UNITED STATES SECURITIES

AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

Date of report: September 27, 2023

 

Commission File Number: 001-38974

 

BIOPHYTIS S.A.

(Translation of registrant’s name into English)

 

Stanislas Veillet
Biophytis S.A.

Sorbonne University-BC 9, Bâtiment A 4ème étage

4 place Jussieu

75005 Paris, France

+33 1 44 27 23 00

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

x Form 20-F ¨ Form 40-F

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨

 

 

 

 

 

 

On September 27, 2023, Biophytis S.A. (the “Company”) issued its Interim Financial Report for the first half of fiscal year 2023. A copy of the Company’s Interim Financial Report is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

EXHIBIT LIST

Exhibit     Description
99.1     Interim Financial Report issued by the registrant on September 27, 2023

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  BIOPHYTIS S.A.
     
Date: September 27, 2023 By: /s/ Stanislas Veillet
    Name: Stanislas Veillet
    Title: Chairman and Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

 

French public limited company with a Board of Directors with share capital of €4,267,706.99
Registered office: 14 Avenue de l'Opéra – 75001 PARIS
Paris Commercial Register (RCS) 492 002 225

 

HALF-YEAR FINANCIAL REPORT

 

AS OF JUNE 30, 2023

 

 

 

 

Half-year financial report as of June 30, 2023 

 

CONTENTS

 

1.      Activity report as of June 30, 2023 4
   
  1.1 Business trends and significant events 4
   
  1.2 Analysis of consolidated income 5
   
  1.3 Cash flow and financial position 6
   
  1.4 Subsequent events 6
   
  1.5 Developments and outlook 7
   
  1.6 Risk factors 8
   
  1.7 Transactions between related parties 8
   
2.     Unaudited condensed interim consolidated financial statements under IFRS for the six-month period ended June 30, 2023 9
   
  Statement of consolidated financial position 9
   
  Statement of consolidated operations 10
   
  Statement of consolidated comprehensive loss 10
   
  Statement of changes in consolidated shareholders’ equity 11
   
  Statement of consolidated cash flows 12
   
  Notes to the unaudited interim condensed consolidated financial statements 13

 

Page 2 of 28

 

 

Half-year financial report as of June 30, 2023 

 

GENERAL NOTES

Definitions

 

In this half-year financial report, and unless otherwise indicated:

 

·The terms “Company” or “Biophytis” refer to Biophytis SA whose registered office is located at 14 Avenue de l'Opéra – 75001 PARIS, France, registered with the Paris Trade and Companies Registry under number 492 002 225 and its subsidiaries Instituto Biophytis do Brasil (Brazil) and Biophytis Inc (United States);

 

·“Financial Report” means this half-year financial report as of June 30, 2023.

 

About Biophytis

 

Biophytis SA is a clinical-stage biotechnology company specializing in the development of drug candidates for age-related diseases.

 

Sarconeos (BIO101), our lead drug candidate, is a small molecule in development for age-related neuromuscular (sarcopenia and Duchenne muscular dystrophy) and cardiorespiratory (COVID-19) diseases. Promising clinical results were obtained in the treatment of sarcopenia in an international Phase 2 study, enabling the launch of a Phase 3 study in this indication (SARA project). The safety and efficacy of Sarconeos (BIO101) in the treatment of severe COVID-19 were studied in a positive international Phase 2-3 clinical trial (COVA project), enabling the preparation of Conditional Marketing Authorization (CMA) applications in Europe and Emergency Use Authorization (EUA) applications in the United States. A pediatric formulation of Sarconeos (BIO101) is currently being developed for the treatment of Duchenne muscular dystrophy (DMD, MYODA project).

 

The Company is based in Paris, France, and Cambridge, Massachusetts. The Company’s ordinary shares are listed on Euronext Growth Paris (Ticker: ALBPS - ISIN: FR0012816825) and its ADSs (American Depositary Shares) are listed on the Nasdaq (Ticker BPTS - ISIN: US09076G1040).

 

For more information: www.biophytis.com

 

Page 3 of 28

 

 

Half-year financial report as of June 30, 2023

 

1.Activity report as of June 30, 2023

 

1.1 Business trends and significant events

 

1.1.1Research and development

 

In the first half of 2023, the Company continued to develop its main clinical and pre-clinical programs:

 

·COVA program – Development of Sarconeos (BIO101) for the prevention of respiratory deterioration in COVID-19 patients

 

In early February 2023, Biophytis announced the final results of its Phase 2-3 COVA clinical study, including data from 54 patients (of the 233 patients treated) who were missing from the Top Line analysis released on September 7, 2022. The final analysis demonstrates that the COVA study met the primary endpoint, with a 44% statistically significant reduction (p = 0.043) in the risk of respiratory failure or early death in hospitalized patients with severe COVID-19, in line with the positive Post-Hoc analysis released on November 3, 2022. Moreover, Sarconeos (BIO101) has a very good safety profile, with a lower proportion of patients with adverse events compared to the placebo (57% vs. 64%), in particular a lower frequency of serious, mostly respiratory, adverse events (25% vs. 31%).Detailed results of the study were presented at the European Respiratory Society Lung Science Conference in March 2023 in Estoril, Portugal and at the American Thoracic Society International Conference in Washington DC, United States in May 2023.

 

Based on the results, Biophytis has begun the regulatory process to give access to Sarconeos (BIO101) to hospitalized patients with severe COVID-19 at risk of respiratory failure and death as quickly as possible. To that end, the Company has developed a multi-pronged strategy:

 

-Submit applications for early access programs in key countries. In France, the application was submitted in May and a response is expected in the second half of 2023. The early access program in France will be carried out in partnership with Intsel Chimos, a pharmaceutical company based in Saint-Cloud, France that is specialized in the importation, provision and exploitation of innovative medicines to treat patients with rare and/or serious diseases for whom no other therapeutic options are available. In Brazil, an early access program was approved in 2022 to treat critically ill COVID-19 patients in intensive care units (ICUs), but was suspended pending the results of the COVA study. Based on the positive results obtained, the program is being reactivated.

 

-Submit applications for Conditional Marketing Authorization (CMA) in Europe and Emergency Use Authorization (EUA) in the United States. On August 16, 2023, the Company announced that it had received feedback from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), enabling it to plan the next regulatory steps for its COVA project dedicated to the development of Sarconeos (BIO101) for severe forms of COVID-19.

 

·SARA program – Development of Sarconeos (BIO101) for sarcopenia

 

In May 2023, the Company submitted the application for Clinical Trial Authorization (CTA) to initiate SARA-31, the first Phase 3 study in sarcopenia, on the European portal of the European Medicines Agency (EMA). A similar application was submitted to the Food and Drug Administration (FDA) at the beginning of July to launch the study in the United States.

 

The launch of the Phase 3 program follows encouraging results from the SARA-INT Phase 2b study and interactions with the health authorities in 2022. The objective of the SARA-31 Phase 3 study in sarcopenia is to evaluate the efficacy and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of mobility disability. Approximately 900 patients over 65 years of age with severe sarcopenia (3 ≤ SPPB ≤ 7) with low walking speed (4-m Gait speed ≤ 0.8 m/s) and low grip strength (HGS < 20kg for women and < 35.5 kg for men) will be included. They will be treated for a minimum of 12 months and a maximum of 36 months, receiving either the placebo or 350mg of Sarconeos (BIO101) twice daily. The primary endpoint will be the assessment of the risk of major mobility disability (MMD), measured by the ability to walk 400m in less than 15 minutes over time. In addition to the primary endpoint, the following secondary endpoints will be assessed: walking speed (4-m walking speed from the short physical performance battery (SPPB) test), handgrip strength (HGS) and patient-reported quality of life (Patient Reported Outcome SarQol, a questionnaire developed specifically for sarcopenia).

 

Page 4 of 28

 

 

Half-year financial report as of June 30, 2023

 

On August 8, 2023, Biophytis announced that it had received a positive opinion from the Belgian authorities to conduct its SARA-31 program. On September 11, 2023, the Company announced that it had also received a positive opinion from the FDA to conduct the study in the United States.

 

·Other programs

 

At the Clinical and Scientific Conference organized by the Muscular Distrophy Association (MDA) from March 19 to 22, 2023 in Dallas, Texas, the Company presented a poster with new information concerning its MYODA project for Duchenne muscular dystrophy (DMD), for which a clinical development plan is under preparation, and the therapeutic potential of BIO101 in rare neuromuscular diseases such as spinal muscular atrophy, for which promising pre-clinical results have been obtained.

