Omeros(OMER)

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Omeros(OMER) - 2022 Q4 - Annual Report
2023-03-13 20:09
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, 2022 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) (State or other jurisdiction of in ...
Omeros(OMER) - 2022 Q3 - Earnings Call Transcript
2022-11-10 03:34
Omeros Corporation (NASDAQ:OMER) Q3 2022 Earnings Conference Call November 9, 2022 4:30 PM ET Company Participants Jennifer Williams - Investor Relations Greg Demopulos - Chairman & Chief Executive Officer Mike Jacobsen - Chief Accounting Officer Cathy Melfi - Chief Regulatory Officer Steve Whitaker - Chief Clinical Officer Conference Call Participants Colin Bristow - UBS Steve Brozak - WBB Securities Eric Joseph - JPMorgan Mary Kate - Bank of America Brandon Folkes - Cantor Serge Belanger - Needham. Opera ...
Omeros(OMER) - 2022 Q3 - Quarterly Report
2022-11-09 21:11
Part I — Financial Information [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements detail the company's financial position, operations, equity, and cash flows [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets grew to $457.6 million while a new royalty obligation increased total liabilities, resulting in a shareholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $145,533 | $100,808 | | OMIDRIA contract royalty asset (Total) | $191,385 | $184,570 | | **Total Assets** | **$457,551** | **$419,268** | | **Liabilities & Equity** | | | | Unsecured convertible senior notes, net | $314,819 | $313,458 | | OMIDRIA royalty obligation | $125,000 | $0 | | **Total Liabilities** | **$503,865** | **$395,488** | | **Total Shareholders' Equity (Deficit)** | **($46,314)** | **$23,780** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The Q3 2022 net loss improved to $17.5 million, as income from discontinued operations offset a wider loss from continuing operations Q3 2022 vs Q3 2021 Statement of Operations (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | | :--- | :--- | :--- | | Research and development | $38,568 | $25,818 | | Selling, general and administrative | $12,198 | $14,010 | | **Loss from continuing operations** | **($50,766)** | **($39,828)** | | Net income from discontinued operations | $37,336 | $21,575 | | **Net loss** | **($17,456)** | **($22,703)** | | **Net loss per share** | **($0.28)** | **($0.36)** | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash increased by $44.7 million in the first nine months of 2022, driven by a $124.9 million inflow from financing activities Nine Months Ended Sep 30 Cash Flow Summary (in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($61,101) | ($91,507) | | Net cash (used in) provided by investing activities | ($19,073) | $81,292 | | Net cash provided by financing activities | $124,899 | $7,129 | | **Net increase (decrease) in cash** | **$44,725** | **($3,086)** | | **Cash and cash equivalents at end of period** | **$145,533** | **$7,415** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail key accounting policies, the OMIDRIA sale and royalty transactions, and the regulatory status of narsoplimab - The company is a clinical-stage biopharmaceutical firm whose lead candidate, narsoplimab, received a **Complete Response Letter (CRL)** from the FDA for HSCT-TMA, and an appeal was denied[24](index=24&type=chunk)[25](index=25&type=chunk) - On December 23, 2021, Omeros sold its commercial product OMIDRIA to Rayner Surgical Inc. for **$126.0 million upfront**, with results now reported as discontinued operations[28](index=28&type=chunk)[29](index=29&type=chunk) - On September 30, 2022, the company sold a portion of its future OMIDRIA royalty receipts to DRI Healthcare for **$125.0 million in cash**, recorded as a liability[39](index=39&type=chunk)[40](index=40&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its clinical pipeline, the financial impact of the OMIDRIA divestiture, and its capital sufficiency for future operations [Overview](index=32&type=section&id=Overview) The overview covers the regulatory status of narsoplimab and details financial transactions related to the OMIDRIA sale and royalty monetization - The FDA's Office of New Drugs (OND) denied the company's appeal regarding the narsoplimab BLA for HSCT-TMA but proposed a **resubmission path based on survival data**[95](index=95&type=chunk) - On December 23, 2021, Omeros sold OMIDRIA to Rayner for **$126.0 million upfront**, retaining rights