Annual Report • Mar 30, 2016
Annual Report
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INNOVATIVE NANOSCALE THERAPEUTICS
| This is Camurus |
1 |
|---|---|
| Key performance indicators | 2 |
| 2015 In brief |
3 |
| Statement from the CEO | 4 |
| Operating environment | 6 |
| Strategy |
7 |
| Technology platforms | 10 |
| Our development portfolio14 | |
| Marketing organisation | 18 |
| Employee portraits 20 |
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| Our development portfolio, cont21 | |
| Early R&D projects 26 |
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| Employees 27 |
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| The share 28 |
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| Sustainable development30 | |
| Glossary 32 |
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| Directors' report 34 |
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| Corporate governance report38 | |
| Risks 45 |
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| Consolidated statement of | |
| comprehensive income | 47 |
| Income statement – parent company47 | |
| Consolidated balance sheet | 48 |
| Balance sheet – parent company49 | |
| Consolidated statement of changes | |
| in equity 50 |
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| Parent company statement | |
| of changes in equity 50 |
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| Consolidated statement of cash flow51 | |
| Parent company statement of cash flow51 Notes 52 |
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| Assurance by the Board of Directors and CEO74 | |
| Auditor's report 75 |
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| Board of directors 76 |
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| Group management 78 |
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| Key figures and definitions | 80 |
Camurus is a Swedish research-based pharmaceutical company committed to developing and commercialising innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the proprietary FluidCrystal® drug delivery technologies and an extensive R&D expertise. Camurus' clinical pipeline includes products for treatment of cancer, endocrine diseases, pain and addiction. These are developed in-house and in collaboration with international pharmaceutical companies. The company's share is listed on Nasdaq Stockholm under the ticker "CAMX". For further information, visit www.camurus.com
Annual General Meeting ............................................................... ..81
Technology platforms FluidCrystal® injection Depot FluidCrystal® Topical Bioadhesiv FluidCrystal® Nanoparticles
CAM2038 Opioid dependence CAM2038 Pain CAM2029 Acromegaly CAM2029 Neuroendocrine tumours CAM2032 Prostate cancer In-house non-clinical projects
several collaborations on non-clinical projects
USD7bn
in annual sales products with same mode of action and indications, excluding pain.
| Key figures, SEK thousand | 2015 | 2014 | 2013 | 2012 |
|---|---|---|---|---|
| Net revenue |
154,799 | 208,207 | 197,716 | 95,204 |
| Operating result before items affecting comparability | -30,464 | 62,319 | 127,316 | 18,761 |
| Operating result | -204,104 | 62,319 | 127,316 | 18,761 |
| Result for the period | -159,542 | 48,346 | 99,235 | 13,317 |
| Cash flow from operating activities | -5,657 | 69,429 | 163,064 | 24,735 |
| Cash and cash equivalents | 716,096 | 56 | 5 | 3 |
| Total assets | 816,349 | 207,668 | 111,656 | 57,405 |
| Earnings per share before dilution, SEK | -6.33 | 2.06 | 17.01 | 2.28 |
| Earnings per share after dilution, SEK | -6.33 | 1.92 | 15.75 | 2.11 |
| Number of employees at end of period | 48 | 43 | 36 | 31 |
| Number of employees in R&D at end of period | 35 | 28 | 29 | 25 |
| Equity, SEK thousand | 640,557 | 123,457 | 50,047 | 40,210 |
| Equity ratio in Group, % | 78 | 59 | 45 | 70 |
| R&D costs as a percentage of operating expenses | 83 | 77 | 71 | 76 |
Two new research collaborations are launched with international pharmaceutical corporations focusing on new potential product candidates based on the FluidCrystal® injection depot.
Positive results are reported from two Phase 1 clinical trials comparing CAM2038 with a reference treatment consisting of daily administration of sublingual buprenorphine tablets.
A licensing and distribution agreement is signed with the Japanese company Solasia Pharma, pertaining to the distribution of episil® in Japan and China.
Novartis pays USD 2.5 million in R&D related milestone payments for CAM2029.
GMP manufacture of CAM2038 is completed ahead of the launch of pivotal Phase 3 trials.
The listing process is initiated for the Camurus' share on Nasdaq Stockholm.
All patients are included in a Phase 2 trial of CAM2032 for the treatment of prostate cancer.
An investigational new drug (IND) application for CAM2038 is submitted to the US FDA.
The FDA grants CAM2038 Fast Track status for the treatment of opioid dependence.
Scientific Advice is completed with the EMA with regard to the registration of CAM2038 in Europe.
The IND is approved for CAM2038 for the treatment of opioid dependence.
Novartis pays a further USD 2.5 million in R&D related milestone payments for CAM2029.
The Board of Directors of Camurus is reinforced with new Board members: Kerstin Valinder Strinnholm and Marianne Dicander Alexandersson.
A Phase 2 trial investigating the opioid blocking effects of CAM2038 is launched.
Global Phase 3 trials are launched for the use of CAM2038 to treat opioid dependence.
The Phase 2 trial of CAM2032 for the treatment of prostate cancer is completed.
Richard Jameson is appointed as Camurus' Chief Commercial Officer.
Camurus' share is listed on Nasdaq Stockholm on 3 December 2015.
A licensing agreement was signed with Rhythm Inc. regarding longacting setmelanotide FluidCrystal® for the treatment of genetic obesity.
Fast track-status from FDA for one of our most promising product candidates. Launch of Global Phase 3 trials. Promising collaborations on new exciting product candidates. Successful stock exchange listing. 2015 was a historic year for Camurus and a breakthrough for several of our products and advanced drug delivery technologies.
Among the most significant events of the year, I definitely count the successes achieved in the collaboration with our US partner, Braeburn Pharmaceuticals. Together with Braeburn Pharmaceuticals, and in close cooperation with the US and EU regulatory agencies, the FDA and EMA, we worked intensively through the year to actualise pivotal Phase 3 trials of our pioneering long-acting product candidate, CAM2038 – a product with the potential to become a game-changer in the treatment of opioid dependence.
In recent years, opioid dependence has reached such high proportions that it is now being referred to as an epidemic in the US. The situation is so serious that President Barack Obama chose to address the issue in his State of the Union speech in January 2016. The number of deaths related to opioid overdose continues to rise each year and is now close to 30,000 cases per year in the US alone.
There is an urgent need for new and improved treatment options, and there is much to be gained from safer and more effective treatments. Official figures indicate that for every single dollar spent on opioiddependency treatment, 12 dollars can be saved in the form of reduced medical and societal costs. Unfortunately, existing treatment options are also coupled to significant problems. Supply, illegal sales, abuse and in the worst case, lethal overdoses, follow in the trails of tablet treatments. Treatment adherence is also limited, since it is easy to dose incorrectly and to forget or intentionally refrain from taking the medication. Our long-acting product candidates can make a real difference here. With our CAM2038 depot under the skin, patients
are not burdened by daily medication procedures and the risks of misuse, abuse and diversion are eliminated.
CAM2038 is also developed to fulfil the considerable need for safe and effective treatments for chronic pain. In the US and Europe, chronic pain is estimated to affect more than 200 million people. Societal costs in terms of sick leave, healthcare and medications related to chronic pain are enormous. A clinical trial of CAM2038 in patients with chronic pain were launched at the beginning of this year. In parallel, preparations of a pivotal Phase 3 program was initiated in collaboration with Braeburn Pharmaceuticals.
In 2013, Camurus entered a licensing agreement with the Swiss pharmaceutical group Novartis on the further development and commercialisation of Camurus' long-acting octreotide product, CAM2029, for the treatment of acromegaly and neuroendocrine tumours (NET). Our mutual aim is to develop simplified and improved treatments for patients suffering from these rare and serious diseases. In 2015, two R&D milestones were achieved in this project, which resulted in a payment of USD 5 million from Novartis. During the year, a Phase 2 trial of CAM2029 was carried out in two groups of patients with acromegaly or NET. Trial results are expected in the second quarter of 2016. In parallel, Novartis is preparing pivotal Phase 3 trials for both of these indications, for which the market has steadily grown and in 2015 exceeded USD 2 billion.
During the year, we also completed a Phase 2 trial with CAM2032 for the treatment of prostate cancer. The product candidate is the first of its kind that is designed for easy administration by patients themselves. In addition to prostate cancer, CAM2032 also has the potential for treatment of precocious puberty and endometriosis. Under the framework of our collaboration agreement with Novartis, a Phase 1 trial of an undisclosed long-acting peptide product, CAM4071, was conducted during the year. Results from the trials with CAM2032 and CAM4071 are expected in the second quarter of 2016.
a new long-acting product candidate for the treatment of genetic obesity. This collaboration resulted in a new licensing agreement in the beginning of 2016. Shortly thereafter, Rhythm's setmelanotide program was granted Breakthrough Therapy status by the US FDA.
In early 2015, we took a strategic decision to list Camurus on the stock exchange in order to take advantage of the many potential uses and business opportunities for our technologies and products. This listing process was an intensive and inspiring process for our
Based on our FluidCrystal® technology, we have during the year also conducted a notable number of assessments of new product concepts in formulation and pre-clinical studies, targeting indications such as diabetes, nausea, inflammation and pain. We aim to take least one of these product candidates into clinical development during 2016. Furthermore, in collaboration with international biotech and pharmaceutical companies, we have performed evaluations of several drug compounds and new partnership opportunities. Of particular satisfaction in this regard was the successful collaboration with the US pharmaceutical company Rhythm on
management, employees, Board of Directors and advisors. Camurus was listed on Nasdaq Stockholm on 3 December, which resulted in several thousand new shareholders and an important capital injection of slightly more than SEK 500 million. To our and our shareholders' delight, the listing was followed by a positive share-price development in an otherwise turbulent market.
The primary objective of the listing was to create a solid foundation for further development and registration of our long-acting buprenorphine products, CAM2038, and
to build an own commercial infrastructure focused on the European opioid addiction market in anticipation of future market approvals. In December 2015, we announced the appointment of Richard Jameson to the position as Chief Commercial Officer with the responsibility for leading to leading this strategic endeavour. Richard has broad experience from different senior commercial roles across a number of specialty pharmaceutical companies and markets. Most recently, he was responsible for leading a commercial organization across Europe, the Middle-East and Africa focused on the opioid dependence field. A stepwise reinforcements of the commercial organisation will be made up until the expected product launch in 2018.
We stand well-prepared and positioned to implement all the components of our strategic plan: broaden our development pipeline, bring new pharmaceuticals to the market and prepare for the launch of CAM2038 in Europe. In parallel, we continue our forceful investments in innovation and technological development.
Finally, I would like to send a warm thanks to all dedicated colleagues and co-workers, partners, the Board of Directors and long-term shareholders, for your excellent collaboration and fantastic efforts during the year and to extend a warm welcome to all our new shareholders.
Lund, March 2016 Fredrik Tiberg , President and CEO
Growth in the pharmaceutical market is largely driven by an increasing proportion of patients suffering from chronic disorders and by a rapidly growing and aging population. At the same time, financing of healthcare is tightening, which continues to drive treatment effectiveness and cost-saving measures.
Demographic trends constitute a strong driving force in the global pharmaceutical market. According to the UN, the global population is expected to increase by nearly one billion over the next decade, to approximately 8.2 billion people in 2025. The number of individuals over the age of 60 is expected to more than double within the next 35 years, from 901 million in 2015 to about 2.1 billion in 2050.
The combination of an ageing population and increased access to better diagnostics, along with increasing occurrences of chronic diseases, is expected to drive market expansion in the developed world. Growth in these markets, particularly in the US, is also stimulated by launches of relatively high numbers of new medicines combined with fewer patent expirations for marketed medicines. Growth in emerging markets is expected to be driven primarily by increasing populations, improved access to healthcare and medicines, as well as various government-funded economic stimulus packages.
According to the IMS Institute for Healthcare Informatics' global forecast, the pharmaceutical market is expected to amount to USD 1,300 billion by 2018, representing an increase of about 30% compared with 2013.
Developed pharmaceutical markets are expected to account for USD 766–796 billion in 2018, an increase of about 23–28% compared with 2013. In the US, the key growth drivers are fewer patent expirations, implementation of the Affordable Care Act and to a limited degree price increases. In Europe, growth is expected to be moderate, due to austerity measures and the continued economic recession, as well as changes to benefit
systems and price cuts in some countries. The pharmaceutical markets in the developing nations are expected to grow with an increase rate of 50–60% from 2013 to 2018, to a market value of USD 358–388 billion.
Investments in R&D have increased sharply in the past 20 years among the 500 largest biotech and pharmaceutical companies, while the number of new approved pharmaceuticals has halved.
Historically, major pharmaceutical companies have undertaken the entire development process in-house, from R&D to commercialisation. Today, they are to a greater extent dependent on collaborations with researchbased biotech and pharmaceutical companies that usually are responsible for the research, innovation and initial development of product candidates. Suitable product candidates may subsequently be licensed to large companies that have resources to conduct large clinical trial programs and that have a broader commercial reach on the global market.
Joint ventures with licensing agreements allow for streamlining of the pharmaceutical product development from idea to market, and can reduce the risks for both parties by leveraging different positions of strength.
Licensing agreements often entitle the R&D company to down payments, milestone payments and royalties. Such agreements usually also include collaborations in which employees from both sides are involved in the development project. Other typical agreement factors may be joint marketing and sales, or exclusive rights in certain markets. Technology-related agreements may sometimes also cover multiple future product candidates.
Camurus is well positioned on the pharmaceutical market, with a clear focus on serious and chronic diseases, and with an R&D model based on well-documented active ingredients combined with own proprietary and worldleading drug delivery technologies. In addition, Camurus has several strategic partnerships with international pharmaceutical companies with leading positions within their own focus areas, and who retain commercial rights in markets where Camurus can efficiently undertake in-house marketing and sales. On the whole, this provides us with a broad revenue base that has the potential for major and longterm revenue generation, and a relatively balanced risk profile compared with the conventional development of pharmaceuticals based on new, original ingredients.
Read more about Camurus' technological platform on page 10 and the company's various collaborations on page 14.
Improve the quality of life for patients through simpler, smarter and safer pharmaceutical products
To be world-leading in advanced drug delivery systems and to provide innovative medical products that substantially improve the treatment of patients suffering from
Offer innovative and differentiated pharmaceutical products based on proprietary worldleading and patented drug delivery technologies, combined with active ingredients with clinical documentation on efficacy and safety
Camurus' goal is to develop and commercialise innovative and differentiated pharmaceutical products, based on the company's world-leading and patented drug delivery technologies.
Camurus' R&D is based on world-leading technologies and extensive expertise in the design and development of pharmaceuticals. We work in an open and flexible matrix organisation with expertise within pre-clinical, clinical, CMC and regulatory development, with a distinct overall objective – to make a difference for patients through modified and substantially improved treatments. Using our FluidCrystal® technology platform as a base, we have established a broad portfolio of product candidates in various development phases, from idea to pivotal Phase III trials. With our extensive investments in clinical development, we have verified our technologies in a large number of clinical trials. In parallel to these efforts, we continue to invest in new research and technological development to secure our leading position and create new market opportunities.
Our product development encompasses idea generation, formulation development and evaluation in pre-clinical studies, followed by a development phase with clinical trials and regulatory approval. By combining our patented technologies with active ingredients that have proven efficacy and safety profiles, Camurus creates new, patented medicines with enhanced properties for the treatment of disorders where there are distinct medical needs and favourable market conditions. The use of established pharmaceutical substances shortens development time and
facilitates the use of regulatory pathways such as the 505(b)(2) process in the US and the hybrid application in the EU. New products are developed in shorter time and at lower cost, compared with the development of entirely new pharmaceutical sub-
stances. Product development is facilitated by continuous improvements and the validation of our technologies, which arise as our most advanced pharmaceutical products advance toward approval.
To further increase our R&D capacity, spread development risks and enable efficient future commercialisation, we establish partnerships with other pharmaceutical companies that have complementary development and market resources, and the potential to establish a leading market position. This enables our technologies to be utilised more efficiently, and accelerates the development of our product pipeline. It also increases our geographic reach and the future market penetration of our products, while reducing costs of development and commercialization.
In order to utilise a greater share of the value of our innovations and our development of innovative product candidates, we retain rights to selected products in markets where the conditions for own commercialisation are favourable. One example of this is CAM2038 for the treatment of opioid dependence, where we recently commenced the establishment of an in-house commercial organisation initially focused on the European markets.
Our open, flexible and dynamic research environment with a distinct focus on the well-being of the patient is vital to the company's development and success. Stringent demands on quality and partnerships with leading international pharmaceutical groups and biotech companies are additional factors that enable an efficient and reliable development process.
Camurus' operations are built on innovation, development and commercialisation. Innovation emanates from our employees and their extensive experience from pharmaceutical development, supplemented by a solid base in biophysical chemistry, nanotechnology and clinical development.
VALUE CREATION IN THE DEVELOPMENT CHAIN
One vital component of Camurus' development strategy is to optimise the value potential of proprietary technology through partnerships, which also reduce the inherent risks in pursuing a small number of complex pharmaceutical projects. In general, the value and costs of a project increase as the clinical programmes advance to the market. To maximise the value development, Camurus retains the rights to its proprietary projects as long as possible, while utilising partnerships to increase development capacities aiming for areas and markets outside Camurus' commercial focus. Depending on the disease area, the size and costs of the clinical programme and the expected market dynamics, Camurus may undertake in-house late-stage clinical trials or engage a partner for parts of the clinical development.
Camurus' development and business model is based on identifying and developing new and improved treatments for patients suffering from serious and chronic diseases. Our unique and leading technology platform, FluidCrystal®, combined with active ingredients with welldocumented clinical efficacy and safety, enables efficient development of innovative and differentiated medicines with shorter lead times and lower risks compared with the development of new original pharmaceuticals.
Camurus has developed three technological solutions that are based on special combinations of polar lipids, i.e. specific fat molecules that have the ability to spontaneously form liquid crystal nanostructures in aqueous environments. The properties of these unique mixtures and structures enable a highly efficient encapsulation of pharmaceutical drug substances, which can then be released at a controlled speed over an extended period, while the lipid structures slowly degrade in the body. Another unique property of these liquid crystalline structures is that they can show strong adhesion to biosurfaces. The technologies are marketed by Camurus under the registered trademark FluidCrystal®.
New patented pharmaceuticals are developed by combining established drug substance with Camurus' FluidCrystal® technologies. Compared with medicines developed through traditional pharmaceutical R&D, there are several advantages with this process, such as shorter time to market, improved properties and efficacy, lower risk of failure in clinical trials and lower development costs.
By utilising active ingredients that are already approved, the development is simplified and streamlined and approval pathways such as 505(b(2) in the US or hybrid application in the EU may be used. Some of the information required for approval of the pharmaceutical through these processes, such as the safety and efficacy information of the active ingredients, may be derived from previously completed trials. Accordingly, time-consuming and costly development phases, such as comprehensive pre-clinical and toxicology studies and major clinical programmes, can be shorted and substantially reduced. Compared with traditional pharmaceutical development of a new active substance, which may take 10–15 years or longer, the lead time for a product submitted via the simplified regulatory pathway can substantially be shortened to about 5–8 years, depending on the indication.
Time and cost eective development process by combining documented compounds with a proven technology
FluidCrystal® injection depot
New generation of injection depot, compatible with prefilled syringes and autoinjectors.
FluidCrystal® topical bioadhesive
Extends and reinforces local treatment efficacy.
FluidCrystal® nanoparticles
Nanoparticle carriers increase bioavailability for small amphiphilic and lipophilic molecules, peptides and proteins.
13 4
Camurus' FluidCrystal® injection depot provides treatment efficacy over extended periods – from days to months – with a single injection. It reduces the burden of daily medication while increasing adherence to the therapy. FluidCrystal® is suitable for biological peptides as well as many small molecules.
FluidCrystal® injection depot comprises a homogeneous lipid-based liquid with a dissolved active ingredient that can easily be injected subcutaneously using a conventional syringe with a thin needle. Upon contact with fluids in the tissue, the lipid solution transforms into a liquid crystalline gel, which effectively encapsulates the active ingredient. The drug compound is subsequently slowly released at a controlled rate as the liquid crystalline matrix and lipid building blocks gradually degrade in the tissue. The release can be controlled, from several days to weeks or months, depending on the choice of lipid composition and other factors. The system's simplicity, including a spontaneous self-association to a functional structure in the body, eliminates complicated manufacturing procedures and the need for mixing prior to administration. Medicines based on the FluidCrystal® injection depot can easily be administered by the patients themselves or by healthcare professionals, without time-consuming and complicated reconstitution procedures. The long-acting
release and efficacy reduces the patient's burden of administering medication daily, improves the adherence to and results of the treatment, and improves the patient's quality of life.
Read more about Camurus' development products based on the FluidCrystal® injection depot: CAM2038 on p. 15, CAM2029 on p. 22 and CAM2032 on p. 24
Pharmacokinetic profiles (plasma concentration of pharmaceutical substance over time) following the administration of octreotide as an immediate-release aqueous solution contained in a FluidCrystal® injection depot. Octreotide is slowly released from the depot over 28 days, while injections of octreotide in aqueous solutions create an initial spike with increased concentrations that very quickly fall to subtherapeutic levels.
FluidCrystal® topical bioadhesive comprises a liquid product that forms a strong bioadhesive film after administration on tissue surfaces. The film functions as an invisible patch that slowly and precisely releases pharmaceutical substances systemically or locally. It also provides protection of sensitive and inflamed tissues. The formulation is suitable for prolonged local release of active ingredients on the skin and on mucosal membranes of e.g. the mouth, nose, throat and eyes.
The formulation is applied as a low-viscosity liquid on topical surfaces, where it spreads and transforms into a thin and strongly bioadhesive liquid crystalline film after absorption of minute amounts of water. The nanostructure of the film can be controlled to achieve an optimal delivery profile and bioadhesive strength. The formulation has a high solubilising capacity, which allows relatively small dosage volumes to achieve therapeutic effects with the active ingredient.
The commercial product, episil® is based on FluidCrystal® topical bioadhesive. Read more about episil® on page 25.
FluidCrystal® topical bioadhesive can be administered using metered dose pumps, tubes, capsules and other primary packaging forms for liquids.
FluidCrystal® nanoparticles can resolve the issue of bioavailability for water and fat-soluble pharmaceuticals or biodegradation-sensitive drugs, such as peptides and proteins.
FluidCrystal® nanoparticles are usually water-based and comprise a stable emulsion of nanoparticles with a liquid crystalline structure. Products based on this technology are administered either parenterally via injections or as a liquid sprayed onto the skin or mucous membranes.
Camurus' R&D aims to provide innovative medical products that change and substantially improve the treatment of patients suffering from serious and chronic diseases. We take outset in the needs of patients and healthcare providers in our pursuit to develop products that can make a real difference in the everyday lives through improved treatment results and long-term recovery.
Our drug delivery technologies and development expertise have provided a foundation for establishing, independently and through joint ventures, a broad portfolio of product candidates that address conditions with distinct and important medical needs, such as cancer, endocrine disorders, metabolic disorders, opioid dependence and pain. The product portfolio comprises both early product candidates investigated in pre-clinical studies and late-stage products under assessment in global and pivotal Phase 3 trials.
| PARTNER | Product | description | pre -clinical |
phase 1-2 |
phase 3 |
registration |
|---|---|---|---|---|---|---|
| CAM2038 q1w Opioid dependence |
Subcutaneous depot of buprenorphine for the treatment of opioid dependence. The product is intended for convenient administration by a healthcare professional once a week. |
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| CAM2038 q4w Opioid dependence |
Subcutaneous depot of buprenorphine for the treatment of opioid dependence. The product is intended for convenient administration by a healthcare professional once a month. |
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| CAM2029 NET |
Subcutaneous depot of octreotide for the treatment of neu roendocrine tumours (NET). The product comes in pre-filled syringes for easy administration, also by patients themselves. |
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| CAM2029 Acromegaly |
Subcutaneous depot of octreotide for the treatment of acromegaly. The product comes in pre-filled syringes for easy administration, also by patients themselves. |
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| CAM2038 q1w Chronic pain |
Subcutaneous depot of buprenorphine for the treatment of chronic pain. The product is intended for convenient administration by a healthcare professional once a week. |
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| CAM2038 q4w Chronic pain |
Subcutaneous depot of buprenorphine for the treatment of chronic pain. The product is intended for convenient administration by a healthcare professional once a month. |
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| CAM2032 Prostate cancer |
Subcutaneous depot of leuprolide for the treatment of prostate cancer. The product comes in pre-filled syringes with autoinjector compatibility for easy administration, also by patients themselves. |
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| CAM4071 Indication as yet to be published |
Opioid dependence is a chronic illness with frequent relapses into misuse. It represents a complex and globally growing health problem. About 15 million people are currently dependent on opioids, according to the WHO. 1 Of all forms of drug abuse, opioid dependence is currently the single largest burden to society.
In recent years, opioid dependence has reached epidemic proportions in the US. In 2014 alone, 29,000 deaths were reported as being due to opioid and heroin overdoses, corresponding to nearly 80 deaths per day, according to the US Center for Disease Control and Prevention (CDC). 2 About 5 million people abuse opioids or heroin every year in the US. 3 Approximately half of these are diagnosed with opioid dependence. Yet a smaller fraction is currently receiving medical treatment. Buprenorphine is currently the standard treatment in the US, with approxi mately 750,000 patients treated yearly. 4 On 17 September 2015, the US Secretary of Health, Sylvia Burwell, announced that measures had to be taken to increase patient access to buprenorphine treatment in order to meet the growing challenges in the wake of the ongoing epidemic of opioid abuse in the US. However, the increased access must be balanced with regard to potentially
increased risks of misuse, abuse and diversion.
In Europe, more than 1.3 million people are dependent on opioids, mainly heroin. 5 While the number of people addicted to heroin is quite stable, a growing number of individuals are becoming dependent on prescription opioid painkillers.5
"I have 30 years' experience from the pharmaceutical industry and have been involved in numerous partnerships and I put our partnership with Camurus at the top the list. Since joining forces to provide patients worldwide with access to CAM2038, we have launched four clinical trials and made considerable progress. The key is tight and constant communication – Fredrik Tiberg and I liaise regularly on a weekly basis. Our teams work in an energetic atmosphere with high levels of trust and spirit of collaboration. We and Camurus are both convinced that CAM2038 can change the lives of patients with opioid dependence and pain."
CAM2038 comprises two long-acting buprenorphine products developed for subcutaneous administration once weekly and once monthly, respectively. The products were designed for simple and safe administration by healthcare professionals. Both products come ready for use in pre-filled syringes equipped with an automatic needle guard device. Since CAM2038, in distinction to current buprenorphine products, does not require daily administration, the potential of treatment adherence is increased. The risk of relapse into abuse is accordingly reduced, which is a central aspect in the treatment of opioid dependence. Patients are also relieved of the trouble and stigma linked with daily, sometimes supervised, buprenorphine and methadone medication. Furthermore, the flexibility of different dosages and weekly or monthly injections enables individually tailored medication at all phases of treatment, from initiation and stabilisation to long-lasting maintenance treatment. Since the products will be administered by healthcare professionals, the risks of misuse, abuse, diversion and unintended paediatric exposure are eliminated. CAM2038 can also lead to significant savings for healthcare and society, since the number of patient visits for e.g. supervised administration is substantially reduced. The products are available in several dosages that are adjusted to cover approved doses of existing buprenorphine products.
