing and outstanding shares of the Company at the time of their issuance, and shall be entitled to distributions for which the record date or due date falls on or after the date of issuance of new shares. The Company will apply for the admission of the new shares to trading on the regulated market of Euronext Brussels in accordance with applicable laws and regulations and the terms and conditions of the Put Option Agreement.
(e) Offering of the New Shares: The New Shares will be offered by the Company to LDA, and may be subscribed for by LDA in accordance with the terms and conditions of the Put Option Agreement. LDA is obligated to subscribe for the New Shares in accordance with the terms and conditions set forth in the Put Option Agreement.
(f) Removal of Preferential Right: In order to allow the offering of the New Shares by the Company to LDA and the subscription of the New Shares by LDA as provided for above, the board of directors resolves, in accordance with article 7:198 juncto articles 7:191 and 7: 193 of the Companies and Associations Code, to waive, in the interest of the Company, the preferential subscription rights of the existing shareholders of the Company and, to the extent necessary, of the existing holders of subscription rights of the Company, in connection with the proposed capital increase in favor of LDA Capital Limited and its successors and permitted assigns (as referred to and described in the report of the board of directors referred to in agenda item 1), as provided for by the Put Option Agreement.
(g) Implementation of the capital increase, issuance and subscription of the new shares: Subject to the provisions of the preceding paragraphs and subject to the terms and conditions of the Put Option Agreement, the board of directors or the Placement Committee shall determine the practical implementation of the issuance of, and subscription by LDA for, the New Shares, including (but not limited to) the maximum number of New Shares to be issued, the issue price of the New Shares to be issued, the timing of the issuance of and subscription for the New Shares, and the resulting increase in capital, the terms and conditions of subscription for the shares and other mechanisms for effecting the transaction.
(h) Completion in several tranches: Subject to the effective completion of the issue and the subscription of the new shares, the capital increase may be completed in one or more tranches, depending on the exercise of one or more put options by the Company in accordance with the Put Option Agreement. If all of the new shares offered are not subscribed for, the capital increase may nevertheless be carried out to the extent of all or part of the subscriptions received by the Company in accordance with the Put Agreement, to be determined as set forth above, in accordance with article 7:198 juncto article 7:181 of the Belgian Companies and Associations Code, provided that the board of directors or the Placement Committee so decides in accordance with the terms and conditions of the Put Agreement. The board of directors or the Investment Committee may also, for the avoidance of doubt, decide not to implement the envisaged capital increase.
(i) Amendment of the articles of association: Upon completion of the capital increase and the issuance of the new shares as provided for above, the articles of association of the company shall be amended and updated to reflect the resulting capital and the number of existing and outstanding shares.
(j) Appointment of a Placement Committee: The board of directors hereby appoints a committee (the "Placement Committee") consisting of at least two persons, of whom (x) one shall be a director, and (y) the other shall be the Chief Financial Officer (or any director (other than the director referred to in (x) above) if the Chief Financial Officer is not available). The Investment Committee shall have the power and ability to implement the effective completion of the capital increase, in accordance with the provisions of paragraphs (a) to (i) above, and shall have, but not be limited to, the following powers
(i) to exercise the put options in accordance with the Put Option Agreement;
(ii) to determine the number and issue price of the new shares to be issued in connection with the capital increase
(iii) to implement the issue and subscription of the new shares;
(iv) (without prejudice to the provisions of the Put Option Agreement) to determine the start and duration of the issue and subscription period and, as the case may be, the end of the issue and subscription period for the new shares, as contemplated by the foregoing decisions, and to decide not to start or to end the issue and subscription period or to start or to end the issue and subscription for only part of the new shares (v) to take all useful or necessary steps with the competent regulatory authorities and Euronext Brussels with respect to the admission to trading of the new shares on the regulated market of Euronext Brussels;
(vi) to take note of the fulfilment of the conditions precedent, to proceed with the realisation and the fixing of the capital increase as provided for above, with the resulting amendment of the articles of association of the company and, if applicable, with the fixing of the amount of the issue premium; and
(vii) to do all other useful, appropriate or necessary things in connection with the foregoing, including representing the Company before a notary in order to record the effective realization of the subsequent capital increase transactions.
The Placement Committee is authorized to sub-delegate (in whole or in part) the exercise of the powers conferred upon it by virtue of this decision. The Investment Committee shall be validly represented by each member of the Investment Committee, acting individually.
(k) Specific powers: Pursuant to article 7:198 juncto article 7:186 of the Companies and Associations Code, the realization of the capital increase may be recorded at the request of the board of directors, the Placement Committee, each director of the Company, the corporate secretary, the Chief Financial Officer and the Legal Manager, who are hereby individually and specifically designated for this purpose. The above powers are in addition to, and without prejudice to, any other powers granted by the board of directors in connection with the proposed capital increase.
Vote: This resolution is adopted unanimously.
This Board of Directors aimed at increasing the capital by means of the authorized capital to formalize the private placement via accelerated bookbuilding offering in the terms announced on the same day. This Board of Directors was held before a notary public, minutes of which is published in the Appendixes of the Belgian Official Gazette and supporting documents on the Company's website.
In light of this decision, several conflict of interest were disclosed by directors.
Prior to the deliberations and resolutions of the board of directors, Mr. François Fornieri, Alychlo NV (having as permanent representative Mr. Marc Coucke) and Noshaq SA (having as permanent representative Gaëtan Servais), each a director of the Company, made the following respective declarations to the extent necessary and applicable, in accordance with Article 7:96 of the Companies and Associations Code:
Each of the foregoing directors has represented that he or she is currently a stockholder of the Company, that he or she supports the proposed Transaction to be considered by the Company, and that, subject to the initiation of the Transaction, he or she intends to submit an order in the Transaction.
The aforementioned directors have each informed the meeting that, as a result, they may have a conflict of interest within the meaning of Article 7:96 of the Companies and Associations Code in connection with the decisions to be taken by the board of directors in connection with the Transaction. They shall also inform the Company's statutory auditor of the foregoing, to the extent necessary and applicable, in accordance with the provisions of Article 7:96 and/or Article 7:97 of the Companies and Associations Code. However, notwithstanding this potential conflict, the Directors have all stated that they believe that the proposed private placement is in the best interests of the Company, as it will enable the Company to complete the Transaction and raise new funds, which is indeed in the best interests of the Company.
Thereafter, the aforementioned directors have not participated in the deliberations and decisions of the board of directors in connection with the Transaction.
None of the other directors declared that they had an interest in the Transaction that would require the application of the procedure set forth in Articles 7:96 and/or 7:97 of the Companies and Associations Code.
The remaining members of the board of directors have taken note of the prior declarations made by Mr. F. Fornieri, Alychlo NV and Noshaq SA (the "Subscribing Shareholders").
The board of directors has considered that the Board's Report prepared in accordance with article 7:198 juncto articles 7:179 and 7:191 of the Belgian Companies and Associations Code in connection with the Transaction and which is submitted for approval by the board of directors contains (a) a description of the nature of the Transaction, (b) a description of the financial consequences of the Transaction for the Company, as well as for the existing shareholders and the holders of the respective outstanding subscription rights of the Company, and (c) the justification of the Transaction. The Board Report also contains additional information and will be publicly available via (among others) the Company's website and is, to the extent necessary, incorporated by reference into the minutes of this board meeting.
The board of directors has also specified that, subject to the launch of the Transaction, the Transaction will be open to institutional, qualified, professional and/or other investors as permitted under the applicable private placement exceptions, as mentioned in the aforementioned report, and any final allocation to investors, if any, will be made on the basis of customary objective and pre-determined criteria. The board of directors has further confirmed that no assurances will be given with respect to the final allocation to the Subscribing Shareholders, or any other participating investor, or any of their affiliates or other persons, with respect to any allocation to them, or the size of any such allocation.
In addition, to the extent necessary and applicable, in accordance with Article 7:97 of the Companies and Associations Code, an ad hoc committee of three independent directors of the Company (consisting of P. Suinen SRL, Castors Development NV, Patricia van Dijck) have earlier evaluated the Proposed Transaction and have concluded, in connection with the proposed capital increase, that the Transaction is in the interest of the Company. The conclusions of the Committee are as follows:
The Committee believes that the proposed Transaction, and the potential participation of the Subscribing Shareholders (Mr. François Fornieri, Alychlo NV and Noshaq SA) in it, are in the interest of the Company and all its shareholders.
In particular, the subscription of new shares by the Subscribing Shareholders demonstrates the support of the reference shareholders for the activity, vision and strategy of the Company. This may contribute to the success of the Transaction. A successful fund raising would be in the interest of the Company because, among other things, it allows the Company to have access to equity financing (from the Subscribing Shareholders and other investors) in a fast and efficient manner to finance its activities.
In any event, the Committee notes that the offering of new shares will be open to institutional, accredited, professional and/or other investors, as permitted by the applicable private placement exceptions, and that any final allocation to investors, as the case may be, will be made on the basis of customary objective and pre-identified criteria. No assurances will be or have been given as to the final allocation to any of the aforementioned investors, stockholders or other persons, that an allocation will be made to them, or as to the extent of any such allocation.
The Board of Directors concurs with and does not depart from the conclusions and considerations of the Committee of Independent Directors, which have been reflected in the aforementioned Board Report.
After the foregoing statements have been made and the meeting is declared to be properly constituted and able to transact business, the remaining directors of the Board of Directors shall proceed with the business of the meeting and, after deliberation, shall pass the following resolutions
(a) The board of directors resolves to approve the report of the board of directors pursuant to article 7:198 juncto articles 7:179 and 7:191 of the Companies and Associations Code of March 23, 2019 (the "Companies and Associations Code"), as well as, to the extent necessary and applicable, the report prepared pursuant to article 7: 97 of the Companies and Associations Code by an ad hoc committee of three independent directors of the Company (consisting of Ahok BV, Castors Development NV, Patricia Van dijck), both reports having been prepared in connection with the proposal of the board of directors of the Company, within the framework of the authorized capital, to increase the capital of the Company in cash for a maximum amount of THREE MILLION TWO HUNDRED AND FOURTY-FOUR THOUSAND EUROS (EUR 3. 294,450.00) (excluding issue premium, if any) through the issue of a maximum number of new shares amounting to FOUR MILLION FIVE HUNDRED THOUSAND (4,500. 000) and to cancel, in the interest of the Company, the preferential subscription rights of the existing shareholders of the Company and, to the extent necessary, of the existing holders of subscription rights of the Company, in connection with the proposed issuance of new shares to be offered via a private placement, through an accelerated bookbuilding procedure to a large, currently unknown group of Belgian and foreign institutional, qualified, professional and/or other investors (including private persons, subject to applicable laws, rules and regulations of financial law, and it being understood, with respect to investors other than qualified investors (as defined in Regulation 2017/1129 of the European Parliament and of the Council of June 14, 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market and repealing Directive 2003/71/EC, as amended (the "Prospectus Regulation")) in Belgium only, that the minimum investment amount per investor shall be at least EUR 100. 000) in Belgium and abroad (including Qualified Institutional Buyers (QIBS) in the United States), based on the applicable private placement exemptions;
(b) The board of directors takes note of the report of the Company's auditor pursuant to article 7:198 juncto articles 7:179 and 7:191 of the Companies and Associations Code, as well as the report of the Company's auditor pursuant to article 7: 97 of the Companies and Associations Code, both reports having been prepared in connection with the proposal of the Company's Board of Directors, within the framework of the authorized capital, to increase the Company's capital in cash for a maximum amount of THREE MILLION TWO HUNDRED AND FOURTY THOUSAND FOUR HUNDRED EUROS (EUR 3. 294,450.00 (excluding issue premium, if any) by the issuance of a maximum number of new shares amounting to FOUR MILLION FIVE HUNDRED THOUSAND (4,500,000) and to cancel, in the interest of the Company, the preferential subscription rights of the existing shareholders of the Company and, insofar as necessary, of the current holders of subscription rights of the Company, in relation to the proposed issuance of new shares
All of the Appearances acknowledge that they have received a copy of the report of the Board of Directors, the report of the ad hoc committee of three independent directors of the Company and the reports of the Company's auditor in a timely manner and take note thereof. The reports will be filed in the Company's file with the appropriate corporate court. The Board of Directors also notes that there are no comments on the reports of the Company's auditor.
The chairman of the meeting is exempted from reading the report of the board of directors and the report of the statutory auditor, Mr. Cedric Antonelli, auditor, of the civil partnership BDO Bedrijfsrevisoren, with registered office at 1935 Zaventem, Da Vincilaan, 9, Boc E.6, The Corporate Village, Elsinore Building designated by the board of directors, reports drawn up in the framework of article 7:198 juncto articles 7:179 and 7:191 of the Companies and Associations Code. Both reports shall remain attached hereto.
The board of directors decides to increase the capital of the Company in cash within the framework of the authorized capital, as defined in article 7 of the articles of association of the Company, for a maximum amount of THREE MILLION TWO HUNDRED AND FOURTY-FOUR THOUSAND EUROS (EUR 3,294,450.00) (excluding issue premium, if any) by issuing a maximum number of new shares amounting to FOUR MILLION FIVE HUNDRED THOUSAND (4. 500,000), with cancellation of the preferential subscription rights of the existing shareholders of the Company and, insofar as necessary, of the existing holders of subscription rights of the Company (in each case, not in favor of one or more specific persons), subject to the following conditions
(a) Capital increase: The board of directors shall use its powers within the framework of the authorized capital as set forth in Article 7 of the Company's articles of association to increase the Company's capital for a maximum amount of THREE MILLION TWO HUNDRED AND NINETY-FOUR THOUSAND AND FOUR HUNDRED EUROS (EUR 3. 294,450.00) (excluding issue premium, if any) through the issue of a maximum number of new shares amounting to FOUR MILLION FIVE HUNDRED THOUSAND (4,500,000). The capital increase is subject to the condition precedent that the offer and the allocation of the new shares are carried out as provided below.
(b) Issue price: The issue price of the new shares (representing the capital of the Company for the amount equal to the fractional value and, as the case may be, the issue premium for what would exceed the fractional value) will be determined by the board of directors or the Placement Committee (as defined below), which will have the power to do so in consultation with the Underwriters (as defined below), on the basis, inter alia, of the results of the accelerated bookbuilding procedure referred to below.
(c) Allocation of the issue price of the new shares: The issue price of the new shares must be fully paid up at the time of issue and subscription of the new shares. The issue price must be recorded as capital on the liabilities side of the Company's balance sheet, as equity under the account "Capital", i.e. a maximum amount of THREE MILLION TWO HUNDRED AND FOURTY-FOUR THOUSAND EUROS (EUR 3,294,450.00). However, the amount by which the issue price of the new shares exceeds the accounting par value of the existing shares of the Company (i.e., rounded up to EUR 0.7321) will be accounted for as an issue premium, as the case may be, on the liabilities side of the balance sheet of the Company as equity on the account "Issue Premium". This account will constitute, in the same way as the Company's capital, a guarantee for third parties and, except for the possibility of capitalization of these reserves, may only be reduced or eliminated by a decision of the general meeting of shareholders ruling under the conditions required for the amendment of the Company's articles of association. After the capital increase and the issue of the new shares, each share (new and existing) will represent the same fraction of the Company's capital.
(d) Nature and form of the new shares: The new shares to be issued in connection with the capital increase shall have the same rights and benefits, and shall be pari passu in all respects, including dividend rights, with the existing and outstanding shares of the Company at the time of their issuance, and shall be entitled to distributions for which the record date or due date falls on or after the date of issuance of the new shares. The Company will apply for the admission of the new shares to trading on the regulated market of Euronext Brussels in accordance with applicable laws and regulations.
(e) Offering of the new shares: The new shares will be offered by one or more investment banks designated by the Company (such designated investment banks are collectively referred to as the "Underwriters") to offer the new shares, through an accelerated bookbuilding procedure, to a large, currently unknown group of Belgian and foreign (institutional, qualified professional and/or other Belgian and foreign investors (including private persons, subject to applicable laws, rules and regulations of financial law, and being understood, as regards investors other than qualified investors (as defined in the Prospectus Regulations) in Belgium only, that the minimum investment amount per investor will be at least EUR 100. 000) in Belgium and abroad (including Qualified Institutional Buyers (QIBS) in the United States), based on the applicable private placement exemptions.
(f) Cancellation of the preferential subscription right: In order to allow the offering of the new shares as provided for above, the board of directors decides, in the interest of the Company, to cancel the preferential subscription right of the existing shareholders of the Company and, to the extent necessary, of the existing holders of subscription rights of the Company, in accordance with article 7:198 juncto article 7: 191 of the Companies and Associations Code, in order to allow the Underwriters to offer the new shares, through an accelerated order book procedure, to a large, currently unknown group of Belgian and foreign institutional, qualified, professional and/or other investors (including private persons, subject to applicable laws, rules and regulations of financial law, and being understood, as regards investors other than qualified investors (as defined in the Prospectus Regulations) in Belgium only, that the minimum investment amount per investor will be at least € 100. 000) in Belgium and abroad (including Qualified Institutional Buyers (QIBS) in the United States), based on the applicable private placement exemptions.
(g) Implementation of the capital increase and the offering of the new shares: Subject to applicable corporate and financial law provisions, and subject to the provisions of the foregoing paragraphs, the board of directors or the Placement Committee (if applicable, in consultation with the Underwriters) shall further determine the practical implementation of the offering and the allocation of the New Shares in accordance with the foregoing, including (but not limited to) the maximum number of New Shares offered, the commencement and termination of the offering of the New Shares and the resulting capital increase, the jurisdictions in which the offering of the New Shares will take place, the terms and conditions of the subscription for the Offered Shares and other mechanisms for the completion of the transaction.
(h) Start and end of the offering: The offering shall start immediately after the decision of the board of directors to approve the capital increase and shall end at the latest thirty (30) days after the start of the offering. Subject to the effective completion of the offering and the allocation of the new shares, the capital increase can be completed in one or more tranches. If all of the offered new shares are not subscribed for, the capital increase may nevertheless be realized to the extent of all or part of the subscriptions received and accepted by the Company at the applicable issue price, to be determined as aforesaid, in accordance with article 7:198 juncto article 7:181 of the Belgian Companies and Associations Code, provided that the board of directors or the Placement Committee so decides. Even if all the shares offered are subscribed for, the capital increase may be effected by issuing fewer shares than the number of subscriptions received by the Company at the applicable issue price, to be determined as aforesaid, provided that the board of directors or the Investment Committee so decides. The board of directors or the Placement Committee may also, for the avoidance of doubt, decide not to carry out the envisaged capital increase, even if all or part of the new shares offered are subscribed for.
(i) Amendment of the articles of association: Following the capital increase and the issuance of the new shares as provided for above, the articles of association of the company will be amended and updated to reflect the resulting capital and the number of existing and outstanding shares.
(j) Appointment of Investment Committee: The Board of Directors hereby appoints a committee (the "Placement Committee") consisting of at least two persons, of whom (x) one shall be Koen Hoffman (or any other director other than a director participating in the Private Placement, if Koen Hoffman is not available), and (y) the other must be the Chief Financial Officer (or any director (other than the director referred to in (x) above and other than a director participating in the private placement) if the Chief Financial Officer is not available). The Placement Committee shall have the flexibility and power to implement the capital increase, subject to the provisions of paragraphs (a) to (i) above, including (without limitation) the power to (i) determine the number and issue price of the new shares to be issued under the capital increase, (ii) implement the subscription, offering and allocation of the new shares pursuant to the aforementioned private placement and the accelerated bookbuilding procedure, (iii) to determine, on behalf of the Company, the scope, terms and conditions of the services to be offered by the Underwriters, as well as the scope, terms and conditions of the underwriting by the Underwriters as provided for above, (iv) to determine the beginning and duration of the subscription period and the offering and, if applicable (iv) to determine the beginning and the duration of the subscription and offering period and, as the case may be, the end of the subscription and offering period for the new shares, as contemplated by the foregoing decisions, or to decide not to commence or to terminate the subscription and offering period or to commence or to terminate the subscription and offering period for only a part of the new shares, (v) to take all useful or necessary steps with the competent regulatory authorities and Euronext Brussels with respect to the admission to trading of the new shares on the regulated market of Euronext Brussels (vi) to take note of the fulfilment of the conditions precedent, to proceed with the realisation and the fixing of the capital increase as provided for above, with the resulting amendment of the articles of association of the company and, if applicable, with the fixing of the amount of the issue premium, and (vii) to do all other useful, appropriate or necessary things in relation to the foregoing. The Placement Committee is authorized to sub-delegate (in whole or in part) the exercise of the powers conferred upon it by virtue of this decision. The Investment Committee shall be validly represented by each member of the Investment Committee, acting individually.
(k) Specific powers: Pursuant to article 7:198 juncto article 7:186 of the Companies and Associations Code, the realization of the capital increase may be recorded at the request of the board of directors, the Placement Committee, each director of the Company, the corporate secretary, the Chief Financial Officer and the Legal Manager, who are hereby individually and specifically designated for this purpose. The above powers are in addition to, and without prejudice to, any other powers granted by the board of directors prior to this decision in the context of the proposed capital increase.
Vote: this resolution is adopted unanimously.
This Board of Directors issued by means of the authorized capital a new Warrant Plan pursuant to the CCA in replacement of the 2018 Warrant Plan which was in conformity with the former Code of Companies, terms of wish were disclosed on the same day. This Board of Directors was held before a notary public, minutes of which is published in the Appendixes of the Belgian Official Gazette and supporting documents on the Company's website
In light of this decision, several conflict of interest were disclosed by directors.
After the above-mentioned introduction by the Chairman, each of YIMA SRL, represented by its permanent representative, Mr. Francesco Fornieri, and Eva Consulting SRL, represented by its permanent representative, Mr. Jean-Michel Froidart, both mentioned above, has indicated as far as necessary and applicable that they have a potential conflict of interest within the meaning of article 7:96 of the Code of Companies and Associations with respect to the proposals of decisions included in the agenda of this meeting of the Board of Directors
YIMA SRL and EVA CONSULTING SRL inform the meeting that, as executive directors, each of them qualifies as a Selected Participant within the meaning of the 2020 Rights Plan. Therefore, each of YIMA SRL and EVA CONSULTING SRL is eligible to be granted 2020 Share Options. For further information, reference is made by each of them to the report of the Board of Directors mentioned in section 1. of the agenda and to the "2020 Stock Option Plan" attached to these minutes.
YIMA SRL and EVA CONSULTING SRL have therefore each declared, to the extent necessary and applicable, that they have a potential conflict of interest within the meaning of Article 7:96 of the Companies and Associations Code with respect to the decisions to be taken by the board of directors regarding the issuance within the framework of the authorized capital of three hundred and ninety thousand seven hundred and seventeen (390. 717) 2020 Share Options in favor of the Selected Participants and the decision to no longer grant three hundred and ninety thousand seven hundred and seventeen (390,717) share options issued under the 2018 Warrant Plan. YIMA SRL and EVA CONSULTING SRL will also inform the statutory auditor of the Company of the foregoing, as far as necessary and applicable, in accordance with the provisions of Article 7:96 Companies and Associations Code.
However, notwithstanding this potential conflict, YIMA SRL and EVA CONSULTING SRL have each stated that they believe that the proposed issuance of the 2020 Share Options and the decision to no longer grant a number of share options issued under the 2018 Warrant Plan are in the best interest of the Company, as they allow the Company to create a new share option plan in accordance with the provisions of the Companies and Associations Code, consisting of a number of 2020 Share Options equal to the number of share options not yet granted to the selected participants under the "2018 Warrant Plan", and because the 2020 Share Option Plan is in the best interest of the Company, as further explained in the report of the Board of Directors to be submitted to the Board of Directors.
Thereafter, YIMA SRL and EVA CONSULTING SRL have not participated in any further deliberations and decisions of the board of directors in connection with the proposed issuance of the 2020 Share Options and the decision to no longer grant a number of subscription rights issued under the 2018 Warrant Plan.
