Interim / Quarterly Report • Sep 30, 2020
Interim / Quarterly Report
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1 | HALF-YEAR FINANCIAL REPORT 2020 | Abivax
| 1 | LEADERSHIP |
3 | |||
|---|---|---|---|---|---|
| 2 | HALF-YEAR ACTIVITY REPORTS | 4 | |||
| 2.1 | ABIVAX – AN OVERVIEW4 |
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| 2.2 | DESCRIPTION OF THE HIGHLIGHTS AND ACTIVITIES OF ABIVAX IN THE FIRST HALF OF 2020 6 |
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| 2.3 | FINANCIAL SITUATION AND RESULTS: NOTES ON THE FIGURES9 |
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| 2.4 | PRINCIPAL RISK FACTORS 17 |
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| 3 | INTERIM FINANCIAL STATEMENTS AT 30 JUNE 2020 | 18 | |||
| 3.1 | INCOME STATEMENT 18 |
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| 3.2 | BALANCE SHEET 19 |
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| 3.3 | CASH FLOW STATEMENT 20 |
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| 3.4 | STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY SHARE21 |
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| 3.5 | NOTES TO THE FINANCIAL STATEMENTS22 | ||||
| 4 | DECLARATION BY THE PERSON RESPONSIBLE FOR THE INTERIM | ||||
| FINANCIAL REPORT 51 |
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| Chairman: | Dr Philippe Pouletty | |
|---|---|---|
| Directors: | Carol L. Brosgart | |
| Corinna zur Bonsen-Thomas | ||
| Jean-Jacques Bertrand | ||
| Joy Amundson | ||
| Sofinnova Partners, represented by Kinam Hong | ||
| Santé Holding SRL represented by Dr Antonino Ligresti | ||
| Truffle Capital represented by Christian Pierret | ||
| Management | ||
| Chief Executive Officer | Pr Hartmut Ehrlich |
|---|---|
| Chief Financial Officer and Secretary of the Board of Directors | Didier Blondel |
| Chief Commercial Officer and V.P. Business Development | Pierre Courteille |
| V.P. Process and Manufacturing Development | Jérôme Denis |
| V.P. Clinical Operations | Paul Gineste |
| V.P. Regulatory Affairs, Quality and Pharmacovigilance | Alexandra Pearce |
| Director of Communications | Regina Jehle |
| V.P. R&D | Didier Scherrer |
| Chief Medical Officer | Dr Jean-Marc Steens |
| V.P. Research | Jamal Tazi |
Abivax is an innovative biotech company that is mobilising the body's natural immune "machinery" to treat patients suffering from inflammatory diseases, infectious diseases and cancer. A clinical-stage biotechnology company, Abivax uses its three platforms to discover and optimise drug candidates, two of which are currently being tested in various clinical trials for the treatment of inflammatory bowel disease, rheumatoid arthritis, COVID-19, HIV and liver cancer. The anti-inflammatory and antiviral products and immunotherapies developed by Abivax come from three proprietary technology platforms:
Abivax conducts its R&D activities mainly in Montpellier and has its registered office in Paris. It has 27 employees at both locations. The Abivax management team has extensive experience in the development and marketing of biopharmaceutical products for inflammatory and infectious diseases and antivirals. The Company has a world-renowned Scientific Committee and a Board of Directors comprising members with solid experience gained at major pharmaceutical laboratories and international vaccine manufacturers.
Abivax is currently focusing its efforts on the following points:
The Company was incorporated as a société anonyme (public limited company) on 6 December 2013 and absorbed Splicos, Wittycell and Zophis in 2014 via a full transfer of the assets and liabilities of these companies. The Company is listed on Euronext Paris since 26 June 2015. Abivax is currently listed on Compartment C of Euronext Paris.
It does not have any subsidiaries and is thus not required to present consolidated financial statements under IFRS rules. Its annual financial statements are therefore prepared in accordance with French accounting standards and principles.
"Modulation of RNA Biogenesis" platform
Ulcerative colitis Phase 2a
Abivax organises a symposium at the 15th Congress of the European Crohn's and Colitis Organisation (ECCO) in Vienna - February 2020
On 13 February 2020, Abivax presented the new mechanism of action for ABX464, as well as clinical data from the Phase 2a induction study and its maintenance study. The ECCO congress is the most important world congress in the field of chronic inflammatory bowel diseases (IBD).
Abivax receives approval from US regulatory authorities (FDA) to launch clinical trials with ABX464 in the treatment of moderate to severe ulcerative colitis - January 2020
Abivax announced on 20 January 2020 that the Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for its flagship drug candidate ABX464, thus enabling the launch of clinical trials in the United States to treat patients with moderate to severe ulcerative colitis (UC).
The Company has obtained authorisation from the French regulatory authorities (ANSM) and the French Ethics Committee (CPP) to initiate a Phase 2b/3 clinical study with ABX464 to prevent severe inflammation leading to acute respiratory distress syndrome (ARDS) in 1,034 elderly or high-risk patients with COVID-19 (miR-AGE study). The trial carried out in 50 French and European hospitals will be a randomised, doubleblind, placebo-controlled trial. An interim analysis will be performed after the treatment of 300 patients and, subject to the evolution of the pandemic, Abivax envisages to complete recruitment in Q4 2020.
ABX464, as evaluated by RTqPCR, inhibits the in vitro viral replication of SARS-CoV-2 (COVID-19). Patients with COVID-19 die of acute respiratory failure due to viral replication inducing pulmonary hyperinflammation. ABX464 is thus the only drug with such a promising triple effect, inhibiting SARS CoV-2 replication, shown in vitro, reducing inflammation and contributing to tissue repair, as demonstrated in patients suffering from ulcerative colitis. ABX464 meets the U.S. NIH/NIAID's strategic priorities for new treatments addressing COVID-19: antiviral, anti-inflammatory, tissue repair, and simple once-daily oral administration.
Abivax treats a first patient in the Phase 2B/3 trial of ABX464 in COVID-19 – July 2020
A first patient was treated with ABX19, an iNKT (invariant natural killer T-cell) agonist, administered in combination with nivolumab. The Phase 1/2 clinical trial will evaluate the tolerance as well as the preliminary efficacy of this treatment combination. The study is carried out in collaboration with the Scripps MD Anderson Cancer Center in San Diego, California, and the MD Anderson Cancer Center in Houston, Texas.
In order to optimise its cash management, Abivax arranged for the pre-financing of its 2019 CIR with the Acofi Gestion management companies. The transaction was arranged by Neftys Conseil.
The company has decided to reduce by €500,000 the envelope allocated under the liquidity agreement with TSAF in April 2020, thereby optimising the amount necessary for efficient management of this activity.
Bpifrance is funding this ABX464-COVID-19 project with non-dilutive financing of €36 million (grant of €20.1 million grant and refundable advance of €15.9 million in case of project success) intended to finance the Phase 2b/3 trial of ABX464 on patients with COVID-19 and for the increase in production and additional costs related to the clinical programme and development of ABX464. This financing is explained in Note 10 - Conditional Advances and Grants.
The €5 million loan is structured as an SGL (State Guaranteed Loan) with an initial maturity of 12 months at 0.25% and a 5 year extension option. This loan provides additional non-dilutive financing to the €36 million non-dilutive financing granted by Bpifrance.
The health crisis caused by the COVID-19 pandemic and the promulgation of the state of emergency for health reasons by Act No. 2020-290 of 23 March 2020 constitute a major event.
However, Abivax is aware of the risks associated with the global outbreak of the COVID-19 coronavirus that could have a significant impact on the company's business. The extent to which the COVID-19 coronavirus is likely to have an effect on the Company's activity and clinical trials will depend on future developments, which can hardly be predicted with certainty. In addition, the short- and medium-term magnitude of the negative impact of this epidemic on financial markets, the stock price of the Company and its ability to finance itself is currently unknown. Given the above, it is currently difficult for the Company to provide a comprehensive and realistic assessment of the risks associated with the COVID-19 coronavirus pandemic. Given the nature of the company's activity in the health sector, the importance of which is confirmed by the current pandemic, Abivax considers that business continuity has not been affected by COVID-19.
The results of the Phase 2a open-label maintenance study after two years of treatment confirm the good safety and long-lasting efficacy of 50 mg of ABX464 administered orally daily. After two years of treatment, 69% of patients have reached the stage of clinical remission and 94 benefit from a clinical response. At the same time, admission of patients in the Phase 2b study in ulcerative colitis continues as planned with 69% (159/232) of patients randomised to date. Recruiting is expected to end in late 2020 with results expected in the second quarter of 2021.
