Full Press Release Details
A joint-stock company (soci t anonyme) with a share capital of 517,528.07 euros
Registered office: 50, rue de Dijon, 21121 Daix, France
Dijon Trade and Companies Register 537 530 255
INTERIM FINANCIAL REPORT
FOR THE SIX MONTHS ENDED JUNE 30, 2023
| 1. | Interim Financial Report | 3 |
| 1.1. | General overview of activities | 3 |
| 1.2. | Significant events in the first half of 2023 | 5 |
| 1.3. | Recent events and prospects | 6 |
| 1.4. | Risk factors | 8 |
| 1.5. | Earnings analysis | 11 |
| 1.6. | Analysis of the financial situation | 16 |
| 2. | Cash flow and equity | 18 |
| 2.1. | Cash and cash equivalents | 18 |
| 2.2. | Cash flow analysis | 20 |
| 2.3. | Anticipated sources of funds | 22 |
| 3. | Unaudited interim condensed consolidated financial statements | 24 |
| 4. | Other information | 58 |
| 4.1. | Table of delegations | 58 |
In this half-yearly report (the Interim Financial Report ), and unless otherwise specified, the terms Inventiva or the Company are taken to mean the company Inventiva S.A. with its registered office at 50, rue de Dijon, 21121 Daix, France, and which is listed with the Dijon Trade and Companies Register under number 537 530 255 and its subsidiary, 100% owned, Inventiva Inc. with its registered office at 10-34 44th Dr, Long Island City, 11101 New York, USA, created in January 2021.
Certain terms used in this Interim Financial Report are defined in the Company's Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 30, 2023 and in the 2022 Universal Registration Document's glossary.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This document contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our management's beliefs and assumptions and on information currently available to our management. All statements other than present and historical facts and conditions contained in this document, including statements regarding our future results of operations and financial positions, business strategy, plans and our objectives for future operations, are forward-looking statements. When used in this document, the words anticipate, believe, can, could, estimate, expect, intend, is designed to, may, might, plan, will, would, potential, predict, objective, should, or the negative of these and similar expressions identify forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
We encourage you to read and carefully consider all of the risk factors disclosed in Item 3.D Risk Factors of our Annual Report and Section 1.4 hereof, for a more complete understanding of the risks and uncertainties material to our business, including important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this document will prove to be accurate. Furthermore, if our
forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. These forward-looking statements represent our plans, objectives, estimates, expectations and intentions only as of the date of this filing. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
You should read this document and the documents that we reference herein completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
Market and competitive position
This Interim Financial Report also contains information about the Company's activities and the markets on which it operates. This information comes from studies or surveys carried out internally or externally. Other information contained in this Interim Financial Report is available to the general public. The Company considers that all of this information is reliable, but it has not been verified by an independent expert. The Company cannot guarantee that a third party using different methods to gather, analyze or calculate market data would obtain the same results.
Certain figures (including data expressed in thousands or millions of euros or dollars) and the percentages presented in this Interim Financial Report have been rounded up or down. Accordingly, totals given may vary slightly from those obtained by adding the exact (unrounded) values of those same figures.
Certain figures are given in thousands or millions of euros and are indicated as thousand or million respectively in this Interim Financial Report.
1.Interim Financial Report
1.1. General overview of activities
Since the Company's founding, most of its resources have gone into research and development ( R&D ), particularly in order to develop- lanifibranor, its most advanced drug candidate, for patients suffering from non-alcoholic steatohepatitis ( NASH ), a chronic and progressive liver disease for which there is currently no approved treatment. The positive results of the Company's NATIVE Phase IIb were announced in June 2020 and Breakthrough Therapy and Fast Track designations were granted by the U.S. Food and Drug Administration ( FDA ). The Company has initiated the pivotal Phase III clinical trial of lanifibranor in NASH ( NATiV3 ) in the second half of 2021 and a combination trial with lanifibranor and empagliflozin in patients with NASH and Type 2 Diabetes ( T2D ).The last patient first visit for the ongoing NATiV3 Phase III clinical trial evaluating lanifibranor in patients with NASH is targeted by the end of the second half of 2023, subject to the continuing implementation of measures to accelerate the enrollment rate. (see section 1.2 - Significant events in the first half of 2023 below on the development of NATiV3 and partnership with Sino Biopharm). The delay the Company has faced has been primarily due to a higher than originally projected screen failure rate resulting in slower than anticipated enrollment rate.