Buprenorphine is currently the most used medication for the treatment of opioid dependence. Since its launch in the early 2000s, buprenorphine, in the form of sublingual tablets and films, has successively captured increasing market shares and is currently sold in more than 30 countries. In 2014, global sales of buprenorphine products for the treatment of opioid dependence totalled nearly USD 2.5 billion, with sales of nearly USD 2 billion in the US alone.7 Of this amount, more than 85% originated from a concentrated group of 5,000 prescribers. The number of patients treated with buprenorphine in the US is expected to continue to grow, from approximately 750,000 in 2015 to approximately 1.6 million in 2025.8
In Europe, slightly more than 700,000 patients receive medication-assisted treatment for opioid dependence, mainly methadone.5 The percentage of patients in Europe who receive buprenorphine treatment is currently estimated at slightly more than 25%, but is growing steadily with the addition of new patients without previous treatment histories.
To date, CAM2038 has been evaluated in three clinical trials, comprising a total of 188 people, of whom 176 were administered CAM2038. The products have showed a good safety profile and also demonstrated pharmacological and pharmacodynamic profiles consistent with weekly and monthly dosing.
6,0 6,2 7,3 9,5 10,6 11,7 12,9 15,8 17,8 18,919,7 21,3 21,9 CAM2038 was recently granted Fast Track designation by the US FDA for treatment of opioid dependence confirming the potential of CAM2038 to meet a large medical need in the treatment of a serious and lifethreatening disease. In December 2015, a randomised, double-blind Phase 3 efficacy trial was launched to study the effects of CAM2038 in patients with opioid dependence. In the trial, two parallel groups are treated with either long-acting subcutaneous buprenorphine (CAM2038) or daily sublingual medication. The trial includes
patients that are seeking, but not currently receiving, medical maintenance treatment. The Phase 3 trial is part of a comprehensive registration programme for CAM2038 that also includes a Phase 2 trial of the opioidblocking effects of CAM2038, and a Phase 3 long-term safety trial. Both trials were initiated during the last quarter of 2015.
The ongoing Phase 3 efficacy trial is expected to be completed before the end of 2016, with an expected submission for market approval in the US and Europe in 2017.
In November 2014, Camurus entered into a licensing agreement for CAM2038 with Braeburn Pharmaceuticals. Braeburn thereby obtained exclusive rights to CAM2038 for the treatment of opioid dependence and pain in North America, with option rights in Japan, Korea, Taiwan and China, while Camurus retained all rights in Europe and the rest of the world, including Australia.
1. UNODC, World Drug Report 2015
2. Center for Disease Control and Prevention 2015. http:// www.cdc.gov/nchs/data/health_policy/AADR_drug_ poisoning_involving_OA_Heroin_US_2000-2014.pdf 3. SAHMSA, Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health
4. Jones CM et al; Am J Public Health. 2015;105:e55-63. 5. EMCDD, European Drug Report Trends and Developments 2015. http://www.emcdda.europa.eu/ attachements.cfm/att_239505_EN_TDAT15001ENN.pdf 6. Birnbaum HG et al; Pain Med. 2011 Apr;12(4):657-67 7. IMS Health Data 2015 8. Braeburn presentation, JP Morgan Healthcare Conference 2016
The diagram compares observed (obs) plasma concentrations of four repeated doses of CAM2038 q1w with one single dose of CAM2038 q4w and seven doses of Subutex®. To facilitate comparison following repeated dosing with steady-state profiles, simulated curves based on predicted (pred) data are also shown. The diagram clearly indicates that buprenorphine plasma concentrations after single and repeated steady-state dosing lies within the same intervals as the sublingual reference product Subutex®, but without the daily variations in plasma concentrations that are seen for Subutex®.
CAM2038 can transform the treatment for opioid-dependent patients
CAM2038 will be the first longacting pharmaceutical for the treatment of opioid dependence on the European market. The product is deemed to have the potential to change the treatment and achieve improved treatment outcomes and longterm recovery, while reducing the stigma associated with current treatments of opioid dependence. CAM2038 also provides an opportunity to overcome some of the difficult and complex problems currently associated with other opioid-dependence treatments, including misuse, abuse and diversion.
In anticipation of a future market launch of CAM2038, Camurus has thoroughly assessed the conditions, dynamics and potential of the opioid-dependence market in Europe and other parts of the world. In contrast to
current pharmaceuticals which require daily administration, usually under supervision, CAM2038 only requires administration once a week or once a month, which gives patients more freedom and reduces the burden of frequent visits to various treatment centres. This makes CAM2038 particularly well adapted to the European market, since European countries usually require supervised distribution and intake, which may considerably impact the everyday lives of patients and their
quality of life. Greater treatment flexibility and reduced impact on daily life are factors that could increase patient adherence to treatment.1
CAM2038 also has the potential to generate healthcare savings by reducing the costs of treatment supervision, which constitutes a significant part of the total treatment cost. Improvement of treatment adherence and
reduction of dispersion, incorrect use and abuse are other benefits that could markedly impact both healthcare and social costs.2
With varying national guidelines and practices for the treatment of different patient categories, CAM2038's flexibility in dosage and dosing intervals make it an attractive future treatment option for opioid dependence in large parts of Europe. Our ambition is to make CAM2038 available to all patients with opioid dependence.
The market for opioid dependence in Europe is relatively stable, with about 1.3 million problem users, of whom the majority are addicted to heroin. More than 700,000 patients currently receive medical maintenance treatment.3 The market is expected to grow moderately in the next few years, mainly as a consequence of the growing use of opioid analgesics. Approximately 300,000 Europeans are estimated to be at high risk of becoming dependent due to the increasing use of prescription opioid painkillers.4
There is also an on-going paradigm shift on opioid dependence in Europe, where the traditional abstinence and harm-reduction treatment approaches are gradually changing towards an increasing recognition of opioid dependence as a chronic disease that requires long-term medical intervention in combination with psychosocial intervention. The focus is gradually shifting from the social consequences for society in terms of harmreduction, toward the long-term treatment outcome for the individual patient.5
Our ambition is to make CAM2038 available to all patients with opioid dependence " "
In a recent survey across the EU5 (n=253), a majority of surveyed medical specialists responded that they would be willing to prescribe CAM2038 to their opioid-dependent patients, provided that the therapy demonstrated efficacy, safety, and a tolerability profiles on par with existing buprenorphine products.6
Camurus has initiated the establishment of an efficient and highly specialised marketing and sales organisation for key European markets. The focus of this strategic investment is CAM2038 and the market for the treatment of opioid dependence, and Camurus' assessment is that CAM2038 constitutes a significant market opportunity.
In December 2015, we announced the appointment of Richard Jameson to the position as Chief Commercial Officer with the responsibility for leading this strategic endeavour. Richard has broad experience from different senior commercial roles across a number of specialty pharmaceutical companies and markets. Most recently, he was responsible for leading a commercial organization across Europe, the Middle-East
and Africa focused on the opioid dependence field.
In the initial phase, Camurus will focus on making CAM2038 available for patients who are either already receiving buprenorphine or who are going to commence medically assisted treatment for their opioid dependence. Our ambition is also to expand toward the methadone market over time, in order to utilise the advantages that CAM2038 can offer these patients.
The commercial organisation of Camurus will be set up to ensure coverage of all key stakeholders, initially for the execution of pre-marketing strategies in the early access markets. The organisation will then be expanded, prior to the anticipated time points of pricing and reimbursement approvals, for launch and sales in the respective countries. The organisation will be established in 3 phases.
| Country | Number of patients in substitution treatment3 |
% of patients who receive buprenorphine3 |
|---|---|---|
| UK | 172,000 | 27%1 |
| France | 163,000 | 66% |
| Italy | 94,000 | 15% |
| Germany | 77,300 | 21% |
| Spain | 69,000 | 3% |
| Nordic countries | 22,000 | 43% |
2016
reimbursed markets
1. Benyamina et al Heroin Addict Relat Clin probl 2012: 14(4): 65-80
4. Alho et al "Prevalence of prescription opioid-dependency in Europe and risk factors for abuse." Presented at the International Society of Addiction Medicine Annual Meeting 2013. Kuala Lumpur, Malaysia. 21–23 November 2013 5. UK Government 2010 Drug Strategy
6. Market Access Dynamics in Opioid Addiction: Decision Resources 2015
early reimbursed markets • General managers 2nd wave markets
• Regional leadership teams on 2nd wave markets • Full key account teams
When the European commercial organisation for CAM2038 is fully established around 2020–2021, it is expected to comprise between 70 and 120 people.
"At university, it was all about short projects for achieving new results and publishing in scientific journals, and then starting up the next project.
Here at Camurus, we conduct research with a long-term and distinct focus on the wellbeing of the patients.
It is rewarding to work in the pharmaceutical industry and to participate in research projects involving new products that could be of significant importance to people suffering from chronic diseases."
"Research is my great interest and an important part of my life. The environment and culture at Camurus allows me to grow as a researcher. I can contribute to new discoveries that advance scientific achievements and which are significant to society.
Innovative ability and progressive research is the foundation of Camurus' positive development.
To be a researcher at Camurus requires a solid scientific background and motivation. You must be willing to grow, be at the leading edge and be among the best in your field."
"Camurus is one of the most dynamic companies I have come across in my career. The ability to combine successful research and development with aggressive business development and commercialisation makes Camurus unique.
It feels exciting to participate in developing a marketing and sales organisation from scratch, with proprietarily developed products with the potential to truly improve treatment outcomes and the quality of life for patients suffering from serious and chronic diseases."
Chronic pain represents a global health problem and causes deterioration in general health, decreased capacity to work, reduced quality of life, and dependence and misuse of strong opioids.
The number of people suffering from chronic pain in the US is estimated to be 116 million.1 The associated societal costs, including the costs of health care and lost productivity, are estimated at USD 560-645 billion annually.1 In Europe, it is estimated that one in five adults suffers from chronic pain, corresponding to around 100 million people.2 Worldwide, the corresponding figure is estimated at 1.5 billion people. Chronic pain is one of the most difficult clinical challenges in medicine today, with limited treatment options available and a high unmet medical need. Opioids are recommended for the management of moderate to severe acute and chronic pain that cannot be adequately controlled by means of non-opioid analgesics. Opioids fill an extremely important role in the treatment of moderate to chronic pain, but the healthcare system also has to struggle with the risks and consequences of liberal prescription and high consumption of addictive opioids. The challenge is to provide efficient pain relief while minimising the risk of dependence and abuse. CAM2038 may be particularly well
suited for chronic pain patients with a history of misuse, since the subcutaneous route of administration and long-acting duration is expected to increase compliance and reduce the risks of incorrect use, even when compared to transdermal opioid formulations. The properties of CAM2038 are well matched to the target profile of chronic pain medications. CAM2038 provides a rapid onset and dose-proportional, long-term exposure without the risks of overdoses and respiratory depression that are associated with full muopioid-receptor-agonists, such as morphine, hydrocodone, oxycodone and fentanyl.
The global market for chronic pain exceeded USD 28 billion in 2010, of which post-operative pain and back pain accounted for USD 5.9 and 4.9 billion, respectively.3
Buprenorphine is currently available in injectable formulations to treat moderate to severe acute pain (e.g. Temgesic® and Buprenex®) and transdermal patches for chronic pain (e.g. BuTrans®/Norspan® from
Purdue Pharma/Mundipharma and Transtec® from Grünenthal). These products provide stable and relatively low buprenorphine concentrations over a period of seven and four days, respectively. Sales of BuTrans® in the US totalled USD 230 million in 2015.4 Endo Pharmaceuticals recently launched a new buccal buprenorphine product, BelbucaTM, and sales in 2019 are expected to exceed USD 250 million.5
On 22 February 2016, Camurus and Braeburn Pharmaceuticals announced the launch of a Phase 2 trial of CAM2038 in opioid-dependent patients with chronic pain. The primary objective of the trial is to evaluate pharmacokinetics after repeated administration of the weekly and monthly versions of CAM2038. The effects of CAM2038 on chronic pain and the safety profile, including local and systemic tolerance, are also being studied. In parallel to the implementation of the Phase 2 trial, preparations are under way for a pivotal Phase 3 trial of CAM2038 on the treatment of chronic pain, which is planned to begin after mid-year 2016.
1. Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education and Research. The National Academies Press, 2011. 2. Breivik H et al; Eur J Pain. 2006;10(4):287-333. 3. GBI research 2011 4. IMS Health Data 2015 5. Presentation by Endo Pharmaceuticals at JP Morgan-
Annual Healthcare Conference 2016
116 million
>28 USD billion global market for pain in 20103
CAM2038 KEY PROPERTIES FOR PAIN
Round-the-clock pain relief
~100 million
Somatostatin analogues (SSAs) represent the standard for safe and effective symptom control for patients suffering from acromegaly and neuroendocrine tumours (NET). SSAs have also demonstrated tumour-shrinking effects and are a treatment option for patients with unresectable NETs.
Acromegaly is a chronic hormonal disorder that occurs when the pituitary gland produces excess growth hormone. It is a rare disease that occurs in about 4 to 7 out of 100,000 individuals in the US and Europe.1 The clinical symptoms of acromegaly include progressive skeletal growth and soft tissue enlargement, mainly of the hands, feet and head. The disease is insidious and the onset usually occurs around middle-age. More than 90% of cases are due to the increased production of growth hormone in a benign pituitary tumour (pituitary adenoma). Acromegaly is associated with reduced quality of life, shortened life expectancy and an increased risk of fatal cardiovascular diseases.
NET is a heterogeneous group of rare tumours that can occur in many parts of the body. Most NETs are malignant and they commonly metastasise in lymph nodes and the liver. They can remain asymptomatic for years, only to be discovered at a relatively
late stage with symptoms of mass effect or metastases. Although functioning tumours result in distinct syndromes, individual symptoms are commonly non-specific, often leading to a delay in diagnosis of several years (five to seven years on average) and increasing the probability of metastatic disease.2 The incidence rate of NETs has significantly increased in recent years and is now estimated to be 5 per 100,000 per year, with an estimated prevalence of 35 per 100,000 in the US.3 CAM2029 contains the active ingredient octreotide, a synthetic analogue of the natural peptide hormone, somatostatin. The product is based on Camurus' patented FluidCrystal® injection depot and is developed to enable simple, safe and efficient treatment of acromegaly and NET. In comparison with current long-acting SSAs (Sandostatin® LAR® from Novartis and Somatuline® Autogel® from Ipsen) CAM2029 was developed for simple autonomous dosing by the patient.
Sandostatin® (Novartis) Somatuline® (Ipsen) *Compound annual growth rate
CAM2029 contains the active ingredient octreotide, a synthetic analogue of the natural peptide hormone somatostatin. The product is based on Camurus' patented Fluid-Crystal® injection depot and is developed to enable simple, safe and efficient treatment of acromegaly and NET. In comparison with current long-acting SSAs (Sandostatin® LAR® from Novartis and Somatuline® Autogel® from Ipsen) CAM2029 was developed for simple autonomous dosing by the patient. CAM2029 will be provided ready for administration in pre-filled syringes equipped with an automatic needle-stick prevention device, without the need for complicated mixing procedures prior to administration. There are also opportunities to further develop the product with an autoinjector for additional improvement of patient convenience. In addition to enabling simple self-administration, CAM2029 provides about 500% higher bioavailability compared with the market-leading Sandostatin® LAR®. This may potentially improve the treatment efficacy for patients with unsatisfactory responses to current treatments.
In the past 15 years, the SSA market has expanded with a CAGR of 13%.4 In 2015, global SSA sales totalled slightly more than USD 2 billion, of which Sandostatin® LAR® accounted for USD 1.63 billion and Somatuline® Autogel® for USD 382 million. The longterm growth of the market is dependent on factors such as increased awareness and diagnosis combined with an increased prevalence of NET.5 Future growth may derive from new potential fields of application for SSAs, such as retinopathy, nephropathy, obesity, polycystic kidney disease, pancreatitis and pancreatic fistulas.6,7,8
CAM2029 has been granted orphan designation by the EMA and FDA for the treatment of acromegaly. To date, CAM2029 has been studied in three clinical Phase 1 trials with both single and repeated doses, and in a recently completed Phase 2 trial of two patient groups with acromegaly and NET, respectively. More than 250 subjects participated in these three clinical trials, which also included Sandostatin® LAR® as a reference product. The Phase 1 trials demonstrated a rapid onset followed by a long-acting release of therapeutic levels of octreotide for about one month after the administration of CAM2029. A suppression of growth hormone levels in plasma, in the form of insulin-like growth factor-1 (IGF-1), which is an established biomarker for acromegaly, was also documented. The safety profile of CAM2029, including local tolerance, was positive in these trials.
The results from the recently completed Phase 2 trial of CAM2029 in patients suffering from acromegaly or NET, are expected in the second quarter 2016. Preparations for pivotal Phase 3 trials are also ongoing.
Camurus has an exclusive worldwide partnership with Novartis for the development and commercialisation of CAM2029 and other products based on Camurus' FluidCrystal®® injection depot. In addition to CAM2029, CAM4071 – another product in the partnership – is currently in clinical development. An ongoing Phase 1 trial is expected to be completed in 2016.
1. Chanson P et al; Orphanet J Rare Dis. 2008;3:17. 2. Modlin IM et al; Lancet Oncol. 2008;9:61-72. 3. Fraenkel M et al; Endocr Relat Canc. 2014;21:R153-163. 4. Medtrack
5. Hallet et al, Cancer. 2015 Feb 15;121(4):589-97 6. Rai U et al; Pharmacol Ther. 2015;152:98-110. 7. Woon C et al; BMC Nephrol. 2015;16:140 8. Jin K et al; Dig Surg. 2015;32:196-207.
Concentration of octreotide (left) and IGF-1 (right) in blood plasma after repeated doses of CAM2029 and Sandostatin® LAR®. CAM2029 provides a rapid onset of octreotide that continues to be released, with plasma levels exceeding above 1 ng/mL for the duration of one month following administration. The administration of CAM2029 provides about 500% higher bioavailability compared with the market-leading product Sandostatin® LAR®. The effect of an increased concentration of octreotide is reflected by reduced concentration of the growth factor, IGF-1. IGF-1 is a well-established surrogate biomarker for treatment efficacy in acromegaly patients. CAM2029, 10 mg CAM2029, 20 mg CAM2029, 30 mg CAM2029, 10 mg CAM2029, 20 mg
Hormone therapies for prostate cancer using gonadotropin-releasing hormone (GnRH) agonists such as leuprolide, are established therapies aimed at reducing the level of testosterone and thereby impeding the growth of cancer cells.
Long-term treatment with GnRH agonists results in regression of prostate tumours and symptomatic improvement among most patients. In comparative clinical trials on patients with metastatic prostate cancer, treatment with GnRH agonists has proven to deliver survival rates comparable with those obtained through surgical castration. GnRH agonists have also proven to be efficient in the treatment of other diseases, such as precocious puberty and endometriosis. CAM2032 is a long-acting leuprolide formulation for the treatment of prostate cancer. The product, which is based on Camurus' FluidCrystal® injection depot, is designed to provide patients with increased treatment flexibility by allowing the possibility of selfadministration in the home setting.
The market for GnRH agonists is dominated by long-acting injection products and has remained stable for some time, with total
global annual sales of USD 3–4 billion. However, the established products are unsuitable for self-administration and require preparation by healthcare professionals prior to administration. CAM2032, which was specially designed to enable self-administration, can provide patients with increased flexibility, while reducing the burden of scheduled injections by healthcare professionals.
A Phase 2 trial of single subcutaneous doses of CAM2032 in patients suffering from advanced metastatic prostate cancer demonstrated an intended pharmacokinetic and pharmacodynamic profile in the form of release of therapeutic levels of leuprolide and reduction in testosterone levels for one month following administration. CAM2032 also showed a favourable safety profile with excellent local tolerability. A second, Phase 2 trial of CAM2032 in patients with metastatic prostate cancer, was recently completed,
evaluating the product's pharmacokinetic, pharmacodynamic and safety profiles following repeated administration. In this trial, CAM2032 is also being compared with an active control product. The results of the Phase 2 trial will be available in the second quarter of 2016. CAM2032 is being developed in-house and Camurus has retained all development and commercialisation rights to the product.
1. Medtrack 2. http://www.cancerresearchuk.org/healthprofessional/cancer-statistics/worldwide-cancer/ incidence#heading-One
1.1 million
Fourth most commonly diagnosed form of cancer in the world, 20122
episil® is a medical device that was developed and registered on the European and North American markets by Camurus. The product comprises a bioadhesive lipid solution that protects and alleviates pain from inflamed and ulcerated mucous membranes in the mouth, including from oral mucositis. episil® has been tested in several clinical trials and the results have demonstrated that the product reduces pain in the mouth while also reducing the duration of oral mucositis. episil® has received market approval by the FDA, in accordance with the 510(k)pathway.
Oral mucositis is a painful inflammation and ulceration of the oral mucosa. It is a common side effect of radiotherapy and chemotherapy, affecting most head and neck cancer patients receiving radiotherapy and a large proportion, 30% to 75%, of patients undergoing chemotherapy for other cancer types, including breast cancer.1 In severe cases, oral mucositis may be treatment limiting, necessitating a reduction in dosage or postponement of therapy. Oral mucositis can in advanced stages be extremely painful, preventing the patient from eating and requiring hospitalisation for re-hydration, nutrient supply and opioid analgesia. Destruction of the protective oral mucosa also places the patient at a risk of infection.
Despite the development of various medications and targeted therapeutic interventions for the treatment of oral mucositis; a substantial medical need remains for effective pain control and for mitigation of the symptoms of the disease. The global oral mucositis market is estimated to exceed USD 700 million.2
episil® is currently marketed in Europe, the US and the United Arab Emirates. Sales and distribution are conducted through in-house marketing in Sweden, Denmark, Norway, the UK and Germany, and by several distribution partners in various countries. In 2015, Camurus signed a licensing agreement with Solasia Pharma K.K. for China and Japan. Registration work for these vital markets is ongoing.
V ÅR UT V ECKLIN G SPORTFÖLJ
1. Carulli et al, Hematol Rep. 2013 Jan 25; 5(1): 21–25. 2. GlobalData 2010
In addition to the products currently investigated in clinical trials, Camurus also has a number of new and promising product candidates in preclinical development. The projects are conducted in-house or in partnership with international biotech and pharmaceutical companies.
Camurus has several ongoing collaborations with biotech and pharmaceutical companies in preclinical evaluation phases, where the FluidCrystal® injection depot system is being evaluated together with various active ingredients. The projects include both marketed, patented active ingredients, where Camurus' collaboration project can be a part of the life-cycle management, and entirely new substances where Camurus' FluidCrystal® technology is included in the planned development strategy from start. Ongoing partnerships include new treatments for diabetes, obesity, viral infections and endocrine disorders.
Camurus' proprietary pipeline also comprises a number of promising internal product candidates in pre-clinical development, that are all based on the proprietary drug delivery technologies, FluidCrystal® injection depot or FluidCrystal® topical bioadhesive. The evaluation and selection of new product
candidates is conducted in accordance with a meticulously prepared process, where a number of key criteria are taken into consideration, such as the potential to fulfil unmet medical needs, technology matching, expeditious and efficient clinical development, opportunities for market exclusivity (including patent protection), as well as significant market potential for the product.
In the preclinical development phase, the product candidate is evaluated against the intended product profile, in terms of manufacture, stability and release in vitro and in vivo. The clinical, regulatory and market related aspects are concurrently evaluated. If the total evaluation is positive, technology transfer is initiated for clinical development, as well as the planning and start of the clinical trial programme. As a rule, simplified regulatory pathways such as 505(b)(2) in the US are utilised.
New products are often protected by existing technology patents, which are supplemented with new patent applications as new product specific innovations are
Medical needs
enhanced convenience, increased treatment adherence and/or healtheconomic advantages
• Patients and prescribers in focus
realised. An initial freedom-to-operate analysis is normally conducted when the product's properties have been made tangible and market analyses are then performed concurrently with the clinical and regulatory development processes.
Camurus has several product candidates in preclinical development that address
Key criteria for evaluation and selection of new product candidates
important medical needs within areas such as inflammation and pain (CAM2041), diabetes (CAM2046), cancer and supportive cancer care (CAM2047), and post-operative pain (CAM2048). Camurus intends to initiate clinical trials on at least one of these candidates during 2016.
At the end of 2015, Camurus had 48 employees. The majority work within R&D and hold advanced university degrees, including highly experienced senior researchers. At Camurus, we value diversity, equality and responsibility. There are currently seven nationalities represented among the company's employees, comprising 31 women and 17 men. Our operations are conducted from our head office in Lund, Sweden, with modern state-of-the-art laboratories and offices.
Camurus is a knowledge-based company where the knowhow, creativity and expertise of our employees is a key to continued success. Passion, knowledge and creativity are important qualities that enable us to attain our goals of offering patients and society new improved treatments for serious and chronic diseases. More than 70% of Camurus' employees work
in research and development. Our business and comprehensive expertises are developed through an active transfer of knowledge across an international network and through active collaborations with academia and industrial partners. This makes Camurus a dynamic and exciting workplace, with leading knowhow and expertise within several fields of research.
72% R&D 8% Administration 20% Business development marketing & sales
–Pharmaceutical development is all about solving many, and sometimes complex, challenges. It's exciting to work with new inventions and problem solving. For example, I was really pleased when I saw that we had succeeded in improving the stability of a sensitive peptide in one of our formulations.
I am passionate about developing effective cancer treatments. New treatments with fewer side effects can truly make a difference to people with cancer and increase their quality of life considerably.
I work in a very dynamic company with rapid processes, short decision-making paths and motivated researchers. The location at Ideon in Lund creates opportunities for close contacts with the most recent developments in research, which is a major benefit.
The Camurus' share was listed on Nasdaq Stockholm on 3 December 2015. The listing was the largest in the sector in nearly 10 years and was many times oversubscribed, following considerable interest from both institutions and private individuals.
Sustainability and a long-term view are prerequisites for the development of new pharmaceuticals. Camurus' founder and principal owner has worked patiently and intensively on the development and financing of a diverse and highly advanced pipeline comprising several attractive product candidates. The stock listing was a new, crucial step in the strategic move to make Camurus a long-term profitable pharmaceutical company, based on leading research and development. An efficient marketing and sales organisation is now being set up to promote medical products within the company's commercial focus on specialty pharmaceuticals for a concentrated customer group.
The successful listing on the stock exchange enables financing of the expansion of the project portfolio, advancing early stage projects to clinical-development and
in some cases all the way to the market. Importantly, it also enables Camurus to launch and commercialize own products, with a primary focus on the European market, where we have commenced the establishment of an in-house marketing organisation.
There was a large interest in Camurus IPO and it generated positive notice in the financial press as well as among investors. Several well-known entrepreneurs and institutions participated in the share issue and there was also a considerable interest from private individuals. At year-end, Camurus had slightly more than 3,000 shareholders.
Erik Hultgård – Analyst at Carnegie Peter Sehested – Analyst at Handelsbanken Capital Markets
Camurus share was listed at an initial price of SEK 57. At year-end 2015, the share price was SEK 74. During the period from 3 to 31 December 2015, the highest price paid was SEK 80 and the lowest was SEK 62.25. During same period, the share price rose 29.8%. At year-end, market capitalisation was MSEK 2,759, based on a closing price of SEK 74.
At 31 December 2015, Camurus had 37,281,486 registered common shares, corresponding to 37,281,486 votes.
At year-end 2015, Camurus AB had 3,358 shareholders, of whom 388, corresponding to 87%, comprised financial and institutional investors and 2,970, corresponding to 13%, comprised private individuals. Foreign shareholders accounted for 5.2% of the votes and capital. The ten largest shareholders accounted for 81% of the votes and capital.
At year-end, the share capital totalled SEK 932,037, divided by 37,281,486 shares with a quotient value of SEK 0.025. In accordance with the Articles of Association, the share capital may comprise a minimum of SEK 500,000 and a maximum of SEK 2,000,000, divided among a minimum of 20,000,000 shares and a maximum of 80,000,000 shares. Camurus' Articles of Association contains a record day provision and the company's shares are registered with Euroclear, where Euroclear Sweden AB administers the company's
shareholder register and registers the shares of individuals and organisations. All shares are entitled to an equal share in the company's profits and a percentage of the surplus in the event of liquidation.
