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spk08: Good afternoon and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in listen-only mode. After the company's remarks, we will conduct a question and answer session. Please be advised that this call is being recorded at the company's request and the replay will be made available on the company's website for one week from today. If you require operator assistance, please press star then zero. I'll turn the call over to Jennifer Williams, Investor Relations for Omeros.
spk02: 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 quarterly report on Form 10Q, which was filed today with the SEC, and the risk factor section of the company's annual report on Form 10K for a discussion of these risks and uncertainties. Now I would like to turn the call over to Dr. Greg Zimopoulos, Chairman and CEO of Omeros.
spk10: Thank you, Jennifer, and good afternoon, everyone. We appreciate you joining us for today's call. We'll start with a corporate update and an overview of our second quarter 2022 financial results, followed by a more detailed financial summary. Joining me on the call today are Mike Jacobson, Nadia Dock, Kathy Melfi, and Steve Whitaker, our respective heads of finance, commercial, regulatory, and clinical. We'll start with an update on our MASP2 program and specifically narsoplimab and stem cell transplant-associated thrombotic microangiopathy, or TATMA. In the first quarter of this year, we had a type A post-action meeting with the FDA review division for our biologics license application, or BLA. Following the receipt of the official minutes of that meeting, we decided in consultation with our regulatory and legal advisors to pursue formal dispute resolution. The dispute resolution process allows a sponsor to appeal a decision made at the division level to a higher deciding authority, which in our case is the Office of New Drugs, or OND. As previously reported, our dispute resolution request was submitted to FDA in June. The request comprised a detailed briefing document that we believe presents to OND a compelling case across all of the components, clinical data, regulatory history, regulatory precedent, and literature, that narsoplumab should be approved for use in TATMA based on our BLA as originally filed. Following the submission of that briefing package as part of FDA standard procedures for dispute resolution, We met with OND last month. The deciding official was well prepared and familiar with our BLA and with our briefing package. We were joined at the meeting by several leading experts in stem cell transplantation. At that meeting, FDA does not typically provide any indication of how the dispute resolution will be decided, and our meeting was no exception. We're currently awaiting a decision which, unless OND determines it requires additional time, should be rendered this month. Once received, we'll share FDA's decision publicly with our shareholders and the investor community. Let's turn now to narsoplimab for the treatment of IgA nephropathy. We continue to advance enrollment in our Phase III Artemis Igand trial, and the nine-month proteinuria data are scheduled to read out by mid-next year. We look forward to making those data publicly available. Our narsoplumab Phase III trial in atypical hemolytic uremic syndrome, or AHUS, is also ongoing, but as we've previously reported, it's prioritization, and as a result, its resource allocation is below those of our other complement programs. We're also evaluating narsoplumab as a potential therapeutic both for acute severe COVID-19 and for long COVID, also known as post-acute sequelae of SARS-CoV-2 infection, or PASC. As new variants of SARS-CoV-2 continue to emerge in vaccines and the current antivirals, are proving less effective than hoped, the need for better COVID-19 therapeutics remains and arguably continues to grow. Narsoplimab was part of the I-SPY COVID-19 platform trial sponsored by QuantumLeaf Healthcare Collaborative, which has evaluated now multiple agents as potential therapies for COVID-19. To date, no agent in the I-SPY trial has been publicly reported to show a benefit over standard of care. We continue to look forward to Quantum's disclosure of the narsoplamab results. The important role of complement and specifically the central role of the lectin pathway in both acute COVID and PASC is increasingly the focus of publications from leading research groups internationally. The OMEROS teams in the UK at the University of Cambridge and in Seattle recently added groundbreaking work to this effort, publishing manuscripts by Ali et al. in Frontiers in Immunology and by Lynch et al. in Clinical and Translational Medicine. Together, these publications describe our discoveries related to the pathophysiological mechanism of severe COVID-19, specifically that patients with severe COVID-19 early in disease show marked complement consumption, which is driven by lectin pathway hyperactivation. It's this hyperactivation of the lectin pathway that leads to secondary hypo complementemia and loss of complement mediated protection against infection. The result is increased risk of clinically