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spk01: are advancing. In addition to our work with narsoplumab in COVID-19 and completing the rolling BLA submission in TATMA, our other Phase III programs for narsoplumab continued to progress in the third quarter. Our Phase III trials in atypical hemolytic uremic syndrome, or AHUS, and in immunoglobulin A, or IgA nephropathy, are ongoing. Our focus remains on IgA nephropathy and on our Phase III Artemis IGAN trial, which has now nearly 120 sites activated worldwide. Interestingly, data from multiple research groups now indicate that the tubulointerstitial disease component in IgA nephropathy involves lectin pathway activation on the surface of damaged tubular cells. caused by proteinuria and or ischemia reperfusion injury associated with, for example, acute kidney injury, leading to tubulointerstitial inflammation and fibrosis. This evidence further underscores the role of the lectin pathway in IgA. Narsoplumab appears to be the only drug with FDA's breakthrough therapy designation for IgA nephropathy and the only drug that can obtain full approval on proteinuria data alone, potentially shortening the full approval process by years by not needing to show improvement in EGFR. We think that there are good reasons for these singular distinctions afforded in our supplement, and we look forward to seeing and sharing the data. We view narsoplumab as not just a drug, but as a platform therapeutic. and we continue to expand the scope of indications that we're targeting for narsoplumab and our other MASK2 inhibitor programs beyond endothelial injury syndromes and proteinuric renal diseases. MASK2 and the lectin pathway play a central role in the innate inflammatory response, and their importance in driving a long list of diseases and disorders is becoming increasingly recognized and understood. Our long-acting MASK2 antibody, OMS1029, is expected to be in the clinic in early 2022 and to allow once monthly or even less frequent subcutaneous dosing. We're hoping to follow that up quickly with our orally available MASK2 inhibitor. Before moving on to Omidri and other programs in our pipeline, I'll bring you up to date on our other complement program, OMS906, our MASP3 inhibitor. MASP3 is responsible for the conversion of Profactor D to Factor D and is thought to be the key activator and premier drug target in the alternative pathway. In September, we began dosing human subjects in a placebo-controlled, double-blind, single ascending dose and multiple ascending dose phase one clinical trial. The trial is running on schedule. Our first cohort has already completed dosing. The second cohort is being dosed now. And the third and fourth cohorts are enrolling. Initial data readout is expected in the coming year. Data from our OMS 906 program were presented last month at the fourth complement-based drug development summit. And the presentation can be found on our investor relations website. As with our MASP2 program, we're also moving ahead with the development of orally available small molecules that inhibit MASP3. OMS906 is a long-acting antibody achieved in part by modifications to its FC region. To avoid primarily any potential encumbrance to the late stage clinical or commercial manufacturing of OMS906, At its current manufacturing facility, we recently entered into a licensing agreement with Zencore, as have a good number of other companies with antibody therapeutics that have long half-lives. We expect that this will entail the payment of modest milestone fees and low to mid-single-digit royalties, while Zencore's patents remain extant in the jurisdiction of sales. In parallel with our MASP2 and MASP3 clinical work, a great deal of complement research is being done both in our Seattle facilities and in our labs at the University of Cambridge. Our work has previously resulted in redefining the biology of the complement system. Examples include the C4 bypass mechanism by which MASP2 directly activates C3 and the role of MASP3 in activation of the alternative pathway. Our team continues to redefine complement biology, and we plan to publish these new discoveries once we have securely established the corresponding patent positions. So let's turn now to Omidria, our commercial ophthalmic drug product. Net revenues from Omidria in the third quarter were $26.1 million after deducting out $8.7 million return reserve associated with the October 1st expiration of pass-through for Omidria. Had we not booked this return reserve, our Q3 revenues would have been an all-time record high. This was despite the headwinds of COVID-19, which, because of the additional safety precautions required in the operating room, continued to affect overall cataract surgery volumes by restricting throughput of cases in the surgical facilities. Our net loss for the quarter was $38.5 million, or 66 cents per share, of which $13.6 million, or 23 cents per share, were non-cash charges. Our non-GAAP adjusted net loss for the quarter was $19.9 million, or 34 cents per share. This non-GAAP adjusted net loss also conservatively includes the $8.7 million or 15 cent per share deduction from our third quarter revenues for the return reserve. If and when reinstatement of separate payment for OMIDRI occurs, we expect to recover