Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate
update and reported financial results for the first quarter ended
March 31, 2022.
“In the first quarter, we recorded $1.2 billion
of sotrovimab collaboration revenue and remained focused on
demonstrating sotrovimab’s continued role in the response to the
COVID-19 pandemic. Notably, with more than $2.5 billion in cash,
cash equivalents, investments and collaboration receivables at the
end of the first quarter, we believe we have the resources to fund
the company for several years and to generate meaningful Phase 2
and Phase 3 data from our programs for COVID-19, hepatitis B,
hepatitis D, and influenza,” said George Scangos, Ph.D., chief
executive officer of Vir Biotechnology. “At our recent Hepatitis
Portfolio R&D Day, we shared encouraging initial data from our
Phase 2 MARCH trial evaluating hepatitis B functional cure, which
suggest that VIR-2218 and VIR-3434 are additive in reducing
hepatitis B surface antigen, and announced a new program leveraging
the same molecules to treat hepatitis D, the most aggressive form
of viral hepatitis for which there are limited treatment options.
This year we anticipate multiple data readouts from our Phase 2 and
3 COVID-19 trials, our Phase 2 hepatitis B functional cure
combination trials, and our Phase 1 HIV trial, as well as to
initiate Phase 2 trials for hepatitis B, hepatitis D and
influenza.”
Dr. Scangos continued: “In the first quarter we
also added an important new member to our management team: Johanna
Friedl-Naderer, our chief operating officer, who brings an
impressive track record of decades of strategic, operational and
commercial accomplishments.”
Corporate Update
COVID-19
- To date, and consistent with prior disclosures, binding
agreements have been received for the sale of approximately 1.7
million doses of sotrovimab worldwide (with approximately 700,000
of those doses delivered in 2021).
- In the first quarter of 2022, approximately 900,000 doses were
delivered, including 600,000 doses to the US government, which led
to the recognition of $1.2 billion of sotrovimab collaboration
revenue.
- The remaining approximately 100,000 doses are expected to be
delivered in the second quarter of 2022 to countries outside the
US.
- The Company and GlaxoSmithKline (GSK) continue to work actively
with governments around the world to make sotrovimab available to
appropriate patients.
- Sotrovimab currently has Emergency Use Authorization (EUA),
temporary authorization or marketing approval (under the brand name
Xevudy®️) in more than 40 countries.
- In March, the US Food and Drug Administration (FDA) determined
that, based on the totality of available evidence, including live
virus data generated by the Company, it is unlikely that the
sotrovimab 500 mg intravenous (IV) dose will be effective against
the Omicron BA.2 subvariant. In April, the FDA de-authorized
sotrovimab’s use in all US regions due to increases in the
proportion of COVID-19 cases caused by the Omicron BA.2
subvariant.
- In April, Canada, France and Japan maintained access to
sotrovimab 500 mg IV while noting that it is unlikely to maintain
efficacy against the Omicron BA.2 subvariant.
- The Company and GSK plan to initiate a Phase 2 trial to
evaluate the safety of higher doses of sotrovimab in the third
quarter of 2022. The companies will also continue in vitro testing
of sotrovimab against new variants and subvariants as they emerge,
and will share data with regulators in countries and regions where
sotrovimab is authorized to inform any future updates.
- The Company and GSK plan to submit a Biologics License
Application (BLA) for sotrovimab to the FDA in the second half of
2022.
- In January, the Company and GSK submitted an application to the
FDA requesting an amendment to the EUA for sotrovimab to include
intramuscular (IM) administration. The application is pending with
the FDA.
- The Company and GSK expect to start two Phase 3 trials in the
second quarter of 2022 to assess the use of sotrovimab in
uninfected individuals to determine whether sotrovimab can prevent
symptomatic COVID-19 infection.
- The primary endpoint for both trials, one platform trial
sponsored by Cambridge University Hospitals NHS Foundation Trust
called PROTECT-V, and one trial sponsored by the Company and GSK
called COMET-STAR, is incidence of symptomatic PCR-confirmed
COVID-19. The analysis of the primary endpoint of COMET-STAR will
be event driven and could be expected as early as the second half
of 2022.
- Sotrovimab is also being evaluated among patients hospitalized
with COVID-19 in the United Kingdom as part of the Randomised
Evaluation of COVID-19 Therapy (RECOVERY) Trial. Initial data are
expected in the second half of 2022.
