Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate
update and reported financial results for the first quarter ended
March 31, 2021.
“We’ve had an active start to the year,
achieving significant clinical and collaboration milestones across
our portfolio of investigational compounds for serious infectious
diseases,” said George Scangos, Ph.D., chief executive officer
of Vir Biotechnology. “Based on the profound efficacy results
from our Phase 3 trial of VIR-7831 and our belief in its ongoing
ability to address known variants of concern, we remain confident
in the potential of this dual-action monoclonal antibody to play an
important role in bringing the COVID-19 pandemic to an end. We look
forward to the pending Emergency Use Authorization decisions in the
U.S. and Europe. In the interim, we are rapidly progressing the
initiation of new studies aimed at both the prevention and
treatment of COVID-19, as well as new delivery methods that we hope
will help ease administration and access in the future.
Importantly, we are also excited to share several new data sets
from our robust hepatitis B pipeline in the second quarter, and
expect to maintain our executional momentum throughout the
year.”
Corporate Update
COVID-19 Updates
- In February, the Company initiated
COMET-PEAK (COVID-19 Monoclonal antibody Efficacy Trial - Patient
SafEty, TolerAbility, PharmacoKinetics), a Phase 2 trial with two
parts. The first part, initiated in February, is evaluating the
similarity in pharmacokinetics between VIR-7831 manufactured by
different processes. The second part, which began in April, is
comparing the safety and viral kinetics of intramuscularly (IM)
administered VIR-7831 to intravenously (IV) administered VIR-7831
among low-risk adults with mild to moderate COVID-19. The low 500
mg dose of VIR-7831 lends itself to administration via an IM route,
and could facilitate broader access to monoclonal antibody therapy
in settings where IV administration is not feasible. Data are
expected in the second half of 2021.
- In March, the Company announced
that the VIR-7831 arm of the National Institutes of Health’s
(NIH) ACTIV (Accelerating COVID-19 Therapeutic Interventions and
Vaccines) Program Phase 3 clinical trial met initial pre-specified
criteria, and no safety signals were reported. Based on sensitivity
analyses of the available data, the independent Data and Safety
Monitoring Board recommended the VIR-7831 arm be closed to
enrollment. The Company anticipates an NIH-led manuscript to be
published later this year.
- In March, the Company announced an
Independent Data Monitoring Committee (IDMC) recommended the Phase
3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early
treatment of COVID-19 in adults at high risk of hospitalization be
stopped for enrollment due to evidence of profound efficacy. The
IDMC recommendation was based on an interim analysis of data from
583 patients enrolled in the COMET-ICE trial, which demonstrated an
85% (p=0.002) reduction in hospitalization or death in patients
receiving VIR-7831 as monotherapy compared to placebo, the primary
endpoint of the trial. VIR-7831 was well tolerated. As the trial
remains ongoing and blinded with patients continuing to be followed
for 24 weeks, additional results, including epidemiology and
virology data, will be forthcoming once the trial is
completed.
- In March, the Company announced the
submission of an Emergency Use Authorization (EUA) request to
the U.S. Food and Drug Administration (FDA) for VIR-7831
for the treatment of adults and adolescents (aged 12 years and over
and weighing at least 40 kg) with mild-to-moderate COVID-19 who are
at risk for progression to hospitalization or death. The submission
is based on the interim analysis of efficacy and safety data from
the Phase 3 COMET-ICE trial. These data will also form the basis
for a Biologics License Application (BLA) submission to the FDA,
planned in the second half of 2021.
- In March, the Company announced
topline data from Eli Lilly and Company’s (Eli Lilly) expanded
Phase 2 BLAZE-4 trial evaluating the potential benefits of VIR-7831
together with Eli Lilly’s investigational bamlanivimab (LY-CoV555)
in low-risk adult patients with mild to moderate COVID-19. Results
from the trial, which began dosing in January, showed that
bamlanivimab 700 mg co-administered with VIR-7831 500 mg
demonstrated a 70% (p<0.001) relative reduction in persistently
high viral load (>5.27; cycle threshold value <27.5) at day 7
compared to placebo, meeting the primary endpoint. In addition,
bamlanivimab administered with VIR-7831 demonstrated a
statistically significant reduction compared to placebo in the key
virologic secondary endpoints of mean change from baseline to days
3, 5, and 7 in SARS-CoV-2 viral load. No serious adverse events
were reported in either trial arm. Together with Eli Lilly and
GlaxoSmithKline plc (GSK), the Company is engaging with the FDA and
anticipates working with other global regulators regarding the
possible co-administration of bamlanivimab and VIR-7831 for the
treatment of COVID-19.