The financial statements of Abivax at 30 June 2020 mainly reflect:
The following tables summarise the key items from the half-yearly results drawn up according to French accounting standards, for the first half of 2020 and 2019 and certain items as at 31 December 2019.
| Income statement items | H1 2020 | H1 2019 | Change |
|---|---|---|---|
| in thousands of euros | |||
| Total operating income | 1,633 | 40 | 1,592 |
| Total operating expenses | -16,258 | -17,268 | 1,010 |
| of which Research and Development costs | -13,468 | -14,981 | 1,513 |
| of which administrative costs and overheads | -2,790 | -2,288 | -502 |
| Operating income | -14,625 | -17,228 | 2,602 |
| Net Financial Income | -963 | -655 | -308 |
| Income from continuing operations | -15,588 | -17,883 | 2,295 |
| Extraordinary income | 166 | -47 | 213 |
| Income tax | 0 | -3,759 | 3,759 |
| Income for the period | -15,422 | -14,172 | -1,250 |
| ASSETS - in thousands of euros | 30/06/2019 | 31/12/2019 | Change |
| Fixed assets | |||
| Intangible assets | 32,095 | 32,090 | 5 |
| Property, plant and equipment | 104 | 134 | -30 |
| Financial assets | 925 | 1,259 | -334 |
| Total Fixed assets | 33,123 | 33,483 | -360 |
| Current assets | |||
| Receivables | 4,281 | 8,131 | -3,850 |
| Marketable securities | 6 | 6 | 0 |
| Cash and cash equivalents | 12,050 | 9,765 | 2,285 |
| Prepaid expenses | 351 | 342 | 9 |
| Total Current assets | 16,687 | 18,244 | -1,557 |
| Total Assets | 49,811 | 51,728 | -1,917 |
| LIABILITIES | |||
| Shareholders' equity | -3,592 | 11,775 | -15,367 |
| Conditional advances | 13,196 | 6,816 | 6,380 |
| Provisions for risks and | |||
| contingencies | 0 | 0 | |
| Total Other capital | 9,604 | 18,591 | -8,987 |
| Payables | |||
| Convertible bonds | 4,000 | 4,000 | |
| Non-convertible bonds | 15,480 | 16,743 | -1,263 |
| SGL Loans | 5,000 | 5,000 | |
| Trade payables and related accounts | 13,508 | 10,545 | 2,963 |
| Accrued taxes and personnel | |||
| expenses | 2,188 | 1,843 | 345 |
| Other payables | 30 | 30 | |
| Total Payables | 40,207 | 33,132 | 7,075 |
| Currency translation losses | 5 | -5 | |
| Total liabilities | 49,811 | 51,729 | -1,918 |
10 | HALF-YEAR FINANCIAL REPORT 2020 | Abivax
Operating income
| Income Statement Items | Change | ||
|---|---|---|---|
| in thousands of euros | H1 2020 | H1 2019 | |
| Sales of goods | |||
| Production sold | |||
| Operating grants | 1,587 | -21 | 1,608 |
| Other income | 46 | 61 | -15 |
| Total operating income | 1,633 | 40 | 1,593 |
Given the early stage of its projects, the Company did not generate any revenue for the year.
The grants that appear in the income statement depend on project progress. Abivax receives grants from Bpifrance, the French public investment bank for the COVID-19, CARENA and RNP-VIR projects. During the first half of 2020, Abivax received €1,587,000 in grants corresponding to the initial key stage of the COVID-19 project. During the first half of 2019, the amount corresponding to the completion of milestone 2 of the RNP-VIR project, booked in 2018, was adjusted, resulting in an adjustment of €21,000. As such, Abivax received €290,000 from Bpifrance for key stage 2 of the RNP-VIR project, rather than the €311,000 initially recognised.
In H1 2020, operating income amounted to €46,000 compared to €61,000 in 2019. These correspond to transfers of miscellaneous operating expenses.
| Income Statement Items | ||||
|---|---|---|---|---|
| in thousands of euros | H1 2020 | H1 2019 | Change | |
| Purchases of raw materials | 1 | 16 | -15 | |
| External studies | 10,063 | 11,927 | -1,864 | |
| General subcontracting | 288 | 170 | 118 | |
| Supplies | 55 | 42 | 13 | |
| Rents, maintenance and upkeep costs | 249 | 237 | 11 | |
| Miscellaneous expenses | 191 | 208 | -17 | |
| Documentation, technological intelligence and seminars |
31 | 21 | 9 | |
| Patents | 482 | 487 | -5 | |
| Professional fees | 1,695 | 1,338 | 357 | |
| Work assignments and travel | 106 | 177 | -71 | |
| Other purchases and external expenses | 13,158 | 14,607 | -1,449 | |
| Taxes and similar levies | 55 | 67 | -12 | |
| Wages and salaries | 2,165 | 1,776 | 389 | |
| Social security contributions | 800 | 728 | 72 | |
| Depreciation expense | 33 | 45 | -12 | |
| Other expenses | 45 | 29 | 16 | |
| Total operating expenses | 16,258 | 17,268 | -1,010 |
As at 30 June 2020, operating expenses were €16,258,000. 81% of the operating expenses were made up of "other purchases and external expenses", with more than 76% of these relating to external studies and scientific sub-contracting (clinical trials, laboratory research studies, toxicology, and industrial process development).
Costs associated with external studies and sub-contracting in the first half of 2020 are mainly linked to the following events:
Costs associated with external studies and sub-contracting in the first half of 2019 were mainly linked to the following events:
| Income Statement Items in thousands of euros |
H1 2020 | H1 2019 | Change | |
|---|---|---|---|---|
| Financial income | 0 | 5 | -6 | |
| Financial expenses | 963 | 661 | 302 | |
| Net financial income | -963 | -655 | -307 |
In the first quarter of 2020, the financial expenses mainly consisted of interests on the Kreos borrowing (-€927,000) and the interests incurred to be paid in the context of the CARENA and RNP-VIR projects (-€36,000). No financial income was recognised in the first half of 2020.
| Income Statement Items in thousands of euros |
H1 2020 | H1 2019 | Change |
|---|---|---|---|
| Income from continuing operations before tax | -15,588 | -17,883 | 2,295 |
| Extraordinary income | 166 | -47 | 213 |
| Income tax (CIR) | 0 | 3,759 | -3,759 |
| Loss | -15,422 | -14,172 | -1,250 |
Exceptional income for the first half of 2020 was €166,000, consisting mainly of capital gains on the sale of treasury shares (€167,000).
Extraordinary result in the first half of 2019 was a loss of -€47,000, comprised of extraordinary losses of -€59,000 corresponding to the capital losses realised on treasury share sales (-€13,000) and impairment of treasury shares due to the stock market price at 30 June 2019 (-€46,000), an adjustment of the provision linked to the tax audit (-€49,000) as well as €61,000 linked to capital gains realised during the sale of treasury shares. In July 2019, Abivax received final notice from the general management of the public finance authority with regard to the tax audit. This led Abivax to make an immaterial adjustment to the amount of the expected corrections.
Taking into account the repayable advances and subsidies received as part of COVID-19 financing (€7,934,000), no CIR was recorded in the first half of 2020. The Research Tax Credit (CIR) for the first half of 2019 was estimated to be €3,759,000 million. The amount of the tax credit is calculated on the eligible expenditure for the half-year, less any subsidies and repayable advances acquired.
The operating loss was -€15,422,000 (compared to -€14,172,000 at 30 June 2019, reflecting continued activity on the ABX464 on the various studies.
During the second half of the 2014 financial year, three full transfers of assets and liabilities were completed: Wittycell and Zophis were absorbed on 31 July 2014 and Splicos was absorbed on 31 October 2014. These three transactions resulted in the recording of technical losses, which replaced contributed equity under Assets in the amount of €32,745,000. These technical losses represent the differences between the net assets received as measured at the effective accounting date and the book value of the holdings at Abivax for each of the companies absorbed. These are technical losses and not financial losses, since they account for the value of the research and development costs incurred by these three predecessor companies that was recognised by Abivax upon acquisition of the holdings, plus that of the research and development programmes undertaken in early 2014. These research and development costs were not capitalised by the three dissolved companies, but instead were expensed as incurred. Technical losses were maintained in the absence of any indication of impairment over the period.
Financial assets correspond primarily to items relating to the liquidity agreement signed by the Company at the end of June 2015 and to security deposits paid for the premises occupied by the Company and in as part of the bond loan taken from Kreos in July 2018 and June 2019.
The liquidity agreement was signed on 26 June 2015 for a period of 12 months and renews automatically. A sum of €1 million was paid to the provider when the agreement was signed and the first transactions to build up a reserve of shares were carried out between 26 and 29 June 2015. The company requested a cash refund of €500,000 in April 2020.
At 30 June 2020, the company held 17,100 treasury shares via this liquidity agreement, i.e. less than 10% of its capital, for an acquisition cost of €302,000. The balance of the cash account with the service provider is €92,000.
| In thousands of euros | Quantity | Average price in euros* |
Book value of shares held |
Other financial assets |
|---|---|---|---|---|
| Balance at 31 December 2018 | 23,970 | 8 | 180 | 426 |
| Purchases | 30,729 | 9.46 | 291 | -291 |
| Sales | 27,299 | 9.72 | 265 | 265 |
| Realised capital gains or losses | 48 | |||
| Balance at 30 June 2019 | 27,400 | 9 | 254 | 401 |
| Purchases | 57,569 | 9.92 | 571 | -571 |
| Sales | 60,609 | 10.66 | 646 | 646 |
| Realised capital gains or losses | 122 | |||
| Balance at 31 December 2019 | 20,930 | 11 | 227 | 501 |
| Purchases | 18,977 | 17.86 | 339 | -339 |
| Sales | 22,807 | 18.87 | 430 | 430 |
| Realised capital gains or losses | 166 | |||
| Balance at 30 June 2020 | 17,100 | 18 | 302 | 92 |
The transactions related to the liquidity agreement are listed in the table below:
*average values for 2020, for example, €18 = €302,000/17,100 shares
The share price at 30 June 2020 was €20.8. The market value at 30 June 2020 of the treasury shares was therefore €356,000.
Receivables on fixed assets correspond to the amount available under the liquidity agreement entered into by the Abivax and deposits and guarantees paid by the Company.
Other receivables are mainly made up of:
| in thousands of euros | Amount |
|---|---|
| 2014 CIR balance receivable (including deferred payment interest) |
64 |
| 2019 CIR balance receivable (including deferred payment interest) |
363 |
| VAT | 2,439 |
| Trade receivables-CIFRE revenue | 7 |
| Reimbursement premium - Kreos | 1,183 |
| Loan issue costs - Kreos | 208 |
| Other receivables | 17 |
| Prepaid expenses | 351 |
| Total | 4,632 |
Marketable securities break down as follows:
| in thousands of euros | 30/06/2020 | Immediate availability |
|
|---|---|---|---|
| Term deposits | |||
| SICAV/UCITS | 6 | 6 | |
| Cash and cash equivalents | 12,050 | 12,050 | |
| Total | 12,056 | 12,056 |
The exercise of 1,300 BCE-2016-1 warrants on 7 January 2020, resulting in the issuance of 1,300 Company shares, resulted in an increase in the share capital of €13.00, raising the share capital from €122,019.59 to €122,032.59.