In accordance with the dividend policy adopted by the Board of Directors, Camurus will continue to focus on further developing and expanding the company's clinical project portfolio and will also pursue commercial operations according to plan, and the available financial resources will be utilised for financing this strategy. Consequently, the Board of Directors does not intend to propose any dividend to shareholders until such time that the Company generates sustainable profitability. The Board of Directors proposes that the Annual General Meeting pass a resolution not to issue any dividends for the financial year.
| Numbers of shares |
% of capital |
% of votes |
|
|---|---|---|---|
| Sandberg Development AB | 20,014,978 | 53.69 | 53.69 |
| Swedbank Robur fonder | 3,129,608 | 8.39 | 8.39 |
| Tiberg, Fredrik | 1,512,551 | 4.06 | 4.06 |
| Catella Fondförvaltning | 954,677 | 2.56 | 2.56 |
| Backahill Utveckling AB | 877,193 | 2.35 | 2.35 |
| Gladiator | 877,193 | 2.35 | 2.35 |
| Grenspecialisten Förvaltning AB | 875,193 | 2.35 | 2.35 |
| Fjärde AP-Fonden | 703,879 | 1.89 | 1.89 |
| Skandinaviska Enskilda Banken S.a., W8imy | 676,019 | 1.81 | 1.81 |
| Enter Fonder | 491,500 | 1.32 | 1.32 |
| 30,112,791 |
| Number of shareholders |
Number of shares |
% of capital |
% of votes |
|
|---|---|---|---|---|
| 1 - 500 | 2,771 | 430,868 | 1.2 | 1.2 |
| 501 - 1 000 | 237 | 209,183 | 0.6 | 0.6 |
| 1001 - 5 000 | 202 | 496,919 | 1.3 | 1.3 |
| 5 001 - 10 000 | 41 | 321,000 | 0.9 | 0.9 |
| 10 001 - 15 000 | 23 | 287,082 | 0.8 | 0.8 |
| 15 001 - 20 000 | 12 | 219,272 | 0.6 | 0.6 |
| 20 001 - | 72 | 35,317162 | 94.7 | 94.7 |
| Total 2015-12-31 | 3,358 | 37,281,486 | 100,00 | 100,00 |
| % of votes |
% of capital |
Number of shareholders |
Number of share |
|
|---|---|---|---|---|
| Swedish Institutions | 82.0 | 82.0 | 327 | 30,574,390 |
| Foreign Institutions | 5.0 | 5.0 | 61 | 1,857,959 |
| Swedish private shareholders | 12.8 | 12.8 | 2,944 | 4,780,366 |
| Foreign private shareholders | 0.2 | 0.2 | 26 | 68,771 |
| 100.0 | 100.0 | 3,358 | 37,281,486 |
1) Euroclear Sweden. In the table ownership details may be merged with several items from Euroclear´s statistics. The merger is intended to show an institution or individuals total ownership in Camurus.
At Camurus, sustainability is a natural part of what we do and produce, and is included as a vital aspect of our Code of Conduct and operations.
Our mandate is to improve the lives of patients suffering from serious and chronic diseases, by providing significantly improved treatment solutions. In our efforts to develop new pharmaceutical products, we hold a continuous dialogue with a range of stakeholders, including healthcare professional, patients, legislators, regulatory authorities and insurance companies. We maintain discussions and collaboration throughout the product's life cycle, from the start of development to the clinical trial phases and market registration, and onward to marketing and sales. Through effective collaboration with key stakeholders, we offer long-term sustainable treatment options to the delight of patients, healthcare, society and our employees.
Camurus continuously strives to offer a secure and safe work environment where nobody is exposed to unnecessary risks. We integrate safety and health aspects in everything we do. Camurus has adopted guidelines and procedures for facilitating safety at the workplace. Employees are expected to manage risks in a responsible way and to only perform tasks for which they are suitably trained. Employees are to immediately report any environmental or safety risk to their immediate superior. At Camurus, we pursue research and development in an environmentally responsible manner to minimise the environmental impact of our developmental work and our products, and to reduce waste and adopt energy-saving measures. An example of how our research and development work benefits the environment is that several of our product candidates have been designed to provide equivalent or improved efficacy with a volume of active pharmaceutical substances that is several times smaller compared with current treatment options, which reduces the environmental footprint and spreading of such substances. Furthermore,
Camurus' long-acting pharmaceuticals, which in suitable cases may also be personally administered by the patients themselves, potentially reduce the need for clinic visits and thereby reduce the need for travel and transportation to and from treatment clinics. To the furthest extent possible, we also endeavour to use eco-friendly ingredients and transportation, and to establish regional supply chains where possible.
Camurus develops new and innovative pharmaceuticals and medical products with the ultimate goal of improving the quality of life and treatment outcomes for patients. Clinical research and clinical trials for evaluating the safety and efficacy of products designed for the treatment and prevention of diseases, are crucial components of pharmaceutical development. Camurus aims to consistently maintain high ethical standards in pursuit of its research and development operations. We commit ourselves to protect patients and the healthy volunteers who participate in our clinical trials; to ensure that we uphold the highest ethical, scientific and clinical standards in all our research; and to
provide the results of our studies on time and in an objective, precise and complete way. All the data from our clinical research is registered, processed and stored in a manner that facilitates thorough reporting, interpretation and verification.
Patient safety is Camurus' highest priority. In our research and development, manufacture, storage, distribution and market-research activities, we follow all applicable laws and ordinances, including the disclosure of safety information aimed at guaranteeing the safety and quality of our pharmaceutical products. We consistently keep to our internal guidelines and procedures, which are aimed at protecting patient safety and ensuring quality in our products. We track and monitor products that are available in the market with respect to side effects and new and unexpected safety signals, and we notify regulatory bodies about such data in accordance with applicable rules and regulations. Every employee is responsible for reporting any side-effects with respect to pharmaceuticals in the clinical trial phase and our existing products in the market.
Camurus is committed to impose the highest requirements on integrity and honesty, and to adhere to all applicable laws, ordinances and guidelines with regard to all its interaction with healthcare and medical providers and professionals. There must be a justifiable need for utilising the services of healthcare professionals or organisations, and the same applies to any compensation for services rendered. Compensation may only be paid if there is a written agreement detailing the service rendered. The fee for such a service may not exceed regular market levels. Camurus is committed to provide truthful, non-misleading and correct information about the approved areas of application of our products and we do not offer or promise any form of compensation or gifts to influence purchasing decisions. Patients and healthcare professionals are entitled to make decisions about the best medical care based on truthful, fair, corroborated and scientifically rigorous statements.
Camurus operates within a strictly regulated industry. Government regulatory bodies routinely demand information through audits, evaluations and inspections. All employees shall always act honestly and professionally in all contact with representatives of government agencies.
Camurus' suppliers play an important role in our research, development and sales of pharmaceuticals. We consistently select our suppliers based on objective criteria and with the expectation that they act in a manner that corresponds to our commitment to adhere to applicable laws and ethical business practices. Our suppliers are reviewed and inspected regularly, in accordance with all relevant and applicable regulatory frameworks.
Our Code of Conduct guides our efforts against corruption and bribery. Employees or third parties who act on behalf of Camurus are never to make a payment or provide a benefit with the intention of exerting improper influence, or that may appear to exert influence, on a business decision.
Acromegaly A disorder caused by overproduction of growth hormones resulting in abnormal body growth
Agonist A drug or other substance that binds to and blocks a receptor and thereby stimulates the activity of the receptor
Analogue Similar molecular structure
Androgen Male sexual hormone
Antagonist A drug or other substance that binds to and blocks a receptor without stimulating the activity of the receptor
Bioadhesive A substance that is adhesive to biological surfaces
Bioavailability The degree and rate at which a substance (as a drug) is absorbed by the body
Buprenorphine Active ingredient that is strongly analgesic and that may be used for treatment of opioid dependence
CAGR Compounded Annual Growth Rate, average annual growth
Cash pool Cash management technique employed by companies
CE marking CE marking of a product is used within the EU/EEA to show that the manufacturer or importer has followed the essential requirements regarding safety, health, performance etc. that are outlined in the applicable EU directives
CHMP Committee for Medicinal Products for Human Use, the committee at EMA that is responsible for preparing opinions on questions concerning medicines for human use
Clinical trials Investigations performed in humans in order to study the properties of an investigational product
COWS Clinical Opiate Withdrawal Scale, a scale used for clinical evaluation of withdrawal symptoms caused by opiates
CSA US Controlled Substances Act of 1970
DATA 2000 US Drug Addiction Treatment Act of 2000
DEA US Drug Enforcement Administration
Dispersion Dissemination or distribution of a substance
EEA European Economic Area
EMA European Medicines Agency, a decentralized agency of the EU, responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU
Endocrine diseases Diseases affecting the endocrine system, i.e. the body's production, secretion and response to hormones
Endometriosis A disease in which tissue that normally grows inside the uterus (endometrium) grows outside the uterus
EU4 France, Germany, Italy and the United Kingdom
EU5 France, Germany, Italy, the United Kingdom and Spain
EudraCT European Union Drug Regulating Authorities Clinical Trials, the EU database for clinical trials
FDA Food and Drug Administration, the US food and drug authority
FDCA Federal Food, Drug and Cosmetic Act
Gauge The dimension of the outer diameter of an injection needle. The gauge value decreases when the outer diameter increases
GCP Good Clinical Practice
Generic drug A drug that has the same active ingredient as a brand name drug
GMP Good Manufacturing Practice
GnRH Gonadotropin-Releasing Hormone
IFRS International Financial Reporting Standards
IGF-1 Insulin-like Growth Factor 1
In situ On site, in position
In vitro Biological process that takes place outside a living cell or organism
In vivo Biological process that takes place in living cells and tissues in an organism
Incidence Number of new cases per population at risk
IND Investigational New Drug, classification that is required for development of a new drug in the US
Intramuscular Injection of a drug in a muscle, e.g. the gluteal muscle injection
Intravenous Injection of a drug into a vein injection
Leuprolide Active ingredient used for treatment of e.g. prostate cancer
Lipids Group of compounds consisting of fat or fat-like substances
MAA Marketing Authorisation Application, application for marketing authorisation of a drug within the EU/EAA
Milestone payment Economic compensation obtained within a framework of a partner program when a specific goal has been achieved
Morbidity The incidence of a disease within a population
Mortality The incidence of death or number of deaths within a population
Naloxone Active ingredient used as an antidote to reverse respiratory depression after opioid or opiate overdoses
Nanoparticle Microscopic particle that behaves as a whole unit
NDA New Drug Application, application for approval from the FDA to commercialise a new drug in the US
NET Neuroendocrine tumours, a group of different kinds of hormone producing tumours
Octreotide Active ingredient used for treatment of e.g. cancer
Oral mucositis Inflammation of the oral mucosa that leads to ulcers and pain in the oral cavity
Orphan drugs Drugs intended to treat serious or life-threatening diseases that are so rare that pharmaceutical companies are reluctant to develop them for economic reasons
Peptide Molecule consisting of a chain of amino acids
Pharmacodynamics The biochemical and physiological effects of a drug on the body
Pharmacokinetics The fate of a drug within the body (i.e. the absorption, distribution, metabolism and excretion) Pharmacovigilance System for detection, assessment, understanding and prevention of adverse effects and other drugrelated problems
Pre-clinical studies Studies performed in model systems, i.e. not in humans
Prevalence The proportion of a population that is affected with a particular disease or condition
Reconstitution Preparation of a drug before administration, often addition of a diluent to a powder
SOWS Subjective Opiate Withdrawal Scale, a scale used for subjective evaluation of withdrawal symptoms caused by opiates
SSA Somatostatin Anologues, the standard for safe and effective medical therapy for acromegaly and symptom control in NETs
Subcutaneous Injection of a drug under the skin injection
Sublingual Under the tongue
the Directive Directive 2001/83/EC of the European Parliament and of the Council of 06 November 2001 on the Community code relating to medicinal products for human use
Toxicity The degree to which a substance is toxic
Transdermal A route of administration wherein active ingredients are delivered across the skin for systemic distribution, e.g. via patches or ointments
Viscosity A measure of how viscous or thick a fluid is
WHO World Health Organization
| Directors' Report 34 | |
|---|---|
| Corporate Governance Report 38 | |
| Risks 45 |
| Consolidated statement of comprehensive | |
|---|---|
| income 47 | |
| Income statement – parent company 47 | |
| Consolidated balance sheet 48 | |
| Balance sheet – parent company 49 | |
| Consolidated statement of changes in equity 50 | |
| Parent company statement | |
| of changes in equity 50 | |
| Consolidated statement of cash flow 51 | |
| Parent company statement of cash flow 51 |
| Note 1 General information 52 | |
|---|---|
| Note 2 Summary of key accounting policies 52 | |
| Note 3 Financial risk management 59 | |
| Not 4 Important estimates and assessments 60 | |
| Not 5 Segment information61 | |
| Not 6 Expenses divided by type of61 | |
| Not 7 Other operating income 62 | |
| Not 8 Audit fees 62 | |
| Not 9 Expenses for employee compensations 62 | |
| Not 10 Finance income and expenses 63 | |
| Not 11 Income tax 63 | |
| Not 12 Earnings per share 64 | |
| Not 13 Exchange rate differences 64 | |
| Not 14 Intangible assets 64 |
| Not 15 Property, plant, and equipment 65 | |
|---|---|
| Not 16 Deferred tax 65 | |
| Not 17 Interests in Group companies 66 | |
| Not 18 Financial instruments per category 67 | |
| Not 19 Parent company's transactions | |
| with principal shareholder 67 | |
| Not 20 Trade receivables 67 | |
| Not 21 Prepayments and accrued income 68 | |
| Not 22 Cash and cash equivalents 68 | |
| Not 23 Share capital and other | |
| contributed capital 68 | |
| Not 24 Share-based Payment 69 | |
| Not 25 Accruals and deferred income 70 | |
| Not 26 Leases 70 | |
| Not 27 Other non-cash items 70 | |
| Not 28 Related party transactions 70 | |
| Not 29 Items affecting comparability 72 | |
| Not 30 Events after the balance sheet date 73 | |
| Assurance of the Board of Directors | |
| and President74 | |
| Auditor's report 75 | |
| Board of directors 76 | |
| Group management 78 | |
| Key figures and definitions 80 | |
| Annual General Meeting 81 |
The Board of Directors and Chief Executive Officer of Camurus AB (publ), with its registered office in Lund and company registration number 556667-9105, hereby present the Annual Report for the 2015 financial year, for the Group and the Parent Company. The annual accounts, corporate governance report and the auditor's report are presented on pages 34-75. The earnings from the year's activities and the Parent Company's and the Group's financial position are presented in the director's report and the subsequent income statement and balance sheet, comprehensive income statement, statement of cash flow, statement of changes in equity as well as supplementary disclosures and notes, all of which collectively constitute the annual accounts.
Camurus is a research-based pharmaceutical company with a focus on the development and commercialisation of new and innovative pharmaceuticals for serious and chronic diseases, where there are clear medical needs and the potential to significantly improve treatment. The company's research portfolio comprises late-stage product candidates for treating cancer and the side effects of cancer treatment, endocrine disorders and pain, as well as drug addiction.
In anticipation of the market approval of Camurus' longacting buprenorphine (weekly and monthly products), CAM2038, the company has launched a process to build an in-house commercial organisation with an initial focus on the European markets for opioid dependence. The CAM2038 products have the potential to transform the treatment of opioid dependent patients with prospects of improved treatment outcomes and long-term recovery, while reducing the stigma associated with current treatments of opioid and heroin dependence. CAM2038 also presents the opportunity to overcome some of the difficult and complex problems associated with current daily treatments of opioid dependence, including misuse, abuse and diversion.
To develop new and improved pharmaceuticals Camurus uses its advanced drug delivery technologies, such as the longacting FluidCrystal® injection depot technology. By combining these proprietary technologies with active ingredients, that have proven clinical efficacy and safety profiles, new patented medicines with improved properties and treatment results can be developed in shorter time and at significantly lower costs and risks compared with the traditional development of pharmaceuticals based on new drug substances. In addition to several products in an advanced clinical development phase, including the treatment of opioid dependence, acromegaly and neuroendocrine tumours, Camurus is also developing a number of pre-clinical projects. Product candidates are developed in-house or in collaborations with international pharmaceutical and biotech companies.
In addition to pharmaceuticals, Camurus has also developed and launched a medical device under the trade name of episil® in markets in Europe, the US and the Middle East, where marketing and sales are conducted through partners and a small own sales force.
• Two new collaboration projects initiated with international pharmaceutical corporations.
• License- and distribution agreement signed with Solasia Pharma regarding episil® in Japan and China.
Research and development are key strategic priorities for Camurus. The company's long-term success is highly dependent on continuing innovation and the development of technologies as well as new and important pharmaceutical products. Camurus currently has, either itself or together with partners, six projects that are in the clinical development and a number of projects in pre-clinical development.
Camurus' research and development organisation includes pre-clinical, pharmaceutical and analytical, as well as clinical and regulatory functions. The company's research and development expenditure in 2015 amounted to MSEK 153.1 (MSEK 114.1 in 2014), corresponding to 83 percent (77 percent in 2014) of operating expenses before items affecting comparability.
CAM2029 is a subcutaneous depot of octreotide, which is being developed for the treatment of patients with acromegaly or neuroendocrine tumours (NET). CAM2029 is being developed by Novartis, as a new treatment option to the current market leader Sandostatin® LAR®.
At year-end 2015, Camurus and its partner Novartis, were in the process of completing a Phase 2 pilot study in patients with acromegaly and NET. The last patients exited the trial in the first quarter of 2016 and the results are expected in the second quarter of 2016. In parallel, Novartis is preparing GMP manufacturing of CAM2029 for start of Phase 3 trials in patients with acromegaly and NET.
CAM2038 includes subcutaneous weekly and monthly depots of buprenorphine, which are being developed by Camurus and its partner Braeburn Pharmaceuticals, for the
| PARTNER | Product | descripti on |
pre-clinica l |
pha se 1/2 |
pha se 3 |
regi strati on |
|---|---|---|---|---|---|---|
| CAM2038 q1w Opioid dependence |
Subcutaneous depot of buprenorphine for the treatment of opioid dependence. The product is intended for convenient administration by a healthcare professional once a week. |
|||||
| CAM2038 q4w Opioid dependence |
Subcutaneous depot of buprenorphine for the treatment of opioid dependence. The product is intended for convenient administration by a healthcare professional once a month. |
|||||
| CAM2029 NET |
Subcutaneous depot of octreotide for the treatment of neuro endocrine tumours (NET). The product comes in pre-filled syringes for easy administration, also by patients themselves. |
|||||
| CAM2029 Akromegali |
Subcutaneous depot of octreotide for the treatment of acromegaly. The product comes in pre-filled syringes for easy administration, also by patients themselves. |
|||||
| CAM2038 q1w Kronisk smärta |
Subcutaneous depot of buprenorphine for the treatment of chronic pain. The product is intended for convenient administration by a healthcare professional once a week. |
|||||
| CAM2038 q4w Kronisk smärta |
Subcutaneous depot of buprenorphine for the treatment of chronic pain. The product is intended for convenient administration by a healthcare professional once a month. |
|||||
| CAM2032 Prostatacancer |
Subcutaneous depot of leuprolide for the treatment of prostate cancer. The product comes in pre-filled syringes, with autoinjector compatibility, for easy administration, also by patients themselves. |
|||||
| CAM4071 Indication as yet to be published |
treatment of opioid dependence. The products, which were granted Fast Track designation by the US FDA, are designed to address a number of shortcomings in the existing daily administered medicines, including inadequate patient compliance, extensive misuse, abuse and diversion, as well as frequent opioid use relapses.
In late 2015, global Phase 3 trials were launched to document the efficacy and long-term safety of CAM2038 on opioid-dependent patients. The trials include a randomized, double blind, active controlled, 6-month efficacy study and a 12-month safety study. A pivotal Phase 2 trial of the opioid blocking effects of CAM2038 was also started in the fourth quarter. These trials are part of the pivotal clinical programme discussed with the FDA and EMA. The aim is to complete the Phase 3 efficacy trial and the Phase 2 trial during 2016.
In addition to treatment of opioid dependence, weekly and monthly depots of CAM2038 are also being developed for the treatment of chronic pain.
Before year-end 2015, a Phase 2 protocol was submitted to FDA. The trial is designed to assess pharmacokinetics and effects on pain, as well as safety and local tolerability, after repeated doses of CAM2038 in opioid-dependent patients suffering from chronic pain.
CAM2032 is a new, subcutaneous leuprolide depot product that is being developed by Camurus for the treatment of prostate cancer.
CAM2032 is being evaluated in patients with advanced metastatic prostate cancer in a Phase 2 trial that includes Eligard® as the active control. The trial was clinically concluded in the fourth quarter when the last patients completed treatment. Results of the trial will be presented in the second quarter of 2016.
Camurus is evaluating several product candidates in the preclinical phase. The studies include formulation optimisation with regard to release and stability, as well as pharmacological, toxicological and safety-related properties pertaining to the product's target profile. Analyses of medical needs, the initial pricing and market conditions are being conducted in parallel.
In late 2015, four new, promising product candidates were evaluated in different pre-clinical trials, showing positive results with regard to pharmacokinetics and local tolerability. Areas of indication for pre-clinical product candidates include diabetes, inflammation and pain. Based on the achieved results, priorities are made in preparation for the documentation of toxicological safety studies that will be launched in early 2016. Clinical trials of at least one prioritised product candidate are planned to start in 2016.
Camurus is also pursuing collaborative work with various pharmaceutical companies regarding the development of new product candidates based on Camurus' Fluid Crystal® drug delivery technology and the partner company's proprietary drug compound. These collaborations involve formulation development and addressing various pharmacological properties with respect to pre-determined technical and market-related product objectives.
At year-end 2015, there were half-a-dozen collaborative projects ongoing with different pharmaceutical companies, targeting cancer, obesity, diabetes and HIV indications.
episil® is a medical device that is used to treat inflammatory and painful conditions in the oral cavity. The product provides rapid pain relief and protection in cases of blisters and sores in the mouth, and for serious inflammatory conditions, such as oral mucositis, which is a serious and frequently occurring side-effect of cancer treatments.
Camurus' partner, Solasia Pharma, has initiated the process to register episil® in China and Japan. Camurus has also initiated sales of episil® in Germany, where a new 3 mL product was recently launched.
In 2015, the Group's net revenue amounted to MSEK 154.8 (208.2) and primarily comprised license related payments (from Novartis, Braeburn Pharmaceuticals and Solasia) as well as project related incomes. The difference in revenues compared with the preceding year is mainly attributable to the upfront payment received on the signing of the licensing agreement with Braeburn Pharmaceuticals in November 2014.
Camurus' marketing and sales costs during the year amounted to MSEK 19.4 (11.4), corresponding to an increase of 70 percent. The increase was attributable to a MSEK 1.8 cost reallocation, primarily between administrative expenses and marketing and distribution costs, which was implemented with the aim of providing a more accurate view of the cost allocation between various functions. Furthermore, the increase is mainly linked to expenses for an outsourced sales force for episil® in the UK and Germany, and to expenses pertaining to the company's general growth.
Administrative expenses for the year amounted to MSEK 11.9 (22.2). However, for a fair comparison, administrative expenses would have totalled an additional MSEK 12.2 if there had not been a redistribution of administrative expenses between marketing and distribution costs and research and development costs. The underlying increase pertains to the company's general growth. Research and development costs amounted to MSEK 153.1 in 2015, compared with MSEK 114.1
in 2014, corresponding to an increase of 34 percent. The increase was mainly attributable to intense activity in the leading development programmes and to expenses for clinical trials. However, MSEK 10.4 is attributable to the redistribution of costs between administrative expenses and research and development costs.
Other income during the year amounted to MSEK 0.06 (2.5) and the difference compared with the preceding year comprised exchange gains. Other expenses amounted to MSEK 0.7 (0) and comprised exchange losses.
The operating result before items affecting comparability was negative MSEK 30.5, compared with a profit of MSEK 62.3 in 2014, with the difference essentially attributable to the licensing agreement signed with Braeburn Pharmaceuticals in the preceding year. Camurus' operating result was negative MSEK 204.1 (profit: 62.3). In conjunction with the company's stock-exchange listing, employees and Board members received shares in Camurus. A total of 1,909,483 shares were allotted and the total impact on earnings during the year amounted to MSEK 108.9 after tax, with a corresponding
increase in equity of MSEK 108.8 and a social security cost of MSEK 30.8. The terms of the share bonus program have now been met in full and no additional costs will be charged against Camurus' earnings under this program. For further information, see Note 24. Further, the result were also charged with MSEK 26.5 after tax, pertaining to listing expenses.
Since the total cost in connection with the listing and the share bonus program is of an unusual nature and nonrecurring, and significant in terms of the amount, these costs will be recognised as an item affecting comparability in this and future financial reports.
The Group's net financial items amounted to an expense of MSEK 0.2 (income: 0.2).
Following an assessment of the Parent Company's tax loss carryforwards, a tax revenue of MSEK 41.0 (0) was recognised. The Group's estimated tax for the year is a tax revenue of MSEK 44.7.
The result for the period was negative MSEK 159.5 (profit: 48.3).
| SEK thousand | 2015 | 2014 | 2013 | 2012 |
|---|---|---|---|---|
| Net revenue | 154,799 | 208,207 | 197,716 | 95,204 |
| Operating result before items affecting comparability | -30,464 | 62,319 | 127,316 | 18,761 |
| Operating result | -204,104 | 62,319 | 127,316 | 18,761 |
| Net financial items | -164 | 224 | -48 | -901 |
| Result for the period | -159,542 | 48,346 | 99,235 | 13,317 |
| Earnings per share before dilution, SEK | -6.33 | 2.06 | 17.01 | 2.28 |
| Earnings per share after dilution, SEK | -6.33 | 1.92 | 15.75 | 2.11 |
| Equity ratio in Group, % | 78% | 59% | 45% | 70% |
| Equity | 640,557 | 123,457 | 50,047 | 40,210 |
| Cash and cash equivalents | 716,096 | 56 | 5 | 3 |
| Number of employees at end of period | 48 | 43 | 36 | 31 |
| Number of employees in R&D at end of period | 35 | 28 | 29 | 25 |
* The consolidated accounts have been prepared in accordance with IFRS since 2012.
Total comprehensive income is the same as the result for the period, as the consolidated group contains no items that are recognised under other comprehensive income.
The cash flow comprises cash from operating activities, investment activities and financing activities. Net cash flow for the year totalled MSEK 716.1 (0.05), of which the cash flow from operating activities was negative MSEK 5.6, compared with positive MSEK 69.4 during 2014. The difference is mainly attributable to a licensing payment received through the signing of a licensing agreement with Braeburn Pharmaceuticals. Cash flow from investment activities generated a net inflow of MSEK 157.0, compared with a net outflow of MSEK 94.4 in the preceding year. The increased inflow is mainly attributable to the company's disconnection from the principal owner's Group-wide cash-pool account as of March 2015. In connection with the listing of Camurus' shares on 3 December 2015, the company raised MSEK 555 before issuance costs. Two more directed share issues were completed within the scope of the share bonus program and cash flow from financing activities during the year amounted to MSEK 564.7 (25,1).
At the start of 2015, cash and cash equivalents totalled MSEK 0.06 (0). Following the three share issues carried out within the framework of the "Invitation to acquire shares in Camurus AB," the company had cash and cash equivalents of MSEK 716.1 (0.06) on 31 December 2015.
At 31 December 2015, Group equity amounted MSEK 640.6 (123.5). The increase in equity compared with the year-earlier period was primarily attributable to the proceeds from the listing of the company's shares.
No loans had been raised as of 31 December 2015, and none have been raised since.