- In April, the Company announced
that the European Medicines Agency (EMA) initiated a review of
VIR-7831 for the treatment of adults and adolescents with COVID-19
who do not require oxygen supplementation and who are at high risk
of progressing to severe COVID-19. The review is being carried out
by the EMA’s Committee for Human Medicinal Products (CHMP) and will
provide European Union-wide recommendations for national
authorities who may take evidence-based decisions on the early use
of the medicine, ahead of any formal Marketing Authorization
Application.
- In April, the first patient was
dosed in the UK National Health Service-supported AGILE initiative.
The trial initiative, which the Company announced in January, is
the first to evaluate VIR-7832 in a Phase 1b/2a trial of adults
with mild to moderate COVID-19. VIR-7832 shares the same
characteristics as VIR-7831 and has been engineered to potentially
be a therapeutic T cell vaccine to further help treat and/or
prevent COVID-19. Initial safety data are expected in the second
half of 2021.
- In the second quarter of 2021, the
Company plans to initiate two additional trials evaluating IM
administration of VIR-7831:
- COMET-TAIL (Treatment of Acute
COVID-19 with Intramuscular monocLonal antibody) – a Phase 3 trial
in high-risk adults to assess whether IM-administered VIR-7831 can
reduce hospitalization or death due to COVID-19
- COMET-STAR (Stop Transmission of
Acute SARS-CoV-2) – a Phase 3 trial in uninfected adults at high
risk to determine whether IM-administered VIR-7831 can prevent
symptomatic COVID-19 infection
- In connection with the advancement
of Vir’s SARS-CoV-2 monoclonal antibody programs, the Company has
established a strategic manufacturing network that will enable the
manufacture of approximately two million doses to patients in the
first year following potential EUA, and several fold that in the
second year, depending on titer and yield.
Chronic Hepatitis B Virus (HBV) Updates
- In January, the Company entered
into a clinical collaboration with Gilead Sciences, Inc. (Gilead)
to evaluate VIR-2218 in a Phase 2 combination therapy trial with
selgantolimod (GS-9688), Gilead’s investigational TLR-8 agonist,
and nivolumab, an approved PD-1 inhibitor, in both
treatment-experienced and treatment-naïve patients with HBV. The
trial, which is aimed at developing a functional cure for chronic
HBV, is expected to start in the second half of 2021.
- In late January, the Company
announced initial topline data from an ongoing Phase 1 trial
evaluating VIR-3434, an HBV-neutralizing monoclonal antibody with
the potential to be a therapeutic T cell vaccine, for the treatment
of patients with chronic HBV. The first blinded cohort consisted of
eight patients with chronic HBV who were taking nucleoside reverse
transcriptase inhibitors (NRTIs), two of whom received placebo, and
six of whom received a single dose of 6 mg VIR-3434. Six of eight
patients achieved a mean 1.3 log10 IU/mL reduction in serum
HBV surface antigen (HBsAg) by day eight, the day when nadir was
achieved in most patients. Additional safety and efficacy data
will be presented at The European Association for the Study of the
Liver’s (EASL) International Liver Conference in June. The Company
also expects to initiate a Phase 2 trial of VIR-3434 in combination
with VIR-2218 in the second half of 2021.
- In February, the Company presented
encore data on VIR-2218 at the Asian Pacific Association for the
Study of the Liver. Presentations included preliminary results from
the Company’s ongoing Phase 2 trial of VIR-2218 (oral) and data
characterizing the urine and plasma pharmacokinetics of VIR-2218
(poster). One-year response durability data for VIR-2218 as a
monotherapy for HBV will be presented at the EASL International
Liver Conference in June.
- In April, the Company announced
that its collaborator Brii Biosciences initiated a Phase 2 trial
evaluating VIR-2218 in combination with BRII-179, an
investigational T cell vaccine, for the treatment of chronic HBV
infection.
- During the quarter, the Company
continued to progress a Phase 2 combination trial of VIR-2218 with
pegylated interferon-alpha (PEG-IFN-α) to evaluate the potential
for this combination to result in a functional cure for HBV.
Initial clinical data will be presented at the EASL International
Liver Conference in June.
- The Company received notification
of acceptance of four abstracts for presentation at the EASL
International Liver Conference, to be hosted virtually June 23-26.
- Oral Presentation: A Phase 1 study
evaluating the neutralizing, vaccinal monoclonal antibody VIR-3434
in participants with chronic hepatitis B virus infection.
