Voyager Therapeutics Reports Fourth Quarter and Full Year 2021 Financial and Operating Results
08 Março 2022 - 8:16AM
Voyager Therapeutics, Inc. (Nasdaq: VYGR), a gene therapy company
developing life-changing treatments and next-generation
adeno-associated virus (AAV) capsids, today reported fourth quarter
and full year 2021 financial and operating results.
“We’re extremely pleased with the value created by our
TRACER™ capsid discovery platform, evidenced by the two major
license option agreements with Novartis and Pfizer for
target-specific access to our highly differentiated capsids, which
affords us the opportunity to expand the impact of our technology
through external program development by our partners. The potential
of our novel TRACER capsids to improve transduction in target
tissues and to minimize off target toxicities associated with
conventional AAV delivery may enable a new wave of gene therapies
to treat serious diseases,” said Michael Higgins, interim CEO of
Voyager. “We’ve also made important additions to our leadership
team with Al Sandrock joining our Board and its Executive
Committee, and the promotion of Robin Swartz to chief operating
officer. We continue to leverage our proprietary AAV capsids to
progress our pipeline and look forward to sharing new preclinical
data from select programs and our TRACER platform at a medical
conference this spring.”
Target-Specific License Option Agreement with Novartis
Expands Applications of TRACER Capsids
- Voyager today announced a license option agreement with
Novartis AG (NYSE: NVS) through which Novartis may exercise options
to license novel AAV capsids generated from Voyager’s RNA-driven
TRACER (Tropism Redirection of AAV by Cell-type-specific Expression
of RNA) capsid discovery platform for potential use with three
undisclosed CNS targets and options to access capsids for two
additional targets to be agreed on in the future, subject to
availability. These targets are distinct from those being explored
in Voyager’s internal pipeline and other licensing agreements.
Voyager retains global rights to its TRACER discovery platform and
all capsids arising from it, subject to certain obligations under
its agreement with Pfizer, as detailed below.
- Voyager will receive $54 million up front and is entitled to
receive up to $37.5 million in exercise fees for three initial CNS
targets, exercisable by Novartis within 12 months of signing. In
addition, Novartis may elect to evaluate capsids for up to two
additional targets, to be agreed upon in the future, subject to
availability, for $18 million upon selection of each target, and a
$12.5 million exercise fee for selection of a capsid for each
target. Voyager is also eligible to earn up to $1.5 billion in
total development, regulatory, and commercial milestones for
products utilizing Voyager-licensed capsids, as well as mid- to
high-single-digit tiered royalties based on net sales of Novartis
products incorporating the licensed capsids.
Transgene-Specific License Option Agreement with Pfizer
Supports CNS and Cardiac Applications for TRACER
- In October, Voyager and Pfizer Inc. (NYSE: PFE) announced a
license option agreement through which Pfizer may exercise options
to license AAV capsids generated from the TRACER platform. Under
the terms of the agreement, Pfizer received target-specific access
to Voyager’s TRACER capsids for one CNS and one cardiovascular
target and the right to exercise options to license capsids for
exclusive use in Pfizer’s development of AAV gene therapies for
each target. Voyager retains global rights to all TRACER capsids
for use with other targets and to all other applications of its
TRACER technology.
- Voyager received $30 million upfront and is entitled to receive
up to $20 million in exercise fees in aggregate for two options
exercisable by Pfizer within 12 months of signing, and is eligible
to earn up to $580 million in total development, regulatory, and
commercial milestones, as well as mid- to high-single-digit tiered
royalties based on net sales of Pfizer products incorporating the
licensed capsids.
Additional Data from Evolving TRACER AAV9 and AAV5
Capsid Portfolio Planned for Spring Medical Conference
- Voyager continues to perform screening campaigns with its
TRACER capsid discovery platform to identify additional proprietary
AAV9- and AAV5-derived capsids and to refine capsids already
identified to target multiple tissue and cell types for use in gene
therapies to treat a broad range of diseases. Numerous promising
capsids have been identified and developed from these screens,
which are undergoing testing across multiple non-human primate
(NHP) and rodent species to evaluate their clinical
translatability.
