Voyager Therapeutics(VYGR) - 2024 Q3 - Quarterly Results

Third Quarter 2024 Financial and Operating Results Overview Summary of Key Achievements and Outlook Voyager advanced its anti-tau antibody for Alzheimer's, strengthened Novartis and Neurocrine partnerships, and affirmed a strong cash position into 2027 Summary of Q3 2024 Highlights Voyager completed VY7523 trial enrollment, secured a Novartis capsid license, and achieved a Neurocrine development candidate - Enrollment and dosing completed for anti-tau antibody VY7523 SAD clinical trial, with top-line data expected in H1 2025[1][4] - Licensed TRACER™ capsid to Novartis for a fifth program, receiving a $15 million upfront payment and eligibility for up to $305 million in milestone payments[1][3] - Achieved a third development candidate with Neurocrine Biosciences, triggering a $3 million milestone payment[1][3][4] CEO's Strategic Commentary CEO emphasized growing clinical evidence for tau as an Alzheimer's target, confident in Voyager's programs and robust cash position - Increasing confidence that a tau-targeting antibody can slow accumulation in Alzheimer's patients, offering significant clinical benefit[2] - Clinical-stage anti-tau antibody VY7523 expects initial tau PET imaging data in H2 2026, with tau silencing gene therapy advancing to IND in 2026[2] - Strong cash position of $345 million is expected to provide runway into 2027, enabling multiple data readouts[2] Operational and Clinical Development Updates Recent Clinical and Partnership Achievements Voyager advanced its anti-tau antibody program and expanded strategic collaborations with Novartis and Neurocrine, securing licenses and milestones Partnership Progress Voyager expanded Novartis collaboration with a TRACER™ capsid license and achieved a Neurocrine development candidate, triggering milestones - Licensed a novel TRACER™ capsid to Novartis for a fifth gene therapy program, receiving a $15 million upfront payment and eligibility for up to $305 million in milestone payments and royalties[3] - Selected a development candidate in a gene therapy program with Neurocrine Biosciences, resulting in a $3 million milestone payment[3][4] Clinical Program Updates Enrollment and dosing completed for VY7523 SAD clinical trial for Alzheimer's, with initial safety and PK data expected in H1 2025 - Enrollment and dosing completed in the VY7523 SAD clinical trial for anti-tau antibody in Alzheimer's disease[4] - Top-line safety and pharmacokinetic data from the VY7523 SAD clinical trial are expected in H1 2025[4] Preclinical Data Presentation Preclinical data for VY7523 murine surrogate showed significant reduction in pathological tau spread, supporting its C-terminal mechanism - Murine surrogate of VY7523 (C-terminal directed) significantly reduced human pathological tau spread in a p301S mouse seeding model[4] - Murine surrogates of two N-terminal directed antibodies that failed clinical trials showed no significant reduction in tau spread[4] Anticipated Upcoming Milestones Voyager outlined key clinical and regulatory milestones through H2 2026, including data readouts, IND/CTA filings, and new clinical trials Anticipated Upcoming Milestones | Timeline | Milestone | | :--------- | :---------- | | H1 2025 | Initial safety and pharmacokinetic data from VY7523 SAD clinical trial | | Mid-2025 | U.S. IND and Canadian CTA filings for SOD1 silencing gene therapy VY9323 in ALS patients | | 2025 | Initiation of Multiple Ascending Dose (MAD) clinical trial for VY7523 in AD patients | | 2025 | IND filings for NBIX-partnered GBA-1 and Friedreich's ataxia gene therapies | | 2026 | U.S. IND and Canadian CTA filings for tau-silencing gene therapy for Alzheimer's disease | | H2 2026 | Initial tau PET imaging data from MAD clinical trial of VY7523 in Alzheimer's disease | Financial Performance Third Quarter 2024 Financial Results Voyager reported increased collaboration revenue and reduced net loss in Q3 2024, driven by partnerships, with R&D expenses up and G&A stable Collaboration Revenues Collaboration revenue for Q3 2024 substantially increased due to enhanced revenue recognition from Novartis and Neurocrine agreements Collaboration Revenue (Q3 2024 vs Q3 2023) | Period | Collaboration Revenue (in millions) | | :---------- | :-------------------------------- | | Q3 2024 | $24.6 | | Q3 2023 | $4.6 | | Change | +434.8% | - The increase in collaboration revenue was primarily due to increased revenue recognized under the Novartis and Neurocrine agreements[6] Net Loss Voyager's net loss significantly decreased in Q3 2024, primarily due to the substantial increase in collaboration revenue Net Loss (Q3 2024 vs Q3 2023) | Period | Net Loss (in millions) | | :---------- | :------------------- | | Q3 2024 | $9.0 | | Q3 2023 | $25.9 | | Change | -65.2% | - The decrease in net loss is primarily due to increased collaboration revenue recognized during Q3 2024[6] Operating Expenses R&D expenses increased in Q3 2024 due to pipeline advancement and facilities, while G&A remained stable, reflecting disciplined management Operating Expenses (Q3 2024 vs Q3 2023) | Expense Category | Q3 2024 (Millions) | Q3 2023 (Millions) | YoY Change | | :---------------------- | :----------------- | :----------------- | :--------- | | Research and development | $30.2 | $25.9 | +16.6% | | General and administrative | $8.2 | $8.3 | -1.2% | - Increase in R&D expenses primarily resulted from increased development team hires and facilities costs supporting the advancing pipeline[7] - Consistent G&A spend reflects continued disciplined expense management[8] Cash Position Voyager maintained a strong cash position as of September 30, 2024, excluding significant upfront and milestone payments received in October Cash, Cash Equivalents and Marketable Securities | As of | Amount (in millions) | | :---------------- | :------------------- | | September 30, 2024 | $345.4 | - The reported cash position does not include the $15.0 million upfront payment from Novartis or the $3.0 million milestone from Neurocrine, both received in October 2024[8] Financial Guidance Voyager expects current cash, equivalents, marketable securities, and collaboration income to fund operations and capital expenditures into 2027 - Cash, cash equivalents, marketable securities, and expected reimbursements from Neurocrine and Novartis collaborations, plus interest income, are projected to fund operations and capital expenditures into 2027[9] Company Information and Disclosures About Voyager Therapeutics Voyager Therapeutics is a biotech company developing neurogenetic medicines for neurological diseases, leveraging its TRACER™ AAV capsid platform - Voyager Therapeutics is a biotechnology company dedicated to advancing neurogenetic medicines to modify and cure neurological diseases[11] - The company's pipeline includes programs for Alzheimer's, ALS, Parkinson's, and other central nervous system diseases[11] - Many programs are derived from the TRACER™ AAV capsid discovery platform, designed for high brain penetration with genetic medicines[11] Forward-Looking Statements This section provides a standard disclaimer for forward-looking statements, subject to inherent uncertainties and risks that could cause actual results to differ - Forward-looking statements are based on management estimates and assumptions, inherently uncertain and subject to risks that may cause actual results to differ materially[15] - Risks include regulatory decisions, timing and outcomes of studies, data availability, product candidate success, and collaboration partner obligations[15] - Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, except as required by law[17] Conference Call and Contacts Voyager hosted a conference call and webcast to discuss Q3 2024 results, with contact information provided for investors and media - Voyager hosted a conference call and webcast on November 12, 2024, at 4:30 p.m. ET to discuss Q3 2024 financial and operating results[10] - A live webcast and replay of the call are available on the Investors section of the Voyager website[10] - Contact information for investors (Michael Hencke) and media (Brooke Shenkin) is provided[18] Selected Financial Information Statement of Operations The Statement of Operations details Voyager's financial performance for the three and nine months ended September 30, 2024, highlighting changes in revenue and net loss Statement of Operations (Unaudited) | Statement of Operations Items: | Three Months Ended September 30, 2024 (in thousands) | Three Months Ended September 30, 2023 (in thousands) | Nine Months Ended September 30, 2024 (in thousands) | Nine Months Ended September 30, 2023 (in thousands) | | :----------------------------- | :--------------------------------------------------- | :--------------------------------------------------- | :-------------------------------------------------- | :-------------------------------------------------- | | Collaboration revenue | $24,629 | $4,614 | $73,723 | $159,947 | | Operating expenses: | | | | | | Research and development | 30,241 | 25,863 | 91,785 | 66,416 | | General and administrative | 8,168 | 8,258 | 26,926 | 25,580 | | Total operating expenses | 38,409 | 34,121 | 118,711 | 91,996 | | Operating (loss) income | (13,780) | (29,507) | (44,988) | 67,951 | | Total other income | 4,779 | 3,429 | 14,554 | 8,570 | | (Loss) income before income taxes | (9,001) | (26,078) | (30,434) | 76,521 | | Income tax provision (benefit) | 43 | (177) | 81 | 586 | | Net (loss) income | $(9,044) | $(25,901) | $(30,515) | $75,935 | | Net (loss) income per share, basic | $(0.16) | $(0.59) | $(0.53) | $1.85 | | Net (loss) income per share, diluted | $(0.16) | $(0.59) | $(0.53) | $1.78 | | Weighted-average common shares outstanding, basic | 57,851,110 | 43,864,838 | 57,564,413 | 40,962,116 | | Weighted-average common shares outstanding, diluted | 57,851,110 | 43,864,838 | 57,564,413 | 42,610,724 | Selected Balance Sheet Items The Selected Balance Sheet Items provide Voyager's financial position as of September 30, 2024, showing increased cash, equivalents, and marketable securities Selected Balance Sheet Items (Unaudited) | Selected Balance Sheet Items | September 30, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--------------------------------------- | :-------------------------------- | :------------------------------- | | Cash, cash equivalents, and marketable securities | $345,360 | $230,875 | | Total assets | $426,041 | $351,281 | | Accounts payable and accrued expenses | $14,602 | $18,427 | | Deferred revenue | $34,782 | $75,240 | | Total stockholders' equity | $330,310 | $236,320 |