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OMER

OmerosD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-06-02
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2026-05-14
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Earnings documents stored for OMER.

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Investor releaseQuarter not tagged2026-05-14

Omeros Corp (OMER) Q1 2026 Earnings Call Highlights: Strong YARTEMLEA Launch and Strategic ...

GuruFocus.com

This article first appeared on GuruFocus. YARTEMLEA Gross Revenues: $11.1 million in the first quarter. YARTEMLEA Net Revenues: $9.9 million, reflecting gross-to-net adjustments of approximately 11%. Net Income: $56.1 million or $0.78 per share, including a $73.1 million non-cash mark-to-market gain. Adjusted Net Loss: $17.1 million or $0.24 per share, excluding non-cash items. Cash and Investments: $135.3 million as of March 31, 2026. Share Repurchase: Approximately 360,000 shares repurchased at an average price of $11.70 per share, totaling $4.2 million. Upfront Cash from Novo Nordisk Deal: $240 million received. Interest Expense: $5.9 million in the first quarter. Interest and Other Income: $1.5 million in the first quarter. Operating Expenses: $27.3 million for the first quarter before interest and other income. Warning! GuruFocus has detected 2 Warning Sign with OMER. Is OMER fairly valued? Test your thesis with our free DCF calculator. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Omeros Corp (NASDAQ:OMER) successfully launched YARTEMLEA, the first and only approved treatment for TA-TMA, generating $11.1 million in gross revenues and $9.9 million in net revenues in the first quarter. The company received $240 million in upfront cash from a transaction with Novo Nordisk, with potential for an additional $100 million in near-term milestone payments. YARTEMLEA has been adopted by 30 unique accounts, with significant uptake in major transplant centers, indicating strong early demand. The FDA approval of YARTEMLEA and the assignment of a Permanent Healthcare Common Procedure Coding System (J-code) by CMS are expected to simplify billing and reimbursement, enhancing patient access. Omeros Corp (NASDAQ:OMER) is expanding its MASP-2 program and exploring additional indications for YARTEMLEA, including ARDS and sickle cell disease, which could broaden its market potential. Despite the positive launch of YARTEMLEA, Omeros Corp (NASDAQ:OMER) reported a non-GAAP adjusted net loss of $17.1 million for the first quarter. The company faces volatility in its financial results due to non-cash mark-to-market adjustments on embedded derivatives, which can significantly impact reported earnings. Omeros Corp (NASDAQ:OMER) is still in the early stages of YARTEMLEA's launch, with no revenue gui...

Investor releaseQuarter not tagged2026-05-14

Omeros Corporation Reports First Quarter 2026 Financial Results

Business Wire

– Conference Call Today at 4:30 p.m. ET SEATTLE, May 13, 2026--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the first quarter ended March 31, 2026, which include: First Quarter and Recent Highlights In January 2026, we launched YARTEMLEA® in the U.S. market. During the quarter, gross product sales were $11.1 million and associated net sales, after deduction of wholesaler distribution fees and chargebacks, were $9.9 million. Net income for the first quarter of 2026 was $56.1 million, or $0.78 per share, compared to a net loss of $33.5 million, or $0.58 per share, for the first quarter of 2025. First quarter results include a $73.1 million non-cash gain associated with the mark-to-market adjustment on the embedded derivatives related to our 2029 unsecured convertible notes (the "2029 Notes"). Excluding the non-cash change in our embedded derivatives, non-GAAP adjusted net loss for the three months ended March 31, 2026 was $17.1 million, or $0.24 per share. At March 31, 2026, we had $135.3 million of cash and short-term investments. This balance includes the February 2026 repayment at maturity of the remaining $17.1 million aggregate principal amount of our 2026 unsecured convertible notes (the "2026 Notes"). Following that repayment, our only remaining debt outstanding is $70.8 million aggregate principal amount of our 2029 Notes, which mature in June 2029. In April, the U.S. Centers for Medicare & Medicaid Services ("CMS") assigned a permanent Healthcare Common Procedure Coding System J-code specific for YARTEMLEA. This simplifies billing and reimbursement across payors. The J-code becomes effective on July 1, 2026. Also in April, CMS, in its Inpatient Prospective Payment System proposed rule, recommended approval of the New Technology Add-On Payment ("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 expected to be effective October 1, 2026. "The launch of YARTEMLEA has changed the trajectory of Omeros, both operationally and financially," said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. "We are seeing strong early adoption across transplant centers, expand...