severe infections, which are known to be a common cause of morbidity and death in COVID-19. So where does narsoplumab fit in? Well, narsupramab inhibits this complement consumption and restores complement function and bactericidal activity, thereby preventing risk of secondary infection. We've now evaluated longitudinal serum samples from over 400 acute severe COVID-19 patients from multiple UK government-funded consortia. At ICU admission, effectively, all sera of patients with severe COVID-19 showed elevated levels of MASP2C1 inhibitor complex, which is a marker of lectin pathway functional activity, low CH50 levels, a measure of overall complement functional activity, and residual elevated levels of the anaphylatoxins C3A, and C5A. A subset of these patients had very low antibody levels at ICU admission, meaning that complement activation and consumption in acute COVID-19 are antibody independent. Collectively, these data indicate that the lectin pathway is the key driver of complement hyperactivation in acute COVID-19. Based on these data, we're developing a multiplex high throughput assay platform as a commercially available tool for hospitals and physicians to reduce morbidity and mortality by identifying COVID-19 patients at risk for becoming severely ill. The clear implication is that these identified patients would then benefit from treatment with narsoplumab as soon as the consumptive biomarker profile is seen. Let's now discuss more broadly our MASK2 program, which as of this week has two molecules in clinical trials, narsoplumab and OMS1029, our long-acting second-generation MASK2 antibody. The first two subjects have now been dosed in our phase one trial evaluating OMS1029. Dosing for OMS1029 is expected to be once monthly to once quarterly, delivered subcutaneously or intravenously. Designed to be complementary to narsoplimab, OMS1029 should enable us to pursue lectin pathway-driven indications for which longer duration dosing would be a particular advantage. We're also making good progress on our small molecule MASP2 inhibitors. These will be orally administered and we're working to add an oral MASP2 inhibitor to our clinical portfolio as soon as possible. Now let's turn to Omidria and a high level overview of our financial results for the quarter. As previously discussed, last December, O'Meara's completed the strategic divestiture of its commercial ophthalmic drug, Omidria, to Rainer Surgical. The transaction with Rainer required us to reclassify all historical Omidria revenue and expenses as discontinued operations and to record the royalties earned as a reduction from the Omidria contract royalty asset on our balance sheet. Our royalty rate for U.S. net sales of Omidria is currently 50 percent, which equates to more than 70 percent of the operating profit. For the second quarter, Raynor reported Omidria net sales of $34.5 million, a new all-time high. This eclipses our previous high of $34.2 million for quarterly Omidria revenues and represents a 25% increase over Rainer's net sales of Omidria for the first quarter of 2022. Our 50% royalty on Rainer net sales for the quarter was $17.2 million. Given the required reclassification of Omidria revenues and expenses, our revenues for the second quarter were reported as zero And our net loss from continuing operations was $41.7 million compared to $50.2 million in the prior year quarter. Our overall loss for the current quarter was $30.8 million or 49 cents per share compared to $28.6 million or 46 cents per share in the second quarter of last year. Our non-cash expenses were $3.7 million or $0.06 per share for the current quarter and $3.9 million or $0.06 per share for the prior year quarter. As of June 30, 2022, we had $122.6 million in cash and investments on hand available to support ongoing operations. So in total, our change in cash and investments from the end of the first quarter to the second quarter is a decrease of $19.7 million. In addition, we have an additional $14.5 million of receivables representing primarily royalties to be paid to Omeros by Rainer for Omidria sales for May and June. Omidria royalties are received monthly by Omeros within 60 days of being earned. We also have $150 million at the market sales agreement, which we have not used. During the quarter, we continued to work closely with Raynor to ensure a smooth transition of the product, the teams, and all operations with minimal disruption to customers. The transition has gone well and we expect to complete it this quarter. We're encouraged by the quarter-over-quarter growth in OMIDRIA sales. We expect that the positive momentum will be further boosted by the proposed 2023 rule governing the outpatient prospective payment systems issued by CMS last month and reconfirming that OMIDRIA qualifies for separate payment under the non-opioid pain management exclusion when used in ambulatory surgical centers or ASCs. We appreciate CMS's commitment to continue providing access to Omidria for Medicare patients and their physicians. We're also pleased that as part of the proposed rule, CMS solicited public comment on potentially expanding the exclusion beyond the ASC setting to