None of the other directors has declared that they have an interest in the transaction that would require the application of the procedure set forth in Articles 7:96 and/or 7:97 of the Companies and Associations Code.
(…)
The board of directors of the Company resolves to approve the report of the board of directors pursuant to article 7:198 juncto articles 7:180 and 7:191 of the Companies and Associations Code of March 23, 2019 (as amended from time to time) (the "Companies and Associations Code") regarding the proposal to issue, within the framework of the authorized capital, three hundred and ninety thousand seven hundred and seventeen (390. 717) new share options (the "2020 Share Options"), pursuant to a share option plan called the "2020 Share Option Plan", and to waive, in the interest of the Company, the preferential subscription rights of the existing shareholders of the Company and, to the extent necessary, of the holders of outstanding share options of the Company, in favor of the employees within the meaning of Article 1:27 of the Belgian Companies and Associations Code ("the Selected Participants") The board of directors expressly authorizes each director to sign the aforementioned board of directors' report in the name and on behalf of the board of directors.
VOTE: The vote on the Board of Directors' Report was unanimous.
The board of directors of the Company resolves to approve and confirm the instruction to the statutory auditor of the Company to prepare a report in accordance with article 7:198 juncto articles 7:180 and 7:191 of the Companies and Associations Code regarding the proposal to issue, within the framework of the authorized capital, three hundred and ninety thousand seven hundred and seventeen (390. 717) 2020 Share Options and to cancel, in the interest of the Company, the preferential right of the existing shareholders of the Company and, to the extent necessary, of the holders of outstanding subscription rights (share options) of the Company, in favor of the Selected Participants, and takes note that, to the extent necessary and applicable, in accordance with Article 3:63, §5 of the Companies and Associations Code, the members of the audit committee approve that such an instruction, in accordance with the necessary rules and conditions, be given to the statutory auditor of the Company.
Suspension of the meeting of the Board of Directors
After the approval of the above-mentioned report of the Board of Directors and the instruction given to the auditor, the meeting was briefly suspended in order to allow the auditor of the Corporation to finalize and submit his report mentioned in item 3 of the agenda of the present meeting. After this brief recess, the meeting, still constituted as above, shall resume.
The board of directors takes note of the report of the statutory auditor of the Company in accordance with article 7:198 juncto articles 7:180 and 7:191 of the Companies and Associations Code regarding the proposal to issue, within the framework of the authorized capital, three hundred and ninety thousand seven hundred and seventeen (390,717) 2020 Share Options and to cancel, in the interest of the Company, the preferential subscription rights of the existing shareholders of the Company and, as far as necessary, of the holders of outstanding subscription rights (share options) of the Company, in favor of the Selected Participants. The board of directors takes note that there are no comments on the report of the statutory auditor of the Company.
The board of directors resolves to issue, within the framework of the authorized capital as defined in article 7 of the articles of association of the Company, three hundred and ninety thousand seven hundred and seventeen (390. 717) 2020 Share Options, pursuant to a share option plan called the "2020 Share Option Plan", and to cancel, in the interest of the Company, the preferential subscription rights of the existing shareholders of the Company and, to the extent necessary, of the holders of outstanding share options of the Company, in favor of the Selected Participants. Consequently, the board of directors decides as follows
(a) Terms and conditions of the 2020 Share Options: The terms and conditions of the 2020 Share Options shall be as set forth in the "2020 Share Option Rights Plan" attached to the report of the board of directors referred to in item 1. of the agenda (for the purposes hereof, the "Plan"), a copy of which shall remain attached to these minutes. The main terms of the 2020 Share Options can, for information purposes, be summarized as follows:
(i) Rights to subscribe for ordinary shares: Each 2020 Share Option entitles the holder to subscribe for one new share to be issued by the Company.
(ii) Exercise price: The exercise price of a 2020 Share Option shall be determined by the board of directors.
Provided that the shares of the Company are listed or traded on a regulated market (or other trading platform) on the date of grant, the exercise price of a 2020 Share Option shall be at least equal, at the option of the board of directors, to either (i) the average of the closing prices of the share as quoted on the relevant market on which the shares of the Company will then be listed or traded during the thirty (30) day or any other relevant period determined by the board of directors on the basis of foreign legal or tax provisions, preceding the grant date, or (ii) the closing price of the share as quoted on the relevant market on which the Company's shares will then be quoted or traded on the day preceding the grant date.
If the Company's shares are not listed on a regulated market on the date of grant, the exercise price of a 2020 Share Option shall be at least equal to the fair market value of the shares, as determined by the board of directors with the unanimous consent of the Company's auditor. In any event, such exercise price shall never be less than the book value of the shares (based on the Company's most recent unconsolidated financial statements).
The exercise price is subject to customary downward adjustments in the event of certain dilutive actions of the Company (such as the payment of a dividend or the issuance of new shares).
(iii) Term: The 2020 Share Options have a term of ten years from their date of issue.
(iv) Exercisability: The exercise of the 2020 Share Options is subject to the terms and conditions set forth in the Plan.
(v) Transferability: Except as otherwise provided in the applicable 2020 Share Option agreement, the 2020 Share Options may not be transferred by a Selected Participant except in accordance with the terms and conditions set forth in the Plan. The 2020 Share Options shall not be admitted to trading or listing.
(b) Underlying Shares: Each 2020 Share Option entitles the holder to subscribe for one new share to be issued by the Company. The new shares to be issued upon exercise of the 2020 Share Options shall have the same rights and benefits, and shall be pari passu in all respects, including dividend rights, with the existing and outstanding shares of the Company at the time of their issuance, and shall be entitled to distributions for which the record date or expiration date falls on or after the date of issuance of the shares.
(c) Waiver of Preference Rights in Favor of Selected Participants: The board of directors resolves, in accordance with article 7:198 juncto article 7:191 of the Companies and Associations Code, to cancel, in the interest of the Company, the preferential subscription right of the existing shareholders of the Company and, to the extent necessary, of the holders of outstanding subscription rights (share options) of the Company, in favor of the Selected Participants, as further explained in the report of the board of directors referred to under item 1. of the agenda.
(d) Grant of 2020 Share Options: The board of directors resolves that the 2020 Share Options may be granted to the Selected Participants in accordance with the Plan.
(e) Conditional Capital Increase and Issuance of New Shares: The board of directors resolves, subject to and to the extent of the exercise of the 2020 Share Options, to increase the capital of the Company and to issue the appropriate number of new shares issuable upon exercise of the 2020 Share Options. Subject to and in accordance with the provisions of the Plan, upon exercise of the 2020 Share Options and the issuance of new shares, the full amount of the exercise price of the 2020 Share Options shall be applied to the capital of the Company. To the extent that the amount of the exercise price of the 2020 Share Options, per share to be issued upon exercise of the 2020 Share Options, exceeds the fractional value of the Company's shares then existing immediately prior to the issuance of the relevant new shares, a portion of the exercise price, per share to be issued upon exercise of the 2020 Share Options, equal to such fractional value shall be recorded as capital, with the balance recorded as additional paid-in capital. Following the capital increase and the issue of new shares, each new and existing share will represent the same fraction of the Company's capital.
(f) Share premium: In accordance with article 8 of the Company's articles of association, any share premium that is booked in relation to the 2020 Share Options shall be booked to an unavailable account on the liabilities side of the Company's balance sheet within its equity, and the account to which the share premium is booked shall constitute, in the same way as the Company's capital, a guarantee for third parties and, unless such reserves can be capitalized, may only be reduced or eliminated by a decision of the general meeting of shareholders acting in accordance with the conditions required for the amendment of the Company's articles of association.
(g) Special powers: Without prejudice to the powers of the board of directors to administer the Plan and to delegate such powers in accordance with the provisions of the Plan, the board of directors, as well as each of the directors of the Company, the Chief Financial Officer of the Company and the Corporate Secretary of the Company each acting individually and with the possibility of sub-delegation and power of subrogation, shall have the power, upon exercise of the 2020 Share Options, to (A) record the increase in capital and the issuance of new shares resulting from such exercise, (B) allocate the capital and (if applicable) the share premium and (C) the amendment of the articles of association of the Company to reflect the new capital and number of outstanding shares following the exercise of the 2020 Share Options, (ii) to sign and deliver, on behalf of the Company, the relevant Euroclear, Euronext and bank documentation, the share register and all necessary documents in relation to the issuance and delivery of shares to the Selected Participant and (iii) do all things that may be necessary or useful (including, without limitation, the preparation and execution of all documents and forms) for the admission of the shares issued upon exercise of the 2020 Share Options to trading on the regulated market of Euronext Brussels (or any other market on which the Company's shares will be traded at that time).
VOTE: The vote on this decision was unanimous.
On November 25, 2020, at 4:00 p.m., the Board of Directors (hereinafter the "Board") of SA MITHRA PHARMACEUTICALS (hereinafter the "Company") met by phone call .
Prior to the deliberation and the Board's resolutions, Yima SRL (represented by Mr François Fornieri), as far as necessary and applicable, in accordance with Article 7:96 of the CSA, that since item 7) on the agenda is intended, among other things, to grant subscription rights issued under the 2020 Warrant Plan to Mr. François Fornieri (its permanent representative) , it could find itself in a conflict of interest situation within the meaning of Article 7:96 of the CCA in relation to the said decisions to be taken by the Board on item 7) of the agenda. Yima SRL (represented by Mr François Fornieri) will also inform statutory auditor of the Company of the above, if applicable, in accordance with the provisions of Article 7:96 of the CCA.
The other members of the Board took note of YIMA SRL's opening statement.
The Board of Directors is of the view that the Board's report prepared and approved as part of the adoption of the 2020 Plan and the issuance of the subscription rights under the 2020 Plan, which is available on the Company's website, (i) contains a description of the nature of the issuance of the subscription rights, (ii) a description of the patrimonial consequences of that issue for the Company , as well as for the Company's existing and outstanding underwriting rights holders respectively, and (iii) provides a rationale for the issuance of the 2020 Share Options. This Board report contains additional information and is, as far as necessary, fully incorporated in the minutes of this Board meeting.
Mr. Koen Hoffman, representing Ahok BV, informed the meeting that, in view of the ongoing Boardl renewal process, the decision on the grant of subscription rights should be differed at an upcoming Board meeting to which the new coopted members of the Board will be able to attend. Mr. Koen Hoffman also clarified that he did not question the specific knowledge and added value of ComEx members who were being considered for signing rights under the 2020 Plan.
The other members of the Board are of the view that the granting of the subscription rights issued under the 2020 Plan must be carried out by the Board in its current composition, as this grant is in relation to the benefits of the CEOs, CFO and Chief Supply Chain Officer, which the new coopedt members of the Commission can hardly assess since they were not members of the Board during this period. In addition, the other members of the Board consider that granting the subscription rights today will allow the newly formed Board to fully focus on implementing the Company's strategic transition to an international operational phase.
On the basis of Mr. Koen Hoffman's remarks, the other members of the Board also propose that Ms. Patricia van Dijck, in her capacity of Interim President, inform the new coopted members of the Board of the grant of subscription rights issued under the 2020 Plan to CEOs, CFO and Chief Supply Chain Officer.
Decision: Given their specific knowledge and added value to the Company, the Board unanimously decides, less abstention of Ahok BV (represented by Mr. Koen Hoffman), to grant 200,000 subscription rights issued under the 2020 Plan to the CEO, 100,000 subscription rights issued under the 2020 Plan to the CFO and 15,000 subscription rights issued under the 2020 Plan to the Chief Supply Chain Officer. The Board also unanimously decides, minus the abstention of Ahok BV (represented by Mr. Koen Hoffman), to mandate Ms. Patricia van Dijck, in her capacity as Interim Chairman, to inform the new coopted members of the Board of the grant of subscription rights issued under the 2020 Plan to CEOs, CFO and Chief Supply Chain Officer.
On December 22, 2020, at 6:30 p.m., the Board of Directors (hereinafter the "Board") of SA MITHRA PHARMACEUTICALS (hereinafter the "Company") met by phone call .
1) Renewal of the service agreement of Eva Consutling SRL ( Jean-Michel Foidart)
Before the Board's deliberation and decision-making, Eva Consulting SRL (represented by Jean-Michel Foidart) declares, as far as necessary and applicable, in accordance with Article 7:96 of the CCA, since the only item on the agenda is the renewal of its service contract, it may find itself in a conflict of interest situation within the meaning of Article 7:96 of the CCA in relation to the Board's decision in relation to the only item on the agenda. Eva Consulting SRL (represented by Jean-Michel Foidart) will also inform the statutory auditor of the above, if applicable, in accordance with the provisions of Article 7:96 of the CCA.
None of the other directors stated that they had an interest that would require the application of the procedure under sections 7:96 and/or 7:97 of the CCA.
The other members of the Board took note of the opening statement made by Eva Consulting SRL (represented by Jean-Michel Foidart).
The Board also noted the favourable opinion of the Nomineration and Remuneration Committee with respect to the annual renewal of Eva Consulting SRL's service contract (represented by Jean-Michel Foidart) based on the same financial terms as those applicable in 2020.
Renewal of the service agreement of Eva Consutling SRL ( Jean-Michel Foidart)
Decision: After deliberation, and taking into account the opinion of the Nomination and Remuneration Committee, the Board unanimously decides to approve the annual renewal of Eva Consulting SRL's service contract (represented by Jean-Michel Foidart).
As previously disclosed, the Risk and Audit Committte is composed of the following three members: : (i) two of which satisfy to the independence criterias as set forth by provision 7:87, §1st CCA and (ii) all of them meet the expertise requirement of that very article:
TicaConsult BVBA (Erik Van Den Eynden) has more than 30 years' experience in banking. After joining ING (formerly BBL) in 1990, he held various commercial and management positions throughout the bank, including director of a branch district, CEO of ING Insurance Belgium, Luxembourg & Variable Annuities Europe, head of MidCorporates and Institutionals at ING in Belgium and most recently CEO of ING in Belgium from 2017 to 2020. He holds a degree in economics from the University of Antwerp.
TicaConsult BVBA also satisfies the independence criteria as prescribed by provision 7:87, §1st CCA.
AHOK BVBA (standing representative: Mr Koen Hoffman) – Mr Hoffman obtained a Master of Applied Economics at the University of Ghent in 1990, followed by an MBA at Vlerick Business School in Ghent in 1991. He started his career in the Corporate Finance Bank at KBC Bank, in 1992. From October 2012 to July 2016, he was Chief Executive Officer of KBC Securities SA. He was a member of the Supervisory Board of KBC IFIMA SA (formerly KBC Internationale Financieringsmaatschappij N.V.) and of Patria Securities, as well as a member of the Board of Directors of Omnia Travel Belgium. Mr Hoffman is the Chief Executive Officer of Value Square and has been an Independent Director of Fagron SA since August 2016. He is also an independent chairman of the board of directors in the listed companies Greenyard, MDxHealth and Snowworld.
AHOK BVBA also satisfies the independence criteria as prescribed by provision 526ter of the BCC (now 7:87, §1st CCA).
NOSHAQ SA (standing representative: Mr Gaëtan Servais) - Mr Servais is a graduate in economics from the University of Liège, where he began his career as a research assistant. In 1995, Mr Servais joined the Federal Plan Budget as an expert and, following this, the Economic and Social Council of the Walloon Region. From 2001, he was private secretary to a number of Ministers in the Walloon Government. Since 2007, has been CEO of Meusinvest, a financial company whose business is structured into a number of subsidiaries in order to best meet the financing needs for small to medium enterprises (SME) located in the Province of Liège.
End of 2020, Mithra has a total of EUR 219.8 million accumulated losses on its balance sheet and realized a consolidated net loss of EUR 92.1 million for the year ended 31 December 2020. The Board of Directors has analyzed the financial statements and accounting policies and based on conservative assumptions, the current cash position of EUR 138.7 million at 31 December 2020 will allow the Group to keep up with operating expenses and capital expenditure requirements at least until the end of 2021.
Based on their assessment, the Management and Board of Directors consider it appropriate to prepare the financial statements on a going concern basis. The assessment is based on expected R&D clinical results and further business deals as well as on the monitoring of our funding activities, noting that an amount of EUR 66.8 million is currenty available based on existing contractual facilities (a capital commitment line with LDA Capital Limited for up to EUR 46.8 million and a bank loan of EUR 20 million fully undrawn and committed until June 2022).
The uncertainly raised by the COVID-19 pandemic is not impacting going concern. Although there are lot of uncertainties, it does not impact the Company's ability to continue operations during the next twelve months.
Mithra Pharmaceuticals SA, the parent Company, ended the financial year 2020 with a net loss of EUR 21,297,574.
The Board of Directors proposed to appropriate the loss of the year of EUR 21,297,574 to accumulated loss. This brings the total amount of retained losses to EUR 120,675,817.
Following the issuance of the convertible bonds on December 10th 2020, the Company paid EUR 20 million in January 2021 to the former Uteron Sellers in accordance with the terms of the renegotiated agreement with respect to the payment terms and modalities of the Company's earn-outs payment obligation.
After the close of the financial year, on February 4, 2021, the Board of Directors of the company decided to appoint Mr. Leon Van Rompay as interim CEO until further notice, for a maximum of 12 months.
On March 2, 2021, Mithra announced the commercial launch of its vaginal contraceptive ring Myring® in Italy, the fourth largest market for contraceptive rings in the world after the United States, Germany and Spain, both in terms of commercial value and volume. With two million vaginal rings sold per year, the Italian market for contraceptive rings is worth 22 million euros per year, with a stable growth of 3% per year1 . The vaginal contraceptive ring of Mithra is commercialized in Italy by the company Farmitalia under the brand Kirkos®.
On March 8, 2021, Mithra and Searchlight Pharma announced the first worldwide approval for the new combined oral contraceptive Estelle® on the Canadian market, under the brand Nextstellis®, by the regulatory agency Health Canada. This is the first and only combination oral contraceptive product (COC) based on the unique native estrogen Estetrol (E4). E4 will be the first new estrogen-based COC to be marketed in Canada in over half a century, and the only COC alternative to ethinyl estradiol-based COC pills in Canada.
On March 26, 2021, Mithra and Gedeon Richter Plc. announced that they had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for a combined oral contraceptive (COC) consisting of Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. Subject to approval by the European Commission, marketing authorization valid in all EU member states is expected by the end of the second quarter of 2021.
On April 15 2021, Mithra and Mayne Pharma Limited announced that the US Food and Drug Administration (FDA) had approved the New Drug Application (NDA) for the novel combined oral contraceptive (COC) Estelle® under the trademark Nextstellis® (15 mg Estetrol (E4)/ 3 mg drospirenone (DRSP)). Mayne Pharma anticipates the commercial launch of Estelle® by the end of June 2021.
You are requested, for Mithra Pharmaceuticals SA, in accordance with the law and the Articles of Association, to grant discharge to the Directors and the Statutory Auditor for the duties carried out by them during the financial year ending 31 December 2020.
This report will be deposited according to the legal requirements and can be consulted at the Company's address.
Liege, 19 April 2021 For the Board of Directors,
Patricia Van Dijck Van Rompay Management BVBA , Chairman ad Interim Leon Van Rompay Managing Director
We hereby certify that, to the best of our knowledge, the consolidated financial statements as of 31 December 2020, prepared in accordance with the International Financial Reporting Standards as adopted by the European Union, and the legal requirements applicable in Belgium, give a true and fair view of the assets, liabilities, financial position and loss of the Group and the undertakings included in the consolidation taken as a whole, and that the management report includes a fair review of the development and the performance of the business and the position of the Group and the undertakings included in the consolidation taken as a whole, together with a description of the principal risks and uncertainties that they face.
On behalf of the Board of Directors
Patricia Van Dijck Van Rompay Management SRL, represented by Chairman ad Interim Léon Van Rompay, Managing Director ad Interim
CMM&C SRL, represented by Christophe Maréchal, CFO
In the context of the statutory audit of the consolidated financial statements of MITHRA PHARMACEUTICALS SA ('the Company') and its subsidiaries (together referred to as 'the Group'), we hereby present our statutory auditor's report. It includes our report of the consolidated financial statements and the other legal and regulatory requirements. This report is an integrated whole and is indivisible.
We have been appointed as statutory auditor by the general meeting of 17 May 2018, following the proposal formulated by the board of directors issued upon recommendation of the Audit Committee. Our statutory auditor's mandate expires on the date of the General Meeting deliberating on the financial statements closed on 31 December 2020. We have performed the statutory audit of the consolidated financial statements of MITHRA PHARMACEUTICALS SA for 6 consecutive years.
We have performed the statutory audit of the Group's consolidated financial statements, which comprise the consolidated statement of financial position as at 31 December 2020 and the consolidated statement of profit or loss and other comprehensive income, the consolidated statement of changes in equity and the consolidated statement of cash flows for the year then ended, and notes to the consolidated financial statements, including a summary of significant accounting policies and other explanatory information, and which is characterised by a consolidated statement of financial position total of 521 985 (000) EUR and for which consolidated income statement and other comprehensive income shows a loss for the year of 92 086 (000) EUR.
In our opinion, the consolidated financial statements give a true and fair view of the Group's net equity and financial position as at 31 December 2020, as well as of its consolidated financial performance and its consolidated cash flows for the year then ended, in accordance with International Financial Reporting Standards (IFRS) as
adopted by the European Union and with the legal and regulatory requirements applicable in Belgium.
We conducted our audit in accordance with International Standards on Auditing (ISA) as applicable in Belgium. Our responsibilities under those standards are further described in the 'Statutory auditor's responsibilities for the audit of the consolidated financial statements' section in this report. We have complied with all the ethical requirements that are relevant to the audit of consolidated financial statements in Belgium, including those concerning independence.
We have obtained from the administrative body and company officials the explanations and information necessary for performing our audit.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
Key audit matters are those matters that, in our professional judgment, were of most significance in our audit of the consolidated financial statements of the current year. These matters were addressed in the context of our audit of the consolidated financial statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters.
As a result of the acquisitions of Estetra SRL and Novalon SA in 2015, the consolidated financial statements include a contingent consideration towards the previous owners. Additionally, during the second semester of 2019, an amendment to the sellers of Estetra (Uteron) agreement was signed with significant impacts. As disclosed in Note 9.17.4 of the consolidated financial statements, this contingent liability is reported at fair value in the statement of financial position.
We consider this area a key audit matter requiring high auditor's attention because of the fact that the valuation of the contingent consideration is complex, contains key judgmental areas and is strongly affected by assumptions with regards to expected future cash flows, cash position, discount rate and market conditions.
Our audit procedures included, among others, the following:
• We have analyzed and reviewed the Company's fair value calculation including the significant underlying assumptions and checked whether an adequate valuation model was applied;
• We have analyzed the consistency of the underlying data used in the valuation model and compared these with the latest Board approved business plan;
• We consulted a valuation expert in our firm to assess the methodology, clerical accuracy, and discount rates as applied;
• We have performed an assessment of the reasonableness of key assumptions, notably expected future cash flows and cash
position, probabilities applied to the different scenario's and discount rate;
• We reviewed the sensitivity analysis prepared by management to understand the effect of a change in assumptions;
• We reviewed the completeness and adequacy of the disclosures to the consolidated financial statements (Note 9.17.4).
As described in Note 9.24 to the consolidated financial statements, the Group accounts for deferred tax assets on its tax losses carried forward and on the temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the IFRS financial statements to the extent that it is probable that future taxable profits will be realized for which unused tax losses and tax credits can be used.
We consider this area a key audit matter requiring high auditor's attention because of its significance to the financial statements and the critical judgment made to assess the recoverability of the deferred tax assets.