Investor releaseQuarter not tagged2026-05-14

Omeros Q1 Earnings Call Highlights

MarketBeat

Interested in Omeros Corporation? Here are five stocks we like better. YARTEMLEA launched in January and generated $11.1 million in gross revenue in Q1, with early uptake described as strong. Omeros said the drug became cash flow positive in the quarter and could drive company-wide positive cash flow within 18 months. The launch is advancing quickly across transplant centers, with 30 unique accounts ordering by quarter-end and reimbursement gains including full approvals on prior authorizations and a permanent CMS J-code effective July 1. CMS also recommended NTAP approval, which could further support hospital adoption. Omeros ended Q1 with $135.3 million in cash and investments after receiving $240 million upfront from its Novo Nordisk deal and paying off its 2026 notes. Excluding a large non-cash derivative gain, the company posted a non-GAAP adjusted net loss of $17.1 million. Breakout Momentum Plays You Need to Know About Omeros (NASDAQ:OMER) reported first-quarter 2026 net income of $56.1 million, or $0.78 per share, as the company began commercial sales of YARTEMLEA, its recently approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA. Chairman and Chief Executive Officer Dr. Gregory Demopulos said YARTEMLEA generated gross revenue of $11.1 million and net revenue of $9.9 million in the quarter, reflecting gross-to-net adjustments of about 11%. The product launched in January, with initial shipments to distributors beginning in mid-month. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? Demopulos said early demand and uptake were “strong” and that YARTEMLEA became cash flow positive in the first quarter despite the mid-January launch. He said the company expects the drug to drive company-wide positive cash flow within 18 months. YARTEMLEA was approved by the U.S. Food and Drug Administration as the first and only approved treatment for TA-TMA and the first approved inhibitor of the lectin pathway of complement, according to Demopulos. Omeros is focusing the launch on educating transplant teams, securing hospital Pharmacy and Therapeutics committee approvals, ensuring reimbursement and supporting pricing through health economics and outcomes research. → MP Materials Is Quietly Building a Rare Earth Powerhouse Demopulos said the company’s field force is detailing all 175 transplan...

Investor releaseQuarter not tagged2026-05-14

Omeros: Q1 Earnings Snapshot

Associated Press

SEATTLE (AP) — SEATTLE (AP) — Omeros Corporation (OMER) on Wednesday reported profit of $56.1 million in its first quarter. The Seattle-based company said it had profit of 62 cents per share. Losses, adjusted for non-recurring gains and to account for discontinued operations, came to 24 cents per share. The drug developer posted revenue of $9.9 million in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on OMER at https://www.zacks.com/ap/OMER

Investor releaseQuarter not tagged2026-05-14

Omeros (OMER) Q1 2026 Earnings Transcript

Motley Fool

Image source: The Motley Fool. Wednesday, May 13, 2026 at 4:30 p.m. ET Chairman & Chief Executive Officer — Gregory Demopulos Chief Accounting Officer — David Borges Chief Regulatory Officer — Catherine Melfi Vice President, Clinical — Steve Whitaker Need a quote from a Motley Fool analyst? Email [email protected] Gregory Demopulos: Thank you, Jennifer, and 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 of Clinical. 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. We entered 2026 with 2 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. We launched in January with initial shipments to distributors beginning mid-month, followed shortly by first sales. In the first quarter, 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 the first quarter despite a mid-January launch and we expect it to drive company-wide positive cash flow within 18 months. Net income for the first quarter was $56.1 million, or $0.78 per share, including a $73.1 million noncash mark-to-market gain on the embedded derivative associated with our 2029 convertible notes. Excluding this noncash item, adjusted net gross loss was -- or net loss was $17.1 million, or $0.24 per share. We ended the quarter with $135.3 million in cash and investments after retiring our remaining 2026 convertible notes. 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. We may continue to repurchase shares from time to time,...