pay separately for non-opioid surgical drugs in hospital outpatient departments or HOPDs. We support this expansion as approximately 20% of cataract procedures are performed in HOPDs and cataract surgery patients deserve access to Omidria regardless. of whether they undergo surgery in an ASC or in an HOPD. Under the terms of the Raynor transaction, Omeros is also eligible to receive a $200 million milestone should, before 2025, separate payment be secured for Omidria for a continuous period of at least four years. Congressional passage of the Non-Opioids Prevents Addiction in the Nation Act, or the No Pain Act, would trigger this milestone payment for Omeros. The No Pain Act would provide separate payment for non-opioid pain management drugs like Omidria in both the ASC and HOPD settings. Leading the charge, Voices for Non-Opioid Choices continues to advance the No Pain Act and has assembled an impressive coalition of major medical societies, patient advocacy groups, and prevention and recovery organizations across the country in support of the legislation. The bill has strong bipartisan and bicameral support with sponsors and co-sponsors now numbering 49 in the Senate and 113 in the House of Representatives, roughly equally split between Democrats and Republicans. These senators and representatives include chairpersons and key members of relevant committees representing a diverse group of congressional caucuses. Passing the No Pain Act is the right thing for patients and for the country, and we expect that given the bill's broad-based and bipartisan support in both chambers. The No Pain Act has a good likelihood of becoming law in this Congress, or early in the next. Looking at the sales trajectory for Omidrea, we expect that the drug will continue to provide us with meaningful cash flow from royalties in both the near and long term. The non-dilutive Omidrea revenue stream helps to defray significantly. the costs of developing our pipeline programs, including our complement franchise of MASP2 and MASP3 inhibitors. Just as we have done for MASP2, we continue to build a dominant intellectual property position around MASP3, the key activator of the complement system's alternative pathway. Let's now turn to OMS906, our lead MASP3 inhibitor. Having successfully completed a Phase I study in healthy subjects, we're preparing to initiate enrollment in a trial evaluating OMS906 in patients with paroxysmal nocturnal hemoglobinuria, or PNH, who have an unsatisfactory response to the C5 inhibitor, rabulizumab. In late July, OMS906 received orphan drug designation from FDA for the treatment of TNH, the benefits of which include seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees. Awareness of our OMS 906 program is growing within the scientific community. We'll be presenting preclinical data on OMS 906 at the European meeting on complement and human disease later this month in Bern, Switzerland. And the results of our phase one trial have been submitted for presentation at a major congress later this year. We expect that OMS 906 could hold significant advantages over other agents approved. or in development for alternative pathway-related disorders. These advantages are expected to include decreased infection risk and a convenient dosing profile, with administration as infrequently as once monthly to once quarterly. Importantly, unlike other targets in the alternative pathway, MASP3 does not appear to be an acute phase reactant. An acute phase reactant increases in circulating concentration in response to inflammation in the body. That inflammation can be as simple and common as the flu. And the result is that dosing of a drug targeting an acute phase reactant might no longer be effective, resulting in breakthrough disease. Because MAS3 is not an acute phase reactant, background inflammation has no effect on its concentration or on the dosing of OMS906, greatly mitigating that risk of disease breakthrough. Given these expected advantages, we're focused on obtaining efficacy data with OMS906 as quickly as possible. So in addition to initiating our Phase 1b study of OMS906 in PNH patients who have had an unsatisfactory response to ravulizumab, we're expanding our OMS906 program to include trials evaluating OMS906 in treatment-naive PNH patients and in C3 glomerulopathy patients, as well as in one or more related indications. We're making good headway on this and are targeting data that demonstrate efficacy of OMS906 in these diseases by early 2023. The importance of alternative pathway inhibition is well understood, as is the commercial viability of agents successfully inhibiting the alternative pathway. If we demonstrate efficacy of OMS906 and alternative pathway diseases like PNH and like C3G and the safety dosing and or biological advantages that I just described prove to be accurate, which we expect they will, the value created around OMS906 should be compelling. Although we continue to prioritize our complement clinical programs over those of our phosphodiesterase or PDE7 inhibitor program, OMS527, discussions are ongoing to access third-party funding to continue development of OMS527 for addictive disorders. In