Our audit procedures included, among others, the following:
• We have reconciled the total amount of tax losses carried forward available to the Group to supporting evidence;
• We have reviewed the taxable impact of the relevant IFRS accounting entries;
• We have challenged the judgment made by the management about taxable profits in the foreseeable future, taking into account the tax strategy of the Group;
• We have reviewed the accounting entries;
• We reviewed the completeness and adequacy of the disclosures as included in disclosures to the consolidated financial statements (Note 9.24).
The administrative body is responsible for the preparation of consolidated financial statements that give a true and fair view in accordance with the International Financial Reporting Standards (IFRS) as adopted by the European Union and with the legal and regulatory provisions applicable in Belgium, and for such internal control as the administrative body determines is necessary to enable the preparation of consolidated financial statements that are free from material misstatements, whether due to fraud or error.
In preparing the consolidated financial statements, the administrative body is responsible for assessing the Group's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the administrative body either intends to liquidate the Group or to cease operations, or has no realistic alternative but to do so.
Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue a statutory auditor's report that includes our opinion. Reasonable assurance is a high level of assurance, but it is not a guarantee that an audit conducted in accordance with ISAs will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these consolidated financial statements.
When executing our audit, we respect the legal, regulatory and normative framework applicable for the audit of the consolidated financial statements in Belgium. However, a statutory audit does not guarantee the future viability of the Group, neither the efficiency and effectiveness of the management of the Group by the administrative body. Our responsibilities regarding the continuity assumption applied by the administrative body are described below.
As part of an audit in accordance with ISAs, we exercise professional judgment and maintain professional skepticism throughout the audit. We also:
• Identify and assess the risks of material misstatement of the consolidated financial statements, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinion. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control;
• Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Group's internal control;
• Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and related disclosures made by the administrative body;
• Conclude on the appropriateness of the administrative body's use of the going concern basis of accounting and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Group's ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw
attention in our statutory auditor's report to the related disclosures in the consolidated financial statements or, if such disclosures are inadequate, to modify our opinion. Our conclusions are based on the audit evidence obtained up to the date of our statutory auditor's report. However, future events or conditions may cause the Group to cease to continue as a going concern;
• Evaluate the overall presentation, structure and content of the consolidated financial statements and whether the consolidated financial statements represent the underlying transactions and events in a manner that achieves fair presentation;
• Obtain sufficient appropriate audit evidence regarding the financial information of the entities or business activities within the Group to express an opinion on the consolidated financial statements. We are responsible for the management, the supervision and the performance of the Group audit. We assume full responsibility for the auditor's opinion.
We communicate with the Audit Committee regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control identified during the audit.
We also provide the Audit Committee with a statement that we respected the relevant ethical requirements relating to independence, and we communicate with them about all relationships and other issues which may influence our independence, and, if applicable, about the related measures to guarantee our independence.
From the matters communicated with the Audit Committee, we determine those matters that were of most significance in the audit of the consolidated financial statements of the current year, and are therefore the key audit matters. We describe these matters in our statutory auditor's report, unless law or regulation precludes public disclosure about the matter.
The administrative body is responsible for the preparation and the contents of the management report on the consolidated financial statements and for the other information included in the annual report on the consolidated financial statements.
In the context of our mission and in accordance with the Belgian standard (version revised 2020) which is complementary to the International Standards on Auditing (ISA) as applicable in Belgium, it is our responsibility to verify, in all material aspects, the management report on the consolidated financial statements and the other information included in the management report on the consolidated financial statements, as well as to report on these elements.
Aspects relating to the management report on the consolidated financial statementsand to the other information included in the annual report on the consolidated financial statements
In our opinion, after having performed specific procedures in relation to the management report, this report is consistent with the consolidated financial statements for the same financial year, and it is prepared in accordance with article 3:32 of the Code of companies and associations.
In the context of our audit of the consolidated financial statements, we are also responsible for considering, in particular based on the knowledge we have obtained during the audit, whether the management report on the consolidated financial statements (Chapter 1 Report of the Board of Directors) contains any material misstatements, i.e. any information which is inadequately disclosed or otherwise
misleading. Based on the procedures we have performed, there are no material misstatements we have to report to you. Statement concerning independence
Our audit firm and our network did not provide services which are incompatible with the statutory audit of the consolidated financial statements and our audit firm remained independent of the Group during the terms of our mandate.
The fees related to additional services which are compatible with the statutory audit as referred to in article 3:65 of the Code of companies and associations were duly itemised and valued in the notes to the consolidated financial statements.
This report is in compliance with the contents of our additional report to the Audit Committee as referred to in article 11 of regulation (EU) No 537/2014.
Battice, April 19, 2021
BDO Réviseurs d'Entreprises SCRL Statutory auditor Represented by Cédric ANTONELLI
| Year ended 31 December | |||
|---|---|---|---|
| Thousands of Euro (€) | Notes | 2020 | 2019 |
| Revenue | 9.6, 9.18 | 9,030 | 96,520 |
| Cost of sales | 9.20, 9.21 | (3,457) | (2,487) |
| Gross profit | 5,573 | 94,033 | |
| Research and development expenses | 9.20, 9.21 | (78,458) | (57,073) |
| General and administrative expenses | 9.20, 9.21 | (15,933) | (14,774) |
| Selling expenses | 9.20, 9.21 | (1,434) | (1,539) |
| Other operating income | 9.19 | 6,574 | 6,329 |
| Total operating expenses | (89,251) | (67,057) | |
| Profit/ loss) from operations | (83,678) | 26,975 | |
| Change in fair value of contingent consideration payable | 9.15, 9.17 | (18,114) | (54,728) |
| Net fair value gain/(loss) on financial assets at fair value through profit or loss |
9.17 | (4,925) | 2,763 |
| Financial income | 9.23 | 1,782 | 271 |
| Financial expenses | 9.23 | (5,987) | (6,705) |
| Loss before taxes | (110,922) | (31,424) | |
| Income taxes | 9.24 | 18,835 | 4,859 |
| Net loss for the period | (92,086) | (26,564) |
| Result for the purpose of basic loss per share, being net loss |
(92,086) | (26,564) | |
|---|---|---|---|
| Weighted average number of shares for the purpose of basic loss per share |
40,988,235 | 37,751,788 | |
| Basic loss per share (in Euro) | 9.25 | (2.25) | (0.70) |
| Diluted loss per share (in Euro) | 9.25 | (2.25) | (0.70) |
| Year ended 31 December | |||
|---|---|---|---|
| Thousands of Euro | Notes | 2020 | 2019 |
| Net loss for the period | (92,086) | (26,564) | |
| Other comprehensive income or (loss) | 3,000 | (4,962) | |
| Items that may be reclassified to profit or loss: | |||
| Currency translation differences | (66) | 111 | |
| Gains on cash flow hedges | 9.17 | 10,415 | - |
| Tax loss relating to these items | (2,576) | ||
| Items that will not be reclassified to profit or loss: | |||
| Changes in the fair value of equity investments at fair value through other comprehensive income |
9.17 | (4,772) | (5,073) |
| Total comprehensive loss for the period | (89,086) | (31,526) | |
| Attributable to | |||
| Owners of the parent | (89,086) | (31,526) | |
| Non-controlling interests | - | - | |
| TOTAL COMPREHENSIVE LOSS FOR THE PERIOD | (89,086) | (31,526) |
The accompanying notes are an integral part of these financial statements,
| As at 31 December | |||
|---|---|---|---|
| Thousands of Euro (€) | Notes | 2020 | 2019 |
| ASSETS | |||
| Property, plant and equipment | 9.8 | 29,921 | 23,502 |
| Right-of-use assets | 9.8, 9.27 | 69,572 | 70,535 |
| Goodwill | 9.9 | 5,233 | 5,233 |
| Other intangible assets | 9.7 | 89,005 | 87,490 |
| Deferred income tax assets | 9.24 | 50,905 | 34,431 |
| Contract assets | 9.17, 9.18 | 200 | 48,975 |
| Derivatives financial assets | 9.17 | 6,184 | - |
| Investment in equity securities | 9.17 | 18,088 | 22,860 |
| Other non-current assets | 9.10 | 14,401 | 13,096 |
| Non-current assets | 283,509 | 306,121 | |
| Inventories | 9.11 | 35,382 | 16,277 |
| Contract assets | 9.17, 9.18 | 51,472 | 13,242 |
| Derivatives financial assets | 9.17 | 2,881 | |
| Trade and other receivables | 9.12 | 10,052 | 12,238 |
| Other short-term deposits | 14 | 46 | |
| Cash and cash equivalents | 9.13 | 138,675 | 49,720 |
| Current assets | 238,475 | 91,522 | |
| TOTAL ASSETS | 521,985 | 397,643 | |
| As at 31 December | |||
|---|---|---|---|
| Thousands of Euro (€) | Notes | 2020 | 2019 |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Share capital | 9.14 | 31,271 | 28,649 |
| Additional paid-in-capital | 9.14 | 332,535 | 258,898 |
| Other reserves | 9.14 | 13,690 | 3,423 |
| Accumulated deficit | 7 | (219,759) | (127,673) |
| Equity attributable to equity holders | 157,737 | 163,298 | |
| Subordinated loans | 9.15 | 12,610 | 12,430 |
| Other loans | 9.15 | 111,898 | 6,626 |
| Lease liabilities | 9.15, 9.27 | 44,282 | 45,728 |
| Refundable government advances | 9.15 | 15,195 | 13,086 |
| Other financial liabilities | 9.15, 9.17 | 101,180 | 99,866 |
| Contract liabilities | 9.18 | 3,706 | 4,056 |
| Provisions | 9.28 | 266 | 607 |
| Deferred tax liabilities | 9.24 | 4,363 | 4,148 |
| Non-current liabilities | 293,500 | 186,547 | |
| Current portion of subordinated loan | 9.15 | 1,002 | 340 |
| Current portion of other loans | 9.15 | 10,475 | 6,186 |
| Current portion of lease liabilities | 9.15, 9.27 | 7,315 | 6,746 |
| Current portion of refundable government advances | 9.15 | 1,259 | 791 |
| Current portion of other financial liabilities | 9.15 | 23,424 | 6,624 |
| Trade and other payables | 9.16 | 27,272 | 27,114 |
| Current liabilities | 70,747 | 47,800 | |
| TOTAL EQUITY AND LIABILITIES | 521,985 | 397,643 |
| Thousands of Euro | Share capital |
Additional paid-in capital |
Accumulated deficit |
Share based payment reserve |
Financial assets at FVOCI and foreign currency translation reserves |
Cash flow hedge reserve |
Total equity |
|---|---|---|---|---|---|---|---|
| Notes | 9.14 | 9.14 | 9.26 | 9.14 | 9.14 | ||
| Balance as at 1 January 2019 | 27,556 | 220,956 | (101,107) | 3,551 | (62) | - | 150,893 |
| Result for the period | (26,564) | (26,564) | |||||
| Currency translation differences | 111 | 111 | |||||
| Changes in the fair value of equity investments at fair value through other comprehensive income |
(5,073) | (5,073) | |||||
| Total comprehensive loss | |||||||
| for the period | - | - | (26,564) | - | (4,962) | - | (31,526) |
| Capital increase warrants H1 2019 | 36 | 134 | 170 | ||||
| Capital increase 23 December 2019, net of transaction costs |
1,057 | 37,806 | 38,863 | ||||
| Share-based payments expense | 4,898 | 4,898 | |||||
| Balance as at 31 December 2019 | 28,649 | 258,898 | (127,673) | 8,448 | (5,024) | - | 163,298 |
| Result for the period | (92,086) | (92,086) | |||||
| Currency translation differences | (66) | (66) | |||||
| Gains on cash flow hedges | 7,838 | 7,838 | |||||
| Changes in the fair value of equity investments at fair value through other comprehensive income |
(4,772) | (4,772) | |||||
| Total comprehensive loss | |||||||
| for the period | - | - | (92,086) | - | (4,838) | 7,838 | (89,086) |
| Capital increase of 23 June 2020, net of transaction costs |
2,505 | 60,813 | 63,318 | ||||
| LDA capital increase of August 5 2020, net of transaction costs |
117 | 1,733 | 1,850 | ||||
| Value of conversion rights on convertible bonds, net of transaction costs |
11,091 | 11,091 | |||||
| Share-based payments expense | 7,267 | 7,267 | |||||
| Balance as at 31 December 2020 | 31,271 | 332,535 | (219,759) | 15,714 | (9,862) | 7,838 | 157,737 |
The accompanying notes are an integral part of these financial statements,
| As at 31 December | ||||
|---|---|---|---|---|
| Thousands of Euro | Notes | 2020 | 2019 | |
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||
| Result from operations | (83,678) | 34,974 | ||
| Adjustments for: | ||||
| Depreciation,amortization and impairment charges | 9.8, 9.9 | 9,767 | 5,777 | |
| Gain on sale of disposal group | 9,10 | - | (7,999) | |
| Tax credit | 9,10 | (1,864) | (1,360) | |
| Share-based payments | 9.26 | 7,267 | 4,898 | |
| Taxes paid | - | 359 | ||
| Upfront payment settled in shares | 9.18, 9.17 | - | (27,933) | |
| Realized foreign exchange gains/losses | 9.23, 5 | 2,769 | - | |
| Grant income | 9.19 | (2,833) | (2,555) | |
| Subtotal | (68,572) | 6,161 | ||
| Increase/(decrease) in trade payables and other liabilities | 9.16 | 521 | 11,260 | |
| (Increase)/decrease in trade receivables and other receivables | 9.12, 9,18 | 2,186 | (7,053) | |
| (Increase)/decrease in inventories | 9.11 | (19,105) | (5,282) | |
| Increase/(decrease) in contract assets | 9.18 | 4,945 | (51,912) | |
| Net cash (used in)/provided by operating activities | (80,025) | (46,826) | ||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||
| Payment for acquisition of tangible fixed assets | 9.8 | (10,645) | (11,118) | |
| Proceeds from disposal of tangible fixed assets | 9.8 | 23 | - | |
| Payment for acquisition of intangible fixed assets | 9.7 | (5,585) | (4,337) | |
| Other financial liabilities payments | 9.17 | - | (5,000) | |
| Net cash (used in)/provided by investing activities | (16,207) | (20,455) | ||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||
| Repayment of subordinated loans and others loans | 9.15 | (36,431) | (11,080) | |
| Repayment of refundable government advances | 9.15 | (927) | (766) | |
| Proceeds from subordinated and other loans | 9.15 | 35,556 | 7,008 | |
| Proceeds from refundable government advances and other grants | 9.15 | 5,835 | 8,214 | |
| Lease payments | 9.27 | (3,475) | (2,174) | |
| Interests paid | 9.23 | (3,503) | (3,321) | |
| Proceeds from issuance of shares (net of issue costs) | 9.14 | 65,731 | 170 | |
| Proceeds from issuance of convertible bonds (net of transaction costs) | 9.14, 9.17 | 122,401 | - | |
| Net cash (used in)/provided by financing activities | 185,187 | (1,949) | ||
| Net increase/(decrease) in cash & cash equivalents | 88,954 | (69,230) | ||
| Cash & cash equivalents at beginning of year | 49,720 | 118,949 | ||
| Cash and cash equivalents at end of period | 138,675 | 49,720 |
The accompanying notes are an integral part of these financial statements,
Mithra Pharmaceuticals SA (Euronext MITRA) is a Belgian biotech company dedicated to transforming Women's Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra's goal is to develop products offering better efficacy, safety and convenience, meeting women's needs throughout their life span. Its three lead development candidates are built on Mithra's unique native estrogen platform, Estetrol (E4): Estelle®, a new era in oral contraception, PeriNesta®, the first complete oral treatment for perimenopause and Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO.
The financial position and performance of the Group was particularly affected by the following events and transactions during the reporting period:
• In December 2020, the Group issued EUR 125 million in senior unsecured convertible bonds due 17 December 2025. The Bonds will be convertible into ordinary shares of the company at an initial conversion price of EUR 25.1917, representing a 25% premium above the reference price of EUR 20.1533, being the volume weighted average price of a share on Euronext Brussels from market open to the close of trading on 10 December 2020. The Bonds were issued at 100% of their principal amount and bear a coupon of 4.250% per annum, payable semi-annualy in arrear in equal instalments on 17 December and 17 June of each year, beginning on 17 June 2021. With the convertible bonds, Mithra has secured the necessary financial resources to finance its business development strategy, and to carry on its R&D expenses.
This implies a new accounting policy, convertible bond, in the financial statements.
Note : For more details about the operations during this period, please refer to 9.14 Share capital and 9.15.1 Convertible bond
• In 2020, the Group also negotiated a EUR 50 million facility with LDA capital, a EUR 20 million bank loan and successfully raised EUR 65 million via private placement, together these financing instruments further support the development of our assets. The bank loan is committed for the next 18 months and is unused at the date of the report. The LDA capital facility is committed until April 2023 and is currently available for EUR 47 million2 .
Note : For more details about the operations during this period, please refer to 9.14 Share capital and 9.26 Sharebased payments
• The Group which is reporting in a Euro functional currency environment uses derivative financial instruments (qualifiying as cash flow hedges) to manage its exposure to foreign exchange rate risks arising from operational activities. Mithra's risk management objective is to hedge the US Dollars (USD) foreign currency exposure arising from the Estelle® license and supply agreement contracted in USD between Mithra and Mayne Pharma LLC. Mithra has a transactional USD exposure of 228 million USD arising from regulatory and sales related license milestones under the Mayne Pharma agreement. This exposure is hedged with FX forwards maturing in the period 2020-2025. The derivative financial instruments are initially recorded at fair value on balance sheet and are subsequently revalued to fair value through OCI at each reporting date. Positive fair values are reported as assets, negative fair values as liabilities, and as current/non-current based on maturities of hedging contracts.
This implies a new accounting policy, new headings in the financial statements and new notes.
Note : For more details about the operations during this period, please refer to 9.3 Financial Risk Management
2 On August 5, 2020, a capital increase took place within the framework of the authorized capital, in application of the pre-described capital commitment of May 22, 2020. The capital increase took place for a total amount of EUR 3,104,869.00, EUR 116,989.58 of which was allocated to the capital and EUR 2,987,879.42 to the "share premium" account. This capital increase gave rise to the issue of 159,800 new fully paid-up shares without designation of nominal value. At the end of this transaction, the Company's capital amounted to EUR 31,270,872.40 represented by 42,714,097 shares without designation of nominal value and fully paid
Note : For more details about the operations during this period, please refer to 9.15 Financial liabilities and to 9.27 Leases
• The New Drug Application (NDA) for Estelle® has been accepted for review by the US Food and Drug Administration (FDA) and by the European Medicines Agency (EMA) in H1 2020. On March 8, 2021, Mithra and Searchlight Pharma announced the first worldwide approval for the new combined oral contraceptive Estelle® on the Canadian market. On March 26, 2021, Mithra and Gedeon Richter Plc. announced that they had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for a combined oral contraceptive (COC) consisting of Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. Subject to approval by the European Commission, marketing authorization valid in all EU member states is expected by the end of the second quarter of 2021. On April 15 2021, Mithra and Mayne Pharma Limited announced that the US Food and Drug Administration (FDA) had approved the New Drug Application (NDA) for the novel combined oral contraceptive (COC) Estelle® under the trademark Nextstellis® (15 mg Estetrol (E4)/ 3 mg drospirenone (DRSP). Mayne Pharma anticipates the commercial launch of Estelle® by the end of June 2021.
Note : For more details about the operations during this period, please refer to 9.15 Financial liabilities and to 9.9 Goodwill & IP R&D
The consolidated financial statements are presented in thousands of euro (unless stated otherwise). The consolidated financial statements for the financial year ended 31 December 2020 have been authorized for issue by the Board of Directors of 12 April 2021. The financial statements have been prepared on historical cost basis. Any exceptions to the historical cost price method are disclosed in the accounting policies described hereafter.
The financial statements have been prepared on a going concern basis and in accordance with the main accounting principles set out in this section. The Group is expecting losses in the coming years, which is inherent to the current stage of the Group's business life cycle as a biotech company. In this respect, the following underlying assumptions have been used:
The consolidated financial statements were prepared in accordance with IFRS as adopted by the European Union ("EU").
The financial statements have been prepared in accordance with the same accounting policies adopted in the Group's last annual financial statements for the year ended 31 December 2019, noting that two new accounting policies have been defined for hedge accounting under IFRS 9 and for convertible bond under IAS 32, as those matters became applicable to Mithra as from 2020.
The new standards and interpretations effective for the first time for periods beginning on (or after) 1 January 2020 do not impact the Group's consolidated financial statements.
The accounting policies have been applied consistently across the Group for the purposes of preparation of these financial statements.
When preparing the financial statements, management undertakes a number of judgments, estimates and assumptions about recognition and measurement of assets, liabilities, income and expenses. The actual results may differ from the judgments, estimates and assumptions made by management, and will seldom equal the estimated results.
The judgments, estimate and assumptions applied in the financial statements, including the key sources of estimation uncertainty, are disclosed in note 9.4, Critical accounting estimates and judgments.
During the current financial period, the Group has adopted all the new and revised Standards and Interpretations issued by the International Accounting Standards Board (IASB) and the International Financial Reporting Interpretations Committee (IFRIC) of the IASB as adopted by the European Union and effective for the accounting year starting on January 1, 2020. The Group has not applied any new IFRS requirements that are not yet effective as of December 31, 2020.
The following new Standards, Interpretations and Amendments issued by the IASB and the IFRIC as adopted by the European Union are effective for the financial period.
The Group elected not to early adopt the following new Standards, Interpretations and Amendments, which have been issued by the IASB and the IFRIC but are not yet effective as per December 31, 2020 and/or not yet adopted by the European Union as per December 31, 2020 and for which the impact might be relevant:
None of the other new standards, interpretations and amendments, which are effective for periods beginning after January 1, 2020 which have been issued by the IASB and the IFRIC but are not yet effective as per December 31, 2020 and/or not yet adopted by the European Union as per December 31, 2020, are expected to have a material effect on the Group's future financial statements.
The Group enters into derivative financial instruments to manage its exposure to foreign exchange rate risk arising from operational activities (cash flow hedges). The Group's policy is not to enter into speculative transactions, Derivative financial instruments are initially recognized at fair value and are subsequently revalued to fair value at each reporting date.
For qualifying hedge relationships, the Group documents at the inception of the transaction the relationship between hedging instruments and hedged items, as well as its risk management objective and strategy for undertaking the hedge.
The effective portion of changes in the fair value of derivative financial instruments qualifying as cash flow hedges is recognized in the cash flow hedge reserve within equity. Gains or losses relating to the ineffective portion are recognized in the income statement. Amounts deferred in equity are subsequently released to the income statement in the periods in which the hedged item impacts the income statement. However, if a committed or forecast transaction is no longer expected to occur, then the cumulative gain or loss that was reported in equity is immediately transferred to the income statement.
Changes in fair value of derivative financial instruments that do not qualify for hedge accounting are immediately recognized in the income statement.
The Group issued a Euro-denominated bond in December 2020, , convertible into a fixed number of equity instruments (conversion price of EUR 25.1917). It is deemed as a "compound instrument", comprising both a liability and an equity component:
The economic effect of issuing such an instrument is substantially the same as simultaneously issuing a debt instrument with an early settlement provision and warrants to purchase ordinary shares, or issuing a debt instrument with detachable share purchase warrants.
The liability and equity components are accounted for separately, and the liability and equity components shown separately in the statement of financial position. This treatment is commonly referred to as "split accounting". On initial recognition of a compound instrument such as a convertible bond, IAS 32 requires the issuer to:
The liability component of the convertible bond is measured first, at the fair value of a similar liability that does not have an associated equity conversion feature. The Group has also an option to redeem the bond under certains conditions (soft call option). This call meets the definition of an embedded derivative but was not accounted for as a separate derivative because the repayment price is equal to the amortized cost of the host debt instrument and therefore under one of the exceptions in IFRS 9. Indeed, it is to be considered to be 'closely related' to the debt host contract and consequently, no separate accounting is required for the call option.