The exercise of 164 BSA-2014-3 warrants on 11 January 2020, resulting in the issuance of 16,400 Company shares, resulted in an increase in the share capital of €164.00, raising the share capital from €122,032.59 to €122,196.59.
The exercise of 3,000 BCE-2016-1 warrants on 16 January 2020, resulting in the issuance of 3,000 Company shares, resulted an increase in the share capital of €30.00, raising the share capital from €122,196.59 to €122,226.59.
The exercise of 10 BCE-2018-1 on 17 January 2020, resulting in the issuance of 10 Company shares, shares, resulted an increase in the share capital of €0.10, raising the share capital from €122,226.59 to €122,226.69. The exercise of 1,400 BCE-2016-1 warrants on 22 January 2020, resulting in the creation of 1,400 Company shares, resulted an increase in the share capital of 14.00, raising the share capital from €122,226.69 to €122,240.69.
The exercise of 1,600 BCE-2016-1 warrants on 11 February 2020, resulting in the issuance of 1,600 Company
shares, resulted an increase in the share capital of €16.00, raising the share capital from €122,240.69 to €122,256.69.
The Board of Directors has recognised all these capital increases.
The exercise of 26 BSA-2014-7 warrants on 17 March 2020, resulting in the issuance of 2,600 Company shares, resulted an increase in the share capital of €26.00, raising the share capital it from €122,256.69 to €122,282.69. The Board of Directors has not yet recognised this capital increase.
Note 6 of the Notes to the interim financial statements provides further details on shareholders' equity and the dilutive financial instruments currently in force.
The variation between 31 December 2019 and 30 June 2020 can be summarised as follows:
| in thousands of euros |
Balance at 31/12/2020 |
Interest accrued over the period |
Advances received over the period |
Advances repaid over the period |
Balance at 30/06/2020 |
Including conditional advances |
Including accrued interest |
|---|---|---|---|---|---|---|---|
| BPI CARENA | 2,361 | 15 | 2,377 | 2,187 | 190 | ||
| BPI EBOLA | 373 | 3 | 370 | 370 | |||
| BPI RNP-VIR | 4,081 | 21 | 4,102 | 4,032 | 70 | ||
| BPI COVID-19 | 6,348 | 6,348 | 6,348 | ||||
| Total | 6,815 | 36 | 6,348 | 3 | 13,197 | 12,937 | 260 |
At 30/06/2020, borrowings and financial debt include the Kreos loan with a convertible bond loan (€4,000,000), a non-convertible bond loan (€13,680,000) and a repayment premium (€1,800,000).
On the occasion of its introduction on Euronext – Compartment B, in June 2015, Abivax had set out the risk factors likely to affect it in the Background Document, available on its website. More recently, the said risk factors were updated in the 2020 Universal Registration Document, published on 25 May 2020. This document is available on the Company's website at www.Abivax.com.
The Company reiterates, as indicated in the Universal Registration Document mentioned above, that its activities are essentially based on biotechnology Research and Development operations, aimed at discovering, developing and marketing novel antiviral drugs and immunotherapy products for the treatment of potentially fatal infectious diseases.
The future of the Company depends on the success of clinical development and, where appropriate, on the transfer or concession to an industrial third party of the development and/or marketing rights for one of its products.
| Income Statement Items | Change | |||
|---|---|---|---|---|
| in thousands of euros | H1 2020 | H1 2019 | ||
| Operating income | 1,633 | 40 | 1,592 | |
| Production sold | 0 | |||
| Operating grants | 1,587 | -21 | 1,608 | |
| Other income | 46 | 61 | -16 | |
| Operating expenses | 16,258 | 17,268 | -1,010 | |
| Purchases of raw materials and supplies | 1 | 16 | -15 | |
| Other purchases and external expenses | 13,158 | 14,607 | -1,449 | |
| Taxes and duties | 55 | 67 | -12 | |
| Salaries and social security contributions | 2,966 | 2,504 | 461 | |
| Amortisation, depreciation and provisions | 33 | 45 | -12 | |
| Other expenses | 45 | 29 | 16 | |
| Operating income | -14,625 | -17,228 | 2,603 | |
| Financial income | 0 | 5 | -6 | |
| Financial expenses | 963 | 661 | 302 | |
| Net financial income | -963 | -655 | -307 | |
| Income from continuing operations | -15,588 | -17,883 | 2,295 | |
| Extraordinary income | 166 | -47 | 213 | |
| Income tax (CIR) | 0 | 3,759 | -3,759 | |
| Income for the period | -15,422 | -14,172 | -1,250 |
| in thousands of euros | 30/06/2020 | 31/12/2019 | Change |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible assets | |||
| Concessions, patents, licences, software | 32,094 | 32,090 | 4 |
| Property, plant and equipment | |||
| Technical facilities, industrial tools and equipment | 83 | 103 | -20 |
| Other property, plant and equipment | 21 | 31 | -10 |
| Financial assets | |||
| Other financial assets | 925 | 1,259 | -334 |
| Total Fixed assets | 33,123 | 33,483 | -359 |
| Current assets | |||
| Receivables | 4,281 | 8,131 | -3,850 |
| Cash instruments | |||
| Marketable securities | 6 | 6 | 0 |
| Cash and cash equivalents | 12,050 | 9,765 | 2,285 |
| Prepaid expenses | 351 | 342 | 9 |
| Total Current assets | 16,687 | 18,244 | -1,557 |
| Total Assets | 49,811 | 51,728 | -1,917 |
| LIABILITIES | |||
| Shareholders' equity | |||
| Capital | 122 | 122 | 0 |
| Issue, merger, transfer premiums | 11,708 | 104,686 | -92,978 |
| Retained earnings | 0 | -62,398 | 62,398 |
| Income for the financial year (profit or loss) | -15,422 | -30,634 | 15,212 |
| Total Other capital | -3,592 | 11,775 | -15,367 |
| Other equity | |||
| Conditional advances | 13,196 | 6,816 | 6,380 |
| Total Other capital | 9,604 | 18,591 | -8,987 |
| Provisions | |||
| Provisions for risks and contingencies | 0 | 0 | |
| Payables | |||
| Convertible bonds | 4,000 | 4,000 | 0 |
| Non-convertible bonds | 15,480 | 16,743 | -1,263 |
| Borrowings and financial debt – Other | 5,000 | 5,000 | |
| Trade payables and related accounts | 13,508 | 10,545 | 2,963 |
| Accrued taxes and personnel expenses | 2,188 | 1,843 | 345 |
| Other payables | 30 | 30 | |
| Total Payables | 40,207 | 33,132 | 7,075 |
| Currency translation losses | 5 | -5 | |
| Total liabilities | 49,811 | 51,723 | -1,912 |
| in thousands of euros | H1 2020 | H1 2019 | Change |
|---|---|---|---|
| Cash flows linked to operations | |||
| Operating income | -14,625 | -17,228 | 2,603 |
| + Amortisation, depreciation and provisions | 33 | 43 | -10 |
| - Change in operating receivables | -4 | -66 | 62 |
| + Change in trade payables | 2,963 | 3,501 | -538 |
| = Net operating cash flow | -11,633 | -13,750 | 2,116 |
| - Financial expenses | -687 | -483 | -204 |
| + Financial income | 0 | 5 | -5 |
| - Extraordinary expenses linked to activity | |||
| + Extraordinary income linked to activity | |||
| - Change in other receivables linked to activity | 3,604 | 2,847 | 757 |
| + Change in other payables linked to activity | 372 | -142 | 514 |
| = Net cash flow generated by activity (A) | -8,344 | -11,523 | 3,178 |
| Cash flow linked to investment | |||
| - Acquisitions of fixed assets | -346 | -568 | 222 |
| + Disposals of fixed assets | 430 | 265 | 165 |
| + Reduction of financial assets | 0 | 0 | |
| +/- Change in other payables and receivables | 409 | 25 | 384 |
| = Net cash flow linked to investment (B) | 493 | -277 | 770 |
| Cash flow linked to financing | |||
| + Capital increase in cash and payments made by partners | 55 | 404 | -350 |
| + Loans and borrowings issued and repayable advances received | 11,348 | 10,000 | 1,348 |
| - Repayment of loans and borrowing and repayable advances | -1,266 | -1,266 | |
| +/- Change in trade payables and receivables related to financing activities |
-50 | 50 | |
| = Net cash flow linked to financing (C) | 10,136 | 10,354 | -218 |
| Change in cash position (A+B+C) | 2,285 | -1,446 | 3,731 |
| + Cash at the beginning of the period | 9,771 | 13,002 | -3,231 |
| = Cash at the end of the period* | 12,056 | 11,556 | 500 |
* The amounts listed under Cash correspond to the Marketable securities and Cash and cash equivalents shown on the Balance Sheet
| Number of shares issued |
Capital | Premiums | BCEs/ BSAs |
Retained earnings |
Total | |
|---|---|---|---|---|---|---|
| At 31 December 2018 | 10,199,189 | 102 | 90,758 | 283 | -62,398 | 28,744 |
| Share offering – BoD Meeting 9 July 2019 | 1,500 000 | 15 | 11,985 | 12,000 | ||
| Exercise of founder warrants/stock subscription warrants |
294,770 | 3 | 3 | |||
| Kepler Cheuvreux equity line | 208,000 | 2 | 1,776 | 1,778 | ||
| Issue costs | -116 | -116 | ||||
| Stock subscription warrants issued | 1 | 1 | ||||
| 2019 loss | -30,636 | -30,636 | ||||
| At 31 December 2019 | 12,201 959 | 122 | 104,403 | 283 | -93,032 | 11,776 |
| Exercise of founder warrants/stock subscription warrants |
26,310 | 0 | 54 | 55 | ||
| Kepler Cheuvreux equity line | ||||||
| Stock subscription warrants issued | 0 | 0 | ||||
| Allocation to retained earnings on issue premium |
-93,033 | 93,033 | 0 | |||
| Loss at 06/2020 | -15,422 | -15,422 | ||||
| At 30 June 2020 | 12,228 269 | 122 | 11,425 | 283 | -15,422 | -3,592 |
Notes to the balance sheet before appropriation of total earnings of €49,811,000 at 30 June 2020 and to the income statement, presented in list form, generating a loss of -€15,422,000.
