Omeros Corp (OMER) Q2 2025 Earnings Call August 14, 2025 04:30 PM ET Speaker0Good afternoon and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in a listen only mode. After the company's remarks, we will conduct a question and answer session. Please be advised this call is being recorded at the company's request, and the replay will be available on the company's website one week from today. I will now turn the call over to Jennifer Williams, Investor Relations for ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 Washington 91-1663741 (State or other jurisdiction of incorporation or organization) or 201 Elliott Avenue West Seattle, Washington 98119 (Address of principal executive offices) (Zip Code) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHAN ...

Exhibit 99.1 Omeros Corporation Reports Second Quarter 2025 Financial Results – Conference Call Today at 4:30 p.m. ET SEATTLE, WA – August 14, 2025 – Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2025, which include: ● Net loss for the second quarter of 2025 was $25.4 million, or $0.43 per share, compared to a net loss of $56.0 million, or $0.97 per share for the second quarter of 2024. For the six mont ...

Group 1 - Omeros (OMER) has experienced a significant decline of 54.8% over the past four weeks, but it is now in oversold territory, indicating a potential trend reversal [1] - The Relative Strength Index (RSI) for OMER is currently at 24.55, suggesting that the heavy selling pressure may be exhausting, which could lead to a price rebound [5] - There is strong consensus among Wall Street analysts that OMER will report better earnings than previously predicted, with a 6.9% increase in the consensus EPS estimate over the last 30 days [7] Group 2 - OMER holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a turnaround [8]

Group 1 - The article discusses the author's first treatment of Omeros in 2025, following extensive coverage in the previous year [1] - The author emphasizes the learning process involved in investing, viewing failures as tuition and successes as lessons learned, particularly in the healthcare sector [2] - The author has a beneficial long position in Omeros shares, indicating a personal investment interest [3] Group 2 - The author may engage in buying or selling shares of any mentioned company within the next 72 hours, suggesting potential volatility or changes in position [4] - Seeking Alpha clarifies that past performance does not guarantee future results and that no specific investment advice is being provided [5]

Group 1 - Omeros Corporation held its Q1 2025 earnings conference call on May 15, 2025, at 4:30 PM ET [1] - The call included participants from the company such as the Chairman & CEO, Chief Accounting Officer, and Chief Commercial Officer [1][6] - The call was recorded and a replay will be available on the company's website for one week [1] Group 2 - Jennifer Williams, representing Investor Relations, opened the call and thanked participants for joining [2][3] - Forward-looking statements were mentioned, indicating that they are based on management's beliefs and expectations and are subject to change [4] - The call was turned over to Dr. Gregory Demopulos, the Chairman and CEO, who was joined by other key executives [5][6]

Financial Data and Key Metrics Changes - The company reported a net loss of $33.5 million or $0.58 per share for the first quarter of 2025, compared to a net loss of $31.4 million or $0.54 per share in the fourth quarter of the previous year [5][18] - As of March 31, 2025, the company had $52.4 million in cash and investments on hand [18] - The company entered into an exchange agreement to convert approximately $71 million of 2026 convertible notes into new 9.5% convertible senior notes due in 2029, significantly improving financial flexibility [5][19] Business Line Data and Key Metrics Changes - Research and development expenses in the first quarter were primarily focused on narsoplimab and zaltanibart [20] - OMIDRIA royalties for the first quarter totaled $6.7 million based on net sales of $22.3 million, a decrease from $10.1 million in royalties on net sales of $33.6 million in the previous quarter [22][23] Market Data and Key Metrics Changes - The market opportunity for narsoplimab is estimated at nearly $1 billion annually, with expectations for it to become a cornerstone asset for transplant experts [11] - The global market for paroxysmal nocturnal hemoglobinuria (PNH) is projected to grow to over $10 billion by 2032, with significant unmet needs in the complement inhibitor market [12] Company Strategy and Development Direction - The company is focused on the anticipated approval and launch of narsoplimab for the treatment of TATMA, with a target FDA action date of September 25 [8] - The company is also developing zaltanibart for PNH, with ongoing clinical trials and a temporary pause on the phase three program due to capital considerations [12][14] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of managing costs and maintaining liquidity while advancing key initiatives [7] - The company is actively pursuing partnerships for non-dilutive funding to support operations and the launch of narsoplimab [6] Other Important Information - The FDA has accepted the resubmitted BLA for narsoplimab, and the company is preparing for a successful launch [8] - The company is suspending its expanded access program for narsoplimab to focus resources on the successful launch [9][10] Q&A Session Summary Question: Can you provide details on launch plans and patient access? - Management expressed confidence in the launch preparations, highlighting engagement with key transplant centers and payers [29][31][34] Question: Can you detail the patient demographics and associated costs? - Management explained that TATMA is a complication of stem cell transplants that can arise unpredictably, leading to significant healthcare costs [41][42] - The economic value of narsoplimab was discussed, emphasizing its potential to reduce costs associated with untreated patients [44][45]

