Voyager Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Voyager Therapeutics, Inc. filed its 2023 10-K, highlighting gene therapy development and key partnerships.</b>

AI Summary

Voyager Therapeutics, Inc. (VYGR) filed a Annual Report (10-K) with the SEC on February 28, 2024. Voyager Therapeutics, Inc. filed its 10-K report for the fiscal year ending December 31, 2023. The company is involved in the development of gene therapies for serious neurological diseases. Key collaborations include agreements with Novartis Pharma AG and Neurocrine Biosciences, Inc. The report details various programs such as the VYAAADC program and Glucosylceramidase Beta One program. Voyager Therapeutics is incorporated in Delaware and headquartered in Lexington, MA.

Why It Matters

For investors and stakeholders tracking Voyager Therapeutics, Inc., this filing contains several important signals. The 10-K filing provides a comprehensive overview of Voyager's gene therapy pipeline and strategic collaborations, crucial for understanding its future development and commercialization potential. Details on agreements with major pharmaceutical companies like Novartis and Neurocrine are vital for assessing potential revenue streams from milestones and royalties.

Risk Assessment

Risk Level: medium — Voyager Therapeutics, Inc. shows moderate risk based on this filing. The company is in the biotechnology sector, which is characterized by high R&D costs, long development cycles, and significant regulatory hurdles, as evidenced by the nature of gene therapy development.

Analyst Insight

Investors should closely monitor the progress of Voyager's gene therapy programs and the outcomes of its collaborations with Novartis and Neurocrine for potential value inflection points.

Key Numbers

• 2023-12-31 — Fiscal Year End (Report period)
• 2024-02-28 — Filing Date (Date of submission)
• 2015-10-01 — Plan Start Date (Employee Stock Purchase Plan 2015)
• 2023-12-28 — Agreement Date (Novartis Collaboration Agreement 2023)

Key Players & Entities

• Voyager Therapeutics, Inc. (company) — Filer
• Novartis Pharma AG (company) — Collaboration partner
• Neurocrine Biosciences, Inc. (company) — Collaboration partner
• Lexington, MA (location) — Business address
• Delaware (location) — State of incorporation

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The development and commercialization of gene therapies are subject to extensive regulatory review and approval processes by agencies like the FDA, which can be lengthy and uncertain.
• Funding and Liquidity [high — financial]: The company's ability to continue as a going concern depends on its ability to secure additional funding, given its history of operating losses and substantial research and development expenses.
• Reliance on Third Parties [medium — operational]: Voyager relies on third-party manufacturers for the production of its gene therapy candidates, and any disruptions or quality issues with these manufacturers could impact development timelines.
• Competition [medium — market]: The gene therapy field is highly competitive, with numerous companies developing similar or alternative treatments, which could affect Voyager's market position and commercial success.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-02-28: 10-K Filing Date — Date Voyager Therapeutics filed its annual report.
• 2023-12-28: Novartis Collaboration Agreement — Key date related to a significant partnership.
• 2023-01-01: Neurocrine Collaborative Agreement Start — Start date for a key collaboration.

Glossary

Gene Therapy

A type of genetic treatment that uses genes to treat or prevent disease. (Voyager's core business and product focus.)

Key Financial Figures

• $0.001 — ange on which registered Common Stock, $0.001 par value VYGR Nasdaq Global Select
• $345 billion — as in the United States is estimated at $345 billion. Our Treatment Approach We have main

