Autolus Therapeutics plc — 2021 Form 20-F
Reporting period: Fiscal year ended December 31, 2021. This is an annual report, not a quarterly filing. Financial statements are prepared under U.S. GAAP and reported in U.S. dollars. Autolus is a clinical-stage cell-therapy company with no products approved for sale.
Financial performance and position
| Metric | 2021 | 2020 |
|---|---|---|
| Grant income | $0.8 million | $1.5 million |
| License revenue | $1.5 million | $0.2 million |
| Research and development expense | $134.8 million | $134.9 million |
| General and administrative expense | $31.9 million | $35.0 million |
| Net loss | $142.1 million | $142.1 million |
| Cash used in operating activities | $117.9 million | $117.8 million |
| Cash used in investing activities | $8.9 million | $14.7 million |
| Cash provided by financing activities | $284.1 million | $74.4 million |
| Cash and cash equivalents at year-end | $310.3 million | $153.3 million |
Total assets were $405.6 million and shareholders’ equity was $313.3 million at year-end. Current liabilities were $28.6 million. The company reported a $47.0 million liability related to the sale of future royalties and sales milestones under its Blackstone agreement; this is not presented as conventional borrowings. Operating lease liabilities totaled $21.0 million. The filing does not provide a meaningful operating margin or product gross margin, given the absence of product sales.
Revenue remains immaterial and is from grants and licensing, not commercial products. The company reported an accumulated deficit of $521.3 million and expects continued operating losses. Its $23.9 million income tax benefit primarily reflects U.K. research and development tax credits.
Changes from the prior year
- Net loss was essentially unchanged year over year. R&D expense was also nearly flat; lower clinical-trial costs were offset by higher compensation, facility, manufacturing-consumable and IT costs.
- License revenue rose to $1.5 million, mainly from a non-refundable upfront payment under a research and license agreement with Moderna. No development milestone or royalty revenue was recognized.
- Cash increased by $157.0 million, principally due to equity financing and Blackstone proceeds. Financing included a February public offering that generated $106.9 million net, $29.6 million net from the at-the-market program, and Blackstone-related proceeds.
- Ordinary shares outstanding rose from 52.3 million to 90.9 million during 2021, reflecting substantial equity issuance and dilution.
- The company reduced its workforce by approximately 20% as part of a January 2021 restructuring and reprioritized R&D around obe-cel. It also incurred a $0.7 million loss on disposal of leasehold improvements.
Outlook, management commentary and principal risks
- Management said year-end cash of $310.3 million was expected to fund current and planned operating expenses and capital expenditures for at least 12 months from the March 10, 2022 filing date. This is a forecast based on assumptions, not a guarantee; management expects to need additional funding before anticipated commercialization.
- Key stated development expectations included initial Phase 2 FELIX data for obe-cel in the second half of 2022 and fuller data in the first half of 2023; AUTO4 interim Phase 1 data and further AUTO1/22 data in the first half of 2022; and planned AUTO6NG and AUTO8 trial starts in 2022. These are forward-looking expectations and may change.
- Obe-cel’s adult ALLCAR19 results included 17 of 20 patients achieving MRD-negative complete remission at one month; reported 24-month morphological event-free survival was 46%, based on a small trial. In the FELIX Phase 1b portion, 12 of 16 patients achieved CR/CRi at one month. These early clinical results are not proof of approval or commercial success.
- COVID-19 had disrupted some clinical-site screening and enrollment and could affect trials, manufacturing, supply chains and timelines. Management said it had not experienced significant financial impact to date.
- Major risks include continued losses and need for capital; uncertain clinical efficacy, safety and regulatory approval; cell-therapy manufacturing, logistics and scale-up challenges; competition; patient enrollment; and intellectual-property risks. The filing notes third-party U.S. patents relevant to obe-cel that expire between 2023 and 2025, which could affect U.S. launch timing if not licensed, invalidated or found not to apply.
- The Blackstone agreement provides up to $150 million for obe-cel and related programs, including $50 million received upfront and up to $100 million subject to milestones. In exchange, Autolus owes a capped mid-single-digit sales royalty and sales milestones, and granted security over specified assets and intellectual property. The agreement includes operating restrictions and potential liquidated damages for certain defaults.
- Other unusual items include a $1.1 million non-cash interest expense on the Blackstone liability, lease restructuring and subleasing activity, and foreign-exchange losses. The company does not hedge currency exposure.
Important facts for investors to verify
- Check subsequent clinical disclosures against the filing’s obe-cel and other program timelines, trial enrollment, efficacy, durability and safety data.
- Confirm actual cash burn and financing after year-end, and whether the stated 12-month runway remains valid; assess dilution and remaining ATM capacity.
- Review Blackstone’s remaining milestone funding conditions, royalty cap, security interests, covenants and default consequences.
- Track progress, licensing and regulatory implications of the potential obe-cel patent constraints in the United States.
- Verify manufacturing-facility completion, regulatory readiness, capacity and cost, as well as the company’s ability to maintain clinical supply.
- Assess the sustainability and eligibility of U.K. R&D tax credits, which contribute materially to reported tax benefits and liquidity.