– Positive preliminary Phase 2 chronic
hepatitis delta study data presented at EASL™ Congress 2024, FDA
IND clearance with Fast Track Designation received underscoring the
potential of combination therapy –
– Exclusive license agreement with Sanofi
bolsters clinical pipeline –
– Strategic workforce restructuring and phasing
out of influenza, COVID-19, and the Company’s T cell-based viral
vector platform programs –
– $1.43 billion in cash, cash equivalents and
investments as of June 30, 2024 –
– The Company lowers full-year 2024 operating
expense guidance –
– Conference call scheduled for August 1, 2024
at 1:30 p.m. PT / 4:30 p.m. ET –
Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate
update and reported financial results for the second quarter ended
June 30, 2024.
“The positive preliminary SOLSTICE Phase 2 study together with
the recent FDA IND clearance and Fast Track designation for
tobevibart and elebsiran for the treatment of chronic hepatitis
delta infection highlight the encouraging momentum we’re building
towards addressing the substantial unmet medical need for patients
affected by this life-threatening disease,” said Marianne De
Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. “In
addition, we are taking decisive steps to strategically restructure
our organization and prioritize our resources to focus on the
highest value near-term opportunities. These key strategic
decisions will enable us to drive sustainable growth and accelerate
patient impact as we advance in our mission of powering the immune
system to transform lives.”
Pipeline Programs
Chronic Hepatitis Delta (CHD)
- The Company presented positive preliminary Phase 2 chronic
hepatitis delta SOLSTICE study data at the European Association for
the Study of the Liver, EASL™ Congress 2024.
- Tobevibart monotherapy and combination therapy with elebsiran
achieved high virologic response and ALT normalization in people
living with the hepatitis delta virus after 12 and 24 weeks of
treatment.
- Complete 24-week treatment data on the approximately 60
participants is on track to be reported in the fourth quarter of
2024.
- On June 26, the U.S. Food and Drug Administration (FDA) cleared
the Company's investigational new drug (IND) application and
granted Fast Track designation for the combination of tobevibart
and elebsiran for the treatment of chronic hepatitis delta
infection.
Chronic Hepatitis B (CHB)
- The Phase 2 MARCH Part B study is fully enrolled with 48-week
end of treatment data expected in the fourth quarter of 2024. The
study is evaluating the safety, tolerability and antiviral activity
of the combination of tobevibart and elebsiran with and without
peginterferon alpha.
- Initial data from the Phase 2 PREVAIL platform study and its
THRIVE/STRIVE sub-protocols is expected in the first half of 2025.
These studies are evaluating combinations of tobevibart, elebsiran
and/or peginterferon alpha in two patient populations:
immune-active but treatment-naïve and inactive carriers.
Corporate Update
- As announced today, the Company signed an exclusive worldwide
license agreement with Sanofi for multiple potential best-in-class
clinical-stage T-cell engagers and exclusive use of the
protease-cleavable masking platform, acquired by Sanofi from Amunix
Pharmaceuticals. This license agreement is subject to the
expiration or termination of the applicable waiting period under
the Hart-Scott-Rodino Act Antitrust Improvements Act of 1976, as
amended (HSR).
- The Company initiated a strategic restructuring to advance the
development of its hepatitis programs and focus on the highest
near-term value opportunities. The organizational realignment and
optimization include phasing out programs in influenza, COVID-19,
and the Company’s T cell-based viral vector platform, as well as a
workforce reduction of approximately 25% or approximately 140
employees. The Company expects to end 2024 with approximately 435
employees, a decrease of approximately 200 from its peak headcount
in the second quarter of 2023. This includes the Sanofi employees
who are expected to join Vir following receipt of HSR clearance.
“This decision was not taken lightly yet is essential to ensure
that our resources are aligned with our evolving strategy and that
Vir is positioned for sustainable growth and long-term success,”
said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive
Officer. “I am grateful for every Vir employee who has helped to
progress our journey to bring life-saving therapies to patients and
their families.” As a result of this strategic restructuring and
prioritization the Company anticipates:
- Approximately $50 million of annual workforce cost savings
starting in 2025. Combined with the strategic actions taken in
December 2023, the Company lowered its cost structure by
approximately $90 million since its peak in 2023, part of which
will be redeployed to the newly anticipated key personnel from
Sanofi.
- Cost savings of $50 million through the end of 2025 due to the
phasing out of certain programs. These savings will substantially
be reinvested in the newly licensed programs from Sanofi following
closing of the transaction.