Investor releaseQuarter not tagged2026-05-14

Omeros Corporation Q1 2026 Earnings Call Summary

Moby

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. The YARTEMLEA launch in mid-January 2026 achieved $11.1 million in gross revenue, driven by rapid institutional adoption and strong prescriber demand across 30 unique accounts. Management attributes the accelerated uptake to high clinical urgency in treating TA-TMA, with P&T committee approvals moving faster than the typical 6-to-9-month timeline. The company achieved cash flow positivity for YARTEMLEA within its first partial quarter and expects the product to drive company-wide positive cash flow within 18 months. Strategic capital was bolstered by the closing of the zaltenibart transaction with Novo Nordisk, providing $240 million in upfront cash to fund operations and the commercial launch. Early commercial focus is centered on educating transplant teams, securing institutional access, and demonstrating economic value through health economics and outcomes research. The MASP-2 platform is being broadened beyond TA-TMA to include chronic indications like renal and neurological disorders via long-acting antibodies and oral small molecules. Management expects a regulatory decision from the European Medicines Agency regarding YARTEMLEA in TA-TMA by midyear 2026. The implementation of a permanent J-code on July 1 and the expected NTAP approval in October are anticipated to streamline reimbursement and further drive front-end utilization. Operating expenses are projected to increase slightly in the second quarter of 2026 as the company continues to build out its commercial infrastructure for YARTEMLEA. Clinical milestones include the targeted initiation of an inpatient human study for OMS527 in cocaine users by year-end and first-in-human trials for OncotoX-AML in late 2027. The company is actively evaluating global and regional partnerships to support the commercialization of YARTEMLEA outside of the United States. Reported net income of $56.1 million was significantly impacted by a $73.1 million noncash mark-to-market gain on embedded derivatives, which introduces volatility based on stock price fluctuations. The company retired its remaining 2026 convertible notes, leaving $70.8 million in principal outstanding on 2029 notes as its only remaining debt. A share repurchase program is active, with 360,000 share...

TranscriptFY2026 Q12026-05-13

FY2026 Q1 earnings call transcript

Earnings source - 91 paragraphs
Operator

Good afternoon. 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. Please be advised that this call is being recorded at the company's request. A replay will be available on the company's website. I'll now turn the call over to Jennifer Williams, investor relations for Omeros. Please go ahead.

Jennifer Williams

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. For a detailed discussion of these risks and uncertainties, please refer to the special note regarding forward-looking statements and the risk factors sections 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. 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.

Jennifer Williams

With that, I'll turn the call over to Dr. Gregory A. Demopulos, Chairman and CEO of Omeros.

Gregory Demopulos

Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer, Dr. Kathy Melfi, our Chief Regulatory Officer, and Dr. Steve Whitaker, Vice President of Clinical. 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. We entered 2026 with 2 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.

Gregory Demopulos

We launched in January with initial shipments to distributors beginning mid-month, followed shortly by first sales. In the first quarter, 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 the first quarter despite a mid-January launch, and we expect it to drive company-wide positive cash flow within 18 months. Net income for the first quarter 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, adjusted net loss was $17.1 million or $0.24 per share.

Gregory Demopulos

We ended the quarter with $135.3 million in cash and investments after retiring our remaining 2026 convertible notes. 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. 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.

Gregory 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 four 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 March 31, 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.