 

1.1.2Financing

 

On May 11, 2023, the Company announced the successful completion of a new financing round in the form of a private placement with professional investors combined with a public offering for individual investors, for a gross amount of €2.3 million. The transaction was carried out pursuant to the 2nd and 4th resolutions of the Combined General Meeting of April 17, 2023. A total of 103,717,811 new ordinary shares, representing 32% of the Company’s share capital prior to the transaction, were issued at a price of €0.0222 per share. The per-share price included a 25% discount on the volume-weighted average price of the Biophytis shares during the five trading days prior to the transaction. The total nominal amount of the capital increase was €1,037 thousand and the total issue premium was €1,265 thousand. The new shares were listed on Euronext Growth Paris under ISIN code FR0012816825 ALBPS at the start of trading on May 15, 2023. They rank pari passu with the Company’s existing shares and have carried dividend rights since their issuance.

 

1.1.3Governance

 

At the Ordinary General Meeting of June 16, 2023, Jean Mariani was reappointed for a three-year term. Further to the resignation of Dmitri Batsis on April 27, 2023, the Board of Directors comprises four members as of the date of this Financial Report, three of whom are independent:

 

-Stanislas Veillet, Chairman and Chief Executive Officer;

-Nadine Coulm;

-Claude Allary;

-Jean Mariani.

 

1.2 Analysis of consolidated income

 

1.2.1            Net operating loss

 

The net operating loss came to €(6,524) thousand for first-half 2023 versus €(11,920) thousand for first-half 2022, reflecting the research and development costs and general and administrative expenses incurred during the period and detailed below. The Group did not generate any revenue during the first six months of the year.

 

(amounts in thousands of euros)  First-half 2022   First-half 2023 
   Personnel costs   (2,950)   (1,443)
   Purchases and external expenses   (6,435)   (3,099)
   Research tax credit   2,614    922 
   Other   (95)   (143)
Research and development costs   (6,867)   (3,763)
   Personnel costs   (2,682)   (962)
   Purchases and external expenses   (2,235)   (1,685)
   Other   (136)   (114)
General and administrative expenses   (5,053)   (2,761)
Net operating loss   (11,920)   (6,524)

 

Page 5 of 28

 

 

Half-year financial report as of June 30, 2023

 

The sharp decrease in personnel costs is primarily due to the value of instruments giving access to the Company’s share capital, which decreased from €3,533 thousand in first-half 2022 to €322 thousand in first-half 2023.

 

The decline in R&D purchases and external expenses chiefly reflects the completion of clinical trials for the COVA and SARA programs in second-half 2022. Some residual clinical development costs were recognized in 2023, but most R&D costs in the first half of the year concerned pre-clinical work on the Company’s various programs and the transition of BIO101 production to a commercial stage.

 

1.2.2            Net loss

 

(amounts in thousands of euros)  First-half 2022   First-half 2023 
Net operating loss   (11,920)   (6,524)
Net financial expense   (478)   (1,241)
Income tax benefit (expense)   -    - 
Net loss for the period   (12,398)   (7,764)

 

The Company recognized a net financial expense of €(1,241) thousand in first-half 2023 versus €(478) thousand in first-half 2022. The decrease of €763 thousand mainly reflects the change in the fair value of convertible bonds.

 

1.3 Cash flow and financial position

 

Cash and cash equivalents amounted to €5.8 million as of June 30, 2023 versus €11.1 million as of December 31, 2022. The change over the period breaks down as follows:

 

(amounts in thousands of euros)  First-half 2023 
Net cash flow used in operating activities   (8,162)
Net cash flow from investing activities   (777)
Net cash flow from financing activities   3,691 

 

1.4 Subsequent events

 

1.4.1            Developments in R&D programs

 

Developments in R&D programs after June 30 are described in section 2.1.1.

 

1.4.2            Financing

 

On July 19, 2023, the Company finalized the terms and conditions of a $3.8 million financing transaction. The transaction involved the sale of 1,333,334 units, each consisting of one (1) American Depositary Share (“ADS”) or one (1) prefunded warrant giving the holder the right to one (1) ADS (the “Prefunded Warrants”) and one (1) warrant giving the holder the right to one (1) ADS (the “Ordinary Warrants”), at a purchase price of $2.85 per unit comprising an ADS and $2.84 per unit comprising a Prefunded Warrant. Each ADS represents the right to receive one hundred (100) new ordinary shares of the Company, with a nominal value €0.01 per share. The ADSs and Prefunded Warrants were purchased through a registered direct offering, while the Ordinary Warrants were purchased through a concurrent private placement. Each Prefunded Warrant, giving the holder the right to one (1) ADS, was subscribed at a price of $2.84 and will have an exercise price of $0.01 per ADS. The Prefunded Warrants will be exercisable immediately upon issuance and will expire ten years after their issuance. The Ordinary Warrants will have an exercise price of $3.00 per ADS, will become exercisable immediately upon issuance and will expire three years after their issuance.

 

Page 6 of 28

 

 

Half-year financial report as of June 30, 2023

 

The ADSs and Prefunded Warrants (and the underlying ADSs) (excluding the Ordinary Warrants offered in the concurrent private placement and the ADSs underlying the Ordinary Warrants) were offered and sold by the Company pursuant to a “shelf” registration statement using Form F-3 (File No. 333-271385) filed with the US Securities and Exchange Commission (SEC) on April 21, 2023 and declared effective by the SEC on May 1, 2023. The offering of the ADSs and Prefunded Warrants (and the underlying ADSs) was made exclusively by means of a prospectus, including a prospectus supplement, forming part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering were filed with the SEC.

 

The Ordinary Warrants described above were issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and, along with the ADSs underlying the Ordinary Warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the Ordinary Warrants and the ADSs underlying the Ordinary Warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

 

The issuance of the 50,500,000 new ordinary shares underlying the ADSs resulted in an immediate capital increase of €1.3 million, representing approximately 11% of the Company’s share capital and voting rights before the offering. The issue price of the ordinary shares underlying the ADSs represents a premium of 2% over the volume-weighted average price (VWAP) of the Company’s ordinary shares on the Euronext Growth Paris market during the 15 trading sessions preceding the determination of the issue price on July 18, 2023 and a discount of 21% on the VWAP when including 23% of the theoretical value of one warrant, which is €0.013 per warrant.

 

1.5 Developments and outlook

 

In the second half of 2023, the Company will pursue its value-creation strategy based on the development of its therapeutic innovations, in particular its drug candidate Sarconeos (BIO101), and anticipates the following main events:

 

·COVA program – Development of Sarconeos (BIO101) for severe forms of COVID-19 patients

 

The company will be seeking Scientific Advice from the EMA and FDA (Type B meeting) in the second half of the year on the clinical and regulatory development plan for Sarconeos (BIO101) up to the submission of a marketing authorization application for the treatment of severe forms of COVID-19.The discussions will enable Biophytis to present the available data (pre-clinical, clinical, product and industrialization) and specify the additional information to be provided as part of marketing authorization applications, in particular the design of a confirmatory Phase 3 clinical study. Biophytis will also ask the agencies about the possibility of extending the scope of its indication to viral respiratory pathologies other than COVID-19, notably influenza, based on its non-specific mechanism of action. This extension would significantly increase the number of patients eligible for treatment and optimize the commercial potential of Sarconeos (BIO101).

 

In addition, the Company is awaiting HAS authorization for its early access program in France, and is preparing for its launch in the second half of 2023 with its partner, the Intsel Chimos laboratory. It will also apply to reactivate the authorization of its early access program in Brazil in the second half of 2023. These two programs should enable the drug to be prescribed as early as this year to hospitalized patients with severe forms of COVID-19 at risk of respiratory failure and death.

 

Page 7 of 28

 

 

Half-year financial report as of June 30, 2023

 

·SARA program – Development of Sarconeos (BIO101) for sarcopenia

 

Based on the authorizations received from the Belgian and US agencies to conduct a Phase 3 study in sarcopenia, the Company will continue to actively look for partners in order to begin in 2024 the very large-scale study in a collaboration arrangement under licensing agreements with global or regional pharmaceutical companies.

