Q1 2026 Omeros Corp Earnings Call

Speaker #1: Good afternoon and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in listen-only mode. After the company's remarks, we will conduct a question-and-answer session.

Operator: Good afternoon, and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in listen-only mode. After the company's remarks, we will conduct a question and answer session. If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press star nine to raise your hand and star six to unmute. Please be advised that this call is being recorded at the company's request and a replay will be available on the company's website. I will now turn the call over to Jennifer Cook Williams, investor relations for Omeros. Please go ahead.

Operator: Good afternoon, and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in listen-only mode. After the company's remarks, we will conduct a question and answer session. If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press star nine to raise your hand and star six to unmute. Please be advised that this call is being recorded at the company's request and a replay will be available on the company's website. I will now turn the call over to Jennifer Williams, investor relations for Omeros. Please go ahead.

Speaker #1: If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press star 9 to raise your hand and star 6 to unmute.

Speaker #1: Please be advised that this call is being recorded at the company's request and a replay will be available on the company's website. I'll now turn the call over to Jennifer Williams, investor relations for Omeros.

Speaker #1: Please go ahead.

Speaker #2: Thank you. And good afternoon, everyone. Before we begin, please note that today's discussion will include forward-looking statements. These statements reflect management's current expectations and beliefs as of today and are subject to risks and uncertainties that could cause actual results to differ materially.

Jennifer Cook Williams: Thank you, good afternoon, everyone. Before we begin, please note that today's discussion will include forward-looking statements. These statements reflect management's current expectations and beliefs as of today and are subject to risks and uncertainties that could cause actual results to differ materially. For a detailed discussion of these risks and uncertainties, please refer to the special note regarding forward-looking statements and the Risk Factors section in our quarterly report on form 10-Q filed today with the SEC, as well as our most recent annual report on form 10-K. Today's call will include a discussion of certain non-GAAP financial measures.

Jennifer Williams: Thank you, good afternoon, everyone. Before we begin, please note that today's discussion will include forward-looking statements. These statements reflect management's current expectations and beliefs as of today and are subject to risks and uncertainties that could cause actual results to differ materially. For a detailed discussion of these risks and uncertainties, please refer to the special note regarding forward-looking statements and the Risk Factors section in our quarterly report on Form 10-Q filed today with the SEC, as well as our most recent annual report on Form 10-K. Today's call will include a discussion of certain non-GAAP financial measures.

Speaker #2: For a detailed discussion of these risks and uncertainties, please refer to the special note regarding forward-looking statements and the risk report on Form 10Q filed today with the SEC, as well as our most recent annual report on Form 10K.

Speaker #2: Today's call will include a discussion of certain non-GAAP financial measures. A reconciliation of these non-GAAP measures to the corresponding GAAP measures is included within Omeros' earnings press release issued earlier today.

Jennifer Cook Williams: A reconciliation of these non-GAAP measures to the corresponding GAAP measures is included within Omeros' earnings press release issued earlier today, which is available on the investor relations page of our website and has been furnished with the form 8-K we filed with the SEC earlier today. With that, I'll turn the call over to Dr. Gregory A. Demopulos, Chairman and CEO of Omeros Corporation.

Jennifer Williams: A reconciliation of these non-GAAP measures to the corresponding GAAP measures is included within Omeros' earnings press release issued earlier today, which is available on the investor relations page of our website and has been furnished with the Form 8-K we filed with the SEC earlier today. With that, I'll turn the call over to Dr. Greg Demopulos, Chairman and CEO of Omeros Corporation.

Speaker #2: Which is available on the investor relations page of our website, and has been furnished with the Form 8K we filed with the SEC earlier today.

Speaker #2: With that, I'll turn the call over to Dr. Greg Demopulos, Chairman and CEO of Omeros.

Speaker #3: Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our chief accounting officer; Dr. Cathy Melphi, our chief regulatory officer; and Dr. Steve Whitaker, vice president of clinical.

Gregory A. Demopulos: Thank you, Jennifer. Good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer, Dr. Catherine A. Melfi, our Chief Regulatory Officer, and Dr. J. Steven Whitaker, Vice President, Clinical Development. I'll start with an overview of our Q1 2026 operations and financial results, followed by program updates. After that, David will cover the financials in more detail. We'll open the call for questions. We entered 2026 with two catalysts: the closing of our previously announced transaction with Novo Nordisk for zaltenibart, our lead investigational MASP-3 inhibitor, and the FDA approval of YARTEMLEA, our lead MASP-2 inhibitor for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA. This approval made YARTEMLEA the first and only approved treatment for this often fatal complication, and the first and only approved inhibitor of the lectin pathway of complement.

Greg Demopulos: Thank you, Jennifer. Good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer, Dr. Cathy Melfi, our Chief Regulatory Officer, and Dr. Steve Whitaker, Vice President, Clinical. I'll start with an overview of our Q1 2026 operations and financial results, followed by program updates. After that, David will cover the financials in more detail. We'll open the call for questions. We entered 2026 with two catalysts: the closing of our previously announced transaction with Novo Nordisk for zaltenibart, our lead investigational MASP-3 inhibitor, and the FDA approval of YARTEMLEA, our lead MASP-2 inhibitor for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA. This approval made YARTEMLEA the first and only approved treatment for this often fatal complication, and the first and only approved inhibitor of the lectin pathway of complement.

Speaker #3: I'll start with an overview of our first quarter 2026 operations and financial results, followed by program updates. After that, David will cover the financials in more detail, and then we'll open the call for questions.

Speaker #3: We entered 2026 with two catalysts: the closing of our previously announced transaction with Novo Nordisk for Zoltenebar, our lead investigational MASP-3 inhibitor, and the FDA approval of Yartemlia, our lead MASP-2 inhibitor.

Speaker #3: For the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA, TMA. This approval made Yartemlia the first and only approved treatment for this often fatal complication.

Speaker #3: And the first and only approved inhibitor of the lectin pathway of complement. We launched in January with initial shipments to distributors beginning mid-month, followed shortly by first sales.

Gregory A. Demopulos: We launched in January with initial shipments to distributors beginning mid-month, followed shortly by first sales. In Q1, YARTEMLEA gross revenues were $11.1 million, with net revenues of $9.9 million, reflecting gross to net adjustments of approximately 11%. Early demand and uptake are strong. YARTEMLEA became cash flow positive in Q1 despite a mid-January launch, and we expect it to drive company-wide positive cash flow within 18 months. Net income for Q1 was $56.1 million, or $0.78 per share, including a $73.1 million non-cash mark-to-market gain on the embedded derivative associated with our 2029 convertible notes. Excluding this non-cash item, net loss was $17.1 million or $0.24 per share.

Greg Demopulos: We launched in January with initial shipments to distributors beginning mid-month, followed shortly by first sales. In Q1, YARTEMLEA gross revenues were $11.1 million, with net revenues of $9.9 million, reflecting gross to net adjustments of approximately 11%. Early demand and uptake are strong. YARTEMLEA became cash flow positive in Q1 despite a mid-January launch, and we expect it to drive company-wide positive cash flow within 18 months. Net income for Q1 was $56.1 million, or $0.78 per share, including a $73.1 million non-cash mark-to-market gain on the embedded derivative associated with our 2029 convertible notes. Excluding this non-cash item, net loss was $17.1 million or $0.24 per share.

Speaker #3: In the first quarter, Yartemlia gross revenues were $11.1 million with net revenues of $9.9 million, reflecting gross to net adjustments of approximately $11%. Early demand and uptake are strong.

Speaker #3: Yartemlia became cash flow positive in the first quarter, despite a mid-January launch, and we expect it to drive company-wide positive cash flow within 18 months.

Speaker #3: Net income for the first quarter was $56.1 million, or $78 cents per share. Including a $73.1 million non-cash mark-to-market gain on the embedded derivative associated with our 2029 convertible notes.

Speaker #3: Excluding this non-cash item, adjusted net gross loss was, or net loss, was $17.1 million, or $24 cents per share. We ended the quarter with $135.3 million in cash and investments, after retiring our remaining 2026 convertible notes.

Gregory A. Demopulos: We ended the quarter with $135.3 million in cash and investments after retiring our remaining 2026 convertible notes. During Q1, we repurchased and retired approximately 360,000 shares of our common stock at an average price of $11.70 per share for a total of $4.2 million. We may continue to repurchase shares from time to time, subject to market conditions and other considerations. Our transaction with Novo Nordisk provided substantial non-dilutive capital to support our growth. At closing, we received $240 million in upfront cash, funding operations, including the YARTEMLEA launch. We are also eligible for another $100 million in near-term milestone payments from Novo.

Greg Demopulos: We ended the quarter with $135.3 million in cash and investments after retiring our remaining 2026 convertible notes. During Q1, we repurchased and retired approximately 360,000 shares of our common stock at an average price of $11.70 per share for a total of $4.2 million. We may continue to repurchase shares from time to time, subject to market conditions and other considerations. Our transaction with Novo Nordisk provided substantial non-dilutive capital to support our growth. At closing, we received $240 million in upfront cash, funding operations, including the YARTEMLEA launch. We are also eligible for another $100 million in near-term milestone payments from Novo.

Speaker #3: During the first quarter, we repurchased and retired approximately $360,000 shares of our common stock at an average price of $11.70 per share, for a total of $4.2 million.

Speaker #3: We may continue to repurchase shares from time to time subject to market conditions and other considerations. Our transaction with Novo Nordisk provided substantial non-dilutive capital to support our growth.

Speaker #3: At closing, we received $240 million in upfront cash, funding operations, including the Yartemlia launch. We are also eligible for another $100 million in near-term milestone payments from Novo.

Speaker #3: The deal is valued at up to $2.1 billion, in upfront and milestone payments, plus royalties in the high single-digit to high-teen range. Our early launch has been focused on four priorities.

Gregory A. Demopulos: The deal is valued at up to $2.1 billion in upfront and milestone payments, plus royalties in the high single-digit to high teen range. Our early launch has been focused on 4 priorities. First, educating transplant care teams to drive earlier recognition and treatment of TA-TMA. Second, securing rapid institutional access through Pharmacy and Therapeutics, or P&T, committee approvals and streamlined ordering. Third, ensuring consistent, timely reimbursement. Finally, demonstrating strong economic value through Health Economics and Outcomes Research, or HEOR. Execution is ahead of plan. Our field force is fully deployed, detailing all 175 transplant centers nationwide. By 31 March, 30 unique accounts had ordered YARTEMLEA, reflecting accelerated adoption. Despite the typical 6 to 9-month timeline for P&T committee approvals, accounts are moving faster than expected.