- In February, the first patient was dosed in the Phase 2a
portion of the United Kingdom’s National Health Service-supported
AGILE initiative evaluating VIR-7832 in a trial of adults with
mild-to-moderate COVID-19. To date, no safety signals have been
reported in the Phase 1b and Phase 2a portions of the trial.
Additional data are expected in the second half of 2022.
Hepatitis B Virus (HBV)
- At its recent Hepatitis Portfolio R&D Day, the Company
announced encouraging data from the first cohort (Part A) of the
Phase 2 MARCH (Monoclonal Antibody siRNA Combination against
Hepatitis B) trial, which suggest that VIR-2218 and VIR-3434 are
additive in reducing hepatitis B surface antigen (HBsAg), with no
drug-related safety signals reported to date.
- In 2022, the Company expects data readouts from multiple trials
evaluating VIR-2218 and VIR-3434:
- Additional data from the Phase 1 monotherapy trial of VIR-3434
and Phase 2 monotherapy trial of VIR-2218 are expected in the
second quarter of 2022.
- Additional data from the Phase 2 trial of VIR-2218 in
combination with PEG-IFN-α are expected in the second half of
2022.
- Additional data from the first cohort (Part A) of the MARCH
trial evaluating safety, pharmacokinetics and HBsAg suppression are
expected in the second half of 2022. Note, with clinical trial
sites in Ukraine and Moldova, the Company continues to monitor the
war in Ukraine closely to determine any potential impact on trial
timing.
- Initial data from the Phase 2 trial evaluating VIR-2218 in
combination with BRII-179, an investigational T cell vaccine, for
the potential treatment of chronic HBV infection, led by Brii
Biosciences, are expected in the second half of 2022.
- The Company expects to initiate a Phase 2 platform trial of
VIR-2218 in combination with VIR-3434 in viremic patients
(THRIVE/STRIVE sub-protocols) in the second half of 2022.
Hepatitis D Virus (HDV)
- Also, at its recent Hepatitis Portfolio R&D Day, the
Company announced a new program designed to treat HDV, an infection
that occurs as a simultaneous co-infection or super-infection with
HBV. The Company expects to initiate a Phase 2 trial of VIR-2218 in
combination with VIR-3434 in the second half of 2022.
Other Pipeline
- In January, the Company announced an expansion of its
collaboration with the Bill & Melinda Gates Foundation to
include the advancement of innovative platform technologies in the
development of broadly neutralizing antibodies designed to provide
durable antiretroviral-free suppression of HIV and prevention of
malaria.
- In March, the Company completed enrollment in the
proof-of-concept Phase 1 trial of VIR-1111, an investigational
human immunodeficiency virus (HIV) T cell vaccine based on human
cytomegalovirus (HCMV), to evaluate whether this new approach can
elicit potentially protective immune responses that differ from
other HIV vaccines. To date, no safety signals have been reported.
Additional safety and immunology data are expected in the second
half of 2022.
- The Company expects to initiate a Phase 2 trial evaluating
VIR-2482, an investigational intramuscularly administered influenza
A-neutralizing monoclonal antibody, in the second half of 2022.
Additionally, the Company and GSK are evaluating the potential of
several next-generation monoclonal antibodies for influenza
treatment and prevention, functional genomics applications for
respiratory targets, and monoclonal antibodies for non-influenza
diseases.
Management
- In April, the Company appointed Johanna Friedl-Naderer as
executive vice president and chief operating officer responsible
for overseeing the Company’s business development, finance, product
development/regulatory and corporate affairs operations.
Previously, Ms. Friedl-Naderer served as the Company’s executive
vice president and chief business officer, global, from March 2022
to April 2022. Prior to joining Vir, Ms. Friedl-Naderer held
various positions at Biogen, most recently serving as President of
Europe, Canada & Partner Markets and as a member of Biogen’s
Global Leadership Team.
Publications
- During and following the first quarter, multiple manuscripts
were published related to the Company’s efforts to address
SARS-CoV-2 and other infectious diseases. The publications can be
found on the Literature Archive page of the Vir website.
First Quarter 2022 Financial
Results
- Revenues: Total revenues for the quarter ended
March 31, 2022, were $1.2 billion, compared to $2.0 million for the
same period in 2021.
