Inventiva S.A. — FY2023 Form 20-F
Reporting period: Fiscal year ended December 31, 2023; this is an annual report, not a standalone Q4 filing. Financial statements are presented in euros under IFRS as issued by the IASB. The filing was signed April 3, 2024.
Business context
Inventiva is a clinical-stage biopharmaceutical company with no approved products or product-sales revenue. Its lead clinical candidate is lanifibranor, being developed for NASH; odiparcil development is suspended while the company considers partnering options. The company’s prospects depend heavily on lanifibranor and its ability to secure additional funding.
Key financial metrics
| Metric (€ millions, except per-share data) | FY2023 | FY2022 |
|---|---|---|
| Revenue | 17.5 | 12.2 |
| Other income, mainly French research tax credits | 5.7 | 6.6 |
| Research and development expense | 110.0 | 60.5 |
| Operating loss | 102.7 | 57.1 |
| Net loss | 110.4 | 54.3 |
| Basic and diluted loss per share | €2.43 | €1.31 |
| Net cash used in operating activities | 81.6 | 44.9 |
| Cash and cash equivalents at year-end | 26.9 | 86.7 |
Revenue rose 43%, principally from the Hepalys Japan/South Korea license and CTTQ milestones. FY2023 revenue included €12.7 million recognized for Hepalys, comprising its upfront payment and the fair value of an option-related non-cash consideration, and €4.6 million from CTTQ. No product sales were recorded. Gross margin is not meaningful for this clinical-stage business.
R&D expense increased 82%, mainly due to lanifibranor’s NATiV3 Phase III trial. Net financial results swung to a €5.1 million loss from €2.8 million income, reflecting financing costs, foreign-exchange movements and warrant fair-value changes; the company also recorded a €2.0 million share of loss from its Hepalys investment.
At December 31, total assets were €69.6 million, total liabilities €101.6 million and shareholders’ equity negative €32.0 million. Current assets of €48.2 million were below current liabilities of €50.2 million. Reported total debt was €54.1 million, including bank borrowings, lease liabilities, EIB warrant-related derivatives and royalty-certificate liabilities. The balance sheet also included a €9.0 million long-term deposit accessible on 31 days’ notice.
Cash declined €60.3 million during FY2023. Investing activities used €7.7 million, including deposits, while financing activities provided €29.1 million. The company raised €30.6 million gross from issuing 9.6 million shares and €5.1 million from royalty certificates, partly offset by debt and lease repayments.
Material changes versus FY2022
- Net loss more than doubled, from €54.3 million to €110.4 million, as R&D spending rose sharply.
- Operating cash use increased from €44.9 million to €81.6 million, and year-end cash fell from €86.7 million to €26.9 million.
- Shares outstanding increased from 42.1 million to 52.1 million, principally following the September 2023 share issuance.
- Revenue increased from €12.2 million to €17.5 million, reflecting new Hepalys consideration and CTTQ milestone payments; these are collaboration-related, not product-sales revenue.
Outlook, risks and unusual items
- Going concern and funding: Management estimated available resources would fund operations only until the beginning of Q3 2024. It estimated needing about €100 million for the following 12 months and €175–200 million in additional funding through NATiV3 topline results targeted for H1 2026. The auditor highlighted substantial doubt about the company’s ability to continue as a going concern. These estimates depend on financing, costs and potential partner payments; funding is not assured.
- Financing after year-end: Inventiva drew the second €25 million EIB tranche on January 18, 2024, bearing 7% capitalized annual interest and repayable in January 2027. EIB warrants and future financing may dilute shareholders; the ATM program allowed up to $58 million in ADS sales through August 2, 2024.
- Clinical and regulatory risk: A treatment-related SUSAR involving elevated liver aminotransferases was reported in NATiV3 in Q1 2024. Screening and randomization were voluntarily paused, with new exclusions and increased liver monitoring; the pause was lifted March 7, 2024, but the effect on enrollment and timing remained uncertain. The company targeted topline results in H1 2026 and an NDA submission in H2 2026. Approval is not assured, and the SUSAR could prompt further studies, restrictions or safety warnings.
- Trial results and competition: The filing reported positive Phase II LEGEND interim results, including HbA1c reductions of 1.14% with lanifibranor and 1.59% with the combination, versus a 0.26% increase with placebo. Recruitment was stopped as planned; the company did not expect further study of the combination. Madrigal’s Rezdiffra received FDA approval in March 2024, increasing competitive and patient-enrollment pressure.
- Partnerships and obligations: CTTQ and Hepalys may generate future milestones and royalties, but payments depend on development, approval and sales. The 2023 royalty certificates entitle holders to 2% of qualifying future lanifibranor sales, subject to a €92.1 million cap. CRO/CMO commitments were reported at approximately €279 million through 2029, including about €90 million scheduled for 2024; these commitments are not equivalent to current debt.
- Other exposures: Management cited geopolitical disruption, trial delays, foreign-exchange exposure, inflation and vendor cost increases of 5–10% in 2023. No material litigation was reported. Management assessed disclosure controls and internal control over financial reporting as effective at year-end; the auditor did not provide an internal-control attestation.
Important facts for investors to verify
- Current cash, deposits and actual runway after the January 2024 EIB draw, compared with the stated funding need and going-concern uncertainty.
- Whether planned financing was secured, and its terms, dilution, repayment obligations or impact on future lanifibranor economics.
- NATiV3 enrollment recovery, safety updates, regulatory feedback and whether the H1 2026 topline and H2 2026 NDA targets remain achievable.
- Reconciliation of the €54.1 million reported total debt to borrowings, leases, warrant derivatives and royalty certificates, as well as the timing and terms of CRO/CMO commitments.
- Progress and contractual economics of CTTQ and Hepalys programs, including milestone conditions, funding responsibilities and any royalties or other payments actually received.