Financial Data and Key Metrics Changes - The company reported a net loss of $33.5 million or $0.58 per share for the first quarter of 2025, compared to a net loss of $31.4 million or $0.54 per share in the fourth quarter of the previous year [5][18] - As of March 31, 2025, the company had $52.5 million in cash and investments on hand [5][18] - The company has reduced its total debt by $10 million and lowered near-term repayment obligations from approximately $118 million to $17 million [6][19] Business Line Data and Key Metrics Changes - Research and development expenses in the first quarter were heavily focused on narsoplimab and zaltanibart [20] - OMIDRIA royalties for the first quarter totaled $6.7 million based on net sales of $22.3 million, a decrease from $10.1 million in royalties on net sales of $33.6 million in the previous quarter [22][23] Market Data and Key Metrics Changes - The market opportunity for narsoplimab is estimated at nearly $1 billion annually, with expectations for it to become a cornerstone asset for transplant experts [11] - The global market for paroxysmal nocturnal hemoglobinuria (PNH) is projected to grow about 11% annually to over $10 billion by 2032 [12] Company Strategy and Development Direction - The company is focused on the anticipated approval and launch of narsoplimab for the treatment of TATMA, with a target FDA action date of September 25 [8] - The company is also working on a marketing authorization application for narsoplimab in Europe, targeting completion later this quarter [9] - Development spending on other programs, including the long-acting MASP-two inhibitor OMS1029, remains limited as the company prioritizes core development initiatives [12][16] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of maintaining financial flexibility and managing costs while advancing key initiatives [7] - The company is actively pursuing partnerships for non-dilutive funding to support operations [6] - Management expressed confidence in the successful launch of narsoplimab, highlighting the compelling data and the unique market position of the product [36] Other Important Information - The company has suspended its expanded access program for narsoplimab to prioritize resources for the anticipated launch [9][10] - The company is committed to supporting patients currently treated under the EAP despite the program's discontinuation [10] Q&A Session Summary Question: Can you provide details on launch plans and patient access? - Management indicated they are well-prepared for the launch, focusing on key transplant centers and engaging with payers for product information exchanges [31][34] Question: Can you elaborate on the patients affected by TATMA and the associated costs? - Management explained that TATMA is a complication of stem cell transplants that can arise unpredictably, leading to significant healthcare costs due to the severity of the condition [42][44]

