Adagio(IVVD) - 2025 Q4 - Annual Results

Financial Performance - Preliminary Q4 2025 net product revenue for PEMGARDA® (pemivibart) was $17.2 million, reflecting a 25% increase year-over-year and a 31% increase quarter-over-quarter[5]. - The company ended 2025 with cash and cash equivalents of $226.7 million after raising over $200 million in financing during the second half of 2025[5]. - The company anticipates preliminary fourth quarter financial results for Q4 2025, with potential changes upon finalization of financial statements[25]. - Total shares of common stock outstanding as of December 31, 2025, were 281,987,033, excluding pre-funded warrants[12]. Clinical Trials and Development - The DECLARATION Phase 3 pivotal clinical trial for VYD2311 has been initiated, with top-line data expected in mid-2026; the trial aims to enroll 1,770 participants[5][6]. - VYD2311 received Fast Track designation from the FDA in December 2025, which may expedite its development and review process[6]. - The Phase 1/2 study of VYD2311 showed it was well tolerated at four times the planned dose for the DECLARATION trial, with no serious adverse events reported[7]. - The company is preparing for the potential commercial launch of VYD2311, pending regulatory approval, which may deliver clinically meaningful titer levels[24]. Pipeline Expansion - The potential best-in-class RSV antibody candidate VBY329 has been nominated for preclinical development, targeting a blockbuster market expected to reach $3-$4 billion in annual revenues by 2030[12]. - Invivyd is expanding its pipeline to include a preclinical measles mAb candidate, with selection targeted for the first half of 2026[12]. - The company is expanding its pipeline beyond SARS-CoV-2, targeting potential candidates such as RSV and measles[24]. Strategic Focus and Market Considerations - The company believes it can drive substantial medical and shareholder value creation through its product candidates[24]. - The company is assessing the market size and opportunity for its product candidates, including the potential of PEMGARDA as a mAb for COVID-19 prevention[24]. - The company faces uncertainties regarding market acceptance and reimbursement for its authorized products[25]. - The company is reliant on third parties for certain aspects of its operations, including manufacturing mAb therapies[25]. - The company acknowledges risks related to the regulatory environment and the success of its clinical trials[25]. Safety and Efficacy - The company is focused on maintaining a continued acceptable safety, tolerability, and efficacy profile for its product candidates following regulatory authorization[25]. - The company is committed to delivering protection from serious viral infectious diseases, starting with SARS-CoV-2[24].