Annual Report • Apr 29, 2021
Annual Report
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FINANCIAL REPORT 2020
| 1. | GENERAL INFORMATION 7 | ||
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| 1.1 LANGUAGE OF THIS ANNUAL REPORT 7 | |||
| 1.2 STATUTORY AUDITOR 7 | |||
| 1.3 FORWARD-LOOKING STATEMENTS 7 | |||
| 1.4 MARKET AND INDUSTRY INFORMATION 7 | |||
| 1.5 OTHER AVAILABLE INFORMATION 7 | |||
| 1.6 AVAILABILITY OF THE ANNUAL REPORT 8 | |||
| 2. | ANNUAL REPORT OF THE BOARD OF DIRECTORS ON THE CONSOLIDATED FINANCIAL | ||
| STATEMENTS OF BONE THERAPEUTICS SA FOR THE FINANCIAL YEAR ENDING 31 DECEMBER | |||
| 2020 9 | |||
| 2.1. | LETTER TO SHAREHOLDERS 9 | ||
| 2.2. | BUSINESS OVERVIEW 12 | ||
| 2.3. | FINANCIAL AND STRATEGIC HIGHLIGHTS OF 2020 18 | ||
| 2.4. 2.5. |
FINANCIAL REVIEW OF THE YEAR ENDING 31 DECEMBER 2020 20 HEADCOUNT EVOLUTION 24 |
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| 2.6. | RISKS 24 | ||
| 2.7. | GOING CONCERN 25 | ||
| 2.8. | EVENTS OCCURRED AFTER THE END OF THE FINANCIAL YEAR 25 | ||
| 2.9. | OUTLOOK FOR THE REMAINDER OF 2021 26 | ||
| 3. | ORGANIZATIONAL STRUCTURE 27 | ||
| 3.1. | ORGANIGRAM 27 | ||
| 3.2. | INFORMATION ON HOLDINGS 27 | ||
| 4. | CORPORATE GOVERNANCE 28 | ||
| 4.1. | GENERAL 28 | ||
| 4.2. | COMPLIANCE WITH THE CORPORATE GOVERNANCE CODE 28 | ||
| 4.3. | BOARD OF DIRECTORS 29 | ||
| 4.3.1. | Composition of the Board of Directors 29 |
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| 4.3.2. 4.3.3. |
32 Activity Report Performance Evaluation of the Board |
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| 4.3.4. | 32 Committees within the Board of Directors 33 |
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| 4.4. | EXECUTIVE COMMITTEE 37 | ||
| 4.4.1. | General 37 |
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| 4.4.2. | Executive Committee 37 |
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| 4.4.3. | Operation 40 |
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| 4.5. | INTERNAL CONTROL AND RISK MANAGEMENT SYSTEMS 40 | ||
| 4.5.1. | Internal Mechanism 40 |
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| 4.5.2. | Risk Analysis 41 |
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| 4.5.3. | Financial Risk Management 44 |
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| 4.5.4. 4.6. |
Controls, Supervision and Correctives Actions 45 |
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| 4.7. | MARKET ABUSE REGULATIONS 45 REMUNERATION REPORT 46 |
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| 4.7.1. | Procedure 46 |
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| 4.7.2. | Remuneration Policy 46 |
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| 5. | RELATED PARTY TRANSACTIONS56 | ||
| 5.1. | GENERAL 56 | ||
| 5.2. | CONFLICTS OF INTEREST OF DIRECTORS 56 | ||
| 5.2.1. | Board of Directors of 11 February 2020 56 |
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| 5.2.2. | Board of Directors of 5 May 2020 57 |
| 5.2.3. | Board of Directors of 29 October 2020 59 |
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|---|---|---|---|
| 5.3. | EXISTING CONFLICTS OF INTEREST OF MEMBERS OF THE BOARD OF DIRECTORS AND OF THE EXECUTIVE | ||
| COMMITTEE AND RELATED PARTY TRANSACTIONS 60 | |||
| 5.4. | RELATED PARTY TRANSACTIONS 60 | ||
| 5.4.1. | Transactions with SCTS 60 |
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| 5.4.2. | Transactions with Bone Therapeutics USA Inc. 60 |
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| 5.4.3. | Transactions with the Walloon Region 60 |
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| 5.4.4. | Transactions with the Executive Committee 60 |
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| 5.5. | TRANSACTIONS WITH AFFILIATES 61 | ||
| 6. | SHARES AND SHAREHOLDERS62 | ||
| 6.1. | HISTORY OF CAPITAL—CAPITAL INCREASE AND ISSUANCE OF SHARES 62 | ||
| 6.1.1. | Securities Issued by the Company 62 |
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| 6.1.2. | History of Capital since IPO 62 |
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| 6.2. | AUTHORIZED CAPITAL 65 | ||
| 6.3. | CHANGES IN CAPITAL 66 | ||
| 6.3.1. | Changes to the Share Capital by the Shareholders of the Company 66 |
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| 6.3.2. | Capital Increases by the Board of Directors of the Company 66 |
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| 6.4. | WARRANT PLANS 67 | ||
| 6.4.1. | Warrant Plans Issued 67 |
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| 6.4.2. | Summary of the Outstanding Warrant Plans 68 |
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| 6.5. | ELEMENTS WHICH BY THEIR NATURE WOULD HAVE CONSEQUENCES IN CASE OF A PUBLIC TAKE-OVER BID ON THE | ||
| COMPANY 69 | |||
| 6.6. | TRANSPARENCY 70 | ||
| 6.7. | SHAREHOLDERS 70 | ||
| 6.8. 6.8.1. |
DIVIDENDS AND DIVIDEND POLICY 71 Entitlement to Dividends |
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| 6.8.2. | 71 Dividend Policy |
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| 71 | |||
| 7. | CONSOLIDATED FINANCIAL STATEMENTS72 | ||
| 7.1. | RESPONSIBILITY STATEMENT 72 | ||
| 7.2. | STATUTORY AUDITOR'S REPORT ON THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEAR ENDED 31 | ||
| DECEMBER 2020 73 | |||
| 7.3. | CONSOLIDATED FINANCIAL STATEMENTS AS OF 31 DECEMBER 2020 AND 2019 UNDER IFRS 80 | ||
| 7.3.1. | Consolidated Statement of Financial Position 80 |
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| 7.3.2. | Consolidated Statement of Comprehensive Income 81 |
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| 7.3.3. | Consolidated Statement of Cash Flow 82 |
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| 7.3.4. | Consolidated Statement of Changes in Equity 83 |
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| 8. | NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS84 | ||
| 8.1. | GENERAL INFORMATION 84 | ||
| 8.2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES 84 | ||
| 8.3. | CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS 95 | ||
| 8.4. | OPERATING SEGMENT INFORMATION 98 | ||
| 8.5. | NOTES RELATING TO THE STATEMENT OF FINANCIAL POSITION 99 | ||
| 8.6. | NOTES RELATING TO THE STATEMENT OF COMPREHENSIVE INCOME109 | ||
| 8.7. | FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT117 | ||
| 8.8. | RELATED-PARTY TRANSACTIONS122 | ||
| 8.9. | COMMITMENTS 122 | ||
| 8.10. | FEES PAID TO AUDITORS FOR AUDIT AND OTHER ACTIVITIES123 | ||
| 8.11. | EVENTS AFTER THE REPORTING PERIOD123 | ||
| 9. | STATUTORY ACCOUNTS124 | ||
| 9.1. | CONDENSED STATUTORY ANNUAL ACCOUNTS124 | ||
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The Company published its Annual Report in English. The Company has also prepared a French translation of this Annual Report and is responsible for the consistency between the French and English version of this Annual Report.
Deloitte Réviseurs d'Entreprises SRL, a civil company having the form of a co-operative company with limited liability organized and existing under the laws of Belgium, with registered office at Gateway building, Luchthaven Nationaal 1, boite J, 1930 Zaventem, Belgium, represented by Mrs. Julie Delforge (member of the Belgian Institut des Réviseurs d'Entreprises/Instituut voor Bedrijfsrevisoren) is appointed statutory auditor of the Company, for a term of three years ending immediately following the adjournment of the annual general shareholders' meeting of the Company to be held in 2022, resolving upon the financial statements for the fiscal year ended on 31 December 2021.
Certain statements in this Annual Report are not historical facts and are forward-looking statements. Forwardlooking statements include statements concerning the Company's plans, objectives, goals, strategies, future events, future revenues or performance, capital expenditure, research and development, financing needs, plans or intentions relating to partnership or acquisitions, competitive strengths and weaknesses, business strategy and the trends which the Company anticipates in the industries and the political, economic, financial, social and legal environment in which it operates and other information that is not historical information.
Words such as "believe", "anticipate", "estimate", "expect", "intend", "predict", "project", "could", "may", "will", "plan" and similar expressions are intended to identify forward-looking statements but are not the exclusive means of identifying such statements.
By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that the predictions, forecasts, projections and other forward-looking statements will not be achieved. These risks, uncertainties and other factors include, amongst other things, those listed in the Section "Risk Factors".
Information relating to markets and other industry data pertaining to the Company's business included in this Annual Report has been obtained from internal surveys, scientific publications, section association studies and government statistics. The Company accepts responsibility for having correctly reproduced information obtained from publications or public sources, and, in so far as the Company is aware and has been able to ascertain from information published by those industry publications or public sources, no facts have been omitted which would render the reproduced information inaccurate or misleading. However, the Company has not independently verified information obtained from industry and public sources. Certain other information in this Annual Report regarding the industry reflects the Company's best estimates based on information obtained from industry and public sources. Information from the Company's internal estimates and surveys has not been verified by any independent sources.
The Company has filed its deed of incorporation and must file its restated articles of association and all other deeds and resolutions that are to be published in the Belgian Official Gazette (Moniteur Belge) with the clerk's office of the commercial court of Charleroi (Belgium), where such documents are available to the public. The Company is registered with the register of legal entities of Charleroi under company number 0882.015.654. A copy of the most recent restated articles of association, the reports of the Board of Directors and the minutes of the shareholders' meeting are also available on the Company's website (www.bonetherapeutics.com) or can be provided upon request to Bone Therapeutics SA, Investor Relations, 37, rue Auguste Piccard, B-6041 Gosselies, Belgium (e-mail: [email protected] and tel: +32 71 12 10 00, fax: +32 71 12 10 01).
The Company prepares annual audited and consolidated financial statements. All financial statements, together with the reports of the Board of Directors and the statutory auditor are filed with the National Bank of Belgium, where they are available to the public. Furthermore, as a Company with shares listed and admitted to trading on Euronext Brussels and Paris, the Company publishes an annual financial report (included its financial statements and the reports of the Board of Directors and the statutory auditor) and an annual announcement prior to the publication of the annual financial report, as well as a half-yearly financial report on the first six months of its financial year. Copies of these documents will be made available on the Company's website (www.bonetherapeutics.com) and STORI, the Belgian central storage platform which is operated by the FSMA and can be accessed via its website (www.fsma.be).
The Company must also disclose price-sensitive information and certain other information relating to the public. In accordance with the Belgian Royal Decree of 14 November 2007 relating to the obligations of issuers of financial instruments admitted to trading on a Belgian regulated market (Arrêté royal relatif aux obligations des émetteurs d'instruments financiers admis à la négociation sur un marché réglementé), such information and documentation will be made available through the Company's website (www.bonetherapeutics.com), press releases and the communication channels of Euronext Brussels.
The Annual Report is available in English and in French. The Annual Report will be made available, free of charge, for the public upon request to:
Bone Therapeutics SA To the attention of Investor Relations Rue Auguste Piccard 37 B-6041 Gosselies Belgium Tel: +32 71 12 10 00 Fax: +32 71 12 10 01 E-mail: [email protected]
An electronic version of the Annual Report is also available on Bone Therapeutics' website (www.bonetherapeutics.com). The posting of this Annual Report on the internet does not constitute an offer to sell or a solicitation of an offer to buy any of the shares to any person in any jurisdiction in which it is unlawful to make such offer or solicitation to such person. The electronic version may not be copied, made available or printed for distribution. Other information on the website of the Company or on another website does not form part of the Annual Report.
Dear shareholders,
Without doubt, 2020 was an extraordinary year. With the COVID-19 pandemic ferociously spreading and wreaking havoc globally, our social and economic fabrics were pushed to their limit, causing enormous physical, mental and financial hardship. The dramatic impact is still being felt until today.
Despite the turbulent year, we have made strong progress with our lead product, the enhanced viscosupplement JTA-004 for the treatment of osteoarthritic pain in the knee which affects an estimated 250 million patients worldwide. After initiating the pivotal phase 3 clinical trial in May, we were able to swiftly complete the recruitment of the 700+ patients before year end. We are now eagerly awaiting the topline results which are anticipated in the third quarter of 2021. If they confirm the superior pain relief that we saw in the previously completed JTA-004 phase 2b study, this will mean a big leap forward towards the commercialization of our first product.
At the same time, we have advanced our core cell therapy asset, ALLOB, further through the clinic, as we recently started dosing the first patients who have incurred a complex, difficult-to-heal tibial fracture in a phase 2b clinical trial. Difficult fractures, even if a bit less frequent due to lock-down activity restrictions, remain an underserved condition with limited therapeutic options, which can result in lifelong disability and amputations. The phase 2b study will enroll +170 patients in over 40 sites across 7 European countries. Besides providing crucial controlled clinical data, a positive outcome of this study could lead to a valuable treatment for these patients at risk of delayed or non-union fractures.
The clinical progress of ALLOB is further complemented with positive 24-month follow-up data from the spinal fusion phase 2a clinical trial. The results demonstrated that patients treated with ALLOB in spinal fusion procedures showed a high fusion rate and benefited from a persistent, clinically meaningful improvement in function and pain throughout the 2-year follow-up period. The favorable clinical outcome was accompanied by a good safety profile. This promising data provides additional clinical evidence for the potential of our unique allogeneic cell therapy platform to address high unmet medical needs in orthopedics and bone related disorder.
In addition to our clinical programs, we have strongly streamlined our cell therapy manufacturing capabilities with a partnership with Catalent, a leading contract manufacturer in the cell therapy space. As part of the agreement, our state-of-the-art manufacturing subsidiary, SCTS, is now part of the Catalent family while we concurrently signed an associated supply collaboration. As a result, this partnership grants us access to Catalent's global network of clinical and commercial manufacturing facilities, and ensures ongoing optimization, sustainability and global reach for the production of ALLOB, significantly increasing our operational flexibility. During the previous years, we have highly optimized the production process of ALLOB to make it consistent, scalable, cost effective and easy to use; factors that are critical for its global commercialization. Consequently, the improved manufacturing process has significantly increased the production yield and product quality while enabling easy shipment and storage at the point of care and is ready for clinical use due to its cryopreserved final form. We have greatly benefited from the decision to implement this optimized production process for the ongoing Phase IIb clinical trial in patients with difficult-to-heal tibial fractures. We were able to produce clinical batches of ALLOB before the study's initiation, which are being shipped to the 40 clinical sites across Europe as the patient recruitment started. And the optimization efforts do not stop here. By collaborating with the cell therapy specialist, Rigenerand, we aim to further improve the process development and manufacturing of our cell therapy platform.
In 2020, we signed a first licensing agreement for ALLOB in China and Southeast Asia. Our Chinese partners Link Health and Pregene have a comprehensive expertise in advanced therapeutics and cell therapies, combined with a proven track record of development and commercial implementation in Chinese and Asian markets and a well-established cell therapy manufacturing capacity. This partnership will generate up to €55M in upfront and milestone payments plus royalties on sales, while dramatically expanding the geographic reach of our bone cell therapies to the vast 1.6B inhabitants of the region.
In addition to this collaboration, we will continue to actively seek partnerships to develop the ALLOB cell therapy platform in other markets and explore additional business opportunities in the U.S. and Europe. Building on the momentum of the pending announcement of topline results from the phase 3 trial, we expect partnership discussions for JTA-004 to intensify over the course of 2021.
With total gross proceeds of €16 million, we have substantially reinforced our financial position to support our future growth. In the process, we are pleased to welcome a new cornerstone shareholder, CPH Banque, underscoring the potential of our current pipeline.
The collaboration with Catalent also economized ALLOB's production resulting in an estimated €2 million annual reduction of fixed costs. The gross proceeds from the acquisition of our manufacturing subsidiary SCTS by Catalent, amounting to €12 million, allowed us to strengthen our balance sheet by restructuring a substantial part of our existing liabilities and greatly reducing our debt burden.
As innovation is an integral part of our DNA, we continue to explore new grounds to create better treatment solutions for our patients. By entering a BioWin consortium with our industry and academic partners Cerhum, 3D-Side, mSKIL and IREC, we extended the use of ALLOB in other orthopedic applications. By combining a highly tailored 3D printed scaffold with the differentiated bone forming cells of ALLOB, the enhanced tissue engineered product is expected to exhibit strong bone-forming activities and stimulate bone regeneration, forming a safer and structurally superior alternative to bone autografts.
Drawing on our 15 years of history of stem cell work, we have built a great wealth of know-how and intellectual property in mesenchymal stromal cell (MSC) biology and cell therapies. We are now at the stage where we can expand this expertise to a broader differentiated MSC based cell and gene therapy treatment portfolio. Taking the advantage of the well-documented immunomodulatory and anti-inflammatory properties of MSCs, we initiated the pre-clinical development, BT-20, a new allogeneic cell therapy product that targets inflammatory conditions. This and other future targets, will further expand the application of our innovative cell therapy platform and broaden our advanced clinical pipeline with potential new breakthrough developments with increased "professionalization" of biology with MSC cells primed for specific therapeutic objectives.
With the actions taken last year and a strong team in place, namely with the appointments of Stefanos Theoharis as Chief Business Officer and Tony Ting as Chief Scientific Officer the company will progress through 2021 poised for the next stage of its development and reengineering to be came a proeminent company in the field of cell and gene therapy through the use of MSCs.
Also, later this year, we expect the results from the JTA-004 phase 3 study in patients with knee osteoarthritis which could be a major value inflection point for our company. Additionally, we continue to engage with the US Food and Drug Administration in preparation of the next studies with ALLOB and JTA-004 in the US, a large and important market.
On behalf of the Board and the management team, we would like to thank all our stakeholders for their unwavering support and the trust they have shown in Bone Therapeutics. We are also extremely proud of the tremendous commitment shown by our teams and collaborators during these challenging times.
Building on the strong foundation of the achievements in 2020, we are confident for 2021, continuing the progress we have already made in moving our allogeneic cell therapy and advanced biological products through clinical development while exploring new innovations that meet critical needs of patients.
Sincerely,
Jean Stéphenne, Chairman
Miguel Forte, CEO
Bone Therapeutics is a leading Belgium based biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late-stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.
The two late phase products (JTA, ALLOB) and their three indications (Knee Osteoarthritis, Difficult factures, and Lumbar spinal fusion) represent over \$12 billion in market value. The annual market size growth varies from 3% (Lumbar Spinal Fusion) to 6% (Knee Osteoarthritis)1 .
In addition, Bone therapeutics has built a strong IP protection with 96 issued or pending patents worldwide (36 for JTA and 60 for ALLOB) covering methods, products and applications.

JTA-004 is a next generation of intra-articular injectable for the treatment of osteoarthritic pain in the knee. Consisting of a unique patented mix of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain.
Osteoarthritis (OA), also known as degenerative joint disease, is the most common chronic joint condition in which the protective cartilage in the joints progressively break down resulting in joint pain, swelling, stiffness and limited range of motion. The knee is one of the joints that are mostly affected by osteoarthritis, with an
MediPoint: Spinal Fusion – Global Analysis and Market Forecasts, December 2016, Global Data
1 MediPoint: Bone Grafts & Substitutes – Global Analysis and Market Forecasts, March 2017, Global Data
Opportunity Analyzer: Osteoarthritis - Analysis and Forecasts to 2026, September 2017, Global Data. Viscosupplementation: Global Analysis and Market Forecasts, April 2017, Global Data
estimated 250 million cases worldwide2 . The prevalence of knee osteoarthritis (KOA) is expected to increase in the coming years due to increasingly aging and obese population. Currently, there is no cure for KOA and treatments focus on relieving and controlling pain and symptoms, preventing disease progression, minimizing disability, and improving quality of life. Most drugs prescribed to KOA patients are topical or oral analgesics and anti-inflammatory drugs. Ultimately, severe KOA led to highly invasive surgical interventions such as total knee replacement.
In a completed Phase IIb study involving 164 patients, JTA-004 showed an improved pain relief at 3 and 6 months compared to Hylan G-F 20, the global market leader in osteoarthritis treatment.

JTA-004 is currently in Phase III development. The ongoing Phase III study is a controlled, randomized, double-blind trial. It is evaluating the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee up to 12 months, compared to placebo or Hylan G-F 20, the leading osteoarthritis treatment on the market. The study is being conducted in 22 centers across six European countries as well as Hong Kong involving more than 700 patients. Bone Therapeutics recently completed patient recruitment of the study. Patients are now being monitored in follow up with topline results anticipated in Q3 2021.
ALLOB is Company's off-the-shelf, allogeneic cell therapy platform consisting of human allogeneic boneforming cells derived from ex-vivo cultured bone marrow mesenchymal stromal cells (MSC) from healthy adult donors, offering numerous advantages in product quality, injectable quantity, production, logistics and cost as compared to an autologous approach.
To address critical factors for the development and commercialization of cell therapy products, Bone Therapeutics has established a proprietary, optimized production process that improves consistency, scalability, cost effectiveness and ease of use of ALLOB. This optimized production process significantly increases the production yield, generating 100,000 of doses of ALLOB per bone marrow donation. Additionally, the final ALLOB product will be cryopreserved, enabling easy shipment and the capability to be stored in a frozen form at the hospital level. The process will therefore substantially reduce overall production costs, simplify supply chain logistics, improve patient accessibility, and facilitate global commercialization.
2 Vos et al., A systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380:2163-96

Currently, ALLOB targets two indications: difficult tibial fractures and lumbar spinal fusion.
Although the majority of fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the most severe cases. Several factors can increase the risks of delayed healing complications like, for example, smoking, violent shocks (for example, due to a road accident) or even the type of fracture (an open fracture). The location of the fracture is also an important factor: among the bones of the arms and legs, the tibia is known for being the most at risk for complications. Tibial fractures with several risk factors could lead to complications such as delayed union and greatly reduce the quality of life. To date, there is no treatment for fractures considered at risk of delayed complications. The current practice on diagnosis of complications is to wait at least 6-12 months before considering alternative interventions to promote fracture healing.
Constituted of bone cells produced from the bone marrow of healthy adult donors, ALLOB, has shown to be capable of forming bone and repairing fractures in preclinical studies. When directly injected into a fracture, ALLOB should therefore promote the healing of the fracture by re-establishing a healthy environment, stimulate bone healing, reduce healing time, reduce complications, and improve the quality of life for the patient.
ALLOB has shown preliminary evidence of effectiveness in the treatment of delayed bone healing fractures in a Phase I/IIa study involving 21 patients. The study demonstrated efficacy in bone formation and improvement of general health status. At six months post administration, 100% of the patients met the primary endpoint, defined as an increase of at least two points on the radiological Tomographic Union Score (TUS) or an improvement of at least 25% of the clinical Global Disease Evaluation (GDE) score vs. baseline. Radiological evaluation of fracture healing showed an improvement of 3.9 points on average on the TUS scale, nearly twice the required minimum of 2.0 points. This minimum two-point increase was achieved by 16 out of 21 patients (76%). The Global Disease Evaluation (GDE) score to assess the general health condition of the patient, improved 48% on average. The minimum 25% improvement was achieved by 16 out of 21 patients (76%).

ALLOB is currently being evaluated in a Phase IIb study in patients with difficult-to-heal tibial fracture. The Phase IIb study is a randomized, double-blind, placebo-controlled study. In this study, the potential of ALLOB to accelerate fracture healing and prevent late-stage complications in patients with difficult fractures in the shinbone (tibia), will be tested and compared to placebo, on top of standard of care after a follow-up period of 6 months. ALLOB will be applied by a single percutaneous injection 24-96 hours post reduction surgery in patients with fresh tibial fractures at risk for delayed or non-union. The study has been approved in 7 European countries (Belgium, Czech Republic, France, Germany, Hungary, Poland and Spain). The study is expected to enroll 178 patients in over 40 sites. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment in January 2021.
Due to ageing populations and sedentary lifestyles, the number of people suffering from degenerative spine disorders continues to increase. Today, spinal fusion procedures are performed to relieve pain and improve patient daily functioning in a broad spectrum of degenerative spine disorders. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft or demineralized bone matrix – placed into the intervertebral space – for fusing an unstable portion of the spine and immobilizing a painful intervertebral motion segment.
Over 1,000,000 spinal fusion procedures are performed annually in the US and EU, of which half at lumbar level and the market is growing at a rate of 5% per year. Although spinal fusion surgery is routine, non-fusion, slow progression to fusion and failure to eliminate pain are still frequent with up to 35% of patients not being satisfied with their surgery.
A multi-center, open-label proof-of-concept Phase IIa study was designed to evaluate the safety and efficacy of ALLOB administered in addition to the standard of care procedure in which an interbody cage with bioceramic granules is implanted into the spine to achieve fusion of the lumbar vertebrae. The main endpoints of the 24-month follow-up analysis included safety and radiological assessments to evaluate vertebrae fusion (continuous bone bridges) and clinical assessments to evaluate improvement in patients' functional disability as well as reduction in back and leg pain. The study evaluated 30 patients treated with ALLOB, 29 patients attended the 24-month visit.
In the Phase IIa study, ALLOB Lumbar Spinal Fusion showed promising 24-month results in bone formation and disability reduction. The 24-month data showed a high percentage of successful lumbar vertebrae fusion of 90%. Patients also continued to experience important clinical improvements in function and pain, from as early as six months after treatment, up to the 24-month follow-up period.

The Company is conducting several partnerships in product licensing, manufacturing, process development and research. These transactions reposition Bone Therapeutics around its focus on product and platform development.
| LICENSING | MANUFACTURING | PROCESS DEVELOPMENT | RESEARCH | |
|---|---|---|---|---|
| Partner, | · 9 : CC = NE | Catalent. | 3D-SIDE IREC A THEO |
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| Deal | Exclusive license to ALLOB and related IP and knowhow China, Hong Kong, Macau, Taiwan, Singapore, Thailand, South Korea |
Catalent acquired Bone Therapeutics' cell therapy manufacturing facilities Catalent will manufacture and supply ALLOB |
Collaboration focusing on product and process development for Bone Therapeutics' cell therapy products as they advance towards patients |
Research Collaboration for the development of patient-specific scaffolds for use in combination with ALLOB |
| Financia | €55 million in total upfront and milestone payments plus tiered double-digit rovalties on net sales |
€12 million in total payments to Bone Therapeutics |
· €3 million in total grant tunding from BioWin, the health cluster of the Wallonia Region (Belgium) |
|
| Notes | Link Health and Pregene will conduct and finance development in Asia |
Catalent is a leading global CDMO for drugs, biologics, gene therapies, and consumer health products |
· Potential for Bone Therapeutics to broaden its therapeutic targets and explore new mechanisms of action with potential gene modifications for its therapeutic portfolio |
The new biocompatible scaffolds will be modelled with state-of-the-art software and 3D printed |
In October 2020, Bone Therapeutics, Link Health and Pregene signed an exclusive license agreement for the manufacturing, clinical development and commercialization of Bone Therapeutics' allogeneic, off-the-shelf, bone cell therapy platform ALLOB in China (including Hong Kong and Macau), Taiwan, Singapore, South Korea, and Thailand.