- Collaboration revenue for the quarter ended March 31, 2022, was
$1.2 billion, with no comparable amount for the same period in
2021. The increase for the quarter was related to revenue from the
Company’s profit-sharing arrangement with GSK for the sale of
sotrovimab under the Company’s 2020 collaboration agreement with
GSK. Collaboration revenue reflects the delivery in the quarter of
approximately 900,000 sotrovimab doses. Until paid in the quarter
after it is recognized, collaboration revenue due from GSK is
classified as a receivable on the Company's consolidated balance
sheet. Collaboration revenue is calculated by applying the
Company’s contractual share of 72.5% to the revenue reported in the
period by GSK ($1.75 billion for the first quarter), net of cost of
goods sold and allowable expenses from both GSK and the Company
(e.g., medical affairs, selling and marketing expenses), and adding
back the Company’s expenses that appear elsewhere in the
consolidated statement of operations (e.g., cost of revenue).
Collaboration revenue for the quarter exceeded the Company’s first
half 2022 guidance of approximately $1.1 billion due to lower than
projected costs in the first quarter.
- Contract revenue for the quarter ended March 31, 2022, was $0.3
million, compared to $0.6 million for the same period in 2021.
- Grant revenue for the quarter ended March 31, 2022, was $ 2.5
million, compared to $ 1.4 million for the same period in 2021. The
increase for the quarter was primarily due to the timing of
research activities under the grant agreements with the Bill &
Melinda Gates Foundation.
- Cost of Revenue: Cost of revenue for the
quarter ended March 31, 2022, was $90.1 million, with no comparable
amount for the same period in 2021. The increase was due to
third-party royalties owed based on the sales of sotrovimab.
- Research and Development Expenses: Research
and development expenses for the quarter ended March 31, 2022, were
$90.2 million, which included $13.1 million of non-cash stock-based
compensation expense, compared to $134.9 million for the same
period in 2021, which included $8.4 million of non-cash stock-based
compensation expense. The decrease for the quarter was primarily
due to lower costs related to the change in the fair value of the
Company’s contingent consideration associated with research and
development activities, costs related to sotrovimab, VIR-2218, and
VIR-3434 clinical trials, collaboration agreements with GSK, and
reduced manufacturing activities for the Company’s COVID-19 product
candidates, partially offset by higher personnel-related expenses
resulting from higher headcount.
- Selling, General and Administrative Expenses:
Selling, general and administrative expenses for the quarter ended
March 31, 2022, were $38.3 million, which included $12.2 million of
non-cash stock-based compensation expense, compared to $25.7
million for the same period in 2021, which included $7.0 million of
non-cash stock-based compensation expense. The increase for the
quarter was primarily due to personnel-related expenses related to
additional headcount, external consulting services, tax expenses
related to increased revenue from the sale of sotrovimab and
allocated facilities costs due to higher lease expense.
- Other Expense: Other expense for the quarter
ended March 31, 2022, was $91.9 million, compared to $10.1 million
for the same period in 2021. The increase for the quarter was
primarily due to the unrealized loss of $95.0 million resulting
from the change in fair value of the Company's equity investment in
Brii Biosciences. No comparable amount was incurred in the same
period of 2021.
- Provision for Income Taxes: Provision for
income taxes for the quarter ended March 31, 2022, was $403.3
million, compared to $0.2 million for the same period in 2021. The
increase for the quarter was primarily due to the Company's
estimated taxable income attributable to collaboration revenue
recognized under the 2020 GSK agreement and the requirement under
the Tax Cuts and Jobs Act of 2017 for taxpayers to capitalize and
amortize research and development expenditures over five or fifteen
years pursuant to Section 174 of the Internal Revenue Code of 1986,
as amended.
- Net Income (Loss): Net income for the quarter
ended March 31, 2022, was $518.6 million, or $3.93 per share, basic
and $3.85 per share, diluted, compared to a net loss of $ 168.9
million, or $1.32 per share, basic and diluted, for the same period
in 2021. The increases for the quarter were primarily due to
collaboration revenue recognized under the 2020 GSK agreement.
- Cash, Cash Equivalents and Investments: As of
March 31, 2022, excluding restricted cash, the Company had
approximately $1.4 billion in cash, cash equivalents, and
investments. Excluding restricted cash and its equity investment in
Brii Biosciences, the Company had approximately $1.3 billion in
cash, cash equivalents and investments.
Sotrovimab in the United
States
The following is a summary of information for
sotrovimab. Healthcare providers in the US should review the Fact
Sheets for information about the authorized use of sotrovimab and
mandatory requirements of the Emergency Use Authorization (EUA).
