Nautilus Biotechnology, Inc. — FY2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023; comparable period is FY2022. Nautilus is a development-stage life sciences company developing a proteomics platform. It has not launched products commercially or generated revenue.
Financial results and liquidity
| Metric | FY2023 / Dec. 31, 2023 | FY2022 / Dec. 31, 2022 | Change |
|---|---|---|---|
| Revenue | $0 | $0 | No revenue in either period |
| Research and development expense | $47.3 million | $37.7 million | Up 25% |
| General and administrative expense | $28.9 million | $25.9 million | Up 11% |
| Total operating expenses | $76.2 million | $63.6 million | Up 20% |
| Interest income | $12.6 million | $5.8 million | Up 116% |
| Net loss | $63.7 million | $57.9 million | Loss widened 10% |
| Net loss per share, basic and diluted | $0.51 | $0.46 | Loss per share widened |
| Net cash used in operating activities | $51.7 million | $45.8 million | Cash use increased |
| Net cash used in investing activities | $43.7 million | $25.7 million | Cash use increased |
| Cash, cash equivalents and short-term investments | $173.4 million | $184.5 million | Down $11.1 million |
Separately, total cash, cash equivalents and investments, including long-term investments, were $264.1 million at year-end 2023, versus $313.6 million in 2022. Current assets were $176.8 million and current liabilities $9.1 million. The balance sheet reports $34.6 million of operating lease liabilities, but no borrowings or other financial debt. Gross margins are not applicable because the company has no product revenue. Net loss reflects operating expenses partly offset by investment income.
Management said available cash, cash equivalents and short-term investments were expected to fund planned operating expenses and capital expenditures for at least 12 months from the filing/financial-statement issuance, subject to risks and assumptions. This is not a guarantee of future funding sufficiency.
Business progress, outlook and key risks
- The company is developing an instrument, consumables and cloud-based analytics intended to identify and quantify proteins and protein modifications. Its platform remains in development and requires further technical and scientific validation.
- Management expects early-access engagements and associated revenue in 2025, followed by broad commercialization targeted for 2025. These are forward-looking plans, not assured milestones; the filing says launch specifications are being refined based on customer feedback, including sample input and proteome coverage.
- Research collaborations include Genentech, Amgen, MD Anderson Cancer Center and the Translational Genomics Research Institute. The disclosed research collaborations are not expected to generate revenue.
- Operating expenses rose primarily with hiring, facilities and laboratory spending; lower external development-services costs partially offset R&D increases. Higher interest rates drove the increase in interest income.
- Major risks include technical or commercialization delays, uncertain market acceptance, competition, reliance on third-party and single-source suppliers, manufacturing scale-up, and the possibility of needing additional capital. The company expects losses and negative operating cash flow to continue.
- The planned initial market is research use only. Clinical or diagnostic applications could require regulatory clearance or approval; FDA scrutiny of research-use-only products and evolving laboratory-developed-test rules are relevant uncertainties.
- On December 14, 2023, Nautilus filed a declaratory-judgment suit against SomaLogic/Standard BioTools and Caltech after allegations of patent infringement. The company disputes infringement; outcome and costs are uncertain.
- Nautilus reported an unauthorized-access incident involving an employee account in January 2024. It said the incident did not materially disrupt operations or affect financial or operating results.
- The independent auditor issued an unqualified opinion on the financial statements. Management concluded internal control over financial reporting was effective; the auditor did not attest to internal controls because the company qualifies for the emerging-growth-company exemption.
Important facts for investors to verify
- Whether technical validation, refined launch specifications, and manufacturing readiness support the 2025 early-access and broad-launch targets.
- Cash burn, investment maturities, and runway assumptions; note the distinction between $173.4 million of cash and short-term investments and $264.1 million including long-term investments.
- Whether customer collaborations produce independent, peer-reviewed validation and meaningful adoption or revenue; current research collaborations are not revenue-generating.
- Developments in the patent litigation, supplier concentration, regulatory treatment of research-use-only products, and any additional financing needs or dilution.