Inventiva S.A. — FY2022 Form 20-F
Reporting period: Fiscal year ended December 31, 2022; filed March 30, 2023. This is an annual report, not a standalone Q4 report. Financial statements are audited and prepared under IFRS in euros. Inventiva is a clinical-stage biopharmaceutical company with no approved products or product-sales revenue.
Key financial metrics
| Metric | FY2022 / Dec. 31, 2022 | Comparison |
|---|---|---|
| Revenue | €12.2 million | €4.2 million in 2021 |
| Other income, mainly research tax credits | €6.6 million | €4.3 million in 2021 |
| Research and development expense | €60.5 million | €48.5 million in 2021 |
| Operating loss | €57.1 million | €52.1 million in 2021 |
| Net loss | €54.3 million | €49.6 million in 2021; €33.6 million in 2020 |
| Net loss per share | €1.31 | €1.27 in 2021 |
| Net cash used in operating activities | €44.9 million | €47.6 million in 2021 |
| Cash and cash equivalents | €86.7 million | €86.6 million in 2021 |
| Total debt, including lease liabilities and EIB derivatives | €44.4 million | €10.1 million in 2021 |
| Shareholders’ equity | €45.5 million | €88.9 million in 2021 |
FY2022 revenue primarily reflects the CTTQ Greater China license agreement. Revenue remains partnership-based; the company reported no product-sales revenue. R&D spending rose chiefly with the lanifibranor Phase III NATiV3 trial and the launch of the LEGEND study. The company reported €116.0 million of total assets and €30.7 million of current liabilities at year-end. No dividend is anticipated in the foreseeable future.
Material changes versus prior period
- Revenue increased by €8.0 million, mainly from the CTTQ agreement; 2021 revenue had primarily included a €4.0 million cedirogant milestone from AbbVie.
- R&D expenses increased 25% to €60.5 million, with lanifibranor trial expenses rising to €40.3 million.
- Net loss widened to €54.3 million from €49.6 million. Operating cash use improved to €44.9 million from €47.6 million.
- Financing activities provided €37.3 million, including the €25 million first EIB loan tranche, €5.3 million of French bank loans and net ATM proceeds. Year-end cash was broadly unchanged.
- Total debt increased substantially, reflecting EIB financing and related derivative accounting, new bank loans, and FibroScan equipment leases.
Outlook, commentary and risks
- Funding and going concern: Management estimated cash would fund planned activities only through Q4 2023 and said approximately €20 million of additional funding would be needed to cover needs through March 2024. The auditor highlighted substantial doubt about the company’s ability to continue as a going concern. Management’s plans include ATM sales, additional financing, strategic transactions and a possible second €25 million EIB tranche; none is assured.
- Lanifibranor: In January 2023, the company amended the NATiV3 Phase III plan, reducing planned biopsy burden and the patient participation period and replacing the originally planned trial component with a separate outcomes trial in patients with compensated cirrhosis. Topline results for NATiV3 Part 1 are targeted for the second half of 2025, subject to enrollment and execution. The FDA had not objected to the amendments but had advised continuing NATiV3 as previously planned during prior consultation; approval is not assured.
- Other trials and pipeline: LEGEND, a Phase IIa lanifibranor/empagliflozin combination study, began enrolling in 2022, with results expected in the second half of 2023. Odiparcil development remains suspended pending options or a partner. AbbVie discontinued cedirogant in October 2022, ending that collaboration.
- CTTQ agreement: CTTQ paid an upfront amount; further development and commercial milestones and royalties depend on future achievements, regulatory approval and sales. CTTQ will fund trials in Greater China.
- Principal risks: clinical and regulatory failure or delay, slower-than-planned NATiV3 enrollment, competition in NASH, dependence on lanifibranor and third-party manufacturers/CROs, and the need for further financing. COVID-19 effects and the Russia-Ukraine conflict affected trial operations. The company also reported vendor price increases of 5–10% in 2022.
- Commitments: Disclosed contractual obligations totaled €274.4 million, including €230.5 million of CRO/CMO purchase obligations, largely associated with clinical programs. The filing identifies these as off-balance-sheet commitments; actual payments may differ.
Investor facts to verify
- Whether Inventiva secured enough financing to extend its runway beyond the stated Q4 2023 estimate, and whether it met the conditions for the second EIB tranche.
- Current NATiV3 enrollment, timing and cost forecasts, and whether the amended trial design remains acceptable to regulators.
- Results of the LEGEND trial and the timing and findings of NATiV3, against the filing’s stated targets.
- Whether CTTQ advances lanifibranor in Greater China and whether any milestone or royalty conditions are achieved.
- The reconciliation and future cash impact of debt, EIB warrants and derivatives, and the substantial CRO/CMO commitments.