Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company
dedicated to breaking through barriers in gene therapy and
neurology, today reported third quarter 2023 financial and
operating results.
“Voyager continues to advance our prioritized programs towards
the clinic: the initiation of GLP toxicology studies for our
anti-tau antibody VY-TAU01 keeps us on track for an anticipated IND
filing in the first half of 2024. Further, we expect to select a
development candidate for our wholly-owned SOD1 ALS gene therapy
program by end-of-year, and our broader gene therapy pipeline
presents multiple opportunities for INDs in 2025 across our
wholly-owned and partnered programs,” said Alfred W. Sandrock, Jr.,
M.D., Ph.D., Chief Executive Officer of Voyager. “In addition to
advancing our pipeline, we continue to evolve and refine our
neurotropic TRACER AAV capsids and look forward to continuing to
share data at scientific meetings.”
Key Milestones Achieved in Q3 2023 and Subsequent
Period:
- Advancement of anti-tau
antibody program: Voyager initiated Good Laboratory
Practice (GLP) toxicology studies to support the investigational
new drug (IND) filing of VY-TAU01, its humanized anti-tau antibody.
The Company expects to file an IND for the program in the first
half of 2024.
- Capsid license agreement assigned to Alexion,
AstraZeneca Rare Disease: In September, Alexion,
AstraZeneca Rare Disease, announced it had completed a definitive
purchase and license agreement for a portfolio of preclinical rare
disease gene therapy programs and enabling technologies from Pfizer
Inc. The portfolio includes the license for a novel capsid
generated from Voyager's TRACER™ capsid discovery platform to
enable a potential gene therapy program against an undisclosed rare
neurologic disease target. The assignment of the license does not
impact the terms of the licensing agreement.
Key Upcoming Milestones:
- VY-TAU01 anti-tau antibody program for Alzheimer’s disease:
Voyager expects to file an IND in the first half of 2024.
- SOD1 gene therapy program for amyotrophic lateral sclerosis
(ALS): Voyager expects to identify a lead development candidate in
2023 to support an IND in mid-2025.
- Voyager and Neurocrine Biosciences collaboration: Voyager and
Neurocrine Biosciences continue to collaboratively advance the GBA1
gene therapy program for Parkinson’s disease and other
GBA1-mediated diseases, as well as the FXN gene therapy program for
Friedreich’s Ataxia.
Third Quarter 2023 Financial Results
- Collaboration Revenues: Voyager had
collaboration revenue of $4.6 million for the third quarter of
2023, compared to $41.1 million for the same period in 2022. The
decrease was primarily due to $40.0 million in collaboration
revenue recognized during the third quarter of 2022 in connection
with Pfizer exercising its option to license a novel
capsid generated from the TRACER capsid discovery
platforms.
- Net (Loss)
Income: Net loss was $25.9 million for the third quarter
of 2023, compared to net income of $17.6 million for the same
period in 2022. The difference is primarily due to the
decrease in collaboration revenue discussed above.
- R&D Expenses: Research and development
expenses were $25.9 million for the third quarter of 2023, compared
to $19.3 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, along with
increased Neurocrine program support, during the third quarter of
2023. 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 third
quarter of 2023.
- G&A Expenses: General and administrative
expenses were $8.3 million for the third quarter of 2023, compared
to $7.3 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.
- Cash Position: Cash, cash equivalents and
marketable securities as of September 30, 2023, were $252.9
million.
Nine Months Ended September 30, 2023, Financial
Results
- Collaboration Revenues: Voyager had
collaboration revenue of $159.9 million for the nine months ended
September 30, 2023 period, compared to $42.5 million for the same
period in 2022. The increase was primarily due to revenue
recognized during the first quarter of 2023 on the
2023 strategic collaboration with Neurocrine Biosciences, as
well as revenue recognized on the Novartis license of novel TRACER
capsids.
- Net Income
(Loss): Net income was $75.9 million for the nine months
ended September 30, 2023 period, compared to net loss of $22.8
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 $66.4 million for the nine months ended September 30,
2023 period, compared to $46.2 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, 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 $25.6 million for the nine months ended September 30,
2023 period, compared to $22.5 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.
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 and in future periods. We
expect our cash, cash equivalents, and marketable securities, along
with amounts expected to be received as reimbursement for
development costs under the Neurocrine collaborations and interest
income, to be sufficient to meet Voyager’s planned operating
expenses and capital expenditure requirements into mid-2025.
Conference Call Voyager will host a conference
call and webcast today at 4:30 p.m. ET to discuss the third quarter
2023 financial and operating results. To participate via telephone
and join the call live, please register in advance here. 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).
TRACER generated capsids have demonstrated superior and 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 (Nasdaq: VYGR) is a biotechnology company dedicated to
breaking through barriers in gene therapy and neurology. The
potential of both disciplines has been constrained by delivery
challenges; Voyager is leveraging cutting-edge expertise in capsid
discovery and deep neuropharmacology capabilities to address these
constraints. Voyager’s TRACER™ AAV capsid discovery platform has
generated novel capsids with high target delivery and blood-brain
barrier penetration at low doses, potentially addressing the narrow
therapeutic window associated with conventional gene therapy
delivery vectors. This platform is fueling alliances with Alexion,
AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine
Biosciences, Inc. and Sangamo Therapeutics, Inc., as well as
multiple programs in Voyager’s own pipeline. Voyager’s pipeline
includes wholly-owned and collaborative preclinical programs in
Alzheimer’s disease, amyotrophic lateral sclerosis (ALS),
Parkinson’s disease, and other diseases of the central nervous
system, with a focus on validated targets and biomarkers to enable
a path to rapid potential proof-of-biology. For more information,
visit www.voyagertherapeutics.com.
