Voyager Therapeutics, Inc. — Q2 2021 Form 10-Q
Reporting period: Three and six months ended June 30, 2021. The filing was signed August 9, 2021. Voyager is a clinical-stage gene therapy company with no approved products and no product-sale revenue; collaboration funding is its only reported revenue.
Financial performance and liquidity
| Metric | Q2 2021 | Q2 2020 | Six months 2021 | Six months 2020 |
|---|---|---|---|---|
| Collaboration revenue | $1.4 million | $28.7 million | $7.9 million | $46.7 million |
| Research and development expense | $19.5 million | $29.4 million | $41.9 million | $61.7 million |
| General and administrative expense | $10.4 million | $8.2 million | $20.2 million | $18.4 million |
| Operating loss | $28.6 million | $9.0 million | $54.2 million | $33.4 million |
| Net loss | $30.1 million | $8.7 million | $51.8 million | $32.9 million |
| Basic and diluted loss per share | $0.80 | $0.23 | $1.38 | $0.89 |
- At June 30, cash and cash equivalents were $117.8 million and marketable securities were $25.1 million, totaling $143.0 million. Including restricted cash, cash and equivalents were $119.6 million.
- Management expected existing cash, cash equivalents and marketable debt securities to fund planned operating expenses and capital expenditures into early 2023. The company said additional financing may be needed and is not assured.
- Six-month operating cash use was $44.0 million, compared with $50.0 million in 2020. Investing activities provided $57.0 million, primarily from securities maturities and sales; financing activities provided $0.4 million.
- Total liabilities were $98.2 million, including $45.7 million of operating lease liabilities. The filing reports no conventional borrowings. Operating leases carry future minimum payments of $59.8 million before $14.1 million of imputed interest.
- Accumulated deficit was $327.7 million. Profit margins are not meaningful given the absence of product sales and continuing operating losses.
Material changes and business developments
- Revenue fell sharply year over year, reflecting lower Neurocrine research activity, including reduced VY-AADC work, and the absence of revenue from AbbVie collaborations terminated in August 2020.
- R&D expense declined, largely from lower external clinical and manufacturing activity for VY-AADC and reduced R&D headcount. G&A rose, including compensation and stock-based compensation associated with the CEO’s departure and higher facility costs.
- Neurocrine’s termination of its VY-AADC collaboration became effective August 2, 2021, after quarter-end. Voyager regained worldwide program rights but will no longer receive VY-AADC cost reimbursements, milestones or royalties. It is exploring a partner and does not plan to advance the program alone.
- The RESTORE-1 Phase 2 Parkinson’s trial remained on FDA clinical hold following MRI abnormalities of uncertain clinical significance. Neurocrine remained the trial sponsor and IND holder; requested assessments and FDA information were still being addressed.
- Voyager discontinued its first-generation VY-HTT01 Huntington’s program and planned to withdraw its IND, despite the FDA having lifted the earlier clinical hold. It began developing a second-generation program using a novel capsid intended to support intravenous delivery.
- In August 2021, the board approved a workforce restructuring tied to a strategic shift toward novel capsid development. The company expected about $2.0 million in primarily severance-related costs, substantially in Q3 2021; additional costs were not yet estimable.
Outlook, commentary and risks
- Management expected near-term expenses to decrease after restructuring and pipeline reprioritization, while anticipating expenses could rise as platform work and development programs advance. No specific revenue or earnings guidance was provided.
- Strategic priorities include TRACER capsid discovery, programs for Huntington’s disease, ALS, SMA and GBA1-related diseases, continued Neurocrine programs including Friedreich’s ataxia, and vectorized antibody research. The company reported preclinical capsid data showing substantially higher expression in non-human-primate brain and spinal cord than AAV9; these are early research findings, not clinical results.
- The company cited substantial development, regulatory, manufacturing, funding, collaboration, intellectual-property and competition risks. COVID-19 restrictions and supply delays had affected laboratory activity and could disrupt research or trials further.
- A putative securities class action concerning the Huntington’s program and VY-HTT01 was voluntarily dismissed without prejudice on July 2, 2021; it was no longer pending as of the filing.
- Management concluded disclosure controls were effective at the reasonable-assurance level as of June 30, 2021. No material change in internal control over financial reporting was reported for the quarter.
Investor facts to verify
- Progress in resolving the RESTORE-1 clinical hold, the status and significance of the MRI findings, and whether a partner will pursue VY-AADC.
- Actual restructuring costs, headcount effects and realized savings compared with the expected $2.0 million charge.
- Cash burn, collaboration receipts and runway against management’s estimate of funding into early 2023, particularly following the loss of VY-AADC reimbursements.
- Milestones and funding arrangements for continuing Neurocrine programs, as well as the status of potential replacement partners for other programs.
- Whether preclinical novel-capsid findings translate into reproducible safety and efficacy, and the timeline and cost of advancing the revised Huntington’s program.