Annual Report • Apr 28, 2022
Annual Report
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Public limited company with a capital of 27,876,782.50 euros Headquarters: 49, boulevard du général Martial Valin – 75015 Paris RCS Paris 410 910 095
"I hereby certify that, to the best of my knowledge, the financial statements have been prepared in accordance with the applicable accounting standards and give a true and fair view of the assets, liabilities, financial position and results of the company and all the companies included in the consolidation, and that the management report on page 5 gives a true and fair view of the business performance, the results and the financial position of the company and all the companies included in the consolidation, and describes the main risks and uncertainties that they face.
Done in Paris, France, on April 28, 2022
Shefali AGARWAL, President and Chief Executive Officer "
| MANAGEMENT REPORT | page 3 |
|---|---|
| INCLUDING THE REPORT ON CORPORATE GOVERNANCE | |
| CORPORATE ACCOUNTS | page 61 |
| CONSOLIDATED ACCOUNTS | page 92 |
| 10.3. | Main developments39 | |
|---|---|---|
| 10.1. 10.2. |
Components of the risk management process35 General principles of internal control 37 |
|
| 10. | RISK MANAGEMENT AND INTERNAL CONTROL PROCEDURES IMPLEMENTED BY ONXEO_ 35 | |
| 9. | TRANSACTIONS BY OFFICERS OR MEMBERS OF THE BOARD OF DIRECTORS IN THE COMPANY'S SECURITIES__________ 34 |
|
| 8. | EMPLOYEE SHAREHOLDING _______ 34 | |
| 7.2. | Acquisition by the Company of its own shares during the year ended December 31, 202133 | |
| 7.1. | Cross-shareholdings and treasury shares33 | |
| 7. | OTHER INFORMATION CONCERNING THE CAPITAL_______ 33 | |
| 6. | FORESEEABLE DEVELOPMENTS AND PROJECTS__________ 32 | |
| 5. | FINANCIAL POSITION IN RELATION TO THE VOLUME AND COMPLEXITY OF THE BUSINESS 32 | |
| 4. | PRESENTATION OF THE GROUP'S CONSOLIDATED ACCOUNTS ____ 31 | |
| 3.6. 3.7. |
Terms of payment statement 30 Amount of loans under three years granted by the Company 29 |
|
| 3.5. | Acquisitions of equity interests and controlling interests at year-end 29 | |
| 3.4. | Table of financial results29 | |
| 3.3. | Non-tax-deductible expenses29 | |
| 3.1. 3.2. |
Review of accounts and results 28 Allocation of results29 |
|
| 3. | PRESENTATION OF ONXEO'S FINANCIAL STATEMENTS AND ALLOCATION OF EARNINGS _ 28 | |
| 2.5. | Main disputes in progress28 | |
| 2.4. | Risks related to the Company, its organization and its environment 26 | |
| 2.3. | Legal Risks24 | |
| 2.1. 2.2. |
Financial risks16 Risks related to the business 20 |
|
| 2. | RISK FACTORS____________ 15 | |
| 1.6. | Significant events after December 31, 202112 | |
| 1.5. | Chronological summary of the Company's press releases in fiscal year 202112 | |
| 1.4. | Governance 11 | |
| 1.3. | Funding 10 | |
| 1.2. | Business trends and significant events during the financial year 7 | |
| 1.1. | THE YEAR __________ 6 Scope of the Group7 |
|
| 1. | SITUATION AND EVOLUTION OF THE COMPANY'S AND THE GROUP'S ACTIVITIES DURING |
| 1. | COMPOSITION AND MISSIONS OF THE BOARD OF DIRECTORS____ 40 | |
|---|---|---|
| 1.1. | Composition of the Board of Directors 40 | |
| 1.2. | Missions of the Board of Directors 40 | |
| 1.3. | Corporate governance code41 | |
| 1.4. | Agreements referred to in Article L. 225-37-4, 2° of the Commercial Code 43 | |
| 2. | CORPORATE MANDATES _________ 43 | |
| 2.1. | Evolution of the Board of Directors. 43 | |
| 2.2. | Offices and positions held by each of the Company's directors 45 | |
| 3. | SHARE SUBSCRIPTION WARRANTS, STOCK OPTIONS AND FREE SHARES __ 48 | |
| 4. | CAPITAL STRUCTURE OF THE COMPANY _________ 52 | |
| 4.1. | Distribution of share capital as of December 31, 202152 | |
| 4.2. | Changes during the year53 | |
| 5. | CAPITAL LIKELY TO BE SUBSCRIBED BY EMPLOYEES AND MANAGERS AND DILUTED CAPITAL ___________ 53 |
|
| Appendix I – Results of the last five years (statutory accounts) _____ 56 | ||
| Appendix II - Summary table of current delegations of authority granted by the General Meeting to | ||
| the Board of Directors to increase the share capital _____ 57 |
This report is prepared in accordance with Articles L. 225--100, L. 233--26 and L. 232--1 of the French Commercial Code and is available to shareholders. Its purpose is to present the evolution of the financial situation of Onxeo (hereinafter referred to as the "Company") and that of the group (hereinafter referred to as the "Group").
In accordance with the provisions of Article L. 225--37 paragraph 6 of the French Commercial Code, the corporate governance report (section II) is included in this management report.
Onxeo is a French clinical-stage biotechnology company that develops new cancer drugs by targeting tumor DNA functions through unique mechanisms of action in the field of DNA Damage Response (DDR).
The Company focuses on the development of innovative or disruptive compounds from preclinical (translational) research to human clinical proof of concept, which represents its know-how and expertise. It thus leads its programs to the most value-creating and attractive inflection points for potential partners.
Onxeo is listed on the Euronext Growth market in Paris and the Nasdaq First North Growth market in Copenhagen.
The Company's portfolio includes:
The Company is convinced that its decoy oligonucleotide technology has significant therapeutic potential and represents a disruptive innovation that could pave the way for a new paradigm in cancer treatment.
The Group comprises the Company, which conducts most of its business, and its subsidiaries, most of which have limited activity:
AsiDNA® positions the Company in a new field at the forefront of scientific and clinical research in oncology, namely tumor DNA damage response (DDR : DNA Damage Response).
DNA damage response consists of a network of cellular pathways that detect, signal and repair DNA damage. Proteins monitor DNA integrity and can activate cell cycle control points and repair pathways in response to damage to prevent the generation of potentially deleterious mutations.
Applied to oncology, this new field of research aims to weaken or block the ability of tumor cells to repair damage to their DNA, either naturally or through cytotoxic treatments. Tumor cells are much more dependent on their DNA repair mechanisms than healthy cells, due to their uncontrolled proliferation.
AsiDNA® is a first-in-class product in the DDR field. It interferes with tumor DNA repair through a highly original decoy agonist mechanism, which originated from research work at the Institut Curie.
The product is composed of a double-stranded DNA fragment that behaves like a fragment of damaged tumor DNA and causes hyperactivation of repair pathways (agonist mechanism) and the hijacking and sequestration of repair proteins (decoy mechanism). AsiDNA® induces an hyper stimulation of DNA repair and a depletion of the tumor cell's repair pathways, which nevertheless continues its replication cycle, but with damaged DNA, leading to cell death. AsiDNA® specifically targets tumor cells: preclinical and clinical studies conducted to date have shown that it has no effect on healthy cells, suggesting a favorable safety profile including in combination with other treatments, which was confirmed in humans after systemic administration in the multi-center DRIIV-1 and DRIIV-1b studies.
Of particular interest is that, unlike targeted products that inhibit a specific protein or pathway, such as PARP inhibitors (PARPi), AsiDNA® interferes with all repair pathways. Acting upstream of multiple pathways, it does not inhibit one or more repair proteins but instead captures and hyperactivates them, thereby disrupting the entire repair cascade. Thus, it does not induce resistance mechanisms to anti-cancer treatment, which all targeted therapies used in oncology nowadays face. This resistance leads to therapeutic failures after several treatment cycles.
This is an important differentiating factor that allows for its use in combination with other tumor DNA damaging agents such as radiotherapy and chemotherapy, or in combination with inhibitors of a specific repair pathway such as PARP inhibitors (PARPi), to significantly increase their efficacy, notably by abrogating resistance to those treatments.
The Group continued the preclinical and clinical development of this lead candidate by systemic route in 2021.
It has been established through several studies that a small population of tumor cells can escape cell death by entering a state of reversible latency when treated with a targeted therapy. These so-called persistent or drug-tolerant persister cells (DTP) are a major source of resistance to targeted therapies, thereby leading to cancer recurrence.
At the AACR 2020 virtual conference, the Company presented preclinical data showing that the combination of AsiDNA® with targeted PARP inhibitor (PARPi) therapies prevented the reactivation of these persistent cells, thereby completely and irreversibly preventing the emergence of tumor resistance.
At the American Association for Cancer Research (AACR) Annual Meeting in April 2021, the Company presented results from preclinical studies that showed the ability of AsiDNA™ to also prevent KRAS inhibitor resistance (KRASi) induced by persistent cells. In addition, new data presented at the EACR-AstraZeneca virtual conference organized by the European Association for Cancer Research and AstraZeneca on "Persistent Drug-Tolerant Cells" in December 2021) confirmed that AsiDNA™, in combination with targeted therapies such as KRAS and EGFR inhibitors, prevents the reactivation of these DTP cells and prevents resistance in tumor models of interest.
These properties of AsiDNA™ could enable it to become a gold standard combination therapy to counter resistance to multiple targeted therapies when induced by persistent cells and thus pave the way for several combination strategies in terms of anti-cancer treatment.
On February 4, 2021, Onxeo announced a research agreement with the Institut Curie to conduct a Phase 1b/2 trial to assess AsiDNA® in combination with radiotherapy in the treatment of recurrent high-grade glioma in children. This study is supported by a grant from the European Fight Kids Cancer program. The objective of this clinical research agreement with the Institut Curie, France's leading cancer center, is to conduct a Phase 1b/2 study to evaluate the effect of AsiDNA® in combination with radiotherapy in pediatric patients with recurrent high-grade glioma (HGG) who are eligible for re-irradiation. This collaboration represents a new clinical step for Onxeo and reflects the Company's commitment to evaluate its drug candidate in indications of very high medical need, which is the case for this indication with a particularly poor prognosis.
In parallel, the Company continued the REVOCAN Phase 1b/2 clinical trial to evaluate the combination of AsiDNA™ with PARP inhibitors in the 2nd line maintenance treatment of relapsed ovarian cancer. Gustave Roussy is the sponsor of this study. The pace of recruitment has been slower than expected, partly due to the health crisis, and the initial results are now expected in the second half of 2022.
The Company pursues an active policy of industrial protection for AsiDNA®, particularly for its most promising potential combinations. In September 2021, the Company was notified that the European Patent Office (EPO) has issued a patent that will strengthen the protection of AsiDNA® combined with PARP inhibitors (PARPi) in Europe.
In particular, this patent protects the method of using AsiDNA® in combination with PARP inhibitors in the treatment of certain cancers in which the homologous recombination (HR) DNA repair pathway is unaltered or deficient, known as "HR-proficient" cancers, which are not very sensitive to treatment with PARP inhibitors.
This patent will provide protection until 2036. It adds to the already robust set of patent families that protect AsiDNA® and its related compounds, both alone and in combination.
AsiDNA® has the potential to be used in a broad spectrum of combinations and multiple indications, which the Group wishes to leverage through partnerships to generate, in both the short and long term, numerous catalysts for growth and value for the Group and its shareholders.
PlatON® is a chemistry platform that allows for the construction of new molecules using three components: the oligonucleotide (a double-stranded fragment of DNA), a linker between the two strands to ensure the stability of the fragment, and a vector to promote cellular penetration (a cholesterol molecule in the case of AsiDNA®). With platON®, Onxeo has the means to enrich its portfolio of highly innovative drug candidates while capitalizing on its expertise and knowledge accumulated in the field of oligonucleotides and DNA repair mechanisms over the past several years.
After AsiDNA®, the first compound derived from platON®, the company has designed a family of new compounds called OX400 derived from its oligonucleotide platform. Based on Onxeo's proprietary agonist decoy technology, the OX400 family is positioned both in the field of DNA damage response (DDR) by acting on PARP, a key protein in tumor DNA repair, and in the field of immuno-oncology.
The preclinical program which has already been completed has confirmed the main properties of the first compound, OX401. The latter exhibits potent antitumor activity, as demonstrated in an animal model of breast cancer, through PARP hyperactivation and the hijacking of its DNA repair function in tumor cells specifically. PARP is a major component of the DNA repair mechanism, and the clinical value of acting on this protein has already been amply demonstrated by PARP inhibitors. Moreover, this activity on PARP induces a strong engagement of the cGAS-STING pathway1 , as demonstrated by the increase in key biomarkers of the tumor immune response. The activation of this pathway is now a very promising new approach in immunooncology.
Benefiting from a novel decoy agonist mechanism of action like all platON®-derived compounds, OX401 does not induce tumor resistance to treatment, which represents a clear differentiation from targeted therapies like PARP inhibitors. Finally, like AsiDNA®, OX401 has no activity on healthy cells, which should give it a favorable safety profile in the clinic.
At the American Association for Cancer Research (AACR) 2021 International Meeting, the Company presented pre-clinical results2 that highlight the properties of the compounds from the OX400 family, as immunomodulatory agents and "metabolic enhancers", i.e. a molecule that "boosts" the antitumor immune response while depleting the metabolic resources of the tumor cells.
During 2021, the Company continued to optimize OX401 in order to improve its action on the PARP protein, which is involved in the tumor DNA repair cascade, and its activation of the antitumor immune response via the cGAS-STING pathway. The Group plans to select the compound with the optimal pharmacokinetic and pharmacodynamic profile (lead compound) and its preclinical development in 2022, including the study of its combination with immune checkpoint inhibitors (immunotherapies).
Belinostat is a histone deacetylase inhibitor (HDACi) that is marketed under the brand name Beleodaq® in the United States for the second-line treatment of patients with peripheral T-cell lymphoma. In April 2020, Onxeo entered into agreements with Acrotech Biopharma LLC that extend Acrotech's commercialization rights for belinostat to all territories that they did not already have under license (i.e. the United States, Canada, Mexico and India) and transfer patent ownership for the oral form of belinostat to them in all territories.
As of the date of the agreements, Onxeo no longer has any responsibility for the development of the product and it is therefore no longer presented in the Company's R&D portfolio.
During 2021, Onxeo continued to receive license royalties from its partner which were fully allocated to the repayment of the bonded debt it contracted with SWK Holdings in June 2018. After the full repayment of this debt, the license will be royalty-free and Acrotech will retain all revenues generated by Beleodaq®.
As of the date of this document, the Company's R&D portfolio is as follows:
1 The cGAS-STING pathway is a component of the innate immune system, which detects cytosolic DNA (involved in particular in carcinogenesis) and induces an immune response as a result.
2 Abstract 527: A new generation of PARP interfering drug candidates for cancer treatment - Wael Jdey, Christelle Zandanel, Véronique Trochon-Joseph, Chloé Doizelet, Vincent Hayes, Marie-Christine Lienafa, Richard Tripelon and Françoise Bono - Proceedings: AACR Annual Meeting 2021; April 10-15, 2021 and May 17-21, 2021; Philadelphia, PA
Management report including the Corporate governance report 2021 Board of Directors meeting of April 6, 2022
| Programmes | PRÉCLINIQUE | PHASE Ia | PHASE Ib | PHASE II | AVEC | PROCHAINES ETAPES |
|---|---|---|---|---|---|---|
| platON® - Plateforme brevetée (oligonucléotides leurres agonistes) |
PLATEFORME DE DECOUVERTE DE CANDIDATS MEDICAMENTS VISANT A ENRICHIR LE PIPELINE D'ONXEO |
Optimisation de nouveaux ▪ composés |
||||
| AsiDNA® -/+ chimiothérapie Tumeurs solides à un stade avancé, toutes lignes de traitement |
DRIIV mono | DRIIV -1b combo | ||||
| AsiDNA® + radiothérapie Gliome de haut grade récurrent (enfants) |
AsiDNA® Children | Premier patient traité au 1er ▪ trimestre 2022 |
||||
| AsiDNA® + PARPi Cancer de l'ovaire en rechute |
REVOCAN | Données préliminaires au 1er ▪ semestre 2022 |
||||
| AsiDNA® + autres thérapies ciblées | ||||||
| Famille OX400 monothérapie et en association Agoniste de PARP + activation de la voie STING |
||||||
| Terminé En cours |
* Les échéances sont indicatives et pourraient être revues ultérieurement |
The changes compared to the portfolio presented when the 2021 half-year results were announced (August 2021 version online on the website) are as follows:
Finalization of the Driiv-1b study with AsiDNA® in combination with chemotherapy,
Start of the phase 1b/2 study evaluating AsiDNA® in combination with radiotherapy in the treatment of recurrent high-grade glioma in children, as part of a clinical research agreement with the Institut Curie, with a first patient treated expected by mid-2022,
Launch in the second half of 2021 of a strategic reflection on the next stages of the AsiDNA® development plan which will be announced in the second quarter of 2022,
Postponement to the second half of 2022, instead of the end of 2021, of the preliminary results of the Revocan study, due to slow recruitment, in particular due to the context of the pandemic.
On January 28, 2021, the Group announced that it had obtained non-dilutive funding of 5 million euros in the form of Government-Backed Loans. This funding is part of the measures put in place by the French government to support French companies in the context of the COVID-19 pandemic and allows the Company to strengthen its cash position.
The loans are 90% guaranteed by the French government, have interest rates ranging from 0.25% to 1.75%, including the government guarantee, and have a 12-month maturity. After this initial period, the Group may, at its discretion, defer repayment of the principal amount for up to five additional years.
In a press release dated March 10, 2021, Onxeo announced the launch of a capital increase with maintenance of the preferential subscription rights of shareholders in France and Denmark, on the basis of the seventeenth and twentieth resolutions adopted by the extraordinary general meeting of shareholders of June 19, 2020. This operation was the subject of a prospectus approved by the AMF under no. 21-063.
The proceeds of this issue of New Shares are intended to primarily finance the expansion and acceleration of development clinical use of AsiDNA ™, especially in combination with other anti-cancer agents. The Group also intends to continue the optimization and preclinical development of new candidates from the platON ™ platform, optimize pharmaceutical development and compound manufacturing operations, and more generally, finance the activity of the Company.
The main terms of the operation are summarized below:
- Subscription parity: 1 new share for 6 existing shares
On April 12, 2021, Onxeo announced the success of this capital increase, with a subscription rate of approximately 104.8%. The gross amount of the capital increase, including share premium, amounts to 9,7 million euros. This transaction extends the Company's cash runway until at least end 2022.
The Company's capital following the capital increase amounts to 22,998,733.75 euros, divided into 91,994,935 shares with a par value of 0.25 euros each.
During 2021, the Company partially renewed its Board of Directors, with the following changes:
As of the date of this document, the Board of Directors is composed of 8 members with 5 men and 3 women, including 5 independent members.
Detailed information on corporate governance can be found in the Corporate Governance Report which follows this Management Report.
The full text of these press releases can be accessed on the Company website at (ww.onxeo.com).
| 1/07/2021 | Publication of the 2020 financial calendar | |||
|---|---|---|---|---|
| 1/08/2021 | Publication of the 2020 annual report on the liquidity contract | |||
| 1/11/2021 | Onxeo announces its participation in major investor and scientific conferences | |||
| 1/28/2021 | Onxeo obtains non-dilutive financing of 5 million euros in the form of Government | |||
| backed Loans | ||||
| 2/02/2021 | Onxeo publishes a Letter to Shareholders and provides an update on its | |||
| developments | ||||
| 2/04/2021 | Onxeo enters into a research agreement with the Institut Curie to conduct a Phase | |||
| 1b/2 trial to evaluate AsiDNA® in combination with radiotherapy in the treatment | ||||
| of recurrent high-grade glioma in children. | ||||
| 3/10/2021 | Onxeo launches a capital increase with preferential subscription rights for | |||
| shareholders to accelerate its R&D programs | ||||
| 3/24/2021 | Onxeo updates its financial calendar | |||
| 4/08/2021 | Onxeo to present new preclinical data at AACR 2021 | |||
| 4/12/2021 | Onxeo announces the success of its capital increase with preferential subscription | |||
| rights for shareholders with €9.7 million raised | ||||
| 4/21/2021 | Onxeo publishes its 2020 financial results and provides an update on its activities | |||
| and outlook | ||||
| 4/23/2021 | Provision of the 2020 annual financial report | |||
| 5/31/2021 | Onxeo announces the formation of an independent Scientific Expert Committee | |||
| composed of leading figures | ||||
| 6/09/2021 | Onxeo receives a notice of allowance in the United States for a new patent that | |||
| extends the protection of AsiDNA® in combination with a PARP inhibitor | ||||
| 6/10/2021 | Minutes of the Combined General Meeting of June 10, 2021 | |||
| 7/29/2021 | Onxeo published its financial results for the first half of 2021 and provided an | |||
| update on its activities | ||||
| 7/29/2021 | Onxeo announces the appointment of Dr. Shefali Agarwal as Chairman of its Board | |||
| of Directors | ||||
| 10/14/2021 | Onxeo expands its Board of Directors with two well-known figures from the | |||
| healthcare sector | ||||
| 11/23/2021 | Onxeo continues to strengthen its Board of Directors | |||
| 12/08/2021 | New preclinical data confirms AsiDNA® 's ability to target "persistent" cells and | |||
| prevent tumor resistance to different treatments in combination |
On January 3, 2022, Onxeo announced the appointment of Mr. Julien Miara as interim CEO, following the decision of the Board of Directors. Julien Miara will work closely with Dr. Shefali Agarwal, Chairman of the Board of Directors, who has extensive experience in drug development, to ensure that the Company progresses according to the established strategic plan and to prepare a successful transition to the next CEO.
Born on June 15, 1983, Julien Miara is a Director at Invus, which he joined in 2010 as an analyst for the investment activity in listed companies (Invus Public Equities LP), particularly covering biotechnologies. In 2018, he was promoted to lead the team in Europe. Previously, he worked in investment banking at BNP Paribas in Paris, Société Générale in New York, and in consulting. Julien Miara obtained his Master's degree in Management from EDHEC Business School in Lille (France) in 2009.
This appointment follows the departure, on the same day, of Ms. Judith Greciet as Chief Executive Officer, a position she had held since June 2011. As a result, Ms. Greciet was reinstated as an employee. She has since seized the labor courts. The procedure is underway and Onxeo intends to contest the grievances raised.
The Group believes that this conflict, which began in February 2022, will have no impact on its business.
On April 6, 2022, Onxeo announced additional funding of €12 million subscribed by its longstanding shareholders Invus and Financière de la Montagne. This financing comprises an €8 million capital increase and a €4 million convertible bond issue. It extends the Company's financial visibility until the second quarter of 2023.
The net proceeds of the issue will be used (i) to develop AsiDNA, the Company's leading product, both clinically and industrially within the framework of ongoing and future clinical trials, (ii) to finalize the optimization of and develop the preclinical program for OX401, both alone and with immune-oncology drugs, and (iii) more generally to finance the Company's running costs.
The capital increase has been carried out through the issuance of common shares with waiver of shareholders' preferential subscription rights reserved for a category of persons in accordance with the thirteenth resolution approved by the Mixed General Meeting of June 10, 2021, based on the provisions of Articles L. 225-129 and following of the Commercial Code.
A total number of 19,512,195 new common shares with a nominal value of €0.25 each were thus issued to the benefit of Invus Public Equities LP and Financière de la Montagne. These new shares represent approximately 21% of the Company's share capital before the implementation of the private placement. The subscription price has been set at €0.410 per new share, corresponding to the weighted average share price over the 3 previous trading sessions (i.e. from April 1 to 5, 2021 inclusive) without a discount, giving net proceeds of €8 million.
The issue is not subject to a prospectus requiring a visa from the AMF French financial market authority.
The admission of the new shares to trading on the Euronext Growth market in Paris occured April 12, 2022. They are listed on the same line as the Company's existing shares (ISIN: FR0010095596), carry current dividend rights and are immediately fungible with the Company's existing shares.
Following completion of the capital increase, the shareholdings of Invus Public Equities LP and Financière de la Montagne is 23.5% and 19.8% of the Company's share capital respectively, based on a total number of 111,507,130 shares, and a shareholder with a 1% stake in the Company has seen its stake reduced to 0.83%. To the Company's knowledge, no other shareholders hold more than 5% of its share capital.
This issuance of bonds convertible into common shares was decided by the Board of Directors in accordance with the thirteenth resolution approved by the Mixed General Meeting of June 10, 2021 (waiver of shareholders' preferential subscription rights via a private placement reserved for a category of persons), based on the provisions of Articles L. 225-129 and following of the Commercial Code.
The convertible bond issue for a nominal amount of €4,000,000 is represented by 4,000,000 convertible bonds with a nominal value of one euro each, giving gross proceeds from the bond issue of €4 million. The convertible bonds have been subscribed by Invus Public Equities LP and Financière de la Montagne to the tune of €2.5 million and €1.5 million respectively.
The bonds are not the subject of a request for admission to trading on the Euronext Growth market. However, any common shares resulting from the conversion of these convertible bonds will be, as soon as they are issued, on the same line as existing common shares (ISIN: FR0010095596).
The issue was not subject to a prospectus requiring a visa from the AMF.
The Company will regularly publish, on its website, the number of new shares issued upon conversion of convertible bonds.
The main characteristics of the convertible bonds are the following:
On April 7, 2022, Onxeo announced the appointment of Dr. Shefali Agarwal as Chief Executive Officer. Shefali Agarwal succeeds Julien Miara, who was appointed Interim Chief Executive Officer in January 2022. Drawing on her extensive experience in oncology, she will lead the Company's strategy and development with an expanded team, particularly in the United States where the Group's clinical and regulatory expertise will be located, with clear objectives: to advance AsiDNA®, a first-in-class tumor DNA damage response inhibitor, in the clinic and to conduct preclinical proof-of-concept studies with OX401 , a next-generation PARP agonist, and its optimized versions.
During the combined general meeting held on April 19, 2022, Julien Miara was appointed director of the Company. He retains his role as permanent representative of Invus, director since June 2020.
The Group operates in a constantly changing environment, which entails numerous risks, some of which are beyond its control. Before subscribing for or acquiring shares in the Company, investors are invited to review all the information contained in this Report, including the risks described below.
The Company has examined the risks to which it is exposed and presents in this section those which, in its opinion, as of the date of this Report, are likely to have a significant adverse effect on its business, prospects, financial situation, results and growth, and which, in this context, are important in making any investment decision. As of the date of this Report, the Company is not aware of any significant risks other than those presented in this section.
Investors' attention is drawn to the fact that, pursuant to Article 16 of the Prospectus Regulation, the list of risks presented in this section is not exhaustive and that other risks, currently unknown or deemed unlikely, as of the date of this Report, to have a material adverse effect on the Company may exist or could arise.
In order to identify and assess the risks likely to have an adverse impact on the Group's business, prospects, financial situation, results (or its ability to achieve its objectives) and development, the Company periodically draws up a map of these risks.
Every identified risk is assessed in terms of probability of occurrence and potential impact, accounting for the possible consequences, in particular from a financial, legal and reputational point of view, as well as on the achievement of the Group's objectives.
Risk mapping is thus a management tool that makes it possible, where appropriate, to define and monitor the preventive or corrective mitigation measures to be implemented in connection with the various risks identified. The associated action plan specifies the actions to be carried out, who is responsible, who is involved, the deadlines to be met and the budget associated with each action.
The risk management process and risk mapping are presented annually to the audit committee as part of its mission to monitor and control the effectiveness of the internal control and risk management systems.
Risk mapping updated as of the date of this Report has enabled the Company to identify 20 risk factors. The probability of occurrence of each risk is assessed on five levels (from 1 - unlikely, to 5 - probable) and their potential negative impact is assessed on five levels (from 1 - limited, to 5 - major).
Multiplying the two criteria gives an overall criticality score for each risk, making it possible to group the risks into three main groups: acceptable, strong or major.
The matrix below graphically presents the 20 risk factors identified according to their probability of occurrence and their potential impact. The numbers correspond to the risk factors listed in the following table, grouped into 4 categories according to their nature, with for each of them the section of this URP where they are described.
Within each of the four categories mentioned above, risks were ranked in order of criticality, with the risks with the highest probability of occurrence and the highest potential impact placed first, on a "net risk" basis, i.e., after accounting for preventive or mitigating measures. The occurrence of new events, either internal or external to the Group, may change this order of importance in the future.
As of the date of this Report, the Company considers that it has limited exposure to risks on its operations due to the Covid-19 epidemic (or any other risk of a pandemic nature) and the Russian-Ukrainian conflict.
However, it does not rule out the possibility that a reactivation of the lockdown measures taken by states and governments or that a continuation or an increase of the measures taken against Russia could affect the smooth running of its subcontracted activities, in particular the conduct of clinical trials and production operations. In addition, the effect of these events on the world's financial markets could have a short-term impact on its ability to finance itself on the capital markets and, consequently, on the conduct of its business. The Company has identified three risks that are likely to be aggravated by this context: they are indicated by an asterisk (*) in the matrix and table below, and the circumstances of aggravation are detailed in the corresponding section.
Management report including the Corporate governance report 2021 Board of Directors meeting of April 6, 2022
| Category/ Number |
Risk factor | Section |
|---|---|---|
| I | Financial risks | 2.1 |
| 1 | Liquidity risk (*) | 2.1.1 |
| 2 | Risk related to the evolution of the Company's shares (*) | 2.1.2 |
| 3 | Risks related to the Research Tax Credit | 2.1.3 |
| 4 | Risk of dilution | 2.1.4 |
| 5 | Risk of not carrying forward tax losses | 2.1.5 |
| 6 | Foreign exchange risk | 2.1.6 |
| II | Risks related to the business | 2.2 |
| 7 | Risk related to the highly innovative nature of the Company's products and the early stage of their development |
2.2.1 |
| 8 | Risk of major delays in development (*) | 2.2.2 |
| 9 | Risk of clinical trial failure | 2.2.3 |
| 10 | Risk of clinical developments in combination | 2.2.4 |
| 11 | Risks related to a binding and evolving legal and regulatory framework | 2.2.5 |
| 12 | Risks related to competition | 2.2.6 |
| 13 | Risk related to industrial and commercial partnerships | 2.2.7 |
| III | Legal Risks | 2.3 |
| 14 | Risks related to industrial protection | 2.3.1 |
| 15 | Risk of legal disputes | 2.3.2 |
| 16 | Risk related to the control regime for foreign investments in France | 2.3.3 |
| IV | Risks related to the Company, its organization and its environment | 2.4 |
| 17 | Risk of dependence on third parties and failure of a subcontractor (*) | 2.4.1 |
| 18 | Risk of loss of key employees | 2.4.2 |
| 19 | Risk associated with the use of hazardous chemicals and biological materials | 2.4.3 |
In 2021 and up to the date of this Report, the Company has financed its growth primarily through:
The Company's cash and cash equivalents were 17.9 million euros at December 31, 2021. The Company relies on leading financial institutions for its cash investments and believes that it does not bear significant credit risk on its treasury.
Taking into account the 12 million euros financing received from its two main shareholders, Invus and Financière de la Montagne, early April 2022, the Company will be able to finance its activities at least into Q2 2023 on the basis of its financing plan.
Beyond this horizon, the advancement of the Company's research and development programs will continue to generate significant funding requirements. The Company's profitability depends primarily on its ability to enter into collaboration or licensing agreements for its drug candidates with industrial partners, which generate upfront and milestone payments and royalties on sales, after market authorization. These processes are lengthy and the Company, which has recorded net operating losses since the beginning of its research and development activities, anticipates further losses in the coming years as its operations continue.
The level of funding requirements and their timing depend on factors largely beyond Onxeo's control, such as:
The Company will therefore have to seek new sources of financing in the future, notably through new capital increases. It does not exclude taking advantage of financing opportunities depending on market conditions to strengthen its equity. The Company cannot guarantee that it will be able to obtain the additional financing required to continue its operations on acceptable financial terms. In addition, debt financing, to the extent available, could include commitments that are binding on the Company and its shareholders.
If the necessary funds are not available, the Company's business activities could be definitively discontinued or, at a minimum, the Company may have to:
In addition, the effect on the global financial markets of the "Covid-19" pandemic and the Russian-Ukrainian conflict has led to a decline in the Company's share price, and these external factors could have a significant short-term impact on the Company's ability to obtain financing in the capital markets and, consequently, on the conduct of its business.
The Company's shares are listed on the SME growth market Euronext Growth in Paris and are also listed on Nasdaq First North in Copenhagen.
The shares of biotech companies are particularly volatile and this situation may continue. The market price of the Company's shares could be materially affected by numerous factors affecting the Company, its competitors, or general economic conditions and the biotechnology industry.
In addition to geopolitical or macro-economic events that may have a strong impact on the equity market, particularly for biotechnology companies, the following factors could have a significant influence on the volatility and share price in particular:
The sale of Company shares or the anticipation that such sales may occur may also have an adverse impact on the Company's share price. The Company cannot predict the possible effects on the market price of the shares should its shareholders sell their shares.
In addition, the terms of any financing may adversely affect the assets or rights of the Company's shareholders, and the issuance of additional securities, whether equity or debt, or the possibility of such issuance, could result in a decline in the Company's share price.
The tables below show the evolution of the share price and the volume of transactions on the Euronext Growth Paris market over the period from January 2 to December 31, 2021
| Market capitalization in millions of euros as of December 31, 2021 | 36.6 |
|---|---|
| Share price (in euros) | |
| • Highest (close of April 9, 2021) | 0.78 |
| • Lowest (close of December 8, 2021) | 0.39 |
| • At the end of the period (December 31, 2021) | 0.42 |

