Adagio(IVVD) - 2024 Q1 - Quarterly Results

Introduction and Company Overview Invivyd, Inc. is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases, with PEMGARDA as its first commercial product - Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases[2] - The company is currently executing on the commercial launch of PEMGARDA, its first monoclonal antibody (mAb) product[3] Recent Business and Pipeline Highlights Invivyd launched PEMGARDA commercially, reported positive clinical data for VYD222, and advanced VYD2311 as its next mAb candidate PEMGARDA Commercialization & Reimbursement Invivyd successfully launched PEMGARDA in the U.S. after EUA for COVID-19 PrEP, securing CMS reimbursement codes for the target population - PEMGARDA (pemivibart) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on March 22, 2024, for COVID-19 pre-exposure prophylaxis (PrEP) in immunocompromised individuals[4][5] - PEMGARDA was launched in the U.S. and became available for purchase through authorized specialty distributors at the beginning of April, with market access and sales teams fully operational by the end of April[4][5][6] - The U.S. Centers for Medicare & Medicaid Services (CMS) granted product-specific reimbursement codes (HCPCS Q code Q0224 and M code M0224) for PEMGARDA in April 2024, covering an estimated half of the target immunocompromised population[5][9] Clinical Development & Pipeline Advancement Invivyd reported positive VYD222 Phase 3 data, plans a rapid EUA for PEMGARDA treatment, and is advancing VYD2311 for new variants - Interim exploratory COVID-19 clinical event data from the CANOPY Phase 3 clinical trial of VYD222 were reported in March 2024, reflecting a potential signal of clinical protection from symptomatic COVID-19[5][9] - Invivyd plans to imminently submit an EUA application to the FDA for pemivibart for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people, utilizing a rapid immunobridging pathway aligned with FDA feedback[5][9] - VYD2311 is expected to be the next anti-SARS-CoV-2 mAb candidate to advance into clinical development, optimized for neutralization potency against recent lineages like BA.2.86 and JN.1 using Invivyd's state-of-the-art technologies[5][9] First Quarter 2024 Financial Results Invivyd reported its Q1 2024 financial results, including cash position, operating expenses, and net loss, reflecting PEMGARDA launch activities Cash Position and Outlook Invivyd ended Q1 2024 with $189.4 million in cash, projecting at least $75 million by year-end based on PEMGARDA revenue Cash and Cash Equivalents | Metric | March 31, 2024 (in millions) | December 31, 2023 (in millions) | | :----- | :--------------------------- | :------------------------------ | | Cash and cash equivalents | $189.4 | $200.6 | - Invivyd expects to end 2024 with at least $75 million in cash and cash equivalents, based on anticipated 2024 net product revenue of $150 million to $200 million and recent resource realignment[5][12] Operating Expenses R&D and SG&A expenses increased in Q1 2024, driven by PEMGARDA commercial manufacturing, clinical trials, and launch-related personnel costs Operating Expenses (Q1 2024 vs. Q1 2023) | Expense Category | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change (YoY, in thousands) | Primary Driver | | :--------------- | :--------------------- | :--------------------- | :------------------------- | :------------- | | Research & Development | $31,160 | $27,201 | +$3,959 | Commercial manufacturing of PEMGARDA, CANOPY Phase 3 clinical trial monitoring | | Selling, General & Administrative | $14,929 | $11,045 | +$3,884 | Personnel-related costs, commercial costs for PEMGARDA launch | Net Loss and Net Loss per Share Invivyd reported an increased net loss of $43.5 million and a net loss per share of $0.38 for Q1 2024 compared to the prior year Net Loss and EPS (Q1 2024 vs. Q1 2023) | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net Loss (in millions) | $(43.5) | $(35.3) | $(8.2) | | Net Loss per Share (Basic & Diluted) | $(0.38) | $(0.32) | $(0.06) | Condensed Consolidated Balance Sheets Invivyd's total assets were $215.5 million as of March 31, 2024, with a decrease in cash and current liabilities from year-end 2023 Key Balance Sheet Data (March 31, 2024 vs. December 31, 2023) | Metric (in thousands) | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :-------------------- | :---------------------------- | :------------------------------- | | Total Assets | $215,468 | $229,181 | | Total Liabilities | $36,970 | $51,713 | | Total Stockholders' Equity | $178,498 | $177,468 | | Cash and cash equivalents | $189,388 | $200,641 | | Total current assets | $209,883 | $224,881 | | Total current liabilities | $36,345 | $50,291 | Condensed Consolidated Statements of Operations and Comprehensive