- Restructuring expenses estimated at $11 million to $13 million,
primarily related to employee severance cash payouts. The Company
expects to recognize most of these expenses in the second half of
2024.
- The Company will host a virtual R&D Day in late November
2024.
- On May 29, 2024, the Company announced the appointment of Mark
D. Eisner, M.D., M.P.H. as Executive Vice President and Chief
Medical Officer, effective June 3, 2024. Dr. Eisner brings
extensive late-stage clinical development expertise and deep
knowledge in the fields of immunology and infectious disease.
- On April 18, 2024, the Company announced that founding board
members Phillip Sharp, Ph.D. and Robert Perez would not stand for
reelection. Effective May 29, 2024, two new independent directors
were elected in their place, including Norbert Bischofberger,
Ph.D., who brings close to 40 years of biotech leadership
experience and Ramy Farid, Ph.D., whose pioneering work applying
advanced computational methods to drug discovery has enabled
high-quality, novel molecules for drug development and materials
applications.
Second Quarter 2024 Financial
Results
Cash, Cash Equivalents and Investments: As of June 30,
2024, the Company had approximately $1.43 billion in cash, cash
equivalents and investments. Cash, cash equivalents and investments
declined by approximately $78 million during the second quarter of
2024.
Revenues: Total revenues for the quarter ended June 30,
2024, were $3.1 million compared to $3.8 million for the same
period in 2023.
Cost of Revenue: Cost of revenue was nominal for the
second quarter of 2024 and 2023.
Research and Development Expenses (R&D): R&D
expenses for the second quarter of 2024 were $105.1 million, which
included $13.1 million of non-cash stock-based compensation
expense, compared to $168.1 million for the same period in 2023,
which included $17.1 million of non-cash stock-based compensation
expense. The decrease was primarily driven by lower clinical
development costs and manufacturing costs associated with VIR-2482,
lower contract manufacturing costs associated with the Company's
hepatitis programs, and lower personnel costs related to cost
savings initiatives implemented during the second half of 2023.
Selling, General and Administrative Expenses (SG&A):
SG&A expenses for the second quarter of 2024 were $30.3
million, which included $9.1 million of non-cash stock-based
compensation expense, compared to $45.5 million for the same period
in 2023, which included $13.5 million of non-cash stock-based
compensation expense. The decrease was primarily related to cost
savings initiatives implemented during the second half of 2023.
Restructuring, long-lived assets impairment and related
charges: Restructuring, long-lived assets impairment and
related charges for the second quarter of 2024 was $26.3 million
compared to $5.4 million for the same period in 2023. The increase
was primarily related to impairment charges related to closing our
St. Louis, Missouri facility previously announced on December 13,
2023.
Other Income: Other income for the second quarter of 2024
was $18.7 million compared to $17.6 million for the same period in
2023.
Benefit from Income Taxes: Benefit from income taxes for
the second quarter of 2024 was $1.5 million compared to $2.8
million for the same period in 2023.
Net Loss: Net loss attributable to Vir for the second
quarter of 2024 was $(138.4) million, or $(1.02) per share, basic
and diluted, compared to a net loss of $(194.8) million, or $(1.45)
per share, basic and diluted for the same period in 2023.
2024
Financial Guidance
The Company is lowering its operating expense guidance for the
full-year 2024, inclusive of its recently announced transaction
with Sanofi and strategic restructuring. This reduction is
primarily due to savings from workforce restructuring and phasing
out of influenza, COVID-19, and the Company’s T cell-based viral
vector platform programs, as well as other ongoing cost saving
efforts:
GAAP operating expense range:
$
580
to
$
610
The following expenses are included in the
GAAP operating expense range:
Stock-based compensation expense
$
90
to
$
80
Restructuring charges*
$
40
to
$
30
* Restructuring charges include employee severance cash payouts,
as well as non-cash expense related to the closing of two R&D
sites previously announced on December 13, 2023.
The revised guidance excludes the accounting impact of the
upfront payment and an escrowed milestone payment in connection
with the Sanofi agreement. The Company will incorporate any
associated impact to its guidance in its third quarter 2024
earnings press release.
Approximately three percent of the GAAP operating expense will
be funded by grants. These grants are recognized as revenue.
Except for the pending transaction with Sanofi, the GAAP
operating expense guidance does not include the effect of GAAP
adjustments caused by events that may occur subsequent to the
publication of this guidance, including, but not limited to,
business development activities, litigation, in-process R&D
impairments, and changes in the fair value of contingent
considerations.