Gregory 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 U.S. centers had received P&T committee approval. Looking at reimbursement, all prior authorization requests submitted to third-party commercial payers to date have been approved. Centers have begun receiving full payment. HEOR analyses which support 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 U.S. Centers for Medicare & Medicaid Services, or CMS, assigned a permanent Healthcare Common Procedure Coding System J-code for YARTEMLEA.

Gregory Demopulos

This simplifies billing and reimbursement across payers, reduces administrative burden, supports faster patient access, and improves reimbursement predictability. The J-code becomes effective July 1. 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 October 1 of this year. We remain focused on expansion opportunities for YARTEMLEA and our MASP-2 program. Beyond the U.S., our marketing authorization application for YARTEMLEA in TATMA is under review by the European Medicines Agency. We continue to expect a decision mid-year. We are evaluating potential partnerships, including broad ex-U.S. and regional collaborations to support commercialization outside the U.S.

Gregory Demopulos

Beyond TA-TMA, 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.

Gregory Demopulos

Let's now turn to development programs beyond our complement inhibitor franchise. 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. 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.

Gregory 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 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. 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, 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.

Gregory 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.

Gregory 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?

David Borges

Thanks, Greg. Net income for the first quarter of 2026 was $56.1 million or $0.78 per share compared to net income of $86.5 million or $1.22 per share in the fourth quarter of 2025. 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 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

Excluding the $73.1 million embedded derivative adjustment, non-GAAP adjusted net loss for the first quarter of 2026 was $17.1 million, and non-GAAP adjusted net loss per share was $0.24 per share. As of March 31st, 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. 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

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. As Greg mentioned, YARTEMLEA launched in mid-January 2026. Gross revenues for the first quarter 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

Costs and expenses from continuing operations for the first quarter before interest and other income were $27.3 million, a decrease of $1.8 million from the fourth quarter of 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 FTE cost, are being reimbursed by Novo Nordisk. 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.

David Borges

Excluding the DRI, the Midway royalty obligation, which represents pass-through 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 the first quarter of 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 the first quarter, up from $1.1 million in the fourth quarter of 2025, primarily reflecting higher average cash balances. As previously mentioned, during the first quarter, 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

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. An increase in stock price in the second quarter would similarly result 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. This embedded derivative reflects certain features of the notes, including the conversion option and interest make-whole provision available to the note holders. 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. This adjustment is non-cash and does not affect our operating performance or liquidity.

David Borges

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 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 OMIDRIA royalties. Because U.S.-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 second quarter 2026 results. We anticipate that overall operating expenses from continuing operations will be slightly higher compared to the first quarter of 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

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 the first quarter. 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 million-$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

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, turn the call back over to Greg.

Gregory Demopulos

Thanks, David. Operator, please open the call to questions.

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 buttom 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.

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 requests drug to the time you get it, can you detail how long you get it to the hospital? Can you detail us how long it takes and the process, please?

Gregory Demopulos

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

Steve Brozak

Okay.

Gregory Demopulos

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

Steve Brozak

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

Gregory 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 the first quarter, 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.

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?

Gregory Demopulos

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 than is represented by the overall split in TA-TMA between adults and pediatrics. We are seeing those pediatric transplanters requesting narsoplimab or YARTEMLEA.

Steve Brozak

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

Gregory Demopulos

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

Steve Brozak

And-

Gregory 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 %. I think if I put it in absolute numbers, it may be helpful.

Steve Brozak

Yeah. You can do that

Gregory Demopulos

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

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 oncologist in prescribing or anyone else on the clinician side? Thank you. I'll jump back in the queue.

Gregory Demopulos

Sure. 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 YARTEMLEA are impressive. Again, we're early in the launch, but as I said, all signs look very encouraging. We do expect that YARTEMLEA will become standard of care for the treatment of TA-TMA.

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 Demopulos

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

Operator

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

Olivia Brayer

Hi, good afternoon, guys, and thank you for the question. I know it's early, Greg, how are you thinking about the split between inventory versus U.S. 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?

Gregory Demopulos

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

Olivia Brayer

Yes.