- Voyager previously presented data on a set of AAV9-derived
TRACER capsids from its first campaign that demonstrated robust
delivery across the blood-brain barrier and widespread CNS
transduction in NHPs, compared to conventional AAV9 delivery, when
dosed intravenously. In addition, another AAV9-derived TRACER
capsid displayed strong cardiac transduction and significant dorsal
root ganglia detargeting in NHPs, which may help avoid dose-related
toxicities associated with AAV9 delivery.
- Voyager has identified a new array of TRACER AAV9 and AAV5
variants that have demonstrated improved CNS targeting in both NHPs
and rodents with certain AAV TRACER capsids showing a preferential
tropism for glial cells, which may enable more effective targeting
of relevant cell types for certain CNS diseases. AAV5 capsids have
been shown to have a low prevalence of preexisting neutralizing
antibodies in the general population and significant manufacturing
advantages over conventional AAV9. In addition, some of these
variants have demonstrated cross-species translatability across
primates and rodents.
- Voyager plans to present preclinical data on the performance of
these TRACER capsids in NHP and mouse models at a spring medical
conference.
Positive Preclinical Data from Vectorized Anti-HER2
Antibody Program Highlights Advancement of Rich Early-Stage
Pipeline
- Voyager continues to advance its preclinical programs powered
by its TRACER capsids. The Company believes these capsids may
enable new, best-in-class gene therapy programs with systemic IV
delivery with lower risk of dose-limiting toxicities. Our pipeline
includes gene replacement programs for spinal muscular atrophy,
diseases linked to GBA1 mutations (including Parkinson’s disease,
Lewy body dementia, and Gaucher disease), gene knockdown or
silencing programs for SOD1 ALS and Huntington’s disease, and
vectorized antibody programs for HER2+ brain metastases and
diseases associated with pathological tau (including Alzheimer’s
disease, frontal-temporal dementia, and progressive supranuclear
palsy). Voyager plans to present further preclinical data from
select programs at a spring medical conference.
- In November, the Company presented positive preclinical data
demonstrating that IV dosing of a novel TRACER AAV vector encoding
an anti-HER2 antibody payload prevented tumor growth in mouse
models of HER2+ brain metastases. This innovative, intravenously
delivered vectorized antibody approach is designed to activate the
innate immune system, destroy metastatic breast cancer tumors, and
inhibit tumor progression in the CNS. In preclinical studies,
widespread transduction of brain tissue was achieved, effectuating
expression of HER2-directed antibodies for extended periods,
resulting in substantially reduced tumor growth in multiple
orthotopic xenograft models.
Key Leadership Appointments Add to Deep R&D and
Operational Experience
- In February, Voyager announced the appointment of Alfred W.
Sandrock, Jr., M.D., Ph.D., to its Board of Directors and a
newly-formed Executive Committee of the Board consisting of Dr.
Sandrock, Mr. Higgins, and Glenn Pierce, M.D., Ph.D., Voyager’s
interim chief scientific officer. Dr. Sandrock is working work with
Voyager leadership to help shape future strategies leveraging the
Company’s TRACER™ platform and therapeutic programs, and to
expand its external collaborations with scientific leaders and
industry partners. Dr. Sandrock joined Voyager following a prolific
career in biopharmaceutical drug development.
- The Company also recently announced the promotion of Robin
Swartz to chief operating officer. Ms. Swartz joined Voyager in
2021 following a 25-year career with Genzyme and Sanofi Genzyme
where she held a number of leadership positions, including Senior
Vice President of U.S. and Global Business Operations, Senior Vice
President U.S. Rare Disease Patient and Product Services, and
Senior Director Finance.
Fourth Quarter and Full Year 2021 Financial
Results
- Collaboration Revenues: Voyager had
collaboration revenue of $28.1 million for the fourth quarter of
2021, compared to $6.5 million for the same period in 2020. The
increase in collaboration revenue was largely due to a change in
estimate related to our collaboration with Neurocrine Biosciences.
For the year ended December 31, 2021, collaboration revenue was
$37.4 million, compared to $171.1 million for the same period of
2020. The decrease in collaboration revenue is largely due to
$105.2 million of revenue related to the AbbVie collaborations
that was recognized upon the termination of the collaborations
during 2020.