In practical terms, the measurement at the fair value of a similar liability that does not have an associated equity conversion feature is done by determining the net present value of all potential contractually determined future cash flows under the instrument (principal and interest), discounted at the rate of interest applied by the market at the time of issue to instruments of comparable credit status and providing substantially the same cash flows, on the same terms, but without the conversion option. The fair value of any embedded non-equity derivative features is then determined and included in the liability component. Thereafter, the liability component is accounted for in accordance with the requirements of IFRS 9 for the measurement of financial liabilities.
The equity component is recorded as the difference between the fair value of the compound instrument (the total issue proceeds of the bond) and the liability component as determined above. The methodology of "split accounting" in IAS 32 has the effect that no gain or loss arises from the initial recognition of the separate components of the instruments.
After initial recognition, the classification of the liability and equity components of the convertible bond is not revised, for example as a result of a change in the likelihood that a conversion option will be exercised. The amount originally credited to equity is subsequently neither remeasured or reclassified to profit or loss. The effective interest rate (6.89%) shown in profit or loss for the convertible bond is equivalent to the rate that would have been paid for nonconvertible debt increased by the transaction costs, while coupon is fixed at 4.25%.. In effect, the dilution of shareholder value represented by the embedded conversion right is shown as an interest expense.
The consolidated financial statements include all the subsidiaries over which the Group has control,
Control is achieved when the investor
Iffacts and circumstances indicate thatthere are changes to one or more ofthe three elements of control listed above, the investor shall reassess whether it controls theinvestee.
Subsidiaries are fully consolidated from the date on which control is transferred to the group, They are deconsolidated from the date that control ceases.
The acquisition method of accounting is used to account for business combinations by the group (refer to note 9.2.6)
Intercompany transactions and balances, as well as unrealised gains on transactions between group companies are eliminated, Unrealised losses are also eliminated unless the transaction provides evidence of an impairment of the transferred asset,Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the group.
Any non-controlling interests in the results and equity of subsidiaries are shown separately in the consolidated statement of profit or loss, statement of comprehensive income, statement of changes in equity and statement of financial position, respectively.
Anassociate is an entity overwhichtheGrouphas significantinfluence,Significantinfluence is the powertoparticipate in the financial and operating policy decisions of the investee but is not control or joint control over thosepolicies.
A joint venture is a joint arrangement whereby the parties that have joint control of the arrangement have rights to the net asset of the joint arrangement, Joint control is the contractually agreed sharing of control of an arrangement, which exists only when decisions about the relevant activities require unanimous consent of the parties sharing control.
The results and assets and liabilities of associates or joint ventures are incorporated in these consolidated financial statements using the equity method of accounting. Under the equity method, an investment in an associate or joint venture is initially recognised at cost and adjusted for the Group's share of the profit or loss and other comprehensive income of the associate or joint venture. When the Group's share of losses of an associate or joint venture exceeds its interest in that associate or joint venture, the Group discontinues recognising its share of further losses.
An investment in an associate or joint venture is accounted for using the equity method from the date on which the investee becomes an associate or a joint venture. On acquisition of the investment, any excess of the cost of the investment over the Group's share of the net fair value of the identifiable assets and liabilities of the investee is recognized as goodwill, which is included within the carrying amount of the investment. The requirements of IAS 39 are applied to determine whether it is necessary to recognise any impairment loss with respect to the Group's investment in an associate or a joint venture. When necessary, the entire carrying amount of the investment (including goodwill) is tested for impairment in accordance with IAS 36 (Impairment of Assets), by comparing its recoverable amount with its carrying amount. Any impairment loss recognised forms part of the carrying amount of the investment. Any reversal of that impairment loss is recognised in accordance with IAS 36 to the extent that the recoverable amount of the investment subsequentlyincreases.
The Group applies the acquisition accounting method to account for business combinations. Identifiable assets acquired, and liabilities and contingent liabilities assumed, are, with limited exceptions, measured initially at their fair values at the acquisition date. The consideration transferred for the acquisition of a subsidiary is the fair value of the assets transferred, the liabilities incurred to the former owners of the acquiree and the equity interest issued by the Group. This includes the fair value of any contingent consideration. Where the consideration transferred, together with the non-controlling interest, exceeds the fair value of the net assets, liabilities and contingent liabilities acquired, the excess is recorded as goodwill. The costs of acquisition are charged to the income statement in the period inwhich they are incurred.
Where not all of the equity of a subsidiary is acquired, the non-controlling interest is recognised either at fair value or at the non-controlling interest's share of the net assets of the subsidiary, on a case-by-case basis. Changes in the Group's ownership percentage of subsidiaries are accounted for within equity.
Where settlement of any part of cash consideration is deferred, the amounts payable in the future are discounted to their present value as at the date of exchange. The discount rate used is the entity's incremental borrowing rate, being the rate at which a similar borrowing could be obtained from an independent financier under comparable terms and conditions.
Contingent consideration is classified either as equity or a financial liability. Amounts classified as a financial liability are subsequently remeasured to fair value with changes in fair value recognised in profit orloss.
If the business combination is achieved in stages, the acquisition date carrying value of the acquirer's previously held equity interest in the acquire is remeasured to fair value at the acquisition date. Any gains or losses arising from such remeasurement are recognised in profit orloss.
An operating segment is a component of anentity:
The Group's consolidated financial statements are presented in Euros, which is also the parent company's functional currency.
Foreign currency transactions are translated into the functional currency of each entity using the exchange rates prevailing at the dates of the transactions. At the end of each reporting period the entity shall (a) translate the foreign currency monetary items at closing rate, (b) translate non-monetary items measured at historical cost in a foreign currency, using the exchange rate of the transaction date, (c) translate non-monetary items measured at fair value in a foreign currency using the exchange rates at the date the fair value was determined. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the income statement within 'financial income or cost'.
On consolidation, assets and liabilities including related goodwill of components of the Group, are translated into Euros at the financial year's closing rate.. Exchange adjustments arising when translating the financial statements of foreign subsidiaries, and those arising on loans to or from a foreign operation for which settlement is neither planned nor likely to occur and which therefore form part of the net investment in the foreign operation, are recognized initially in other comprehensive income and reclassified from equity to profit or loss on disposal or partial disposal of the net investment.
Expenditure on research activities is recognised as an expense in the period in which it is incurred.
An internally generated intangible asset arising from development is recognised to the extent that all conditions for capitalisation have been satisfied as specified in IAS 38:
This recognition is conventional when a regulatory filing has been made in a major market and the approval from the regulators is considered as highly probable. Some of its products which are capitalised as from current year do not require any regulatory approval.
The amount initially recognised for internally-generated intangible assets is the sum of the expenditure incurred from the date when the intangible asset first meets the recognition criteria listed above. Where no internally-generated intangible asset can be recognised, development expenditure is recognised in profit or loss in the period in which it is incurred.
Subsequent to initial recognition, internally-generated intangible assets are reported at cost less accumulated amortisation and accumulated impairment losses, on the same basis as intangible assets that are acquired separately.
Separately acquired intangible assets are shown at historical cost. Contingent payments based on future performance are an attribute of a fair value measurement throughout the life of the asset. The contingent payments will be disclosed as a contingent liability. When the contingent liability becomes a liability the re-measurement at the end of each reporting period shall be accounted for as an adjustment to the cost of intangible assets to the extent that it relates to future benefits and reporting periods. Intellectual property rights, patents, licenses, know-how and software with a finite useful life are carried at cost less accumulated amortisation. Amortisation is calculated using the straight-line method to allocate the cost of these intangibles over their estimated useful lives of 7 to 10 years and starts at the moment the assets are available for use.
In the event an asset has an indefinite life, this fact is disclosed along with the reasons for being deemed to have an indefinite life.
Intangible assets acquired in a business combination, including in-process research and development, are initially measured as explained in paragraph9.2.6
Property, plant and equipment is carried at historical cost, less subsequent depreciation. Historical costs are capitalized and include expenditure that is directly attributable to the acquisition of the assets, expenditure for bringing the asset to the location and condition necessary for it to be capable of operating in the intended manner, including the in-house development costs.
Borrowing costs that are directly attributable to the acquisition, construction or production of a qualifying asset, here the CDMO platform, form part of the cost of that asset. Other borrowing costs are recognised as an expense. Borrowing costs are interest and other costs that Mithra CDMO incurs in connection with the borrowing of funds.
Subsequent costs are included in the asset's carrying amount or recognised as a separate asset, as appropriate, only when it is probable that future economic benefits associated with the item will flow to the Group and the cost of the item can be measured reliably. The carrying amount of the replaced part is derecognised. All other repair and maintenance expenses are charged to the profit and loss during the financial period in which they areincurred.
Land is not depreciated. Depreciation on other assets is calculated using the straight-line method to allocate their cost to their residual values over their estimated useful lives, as follows:
Specific machines are depreciated using unit of production depreciation method.
The acquisition value of the assets have been analysed by component and specific useful lives and residual values were applied to each of them. The residual value of the building is estimated to correspond to the cost of the structure of the building. An asset's carrying amount is written down immediately to its recoverable amount if the asset's carrying amount is greater than its estimated recoverableamount.
Gains and losses on disposals are determined by comparing the proceeds with the carrying amount and are recognised within 'Other operating income or expenses' in the income statement.
Assets with an indefinite useful life are tested for impairment annually and at each reporting date, and whenever there is an indication that the asset might be impaired. Assets that are subject to amortisation are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The recoverable amount is the higher of fair value less costs to sell and value in use. To determine fair value less cost to sell, the forecasted future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to theasset.
If the recoverable amount of an asset or cash-generating unit is estimated to be less than the carrying amount, the carrying amount of the asset is reduced to its recoverable amount. A cash-generating unit is the smallest identifiable Group of assets that generates cash inflows that are largely independent of the cash flows from other assets or Group of assets. An impairment loss is immediately recognised as an expense. Intangible and tangible assets other than goodwill that suffered an impairment are reviewed for possible reversal of the impairment at each reporting date. Where an impairment loss subsequently reverses, the carrying amount of the asset is increased to the revised estimate ofits recoverable amount, but so that the increased carrying amount does not exceed the carrying amount that would have been determined had no impairment loss been recognised for the asset in prior years. A reversal of an impairment loss is recognised as income. An impairment loss recognised for goodwill shall not be reversed in a subsequent period.
To qualify as discontinued operations, a component of Mithra group must have been classified as held for sale and represent a separate major line of business or is a part of a single coordinated plan to dispose of a separate major line of business.
Within 2018 and 2019 annual reports, BeLux Business within Product sales area was classified as a discontinued operation and the assets belonging to this operation were reported as held for sale. Non-current assets or disposal groups that were classified as held for sale were measured at the lower of carrying amount and fair value less cost to sell.
The inventories mainly consist of raw material, semi-finished goods and finshed goods.
Trade goods are valued at the lower of cost and net realisable value. Cost is determined using the first-in, first-out (FIFO) method. Net realisable value represents the estimated selling price less all estimated costs of completion and costs to be incurred in marketing, selling and distribution.
Write-offs are performed based on the shelf life of the products.
Regarding pre-launch inventory, we recor them once the product has attained a stage in the development process of having been subject to a market authorization application filing and has a well characterized manufacturing process. In addition, we must have an internal sales forecast that includes an assessment that sales will exceed the manufacturing costs plus the expected cost to distribute the product. Finally, product stability data must exist so that we can assert that capitalized inventory is anticipated to be sold, based on the sales projections noted above, prior to anticipated expiration of a product's shelf life. If approval for these product candidates is not received, or approval is not received timely compared to our estimates for product shelf life, we will write-off the related amounts of pre-launch inventory in the period of that determination.
Tradereceivablesare amounts due from customers for merchandise sold or services performed in the ordinary course of business and are recognized initially at fair value and subsequently measured at amortised cost using the effective interest method less allowance for expected credit losses.
Term deposits with an initial term of more than three months are held to maturity and measured at amortized cost.
Cash and cash equivalents are carried in the balance sheet at nominal value. For the purposes of the cash flow statement, cash and cash equivalents comprise cash on hand and deposits held on call with banks. In the balance sheet, bank overdrafts, if any, are included in borrowings in current liabilities.
Ordinary shares are classified as equity.
Incremental costs directly attributable to the issue of new ordinary shares or options are shown in equity as a deduction, net of tax, from the proceeds.
Equity instruments issued by the Company are recorded in the amount of the proceeds received, net of direct issue costs.
Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers.Trade payables are recognised initially at fair value and subsequently measured at amortised cost using the effective interest method.
Borrowings are recognised initially atfair value, net oftransaction costs incurred. Borrowings are subsequently carried at amortised cost; any difference between the proceeds (net of transaction costs) and the redemption value is recognised in the profit or loss over the term of the borrowings using the effective interest method.
Fees paid on the establishment of loan facilities are recognised as transaction costs of the loan to the extent that is probable that some or all of the facility will be drawn down. In this case, the fee is deferred until the draw-down occurs. To the extent there is no evidence that it is probable that some or all of the facility will be drawn down, the fee is capitalised as a pre-payment for liquidity services and amortised over the period ofthe facility to which itrelates.
The tax expense or credit for the period comprises current and deferred tax. Tax is recognised in the income statement, except to the extent that it relates to items recognised in other comprehensive income or directly in equity.
The current income tax charge is calculated on the basis of the tax laws enacted or substantively enacted at the balance sheet date in the countries where the Company and its subsidiaries operate and generate taxable income.
Management periodically evaluates positions taken in tax returns with respect to situations in which applicable tax regulation is subject to interpretation. It establishes provisions where appropriate on the basis of amounts expected to be paid to the tax authorities.
Deferred income tax is recognised, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. However, deferred tax liabilities are not recognised if they arise from the initial recognition of goodwill. Deferred income tax is not accounted for if it arises from initial recognition of an asset or liability in a transaction other than a business combination that at the time of the transaction affects neither accounting nor taxable profit or loss. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantially enacted by the balance sheet date and are expected to apply when the related deferred income tax asset is realised or the deferred income tax liability is settled.
Deferred tax assets are recognised only to the extent that it is probable that future taxable profit will be available against which the temporary differences can be utilised.
The Group leases various offices and cars.
The Group has applied IFRS 16 to all contracts in force at 1 January 2019 and previously identified as leases in accordance with IAS 17 and IFRIC 4.
Assets and liabilities arising from a lease are initially measured on a present value basis. Lease liabilities include the net present value of the following lease payments:
The lease term covers the non-cancellable period for which the Group has the right to use an underlying asset, together with both:
(a) periods covered by an option to extend the lease if the Group is reasonably certain to exercise that option; and
(b) periods covered by an option to terminate the lease if the Group is reasonably certain not to exercise that option.
The lease payments are discounted using the interest rate implicit in the lease. If that rate cannot be determined, the lessee's incremental borrowing rate is used, being the rate that the lessee would have to pay to borrow the funds necessary to obtain an asset of similar value in a similar economic environment with similar terms and conditions. Right-of-use assets are measured at cost comprising the following:
The Group measures its right-of-use assets similarly to other non-financial assets (such as property, plant and equipment) and lease liabilities similarly to other financial liabilities. Therefore, the nature of the expenses related to those leases changes as we recognize a depreciation of the right-of-use assets and an interest expense on the lease liabilities. The depreciation is done on a straight-line basis.
Payments associated with short-term leases and leases of low-value assets are recognized on a straight-line basis as an expense in profit or loss. Short-term leases are leases with a lease term of 12 months or less.
Net sales encompass revenue recognised resulting from transferring control over products sold to customers.
a) The entity (is reasonably expected to) undertakes activities that will significantly affect the IP to which the customer has rights;
b) The customer's rights to the IP expose it to the positive/negative effects of the activities that the entity undertakes in (a);
c) No goods or services are transferred to the customer as the entity undertakes the activities in (a).
3 Intellectual property
4 Research and development
consideration before the Group transfers goods or services to the customer, a contract liability is recognised when the payment is made or the payment is due (whichever is earlier). Contract liabilities are recognised as revenue when the Group performs under the contract.
Government grants are recognised as revenue on a systematic basis over the periods in which the entity recognises the related costs as expenses for which the grants are intended to compensate.
Refundable advances are accounted for as interestfree loans for which the benefit ofthe below-marketrate ofinterest is treated as a government grant. The benefit of the below-market rate of interest is measured as the difference between the initial fair value of the loan and the proceeds received. Accordingly, when estimating the liability, the Company (i) determines its best-estimate of the period during which it will benefit from the advance and (ii) determines the amount of the liability as the difference between the nominal amount of the loan and its discounted and risk-adjusted value using a market rate for a liability with similar risk profile to the Company. The liability is subsequently measured at amortised cost using the cumulative catch-up approach under which the carrying amount of the liability is adjusted to the present value of the future estimated cash flows, discounted at the liability's original effective interest rate. The resulting adjustment is recognised within profit or loss. When there is reasonable assurance thatthe Company will comply with the conditions attaching to the grant, and that the grant will be received, the benefit is accounted for in deduction of the related research and development expenses that it is intended to compensate.
Repayment of refundable advances may be forgiven in certain circumstances. The liability component of refundable advances is treated asagovernment grant andtakentoincome onlywhenthere is reasonable assurance thatthe entity will meet the terms for forgiveness of the advance.
Equity-settled share-based payments to employees and others providing similar services are measured at the fair value of the equity instruments at the grant date. Details regarding the determination of the fair value of equity-settled share- based payment transactions are set out in note 9.26.
The fair value determined at the grant date of the equity-settled share-based payments is expensed on a straightline basis over the vesting period, based on the Group's estimate of equity instruments that will eventually vest, with a corresponding increase in equity. At the end of each reporting period, the Group revises its estimate of the number of equity instruments expected to vest. The impact of the revision of the original estimates, if any, is recognised in profit or loss such that the cumulative expense reflects the revised estimate, with a corresponding adjustment to the equity- settled share-based payment reserve.
If the entity cancels or settles a grant of equity instruments during the vesting period (other than a grant cancelled by forfeiture when the vesting conditions are not satisfied), the entity accounts for the cancellation or settlement as an acceleration of vesting, and shall recognise immediately the amount that otherwise would have been recognised for services received over the remainder of the vesting period.
The Group currently does not have cash-settled share-based payment arrangements.
Regarding non employee share-based payment awards, there are measured at the fair value of the consideration received or the fair value of the equity instruments issued, whichever can be more reliably measured. The measurement date for equity-classified non employee share-based payment awards is the earlier of the date at which:
Companies that invest in research and development of new environmentally friendly products and advanced technologies can benefit from increased investment incentives or a tax credit following Belgian tax law, according to each company's choice. The tax credit may be calculated either as a one-off credit or spread over the depreciation period. Excess tax credit is carried forward, and the remaining balance after five years is refunded, which may result in a cash benefit. The tax credit applies to tangible and intangible fixed assets used for R&D of new products and technologies that do not have a negative impact on the environment (green investments), including R&D expenses capitalized under Belgian GAAP.
The tax credit should be claimed in the year in which the investment takes place.
Regarding the accounting treatment, the Group follows IAS 20 after assessing its situation carefully because the tax credit can be directly settled in cash and some conditions not related to taxes for receiving the tax credit exist. Tax credit is presented as other operating income in the Consolidated Statement of Income.
The group has elected to recognise changes in the fair value of certain investments in equity securities in Other comprehensive income (for those that are strategic investments, not held for trading). The changes are accumulated through other comprehensive income to Other reserves within equity. The group transfers amounts from this reserve to retained earnings when the relevant equity securities are derecognized.
The Group's overall risk management program focuses on the unpredictability of financial markets and seeks to minimize potential adverse effects on the Group's financial performance.
The Group's interest rate risk arises from long-term and short-term borrowings. Borrowings issued at variable rates expose the Group to cash flow interest rate risk, but the current interest rate environment in Europe is stable, with interest rates even being negative. Borrowings issued at fixed rates expose the Group to fair value interest rate risk. Group policy is to maintain the majority of its long term borrowings in fixed rate instruments. All borrowings are euro denominated.
Based on the simulations performed, the impact on post tax profit and equity of a 1% shift would not be significant.
The Group is materially exposed to both the USD and the AUD. Any future exchange rate risks that might materially expose the Group will be monitored closely. If appropriate, adequate mitigating actions will be taken.
The main part of the exposure to US dollar at year-end 2020 is related to a significant backlog of license milestones to be collected in the coming years under the US License and Supply contract signed with Mayne Pharma (227.960k USD of regulatory and sales related milestone payments). Milestone payments of 8.750k USD had already been collected at inception of the contact and immediately converted into Euros, and did no longer carry a US dollar exposure at year-end.
Since 2020, the Group uses derivative financial instruments to manage its exposure to foreign exchange rate risk arising from operational activities (cash flow hedges). Mithra's risk management objective is to hedge the USD exposure arising from the Estelle® license and supply agreement contracted in USD between Mithra and Mayne Pharma LLC. This exposure is hedged with FX forwards maturing in the period 2020-2025.The derivative financial instruments are initially recorded at fair value on balance sheet and are subsequently revalued to fair value through OCI at each reporting date. Positive fair values are reported as assets, negative fair values as liabilities, and as current/non-current based on maturities of hedging contracts.
The maturity table for the outstanding foreign currency hedges (forward sale of USD against EUR) is the following:
| Time to maturity | Hedged Amounts (kUSD) | Average Hedge Rate | ||
|---|---|---|---|---|
| - < 1 year | 67,960 | 1.173 | ||
| - 1-2 years | 80,000 | 1.18 | ||
| - 2-5 years | 80,000 | 1.24 | ||
| 227,960 | 1.206 |
If USD forward rates were to weaken by 10% against EURO compared to year-end USD forward rates used for the fair value measurement, these fair values of hedging contracts would be expected to increase from EUR 9,065k to EUR 25,426k. In case of 10% strengthening of USD forward rates against EURO, fair values would be expected to decrease to EUR -10,931k.
Example with a 10% weakening USD :
| Forward rates recalculated at 31/12/20 |
MTM's at 31/12/20 |
Fwd rates - 10% |
MTM's 10% USD weakening |
Delta |
|---|---|---|---|---|
| 1,231 | 19.852 | 1,353876 | 573.817 | - 553.965 |
| 1,229 | 27.106 | 1,352406 | 1.653.837 | - 1.626.731 |
| 1,238 | 1.741.195 | 1,361504 | 3.577.400 | - 1.836.205 |
| 1,239 | 1.092.894 | 1,363236 | 2.080.251 | - 987.357 |
| 1,252 | 2.460.933 | 1,377414 | 6.090.925 | - 3.629.992 |
| 1,270 | 1.210.681 | 1,396656 | 3.358.669 | - 2.147.988 |
| 1,291 | 1.355.563 | 1,419638 | 4.173.182 | - 2.817.619 |
| 1,317 | 1.157.193 | 1,448862 | 3.917.980 | - 2.760.787 |
| 9.065.418 | 25.426.061 | 16.360.643 |
Since June 30, 2020, EURO has strengthened significantly against the USD, with the foreign currency spot rate increasing from 1.12 to 1.23. This has caused the fair value of FX derivative hedges to increase from EUR-4 366k to EUR +9 065k at 31 December 2020. The average hedge rates are made of an FX spot element which was quoted on the trading date to which our counterparties (banks) added CVA (Credit Valuation Adjustment) and KVA (Capital Valuation Adjustment) elements. For the fair value calculations, the FX spot element and other adjustments at the year-end closing were also considered.
The US License and Supply contract was also structured with consideration received in the form of Mayne Pharma's ordinary shares. Mayne Pharma issued 4.95% of their outstanding shares to Mithra when signing the contract (a financial asset at fair value through other comprehensive income at year-end) and a further 4.65% will be issued following FDA approval (a contract asset at year-end), both percentages based on the number of shares outstanding at contract closing.
These two equity tranches represent 168.872.626 ordinary shares of Mayne Pharma which at year-end at 0.35 AUD/share on the Australian Stock Exchange (ASX) would represent AUD 58.2 million.