Gregory Demopulos

You were on Diane, maybe.

Olivia Brayer

Yeah. It was just a question about how many patients are actually on drug as of today?

Gregory Demopulos

Sure

Olivia Brayer

that are being treated with YARTEMLEA.

Gregory 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 one and a half 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. That is I'm not trying to dodge the question.

Gregory 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.

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?

Gregory 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.

Gregory Demopulos

Our understanding is that the patients in that controlled adult trial, by definition, would really need to be less severe than the patients we treated, 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.

Steve Whitaker

Hi, Greg. This is Steve. We only know what's on clinicaltrials.gov at this point. The primary endpoint is event-free survival. 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. Those are lower secondary endpoints. Obviously, I don't have the protocol, so I don't know how these were ranked hierarchically. Those are pretty far down the line, if that helps.

Olivia Brayer

Yep, that's great. Thank you, guys. Appreciate it.

Gregory 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, 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. Those might be something that would help you as well.

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.

Gregory Demopulos

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

Olivia Brayer

Nope. That's perfect. Thank you, guys.

Gregory Demopulos

Great.

Olivia Brayer

Appreciate the follow-up.

Gregory Demopulos

Thank you very much.

Operator

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

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.

Gregory 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, 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.

Gregory 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 first quarter, catching patients who were falling knives, and 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.

Brandon Folkes

It does. Thanks so much, Greg. Sorry.

Gregory Demopulos

Oh, thanks, Brandon.

Brandon Folkes

Sorry, just dealing with the mute button.

Gregory Demopulos

No, that's fine. Any other questions?

Operator

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

Serge Belanger

Hi, good afternoon. Thanks for taking my questions. I guess a few on just to get a little more granularity on the 1Q 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 nets of 11% for the first quarter here. Just curious where you expect that gross to net to go once you have more comprehensive formulary coverage. I have some a couple reimbursement questions.

Gregory 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 that gross to net number, that really is made up of chargebacks and fees. Chargebacks, meaning governmental programs, so 340B, and fees being largely bonafide fees to distributors. 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, but we'll have to see how that plays out. We are not planning at all to discount the drug.

Gregory 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.

Serge Belanger

Got it. Regarding P&T approvals, clearly, you got some good traction through the end of the first quarter here with the numbers.

Gregory Demopulos

Yes.

Serge Belanger

you gave us.

Gregory Demopulos

Yes.

Serge Belanger

Curious, when do 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?

Gregory Demopulos

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, 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. 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.

Gregory Demopulos

There are centers, obviously, that are approving access to the drug absent P&T approvals, 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. All is a, is 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. The J-code certainly streamlines the billing process and the reimbursement process. Certainly having the J-code now awarded and going into effect on July one, I think will be very helpful.

Gregory Demopulos

The NTAP CMS has, in its proposed inpatient prospective payment systems 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. Assuming that's the case, it will become or should become finalized and available for use on November 1st, or sometime very close to November 1st. It runs on CMS's schedule. Both of those, the J-code and the NTAP, I expect will obviously help with reimbursement. Any time 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.

Gregory Demopulos

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.

Serge Belanger

Right. Thank you.

Gregory Demopulos

All right. Thank you.

Operator

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

Gregory Demopulos

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 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.

Operator

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

Investor releaseQuarter not tagged2026-05-12

Omeros Corporation to Announce First Quarter Financial Results on May 13, 2026

Business Wire

SEATTLE, May 11, 2026--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER) today announced that it will issue its financial results for the first quarter 2026 on Wednesday, May 13, 2026 after market close. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss recent developments and highlights as well as the Company’s financial results. Conference Call Details and Webcast Link Instructions To access the live webcast, please click here or visit the "Upcoming Events" section of the Investor Relations page of Omeros’ website. A replay of the call will be available for 90 days in the "Archived Events" section of the Investor Relations page of Omeros’ website. As Omeros continues to transition to a new earnings call platform (hosted by Q4 Inc.), please allow extra time to log in prior to the start of the call. About Omeros Corporation Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead complement inhibitor YARTEMLEA® (narsoplimab-wuug), which targets the lectin pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older. A marketing authorization application seeking approval of YARTEMLEA for TA-TMA is currently under review at the European Medicines Agency. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials. Under a recently announced asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), an inhibitor of MASP-3, the alternative pathway’s key activator, which is in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms an...