Please see the US Food and Drug Administration (FDA) Letter of
Authorization, full Fact Sheet for Healthcare Providers and full
Fact Sheet for Patients, Parents, and Caregivers.
Sotrovimab has been authorized by the FDA for
the emergency use described below. Sotrovimab is not FDA-approved
for this use.
Sotrovimab is authorized only for the duration
of the declaration that circumstances exist justifying the
authorization of the emergency use of sotrovimab under section
564(b)(1) of the Food, Drug, and Cosmetic Act, 21 U.S.C. §
360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner. Due to the high frequency of the Omicron BA.2 subvariant,
sotrovimab is not currently authorized in any US region.
Authorized use The FDA has
issued an EUA to permit the emergency use of the unapproved product
sotrovimab for the treatment of mild-to-moderate coronavirus
disease 2019 (COVID-19) in adults and pediatric patients (12 years
of age and older weighing at least 40kg) with positive results of
direct SARS-CoV-2 viral testing, and who are at high risk for
progression to severe COVID-19, including hospitalization or
death.
Limitations of authorized
use
- Sotrovimab is not authorized for treatment of mild to moderate
COVID-19 in geographic regions where infection is likely to have
been caused by a non-susceptible SARS-CoV-2 variant based on
available information including variant susceptibility to these
drugs and regional variant frequency.
- FDA’s determination and any updates will be available at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.
Sotrovimab is not authorized for use in adult or
pediatric patients who:
- are hospitalized due to COVID-19, OR
- require oxygen therapy and/or respiratory support due to
COVID-19, OR
- require an increase in baseline oxygen flow rate and/or
respiratory support due to COVID-19 in those on chronic
oxygen.
Benefit of treatment with sotrovimab has not
been observed in patients hospitalized due to COVID-19. SARS-CoV-2
monoclonal antibodies may be associated with worse clinical
outcomes when administered to hospitalized patients with COVID-19
requiring high flow oxygen or mechanical ventilation.
Important Safety
Information
CONTRAINDICATIONS Sotrovimab is
contraindicated in patients who have a history of anaphylaxis to
sotrovimab or to any of the excipients in the formulation.
WARNINGS AND PRECAUTIONS There
are limited clinical data available for sotrovimab. Serious and
unexpected adverse events may occur that have not been previously
reported with sotrovimab use.
Hypersensitivity Including Anaphylaxis
and Infusion-Related Reactions Serious hypersensitivity
reactions, including anaphylaxis, have been observed with
administration of sotrovimab. If signs and symptoms of a clinically
significant hypersensitivity reaction or anaphylaxis occur,
immediately discontinue administration and initiate appropriate
medications and/or supportive care.
Infusion-related reactions, occurring during the
infusion and up to 24 hours after the infusion, have been observed
with administration of sotrovimab. These reactions may be severe or
life-threatening.
Signs and symptoms of infusion-related reactions
may include: fever, difficulty breathing, reduced oxygen
saturation, chills, fatigue, arrhythmia (e.g., atrial fibrillation,
sinus tachycardia, bradycardia), chest pain or discomfort,
weakness, altered mental status, nausea, headache, bronchospasm,
hypotension, hypertension, angioedema, throat irritation, rash
including urticaria, pruritus, myalgia, vaso-vagal reactions (e.g.,
pre-syncope, syncope), dizziness and diaphoresis.
If an infusion-related reaction occurs, consider
slowing or stopping the infusion and administer appropriate
medications and/or supportive care. Clinically monitor patients for
at least 1 hour after completion of the infusion for signs and
symptoms of hypersensitivity. Hypersensitivity reactions occurring
more than 24 hours after the infusion have also been reported with
the use of SARS-CoV-2 monoclonal antibodies under Emergency Use
Authorization.
Clinical Worsening After SARS-CoV-2
Monoclonal Antibody Administration Clinical worsening of
COVID‑19 after administration of SARS-CoV-2 monoclonal antibody
treatment has been reported and may include signs or symptoms of
fever, hypoxia or increased respiratory difficulty, arrhythmia
(e.g., atrial fibrillation, tachycardia, bradycardia), fatigue and
altered mental status. Some of these events required
hospitalization. It is not known if these events were related to
SARS-CoV-2 monoclonal antibody use or were due to progression of
COVID‑19.
