Viking Therapeutics, Inc. — Q3 2022 Form 10-Q
Reporting period: Three and nine months ended September 30, 2022. Viking is a clinical-stage biopharmaceutical company developing therapies for metabolic and endocrine disorders; it has no approved products and has generated no revenue. Financial amounts below are in U.S. dollars.
Key financial results
| Metric | Q3 2022 | Q3 2021 | Nine months 2022 | Nine months 2021 |
|---|---|---|---|---|
| Revenue | $0 | $0 | $0 | $0 |
| Research and development expense | $12.0M | $10.8M | $38.1M | $35.1M |
| General and administrative expense | $4.2M | $2.6M | $12.0M | $8.0M |
| Total operating expenses | $16.2M | $13.4M | $50.1M | $43.2M |
| Net loss | $15.8M | $13.2M | $49.3M | $42.6M |
| Basic and diluted loss per share | $0.21 | $0.17 | $0.64 | $0.55 |
| Cash used in operating activities | — | $37.5M | $35.2M |
At September 30, 2022, cash and cash equivalents were $29.4M and short-term investments were $125.6M, totaling approximately $155.0M. Total assets were $166.7M, stockholders’ equity was $151.3M, and total liabilities were $15.4M, including $1.6M of operating lease liabilities. The filing reports no borrowings. Management said available cash and investments were expected to fund operations through at least December 31, 2023.
For the first nine months, investing activities provided $47.5M net, primarily as investment maturities exceeded purchases; financing activities used $6.6M, including $6.8M of share repurchases. The company held 76.7M common shares outstanding at quarter-end. Available-for-sale investments had $1.36M of aggregate unrealized losses, recorded in other comprehensive loss; management said it did not intend, and was not likely required, to sell them before recovery or maturity.
Changes versus prior comparable periods
- Q3 R&D expense increased 10.8% year over year; nine-month R&D expense increased 8.3%. Management attributed the increases mainly to manufacturing, clinical studies, and personnel costs, partly offset by Australian R&D tax incentive proceeds and certain lower costs.
- Q3 G&A expense increased 62.5%; nine-month G&A expense increased 49.5%, primarily reflecting higher legal, stock-based compensation, salary, and benefit costs.
- Net loss increased from $13.2M to $15.8M for Q3 and from $42.6M to $49.3M for the nine-month period. Higher interest income partly offset operating expenses.
- Operating cash use rose from $35.2M to $37.5M for the nine months. Cash and cash equivalents increased to $29.4M from $26.4M at year-end 2021, while short-term investments declined to $125.6M from $175.7M.
Programs, outlook, and risks
- VK2809: Phase 2b VOYAGE trial in biopsy-confirmed NASH, assessing liver-fat change at week 12 and histologic outcomes after 52 weeks of dosing.
- VK0214: Phase 1b trial in adults with the AMN form of X-linked adrenoleukodystrophy, evaluating safety and tolerability over 28 days.
- VK2735: Phase 1 single- and multiple-ascending-dose trial in healthy adults; the company announced its initiation in January 2022.
- VK5211: Prior Phase 2 results were described as positive; Viking planned to pursue partnering or licensing before further clinical studies.
- Management expects research and development expense and losses to increase as programs advance. It said additional capital will be needed to fund operations and ongoing and planned trials; financing may not be available on acceptable terms, potentially requiring development delays, reductions, or licensing of program rights.
- Key disclosed risks include clinical, regulatory, enrollment, manufacturing and supply-chain uncertainty; reliance on third parties and technology licensed from Ligand; competition; and possible COVID-19-related trial or operational disruption. The filing gives no specific revenue or earnings guidance.
- The company reported no material legal proceedings and no subsequent events requiring financial-statement recognition, adjustment, or disclosure. Disclosure controls were concluded effective as of period-end.
Important facts for investors to verify
- Current trial progress, enrollment, timing, and forthcoming results for VOYAGE, VK0214, and VK2735; the filing provides no new efficacy readout.
- Cash burn and investment maturities against management’s stated runway, particularly as development spending is expected to rise.
- Remaining authorization and pace of repurchases under the new $50M program, and the resulting effects on liquidity and share count.
- Terms and obligations under the Ligand license, including potential aggregate development, regulatory, and sales milestones of approximately $1.54B and single-digit royalties on future worldwide net sales.
- Whether COVID-19, clinical-site capacity, or manufacturing and supplier constraints cause trial delays or added costs.