Immatics N.V. annual report, Q4 FY2021

Immatics N.V. — FY2021 Form 20-F

Reporting period: Fiscal year ended December 31, 2021; this is an annual report, not a standalone fourth-quarter report. Immatics is a clinical-stage biopharmaceutical company developing T-cell receptor-based cancer immunotherapies. It had no products approved for sale and no product-sales revenue. Financial statements are prepared under IFRS in euros.

Key financial results

MetricFY2021FY2020
Collaboration revenue€34.8 million€31.3 million
Research and development expenses€87.6 million€67.1 million
General and administrative expenses€33.8 million€34.2 million
Operating loss€86.3 million€69.7 million
Net loss€93.3 million€211.8 million
Basic and diluted loss per share€1.48€4.40
Cash used in operating activities€81.8 million€85.6 million
Cash and cash equivalents at year-end€133.0 million€207.5 million

Revenue increased 11%, while R&D spending rose 31%, reflecting expanded clinical activity, manufacturing preparation and headcount. The operating loss widened by €16.6 million. Net loss narrowed largely because FY2020 included a €152.8 million non-cash share-listing expense related to the ARYA merger; FY2021 instead included a €11.0 million non-cash expense from revaluing warrant liabilities. No income tax expense was recorded.

At December 31, 2021, current assets were €152.2 million and current liabilities €95.1 million. Total assets were €174.6 million; shareholders’ equity was €24.1 million. The company reported €9.9 million of lease liabilities and €27.9 million of warrant liabilities; the filing does not identify material conventional borrowings. Total liabilities were €150.6 million. Cash, cash equivalents and other financial assets totaled €145.1 million, including €12.1 million of bonds. Management said these resources, together with the subsequent BMS upfront payment, were expected to fund operations for at least 12 months.

Business developments and material changes

  • Immatics reported interim Phase 1 IMA203 data at an October 5, 2021 cutoff: 16 patients were evaluable for efficacy; 15 had disease control, 8 had objective responses, and 3 partial responses were confirmed at subsequent scans. Results are early, from a small, open-label dose-escalation study, and are not evidence of approval or established efficacy.
  • IMA201 and IMA202 had treated 12 patients by the September 17, 2021 cutoff. Eight showed disease control and six tumor shrinkage, with no objective responses reported at cutoff. Both trials continued dose escalation.
  • In December 2021, Immatics signed a worldwide IMA401 license, development and commercialization agreement with Bristol Myers Squibb (BMS): $150 million upfront, received in February 2022, up to $770 million in potential milestones and tiered double-digit royalties. Because a required review was not complete at year-end, no upfront-related revenue was recognized in FY2021. Immatics agreed to fund the first Phase 1a trial and retained certain U.S. co-funding and co-promotion options.
  • The Amgen collaboration ended in 2021; Immatics recognized its remaining €10.2 million deferred revenue balance during the year and expects no further milestone or royalty payments under that collaboration. Genmab and GSK collaborations continued.
  • Immatics ended 2021 with 347 full-time employees, up from the prior year, and continued investment in its clinical programs and technology platforms.

Outlook, risks and unusual items

  • Management expects continued operating losses and higher R&D spending as it advances clinical and preclinical programs. It stated that funding covered at least the next 12 months, including the $150 million BMS payment received after year-end; no profitability guidance or revenue forecast was provided.
  • Planned development included IMA203 expansion cohorts, including combination and next-generation IMA203CD8 arms; IMA401 clinical development planned for the first half of 2022; IMA402 Phase 1 initiation targeted for 2023; and an IMA204 IND/CTA submission targeted for 2022. These are plans, not assured outcomes.
  • Key risks include clinical and regulatory uncertainty, patient recruitment and HLA/target eligibility constraints, potential serious treatment toxicities, complex personalized-cell manufacturing and reliance on third-party manufacturers, competition, and the need for future financing. COVID-19 could disrupt trials or supply, although management reported no material impact to date.
  • FY2021 operating cash outflow was €81.8 million. The company’s €100 million at-the-market offering program had produced no sales as of December 31, 2021. Contractual obligations included €10.3 million of lease liabilities, €4.7 million of other lease commitments and €1.7 million of CRO commitments.
  • The company reported that previously identified material weaknesses in internal control over financial reporting had been remediated during 2021; management concluded controls were effective at year-end. The auditor did not provide an internal-control attestation.
  • Potentially unusual accounting and presentation items include the non-cash 2020 share-listing expense, warrant-liability fair-value changes, and a correction to the presentation of investment purchases and maturities in prior-period cash-flow statements. The company said the correction did not change total investing cash flow or require amendment of previously filed statements.

Important facts for investors to verify

  • Review the complete audited IFRS statements and notes, especially the cash-flow presentation correction, deferred collaboration revenue and warrant-liability valuation.
  • Track actual cash use and runway, including the February 2022 BMS receipt, subsequent trial spending and any ATM or other financing activity.
  • Assess final and updated IMA203 efficacy and safety data, including response durability and results from larger cohorts; distinguish confirmed responses from interim or unconfirmed results.
  • Verify progress, timing and funding responsibilities for IMA401, IMA402, IMA204 and the IMA203 expansion cohorts, as well as any changes to stated development plans.
  • Monitor collaboration execution and potential milestone or royalty receipts; these are contingent and no collaboration milestones or royalties were recognized in the reported periods.