Voyager Therapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Corporate Updates
February 25 2021 - 4:01PM
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
- The Investigational New Drug (IND) application for VY-HTT01 for
the treatment of Huntington’s disease remains on clinical hold by
the U.S. Food and Drug Administration (FDA) pending the resolution
of additional information requests regarding specific chemistry,
manufacturing and controls (CMC) topics, including drug device
compatibility and drug substance and product characterization.
Voyager plans to provide its complete response to the FDA in the
first half of 2021 and to initiate its clinical evaluation of
VY-HTT01 subject to and upon resolution of the clinical hold and
the clearance of the IND application.
- In December 2020, Voyager published a peer-reviewed manuscript
in Molecular Therapy Methods & Clinical Development entitled
“Rapid Evolution of Blood-Brain Barrier-Penetrating AAV Capsids by
RNA-Driven Biopanning” which describes the foundational
proof-of-concept experiments for Voyager’s proprietary TRACER™
platform. Voyager is leveraging the TRACER platform to facilitate
the selection of AAV capsids with significantly improved
blood-brain barrier crossing and cell-specific transduction
properties for therapeutic applications.
- The RESTORE-1 Phase 2 clinical trial for VY-AADC (NBIb-1817)
remains on FDA clinical hold. The program was placed on clinical
hold in December 2020 and followed the submission
by Neurocrine Biosciences, Inc. of an IND Safety Report
related to the observation of magnetic resonance imaging
abnormalities in RESTORE-1 study participants. The clinical
implications of this observation are currently unknown and are
being evaluated. The Data Safety Monitoring Board (DSMB) has
requested additional imaging data and clinical assessments.
- In February 2021, Voyager announced that Neurocrine decided to
terminate that portion of the collaboration agreement related to
the VY-AADC (NBIb-1817) program, effective August 2, 2021. Voyager
intends to support Neurocrine, the study sponsor and IND holder, on
ongoing matters related to the completion of imaging and clinical
assessments requested by the DSMB and the provision of other
information requested by the FDA for the RESTORE-1 Phase 2 clinical
trial.
- In January 2021, Voyager hired Robin Swartz as Senior Vice
President of Program Management and Patient Engagement. Robin
brings more than twenty years of experience across the industry
serving most recently as Vice President, Patient and Product
Services for Rare Diseases at Sanofi Genzyme.
Selected 2020 Corporate Highlights
- 14 data
presentations covering multiple program and pipeline activities at
the American Society of Gene and Cell
Therapy (ASGCT) Annual Meeting in May 2020.
- 4 publications in
peer-reviewed journals on our efforts in Huntington’s disease,
Parkinson’s disease, gene therapy delivery and manufacturing.
- Presentation at the
Movement Disorder Society (MDS) Virtual Congress in September 2020
of three-year data of VY-AADC (NBIb-1817) in a dose-escalating
Phase 1b study and two-year data in a Phase 1b study using a
posterior trajectory.
- Completion and
occupancy of a 30,000 square foot, state-of-the-art process
research and development facility in Lexington, Massachusetts, to
enable manufacturing of AAV gene therapy vectors at laboratory and
pilot scale.
- Appointment
of Nancy Vitale as an independent director to Voyager’s
Board of Directors.
- Appointments of
leaders across key functional areas, including Maria
Lopez-Bresnahan as Senior Vice President, Head of Translational
Medicine and Clinical Development; Michelle Quinn Smith as
Chief Human Resources Officer; and Diana M. Collazo, Ph.D.,
J.D. as Chief Patent Counsel.
Selected Anticipated 2021 Corporate
Milestones
- Voyager plans to provide a complete response to the additional
requests from the FDA regarding the IND application for VY-HTT01 in
the first half of 2021. Voyager expects to initiate clinical
evaluation of VY-HTT01 subject to and upon resolution of the
clinical hold and the clearance of the IND application.
- Voyager expects to provide preclinical data on its early
pipeline progress as well as its novel capsid discovery efforts in
non-human primates at scientific meetings and other presentations
in the first half of 2021.
- Voyager plans to determine the potential path forward for the
VY-AADC (NBIb-1817) program based on the additional information
being collected by Neurocrine in response to the DSMB
requests.
Fourth Quarter and Full Year 2020 Financial
Results
- Collaboration Revenues: Voyager had
collaboration revenue of $6.5 million for the fourth quarter of
2020 and $171.1 million for the year ended December 31, 2020,
compared to collaboration revenue of $32.7 million and $104.4
million, respectively, for the same periods of 2019. The decrease
in collaboration revenue in the fourth quarter of 2020 compared to
the same period in 2019 was largely due to a reduction of revenue
related to research services and cost reimbursements from the
collaborations with Neurocrine and AbbVie. Full year 2020 revenue
includes $105.2M related to the recognition of remaining deferred
revenue for AbbVie upon the termination of the collaboration. All
research services related to the AbbVie collaborations were
completed prior to the fourth quarter of 2020.
- Net Income/Loss: Net loss was $15.9 million
for the fourth quarter of 2020 and net income was $36.7 million for
the year ended December 31, 2020, compared to a net loss of $12.6
million and $43.6 million, respectively, for the same periods of
2019.
- R&D Expenses: Research and development
expenses were $22.0 million for the fourth quarter of 2020,
compared to $36.6 million for the same period in 2019. For the year
ended December 31, 2020, R&D expenses were $108.8 million,
compared to $119.7 million for the same period of 2019. The
decrease in R&D expenses was primarily related to lower
external costs for services supporting our clinical and preclinical
pipeline programs.
- G&A Expenses: General and administrative
expenses were $8.3 million for the fourth quarter of 2020, compared
to $9.9 million for the same period in 2019. For the year ended
December 31, 2020, G&A expenses were $35.0 million, compared to
$36.3 million for the same period of 2019. The decrease in G&A
expenses was primarily related to a reduction in legal and
professional fees.
- Cash Position: Cash, cash equivalents and
marketable debt securities as of December 31, 2020 were $174.8
million.
Financial Guidance
- Based on the Company’s current operating plan and excluding any
potential financing or business development activities in 2021,
Voyager anticipates cash, cash equivalents and marketable debt
securities will be between $50 million and $60 million at the end
of 2021.
- Voyager expects that its cash, cash equivalents and marketable
debt securities, as well as amounts expected to be received as
reimbursement of development costs from Neurocrine, will be
sufficient to meet Voyager’s planned operating expenses and capital
expenditure requirements into mid-2022.
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.
Investors: investors@voyagertherapeutics.com
Media: Sheryl
Seapy W2Opure949-903-4750sseapy@purecommunications.com
Selected Financial
Information($-amounts in thousands, except per share
data)(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
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