Invivyd (IVVD) Q1 2025 Earnings Call May 15, 2025 08:30 AM ET Speaker0 Thank you for standing by, and welcome to Nvivit's First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. To remove yourself from the queue, you may press 11 again. I would now like to hand the call over to Katie Bozzon ...

Invivyd, Inc. (IVVD) came out with a quarterly loss of $0.14 per share versus the Zacks Consensus Estimate of a loss of $0.04. This compares to loss of $0.38 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -250%. A quarter ago, it was expected that this company would post a loss of $0.25 per share when it actually produced a loss of $0.15, delivering a surprise of 40%.Over the last four quarters, the company has surpassed cons ...

Regulatory Approvals - Invivyd, Inc. received emergency use authorization (EUA) from the FDA for PEMGARDA on March 22, 2024, for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents [156]. - The company received Emergency Use Authorization (EUA) from the FDA for PEMGARDA on March 22, 2024 [181]. Financial Performance - The company reported a net loss of $16.3 million for the three months ended March 31, 2025, with an accumulated deficit of $918.3 million as of the same date [165]. - Product revenue, net was $11.3 million for the three months ended March 31, 2025, compared to $0 for the same period in 2024, reflecting sales from the launch of PEMGARDA [191]. - The company reported a net loss of $16.3 million for the three months ended March 31, 2025, a decrease from a net loss of $43.5 million in the same period of 2024 [206][207]. - Other income decreased to $0.6 million for the three months ended March 31, 2025, from $2.6 million in 2024, primarily due to interest earned on invested cash balances [197]. - The company incurred a net cash used in operating activities of $21.1 million for the three months ended March 31, 2025, compared to $50.2 million for the same period in 2024, indicating a 58.1% improvement [205][207]. - The company reported a net decrease in cash and cash equivalents of $21.3 million for the three months ended March 31, 2025, compared to a decrease of $11.3 million in the same period of 2024 [205]. Research and Development - The ongoing Phase 1 clinical trial of VYD2311 is evaluating safety, tolerability, pharmacokinetics, and immunogenicity, with positive clinical data reported for both safety and pharmacokinetics [157]. - The company aims to develop monoclonal antibodies (mAbs) for serious viral diseases, starting with COVID-19 and potentially expanding into other high-need indications [158]. - The company expects research and development expenses to increase as it advances VYD2311 through clinical development and seeks regulatory approval for its product candidates [177]. - Research and development expenses decreased by $20.5 million to $10.6 million for the three months ended March 31, 2025, from $31.2 million in 2024 [196]. - Acquired in-process research and development expenses consist primarily of costs related to acquiring rights to Adimab's antibodies for COVID-19 and SARS [182]. Commercialization and Expenses - Invivyd, Inc. has incurred significant commercialization expenses related to product manufacturing, marketing, sales, and distribution of PEMGARDA [166]. - The company anticipates ongoing expenses related to the commercialization of PEMGARDA and the development of other product candidates, which may lead to continued operating losses [198]. - Selling, general and administrative expenses increased by $1.8 million to $16.8 million for the three months ended March 31, 2025, compared to $14.9 million in 2024 [196]. - Cost of product revenue was $0.8 million for the three months ended March 31, 2025, with no cost recorded for the same period in 2024 [192]. - The company has committed to noncancelable purchase obligations of $27.4 million related to commercial drug substance and drug product manufacturing, expected to be paid in 2025 [214]. Funding and Liquidity - Invivyd, Inc. has financed operations primarily with net proceeds of $464.7 million from preferred stock sales and $327.5 million from its IPO [164]. - The company expects to require additional funding to support ongoing operations and growth strategy, with substantial doubt about its ability to continue as a going concern without securing additional funds [169]. - The company entered into a Loan Agreement providing for a senior secured term loan facility of up to $30 million, with terms including a repayment period starting March 1, 2029 [203][204]. - The company raised $39.3 million from the sale of 9,000,000 shares of common stock at an average price of $4.50 per share under a Sales Agreement in February 2024 [202]. - The company expects to finance operations through a combination of revenue contributions, equity offerings, and debt financing, indicating a focus on maintaining liquidity [213]. - The company has substantial doubt about its ability to continue as a going concern, as it may not have sufficient cash to fund operations beyond one year from the issuance of its financial statements [212]. Inventory and Manufacturing - The company has capitalized inventory costs since March 2024, which would have resulted in reported margins approaching 80% if pre-EUA manufacturing costs had been capitalized [193]. - The company is actively monitoring SARS-CoV-2 variants and reported continued neutralizing activity of PEMGARDA against variants KP.3.1.1 and LB.1 [161]. - The company has initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including potential targets such as respiratory syncytial virus and measles [162]. Accounting and Compliance - The JOBS Act allows emerging growth companies to delay the adoption of new accounting standards until they apply to private companies [220]. - Companies are exempt from compliance with the auditor attestation requirement for internal control over financial reporting [221]. - Reduced disclosure obligations regarding executive compensation are available for smaller reporting companies [221]. - Exemptions from non-binding advisory votes on executive compensation and stockholder approval of golden parachute payments are provided [221]. - Companies are not required to disclose quantitative and qualitative information about market risk as they qualify as smaller reporting companies [222].