The interim financial statements cover a six-month period from 1 January 2020 to 30 June 2020.
The notes and statements below are integral to the financial statements on 30 June 2020 as agreed by the Board of Directors on 22 September 2020. Unless otherwise indicated, the figures provided are expressed in thousands of euros.
References to the first half of 2019 and to full year 2019 enable a more meaningful comparison of changes in the data concerned to assist in understanding the company's interim income statement at 30 June 2020.
Abivax is an innovative biotech company that is mobilising the body's natural immune "machinery" to treat patients suffering from inflammatory diseases, infectious diseases and cancer. A clinical biotechnology company, Abivax uses its three platforms to discover and optimise drug candidates, two of which are currently being tested in various clinical trials for the treatment of inflammatory bowel disease, rheumatoid arthritis, COVID-19, HIV and liver cancer.
The anti-inflammatory and antiviral products and immunotherapies developed by Abivax come from three proprietary technology platforms:
inhibitors. Given that immuno-oncology is not one of its core sectors, Abivax wishes to sign a licence agreement for this highpotential drug candidate once the proof-ofconcept study in progress has been completed.
Abivax conducts its R&D activities mainly in Montpellier and has its registered office in Paris. It has 27 employees at both locations. The Abivax management team has extensive experience in the development and marketing of biopharmaceutical products for inflammatory and infectious diseases and antivirals. The Company has a world-renowned Scientific Committee and a Board of Directors comprising members with solid experience gained at major pharmaceutical laboratories and international vaccine manufacturers.
Abivax is currently focusing its efforts on the following points:
The Company was incorporated as a Société Anonyme (French limited company) on 6 December 2013 and, in 2014, it acquired Splicos, Wittycell and Zophis by means of a universal transfer of assets and liabilities. The Company is listed on Euronext Paris since 26 June 2015. Abivax is currently listed on Compartment C of Euronext Paris.
It does not have any subsidiaries and is thus not required to present consolidated financial statements under IFRS rules. Its annual financial statements are therefore prepared in accordance with the French accounting standards and principles.
Abivax's interim financial statements for the sixmonth period ending 30 June 2020 were adopted on 22 September 2020 by the Board of Directors.
These financial statements are comprised of a balance sheet totalling €49,811,000, an income statement showing a loss of €15,422,000, a cash flow statement, a statement of changes in shareholders' equity and the Notes to the financial statements.
The interim financial statements are presented in thousands of euros. Unless otherwise indicated, the figures provided in the Notes are expressed in thousands of euros.
The interim financial statements as at 30/06/2020 were prepared in accordance with the standards defined by ANC Regulation No. 2015-06, and with Articles L. 123-12 to L. 123-28 and R. 123-172 to R. 123-208 of the French Commercial Code.
The basic method selected for the valuation of accounting items is the historical cost method.
Accounting conventions have been applied in good faith in accordance with the principle of prudence and the following basic principles:
The going concern assumption has been applied by the Board of Directors despite the losses that have accumulated since the founding of the Company. Taking into account the level of cash available at 30 June 2020, the €36 million loan obtained under the COVID-19 programme from Bpifrance, the financing line of credit with Kepler Cheuvreux, and the ongoing discussions for acquiring private funding, the Company should be able to cover its research project expenses and meet its financial commitments until the last quarter of 2020. Research and finalisation of public or private funding or partnering would enable it to meet its deadlines until the second quarter of 2021,
- Consistency of accounting methods from one financial year to the next,
- Independence of financial years.
Accounting conventions have also been applied in accordance with the general rules on the preparation and presentation of annual financial statements.
Property, plant and equipment and intangible assets are valued at acquisition cost for assets acquired against payment, at production cost for assets produced by the Company, and at market value for assets acquired for free or via an exchange.
The cost of an asset is made up of its purchase price, including non-recoverable customs duties and taxes, net of rebates, trade discounts and cash discounts, and all directly attributable costs incurred to install and commission the asset according to its intended use. Any transfer costs, fees or commissions and legal costs associated with the acquisition are added to the acquisition cost.
Any costs that do not form part of the asset acquisition price and which may not be directly attributed to the costs incurred in installing and commissioning the asset according to its intended use are recognised as expenses.
Amortisation and depreciation are calculated on a straight-line basis over the likely useful life of the asset.
For simplicity, the amortisation or depreciation term applied for assets that cannot be broken down further is the asset's useful life.
The technical losses recorded when subsidiaries are acquired by means of a universal transfer of assets and liabilities are similar to goodwill and are not amortised.
At the end of each financial year, the technical losses resulting from the mergers of Splicos and Wittycell are compared to the market values of the molecules produced by the technological platforms associated with each company: "Modulation of RNA biogenesis" or the "splicing" platform for Splicos and the "iNKT agonists" technological platform for Wittycell. The Zophis technical loss was fully impaired when the universal transfer of assets and liabilities was carried out, as the partnership (licence option agreement regarding patents with the French National Institute for Agricultural Research (INRA) transferred by Zophis was abandoned.
If the estimated market value of the molecules is less than the corresponding technical loss, a provision for impairment is recorded to reduce the technical loss shown in the accounts to the market value of the projects.
In order to estimate the market value of a project, two references are taken into account:
the adjusted net current value of expected cash flows generated by the sale of the molecules;
the prices of recent transactions for acquisition or licensing agreements for comparable projects (therapeutic indication, stage of development, market size, etc.).
If there are discrepancies between the valuations obtained by these two methods, the current net value is used.
In the event of major adverse change in the development of the technology platform that would undermine its operation, the technical loss will be impaired in full.
If an impairment is recognised, it may not be reversed in the event of a subsequent improvement in the market value of the projects.
In accordance with ANC Regulation 2015-6 applicable from 1 January 2016, these technical losses were kept in goodwill and not allocated to tangible assets contributed because they correspond to non-capitalised expenditure incurred by the absorbed companies during the financial years preceding the full transfer of assets and liabilities.
This goodwill is not amortised, as the period during which the Company may receive economic benefits is indefinite. In fact, this goodwill concerns several projects that are at different stages in their development and for which the duration of any economic benefits cannot currently be estimated. Accordingly, given the current progress of the ongoing research projects, the duration of use for this goodwill is not restricted.
Receivables are recorded at nominal value. A provision for impairment is recognised when the net asset value is lower than the carrying amount.
Transactions in foreign currencies are recorded at their equivalent value at the date of the transaction. Payables, receivables and cash in foreign currencies are reported on the balance sheet at period-end exchange rates. The difference resulting from the discounting of foreign currency payables and receivables at this rate is shown on the balance sheet under "Translation adjustments".
Unrealised currency translation losses not fully or partially offset by gains are subject to a provision for risks.
Because of its business relationships with foreign service providers, the Company is exposed to foreign exchange risk for the US dollar, the Singaporean dollar, the Swiss franc and the British pound.
Advances received from public organisations to finance the Company's research activities that are subject to conditional repayments are posted to liabilities under "Other equity – Conditional advances".
Other advances received that are not subject to conditional repayments are posted under "Miscellaneous borrowings and financial debt". Interest accrued on these advances is posted under liabilities per the same rules.
As from the financial year starting on or after 1 January 2018, the Company has amended the presentation in its annual financial statements of repayable advances to achieve consistency with the grants received under the Bpifrance contract. Refundable advances are recognised as soon as their payment is considered certain in the light of contractual conditions. This change has no impact on the outcome.
Any grants received are recorded upon confirmation of the corresponding receivable, in accordance with the conditions imposed on the grant. Operating grants are booked as operating income taking into account, where applicable, the rate at which they are spent to ensure compliance with the principle of matching expenditure with income.
For contracts that subcontract certain research services to third parties, progress is assessed at each closing date to allow the cost of services already provided to be booked as accrued expenses.
The company's research and development costs are booked as expenses for the period in which they are incurred.
The Company's former subsidiaries have applied the same principle. However, due to their acquisition by the company via a full transfer of assets and liabilities which took effect in 2014, expenses booked prior to the effective date (31 July 2014 for Wittycell and Zophis; 31 October 2014 for Splicos) are added to the technical losses (goodwill) booked as assets as at 31 December 2014. These technical losses are not amortised but their value is assessed once a year and a provision for impairment is booked if necessary, as was the case in 2014 for the technical loss generated when Zophis was acquired.
These costs are offset against the amount of the share issue premium applicable to the capital increase, if the premium is sufficient. If applicable, the excess costs are recognised as expenses. These expenses are offset before tax, because the Company has been structurally loss-making during its development phase.
The Company's collective agreement provides for retirement benefits. No specific agreement has been signed. There are no provisions for the corresponding commitments, but the latter are described in these Notes.
Retirement benefits are calculated by applying a method that takes into account projected careerend salary, staff turnover rate, life expectancy and predicted payment discount assumptions.
The actuarial assumptions used are as follows:
The tax credits recognised as assets under "Other receivables" include the research tax credit (Crédit d'Impôt Recherche or CIR). Also included under Other receivables are VAT credits for which reimbursement has been requested.