Limitations of Benefit and Potential for
Risk in Patients with Severe COVID‑19 Benefit of treatment
with sotrovimab has not been observed in patients hospitalized due
to COVID‑19. SARS-CoV-2 monoclonal antibodies may be associated
with worse clinical outcomes when administered to hospitalized
patients with COVID‑19 requiring high flow oxygen or mechanical
ventilation. Therefore, sotrovimab is not authorized for use in
patients: who are hospitalized due to COVID‑19, OR who require
oxygen therapy due to COVID‑19 OR who require an increase in
baseline oxygen flow rate due to COVID‑19 in those on chronic
oxygen therapy due to underlying non‑COVID‑19 related
comorbidity.
ADVERSE EVENTS Infusion-related
reactions, including immediate hypersensitivity reactions, were
observed in subjects treated with sotrovimab in COMET-ICE (1%) and
in COMET-TAIL (<1%). Events reported within 24 hours of study
treatment were pyrexia, chills, dizziness, dyspnea, pruritus, rash,
and infusion-related reactions; all events were Grade 1 (mild) or
Grade 2 (moderate).
Hypersensitivity adverse reactions were observed
in 2% of patients treated with sotrovimab in COMET-ICE and in
<1% of subjects treated with sotrovimab in COMET-TAIL. All were
Grade 1 (mild) or Grade 2 (moderate). One reaction led to temporary
pausing of the infusion.
The most common treatment-emergent adverse
events observed in the sotrovimab treatment group in COMET-ICE were
rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or
Grade 2 (moderate).
USE IN SPECIFIC POPULATIONS
Pregnancy A pregnancy exposure
registry monitors pregnancy outcomes in women exposed to sotrovimab
during pregnancy. To enroll, go to
https://covid-pr.pregistry.com/ or call 1-800-616-3791 to
obtain information about the registry.
There are insufficient data to evaluate a
drug-associated risk of major birth defects, miscarriage or adverse
maternal or fetal outcome. Sotrovimab should be used during
pregnancy only if the potential benefit justifies the potential
risk for the mother and the fetus. There are maternal and fetal
risks associated with untreated COVID-19 in pregnancy.
Lactation There are no
available data on the presence of sotrovimab in human milk, the
effects on the breastfed infant or the effects on milk production.
Individuals with COVID-19 who are breastfeeding should follow
practices according to clinical guidelines to avoid exposing the
infant to COVID-19.
About VIR-7832 VIR-7832 is an
investigational dual-action SARS-CoV-2 monoclonal antibody.
Preclinical data suggest it has the potential to both block viral
entry into healthy cells and an enhanced ability to clear infected
cells. The antibody binds to an epitope on SARS-CoV-2 that is
shared with SARS-CoV-1 (the virus that causes SARS), indicating
that the epitope is highly conserved, which may make it more
difficult for resistance to develop. VIR-7832, which incorporates
Xencor’s Xtend™ and other Fc technologies, has been designed to
have an extended half-life. Importantly, VIR-7832 also has been
engineered to potentially enhance virus-specific T cell function,
which could help treat and/or prevent COVID-19 infection.
About VIR-2218 VIR-2218 is an
investigational subcutaneously administered HBV-targeting siRNA
that has the potential to stimulate an effective immune response
and have direct antiviral activity against HBV. 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 can 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-3434 VIR-3434 is an
investigational subcutaneously administered HBV-neutralizing
monoclonal antibody designed to block entry of all 10 genotypes of
HBV into hepatocytes and also 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 HBV in infected
patients, as well as to have an extended half-life.
About VIR-1111 VIR-1111 is an
investigational subcutaneously administered HIV T cell vaccine
based on HCMV that has been designed to elicit abundant T cells
that recognize HIV epitopes in a way that differs from prior HIV
vaccines.
About VIR-2482 VIR-2482 is an
investigational 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 Spanish flu pandemic. VIR-2482 is designed as a universal
prophylactic for influenza A. It has the potential to overcome the
limitations of current flu vaccines and lead to meaningfully higher
levels of protection due to its broad strain coverage and because
it does not rely on an individual to create their own protective
antibody response. 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’s Commitment to COVID-19
Vir was founded with the mission of addressing the world’s most
serious infectious diseases. In 2020, Vir responded rapidly to the
COVID-19 pandemic by leveraging our unique scientific insights and
industry-leading antibody platform to explore multiple monoclonal
antibodies as potential therapeutic or preventive options for
COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir
advanced into the clinic. It was carefully selected for its
demonstrated promise in pre-clinical research, including an
anticipated high barrier to resistance and potential ability to
both block the virus from entering healthy cells and clear infected
cells. Vir is continuing to pursue novel therapeutic and
prophylactic solutions to combat SARS-CoV-2 and future coronavirus
pandemics, both independently and in collaboration with its
partners.
