Omeros(US:OMER)2025-05-15 20:32Part I — Financial Information Financial Statements (unaudited) The company reported a reduced net loss for Q1 2025 but faces a going concern warning due to recurring losses and upcoming debt maturities Condensed Consolidated Statements of Operations (Q1 2025 vs Q1 2024) | Metric | Q1 2025 (In thousands) | Q1 2024 (In thousands) | | :--- | :--- | :--- | | Total costs and expenses | $34,969 | $39,034 | | Research and development | $23,846 | $26,770 | | Selling, general and administrative | $11,123 | $12,264 | | Loss from operations | $(34,969) | $(39,034) | | Interest expense | $(3,654) | $(8,231) | | Interest and other income | $1,058 | $3,415 | | Net loss from continuing operations | $(37,565) | $(43,850) | | Net income from discontinued operations | $4,105 | $6,666 | | Net loss | $(33,460) | $(37,184) | | Net loss per share (basic and diluted) | $(0.58) | $(0.63) | Condensed Consolidated Balance Sheet Highlights (As of March 31, 2025) | Account | March 31, 2025 (In thousands) | December 31, 2024 (In thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $4,261 | $3,400 | | Short-term investments | $48,150 | $86,732 | | Total current assets | $96,181 | $134,120 | | Total assets | $235,161 | $277,079 | | Total current liabilities | $83,222 | $79,526 | | Total liabilities | $448,714 | $459,688 | | Total shareholders' deficit | $(213,553) | $(182,609) | Condensed Consolidated Statements of Cash Flows (Q1 2025 vs Q1 2024) | Activity | Q1 2025 (In thousands) | Q1 2024 (In thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(35,841) | $(41,780) | | Net cash provided by (used in) investing activities | $38,541 | $(61,925) | | Net cash (used in) provided by financing activities | $(1,839) | $98,431 | | Net increase (decrease) in cash | $861 | $(5,274) | - The company's recurring losses and cash balance, combined with the 2026 Notes maturity, raise substantial doubt about its ability to continue as a going concern44 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses clinical pipeline updates, reduced operating expenses, and significant liquidity challenges including a going concern warning - The BLA for narsoplimab in TA-TMA was resubmitted to the FDA and has been assigned a PDUFA target action date of September 25, 202529132 - The company has temporarily paused its Phase 3 clinical development program for zaltenibart in PNH to prioritize available capital32137 - In May 2025, the company restructured its debt, reducing the 2026 Notes principal from $97.9 million to $27.1 million and alleviating a potential $20.0 million prepayment on its Term Loan157158 - The company's recurring losses and cash position raise substantial doubt about its ability to continue as a going concern, necessitating the need to raise additional capital179180 Results of Operations Total costs and expenses decreased year-over-year, driven by lower R&D, SG&A, and interest expenses Research and Development Expenses (Q1 2025 vs Q1 2024) | Category (In thousands) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | MASP-3 program - OMS906 (zaltenibart) | $7,030 | $5,253 | | MASP-2 program - OMS721 (narsoplimab) | $2,631 | $6,685 | | MASP-2 program - OMS1029 and other | $364 | $1,126 | | Preclinical research and development | $1,383 | $1,580 | | Internal overhead and other expenses | $11,402 | $11,112 | | Stock-based compensation expenses | $1,036 | $1,014 | | Total R&D Expenses | $23,846 | $26,770 | - R&D expenses are expected to be lower in Q2 2025 compared to Q1 2025 due to the pause in two Phase 3 clinical trials for zaltenibart and other program reductions163 Selling, General and Administrative Expenses (Q1 2025 vs Q1 2024) | Category (In thousands) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | SG&A (excluding stock-based comp) | $9,706 | $10,620 | | Stock-based compensation | $1,417 | $1,644 | | Total SG&A Expenses | $11,123 | $12,264 | - Interest expense decreased by $4.6 million YoY, mainly due to a favorable non-cash remeasurement adjustment on the OMIDRIA royalty obligation and lower interest on repurchased 2026 Notes171 Financial Condition – Liquidity and Capital Resources The company holds $52.4 million in cash and investments but faces substantial going concern doubt, exploring capital raising options - As of March 31, 2025, the company had $52.4 million in cash, cash equivalents, and short-term investments178 - A credit agreement covenant requires the company to maintain $25.0 million of unrestricted cash, cash equivalents, and short-term investments at all times178 - The company has an at-the-market (ATM) equity offering facility for up to $150.0 million and raised $3.5 million in net proceeds after quarter-end182 - The company has taken steps to manage expenses by delaying clinical trials and reducing selected R&D efforts, with further reductions possible if necessary183 Quantitative and Qualitative Disclosures About Market Risk The company's market risk is primarily limited to its high-credit-quality, short-term investment securities portfolio - The company's primary market risk exposure is from its investment securities, which consist of high-credit-quality securities like money market funds195 - Due to the short-term maturities of its investments, the company does not believe an increase in market rates would materially impact the realized value of its investment portfolio195 Controls and Procedures Management concluded that disclosure controls and procedures were effective as of the quarter-end with no material changes to internal controls - As of March 31, 2025, the principal executive and financial officers concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level196 - No material changes in internal control over financial reporting occurred during the quarter that are reasonably likely to materially affect these controls197 Part II — Other Information Legal Proceedings The company was not involved in any material legal proceedings as of the filing date - The company was not involved in any material legal proceedings as of the date of the 10-Q filing199 Risk Factors Investors are referred to the company's 2024 Form 10-K for a detailed discussion of significant business risks and uncertainties - The report refers to the risk factors described in the company's Annual Report on Form 10-K for the year ended December 31, 2024, for a comprehensive understanding of potential risks200 Unregistered Sales of Equity Securities and Use of Proceeds This item is not applicable for the reporting period - Not applicable201 Other Information No directors or Section 16 officers adopted or terminated Rule 10b5-1 trading plans during the first quarter of 2025 - No directors or Section 16 reporting officers adopted or terminated any Rule 10b5-1 trading plans during the three months ended March 31, 2025204 Exhibits This section lists the exhibits filed with the report, including required officer certifications and Inline XBRL data - The report includes certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act of 2002205