addition to our work in addiction, Researchers at Emory University are evaluating in clinically predictive primate models the potential of our PDE7 inhibitors to improve L-DOPA induced dyskinesias. More than 50% of Parkinson's patients develop dyskinesias following prolonged L-DOPA treatment. Our existing patents broadly cover this indication and we look forward to seeing the final dyskinesia data early next year. If positive, we expect that we would have another viable and large commercial opportunity for OMS527. I'll close the update today with our immuno-oncology programs in which we're evaluating a number of novel molecules to treat cancers. To date, immuno-oncology primarily has been focused on cell surface checkpoints. We're taking a different approach, developing intracellular target inhibitors that optimize T-cell conditioning to yield both potent tumor killing and a more sustained antitumor response. Our technology involves a combination of inhibitors of GPR174, adenosine receptors, and other targets to limit the negative impact of certain pathways on T cell function. We believe that our novel approach has the potential to improve response rates for patients receiving either engineered or native T cell therapies for liquid and solid tumors. And we're continuing to explore the application of this technology to improve human CAR T cell therapies. Across these landscapes of both therapeutics and adoptive T-cell therapies, we're building broad patent protection. With that, I'll hand the call over to Mike Jacobson, our Chief Accounting Officer, for a more detailed description of our second quarter financial results. Mike?
spk01: Yeah, thanks, Greg. As Greg briefly discussed, on December 23rd, Raynor acquired Omidri and Associated Business Operations. The sale required us to restate our financial statements for all prior periods into two components. One, continuing operations, and the second, discontinued operations. This means that all historical amid rear revenue and operating expenses are shown in a single line on our income statement as discontinued operations. All of our other activities are included in continuing operations. The immediate transaction includes royalties on worldwide sales. Omaros will continue to receive royalties of 50% on net sales of Omidria in the U.S. until the early of either January 1, 2025, or the payment of the $200 million milestone. Thereafter, we will receive a 30% royalty on U.S. net sales for the duration of the relevant patent terms. which extend out to at least 2033. We will also receive a 15% royalty on any non-U.S. net sales of amidria over the life of the relevant tax. Excuse me. From an overall standpoint, considering the U.S. royalties and our reduction in operating expenses, we will receive more than 70% of the U.S. operating profit when royalties are 50%, and over 40% when the royalties is at 30%. Turning to our actual results, our net loss for the second quarter was $30.8 million, or 49 cents per share. This compares to a $33 million loss, or 53 cents per share, for the first quarter of this year. Our non-cash expenses for the quarter were $3.7 million, or 6 cents per share. As of June 30, 2022, We had $122.6 million of cash, cash equivalents, and short-term investments available for general operations. This is a $19.7 million decrease from our report at the end of March of this year. We also have $14.5 million in royalty and trade receivables, which will be fully collected by the end of this month. In addition, we have the at-the-market sales agreement that allows us to sell from time to time up to $150 million of our common stock. Costs and expenses from continuing operations for the second quarter were $41.7 million, which was an increase of $2.2 million from the first quarter. We continued to gate on our SOPLMAB sales and marketing spend until the timing of the FDA approval is clear. Additionally, we continued to expense any Nersoplumab manufacturing costs until timing of approval in the U.S. is certain. Interest expense for the second quarter was $5 million and consistent with the previous year quarter. Now let's look at discontinued operations. In the second quarter, the actual royalties earned from ambidious sales were $17.2 million dollars. an increase of $3.4 million from the first quarter of this year. The royalties earned were recorded as a reduction in the Omidria contract royalty asset on our balance sheet. Additionally, we recorded $10.8 million of income in discontinued operations in our income statement, recognizing for accounting purposes the interest earned on the Omidria contract royalty asset and remeasurement adjustments. Now let's look at the expected third quarter results. We expect overall operating costs from continuing operations in the third quarter of 2022 to increase modestly from those of the second quarter due primarily to the timing of some planned research and development activities. Interest expense for the third quarter should be consistent with the second quarter at approximately $5 million. Income from discontinued operations should be in the $8 to $9 million range. With that, I'll turn the call back over to Greg. Greg?