 

·MYODA program – Development of Sarconeos (BIO101) for Duchenne muscular dystrophy (DMD)

 

The Company plans to finalize the preparation of a Phase 1-2 study, with the aim of enrolling the first patient in the first half of 2024.

 

·MACA program – Development of Macuneos (BIO201) for Age-related macular degeneration (AMD)

 

The Company will continue its pre-clinical development work on Macuneos (BIO201) and its backup BIO203, and prepare for clinical development its drug candidate for dry AMD (MACA program).

 

1.6 Risk factors

 

The risk factors are the same as those presented in the 2022 Annual Financial Report in Appendix 2 “Risks and uncertainties faced by the Company”.

 

1.7 Transactions between related parties

 

Transactions with related parties are the same as those presented in the 2022 Annual Financial Report in Note 20 “Related parties” of section 3 “Consolidated financial statements prepared in accordance with IFRS as of and for the year ended December 31, 2022” and in Note 19 “Related parties” of section 4 “Annual financial statements of Biophytis SA for the year ended December 31, 2022”.

 

Page 8 of 28

 

 

 

Half-year financial report as of June 30, 2023

 

2. Unaudited condensed interim consolidated financial statements under IFRS for the six-month period ended June 30, 2023

 

Statement of consolidated financial position

 

       AS OF 
(amounts in thousands of euros)  NOTES   DECEMBER 31,
2022
  

JUNE
30, 2023

 
ASSETS               
Patents and software        2,655    2,647 
Property, plant and equipment        121    101 
Property, plant and equipment – Right of use   2    463    324 
Other non-current financial assets        173    164 
Total non-current assets        3,411    3,237 
                
Other receivables   3    6,934    5,162 
Other current financial assets        590    432 
Cash and cash equivalents   4    11,053    5,782 
Total current assets        18,576    11,376 
TOTAL ASSETS        21,987    14,613 
                
                
LIABILITIES AND SHAREHOLDERS' EQUITY               
Shareholders' equity               
Share capital   6    47,660    4,268 
Premiums related to the share capital        (1,588)   8,353 
Treasury shares        (21)   (19)
Foreign currency translation adjustment        (25)   (7)
Retained earnings - attributable to owners of the parent        (23,689)   (8,153)
Net loss - attributable to owners of the parent        (24,216)   (7,806)
Shareholders' equity - attributable to owners of the parent        (1,879)   (3,322)
Non-controlling interests        (32)   (32)
Total shareholders' equity        (1,911)   (3,354)
                
Liabilities               
Employee benefit obligations   9    183    188 
Non-current financial liabilities   8    4,368    3,558 
Non-current lease liability   8    190    163 
Non-current derivative financial instruments   8    -    - 
Total non-current liabilities        4,551    3,909 
                
Current financial liabilities   8    9,933    8,935 
Current lease liability   8    280    170 
Provisions        75    - 
Trade payables   5;10.1    6,940    3,711 
Accrued taxes and employee benefits payable   10.2    1,780    904 
Current derivative financial instruments   8    13    7 
Other creditors and miscellaneous liabilities   7    328    332 
Total current liabilities        19,348    14,058 
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY        21,987    14,613 

 

Page 9 of 28

 

 

Half-year financial report as of June 30, 2023

 

Statement of consolidated operations

 

      

FOR THE SIX-MONTH PERIOD
ENDED JUNE 30,

 
(amounts in thousands of euros, except share and per share data)  NOTES   2022   2023 
Revenue        -    - 
Cost of sales        -    - 
Gross margin        -    - 
                
Research and development expenses, net   11.1    (6,867)   (3,763)
General and administrative expenses   11.2    (5,053)   (2,761)
Operating loss        (11,920)   (6,524)
                
Financial expenses        (1,492)   (795)
Financial income        (14)   143 
Change in fair value of convertible notes        1,028    (589)
Net financial expense   12    (478)   (1,241)
                
Loss before taxes        (12,398)   (7,764)
                
Income taxes        -    - 
Net loss for the period        (12,398)   (7,764)
                
Attributable to owners of the company        (12,398)   (7,764)
Non-controlling interests        -    - 
                
Basic and diluted weighted average number of shares outstanding        147,803,141    327,549,006 
Basic loss per share (€/share)   13    (0.08)   (0.02)
Diluted loss per share (€/share)   13    (0.08)   (0.02)

 

Statement of consolidated comprehensive loss

 

   FOR THE SIX-MONTH PERIOD
ENDED JUNE 30,
 
(amounts in thousands of euros)  2022   2023 
Net loss for the period   (12,398)   (7,764)
Items that will not be reclassified to profit or loss          
Remeasurements of the defined benefit liability (asset)   40    23 
Items that will be reclassified to profit or loss          
Foreign currency translation adjustment   46    18 
Other comprehensive income   86    41 
           
Total comprehensive loss   (12,312)   (7,724)
           
Attributable to owners of the company   (12,312)   (7,724)
Non-controlling interests   -    - 

 

Page 10 of 28

 

 

Half-year financial report as of June 30, 2023

 

Statement of changes in consolidated shareholders’ equity

 

(amounts in thousands of euros,

except share data)

  Notes  Share
capital –
number of
shares
   Share
capital
   Premiums
related to
the share
capital
   Accumulated
deficit
and net
loss
   Foreign
currency
translation
adjustment
   Share
based
payment
   Split
accounting impact related
to convertible
notes and
warrants attached to non-convertible
bonds
   Treasury
Shares
   Shareholders'
equity -
Attributable
to owners of
the company
   Non-controlling
interests
   Shareholders'
equity
 
As of January 1, 2022       135,953,657    27,191    27,781    (58,852)   (72)   8,942    897    (51)   5,835    (32)   5,803 
Net loss for the period       -    -    -    (12,398)   -    -    -    -    (12,398)   0    (12,398)
Other comprehensive income       -    -    -    40    46    -    -    -    86    -    86 
Total comprehensive income (loss)       -    -    -    (12,358)   46    -    -    -    (12,312)   0    (12,312)
Conversion of convertible notes       27,847,526    5,570    374    -    -    -    -    -    5,943    -    5,943 
Share capital increase       -    -    -    -    -    -    -    -    -    -    - 
Exercise of warrants       22,320    4    2    -    -    -    -    -    7    -    7 
Treasury shares movements, net       -    -    -    -    -    -    -    (3)   (3)   -    (3)
Allocation of premiums to retained earnings       -    -    (19,748)   19,748    -    -    -    -    -    -    - 
Gains and losses, net related to treasury shares       -    -    -    (29)   -    -    -    -    (29)   -    (29)
Impact of IFRS 16       -    -    -    18    -    -    -    -    18    -    18 
Equity settled share-based payments       -    -    -    -    -    3,533    -    -    3,533    -    3,533 
As of June 30, 2022       163,823,503    32,765    8,409    (51,474)   (27)   12,477    896    (54)   2,992    (32)   2,960 
As of January 1, 2023       238,297,642    47,660    (1,588)   (63,312)   (25)   14,510    896    (21)   (1,880)   (32)   (1,911)
                                                            
Net loss for the period            -    -    (7,764)   -    -    -    -    (7,764)   (0)   (7,764)
Other comprehensive income            -    -    23    18    -    -    -    41    -    41 
Total comprehensive income (loss)            -    -    (7,742)   18    -    -    -    (7,724)   (0)   (7,724)
Conversion of convertible notes (1)       83,170,323    14,724    (10,717)   -    -    -    -    -    4,007    -    4,007 
Share capital increase       103,717,811    1,037    1,265    -    -    -    -    -    2,302    -    2,302 
Costs incurred in relation to equity transactions       -    -    (339)   -    -    -    -    -    (339)   -    (339)
Exercise of warrants       1,597,355    16    (15)   -    -    -    -    -    1    -    1 
Capital decrease (2)       -    (59,169)   -    59,169    -    -    -    -    -    -    - 
Allocation of share premium (3)       -    -    19,748    (19,748)   -    -    -    2    2    -    2 
Gains and losses, net related to treasury shares       -    -    -    (13)   -    -    -    -    (13)   -    (13)
Equity settled share-based payments       -    -    -    -    -    322    -    -    322    -    322 
As of June 30, 2023       426,770,699    4,268    8,354    (31,645)   (7)   14,833    896    (19)   (3,322)   (32)   (3,354)

 

(1)The negative additional paid-in capital is due to the nominal value of the shares being higher than their actual value at the time of conversion of the bonds
(2)On April 17, 2023, the Board of Directors decided to reduce the share capital by reducing the par value of each share form €0.20 to €0.01.
(3)On April 17, 2023, the Board of Directors decided to allocate additional paid-in capital to retained earnings.

