UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported): March 14, 2018

 

 

Voyager Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

Registrant’s telephone number, including area code (857) 259-5340

 

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

 

 

 

Item 2.02. Results of Operations and Financial Condition.

On March 14, 2018, Voyager Therapeutics, Inc. (the “Company”) announced financial results for the fourth quarter and full year 2017. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits

(d)    Exhibits

 

The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:

 

 

EXHIBIT INDEX

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Voyager Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results

 

VY-AADC for advanced Parkinson’s disease on track for start of planned global, pivotal Phase 2-3 program during the middle of this year

 

Two IND filings expected from the ALS, Huntington’s disease and Friedreich’s ataxia programs for 2019 

 

Recent AbbVie collaboration successfully leveraged Voyager’s gene therapy platform and expertise and strengthened the balance sheet to extend cash runway into early 2020

   

 

Cambridge, Mass., March 14, 2018 – Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases today reported its fourth quarter and full year 2017 financial results, provided corporate highlights, goals and financial guidance and will host a conference call and webcast today at 8:00 a.m. ET to discuss these results.

 

“Our strong performance in 2017 was underscored by advancing our lead program VY-AADC for advanced Parkinson’s disease including successfully manufacturing our gene therapy product candidate using our baculovirus/Sf9 cell process and  commercial-scale GMP runs, completing our dose-ranging Phase 1b clinical trial as well as our posterior trajectory trial to select both an optimal dose and delivery protocol for the planned pivotal trial, and reporting longer-term Phase 1b data with clinically meaningful and durable responses with this one-time treatment,” said Steven Paul, M.D., president and chief executive officer of Voyager Therapeutics. “This performance sets us up to initiate a planned pivotal program in the middle of this year, moving this potential treatment closer to the hundreds of thousands of advanced Parkinson’s disease patients who require better control of their motor function in order to improve their quality of life.  Our preclinical pipeline targeting other severe neurological diseases continues to advance towards the clinic and with our recently announced collaboration with AbbVie, we continue to successfully leverage our gene therapy platform and expertise towards an exciting new area of vectorized immunotherapy initially to deliver monoclonal antibodies directed against tau for the treatment of Alzheimer’s disease and related neurodegenerative diseases.”

 

2017 and Recent Key Pipeline and Corporate Highlights

 

 

 

 

   

 

 

 

 

Corporate Goals and 2018 Financial Guidance

 

Voyager is committed to becoming the leading gene therapy company focused on severe neurological diseases with expertise in discovery, development, manufacturing and commercialization of gene therapy products for people living with these devastating diseases. During 2018, Voyager plans to achieve the following corporate goals towards fulfilling this commitment:

 

 

 

 

 

 

 

 

Fourth Quarter and Full Year 2017 Financial Results

 

For the fourth quarter and full year of 2017, Voyager reported:

 

A GAAP net loss of $11.8 million, or $0.40 per share, for the fourth quarter ended December 31, 2017, compared to a GAAP net loss of $14.7 million, or $0.57 per share, for the same period in 2016.  The Company reported a GAAP net loss of $70.7 million, or $2.64 per share, for the full year ended December 31, 2017, compared to a net loss of $40.2 million, or $1.59 per share, for the same period in 2016.

 

Collaboration revenues of $6.3 million for the fourth quarter of 2017 compared to collaboration revenues of $2.4 million for the fourth quarter of 2016.  Collaboration revenues of $10.1 million for the full year ended December 31, 2017 compared to collaboration revenues of $14.2 million for the full year ended December 31, 2016.  Collaboration revenues reflect recognition of payment for research and development services provided by Voyager for various programs under the Sanofi Genzyme collaboration agreement.  Collaboration revenues can vary based on quarterly assessments of expected or anticipated efforts under the collaboration.  The increase in collaboration revenues for the fourth quarter 2017 compared to the same period in 2016 reflect revenue recognition as a result of Sanofi Genzyme’s decision not to exercise its option to the ex-U.S. rights to the Parkinson’s disease program and Voyager’s recognition of the portion of the agreement allocated to that license option. The decrease in collaboration revenues for the full year 2017 compared to the same period in 2016 reflects the change in the estimated period for reaching development milestones for certain preclinical programs under the collaboration agreement.

