Omeros Corporation (OMER) Earnings Call Transcript & Summary

Good afternoon, and welcome to today's earnings call from Omeros Corporation. [Operator Instructions] 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 from 1 week from today. I'll turn the call over to Jennifer Williams, Investor Relations. Jennifer, you may begin.

Good afternoon, and thank you for joining the call today. I'd like to remind you that some of the statements that will be made on the call today will be forward-looking. These statements are based on management's beliefs and expectations as of today only and are subject to change. All forward-looking statements involve risks and uncertainties that could cause the company's actual results to differ materially. Please refer to the special note regarding forward-looking statements in the company's annual report on Form 10-K, which was filed today with the SEC, including the Risk Factors section for a discussion of these risks and uncertainties. Now I would like to turn the call over to Dr. Greg Demopulos, Chairman and CEO of Omeros.

Thank you, Jennifer, and good afternoon, everyone. We'll start with the corporate update and an overview of our fourth quarter and full year 2022 financial results followed by a more detailed financial summary. Joining me on the call today are Mike Jacobsen, Nadia Dac, Cathy Melfi and Steve Whitaker, our respective heads of finance, commercial, regulatory and clinical. Before diving into the details of our specific program updates and coming events, I'd like to spend just a few minutes on our financial strength that we expect will enable those events without the need for near-term shareholder dilution, continuing to position Omeros for success. To provide some background, in December 2021, we completed the strategic sale of the cataract surgery product that we developed and commercialized, OMIDRIA to Rayner Surgical for an upfront payment of $125 million, $31 million of retained receivables, substantial ongoing royalties on Rayner's net sales of OMIDRIA and the potential to receive a $200 million milestone payment by securing for OMIDRIA continuous separate payment of at least 4 years. The initial royalty rate on U.S. net sales of OMIDRIA was 50%, which represented nearly 80% of the total operating profit. Last September, we sold a portion of our future OMIDRIA royalty stream to DRI Healthcare and received $125 million in cash. Because DRI's annual royalties are capped and as a result, Omeros received any financial upside in the OMIDRIA royalty stream, the royalty sale was recorded as debt on our balance sheet and no income was recognized related to the sale. Then 3 months later, in December 2022, Omeros achieved the Rayner milestone, receiving $200 million plus interest in early February. Under our agreement with Rayner Surgical after achieving the milestone, the royalty rate that we now receive on Rayner's U.S. net sales decreased to 30%, which represents approximately 40% of total OMIDRIA operating profits. Nearly half of all cataract procedures in the U.S. are performed on Medicare Part B patients with surgical and facility fee payments administered by the Centers for Medicare and Medicaid Services, or CMS. Since OMIDRIA's market launch in the second quarter of 2015 through multiple CMS awarded and congressionally mandated pass-through periods and then qualifying under the non-opioid pain management exclusion from packaging, OMIDRIA has received continuous separate payment from CMS interrupted over those 8 years for a total of only 11 months, 9 months in 2018, following successful legislation extending pass-through and 2 months in 2020 after qualifying for CMS' non-opioid packaging exclusion. But separate payment repeatedly needed to be one. So we, together with physicians and surgical facilities could never rely on CMS providing separate payment for OMIDRIA long term. Despite this uncertainty, the drug to date has infused Omeros with effectively $1 billion in non-dilutive funding, fueling the development of our pipeline, while minimizing both outstanding share count and shareholder dilution. Now let's look at our financial results for both the fourth quarter and the year. Our net income for the fourth quarter was $128.7 million or $2.05 per share compared to $280.6 million or $4.49 per share for the fourth quarter of 2021. Both the current and the prior year quarters were significantly affected by OMIDRIA transactions that I just recounted, namely the December 2021 strategic sale of OMIDRIA and the December '22 achievement of the Rayner milestone. Looking only at continuing operations, our net loss for the fourth quarter of 2022 was $0.73 per share compared to $0.76 per share for the same quarter in 2021. Our cash burn for the fourth quarter of 2022 was $26 million. Omeros received $17.9 million in royalties from Rayner's OMIDRIA fourth quarter net sales of $35.8 million, a new quarterly record. Our net income for the full year 2022 was $47.4 million or $0.76 per share compared to $194.2 million or $3.12 per share in 2021. Our full year loss from continuing operations in 2022 was $182 million or $2.90 per share compared to a loss of $191.5 million or $3.07 per share in 2021. As of December 31, 2022, we had $195 million of cash and investments and $213 million in receivables, inclusive of the $200 million milestone payment. All of those receivables have now been collected. So in total, we had $408 million in cash, investments and receivables at December 31, 2022, to support ongoing operations and debt service. A good number of shareholders contacted us last week asking whether our corporate cash and investments were in any way exposed to Silicon Valley Bank, but to be clear, we do not have any assets on deposit with Silicon Valley Bank, nor do we have any other financial relationship with SVB or its affiliates. The $408 million now in hand provides Omeros the flexibility simply to pay off any or all of the $95 million of convertible debt