Investor releaseQuarter not tagged2026-04-01

Omeros: Q4 Earnings Snapshot

Associated Press

SEATTLE (AP) — SEATTLE (AP) — Omeros Corporation (OMER) on Tuesday reported net income of $86.5 million in its fourth quarter. On a per-share basis, the Seattle-based company said it had net income of 98 cents. Earnings, adjusted for one-time gains and costs, were $3.14 per share. For the year, the company reported a loss of $3.4 million, or 5 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on OMER at https://www.zacks.com/ap/OMER

Investor releaseQuarter not tagged2026-04-01

Omeros Corporation Reports Fourth Quarter and Year-End 2025 Financial Results

Business Wire

– Conference Call Today at 4:30 p.m. ET SEATTLE, March 31, 2026--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2025, which include: Net income for the fourth quarter of 2025 was $86.5 million, or $1.22 per share, compared to a net loss of $31.4 million, or $0.54 per share, for the fourth quarter of 2024. For the year ended December 31, 2025, net loss was $3.4 million, or $0.05 per share, compared to a net loss of $156.8 million, or $2.70 per share, in the prior year. Fourth quarter results include a net gain of $237.6 million tied to the zaltenibart transaction with Novo Nordisk. The fourth quarter also includes a $136.0 million non-cash charge associated with the mark-to-market adjustment on the embedded derivatives related to our 2029 Notes and Term Loan. Excluding the non-cash charge associated with the embedded derivatives, non-GAAP adjusted net income for the three months and year ended December 31, 2025 was $222.5 million, or $3.14 per share, and $133.4 million, or $2.10 per share, respectively. At December 31, 2025, we had $171.8 million of cash and short-term investments. We had $87.9 million in aggregate principal amount of debt at December 31, 2025, reflecting a decrease of $77.1 million, or 47%, compared to $164.9 million in aggregate principal amount of debt at December 31, 2024. Fourth Quarter and Recent Highlights On November 25, 2025, we closed the previously announced transaction with Novo Nordisk Health Care AG ("Novo Nordisk"). Pursuant to the Asset Purchase and License Agreement ("APLA"), Novo Nordisk received exclusive global rights in all indications to develop and commercialize zaltenibart (formerly OMS906), our lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 ("MASP-3") and certain related antibodies and products. Omeros retains rights to its MASP-3 small-molecule program unrelated to zaltenibart, including the ability to develop and commercialize small-molecule MASP-3 inhibitors with limited restrictions on indications. Omeros also retains rights to its "grandfathered" MASP-3 antibodies, with temporal and indication restrictions on commercialization and for use in advancing its small-molecule therapeutics. At closing, we received an upfront cash payment of $2...