Under the agreement, Bone Therapeutics is eligible to receive up to €55 million in development, regulatory and commercial milestone payments. Bone Therapeutics is also entitled to receive tiered double-digit royalties on annual net sales of ALLOB. Bone Therapeutics retains development and commercialization rights to ALLOB in all other geographies outside of those covered by this agreement.
In October 2020, Bone Therapeutics signed share purchase and supply agreements with Catalent Pharma Solutions, Inc., the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products The agreements streamline and economize the manufacturing operations of ALLOB, Bone Therapeutics' allogeneic cell therapy product.
Under the terms of the transaction, Catalent acquires Bone Therapeutics' cell therapy manufacturing subsidiary, SCTS, for gross proceeds of €12 million. Following completion of the transaction, the SCTS manufacturing infrastructure and production operating teams became part of Catalent's Cell & Gene Therapy division.
Concurrently, Bone Therapeutics and Catalent entered into associated supply agreements. This grants Bone Therapeutics access to Catalent's global network of clinical and commercial manufacturing facilities, and ensures ongoing optimization, sustainability and a global reach for the production of ALLOB as the product heads through clinical development and anticipated commercialization.
In January 2021, Bone Therapeutics and Rigenerand SRL, the biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology, signed a first agreement for a process development partnership.
The scope of collaborations between Bone Therapeutics and Rigenerand aims to focus on different aspects of product and process development for Bone Therapeutics' expanding therapeutic portfolio. Rigenerand will contribute to improving the processes involved in the development and manufacture of Bone Therapeutics' MSC based allogeneic differentiated cell therapy products as they advance towards patients. The first collaboration between the two organizations will initially focus on augmented professional bone-forming cells – cells that are differentiated and programmed for a specific task. There is also potential for Bone Therapeutics to broaden its therapeutic targets and explore new mechanisms of action with potential gene modifications for its therapeutic portfolio.
In November 2020, Bone Therapeutics joined a research collaboration with expert industry and academic partners, Cerhum, 3D-Side, mSKIL and IREC, to develop biologically active, patient-tailored, 3D printed, bioresorbable implants enriched with Bone Therapeutics' allogeneic bone forming cells, ALLOB. The consortium, named Bonerec, was established under the "Competitiveness Clusters" framework of the Belgian Walloon Health Association, BioWin, and received €3 million non-dilutive funding from the Walloon Government.
This 28-months collaboration aims to develop biologically active, custom-made tissue engineered bone implants that could replace bone transplants harvested from patient's own bones (autografts). By combining the tailored scaffold with Bone Therapeutics' differentiated bone forming cells, ALLOB, the enhanced tissue engineered product is expected to exhibit strong bone-forming activities and stimulate bone regeneration. The aim of the resultant cell-enriched implant is to form a safe and structurally superior alternative to bone autografts.
Dear Shareholders,
We are pleased to present you our annual report including the consolidated financial statements for the accounting year that ended 31 December 2020 prepared in accordance with the International Financial Reporting Standards (IFRS) as adopted by the European Union.
In October 2020, Bone Therapeutics announced positive 24-month results for the Phase IIa study with the allogeneic cell therapy product, ALLOB, in patients undergoing lumbar spinal fusion procedures. 90% of patients showed bone fusion as well as strong clinical improvements in function and pain at 24 months followup period with a good product safety profile. The next development steps for ALLOB in this indication are planned to be considered after the results of the ongoing ALLOB clinical study in tibial fractures.
In December 2020, Bone Therapeutics succeeded in completing the patient recruitment and treatment in the pivotal Phase III clinical study with the improved viscosupplement, JTA-004, in patients with knee osteoarthritis on schedule. Patients are currently being monitored in follow up. Patient study compliance and retention remains high despite pandemic effects. The study is on schedule to have top line efficacy data available in Q3 2021 with continued monitoring until year end and full results available in 2022.
In January 2021, Bone Therapeutics treated the first patient in the Phase IIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures, following receiving regulatory approval in all seven European countries designated for the trial. The study is expected to enroll 178 patients in over 40 sites. Early recruitment rates were very promising but in March and April the rate of recruitment has slowed slightly. The current recruitment is 12 patients instead of the planned 20 at this stage. This is due to pandemic-related factors that have affected operational activities including site opening, materials availability and patient availability. Bone Therapeutics' clinical team, in partnership with the clinical research organization, has already instituted corrective actions to mitigate these issues, including training, information, sharing of best practices and will continue to actively monitor study progress. At this stage we do not expect these delays to have a material effect on the expected completion of recruitment in H1 2022 and the planned top line results date in H2 2022.
In March 2020, the company appointed Stefanos Theoharis, PhD as Chief Business Officer, further strengthening its management team. With more than 15 years of business development experience in the pharma and biotech industry, specifically in the cell and gene therapy space, Stefanos will be responsible for the company's corporate development activities and the execution of its business strategy.
In August 2020, Bone Therapeutics was granted EUR 1.0 million in non-dilutive funding under the form of recoverable cash advances from the Walloon Region, Belgium. This funding will provide additional financial support to advance its current phase III clinical study with JTA-004.
Also in August 2020, the Company received two additional grants with a total value of EUR 0.6 million from the Belgian Walloon Region for research and initial preparatory steps towards clinical development of BT-20, its new allogeneic and off-the-shelf cell therapy product, leveraging its expertise in Mesenchymal Stromal Cell (MSC) biology to expand its portfolio from orthopedics and bone diseases to inflammatory conditions.
In October 2020, Bone Therapeutics signed an exclusive license agreement with Link Health Pharma Co., Ltd and Shenzhen Pregene Biopharma Company, Ltd for the manufacturing, clinical development and commercialization of ALLOB in Greater China, Taiwan, Singapore, South Korea, and Thailand. Terms of the agreement included up to €55 million total in upfront and milestone payments, with €10 million expected in the next 2 years as well as tiered double-digit royalties on net sales.
Subsequently, Bone Therapeutics signed a manufacturing collaboration with Catalent, Inc. to streamline the production of ALLOB. Under the terms of the share purchase agreement, Catalent acquired Bone Therapeutics' cell therapy manufacturing subsidiary, Skeletal Cell Therapy Support SA (SCTS), for gross proceeds of €12 million. The equity purchase price, net of SCTS's debt (€3 million), cash adjustments, and taking into account the restructuring of some Bone Therapeutics' existing liabilities (€3 million), generated net proceeds of approximately €6 million.
In November 2020, Bone Therapeutics joined a research collaboration with expert industry and academic partners to develop biologically active, patient-tailored, 3D printed, bioresorbable implants enriched with Bone Therapeutics' allogeneic bone forming cells, ALLOB. Established under the "Competitiveness Clusters" framework of the Belgian Walloon Health Association, BioWin, the consortium received €3 million non-dilutive funding, of which €400k are allocated to Bone Therapeutics, from the Walloon Government in Belgium.
In December 2020, Bone Therapeutics successfully raised €10 million through a private placement with current and new institutional investors both in Europe and in the US and welcomed CPH Banque as new cornerstone investor to support its long-term growth.
The following table includes information relating to the Company's audited statement of comprehensive income for the years ended 31 December 2020 and 31 December 2019.
| (in thousands of euros) | 2020 | 2019 |
|---|---|---|
| Revenue | 1,000 | 0 |
| Other operating income | 2,666 | 2,491 |
| Total operating income | 3,666 | 2,491 |
| Research and development expenses | (15,416) | (7,501) |
| General and administrative expenses | (3,267) | (2,936) |
| Operating profit/(loss) | (15,017) | (7,946) |
| Interest income | 24 | 1,041 |
| Financial expenses | (747) | (602) |
| Exchange gains/(losses) | (13) | (15) |
| Share of profit/(loss) of associates | 0 | 0 |
| Result Profit/(loss) before taxes | (15,754) | (7,522) |
| Income taxes | (78) | 0 |
| Net Income (Loss) from continuing operations | (15,832) | (7,522) |
| Net Income (Loss) from discontinued operations | 3,891 | (2,813) |
| TOTAL COMPRENHENSIVE INCOME (LOSS) OF THE PERIOD | (11,940) | (10,336) |
| Basic and diluted loss per share (in euros) – continuing operations | (1.35) | (0.79) |
| Basic and diluted loss per share (in euros) – discontinued operations | 0.33 | (0.29) |
| Profit/(loss) for the period attributable to the owners of the Company | (11,940) | (10,461) |
| Profit/(loss) for the period attributable to the non-controlling interests | 0 | 125 |
| Total comprehensive income for the period attributable to the owners of the Company | (11,940) | (10,461) |
| Total comprehensive income for the period attributable to the non-controlling interests | 0 | 125 |
In 2020, the Company recognized an upfront payment for an amount of €1.00 million from licensee Link Health & Pregene, after signing a license agreement in October 2020. The Company grants exclusive license to Link Health and Pregene for the development and commercialization of ALLOB in Greater China and a number of other major Asian countries.
The total revenues and operating income for 2020 amounted to €2.67 million compared to €2.49 million in 2019. Other operating income is mainly as a result of grants from the Walloon Region ("Recoverable Cash Advances – RCAs") which in total amounted to €1.20 million in 2020 (compared to €1.25 million in 2019). In addition, the company benefited from the special regime employing scientific staff through the recovery of company withholding tax for an amount of €0.33 million, an investment tax credit for an amount of €0.86 million and €0.28 million in patent, reinvoicing and other subsidies.
R&D expenses in 2020 were at €15.42 million compared to €7.50 million in 2019. The increase is mainly related to the increase in R&D operating expenses from clinical operations with the "CRO" for the Clinical trial for JTA in Phase III and ALLOB in Phase IIB for the difficult fractures.
General and administrative expenses for the full year 2020 amounted to €3.27 million compared to €2.94 million over the same period last year. The increase is mainly the result of the non-recurrent fees related to the deals happened during the year.
The operating loss in 2020 was at €15.02 million. Last year, the company reported an operating loss of €7.95 million.
In 2020, the Company presented a net financial loss of €0.74 million compared with a net financial profit of €0.42 million in 2019. In 2019, on one hand, the Company recognized an impact of €1.04 million for the stop of PREOB (which corresponds to the part for which reimbursement is turnover-independent) and on the other hand, the financial expenses were mainly impacted by the interests paid for €0.34 million and by the adaptation of the valuation of the PUT option for €0.28 million. In 2020, the net financial loss was mainly impacted by the recognition of the interest paid during the year.
In 2020, the Company presented profit for an amount €3.89 million compared to a loss of €2.81 million in 2019 in relation of the discontinued activities. In November 2020, the Company sold its subsidiary Skeletal Cell Therapy Support SA ("SCTS") to Catalent Gosselies SA. Under the terms of the transaction, Catalent acquired Bone Therapeutics' cell therapy manufacturing subsidiary, SCTS, for gross proceeds of €12 million. The equity purchase price, net of SCTS's debt (€3.00 million), cash adjustments, and taking into account the restructuring of some Bone Therapeutics' existing liabilities (€3.00 million), generates net proceeds of approximately €6.30 million. The recognized profit is explained by the capital gain realized on the sale of SCTS' shares.
The reported net loss in 2020 amounted to €11.94 million or €1.35 loss per share for the continuing operations and a reported profit per share of €0.33 for the discontinued operations (on an undiluted basis). In 2019, the Company had a net loss of €10.34 million, equivalent to a total loss per share of €1.08 (on an undiluted basis).
The table below shows the audited consolidated balance sheet on 31 December 2020 and 2019.
| ASSETS (in thousands of euros) |
31/12/2020 | 31/12/2019 |
|---|---|---|
| Non-current assets | 6,019 | 10,660 |
| Intangible assets | 28 | 28 |
| Property, plant and equipment | 226 | 6,100 |
| Investments in associates | 12 | 332 |
| Financial assets | 1,296 | 140 |
| Deferred tax assets | 4,456 | 4,059 |
| Current assets | 18,817 | 11,733 |
| Trade and other receivables | 3,840 | 3,025 |
| Other current assets | 328 | 75 |
| Cash and cash equivalents | 14,648 | 8,633 |
| TOTAL ASSETS | 24,835 | 22,393 |
Total assets at the end of December 2020 amounted to €24.84 million compared to €22.39 million at the end of December 2019, mainly impacted by the current assets.
The current assets increased from €11.73 million to €18.82 million at the end of December 2020. The increase is mainly related to the variation of the cash and cash equivalents which showed an increase of €6.02 million compared to last year (mainly following the capital raise in December 2020 with a total gross amount of €9.92 million.
The trade and other receivables also increased mainly explained by:
expense declarations in function of the progress of the works) for a total of €2.49 million which result in a net decrease of €0.13 million.
The non-current assets decreased from €10.66 million to €6.02 million at the end of December 2020. The decrease is mostly related to the property, plant and equipment and partly offset by the financial assets (recognition of the bank warranty of €1.20 million in relation with the deal with Catalent) and the deferred tax assets. The building and most of the laboratory equipment have been sold in the context of the transaction with Catalent in October 2020. Deferred tax assets totaling €4.46 million represent a tax credit on investment in R&D reimbursable in the foreseeable future (spread over the next seven years).
| EQUITY AND LIABILITIES (in thousands of euros) |
31/12/2020 | 31/12/2019 |
|---|---|---|
| Equity attributable to owners of the parent | 3,325 | 2,048 |
| Share capital | 8,415 | 5,454 |
| Share premium | 67,594 | 58,026 |
| Retained earnings | (73,080) | (61,586) |
| Other reserves | 396 | 154 |
| Non-controlling interests | 0 | 0 |
| Total equity | 3,325 | 2,048 |
| Non-current liabilities | 11,720 | 11,006 |
| Interest bearing borrowings | 11,720 | 11,006 |
| Other non-current liabilities | 0 | 0 |
| Current liabilities | 9,790 | 9,339 |
| Interest bearing borrowings | 3,077 | 2,709 |
| Trade and other payables | 5,514 | 3,841 |
| Other current liabilities | 1,199 | 2,788 |
| Total liabilities | 21,509 | 20,344 |
| TOTAL EQUITY AND LIABILITIES | 24,835 | 22,393 |
Equity increased from €2.05 million at the end of December 2019 to €3.33 million at the end of December 2020, as a result of the share capital and share premium's increase (amounting €13.50 million) and recognition of the transaction costs for the equity transaction for an amount of €0.97 million, by the loss of 2020 for an amount of €11.94 million, for the allocation of the share-based payment reserve for €0.27 million and by the recognition of a specific reserve linked to the convertible bonds and warrants and other reserves for for €0.47 million.
Liabilities amounted to €21.51 million in 2020 compared to €20.34 million at the end of December 2019, representing an increase of €1.17 million.
Current liabilities remained stable compared to last year. The increase in trade and other payables is mostly offset by the decrease of the other current liabilities, with the buyback of the non-controlling interest of SCTS (the PUT option) in order for the Company to buy-back the shares of the minority shareholders of SCTS.
The non-current liabilities slightly increased compared to last year and amounted to €11.72 million the end of December 2020. The non-current liabilities are impacted by the recognition of the fair value of the convertible bonds placement of May 2020 for an amount of €3.60 million, offset by the reimbursement of all the financial libailities of SCTS for an amount of €2.76 million (and €0.34 million in current liabilities).
The following table sets forth the Company's consolidated cash flow statement for the years ended 31 December 2020 and 2019. This table is presented in further detail under the section "Consolidated statement of cash flows" of the consolidated financial statements for the period ended 31 December 2020.
| CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands of euros) |
For the twelve-month period ended 31 December |
|
|---|---|---|
| 2020 | 2019 | |
| Operating profit/(loss) | (17,448) | (11,174) |
| Adjustments non-cash | (1,576) | (2,288) |
| Movements in working capital | 708 | (188) |
| Cash received from grants/licenses | 2,312 | 3,287 |
| Income tax paid | (78) | (38) |
| Net cash used in operating activities | (16,082) | (10,401) |
| Proceed from the sale of SCTS Net cash used in investing activities |
12,000 11,909 |
0 (302) |
| Proceeds from government loans | 748 | 815 |
| Proceeds from loans from bank/related parties | 5,550 | 0 |
| Repayment of loans and interests paid | (7,557) | (1,646) |
| Payment to acquire Non-controlling interests | (1,956) | 0 |
| Guarantee facilities | (1,200) | 0 |
| Net Proceeds from equity instruments/convertible bonds/subordinated loans | 14,603 | 11,993 |
| Net cash generated from financing activities | 10,187 | 11,163 |
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS CASH AND CASH EQUIVALENTS at beginning of year CASH AND CASH EQUIVALENTS at end of year |
6,132 8,633 14,648 |
459 8,174 8,633 |
Cash used for operating activities amounted to €16.09 million for the full year 2020 compared to €10.40 million for the full year 2019.
Total operating loss for the period amounted to a loss of €17.45 million compared to a loss of €11.17 million over the same period in 2019. The increase of the net loss in 2020 is mainly explained by an increase of the clinical expenses for the JTA-004 clinical trial Phase III and ALLOB clinical trial Phase IIB in tibial fractures.
Adjustments for non-cash items amounted to €1.58 million compared to €2.29 million during the previous year relating to depreciation, share-based payments and recognition of grant income from RCA's, patent subsidies and tax credit. Working capital was positively impacted for the full year 2020 for an amount of €0.70 million mainly explained by an increase of trade payables and of the trade receivables.
Actual cash received in 2020 for the grants and regulatory milestones amounted to €2.31 million compared to €3.29 million in 2019.
Cash flow from investing activities is mainly impacted by the proceed obtained from Catalent Gosselies SA for the sale of SCTS for an amount of €12.00 million.
Cash flow from financing activities amounted to €10.19 million for 2020 compared with €11.16 million in 2019.
Financial cash inflows during 2020 are as follows:
Financial cash outflows during 2020 are as follows:
On 31 December 2020, the Group employs 30 employees in total. The table below shows the evolution of employment since 2018 and does not take into account the temporary workers, consultants and the management members. The Group has transferred a total of 17 FTE to Catalent Gosselies SA
| 2020 | 2019 | 2018 | |
|---|---|---|---|
| As of 31 December, | |||
| R&D | 25 | 53 | 81 |
| Administration | 5 | 5 | 9 |
| Total of Bone Therapeutics SA | 30 | 58 | 90 |
Sixteen percent of employees have obtained a doctorate and 30% a master's degree. Scientific specialization domains include cellular and molecular biology, pharmaceutical sciences, veterinary medicine, physiology and life sciences.
Reference is made to Section 4.7.2 "Risks Analysis".
The recent outbreak of the novel strain of coronavirus (SARS-CoV-2) causing the severe respiratory illness, coronavirus disease 2019 (COVID-19), originated in Wuhan, China, in December 2019 and has since spread to multiple countries, including the United States and Europe. On 11 March 2020, the World Health Organization declared the outbreak of a global pandemic and recommended containment and mitigation measures worldwide. The spread of COVID-19 and the resulting health measures have impacted the global economy and our business operations, including potential delay of our clinical trial activities. Some factors from the COVID-19 outbreak that the Company believes will adversely affect the timely enrollment and continuation of its clinical trials, at least on a temporary basis, include:
In addition, the Company is taking temporary precautionary measures intended to help minimize the risk of the virus to its employees, including temporarily requiring all employees to work remotely, suspending all nonessential travel worldwide for its employees and discouraging employee attendance at industry events and inperson work-related meetings, which could negatively affect the Company's business.
The extent to which the recent global COVID-19 pandemic impacts our business will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among other things, but prolonged closures or other business disruptions may negatively affect its operations and the operations of its agents, contractors, consultants or collaborators, which could have a material adverse impact its business, results of operations and financial condition.
Based Based on annual 2021 projected cash burn in a range of €16.00 million to €17.00 million and considering a cash position end of 2020 of about €14.65 million, the Company anticipates having sufficient cash to carry out its business objectives until November 2021.
The Directors remain focused on the Company's liquidity and expect to manage business operations in the next 12 months whilst maintaining adequate liquidity.
In view of the Company significant progress in its clinical programs leading to collection of milestones payment from our partners, combined with ongoing discussions with business and financial partners to obtain sufficient funds, the Board is of the opinion that it is appropriate to prepare the financial statements of the Company under the assumption of going concern.
The annual consolidated financial statements on 31 December 2020 were authorized for issue by the Board of Directors of the Company on 28 April 2021. Accordingly, events after the reporting period are those events that occurred between 1 January 2021 and 28 April 2021.
Post period, in January 2021, Bone Therapeutics signed a first agreement for a process development partnership with the mesenchymal stromal cell (MSC) specialist, Rigenerand. This first collaboration will focus on further developing and enhancing Bone Therapeutics' bone-forming cells with the potential to broaden their therapeutic targets and explore new mechanisms of action with potential gene modifications for Bone Therapeutics' therapeutic portfolio.
At the end of March 2021, Bone Therapeutics appointed the stem cell therapy industry veteran, Anthony Ting, PhD, as Chief Scientific Officer. Backed by two decades of expertise in translational clinical development with adult stem cell therapies, Dr. Ting will be responsible for Bone Therapeutics' research activities. His immediate focus will be the further expansion of Bone Therapeutics' pipeline, leveraging internal know-how and external collaborations on novel, specialized cell therapy products with enhanced efficacy, using differentiated and modified MSCs.
Bone Therapeutics aims to report topline results for the 3-month primary endpoint and 6-month follow-up period in the third quarter of 2021 for its pivotal Phase III clinical study with the improved viscosupplement, JTA-004, in patients with knee osteoarthritis.
For the ongoing Phase IIb ALLOB clinical study in difficult tibial fractures, to compensate the impact of the pandemic on site activities due to staff availability and patient recruitment due to less accidents, Bone Therapeutics and its partners will continue to take action to intensify the recruitment through training, information, best practices sharing and close monitoring of progress. The initial result of these activities has already impacted positively patient recruitment.
Bone Therapeutics will continue to hold discussions with potential partners to explore business opportunities as JTA-004 is approaching the announcement of pivotal Phase III topline results and ALLOB is being evaluated in a double-blind, placebo-controlled, proof-of-concept Phase IIb study.
Bone Therapeutics will continue its discussions with the US FDA (Food and Drug Administration) in preparation for the next steps in the clinical development of JTA-004 and ALLOB in the US.
Bone Therapeutics plans to continue to expand its allogeneic differentiated MSC based cell therapy platform, beyond ALLOB, into other therapeutic indications.
Disciplined cost and cash management will remain a key priority. The net cash burn for the full year 2021 is expected to be in the range of €16-17 million, assuming normal operation as the effect of the ongoing COVID-19 epidemic cannot be excluded. The situation will be actively and closely monitored. The company anticipates having sufficient cash to carry out its business objectives into November 2021.
At the date of this Annual Report, the Company has the following affiliate:
• Bone Therapeutics USA Inc. incorporated on 26 March 2015.

The Company held 100% of the shares issued by Skeletal Cell Therapy Support, a limited liability company (société anonyme) with registered office at rue Auguste Piccard 37, 6041 Gosselies, Belgium and with company number 0841.570.812 (RLE Charleroi) until 13 November 2020. As from this date, Skeletal Cell Therapy Support SA has been sold to Catalent Gosselies SA.
This section summarizes the rules and principles by which the corporate governance of the Company is organized. Those rules and principles are based on the Corporate Governance Charter of the Company which has been approved by the Board of Directors on 25 August 2020 and which is based on the Corporate Governance Code 2020 (CBGE 2020) made mandatory by the Royal Decree of 12 May 2019 designating the corporate governance code to be respected by listed companies. This charter can be obtained free of charge at the registered office of the Company and is available on the Company's website (www.bonetherapeutics.com, under the section investors/governance).
Pursuant to the Belgian Act of 6 April 2010 on the reinforcement of the corporate governance of listed companies and autonomous government enterprises and the amendment of the rules on the exclusion of employment in the bank and financial sector (Loi visant à renforcer le gouvernement d'entreprise dans les sociétés cotées et les entreprises publiques autonomes et visant à modifier le régime des interdictions professionnelles dans le secteur bancaire et financier), as implemented by the Royal Decree of 6 June 2010 regarding the designation of the corporate governance code on listed companies (Arrêté Royal portant désignation du Code de gouvernement d'entreprise à respecter par les sociétés cotées), Belgian listed companies should comply with the Belgian Code for Corporate Governance issued on 12 March 2009 by the Belgian Corporate Governance Committee (the "Corporate Governance Code" or "CGC"), unless it discloses the justification why it has decided to deviate from the provisions of the Corporate Governance Code (the rule of comply or explain).
The Company's corporate governance charter (the "Corporate Governance Charter") was adopted in accordance with the recommendations included in the Corporate Governance Code.
The Board of Directors of the Company intends to comply with the Belgian Corporate Governance Code, except in relation to the following matters:
The Board of Directors will review the Corporate Governance Charter from time to time and adopt such amendments thereto as it deems necessary and appropriate. The Corporate Governance Charter and the Company's articles of association are available at the Company's website and at its registered office and can be obtained free of charge.
The Board of Directors is the main decision-making body of the Company and has full power to perform all acts that are necessary or useful to accomplish the Company's corporate purpose, save for those acts for which only the shareholders' meeting of the Company has the required powers in accordance with applicable laws or the Company's articles of association. The responsibility for the management of the Company is entrusted to the Board of Directors as a collegial body.
The Board of Directors pursues the long-term success of the Company by providing entrepreneurial leadership, while assessing and managing the risks of the Company.
The Board of Directors is composed of at least three members as set out in the articles of association and the Corporate Governance Charter.
At least half of the members of the Board of Directors are Non-Executive Directors, and at least three members of the Board of Directors are Independent Directors, within the meaning of inter alia Article 7:87 §1 of the Belgian Code of Companies and Associations.
The members of the Board of Directors are appointed by the shareholders' meeting of the Company for a renewable term of maximum four years. If a director mandate becomes vacant, the remaining members of the Board of Directors will have the right to temporarily appoint a new director to fill the vacancy. The shareholders' meeting can revoke the mandate of any director at any time.
In principle the Board of Directors meets at least four times a year and whenever a meeting is deemed necessary or advisable for its proper functioning. A meeting of the Board of Directors is validly constituted if there is a quorum, which requires that at least half of the members of the Board of Directors or present or represented during the board meeting. In any event, the Board of Directors can only validly deliberate if at least two Directors are present in person.
At the IPO, the board was composed of eleven, mostly local members. In 2017, the Board was adapted to include international experts in cell therapy, biotech and orthopedics. From 2018, the number of members has been reduced to nine members, 7 Independent and 2 Executive Directors. From 2019, the number of members has been reduced to seven members, 5 Independent and 2 Executive Directors.