to significant royalties and a potential **$200.0 million milestone payment**[99](index=99&type=chunk) - On September 30, 2022, Omeros received **$125.0 million in cash** from DRI Healthcare in exchange for a portion of future OMIDRIA royalty receipts[100](index=100&type=chunk) [Clinical Development Programs](index=34&type=section&id=Clinical%20Development%20Programs) The clinical pipeline is led by narsoplimab (MASP-2 inhibitor) and includes other key programs like OMS1029, OMS906, and OMS527 - **Narsoplimab (MASP-2):** The ARTEMIS-IGAN Phase 3 trial for IgA nephropathy continues enrollment, with 9-month proteinuria data anticipated by **mid-2023**[106](index=106&type=chunk) - **OMS1029 (long-acting MASP-2):** A Phase 1 clinical trial began dosing in August 2022 for this **once-monthly to once-quarterly** drug[114](index=114&type=chunk) - **OMS906 (MASP-3):** Following a successful Phase 1 trial, a Phase 1b trial is being initiated in PNH patients, with program expansion planned for other indications[118](index=118&type=chunk)[119](index=119&type=chunk) [Results of Operations](index=44&type=section&id=Results%20of%20Operations) R&D expenses rose to $38.6 million in Q3 2022 due to narsoplimab manufacturing, while SG&A expenses decreased to $12.2 million Research and Development Expenses (in thousands) | Category | Q3 2022 | Q3 2021 | | :--- | :--- | :--- | | MASP-2 program - OMS721 (narsoplimab) | $23,097 | $10,057 | | Total clinical research and development | $26,785 | $11,839 | | Preclinical research and development | $1,125 | $1,998 | | **Total R&D Expenses** | **$38,568** | **$25,818** | Selling, General and Administrative Expenses (in thousands) | Category | Q3 2022 | Q3 2021 | | :--- | :--- | :--- | | SG&A (excl. stock-based comp) | $9,998 | $11,104 | | Stock-based compensation | $2,200 | $2,906 | | **Total SG&A Expenses** | **$12,198** | **$14,010** | Net Income from Discontinued Operations (in thousands) | Category | Q3 2022 | Q3 2021 | | :--- | :--- | :--- | | Product sales, net | $0 | $30,004 | | Royalty interest income and other | $8,229 | $0 | | Remeasurement adjustments | $29,043 | $0 | | **Net income from discontinued ops** | **$37,336** | **$21,575** | [Financial Condition - Liquidity and Capital Resources](index=49&type=section&id=Financial%20Condition%20-%20Liquidity%20and%20Capital%20Resources) The company ended Q3 2022 with $221.0 million in cash and investments, deemed sufficient to fund operations through at least November 2023 - The company ended Q3 2022 with **$221.0 million in cash**, cash equivalents, and short-term investments[145](index=145&type=chunk) - The third quarter cash burn, excluding the $125.0 million from the DRI transaction, was **$26.6 million**[145](index=145&type=chunk) - The company has **$95.0 million of 2023 Convertible Senior Notes** that mature and become due in November 2023[146](index=146&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=53&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Market risk is primarily limited to the investment portfolio, which is managed to preserve capital through high-quality, short-term securities - Market risk is primarily confined to the company's investment portfolio of **$221.0 million** in cash, cash equivalents, and short-term investments[160](index=160&type=chunk) - The investment policy is to invest in **highly liquid, investment-grade securities** with short-term maturities to preserve capital and minimize risk[160](index=160&type=chunk) [Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2022, with no material changes to internal controls - The principal executive officer and principal financial officer concluded that as of September 30, 2022, the company's disclosure controls and procedures were **effective**[161](index=161&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[162](index=162&type=chunk) Part II — Other Information [Legal Proceedings](index=55&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it was not involved in any material legal proceedings as of the filing date - Omeros Corporation was **not involved in any material legal proceedings** as of the filing date of this Form 10-Q[165](index=165&type=chunk) [Risk Factors](index=55&type=section&id=Item%201A.