that matures this November, while continuing to fund operations and advancing our multiple development programs well into 2025. Moreover, the recent [indiscernible] the Consolidated Appropriations Act of 2023 also known as the 2023 Omnibus Bill mandates that CMS continue to pay separately for non-opioid pain management drugs like OMIDRIA in ambulatory surgery centers or ASCs until at least 2028. While the majority of cataract surgery is performed in ASCs, approximately 20% of those procedures occur in hospital outpatient departments or HOPDs [indiscernible] address this as well, directing CMS to pay separately for drugs like OMIDRIA not only in ASCs, but also in the HOPD setting, beginning no later than January 2025. The assurance of long-term separate payment in both the ASC and HOPD settings now provides physicians and surgical facility administrators, the confidence that they can incorporate OMIDRIA into their practices and plan on being adequately reimbursed for delivering best care to their patients. We expect this increased certainty in CMS payment to result in meaningful OMIDRIA sales growth. Congressionally mandated long-term separate payment by CMS could also have a direct and positive effect on the other 2 major coverage systems for cataract surgery, Medicare Advantage and commercial insurance plans, driving expansion of separate payment across both of them, which would be good for ophthalmic surgeons and their patients. The fact that many Med Advantage and commercial plans are administered by the same payers, should accelerate this expansion. There are well over 4 million cataract procedures performed annually in the U.S. alone. As U.S. sales of OMIDRIA continue to grow, Omeros will continue to receive 30% of those revenues as royalties. Potentially further adding to our royalty stream, Rayner is planning to begin selling OMIDRIA outside of the U.S. later this year, resulting in 15% of any of those revenues also enuring to Omeros. Both the U.S. and international royalty rates paid to Omeros should remain [indiscernible] until the expiration of OMIDRIA patents, which are slated to be no sooner than 2033. So having laid out the current strength of our financial position, let's now turn to updates on Omeros' programs, beginning with narsoplimab in stem-cell transplant associated thrombotic microangiopathy, or TA-TMA. Following our appeal of FDA's complete response letter on our biologic license application or BLA, for narsoplimab in TA-TMA, in late 2022, we received guidance from FDA's Office of New Drugs, proposing a path forward to resubmit our BLA with additional analyses comparing response from our completed pivotal trial to a threshold derived from an independent literature analysis. Also requested was evidence of increased survival in our completed trial compared to an appropriate historical control group. We have identified and now can access robust sources of independent and historical response rates and survival in TA-TMA patients not treated with narsoplimab. Working with our regulatory and legal advisers led by [indiscernible] toward a rapid resubmission of our BLA, we have requested a meeting with the FDA's Division of Non-Malignant Hematology to discuss the details of our proposed analyses and to confirm the information required by FDA to support narsoplimab's approval. This will be a Type B meeting, so we expect it to occur in the first half of the second quarter. For European approval, we have initiated clinical trials assessing narsoplimab in pediatric patients with TA-TMA to fulfill our pediatric investigation plan agreed with the European Medicines Agency or EMA. We expect to complete the submission of our marketing authorization application to EMA after resubmission of our BLA. Since our last earnings call, we've seen continued and substantial activity in peer-reviewed publications and presentations directed to TA-TMA the lectin pathway and narsoplimab. An international group of leading transplanters recently published a systemic review of signs and symptoms of TA-TMA in transplantation and cellular therapy. And a second manuscript on TA-TMA diagnosis and treatment has been accepted for publication by the journal, Bone Marrow Transplantation. Presentation at the recent Annual Meeting of the American Society of Hematology detailed our clinical trial of narsoplimab in pediatric patients with TA-TMA and 2 additional abstracts on use of narsoplimab in TA-TMA have been accepted for presentation at the upcoming European Society for Blood and Marrow Transplantation. Stem-cell transplanters internationally are increasingly identifying TA-TMA in their transplant patients and recognizing it as an urgent and unmet medical need. National diagnostic and procedural billing codes now officially recognize TA-TMA as a discrete complication of stem-cell transplantation. This means that once there is an approved treatment for TA-TMA off-label use, which occurs now with C5 inhibitors, should be rightly curtailed, further driving use of any approved treatment. We believe that narsoplimab deserves FDA approval for the treatment of TA-TMA and we are committed to continuing to work with FDA to make that a reality. Also in our narsoplimab portfolio, our Phase III clinical trial in patients with IgA nephropathy remains on track to read out 9-month proteinuria data in the third quarter of this year. This is expected to form the basis for our BLA to be submitted to FDA, and we expect for our submission to European Regulators. Adding to a list of existing publications, a manuscript authored by a group of international experts on the role of the lectin pathway and the pathophysiology of IgA nephropathy, has been submitted to a leading peer-reviewed journey. IgA nephropathy represents a multibillion-dollar market opportunity. While FDA has recently approved for IgA patients in both a steroid and a representative of a new class of agents that target blood pressure, clinical experts do not see these as