The table below provides an overview of the mandates held in 2020 and the current mandates at the date of the Annual Report:
| Name | Position | Start or renewal of mandate |
End of mandate |
Nature of mandate |
Professional address |
|---|---|---|---|---|---|
| Innoste S.A., with as permanent representative Jean Stéphenne |
Chairman | 2018 | 2021 | Independent | Avenue Alexandre 8, 1330 Rixensart, Belgium |
| mC4Tx SRL, with as permanent representative Miguel Forte |
Managing Director |
2020 | 2022 | Executive | Rue du Moulin 12, 1330 Rixensart, Belgium |
| Claudia D'Augusta | Director | 2018 | 2023 | Independent | Calle Estrelas 5, 28224 Pozuelo De Alarcon, Madrid, Spain |
| Castanea Management SARL with as permanent representative Damian Marron |
Director | 2020 | 2023 | Independent | 401 Chemin du Val Martin, 06560 Valbonne, France |
| ClearSteer Consulting LLC with as permanent representative Gloria Matthews |
Director | 2020 | 2023 | Independent | 880 Roswell Rd, Suite 430, Roswell, GA, United States |
| Jean-Paul Prieels | Director | 2017 | 2021 | Independent | Chemin du Gros Tienne 61, 1380 Lasne, Belgium |
| Finsys Management SRL with as permanent representative Jean-Luc Vandebroek |
Managing Director |
2018 | 2022 | Executive | Rue Charles Plisnier 25, 1420 Braine-l'Alleud, Belgium |
A brief overview of the relevant experience of the Independent Directors in place at the date of the Annual Report is set out below.
At the date of this Annual Report, none of the Directors and the members of the Executive Committee have at any time within at least the past five years:
In 2020, the Board of Directors met 16 times discuss and decide on specific matters. Below is the detail of the attendance:
| BOARD OF DIRECTORS | Number of attendances3 |
|---|---|
| Innoste SA, represented by M. Jean Stéphenne | 16/16 |
| mC4Tx SRL, represented by Miguel Forte | 16/16 |
| Claudia D'Augusta | 16/16 |
| Castanea Management SARL, represented by M. Damian Marron | 16/16 |
| ClearSteer Consulting LLC, represented by Mrs Gloria Matthews | 14/16 |
| M. Jean-Paul Prieels | 16/16 |
| Finsys Management SPRL, represented by Jean-Luc Vandebroek | 16/16 |
Out of the activity report included above, it is clear that the Board as a Company organ has been very active with a strong participation and contribution of all its members during the course of 2020.
It was decided that when board seats become available in the years to come, special efforts will be done to attract new board members of the other gender in accordance with Article 3:6 § 2, 6° of the Belgian Companies Code (and with the law of 28 July 2011) to assure that by 01/01/2021 (for newly listed companies, the legal quota is applicable as from their sixth year on the stock market) the appropriate quorum will be reached. This quota applies to the board as a whole, comprising both executive and non-executive directors. The Company's board currently counts 7 board members of which 2 women. As one third of the board must be female and the minimum is rounded to the closest unit, Bone Therapeutics is currently compliant with the gender diversity requirement.
The Board is responsible for a periodic assessment of its own effectiveness with a view to ensuring continuous improvement in the governance of the Company. The contribution of each director is evaluated periodically in order to, taking into account changing circumstances, be able to adapt the composition of the Board. In order to facilitate such evaluation, the directors give their full assistance to the Nomination and Remuneration Committee and any other persons, whether internal or external to the Company, entrusted with the evaluation of the Directors.
Furthermore, the Board will assess the operation of the Committees at least every two to three years. For this assessment, the results of the individual evaluation of the Directors are taken into consideration. The Chairman of the Board and the performance of his role within the Board are also carefully evaluated. The Nomination and Remuneration Committee should, where appropriate and if necessary, in consultation with external experts, submit a report commenting on the strengths and weaknesses to the Board and make proposals to appoint new Directors or to not re-elect Directors. A director not having attended half the number of meetings of the Board will not be considered for re-election at the occasion of the renewal of his mandate.
In addition, the Non-Executive Directors should regularly (preferably once a year) assess their interaction with the Executive Directors and the Executive Committee. At different occasions, the board together with the executive directors took the opportunity to reflect on how to streamline the interactions between both the non-executive directors and the executive directors including the implementation of a reporting on key performance indicators.
3 Number of attendances compared to the maximum number of attendances considering time of appointment and conflicts of interest. All Directors who were not present, were excused.
The Board of Directors has established a nomination and remuneration committee (the "Nomination and Remuneration Committee") and an Audit Committee (the "Audit Committee"). These committees (the "Committees") have a mere advisory role.
The Board of Directors has determined the terms of reference of each Committee with respect to its respective organization, procedures, policies and activities.
The Audit Committee supports the Board of Directors in fulfilling its monitoring responsibilities in respect of control in the broadest sense.
The Audit Committee is the main contact point of the external auditor. Without prejudice to the legal duties of the Board of Directors, the Audit Committee is entrusted with the development of a long-term audit program encompassing all of the Company's activities, and is in particular entrusted with:
The final responsibility for reviewing and approving the Company's interim and annual financial statements, as presented to the shareholders, remains with the Board of Directors.
The Corporate Governance Charter of the Company states that the Audit Committee is composed out of at least three members, all its members being Non-Executive Directors. At least one of the members of the Audit Committee is an independent Director, who has accounting and auditing expertise. This expertise in accounting and auditing implies a degree of higher studies in economics or finance or relevant professional experience in those matters.
The Audit Committee is chaired by one of its members, who may not be the chairman of the Board of Directors.
The duration of the mandate of a member of the Audit Committee will not exceed the duration of his/her mandate as director of the Company.
The composition of the Audit Committee is as follows:
| Name | Position | Professional address |
|---|---|---|
| Claudia D'Augusta | President—Independent Director | Calle Estrelas 5, 28224 Pozuelo De Alarcon, Madrid, Spain |
| Jean-Paul Prieels | Member—Independent Director | Chemin du Gros Tienne 61, 1380 Lasne, Belgium |
Currently the Audit Committee is counting 2 members. Claudia D'Augusta and Jean-Paul Prieels qualify both in respect of having the necessary competences and qualifications in respect of accounting and audit matters as well as both of the members having an extensive experience in the management of biotech companies.
The Audit Committee will meet at least four times a year and whenever a meeting is deemed necessary or advisable for its proper functioning. Decisions are taken by a majority vote. The Chairman of the Board of Directors has a permanent invitation to attend the meetings of the Audit Committee. The Audit Committee may also invite other persons to attend its meetings.
The Audit Committee meets with the external auditor and the internal auditor (if any) at least twice a year, to discuss matters relating to its terms of reference, issues falling within the powers of the Audit Committee and any issues arising from the audit process and, in particular, any material weaknesses in the internal audit.
During 2020, the Audit Committee met seven times.
The Nomination and Remuneration Committee makes recommendations to the Board of Directors with respect to the appointment of Directors, the Executive Directors and other members of the Executive Committee. In addition, the Nomination and Remuneration Committee makes recommendations to the Board of Directors on the Company's remuneration policy, on any remuneration whatsoever granted to the Directors and members of the Executive Committee and on any agreements or provisions relating to the early termination of employment or collaboration with the Directors and members of the Executive Committee.
The Nomination and Remuneration Committee must ensure in general that the appointment and re-election process of the members of the Board of Directors, the Executive Directors and the members of the Executive Committee is organized objectively and professionally and, in particular and notwithstanding the legal powers of the Board of Directors, has the following duties:
When performing its duties relating to the composition of the Board of Directors, the Nomination and Remuneration Committee takes into account the criteria for the composition of the Board of Directors, as stated in the terms of reference of the Board of Directors.
The Nomination and Remuneration Committee is composed of at least three Directors. All members of the Nomination and Remuneration Committee are Non-Executive Directors, with a majority being independent Directors. The majority of the members has the necessary expertise with regard to remuneration policies, i.e. has a degree in higher education and has at least three years' experience in personnel management matters or matters related to the remuneration of Directors and managers of companies. The Board of Directors considers that all members of the Nomination and Remuneration Committee have sufficient experience in personnel management and matters related to remuneration.
The Nomination and Remuneration Committee is chaired by the chairman of the Board of Directors or by another non-executive member of the Nomination and Remuneration Committee. The chairman of the Board of Directors has a permanent invitation to attend the meetings of the Nomination and Remuneration Committee, except for meetings at which his own appointment, removal or remuneration is discussed. The chairman of the Board of Directors does not chair the Nomination and Remuneration Committee when dealing with the designation of his or her successor.
The duration of the term of a member of the Nomination and Remuneration Committee will not exceed the duration of his mandate as director of the Company.
The following Directors are members of the Nomination and Remuneration Committee:
| Name | Position | Professional address |
|---|---|---|
| Innoste SA, with as permanent representative Jean Stéphenne |
Chairman—Independent Director | Avenue Alexandre 8, 1330 Rixensart, Belgium |
| Castanea Management SARL with as permanent representative Damian Marron |
Member—Independent Director | 401 Chemin du Val Martin, 06560 Valbonne, France |
The Nomination and Remuneration Committee meets at least twice a year, and whenever a meeting is deemed necessary and advisable for its proper functioning. Decisions are taken by a majority vote. The Nomination and Remuneration Committee may invite other persons to attend its meetings (it being understood that a member of the Board of Directors may not attend the meeting of the Nomination and Remuneration Committee which handles his remuneration).
During 2020, the Nomination and Remuneration Committee met five times with particular emphasis on the:
The Board of Directors has established an Executive Committee (the "Executive Committee"), which advises the Board of Directors, and which therefore does not constitute a management committee (comité de direction) under article 7:104 of the Belgian Companies Code and Associations. The terms of reference of the Executive Committee have been determined by the Board of Directors.
The Executive Committee assists the Executive Directors in the management of the Company. The Executive Committee reports to and is accountable to the Board of Directors for the discharge of its responsibilities.
The Executive Committee has the following tasks:
The Executive Committee reports to and is accountable to the Board for the discharge of its responsibilities.
The Executive Directors (CEO and CFO) together with the senior managers (CMO, CBO, CSO and COO) are members of the Executive Committee. The Executive Committee is chaired by the CEO of the Company and in his absence by the CFO. The members of the Executive Committee are appointed and may be dismissed by the Board of Directors at any time. The Board of Directors appoints them on the basis of the recommendations of the Nomination and Remuneration Committee, which also assists the Board of Directors on the remuneration policy for the members of the Executive Committee, as well as their individual remunerations.
The remuneration, duration and the conditions of the resignation of the members of the Executive Committee are governed by the agreements entered into between the Company and each member of the Executive Committee in respect of their function within the Company.
| Name | Title |
|---|---|
| mC4Tx SPRL, represented by Miguel Forte | Chief Executive Officer and Executive Director |
| Finsys Management SPRL, represented by Jean-Luc Vandebroek | Chief Financial Officer and Executive Director |
| Venture Advances Therapies Limited, represented by Stefanos Theoharis |
Chief Business Officer |
| Anthony Ting | Chief Scientific Officer from 1 April 2021 |
| Sven Kili Consulting Ltd, represented by Sven Kili | Interim Chief Medical Officer from 15 January 2021 |
| Anne-Sophie Lebrun | Chief Operations Officer from 1 August 2020 |
The current members of the Executive Committee are listed in the table below:
• mC4Tx SRL, represented by Mr. Miguel Forte, (61) (CEO). Dr. Forte has significant experience in regenerative medicine and in the cell therapy industry, most recently as Chief Executive Officer of Zelluna Immunotherapy, a biopharma company focusing on developing transformative T cell receptors (TCR) based cellular immunotherapies for the treatment of cancers. He is currently also serving as Chief Commercialization Officer and Chair of the Commercialization Committee of the International Society of Cellular Therapy (ISCT).
Dr. Forte held in the past a senior position at the European Medicines Agency (EMA), was Vice-President Global Medical Affairs Inflammation at UCB, Chief Medical Officer (CMO) at TxCell, a cellular therapy company, where he played a key role in TxCell's 2014 IPO, and served as Chief Medical Officer of Bone Therapeutics in 2017. In this last position, Dr. Forte was responsible for the Company's clinical development strategy and advancing its products towards the market. He played a key role in increasing the visibility of the Company throughout the medical community.
With over 20 years professional activity in Clinical, Academic and Pharmaceutical Industry environments with deep experience in the management of operational and strategic functions across Research & Development, Manufacturing, Medical and General Management, Dr. Forte is a recognized leader in the regenerative medicine field who has gained broad expertise in medical and regulatory affairs and commercialization, leading early and late stage clinical trials to market authorization and the launch of new biologic products for various indications.
Dr. Forte graduated in Medicine from the University of Lisbon, specializing in infectious diseases. He then obtained a PhD in Immunology at the University of Birmingham. He is a Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians, UK and Associate Professor in Health Sciences and Pharmacy at the University of Lisbon.
• Finsys Management SRL, represented by Mr. Jean-Luc Vandebroek, (49) (CFO). Jean-Luc Vandebroek is a seasoned finance executive with extensive international finance experience at major public and privately-owned companies. Jean-Luc has built a successful career spanning 15 years at the Belgian-US retailer, Delhaize Group (now Ahold Delhaize). During this period, he held various senior financial positions with increasing responsibility, including roles as Corporate Director Finance Europe and US and Vice President Finance BeLux. He later became Group Chief Financial Officer at Fluxys, a listed, pan-European gas infrastructure group, where he was responsible for the financing of large infrastructure investments using diverse forms of funding on capital markets. Prior to joining Bone Therapeutics, Jean-Luc served as Director and Chief Financial Officer of Moteo Two Wheels and Bihr Europe, the motorcycle division of Alcopa Group, a Belgian family holding with an annual revenue of around EUR 1.7 billion.
The Executive Committee meets regularly whenever it is required for its proper functioning.
The CEO and the CFO have been appointed as Executive Directors of the Company and can be removed by the Board of Directors of the Company. The CEO and the CFO are entrusted by the Board of Directors with the day-to-day management of the Company.
The role of the Executive Directors & Executive Committee is to develop and maintain adequate control system to assure:
The Audit Committee has guiding, supervisory and monitoring role with respect to the Executive Directors & Executive Committee, as regards the development, maintenance and execution of internal controls and:
No internal audit role has been assigned at this point in time as the size of the business does not justify a permanent role in this respect—typical internal audit activities will be outsourced from time to time whereby the Audit Committee will determine frequency of these audits and select topics to be addressed.
The Company took measures to improve the controls and the efficiency of the payment process and implemented tools to allow for a more detailed budget follow-up.
Based on observations made by the external auditors in respect of payroll process, the recoverable cash advances process, the expenditure process and the process for capitalization of the R&D costs, an action plan was established for implementation in the course of 2016.
A new budgeting process was implemented. Each department was asked to provide a separate budget which were subsequently integrated into a global company budget. The new budgeting procedure was designed to provide a stronger involvement to the departments of the Company providing a more accurate forecast of the spending on a more granular level. A monthly reporting of the actual spending was also installed such that each department could follow their spending compared to their budgets creating an additional level of cost awareness.
The Company also improved its ERP with the integration of the new ERP system for the formalization of the purchase orders and the approval of the orders and the invoices.
Investing in securities involves a high degree of risk. Any prospective investor should carefully consider the following risks and all other information contained in the Prospectus before making an investment decision regarding the Company's securities. The risks and uncertainties described below are significant risk factors, currently known and specific to the Company, which the Company believes are relevant for an investment in its securities. If any of these risks actually occurs, the business, financial condition or results of operations of the Company would likely be materially and/or adversely affected. In such case, the price of the securities could decline, and an investor could lose all or part of its investment. These risks and uncertainties include the following:
Research programs and product candidates of the Company must undergo rigorous preclinical tests and clinical trials, of which the start, timing of completion, number and results are uncertain and could substantially delay or prevent the products from reaching the market. Clinical trials may be delayed for a variety of reasons, including, but not limited to, delays in obtaining regulatory approval to commence a trial, in reaching agreement on acceptable terms with prospective clinical research organizations, contract manufacturing organizations and clinical trial sites, in obtaining approval of the Competent Authority, in recruiting suitable patients to participate in a trial, in having patients complete a trial, in obtaining sufficient supplies of clinical trial materials or clinical sites dropping out of a trial and in the availability to the Company of appropriate clinical trial insurances. In particular, the clinical trials related to orthopedics require longer follow-up periods of up to 24 months.
development or, if approved by the Competent Authorities, after the approved product has been commercialized.
• Failure to successfully identify, develop and commercialize additional products or product candidates could impair the Company's ability to grow.
• Fluctuation in interest rates could affect the Group's results and financial position.
Certain significant shareholders of the Company after the Offering may have different interests from the Company and may be able to control the Company, including the outcome of shareholder votes.
The Company manages liquidity risk by continuously monitoring forecast and actual cash flows, and by matching the maturity profiles of financial assets and liabilities.
The Company's main sources of cash inflows at current are obtained through capital increases, subsidies, government loans and where appropriate loans from commercial banks to finance long-term requirements (investment in infrastructure). A key objective of the Board together with the Executive Directors is to ensure that the Company remains adequately financed to meet its immediate and medium-term needs.
If necessary and appropriate, the Company assures itself of short-term borrowing facilities to cover short-term cash requirements.
The Company has limited interest rate risk on long-term loans granted by regional investment bodies but also including the turnover independent reimbursements (30%) related to RCA's concluded as of 2009 are carrying fixed interest rates. The group at current does not undertake any hedging.
The Company believes that its credit risk, relating to receivables, is limited because currently almost all of its receivables are with public institutions. Cash and cash equivalent and short-term deposits are invested with highly reputable banks and financial institutions.
The maximum credit risk, to which the Group is theoretically exposed as at the balance sheet date, is the carrying amount of the financial assets. At the end of the reporting period no financial assets were past due, consequently no financial assets were subject to impairment.
The Company is currently not exposed to any significant foreign currency risk.
However, should the Company enter into long-term collaboration agreements with third parties for which revenues would be expressed in a foreign currency, the Company might in such case consider entering into a hedging arrangement to cover such currency exposure (in case the related expenditure is planned in local currency). The Company will also monitor exposure in this respect following the establishment of its US subsidiary. At current, there is no significant exposure in USD.
Within the Board of Directors, an annual strategy meeting is organized:
The Executive Directors develop a long-term financial plan (at least 3 years looking forward) incorporating the strategy decided upon—this plan is updated on a regular basis to keep it in line with the strategy plans.
The Executive Directors develop an annual budget which is approved by the board and which is closely monitored during the year. Deviations are reported to the board and corrective action is taken when necessary.
The Company has implemented an ERP system in support of its financial and logistics management. This system will be evaluated at regular intervals in how far it meets the needs of the organization. Where and when necessary, the system will be further upgraded to address new needs or to strengthen controls.
In general supervision and monitoring of the operations of the Company is done on a permanent/daily basis at all levels within the Company. As a general policy, deviations are reported at all times to the supervisory level.
In its Governance Charter, the Company established several rules to prevent illegal use of inside information by Directors, shareholders, management members and employees, or the appearance of such use.
These prohibitive provisions and the monitoring of compliance with them are primarily intended to protect the market. Insider dealing attacks the very essence of the market. If insiders are given the opportunity to make profits on the basis of inside information (or even if the mere impression thereof is created), investors will turn their back on the market. A decreased interest may affect the liquidity of listed shares and prevents optimal company financing.
An insider can be given access to inside information within the scope of the normal performance of his duties. The insider has the strict obligation to treat this information confidentially and is not allowed to trade financial instruments of the Company to which this inside information relates.
The Company keeps a list of all persons (employees or persons otherwise working for the Company) having (had) access, on a regular or occasional basis, to inside information. The Company will regularly update this list and transmit it to the FSMA whenever the FSMA requests the Company to do so.
The Company complies with the new law of 28 April 2020. This new law combines new rules that have been introduced in Belgian company law, implementing the EU Directive 2017/828 as regards the encouragement of long-term shareholder engagement.
The Nomination and Remuneration Committee (or Remco), set up by the Board, is responsible for outlining a remuneration policy for the Executive and Non-Executive Directors.
Board members are remunerated based on a benchmarking exercise done on a regular basis by the Remco with other peer companies to ensure that this remuneration is fair, reasonable and competitive and is sufficient to attract, retain and motivate the Directors of the Company. In this respect the Remco and the Board shared the view that all board members independent and non-independent should be compensated equally with a fixed compensation. For the chairman and the chairs of the committees the board proposed a supplementary compensation.
Without prejudice to the powers granted by law to the shareholders meeting, the Board of Directors may set and revise at regular intervals the rules and the level of compensation for its Directors.
The remuneration of the Executive Directors and the remuneration of the members of the Executive Committee are determined by the Board of Directors on recommendations made by the Nomination and Remuneration Committee, further to recommendations made by the Executive Directors (except where their own remuneration is concerned). The Company strives to offer a competitive remuneration within the sector.
The remuneration of the Directors is determined by the shareholders' meeting upon proposal of the Board of Directors on the basis of the recommendations made by the Nomination and Remuneration Committee. The following remuneration policy is in place for the Non-Executive Directors' remuneration.
The Non-Executive Directors received a fixed remuneration in consideration for their membership of the Board of Directors and their membership of the Committees.
The Nomination and Remuneration Committee recommends the level of remuneration for Non-Executive Directors, subject to approval by the Board of Directors and, subsequently, by the shareholders' meeting. The Nomination and Remuneration Committee benchmarks Directors' compensation against peer companies to ensure that it is competitive. Remuneration is linked to the time committed to the Board of Directors and its various committees.
The shareholders' meeting decides to maintain the resolution approved in 2016 concerning the remuneration of the non-executive Directors, as follows: a fixed annual remuneration for the members of the Board of Directors of €20,000; an additional annual remuneration for the Chairman of the Board of Directors of €20,000; and an additional annual remuneration for membership of each committee of the Board of Directors of €5,000 for committee members and €10,000 for the chairman of the committee.
The shareholders' meeting also decides to approve the proposal of the Company's Nomination and Remuneration Committee to grant each year: 6,666 subscription rights to the Chairman of the Board of Directors; 1,000 subscription rights to each non-executive Director of the Company; 500 subscription rights to each committee or sub-committee Chairman; as well as 500 additional subscription rights to any Director in charge of a special mandate within the Board of Directors. The shareholders' meeting confirms that the granting of subscription rights cannot be considered as variable remuneration. Any changes to these fees will be submitted to the shareholders' meeting for approval. The Executive Directors will not receive any specific remuneration in consideration for their membership of the Board of Directors.
| Fixed Remuneration (€) | Variable Remuneration (€) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Name, Position | Base compensation |
Attendance fees |
Other benefits |
One year variable |
Multi year variable |
Extra ordinary items (€) |
Pension expense (€) |
Total remu neration (€) |
Fixed | Variable |
| Innoste S.A., with as permanent representative Jean Stéphenne |
50,000 | / | / | / | / | / | / | 50,000 100% | 0% | |
| Claudia D'Augusta | 30,000 | / | / | / | / | / | / | 30,000 100% | 0% | |
| Castanea Management SARL with as permanent representative Damian Marron |
25,000 | / | / | / | / | / | / | 25,000 100% | 0% | |
| Jean-Paul Prieels | 25,000 | / | / | / | / | / | / | 25,000 100% | 0% | |
| ClearSteer Consulting LLC with permanent representative Gloria Matthews |
20,000 | / | / | / | / | / | / | 20,000 100% | 0% | |
| Total | 150,000 | / | / | / | / | / | / | 150,000 | 100% | 0% |
The total remuneration for the Non-Executive Directors for 2020 amounts to €150,000. The table below provides an overview of the remuneration per Independent Directors.
All Directors will be entitled to a reimbursement of out-of-pocket expenses actually incurred as a result of participation in meetings of the Board of Directors.
There are no loans outstanding from the Company to the members of the Board of Directors. There are no employment or service agreements that provide for notice periods or indemnities between the Company and Non-Executive Directors.
Also, any agreement, entered or extended on or after 3 May 2010, between the Company and a Non-Executive Director, which would provide for a variable remuneration, must be submitted for approval to the next annual shareholders' meeting.
The table below provides an overview of significant positions of shares held directly or indirectly on 31 December 2020 by the Non-Executive Members of the Board of Directors. The overview must be read together with the notes referred to below.
| Shares | |||||
|---|---|---|---|---|---|
| Non-Executive Directors | Number | %* | |||
| Innoste S.A., with as permanent representative Jean Stéphenne | 47,038 | 0.28% | |||
| * calculated as the percentage of all outstanding shares and warrants (16,711,055 which is 16,478,168 shares and 232,887 warrants) at the date of the Document |
The table below provides an overview of the main condition of the warrant plans as well as information related to the financial year 2020 regarding Non-Executive Members of the Board of Directors:
| Main condition of the warrant plans | Information related to the financial year 2020 | |||||||
|---|---|---|---|---|---|---|---|---|
| Name Position4 |
Plan ID | Grant date | Vesting Date | Retention period |
Exercise period |
A) Number of options vested; B) Value at exercise price (€) |
A) Number of options exercised ; B) Date of exercise |
Number of options expired |
| Jean Stéphenne, Chairman |
Plan A | 28-02-19 | 1/3 at 28-02-2020 2/3 at 28-02-2021 3/3 at 28-02-2022 |
- | 28-02-2019 - 28/02/2029 |
A) 6,666 B) 4.11 |
- | - |
| Jean Stéphenne, Chairman |
Plan 2020 |
23-12-20 | 23-12-20 | - | 24/12/2023 - 23/12/2027 |
A) 14,332 B) 2.74 |
- | - |
| Claudia D'Augusta, Director |
Plan 2020 |
23-12-20 | 23-12-20 | - | 24/12/2023 - 23/12/2027 |
A) 3,000 B) 2.74 |
- | - |
| Jean-Paul Prieels, Director |
Plan 2020 |
23-12-20 | 23-12-20 | - | 24/12/2023 - 23/12/2027 |
A) 3,000 B) 2.74 |
- | - |
| Damian Marron, Director |
Plan A | 28-02-19 | 1/3 at 28-02-2020 2/3 at 28-02-2021 3/3 at 28-02-2022 |
- | 28-02-2019 - 28/02/2029 |
A) 666 B) 4.11 |
- | - |
| Damian Marron, Director |
Plan 2020 |
23-12-20 | 23-12-20 | - | 24/12/2023 - 23/12/2027 |
A) 2,000 B) 2.74 |
- | - |
| Gloria Matthews, Director |
Plan 2020 |
23-12-20 | 23-12-20 | - | 24/12/2023 - 23/12/2027 |
A) 2,000 B) 2.74 |
- | - |
4 Please note that the warrants have been offered to the Company of the representative named in the table, which is the case for Jean Stéphenne, Damian Marron and Gloria Matthews
The remuneration package applicable in 2020 for the Executive Directors and the members of the Executive Committee is in line with the remuneration levels in comparable companies for these functions.
