Earnings Call
Omeros Corp (OMER)
Earnings Call Transcript - OMER Q1 2026
Operator, Operator
Good afternoon, and welcome to today's earnings call for Omeros Corporation. 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. Please go ahead.
Jennifer Williams, Investor Relations
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 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. 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.
Gregory Demopulos, Chairman and CEO
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 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, subject to market conditions and other considerations. Our transaction with Novo Nordisk provided substantial nondilutive 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. 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; 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. 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. 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 and 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 and Medicaid Services, or CMS, assigned a permanent health care common procedure coding system, J-code for YARTEMLEA. 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. Also 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 TA-TMA is under review by the European Medicines Agency. We continue to expect a decision midyear. We are evaluating potential partnerships, including broad ex-U.S. and regional collaborations to support commercialization outside the U.S. 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. 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 nonclinical 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. Turning to our Targeted Complement Activating Therapy, or T-CAT 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, T-CAT is designed to kill pathogens regardless of resistance profile without promoting resistance. Data from our T-CAT 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 T-CAT 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. 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 nonhuman 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. 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. David?
David Borges, Chief Accounting Officer
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 noncash 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 noncash 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 noncash remeasurements of our embedded derivatives. Excluding the $73.1 million embedded derivative adjustment, non-GAAP adjusted net loss for the first quarter of '26 was $17.1 million and non-GAAP adjusted net loss per share was $0.24 per share. 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 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. 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 continue 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. 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 full-time employee, or FTE costs 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. Excluding the DRI OMIDRIA royalty obligation, which represents pass-through interest from Rayner to DRI and has no economic impact to us and excluding noncash amortization of debt issuance costs and discounts, contractual cash interest expense for the first quarter of '26 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 '25, primarily reflecting higher average cash balances. As previously mentioned, during the first quarter, we recorded a $73.1 million noncash gain from mark-to-market adjustment on the embedded derivative related to our 2029 convertible notes. 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 noncash loss during the quarter. Conversely, a decrease in our stock price during the second quarter would result in a noncash gain. This embedded derivative reflects certain features of the notes, including the conversion option and interest make-whole provision available to the noteholders. 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 noncash and does not affect our operating performance or liquidity. Accordingly, we present non-GAAP adjusted net income and net loss to exclude the noncash 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. Now 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 '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 YARTEMLEA. As YARTEMLEA 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. 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 noncash adjustments related to the OMIDRIA royalty obligation. Income from discontinued operations is expected to be in the $5 million to $6 million range, excluding any noncash remeasurement adjustment related to the OMIDRIA 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. These adjustments are noncash, 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, Chairman and CEO
Thanks, David. Operator, now please open the call to questions.
Operator, Operator
Your first question comes from the line of Steve Brozak with WBB.
Stephen Brozak, Analyst (WBB)
I'd like to go into some granularity on YARTEMLEA. My first question concerns the time from when the clinician requests the drug to when you receive it. Can you detail how long it takes to get the drug to the hospital and describe the process, please?
Gregory Demopulos, Chairman and CEO
Sure. The distributors deliver drug to the sites within about 24 hours of receipt of the request. And the process is pretty straightforward. The request is made to the distributors, distributors deliver within 24 hours.
Stephen Brozak, Analyst (WBB)
Okay. Can you give us some detail? Typically, in stem cell TA-TMA on the transplant side, about 15% of the population are pediatric patients. How does that reflect in what you've seen so far with requests for YARTEMLEA?
Gregory Demopulos, Chairman and CEO
Right. And 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. 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.
Stephen Brozak, Analyst (WBB)
Okay. Now I don't want to put words in your mouth, but typically, you would see the pediatric hematological oncologists being the most conservative. So you're saying that they are asking for YARTEMLEA in a greater number than the distribution. 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. Is that what I'm hearing?