competitors, but rather as complementary to inhibitors of the complement system. There currently is no complement inhibitor approved for IgA nephropathy, and we aim to make narsoplimab the first. As we've discussed in previous calls, our Phase III program in atypical hemolytic uremic syndrome, or aHUS, remains a low priority. Enrollment has been challenging and due to what we and others see as a contracting commercial market for aHUS because of the increasing number of C5 biosimilars, we've diverted resources to other clinical programs within our complement franchise. At our labs in the University of Cambridge, collaborative work with multiple U.K. consortia in acute severe and long COVID is advancing. Dialogue is ongoing with relative branches of the U.S. government and with the resurgence of COVID and related diseases. There is continued interest from these agencies in accessing narsoplimab and funding narsoplimab-related activities. A manuscript directed the lectin pathway inhibition and well-established in vitro in animal models of both COVID and influenza-related acute respiratory distress syndrome, or ARDS, is being prepared for submission. The evidence supporting the central role of the lectin pathway and the utility of narsoplimab in these diseases is only increasing. This is being further highlighted within government agencies as the utility of vaccines under increasing scrutiny becomes more questionable, and the need for therapeutics that directly target the central pathophysiology of COVID and other causes of ARDS moves to the forefront. Now let's look at OMS1029, our long-acting next-generation antibody targeting MASP-2 and the lectin pathway. OMS1029 is complementary to narsoplimab, whereas narsoplimab is generally administered intravenously once weekly, ideal for acute or episodic treatment. Long-acting OMS1029 is designed for chronic use. Our strategy of developing OMS1029 is a long-acting follow-on to narsoplimab is to enable Omeros to control first-line therapies for the large majority of lectin pathway-related disorders. In January of this year, we completed dosing of all cohorts in the OMS1029 single ascending dose Phase I clinical trial. As predicted, given our experience with narsoplimab, OMS1029 was well tolerated with no safety concerns identified. The trial did deliver excitement though in that the pharmacokinetic and pharmacodynamic data demonstrate that OMS1029 effectively ablates lectin pathway activity and should do so even with markedly protracted dosing intervals of once-quarterly administration. Detailed results from the single ascending dose study of OMS1029 are planned for presentation at an upcoming scientific congress. Dosing in the OMS1029 multiple ascending dose study in healthy subjects is scheduled to start this summer. Wrapping up, our lectin pathway portfolio, we believe that we are very close to selecting a lead drug development candidate from our small molecule orally active, MASP-2 inhibitor program. Recent pharmacokinetic and pharmacodynamic data are compelling and safety data generated to date are clean. Together with our external advisers, including former heads of chemistry, pharmacokinetics and drug metabolism with GlaxoSmithKline and Merck, we are enthusiastic about these molecules and hope to select a lead compound next quarter. A successful orally dosed small molecule inhibitor of MASP-2 together with narsoplimab and OMS1029 should enable Omeros to control the gamut of diseases and disorders caused by dysregulation of the lectin pathway. We'll now complete the updates on our complement franchise with OMS906, our antibody targeting MASP-3. MASP-3 is the key activator of the alternative pathway of complement. As previously announced, we successfully completed a single ascending dose Phase I study of OMS906, evaluating both intravenous and subcutaneous administration in healthy subjects. The drug was well tolerated, and there were no safety signals of concern. Detailed clinical data from that study were presented in December at the Annual Meeting of the American Society of Hematology. Based on clinical data to date, we expect that we will be able to achieve once-quarterly dosing with OMS906, either intravenously or subcutaneously. This along with the other potential differentiating benefits of OMS906, should serve us very well in the competitive marketplace of alternative pathway inhibitors. Our clinical development strategy is to obtain rapid proof of concept data on the efficacy of OMS906 in multiple validated alternative pathway-related disorders, including paroxysmal nocturnal hemoglobinuria, or PNH, and complement 3 glomerulopathy, or C3G. On schedule, last December, we began enrolling treatment-naive PNH patients in one of our Phase Ib clinical trials evaluating OMS906, and dosing began early this year. Our second Phase Ib clinical trial, this one in PNH patients who have had an unsatisfactory response to the C5 inhibitor, ravulizumab, is also enrolling. We're scheduled to begin the first dosing of OMS906 in this study later this month once the ravulizumab monotherapy period has ended. The current development plan for OMS906 and PNH involves a pivotal program consisting of 2 trials, one in treatment-naive patients and one in patients who don't respond well to improve PNH therapy, both with relatively small numbers of patients similar to the numbers enrolled for Novartis' iptacopan and Apellis' pegcetacoplan programs. We've also initiated a Phase Ib clinical trial evaluating OMS906 in patients with C3G. Enrollment here is expected to commence next month with data available in the third quarter of this year. Here again, we're planning for relatively small study population similar to the number of C3G patients being enrolled by Novartis for iptacopan. Regulatory interactions in the U.S. and Europe are ongoing for OMS906 in both PNH and C3G. As discussed earlier, there is good evidence that MASP-3 and 906 could prove to be the premier target and