- Net Loss: Net income was $5.7 million for the
fourth quarter of 2021, compared to a net loss of $15.9 million for
the same period of 2020. Net income was higher driven by the
recognition of revenue related to our collaboration with Neurocrine
Biosciences. Net loss was $71.2 million for the year ended December
31, 2021, compared to net income of $36.7 million for the same
period of 2020. Voyager had net income for 2020 driven primarily by
revenue related to the AbbVie collaborations which were terminated
during 2020.
- R&D Expenses: Research and development
expenses were $14.0 million for the fourth quarter of 2021,
compared to $22.0 million for the same period in 2020. For the year
ended December 31, 2021, R&D expenses were $73.8 million,
compared to $108.8 million for the same period of 2020. The
decrease in R&D expenses was related to employee-related
expenses driven by a reduction in headcount as well as lower
external costs primarily for clinical development and
manufacturing.
- G&A Expenses: General and administrative
expenses were $8.4 million for the fourth quarter of 2021, compared
to $8.3 million for the same period in 2020. For the year ended
December 31, 2021, G&A expenses were $37.2 million, compared to
$35.0 million for the same period of 2020. The increase in G&A
expenses was primarily related to employee-related severance
expenses in connection with a reduction-in-force commenced in the
third quarter of 2021 and facility costs.
- Cash Position: Cash, cash equivalents and
marketable securities as of December 31, 2021 were $132.5 million.
This cash position does not include the $54 million upfront payment
Voyager is entitled to receive from Novartis as part of the
Novartis license option agreement announced on March 8, 2022.
Financial Guidance
- Voyager expects that its cash, cash equivalents, and marketable
securities inclusive of upfront payments anticipated to be received
under the Novartis license option agreement will be sufficient to
meet Voyager’s planned operating expenses and capital expenditure
requirements into 2024.
Participation in Upcoming Investor Event
- Cowen 42nd Annual Health Care Conference, corporate panel
discussion, Mar. 9, 2022, 12:50 p.m. ET.
Conference CallThe Voyager Therapeutics
leadership team will host a conference call and webcast today at
8:30 a.m. ET to provide and discuss the fourth quarter and full
year 2021 financial and operating results and the Novartis license
option agreement. To access the call, please dial (877) 851-3834
(domestic) or (631) 291-4595 (international) and ask for the
Voyager Therapeutics earnings call. 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 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™ AAV Capsid
Discovery PlatformVoyager’s TRACER™ capsid discovery
platform is a broadly applicable, RNA-based functional screening
platform that allows for rapid in vivo evolution of AAV9- and
AAV5-derived capsids with enhanced tropisms and cell- and
tissue-specific transduction properties in multiple species,
including non-human primates (NHPs). Initial data from the first of
many libraries screened in NHPs demonstrated the proprietary capsid
variants effectively penetrated the blood-brain barrier and
achieved widespread biodistribution and transduction of multiple
regions of the brain. Separate results have demonstrated the
ability of certain capsids to transduce cardiac muscle and to
de-target the dorsal root ganglia. Voyager is proceeding with
additional capsid campaigns derived from AAV9, AAV5, and other
capsid serotypes to identify novel AAV vectors optimized for
specific therapeutic applications.
About Voyager TherapeuticsVoyager Therapeutics
(Nasdaq: VYGR) is leading the next generation of AAV gene therapy
to unlock the potential of the modality to treat devastating
diseases. Proprietary capsids born from the Company’s TRACER
discovery platform are powering a rich early-stage pipeline of new
and second-generation programs and may elevate the field to
overcome the narrow therapeutic window associated with conventional
gene therapy vectors across neurologic disorders and other
therapeutic areas.
