Omeros(US:OMER)2021-11-10 02:05Financial Data and Key Metrics Changes - Net revenue from sales of OMIDRIA in Q3 2021 was $30 million, up 4.1% from $28.8 million in the prior quarter [20][37] - The net loss for Q3 2021 was $22.7 million, or $0.36 per share, including non-cash expenses of $6.4 million, or $0.10 per share [20][37] - As of September 30, 2021, the company had $54.4 million in cash, cash equivalents, and short-term investments [20] Business Line Data and Key Metrics Changes - OMIDRIA revenue grew by 4.1% driven by the Ambulatory Surgical Center (ASC) segment, which has fully recovered following the restoration of separate reimbursement [26][37] - The ASC segment surpassed Q3 2020 sales performance by 7% [26] - Weekly sales in ASCs have achieved repeated all-time highs in Q4 2021 [22][38] Market Data and Key Metrics Changes - The Centers for Medicare & Medicaid Services (CMS) reconfirmed separate payment for OMIDRIA in the ASC setting, which is expected to drive revenue growth [22][41] - The No Pain Act, if passed, would provide separate payment for non-opioid pain management drugs like OMIDRIA, further supporting market growth [24] Company Strategy and Development Direction - The company is focused on resolving the Narsoplimab BLA matter and is managing expenditures tightly [20][21] - Narsoplimab is being evaluated in multiple indications, including IgA nephropathy, atypical hemolytic uremic syndrome, and COVID-19 [11][16] - The company is advancing its MASP-3 program and plans to initiate a PNH program in early 2022 [33][62] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data supporting Narsoplimab and is hopeful for a favorable outcome from the upcoming FDA meeting [10][56] - There is strong support from thought leaders for Narsoplimab, highlighting the urgency for its approval due to the lack of existing treatments for TA-TMA [51][52] - The company anticipates continued growth in OMIDRIA revenues as ASC customers increase their usage [41][76] Other Important Information - The company has an unused line of credit with borrowing availability up to $50 million based on accounts receivable [21] - The company is exploring options for external funding sources for its phosphodiesterase 7 inhibitor program [34] Q&A Session Summary Question: Comments on the CRL and potential new controlled trial funding - Management does not expect a new controlled trial will be required and is targeting an end of 2022 readout for the IGAN phase 3 trial [45] Question: Update on OMS906 program and potential PNH data - The PNH program is expected to initiate early in 2022, with a focus on demonstrating the benefits of OMS906 over other alternative pathway inhibitors [48] Question: Support from clinicians regarding Narsoplimab - Thought leaders expressed surprise and disappointment at the CRL but remain supportive of Narsoplimab, with ongoing requests for compassionate use [51][53] Question: Path forward for Narsoplimab and nephrology indications - Management is hopeful for a class one resubmission and sees potential for Narsoplimab in broader renal diseases beyond IgA nephropathy [56][59] Question: Differentiation of OMS906 from other products - OMS906 targets the alternative pathway, while Narsoplimab and OMS1029 focus on the lectin pathway, with different dosing advantages for chronic diseases [62]