the $8.7 million reserve. As of September 30, 2020, we had $153.5 million of cash and investments available for general operations. This includes the receipt of net proceeds from our third quarter financing activities, specifically $93.7 million from the issuance of 6.9 million shares of stock, and an additional $76.9 million from issuing new unsecured convertible debt after repurchasing $150 million of unsecured debt that was previously outstanding. We also purchased a capped call on the new debt that effectively increases the initial conversion price of $18.49 per share to $26.10 per share. This substantially reduces dilution or cash expense in the event of a conversion. We saw some encouraging trends in Omidria sales in the third quarter as well. Despite reportedly longer surgical turnover times and reduced cataract surgery procedural throughput due to COVID protocols in surgical facilities, per-facility utilization of Omidria and Q3 increased over pre-COVID levels. Also, overall units sold progressively increased throughout the quarter. We expect that this momentum will be restored and continue to grow if and when Omidria is granted separate payments. As previously discussed, our extension of pass-through reimbursement for OMIDRIA expired on October 1st. The result of that is that OMIDRIA, when used for Medicare Part B beneficiaries, is now reimbursed as part of the ambulatory payment classification for cataract surgery. We have had multiple meetings with CMS and HHS and have made a compelling case based on regulatory law. that CMS must pay separately for Omidrea as a non-opioid alternative used during surgery in the ASC setting now that the drug's pass-through status has ended and it is packaged under CMS's outpatient prospective payment system. The criteria for separate payment are strictly objective and Omidrea meets them all. We are optimistic that CMS will comply with its own regulation and provide separate payment for Omidria in the ASC during the fourth quarter of 2020 and throughout calendar year 2021, which subsequently could be further extended. In parallel, a broad coalition led by Voices for Non-Opioid Choices and supported by over 50 bipartisan House representatives and over 20 bipartisan senators continues to advocate for the No Pain Act. This bill would extend separate payment in the ASCs and in the hospital outpatient surgery departments for a period of at least five years for Omidria and other non-opioid alternatives used during surgery. In addition to strong support from surgical and nursing societies, trade organizations as well as patient advocacy groups and individual practitioners, two large and influential societies The American Medical Association and the American Society of Anesthesiologists have recently endorsed the No Pain Act. An opportunity for enactment of this bill could come during the lame duck session of Congress. You might recall that a peer-reviewed publication in the Journal of Cataract and Refractive Surgery showed that Omidria significantly reduced the need for intraoperative fentanyl, a highly addictive opioid, while also reducing patients' pain. Another manuscript demonstrating that Omidrea is opioid-sparing was recently published in the peer-reviewed journal Current Medical Research and Opinion. The study demonstrates that patients who received Omidrea during cataract surgery were prescribed fewer post-operative opioid pills than patients who did not receive Omidrea, despite the Omidria treated group having a greater incidence of preoperative comorbidities and higher risk for surgical complexity. To continue to build validation of the opioids bearing benefits of Omidria within the published literature, we have partnered with the Cataract Surgery Pain Study Group. The Cataract Surgery Pain Study Group is led by Dr. Terry Kim, President of the American Society of Cataract and Refractive Surgery, and Professor of Ophthalmology and Head of the Cornea and Refractive Surgery Services at Duke University, together with other cataract surgery thought leaders from across the nation. The group's mission is to examine the role of non-opioid alternatives like Omidria in cataract surgery. Based on the group's research, multiple publications will likely be generated adding to the body of literature supporting the role of Omidria in reducing the need for intraoperative and postoperative opioids in cataract surgery. The pain study group's research and publications should further strengthen the case for the separate payment of Omidria by CMS. In the meantime, our commercial team is focusing its Omidria efforts on driving utilization in hospitals across commercially insured patients, and in VA facilities. The advocacy and relationships we have in the ophthalmology community remain strong. We have multiple avenues to secure separate payment for Omidria, and we will let them play out. While we are planning for success, we also have established alternative sales strategies. If needed, these can be implemented quickly to ensure that Omidria will be available for the long term and providing value to both patients and our shareholders. Moving on to our phosphodiesterase 7 or PDE7 inhibitor program, OMS527 targets addiction. Our phase 1 clinical trial was successful, both with respect to safety and