drug, respectively, in the alternative pathway. The potential advantages of OMS906 over other alternative pathway inhibitors on the market or in development include safety, through a meaningfully decreased infection risk by not blocking the adaptive immune response, compliance and convenience with significantly better dosing profile and once-quarterly intravenous or subcutaneous administration and efficacy through greatly decreased risk and breakthrough of the underlying disease given that MASP-3 first is not an acute-phase reactant and that OMS906 has a long half-life, allowing MASP-3 to be blocked consistently and effectively. These advantages are well recognized by scientific and clinical experts across both academia and industry. The question that remains is whether MASP-3 inhibition and specifically OMS906 can demonstrate efficacy in any alternative pathway disorder. If it does, then the widely held expectation is that OMS906 will be efficacious across the full scale of alternative pathway-associated diseases and disorders. This is particularly true if we demonstrate efficacy in PNH, which because of the severity of the disease, sets a very high bar for alternative pathway inhibition. But efficacy in any alternative pathway disorder should readily allow a value calculation of the OMS906 program based on predicate alternative pathway drugs in programs such as C3, Factor B and even C5 inhibitors. Should OMS906 demonstrate efficacy, we're confident that the safety, compliance and convenience and efficacy advantages that I described just a minute ago, would significantly differentiate OMS906 from those predicate alternative pathway inhibitors and others in development. Again, based on the science and evidence to date, we believe that MASP-3 is the premier target. And by extension and because of its attributes, OMS906 has the potential to be the premier drug in the alternative pathway market. So we look forward to sharing publicly clinical data from our OMS906 program. Turning now to OMS527, our PDE7 inhibitor program. Discussions continue regarding third-party funding for continued development of OMS527 as a treatment for addictive disorders. As has been widely and frequently broadcast, addiction is an enormous and worsening problem in the U.S. and worldwide. In the U.S. alone, in 2019, tangible measured cost of substance abuse were $0.5 trillion. With intangible costs such as loss of life, injury, reduced quality of life, all of those estimated at a staggering $3.2 trillion annually. With the Centers for Disease Control and Prevention, reporting that 1 in 7 Americans, 12 years of age or older have experienced a substance use disorder. A therapeutic that could treat the cause of abuse could change the lives of tens of millions of patients just in the U.S. We look forward to securing external funding and moving ahead with further clinical development of OMS527. In addition to the wide field of addiction and compulsion disorders, Omeros also controls broad intellectual property directed to PDE7 inhibition for the treatment of movement disorders. With collaborators at Emory University, we're evaluating OMS527 as potential treatment for L-DOPA-induced dyskinesias, or LID. These dyskinesias are crippling, involuntary movements in Parkinson's patient in part and ironically by prolonged treatment with L-DOPA, the most prescribed and the most effective therapy for Parkinson's. More than 10 million patients are living with Parkinson's worldwide and reportedly 50% or more of those treated with L-DOPA suffer from LID. Only one drug, extended-release amantadine is approved for the treatment of LID and it has limited efficacy with multiple significant adverse side effects. Here again, LID represents a large unmet patient need and a substantial market opportunity. Data to date in a clinically predictive primate model of LID have been encouraging. We await data from one additional primate, which took longer to develop LID than anticipated by our Emory collaborators. Treatment with our PDE7 inhibitor is underway and data are expected next month. We'll close the update today with our immuno-oncology programs. These are platform programs for both cellular and molecular therapies for cancer, all are derivatives of our work on GPR174, our proprietary target in cancer immunity. For cellular therapies, we've developed and are evaluating novel approaches for both CAR T and adoptive T-cell therapy. We've identified specific T-cell signaling pathways, which once inhibited, significantly and preferentially enhance the expansion of memory T cells that distinctively recognize and efficiently kill tumor cells. Our team is validating these novel approaches and establishing a broad [indiscernible]. We believe that the proprietary cellular technologies could markedly improve response rates for cancer patients, receiving either engineered or native T cell therapies for both liquid and solid tumors. On the molecular front, we have developed novel biologic platforms to target specifically and kill cancer cells. We expect that some of these biologics will function as therapeutic vaccines against a broad range of tumors. Successful development of therapeutic cancer vaccines are widely pursued, have proven difficult to achieve with the current industry approaches, inducing only transient and ineffective immune responses. We believe that we've overcome this challenge. Having now engineered novel molecules that combine tumor antigens with a potent adjuvant, these combinations show high levels of killing in cancer cells and demonstrate the potential to transform the treatment of both solid tumors and hematological cancers. Here again, we're constructing a broad intellectual property [indiscernible] around these multiple immunotherapy platforms. With that, I'll turn the call over now to Mike Jacobsen, our Chief Accounting Officer, who will go through a more detailed discussion of the financial results for the fourth quarter of the year. Mike?

Thanks, Greg. As Greg discussed, in December of last year, Rayner acquired OMIDRIA and associated business operations. The sale required us to restate our financial statements for all periods into continuing operations and discontinued operations. Our net income for the fourth quarter was $128.7 million or net income of $2.05 share compared to a loss of $17.5 million or $0.28 per share in the third quarter of '22. The fourth quarter includes the $200 million milestone we earned from Rayner in December, which is included in discontinued operations. If we look at just continuing operations, our net loss for the fourth quarter was $0.73 per share compared to a net loss of $0.87 per share in the third quarter, a $14 improvement. At year-end, we had $195 million of cash and investments on hand and $213 million in receivables, all of which we have collected. The $213 million year-end receivable balance includes the $200 milestone payment as well as the OMIDRIA royalties for November and December, which are due 60 days after respective month ends. We, therefore, have approximately $408 million in cash available for operations and debt service when you add the cash and investments together with the receivables. Cost and expenses from continuing operations for the fourth quarter were $40 million, which is a decrease of $10.6 million from the third quarter. The decrease was primarily due to manufacturing commercial narsoplimab drug substance in the third quarter, which we expected given that we do not have FDA approval. As we finalize our path forward for TA-TMA, we continue to gauge our narsoplimab's marketing spend until the timing of FDA approval is clear. Interest expense for the fourth quarter was $7.9 million compared to $4.9 million in the third quarter. The $3 million increase is due to interest on the DRI agreement, which we entered on September 30 of this year. Now let's look at OMIDRIA royalties. As I've mentioned previously, royalties earned are recorded as a reduction in the OMIDRIA contract royalty asset on our balance sheet. Since the sale of OMIDRIA in December of 2021, we have been receiving royalties of 50% of U.S. net sales of OMIDRIA. Upon the achievement of the $200 million milestone on December 29, 2022, OMIDRIA royalties decreased to 30% of U.S. net sales. The 30% royalty equates to approximately 40% of U.S. OMIDRIA operating profit, considering the OMIDRIA operating expenses we no longer have to pay. The 30% royalty rate extends for the duration of the relevant patent terms, which we expect to be at least through 2033. For the fourth quarter, our 50% royalty on Rayner net sales was $17.9 million, on sales of $35.8 million. The $35.8 million is a [indiscernible] million increase in net sales over Q3 and establishes a new all-time high for a OMIDRIA quarterly sales. Income from discontinued operations in the fourth quarter includes 4 key components. The $200 million milestone payment, $4.9 million of interest earned on the OMIDRIA contract royalty asset, $26.2 million of expense due to the remeasurement adjustments to the OMIDRIA contract royalty asset, and state income tax expense of $4 million. We do not owe any federal income tax due to the utilization of a portion of our outstanding net operating losses. The remeasurement of the contract royalty asset is primarily due to the reduction of future OMIDRIA royalties when the rate was reduced from 50% to 30% of net sales. Now let's take a quick look at our first quarter expected results. We expect overall operating costs from continuing operations in the first quarter to remain relatively consistent with the fourth quarter. Interest income should be nearly $3 million, and interest expense for the first quarter should be consistent with the fourth quarter at approximately $8 million. Income from discontinued operations should be in the $7 million to $8 million range. With that, I'll turn the call back over to Greg. Greg?

