Invivyd Provides PEMGARDA Launch Update and Announces 2024 Net Product Revenue Guidance in the Range of $150 Million to $200 Million

• PEMGARDA now commercially available in the U.S. for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise

• Based on anticipated net product revenue and continued optimization of operational expenses, company expects to end 2024 with at least $55 million in cash and cash equivalents
• Conference call today at 5 pm ET to discuss PEMGARDA launch progress
  

WALTHAM, Mass., April 04, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that PEMGARDA is now available for purchase in the U.S.

On March 22, 2024, PEMGARDA (pemivibart) injection, for intravenous use, received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

"I am very pleased to announce that, in less than two weeks from receiving EUA, PEMGARDA is now commercially available for order across the U.S.,” said Dave Hering, Chief Executive Officer. "This is a remarkable achievement for our organization and for the immunocompromised individuals we serve. With product now available, today we are providing initial PEMGARDA net product revenue guidance in the range of $150 million to $200 million for the full year 2024. Based on this anticipated net product revenue and our continued optimization of operating expenses, we expect to end 2024 with at least $55 million in cash and cash equivalents.”

PEMGARDA is available by prescription through a network of authorized specialty distributors. Healthcare professionals seeking to obtain PEMGARDA for their patients should contact their primary vendor for ordering information or contact Invivyd at 1-800-890-3385 for more information. For additional information about PEMGARDA, please see the full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning.