Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate
update and reported financial results for the second quarter ended
June 30, 2023.
“Our strategy is to prioritize our monoclonal
antibody platform, which has already yielded two impactful
medicines for patients and, along with our artificial
intelligence-enabled capabilities, plan to apply it more broadly in
infectious diseases and beyond,” said Marianne De Backer, M.Sc.,
Ph.D., MBA, Vir’s Chief Executive Officer. “As we execute on this
strategy, we look forward to our near-term catalysts, which include
data readouts from our Phase 2 chronic hepatitis B and hepatitis
delta programs in the fourth quarter. Our future prospects are rich
with opportunity based on our deep pipeline and strong balance
sheet.”
Pipeline Programs
Chronic Hepatitis B (CHB)
- Multiple trials evaluating the
potential for VIR-2218 and VIR-3434 to achieve a functional cure
for CHB are on track with data expected in Q4 2023.
- In June, the Company presented new
data from its CHB portfolio at the EASL™ (European Association for
the Study of the Liver) Congress.
- In May, the Company announced the
initiation of the Phase 2 PREVAIL platform trial and its
THRIVE/STRIVE sub-protocols. The platform is evaluating
combinations of VIR-2218, VIR-3434 and/or PEG-IFN-α in two CHB
patient populations with the potential to evaluate other
populations in the future. Initial data from this platform trial
are expected in the first half of 2024.
Chronic Hepatitis Delta
(CHD)
- The Phase 2 SOLSTICE trial
evaluating VIR-2218 and VIR-3434 as monotherapy and in combination
for the treatment of people living with CHD, the most aggressive
form of viral hepatitis, remains on track with initial data
expected in Q4 2023.
- In June, the Company presented
preclinical in vivo and in vitro data demonstrating the antiviral
properties of VIR-2218 and VIR-3434 against hepatitis delta virus
at the EASL Congress. These data further support the clinical
development of these investigational medicines as a treatment for
the chronic suppression of hepatitis delta virus.
Influenza
- In July, Vir reported that the
Phase 2
Prevention of
Illness
Due to Influenza
A (PENINSULA) trial evaluating VIR-2482 for the
prevention of symptomatic influenza A illness did not meet primary
or secondary efficacy endpoints.
- The Company continues to analyze
the data and plans to share additional findings once
available.
Human Immunodeficiency Virus
(HIV)
- Vir expects the Phase 1 trial for
VIR-1388, a novel T cell vaccine for the prevention of HIV, to
begin dosing in Q3 2023. Vir’s T cell platform utilizes human
cytomegalovirus (HCMV) as a vector, which has the potential to
induce high frequencies of antigen-specific, tissue-localizing
effector memory T cells. The trial will be supported by the
National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health, and the Bill & Melinda
Gates Foundation, and will be conducted by the HIV Vaccine Trials
Network. NIAID has provided funding throughout the product
development lifecycle of VIR-1388.
COVID-19
- Sotrovimab currently has emergency
authorization, temporary authorization or marketing approval (under
the brand name Xevudy®️) for early treatment of COVID-19. It has
been supplied to more than 40 countries and remains in use outside
of the US.
Preclinical Pipeline
Candidates
- Vir is continuing to advance
next-generation monoclonal antibodies (mAbs) based on its
proprietary platform and enabled by AI and machine-learning
capabilities to deliver high-quality solutions more efficiently.
These include:
- VIR-2981, an investigational
neuraminidase-targeting mAb against both influenza A and B
viruses.
- VIR-8190, a mAb against respiratory
syncytial virus (RSV) and human metapneumovirus (hMPV).
- VIR-7229, a next-generation
COVID-19 mAb that has been shown in laboratory studies to have high
potency against a broad spectrum of historical and currently
circulating variants.
- Additionally, the Company is
advancing VIR-1949, a therapeutic T cell vaccine for control of
precancerous lesions caused by human papillomavirus (HPV) based on
Vir’s HCMV vector platform.
Corporate Update
- In July, Vir made the decision to
increase focus on its proprietary antibody platform and discontinue
its innate immunity small molecule platform.
- In June, Sasha Damouni Ellis joined
Vir as Executive Vice President and Chief Corporate Affairs
Officer. Previously, she was Senior Vice President, Corporate
Affairs and Investor Relations of Marinus Pharmaceuticals.