No assets were pledged at end of the period.
The company's sales patterns do not reflect any distinct seasonal variations.
The Group's operations are conducted in the Parent Company.
The Parent Company's revenue amounted to MSEK 154.8 (208.0) in 2015. Operating result before items affecting comparability was negative MSEK 28.7 (profit: 62.2). The operating result was a negative MSEK 202.4 (profit: 62.2).
The result for the year was negative MSEK 146.4 (profit: 34.2).
At 31 December 2015, the Parent Company's equity was MSEK 622.6 (92.3). The difference compared with the yearearlier period was mainly attributable to the capital raised in connection with the listing of the company's shares.
At the end of the period, total assets amounted to MSEK 801.2 (185.5), of which cash and cash equivalents MSEK 716.1 (0.06).
In preparation for the market approval of CAM2038 (weekly and monthly products), a process has been launched to develop an in-house commercial organisation to market the product, with an initial focus on prioritised European markets for opioid dependence. In December Richard Jameson was appointed to the position as Chief Commercial Officer with the responsibility for leading this key strategic venture. Mr. Jameson has broad experience from different senior commercial roles across a number of specialty pharmaceutical companies and markets. Most recently, he was responsible for leading a sales and marketing organisation in Europe, the Middle East and Africa, with a focus on the market for opioid dependence.
The Board of Directors was reinforced through the appointment of Kerstin Valinder Strinnholm and Marianne Dicander Alexandersson at the Extraordinary General Meeting held on 10 August 2015.
Camurus' operations are not subject to authorisation in accordance with the Swedish Environmental Code, but are regularly controlled through environmental inspections. The company abides by the requirements of government authorities on the management and destruction of hazardous waste and works proactively to reduce energy consumption and the use of environmentally hazardous substances. Camurus is not involved any environmental disputes.
Camurus' share capital amounted SEK 932,037 divided into 37,281,486 shares, with a quoa value per share of SEK 0.025. The total the number of shares outstanding at 31 December 2015 was 37,281,486 common shares, each of which carries one vote. At 31 December 2015, Sandberg Development AB was the single largest shareholder of Camurus, with a total of 20,014,978 shares, corresponding to 53.7 percent of the votes and capital.
In 2015, the average number of employees in the Group was 44 (38), of which 29 (24) were women. At year-end, the number of employees was 48 (43), of whom 35 (28) worked within research and development.
Of the total number of employees in 2015, 66 percent were women and 34 percent men. All employees receive the same treatment and are offered the same opportunities regardless of their age, gender, religion, sexual orientation, disabilities or ethnicity.
Salaries and other remuneration, including the sharebased bonus program that was completed in connection with the listing of the company's share on 3 December 2015, amounted to MSEK 179.6 (39.4).
Camurus is a Swedish public limited liability company with its registered office in Lund, Sweden. The company's share was listed on 3 December 2015 on Nasdaq OMX Stockholm and is traded under the ticker symbol, CAMX.
Camurus' corporate governance is based on the laws, regulations and recommendations applicable to listed companies, such as the Swedish Corporate Governance Code (the "Code"), the Nasdaq Stockholm Rule Book for Issuers, Camurus' Articles of Association and other rules and guidelines specific to the company. Camurus applies the Code.
This report pertains to the 2015 financial year and is a part of Camurus' directors' report, and has been reviewed by the company's auditors.
The aim of Camurus' corporate governance is to create a distinct allocation of roles and responsibilities between shareholders, the Board of Directors and the company's management.
The governance, management and control of Camurus is distributed between the general meeting of shareholders, Board of Directors and its elected Committees, and the CEO.
Camurus AB's share capital comprises one class of shares that entitles the holders to equal voting rights and equal rights to the company's assets. For information about shareholders and the Camurus share, see pages 28–29 or visit www.camurus.com.
Shareholders' exercise their influence at the general meeting, which is Camurus' highest decision-making body. The general meeting decide on the Articles of Association and at the Annual General Meeting (AGM), which is the scheduled annual general meeting of shareholders, shareholders elect the Board members, the Chairman of the Board and auditors, and resolve on their fees.
In addition, the AGM makes decisions on the adoption of the income statement and balance sheet, on the appropriation of the company's profits and on the discharge of Board members and the CEO from liability to
the company. The AGM also makes decisions on the composition and work of the Nomination Committee, and on remuneration guidlines and terms of employment for the CEO and other senior executives.
Shareholders are entitled to participate in the general meetings and to vote for their own shares. Shareholders are also entitled to be represented by proxy at the meeting. The AGM is to be held in Lund each year before the end of June. Extraordinary general meetings (EGMs) are convened as needed.
Notice convening the annual general meetings and extraordinary general meetings where amendments to the articles of association are to be addressed, must be done no earlier than six weeks and no later than four weeks prior to the meeting. Notice convening other extraordinary general meetings must be done no earlier than six weeks and no later than three weeks prior to the meeting. Official notice must be given
through an announcement in the Swedish Official Gazette (Sw. Post- och Inrikes Tidningar) and on the company's website. Simultaneously therewith, the fact that notice has been given must be published in Svenska Dagbladet.
At the AGM held on 11 May 2015, Per Olof Wallström was elected Chairman of the Board and Per-Anders Abrahamsson, Martin Jonsson, Per Sandberg, Björn Olsson, Svein Mathisen and Fredrik Tiberg were re-elected Board members.
The AGM resolved that:
Fees to the Chairman of the Board and Board members elected by the AGM, the election of the company auditors: Mazars SET Revisionsbyrå AB with Gunilla Malmsten as Auditor in Charge, and PricewaterhouseCoopers AB, with Ola Bjärehäll as Auditor in Charge.
At the EGM held on 10 August 2015, it was resolved that:
Election of Marianne Dicander Alexandersson and Kerstin Valinder Strinnholm as Board members, new fees to the Chairman of the Board and Board members, as well as fees for committee work.
At the EGM held on7 October 2015, resolutions were passed on the following changes to:
the Articles of Association, the company's category being changed from private to public, the Board's registered office and the limits on share capital and the number of shares, the method of convening a meeting as well as the introduction of CSC provision and the classification of shares.
At the EGM held on 18 November 2015, resolutions were passed with regard to: A invitation to subscribe for shares in the company to the general public in Sweden and to institutional investors, as well as a direct issue to employees and Board members within the framework of fulfilling the company's share-bonus program, and a direct issue of shares to Sandberg Development AB in accordance with the agreement signed with the company to assume the costs of social-security contributions that arise, net after tax, from this share-bonus program.
Camurus' 2016 AGM will be held on Tuesday, 3 May 2016 at 5:00p.m. at Elite Hotel Ideon, on Scheelevägen 27, Ideon Science Park, 223 63 Lund, Sweden. For further information and the right to participate, see page 81.
The minutes of the AGM and EGMs will be available at: www.camurus.com.
The Nomination Committee of Camurus is tasked with assignments including the preparation and drafting of proposals for the election of Board members, the Chairman of the Board, the Chairman of the Meeting and auditors. The Nomination Committee's duties also include the proposal of fees to Board members, committee members and auditors.
The EGM on 7 October 2015 reslolved on the following instructions to Camurus' Nomination Committee, which apply until further notice. The Nomination Committee for the next AGMs is to comprise representatives of the three largest shareholders, in terms of votes, as registered at 30 September each year in the share register maintained by Euroclear Sweden AB . In view of the listing of the company's share on 3 December 2015, the Nomination Committee for the 2016 AGM is to comprise representatives of the three largest shareholders at 31 December 2015 in terms of votes, and the Chairman of the Board, who will also convene the
Nomination Committee for its first session. Unless unanimously resolved otherwise by the Nomination Committee, the Board member representing the largest shareholder in terms of votes is to be appointed Chairman of the Nomination Committee.
If, earlier than two months prior to the annual general meeting, one or more of the shareholders having appointed representatives to the Nomination Committee no longer are among the three largest shareholders in terms of voting rights, representatives appointed by these shareholders shall resign, and the shareholder or shareholders who has then become one of the three largest shareholders in terms of voting rights may appoint one representative each. Should a member resign from the Nomination Committee before its work is completed and the Nomination Committee considers it necessary to replace him or her, such substitute member is to represent the same shareholder or, if the shareholder is no longer one of the largest shareholders in terms of voting rights, the largest shareholder in turn. Changes in the composition of the Nomination Committee shall be made public immediately.
The composition of the Nomination Committee prior to each AGM is to be publicly announced not later than six months prior to the AGM, but due to the listing of the company's share on 3 December, the composition of the Nomination Committee prior to the 2016 AGM is to be announced publicly as soon as possible after the members have been appointed. No fees are to be paid to members of the Nomination Committee. The company is to bear any necessary expenses for work performed by the Nomination Committee. The Nomination Committee's term of office extends until such time that the composition of the next Nomination Committee is publicly announced. The Nomination Committee's duties include submitting proposals for amendments of the instruction to the Nomination Committee to the extent deemed necessary.
The Nomination Committee comprises the three largest shareholders as registered with Euroclear Sweden AB at 31 December 2015, see above, and collectively represents about 65 procent of the number of shares and votes in the company. The Nomination Committee held two meetings in 2016.
| Representatives | Shareholders |
|---|---|
| Per Sandberg | Sandberg Development AB |
| Jan Andersson | Swedbank Robur Fonder |
| Mikael Hanell | Catella Fondförvaltning AB |
Per Olof Wallström Styrelseordförande i Camurus AB 1) The shareholder statistics used must be sorted according to voting power (shareholder groups) and comprise the 25 largest shareholders. In the event that these shareholder statistics comprises nominee-registered holdings, such holdings will only be taken into consideration if the administrator has declared the underlying shareholder's identity to Euroclear Sweden, or if the company – without implementing any own measures – obtains other information to indicate the underlying shareholder's identity.
2) Fredrik Tiberg, the third-largest shareholder, has abstained from participation in the Nomination Committee and is to be replaced by the next largest shareholder
The work of the Board of Directors during the year was dominated by issues pertaining to decisions and preparations for the listing of the company's share on Nasdaq Stockholm. This included the adoption of updated company strategies, such as the establishment of an in-house commercial organisation for CAM2038 in selected key European markets, resolutions on financial targets and dividend policy, the change in the existing cash-bonus program for employees and the Board of Directors to a share-based bonus program, as well as decisions pertaining to the terms and conditions for the issue of new shares in Camurus.
In accordance with the Articles of Association, Camurus' Board of Directors is to comprise a minimum of three and maximum of ten Board members elected by the AGM, for the period until the end of the next AGM. At the 2015 AGM, seven Board members were elected and at the EGM held on 10 August 2015, another two Board members were appointed. Camurus' CEO is included among the Board of Directors and the company's CFO functions as the Secretary to the Board. Other executives of Camurus participate at Board meetings to report on specific topics. According to the Code, a majority of the AGM-elected Board members must be independent in relation to the company and the company's management.
With the exception of CEO Fredrik Tiberg, all Board members are deemed to be independent in relation to the company and the company's management. Five of these Board members are also deemed to be independent in relation to the company's major shareholders. Camurus' thus meets the requirements of the Code on independence.
At the close of the financial year, Camurus' Board of Directors comprised nine Board members: Chairman of the Board Per Olof Wallström and the Board members, Per-Anders Abrahamsson, Marianne Dicander Alexandersson, Martin Jonsson, Svein Mathisen, Björn Olsson, Per Sandberg, Fredrik Tiberg and Kerstin Valinder Strinnholm. Information about the Board members, with data about birth years, year of election to the Board of Directors, experience, ongoing and previous assignments, holdings of shares in other companies exceeding five percent and holdings in the company at 29 January 2016 are presented on pages 76–77. Holdings in the company include the individual's personal holdings and/or the holdings of closely related parties. Other Group assignments are not presented.
The duties of the Board of Directors are regulated under the Swedish Companies Act and the Articles of Association, and, following the listing on Nasdaq Stockholm, the Swedish Corporate Governance Code. The work of the Board of Directors is further regulated by the written Rules of Procedure, which is adopted each year by the Board. The Rules of Procedure regulate the division of duties and responsibilities between the Board, the Chairman of the Board and the CEO. In addition, the Rules of Procedure govern the
resolutions procedure within the Board, the Board's meeting plans and the work of the Board on financial reporting and auditing issues, as well as the financial statements. The Board has also established instructions for the CEO and adopted other separate policy documents.
The Board is responsible for the Group's organisation and the management of its affairs, the establishment of the Group's overall objectives, development and follow-up activities pertaining to the overall strategies, resolutions regarding major acquisitions, divestments and capital expenditures, resolutions regarding possible investments and loans in accordance with financial policy, continuous monitoring of operations, the adoption of quarterly and year-end accounts, and the continuous assessment of the CEO and other members of Group management. The Board is also responsible for ensuring quality in financial reporting, including systems for the monitoring and internal control of Camurus' financial statements and financial position (see also "Internal controls" below). Furthermore, the Board is to ensure that Camurus' external disclosure is characterised by transparency and is correct, relevant and reliable. The Board is also responsible for the establishment of the requisite guidelines and other policy documents, such as a Communication Policy and Insider Policy. At Board meetings, the following recurring items are on the agenda: state of business, project status, market issues, adoption of interim reports, strategic review, future prospects and economic and financial reporting.
The Chairman of the Board monitors Camurus' operations through continuous contact with the CEO. The Chairman organises and directs the work of the Board and is responsible for ensuring that other Board members receive satisfactory information and decision data. The Chairman is also responsible for ensuring that both existing and new Board members continuously update and deepen their knowledge of Camurus and that they otherwise receive further training required for the work of the board to operate effectively. It is also the Chairman who is responsible for managing contacts with shareholders on ownership issues and for the annual evaluation of work of the Board of Directors. In 2015, an anonymous survey-based evaluation was performed, through which all the Board members received the opportunity to express themselves about the work of the Board of the company. This information has been collected, compiled and presented by the company's solicitors. The Nomination Committee, through its Chairman, has reviewed the evaluation of the Board and received information about the company's development. The principal requirements that should be imposed on Camurus' Board of Directors and the importance of independent Board members have been discussed.
In addition to the inaugurating Board meeting, a minimum of five ordinary Board meetings are to be held. The Board meets with auditors at the Board meeting when the audit is reviewed.
During the year, the Board held 11 meetings, of which five were scheduled and six were extraordinary meetings. Three of the six extraordinary meetings pertained to decisions made per capsulam. The Board has mainly
addressed and taken strategic decisions on matters pertaining to the listing of the company's share. The Board has planned a total of six meetings for 2016.
Within itself, the Board of Directors has established two committees, an Audit Committee and a remuneration Committee, which operates according to rules of procedure adopted by the Board of Directors.
The main duties of the Audit Committee are to supervise the Company's financial reporting, monitor efficiency in its internal controls, internal audit and risk management, and apprise itself of information regarding the audit of the annual report and consolidated financial statements, review and monitor the auditor's impartiality and independence and, in so doing, 1 Björn Olsson was the Chairman of the Board up to and including 20 April 2015. Take particularly into account whether the auditor provides Camurus with services other than audit services. The Audit Committee shall also assist the Nomination Committee with proposal to the general meeting for election of auditors. The Audit Committee has regular contacts with the auditors of Camurus. The members of the Audit Committee are Martin Jonsson (Chairman), Per Olof Wallström, Svein Mathisen and Björn Olsson. The committee complies with the Companies Act's requirements for independence and accounting and auditing expertise. The Committee has convened four times during the year and one meeting concerning risk management was conducted together with the Group management. Camurus' auditors were present at three of these meetings. The meetings addressed items such as the audit plan, the auditors' observations and the review of the company and the company's quarterly reports. Information regarding fees to auditors is provided in Note 8.
The main duties of the Remuneration Committee are to prepare decisions by the Board of Directors on issues concerning remuneration principles, remuneration and other employment terms for the CEO and other members of the Group management, and to monitor and assess ongoing programs for variable remuneration to the Group management, as well as such programs as have been completed during the year. Furthermore, the Committee shall monitor and assess the application of the guidelines for remuneration to the executive management resolved by the annual general meeting, as well as applicable remuneration structures and remuneration levels in the Company. The members of the Remuneration Committee are Per Olof Wallström (Chairman), Martin Jonsson and Svein Mathisen. The Committee is assessed to comply with the Code's requirements for independence and appropriate knowledge and experience in questions related to remuneration of executive management.
The Committee convened four times during the year. At these meetings, the Committee discussed the company's existing remuneration systems, proposed guidelines for the remuneration of the CEO and senior executives, and the focus of future share-based incentive programs aimed at attracting and retaining competent and motivated employees. The incentive
programme will be presented at the AGM in May 2016, for resolution by the shareholders.
Information regarding salaries and fees to the CEO and senior executives is provided in Note 9.
The CEO is responsible for the ongoing administration and development of Camurus in accordance with applicable legislation and rules, including the Nasdaq Stockholm Rule Book for Issuers and the Code, as well as the guidelines, instructions and strategies established by the Board of Directors. The CEO is to ensure that the Board of Directors receives the requisite factual and relevant information to enable taking well-founded decisions. Furthermore, the CEO is to ensure adherence to Camurus' goals, policies and strategic plans as established by the Board of Directors and the CEO is responsible for keeping the Board updated on Camurus' development in-between Board meetings.
The CEO directs the work of the Group management, which is responsible for overall business development. In addition to the CEO, Camurus' Group management comprises the CFO, the Vice President for Project Management and Planning, the Vice President for Pharmaceutical and Analytical Development, the Vice President for Technical Operations, the Vice President for Clinical and Regulatory Development, Vice President for Business Development and Alliance Management, and the Vice President for Investor Relations (a total of eight individuals). For information about current senior executives at Camurus, when they assumed their positions and their year of birth, education, experience, holdings in the Company and
current and previous assignments, see pages 78–79. Their holdings in the Company at 29 January 2016 are also presented. Holdings in the Company include the individual's personal holdings and/or the holdings of closely related parties. Other Group assignments are not presented.
The AGM of 11 May 2015 resolved that for the period up to the closing of the 2016 AGM, fees totalling SEK 350,000 are to be paid, divided between the Board members as follows: SEK 170,000 to the Chairman of the Board and SEK 60,000 to each of the other Board members who is not an employee of the company or dependent in relation to the company's largest shareholder. No fees beyond the standard directors' fees are to be paid for committee work. At the EGM on 10 August 2015, it was resolved that from this day, a fee of SEK 300,000 be paid to the Chairman of the Board and SEK 150,000 to each and every other non-executive director, considering the planned listing of Camurus on Nasdaq Stockholm. Fees to Per Sandberg and Martin Jonsson are to be paid proportionally as of 1 January 2016. The EGM further resolved that for committee work, a fee of SEK 50,000 be paid, according to the same principle above, to the Chairman of the Audit Committee and SEK 25,000 to each other member of the Committee, while no fees be paid for work in the Remuneration Committee.
Fees to Board members elected by the AGM are decided by the AGM in accordance with proposals from Nomination Committee.
| Resolved fees and benefits 2015 | Remuneration, SEK thousand | Attendance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Board member | Function | Independence | Directors' fee8) |
Audit Committee8) |
Remuneration Committee8) |
Sharebased program ended 20156) |
Total | Board of Directors |
Audit Committee |
Remuneration Committee |
| Björn Olsson3) | Board member | 2 | 128 | 25 | – | 3,005 | 3,152 | 11/11 | 3/4 | – |
| Per-Anders Abrahamsson | Board member | ● | 128 | – | – | 3,005 | 3,133 | 9/11 | – | – |
| Marianne Dicander Alexandersson4,5) Board member | ● | 112 | – | – | 601 | 713 | 6/11 | – | – | |
| Martin Jonsson | Board member | 2 | 56 | 25 | – | 3,005 | 3,080 | 11/11 | 4/4 | 4/4 |
| Svein Mathisen5) | Board member | ● | 128 | 25 | – | 3,005 | 3,152 | 11/11 | 4/4 | 4/4 |
| Per Sandberg | Board member | 2 | 56 | – | – | – | 56 | 11/11 | – | – |
| Fredrik Tiberg7) | Board member, President and CEO |
1 | – | – | – | – | – | 11/11 | – | – |
| Kerstin Valinder Strinnholm4) | Board member | ● | 112 | – | – | 601 | 713 | 6/11 | – | – |
| Per Olof Wallström5) | Chairman of the Board | ● | 268 | 25 | – | 3,005 | 3,292 | 11/11 | 4/4 | 4/4 |
| Totalt | 988 | 100 | 0 | 16,227 | 17,291 |
1) The Board member is to be regarded as dependent in relation to the company and its Management.
2) The Board member is to be regarded as dependent in relation to major shareholders.
3) The company's Chairman of the Board up to and including 25 mars 2015.
6) Refers to share-related bonus program, refer also to Note 28.
5) The fee refers to directors' fees excluding social security contributions paid to the Board member's company.
4) Elected at the EGM held on 10 August 2015.
7) For remuneration to the CEO, refer to Note 28. 8) AGM resolved fees, proportionally accounted, for the period May 2015–May 2016.
The table below shows the fees paid to the elected Board members in 2015.
Guidelines for remuneration and other employment terms for senior executives, 2015
The EGM of 7 October 2015 resolved to approve the Board of Directors' proposal on the principles of remuneration to the company's senior executives as follows, until the time of the 2016 AGM. In this context, the term senior executives refers to Camurus' CEO and the managers reporting to the CEO at any time, who are part of the company's management team.
The company is to offer a market-aligned terms that facilitate the recruitment and retention of qualified senior executives. Remuneration comprises a balanced composition of fixed salary, variable remuneration, pension benefits, other benefits as well as conditions for termination. Cash remuneration comprises fixed salary and, when applicable, variable remuneration. The fixed salary and variable
remuneration should be proportionate to the executive's responsibilities and authorities.
Long-term incentive programs may be offered as a complement to the above, but must be referred to the general meeting for adoption. Remuneration is primarily based on the individual's position and performance, and the company's and the individual's fulfilment of pre-defined targets.
The fixed salary of the CEO and other senior executives should be monthly, at market rates, and reflect the requirements and responsibilities that their positions entail.
Variable remuneration is based on outcomes in relation to pre-determined, well-defined targets. These targets are set with the aim of promoting the company's/Group's development, and to generate value and financial growth in the long term. Variable remuneration payments are to be maximised and may not exceed 30 percent of the fixed annual salary. Variable remuneration may also be paid in the form of long-term incentive programs.
Long-term incentive programs are to be available as a complement to fixed salaries and
variable remuneration. Decisions on sharebased programs are made by the general meeting. Programs for variable remuneration should be designed to allow the Board of Directors, if exceptional financial conditions prevail, to restrict or omit payment of the variable remuneration if such action is deemed reasonable and consistent with the company's responsibility towards shareholders, employees and other stakeholders.
The company has had a long-term cashsettled incentive program in place since 2013, aimed at employees and Board members at Camurus, in which the right to receive a bonus in relation to bonus shares issued entered force in conjunction with a public listing of Camurus' shares. On 12 June 2015, the cash-regulated program was amended to the extent that Camurus' participants on the day of listing would receive a share bonus, referred to below as the share-bonus program, in the form of Camurus shares. The shares were to be received in exchange for payment of the share's quota value, i.e. essentially free of charge. Should an exit event have occurred involving the transfer of more than 90 percent of all shares in Camurus, employees and Board members would have been entitled to receive cash.
The Camurus share was listed on 3 December 2015. Accordingly, the terms of the share bonus program had been met and the employees and Board members who were employed at that point in time were entitled to an allocation of shares in accordance with the bonus agreement.
The fair value of the bonus program was based on the enterprise value when Camurus' shares were listed on the stock exchange. The
share price on the redemption date for the share bonus program was SEK 57. The total number of allocated shares was 1,909,483 shares. The total cost for the bonus programme, which was charged to earnings in 2015, was SEK 108.9 million after tax, with a corresponding increase in equity of SEK 108.8 million and a social security liability of SEK 30.8 million.
The terms of the share bonus program have now been met in full and no additional costs will be charged against Camurus' earnings under this program.
Pension benefits are payable in accordance with applicable ITP plans or otherwise be premium-based and amount to a maximum of 35 percent of the salary. Benefits other than fixed salary, variable remuneration and pension benefits are to be applied with restriction.
A termination notice of 12 months from the company and 6 months from the CEO applies between the company and its CEO. In the event that the CEO's employment in the company is terminated due to, or in connection with, the transfer of the company to new owners, a 24-month notice of termination from the company applies. During the period of notice, fixed monthly salaries and other forms of remuneration are to be paid in accordance with the applicable employment contracts. In such an event, remuneration from the company is not to be reduced by other forms of compensation that the CEO may receive during the period of notice. If notice of termination is issued by the CEO, no severance payments will be made.
A mutual notice period of 3 to 6 months applies to termination of contract between the company and other senior executives.
To the extent that Board members perform work for the company, in addition to work on the Board of Directors, a marketaligned consultancy fee may be payable for such work. Remuneration is to be in line with market terms and the amount, as with other terms, is decided by the Board of Directors.
The Board is entitled to deviate from these guidelines if the Board warrants that there are particular grounds for doing so in individual cases.
For one of the senior executives, in order to attract staff with key skills, deviations against the above guidelines have been made during the year. These deviations means that the agreed conditions provide the opportunity to receive variable compensation of a maximum of 45 percent of the fixed basic salary, and that a compensation of MSEK 2.2 was paid in connection with the signing of the employment contract with the senior executive. This amount, net after withheld tax, have been used in full to subscribe for shares in Camurus. Also as deviation from the guidelines established at the EGM in October 2015, the Board has, in order to provide the CEO with market-based conditions, resolved to allow variable cash remuneration of a maximum of 40 percent. The resolution shall enter into force 1 January, 2016. Without constituting a deviation, it is hereby also informed of that the variable remuneration, for the year of 2015, to the CEO was resolved before the adoption of the new guidelines at the EGM, 7 October, 2015. Thus the results of
the variable remuneration in 2015 of about 38 percent of the annual fixed salary, exceeded the later adopted guidelines with a ceiling on variable remuneration of 30 percent. The variable remuneration is based on the outcome of the activities previously agreed and approved by the Board objectives. Other benefits to the CEO and other senior executives are part of the total compensation. With pension costs means costs of pension payable under the agreement
Camurus had no outstanding share-based program at the close of 2015.
In essence it is proposed that the guidelines in its design is unchanged against the decision by the Extraordinary General Meeting on 7 October 2015. The guidelines for 2015 are provided on pages 42–43.
Regarding the variable cash remuneration for the CEO an adjustment is proposed to limit the amount to a maximum of 40 procent of the basic salary.
The Board of Directors' responsibility for internal controls are regulated by the Companies Act, the Annual Accounts Act – which includes requirements that the Corporate Governance Report must contain disclosures concerning the principal features of Camurus' internal-control and risk-management systems in connection with the annual financial reporting and the preparation of the consolidated financial statements – and
the Code. The Board of Directors is to ensure that Camurus has appropriate internal controls and formalised procedures to ensure its compliance with established policies for financial reporting and internal controls, and the existence of appropriate systems for the monitoring and control of the company's activities and the risks associated with the company and its operations.
Camurus applies COSO's framework for the internal control of financial reporting. The procedures for internal controls on financial reporting were designed with the aim of ensuring reliable overall financial reporting and external reporting in accordance with IFRS, applicable laws and regulations, and other requirements applicable to companies listed on Nasdaq Stockholm. This work involves the Board of Directors, Group management and other employees.
The Board of Directors has established instructions and governing documents with the aim of regulating the CEO's and the Board of Directors' roles and division of responsibilities. The manner in which the Board of Directors monitors and assures the quality of internal controls is documented in the Board of Directors' rules of procedure and Camurus' financial policy, as well as the policy for internal control, where the Board of Directors has established a number of fundamental guidelines of significance to the work with internal control. These guidelines include the regular control and follow-up of outcomes in comparison with expectations and preceding years, as well as supervision of the accounting policies applied by Camurus. The responsibility for maintaining an effective
control environment and the ongoing work on risk assessment and internal control over the financial reporting is delegated to the CEO. However, the Board of Directors has ultimate responsibility. In turn, managers at various levels at Camurus have corresponding responsibilities within their respective spheres of responsibility.
