Financial Data and Key Metrics Changes - Omeros reported a net loss of $37.3 million for Q4 2020, equating to $0.60 per share, with non-cash charges of $3.5 million or $0.06 per share [32][43] - Total revenues for Q4 2020 were $10.6 million, significantly impacted by uncertainty around OMIDRIA reimbursement [30][43] - Cash, cash equivalents, and short-term investments available for operations were $135 million as of December 31, 2020, with an additional $50 million available through a line of credit [32][44] Business Line Data and Key Metrics Changes - OMIDRIA sales in Q4 2020 were $10.6 million, reflecting customer demand despite limited utilization due to reimbursement uncertainties [31][43] - The company reduced its previously recorded reserve for wholesale returns by $5.7 million following confirmation of separate payment for OMIDRIA [47] - The gross to net deductions for OMIDRIA were consistent with prior quarters, indicating stable pricing and demand dynamics [48] Market Data and Key Metrics Changes - The confirmation of separate payment for OMIDRIA by CMS in December 2020 is expected to lead to increased revenues in Q1 2021 as purchasing facilities resume usage [50][51] - The company anticipates a sustained recovery in purchasing facilities and daily average sales volumes for OMIDRIA [32][51] Company Strategy and Development Direction - Omeros is preparing for the anticipated approval and commercial launch of narsoplimab for TA-TMA, with a PDUFA date set for July 17, 2021 [8][11] - The company is expanding its research into narsoplimab for COVID-19 treatment, recognizing its potential role in addressing endothelial injury syndromes [14][15] - Omeros is also advancing its second-generation MASP-2 antibody, OMS1029, targeting once-monthly or less frequent subcutaneous dosing [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing recovery of OMIDRIA sales and the successful launch of narsoplimab, citing strong engagement from the transplant community [10][50] - The company is aware of the NIH initiative for long-hauler COVID-19 research and sees potential for narsoplimab in preventing and treating long-term sequelae [60][61] - Management noted that enrollment in clinical trials, particularly for IGA nephropathy, has been impacted by hospital restrictions due to the pandemic, but efforts are underway to expand patient access [65][66] Other Important Information - Omeros is actively involved in discussions with regulatory authorities in Europe regarding potential funding and clinical trials for narsoplimab in COVID-19 [20] - The company is monitoring legislative developments related to the No Pain Act, which aims to expand access to non-opioid pain management drugs like OMIDRIA [34][96] Q&A Session Summary Question: Can you provide clarity on OMIDRIA sales during the fourth quarter? - Management acknowledged that the uncertainty around reimbursement affected sales, but noted that sales improved after CMS confirmed separate payment in early December [55][56] Question: What is the company's plan for narsoplimab regarding long-haulers? - Management indicated that they are considering studying narsoplimab for long-term sequelae of COVID-19, noting that treated patients showed no evidence of sequelae [60][61] Question: What challenges are being faced in the IGA nephropathy trial enrollment? - Management explained that enrollment challenges are primarily due to hospital-specific restrictions rather than issues related to the disease itself [66][67] Question: What are the expectations for the I-SPY program involving narsoplimab? - Management clarified that the I-SPY trial is independent and aims to assess the effectiveness of drugs in COVID-19, with narsoplimab being the only complement inhibitor involved [74][75] Question: How does the company view the commercialization strategy for OMIDRIA in 2021? - Management stated that the current sales force is sufficient and that they are focusing on partnerships with ASC chains to drive cataract surgery volume [95][96]