- In May, Jeff Calcagno, M.D., joined
Vir as Executive Vice President and Chief Business Officer. He
joined Vir from Johnson & Johnson (J&J), where he spent
more than 12 years holding leadership roles of increasing
responsibility within all three divisions of J&J Innovation
(JJI), including as Global Transactions Lead for Infectious
Diseases & Vaccines and as Head of JLABS Bay Area.
Second Quarter 2023 Financial Results
Cash, Cash Equivalents and
Investments: As of June 30, 2023, the Company had
approximately $1.9 billion in cash, cash equivalents and
investments. In the second quarter of 2023, a payment of $273.6
million was made to GSK primarily for excess sotrovimab supply and
manufacturing capacity that was reserved in 2022; a balance of
$69.7 million remains, of which the Company anticipates making a
payment of approximately $41.8 million to GSK in the third quarter
of 2023.
Revenues: Total revenues for the quarter ended
June 30, 2023, were $3.8 million compared to $(40.6) million for
the same period in 2022.
Revenues were comprised of the following
components:
(in millions) |
Three months ended June 30 |
|
|
|
|
2023 |
|
2022 |
% Change |
Collaboration revenue |
|
$(13.8 |
) |
|
$(54.9 |
) |
(74.9 |
%) |
Contract revenue |
|
1.1 |
|
|
12.3 |
|
(91.1 |
%) |
Grant revenue |
|
16.5 |
|
|
2.1 |
|
>100 |
% |
Total
revenues |
|
$3.8 |
|
|
$(40.6 |
) |
>100 |
% |
Note: Numbers may
not add due to rounding. |
|
- Collaboration
revenue: The year-over-year change in collaboration
revenue was primarily driven by a $397.4 million charge for a
profit-share constraint recorded in the second quarter of 2022
which more than offset the $342.5 million profit-sharing amount
recorded in the same quarter. The constraint represents an estimate
for excess sotrovimab supply and manufacturing capacity and reduces
the profit-sharing amount. In the second quarter of 2023,
collaboration revenue was $(13.8) million primarily due to
sotrovimab sales that were more than offset by manufacturing costs
and expenses to support activities where sotrovimab has marketing
authorization. These activities are led by the Company’s
collaboration partner GSK.
- Contract revenue:
The decrease in contract revenue was primarily driven by a $7.0
million upfront payment related to a license granted to GSK in the
second quarter of 2022.
- Grant
revenue: The increase in grant revenue was primarily
driven by $11.8 million related to the Company’s grant with
Biomedical Advanced Research and Development Authority (BARDA)
supporting the Company’s Phase 2 PENINSULA
trial evaluating VIR-2482 for the prevention of symptomatic
influenza A illness in the second quarter of 2023.
Cost of Revenue: Cost of
revenue for the second quarter of 2023 was not material
compared to $27.9 million for the same period in 2022. The decrease
was due to lower third-party royalties owed based on the sales of
sotrovimab.
Research and Development Expenses
(R&D): R&D expenses for the second quarter of 2023
were $171.9 million, which included $17.1 million of non-cash
stock-based compensation expense, compared to $115.1 million for
the same period in 2022, which included $14.1 million of non-cash
stock-based compensation expense. The increase was primarily driven
by higher investments to support the advancement of our clinical
programs and, in particular, VIR-2482.
Selling, General and Administrative
Expenses (SG&A): SG&A expenses for the second
quarter of 2023 were $47.1 million, which included $13.5 million of
non-cash stock-based compensation expense, compared to $41.6
million for the same period in 2022, which included $13.0 million
of non-cash stock-based compensation expense. The increase was
primarily due to higher personnel-related costs to support the
growth of the Company.
Other Income (Expense): Other
income for the second quarter of 2023 was $17.6 million compared to
other expense of $(8.5) million for the same period in 2022. The
increase was primarily due to higher interest income related to
higher interest rates along with an overall higher investment
balance.
Benefit from Income Taxes:
Benefit from income taxes for the second quarter of 2023 was $2.8
million compared to $157.2 million benefit from income taxes for
the same period in 2022. The decrease was primarily due to the
Company’s inability to realize tax benefit associated with the net
loss for the three months ended June 30, 2023.
Net Loss: Net loss attributable
to Vir for the second quarter of 2023 was $194.8 million, or $1.45
per share, basic and diluted, compared to a net loss of $76.5
million, or $0.58 per share, basic and diluted, for the same period
in 2022.
Conference CallVir will host a
conference call to discuss the Q2 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 VIR-2218 VIR-2218 is an
investigational subcutaneously administered hepatitis B
virus-targeting small interfering ribonucleic acid (siRNA) that Vir
believes has the potential to stimulate an effective immune
response and 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.