Group management reports regularly to the Board of Directors in accordance with established procedures. The financial reporting control environment collectively comprises various responsibilities and authorities, instructions, guidelines, manuals and policies, in combination with laws and regulations.
Based on an efficient control environment and external reviews by auditors, the Board of Directors has deemed that there are no special circumstances in Camurus' operations or other circumstances to warrant the establishment of an internal-audit function.
Camurus performs continuous risk assessment to identify risks pertaining to financial reporting, as well as risks associated with the company's operations. These risks include inaccurate reporting as well as impropriety and fraud. Risk management is incorporated in each process and various methods are used to evaluate, identify and curtail risks, and to ensure that the risks to which Camurus is exposed are managed in line with the set policies, instructions and monitoring procedures.
The formulation of control activities is of particular importance to Camurus' work to prevent and identify risks and shortcomings in the financial reporting. The control structure comprises distinct roles in the organisation that facilitate an efficient division of responsibilities for specific control activities, including authorisation control, IT systems and attestation control. The continuous analyses carried out of the financial reporting are crucial to ensuring that the financial reports do not include any material errors.
Camurus has information and communication procedures aimed at promoting completeness and accuracy in financial reporting. Policies, guidelines and internal instructions with regard to financial reporting are available in digital and printed form. Regular updates on amendments to accounting policies, reporting requirements or other forms of information disclosure are accessible and known to the employees concerned. For external disclosure of information, guidelines have been designed with the aim of ensuring that Camurus meets the requirements covering the disclosure of accurate information to the market.
The Board of Directors continuously evaluates the information submitted by Group management. The Board of Directors obtains regularly updated financial information about Camurus' development between Board meetings. The Group's financial position, strategies and capital expenditures are discussed at each Board meeting. The Board of Directors is also responsible for monitoring internal controls. This work entails ensuring that measures are taken to manage any shortcomings, as well as following-up on any proposed measures highlighted in connection with external reviews. The company performs an annual self-assessment of its work with risk management and internal controls. This process includes a review of the manner in which established procedures and guidelines are applied. The Board of Directors receives information about important conclusions from this annual assessment process, and about proposed actions, if any, with regard to the company's internal control environment. In addition, the external auditors report on a regular basis to the Board of Directors, partly through the Audit Committee and partly to the Board of Directors in its entirety.
The AGM appoints external auditors for a period of one year at a time. The auditors review the annual accounts and bookkeeping, as well as the Board of Directors' and CEO's administration in accordance with an audit plan established in consultation with the Board's Audit Committee. In connection with the review, the auditors report their findings to Group Management for discussion and subsequently to the Board of Directors through the Audit Committee. Reporting to the Audit Committee is carried out in conjunction with the completion of the examination of the administration and the review of the hard close of the annual accounts. The Board of Directors meets with the auditors not less than once a year, when the auditors report their observations directly to the Board of Directors without the presence of Camurus' CEO and CFO. The auditor's also participate at the AGM, where they present a summary of their auditing work and their recommendations in the audit report.
Camurus and its operations are associated with risks, based on the targets it has set. Camurus' integrated process for risk management is aimed at ensuring that risks and uncertainties are identified, assessed and managed at the earliest stage possible.
At Camurus, risk management is an integrated part of day-to-day operations and the management team continuously takes an inventory of the risks and performs risk assessments based on the company's set goals. Risk assessment evaluates the probability of a risk occurring and the consequences of such a risk materialising into an event. Identified risks and risk-minimisation measures are documented. Feedback is provided to the Board of Directors on a continuous basis.
Tax and financial risks are subject to regular review for preventative purposes and any tax, legal or financial risk deemed substantial is reported in the consolidated financial statements.
Camurus currently has, either itself or together with partners, six projects based on five products that are in the clinical-development phase and a number of projects undergoing pre-clinical trials. The projects require continued research and development, which are subject to standard risks that product development becomes delayed and that costs become higher than expected or that the products prove to be insufficiently effective or safe at any stage of their development.
There is a risk that products based on the company's injection depot or its technology platforms are delayed to market or never reach it, and that problems that make it more difficult to produce, or enter into partnerships for, additional products with future commercial value, are identified.
Prior to launching a product candidate in the market, Camurus or its partner must carry out pre-clinical and clinical trials to document and prove that the product gives rise to significant efficacy and has an acceptable safety profile. Camurus is unable to predict with any certainty when planned clinical trials can be started or when ongoing trials can be completed since these are circumstances that are affected by numerous different factors outside Camurus' direct control, for example, regulatory approval, ethical review, access to patients and clinical trial units, performing the clinical trial at the trial unit and the considerations of Camurus' partners. It is also difficult to accurately predict the costs associated with clinical trials. Actual
costs for carrying out a trial may significantly exceed estimated and budgeted costs. Clinical trials may also give rise to results that do not confirm the intended treatment efficacy or an acceptable safety profile due to undesirable side effects or an unfavourable risk-benefit assessment of the product. This could lead to clinical trials being discontinued or cancelled, or the product not being granted the necessary regulatory approval for further clinical trials or sale in the market.
Camurus is dependent on the continued success of these products and on negative results not arising or negative decisions not being made on the continuation of product development.
Camurus' strategy to build a balanced project and product portfolio includes the signing of partnership agreements with other pharmaceutical and biotech companies regarding, for example, joint development and/or approval and market launch.
Obtaining licenses and approvals can be time-consuming and can further delay, hinder or make the development and commercialisation of a product more expensive, for example, due to differing opinions on which clinical trials are required for registration, even between the authorities of different countries, or manufacturing not being deemed to meet the applicable requirements. Authorities may make different assessments compared with Camurus and Camurus' partners, for instance, regarding the interpretation of data from trials or the quality of data. Changes in authorities' practices or procedures, as well as new or changed rules, may require additional work or ultimately result in the necessary license not being obtained or withdrawn.
If a pharmaceutical product obtains market approval, the risk remains that sales, regionally or globally, may not meet expectations and that the product is not commercially successful..
A risk exists that existing and future patents, brands and other intellectual property rights held by Camurus will not comprise full commercial protection from infringement and competition.
Camurus' competitors include international pharmaceutical companies, biotech companies and specialist pharmaceutical companies. Some competitors have substantial financial, technical and staffing resources as well as considerable manufacturing, distribution, sales and marketing capacities. There is also the risk of Camurus' products that are under development, being subject to competition from similar products or entirely new product concepts that provide greater added value to patients.
Camurus is exposed to currency risks in the form of transaction exposure. Camurus' registered office is located in Sweden and reports on its financial position and earnings in SEK. Transaction exposure occurs in the course of purchases and sales of goods and services in currencies other than SEK. A significant portion of Camurus' revenue and expenses are in foreign currencies and will continue to be so in the future. Camurus' financial policy allows for the use of hedging instruments. However, if Camurus' measures for managing the effects of exchange-rate fluctuations do not prove to be sufficient, Camurus' financial position and profits may be adversely impacted.
Credit risk is the risk that a counterparty is unable to fulfil its payment obligations, thereby resulting in a loss for Camurus. If Camurus' measures to manage credit risks are inadequate, this could have a negative impact on Camurus' financial position and earnings.
There are existing risks that the cash flow from operations remains neutral or negative until such time as Camurus can generate continuous annual revenue from products in the market. Going forward, Camurus will continue to require significant capital for continuing the research and development of potential products. Both the extent and timing of the Camurus' future capital requirements depend on a number of factors, such as costs for the operations, the potential success of research and development projects and opportunities for entering into partnership and licensing agreements, the timing for the receipt and amount of milestone payments and royalties, and the market reception of potential products. Access to and the terms and conditions for additional financing are influenced by several factors, such as market conditions, the general availability of credit and Camurus' credit rating and credit capacity. There is always the risk that Camurus cannot raise financing at acceptable terms.
When publishing the year-end report, the Board of Directors submitted the following outlook:
The company management makes estimates and assumptions about the future. Such estimates can deviate considerably from the actual outcome, since they are based on various assumptions and experiences. The estimates and assumptions that may lead to the risk of significant adjustments to reported amounts for assets and liabilities relate mainly to measurement and allocation of revenue and costs in connection with licensing agreements.
Risks in ongoing development projects comprise technical and manufacturingrelated risks (including products failing to meet set specifications post manufacturing), safety and effect-related risks that can arise in clinical trials, regulatory risks relating to applications for approval of clinical trials and market approval, commercial risks relating to the sale of proprietary and competing products and their development in the market, as well as IP risks relating to approval of patent applications and patent protection. In addition, there are risks relating to the development, strategy and management decisions of Camurus' partners.
Camurus pursues operations and its business in the international market and the company is therefore exposed to currency risks, since revenue and costs arise in different currencies, mainly SEK, EUR and USD.
The Board of Directors has not changed its outlook on future developments in relation to their outlook published in the yearend report for 2015.
On January 4, 2016, a licensing agreement was signed with Rhythm Pharmaceuticals regarding the CAM4072 product for the treatment of genetic obesity. The agreement had no impact on revenue and earnings in 2015.
On February 4, 2016, the appointment of the Nomination Committee in respect of the 2016 Annual General Meeting was published. For further information, visit www.camurus.com
Proposed appropriation of profits for the financial year:
The following is at the disposal of the AGM: The Board of Directors proposes that the retained earnings of SEK 610,310,448 be carried forward.
The Board of Directors proposes that no dividend is paid for the 2015 financial year. For further information on the company's earnings and financial position, refer to the following income statement and balance sheet with accompanying notes to the accounts.
| Financial year | ||||
|---|---|---|---|---|
| KSEK | Note | 2015 | 2014 | |
| Net sales | 5 | 154,799 | 208,207 | |
| Cost of goods sold | 6 | -237 | -656 | |
| Gross profit | 154,562 | 207,551 | ||
| Operating expenses | ||||
| Marketing and distribution costs | 6, 29 | -19,411 | -11,402 | |
| Administrative expenses | 6, 8, 29 | -11,934 | -22,165 | |
| Research and development costs | 6, 29 | -153,080 | -114,146 | |
| Other operating income | 7, 13 | 57 | 2,481 | |
| Other operating expenses | 13 | -658 | – | |
| Operating result before items affecting comparability |
29 | -30,464 | 62,319 | |
| Items affecting comparability attributable | ||||
| to public listing costs | 29 | -33,970 | – | |
| Items affecting comparability attributable to Share bonus program |
24, 29 | -139,671 | – | |
| Operating result | 9, 26, 28 | -204,104 | 62,319 | |
| Result from financial items | ||||
| Finance income | 10 | 2 | 394 | |
| Finance expenses | 10 | -166 | -170 | |
| Net financial items | -164 | 224 | ||
| Result before tax | -204,268 | 62,543 | ||
| Income tax | 11 | 44,727 | -14,197 | |
| Result for the period | -159,542 | 48,346 |
Total comprehensive income is the same as result for the period, as the consolidated group contains no items that are recognized under other comprehensive income.
Earnings per share based on earnings attributable to parent company shareholders for the period (in SEK per share)
| Not | 2015 | 2014 | |
|---|---|---|---|
| Earnings per share before dilution, SEK | 12 | -6.33 | 2.06 |
| Earnings per share after dilution, SEK | 12 | -6.33 | 1.92 |
Total comprehensive income is attributable to parent company shareholders. 46 Camurus annual report 2015 47
| Financial year | ||||
|---|---|---|---|---|
| KSEK | Note | 2015 | 2014 | |
| Net sales | 5 | 154,799 | 207,982 | |
| Cost of goods sold | 6 | -237 | -525 | |
| Gross profit | 154,562 | 207,457 | ||
| Operating expenses | ||||
| Marketing and distribution costs | 6 | -19,411 | -11,402 | |
| Administrative expenses | 6, 8 | -11,934 | -22,087 | |
| Research and development costs | 6 | -151,354 | -114,250 | |
| Other operating income | 7, 13 | 57 | 2,481 | |
| Other operating expenses | 13 | -658 | – | |
| Operating result before items affecting comparability |
-28,738 | 62,199 | ||
| Items affecting comparability attributable to public listing costs |
29 | -33,970 | – | |
| Items affecting comparability attributable to Share bonus program |
24,29 | -139,671 | – | |
| Operating result | 9, 26 | -202,379 | 62,199 | |
| Result from interests in Group companies | 17 | – | -1,697 | |
| Interest income and similar items | 10 | 2 | 394 | |
| Interest expense and similar items | 10 | -166 | -140 | |
| Result after financial items | -202,543 | 60,756 | ||
| Appropriations | ||||
| Change in accelerated depreciation | -414 | -838 | ||
| Change in untaxed reserves | 15,510 | -15,510 | ||
| Profit/loss before tax | -187,447 | -44,408 | ||
| Tax on profit for the period | 11 | 41,026 | -10,198 | |
| Result for the period | -146,421 | 34,210 |
Total comprehensive income is the same as profit/loss for the period, as the parent company contains no items that are recognized under other comprehensive income.
The notes on pages 52 for 73 is an integral part of the annual and consolidated accounts.
| KSEK | Note | 31-12-2015 | 31-12-2014 |
|---|---|---|---|
| ASSETS | 2 | ||
| Fixed assets | |||
| Intangible assets | |||
| Capitalized development expenditure | 14 | 20,823 | 22,551 |
| Tangible assets | |||
| Equipment | 15 | 6,634 | 7,119 |
| Financial assets | |||
| Long-term receivables Group companies | – | 406 | |
| Deferred tax receivables | 16 | 39,317 | – |
| Total fixed assets | 66,775 | 30,076 | |
| Current assets | |||
| Inventories | |||
| Finished goods and goods for resale | 3,241 | 702 | |
| Current receivables | |||
| Receivables from Group companies | 18, 19 | 207 | 157,908 |
| Trade receivables | 18, 20 | 8,917 | 6,118 |
| Other receivables | 5,500 | 1,883 | |
| Prepayments and accrued income | 21 | 15,613 | 10,925 |
| Cash and cash equivalents | 18, 22 | 716,096 | 56 |
| Total current assets | 749,574 | 177,592 | |
| TOTAL ASSETS | 816,349 | 207,668 |
| KSEK | Note | 31-12-2015 | 31-12-2014 |
|---|---|---|---|
| EQUITY | 2, 23 | ||
| Equity attributable to parent company shareholders |
|||
| Share capital | 932 | 630 | |
| Other contributed capital | 626,181 | 58,634 | |
| Retained earnings, including result for the period | 13,444 | 64,193 | |
| Total equity | 640,557 | 123,457 | |
| LIABILITIES | 2 | ||
| Long-term liabilities | |||
| Deferred tax liability | 16 | – | 8,537 |
| Total long-term liabilities | 8,537 | ||
| Short-term liabilities | |||
| Liabilities to Group companies | 18 | – | 1,697 |
| Trade payables | 18 | 31,832 | 9,938 |
| Income taxes | 9,917 | 9,600 | |
| Other liabilities | 18 | 88,088 | 1,287 |
| Accrued expenses and deferred income | 25 | 45,954 | 53,152 |
| Total short-term liabilities | 175,791 | 75,674 | |
| TOTAL EQUITY AND LIABILITIES | 816,349 | 207,668 |
| KSEK | Note | 31-12-2015 | 31-12-2014 |
|---|---|---|---|
| ASSETS | 2 | ||
| Fixed assets | |||
| Tangible assets | |||
| Equipment | 15 | 6,634 | 7,119 |
| Financial assets | |||
| Interests in Group companies | 17 | 573 | 573 |
| Deferred tax assets | 16 | 44,391 | 238 |
| Total fixed assets | 51,598 | 7,930 | |
| Current assets | |||
| Inventories | |||
| Finished goods and goods for resale | 3,242 | 702 | |
| Current receivables | |||
| Receivables from parent company | 19 | 207 | 157,908 |
| Trade receivables | 20 | 8,917 | 6,118 |
| Other receivables | 5,500 | 1,884 | |
| Prepayments and accrued income | 21 | 15,613 | 10,925 |
| Total current receivables | 30,237 | 176,835 | |
| Cash and bank deposits | 22 | 716,096 | 56 |
| Total current assets | 749,575 | 177,593 | |
| TOTAL ASSETS | 801,173 | 185,523 |
| KSEK | Note | 31-12-2015 | 31-12-2014 |
|---|---|---|---|
| EQUITY AND LIABILITIES | 2, 23 | ||
| Equity | |||
| Restricted equity | 932 | 583 | |
| Ongoing new share issue | – | 47 | |
| Statutory reserve | 11,327 | 11,327 | |
| Total restricted equity | 12,259 | 11,957 | |
| Unrestricted equity | |||
| Retained earnings | 164,167 | 21,164 | |
| Share premium reserve | 592,565 | 25,017 | |
| Result for the period | -146,421 | 34,210 | |
| Total unrestricted equity | 610,311 | 80,391 | |
| Total equity | 622,570 | 92,348 | |
| liabilities | |||
| Untaxed reserves | |||
| Depreciation/amortization in excess of plan | 2,239 | 1,825 | |
| Tax allocation reserve | – | 15,510 | |
| Total untaxed reserves | 2,239 | 17,335 | |
| Long-term liabilities | |||
| Liability to subsidiaries | 573 | 166 | |
| Total long-term liabilities | 573 | 166 | |
| Short-term liabilities | |||
| Liabilities to Group companies | – | 1,697 | |
| Trade payables | 31,832 | 9,938 | |
| Current tax liability | 9,917 | 9,600 | |
| Other liabilities | 88,088 | 1,287 | |
| Accrued expenses and deferred income | 25 | 45,954 | 53,152 |
| Total short-term liabilities | 175,791 | 75,674 | |
| TOTAL EQUITY AND LIABILITIES | 801,173 | 185,523 |
| KSEK | Note | Share capital |
Other contributed capital |
Retained earnings, including result for the period |
Total equity |
|---|---|---|---|---|---|
| Opening balance at 1 January, 2014 | 583 | 33,617 | 15,847 | 50,047 | |
| Result for the period and comprehensive income | 48,346 | 48,346 | |||
| Transactions with shareholders | |||||
| New share issue | 471) | 25,017 | 25,064 | ||
| Closing balance at 31 December, 2014 | 630 | 58,634 | 64,193 | 123,457 | |
| Opening balance at 1 January, 2015 | 630 | 58,634 | 64,193 | 123,457 | |
| Result for the period and comprehensive income | -159,542 | -159,542 | |||
| Transactions with shareholders | |||||
| Share bonus program for personnel and Board members |
47 | 108,793 | 108,840 | ||
| Direct share issue to the principal owner | 11 | 23,879 | 23,890 | ||
| Direct share issue, public listing | 244 | 554,756 | 555,000 | ||
| Issuance costs, net after deferred tax | -11,088 | -11,088 | |||
| Closing balance at 31 December 2015 | 12 | 932 | 626,181 | 13,444 | 640,557 |
1) On 9 December 2014, 1 867 320 (after split 4:1) outstanding warrants were exercised, corresponding to 1 867 320 (after split 4:1) new shares and an increase in the share capital of SEK 46,683. The subscription price was SEK 53.69 (before the split 4:1) per new share, corresponding to a total of SEK 25,064,103, of which SEK 25,017,420 has been transferred to other contributed capital. The new shares were registered on 9 January, 2015.
| Restricted equity | Unrestricted equity | |||||
|---|---|---|---|---|---|---|
| KSEK | Share capital |
Ongoing new share issue |
Reserv fond |
Statutory reserve |
Retained earnings, including result for the period |
Total equity |
| Opening balance at | ||||||
| 1 January, 2014 | 583 | 0 | 11,327 | 0 | 21,164 | 33,074 |
| Profit/loss for the period and comprehensive income |
34,210 | 34,210 | ||||
| Transactions with shareholders | ||||||
| New share issue | 471) | 25,017 | 25,064 | |||
| Closing balance at 31 December, 2014 |
583 | 47 | 11,327 | 25,017 | 55,374 | 92,348 |
| Opening balance at 1 January, 2015 |
583 | 47 | 11,327 | 25,017 | 55,374 | 92,348 |
| Profit/loss for the period and | ||||||
| comprehensive income | -146,421 | -146,421 | ||||
| Transactions with shareholders | ||||||
| Share bonus program for | ||||||
| personnel and Board | ||||||
| members Direct share issue to the |
47 | 108,793 | 108,840 | |||
| principal owner | 11 | 23,879 | 23,890 | |||
| Direct share issue public | ||||||
| listing | 244 | 554,756 | 555,000 | |||
| Issuance costs, net after deferred tax |
-11,088 | -11,088 | ||||
| New share issue | 47 | -471) | ||||
| Closing balance at 31 December 2015 |
9322) | 0 | 11,327 | 592,565 | 17,746 | 622,570 |
1) On 9 December 2014, 1 867 320 (after split 4:1) outstanding warrants were exercised, corresponding to 1 867 320 (after split 4:1) new shares and an increase in the share capital of SEK 46,683. The subscription price was SEK 53,69 (before the split 4:1) per new share, corresponding to a total of SEK 25,064,103, of which SEK 25,017,420 has been transferred to other contributed capital. The new shares were registered on 9 January, 2015.
2) The change in equity over the year is attributable to the three share issues completed in connection with the listing of the Company's shares on the Nasdaq Stockholm exchange (decided in 2015). One issue was directed to the general public in Sweden, as well as institutional investors, and generated MSEK 555 gross for the company. The other two issues were directed to the participants in the share bonus program as well as to the principal shareholder, Sandberg Development AB (for further information, see Note 24).
| Financial year | ||||
|---|---|---|---|---|
| KSEK | Note | 2015 | 2014 | |
| Operating activities | ||||
| Operating profit/loss before financial items | -204,104 | 62,319 | ||
| Adjustments for non-cash items | 27 | 112,345 | 1,427 | |
| Interest received | 2 | 394 | ||
| Interest paid | -166 | -170 | ||
| Income taxes paid | 317 | 37 | ||
| -91,606 | 64,007 | |||
| Increase/decrease in inventories | -2,539 | 2,986 | ||
| Increase/decrease in trade receivables | -2,800 | 1,672 | ||
| Increase/decrease in other current receivables | -8,511 | -8,278 | ||
| Increase/decrease in trade payables | 21,893 | 2,169 | ||
| Increase/decrease in other current operating liabilities | 77,906 | 6,873 | ||
| Cash flow from changes in working capital | 85,949 | 5,422 | ||
| Cash flow from operating activities | -5,657 | 69,429 | ||
| Investing activities | ||||
| Acquisition of intangible assets | 14 | -355 | -1,828 | |
| Acquisition of tangible assets | 15 | -984 | -5,370 | |
| Divestment/amortization of other financial assets | 406 | – | ||
| Increase/decrease in current financial investments | 157,908 | -87,244 | ||
| Cash flow from investing activities | 156,975 | -94,442 | ||
| Financing activities | ||||
| New share issue | 564,722 | 25,064 | ||
| Cash flow from financing activities | 564,722 | 25,064 | ||
| Net cash flow for the period | 716,040 | 51 | ||
| Cash and cash equivalents at beginning of period | 22 | 56 | 5 | |
| Cash and cash equivalents at end of period | 22 | 716,096 | 56 |
| Financial year | |||
|---|---|---|---|
| KSEK | Note | 2015 | 2014 |
| Operating activities | |||
| Operating profit/loss before financial items | -202,378 | 62,199 | |
| Adjustments for non-cash items | 27 | 110,262 | 1,403 |
| Interest received | 2 | 394 | |
| Interest paid | -167 | -140 | |
| Income taxes paid | 317 | 35 | |
| -91,964 | 63,891 | ||
| Increase/decrease in inventories | -2,539 | 2,383 | |
| Increase/decrease in trade receivables | -2,592 | 1,632 | |
| Increase/decrease in other current receivables | -8,719 | -8,416 | |
| Increase/decrease in trade payables | 21,895 | 2,230 | |
| Increase/decrease in other current operating liabilities | 77,906 | 7,497 | |
| Cash flow from changes in working capital | 85,951 | 5,326 | |
| Cash flow from operating activities | -6,013 | 69,217 | |
| Investing activities | |||
| Acquisition of intangible assets | 15 | -984 | -5,419 |
| Acquisition of tangible assets | – | 28 | |
| Divestment/amortization of other financial assets | – | -1,696 | |
| Divestment in group companies | – | 100 | |
| Increase/decrease in current financial investments | 157,908 | -87,243 | |
| Cash flow from investing activities | 156,924 | -94,230 | |
| Financing activities | |||
| New share issue | 564,724 | 25,064 | |
| Increase/decrease in current financial liabilities | 406 | – | |
| Cash flow from financing activities | 565,130 | 25,064 | |
| Net cash flow for the period | 716,040 | 51 | |
| Cash and cash equivalents at beginning of period | 22 | 56 | 5 |
| Cash and cash equivalents at end of period | 22 | 716,096 | 56 |
The notes on pages 52 for 73 is an integral part of the annual and consolidated accounts.
Camurus AB (publ), reg. No 556667-9105, is an R&D-focused pharmaceutical company. Camurus AB is the parent company of the Camurus Group. Camurus AB hade up until 7 October 2015, Camurus AB's registered offices were in Malmö, Sweden. The company is now based in Lund, Sweden, at Ideon Science Park, 223 70 Lund.
The largest owner of Camurus AB is Sandberg Development AB, reg. Nr. 556091-0712, who accounts for 53,7 percent of the shares. PGS Group AB, reg. Nr. 556301-8745, is the top company in the group, which Camurus AB is consolidated to.
The company's share was listed on Nasdaq Stockholm on 3rd December.
This annual report was subject to approval by the Board on 2016-03-29.
The most important accounting policies that are applied in the preparation of these consolidated financial statements are detailed below. These policies have been applied consequently for all presented periods unless otherwise is stated.
The consolidated financial statements for the Camurus AB Group ("Camurus") have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the EU, as well as the Swedish Financial Reporting Board's Recommendation RFR 1 Supplementary Accounting Rules for Groups, and the Swedish Annual Accounting Act.
Since Camurus prepared consolidated financial statements for the Camurus AB Group in the prospectus, that was published on November 19th, 2015, this annual and consolidated financial statement is not the first financial report prepared in accordance with IFRS.
Camurus adopted IFRS on the 1st of January, 2012. The parent company statements have been prepared in accordance with RFR 2 Accounting for legal entities and the Annual Accounts Act. The parent company's accounting policies are the same as for the Group, unless otherwise stated in Note 2.2. The transition to RFR 2 has not given any effect on the parent company.
Preparing financial statements to conform to IFRS requires use of certain critical accounting estimates. It also requires management to make certain judgments when applying the Group's accounting policies, see note 4.
None of the new standards, changes and interpretations from 1 january 2015 have had any significant impact on the Group's financial reports.
A number of new standards and interpretations enter into force for the financial year starting 1 January, 2015, and have not been applied when preparing this financial report. Below are the standards that are deemed to be of relevance to the Group:
IFRS 9 replaces the multiple classification and measurement models in IAS 39 Financial instruments: Recognition and measurement with a single model that has three classification categories: amortised cost and fair value and a third measurement category (FVOCI) for certain financial assets that are debt instruments.
Classification of debt assets will be driven by the entity's business model for managing the financial assets and the contractual cash flow characteristics of the financial assets. A debt instrument is measured at amortised cost if: a) the objective of the business model is to hold the financial asset for the collection of the contractual cash flows, and b) the contractual cash flows under the instrument solely represent payments of principal and interest.
All other debt and equity instruments, including investments in complex debt instruments and equity investments, must be recognised at fair value.