In addition, on September 21, 2022, the Company entered into a license and collaboration agreement with Chia Tai Tianqing Pharmaceutical Group, Co., LTD ( CTTQ ), a Sino Biopharm group company, to develop, import, manufacture, commercialize and market lanifibranor, subject to regulatory approval, for the treatment of NASH and potentially other metabolic diseases, in China, Hong Kong, Macau and Taiwan (Greater China). In May 2023, CTTQ received Investigational New Drug ( IND ) approval from the Chinese National Medical Products Administration ( NMPA ) to initiate the clinical development in mainland China of lanifibranor in NASH. Sino Biopharm will participate in the ongoing NATiV3 Phase III trial which, if positive, is expected to support a potential filing of a new drug application in China. In parallel, CTTQ will conduct a Phase I clinical pharmacology study. The license and collaboration agreement with CTTQ provides for two short-term milestone payments together amounting to a total of $5 million. The first milestone payment of $2 million was received on July 19, 2023, following CTTQ receiving the NMPA's IND approval. The second potential milestone payment under the agreement with CTTQ for $3 million would be due upon enrolment of a first patient in the registrational study of licensed product for first indication in mainland China.
On June 13, 2023, the Company announced positive topline results from the investigator-initiated Phase II clinical trial evaluating lanifibranor in patients with T2D and nonalcoholic fatty liver disease ( NAFLD ).
The study achieved the primary efficacy endpoint demonstrating a 44% reduction of hepatic fat measured by proton magnetic resonance spectroscopy (1H-MRS) following 24 weeks of treatment in patients with NAFLD.
The study also demonstrated that a significantly higher proportion of patients achieved a greater than 30% liver triglyceride reduction as well as NAFLD resolution with lanifibranor compared to placebo.
In addition, the study demonstrated a significant effect on a series of secondary endpoints and amelioration of the adipose tissue dysfunction with a robust increase in plasma adiponectin. The treatment with lanifibranor 800mg/once daily for 24 weeks was well tolerated, with no safety concerns reported.
The Company experienced slower than predicted site activation, screening and enrollment due to negative impacts from the COVID-19 pandemic mainly during the years 2020 and 2021 and the Company was unable to conduct clinical trial activities at sites originally located in Ukraine and Russia. The Company has implemented and is planning further measures designed to accelerate enrollment and reduce screen failures in the NATiV3 trial, and additional sites have been identified to help compensate for the inability to use sites in Ukraine and Russia. As of the date of this report, 409 clinical sites have been activated. The publication of the topline results of the part 1 of NATiV3 is now targeted for the second half of 2025, subject to the continuing implementation of measures to accelerate the enrollment rate.
INTERIM FINANCIAL REPORT FOR THE SIX MONTHS ENDED JUNE 30, 2023 || 1. Interim Financial Report
The Company's pipeline also includes odiparcil for the treatment of patients with mucopolysaccharidosis type VI ( MPS VI ), a group of rare genetic diseases. The Company believes the potential for an efficient development pathway for odiparcil for the treatment of MPS VI exists based on FDA feedback and continues to review potential options to further development of odiparcil for the treatment of MPS VI, which may include pursuing a partnership.
To a lesser extent, in the development of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Hippo signaling pathway program aims to disrupt the interaction between yes-associated protein, or YAP, and transcription enhancer associated domain transcription factors, or TEAD, an interaction that plays a key role in oncogenic and fibrotic processes. In xenograft and orthotopic models of malignant pleural mesothelioma, or MPM, the Company observed that YAP-TEAD inhibition was associated with reduced tumor growth and is in the process of selecting a development candidate for the Hippo program, which the Company anticipates entering pre-clinical development in 2023.
The Company previously had a strategic collaboration with AbbVie Inc. ( AbbVie ) in the area of autoimmune diseases. As previously disclosed, AbbVie announced in October 2022, that they decided to stop the development of cedirogant (formerly ABBV-157). The Company's and AbbVie's joint efforts led to the discovery of cedirogant, which was being evaluated by AbbVie in a Phase II clinical trial for the treatment of moderate to severe psoriasis at the time of AbbVie's decision to discontinue further clinical development.
These research and development activities are presented in further detail in Item 4.B Business Overview of the Company's Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 30, 2023 and Chapter 1 Business activities and markets of the 2022 Universal Registration Document and Chapter 3 Business overview of the URD amendment 2022 in connection with the August 2023 financing. Changes in research and development costs are detailed in section 1.5.2 Operating expenses below.