VIR-2218 is the first asset in the Company’s collaboration with
Alnylam Pharmaceuticals, Inc. to enter clinical trials.
About VIR-3434VIR-3434 is an
investigational subcutaneously administered antibody designed to
block entry of hepatitis B and hepatitis delta viruses into
hepatocytes and to reduce the level of virions and subviral
particles in the blood. VIR-3434, which incorporates Xencor’s
Xtend™ and other Fc technologies, has been engineered to
potentially function as a T cell vaccine against hepatitis B virus
and hepatitis delta virus, as well as to have an extended
half-life. VIR-3434 was identified using Vir’s proprietary mAb
discovery platform.
About VIR-2482VIR-2482 is an
investigational hemagglutinin targeting, intramuscularly
administered influenza A-neutralizing monoclonal antibody. In
vitro, it has been shown to cover all major strains of influenza A
that have arisen since the 1918 flu pandemic. VIR-2482 is designed
as a prophylactic for influenza A. VIR-2482, which incorporates
Xencor’s Xtend™ technology, also has been half-life engineered so
that a single dose has the potential to last the entire flu season.
VIR-2482 was identified using Vir’s proprietary mAb discovery
platform. Under the collaboration agreement signed with GSK in
2021, GSK has an exclusive option to lead post-Phase 2 development
and commercialization of VIR-2482.
The PENINSULA trial has been supported in whole
or in part with federal funds from the Department of Health and
Human Services (HHS); Administration for Strategic Preparedness and
Response (ASPR); Biomedical Advanced Research and Development
Authority (BARDA), under Other Transaction Number:
75A50122C00081.
About VIR-2981VIR-2981 is an
investigational neuraminidase-targeting monoclonal antibody against
influenza viruses. It targets a region of the neuraminidase protein
that is highly conserved across influenza A and B strains and is
designed to inhibit the influenza neuraminidase, a key viral
protein that facilitates release of new viruses in infected
individuals. Preclinical data demonstrate the antibody’s breadth
and potency against all major strains of seasonal and pandemic
influenza viruses and support the potential of this antibody in the
prevention of influenza illness. Vir-2981 was identified using
Vir’s proprietary mAb discovery platform.
About VIR-1388VIR-1388 is an
investigational subcutaneously administered HIV T cell vaccine
based on HCMV that has been designed to elicit abundant T cells
that recognize HIV proteins in a way that differs from prior
investigational HIV vaccines. VIR-1388 uses applied learnings from
VIR-1111, Vir’s initial investigational proof-of-concept HIV T cell
vaccine, with the goal of creating a safe and effective HIV
vaccine. VIR-1388 was identified using Vir’s proprietary mAb
discovery platform.
About SotrovimabSotrovimab is
an investigational SARS-CoV-2 neutralizing monoclonal antibody that
was developed in collaboration with GSK. The antibody binds to an
epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes
SARS). Sotrovimab, which incorporates Xencor, Inc.’s Xtend™️
technology, has been designed to achieve high concentration in the
lungs to achieve optimal penetration into airway tissues affected
by SARS-CoV-2 and to have an extended half-life. Sotrovimab was
identified using Vir’s proprietary mAb discovery platform.
Sotrovimab is currently not authorized in the US.
About VIR-7229VIR-7229 is a
preclinical monoclonal antibody that neutralizes all historical and
currently circulating COVID-19 variants with high potency in vitro.
Vir-7229 incorporates Xencor, Inc.’s Xtend™️ technology. VIR-7229
was identified using Vir’s proprietary mAb discovery platform.
About VIR-8190VIR-8190 is a
dual specificity monoclonal antibody that has the ability to
potently neutralize both respiratory syncytial virus (RSV) and
human metapneumovirus (hMPV) strains. RSV and HMPV are recognized
as significant causes of lower respiratory tract disease in
high-risk populations, including infants and immunocompromised
individuals. VIR-8190 was identified using Vir’s proprietary mAb
discovery platform.
About VIR-1949VIR-1949 is a
preclinical therapeutic vaccine designed to treat HPV-related
high-grade squamous epithelial pre-cancer lesions (HSIL) and
cancers. This vaccine uses HCMV as the vaccine vector. Based on
preclinical data, HCMV vectors have the potential to induce high
frequencies of antigen-specific, tissue-localizing effector memory
T cells.
