Full Press Release Details
Voyager Therapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Corporate Updates
CAMBRIDGE, Mass., February 25, 2021 - Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for patients suffering from severe neurological diseases, today reported its fourth quarter and full year 2020 financial results and provided corporate updates.
"We have made significant progress readying our lead wholly owned program, VY-HTT01 for Huntington's disease, for clinical trials," said Andre Turenne, President and CEO of Voyager. "We have also continued to advance our preclinical portfolio, including our innovative vectorized antibodies, and have achieved highly promising results with our TRACER platform to identify viral capsids that can cross the blood-brain barrier. With these developments, we look forward to initiating a new phase in our mission to deliver transformative therapies for those affected with severe neurological diseases."
Recent Corporate Updates
Selected 2020 Corporate Highlights
Selected Anticipated 2021 Corporate Milestones
Fourth Quarter and Full Year 2020 Financial Results
About Voyager Therapeutics
Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV gene therapy through innovation and investment in vector engineering and optimization, manufacturing, and dosing and delivery techniques. Voyager's wholly owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinson's disease, Huntington's disease, Friedreich's ataxia, and other severe neurological diseases. For more information on Voyager Therapeutics, please visit the company's website at www.voyagertherapeutics.com or follow @VoyagerTx on Twitter and LinkedIn.
Voyager Therapeutics is a registered trademark, and TRACER is a trademark, of Voyager Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "might," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "undoubtedly," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding the initiation, timing, progress, activities, goals and reporting of results of its preclinical programs and clinical
trials and its research and development programs; the ability and timing for completing clinical evaluations and furnishing information to the FDA in connection with the clearance of IND applications, including specifically Voyager's ability to furnish a complete response to the FDA in the first half of 2021 and to initiate its clinical evaluation of VY-HTT01 upon resolution of the clinical hold and the clearance of the IND application; the efforts and progress of collaboration partners to complete assessments and to respond to regulatory requests, including specifically Neurocrine's ability to provide additional imaging data for and to complete clinical assessments of study participants in the VY-AADC (NBIb-1817) program as requested by the DSMB prior to August 2, 2021, and Voyager's intent and ability to support Neurocrine in such efforts; Voyager's ability to determine a path forward for the VY-AADC (NBIb-1817) program; the future operation of the collaboration agreement with Neurocrine Biosciences; Voyager's ability to present preclinical data on its early pipeline progress and novel capsid discovery efforts in non-human primates at scientific meetings and other presentations in the first half of 2021; Voyager's ability to advance AAV-based gene therapies into, and to initiate, enroll and complete, clinical trials; Voyager's ability to continue to develop its novel AAV capsid development program; the regulatory pathway of, and the timing or likelihood of its regulatory filings and approvals for, any of Voyager's product candidates; Voyager's ability to add new programs to its pipeline; Voyager's anticipated financial results, including the receipt by Voyager of revenues or reimbursement payments from collaboration partners; Voyager's operating expenses, available cash, cash equivalents and marketable debt securities and Voyager's ability to fund its operating expenses with its current cash, cash equivalents and marketable debt securities through a stated time period, in each instance are forward looking. All forward-looking statements are based on estimates and assumptions by Voyager's management that, although Voyager believes such forward-looking statements to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected. Such risks and uncertainties include, among others, the severity and length of the COVID-19 health crisis; the initiation and conduct of preclinical studies and clinical trials; the ability and efforts of collaboration partners complete and achieve program objectives; the availability of data from preclinical studies and clinical trials; the expectations for regulatory communications, submissions and approvals; the continued development of the gene therapy platform and Voyager's TRACER system; Voyager's scientific approach and general development progress; the ability to attract and retain talented contractors and employees; the ability to create and protect intellectual property; the sufficiency of cash resources; the possibility or the timing of the exercise of development, commercialization, license and other options under collaborations; the ability of Neurocrine to meet the information requests of, and to resolve the questions raised by, the DSMB regarding the RESTORE-1 clinical trial; and the availability or commercial potential of Voyager's product candidates. These statements are also subject to a number of material risks and uncertainties that are described in Voyager's Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. All information in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
Selected Financial Information
($-amounts in thousands, except per share data)
| Three Months Ended | Year Ended | ||||||||||||
| December 31, | December 31, | ||||||||||||
| Statement of Operations Items: | 2020 | 2019 | 2020 | 2019 | |||||||||
| Collaboration revenue | $ | 6,537 | $ | 32,674 | $ | 171,128 | 104,391 | ||||||
| Operating expenses: | |||||||||||||
| Research and development | 21,997 | 36,551 | 108,754 | 119,735 | |||||||||
| General and administrative | 8,270 | 9,891 | 34,991 | 36,335 | |||||||||
| Total operating expenses | 30,267 | 46,442 | 143,745 | 156,070 | |||||||||
| Operating (loss) income | (23,730) | (13,768) | 27,383 | (51,679) | |||||||||
| Total other income | 7,802 | 1,193 | 9,357 | 8,082 | |||||||||
| Net (loss) income | $ | (15,928) | $ | (12,575) | $ | 36,740 | $ | (43,597) | |||||
| Net (loss) income per share, basic | $ | (0.43) | $ | (0.34) | $ | 0.99 | $ | (1.21) | |||||
| Net (loss) income per share, diluted | (0.43) | (0.34) | 0.98 | (1.21) | |||||||||
| Weighted-average common shares outstanding, basic | 37,290,259 | 36,838,507 | 37,132,447 | 35,898,266 | |||||||||
| Weighted-average common shares outstanding, diluted | 37,290,259 | 36,838,507 | 37,348,514 | 35,898,266 |
| December 31, | |||||||
| Selected Balance Sheet Items | 2020 | 2019 | |||||
| Cash, cash equivalents, and marketable debt securities | $ | 174,782 | $ | 281,533 | |||
| Total assets | $ | 261,584 | $ | 354,760 | |||
| Accounts payable and accrued expenses | $ | 14,839 | $ | 25,586 | |||
| Deferred revenue | $ | 43,817 | $ | 194,493 | |||
| Total stockholders' equity | $ | 154,320 | $ | 99,512 |