Adagio(US:IVVD)2025-08-14 21:00PART I Item 1. Financial Statements (Unaudited) This section presents Invivyd, Inc.'s unaudited condensed consolidated financial statements as of June 30, 2025, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with notes, reflecting increased product revenue but continued net losses and a "going concern" warning Condensed Consolidated Balance Sheets The balance sheet as of June 30, 2025, shows total assets decreased to $89.1 million from $129.5 million at year-end 2024, primarily due to reduced cash and cash equivalents, with total stockholders' equity also declining to $42.8 million from $67.5 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $34,905 | $69,349 | | Total current assets | $59,281 | $100,681 | | Total assets | $89,138 | $129,515 | | Liabilities & Stockholders' Equity | | | | Total current liabilities | $44,451 | $61,976 | | Total liabilities | $46,349 | $61,976 | | Total stockholders' equity | $42,789 | $67,539 | | Total liabilities and stockholders' equity | $89,138 | $129,515 | Condensed Consolidated Statements of Operations and Comprehensive Loss For the three and six months ended June 30, 2025, the company reported significant year-over-year revenue growth from PEMGARDA, while net losses narrowed considerably due to lower research and development and SG&A expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $11,786 | $2,264 | $23,090 | $2,264 | | Research and development | $9,573 | $30,334 | $20,214 | $61,494 | | Selling, general and administrative | $16,588 | $21,089 | $33,339 | $36,018 | | Loss from operations | ($15,060) | ($49,247) | ($31,982) | ($95,336) | | Net loss | ($14,660) | ($47,247) | ($30,949) | ($90,743) | | Net loss per share | ($0.12) | ($0.40) | ($0.26) | ($0.77) | Condensed Consolidated Statements of Stockholders' Equity Total stockholders' equity decreased from $67.5 million at the end of 2024 to $42.8 million as of June 30, 2025, primarily due to the $30.9 million net loss for the six-month period, partially offset by stock-based compensation and stock option exercises - Total stockholders' equity decreased from $67.5 million on December 31, 2024, to $42.8 million on June 30, 2025, mainly due to the accumulated deficit increasing from $902.0 million to $932.9 million19 Condensed Consolidated Statements of Cash Flows For the six months ended June 30, 2025, the company used $34.4 million in cash from operating activities, resulting in a net decrease in cash and cash equivalents of $34.4 million and an ending cash balance of $34.9 million Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($34,430) | ($91,813) | | Net cash used in investing activities | ($155) | ($140) | | Net cash provided by financing activities | $141 | $39,193 | | Net decrease in cash and cash equivalents | ($34,444) | ($52,760) | | Cash and cash equivalents at end of period | $34,905 | $147,881 | Notes to Unaudited Condensed Consolidated Financial Statements The notes provide critical details on accounting policies and specific financial items, including the Emergency Use Authorization for PEMGARDA, progress on VYD2311, and a significant disclosure of substantial doubt about the company's ability to continue as a going concern - The company's first monoclonal antibody, PEMGARDA®, received Emergency Use Authorization (EUA) from the FDA on March 22, 2024, for the pre-exposure prophylaxis of COVID-19 in certain immunocompromised individuals2728 - The company has concluded that there is substantial doubt about its ability to continue as a going concern, as current cash and cash equivalents are not sufficient to fund operating expenses and capital requirements beyond one year from the financial statement issuance date38 - As of June 30, 2025, the company had noncancelable purchase obligations of $29.4 million due to its manufacturing partner WuXi Biologics, expected to be paid in 2025103104 - On April 18, 2025, the company entered into a Loan and Security Agreement for a senior secured term loan facility of up to $30 million, contingent on meeting certain financial and revenue milestones, with no funds drawn as of June 30, 2025110 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial performance, liquidity, and business outlook, highlighting PEMGARDA's commercialization and VYD2311's development, while reiterating substantial doubt about its going concern ability and the need for additional funding Results of Operations This section details the comparison of operating results for the three and six months ended June 30, 2025 and 2024, showing net product revenue increased to $11.8 million from $2.3 million in Q2 2025, and net loss narrowed to $14.7 million from $47.2 million, primarily due to a $20.8 million decrease in R&D expenses Comparison of Results for the Six Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Product revenue, net | $23,090 | $2,264 | $20,826 | | Research and development | $20,214 | $61,494 | ($41,280) | | Selling, general and administrative | $33,339 | $36,018 | ($2,679) | | Loss from operations | ($31,982) | ($95,336) | $63,354 | | Net loss | ($30,949) | ($90,743) | $59,794 | - The decrease in R&D expenses for the first six months of 2025 was primarily driven by reduced contract costs for commercial manufacturing and clinical trials for both the pemivibart and VYD2311 programs209 - The company noted that if pre-EUA manufacturing costs had been capitalized instead of expensed as R&D, its reported product margins would approach 80%196204 Liquidity and Capital Resources The company's liquidity position is critical, with cash and cash equivalents at $34.9 million as of June 30, 2025, which management explicitly states is insufficient to support operations for the next year, leading to substantial doubt about its ability to continue as a going concern without additional funding - As of June 30, 2025, the company had cash and cash equivalents of $34.9 million213 - The company concludes there is substantial doubt about its ability to continue as a going concern, as it will not have sufficient cash to fund operations beyond one year without additional financing or revenue contributions173224 - In February 2024, the company raised $39.3 million in net proceeds by selling 9 million shares through its "at the market" (ATM) sales agreement, with $34.5 million remaining available for sale as of June 30, 2025214 Quantitative and Qualitative Disclosures About Market Risk The company is a smaller reporting company and is therefore not required to provide the information for this item - As a smaller reporting company, Invivyd is not required to provide quantitative and qualitative disclosures about market risk234 Controls and Procedures Management, including the Chief Financial Officer, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of June 30, 2025, with no material changes to internal control over financial reporting identified during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025236 - There were no material changes in the company's internal control over financial reporting during the quarter ended June 30, 2025237 PART II. OTHER INFORMATION Legal Proceedings As of June 30, 2025, the company reports that it was not a party to any material legal proceedings - The company was not a party to any material legal proceedings as of June 30, 2025240 Risk Factors This section updates the company's risk factors, highlighting the risk of being delisted from the Nasdaq Global Market for failing to meet the minimum $1.00 bid price requirement and risks associated with the new Loan and Security Agreement, including restrictive covenants, default conditions, and the uncertainty of being able to draw down funds if milestones are not met - The company is at risk of being delisted from Nasdaq, having received a non-compliance notice on April 21, 2025, for its stock price closing below $1.00 for 30 consecutive days, and has until October 20, 2025, to regain compliance244 - The new Loan Agreement contains covenants that limit the company's operational flexibility, and a default could lead to acceleration of debt repayment and foreclosure on assets247259 - Access to the tranches of the $30 million term loan facility is contingent on achieving certain net product revenue milestones, which had not been satisfied as of June 30, 2025257 Unregistered Sales of Equity Securities and Use of Proceeds The company reports that it did not issue any unregistered equity securities during the three months ended June 30, 2025 - No unregistered equity securities were sold during the second quarter of 2025261 Other Information During the second quarter of 2025, none of the company's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the three months ended June 30, 2025265 Exhibits This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, the new loan agreement, and officer certifications