This Australian dollar exposure was still not hedged at year-end as the share price has continued to be very volatile and the timing for the transfer of the second tranche of shares is not yet determined. It was then complex to determine an underlying Australian dollar amount to be hedged, and to apply in consequence a net investment hedge accounting treatment (using FX forward contracts).This exposure will of course be closely monitored and a net investment strategy (potentially on part of the underlying value) might be considered in the future.
The Group is exposed to price risks since 2019. The main part of the exposure to price risks at year-end 2020 was related to a significant backlog of license milestones to be collected in the coming years under the US License and Supply contract signed with Mayne Pharma (up to 227.960k USD of regulatory and sales related).
Mithra will receive down payment and milestone fees in equity & cash of at least USD 295 million. In addition to that, a transfer price comprising fixed and variable components based on a percentage of high double-digit net sales over a 20-year period. Mithra will be issued 9.6% of Mayne's Ordinary Shares across two tranches: the first tranche of equity represents 4.95% of Mayne's total equity on issue; the second tranche will be awarded on FDA approval of the product.
This result in a price risk because the share's price is conditioned to the stock market price conditions since Mayne Pharma is quoted on the Australian Stock Exchange (ASX).
Credit risk relates to the risk that a counterparty will fail to fulfil their contractual obligations with the result that the Group would suffer a loss. The Group's policy focuses on only working with creditworthy counterparties and, where necessary, requiring adequate securities. Information about the creditworthiness of counterparties is provided by independent rating agencies and, if this is not available, the Group uses information that is publicly available as well as its own internal records. Credit risk is managed by the financial department of the parent company by means of individual follow-up of credit per counterparty.
An aging analysis of the debtor is also evaluated on a regular basis for potential doubtful debts. An analysis of trade receivables at 31 December 2020 and 31 December 2019 is shown below.
| Thousands of Euro (€) Past due but not impaired |
||||||
|---|---|---|---|---|---|---|
| Year | Carrying amount |
Neither impaired nor past due |
0-60 days |
61-90 days |
91-120 days |
>120 days |
| 2020 | 6,735 | 6,096 | 450 | 122 | 15 | 52 |
| 2019 | 8,011 | 4,403 | 2,296 | 700 | 70 | 542 |
IFRS 9 requires the Group to recognise a loss allowance for expected credit losses on trade receivables and contract assets. In particular, the Group applies the simplified approach to providing for expected credit losses prescribed by IFRS 9, which permits the use of the lifetime expected loss allowance for all trade receivables. The Group allows an average debtor's payment period of 30 days after invoice date. To measure the expected credit losses, trade receivables have been grouped based on shared credit risk characteristics and the days past due. In assessing the credit risk characteristics, the group takes into account any indicators of impairment up until the reporting date, and it apply a definition of default that is consistent with the definition used for internal credit risk management purposes and consider qualitative factors where appropriate. Given the current nature of trade receivables, the loss allowance provision as at year-end is zero.
It is management's opinion that at the above reporting dates no further provision for doubtful debts was required.
The above table shows the analysis of trade receivables out of contract assets, which are neither impaired nor past due.
The overall collectability risk for the remaining debt can be considered as immaterial as per management's computation following IFRS 9.
The credit risk on cash investments or cash available on banks accounts is limited given that the counterparties are banks with high credit scores attributed by international rating agencies. The financial institutions have credit ratings varying from A to AA- (upper-medium grade) and are thus considered as low credit risk.
Thanks to the successful IPO, subsequent capital increases, convertible bond, the capital commitment line with LDA Capital Limited for up to EUR 50 million (EUR 3.1 million drawn down to date), and a committed bank loan of EUR 20 million until June 2022 (fully undrawn), the Group maintains sufficient cash to finance its business development strategy, and to carry on its R&D expenses. Managementreviews cash flow forecasts on a regular basis to determine whether the Group has sufficient cash reserves to meet future working capital requirements and to take advantage of businessopportunities.
The liquidity risk mainly relates to non-current borrowings. The non-current debts primarily relate to contingent and deferred consideration payable in relation to historical acquisitions. We referto section 9.5. on business combinations from the Annual Report 2017 which describes the timing and conditions linked to these liabilities.
The maturity analysis of non-derivative financial liabilities is shown below.
| Thousands of Euro (€) |
Less than 3 months |
Between 3 months and 1 year |
Between 1 and 2 years |
Between 2 and 5 years |
Over 5 years |
Total |
|---|---|---|---|---|---|---|
| At 31 December 2020 | 55,939 | 19,118 | 41,565 | 253,415 | 184,510 | 554,548 |
| Subordinated loans & bank loans | 5,056 | 7,084 | 8,075 | 148,140 | 12,356 | 180,711 |
| Finance lease liabilities | 3,611 | 5,662 | 7,201 | 18,911 | 28,113 | 63,499 |
| Contingent consideration payable & refundable government advances |
20,000 | 6,373 | 26,289 | 86,364 | 144,041 | 283,066 |
| Trade and other payables | 27,272 | - | - | - | - | 27,272 |
| At 31 December 2019 | 33,715 | 29,490 | 36,402 | 119,048 | 188,332 | 406,987 |
| Subordinated loans & bank loans | 4,457 | 1,925 | 2,838 | 7,545 | 14,018 | 30,783 |
| Finance lease liabilities | 2,144 | 5,732 | 6,228 | 18,684 | 24,967 | 57,755 |
| Contingent consideration payable & refundable government advances |
0 | 21,833 | 27,336 | 92,819 | 149,347 | 291,335 |
| Trade and other payables | 27,114 | - | - | - | - | 27,114 |
In December 2020, the Group has completed a placement of EUR 125 million senior unsecured convertible bonds due 17 December 2025. The annual coupon of 4.250% is included in the table above.
The contingent consideration for Estetra has been included in the table above at year-end 2019 for the remaining cash payments of 210 million knowing that there is still uncertainty about the payment period given the evolution of the group's cash position, except for 20 million paid in 2021. The difference between the above table and the amounts detailed in sections 9.15. Financial liabilities and 9.17. Financial instruments are due to the fact that the amounts above are undiscounted meaning that no discount rate neither probabilities of success of research nor commercialisation have been applied to them.
Moreover, we computed the variable part of the refundable government advances and contingent consideration payable based on the existing business plan at 31 December 2020. The fixed part of the refundable government advances is of course independent of these assumptions.
For more details on borrowings and other financial liabilities, refer to notes 9.15. (Financial liabilities) and 9.17. (Financial instruments). As the amounts included in the maturity tables are the contractual undiscounted cash flows, including principal and interest payments, these amounts will not reconcile to the amounts disclosed in the balance sheet.
The Group's objectives when managing capital are to safeguard the Group's ability to continue as a going concern in order to be in a position to provide returns for shareholders in the future and benefits for other stakeholders and to obtain over time an optimal capital structure to reduce the cost of capital.
The Group makes the necessary adjustments in the light of changes in the economic circumstances, risks associated to the different assets and the projected cash needs of the current and projected research activities. The current cash situation and the anticipated cash burn / generation are the most important parameters in assessing the capital structure. The Company objective is to maintain the capital structure at a level to be able to finance its activities for at least twelve months. Cash income from new partnerships is taken into account and, if needed and possible, the Company can issue new shares or enter into financing agreements.
The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying the Group's accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosedbelow.
The financial statements have been prepared on a going concern basis and in accordance with the main accounting principles set out above.
End of 2020, Mithra has a total of EUR 219.8 million accumulated losses on its balance sheet and realized a consolidated net loss of EUR 92.1 million for the year ended 31 December 2020. The Board of Directors has analyzed the financial statements and accounting policies and based on conservative assumptions, the current cash position of EUR 138.7 million at 31 December 2020 will allow the Group to keep up with operating expenses and capital expenditure requirements at least until the end of 2021.
Based on their assessment, the Management and Board of Directors consider it appropriate to prepare the financial statements on a going concern basis. The assessment is based on expected R&D clinical results and further business deals as well as on the monitoring of our funding activities.
The uncertainly raised by the COVID-19 pandemic is not impacting going concern. Although there are lot of uncertainties, it does not impact the Company's ability to continue operations during the next twelve months.
Revenue from license granting contracts should be accounted for based on the substance of the agreements between the entity and its business partners. IFRS 15 requires management to exercise its judgment, notably in the following key areas:
Management makes its judgments taking into account all information available about the clinical status of the underlying projects at the reporting date and the legal analysis of the contracts performed by its legal counsel. Please refer to 9.18 Revenue.
R&D capitalisation involves a great deal of judgment linked to evaluating whether all conditions to capitalized development costs have been met. The judgment relates mainly to criteria such as the technical feasibility of a project and the economic benefits that will result from the project. This analysis is done on a project basis and with the involvement of internal project managers. Please refer to 9.7 Other intangible assets.Estimated impairment
The Group tests annually whether goodwill and indefinite useful life intangible assets have suffered any impairment, in accordance with the accounting policy stated in note 9.2.11. This involves the identification of potential impairment indicators and the use of significant assumptions including future cash flows, discount rate and probabilities of success. These estimates are performed taking into account all information available about the clinical status of the underlying project, some external benchmarks and the relevant market economic conditions at reporting date. Please refer to note 9.7. Other Intangible Assets and 9.9 Goodwill & IP R&D for the impairment testing performed for those assets.
Significant judgment is required in determining the tax income or expense. The Group is subject to income taxes in different jurisdictions and there are many transactions and calculations for which the ultimate tax determination is uncertain during the ordinary course of business. Measurement of the deferred tax asset related to the tax loss carryforward involves significant judgement, notably related to the foreseeable future taxable profits. We refer to section 9.24 Income tax.
Significant judgement is required in the estimation of present obligations that arise from past events including legal claims and other items. These judgments are based on the Group's prior experiences and are the best estimate of the Group's liability for these issues.
An estimation of the residual values and useful life of tangible assets and intangible assets is required to be made at least annually. Judgement is required in estimating the useful life of fixed asset categories. The residual value is the best estimate of the amount that would be obtained from the disposal of the asset, after deducting the estimated
costs of disposal, if the asset was already of the age and in the condition expected at the end of its useful life. Both residual value and useful life of tangible assets are determined based upon discussions with local engineers. Please refer to note 9.7 Other Intangible Assets and 9.9 Goodwill & IP R&D.
Monetary contingent consideration that the acquirer is due to pay or receive is within the scope of IFRS 9.
Valuation methods, usually discounted cash flow analysis, are used to determine the fair value of some of the Company's liabilities that are not traded in an active market. These valuation methods require judgement; the main assumptions and variables used are future cash flows per projects, likelihood of approval (LOA), discount rate and long-term growth rate. These assumptions are based on external benchmarks, management's estimates based on experience of the entity and on internal analysis.
Also, as from 2019, the fair value measurement of contingent consideration receivable is considered to be a significant estimate. In this respect, the expected value method is applied, based on probability weighted amounts within several possible scenarios. This valuation methodology requires judgments about the different possible scenarios and their respective probability, as well as about the discount rate applied to the expected cash flows. Please refer to note 9.17.4 Financial Assets and Liabilities accounted for at fair value. Measurement of refundable cash advances
The remeasurement of refundable cash advances using the cumulative catch up method requires periodic reestimation of the contractual cash flows required to repay the liability towards the Walloon Region. Management revise periodically the business plan of each products concerned and the probability of success of related clinical trials. Please refer to note 9.15.2 Refundable government advances.
Management judgment is required in the estimation about the fulfilment of the effectiveness requirements for an arrangement to qualify for hedge accounting. For qualifying hedge relationships, the Group documents at the inception of the transaction the relationship between the hedging instruments and the hedged transactions, as well as its risk management objective and strategy for undertaking the hedge.
The effective portion of changes in the fair value of derivative financial instruments qualifying as cash flow hedges are deferred to equity, while gains or losses relating to the ineffective portion are recognized in the income statement. Please refer to note 9.17.4 Financial Assets and Liabilities accounted for at fair value.
During 2020, Mithra had no business combinations or asset deals to account for in its year-end financial statements.
The Group has identified three reportable segments of its business : Product sales for the sales related to Mithra's complex therapeutic products (Myring® and E4 products in the future) and the remaining portfolio of generic products for the Belux business, Out-licensing business for partnership deals and Others for the R&D services rendered to third parties. Hence, a distinction is being made in the information provided regularly to the chief operating decision maker, being the Chief Executive Officer.
| Total Revenues | 9,030 | 96,520 |
|---|---|---|
| Other | 0 | 1,268 |
| Out-licensing | 5,446 | 91,645 |
| Product Sales | 3,582 | 3,607 |
| Thousands of Euro (€) | 2020 | 2019 |
For more details on the Product sales and out-licensing fees and geographical sales, please refer to section 9.19. Revenue and other operating income.
In 2020, one major customer representing 33% (Gedeon Richter Plc.) of total revenue has been identified in the "outlicensing" segment. No other customer represented more than 10% of total revenue.
The main non-current assets are located in Belgium, because in 2019 we repatriated in Belgium the intellectual property rights (relating to Estetrol, excluding the rights related to Estelle®) located in the Netherlands. Some minor assets are located in Luxemburg.
| Thousands of Euro (€) | Operating license |
Intellectual property rights |
Software licences |
R&D Expenses | Total |
|---|---|---|---|---|---|
| Costs | |||||
| At 31 December 2018 | 3,471 | 77,406 | 1,298 | 3,105 | 85,280 |
| Additions | - | 1,000 | 536 | 4,522 | 6,058 |
| Disposals | - | - | - | - | - |
| At 31 December 2019 | 3,471 | 78,406 | 1,834 | 7,627 | 91,336 |
| Additions | - | - | 791 | 4,794 | 5,586 |
| Disposals | - | - | - | - | - |
| At 31 December 2020 | 3,471 | 78,406 | 2,625 | 12,421 | 96,923 |
| Accumulated amortisation | |||||
| At 31 December 2018 | 3,034 | - | 339 | - | 3,373 |
| Amortisation expense | 131 | - | 158 | 186 | 474 |
| At 31 December 2019 | 3,165 | - | 497 | 186 | 3,848 |
| Amortisation expense and impairment |
96 | 3,450 | 325 | 199 | 4,070 |
| At 31 December 2020 | 3,261 | 3,450 | 822 | 385 | 7,918 |
| Net Book Value | |||||
| At 31 December 2018 | 436 | 77,406 | 959 | 3,105 | 81,905 |
| Cost | 3,471 | 78,406 | 1,834 | 7,627 | 91,337 |
| Accumulated amortisation and impairment |
3,165 | - | 497 | 186 | 3,847 |
| At 31 December 2019 | 305 | 78,406 | 1,337 | 7,441 | 87,490 |
| Cost | 3,471 | 78,406 | 2,625 | 12,421 | 96,923 |
| Accumulated amortisation and impairment |
3,261 | 3,450 | 822 | 385 | 7,918 |
| At 31 December 2020 | 209 | 74,956 | 1,804 | 12,036 | 89,005 |
Other intangible assets consist mainly of a portfolio of acquired product rights, market access rights and internally generated intangible assets.
The rights were acquired from 1999 until present from different pharmaceutical companies.
The Donesta® intangible asset were acquired for an initial payment plus agreed additional payments contingent on future performance. The accounting for contingent consideration of these assets was not considered on initial recognition of the asset, but will be added to the cost of the asset when incurred (the cost accumulation model).
Over 2020, EUR 4,794k has been added to the Other intangible assets as a result of a capitalization of development costs related to the project "E4 synthesis" and the project Estelle® since the filing of the application for market authorization that occurred in the first semester. Those additions are offset by impairment charges on license rights acquired from GSP (EUR 3,450k).
Most of IP rights and internally generated assets are not yet amortised because they are not yet available for use. MyRing intellectual property rights is also considered as not fully available for use. Indeed, major market targeted for this product is USA. Few product sales occurred in 2020 since product launch in some countries in Europe. During the period of development, the assets are tested for impairment. No impairments indicators have been identified on Intangible assets, except for license rights acquired from GSP (EUR 3,450k) fully impaired in 2020. Those products purchased had no further added value within Mithra's development strategy.
| Thousands of Euro (€) | 2020 | 2019 | Clinical Status |
|---|---|---|---|
| Intangible Estelle | 30,686 | 30,686 | Application for market authorization filed |
| Donesta asset deal | 8,000 | 8,000 | Phase III ongoing |
| Intangible Zoreline | 24,382 | 24,382 | PK study |
| Intangible MyRing | 11,425 | 11,425 | UE : commercialized US : application for market authorization filed |
| Products purchased GSP | - | 3,450 | Fully impaired |
| Others | 463 | 463 | N/A |
| Total | 74,956 | 78,406 | - |
| Property, Plant and equipment | Right-of-use assets (9.27) |
||||
|---|---|---|---|---|---|
| Thousands of Euro (€) | Land and buildings |
Fixtures and equipment |
Motor Vehicles |
Leasing | Total |
| Cost | |||||
| At 31 December 2018 | 2,217 | 16,403 | 117 | 71,175 | 89,912 |
| Additions | 558 | 9,127 | - | 4,990 | 14,675 |
| Disposals | - | - | (6) | - | (6) |
| At 31 December 2019 | 2,775 | 25,530 | 111 | 76,165 | 104,581 |
| Additions | 542 | 8,437 | - | 2,549 | 11,528 |
| Disposals | - | (5) | (17) | (12) | (35) |
| At 31 December 2020 | 3,317 | 33,962 | 94 | 78,703 | 116,075 |
| Accumulated depreciation | |||||
| At 31 December 2018 | 687 | 2,129 | 89 | 2,621 | 5,526 |
| Amortisation expense | 142 | 1,871 | (4) | 3,009 | 5,018 |
| At 31 December 2019 | 829 | 4,000 | 85 | 5,630 | 10,544 |
| Amortisation expense | 222 | 2,322 | (7) | 3,501 | 6,038 |
| At 31 December 2020 | 1,051 | 6,322 | 78 | 9,131 | 16,582 |
| Net Book Value | |||||
| At 31 December 2018 | 1,530 | 14,274 | 28 | 68,557 | 84,387 |
| Cost | 2,775 | 25,530 | 111 | 76,165 | 104,581 |
| Accumulated amortisation and impairment |
829 | 4,000 | 85 | 5,630 | 10,544 |
| At 31 December 2019 | 1,946 | 21,530 | 26 | 70,536 | 94,037 |
| Cost | 3,317 | 33,962 | 94 | 78,703 | 116,075 |
| Accumulated amortisation and impairment |
1,051 | 6,322 | 78 | 9,131 | 16,582 |
| At 31 December 2020 | 2,266 | 27,639 | 16 | 69,572 | 99,493 |
Tangible fixed assets (Property, plant and equipment and the Right-of-use assets) increased EUR 5,456k, mainly relating to machinery and equipment in the new production facility (Myring® equipment) for the manufacturing of pharmaceuticals products (Mithra CDMO) and their related development costs for machine settings and improvement.
For more details about the right-of-use assets, please refer to financial note 9.27. Leases.
Goodwill results entirely from the acquisition of Estetra (EUR 3,814k) and Novalon (EUR 1,420k).
Goodwill are allocated to CGU's that are tested for impairment5 at least annually. In the year of acquisition of Estetra and Novalon, management confirmed the validity of the expected cash flow approach used when acquiring the businesses, breaking down the risks and using all expectations about possible cash flows and discounting the expected value at a rate of 12,48% ignoring risks for which the estimates of future cash flows have already been adjusted.
5 The uncertainly raised by the COVID-19 pandemic is not impacting impairment testing. Although there are lots of uncertainties, it does not impact the Group's assets valuation as of December 31, 2020.
Regarding the recoverable value of Estelle®, no impairment loss was identified due to an increase in probability to reach market authorisation (from 38% to 90%) and obtaining contracts outside of Europe and the USA, The same applies for Donesta® and the Novalon products.
More specifically, the assets related to Estetra and Novalon products are tested for impairment in groups of assets described as three different cash-generating units (CGUs), being Estelle®, Myring® and Zoreline®.
| Thousands of Euro (€) | 2020 |
|---|---|
| CGU value Estelle | 34,500 |
| CGU value Zoreline | 25,376 |
| CGU value Myring | 11,851 |
| Total | 71,727 |
For the reconciliation with the total amount of IP R&D please refer to note 9.7, "Other intangible assets".
The recoverable amounts are based on the fair value less cost to sell methodology which use some risk-adjusted discounted cash flow models for a period of 10 years. If any terminal value is included, further cash flows are extrapolated using a negative long term growth rate. Probabilities of success are also different by CGU and are updated based on latest information about clinical results; The discount rate applied was updated following the specific product covered by the IP rights; Each model/product has its own WACC in 2020. Management's assessment is that the recoverable amounts exceeds their carrying value and that no impairment is required.
| Probability of sucess in 2020 | |||||
|---|---|---|---|---|---|
| Intangible assets tested | Long term growth rate |
Phase 2 | Phase 3 | WACC | |
| Estelle® | -1% | 100% | 90% | 11,72% | |
| Long term growth rate |
R&D | Commercial | WACC | ||
| Zoreline® | -3% | 80% | 55% | 14,80% | |
| Myring® | 0% | 90% | 75% | 13,09% |
| Probability of sucess in 2019 | ||||
|---|---|---|---|---|
| Intangible assets tested | Long term growth rate |
Phase 2 | Phase 3 | WACC |
| Estelle® | -1% | 100% | 78% | 11,50% |
| Long term growth rate |
R&D | Commercial | WACC | |
| Zoreline® | -3% | 80% | 55% | 14,70% |
| Myring® | 0% | 90% | 75% | 12,80% |
A sensitivity analysis has been performed on the impairment testing. Mithra performed the sensitivity test by increasing the discount rate by 1 percentage point. This did not result in any impairment losses. A reasonable change in the assumptions relating to the probability of success on Estelle® and Myring® would have no impact. For Zoreline®, with Pos of 80% (R&D) and 55% (commercial), a drop in the cumulative probability (R&D / commercial) from 67.5% to 59% does not change the test conclusions.
| As at 31 December | ||
|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 |
| R&D tax credit receivable | 5,628 | 3,764 |
| Advance payments | 550 | 1,100 |
| Other long term receivables | 224 | 233 |
| Contingent consideration receivable | 7,999 | 7,999 |
| Total other non-current assets | 14,401 | 13,096 |
In 2020, we can notice a slight increase of Other non-current assets mainly explained by increase of the R&D tax credit receivable which is tax incentive for R&D investments that have no impact or reduce the impact on the environment (please refer to Note 9.19).
| As at 31 December | |||
|---|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 | |
| Raw materials & consumables | 32,442 | 15,110 | |
| Semi-finished goods | 2,915 | - | |
| Finished goods | 25 | 1,317 | |
| Total at cost | 35,382 | 16,427 | |
| Cumulated amounts written off at the beginning of the period |
-150 | -367 | |
| Reversal of write-down of inventories credited to expense in the period |
150 | 217 | |
| Cumulated amounts written off at the end of the period | 0 | -150 | |
| Total net carrying amount | 35,382 | 16,277 |
Inventories increased to EUR 35,382k from EUR 16,277k in 2019, in the context of Estelle® commercial launch preparation.
| As at 31 December | ||
|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 |
| Trade receivables | 5,287 | 9,191 |
| Recoverable VAT | 2,389 | 2,049 |
| Prepayments | 1,568 | - |
| Other | 809 | 998 |
| Total trade receivables and other current assets | 10,053 | 12,238 |
The decrease of trade receivables and other current assets is mainly driven by the decrease in trade receivables due to lower out-licensing revenue.
