UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 5, 2022, Vir Biotechnology, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits |
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Exhibit No. |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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VIR BIOTECHNOLOGY, INC. |
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Date: |
May 5, 2022 |
By: |
/s/ Howard Horn |
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Howard Horn |
Exhibit-99.1
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 5, 2022 – 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
1
Hepatitis B Virus (HBV)
2
Hepatitis D Virus (HDV)
Other Pipeline
Management
3
Publications
First Quarter 2022 Financial Results
4
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
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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:
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.
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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.
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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.
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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
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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.
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
10
Vir Biotechnology, Inc.
Condensed Consolidated Statements of Operations
(unaudited; in thousands, except share and per share data)
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Three Months Ended March 31, |
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2022 |
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2021 |
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Revenue: |
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Collaboration revenue |
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$ |
1,229,656 |
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$ |
— |
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Contract revenue |
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282 |
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605 |
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Grant revenue |
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2,521 |
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1,371 |
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Total revenue |
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1,232,459 |
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1,976 |
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Operating expenses: |
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Cost of revenue |
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90,149 |
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— |
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Research and development |
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90,227 |
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134,870 |
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Selling, general and administrative |
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38,255 |
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25,739 |
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Total operating expenses |
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218,631 |
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160,609 |
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Income (loss) from operations |
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1,013,828 |
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(158,633 |
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Other income (expense): |
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Change in fair value of equity investments |
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(95,039 |
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— |
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Interest income |
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388 |
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164 |
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Other income (expense), net |
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2,730 |
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(10,246 |
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Total other expense |
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(91,921 |
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(10,082 |
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Income (loss) before provision for income taxes |
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921,907 |
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(168,715 |
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Provision for income taxes |
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(403,286 |
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(196 |
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Net income (loss) |
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$ |
518,621 |
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$ |
(168,911 |
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Net income (loss) per share, basic |
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$ |
3.93 |
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$ |
(1.32 |
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Net income (loss) per share, diluted |
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$ |
3.85 |
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$ |
(1.32 |
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Weighted-average shares outstanding, basic |
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132,079,391 |
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127,742,614 |
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Weighted-average shares outstanding, diluted |
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134,535,766 |
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127,742,614 |
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Vir Biotechnology, Inc.
Condensed Consolidated Balance Sheets
(unaudited; in thousands, except share and per share data)
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March 31, |
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December 31, |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
812,355 |
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$ |
347,815 |
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Short-term investments |
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399,829 |
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217,182 |
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Restricted cash and cash equivalents, current |
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14,402 |
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8,594 |
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Receivable from collaboration |
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1,223,161 |
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773,079 |
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Equity investments |
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47,890 |
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143,148 |
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Prepaid expenses and other current assets |
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69,911 |
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73,003 |
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Total current assets |
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2,567,548 |
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1,562,821 |
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Intangible assets, net |
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33,154 |
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33,287 |
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Goodwill |
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16,937 |
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16,937 |
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Property and equipment, net |
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65,583 |
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42,834 |
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Operating right-of-use assets |
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88,331 |
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87,220 |
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Restricted cash and cash equivalents, noncurrent |
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9,040 |
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7,006 |
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Long-term investments |
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103,535 |
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201,388 |
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Other assets |
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3,001 |
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2,775 |
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TOTAL ASSETS |
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$ |
2,887,129 |
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$ |
1,954,268 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable |
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$ |
10,955 |
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$ |
6,521 |
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Accrued and other liabilities |
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577,669 |
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236,512 |
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Deferred revenue, current portion |
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113,737 |
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98,209 |
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Contingent consideration, current portion |
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— |
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— |
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Total current liabilities |
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702,361 |
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341,242 |
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Deferred revenue, noncurrent |
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5,865 |
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3,815 |
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Operating lease liabilities, noncurrent |
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132,813 |
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|
133,561 |
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Contingent consideration, noncurrent |
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18,891 |
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|
22,822 |
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Deferred tax liability |
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18,439 |
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18,439 |
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Other long-term liabilities |
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7,746 |
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2,540 |
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TOTAL LIABILITIES |
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886,115 |
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522,419 |
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STOCKHOLDERS’ EQUITY: |
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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 |
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— |
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— |
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Common stock, $0.0001 par value; 300,000,000 shares authorized as of March 31, 2022 and December 31, 2021; 132,353,441 and 131,161,404 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively |
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13 |
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13 |
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Additional paid-in capital |
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1,625,785 |
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1,571,535 |
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Accumulated other comprehensive loss |
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(4,805 |
) |
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(1,099 |
) |
Retained earnings (accumulated deficit) |
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380,021 |
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(138,600 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
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2,001,014 |
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|
|
1,431,849 |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
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$ |
2,887,129 |
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|
$ |
1,954,268 |
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12