spk10: Thanks, Mike. Operator, would you please open the call to questions?
spk08: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you'd like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Greg Harrison with Bank of America. Please go ahead.
spk05: Hey, good afternoon. Thanks for taking the question. So on the narsoplimab IGAN program, will you announce when the trial is fully enrolled? I'd assume that may be close. That's the nine-month date. It will be mid-next year. And then where would you expect to see narsoplimab used in this indication? Is there a certain group that could be more amenable, or are you expecting broad use? And how does the existence of one or maybe even two approved therapies by the time you would launch impact your strategies?
spk10: Yes, I don't expect that we will be announcing when enrollment is complete, but I think, excuse me, you're correct, Greg, in that we are close. With respect to where we would use it, I mean, I think that the data that we've shown so far look to be generally applicable across IgA nephropathy in general. The bulk of our data, as you know, having seen the phase two data, are in high protein spillers. So those who are spilling more than two grams per day of protein. But, you know, I think, again, we are guardedly optimistic that the applicability of the product will be broad. But again, let's see the data. Steve, any additional comments?
spk06: I guess I'd say that it's important to remember that despite the fact there'd be potentially two other products on the market at that time, that the improvements we've shown have been greater than what they reported, and this does look like a first-line therapy, at least for a large number of patients.
spk10: To Steve's point, as you look, the magnitude of proteinuria reduction with narsoplumab shown to date has been a multiple of what's been shown by other products. But again, let's look at the data, and then I think that will help guide us.
spk05: Okay, great. Thanks for taking the question.
spk08: Thanks, Greg. The next question comes from Steve Brozak with WBB. Please go ahead.
spk09: Thanks for taking the questions. There are two I've got. One, I know you can't say anything about FDA, but I do want to know about items around Narsupplamab, for instance, drug availability and anything else that you can give us any kind of clarity on around Narsupplamab. And I've got a question on Imidria after that. Thank you.
spk10: Sure. With respect to drug availability, Steve, we have sufficient drug for a successful launch. Preparations are in place for a successful launch. So I think with respect to all of the components to which you're referencing, I think we're in good shape. But let me ask Nadia if she'd like to add anything to that.
spk11: Well stated, Greg. I think we are watching that carefully and continue to sharpen our plans, including making sure that supply is ready at time of launch.
spk09: Thank you. Okay. On Omidria, you know, you've talked obviously about the guidelines that CMS has brought up and the No Pain Act, but can you really itemize what does that mean for patients What does that mean for the use of Imidria, and specifically around how the clinicians would use this, how patients would receive this? And I'll hop back in the queue afterwards. Thank you.
spk10: Sure. Well, first, there is the currently extant non-opioid alternative exclusion. under which OMIDRIA is being separately paid in the ASCs. And that has been in place, CMS put that in place in 2019, and it has remained in place really without change since that time. So we expect that that is a policy, particularly given the current opioid crisis frankly, the opioid epidemic. The expectation is that that policy would continue well into the future. What the No Pain Act would do is secure that separate payment for non-opioid alternatives used during surgery, so during surgical procedures of which Omidrea would be included. for a period of five years, renewable by Congress, and it would expand the separate payment from the ASCs to include procedures performed in HOPDs. Now, for cataract surgery, that's important. I think, as I mentioned during the prepared comments, about 20% of cataract procedures, somewhere around there, maybe a little less, the shift continues to move toward ASCs, but let's say that's 20% of the total procedures are performed in HOPDs. And what we're most interested in, and again, what we very much appreciate CMS recognizing and moving to ensure, is that patients and physicians should have access to Omidria. and drugs like Omidrea. Whether they choose to use it or not should be a decision made by the physician in consultation with his or her patient. But the access should be absolutely preserved. That's what the current policy of CMS does in the ASCs. We think that's important to expand to the HOPDs as well so that patients who have cataract procedures performed in the HOPDs have the same access to the quality of care that patients have in ASCs. And we were really quite heartened by CMS's request for comments on the potential of expanding the non-opioid exclusion from the ASCs to include HOPDs as well.
spk09: Got it. Thank you for that explanation. Let me hop back in. Thank you.
spk10: All right. Take care, Steve.
