Inventiva S.A. — FY 2021 Form 20-F
Reporting period: Fiscal year ended December 31, 2021; this is an annual report, not a standalone fourth-quarter filing. The consolidated financial statements are prepared under IFRS and presented in euros. Inventiva is a French clinical-stage biopharmaceutical company with no approved products and no product-sale revenue. Its lead candidate is lanifibranor for NASH.
Financial performance and position
| Metric | FY 2021 | FY 2020 |
|---|---|---|
| Revenue | €4.2 million | €0.4 million |
| Other income, mainly French research tax credits | €4.3 million | €4.9 million |
| Research and development expense | €48.5 million | €23.7 million |
| General and administrative expense | €11.2 million | €8.5 million |
| Operating loss | €52.1 million | €29.7 million |
| Net financial income (expense) | €2.8 million income | €3.9 million expense |
| Net loss | €49.6 million | €33.6 million |
| Net cash used in operating activities | €47.6 million | €30.6 million |
Revenue included a €4.0 million AbbVie milestone for cedirogant’s Phase IIb trial, recognized in 2021 and received in January 2022. There was no product revenue. Product margins are therefore not meaningful; the filing does not present a meaningful product gross margin.
At year-end, cash and cash equivalents were €86.6 million and short-term deposits were €8.8 million. Total debt was €10.1 million, principally French State-guaranteed loans; €1.2 million was current and €8.8 million long-term. Shareholders’ equity was €88.9 million. Outstanding ordinary shares numbered 40,873,551.
Changes versus the prior year
- Revenue increased by €3.8 million, primarily from the cedirogant milestone; it remains collaboration-based rather than product-based.
- R&D expense more than doubled, primarily reflecting the launch of lanifibranor’s Phase III NATiV3 trial. Lanifibranor-related research, preclinical and clinical trial expense rose to €31.3 million from €7.1 million.
- Operating cash use increased by €17.0 million as development spending accelerated. Net loss widened by €16.0 million.
- Net financial results improved to income of €2.8 million from expense of €3.9 million, mainly due to foreign-exchange gains on U.S.-dollar balances, partly offset by losses and the settlement of currency forwards.
- Cash and cash equivalents declined from €105.7 million to €86.6 million. The company raised €25.4 million net through its at-the-market offering in 2021.
Outlook, risks and notable items
- Runway and financing: Management estimated available resources would fund operating expenses and capital expenditure through Q1 2023, incorporating year-end cash and deposits, the €4.0 million AbbVie payment received in January 2022, and an expected €4.4 million CIR reimbursement. The estimate depends on the business plan and excludes certain potential development or acquisition spending. Management expects to need substantial additional funding.
- Lanifibranor trial: NATiV3 began in September 2021. Part 1 targets approximately 900 patients and a 72-week histology analysis; topline results were expected in H2 2024. The longer trial is designed to continue in approximately 2,000 patients to assess clinical outcomes. The timeline and any accelerated U.S. or conditional EU approval depend on trial results and regulatory decisions.
- Geopolitical and operational risk: NATiV3 includes sites in Ukraine, Russia and other Eastern European countries. The invasion of Ukraine and related sanctions may disrupt enrollment, trial conduct, supply chains or timelines. COVID-19 had limited reported impact to date, but had delayed recruitment in a separate NAFLD study.
- Pipeline prioritization: Inventiva suspended MPS-related R&D, including odiparcil development, while evaluating options that may include a partner. AbbVie leads cedirogant development and began its Phase IIb psoriasis trial in November 2021. Inventiva remains eligible for future milestones and royalties under the partnership.
- Contract commitments: CRO/CMO agreements for clinical and manufacturing work represented approximately €236.8 million of commitments at year-end, extending to 2028. These commitments are not equivalent to debt and may vary with contractual terms and future events.
- Tax matters: The filing describes ongoing payroll-tax discussions for 2016–2017, with €1.2 million claimed by the authorities and no year-end accounting impact reported. Earlier CIR disputes resulted in payments and adjustments; further tax-authority review remains a risk.
- Currency exposure: The company held substantial U.S.-dollar balances and had no foreign-exchange hedges in place at year-end. FY 2021 included €5.4 million of foreign-exchange gains and €1.8 million of foreign-exchange losses.
- Cybersecurity: A November 2021 email-server vulnerability was exploited. The company reported that investigations found only its email system was affected and no personal or proprietary data was exposed; it voluntarily notified the French data-protection authority.
- Controls and audit: KPMG issued an unqualified audit opinion on the IFRS financial statements. Management concluded disclosure controls and internal control over financial reporting were effective as of year-end; the filing did not include an auditor attestation on internal controls because of the company’s emerging-growth-company status.
Investor facts to verify
- Progress, enrollment and site exposure of NATiV3, and whether the expected H2 2024 Part 1 results timeline remains achievable.
- Cash burn, actual CIR reimbursements and milestone receipts, and financing needs relative to the stated Q1 2023 runway estimate.
- Future ATM or other fundraising activity, remaining capacity and potential shareholder dilution.
- Expected spending and cancellation or adjustment terms for the €236.8 million CRO/CMO commitments.
- Resolution and cash impact of the remaining payroll-tax and research-credit disputes.
- Any material developments following the reported cybersecurity incident or changes in foreign-exchange exposure.