Omeros(US:OMER)2021-03-01 21:30Financial 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]