Greg Demopulos: The deal is valued at up to $2.1 billion in upfront and milestone payments, plus royalties in the high single-digit to high teen range. Our early launch has been focused on 4 priorities. First, educating transplant care teams to drive earlier recognition and treatment of TA-TMA. Second, securing rapid institutional access through Pharmacy and Therapeutics, or P&T, committee approvals and streamlined ordering. Third, ensuring consistent, timely reimbursement. Finally, demonstrating strong economic value through Health Economics and Outcomes Research, or HEOR. Execution is ahead of plan. Our field force is fully deployed, detailing all 175 transplant centers nationwide. By 31 March, 30 unique accounts had ordered YARTEMLEA, reflecting accelerated adoption. Despite the typical 6 to 9-month timeline for P&T committee approvals, accounts are moving faster than expected.

Speaker #3: First, educating transplant care teams to drive earlier recognition and treatment of TA, TMA. Second, securing rapid institutional access through pharmacy and therapeutics, or P&T, committee approvals and streamlined ordering.

Speaker #3: Third, ensuring consistent timely reimbursement. And finally, demonstrating strong economic value through health economics and outcomes research, or HEOR. Execution is ahead of plan. Our field force is fully deployed, detailing all 175 transplant centers nationwide.

Speaker #3: By March 31, 30 unique accounts had ordered Yartemlia, reflecting accelerated adoption. Despite the typical 6- to 9-month timeline for P&T committee approvals, accounts are moving faster than expected.

Speaker #3: By quarter end, we understand that 60% of the top 10 centers—40% of the top 20—38% of the top 40—and approximately 30% of the top 80 US centers had received P&T committee approval.

Gregory A. Demopulos: By quarter end, we understand that 60% of the top 10 centers, 40% of the top 20, 38% of the top 40, and approximately 30% of the top 80 US centers have received P&T committee approval. Looking at reimbursement, all prior authorization requests submitted to third-party commercial payers to date have been approved, and centers have begun receiving full payment. HEOR analyses which support the YARTEMLEA pricing and show compelling quality-of-life improvements are being finalized and prepared for publication. Early indicators, including strong receptivity from transplant centers, formulary momentum, and payer alignment with the label support our expectation that YARTEMLEA can become standard of care for TA-TMA. In April, the US Centers for Medicare & Medicaid Services, or CMS, assigned a permanent healthcare common procedure coding system J-code for YARTEMLEA.

Greg Demopulos: By quarter end, we understand that 60% of the top 10 centers, 40% of the top 20, 38% of the top 40, and approximately 30% of the top 80 US centers have received P&T committee approval. Looking at reimbursement, all prior authorization requests submitted to third-party commercial payers to date have been approved, and centers have begun receiving full payment. HEOR analyses which support the YARTEMLEA pricing and show compelling quality-of-life improvements are being finalized and prepared for publication. Early indicators, including strong receptivity from transplant centers, formulary momentum, and payer alignment with the label support our expectation that YARTEMLEA can become standard of care for TA-TMA. In April, the US Centers for Medicare & Medicaid Services, or CMS, assigned a permanent healthcare common procedure coding system J-code for YARTEMLEA.

Speaker #3: Looking at reimbursement, all prior authorization requests submitted to third-party commercial payers to date have been approved. And centers have begun receiving full payment. HEOR analyses, which support Yartemlia pricing, show compelling quality-of-life improvements are being finalized and prepared for publication.

Speaker #3: Early indicators, including strong receptivity from transplant centers, formulary momentum, and payer alignment with the label, support our expectation that Yartemlia can become standard of care for TA, TMA.

Speaker #3: In April, the US Centers for Medicare and Medicaid Services, or CMS, assigned a permanent healthcare common procedure coding system J code for Yartemlia. This simplifies billing and reimbursement across payers, reduces administrative burden, supports faster patient access, and improves reimbursement predictability.

Gregory A. Demopulos: This simplifies billing and reimbursement across payers, reduces administrative burden, supports faster patient access, and improves reimbursement predictability. The J-code becomes effective 1 July. In April, CMS, in its Inpatient Prospective Payment System Proposed Rule, recommended approval of the new Technology Add-on Payment, or NTAP, for YARTEMLEA. NTAP provides additional payments to hospitals for certain high-cost innovative technologies helping bridge the gap until standard payment systems incorporate them. The final rule is expected in August, with NTAP effective 1 October of this year. We remain focused on expansion opportunities for YARTEMLEA and our MASP-2 program. Beyond the US, our marketing authorization application for YARTEMLEA in TA-TMA is under review by the European Medicines Agency. We continue to expect a decision mid-year. We are evaluating potential partnerships, including broad ex-US and regional collaborations to support commercialization outside the US.

Greg Demopulos: This simplifies billing and reimbursement across payers, reduces administrative burden, supports faster patient access, and improves reimbursement predictability. The J-code becomes effective 1 July. In April, CMS, in its Inpatient Prospective Payment System Proposed Rule, recommended approval of the new Technology Add-on Payment, or NTAP, for YARTEMLEA. NTAP provides additional payments to hospitals for certain high-cost innovative technologies helping bridge the gap until standard payment systems incorporate them. The final rule is expected in August, with NTAP effective 1 October of this year. We remain focused on expansion opportunities for YARTEMLEA and our MASP-2 program. Beyond the US, our marketing authorization application for YARTEMLEA in TA-TMA is under review by the European Medicines Agency. We continue to expect a decision mid-year. We are evaluating potential partnerships, including broad ex-US and regional collaborations to support commercialization outside the US.

Speaker #3: The J code becomes effective July 1. Also in April, CMS in its inpatient prospective payment system proposed rule recommended approval of the new technology add-on payment, or NTAP, for Yartemlia.

Speaker #3: NTAP provides additional payments to hospitals for certain high-cost innovative technologies, helping bridge the gap until standard payment systems incorporate them. The final rule is expected in August, with NTAP effective October 1 of this year.

Speaker #3: We remain focused on expansion opportunities for Yartemlia and our MASP-2 program. Beyond the US, our marketing authorization application for Yartemlia in TA, TMA is under review by the European Medicines Agency.

Speaker #3: We continue to expect a decision mid-year. We are evaluating potential partnerships, including broad XUS and regional collaborations to support commercialization outside the US. Beyond TA, TMA, we're assessing opportunities to expand the Yartemlia label to other indications involving lectin pathway activation, including acute respiratory distress syndrome, or ARDS, sickle cell disease, acute kidney injury, solid organ transplant-related TMA, and delayed graft function.

Gregory A. Demopulos: Beyond TATMA, we're assessing opportunities to expand the YARTEMLEA label to other indications involving lectin pathway activation, including acute respiratory distress syndrome, or ARDS; sickle cell disease; acute kidney injury; solid organ transplant-related TMA; and delayed graft function. We're also broadening our MASP-2 inhibitor platform beyond YARTEMLEA, advancing both our phase II-ready long-acting MASP-2 antibody OMS1029 and our oral MASP-2 small molecule program. Both are well-suited for chronic indications, including membranous nephropathy, other renal diseases, and neurological disorders such as Parkinson's and Alzheimer's. We're finalizing the initial phase II indication for once-quarterly OMS1029. We're now also working to advance our small molecule program to IND-enabling studies targeting once-daily oral delivery. Let's now turn to development programs beyond our complement inhibitor franchise.

Greg Demopulos: Beyond TATMA, we're assessing opportunities to expand the YARTEMLEA label to other indications involving lectin pathway activation, including acute respiratory distress syndrome, or ARDS; sickle cell disease; acute kidney injury; solid organ transplant-related TMA; and delayed graft function. We're also broadening our MASP-2 inhibitor platform beyond YARTEMLEA, advancing both our phase II-ready long-acting MASP-2 antibody OMS1029 and our oral MASP-2 small molecule program. Both are well-suited for chronic indications, including membranous nephropathy, other renal diseases, and neurological disorders such as Parkinson's and Alzheimer's. We're finalizing the initial phase II indication for once-quarterly OMS1029. We're now also working to advance our small molecule program to IND-enabling studies targeting once-daily oral delivery. Let's now turn to development programs beyond our complement inhibitor franchise.

Speaker #3: We're also broadening our MASP-2 inhibitor platform beyond Yartemlia. Advancing both our phase 2-ready long-acting MASP-2 antibody OMS-1029 and our oral MASP-2 small molecule program.

Speaker #3: Both are well-suited for chronic indications including membranous nephropathy, other renal diseases, and neurological disorders such as Parkinson's and Alzheimer's. We're finalizing the initial phase 2 indication for once quarterly OMS-1029.

Speaker #3: We're now also working to advance our small-molecule program to IND-enabling studies, targeting once-daily oral delivery. Let's now turn to development programs beyond our complement inhibitor franchise.

Speaker #3: Our PD-7 inhibitor program evaluating OMS-527 for cocaine use disorder remains fully funded by a grant from the National Institute on Drug Abuse, or NIDA.

Gregory A. Demopulos: Our PDE7 inhibitor program evaluating OMS527 for cocaine use disorder remains fully funded by a grant from the National Institute on Drug Abuse, or NIDA. We successfully completed animal cocaine interaction studies supporting a scheduled inpatient human study evaluating OMS527 in cocaine users. Recently, together with NIDA representation, we met with FDA to discuss the agency's request for additional non-clinical information before starting the inpatient study. The meeting was productive, and we are working with FDA to streamline the path to initiate the inpatient clinical trial, which is targeted to start by year-end. Based on its mechanism of action and our extensive preclinical data, we believe that OMS527 could be effective across a wide range of addictions and compulsive disorders.

Greg Demopulos: Our PDE7 inhibitor program evaluating OMS527 for cocaine use disorder remains fully funded by a grant from the National Institute on Drug Abuse, or NIDA. We successfully completed animal cocaine interaction studies supporting a scheduled inpatient human study evaluating OMS527 in cocaine users. Recently, together with NIDA representation, we met with FDA to discuss the agency's request for additional non-clinical information before starting the inpatient study. The meeting was productive, and we are working with FDA to streamline the path to initiate the inpatient clinical trial, which is targeted to start by year-end. Based on its mechanism of action and our extensive preclinical data, we believe that OMS527 could be effective across a wide range of addictions and compulsive disorders.

Speaker #3: We successfully completed animal cocaine interaction studies supporting a scheduled inpatient human study evaluating OMS-527 in cocaine users. Recently, together with NIDA representation, we met with the FDA to discuss the agency's request for additional non-clinical information before starting the inpatient study.

Speaker #3: The meeting was productive, and we are working with FDA to streamline the path to initiate the inpatient clinical trial which is targeted to start by year-end.