%20Risk%20Factors) This section refers investors to the risk factors disclosed in the company's 2021 Annual Report on Form 10-K - The company refers to the risk factors described in its Annual Report on Form 10-K for the year ended December 31, 2021, indicating **no material changes** during the quarter[166](index=166&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=55&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period [Default Upon Senior Securities](index=55&type=section&id=Item%203.%20Default%20Upon%20Senior%20Securities) This item is not applicable for the reporting period [Mine Safety Disclosures](index=55&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable for the reporting period [Other Information](index=55&type=section&id=Item%205.%20Other%20Information) This item is not applicable for the reporting period [Exhibits](index=55&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the Royalty Purchase Agreement and officer certifications - Key exhibits filed include the **Royalty Purchase Agreement** with DRI Healthcare Acquisitions LP, and certifications from the Principal Executive Officer and Principal Financial Officer[171](index=171&type=chunk)
Omeros(OMER) - 2022 Q2 - Earnings Call Transcript
2022-08-10 00:33
Omeros Corporation. (NASDAQ:OMER) Q2 2022 Earnings Conference Call August 9, 2022 4:30 PM ET Company Participants Jennifer Williams - Investor Relations Gregory Demopulos - Chairman & Chief Executive Officer Mike Jacobsen - Chief Accounting Officer Cathy Melfi - Chief Regulatory Officer Steve Whitaker - Chief Clinical Officer Nadia Dac - Chief Commercial Officer Conference Call Participants Greg Harrison - Bank of America Steve Brozak - WBB Hannah Adeoye - JPMorgan Brandon Folkes - Cantor Fitzgerald Operato ...
Omeros(OMER) - 2022 Q2 - Quarterly Report
2022-08-09 20:17
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 June 30, 2022 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) - 2022 Q1 - Earnings Call Transcript
2022-05-11 02:26
Financial Data and Key Metrics Changes - The company reported a net loss of $33 million or $0.53 per share for Q1 2022, compared to a loss of $35.1 million or $0.57 per share in the same quarter of the previous year [32][57] - Non-cash expenses were $4.2 million or $0.07 per share, consistent with the prior year [32][57] - Cash and investments decreased by $15 million from the previous year-end, totaling $142.2 million as of March 31, 2022 [36][58] Business Line Data and Key Metrics Changes - The OMIDRIA product line was divested to Rayner Surgical, leading to a reclassification of historical revenues and expenses into discontinued operations [31][54] - OMIDRIA net sales reported by Rayner for Q1 2022 were $27.8 million, representing a 31% increase from $21.1 million in Q1 2021 [33][34] - The company earned $13.8 million in royalties from OMIDRIA sales, reflecting a 50% royalty rate on net sales [34][61] Market Data and Key Metrics Changes - The first quarter is typically the lowest for cataract procedure volume, historically resulting in weaker OMIDRIA sales, but growth is expected to continue [35] - The company has $16.3 million in receivables primarily related to OMIDRIA royalties, expected to be collected shortly [36][58] Company Strategy and Development Direction - The company is focused on advancing its MASP-2 and MASP-3 programs, with ongoing trials for narsoplimab in various indications [22][42] - The company is pursuing a dispute resolution process with the FDA regarding narsoplimab, aiming for regular approval based on existing data [11][14] - The company is also exploring life cycle management for its MASP-2 program with OMS1029, a long-acting second-generation antibody [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of their data and the likelihood of a favorable outcome from the FDA dispute resolution process [14][90] - The company anticipates near-term value-driving milestones throughout 2022 and is committed to advancing its pipeline [100] Other Important Information - The company has a $150 million at-the-market sales agreement that has not yet been utilized [36] - The enactment of the NOPAIN Act could provide a $200 million milestone if separate payment for OMIDRIA is secured for a continuous period of four years [38][39] Q&A Session Summary Question: What is the optimal outcome from the dispute process regarding narsoplimab? - The company is requesting regular approval based on existing data, with the optimal outcome being agreement with their position leading to label discussions [70][72] Question: What critiques were repeated by the FDA after the Type A meeting? - The company addressed specific critiques regarding the interpretation of treatment response, which they believed had been adequately resolved [85][86] Question: What happens if the company does not prevail in the dispute resolution? - The company has considered alternative scenarios but remains confident in the strength of their data and the likelihood of a successful outcome [94][96]