All fair value movements on financial assets are taken through the statement of profit or loss, except for equity investments that are not held for trading, which may be recorded in the statement of profit or loss or in reserves (without subsequent recycling to profit or loss). For financial liabilities that are measured under the fair value option entities will need to recognise the part of the fair value change that is due to changes in the their own credit risk in other comprehensive income rather than profit or loss.
The new hedge accounting rules (released in December 2013) align hedge accounting more closely with common risk management practices. As a general rule, it will be easier to apply hedge accounting going forward. The new standard also introduces expanded disclosure requirements and changes in presentation.
IFRS 9 also introduced a new expected credit loss (ECL) model which involves a three-stage approach whereby financial assets move through the three stages as their credit quality changes. The stage dictates how an entity measures impairment losses and applies the effective interest rate method. A simplified approach is permitted for financial assets that do not have a significant financing component (eg trade receivables). On initial recognition, entities will record a day-1 loss equal to the 12 month ECL (or lifetime ECL for trade receivables), unless the assets are considered credit impaired.
For financial years commencing before 1 February 2015, entities can elect to apply parts of IFRS 9 earlier according to specific transition rules. After 1 February 2015, the new rules must be adopted in their entirety.
The group intends to apply the new standard by the financial year beginning 1 January 2018, and has not yet evaluated the effects. The standard is not yet adopted by EU.
The IASB has issued a new standard for the recognition of revenue. This will replace IAS 18 which covers contracts for goods and services and IAS 11 which covers construction contracts. The new standard is based on the principle that revenue is recognised when control of a good or service transfers to a customer – so the notion of control replaces the existing notion of risks and rewards.
A new five-step process must be applied before revenue can be recognised:
Key changes to current practice are:
success of an outcome etc) – minimum amounts must be recognised if they are not at significant risk of reversal.
Entities will have a choice of full retrospective application, or prospective application with additional disclosures. The group intends to apply the new standard by the financial year beginning 1 January 2018, and has not yet evaluated the effects. The standard is not yet adopted by EU.
In January 2016, IASB issued a new lease standard that will replace IAS 17 Leases and the related interpretations IFRIC 4, SIC-15 and SIC-27. The standard requires assets and liabilities arising from all leases, with some exceptions, to be recognized on the balance sheet. This model reflects that, at the start of a lease, the lessee obtains the right to use an asset for a period of time and has an obligation to pay for that right. The accounting for lessors will in all material aspects be unchanged. The standard is effective for annual periods beginning on or after 1 January 2019. Early adoption is permitted. EU has not yet adopted the standard. The group has not yet assessed the impact of IFRS 16.
None of the other IFRS or IFRIC interpretations that have yet to enter into force are expected to be of relevance to, or have any material impact on the Group.
Subsidiaries are all companies (including structured entities) over which the Group has a controlling interest. The Group controls a company when it is exposed or entitled to variable returns from its holding in the company and has the opportunity to influence the return through its interest in the company. Subsidiaries are consolidated from the date on which control is transferred to the Group. They are deconsolidated from the date that control ceases.
The Group uses the acquisition method to recognize the Group's business combinations. The purchase price for the acquisition of a subsidiary comprises the fair value of transferred assets, liabilities incurred by the Group to former owners of the acquired company and the shares issued by the Group. The purchase price also includes the fair value of all liabilities resulting from a contingent consideration arrangement. Identifiable acquired assets and liabilities assumed in a business combination are measured initially at their fair values on the acquisition date.
Acquisition-related costs are expensed as they arise.
Inter-company transactions, balance sheet items, income and expenditure on transactions between Group companies are eliminated. Profit and losses resulting from inter-company transactions and that are recognized in assets are also eliminated. The accounting policies for subsidiaries have been amended, where applicable, to ensure consistent application of the Group's policies.
The items 'Receivables from Group companies' and 'Liabilities to Group companies' in the consolidated balance sheet concern receivables and liabilities to the parent company Sandberg Development AB.
The functional currency of the parent company is the Swedish krona (SEK), which is also the presentation currency of the Group. This means that the financial statements are presented in SEK. Unless otherwise stated, all amounts are given and rounded to the nearest thousand (KSEK).
Foreign currency transactions are translated into the functional currency using the exchange rates prevailing on the transaction date. Exchange gains and losses arising on payment of such transactions and on translation of monetary assets and liabilities denominated in foreign currencies at the exchange rate on the balance sheet date are recognized in operating profit in the income statement.
The earnings and financial position of all Group companies with a functional currency that differs from the presentation currency are translated into the Group's presentation currency. Assets and liabilities for each balance sheet are translated from the foreign operation's functional currency into the Group's presentation currency, SEK, at the exchange rate on the balance sheet date. Income and expenditure for each income statement are translated into SEK at the average exchange rate prevailing at the point of each transaction. Translation differences arising when translating the data of foreign operations are recognized in other comprehensive income.
Operating segments are reported in the same way as internal reporting, which is submitted to the highest executive decision maker. The highest executive decision maker is the function responsible for allocating resources and assessing the operating segments' results. In the Group this function is identified as the CEO, who makes strategic decisions in consultation with the Board.
The Group conducts research and development relating to new products. The overall level of risk associated with current development projects is high. The risk comprises technical and manufacturing-related risks, safety and effect-related risks that can arise in clinical studies, regulatory risks relating to applications for approval of clinical studies and market approval, as well as IP risks relating to approval of patent applications and patent protection. All development work is therefore treated as research (since the work does not meet the criteria listed below), until the point at which the product has been granted market approval. Research expenditure is expensed as it occurs.
Expenses directly attributable to development and testing of identifiable and unique products controlled by the Group are recognized as intangible assets once the following criteria have been satisfied:
Capitalized assets that have satisfied the capitalization criteria above have a limited useful life and are carried at cost less accumulated amortization. Amortization is initiated once the asset is ready for use. Amortization is conducted on a straightline basis to distribute the cost of the proprietary intangible assets over their estimated useful life, which coincides with the product's remaining patent period.
Directly attributable costs that are capitalized include development expenditure, as well as personnel costs and a reasonable proportion of indirect costs. Other development expenditure that does not satisfy the above criteria is expensed as it arises. Development expenses that have been previously expensed are not recognized as assets in the subsequent period.
Property, plant and equipment are recognized at cost less depreciation. The cost of acquisition includes expenditures that can be related directly to the acquisition of the asset.
Additional expenses are added to the asset's carrying amount or recognized as a separate asset, depending on which is appropriate, only when it is likely that the future economic benefits associated with the asset will be of use to the Group, and the cost of the asset can be reliably measured. The carrying amount of a replaced part is derecognized from the balance sheet. All other forms of repair and maintenance are recognized as costs in the income statement in the period in which they arise.
Depreciation is carried out on a straight-line basis as follows: Equipment 4–8 years
The assets' residual values and useful lives are reviewed at the end of each reporting period and adjusted if required. An asset's carrying amount is written down immediately to its recoverable amount if the asset's carrying amount is greater than its estimated recoverable amount. Gains and losses on disposal of property, plant or equipment are determined by comparing sales proceeds with the carrying amount and are recognized in other operating income or other operating expenses in the income statement.
Intangible assets that have an indeterminable useful life or intangible assets that are not ready for use are not subject
to amortization but are tested annually for impairment. Assets subject to amortization are reviewed for impairment in value whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognized at the amount by which the asset's carrying amount exceeds its recoverable amount. The recoverable amount is the higher of the asset's fair value less distribution costs and its value in use. For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units). For assets previously impaired, a review is conducted every balance sheet date as to whether a reversal should be carried out.
Inventories are carried at the lower of cost and net realizable value. Cost is established via the First In First Out method, (FIFO). The net realizable value is the estimated selling price in the ordinary course of business less applicable variable distribution costs.
The Group classifies its financial assets and liabilities into the following categories: loans and trade receivables, and other financial liabilities. The classification depends on the purpose for which the financial asset or liability is acquired.
Loans and receivables are non-derivative financial assets, with fixed or determinable payments, that are not quoted in an active market. They are included in current assets, with the exception of items with maturities extending 12 months beyond the balance sheet date; these are classified as fixed assets. The Group's loans and receivables comprise trade receivables, cash and cash equivalents and the financial instruments that are reported in other receivables.
Liabilities to Group companies, trade payables and the part of other current liabilities that concerns financial instruments are classified as other financial liabilities.
The Group's financial instruments are initially measured at fair value plus transaction costs. Financial assets are removed from the balance sheet when the right to receive cash flows from the instrument expires or is transferred and the Group has transferred virtually all risks and rewards of ownership. Financial liabilities are removed from the balance sheet when the obligation in the agreement has been completed or in some other way eliminated.
Loans and receivables and other financial liabilities are recognized after the date of acquisition at amortized cost using the effective interest method.
Financial assets and liabilities are offset and recognized in the balance sheet at a net amount, only when a legal right exists to offset the recognized amounts and there is an intention to settle them at a net amount, or to realize the asset and settle the liability at the same time.
The Group performs an assessment at the end of each reporting period of whether there is objective evidence that a financial asset or group of financial assets is impaired. A financial asset or group of financial assets is impaired only if there is objective evidence of an impairment need due to one or more events occurring after the point at which the asset was initially recognized, and this event/these events has an impact on the estimated future cash flows for the financial asset or group of financial assets that can be reliably estimated. The impairment is calculated as the difference between the asset's carrying amount and the present value
of estimated future cash flows, discounted to the financial asset's original effective interest rate. The asset's carrying amount is impaired and the impairment amount is recognized in the consolidated income statement within operating profit or within net financial income/expense, depending on the kind of financial asset that is being impaired. If the impairment requirement decreases in a subsequent period and the decrease can be objectively attributed to an event that occurred after the impairment was recognized, the reversal of the previously recognized impairment is recognized in the consolidated income statement within operating profit or within net financial income/expense, depending on the kind of financial asset that is being impaired.
Trade receivables are financial instruments comprising amounts that are due to be paid by customers for goods and services sold in the ordinary course of business. Payments expected within one year or less are classified as current assets. Otherwise they are recognized as fixed assets. Trade receivables are initially recognized at fair value and thereafter at amortized cost using the effective interest method, less any provision for decrease in value.
Cash and cash equivalents are financial instruments and comprise cash and bank balances.
Ordinary shares are classified as equity. Transaction costs directly attributable to the issue of new ordinary shares or warrants are recognized, net after tax, in equity as deductions from the issue proceeds.
When the warrants are exercised, the company issues new shares. Payments received are credited to the share capital (quota value) and other contributed capital.
Trade payables are financial instruments and relate to obligations to pay for goods and services that have been acquired in the ordinary course of business. Trade payables are classified as current liabilities if they are payable within one year. Otherwise they are recognized as long-term liabilities. Trade payables are initially recognized at fair value, and thereafter at amortized cost using the effective interest method.
Tax expense for the period includes current income tax and deferred tax. The current income tax expense is calculated on the basis of the tax regulations that are enacted or substantively enacted on the balance sheet date in countries where the parent company and its subsidiaries operate and generate taxable revenue. Deferred tax is recognized using the balance sheet method, on all temporary differences arising between the tax base of assets and liabilities and their carrying amounts in the consolidated accounts. Deferred income tax is determined using the tax rates enacted or announced by the balance sheet date and that are expected to apply when the related deferred tax asset is realized or the deferred tax liability is settled. Deferred tax assets on loss carryforwards are recognized to the extent that it is likely future taxable surpluses will be available, against which the losses can be utilized.
Deferred tax assets and tax liabilities are offset when a legally enforceable right to offset exists for current tax assets and liabilities, the deferred tax assets and liabilities refer to taxes charged by one and the same tax authority and relate either to the same taxable entity or different taxable entities and there is an intention to settle the balances using net payments.
The Group has defined contribution pension schemes, as well as defined benefit Alecta plans. All plans are recognized as defined contribution plans. The plan extends to all employees, including the Group CEO and senior executives.
A defined contribution plan is a pension plan under which the Group pays fixed contributions into a separate legal entity. The Group does not have any legal or informal obligation to pay additional contributions if this legal entity does not have sufficient assets to pay all benefits to employees attached to the employees' service during the current or previous periods.
For defined contribution plans, the Group pays contributions to public or privately administered pension insurance plans on a mandatory, contractual or voluntary basis. The Group has no additional payment obligations once the contributions have been paid. The contributions are recognized as personnel costs when they fall due for payment. Prepaid contributions are recognized as an asset to the extent that cash repayment or reduction of future payments may benefit the Group.
For salaried employees in Sweden, the ITP 2 plan's defined benefit pension obligations for retirement pension and family pension are secured through insurance held at Alecta. A defined benefit plan is a pension plan that is not a defined contribution plan. Defined benefit plans differ in that they define an amount of pension benefit that an employee will receive on retirement, usually dependent on one or more factors such as age, years of service and salary.
As per UFR 10 Classification of ITP plans financed by insurance in Alecta (a statement issued by the Swedish Financial Reporting Board), this is a multi-employer defined benefit plan. The Company has not had access to information for the period in order to report its proportional share of the plan's commitments, plan assets and costs, which has meant that it has not been possible to recognize the plan as a defined benefit plan.
The ITP 2 pension plan, secured through insurance held at Alecta, is thus recognized as a defined contribution plan. The premium for the defined benefit retirement and family pension is calculated individually and depends on such factors as salary, previously earned pension and expected remaining period of service.Anticipated contributions the next reporting period for ITP 2 insurance with Alecta amount to MSEK 1,3 million (2014: MSEK 1,0 million, 2013: MSEK 1,0 million). The Group's share of the total contributions to the plan is not significant.
The collective consolidation level comprises the market value of Alecta's assets as a percentage of the insurance obligations, calculated in accordance with Alecta's actuarial methods and assumptions, which does not correspond with IAS 19. The collective consolidation level is normally allowed to vary between 125 and 155 percent. If Alecta's collective consolidation level falls short of 125 percent or exceeds 155 percent, measures will be taken to create conditions to restore the consolidation level to the normal interval. In the event of low consolidation, a possible measure might be to raise the agreed price of new subscription and extension of existing benefits. In the event of high consolidation, a possible measure might be to introduce premium reductions. At the end of 2015 Alecta's surplus (in the form of the collective consolidation level) was 153 percent (2014: 143 percent, 2013: 148 percent).
Revenue is measured at the fair value of what has been received or will be received, and corresponds to the amounts received for sold goods and services, less deductions for discounts and value added tax. The Group recognizes revenue when its amount can be reliably measured, it is probable that the future economic benefits associated with the transaction will flow to the company, and certain criteria have been satisfied for each of the Group's operations as described below.
Revenue from agreements that are made with customers in research projects is recognized based on the financial implications of the agreement. Revenue from license and collaboration agreements may consist of one-off payments, license, royalty and milestone payments and remuneration for research services. In addition, under the agreements Camurus may also be entitled to compensation for costs incurred. Revenue recognition reflects earnings in accordance with the specific contractual terms.
Camurus applies the criteria for revenue recognition on each individual transaction. However, in some situations it is necessary to apply the criteria to those parts of a transaction that can be separately identified, so that the financial implications of the transaction can be reflected in the financial statements. This means, for example, that the various transactions in the agreements are divided up and that identifiable parts are recognized separately. If the total value of the agreement falls short of the fair value of the transactions' separate parts, the difference ('discount') is allocated among the separate parts based on their relative fair values in the transaction.
The principles for revenue recognition of different parts (and for corresponding separate transactions) in license and collaboration agreements are described below:
An assessment is made as to whether the license acquired by the counterparty in the agreement means that the intangible asset has been divested from an accounting perspective (i.e. as a sold license, where the counterparty appropriates the asset), or whether it gives the counterparty a right to utilize the intangible asset.
The assessment is made based on the financial implications of the agreement. An assignment of licensing rights for a fixed fee under a non-cancellable agreement allowing the licensee to freely utilize Camurus' rights, and where Camurus does not have any remaining obligations to perform, is essentially regarded as a sale. If the agreement means that the intangible
asset has been divested and satisfies the criteria for revenue recognition of a good, revenue recognition is carried out in accordance with the principles for goods sold (see 'Sale of goods' below). If the agreement does not constitute a divestment of the intangible asset, the customer has right of use and remuneration is normally allocated on a straightline basis over the term of the agreement.
Revenue from the sale of goods is recognized when significant risks and benefits associated with ownership of the goods has been transferred and Camurus no longer has any commitment in the ongoing management of business operations that is normally associated with ownership, and neither does the company exercise any real control over the sold goods. Furthermore, it must be possible to calculate the revenue in a reliable way, it should be likely that the economic benefits associated with the transaction will accrue to the company and the expenses that have arisen, or that are expected to arise as a result of the transaction, can be reliably calculated. In Camurus' case this usually means that goods are recognized as income on delivery to the customer.
Regular remuneration is received for research services, often in advance as a fixed amount. Research remuneration received is recognized in the period in which the services are carried out. Revenue is calculated by establishing the degree of completion for the transaction in question based on the proportion the services rendered represent of the total services to be performed. Research services performed on an open account basis are recognized as income as the services are carried out.
Remuneration in the form of royalties is recognized as revenue when it is likely that the economic benefits associated with the transaction will accrue to Camurus and the revenue can
be reliably calculated. Royalties are accrued as per the relevant agreement's financial implications. In some cases the royalties received are dependent upon a future event, for example future sales. In such cases, revenue from royalties is recognized when it is likely that the royalty remuneration will be received, usually in connection with the future sale.
Remuneration received when milestones are achieved is recognized as revenue when it is likely that the economic benefits associated with the transaction will accrue to Camurus and the revenue can be reliably calculated. Payments for milestones are received when a certain result has been achieved, or a particular event has occurred in accordance with definitions in the respective collaboration agreement. Revenue for milestones is recognized when all terms for the right to remuneration in accordance with the agreement have been met, usually in connection with the contractually agreed milestone being achieved, and Camurus has satisfied all conditions for the milestone in accordance with the collaboration agreement.
Compensation for costs incurred, i.e. costs that are forwarded onto the customer, is recognized in accordance with the guidance under IAS 18 for determining whether an entity is acting as a principal or as an agent. This means that Camurus analyses whether the Company is acting as a principal in the transaction, i.e. that Camurus is exposed to the significant risks and benefits on the sale of a good or service. If Camurus is a principal in the transaction, the amount received from the counterparty is recognized as revenue. If Camurus is acting as an agent, the revenue instead comprises commission received.
Interest income is recognized as revenue using the effective interest method. When the value of a claim in the category 'Loans and receivables' has fallen, the Group reduces the carrying amount to the recoverable value, which comprises estimated future cash flow, discounted with the original effective interest rate for the nstrument, and continues to dilute the discounting effect as interest income. Interest income on impaired loans and receivables is recognized at the original effective interest rate.
Until December 3, 2015, the group had a share-based compensation plan where the regulation should be made in shares and where the company received services from employees as consideration for the Group's own equity instruments (shares). The fair value of the service, which eligible employees to the allocation of shares, was expensed and the total amount to be expensed was based on the fair value of the shares granted.
At the end of each reporting period, the Group reviews its assessments of how many shares is expected to be earned. Any deviation from the original assessments brought about by the review is recognized in the income statement and corresponding adjustments are made against Equity.
When bonus shares were exercised, the Company issued new shares. The proceeds received net of any directly attributable transaction costs are credited to share capital (quota value) and other capital contributions.
The social security contributions arising on the allocation of the share-based payment are treated as an integral part of the allocation, and the cost is treated as a cash-settled, share-based payment.
Until December 3, 2015, the group had a share-based compensation plan where the regulation should be made in shares and where the company received services from employees as consideration for the Group's own equity
instruments (shares). The fair value of the service, which eligible employees to the allocation of shares, was expensed and the total amount to be expensed was based on the fair value of the shares granted.
At each reporting period Camurus assessed its estimates of the number of shares expected to vest based on the nonmarket vesting conditions and service conditions. Any deviation from the original estimates as the review gave rise to, were recognized in the income statement and corresponding adjustments made to equity.
When bonus shares were exercised, the Company issued new shares. The proceeds received net of any directly attributable transaction costs are credited to share capital (quota value) and other capital contributions.
The social security contributions which arose on the allocation of the shares was regarded as an integral part of the award, and the cost was treated as a cash-settled share-based payment.
The deferred tax receivable has been calculated on the basis of the management's and Board of Directors' judgement of the future utilisation of the consolidated accumulated deficits within the foreseeable future.
The cash flow statement has been prepared in accordance with the indirect method. This means that the operating profit is adjusted for transactions that have not involved incoming payments or disbursements during the period, and for any revenue and expenses relating to the cash flows of investing or financing activities. The Group-wide account for cash management (cash pool) is not included in cash and cash equivalents but is instead recognized in the balance sheet in transactions with the principal shareholder Sandberg Development AB, and the change in the item is reflected in the cash flow statement as investing activity.
In connection with the transition to reporting according to IFRS in the consolidated accounts, the parent company adopted, RFR 2 Accounting principles for legal entities. The Parent Company's principles are consequently consistent with those of the Group, unless otherwise stated below.
The income statement and balance sheet follow the Swedish Annual Accounting Act statement. Statement of changes in equity follows the group format but contains the columns listed in the Swedish Annual Accounts Act. The formats for the parent company gives a difference in designation, compared with the consolidated financial statements, primarily related to financial income and expenses and items within equity.
Interests in subsidiaries are reported at cost, less any impairment losses. The cost includes acquisition-related expenses and any additional considerations. When there is an indication that interests in subsidiaries have decreased in value, a calculation is made of the recoverable amount. If this amount is lower than the reported amount, an impairment is carried out.
The company applies the alternative rule in accordance with RFR 2 Accounting principles for legal entities, and, consequently, recognizes Group contributions received/paid as appropriations.
IAS 39 is not applied in the parent company and financial instruments are measured at cost. In subsequent periods, the financial assets that are acquired with the intention of being held on short-term, will be accounted for in accordance with the lowest value principle at the lower of acquisition cost and market value. At each balance sheet date, the parent company assesses whether there is any indication of impairment in any of the financial assets. Impairment is recognized if the impairment is deemed to be permanent.
Impairment of interest-bearing financial assets, recognized at amortized cost, is calculated as the difference between the asset's carrying amount and the present value of management's best estimate of future cash flows discounted at the asset's original effective interest rate.
The impairment amount of other financial assets is determined as the difference between the carrying value and the higher of fair value less costs to sell and the present value of future cash flows (which are based on management's best estimate).
As a result of its business, the Group is exposed to a number of different risks: market risk (including foreign exchange risk), credit risk and liquidity risk. The Group has decided not to actively manage its risks through the use of derivatives, for example.
The most significant market risk for the Group is the foreign exchange risk, which is described in a separate section below. The interest rate risk is limited within the Group, as there is no long-term borrowing or long-term interest-bearing investment.
The Group operates internationally and is exposed to foreign exchange risks arising from various currency exposures, primarily relating to the US dollar (USD) and euro (EUR). The foreign exchange risk arises through future finance transactions, recognized assets and liabilities. Foreign exchange risks arise when future finance transactions or recognized assets or liabilities are expressed in a currency that is not the functional currency of the entity.
The Group has the following balance sheet exposure for assets, which include trade receivables and cash and
| cash equivalents (KSEK) | 31-12-2015 | 31-12-2014 |
|---|---|---|
| USD | 41,923 | 5,296 |
| EUR | 4,543 | 779 |
| Other currencies | 210 | 89 |
| Total | 46,676 | 6,164 |
| for trade payables is as follows (KSEK) |
31-12-2015 | 31-12-2014 |
|---|---|---|
| USD | -2,228 | -4,964 |
| EUR | -5,081 | -1,855 |
| GBP | -1,315 | -313 |
| Other currencies | -344 | – |
| Total | -8,968 | -7,132 |
Had the Swedish krona weakened/strengthened by 5 percent in relation to the US dollar, with all other variables remaining constant, the recalculated profit/loss for the year and equity at 31 December 2015, would have been SEK 1,5 (0) MSEK higher/lower. Changes to SEK in relation to EUR and GBP are not deemed to have any material impact on profit/loss for the year.
Credit risk exists through cash and cash equivalents and cash balances with banks and financial institutions, and credit exposures to customers, wholesalers and retailers, including outstanding receivables and committed transactions. Only banks and financial institutions that are among the four largest Swedish banks according to Standard & Poor's rating list are accepted.
Before an agreement is entered into, the Group's customers are subjected to a credit assessment, whereupon information about the customer's financial position is accessed from various credit assessment companies. The overall assessment also considers other factors. The customer's financial position is also followed up and continually monitored. Trade receivables are continually followed up with checks on overdue invoices. Management does not expect any losses resulting from non-payment as the Group's counterparties mainly comprise major companies, which is why the credit risk is currently deemed to be low.
The Group closely monitors rolling forecasts for its liquidity reserve to ensure that the Group has sufficient cash funds to meet requirements in the ordinary course of business.
The table below analyses the Group's non-derivative financial liabilities classified by the time that, on the balance sheet date, remained until the contractually agreed maturity date. The amounts given in the table are the contractually agreed undiscounted cash flows.
| Group, 31 december 2015 |
Up to one month |
1–3 months |
3 months –1 year |
1–5 years |
|---|---|---|---|---|
| Liabilities to Group companies |
– | – | – | – |
| Trade payables Other short-term |
21,948 | 9,883 | – | – |
| liabilities | 191 | – | – | – |
| Summa | 22,139 | 9,883 | – | – |
| Group, 31 december 2014 |
Up to one month |
1–3 months |
3 months –1 year |
1–5 years |
| Liabilities to Group companies |
1,697 | – | – | – |
| Trade payables | 9,938 | – | – | – |
| Other short-term liabilities |
191 | – | – | – |
The aim of the Group regarding capital structure is to ensure the Group's ability to continue its operations so that it can continue to generate a return for shareholders and benefit for other stakeholders, as well as maintaining an optimal capital structure to keep costs of capital down.
To maintain or adjust the capital structure, the Group can issue new shares or sell assets to reduce debt.
The Group is mainly engaged in research and development activities. Operations have been financed through capital contributions from the parent company Sandberg Development AB, as well as through earnings generated from successful research and development projects. Equity is therefore viewed as the Group's capital.
The Group does not hold any instruments that are measured at fair value. The fair value of current receivables and liabilities corresponds to their carrying amounts, since discounting effects are minimal.
Estimates and assessments are evaluated continually and are based on historic experience and other factors, including expectations of future events that are judged reasonable under prevailing conditions.
Group management makes estimates and assumptions concerning the future. There is a risk that the estimates made for accounting purposes do not corresponding to the actual result. The estimates and assumptions that involve a significant risk of material adjustments to carrying value of assets and liabilities within the next coming financial year, are outlined in brief below.
Camurus has complex customer agreements and the management must make assessments and estimates when applying revenue recognition principles. The section entitled 'Accounting policies' regarding revenue details the areas for which assessments and estimates need to be carried out. Key areas in the assessment include the division of agreements in various sub-transactions, how the price of these transactions should be allocated, the point in time at which transactions should be recognized and the way in which the transaction should be recognized (on a single occasion or over a period of time). Camurus also needs to decide whether an agreement that includes a license to utilize Camurus' intellectual property constitutes a sale of the license in the form of a good that is recognized as revenue on delivery, or whether the agreement constitutes right of use, which is recognized as revenue over time. The assessments made by management affect the period in which, and amount at which the revenue is recognized.
The Group capitalizes costs attributable to product development projects to the extent that they are deemed to satisfy the criteria in accordance with IAS 38 p. 57 (see note 1.6 Intangible assets).
Intangible assets that are not ready for use are not subject to amortization but are tested annually for impairment. Impairment testing for capitalized development costs has therefore been carried out to ensure that the carrying amount does not exceed the recoverable amount. The material assumptions used for calculations of value in use include:
Company management also makes judgments and estimates regarding the possibility of utilizing incurred losses and temporary differences as the basis for the reported tax receivable.