In France, the Company benefits from the Research Tax Credit ("RTC"), which consists of a tax credit offered by the French government to companies investing significantly in research and development. Research expenses that are eligible for the RTC include, in particular, salaries and wages, depreciation of research equipment, services subcontracted to approved research organizations (public or private) and intellectual property costs. The RTC recorded for the year 2021 amounted to 1.7 million euros, which represents significant funding compared to the 17.9 million euros in cash and cash equivalents at December 31, 2021.
It cannot be ruled out that the tax authorities may question the methods used by the Company to calculate research and development expenses, even though the Company complies with the documentation and eligibility requirements for such expenses. In addition, the RTC regime may be subject to regulatory change in the future.
If such a situation were to occur, it could have an adverse effect on the Company's results and financial position.
The Company regularly finances itself on the market through capital increases, which can represent a significant dilution for shareholders.
In addition, as part of its policy of motivating its managers and employees and in order to attract skills, the Company regularly allocates stock warrants, stock options and free shares that have a potential dilutive effect.
At December 31, 2021, the full exercise of all the instruments that give access to the capital allocated and in circulation would allow for the subscription of 4,534,569 new shares, thus generating a dilution equal to 4.9% on the basis of the capital existing at the date of this Report.
The Company has accumulated tax loss carryforwards of 304 million euros as at December 31, 2021.
In France, the allocation of these deficits is capped at 1 million euros, plus 50% of the portion of profits exceeding this ceiling. The unused balance of the deficit can be carried forward to future years and is chargeable under the same conditions without time limit. The amount of tax losses accumulated by Onxeo therefore represents a significant financial issue in terms of reducing future income tax expense when the Company will record profits.
There can be no assurance that future changes in applicable tax laws and regulations will not remove or modify these or other provisions in a manner that is unfavorable to the Company.
The Company incurs a portion of its expenses in currencies other than the euro. In the future, the Company may need to expand its research and development activities internationally, including its clinical trials with AsiDNA® , which could increase its exposure to foreign exchange risk.
In addition, the Company's asset development strategy is based on the signature of license agreements generally involving upfront and milestone payments as well as royalties on sales and it is possible that these agreements will be concluded in the future with partners outside the Euro zone.
The Company's revenues for the year ended December 31, 2021 consist primarily of royalties on sales under the license agreement signed with Acrotech. These revenues were used entirely to repay the bond loan granted by SWK Holdings, also denominated in dollars, which represents a natural currency hedge. The Company also works with U.S. subcontractors in its R&D operations. As it has not set up a currency hedging system, it is essentially exposed to the risk of an increase in the value of the U.S. dollar against the euro, which would increase the euro equivalent of its purchases in dollars.
In the future, the Company's exposure to foreign exchange risk may vary depending on:
The risks associated with the failure to develop a drug candidate are closely linked to the maturity stage of the drug candidate. Given the relatively early stage of the Company's most important drug candidates, respectively in Phase 1 for AsiDNA® and in the preclinical phase for OX401 as of the date of this Report, there is a significant risk that some or all of the Company's drug candidates may not be developed, formulated or produced under acceptable economic conditions, may have their development interrupted, may not be the subject of partnership or licensing agreements, may not obtain regulatory approval or may never be commercialized.
Onxeo is developing a novel therapeutic approach based on an agonist decoy mechanism of tumor DNA repair pathways, which could allow synergistic effect with other anti-cancer treatments and prevent or reverse tumor resistance to certain targeted therapies.
To date, however, no oligonucleotide agonists for tumor DNA repair pathways have been developed or approved for marketing in oncology by the relevant health authorities. The prospects for the development and profitability of Onxeo's most advanced drug candidate, the Company's ability to develop, formulate or produce it under economically acceptable conditions, its safety, efficacy and its acceptance by patients, healthcare prescribers and paying agencies are therefore still highly uncertain.
Given the highly innovative nature of the technology on which it is based, the results of AsiDNA® in Phase 1 trials, and more generally those relating to all existing or future drug candidates in the Company's portfolio or based on its technology in their research or preclinical phases, may or may not be confirmed by subsequent clinical trials. Such a situation would have a very significant adverse impact on the Company's business, results, financial position and prospects.
The development of a drug candidate is a long, costly and uncertain process aimed at demonstrating the therapeutic benefit of a drug candidate that competes with existing products or those under development.
The clinical development of our product candidates could be delayed, suspended or canceled due to a number of factors, including the following:
AsiDNA® in combination with niraparib in the REVOCAN study, which means that the potential patient population is limited;
Delays in clinical studies could also shorten the operating periods during which the Company's products are protected by patent(s) and allow its competitors to commercialize their products in the shorter term, which could adversely affect Onxeo's ability to license or successfully commercialize its drug candidates.
Onxeo plans to initiate new clinical trials with AsiDNA® in combination with other cancer treatments in indications of high unmet medical need, such as rare, advanced or relapsed cancers.
If a significant delay occurs in a trial and development times deviate significantly from estimates, the Company could be required to abandon the development of one or more of its product candidates and not be able to generate sufficient revenues through partnerships, which could have a negative impact on the Company's financial situation and development.
The "Covid-19" epidemic that began in the spring of 2020 slowed down most clinical trials that were not related to the diagnosis or treatment of this virus. The trials conducted and planned by the Company in 2022 are relatively small phase trials and concern patients with rare, advanced or relapsed cancers for which there is a significant medical need. However, if the health situation were to worsen in 2022, this could lead to a freeze or a significant slowdown in the conduct of trials, and this risk, already considered significant, would become major.
The risk of a serious side effect in a clinical trial or negative results from a clinical trial could affect Onxeo's growth.
As part of its research and development programs, the Company must conduct preclinical trials in animals and clinical trials in humans in order to demonstrate the safety and efficacy of its drug candidates.
Although the Company conducts its trials with the utmost care, in particular, in the definition of protocols, the use of expert partners and the study of competing products, events that could lead to the failure of a clinical development include:
Given the early stage of the Company's portfolio in the advanced field of DNA repair and the fact that only one product in this portfolio, AsiDNA®, has reached the stage of clinical development as of the date hereof, the Company's inability to successfully complete clinical trials of AsiDNA® could have a significant adverse effect on its ability to generate future revenues, its financial condition and its development.
Furthermore, promising results of the drug candidates AsiDNA® and OX401 during the initial preclinical and clinical phases, and even after advanced clinical trials, do not guarantee that any of the Company's drug candidates can be licensed out or successfully marketed and commercialized.
The combination of several treatments is commonly used for the treatment of cancer, especially for conditions that are difficult to treat and have a high unmet medical need. The Company is currently developing AsiDNA® and may develop other drug candidates in combination with one or more cancer treatments currently approved or under development.
The Company is currently conducting a Phase 1b/2 trial with AsiDNA® in combination with PARP inhibitors, the REVOCAN trial, in patients with relapsed ovarian cancer. AsiDNA® has also demonstrated in preclinical studies its ability to prevent resistance to KRAS and tyrosine kinase inhibitors, which could lead to further combination developments. AsiDNA® has also demonstrated its ability to sensitize tumors to radiotherapy in challenging indications and initiated a pediatric program in this combination with Institut Curie in early 2021. Finally, OX401, a next-generation PARP inhibitor that activates the immune system, could potentially be developed in combination with immune checkpoint inhibitors.
Despite the favorable safety profile to date of Onxeo's decoy agonist technology, patients may not be able to tolerate the combination of the Company's drug candidates with other therapies.
If one or more of the Company's drug candidates were to be developed or receive marketing approval or be marketed for use in combination with other existing treatments, Onxeo and its partners would remain exposed to the risks that the FDA, the EMA or other similar foreign regulatory authorities could withdraw approval of the treatment used in combination with any of the Company's drug candidates or that problems related to safety, efficacy, manufacturing or supply could arise with such existing treatments.
If these problems were to occur, the Company's strategy of leveraging its drug candidates in combination would be called into question, which would have a material adverse effect on the Company's ability to generate future revenues, its financial position and its development.
One of the major challenges for a growth company like Onxeo is to succeed in developing, with the help of partners, products integrating its technologies in the context of an increasingly restrictive regulatory environment. The pharmaceutical industry is faced with a permanent evolution of its legal and regulatory environment and increased surveillance by the competent authorities, in particular the National Agency for the Safety of Medicines and Health Products ("ANSM") in France. , the European Medicines Agency ("EMA") in Europe, or the Food and Drug Administration ("FDA") in the United States or other regulatory authorities in the rest of the world. Correlatively, the public demands more guarantees as to the safety and efficacy of drugs.
In particular, health authorities supervise research and development work, preclinical studies, clinical studies, the regulation of pharmaceutical establishments, as well as the manufacture and marketing of drugs. This strengthening of the legislative and regulatory framework is common throughout the world, although the requirements vary from one country to another. In particular, the health authorities and in particular the ANSM, the EMA or the FDA have imposed increasingly heavy requirements in terms of the volume of data requested in order to demonstrate the efficacy and safety of a product. These increased requirements have thus reduced the number of products authorized in relation to the number of files submitted. The products marketed are also subject to regular reassessment of the benefit/risk ratio after their authorisation. Late discovery of problems not detected at the research stage can lead to marketing restrictions, suspension or withdrawal of the product and an increased risk of litigation.
The authorization process is therefore long and costly, possibly taking several years, with an outcome that remains unpredictable.
To the extent that new legal or regulatory provisions increase the costs of obtaining and maintaining product marketing authorizations or limit the economic value of a new product for its inventor, the growth prospects of the pharmaceutical industry and the Company could be reduced.
Furthermore, health care providers, physicians and other stakeholders play a critical role in the clinical development, approval and, once obtained, recommendation and prescription of Onxeo's drug candidates. Its agreements with such persons and third-party payers, as well as its activities, could expose the Company to laws and regulations with a broad scope of application with respect to fraud and abuse, as well as other laws and regulations relating to health care, which could limit the commercial or financial agreements and relationships through which the Company researches, develops and, when authorizations are obtained, markets or distributes its products.
For example, the U.S. Physician Payments Sunshine Act, similar state or foreign laws and regulations, such as state "anti-gift" laws and laws relating to false claims, the "Bertrand Act" in France (Law No. 2011--2012 of December 29, 2011), require relevant manufacturers of covered drugs to periodically monitor and report contracts, payments and other transfers of value to physicians and certain property rights and investments held by physicians or their immediate family members or health care professionals.
In addition, the Company may collect, process, use or transfer personal data from persons located within the European Union in the course of its activities, in particular health data, in the context of clinical trials conducted within the European Union. A significant portion of the personal data that the Company may use could be managed by third parties (mainly CROs in connection with clinical trials). The collection and use of personal health data within the European Union is governed by the provisions of the General Data Protection Regulation (EU) 2016/679 (GDPR). Failure to comply with the requirements of the GDPR and the national laws of the Member States of the European Union relating to data protection, including data managed by third parties, for which the Company is unable to ensure compliance with the GDPR, may result in substantial fines, other administrative sanctions and civil actions against the Company, which could have a material adverse effect on its business, prospects, financial condition and results of operations.
The market for biotechnology and pharmaceuticals, including oncology, is characterized by rapidly changing technologies, products protected by intellectual property rights and intense competition, and is subject to significant and rapid change as researchers learn more about diseases and develop new technologies and treatments.
Onxeo faces potential competition from many different sources, including large pharmaceutical and biotechnology companies, academic institutions and government agencies, as well as public and private research institutes. All drug candidates that the Company or its partners will successfully develop will compete with existing treatments and new treatments that may become available in the future.
If competing products are marketed ahead of the Company's products, or at lower prices, or cover a broader therapeutic spectrum, or are found to be more effective or better tolerated, sales of the Company's products would be adversely affected. Although some of the Company's products are "first-in-class" due to their mechanism of action, many companies are targeting tumor DNA repair pathways and have drug candidates in clinical development, in particular large international pharmaceutical companies.
Many of the competitors developing cancer treatments have resources and experience significantly greater than the Company's in research, access to patients for clinical trials, drug development, financing, manufacturing, marketing, technology and personnel. In particular, large pharmaceutical companies have much more experience than Onxeo in conducting clinical trials and obtaining regulatory approvals.
The analysis of the competitive environment in DDR highlights two companies that are very involved in this field: AstraZeneca and Merck KGaA, with products that are either approved or in advanced development in most of the major inhibitor families in this therapeutic area. Many smaller biotechnology companies, such as Artios Pharma, Repare Therapeutics and Impact Therapeutics, have a strong specialization in this field.
Mergers and acquisitions in the pharmaceutical, biotechnology and diagnostics industries may result in an even greater concentration of resources on a smaller number of competitors. Small or start-up companies can also be important competitors, particularly through collaborative arrangements with large, wellestablished companies.
The Company may also face competition to acquire rights to promising drug candidates and other complementary technologies, to establish clinical trial sites and compete with the Company in enrolling patients for clinical trials and acquiring technologies that are complementary or necessary for its programs, as well as to enter into collaborations with partners having access to innovative technologies.
In addition, the Company's marketed products could be subject to competition through the introduction on the market of comparable drugs, and/or upon expiration of their protection by property rights or market exclusivity, the development of generics, which would result in a decrease in prices and/or sales volume and could have an adverse effect on the Company's business and financial condition.
If the Company is unable to compete successfully with new or existing products, its ability to generate revenues from licensing agreements would suffer and it may never be profitable.
The Company's profitability depends primarily on its ability to enter into collaboration or licensing agreements for its drug candidates with industrial partners, which generate upfront and milestone payments and royalties on sales, after market authorization. Indeed, the Group's strategy favors the conduct of advanced phases of clinical development (particularly phase 3 studies) and the commercialization of its products via partners, rather than directly, given the Group's current structure and the costs in time, energy and financial and human resources required for these activities.
The conclusion of such agreements is the result of negotiations that are often long and complex and could be delayed or called into question by numerous factors, including macroeconomic, political and competitive factors, or by failures or delays in the development of the Company's products.
The Group cannot guarantee that, when the time comes, it will be able to identify a suitable partner or enter into a partnership on the most favorable commercial terms for it. The Company's inability to enter into agreements with one or more partners to pursue the development of its drug candidates would have a material adverse effect on its ability to generate future revenues, its financial position and its development.
Moreover, once these partnerships are entered into, the Company cannot guarantee that they will be profitable for the Group. Even if the Group were able to establish a relationship of trust with partners, it has limited control over them. These partners could call into question or be in default in the performance of their obligations, not devote sufficient time or effort to the proper performance of the Group's activities or favor their interests or those of other partners over those of the Group. Thus, insufficient performance by a current or future partner could slow down product development and thus delay or limit revenues from milestone payments or royalty payments on sales of the Company's products.
The Company's ability to successfully commercialize its products will depend on its ability to obtain, maintain and protect its intellectual property rights. As of the date of this Management Report, the Company has rights to two hundred and forty-nine patents or published patent applications, of which one hundred and seventy-nine, or 72%, have been granted in several major jurisdictions or countries, including the United States, Europe, China and Japan.
In the pharmaceutical field, patent law (articles of law, implementing regulations, case law, etc.) continues to evolve and presents uncertainties. In particular, no uniform global policy has so far emerged on the content of patents granted in the fields of biotechnology or on the scope of permitted claims. Thus, for example, patents may be granted with claims of variable/different scope from one territory to another.
Although the Company implements a proactive "intellectual property" strategy, directly related to its research and development projects, both with respect to the detection of inventions, in order to multiply protection, and with respect to monitoring third-party publications and patent procedures, it cannot, however, guarantee:
If one or more of these circumstances were to occur, the Company could face significant costs to enforce its rights, could be required to significantly challenge the development strategy of its drug candidates or existing or future partnership agreements, which could have an adverse or negative impact on the Company's business and financial condition.
The Company operates in compliance with applicable laws and regulations, with the support of its internal legal team and law firms. However, legal proceedings could be instituted against the Company by competitors, industrial or commercial partners, subcontractors or other third parties in the course of its activities.
As of the date of this Management Report, there are no governmental, legal or arbitration proceedings, including any proceedings of which the Company is aware, which are pending or of which the Group is threatened, that are likely to have or have had in the past 12 months a significant effect on the Group's financial situation or profitability.
However, it cannot be excluded that legal proceedings may be initiated against the Company. In particular, it may be held liable for the damaging and/or wrongful conduct of its employees, collaborators, service providers or partners. Even if such legal proceedings would not result in a conviction to the detriment of the Company, these proceedings, and the time and resources required to resolve them, may force the Company to use resources that should have been allocated to the Company's business. It could also damage the Group's reputation.
The Company has purchased liability insurance. However, if the costs or expenses associated with this or any other litigation exceed its insurance coverage, the Company may be required to directly assume all or part of the costs. If, ultimately, the Company were to pay significant defense costs and/or damages, these payments could have an adverse effect on its business.
The completion of any investment (i) by (a) an individual of foreign nationality, (b) any individual of French nationality not domiciled in France within the meaning of article 4B of the French General Tax Code, (c) any entity governed by foreign law, and (d) any entity governed by French law controlled by one or more of the entities referred to in (a) to (c), (ii) which would result in (a) the acquisition of control - within the meaning of article L. 233-3 of the French Commercial Code - of a French company, (b) acquiring all or part of a branch of activity of a French company, or (c) for individuals who are not nationals of a Member State of the European Union or of a State party to the Agreement on the European Economic Area that has entered into an administrative assistance agreement with France and/or are not domiciled in one of these States, or for legal entities of which at least one of the members of the control chain is not subject to the law of one of these States or is not a national and/or is not domiciled there, to cross the threshold of 10% of the voting rights of a French company and (iii) whose activities relate, even occasionally, to the research and development of socalled critical technologies, such as biotechnologies, and considered essential to the protection of public health, is subject to prior authorization by the Minister of the Economy.
If an investment in the Company that requires the prior authorization of the Minister of the Economy is made without such authorization having been granted, the Minister of the Economy may cancel the transaction or order (possibly under penalty) the investor concerned (i) to submit an application for authorization, (ii) to have the previous situation restored at its own expense or (iii) to modify the investment. In addition, the Minister may impose undertakings and conditions on the investor (including regular reporting commitments). The investor concerned could also be declared criminally liable and be sanctioned, in particular, by exclusion from all public contracts or by a fine that may not exceed the highest of the following three amounts: (i) twice the amount of the relevant investment, (ii) 10% of the Company's annual pre-tax revenues and (iii) 5 million euros (for a company) or 1 million euros (for an individual).
The application of these regulations is likely to constitute a potential barrier to investments made by investors located outside the European Economic Area and could therefore limit access to financing sources for the Company. It is also difficult to predict whether this regulation will have an impact on the volatility of the Company's share price.
Due to its structure and size, Onxeo relies on third parties located in France and abroad to conduct its activities, in particular for the manufacture of its products and for the preclinical and clinical trials it conducts. The Company may therefore be dependent on its subcontractors and service providers:
- As regards preclinical and clinical trials, the quality of the trial results depends in particular on the quality of the services expected and their compliance with the specifications initially set and with the applicable standards. The failure of a subcontractor involved in a preclinical or clinical trial, loss of data, data processing delays or errors could adversely affect the validity of the trials and the compilation of regulatory files for the Company's products under development.
Some of our clinical trials are conducted through research collaborations with renowned centers, such as the REVOCAN trial and the AsiDNA® Children's trial sponsored by Gustave Roussy and the Curie Institute respectively, and other collaborations of this type may be initiated in the future. These collaborations allow us to benefit from undeniable expertise and an external validation of the clinical value of these studies, but imply a very limited control of the Company over their conduct, in particular in terms of the pace of recruitment and the allocation of resources, including in terms of the time devoted to our drug candidates and our clinical trials, in particular during a health crisis related to Covid. The Company is therefore dependent on the sponsors to obtain the results of these trials, the communication of which to the market may be significantly delayed compared to the initial estimates.
- With respect to the manufacturing of products under development, the unavailability of subcontractors to carry out a project or their failure to do so could have an adverse effect on the development of products, their availability or their compliance, thereby affecting the conduct of tests or procedures concerning them and, ultimately, the Company's ability to generate future revenues, its financial position and its development.
This risk is particularly sensitive to health and geopolitical risks, especially with respect to clinical trials (see paragraph 2.2.4 of the management report) and production operations. A worsening of the health crisis situation in 2022 as well as a continuation or extension of economic sanctions in the context of the Russian-Ukrainian conflict could significantly increase this risk.
The Company may not be able to retain its key personnel and attract the new employees it will need for its development.
The Company's success depends largely on the work and expertise of its senior management and key personnel. The temporary or permanent unavailability of these key persons could impair the Company's ability to achieve its research, development and marketing objectives, in particular by depriving it of their know-how and technical capabilities and could seriously harm the Company's ability to successfully implement its business strategy, even though the Company has taken out a "key person" insurance policy covering the risk of bodily injury to its executives.
In addition, the Company will need to recruit new senior managers and qualified scientific personnel for the development of its activities, particularly in areas requiring expertise that it does not have in-house. The Company competes with other companies, research organizations and academic institutions to recruit and retain highly qualified scientific, technical and management personnel. To the extent that this competition is very intense, the Company may not be able to attract or retain the required key personnel on economically acceptable terms.
In its laboratory, the Company may use hazardous chemicals and biological materials in the course of its business and any claims relating to improper handling, storage or disposal of these materials could be timeconsuming and costly.
Research and development processes involve the controlled use of hazardous materials, including chemical, biological and radioactive products. Onxeo cannot eliminate the risk of accidental contamination or release and any injury resulting from accidental exposure to these materials.
The Company also processes genetically recombinant material, genetically modified species and pathological biological samples. Consequently, in France and in the countries where the Company operates, it is subject to environmental and safety laws and regulations governing the use, storage, handling, release and disposal of hazardous materials, including chemical and biological products and radioactive materials.
The Company imposes preventive and protective measures for the protection of its personnel and waste control management, in accordance with applicable laws. If Onxeo or any of its partners fail to comply with applicable regulations, the Group could be subject to fines and be required to suspend all or part of its activities.
Compliance with environmental, health and safety regulations entails additional costs, and the Company could incur significant costs to comply with future laws and regulations in the relevant jurisdictions. Compliance with environmental laws and regulations may require the Company to purchase equipment, modify facilities and incur significant expenditures. The Company could be held liable for any inadvertent contamination, injury or damage that could harm its business and reputation, although Onxeo has taken out an insurance policy covering certain risks inherent in its business.
To date, the Company is not aware of any pending litigation.
The annual financial statements of the Company that we are submitting for your approval have been prepared in accordance with the presentation rules and valuation methods provided for by the regulations in force.
During the year ended December 31, 2021, the Company generated revenues of 46 thousand euros, compared with 489 thousand euros for the year ended December 31, 2020. This change is mainly due to the direct sales of Beleodaq® under the European controlled access program (NPP), which were recognized until this business was transferred to Acrotech under the licensing agreement signed in early April 2020.
Other operating income totaled 5,496 thousand euros, compared with 9,396 thousand euros recorded in 2019. This item mainly includes royalties on the sales of Beleodaq under the license agreement with Acrotech for an amount of 1,860 thousand euros. It also includes a reversal of the provision for impairment of the subsidiary Topotarget Switzerland's current account in the amount of 3,602 thousand euros, as a result of the receipt of license revenues (Biogen) by this subsidiary, which have improved its net position.
Operating expenses are difficult to compare due to the full amortization of the Beleodaq® R&D assets for an amount of 2,441 thousand euros in fiscal year 2020, as a result of the agreement with Acrotech. Excluding this specific item, operating expenses are broadly stable, rising from 11,125 thousand euros in 2020 to 11,088 thousand euros in 2021. Research and development expenses incurred in 2021 amounted to 4,899 thousand euros, compared to 3,923 thousand euros the previous year, this increase being mainly related to the clinical development of AsiDNA as well as the optimization and preclinical development of OX400 family compounds.
The operating result showed a loss of (5,547) thousand euros, compared with a loss of (3,682) thousand euros in fiscal 2020.
The financial result showed a loss of (508) thousand euros, compared with a loss of (586) thousand euros in fiscal 2020. This loss is mainly due to the interest expense of 847 thousand euros related to the bond issue with SWK Holdings.
Income from ordinary activities before taxes showed a loss of (6,054) thousand euros compared with a loss of (4,269) thousand euros for fiscal year 2020.
The extraordinary result is a loss of (23) thousand euros.
The Company recognized a research tax credit of 1,745,000 euros for the year ended December 31, 2021, of which 1,717,000 euros was in France and 27,000 euros in Denmark.
As a result of these various income and expense items, net income for the year showed a loss of (4,332) thousand euros, compared with a loss of (3,566) thousand euros for fiscal 2020.
We propose that the loss for the year of 4,332,479 euros be allocated in full to the "Retained Earnings" account, which would thus be increased from a debit of 12,913,165 euros to a debit of 17,245,545 euros.
In accordance with the provisions of Article 243 bis of the French General Tax Code, we remind you that no dividend was distributed in the last three financial years.
In accordance with the provisions of Articles 223 quater of the French General Tax Code, we inform you that no non-tax-deductible expenses were incurred during the year under review.
In addition, no overheads referred to in Articles 39--5 and 223 quinquies of the French General Tax Code that are not included in the special statement were incurred.
A table showing the Company's results for the last five years is attached to this report in Appendix I, in accordance with Article R. 225--102 paragraph 2 of the French Commercial Code.
In accordance with the provisions of Article L. 233--6 of the French Commercial Code, we inform you that the Company has not acquired any interest in a company with its registered office in France during the past fiscal year.
Art. L. 511--6, 3 bis al. 2 and R. 511-2--1--1 and R. 511-2--1-2 of the French Monetary and Financial Code None.
In accordance with the provisions of Article L. 441--6--1 of the French Commercial Code, the table below shows the payment terms of the Company's suppliers and customers for the last two years.
| Article D.441 I-1°: invoices received but not paid at the closing date of the | Article D.441 I-2°: invoices issued but not paid at the closing date of the financial | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| financial year for which the term is due | year for which the term is due | |||||||||||
| 0 days | 1 to 30 | 31 to 60 | 61 to 90 | 91 days | Total (1 day | 0 days | 1 to 30 | 31 to 60 | 61 to 90 | 91 days | Total (1 day | |
| days | days | days | and over | and over) | days | days | days | and over | and over) | |||
| (A) Late payment brackets | ||||||||||||
| Number of | ||||||||||||
| invoices | 67 | 62 | 1 | 0 | ||||||||
| concerned | ||||||||||||
| Total amount of | ||||||||||||
| the invoices | 181,537 | 71,668 | 418 | 10,726 | 13,896 | 96,708 | 756 | 0 | 0 | 0 | 0 | 0 |
| concerned | ||||||||||||
| including VAT. | ||||||||||||
| Percentage of | ||||||||||||
| total purchases | 1.9% | 0.8% | 0% | 0.1% | 0.1% | 1.0% | ||||||
| including VAT for | ||||||||||||
| the year | ||||||||||||
| Percentage of | ||||||||||||
| sales including | 0,0% | 0,0% | 0,0% | 0,0% | 0,0% | 0,0% | ||||||
| VAT for the year | ||||||||||||
| Number of | ||||||||||||
| excluded invoices | 0 | 0 | ||||||||||
| Total amount of | ||||||||||||
| excluded invoices | 0 0 |
|||||||||||
| (C) Reference payment deadline used (contractual or legal deadline—Article L. 441--6 or Article L. 443--1 of the French Commercial Code) | ||||||||||||
| Payment terms | ||||||||||||
| used to calculate | ▪ Contractual deadlines: Each invoice is followed with its own contractual |
▪ Contractual deadlines: Each invoice issued is followed with its own contractual |
||||||||||
| late payments | deadline. This deadline usually varies from 20 to 30 days end of the month. | deadline. This deadline is 30 days end of month for sales of goods and 45 to 60 | ||||||||||
| days for other services depending on the contract. |
Onxeo group's consolidated financial statements, which we are submitting for your approval, have been prepared in accordance with International Financial Reporting Standards (IFRS).
The consolidated financial statements show revenues of 4,062 thousand euros compared with 1,776 thousand euros in 2020. This change is mainly due to the recognition of flat-rate royalties owed by Biogen under a licensing agreement for a non-strategic product, in the amount of 3,829 thousand euros, which are classified as non-recurring revenues. In parallel, recurring revenues are decreasing due to the license agreement concluded in April 2020 for the product Beleodaq (belinostat). This agreement, which extended the partner Acrotech Biopharma's marketing rights to the product in return for a one-time payment of \$6.6 million on signature, was considered as a disposal under IFRS insofar as it gave the partner control over the asset concerned, and led to the recognition of all expenses and revenues relating to Beleodaq in fiscal year 2020. This accounting treatment explains the absence of recurring revenue from Beleodaq in 2021, given that the amount of 1,077 thousand euros in 2020 corresponded to revenue from this product in the period prior to the signature of the agreement with Acrotech.
The operating expenses are stable overall, rising from 9,803 thousand euros in 2020 to 9,722 thousand euros in 2021. However, the Group's R&D expenses have increased from 3,946 thousand euros in 2020 to 4,904 thousand euros in 2021, in particular due to the industrial development of AsiDNA and the preclinical development of OX400 family compounds.
The significant change in other non-recurring operating income and expenses is due to the recognition of the license agreement with Acrotech in 2020, which led to the recognition of the following amounts:
The financial result is a loss of 693 thousand euros, which is mainly due to the interest expense related to the bond issue with SWK Holdings.
After taking into account these various items of income and expense as well as net tax expense of 100 thousand euros, the net result is a loss of 5,937 thousand euros compared to a profit of 1,089 thousand euros recorded in the previous fiscal year.
The contribution of the consolidated companies to the overall result is as follows:
We submit these financial statements for your approval (Articles L. 225--100, L. 233--16 and R. 225--102 of the French Commercial Code).
The Group had cash and cash equivalents of 17.9 million euros at the end of the fiscal year. Given the 12 million euros financing received in April 2022 from its two main shareholders, Invus and Financière de la Montagne, the Company can finance its activities at least into Q2 2023 based on its financing plan.
The Group has contracted a financial debt in the form of bonds issued to SWK Holdings, the balance of which amounted to 2.8 million euros at the end of 2021 (corporate accounts). The repayment of this debt will be made through royalties on sales of Beleodaq® paid by the American partner Acrotech Biopharma.
Onxeo also has public reimbursable grants of 164,000 euros, relating to the AsiDNA® and OX401 projects, which will be fully repaid by 2025.
In 2022, the Company will pursue its value creation strategy based on the development of its therapeutic innovations up to proof of concept in humans, with the following main steps:
- Continued evaluation and optimization of new compounds.
Onxeo also intends to rely on the recommendations of the members of its Scientific Advisory Board, which is made up of opinion leaders from international teams that specialize in areas of interest to the Company, to enrich its development programs.
Onxeo believes that, given its current activities, it has no further comments to make on trends that could affect its recurring revenues and general operating conditions from the date of the last fiscal year ended December 31, 2021 to the date of publication of this report.
We inform you that our Company has not carried out any of the transactions provided for in Articles L. 233-- 29 and L. 233--30 of the French Commercial Code.
We remind you that, in accordance with the provisions of Articles L. 225--209 et seq. of the French Commercial Code, the Company has been authorized by its shareholders to trade in its own shares, up to a maximum of 10% of the share capital. This authorization was granted for a period of eighteen months by the Company's Ordinary Shareholders' Meeting of May 29, 2020 under the terms of its fifteenth resolution, and then renewed for a period of eighteen months by the Company's Ordinary and Extraordinary Shareholders' Meeting of June 10, 2021 under the terms of its eighth resolution.
During the year ended December 31, 2021, the Board of Directors successively implemented the program authorized by the Shareholders' Meeting of May 29, 2020 and, as of June 11, 2021, the program authorized by the Shareholders' Meeting of June 10, 2021, which is identical to the previous one.
The objectives of this buyback program concern, in decreasing order of priority, the following situations:
The description of this share buyback program is available at the Company's headquarters and on its website.
In accordance with the provisions of Article L. 225--211 of the French Commercial Code, we hereby report to you on the implementation of the share buyback program during the past year.
During fiscal year 2021, the share buyback program was used exclusively within the framework of a liquidity contract with the objective of stimulating the secondary market or the liquidity of the Company's shares, by an investment services provider.
On January 2, 2007, the Company entered into a liquidity agreement with CM-CIC Securities in accordance with the code of conduct of the French Financial Markets Association (AMAFI), which is recognized by the Autorité des Marchés Financiers (AMF), in compliance with the regulations in force, and in particular the provisions of European Regulation 2273/2003 of December 22, 2003.
Onxeo has then entrusted Kepler Cheuvreux with the implementation of a liquidity contract for its ordinary shares, effective December 3, 2018 for a period of twelve months, and renewable by tacit agreement. This contract complies with the code of ethics of the Association Française des Marchés Financiers ("AMAFI").
For the implementation of this contract, 87,612 shares and 196,423 euros in cash were allocated to the liquidity account. The negotiation costs for this contract amount to 25,000 euros per year.
Under the liquidity contract entrusted by ONXEO to Kepler Cheuvreux, as of December 31, 2021, the following resources were included in the liquidity account:
The 429,850 bearer shares held in treasury at December 31, 2021, with a par value of 36,891.92 euros, represented 0.47% of the capital and were valued at 180,537 euros at the share purchase price.
During the 2nd half of 2021, a total of:
| BUY | 357,510 securities | €179,383.26 | 256 transactions |
|---|---|---|---|
| SALE | 221,580 securities | €115,071.34 | 155 transactions |
As a reminder, at the time of the last half-yearly balance sheet as of June 30, 2021, the following resources were included in the liquidity account:
| BUY | 225,004 securities | € 157,757.98 | 122 transactions |
|---|---|---|---|
| SALE | 203,522 securities | €148,483.15 | 118 transactions |
In accordance with the requirements of Article 2 of AMF Decision No. 2018-01, the half-yearly and annual reports on the liquidity contract are available on the Company's website
As of December 31, 2021, the Company did not hold any treasury shares.
Sales of treasury shares under the liquidity contract generated a net capital loss of 74,463 euros in the year ended December 31, 2021.
In accordance with Article L. 225--102 of the French Commercial Code, we inform you that as of December 31, 2021, the Company's employees and officers did not hold any interests in the Company's share capital under collective management.
To the best of the Company's knowledge, as of December 31, 2021, 569,723 shares representing 0.62% of the share capital were held directly by employees or corporate officers in accordance with Article L. 225-197-1 of the French Commercial Code.
In accordance with the provisions of Article L. 621-18-2 of the French Monetary and Financial Code, we hereby inform you of the transactions in the Company's shares (acquisitions, sales, subscriptions or exchanges of shares) carried out by the Company's officers or members of the Board of Directors, or persons with whom they have close personal ties, to the best of the Company's knowledge, during fiscal year 2021.
| Persons concerned | Nature of the transaction |
Date of the transaction |
Number of shares |
Amount of the transaction (€) |
|
|---|---|---|---|---|---|
| Financière de la Montagne SARL, Director |
Subscription to the capital increase by issuing new shares |
4/16/2021 | 4,225,352 | 2,999,999.9 | |
| Invus Public Equities, Director | Subscription to the capital increase by issuing new shares |
4/16/2021 | 5,633, 803 | 4,000, 000 |
The risk management process and risk mapping are adjusted and assessed on an ongoing basis by senior management and department heads and are presented at least annually to the Audit Committee as part of its task of monitoring and controlling the effectiveness of internal control and risk management systems.
The Group has adopted a procedure designed to provide a framework for all the risk management methods and tools used and which specifies the terminology adopted within the Group (probability and severity criteria, risk typology and ranking, etc.).
The objectives of this risk management policy are essentially to preserve the Group's assets and image, minimize its costs and promote the achievement of its strategic objectives.
In order to identify and assess the risks that could have an adverse impact on its business, prospects, financial situation, results (or its ability to achieve its objectives) and development, the Company has mapped the risks associated with its business periodically, at least once a year. This has allowed for the identification of potential risks and the assessment of their likelihood of impact and, where possible, their potential impact from a financial, legal and reputational perspective, as well as on the achievement of the Company's objectives. It then allowed for the identification and evaluation of ways to control these risks.
Risk mapping is a management tool. The risk management process and risk mapping are presented annually to the Audit Committee as part of its task of monitoring and controlling the effectiveness of internal control and risk management systems.
At the time of the periodic risk review, all risks and mitigation measures are reviewed and reassessed. This tool is also supplemented by a detailed analysis of the causes and impacts in the event of the occurrence of any significant risk and accounts for the actions and control measures put in place by the Company. This methodology should provide an overview of the risk environment affecting the Company and should allow it to define, if necessary, a risk management plan that specifies the actions to be taken, the persons responsible, the stakeholders, the deadlines to be met, the budget associated with each action as well as the areas of control and internal audits for the coming year.
For each of the identified risks, the potential impact in terms of financial impact, lost workdays, impact on the company's activity and on its image are analyzed, and a probability index and a criticality index are assigned from which a coefficient combining these two criteria is deduced.
The risks are then classified in order of decreasing importance, which allows them to be categorized according to the following typology: major risk, strong risk or acceptable risk.
Every major risk is the subject of a risk management plan that specifies the actions to be taken, the persons responsible, the stakeholders, the deadlines to be met, and the budget associated with each action.
The significant risk factors to which the Company considers itself exposed are presented in section 2 of the Management Report.
The Company has insurance coverage that is adapted to its activities worldwide, and in particular for its clinical trials in France, the United States and all other countries concerned.
The Company has taken out several insurance policies, the main ones being the following:
The definition of the insurance policy is part of a concern for efficiency, both in the negotiation and in the management of the policies. In view of the development and internationalization of the Group's activities, the risk management policy should be continued, in close coherence with the evolution of our activities.
The purpose of risk management is to identify and analyze the main risks and risk factors that may affect the company's activities, processes and objectives, and to define the means that allow for these risks to be maintained at an acceptable level, in particular by putting in place preventive measures and controls that fall under the internal control system.
At the same time, the internal control process relies on risk management to identify the main risks to be controlled.
Internal control comprises a set of resources, behaviors, procedures and actions that are adapted to the specific characteristics of each company and of the group as a whole, which:
The purpose of internal control is to ensure:
However, while internal control promotes the achievement of the Company's objectives, it cannot provide an absolute guarantee that they will be achieved. There are inherent limitations to any internal control system, such as the uncertainties of the external environment, the exercise of judgment, or the cost/benefit ratio of implementing new controls.
Onxeo continues to develop its internal control process based on the AMF reference framework and its application guide in its updated version of July 22, 2010. This process applies to the general organization of the operational departments and to the risk management procedures implemented by the Company.
The Group's internal control system is implemented by taking into account both the Group's operational functioning and its legal structure.
It concerns all fully consolidated subsidiaries of the Group.
The summary information on the internal control procedures implemented described in this report focuses on the significant elements likely to have an impact on the financial and accounting information published by the Company.
The internal control system is based on a clear organization of responsibilities, guidelines, resources and procedures.
Since the Company's inception, Onxeo has had a quality assurance system. The processes in all areas of activity are described by procedures (Standard Operating Procedures or SOPs), operating modes, notices and forms. These written documents trace the progress of activities, define the resources and responsibilities of those involved, specify the Company's know-how and give precise instructions for performing a given operation.
All the Company's stakeholders are involved in the internal control system.
Onxeo, which is established in the health and biotechnology sector, is subject to very specific regulations that govern its activities, and compliance with which is also the subject of internal control. Legislative and regulatory provisions, defined by the European Commission and the equivalent regulatory authorities in other countries, in particular the French National Agency for the Safety of Medicines (ANSM), the European
Medicines Agency (EMA), and the Food and Drug Administration (FDA), provide a framework for research and development studies, preclinical studies, clinical studies, the regulation of establishments, as well as the manufacture and marketing of medicines. The main regulatory texts that apply to the Company's activity are the following: Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), French and European regulatory texts that apply to the development and use of drugs, regulatory texts on GMOs, waste disposal, transport of hazardous products, handling of micro-organisms, hygiene and safety.
The control activities implemented by the Company are supported by a number of internal players and various tools, including a document system that describes the key processes and controls.
Internal control is implemented by the management bodies and by all Group employees through their daily actions.
Internal stakeholders involved in the internal control system include:
These provisions are supplemented by the involvement of external stakeholders, including the statutory auditors. The latter rely in particular on a review of the internal control procedures relating to the preparation of accounting and financial information in the context of their statutory mission to certify or audit the consolidated and individual financial statements of Group companies.
All documentation relating to the internal control system is recorded on a dedicated intranet that allows for optimal access to documents and their permanent adaptation to changes in the business (document life cycle management). The objective is to continuously improve the quality of the Company's and the Group's operating processes, whether they be operational, management or support processes.
The internal control system covers the following areas in particular:
objectives are the validation of all experimental protocols and the monitoring of compliance with regulations;
The Company continues to improve its internal control systems and regularly reviews its risk mapping and the action plans identified within its various departments in order to consolidate the management system put in place in previous years.
Under the applicable laws, regulations and bylaws, the Board of Directors must be composed of at least three and no more than eighteen members, appointed by the Shareholders' Meeting for a three-year term.
The Board of Directors is free to decide how to exercise the general management of the Company. This responsibility may be assumed by the Chairman of the Board of Directors himself, or by another individual appointed by the Board of Directors and bearing the title of Chief Executive Officer.
As of the date of this report, the Board of Directors is composed of nine members, out of which six are independant:
| First Name, Last Name, Title | Independent Director |
Year of 1st appointment |
Term Expiry Date |
Audit Committee |
Compensation & Appointments Committee |
Scientific Committee |
|---|---|---|---|---|---|---|
| Ms. Shefali Agarwal | Yes | 2021 | 2024 | Member | ||
| Ms. Danièle Guyot-Caparros | Yes | 2013 | 2022 | Chair | ||
| Ms. Judith Greciet | Yes | 2011 | 2023 | |||
| Invus Public Equities LP, represented by Mr. Julien Miara, |
No | 2020 | 2022 | Member | ||
| Financière de la Montagne, represented by Mr. Nicolas Trebouta |
No | 2011 | 2023 | Member | ||
| Mr. Robert Coleman | Yes | 2021 | 2023 | Chair | ||
| Mr. Bryan Giraudo | Yes | 2021 | 2024 | Member | Member | |
| GammaX Corporate Advisory, represented by Mr. Jacques Mallet |
Yes | 2021 | 2022 | Chair | Member | |
| Mr. Julien Miara | No | 2022 | 2025 |
The members of the Board bring together a wealth of expertise and enrich the studies and deliberations of the Board and its specialized committees with their varied experience in their field of expertise, particularly in the fields of healthcare and biotechnology companies. They are concerned with the interests of all shareholders and are fully involved in the deliberations in order to participate effectively in the Board's decisions and support them validly.
The Board of Directors is responsible for determining the strategic, economic and financial orientations of the Company and the Onxeo Group. It ensures their proper implementation.
Subject to the powers expressly granted by the shareholders' meetings and within the limits of the Company's corporate purpose, the Board deals with all matters relating to the proper operation of the Company and settles, through its deliberations, all matters that concern it, in particular all strategic decisions of the Company and the Group, on the initiative of its Chief Executive Officer.
The internal regulations, which are available to shareholders at the headquarters and also on the Company's website www.onxeo.com, determine the mission of the Board and the committees and organize their studies.
It specifies the Board's mode of operation and the procedures for implementing the legal requirements and statutory provisions concerning its role in the management of the Company and the Group. It also indicates the rights and duties of the members of the Board of Directors, mainly with regard to the prevention of conflicts of interest, the holding of multiple offices, the strict confidentiality of its deliberations and the diligence required to participate in Board studies. Finally, it deals with the rules relating to transactions in Onxeo shares, as recommended by the Autorité des Marchés Financiers.
To allow for the full exercise of the Board of Directors' mission, the bylaws state:
In the interest of transparency and public information and in order to comply with the requirements of Article L. 225-37-4 of the French Commercial Code, the Company has designated the Corporate Governance Code as it has was published, in its revised version, in September 2021 by MiddleNext (the "MiddleNext Code") as a reference code, this code being available in particular on the MiddleNext website: www.middlenext.com.
The table below presents the Company's position with respect to all the recommendations set forth in the Corporate Governance Code.
| MiddleNext Code Recommendations | Compliance |
|---|---|
| R1 - Board member Ethics | Yes |
| R2 - Conflicts of Interest | Yes |
| R3 - Composition of the Board - Presence of independent members | Yes |
| R4 - Board member information | Yes |
| R5 - Board member training | No |
| R6 - Organization of Board and Committee meetings | Yes |
| R7 - Establishment of committees | Yes |
| R8 - Establishment of a specialized committee on social/societal responsibility and environmental issues (CSR) |
No |
| R9 - Establishment of the Board's rules of procedure | Yes |
| R10 - Choice of each Board member | Yes |
| R11 - Board member term of office | Yes |
| R12 - Board Member remuneration | Yes |
| R13 - Implementation of an assessment of the Board's work | Yes |
| R14 - Relationship with shareholders | Yes |
| R15 - Diversity and equity policy within the company | Yes |
| R16 - Definition and transparency of the remuneration of executive directors | Yes |
| R17 - Officer succession planning | Yes |
| MiddleNext Code Recommendations | Compliance |
|---|---|
| R18 - Combination of employment contract and corporate office | Yes |
| R19 - Severance benefits | Yes |
| R20 - Supplementary pension plans | Yes |
| R21 - Stock options and free share grants | Yes |
| R22 - Review of Vigilance Points | Yes |
The following clarifications have been made with regard to the implementation of the various recommendations:
The rules of ethics that the directors undertake to respect (in particular confidentiality, independence and diligence) are clearly set out in the internal rules of the Board of Directors.
To date, the Board of Directors is not aware of any potential conflicts of interest.
The Board of Directors is composed of 6 independent directors out of a total of 8 members at the date of the prospectus. They are considered as independent with regard to the 5 criteria defined by the Middlenext code.
The procedures for issuing information to directors are described in Article 2 of the internal regulations.
The Company has integrated into its board of directors experts in the biotechnology sector, able to actively advise the Company on its strategy and the execution of its operational plan. As a result, it has not put in place a specific training plan, but it nevertheless organizes for each new member of the Board an integration course aimed at bringing him/her to meet all the executive directors and to transmit to him/her the specificities of Onxeo. The Board also appointed among its members a senior independent director in the person of Ms. Danièle Guyot-Caparros. This director ensures that the Company complies at all times with the good governance practices that apply to it, particularly with regard to French regulations. Her role is to assist the Board in ensuring the proper functioning of the Company's governance bodies and to advise it on the transactions on which the Board is called upon to deliberate.
Article 3 of the rules of procedure sets out the procedures for the organization of Board meetings, which must take place at least once every quarter and be recorded in minutes, as specified in Article 4 of the said rules.
The Board of Directors has set up 3 specialized committees: an Audit Committee, a Remuneration and Nomination Committee and a Scientific and Business Development Committee.
Given the small size of the Company, it did not consider it necessary to set up an ad hoc committee. CSR issues are handled directly by the Board of Directors. As lead director ("senior independent director"), Ms. Danièle Guyot-Caparros also oversees the monitoring of CSR topics.
The rules of procedure can be consulted on the Company's website www.onxeo.com and are available to shareholders at the registered office. These rules of procedure include the eight headings defined by the Middlenext code.
A detailed information sheet on each candidacy is posted on the Company's website before the General Meeting of Shareholders that decides on the nomination of a director.
The term of office is 3 years. The dates of nomination and therefore the expiry dates of the directors' terms of office are not all the same, which effectively staggers the renewal of directors.
The allocation of directors' fees is determined by the Board and takes into account the directors' attendance record as well as their possible presence on committees.
Once a year, the Board formally reviews its operations and defines the relevant areas for improvement.
Throughout the year, the Company's management meets with shareholders at specialized events or ad hoc meetings.
The Remuneration Committee, under the supervision of the Board of Directors, ensures compliance with these rules.
The Remuneration Committee, under the supervision of the Board of Directors, ensures compliance with these rules.
Succession is one of the topics discussed at Board meetings, based on the preparatory work of the Nominations and Governance Committee.
No corporate officer combines his or her office with an employment contract within the Company.
There is no contractual provision for remuneration in the event of a corporate officer's departure.
There is no supplementary plan in place for the benefit of a corporate officer.
The Company annually grants stock options and/or free shares to all Group employees and subjects the grants made to the Chief Executive Officer and the members of the Executive Committee to performance conditions.
The directors are aware of the points of vigilance of the Middlenext code and review them regularly.
In accordance with the provisions of Article L. 225-37-4-2° of the French Commercial Code, no agreement has been concluded, either directly or through an intermediary, between a corporate officer or a shareholder holding more than 10% of the voting rights of a company and another company in which the former directly or indirectly holds more than half of the share capital, with the exception of agreements relating to current transactions concluded on normal terms.
On June 10, 2021, the combined general meeting of shareholders approved the appointment of a new director in the person of Ms. Shefali Agarwal, for a term of three years which will expire at the end of the ordinary
general meeting to be held in 2024 to approve the financial statements for the year ending December 31, 2023. Dr. Shefali Agarwal, MD, is Chief Medical Officer at Epizyme, Inc, which develops novel epigenetic therapies for cancer and other serious diseases, where she leads global clinical development and regulatory strategy. Prior to joining Epizyme in 2018, Dr. Agarwal held leadership positions including clinical development and operations, and medical and regulatory affairs. In particular, she led the clinical development and registration of the PARP inhibitor ZEJULA(r) (niraparib) in ovarian cancer for Tesaro in Europe and the United States. In addition, Dr. Agarwal is a member of the board of directors of two U.S. biotechnology companies, ITB Med (private) and Fate Therapeutics (Nasdaq : FATE). She brings to Onxeo her understanding of international clinical operations, in-depth knowledge of the US biotech world and considerable expertise in development.
The meeting of June 10, 2021 also renewed the term of office of Mr. Thomas Hofstaetter as director for three years and ratified the appointment of Invus Public Equities LP as director of the Company in replacement of Mr. Jean-Pierre Kinet, who resigned, for the remaining term of the latter's office, i.e., until the end of the ordinary annual general meeting called to approve the financial statements for the fiscal year ending December 31, 2021.
Mr. Jean-Pierre Bizzari, an independent member of the Board of Directors, resigned from his position at the end of June 2021 for personal reasons.
On July 29, 2021, the Company announced the appointment of Dr. Shefali Agarwal as Chairman of the Board of Directors, in replacement of Ms. Danièle Guyot-Caparros, who remains an independent member of the Board and Chairman of the Audit Committee.
In July 2021, Ms. Christine Garnier resigned as an independent director.
On October 14, 2021, the Company announced the appointment of Dr. Robert L. Coleman and Dr. Jacques Mallet as independent directors:
On November 23, 2021, Mr. Bryan Giraudo joined the company's board of directors as an independent member, in replacement of Thomas Hofstaetter. Bryan Giraudo is both Chief Operating Officer and Chief Financial Officer of Gossamer Bio, a U.S. listed biopharmaceutical company (Nasdaq: GOSS) which specializes in the development and commercialization of innovative therapies in the fields of immunology, inflammation and oncology. Previously, he was a Senior Managing Director at LEERINK Partners, where he was responsible for the life sciences investment banking business for the West Coast of North America and Asia. Prior to joining LEERINK Partners in 2009, Mr. Giraudo was a Managing Director in the Global Healthcare Investment Banking division at Merrill Lynch.
On January 3, 2022, Onxeo announced the appointment of Julien Miara as the new interim CEO in replacement of Ms. Judith Greciet. The latter remains a director at Onxeo as of the date of this Report.
On April 7, 2022, Onxeo announced the appointment of Shefali Agarwal as Chief Executive Officer, replacing Julien Miara.
During the combined general meeting held on April 19, 2022, Julien Miara was appointed director of the Company. He retains his role as permanent representative of Invus, director since June 2020.
The following is a list of all the offices and positions held in all French and foreign companies by each of the Company's directors during the year. This description is extended to the last five years to comply with Annex I of Regulation (EC) No. 809/2004, which governs the drafting of reference documents.
The other offices and/or functions of the directors listed below are based on the declarations of the persons concerned. The Company specifies that it is not responsible for the information provided by the managers or corporate officers.
| Independent Director | Offices and functions |
|---|---|
| Shefali AGARWAL Dr. Shefali Agarwal has been an independent director since June 10, 2021 and was appointed as chairperson of the Company on July 29, 2021. Her term of office will expire at the 2024 General Assembly. On April 7, 2022, Shefali Agarwal was appointed Chief Executive Officer of Onxeo Born on September 27, 1973, Dr. Shefali Agarwal, who is a physician by training, is the Medical and Development Director at Epizyme, Inc., a developer of novel epigenetic therapies for cancer and other serious diseases, where she leads global clinical development and regulatory strategy. Prior to joining Epizyme in 2018, Dr. Agarwal held leadership positions including clinical development and operations, and medical and regulatory affairs. In particular, she led the clinical development and registration of the PARP inhibitor ZEJULA® (niraparib) in ovarian cancer for Tesaro. |
In the Company • Chairwoman of the Board of Directors and chief executive officer Outside the Company • Member of the Board of Directors of ITB Med (not listed) • Member of the Board of Directors of Gritstone Bio (Nasdaq : GTRS) • Member of the Board of Directors of Fate Therapeutics (Nasdaq : FATE) • President of Onxeo US • Director of Topotarget UK Other offices and positions held over the past five years and completed None |
| Danièle GUYOT-CAPARROS Danièle Guyot-Caparros has been an independent director of Onxeo since June 26, 2013 and chaired the Company's Board of Directors between May 2019 and July 2021. Her term of office will expire at the 2022 Shareholders' Meeting. Danièle Guyot-Caparros was born on October 16, 1958. After working in an audit firm on international assignments, she joined Rhône-Poulenc, which became Aventis and then Sanofi, in various positions of increasing scope, with responsibilities in finance at the European level and then in Business Planning and Performance Monitoring at the global level. Senior Life Sciences advisor for Deloitte since 2008, she holds a Master's degree in Finance/Accounting as well as a DECF (chartered accountant diploma). |
In the Company • Director Outside the Company None Other offices and positions held over the past five years and completed • Senior Advisor Life Sciences & Health Care Deloitte France • Member of the Supervisory Board of Diaxonhit • Director of Supersonic Imagine SA (France) |
| Director | Offices and functions |
|---|---|
| Judith GRECIET Judith Greciet joined Onxeo on March 1, 2011 as Deputy CEO in charge of R&D and Operations and served as CEO from June 29, 2011 to January 3, 2022. She has been a director of Onxeo since June 29, 2011. Her term of office will expire at the 2023 Shareholders' Meeting. Born on October 27, 1968, Judith Greciet has spent her career in various international laboratories (notably Eisai, Zeneca, Wyeth) holding positions of increasing managerial and strategic importance in the fields of oncology and immunology, with innovative products. She is a doctor of pharmacy and has a post graduate degree in pharmaceutical management and marketing. |
In the Company • Director Outside the Company None Other offices and positions held over the past five years and completed • Chief executive officer of Onxeo SA • Chairwoman of Onxeo US Inc. • Director of Topotarget UK |
| FINANCIERE DE LA MONTAGNE, represented by Nicolas TREBOUTA Financière de la Montagne has been a director since June 29, 2011. Its term of office will expire at the 2023 Shareholders' Meeting. Born on May 29, 1963, Nicolas Trebouta has been investing directly or through funds in biotech companies since 2004 through his Company Financière de la Montagne. Co-founder of Chevrillon et Associés in 2000, he participated in a number of LBOs with this structure, including Picard surgelés, the printing company CPI, and the insurance company Albingia. He is a physician and has been a shareholder of Onxeo since 2008. |
In the Company • Director Outside the Company • Manager of SARL Financière de la Montagne • Manager of SCI Fleurus Immobilier • Manager of SCI 5 rue de la Liberté • Chairman of SAS Dragon 8 • Managing partner of SC Financière des Associés • Director of GIE IO • Chairman of the Supervisory Board of SCA Chevrillon & Associés • Manager of EARL Ferme de Bissy • Managing partner of SC Valois • Manager of SCI du Trillon • Co-manager of SC Aster • Managing partner of SCI du Chardonnet Other offices and positions held over the past five years and completed None |
| INVUS PUBLIC EQUITIES LP, represented by Julien Miara At its meeting on September 17, 2020, the Board of Directors of Onxeo decided to co-opt Invus Public Equities LP as a Director of the Company. This co-option has been approved at the Company's ordinary general meeting on June 11, 2021. Its term of office will expire at the Shareholders' Meeting in 2022. |
In the Company • Director Outside the Company None Other offices and positions held over the past five years and completed None |
| Director | Offices and functions |
|---|---|
| Julien MIARA Julien MIARA has been a director since April 19, 2022. His term of office will expire at the 2025 General Meeting. Born on June 15, 1983, Julien Miara is a Director at Invus, which he joined in 2010 as an analyst for the investment activity in listed companies (Invus Public Equities LP), particularly covering biotechnologies. In 2018, he was promoted to lead the team in Europe. Previously, he worked in investment banking at BNP Paribas in Paris, Société Générale in New York, and in consulting. Julien Miara obtained his Master's degree in Management from EDHEC Business School in Lille (France) in 2009. |
In the Company • Director Outside the Company • Principal at Invus • Director of Sensorion Other offices and positions held over the past five years and completed • Chief executive officer of Onxeo SA • Chairman of Onxeo US • Director of Topotarget UK |
| Bryan GIRAUDO Bryan Giraudo has served as an independent director since November 23, 2021. His term of office will expire at the 2024 Shareholders' Meeting. Bryan Giraudo was born on May 3, 1975. Bryan Giraudo is both Chief Operating Officer and Chief Financial Officer of Gossamer Bio, a U.S. listed biopharmaceutical company (Nasdaq: GOSS) which specializes in the development and commercialization of innovative therapies in the fields of immunology, inflammation and oncology. Previously, he was a Senior Managing Director at LEERINK Partners, where he was responsible for the life sciences investment banking business for the West Coast of North America and Asia. Prior to joining LEERINK Partners in 2009, Mr. Giraudo was a Managing Director in the Global Healthcare Investment Banking division at Merrill Lynch. |
In the Company • Director Outside the Company • Chief Operating Officer and Chief Financial Officer of Gossamer Bio Inc (USA - Nasdaq : GOSS) • Director of Protagonist Therapeutics (USA) Other offices and positions held over the past five years and completed • Senior Managing Director at Leerink Partners |
| Robert L. COLEMAN At its meeting on October 6, 2021, the Board of Directors of Onxeo decided to co-opt Robert L. Coleman as an independent director of the Company. This cooptation will be submitted to the shareholders for approval at the Company's next ordinary general meeting. Dr. Coleman, born November 3, 1961, is the Scientific Director of the US Oncology Network, one of the largest U.S. networks dedicated to cutting-edge oncology care and research, with more than 400 ongoing clinical trials and over 1,400 physicians. Prior to joining US Oncology Network in 2020, Dr. Coleman was executive director of the MD Anderson Group Cancer Network Research Program. He was also a professor and the Ann Rife Cox Chair in Gynecology at the University of Texas. Dr. Coleman's work has been published in over 500 publications that focus on the role of novel therapies in ovarian cancer, such as the integration of PARP inhibitors into the treatment strategy. |
In the Company • Director Outside the Company • SVP and Chief Scientific Officer, US Oncology Research • Co-Director, GOG-Partners of the GOG Foundation, Inc Other offices and positions held over the past five years and completed • Executive Director of the MD Anderson Group Cancer Network Research Program |
| Director | Offices and functions |
|---|---|
| GAMMAX CORPORATE ADVISORY, represented by Mr. Jacques Mallet |
In the Company • Director |
| At its meeting on October 6, 2021, the Board of Directors of Onxeo decided to co-opt GammaX Corporate Advisory, which is represented by Jacques Mallet, as an independent director of the Company. This cooptation will be submitted to the shareholders for approval at the Company's next ordinary general meeting. |
Outside the Company • Chairman of Gamma-X Corporate Advisory • Director of Technoflex • Director of the Fournier Majoie Foundation |
| Dr. Jacques Mallet, born April 27, 1960, was Senior Vice President - Head of Analytics/Corporate Strategy and a member of the Executive Leadership Team at Sanofi and is currently a member of the Board of Directors of several public and private companies in the health technology sector. Previously, Mr. Mallet was head of investments at Auriga Partners, a leading private equity firm that specializes in life sciences in France, and has held senior positions at international consulting firms such as Monitor Deloitte and Accenture. |
Other offices and positions held over the past five years and completed • Senior Vice President Portfolio Analytics & Corporate Strategy at Sanofi • Director of Isocell |
During fiscal year 2021, 270,916 stock options (SO) were granted to executive directors (Mrs. Judith Greciet), of which 210,916 replaced 421,831 options granted between 2011 and 2017 that were cancelled on that occasion (see summary below).
No stock options were exercised by executive directors during fiscal year 2021.
No performance shares were granted to executive directors in fiscal year 2021.
No performance shares (AGAs) became available in fiscal year 2021.
As part of its policy to remunerate and motivate its managers and employees, Onxeo regularly sets up stock option plans and free share allocation plans.
The independent members of the Board also benefit from successive stock purchase warrant (BSA) plans. As of 2014, these awards have been extended to all directors who are not officers or employees of the Company, including the Chairman of the Board, but excluding the Chief Executive Officer.
For both stock options and warrants, the exercise price is determined as the average of the last twenty stock market prices preceding the grant date.
The terms and conditions of exercise of stock options and warrants that were granted to officers and directors and were outstanding at December 31, 2021 are described in the table below.
Management report including the Corporate governance report 2021 Board of Directors meeting of April 6, 2022
| Stock options | SO Dir.2018 | SO Dir.2020 | SO Dir.2021 | SO Dir.2021-2 |
|---|---|---|---|---|
| Date of meeting | 6/19/2018 | 6/19/2020 | 6/10/2021 | 6/10/2021 |
| Date of the Board of Directors | 7/27/2018 | 9/17/2020 | 7/29/2021 | 7/29/2021 |
| Terms of exercise | 1 SO/1 share - Acquisition over 4 years | Immediate acquisition |
||
| Options granted to corporate directors (Judith Greciet) |
150,723 | 170,000 | 60,000 | 210,916 |
| Starting point of exercise | 6/30/2019 | 9/17/2021 | 7/29/2022 | 7/29/2021 |
| Expiration date | 7/27/2028 | 9/17/2030 | 7/29/2031 | 7/28/2027 |
| Subscription price (1) | 1.187 | 0.684 | 0.62 | 0.62 |
| Shares subscribed as of 12/31/2021 | 0 | 0 | 0 | 0 |
| Canceled or lapsed options | 42,000 | 0 | 0 | 0 |
| Options remaining at 12/31/2021 | 108,723 | 170,000 | 60,000 | 210,916 |
| Share subscription warrants | BSA 2013 | BSA 2014-1 | BSA 2014-2 | BSA 2015-1 | BSA 2016-1 | BSA 2016-3 | BSA 2017 | BSA 2018-1 | BSA 2018-2 | BSA 2020 |
|---|---|---|---|---|---|---|---|---|---|---|
| Date of meeting | 6/26/2013 | 6/30/2014 | 6/30/2014 | 5/20/2015 | 4/06/2016 | 4/06/2016 | 5/24/2017 | 6/19/2018 | 6/19/2018 | 6/19/2020 |
| Date of the Board of Directors | 9/19/2013 | 9/22/2014 | 3/04/2015 | 10/27/2015 | 7/28/2016 | 12/21/2016 | 7/28/2017 | 7/27/2018 | 10/25/2018 | 9/17/2020 |
| Terms of exercise | 1 warrant/ 1 share | 1 warrant/ 1 share (3) |
||||||||
| Shares available for subscription by corporate directors (1) |
15,616 | 26,026 | 5,500 | 15,000 | 30,000 | 17,500 | 80,000 | 85,000 | 42,500 | 225,000 |
| of which Shefali Agarwal | ||||||||||
| of which Danielle Guyot-Caparros | 15,616 | 13,013 | 40,000 | 42,500 | 75,000 | |||||
| of which Financière de la Montagne | 13,013 | 5,500 | 15,000 | 30,000 | 17,500 | 40,000 | 42,500 | 42,500 | 75,000 | |
| of which Invus Public Equities LP | 75,000 | |||||||||
| of which Robert Coleman | ||||||||||
| Of which Bryan Giraudo | ||||||||||
| Of which GammaX Corporate Advisory | ||||||||||
| Starting point for the exercise of the warrants | 3/19/2014 | 3/22/2015 | 9/04/2015 | 4/27/2016 | 1/28/2017 | 6/21/2017 | 4/28/2018 | 6/30/2019 | 6/30/2019 | 3/17/2021 |
| Expiration date | 9/19/2023 | 9/22/2024 | 3/04/2025 | 10/27/2025 | 7/28/2026 | 12/21/2026 | 7/28/2027 | 7/27/2028 | 10/25/2028 | 9/17/2030 |
| Issue price | € 0.40 | € 0.64 | € 0.63 | € 0.36 | €0.26 | €0.24 | € 0.20 | €0.21 (2) | € 0.16 (2) | € 0.16 |
| Subscription price (1) | € 3.85 | € 6.17 | € 6.26 | € 3.61 | €3.16 | €2.43 | € 4.00 | € 1.187 | €1.017 | € 0.684 |
| Shares subscribed as of 12/31/2021 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Total canceled or lapsed warrants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| BSAs remaining at 12/31/2021 (1) | 15,616 | 26,026 | 5,500 | 15,000 | 30,000 | 17,500 | 80,000 | 85,000 | 42,500 | 225,000 |
(1) After adjustment of the number and subscription price of the warrants as a result of the capital increases of July 2011, July 2013 and December 2014, in accordance with Article L. 228-99 of the French Commercial Code (Board of Directors' meetings of July 28, 2011, November 14, 2013 and January 22, 2015)
(2) On May 10, 2019, the Board of Directors decided to raise the subscription price of the warrants retroactively to their market value as determined by an independent expert, in accordance with the recommendations of the AMF.
(3) Acquisition by third party every 6 months
| Share subscription warrants | BSA 2021 | BSA 2021-1 | BSA 2021-3 | BSA 2021-4 |
|---|---|---|---|---|
| Date of meeting | 6/19/2021 | 6/10/2021 | 6/10/2021 | 6/10/2021 |
| Date of the Board of Directors | 4/28/2021 | 6/11/2021 | 7/29/2021 | 10/06/2021 |
| Terms of exercise | 1 warrant/ 1 share |
1 warrant/ 1 share |
1 warrant/ 1 share |
1 warrant/ 1 share |
| Shares that may be subscribed by corporate directors |
150,000 (1) | 100,000 (2) | 75,000 (3) | 75,000 (3) |
| Of which Shefali Agarwal | 150,000 | 100,000 | ||
| Of which Danielle Guyot-Caparros | ||||
| Of which Financière de la Montagne | 75,000 | |||
| Of which Invus Public Equities LP | ||||
| Of which Robert Coleman | 75,000 | |||
| Of which Bryan Giraudo | ||||
| Of which GammaX Corporate Advisory | ||||
| Starting point for the exercise of the warrants | 10/28/2022 | 6/11/2022 | 1/29/2022 | 06,/04/2022 |
| Expiration date | 4/28/2031 | 6/11/2031 | 7/29/2031 | 10/06/2031 |
| Issue price | 0.176 | 0.159 | 0.146 | 0.129 |
| Subscription date | 0.723 | 0.662 | 0.62 | 0.56 |
| Shares subscribed as of 12/31/2020 | 0 | 0 | 0 | 0 |
| Total canceled or lapsed warrants | 0 | 0 | 0 | 0 |
| BSAs remaining at 12/31/2021 | 150,000 | 100,000 | 75,000 | 75,000 |
(1) Full acquisition after 18 months
(2) Full acquisition after 12 months
(3) Acquisition by third party every 6 months
Share subscription or purchase options granted during the year to the ten largest non-executive employees or exercised by them
| Total number of options granted |
Weighted average price |
Plan | |
|---|---|---|---|
| Options granted during the fiscal year to the ten employees (other than corporate directors) with the highest number of options granted (aggregate information) |
438,917 | € 0.62 | SO Employee Plan 2021 and 2021-2 |
| Corporate Directors and Officers |
Employment Contract |
Supplementary pension plan |
Indemnities or benefits due as a result of termination/change of duties |
Compensation for a non competition clause |
||||
|---|---|---|---|---|---|---|---|---|
| Yes | No | Yes | No | Yes | No | Yes | No | |
| Judith Greciet | ||||||||
| Chief Executive Officer since 06/29/2011 Start of mandate : 06/29/2011 End of mandate: Shareholders' Meeting to approve the financial statements for the year ending December 31, 2022 |
X | X | X | X |
At the Board meeting of May 21, 2014, on the proposal of the Compensation and Appointments Committee of May 16, 2014, the Board validated the suspension of Judith Greciet's employment contract as of July 1, 2014 during the period of her corporate mandate as Chief Executive Officer.
In accordance with the provisions of articles L. 225-197-1 and L. 225-185 of the Commercial Code, the Board of Directors, on the recommendation of the Compensation Committee, has set the number of shares (shares allocated or shares resulting from the exercise of options) that the executive directors of Onxeo are obliged to keep in registered form until the termination of their functions This quota has been set at 10% of the acquisition capital gains net of related taxes and contributions obtained by exercising options.
The share capital as of December 31, 2021 was 22,998,733.75 euros, divided into 91,994,935 shares with a par value of 0.25 euros each, all of the same class and fully paid up.
At December 31, 2021, 92.42% of the Company's capital was held by bearer shareholders and 7.58% by registered shareholders.
In accordance with the provisions of Article L. 233-13 of the French Commercial Code, we hereby inform you of the identity of shareholders whose threshold exceeds 5% of the share capital, i.e. who own more than onetwentieth, one-tenth, three-twentieths, one-fifth, one-fourth, one-third, one-half, two-thirds or nineteentwentieths of the share capital or voting rights as of December 31, 2021.
| Shares | Voting rights | ||||
|---|---|---|---|---|---|
| Shareholders | Number of shares |
% of share capital |
Number of voting rights |
% of voting rights |
|
| Financière de la Montagne (Director) | 14,779, 009 | 16.07% | 14,779,009 | 16.14% | |
| Invus Public Equities LP (Director) | 14,031, 037 | 15.25% | 14,031, 037 | 15.32% | |
| Treasury stock | 429,850 | 0.47% | - | - | |
| Other | 62,755, 039 | 68.22% | 62,755, 039 | 68.54% | |
| Total at 12/31/2020 | 91,994,935 | 100.00% | 91,565, 085 | 100.00% |
No shareholders' agreements have been declared to the Company.
| Number | Nominal value (euros) |
Share capital after modification |
|
|---|---|---|---|
| Shares comprising the share capital at year-end | 78,317,810 | 0.25 | 19,579,452.50 |
| Board of Directors' meeting of April 12, 2021: increase in share capital with shareholders' preferential subscription rights, for a nominal amount of 3,419,281.25 euros, through the issue of 13,677,125 ordinary shares on the exercise of warrants with a par value of 0.25 euros each |
13,677,125 | 0.25 | 3,419,281.25 |
| Shares comprising the share capital at year-end | 91,994,935 | 0.25 | 22,998,733.75 |
The fully diluted capital as of December 31, 2021 amounts to 91,994,935 shares. It includes the share capital as of December 31, 2021,2 consisting of 789,944,559 shares plus 2,050,376 shares likely to be issued as a result of the plans for the granting of securities giving access to the Company's capital detailed below, representing a potential dilution of 2.25% on the basis of the capital existing at the closing date of the financial year.
Management report including the Corporate governance report 2021 Board of Directors meeting of April 6, 2022
| Plan Designation | Beneficiaries | Adjusted subscription price (1) per share in euros |
Expiration date |
Adjusted number of warrants/options (1) outstanding at 12/31/20 |
% dilution of | share capital % cumulated | |
|---|---|---|---|---|---|---|---|
| BSA 2013 | Non-employee board members or officers |
3.85 | 9/19/2023 | 88,490 | 0.10% | ||
| BSA 2014 | 6.17 | 9/22/2024 | 85,886 | 0.09% | |||
| BSA 2014-2 | 6.26 | 3/04/2025 | 19,000 | 0.02% | |||
| BSA 2015 | 3.61 | 10/27/2025 | 65,000 | 0.07% | |||
| BSA 2015-2 | 3.33 | 1/23/2026 | 90,000 | 0.10% | |||
| BSA 2016 | 3.16 | 7/28/2026 | 160,000 | 0.17% | |||
| BSA 2016-3 | 2.43 | 12/21/2026 | 52,500 | 0.06% | 2.04% | ||
| BSA-2017 | 4.00 | 7/28/2027 | 300,000 | 0.33% | |||
| BSA 2018 | 1.19 | 7/27/2028 | 274,500 | 0.30% | |||
| BSA 2018-2 | 1.02 | 10/25/2028 | 85,000 | 0.09% | |||
| BSA 2020 | 0.68 | 9/17/2030 | 350,000 | 0.45% | |||
| BSA 2021-2 | 0.662 | 6/11/2031 | 100,000 | 0.11% | |||
| BSA 2021-3 | 0.62 | 7/29/2031 | 125,000 | 0.14% | |||
| BSA 2021-4 | 0.56 | 10/06/2031 | 75,000 | 0.08% | |||
| BSA 2016-2 | Consultants | 2.61 | 10/25/2026 | 30,000 | 0.03% | ||
| BSA 2021 (2) | 0.723 | 4/28/2031 | 150,000 | 0.16% | 0.19% | ||
| SO 2012 | 3.75 | 9/13/2022 | 47,090 | 0.05% | |||
| SO 2014 | 6.17 | 9/22/2024 | 15,616 | 0.02% | |||
| SO 2018 | 1.19 | 7/27/2028 | 98,223 | 0.12% | |||
| SO 2020 | Executives | 0.68 | 9/17/2030 | 42,500 | 0.18% | 0.67% | |
| SO 2021 | 0.62 | 7/29/2031 | 60,000 | 0.07% | |||
| SO 2021-2 | 0.62 | 7/28/2027 | 210,916 | 0.23% | |||
| SO 2012 | 3.75 | 9/13/2022 | 52,321 | 0.06% | |||
| SO 2013 | 3.85 | 9/19/2023 | 31,232 | 0.03% | |||
| SO 2014 | 6.17 | 9/22/2024 | 9,587 | 0.01% | |||
| SO 2017 | 4.00 | 7/28/2027 | 17,625 | 0.02% | |||
| SO 2017-2 | Employees | 1.48 | 3/29/2028 | 25,000 | 0.03% | 2.03% | |
| SO 2018 | 1.19 | 7/27/2028 | 416,805 | 0.45% | |||
| SO 2020 | 0.68 | 9/17/2030 | 822,500 | 0.89% | |||
| SO 2021 | 0.62 | 7/29/2031 | 278,000 | 0.30% | |||
| SO 2021-2 | 0.62 | 7/28/2027 | 218,278 | 0.23% | |||
| TOTAL | 4,534, 069 | 4.93% |
(1) After adjustment of the number and subscription price of warrants, options and free shares as a result of the capital increases of July 2011, July 2013 and December 2014, in accordance with Article L. 228-99 of the French Commercial Code
(2) Grant to Ms. Shefali Agarwal under a consultancy agreement entered into prior to her appointment as a director of the Company (June 10, 2021)
Pursuant to the provisions of Article L. 225-185 of the French Commercial Code, the Board of Directors has decided that the Chief Executive Officer must hold in registered form, until he or she ceases to hold office, 10% of the shares resulting from the exercise of options granted by the Board, up to a limit of a number of options such that their cumulative exercise price does not exceed one year's total gross compensation
In accordance with the provisions of Article L. 225-197-1 II paragraph 4, the Board of Directors has decided that the Chief Executive Officer must hold in registered form, until the end of his or her term of office, 10% of the shares allocated, up to a number of shares such that their cumulative value does not exceed one year's total gross compensation.
| In euros | 2017 | 2018 | 2019 | 2020 | 2021 |
|---|---|---|---|---|---|
| Capital at year-end | |||||
| Share capital | 12,673,913 | 13,344,094 | 15,329, 462.75 | 19,579,452.50 | 22,998,733.75 |
| Number of existing common shares | 50,695, 653 | 53,376,375 | 61,317,851 | 78,317,810 | 91,994,935 |
| Number of existing preferred shares | |||||
| Maximum number of future shares to be created : | |||||
| By conversion of bonds | |||||
| By exercising the subscription right | |||||
| Operations and results for the year | |||||
| Turnover before tax | 894,784 | 548,504 | 1,150, 646 | 488,518 | 45,523 |
| Income before tax, employee profit-sharing, depreciation and provisions | -30,432, 231 | -9,632,677 | -23,097, 256 | -8,246, 501 | -10,252,400 |
| Income taxes | -3,686, 612 | -2,436,446 | -1,381,822 | -794,638 | -1,744,594 |
| Employee profit-sharing due for the year | |||||
| Income after tax, employee profit-sharing, depreciation and provisions | -66,424, 572 | -12,955,412 | -28,967, 798 | -3,566, 539 | -5,351,535 |
| Distributed income | |||||
| Earnings per share | |||||
| Income after tax, employee profit-sharing, but before depreciation and provisions | -0.53 | -0.13 | -0.35 | -0.09 | -0.08 |
| Income after tax, employee profit-sharing, depreciation and provisions | -1.31 | -0.24 | -0.47 | -0.05 | -0.03 |
| Dividend allocated to each share | |||||
| Staff | |||||
| Average number of employees during the year | 49 | 39 | 30 | 25 | 25 |
| Total payroll for the year | 5,181, 976 | 3,202,473 | 3,029, 115 | 2,773, 547 | 2,607, 315 |
| Amounts paid for employee benefits | 2,395, 768 | 1,449,962 | 1,490, 970 | 1,258, 312 | 1,211,015 |
In accordance with the provisions of Article L. 225-37-4 of the French Commercial Code, we hereby report to you on the current delegations of authority granted by the Shareholders' Meeting to the Board of Directors to increase the share capital, and on the use made of these delegations during the year ended December 31, 2021.
| Duration of validity / expiry date |
Ceiling (nominal value) |
Use made of the delegation | ||||
|---|---|---|---|---|---|---|
| Delegations granted by the Shareholders' Meeting of June 19, 2020 | ||||||
| Delegation of authority granted to the Board of Directors to increase the share capital, immediately or in the future, by issuing ordinary shares or any securities giving access to the share capital, with preferential subscription rights (17th resolution) |
26 months / August 19, 2022 This delegation was replaced by the delegation granted by the General Meeting of June 10, 2021 under its 9th resolution |
€16,865,558 (67.462.232 shares) |
On March 9, 2021, the Chief Executive Officer, acting on the authority of the Board of Directors, decided to carry out a capital increase for a basic amount of 9,267,607 euros by issuing 13,052,968 shares at a unit price of 0.71 euros. Following the Board's use of the option provided for in the 20th resolution, the capital increase amounted to a total nominal amount of 3,419,281.25 euros, through the issue of a total of 13,677,125 euros, i.e. a total capital increase, including the issue premium, of 9,710,758.75 euros. |
|||
| Delegation of authority granted to the Board of Directors to increase the capital by issuing ordinary shares or any securities giving access to the capital, with waiver of shareholders' preferential subscription rights and public offering (18th resolution) |
26 months / August 19, 2022 This delegation was replaced by the delegation granted by the General Meeting of June 10, 2021 under its 10th resolution |
€16,865,558 (67.462.232 shares) |
The Board did not make use of this delegation. |
|||
| Delegation of authority granted to the Board of Directors to issue shares or any securities giving immediate or future access to the capital, without shareholders' pre-emptive subscription rights, by means of the offer referred to in Article L 411-2 of the French Monetary and Financial Code (19th resolution) |
26 months / August 19, 2022 This delegation was replaced by the delegation granted by the General Meeting of June 10, 2021 under its 11th resolution |
€3,373,112 (13.492.450 shares) |
The Board did not make use of this delegation. |
|||
| Delegation of authority granted to the Board of Directors to increase the amount of issues with or without preferential subscription rights that would be decided pursuant to the 17th to 19th resolutions above (20th resolution) |
26 months / August 19, 2022 This delegation was replaced by the delegation granted by the General Meeting of June 10, 2021 under its 12th resolution |
15% of the initial issue |
This delegation was used in the context of the capital increase with preferential subscription rights for shareholders recorded on April 12, 2021. |
| Duration of validity / expiry date |
Ceiling (nominal value) |
Use made of the delegation | |
|---|---|---|---|
| Authorization granted to the Board of Directors, in the event of the issue of shares or any other securities giving access to the capital with cancellation of the shareholders' preferential subscription rights, to set the issue price within the limit of 10% of the share capital and within the limits provided for by the General Meeting by virtue of the delegations decided under the terms of the 18th and 19th resolutions above (21st resolution) |
26 months / August 19, 2022 |
Up to 10% of the share capital |
The Board did not make use of this authority. |
| Delegation of authority granted to the Board of Directors to increase the capital by issuing ordinary shares or any securities giving access to the capital, with waiver of shareholders' preferential subscription rights in favor of a first category of persons (22nd resolution) |
18 months / December 19, 2021 |
€6,746,223 (26.984.892 shares) |
The Board did not make use of this delegation. |
| Delegation of authority granted to the Board of Directors to increase the capital by issuing ordinary shares or any securities giving access to the capital, with waiver of shareholders' preferential subscription rights in favor of a second category of persons (24th resolution) |
18 months / December 19, 2021 |
€6,746,223 (26.984.892 shares) |
The Board did not make use of this delegation. |
| Delegation of authority to the Board of Directors to increase the capital by issuing ordinary shares or any other securities without shareholders' pre-emptive subscription rights for the benefit of a category of persons within the framework of an equity or bond financing agreement (26th resolution) |
18 months / December 19, 2021 |
€3,373,112 (13.492.450 shares) |
The Board did not make use of this delegation. |
| Delegation of authority granted to the Board of Directors to increase the share capital, within the limits of 10% of the share capital, in order to remunerate contributions in kind of equity securities or securities giving access to the share capital of third-party companies outside a public exchange offer (27th resolution) |
26 months / August 19, 2022 |
10% of the share capital |
The Board did not make use of this delegation. |
| Authorization for the Board of Directors to grant stock options (30th resolution) |
38 months / August 19, 2022 This delegation was replaced by the delegation granted by the Shareholders' Meeting of June 10, 2021 under its 18th resolution |
1,200,000 options representing a maximum nominal amount of 300,000 euros |
See special report of the Board of Directors - grant of 1,200,000 stock options on September 17, 2020 |
| Delegation of authority to the Board of Directors to issue a maximum of 500,000 warrants to members of the Board of Directors in office on the date of |
18 months / December 19, 2021 This delegation was replaced by the |
500,000 warrants representing a maximum |
See additional reports of the Board of Directors and the Statutory Auditor. The Board of Directors made use of this delegation on April |
| Duration of validity / expiry date |
Ceiling (nominal value) |
Use made of the delegation | |
|---|---|---|---|
| allocation of the warrants, who are not employees or executives of the Company or one of its subsidiaries, and persons linked by a service or consultancy contract to the Company or one of its subsidiaries (31st resolution) |
delegation granted by the Shareholders' Meeting of June 10, 2021 under its 18th resolution |
nominal amount of 125,000 euros |
28, 2021 and decided to issue 150,000 warrants giving the right to subscribe for one share of the Company with a nominal value of 0.25 euro at a price of 0.723 euro (including issue premium) to Mrs. Shefali Agarwal, who was then a consultant of the Company. |
| Delegations granted by the Shareholders' Meeting of June 10, 2021 | |||
| Delegation of authority granted to the Board of Directors to increase the share capital immediately or in the future by issuing ordinary shares or any securities giving access to the share capital, with preferential subscription rights (9th resolution) |
26 months / August 10, 2023 |
€22,998,733 (91.994.932 shares) |
The Board did not make use of this delegation. |
| Delegation of authority granted to the Board of Directors to increase the capital by issuing ordinary shares or any securities giving access to the capital, without preferential subscription rights for shareholders and with a public offering (10th resolution) |
26 months / August 10, 2023 |
€22,998,733 (91.994.932 shares) |
The Board did not make use of this delegation. |
| Delegation of authority granted to the Board of Directors to issue shares or any securities giving immediate or future access to the capital, without shareholders' pre-emptive subscription rights, as part of an offer referred to in paragraph 1 of Article L 411-2 of the French Monetary and Financial Code (11th resolution) |
26 months / August 10, 2023 |
€ 4,599,746 (18.398.984 shares) |
The Board did not make use of this delegation. |
| Delegation of authority granted to the Board of Directors to increase the amount of issues with or without preferential subscription rights that may be decided pursuant to the 9th to 11th resolutions above (12th resolution) |
26 months / August 10, 2023 |
15% of the initial issue |
The Board did not make use of this delegation. |
| Delegation of authority granted to the Board of Directors to increase the capital by issuing ordinary shares or any securities giving access to the capital, with waiver of shareholders' preferential subscription rights, for the benefit of a first category of persons (investors active in the healthcare or biotechnology sectors) (13th resolution) |
18 months /December 10, 2022 |
€ 9,199,493 (36,797 972 shares) |
On April 6, 2022, the Board decided on a capital increase for a total nominal amount of €4,878,048.75, by issuing a total number of €19,512,195 at a unit price of €0.41, i.e. an increase of capital for a total amount, issue premium included, of 8,000,000 euros. The Board also decided on the same date to issue 4,000,000 convertible bonds with a nominal value of one euro each, i.e. total gross proceeds of 4,000,000 euros. |
| Delegation of authority to the Board of Directors to increase capital by issuing ordinary shares or any securities giving |
18 months /December 10, 2022 |
€ 9,199,493 (36,797 972 shares) |
The Board did not make use of this delegation. |
| Duration of validity / expiry date |
Ceiling (nominal value) |
Use made of the delegation | |
|---|---|---|---|
| access to capital, without shareholders' pre-emptive subscription rights, for the benefit of a second category of persons (industrial companies active in the health or biotechnology sectors) (14th resolution) |
|||
| Delegation of authority to the Board of Directors to increase the capital by issuing ordinary shares or any other securities without shareholders' pre-emptive subscription rights for the benefit of a category of persons within the framework of an equity or bond financing agreement (15th resolution) |
18 months /December 10, 2022 |
€ 4,599,746 (18.398.984 shares) |
The Board did not make use of this delegation. |
| Authorization for the Board of Directors to grant stock options (18th resolution) |
38 months / August 10, 2024 |
1.500.000 options representing a maximum nominal amount of 375,000 euros |
See special report of the Board of Directors - grant of 770,194 stock options on July 29, 2021 and of 250,000 stock options on February 2, 2022. |
| Delegation of authority to the Board of Directors to issue a maximum number of 700,000 warrants to members of the Board of Directors in office on the date of allocation of the warrants, who are not employees or managers of the Company or of one of its subsidiaries, and persons linked by a service or consultancy contract to the Company or one of its subsidiaries (19th resolution) |
18 months /December 10, 2022 |
700,000 warrants representing a maximum nominal amount of 175,000 euros |
See additional reports of the Board of Directors and the Statutory Auditor. The Board of Directors made use of this delegation: - on July 29, 2021, the Board of Directors decided to issue 300,000 warrants giving the right to subscribe for one share of the Company with a par value of 0.25 euro at a price of 0.62 euro (including issue premium) for the benefit of non-executive directors, and - on October 6, 2021, the Board of Directors decided to issue 150,000 warrants giving the right to subscribe for one share of the Company with a par value of 0.25 euro at a price of 0.56 euro (including issue premium) to non executive directors - on February 2, 2022, the Board of Directors decided to issue 225,000 BSA giving the right to subscribe to one Company share with a par value of 0.25 euro at a price of 0.42 euro (premium issue included) for the benefit of non-executive directors and key consultants. |
PREPARED ACCORDING TO FRENCH STANDARDS
| BALANCE SHEET | 64 |
|---|---|
| BALANCE SHEET ASSETS 64 | |
| BALANCE SHEET LIABILITIES 65 | |
| INCOME STATEMENT | 66 |
| INCOME STATEMENT (PART 1) 66 | |
| INCOME STATEMENT (PART 2) 67 | |
| ACCOUNTING METHODS AND RULES | 68 |
| 1 ACCOUNTING PRINCIPLES AND METHODS 68 | |
| 1.1 Intangible fixed assets 68 | |
| 1.2 Tangible assets 69 | |
| 1.3 Financial fixed assets 69 | |
| 1.4 Stocks and work in progress 69 | |
| 1.5 Receivables and payables 69 | |
| 1.6 Marketable securities 69 | |
| 1.7 Liquid assets 69 | |
| 1.8 Provisions for liabilities and charges 69 | |
| 1.9 Licensing Agreements 70 | |
| 1.10 Grants 70 | |
| 2 SIGNIFICANT EVENTS THAT OCCURRED DURING THE FINANCIAL YEAR 70 | |
| 2.1. R&D programs 70 | |
| 2.2 Funding 71 | |
| 2.3. Impacts of the health crisis 72 | |
| 2.4 Events after December 31, 2021 72 | |
| 3 NOTES TO THE BALANCE SHEET 72 | |
| 3.1 Intangible fixed assets 72 | |
| 3.2 Tangible assets 74 | |
| 3.3 Financial fixed assets 74 | |
| 3.4 Trade receivables 74 | |
| 3.5 Other receivables 74 | |
| 3.6 Cash position 74 | |
| 3.7 Prepaid expenses 74 | |
| 3.8 Shareholders' equity 75 | |
| 3.9 Other equity 75 | |
| 3.10. Provisions for liabilities and charges 75 | |
| 3.11. Other debenture loans 75 | |
| 3.12. Trade payables 75 | |
| 3.13. Tax and social security liabilities 75 | |
| 3.14. Other liabilities 76 | |
| 4 NOTES ON THE RESULT 76 | |
| 4.1 Revenues 76 | |
| 4.2 License fees 76 | |
| 4.3 Other operating income 76 | |
| 4.4 External expenses 76 | |
| 4.5 Personnel expenses 76 | |
| 4.6 Financial income/loss 76 | |
| 4.7 Extraordinary result 76 | |
| 4.8 Income taxes 77 | |
| 5 OFF-BALANCE SHEET COMMITMENTS 77 | |
|---|---|
| 5.1 Pension obligations 77 | |
| 5.2 Leasing commitments 77 | |
| 6 COMPENSATION OF CORPORATE OFFICERS 77 | |
| 7 RELATED PARTIES 77 | |
| 8 INTRA-GROUP TRANSACTIONS 78 | |
| APPENDIX TABLES | 79 |
| FIXED ASSETS 79 | |
| AMORTIZATION TABLE 80 | |
| TABLE OF PROVISIONS 81 | |
| RECEIVABLES 82 | |
| LIABILITIES 82 | |
| ACCRUED INCOME 83 | |
| ACCRUED EXPENSES 83 | |
| TABLE OF CHANGES IN SHAREHOLDERS' EQUITY 84 | |
| LEASING 84 | |
| AVERAGE HEADCOUNT 85 | |
| RELATED COMPANIES AND SHAREHOLDINGS 85 | |
| TABLE OF SUBSIDIARIES AND AFFILIATES (IN THOUSANDS OF EUROS) 86 |
| In thousands of euros | Gross | Amortization / Impairment |
Net 2021 | Net 2020 |
|---|---|---|---|---|
| UNCALLED SUBSCRIBED CAPITAL | ||||
| INTANGIBLE ASSETS | ||||
| Set-up expenses | ||||
| Development costs | 65 089 | 61 830 | 3 259 | 3 259 |
| Concessions, patents and similar rights | 181 | 181 | ||
| Commercial Fund | 4 450 | 4 450 | 4 450 | |
| Other intangible assets | 244 | 244 | 4 | |
| Advances and down payments on intangible assets |
||||
| Total intangible assets | 69 964 | 62 255 | 7 709 | 7 713 |
| TANGIBLE ASSETS | ||||
| Land | ||||
| Constructions | ||||
| Technical installations, industrial equipment and tools |
1 346 | 1 291 | 55 | 49 |
| Other tangible assets | 1 935 | 1 809 | 126 | 34 |
| Assets under construction | ||||
| Advances and down payments | ||||
| Total tangible assets | 3 281 | 3 100 | 180 | 83 |
| FINANCIAL FIXED ASSETS | ||||
| Investments accounted for using the equity method |
||||
| Other investments | 48 578 | 42 746 | 5 831 | 5 056 |
| Receivables related to investments | ||||
| Other long-term securities | 181 | 181 | 182 | |
| Other financial fixed assets | 155 | 155 | 226 | |
| Total financial fixed assets | 48 914 | 42 746 | 6 167 | 5 464 |
| FIXED ASSET | 122 159 | 108 102 | 14 057 | 13 260 |
| STOCKS | ||||
| Raw materials, supplies | ||||
| Goods in process of production | ||||
| Services in process of production | ||||
| Intermediate and finished products | ||||
| Goods | ||||
| Total Inventories | ||||
| RECEIVABLES | ||||
| Advances and deposits paid on orders | ||||
| Trade receivables and related accounts | 597 | 597 | 548 | |
| Other receivables | 30 121 | 19 819 | 10 303 | 5 400 |
| Capital subscribed and called up, not paid | ||||
| Total receivables | 30 719 | 19 819 | 10 900 | 5 948 |
| LIQUID ASSETS | ||||
| Securities: Liquid assets |
17 371 | 17 371 | 14 433 | |
| Total liquid assets | 17 371 | 17 371 | 14 433 | |
| CURRENT ASSET | 48 090 | 19 819 | 28 271 | 20 381 |
| Prepaid expenses | 1 440 | 1 440 | 396 | |
| Deferred loan issue expenses | ||||
| Bond redemption premiums | ||||
| Currency translation differences assets | 226 | 226 | 37 | |
| GENERAL TOTAL | 171 914 | 127 921 | 43 994 | 34 074 |
| In thousands of euros | Net 2021 | Net 2020 | |
|---|---|---|---|
| NET POSITION | |||
| Share or individual capital Of which paid in: |
22 999 | 22 999 | 19 579 |
| Share premiums, merger premiums, contribution premiums, | 5 278 | ||
| Revaluation differences | |||
| Legal reserve | |||
| Statutory or contractual reserves | |||
| Regulated reserves | |||
| Other reserves | |||
| Carry forward | (12 913) | (9 347) | |
| RESULT FOR THE YEAR (profit or loss) | (4 332) | (3 567) | |
| Total net equity | 17 037 | 11 944 | |
| Investment subsidies | |||
| Regulated provisions | |||
| EQUITY | 17 037 | 11 944 | |
| Proceeds from issues of equity securities | |||
| Conditional advances | 164 | 327 | |
| OTHER EQUITY | 164 | 327 | |
| Provisions for risks | 226 | 37 | |
| Provisions for expenses | 200 | 327 | |
| Provision for risks and expenses | 426 | 363 | |
| FINANCIAL DEBTS | |||
| Convertible bonds | |||
| Other debenture loans | 2 771 | 3 472 | |
| Borrowings and debts with credit institutions | 5 006 | 2 | |
| Miscellaneous borrowings and financial liabilities | 300 | 220 | |
| Total financial liabilities | 8 077 | 3 694 | |
| OPERATING LIABILITIES | |||
| Advances and deposits received on current orders | |||
| Trade payables and related accounts | 3 071 | 3 240 | |
| Tax and social security liabilities | 647 | 1 262 | |
| Total operating liabilities | 3 719 | 4 501 | |
| MISCELLANEOUS LIABILITIES | |||
| Debts on fixed assets and related accounts | |||
| Other debts | 10 599 | 10 069 | |
| Total miscellaneous liabilities | 10 599 | 10 069 | |
| ACCRUALS | |||
| Deferred revenue | 23 | ||
| DEBTS | 22 394 | 18 287 | |
| Currency translation differences liabilities | 3 973 | 3 152 | |
| GENERAL TOTAL | 43 994 | 34 074 |
| In thousands of euros | France | Export | Net 2021 | Net 2020 |
|---|---|---|---|---|
| Sale of goods | 472 | |||
| Sold production of goods | ||||
| Sold production of services | 7 | 38 | 46 | 17 |
| NET TURNOVER | 7 | 38 | 46 | 489 |
| Stored production | ||||
| Capitalized production | ||||
| Operating grants | 23 | 81 | ||
| Reversals of depreciation, amortization and provisions, expense transfers |
3 613 | 235 | ||
| License fees and other products | 1 860 | 9 080 | ||
| TOTAL REVENUE | 5 542 | 9 884 | ||
| EXTERNAL EXPENSES | ||||
| Purchase of goods (including customs duties) | ||||
| Inventory change (goods) | 64 | |||
| Purchase of raw materials and other supplies (including customs duties) |
294 | 222 | ||
| Change in inventories (raw materials and supplies) | ||||
| Other purchases and external expenses | 6 225 | 5 460 | ||
| Total external expenses | 6 519 | 5 746 | ||
| Tax, duties and other levies | 161 | 173 | ||
| PERSONNEL EXPENSES | ||||
| Wages and salaries | 2 607 | 2 774 | ||
| Social security charges | 1 211 | 1 258 | ||
| Total personnel expenses | 3 818 | 4 032 | ||
| Operating allocations | 43 | 2 589 | ||
| Depreciation of fixed assets Allocations to provisions on fixed assets |
||||
| Allocations to provisions on current assets | 118 | 77 | ||
| Allocations to provisions for risks and expenses | ||||
| Total operating allowances | 162 | 2 666 | ||
| OTHER OPERATING EXPENSES | 428 | 949 | ||
| TOTAL OPERATING EXPENSES | 11 088 | 13 566 | ||
| OPERATING INCOME | (5 547) | (3 682) |
| In thousands of euros | Net 2021 | Net 2020 |
|---|---|---|
| OPERATING INCOME | (5 547) | (3 682) |
| JOINT OPERATIONS | ||
| Profit allocated or loss transferred | ||
| Loss incurred or profit transferred | ||
| FINANCIAL PROCEEDS | ||
| Financial income from investments | 4 | 28 |
| Income from other securities and receivables from fixed assets | 8 | 1 |
| Other interest and similar income | 3 | |
| Reversals of provisions and expense transfers | 812 | 568 |
| Positive exchange rate differences | 12 | 158 |
| Net proceeds from sales of marketable securities | ||
| TOTAL FINANCIAL INCOME | 836 | 758 |
| FINANCE CHARGES | ||
| Depreciation, amortization and provisions | 226 | 37 |
| Interest and similar charges | 1 117 | 1 195 |
| Negative exchange rate differences | 2 | 112 |
| Net expenses on disposals of marketable securities | ||
| TOTAL FINANCIE CHARGES | 1 344 | 1 344 |
| FINANCIAL RESULT | (508) | (587) |
| CURRENT RESULT | (6 054) | (4 269) |
| EXTRAORDINARY PROCEEDS | ||
| Extraordinary income on management operations | 84 | 55 |
| Extraordinary income on capital transactions | 22 | 289 |
| Reversals of provisions and expense transfers | 127 | 6 000 |
| TOTAL EXTRAORDINARY INCOME | 232 | 6 343 |
| SPECIAL CHARGES | ||
| Exceptional expenses on management operations | 158 | 6 082 |
| Exceptional expenses on capital transactions | 97 | 154 |
| Exceptional depreciation, amortization and provisions | 200 | |
| TOTAL EXCEPTIONAL EXPENSES | 255 | 6 436 |
| EXTRAORDINARY RESULT | (23) | (92) |
| Employee profit-sharing | ||
| Income taxes | (1 745) | (795) |
| TOTAL REVENUE | 6 610 | 16 985 |
| TOTAL EXPENSES | 10 943 | 20 552 |
Onxeo (the "Company") is a clinical-stage biotechnology company developing novel cancer drugs by targeting tumor DNA functions through unique mechanisms of action in the highly sought-after area of DNA damage response (DDR). The Company focuses on the development of novel first-in-class or disruptive compounds (inhouse, acquired or in-licensed) from translational research to human clinical proof-of-concept, a value-creating and attractive inflection point for potential partners.
Onxeo's accounts as of December 31,2021 were prepared under the responsibility of the Chief Executive Officer and were approved by the Board of Directors on April 1, 2022.
The annual financial statements for the year ended December 31, 2021 have been prepared and presented in accordance with the provisions of the French Commercial Code, the French General Chart of Accounts and ANC regulation 2016--07 of November 4, 2016, in compliance with the principle of prudence and the independence of financial years.
The financial statements have been prepared on a going concern basis. This principle was adopted by the Board of Directors on the basis of a net cash position of 17.4 million euros at December 31 2021 and financing commitments from its two main shareholders, Invus and Financière de la Montagne, for a minimum of 12 million euros. The Company can thus finance its activities at least into Q2 2023 based on its financing plan.
The items recorded in the accounts are valued using the historical cost method. The valuation methods used for this year have not been changed from the previous year.
Intangible assets are recorded at their acquisition cost or contribution value, minus accumulated amortization and any impairment losses.
Research and development costs incurred by the company are directly expensed. They may be immobilized when the following conditions are simultaneously met:
The projects involved are clearly individualized,
Each project must have, at the date of establishment of the accounts, a serious chance of technical success and commercial profitability,
Their cost can be clearly established.
These criteria are considered not to be met until a marketing authorization has been obtained.
Acquired research and development projects are recognized as intangible assets at their contributed value even in the absence of a marketing authorization.
When their useful life is defined, the cost of intangible assets, minus any residual value, is amortized over the useful life expected by the Company. This period is determined on a case-by-case basis according to the nature and characteristics of the items included under this heading. In particular, concessions and patents are amortized over 10 years on a straight-line basis and software is amortized over 12 months on a straight-line basis and R&D assets with a finite life (in the marketing phase) are amortized over the useful life expected by the Company.
When their useful life is indefinite, intangible assets are not amortized but are subject to annual impairment tests. The goodwill is tested at least once a year, at the end of the financial year. Assets relating to acquired molecules not yet marketed (and therefore not yet depreciated) are also tested on an annual basis, at the end of the financial year, and as soon as an impairment indicator is identified. For example, slower than expected commercialization may be an indication of impairment.
The gross value of the tangible fixed assets corresponds to the value at which the assets were acquired, accounting for the costs necessary to bring the assets to a usable condition, but excluding the costs incurred for their acquisition.
Amortization for impairment is determined on a straight-line basis. The depreciation periods and methods most commonly used are as follows:
| Machinery and equipment | 5 years |
|---|---|
| Specialized facilities | 5 years |
| General installations | 10 years |
| Office and computer equipment | 4 years |
| Furniture | 5 years |
Equity interests and other long-term investments are valued at the price for which they were acquired, excluding the costs incurred in their acquisition.
A provision for impairment is recorded if, at the end of the financial year, the value in use is lower than the book value. The value in use of the securities is established on the basis of the net assets at the closing date. The outlook for profitability requires the exercise of Management's judgment in order to confirm the assessment made of the net book value of the equity securities.
The amounts involved in a liquidity contract managed by an Investment Services Provider (ISP) are recorded in the accounts:
under "Other long-term investments" for treasury stock (the portion invested in company shares), under "Other financial assets" for the part retained in cash.
Inventories and work-in-progress are valued at cost using the weighted average cost method.
A provision for impairment is recorded if the present value is lower than the carrying amount.
Receivables and payables are valued at their nominal value. A provision for impairment is recorded if, at the end of the financial year, the present value of the receivables is less than the book value.
Payables and receivables in foreign currencies are recorded at the exchange rate on the day of the transaction and are revalued at the closing rate. The exchange differences thus recorded are recorded as translation differences. A provision for expenses is recorded in the event of an unrealized foreign exchange loss.
Receivables are reviewed on a case-by-case basis and a provision for impairment is established according to the risk incurred.
Marketable securities are valued at acquisition cost, excluding expenses incurred for their acquisition.
In the event of a sale of a group of securities of the same type conferring the same rights, the entry value of the securities sold is estimated using the P.E.P.S. method.
Cash in hand or at the bank is valued at nominal value.
Provisions correspond to commitments resulting from litigation and miscellaneous risks, the timing and amount of which are uncertain, that the company may face during its business. A provision is recognized when the company has a legal or constructive obligation to a third party as a result of a past event that is probable or certain to result in an outflow of resources to the third party, without at least equivalent consideration expected from the third party, and the future cash outflow can be reliably estimated.
Agreements whereby the Company licenses to a third party the right to commercialize one or more products in its portfolio generally include a payment upon signature as well as subsequent payments and royalties on sales.
Payments due in respect of the signature of a license agreement, representing the co-contractor's share of past R&D investments and research expenses remaining payable by Onxeo, are initially recognized as prepaid income and spread over the term of the contract or a shorter period, depending on the company's involvement or the specific features of the contract. This duration generally corresponds to the estimated time required to obtain marketing authorization for the product concerned and this estimate is reviewed annually by the Management. In general, subsequent payments are conditional and depend on the achievement of certain objectives: registration of products, placing products on the market, obtaining a price and/or reaching sales thresholds (sales performance). They are recognized immediately in other income in the year in which they are received by the Company.
In addition, the company benefits from royalties corresponding to a percentage of the net sales effectively realized by the partners over the period, in application of a contractual rate. Royalties are generally calculated on the basis of monthly or quarterly reporting from the partners. At closing, in the event that reporting for the last period has not been received, royalties are valued on the basis of actual quantities sold using a historical net selling price.
In the case of a disposal of assets, the initial payments will be fully recognized on the date the contract is signed.
Operating grants are charged to income at the rate of the expenses incurred.
Repayable advances are recognized in "Other equity". If the project is successful, these advances will be reimbursed taking into account the operational forecast of the project's proceeds. In the event of a duly justified failure with the lending institution, the advances received will generally remain vested and will be recognized in the income statement.
The Company actively pursued preclinical and clinical development of systemic AsiDNA™ in combination with other therapies in various types of solid tumors in 2021 and achieved several major milestones:
On the clinical front, in February it entered into a research agreement with the Institut Curie to conduct a Phase 1b/2 study to evaluate the effect of AsiDNA™ in combination with radiotherapy in children with recurrent high-grade glioma (HGG), an orphan brain cancer with a poor prognosis. This study was approved in late 2021 and the first patients will be enrolled in early 2022. In parallel, Onxeo completed the DRIIV-1b trial of AsiDNA™ in combination with reference chemotherapies, carboplatin and then carboplatin and paclitaxel, in patients with advanced solid tumors that were progressing at inclusion. The very favorable safety profile of AsiDNA™ was confirmed and significantly longer control times were observed than with previous treatment lines, including those involving platinum salt chemotherapies. These results were published in March 2021. The Company also continued the Revocan Phase 1b/2 clinical trial to evaluate the combination of AsiDNA™ with PARP inhibitors in the 2nd line maintenance treatment of relapsed ovarian cancer. Gustave Roussy is the sponsor of this study. The pace of recruitment has been slower than expected, partly due to the health crisis, and the initial results are now expected in the second half of 2022.
On the preclinical front, Onxeo presented results from preclinical studies at the American Association for Cancer Research (AACR) Annual Meeting in April 2021 showing the ability of AsiDNA™, to prevent drugtolerant persister cell (DTP)-induced resistance to KRAS inhibitors (KRASi). The previous year, Onxeo had already demonstrated for the first time at the AACR that these DTPs were involved in tumor resistance to PARP inhibitors. The role of persister cells in resistance to other targeted therapies such as tyrosine kinase inhibitors has long been established. The effect of AsiDNA™ on these cells may allow it to become a gold standard combination therapy to counter resistance to multiple targeted therapies when induced by persister cells and preclinical evaluation of novel combinations of AsiDNA™ in this setting is ongoing. The Company also presented its DTP results at the EACR-AstraZeneca virtual conference held in December 2021. OX400
After AsiDNA™, Onxeo is developing the OX400 family based on Onxeo's platON™ chemistry platform, which enables the design of new molecules based on oligonucleotides (a double-stranded DNA fragment).
This family of molecules is positioned both in the field of inhibition of the DNA damage response (DDR) and in immuno-oncology.
During 2021, the Company continued to optimize OX401 in order to improve its action on the PARP protein, which is involved in the tumor DNA repair cascade, and its activation of the antitumor immune response via the cGAS-STING pathway. The Company plans to have the optimized compound selected and in preclinical development in 2022.
On January 28, 2021, the Company announced that it had obtained non-dilutive funding of 5 million euros in the form of State-Backed Loans. This funding is part of the measures put in place by the French government to support French companies in the context of the COVID-19 pandemic and allows the Company to strengthen its cash position.
The loans are 90% guaranteed by the French government, have interest rates ranging from 0.25% to 1.75%, including the government guarantee, and have a 12-month maturity. After this initial period, the Company has chosen to repay these loans over a period of 5 years starting in February 2022, the first year being a grace period during which only interest will be paid.
On March 10, 2021, the Company announced the launch of a capital increase with preferential subscription rights for shareholders in France and Denmark based on the seventeenth and twentieth resolutions adopted by the extraordinary shareholders' meeting of June 19, 2020. This operation was the subject of a prospectus approved by the AMF under no. 21-063.
The proceeds of this issue of New Shares were intended to primarily finance the expansion and acceleration of development clinical use of AsiDNA ™, especially in combination with other anti-cancer agents. The Company also intends to continue the optimization and preclinical development of new candidates from the platON ™ platform, optimize pharmaceutical development and compound manufacturing operations, and more generally, finance the activity of the Company.
The main terms of the operation are summarized below:
- Subscription parity: 1 new share for 6 existing shares
subscription commitments of the two reference shareholders, Financière de la Montagne and Invus Public Equities LP)
On April 12, 2021, the Company announced the success of this capital increase, with a subscription rate of approximately 104.8%. The gross amount of the capital increase, including share premium, amounted to 9,7 million euros. This transaction extended the Company's financial horizon to the fourth quarter of 2022.
The Company's capital following the capital increase amounts to 22,998,733.75 euros, divided into 91,994,935 shares with a par value of 0.25 euros each.
The continuing major global health crisis related to the Covid-19 epidemic creates an uncertain situation. Even if Onxeo has been little impacted in 2021, it is difficult to measure the repercussions on the Group's activity and financial situation, which will depend on the intensity and duration of this crisis. The Company has put in place appropriate measures to protect its employees and to ensure the continuity of its operations and will adapt them as circumstances require. In particular, the Company set up a teleworking organization for all its employees in 2021 and did not make use of the short-time working scheme. In terms of financing, the Company negotiated and obtained state-backed loans in early 2021 for an amount of 5 million euros, enabling it to cope with a possible shift in its activities.
The Group believes that this conflict, which began in February 2022, will have no impact on its business.
| In thousands of euros | 12/31/2020 | Increase | Decrease | 12/31/2021 |
|---|---|---|---|---|
| Beleodaq® R&D assets | 61,830 | 0 | 0 | 61,830 |
| AsiDNA™ R&D assets | 3,259 | 0 | 0 | 3,259 |
| Goodwill | 4,449 | 0 | 0 | 4,449 |
| Other intangible assets | 425 | 0 | 0 | 425 |
| Gross TOTAL | 69,964 | 0 | 0 | 69,964 |
| Beleodaq® amortization | -8,227 | 0 | 0 | -8,227 |
| AsiDNA™ amortization | 0 | 0 | 0 | 0 |
| Amortization of other intangible assets | -421 | -4 | 0 | -425 |
| TOTAL Depreciation and amortization | -8,648 | -4 | 0 | -8,652 |
| Beleodaq® Depreciation | -53,603 | 0 | 0 | -53,603 |
| TOTAL Impairments | -53,603 | 0 | 0 | -53,603 |
| Total | 7,712 | -4 | 0 | 7,709 |
Gross intangible assets consist mainly of:
Development costs for the product Beleodaq® (belinostat), amounting to 61,830 thousand euros, recognized at the time of the acquisition by merger of the company Topotarget in 2014. In accordance with the license agreement signed with Acrotech Biopharma on April 6, 2020, Onxeo will no longer benefit from any future revenues related to Beleodaq®/belinostat, other than what is required to repay the bond loan contracted with SWK Holdings, and consequently these R&D assets were fully depreciated at December 31, 2020.
Development costs for the product AsiDNA™ in the amount of 3,259 thousand euros, recognized upon the acquisition of DNA Therapeutics in 2016.
The R&D assets, corresponding to AsiDNA™, being unamortized, as well as the goodwill, were tested for impairment at December 31, 2021, as described below.
The value in use of these assets has been determined using the projected cash flow method, on the basis of a 20-year financing plan prepared by management and representing its best estimate. This financing plan takes notably into account a model of future sales of products under development and includes probabilities of success. The valuation model does not include a terminal value, as all foreseeable cash flows are included within the time horizon chosen. A discount rate of 15.7% has been applied to the cash flows, integrating the market risk and the specific risks related to Onxeo. As the value in use obtained for AsiDNA™ exceeded the bases tested, no impairment was recognized.
The Company has determined the recoverable amount of goodwill as the higher of fair value less exit costs and value in use. The fair value was assessed by reference to the market capitalization of Onxeo on December 31, 2021. Costs of disposal were considered non-significant. At the closing date, the market capitalization is higher than the tested basis (net book value at that date). Therefore, no impairment has been recorded. In order to support this result, the Group has, in a second step, determined its value in use on the basis of a 20-year financing plan prepared by the management and representing its best estimate. This financing plan takes notably into account a model of future sales of products under development and includes probabilities of success. The valuation model does not include a terminal value, as all foreseeable cash flows are included within the time horizon chosen. These cash flows include all revenues and expenses related to the indications currently in the portfolio, including potential developments on products developed by the Group. A discount rate of 15.7% has been applied to the cash flows, integrating the market risk and the specific risks related to Onxeo. The value in use thus determined is also higher than the basis tested (net book assets at December 31, 2021).
The goodwill has not been subject to sensitivity testing to the extent that its recoverable amount is significantly higher than the carrying amount.
Regarding R&D assets related to AsiDNA™, the Group implemented a sensitivity testing by varying the discount rate used for the model. The table below presents the corresponding potential levels of impairment.
| In million Euros | |
|---|---|
| Variation of the discount rate | |
| +0,5% | 0 |
| +1% | 0 |
| +1,5% | -1.1 |
| +2% | -2.6 |
| +2,5% | -3.3 |
| +3% | -3.3 |
Tangible fixed assets consist mainly of laboratory and research equipment, computer hardware and other fixtures and fittings acquired by the company.
Financial assets correspond mainly to the investments held by Onxeo in its subsidiaries. The change in this item corresponds mainly to reversals of and charges to provisions for impairment in value of shares in subsidiaries, for a net amount of 775 thousand euros.
The amount of treasury shares held under the liquidity contract as of December 31 2021 is 181 thousand euros corresponding to 429,850 shares recorded under "Other long-term investments". Cash not invested under the contract amounted to 37 thousand euros.
Trade receivables represent a net amount of 597 thousand euros at December 31, 2021. Non-group accounts receivable consist mainly of receivables relating to royalties on sales of Beleodaq® under the license agreement with Acrotech Biopharma.
| In thousands of € | 12/31/2021 | < 1 year | > 1 year | 12/31/2020 |
|---|---|---|---|---|
| Current accounts of subsidiaries | 8,041 | 8,041 | 3,116 | |
| Receivables from Vectans | 693 | |||
| Research tax credit | 1,745 | 1,745 | 1,123 | |
| Other tax receivables (VAT) | 504 | 504 | 447 | |
| Other receivables | 13 | 13 | 20 | |
| Net value of Other receivables | 10,303 | 2,262 | 8,041 | 5,399 |
The increase in current accounts of subsidiaries for 3,905 thousand euros is mainly linked to a reversal of the provision for depreciation of the current account of the subsidiary Topotarget Switzerland, for an amount of 3,602 thousand euros, as a consequence of the revenues received by this company in 2021 and the improvement of its net situation, as well as to a translation difference of current accounts in foreign currencies for 1,206 thousand euros.
The receivable from Vectans Pharma of 693 thousand euros at December 31, 2020, corresponding to a contractual license fee, was collected in early 2021.
At December 31, 2021, cash and cash equivalents amounted to 17,371 thousand euros, including term accounts of 12,302 thousand euros.
The increase in net cash of 2.9 million euros over the year is mainly related to the company's operating expenses, notably in research and development, for an amount of 13.5 million euros, offset by the receipt of license revenues for 0.8 million euros. In terms of financing, the Company obtained state-backed loans of 5 million euros and implemented a capital increase for a net amount of 9.4 million euros. Finally, the Company benefited from the reimbursement of its 2020 research tax credit for an amount of 1.1 million euros.
Prepaid expenses at December 31 2021 amounted to 1,440 thousand euros and correspond mainly to industrial subcontracting services, as well as fees and rent for the head office in the first quarter of 2022.
At December 31 2021, the capital amounted to 22,999 thousand euros, divided into 91,994,935 ordinary shares with a par value of €0.25 each, all of the same class and fully paid up.
During the year, the share capital changed as follows:
| Nominal | Nb Shares | € | ||
|---|---|---|---|---|
| Fully paid-up shares as of 12/31/2020 | 0.25 | 78,317, 810 | 19,579,452.50 | |
| Capital increase | (1) | 0.25 | 13,677,125 | 3,419, 281.25 |
| Fully paid-up shares as of 12/31/2021 | 0.25 | 91,994,935 | 22,998,733.75 |
(1) Issuance of 13,677,125 new shares with a par value of 0.25 euro each at a price of 0.71 euro as part of a global capital increase with preferential subscription rights, corresponding to an increase in share capital of 3,419 thousand euros with a net issue premium of 5,924 thousand euros.
The share premium account increased from 5,278 thousand euros to 11,284 thousand euros as a result of the issue premiums from the capital increase described above and the subscription of warrants for an amount of 82 thousand euros.
Other shareholders' equity in the amount of 164 thousand euros corresponds to:
The item includes provisions for foreign exchange risk related to the translation difference liability on the SWK loan for 226 thousand euros and provisions for litigation for a total amount of 200 thousand euros.
The Company issued bonds to SW Holdings in June 2018 for an initial amount of \$7.5 million. This debt, for a total amount of 13.5 million dollars, is being repaid through royalties on sales of Beleodaq® paid by the American partner Acrotech Biopharma. The remaining capital due as of December 31, 2021 amounts to 2,771 thousand euros and the accrued interest amounted to 300 thousand euros. The Company considers it highly probable that this bond will be fully repaid within less than one year.
Trade payables increased from 3 240 thousand euros at December 31, 2020 to 3,071 thousand euros at December 31, 2021, in line with the change in R&D expenditure.
It is specified that the Company conducts preclinical and clinical research and contracts with external partners who assist Onxeo in its studies. For clinical trials, research expenses accrued at year-end are determined based on management's estimates of costs not yet billed per patient. These estimates are based on information provided by the contracted investigating centers (hospitals) and cost analyses performed by management.
| In thousands of € | 12/31/2021 | 12/31/2020 |
|---|---|---|
| Social security liabilities | 593 | 802 |
| Tax liabilities | 55 | 460 |
| Total | 648 | 1,262 |
The change in social security liabilities is mainly due to the reduction in variable compensation for the year 2021.
The decrease in tax liabilities is due to the payment during the year of a tax for the year 2020 by the Danish branch of Onxeo S.A., in the amount of 329 thousand euros.
This item of 10,599 thousand euros corresponds to the current account in credit of the subsidiary Topotarget UK for an amount of 5,764 thousand euros and to the debt to SpePharm related to the settlement agreement signed by the Company on February 11, 2020 for an amount of 4,829 thousand euros. This debt will be repaid in the form of a 20% share of the amounts received under the license agreements entered into by Onxeo or its subsidiaries, and the residual amount at January 31, 2024 will be paid in full at that date.
Revenues for the year 2021 for an amount of 46 thousand euros is mainly due to intra-group re-invoicing.
Royalties on Beleodaq sales under the license agreement with Acrotech were recognized during the year for an amount of 1,828 thousand euros.
This item mainly includes a reversal of the provision for depreciation of the current account of the subsidiary Topotarget Switzerland, in the amount of 3,602 thousand euros, as a result of the income received by this company in 2021 and the improvement in net worth
External expenses increased from 5,746 thousand euros at December 31, 2020 to 6,519 thousand euros at December 31 2021, in particular due to the increase in R&D costs, which amounted to 3,165 thousand euros, compared with 2,190 thousand euros in the previous year. This change is essentially related to the clinical development of AsiDNA and the optimization and preclinical development of OX400 family compounds.
Personnel costs decreased from 4,032 thousand euro in 2020 to 3,818 thousand euro in 2021. This change is mainly due to the decrease in variable employee remuneration.
Financial income mainly includes a reversal of impairment of the shares of the subsidiaries Topotarget Switzerland and Topotarget UK for a total of 775 thousand euros, foreign exchange gains and reversals of provisions for foreign exchange differences for a total of 49 thousand euros, as well as interest on inter-company current accounts.
Financial expenses include interest on the SWK bond in the amount of 847 thousand euros. Financial expenses also include interest on inter-company current accounts for a total of 269 thousand euros, as well as exchange losses or provisions for exchange losses for 227 thousand euros.
The negative extraordinary result of 23 thousand euros corresponds mainly to: Donations to research institutions amounting to 143 thousand euros; A reversal of a provision for litigation in the amount of 127 thousand euros.
This item is a result of 1 745 thousand euros which corresponds to the French and Danish research tax credits.
Onxeo had a French loss carry-forward of 304 million euros at December 31 2021.
The actuarial valuation method used for pension obligations is the retrospective valuation method. Under this method, the present value of benefits is determined on the basis of services rendered by the employee at the valuation date. This is a defined benefit plan.
The actuarial assumptions used are as follows: Collective agreement: National Agreement of Pharmaceutical Companies Retirement age: From the age of 65, in application of the law of November 10, 2010 on pension reform Calculation date: 31/12/2021 Mortality table: INSEE 2021 Discount rate: 1.12 % Salary escalation rate: (rate of salary increase + inflation) 2% Turnover rate: By age structure Payroll tax rates: 46 %
As at December 31 2021, pension commitments amounted to 607 thousand euros.
Lease commitments amounted to 320 thousand euros as of December 31 2021.
Compensation paid to corporate officers amounted to 965 thousand euros, including pension benefits for the Chief Executive Officer in the amount of 172 thousand euros.
The parties related to Onxeo SA are:
Transactions with other companies related to the Group concern exclusively the companies included in the scope of consolidation. These mainly consist of sales of finished products and services, invoicing of marketing license fees and intra-group loans and borrowings under cash management agreements.
The table below shows the impact of intra-group transactions as of December 31, 2021 :
| in thousands of € | 31/12/2021 | 12/31/2020 |
|---|---|---|
| Assets | 76,437 | 74,996 |
| Liabilities | 6,271 | 5,468 |
| Revenues | 43 | 9 |
| Charges | 899 | 1,229 |
The amount of the assets corresponds mainly to the current account of the subsidiary Topotarget Switzerland and to the equity investments, the amount of the liabilities to the current account of the subsidiary Topotarget UK and to the debts towards the US subsidiary.
| In thousands of euros | Start amount 2021 |
Increases | Decreases | End amount 2021 |
|---|---|---|---|---|
| Start-up and development costs |
65 089 | 65 089 | ||
| Other intangible asset items |
4 875 | 4 875 | ||
| TOTAL INTANGIBLE ASSETS |
69 965 | 69 965 | ||
| Land | ||||
| Buildings on own land | ||||
| Buildings on third party land |
||||
| General installations, building fixtures and fittings |
||||
| Technical installations, equipment and industrial tools |
1 317 | 29 | 1 346 | |
| General installations, miscellaneous fittings and fixtures |
1 464 | 109 | 1 573 | |
| Transport equipment | ||||
| Office equipment and computer furniture |
362 | 362 | ||
| Recoverable and miscellaneous packaging |
||||
| Tangible assets in progress |
||||
| Advances and down payments |
||||
| TOTAL TANGIBLE ASSETS | 3 143 | 137 | 3 281 | |
| Investments accounted for using the equity method |
||||
| Other investments | 48 578 | 48 578 | ||
| Other long-term securities |
182 | 1 | 181 | |
| Loans and other financial assets |
226 | 2 | 73 | 155 |
| TOTAL FINANCIAL FIXED ASSETS |
48 986 | 2 | 74 | 48 914 |
| GENERAL TOTAL | 122 094 | 139 | 74 | 122 159 |
| In thousands of euros | Amount beginning 2021 |
Increases | Decreases | Amount end 2021 |
|---|---|---|---|---|
| Establishment, research and development costs |
8,227 | 8,227 | ||
| Other intangible asset items | 422 | 4 | 425 | |
| TOTAL INTANGIBLE ASSETS | 8,649 | 4 | 8,652 | |
| Land | ||||
| Buildings on own land | ||||
| Buildings on third party land | ||||
| General installations, building fixtures and fittings |
||||
| Technical installations, equipment and industrial tools. |
1 110 | 22 | 1 132 | |
| General installations, fixtures and fittings |
1 431 | 17 | 1 448 | |
| Transport equipment | ||||
| Office and computer equipment, furniture |
361 | 361 | ||
| Recoverable and miscellaneous packaging |
||||
| TOTAL TANGIBLE ASSETS | 2 902 | 39 | 2 942 | |
| GENERAL TOTAL | 11,551 | 43 | 11,594 |
| Decreases: | ||||||
|---|---|---|---|---|---|---|
| Amount | Increases | Used | Unused | Reversals | Amount | |
| In thousands of euros | beginning2021 | Allocations for the year |
during the | during the | during the | end 2021 |
| year | year | year | ||||
| Regulated provisions | ||||||
| Provisions for reconstruction of deposits | ||||||
| (mines, oil) | ||||||
| Provisions for investment | ||||||
| Provisions for price increases | ||||||
| Excessive depreciation | ||||||
| Of which exceptional increases of 30%. | ||||||
| -Provisions for installation loans | ||||||
| Other regulated provisions | ||||||
| TOTAL REGULATED PROVISIONS | ||||||
| Provisions for liabilities and charges | ||||||
| Provisions for disputes | ||||||
| Provisions for guarantees given to customers | ||||||
| Provisions for losses on futures markets | ||||||
| Provisions for fines and penalties | ||||||
| Provisions for foreign exchange losses | 37 | 226 | 37 | 226 | ||
| Provisions for pensions and similar obligations | ||||||
| Provisions for taxes | ||||||
| Provisions for renewal of fixed assets | ||||||
| Provisions for major maintenance and | ||||||
| overhauls | ||||||
| Provisions for social and tax charges on leave | ||||||
| payable | ||||||
| Other provisions for liabilities and charges | 327 | 127 | 200 | |||
| TOTAL PROV. FOR LIABILITIES AND | 363 | 226 | 163 | 426 | ||
| CHARGES | ||||||
| Provisions for depreciation | ||||||
| On intangible fixed assets | 53 603 | 53 603 | ||||
| On tangible fixed assets On capitalization of equity method |
158 | 158 | ||||
| investments | ||||||
| On capitalization of equity investments | 43 522 | - | 775 | 42 746 | ||
| On other financial assets | ||||||
| On stock and work in progress | ||||||
| On accounts receivable | ||||||
| Other provisions for impairment | 23 302 | 118 | 3 602 | 19 819 | ||
| TOTAL PROVISIONS FOR DEPRECIATION | 120 585 | 118 | 4 377 | 116 327 | ||
| GENERAL TOTAL | 120 949 | 313 | 4 540 | 116 753 | ||
| Of which operating allowances and reversals | 118 | 3 602 | ||||
| Of which financial allowances and reversals | 226 | 812 | ||||
| Of which exceptional allowances and reversals | 127 | |||||
| In thousands of euros | Gross amount | Up to 1 year | Over 1 year |
|---|---|---|---|
| Receivables related to investments | |||
| Loans (1) (2) | |||
| Other financial fixed assets | 155 | 155 | |
| Total fixed assets | 155 | 155 | |
| Doubtful or contentious clients | |||
| Other trade receivables | 597 | 597 | |
| Receivables representing loaned securities | |||
| Staff and related accounts | 7 | 7 | |
| Social security and other social organizations | 6 | 6 | |
| Income taxes | 1 745 | 1 745 | |
| Value Added Tax | 317 | 317 | |
| Other taxes and similar payments | |||
| Miscellaneous | 188 | 188 | |
| Group and Associates (2) | 27 859 | 27 859 | |
| Miscellaneous debtors | |||
| Total current assets | 30 719 | 30 719 | |
| Prepaid expenses | 1 440 | 1 440 | |
| TOTAL RECEIVABLES | 32 314 | 32 159 | 155 |
| (1) Amount of loans granted during the year | |||
| (1) Amount of repayments obtained during the year | |||
| (2) Loans and advances to partners (legal entities) |
| In thousands of euros | Gross amount |
Up to 1 year | More than 1 year up to 5 years |
Over 5 years |
||
|---|---|---|---|---|---|---|
| Convertible bonds (1) | ||||||
| Other bonds (1) (A) | 2 771 | 2 771 | ||||
| Loans and debts from credit institutions up to one year |
5 006 | 6 | 4,706 | 294 | ||
| Loans and debts from credit institutions of more than one year |
||||||
| Other loans and financial liabilities (1) (2) | 464 | 464 | ||||
| Trade payables and related accounts | 3 071 | 3 071 | ||||
| Staff and related accounts | 297 | 297 | ||||
| Social security and other social organizations | 295 | 295 | ||||
| Income taxes | 205 | 205 | ||||
| Value Added Tax | 1 | 1 | ||||
| Guaranteed Bonds | ||||||
| Other taxes and similar | 53 | 53 | ||||
| Debts on fixed assets and related accounts | ||||||
| Group and Associates (2) | 5 764 | 5 764 | ||||
| Other liabilities | 10 599 | 10 599 | ||||
| Debt on borrowed securities | ||||||
| Deferred revenue | ||||||
| TOTAL LIABILITIES | 28 323 | 23 323 | 4,706 | 294 | ||
| (1) Borrowings taken out during the year | 5,000 | |||||
| (1) Borrowings repaid during the year | ||||||
| (2) Amount of loans and debts due to partners |
The other bonds consist mainly of the loan granted by SW Holdings. As its reimbursement is linked to the royalties paid by the Spectrum partner, it is not possible to indicate with certainty the breakdown of the reimbursement over time.
| In thousands of euros | 2021 | 2020 |
|---|---|---|
| Financial fixed assets | ||
| Receivables related to investments | ||
| Other financial fixed assets | ||
| Total financial fixed assets | ||
| Receivables | ||
| Trade receivables and related accounts | 597 | 496 |
| Other receivables | 193 | 789 |
| Total receivables | 790 | 1 285 |
| Cash and miscellaneous | ||
| Marketable securities | ||
| Liquid assets | ||
| Total cash and miscellaneous | 1 | |
| TOTAL | 791 | 1 285 |
| In thousands of euros | 2021 | 2020 |
|---|---|---|
| Financial liabilities | ||
| Convertible bonds | ||
| Other debenture loans | 300 | 220 |
| Borrowings and debts with credit institutions | ||
| Miscellaneous borrowings and financial liabilities | ||
| Advances and deposits received on orders in progress | ||
| Total financial liabilities | 300 | 220 |
| Operating liabilities | ||
| Trade payables and related accounts | 2 793 | 3 001 |
| Tax and social security liabilities | 488 | 661 |
| Total operating liabilities | 3 281 | 3 662 |
| Miscellaneous liabilities | ||
| Debts on fixed assets and related accounts | ||
| Other debts | ||
| Total operating liabilities | ||
| TOTAL | 3 581 | 3 882 |
| In thousands of euros |
01/01/2021 | Capital increase | Capital decrease |
Allocation of 2020 results |
Other movements |
Result 2021 |
31/12/2021 |
|---|---|---|---|---|---|---|---|
| Social or individual capital |
19 579 | 3 419 | 22 999 | ||||
| Share premium, merger premium, contribution premium |
5 278 | 5 924 | 11 284 | ||||
| Revaluation differences |
|||||||
| Legal reserve | |||||||
| Statutory or contractual reserves. |
|||||||
| Regulated reserves | |||||||
| Other reserves | |||||||
| Carry forward | (9 347) | (3 567) | (12 913) | ||||
| Result for the year | (3 567) | 3 567 | (4 332) | (4 332) | |||
| Investment subsidies |
|||||||
| Regulated provisions |
|||||||
| Dividends paid | |||||||
| .TOTAL | 11 944 | 9 343 | (4 332) | 17 037 |
| LEASED FIXED ASSETS | Initial cost | Depreciation and amortization | Cumulative net | |
|---|---|---|---|---|
| (in thousands of euros) | for the | year | value | |
| Land | ||||
| Constructions | ||||
| Technical installations, equipment, tools |
506 | 78 | 221 | 285 |
| Other tangible assets | 45 | 9 | 9 | 36 |
| Assets under construction |
||||
| TOTAL | 551 | 88 | 230 | 321 |
| LEASE | Royalties paid | Outstanding royalties | Cumulative | ||||
|---|---|---|---|---|---|---|---|
| COMMITMENTS (in thousands of euros) |
for the | year | up to 1 year |
from 1 to 5 years |
more than 5 years |
Total | residual purchase price |
| Land | |||||||
| Constructions | |||||||
| Technical installations, |
92 | 249 | 71 | 177 | 248 | 2 | |
| Other tangible fixed assets |
9 | 9 | 11 | 24 | 36 | ||
| Assets under construction |
|||||||
| TOTAL | 102 | 258 | 82 | 201 | 283 | 3 |
| Categories | Average number of employees |
Average number of staff made available |
Total | ||||
|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | 2021 | 2020 | ||
| Executives | 24 | 21 | 24 | 21 | |||
| Supervisors | |||||||
| Employees and technicians |
1 | 4 | 1 | 4 | |||
| Total | 25 | 25 | 25 | 25 |
| Amount for related | ||||
|---|---|---|---|---|
| In thousands of euros | companies | with which the company has an equity interest |
||
| Financial fixed assets | ||||
| Advances and deposits on fixed assets | ||||
| Shareholdings | 48 578 | |||
| Receivables related to investments | ||||
| Loans | ||||
| Total financial fixed assets | 48 578 | |||
| Receivables | ||||
| Advances and deposits paid on orders | ||||
| Trade receivables and related accounts | ||||
| Other receivables | 27 859 | |||
| Subscribed capital called but not paid | ||||
| Total receivables | 27 859 | |||
| Convertible bonds | ||||
| Other debenture loans | ||||
| Borrowings and debts with credit institutions | ||||
| Miscellaneous borrowings and financial liabilities | ||||
| Advances and deposits received on current orders | ||||
| Trade payables and related accounts | 507 | |||
| Other liabilities | 5 764 | |||
| Total liabilities | 6 271 | |||
| Financial elements | ||||
| Income from investments | ||||
| Other financial income | 4 | |||
| Financial expenses | 269 | |||
| Total financial elements | (273) | |||
| Other | 591 |
| Companies | Capital | Share of capital held (in %) |
Book value of securities held |
Loans and advances granted by the |
Result (profit or loss for the last fiscal |
||
|---|---|---|---|---|---|---|---|
| Gross | Net | company and not yet repaid |
year) | ||||
| Topotarget Switzerland | 92 | 100 | 9,918 | 0 | 26,945 | 3,440 | |
| Topotarget UK | 1,606 | 100 | 38,659 | 5,831 | (5,764) | 421 | |
| ONXEO US | 1 | 100 | 1 | 0 | 914 | (157) | |
| Total | 48,578 | 5,831 | 22,095 | 3,704 |
French member of Grant Thornton International 29, rue du Pont - CS 20070 92200 Neuilly-sur-Seine S.A.S. with a capital of € 2, 297,184 632 013 843 R.C.S. Nanterre
Statutory Auditor Member of the Versailles and Centre regional company
First Tower TSA 14444 92037 Paris-La Défense cedex S.A.S. with variable capital 344 366 315 R.C.S. Nanterre
Statutory Auditor Member of the Versailles and Centre regional company
Onxeo Year ended 31 December 2021
This is a translation into English of the statutory auditor's report on the financial statements of the Company issued in French and it is provided solely for the convenience of English speaking users.
This statutory auditor's report includes information required by European regulation and French law, such as information about the verification of the management report and other documents provided to shareholders.
This report should be read in conjunction with, and construed in accordance with, French law and professional auditing standards applicable in France.
To the General Meeting of Shareholders
In compliance with the engagement entrusted to us by your general meeting of shareholders, we have audited the accompanying financial statements of Onxeo for the year ended 31 December 2021.
In our opinion, the financial statements give a true and fair view of the assets and liabilities and of the financial position of the company as at 31 December 2021 and of the results of its operations for the year then ended in accordance with French accounting principles.
We conducted our audit in accordance with professional standards applicable in France. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
Our responsibilities under those standards are further described in the Statutory Auditors' Responsibilities for the Audit of the Financial Statements section of our report.
We conducted our audit engagement in compliance with independence requirements of the French Commercial Code (Code de commerce) and the French Code of Ethics for Statutory Auditors (Code de déontologie de la profession de commissaire aux comptes) for the period from 1 January 2021 to the date of our report.
Due to the global crisis related to the COVID-19 pandemic, the financial statements for this accounting period have been prepared and audited under special circumstances. Indeed, this crisis and the exceptional measures taken in the context of the health emergency have had numerous consequences for companies, particularly on their operations and their financing, and have led to greater uncertainties regarding their future prospects. These measures, such as travel restrictions and remote working, have also had an impact on companies' internal organization and on how audits are performed.
It is in this complex, evolving context that, in accordance with the requirements of Articles L. 823-9 and R. 823-7 of the French Commercial Code (Code de commerce) relating to the justification of our assessments, we inform you of the key audit matters relating to risks of material misstatement that, in our professional judgment, were of most significance in our audit of the financial statements of the current period.
These matters were addressed in the context of our audit of the financial statements as a whole and in forming our opinion thereon, and we do not provide a separate opinion on specific items of the financial statements.
With regard to the intangible assets relating to R&D and goodwill, as stated in Note 3.1 "Intangible assets" to the financial statements, the valuation used as a reference for the impairment tests corresponds to the recoverable value, which is the higher of the fair value net of disposal costs or the value in use. We examined the conditions for implementation of the impairment tests and the data used by the Group's Management. We verified that Note 3.1 "Intangible assets" provides appropriate information on this matter.
We have also performed, in accordance with professional standards applicable in France, the specific verifications required by the laws and regulations.
We have no matters to report as to the fair presentation and the consistency with the financial statements of the information given in the management report of the Board of Directors and in the other documents with respect to the financial position and the financial statements provided to the shareholders.
We attest the fair presentation and the consistency with the financial statements of the information relating to payment deadlines mentioned in Article D. 441-6 of the French Commercial Code (Code de commerce).
We attest that the Board of Directors' Report on Corporate Governance sets out the information required by Article L. 225-37-4 of the French Commercial Code (Code de commerce).
In accordance with French law, we have verified that the required information concerning the purchase of investments and controlling interests and the identity of the shareholders and holders of the voting rights has been properly disclosed in the management report.
Management is responsible for the preparation and fair presentation of the financial statements in accordance with French accounting principles and for such internal control as management determines is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.
In preparing the financial statements, management is responsible for assessing Onxeo's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless it is expected to liquidate the Company or to cease operations.
The financial statements were approved by the Board of Directors.
Our role is to issue a report on the financial statements. Our objective is to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with professional standards will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these financial statements.
As specified in Article L. 823-10-1 of the French Commercial Code (Code de commerce), our statutory audit does not include assurance on the viability of the Company or the quality of management of the affairs of the Company.
As part of an audit conducted in accordance with professional standards applicable in France, the statutory auditor exercises professional judgment throughout the audit and furthermore:
Neuilly-sur-Seine et Paris-La Défense, 28 April 2022
The Statutory Auditors (French original signed by)
GRANT THORNTON French member of Grant Thornton International ERNST & YOUNG Audit
Samuel Clochard Franck Sebag
PREPARED IN ACCORDANCE WITH IFRS

