Full Press Release Details
Vir Biotechnology Provides Corporate Update and
Reports Fourth Quarter and Full Year 2019 Financial Results
SAN FRANCISCO - March 26, 2020 - Vir Biotechnology, Inc. (Nasdaq: VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2019.
"2019 was a very successful year of growth and progress for Vir, as we expanded our clinical and preclinical pipeline, built a robust research engine around our multiple platforms for fighting infectious disease, and completed an initial public offering," said George Scangos, Ph.D., Chief Executive Officer of Vir. "In 2020, the value of our multi-platform approach has become evident as we rapidly execute our scientific strategy in pursuit of therapies for the COVID-19 pandemic, while simultaneously maintaining sharp focus on our ongoing programs in hepatitis B, influenza A, and HIV."
Fourth Quarter & Full Year 2019 Financial Results
VIR-2218 is a 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-2482 is an 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 prophylaxis 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 has been half-life engineered so that a single dose has the potential to last the entire flu season, which is typically five to six months long.
VIR-3434 is a 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 has been engineered to have an extended half-life as well as to potentially function as a T cell vaccine against HBV in infected patients.
VIR-1111 is a subcutaneously administered HIV T cell vaccine based on human cytomegalovirus (HCMV) that has been designed to elicit T cells that recognize HIV epitopes that are different from those recognized by prior HIV vaccines and to stimulate a different and specific type of T cell immune response to HIV, known as an HLA-E restricted immune response.
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 hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. 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," "expect," "plan," "anticipate," "estimate," "intend," "potential" 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing of commencement of clinical trials, program updates and data disclosures for the company's clinical trials, the ability of the company's antibodies to neutralize the SARS-CoV-2 virus, the company's efforts to identify additional antibodies, the timing of manufacturing a product candidate to treat COVID-19, the potential benefits of the company's collaborations with Wuxi Biologics, Biogen and Alnylam, including whether or not any DCs will be identified and selected and whether or not any DCs will be successfully developed and commercialized under the Alnylam collaboration, the company's ability to enter into an agreement with Biogen, and the company's ability to address the COVID-19 pandemic. 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 neutralizing SARS-CoV-2, challenges in identifying and selecting DCs, difficulty in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, clinical site activation rates or clinical trial enrollment rates that are lower than expected, changes in expected or existing competition, delays or disruptions on our business or clinical trials due to the COVID-19 pandemic, 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 U.S. 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.
Head of Investor Relations & Strategic 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, | ||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Revenue: | |||||||||||||||
| Grant revenue | $ | 609 | $ | 3,119 | $ | 7,380 | $ | 9,800 | |||||||
| Contract revenue | 371 | 7 | 711 | 868 | |||||||||||
| Total revenue | 980 | 3,126 | 8,091 | 10,668 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 52,932 | 21,973 | 148,472 | 100,229 | |||||||||||
| General and administrative | 11,807 | 7,949 | 37,598 | 29,131 | |||||||||||
| Total operating expenses | 64,739 | 29,922 | 186,070 | 129,360 | |||||||||||
| Loss from operations | (63,759 | ) | (26,796 | ) | (177,979 | ) | (118,692 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Interest income | 1,947 | 621 | 8,511 | 2,540 | |||||||||||
| Other income (expense), net | (1,810 | ) | (198 | ) | (5,061 | ) | (212 | ) | |||||||
| Total other income (expense) | 137 | 423 | 3,450 | 2,328 | |||||||||||
| Loss before benefit from (provision for) income taxes | (63,622 | ) | (26,373 | ) | (174,529 | ) | (116,364 | ) | |||||||
| Benefit from (provision for) income taxes | (149 | ) | (20 | ) | (154 | ) | 480 | ||||||||
| Net loss | $ | (63,771 | ) | $ | (26,393 | ) | $ | (174,683 | ) | $ | (115,884 | ) | |||
| Net loss per share, basic | $ | (0.69 | ) | $ | (3.05 | ) | $ | (5.76 | ) | $ | (15.12 | ) | |||
| Net loss per share, diluted | $ | (0.71 | ) | $ | (3.05 | ) | $ | (5.76 | ) | $ | (15.12 | ) | |||
| Weighted-average shares outstanding, basic | 91,871,498 | 8,653,054 | 30,349,920 | 7,666,463 | |||||||||||
| Weighted-average shares outstanding, diluted | 91,901,590 | 8,653,054 | 30,349,920 | 7,666,463 |
Vir Biotechnology, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 109,335 | $ | 47,598 | ||||
| Short-term investments | 274,101 | 50,845 | ||||||
| Restricted cash and cash equivalents, current | 6,181 | 10,761 | ||||||
| Prepaid expenses and other current assets | 13,378 | 8,579 | ||||||
| Total current assets | 402,995 | 117,783 | ||||||
| Intangible assets, net | 35,694 | 36,917 | ||||||
| Goodwill | 16,937 | 16,937 | ||||||
| Property and equipment, net | 16,308 | 12,290 | ||||||
| Restricted cash and cash equivalents, noncurrent | 7,300 | 1,003 | ||||||
| Long-term investments | 24,290 | - | ||||||
| Other assets | 8,547 | 6,666 | ||||||
| TOTAL ASSETS | $ | 512,071 | $ | 191,596 | ||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 5,881 | $ | 6,473 | ||||
| Accrued liabilities | 26,495 | 14,534 | ||||||
| Deferred revenue, current | 6,181 | 8,761 | ||||||
| Advanced proceeds from preferred stock financing | - | 10,140 | ||||||
| Contingent consideration, current | 8,200 | - | ||||||
| Derivative liability | 12,449 | - | ||||||
| Total current liabilities | 59,206 | 39,908 | ||||||
| Deferred revenue, noncurrent | 12,670 | 6,561 | ||||||
| Convertible preferred stock warrant liability | - | 1,024 | ||||||
| Contingent consideration, noncurrent | 9,380 | 9,250 | ||||||
| Deferred tax liability | 3,305 | 3,305 | ||||||
| Other long-term liabilities | 3,568 | 1,588 | ||||||
| TOTAL LIABILITIES | 88,129 | 61,636 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred stock, $0.0001 par value; zero and 421,450,000 shares authorized as of December 31, 2019 and 2018, respectively; zero and 69,910,520 shares issued and outstanding as of December 31, 2019 and 2018, respectively; aggregate liquidation preference of zero and $333,058 as of December 31, 2019 and 2018, respectively | - | 309,137 | ||||||
| STOCKHOLDERS' EQUITY (DEFICIT): | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 and zero shares authorized as of December 31, 2019 and 2018; no shares issued or outstanding as of December 31, 2019 and 2018 | - | - | ||||||
| Common stock, $0.0001 par value; 300,000,000 and 558,350,000 shares authorized as of December 31, 2019 and 2018, respectively; 107,648,925, and 8,858,799 shares issued and outstanding as of December 31, 2019 and 2018, respectively | 11 | 1 | ||||||
| Additional paid-in capital | 793,051 | 14,672 | ||||||
| Accumulated other comprehensive loss | (601 | ) | (14 | ) | ||||
| Accumulated deficit | (368,519 | ) | (193,836 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY (DEFICIT) | 423,942 | (179,177 | ) | |||||
| TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) | $ | 512,071 | $ | 191,596 |