 

Page 11 of 28

 

 

Half-year financial report as of June 30, 2023

 

Statement of consolidated cash flows

 

       FOR THE SIX-MONTH PERIOD
ENDED JUNE 30,
 
(amounts in thousands of euros)  NOTES   2022   2023 
Cash flows from operating activities               
Net loss for the period        (12,398)   (7,764)
Adjustments to reconcile net loss to cash flows used in operating activities               
Amortization and depreciation of intangible and tangible assets        150    256 
Additions of provisions, net of reversals        43    (200)
Expenses associated with share-based payments   7    3,533    322 
Gross financial interest paid   12    1,219    549 
Changes in fair value of convertible notes   12    (1,028)   589 
Unwinding of conditional advances and other financial expenses        15    12 
Amortized cost of convertible notes and non-convertible bonds        169    149 
Operating cash flows before change in working capital requirements        (8,296)   (6,086)
(+) Change in working capital requirements (net of depreciation of trade receivables and inventories)        (1,965)   (2,075)
(Increase) decrease in other non-current financial assets        -    9 
(Increase) decrease in other receivables        (3,646)   2,018 
Increase (decrease) in trade payables        2,483    (3,230)
Increase (decrease) in tax and social security liabilities        (711)   (876)
Increase (decrease) in other creditors and miscellaneous liabilities        (92)   4 
                
Cash flows (used in) from operating activities        (10,261)   (8,204)
                
Cash flows used in investing activities               
Acquisition of intangible and tangible assets        (22)   (90)
Interests on investment accounts               
(Increase) decrease of other current financial assets        344    (695)
Sale of term deposit classified as other non-current financial assets        12    8 
Cash flows (used in) from investing activities        333    (777)
                
Cash flows from financing activities               
Proceeds from share capital increase   6    -    2,303 
Costs paid in relation to equity transactions   6    -    (339)
Exercise of warrants (BSA) and founders’ warrants (BSPCE)        7    - 
Proceeds of subsidies        153    - 
Proceeds of the prefinanced CIR receivables, net of guarantee deposit   3    -    1,059 
Proceeds from conditional advances        4    - 
Repayment of conditional advances        (149)   (165)
Financial interest paid        (687)   (246)
Proceeds from the issuance of non-convertible bonds and convertible notes   8    8,000    1,890 
Repayment of non-convertible bonds   8    (1,259)   (615)
Repayment of lease liabilities   8    -    (144)
Cost incurred in relation to the issuance of convertible notes and non-convertible bonds        (380)   (55)
Cash flows (used in) from financing activities        5,689    3,691 
Net effect of exchange rate changes on cash and cash equivalents        58    (24)
Decrease in cash and cash equivalents        (4,181)   (5,272)
                
Cash and cash equivalents at the beginning of the period   4    23,926    11,053 
Cash and cash equivalents at the end of the period   4    19,745    5,782 

 

Page 12 of 28

 

 

 

Half-year financial report as of June 30, 2023

 

Notes to the unaudited interim condensed consolidated financial statements

 

The following information constitutes the Notes to the condensed interim financial statements for the six-month period ended June 30, 2023 with comparative information for the year ended December 31, 2022 for balance sheet items and for the six-month period ended June 30, 2022 for income statement items.

 

The unaudited condensed consolidated interim financial statements of Biophytis, or the “Financial Statements”, have been prepared under the responsibility of management of the Company and were approved and authorized for issuance by the Company’s Board of Directors on September 27, 2023.

 

Unless otherwise indicated, the unaudited condensed consolidated interim financial statements are presented in thousands of euros. Certain amounts may be rounded for the purpose of calculating the financial information contained in the unaudited condensed interim consolidated financial statements. Consequently, the totals in certain tables may not correspond exactly to the sum of the preceding figures.

 

Biophytis and its subsidiaries are referred to hereinafter as “Biophytis,” or the “Company”.

 

Note 1: Accounting principles, rules and methods

 

1.1 Statement of compliance

 

In accordance with European regulation 16/06/2002 of July 19, 2002 on international accounting standards, the Company's unaudited condensed interim consolidated financial statements for the six months ended June 30, 2023 have been prepared in accordance with current international accounting standards, as adopted by the European Union ("IFRS") and IFRS standards as published by the IASB (International Accounting Standards Board). These standards include the International Accounting Standards (IAS/IFRS), the interpretations of the Standard Interpretations Committee (SIC) and the International Financial Reporting Interpretations Committee (IFRIC) as published by the International Accounting Standards Board (IASB) as at June 30, 2023 and applicable at that date.

 

The unaudited condensed consolidated financial statements for the six months ended June 30, 2023 have been prepared in accordance with IAS 34 - Interim Financial Reporting, as adopted by the European Union, and IFRS standards as published by the IASB (International Accounting Standards Board) which allows a selection of explanatory notes to be presented. As they are condensed financial statements, they do not include all the information required by IFRS and should be read in conjunction with the Company's annual IFRS consolidated financial statements for the year ended December 31, 2022 (the "Annual Financial Statements").

 

1.2 Going concern

 

The Board of Directors approved the Financial Statements on a going concern basis despite the loss of (7,8) million euros for the six-month period ended June 30, 2023. This analysis takes into account :

 

-Cash and cash equivalents as of June 30, 2023 amounted to 5.8 million euros; and
-The potential use of a funding line of convertible notes established in June 2021 with Atlas that could generate up to 20 million euros of additional funding (8 tranches with a nominal value of 4 million euros each, the first and the second tranches have been issued in April, June and October 2022, respectively).

 

The Company believes that the level of cash and cash equivalents, supplemented by the use of existing financing facilities, is sufficient to cover the Company's cash requirements for the next 12 months from the balance sheet date.

 

 Page 13 of 28 

 

 

Half-year financial report as of June 30, 2023

 

1.3 Accounting methods

 

The accounting principles adopted for the Financial Statements as of and for the six-month period ended June 30, 2023 are the same as for the year ended December 31, 2022 with the exception of the specific provisions for the preparation of interim financial statement.

 

Standards, amendments and interpretations published by the IASB for mandatory application from 1 January 2023

 

The main standards and amendments in force, whose application will be compulsory from January 1, 2023 within the European Union, are as follows:

 

·IFRS 17 on insurance contracts;
·Disclosure of accounting policies - Amendment to IAS 1 and IFRS Practice Statement 2;
·Definition of accounting estimates - Amendment to IAS 8; and
·Deferred tax relating to assets and liabilities arising from the same transaction - Amendment to IAS 12.

 

These standards and amendments did not have a material impact on the Company's condensed interim consolidated financial statements. At 30 June 2023, the IASB had not published any additional amendments that could have an impact on the Company's consolidated financial statements.

 

Significant standards, amendments and interpretations published by the IASB but not yet mandatory

 

No standards, amendments or interpretations which have been published by the IASB, but not yet adopted by the European Union and which are not yet applicable at June 30, 2023 could have a significant impact on the financial statements of the company.

 

1.4 Translation of the financial statements of foreign subsidiaries

 

The financial statements of entities whose functional currency is not the euro are translated as follows:

 

·assets and liabilities are converted using the closing rate of the period;
·income statement items are translated using the average rate of the period as long as it is not called into question by significant changes in rate; and
·equity items are converted using the historical rate.

 

The exchange differences arising on translation are recognized in Other Comprehensive Income. They are reclassified as profit or loss upon total or partial exit with loss of control of the entity.

 

 Page 14 of 28 

 

 

Half-year financial report as of June 30, 2023

 

The exchange rates used for the preparation of the Financial Statements are as follows:

 

 

Closing rate
AS OF

  

Average rate for the
Six-month period ended

 
EXCHANGE RATE  DECEMBER 31, 2022   JUNE 30, 2023   JUNE 30, 2022   JUNE 30, 2023 
BRL   5.6386    5.2788    5.5565    5.4827 
USD   1.0666    1.0866    1.0934    1.0807 

 

1.5 Use of judgments and estimates

 

The preparation of financial statements requires management to make reasonable estimates and assumptions based on information available at the date the financial statements are finalized. These estimates and assumptions may affect the reported amounts of assets, liabilities and expenses in the financial statements, and the disclosure of contingent assets and liabilities at the date of review of the financial statements.