spk08: The next question comes from Hannah Adeyoye with J.P. Morgan. Please go ahead.
spk12: Hi. Good afternoon. This is Hannah on for Eric Joseph. Thanks for taking the questions. So first, with regard to the Artemis IGAN study, can you just speak to the role of SGLT2 inhibitors in the trials? Some physicians that we've talked to have noted that these are currently considered standard of care in the indication. Do you have or do you allow for the enrollment of patients currently on SGLT2 inhibitors in the study? And then secondly, given reductions in proteinuria may not necessarily translate to long-term kidney function improvement, can you just reiterate what gives you confidence in proteinuria as an endpoint for registration? And then also, is that the only endpoint of focus or would you have to show some level of preserved kidney function? And I have a follow-up after that. Thank you.
spk10: Sure. With respect to SGL2s, those are not. Those are excluded from the clinical trial. With respect to your question about kidney function, we are also looking at EGFR as really are all products in development for IgA nephropathy. The question is, how will that EGFR be used? In the setting of a regular approval on proteinuria, which based on our discussions with FDA, narsoplumab can achieve. I believe it's the only one that can achieve regular approval on proteinuria alone. If that were to, and that is based on the rapidity and magnitude and the reduction of proteinuria seen in our earlier studies. But let's say that regular approval is obtained, then EGFR data really becomes a safety endpoint, meaning is EGFR remaining stable, ensuring that EGFR does not meaningfully fall off. In the event of an accelerated approval, which is similar to what colitis' drug received. EGFR then becomes the confirmatory endpoint in the, or the primary endpoint in the confirmatory trial. And that is, again, a possibility for us as well, depending on the magnitude of proteinuria reduction. With respect to is EGFR a meaningful endpoint and does it correlate with proteinuria? Yes. The answer to both of those is yes. The data clearly show Dr. Leslie Inker's data, which have been published I think now two publications or more on that, that there is very good correlation between EGFR improvement and proteinuria reduction. Steve, again, I'll look to see if you've got anything you want to add to that.
spk06: I don't have anything. Thanks, Greg.
spk10: All right.
spk12: Okay. Great. Thank you. That's very helpful.
spk08: The next question comes from Ram Silvaraju with HC Wainwright. Please go ahead.
spk07: Hi, this is Mitchell on for Ram. Thank you for taking our questions. The first question I just wanted to ask, I know you can't comment much on the formal dispute resolution, but if there was an adverse decision, would you be able to appeal if that were the case?
spk10: Hi, Mitchell. Yes. I mean, again, you're right. We don't want to comment on ongoing discussions. But if we had a negative opinion, which I hope and I frankly hope Optimistic will not be the case, but let's say that did occur. Yes, we do have the ability to appeal higher within the agency.
spk07: Okay, great. And then thinking about the principal sales-related activities that Raynor is engaging in, could you talk about those and how they could spur the uptake of Omidria and how high do we think that sales could potentially go in the near term? Sure.
spk10: Well, the sales force that Rainer has is the sales force that was within Omeros selling Omidra. So this is what we believe, and I think Rainer shares this belief, is really one of, if not the premier, ambulatory surgery center detail forces in ophthalmology. So this is a group that's really outstanding at selling Omidria, and frankly it's a drug that has great benefits and has not been shown to have any safety issues, so that's also helpful in the sales process. But I think that clearly separate payment and the continued relative certainty of separate payments plays an important role there, right? Because what physicians and what ASC administrators do not want to do is have to change protocols or procedures frequently. And in the time period where we had OMIDRIA reimbursement, then OMIDRIA reimbursement was taken away for some discrete period of time, that creates discomfort and it creates disruption within the ASCs and the management of those procedures. So I think certainly having continued separate payment or relative certainty of separate payment is very helpful. I think also Raynor is highly focused on the sales of Omidria and I expect and I know that they are thinking I can't speak for them, but I understand that they're considering further expanding the sales force to further drive sales. And then again, it's their ability to generate sales ex-US that is also appealing to us. And there we receive 15% royalty on net sales. So I think I think Rainer's doing a really wonderful job of pushing forward the product. I think the other part of your question was where do we think sales can go? I'd like to withhold a comment there, but I certainly, other than to say I think it's a multiple of what they currently are.
