Viking Therapeutics, Inc. — Q1 2022 Form 10-Q
Reporting period: Three months ended March 31, 2022. Viking is a clinical-stage biopharmaceutical company developing therapies for metabolic and endocrine disorders. It reported no revenue.
Financial performance and position
| Metric | Q1 2022 | Q1 2021 / comparison |
|---|---|---|
| Revenue | $0 | $0 |
| Research and development expense | $12.6 million | $11.5 million; up 8.8% |
| General and administrative expense | $3.7 million | $2.7 million; up 37.0% |
| Operating expenses | $16.2 million | $14.2 million |
| Net loss | $16.1 million | $14.0 million |
| Net loss per share | $0.21 | $0.19 |
| Cash used in operating activities | $10.5 million | $10.9 million |
| Cash, cash equivalents and short-term investments | $184.9 million at March 31, 2022 | $202.1 million at December 31, 2021 |
Margins are not meaningful because the company had no revenue. Cash and cash equivalents were $12.5 million; short-term investments were $172.4 million. Total liabilities were $12.8 million, including $1.6 million of lease liabilities; the filing does not report conventional borrowings. Accumulated deficit was $239.3 million. Unrealized investment losses reduced other comprehensive income by $0.9 million.
Material changes and notable items
- R&D expense increased mainly from preclinical work, drug-candidate manufacturing and stock-based compensation; lower clinical-study costs partly offset these increases.
- G&A expense rose mainly due to higher stock-based compensation and legal services.
- Financing cash flow included $5.1 million of share repurchases under the prior program. The company repurchased 1,464,217 shares under that program, which ended March 17, 2022; it authorized a new program of up to $50 million, with no purchases under the new program through March 31.
- The company began occupying a new headquarters lease in March 2022, running through July 2027. The reported lease liability was $1.6 million.
Programs, outlook and risks
- VK2809: Phase 2b VOYAGE trial in biopsy-confirmed NASH was ongoing, targeting approximately 340 patients. The filing provides no new efficacy results or completion guidance.
- VK0214: FDA placed the Phase 1b X-ALD trial on clinical hold in January 2022 and requested an additional preclinical study. Viking expected to submit the requested information in Q2 2022; the hold was not attributed to findings from ongoing or completed studies.
- VK2735: Phase 1 single- and multiple-ascending-dose trial began in January 2022.
- VK5211: Viking said it intended to pursue partnering or licensing before further clinical studies.
- Management expected cash, cash equivalents and investments to fund operations through at least June 30, 2023. It anticipated continuing losses and increasing R&D spending, and stated that additional capital would be needed to fund operations and complete ongoing and planned trials. No specific earnings or revenue guidance was provided.
- Key risks include clinical and regulatory uncertainty, the VK0214 hold, possible trial delays or enrollment challenges, COVID-19-related disruption, dependence on third-party manufacturers and CROs, reliance on Ligand-licensed technologies, and the possibility that additional financing may be unavailable or dilutive.
Important facts for investors to verify
- Whether Viking submitted the requested VK0214 preclinical information and whether the FDA lifted the clinical hold.
- Current enrollment, timing and emerging results for the VK2809 VOYAGE study and VK2735 Phase 1 trial.
- Actual cash burn and remaining runway relative to management’s stated funding horizon, including the impact of trial spending and share repurchases.
- Any subsequent use of the new $50 million repurchase authorization or the $125 million ATM facility; no ATM shares had been sold through March 31, 2022.
- Changes in collaboration or licensing plans, and the latest status of key assets licensed from Ligand.