 

In preparing the condensed interim consolidated financial statements, the main judgements made by management and the main assumptions used are the same as those applied in preparing the annual financial statements for the year ended December 31, 2022.

 

These estimates are based on the going concern assumption and are prepared on the basis of the information available at the time.

 

The international geopolitical and economic situation has not led to the use of any significant new estimates or judgements in the first half of 2023.

 

Note 2: Leases

 

(Amounts in thousands of euros)  12/31/2022   Increase   Decrease   06/30/2023 
Right of use   770    -    -    770 
Amortization of right of use   (307)   (139)   -    (446)
Net value of right of use   464    (139)   0    324 

 

Rights of use mainly relate to the lease of the head office and leases of laboratory equipment. These rights of use are amortized over the residual term of the contracts.

 

Note 3: Other receivables

 

(Amounts in thousands of euros)  12/31/2022   06/30/2023 
Research Tax Credit (CIR)   3,904    4,144 
Value added tax   956    647 
Prepaid expenses   1,574    152 
Trade payables – prepayments and trade debtors   488    209 
Others   12    12 
Total other receivables   6,934    5,162 

 

The French Research Tax Credit ("CIR") at June 30, 2023 includes the CIR for the year ended December 31, 2022 (€3,364 thousand) for which repayment has been requested by the Company. The CIR is estimated on the basis of expenses incurred and eligible for the tax credit. The 2022 CIR was pre-financed to the tune of 2,414 thousand euros by the Predirec Innovation 3 common securitization fund with Neftys as arranger. Consequently, the Company recorded a liability corresponding to the amount due to NEFTYS upon collection of the CIR recognized at amortized cost in accordance with IFRS 9 (see note 8) and a financial asset for the amounts taken by NEFTYS from the assigned receivables.

 

 Page 15 of 28 

 

 

Half-year financial report as of June 30, 2023

 

Note 4: Cash and cash equivalents

 

Cash and cash equivalents are broken down as follows:

 

(amounts in thousands of euros)  AS OF
DECEMBER 31,
 2022
  

AS OF

JUNE 30,

2023

 
Bank accounts   6,060    1,793 
Short-term deposits   4,993    3,989 
Total cash and cash equivalents   11,053    5,782 

 

On June 30, 2023, the Company had a term deposit of 4 million euros maturing on July 28 2023 and bearing interest at 2.02%. As this term deposit meets the requirements of IAS 7.6 and IAS 7.7, i.e. short-term, liquid investments that can be drawn down quickly, it has been classified as cash and cash equivalents.

 

Note 5: Financial assets and liabilities and impacts on consolidated statement of profit or loss

 

The Company’s financial assets and liabilities are measured as follows as of December 31, 2022 :

 

   AS OF DECEMBER 31, 2022 
           Value - Statement of financial 
   Value -       position (IFRS 9) 
   Statement of       Fair value     
   financial       through profit   Amortized 
(amounts in thousands of euros)  position   Fair value   or loss   cost 
Non-current financial assets   173    173         173 
Other receivables   6,934    6,934    -    6,934 
Other current financial assets   590    590    -    590 
Cash and cash equivalents   11,053    11,053    11,053    - 
Total financial assets   18,749    18,749    11,053    7,696 
Non-current financial liabilities   4,367    4,117    -    4,367 
Current financial liabilities   10,177    10,308    6,660    3,552 
Current derivative financial instruments   13    13    13    - 
Trade payables   6,940    6,940    -    6,940 
Tax and social liabilities   1,780    1,780    -    1,780 
Miscellaneous liabilities   328    328    -    328 
Total financial liabilities   23,640    23,485    6,673    16,967 

 

 Page 16 of 28 

 

 

Half-year financial report as of June 30, 2023

 

The Company’s financial assets and liabilities are measured as follows as of June 30, 2023 :

 

   AS OF JUNE 30, 2023 
           Value - Statement of financial 
   Value -       position (IFRS 9) 
   Statement of       Fair value     
   financial       through profit   Amortized 
(amounts in thousands of euros)  position   Fair value   or loss   cost 
Non-current financial assets   164    164    -    164 
Other receivables   5,152    5,152    -    5,152 
Other current financial assets   432    432    -    432 
Cash and cash equivalents   5,782    5,782    5,782    - 
Total financial assets   11,530    11,530    5,782    5,748 
Non-current financial liabilities   3,721    3,710    -    3,721 
Current financial liabilities   9,105    8,947    5,054    4,052 
Current derivative financial instruments   7    7    7    - 
Trade payables   3,711    3,711    -    3,711 
Tax and social liabilities   904    904    -    904 
Miscellaneous liabilities   332    332    -    968 
Total financial liabilities   17,779    17,611    5,061    13,356 

 

The impact of the Company’s financial assets and liabilities on the consolidated statement of profit or loss are as follows for the six-month period ended June 30, 2022 and 2023:

 

  

AS OF JUNE 30, 2022

   AS OF JUNE 30, 2023 
(amounts in thousands of euros)  Interest   Change in fair
value
   Interest   Change in fair
value
 
Profit or loss impact of liabilities                
Derivative financial instruments   -    1,262    -    6 
Liabilities at amortized cost: non-convertible bonds   (1,004)   -    (724)   - 
Liabilities at fair value: convertible notes   -    1,028    -    (589)
Liabilities at amortized cost: advances   (15)   -    (31)   - 

 

Note 6: Share capital

 

   AS OF
DECEMBER 31,
 2022
  

AS OF

JUNE 30,

2023

 
Share capital (in thousands of euros)   47,660    4,268 
Number of outstanding shares   238,297,642    426,770,699 
Nominal value per share (in euros)   0,20   0,01

 

During the six months ended June 30, 2023 :

 

-124 bonds held by Atlas Capital were converted into new shares generating the issue of 83,170,323 shares, representing a capital increase of €14,724 thousand and an issue premium of €(10,717) thousand (based on the fair value of the shares issued at the date of conversion).

 

-Following the exercise of warrants during the period, the share capital was increased by €101 through the issue of 5,963 new shares, with a total issue premium of €417.

 

 Page 17 of 28 

 

 

Half-year financial report as of June 30, 2023

 

-On April 17, 2023, the Board of Directors decided to reduce the Company's share capital by a total of €59.2 million, by reducing the par value of each share from €0.20 to €0.01 and by deducting this amount from retained earnings.

 

-On May 11, 2023, the Company carried out a capital increase for a net amount of €1,963 thousand (including €339 thousand in capital increase costs) by issuing 103,717,811 new ordinary shares with a par value of €0.01. This represents a capital increase of €1,037 thousand and a share premium of €926 thousand.

 

In addition, the General Meeting of April 17, 2023 decided to increase the "share premium" account by €19,748 thousand, by offsetting the "retained earnings" account.

 

Note 7: Warrants and founders’ warrants

 

BSA warrants issued to investors

 

       Number of outstanding warrants   Number of 
Type   Grant date 

As of
January 1,
2023

   Granted   Exercised   Lapsed  

As of

June 30,

2023

   shares
which can
be
subscribed
 
Warrants 2020   04/07/2020   2,469,969    -    (6,021)       2,463,948    2,463,948 
Total       2,469,969    -    (6,021)       2,463,948    2,463,948 

  

In April 2020, the Company decided to carry out a public offering of warrants. The main aim of the operation is to involve investors in the COVA program and in the Company's future development. At the end of the operation, 7,475,708 warrants were issued after the extension clause had been fully exercised. The subscription price was €0.06 per warrant. The warrants may be exercised over a period of 5 years from April 30, 2020, at an exercise price of 0.27 euro per new share. Each warrant entitles its holder to subscribe to one new ordinary share in the Company.