Gregory Demopulos, Chairman and CEO
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 that is represented by the overall split in TA-TMA between adults and pediatrics. We are seeing those pediatric transplanters requesting narsoplimab or YARTEMLEA.
Stephen Brozak, Analyst (WBB)
Okay. I thought I was the only person mixing narsoplimab and YARTEMLEA. You may have said this earlier, but out of the total targeted facilities, how many have started prescribing or requesting them so far?
Gregory Demopulos, Chairman and CEO
At the end of March, by March 31, we had 30 separate accounts requesting YARTEMLEA. Of those 30, to add some context since we discussed percentages in the prepared remarks, giving absolute numbers may be helpful. Six of the top 10 sites had ordered by March 31, and 24 of the top 80 centers had ordered by March 31.
Stephen Brozak, Analyst (WBB)
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?
Gregory Demopulos, Chairman and CEO
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 YARTEMLEA are impressive. And again, we're early in the launch, but as I said, all signs look very encouraging. And we do expect that YARTEMLEA will become standard of care for the treatment of TA-TMA.
Stephen Brozak, Analyst (WBB)
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?
Gregory Demopulos, Chairman and CEO
Very good. Yes, we look forward to that as well.
Operator, Operator
Your next question comes from the line of Olivia Saunders with Cantor.
Olivia Brayer, Analyst (Cantor Fitzgerald)
I know it's early, but 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? And any comments on how many patients are actually on drug as of today?
Gregory Demopulos, Chairman and CEO
Sorry, I lost the second question, Olivia, what was that? It was muted on my end maybe.
Olivia Brayer, Analyst (Cantor Fitzgerald)
Yes. Just a question about how many patients are actually on drug as of today that are being treated with YARTEMLEA.
Gregory Demopulos, Chairman and CEO
Sure. First of all, with respect to inventory, given the short delivery process of 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 to 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 specific information about the number of patients, the type of patients, or any patient-specific information. What we really see is how many vials are going into a center and which centers are requesting those vials. I'm not trying to dodge the question; 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, but with respect to a specific number, we just don't have that information.
Olivia Brayer, Analyst (Cantor Fitzgerald)
Okay. Fair enough. And can I ask, how are you thinking about the AstraZeneca Ultomiris Phase III study that they're running in TMA? You think they're using disease relapse as an endpoint, and it is a randomized study. So I'm just curious if you have any thoughts on how that might fit into the landscape.
Gregory Demopulos, Chairman and CEO
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, 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. I think it had a 17% response rate. So I know that, as I understand it, 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 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 not be possible. So I think there's a difference in the severity of the patients. I don't know if they're looking at relapse. I'll open the question up to Steve and Cathy if you have any other information about AstraZeneca and their data.
Dr. Steve Whitaker, Vice President of Clinical
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. So it's not really relapse, as Greg said, it'd be worsening from their baseline condition. They do look at duration of response and relapse, but those are lower secondary endpoints. And 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.
Olivia Brayer, Analyst (Cantor Fitzgerald)
Yes, that's great.
Gregory Demopulos, Chairman and CEO
Yes. Thanks, Steve. 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 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. So those might be something that would help you as well.
Dr. Cathy Melfi, Chief Regulatory Officer
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. And currently, it's, as Steve said, event-free survival.
Gregory Demopulos, Chairman and CEO
So thank you, Cathy. So yes, so they had changed from response to survival. Okay. Anything else, Olivia?
Operator, Operator
Your next question comes from the line of Brandon Folkes with H.C. Wainwright.
Brandon Folkes, Analyst (H.C. Wainwright)
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 whether you believe once NTAP comes into practice, that may facilitate less friction to earlier intervention? Or what do you think drives earlier intervention?