Conference Call
Vir will host a conference call to discuss the second quarter
results at 1:30 p.m. PT / 4:30 p.m. ET today. A live webcast will
be available on https://investors.vir.bio/ and will be archived on
www.vir.bio for 30 days.
About Tobevibart (VIR-3434)
Tobevibart is an investigational subcutaneously administered
antibody designed to inhibit entry of hepatitis B and hepatitis
delta viruses into hepatocytes, neutralize both hepatitis B virus
and hepatitis delta virus virions and to reduce the level of
virions and subviral particles in the blood. Tobevibart, which
incorporates Xencor’s Xtend™ and other Fc technologies, has been
engineered to have an extended half-life and was identified using
Vir’s proprietary monoclonal antibody discovery platform.
About Elebsiran (VIR-2218)
Elebsiran is an investigational subcutaneously administered
hepatitis B virus-targeting small interfering ribonucleic acid
(siRNA) designed to degrade hepatitis B virus RNA transcripts and
limit the production of hepatitis B surface antigen. Vir believes
it has the potential to have direct antiviral activity against
hepatitis B virus and hepatitis delta virus. It is the first siRNA
in the clinic to include Enhanced Stabilization Chemistry Plus
(ESC+) technology to enhance stability and minimize off-target
activity, which potentially could result in an increased
therapeutic index. Elebsiran is the first asset in the Company’s
collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical
studies.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical
company focused on powering the immune system to transform lives by
discovering and developing medicines for serious infectious
diseases and cancer. Vir’s clinical-stage portfolio includes
infectious disease programs for chronic hepatitis delta and chronic
hepatitis B infections. Vir also has a preclinical portfolio of
programs across a range of other infectious diseases. Vir routinely
posts information that may be important to investors on its
website.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “should,” “could,” “may,” “might,” “will,”
“plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
intended to identify forward-looking statements. These
forward-looking statements are based on Vir’s expectations and
assumptions as of the date of this press release. Forward-looking
statements contained in this press release include, but are not
limited to, statements regarding anticipated expenditures and
annual savings in connection with the restructuring; the
anticipated timing of such cost impacts; Vir’s cash balance; Vir’s
financial guidance; Vir’s future financial and operating results
and its expectations related thereto; Vir’s ability to realize the
anticipated benefits from the exclusive worldwide license agreement
with Sanofi (the “Agreement”); difficulties or unanticipated
expenses in connection with the Agreement, and the potential
effects on Vir’s earnings; the risk that Vir’s investment in
connection with the Agreement will lose value for any number of
reasons; the ability of the parties to initiate, progress or
complete clinical trials within currently anticipated timelines or
at all, and the possibility of unfavorable results from studies,
including those involving SAR446309 (AMX-818), SAR446329 (AMX-500)
and SAR446368, and any additional programs that may become subject
to the Agreement; the potential clinical effects, potential
benefits, safety and efficacy of the investigational products that
are the subject of these programs; data from ongoing studies
evaluating such investigational products and programs; Vir’s
ability to file applications for regulatory approval or receive
regulatory approvals in a timely manner or at all for such
investigational products and programs, and the risk that any such
approvals may be subject to significant limitations on use; the
possibility that closing of the transaction might not occur, that
the Agreement may be terminated for any number of reasons, or that
development of the investigational products and programs subject to
the Agreement may be discontinued, and therefore may never be
successfully commercialized; Vir’s ability to successfully
commercialize any approved drug products resulting from the
Agreement; potential of, and expectations for, Vir’s pipeline;
Vir’s clinical and preclinical development programs; clinical
studies, including the enrollment of clinical studies, and the
expected timing of data readouts and presentations; the potential
benefits, safety, and efficacy of Vir’s investigational therapies;
Vir’s strategy and plans; and risks and uncertainties associated
with drug development and commercialization. Many factors may cause
differences between current expectations and actual results,
including whether or when the anticipated cost reductions will be
achieved; unexpected safety or efficacy data or results observed
during clinical studies or in data readouts; the occurrence of
adverse safety events; risks of unexpected costs, delays or other
unexpected hurdles; difficulties in collaborating with other
companies; successful development and/or commercialization of
alternative product candidates by Vir’s competitors; changes in
expected or existing competition; delays in or disruptions to Vir’s
business or clinical studies due to geopolitical changes or other
external factors; failure to achieve any necessary regulatory
approvals; the timing and amount of actual expenses, including,
without limitation, Vir’s anticipated combined GAAP R&D and
SG&A expenses; and unexpected litigation or other disputes.