INTERIM FINANCIAL REPORT FOR THE SIX MONTHS ENDED JUNE 30, 2023 || 1. Interim Financial Report
1.2. Significant events in the first half of 2023
1.2.1.Operations and product portfolio
Changes in the clinical development of lanifibranor
On January 4, 2023, the Company announced changes to the clinical development of lanifibranor intended to benefit the overall clinical program by reducing the number of biopsies and the trial duration, eventually offering all patients in the trial access to lanifibranor treatment by allowing them to enter into a new active treatment extension study, and potentially expanding the addressable patient population beyond patients with F2 and F3 fibrosis to patients with NASH and compensated cirrhosis through an additional Phase III trial.
Service contract with Avant Sant
On February 21, 2023, the Company entered into a study service agreement with Avant Sant , a contract research organization ( CRO ) based in Mexico, in connection with the NATiV3 clinical trial. Pursuant to the terms of the agreement, the CRO is to randomize 120 patients in 10 clinical sites in Mexico by December 31, 2023. The Company estimates that it will pay Avant Sant a total amount up to 14.7 million over the period from February 22, 2023, the effective date of the contract, until the second half of 2027.
On May 22, 2023, CTTQ received IND approval from the NMPA to initiate the clinical development in mainland China of lanifibranor in NASH. Sino Biopharm will participate in the ongoing NATiV3 Phase III trial which, if positive, is expected to support a potential filing of a new drug application in China. In parallel, CTTQ will conduct a Phase I clinical pharmacology study.
The license and collaboration agreement with CTTQ provides for two short-term milestone payments together amounting to a total of $5 million. The first milestone payment of $1.9 million after deducting the withholding tax of $0.2 million1 was received on July 19, 2023 following CTTQ receiving the NMPA's IND approval.
The second potential milestone payment under the agreement with CTTQ for $3 million would be due upon enrolment of a first patient in the registrational study of licensed product for first indication in mainland China.
Results of Phase II clinical trial evaluating lanifibranor in patients with T2D and NAFLD
On June 13, 2023, the Company announced positive topline results from the investigator-initiated Phase II clinical trial evaluating lanifibranor in patients with T2D and NAFLD.
The study achieved the primary efficacy endpoint demonstrating a 44% reduction of hepatic fat measured by proton magnetic resonance spectroscopy (1H-MRS) following 24 weeks of treatment in patients with nonalcoholic fatty liver disease.
The study also demonstrated a significantly higher proportion of patients achieved a greater than 30% liver triglyceride reduction as well as NAFLD resolution with lanifibranor compared to placebo.
In addition, the study demonstrated a significant effect on a series of secondary endpoints and amelioration of the adipose tissue dysfunction with a robust increase in plasma adiponectin. The treatment with lanifibranor 800mg/once daily for 24 weeks was well tolerated, with no safety concerns reported.
1 The Company invoiced 1.9 million on May 22, 2023 (corresponds to the milestone payment of 1.8 million euros, and an additional invoicing of 0.1 million) and received on July 19, 2023, 1.7 million after deduction of withholding tax for 0.2 million. The exchange rate on the invoice date was 1.082 dollar for one euro.
INTERIM FINANCIAL REPORT FOR THE SIX MONTHS ENDED JUNE 30, 2023 || 1. Interim Financial Report
Amendment to the CRO Contract with Pharmaceutical Research Associates B.V.
On June 26, 2023, in connection with the NATiV3 Phase III trial in NASH, the Company entered into a new amendment to the April 2021 agreement with retroactive effect in January 2021 with pharmaceutical Research Associates Groupe B.V ( PRA ) (see Note 6.1 - Commitments related to operational activities). The amendment makes updates to provisions relating to study information following changes to the trial protocol. The commitment to PRA amounts to 207.0 million euros, with a bonus or malus capped at 2.4 million euro, amended from the previous commitment to PRA, which amounted to 223.8 million euros, with a bonus or malus capped at 3.4 million euro.
Share-based payments
Granting of new plans
The Board of Directors decided on May 25, 2023 to grant the following shares:
The plans are described in note 4.8 Shareholders' Equity of section 3. Unaudited interim condensed consolidated financial statement.