Speaker #3: Based on its mechanism of action and our extensive preclinical data, we believe that OMS-527 could be effective across a wide range of addictions and compulsive disorders.

Speaker #3: Turning to our targeted complement activating therapy, or TCAT, platform, this represents a novel class of recombinant antibodies designed to target and directly kill pathogens including bacteria, fungi, viruses, and parasites.

Gregory A. Demopulos: Turning to our targeted complement activating therapy, or TCAT platform, this represents a novel class of recombinant antibodies designed to target and directly kill pathogens, including bacteria, fungi, viruses, and parasites. Our initial focus is on multidrug-resistant organisms or MDROs, one of the most critical unmet needs in medicine. Unlike marketed antimicrobials, TCAT is designed to kill pathogens regardless of resistance profile without promoting resistance. Data from our TCAT platform were recently featured in a podium presentation at the annual congress of the European Society of Clinical Microbiology and Infectious Diseases, the seminal manuscript describing our TCAT technology was accepted for publication in Science Translational Medicine. Last but not least, we're pleased with the continued progress of OncoTox-AML, the lead development program in our OncoTox oncology platform.

Greg Demopulos: Turning to our targeted complement activating therapy, or TCAT platform, this represents a novel class of recombinant antibodies designed to target and directly kill pathogens, including bacteria, fungi, viruses, and parasites. Our initial focus is on multidrug-resistant organisms or MDROs, one of the most critical unmet needs in medicine. Unlike marketed antimicrobials, TCAT is designed to kill pathogens regardless of resistance profile without promoting resistance. Data from our TCAT platform were recently featured in a podium presentation at the annual congress of the European Society of Clinical Microbiology and Infectious Diseases, the seminal manuscript describing our TCAT technology was accepted for publication in Science Translational Medicine. Last but not least, we're pleased with the continued progress of OncoTox-AML, the lead development program in our OncoTox oncology platform.

Speaker #3: Our initial focus is on multi-drug-resistant organisms, or MDROs, one of the most critical unmet needs in medicine. Unlike marketed antimicrobials, TCAT is designed to kill pathogens regardless of resistance profile, without promoting resistance.

Speaker #3: Data from our TCAT platform were recently featured in a podium presentation at the annual Congress of the European Society of Clinical Microbiology and Infectious Diseases.

Speaker #3: And the seminal manuscript describing our TCAT technology was accepted for publication in Science Translational Medicine. Last but not least, we're pleased with the continued progress of Oncotox AML, the lead development program in our Oncotox oncology platform.

Speaker #3: Oncotox AML is an engineered biologic agent designed to treat acute myeloid leukemia or AML, the most common and deadliest form of adult leukemia. In both human tumor-bearing animal and in vitro human AML cell line studies, Oncotox AML has consistently shown superior efficacy to current standard of care treatments.

Gregory A. Demopulos: OncoTox-AML is an engineered biologic agent designed to treat acute myeloid leukemia or AML, the most common and deadliest form of adult leukemia. In both human tumor-bearing animal and in vitro human AML cell line studies, OncoTox-AML has consistently shown superior efficacy to current standard of care treatments, even at very low doses and across mutations associated with AML, such as TP53 and FLT3, which have historically been difficult to treat. In a non-human primate study, a single course of OncoTox-AML demonstrated the desired pharmacologic response. A marked selective, reversible, and dose-related reduction in myeloid progenitor cells, the cells that can mutate and lead to AML by up to 99%. Safety was equally strong. The treatment was well-tolerated with no safety signal of concern. IND-enabling studies are underway, and we are preparing for a first-in-human trial targeted for late 2027.

Greg Demopulos: OncoTox-AML is an engineered biologic agent designed to treat acute myeloid leukemia or AML, the most common and deadliest form of adult leukemia. In both human tumor-bearing animal and in vitro human AML cell line studies, OncoTox-AML has consistently shown superior efficacy to current standard of care treatments, even at very low doses and across mutations associated with AML, such as TP53 and FLT3, which have historically been difficult to treat. In a non-human primate study, a single course of OncoTox-AML demonstrated the desired pharmacologic response. A marked selective, reversible, and dose-related reduction in myeloid progenitor cells, the cells that can mutate and lead to AML by up to 99%. Safety was equally strong. The treatment was well-tolerated with no safety signal of concern. IND-enabling studies are underway, and we are preparing for a first-in-human trial targeted for late 2027.

Speaker #3: Even at very low doses and across mutations associated with AML such as TP53 and FLIT3, which have historically been difficult to treat. In a non-human primate study, a single course of Oncotox AML demonstrated the desired pharmacologic response.

Speaker #3: A marked, selective, reversible, and dose-related reduction in myeloid progenitor cells—the cells that can mutate and lead to AML—by up to 99%. Safety was equally strong.

Speaker #3: The treatment was well tolerated with no safety signal of concern. IND-enabling studies are underway, and we are preparing for a first-in-human trial targeted for late 2027.

Speaker #3: So that concludes our financial corporate and development program update. I'll now turn the call over to David Borges, our chief accounting officer for a detailed discussion of our financial results.

Gregory A. Demopulos: That concludes our financial, corporate, and development program update. I'll now turn the call over to David Borges, our Chief Accounting Officer, for a detailed discussion of our financial results. David?

Greg Demopulos: That concludes our financial, corporate, and development program update. I'll now turn the call over to David Borges, our Chief Accounting Officer, for a detailed discussion of our financial results. David?

Speaker #3: David?

Speaker #1: Thanks, Greg. Net income for the first quarter of 2026 was $56.1 million, or $78 per share, compared to net income of $86.5 million, or $1.22 per share in the fourth quarter of 2025.

David Borges: Thanks, Greg. Net income for Q1 2026 was $56.1 million or $0.78 per share compared to net income of $86.5 million or $1.22 per share in Q4 2025. Q1 results include a $73.1 million non-cash gain related to the mark-to-market adjustment on the embedded derivative associated with our 2029 convertible notes. By comparison, Q4 results included a net gain of $237.6 million on the sale of zaltenibart to Novo Nordisk, partially offset by a $136 million non-cash loss related to mark-to-market adjustments on embedded derivatives associated with our 2029 convertible notes and term loan. A clearer view of the company's operating performance excludes the non-cash remeasurements of our embedded derivatives.

David Borges: Thanks, Greg. Net income for Q1 2026 was $56.1 million or $0.78 per share compared to net income of $86.5 million or $1.22 per share in Q4 2025. Q1 results include a $73.1 million non-cash gain related to the mark-to-market adjustment on the embedded derivative associated with our 2029 convertible notes. By comparison, Q4 results included a net gain of $237.6 million on the sale of zaltenibart to Novo Nordisk, partially offset by a $136 million non-cash loss related to mark-to-market adjustments on embedded derivatives associated with our 2029 convertible notes and term loan. A clearer view of the company's operating performance excludes the non-cash remeasurements of our embedded derivatives.

Speaker #1: First quarter results include a $73.1 million non-cash gain related to the mark-to-market adjustment on the embedded derivative associated with our 2029 convertible notes. By comparison, fourth quarter results included a net gain of $237.6 million on the sale of Xeltenabart to Novo Nordisk, partially offset by a $136 million non-cash loss related to mark-to-market adjustments on embedded derivatives associated with our 2029 convertible notes and term loan.

Speaker #1: A clearer view of the company's operating performance excludes the non-cash remeasurements of our embedded derivatives. Excluding the 73.1 million embedded derivative adjustment non-gap adjusted net loss for the first quarter of 2026 was 17.1 million, and non-gap adjusted net loss per share was 24 cents per share.

David Borges: Excluding the $73.1 million embedded derivative adjustment, non-GAAP adjusted net loss for Q1 2026 was $17.1 million and non-GAAP adjusted net loss per share was $0.24 per share. As of 31 March 2026, we had $135.3 million in cash and investments. This balance includes the repayment of the remaining $17.1 million principal on our 2026 notes at maturity in February 2026. Following that repayment, our only remaining debt is $70.8 million of principal outstanding on our unsecured 2029 convertible notes, which are due in June 2029.

David Borges: Excluding the $73.1 million embedded derivative adjustment, non-GAAP adjusted net loss for Q1 2026 was $17.1 million and non-GAAP adjusted net loss per share was $0.24 per share. As of 31 March 2026, we had $135.3 million in cash and investments. This balance includes the repayment of the remaining $17.1 million principal on our 2026 notes at maturity in February 2026. Following that repayment, our only remaining debt is $70.8 million of principal outstanding on our unsecured 2029 convertible notes, which are due in June 2029.

Speaker #1: As of March 31, 2026, we had 135.3 million in cash and investments. This balance includes the repayment of the remaining 17.1 million principal on our notes on our 2026 notes at maturity in February of 2026.

Speaker #1: Following that repayment, our only remaining debt is 70.8 million of principal outstanding on our unsecured 2029 convertible notes, which are due in June 2029.

Speaker #1: During the first quarter, we repurchased and retired approximately $360,000 shares of our common stock at an average price of $11.70 per share, for a total of $4.2 million.

David Borges: During Q1, we repurchased and retired approximately 360,000 shares of our common stock at an average price of $11.70 per share for a total of $4.2 million. As Greg mentioned, YARTEMLEA launched in mid-January 2026. Gross revenues for Q1 were $11.1 million, all from YARTEMLEA product sales, reflecting strong early demand following launch. Uptake was driven by prescriber adoption and increasing market penetration, and we continued to expand access and build awareness. Net revenues were $9.9 million, reflecting gross to net adjustments of approximately 11%. Gross to net adjustments were relatively modest and consisted of chargebacks and distribution fees.

David Borges: During Q1, we repurchased and retired approximately 360,000 shares of our common stock at an average price of $11.70 per share for a total of $4.2 million. As Greg mentioned, YARTEMLEA launched in mid-January 2026. Gross revenues for Q1 were $11.1 million, all from YARTEMLEA product sales, reflecting strong early demand following launch. Uptake was driven by prescriber adoption and increasing market penetration, and we continued to expand access and build awareness. Net revenues were $9.9 million, reflecting gross to net adjustments of approximately 11%. Gross to net adjustments were relatively modest and consisted of chargebacks and distribution fees.

Speaker #1: As Greg mentioned, the Artemlia launched in mid-January 2026. Gross revenues for the first quarter were $11.1 million, all from the Artemlia product sales reflecting strong early demand following launch.

Speaker #1: Uptake was driven by prescriber adoption and increasing market penetration and we continue to expand access and build awareness. Net revenues were $9.9 million, reflecting gross-to-net adjustments of approximately 11%.

Speaker #1: Gross-to-net adjustments were relatively modest and consisted of chargebacks and distribution fees. Costs and expenses from continuing operations for the first quarter before interest and other income were $27.3 million.