This tax credit was calculated on the basis of transactions that were actually carried out during the first half of 2020 and do not take into account any unforeseen transactions in the second half of the year. For example, the research tax credit will inevitably be negatively impacted in the event that grants or repayable advances are received for research and development projects. Grants and repayable advances that will definitely be received during the second half of the year were deducted from the CIR at 30 June 2020 at the rate of 100% of the expected amount.
Due to the receipt of grants and advances repayable in the first half of the year and the application of the ceiling on subcontracting expenditure, no research tax credit was recognised for this period.
This tax credit offsets the corporate income tax payable for the financial year in which it was recorded. In the absence of taxable earnings, the Company, considered an SME under EU regulations, may request an immediate refund when it files its tax return for the relevant financial year.
| in thousands of euros | At the beginning of the financial year |
Increase | Decrease | At the statement date |
|---|---|---|---|---|
| Goodwill | 32,745 | 32,745 | ||
| Other intangible asset items | 96 | 4 | 100 | |
| Intangible assets | 32,841 | 4 | 0 | 32,845 |
| • Technical facilities, industrial tools and equipment |
420 | 0 | 0 | 420 |
| • Office and IT equipment, furniture |
148 | 3 | 0 | 151 |
| Property, plant and equipment | 568 | 3 | 0 | 571 |
| Other long-term investments (treasury shares) | 227 | 339 | 264 | 302 |
| Loans and other financial assets | 1031 | 430 | 839 | 623 |
| Financial assets | 1,259 | 769 | 1,103 | 925 |
| Fixed assets | 34,668 | 776 | 1,103 | 34,341 |
| in thousands of euros | 30/06/2020 | 31/12/2019 | Variation |
|---|---|---|---|
| Purchased assets | |||
| Revalued assets | |||
| Contributions in kind | 32,745 | 32,745 | 0 |
| Total | 32,745 | 32,745 | 0 |
Intangible assets consist primarily of technical losses relating to the universal transfers of assets and liabilities carried out during the second half of 2014.
Technical losses were maintained in the absence of any indication of impairment over the period.
During the second half of financial year 2014, three universal transfers of assets and liabilities were completed: Wittycell and Zophis were absorbed on 31 July 2014 and Splicos was absorbed on 31 October 2014. These three transactions resulted in the recording of technical losses, which replaced contributed equity under Assets in the amount of €32,745,000.
These technical losses represent the differences between the net assets received as measured at the effective accounting date and the book value of the holdings at Abivax for each of the companies absorbed. These are technical losses and not financial losses, since they account for the value of the research and development costs incurred by these three predecessor companies that was recognised by Abivax upon acquisition of the holdings, plus that of the research and development programmes undertaken in early 2014. These research and development costs were not capitalised by the three dissolved companies, but instead were expensed as incurred.
Property, plant and equipment consist primarily of laboratory and research equipment and IT equipment.
Financial assets correspond primarily to items relating to the liquidity agreement signed by the Company at the end of June 2015 and to security deposits paid for the premises occupied by the Company and in as part of the bond loan taken from Kreos in July 2018 and June 2019.
Transactions related to the liquidity agreement are recognised in accordance with recommendation no. 98-D of the Emergency Committee (Comité d'urgence, CU) of the French National Accounting Board (Conseil national de la comptabilité, CNC) and with bulletin no. 137 of March 2005 of the French National Institute of Auditors (Compagnie nationale des commissaires aux comptes, CNCC):
The liquidity agreement was signed on 26 June 2015 for a period of 12 months and renews automatically. A sum of €1 million was paid to the provider when the agreement was signed and the first transactions to build up a reserve of shares were carried out between 26 and 29 June 2015. The company requested a cash refund of €500,000 in April 2020.
At 30 June 2020, the company held 17,100 treasury shares via this liquidity agreement, i.e. less than 10% of its capital, for an acquisition cost of €302,000. The balance of the cash account with the service provider is €92,000.
| In thousands of euros | Quantity | Average price in euros* |
Book value of shares held |
Other financial assets |
|---|---|---|---|---|
| Balance at 31 December 2018 | 23,970 | 8 | 180 | 426 |
| Purchases | 30,729 | 9.46 | 291 | -291 |
| Sales | 27,299 | 9.72 | 265 | 265 |
| Realised capital gains or losses | 48 | |||
| Balance at 30 June 2019 | 27,400 | 9 | 254 | 401 |
| Purchases | 57,569 | 9.92 | 571 | -571 |
| Sales | 60,609 | 10.66 | 646 | 646 |
| Realised capital gains or losses | 122 | |||
| Balance at 31 December 2019 | 20,930 | 11 | 227 | 501 |
| Purchases | 18,977 | 17.86 | 339 | -339 |
| Sales | 22,807 | 18.87 | 430 | 430 |
| Realised capital gains or losses | 166 | |||
| Balance at 30 June 2020 | 17,100 | 18 | 302 | 92 |
The transactions related to the liquidity agreement are listed in the table below:
*average values for 2020, for example, €18 = €302,000/17,100 shares
The share price at 30 June 2020 was €20.8 the market value at 30 June 2020 of the treasury shares was therefore €356,000.
| in thousands of euros | At the beginning of the financial year |
Increase | Decrease | At the statement date |
|---|---|---|---|---|
| Other intangible asset items | 11 | 0 | 11 | |
| Intangible assets | 11 | 0 | 0 | 11 |
| • Technical facilities, industrial tools and equipment |
317 | 20 | 0 | 337 |
| • Office and IT equipment, furniture |
117 | 12 | 0 | 129 |
| Property, plant and equipment | 434 | 33 | 0 | 467 |
| Financial assets | ||||
| Fixed assets | 445 | 33 | 0 | 478 |
| in thousands of euros | Impairment at the beginning of the financial year |
Provisions for the financial year |
Reversals for the financial year |
Impairment at the end of the financial year |
|---|---|---|---|---|
| Intangible assets | 740 | 740 | ||
| Property, plant and equipment | ||||
| Financial assets | ||||
| Total | 740 | 740 |
The total amount of Receivables and Other receivables at the end of the year was €5,254,000, or €3,863,000 excluding issuance and termination costs related to the Kreos loan. The detailed classification of receivables by maturity date is as follows:
| in thousands of euros | Gross amount |
Maturities of less than one year |
Maturities of more than one year |
|---|---|---|---|
| Fixed asset receivables: | |||
| Other financial assets | 623 | 623 | |
| Payables on current assets: | |||
| Advances and deposits paid on orders | |||
| Trade receivables | 7 | 7 | |
| Social security and other social welfare bodies | |||
| Income tax | 427 | 427 | |
| VAT | 2,439 | 2,439 | |
| Grants receivable | |||
| Repayable advance receivable | |||
| Other receivables | 1,408 | 1,408 | |
| Prepaid expenses | 351 | 351 | |
| Total | 5,254 | 4,632 | 623 |
Receivables on fixed assets correspond to the amount available under the liquidity agreement entered into by Abivax and deposits and guarantees paid. Other payables on current assets are primarily composed of:
| in thousands of euros | Amount |
|---|---|
| 2014 CIR balance receivable (including deferred payment interest) |
64 |
| 2019 CIR balance (including deferred payment interest) | 363 |
| VAT | 2,439 |
| Trade receivables-CIFRE revenue | 7 |
| Reimbursement premium - Kreos | 1,183 |
| Loan issue costs - Kreos | 208 |
| Other receivables | 17 |
| Prepaid expenses | 351 |
| Total | 4,632 |
| in thousands of euros | Operating expenses |
Financial expenses |
Extraordinary expenses |
|---|---|---|---|
| Prepaid expenses | 351 | ||
| Total | 351 |
Prepaid expenses are broken down as follows:
| in thousands of euros | Amount |
|---|---|
| Leasing of equipment and offices | 72 |
| Other operating expenses | 76 |
| General and clinical trial insurance | 203 |
| in thousands of euros | Amount |
|---|---|
| Invoice to be issued | 4 |
| Continuing education | 7 |
| Other receivables/Insurance reimbursement | 0 |
| Other receivable/Supplier Equity | 9 |
| Grants and repayable advances receivable | |
| Total | 20 |
| in thousands of euros | 30/06/2020 | Immediate availability |
Available in under a month |
|
|---|---|---|---|---|
| Term deposits | ||||
| SICAV/UCITS | 6 | 6 | ||
| Cash and cash equivalents | 12,050 | 12,050 | ||
| Total | 12,056 | 12,056 | 0 |
The financial information in this table is expressed in thousands of euros.
| Number of shares issued |
Capital | Premiums | BCEs/ BSAs |
Retained earnings |
Total | |
|---|---|---|---|---|---|---|
| At 31 December 2018 | 10,199,189 | 102 | 90,758 | 283 | -62,398 | 28,744 |
| Share offering – BoD Meeting 9 July 2019 | 1,500 000 | 15 | 11,985 | 12,000 | ||
| Exercise of founder warrants/stock subscription warrants |
294,770 | 3 | 3 | |||
| Kepler Cheuvreux equity line | 208,000 | 2 | 1,776 | 1,778 | ||
| Issue costs | -116 | -116 | ||||
| Stock subscription warrants issued | 1 | 1 | ||||
| 2019 loss | -30,636 | -30,636 | ||||
| At 31 December 2019 | 12,201 959 | 122 | 104,403 | 283 | -93,032 | 11,776 |
| Exercise of founder warrants/stock subscription warrants |
26,310 | 0 | 54 | 55 | ||
| Kepler Cheuvreux equity line Stock subscription warrants issued |
0 | 0 | ||||
| Allocation to retained earnings on issue premium |
-93,033 | 93,033 | 0 | |||
| Loss at 06/2020 | -15,422 | -15,422 | ||||
| At 30 June 2020 | 12,228 269 | 122 | 11,425 | 283 | -15,422 | -3,592 |
The exercise of 1,300 BCE-2016-1 warrants on 7 January 2020, resulting in the issuance of 1,300 Company shares, resulted in an increase in the share capital of €13.00, raising the share capital from €122,019.59 to €122,032.59.