achieving daily oral dosing. While our current clinical focus remains on expanding indications for our MASP2 and MASP3 complement franchises, We plan to advance our OMS527 Phase II program pending resource availability. We also continue to see a unique opportunity in targeting GPR174 for cancer immunotherapy. GPR174 is an immunosuppressive G protein coupled receptor whose activity is intimately linked to the tumor microenvironment. Our recent data with mouse tumor models further validate GPR174 as an important and novel target for enhancing a T cell's capacity for killing cancer cells. We have found that GPR174 deficiency in tumor-specific CD8-positive cytotoxic T cells increases their activation, resulting in anti-tumor immune responses that markedly reduce tumor growth. Similar to GPR174, the adenosine GPCRs A2A and A2B are also activated by products of the tumor microenvironment with all three receptors, GPR174, A2A, and A2B, using the same cyclic AMP signaling pathway. Our ongoing in vitro signaling experiments continue to reveal that inhibition of all three receptors synergistically enhances T cell activity. So we believe that new and more effective cancer immunotherapy approaches will involve GPR174 inhibitors alone or in combination with adenosine receptor inhibitors. Motivated by this understanding, we are aggressively developing both small molecule and antibody inhibitors of GPR174. Our team continues to make discoveries around the GPR 174 program, and we plan to make those public after filing additional patent protection. With that, I'll turn the call over to Mike for an overview of our third quarter financial results. Mike?
spk09: Thanks, Greg. As Greg noted, the mid-range and total revenues for the third quarter were $26.1 million. Our net loss for the quarter was $38.5 million or 66 cents per share, which does include a technology access fee of $5 million or 9 cents per share and non-cash expenses of $13.6 million or 23 cents per share. And of the non-cash expenses, $6.4 million or 11 cents per share were directly associated with the closing of our recent debt financing. Adjusting for these items, our adjusted net loss on a non-GAAP basis was $19.9 million, or 34 cents per share. Both the GAAP net loss and adjusted net loss also include a deduction of $8.7 million, or 15 cents per share, from total revenues in the third quarter for a Omidria return reserve related to the October 1st expiration of pass-through. Upon reinstatement of separate payment for Omidria, we expect to recover the $8.7 million reserve. As of September 30th, 2020, we had $153.5 million of cash, cash equivalents and short-term investments available for general operations. The increase from the second quarter is due to two factors, the first being $93.7 million in net proceeds received from the sale of the 6.9 million shares of our common stock in an underwritten public offering. In addition, during the third quarter, we issued $225 million of five and a quarter percent unsecured senior convertible debt, and we purchased $115 million of our outstanding 6.25% unsecured senior convertible debt. The new notes are callable after three years and are due in February of 2026. In conjunction with the issuance of the new convertible notes, we did purchase a cap call that offsets the dilutive impact or potential cash expenditure associated with the conversion of the new notes, while the market price of our stock trades between the initial conversion price of $18.49 per share and the cap price of $26.10 per share. As I previously stated, our mid-year revenue for the third quarter includes a deduction of $8.7 million or $0.15 per share as a return reserve. As you may recall from some previous calls, upon the expiration of pass-through reimbursement, we recorded a return reserve for any product that at our wholesalers that might not be sold to ASCs and hospitals should separate payment not be reinstated and for any unused inventory at the ASCs or hospitals that may be returned to us. In the event that separate payment is reinstated in the near term, the inventory should be used and we would reverse the return reserve accrual, resulting in incremental OMEDIA revenue. Research and development expenses were $31.3 million for the third quarter, an increase of $7.2 million over the second quarter. The increase was primarily related to the $5 million technology license agreement for OMS 906, our MAS III product candidate, removing any potential encumbrance to the late-stage clinical or commercial manufacturing of OMS 906 at its current facilities. With respect to our manufacturing activities for narsopalmab, six additional batches of drug substance are underway at Lonza, and next month we will be making additional drug product at Vetter. All of the drug substance and drug product being made at Lonza and Vetter are expected to be available for commercial sale following the anticipated approval of narsopalmab in TA, TMA for use in treating critically or for use in treating critically ill COVID-19 patients. As you may recall, manufacturing costs are generally expensed to R&D if incurred prior to the first approval in the U.S. or Europe. After approval, these manufacturing costs will be capitalized as inventory on the balance sheet. Selling general and administrative