Full Press Release Details
Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2020 Financial Results
SAN FRANCISCO, February 25, 2021 - Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2020.
"Vir closed 2020 delivering strong progress across our entire development pipeline with six distinct molecules addressing four serious infectious diseases. Our momentum continues in 2021 with the signing of new collaborations designed to help speed the development of multiple promising candidates, as well as pending data from two Phase 3 studies evaluating our novel monoclonal antibody, VIR-7831, against COVID-19," said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. "Additionally, we are now evaluating an intramuscular formulation of VIR-7831, and expect the first trial evaluating VIR-7832, our second antibody aimed at COVID-19, to begin shortly. Vir's strong execution is evident across our full portfolio, with the recent compelling initial data from our Phase 1 trial of VIR-3434 demonstrating a significant and rapid reduction in hepatitis B surface antigen, and the continued forward momentum of our influenza and HIV programs. We anticipate a transformational year ahead."
Expanded GSK Collaboration
Chronic Hepatitis B Virus (HBV) Updates
Additional Pipeline Updates
During and following the fourth quarter, seven manuscripts were published related to the Company's efforts to address SARS-CoV-2 and other viruses.
New Board Appointment
Fourth Quarter and Full Year 2020 Financial Results
VIR-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.
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.
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-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-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 Biotechnology
Vir 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 and 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-2482 to provide broad strain coverage for the flu, [and] the ability of VIR-1111 to elicit a T cell immune response to HIV. 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, 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.
VP, Corporate Communications
Vir Biotechnology, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Revenue: | |||||||||||||||
| Grant revenue | $ | 1,433 | $ | 609 | $ | 9,123 | $ | 7,380 | |||||||
| License revenue from a related party | - | - | 22,747 | $ | - | ||||||||||
| Contract revenue | 301 | 371 | 44,498 | 711 | |||||||||||
| Total revenue | 1,734 | 980 | 76,368 | 8,091 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 87,095 | 52,932 | 302,411 | 148,472 | |||||||||||
| General and administrative | 23,043 | 11,807 | 70,937 | 37,598 | |||||||||||
| Total operating expenses | 110,138 | 64,739 | 373,348 | 186,070 | |||||||||||
| Loss from operations | (108,404 | ) | (63,759 | ) | (296,980 | ) | (177,979 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Interest income | 288 | 1,947 | 2,836 | 8,511 | |||||||||||
| Other income (expense), net | 2,437 | (1,810 | ) | (4,467 | ) | (5,061 | ) | ||||||||
| Total other income (expense) | 2,725 | 137 | (1,631 | ) | 3,450 | ||||||||||
| Loss before benefit from (provision for) income taxes | (105,679 | ) | (63,622 | ) | (298,611 | ) | (174,529 | ) | |||||||
| Benefit from (provision for) income taxes | 30 | (149 | ) | (54 | ) | (154 | ) | ||||||||
| Net loss | $ | (105,649 | ) | $ | (63,771 | ) | $ | (298,665 | ) | $ | (174,683 | ) | |||
| Net loss per share, basic | $ | (0.83 | ) | $ | (0.69 | ) | $ | (2.51 | ) | $ | (5.76 | ) | |||
| Net loss per share, diluted | $ | (0.83 | ) | $ | (0.71 | ) | $ | (2.51 | ) | $ | (5.76 | ) | |||
| Weighted-average shares outstanding, basic | 127,295,719 | 91,871,498 | 119,159,424 | 30,349,920 | |||||||||||
| Weighted-average shares outstanding, diluted | 127,295,719 | 91,901,590 | 119,159,424 | 30,349,920 |
Vir Biotechnology, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
| December 31, | ||||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 436,575 | $ | 109,335 | ||||
| Short-term investments | 300,286 | 274,101 | ||||||
| Restricted cash and cash equivalents, current | 7,993 | 6,181 | ||||||
| Prepaid expenses and other current assets | 27,511 | 13,378 | ||||||
| Total current assets | 772,365 | 402,995 | ||||||
| Intangible assets, net | 33,820 | 35,694 | ||||||
| Goodwill | 16,937 | 16,937 | ||||||
| Property and equipment, net | 17,946 | 16,308 | ||||||
| Operating right-of-use assets | 61,947 | - | ||||||
| Restricted cash and cash equivalents, noncurrent | 6,919 | 7,300 | ||||||
| Long-term investments | - | 24,290 | ||||||
| Other assets | 8,827 | 8,547 | ||||||
| TOTAL ASSETS | $ | 918,761 | $ | 512,071 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 5,077 | $ | 5,881 | ||||
| Accrued and other liabilities | 76,936 | 26,495 | ||||||
| Deferred revenue, current portion | 6,451 | 6,181 | ||||||
| Contingent consideration, current portion | 10,600 | 8,200 | ||||||
| Derivative liability | - | 12,449 | ||||||
| Total current liabilities | 99,064 | 59,206 | ||||||
| Deferred revenue, noncurrent | 3,815 | 12,670 | ||||||
| Operating lease liabilities, noncurrent | 66,556 | - | ||||||
| Contingent consideration, noncurrent | 25,374 | 9,380 | ||||||
| Deferred tax liability | 3,253 | 3,305 | ||||||
| Other long-term liabilities | 3,847 | 3,568 | ||||||
| TOTAL LIABILITIES | 201,909 | 88,129 | ||||||
| Commitments and contingencies | ||||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of December 31, 2020 and 2019; no shares issued or outstanding as of December 31, 2020 and 2019 | - | - | ||||||
| Common stock, $0.0001 par value; 300,000,000 shares authorized as of December 31, 2020 and 2019, respectively; 127,416,740 and 107,648,925 shares issued and outstanding as of December 31, 2020 and 2019, respectively | 13 | 11 | ||||||
| Additional paid-in capital | 1,385,301 | 793,051 | ||||||
| Accumulated other comprehensive loss | (1,278 | ) | (601 | ) | ||||
| Accumulated deficit | (667,184 | ) | (368,519 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 716,852 | 423,942 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 918,761 | $ | 512,071 |