Drug development and commercialization involve a high degree of
risk, and only a small number of research and development programs
result in commercialization of a product. Results in early-stage
clinical studies may not be indicative of full results or results
from later stage or larger scale clinical studies and do not ensure
regulatory approval. You should not place undue reliance on these
statements, or the scientific data presented. Other factors that
may cause actual results to differ from those expressed or implied
in the forward-looking statements in this press release are
discussed in Vir’s filings with the U.S. Securities and Exchange
Commission, including the section titled “Risk Factors” contained
therein. Except as required by law, Vir assumes no obligation to
update any forward-looking statements contained herein to reflect
any change in expectations, even as new information becomes
available.
VIR BIOTECHNOLOGY,
INC.
Condensed Consolidated Balance
Sheets
(in thousands, except share
and per share data)
(unaudited)
June 30, 2024
December 31,
2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
296,864
$
241,576
Short-term investments
849,833
1,270,980
Restricted cash and cash equivalents,
current
13,946
13,268
Equity investments
4,368
9,853
Prepaid expenses and other current
assets
40,729
52,549
Total current assets
1,205,740
1,588,226
Intangible assets, net
18,899
22,565
Goodwill
16,937
16,937
Property and equipment, net
66,063
96,018
Operating lease right-of-use assets
62,266
71,182
Restricted cash and cash equivalents,
noncurrent
6,366
6,448
Long-term investments
279,992
105,275
Other assets
13,292
12,409
TOTAL ASSETS
$
1,669,555
$
1,919,060
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES:
Accounts payable
$
4,389
$
6,334
Accrued and other liabilities
75,321
104,220
Deferred revenue, current
16,702
64,853
Total current liabilities
96,412
175,407
Operating lease liabilities,
noncurrent
95,018
111,673
Contingent consideration, noncurrent
30,600
25,960
Other long-term liabilities
13,855
15,784
TOTAL LIABILITIES
235,885
328,824
Commitments and contingencies (Note 8)
STOCKHOLDERS’ EQUITY:
Preferred stock, $0.0001 par value;
10,000,000 shares authorized as of June 30, 2024 and December 31,
2023; no shares issued and outstanding as of June 30, 2024 and
December 31, 2023
—
—
Common stock, $0.0001 par value;
300,000,000 shares authorized as of June 30, 2024 and December 31,
2023; 136,590,097 and 134,781,286 shares issued and outstanding as
of June 30, 2024 and December 31, 2023, respectively
14
13
Additional paid-in capital
1,878,013
1,828,862
Accumulated other comprehensive loss
(2,879
)
(815
)
Accumulated deficit
(441,478
)
(237,824
)
TOTAL STOCKHOLDERS’ EQUITY
1,433,670
1,590,236
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
1,669,555
$
1,919,060
VIR BIOTECHNOLOGY,
INC.
Condensed Consolidated
Statements of Operations
(in thousands, except share
and per share data)
(unaudited)
Three Months Ended June
30,
2024
2023
Revenues:
Collaboration revenue
$
55
$
(13,779
)
Contract revenue
886
1,057
Grant revenue
2,134
16,519
Total revenues
3,075
3,797
Operating expenses:
Cost of revenue
52
22
Research and development
105,113
168,083
Selling, general and administrative
30,265
45,512
Restructuring, long-lived assets
impairment and related charges
26,275
5,366
Total operating expenses
161,705
218,983
Loss from operations
(158,630
)
(215,186
)
Other income:
Change in fair value of equity
investments
429
(5,086
)
Interest income
18,846
23,016
Other expense, net
(535
)
(367
)
Total other income
18,740
17,563
Loss before benefit from income taxes
(139,890
)
(197,623
)
Benefit from income taxes
1,512
2,848
Net loss
(138,378
)
(194,775
)
Net loss attributable to noncontrolling
interest
—
—
Net loss attributable to Vir
$
(138,378
)
$
(194,775
)
Net loss per share attributable to Vir,
basic and diluted
$
(1.02
)
$
(1.45
)
Weighted-average shares outstanding, basic
and diluted
136,233,725
134,059,079
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240801724031/en/
Media Arran Attridge Senior Vice President, Corporate
Communications aattridge@vir.bio
Investors Richard Lepke Senior Director, Investor
Relations rlepke@vir.bio
Vir Biotechnology (NASDAQ:VIR)
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