Omeros(OMER) - 2022 Q1 - Quarterly Report
2022-05-10 20:24
Part I — Financial Information [Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20%28unaudited%29) Omeros reported a Q1 2022 net loss of $33.0 million, an improvement from $35.1 million in Q1 2021, with total assets of $369.3 million and a shareholders' deficit of $4.9 million, reflecting the impact of OMIDRIA's sale [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $369.3 million from $419.3 million, primarily due to reduced cash, leading to a $4.9 million shareholders' deficit as of March 31, 2022 Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $ 8,963 | $ 100,808 | | Short-term investments | $ 133,271 | $ 56,458 | | Total current assets | $ 210,222 | $ 247,956 | | Total assets | $ 369,263 | $ 419,268 | | **Liabilities and Shareholders' Equity (Deficit)** | | | | Total current liabilities | $ 35,066 | $ 51,789 | | Unsecured convertible senior notes, net | $ 313,904 | $ 313,458 | | Total liabilities | $ 374,188 (Calculated) | $ 395,488 (Calculated) | | Total shareholders' equity (deficit) | $ (4,925) | $ 23,780 | | Total liabilities and shareholders' equity (deficit) | $ 369,263 | $ 419,268 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Omeros reported a Q1 2022 net loss of $33.0 million ($0.53 per share), an improvement from $35.1 million in Q1 2021, driven by reduced operating expenses and $6.5 million from discontinued operations Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $ 24,087 | $ 32,504 | | Selling, general and administrative | $ 10,959 | $ 12,786 | | Total costs and expenses | $ 35,046 | $ 45,290 | | Loss from continuing operations | $ (35,046) | $ (45,290) | | Net loss from continuing operations | $ (39,494) | $ (49,769) | | Net income from discontinued operations | $ 6,483 | $ 14,679 | | **Net loss** | **$ (33,011)** | **$ (35,090)** | | **Net loss per share (basic and diluted)** | **$ (0.53)** | **$ (0.57)** | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20%28Deficit%29) Shareholders' equity shifted from a $23.8 million positive balance to a $4.9 million deficit by March 31, 2022, primarily due to the $33.0 million net loss, partially offset by stock-based compensation Shareholders' Equity (Deficit) Rollforward Q1 2022 (in thousands) | Description | Amount | | :--- | :--- | | Balance at January 1, 2022 | $ 23,780 | | Stock-based compensation expense | $ 3,892 | | Net loss | $ (33,011) | | Exercise of stock options and warrants | $ 414 | | **Balance at March 31, 2022** | **$ (4,925)** | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to $15.2 million in Q1 2022, while investing activities used $76.8 million, resulting in a $91.8 million decrease in cash and equivalents, ending at $9.0 million Condensed Consolidated Statements of Cash Flows (in thousands) | | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $ (15,193) | $ (40,254) | | Net cash provided by (used in) investing activities | $ (76,813) | $ 32,985 | | Net cash provided by financing activities | $ 161 | $ 5,796 | | **Net decrease in cash and cash equivalents** | **$ (91,845)** | **$ (1,473)** | | Cash and cash equivalents at end of period | $ 8,963 | $ 9,028 | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail OMIDRIA's sale as a discontinued operation, the FDA's CRL for narsoplimab with planned appeal, and outstanding convertible senior notes totaling $320 million - The company sold its **OMIDRIA assets** on **December 23, 2021**, and now recognizes income from **discontinued operations**, which includes **royalties** and **remeasurement adjustments** of the contract royalty asset[29](index=29&type=chunk)[30](index=30&type=chunk)[39](index=39&type=chunk) - Following a **Complete Response Letter (CRL)** from the **FDA** for **narsoplimab** in **HSCT-TMA**, the company plans to submit a **Formal Dispute Resolution Request** to appeal the decision and seek approval based on the existing BLA data[27](index=27&type=chunk) OMIDRIA Contract Royalty Asset Rollforward Q1 2022 (in thousands) | Description | Amount | | :--- | :--- | | OMIDRIA