Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company
dedicated to advancing neurogenetic medicines, today reported
fourth quarter and full year 2023 financial and operating results.
“As of December 31, 2023, Voyager had approximately $431 million
in pro-forma cash on the balance sheet, adjusted for the Novartis
agreements and public offering in January 2024. We expect this
funding to support the generation of clinical data across multiple
programs, with the potential for significant value creation,” said
Alfred W. Sandrock, Jr., M.D., Ph.D., Chief Executive Officer of
Voyager. “We expect to advance at least four wholly-owned and
partnered programs into the clinic by the end of next year. Our
most advanced program, the anti-tau antibody VY-TAU01 for
Alzheimer’s disease, is expected to reach IND in the first half of
this year, and we anticipate generating key tau PET imaging data in
the second half of 2026.”
Key Milestones Achieved in Q4 2023 and Subsequent
Period:
- Strategic collaboration and capsid license agreement
with Novartis: In December 2023, Voyager entered into a
strategic collaboration and capsid license agreement
with Novartis Pharma AG to advance potential gene therapies
for Huntington’s disease (HD) and spinal muscular atrophy
(SMA). Novartis agreed to pay Voyager $80 million of
consideration up front and $20 million for the purchase of newly
issued equity in Voyager. Voyager is eligible to receive up to $1.2
billion in preclinical, development, regulatory and sales
milestones, as well as tiered royalties on global net sales of
products incorporating Voyager’s TRACER™ capsids.
- Completion of public offering: In January
2024, Voyager completed an underwritten public offering of shares
of its common stock (or pre-funded warrants to purchase common
stock in lieu thereof) for aggregate gross proceeds of
approximately $100 million.
- Selection of development candidate for SOD1 ALS gene
therapy program: In December 2023, Voyager announced it
selected a lead development candidate for its superoxide dismutase
1 (SOD1)-mutated amyotrophic lateral sclerosis (ALS) gene therapy
program. The Company expects to file an IND for this candidate in
mid-2025.
- Selection of development candidate for
Neurocrine-partnered Friedreich’s ataxia gene therapy
program: In February 2024, Voyager announced that the
joint steering committee with its collaborator Neurocrine
Biosciences selected a lead development candidate for the frataxin
(FXN) gene therapy program for Friedreich’s ataxia, which triggered
a $5 million milestone payment to Voyager. The companies expect the
program to enter the clinic in 2025.
- Tau silencing gene therapy program for Alzheimer’s
disease prioritized following in vivo proof-of-concept: In
February 2024, Voyager announced that a single intravenous
administration of its tau silencing gene therapy in mice expressing
human tau resulted in broad AAV distribution across multiple brain
regions and dose-dependent reductions in tau messenger RNA (mRNA)
levels of up to 90%, which were associated with robust reductions
in human tau protein levels across the brain. The data will be
presented at the upcoming 2024 International Conference on
Alzheimer’s and Parkinson’s Diseases and Related Neurological
Disorders (AD/PD™ 2024). Voyager has promoted the program to a
prioritized program within its wholly-owned pipeline and
anticipates filing an IND in 2026.
Key Upcoming Milestones:
- VY-TAU01 anti-tau antibody for Alzheimer’s
disease: Voyager expects to file an IND in first half of
2024, initiate a Phase 1a single ascending dose study in healthy
volunteers in 2024, and initiate a Phase 1b multiple ascending dose
study in patients with early Alzheimer’s disease in 2025. This
study has the potential to generate proof-of-concept data for
slowing the spread of pathological tau via tau PET imaging in
2026.
- SOD1 silencing gene therapy program for ALS:
Voyager expects to file an IND in mid-2025 and initiate a Phase 1
clinical trial in ALS patients, laying the foundation to
potentially generate proof-of-concept based on validated
biomarkers.
- Partnered programs: Voyager expects that its
collaborative partners and licensees will submit at least two IND
applications for partnered programs in Voyager’s pipeline and
initiate clinical development for the associated programs by the
end of 2025, including the FXN gene therapy program for
Friedreich’s ataxia partnered with Neurocrine Biosciences.
Fourth Quarter 2023 Financial Results
- Collaboration Revenues: Voyager had
collaboration revenue of $90.1 million for the fourth quarter of
2023, compared to $(1.6) million for the same period in 2022. The
increase was primarily due to $80.0 million in collaboration
revenue recognized during the fourth quarter of 2023 in connection
with the 2023 Novartis collaboration agreement, $5.3 million
of revenue associated with the 2023 Neurocrine collaboration
agreement, $4.6 million of revenue associated with the 2019
Neurocrine collaboration agreement, and $0.2 million of other
collaboration revenue.