Financial Position - As of December 31, 2020, the company had cash, cash equivalents, and short-term investments totaling $135.0 million[362] - Total current assets increased to $151.3 million in 2020 from $103.7 million in 2019, reflecting a significant growth in short-term investments[381] - The company's accumulated deficit grew to $872.7 million as of December 31, 2020, compared to $734.6 million in the previous year[381] - The total liabilities and shareholders' deficit reached $181.0 million in 2020, up from $137.0 million in 2019[381] - Cash and cash equivalents at the end of 2020 were $10.501 million, an increase from $3.084 million at the beginning of the year[388] - As of December 31, 2020, total accounts receivable, net was $3.841 million, a decrease from $35.185 million in 2019[440] - Total inventory as of December 31, 2020, was $1.355 million, up from $1.147 million in 2019[445] - Total accrued expenses decreased to $28.755 million in 2020 from $46.627 million in 2019[449] - The company had no outstanding borrowings under the Line of Credit Agreement as of December 31, 2020[456] - Total lease liabilities as of December 31, 2020, were $32,552,000, down from $35,822,000 in 2019, a decrease of about 9%[479] Revenue and Sales Performance - For the year ended December 31, 2020, revenue deductions amounted to $33.4 million, requiring complex estimates related to inventory and experience ratios[372] - Product sales for the year ended December 31, 2020, were $73.813 million, a decrease of 34% from $111.805 million in 2019[384] - Product sales for Q4 2020 were $10,632 thousand, a decrease from $29,856 thousand in Q4 2019[504] - The COVID-19 pandemic significantly impacted elective cataract procedures, affecting revenue from mid-March to late June 2020[505] Expenses and Losses - Total costs and expenses for 2020 were $184.414 million, up from $175.187 million in 2019, representing an increase of 0.7%[384] - The net loss for 2020 was $138.061 million, compared to a net loss of $84.486 million in 2019, indicating a 63% increase in losses[384] - Basic and diluted net loss per share for 2020 was $2.41, compared to $1.71 in 2019[384] - The net loss for Q4 2020 was $37,273 thousand, compared to $29,225 thousand in Q4 2019[505] - The company incurred stock-based compensation expenses of $14.925 million in 2020, up from $13.785 million in 2019[388] - The company reported a loss on early extinguishment of debt amounting to $13.374 million in 2020[388] - The company incurred a loss of $13.0 million on early extinguishment of debt associated with the repayment of a note payable[451] Debt and Financing - The company issued $225 million of 5.25% Convertible Senior Notes due 2026, requiring separate accounting for debt and equity components[373] - The company may pursue debt financings or public and private offerings of equity securities to manage cash flow and operational expenses[396] - The company issued $210.0 million in aggregate principal amount of 6.25% Convertible Senior Notes in November 2018 and $225.0 million in aggregate principal amount of 5.25% Convertible Senior Notes in August and September 2020[409] - The total outstanding Convertible Senior Notes amounted to $320.030 million, with $95.000 million in 2023 Notes and $225.030 million in 2026 Notes[459] - The total interest expense recognized for the 2023 Notes in 2020 was $18.807 million, down from $22.321 million in 2019[466] - Future minimum payments under the Convertible Senior Notes total $320.030 million, with $95.000 million due in 2023 and $225.030 million due in 2026[476] Regulatory and Market Considerations - The company plans to rely on contract manufacturers for the production of OMIDRIA and narsoplimab, pending regulatory approvals[1] - The company is awaiting FDA approval for the BLA of narsoplimab in HSCT-TMA, with potential EMA filing for marketing authorization[1] - The company expects to face commercial competition for OMIDRIA and its product candidates if they are commercialized[1] - The Centers for Medicare and Medicaid Services confirmed that OMIDRIA qualifies for separate payment under Medicare Part B effective retroactively from October 1, 2020[505] Tax and Deferred Assets - As of December 31, 2020, the company had federal net operating loss carryforwards of approximately $658.8 million, up from $564.3 million in 2019[497] - The total deferred tax assets increased from $199,870,000 in 2019 to $244,598,000 in 2020, a growth of about 22%[497] - The effective tax rate for 2020 was (8.0)%, compared to (9.3)% in 2018[500] - The valuation allowance increased by $37.8 million in 2020 and $23.9 million in 2019 due to net operating losses[500] Lease and Asset Management - The company recorded a right-of-use asset of $17.7 million and lease liabilities of $26.4 million upon adopting new lease accounting standards[405] - Total lease assets decreased from $30,055,000 in 2019 to $27,348,000 in 2020, a decline of approximately 9%[479] - Net lease costs increased from $7,688,000 in 2019 to $9,310,000 in 2020, representing a rise of about 21%[480] - Cash paid for operating leases rose to $10,103,000 in 2020 from $6,951,000 in 2019, an increase of approximately 45%[480] - The weighted-average remaining lease term for operating leases decreased from 7.8 years in 2019 to 6.8 years in 2020[479] Research and Development - Research and development expenses include contracted research and manufacturing costs, clinical study costs, and personnel costs, with all costs expensed as incurred[421] - Selling, general and administrative expenses were $5.6 million, $8.0 million, and $2.5 million for the years ended December 31, 2020, 2019, and 2018, respectively[422] - The company has not recognized any impairment losses for long-lived assets for the years ended December 31, 2020, 2019, and 2018[413] - The company allows for product returns up to 12 months past expiration, estimating returns based on historical experience and remaining shelf-life[420] - The company maintains reasonable levels of drug supply for commercial and clinical trial use, with alternative manufacturers available if needed[431] - The company evaluates investments for impairment based on market value, financial condition of the investee, and intent to retain the investment[399] Shareholder Information - The company reported a total of 1,596,124 potentially dilutive shares excluded from diluted EPS for the year ended December 31, 2020[439] - The company issued 6.9 million shares at a public offering price of $14.50 per share in August 2020, resulting in net proceeds of $93.7 million[485] - Approximately 12.2 million shares remain outstanding under the 2026 Capped Call, which is designed to mitigate dilution from the conversion of the 2026 Notes[472]

