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Vir Biotechnology, Inc.
Vir Biotechnology Provides Corporate Update and Reports First Quarter 2022 Financial Results
Business
May 5 2022
5 min read

Vir Biotechnology Provides Corporate Update and Reports First Quarter 2022 Financial Results

– $1.2 billion of sotrovimab collaboration revenue recognized in the first quarter –

– More than $2.5 billion in cash, cash equivalents, investments and collaboration receivables at the end of the first quarter –

– Encouraging initial data from MARCH trial evaluating hepatitis B functional cure shared in April –

– Multiple value drivers in COVID-19, hepatitis B, hepatitis D, HIV and influenza expected in 2022 –

SAN FRANCISCO, May 05, 2022 (GLOBE NEWSWIRE) -- 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 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 (