- Net Income (Loss): Net income was $56.4
million for the fourth quarter of 2023, compared to net loss of
$23.6 million for the same period in 2022. The difference is
primarily due to the increase in collaboration revenue discussed
above.
- R&D Expenses: Research and development
expenses were $25.8 million for the fourth quarter of 2023,
compared to $14.6 million for the same period in 2022. The increase
in R&D expenses was primarily a result of increased
program-related spending, particularly manufacturing and
IND-enabling studies for the anti-tau antibody program and SOD1
program, along with increased Neurocrine program support, during
the fourth quarter of 2023.
- G&A Expenses: General and administrative
expenses were $10.2 million for the fourth quarter of 2023,
compared to $8.5 million for the same period in 2022. The increase
in G&A expenses was primarily a result of $1.9 million of
business development costs related to the 2023 Novartis
collaboration agreement recognized in the fourth quarter of
2023.
- Cash Position: Cash, cash equivalents and
marketable securities as of December 31, 2023, were
$230.9 million. Cash position does not include proceeds received
from the 2023 Novartis agreements and our underwritten public
offering, both of which were received after December 31, 2023.
Full Year 2023 Financial Results
- Collaboration Revenues: Voyager had
collaboration revenue of $250.0 million for the year ended
December 31, 2023, compared to $40.9 million for the same
period in 2022. The increase in collaboration revenue was the
result of $79.0 million in revenue recognized during the year ended
December 31, 2023, in connection with Novartis’ decision to
exercise two of its license options under the 2022 Novartis option
and license agreement, along with the expiration of a third
Novartis license option. In addition, during the year ended
December 31, 2023, Voyager recognized $80.0 million of revenue
associated with the 2023 Novartis collaboration agreement, $80.8
million of revenue associated with the 2023 Neurocrine
collaboration agreement, $9.8 million of revenue associated with
the 2019 Neurocrine collaboration agreement, and $0.4 million of
other collaboration revenue. During the year ended December 31,
2022, collaboration revenue was primarily related to Pfizer’s
decision, as Alexion’s predecessor in interest under the Alexion
option and license agreement, to exercise the first license option
along with the expiration of the second license option, which
resulted in revenue recognized of $40.0 million.
- Net Income (Loss): Net income was $132.3
million for the year ended December 31, 2023, compared to net loss
of $46.4 million for the same period in 2022. The difference
was primarily due to the revenue increases noted above.
- R&D Expenses: Research and development
expenses were $92.2 million for the year ended
December 31, 2023, compared to $60.8 million for the same
period in 2022. The increase in R&D expenses was primarily a
result of increased program-related spending, particularly
manufacturing and IND-enabling studies for the anti-tau antibody
program and SOD1 program, along with increased Neurocrine program
support, during the 2023 period. The increase was also a result of
increased compensation costs driven by headcount increases,
including targeted development team hires to support the advancing
pipeline, during the 2023 period.
- G&A Expenses: General and administrative
expenses were $35.8 million for the year ended
December 31, 2023, compared to $31.0 million for the same
period in 2022. The increase in G&A expenses was primarily a
result of increased compensation costs driven by headcount
increases, as well as $1.9 million of business development costs
related to the 2023 Novartis agreements recognized in the fourth
quarter of 2023.
Financial GuidanceVoyager is committed to
maintaining a strong balance sheet that supports the advancement
and growth of its platform and pipeline. Voyager continues to
assess its planned cash needs both during the current period and in
future periods. We expect our cash, cash equivalents, and
marketable securities including the cash received from the Novartis
Collaboration and Licensing Agreement and Stock Purchase Agreement,
and the completion of the public offering in January, along with
amounts expected to be received as reimbursement for development
costs under the Neurocrine and Novartis collaborations, certain
near-term milestones, and interest income, to be sufficient to meet
Voyager’s planned operating expenses and capital expenditure
requirements into 2027.
Conference CallVoyager will host a conference
call and webcast today at 4:30 p.m. ET to discuss the fourth
quarter and full year 2023 financial and operating results. To
participate via telephone and join the call live, please register
in advance here:
https://register.vevent.com/register/BIe93582a25c24475387f933ce1c5337e3.
Upon registration, telephone participants will receive a
confirmation email detailing how to join the conference call,
including the dial-in number and a unique passcode. A live webcast
of the call will also be available on the Investors section of the
Voyager website at ir.voyagertherapeutics.com, and a replay of the
call will be available at the same link approximately two hours
after its completion. The replay will be available for at least 30
days following the conclusion of the call.
About the TRACER™ Capsid Discovery
PlatformVoyager’s TRACER™ (Tropism Redirection of AAV by
Cell-type-specific Expression of RNA) capsid discovery platform is
a broadly applicable, RNA-based screening platform that enables
rapid discovery of AAV capsids with robust penetration of the
blood-brain barrier and enhanced central nervous system (CNS)
tropism in multiple species, including non-human primates (NHPs).