The key components of this policy can be summarized as follows:
| Performance factor | Weight |
|---|---|
| Financial (cash position end of year, budget management, funding strategy development) |
35% |
| Business development & Commercialization strategy development (commercial deal, scientific partnership) |
30% |
| Clinical trials progress (recruitment timelines, sites initiations and activations) |
25% |
| Regulatory Strategy development | 10% |
5 February 2015). Article 7:91 stipulates that: "Unless otherwise provided for in the articles of association or expressly approved by the general meeting, at least one quarter of the variable remuneration of an Executive Director in a listed company must be based on predetermined and objectively measurable performance criteria over a period of at least two years, and another quarter must be based on predetermined and objectively measurable criteria over a period of at least three years.
In accordance with Article 3:6 of the Belgian Code of Companies and Associations, this remuneration report includes the amount of the remuneration of, and any other benefits granted to, the Company's CEO, on a broken-down basis.
| Fixed Remuneration (€) | Variable Remuneration (€) |
Extra | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Name, Position |
Base compensation |
Administrator compensation |
Other benefits |
One-year variable |
Multi year variable |
ordinar y items (€) |
Pension expense (€) |
Total remu neration (€) |
Fixed | Variable |
| Miguel Forte, CEO |
300,000 | / | 19,900 | 112,500 | / | / | / | 432,000 | 74% | 26% |
Other benefits include transportation repayments and phone bills repayments.
The one-year variable is a bonus based on key performance indicators stated above. The maximum variable remuneration is set at [50% * base salary] for the CEO. For the year 2020, the CEO performance was set at 75%.
Following his resignation as CEO it was agreed that Thomas Lienard will continue to provide support to the company until 17 June 2020. For these services, a total amount of €134,610 has been paid of the period 1 January 2020 until 17 June 2020.
In accordance with Article 3:6 of the Belgian Code of Companies and Associations, this remuneration report also includes the amount of the remuneration of, and any other benefits granted to, the Company's other Members of the Executive Committee, on a broken-down basis.
The Executive Committee (excluding the CEO) in place during 2020 was as follows:
Currently, all members of the Executive Committee (excluding Anne-Sophie Lebrun) are engaged on the basis of a service agreement. The contracts with all members of the Executive Committee can be terminated at any time, subject to certain pre-agreed notice periods not exceeding 12 months, which may, at the discretion of the Company, be replaced by a corresponding compensatory payment.
Please find the amount of remuneration on a broken-down basis for the other Members of the Executive Committee:
| Fixed Remuneration (€) | Variable Remuneration (€) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Name, Position |
Base compensation |
Administrator compensation |
Other benefits |
One-year variable |
Multi year variable |
Extra ordinar y items (€) |
Pension expense (€) |
Total remunera-tion (€) |
Fixed | Variable |
| Other Members of the Executive Committee |
861,000 | / | 46,000 | 153,000 | / | / | / | 1,060,000 | 86% | 14% |
The one-year variable is a bonus based on key performance indicators stated above. The maximum variable remuneration is set between [20% and 30% * base salary] depending on the positions. For the year 2020, the average performance of the Executive Committee (excluding the CEO) was set at 89%.
The table below provides an overview of the main condition of the warrant plans as well as information related to the financial year 2020 regarding members of the Executive Committee:
| Main condition of the warrant plans | Information related to the financial year 2020 | |||||||
|---|---|---|---|---|---|---|---|---|
| Name Position |
Plan ID | Grant date |
Vesting Date | Retention period |
Exercise period |
A) Number of options vested; B) Value at exercise price (€) |
A) Number of options exercised; B) Date of exercise |
Number of options expired |
| Miguel Forte, CEO |
Plan 2020 |
29-05-21 | 29-05-21 | - | 30/05/2023 - 29/05/2027 |
A) 51,724 B) 2.74 |
- | - |
| Miguel Forte, CEO |
Plan 2020 |
23-12-20 | 23-12-20 | - | 24/12/2023 - 23/12/2027 |
A) 58,000 B) 2.55 |
- | - |
| Jean-Luc Vandebroek, CFO |
Plan A | 28-02-19 | 1/3 at 28-02-2020 2/3 at 28-02-2021 3/3 at 28-02-2022 |
- | 28-02-2019 - 28/02/2029 |
A) 24,000 B) 4.11 |
- | - |
| Jean-Luc Vandebroek, CFO |
Plan 2020 |
29-05-21 | 29-05-21 | - | 30/05/2023 - 29/05/2027 |
A) 12,000 B) 2.74 |
- | - |
| Jean-Luc Vandebroek, CFO |
Plan 2020 |
23-12-20 | 23-12-20 | - | 24/12/2023 - 23/12/2027 |
A) 7,500 B) 2.55 |
- | - |
| Olivier Godeaux, CMO |
Plan 2020 |
23-12-20 | 23-12-20 | - | 24/12/2023 - 23/12/2027 |
A) 5,000 B) 2.55 |
- | - |
| Stefanos Theoharis, CBO |
Plan 2020 |
23-12-20 | 23-12-20 | - | 24/12/2023 - 23/12/2027 |
A) 5,000 B) 2.55 |
- | - |
The table below provides an overview of significant positions of shares held directly or indirectly on 31 December 2020 by the other Members of the Executive Committee. The overview must be read together with the notes referred to below.
| Shares | |||||
|---|---|---|---|---|---|
| Executive Committee Member | Number | %* | |||
| Finsys Management SRL | 2,880 | 0.02% | |||
| * calculated as the percentage of all outstanding shares and warrants (16,711,055 which is 16,478,168 shares and 232,887 warrants) at the date of the Document |
• Miguel Forte
The management agreement between mC4Tx SRL and the Company is tacitly renewed on a yearly basis for a maximum of five years. Both the Company and mC4Tx SRL may terminate the management agreement by means of a six months' notice. Moreover, the Company may terminate the management agreement with immediate effect and without payment of any indemnity in the event mC4Tx SRL commits a serious breach of its obligations under the management agreement. mC4Tx SRL may terminate the management agreement with immediate effect in the event the Company commits a serious breach of its obligations under the management agreement, in which case he will receive an indemnity corresponding to six months' fees.
The management agreement also provides for a non-compete clause preventing mC4Tx SRL and Miguel Forte in person from engaging in any activities in the European Union or in the United States that are similar to those being pursued by the Company during the term of the management agreement or for a period of three years after termination of the management agreement.
• Jean-Luc Vandebroek
The management agreement between Finsys Management SRL and the Company is tacitly renewed on a yearly basis for a maximum of five years. Both the Company and Finsys Management SRL may terminate the management agreement by means of a six months' notice. Moreover, the Company may terminate the management agreement with immediate effect and without payment of any indemnity in the event Finsys Management SRL commits a serious breach of its obligations under the management agreement. Finsys Management SRL may terminate the management agreement with immediate effect in the event the Company commits a serious breach of its obligations under the management agreement, in which case he will receive an indemnity corresponding to six months' fees. In addition, in the event of a change of control of the Company, the Company must pay an indemnity corresponding to a year's fees to Finsys Management SRL if the management agreement is terminated within the year of the change of control, unless Finsys Management SRL commits a serious breach of its obligations under the management agreement. This change of control indemnity will also be due in the event the services to be procured by Finsys Management SRL under the management agreement are unilaterally and materially reduced within two years of the change of control and if Finsys Management SRL terminates the management agreement because of this reduction.
The management agreement also provides for a non-compete clause preventing Finsys Management SRL and Jean-Luc Vandebroek in person from engaging in any activities in the European Union or in the United States that are similar to those being pursued by the Company during the term of the management agreement or for a period of three years after termination of the management agreement.
• Stefanos Theoharis
The management agreement between Venture Advances Therapies Limited and the Company is tacitly renewed on a yearly basis for a maximum of five years. Both the Company and Venture Advances Therapies Limited may terminate the management agreement by means of a three months' notice. Moreover, the Company may terminate the management agreement with immediate effect and without payment of any indemnity in the event Venture Advances Therapies Limited commits a serious breach of its obligations under the management agreement. Venture Advances Therapies Limited may terminate the management agreement with immediate effect in the event the Company commits a serious breach of its obligations under the management agreement, in which case she will receive an indemnity corresponding to six months' fees.
The management agreement also provides for a non-compete clause preventing Venture Advances Therapies Limited and Stefanos Theoharis in person from engaging in any activities in the European Union or in the United States that are similar to those being pursued by the Company during the term of the management agreement or for a period of three years after termination of the management agreement.
• Olivier Godeaux
The management agreement between ZAM Consulting SRL and the Company is tacitly renewed on a yearly basis for a maximum of five years. Both the Company and ZAM Consulting SRL may terminate the management agreement by means of a three months' notice. Moreover, the Company may terminate the management agreement with immediate effect and without payment of any indemnity in the event ZAM Consulting SRL commits a serious breach of its obligations under the management agreement. ZAM Consulting SRL may terminate the management agreement with immediate effect in the event the Company commits a serious breach of its obligations under the management agreement, in which case she will receive an indemnity corresponding to six months' fees.
The management agreement also provides for a non-compete clause preventing ZAM Consulting SRL and Olivier Godeaux in person from engaging in any activities in the European Union or in the United States that are similar to those being pursued by the Company during the term of the management agreement or for a period of three years after termination of the management agreement.
• Anthony Ting
Anthony Ting has an employment contract with the affiliate in US. In the event of termination of the employment contract, the legal provisions of the American law apply.
• Anne-Sophie Lebrun
Anne-Sophie Lebrun has an employment contract with the Company. In the event of termination of the employment contract, the legal provisions of Belgian law apply.
The table below includes the evolution of the Remuneration of Non-Executive Directors, Remuneration of CEO, Remuneration of Core Leadership Team, Company performance and the average remuneration per FTE employee for last 5 years:
| 2016 | 2017 | 2018 | 2019 | 2020 | |
|---|---|---|---|---|---|
| Remuneration of Non-Executive Directors |
|||||
| Total annual remuneration (€) | 205,000 | 223,490 | 227,500 | 172,500 | 150,000 |
| Year-on-year difference | / | 9% | 2% | -24% | -13% |
| Number of Non-Executive Directors under review |
9 | 12 | 12 | 7 | 5 |
| Remuneration of CEO | |||||
| Total annual remuneration (€) | 223,000 | 281,000 | 355,000 | 328,000 | 432,000 |
| Year-on-year difference | / | 26% | 26% | -8% | 32% |
| Remuneration of CLT | |||||
| Total annual remuneration (€) | 1,111,000 | 1,047,000 | 963,000 | 1,056,000 | 1,060,000 |
| Year-on-year difference | / | -6% | -8% | 10% | 0% |
| Number of CLT Members under review | 6 | 7 | 6 | 7 | 6 |
| Company performance (thousands of euros) | |||||
| Net profit/(loss) for the period | (13) | (11,9) | (14,1) | (10,3) | (11,9) |
| Cash position at the end of year | 20,3 | 8,4 | 8,1 | 8,6 | 14,6 |
| Average remuneration per FTE employee | |||||
| Average employee cost per FTE | 67,249 | 68,990 | 72,151 | 75,493 | 84,879 |
| Year-on-year difference | / | 3% | 5% | 5% | 12% |
The Table below shows a comparison of the 2020 total remuneration of the CEO (in €), to the 2020 remuneration of the lowest paid full time Bone Therapeutics SA employee (in €). The remuneration includes fixed and variable remuneration as well as employee benefits, excluding employer social security charges.
| 2020 | |
|---|---|
| Ratio of Total Remuneration of CEO versus Lowest Remunerated Employee |
1:11 |
There are no provisions allowing the Company to reclaim any variable remuneration paid to the CEO or the other—members of the Executive Committee.
Each member of the Executive Committee and each Director needs to focus to arrange his or her personal business to avoid direct and indirect conflicts of interest with the Company. The Company's corporate governance charter contains specific procedures when potential conflicts could appear.
There is a conflict of interest when the administrator has a direct or indirect financial interest adverse to that of the Company. In accordance with Article 7:96 of the Belgian Code on Companies and Associations, a director of a limited company which "has, directly or indirectly, an interest of an economic nature in a decision or an operation under the Board of Directors" is held to follow a particular procedure. If members of the Board, or of the Executive Committee or their permanent representatives are confronted with possible conflicting interests arising from a decision or transaction of the Company, they must inform the Chairman of the Board thereof as soon as possible. Conflicting interests include conflicting proprietary interests, functional or political interests or interests involving family members (up to the second degree).
If Article 7:96 of the Belgian Code on Companies and Associations is applicable, the Board member involved must abstain from participating in the deliberations and in the voting regarding the agenda items affected by such conflict of interest. Below is an overview of the meetings of the Board of Directors in which the conflictof-interest procedure has been applied.
Prior to discussing the items on the agenda, the Board acknowledged that, in accordance with Article 7:96 of the Code on Companies and Associations:
• mC4Tx SPRL, represented by Mr Miguel Forte and Finsys Management SPRL, represented by Mr Jean-Luc Vandebroek, directors of the Company, declares having a direct or indirect financial interest, conflicting with certain decisions that fall within the scope of the powers of the board of directors, in particular with respect to item 8 of the agenda as it concerns the discussions relating to the HR structure of the Company and the approval of the recommendations of the Nomination and Remuneration Committee (NRC) regarding the bonus plan for 2019 and the objectives for 2020.
These board members were present at the meeting but did not take part in any deliberation and resolutions where they had a conflict of interest.
The other directors of the Company present as aforementioned, each declared not to have any direct or indirect financial interest conflicting with the decisions to be taken.
The Board believes that the discussions regarding the evaluation of the performance in 2019 and the determination of the objectives for 2020 are in line with the strategic orientation of the Company and are in the interest of the Company.
The exact financial impact of the decision on the Company are summarized in the financial package of the directors.
Assessment of 2019 objectives and 2020 objectives:
The Nomination and Remuneration Committee ("NRC") presents the objectives 2020 for the CEO. The Board shall review and approve the finalised version once circulated by the CEO.
Regarding the 2019 objectives, and based on the recommendations of the NRC, the Board decides that:
Regarding the stock option plan, the Board decides to approve the preparation of a plan to be attributed to the CEO and the CFO in accordance with and under the proportions set out in the previous commitments of the Company in that regard.
Prior to discussing the items on the agenda, the board of directors acknowledged that, in accordance with Article 7:96 of the Code on Companies and Associations:
The Board believes that the grant of SOP incentivises the CEO and CFO and is therefore in the interest of the Company.
In accordance with Article 7:96 of the Code on Companies and Associations, the auditor of the Company, Deloitte Réviseurs d'Entreprises SC SRL, represented by Julie Delforge, shall receive a copy of the Board minutes and the extract of these minutes relating to the conflict of interests will be added in the annual report of the directors in relation to the financial year ending 31 December 2020 of the Company.
These board members are present at the meeting, but do not take part in the deliberation or resolutions in respect of which they have a conflict of interest.
The other directors of the Company, present as aforementioned, each declare not to have any direct or indirect financial interest conflicting with the decisions to be taken.
The Board noted the terms and conditions of the SOP Plan 2020, a copy of which was circulated to the Board prior to the meeting, and APPROVED the SOP Plan 2020, subject to the finalisation thereof.
Upon recommendation of the Nomination and Remuneration Committee and as suggested on 18 December 2019, the Board RESOLVED to grant subscription rights ("SOP") subject to the terms and conditions of the SOP Plan 2020 to the following persons and in the following proportions:
| Beneficiary | Number of SOP to be granted |
Date of offer |
|---|---|---|
| mC4Tx SRL, represented by Mr Miguel Forte (CEO) |
51,724 | May 2020 |
| Finsys Management SRL, represented by Mr Jean Luc Vandebroek (CFO) |
12,000 | May 2020 |
| TOTAL | 63,724 |
This grant of SOP shall be done in the framework of the authorised capital of the Company on the basis of the authorisation of 0.6% (+/- 65,000 SOP) approved in the 2019 General Assembly and shall be considered as fixed compensation.
Notwithstanding Article 5.6 of the SOP Plan 2020, the Board RESOLVED that the SOP granted to mC4Tx SRL and Finsys Management SRL may be transferred to the directors of these companies representing them in the execution of the services provided by these companies to Bone Therapeutics. Any other inter vivos transfer of SOP covered by Article 5.6 of the SOP Plan 2020, including the transfer from a natural person to another beneficiary remains excluded.
The decision of the Board to (i) grant the SOP to mCT4x SRL and Finsys Management SRL under the proportions and conditions set out above and (ii) allow the transfer of the SOP granted to mC4Tx SRL and Finsys Management SRL to the directors of these companies representing them in the execution of the services provided by these companies to the Company is subject to the effective issuance of the SOP.
The Board APPROVED the execution of the SOP Plan 2020, subject to the finalisation of the documentation, including:
Subject to the recommendation of the Nomination and Remuneration Committee, the Board granted power to Mr Miguel Forte and Mr Jean-Luc Vandebroek to finalise, amend and sign the documentation of the Board in the name and on behalf of the Board including the signature of the deed at the notary.
The directors of the Company, present as aforementioned, each declared not to have any direct or indirect financial interests conflicting with the decisions to be taken. Except for Finsys Management represented by Jean-Luc Vandebroek.
Finsys Management SRL, represented by Mr Jean-Luc Vandebroek, director of the Company, declares having a direct or indirect financial interest, conflicting with certain decisions that fall within the scope of the powers of the board of directors, in particular with respect to item 3 of the agenda as it concerns the approval of the grant of SOP to Finsys Management SRL, represented by Mr Jean-Luc Vandebroek and being the CFO of the Company, in the framework of the authorised capital on the basis of the authorisation of 0.6% approved in the 2020 General Assembly.
The Board believes that the grant of SOP incentivises the CFO and is therefore in the interest of the Company.
The Board discussed the proposal of the RemCo of 25 August 2020 for allocating warrants under the SOP plan as approved by the shareholders' meeting on 10 June 2020. It was proposed to issue and allocate 99,832 warrants as follows:
The Board decided unanimously to grant and allocate the warrants as recommended by RemCo, which is in line with the authorisation given by the shareholders' meeting on 10 June 2020.
The Board furthermore decided unanimously that the offer date of the warrants will be the 10th day after completion of the equity raise. The warrants will be issued in the framework of the authorised capital of the Company, as authorised by the shareholders' meeting in 2020. The board therefore decided to request mC4Tx SRL, represented by Mr Miguel Forte and Finsys Management SRL, represented by Mr Jean-Luc Vandebroek to finalise the draft board reports relating to the issuance of the warrants and the cancellation of the preferential subscription right and to take any other actions that are required or useful for the issuance and offer of the new warrants.
The Board furthermore decided to grant a special power of attorney to Mr Miguel Forte and Finsys Management SRL, represented by Mr Jean-Luc Vandebroek to sign all necessary reports, deeds, agreements and other documents (including the draft board reports and the notarial deed) to complete the allocation and issue of the warrants, and the effective offer thereof to the beneficiaries.
Currently, as far as the Company is aware, none of the other members of the Board of Directors have a conflict of interest within the meaning of Article 7:96 of the Belgian Companies and Associations Code that has not been disclosed to the Board of Directors. Other than potential conflicts arising in respect of compensationrelated matters, the Company does not foresee any other potential conflicts of interest in the near future.
The Company has granted SCTS personal, non-transferable royalty-free licenses to use, perform, research, develop and manufacture products in the name of the Company. A first license is granted by the Company to SCTS over the technology claimed by the ULB-028 patent family, in the framework of the PROFAB and EXCIP agreements entered into by the Company and SCTS (i.e. a research and development agreement between the Company, SCTS and the Region). A second license is granted by the Company to SCTS over the technology claimed by the BPBONE-001 and 002 patent families in the framework of the JTA PROD agreement (i.e. also a research and development agreement between the Company, SCTS and the Region). A third license is granted by the Company to SCTS over the technology claimed by the BONE-001 patent family; in the framework of the MO SELECT, CRYOFIN, PROSTERIL and ALLOPROD agreements (i.e. also a research and development agreement between the Company, SCTS and the Region).
As from 28 October 2020, all the recoverable cash advances conventions of SCTS have been transferred to Bone Therapeutics SA with the approval of the DGO6, the department in charge of grants & subsidies at the Walloon Region.
As the Company and SCTS operated together closely whereby both companies are occupying the same building (owned by SCTS) and staff employed by SCTS is operating under a consultancy arrangement on administrative and research projects for the account of Bone Therapeutics, agreements have been put in place to govern this relation and a VAT grouping was established between the two companies (effective as of 1 January 2016). All those agreements have been terminated at the signature of the sale of SCTS to Catalent Gosselies SA.
In course of 2020, expenses related to all activities executed through Bone Therapeutics USA Inc. have been re-invoiced to the Company on 31 December 2020.
As a result of the relationship of the government (i.e. Walloon Region) with some shareholders of the Company and the extent of financing received, the Company judges that the government is a related party. However, the principal amounts recognized in the financial statements relate to government grants for a total of €35.54 million (2019: €33.15 million). Next to the government grants, government agencies granted loans to the Group for a total amount of € 3.97 million (€ 2.42 million in 2019).
There were no transactions with the Executive Committee in 2020.
For information on the Executive Committee remuneration, see Section 4.7.2.2 "Remuneration of the CEO and the other Executive Directors and the Executive Committee".
Article 7:97 of the Belgian Code on Companies and Associations provides for a special procedure which must be followed for transactions with Bone Therapeutics' affiliated companies or subsidiaries. Such a procedure does not apply to decisions or transactions that are entered into the ordinary course of business at usual market conditions or for decisions and transactions whose value does not exceed one percent of the Companies' consolidated net assets.
At the date of 31 December 2020, the Company's capital amounts to €8,414,913.01, represented by 16,478,168 ordinary shares without nominal value.
On 31 December 2020, 232,887 warrants were attributed and are still in circulation.
On 5 February 2015, the share capital was increased by a contribution in cash further to the completion of the initial public offering of the Company, in the amount of €6,077,750 with issuance of 2,012,500 shares. The new shares were issued at a price of €16 per share (of which 3.02 in share capital and 12.98 in issuance premium). The aggregate issuance premium amounted to €26,122,250.00. Following the capital increase, the share capital of the Company amounted to €16,544,052.63 and was represented by 5,470,740 shares.
On the same day, the share capital was increased by a contribution in cash further to the conversion of the convertible bonds, in the amount of €3,252,657.78 with issuance of 1,077,039 shares. The new shares were issued at a price of €9.61 per share (of which 3.02 in share capital and 6.59 issuance premium). The aggregate issuance premium amounted to €7,097,342.22. Following the capital increase, the share capital of the Company amounted to €19,796,710.41 and was represented by 6,547,779 shares.
On 11 February 2015, the share capital was increased by contribution in cash further to the exercise of the over-allotment subscription right, in the amount of €911,662.50 with issuance of 301,875 shares. The new shares were issued at a price of €16 per share (of which 3.02 in share capital and 12.98 in issuance premium). The aggregate issuance premium amounted to €3,918,337.50. Following the capital increase, the share capital of the Company amounted to €20,708,372.90, represented by 6,849,654 shares.
On 30 October 2017, the share capital was decreased by an incorporation of losses of an amount of €6,045,571.41 without any reduction of shares.
On 7 March 2018, a total amount of €19.45 million in committed capital has been subscribed.
On 9 March 2018, as a result of the exercise of bond warrants and the conversion of the convertible bonds placed via a private placement on 7 March 2018, the share capital was increased by €1,210,754 with issuance of 565,773 shares. The aggregate share premium for this transaction amounts to €4,791,588.
From April 2018 to June 2018, as a result of the conversion of the convertible bonds placed via a private placement on 7 March 2018, the share capital was increased by €464,215 with issuance of 216,923 shares. The aggregate share premium for this transaction amounts to €1,413,251.
On 9 July 2018, the share capital was decreased by an incorporation of losses of an amount of €4,830,335.13 without any reduction of shares.
From July 2018 to December 2018, as a result of the conversion of the convertible bonds placed via a private placement on 7 March 2018, the share capital was increased by €1,024,076 with issuance of 678,196 shares. The aggregate share premium for this transaction amounts to €4,608,258.
From January 2019 to June 2019, as a result of the conversion of the convertible bonds placed via a private placement on 7 March 2018, the share capital was increased by €968,552 with issuance of 641,425 shares. The aggregate share premium for this transaction amounts to € 1,313,907.
Via the Private Placement on 27 June 2019, the Company has raised EUR 5.0 million and placed 1,351,352 new shares with current and new institutional investors in Belgium. The share capital was increased by €2,040,542. The aggregate share premium for this transaction amounts to €2,959,458. Following the capital increase, the share capital of the Company amounted to €15,540,605 and was represented by 10,303,323 shares.
From July 2019 till 12 December 2019, as a result of the conversion of the convertible bonds placed via a private placement on 7 March 2018, the share capital was increased by €479,218 with issuance of 317,363 shares and amounts to €16,019,823.16 and is represented by 10,620,686 shares. The aggregate share premium for this transaction amounts to €595,732.
On 12 December 2019, the Company decided to reduce its share capital by the incorporation of the losses. After the operation the share capital amounts to €5,427,597.19.
On 18 December 2019, as a result of the conversion of the convertible bonds placed via a private placement on 7 March 2018, the share capital was increased by €26,116.08 with issuance of 51,208 shares. The aggregate share premium for this transaction amounts to €136,378.31.
On 29 January 2020, as a result of the conversion of the convertible bonds placed via a private placement on 7 March 2018, the share capital was increased by €80,699.85 with issuance of 158,235 shares. The aggregate share premium for this transaction amounts to €451,774.60.
On 26 February 2020, as a result of the conversion of the convertible bonds placed via a private placement on 7 March 2018, the share capital was increased by €61,311.18 with issuance of 120,218 shares. The aggregate share premium for this transaction amounts to €393,671.85.
On 25 March 2020, as a result of the conversion of the convertible bonds placed via a private placement on 7 March 2018, the share capital was increased by €79,592.64 with issuance of 156,064 shares. The aggregate share premium for this transaction amounts to €320,397.19.
On 30 April 2020, as a result of the immediate conversion of the convertible bonds placed via a private placement announced on 29 April 2020, the share capital was increased by € 203,302.32 with issuance of 398,632 shares. The aggregate share premium for this transaction amounts to € 796,697.15..
On 7 May 2020, as a result of the conversion of the convertible bonds placed via a private placement on 7 March 2018, the share capital was increased by € 80,629.47 with issuance of 158,097 shares. The aggregate share premium for this transaction amounts to € 306,864.56.
On 21 August 2020, as a result of the conversion of the convertible bonds placed via a private placement announced on 29 April 2020, the share capital was increased by € 100,332.81 with issuance of 196,731 shares. The aggregate share premium for this transaction amounts to € 312,154.16.
On 8 October 2020, as a result of the conversion of the convertible bonds placed via a private placement announced on 29 April 2020, the share capital was increased by € 106,802.16 with issuance of 209,416 shares. The aggregate share premium for this transaction amounts to € 280,691.85.