Thanks, Mike. Operator, why don't we open the call to questions.

[Operator Instructions] And our first question comes from Colin Bristow from UBS.

Congrats on all the progress. So on the TMA filing and the regulatory path, I know you anticipate a meeting with the FDA in 2Q. Have you had any additional conversations with the agency or any additional feedback since the last update you provided, which I think was in November? And then with regards to this upcoming FDA meeting, what are the primary questions or points of discussion you're looking to cover? Is it -- since it felt that in last feedback from FDA, there was a sort of fairly prescriptive kind of path to what is required from you to restart the process?

Colin, thanks for the question. First, we don't discuss specific timing of discussions or details of discussions with FDA. But with respect to your second question, the purpose of the meeting, I think, as we said, is to just confirm and make sure we're all clear on whether what we are proposing as analyses will be acceptable. So this is really to reach agreement with FDA as to what needs to be done, what will suffice with respect to those analyses so that we can deliver to FDA specifically what they need so that we can get this drug approved. I mean, Cathy, do you want to add anything to that?

No, I think that pretty much covers that. As Greg said, we will be working with FDA to go over our proposal based on the feedback that we've received to date. And we want to make sure that what's in our resubmission is what's needed to approve the drug.

And our next question comes from Steve Brozak from WBB Securities.

Just one quick one. Can you go into and give us much detail on your diagnostic collaboration with Cambridge and what can you tell us about what kind of data you're seeing there? And what are the ramifications from that? And I'll jump back in the queue.

Yes. We'll be publishing more data, Steve, coming out of Cambridge, so I don't want to preempt that. But with respect to the diagnostics specifically, what we have identified is a pattern of complement factor changes that occur with severe acute COVID and even moderate COVID but hospitalized COVID patients that specifically link to the lectin pathway. And we are in discussions with government agencies around. That panel of assets that we are working through. This may also have applicability to long COVID [indiscernible], but it is, I think, currently premature to make any definitive statements about that.

And our next question comes from Greg Harrison from Bank of America.

