Voyager Therapeutics, Inc. — Q1 2022 Form 10-Q
Reporting period: Three months ended March 31, 2022. Voyager is an early-stage gene therapy company developing AAV-based treatments and platform technologies, including its TRACER capsid discovery platform. It has no approved products and has not generated product sales.
Financial results and position
| Metric | Q1 2022 | Q1 2021 |
|---|---|---|
| Collaboration revenue | $0.7 million | $6.5 million |
| Research and development expense | $14.3 million | $22.3 million |
| General and administrative expense | $7.7 million | $9.7 million |
| Operating loss | $21.4 million | $25.6 million |
| Net loss | $21.3 million | $21.6 million |
| Net loss per share, basic and diluted | $0.56 | $0.58 |
| Net cash from (used in) operating activities | $34.4 million | $(21.3) million |
- At March 31, cash and cash equivalents were $131.9 million and marketable securities were $35.0 million, totaling $166.8 million. Cash, cash equivalents and restricted cash totaled $133.7 million.
- Total assets were $224.2 million; total liabilities were $148.3 million and stockholders’ equity was $75.9 million. The filing does not report financial borrowings; liabilities include lease obligations and deferred revenue.
- Gross margin is not meaningful because the company had no product sales. Operating cash inflow chiefly reflected the $54.0 million Novartis upfront payment; the payment was recorded as deferred revenue, not Q1 collaboration revenue.
Changes versus the prior period
- Revenue fell $5.8 million year over year, primarily because Neurocrine reduced research and development services following its termination of the VY-AADC collaboration program.
- R&D expense decreased $8.0 million, mainly from lower personnel and contractor costs and reduced external clinical and manufacturing activity. G&A expense declined $2.1 million, including lower compensation and legal costs.
- Net loss improved by $0.3 million, despite $3.9 million less other income than in Q1 2021; the prior-year amount primarily reflected a gain on ClearPoint Neuro equity securities.
- Deferred revenue rose to $95.4 million from $42.1 million at year-end, largely reflecting the Novartis upfront payment and the remaining deferred amounts under licensing agreements.
Outlook, developments and risks
- Management said existing cash, cash equivalents and marketable securities, together with expected Neurocrine cost reimbursements, should fund planned operating expenses and capital needs into 2024. This is based on the current operating plan and is not a guarantee; the company expects to need substantial additional funding over time.
- In March 2022, Voyager signed a TRACER capsid option and license agreement with Novartis and received $54.0 million upfront. In addition, its October 2021 Pfizer agreement included a $30.0 million upfront payment. Both upfront payments remain deferred and are recognized as options are exercised or expire. Further option fees, milestones and royalties are contingent on future events.
- Voyager’s strategy is to increase investment in TRACER capsids and advance preclinical programs, including programs for Huntington’s disease, monogenic ALS, SMA and GBA1-related diseases. Management anticipated near-term expense reductions from restructuring and pipeline reprioritization, with expenses potentially rising as development advances.
- The RESTORE-1 Phase 2 trial of VY-AADC for Parkinson’s disease remained on FDA clinical hold; Neurocrine remained sponsor and IND holder after ending its participation in that program in 2021. Voyager said it would not advance the program without a partner if sponsorship returned to it. Most other programs were in discovery or preclinical development.
- Key risks include continued losses and potential need for capital; uncertain preclinical, clinical and regulatory outcomes; gene therapy safety and manufacturing challenges; dependence on collaborators and licensors; intellectual-property risks; and possible COVID-19-related disruption. The filing also cites difficulty sourcing non-human primates for some studies. No material legal proceedings or litigation reserves were reported at March 31, 2022.
- Management reported effective disclosure controls as of quarter-end and no material change in internal control over financial reporting during the quarter.
Important facts for investors to verify
- Whether the stated cash runway into 2024 remains supported by spending, collaboration reimbursements and updated development plans.
- How and when Pfizer and Novartis options are exercised, and the timing of recognition of their deferred upfront payments.
- Any FDA, DSMB or sponsor updates concerning the RESTORE-1 clinical hold and any decision on the program’s future or partnering.
- Progress, timelines and funding needs for TRACER and the preclinical pipeline, including whether material study, manufacturing or animal-supply delays arise.
- Future changes in revenue, operating cash burn, deferred revenue and the company’s need for additional financing or new licensing transactions.