David Borges: Costs and expenses from continuing operations for Q1 before interest and other income were $27.3 million, a decrease of $1.8 million from Q4 2025. Concurrently with the closing of the sale of zaltenibart to Novo Nordisk, we entered into a transition services agreement to facilitate the transfer of the acquired assets and support the continued operation of relevant studies and program activities. Costs incurred by Omeros under the transition services agreement, including third-party expenses and internal full-time employee or FTE costs, are being reimbursed by Novo Nordisk. Interest expense in Q1 was $5.9 million. The primary components of interest expense include the DRI royalty obligation and interest on the 2029 convertible notes.

David Borges: Costs and expenses from continuing operations for Q1 before interest and other income were $27.3 million, a decrease of $1.8 million from Q4 2025. Concurrently with the closing of the sale of zaltenibart to Novo Nordisk, we entered into a transition services agreement to facilitate the transfer of the acquired assets and support the continued operation of relevant studies and program activities. Costs incurred by Omeros under the transition services agreement, including third-party expenses and internal full-time employee or FTE costs, are being reimbursed by Novo Nordisk. Interest expense in Q1 was $5.9 million. The primary components of interest expense include the DRI royalty obligation and interest on the 2029 convertible notes.

Speaker #1: A decrease of 1.8 million from the fourth quarter of 2025. Concurrently with the closing of the sale of Xeltenabart to Novo Nordisk, we entered into a transition services agreement to facilitate the transfer of the acquired assets and support the continued operation of relevant studies and program activities.

Speaker #1: Costs incurred by Omeros under the transition services agreement, including third-party expenses, and internal full-time employee or FTE cost, are being reimbursed by Novo Nordisk.

Speaker #1: Interest expense in the first quarter was $5.9 million. The primary components of interest expense include the DRI royalty obligation, and interest on the 2029 convertible notes.

Speaker #1: Excluding the DRI, the Midway royalty obligation, which represents pass-through interest from Rayner to DRI, and as no economic impact to us, and excluding non-cash amortization of debt issuance costs and discounts, contractual cash interest expense for the first quarter of 2026 was $1.8 million, compared to $3.2 million in the prior quarter.

David Borges: Excluding the DRI, the OMIDRIA royalty obligation, which represents passthrough interest from Rayner to DRI and has no economic impact to us, and excluding non-cash amortization of debt issuance costs and discounts, contractual cash interest expense for Q1 2026 was $1.8 million compared to $3.2 million in the prior quarter. The decrease was primarily due to the full repayment of our secured term loan in November 2025. Interest and other income totaled $1.5 million in Q1, up from $1.1 million in Q4 2025, primarily reflecting higher average cash balances. As previously mentioned, during Q1, we recorded a $73.1 million non-cash gain from mark-to-market adjustment on the embedded derivative related to our 2029 convertible notes.

David Borges: Excluding the DRI, the OMIDRIA royalty obligation, which represents passthrough interest from Rayner to DRI and has no economic impact to us, and excluding non-cash amortization of debt issuance costs and discounts, contractual cash interest expense for Q1 2026 was $1.8 million compared to $3.2 million in the prior quarter. The decrease was primarily due to the full repayment of our secured term loan in November 2025. Interest and other income totaled $1.5 million in Q1, up from $1.1 million in Q4 2025, primarily reflecting higher average cash balances. As previously mentioned, during Q1, we recorded a $73.1 million non-cash gain from mark-to-market adjustment on the embedded derivative related to our 2029 convertible notes.

Speaker #1: The decrease was primarily due to the full repayment of our secured term loan in November 2025. Interest and other income totaled $1.5 million in the first quarter.

Speaker #1: Up from $1.1 million in the fourth quarter of '25, primarily reflecting higher average cash balances. As previously mentioned, during the first quarter, we recorded a $73.1 million non-cash gain from a mark-to-market adjustment on the embedded derivative related to our 2029 convertible notes.

Speaker #1: The change in valuation was primarily driven by the decline in our stock price during the quarter. Which decreased from $17.18 per share at December 31, 2025, to $10.56 per share at March 31, 2026.

David Borges: The change in valuation was primarily driven by the decline in our stock price during the quarter, which decreased from $17.18 per share at 31 December 2025 to $10.56 per share at 31 March 2026. An increase in stock price in Q2 would similarly result in a non-cash loss during the quarter. Conversely, a decrease in our stock price during Q2 would result in a non-cash gain. This embedded derivative reflects certain features of the notes, including the conversion option and interest make-whole provision available to the note holders. Because the valuation of this derivative is influenced by our stock price and other market inputs, it can introduce significant volatility in our reported results from quarter to quarter. This adjustment is non-cash and does not affect our operating performance or liquidity.

David Borges: The change in valuation was primarily driven by the decline in our stock price during the quarter, which decreased from $17.18 per share at 31 December 2025 to $10.56 per share at 31 March 2026. An increase in stock price in Q2 would similarly result in a non-cash loss during the quarter. Conversely, a decrease in our stock price during Q2 would result in a non-cash gain. This embedded derivative reflects certain features of the notes, including the conversion option and interest make-whole provision available to the note holders. Because the valuation of this derivative is influenced by our stock price and other market inputs, it can introduce significant volatility in our reported results from quarter to quarter. This adjustment is non-cash and does not affect our operating performance or liquidity.

Speaker #1: An increase in stock price in the second quarter was similarly resolved in a non-cash loss during the quarter, conversely, a decrease in our stock price during the second quarter would result in a non-cash gain.

Speaker #1: This embedded derivative reflects certain features of the notes, including the conversion option and interest make-whole provision available to the noteholders. Because evaluation of this derivative is influenced by our stock price and other market inputs, it can introduce significant volatility in our reported results from quarter to quarter.

Speaker #1: This adjustment is non-cash and does not affect our operating performance or liquidity. Accordingly, we present non-GAAP adjusted net income and net loss to exclude the non-cash swings.

David Borges: Accordingly, we present non-GAAP adjusted net income and net loss to exclude the non-cash nature of these volatile swings. Income from discontinued operations in Q1 was $4.8 million, a decrease of $1.8 million from Q4, primarily reflecting lower than forecasted US-based OMIDRIA royalties. Because US-based OMIDRIA royalties are fully passed through to DRI, fluctuation in these payments do not affect our cash position. Let's look at our expected Q2 2026 results. We anticipate that overall operating expenses from continuing operations will be slightly higher compared to Q1 2026. Sales and marketing expenses are expected to increase, reflecting costs associated with building our commercial infrastructure, including marketing expenses and other commercial launch activities for YARTEMLEA. YARTEMLEA is in the early stages of launch, we are not providing revenue guidance at this time.

David Borges: Accordingly, we present non-GAAP adjusted net income and net loss to exclude the non-cash nature of these volatile swings. Income from discontinued operations in Q1 was $4.8 million, a decrease of $1.8 million from Q4, primarily reflecting lower than forecasted US-based OMIDRIA royalties. Because US-based OMIDRIA royalties are fully passed through to DRI, fluctuation in these payments do not affect our cash position. Let's look at our expected Q2 2026 results. We anticipate that overall operating expenses from continuing operations will be slightly higher compared to Q1 2026. Sales and marketing expenses are expected to increase, reflecting costs associated with building our commercial infrastructure, including marketing expenses and other commercial launch activities for YARTEMLEA. YARTEMLEA is in the early stages of launch, we are not providing revenue guidance at this time.

Speaker #1: Income from discontinued operations in the first quarter was $4.8 million, a decrease of 1.8 million from the fourth quarter. Primarily reflecting lower-than-forecasted U.S.-based Midway royalties.

Speaker #1: Because U.S.-based Midway royalties are fully pass-through to DRI, fluctuations in these payments do not affect our cash position. Now, let's look at our expected second quarter 2026 results.

Speaker #1: We anticipate that overall operating expenses from continuing operations will be slightly higher compared to the first quarter of '26. Sales and marketing expenses are expected to increase, reflecting costs associated with building our commercial infrastructure, including marketing expenses and other commercial launch activities for Artemlia.

Speaker #1: As the Artemlia is in the early stages of launch, we are not providing revenue guidance at this time. This is consistent with our approach following a new product launch while market access and physician adoption are still developing, and until we are able to estimate revenue with greater accuracy.

David Borges: This is consistent with our approach following a new product launch while market access and physician adoption are still developing, and until we are able to estimate revenue with greater accuracy. We remain focused on building physician awareness, expanding disease education, and ensuring continued timely reimbursement. Interest and other income are expected to be higher than in Q1. Interest expense is expected to be approximately $7.1 million, reflecting the reduction in our outstanding debt and excludes any potential non-cash adjustments related to the OMIDRIA royalty obligation. Income from discontinued operations is expected to be in the $5 to 6 million range, excluding any non-cash remeasurement adjustment related to the OMIDRIA contract royalty asset. Finally, as a reminder, our reported results will continue to reflect mark-to-market adjustments on the embedded derivative tied to our 2029 convertible notes.

David Borges: This is consistent with our approach following a new product launch while market access and physician adoption are still developing, and until we are able to estimate revenue with greater accuracy. We remain focused on building physician awareness, expanding disease education, and ensuring continued timely reimbursement. Interest and other income are expected to be higher than in Q1. Interest expense is expected to be approximately $7.1 million, reflecting the reduction in our outstanding debt and excludes any potential non-cash adjustments related to the OMIDRIA royalty obligation. Income from discontinued operations is expected to be in the $5 to 6 million range, excluding any non-cash remeasurement adjustment related to the OMIDRIA contract royalty asset. Finally, as a reminder, our reported results will continue to reflect mark-to-market adjustments on the embedded derivative tied to our 2029 convertible notes.

Speaker #1: We remain focused on building physician awareness, expanding disease education, and ensuring continued timely reimbursement. Interest and other income are expected to be higher than in the first quarter.

Speaker #1: Interest expense is expected to be approximately $7.1 million, reflecting the reduction in our outstanding debt and excludes any potential non-cash adjustments related to the Midway royalty obligation.

Speaker #1: Income from discontinued operations is expected to million range, excluding any non-cash remeasurement adjustment related to the Midway contract royalty asset. And finally, as a reminder, our reported results will continue to reflect mark-to-market adjustments on the embedded derivative tied to our 2029 convertible notes.

Speaker #1: These adjustments are non-cash, can be volatile, and are largely driven by changes in our stock price and other market inputs. As a result, we present non-GAAP adjusted net income and loss measures to provide additional visibility into our underlying operating performance.