Company management have established that the Group as a whole constitutes one segment based on the information managed by the CEO, in consultation with the Board, and which is used as a basis for allocating resources and evaluating results.
| To follow is a breakdown of external revenues from all products and services |
Group | Parent company | ||
|---|---|---|---|---|
| 2015 | 2014 | 2015 | 2014 | |
| Sales of development-related goods and services |
93,845 | 33,674 | 93,845 | 33,449 |
| Milestone payments | 52,850 | 18,025 | 52,850 | 18,025 |
| License fees | 7,238 | 153,687 | 7,238 | 153,687 |
| Other | 866 | 2,821 | 866 | 2,821 |
| Total | 154,799 | 208,207 | 154,799 | 207,982 |
| Revenues from external customers is allocated by country, based on where the customers are located |
Group | Parent company | |||
|---|---|---|---|---|---|
| 2015 | 2014 | 2015 | 2014 | ||
| Europe (of which Sweden) |
108,067 (2,275) |
202,333 (47) |
108,067 (2,275) |
202,108 (34) |
|
| North Amerika | 39,635 | 5,697 | 39,635 | 5,697 | |
| Other geographical areas | 7,097 | 177 | 7,097 | 177 | |
| Total | 154,799 | 208,207 | 154,799 | 207,982 |
Revenues during 2015 of approximately MSEK 79,4 (128,8 MSEK) relates to a single external customer. All fixed assets are located in Sweden.
Operating expenses are presented in the statement of comprehensive income with a classification based on the functions 'Cost of sales', 'Marketing and distribution costs', 'Administrative expenses' and 'Research and development costs'. The total costs by function were allocated according to the following cost items.
| Group | Parent company | |||
|---|---|---|---|---|
| Allocation by cost item | 2015 | 2014 | 2015 | 2014 |
| Changes in stock of finished goods and work in progress |
2,539 | 2,383 | 2,539 | 2,383 |
| Raw materials and consumable supplies |
729 | 427 | 729 | 427 |
| Other external expenses 1) 2) | 155,885 | 90,278 | 156,242 | 90,199 |
| Costs of premises, including laboratory costs |
16,032 | 13,520 | 16,032 | 13,520 |
| Costs relating to employee benefits 2) 3) (note 9) |
179,566 | 40,332 | 179,566 | 40,332 |
| Depreciation, amortization and impairment losses (note 14 and 15) |
3,552 | 1,429 | 1,469 | 1,403 |
| Total cost of sales, research and development, sales and administration |
358,303 | 148,369 | 356,577 | 148,264 |
1) This item includes costs that form the basis for research and development projects.
2) Costs incurred for partner-financed activities within research and development during the period have most essentially matched the size of the revenue. See also note 5 Segment information and the item'Sales of development-related goods and services'.
3) This item also includes the Share bonus program amounting to 139,7 MSEK.
| Group | Parent company | |||
|---|---|---|---|---|
| Other operating income | 2015 | 2014 | 2015 | 2014 |
| Exchange gains | – | 2,423 | – | 2,423 |
| Other items | 57 | 58 | 57 | 58 |
| Total other operating income | 57 | 2,481 | 57 | 2,481 |
| Group | Parent company | |||
|---|---|---|---|---|
| Average no. of employees | 2015 (of which women) |
2014 (of which women) |
2015 (of which women) |
2014 (of which women) |
| Sweden | 44 (29) | 38 (24) | 44 (29) | 38 (24) |
| Total | 44 | 38 | 44 | 38 |
| Group | Parent company | |||
|---|---|---|---|---|
| Audit and other assignments | 2015 | 2014 | 2015 | 2014 |
| PwC | ||||
| Auditing assignment | 325 | – | 325 | – |
| Other assignments | 2,418 | – | 2,418 | – |
| Total | 2,743 | 0 | 2,743 | 0 |
| Mazars SET Revisionsbyrå AB | ||||
| Auditing assignment | 280 | 210 | 280 | 205 |
| Other assignments1) | 661 | 72 | 661 | 72 |
| Total | 941 | 282 | 941 | 277 |
1) Refers to various quality assuring services in connection with the company's listing.
| Gender distribution in the Group* for Board members and other senior management Number on balance sheet date (of which women) |
Group | Parent company | ||
|---|---|---|---|---|
| 2015 | 2014 | 2015 | 2014 | |
| sheet date (of which women) | 2015 | 2014 | 2015 | 2014 |
|---|---|---|---|---|
| Board members 1) | 9 (2) | 7 (–) | 9 (2) | 7 (–) |
| CEO and other senior management | 8 (3) | 5 (2) | 8 (3) | 5 (2) |
1) The CEO, who is a board member, is also reported as CEO.
| * incl. Subsidiaries. | |||||
|---|---|---|---|---|---|
| -- | -- | ----------------------- | -- | -- | -- |
| Salaries, other remuneration and social costs |
Group | Parent company | ||
|---|---|---|---|---|
| 2015 | 2014 | 2015 | 2014 | |
| Salaries and other compensation | 133,351 | 26,834 | 133,351 | 26,834 |
| Social security | 39,963 | 8,236 | 39,963 | 8,236 |
| Pension expenses – defined contribution plans |
6,251 | 4,332 | 6,251 | 4,332 |
| Total | 179,566 | 39,402 | 179,566 | 39,402 |
| Salaries and other remuneration (of which bonus) |
Group | Parent company | |||
|---|---|---|---|---|---|
| 2015 | 2014 | 2015 | 2014 | ||
| Board members, CEO and other senior management |
56 313 (1 827) |
6 626 (1 732) |
56 313 (1 827) |
6 626 (1 732) |
|
| Other employees | 77 038 | 20 208 | 77 038 | 20 208 | |
| Total | 133 351 | 26 834 | 133 351 | 26 834 |
The above remuneration includes the cost for the share-based bonus program which materialized in connection with the listing of the company's share on December 3, 2015. See note 24 and 28.
| Group | Parent company | |||
|---|---|---|---|---|
| Pension expenses | 2015 | 2014 | 2015 | 2014 |
| Board members, CEO and other senior management |
2,365 | 1,583 | 2,365 | 1,583 |
| Other employees | 3,886 | 2,749 | 3,886 | 2,749 |
| Total | 6,251 | 4,332 | 6,251 | 4,332 |
The above salaries and remuneration do not include invoiced services from the Board and senior management. For remuneration and other benefits to the Board and senior management, see note 28 Related party transactions. See also note 24 Share based payment.
| Group | Parent company | |||
|---|---|---|---|---|
| 2015 | 2014 | 2015 | 2014 | |
| Income tax: | ||||
| Income tax on profit for the year | – | -10,237 | – | -10,237 |
| Total current tax | 0 | -10,237 | 0 | -10,237 |
| Deferred tax (see note 16) | 44,727 | -3,960 | 41,026 | 39 |
| Total deferred tax | 44,727 | -3,960 | 41,026 | 39 |
| Income tax | 44,727 | -14,197 | 41,026 | -10,198 |
The income tax on profit differs from the theoretical amount that would have resulted from the use of a weighted average tax rate for earnings in the consolidated companies in accordance with the following:
| Group | Parent company | |||
|---|---|---|---|---|
| 2015 | 2014 | 2015 | 2014 | |
| Profit/loss before tax | -204,268 | 62,543 | -187,447 | 44,408 |
| Income tax is calculated in accordance with the national tax rates in force prior to the results in each country |
44,939 | -13,759 | 41,238 | -9,770 |
| Tax effects of: | ||||
| - Non-taxable revenue | 0 | 0 | 0 | 0 |
| - Non-deductible expenses | -190 | -56 | -190 | -428 |
| - Imputed tax on allocations | -22 | – | -22 | – |
| - Tax loss for which no deferred tax asset has been recognized |
– | -382 | – | – |
| Recognised effective tax | 44,727 | -14,197 | 41,026 | -10,198 |
Weighted average tax rate for the Group is 21,9 percent (22,7 percent) and for the Parent company 21,9 percent (23,0 percent).
| Group | Parent company | |||
|---|---|---|---|---|
| Finance income | 2015 | 2014 | 2015 | 2014 |
| Interest income, cash pool | 1 | 394 | 1 | 394 |
| Interest income, cash pool | 1 | – | 1 | – |
| Finance income | 2 | 394 | 2 | 394 |
| Finance expenses | ||||
| Interest expenses, cash pool | -17 | -168 | -17 | -138 |
| Interest expenses, other | -149 | -2 | -149 | -2 |
| Finance expenses | -166 | -170 | -166 | -140 |
| Total financial items – net | -164 | 224 | -164 | 254 |
Earnings per share before dilution is calculated by dividing the result attributable to shareholders of the parent company by a weighted average number of ordinary shares outstanding during the period. During the period, no shares held as treasury shares by the parent company have been repurchased.
| 2015 | 2014 | |
|---|---|---|
| Result attributable to parent company shareholders | -159,542 | 48,346 |
| Weighted average number of ordinary shares outstanding (thousands) |
26,497 | 23,459 |
In order to calculate earnings per share, the number of existing ordinary shares is adjusted for the dilutive effect of the weighted average number of outstanding ordinary shares. The parent company has one category of ordinary shares with anticipated dilution effect in the form of warrants. For warrants, a calculation is made of the number of shares that could have been purchased at fair value (calculated as the average market price for the year for the parent company's shares), at an amount corresponding to the monetary value of the subscription rights linked to outstanding warrants. The number of shares calculated as above is compared to the number of shares that would have been issued assuming the warrants are exercised.
For further information related to warranty program, please see Note 28 Related party transactions.
| 2015 | 2014 | |
|---|---|---|
| Result attributable to parent company shareholders | -159,542 | 48,346 |
| Weighted average number of ordinary shares outstanding (thousands) |
26,497 | 23,459 |
| Adjustments: | ||
| - warrants (thousands) | 1,047 | 1,749 |
| - share issues (thousands) | 9,737 | – |
| Weighted average no. of ordinary shares used in calculation of earnings per share after dilution (thousands) |
37,281 | 25,208 |
Exchange rate differences have been recognized in the income statement as follows:
| Group | Parent company | |||
|---|---|---|---|---|
| 2015 | 2014 | 2015 | 2014 | |
| Other operating income (note 7) | – | 2 423 | – | 2 423 |
| Other operating expenses | -658 | – | -658 | – |
| Total exchange rate differences in income statement |
-658 | 2 423 | -658 | 2 423 |
| Group | |||
|---|---|---|---|
| Balanserade utgifter för utvecklingsarbeten | 31-12-2015 | 31-12-2014 | |
| Ingoing accumulated acquisitionvalue | 22,551 | 20,723 | |
| Capitalized expenses | 355 | 1,828 | |
| Outgoing accumulated acquisitionvalue | 22,906 | 22,551 | |
| Ingoing accumulated depreciaton | – | – | |
| Depreciation | -2,083 | – | |
| Outgoing accumulated depreciation | -2,083 | – | |
| Closing balance | 20,823 | 22,551 |
Impairment testing has been carried out for the above carrying amounts as they relate to intangible assets that are not yet ready for use, with the conclusion that an impairment requirement does not exist. The impairment testing comprises the recoverable amount of the cash-generating unit's estimated value in use.
Depreciation expenses of KSEK 2 083 (KSEK 0) are included in their entirety among administrative expenses.
| Group | Parent company | |||
|---|---|---|---|---|
| Tangible assets | 31-12-2015 | 31-12-2014 | 31-12-2015 | 31-12-2014 |
| Ingoing accumulated | ||||
| acquisitionvalue | 12,742 | 8,103 | 12,742 | 8,006 |
| Investments | 984 | 5,419 | 984 | 5,419 |
| Sales and disposals | 0 | -780 | 0 | -683 |
| Outgoing accumulated acquisitionvalue |
13,726 | 12,742 | 13,726 | 12,742 |
| Ingoing accumulated depreciaton | -5,623 | -4,927 | -5,623 | -4,875 |
| Sales and disposals | 0 | 733 | 0 | 655 |
| Depreciation | -1,469 | -1,429 | -1,469 | -1,403 |
| Outgoing accumulated | ||||
| depreciation | -7,092 | -5,623 | -7,092 | -5,623 |
| Closing balance | 6,634 | 7,119 | 6,634 | 7,119 |
Depreciation expenses of KSEK 1 469 (KSEK 1 429) are included in their entirety among administrative expenses.
| Group | Parent company | |||
|---|---|---|---|---|
| Deferred tax assets | 31-12-2015 | 31-12-2014 | 31-12-2015 | 31-12-2014 |
| Deferred tax assets to be used after 12 months |
44,391 | 238 | 44,391 | 238 |
| Deferred tax assets to be used within 12 months |
– | – | – | – |
| Total deferred tax assets | 44,391 | 238 | 44,391 | 238 |
| Deferred tax liabilities | ||||
| Deferred tax liabilities to be used after 12 months |
-4,616 | -8,317 | – | – |
| Deferred tax liabilities to be used within 12 months |
-458 | -458 | – | – |
| Total deferred tax liabilities | -5,074 | -8,775 | – | – |
| Deferred tax liabilities/assets (net) | 39,317 | -8,537 | 44,391 | 238 |
| Group | Parent company | |||
|---|---|---|---|---|
| Gross change regarding deferred taxes | 2015 | 2014 | 2015 | 2014 |
| Opening balance | -8,537 | -4,577 | 238 | 199 |
| Redovisning i eget kapital | 3,127 | – | 3,127 | – |
| Recognition in income statement (note 10) | 44,727 | -3,960 | 41,026 | 39 |
| Closing balance | 39,317 | -8,537 | 44,391 | 238 |
Details of changes in deferred tax assets and tax liabilities during the year that have not been recognized in the income statement, excluding offsetting that has been carried out within the same tax jurisdiction, are given below:
| Untaxed reserves |
Intangible assets |
Total | ||
|---|---|---|---|---|
| -217 | -4,559 | -4,776 | ||
| -3,597 | -402 | -3,999 | ||
| -3,814, | -4,961 | -8,775 | ||
| -3,814 | -4,961 | -8,775 | ||
| 3,321 | 380 | 3,701 | ||
| -493 | -4,581 | -5,074 | ||
| Group |
| Group/Parent company | |||||
|---|---|---|---|---|---|
| Deferred tax assets | Loss carry-forward |
Reserved pension costs |
Accrued revenue |
Total | |
| On 1 January, 2014 | – | 199 | – | 199 | |
| Recognized in income statement | – | 39 | – | 39 | |
| On 31 December, 2014 | – | 238 | – | 238 | |
| On 1 January, 2015 | – | 238 | – | 238 | |
| Recognized in income statement | 44,135 | 18 | – | 44,153 | |
| On 31 December, 2015 | 44,135 | 256 | – | 44,391 |
There is no capitalized loss carry-forwards in the Group. The amount above is preliminary, not yet recognized loss carry-forwards.
| Parent company | |
|---|---|
| On 1 January, 2014 | 673 |
| Group contributions paid Bioimplant Scandinavia AB | 1 697 |
| Impairments | -1 697 |
| Disposals | -100 |
| On 31 December, 2014 | 573 |
| On 1 January, 2015 | 573 |
| Other transactions | 0 |
| On 31 December, 2015 | 573 |
On 31 December 2014, the shares in Bioimplant Scandinavia AB (556372-5885) were sold to the parent company Sandberg Development AB.
The Parent company has shares in the following subsidiaries:
| Country of registration |
Share of | Number of | Booked value | |||
|---|---|---|---|---|---|---|
| Name | Org.number | and operation | equity | shares | 31-12-2015 | 31-12-2014 |
| Camurus Inc | 43-1648843 | USA | 100% | 1 000 | 83 | 83 |
| Cubosome Inc | 43-1648841 | USA | 100% | 1 000 | 83 | 83 |
| Camurus Development AB |
556421-1208 | Sweden | 100% | 3,591,143 | 407 | 407 |
| Total | 573 | 573 |
The share of voting rights corresponds to the share of equity.
| Group | ||
|---|---|---|
| Balance sheet assets | 31-12-2015 | 31-12-2014 |
| Loans and receivables | ||
| Trade receivables | 8,917 | 6,118 |
| Other receivables | 207 | 157,908 |
| Cash and cash equivalents | 716,096 | 56 |
| Total | 725,220 | 164,082 |
| Balance sheet liabilities | ||
| Other liabilities | ||
| Liabilities to Group companies | – | 1,697 |
| Trade payables | 31,641 | 9,938 |
| Other liabilities | 191 | 191 |
| Total | 31,832 | 11,826 |
| Group | Parent company | ||||
|---|---|---|---|---|---|
| 31-12-2015 | 31-12-2014 | 31-12-2015 | 31-12-2014 | ||
| Trade receivables | 8,917 | 6,118 | 8,917 | 6,118 | |
| Deduction: Provision for bad debts | -68 | – | -68 | – | |
| Trade receivables – net | 8,849 | 6,118 | 8,849 | 6,118 |
Sound receivables on 31 December 2015, totaled KSEK 1 109 (KSEK 1 551) overdue trade receivables but without any impairment requirement deemed to exist for the Group. The overdue receivables relate to a number of customers who have not previously had any payment difficulties.
| Group | Parent company | ||||
|---|---|---|---|---|---|
| Their aging analysis is as follows | 31-12-2015 | 31-12-2014 | 31-12-2015 | 31-12-2014 | |
| 1-30 days | 58 | 1,482 | 58 | 1,482 | |
| 31-60 days | – | – | – | – | |
| > 61 days | 1,051 | 69 | 1,051 | 69 | |
| Summa förfallna kundfordringar | 1,109 | 1,551 | 1,109 | 1,551 |
| 31-12-2015 | 31-12-2014 | |
|---|---|---|
| Cash pool | – | 157,986 |
| Other settlement | 207 | 100 |
| Accrued expenses | – | -178 |
| Total | 207 | 157,908 |
The summary gives details of the transactions that the parent company Camurus AB has with principal shareholder Sandberg Development AB.
| Reported amount, by currency, for trade receivables are as follows |
Group | Parent company | |||
|---|---|---|---|---|---|
| 31-12-2015 | 31-12-2014 | 31-12-2015 | 31-12-2014 | ||
| SEK | 275 | 8 | 275 | 8 | |
| EUR | 2,190 | 779 | 2,190 | 779 | |
| USD | 6,311 | 5,296 | 6,311 | 5,296 | |
| Other currencies | 141 | 35 | 141 | 35 | |
| Total trade receivables | 8,917 | 6,118 | 8,917 | 6,118 |
| Group | Parent company | ||||
|---|---|---|---|---|---|
| 31-12-2015 | 31-12-2014 | 31-12-2015 | 31-12-2014 | ||
| Prepayments | 3,141 | 2,105 | 3,141 | 2,105 | |
| Accrued income relating to unbilled costs |
11,132 | 7,796 | 11,132 | 7,796 | |
| Accrued income, other | 1,340 | 1,024 | 1,340 | 1,024 | |
| Total | 15,613 | 10,925 | 15,613 | 10,925 |
| The following is included in cash | Group | Parent company | |||
|---|---|---|---|---|---|
| and cash equivalents in the balance sheet and cash flow statement |
31-12-2015 | 31-12-2014 | 31-12-2015 | 31-12-2014 | |
| Cash and bank deposits | 716,094 | 54 | 716,094 | 54 | |
| Petty cash | 2 | 2 | 2 | 2 | |
| Total | 716,096 | 56 | 716,096 | 56 |
| Number of shares |
Share capital |
Other contributed |
Total | |
|---|---|---|---|---|
| On 1 January, 2014 | 23,341 | 583 | 33,617 | 34,200 |
| Exercise of warrants/new shares | 1,867 | 47 | 25,017 | 25,064 |
| On 31 December, 2014 | 25,2081) | 630 | 58,634 | 59,264 |
| On 1 January, 2015 | 25,208 | 630 | 58,634 | 59,264 |
| Ongoing share bonus program for personnel and Board members |
1,909 | 47 | 47 | |
| Directed share issue to the principal | ||||
| owner | 427 | 11 | 23,879 | 23,890 |
| Direct share issue, public listing | 9,737 | 244 | 554,756 | 555,000 |
| Issuance costs, net after deferred tax | -11,088 | -11,088 | ||
| On 31 December, 2015 | 37,281 | 932 | 626,181 | 627,113 |
1) At an extraordinary general meeting October 7, 2015, a share split of 4: 1 was resolved. The number of shares has thereby been restated retroactively in the statement.
Share capital consists of 37 281 486 shares with a quota value of SEK 0,025. The shares carry a voting right of one (1) vote per share. All shares issued by the parent company are fully paid up.
On 9 December 2014, 1 867 320 (after split 4:1) outstanding warrants were exercised, corresponding to 1 867 320 (after split 4:1) new shares and an increase in the share capital of SEK 46,683. The subscription price was SEK 53.69 (before the split 4:1) per new share, corresponding to a total of SEK 25,064,103, of which SEK 25,017,420 has been transferred to other contributed capital. The new shares were registered on 9 January, 2015.
Until December 3, 2015, the group had a share-based compensation plan aimed at employees and board members at Camurus, in which the right to receive shares in relation to bonus issued began with a public listing of Camurus' shares. The shares were received in exchange of payment of the share's quota value of 0,025 Swedish krona, i.e. essentially free of charge. Bonus payments would amount to 5-10 percent of enterprise value in a market listing of Camurus shares. The Bonus programs were conditional on that the employee was employed in Camurus at market listing.
Up until 12 June 2015, when the bonus program was modified, the share bonus program was a cash bonus program in which settlement would be made in cash. Up until the point the program was modified, Camurus did not consider it likely that an exit event would occur, which is why no cost or liability regarding the bonus program was recognized from previously. At each balance sheet date, Camurus assessed the likelihood of service and performance conditions being fulfilled. On 30 June, 2015, Camurus deemed for the first time that an exit event through a public listing was likely. Since the bonus program was allocated to the employees in a previous accounting period, and was therefore already vested to a certain extent, earnings on 30 June 2015 were charged with a retroactive cost in 2015.
On December 3, 2015 Camurus' shares were listed on the stock exchange. This lead to that the terms of the share bonus program had been fulfilled and the employees and board members who were employed at that point in time were entitled to an allocation of shares in accordance with the bonus agreement. A total of 1,909,483 shares were allocated. The total impact on earnings amounted to MSEK 108.9 after tax, with a corresponding increase in equity of MSEK 108.8 and a social security cost of MSEK 30.8. The terms of the share bonus program have now been met in full and no additional costs will be charged against Camurus' earnings under this program.
The fair value of the bonus program is based on its enterprise value when Camurus' shares were listed on the stock exchange. The share price on the redemption date for the share bonus program was SEK 57.
Camurus had, on the 31st of December 2014, a cash-settled share-based bonus program aimed at specific employees and all Board members (apart from Per Sandberg) at Camurus, in which the right to receive a bonus in relation to bonus shares issued began with an exit event, which meant a transfer of more than 90 percent of all shares in Camurus or a public listing of Camurus' shares within the period prescribed in the program. The bonus amount amounted to a certain percentage of the agreed purchase price on transfer of the shares in Camurus, or the equivalent percentage of the enterprise value on a public listing of Camurus' shares. The cash bonus program was classified in accordance with IFRS 2 Share-based Payment as a cash-settled share-based payment, where Camurus received services from its employees by undertaking a commitment to transfer cash to the employees in exchange for an amount based on the price or value of Camurus' Shares. The fair value of the cash bonus program was expensed with a corresponding increase in liabilities. At each balance sheet date, Camurus assessed the likelihood of service and performance conditions being fulfilled. During the reporting period, Camurus concluded that it was not likely that an exit event would occur within the period prescribed in the program and therefore no cost or liability regarding the cash bonus program was recognized as of 31 December 2014.
| Group | Parent company | |||
|---|---|---|---|---|
| 31-12-2015 | 31-12-2014 | 31-12-2015 | 31-12-2014 | |
| Accrued holiday pay and other items | 6,761 | 6,887 | 6,761 | 6,887 |
| Accrued social security contributions |
5,645 | 5,000 | 5,645 | 5,000 |
| Accrued expenses relating to clinical studies |
3,250 | 14,143 | 3,250 | 14,143 |
| Accrued expenses, other | 3,927 | 894 | 3,927 | 894 |
| Accrued license fees | 26,371 | 26,228 | 26,371 | 26,228 |
| Total | 45,954 | 53,152 | 45,954 | 53,152 |
The Group only has operating leases relating to premises, cars and machinery.
Future minimum lease payments in accordance with non-cancellable operating leases valid at the end of the reporting period are due for payment as follows
| Group | Parent company | ||||
|---|---|---|---|---|---|
| 31-12-2015 | 31-12-2014 | 31-12-2015 | 31-12-2014 | ||
| 0–1 year | 7,235 | 5,407 | 7,235 | 5,407 | |
| 1–5 years | 11,603 | 13,224 | 11,603 | 13,224 | |
| > 5 years | – | – | – | – | |
| Koncernen totalt | 18,838 | 18,631 | 18,838 | 18,631 |
Costs for operating leases in the Group during the financial year have amounted to KSEK 6 164 (KSEK 5 279).
| Group | Parent company | ||||
|---|---|---|---|---|---|
| 31-12-2015 | 31-12-2014 | 31-12-2015 | 31-12-2014 | ||
| Depreciation | 3,552 | 1,427 | 1,469 | 1,403 | |
| Other | 108,793 | – | 108,793 | – | |
| Total | 112,345 | 1,427 | 110,262 | 1,403 |
Sandberg Development AB owns 53,7 percent of the shares in Camurus AB and therefore has a controlling interest in the Group. Sandberg Development AB is in turn 100-percent owned by PGS Group AB, which is in turn 100-percent owned by Per Sandberg. Other related parties are all subsidiaries in the Group, along with key management personnel in the Group, i.e. the Board and company management, as well as their family members.
| (a) Purchase and sales of services | 2015 | 2014 |
|---|---|---|
| Purchase of services | ||
| Parent company (primarily IT and administrative services) | 1,504 | 2,789 |
| Total | 1,504 | 2,789 |
| Sales of services | ||
| Parent company (primarily IT and rents) | 165 | – |
| Total | 165 | – |
Goods and services are purchased and sold on normal commercial terms. Transactions with Sandberg Development AB occur regarding IT and HR support services supplied. Pricing is done in accordance with allocation of costs in relation to utilization rate and on commercial terms.
| (b) Remuneration for executive management | 2015 | 2014 |
|---|---|---|
| Salaries and other short-term benefits | 11,842 | 6,539 |
| Termination benefits | – | – |
| Post-employment benefits | – | – |
| Other long-term benefits | 2,365 | 1,583 |
| Share-based payment | 36,064 | – |
| Total | 50,271 | 8,122 |
Remunerations are paid to the Chairman of the Board, Board members and for committee work in accordance with decisions made by the AGM.
The extraordinary general meeting on October 7, 2015, resolved on guidelines for remuneration and conditions for senior executives. Remuneration to the CEO and other senior executives comprises basic salary, variable remuneration, pension benefits, other benefits and terms of notice. Other senior executives includes those individuals who together with the CEO from Group management. For the current composition of Group management, see pages 78-79.
