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Invivyd | 8-K: INVIVYD REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS

SEC ·  Aug 14 20:24

Summary by Futu AI

On August 14, 2024, Invivyd, Inc., a biopharmaceutical company, reported its financial results for the second quarter ended June 30, 2024, and provided an update on recent business highlights. The company announced a net product revenue of $2.3 million following the commercial launch of PEMGARDA™, a monoclonal antibody for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised patients. Invivyd also noted a notable acceleration of commercial results in early Q3 2024, with the anticipation of the peak fall/winter respiratory virus season. The company has achieved Medicare and Medicaid coverage for PEMGARDA and has seen rapid growth in commercial coverage across national and regional plans, as well as strong growth in infusion center utilization. An Emergency Use Authorization (EUA) amendment request was submitted to the U...Show More
On August 14, 2024, Invivyd, Inc., a biopharmaceutical company, reported its financial results for the second quarter ended June 30, 2024, and provided an update on recent business highlights. The company announced a net product revenue of $2.3 million following the commercial launch of PEMGARDA™, a monoclonal antibody for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised patients. Invivyd also noted a notable acceleration of commercial results in early Q3 2024, with the anticipation of the peak fall/winter respiratory virus season. The company has achieved Medicare and Medicaid coverage for PEMGARDA and has seen rapid growth in commercial coverage across national and regional plans, as well as strong growth in infusion center utilization. An Emergency Use Authorization (EUA) amendment request was submitted to the U.S. FDA for PEMGARDA for the treatment of mild-to-moderate COVID-19 in certain immunocompromised patients. Additionally, the first-in-human clinical trial dosing for a next-generation molecule, VYD2311, is scheduled to begin in late August. Invivyd ended Q2 2024 with cash and cash equivalents of $147.9 million and expects to end 2024 with at least $75 million in cash and cash equivalents. The company's R&D expenses for the quarter were $30.3 million, a decrease from the previous year, while SG&A expenses increased to $21.1 million due to the commercial launch of PEMGARDA. The net loss for the quarter was $47.2 million, with a net loss per share of $0.40. Invivyd has added new commercial leadership and board members to strengthen its commercial and organizational expertise.

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