 

Research and development (R&D) expenses of $13.3 million for the fourth quarter ended December 31, 2017 compared to $12.7 million for the same period in 2016.  R&D expenses of $62.3 million for the year ended December 31, 2017 compared to $42.2 million for the same period in 2016. The increase in R&D expenses related primarily to expenditures associated with the development of Voyager’s pipeline including the ongoing Phase 1 trial

for VY-AADC, and increased personnel and facility costs to support the advancement of the pipeline programs.

 

General and administrative (G&A) expenses of $5.4 million for the fourth quarter ended December 31, 2017 compared to $3.5 million for the same period in 2016.  G&A expenses of $19.7 million for the year ended December 31, 2017 compared to $13.3 million for the same period in 2016.  The increase in G&A expenses was primarily due to personnel and facility costs to support Voyager’s pipeline programs.

 

Cash, cash equivalents, and marketable debt securities as of December 31, 2017 were $169.1 million.

 

Conference Call Information

 

Voyager will host a conference call and webcast today at 8:00 a.m. ET.  The live call may be accessed by dialing (877) 851-3834 for domestic callers or +1 (631) 291-4595 for international callers and referencing conference ID number 3688788.  A live audio webcast of the conference call will be available online from the Investors & Media section of Voyager’s website at www.voyagertherapeutics.com.  The webcast will be archived for 30 days.

 

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 pipeline focuses on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of ALS called SOD1, Huntington’s disease, Friedreich’s ataxia, and neurodegenerative diseases related to defective or excess aggregation of tau protein in the brain including Alzheimer’s disease and severe, chronic pain. Voyager has broad strategic collaborations with Sanofi Genzyme, the specialty care global business unit of Sanofi, AbbVie, and the University of Massachusetts Medical School.  Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager Therapeutics is headquartered in Cambridge, Massachusetts. For more information, please visit www.voyagertherapeutics.com. 

 

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 its CEO transition plans,  the initiation, timing, progress and reporting of results of its preclinical programs and clinical trials and its research and development programs, its ability to advance its AAV-based gene therapies into, and successfully initiate, enroll and complete,

clinical trials, the potential clinical utility of its product candidates, its ability to continue to develop its product engine, its ability to develop manufacturing capability for its products and successfully transition its manufacturing process, its ability to perform under existing collaborations with, among others, Sanofi Genzyme and AbbVie and to add new programs to its pipeline, its ability to enter into new partnerships or collaborations, its expected cash, cash equivalents and marketable debt securities at the end of a fiscal period and anticipation for how long expected cash, cash equivalents and marketable debt securities will last, and the timing or likelihood of its regulatory filings and approvals, are forward looking. All forward-looking statements are based on estimates and assumptions by Voyager’s management that, although Voyager believes 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, those related to the search for a new CEO; the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the expectations for regulatory submissions and approvals; the continued development of the product engine; Voyager’s scientific approach and general development progress; the availability or commercial potential of Voyager’s product candidates; the sufficiency of cash resources; need for additional financing; and the possibility and timing of Voyager’s partner’s exercise of their options to the collaboration programs. These statements are also subject to a number of material risks and uncertainties that are described in Voyager’s most recent 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. Any forward-looking statement speaks only as of the date on which it was made.  Voyager undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

 

 

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Investor Relations:

Matt Osborne

Vice President of Investor Relations & Corporate Communications

857-259-5353

mosborne@vygr.com  

 

Media:

Katie Engleman

Pure Communications, Inc.

910-509-3977

Katie@purecommunicationsinc.com

Selected Financial Information

($-amounts in thousands, except per share data)

(Unaudited)