Financial Data and Key Metrics Changes - The company reported a net loss of $33.5 million or $0.58 per share for the first quarter of 2025, compared to a net loss of $31.4 million or $0.54 per share in the fourth quarter of the previous year [5][19] - As of March 31, 2025, the company had $52.5 million in cash and investments on hand [5][19] - The company has reduced its total outstanding debt by $10 million and lowered its near-term repayment obligations from approximately $118 million to $17 million [6][20] Business Line Data and Key Metrics Changes - Research and development expenses in the first quarter were heavily focused on narsoplimab and zaltanibart [21] - OMIDRIA royalties for the first quarter totaled $6.7 million based on net sales of $22.3 million, a decrease from $10.1 million in royalties on net sales of $33.6 million in the previous quarter [23][24] Market Data and Key Metrics Changes - The market opportunity for narsoplimab is estimated at nearly $1 billion annually, with expectations for it to become a cornerstone asset for transplant experts [12] - The global market for paroxysmal nocturnal hemoglobinuria (PNH) is projected to grow about 11% annually to over $10 billion by 2032 [13] Company Strategy and Development Direction - The company is focused on the successful launch of narsoplimab for the treatment of TATMA, following the anticipated FDA approval [8][9] - The company is also developing zaltanibart, targeting PNH, while managing costs and pausing certain programs to prioritize resources [14][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of narsoplimab, highlighting the preparation and engagement with key transplant centers and payers [35][36] - The company is committed to managing cash and liquidity effectively to support operations and capitalize on growth opportunities [7][49] Other Important Information - The FDA has accepted the resubmitted BLA for narsoplimab, with a target action date of September 25 [9] - The company is also working on a marketing authorization application for narsoplimab in Europe, targeting submission later this quarter [10] Q&A Session Summary Question: Can you provide details on launch plans and patient access? - Management indicated that the commercial team is well-prepared for the launch, focusing on key transplant centers and engaging with payers for product information exchanges [30][31][35] Question: Can you elaborate on the patients affected by TATMA and associated costs? - Management explained that TATMA is a complication of stem cell transplants that can arise unpredictably, leading to significant healthcare costs due to the severity of the condition [38][44] - The economic value of narsoplimab is highlighted by its potential to reduce costs associated with untreated patients, emphasizing outpatient treatment benefits [46][47]

[Part I — Financial Information](index=6&type=section&id=Part%20I%20%E2%80%94%20Financial%20Information) [Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(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 concern**[44](index=44&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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, 2025**[29](index=29&type=chunk)[132](index=132&type=chunk) - The company has **temporarily paused its Phase 3 clinical development program for zaltenibart** in PNH to prioritize available capital[32](index=32&type=chunk)[137](index=137&type=chunk) - 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 Loan[157](index=157&type=chunk)[158](index=158&type=chunk) - 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 capital[179](index=179&type=chunk)[180](index=180&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) 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 reductions[163](index=163&type=chunk) 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 Notes[171](index=171&type=chunk) [Financial Condition – Liquidity and Capital Resources](index=36&type=section&id=Financial%20Condition%20%E2%80%93%20Liquidity%20and%20Capital%20Resources) 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 investments**[178](index=178&type=chunk) - A credit agreement covenant requires the company to maintain **$25.0 million of unrestricted cash**, cash equivalents, and short-term investments at all times[178](index=178&type=chunk) - 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-end[182](index=182&type=chunk) - The company has taken steps to manage expenses by **delaying clinical trials and reducing selected R&D efforts**, with further reductions possible if necessary[183](index=183&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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 funds[195](index=195&type=chunk) - 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 portfolio[195](index=195&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) 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 level[196](index=196&type=chunk) - **No material changes** in internal control over financial reporting occurred during the quarter that are reasonably likely to materially affect these controls[197](index=197&type=chunk) [Part II — Other Information](index=39&type=section&id=Part%20II%20%E2%80%94%20Other%20Information) [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) 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 filing[199](index=199&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.Risk%20Factors) 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 risks[200](index=200&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period - Not applicable[201](index=201&type=chunk) [Other Information](index=39&type=section&id=Item%205.%20Other%20Information) 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, 2025[204](index=204&type=chunk) [Exhibits](index=40&type=section&id=Item%206.%20Exhibits) 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 2002**[205](index=205&type=chunk)