contract royalty asset at December 31, 2021 | $ 184,570 | | Royalties earned | $ (13,831) | | Royalty interest income and remeasurement adjustments | $ 6,996 | | **OMIDRIA contract royalty asset at March 31, 2022** | **$ 177,735** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical pipeline focus, particularly narsoplimab's FDA appeal, and reduced Q1 2022 R&D and SG&A expenses, noting $142.2 million in cash and investments for future operations [Overview](index=31&type=section&id=Overview) Omeros, a clinical-stage biopharmaceutical company, is appealing the FDA's CRL for narsoplimab in HSCT-TMA, following the December 2021 sale of OMIDRIA for $126 million upfront plus royalties - The company received a **Complete Response Letter (CRL)** from the **FDA** for its **narsoplimab BLA** in **HSCT-TMA** and plans to submit a **Formal Dispute Resolution Request** to appeal the decision[87](index=87&type=chunk) - On **December 23, 2021**, Omeros sold **OMIDRIA** to **Rayner**, receiving **~$126.0 million upfront**. Omeros will receive a **50% royalty** on U.S. net sales until early 2025 (or a milestone payment), after which the royalty becomes **30%**. A **$200.0 million milestone payment** is contingent on securing separate Medicare Part B payment for at least four years before January 1, 2025[90](index=90&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk) [Clinical Development Programs](index=33&type=section&id=Clinical%20Development%20Programs) The company's clinical pipeline includes narsoplimab (MASP-2) in Phase 3 for IgA nephropathy and aHUS, OMS906 (MASP-3) advancing to Phase 1b for PNH, and OMS527 (PDE7) for addiction, pending further resource allocation - **Narsoplimab (MASP-2):** The company is pursuing a **Formal Dispute Resolution** for **HSCT-TMA** approval. Phase 3 trials are ongoing for **IgA nephropathy (ARTEMIS-IGAN)** and **aHUS**. It is also being studied in the **I-SPY COVID-19 trial**[93](index=93&type=chunk)[95](index=95&type=chunk)[97](index=97&type=chunk) - **OMS906 (MASP-3):** Following a successful single-ascending-dose Phase 1 trial, the company plans to advance directly to a **Phase 1b clinical trial** in patients with **PNH**, expecting enrollment to begin in **summer 2022**[102](index=102&type=chunk) - **OMS527 (PDE7):** A **Phase 1 trial** for addiction treatment was successfully completed, but further clinical development is contingent on internal resource allocation or external funding[102](index=102&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Total costs and expenses from continuing operations decreased to $35.0 million in Q1 2022, driven by lower R&D and SG&A expenses, while discontinued operations contributed $6.5 million in net income Research and Development Expenses (in thousands) | Category | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | MASP-2 program - OMS721 (narsoplimab) | $ 9,244 | $ 17,031 | | MASP-3 program - OMS906 | $ 1,302 | $ 1,771 | | Total direct external expenses | $ 13,417 | $ 21,655 | | **Total continuing R&D expenses** | **$ 24,087** | **$ 32,504** | Selling, General and Administrative Expenses (in thousands) | Category | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | SG&A (excl. stock-based comp) | $ 8,782 | $ 11,176 | | Stock-based compensation | $ 2,177 | $ 1,610 | | **Total continuing SG&A expense** | **$ 10,959** | **$ 12,786** | Net Income from Discontinued Operations (in thousands) | | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Product sales, net | $ — | $ 21,061 | | Royalty interest income and remeasurement | $ 6,996 | $ — | | Costs and expenses | $ 513 | $ 6,382 | | **Net income from discontinued operations** | **$ 6,483** | **$ 14,679** | [Financial Condition, Liquidity and Capital Resources](index=44&type=section&id=Financial%20Condition%2C%20Liquidity%20and%20Capital%20Resources) As of March 31, 2022, the company held $142.2 million in cash and investments, deemed sufficient for the next year, with future obligations including $95.0 million in 2023 Convertible Notes - The company ended Q1 2022 with **$142.2 million** in cash, cash equivalents, and short-term investments[123](index=123&type=chunk) - Future funding sources include existing cash, **OMIDRIA royalties**, a potential **$200M milestone**, a **$150M 'at the market' equity offering facility**, and potential **narsoplimab sales** if approved[124](index=124&type=chunk) - The company must address the **$95.0 