| CONSOLIDATED BALANCE SHEET ________95 | |||
|---|---|---|---|
| CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME __________96 | |||
| CONSOLIDATED STATEMENT OF CHANGES IN EQUITY _________97 | |||
| CONSOLIDATED STATEMENT OF NET CASH FLOWS______98 | |||
| NOTE 1 - | PRESENTATIONS OF THE GROUP ___________99 | ||
| NOTE 2 - | SIGNIFICANT EVENTS AND TRANSACTIONS _________99 | ||
| 2.1. | R&D programs99 | ||
| 2.2. | Funding100 | ||
| 2.3. | Impacts of the health crisis100 | ||
| 2.4. | Events subsequent to December 31, 2021 101 | ||
| NOTE 3 - | ACCOUNTING PRINCIPLES, RULES AND METHODS ________101 | ||
| 3.1. | Basis of preparation of the financial statements 101 | ||
| 3.2. | Scope of consolidation102 | ||
| 3.3. | Segment information102 | ||
| 3.4. | Effects of changes in foreign exchange rates 102 | ||
| 3.5. | Intangible fixed assets103 | ||
| 3.6. | Tangible assets 104 | ||
| 3.7. | Financial assets104 | ||
| 3.8. | Stocks105 | ||
| 3.9. | Share-based payments 105 | ||
| 3.10. | Non-current liabilities105 | ||
| NOTE 4 - | RISK MANAGEMENT OF FINANCIAL INSTRUMENTS (IFRS7)________108 | ||
| 4.1. | Liquidity risk 108 | ||
| 4.2. | Credit risk 108 | ||
| 4.3. | Financial counterparty risk 108 | ||
| 4.4. | Foreign exchange risk 108 | ||
| 4.5. | Rate risk 108 | ||
| NOTE 5 - | INTANGIBLE FIXED ASSETS _________108 | ||
| 5.1. | Impairment test109 | ||
| 5.2. | Other information 110 | ||
| NOTE 6 - | TANGIBLE FIXED ASSETS AND RIGHTS OF USE ______110 | ||
| 6.1. | Tangible assets 110 | ||
| 6.2. | Rights of use 111 | ||
| NOTE 7 - | OTHER FINANCIAL FIXED ASSETS __________111 | ||
| NOTE 8 - | CURRENT ASSETS __________111 | ||
| 8.1. | Accounts receivable111 | ||
| 8.2. | Other receivables 112 | ||
| 8.3. | Cash and cash equivalents112 |