(Presenter: Dr. Kosh Agarwal)
- Oral Presentation: Safety and
antiviral activity of VIR-2218, an X-targeting RNAi therapeutic, in
participants with chronic hepatitis B infection: week 48 follow-up
results. (Presenter: Prof. Edward Gane)
- Poster Presentation: Preliminary
on-treatment data from a Phase 2 study evaluating VIR-2218 in
combination with pegylated interferon alfa-2a in participants with
chronic hepatitis B infection. (Presenter: Prof. Man-Fung
Yuen)
- Poster Presentation: Preliminary
pharmacokinetics and safety in healthy volunteers of VIR-3434, a
monoclonal antibody for the treatment of chronic hepatitis B
infection (Presenter: Dr. Sneha Gupta)
Additional Pipeline Updates
- In January, the Company initiated a
Phase 1 clinical trial of VIR-1111, an investigational HIV T cell
vaccine based on human cytomegalovirus (HCMV). This proof-of
concept trial is designed to test the hypothesis that this new
approach can elicit potentially protective immune responses that
differ from other HIV vaccines. If observed, this T cell vaccine
could potentially have utility in additional types of infections
and other challenging areas, including cancer. Initial clinical
data are anticipated in the second half of 2021.
- In February, the Company signed a
binding collaboration agreement with GSK to expand their existing
collaboration to include the research and development of new
therapies for influenza and other respiratory viruses. The expanded
collaboration, which builds on the agreement signed in 2020 to
research and develop therapies for coronaviruses, provides GSK
exclusive rights to collaborate with Vir on the development of
potential best-in-class monoclonal antibodies for the prevention or
treatment of influenza. As part of the agreement, the companies
will also engage in two additional research programs: 1) an
expansion of the current functional genomics collaboration to
include other respiratory virus targets; and 2) the development of
up to three neutralizing monoclonal antibodies identified using
Vir’s antibody technology platform to target non-influenza
pathogens during a three-year research period. Given the relatively
low incidence of influenza during the COVID-19 pandemic, the
companies are currently evaluating the potential timelines for
advancing VIR-2482 and other influenza therapies covered under the
expanded agreement. Under the terms of the agreement, GSK will pay
$345 million in a combination of an upfront payment and a further
equity investment in Vir.
PublicationsDuring and following the first
quarter, nine manuscripts were published related to the Company’s
efforts to address SARS-CoV-2 and other viruses.
In January:
- Cell published “Circulating
SARS-CoV-2 spike N439K variants maintain fitness while evading
antibody-mediated immunity” (Thompson, et al.), which was
previously posted on bioRxiv. The paper characterized the
virulence, fitness, clinical and epidemiologic impact, molecular
features and immune response to N439K, a prevalent receptor binding
motif (RBM) variant of the SARS-CoV-2 spike protein first
identified in Scotland in March 2020, and how this mutation might
evade immunity.
In February:
- medRxiv posted a pre-print
manuscript, “SARS-CoV-2 B.1.1.7 escape from mRNA vaccine-elicited
neutralizing antibodies” (Collier, et al.), which highlighted the
importance of designing next-generation vaccines with mutated S
sequences and using alternative viral antigens.
- Research Square posted a pre-print
manuscript, “SARS-CoV-2 variants show resistance to neutralization
by many monoclonal and serum-derived polyclonal antibodies”
(Diamond, et al.), which indicated that the cell line in which the
virus is grown and the cell line in which the assays are performed
significantly affected the in vitro potency of certain antibodies
against SARS-CoV-2.
In March:
- bioRxiv posted a pre-print
manuscript, “The dual function monoclonal antibodies VIR-7831 and
VIR-7832 demonstrate potent in vitro and in vivo activity against
SARS-CoV-2” (Cathcart, et al.), which demonstrated that VIR-7831
maintains activity against current circulating variants of concern
including the UK, South African and Brazilian variants.
- Cell published “N-terminal domain
antigenic mapping reveals a site of vulnerability for SARS-CoV-2”
(McCallum, et al.), which was pre-published in January on bioRxiv.
The paper characterized the N-terminal domain (NTD) on the
SARS-CoV-2 spike protein.
In April:
- bioRxiv posted a pre-print
manuscript, “SARS-CoV-2 immune evasion by variant B.1.427/B.1.429”
(McCallum, et al.), which further established the ability of
VIR-7831 to maintain its neutralizing activity against a mutation
in the receptor binding domain (RBD) of SARS-CoV-2, called L452R,
which is found in the California variant
(B.1.427/B.1.429).
- bioRxiv posted a pre-print
manuscript, “Membrane lectins enhance SARS-CoV-2 infection and
influence the neutralizing activity of different classes of
antibodies” (Lempp, et al.), which adds to the growing body of
evidence suggesting monoclonal antibodies that target a conserved
epitope, such as VIR-7831, have the potential to be highly
effective against SARS-CoV-2 and associated known mutations.
