Voyager Therapeutics, Inc. — Q2 2022 Form 10-Q
Reporting period: Three and six months ended June 30, 2022. Voyager is a pre-commercial gene therapy and neuroscience company; it reported no product sales. Financial amounts below are in U.S. dollars unless noted.
Financial results and liquidity
| Metric | Q2 2022 | Q2 2021 | Six months 2022 | Six months 2021 |
|---|---|---|---|---|
| Collaboration revenue | $0.7 million | $1.4 million | $1.4 million | $7.9 million |
| Research and development expense | $12.5 million | $19.5 million | $26.9 million | $41.9 million |
| General and administrative expense | $7.6 million | $10.4 million | $15.2 million | $20.2 million |
| Net loss | $19.1 million | $30.1 million | $40.4 million | $51.8 million |
| Basic and diluted loss per share | $0.50 | $0.80 | $1.06 | $1.38 |
- At June 30, cash and cash equivalents were $78.3 million and marketable securities were $69.7 million, totaling $148.1 million. This compared with $132.5 million at December 31, 2021. Current assets were $151.6 million and current liabilities $97.9 million.
- Six-month operating cash flow was positive $15.9 million, versus $44.0 million used in the prior-year period. The 2022 inflow primarily reflected the $54.0 million Novartis upfront payment, which was recorded as deferred revenue rather than recognized as current-period revenue. Investing activities used $56.1 million, primarily for marketable securities purchases.
- Voyager reported no product revenue and no borrowings in the presented balance sheet. Total liabilities were $128.6 million, including $94.9 million of current and non-current deferred revenue; lease liabilities are also included in other liabilities.
- Management said existing cash, cash equivalents and marketable securities, together with expected Neurocrine cost reimbursements, should fund planned operations and capital expenditures into 2024. This estimate depends on its operating plan and anticipated reimbursements; additional funding may be needed.
Material changes and unusual items
- Revenue fell year over year, largely because Neurocrine’s termination of the VY-AADC collaboration reduced reimbursable research activity. The VY-AADC termination also returned worldwide program rights to Voyager, but ended its eligibility for related future milestones and royalties.
- Operating expenses declined following the 2021 restructuring, lower headcount and reduced program activity. The company also recorded a $2.5 million gain in Q2 after terminating its 75 Sidney Street lease without a penalty; it derecognized approximately $14.5 million of right-of-use assets and $17.0 million of lease liabilities.
- The Pfizer agreement’s $30.0 million upfront payment and Novartis agreement’s $54.0 million upfront payment remained deferred at June 30; neither agreement generated recognized revenue during the first half of 2022. Novartis’s payment materially supported operating cash flow.
- Accumulated deficit was $387.5 million at June 30. Marketable U.S. Treasury notes had $236,000 of unrealized losses, attributed to interest-rate changes rather than credit losses.
Outlook, business developments and risks
- Voyager’s strategy centers on its TRACER AAV capsid discovery platform and gene therapy and antibody programs. Its pipeline was predominantly in discovery or preclinical development; VY-AADC was the notable clinical-stage program, with the RESTORE-1 Phase 2 trial on FDA clinical hold and Neurocrine remaining sponsor and IND holder.
- In August 2022, after the quarter end, Voyager announced a portfolio prioritization focused on Alzheimer’s disease, Parkinson’s disease with GBA1 mutations and ALS with SOD1 mutations. It planned to continue selected other early-stage work while seeking partners for certain programs. Management described prospective timelines, including potential IND filings for prioritized programs, conditional on supportive preclinical results.
- Preclinical TRACER data included improved transduction in animal models; these findings do not establish clinical efficacy or safety in humans. The company cited further development, manufacturing, regulatory and translation risks, including sourcing non-human primates for studies.
- Key risks include continuing losses, reliance on collaborators and licensees, uncertain availability of future financing, early-stage pipeline execution, gene therapy safety and regulatory requirements, manufacturing complexity, competition, and potential disruption from COVID-19. The filing reported no material legal proceedings and no off-balance-sheet arrangements.
- No formal financial guidance was provided. Management expects near-term expenses to remain lower than prior levels but anticipates increases as programs advance and preclinical, clinical and manufacturing work expands.
Important facts for investors to verify
- Whether the stated runway into 2024 remains supportable as cash use, program priorities and Neurocrine reimbursements evolve.
- Option exercises, termination rights and resulting payments under the Pfizer and Novartis agreements; upfront fees are deferred revenue, not recurring recognized revenue.
- Updates on the RESTORE-1 clinical hold, requested safety assessments and any future partner or development plan for VY-AADC.
- Progress, reproducibility and human relevance of TRACER preclinical findings, and execution of the prioritized programs’ development timelines.
- Whether expense reductions can be sustained without impairing research progress, and whether additional financing or partnering will be required.