About Vir BiotechnologyVir
Biotechnology, Inc. is an immunology company focused on
combining cutting-edge technologies to treat and prevent infectious
diseases and other serious conditions. Vir has assembled two
technology platforms that are designed to stimulate and enhance the
immune system by exploiting critical observations of natural immune
processes. Its current clinical development pipeline consists of
product candidates targeting hepatitis B and hepatitis delta
viruses, influenza A and B, human immunodeficiency virus and
COVID-19. Vir has several preclinical candidates in its pipeline.
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 “may,” “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 Vir’s strategy and
plans; Vir’s cash balance; Vir’s future financial and operating
results and its expectations related thereto; potential of, and
expectations for, Vir’s pipeline; Vir’s clinical development
programs, clinical trials, including the enrollment of Vir’s
clinical trials, and the expected timing of data readouts and
presentations; the potential benefits, safety, and efficacy of
Vir’s investigational therapies; and risks and uncertainties
associated with drug development and commercialization. Many
important factors may cause differences between current
expectations and actual results, including unexpected safety or
efficacy data or results observed during clinical trials or in data
readouts; the timing and outcome of Vir’s planned interactions with
regulatory authorities; difficulties in obtaining regulatory
approval; uncertainty as to whether the anticipated benefits of
Vir’s collaborations with other companies can be achieved;
difficulties in collaborating with other companies; challenges in
accessing manufacturing capacity; clinical site activation rates or
clinical trial enrollment rates that are lower than expected;
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 trials, geopolitical changes or other external factors;
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
trials may not be indicative of full results or results from
later-stage or larger-scale clinical trials 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 US 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 30,2023 |
|
December 31,2022 |
ASSETS |
|
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash equivalents |
$ |
666,949 |
|
|
$ |
848,631 |
|
Short-term investments |
|
1,166,953 |
|
|
|
1,521,517 |
|
Restricted cash and cash equivalents, current |
|
13,163 |
|
|
|
12,681 |
|
Equity investments |
|
13,531 |
|
|
|
31,892 |
|
Prepaid expenses and other current assets |
|
85,736 |
|
|
|
104,356 |
|
Total current assets |
|
1,946,332 |
|
|
|
2,519,077 |
|
Intangible assets, net |
|
25,590 |
|
|
|
32,755 |
|
Goodwill |
|
16,937 |
|
|
|
16,937 |
|
Property and equipment,
net |
|
104,126 |
|
|
|
105,609 |
|
Operating right-of-use
assets |
|
74,934 |
|
|
|
82,557 |
|
Restricted cash and cash
equivalents, noncurrent |
|
6,744 |
|
|
|
6,656 |
|
Long-term investments |
|
52,358 |
|
|
|
23,927 |
|
Other assets |
|
16,853 |
|
|
|
14,570 |
|
TOTAL ASSETS |
$ |
2,243,874 |
|
|
$ |
2,802,088 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
CURRENT LIABILITIES: |
|
|
|
Accounts payable |
$ |
12,362 |
|
|
$ |
6,422 |
|
Accrued and other liabilities |
|
197,580 |
|
|
|
489,090 |
|
Deferred revenue, current portion |
|
15,681 |
|
|
|
15,517 |
|
Total current liabilities |
|
225,623 |
|
|
|
511,029 |
|
Deferred revenue,
noncurrent |
|
53,207 |
|
|
|
53,207 |
|
Operating lease liabilities,
noncurrent |
|
117,815 |
|
|
|
123,837 |
|
Contingent consideration,
noncurrent |
|
24,927 |
|
|
|
24,937 |
|
Other long-term
liabilities |
|
12,094 |
|
|
|
11,115 |
|
TOTAL LIABILITIES |
|
