Cellectis S.A. — FY2021 Form 20-F
Reporting period: Year ended December 31, 2021. This is an annual report, not a standalone fourth-quarter filing. Financial statements are consolidated, prepared under IFRS, and presented in U.S. dollars. Cellectis develops gene-edited cell therapies; its majority-owned subsidiary Calyxt operates in plant-based synthetic biology.
Financial performance and liquidity
| Metric | FY2021 | FY2020 |
|---|---|---|
| Revenue | $57.3 million | $73.9 million |
| Other income | $9.8 million | $8.5 million |
| Operating loss | $130.7 million | $85.4 million |
| Net loss | $125.1 million | $97.5 million |
| Net loss attributable to Cellectis shareholders | $114.2 million | $81.1 million |
| Basic and diluted loss per share | $2.55 | $1.91 |
| Research and development expense | $129.0 million | $87.0 million |
| Cash and cash equivalents | $185.6 million | $241.1 million |
| Current financial assets | $0.5 million | $27.1 million |
| Total assets | $382.1 million | $469.5 million |
| Total shareholders’ equity | $236.5 million | $308.8 million |
- Revenue declined 22.5%, mainly because FY2020 included a $27.6 million Servier upfront payment and $19.4 million of previously deferred Servier payments recognized following a 2020 agreement amendment. FY2021 collaboration revenue included $10.0 million of Allogene milestones and a $20.0 million Cytovia license consideration recorded as a receivable.
- Reported cost of revenue was $31.4 million. Gross margin, calculated as revenue less cost of revenue, was approximately 45% versus 51% in FY2020. Operating and net margins were approximately negative 228% and negative 218%, respectively.
- Operating cash outflow was $104.6 million, compared with $80.3 million in FY2020. Investing activities provided $7.3 million, largely reflecting a $27.0 million net change in financial assets, while financing activities provided $47.5 million, including $44.6 million net proceeds from Cellectis’s ATM offering. Cash and cash equivalents decreased by $55.5 million during the year.
- At year-end, lease debts were $79.9 million and other financial liabilities were $22.4 million, including the state-guaranteed loan and New York leasehold-improvement loan. The filing reports $139.7 million of total financial liabilities, trade payables, and other current liabilities combined.
- Calyxt generated $26.9 million in revenue and incurred a $28.4 million net loss in FY2021. Its operating cash use was $18.8 million; year-end cash, cash equivalents, and restricted cash totaled $14.4 million.
Material changes and business developments
- Consolidated operating loss widened by $45.2 million year over year as R&D spending rose 48% to $129.0 million, principally from higher therapeutic-program staffing, consumables, and subcontracting.
- Calyxt’s lower cost of revenue and expenses partly offset the higher Therapeutics costs. Its soybean product-line wind-down was completed in late 2021; it shifted strategic focus toward synthetic-biology solutions and BioFactory production.
- Cellectis began production of a clinical product batch at its Raleigh manufacturing facility in 2021. Its Paris facility produces certain raw and starting materials. The company cautions that it has limited experience operating and scaling in-house pharmaceutical manufacturing.
- The FDA placed Allogene’s AlloCAR T trials on clinical hold in October 2021 after a chromosomal abnormality was detected in one patient. The FDA lifted the hold in January 2022; Allogene reported that its investigation found the abnormality unrelated to TALEN editing or its manufacturing process and without clinical significance.
- After year-end, Calyxt completed an offering that raised approximately $10.0 million net on February 23, 2022. Cellectis’s ownership was reported at 56.1% after the offering, and could fall below 50% if warrants are exercised.
Outlook, commentary, and risks
- Cellectis expects significant losses and cash use to continue as it advances clinical programs, develops manufacturing capacity, and funds research. Management estimated that Cellectis Therapeutics’ cash and current financial assets, expected collaboration receipts, and government funding would support operations into early 2024. This is a forward-looking estimate, excludes Calyxt, and depends on assumptions that may change.
- Calyxt management concluded there was substantial doubt about Calyxt’s ability to continue as a going concern. Including the February 2022 offering proceeds, Calyxt expected funding into late 2022 and anticipated needing additional capital. Failure to obtain financing could lead to delayed, reduced, or discontinued operations.
- Clinical-stage risks include unpredictable trial outcomes, severe adverse events and patient deaths in prior UCART studies, trial enrollment delays, regulatory holds, and uncertainty over whether preliminary results will persist. In the BALLI-01 study, two of six patients in the reported alemtuzumab-containing cohorts had blast reductions below 5% by day 28; these preliminary results are not evidence of established efficacy.
- Other key risks include complex, costly cell-therapy manufacturing; dependence on collaborators, suppliers, and licensees; competition; uncertain regulatory and reimbursement pathways; intellectual-property challenges; foreign-exchange exposure; and COVID-19-related disruption. Management reported no material legal proceeding likely to adversely affect the business.
- The company reported effective disclosure controls and internal control over financial reporting at December 31, 2021; the auditor issued unqualified opinions on the financial statements and internal controls. Cellectis does not intend to pay dividends in the foreseeable future.
Most important facts for investors to verify
- Whether the $20.0 million Cytovia consideration recorded as a receivable was collected, and the conditions attached to any cash or equity settlement.
- Current cash, financing needs, and progress against Cellectis’s early-2024 Therapeutics runway estimate, including actual collaboration and government-funding receipts.
- Calyxt’s post-offering cash runway, additional financing plans, going-concern status, and the effect of warrant exercise or further equity issuance on Cellectis’s ownership and governance rights.
- Updated clinical data, enrollment, safety events, and regulatory status for AMELI-01, BALLI-01, MELANI-01, and Allogene’s licensed programs.
- Manufacturing-facility utilization, regulatory readiness, production reliability, and spending relative to the company’s development plans.
- The full audited statements and notes for debt maturities, lease commitments, research-tax-credit recoverability, and the assumptions underlying management’s runway estimates.