Omeros Corp (NASDAQ:OMER) Q3 2020 Earnings Conference Call November 9, 2020 4:30 PM ET Company Participants Jennifer Williams - IR Greg Demopulos - Co-Founder, Chairman, CEO & President Michael Jacobsen - CAO, VP, Finance & Treasurer Daniel Kirby - Chief Commercial Officer, VP & Head, Commercial Conference Call Participants Steve Brozak - WBB Securities Raghuram Selvaraju - H.C. Wainwright & Co. Brandon Folkes - Cantor Fitzgerald & Co. Operator Good afternoon and welcome to today's earnings call for Omeros ...

OMS906: Monoclonal Antibody Targeting MASP-3 October 2020 | --- | --- | |-----------------------------------------------------------------------------------|---------------| | Lectin and Alternative Pathway Activation | | | "MBL-associated serine proteases" | | | Three MASPs can form complexes with five possible pattern recognition molecules | | | Serine protease with pattern binding potential | | | Lectins, via carbohydrate recognition domains (CRD), bind molecular patterns | | | on microbes or damaged/alt ...

June 2020 Omeros Corporate Presentation Safe Harbor This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of Omeros Corporation. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Omeros' actual results and the timing and outcome of events may differ materiall ...

Omeros Corporation (NASDAQ:OMER) Q1 2020 Earnings Conference Call May 11, 2020 4:30 PM ET Company Participants Jennifer Williams – Investor Relations Greg Demopulos – Chairman and Chief Executive Officer Mike Jacobsen – Chief Accounting Officer Conference Call Participants Steve Brozak – WBB Brandon Folkes – Cantor Fitzgerald Operator Good afternoon and welcome to today's Earnings Call for Omeros Corporation. [Operator Instructions] Please be advised that this call is being recorded at the company's request ...

Omeros Corporation (NASDAQ:OMER) Q4 2019 Earnings Conference Call March 2, 2020 4:30 PM ET CompanyParticipants Jennifer Williams - IR, Cook Williams Communications, Inc. Greg Demopulos - Chairman & Chief Executive Officer Mike Jacobsen - Chief Accounting Officer Catherine Melfi - Chief Regulatory Officer Conference Call Participants Steve Brozak - WBB Brandon Folkes - Cantor Fitzgerald Operator Good afternoon and welcome to today's conference call for Omeros Corporation. At this time, all participants are i ...

Omeros Corporation (NASDAQ:OMER) Q3 2019 Earnings Conference Call November 12, 2019 4:30 PM ET Company Participants Jennifer Williams - IR, Cook Williams Communications, Inc. Greg Demopulos - Chairman & Chief Executive Officer Mike Jacobsen - Chief Accounting Officer Conference Call Participants Ram Selvaraju - H.C. Wainwright Steve Brozak - WBB Serge Belanger - Needham & Company Operator Good afternoon and welcome to today's conference call for Omeros Corporation. At this time, all participants are in a li ...

Omeros Corporation (NASDAQ:OMER) Q2 2019 Earnings Conference Call August 8, 2019 4:30 PM ET Company Participants Jennifer Williams - Investor Relations Greg Demopulos - Chairman and Chief Executive Officer Mike Jacobsen - Chief Accounting Officer Conference Call Participants Steve Brozak - WBB Brandon Folkes - Cantor Ram Selvaraju - H.C. Wainwright Tian Sun - Needham Operator Good afternoon, and welcome to today's Conference Call for Omeros Corporation. At this time, all participants are in listen-only mode ...

Next-Generation Therapeutics Transforming Patient Care Today 2019 UBS Global Healthcare Conference Gregory A. Demopulos, M.D. Chairman & CEO May 22, 2019 1 Safe Harbor This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of Omeros Corporation. These statements are not guarantees of future performance and involve risks and uncertain ...