433,666 |
|
|
|
724,125 |
|
Commitments and contingencies
(Note 7) |
|
|
|
STOCKHOLDERS’ EQUITY: |
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as
of June 30, 2023 and December 31, 2022; no shares issued
and outstanding as of June 30, 2023 and December 31,
2022 |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 300,000,000 shares authorized as
of June 30, 2023 and December 31, 2022; 134,230,494 and
133,236,687 shares issued and outstanding as of June 30, 2023
and December 31, 2022, respectively |
|
13 |
|
|
|
13 |
|
Additional paid-in
capital |
|
1,771,536 |
|
|
|
1,709,835 |
|
Accumulated other
comprehensive loss |
|
(2,903 |
) |
|
|
(9,122 |
) |
Retained earnings |
|
41,562 |
|
|
|
377,237 |
|
TOTAL STOCKHOLDERS’
EQUITY |
|
1,810,208 |
|
|
|
2,077,963 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
2,243,874 |
|
|
$ |
2,802,088 |
|
VIR BIOTECHNOLOGY, INC. |
Condensed Consolidated Statements of Operations |
(in thousands, except share and per share data) |
(unaudited) |
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
Collaboration revenue |
$ |
(13,779 |
) |
|
$ |
(54,941 |
) |
|
$ |
32,795 |
|
|
$ |
1,174,715 |
|
Contract revenue |
|
1,057 |
|
|
|
12,254 |
|
|
|
1,195 |
|
|
|
12,536 |
|
Grant revenue |
|
16,519 |
|
|
|
2,058 |
|
|
|
32,764 |
|
|
|
4,579 |
|
Total revenues |
|
3,797 |
|
|
|
(40,629 |
) |
|
|
66,754 |
|
|
|
1,191,830 |
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of revenue |
|
22 |
|
|
|
27,921 |
|
|
|
1,929 |
|
|
|
118,070 |
|
Research and development |
|
171,860 |
|
|
|
115,082 |
|
|
|
329,503 |
|
|
|
205,309 |
|
Selling, general and administrative |
|
47,101 |
|
|
|
41,590 |
|
|
|
93,879 |
|
|
|
79,845 |
|
Total operating expenses |
|
218,983 |
|
|
|
184,593 |
|
|
|
425,311 |
|
|
|
403,224 |
|
(Loss) income from
operations |
|
(215,186 |
) |
|
|
(225,222 |
) |
|
|
(358,557 |
) |
|
|
788,606 |
|
Other income (expense): |
|
|
|
|
|
|
|
Change in fair value of equity investments |
|
(5,086 |
) |
|
|
(11,390 |
) |
|
|
(18,189 |
) |
|
|
(106,429 |
) |
Interest income |
|
23,016 |
|
|
|
2,200 |
|
|
|
44,323 |
|
|
|
2,588 |
|
Other (expense) income, net |
|
(367 |
) |
|
|
691 |
|
|
|
(8,388 |
) |
|
|
3,421 |
|
Total other income (expense) |
|
17,563 |
|
|
|
(8,499 |
) |
|
|
17,746 |
|
|
|
(100,420 |
) |
(Loss) income before benefit
from (provision for) income taxes |
|
(197,623 |
) |
|
|
(233,721 |
) |
|
|
(340,811 |
) |
|
|
688,186 |
|
Benefit from (provision for)
income taxes |
|
2,848 |
|
|
|
157,228 |
|
|
|
5,080 |
|
|
|
(246,058 |
) |
Net (loss) income |
$ |
(194,775 |
) |
|
$ |
(76,493 |
) |
|
$ |
(335,731 |
) |
|
$ |
442,128 |
|
Net loss attributable to noncontrolling interest |
$ |
— |
|
|
$ |
— |
|
|
$ |
(56 |
) |
|
$ |
— |
|
Net (loss) income attributable to Vir |
$ |
(194,775 |
) |
|
$ |
(76,493 |
) |
|
$ |
(335,675 |
) |
|
$ |
442,128 |
|
Net (loss) income per share
attributable to Vir, basic |
$ |
(1.45 |
) |
|
$ |
(0.58 |
) |
|
$ |
(2.51 |
) |
|
$ |
3.34 |
|
Net (loss) income per share
attributable to Vir, diluted |
$ |
(1.45 |
) |
|
$ |
(0.58 |
) |
|
$ |
(2.51 |
) |
|
$ |
3.28 |
|
Weighted-average shares
outstanding, basic |
|
134,059,079 |
|
|
|
132,450,018 |
|
|
|
133,807,357 |
|
|
|
132,326,244 |
|
Weighted-average shares
outstanding, diluted |
|
134,059,079 |
|
|
|
132,450,018 |
|
|
|
133,807,357 |
|
|
|
134,643,840 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts:
Media
Carly Scaduto
Senior Director, Media Relations
cscaduto@vir.bio
+1-314-368-5189
Investors
Sasha Damouni Ellis
Executive Vice President, Chief Corporate Affairs Officer
sdamouni@vir.bio
Vir Biotechnology (NASDAQ:VIR)
Historical Stock Chart
From Apr 2024 to May 2024
Vir Biotechnology (NASDAQ:VIR)
Historical Stock Chart
From May 2023 to May 2024