The exercise of 164 BSA-2014-3 warrants on 11 January 2020, resulting in the issuance of 16,400 Company shares, resulted in an increase in the share capital of €164.00, raising the share capital from €122,032.59 to €122,196.59.
The exercise of 3,000 BCE-2016-1 warrants on 16 January 2020, resulting in the issuance of 3,000 Company shares, resulted an increase in the share capital of €30.00, raising the share capital from €122,196.59 to €122,226.59.
The exercise of 10 BCE-2018-1 on 17 January 2020, resulting in the issuance of 10 Company shares, shares, resulted an increase in the share capital of €0.10, raising the share capital from €122,226.59 to €122,226.69.
The exercise of 1,400 BCE-2016-1 warrants on 22 January 2020, resulting in the creation of 1,400 Company shares, resulted an increase in the share capital of 14.00, raising the share capital from €122,226.69 to €122,240.69.
The exercise of 1,600 BCE-2016-1 warrants on 11 February 2020, resulting in the issuance of 1,600 Company shares, resulted an increase in the share capital of €16.00, raising the share capital from €122,240.69 to €122,256.69.
The Board of Directors has recognised all these capital increases.
The exercise of 26 BSA-2014-7 warrants on 17 March 2020, resulting in the issuance of 2,600 Company
shares, resulted an increase in the share capital of €26.00, raising the share capital it from €122,256.69 to €122,282.69.
The Board of Directors has not yet recognised this capital increase.
The capitalisation table below provides details of the shareholding at 30/06/2020:
| 30 June 2020 | Number of shares |
Undiluted % (capital) |
|
|---|---|---|---|
| Holding Incubatrice Medical Devices | 210,970 | 1.73% | |
| Truffle Capital | 5,414,745 | 44.28% | |
| Sofinnova Crossover | 1,500,000 | 12.27% | |
| Management | 224,240 | 1.83% | |
| Board of Directors | 721,011 | 5.90% | |
| Employees | 5,838 | 0.05% | |
| Other* | 150,544 | 1.23% | |
| Treasury shares | 17,100 | 0.14% | |
| Floating | 3,983,821 | 32.58% | |
| Total | 12,228,269 | 100% |
Other*: Long-standing minority shareholders or stock subscription warrant (BSA)/founder warrant (BCE) holders, Kepler Cheuvreux (based on the ownership disclosure thresholds declared on 3 July 2019) and former employees of the Company, former Board members and certain committee members.
The Company issued securities granting access to its capital (BCEs, or founder warrants and BSAs, or stock subscription warrants) detailed in the table provided below (data current as at 30 June 2020)
| Issued | Subscribed | Exercised | Expired | Balance | Number of shares to be issued |
|
|---|---|---|---|---|---|---|
| BCE-2014-1 | 2,750 | 2,750 | 2,750 | 0 | 0 | 0 |
| BCE-2014-2 | 2,750 | 2,750 | 1,750 | 0 | 1,000 | 100,000 |
| BCE-2014-3 | 1,389 | 1,389 | 763 | 626 | 0 | 0 |
| BCE-2014-4 | 984 | 984 | 800 | 0 | 184 | 18,400 |
| BCE-2014-5 | 197 | 197 | 28 | 169 | 0 | 0 |
| BCE-2014-6 | 525 | 525 | 197 | 328 | 0 | 0 |
| BCE-2014-7 | 1,650 | 1,650 | 0 | 1,650 | 0 | 0 |
| BCE-2015-9 | 202,122 | 202,122 | 0 | 202,122 | 0 | 0 |
| BCE-2016-1 | 84,000 | 84,000 | 9,810 | 17,499 | 56,691 | 56,691 |
| BCE-2017-1 | 67,374 | 67,374 | 0 | 0 | 67,374 | 67,374 |
| BCE-2017-2 | 150,000 | 150,000 | 0 | 0 | 150,000 | 150,000 |
| BCE-2017-3 | 101,061 | 101,061 | 0 | 0 | 101,061 | 101,061 |
| BCE-2017-4 | 67,374 | 67,374 | 0 | 0 | 67,374 | 67,374 |
| BCE-2017-5 | 67,374 | 67,374 | 0 | 0 | 67,374 | 67,374 |
| BCE-2018-1 | 22,000 | 22,000 | 30 | 0 | 21,970 | 21,970 |
| BCE-2018-2 | 67,374 | 67,374 | 0 | 0 | 67,374 | 67,374 |
| BCE-2018-3 | 33,687 | 33,687 | 0 | 0 | 33,687 | 33,687 |
| BCE-2018-4 | 16,843 | 16,843 | 0 | 0 | 16,843 | 16,843 |
| BCE-2018-5 | 22,000 | 22,000 | 0 | 10,000 | 12,000 | 12,000 |
| Total BCE | 911,454 | 911,454 | 16,128 | 232,394 | 662,932 | 780,148 |
| BSA-2014-1 | 394 | 394 | 394 | 0 | 0 | 0 |
| BSA-2014-2 | 677 | 677 | 448 | 229 | 0 | 0 |
| BSA-2014-3 | 1,172 | 1,008 | 228 | 264 | 680 | 68,000 |
| BSA-2014-4 | 1,315 | 1,315 | 473 | 0 | 842 | 84,160 |
| BSA-2014-5 | 787 | 787 | 0 | 328 | 459 | 45,900 |
| BSA-2014-6 | 52 | 52 | 52 | 0 | 0 | 0 |
| BSA-2014-7 | 81 | 81 | 55 | 0 | 26 | 2,600 |
| BSA-2015-9 | 122,274 | 0 | 0 | 122,274 | 0 | 0 |
| BSA-2015-11 | 96,924 | 96,924 | 0 | 0 | 96,924 | 96,924 |
| BSA-2015-12 | 82,000 | 32,800 | 0 | 65,600 | 16,400 | 16,400 |
| BSA-2017-1 | 16,400 | 16,400 | 0 | 0 | 16,400 | 16,400 |
| BSA-2018-1 | 49,200 | 32,800 | 0 | 16,400 | 32,800 | 32,800 |
| BSA-2018-2 | 32,800 | 0 | 0 | 32,800 | 0 | 0 |
| Total BSA | 404,076 | 183,238 | 1,650 | 237,895 | 164,531 | 363,184 |
| Total BCE + BSA | 1,315,530 | 1,094,692 | 17,778 | 470,289 | 827,463 | 1,143 332 |
The maximum potential dilution associated with these financial instruments issued to employees, managers, members of the Board of Directors or committees and external consultants represents 1,143 332 shares, resulting in a potential 8.55% dilution of issued capital as at 30 June 2020.
These dilutive instruments may be exercised at a preferential price, but they have a limited term. They may be exercised gradually and/or subject to the achievement of objectives previously set by the Board of Directors or by the plan rules.
| Impairment at the beginning of the financial year |
Provisions for the financial year |
Reversals for the financial year |
Impairment at the end of the financial year |
|
|---|---|---|---|---|
| Supplier allowances | ||||
| Other provisions for risks and contingencies | 0 | 0 | ||
| Provisions for foreign exchange risks | ||||
| Total provisions for risks and contingencies | 0 | 0 | ||
| Breakdown of provisions and reversals: | ||||
| Operating | ||||
| Financial | 0 | |||
| Extraordinary |
| in thousands of euros |
Balance at 31/12/2020 |
Interest accrued over the period |
Advances received over the period |
Advances repaid over the period |
Balance at 30/06/2020 |
Including conditional advances |
Including accrued interest |
|---|---|---|---|---|---|---|---|
| BPI CARENA | 2,361 | 15 | 2,377 | 2,187 | 190 | ||
| BPI EBOLA | 373 | 3 | 370 | 370 | |||
| BPI RNP-VIR | 4,081 | 21 | 4,102 | 4,032 | 70 | ||
| BPI COVID | 6,348 | 6,348 | 6,348 | ||||
| Total | 6,815 | 36 | 6,348 | 3 | 13,197 | 12,937 | 260 |
| At 30 June 2020 in thousands of euros |
Contract status |
Amount awarded |
Amount collected |
Remaining amount to be collected |
Amount repaid |
Amount to be repaid except in the event of recorded failure |
|---|---|---|---|---|---|---|
| CARENA (Grants portion) |
Ongoing | 1,397 | 1,187 | 210 | - | - |
| CARENA (Repayable advances portion) |
Ongoing | 3,830 | 2,187 | 1,643 | - | 4,397 |
| RNP-VIR (Grants portion) |
Ongoing | 2,112 | 1,122 | 990 | - | - |
| RNP-VIR (Repayable advances portion) |
Ongoing | 6,298 | 4,032 | 2,266 | - | 6,576 |
| EBOLA | Ongoing | 390 | 390 | 0 | - | 370 |
| COVID-19(Grants portion) |
Ongoing | 3,967 | 1,587 | 2,380 | - | - |
| COVID-19(Repayable advances portion) |
Ongoing | 15,869 | 6,348 | 9,521 | - | 16,576 |
Bpifrance agreement signed with Splicos in 2013 to finance the "CARENA" strategic industrial innovation project. The agreement provides for a repayable advance of €3,830,000 at a repayment rate of 50% of total planned expenditure.
At 30 June 2020, the Company had received €2,187,000, of which €1,150,000 was received in December 2013, €1,008,000 in September 2014 and €29,000 received in June 2016.
Financial returns will be made through specified payments based on the forecast of revenue generated by
direct or indirect exploitation of the products or services derived from the project.