Loss Invivyd reported total operating expenses of $46.1 million and a net loss of $43.5 million for Q1 2024 Key Income Statement Data (Three Months Ended March 31, 2024 vs. 2023) | Metric (in thousands) | March 31, 2024 (in thousands) | March 31, 2023 (in thousands) | | :-------------------- | :---------------------------- | :---------------------------- | | Total operating expenses | $46,089 | $39,071 | | Loss from operations | $(46,089) | $(39,071) | | Other income, net | $2,593 | $3,750 | | Net loss | $(43,496) | $(35,321) | | Comprehensive loss | $(43,495) | $(35,164) | About PEMGARDA This section details PEMGARDA's product description, authorized use, safety information, and the immunobridging approach supporting its EUA Product Description and Mechanism PEMGARDA is a half-life extended investigational mAb targeting the SARS-CoV-2 spike protein RBD, demonstrating in vitro neutralizing activity against variants like JN.1 - PEMGARDA (pemivibart) is a half-life extended investigational monoclonal antibody (mAb) engineered from adintrevimab[11] - It targets the SARS-CoV-2 spike protein receptor binding domain (RBD), inhibiting virus attachment to human ACE2 receptors, and has demonstrated in vitro neutralizing activity against major variants, including JN.1[11] Authorized Use and Safety Information PEMGARDA is authorized under EUA for COVID-19 pre-exposure prophylaxis in specific immunocompromised individuals, with a boxed warning for anaphylaxis - PEMGARDA is authorized for emergency use for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years and older weighing at least 40 kg) with moderate-to-severe immune compromise[12][13] - It is not authorized for use for the treatment of COVID-19 or post-exposure prophylaxis of COVID-19[13] - Anaphylaxis has been observed with PEMGARDA, and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis[13] Immunobridging Approach and Data Limitations PEMGARDA's EUA relies on an immunobridging approach, with data limitations including reliance on older variant efficacy and variability in EC50 determinations - The EUA for PEMGARDA was supported by an immunobridging approach, which determines effectiveness based on serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2[14] - Limitations of the data include that evidence of clinical efficacy for other mAbs was based on different populations and SARS-CoV-2 variants no longer circulating, and variability in cell-based EC50 value determinations[14] - The emergency use authorization for PEMGARDA is only valid for the duration of the COVID-19 pandemic declaration, unless terminated or revoked sooner[15] About Invivyd Invivyd is a biopharmaceutical company focused on viral infectious diseases, leveraging its INVYMAB™ platform to develop new monoclonal antibodies against evolving threats - Invivyd, Inc. is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2[16] - The company's proprietary INVYMAB™ platform combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to address evolving viral threats[16] - PEMGARDA is Invivyd's first mAb authorized under EUA, representing the initial product in a planned series of innovative antibody candidates[16] Cautionary Note Regarding Forward-Looking Statements This section warns that forward-looking statements are subject to risks and uncertainties, and Invivyd disclaims any obligation to update them - The press release contains forward-looking statements, identified by terms like 'anticipates,' 'expects,' and 'potential,' covering topics such as PEMGARDA commercialization, pipeline development, and financial projections[17] - These statements involve risks and uncertainties, including regulatory changes, competition, manufacturing complexities, and funding adequacy, which could cause actual results to differ materially[17][18] - Invivyd undertakes no duty to update such information, except as required by applicable law, and advises readers to consult the company's SEC filings for a comprehensive list of risk factors[18] Additional Information This section provides details on the conference call and webcast for Q1 2024 financial results, along with contact information Conference Call & Webcast Invivyd hosted a conference call and webcast on May 9, 2024, to discuss Q1 2024 results, with a replay available on its investor website - Invivyd management hosted a conference call and webcast on May 9, 2024, at 4:30 PM ET to provide a quarterly update[5][10] - A replay of the webcast is available via the company's investor website approximately two hours after the call's conclusion[10] Contacts Contact information for media and investor relations is provided for inquiries - Media Relations and Investor Relations can be contacted at (781) 208-0160 or via email at media@invivyd.com and investors@invivyd.com, respectively[20]