| NOTE 9 - | SHAREHOLDERS' EQUITY __________112 | |
|---|---|---|
| 9.1. | Share capital and premiums112 | |
| 9.2. | Treasury shares 113 | |
| 9.3. | Share premiums and reserves113 | |
| 9.4. | Share-based payments 113 | |
| NOTE 10 - NON-CURRENT LIABILITIES_________118 | ||
| 10.1. | Provisions118 | |
| 10.2. | Non-current financial debts119 | |
| 10.3. | Other non-current liabilities 119 | |
| NOTE 11 - CURRENT LIABILITIES _____________120 | ||
| 11.1. | Short-term borrowings and financial liabilities120 | |
| 11.2. | Trade payables and related accounts120 | |
| 11.3. | Other current liabilities120 | |
| NOTE 12 - FINANCIAL INSTRUMENTS _________121 | ||
| NOTE 13 - OPERATING INCOME AND EXPENSES_______122 | ||
| 13.1. | Revenues122 | |
| 13.2. | Personnel expenses123 | |
| 13.3. | External expenses123 | |
| 13.4. | Other non-recurring operating income and expenses123 | |
| NOTE 14 - FINANCIAL INCOME/LOSS _________123 | ||
| NOTE 15 - TAX _______________124 | ||
| NOTE 16 - EARNINGS PER SHARE ____________125 | ||
| NOTE 17 - OFF-BALANCE SHEET COMMITMENTS ______125 | ||
| 17.1. | Off-balance sheet commitments related to the company's operating activities 125 | |
| 17.2. | Off-balance sheet commitments related to the company's financing 125 | |
| 17.3. | Other commitments related to companies in the scope of consolidation 125 | |
| NOTE 18 - COMPENSATION OF CORPORATE OFFICERS _______125 | ||
| NOTE 19 - RELATED PARTIES __________126 | ||
| NOTE 20 - INTRA-GROUP TRANSACTIONS____________126 |
| ASSETS in €K | 12/31/2021 | 12/31/2020 | Note |
|---|---|---|---|
| Non-current assets | |||
| Intangible fixed assets | 20,531 | 20,534 | 5 |
| Tangible assets | 180 | 83 | 6.1 |
| Rights of use | 2,057 | 2,479 | 6.2 |
| Other financial fixed assets | 162 | 233 | 7 |
| Total non-current assets | 22,930 | 23,329 | |
| Current assets | |||
| Trade receivables and related accounts | 8,526 | 6,654 | 8.1 |
| Other receivables | 3,721 | 2,000 | 8.2 |
| Cash and cash equivalents | 17,887 | 14,523 | 8.3 |
| Total current assets | 30,133 | 23,177 | |
| TOTAL ASSETS | 53,063 | 46,506 |
| LIABILITIES AND SHAREHOLDERS' EQUITY K€ | 12/31/2021 | 12/31/2020 | Note |
|---|---|---|---|
| Shareholders' equity | |||
| Capital | 22,999 | 19,579 | 9.1 |
| Less: Treasury shares | -181 | -182 | 9.2 |
| Share premium | 24,583 | 18,577 | 9.3 |
| Reserves | -8,522 | -10,027 | 9.3 |
| Earnings | -5,937 | 1,089 | |
| Total shareholders' equity | 32,942 | 29,036 | |
| Non-current liabilities | |||
| Provisions | 1,508 | 1,640 | 10.1 |
| Deferred tax liability | 204 | 415 | 15 |
| Non-current financial debts | 5,082 | 2,498 | 10.2 |
| Non-current lease liabilities | 1,428 | 1,780 | 10.2 |
| Other non-current liabilities | 4,835 | 5,089 | 10.3 |
| Total non-current liabilities | 13,057 | 11,423 | |
| Current liabilities | |||
| Short-term borrowings and financial liabilities | 2,953 | 1,502 | 11.1 |
| Current lease liabilities | 471 | 477 | 11.1 |
| Trade payables and related accounts | 2,832 | 2,762 | 11.2 |
| Other current liabilities | 807 | 1,306 | 11.3 |
| Total current liabilities | 7,063 | 6,047 | |
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 53,063 | 46,506 |