 

BSA warrants issued pursuant to equity-compensation plan

 

The following table summarizes the data related to the warrants issued pursuant to equity-compensation plans as well as the assumptions adopted for valuation in accordance with IFRS 2:

 

       Characteristics   Assumptions  IFRS2 Initial
valuation
(Black-
 
Type   Grant date  Number of
warrants
granted
   Maturity
date
   Exercise
price
   Volatility   Risk-free
rate
   Scholes) in
thousands of
euros
 
BSA 2021   06/17/2022   398,476   06/17/2028    0.097    63%   0.62%   17 
BSA 2022   04/14/2023   927,333   04/14/2029    0.054    74%   2.79%   12 

  

On 14 April 2023, the Company allocated 927,333 BSA2022 giving entitlement to subscribe for one new ordinary share with a par value of one euro cent (€0.01). The issue price is €0.0027 and the exercise price is €0.0544. The BSA2022 exercise period is divided into 3 tranches: 1/3 of the BSAs may be exercised immediately, 1/3 of the BSAs may be exercised 1 year after the grant date and 1/3 of the BSAs may be exercised 2 years after the grant date. No condition of presence is attached to the 2022 warrants.

 

 Page 18 of 28 

 

 

Half-year financial report as of June 30, 2023

 

Changes in the number of warrants in circulation at 30 June 2023 can be analyzed as follows:

 

            Number of outstanding warrants     Number of  
Type     Grant date  

As of
January 1,
2023

    Granted     Exercised   Lapsed    

As of
June 30,
2023

    shares which
can be
subscribed
 
BSA-2021     06/17/2022     398,476     -     -   -     398,476     398,476  
BSA 2022     04/14/2023     -     927,223     -   -     927,233     927,223  
Total           398,476     927,223     -   -     1,325,699     1,325,699  

  

BSA warrants issued to Kreos Group

 

See Note 8.2.2 Issuance of convertible and non-convertible bonds to Kreos – Contract 2021.

 

Founders’ warrants (“BSPCE”)

 

The following table summarizes the data related to BSPCE founder’s warrants issued as well as the assumptions used for valuation in accordance with IFRS 2:

  

      Characteristics    Assumptions      IFRS 2 Initial 
                                 valuation 
       Number of                         (Black-Scholes) 
       warrants   Maturity  Expected   Exercise        Risk-free    in thousands of 
Type  Grant date   granted   date  term   price    Volatility    rate    euros 
BSPCE2019-1  04/03/2020   1,333,333   03/04/2026  2 years   0.27   48.36%   -0.62%   674 
BSPCE2019-2  04/03/2020   666,667   03/04/2026  4 years   0.27   53.32%   -0.56%   356 
BSPCE2020-1  12/22/2020   999,393   22/12/2026  2 years   0.47   57.80%   -0.77%   508 
BSPCE2020-2  12/22/2020   499,696   22/12/2026  4 years   0.47   57.91%   -0.77%   284 
BSPCE2021-1  09/15/2021   2 919 415   15/09/2027  1 year   0.73   79.11%   -0.73%   677 
BSPCE2021-2  09/15/2021   1 459 707   15/09/2027  2 years   0.73   106.04%   -0.75%   595 

 

Activity for BSPCE founder’s warrants that were outstanding during the six-month period ended June 30, 2023 are summarized in the table below:

 

           Number of outstanding warrants    Number of  
                                   shares 
          As of                   As of    which can 
          January 1,                   June 30,    be 
Type    Grant date    2023    Granted    Exercised    Lapsed    2023    subscribed 
BSPCE2019-1    04/03/2020    831,298    -    -    (76,469)   754,828    754,828 
BSPCE2019-2    04/03/2020    590,542    -    -    (38,235)   552,007    552,007 
BSPCE2020-1    12/22/2020    640,803    -    -    (155,809)   484,993    484,993 
BSPCE2020-2    12/22/2020    353,643    -    -    (77,905)   275,738    275,738 
BSPCE2021-1    09/15/2021    2,581,393    -    -    (591,387)   1,990,007    1,990,007 
BSPCE2021-2    09/15/2021    1,290,697    -    -    (295,693)   995,003    995,003 
Total         6,288,073    -    -    (1,238,498)   5,052,576    5,052,576 

 

 Page 19 of 28 

 

 

Half-year financial report as of June 30, 2023

 

Free shares

  

                  IFRS 2 Initial 
       Characteristics    Assumptions    valuation (Black- 
       Number of                        Scholes) in 
       free shares     Maturity     Exercise         Risk free -    thousands of  
Type  Grant date   granted    date    price    Volatility    rate    euros 
Free shares 2021-2  04/25/2021   1,591,334    N/A    N/A    N/A    N/A    271 
Free shares 2022  04/14/2023   18,904,158    N/A    N/A    N/A    N/A    775 
Total      20,495,492                        1,046 

 

Activity for the unvested free shares that were outstanding during the six-month period ended June 30, 2023 are summarized in the table below:

 

        Number of unvested free shares 
       Unvested free                   Unvested free 
       shares as of                   shares as of 
Type  Grant date   January 1, 2023    Granted    Vested    Cancelled    June 30, 2023 
Free shares 2021-2  04/25/2021   1,591,334    -    (1,591,334)   -    - 
Free shares 2022  04/14/2023   -    18,904,158    -    -    18,904,158 
Total      1,591,334    18,904,158    -    -    18,904,158 

 

On April 14, 2023, the Company granted 18,904,158 free shares allowing beneficiaries to receive one free ordinary share in the Company. Free shares 2022s are subject to a one-year presence condition and a one-year holding period.

 

Stock-based compensation expense recognized for the periods presented

 

(amounts in thousands of euros)

 

     SIX-MONTH PERIOD ENDED JUNE 30, 2022    SIX-MONTH PERIOD ENDED JUNE 30, 2023 
         Cumulative                   Cumulative           
    Probabilistic      expenses -         Cumulative     Probabilistic      expenses -         Cumulative  
    cost of the      beginning     Expense for    expense to    cost of the      beginning     Expense for     expense to 
Type   plan     of period     the period     date    plan    of period    the period    date 
BSA2021   17    -    17    17    17    17    -    17 
BSA2022   -    -    -    -    12    -    12    12 
BSPCE2019--1   646    572    74    646    646    646    -    646 
BSPCE2019-2   297    111    56    166    293    209    28    237 
BSPCE2020-1   433    341    50    390    438    438    -    438 
BSPCE2020-2   197    43    32    75    165    101    2    104 
BSPCE2021-1   639    431    145    576    640    640    -    640 
BSPCE2021-2   503    77    121    198    401    328    31    359 
Free shares2020   2,301    1,184    565    1,749    2,301    2,301    -    2,301 
Free shares2021-1   4,907    1,447    2,425    3,872    4,907    4,907    -    4,907 
Free shares2021-2   271    -    49    49    271    186    86    271 
Free shares2022   -    -    -    -    775    -    163    163 
Total   10,211    4,206    3,533    7,739    10,865    9,772    322    10,094 

 

 Page 20 of 28 

 

 

 

Half-year financial report as of June 30, 2023

 

Note 8 : Borrowings and financial liabilities

 

(amounts in thousands of euros)  AS OF
DECEMBER 31,
 2022
   AS OF
JUNE 30,
2023
 
Conditional advances   664    559 
Non-convertible bonds   1,721    1,122 
Convertible bonds   1,792    1,877 
Non-current lease obligations   190    163 
Non-current financial liabilities   4,367    3,721 
 Non-current derivative financial instruments   -    - 
Conditional advances   418    371 
Non-convertible bonds   1,017    1,131 
Convertible notes   6,462    5,054 
Financial liabilities related to the prefinancing of a portion of the research tax credit receivables   2,035    2,314 
Current lease obligations   280    170 
Accrued interest payable   -    66 
Current financial liabilities   10,213    9,104 
 Current derivative financial instruments   13    7 

 

Breakdown of financial debt at 30 June 2023 by maturity, at balance sheet value :

 

   AS OF
JUNE 30,
   Current   Non-current 
(amounts in thousands of euros)  2023   < 1 year   1 to 5 years   > 5 years 
Conditional advances   929    371    559    - 
Non-convertible bonds   2,253    1,131    1,122    - 
Convertible notes   6,931    5,054    1,877    - 
Lease liabilities   333    170    163    - 
Financial liabilities related to the prefinancing of a portion of the research tax credit receivables   2,314    2,314    -    - 
Accrued interest payable   66    66    -    - 
Total financial liabilities   12,825    9,104    3,721    - 
Derivative financial instruments   7    7    -    - 

  

8.1 Conditional advances

 