David Borges: These adjustments are non-cash, can be volatile, and are largely driven by changes in our stock price and other market inputs. As a result, we present non-GAAP adjusted net income and loss measures to provide additional visibility into our underlying operating performance. With that, I turn the call back over to Greg.

David Borges: These adjustments are non-cash, can be volatile, and are largely driven by changes in our stock price and other market inputs. As a result, we present non-GAAP adjusted net income and loss measures to provide additional visibility into our underlying operating performance. With that, I turn the call back over to Greg.

Speaker #1: With that, turn the call back over to Greg.

Speaker #2: Thanks, David. Operator, please open the call to questions.

Gregory A. Demopulos: Thanks, David. Operator, please open the call to questions.

Greg Demopulos: Thanks, David. Operator, please open the call to questions.

Speaker #3: We will now begin the question and answer session. If you would like to ask a question, please raise your hand now. The raise hand button can be found in the center of the toolbar at the bottom of your screen on Zoom desktop and on the left side of the toolbar on Zoom mobile.

Operator: We will now begin the question and answer session. If you would like to ask a question, please raise your hand now. The raise hand button can be found in the center of the toolbar at the bottom of your screen on Zoom desktop, and on the left side of the toolbar on Zoom mobile. If you have dialed into today's call, please press star nine to raise your hand and star six to unmute. Please stand by while we compile the Q&A roster. Your first question comes from the line of Steve Brozak with WBB. Your line is open. Please go ahead.

Operator: We will now begin the question and answer session. If you would like to ask a question, please raise your hand now. The raise hand button can be found in the center of the toolbar at the bottom of your screen on Zoom desktop, and on the left side of the toolbar on Zoom mobile. If you have dialed into today's call, please press star nine to raise your hand and star six to unmute. Please stand by while we compile the Q&A roster. Your first question comes from the line of Steve Brozak with WBB. Your line is open. Please go ahead.

Speaker #3: If you have dialed into today's call, please press star 9 to raise your hand and star 6 to unmute. Please stand by while we compile the Q&A roster.

Speaker #3: Your first question comes from the line of Steve Brozak with WBB. Your line is open. Please go ahead.

Speaker #4: Yeah, hi. Thanks for taking the question. I'd like to go into some granularity on your Temlia. First question has to deal with, from the time the clinician requests drug to the time you get it, can you detail how long it you get it to the hospital?

Steve Brozak: Yeah. Hi. Thanks for taking the question. I'd like to go into some granularity on YARTEMLEA. First question has to deal with from the time the clinician request drug to the time you get it, can you detail how long it you get it to the hospital? Can you detail us how long it takes and the process, please?

Steve Brozak: Yeah. Hi. Thanks for taking the question. I'd like to go into some granularity on YARTEMLEA. First question has to deal with from the time the clinician request drug to the time you get it, can you detail how long it you get it to the hospital? Can you detail us how long it takes and the process, please?

Speaker #4: Can you detail for us how long it takes and the process, please?

Speaker #2: Sure. Thanks, Steve. The distributors deliver drug to the sites within about 24 hours of receipt of the request. So the process is pretty straightforward.

Gregory A. Demopulos: Sure. Thanks, Steve. The distributors deliver drug to the sites within about 24 hours of receipt of the request.

Greg Demopulos: Sure. Thanks, Steve. The distributors deliver drug to the sites within about 24 hours of receipt of the request.

Steve Brozak: Okay.

Steve Brozak: Okay.

Gregory A. Demopulos: The process is pretty straightforward. The request is made to the distributors. Distributors deliver within 24 hours.

Greg Demopulos: The process is pretty straightforward. The request is made to the distributors. Distributors deliver within 24 hours.

Speaker #2: The request is made to the distributors. Distributors deliver within 24 hours.

Speaker #4: Okay. And can you give us some detail on because typically, on stem cell TATMA, on the transplant side, you're looking at about roughly 15% of the population are peds.

Steve Brozak: Okay. Can you give us some detail on, is typically on stem cell TA-TMA, on the transplant side, you're looking at about roughly 15% of the population are peds. How does that reflect in terms of what you've seen so far on the requests for YARTEMLEA, please?

Steve Brozak: Okay. Can you give us some detail on, is typically on stem cell TA-TMA, on the transplant side, you're looking at about roughly 15% of the population are peds. How does that reflect in terms of what you've seen so far on the requests for YARTEMLEA, please?

Speaker #4: How does that reflect in terms of what you've seen so far on the requests for your Temlia, please?

Speaker #2: Right. And you’re correct about that. The split between adult and pediatric patients in TATMA is roughly 85-15, as you noted. We only have, again, through the first quarter, a little over two months of data.

Gregory A. Demopulos: Right. You're correct about that. The split between adult and pediatric patients in TA-TMA is roughly 85/15, as you noted. We only have, again, through Q1, a little over 2 months of data, these data may be skewed. We are seeing a greater percentage of these patients being pediatric than the 15% that you cited. It appears that we're having really rapid adoption across both adult and pediatric patients.

Greg Demopulos: Right. You're correct about that. The split between adult and pediatric patients in TA-TMA is roughly 85/15, as you noted. We only have, again, through Q1, a little over 2 months of data, these data may be skewed. We are seeing a greater percentage of these patients being pediatric than the 15% that you cited. It appears that we're having really rapid adoption across both adult and pediatric patients.

Speaker #2: So, these data may be skewed, but we are seeing a greater percentage of these patients being pediatric than the 15% that you cited. So it appears that we're having really rapid adoption across both adult and pediatric patients.

Speaker #4: Okay. Now, I don't want to put words in your mouth, but typically, you would see the pediatric hematological oncologist being the most conservative so you're saying that they are asking for your Temlia in a greater number than the distribution.

Steve Brozak: Okay. Now, I don't wanna put words in your mouth, but typically you would see the pediatric hematological oncologist being the most conservative. You're saying that they are asking for YARTEMLEA in a greater number than the distribution. I Look, I know it's only a partial quarter, but so far you're seeing a trend that these more conservative prescribers are asking for drug at a greater rate than you would expect. Is that what I'm hearing?

Steve Brozak: Okay. Now, I don't wanna put words in your mouth, but typically you would see the pediatric hematological oncologist being the most conservative. You're saying that they are asking for YARTEMLEA in a greater number than the distribution. I Look, I know it's only a partial quarter, but so far you're seeing a trend that these more conservative prescribers are asking for drug at a greater rate than you would expect. Is that what I'm hearing?

Speaker #4: And look, I know it's only a partial quarter. But so far, you're seeing a trend that these more conservative prescribers are asking for drug at a greater rate than you would expect.

Speaker #4: Is that what I'm hearing?

Speaker #2: Well, I'm not sure that a point would create a trend. But what we're seeing is what I said, which is that there is a larger percentage of pediatric transplanters.

Gregory A. Demopulos: Well, I'm not sure that a point would create a trend. What we're seeing is what I said, which is that there is a larger percentage of pediatric transplanters than is represented by the overall split in TA-TMA between adults and pediatrics. We are seeing those pediatric transplanters requesting narsoplimab or YARTEMLEA.

Greg Demopulos: Well, I'm not sure that a point would create a trend. What we're seeing is what I said, which is that there is a larger percentage of pediatric transplanters than is represented by the overall split in TA-TMA between adults and pediatrics. We are seeing those pediatric transplanters requesting narsoplimab or YARTEMLEA.

Speaker #2: Than is represented by the overall split in TATMA between adults and pediatrics we are seeing those pediatric transplanters requesting. Narceplamab or Yartemlia.

Speaker #4: Okay, thanks. I thought I was the only person that was mixing Narceplamab and Yartemlia. You might have stated this earlier, but out of how many facilities out of the total targeted have you started to get prescribing or get requests from so far?

Steve Brozak: Okay. Thanks. I thought I was the only person that was mixing narsoplimab and YARTEMLEA. You might have stated this earlier, but out of how many facilities out of the total targeted have you started to get prescribing or get requests from so far?

Steve Brozak: Okay. Thanks. I thought I was the only person that was mixing narsoplimab and YARTEMLEA. You might have stated this earlier, but out of how many facilities out of the total targeted have you started to get prescribing or get requests from so far?

Speaker #2: We have, at the end of March—so by March 31—we had 30 separate accounts requesting Yartemlia.

Gregory A. Demopulos: We have at the end of March, so by 31 March, we had 30 separate accounts requesting YARTEMLEA.

Greg Demopulos: We have at the end of March, so by 31 March, we had 30 separate accounts requesting YARTEMLEA.

Speaker #4: And.

Steve Brozak: And-

Steve Brozak: And-

Speaker #2: Of that 30, let me just give you a little more color just we went through this in the prepared comments, but we were speaking there in percentages.

Gregory A. Demopulos: Of that 30, let me just give you a little more color. Just we went through this in the prepared comments, but we were speaking there in percentages. I think if I put it in absolute numbers, it may be helpful.

Greg Demopulos: Of that 30, let me just give you a little more color. Just we went through this in the prepared comments, but we were speaking there in percentages. I think if I put it in absolute numbers, it may be helpful.

Speaker #2: So I think if I put it in absolute numbers, it may be helpful to yeah, may be helpful to everyone. Of the top 10, 6 of the top 10 sites had ordered by March 31, 24 of the top 80 centers had ordered by March 31.

Steve Brozak: Yeah.

Steve Brozak: Yeah.

Gregory A. Demopulos: May be helpful to everyone. Of the top 10, six of the top 10 sites had ordered by 31 March. 24 of the top 80 centers had ordered by 31 March.

Greg Demopulos: May be helpful to everyone. Of the top 10, six of the top 10 sites had ordered by 31 March. 24 of the top 80 centers had ordered by 31 March.

Speaker #4: Okay. Okay. Last question. I'll get back into the queue. What kind of feedback, even if it's anecdotal, you're getting from the hematological oncologist and prescribing or anyone else on the clinician side?

Steve Brozak: Okay. Okay. Last question, I'll get back in the queue. What kind of feedback, even if it's anecdotal, are you getting from the hematological oncologists in prescribing or anyone else on the clinician side? Thank you. I'll jump back in the queue.

Steve Brozak: Okay. Okay. Last question, I'll get back in the queue. What kind of feedback, even if it's anecdotal, are you getting from the hematological oncologists in prescribing or anyone else on the clinician side? Thank you. I'll jump back in the queue.

Speaker #4: Thank you all. Jump back in the queue.

Speaker #2: Sure. Again, it's early. But the feedback that we have received has been effectively uniformly positive. I think that the results that are being seen with Yartemlia are impressive.

Gregory A. Demopulos: Sure. Again, it's early, the feedback that we have received has been effectively uniformly positive. I think that the results that are being seen with YARTEMLEA are impressive. Again, we're early in the launch, as I said, all signs look very encouraging. We do expect that YARTEMLEA will become standard of care for the treatment of TA-TMA.