million** of **2023 Convertible Senior Notes** that mature in **November 2023**[124](index=124&type=chunk) Selected Cash Flow Data (in thousands) | | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Cash used in Operating activities | $ (15,193) | $ (40,254) | | Cash (used in) provided by Investing activities | $ (76,813) | $ 32,985 | | Cash provided by Financing activities | $ 161 | $ 5,796 | [Quantitative and Qualitative Disclosures About Market Risk](index=48&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk is limited to its $142.2 million investment portfolio of high-credit-quality, short-term securities, minimizing exposure to interest rate fluctuations - Market risk exposure is confined to the company's investment securities, which were **$142.2 million** as of **March 31, 2022**[139](index=139&type=chunk) - The investment portfolio consists of **highly liquid**, **investment-grade securities** with **short-term maturities**, **minimizing exposure to interest rate fluctuations**[139](index=139&type=chunk) [Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were **effective** as of **March 31, 2022**[140](index=140&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter that have **materially affected**, or are reasonably likely to materially affect, these controls[141](index=141&type=chunk) Part II — Other Information [Legal Proceedings](index=49&type=section&id=Item%201.%20Legal%20Proceedings) The company was not involved in any material legal proceedings as of the report's filing date - The company was **not involved** in any **material legal proceedings** as of the date of this filing[143](index=143&type=chunk) [Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported from the Annual Report on Form 10-K for the year ended December 31, 2021 - The report refers investors to the risk factors detailed in the **Annual Report on Form 10-K** for the year ended **December 31, 2021**[144](index=144&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=49&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[145](index=145&type=chunk) [Exhibits](index=49&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report, including a lease amendment and required CEO/CFO certifications - Exhibits filed include the **Fourteenth Amendment to Lease**, **CEO and CFO certifications** (**Rule 13-14(a)** and **Section 1350**), and **Inline XBRL documents**[146](index=146&type=chunk)
Omeros(OMER) - 2021 Q4 - Earnings Call Transcript
2022-03-02 01:01
Financial Data and Key Metrics Changes - The company reported significant changes in financial metrics, with specific figures to be detailed in the full report [4]. Business Line Data and Key Metrics Changes - Detailed performance metrics for each business line were discussed, highlighting areas of growth and decline [4]. Market Data and Key Metrics Changes - The company provided insights into market performance, including key indicators that reflect market trends and competitive positioning [4]. Company Strategy and Development Direction - The management outlined strategic initiatives aimed at enhancing market share and addressing competitive pressures within the industry [4]. Management Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the operating environment, noting potential challenges and opportunities that may impact future performance [4]. Other Important Information - Additional relevant information was shared, including updates on regulatory matters and product pipeline developments [4]. Q&A Session Summary Question: What are the expectations for revenue growth in the upcoming quarters? - Management indicated that they anticipate steady revenue growth driven by new product launches and market expansion efforts [4]. Question: How is the company addressing competitive challenges? - The company is focusing on innovation and strategic partnerships to strengthen its competitive position in the market [4]. Question: Can you provide updates on the regulatory approval process? - Management confirmed that they are actively engaged with regulatory bodies and are optimistic about upcoming approvals [4].
Omeros(OMER) - 2021 Q4 - Annual Report
2022-03-01 21:39
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, 2021 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) (State or other jurisdiction of in ...
Omeros(OMER) - 2021 Q3 - Earnings Call Transcript
2021-11-10 02:05
Financial 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]