1.3. Recent events and prospects
1.3.1.Operations and product portfolio
On July 27, 2023, the Company announced the recruitment for its pivotal Phase III trial NATiV3 of lanifibranor in non-cirrhotic NASH continues with 389 sites activated in 23 countries, as of July 27, 2023, and that the previously announced revised study design which limits the duration of the trial to 120 weeks instead of up to 7 years, reduces the number of biopsies from three to two, and includes a 48-week active treatment extension study, has been approved in 16 countries and approximately 70% of activated sites are currently operating under the revised design as of July 27, 2023. This new patient friendly design is improving the patient enrollment rate which has doubled since implementation in sites where the revised design has been in place for more than 3 months. In addition, the screen failure rate has been improving since September 2022.
In China, CTTQ, after receiving the IND approval from the NMPA on May 22 2023, has opted to join NATiV3 and the Company is working with CTTQ to activate 50 sites in mainland China and 2 sites in Hong Kong.
As of July 27, 2023, the patients randomized and those having successfully met all recruitment criteria is approximately 50% of the planned enrollment in NATiV3 and the last patient first visit is targeted by the end of the second half of 2023.
As of July 27, 2023, the baseline characteristics of the patients enrolled in NATiV3 so far are aligned with expectations and the baseline characteristics of patients enrolled in the NATIVE Phase IIb trial. The main difference is a higher percentage of patients with T2D thus far in NATiV3 compared to NATIVE Phase IIb (58% vs 42% respectively). The effect size of lanifibranor therapy over placebo in the Phase IIb clinical trial on the composite endpoint NASH resolution and fibrosis improvement', which corresponds to the primary efficacy endpoint in the Phase III NATiV3 clinical trial, was higher in patients with T2D versus patients who did not have diabetes: 21% and 26% for lanifibranor 800 and 1200 mg/day, respectively, in patients with T2D versus 7% and 22%, respectively, in patients who did not have diabetes.
INTERIM FINANCIAL REPORT FOR THE SIX MONTHS ENDED JUNE 30, 2023 || 1. Interim Financial Report
Two Data and Safety Monitoring Board ( DSMB ) meetings have taken place, both with recommendations to continue the study without any modification to the protocol. Of note the safety profile to date is consistent with what was observed in previous clinical trials with lanifibranor.
In October 2021, the Company announced the design of LEGEND, a Phase IIa clinical trial combining lanifibranor with empagliflozin, an SGTL2 inhibitor, in patients with type 2 diabetes and non-cirrhotic NASH. For this trial, screening and randomization of the 63 patients began in July 2022 as planned. Recruitment of patients has been slower than expected and topline results are now targeted for the end of the first quarter of 2024 compared to the second half of 2023 as previously announced.
The Company also announced the positive conclusion of the renal insufficiency study, required for regulatory submission, demonstrating that the pharmacokinetics of lanifibranor are not affected in patients with renal insufficiency. Should the NATiV3 study be successful, the Company plans to proceed with the submission of an NDA seeking accelerated approval in the United States and a conditional marketing authorization application in the European Union, to enable the commercialization of lanifibranor.
[ Licensing agreement with Hepalys
On September 20, 2023; the Company and Hepalys Pharma, Inc. announced the execution of an exclusive licensing agreement to develop and commercialize lanifibranor in Japan and South Korea.
Hepalys Pharma, Inc. is a new company created by Catalys Pacific, incorporated in Japan. In parallel of the incorporation of Hepalys Pharma, the Company has the option to acquire 30% of the shares of Hepalys Pharma that can be exercised within the 30 days of the effective date of the licensing agreement. In addition, under the terms of this agreement, the Company has the option to acquire the outstanding shares of Hepalys Pharma at a pre-agreed multiple of post-money valuation under certain conditions and has a right of first refusal if Hepalys Pharma, Inc. receives an offer to sell the license and rights related to lanifibranor.
Under the terms of this licensing agreement, the Company will receive a $10 million upfront payment from Hepalys Pharma and will be eligible to receive up to $231 million in milestone payments if certain clinical, regulatory and commercial conditions are met. Subject to regulatory approval, the Company has the right to receive tiered royalties from mid double digits to low twenties based on net sales of lanifibranor in Japan and South Korea.
This agreement is expected to accelerate the time to market of lanifibranor in Japan and South Korea if regulatory approvals are obtained. According to external publications, both countries are major markets, with up to 2.7% of and up to 5.2% of Japanese and South Koreans, respectively, suffering from NASH, including about 15% of South Korean patients with significant fibrosis. Hepalys Pharma, Inc. is expected to start the clinical development of lanifibranor by conducting two phase I studies in Japanese patients and healthy volunteers. It is anticipated that these studies would support, if positive, the initiation of a dedicated pivotal trial in Japanese and Korean patients with NASH, which is planned to start once the results of NATiV3, the pivotal phase III trial currently conducted by the Company, are available. Hepalys Pharma, Inc. will be responsible for conducting and financing all development trials in Japan and South Korea needed to file for a new drug application in these territories.