Via the Private Placement on 15 December 2020, the Company has raised EUR 9.92 million and placed 4,408,881 new shares with current and new institutional investors in Belgium. The share capital was increased by €2,248,529. The aggregate share premium for this transaction amounts to €7,671,471. Following the capital increase, the share capital of the Company amounted to €8,414,913 and was represented by 16,478,168 shares.
| Date | Transaction | Number and class of shares issued |
Issue price per share (€) including issuance premium |
Capital increase/dec rease (€) |
Share capital after transaction (€) |
Aggregate number of shares after capital increase |
|---|---|---|---|---|---|---|
| 05/02/2015 | Capital increase | 2,012,500 | 16 | 6,077,750 | 16,544,052.63 | 5,470,740 |
| 05/02/2015 | Capital increase | 1,077,039 | 9.51 | 3,252,658 | 19,796,710.41 | 6,547,779 |
| 10/02/2015 | Capital increase | 301,875 | 16 | 911,663 | 20,708,372.90 | 6,849,654 |
| 30/10/2017 | Incorporation of losses |
None | Not applicable | -6,045,571 | 14,662,801.49 | 6,849,654 |
| 09/03/2018 | Capital increase/conver sion convertible bonds |
565,773 | 10.61 | 1,210,754 | 15,873,555.71 | 7,415,427 |
| 04/2018 – 06/2018 |
Capital increase/conver sion convertible bonds |
216,923 | 8.66 (average issue price) |
464,215 | 16,337,770.93 | 7,632,350 |
| 09/07/2018 | Incorporation of losses |
None | Not applicable | -4,830,335 | 11,507,435.80 | 7,632,350 |
| 07/2018— 12/2018 |
Capital increase/conver sion convertible bonds |
678,196 | 8.30 (average issue price) |
1,024,076 | 12,531,511.76 | 8,310,546 |
| 01/2019 – 06/2019 |
Capital increase/conver sion convertible bonds |
641,425 | 3.56 (average issue price) |
968,552 | 13,500,063.51 | 8,951,971 |
| 01/07/2019 | Capital increase | 1,351,352 | 3.70 | 2,040,542 | 15,540,605.03 | 10,303,323 |
| 10/07/2019 | Capital increase/conver sion convertible bonds |
49,522 | 3.79 (average issue price) |
74,778 | 15,615,383.25 | 10,352,845 |
| 21/08/2019 | Capital increase/conver sion convertible bonds |
93,952 | 3.51 (average issue price) |
141,868 | 15,757,250.77 | 10,446,797 |
| 11/09/2019 | Capital increase/conver sion convertible bonds |
33,200 | 3.54 (average issue price) |
50,132 | 15,807,382.77 | 10,479,997 |
| 14/11/2019 | Capital increase/conver sion convertible bonds |
140,689 | 3.13 (average issue price) |
212,440 | 16,019,823.16 | 10,620,686 |
| 12/12/2019 | Incorporation of losses |
None | Not applicable | -10,592,226 | 5,427,597.19 | 10,620,686 |
| 18/12/2019 | Capital increase/conver sion convertible bonds |
51,208 | 3.17 (average issue price) |
26,116 | 5,453,713,27 | 10,671,894 |
| 29/01/2020 | Capital increase/conver sion convertible bonds |
158,235 | 3.37 (average issue price) |
80,700 | 5,534,413.12 | 10,830,129 |
| 26/02/2020 | Capital increase/conver sion convertible bonds |
120,218 | 3.78 (average issue price) |
61,311 | 5,595,724.30 | 10,950,347 |
| 25/03/2020 | Capital increase/conver sion convertible bonds |
156,064 | 2.79 (average issue price) |
79,593 | 5,675,316.94 | 11,106,411 |
| 30/04/2020 | Capital increase / conversion convertible bonds |
398.632 | 2.51 (average issue price) |
203,302.32 | 5,878,619.26 | 11.505.043 |
| 07/05/2020 | Capital increase / conversion |
158.097 | 2.45 (average issue price) |
80,629.47 | 5.959.248.73 | 11.663.140 |
| convertible bonds |
||||||
|---|---|---|---|---|---|---|
| 21/08/2020 | Capital increase / conversion convertible bonds |
196,731 | 2.10 (average issue price) |
100,332.81 | 6,059,581.54 | 11,859,871 |
| 08/10/2020 | Capital increase / conversion convertible bonds |
209,416 | 1.85 (average issue price) |
106,802.16 | 6,166,383.70 | 12,069,287 |
| 15/12/2020 | Capital increase | 4,408,881 | 2.25 | 2,248,529 | 8,414,913.01 | 16,478,168 |
Pursuant to the decision of the extraordinary shareholders' meeting of the Company held on 9 July 2018 and in accordance with article 7 of the Company's articles of association, the Board has received certain powers within the framework of the authorised capital.
Indeed, on 9 July 2018, the shareholders' meeting decided, in accordance with Articles 604 and 607 paragraph 2, 2° of the old Belgian Companies Code (since then replaced by Articles 7:199 and 7:202 of the BCCA) to renew, for a period of five years, the authorisation of the Board to increase the Company's share capital by a maximum aggregate amount of €11,043,220.58 under the same conditions as those currently provided for in article 7 of the articles of association of the Company, including in the event that the Company receives a communication from the Financial Services and Markets Authority ("Autorité des services et marchés financiers" - FSMA) indicating that it has been informed of a takeover bid concerning the Company.
The Board is authorised to increase the share capital within the framework of the authorised capital, on one or more occasions in the following cases:
The Board may, in the interests of the Company and in compliance with and within the limits of the conditions provided for in the BCCA, limit or cancel the preferential subscription right, even in favour of one or more specified persons, other than the employees of the Company or its subsidiaries.
The capital increases decided pursuant to this authorisation may be carried out by contributions in cash or, within the limits of legal conditions, in kind, with or without the creation of new shares, preferential or not, with or without voting rights, with or without subscription rights. These capital increases may be carried out with or without share premium. The issue premiums, if any, will be allocated to the "Issue Premiums" account which, like the share capital, will constitute the guarantee of third parties and may only be disposed of in accordance with the legal provisions in force for the amendment of the articles of association, except in the case of the incorporation of these premiums into the capital account.
Since the renewal of the authorised capital by the extraordinary shareholders' meeting on 9 July 2018, the Board has made use of its powers as described above:
Consequently, the Board is therefore authorized to increase the share capital of the Company within the framework of the authorized capital for a maximum amount of €5,976,496.14 (excluding any issue premiums).
At any given time, the shareholders' meeting can resolve to increase or decrease the share capital of the Company. Such resolution must satisfy the quorum and majority requirements that apply to an amendment of the articles of association.
Subject to the same quorum and majority requirements that apply to an amendment of the articles of association, the shareholders' meeting can authorize the Board of Directors, within certain limits, to increase the Company's share capital without any further approval of the shareholders. This authorization needs to be limited in time (i.e. it can only be granted for a renewable period of maximum five years) and in scope (i.e. the authorized share capital may not exceed the amount of the share capital at the time of the authorization).
On 9 July 2018, the extraordinary shareholders' meeting of the Company granted authorization to the Board of Directors to increase the Company's share capital, in one or several times, with a maximum amount of €11,043,220.58 (excluding issuance premiums, if any).
If the Company's share capital is increased within the limits of the authorized share capital, the Board of Directors is authorized to request payment of an issuance premium. This issuance premium will be booked on a non-available reserve account, which may only be decreased or disposed of by a resolution of the shareholders' meeting subject to the same quorum and majority requirements that apply to an amendment of the articles of association.
The Board of Directors can make use of the authorized share capital for capital increases subscribed for in cash or in kind, or effected by incorporation of reserves, issuance premiums or revaluation surpluses, with or without issue of new shares. The Board of Directors is authorized to issue convertible bonds, bonds cum warrants or warrants within the limits of the authorized share capital and with or without preferential subscription rights for the existing shareholders.
The Board of Directors is authorized, within the limits of the authorized share capital, to limit or cancel the preferential subscription rights granted by law to the existing shareholders in accordance with article 596 and following of the Belgian Companies Code. The Board of Directors is also authorized to limit or cancel the preferential subscription rights of the existing shareholders in favor of one or more specified persons, even if such persons are not members of the personnel of the Company or its subsidiaries.
This authorization was granted for a term of five years commencing from the date of the publication of the resolution in the Annexes to the Belgian Official Gazette (Moniteur belge ; 26 July 2018), and can be renewed.
In principle, from the date of the FSMA's notification to the Company of a public takeover bid on the financial instruments of the Company, the authorization of the Board of Directors to increase the Company's share capital in cash or in kind, while limiting or canceling the preferential subscription right, is suspended. However, the Company's extraordinary shareholders' meeting held on 9 July 2018 expressly granted the Board of Directors the authority to increase the Company's share capital, in one or several times, from the date of the FSMA's notification to the Company of a public takeover bid on the financial instruments of the Company and subject to the limitations imposed by the Belgian Companies Code. This authorization is granted until 9 July 2021.
The Company currently has 3 subscription rights plans outstanding:
On 24 February 2014, the extraordinary general shareholders' meeting of the Company created and approved a plan which consisted in the issue of 113,760 subscription rights for employees, consultants and Directors (plan A). At the date of the Document, 87,998 subscription rights have been granted and accepted. The Ordinary General Meeting of 10 June 2020 took note of the number of Plan A subscription rights still available for granting, i.e. 25,761 subscription rights and decided to cancel the said residual subscription rights.
On 28 May 2020, the Board of directors of the Company created and approved a plan which consisted in the issue of 69,978 subscription rights for employees, management members and Directors (plan 2020/05).
On 23 December 2020, the Board of directors of the Company created and approved a plan which consisted in the issue of 99,832 subscription rights for employees, management members and Directors (plan 2020/12).
On 31 December 2020, the following subscription rights are outstanding in accordance with the abovementioned plan:
| Plan | Total |
|---|---|
| CEO | 109,724 |
| CFO | 43,500 |
| CBO | 5,000 |
| Consultant | 5,000 |
| Board members | 31,330 |
| Former CTMO | 5,333 |
| Former CEO | 28,000 |
| Former CMO | 5,000 |
| Total | 232,887 |
The relevant terms and conditions of the Company's existing warrant plan A are set out below:
The relevant terms and conditions of the Company's existing warrant plan 2020 of May and December are set out below:
At 31 December 2020, the share capital of the Company amounts to €8,414,913.01 and is fully paid up. It is represented by 16,478,168 shares, each representing a fractional value of €0.51 or one 16,478,168th of the share capital. The Company's shares do not have a nominal value.
No takeover bid has been instigated by third parties in respect of the Company's equity during the previous financial year and the current financial year.
The articles of the association of the Company do not impose any additional notification obligations other than the notification obligations required in accordance with Belgian law. The voting rights of the major shareholders of the Company differ in no way from the rights of other shareholders of the Company.
At 31 December 2020, there are 16,478,168 shares representing a total share capital of the Company of €8,414,913.01. There are only ordinary shares, and there are no special rights attached to any of the ordinary shares, nor special shareholder rights for any of the shareholders of the Company. The total number of attributed warrants is 232,887.
The graph5 below provides an overview of the shareholders that have notified the Company of their ownership of securities of the Company. This overview is based on the most recent transparency declaration submitted to the Company.

5 Denominator for S.R.I.W. & Sofipole = 12,069,287, denominator for CPH Banque = 16,478,168 and denominator for SFPI = 6,549,779. .
Dividends can only be distributed if, following the declaration and payment of the dividends, the amount of the Company's net assets on the date of the closing of the last financial year as follows from the statutory financial statements prepared in accordance with Belgian GAAP (i.e., the amount of the assets as shown in the balance sheet, decreased with provisions and liabilities), decreased with the non-amortized activated costs of incorporation and extension and the non-amortized activated costs for research and development, does not fall below the amount of the paid-up capital (or, if higher, the called capital), increased with the amount of non-distributable reserves. In addition, pursuant to the Belgian Company Code and the articles of association, the Company must allocate at least 5% of its annual net profits under its statutory non-consolidated accounts to a legal reserve until the reserve equals 10% of the Company's share capital.
In accordance with Belgian law, the right to collect dividends declared on ordinary shares expires five years after the date the Board of Directors has declared the dividend payable, whereupon the Company is no longer under an obligation to pay such dividends.
The Company has never declared or paid any dividends on its shares.
The Company's dividend policy will be determined by, and may change from time to time by determination of, the Company's Board of Directors. Any declaration of dividends will be based upon the Company's earnings, financial condition, capital requirements and other factors considered important by the Board of Directors. The calculation of amounts available to be distributed as dividends or otherwise distributed to shareholders must be made on the basis of the Belgian statutory financial statements, taking into account the limits set out in the Belgian Company Code.
Belgian law and the Company's articles of association do not require the Company to declare dividends. The Board of Directors expects to retain all earnings, if any, generated by the Company's operations for the development and growth of its business and does not anticipate paying any dividends to the shareholders in the near future.
The Board of Directors, represented by all its members, declares that, to the best of its knowledge, the consolidated financial statements for the twelve-month period ended 31 December 2020, which have been prepared in accordance with the International Financial Reporting Standards as adopted by the European Union, give a true and fair view of the assets, liabilities, financial position and loss of the Company and the undertakings included in the consolidation as a whole, and that the management report includes a fair review of the important events that have occurred during the twelve months of the financial year and of the major transactions with the related parties, and their impact on the consolidated financial statements, together with a description of the principal risks and uncertainties that the Company can face.
On behalf of the Board of Directors,
mC4Tx SRL, Finsys Management SRL,
represented by Miguel Forte represented by Jean-Luc Vandebroek


| Consolidated Assets IFRS per: (in thousands of euros) |
Note | 31/12/20 | 31/12/19 |
|---|---|---|---|
| Non-current assets | 6,019 | 10,660 | |
| Intangible assets | 8.5.1 | 28 | 28 |
| Property, plant and equipment | 8.5.2 | 226 | 6,100 |
| Investments in associates | 8.5.3 | 12 | 332 |
| Financial assets | 8.5.6 | 1,296 | 140 |
| Deferred tax assets | 8.5.4 | 4,456 | 4,059 |
| Current assets | 18,817 | 11,733 | |
| Trade and other receivables | 8.5.5 | 3,840 | 3,025 |
| Other current assets | 328 | 75 | |
| Cash and cash equivalents | 8.5.8 | 14,648 | 8,633 |
| TOTAL ASSETS | 24,835 | 22,393 | |
| Consolidated Liabilities IFRS per: (in thousands of euros) |
Note | 31/12/20 | 31/12/19 |
| Equity attributable to owners of the parent | 3,325 | 2,048 | |
| Share capital | 8,415 | 5,454 | |
| Share premium | 67,594 | 58,026 | |
| Accumulated losses | (73,080) | (61,586) | |
| Other reserves | 396 | 154 | |
| Non-controlling interests | 0 | 0 | |
| Total Equity | 8.5.8 | 3,325 | 2,048 |
| Non-current liabilities | 11,720 | 11,006 | |
| Interest bearing borrowings | 8.5.9 | 11,720 | 11,006 |
| Other non-current liabilities | 0 | 0 | |
| Current liabilities | 9,790 | 9,339 | |
| Interest bearing borrowings | 8.5.9 | 3,077 | 2,709 |
| Trade and other payables | 8.5.10 | 5,514 | 3,841 |
| Current tax liabilities | 0 | 0 | |
| Other current liabilities | 8.5.10 | 1,199 | 2,788 |
| Total liabilities | 21,509 | 20,344 | |
| TOTAL EQUITY AND LIABILITIES | 24,835 | 22,393 |
| (in thousands of euros) | Note | For the year ended 31 December |
|
|---|---|---|---|
| 2020 | 6 2019 |
||
| Revenues | 8.6.1 | 1,000 | 0 |
| Other operating income | 8.6.2 | 2,666 | 2,491 |
| Total revenues and operating income | 3,666 | 2,491 | |
| Research and development expenses | 8.6.3 | (15,416) | (7,501) |
| General and administrative expenses | 8.6.4 | (3,267) | (2,936) |
| Operating profit/(loss) | (15,017) | (7,946) | |
| Interest income | 8.6.6 | 24 | 1,041 |
| Financial expenses | 8.6.6 | (747) | (602) |
| Exchange gains/(losses) Share of profit/(loss) of associates |
8.6.6 8.6.6 |
(13) 0 |
(15) 0 |
| Result Profit/(loss) before taxes | (15,754) | (7,522) | |
| Income taxes | 8.6.8 | (78) | 0 |
| Net Income (Loss) from continuing operations | (15,832) | (7,522) | |
| Net Income (Loss) from discontinued operations | 8.6.9 | 3,891 | (2,813) |
| TOTAL COMPRENHENSIVE INCOME (LOSS) OF THE PERIOD | (11,940) | (10,336) | |
| Basic and diluted loss per share (in euros) – continuing | |||
| operations | 8.6.8 | (1.35) | (0.79) |
| Basic and diluted loss per share (in euros) – discontinued operations |
8.6.8 | 0.33 | (0.29) |
| Profit/(loss) for the period attributable to the owners of the Company | (11,940) | (10,461) | |
| Profit/(loss) for the period attributable to the non-controlling interests | 0 | 125 | |
| Total comprehensive income for the period attributable to the owners of | |||
| the Company | (11,940) | (10,461) | |
| Total comprehensive income for the period attributable to the non | |||
| controlling interests | 0 | 125 |
6 2019 figures have been restated due discontinued operation
| Consolidated Statements of Cash Flows (in thousands of euros) |
For the twelve-month period ended 31 December |
|
|---|---|---|
| 2020 | 2019 | |
| CASH FLOW FROM OPERATING ACTIVITIES | ||
| Operating profit/(loss) Adjustments for: |
(17,448) | (11,174) |
| Depreciation, Amortization and Impairments Share-based compensation |
601 266 |
753 (472) |
| Grants income related to recoverable cash advances Grants income related to patents |
(1,450) (52) |
(1,908) (6) |
| Grants income related to tax credit Other |
(853) (88) |
(578) (77) |
| Movements in working capital: Trade and other receivables (excluding government grants) Trade and other Payables |
(1,014) 1,723 |
(5) (183) |
| Cash generated from operations | (18,315) | (13,650) |
| Cash received from licensing agreement | 0 | 900 |
| Cash received from grants related to recoverable cash advances | 1,745 | 1,901 |
| Cash received from grants related to patents | 56 | 141 |
| Cash received from other grants | 117 | 0 |
| Cash received from grants related to tax credit | 394 | 344 |
| Income taxes paid | (78) | (38) |
| Net cash used in operating activities | (16,082) | (10,400) |
| CASH FLOW FROM INVESTING ACTIVITIES | ||
| Interests received Purchases of property, plant and equipment |
2 (78) |
8 (289) |
| Purchases of intangible assets | (15) | (21) |
| Proceed from the sale of SCTS | 12,000 | 0 |
| Net cash used in investing activities | 11,909 | (302) |
| CASH FLOW FROM FINANCING ACTIVITIES | ||
| Proceeds from government loans | 748 | 815 |
| Repayment of government loans | (122) | (736) |
| Proceeds from loans from related parties | 1,550 | 0 |
| Reimbursements of loan from related parties | (1,864) | (229) |
| Reimbursements of loan from lease liabilities | (267) | (203) |
| Proceeds from bank loans | 4,000 | 0 |
| Reimbursements of other financial loans | (4,625) | (250) |
| Interests paid | (679) | (228) |
| Guarantee facilities | (1,200) | 0 |
| Payments to acquire Non-controlling interests | (1,956) | 0 |
| Transaction costs | (1,180) | (632) |
| Proceeds from issue of equity instruments of the Company | 11,793 | 8,520 |
| Proceeds received from convertible loan | 4,000 | 605 |
| Proceeds received from subordinated loan | 0 | 3,500 |
| Net cash generated from financing activities | 10,187 | 11,162 |
| Net increase (decrease in Cash and Cash Equivalents | 6,132 | 459 |
| CASH AND CASH EQUIVALENTS at beginning of year CASH AND CASH EQUIVALENTS at end of year |
8,633 14,648 |
8,174 8,633 |
| Attributable to owners of the parent | ||||||
|---|---|---|---|---|---|---|
| (in thousands of euros) | Share capital |
Share premium |
Accumulated losses & Other reserves |
Total equity attributable to owners of the parent |
Non controlling interests |
TOTAL EQUITY |
| Balance at 1 January 2019 | 14,662 | 42,665 | (53,443) | 3,883 | 0 | 3,883 |
| Total comprehensive income of the | ||||||
| period | 0 | 0 | (10,461) | (10,461) | 125 | (10,336) |
| Issue of share capital | 3,514 | 5,006 | 0 | 8,520 | 0 | 8,520 |
| Decrease of share capital | (10,592) | 0 | 10,592 | 0 | 0 | 0 |
| Transaction costs for equity issue | 0 | (457) | 0 | (457) | 0 | (457) |
| Specific reserve for convertible bonds | 0 | 0 | 306 | 306 | 0 | 306 |
| Allocation to the legal reserve | 0 | 0 | 6 | 6 | 0 | 6 |
| Share-based payment | 0 | 0 | (472) | (472) | 0 | (472) |
| Movement non-controlling interests | 0 | 0 | 125 | 125 | (125) | () |
| Other | 0 | 0 | (11) | (11) | 0 | (11) |
| Balance at 31 December 2019 | 5,454 | 58,027 | (61,432) | 2,048 | 0 | 2,048 |
| Balance at 1 January 2020 | 5,454 | 58,027 | (61,432) | 2,048 | 0 | 2,048 |
| Total comprehensive income of the | ||||||
| period | 0 | 0 | (11,940) | (11,940) | 0 | (11,940) |
| Issue of share capital | 2,961 | 10,534 | 0 | 13,495 | 0 | 13,495 |
| Transaction costs for equity issue | 0 | (966) | 0 | (966) | 0 | (966) |
| Equity component for Convertible | ||||||
| Bonds | 0 | 0 | 199 | 199 | 0 | 199 |
| Specific reserve for convertible bonds | 0 | 0 | 267 | 267 | 0 | 267 |
| Allocation to the legal reserve | 0 | 0 | 3 | 3 | 0 | 3 |
| Share-based payment | 0 | 0 | 266 | 266 | 0 | 266 |
| Movement non-controlling interests | 0 | 0 | 0 | 0 | 0 | 0 |
| Other | 0 | 0 | (48) | (48) | 0 | (48) |
| Balance at 31 December 2020 | 8,415 | 67,594 | (72,684) | 3,325 | 0 | 3,325 |
The movement linked to the specific reserve for convertible bonds and related warrants relates partly to the amount transferred from financial liability to equity. The carrying amount of EUR 2,500 per share is recorded under Share capital and Share premium, while the difference is recorded under that specific reserve.
Bone Therapeutics SA (the "Company") is a limited liability company governed by Belgian law. The address of its registered office is Rue Auguste Piccard 37, 6041 Gosselies, Belgium. The shares of the Company are publicly listed on NYSE Euronext Brussels and Paris since 6 February 2015.
The Company had Skeletal Cell Therapy Support SA "SCTS" as affiliated until 13 November 2020. Bone Therapeutics USA Inc "BT US" together with the Company, it is referred as the "Group"). The Company is active in regenerative therapy specializing for addressing unmet medical needs in the field of bone diseases and orthopedics. The Company combines in-depth knowledge of bone diseases and stem cell science, a strong expertise in both cell manufacturing for human use and cell therapy clinical trials and regulatory affairs, which have allowed to establish a leadership position in the field of cell therapy for orthopedics and bone diseases.
The consolidated financial statements of Bone Therapeutics SA for the twelve months ended 31 December 2020 include Bone Therapeutics SA and its affiliate. These were authorized for issue by the Board of Directors on 28 April 2021. These statements have been audited by Deloitte Réviseurs d'Entreprises SRL, the statutory auditor of the Company and independent registered public accounting firm.
The principal accounting policies applied in the preparation of the consolidated financial statements are set out below.
In the current year, the Group has applied for a number of new and revised IFRSs issued by the International Accounting Standards Board (IASB) that are mandatorily effective for an accounting period that begins on or after 1 January 2020.
The following IFRS standards, interpretations and amendments that have been issued but that are not yet effective, have not been applied to the IFRS financial statements closed on 31 December 2020:
It is not expected that the initial application of the above-mentioned IFRS standards, interpretations and amendments will have a significant impact on the consolidated financial statements. Thers is no material impact of the application of new standards and interpretations that became effective for 2020.
The consolidated financial statements are presented in thousands of euros, unless otherwise stated. Euro is also the functional currency of both the Company and SCTS. The USD is the functional currency of Bone Therapeutics USA Inc. The functional currency is the currency of the economic environment in which an entity operates. The consolidated financial statements have been prepared on a historical basis, unless otherwise stated.
The consolidated financial statements incorporate the financial statements of the Company and entities directly or indirectly controlled by the Company.
Control is achieved when the Company:
The Company reassesses whether or not it controls an investee if facts and circumstances indicate that there are changes to one or more of the three elements of control. When the Company has less than a majority of the voting rights of an investee, it has power over the investee when the voting rights are sufficient to give it the practical ability to direct the relevant activities of the investee unilaterally. The Company considers all relevant facts and circumstances in assessing whether or not the Company's voting rights in an investee are sufficient to give it power, including:
• the size of the Company's holding of voting rights relative to the size and dispersion of holdings of the other vote holders;
Profit or loss and each component of other comprehensive income are attributed to the owners of the Company and to the non-controlling interests.
All intragroup assets and liabilities, income, expenses and cash flows relating to transactions between members of the Group are eliminated in full on consolidation.
An associate is an entity over which the Group has significant influence and that is neither a subsidiary nor an interest in a joint arrangement. Significant influence is the power to participate in the financial and operating policy decisions of the investee but is not control or joint control over those policies.
In its consolidated financial statements, the Group uses the equity method of accounting for investments in associates and joint ventures. Under the equity method, the investment is initially recognized at cost in the consolidated statement of financial position and adjusted thereafter to recognize the Group's share of the profit or loss and other comprehensive income of the associate or joint venture.
An investment in an associate is accounted for using the equity method from the date on which the investee becomes an associate or joint venture. On acquisition of the investment, any excess of the cost of the investment over the Group's share of the net fair value of the identifiable assets and liabilities of the investee is recognized as goodwill, which is included in the carrying amount of the investment. Any excess of the Group's share of the net fair value of the identifiable assets and liabilities over the cost of the investment, after reassessment, is recognized immediately in profit or loss in the period in which the investment is acquired.
The Group discontinues the use of the equity method from the date when the investment ceases to be an associate or a joint venture or when the investment is classified as held for sale.
Intangible assets are recognized if and only if it is probable that future economic benefits associated with the asset will flow to the Group and the cost of that asset can be measured reliably. Intangible assets with finite useful lives that are acquired separately are measured at cost less accumulated amortization and accumulated impairment losses. The cost of a separately acquired intangible asset comprises its purchase price, including import duties and non-refundable purchase taxes, after deducting trade discounts and rebates. Any directly attributable cost of preparing the asset for its intended use is also included in the cost of the intangible asset. Amortization is recognized on a straight-line basis over the estimated useful lives. The estimated useful life and amortization method are reviewed at the end of each reporting period, with the effect of any changes in estimate being accounted for on a prospective basis. Intangible assets with indefinite useful lives that are acquired separately are carried at cost less accumulated impairment losses. Recognition of costs in the carrying amount of an intangible asset ceases when the asset is in the condition necessary for it to be capable of operating in the manner intended by the Group.
