- Biomedical Advanced Research and Development Authority (BARDA) awarded contract to support pandemic preparedness for influenza and other infectious diseases; initial investment of ~$55.0 million with potential total of up to $1.0 billion -
- Phase 2 data from three of the Company’s most advanced development programs – hepatitis B, hepatitis D and influenza A – expected in 2023 -
- Strong balance sheet with approximately $2.7 billion in cash, cash equivalents, investments and profit-share payments to be received from GSK expected to fund the Company’s innovative portfolio for several years through key inflection points -
SAN FRANCISCO, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the third quarter ended September 30, 2022.
“Throughout the quarter and into October, Vir achieved several important milestones that are critical to advancing new therapies designed to address the world’s’ most serious infectious diseases,” said George Scangos, Ph.D., chief executive officer of Vir. “We are honored to have been chosen by BARDA to partner broadly on pandemic preparedness and to have their immediate support of our groundbreaking Phase 2 trial for the prevention of influenza A, which we initiated in October. Simultaneously, we continued to advance our hepatitis pipeline with the initiation of our Phase 2 trial in hepatitis D, the most aggressive form of hepatitis. Initial data from both trials are expected in 2023. Together with other highly anticipated read-outs from our hepatitis B, COVID-19 and HIV programs, we believe 2023 will be a transformational year for Vir that brings us closer to delivering meaningful therapies to patients around the world.”
Corporate Update
General – advancing key collaborations with government and industry
COVID-19 – continuing to respond to the global pandemic
Hepatitis B Virus (HBV) – data expected from multiple trials in the near-term
Hepatitis D Virus (HDV) – novel combination strategy with significant promise for patients
Influenza – groundbreaking prophylaxis trial underway
HIV – advancing novel solutions for this intractable public health challenge
Third Quarter 2022 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 Emergency Use Authorization (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.
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.
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. On April 5, 2022, the FDA updated the EUA to provide that sotrovimab is no longer authorized to treat COVID-19 in any US region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant.
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 and HDV. 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 antibody designed to block entry of HBV and HDV viruses into hepatocytes and 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 and HDV in infected patients, as well as to have an extended half-life.
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 address 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. Under the collaboration agreement signed with GSK in 2021, GSK has an exclusive option to lead post-Phase 2 development and commercialization of VIR-2482.
The development of VIR-2482 is funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50122C00081.
About VIR-1111
VIR-1111 is an investigational subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit abundant T cells that recognize HIV epitopes in a way that differs from prior HIV vaccines.
About VIR-1388
VIR-1388 is a preclinical 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’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 and hepatitis D viruses, 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,” “expect,” “anticipate,” “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 strategy and plans; Vir’s capital allocation; Vir’s future financial and operating results and its expectations related thereto; potential of, and expectations for, Vir’s pipeline; Vir’s clinical development programs, clinical trials, including the enrollment of Vir’s clinical trials, and data readouts and presentations; testing the ability of sotrovimab to maintain activity against new variants and subvariants of COVID-19; Vir’s plans for sotrovimab and its COVID-19 portfolio; clinical data from Vir’s ongoing trials of VIR-2218 and VIR-3434; the ability of VIR-2218 and VIR-3434 (as monotherapies or combination therapies) to treat and/or prevent chronic HBV infection or treat HDV infection; the potential benefits of VIR-2482 to protect against seasonal and pandemic influenza; Vir’s collaboration with BARDA; and Vir’s plans for its HBV, HDV, influenza and HIV portfolios. Many important factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the timing and outcome of Vir’s planned interactions with regulatory authorities; difficulties in obtaining regulatory approval; uncertainty as to whether the anticipated benefits of Vir’s collaborations with other companies can be achieved; difficulties in collaborating with other companies; challenges in accessing manufacturing capacity; clinical site activation rates or clinical trial enrollment rates that are lower than expected; 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 (including the war in Ukraine) or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. 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.
Vir Biotechnology, Inc.
Condensed Consolidated Statements of Operations
(unaudited; in thousands, except share and per share data) Three Months Ended
September 30, Nine Months Ended
September 30, 2022 2021 2022 2021 Revenue: Collaboration revenue$309,145 $102,398 $1,483,860 $107,731 Contract revenue 39,998 315 52,534 169,581 License revenue from a related party 22,289 — 22,289 — Grant revenue 3,125 903 7,704 5,356 Total revenue 374,557 103,616 1,566,387 282,668 Operating expenses: Cost of revenue 22,253 7,836 140,323 8,988 Research and development 114,166 98,669 319,475 319,665 Selling, general and administrative 43,174 50,496 123,019 105,016 Total operating expenses 179,593 157,001 582,817 433,669 Income (loss) from operations 194,964 (53,385) 983,570 (151,001)Other income (expense): Change in fair value of equity investments (13,590) 164,072 (120,019) 164,072 Interest income 9,332 11 11,920 272 Other income (expense), net 27,026 64 30,447 (9,430)Total other income (expense) 22,768 164,147 (77,652) 154,914 Income before provision for income taxes 217,732 110,762 905,918 3,913 Provision for income taxes (42,420) (334) (288,478) (583)Net income$175,312 $110,428 $617,440 $3,330 Net income per share, basic$1.32 $0.85 $4.66 $0.03 Net income per share, diluted$1.30 $0.82 $4.58 $0.02 Weighted-average shares outstanding, basic 132,729,530 130,665,831 132,422,028 129,520,837 Weighted-average shares outstanding, diluted 134,963,317 133,854,419 134,711,777 133,318,979
Vir Biotechnology, Inc.
Condensed Consolidated Balance Sheets
(unaudited; in thousands, except share and per share data) September 30,
2022 December 31,
2021 ASSETS CURRENT ASSETS: Cash and cash equivalents$963,735 $347,815 Short-term investments 1,359,945 217,182 Restricted cash and cash equivalents, current 12,955 8,594 Receivable from collaboration — 773,079 Equity investments 22,801 143,148 Prepaid expenses and other current assets 54,180 73,003 Total current assets 2,413,616 1,562,821 Intangible assets, net 32,888 33,287 Goodwill 16,937 16,937 Property and equipment, net 100,226 42,834 Operating right-of-use assets 84,716 87,220 Restricted cash and cash equivalents, noncurrent 7,276 7,006 Long-term investments 34,102 201,388 Other assets 6,209 2,775 TOTAL ASSETS$2,695,970 $1,954,268 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable$2,722 $6,521 Accrued and other liabilities 282,616 236,512 Deferred revenue, current portion 22,865 98,209 Total current liabilities 308,203 341,242 Deferred revenue, noncurrent 54,653 3,815 Operating lease liabilities, noncurrent 126,942 133,561 Contingent consideration, noncurrent 30,712 22,822 Deferred tax liability 18,439 18,439 Other long-term liabilities 7,166 2,540 TOTAL LIABILITIES 546,115 522,419 STOCKHOLDERS’ EQUITY: Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of September 30, 2022 and December 31, 2021; no shares issued and outstanding as of September 30, 2022 and December 31, 2021 — — Common stock, $0.0001 par value; 300,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 133,027,358 and 131,161,404 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively 13 13 Additional paid-in capital 1,682,882 1,571,535 Accumulated other comprehensive loss (11,880) (1,099)Retained earnings (accumulated deficit) 478,840 (138,600)TOTAL STOCKHOLDERS’ EQUITY 2,149,855 1,431,849 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY$2,695,970 $1,954,268
Contact: Carly Scaduto Senior Director, Media Relations cscaduto@vir.bio +1-314-368-5189