(amounts in thousands of euros)  BPI – BIO101   AFM - Téléthon   BPI – BIO201   Total 
As of January 1, 2023   324    385    373    1,083 
(+) Proceeds from conditional advances   -    -    -    - 
(-) Repayment   (165)   -    -    (165)
Subsidies   -    -    -    - 
Financial expenses   6    4    3    13 
Others   -    (2)   -    (2)
As of June 30, 2023   165    387    377    929 

 

Page 21 of 28

 

 

Half-year financial report as of June 30, 2023

 

Breakdown of conditional advances by maturity in repayment value

 

(amounts in thousands of euros)  BPI – BIO 101   AFM - Téléthon   BPI – BIO 201   Total 
As of June 30, 2023   165    387    377    929 
<1 year   165    193    14    373 
1 year to 5 year   -    193    363    566 
>5 years   -    -    -    - 

 

8.2 Convertible notes and non-convertible bonds

 

8.2.1 Issuance of convertible notes to ATLAS – 2021 Atlas Contract

 

(Amounts in thousands of euros)  ATLAS
ORNANE -
2021
 
As of January 1, 2023   6 462 
(+) Gross proceeds (1)   2000 
(+/-) Change in fair value of financial liabilities   595 
(-) Conversion   (4 003)
As of June 30, 2023   5 054 

 

(1) Net proceeds of €1,890 thousand (subscription price of 96% of the par value of €2,000 thousand) less expenses of €30 thousand.

 

In June 2021, the Company signed a new convertible bond financing of up to 32 million euros with Atlas Special Opportunities LLC (the “2021 Atlas Contract”) to continue the development of Sarconeos (BIO 101) through the issuance of multiple convertible notes. This three-year contract provides for the issue of a maximum of 1,280 bonds with an option to be exchanged for cash and/or converted into new or existing shares (ORNANE) in eight successive tranches of €4 million each.

 

The agreement imposes certain operational and financial restrictions. These covenants may limit the ability of the parent company and its subsidiaries, in certain circumstances, to, among other things, incur additional debt, create or incur liens, sell or transfer assets and pay dividends. These covenants were met at 30 June 2023. The agreement also contains certain customary covenants and events of default, including in the event of a change of control.

 

Main characteristics of the ORNANE ATLAS 2021

 

The ORNANE will have a par value of 25 000 euros. They will not bear interest and will have a 24-month maturity from issuance. The holder of ORNANE may request at any time to convert them into shares during their maturity period, and the Company shall have the right to redeem the ORNANE in cash. In case of cash redemption, the amount reimbursed will be limited to 110% of the principal. At the end of the maturity period, and in the case where the ORNANE would not have been redeemed either in cash or in new or existing shares, the holder will have the obligation to convert the ORNANE.

 

The holder can ask to convert the ORNANE at any time at the conversion parity determined by the following formula: N = CA / CP, where

 

·“N” is the number of shares yielded by the conversion,

 

·“CA” is the par value of the ORNANEs (i.e., 25,000 euros each),

 

·“CP” is the conversion price (i.e., the lowest stock market price observed over the 10 days preceding the conversion request).

 

Page 22 of 28

 

 

Half-year financial report as of June 30, 2023

 

On the day of the conversion request, the Company may redeem the ORNANE in cash using the following formula: V = (CA/CP) * CPr, where

 

·“V” is the amount to be redeemed to the holder.

 

·“CPr” is the revised price.

 

The revised price is the lowest price between (i) the volume weighted average price over the 10 trading days preceding the date on which conversion is requested and (ii) P*1.10

 

Accounting treatment:

 

The Company determined that it could not reliably estimate separately the fair value of the conversion option embedded in the convertible bonds, and therefore concluded that the entire hybrid contract should be measured at fair value through profit or loss until settlement. Fair value is measured using a binomial valuation model. As the expected maturity of the bonds is short, the "Day one loss" (including the redemption premium and/or the issue premium) is immediately recognized in the income statement.

 

In the first half of 2023, the Company issued 80 ORNANE bonds (second half of the third tranche) for a total of 2 million euros. Issue premiums were paid for 80 thousand euros and transaction costs for 30 thousand euros. In addition, the whole of Tranche 1, i.e. 160 ORNANE bonds, and 136 ORNANE bonds from Tranche 2 were converted.

 

The tables below summarizes the key inputs to measure the fair value of the convertible notes:

 

   Tranche 2 
ATLAS 2021 

At issuance date

(June 28, 2022)

   June 30, 2023 
Number of outstanding convertible notes   160    24 
Conversion price   0.10   0.02
Volatility   70%   85%
Risk-free rate   1.82%   3.78%
Value of the convertible notes (in thousands of €)   3,840    659 

 

   Tranche 3 
ATLAS 2021 

At issuance date

(October 28, 2022)

   June 30, 2023 
Number of outstanding convertible notes   160    160 
Conversion price   0.04   0.02
Volatility   70%   85%
Risk-free rate   2.81%   3.88%
Value of the convertible notes (in thousands of €)   3,840    4,394 

 

Page 23 of 28

 

 

Half-year financial report as of June 30, 2023

 

8.2.2 Issuance of convertible and non-convertible bonds to Kreos – Contract 2021

 

(financial liabilities in thousand
euros)
  KREOS 2021
Non-Convert.
Tranches
   KREOS 2021
Convert.
Tranches
   KREOS 2021
Bifurcated
derivatives
   KREOS 2021
BSA 2018
Buyback
   KREOS 2021
day one
gain
   Total 
As of December 31, 2022 (As restated)   2,687    1,792    13    (48)   53    4,497 
(+/-) Fair value of derivative instruments (1)   -    -    (6)   -    -    (6)
(+/-) Amortized cost   149    85    -    -    (19)   215 
(-) Repayment   (615)   -    -    -    -    (615)
As of June 30, 2023   2,219    1,876    7    (48)   33    4,089 

 

(1)Decrease in value per option from 0,00584€ on December 31, 2022, to 0,00327€ on June 30, 2023

 

On November 19, 2021, the Company entered into a "venture loan agreement" with KREOS in lieu of a framework agreement organizing the issue of a bond loan for an amount of up to €10 million through the issue of 7,75 million euros in non-convertible bonds ("Straight bonds"), the issue of 2.25 million euros in convertible bonds ("Convertible bonds"), and the issue of Biophytis share subscription warrants. The issuance of the first tranche is conditioned to the subscription of the warrants previously mentioned. The four-tranche loan agreement was partially drawn down by the Company in fiscal 2021 for a total amount of 6.2 million euros.

 

The non-convertible bonds bear interest at an annual rate of 10% and have been repaid in cash in 36 monthly installments since April 1, 2022.

 

The convertible bonds bear interest at an annual rate of 9.5%. The Company will redeem them for their principal amount no later than March 31, 2025, unless they are previously converted into shares, at the option of Kreos Capital, at a fixed conversion price of €0.648.

 

The Company has also issued to Kreos Capital 2,218,293 warrants giving the right to subscribe to new ordinary shares in the Company, on the basis of one share for one warrant. The warrants may be exercised over a period of 7 years from the date of issue. The exercise price of the warrants has been set at €0.56. If, in the event of exercise of the warrants, the market price (VWAP) of Biophytis shares on the exercise date is lower than the exercise price, Kreos will receive a cash payment from the Company based on a formula taking into account the difference between these two prices.

 

The loan agreement pledges the Company's goodwill, bank account balances and intellectual property rights to Kreos. It also imposes certain operational and financial restrictions. These covenants may limit the ability of the Company and its subsidiaries, in certain circumstances, to, among other things, incur additional debt, sell or transfer assets and pay dividends. The agreement also contains certain customary covenants and events of default, including in the event of a change of control.

 

Accounting treatment of KREOS 2021 hybrid financing

 

The analysis of the characteristics of the hybrid contract according to the IFRS9 and IAS32 criteria led to the need to recognize the conversion options, as well as the BSAs, as derivative instruments separate from the host contract (no equity component insofar as these options do not in all circumstances lead to the delivery of a fixed number of shares, for a fixed price).