It's Mary Kate on for Greg. Congrats with the milestone payment. I guess looking at the narsoplimab program here in IgAN and given the Phase III data expected, what are your commercial expectations for narsoplimab, if approved in this indication?

Well, we think the opportunities for narsoplimab is a lot. As I said, the IgAN market is a large market. It's a multibillion-dollar opportunity as you know. And what's been approved as been in orally -- orally available steroid, one that works primarily within the gut. And an agent that is another approach to blood pressure control. But what we're talking about with narsoplimab specifically, is an anti-complement agent. And we think the utility of that could be substantial, particularly in patients with high proteinuria or patients with high levels of protein spillage in the urine. And when I say that, I mean those patients somewhat arbitrarily, but those patients who have 24-hour urine proteins of 2 grams or more per day. We think that there is a very large opportunity for the treatment of those patients as well as those with lesser degrees of proteinuria, and we think that certainly, there's a need for complement inhibition and specifically lectin pathway inhibition. As I think we've discussed before, lectin pathway inhibition is important, not only at the glomerulus but also in the tubular endothelium. And as you know, that is where all end-stage proteinuric renal diseases pass. So really, if you can affect the tubular interstitial, you are effectively treating or potentially treating all proteinuric renal diseases. So we think the opportunity is very large.

And one moment for our next question. And our next question comes from Brandon Folkes from Cantor.

I just want to come back to that first question around narsoplimab and the TA-TMA meeting with the FDA. Is there a way to contextualize sort of the level of work you've done ahead of this meeting? And what I mean by that is if you do have a meeting [indiscernible] the approach to sort of addressing the CRL, is this something we should expect a submission relatively shortly thereafter? Or is it more just going to agree on an approach and then it could be a couple of months or quarters of work behind that?

Yes. Let me first say that in the prepared comments, I think I made it clear that we've identified and now can access the sources of information that we need or we believe we need them to address FDA's concerns. So I think it would be premature though on the front-end of that FDA meeting to talk about how long it will take us to satisfy FDA. Let's get through the meeting first, and then I think we can speak more definitively about that. Otherwise, it's pure speculation. But I think part of your question is what have we been doing. And certainly, in the meantime, since our last public statement around this, there's been a tremendous amount of work being done. One, in identifying those sources of information; two, obtaining access to those. Certainly, we aren't running analyses upfront because we want to make sure that we with FDA agree on one analysis we're going to run. But then I think, running them. If we're all in agreement on what we're doing, should not be a lengthy process. But let me see, again, I'll ask Cathy and/or Steve, if you have any other comments on this.

Thanks, Greg. Yes, we have been working quite a bit since the last update. And also, as Greg mentioned earlier, we're working with our real regulatory consultants and working closely with them to make sure that we're providing the best information that we can and trying to set ourselves up for success.

Great. That's very helpful. One more, if I may. You've done a tremendous job shoring up the balance sheet. And I think the commentary in the press release was sort of funded through at least 2025. Can you just give us a sense of which programs you include in that runway? Is that your sort of the whole breadth of the pipeline? Or just how you're thinking about kind of maybe focusing on some? Anything you can do to speed up these trials just given your strong balance sheet?

Yes. Sure. Thanks again, Brandon. Well, certainly, our focus on narsoplimab is a high priority. Similarly, our focus on 906, I think as we made clear, we began enrolling last December, we began dosing in January. We are pushing hard on that program. We think that that's going to be a very important program not only for us, but for patients with alternative pathway disorders. So that's a priority. When we kind of march down, you look at OMS1029, which is our backup to narsoplimab, that program is sailing through. Everything looks good there. Similarly, the small molecule program, let's see if we select. If we select a development candidate next quarter, we'll be looking at advancing that. But as you know, that's really a lot of pre-IND work, and that's pretty contained with respect to costs. 527, we're looking for external funding. And once we have that, assuming we get it, we expect that to fund clinical work and further development. If we turn over a positive card on the levodopa-induced dyskinesias, that's another area that we would consider a clinical trial. But again, that would be limited in size first. It would be proof of concept, so costs would be pretty contained. Then when you look at our immuno-oncology programs, those are preclinical, but we hope to, over the coming months, be able to start to move one or more of them into IND-enabling work, which, again, those costs are pretty contained. So I think I've answered your question, but let me be very specific about it. All of the programs I've just mentioned are laid out there for the budget and fall within what we're doing all the way well into 2025. Again, based on where we see success, we can always push the hammer down even more on those specific programs. But we are looking for additional revenue beyond OMIDRIA coming in and continuing to drive further development of the pipeline.