Prepayments as of December 31, 2020 relate to advance payments to ICON for Donesta Phase III and Sequens for E4 synthesis.
| Total cash and cash equivalents | 138,675 | 49,720 |
|---|---|---|
| Cash at bank and in hand | 138,675 | 49,720 |
| Thousands of Euro (€) | 2020 | 2019 |
| As at 31 December |
At 31 December 2020 and 31 December 2019, the Company's share capital was represented by the following number of shares (units), all fully paid up and without nominal value:
| As at 31 December | ||
|---|---|---|
| 2020 | 2019 | |
| Number of shares (issued and fully paid) | 42,714,097 | 39,133,245 |
There are no share categories within the company; i.e. all shares have the same voting rights. There were no treasury shares at the end of December 2020.
Some shares are reserved for issuance under options, which are warrants to be exercised respectively as from 1st January 2019, as from 6th November 2020 and from 29 January 2021. Refer to note 9.26 Share-based payments..
The change in the number of shares for the years 2019 and 2020 is summarized in the below table:
| Thousands of Euro (€) | Number of Shares |
Issued Capital |
Additional paid in capital |
Total |
|---|---|---|---|---|
| Balance at 31 December 2018 | 37,639,495 | 27,556 | 220,956 | 248,512 |
| - Capital increase | 1,444,250 | 1,057 | 37,806 | 38,863 |
| - Capital increase by susbscription rights | 49,500 | 36 | 134 | 170 |
| Balance at 31 December 2019 | 39,133,245 | 28,649 | 258,898 | 287,547 |
| - Capital increases | 3,580,852 | 2,622 | 62,546 | 65,168 |
| - Value of conversion rights on convertibles bonds | - | - | 11,091 | 11,091 |
| Balance at 31 December 2020 | 42,714,097 | 31,271 | 332,535 | 363,806 |
The following capital transactions took place within Mithra took place during the course of the year 2020:
• On May 22, 2020, a capital commitment was made as part of the authorized capital for a maximum amount of EUR fifty million (50,000,000) (including the share premium) by the issue of a number of new shares at an issue price still to be determined at the time of the transaction. This capital increase is subject to the condition precedent of the effective completion of the new shares' subscription for the benefit of LDA Capital Limited, a company with which the Company entered into a capital commitment agreement on April 23, 2020. Under the terms of this agreement, LDA Capital agreed to commit an amount of up to EUR fifty million (50,000,000) (the "Capital Commitment") in cash within a maximum of three years in exchange for new ordinary shares in Mithra. This Capital Commitment will be released based on drawdowns by Mithra in the form of put options that Mithra has the right to exercise at its sole discretion. The number of shares will be dependent upon certain parameters such as Mithra's trading volume during the previous 15-day period and the price per share during the forward-looking 30-day pricing period. The striking price of the put option is determined by the volume weighted average price (VWAP) of Mithra's shares during such 30-day pricing period. The minimum issue price of the new shares shall not be less than EUR 19.50 (subject to the adjustment mechanism provided for in the Put Option Agreement. At the end of this operation, LDA Capital Limited may not hold more than 4.9% of the outstanding ordinary shares of Mithra.
The group has elected to recognise changes in the fair value of certain investments in equity securities in Other comprehensive income, as explained in note 9.17 under Financial instruments. These changes are accumulated through other comprehensive income within Financial assets at FVOCI reserve within equity. The group transfers amounts from this reserve to retained earnings when the relevant equity securities are derecognized.
Other reserves also contain cumulative foreign currency adjustment arising from the translation of the financial statements of our Brasilian subsidiary.
As at December 31, 2020, the Other reserves (EUR -9,862k) contains cumulative translation adjustments coming from the foreign subsidiaries (EUR -17k) and the cumulative changes in fair value of financial assets through other comprehensive income within financial assets at FVOCI and foreign currency translation reserves (EUR -9,845k).
The Group entered into derivative financial instruments to manage its exposure to foreign exchange rate risk arising from operational activities (cash flow hedges). The effective portion of changes in the fair value of derivative financial instruments qualifying as cash flow hedges is deferred to equity. Amounts deferred in equity are subsequently released to the income statement in the periods in which the hedged transaction impacts the income statement.
As of December 31, 2020, the cash flow hedge reserve (EUR 7,838k) contain the cumulative changes in fair value of hedging instruments. Please refer to note 9.3 Financial Risk Management.
An overview of the borrowings is shown below.
| As at 31 December | ||||||
|---|---|---|---|---|---|---|
| 2020 | 2019 | |||||
| Thousands of Euro (€) | Total | Current | Non-Current | Total | Current | Non-Current |
| Subordinated loans | 13,612 | 1,002 | 12,610 | 12,770 | 340 | 12,430 |
| Other loans | 122,373 | 10,475 | 111,898 | 12,812 | 6,186 | 6,626 |
| Bank loans | 10,713 | 5,162 | 5,551 | 12,392 | 6,186 | 6,206 |
| Convertible bonds | 111,310 | 5,313 | 105,997 | - | - | - |
| Capital grants | 350 | 0 | 350 | 420 | - | 420 |
| Lease liabilities | 51,597 | 7,315 | 44,282 | 52,474 | 6,746 | 45,728 |
| Refundable government advances | 16,454 | 1,259 | 15,195 | 13,877 | 791 | 13,086 |
| Sub-total liabilities arising from financing activities |
204,036 | 20,051 | 183,985 | 91,933 | 14,063 | 77,870 |
| Other financial liabilties | 124,604 | 23,424 | 101,180 | 106,490 | 6,624 | 99,866 |
| Total financial liabilities | 328,640 | 43,475 | 285,165 | 198,413 | 20,687 | 177,736 |
Reconciliation of liabilities arising from financing activities in 2020:
| Non-cash | ||||||||
|---|---|---|---|---|---|---|---|---|
| Thousands of Euro (€) | 2019 | Cash flows | changes | 2020 | ||||
| Inflow | Outflow | Addi tions |
Classification of part of the proceeds in equity |
Classification of part of the proceeds in grant income |
Amortized costs adjustments |
|||
| Unsecured subordinated loans |
208 | (62) | 146 | |||||
| Secured subordinated loans |
12,561 | 1,239 | (333) | 13,467 | ||||
| Straight loan | 5,083 | 34,168 | (35,243) | 4,000 | ||||
| Innodem | 2,274 | (57) | 2,217 | |||||
| Convertible bond | 0 | 122,401 | (11,091) | 111,310 | ||||
| Other bank loans | 5,035 | 215 | (754) | 4,496 | ||||
| Lease liabilities | 52,474 | - | (3,475) | 2,598 | 51,597 | |||
| Capital grants | 420 | (70) | 350 | |||||
| Refundable government advances |
13,877 | 2,752 | (927) | (581) | 1,334 | 16,454 | ||
| Total | 91,933 | 160,775 | (40,851) | 2,598 | (11,091) | (581) | 1,265 | 204,036 |
Reconciliation of liabilities arising from financing activities in 2019:
| Thousands of Euro (€) |
2018 | Cash flows | Non-cash changes |
2019 | ||
|---|---|---|---|---|---|---|
| Inflow | Outflow | Additions | Amortized costs adjustments |
|||
| Unsecured subordinated loans | 293 | (85) | 208 | |||
| Secured subordinated loans | 14,102 | 108 | (1,362) | (287) | 12,561 | |
| Straight loan | 9,754 | 4,000 | (8,671) | 5,083 | ||
| Innodem | 2,618 | (344) | 2,274 | |||
| Other bank loans | 2,595 | 2,900 | (460) | 5,035 | ||
| Lease liabilities | 50,141 | (2,174) | 4,507 | 52,474 | ||
| Capital grants | 446 | (26) | 420 | |||
| Refundable government advances | 10,921 | 3,114 | (766) | 609 | 13,877 | |
| Total | 90,869 | 10,122 | (13,862) | 4,507 | 296 | 91,933 |
Below we present the characteristics of the (9.15.1) subordinated loans, the other loans and the lease liabilities, the (9.15.2) refundable government advances, and (9.15.3) other financial liabilities.
The detailed breakdown and the characteristics of the subordinated loans, the other loans and the lease liabilities as follows:
| Thousands of Euro (€) | Interest rate % | Fixed / Variable |
Maturity | 2020 | 2019 |
|---|---|---|---|---|---|
| NON-CURRENT | |||||
| Subordinated loans (non-current) | 12,610 | 12,430 | |||
| Unsecured subordinated loans | 62 | 125 | |||
| Development Brazilian/Dutch subsidiary | 4.95% | Fixed | 2022 | 62 | 125 |
| Secured subordinated loans | 12,548 | 12,305 | |||
| CDMO Phase 1 | 4.00% | Fixed | 2035 | 8,214 | 8,214 |
| CDMO Phase 2 | 4.00% | Fixed | 2034 | 4,334 | 4,091 |
| Other loans (non-current) | 111,548 | 6,207 | |||
| Investment loans | 2.00% | Fixed | 2023 | 222 | 332 |
| Working capital funding | 5.24% | Fixed | 2023 | 137 | 213 |
| Convetible bond | 6 6.89% |
Fixed | 2025 | 105,997 | 0 |
| Belfius | 1.89% | Fixed | 2027 | 3,163 | 3,738 |
| CBC Covid | 1.50% | Fixed | 2024 | 162 | 0 |
| Innodem | 2.57% | Fixed | 2026 | 1,867 | 1,924 |
| Lease liabilities (non-current) | 44,282 | 45,728 | |||
| Leasing "Intégrale" (Immo Phase I) | 5.40% | Fixed | 2032 | 21,568 | 22,772 |
| Leasing « Intégrale » (Immo Phase II) | 5.75% | Fixed | 2034 | 8,033 | 8,389 |
| Leasing ING Lease (solar panels) | 3.00% | Fixed | 2026 | 259 | 307 |
| Leasing CBC Lease | 2.00% | Fixed | 2021 | 314 | 818 |
| Dettes ING Lease | 0.745% | Variable | 2026 | 2,551 | 521 |
| Leasing ING Lease (Phase 2) | 3.00% | Fixed | 2026 | 5,673 | 6,207 |
| Leasing ING Lease (Phase I) | 3.14% | Fixed | 2026 | 5,483 | 6,146 |
| Other lease liabilities | 1.33%-1.44% | Fixed | Variable | 402 | 569 |
| Total non-current | 168,440 | 64,366 |
6 6,89% is the effective interest rate, so including the conversion into interest expense of the embedded conversion right and the transaction costs, while the coupon of the bonds is fixed at 4.25%
| Thousands of Euro (€) | Interest rate % | Fixed / Variable |
Maturity | 2020 | 2019 |
|---|---|---|---|---|---|
| CURRENT | |||||
| Subordinated loans (current) | 1,002 | 340 | |||
| Unsecured subordinated loans | 83 | 83 | |||
| Development Brazilian/Dutch subsidiary | 4.95% | Fixed | 2022 | 83 | 83 |
| Secured subordinated loans | 919 | 256 | |||
| CDMO Phase 1 | 4.00% | Fixed | 2035 | 586 | 256 |
| CDMO Phase 2 | 4.00% | Fixed | 2034 | 333 | 0 |
| Other loans (current) | 10,475 | 6,186 | |||
| Straight Loans ING & CBC | Variable | 2021 | 4,000 | 5,083 | |
| Working capital funding | 5.24% | Fixed | 2023 | 108 | 71 |
| Investment loans | 2.00% | Fixed | 2023 | 77 | 107 |
| Convetible bond | 6.89% | Fixed | 2025 | 5,313 | 0 |
| Belfius | 1.89% | Fixed | 2027 | 575 | 575 |
| CBC Covid | 1.50% | Fixed | 2024 | 53 | |
| Innodem | 2.57% | Fixed | 2026 | 350 | 350 |
| Lease liabilities (current) | 7,315 | 6,746 | |||
| Leasing "Intégrale" (Immo Phase I) | 5.40% | Fixed | 2032 | 1,810 | 1,390 |
| Leasing « Intégrale » (Immo Phase II) | 5.75% | Fixed | 2034 | 535 | 412 |
| Leasing ING Lease (solar panels) | 3.00% | Fixed | 2026 | 48 | 903 |
| Leasing CBC Lease | 2.00% | Fixed | 2021 | 504 | 494 |
| Leasing ING Lease (Phase 2) | 3.00% | Fixed | 2026 | 1,054 | 1,845 |
| Leasing ING Lease (Phase I) | 3.14% | Fixed | 2026 | 1,310 | 1,402 |
| Other lease liabilities | 1.33%-1.44% | Fixed | Variable | 2,054 | 299 |
| Total current | 18,793 | 13,271 |
Straight loans are secured with pledges on receivables (EUR 7,200k); plus receivable pledge mandates (EUR 6,000k) and mortgage mandates in respect of the office building owned by the Company (EUR 1,450k) which were both given as securities for mixed credit facilities (straight loans, bank guarantees and documentary credits) under which there was EUR 4,000 straight loan drawdowns at year-end.
The 17 December 2020, Mithra issued EUR 125 million in senior unsecured convertible bonds due 17 December 2025. The Bonds will be convertible into ordinary shares of the company at an initial conversion price of EUR 25.1917, representing a 25% premium above the reference price of EUR 20.1533, being the volume weighted average price of a share on Euronext Brussels from market open to the close of trading on 10 December 2020. The Bonds were issued at 100% of their principal amount and bear a coupon of 4.250% per annum, payable semi-annualy in arrear in equal instalments on 17 December and 17 June of each year, beginning on 17 June 2021.
The convertible notes are presented in the balance sheet as follows:
Other loans (debt component of convertible bond)
| Balance at 1 January 2020 | - |
|---|---|
| Issued amount (convertible bond) | 125,000 |
| Equity component (Additional paid-in capital - Value of conversion rights on convertible bonds) |
(11,334) |
| Debt transaction costs | (2,447) |
| Interests | 92 |
| Balance at 31 December 2020 | 111,310 |
The initial fair value of the liability portion of the bond was determined using a market interest rate for an equivalent non-convertible bond at the issue date. The liability is subsequently recognised on an amortised cost basis until extinguished on conversion or maturity of the bonds. The remainder of the proceeds is allocated to the conversion option and recognised in shareholders' equity, and not subsequently remeasured.
At the date of issuance, the debt component for a total of EUR 111,310k is the present value of all cash flows (coupons and redemption) discounted at the yield of an equivalent straight bond of 6.4%. Each period the carrying amount increases by the difference between the interest expense (6.4%) and the cash coupon payment.
The equity component for EUR 11,334k is deemed to be the residual amount computed by substracting the debt component from the issue amount (recorded in additional paid-in capital). The equity component is not revalued. The effective interest rate shown in profit or loss for a simple convertible bond is equivalent to the rate that would have been paid for non-convertible debt and including transaction costs, thus here 6.89%.
The Group has also been awarded refundable advances support from the Walloon Region. Payment of awarded amounts that have not yet been received is subject to the achievement of certain milestones. Grants are subject to certain obligations. In case such obligations are not complied with, the grants could be suspended, reviewed or reclaimed. The Group has the obligation to continue the development of the project subject to the grant. In case such project is abandoned, the Group should return rights to the results and the data generated in the project to the Société Publique Wallonne (SPW), in which case the repayment obligation also lapses. The Company's ongoing grant programs are mainly refundable advances.
The refundable advances have a fixed repayment part and variable repayment scheme. The variable part is dependent on the success of the project (i.e. based on a percentage of turnover). It should be noted that, while the variable parts of these advances are only due upon commercialisation, the fixed parts are due in any event. The fixed and variable part can never exceed the double of the initial received amount. The final variable part to be repaid will depend on the performance of the product candidate.
| Year ended 31 December | |||
|---|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 | |
| Refundable government advances Estetra | 9,992 | 7,739 | |
| Other refundable government advances | 6,462 | 6,138 | |
| Total refundable government advances | 16,454 | 13,877 |
The below table gives the details of refundable governments advances granted to the group and repayments done in 2020:
| Thousands of Euro (€) | Amount of grant |
Decision year on fixed repayments part |
% of fixed repay ment part |
% applied on turnover for variable repayment part |
Maximum repayment amount |
Amount reimbursed 2020 |
|---|---|---|---|---|---|---|
| AR 7410 - Zoreline 2 | 5.265 | 01-12-2015 | 30% | 3,57% | 200% | - |
| AR 7585 - Development EVA | 1.188 | 01-11-2016 | 30% | 0,21% | 200% | 91 |
| AR 6137 – Zoreline | 1.826 | 01-12-2009 | 30% | 3,30% | 200% | 112 |
| AR 6138 - Drosperinone Novalon | 626 | 01-12-2009 | 30% | 0,50% | 200% | 27 |
| AR 7492 – Donesta | 2.898 | 01-12-2015 | 30% | 0,10% | 200% | 87 |
| AR 7551 - Bio Synthesis | 747 | 01-12-2015 | 30% | 0,26% | 200% | - |
| AR 6139 - Estelle | 2.820 | 01-12-2012 | 30% | 0,50% | 200% | - |
| AR 6926 – Estelle | 2.009 | 01-12-2012 | 30% | 0,20% | 200% | 106 |
| AR 6875 – Estelle | 5.400 | 01-12-2012 | 30% | 0,60% | 200% | 489 |
| AR 7411 - Co-extrusion CDMO | 441 | 01-12-2015 | 30% | 0,40% | 200% | 15 |
| AR 1510597 – Septime | 206 | 01-07-2016 | 30% | 0,01% | 200% | - |
| AR 1710127 Estepig | 208 | 01-12-2017 | 30% | 0,01% | 200% | - |
| AR 8792 Zoreline | 2.925 | 23-12-2019 | 30% | 1,46% | 200% | - |
| 8359 - E4 & Covid-19 | 2.105 | 30-04-2021 | 30% | 0,98% | 200% | - |
| 8433 - E4 & Covid-19 | 723 | 30-04-2021 | 30% | 0,34% | 200% | - |
| 8322 - Eco E4 | 178 | 30-09-2022 | 30% | 0,01% | 200% | - |
| Total | 29.565 | 927 |
Amortized costs adjustment of EUR 1,334k has been recorded to the amounts of refundable government advances since we updated our forecasts of sales from the related projects, the related charge has been reported in the Financial income and expenses line. The determination of the amount to be paid to the Walloon Region under the signed agreement is subject to a high degree of uncertainty as it depends on the amount of the future sales that Mithra will generate in the future.
In addition, Mithra has been granted EUR 4,8 million in non-dilutive funding from the Walloon Region end of 2020, from which EUR 2,1 million have already been received. This funding allows Mithra to advance its research program on the Covid, which is used to conduct a Phase II study program to evaluate the potential beneficial effect of Estetrol (E4) on Covid-19 infection.
| Product/projects related to the refundable advances |
Phase 2 | Phase 3 | WACC | Discount rate used for the fix part |
|---|---|---|---|---|
| Estelle® | 100% | 90% | 13.88% /11.50% |
2.27% |
| Donesta® | 100% | 38% | 13.88% | 2.27% |
| Discount rate used | ||||
| R&D | Commercial | WACC | for the fix part | |
| Zoreline® | 80% | 55% | 13.88% /13.16%/14.7% |
2.27% |
| Others | 90% | 75% | 13.88% | 2.27% |
A sensitivity analysis of the carrying amount of refundable advances has been done in case of adverse changes in assumptions, Mithra tested reasonable sensitivity to changes in the business plan and a simulated increase of up to 3 percentage point in the discount rate used would not change the findings of the Group's analysis, A sensitivity to changes in the business plan and a simulated increase of up to 10 percentage point in the probability of success of Phase III would not change the findings of the Group's analysis neither,
| Probability of success of PHASE III | |||||||
|---|---|---|---|---|---|---|---|
| Increase of BP in % | 38% | 50% | 78% | 90% | 100% | ||
| -5% | 4,534 | 5,370 | 7,322 | 8,158 | 8,855 | ||
| -3% | 4,603 | 5,462 | 7,465 | 8,323 | 9,038 | ||
| 0% | 4,673 | 5,554 | 7,608 | 8,488 | 9,222 | ||
| 3% | 4,743 | 5,645 | 7,751 | 8,653 | 9,405 | ||
| 5% | 4,813 | 5,737 | 7,894 | 8,818 | 9,589 |
Other non-current financial liabilities primarily include the fair value of the contingent consideration for Estetra (EUR 115,739k) as well as the fair value of contingent payments relating to certain contractual obligations with respect to the acquired Zoreline® and Myring® products (EUR 8,866k). The increase in the fair value of Estetra contingent consideration payable (EUR 115,739k in 2020 compared to EUR 97,392k in 2019) is the result of a payment of EUR 20,000k done to the shareholders beginning of January 2021 based on our cash position (trigerred by the convertible bonds issuance) and thus no timing effect has been discounted on that amount at 31th December 2020. For a reconciliation of the variance of the statement of income, please refer to the Note 9.17 Financial instruments.
| Total Other financial liabilities | 124,604 | 23,424 | 101,180 | 106,491 | 6,624 | 99,866 |
|---|---|---|---|---|---|---|
| Fair value Earn-out Zoreline | 5,729 | - | 5,729 | 6,115 | 352 | 5,763 |
| Fair value Earn-out Myring® | 3,137 | 507 | 2,630 | 2,983 | 271 | 2,712 |
| Fair value Earn-out Estetra | 115,739 | 22,917 | 92,821 | 97,392 | 6,000 | 91,392 |
| Total | Current | Non-Current | Total | Current | Non-Current | |
| 2020 | 2019 | |||||
| Year ended 31 December |
A sensitivity analysis has been performed on the fair value of the contingent considerations, see note 9.17 Financial instruments.
| As at 31 December | ||
|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 |
| Trade accounts payable | 23,325 | 19,449 |
| Invoices to receive | 1,927 | 5,675 |
| VAT payable | 36 | 93 |
| Salaries and social security payable | 1,309 | 857 |
| Accrued charges | 675 | 375 |
| Other debts | 0 | 665 |
| Trade payables and other current liabilities | 27,272 | 27,114 |
Trade receivables, some contract assets, some other non-current assets, trade and some other payables, refundable government advances, borrowings and lease liabilities are financial assets or liabilities carried at amortized cost. The other financial instruments are carried at fair value.
Fair values are measured according to the following hierarchies:
| Balance at 31 December |
Recognised fair value |
Fair value measurement |
Unrecognised fair value |
|
|---|---|---|---|---|
| Thousands of Euro (€) | 2020 | measurements | hierarchy | measurements |
| Financial assets | ||||
| Financial assets at fair value through profit and loss | ||||
| Other non-current assets – contingent consideration receivable |
7,999 | 7,999 | Level 3 | - |
| Contract assets – Mayne shares receivable | 18,670 | 18,670 | Level 1 | - |
| Current derivative hedges | 14 | 14 | Level 2 | - |
| Financial assets at fair value through other comprehensive income |
||||
| Investments in equity securities | 18,088 | 18,088 | Level 1 | - |
| Current hedge derivatives | 2,867 | 2,867 | Level 2 | - |
| Non-current hedge derivatives | 6,184 | 6,184 | Level2 | - |
| Financial assets at amortised cost | ||||
| Other non-current assets - other than above | 6,402 | - | - | 6,402 |
| Contract assets - other than above | 33,002 | - | - | 33,002 |
| Trade and other receivables | 10,052 | - | - | 10,052 |
| Other short term deposits | 14 | - | - | 14 |
| Cash and cash equivalents | 138,675 | - | - | 138,675 |
| Financial liabilities | ||||
| Liabilities at amortised cost | ||||
| Subordinated loans | 13,467 | - | - | 13,467 |
| Others loans | 11,156 | - | - | 11,156 |
| Refundable government advances | 16,454 | - | - | 16,454 |
| Trade payables, Accrued charges & other financial liabilities |
27,272 | - | - | 27,272 |
| Lease liabilities | 51,650 | - | - | 51,650 |
| Other loans (Debt component of convertible bond) | 111,310 | 111,310 | Level 2 | - |
| Financial liabilities at fair value through profit or loss | ||||
| Other financial liabilities | 124,604 | 124,604 | Level 3 | - |
| Balance at 31 December |
Recognised fair value |
Fair value measurement |
Unrecognised fair value |
|
|---|---|---|---|---|
| Thousands of Euro (€) | 2019 | measurements | hierarchy | measurements |
| Financial assets | ||||
| Financial assets at fair value through profit and loss | ||||
| Other non-current assets – contingent consideration receivable |
7,999 | 7,999 | Level 3 | - |
| Contract assets – Mayne shares receivable | 23,595 | 23,595 | Level 1 | - |
| Financial assets at fair value through other comprehensive income |
||||
| Investments in equity securities | 22,860 | 22,860 | Level 1 | - |
| Financial assets at amortised cost | ||||
| Other non-current assets - other than above | 5,097 | - | - | 5,097 |
| Contract assets - other than above | 38,622 | - | - | 38,622 |
| Trade and other receivables | 12,238 | - | - | 12,238 |
| Other short term deposits | 46 | - | - | 46 |
| Cash and cash equivalents | 49,720 | - | - | 49,720 |
| Financial liabilities | ||||
| Liabilities at amortised cost | ||||
| Subordinated loans | 12,770 | - | - | 12,770 |
| Others loans | 12,812 | - | - | 12,812 |
| Refundable government advances | 13,877 | - | - | 13,877 |
| Trade payables | 27,114 | - | - | 27,114 |
| Lease liabilities | 52,474 | - | - | 52,474 |
| Financial liabilities at fair value through profit or loss | ||||
| Other financial liabilities | 106,490 | 106,490 | Level 3 | - |
The fair value of trade and other receivables, other short-term deposits and cash and cash equivalents does not materially differ from their carrying amounts. Fair value would typically be measured as Level 2. The fact that their carrying value approximates their fair value is due to the short maturity of these assets.
