Vir(US:VIR)2024-11-04 21:09Financial Performance - Total revenues for the three months ended September 30, 2024, were $2,380,000, a decrease from $2,639,000 in the same period of 2023[14] - The net loss for the three months ended September 30, 2024, was $213,717,000, compared to a net loss of $163,413,000 for the same period in 2023, representing an increase of approximately 30%[14] - The company reported a net loss per share attributable to Vir of $(1.56) for the three months ended September 30, 2024, compared to $(1.22) for the same period in 2023[14] - As of September 30, 2023, the company reported a net loss of $499.1 million, compared to a net loss of $417.4 million for the nine months ended September 30, 2024[21][23] - Total revenues for the nine months ended September 30, 2024, were $61,831 thousand, down from $69,393 thousand in the same period of 2023, a decrease of $7,562 thousand[125] - Net loss for Q3 2024 was $(213,717) thousand compared to $(163,413) thousand in Q3 2023, an increase in loss of $50,304 thousand[125] Expenses - Research and development expenses for the nine months ended September 30, 2024, were $400,416,000, compared to $470,754,000 for the same period in 2023, reflecting a decrease of approximately 15%[14] - The company reported a total operating expense of $233,684,000 for the three months ended September 30, 2024, an increase from $189,371,000 in the same period of 2023[14] - Research and development expenses for Q3 2024 increased to $195,178 thousand from $145,028 thousand in Q3 2023, an increase of $50,150 thousand[129] - Selling, general and administrative expenses for Q3 2024 decreased to $25,744 thousand from $40,933 thousand in Q3 2023, a decrease of $15,189 thousand[125] - Total operating expenses for the nine months ended September 30, 2024, were $531,846 thousand, down from $614,682 thousand in the same period of 2023, a decrease of $82,836 thousand[125] - The company incurred restructuring expenses of approximately $10.4 million in Q3 2024, with $8.2 million classified as research and development expenses[82] Equity and Liabilities - Total stockholders' equity as of September 30, 2024, was $1,240,727,000, down from $1,590,236,000 as of December 31, 2023[11] - The accumulated deficit as of September 30, 2024, was $(655,195,000), compared to $(237,824,000) as of December 31, 2023[11] - The total liabilities and stockholders' equity as of September 30, 2024, were $1,498,356,000, down from $1,919,060,000 as of December 31, 2023[11] - The company had no debt outstanding as of September 30, 2024, indicating a strong liquidity position[149] Cash Flow - The company had $1.19 billion in cash, cash equivalents, and investments as of September 30, 2024, which is expected to fund operations for at least the next twelve months[26] - The company reported net cash used in operating activities of $358.7 million for the nine months ended September 30, 2024, a decrease from $670.9 million for the same period in the previous year[23] - Cash, cash equivalents, and investments totaled $1.19 billion as of September 30, 2024, with an accumulated deficit of $655.2 million[137] - Cash provided by investing activities increased to $358.6 million for the nine months ended September 30, 2024, compared to $269.4 million in 2023[143] Research and Development - The company has a clinical development pipeline targeting hepatitis delta virus (HDV) and hepatitis B virus (HBV), along with multiple oncology programs[25] - Research and development expenses primarily relate to discovery efforts and clinical development, with costs recognized as incurred[43] - The company recognized additional net research and development expenses of $1 million and $6.1 million during the three months ended September 30, 2024 and 2023, respectively, under the 2020 GSK Agreement[76] Grants and Collaborations - The Company has been awarded grants totaling up to $49.9 million from the Bill & Melinda Gates Foundation to support various vaccine programs[64] - Under the BARDA Agreement, the Company may receive up to $1.0 billion, with $55.0 million allocated for the development of VIR-2482[65] - The Company recognized grant revenue related to BARDA of $0.5 million and $2.9 million for the three months ended September 30, 2024 and 2023, respectively[67] Strategic Initiatives - The company entered into a sales agreement to offer and sell shares of its common stock for an aggregate offering price of up to $300 million[26] - The company announced a workforce reduction of approximately 25%, equating to about 140 employees, as part of a strategic shift[108] - The company expects to recognize restructuring expenses of approximately $11 million to $13 million primarily related to employee severance cash payouts in the second half of 2024[82] Future Outlook - The company does not expect significant revenue from product candidates until regulatory approvals are obtained, with a nominal amount of collaboration revenue anticipated in 2024[111] - The FDA has excluded the use of sotrovimab in all U.S. regions, leading to uncertainty regarding future collaboration revenue from this product[112] - The company plans to present additional data from the Phase 2 chronic hepatitis delta SOLSTICE trial in November 2024, involving approximately 60 patients[105]