| In K€ | 12/31/2021 | 12/31/2020 | Note | |||
|---|---|---|---|---|---|---|
| Recurring revenues from licensing agreements | 233 | 1,077 | ||||
| Non-recurring revenues from licensing agreements | 3,829 | 699 | ||||
| Total revenues | 4,062 | 1,776 | 13.1 | |||
| Purchases | -368 | -347 | ||||
| Personnel expenses | -3,984 | -4,265 | 13.2 | |||
| External expenses | -4,131 | -3,882 | 13.3 | |||
| Taxes and duties | -99 | -176 | ||||
| Net depreciation, amortization and provisions | -468 | -618 | ||||
| Other current operating expenses | -672 | -515 | ||||
| Operating expenses | -9,722 | -9,803 | ||||
| Other current operating income and expenses | 78 | 213 | ||||
| Current operating income | -5,582 | -7,814 | ||||
| Other non-current operating income | 439 | 13,500 | 13.4 | |||
| Other non-current operating expenses | -3,492 | 13.4 | ||||
| Share of income from equity affiliates | ||||||
| Operating result after share of income from equity affiliates | -5,143 | 2,194 | ||||
| Net cost of financial debt | -840 | -958 | ||||
| Other financial income | 513 | 1,006 | ||||
| Other financial expenses | -366 | -395 | ||||
| Financial income | -693 | -347 | 14 | |||
| Tax expenses | -100 | -757 | 15 | |||
| - of which deferred taxes |
211 | -415 | ||||
| Consolidated net income | -5,937 | 1,089 | ||||
| Earnings per share | -0.07 | 0.01 | 16 | |||
| Diluted earnings per share | -0.07 | 0.01 | 16 |
| In K€ | 12/31/2021 | 12/31/2020 | Note |
|---|---|---|---|
| Result for the period | -5,937 | 1,089 | |
| Currency translation adjustments | 218 | -71 | |
| Other items recyclable as a result | 218 | -71 | |
| Actuarial gains and losses | 49 | -22 | |
| Other items non-recyclable as a result | 49 | -22 | |
| Other comprehensive income for the period, net of tax | 267 | -93 | |
| Total comprehensive income for the period | -5,670 | 996 | |
| Total comprehensive income attributable to | |||
| the parent company owners | -5,670 | 996 | |
| Minority interests |