[ Key expected milestones
INTERIM FINANCIAL REPORT FOR THE SIX MONTHS ENDED JUNE 30, 2023 || 1. Interim Financial Report
Capital increase and issuance of royalty certificates
On August 31, 2023, the Company announced a financing of approximately 35.7 million (gross) consisting of two transactions: (i) the August 2023 Share Issuance consisting of the issuance of 9,618,638 newly-issued ordinary shares with a nominal value of 0.01 per share, at a subscription price of 3.18 per share and aggregate gross proceeds of 30.6 million and (ii) the Royalty Certificate Issuance for an amount of 5.1 million.
The price of the new shares was decided by the Board of Directors on August 30, 2023, under the authority granted by the sixth resolution of the General Shareholders' Meeting of January 25, 2023, and is equal to the weighted average of the prices quoted for the last ten trading sessions on the Euronext Paris regulated market, calculated from the day before the price was set (i. i.e. August 29, 28, 25, 24, 23, 22, 21, 18, 17 and 16, 2023, i.e. 3.34), less a discount of around 5%, i.e. 3.18.
The price of the new shares represents a discount of 0.22% to the volume-weighted average price of the Company's shares during the trading session preceding the setting of the 3.19 issue price.
Settlement and delivery of the new shares took place on September 5, 2023.
The royalty certificates issued pursuant to a decision by the Board of Directors on August 30, 2023, in accordance with the provisions of article L. 228-36-A of the French Commercial Code, to certain investors who participated in the capital increase and grant holders the right to receive annual royalties equivalent to 2% of future net sales of lanifibranor, if any, beginning in the fiscal year following the start of the sales of the Product following the granting of the market authorization (Autorisation de mise sur le march ) for the Product in (i) the United States or (ii) the countries of the European Union or (iii) the United Kingdom, whichever occurs first, capped at 92.1 million. The Company intends to use the proceeds primarily to fund the Phase III evaluation of lanifibranor for NASH treatment. These certificates do not provide additional financial rights beyond royalties and do not apply to products other than lanifibranor. They have a 15-year term and do not provide for an accelerated repayment in case of change of control. The Company may at any time repurchase in full the royalty certificates by paying an amount equal to (i) the global cap of 92.1 million minus any royalties paid prior to such repurchase or (ii) a price to be agreed between the Company and the holders of the royalty certificates. Settlement of the August 2023 Share Issuance and Royalty Certificate Issuance occurred on September 5, 2023. The certificates will not be listed on any stock exchange.
The Company's business faces significant risks. You should carefully consider all of the information set forth in this document and in the Company's other filings with the United States Securities and Exchange Commission, or the SEC, including the risk factors which the Company faces and which are faced by the Company's industry described in Chapter 2 of the Company's 2022 Universal Registration Document Part I, Item 1A. Risk Factors of the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2022, in addition to the following risk factors. Our business, financial condition or results of operations could be materially adversely affected by any of these risks.
Please refer to chapter 2.1 of the Universal Registration Document 2022 and as amended in Section 2 of the amendment to the universal document as filed with the AMF under number D.23-183-A01 on August 31, 2023 (the Amendment to the Universal Registration Document 2022 ), which are incorporated herein by reference.
INTERIM FINANCIAL REPORT FOR THE SIX MONTHS ENDED JUNE 30, 2023 || 1. Interim Financial Report
The risk factor in the 2022 Universal Registration Document amended in the context of the Amendment to the 2022 Universal Registration Document is as follows:
Liquidity risk: the Company believes that it will be able to finance its activities until the beginning of the second quarter of 2024, and there is substantial doubt regarding our ability to continue as a going concern.
As of 30 June 2023, the Company had cash and cash equivalents of EUR 31.2 million, a short-term deposit of EUR 0.05 million and a long-term deposit of EUR 9.3 million, compared with EUR 86.7 million, EUR 1.0 million and EUR 0.7 million respectively as of December 31, 2022.