Gregory Demopulos, Chairman and CEO
Certainly, we're focused on earlier intervention. We want to save as many patients as possible. Both our expectations and the data show that the earlier you address this problem, the greater the likelihood of a successful outcome. There appears to be growing awareness of that within the transplant community. We are receiving questions about earlier, upstream administration of YARTEMLEA, and I think that bodes well for patients. Will the NTAP help? Yes. The NTAP increases subsidization, substantially offsetting inpatient payments for Medicare patients, which is where you would expect the earliest treatment to begin. Your point about whether NTAP would help in that regard is insightful. We are waiting to see, but we expect an increasing move to earlier treatment, particularly since many of the patients we initially treated were eculizumab failures. We were often catching patients late, patients who were falling knives, and many of those responded very well to narsoplimab or to YARTEMLEA. I believe there is a growing understanding and awareness of moving upstream in the administration process, and that is good for patients. Does that help?
Brandon Folkes, Analyst (H.C. Wainwright)
It does. Sorry, just dealing with the mute button.
Gregory Demopulos, Chairman and CEO
No, that's fine. Any other questions?
Operator, Operator
Your next question comes from the line of Serge Belanger with Needham.
Serge Belanger, Analyst (Needham)
I have a few questions to get a little more granularity on the first-quarter sales number. Greg, can you disclose how many vials were distributed by your distributor over the quarter? Also, you mentioned a gross-to-net of 11% for the first quarter. Where do you expect that gross-to-net to go once you have more comprehensive formulary coverage? And I have a couple of reimbursement questions.
Gregory Demopulos, Chairman and CEO
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 that gross-to-net number, that really is made up of chargebacks and fees. Chargebacks mean governmental programs such as 340B, and fees are largely bona fide fees to distributors. We would expect that over time to increase as 340B participation increases. With respect to a target, I would not expect that to reach 20 percent; I would expect it to remain in the teens on that metric, but we'll have to see how that plays out. We are not planning at all to discount the drug. I don't think we've had any returns, and I think any returns will be negligible. Going forward, I would expect the components of the gross-to-net to be what they were in Q1: chargebacks and fees only.
Serge Belanger, Analyst (Needham)
Got it. And then regarding P&T approvals, clearly, you got some good traction through the end of the first quarter here with the numbers you gave us.
Gregory Demopulos, Chairman and CEO
Yes.
Serge Belanger, Analyst (Needham)
Curious when do you expect the rest of them to go through the P&T approval process? Are they already scheduled? And then 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, an NTAP, what kind of impact could they have on further uptake once they are in effect?
Gregory Demopulos, Chairman and CEO
Yes. 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, so we are really still very early in the process and the P&T committee approvals that we've seen are quite satisfying in that they are well ahead of what we would have expected in terms of timeline and number of approvals. Clearly, there is an urgency that's being recognized and manifested across the sites, with physicians and pharmacists recognizing the value of YARTEMLEA and moving quickly to make it available. There are centers that are approving access to the drug absent P&T approvals, but additional P&T approvals will certainly help that access, streamline it, and make it quicker and more efficient. With respect to when we would expect the large majority of them to have gone through the P&T process, I would expect most will be coming through in the next few months. On your second question about the J-code and the NTAP: the J-code certainly streamlines the billing and reimbursement process, and having the J-code awarded and going into effect on July 1 will be very helpful. Regarding NTAP, CMS has indicated in its proposed Inpatient Prospective Payment System rule that they support approval of NTAP for YARTEMLEA. We expect that will be finalized in the inpatient final rule in August, and assuming that is the case, it should become available for use on or very close to November 1. Both the J-code and the NTAP should obviously help with reimbursement, and when you have secured reimbursement that certainly helps with utilization. I'm frankly quite surprised by how broadly YARTEMLEA has been used in the absence of historical reimbursement, but once reimbursement becomes much more standard and well-recognized, that will drive front-end utilization as it should.
Operator, Operator
There are no further questions at this time. I will now turn the call back to Dr. Demopulos for closing remarks.
Gregory Demopulos, Chairman and CEO
All right. 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, Operator
This concludes today's call. Thank you for attending. You may now disconnect.