And our next question comes from Serge Belanger from Needham & Company.

A couple of questions for us. The first one on the ARTEMIS Phase III trial that I think is expected to read out in the third quarter of this year. Greg, I think you mentioned that you expect this trial to support the BLA filing. Just curious when you would expect the BLA filing, assuming that we get positive results in the third quarter? What kind of other data would you need to complete that filing?

Yes. Remember what we -- thanks, Serge. What we're going to be looking at as the primary endpoint is proteinuria data. So if those data are positive, and we hope and frankly, expect that they will be, but we need to see those data. When we see those, assuming they are positive, we would be moving quickly to put those data into the BLA. The safety data, all of the other components of the BLA are already being pulled together. So I think on timing, conservatively, I would look at a 4- to 6-month time frame from data to submission. But let me look to Steve and to Cathy to see if there are any other comments.

No. I think we've identified everything that go in the BLA and have plans together at all. So try to put in quickly.

The top line data -- once we have the top line data, that kind of what triggers the pre-BLA meeting with FDA. And so OMIDRIA, I concur with the timing that Greg has proposed.

So there would be no issues in having 2 separate BLA filings, one for TA-TMA and another one for IgA nephropathy?

Yes. You're talking about, I think, resource allocation and workload. We -- remember that we're looking for Q3 data on IgA. So we would expect that they would blend well. But Steve, this is partly your group as well. So why don't you address this?

We've identified resources we need so they can run in parallel, and there's overlap between the 2 as well. So I wouldn't see any one blocking the other.

And then a couple on OMIDRIA. Now that the you've gotten the milestone payment and the royalty rates knocked us down from 50% to 30%. Does that have any implication for the DRI royalty agreements?

Yes. Let me just answer that first. No, I think our agreement with DRI, frankly anticipated. Our success in achieving a milestone and DRI was and is very aware of that 30%. But we also -- all of us, I think DRI included expect overall sales to continue to increase with the legislative successes that have been achieved for all non-opioid pain management drugs, and also as we start to focus on, I hope, Med Advantage as well.

And the last question, your partner Rayner now has a lot more visibility on the overall coverage of OMIDRIA. Do you expect they'll increase your commercial support for the product going forward?

That's a great question for Rayner. I would expect they would. You now have secure long-term separate payment in the ASC. You also have HOPD payment beginning in 2025, January 1, 2025. That's another 20% of the market. And so I would expect that they would be capitalizing on the broad support of the product and ramping up to do the same. But let me see, Mike, any comments on that?

No. I think Rayner's obviously looking at it. They are very aware that we've gotten the milestone and preserve the long-term payment. And the HOPD side increases the potential there as well. So I think Rayner is really aware of the opportunities they have [indiscernible].

There's a tremendous opportunity as well on the Med Advantage side. And I think I'm sure that Rayner realizes that and is focused as they should be on expanding Med Advantage payments, not just coverage, but payment. And there are ways, I think, that the congressional action can carry through, and we've looked at that as well, that, that can carry through to Med Advantage and help educate the Med Advantage payers, which often are the same payers as commercial as to why they should be separately paying for OMIDRIA in the same way that Congress has mandated CMS did.

And I am showing no further questions. I would now like to turn the call back over to Dr. Demopulos for closing remarks.

All right. Thank you very much, operator. Once again, thank you, everyone, for joining us today. As I think you can see, and as I think we were just discussing with some of the analysts, Omeros is well positioned financially to develop the deep pipeline of assets that we control. So with multiple and frequent near and midterm milestone events, the financial strength that Omeros now has really despite the tumultuous times globally and macroeconomically, will allow us to remain focused throughout 2023 and beyond on really bringing life-saving products to patients and value to our shareholders. And we'll continue to keep you updated on our progress. As always, we appreciate your continued support. Have a good evening.

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