Voyager Therapeutics® is a registered trademark, and TRACER™ is
a trademark, of Voyager Therapeutics, Inc.
Forward-Looking StatementsThis 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,” “plan,” “believe,” “target,” “potential,” or
“continue,” and other similar expressions are intended to identify
forward-looking statements.
For example, all statements Voyager makes regarding Voyager’s
ability to continue to evolve and refine its neurotropic TRACER AAV
capsids; Voyager’s ability to advance its AAV-based gene therapy
programs and tau antibody program, including the preclinical
development of its potential development candidates and timing of
IND filings; Voyager’s ability to advance gene therapy product
candidates under the Neurocrine collaborations; Voyager’s
anticipated financial results, including the receipt by Voyager of
revenues or reimbursement payments from collaboration partners; and
Voyager’s cash runway and Voyager’s 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 studies; the possibility or the timing of the exercise
of development, commercialization, license and other options under
the Pfizer and Novartis license option agreements and Neurocrine
collaborations; 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.
Contacts
InvestorsInvestors@vygr.comAndrew
Funderburkafunderburk@kendallir.com
MediaTrista Morrisontmorrison@vygr.comPeg
Rusconiprusconi@vergescientific.com
|
Selected Financial Information($ amounts in
thousands, except per share data) (Unaudited) |
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
Statement of
Operations Items: |
|
2023 |
|
|
2022 |
|
2023 |
|
2022 |
|
Collaboration revenue |
|
$ |
4,614 |
|
|
$ |
41,086 |
|
$ |
159,947 |
|
$ |
42,457 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
25,863 |
|
|
|
19,337 |
|
|
66,416 |
|
|
46,213 |
|
General and administrative |
|
|
8,258 |
|
|
|
7,307 |
|
|
25,580 |
|
|
22,518 |
|
Total operating expenses |
|
|
34,121 |
|
|
|
26,644 |
|
|
91,996 |
|
|
68,731 |
|
Operating (loss) income |
|
|
(29,507 |
) |
|
|
14,442 |
|
|
67,951 |
|
|
(26,274 |
) |
Total other income |
|
|
3,429 |
|
|
|
3,182 |
|
|
8,570 |
|
|
3,492 |
|
(Loss) income before income
taxes |
|
|
(26,078 |
) |
|
|
17,624 |
|
|
76,521 |
|
|
(22,782 |
) |
Income tax (benefit)
provision |
|
|
(177 |
) |
|
|
— |
|
|
586 |
|
|
— |
|
Net (loss) income |
|
$ |
(25,901 |
) |
|
$ |
17,624 |
|
$ |
75,935 |
|
$ |
(22,782 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per share,
basic |
|
$ |
(0.59 |
) |
|
$ |
0.46 |
|
$ |
1.85 |
|
$ |
(0.59 |
) |
Net (loss) income per share,
diluted |
|
$ |
(0.59 |
) |
|
$ |
0.45 |
|
$ |
1.78 |
|
$ |
(0.59 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding, basic |
|
|
43,864,838 |
|
|
|
38,507,542 |
|
|
40,962,116 |
|
|
38,292,497 |
|
Weighted-average common shares
outstanding, diluted |
|
|
43,864,838 |
|
|
|
39,570,394 |
|
|
42,610,724 |
|
|
38,292,497 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
Selected Balance Sheet
Items |
|
2023 |
|
2022 |
Cash, cash equivalents, and
marketable debt securities |
|
$ |
252,936 |
|
|
$ |
118,848 |
|
Total assets |
|
$ |
294,653 |
|
|
$ |
159,356 |
|
Accounts payable and accrued
expenses |
|
$ |
14,321 |
|
|
$ |
10,382 |
|
Deferred revenue |
|
$ |
82,087 |
|
|
$ |
65,827 |
|
Total stockholders’
equity |
|
$ |
176,220 |
|
|
$ |
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 net collaboration revenue and net research and
development expenses, both of which exclude the impact of
reimbursement by Neurocrine Biosciences (Neurocrine) for expenses
we incur in conducting pre-clinical 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP Measures |
(in thousands) |
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
GAAP collaboration
revenue |
|
$ |
4,614 |
|
|
$ |
41,086 |
|
|
$ |
159,947 |
|
|
$ |
42,457 |
|
Revenue recognized for reimbursed research and development services
(Note 1) |
|
$ |
3,678 |
|
|
$ |
225 |
|
|
$ |
7,030 |
|
|
$ |
579 |
|
Net collaboration revenue |
|
$ |
936 |
|
|
$ |
40,861 |
|
|
$ |
152,917 |
|
|
$ |
41,878 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP total research and
development expenses |
|
$ |
25,863 |
|
|
$ |
19,337 |
|
|
$ |
66,416 |
|
|
$ |
46,213 |
|
Expenses incurred for reimbursed research and development services
(Note 1) |
|
$ |
3,678 |
|
|
$ |
225 |
|
|
$ |
7,030 |
|
|
$ |
579 |
|
Net research and development
expenses |
|
$ |
22,185 |
|
|
$ |
19,112 |
|
|
$ |
59,386 |
|
|
$ |
45,634 |
|
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 pre-clinical 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 nine months ended September 30,
2023, we incurred $3.7 million and $7.0 million, respectively, of
reimbursable research and development services recorded within
collaboration revenue and research and development expenses. During
the three and nine months ended September 30, 2022, we incurred
$0.2 million and $0.6 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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