The amounts payable by the repayment deadlines include a discount at an annual rate of 1.66%, which will be calculated in accordance with the contractual conditions.
The Company obtained Bpifrance's agreement to change key stages 3 and 4 and the repayment timetable. The repayment timetable, which is contingent upon the success of the project, is as follows:
| TOTAL | €4,397,000 |
|---|---|
| No later than 30 June 2027 | €1,747,000 |
| No later than 30 June 2026 | €1,100,000 |
| No later than 30 June 2025 | €750,000 |
| No later than 30 June 2024 | €500,000 |
| No later than 30 June 2023 | €300,000 |
This amount corresponds to the maximum amount of repayable advances initially provided for in the contract. In the event that the total amount of repayable advances actually paid by Bpifrance is less than the amount originally agreed, the repayments indicated above will be reduced in proportion to the amounts paid.
If applicable, the Company will also have to pay an annuity of 50% of the proceeds generated by the sale of the intellectual property rights resulting from the project, as well as the sale of the prototypes, preproduction and models produced as part of the project.
If the advance is repaid under the conditions outlined above, the Company will pay to Bpifrance, over a period of five consecutive years after the date on which the repayment schedule ends and provided that the Company has reached cumulative pre-tax revenue greater than or equal to €50 million, an amount equal to 1.20% of the annual revenue generated from the sale of the products developed as part of the project. The supplementary payments amount is capped at €6,800,000.
The total period, including fixed payments and incentive payments, is limited to 15 years.
Bpifrance and Occitanie region agreement to finance a project to develop a treatment for the EBOLA virus. The agreement provides for a repayable advance of €130,000 for the Occitanie region at a repayment rate of 16.55% of total planned expenditure. The agreement provides for a repayable advance of €260,000 for the BPI at a repayment rate of 33.11% of total planned expenditure.
At 30 June 2020, the amount received by the company was €390,000, of which €300,000 was received in August 2017 (€100,000 for the Occitanie region and €200,000 for BPI), and €90,000 received in November 2019 (€30,000 for the Occitanie region and €60,000 for BPI).
In 2019, €17,000 was already reimbursed, of which €13,000 for BPI and €3,000 for the Occitanie region. In the first half of 2020, €3,000 was reimbursed for the Occitanie Region. At 30 June 2020, the remaining balance to be repaid is €370,000. In view of COVID-19, the maturities of March (€10,000) and June (€10,000) were deferred and were effectively repaid in July 2020.
The repayment timetable, which is not contingent upon the success of the project, is as follows:
| 31/03/2020 | 10,000 |
|---|---|
| 30/06/2020 | 10,000 |
| 30/09/2020 | 15,000 |
| 31/12/2020 | 15,000 |
| 31/03/2021 | 15,000 |
| 30/06/2021 | 15,000 |
| 30/09/2021 | 20,000 |
| 31/12/2021 | 20,000 |
| 31/03/2022 | 20,000 |
| 30/06/2022 | 20,000 |
| 30/09/2022 | 25,000 |
| 31/12/2022 | 25,000 |
| 31/03/2023 | 25,000 |
| 30/06/2023 | 25,000 |
| 30/09/2023 | 27,500 |
| 31/12/2023 | 27,500 |
| 31/03/2024 | 27,500 |
| 30/06/2024 | 27,500 |
| Total | 370,000 |
This amount corresponds to the maximum amount of repayable advances initially stipulated in the agreement and actually received by the company. In September 2019, Abivax decided to terminate this programme, due to the existence of a vaccine in the process of being licensed for this indication as well as changes in the macroeconomic climate for public funding.
Bpifrance agreement to finance the "RNP-VIR" Structuring R&D Projects for Competitiveness project. This financing was granted under the French Future Investments Programme.
The agreement provides for a repayable advance of €6,298,000 at a repayment rate of 50% of total planned expenditure.
At 30 June 2020, the Company had received €4,032,000, of which €1,756,000 was received in September 2017, €346,000 in August 2018 and €1,930,000 in November 2019.
Financial returns will be made through specified payments based on the forecast of revenue generated by direct or indirect exploitation of the products or services derived from the project.
The amount of repayment deadlines takes into account a discount at the annual rate of 0.95% calculated according to the terms of the agreement.
The repayment timetable, which is contingent upon the success of the project, is as follows:
| TOTAL | €6,576,000 |
|---|---|
| No later than 31 December 2025 | €1,644,000 |
| No later than 31 December 2024 | €1,644,000 |
| No later than 31 December 2023 | €1,644,000 |
| No later than 31 December 2022 | €1,644,000 |
This amount corresponds to the maximum amount of repayable advances initially stipulated in the agreement. In the event that the total amount of repayable advances actually paid by Bpifrance is less than the amount originally agreed, the repayments indicated above will be reduced in proportion to the amounts paid.
If applicable, the Company will also have to pay an annuity of 50% of the proceeds generated by the sale of the intellectual property rights resulting from the project, as well as the sale of the prototypes, preproduction and models produced as part of the project.
If the advance is repaid under the conditions outlined above, the Company will pay to Bpifrance, over a period of five consecutive years following the date on which the repayment schedule ends and provided that the company has reached cumulative pre-tax revenue greater than or equal to €25 million, an amount equal to 3% of the annual revenue generated from the sale of products developed as part of the project.
The amount of additional payments is capped at €5,500,000.
The total period, including fixed payments and incentive payments, is limited to 15 years.
Bpifrance agreement to finance the "COVID-19" Structuring R&D Projects for Competitiveness project. This financing was granted under the French Future Investments Programme.
This study is carried out under the full ownership of Abivax with the collaboration of the University Hospital of Nice, which directly manages part of the financing of the programme, notably for the ABX464 COVID-19 "miR-AGE" clinical trial. The total amount of aid is €36,010,000, of which €19,836,000 is allocated to Abivax (€15,869,000 in repayable advances and €3,967,000 in subsidies), and €16,174 K is allocated to the University Hospital of Nice (100% subsidies at a rate of 100% of estimated expenditure).
The total repayable advance for the Abivax part is €15,869,000 at a repayment rate of 64% of total planned expenditure.
At 30 June 2020, the amount of the repayable advance received in June 2020 was €6,348,000.
Financial returns will be made through specified payments based on the forecast of revenue generated by direct or indirect exploitation of the products or services derived from the project.
The amount of repayment deadlines takes into account a discount at the annual rate of 0.78% calculated according to the terms of the agreement.
The fixed repayment schedule, which is contingent upon the success of the project, is as follows:
| No later than 31 March 2023 | €500,000 |
|---|---|
| No later than 30 June 2023 | €500,000 |
| No later than 30 September 2023 | €500,000 |
| No later than 31 December 2023 | €500,000 |
| No later than 31 March 2024 | €650,000 |
| No later than 30 June 2024 | €650,000 |
| No later than 30 September 2024 | €650,000 |
| No later than 31 December 2024 | €650,000 |
| No later than 31 March 2025 | €835,000 |
| No later than 30 June 2025 | €835,000 |
| No later than 30 September 2025 | €835,000 |
| No later than 31 December 2025 | €835,000 |
| No later than 31 March 2028 | €708,000 |
|---|---|
| No later than 31 December 2027 | €1,000,000 |
| No later than 30 September 2027 | €1,000,000 |
| No later than 30 June 2027 | €1,000,000 |
| No later than 31 March 2027 | €1,000,000 |
| No later than 31 December 2026 | €982,000 |
| No later than 30 September 2026 | €982,000 |
| No later than 30 June 2026 | €982,000 |
| No later than 31 March 2026 | €982,000 |
This amount corresponds to the maximum amount of repayable advances initially stipulated in the agreement. In the event that the total amount of repayable advances actually paid by Bpifrance is less than the amount originally agreed, the repayments indicated above will be reduced in proportion to the amounts paid. In particular, this latter scenario would arise if ABX464 were to be brought to market more quickly, owing to the results from current development for the COVID-19 indication quickly proving satisfactory.
If applicable, the Company will also have to pay an annuity of 50% of the proceeds from the sale of the intellectual property rights resulting from the project, as well as the sale of the prototypes, preproduction and models produced under the project.
If the advance is repaid under the conditions outlined above, the company will pay Bpifrance, for four consecutive years after the date on which the repayment timetable ends and as soon as the company has achieved cumulative revenue, excluding taxes, of €1 million or more, an amount equal to 1.5% of the annual income generated from the sale of the products developed within the project.
The amount of additional payments is, however, capped at a total of €3,340,000.
The total period, including fixed payments and incentive payments, is limited to 15 years.
The agreement with Bpifrance provides for a maximum payment of €1,397,000, i.e., a grant rate of 45% of the industrial research expenses for specific steps. At 30 June 2020, the Company had received a total amount of €1,187,000.
The agreement with Bpifrance provides for a maximum payment of €2,111,000, i.e., a grant rate of 50% of the industrial research expenses for specific steps. At 30 June 2020, the company already received an amount of €1,122,000 (of which €347,000 was received in September 2017, €485,000 in August 2018 and €290,000 in November 2019).
The agreement with Bpifrance provides for a maximum payment of €3,967,000, i.e., a grant rate of 16% of the industrial research expenses for specific steps. At 30 June 2020, the company had received €1,587,000.