Changes in reserves and results
| In K€ | Capital | Treasury shares |
Share premium |
Translation reserves |
Gains and losses recognized in equity |
Consolidated reserves and earnings |
Total Differences |
.TOTAL |
|---|---|---|---|---|---|---|---|---|
| Shareholders' equity at 01/01/2020 | 15,329 | -189 | 44,924 | -34 | -151 | -42,682 | -42,868 | 17,197 |
| Total comprehensive income for the period | -71 | -22 | 1,089 | 996 | 996 | |||
| Capital increase | 4,250 | 6,230 | 188 | 188 | 10,668 | |||
| Treasury shares | 7 | 89 | 89 | 95 | ||||
| Other movements | -32,577 | 14 | 32,562 | 32,577 | ||||
| Share-based payments | 79 | 79 | 79 | |||||
| Shareholders' equity at 12/31/2020 | 19,579 | -182 | 18,577 | -91 | -173 | -8,674 | -8,938 | 29,036 |
| Total comprehensive income for the period | 218 | 49 | -5,937 | -5,670 | -5,670 | |||
| Capital increase | 3,419 | 6,006 | 0 | 9,425 | ||||
| Treasury shares | 1 | -74 | -74 | -73 | ||||
| Other movements | 2 | -1 | -1 | 1 | ||||
| Share-based payments | 224 | 224 | 224 | |||||
| Shareholders' equity at 12/31/2021 | 22,999 | -181 | 24,583 | 127 | -124 | -14,462 | -14,459 | 32,942 |

| K€ | 31/12/2021 | 31/12/2020 | Note |
|---|---|---|---|
| Consolidated net loss | -5,937 | 1,089 | |
| +/- Depreciation, amortization and provisions, net | 511 | -8,215 | 5/6/10 |
| (excluding provisions against working capital) | |||
| +/- Unrealized gain and losses associated with changes in fair value | -182 | -290 | |
| +/- Non-cash income and expenses on stock options and similar items | 224 | 79 | |
| +/- Other calculated income and expenses | |||
| +/- Capital gains and losses on disposal | 57 | ||
| +/- Dilution gains and losses | |||
| +/- Share of equity affiliates | |||
| Gross operating cash flow after cost of net debt and taxes | -5,384 | -7,280 | |
| + Cost of net debt | 848 | 959 | 14 |
| +/- Tax expenses (including deferred taxes) | 100 | 757 | 15 |
| Gross Operating cash flow before cost of net debt and taxes | -4,436 | -5,564 | |
| - Taxes paid | |||
| +/- Changes in operating WCR (including debt related to employee benefits) | -4,136 | 886 | |
| NET CASH FLOW FROM OPERATING ACTIVITIES | -8,572 | -4,678 | |
| - Expenditures on acquisition of tangible and intangible assets | -139 | -119 | |
| + Proceeds of disposal of tangible and intangible assets | 6,116 | ||
| - Expenditures on acquisition of financial assets | |||
| + Proceeds of disposal of financial assets | 73 | 4 | |
| +/- Effect on changes in scope of consolidation | 14 | ||
| + Dividends received (equity affiliates, unconsolidated investments) | |||
| +/- Change in loans and advances granted | |||
| + Capital grants received | |||
| +/- Other changes from investment transactions | |||
| NET CASH FLOW FROM INVESTING ACTIVITIES | -66 | 6,015 | |
| + Net amount received from shareholders on capital increase | |||
| . Paid by shareholders of the parent company | 9,351 | 10,568 | 9 |
| . Paid by minority interest in consolidated companies | |||
| + Amount received on exercise of stock options | |||
| -/+ Purchase and Sale of treasury shares | 1 | 8 | |
| + Amounts received on issuances of new loans | |||
| - Reimbursements of loans (including lease debts) | 2,620 | -3,094 | 10/11/14 |
| o/w repayment of lease debts (IFRS16) | -487 | -475 | |
| +/- Others flows related to financing activities | 4 | -1 | |
| NET CASH FLOW FROM FINANCING ACTIVITIES | 11,976 | 7,481 | |
| +/- Effects of fluctuations in foreign exchange rates | 25 | -3 | |
| CHANGE IN CASH AND CASH EQUIVALENTS | 3,363 | 8,815 | |
| CASH AND CASH EQUIVALENTS AT START OF YEAR | 14,523 | 5,708 | |
| CASH AND CASH EQUIVALENTS AT YEAR END | 17,886 | 14,523 |
Onxeo is a clinical-stage biotechnology company that develops new cancer drugs by targeting tumor DNA functions through mechanisms of action that are unlike any other in the highly sought-after field of DNA damage response (DDR). The Group focuses on the development of innovative first-in-class or disruptive compounds (inhouse, acquired or in-licensed) from translational research to human clinical proof of concept, a value-creating inflection point that is attractive to potential partners.
The Group is based in Paris, France, with offices in Copenhagen and New York, and has approximately 30 employees. The parent company Onxeo is listed on the SME growth markets Euronext Growth in Paris, France, and Nasdaq First North Growth in Denmark.
The consolidated financial statements of Onxeo as of December 31, 2021 were prepared under the responsibility of the Chief Executive Officer and were approved by the Board of Directors on April 6, 2022.
The Group actively pursued preclinical and clinical development of systemic AsiDNA™ in combination with other therapies in various types of solid tumors in 2021 and achieved several major milestones:
After AsiDNA™, Onxeo is developing the OX400 family based on Onxeo's platON™ chemistry platform, which enables the design of new molecules based on oligonucleotides (a double-stranded DNA fragment).