As of the date of this document, following the August 2023 Share Issuance and the Royalty Certificate Issuance, together amounting to 35.7 million, and the CTTQ milestone net payment of 1.7 million received in July 2023 (as detailed in section 1.2 - Significant events in the first half of 2023 of this report), the Company believes, taking into account its current cost structure and forecast expenditure commitments, that it will have sufficient net working capital to meet its current obligations until the beginning of the second quarter of 2024. This estimate does not include (i) the second tranche of the 25 million loan granted by the European Investment Bank (the EIB Financing ) in accordance with the terms of the financing agreement entered into with the Company on May 16, 2022, which is subject to the achievement of conditions precedent (see Note 4.9 Financial debt of the section 3. - Unaudited interim condensed consolidated financial statements) (ii) nor the upfront payment of $10 million under the licensing agreement with Hepalys Pharma, Inc.
Following receipt of the second tranche of the EIB Financing, the Hepalys upfront payment of $10 million (as defined in section 1.3.1 Operations and product portfolio of this document), and CTTQ milestone payment of $3 million (as defined in section 1.2 Significant events in the first half of 2023 of this document), the Company believes that it will then have sufficient net working capital to meet its current obligations until the beginning of the third quarter of 2024. This estimate is based on the Company's current business plan and does not take into account any milestone payments that may be received or paid by the Company or any other expenses related to the development of odiparcil or resulting from any acquisition of a license or of a product candidate, technology or any other development pursued by the Company.
Accordingly, our current cash position will not be sufficient to cover operating needs for at least the next 12 months. These events and conditions indicate that a material uncertainty exists that may cast significant doubt on our ability to continue as a going concern and, therefore, we may be unable to realize our assets and discharge our liabilities in the normal course of business.
This period may be shortened in the event of a significant increase, beyond the Company's expectations, in expenditure relating to the development programs, or if they progress more quickly than expected. The Company may have based itself on incorrect assumptions and may have to use its resources sooner than expected.
The Company believes that it will need to raise additional financing in the future. In particular, the financing of the Company's strategy and, in particular, its Phase III study, the results of part 1 of which are expected in the second half of 2025, will require additional financing, in particular through additional capital increases, which may result in significant dilution. The need for and pursuit of additional financing could divert the Company's management from its day-to-day activities, which could affect the development and marketing, where appropriate, of its drug candidates.
The Company expects to seek additional funds through:
Global macroeconomic conditions or disruptions and volatility in the US and global financial markets linked in particular to geopolitical events that continue to impact the markets (including Russia's invasion of Ukraine) could affect the Company's ability to obtain new financing.
INTERIM FINANCIAL REPORT FOR THE SIX MONTHS ENDED JUNE 30, 2023 || 1. Interim Financial Report
The implementation and terms of any new financing will depend on factors, particularly economic and market factors, over which the Company has no control. Future financing could take the form of financial debt, which would affect the Company's financial structure, or a capital increase, which would result in shareholder dilution, or another strategic transaction, such as a partnership. Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and, if approved, commercialize our product candidates.
In addition, the Company cannot guarantee that it will be able to obtain the necessary financing, through any of the foregoing measures or otherwise, to meet its needs or to obtain funds at acceptable terms and conditions, on a timely basis, or at all.
If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any approved product or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could impair our growth prospects. The perception that we may be unable to continue as a going concern may impede our ability to pursue any potential strategic opportunities or operate our business. Ultimately, if we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements.
INTERIM FINANCIAL REPORT FOR THE SIX MONTHS ENDED JUNE 30, 2023 || 1. Interim Financial Report
1.5. Earnings analysis
1.5.1.Revenue and other income
| Operating income | First-half | First-half | ||
| In thousands of euros | 2023 | 2022 | ||
| Revenue | 1,901 | 67 | ||
| Total revenue | 1,901 | 67 | ||
| CIR research tax credit | 3,631 | 3,210 | ||
| Subsidies | 3 | 6 | ||
| Other | 1,087 | 109 | ||
| Other income | 4,721 | 3,325 | ||
| Total revenue and other income | 6,622 | 3,392 |
The Company invoiced CTTQ for $2.1 million on May 22, 2023 (the total invoice corresponds to the milestone payment of $2 million following the IND approval from the NMPA, and an additional billing of $0.1 million).
Other income increased by 1.4 million, or 42%, compared to the first half of 2022. This increase is due to the higher French Research tax credits (Credits d'imp t recherche or CIR ) and other research tax credits resulting mainly from the increase in research and development activities for lanifibranor for the treatment of NASH in the first half of 2023.