spk07: Great. Thank you so much for the detail. Appreciate it. You're welcome.
spk08: The next question comes from Brandon Foulkes with Cancer Fitzgerald. Please go ahead.
spk00: Hi, thanks for taking my question. Maybe just on OMS 906. Should we think of you focusing on either the treatment naive patients or the patients with the unsatisfactory response to the C5 inhibitors going forward, depending on data? Or should we think of you bringing both of those indications forward? And then similarly, can you just help us think through the impact of the different routes of administration and how they may impact the ultimate addressable market just between that once quarterly IV, the once monthly, and maybe the sub-Q? Thank you. Thanks, Greg.
spk10: Sure. Hi, Brandon. I'll answer part of that, and then I'm going to hand it off to Steve for additional comment. But first of all, with respect to the target indication, the reason that we begin or began with patients on ravulizumab is it allows access to PNH patients, right? Most patients are currently receiving some sort of treatment in the PNH community. So this allows us to access patients. We have now been able to find patients who are PNH patients and treatment naive. The advantage of that is the efficacy signal can be obtained much more quickly than waiting to take a raviolizumab patient and take them off raviolizumab as we transition to narsoplimab. So that's the advantage. Where we see the market, I think, is largely agnostic. We believe that there are meaningful advantages, as I think I detailed in the prepared comments. We think those are important. One, infection. Two, dosing convenience or infrequency of dosing. And then the third is the difference between an acute phase reactant as a target and a target like MASP3 that is not an acute phase reactant. All of those are meaningful, and I would underscore the acute phase reactant difference, which we think is a very meaningful difference. Steve, let me turn it to you and see your thoughts on this. Thanks, Greg.
spk06: a little bit from you on one point. The treatment naives are clearly very, you can show it very rapidly, but in the study that we're going to look at Ravalizumab, we can see efficacy in that relatively quickly when we start the combination therapy as well. And so we certainly aren't dependent on one population or the other to see the efficacy. As Greg said, we believe this will be very strongly competitive in the market. Once we see efficacy in P and H, that will give us even higher confidence than we have now that this will be applicable across a wide variety of alternative pathway diseases. Our thinking isn't limited to P and H or to C3 glomerulopathy. Seeing rapid efficacy in these indications will certainly open up or give us even higher confidence that this will be effective in a wide variety of diseases. And finally, as far as the sub-Q versus IV goes, at least I've talked to several physicians about this. You can hear different opinions on what they think patients want, but I can tell you that there's great enthusiasm for both routes of administration. Both would be well-accepted. With the dosing frequency that we're proposing.
spk10: Exactly. Right. And, you know, part of this, Brendan, is when you look at MASP2, there's no predicate because of our IP position around the lectin pathway and MASP2 specifically. So most don't really understand what is the potential for a MASP2 inhibitor. until we get narsoplumab across the finish line, which we hope to do quickly, that will answer that question. But in the alternative pathway space, there are alternative pathway inhibitors on the market. And so it's pretty well understood what the market opportunity is for those, what you need to show to be effective. And I think that that sets up very nicely for OMS 906. When we demonstrate efficacy, as Steve says, in one indication or two indications, then I think it becomes pretty clear that the applicability of OMS 906 is really across all of those alternative pathway indications that have been identified and for which other drugs are currently approved. And then the question becomes, okay, so what are the differentiators between OMS-906 and those other drugs? And I think those are what we highlighted in the prepared comments. Those are what I think we've talked about, again, just in this exchange. And I think you really need to look at those because I think those become become quite important so the question is is 906 effective as an alternative pathway inhibitor yes or no we believe that all of the data we have to date certainly certainly weigh on yes it is but let's see we'll have data I think soon enough that will answer the question and then that question or once answered, becomes broadly applicable.
spk03: Was there a follow-up, Mr. Polks? All right.
spk08: This concludes our question and answer session. I would like to turn the conference back over to Dr. Gregory Dimopoulos for any closing remarks.
spk10: Thank you, operator, and once again, thank you, everyone, for joining us today. We'll continue to keep you updated on our progress. As always, we appreciate your continued support, and have a good evening.
spk08: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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