In preclinical studies, TRACER generated capsids have demonstrated
widespread gene expression in the CNS compared to conventional AAV
capsids as well as cell- and tissue-specific transduction,
including to areas of the brain that have been traditionally
difficult to reach, while de-targeting the liver and dorsal root
ganglia. As part of its external partnership strategy, Voyager has
established multiple collaboration agreements providing access to
its next-generation TRACER capsids to potentially enable its
partners’ gene therapy programs to treat a variety of diseases.
About Voyager TherapeuticsVoyager
Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company
dedicated to leveraging the power of human genetics to modify the
course of – and ultimately cure – neurological diseases. Our
pipeline includes programs for Alzheimer’s disease, amyotrophic
lateral sclerosis (ALS), Parkinson’s disease, and multiple other
diseases of the central nervous system. Many of our programs are
derived from our TRACER™ AAV capsid discovery platform, which we
have used to generate novel 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 partners including
Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine
Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more
information, visit www.voyagertherapeutics.com.
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 “expect,” “will,” “believe,” “anticipate,”
“potential,” “trigger” or “continue,” and other similar expressions
are intended to identify forward-looking statements.
For example, all statements Voyager makes regarding Voyager’s
ability to advance its AAV-based gene therapy programs and tau
antibody program, including expectations for Voyager’s achievement
of preclinical and clinical development milestones for its
potential development candidates such as IND filings, the
initiation of clinical trials, and generation of proof-of-concept;
Voyager’s ability to advance gene therapy product candidates under
the Neurocrine and Novartis collaborations; Voyager’s anticipated
financial results, including the anticipated receipt by Voyager of
revenues or reimbursement payments from collaboration partners; and
Voyager’s cash runway and ability to generate sufficient cash
resources to enable it to continue its business and operations 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 continued development of Voyager’s
technology platforms, including Voyager’s TRACER platform and its
antibody screening technology; the ability to initiate and conduct
preclinical studies in animal models; the development by third
parties of capsid identification platforms that may be competitive
to Voyager’s TRACER capsid discovery platform; Voyager’s ability to
create and protect intellectual property rights associated with the
TRACER capsid discovery platform, the capsids identified by the
platform, and development candidates for Voyager’s pipeline
programs; the initiation, timing, conduct and outcomes of Voyager’s
preclinical and clinical studies; the possibility or the timing of
Voyager’s receipt of program reimbursement, development or
commercialization milestones, option exercise, and other payments
under Voyager’s existing licensing or collaboration agreements; the
ability of Voyager to negotiate and complete licensing or
collaboration agreements with other parties on terms acceptable to
Voyager and the third parties; the ability to attract and retain
talented directors, employees, and contractors; and the sufficiency
of cash resources to fund its operations and pursue its corporate
objectives.
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. 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.
ContactsTrista Morrison, NACD.DC,
tmorrison@vygr.com Investors: Adam Bero, Ph.D., abero@kendallir.com
Media: Brooke Shenkin, brooke@scientpr.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: |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
Collaboration revenue |
|
$ |
90,061 |
|
$ |
(1,550 |
) |
|
$ |
250,008 |
|
|
40,907 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
25,756 |
|
|
14,551 |
|
|
|
92,172 |
|
|
60,764 |
|
|
General and administrative |
|
|
10,242 |
|
|
8,462 |
|
|
|
35,822 |
|
|
30,980 |
|
|
Total operating expenses |
|
|
35,998 |
|
|
23,013 |
|
|
|
127,994 |
|
|
91,744 |
|
|
Operating income (loss) |
|
|
54,063 |
|
|
(24,563 |
) |
|
|
122,014 |
|
|
(50,837 |
) |
|
Total other income |
|
|
3,154 |
|
|
953 |
|
|
|
11,724 |
|
|
4,445 |
|
|
Income (loss) before income taxes |
|
|
57,217 |
|
|
(23,610 |
) |
|
|
133,738 |
|
|
(46,392 |
) |
|
Income tax provision |
|
|
822 |
|
|
16 |
|
|
|
1,408 |
|
|
16 |
|
|
Net
income (loss) |
|
$ |
56,395 |
|
$ |
(23,626 |
) |
|
$ |
132,330 |
|
$ |
(46,408 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per share, basic |
|
$ |
1.28 |
|
$ |
(0.61 |
) |
|
$ |
3.08 |
|
$ |
(1.21 |
) |
|
Net
income (loss) per share, diluted |
|
|
1.25 |
|
|
(0.61 |
) |
|
|
2.97 |
|
|