This family of molecules is positioned both in the field of inhibition of the DNA damage response (DDR) and in immuno-oncology.
During the year 2021, the Group continued to optimize OX401 to improve its action on the PARP protein, which is involved in the tumor DNA repair cascade, and its activation of the antitumor immune response via the cGAS-STING pathway. The Group plans to select the optimized compound and start preclinical development in 2022.
On January 28, 2021, the Group announced that it had obtained non-dilutive funding of 5 million euros in the form of Government-Backed Loans. This funding is part of the measures put in place by the French government to support French companies in the context of the COVID-19 pandemic and allows the Company to strengthen its cash position.
The loans are 90% guaranteed by the French government, have interest rates ranging from 0.25% to 1.75%, including the government guarantee, and have a 12-month maturity. After this initial period, the Group may, at its discretion, defer repayment of the principal amount for up to five additional years.
In a press release dated March 10, 2021, Onxeo announced the launch of a capital increase with maintenance of the preferential subscription rights of shareholders in France and Denmark, on the basis of the seventeenth and twentieth resolutions adopted by the extraordinary general meeting of shareholders of June 19, 2020. This operation was the subject of a prospectus approved by the AMF under no. 21-063.
The proceeds of this issue of New Shares are intended to primarily finance the expansion and acceleration of development clinical use of AsiDNA ™, especially in combination with other anti-cancer agents. The Group also intends to continue the optimization and preclinical development of new candidates from the platON ™ platform, optimize pharmaceutical development and compound manufacturing operations, and more generally, finance the activity of the Company.
The main terms of the operation are summarized below:
On April 12, 2021, Onxeo announced the success of this capital increase, with a subscription rate of approximately 104.8%. The gross amount of the capital increase, including share premium, amounts to 9,7 million euros. This transaction extends the Company's cash runway until at least end 2022.
The Company's capital following the capital increase amounts to 22,998,733.75 euros, divided into 91,994,935 shares with a par value of 0.25 euros each.
The continuing major global health crisis related to the Covid-19 epidemic creates an uncertain situation. Even if Onxeo has been little impacted in 2021, it is difficult to measure the repercussions on the Group's activity and financial situation, which will depend on the intensity and duration of this crisis. The Group has put in place appropriate measures for the protection of its employees and to ensure the continuity of its operations and will
adapt them as circumstances require. In particular, the Group has set up a teleworking organization for all its employees in 2021 and has not made use of the short-time working scheme. In terms of financing, the Group negotiated and obtained government-backed loans in early 2021 for an amount of 5 million euros, enabling it to cope with a possible shift in its activities.
The Group believes that this conflict, which began in February 2022, will have no impact on its business.
The consolidated financial statements as of December 31, 2021 have been prepared in accordance with the international accounting standards issued by the International Accounting Standards Board (IASB) as of December 31, 2021, as well as with the international standards as adopted by the European Union as of December 31, 2021.
The standard adopted by the European Commission can be consulted on the following website: https://eurlex.europa.eu/legal-content/FR/TXT/?uri=LEGISSUM%3Al26040
The accounting principles and methods applied in the consolidated financial statements for the year ended December 31, 2021 are identical to those used in the consolidated financial statements for the year ended December 31, 2020, and take into account the IFRS standards, amendments and interpretations as adopted by the European Union and the IASB, which are mandatory for financial years beginning on or after January 1, 2021 (and which have not been applied early by the Group), namely:
| Standard | Heading |
|---|---|
| Amendments to IFRS 4 | Insurance contracts - Extension of the temporary exemption from IFRS 9 |
| Amendments to IFRS 9, IAS 39, IFRS 7, | Reference interest rate reform – phase 2 |
| IFRS 4 and IFRS 16 | |
| Amendments to IFRS 16 | COVID-19 Rent Relief |
The application of these standards, amendments and interpretations does not have a material impact on the Group's consolidated financial statements.
In addition, the other standards, amendments or interpretations published respectively by the IASB and the IFRIC (International Financial Reporting Interpretations Committee) and adopted by the European Union as of December 31, 2021, but whose mandatory application is subsequent to the fiscal year beginning January 1, 2021, have not been applied in advance by the Group: IFRS 17 (Insurance Contracts), amendments to IAS 16 (Revenue from the Sale of Goods Manufactured Before Intended Use), amendments to IAS 37 (Onerous Contracts: Cost of Performance), annual improvements 2018-2020 cycle (amendment to illustrative examples accompanying IFRS 16 relating to lease incentives, amendment to IFRS 9 Financial Instruments / Commissions in the "10%" test for derecognition of financial liabilities, amendment to IAS 41 Agriculture / Taxation in fair value measurements, amendment to IAS 1 First-time Adoption of IFRS / Subsidiary as a first-time adopter), amendments to IFRS 3 (reference to the conceptual framework).
The preparation of financial statements requires management to exercise judgment and to make estimates and assumptions that affect the application of accounting policies and the reported amounts of assets and liabilities, income and expenses. Actual values may differ from estimated values.

The estimates and underlying assumptions are reviewed on an ongoing basis. The impact of changes in accounting estimates is recognized in the period of the change and any subsequent periods affected.
Information about the key sources of estimation and assumption uncertainty and the judgments made in applying the accounting policies that have the most significant effect on the amounts recognized in the consolidated financial statements relate to the following items:
The disclosure of contingent assets and liabilities existing at the date of preparation of the consolidated financial statements is also subject to estimates (see note 17).
The financial statements have been prepared on a going concern basis. This principle was adopted by the Board of Directors on the basis of a consolidated net cash position of 17.9 million euros at December 31, 2021 and financing commitments received from its two main shareholders, Invus and Financière de la Montagne, of at least 12 million euros. The Group can thus finance its activities at least into Q2 2023 based on its financing plan.
The group's companies close their accounts on December 31 of each year.
The scope of consolidation includes the following companies as of December 31, 2021:
All subsidiaries are wholly owned and fully consolidated. Intra-group transactions and balances on transactions between group companies have been eliminated. Where the accounting policies of subsidiaries differ from those of the Group, they are restated in the consolidated financial statements.
The Group constitutes a single business segment. In accordance with IFRS 8.32 and 33, information on the breakdown of revenues by geographic area and product category is provided in note 13.1, In accordance with this standard, the Group's non-current assets are mainly located in France.
The Group's main client, whose share of revenues is greater than 10%, is the company Biogen.
The presentation currency of the consolidated financial statements is the euro, which is also the functional currency of the parent company.
The assets and liabilities of subsidiaries with a functional currency other than the euro are translated into euros at the exchange rates prevailing at the balance sheet date. Income statements are translated at average rates for the year.
Differences arising from the translation of balance sheet and income statement items are recorded in the balance sheet under "Translation differences" in shareholders' equity. When a foreign entity is disposed of, these translation differences are recycled to the income statement under gains and losses on disposal.
Transactions denominated in foreign currencies are translated into euro using the exchange rates prevailing at the dates of the transactions. At the balance sheet date, cash and cash equivalents and operating receivables and payables denominated in foreign currencies are translated into euro at the latest exchange rate for the year. Unrealized gains and losses resulting from this translation are recognized in the income statement for the year.
Patents created by Onxeo are expensed or capitalized in accordance with the treatment of research and development costs explained below.
Patents acquired for valuable consideration by Onxeo are capitalized and amortized. The amortization period generally used by Onxeo is ten years, which corresponds to the estimated useful life.
Research costs are systematically expensed. In particular, in the context of clinical trials conducted by the Group, an estimate of costs not yet invoiced per patient is determined by management on the basis of study follow-up documents and recorded as an expense for the year. Development costs are capitalized when all the conditions required by IAS 38 are met. The company considers that the six criteria set out in IAS 38 are only met once a marketing authorization has been obtained.
Acquired (or contributed) research and development projects are recognized as intangible assets at their acquisition cost, even in the absence of marketing authorization.
In accordance with IAS 38, intangible assets are classified into two categories:
In the context of business combinations, mergers or acquisitions, goodwill corresponds to the difference between the amount of the transaction and the market value of the assets and liabilities acquired.
Goodwill is not amortized and is tested for impairment annually and whenever there is an indication of impairment.
In accordance with IAS 36 "Impairment of Assets":

The Group considers that it comprises a single cash-generating unit (CGU), insofar as the projects it develops belong to the same product family, have overlapping business models and are therefore interdependent. This single CGU includes, in particular, goodwill and R&D assets acquired in connection with the acquisition of DNA Therapeutics (AsiDNA).
These impairment tests consist in comparing their recoverable amount (the higher of fair value net of disposal costs and value in use) with their tested basis. The value in use is determined on the basis of a financing plan prepared by management and representing its best estimate. An impairment loss is recognized when the recoverable amount is less than their tested basis. In addition, sensitivity tests on the key parameters of the financial model used to determine the value in use allow for the identification of potential risks of impairment.
In accordance with IAS 16, tangible fixed assets are carried at cost less accumulated depreciation and impairment losses. Depreciation is calculated using the straight-line method.
The most commonly used amortization periods are as follows:
Tangible fixed assets are tested for impairment whenever there is an indication that they may be impaired.
Financial assets included in the scope of IFRS 9 are classified as financial assets at fair value through profit or loss, financial assets measured at amortized cost or financial assets measured at fair value through other comprehensive income.
Non-current financial assets include financial assets, in particular:
Current financial assets include trade receivables, other current assets, and cash and cash equivalents. Cash and cash equivalents include cash in current bank accounts. Cash equivalents include money market funds and mutual funds, which can be converted or sold in the short term into a known amount of cash and are subject to an insignificant risk of change in value.
These assets are accounted for according to their nature, based on the following rules:
Financial assets at fair value through profit or loss include financial instruments that are designated as being measured at fair value through profit or loss on initial recognition, in accordance with the conditions for the application of the fair value option, or that are managed and whose performance is measured on the basis of fair value, or that are managed in trading. Instruments that do not meet the SPPI test, such as units of funds / UCITS, are also included in this item.
This item includes units in cash UCITS, which can be sold or transferred in the very short term and do not present a significant risk of loss of value in the event of changes in interest rates.
These assets are classified in the balance sheet as cash and cash equivalents. They are recorded at fair value without deduction of transaction costs that may be incurred on their sale. Realized and unrealized gains and
losses arising from changes in the fair value of these assets are recognized in the income statement as income from cash and cash equivalents.
Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. Their classification in each of these categories depends on the business model applied to them and the characteristics of their contractual cash flows (the "solely payments of principal and interest - SPPI" or "basic loan" criteria). Accordingly, after initial recognition, loans and receivables are measured at amortized cost using the effective interest rate method, less any impairment.
This item includes deposits and guarantees in the case of non-current assets, and trade receivables (trade and other current assets) in the case of current assets.
Trade receivables are initially recorded at their fair value, which is equal to their nominal value for short-term receivables. They are discounted when their maturity date is greater than one year. They are then recognized at amortized cost and the interest is recorded as financial income in the income statement.
These assets may be subject to impairment in the event of an expected credit loss.
In the case of trade receivables, risk analysis is performed on a case-by-case basis, taking into account criteria such as the financial situation of the client (likelihood of bankruptcy or significant financial difficulties), the age of the receivable or the existence of a dispute.
Stocks are valued at the lower of cost and net realizable value. Cost is determined using the weighted average cost method. The cost of finished goods and work in progress includes raw material costs, direct costs and production overhead.
Depreciation is determined by comparing the inventory value with the acquisition cost.
Equity instruments (such as stock options, bonus shares and warrants) granted by the Company are measured at the grant date in accordance with IFRS 2, with the result that an expense is recognized in the income statement. The valuation is performed using the Black & Scholes and binomial/trinomial methods by an external service provider. The implementation of these methods requires, in particular, the use of assumptions on the price of the underlying Onxeo share as well as on its volatility. The expense is generally spread over the vesting period.
The vesting of stock options, warrants or free shares granted to Group employees is subject to a condition of presence at the date of acquisition. If an employee leaves before this date, the condition is no longer met and the employee loses the benefit of his or her rights. In this situation, the Group applies the "forfeiture" method, which consists of reversing in the income statement all expenses previously recognized for plans that have not been definitively acquired.
Pension obligations are recognized as provisions. In accordance with IAS 19, the actuarial valuation method used is the Projected Unit Credit Method with Service Prorate, which is based on financial assumptions (discount rate, inflation rate) and demographic assumptions (rate of salary increase, employee turnover rate).
This method allows for the determination of the present value of benefits based on services rendered by the employee at the measurement date. Actuarial gains and losses are recognized in "other comprehensive income".
Consolidated financial statements at December 31, 2021 prepared under IFRS

A provision is recognized when the Group has a present legal or constructive obligation to a third party as a result of a past event, which is likely to result in an outflow of resources to the third party without at least equivalent consideration being received from the third party, and the future cash outflow can be reliably estimated.
In accordance with IAS 20 on accounting for government grants and disclosure of government assistance, the benefits of loans with zero or low interest rates compared to market rates are taken into account and therefore recognized as grants. Repayable advances less the amount of the grant are recorded as financial liabilities. Interest expenses are calculated on the basis of market interest rates.
Repayable advances without a preferential rate are accounted for in accordance with IAS 39 under the "amortized cost" rule; financial expenses are calculated at the effective interest rate.
Repayable advances are recorded under "Other non-current financial liabilities" and "Short-term borrowings" depending on their maturity. They are measured at fair value on initial recognition, which in most cases is the nominal value, and then at amortized cost.
In the event of the failure of the financed program, which must be duly justified to the lender, the advances received are generally forfeited and the waiver of debt willingness is recorded as a subsidy on the line "Other operating income".
Bank loans and debt instruments are initially recorded at fair value less directly attributable transaction costs. Subsequent to initial recognition, they are measured at amortized cost using the effective interest method.
Gains and losses are recognized in the income statement when debts are derecognized, as well as through the amortized cost mechanism. The interest expense, as determined using the effective interest rate method (and including amortization of original costs), is recognized in "Financial income, Cost of debt".
Financial liabilities classified as short-term correspond to commitments of less than one year.
Other current liabilities at the balance sheet date consist exclusively of the debt to SpePharm and are measured at fair value.
Under IFRS 15, revenue is recognized when the Company fulfills a performance obligation by supplying separate goods or services (or a set of goods or services) to a client, i.e. when the client obtains control of those goods or services.
In view of the Group's activity, revenues generally include revenues from licensing agreements signed with commercial partners, royalties received on the sales of these partners, invoicing for services and revenues from sales of pharmaceutical products.
Each transaction or contract has been and will be analyzed, on a case-by-case basis, in order to determine the "performance obligations" towards the client, according to the principles of IFRS 15.
• Licensing Agreements
The Group develops drugs from the early stages to human clinical trials with the objective of obtaining sufficiently conclusive results to obtain the best value for these products through licensing agreements with commercial partners. In exchange for access to the technology of one or more products in its licensed portfolio, the Group generally receives an initial payment on signature of the contract, various additional payments on reaching key development milestones (start of a clinical study, submission of a marketing authorization application, obtaining this authorization, etc.) or contractual sales targets (annual or cumulative), as well as royalties corresponding to a percentage of net sales achieved by the partner.
The group's main contracts were analyzed as including:
Additional amounts paid by the client based on the achievement of contractual milestones or objectives, as well as royalties on revenues, are variable components of the contractual remuneration. They are recognized as revenue when it is highly probable that these objectives will be achieved.
• Product sales
Sales of products are recognized as revenue upon transfer of control to the customer at the time of delivery in an amount that reflects the payment the company expects to receive for the goods.
• Services
In the event that a license agreement includes separate services, the corresponding revenue (allocated to this performance obligation) is prorated over the estimated duration of the Group's involvement in future development studies, which may be subject to periodic review.
In accordance with IAS 20, government grants, the amounts of which are related to the rate of corresponding expenditure, are classified as a deduction from the corresponding expenses.
This item includes non-recurring, non-operational and significant events.
A deferred tax asset is recognized for the carry forward of unused tax losses and tax credits where it is probable that future taxable profits will be available against which the unused tax losses and tax credits can be utilized.
A deferred tax liability is recognized for all taxable temporary differences as well as for deferred tax on acquired R&D assets.
Research tax credits (CIR) are granted to companies by the French government to encourage them to carry out technical and scientific research. Companies that can prove that they have incurred expenses that meet the criteria required to benefit from the RTC can use it to pay corporate income tax for the year in which the expenses were incurred, as well as for the three following years. If the amount of tax is not sufficient to cover the full amount of the tax credit at the end of the three-year period, the difference is refunded by the government in cash to the entity. If the company meets certain criteria in terms of sales, headcount or assets to be eligible for the SME category, it can request an immediate refund of the RTC. Onxeo meets these criteria. Onxeo benefits from a similar mechanism in Denmark.
The Group uses RTCs for research expenses incurred during each fiscal year and records the amount receivable as a reduction of these expenses in the same year.

The Group's operational and financial activities expose it to the following main risks in relation to the financial instruments used.
Liquidity risk is essentially linked to the Group's financial profile as long as it does not generate significant revenues in relation to its expenditure, particularly on research and development. The level of cash at the end of the financial year as well as the financing commitments received from its main shareholders, Invus and Financière de la Montagne, give it financial visibility at least into Q2 2023 on the basis of its financing plan. Beyond this deadline, it is not excluded that the Group will have recourse to other non-dilutive financing or fundraising to secure its operations in the event that it does not manage to generate additional resources, in particular through new licensing agreements.
In addition, the Group has no structural borrowings. Financial liabilities are usually advances from public bodies (notably BPI France) in the context of R&D programs, which are only repayable in the event of proven technical and commercial success. However, at the beginning of 2021, the Group took out government-backed loans of up to 5 million euros as part of the aid measures put in place by the government to deal with the health crisis. The Group has chosen to repay these loans over a period of five years and to benefit from a one-year grace period on the repayment of the principal, the latter to be repaid as from March 2023.
The Group's trade receivables at the balance sheet date mainly comprise royalties on current and future sales of Beleodaq, under the licensing agreement with Acrotech Biopharma. This company, a subsidiary of the international pharmaceutical group Aurobindo, is not considered to generate a significant credit risk. The receivables from Biogen were collected at the beginning of 2022 and therefore present no credit risk.
Counterparty risk is limited to the investments made by the Group. These investments are made in leading institutions and the company monitors its exposure to financial counterparty risk on an ongoing basis.
The company conducts transactions in foreign currencies, however the net exposure to foreign exchange risk is limited. For this reason, no currency hedging instruments have been put in place.
Although the Group has contracted a bond issue, it is not subject to interest rate risk insofar as the bond redemption premium is fixed and independent of the interest rate markets.
Intangible fixed assets in the net amount of 20,531 thousand euros as of December 31, 2021 consisted primarily of R&D assets acquired in connection with the acquisition of DNA Therapeutics (AsiDNA™) and goodwill recognized on the occasion of the merger with Topotarget, as detailed below:

| In thousands of € | 12/31/2019 | Increase | Decrease | 12/31/2020 | Increase | Decrease | 12/31/2021 |
|---|---|---|---|---|---|---|---|
| Beleodaq® R&D assets | 68,700 | -68,700 | 0 | 0 | |||
| AsiDNA™ R&D assets | 2,472 | 2,472 | 2,472 | ||||
| Goodwill | 20,059 | 20,059 | 20,059 | ||||
| Other intangible assets | 420 | 83 | 503 | 4 | 507 | ||
| Total gross value | 91,651 | 83 | -68,700 | 23,034 | 4 | 23,038 | |
| Amortization of Beleodaq® R&D assets |
-6,313 | -57 | 6,370 | 0 | 0 | ||
| Other amortization | -419 | -81 | -500 | -7 | -507 | ||
| Total amortization | -6,732 | -138 | 6,370 | -500 | -7 | -507 | |
| Impairment of Beleodaq® R&D assets |
-59,561 | 59,561 | 0 | 0 | |||
| Goodwill impairment | -2,000 | -2,000 | -2,000 | ||||
| Total impairment losses | -61,561 | 59,561 | -2,000 | -2,000 | |||
| TOTAL | 23,358 | -55 | -2,769 | 20,534 | -3 | 20,531 |
The R&D assets, corresponding to AsiDNA™, being unamortized, as well as goodwill, were tested for impairment at December 31, 2021, as described below.
The value in use of these assets has been determined by using the projected cash flow method based on a 20 year financing plan prepared by management and representing its best estimate. This financing plan takes notably into account a model of future sales of products under development and includes probabilities of success. The valuation model does not include a terminal value, as all foreseeable cash flows are included within the time horizon chosen. A discount rate of 15.7% has been applied to the cash flows, integrating the market risk and the specific risks related to Onxeo. The value in use obtained for AsiDNA™ being greater than the basis tested, no impairment was recognized.
The Group has performed an impairment test of the goodwill. As the Group, as a whole, benefits from the synergies associated with the goodwill, the latter is tested for impairment at Group level. In accordance with IAS 36.6, the recoverable amount of a CGU is the higher of the fair value less costs of disposal and its value in use.
In a first step, the Group has determined its fair value. Since the market for Onxeo shares can be considered an active market within the meaning of IFRS 13.38.a, given the volumes of shares traded, which characterize significant liquidity, the fair value of the Group has been assessed by reference to its market capitalization at December 31, 2021. Costs of disposal were considered non-significant. At the end of the year, the market capitalization was higher than the basis tested (consolidated net book value at that date). Therefore, no impairment has been recorded.
In order to confirm this result, the Group has, in a second step, determined its value in use on the basis of a 20 year financing plan constructed by management and representing its best estimate. This financing plan takes notably into account a model of future sales of products under development and includes probabilities of success. The valuation model does not include a terminal value, as all foreseeable cash flows are included within the time horizon chosen. These cash flows include all revenues and expenses related to the indications currently in the portfolio, including potential developments on products developed by the Group. A discount rate of 15.7% has been applied to the cash flows, integrating the market risk and the specific risks related to Onxeo. The value in use thus determined is also higher than the basis tested (consolidated net book assets at December 31, 2020).

The group implemented a sensitivity test by varying the Onxeo share price and therefore the market capitalization used to assess the fair value of the Group. The table below presents the corresponding potential levels of goodwill impairment.
| En millions d'euros | Goodwill | |||||||
|---|---|---|---|---|---|---|---|---|
| Variation du cours de l'action | ||||||||
| -5% | 0 | |||||||
| -10% | 0 | |||||||
| -15% | 0 | |||||||
| -20% | -1.02 | |||||||
| -25% | -2.95 | |||||||
| -30% | -4.88 |
Regarding values in use, the Group has implemented sensitivity tests by varying the discount rate used for the model. The table below presents the corresponding potential levels of impairment of R&D assets related to AsiDNA®, as well as goodwill.
| En millions d'euros | AsiDNA® | Goodwill | |
|---|---|---|---|
| Variation du taux d'actualisation | |||
| +0,5% | 0 | 0 | |
| +1% | 0 | 0 | |
| +1,5% | -0.3 | 0 | |
| +2% | -1.8 | 0 | |
| +2,5% | -2.5 | -0.7 | |
| +3% | -2.5 | -3.6 |
Research and development costs incurred in fiscal year 2021 were expensed in the amount of 4,904 thousand euros, including 3,054 thousand euros for external expenses, 1,738 thousand euros for personnel expenses and 112 thousand euros for other expenses (regulatory taxes and depreciation).
| In thousands of € | 12/31/2019 | Increase | Decrease | 12/31/2020 | Increase | Decrease | 12/31/2021 |
|---|---|---|---|---|---|---|---|
| Gross value | 3,127 | 16 | 3,143 | 137 | 3,280 | ||
| Depreciations | -2,859 | -43 | -2,902 | -40 | -2,942 | ||
| Provisions for depreciation | -158 | -158 | -158 | ||||
| Net value of tangible fixed assets |
109 | -27 | 0 | 83 | 97 | 0 | 180 |
Tangible fixed assets consist mainly of various laboratory equipment and fixtures and fittings at our headquarters.
| In thousands of € | 12/31/2019 | Increase | Decrease | 12/31/2020 | Increase | Decrease | 12/31/2021 |
|---|---|---|---|---|---|---|---|
| Rights of use | 3,433 | 290 | -121 | 3,601 | 129 | -49 | 3,681 |
| Amortization of rights of use | -715 | -407 | -1,122 | -551 | 49 | 1,624 | |
| Net value of rights of use | 2,718 | -117 | -121 | 2,479 | -422 | 0 | 2,057 |
The rights of use correspond essentially to the lease of the headquarters and to the rental of laboratory equipment and vehicles. These rights of use will be amortized over the remaining term of the contracts.
| In thousands of € | 12/31/2019 | Increase | Decrease | 12/31/2020 | Increase | Decrease | 12/31/2021 |
|---|---|---|---|---|---|---|---|
| Deposits and guarantees | 127 | 4 | 123 | 2 | 125 | ||
| Liquidity contract - Cash | 14 | 96 | 110 | -73 | 37 | ||
| Net value of other financial fixed assets |
141 | 96 | 4 | 233 | 2 | -73 | 162 |
| In thousands of € | 12/31/2021 | < 1 year | > 1 year | 12/31/2020 |
|---|---|---|---|---|
| Trade receivables and related accounts | 8,526 | 8,526 | 6,654 |
Trade receivables consist mainly of receivables from the partner Acrotech Biopharma, which correspond to royalties to be received on sales of Beleodaq® in the United States until full repayment of the bond issue with SWK. This amount has been evaluated by management and amounts to 4,884 thousand euros as of December 31, 2021, all of which is classified as current (this amount includes 597 thousand euros of royalties for the fourth quarter of 2021).
The item also includes receivables from Biogen amounting to 3,640 thousand euros, corresponding to milestone payments and royalties on sales under a licensing agreement for a non-strategic product.
The breakdown of trade receivables by due date is as follows (in thousands of euros):
| Total | Amount due |
1 - 30 days | 31 - 60 days | 61 - 90 days | 91 - 120 days |
> 120 days | Amount not yet due |
|---|---|---|---|---|---|---|---|
| 8,526 | 8,526 |
No provision for impairment of trade receivables has been made in the absence of any identified credit risk.
| In thousands of € | 12/31/2021 | < 1 year | > 1 year | 12/31/2020 |
|---|---|---|---|---|
| Staff and related accounts | 14 | 14 | 11 | |
| Research tax credit | 1,745 | 1,745 | 1,124 | |
| Other tax receivables | 512 | 519 | 461 | |
| Prepaid expenses | 1,450 | 1,450 | 404 | |
| Net value of Other receivables | 3,721 | 3,728 | 2,000 |
The change in the item "research tax credit (RTC)" relates to the receipt of the receivable recognized at December 31, 2020 and the recognition of the RTC for 2021 for 1,745,000 euros, 1,718,000 euros for the French RTC and 27,000 euros for the Danish RTC. This receivable is recoverable in advance and has therefore been classified in full within one year.
In accordance with IAS 20, the research tax credit for fiscal year 2021 has been presented as a deduction from income and expense items according to its nature, as follows:
| In thousands of € | 12/31/2021 | 12/31/2020 |
|---|---|---|
| Decrease in personnel expenses | 429 | 445 |
| Decrease in external expenses | 1,273 | 643 |
| Decrease in depreciation and amortization | 43 | 36 |
| Total Research Tax Credit | 1,745 | 1,124 |
Other tax receivables correspond mainly to various VAT credits.
| In thousands of € | Net values as of 12/31/2021 |
Net values as of 12/31/2020 |
Change in cash and cash equivalents |
|---|---|---|---|
| Cash position | 5,584 | 6,523 | -937 |
| Cash equivalents | 12,302 | 8,000 | 4,302 |
| Total Net Cash and Cash Equivalents | 17,886 | 14,523 | 3,365 |
Cash equivalents include term accounts amounting to 12.3 million euros, in accordance with the provisions of IAS 7.6 and IAS 7.7, i.e. short-term, liquid and rapidly available investments.
The change in net cash is mainly related to the company's operating expenses, notably in research and development, for an amount of 13.5 million euros, offset by the receipt of 1.4 million euros in license revenues.
In terms of financing, the Group obtained government-backed loans of 5 million euros and implemented a capital increase for a net amount of 9.4 million euros. Finally, the group benefited from the reimbursement of its 2020 research tax credit for an amount of 1.1 million euros.
As of December 31, 2021, the capital amounted to 22 999 thousand euros, divided into 91,994,935 ordinary shares with a par value of €0.25 each, all of the same class and fully paid up.