For a significant part of the loans, the fair values are not materially different to their carrying amounts, since the interest payable on those loans is close to current market rates because they are recent, or the loans have short maturities. For Lease liabilities the incremental borrowing rate has been determined at transition to IFRS 16 on 1 January 2019.
There are four categories of financial assets: Contingent Consideration, Contract Assets, Investments in Equity Securities and hedge derivative instruments.
| Assets reported at fair value | Fair value measurement hierarchy |
Balance at 31 December 2020 |
|---|---|---|
| Other non-current assets – contingent consideration | Level 3 | 7,999 |
| Contract assets – Mayne shares receivable | Level 1 | 18,670 |
| Investments in equity securities | Level 1 | 18,088 |
| Hedge derivatives | Level 2 | 9,065 |
| Balance at 31 December 2020 | 53,822 |
Knowing that several earn out payments will be due to Mithra depending on the financial performance of the assets sold, the fair value of the contingent consideration receivable related to Ceres has been estimated based on a most likely amount where the Group expects to receive two milestones for a total of EUR 10 million by 2023. A discount rate is finally applied to the expected cash flows. The discount rate used was 11,9% and remain unchanged since 31 December 2019.
Regarding the contract assets, the variability associated with the Mayne share price gives rise to an embedded derivative so that in accordance with IFRS 9, the receivable is reported at fair value through profit or loss.
Roll forward of contract assets related to Mayne shares at fair value through income statement after shares reevaluation at 31 December 2020:
| Thousands of Euro (€) | Contract assets |
|---|---|
| Balance at 1 January 2020 | 23,595 |
| Additions | - |
| Fair value change through income statement | (4,925) |
| Balance at 31 December 2020 | 18,670 |
Financial assets at fair value through other comprehensive income (FVOCI) comprise equity securities which are not held for trading, and which the group has irrevocably elected at initial recognition to recognise in this category. These are strategic investments and the group considers this classification to be more relevant.
Roll-forward of equity investments at fair value through other comprehensive income after equity securities reevaluation at 31 December 2020:
| Thousands of Euro (€) | Equity securities |
|---|---|
| Balance at 1 January 2020 | 22,860 |
| Fair value through OCI | (4,772) |
| Balance at 31 December 2020 | 18,088 |
On disposal of these equity investments, any related balance within the FVOCI reserve is reclassified to retained earnings. Please refer to 9.14 Share Capital for more details.
Changes in Contract Assets and Equity Investments relating to Mayne shares are explained by decreases in Mayne's share price as well as the AUD / EUR conversion rate as of December 31, 2020.
The Group entered into derivative financial instruments to manage its exposure to foreign exchange rate risk arising from operational activities (cash flow hedges). The effective portion of changes in the fair value of derivative financial instruments qualifying as cash flow hedges is deferred to equity. Amounts deferred in equity are subsequently released to the income statement in the periods in which the hedged transaction impacts the income statement.
| Thousands of Euro (€) | Equity securities |
|---|---|
| Balance at 1 January 2020 | - |
| Fair value through OCI | 9,065 |
| Balance at 31 December 2020 | 9,065 |
For the measurement of the fair value under IFRS and the roll forward of financial liabilities, please refer to the table below, We considered a level 3 under the fair value measurement hierarchy:
| Thousands of Euro (€) | |||
|---|---|---|---|
| Assets recognized or disclosed at fair value | Fair value measurement hierarchy |
31 December 2020 | 31 December 2019 |
| Non-Current Other financial liabilities | Level 3 | 101,18 | 99,866 |
| Current Other financial liabilities | Level 3 | 23,424 | 6,624 |
| Balance at 31 December 2020 | 124,604 | 106,49 |
For the roll forward of financial liabilities, please refer to the table below.
| Thousands of Euro (€) | Financial liabilities |
|---|---|
| Balance at 1 January 2020 | 106,490 |
| Fair value change through profit or loss of other financial liabilities | 18,114 |
| Balance at 31 December 2020 | 124,604 |
The following table shows the disaggregation of the Level 3 financial liability instruments:
| Other financial liabilities | |
|---|---|
| Estelle® | 115,739 |
| Zoreline® | 5,729 |
| Myring® | 3,137 |
| Balance at 31 December 2020 | 124,604 |
The fair value of the contingent payments has been determined using a probability weighting approach applied to discounted cash flows, When relevant, a risk-adjusted discounted cash flow model was used where all future cash flows are probabilized and then discounted using a specific updated WACC applicable to each product concerned.
| Contingent considerations relating to Estelle® |
Total cash-out until 2028 |
Partial cash-out until 2028 |
Net Present Value |
|---|---|---|---|
| Alternative 1 | 50% | 50% | 107,921 |
| Alternative 2 | 60% | 40% | 115,739 |
| Alternative 3 | 70% | 30% | 125,087 |
Alternative 1 and Alternative 3 are not used for the measurement of the liability but are to be used for disclosing sensitivity of the value to the probability factors used (a level 3 input).
The increase of fair value for the contingent consideration for Estelle® (EUR 115,739k in December 2020 compared to 97,392k in 2019) is mainly due to timing effect, The WACC used in 2020 is 11.87% and was not changed since 31th December 2019.
| Contingent considerations relating to Estelle® |
Total cash-out until 2028 |
Partial cash-out until 2028 |
Net Present Value |
|---|---|---|---|
| Alternative 1 | 50% | 50% | 88,541 |
| Alternative 2 | 60% | 40% | 97,392 |
| Alternative 3 | 70% | 30% | 106,240 |
| Amount fair valued |
R&D | Commercial | WACC | |
|---|---|---|---|---|
| Zoreline® | 5,729 | 80% | 55% | 14.70% |
| Myring® | 3,137 | 90% | 75% | 12.80% |
| Total contigent considerations for others | 8,866 |
The decrease in fair value for the contingent consideration for the other earn outs (EUR 8,866k in 2020 compared to EUR 9,098k in 2019) is the result of a change of the timing effect.
| Total contigent considerations for others | 9,098 | |||
|---|---|---|---|---|
| Myring® | 2,983 | 90% | 75% | 12.80% |
| Zoreline® | 6,115 | 80% | 55% | 14.70% |
| Amount fair valued |
R&D | Commercial | WACC |
The Group's revenue consists of product sales and license revenues as follows:
| Year ended 31 December | ||
|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 |
| Product Sales | 3,576 | 3,607 |
| Out-licensing | 5,446 | 91,645 |
| Other | 0 | 1,268 |
| Total Revenues | 9,030 | 96,520 |
Group revenues decreased to EUR 9,030k in 2020 (EUR 96,520k in 2019) and are mainly driven by product sales, including the first sales of Myring® in Europe, and by Estelle® out-licensing fees in Latin America. The reasons for the decrease are twofold. On the one hand, no significant additional performance obligations were considered as highly probable by Mithra, meaning that no revenue on backlog of signed contracts was recognised. On the other hand, no significant partnership was signed during 2020. This reflects the business development strategy for Donesta®, which is progressing well, targeting major global partners. At the same time, we are generating more data in the Phase III trial to be able to conclude a higher deal value.
The Group has disaggregated revenue into various categories in the following table which is intended to:
| Year ended 31 December 2020 | |||
|---|---|---|---|
| Thousands of Euro (€) | Product sales | Out-licensing | Others |
| Primary Geographic Markets | |||
| Europe | 2,582 | 924 | - |
| Outside Europe | 994 | 4,522 | - |
| Total | 3,576 | 5,446 | - |
| Product type | |||
| Generics | 3,576 | (43) | - |
| E4 contraception | - | 4,967 | - |
| E4 Menopause | - | - | - |
| Others | - | 522 | - |
| Total | 3,576 | 5,446 | - |
| Timing of transfer of goods and services | |||
| At a point in time | 3,576 | 5,446 | |
| Over time | - | - | - |
| Total | 3,576 | 5,446 | - |
| Year ended 31 December 2019 | |||
|---|---|---|---|
| Thousands of Euro (€) | Product sales | Out-licensing | Others |
| Primary Geographic Markets | |||
| Europe | 2,678 | 15,701 | 1,268 |
| Outside Europe | 929 | 75,944 | - |
| Total | 3,607 | 91,645 | 1,268 |
| Product type | |||
| Generics | 3,607 | 1,001 | - |
| E4 contraception | - | 90,644 | - |
| E4 Menopause | - | - | - |
| Others | - | - | 1,268 |
| Total | 3,607 | 91,645 | 1,268 |
| Timing of transfer of goods and services | |||
| At a point in time | 3,607 | 91,645 | 114 |
| Over time | - | - | 1,154 |
| Total | 3,607 | 91,645 | 1,268 |
Amounts received or milestones to be received in the near future have been recognized as revenue to the extent that it is highly probable that no reversal will be done in the future.
Most of the out-licensing contracts have a single performance obligation which is the grant of the license. Some contracts also contain other performances such as manufacture and supply obligations, which are distinct from the license grant.
An analysis has been conducted in order to determine whether the single performance obligation was satisfied as at 31 December 2020.
The tables below present the roll forward of the related contract assets:
| Balance at 31 December 2020 | 51,672 |
|---|---|
| Other | (143) |
| Revenue billed in 2020 already recognized in previous years | (5,500) |
| Unrealized exchange loss | (827) |
| Fair value loss through income statement | (4,925) |
| Contracts agreed during the period 2020 | 1,350 |
| Change in an estimate of the transaction price | (500) |
| Balance at 1 January 2020 | 62,217 |
| Thousands of Euro (€) |
As at 31 December 2020, the balance takes into account unbilled revenue for EUR 51,7 million (EUR 62,2 million end of 2019), among which EUR 15 million related to Gedeon Richter for Estelle® (decrease of EUR 5 million invoiced compared to 2019), EUR 7,6 million related to Mayne Pharma for Myring® and EUR 28,8 million related to Mayne for Estelle.
The contract liabilities are the result of some amounts already invoiced to customers but not recognized in revenue as the related performance obligations were not yet satisfied as at 31 December 2020. Contract liabilities consists in milestones received in the context of the Zoreline license agreement (EUR 3,6 million), whose recognition is contingent upon obtaining regulatory approval in the different countries of the partner territory.
As at 31 December 2020, down-payments received prior to 31 December 2019 for R&D services for EUR 350k have been recognized as revenue.
| Contract liabilities | Thousands of Euro (€) |
|---|---|
| Balance at 1 January 2019 | 4,017 |
| Change in an estimate of the transaction price | - |
| Recognition as revenue | 350 |
| Balance at 31 December 2020 | 3,667 |
| Year ended 31 December | ||
|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 |
| R&D Tax credit | 1,864 | 1.360 |
| Grant income | 2,833 | 2.555 |
| Other revenues | 1,877 | 1.486 |
| Other operating income | 6,574 | 5,401 |
Other operating income is rather stable and mainly composed of R&D tax credit and grant income. In 2020, the Group applied for EUR 1,864k additional R&D tax credit (please refer to the note 9.2.25 R&D tax credit). Additional grant income has been recognized in 2020 on grants in the form of recoverable cash advances (EUR 581k, please refer to the note 9.15.2) and on grants from the Walloon Region (EUR 2,252k, not referring to recoverable cash advances and not subject to reimbursement).
A breakdown of the expenses by nature of the costs of goods sold, research and development costs, general and administrative and selling costs is summarized below. A breakdown of the employee benefit expenses is given in note 9.21.
| Year ended 31 December | |||
|---|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 | |
| Costs by nature | |||
| Trade goods, raw materials and consumables | 5,836 | 4,426 | |
| Employee benefit expenses | 17,372 | 15,987 | |
| External service providers | 58,368 | 40,229 | |
| Corporate branding expenses | 695 | 1,923 | |
| Depreciation, amortization and impairment charges | 9,873 | 5,777 | |
| Commissions | 70 | 666 | |
| Operating lease payments | 83 | (86) | |
| Other expenses | 6,985 | 6,951 | |
| Total costs by nature | 99,282 | 75,873 |
| Costs by type | ||
|---|---|---|
| Cost of sales | 3,457 | 2,487 |
| Research and development expenses | 78,458 | 57,073 |
| General and administrative expenses | 15,933 | 14,774 |
| Selling expenses | 1,434 | 1,539 |
| Total costs by type | 99,282 | 75,873 |
R&D expenses increased by 37% in 2020 to EUR 78,458k (2019: EUR 57,073k) due to the ramp up of the Donesta® Phase III "E4 Comfort" clinical program and the Covid study, launched in the second semester 2020.
Increase in G&A expenses is essentially due to non-cash accounting entries related to share-based payments expense (EUR 7,267k compared to EUR 4,898k in 2019). Without these non-cash elements, G&A would have decreased by EUR 1,210k compared to last year, even if the build up of our activities was significant over the period.
The costs related to personnel and mandated contractors can be summarised as follows:
| Year ended 31 December | ||
|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 |
| Wages, salaries, fees & bonuses | 13,648 | 10,840 |
| Pension costs: defined contribution plan | 342 | 249 |
| Share-based payments | 7,267 | 4,898 |
| Total | 21,257 | 15,987 |
In 2020, the Group employed 229 full time employee's at year-end (172 full time employee's in 2019) which can be allocatedtothe followingdepartments:
| As at 31 December | ||
|---|---|---|
| Number of employees | 2020 | 2019 |
| Research and development staff | 51 | 50 |
| General and administrative staff | 178 | 122 |
| Total | 229 | 172 |
The Group offers several post-employment, death, disability and healthcare benefit schemes. All employees have access to these schemes. The death, disability and healthcare benefits granted to employees of the Group are covered by external insurance companies, where premiums are paid annually and charged to the income statement as they become payable.
The post-employment pension plans granted to employees of the Group are defined contribution plans. A defined contribution plan is a pension plan under which the Group pays a fixed contribution into a separate entity. The contribution obligations to the defined contribution plans are expensed by the Group in the income statement as they were incurred. Although defined contribution plans in Belgium are legally subject to a minimum guaranteed return of 1,75% on employer contributions and employee contributions, the post employment pension plans are accounted for as defined contribution plans, since the legally required return is guaranteed by the external insurance company. Any liability that may currently result isimmaterial.
| Thousands of Euro (€) | Year ended 31 December | ||
|---|---|---|---|
| 2020 | 2019 | ||
| Interest income | - | - | |
| Realized foreign exchange gains | 1,612 | 115 | |
| Other financial income | 171 | 156 | |
| Total financial income | 1,783 | 271 |
Financial income increased by EUR 1,512k and is mainly explained by the realized exchange gain on foreign USD hedging contract (EUR 862k recorded in profit or loss accounts) and other realized exchange gains.
| Thousands of Euro (€) | Year ended 31 December | ||
|---|---|---|---|
| 2020 | 2019 | ||
| Interest payments | (3,503) | (3,321) | |
| Remeasurement of refundable government advances | (1,355) | (3,218) | |
| Unrealized foreign exchange losses | (828) | (121) | |
| Realized foreign exhange losses | (242) | - | |
| Other financial expenses | (59) | (45) | |
| Total financial expense | (5,987) | (6,705) |
Financial expenses primarily include interest accruing on the bank borrowings (see note 9.15) for the CDMO plateform and the remeasurment of refundable government advances.
The tax expenses consist of:
| Year ended 31 December | ||
|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 |
| Current tax income / (expense) | (35) | (351) |
| Deferred tax income/(expense) related to temporary differences and tax losses |
18,871 | 5,440 |
| Withholding tax income / (expense) | (1) | (230) |
| Total | 18,835 | 4,859 |
The income taxes in 2019 and 2020 are still the result of temporary differences and tax losses carried forward, and is thus a non-cash item.
The Group reported a total deferred tax asset of EUR 18,871k as at 31 December 2020, This deferred tax is to be set off against future taxable income.
The consolidated unused tax losses carried forward at 31 December 2020 amounted to 112 million euros, with expiry dates between 2025 and 2027.
The tax result for the year can be reconciled as follows:
| Year ended 31 December | ||
|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 |
| Income / Loss (-) before tax | (110,922) | (31,424) |
| Country's statutory tax rate | 25% | 29,58% |
| Tax expenses / income (-) (theoretical) | (27,730) | (9,295) |
| Tax expenses / income (-) in income statement (effective) | (18,835) | (4,859) |
| Difference in tax expenses / income (-) to explain | 8,896 | 4,436 |
| - Tax credit for R&D investments | (466) | (414) |
| - Non-taxable revenues | (2,179) | (10,141) |
| - Temporary differences with different tax rates | - | (2,560) |
| - Tax losses for which no deferred tax income was recognised | 10,154 | 14,652 |
| - Share-based payment expenses | 1,817 | 1,449 |
| - Withholding taxes | 1 | 230 |
| - Tax losses recognized with different tax rates | - | 776 |
| - Other | (431) | 444 |
| Total | 8,896 | 4,436 |
A detailed overview of the deferred tax asset is shown below:
| after more than 12 months Deferred tax assets |
50,905 | 34,431 | |
|---|---|---|---|
| Deferred tax asset to be recovered | 50,905 | 34,431 | |
| Thousands of Euro (€) | 2020 | 2019 | |
| As at 31 December |
The increase of EUR 16,474 k is mainly explained by the increase of tax losses in 2020 in the subsidiaries of the Group and by the temporary difference arising from the increase of the fair value of the Estetra earn out in 2020 on which deferred tax asset is computed
Management is convinced that such companies will generate sufficient profits in the future in order to be able to recover the fiscal losses carried forward and justify the recognition of the deferred tax asset particularily for Estetra thanks to ongoing contract negotiations related to Estelle® that will generate much profits in the coming years.
In February 2020, the Company announced that it had received a positive ruling from the Belgian tax authorities enabling it to benefit from the Belgian Patent Income Deduction (PID) on patent related income arising from Estetrol (E4) based products, namely Estelle® and Donesta®. Through the utilization of the tax losses carried forward and these PID/IID deductions. Mithra expects to significantly reduce its effective tax rate to less than 5% for its E4 product pipeline, compared to 25% for the standard Belgian commercial tax rate. This low rate is expected to apply to the majority of future income related to E4-based products, including PeriNesta®.
The movement in the deferred tax asset is as follows:
| Temporary Differences | |||
|---|---|---|---|
| Contingent consideration |
Other | Tax Losses |
Total |
| 16,906 | (3,898) | 14,038 | 27,045 |
| 1,007 | 2,144 | 4,234 | 7,385 |
| 17,913 | (1,754) | 18,272 | 34,431 |
| 3,356 | 896 | 12,222 | 16,474 |
| 21,269 | (858) | 30,494 | 50,905 |
The deferred tax liabilities (EUR 4,363k in 2020 and EUR 4,148k in 2019) result from temporary differences arising fromthe difference between the fair values of assets acquired atthe acquisition date and their tax bases, DTA and DTL are offset by legal entity,
Basiclossper shareiscalculated bydividingthenetresult attributable toshareholdersby theweightedaverage number of shares.
The basic and diluted earnings per share are identical due to inclusion of potential ordinary share will result in an antidilutive effect:
| Year ended 31 December | ||
|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 |
| Result for the purpose of basic loss per share | (92,086) | (26,594) |
| Weighted average number of shares for the purpose of basic loss per share |
40,988,235 | 37,751,788 |
| Basic loss per share (in Euro) | (2.25) | (0.70) |
| Diluted loss per share (in Euro) | (2.25) | (0.70) |
By a decision ofthe extraordinary shareholders' meeting of 2 March 2015 the Company issued 1089 warrants primarily to key management with an exercise price of EUR 5,646 per warrant. Warrants are conditional on the person completing 4 years of service (vesting period). These warrants are exercisable as of 2019. The fair value of the 1.089 warrants at grant date is estimated at EUR 2,789k.
During the reporting year 2019 two capital increases have taken place due to the exercise of warrants (15 warrants on January 30, 2019 and 15 warrants on April 24, 2019).
On January 30, 2019, a capital increase took place following the exercise of 15 warrants within the 2015 Warrant Plan ("2015 Warrant Plan") corresponding to a contribution of EUR 84,690. In accordance with the 2015 Warrant Plan, the exercise period started on January 1, 2019. An amount of EUR 18,119.48 was therefore contributed in cash to the share capital of Mithra and the balance of EUR 66,570.52 was allocated to the Company's "share premium" account. This exercise of 15 warrants resulted in the issue of 24,750 shares (1 warrant being equivalent to 1,650 shares) which on February 13, 2019 were admitted to listing on the regulated market. As a result, Mithra's share capital on January 30, 2019 amounted to EUR 27,573,880.18 corresponding to 37,664,245 ordinary shares.
A second capital increase took place on April 24, 2019, following the exercise of 15 warrants from the 2015 Warrant Plan ("2015 Warrant Plan") corresponding to a contribution of EUR 84,690. An amount of EUR 18,119.40 was therefore contributed in cash to the share capital of Mithra and the balance of EUR 66,570.52 was allocated to the Company's "share premium" account. This exercise of 15 warrants resulted in the issue of 24,750 shares (1 warrant being equivalent to 1,650 shares) which, on May 9, 2019, were admitted to listing on the regulated market. As a result, Mithra's share capital at April 24, 2019 amounted to EUR 27,591,999.58 corresponding to 37,688,995 fully paid-up ordinary shares. The shares have no par value, but represent the same fraction of the Company's share capital, which is denominated in euros. Each share entitles its holder to one voting right.
On 5 November 2018, Mithra's extraordinary general meeting approved the issuance of a maximum of 1,881,974 warrants under the "Warrant Plan 2018", for the benefit of key employees, members of the management team and certain directors with an exercise price of EUR 24.05 or EUR 24.09 depending on the status (employee or not) of the beneficiary. The warrants have a term of five years as from the date of issuance. They are generally not transferable and, in principle, cannot be exercised prior to the date of the grant's second anniversary (i.e. at the earliest 6 November 2020 subject to exercise conditions). All of the offered warrants are subject to a service condition of two years. Furthermore, a portion of 30% of these offered warrants were subject to additional market and non-market vesting conditions. The market condition, upon which the vesting is dependent from the share market price, was included in the grant date fair value calculation (see the discount applied in the table below). This condition was met during financial year 2019. Out of the maximum of 1,881,974 warrants which have been issued, a number of 1,394,900 warrants (corresponding to 1,394,900 new shares) were offered and accepted by the beneficiaries. The remaining warrants are unused as the Board of Directors undertook not to offer them by issuing the Warrant Plan 2020 pursuant to the CCA.
