Omeros(US:OMER)2022-11-10 03:34Financial Data and Key Metrics Changes - The company reported a net loss of $17.5 million or $0.28 per share for Q3 2022, an improvement from a loss of $22.7 million or $0.36 per share in Q3 2021 [21] - Non-cash expenses were $4.6 million or $0.07 per share for the current quarter, down from $6.4 million or $0.10 per share in the prior year quarter [22] - Total cash burn for the quarter was $26.6 million, with approximately $5 million attributed to manufacturing costs [22] - As of September 30, 2022, the company had $221 million in cash and investments, including $125 million received from DRI Healthcare Trust [24] Business Line Data and Key Metrics Changes - The company earned $16.5 million in royalties from Rayner's net sales of OMIDRIA, a decrease of approximately $700,000 from Q2 2022 due to timing of wholesaler purchases [23] - Rayner's unit sell-through to ASCs and hospitals increased by 4% over the second quarter [23] - Discontinued operations included $37 million of income, recognizing $8 million of interest earned and $29 million in remeasurement adjustments to the OMIDRIA contract royalty asset [58] Market Data and Key Metrics Changes - The company expects continued growth in OMIDRIA sales for Q4 2022, supported by CMS reaffirming OMIDRIA's qualification for separate payment under the outpatient prospective payment system [33] - The NOPAIN Act, which would provide separate payment for non-opioid pain management drugs like OMIDRIA, is gaining bipartisan support and could trigger a $200 million milestone payment to the company [35] Company Strategy and Development Direction - The company is focusing on the development of narsoplimab for TA-TMA and is working through FDA's recent decision regarding the path forward [8][10] - The company is advancing its OMS1029 and OMS906 programs, with plans for multiple ascending dose studies and initial patient data expected in early 2023 [13][15] - The company aims to leverage its MASP-2 portfolio and is closing in on a lead development candidate for a small molecule MASP-2 inhibitor [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the approval of narsoplimab for TA-TMA, stating that abandoning the path forward is not an option [65] - The company is committed to getting narsoplimab approved as quickly as possible, emphasizing the urgent need for treatment in the market [107] - Management highlighted the importance of strong advocacy within the expert community to support the approval process [85] Other Important Information - The company recorded the $125 million upfront payment from DRI as a liability, consistent with accounting practices for asset sales [31][52] - The structure of the DRI transaction shifts risk from the company to DRI, particularly regarding the ability to generate OMIDRIA royalty streams [28] Q&A Session Summary Question: Is there an outcome where the company would abandon the TA-TMA indication? - Management believes that narsoplimab should be approved and abandoning the path forward is not an option [65] Question: How comfortable is the company with the mechanism of action for COVID? - Management provided detailed insights into the mechanism of action and its relevance to both COVID and TA-TMA, citing published data [79] Question: What is the minimum survival benefit the FDA would want to see for narsoplimab? - Management has not discussed specific thresholds with the FDA but believes the survival benefit observed exceeds literature expectations [91] Question: How close is the company to full enrollment in the IGAN trial? - Enrollment is wrapping up, and the study is powered at 90% to detect differences in proteinuria [92] Question: What options is the company considering regarding the FDA's request for historical control data? - The company is considering a broad range of options, including addressing the historical control request [104]