Investor releaseQuarter not tagged2026-04-01

Omeros Corporation Q4 2025 Earnings Call Summary

Moby

The company transitioned to a commercial-stage organization following the late December FDA approval of YARTEMLEA, the first and only treatment for TA-TMA. A strategic asset sale of zaltenibart to Novo Nordisk for up to $2.1 billion provided substantial non-dilutive capital, allowing for the full repayment of senior secured debt. YARTEMLEA's competitive positioning is driven by its upstream MASP-2 inhibition, which preserves immune function and avoids the 'black box' warnings and REMS programs required for C5/C3 inhibitors. Management attributes early launch success to pre-approval education efforts, with field forces already detailing centers representing 90% of U.S. allogeneic transplant volume. The commercial strategy focuses on the 80 highest-volume transplant centers, which account for approximately 80% of the total U.S. market opportunity. Operational efficiency is supported by a Transition Services Agreement with Novo Nordisk, where Omeros is reimbursed for employee and program costs related to zaltenibart. Management expects the YARTEMLEA commercial program to be financially self-sustaining within 2026, with a target for total company positive cash flow in 2027. A regulatory decision from the EMA regarding YARTEMLEA's marketing authorization in Europe is anticipated by mid-year 2026. The company plans to advance its MASP-2 pipeline, including the Phase II-ready long-acting antibody OMS1029 and a small-molecule program for chronic indications. Strategic expansion for YARTEMLEA is being evaluated in ARDS and solid organ transplant-related TMA to leverage its endothelial injury mechanism. Near-term financial milestones from Novo Nordisk totaling $100 million are characterized as 'achievable' and expected to further bolster the balance sheet. Reported net income was significantly impacted by a $136 million non-cash mark-to-market charge on embedded derivatives, driven by a 319% increase in stock price during Q4. The company extinguished all senior secured debt and 2026 convertible notes, leaving only $70.8 million in unsecured 2029 notes. FDA has requested additional preclinical data for the PDE7 inhibitor program (OMS527) before initiating human inpatient studies for cocaine use disorder. A $17 million non-cash gain was recognized in Q4 related to the derecognition of unamortized premiums following the term loan repayment. Our analysts just identified a...

Investor releaseQuarter not tagged2026-04-01

Omeros Corp (OMER) Q4 2025 Earnings Call Highlights: A Turnaround with Strategic Deals and FDA ...

GuruFocus.com

This article first appeared on GuruFocus. Net Income (Q4 2025): $86.5 million or $1.22 per share. Net Loss (Q3 2025): $30.9 million or $0.47 per share. Net Gain from Zaltnibart Transaction: $237.6 million. Non-GAAP Adjusted Net Income (Q4 2025): $222.5 million. Non-GAAP Adjusted Income per Share (Q4 2025): $3.14. Cash and Investments (Dec 31, 2025): $171.8 million. Upfront Payment from Novo Nordisk: $240 million. Outstanding Debt (2029 Convertible Notes): $70.8 million. Per Vial Price for YARTEMLEA: Approximately $36,000. Interest Expense (Q4 2025): $8.7 million. Costs and Expenses from Continuing Operations (Q4 2025): $29.1 million. Warning! GuruFocus has detected 3 Warning Signs with OMER. Is OMER fairly valued? Test your thesis with our free DCF calculator. Release Date: March 31, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Omeros Corp (NASDAQ:OMER) closed a significant asset purchase and license transaction with Novo Nordisk, valued at up to $2.1 billion, providing substantial upfront and milestone payments. FDA approval of YARTEMLEA, the first and only approved treatment for TA-TMA, marks a major milestone for the company. The company reported a net income of $86.5 million for Q4 2025, a significant turnaround from the previous quarter's loss. Omeros Corp (NASDAQ:OMER) has successfully deployed its field force and achieved early sales of YARTEMLEA, with positive feedback from transplant centers. The company has strengthened its balance sheet by repaying significant portions of its debt, leaving only $70.8 million in outstanding convertible notes. Omeros Corp (NASDAQ:OMER) incurred a $136 million non-cash charge related to mark-to-market adjustments on its convertible notes, affecting reported results. The company is not providing revenue guidance for YARTEMLEA due to the early stage of its launch, creating uncertainty for investors. Despite early successes, the company faces challenges in achieving full formulary coverage for YARTEMLEA across all top transplant centers. There is a need for ongoing education and awareness efforts to ensure the adoption of YARTEMLEA, which may delay widespread usage. The company is still in the process of securing European approval for YARTEMLEA, with potential pricing and market access challenges ahead. Q: How should we think about the progress of formulary ad...

As of 2026-05-30 • Updated weeklySource: Earnings sourceIngestion runbook