Roll forward of the number of warrants :
| As of 31 December | 18.77 | 2,701,520 | 1,307,825 |
|---|---|---|---|
| Expired | - | - | |
| Exercised | - | (30) | |
| Forfeited | - | (96,357) | |
| Granted | 24.80 | 1,393,695 | 165,223 |
| Outstanding and granted as of 1st January |
15.68 | 1,307,825 | 1,238,989 |
| Number of warrants | Weighted average exercise price (in Euro) |
2020 Number of warrants |
2019 Number of warrants |
| Year ended 31 December |
Regarding warrant Plan 2018, out of the maximum of 1,881,974 warants, a total of 1,394,900 warrants have been offered and accepted, As the exercise price is different for management companies and for employees, we've determined two different fair value amounts. The fair value of the warrants at grant date is estimated at EUR 13,994k. The fair value of each option is estimated using the Black & Scholes model based on the following assumptions: (i) first we valued separately the warrants granted to the management co's and those granted to the employees, (ii) secondly, we also valued separately the warrants that are subject to vesting conditions from those who were already definitely acquired by the beneficiaries upon grant,
The fair value of the warrants at grant date was estimated at EUR 6,705k for the warrants definitely acquired and EUR 2,918k for the remaining 30% subject to vesting conditions, at EUR 4,370k for warrants acquired at 100% and at EUR 2,189k for warrants granted to LDA lenders and LDA.
In July and September 2020, the Company summoned two Extraordinary General Meetings during which the issuance of two warrant plans were approved: (i) a warrant plan for the benefit of LDA Capital Ltd, under which a maximum of 690,000 warrants were to be issued pursuant to the transaction announced by the Company on April 23, 2020 and (ii) another warrants plan for the benefit of reference shareholders ("Share Lending Warrants") for a maximum of 300,000 warrants.
The first plan is accounted for using IFRS 2 because 690,000 warrants exercisable at EUR 27 with an expiry date of 23 April 2023, were issued to LDA Capital as part of the EUR 50 million standby equity funding facility costs. Upon signing the Put Option Agreement on 23 April 2020, it provided Mithra the flexibility to draw down capital as required at their election and accordingly, a vesting period of 3 years was considered due to the capital commitment made for this period, at the end of which the full warrants will become exercisable (knowing that the warrants become exercisable within this period in proportion of the funding ratio). As such, EUR 220k from the total fair value (EUR 1,581k) of the options granted at that date was expensed in the profit and loss statement for the year ended 31 December 2020, the remaining part will be taken into expenses until the end of the 3 years of vesting period.
Same treatment has been applied on the second plan ("Share Lending Warrants") in compensation for their service of supporting the construction of this financing deal by lending their shares for each of the future equity transactions to be executed. As such, EUR 68k from the total fair value (EUR 608k) of the options granted at that date was expensed in the profit and loss statement for the year ended 31 December 2020, the remaining part will be taken into expenses until the end of the 3 years of vesting period.
The fair value of each option is estimated using the Black & Scholes model based on the following assumptions:
| Plan 2015 | Plan 2018 (Grant 1 - 70%) |
Plan 2018 (Grant 1 - 30%) |
Plan 2018 (Grant 2 - 100%) |
Plan 2018 (Grant 3 - 100%) |
|
|---|---|---|---|---|---|
| Number of warrants granted |
1,089 * (1,650 shares) |
866,837 | 371,502 | 97,695 | 67,528 |
| Exercise price per warrant | EUR 5,646 | EUR 24.05- 24.09 |
EUR 24.05-24.09 | EUR 24.09-25.72 | EUR 25.5-27.5 |
| Expected dividend yield | - | - | - | - | - |
| Expected stock price volatility |
45.30% | 37.50% | 37.50% | 37.50% | 37.50% |
| Risk-free interest rate | 0.53% | 0.36% | 0.36% | 0.36% | 0.36% |
| Expected duration | 8 years | 5 years | 5 years | 5 years | 5 years |
| Fair value at grant date | EUR 2,789k | EUR 6,705k | EUR 2,918k | EUR 753k | EUR 586k |
| Discount related to market condition |
- | - | 14.37% | - | |
| Plan 2018 (Grant 4 - 100%) |
Plan 2020 (LDA) |
Plan 2020 (LDA) |
Plan 2020 (Mgmt) |
||
| Number of warrants granted |
87,695 | 690,000 | 300,000 | 316,000 | |
| Exercise price per warrant | EUR 16,54 | EUR 27 | EUR 27 | EUR 17,87 | |
| Expected dividend yield | - | - | - | - | |
| Expected stock price volatility |
37,50% | 37,50% | 37,50% | 37,50% | |
| Risk-free interest rate | 0,36% | 0,36% | 0,36% | 0,36% | |
| Expected duration | 5 years | 3 years | 3 years | 10 years | |
| Fair value at grant date | EUR 479k | EUR 1,581k | EUR 608k | EUR 2,552k |
The annualized standard deviation in the stock price has been determined based on historical estimate while the risk-free interest rate has been determined based on a government bond with maturity closest to option expiration.
During the period 2020, a charge of EUR 7,267k has been recognized at the consolidated statement of income.
| Thousands of Euro (€) | ||||
|---|---|---|---|---|
| Assets | Land and Buildings |
Fixtures and equipment |
Vehicles | TOTAL |
| Balance at 31 December 2019 | 42,551 | 27,478 | 506 | 70,535 |
| Additions | 379 | 3,416 | 469 | 4,264 |
| Grants related to assets | - | (1,724) | - | (1,724) |
| Depreciation right-of-use assets | (2,487) | (510) | (504) | (3,501) |
| Net carrying amount of right-of-uses assets at 31 December 2020 |
40,443 | 28,660 | 471 | 69,574 |
| Thousands of Euro (€) | |
|---|---|
| Liabilities | |
| Balance at 31 December 2019 | (52,474) |
| Additions | (2,651) |
| Capital payments | 3,475 |
| Total of lease Liabilities at 31 December 2020 | (51,650) |
| Current Lease liabilities | (7,368) |
| Non-current Lease liabilities | (44,282) |
The statement of profit or loss shows the following amounts relating to leases:
| As at 31 December | |||
|---|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 | |
| Depreciation charge of right-of-use assets | |||
| Land and Buildings | (2,487) | (2,217) | |
| Fixture and Equipment | (510) | (379) | |
| Vehicles | (504) | (413) | |
| Others | - | - | |
| Total | (3,501) | (3,009) | |
| Interest expense (included in finance cost) | (2,241) | (3,060) | |
| Expense relating to short-term leases | (83) | (49) | |
| Expense relating to leases of low-value assets that are not shown above as short-term leases Expense relating to variable lease payments not included in lease liabilities |
- - |
- - |
Since 2008, Mithra is involved in a legal proceeding against Organon NV (now Merck Sharp and Dohme BV). The proceeding concerns the alleged patent infringement caused by the commercialisation by Mithra and its partner DocPharma BVBA (now Mylan) of a generic drug named Heria. Currently, Organon is claiming for provisional damages of EUR 2,770k including actual loss of profit as well as the reimbursement of cost for establishing the infringement attorney's fees and expert's expenses. A first instance judgement, was rendered on 11 December 2015 that concluded in a partial infringement of Organon's patent. An expert was appointed by Commercial Court to advise on the damages suffered by Organon and Merck because of the partial infringement. A final report of the judicial expert dated November 22, 2019 assessed that damage at EUR 551k. That amount is, however, questionable in the light of several objective factors. The case is pending at the appeal level and the hearing has not yet been fixed.
A provision of EUR 341k has been recorded in the accounts in accordance with management's assessment of the liability that can result.
For more details on contingent consideration payments, reference is made to section 9.17.4.
The contingent considerations relating to the asset deal Donesta® are not accounted for based on accounting policy 9.2.6.
As the acquisition of Donesta® qualified as an asset deal – because the definition of a business as defined in IFRS 3 was not met – the transaction was measured initially at cost. Subsequently the intangible assets will be measured at their cost less any accumulated amortisation and any accumulated impairment losses. The transaction price further contains several instalments which, since the date of acquisition, are considered as a contingent price based on future performance, hence this measurement is more an attribute of fair value measurement throughout the life of the asset than being representative of the cost model upon initial recognition of the asset. Hence, the contingent payments are disclosed as a contingent liability for an amount of EUR 12,000k, with any liability being re-measured at the end of each reporting period as an adjustment to the cost of intangible assets to the extent that it relates to future reportingperiods.
In September 2019, Mithra contracted with ICON Plc to manage the pivotal Phase III trial of Donesta® to demonstrate the long-term efficacy and safety of Estetrol in the relief of vasomotor symptoms in postmenopausal and hysterectomized women in the US. The total study budget was on 31st December 2020 of approximately USD 48,4 million.
On November 6, 2019, the Company also entered into a contract with ICON Plc for a similar study in Europe and the rest of the world. The total budget for the study was on 31st December 2020 of approximately EUR 35 million.
In July 2020, the Company selected KCR S.A. (Polish joint-stock company) with its registered office in Warsaw at 6 Postępu Str., 02-676 Warsaw as CRO to manage the Coronesta study (i.e. the impact of E4 in the treatment of Covid 19) for an approximated budget of EUR 5,6 million.
The Company has implemented processes to enable its compliance with provision 7:97 CCA. During this fiscal year 2020, no related party transactions within the meaning of the IAS 24 which satisfied the requirements of provision 7:97 CCA have been reported (article 7:97§4 CCA). As provided in section 1.10 Conflicitng Interests, members of the Board have requested the advice of independent directors as far as necessary and applicable for two operations ( Board decision of 22 May 2020 and Board of 18th June 2020- please refer to section 1.10). However, theses transactions did not fit the requierements of provision 7.97 CCA.
Additionally, the Company has no reporting event linked to the application of article 7:97 §6 CCA.
For fiscal year 2020, the related parties with which other transactions have occurred, but who are below the materiality threshold as foreseen by provision 7:97 CCA are as follows:
• Protection Unit SA an entity in which Mr François Fornieri (managing director of the Company) is shareholder and where NOSHAQ Partners SCRl (director of the Company) is director.
Transactions between the Company and its subsidiaries, which are related parties, are eliminated in the consolidated accounts and no further information is provided here in this Section. However, the associate Targetome has been included as a related party.
In 2020, Mithra did not acquire assets from related parties.
Refer to the table below for the compensations paid to key management:
| Thousands of Euro (€) | Total | Of which CEO |
|---|---|---|
| Basic Remuneration | 2,532 | 919 |
| Variable Remuneration (*) | - | 0 |
| Group Insurance (pension, invalidity, life) | 2 | 0 |
| Other insurance (car, cell phone, hospitalization) | 5 | 0 |
| Total | 2,538 | 919 |
| Thousands of Euro | Type of services | 2020 | 2019 |
|---|---|---|---|
| Total services rendered to entities controlled by or with significant influence from key management / directors |
3 | 607 | |
| Ceres | Reinvoicing diverse expense | 3 | 607 |
| Total services purchased from entities controlled by or with significant influence from key management / directors |
543 | 449 | |
| YIMA SRL | Rental services builiding Foulons | 168 | 157 |
| YIMA SRL | Share lending facility | 17 | - |
| Bocholtz | Membership | 4 | 6 |
| Alychlo NV | Share lending facility | 17 | - |
| Noshaq SA | Share lending facility | 34 | - |
| Protection Unit | Guarding | 302 | 285 |
As per IAS 24 definition of "related parties transaction", the Company purchased services in the form of share lending facility from the below reference shareholders. In exchange for their services, the Company has granted warrants to those shareholders in proportion to their sharelending.
| Thousands of Euro (€) | 2020 | 2019 |
|---|---|---|
| Receivables from entities controlled by or with significant influence from key management / directors |
39 | 784 |
| Payables to entities controlled by or with significant influence from key management / directors |
160 | 283 |
| Payables to other related parties | 0 | 0 |
| Thousands of Euro (€) | 2020 | 2019 |
|---|---|---|
| Loan from / to entities controlled by key management / directors | 0 | 0 |
The total amount of the remunerations and the benefits paid in 2020to the non-executive Directors (in such capacity) was EUR 258,107(gross, excluding VAT), split as follows:
| Name | Nature | Remunerations | As member of a committee |
As chairman of the board |
|---|---|---|---|---|
| CG Cube SA | Non-exec | 18,044 | ||
| NOSHAQ SA | Non-exec | 20,000 | 10,000 | |
| Alychlo NV | Non-exec - Chair | 16,667 | 16,667 | |
| P. Suinen SRL | Independent | 18,332 | 3,125 | |
| Castors Development SA2 | Independent | 20,000 | 5,000 | |
| Ahok BVBA | Independent | 20,000 | 5,000 | |
| Aubisque BV | Non-exec | 18,333 | ||
| P4Management BVBA | Non-exec | 20,000 | 2,917 | |
| NOSHAQ Partner SCRL | Non-exec | 19,021 | ||
| P. van Dijck | Non-exec | 20,000 | 5,000 | |
| Selva Luxembourg SA | Non-exec | 20,000 | ||
| Sunathim BV | Non-exec | O | O | |
| TicaConsult BV | Non-exc | 0 | 0 |
Following the issuance of the convertible bonds on December 10th 2020, the Company paid EUR 20 million in January 2021 to the former Uteron Sellers in accordance with the terms of the renegotiated agreement with respect to the payment terms and modalities of the Company's earn-outs payment obligation.
After the close of the financial year, on February 4, 2021, the Board of Directors of the company decided to appoint Mr. Leon Van Rompay as interim CEO until further notice, for a maximum of 12 months.
On March 2, 2021, Mithra announced the commercial launch of its vaginal contraceptive ring Myring® in Italy, the fourth largest market for contraceptive rings in the world after the United States, Germany and Spain, both in terms of commercial value and volume. With two million vaginal rings sold per year, the Italian market for contraceptive rings is worth 22 million euros per year, with a stable growth of 3% per year. The vaginal contraceptive ring of Mithra is commercialized in Italy by the company Farmitalia under the brand Kirkos®.
On March 8, 2021, Mithra and Searchlight Pharma announced the first worldwide approval for the new combined oral contraceptive Estelle® on the Canadian market, under the brand Nextstellis®, by the regulatory agency Health Canada. This is the first and only combination oral contraceptive product (COC) based on the unique native estrogen Estetrol (E4). E4 will be the first new estrogen-based COC to be marketed in Canada in over half a century, and the only COC alternative to ethinyl estradiol-based COC pills in Canada.
On March 26, 2021, Mithra and Gedeon Richter Plc. announced that they had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for a combined oral contraceptive (COC) consisting of Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. Subject to approval by the European Commission, marketing authorization valid in all EU member states is expected by the end of the second quarter of 2021.
On April 15 2021, Mithra and Mayne Pharma Limited announced that the US Food and Drug Administration (FDA) had approved the New Drug Application (NDA) for the novel combined oral contraceptive (COC) Estelle® under the trademark Nextstellis® (15 mg Estetrol (E4)/ 3 mg drospirenone (DRSP). Mayne Pharma anticipates the commercial launch of Estelle® by the end of June 2021.
| The Company has the following subsidiaries | 2020 Ownership % |
2019 Ownership % |
|
|---|---|---|---|
| Mithra Recherche et Développement SA |
100% | 100% | |
| Registered office | Rue Saint-Georges 5 4000 Liège |
||
| Incorporation Date | 13/06/2013 | ||
| Company registration n° | 534.909.666 | ||
| Neuralis SA | 100% | 100% | |
| Registered office | Rue Saint-Georges 5 4000 Liège |
||
| Incorporation Date | 1/07/2013 | ||
| Company registration n° | 0535.840.470 | ||
| Mithra Lëtzebuerg SA | 100% | 100% | |
| Registered office | Boulevarddela Petrusse 124, 2330 Luxembourg |
||
| Incorporation Date | 27/12/2012 | ||
| Company registration n° | LU25909011 | ||
| Mithra Pharmaceuticals CDMO SA | 100% | 100% | |
| Registered office | Rue Saint-Georges 5 4000 Liège |
||
| Incorporation Date | 13/06/2013 |
The Group's financial statements consolidate those of the following undertakings7 :
7 Please note that the shareholding percentage is considered at a consolidated level. Therefore, the 100% are held by the Company or one of its subsidiaries.
| The Company has the following subsidiaries | 2020 Ownership % |
2019 Ownership % |
|
|---|---|---|---|
| Company registration n° | 534.912.933 | ||
| Mithra Pharmaceuticals GmbH | In the process of liquidation |
100% | |
| Registered office | Promenade 3-9 Raumm 22 DE - 52076 Aachen Germany |
||
| Incorporation Date | 27/12/2013 | ||
| Company registration n° | DE 295257855 | ||
| Mithra Farmacêutica do Brasil Ltda | Liquidated | 100% | |
| Registered office | Rua Ibituruna N° 764 Saúde, São Paulo Brésil |
||
| Incorporation Date | 28/02/2014 | ||
| Company registration n° | NIRE N°35.220.476.861 | ||
| WeCare Pharmaceuticals BV | 100% | 100% | |
| Registered office | Lagedijk 1-3, NL -1541 KA Koog aan de Zaan |
||
| Incorporation Date | 23/09/2013 | ||
| Company registration n° | NL08165405B01 | ||
| Novalon SA | 100% | 100% | |
| Registered office | Rue Saint-Georges 5 4000 Liège |
||
| Incorporation Date | 17/11/2005 | ||
| Company registration n° | 877.126.557 | ||
| Estetra SRL | 100% | 100% | |
| Registered office | Rue Saint Georges, 5 4000 Liège |
||
| Incorporation Date | 01/09/2009 | ||
| Company registration n° | 818.257.356 | ||
| Donesta Bioscience BV | 100% | 100% | |
| Registered office | Boslaan 11 3701 CH Zeist The Netherlands |
||
| Incorporation Date | 23/12/2011 | ||
| Company registration n° | Commercial Register No, 54167116 |
The following associates are accounted for using the equity method in the Group's financial statements:
| The Company has the following associates | 2020 Ownership % |
2019 Ownership % |
|
|---|---|---|---|
| Targetome SA Registered office |
Avenue Pré-Aily 4, 4031 Angleur | 25,13% | 25,13% |
| Incorporation Date Company registration n° |
15/07/2010 827.564.705 |
As indicated, previously, the Company has decided to terminate the companies' activities and to initiate the legal proceedings related to the liquidation of the company so that its value was derecognized for the current financial year. Measures are being taken in this direction.
| In Euro (€) | |
|---|---|
| Auditor's fees | 159,434 |
| Fees for exceptional services or special missions (audit related) | 50,808 |
| Tax consultancy (audit related) | - |
| Fees for exceptional services or special missions (external to audit) | - |
| Tax consultancy (external to audit) | 44,015 |
| Total | 254,257 |
In accordance with Art. 105 of the Belgian Companies' Code (3:17 of the CCA), the condensed statutory standalone financial statements of Mithra Pharmaceuticals SA are presented. These condensed statements have been drawn up using the same accounting principles for preparing the complete set of statutory financial statements of Mithra Pharmaceuticals SAat and for the year ending 31 December 2020 in Belgian GAAP.
The statutory auditor, BDO Réviseurs d'entreprises, has issued a clean audit opinion on the statutory financial statements as at 19 April 2021.
The management report, the statutory financial statements of Mithra Pharmaceuticals SA and the report of the statutory auditor will be filed with the appropriate authorities and are available at the Company's registered offices.
| Thousands of Euro (€) | ||
|---|---|---|
| Assets as at | 2020 | 2019 |
| Fixed assets | 139,552 | 138,561 |
| Intangible fixed assets | 1,224 | 1,058 |
| Tangible fixed assets | 1,943 | 2,106 |
| Financial fixed assets | 136,386 | 135,397 |
| Current assets | 306,504 | 114,053 |
| Receivables | 66 | 66 |
| Amounts receivable | 178,931 | 67,034 |
| Inventory | 12 | 441 |
| Cash at bank and in hand | 123,111 | 41,249 |
| Deferred charges and accrued income | 4,384 | 5,308 |
| Total assets | 446,056 | 252,659 |
| Liabilities as at | 2020 | 2019 |
|---|---|---|
| Equity | 241,538 | 194,730 |
| Capital | 31,271 | 28,649 |
| Share premium account | 330,345 | 264,862 |
| Reserves | 598 | 598 |
| Accumulated losses | (120,676) | (99,378) |
| Provisions | 266 | 266 |
| Amounts payable after more than one year | 165,451 | 46,331 |
| Current liabilities | 38,802 | 11,237 |
| Current portion of long term debts | 26,193 | 1,187 |
| Amounts payable within one year | 12,297 | 10,125 |
| Deferred charges and accrued income | 313 | 21 |
| Total Liabilities | 446,056 | 252,659 |
| Thousands of Euro (€) | ||
|---|---|---|
| Summary income statement | 2020 | 2019 |
| Operating income | 17,930 | 17,642 |
| Turnover | 16,682 | 12,835 |
| Other operating income | 1,248 | 4,806 |
| Operating charges | 16,874 | 17,192 |
| Cost of goods sold | 463 | 4,325 |
| Services and other goods | 11,698 | 9,225 |
| Remuneration, social security costs and pensios | 2,947 | 3,221 |
| Depreciations of and amounts written off formation expenses, intangible and tangible fixed assets |
298 | 219 |
| Other operating charges | 1,468 | 202 |
| Operating profit | 1,056 | 450 |
| Financial result | (22,353) | (35,175) |
| Financial income | 2,152 | 815 |
| Recurrent financial charges | 4,428 | 317 |
| Non recurrent financial charges | 20,077 | 35,673 |
| (Profit) loss for the year before taxes | (21,297) | (34,725) |
| Taxes | 1 | - |
| Profit (loss) for the period available for appropriation | (21,298) | (34,725) |
| Capital statement | 2020 | 2019 |
|---|---|---|
| A, Capital | ||
| 1, Issued capital | ||
| - At the end of the previous year | 28,649 | 27,556 |
| - Changes during het year | 2,622 | 1,093 |
| - At the end of this year | 31,271 | 28,649 |
| 2, Capital representation | ||
| 2,1 Shares without par value | ||
| - Bearer and dematerialised | 42,714,097 | 39,133,245 |
| B. Own shares held by | N/A | N/A |
| C. Commitmentes to issue shares | ||
| D. Autorised capital not issued |
Mithra decided to use some alternative performance measures (APMs) that are not defined in IFRS but that provide helpful additional information to better assess how the business has performed over the period. Mithra decided to use REBITDA and EBITDA in order to provide information on recurring items, but those measures should not be viewed in isolation or as an alternative to the measures presented in accordance with IFRS.
REBITDA is an alternative performance measure calculated by excluding the non-recurring items and the depreciation & amortization from EBIT (operating loss) from the consolidated statement of income prepared in accordance with IFRS. The Group considers one-off item, share-based payments as non-recurring item above EBITDA and one-off item, impairment charges on Other intangible assets as non-recurring item below EBITDA.
EBITDA is an alternative performance measure calculated by excluding the depreciation & amortization from EBIT (operating loss) from the consolidated statement of income prepared in accordance with IFRS.
Refer to note on Financial Highlights and table below for the reconciliation to operating loss:
| Year ended 31 December | ||
|---|---|---|
| Thousands of Euro (€) | 2020 | 2019 |
| Operating profit/(loss) | (83,678) | 26,975 |
| Depreciation | 6,136 | 5,777 |
| Non-recurring items – impairment charges on Other intangible assets |
3,734 | - |
| Share-based payments | 7,267 | 4,898 |
| REBITDA | (66,540) | 37,650 |
| Share-based payments | (7,267) | (4,898) |
| EBITDA | (73,807) | 32,752 |

Rue Saint-Georges 5 4000 Liège Belgium +32 4 349 28 22 [email protected]
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