Adagio(IVVD) - 2023 Q4 - Annual Results

Business Highlights and Outlook Invivyd achieved PEMGARDA's EUA for COVID-19 PrEP in 2023 and is now focused on its U.S. commercial launch Overview Invivyd secured PEMGARDA's EUA for COVID-19 PrEP in 2023, now prioritizing its U.S. commercial launch - PEMGARDA received Emergency Use Authorization (EUA) for COVID-19 pre-exposure prophylaxis in specific immunocompromised individuals[3][4] - PEMGARDA is the first PrEP monoclonal antibody to receive EUA via rapid immunobridging and the first from the INVYMAB™ platform[3][5] - The company is executing its U.S. commercial launch plan with a targeted field sales organization focusing on key healthcare practitioners[3] Recent Program Highlights Recent achievements include PEMGARDA's EUA, VYD2311 nomination, and a $40.5 million stock sale strengthening the balance sheet - PEMGARDA received EUA from the U.S. FDA on March 22, 2024, for COVID-19 pre-exposure prophylaxis in specific immunocompromised populations[4] - VYD2311 was nominated as the next anti-SARS-CoV-2 mAb candidate, optimized for neutralization against variants like BA.2.86 and JN.1[6] - The balance sheet was strengthened by selling shares totaling $40.5 million in gross proceeds in February 2024, ahead of PEMGARDA's launch[5] Full Year 2023 Financial Results Invivyd reported a $198.6 million net loss for FY2023, an improvement from 2022, with $200.6 million cash expected to fund operations into Q4 2024 Financial Summary Invivyd reported a $198.6 million net loss for FY2023, an improvement from 2022, with $200.6 million in cash expected to fund operations into Q4 2024 Full Year 2023 Financial Highlights (in millions, except per share data) | Financial Metric | FY 2023 | FY 2022 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $163.6 | $183.6 | ($20.0) | | SG&A Expenses | $49.1 | $47.0 | $2.1 | | Net Loss | ($198.6) | ($241.3) | $42.7 | | Net Loss Per Share | ($1.81) | ($2.23) | $0.42 | | Cash & Cash Equivalents | $200.6 | $92.1 | $108.5 | - Cash and cash equivalents totaled $200.6 million as of December 31, 2023, expected to fund operations into Q4 2024, excluding PEMGARDA sales[9] - The decrease in R&D expenses was primarily due to lower personnel costs and adintrevimab trial wind-down, partially offset by PEMGARDA manufacturing and clinical costs[9] - The increase in SG&A expenses was primarily driven by higher personnel-related and commercial costs[9] Financial Statements Invivyd's 2023 financial statements show total assets decreased to $229.2 million and a net loss of $198.6 million Consolidated Balance Sheets As of December 31, 2023, total assets decreased to $229.2 million, liabilities increased to $51.7 million, and stockholders' equity decreased to $177.5 million Consolidated Balance Sheet Summary (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $200,641 | $92,076 | | Marketable securities | $0 | $279,915 | | Total current assets | $224,881 | $376,917 | | Total assets | $229,181 | $383,167 | | Liabilities & Equity | | | | Total current liabilities | $50,291 | $25,031 | | Total liabilities | $51,713 | $27,197 | | Total stockholders' equity | $177,468 | $355,970 | Consolidated Statements of Operations and Comprehensive Loss For FY2023, total operating expenses were $212.8 million, resulting in a net loss of $198.6 million, or $1.81 per share, an improvement from 2022 Consolidated Statement of Operations Summary (in thousands, except per share data) | Account | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development | $158,658 | $179,214 | | Selling, general and administrative | $49,125 | $47,044 | | Total operating expenses | $212,758 | $248,031 | | Loss from operations | ($212,758) | ($248,031) | | Other income, net | $14,115 | $6,714 | | Net loss | ($198,643) | ($241,317) | | Net loss per share, basic and diluted | ($1.81) | ($2.23) | Company and Product Information This section details PEMGARDA, an investigational monoclonal antibody for COVID-19 PrEP, and Invivyd's focus on antibody-based therapies About PEMGARDA PEMGARDA is an investigational half-life extended monoclonal antibody targeting SARS-CoV-2, with EUA based on immunobridging and in vitro activity against variants - PEMGARDA is a half-life extended investigational monoclonal antibody engineered from adintrevimab[8] - It demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, by targeting the spike protein RBD[8] - The EUA was supported by an immunobridging approach, which has limitations due to reliance on data from different populations and non-circulating variants[11] - PEMGARDA is not authorized for the treatment of COVID-19 or for post-exposure prophylaxis[10] About Invivyd Invivyd is a commercial-stage biopharmaceutical company focused on delivering antibody-based therapies for viral threats using its INVYMAB™ platform - Invivyd is a commercial-stage company focused on rapidly delivering antibody-based therapies for circulating viral threats[13] - The proprietary INVYMAB™ platform facilitates rapid, serial generation of new monoclonal antibodies to keep pace with evolving viruses[13] Important Safety Information for PEMGARDA This section details critical safety information for PEMGARDA, including a boxed warning for anaphylaxis, contraindications, and common adverse reactions Boxed Warning: Anaphylaxis PEMGARDA carries a boxed warning for anaphylaxis, observed in 0.6% of participants, requiring administration in settings with immediate access to treatment and post-infusion monitoring - Anaphylaxis, observed in 0.6% (4/623) of clinical trial participants, can be life-threatening with PEMGARDA[22] - PEMGARDA must be administered in settings with immediate access to anaphylaxis treatment medications[22] - Patients require clinical monitoring during infusion and for at least two hours post-completion[22] Contraindications, Warnings, and Precautions PEMGARDA is contraindicated for prior severe hypersensitivity, with warnings for serious hypersensitivity, cross-hypersensitivity with COVID-19 vaccines, and potential ineffectiveness against emerging variants - Contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any PEMGARDA component[23] - Risk of cross-hypersensitivity with COVID-19 vaccines exists due to PEMGARDA containing polysorbate 80, similar to PEG in some vaccines[25] - Emerging SARS-CoV-2 viral variants may not be neutralized by PEMGARDA, rendering it ineffective against those strains[26] Adverse Reactions and Use in Specific Populations Common adverse events (≥2%) include infusion reactions, respiratory infection, fatigue, headache, and nausea; data is insufficient for pregnancy/lactation, and it is not authorized for children under 12 or 40 kg - Most common adverse events (incidence ≥2%) include systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea[27] - Insufficient data exists to evaluate risks associated with use during pregnancy or lactation[28][29] - PEMGARDA is not authorized for use in children under 12 years of age or weighing less than 40 kg[30] Emergency Use Authorization (EUA) Details PEMGARDA's EUA is for COVID-19 pre-exposure prophylaxis in specific immunocompromised adults and adolescents, not for treatment or post-exposure, and requires mandatory adverse event reporting - Authorized for COVID-19 pre-exposure prophylaxis in adults and adolescents (≥12 years, ≥40 kg) with moderate-to-severe immune compromise unlikely to mount an adequate vaccine response[31][35] - PEMGARDA is not authorized for COVID-19 treatment or post-exposure prophylaxis[35] - Healthcare providers are responsible for mandatory reporting of all serious adverse events and medication errors to the FDA MedWatch program[36][37] Forward-Looking Statements This section contains forward-looking statements about PEMGARDA's potential, commercialization, and financial outlook, subject to significant risks and uncertainties detailed in SEC filings Cautionary Note Regarding Forward-Looking Statements This section contains forward-looking statements about PEMGARDA's potential, commercialization, and financial outlook, subject to significant risks and uncertainties detailed in SEC filings - The press release includes forward-looking statements regarding PEMGARDA's potential, commercialization, INVYMAB platform, R&D, and cash runway[14] - These statements involve risks and uncertainties, including EUA duration, commercialization success, regulatory changes, manufacturing complexities, and market competition[14][15] - Investors are advised against undue reliance on these statements and directed to the 'Risk Factors' section in SEC filings for potential risks[15]