About Vir Biotechnology Vir
Biotechnology is a commercial-stage immunology company focused on
combining immunologic insights with cutting-edge technologies to
treat and prevent serious infectious diseases. Vir has assembled
four technology platforms that are designed to stimulate and
enhance the immune system by exploiting critical observations of
natural immune processes. Its current development pipeline consists
of product candidates targeting COVID-19, hepatitis B virus,
influenza A and human immunodeficiency virus. We routinely post
information that may be important to investors on our website at
www.vir.bio.
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,”
“promising,” “could,” “expect,” “goal,” “anticipate,” 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 near-term financial performance
(including near-term collaboration revenue related to binding
agreements for doses of sotrovimab), Vir’s capital allocation and
investment strategy; the timing of availability of clinical data,
program updates and data disclosures related to Vir’s clinical
trials, the potential of, and expectations for, Vir’s pipeline
programs, the ability of sotrovimab and VIR-7832 to treat and/or
prevent COVID-19, statements related to regulatory authorizations
and approvals, the timing, and expected number of therapeutic doses
that Vir will be able to supply to patients, preclinical data
demonstrating the ability of sotrovimab to maintain activity
against new and circulating variants and subvariants of concern and
interest, including Omicron subvariant BA.2, planned discussions
with regulatory agencies around the world as well as planned
submissions and filings and the timing thereof, the potential of
Vir’s ongoing trials of VIR-2218 and VIR-3434 (as monotherapies or
combination therapies) in treating patients with chronic hepatitis
B virus infection, Brii Biosciences Phase 2 trial evaluating
VIR-2218 in a combination trial with BRII-179, the ability of
VIR-1111 to elicit a T cell immune response to HIV, Vir’s plans for
its HDV program, and updated plans for advancing influenza
therapies, including VIR-2482 and other therapies covered under the
GSK arrangement. Many factors may cause differences between current
expectations and actual results, including unexpected safety or
efficacy data observed during preclinical or clinical studies,
challenges in the treatment of hospitalized patients, difficulties
in collaborating with other companies or government agencies,
actual timing and content of submissions to and decisions made by
the regulatory authorities regarding sotrovimab; regulatory
submissions may take longer or be more difficult to complete than
expected; regulatory authorities may require additional information
or further studies, or may fail or refuse to approve or may delay
approval of sotrovimab; challenges in accessing manufacturing
capacity, 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 due to the COVID-19 pandemic,
geopolitical changes (such as the ongoing war between Ukraine and
Russia) or other external factors, and unexpected litigation or
other disputes. 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.
This press release contains references to
third-party information. Such information is not deemed to be
incorporated by reference in this press release. Vir disclaims
responsibility for such third-party information.
Vir Biotechnology, Inc.
Condensed Consolidated Statements of Operations
(unaudited; in thousands, except share and per share
data)
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
Collaboration revenue |
|
$ |
1,229,656 |
|
|
$ |
— |
|
Contract revenue |
|
|
282 |
|
|
|
605 |
|
Grant revenue |
|
|
2,521 |
|
|
|
1,371 |
|
Total revenue |
|
|
1,232,459 |
|
|
|
1,976 |
|
Operating
expenses: |
|
|
|
|
|
|
Cost of revenue |
|
|
90,149 |
|
|
|
— |
|
Research and development |
|
|
90,227 |
|
|
|
134,870 |
|
Selling, general and administrative |
|
|
38,255 |
|
|
|
25,739 |
|
Total operating expenses |
|
|
218,631 |
|
|
|
160,609 |
|
Income
(loss) from operations |
|
|
1,013,828 |
|
|
|
(158,633 |
) |
Other income
(expense): |
|
|
|
|
|
|
Change in fair value of equity investments |
|
|
(95,039 |
) |
|
|
— |
|
Interest income |
|
|
388 |
|
|
|
164 |
|
Other income (expense), net |
|
|
2,730 |
|
|
|
(10,246 |
) |
Total other expense |
|
|
(91,921 |
) |
|
|
(10,082 |
) |
Income
(loss) before provision for income taxes |
|
|
921,907 |
|
|
|
(168,715 |
) |
Provision
for income taxes |
|
|
(403,286 |
) |
|
|
(196 |
) |
Net income (loss) |
|
$ |
518,621 |
|
|
$ |
(168,911 |
) |
Net income
(loss) per share, basic |
|
$ |
3.93 |
|
|
$ |
(1.32 |
) |
Net income
(loss) per share, diluted |
|
$ |
3.85 |
|
|
$ |
(1.32 |
) |
Weighted-average shares outstanding, basic |
|
|
132,079,391 |
|
|
|
127,742,614 |
|
Weighted-average shares outstanding, diluted |
|
|
134,535,766 |
|
|
|
127,742,614 |
|
Vir Biotechnology, Inc.