expenses were $19.8 million, an increase of $2.9 million from the prior quarter. The increase was primarily due to sales and marketing activities in connection with the U.S. launch of Narsopimab. Interest expense for the current quarter was $6.9 million. The $900,000 increase in the second quarter primarily reflects the $110 million in net new borrowings. In connection with the repurchase of a portion of our previously outstanding convertible debt, we incurred a non-cash loss of $13.4 million related primarily to the unamortized discounts that remained on the retired debt. The debt transaction also triggered the recognition of a $7.9 million tax benefit for the third quarter. Now let's take a look ahead to the fourth quarter. As we've discussed, pass-through reimbursement expired on October 1st. We believe we have multiple avenues to obtain separate payment from CMS for Medicare Part B patients receiving Omidria, but we cannot guarantee if and when we will be successful. Therefore, we cannot predict future Omidria product sales at this time. Our R&D expenses for the fourth quarter should be slightly higher than the third quarter of 2020. This is due to the additional commercial drug substance lots being made at Lonza which should be ready for delivery in the fourth quarter of this year and in the first quarter of next year. We are also making additional commercial drug product at Vetter during the fourth quarter. As mentioned earlier, these costs are generally expensed to R&D until norsopimab is approved by the FDA. SG&A costs are expected to increase slightly in Q4 as we continue to prepare for the U.S. launch of norsopimab for TA, TMA. Interest costs for the first quarter should be approximately $8 million, approximately half of which is non-cash. With that, I'll turn the call back over to Greg. Greg?
spk01: Thanks, Mike. And with that, we'll open the call to questions, operator.
spk07: Thank you, sir. Ladies and gentlemen, if you have a question at this time, please press the star, then the number one key on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Your first question is from Jeff Mecham from Bank of America. Your line is open.
spk04: Good afternoon. Thank you so much for taking the call and congratulations on the quarter. This is Jason calling in for Jeff. Just a couple of quick questions, if you will. When we think about the TMA submission process, for narslopramab. In terms of how it could be potentially differentiated versus other complement inhibitors being studied, if you could talk a little bit to that point, especially with Altamaris moving ahead in that indication. And then when thinking about the COVID-19 program, any status regarding kind of, you know, or at least your projection for government funding, You know, if we think about the treatment of severe patients now with the new administration and potentially the vaccine kind of taking care of a lot of the maybe less severe patients, you know, where do you see that going and how might it evolve? Thank you.
spk01: Sure. Thanks, Jason. In response to your first question about how MASK2 inhibition or specifically narsoplumab is differentiated from other complement inhibitors in TA-TMA. It's really along a few fronts. First is the role of the lectin pathway, and specifically MASP2, in endothelial injury, right? We know that TA-TMA is caused by endothelial injury, and that endothelial injury specifically activates the lectin pathway, MASP2 being the effector enzyme of the lectin pathway. We also know that MASP2, at least to the best of our knowledge, is the only complement factor or complement enzyme that has coagulation activity outside of the lectin pathway. MASP2 directly acts on the coagulation system, and that function is independent of its role in the complement system. And narsoplimab, by inhibiting MASP2, specifically blocks that MASP2-mediated coagulation activity, which is specifically the conversion of prothrombin to thrombin and the conversion of factor 12A, factor 12 to 12A, so the activation of factor 12. Those activities are blocked by narsopalimab. We don't know of another complement enzyme that is involved in that, and by extension, we don't know of another complement inhibitor that has those same effects on the coagulation cascade. And when you look at stem cell TMA, just as in COVID, obviously there is a significant component which is driven by the coagulation cascade or the hypercoagulability, which is why you see thrombi in the thrombotic microangiopathy, which is TATMA. An additional difference, and I think we've hit on this several times before, is that, you know, these are patients who are very sick, and MASP2 by inhibiting or narsoplumab by inhibiting MASP2 leaves intact the effector function of the adaptive immune response. And that's very different than, for example, a C5 or C3 inhibitor, which blocks the the effector function of the adaptive immune response, which is important, kind of critically important in fighting infection. And that's why some have reported that in adults with use of C5 inhibitors in TATMA, that the survival rates are actually decreased, very different than what we're seeing in stem cell TMA with narsoplumab treatment. So let me stop there and see if that answers your first question about the differentiation.