(1.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding, basic |
|
|
43,983,990 |
|
|
38,547,652 |
|
|
|
43,020,747 |
|
|
38,356,810 |
|
|
Weighted-average common shares outstanding, diluted |
|
|
45,078,511 |
|
|
38,547,652 |
|
|
|
44,569,334 |
|
|
38,356,810 |
|
|
|
|
December 31, |
|
Selected Balance Sheet Items |
|
2023 |
|
2022 |
|
Cash, cash equivalents, and marketable securities |
|
$ |
230,875 |
|
$ |
118,848 |
|
Total assets |
|
$ |
351,281 |
|
$ |
159,356 |
|
Accounts payable and accrued expenses |
|
$ |
18,427 |
|
$ |
10,382 |
|
Deferred revenue |
|
$ |
75,240 |
|
$ |
65,827 |
|
Total stockholders’ equity |
|
$ |
236,320 |
|
$ |
59,020 |
|
|
|
|
|
|
|
|
|
GAAP vs. Non-GAAP Financial MeasuresVoyager’s
financial statements are prepared in accordance with generally
accepted accounting principles in the United States, or GAAP, and
represent revenue and expenses as reported to the Securities and
Exchange Commission. Voyager has provided in this release certain
financial information that has not been prepared in accordance with
GAAP, including pro-forma cash, and net collaboration revenue and
net research and development expenses, the latter two of which
exclude the impact of reimbursement by Neurocrine Biosciences
(Neurocrine) for expenses we incur in conducting preclinical
development activities under our collaboration agreements.
Management uses these non-GAAP measures to evaluate the Company’s
operating performance in a manner that allows for meaningful
period-to-period comparison and analysis of trends in its business.
Management believes that such non-GAAP measures are important in
comparing current results with prior period results and are useful
to investors and financial analysts in assessing the Company’s
operating performance. Non-GAAP financial measures are not required
to be uniformly applied, are not audited and should not be
considered in isolation. The non-GAAP measures give investors and
financial analysts a better understanding of our net revenue and
net research and development expenses without the pass-through
impact of Neurocrine costs. The non-GAAP financial information
presented here should be considered in conjunction with, and not as
a substitute for, the financial information presented in accordance
with GAAP. Investors are encouraged to review the reconciliation of
these non-GAAP measures to their most directly comparable GAAP
financial measures set forth below.
The Company’s pro-forma cash as of December 31, 2023, was $431
million which includes $230.9 million of cash, cash equivalents,
and marketable securities as of December 31, 2023, as adjusted for
the gross proceeds received from the 2023 Novartis collaboration
agreement and our underwritten public offering in January 2024.
This does not include any costs associated with executing the
Novartis collaboration or the public offering.
Reconciliation of GAAP to Non-GAAP Measures |
(in thousands) |
|
|
Three Months Ended |
|
YTD |
|
|
December 31, |
|
December 31, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
GAAP collaboration revenue |
|
$ |
90,061 |
|
$ |
(1,550 |
) |
|
$ |
250,008 |
|
$ |
40,907 |
Revenue recognized for reimbursed research and development services
(Note 1) |
|
$ |
3,052 |
|
$ |
257 |
|
|
$ |
10,095 |
|
$ |
836 |
Net
collaboration revenue |
|
$ |
87,009 |
|
$ |
(1,807 |
) |
|
$ |
239,913 |
|
$ |
40,071 |
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP total research and development expenses |
|
$ |
25,756 |
|
$ |
14,551 |
|
|
$ |
92,172 |
|
$ |
60,764 |
Expenses incurred for reimbursed research and development services
(Note 1) |
|
$ |
3,052 |
|
$ |
257 |
|
|
$ |
10,095 |
|
$ |
836 |
Net
research and development expenses |
|
$ |
22,704 |
|
$ |
14,294 |
|
|
$ |
82,077 |
|
$ |
59,928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 1: Under the Company's existing collaboration agreements
with Neurocrine, Neurocrine has agreed to be responsible for all
costs the Company incurs in conducting preclinical development
activities for each Neurocrine collaboration program, in accordance
with joint steering committee agreed upon workplans and budgets.
Reimbursable research and development services performed during the
period are captured within collaboration revenue and research and
development expenses in the Company's consolidated statements of
operations. During the three and twelve months ended December 31,
2023, we incurred $3.1 million and $10.1 million, respectively, of
reimbursable research and development services recorded within
collaboration revenue and research and development expenses. During
the three and twelve months ended December 31, 2022, we incurred
$0.3 million and $0.8 million, respectively, of reimbursable
research and development services recorded within collaboration
revenue and research and development expenses.
Voyager Therapeutics (NASDAQ:VYGR)
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Voyager Therapeutics (NASDAQ:VYGR)
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