Full Press Release Details
Vir Biotechnology Provides Corporate Update and Reports
Fourth Quarter and Full Year 2021 Financial Results
Significant progress made increasing global patient access to sotrovimab;
approximately 1.7 million doses sold to date
$917.2 million of sotrovimab collaboration revenue recognized in 2021
Multiple commercial and clinical value drivers expected across the portfolio in 2022
SAN FRANCISCO, Feb. 24, 2022 Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the fourth
quarter and full year ended December 31, 2021.
2021 was a transformative year in which we delivered our first blockbuster medicine,
sotrovimab, to COVID-19 patients as a result of prescient scientific insights from our R&D team and the rapid development and disciplined execution of an integrated strategy by the entire company alongside
our collaborator, GSK. Simultaneously, we continued to advance our robust and diverse portfolio of compounds with the potential to address hepatitis B, influenza A, HIV and more, with multiple clinical value drivers expected in 2022, said
George Scangos, Ph.D., chief executive officer of Vir Biotechnology.
Dr. Scangos added, In the year ahead, we plan to share important data
readouts from multiple Phase 2 combination trials aimed at developing a functional cure for HBV; report additional data from our Phase 1 study evaluating our HIV T cell vaccine; initiate a Phase 2 trial for our potential universal prophylaxis for
influenza A; report new data evaluating sotrovimab as prophylaxis for immunocompromised COVID-19 patients and as treatment for hospitalized COVID-19 patients; and
advance new innovative pan-coronavirus solutions. Importantly, our strong cash position allows us the flexibility to invest in additional internal and external opportunities.
Chronic Hepatitis B Virus (HBV)
Fourth Quarter and Full Year 2021 Financial Results
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 EUA. Please see the 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
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
authorized for use in patients:
Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID19. 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
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
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 (eg, 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 (eg, pre-syncope, syncope), dizziness and diaphoresis.
Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs.
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 (eg, 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.
Hypersensitivity adverse reactions have been observed in 2% of patients treated with sotrovimab and 1% with placebo in
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). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo.
USE IN SPECIFIC POPULATIONS
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 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.
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.
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.
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.
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.
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 preclinical 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. 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, 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 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 ability of sotrovimab
and VIR-7832 to treat and/or prevent COVID-19, the ability of sotrovimab to be administered via an IV and an IM route, 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 circulating variants of concern and
interest, including Omicron and 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, Vir s collaboration with Gilead to
evaluate VIR-2218 in a combination therapy trial with GS-9688, 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, 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