Greg Demopulos: Sure. Again, it's early, the feedback that we have received has been effectively uniformly positive. I think that the results that are being seen with YARTEMLEA are impressive. Again, we're early in the launch, as I said, all signs look very encouraging. We do expect that YARTEMLEA will become standard of care for the treatment of TA-TMA.

Speaker #2: And again, we're early in the launch, but as I said, all signs look very encouraging, and we do expect that Yartemlia will become standard of care for the treatment of TATMA.

Speaker #4: Great. Well, thank you for the granularity. And I'm looking forward to the next call to see the trend after one point. How's that?

Steve Brozak: Great. Well, thank you for the granularity, and I'm looking forward to the next call to see the trend after 1 point. How's that?

Steve Brozak: Great. Well, thank you for the granularity, and I'm looking forward to the next call to see the trend after 1 point. How's that?

Gregory A. Demopulos: Very good. Thanks. Yep, we look forward to that as well.

Greg Demopulos: Very good. Thanks. Yep, we look forward to that as well.

Speaker #2: forward to that as well.

Speaker #5: Your next question comes from the line of Olivia Saunders with Cantor. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Olivia Brayer with Cantor. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Olivia Brayer with Cantor. Your line is open. Please go ahead.

Speaker #6: Hi. Good afternoon, guys. And thank you for the question. I know it's early, but Greg, how are you thinking about the split between inventory versus US wholesaler sales versus hospital demand?

Olivia Brayer: Hi. Good afternoon, guys, and thank you for the question. I know it's early, but Greg, how are you thinking about the split between inventory versus US wholesaler sales versus hospital demand, and how that might play out over the course of the year, just in terms of how we should think about the proportion of reported sales? Any comments on how many patients are actually on drug as of today?

Olivia Saunders: Hi. Good afternoon, guys, and thank you for the question. I know it's early, but Greg, how are you thinking about the split between inventory versus US wholesaler sales versus hospital demand, and how that might play out over the course of the year, just in terms of how we should think about the proportion of reported sales? Any comments on how many patients are actually on drug as of today?

Speaker #6: And how that might play out over the course of the year, just in terms of how we should think about the proportion of reported sales?

Speaker #6: And any comments on how many patients are actually on drug as of today?

Speaker #2: Sorry, I lost the second question, Olivia. What was that? It was a little muted on my end, maybe.

Gregory A. Demopulos: Sorry, I lost the second question. Olivia, what was that?

Greg Demopulos: Sorry, I lost the second question. Olivia, what was that?

Olivia Brayer: Yes

Olivia Saunders: Yes

Gregory A. Demopulos: muted on my end maybe.

Greg Demopulos: muted on my end maybe.

Speaker #6: Yeah. It was just a question about how many patients are actually on drug as of today. That are being treated with Yartemlia.

Olivia Brayer: Yeah, it was just a question about how many patients are actually on drug as of today?

Olivia Saunders: Yeah, it was just a question about how many patients are actually on drug as of today?

Gregory A. Demopulos: Sure

Greg Demopulos: Sure

Olivia Brayer: that are being treated with YARTEMLEA.

Olivia Saunders: that are being treated with YARTEMLEA.

Speaker #2: Sure. First of all, with respect to inventory, given the short delivery process, which as I explained in the last response, is 24 hours, the amount of inventory carried at the distributors and certainly at the centers is relatively small.

Gregory A. Demopulos: Sure. First of all, with respect to inventory, given the short delivery process, which as I explained in the last response is 24 hours, the amount of inventory carried at the distributors and certainly at the centers is relatively small. On the distributor side, we're seeing 1.5 weeks of inventory on average across those distributors. I think your next question was the number of patients on drug. That's a difficult number to provide because often the centers don't share the specific information about the number of patients or the type of patients or really any patient-specific information. Really what we see is how many vials are going into a center and from which center those vials are being requested. I'm not trying to dodge the question.

Greg Demopulos: Sure. First of all, with respect to inventory, given the short delivery process, which as I explained in the last response is 24 hours, the amount of inventory carried at the distributors and certainly at the centers is relatively small. On the distributor side, we're seeing 1.5 weeks of inventory on average across those distributors. I think your next question was the number of patients on drug. That's a difficult number to provide because often the centers don't share the specific information about the number of patients or the type of patients or really any patient-specific information. Really what we see is how many vials are going into a center and from which center those vials are being requested. I'm not trying to dodge the question.

Speaker #2: So on the distributor side, we're seeing one, one and a half weeks of inventory. On average, across those distributors, I think your next question was the number of patients on drug.

Speaker #2: That's a difficult number to provide. Because often the centers don't share the specific information about the number of patients or the type of patients or really any patient-specific information.

Speaker #2: So really, what we see is how many vials are going into a center and from which center those vials are being requested. So that is, I'm not trying to dodge the question.

Speaker #2: I'm trying to give you the best information we have. But we expect that it is a larger number of patients, obviously, than the number of accounts.

Gregory A. Demopulos: I'm trying to give you the best information we have. We expect that it is a larger number of patients obviously than the number of accounts. With respect to specific number, we just don't have that information.

Greg Demopulos: I'm trying to give you the best information we have. We expect that it is a larger number of patients obviously than the number of accounts. With respect to specific number, we just don't have that information.

Speaker #2: But with respect to a specific number, we just don't have that information.

Speaker #6: Okay. Fair enough. And can I ask, how are you thinking about the AstraZeneca/Oltimera Phase 3 study that they're running in TMA? I think they're using disease relapse as an endpoint, and it is a randomized study.

Olivia Brayer: Okay. Fair enough. Can I ask, how are you thinking about the AstraZeneca ULTOMIRIS phase III study that they're running in TMA? I think they're using disease relapse as an endpoint, and it is a randomized study. I'm just curious if you have any thoughts on how that might fit into the landscape.

Olivia Saunders: Okay. Fair enough. Can I ask, how are you thinking about the AstraZeneca ULTOMIRIS phase III study that they're running in TMA? I think they're using disease relapse as an endpoint, and it is a randomized study. I'm just curious if you have any thoughts on how that might fit into the landscape.

Speaker #6: So I'm just curious if you have any thoughts on how that might fit into the landscape.

Speaker #2: Right. Well, I understand that they've changed their endpoint. Their initial endpoint, as I understand it, and again, I want to caveat that this is my understanding.

Gregory A. Demopulos: Right. Well, I understand that they've changed their endpoint. Their initial endpoint, as I understand it, and again, I wanna caveat that, this is my understanding. The initial endpoint, as I understand it, was response. Following the readout of their pediatric open label trial, which used response as the endpoint, that response was not clearly what AstraZeneca had hoped to see. I think it had a 17% response rate. I know that subsequently, or as I understand it, subsequently, they revised the endpoint for their adult trial from response to survival. I don't know if they're looking at relapse. Our understanding is that the patients in that controlled adult trial, by definition, would really, our expectation would be need to be less severe than the patients we treated.

Greg Demopulos: Right. Well, I understand that they've changed their endpoint. Their initial endpoint, as I understand it, and again, I wanna caveat that, this is my understanding. The initial endpoint, as I understand it, was response. Following the readout of their pediatric open label trial, which used response as the endpoint, that response was not clearly what AstraZeneca had hoped to see. I think it had a 17% response rate. I know that subsequently, or as I understand it, subsequently, they revised the endpoint for their adult trial from response to survival. I don't know if they're looking at relapse. Our understanding is that the patients in that controlled adult trial, by definition, would really, our expectation would be need to be less severe than the patients we treated.

Speaker #2: But the initial endpoint, as I understand it, was response. But following the readout of their pediatric open-label trial, which used response as the endpoint, that response was not clearly what AstraZeneca had hoped to see.

Speaker #2: I think it had a 17% response rate. So I know that subsequently, or as I understand it, subsequently, they revised the endpoint for their adult trial from response to survival.

Speaker #2: I don't know if they're looking at relapse. Our understanding is that the patients in that controlled adult trial, by definition, would really—our expectation would be—need to be less severe than the patients we treated.

Gregory A. Demopulos: By virtue of the fact that in the patients we treated, running a controlled trial would really not be possible. I think there's a difference in the severity of the patients. Don't know if they're looking at relapse. I'll open the question up to Steve and/or Kathy if you have any other information about AstraZeneca and their data.

Speaker #2: By virtue of the fact that, in the patients we treated, running a controlled trial would really not be possible. So I think there's a difference in the severity of the patients.

Greg Demopulos: By virtue of the fact that in the patients we treated, running a controlled trial would really not be possible. I think there's a difference in the severity of the patients. Don't know if they're looking at relapse. I'll open the question up to Steve and/or Kathy if you have any other information about AstraZeneca and their data.

Speaker #2: Don't know if they're looking at relapse all open. The question up to Steve, and/or Kathy, if you have any other information about AstraZeneca and their data.

J. Steven Whitaker: Hi, Greg. This is Steve. We only know what's on ClinicalTrials.gov at this point, and the primary endpoint is event-free survival, and that is death or clinical worsening. It's not really relapse, as Greg said. It'd be worsening from their baseline condition. They do look at duration of response and the relapse, but those are lower secondary endpoints. Obviously, I don't have the protocol, so I don't know how these were ranked hierarchically, but those are pretty far down the line. If that helps.

Steve Whitaker: Hi, Greg. This is Steve. We only know what's on ClinicalTrials.gov at this point, and the primary endpoint is event-free survival, and that is death or clinical worsening. It's not really relapse, as Greg said. It'd be worsening from their baseline condition. They do look at duration of response and the relapse, but those are lower secondary endpoints. Obviously, I don't have the protocol, so I don't know how these were ranked hierarchically, but those are pretty far down the line. If that helps.

Speaker #4: Hi, Greg. This is Steve. We only know what's on clinicaltrials.gov. At this point, the primary endpoint is event-free survival. And that is death or clinical worsening.

Speaker #4: So it's not really relapse, as Greg said. It would be worsening from their baseline condition. They do look at duration of response and relapse, but those are lower secondary endpoints.

Speaker #4: And I obviously—I don't have the protocol, so I don't know how these were ranked hierarchically. But those are pretty far down the line.

Speaker #4: If that helps.

Speaker #6: Yep. That's great. Thank you, guys. Appreciate it.

Olivia Brayer: Yep. That's great. Thank you, guys. Appreciate it.

Olivia Saunders: Yep. That's great. Thank you, guys. Appreciate it.

Speaker #2: Yeah. Thank you. Olivia, I think also that there have been a number of recent publications and data presentations around the increased infection rates and increased infection-related mortality with C5 inhibition.

