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Omeros(OMER) - 2024 Q3 - Quarterly Results
2024-11-13 21:06
Financial Performance - Net loss for Q3 2024 was $32.2 million, or $0.56 per share, compared to a net loss of $37.8 million, or $0.60 per share in Q3 2023[1] - Net loss from continuing operations for Q3 2024 was $37,113,000, compared to a loss of $51,656,000 in Q3 2023, reflecting a 28% improvement[31] - The company reported a net loss of $32,232,000 for Q3 2024, which is a 15% decrease from the net loss of $37,750,000 in Q3 2023[31] Cash and Investments - Cash and short-term investments available for operations and debt servicing were $123.2 million, a decrease of $48.7 million from December 31, 2023[2] - Cash and cash equivalents decreased to $1,521,000 as of September 30, 2024, down from $7,105,000 at the end of 2023[33] - Total current assets were $164,921,000 as of September 30, 2024, a decline from $217,898,000 at the end of 2023[33] - Total assets decreased to $313,335,000 as of September 30, 2024, compared to $378,269,000 at the end of 2023[33] - The accumulated deficit increased to $(878,987,000) as of September 30, 2024, from $(753,530,000) at the end of 2023[33] Operating Expenses - Total operating expenses for Q3 2024 were $35.4 million, down from $48.2 million in Q3 2023, primarily due to reduced clinical expenditures[22] - Research and development expenses for Q3 2024 were $24,084,000, a decrease of 24% from $31,731,000 in Q3 2023[31] - Selling, general and administrative expenses for Q3 2024 were $11,323,000, down 31% from $16,422,000 in Q3 2023[31] - Total costs and expenses for Q3 2024 were $35,407,000, a reduction of 26% compared to $48,153,000 in Q3 2023[31] - Interest expense decreased to $4.1 million in Q3 2024 from $7.9 million in the prior year quarter due to retiring convertible notes[23] Product Development and Regulatory Updates - Narsoplimab BLA resubmission is anticipated following a productive FDA presubmission meeting, with plans to conduct primary and secondary efficacy analyses[3] - European MAA for narsoplimab is expected to be submitted in the first half of 2025[4] - Zalatenibart is advancing to Phase 3 enrollment in PNH, expected in early 2025, following successful meetings with FDA and European regulators[5] - OMS1029 has completed Phase 1 studies and is being evaluated for Phase 2 clinical development in large-market indications[12] - OMS527, targeting cocaine use disorder, is set to initiate a randomized clinical study next year, funded by a $6.69 million NIDA grant[17] - The company is advancing its lead MASP-2 inhibitor narsoplimab, with a biologics license application pending before the FDA[29] Revenue from Products - OMIDRIA royalties earned were $9.3 million on U.S. net sales of $31.0 million, compared to $10.0 million on U.S. net sales of $33.3 million in Q3 2023[21]
Omeros(OMER) - 2024 Q2 - Earnings Call Transcript
2024-08-10 05:05
Financial Data and Key Metrics Changes - The net loss for Q2 2024 was $56 million or $0.97 per share, compared to a net loss of $37.2 million or $0.63 per share in Q1 2024 [4][26] - Total cash and investments on hand as of June 30, 2024, were $158.9 million, a decrease of $71.4 million from March 31, 2024 [6][27] - Costs and expenses from continuing operations for Q2 were $59.2 million, an increase of $20.1 million from Q1 2024 [28] Business Line Data and Key Metrics Changes - R&D expenses in Q2 included $17.6 million related to the manufacture of narsoplimab drug substance lots [5][26] - The company incurred $21.2 million in discounted term loan related debt repurchase and $1.9 million in transaction costs [5][27] - OMIDRIA royalties for Q2 were $10.9 million on net sales of $36.4 million, compared to $9.4 million on net sales of $31.2 million in Q1 2024 [29][30] Market Data and Key Metrics Changes - The company has two sales contingent milestones from the sale of OMIDRIA royalties, each up to $27.5 million, payable in January 2026 and January 2028 [6][30] - The debt repurchase transaction reduced the outstanding 2026 notes by 55% from $216 million to $98 million [7][32] Company Strategy and Development Direction - The company is focused on obtaining FDA approval for narsoplimab and is preparing for its resubmission [11][12] - The development program