 

Page 24 of 28

 

 

Half-year financial report as of June 30, 2023

 

The amount of cash of €5.5 million, received on November 19, 2021 (excluding transaction costs) corresponds to the estimated fair value of the instruments put in place on the date the funds were drawn: financial debt for tranches A and B for €(4.3) million (convertible and non-convertible), liability derivatives for premiums received on options sold for €(1.2) million (€464 thousand for conversion options and €710 thousand for BSAs issued), and financial compensation of €48 thousand for the 2018 BSAs bought back by Biophytis from KREOS. Regarding the third tranche (C) of the straight bond issued in December 2021 for €677 thousand (excluding transaction costs), as the drawdown conditions were fulfilled outside the framework of the contract, the company analyzed the drawdown of the third tranche (C) as a new loan contract, with Kreos Capital VI UK. As such, the third tranche (C) is recognized for its fair value on the balance sheet, estimated on the basis of the financing rate deducted from the Kreos VI financing. The entry value of the liabilities of the Tranche C leads to the recognition of a day one Gain of €98 thousand. Given the unobservable nature of the market rate, the day one gain is deferred on the Company’s balance sheet and recorded as financial liabilities.

 

In accordance with IAS 32, the redemption value of the 2018 BSAs was recognized for €48 thousand as a reduction in equity, consistent with the treatment applied to the BSAs issued in 2018.

 

The financial debt components are accounted for according to the principles of amortized cost, based on an average effective interest rate of 26.37% for the non-convertible tranches, and 22.85% for the convertible tranches. Derivative instruments are valued at their Fair Value on the balance sheet, with changes in fair value recorded in the income statement. Fair value is estimated using a binomial valuation model for convertible bonds, and a Black & Scholes valuation model for BSAs.

 

The table below presents the valuations of the conversion options:

 

Fair value of bifurcated conversion options of tranches
A and B (maturing March 2025)
  At issuance date
(11/19/2021)
   12/31/22   06/30/23 
Number of obligations in circulation   2,250,000    2,250,000    2,250,000 
Number of shares that can be subscribed   2,250,000    2,250,000    2,250,000 
Share price   0.451   0.046   0.021
Exercise price   0.648   0.648   0.648
Volatility over a 12 months period   85%   65%   85%
Risk-free rate   -%   3.39%   3.9%
Credit spread   23.14%   23.14%   23.14%
Fair value of the derivative instrument (in K€)   (464)   -    - 
Change in the fair value of the derivative instrument (in K€)        536    - 

 

The table below shows the valuations of the BSA 2021 attached to the KREOS contract:

 

BSA – KREOS 2021

 

Derivative instruments

  At issuance date
 (19/11/2021)
   12/31/2022   06/30/2023 
Number of BSAs in circulation   2,218,293    2,218,293    2,218,293 
Exercise price per share   0.56   0.56   0.56
Maturity   7 years    5.88 years    5.38 years 
Volatility   85%   65%   85%
Risk-free rate   -    3.24%   3.9%
Fair value of BSA 2021 issued in favor of KREOS (in K€)   (710)   (13)   (7)
Change in the fair value of the derivative instrument (in K€)        775    6 

 

(1) Refer to note 2.7 “Restatement of Previously Issued Financial Statements”

 

Page 25 of 28

 

 

Half-year financial report as of June 30, 2023

 

Note 9: Employee benefit obligation

 

Employee benefits consist of the provision for retirement indemnities. In estimating this provision, there have been no significant changes in the assumptions used compared with those presented in note 13 to the consolidated financial statements for the year ended December 31, 2022.

 

Note 10: Current liabilities

 

10.1 Trade payables

 

   AS OF 
(amounts in thousands of euros)  DECEMBER 31,
2022
   JUNE 30,
2023
 
Research and development suppliers   5,250    2,237 
General and administrative suppliers   1,690    1,473 
Total trade payables   6,940    3,710 

 

The change in trade accounts payable is consistent with the reduction in R&D expenditure, linked in particular to the finalization of clinical studies under the COVA and SARA programs in the second half of 2022.

 

10.2 Tax and social liabilities

 

   AS OF 
(amounts in thousands of euros)  DECEMBER 31,
2022
   JUNE 30,
2023
 
Personnel expenses   855    440 
Social security expenses   831    399 
Other taxes   94    65 
Total tax and social liabilities   1,780    904 

 

The decrease in social security liabilities is due to the reduction in the provision for performance-related bonus in the period under review, and to the reduction in the employer's contribution in relation to bonus shares granted by the Company and acquired by beneficiaries.

 

Note 11: Details of expenses and products by function

 

11.1 Research and development expenses

 

   FOR THE SIX-MONTH PERIOD
ENDED JUNE 30,
 
(amounts in thousands of euros)  2022   2023 
Personnel expenses   (2,950)   (1,443)
Purchases and external expenses   (6,435)   (3,099)
Other   (99)   (143)
Research and development expenses   (9,485)   (4,685)
Research tax credit   2,614    922 
Subsidies   4    - 
Research tax credit and subsidies   2,618    - 
Research and development expenses, net   (6,867)   (3,763)

 

Page 26 of 28

 

 

Half-year financial report as of June 30, 2023

 

11.2 General and administrative expenses

 

   FOR THE SIX-MONTH PERIOD
ENDED JUNE 30,
 
(amounts in thousands of euros)  2022   2023 
Personnel expenses   (2,682)   (962)
Purchases and external expenses   (2,235)   (1,685)
Other   (136)   (114)
General and administrative expenses   (5,053)   (2,761)

 

Total personnel costs amounted to 2,406 thousand euros at June 30, 2023, compared with 5,633 thousand euros at June 30, 2022. This sharp reduction stems mainly from expenses relating to share-based payments, which amounted to 322 thousand euros in 2023 compared with 3,533 thousand euros in 2022 (see Note 7). The Company's average headcount is stable at 26 in the first quarter of 2023, compared with 24 in the first quarter of 2022.

 

External expenses fell sharply, particularly in R&D activities. This change reflects the completion of clinical trials for the COVA and SARA programs in the second half of 2022. Residual costs related to clinical development were booked in 2023, but the bulk of R&D expenditure over the half-year concerned various preclinical work on the Company's different programs, and work relating to the production of BIO101

 

Note 12: Net financial income and expenses

 

   FOR THE SIX-MONTH PERIOD
ENDED JUNE 30,
 
(amounts in thousands of euros)  2022   2023 
Financial interest and amortized cost of the non-convertible bonds (1)   (1,004)   (724)
Changes in fair value of convertible notes (1)   1,028    (589)
Accrual of provision in relation with Negma litigation   (75)   - 
Other financial expenses   (33)   (36)
Transaction costs related to the issuance of convertible notes   (380)   - 
Other financial income   (14)   143 
Foreign exchange gains (losses)   -    (34)
Total net financial expense   (478)   (1,241)

 

(1) Refer to Note 12.2 Convertible notes and non-convertible bonds

 

Note 13: Earnings per share

 

   FOR THE SIX-MONTH PERIOD
ENDED JUNE 30,
 
   2022   2023 
Net income attributable to common shareholders   (12,398)   (7,764)
Number of shares issued   238,297,642    426,770,699 
Number of treasury shares   54,310    19,129 
Number of shares outstanding (excluding treasury stock)   238,243,332    426,751,570 
Share warrants   3,795,678    3,789,647 
Warrants for business creator shares   6,288,076    5,052,576 
Shares from conversion of convertible bonds   288,472,222    198,214,189 
Bonus shares   -    18,904,159 
Number of shares issued and potential (excluding treasury stock)   536,799,308    653,397,309 
           
Weighted average number of shares outstanding (excluding treasury stock)   147,803,141    327,549,006 
Earnings per share in euros   -0.08    -0.02 
Potential dilutive securities resulting from the exercise of warrants, conversion of bonds or acquisition of bonus shares   286,325,709    214,421,435 
Weighed average number of outstanding and potential shares (excluding treasury stock)   434,128,850    541,970,441 
Diluted earnings per share in euros (*)   (0.08)   (0.02)

 

(*) The impact of dilution is not presented for 2022 and 2023, as it is accretive due to negative earnings.

 

Page 27 of 28

 

 

Half-year financial report as of June 30, 2023

 

Note 14: Related Parties

 

No significant new transactions were entered into with the Company's related parties during the first six months of fiscal 2023.

 

Note 15: Off-balance-sheet commitments

 

The off-balance-sheet commitments have not changed significantly since December 31, 2022.

 

Note 16: Subsequent events

 

There are no events after June 30, 2023 likely to have an impact on the financial statements.

 

Page 28 of 28

 


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