Gregory A. Demopulos: Yeah. Thank you, Olivia. I think also that there have been a number of recent publications and data presentations around the increased infection rates and increased infection-related mortality with C5 inhibition. I know coming out of an adult study at MSK, Memorial Sloan Kettering, a pediatric study out of Children's Healthcare of Atlanta associated with Emory. I understand that there also has been additional data generated and presented by Dana-Farber and Boston Children's, again, in the pediatric center. All of those data align quite nicely with each other. Those might be something that would help you as well.

Greg Demopulos: Yeah. Thank you, Olivia. I think also that there have been a number of recent publications and data presentations around the increased infection rates and increased infection-related mortality with C5 inhibition. I know coming out of an adult study at MSK, Memorial Sloan Kettering, a pediatric study out of Children's Healthcare of Atlanta associated with Emory. I understand that there also has been additional data generated and presented by Dana-Farber and Boston Children's, again, in the pediatric center. All of those data align quite nicely with each other. Those might be something that would help you as well.

Speaker #2: I know, coming out of an adult study at MSK, Memorial Sloan Kettering, a pediatric study out of Children's Hospital in Atlanta, associated with Emory, and I understand that there also has been additional data generated and presented by Dana-Farber and Boston Children's, again, in the pediatric center—all of those data align quite nicely with each other.

Speaker #2: So those might be something that would help you as well.

Speaker #6: And Greg, you had mentioned the change in the endpoint, and I did confirm that on ClinicalTrials.gov your understanding was correct. It had been response.

Catherine A. Melfi: Greg, you had mentioned the change in the endpoint, and I did confirm that on ClinicalTrials.gov. Your understanding was correct. It had been response, and currently it's, as Steve said, event-free survival.

Cathy Melfi: Greg, you had mentioned the change in the endpoint, and I did confirm that on ClinicalTrials.gov. Your understanding was correct. It had been response, and currently it's, as Steve said, event-free survival.

Speaker #6: And currently, it's, as Steve said, event-free survival.

Speaker #2: So thank you, Kathy. So yes. So they had changed from response to survival. Okay. Anything else? Olivia?

Gregory A. Demopulos: Thank you, Kathy. Yes, they had changed from response to survival. Okay. Anything else, Olivia?

Greg Demopulos: Thank you, Kathy. Yes, they had changed from response to survival. Okay. Anything else, Olivia?

Speaker #6: Nope, that's perfect. Thank you, guys. Appreciate the follow-up.

Olivia Brayer: Nope. That's perfect. Thank you, guys.

Olivia Saunders: Nope. That's perfect. Thank you, guys.

Gregory A. Demopulos: Great.

Greg Demopulos: Great.

Olivia Brayer: Appreciate the follow-up.

Olivia Saunders: Appreciate the follow-up.

Gregory A. Demopulos: Thank you very much.

Greg Demopulos: Thank you very much.

Speaker #2: Thank you very much.

Speaker #1: Your next question comes from the line of Brandon Foulkes with HC Wainwright. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Brandon Folkes with H.C. Wainwright & Co. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Brandon Folkes with H.C. Wainwright & Co. Your line is open. Please go ahead.

Speaker #7: Hi. Thanks for taking my questions, and congrats on all the progress. Maybe just one from me, Greg. I think I heard you say you're working on efforts to recognize TMA earlier.

Brandon Folkes: Hi. Thanks for taking my questions, and congrats on all the progress. Maybe just one for me, Greg. I think I heard you say, you're working on efforts to recognize TMA earlier. Can you just elaborate on those efforts and, you know, whether you believe once NTAP comes into practice, you know, that may facilitate less friction to earlier intervention, or what do you think drives earlier intervention? Thank you.

Brandon Folkes: Hi. Thanks for taking my questions, and congrats on all the progress. Maybe just one for me, Greg. I think I heard you say, you're working on efforts to recognize TMA earlier. Can you just elaborate on those efforts and, you know, whether you believe once NTAP comes into practice, you know, that may facilitate less friction to earlier intervention, or what do you think drives earlier intervention? Thank you.

Speaker #7: Can you just elaborate on those efforts and whether you believe once NTAP comes into practice, that may facilitate less friction to earlier intervention? Or what do you think drives earlier intervention?

Speaker #7: Thank you.

Speaker #2: Hi, Brandon. Thank you. Certainly, we're interested in earlier intervention. We want to save as many patients as possible. Our expectation and the data support that the earlier one jumps on this problem the greater the likelihood of success in outcome.

Gregory A. Demopulos: Hi, Brandon. Thank you. Certainly, we're interested in earlier intervention. We want to save as many patients as possible. Our expectation and the data support that the earlier one jumps on this problem, the greater the likelihood of success in outcome. I think that there certainly seems to be an increasing awareness of that within the transplant community. We are receiving incoming questions about the temporal, the temporally upstream administration of YARTEMLEA. All of that I think bodes well for patients. With respect to will the NTAP assist that? Yes. The NTAP increases the subsidization, so actually subsidizes in good part for Medicare patients, the payment on the inpatient side. That's where you would expect that earliest treatment to begin.

Greg Demopulos: Hi, Brandon. Thank you. Certainly, we're interested in earlier intervention. We want to save as many patients as possible. Our expectation and the data support that the earlier one jumps on this problem, the greater the likelihood of success in outcome. I think that there certainly seems to be an increasing awareness of that within the transplant community. We are receiving incoming questions about the temporal, the temporally upstream administration of YARTEMLEA. All of that I think bodes well for patients. With respect to will the NTAP assist that? Yes. The NTAP increases the subsidization, so actually subsidizes in good part for Medicare patients, the payment on the inpatient side. That's where you would expect that earliest treatment to begin.

Speaker #2: So I think that there certainly seems to be an increasing awareness of that within the transplant community. We are receiving incoming questions about the temporal upstream administration of Yartemlia. All of that, I think, bodes well for patients.

Speaker #2: With respect to will the NTAP assist that? Yes. The NTAP increases the subsidization. So actually, subsidizes in good part for Medicare patients. The payment on the inpatient side and that's where you would expect that earliest treatment to begin.

Speaker #2: So, I think your thought around whether the NTAP would help in that respect, I think, is insightful. So, we're waiting to see. But we do expect that there will be an increasing move to earlier treatment.

Gregory A. Demopulos: I think your thought around whether the NTAP would help in that respect, I think is insightful. We're waiting to see, but we do expect that there will be an increasing move to earlier treatment, particularly given that initially, a good number of the patients we were treating were eculizumab failures. We were really catching patients and in the Q1, catching patients who were falling knives. Yet those patients, very many of them responded very well to Narsoplimab or to YARTEMLEA. I think that there will, there's a greater understanding and increasing awareness of moving temporally upstream in the administration process. I think that's a good thing. I think it's good for patients. Does that help? Okay.

Greg Demopulos: I think your thought around whether the NTAP would help in that respect, I think is insightful. We're waiting to see, but we do expect that there will be an increasing move to earlier treatment, particularly given that initially, a good number of the patients we were treating were eculizumab failures. We were really catching patients and in the Q1, catching patients who were falling knives. Yet those patients, very many of them responded very well to Narsoplimab or to YARTEMLEA. I think that there will, there's a greater understanding and increasing awareness of moving temporally upstream in the administration process. I think that's a good thing. I think it's good for patients. Does that help? Okay.

Speaker #2: Particularly given that initially, a good number of the patients we were treating were eculizumab failures. So we were really catching patients in the first quarter, catching patients who were falling knives.

Speaker #2: And yet those patients very many of them responded very well to nursing supplement or to Yartemlia. So I think that there will there's a greater understanding and increasing awareness of moving temporally upstream in the administration process.

Speaker #2: I think that's a good thing. I think it's good for patients. Does that help? Okay.

Speaker #7: It does. Thanks so much, Greg. Sorry.

Brandon Folkes: It does. Thanks so much, Greg. Sorry.

Brandon Folkes: It does. Thanks so much, Greg. Sorry.

Speaker #2: Okay. Thanks, Brandon.

Gregory A. Demopulos: Okay. Thanks, Brandon.

Greg Demopulos: Okay. Thanks, Brandon.

Speaker #7: Sorry, just dealing with the mute button.

Brandon Folkes: Sorry. Just dealing with the mute button.

Brandon Folkes: Sorry. Just dealing with the mute button.

Speaker #2: Nope, that's fine. Any other questions?

Gregory A. Demopulos: No, that's fine. Any other questions?

Greg Demopulos: No, that's fine. Any other questions?

Speaker #1: Your next question comes from the line of Serge Bellinger with Needham. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Serge Belanger with Needham. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Serge Belanger with Needham. Your line is open. Please go ahead.

Speaker #8: Hi. Good afternoon. Thanks for taking my questions. I guess a few on just to get it a little more granularity on the 1-2 sales number.

Serge Belanger: Hi. Good afternoon. Thanks for taking my questions. I guess a few on just to get a little more granularity on the one, two sales number. Greg, can you disclose what the number of vials that were, I guess, dispersed from your distributor over the quarter? Secondly, I think you talked about a gross to net of 11% for the Q1 here. Just curious where you expect that gross to net to go once you have more comprehensive formulary coverage. I have a couple reimbursement questions.

Serge Belanger: Hi. Good afternoon. Thanks for taking my questions. I guess a few on just to get a little more granularity on the one, two sales number. Greg, can you disclose what the number of vials that were, I guess, dispersed from your distributor over the quarter? Secondly, I think you talked about a gross to net of 11% for the Q1 here. Just curious where you expect that gross to net to go once you have more comprehensive formulary coverage. I have a couple reimbursement questions.

Speaker #8: Greg, can you disclose what the number of vials that were I guess dispersed from your distributor over the quarter? And then secondly, I think you talked about a gross index of 11% for the first quarter here.

Speaker #8: Just curious where you expect that gross to net to go once you have more comprehensive formulary coverage? And then I have some a couple of reimbursement questions.

Speaker #2: Sure. In response to your first question, no. We aren't providing the number of vials. We're providing gross and net revenue numbers. With respect to your second around what is what constitutes the that gross to net number, that really is made up of chargebacks and fees.

Gregory A. Demopulos: Sure. In response to your first question, no, we aren't providing the number of vials. We're providing gross and net revenue numbers. With respect to your second around what constitutes the gross to net number, that really is made up of chargebacks and fees. Chargebacks meaning governmental programs, so 340B, and fees being largely bona fide fees to distributors. So that's largely it. We would expect that over time to increase as 340B participation increases. With respect to a target, I would not expect that to be reaching the 20 percentile. I would be thinking we're going to remain in the teens on that search. We'll have to see how that plays out. We are not planning at all to discount the drug.