Intangible assets acquired in a business combination are measured at fair value at the date of acquisition. Subsequent to initial recognition, intangible assets acquired in a business combination are subject to amortization and impairment test, on the same basis as intangible assets that are acquired separately.
| Intangible assets | Estimated useful life |
|---|---|
| Software | 3 years |
An intangible asset is derecognized on disposal, or when no future economic benefits are expected from use or disposal. Gains or losses arising from derecognition of an intangible asset, measured as the difference between the net disposal proceeds and the carrying amount of the asset, are recognized in profit or loss when the asset is derecognized.
Consistently with industry practices, management concluded that development costs incurred by the Group do not meet the recognition conditions before Phase III of the related development project is finalized.
Property, plant and equipment are recognized as assets at acquisition or production cost if and only if it is probable that future economic benefits associated with the asset will flow to the Group and the cost of the asset can be measured reliably. The cost of an item of property, plant and equipment comprises its purchase or production price and any costs directly attributable to bringing the asset to the location and condition necessary for it to be capable of operating in the manner intended by management, together with the initial estimation of the costs of dismantling and removing the asset and restoring the site on which it is located, if applicable.
After initial recognition at historical cost, property, plant and equipment owned by the Group are depreciated using the straight-line method and are carried on the balance sheet at cost less accumulated depreciation and impairment. Depreciation begins when the asset is capable of operating in the manner intended by management and is charged to profit or loss, unless it is included in the carrying amount of another asset. The components of an item of property, plant and equipment with a significant cost and different useful lives are recognized separately. Lands are not depreciated. The residual value and the useful life of property, plant and equipment are reviewed at least at the end of each reporting period. The depreciation method is also reviewed annually.
| Property, plant and equipment | Estimated useful life |
|---|---|
| Buildings | 20 years |
| Office furniture | 4 years |
| Lab equipment | 3 to 5 years |
| IT equipment | 3 years |
An item of property, plant and equipment is derecognized upon disposal or when no future economic benefits are expected to arise from the continued use of the asset. Any gain or loss arising on the disposal or retirement of an item of property, plant and equipment is determined as the difference between the sales proceeds and the carrying amount of the asset and is recognized in profit or loss.
The determination of classification of leases is made at the inception of the lease: whether fulfilment of the arrangement is dependent on the use of a specific asset or assets or the arrangement conveys a right to use the asset.
The Group leases laboratory equipments, facilities, car and IT equipment.
Leases are recognized as a right-of-use asset and a corresponding liability at the date at which the leased asset is available for use by the Group. Each lease payment is allocated between the liability and finance cost. The finance cost is charged to profit or loss over the lease period so as to produce a constant periodic rate of interest on the remaining balance of the liability for each period. The right-of-use asset is depreciated over the shorter of the asset's useful life and the lease term on a straight-line basis.
Assets and liabilities arising from a lease are initially measured on a present value basis. Lease liabilities include the net present value of the following lease payments:
The lease term covers the non-cancellable period for which the Group has the right to use an underlying asset, together with both:
The lease payments are discounted using the interest rate implicit in the lease. If that rate cannot be determined, the lessee's incremental borrowing rate is used, being the rate that the lessee would have to pay to borrow the funds necessary to obtain an asset of similar value in a similar economic environment with similar terms and conditions.
Right-of-use assets are measured at cost comprising the following:
Payments associated with short-term leases and leases of low-value assets (determained by the Management) are directly recognized as an expense in the comprehensive income statement. Short-term leases are leases with a lease term of 12 months or less and low-value assets primarily comprise IT equipment.
The Group does not sublease any equipment to external parties. If the Group will sublease any equipment, the Group will assess whether the sublease is a finance or operating lease in the context of the right-of-use asset being leased. The sublease is classified as a finance lease if it transfers substantially all the risks and rewards incidental to ownership of the underlying right-of-use asset. It is classified as an operating lease if it does not transfer substantially all the risks and rewards incidental to ownership of the underlying right-of use asset.
At the end of each reporting period, the Group assess whether there is any indications that an asset may be impaired. If any such indication exists, the recoverable amount of the asset is estimated in order to determine the extent of the impairment loss, if any. Recoverable amounts of intangible assets with an indefinite useful life and intangible assets not yet available for use are tested for impairment at least annually, and whenever there is an indication that the asset may be impaired. Where it is not possible to estimate the recoverable amount of an individual asset, the Group estimates the recoverable amount of the cash-generating unit to which the asset belongs.
Recoverable amount is the higher of an asset's fair value less costs of disposal and its value in use. The value in use is the present value of the future cash flows expected to be derived from an asset or cash-generating unit. In assessing the value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset for which the estimates of future cash flows have not been adjusted.
An impairment loss is recognized whenever recoverable amount is below carrying amount. If the recoverable amount of an asset (or cash-generating unit) is estimated to be less than its carrying amount, the carrying amount of the asset (or cash-generating unit) is reduced to its recoverable amount. An impairment loss is recognized immediately in profit or loss.
Where an impairment loss subsequently reverses, the carrying amount of the asset (or a cash-generating unit) is increased to the revised estimate of its recoverable amount, but so that the increased carrying amount does not exceed the carrying amount that would have been determined had no impairment loss been recognized for the asset (or cash-generating unit) in prior years. A reversal of an impairment loss is recognized immediately in profit or loss. An impairment loss on goodwill can never be reversed.
Financial assets and financial liabilities are recognized when a group entity becomes a party to the contractual provisions of the instrument.
Financial assets and financial liabilities are initially measured at fair value (except for trade receivables that are measured at transaction amount). Transaction costs that are directly attributable to the acquisition or issue of financial assets and financial liabilities (other than financial assets and financial liabilities at fair value through profit or loss) are added to or deducted from the fair value of the financial assets or financial liabilities, as appropriate, on initial recognition. Transaction costs directly attributable to the acquisition of financial assets or financial liabilities at fair value through profit or loss are recognized immediately in profit or loss.
The financial assets include receivables (including trade receivables and other receivables), derivative financial instruments, financial assets at fair value through profit or loss, cash and cash equivalents.
The acquisitions and sales of financial assets are recognised at the transaction date.
All recognised financial assets are subsequently measured in their entirety at either amortised cost or fair value, depending on the classification of the financial assets.
Debt instruments that meet the following conditions are subsequently measured at amortised cost:
Debt instruments include:
Receivables related to government grants, including recoverable cash advances ("avances récupérables"), are recognised when there is reasonable assurance that the Group will comply with the conditions attaching to them and the grant will be received, which generally corresponds to the date at which the Group obtains a confirmation letter from the authorities (see "government grants" below).
In relation to the impairment of financial assets an expected credit loss model is applied. The expected credit loss model requires the Group to account for expected credit losses and changes in those expected credit losses at each reporting date to reflect changes in credit risk since initial recognition of the financial assets.
Specifically, the following assets are included in the scope for impairment assessment for the Group: 1) trade receivables; 2) non-current receivables 3) cash and cash equivalents.
IFRS 9 provides a simplified approach for measuring the loss allowance at an amount equal to lifetime expected credit losses for trade receivables without a significant financing component (short-term trade receivables). The Group determines the expected credit losses on these items by using a provision matrix, estimated based on historical credit loss experience based on the past due status of the debtors, adjusted as appropriate to reflect current conditions and estimates of future economic conditions. Accordingly, the credit risk profile of these assets is presented based on their past due status in terms of the provision matrix.
IFRS 9 requires the Group to measure the loss allowance for a financial instrument at an amount equal to the lifetime expected credit losses if the credit risk on that financial instrument has increased significantly since initial recognition. On the other hand, if the credit risk on a financial instrument has not increased significantly since initial recognition, the Group is required to measure the loss allowance for that financial instrument at an amount equal to 12 month expected credit losses. For long-term receivables IFRS 9 provides a choice to measure expected credit losses applying lifetime or 12 month expected credit losses model. The Group selected the lifetime expected credit losses.
All bank balances are assessed for expected credit losses as well. They may have low credit risk at the reporting date if they are held with reputable international banking institutions.
The effective interest method is a method of calculating the amortized cost of a debt instrument and of allocating interest income over the relevant period.
The effective interest rate is the rate that exactly discounts estimated future cash receipts (including all fees and points paid or received that form an integral part of the effective interest rate, transaction costs and other premiums or discounts) excluding expected credit losses, through the expected life of the debt instrument, or, where appropriate, a shorter period, to the gross carrying amount of the debt instrument on initial recognition.
The amortized cost of a financial instrument is the amount at which the financial asset or liability is measured at initial recognition minus the principal repayments, plus the cumulative amortization using the effective interest method of any difference between that initial amount and the maturity amount, adjusted for any loss allowance on the financial asset. On the other hand, the gross carrying amount of a financial asset is the amortized cost of a financial asset before adjusting for any loss allowance.
Debt and equity instruments are classified as either financial liabilities or as equity in accordance with the substance of the contractual arrangements and the definitions of a financial liability and an equity instrument.
An equity instrument is any contract that evidences a residual interest in the assets of an entity after deducting all of its liabilities. Equity instruments issued by the Group are recognized at the proceeds received, net of direct issue costs. Repurchase of the Company's own equity instruments is recognized and deducted directly in equity. No gain or loss is recognized in profit or loss on the purchase, sale, issue or cancellation of the Company's own equity instruments.
Convertible bonds which include warrants are considered as a single financial instrument measured at fair value through profit and loss (see note 8.3.2).
We refer to note 8.3.2 for more explanation.
Except for the convertible bonds including warrants (see note 8.3.2), which are measured at fair value through profit and loss, all financial liabilities of the Group are subsequently measured at amortized cost using the effective interest method.
Financial liabilities at amortized cost include:
The Group derecognizes financial liabilities when, and only when, the Group's obligations are discharged, canceled or they expire. The difference between the carrying amount of the financial liability derecognized and the consideration paid and payable, including any non-cash assets transferred or liabilities assumed, is recognized in profit or loss.
Government grants are assistance by government, government agencies and similar bodies, whether local, national or international, in the form of transfers of resources to the Group in return for past or future compliance with certain conditions.
The Group recognizes a government grant only when there is a reasonable assurance that the Group will comply with the conditions attached to the grant and the grant will be received. As such, a receivable is recognized in the statement of financial position and measured in accordance with the accounting policy mentioned above (see financial assets).
With respect to Recoverable Cash Advances or RCA's ("Avances Récupérables") whereby in case of successful project completion and a positive decision by the Company to exploit the results of the project, 30% of the amount will be reimbursed through a fixed reimbursement schedule and up to 170% under the form of royalties, the amount recognized as a grant is the difference between the fair value of the expected reimbursement and the actual amount received by the Company as a RCA. The Group recognizes the portion of the RCA that is expected to be reimbursed as a liability. This liability is initially measured at fair value and subsequently at amortized cost, where the carrying amount of a liability is determined by using the effective interest rate. Furthermore, the discount rate is not adjusted every year.
On 10 May 2016, the IFRS Interpretation Committee ("IFRS IC") published the final agenda decision IAS 20— Accounting for repayable cash receipts. In this context, the IFRS IC clarified that an RCA gives rise to a financial liability in the scope of IFRS 9. This financial liability is initially measured at fair value and any difference with the cash to be received from the Walloon Region is treated as a government grant in accordance with IAS 20 Accounting for Government Grants and Disclosure of Government Assistance. Subsequent to the initial recognition, the financial liability is measured at amortized cost using the effective interest method on the basis of the estimated contractual cash flows with changes in value due to a change in estimated cash flows recognized in profit or loss.
In addition, the benefit of a government loan without interest or at a below market rate of interest is treated as a government grant and measured as the difference between the initial discounted value of the loan and the proceeds received or to be received.
Government grants are recognized in profit or loss on a systematic basis over the periods in which the Group recognizes as expenses the related costs which the grants are intended to compensate. As a result, grants relating to costs that are recognized as intangible assets or property, plant and equipment (grants related to assets or investment grants) are deducted from the carrying amount of the related assets and recognized in the profit or loss statement consistently with the amortization or depreciation expense of the related assets. Grants that intend to compensate costs that are expensed as incurred are released as income when the subsidized costs are incurred, which is the case for grants relating to research and development costs as incurred.
Government grants that become receivable as compensation for expenses or losses already incurred are recognized in profit or loss of the period in which they become receivable.
The portion of grants not yet released as income is presented as deferred income in the statement of financial position. In the statement of comprehensive income, government grants are presented as other operating income or financial income depending on the nature of the costs that are compensated.
Derivatives are recognised initially at fair value at the date a derivative contract is entered into and are subsequently remeasured to their fair value at each reporting date. The resulting gain or loss is recognised in profit or loss immediately unless the derivative is designated and effective as a hedging instrument, in which event the timing of the recognition in profit or loss depends on the nature of the hedge relationship. There are currently no hedging instruments.
A derivative with a positive fair value is recognised as a financial asset whereas a derivative with a negative fair value is recognised as a financial liability. Derivatives are not offset in the financial statements unless the Group has both legal right and intention to offset. A derivative is presented as a non-current asset or a non-current liability if the remaining maturity of the instrument is more than 12 months and it is not expected to be realised or settled within 12 months. Other derivatives are presented as current assets or current liabilities.
The options granted and held on the the 50.1% non-controlling interests in the subsidiary SCTS, and the warrants included in the convertible bonds issued in 2018 (see 8.3.2) are the only derivatives outstanding. The warrants are not valued separately, as the whole convertible bond together with the warrants is measured at fair value through profit or loss.
The tax currently payable is based on taxable profit for the year, which differs from profit as reported in the consolidated statement of profit and loss because of items of income or expense that are taxable or deductible in other years and items that are never taxable or deductible. Income tax for the current and prior periods is recognized as a liability to the extent that it has not yet been settled, and as an asset to the extent that the amounts already paid, exceeds the amount due. The Group's current tax is calculated using tax rates that have been enacted or substantively enacted by the end of the reporting period.
Deferred taxes are recognized on temporary differences between the carrying amounts of assets and liabilities in the financial statements and the corresponding tax bases used in the computation of taxable profit.
Deferred tax liabilities are recognized for all taxable temporary differences. Deferred tax assets are recognized for all deductible temporary differences and tax losses carried-forward to the extent that it is probable that taxable profits will be available against which those deductible temporary differences and tax losses carriedforward can be utilized. Such deferred tax assets and liabilities are not recognized if the temporary difference arises from the initial recognition (other than in a business combination) of assets and liabilities in a transaction that affects neither the taxable profit nor the accounting profit.
Deferred tax assets and liabilities are measured at the tax rates that are expected to apply to the period when the asset is realized or the liability is settled, based on tax rates/laws that have been enacted or substantively enacted by the end of the reporting period. The measurement reflects the Group's expectations, at the end of the reporting period, as to the manner in which the carrying amount of its assets and liabilities will be recovered or settled.
The deferred tax asset on the tax credit has been treated as a government grant and presented as other operating income in the consolidated statement of comprehensive income.
The Group is currently not generating revenue from contracts with customers other than from licensing agreements. Most income recognized by the Group is resulting from government grants.
The Group enters into license and/or collaboration agreements with third-party biopharmaceutical partners. Revenue under these arrangements may include non-refundable upfront payments, product development milestone payments, commercial milestone payments and/or sales-based royalties payments.
• Upfront Payment
Licensing revenues representing non-refundable payments received at the time of signature of license agreements are recognized as revenue upon signature of the license agreements when the Group has no significant future performance obligations and collectability of the fees is assured..
• Milestone Payments
Milestone payments represent amounts received from the Group's customers or collaborators. The receipt of which is dependent upon the achievement of certain scientific, regulatory, or commercial milestones. Under IFRS 15, milestone payments generally represent a form of variable consideration as the payments are likely to be contingent on the occurrence of future events. Milestone payments are estimated and included in the transaction price based on either the expected value (probability-weighted estimate) or most likely amount approach. The most likely amount is likely to be most predictive for milestone payments with a binary outcome (i.e., the Group receives all or none of the milestone payment). Variable consideration is only recognized as revenue when the related performance obligation is satisfied, and the Group determines that it is highly probable that there will not be a significant reversal of cumulative revenue recognized in future periods.
Royalty revenues arise from our contractual entitlement to receive a percentage of product sales achieved by co-contracting parties. As the Company has not yet obtained the approval for commercialization, the Company did not yet receive any royalty revenue at the date of the Annual Report. Royalty revenues, if earned, will be recognized on an accrual basis in accordance with the terms of the collaboration agreement when sales can be determined reliably and there is a reasonable assurance that the receivables from outstanding royalties will be collected.
A share-based payment is a transaction in which the Group receives goods or services either as consideration for its equity instruments or by incurring liabilities for amounts based on the price of the Group's shares or other equity instruments of the Group. The accounting for share-based payment transactions depends on how the transaction will be settled, that is, by the issuance of equity, cash, or both equity or cash.
Equity-settled share-based payments to employees and others providing similar services are measured at the fair value of the equity instruments at the grant date. The fair value determined at the grant date of the equity-settled share-based payments is expensed on a straight-line basis over the vesting period, if any, based on the Group's estimate of equity instruments that will eventually vest, with a corresponding increase in equity. At the end of each reporting period, the Group revises its estimate of the number of equity instruments expected to vest. The impact of the revision of the original estimates, if any, is recognized in profit or loss such that the cumulative expense reflects the revised estimate, with a corresponding adjustment to the equitysettled employee benefits reserve.
For cash-settled share-based payments, a liability is recognized for the goods or services acquired, measured initially at the fair value of the liability. At the end of each reporting period until the liability is settled, and at the date of settlement, the fair value of the liability is re-measured, with any changes in fair value recognized in profit or loss for the year.
The Company offers post-employment, death, disability and healthcare benefit schemes to certain categories of employees.
Disability, death and healthcare benefits granted to employees of the Company are covered by an external insurance company, where premiums are paid annually and expensed as they were incurred.
As a consequence of the law of 18 December 2015, the minimum guaranteed rates of return were modified as follows:
In view of the minimum returns guarantees, those plans qualify as Defined Benefit plans.
Due to the fact that the Belgian law prescribes that the employer would guarantee a minimum rate of return on the contributions, such plans are classified as defined benefit plans under IFRS.
The cost of providing benefits is determined using the projected unit credit (PUC) method, with actuarial valuations being carried out at the end of each annual reporting period.
Events after the reporting period which provide additional information about the Group's position at the closing date (adjusting events) are reflected in the financial statements. Events after the reporting period which are not adjusting events are disclosed in the notes if material.
In the application of the Group's accounting policies, which are described above, management is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates. The followings are areas where key assumptions concerning the future, and other key sources of estimation uncertainty at the end of the reporting period, have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial years:
On 7 May 2020, the Company announces that it has received €4.0 million as a result of issuing, to existing investors, subordinated bonds with the option to convert. This enables Bone Therapeutics' bond investors to be repaid in the company's shares, with a conversion price of €7.0 per share. This additional EUR 4.0 million financing has been achieved a week after the €11.0 million financing round.
The unsecured convertible bonds will be issued in registered form, redeemable at 100% of their principal amount with a maturity of 38 months and a coupon of 8% per annum. The coupon will be payable annually. The conversion price of €7.0 per share mitigates the dilution of existing shareholders in the event that the bonds would be redeemed in ordinary shares of Bone Therapeutics.
The Company issued 1,600 bonds at the nominal amount of €2,500 each.
Convertible Bonds entitle bondholders to convert their bonds into a fixed number of shares of the issuing company usually at the time of their maturity. Convertible bonds are a type of compound financial instrument with characteristics of both liability and equity. IFRS propose that the issuing company must separately identify the liability and equity components of convertible bonds and treat them accordingly in the financial statements. For this reason, Management made estimation of the fair value of the liability component which is calculated by discounting the future cash flows of the bonds (interest and principal) at the rate of a similar debt instrument without the conversion option. The total valuation of the liability on 31 December 2020 amounts to € 3.80 million. The Management made judgments in relation of this operation and considered the following elements: a market-based interest of 10% and a a maturity date of 38 months after the issue date for the calculation of the fair value. The difference has been recognized into the equity.
On 7 March 2018, the Company has successfully placed senior, unsecured Convertible Bonds (the "CBs") including warrants with a total commitment of €19.45 million via a private placement.
The Convertible Bonds and related warrants were offered through an accelerated bookbuilding offering, open to institutional investors and such other investors as permitted under applicable private placement exceptions only. Bryan, Garnier & Co. acted as Sole Bookrunner for the Offering.
The CBs are in registered form, denominated €2,500 each. The CBs do not bear any coupon and have a maturity date of twelve months after issuance. The CBs are convertible in ordinary shares at CB holders' convenience before maturity or are automatically converted at maturity date at the Conversion Price. The Conversion Price will be equal to 92% of the Volume-Weighted-Averaged-Price of the Company's shares as provided by Bloomberg LP of the day immediately preceding CB holder's request of conversion or maturity date, but not lower than the par value (€2.14) of the Company's share. Upon conversion of the CBs, the new shares issued shall immediately bear the same right of all other existing shares and could be traded on the Euronext stock exchanges in Brussels and in Paris. The Company has also the right to redeem the CB at a price of €2,577.31 instead of issuing new shares.
Each subscribed CB is accompanied by 19 bond warrants (the "Bond Warrants") in registered form with a warrant term of 19 months. Each Bond Warrant entitles its holder to subscribe to one CB and can be exercised at an exercise price of €2,500 per CB at the request of the warrant holder at any time during the warrant term. All bond warrants have to be exercised during the warrant term and the warrant holders could be obliged to exercise at least one of the 19 Bond Warrants every 30 calendar days.
A total amount of €19.45 million in committed capital has been subscribed during the Offering. In March 2018, part of the investors has decided to immediately exercise warrants resulting in immediate gross proceeds of about €6.58 million and 565,773 new shares to be created, increasing the total outstanding shares from 6,849,654 to 7,415,427 ordinary shares. In the ensuing 26 months, 4,907 bond warrants have been exercised which resulted in additional proceeds of €12.27 million. During the same period, 4,942 bonds have been converted into 2,497,729 shares. On 30 June 2020, there is a total of 11,264,508 ordinary shares outstanding, including 1,351,352 shares issued in the fund raise of June 2019 and 398,632 shares issued in the convertible bond program of April 2020. The remaining warrants when exercised will provide additional proceeds of €0.60 million.
The bonds and its warrants are financial liabilities and are designated as at Fair Value through Profit and Losses (FVTPL).
In the context of measuring and presenting the fair value of the convertible bonds, management has made several assumptions:
The cost associated with the offered discount on the share price at the time of conversion of the bonds has been recognized under financial expenses for an amount of €1.69 million. This cost corresponds to the difference between the fair value of the CBs (issue price divided by 92%) and the issue price (€2,500) for each bond and this for the total number of convertible bonds (7,780) included the outstanding warrants.
Based on current developments and recently signed agreements, the Company has decided to terminate the remaining convertible bond programs issued in March 2018. Following this decision, the Company recognized under financial income an amount of €0.06 million for the remaining amount to be recognized into the equity.
On 29 April 2020, the Company has successfully placed senior, unsecured Convertible Bonds (the "CBs") without any warrants with a total commitment of €6.25 million via a private placement.
The CBs are in registered form, denominated €2,500 each. The CBs do not bear any coupon and have a maturity date of twelve months after issuance. The CBs are convertible in ordinary shares at CB holders' convenience before maturity or are automatically converted at maturity date at the Conversion Price. The Conversion Price will be equal to 94% of the Volume-Weighted-Averaged-Price of the Company's shares as provided by Bloomberg LP of the day immediately preceding CB holder's request of conversion or maturity date. Upon conversion of the CBs, the new shares issued shall immediately bear the same right of all other existing shares and could be traded on the Euronext stock exchanges in Brussels and in Paris. The Company has also the right to redeem the CB at a price of €2,500.00 instead of issuing new shares.
The bonds are financial liabilities and are designated as at Fair Value through Profit and Losses (FVTPL).
In the context of measuring and presenting the fair value of the convertible bonds, management has made several assumptions:
On 29 April 2020, the cost associated with the offered discount on the share price at the time of conversion of the bonds has been recognised under financial expenses for an amount of €0.11 million. This cost corresponds to the difference between the fair value of the CBs (issue price divided by 94%) and the issue price (€2,500) for each bond and this for the total number of convertible bonds (2,500).
A total amount of €6.25 million in committed capital has been subscribed during the Offering. In May 2020, part of the investors has decided to immediately exercise and convert their CBs resulting in immediate gross proceeds of about €1.26 million and 398,632 new shares to be created.
Based on current developments and recently signed agreements, the Company has decided to terminate the remaining convertible bond programs issued in April 2020. Following this decision, the Company has received a total amount of €1.66 million.
Based Based on annual 2021 projected cash burn in a range of €16.00 million to €17.00 million and considering a cash position end of 2020 of about €14.65 million, the Company anticipates having sufficient cash to carry out its business objectives until November 2021.
The Directors remain focused on the Company's liquidity and expect to manage business operations in the next 12 months whilst maintaining adequate liquidity.
In view of the Company significant progress in its clinical programs leading to collection of milestones payment from our partners, combined with ongoing discussions with business and financial partners to obtain sufficient funds, the Board is of the opinion that it is appropriate to prepare the financial statements of the Company under the assumption of going concern.
The Group does not make the distinction between different operating segments, neither on a business or geographical basis in accordance with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker is the Board of Directors of the Company.
All non-current assets are located in Belgium.
The intangible assets consist only of purchased software.