- bioRxiv posted a pre-print
manuscript, “Structural basis for broad sarbecovirus neutralization
by a human monoclonal antibody” (Tortorici, et al.), which further
recognized the importance of monoclonal antibodies with a highly
conserved epitope, broad neutralization capabilities and the
potential for a high barrier to resistance to address pan
sarbecoviruses.
- bioRxiv posted a pre-print
manuscript, “Antibodies to the SARS-CoV-2 receptor-binding domain
that maximize breadth and resistance to viral escape” (Starr, et
al.), which highlighted the importance of mAbs that target the RBD,
given their high neutralization activity and potency, and suggested
the potential for RBD-based vaccines as a means of addressing
future variants.
First Quarter 2021 Financial Results
-
Revenues: Total revenues for the quarter
ended March 31, 2021, were $2.0 million, compared to $5.7 million
for the same period in 2020. The decrease for the quarter was
primarily due to timing of research activities under our grant
agreements with the Bill & Melinda Gates Foundation.
- Research and Development
Expenses: Research and development expenses were $134.9
million for the quarter ended March 31, 2021, which includes $8.4
million of non-cash stock-based compensation expense, compared to
$65.0 million for the same period in 2020, which included $1.5
million of non-cash stock-based compensation expense. The increase
for the quarter was primarily due to clinical activities related to
VIR-7831 and VIR-2218, higher fair value of our contingent
consideration, costs incurred under our collaboration with GSK and
contract manufacturing expenses for our COVID-19 programs, and
personnel-related expenses due to additional headcount.
- General and Administrative
Expenses: General and administrative expenses were $25.7
million for the quarter ended March 31, 2021, which includes $7.0
million of non-cash stock-based compensation expense, compared to
$12.6 million for the same period in 2020, which included $1.5
million of non-cash stock-based compensation expense. The increase
for the quarter was primarily due to personnel-related expenses
attributable to additional headcount, legal fees and external
consulting expenses.
- Net Loss: Net loss
for the quarter ended March 31, 2021, was $168.9 million, or $1.32
per share, basic and diluted, compared to a net loss of $77.2
million, or $0.71 per share, basic and diluted, for the same period
in 2020.
- Cash and
Cash Equivalents: As of March 31, 2021, excluding
restricted cash, the Company had approximately $733.0 million in
cash, cash equivalents and investments. This includes $120.0
million from equity sold to GSK under the expanded collaboration
agreement signed in February 2021.
About VIR-7831VIR-7831 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 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-7831, which incorporates Xencor’s Xtend™ technology,
also has been designed to achieve high concentration in the lungs
to ensure optimal penetration into airway tissues affected by
SARS-CoV-2 and to have an extended half-life.
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
achieve high concentration in the lungs to ensure optimal
penetration into airway tissues affected by SARS-CoV-2 and 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-1111VIR-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-2482VIR-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-19Vir
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. VIR-7831 is the first SARS-CoV-2-targeting antibody we
advanced into the clinic. It was carefully selected for its
unique characteristics demonstrated during preclinical research,
including a high barrier to resistance and dual-action ability to
both block the virus from entering healthy cells and clear infected
cells. VIR-7831 has since demonstrated positive monotherapy results
in a Phase 3 clinical trial for the early treatment of COVID-19 in
high-risk adult patients, and proven in preclinical studies to
retain activity against all known circulating COVID-19 variants of
concern. 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 our
partners.
About Vir BiotechnologyVir
Biotechnology is a clinical-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. For more information,
please
visit 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” 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 the timing of
availability of clinical data, program updates and data disclosures
related to Vir’s clinical trials, the ability of VIR-7831 and
VIR-7832 to treat and/or prevent COVID-19, the ability of
VIR-7831 to be administered via an IM route, the timing and
expected number of therapeutic doses that Vir will be able to
supply to patients, the potential of Vir’s combination therapy
trials with VIR-2218 to result in a functional cure for HBV,
initial topline data from the ongoing Phase 1 trial of VIR-3434 in
the treatment of patients with HBV and VIR-3434’s potential to be a
therapeutic T cell vaccine, the ability of VIR-1111 to elicit a T
cell immune response to HIV, potential timelines for advancing
influenza therapies, including VIR-2482 and other therapies covered
under the expanded agreement with GSK. Many factors may cause
differences between current expectations and actual results,
including challenges in enrollment, 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,
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 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 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.