for zaltenibart (MASP-3 inhibitor) is advancing with multiple Phase 2 studies ongoing [13][16] - The company is exploring chronic large value indications for OMS1029, including neovascular age-related macular degeneration [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the data supporting narsoplimab's approval and is actively engaging with the FDA [38][41] - The company is well-prepared for commercialization upon receiving regulatory approval, with plans in place for packaging and branding [39][40] - Management highlighted the need for FDA approval as the primary requirement to move forward with narsoplimab [38][41] Other Important Information - The term loan agreement includes a $25 million delayed draw facility contingent on FDA approval of narsoplimab [9][31] - The company is developing a diagnostic approach for MASP-2 and lectin pathway hyperactivation to drive adoption of narsoplimab [22] Q&A Session Summary Question: Can you provide insights on future expenses? - Management clarified that the significant expenses incurred in Q2 are not expected to be repeated in the future [36] Question: What is needed for market entry post-approval? - Management indicated that FDA approval is crucial, and they are well-prepared for commercialization [38][40] Question: When is the additional FDA meeting expected? - The date of the meeting was not specified, but it involves responses to FDA questions [46] Question: What is the status of zaltenibart and C3G program? - The Phase 2 study is ongoing, and there is an expectation of overlap between Phase 2 and Phase 3 trials [53][54] Question: How quickly can OMS1029 enter the clinic? - If data is favorable, the company anticipates moving into the clinic in early 2025 [55]
Omeros(OMER) - 2024 Q1 - Quarterly Report
2024-05-15 20:09
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 March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the prece ...
Omeros(OMER) - 2024 Q1 - Quarterly Results
2024-05-15 20:07
Exhibit 99.1 Omeros Corporation Reports First Quarter 2024 Financial Results – Conference Call Today at 4:30 p.m. ET SEATTLE, WA – May 15, 2024 – Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today announced recent highlig ...
Omeros(OMER) - 2023 Q4 - Annual Report
2024-04-01 21:20
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to Commission file number: 001-34475 OMEROS CORPORATION (Exact name of registrant as specified in its charter) Washington 91-1663741 ...
Omeros(OMER) - 2023 Q4 - Annual Results
2024-04-01 20:06
Exhibit 99.1 Omeros Corporation Reports Fourth Quarter and Year-End 2023 Financial Results – Conference Call Today at 4:30 p.m. ET SEATTLE, WA – April 1, 2024 – Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today announced ...
Omeros(OMER) - 2023 Q3 - Quarterly Report
2023-11-09 21:06
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 September 30, 2023 or Washington 91-1663741 (State or other jurisdiction of incorporation or organization) 201 Elliott Avenue West Seattle, Washington 98119 (Address of principal executive offices) (Zip Code) Identification Number) (206) 676-5000 (Registrant's telephone number, i ...
Omeros(OMER) - 2023 Q2 - Quarterly Report
2023-08-09 12:05
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, 2023 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-34475 OMEROS CORPORATION (Exact name of registrant as specified in its charter) Washington 91-1663741 (State o ...
Omeros(OMER) - 2023 Q1 - Quarterly Report
2023-05-09 20:08
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 March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-34475 OMEROS CORPORATION (Exact name of registrant as specified in its charter) Washington 91-1663741 (State ...
Omeros(OMER) - 2022 Q4 - Earnings Call Transcript
2023-03-14 03:17
Omeros Corporation (NASDAQ:OMER) Q4 2022 Earnings Conference Call March 13, 2023 4:30 PM ET Company Participants Jennifer Williams - Investor Relations Dr. Greg Demopulos - Chairman and CEO Mike Jacobsen - Chief Accounting Officer Cathy Melfi - Chief Regulatory Officer Steve Whitaker - Chief Clinical Officer Nadia Dac - Vice President and CCO Conference Call Participants Colin Bristow - UBS Steve Brozak - WBB Securities Mary Kate - Bank of America Brandon Folkes - Cantor Serge Belanger - Needham & Company O ...