Condensed Consolidated Balance Sheets
(unaudited; in thousands, except share and per share
data)
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
ASSETS |
|
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
812,355 |
|
|
$ |
347,815 |
|
Short-term investments |
|
|
399,829 |
|
|
|
217,182 |
|
Restricted cash and cash equivalents, current |
|
|
14,402 |
|
|
|
8,594 |
|
Receivable from collaboration |
|
|
1,223,161 |
|
|
|
773,079 |
|
Equity investments |
|
|
47,890 |
|
|
|
143,148 |
|
Prepaid expenses and other current assets |
|
|
69,911 |
|
|
|
73,003 |
|
Total current assets |
|
|
2,567,548 |
|
|
|
1,562,821 |
|
Intangible
assets, net |
|
|
33,154 |
|
|
|
33,287 |
|
Goodwill |
|
|
16,937 |
|
|
|
16,937 |
|
Property and
equipment, net |
|
|
65,583 |
|
|
|
42,834 |
|
Operating
right-of-use assets |
|
|
88,331 |
|
|
|
87,220 |
|
Restricted
cash and cash equivalents, noncurrent |
|
|
9,040 |
|
|
|
7,006 |
|
Long-term
investments |
|
|
103,535 |
|
|
|
201,388 |
|
Other
assets |
|
|
3,001 |
|
|
|
2,775 |
|
TOTAL
ASSETS |
|
$ |
2,887,129 |
|
|
$ |
1,954,268 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
CURRENT
LIABILITIES: |
|
|
|
|
|
|
Accounts payable |
|
$ |
10,955 |
|
|
$ |
6,521 |
|
Accrued and other liabilities |
|
|
577,669 |
|
|
|
236,512 |
|
Deferred revenue, current portion |
|
|
113,737 |
|
|
|
98,209 |
|
Contingent consideration, current portion |
|
|
— |
|
|
|
— |
|
Total current liabilities |
|
|
702,361 |
|
|
|
341,242 |
|
Deferred
revenue, noncurrent |
|
|
5,865 |
|
|
|
3,815 |
|
Operating
lease liabilities, noncurrent |
|
|
132,813 |
|
|
|
133,561 |
|
Contingent
consideration, noncurrent |
|
|
18,891 |
|
|
|
22,822 |
|
Deferred tax
liability |
|
|
18,439 |
|
|
|
18,439 |
|
Other
long-term liabilities |
|
|
7,746 |
|
|
|
2,540 |
|
TOTAL
LIABILITIES |
|
|
886,115 |
|
|
|
522,419 |
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
Preferred
stock, $0.0001 par value; 10,000,000 shares authorized as of March
31, 2022 and December 31, 2021; no shares issued and outstanding as
of March 31, 2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value; 300,000,000 shares authorized as of March
31, 2022 and December 31, 2021; 132,353,441 and 131,161,404 shares
issued and outstanding as of March 31, 2022 and December 31, 2021,
respectively |
|
|
13 |
|
|
|
13 |
|
Additional
paid-in capital |
|
|
1,625,785 |
|
|
|
1,571,535 |
|
Accumulated
other comprehensive loss |
|
|
(4,805 |
) |
|
|
(1,099 |
) |
Retained
earnings (accumulated deficit) |
|
|
380,021 |
|
|
|
(138,600 |
) |
TOTAL
STOCKHOLDERS’ EQUITY |
|
|
2,001,014 |
|
|
|
1,431,849 |
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
2,887,129 |
|
|
$ |
1,954,268 |
|
Contacts:
Heather Rowe Armstrong
VP, Investor Relations
harmstrong@vir.bio
+1-415-915-4228
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1-415-941-6746
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