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Acquisition cost | 264 | 248 |
| Accumulated amortization and impairment | (236) | (220) |
| Intangible assets | 28 | 28 |
| Cost (in thousands of euros) |
Software | Clinical developments | Total |
|---|---|---|---|
| Balance at 1 January 2019 | 227 | 0 | 227 |
| Additions | 21 | 21 | |
| Balance at 31 December 2019 | 248 | 0 | 248 |
| Additions | 16 | 16 | |
| Balance at 31 December 2020 | 264 | 0 | 264 |
| Accumulated amortization and impairment (in thousands of euros) |
Software | Clinical developments | Total |
|---|---|---|---|
| Balance at 1 January 2019 | (205) | 0 | (205) |
| Amortization expense | (15) | (15) | |
| Balance at 31 December 2019 | (220) | 0 | (220) |
| Amortization expense | (16) | (16) | |
| Balance at 31 December 2020 | (236) | 0 | (236 |
Property, plant and equipment consist mainly of buildings, laboratory equipment and a property under construction:
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Acquisition cost | 2,463 | 10,384 |
| Accumulated depreciation and impairment | (2,237) | (4,283) |
| Property, plant and equipment | 226 | 6,100 |
Property, plant and equipment (PPE) at the end of December 2020 amount to €0.23 million with a decrease mainly due to the sale of the subsidiary Skeletal Cell Therapy Support that manage the manufacturing facility.
| Cost (in thousands of euros) |
Laboratory equipment |
IT material |
Office furniture |
Land | Building | Cars | Properties under construction |
Total |
|---|---|---|---|---|---|---|---|---|
| Balance at 1 January 2019 | 2,818 | 176 | 104 | 233 | 6,359 | 0 | 56 | 9,747 |
| Additions | 247 | 181 | 5 | 0 | 0 | 163 | 40 | 637 |
| Balance at 31 December 2019 | 3,065 | 357 | 110 | 233 | 6,359 | 163 | 97 | 10,384 |
| Additions | 17 | 0 | 0 | 0 | 0 | 61 | 0 | 78 |
| Disposals | (352) | (87) | 0 | 0 | 0 | (93) | (97) | (629) |
| Linked to discontinued activities | (524) | (219) | (34) | (233) | (6.359) | 0 | 0 | (7.369) |
| Balance at 31 December 2020 | 2.206 | 51 | 75 | 0 | 0 | 131 | 0 | 2.463 |
Total investment at acquisition cost at the end of 2020 amounts to €2.46 million, mainly composed of laboratory equipment. The investment was reduced by €7.37 million due to the sale of Skeletal Cell Therapy Support and €0.63 million due to disposals.
The table below shows the changes in the accumulated depreciation and impairment of property, plant and equipment at the end of 2020.
| Accumulated depreciation and impairment (in thousands of euros) |
Laboratory equipment |
IT material | Office furniture |
Land | Building | Cars | Properties under construction |
Total |
|---|---|---|---|---|---|---|---|---|
| Balance at 1 January 2019 | (2,372) | (159) | (100) | (14) | (899) | 0 | 0 | (3,544) |
| Depreciation expense | (261) | (77) | (4) | (2) | (434) | (88) | 0 | (866) |
| Government grant recognition | 0 | 0 | 0 | 0 | 127 | 0 | 0 | 127 |
| Balance at 31 December 2019 | (2,633) | (237) | (104) | (16) | (1,207) | (88) | 0 | (4,283) |
| Depreciation expense | (83) | (4) | 0 | 0 | 0 | (56) | 0 | (143) |
| Disposals | 352 | 87 | 0 | 0 | 0 | 93 | 0 | 532 |
| Linked to discontinued activities | 300 | 105 | 29 | 16 | 1.207 | 0 | 0 | 1.657 |
| Balance at 31 December 2020 | (2.063) | (49) | (75) | 0 | 0 | (50) | 0 | (2.228) |
| Carrying amount (in thousands of euros) |
Laboratory equipment |
IT material | Office furniture |
Land | Building | Cars | Properties under construction |
Total |
|---|---|---|---|---|---|---|---|---|
| Balance at 31 December 2019 | 432 | 120 | 6 | 217 | 5,152 | 76 | 97 | 6,100 |
| Balance at 31 December 2020 |
142 | 2 | 0 | 0 | 0 | 81 | 0 | 226 |
The investment in associates relates to the investment in "SA Invest Mons-Borinage-Centre" for an amount of € 0.01 million. The decrease of € 0.32 million compared to 31 December 2019 is explained by the sale of SCTS in November 2020, which held a 33.99% stake in "Société d'Infrastructures, de Services et d'Énergies" ('SISE').
The following tables detail the amounts recognized in the consolidated statement of financial position with respect to deferred taxes.
| Assets | Liabilities | |||||
|---|---|---|---|---|---|---|
| (in thousands of euros) | 31/12/2020 | 31/12/2019 | 31/12/2020 | 31/12/2019 | ||
| Property, plant and equipment | 0 | 0 | 20 | 108 | ||
| Intangible assets | 466 | 331 | 0 | 0 | ||
| Trade and other receivables | 0 | 23 | 144 | 0 | ||
| Financial liabilities | 157 | 475 | 0 | 0 | ||
| Other non-current liabilities | 0 | 0 | 0 | 0 | ||
| Other current liabilities | 0 | 509 | 8 | 0 | ||
| Total temporary differences | 623 | 1,337 | 171 | 108 |
Tax Credits and Tax Losses carried forward and Temporary Differences
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Tax credits | 4,915 | 4,457 |
| Tax credits related to notional interest deduction | 0 | 28 |
| Tax losses | 21,367 | 21,179 |
| Total | 26,282 | 25,664 |
Deferred Tax Assets and Liabilities Recognized
| Assets | Liabilities | |||
|---|---|---|---|---|
| (in thousands of euros) | 31/12/2020 | 31/12/2019 | 31/12/2020 | 31/12/2019 |
| Deferred tax assets/(liabilities) | 26,929 | 27,001 | 171 | 108 |
| Unrecognized deferred tax assets | (21,842) | (22,437) | 0 | 0 |
| Offsetting | (171) | (108) | (171) | (108) |
| Total recognized deferred taxes | 4,915 | 4,457 | 0 | 0 |
The following table presents an overview of the deductible temporary differences, unused tax losses and unused tax credits for which no deferred tax asset has been recognized:
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Tax credits related to notional interest deduction | 0 | 83 |
| Tax losses | 85,468 | 71,599 |
| Temporary differences | 1,805 | 4,156 |
| Total | 87,273 | 90,905 |
The unrecognized tax credits related to notional interest deduction were expired in 2020. There is no expiry date on the other sources of deferred tax assets.
Furthermore, the deferred tax asset on the tax credit has been treated as a government grant and presented as other operating income in the consolidated statement of comprehensive income (see note 8.6.2).
At closing 2020, there are no unrecognized deferred tax liabilities related to temporary differences associated with investments in subsidiaries and associates. In the financial statement, only the tax credit has been recognized as deffered tax asset that will be obtained in cash by the Company after 5 years because the Group is substantially loss making and likely that will remain so for still some years to come.
The trade and other receivables can be detailed as follows:
| Trade and other receivables | Total | |
|---|---|---|
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
| Trade receivables | ||
| Trade receivables | 1,071 | 132 |
| Write-downs on trade receivables | 0 | 0 |
| Total trade receivables | 1,071 | 132 |
| Other receivables | ||
| Receivable related to taxes | 276 | 308 |
| Receivable related to tax credit | 459 | 397 |
| Receivable related to recoverable cash advances | 1,831 | 1,964 |
| Receivable related to patent grants | 204 | 225 |
| Total other receivables | 2,770 | 2,893 |
| Total trade and other receivables | 3,840 | 3,025 |
Trade and other receivables amount to €3.84 million showing an increase of €0.82 million compared to the end of December 2019.
The increase of the receivables related to the recognition of the upfront payment to be received from Link Health for an amount of €0.93 million net of taxes (increase) and by the recognition of the new conventions of subsidies/recoverable cash advances signed in 2020 for an amount of €2.37 million.
The increase is maily offset by the amounts received during the course of 2020 for RCAs in progress (upfront amounts and amounts received following expense declarations in function of the progress of the works) for a total of €2.49 million and further reconciled under note 8.6.2 (decrease) compared to an amount of €2.37 million of new conventions signed during the year.
The expected credit losses on 31 December 2020 are not material.
Non-current financial assets amounting to to € 1.30 million related to the two bank guarantees of each €0.60 million constituted as a result of the sale of the subsidiary in November 2020. The bank Guarantee has been issued for a term of 18 months as of the Closing Date of the deal, unless if within such period a Claim shall have been made. In any case however each Bank Guarantee will expire unconditionally and automatically on the date which is five (5) years after Closing.
The remaining amount represented the warranty in respect of social security commitments.
Cash and cash equivalents include following components:
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Cash at bank and in hand | 14,493 | 7,128 |
| Short-term bank deposits | 155 | 1,505 |
| Total | 14,648 | 8,633 |
The cash position at the end of December 2020 amounted to €14.65 million compared to €8.63 million at the end of December 2019. The cash and cash equivalents have been impacted by the fact that the Company has collected a proceed of €21.33 million from convertible bonds, subordinated loans and equity instruments (before €1.18 million of transaction costs). In counterparts, the Company has used €21.02 million in operation, investing, and financing activities. The cash position has also been positively impacted by the discontinued activities for an amount of €6.89 million.
The short-term bank deposits have an original maturity date not exceeding 3 months.
There is no expected credit loss on 31 December 2020.
8.5.8. Equity
The Company's equity increased from €2.05 million at the end of December 2019 to €3.33 million (an increase of €1.28 million) on 31 December 2020. The variation is mainly explained by recognition of capital raises for an amount €13.00 million (net of transaction costs) and offset by the result of the Company (a loss of €11.94 million).
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Share capital | 8,415 | 5,454 |
| Share premium | 67,594 | 58,026 |
| Retained earnings | (75,030) | (61,586) |
| Total outside reserves | 979 | 413 |
| Specific reserve for convertible Bonds | 1,950 | 1,481 |
| Other Reserves | 396 | 154 |
| Total Equity | 3,325 | 2,048 |
From January 2020 to June 2020, as a result of the subsequent conversion of the convertible bonds placed via the private placement on 7 March 2018 and on 29 April 2020, the share capital was increased by €0.71 million with issuance of 1,397,393 new shares. The aggregate share premium for this transaction amounts to €2.86 million.
Via the Private Placement on 16 December 2020, the Company has raised €9.92 million and placed 4,408,881 new shares with current and new institutional investors both in Europe and in the US at a price of €2.25 per share. The share capital was increased by €2.25 million. The aggregate share premium for this transaction amounts to €7.67 million.
Following the capital increases, the share capital of the Company amounted to €8.42 million and was represented by 16,478,168 shares. The share premium accounts amount to €67.59 million (including transaction costs).
| Date | Transaction | Number and class of shares issued |
Issue price per share (€) including issuance premium |
Capital increase/dec rease (€) |
Share capital after transaction (€) |
Aggregate number of shares after capital increase |
|---|---|---|---|---|---|---|
| 29/01/2020 | Capital increase/conver sion convertible bonds |
158,235 | 3.37 (average issue price) |
80,700 | 5,534,413.12 | 10,830,129 |
| 26/02/2020 | Capital increase/conver sion convertible bonds |
120,218 | 3.78 (average issue price) |
61,311 | 5,595,724.30 | 10,950,347 |
| 25/03/2020 | Capital increase/conver sion convertible bonds |
156,064 | 2.79 (average issue price) |
79,593 | 5,675,316.94 | 11,106,411 |
| 30/04/2020 | Capital increase / conversion convertible bonds |
398.632 | 2.51 (average issue price) |
203,302.32 | 5,878,619.26 | 11.505.043 |
| 07/05/2020 | Capital increase / conversion convertible bonds |
158.097 | 2.45 (average issue price) |
80,629.47 | 5.959.248.73 | 11.663.140 |
| 21/08/2020 | Capital increase / conversion convertible bonds |
196,731 | 2.10 (average issue price) |
100,332.81 | 6,059,581.54 | 11,859,871 |
| 08/10/2020 | Capital increase / conversion convertible bonds |
209,416 | 1.85 (average issue price) |
106,802.16 | 6,166,383.70 | 12,069,287 |
| 15/12/2020 | Capital increase | 4,408,881 | 2.25 | 2,248,529 | 8,414,913.01 | 16,478,168 |
Please find also below the evolution of the shares:
| (in euros) | 2020 | 2019 |
|---|---|---|
| Total shares on 1 January | 10,671,894 | 8,310,546 |
| Increase of shares | 5,806,274 | 2,361,348 |
| Total shares on 31 December | 16,478,168 | 10,671,894 |
The Company currently has 3 subscription rights plans outstanding:
• On 23 December 2020, the Board of directors of the Company created and approved a plan which consisted in the issue of 99,832 subscription rights for employees, management members and Directors (plan 2020/12).
| Plan | 31/12/2019 | Offered | Cancelled | Loss | 31/12/2020 |
|---|---|---|---|---|---|
| Plan A | 69,331 | 0 | 0 | 0 | 69,331 |
| Plan 2020/05 | 0 | 63,724 | 0 | 0 | 63,724 |
| Plan 2020/12 | 0 | 99,832 | 0 | 0 | 99,832 |
| Total | 69,331 | 163,556 | 0 | 0 | 232,887 |
Please find the variation in the outstanding warrants during the year 2020:
The following plans were established during the year 2014 and 2020:
| Plan | Beneficiaries | Number of warrants issued |
Number of warrants granted |
Exercise price of warrants granted (€) |
Expiry | |
|---|---|---|---|---|---|---|
| Warrant Plan A | Employees, consultants or Directors |
113,760 | 87,998 | 4.11, 7.72 and 8.77 | February 2024 |
|
| Warrant 2020/05 |
Plan | CEO, CFO | 69,978 | 63,724 | 2.74 | May 2027 |
| Warrant 2020/12 |
Plan | Employees, consultants or Directors |
93,578 | 99,8327 | 2.55 | December 2027 |
| TOTAL | 277,316 | 251,554 |
For relevant terms and conditions of the Company's existing warrant plans, please refer to section 6.4.2.
The main terms and the fair value at grant date of warrants granted out of Plan A, Plan 2020/05 and 2020/12 are as follows:
| Options series | Number | Grant Date | Expiry date | Exercise price |
Fair Value at grant date |
|---|---|---|---|---|---|
| (1) Warrant Plan A | 24,000 | 19-12-16 | 18-12-21 | 7.72 | 3.10 |
| (2) Warrant Plan A | 5,333 | 31-08-17 | 01-02-21 | 8.77 | 3.18 |
| (3) Warrant Plan A | 4,000 | 28-02-19 | 18-12-21 | 4.11 | 1.95 |
| (4) Warrant Plan A | 35,998 | 28-02-19 | 23-02-24 | 4.11 | 1.95 |
| (5) Warrant Plan 2020/05 | 63,724 | 29-05-20 | 29-05-27 | 2.74 | 1.52 |
| (6) Warrant Plan 2020/12 | 99,832 | 23-12-20 | 23-12-27 | 2.55 | 1.56 |
7 6,254 warrants were granted in December 2020 but issued in May 2020
The fair value of the warrants has been determined at grant date based on the Black-Scholes formula. The variables, used in this model, are:
| Plan A - 2016 |
Plan A - 2017 |
Plan A - 2019 |
Plan 2020/05 |
Plan 2020/12 |
|
|---|---|---|---|---|---|
| Number of warrants granted | 24,000 | 16,000 | 47,998 | 63,724 | 99,832 |
| Exercise price (in €) | 7.72 | 8.77 | 4.11 | 2.74 | 2.55 |
| Fair value of the share at grant date | 7.72 | 8.77 | 4.11 | 2.74 | 2.75 |
| Expected dividend yield | 0 | 0 | 0 | 0 | 0 |
| Expected volatility | 35.80% | 35.80% | 56.40% | 57.10% | 57.10% |
| Risk-free interest rate | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Duration in years | 6.15 | 5.15 | 4.98 | 7.00 | 7.00 |
| Fair value (in €) | 3.10 | 3.18 | 1.95 | 1.52 | 1.55 |
There was no warrant exercised in 2020. The expenses relating to these plans are disclosed in point 8.8.3.
Financial liabilities are detailed as follows:
| Non-current | Current | Total | ||||
|---|---|---|---|---|---|---|
| (in thousands of euros) |
31/12/2020 | 31/12/2019 | 31/12/2020 | 31/12/2019 | 31/12/2020 | 31/12/2019 |
| Lease liabilities | 50 | 170 | 32 | 178 | 82 | 348 |
| Government loans | 4,637 | 4,556 | 870 | 500 | 5,507 | 5,056 |
| Loans from related parties |
106 | 1,079 | 675 | 203 | 781 | 1,282 |
| Bank debt | 0 | 1,875 | 1,500 | 250 | 1,500 | 2,125 |
| Convertible Bonds | 3,601 | 0 | 0 | 1,578 | 3,601 | 1,578 |
| Non-Convertible Bonds | 3,325 | 3,325 | 0 | 0 | 3,325 | 3,325 |
| Total financial liabilities |
11,720 | 11,006 | 3,077 | 2,709 | 14,797 | 13,715 |
There are some outstanding covenants with respect to the financial liabilities, such as related to the Novallia loans in case the Company has difficulties regarding continuity. In case of of Public Take-over bid, we refer to section 6.5.
The finance lease liabilities relate to the leases of laboratory equipment (lease term of 3 or 5 years) and cars for an amount of €82,000. The decrease is mainly related to all IT leased located in the subsidiary SCTS and transferred to Catalent Gosselies SA.
The Group has options to purchase the equipment for a fixed amount at the end of the lease term. The Group's obligations under finance leases are secured by the lessors' title to the leased assets. Interest rates underlying the obligations under finance leases related to laboratory and production equipment are fixed at respective contract dates ranging from 2.2% to 5% per annum.
The future minimum lease payments related to these finance leases can be reconciled as follows to the liabilities recognized in the consolidated statement of financial position:
| Future minimum lease payments (in thousands of euros) |
31/12/2020 | 31/12/2019 |
|---|---|---|
| Not later than 1 year | 29 | 182 |
| Later than 1 year and not later than 5 years | 52 | 150 |
| Later than 5 years | 0 | 267 |
| Less: future finance charges | (12) | (253) |
| Present value of minimum lease payments | 70 | 346 |
| Present value of minimum lease payments (in thousands of euros) |
31/12/2020 | 31/12/2019 |
|---|---|---|
| Not later than 1 year | 27 | 176 |
| Later than 1 year and not later than 5 years | 42 | 150 |
| Later than 5 years | 0 | 21 |
| Present value of minimum lease payments | 70 | 346 |
The government loans relate to the repayable part of recoverable cash advances (not linked to turnover) and are detailed in note 8.2.14. Interest is charged to this repayable part at a rate based on Euribor 1 year + 100 basis point or IBOR 1 year + 100 basis point if higher.
The Company has been provided with a bridge loan of €0.75 million from Sambrinvest in April 2020. At 31 December 2020, the outstanding amount equal to €0.56 million and has been fully reimbursed in January 2021.
The Company has taken up two three bridge loans in May 2020 BNP Paribas Fortis SA/NV (€1.50 million), ING Belgique SA/NV (€1.50 million) and Belfius Banque SA/NV (€1.00 million) to finance its activities until the new capital raise. Those 3 loans have a term of 1 year at the latest of at the next capital raise. On 31 December 2020, the Company has reimbursed €0.75 million to BNP Paribas Fortis and ING and €1.00 million to Belfius.
We refer to note 8.3.2 where the valuation of the corresponding financial liability has been described.
Via the Bond Issuance of June 2019, the Company has raised €3.5 million. The non-dilutive subordinated bonds were issued in registered form, redeemable at 100% of their principal amount with a maturity of 48 months and a coupon of 8% per annum. The coupon will be payable annually. The Company also recorded some transactions costs of €0.18 million in deduction of the gross amount received in 2019. These are not part of Effective Interest Rate.
| Non-cash changes | ||||||
|---|---|---|---|---|---|---|
| (in thousands of euros) | 31/12/19 | Cash flows |
New contracts |
Change in estimated cash flows |
31/12/20 | |
| Finance lease liabilities | 347 | (93) | 0 | (172) | 82 | |
| Government loans | 5,057 | (123) | 477 | 96 | 5,507 | |
| Loans from related parties | 1,283 | (2,052) | 1,550 | 0 | 781 | |
| Bank debt | 2,125 | (4,625) | 4,000 | 0 | 1,500 | |
| Convertible Bonds | 1,578 | (1,578) | 3,601 | 0 | 3,601 | |
| Non-Convertible Bonds | 3,325 | 0 | 0 | 0 | 3,325 | |
| Total liabilities from financing activities |
13,715 | (8,471) | 9,628 | (76) | 14,797 |
Trade and other payables are detailed as follows:
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Trade payables | 5,171 | 3,069 |
| Other payables | 343 | 772 |
| Total trade and other payables | 5,514 | 3,841 |
Trade payables (composed of supplier's invoices and accruals for supplier's invoices to receive at reporting date) are non-interest bearing and are in general settled 30 days from the date of invoice.
The increase of €1.67 million is mainly related to trade payables which include important invoices related to the Contract Research Organizations ("CRO") for the ongoing clinical studies (JTA & ALLOB).
Other current liabilities consist of the deferred income related to the government grants as detailed in the following table:
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Deferred income on grants related to recoverable cash advances | 1,184 | 801 |
| Deferred income on grants related to patents | 15 | 32 |
| Put Option | 0 | 1,956 |
| Total | 1,199 | 2,788 |
The deferred income related to the grants on the recoverable cash advances is detailed in note 8.6.2.
The decrease of the other current liabilities is mainly explained by the exercice of the PUT option by the noncontrolling interests of Skeletal Cell Therapy Support SA. The Company acquired 100% of the sales of SCTS before the sale of the subsidiary to Catalent Gosselies SA.
In 2020, the Company recognized an upfront payment from licensee Link Health & Pregene, after the signature of the License agreement in October 2020 for an amount of €1.00 million.
| (in thousands of euros) | 31/12/20 | 31/12/19 |
|---|---|---|
| License | 1,000 | 0 |
| Other | 0 | 0 |
| Total | 0 | 0 |
The Company has signed an exclusive license agreement for the manufacturing, clinical development and commercialization of Bone Therapeutics' allogeneic, off-the-shelf, bone cell therapy platform ALLOB in China (including Hong Kong and Macau), Taiwan, Singapore, South Korea, and Thailand. This agreement has been signed with Link Health Pharma Co., Ltd ("Link Health") and Shenzhen Pregene Biopharma Company, Ltd ("Pregene").
Under the agreement, Bone Therapeutics is eligible to receive up to €55 million in development, regulatory and commercial milestone payments including €10 million in upfront and milestone payments anticipated in the next 24 months. Bone Therapeutics is also entitled to receive tiered double-digit royalties on annual net sales of ALLOB. Bone Therapeutics retains development and commercialization rights to ALLOB in all other geographies outside of those covered by this agreement. As a result, Bone Therapeutics will continue to concentrate on its development and commercialization plans for ALLOB in the US and Europe and novel innovative cell-based products globally.
The agreement grants Link Health and Pregene exclusive rights to clinically develop and commercialize ALLOB for the treatment of human bone disorders in Greater China, Taiwan, Singapore, South Korea, and Thailand. All rights for China will be transferred to Pregene and Link Health will gain rights for the remaining countries Bone Therapeutics will share its patented proprietary manufacturing expertise for the expansion and differentiation of bone-forming cells and has the option to sell clinical supplies to Link Health and Pregene in preparation for their clinical development of ALLOB.
The core principle of IFRS 15 is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The new standard establishes a five-step approach to revenue recognition:
In October 2020, the Group entered into a patent and know-how license agreement with Link Health & Pregene in which an upfront non-refundable payment of € 1.00 million was received (in February 2021). In addition, this contract incorporates multiple development milestone payments, sales-based milestone payments and royalty payments.
Under IFRS 15, two distinct performance obligations could be identified (step 2 of the model), the provision of a license on some of the Company's IP and the provision of technical assistance. The license is considered as a right to use under IFRS 15. Revenue in respect of a distinct license that is a right to use shall be recognised at a point in time under IFRS 15 when the license is granted to Link Health & Pregene (this is made possible by the fact that the license is mature and by the fact that the Company has not planned to carry out additional work). The license is granted in 2020, therefore, that portion of the transaction price that is allocated to the license (step 4 of the model) will be recognized in 2020. The Management of the Company determined that the allocation to the provision of the technical assistance would lead to an immaterial amount. The standalone selling price of the license will be then fully recognized at 2020. The impact recognized into the equity statement amounted to € 1.00 million.
In determining the transaction price, the transaction price is initially limited to the upfront non-refundable payment. The development milestones under the contract that qualify as variable consideration are initially not considered because of the related constraint principles under IFRS 15.
The other operating income relate to the different grants received by the Group:
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Grants income related to recoverable cash advances | 1,198 | 1,247 |
| Grants income related to exemption on withholding taxes | 331 | 434 |
| Grants income related to tax credit | 856 | 575 |
| Grants income related to patents | 52 | 6 |
| Other grants income | 229 | 230 |
| Total | 2,666 | 2,491 |
The recoverable cash advances ("Avances récupérables") are granted to support specific research and development programs. After the approval of these loans by the government (i.e., Walloon Region), a receivable is recognized for the loan to be received and presented as other receivables (see note 8.5.5). These loans become refundable under certain conditions, including the fact that the Group decides to exploit the R&D results of the project. In such case, part of the loan (30%) becomes refundable based upon an agreed repayment schedule, whereas the remaining part (70% and up to 170%) only becomes refundable to the extent revenue is generated within 10 or 25 years after the date at which exploitation has been decided. Accordingly, if no revenue is generated within that period of 10 or 25 years, any non-refunded part of the loan will ultimately not be repaid.
RCA's are partially recognized as a financial liability at the time of signing the agreement as explained in section 8.2.14 above and corresponding to the present value of the expected reimbursements discounted at a rate ranging between 1.08% and 17.1%. The difference between the actual amount received and the amount recognized as financial liability is considered as a government grant and is presented under the caption "deferred income". The deferred income is released as "other operating income" as the R&D costs compensated by the grant are incurred. The part of the grant representing the discount effect on the minimum refundable amount is released as interest income over the period of the interest free loan.
The receivable related to the recoverable cash advances is reconciled as follows:
| (in thousands of euros) | 31/12/20 | 31/12/19 |
|---|---|---|
| Opening balance | 1,964 | 4,705 |
| New grants | 1,589 | 0 |
| New loans | 780 | 0 |
| Canceled grants | (10) | (25) |
| Cash received | (2,493) | (2,716) |
| Closing balance | 1,831 | 1,964 |
The movements related to the debt of the government loans are detailed in the following table:
| (in thousands of euros) | 31/12/20 | 31/12/19 |
|---|---|---|
| Opening balance | 5,056 | 7,430 |
| New loans | 477 | 0 |
| Repayment | (122) | (720) |
| Stop PREOB | 0 | (1,595) |
| Impact of interests | 63 | (84) |
| Unwind of discount | 31 | 23 |
| Closing balance | 5,507 | 5,056 |
The deferred income related to the recoverable cash advances recognized in the consolidated statement of financial position can be reconciled as follows:
| (in thousands of euros) | 31/12/20 | 31/12/19 |
|---|---|---|
| Opening balance | 801 | 2,675 |
| Released as operating income | (1,450) | (1,908) |
| Unwind of discount | (31) | (23) |
| Canceled grants | (12) | (25) |
| Impact of interests | (15) | 84 |
| Increase on new grants | 1,893 | 0 |
| Closing balance | 1,184 | 801 |
For more detail on this section, see note 8.2.16.
Companies that employ scientific researchers and qualify as "R&D center" benefit from a partial exemption from payment of withholding tax on the salaries of scientific staff. They must transfer to the tax authorities only 20% of the withholding tax due on the salary of these researchers while the remaining amount is considered to be a government grant. These grants are recognized in the consolidated statement of comprehensive income at the same moment the related personnel expenses are incurred.
The Group receives government grants related to patents. On average, the grants received cover 70% of the fees incurred in the process of obtaining patents.