INVIVYD Q1 2025 FINANCIAL RESULTS & BUSINESS HIGHLIGHTS May 15, 2025 © 2025 Invivyd, Inc. Invivyd , Pemgarda , and the Ribbon logos are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are ...

Exhibit 99.1 Invivyd Reports First Quarter 2025 Financial Results and Recent Business Highlights WALTHAM, Mass., May 15, 2025 – Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the quarter ended March 31, 2025, and provided recent business highlights. "To drive long-term topline growth, we made a strategic decision to internalize our sales force at the beginning of 2025," said Bill Duke, Chief Financial Officer of Invivyd. "Although this shift created a short-term headwind, we're now seein ...

PEMGARDA™ (pemivibart) net product revenue of $11.3 million reported for Q1 2025, influenced by planned transition (Jan/Feb) from a contracted to an internalized sales forcePEMGARDA revenue re-acceleration observed in Q2 2025 to dateInvivyd continues to target near-term profitability (1H 2025) with existing cash and cash equivalents, anticipated growth of net product revenue, and continued reduction of operating expensesSince Emergency Use Authorization (EUA) of PEMGARDA in March 2024, no documented cases o ...

Core Viewpoint - Invivyd, Inc. has initiated a discovery program for a measles monoclonal antibody (mAb) in response to inquiries from healthcare providers, as there are currently no approved therapies for measles or post-exposure prophylaxis [1][6] Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases, utilizing a proprietary integrated technology platform for developing best-in-class antibodies [7] Industry Context - There are no antiviral treatments for measles, with current options being limited to high-dose Vitamin A and human donor-derived pooled plasma immune globulin (IVIG), both of which have significant limitations [2] - Standard measles vaccines are effective but face challenges in post-exposure prophylaxis and are underutilized due to access issues and personal beliefs [3] - The resurgence of measles outbreaks globally, including in the U.S., poses a significant public health risk, with over 20 million unvaccinated Americans [5][6] Health Implications - Acute measles infection can lead to severe complications, including hospitalization in one in four cases and death in one in every 1,000 cases [4] - The decline in vaccination rates has serious health consequences, potentially leading to the reestablishment of previously eradicated pathogens like measles [3][5] Development Goals - Invivyd aims to identify a preclinical measles mAb candidate by 2025 and plans to provide updates on progress by the end of the year [6] - The company is focused on developing a safe, convenient, and highly effective mAb against measles that can be easily integrated into clinical practice [7]

WALTHAM, Mass., May 08, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Thursday, May 15, 2025, at 8:30 a.m. ET to discuss its financial results for the first quarter ended March 31, 2025, and provide recent business highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session ...

Core Viewpoint - Invivyd, Inc. has secured a $30 million term loan facility with Silicon Valley Bank to support its development pipeline, particularly focusing on the monoclonal antibody candidate VYD2311 for COVID-19 [1][2] Group 1: Financial Developments - The $30 million term loan facility allows for future capital drawdown contingent on meeting specific conditions and milestones [1] - The financing is non-dilutive, providing balance sheet flexibility for the company to concentrate on enhancing per-share value [2] Group 2: Product Development - VYD2311 is a novel monoclonal antibody candidate aimed at addressing the urgent need for new COVID-19 prophylactic and therapeutic options [2] - The candidate is designed to deliver clinically meaningful titer levels through a more patient-friendly intramuscular administration route [2] - VYD2311 utilizes Invivyd's proprietary technology platform and is optimized for neutralizing contemporary virus lineages [3] Group 3: Related Products - PEMGARDA (pemivibart) is another investigational monoclonal antibody developed from adintrevimab, showing in vitro neutralizing activity against major SARS-CoV-2 variants [4][5] - PEMGARDA has received emergency use authorization for pre-exposure prophylaxis in certain immunocompromised patients [5][6] - The product is not authorized for treatment or post-exposure prophylaxis of COVID-19 and should not replace vaccination [6][10] Group 4: Regulatory Context - The emergency use of PEMGARDA is authorized only during the COVID-19 pandemic under specific conditions, including variant susceptibility [10] - The company has received emergency use authorization from the U.S. FDA for a monoclonal antibody in its pipeline [11]

WALTHAM, Mass., March 26, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) is pleased to announce the appointment of Ajay Royan to its Board of Directors. Mr. Royan is a venture capitalist focused on transformational companies that have solved critical problems in healthcare, technology, and energy. Mr. Royan’s investment firm, Mithril, is a significant long-term holder of Invivyd stock, and Mr. Royan led the 2022 shareholder action that focused Invivyd on its mission to deliver protection from serious ...