Contact:Cara MillerVP,
Corporate Communicationscmiller@vir.bio+1-415-941-6746
Vir Biotechnology,
Inc.Condensed Consolidated Statements of
Operations(unaudited; in thousands, except share
and per share data)
|
Three Months Ended March 31, |
|
|
2021 |
|
|
2020 |
|
Revenues: |
|
|
|
|
|
|
|
Grant revenue |
$ |
1,371 |
|
|
$ |
5,231 |
|
Contract revenue |
|
605 |
|
|
|
487 |
|
Total revenue |
|
1,976 |
|
|
|
5,718 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
134,870 |
|
|
|
64,979 |
|
General and administrative |
|
25,739 |
|
|
|
12,649 |
|
Total operating expenses |
|
160,609 |
|
|
|
77,628 |
|
Loss from operations |
|
(158,633 |
) |
|
|
(71,910 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
164 |
|
|
|
1,755 |
|
Other expense, net |
|
(10,246 |
) |
|
|
(7,069 |
) |
Total other income (expense) |
|
(10,082 |
) |
|
|
(5,314 |
) |
Loss before provision for income
taxes |
|
(168,715 |
) |
|
|
(77,224 |
) |
Provision for income taxes |
|
(196 |
) |
|
|
(16 |
) |
Net loss |
$ |
(168,911 |
) |
|
$ |
(77,240 |
) |
Net loss per share, basic and
diluted |
$ |
(1.32 |
) |
|
$ |
(0.71 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
127,742,614 |
|
|
|
108,387,913 |
|
|
|
|
|
|
|
|
|
Vir Biotechnology,
Inc.Condensed Consolidated Balance
Sheets(unaudited; in thousands, except share and
per share data)
|
March 31,2021 |
|
|
December 31,2020 |
|
ASSETS |
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
521,396 |
|
|
$ |
436,575 |
|
Short-term investments |
|
211,636 |
|
|
|
300,286 |
|
Restricted cash and cash equivalents, current |
|
8,601 |
|
|
|
7,993 |
|
Receivable from collaboration |
|
112,500 |
|
|
|
— |
|
Contract asset |
|
112,500 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
26,481 |
|
|
|
27,511 |
|
Total current assets |
|
993,114 |
|
|
|
772,365 |
|
Intangible assets, net |
|
33,687 |
|
|
|
33,820 |
|
Goodwill |
|
16,937 |
|
|
|
16,937 |
|
Property and equipment, net |
|
17,291 |
|
|
|
17,946 |
|
Operating right-of-use
assets |
|
60,461 |
|
|
|
61,947 |
|
Restricted cash and cash
equivalents, noncurrent |
|
6,998 |
|
|
|
6,919 |
|
Other assets |
|
7,096 |
|
|
|
8,827 |
|
TOTAL ASSETS |
$ |
1,135,584 |
|
|
$ |
918,761 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
|
Accounts payable |
$ |
3,701 |
|
|
$ |
5,077 |
|
Accrued and other liabilities |
|
70,069 |
|
|
|
76,936 |
|
Deferred revenue, current portion |
|
262,929 |
|
|
|
6,451 |
|
Contingent consideration, current portion |
|
24,400 |
|
|
|
10,600 |
|
Total current liabilities |
|
361,099 |
|
|
|
99,064 |
|
Deferred revenue, noncurrent |
|
3,815 |
|
|
|
3,815 |
|
Operating lease liabilities,
noncurrent |
|
66,615 |
|
|
|
66,556 |
|
Contingent consideration,
noncurrent |
|
46,036 |
|
|
|
25,374 |
|
Deferred tax liability |
|
3,253 |
|
|
|
3,253 |
|
Other long-term liabilities |
|
3,815 |
|
|
|
3,847 |
|
TOTAL LIABILITIES |
|
484,633 |
|
|
|
201,909 |
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
|
Preferred stock, $0.0001 par
value; 10,000,000 shares authorized as of March 31, 2021 and
December 31, 2020; no shares issued and outstanding as of March 31,
2021 and December 31, 2020 |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value;
300,000,000 shares authorized as of March 31, 2021 and December 31,
2020; 129,891,856 and 127,416,740 shares issued and outstanding as
of March 31, 2021 and December 31, 2020, respectively |
|
13 |
|
|
|
13 |
|
Additional paid-in capital |
|
1,488,337 |
|
|
|
1,385,301 |
|
Accumulated other comprehensive
loss |
|
(1,304 |
) |
|
|
(1,278 |
) |
Accumulated deficit |
|
(836,095 |
) |
|
|
(667,184 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
650,951 |
|
|
|
716,852 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
1,135,584 |
|
|
$ |
918,761 |
|
Vir Biotechnology (NASDAQ:VIR)
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