The division between basic salary and variable remuneration is to be linked to the executive's level of responsibility and authority. The variable remuneration is to be based on the outcome of predetermined well-defined objectives. The variable cash remuneration is to be limited to thirty (30) percent of the fixed annual salary. Variable remuneration may also be paid in the form of long-term incentive programs.
| Board fee3) | Audit committee3) |
Remu neration committee3) |
Sharebonus program 20152) |
Total |
|---|---|---|---|---|
| 19 | – | 3,005 | 3,292 | |
| 128 | 19 | – | 3,005 | 3,152 |
| 19 | – | 3,005 | 3,152 | |
| 56 | 19 | – | 3,005 | 3,080 |
| – | – | – | – | 0 |
| 128 | – | – | 3,005 | 3,133 |
| 56 | – | – | – | 56 |
| – | – | 601 | 713 | |
| 112 | – | – | 601 | 713 |
| 988 | 76 | 0 | 16,227 | 17,291 |
| 2681) 1281) 1121) Marianne Dicander Alexandersson |
Finalized |
| Basic salary |
Variable remu neration |
Other benefits |
Pension expenses |
Finalized Sharebonus program 20152) |
Total |
|---|---|---|---|---|---|
| 1,860 | 700 | 75 | 731 | 9,016 | 12,382 |
| 7,747 | 1,127 | 333 | 1,634 | 27,048 | 37,889 |
| 9,607 | 1,827 | 408 | 2,365 | 36,064 | 50,271 |
For one of the senior executives, in order to attract staff with key skills, deviations against the above guidelines have been made during the year. These deviations means that the agreed conditions provide the opportunity to receive variable compensation of a maximum of 45 percent of the fixed basic salary, and that a compensation of MSEK 2.2 was paid in connection with the signing of the employment contract with the senior executive. This amount, net after withheld tax, have been used in full to subscribe for shares in Camurus. Also as deviation from the guidelines established at the EGM in October 2015, the Board has in order to provide the CEO with market-based conditions resolved to allow variable cash remuneration of a maximum of 40 percent. The resolution shall enter into force January 1st, 2016. Without constituting a deviation, it is hereby also informed of that the variable remuneration, for the year of 2015, to the CEO was resolved before the adoption of the new guidelines at the EGM, October 7th, 2015. Thus the results of the variable remuneration in 2015 of about 38 percent of the annual
| Basic salary/ | Variable remu |
Other | Pension | Other remu |
||
|---|---|---|---|---|---|---|
| Board fee | neration | benefits | expenses | neration | Total | |
| Board of Directors | ||||||
| Björn Olsson, chair. | 170 | – | – | – | – | 170 |
| Per-Olof Wallström | 601) | – | – | – | – | 60 |
| Svein Mathisen | 60 | – | – | – | – | 60 |
| Martin Jonsson | – | – | – | – | – | – |
| Fredrik Tiberg | – | – | – | – | – | – |
| Per-Anders | ||||||
| Abrahamsson | 601) | – | – | – | – | 60 |
| Per Sandberg | – | – | – | – | – | – |
| Group management | ||||||
| Fredrik Tiberg, CEO | 1,754 | 800 | 76 | 646 | – | 3,276 |
| Other executive management |
||||||
| (4 individuals) | 2,790 | 932 | 187 | 937 | – | 4,846 |
| Total | 4,894 | 1,732 | 263 | 1,583 | – | 8,472 |
1) Remuneration invoiced via company
2) Regarding Share based payment see note 24.
3) Fees, proportionally accounted, for payment twice a year, adopted by the general meeting,
No board remuneration for CEO is paid.
salary, exceeded they later adopted guidelines with a ceiling on variable remuneration of 30 percent. The variable remuneration is based on the outcome of the activities previously agreed and approved by the Board objectives. Other benefits to the CEO and other senior executives are part of the total compensation. With pension costs means costs of pension payable under the agreement.
On 7 December 2010, at the company's AGM, 1 867 320 (after dilution 4:1) warrants were issued with a right to subscribe to the equivalent number of shares in the Company during the period 1 December 2014 – 31 December 2014.
The warrants were subscribed by the CEO at a subscription price corresponding to the fair value of the warrants, which is why no cost is recognized in the income statement regarding this program. The subscription price was recognized as other contributed capital. In December 2014, the CEO sold 420 000 (after split 4:1) warrants to Sandberg Development AB and exercised the other 1 447 320 (after split 4:1) warrants for subscription of the equivalent number of shares in the Company at a subscription price of SEK 53,69 per share (before split 4:1) (according to terms of issue). Sandberg Development AB exercised 420 000 (after split 4:1) warrants for subscription of the equivalent number of shares in the Company at a subscription price of SEK 53,69 per share. (before split 4:1).
See note 24 Share-based Payment.
The pensionable age for the Chief Executive Officer and key management personnel is 65 years.
The notice period between the Company and CEO is 12 months from the Company, and 6 months from the CEO. If the CEO's employment at the Company ceases as a result of, or in connection with the Company being transferred to a new owner, a notice period of 24 months from the Company applies. During the notice period a fixed monthly salary is paid, along with other remuneration in accordance with the applicable employment agreement. Remuneration from the Company will not in this case be reduced by any other possible remuneration that the CEO may receive during the notice period. No severance pay is payable in the event of notice being given by the CEO.
A mutual notice period of 3–6 months applies between the company and other key management personnel.
| Receivables from related parties | 31-12-2015 | 31-12-2014 |
|---|---|---|
| Bioimplant AB | 75 | – |
| Sandberg Development AB | 132 | 157,908 |
| Total | 207 | 157,908 |
Receivables from related parties are essentially derived from a joint cash pool plus Group contributions paid/received. The Group has not made any provisions for bad debts from related parties.
| Liabilities to related parties | 31-12-2015 | 31-12-2014 |
|---|---|---|
| Bioimplant Scandinavia AB | – | 1,697 |
| Total | – | 1,697 |
The liability as per 31 December 2014, concerns shareholder contributions to Bioimplant Scandinavia AB.
(d) Acquisition and sales of shares in Bioimplant Scandinavia AB Se not 17 Andelar i koncernföretag.
Not 29 Items affecting comparability
Until and including the third quarter, earnings were charged with MSEK 10.9 relating to costs for preparations of a possible public listing of the company's shares. In connection with the completion of the listing on December 3, 2015, these expenses were reclassified from administrative expenses to items affecting comparability. In the fourth quarter, earnings were charged with an additional MSEK 23.1 and the total expense of MSEK 34.0 (0) was reported under items affecting comparability.
Since June 2013, Camurus had a long-term share-based bonus program aimed at employees and Board members at Camurus, in which the right to receive shares in relation to bonus
shares issued began with a public listing of Camurus' shares. The shares were to be received in exchange for payment of the share's quota value, i.e. essentially free of charge. Should an exit event have occurred involving the transfer of more than 90 percent of all shares in Camurus, employees and Board members would have been entitled to receive cash.
Up until 12 June 2015, when the bonus program was modified, the share bonus program was a cash bonus program in which settlement would be made in cash. Up until the point the program was modified, Camurus did not consider it likely that an exit event would occur, which is why no cost or liability regarding the bonus program was recognized from previously.
At each balance sheet date, Camurus has assessed the likelihood of service and performance conditions being fulfilled. On 30 June, 2015, Camurus deemed for the first time that an exit event through a public listing was likely. Since the bonus program was allocated to the employees in a previous accounting period, and was therefore already vested to a certain extent, earnings on 30 June 2015 were charged with a retroactive cost of MSEK 116.0, including social security contributions before tax, with a corresponding increase in equity of MSEK 88.3 and a social security liability of MSEK 27.7. Since then, the probability of the service and performance conditions being fulfilled has been assessed continuously until December 3, 2015 when Camurus' shares were listed on the stock exchange. The terms of the share bonus program had been fulfilled and the employees and board members who were employed at that point in time were entitled to an allocation of shares in accordance with the bonus agreement. A total of 1,909,483 shares were allocated. The total impact on earnings amounted to MSEK 108.9 after tax, with a corresponding increase in equity of MSEK 108.8 and a social security cost of MSEK 30.8. The fair value of the bonus program is based on its enterprise value when Camurus' shares were listed on the stock exchange. The share price on the redemption date for the share bonus program was SEK 57. The terms of the share bonus program have now been met in full and no additional costs will be charged against Camurus' earnings under this program. Social contribution fee and withheld tax for the participants in the share bonus program amounted to MSEK 86.6 and has been paid in January 2016.
In order to compensate for the social security costs arising net after tax, the company and principal shareholder Sandberg Development AB entered into an agreement (conditional upon a public listing), in accordance with which the principal shareholder undertook to subscribe to newly issued shares in Camurus at total issue proceeds corresponding to 78 percent of these costs, calculated based on the median of the price range in the offering, SEK 56, submitted in connection with the public listing. In connection with the listing on December 3, 2015, the principal shareholder fulfilled its commitment and subscribed for 426,601 shares for a payment of MSEK 23.9.
Since the total cost in connection with the listing and the share bonus program is of an unusual nature and non-recurring, and significant in terms of the amount, the item will be recognized as an item affecting comparability in this and future financial reports.
Following below is the consolidated income statement as it would have looked had the listing expenses and the cost of the share bonus program not been separated out.
| Financial year | |||
|---|---|---|---|
| KSEK | Note | 31-12-2015 | 31-12-2014 |
| Revenues | 5 | 154,799 | 208,207 |
| Cost of goods sold | 6 | -237 | -656 |
| Gross profit | 154,562 | 207,551 | |
| Operating costs | |||
| Marketing and distribution costs | 6 | -31,338 | -11,402 |
| Administrative expenses | 6, 8 | -74,790 | -22,165 |
| Research and development costs | 6 | -251,937 | -114,146 |
| Other operating income | 7, 13 | 57 | 2,481 |
| Other operating expenses | 13 | -658 | – |
| Operating result before items affecting comparability | -204,104 | 62,319 | |
| Result from financial items | |||
| Finance income | 10 | 2 | 394 |
| Finance expenses | 10 | -166 | -170 |
| Net financial items | -164 | 224 | |
| Result before tax | -204,268 | 62,543 | |
| Income tax | 11 | 44,727 | -14,197 |
| Result for the period | -159,542 | 48,346 |
On January 4, 2016, a license agreement was signed with Rhythm Pharmaceuticals regarding the CAM4072 product for the treatment of genetic obesity. The agreement had no impact on revenues and earnings in 2015.
The Board of Directors and CEO affirm that the consolidated financial statements have been prepared in accordance with international financial reporting standards IFRS, as adopted by the EU, and provide a fair and accurate account of the Group's financial position and earnings.
This Annual Report was prepared in accordance with generally accepted accounting policies and provides a fair and accurate account of the Parent Company's financial position and earnings. The Administration Report for the Group and Parent Company provides a fair and accurate overview of the performance of the Parent Company and the Group's operations, financial position and earnings and describes the material risks and uncertainties faced by the Parent Company and the companies belonging to the Group.
The income statements and balance sheets will be presented for approval to the Annual General Meeting on 3 May 2016.
Chairman of the Board Board member Board member
Per-Olof Wallström Björn Olsson Per-Anders Abrahamsson
Per Sandberg Martin Jonsson Marianne Dicander Alexandersson Board member Board member Board member
Svein Mathiesen Kerstin Valinder Strinnholm Fredrik Tiberg Board member Board member CEO, Board member
Our Audit Report was submitted on 30 March 2016
Mazars SET Revisionsbyrå AB PricewaterhouseCoopers AB Gunilla Malmsten Ola Bjärehäll Authorised Public Accountant Authorised Public Accountant
Auditor in Charge Auditor in Charge
We have audited the annual accounts and consolidated accounts of Camurus AB for the year 2015, except for the corporate governance statement on pages 38-44. The annual accounts and consolidated accounts of the company are included in the printed version of this document on pages 33-75
The Board of Directors and the Managing Director are responsible for the preparation and fair presentation of these annual accounts in accordance with the Annual Accounts Act and of the consolidated accounts in accordance with International Financial Reporting Standards , as adopted by the EU, and the Annual Accounts Act, and for such internal control as the Board of Directors and the Managing Director determine is necessary to enable the preparation of annual accounts and consolidated accounts that are free from material misstatement, whether due to fraud or error.
Our responsibility is to express an opinion on these annual accounts and consolidated accounts based on our audit. We conducted our audit in accordance with International Standards on Auditing and generally accepted auditing standards in Sweden. Those standards require that we comply with ethical requirements and plan and perform the audit to obtain reasonable assurance about whether the annual accounts and consolidated accounts are free from material misstatement.
An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the annual accounts and consolidated accounts. The procedures selected depend on the auditor's judgement, including the assessment of the risks of material misstatement of the annual accounts and consolidated accounts, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the company's preparation and fair presentation of the annual accounts and consolidated accounts 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 company's internal control. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of accounting estimates made by the Board of Directors and the Managing Director, as well as evaluating the overall presentation of the annual accounts and consolidated accounts.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinions.
In our opinion, the annual accounts have been prepared in accordance with the Annual Accounts Act and present fairly, in all material respects, the financial position of the parent company as of 31 December 2015 and of its financial performance and its cash flows for the year then ended in accordance with the Annual Accounts Act. The consolidated accounts have been prepared in accordance with the Annual Accounts Act and present fairly, in all material respects, the financial position of the group as of 31 December 2015 and of their financial performance and cash flows for the year then ended in accordance with International Financial Reporting Standards, as adopted by the EU, and the Annual Accounts Act. Our opinions do not cover the corporate governance statement on pages 38-44. The statutory administration report is consistent with the other parts of the annual accounts and consolidated accounts.
We therefore recommend that the annual meeting of shareholders adopt the income statement and balance sheet for the parent company and the group.
In addition to our audit of the annual accounts and consolidated accounts, we have also audited the proposed appropriations of the company's profit or loss and the administration of the Board of Directors and the Managing Director of Camurus AB for the year 2015. We have also conducted a statutory examination of the corporate governance statement.
The Board of Directors is responsible for the proposal for appropriations of the company's profit or loss, and the Board of Directors and the Managing Director are responsible for administration under the Companies Act and that the corporate governance statement on page 38-44 has been prepared in accordance with the Annual Accounts Act.
Our responsibility is to express an opinion with reasonable assurance on the proposed appropriations of the company's profit or loss and on the administration based on our audit. We conducted the audit in accordance with generally accepted auditing standards in Sweden.
As a basis for our opinion on the Board of Directors' proposed appropriations of the company's profit or loss, we examined whether the proposal is in accordance with the Companies Act.
As a basis for our opinion concerning discharge from liability, in addition to our audit of the annual accounts and consolidated accounts, we examined significant decisions, actions taken and circumstances of the company in order to determine whether any member of the Board of Directors or the Managing Director is liable to the company. We also examined whether any member of the Board of Directors or the Managing Director has, in any other way, acted in contravention of the Companies Act, the Annual Accounts Act or the Articles of Association.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinions.
Furthermore, we have read the corporate governance statement and based on that reading and our knowledge of the company and the group we believe that we have a sufficient basis for our opinions. This means that our statutory examination of the corporate governance statement is different and substantially less in scope than an audit conducted in accordance with International Standards on Auditing and generally accepted auditing standards in Sweden.
We recommend to the annual meeting of shareholders that the profit be appropriated in accordance with the proposal in the statutory administration report and that the members of the Board of Directors and the Managing Director be discharged from liability for the financial year.
A corporate governance statement has been prepared, and its statutory content is consistent with the other parts of the annual accounts and consolidated accounts.
Mazars SET Revisionsbyrå AB PricewaterhouseCoopers AB Gunilla Malmsten Ola Bjärehäll Authorized Authorized Public Accountant Public Accountant
Per Olof Wallström Chairman of the Board since 2015 and Board member since 2010.
Education: M.Sc. in Pharmacy from Uppsala University.
Chairman of the Board of MB Erikssons Bygg & Fastighet AB and Patients Pending Ltd. Board member of Hansa Medical AB and Arosia Communication AB and Neo Dynamics AB. Deputy Board member of Reabyrån AB.
CEO of Q-Med, Melacure and Karo Bio AB. Senior management at Merck Sharpe & Dohme, AstraZeneca, Pharmacia and Bristol Myers Squibb.
Holdings: 52,748
Per-Anders Abrahamsson Board member since 2006.
Born: 1949.
Education: Doctor of Medicine from Lund University, Ph.D., associate professor and professor of urology.
Executive Medical Director of Ferring Pharmaceutical. Chief physician at Skånes universitetssjukhus. Board member of Medisport AB and GOAR Holding A/S.
Marianne Dicander Alexandersson
Board member since 2015.
Born: 1959.
Education: M.Sc. in Chemical Engineering from Chalmers University of Technology.
Other current appointments: Board member of Enzymatica AB (publ), Recipharm AB (publ) and West Atlantic. Chairman of the Board and CEO of MDA Management AB. Member of the council at Skandia. Chairman of Sahlgrenska Science Park and medlem member of the Advisory Council of the Dental and Pharmaceutical Benefits Agency.
Work Experience: CEO of Kronans Droghandel, Global Health Partner and Sjätte AP-fonden, deputy CEO of Apoteket AB. External CEO of GHP Specialty Care AB (publ) and Sjätte AP-fonden, external deputy CEO i Apoteket AB (publ). Leading positions in quality and market development at Pharmacia, Imperial Chemical Industries and Volvo.
Martin Jonsson Board member since 2013. Chairman of the Audit Committee and member of the Remuneration Committee.
Born: 1961.
Education: M.Sc. in Business Administration from Lund University.
CEO and Board member of Sandberg Development AB. Board member of Aimpoint AB, Granuldisk AB and Bioimplant Scandinavia AB.
Work Experience: Over 25 years of combined experience in corporate governance and working in senior positions in various industries such as medical devices, biotechnology and industrial kitchens.
Holdings: 22,682
Svein Mathisen Board member since 2010. Member of the Audit Committee and the Remuneration Committee.
Born: 1956.
Education: M.Sc. in engineering physics from the Norwegian University of Science and Technology.
Chairman of the Board of iCell Science AB and Gabather AB. Board member of Athera Biotechnologies AB, Genagon Therapeutics AB and Arild Capital AB.
Work Experience: CEO of BioInvent International AB. More than 25 years of experience in various senior positions in the Norsk Hydro Group.
Holdings: 41,143
Holdings: 10,550
Björn Olsson Board member since 2010. Member of the Audit Committee.
Born: 1945.
Education: M.Sc. in Business Administration specializing in Accounting and Finance from Lund University.
Chairman of the Board of Aimpoint AB, Aimpoint Inc. and Granuldisk AB. Board member of Sandberg Development AB, Davinci Roofspace LLC and Lead Independent Director of Saia Inc.
Work Experience: CEO of Harmon Industries Inc. Many years of experience in senior management and board work in Sweden and the US.
Holdings: 52,748
Per Sandberg Board member since 2006.
Born: 1962.
Education: M.Sc. in Mechanical Engineering from Lund Institute of Technology.
Chairman of the Board of Sandberg Development AB and Aimpoint Sweden AB. Board member of Ögårdsros AB, ANORK AB, Lesurak AB, PGS Group AB, Aimpoint AB, Granuldisk AB and Fosieby Företagsgrupp Ekonomisk Förening.
Work Experience: Partner in E & G Sandberg Handelsbolag. Former CEO of Granuldisk, Aimpoint AB and Sandberg Development AB.
Holdings: 20,014,978 thru Sandberg Development AB.
Fredrik Tiberg Board member, President and CEO since 2003.
Born: 1963.
Education: M.Sc. in Chemical Engineering from Lund Institute of Technology. Ph.D. in physical chemistry and associate professor of physical chemistry (surface chemistry) from Lund University.
Other current appointments: Adjunct professor of surface chemistry at Lund University. Board member of Medicon Valley Alliance, Bioimplant Scandinavia AB and Camurus Lipid Research Foundation.
Work Experience: CEO of Heptahelix AB, research director at Camurus, visiting professor of physical and theoretical chemistry at the University of Oxford.
Holdings: 1,512,551
Kerstin Valinder Strinnholm Board member since 2015.
Born: 1960.
Education: Degree from the School of Journalism at the University of Gothenburg.
Other current appointments: Board member of Corline Biomedical AB, KVS Invest AB and Cavastor AB.
Work Experience: EVP Business Development for the Nycomed Group. Many years of experience in sales, marketing and business development from senior positions at Astra/Astra-Zeneca and Nycomed/Takeda.
Holdings: 5,908
Gunilla Malmsten Authorised Public Accountant Mazars SET Revisionsbyrå AB
Ola Bjärehäll Authorised Public Accountant PricewaterhouseCoopers AB
Fredrik Tiberg CEO, President and Board member since 2003. Employee of the company since 2002.
Education: M.Sc. in Chemical Engineering from Lund Institute of Technology. Ph.D. in physical chemistry and associate professor of physical chemistry (surface chemistry) from Lund University.
Adjunct professor of surface chemistry at Lund University. Board member of Medicon Valley Alliance, Bioimplant Scandinavia AB and Camurus Lipid Research Foundation.
Heptahelix AB, research director at Camurus, visiting professor of physical and theoretical chemistry at the University of Oxford.
Holdings: 1,512,551
Fredrik Joabsson Vice President, Business Development and Alliance Management since 2011. Employee of the company since since 2001.
Education: Ph.D. in physical chemistry and M.Sc. in chemistry from Lund University.
Work Experience: Many years of experience in drug discovery through various positions in research and development and business development at Camurus.
Holdings: 36,391
Markus Johnsson Vice President, Pharmaceutical and Analytical Development since 2009. Employee of the company since since 2004.
Education: Ph.D. in physical chemistry and M.Sc. in chemistry from Uppsala University.
Work Experience: Postdoctoral researcher at the University of Groningen. Senior Scientist at Uppsala University. Senior Research Scientist and Manager for Parenteral Drug Delivery Systems at Camurus.
Holdings: 45,363
Margareta Linden Vice President, Project Management and Planning since 2004.
Education: B.Sc. in chemistry and biology and Ph.D. in zoophysiology from Lund University. Associate professor of experimental pulmonary medicine at Lund University.
Work Experience: Many years of experience from various positions within preclinical and clinical research and development in the pharmaceutical industry (Draco, AstraZeneca).
Holdings: 36,291
Torsten Malmström Vice President, Technical Operations since 2013.
Born: 1968.
Education: Ph.D. in chemistry from Lund University.
Work Experience: Director Pharmaceutical Development for Zealand Pharma and Director of Development for Polypeptide. Team Manager at AstraZeneca.
Holdings: 36,291
78 Camurus annual report 2015 Camurus annual report 2015 79
Rein Piir Vice President, Investor Relations since 2015, consultant.
Education: M.Sc. in Business Administration from Uppsala University.
Chairman of the Board and CEO of Piir & Partner AB. Board member of Integrative Research Laboratories Sweden AB, Trygga Pengar i Mobilen Sverige AB and L. E. Svensson Snickeri AB.
Work Experience: CFO/Head of Investor Relations at Medivir AB and auditor at Pricewaterhouse-Coopers AB. Many years of experience advising listed companies, including as head of research at Carnegie Investment Bank AB and strategist at Alecta.
Holdings: 5,275
Eva Pinotti-Lindqvist Chief Financial Officer since 2014.
Education: M.Sc. in Business Administration from Lund University.
Born: 1963.
Work Experience: CFO and Vice President Business Development of EQL Pharma AB. Market analyst for Nordic Drugs AB and financial consultant for Poolia AB. Controller of Svedala Svenska AB and Finance Manager for Poseidon Yacht Charter AB.
Holdings: 36,291
Agneta Svedberg Vice President, Clinical and Regulatory Development since 2015.
Born: 1963.
Education: M.Sc. in radiophysics and Executive MBA, Executive Foundation Lund (EFL), B.Sc. in Medicine, all from Lund University.
Work Experience: Many years of experience in drug development, including as COO of Zealand Pharma A/S, CEO of Cantargia AB and Senior Vice President, Clinical Development at Genmab A/S.
Holdings: 9,073
| Key figures, KSEK | 2015 | 2014 | 2013 | 2012 |
|---|---|---|---|---|
| Net revenues | 154,799 | 208,207 | 197,716 | 95,204 |
| Operating result before items affecting comparability | -30,464 | 62,319 | 127,316 | 18,761 |
| Operating result | -204,104 | 62,319 | 127,316 | 18,761 |
| Result for the period | -159,542 | 48,346 | 99,235 | 13,317 |
| Cash flow from operating activities | -5,657 | 69,429 | 163,064 | 24,735 |
| Cash and cash equivalents | 716,096 | 56 | 5 | 3 |
| Total assets | 816,349 | 207,668 | 111,656 | 57,405 |
| Average number of shares, before dilution | 25,208,560 | 23,458,908 | 23,341,240 | 23,341,240 |
| Average number of shares, after dilution | 26,497,361 | 25,208,560 | 25,208,560 | 25,208,560 |
| Earnings per share before dilution, SEK | -6.33 | 2.06 | 17.01 | 2.28 |
| Earnings per share after dilution, SEK | -6.33 | 1.92 | 15.75 | 2.11 |
| Equity per share before dilution, SEK | 25.41 | 19.59 | 8.58 | 6.89 |
| Equity per share after dilution, SEK | 17.18 | 19.59 | 7.94 | 6.38 |
| Number of employees at end of period | 48 | 43 | 36 | 31 |
| Number of employees in R&D at end of period | 35 | 28 | 29 | 25 |
| Equity, SEK thousand | 640 557 |
123 457 |
50 047 |
40 210 |
| Equity ratio in Group,percent | 78% | 59% | 45% | 70% |
| R&D costs as a percentage of operating expenses | 83% | 77% | 71% | 76% |
Cash and cash equivalents Cash and cash bank balances
Equity ratio, % Equity divided by total capital
Average number of shares, before dilution Average number of shares before adjustment for the dilution effect of new shares
Average number of shares, after dilution Average number of shares adjusted for the dilution effect of new shares
Earnings per share before dilution, SEK Result divided by the average number of shares outstanding before dilution
Earnings per share after dilution, SEK Result divided by the average number of shares outstanding after dilution
Equity per share before dilution Equity divided by the number of shares at the
end of the period before dilution
Equity divided by the number of shares at the end of the period after dilution
Research and development costs divided by operating expenses, excluding items affecting comparability (marketing and distribution costs, administrative expenses and research and development costs).
Camurus Annual General Meeting 2016 will be held on Tuesday 3 May 2016, at 17.00 CET, at Elite Hotel Ideon, Scheelevägen 27, Ideon Science Park, 223 63 Lund. Registration begins at 16.00 CET, when there will also by light refreshments served. Shareholders who wish to attend the meeting must be recorded in the share registered maintained by Euroclear Sweden AB (the Swedish Central Securities Depository) on April 27, 2016.
You must have notified the intention to attend the meeting no later than Wednesday, 27 April 2016 in one of the following ways:
Shareholders shall specify:
Shareholders who have registered their shares with a bank or another nominee trust must, to be entitled to participate in the General Meeting, register their shares in their own name so that the person concerned is recorded in the share registered maintained by Euroclear Sweden AB share register on April 27, 2016. Shareholders wishing to register their shares in their own name should inform the trust nominee well before this date. Such registration may be temporary.
Shareholders who intend to be represented by proxy must issue a written and dated power of attorney for the proxy. If the power of attorney is issued by a legal entity, a certified copy of a registration certificate or equivalent for the legal entity should be attached. The power of attorney is valid for one year from the issuance, or until the date of expiration shown on the power of attorney, but not later than five years.
The registration certificate shall evidence the circumstances prevailing at the date of the General Meeting and should not be older than one year on the date of the AGM. The original power of attorney and any registration certificate should be sent to the company by mail at the adress indicated above well in advance of the Meeting. A proxy form is available on the company's website www.camurus.com, and can also be sent to shareholders upon request.
Interim reports, annual reports and Camurus press releases are available on www.camurus.com and can be ordered from Camurus AB Ideon Science Park, 223 70 Lund, Sweden.
The Annual Report in printed form will be sent to all who had requested and it is always available for down load from: www.camurus.com.
May 3, 2016 Annual General Meeting May 17, 2016 Interim Report, January–March 2016 July 14, 2016 Interim Report, January–June 2016
Camurus AB Ideon Science Park 223 70 Lund
Visiting Address: Sölvegatan 41 A, Lund Telephone: +46 46-86 57 30 Fax: +46 46-286 57 39
Website: www.camurus.com Investor relation Contact: [email protected]
Camurus AB | Ideon Science Park, SE-223 70 Lund, Sweden Phone: +46 46 286 57 30 | Fax: +46 46 286 57 39 | E-mail: [email protected] | www.camurus.com
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