Considering that patent costs are expensed as incurred, related patent grants are immediately recognized as other operating income when the patent fees are incurred.
In 2020, the Group has received a subsidy from INAMI for the development of R&D activities.
| (in thousands of euros) |
31/12/2020 | 31/12/2019 |
|---|---|---|
| Lab fees and other operating expenses | 11,587 | 3,644 |
| Employee benefits expenses | 3,368 | 3,413 |
| Depreciations, amortization and impairment losses | 148 | 200 |
| Patents costs | 313 | 242 |
| Total | 15,416 | 7,501 |
Research and development expenses in 2020 were at €15.42 million compared to €7.50 million in 2019. The increase is mainly related to the increase in R&D operating expenses from clinical operations with the "CRO" for the Clinical trial for JTA in Phase III and ALLOB in Phase IIB for the difficult fractures.
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Employee benefits expenses | 1,428 | 1,446 |
| Depreciation and amortization expense | 25 | 28 |
| Other expenses | 1,814 | 1,462 |
| Total | 3,267 | 2,936 |
General and administrative expenses for the full year 2020 amounted to €3.27 million compared to €2.94 million over the same period last year. The increase is mainly the result of the non-recurrent fees related to the deals happened during the year.
Employee benefits expenses can be detailed as follows:
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Short term benefits | 3,865 | 4,441 |
| Social security cost | 442 | 584 |
| Post-employment benefits and other benefits | 223 | 305 |
| Share-based compensation | 266 | (472) |
| Total | 4,796 | 4,859 |
The Group has a group insurance plan based on defined contributions for some employees, for which the insurance company guarantees an interest rate until retirement (type 'branche 21/tak21'). The contributions are a flat percentage of the salary depending on the category of personnel, entirely paid by the employer. By law, the employer has to guarantee a minimum rate of return on the contributions.
Based on an analysis of the plans and the limited difference between the legally guaranteed minimum returns and the interest guaranteed by the insurance company, the Group has concluded that the application of the PUC method would not have a material impact. The accumulated reserve (individualized reserves accumulated with the insurer) amounts to €0.38 million and the accumulated contribution paid amounts to €0.08 million.
| Number of employees | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Research and development | 25 | 40 |
| General and administrative | 5 | 4 |
| Total | 30 | 44 |
| Financial result | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Interest income on bank deposits | 0 | (1) |
| Interest income on government loans | (23) | (16) |
| Recognition of the stop of PREOB | 0 | (1,024) |
| Total financial income | (24) | (1,041) |
| Interest on borrowings | 655 | 212 |
| Interest on government loans | 23 | 16 |
| Interest on obligations under finance leases | 0 | 33 |
| Transaction costs on convertible bonds | 14 | 63 |
| Recognition of the discount on CBs | 55 | 0 |
| Fair value gain or losses | 0 | 278 |
| Total financial expenses | 747 | 602 |
| Exchange (gains)/losses | 13 | 15 |
| Total financial result | 736 | (424) |
Financial expenses amount to €0.75 million in 2020 compared to €0.73 million in 2019 and are mainly impacted by the interest on borrowings (€0.34 million). Last year, the financial expenses were impacted by the Fair value on the Put Option (€0.28 million).
Last year, the financial income amounted to €0.74 million and were composed of the recognition of the stop of research of PREOB for €1.60 million, which corresponds to the part for which reimbursement is turnoverindependent. In 2019, following the results of the Phase III on osteonecrosis, the Company decided to not exploit the results in the future which led to the possibility not to reimburse to liability of the recoverable cash advances linked to PREOB.
The Company recorded an amount of €0.08 million related to the withholding tax related to the milestone from Link Health & Pregene.
| Current tax | 31/12/2020 | 31/12/2019 |
|---|---|---|
| In respect of the current year | 78 | 38 |
| In respect of prior years | 0 | 0 |
| Total income taxes | 78 | 38 |
8 Excluding Skeletal Cell Therapy Support SA
The earnings and weighted average number of ordinary shares used in the calculation of basic earnings per share are as follows:
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Profit/loss for the period attributable to the owners of the Company |
(11,940) | (10,336) |
| Weighted average number of ordinary shares for basic loss per share (in number of shares) |
11,723,182 | 9,538,538 |
| Basic/diluted loss per share (in euros) | (1.02) | (1.08) |
Due to the loss of the period, no dilutive instruments are considered for the diluted earnings per share 2020 and 2019 as the inclusion of these instruments would have an adverse effect, i.e., reducing the loss per share. The impact of the dilutive instruments on the weighted average on ordinary shares would be as follows:
| (in thousands of euros) | 31/12/2020 | 31/12/2019 |
|---|---|---|
| Impact on weighted average number of ordinary shares outstanding | ||
| Share-based payment plan—warrants | 232,887 | 69,331 |
| Convertible bonds and the attributed warrants | 571,428 | 811,442 |
On 16 November 2020, the Company confirmed the completion of the acquisition of Bone Therapeutics' manufacturing subsidiary, Skeletal Cell Therapy Support SA (SCTS) by Catalent Gosselies SA. SCTS was the manufacturing subsdiadry for Bone Therapeutics SA. Following completion of the transaction, SCTS' manufacturing infrastructure and production operating teams have now become part of Catalent's Cell & Gene Therapy division.
| (in thousands of euros) | For the year ended 31 December |
|
|---|---|---|
| 2020 | 2019 | |
| Revenues | 0 | 0 |
| Other operating income | 500 | 829 |
| Total revenues and operating income | 500 | 829 |
| Research and development expenses | (2,632) | (3,683) |
| General and administrative expenses | (299) | (374) |
| Operating profit/(loss) | (2,431) | (3,228) |
| Financial income | 0 | 0 |
| Interest income Financial expenses |
10 (98) |
583 (136) |
| Exchange gains/(losses) | 0 | 0 |
| Share of profit/(loss) of associates | 0 | 6 |
| Result Profit/(loss) before taxes | (2,519) | (2,776) |
| Income taxes | (21) | (38) |
| Net Income (Loss) from discontinued operations | (2,540) | (2,813) |
| Net income(loss) from discontinued operations attributable to: - owners of the parent non-controlling interest - |
(2,540) 0 |
(1,403) (1,410) |
| Capital gain on SCTS sale | 6,390 | 0 |
| Net result | 3,891 | (2,813) |
| (in thousands of euros) | For the year ended 31 December |
||
|---|---|---|---|
| 2020 | 2019 | ||
| Cash flow from operating activities | (2,240) | (2,574) | |
| Cash flow from investing activities | 0 | (63) | |
| Cash flow from financing activities | 9,236 | (109) | |
| Cash flow from discontinued operations (net increase/decrease) | 6,996 | (2,746) |
Please find below the detail of the carrying amount of all assets and liabilities that were disposed as a result of the sale of SCTS:
| (in thousands of euros) | At the signature of the sale of SCTS |
|---|---|
| Building | 4,922 |
| Other PPE | 141 |
| Investment in Associates | 280 |
| Receivables | 378 |
| Cash & Cash equivalents | 585 |
| Total assets | 6,306 |
The following table provides the category in which financial assets and financial liabilities are classified in accordance with IFRS9 – Financial Instruments.
| (in thousands of euros) | IFRS9 Category | 31/12/20 | 31/12/19 |
|---|---|---|---|
| Other non-current financial assets | |||
| Non-current receivables | financial assets at amortized cost | 1,296 | 140 |
| Trade and other receivables | financial assets at amortized cost | 2,035 | 2,188 |
| Cash and cash equivalents | financial assets at amortized cost | 14,648 | 8,633 |
| Total financial assets | 17,979 | 10,961 | |
| Non-current financial liabilities | |||
| Finance lease liabilities | At amortized cost | 50 | 170 |
| Government loans (RCA) |
At amortized cost | 4,637 | 4,556 |
| Loans from related parties | At amortized cost | 106 | 1,079 |
| Non Convertible Bonds | At amortized cost | 3,325 | 3,325 |
| Convertible Bonds | At fair value through profit and loss | 3,601 | 0 |
| Bank debt | At amortized cost | 0 | 1,875 |
| Current financial liabilities | |||
| Finance lease liabilities | At amortized cost | 32 | 176 |
| Government loans (RCA) | At amortized cost | 870 | 500 |
| Loans from related parties | At amortized cost | 675 | 203 |
| Convertible bonds | At fair value through profit and loss | 0 | 1,578 |
| Bank debt | At amortized cost | 1,500 | 250 |
| Trade and other payables | |||
| Trade payables | At amortized cost | 5,171 | 3,069 |
| Other current liabilities | |||
| Put on non-controlling interests | At fair value through profit and loss | 0 | 1,956 |
| Total financial liabilities | 19,968 | 18,739 |
The fair value of financial instruments can be classified into three levels (1 to 3) based on the degree to which the inputs to the fair value measurements are observable:
The fair value of financial instruments has been determined using the following methods:
The carrying amounts of financial assets recognized in the consolidated financial statements at amortized cost approximate their fair values. The same situation is applicable for financial liabilities except as detailed in the following tables:
| 31/12/20 | |||
|---|---|---|---|
| (in thousands of euros) | Carrying amount | Fair value | Fair value level |
| Other non-current financial assets | |||
| Non-current receivables | 1,296 | 1,296 | Level 2 |
| Trade and other receivables | 2,035 | 2,035 | Level 2 |
| Cash and cash equivalents | 14,648 | 14,648 | Level 2 |
| Total financial assets | 17,979 | 17,979 | |
| Non-current financial liabilities | |||
| Finance lease liabilities | 50 | 50 | Level 2 |
| Government loans (RCA) |
4,637 | 6,842 | Level 3 |
| Loans from related parties | 106 | 106 | Level 2 |
| Non Convertible Bonds | 3,325 | 4,564 | Level 2 |
| Convertible Bonds | 3,601 | 3,601 | Level 3 |
| Bank debt | 0 | 0 | Level 2 |
| Current financial liabilities | |||
| Finance lease liabilities | 32 | 32 | Level 2 |
| Government loans (RCA) | 870 | 870 | Level 2 |
| Loans from related parties | 675 | 675 | Level 2 |
| Convertible bonds | 0 | 0 | Level 3 |
| Bank debt | 1,500 | 1,500 | Level 2 |
| Trade and other payables | |||
| Trade payables | 5,171 | 5,171 | Level 2 |
| Other current liabilities | |||
| Put on non-controlling interests | 0 | 0 | Level 2 |
| Total financial liabilities | 19,968 | 23,411 |
| 31/12/19 | |||
|---|---|---|---|
| (in thousands of euros) | Carrying amount | Fair value | Fair value level |
| Other non-current financial assets | |||
| Non-current receivables | 140 | 140 | Level 2 |
| Trade and other receivables | 2,188 | 2,188 | Level 2 |
| Cash and cash equivalents | 8,633 | 8,633 | Level 2 |
| Total financial assets | 10,961 | 10,961 | |
| Non-current financial liabilities | |||
| Finance lease liabilities | 170 | 170 | Level 2 |
| Government loans (RCA) |
4,556 | 7,251 | Level 3 |
| Loans from related parties | 1,079 | 1,297 | Level 2 |
| Non Convertible Bonds | 3,325 | 4,655 | Level 2 |
| Bank debt | 1,875 | 2,057 | Level 2 |
| Current financial liabilities | |||
| Finance lease liabilities | 176 | 176 | Level 2 |
| Government loans (RCA) | 500 | 500 | Level 2 |
| Loans from related parties | 203 | 203 | Level 2 |
| Convertible bonds | 1,578 | 1,578 | Level 3 |
| Bank debt | 250 | 250 | Level 2 |
| Trade and other payables | |||
| Trade payables | 3,069 | 3,069 | Level 2 |
| Other current liabilities | |||
| Put on non-controlling interests | 1,956 | 1,956 | Level 2 |
| Total financial liabilities | 16,783 | 21,206 |
The financial liabilities subsequently measured at fair value on Level 3 fair value measurement are the put option granted by the Group to non-controlling interests in SCTS, which has been fully consolidated, and the convertible bonds and related warrants.
The government loans related to the recoverable cash advances are measured at amortized costs (fair value is disclosed above and is also a Level 3 measurement).
We refer to note 8.3.2 where the valuation of the corresponding financial liability has been described.
Current portion:
| Reconciliation (in thousands of euros) |
31/12/2020 | 31/12/2019 |
|---|---|---|
| Opening balance | 1,578 | 1,279 |
| Cash received | 2,113 | 4,125 |
| Change in fair value | 0 | (306) |
| Total gains or losses in profit or loss | 113 | 0 |
| Transfer to equity | (3,804) | (3,520) |
| Closing balance | 0 | 1,578 |
The liability linked to the convertible bonds and related warrants can only be lower if the assumptions linked to the judgments of management (described under note 8.3.2) would be different.
Non-current portion:
| Reconciliation (in thousands of euros) |
31/12/2020 | 31/12/2019 |
|---|---|---|
| Opening balance | 0 | 0 |
| Cash received | 4,000 | 0 |
| Change in fair value | (199) | 0 |
| Transaction costs | (200) | 0 |
| Closing balance | 3,601 | 0 |
The fair value has been calculated as the weighted average of a best case, base case and worst-case scenario for each project. The weight given to each scenario is as follows:
Based on those scenarios, the fair value, after discounting fixed commitments at rates between 1.08% and 2.91% and the turnover dependent reimbursements at a rate of 17.10% (average rate used by the analysts following the Company) amounts to €7.71 million.
When applying a sensitivity analysis on the above varying the ponderations between the best and base case scenario (decreasing/increasing the PoS of the projects) and varying the discount rate used for discounting
the turnover dependent reimbursements (using a discount rate for a more mature biotech company) we obtain the following results:
| Impact of PoS* | ||||||
|---|---|---|---|---|---|---|
| (in thousands of euros) | -40% | -20% | 0 | +20% | +40% | |
| DCF with discount rate of 17.10% used for turnover dependent reimbursement |
6,982 | 7,286 | 7,712 | 8,222 | 9,487 | |
| DCF with discount rate used for turnover dependent reduced to 12.5%** reimbursement |
7,591 | 7,993 | 8,555 | 9,230 | 10,841 |
* Decrease/increase of best case versus increase/decrease of base case with the worst-case scenario remaining at the same level.
** DCF used for turnover dependent reimbursements.
The table below present only the impacts for JTA:
| Impact of PoS* | ||||||
|---|---|---|---|---|---|---|
| (in thousands of euros) | -40% | -20% | 0 | +20% | +40% | |
| DCF with discount rate of 17.10% used for turnover dependent reimbursement |
1,665 | 1,738 | 1,840 | 1,963 | 2,839 | |
| DCF with discount rate used for turnover dependent reduced to 12.5%** reimbursement |
1,784 | 1,877 | 2,007 | 2,163 | 3,255 |
* Decrease/increase of best case versus increase/decrease of base case with the worst-case scenario remaining at the same level.
** DCF used for turnover dependent reimbursements.
| Impact of PoS* | ||||||
|---|---|---|---|---|---|---|
| (in thousands of euros) | -40% | -20% | 0 | +20% | +40% | |
| DCF with discount rate of 17.10% used for turnover dependent reimbursement |
5,317 | 5,548 | 5,872 | 6,259 | 6,648 | |
| DCF with discount rate used for turnover dependent reduced to 12.5%** reimbursement |
5,807 | 6,116 | 6,548 | 7,067 | 7,586 |
* Decrease/increase of best case versus increase/decrease of base case with the worst-case scenario remaining at the same level.
** DCF used for turnover dependent reimbursements.
The Company believes that its credit risk, relating to receivables, is limited because currently almost all of its receivables are with public institutions. Cash and cash equivalent and short-term deposits are invested with highly reputable banks and financial institutions.
The maximum credit risk, to which the Group is theoretically exposed as at the balance sheet date, is the carrying amount of financial assets. At the end of the reporting period no financial assets were past due, consequently no financial assets were subject to impairment.
The Company manages liquidity risk by continuously monitoring forecast and actual cash flows, and by matching the maturity profiles of financial assets and liabilities.
The Company's main sources of cash inflows are obtained through capital increases, subsidies, government loans and where appropriate loans from commercial banks to finance long-term requirements (investment in infrastructure). A key objective of the Board together with the Executive Directors is to ensure that the Company remains adequately financed to meet its immediate and medium-term needs.
If necessary and appropriate, the Company assures itself of short-term borrowing facilities to cover short-term requirements.
The following table details the Group's remaining contractual maturity of its non-derivative financial liabilities with agreed repayment periods. The tables have been drawn up based on the undiscounted cash flows of financial liabilities based on the earliest date on which the Group can be required to pay. The tables include both interest and principal cash flows. The contractual maturity is based on the earliest date on which the Group may be required to pay.
| 31/12/2020 (in thousands of euros) |
Financial lease liabilities |
Government loans |
Loans from related parties |
Convertible Bonds |
Subordinated Loans |
Bank debt | Total |
|---|---|---|---|---|---|---|---|
| Within one year | 29 | 929 | 688 | 320 | 280 | 1,500 | 3,746 |
| >1 and <5 years | 50 | 1,608 | 107 | 4,640 | 4,060 | 0 | 10,466 |
| >5 and <10 years | 0 | 1,425 | 0 | 0 | 0 | 0 | 1,425 |
| >10 and <15 years | 0 | 908 | 0 | 0 | 0 | 0 | 908 |
| >15 years | 0 | 1,631 | 0 | 0 | 0 | 0 | 1,631 |
| 31/12/2019 (in thousands of euros) |
Financial lease liabilities |
Government loans |
Loans from related parties |
Convertible Bonds |
Subordinated Loans |
Bank debt | Total |
| Within one year | 182 | 516 | 265 | 1,578 | 280 | 301 | 3,122 |
| >1 and <5 years | 150 | 1,756 | 656 | 0 | 4,165 | 1,141 | 7,868 |
| >5 and <10 years | 15 | 1,428 | 749 | 0 | 0 | 916 | 3,108 |
| >10 and <15 years | 15 | 883 | 5 | 0 | 0 | 0 | 898 |
The Company has limited interest rate risk on long-term investments loans granted by regional investment bodies, on subordinated loans and also on turnover independent reimbursements (30%) related to RCA's (related to government loans) concluded as of 2009 which are carrying fixed interest rates. The Group at current does not undertake any hedging.
The Company is currently not exposed to any significant foreign currency risk.
However, should the Company enter into long-term collaboration agreements with third parties for which revenues would be expressed in a foreign currency, the Company might in such case consider entering into a hedging arrangement to cover such currency exposure (in case the related expenditure is planned in local currency). The Company will also monitor exposure in this respect following the establishment of its US subsidiary.
The structure of the group has been described in Chapter 3.
For more detail about the related-party transactions, please refer to Chapter 5.
Balances and transactions between the Company and its subsidiary, which is a related party of the Company, have been eliminated on consolidation and are not disclosed in this note. Details of transactions between the Group and other related parties are disclosed below.
As a result of the relationship of the government (i.e. Walloon Region) with some shareholders of the Company and the extent of financing received, the Company judges that the government is a related party. However, the principal amounts recognized in the financial statements relate to government grants for a total of €35.54 million (2019: €33.15 million). Next to the government grants, government agencies granted loans to the Group for a total amount of €3.97 million (€ 2.42 million in 2019).
The remuneration of key management personnel has been described as follow:
| Period ended 31 December | ||
|---|---|---|
| (in thousands of euros) | 2020 | 2019 |
| Number of management members | 5 | 5 |
| Short-term benefits | 1,350 | 1,365 |
| Share-based payments | 228 | (495) |
| Total | 1,578 | 870 |
| Cumulative number of warrants granted (in units) | 163,224 | 57,333 |
| Shares owned (in units) | 2,880 | 2,880 |
Transactions with the non-executive directors can be summarized as follows:
| (in thousands of euros) | Period ended 31 December | |
|---|---|---|
| 2020 | 2019 | |
| Share-based payments | 38 | 23 |
| Management fees | 148 | 179 |
| Total | 186 | 202 |
| Number of warrants granted (in units) | 31,330 | 7,332 |
| Shares owned (in units) | 47,038 | 47,038 |
The Company has no major commitments for 2021 and beyond.
| Detail of audit and non-audit fees paid during 2020 in € | Amount |
|---|---|
| Statutory and IFRS audit fees Bone Therapeutics | 28,700 |
| Total audit fees Deloitte for FY20 | 28,700 |
| Report for convertible bonds | 7,000 |
| Report on issuance of subscription rights (SOP 2020) | 3,500 |
| Report on the cancellation of subscription rights | 3,500 |
| Report for INAMI subsidies | 4,000 |
| Total non-audit fees Deloitte and related parties | 18,000 |
| TOTAL | 46,700 |
The annual consolidated financial statements on 31 December 2020 were authorized for issue by the Board of Directors of the Company on 28 April 2021. Accordingly, events after the reporting period are those events that occurred between 1 January 2021 and 28 April 2021.
Post period, in January 2021, Bone Therapeutics signed a first agreement for a process development partnership with the mesenchymal stromal cell (MSC) specialist, Rigenerand. This first collaboration will focus on further developing and enhancing Bone Therapeutics' bone-forming cells with the potential to broaden their therapeutic targets and explore new mechanisms of action with potential gene modifications for Bone Therapeutics' therapeutic portfolio.
End March 2021, Bone Therapeutics appointed the stem cell therapy industry veteran, Anthony Ting, PhD, as Chief Scientific Officer. Backed by two decades of expertise in translational clinical development with adult stem cell therapies, Dr. Ting will be responsible for Bone Therapeutics' research activities. His immediate focus will be the further expansion of Bone Therapeutics' pipeline, leveraging internal know-how and external collaborations on novel, specialized cell therapy products with enhanced efficacy, using differentiated and modified MSCs.
In accordance with Art. 3:17 of the Belgian Companies and Associations' Code, it has been decided to present an abbreviated version of the statutory financial statements of Bone Therapeutics SA. These condensed statements have been drawn up using the same accounting principles for preparing the full set of statutory financial statements of Bone Therapeutics SA for the financial year ending 31 December 2020. These financial statements were as such prepared in accordance with the applicable accounting framework in Belgium and with the legal and regulatory requirements applicable to the financial statements in Belgium.
The management report, the statutory financial statements of Bone Therapeutics SA and the report of the statutory auditor will be filed with the appropriate authorities and are available at the Company's registered offices. The statutory auditor has issued an unqualified report on the statutory financial statements of Bone Therapeutics SA. The full set of the statutory financial statements is also available on the Company's website www.bonetherapeutics.com.
| ASSETS (in thousands of euros) |
31/12/20 | 31/12/19 |
|---|---|---|
| Non-current assets | 3,377 | 2,777 |
| Formation expenses | 1,863 | 1,075 |
| Intangible assets | 28 | 71 |
| Property plant and equipment | 147 | 217 |
| Financial fixed assets | 1,339 | 1,414 |
| Current assets | 22,716 | 15,569 |
| Amounts receivable for more than one year | 4,431 | 4,034 |
| Trade and other receivables | 3,363 | 3,327 |
| Investments | 155 | 1,449 |
| Cash and cash equivalents | 14,385 | 6,662 |
| Deferred charges and accrued income | 383 | 97 |
| TOTAL ASSETS | 26,094 | 18,345 |
| EQUITY AND LIABILITIES (in thousands of euros) |
31/12/20 | 31/12/19 |
| Equity | 4,789 | 4,544 |
| Share capital | 8,415 | 5,454 |
| Share premium | 10,898 | 364 |
| Accumulated profits (losses) | (14,524) | (1,274) |
| Non-current liabilities | 11,484 | 6,904 |
| Current liabilities | 9,821 | 6,898 |
| Current portion of amounts payable after one year | 3,057 | 1,945 |
| Trade debts | 5,239 | 3,703 |
| Taxes remuneration and social security | 346 | 552 |
| Other amounts payable | 691 | 277 |
| Accrued charges and deferred income | 489 | 420 |
| Total liabilities | 21,305 | 13,801 |
| TOTAL EQUITY AND LIABILITIES |
| (in thousands of euros) | For the 12-months period ended |
|
|---|---|---|
| 31/12/20 | 31/12/19 | |
| Operating income | 26,938 | 12,866 |
| Turnover | 1,000 | 0 |
| Own construction capitalized | 16,694 | 9,485 |
| Other operating income | 2,854 | 3,380 |
| Non-recurring operating income | 6,390 | 0 |
| Operating charges Services and other goods Remuneration, social security, pensions Depreciation and amounts written off fixed assets Other operating charge |
(39,419) (18,489) (2,521) (17,232) (1,178) |
(25,530) (10,766) (3,337) (10,557) (869) |
| Operating profit/(loss) | (12,481) | (12,664) |
| Financial income | 1 | 1,126 |
| Financial expenses | (691) | (247) |
| Result Profit/(loss) before taxes | (13,172) | (11,785) |
| Income taxes | (78) | 0 |
| TOTAL COMPREHENSIVE INCOME OF THE PERIOD | (13,250) | (11,785) |
The Company ended the year with a loss of €13.25 million. Carried forward losses at the end of 2019 amounted to €1.27 million. The Board of Directors proposes to appropriate the loss for 2020 to losses carried forward. Losses carried forward after appropriation therefore amounts to €14.52 million.
| (in thousands of euros) | 31/12/20 |
|---|---|
| Loss carried forward for the year at 31.12.2019 | (1,274) |
| Loss for the period | (13,250) |
| Incorporation to share capital and share premium | 0 |
| Total loss carried forward | (14,524) |
The valuation rules have been prepared by the Board of Directors in accordance with the requirements of the Royal Decree of 30 January 2001.
Company Formation Expenses
Formation expenses are recorded as intangible fixed assets at their nominal value and depreciated over a period of 5 years. The debt issuance costs are directly recognized into the profit and loss.
R&D costs excluding administrative and financial costs are recognized as assets in an intangible asset account and amortized pro-rata basis over the year for the R&D costs capitalized as from 1 January 2016. For R&D costs capitalized before this change in accounting rules, amortization continues to be applied over a threeyear period.
Receivables are valued at their face value. Non-interest bearing long-term Receivables will be actualized using an appropriate discount rate.
Upon signing agreements with the Walloon Region, advance cash payment will be recorded (when received) and will be debited in line with the part of the expenses reported and claimed which, granting body considers as being paid through the advances.
Revenue recognition of Recoverable cash advances is linked to R&D expenses which according to the new valuation principle applicable as of 1 January 2016, are amortized at 100% in the year of capitalization. For RCA's linked to R&D expenses, which were capitalized before the fiscal year 2016, and which are amortized over a three-year period, revenue recognition of RCA's will be kept in line with the amortizing over this threeyear period.
When the decision is made to exploit the results of the work financed through the recoverable cash advances, the recoverable advances are recognized in debt in full during the year the decision was taken. At the same time, the recoverable cash advance is recognized at 100% in other operating charges. The amount of the debt corresponds to plan set out in an agreement with the Walloon Region.
In case the project is abandoned, the remaining part of the capitalized R&D will be depreciated in an accelerated way and the revenues that are related will also be recognized in an accelerated way.

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