Total liabilities at the closing date amounted to €40,207,000 and the breakdown by maturity is as follows:
| in thousands of euros | Gross amount |
Maturities of less than one year |
Maturities of more than one year |
Maturities of more than five years |
|---|---|---|---|---|
| Convertible bonds | 4,000 | 4,000 | ||
| including tranche A | 2,000 | 2,000 | ||
| including tranche B | 2,000 | 2,000 | ||
| Non-convertible bonds | 15,480 | 4,282 | 11,199 | |
| including tranche A | 6,798 | 2,219 | 4,579 | |
| including tranche B | 8,682 | 2,063 | 6,620 | |
| Trade payables and related accounts | 13,508 | 13,508 | ||
| Borrowings and debts with credit institutions |
5,000 | 5,000 | ||
| Personnel and related accounts | 782 | 782 | ||
| Social security and other social welfare bodies |
1,216 | 1,216 | ||
| Other taxes and duties and similar payments |
190 | 190 | ||
| Other liabilities (**) | 30 | 30 | ||
| Total | 40,206 | 20,008 | 20,199 | 0 |
| (*) Loans taken out during the financial year |
5,000 | |||
| () Loans repaid during the financial year (*) Including intra-group |
1,263 |
Recognition of the termination fees for the bond subscribed in 2019 and in 2018 were recognised as "Bond redemption premium" raises the amount of financial debt ("non-convertible bonds") by an additional €1,800,000.
| in thousands of euros | Amount |
|---|---|
| Suppliers – Invoices Not received | 5,909 |
| Provision for paid leave | 329 |
| Accrued personnel expenses | 454 |
| Provision for social security contributions |
138 |
| Other accrued social security contributions |
178 |
| State - Other accrued expenses | 70 |
| Apprenticeship levy | 13 |
| Social housing tax | 21 |
| Miscellaneous accrued expenses | 7 |
| Total | 7,118 |
As indicated in the accounting rules and policies, the Company has expensed all its research and development costs for the year.
These expenses amounted to a total of €13,468,000 for the first half of 2020, compared with €14,981,000 for the first half of 2019 (€29,007,000 for the whole of 2019).
Some of these research and development costs relate to work subcontracted to partners. These subcontracting expenses amounted to €10,063,000 for the first half of 2020, compared with €11,927,000 for the first half of 2019 (€22,434,000 for the whole of 2019).
Because the Company carries out research and development activities, it is eligible for the French Research Tax Credit (CIR).
In 2015, the company had to pre-finance its 2014 CIR. As guarantees were provided to secure this prefinancing, there are still some amounts yet to be recovered; a total of €64,000 is set to be returned provided that there is no dispute.
The research tax credit for 2019 amounted to €4,251,000. It was pre-financed by an authorised body for €3,783,000 in February 2020. Due to the guarantees of the pre-financer and the absence of repayment by the tax authorities, there are still sums to be recovered for a total of €363,000.
The company's research and development activity during the first half of 2020 did not allow the calculation of a research tax credit. In fact, the amounts of deductible public funding received and to be received in respect of research and development activities in the first half of 2020 are deducted from expenses incurred and result in an insignificant research tax credit for the first half of 2020.
As the Company is a loss-making entity, it does not pay tax. The amount recorded under "Income tax" in the income statement corresponds to income from the research tax credit.
The Company's tax loss and amortisation and depreciation carry-forwards amounted to €156,373,000 at 30 June 2020.
The offsetting of these losses is capped at 50% of the taxable profit for the year. This limit is applicable to the portion of the profits that exceeds €1 million. The unused loss balance remains deferrable to subsequent financial years and may be written off under the same conditions with no cut-off date.
| in thousands of euros | Related companies |
Companies linked by a participating interest |
|---|---|---|
| Total assets | ||
| Advances and deposits paid on orders | 0 | |
| Total Receivables | 0 | |
| Trade payables and related accounts | 0 | |
| Total Payables | 0 |
None.
| in thousands of euros | |
|---|---|
| Pension commitment | 636 |
| Lease commitment | |
| Other commitments given | 30,239 |
| of which firm orders placed | 30,239 |
| Total | 30,875 |
| Includes amounts relating to: | |
| Executives | 70 |
The development programmes for several of the Company's products are part of long-term licensing agreements with academic institutions and research centres to develop its technology platforms and with patent-owning partners to supplement the portfolio of drug candidates.
These agreements include significant fixed and variable financial commitments. Fixed payment commitments are conditional on the achievement of various contractually defined milestones. The associated expense will be booked once all the contractual conditions have been met. Variable commitments consist of future royalty payments calculated based on the revenues generated once the developed products are marketed or when sub-licences are granted to third parties.
The main licensing agreements involving the product portfolio are as follows:
A "Modulation of RNA Biogenesis" platform, based on technologies developed jointly by the CNRS (Montpellier, France) and the Institut Curie (Orsay, France).
An "Immune Enhancer" platform based on intellectual property from the Scripps Research Institute (United States).
In order to carry out its development programmes, the Company frequently enters into cooperation agreements with public- or private-sector partners or subcontractors. Owing to the length of these programmes, these agreements may be for periods of several years and involve significant financial commitments. In order to carry out its development programmes, the Company frequently enters into cooperation agreements with public- or private-sector partners or subcontractors. Owing to the length of these programmes, these agreements may be for periods of several years and involve significant financial commitments. The amount of orders committed to but not yet supplied (and thus not recognised as either invoices receivable or trade accounts payable) was an estimated €30,239,000 at 30 June 2020.
The amount of commitments made for pensions, supplementary pensions and similar benefits: €636,000. Recommendation 03-R-01 of 1 April 2003 of the CNC has been applied for defined benefit schemes.
The maximum amounts receivable by Abivax after 30 June 2020 under the "Carena" and "RNP-VIR" and "COVID-19" innovation agreements entered into with Bpifrance, subject to the provision of evidence to support the forecast expenses and the completion of key scientific stages, are as follows:
| in thousands of euros | |
|---|---|
| RNP-VIR repayable advance | 2,266 |
| CARENA repayable advance | 1,643 |
| Repayable advance COVID-19 | 9,521 |
| RNP-VIR Grant | 989 |
| CARENA Grant | 210 |
| COVID-19 grant | 2,380 |
| Total | 17,009 |
| Includes amounts relating to: | |
| Executives | None |
At 30 June 2020, the Company had an average of 27 employees (compared to 25.75 employees at 31 December 2019).
| 30/06/2020 | 31/12/2019 | |
|---|---|---|
| Managerial personnel | 22 | 21.25 |
| Non-managerial personnel |
4 | 3.5 |
| Corporate officers | 1 | 1 |
| Total | 27 | 25.75 |
| 30/06/2020 | 31/12/2019 | |
|---|---|---|
| Paris | 13 | 12.25 |
| Montpellier | 14 | 13.5 |
| Total | 27 | 25.75 |
| in thousands of euros | 30/06/2020 | 31/12/2019 |
|---|---|---|
| Audit Statutory Auditor, certification of individual financial |
||
| statements • Issuer |
46 | 78 |
| Services other than the certification of accounts • Issuer |
0 | 10 |
| Total | 46* | 88* |
* Of this €46,000, only €41,000 corresponds to work carried out for the 2020 financial year, and €5,000 corresponds to the adjustment of fees provisioned at 31 December 2019.
* Of the €88,000, only €75,000 corresponds to work actually completed during the financial year ended 31 December 2019. The additional €12,000 corresponds to an adjustment for fees provisioned as at 31 December 2018.
| in thousands of euros | Expenses | Income |
|---|---|---|
| Premiums on sale of treasury shares Extraordinary taxes Other extraordinary expenses: |
1 | 167 |
| Prov. Depreciat. Amort. Extraordinary/Impairment treasury shares |
0 | |
| Total | 1 | 167 |
The extraordinary result in the first half of 2020 is a loss of €166,000. It is comprised of:
I certify that, to the best of my knowledge, the accounts presented for the half-year ended in the half-year financial report have been prepared in accordance with the applicable French accounting standards and that they provide a true and fair view of the assets and liabilities, the financial position and results of the Company. I also certify that the half-year activity report (provided in pages 4 to 17) presents, to the best of my knowledge, a true and fair view of the important events that occurred in the first six months of the financial year and their impact on the interim financial statements, the main transactions between related parties and a description of the main risks and uncertainties for the remaining six months of the financial year.
[Document signed in the French version]
Pr. Hartmut Ehrlich Chief Executive Officer
Statutory Auditors' Review Report on the Interim Financial Information
(For the period from January 1, 2020 to June 30, 2020)

(For the period from January 1, 2020 to June 30, 2020)
This is a free translation into English of the Statutory auditors' review report issued in French and is provided solely for the convenience of English-speaking readers. This report should be read in conjunction with, and construed in accordance with, French law and professional standards applicable in France.
To the shareholders,
5, rue de La Baume
75008 Paris
In compliance with the assignment entrusted to us by your General Meetings and in accordance with the requirements of article L. 451-1-2-III of the French Monetary and Financial Code ("Code monétaire et financier"), we hereby report to you on:
These interim financial statements have been established under the responsibility of the Board of Directors on the 22th September 2020, on the basis of the information available at that date in the evolving context of the Covid-19 crisis and difficulties understanding its impacts and the future outlook. Our role is to express a conclusion on these financial statements based on our review.
Sur la base de notre examen limité, nous n'avons pas relevé d'anomalies significatives de nature à remettre en cause, au regard des règles et principes comptables français, la régularité et la sincérité des comptes semestriels et l'image fidèle qu'ils donnent du patrimoine de la société et de la situation financière à la fin du semestre ainsi que du résultat du semestre écoulé de la société.
We conducted our review in accordance with professional standards applicable in France.
A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with professional standards applicable in France and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Based on our review, nothing has come to our attention that causes us to believe that the accompanying interim financial statements do not give a true and fair view of the assets and liabilities and of the financial position of the Company as at 30 June 2020, and of the results of its operations for the six-month period then ended, in accordance with French accounting principles.
We have also verified the information presented in the half-yearly financial report on the interim financial statements subject to our review.
We have no matters to report as to its fair presentation and consistency with the interim financial statements.
Neuilly-sur-Seine, 25 September 2020
The Statutory Auditor
PricewaterhouseCoopers Audit
Cédric Mazille
[Document signed in the French version]

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