During the year, the share capital changed as follows:
| Nominal | Nb Shares | € | ||
|---|---|---|---|---|
| Fully paid-up shares as of 12/31/2020 | 0.25 | 78,317,810 | 19,579,452.50 | |
| Capital increase | (1) | 0.25 | 13,677,125 | 3,419,281.25 |
| Fully paid-up shares as of 12/31/2021 | 0.25 | 91,994,935 | 22,998,733.75 |
(1) Capital increase with preferential subscription rights for shareholders on April 12, 2021, for a gross amount of 9,711,000 euros, through the issue of 13,677,125 new shares at a price of 0.71 euros each. The par value of each share is 0.25 euros, representing an increase in share capital of 3,419,000 euros and a share premium of 6,291,000 euros.
In accordance with IAS 32 §33, treasury shares acquired under the liquidity contract signed with Kepler-Cheuvreux have been deducted from equity in the amount of 181 thousand euros. The loss on the share buyback of 74,000 euros at December 31, 2021 has been cancelled from the income statement in accordance with the standard.
As a result of the capital increase described in 9.1 above, the share premium account increased by a total amount of 6,006,000 euros, after deducting the costs inherent in the operation.
The options and warrants were valued using the Black & Scholes method, supported by the binomial/trinomial method in order to account for the various possible exercise dates. This valuation was carried out with the help of an external service provider. The main assumptions used are the underlying share price, volatility and the average maturity of the instruments concerned.
During the year, the Board of Directors granted stock options to employees ("SO SAL 2021" plan) and to the Chief Executive Officer ("SO DIR 2020" plan), as well as a specific grant subject to the cancellation of options granted to the Group's current employees and to the Chief Executive Officer between 2011 and 2017 inclusive, the new quantities granted being equal to 50% of the quantities cancelled (SO 2021-2 plan). The Board of Directors has also granted stock warrants to a key consultant of the Company and to directors who are not officers or employees of the Company ("BSA 2021", "BSA 2021-2", "BSA 2021-3" and "BSA 2021-4" plans). These grants have the following characteristics:
| SO SAL 2021 | SO DIR 2021 | SO 2021-2 | |||||
|---|---|---|---|---|---|---|---|
| Date of grant | 7/29/2021 | ||||||
| Number of options granted | 278,000 | 429,194 | |||||
| Exercise price (€) | 0.62 | ||||||
| Vesting | Over 4 years, 25% per year Immediate |
| BSA 2021 | BSA 2021-2 | BSA 2021-3 | BSA 2021-4 | |
|---|---|---|---|---|
| Date of grant | 4/28/2021 | 6/11/2021 | 7/29/2021 | 10/06/2021 |
| Number of instruments granted | 150,000 | 100,000 | 300,000 | 150,000 |
| Number of warrants subscribed | 150,000 | 100,000 | 125,000 | 75,000 |
| Warrant subscription price (€) | 0.176 | 0.159 | 0.146 | 0.129 |
| Vesting | 100% on 10/28/2022 |
100% on 6/11/2022 |
By third party every 6 months |
By third party every 6 months |
| Exercise price (€) | 0.723 | 0.662 | 0.62 | 0.56 |

The 2021 expense relating to share-based payments amounts to 217 thousand euros, including 103 thousand euros in respect of instruments allotted in 2021.
The Board of Directors also noted the automatic cancellation of 6,022 SO 2018 options and 82,500 SO 2020 options due to the departure of employees in 2021. The impact of the cancellations is a decrease in the total expense of 31 thousand euros.

| Type | Date of authorization |
Authorized warrants |
Date of grant | Warrants granted |
BSA subscribed | Beneficiaries | Warrants outstanding as of 12/31/2021 adjusted (1) |
Warrants exercisable as of 12/31/2021 adjusted (1) |
Subscription price per share in euros adjusted (1) |
Expiration date |
|---|---|---|---|---|---|---|---|---|---|---|
| BSA 2013 | 06/26/2013 Resolution 17 |
100,000 | 9/19/2013 | 85,000 | 85,000 | Non-employee | 88,490 | 88,490 | 3.85 | 9/19/2023 |
| BSA 2014 | 06/30/2014 | 9/22/2014 | 107,500 | 82,500 | 85,886 | 85,886 | 6.17 | 9/22/2024 | ||
| BSA 2014-2 | Resolution 19 | 314,800 | 3/04/2015 | 35,500 | 19,000 | and non executive |
19,000 | 19,000 | 6.26 | 3/04/2025 |
| BSA 2015 | 05/20/2015 | 10/27/2015 | 80,000 | 65,000 | members of the Board of Directors |
65,000 | 65,000 | 3.61 | 10/27/2025 | |
| BSA 2015-2 | Resolution 18 | 405,000 | 1/23/2016 | 90,000 | 90,000 | 90,000 | 90,000 | 3.33 | 1/23/2026 | |
| BSA 2016 | 7/28/2016 | 260,000 | 190,000 | 160,000 | 160,000 | 3.16 | 7/28/2026 | |||
| BSA 2016-2 | 04/06/2016 405,520 Resolution 23 |
10/25/2016 | 30,000 | 30,000 | Key consultants of the company |
30,000 | 30,000 | 2.61 | 10/25/2026 | |
| BSA 2016-3 | 12/21/2016 | 70,000 | 70,000 | 52,500 | 52,500 | 2.43 | 12/21/2026 | |||
| BSA 2017 | 05/24/2017 Resolution 29 |
470,440 | 7/28/2017 | 340,000 | 300,000 | Non-employee and non |
300,000 | 300,000 | 4.00 | 7/28/2027 |
| BSA 2018 | 06/19/2018 | 7/27/2018 | 359,500 | 274,500 | executive members of the Board of Directors |
274,500 | 274,500 | 1.187 | 7/27/2028 | |
| BSA 2018-2 | Resolution 28 | 360,000 | 10/25/2018 | 85,000 | 85,000 | 85,000 | 85,000 | 1.017 | 10/25/2028 | |
| BSA 2020 | 9/17/2020 | 500,000 | 350,000 | 350,000 | 233,000 | 0.684 | 9/17/2030 | |||
| BSA 2021 | 06/19/2020 Resolution 31 |
500,000 | 4/28/2021 | 150,000 | 150,000 | Key consultants of the company(2) |
150,000 | 0 | 0.723 | 4/28/2031 |
(1) Adjustment of the number and subscription price of warrants following the capital increases of July 2011, July 2013 and December 2014, in accordance with Article L.228-99 of the French Commercial Code (Board of Directors' meetings of July 28, 2011, November 14, 2013 and January 22, 2015)
(2) Warrants granted to Ms. Shefali Agarwal under a consultancy agreement, prior to her appointment as a director (June 10, 2021)

| Type | Date of authorization |
Authorized warrants |
Date of grant | Warrants granted |
BSA subscribed | Beneficiaries | Warrants outstanding as of 12/31/2021 adjusted (1) |
Warrants exercisable as of 12/31/2021 adjusted (1) |
Subscription price per share in euros adjusted (1) |
Expiration date |
|---|---|---|---|---|---|---|---|---|---|---|
| BSA 2021-2 | 6/11/2021 | 100,000 | 100,000 | Non-employee and non |
100,000 | 0 | 0.662 | 6/11/2031 | ||
| BSA 2021-3 | 6/10/2021 700,000 Resolution 19 |
7/29/2021 | 300,000 | 125,000 | executive members of |
125,000 | 0 | 0.620 | 7/29/2031 | |
| BSA 2021-4 | 10/06/2021 | 150,000 | 75,000 | the Board of Directors |
75,000 | 0 | 0.560 | 10/06/2031 | ||
| TOTAL | 2,050, 376 | 1,483, 709 |
(1) Adjustment of the number and subscription price of warrants following the capital increases of July 2011, July 2013 and December 2014, in accordance with Article L.228-99 of the French Commercial Code (Board of Directors' meetings of July 28, 2011, November 14, 2013 and January 22, 2015)

| Plan Designation | Date of authorization |
Number of options authorized |
Date of grant | Number of options granted |
Beneficiaries | Outstanding options as of 12/31/2021 adjusted (1) |
Options exercisable as of 12/31/2021 adjusted (1) |
Subscription price per share in euros adjusted (1) |
Expiration date |
||
|---|---|---|---|---|---|---|---|---|---|---|---|
| SO Employees 2012 | 05/31/2012 | 333,000 | 268,000 | Employees | 52,321 | 52,321 | 3.75 | 9/13/2022 | |||
| SO Executives 2012 | Resolutions 13 and 14 |
110,000 | 9/13/2012 | 110,000 | Executives | 47,090 | 47,090 | 3.75 | 9/13/2022 | ||
| TOTAL SO 2012 | 443,000 | 378,000 | 99,411 | 99,411 | |||||||
| SO Employees 2013 | 06/26/2013 Resolution 15 |
283,000 | 9/19/2013 | 195,500 | Employees | 31,232 | 31,232 | 3.85 | 9/19/2023 | ||
| TOTAL SO 2013 | 283,000 | 195,500 | 31,232 | 31,232 | |||||||
| SO Employees 2014 | 06/30/2014 | 138,700 | Employees | 9,587 | 9,587 | 6.17 | 9/22/2024 | ||||
| SO Executives 2014 | Resolution 17 | 314,800 | 9/22/2014 | 40,000 | Executives | 15,616 | 15,616 | 6.17 | 9/22/2024 | ||
| TOTAL SO 2014 | 314,800 | 178,700 | 25,203 | 25,203 | |||||||
| SO Employees 2017 | 05/24/2017 | 7/28/2017 | 347,800 | Employees | 17,625 | 17,625 | 4.00 | 7/28/2027 | |||
| SO Employees 2017-2 | Resolution 26 | 470,440 | 3/29/2018 | 25,000 | Employees | 25,000 | 25,000 | 1.48 | 3/29/2028 | ||
| TOTAL SO 2017 | 470,440 | 417,800 | 42,625 | 42,625 | |||||||
| SO Employees 2018 | 06/19/2018 | 7/27/2018 | 758,604 | Employees | 416,805 | 361,791 | 1.187 | 7/27/2028 | |||
| SO Executives 2018 | Resolution 27 | 970,000 | 150,723 | Executives | 108,723 | 98,223 | 1.187 | 7/27/2028 | |||
| TOTAL SO 2018 | 314,800 | 178,700 | 525,528 | 460,014 | |||||||
| SO Employees 2020 | 06/19/2020 | 1,030,000 | Employees | 822,500 | 226,250 | 0.684 | 9/17/2030 | ||||
| SO Executives 2020 | Resolution 30 | 1,200, 000 | 9/17/2020 | 170,000 | Executives | 170,000 | 42,500 | 0.684 | 9/17/2030 | ||
| TOTAL SO 2020 | 314,800 | 1,200,000 | 992,500 | 268,750 | |||||||
| SO Employees 2021 | 9/17/2020 | 281,000 | Employees | 278,000 | 0 | 0.62 | 7/29/2021 | ||||
| SO Executives 2021 | 06/10/2021 Resolution 30 |
1,500, 000 | 12/16/2010 | 60,000 | Executives | 60,000 | 0 | 0.62 | 7/29/2021 | ||
| SO 2021-2 | 429,194 | Employees & executives | 429,194 | 429,194 | 0.62 | 7/28/2017 | |||||
| TOTAL SO 2021 | 1,500,000 | 770,194 | 767,194 | 429,194 | |||||||
| 2,483,693 | 1,356,429 |
( 1) Adjustment of the number and subscription price of warrants following the July 2011, July 2013 and December 2014 capital increases, in accordance with Article L.228-99 of the French Commercial Code (Board of Directors' meetings of July 28, 2011, November 14, 2013 and January 22, 2015).
| In thousands of € | 12/31/2020 | Allocations | Write-offs | 12/31/2021 | |
|---|---|---|---|---|---|
| used | non-used | ||||
| Pension obligations | 612 | -5 | 607 | ||
| Provisions | 1,028 | -127 | 901 | ||
| Total non-current provisions | 1,640 | -127 | -5 | 1,508 |
The provision for retirement obligations amounted to 607 thousand euros compared with 612 thousand euros in 2020. This decrease results in a 43,000 euro charge to income and a 49,000 euro actuarial gain or loss recorded in other comprehensive income, in accordance with the standard.
The actuarial assumptions used were as follows:
| 12/31/2021 | 12/31/2020 | ||||
|---|---|---|---|---|---|
| Collective agreement | National Agreement of Pharmaceutical Companies | ||||
| Retirement age | Between the ages of 65 and 67, in application of the law of November 10, 2010 on pension reform |
||||
| Calculation date | 12/31/2021 | 12/31/2020 | |||
| Mortality table: | INSEE 2021 | INSEE 2019 | |||
| Discount rate | 1.12% | 0.64% | |||
| Salary escalation rate | 2% | 2% | |||
| Turnover rate | By age structure: - 0 % between the ages of 16 and 24 - 0 % between the ages of 25 and 34 - 4.65 % between the ages of 35 and 44 - 1.16 % between the ages of 45 and 54 - 1.16 % over the age of 55 |
By age structure: - 0 % between the ages of 16 and 24 - 1.80 % between the ages of 25 and 34 - 8.11 % between the ages of 35 and 44 - 1.80 % between the ages of 45 and 54 - 0.00 % over the age of 55 |
|||
| Payroll tax rates | 46% for Onxeo FR |
Provisions consist of provisions for disputes amounting to 200 thousand euros and a provision for remediation in the context of the application of IFRS 16 amounting to 271 thousand euros.
They also include future development costs for belinostat that will be borne by Onxeo under the license agreement with Acrotech for an amount of 430,000 euros; this amount has been estimated by management on the basis of scenarios with a probability of occurrence and will be re-evaluated at each closing.
| Change | |||||
|---|---|---|---|---|---|
| In thousands of € | 12/31/2021 | 12/31/2020 | Total | Impact on cash flow |
No cash impact |
| State-Backed Loans | 5,000 | 5,000 | 5,000 | ||
| Bond debt | 0 | 2,350 | -2,350 | -2,350 | |
| Repayable advances | 83 | 148 | -65 | -65 | |
| Subtotal | 5,083 | 2,498 | 2,585 | 5,000 | -2,415 |
| Lease debts | 1,428 | 1,780 | -352 | -352 | |
| TOTAL | 6,511 | 4,278 | 2,233 | 5,000 | -2,767 |
The government-backed loans (PGE) granted in February 2021 by Bpifrance and the Group's commercial banks have an initial term of one year. These loans bear interest at rates between 0.25% and 1.75% over the initial term and these relatively low rates should lead to the recognition of a grant in accordance with IAS 20. However, given the purpose and terms of the PGEs, the value of the grant is linked to the term of the loan and the grant should be considered as a subsidy of the cost of financing the PGEs to be recognized in profit or loss on a symmetrical basis with the interest expense. The identification of a subsidy would therefore in practice have no impact on the result for the period, nor on its presentation in relation to the recognition of the PGEs at the contractual rate. For this reason, the Group has chosen to record them at the value of the cash received net of transaction costs. In addition, the Group has chosen to repay these loans over a period of 5 years starting in February 2022, the first year being a grace period during which only interest will be paid. As a result, the entire amount of the PGEs has been classified as non-current financial liabilities at December 31, 2021.
The debenture loan granted by SWK Holdings shall be reimbursed by royalties paid by the partner Acrotech Biopharma on sales of Beleodaq® in the United States. This debt had an initial amount of \$7.5 million (6.4 million euros) and a fixed redemption premium of \$6 million. The residual amount as of December 31, 2021 has been discounted using the original effective interest rate and has been reclassified in its entirety as short-term financial debt, as the Group considers it highly probable that this bond will be repaid in full in less than one year.
Repayable advances were granted by Bpifrance and the Ile de France region, notably as part of the Innov'Up Leader PIA program, to finance the Company's AsiDNA™ and PlatON™ R&D programs. These advances do not bear interest.
Rental debts are recognized in accordance with IFRS 16, with the offsetting entry in the accounts of the rights of use of the buildings and movable assets leased by the Group.
| In thousands of € | 12/31/2021 | From 1 to 5 years | More than 5 years |
|---|---|---|---|
| State-Backed Loans | 5,000 | 4,706 | 294 |
| Repayable advances | 83 | 83 | |
| Lease debts | 1,428 | 1,428 | |
| TOTAL | 6,511 | 6,217 | 294 |
The table below shows a breakdown by maturity of non-current liabilities:
Other non-current liabilities, amounting to 4,835 thousand euros, include the debt to SpePharm related to the settlement agreement signed by the Group on February 11, 2020 for an amount of 4,829 thousand euros. This debt will be repaid in the form of a 20% share of the amounts received under the license agreements entered into by Onxeo or its subsidiaries, and the residual amount at January 31, 2024 will be paid in full at that date.
| Change | |||||
|---|---|---|---|---|---|
| In thousands of € | 12/31/2021 | 12/31/2020 | Total | Impact on cash flow |
No cash impact |
| Accrued interest and commissions |
313 | 231 | 82 | -9 | 91 |
| Bond debt | 2,558 | 1,091 | 1,467 | -960 | 2,427 |
| Repayable advances | 82 | 180 | -98 | -163 | 65 |
| Subtotal | 2,953 | 1,502 | 1,451 | 1,132 | 2,583 |
| Lease debts | 471 | 477 | -6 | -487 | 481 |
| TOTAL | 3,424 | 1,979 | 1,445 | -1,619 | 3,064 |
No discounting has been applied insofar as trade payables are not older than one year.
| In thousands of € | 12/31/2021 | 12/31/2020 |
|---|---|---|
| Trade payables and related accounts | 2,832 | 2,762 |
The change in this item over the year is linked to the development of activities during the year, particularly in the area of R&D.
The Company conducts preclinical and clinical research and contracts with external partners who assist Onxeo in its studies. In the case of clinical trials, research expenses corresponding to services rendered and provisioned at the balance sheet date are determined based on management's estimates of costs that have not yet been invoiced per patient. These estimates are based on information provided by the contracted investigating centers (hospitals) and cost analyses performed by management.
| In thousands of € | 12/31/2021 | 12/31/2020 |
|---|---|---|
| Social security liabilities | 593 | 811 |
| Tax liabilities | 214 | 472 |
| Other liabilities | 0 | 23 |
| Total | 807 | 1,306 |
The change in social security liabilities is mainly due to the reduction in variable compensation for the year 2021.
The decrease in tax liabilities is due to the payment during the year of a tax for the year 2020 by the Danish establishment of Onxeo S.A., in the amount of 329 thousand euros.
The carrying amount of financial instruments by category under IFRS 9 is detailed as follows:
- As of 1/1/2021:
| Of which financial assets and liabilities | ||||||
|---|---|---|---|---|---|---|
| In thousands of € | Balance sheet value |
Of which non financial assets and liabilities |
Loans and receivables/lia bilities at amortized cost |
Financial assets/liabiliti es at fair value through profit or loss |
Lease debt | Total financial assets and liabilities |
| Other financial fixed assets | 233 | 123 | 110 | 233 | ||
| Trade receivables and related accounts |
6,654 | 6,654 | 6,654 | |||
| Other receivables | 2,000 | 2,000 | 2,000 | |||
| Cash and cash equivalents | 14,523 | 14,523 | 14,523 | |||
| Total Financial Assets | 23,410 | 23,300 | 110 | 23,410 | ||
| Other non-current financial liabilities |
4,278 | 2,498 | 1,780 | 4,278 | ||
| Other non-current liabilities | 5,089 | 5,089 | 5,089 | |||
| Short-term borrowings and financial liabilities |
1,979 | 1,502 | 477 | 1,979 | ||
| Trade payables and related accounts | 2,762 | 2,762 | 2,762 | |||
| Other liabilities | 1,306 | 1,306 | 1,306 | |||
| Total Financial Liabilities | 15,414 | 13,157 | 2,257 | 15,414 |
| Of which financial assets and liabilities | ||||||
|---|---|---|---|---|---|---|
| In thousands of € | Balance sheet value |
Of which non financial assets and liabilities |
Loans and receivables/lia bilities at amortized cost |
Financial assets/liabiliti es at fair value through profit or loss |
Lease debt | Total financial assets and liabilities |
| Other financial fixed assets | 162 | 125 | 37 | 162 | ||
| Trade receivables and related accounts |
8,526 | 8,526 | 8,526 | |||
| Other receivables | 3,721 | 3,721 | 3,721 | |||
| Cash and cash equivalents | 17,887 | 17,887 | 17,887 | |||
| Total Financial Assets | 30,295 | 30,258 | 37 | 30,295 | ||
| Other non-current financial liabilities |
6,510 | 5,083 | 1,428 | 6,510 | ||
| Other non-current liabilities | 4,835 | 4,835 | 4,835 | |||
| Short-term borrowings and financial liabilities |
3,424 | 2,953 | 471 | 3,424 | ||
| Trade payables and related accounts | 2,832 | 2,832 | 2,832 | |||
| Other current liabilities | 807 | 807 | 807 | |||
| Total Financial Liabilities | 18,409 | 16,510 | 1,899 | 18,409 |
Note: financial assets at fair value through profit or loss relate to cash held under the liquidity contract
Breakdown of financial assets and liabilities at fair value:
The table below presents the financial instruments at fair value broken down by level:
- Level 1: financial instruments listed on an active market
| Level 1 | Level 2 | Level 3 | |
|---|---|---|---|
| Financial assets at fair value through profit or loss | 37 | ||
| Total Financial Assets | 37 | ||
| Derivatives at fair value through profit or loss | |||
| Total Financial liabilities |
| In thousands of € | 12/31/2021 | 12/31/2020 |
|---|---|---|
| Recurring revenues from licensing agreements | 233 | 1,077 |
| Non-recurring revenues from licensing agreements | 3,829 | 699 |
| Total revenues | 4,062 | 1,776 |
Non-recurring revenues mainly comprise flat-rate royalties due from Biogen under a licensing agreement for a non-strategic product.
Recurring revenues correspond to royalties on sales received by the Group under the agreement with Biogen. The change from 2020 is related to the license agreement concluded in April 2020 for the product Beleodaq (belinostat). This agreement, which extended the marketing rights of the partner Acrotech Biopharma to the product in return for a one-time payment of \$6.6 million on signature, was considered as a disposal under IFRS insofar as it gave the partner control over the asset concerned and led to the recognition of all expenses and revenues relating to Beleodaq in fiscal 2020 (see note 11.4). This accounting treatment explains the absence of recurring revenue from Beleodaq in 2021, given that the amount of 1,077, 000 euros in 2020 corresponded to revenue from this product in the period prior to the signature of the agreement with Acrotech.
In accordance with IFRS 8.32 and 33, the table below shows the origin of revenues in terms of geographical area and in relation to the company's product categories:
| In thousands of € | 12/31/2021 | 12/31/2020 |
|---|---|---|
| Oncology products | 4,062 | 1,083 |
| Other Products (1) | 0 | 693 |
| Total | 4,062 | 1,776 |
| France | 0 | 302 |
| Others Europe | 0 | 143 |
| Rest of the world | 4,062 | 1,331 |
| Total | 4,062 | 1,776 |
(1) These products based on the Lauriad technology were either divested (Loramyc and Sitavig) or licensed worldwide (Validive) during 2017
The 2021 revenue comes exclusively from the United States.
Personnel expenses are broken down as follows:
| In thousands of € | 12/31/2021 | 12/31/2020 |
|---|---|---|
| Salaries | 3,017 | 3,358 |
| Charges | 1,172 | 1,273 |
| Employee benefits (IFRS 2) | 224 | 79 |
| Imputed Research Tax Credit | -429 | -445 |
| Total personnel expenses | 3,984 | 4,265 |
| Average headcount (employees and corporate officers) | 24 | 25 |
External expenses are composed of the following items:
| In thousands of € | 12/31/2021 | 12/31/2020 |
|---|---|---|
| R&D costs | 3,054 | 2,107 |
| Imputed Research Tax Credit | -1,273 | -643 |
| General and administrative expenses | 2,338 | 2,418 |
| Total | 4,119 | 3,882 |
The change in external expenses is mainly due to R&D activities, focused in 2021 on the clinical development of AsiDNA and on the optimization and preclinical development of OX400 family compounds.
The significant change in other non-recurring operating income and expenses is due to the recognition of the license agreement with Acrotech in 2020, which led to the recognition of the following amounts:
| In thousands of € | 12/31/2021 | Impact on cash flow |
No cash impact |
12/31/2020 |
|---|---|---|---|---|
| Income from cash and cash equivalents | 8 | 7 | 1 | 1 |
| Cost of financial debt | -848 | -767 | -81 | -959 |
| Cost of net financial debt | -840 | -760 | -80 | -958 |
| Other financial income | 513 | 513 | 1,006 | |
| Other financial expenses | -366 | -366 | -395 | |
| Financial income/loss | -693 | -760 | 67 | -347 |
The cost of net financial debt mainly includes the interest expense related to the bond issue with SWK Holdings Corporation.
The other financial income comes from the valuation at fair value of the bond loan with SWK (182 thousand euros), as well as the positive impact of the revaluation of the discounted amount of the future receivable from Acrotech, linked to Beleodaq (265 thousand euros). The other financial expenses correspond mainly to net exchange losses on the bond loan with SWK.
The tax income of 58 thousand euros recognized at December 31, 2021 corresponds to the following items:
At December 31, 2021, the Onxeo Group had French tax loss carryforwards of 304 million euros. No deferred tax asset has been recognized as the company is not in a position to recover this tax asset in the short term.
The reconciliation between tax expense and accounting income is presented below:
| In thousands of € | 12/31/2021 |
|---|---|
| Results of integrated companies | -5,937 |
| Reintegration of income taxes, amortization and provisions for goodwill and income from companies accounted for by the equity method |
100 |
| Income before income tax, goodwill amortization and provisions, and income from companies accounted for by the equity method |
-5,837 |
| Theoretical tax at the rate of the consolidating entity | 1,547 |
| Effects of base differences | -1,739 |
| Effects of rate differences | 883 |
| Effects of special tax provisions | 1,745 |
| Manual entries on Tax | -2,536 |
| Theoretical tax expense | -100 |
| Actual tax expense | -100 |
| Effective tax rate | N/A |
| In thousands of € | 12/31/2021 | 12/31/2020 |
|---|---|---|
| Net income attributable to common shareholders | -5,937 | 1,089 |
| Number of shares issued | 91,994,935 | 78,317,810 |
| Number of treasury shares | 429,850 | 272,438 |
| Number of shares outstanding (excluding treasury shares) | 91,565,085 | 78,045, 372 |
| Stock options | 2,483,693 | 2,735, 364 |
| Share subscription warrants | 2,050,376 | 1,600, 376 |
| Number of issued and potential shares (excluding treasury shares) | 96,099,154 | 82,381, 112 |
| Weighted average number of shares outstanding (excluding treasury shares) | 88,210,306 | 72,675, 204 |
| Net income per share in euros | -0.07 | 0.01 |
| Potentially dilutive securities resulting from the exercise of options and warrants | 3,444,722 | 2,698, 248 |
| Weighted average number of outstanding and potential shares (excluding treasury shares) |
91,655,028 | 75,373, 452 |
| Net diluted earnings per share in euros | -0.07 | 0.01 |
The impact of the dilution was not presented for 2021 as it is accretive due to a negative result.
None.
None.
The subsidiary Topotarget Switzerland holds patents licensed to and developed by third parties. These contracts provide for the payment of royalties linked to stages of product development.
The table below summarizes the compensation recorded as of December 31, 2021 for the Chief Executive Officer (non-employee corporate officer) and for the members of the Board of Directors (non-employee).
| In thousands of € | 12/31/2021 | 12/31/2020 |
|---|---|---|
| Short-term benefits (fixed/variable/exceptional) | 497 | 511 |
| Post-employment benefits | 172 | 187 |
| Long-term benefits | 0 | 0 |
| Share-based payments | 44 | 27 |
| Benefits in kind | 0 | 0 |
| Compensation for breach of employment contract | 0 | 0 |
| Remuneration allocated to directors (excluding CEO) | 196 | 133 |
| Fees (regulated agreement) | 56 | 0 |
| Total | 965 | 858 |
With reference to paragraph 9 of IAS 24, the parties related to Onxeo SA are
Transactions between the parent company and other Group companies are summarized in gross value in the following table:
| In thousands of € | 12/31/2021 | 12/31/2020 |
|---|---|---|
| Assets | 76,437 | 74,996 |
| Liabilities | 6,271 | 5,468 |
| Revenues | 43 | 9 |
| Charges | 899 | 1,229 |
The fees paid by the Company to Onxeo's auditors were as follows:
| Grant Thornton | Ernst & Young | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| In thousands of € | Amount | % | Amount | % | |||||
| 2021 | 2020 | 2021 | 2020 | 2021 | 2020 | 2021 | 2020 | ||
| Audit, statutory audit, certification, review of accounts under French and IFRS standards | |||||||||
| Issuer | 90 | 110 | 82% | 92% | 86 | 119 | 81% | 94% | |
| Fully consolidated subsidiary |
|||||||||
| Services other than certification of accounts |
20 | 9 | 18% | 8% | 20 | 8 | 19% | 6% | |
| Subtotal | 110 | 119 | 100% | 100% | 106 | 127 | 100% | 100% | |
| Other services provided by the networks to fully consolidated subsidiaries |
|||||||||
| Subtotal | |||||||||
| Total | 110 | 119 | 100% | 100% | 106 | 127 | 100% | 100% |
French member of Grant Thornton International 29, rue du Pont - CS 20070 92200 Neuilly-sur-Seine S.A.S. with a capital of € 2, 297,184 632 013 843 R.C.S. Nanterre
Statutory Auditor Member of the Versailles and Centre regional company
First Tower TSA 14444 92037 Paris-La Défense cedex S.A.S. with variable capital 344 366 315 R.C.S. Nanterre
Statutory Auditor Member of the Versailles and Centre regional company
This is a translation into English of the statutory auditors' report on the consolidated financial statements of the Company issued in French and it is provided solely for the convenience of English speaking users.
This statutory auditors' report includes information required by European regulation and French law, such as information about the appointment of the statutory auditors or verification of the information concerning the Group presented in the management report and other documents provided to shareholders.
This report should be read in conjunction with, and construed in accordance with, French law and professional auditing standards applicable in France
To the General Meeting of Shareholders of Onxeo,
In compliance with the engagement entrusted to us by your general meeting of shareholders, we have audited the accompanying consolidated financial statements of Onxeo for the year ended 31 December 2021.
In our opinion, the consolidated financial statements give a true and fair view of the assets and liabilities and of the financial position of the Group as at 31 December 2021 and of the results of its operations for the year then ended in accordance with International Financial Reporting Standards as adopted by the European Union.
We conducted our audit in accordance with professional standards applicable in France. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
Our responsibilities under those standards are further described in the Statutory Auditors' Responsibilities for the Audit of the Consolidated Financial Statements section of our report.
We conducted our audit engagement in compliance with independence requirements of the French Commercial Code (Code de commerce) and the French Code of Ethics for Statutory Auditors (Code de déontologie de la profession de commissaire aux comptes) for the period from 1 January 2021 to the date of our report.
Due to the global crisis related to the Covid-19 pandemic, the consolidated financial statements for this accounting period have been prepared and audited under special circumstances. Indeed, this crisis and the exceptional measures taken in the context of the health emergency have had numerous consequences for companies, particularly on their operations and their financing, and have led to greater uncertainties regarding their future prospects. Those measures, such as travel restrictions and remote working, have also had an impact on the companies' internal organization and the performance of the audits.
It is in this complex, evolving context that, in accordance with the requirements of Articles L. 823-9 and R. 823-7 of the French Commercial Code (Code de commerce) relating to the justification of our assessments, we inform you of the key audit matters relating to risks of material misstatement that, in our professional judgment, were of most significance in our audit of the consolidated financial statements of the current period.
These matters were addressed in the context of our audit of the consolidated financial statements as a whole and in forming our opinion thereon, and we do not provide a separate opinion on specific items of the consolidated financial statements.
With regard to the intangible assets relating to R&D and goodwill, as stated in Note 3.5 "Intangible assets" to the consolidated financial statements, the valuation used as a reference for the impairment tests corresponds to the recoverable value, which is the higher of the fair value net of disposal costs or the value in use. We examined the conditions for implementation of the impairment tests and the data used by the Group's Management. We verified that Note 5 "Intangible assets" provides appropriate information on this matter.
We have also performed, in accordance with professional standards applicable in France, the specific verifications required by the laws and regulations of the information relating to the Group given in the Board of Director's Group management report.
We have no matters to report as to their fair presentation and their consistency with the consolidated financial statements.
Management is responsible for the preparation and fair presentation of the consolidated financial statements in accordance with International Financial Reporting Standards as adopted by the European Union and for such internal control as Management determines is necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud or error.
In preparing the consolidated financial statements, Management is responsible for assessing the Company's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless it is expected to liquidate the Company or to cease operations.
The consolidated financial statements were approved by the Board of Directors.
Our role is to issue a report on the consolidated financial statements. Our objective is to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from material misstatement. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with professional standards will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these consolidated financial statements.
As specified in Article L. 823-10-1 of the French Commercial Code (Code de commerce), our statutory audit does not include assurance on the viability of the Company or the quality of management of the affairs of the Company.
As part of an audit conducted in accordance with professional standards applicable in France, the statutory auditor exercises professional judgment throughout the audit and furthermore:
► Obtains sufficient appropriate audit evidence regarding the financial information of the entities or business activities within the Group to express an opinion on the consolidated financial statements. The statutory auditor is responsible for the direction, supervision and performance of the audit of the consolidated financial statements and for the opinion expressed on these consolidated financial statements.
Neuilly-sur-Seine et Paris-La Défense, 28 April 2022
The Statutory Auditors
(French original signed by)
GRANT THORNTON French member of Grant Thornton International
ERNST & YOUNG Audit
Samuel Clochard Franck Sebag
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