Greg Demopulos: Sure. In response to your first question, no, we aren't providing the number of vials. We're providing gross and net revenue numbers. With respect to your second around what constitutes the gross to net number, that really is made up of chargebacks and fees. Chargebacks meaning governmental programs, so 340B, and fees being largely bona fide fees to distributors. So that's largely it. We would expect that over time to increase as 340B participation increases. With respect to a target, I would not expect that to be reaching the 20 percentile. I would be thinking we're going to remain in the teens on that search. We'll have to see how that plays out. We are not planning at all to discount the drug.

Speaker #2: So chargebacks meaning governmental programs so 340(b). And fees being largely bona fide fees to distributors. So that's largely it. We would expect that over time to increase as 340(b) participation increases.

Speaker #2: With respect to a target, I would not expect that to be reaching the 20th percentile. I would be thinking we're going to remain in the teens on that search.

Speaker #2: But we'll have to we'll have to see how that plays out. We are not planning at all to discount the drug. So and I think returns are I don't think we've had any but I think that will be negligible.

Gregory A. Demopulos: And I think returns are, I don't think we've had any, but I think that will be negligible. Going forward, I would expect the components of the gross to net to be what they were in Q1, which is the chargebacks, and the fees only.

Greg Demopulos: And I think returns are, I don't think we've had any, but I think that will be negligible. Going forward, I would expect the components of the gross to net to be what they were in Q1, which is the chargebacks, and the fees only.

Speaker #2: So, going forward, I would expect the components of the gross to net to be what they were in Q1, which is the chargebacks and the fees only.

Speaker #8: Got it. And then, regarding P&T approvals, clearly you've got some good traction through the end of the first quarter here with the numbers you gave us.

Serge Belanger: Got it. Then regarding P&T approvals, clearly you got some good traction through the end of Q1 here with the numbers you gave us.

Serge Belanger: Got it. Then regarding P&T approvals, clearly you got some good traction through the end of Q1 here with the numbers you gave us.

Gregory A. Demopulos: Yeah.

Greg Demopulos: Yeah.

Serge Belanger: Curious when you expect the rest of them to go through the P&T approval process. Are they already scheduled? Secondly, you talked that you got approval for a J-code as well as the NTAP for later this year. Curious, since you said that most centers have had some very good access to the product, access hasn't been an issue, will these J-codes and I guess, and NTAP, you know, what kind of impact could they have on further uptake once they are in effect?

Speaker #8: Curious when you expect the rest of them to go through the P&T approval process. Are they already scheduled? And then secondly, you talked at you got approval for J-code as well as the NTAP for later this year.

Serge Belanger: Curious when you expect the rest of them to go through the P&T approval process. Are they already scheduled? Secondly, you talked that you got approval for a J-code as well as the NTAP for later this year. Curious, since you said that most centers have had some very good access to the product, access hasn't been an issue, will these J-codes and I guess, and NTAP, you know, what kind of impact could they have on further uptake once they are in effect?

Speaker #8: Curious, since you said that most centers have had some very good access to the product—access hasn’t been an issue—will these J-codes and, I guess, NTAP, what kind of impact could they have on further uptake once they, or if, in effect?

Speaker #2: Yeah. First of all, with respect to P&T committees, there are a number of them that are in process. Remember, we launched this in mid-January, the third week of January.

Gregory A. Demopulos: Yeah. First of all, with respect to P&T committees, there are a number of them that are in process. Remember, we launched this in mid-January, third week of January. We are really still very early in the process. The P&T committee approvals that we've seen, as I mentioned, are quite satisfying in that they are well ahead of what we would have expected in terms of just timeline and number of P&T approvals. Clearly, there is an urgency, I think, that's being recognized and manifest across the sites, with physicians and pharmacists recognizing the value of YARTEMLEA and moving quickly to make it available. There are centers obviously that are approving access to the drug absent P&T approvals.

Greg Demopulos: Yeah. First of all, with respect to P&T committees, there are a number of them that are in process. Remember, we launched this in mid-January, third week of January. We are really still very early in the process. The P&T committee approvals that we've seen, as I mentioned, are quite satisfying in that they are well ahead of what we would have expected in terms of just timeline and number of P&T approvals. Clearly, there is an urgency, I think, that's being recognized and manifest across the sites, with physicians and pharmacists recognizing the value of YARTEMLEA and moving quickly to make it available. There are centers obviously that are approving access to the drug absent P&T approvals.

Speaker #2: So we are really still very early in the process. And the P&T committee approvals that we've seen, as I mentioned, are quite satisfying, in that they are well ahead of what we would have expected in terms of just timeline and number of P&T approvals.

Speaker #2: So clearly, there is an urgency, I think, that's being recognized and manifest across the sites. With physicians and pharmacists recognizing the value of Yartemlia and moving quickly to make it available.

Speaker #2: There are centers, obviously, that are approving access to the drug absent P&T approvals. But additional P&T approvals will certainly help that access—streamline it, make it more quick, more efficient.

Gregory A. Demopulos: Additional P&T approvals will certainly help that access, streamline it, make it more quick, more efficient. With respect to when we would expect all of those to have gone through the P&T process, as an absolute number, I would expect that the large majority of them will be coming through in the next few months. Your second question about the J-code and the NTAP. Well, the J-code certainly streamlines the billing process and the reimbursement process. Certainly having the J-code now awarded and going into effect on 1 July, I think will be very helpful. The NTAP CMS has, in its proposed Inpatient Prospective Payment System rule, has indicated that they support the approval of the NTAP for YARTEMLEA. That, we expect, will be finalized in the Inpatient final rule in August.

Greg Demopulos: Additional P&T approvals will certainly help that access, streamline it, make it more quick, more efficient. With respect to when we would expect all of those to have gone through the P&T process, as an absolute number, I would expect that the large majority of them will be coming through in the next few months. Your second question about the J-code and the NTAP. Well, the J-code certainly streamlines the billing process and the reimbursement process. Certainly having the J-code now awarded and going into effect on 1 July, I think will be very helpful. The NTAP CMS has, in its proposed Inpatient Prospective Payment System rule, has indicated that they support the approval of the NTAP for YARTEMLEA. That, we expect, will be finalized in the Inpatient final rule in August.

Speaker #2: With respect to when we would expect all of those to have gone through the P&T process, all is a is an absolute number I would expect that the large majority of them will be coming through in the next in the next few months.

Speaker #2: Your second question about the J-code and the NTAP. Will the J-code certainly streamlines the billing process? And the reimbursement process. So certainly having the J-code now awarded and going into effect on July 1, I think, will be very helpful.

Speaker #2: The NTAP CMS has in its proposed inpatient prospective payment systems rule has indicated that they support the approval of the NTAP for Yartemlia. That we expect will be finalized in the inpatient final rule in August.

Gregory A. Demopulos: Assuming that's the case, it will become or should become finalized and available for use on 1 November or sometime very close to 1 November. It runs on CMS's schedule. Both of those, the J-code and the NTAP, I expect will obviously help with reimbursement. Anytime you have secured reimbursement, that certainly helps with utilization. I think, you know, it's been quite surprising, frankly, how broadly YARTEMLEA has been used in the absence of the historical reimbursement already in place. Once, as you know, Serge, once that reimbursement becomes much more standard, and much more well-recognized, that just drives front-end utilization as it should.

Speaker #2: Assuming that's the case, it will become or should and available for use on November 1st or sometime very close to November 1st. It runs on CMS's schedule.

Greg Demopulos: Assuming that's the case, it will become or should become finalized and available for use on 1 November or sometime very close to 1 November. It runs on CMS's schedule. Both of those, the J-code and the NTAP, I expect will obviously help with reimbursement. Anytime you have secured reimbursement, that certainly helps with utilization. I think, you know, it's been quite surprising, frankly, how broadly YARTEMLEA has been used in the absence of the historical reimbursement already in place. Once, as you know, Serge, once that reimbursement becomes much more standard, and much more well-recognized, that just drives front-end utilization as it should.

Speaker #2: Both of those—the J-code and the NTAP, I expect—will obviously help with reimbursement. Anytime you have secured reimbursement, that certainly helps with utilization.

Speaker #2: So I think I'm quite it's been quite surprising frankly how broadly Yartemlia has been used in the absence of the historical reimbursement already in place.

Speaker #2: But once as you know, Serge, once that reimbursement becomes much more standard, and much more well-recognized, that just drives front-end utilization as it should.

Speaker #8: Right. Thank you.

Serge Belanger: Right. Thank you.

Serge Belanger: Right. Thank you.

Speaker #2: All right. Thank you.

Gregory A. Demopulos: All right. Thank you.

Greg Demopulos: All right. Thank you.

Speaker #1: There are no further questions at this time. I will now turn the call back to Dr. Demopulos for closing remarks.

Operator: There are no further questions at this time. I will now turn the call back to Dr. Demopulos for closing remarks.

Operator: There are no further questions at this time. I will now turn the call back to Dr. Demopulos for closing remarks.

Speaker #2: All right. Thank you. Thank you, operator. And thank you all for joining us this afternoon. As we've said, we're pleased with the strength of the Yartemlia launch and the continued progress across our pipeline and our platform programs.

Gregory A. Demopulos: Thank you. Thank you operator, thank you all for joining us this afternoon. As we've said, we're pleased with the strength of the YARTEMLEA launch and the continued progress across our pipeline and our platform programs. With expanding commercial momentum, multiple near-term catalysts, and continued execution across the organization, we believe Omeros is well-positioned for continued growth and long-term value creation. As always, we appreciate your continued support and confidence. Have a good evening.

Greg Demopulos: Thank you. Thank you operator, thank you all for joining us this afternoon. As we've said, we're pleased with the strength of the YARTEMLEA launch and the continued progress across our pipeline and our platform programs. With expanding commercial momentum, multiple near-term catalysts, and continued execution across the organization, we believe Omeros is well-positioned for continued growth and long-term value creation. As always, we appreciate your continued support and confidence. Have a good evening.

Speaker #2: With expanding commercial momentum, multiple near-term catalysts, and continued execution across the organization, we believe Omeros is well-positioned for continued growth and long-term value creation.

Speaker #2: As always, we appreciate your continued support and confidence. Have a good evening.

Operator: This concludes today's call. Thank you for attending. You may now disconnect.

Operator: This concludes today's call. Thank you for attending. You may now disconnect.

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Q1 2026 Omeros Corp Earnings Call

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Omeros

Earnings

Q1 2026 Omeros Corp Earnings Call

OMER

Wednesday, May 13th, 2026 at 8:30 PM

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