Filing Documents

• vygr-20231231x10k.htm (10-K) — 3330KB
• vygr-20231231xex10d43.htm (EX-10.43) — 656KB
• vygr-20231231xex10d44.htm (EX-10.44) — 333KB
• vygr-20231231xex10d45.htm (EX-10.45) — 143KB
• vygr-20231231xex10d46.htm (EX-10.46) — 23KB
• vygr-20231231xex10d47.htm (EX-10.47) — 40KB
• vygr-20231231xex21d1.htm (EX-21.1) — 5KB
• vygr-20231231xex23d1.htm (EX-23.1) — 7KB
• vygr-20231231xex31d1.htm (EX-31.1) — 10KB
• vygr-20231231xex31d2.htm (EX-31.2) — 10KB
• vygr-20231231xex32d1.htm (EX-32.1) — 13KB
• vygr-20231231xex97d1.htm (EX-97.1) — 21KB
• vygr-20231231x10k006.jpg (GRAPHIC) — 76KB
• 0001558370-24-001988.txt (&nbsp;) — 13544KB
• vygr-20231231.xsd (EX-101.SCH) — 68KB
• vygr-20231231_cal.xml (EX-101.CAL) — 67KB
• vygr-20231231_def.xml (EX-101.DEF) — 326KB
• vygr-20231231_lab.xml (EX-101.LAB) — 581KB
• vygr-20231231_pre.xml (EX-101.PRE) — 513KB
• vygr-20231231x10k_htm.xml (XML) — 2139KB

Business

Business 7 Item 1A.

Risk Factors

Risk Factors 49 Item 1B. Unresolved Staff Comments 111 Item 1C. Cybersecurity 111 Item 2.

Properties

Properties 112 Item 3.

Legal Proceedings

Legal Proceedings 112 Item 4. Mine Safety Disclosures 112 PART II. Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 112 Item 6. [ Reserved ] 113 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 113 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 123 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 124 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 124 Item 9A.

Controls and Procedures

Controls and Procedures 124 Item 9B. Other Information 125 PART III. Item 10. Directors, Executive Officers and Corporate Governance 126 Item 11.

Executive Compensation

Executive Compensation 126 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 126 Item 13. Certain Relationships and Related Transactions, and Director Independence 126 Item 14. Principal Accountant Fees and Services 126 PART IV. Item 15. Exhibits and Financial Statement Schedules 126 Item 16. Form 10-K Summary 127

Signatures

Signatures 2 Table of Contents

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "contemplate," "anticipate," "goals," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about: our plans to develop and commercialize our product candidates based on adeno-associated virus, or AAV, gene therapy and our proprietary antibodies; our ability to continue to develop our proprietary gene therapy platform technologies, including our TRACER TM (Tropism Redirection of AAV by Cell-type-specific Expression of RNA) discovery platform and our vectorized antibody platform, our proprietary antibody program, and our gene therapy and vectorized antibody programs; our ability to identify and optimize product candidates and proprietary AAV capsids; our strategic collaborations and licensing agreements with, and funding from, our collaboration partners Neurocrine Biosciences, Inc. and Novartis Pharma AG, or Novartis, and our licensee Alexion, AstraZeneca

BUSINESS

ITEM 1. BUSINESS We are a biotechnology company whose mission is to leverage the power of human genetics to modify the course of and ultimately cure neurological diseases. Our pipeline includes programs for Alzheimer's disease, or AD; amyotrophic lateral sclerosis, or ALS; Parkinson's disease; and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER (Tropism Redirection of AAV by Cell-type-specific Expression of RNA) adeno-associated virus, or AAV, capsid discovery platform, which we have used to generate novel capsids, or TRACER Capsids, and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly-owned, and some are advancing with licensees and collaborators including Alexion, AstraZeneca Rare Disease, or Alexion; Novartis Pharma AG, or Novartis; Neurocrine Biosciences, Inc., or Neurocrine; and Sangamo Therapeutics, Inc., or Sangamo. We focus on leveraging our expertise in capsid discovery and neuropharmacology to address the delivery hurdles that have constrained the genetic medicine and neurology disciplines, with the goal of either halting or slowing disease progression or reducing symptom severity, and therefore providing clinically meaningful impact to patients. We are advancing our own proprietary pipeline of drug candidates for neurological diseases, with a focus on AD. Our wholly-owned prioritized pipeline programs include an anti-tau antibody for AD; a superoxide dismutase 1, or SOD1, silencing gene therapy for ALS; and a tau silencing gene therapy for AD. We identified a lead development candidate for our anti-tau antibody program in the first quarter of 2023 and expect to submit an investigational new drug, or IND, application to the U.S. Food and Drug Administration, or the FDA, for this program in the first half of 2024. We believe this trial could result in the potential to generate proof-of-conc

View Full Filing

View this 10-K filing on SEC EDGAR