voyagertherapeutics.com
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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 “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 Voyager’s
ability to continue to identify and develop proprietary capsids
from its TRACER capsid discovery platform with increased transgene
expression, increased blood-brain barrier penetration and increased
biodistribution compared to conventional AAV9 and AAV5 capsids;
Voyager’s ability to utilize its novel proprietary capsids in its
own product development programs; Voyager’s ability to attract
parties to license its novel proprietary capsids or to participate
with Voyager in research and development collaborations utilizing
its novel proprietary capsid; Voyager’s ability to advance its
AAV-based gene therapy programs; Voyager’s ability to perform its
obligations under its respective license option agreements with
Novartis and Pfizer; Voyager’s entitlement to receive upfront,
option exercise, milestone and royalty-based fees from Novartis and
Pfizer under the respective license option agreements; Voyager’s
ability to maintain its current partnerships and collaborations and
to enter into new partnerships or collaborations; Voyager’s ability
to continue to advance and to receive regulatory approvals for
product candidates under development in Voyager’s pipeline;
Voyager’s anticipated financial results, including the receipt by
Voyager of revenues or reimbursement payments from collaboration
partners; and Voyager’s ability to generate sufficient cash
resources to enable it to continue to identify and develop
proprietary capsids from its TRACER capsid discovery platform 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 imposition of governmental controls and guidance
addressing the COVID health crisis, and the financial and human
resources available to Voyager to manage the COVID-19 health
crisis; the continued development of various technology platforms,
including Voyager’s TRACER platform; the development by third
parties of capsid identification platforms that may be competitive
to Voyager’s TRACER capsid discovery platform; Voyager’s scientific
approach and general development progress; Voyager’s ability to
attract and retain talented contractors and employees to continue
the development of the TRACER capsid discovery platform and the
identification of proprietary capsids; Voyager’s ability to create
and protect intellectual property rights associated with the TRACER
capsid discovery platform and the capsids identified by the
platform; the response of the FDA and other regulators to Voyager’s
regulatory submissions and communications; the ability to attract
and retain talented contractors and employees, including key
scientists and business leaders; the ability to create and protect
intellectual property; Voyager’s ability to perform its obligations
under its license option agreements and its counterparties’
respective abilities to perform their obligations under such
agreements; the sufficiency of cash resources; the possibility or
the timing of the exercise of development, commercialization,
license and other options under the Pfizer and Novartis license
option agreements and other collaborations; the ability of Voyager
to negotiate and complete licensing or collaboration agreements on
terms acceptable to Voyager and third parties; 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 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. 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)(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
Statement
of Operations Items: |
|
2021 |
|
2020 |
|
|
2021 |
|
|
2020 |
Collaboration revenue |
|
$ |
28,073 |
|
$ |
6,537 |
|
|
$ |
37,415 |
|
|
|
171,128 |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
14,020 |
|
|
21,996 |
|
|
|
73,787 |
|
|
|
108,753 |
General and administrative |
|
|
8,351 |
|
|
8,270 |
|
|
|
37,246 |
|
|
|
34,991 |
Total operating
expenses |
|
|
22,371 |
|
|
30,266 |
|
|
|
111,033 |
|
|
|
143,744 |
Operating income
(loss) |
|
|
5,702 |
|
|
(23,729 |
) |
|
|
(73,618 |
) |
|
|
27,384 |
Total other
income |
|
|
6 |
|
|
7,802 |
|
|
|
2,421 |
|
|
|
9,357 |
Net income
(loss) |
|
$ |
5,708 |
|
$ |
(15,927 |
) |
|
$ |
(71,197 |
) |
|
$ |
36,741 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) per share, basic |
|
$ |
0.15 |
|
$ |
(0.43 |
) |
|
$ |
(1.89 |
) |
|
$ |
0.99 |
Net income
(loss) per share, diluted |
|
|
0.15 |
|
|
(0.43 |
) |
|
|
(1.89 |
) |
|
|
0.98 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding, basic |
|
|
37,804,372 |
|
|
37,290,259 |
|
|
|
37,668,947 |
|
|
|
37,132,447 |
Weighted-average common shares outstanding, diluted |
|
|
37,804,372 |
|
|
37,290,259 |
|
|
|
37,668,947 |
|
|
|
37,348,514 |
|
|
|
|
|
|
|
|
|
December 31, |
Selected Balance Sheet
Items |
|
2021 |
|
2020 |
Cash, cash equivalents, and
marketable securities |
|
$ |
132,539 |
|
$ |
174,782 |
Total assets |
|
$ |
193,855 |
|
$ |
261,584 |
Accounts payable and accrued
expenses |
|
$ |
11,524 |
|
$ |
14,839 |
Deferred revenue |
|
$ |
42,096 |
|
$ |
43,817 |
Total stockholders’
equity |
|
$ |
95,055 |
|
$ |
154,320 |
Contacts
Investors
Investors@voyagertherapeutics.com
Andrew Funderburk
afunderburk@kendallir.com
Media
Scott Santiamo
ssantiamo@vygr.com
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