spk04: It does. It sounds like you think that there's going to be enough differentiation that you could at least see the difference at some level in terms of kind of the tissue damage and kind of hemorrhagic output versus another more traditional complement inhibitor?
spk01: I think the simple answer to that is yes. Yes, we do. And traditional complement inhibitor, I guess you're referring to a C5 inhibitor in that sense. Traditional because there are a number of groups targeting C5. Remember that we are the only group that really can target C5. MASP2 because of the intellectual property position we hold around it. So while we may seem unique in targeting MASP2, I don't think that's driven by the biology around the target or the biology around the lectin pathway. I think it's frankly mandated by the intellectual property position we control around MASP2 and the inhibition of the lectin pathway and lectin pathway associated disorders. So let me jump to your second question, which is around our work in Bergamo on COVID-19 patients. We are continuing to treat under compassionate use patients both in the U.S. and in Bergamo with Narsoplimab. And what we are seeing is similar striking results. results to those which we saw in the first six patients in Bergamo. Our discussions with the government agencies are progressing, and I think progressing well. You had a specific question with respect to funding. We're not going to predict at this point if or when we would receive funding, simply to point out that Clearly, that is our objective in those discussions. With respect to timing, again, I think best not to speak to that now, but to say, look, it's pretty clear that there is no other drug that we know of that has shown the results in really critically ill COVID-19 patients that narsoplumab has shown. We think that narsoplumab has a role to play in fighting this disease. I mean, I think today the news that Johnson & Johnson put out, tremendous news. I mean, very exciting. I mean, imagine if we can, I'm sorry, that Pfizer put out that, you know, tremendous news. I mean, we may all be able to get back to work at some point and our children can go back to school. That would be great. I think despite that, there's always going to be a need for the treatment of critically ill COVID patients, assuming those vaccine data continue to show the same efficacy long term. But I think that clearly, I think there's a focus on narsoplumab as the surge in COVID-19 cases increases. And I think we're well positioned for that.
spk04: Perfect. Thank you so much for the color. Really appreciate it.
spk01: Thanks, Jason.
spk07: Your next question is from Steve Brozak from WBD. Your line is open.
spk00: Yeah. Hi, Gregan. Thanks for taking the questions. I've got two, and I'll jump back in the queue. The first one is on Omidria. Can you tell us or differentiate why, in this particular case, it's different with CMS today as it was vis-a-vis, let's say, one year ago when you were looking for ruling from them? And then I'll ask one more question, please.
spk01: James Jensen- Sure. There is a significant difference between this year and last. Last year, as you know, OMIDRIA was separately paid. And so, we did not qualify under the criteria laid out by CMS for separate payment other than under pass-through, which is what we had. The criteria that CMS has laid out are not discretionary, and they do not depend, for example, on some subjective determination of the efficacy of the drug, but rather it's really the objective characteristics of the drug. To be clear about that, let me just specify. To qualify, a drug must be a non-opioid drug. It has to be used in pain management. It has to be employed in the ASC setting. It has to be policy packaged. And it has to function as a supply in a surgical procedure. You know, really, each of these is binary. Each of these is objective. And each applies to Omidrea now. because it is no longer under pass-through. That pass-through status has expired, which means that we are now functioning as a supply in a surgical procedure and we are policy packaged. So it's not that CMS in any way needs to reverse itself from a year ago. That's not the situation at all. It is just simply that the the situation has changed. And now that it has changed, OMIDRIA clearly qualifies. And that's why we believe the case is quite compelling and we believe certainly we're confident that CMS will comply with its own regulation and provide us with that separate payment.
spk00: Okay, thank you. That is obviously something we're all going to be waiting for. The second question, and I'll hop back into the queue, can you give us any kind of details as far as Narsupplamab goes with Bergamo, any additional information coming back, anything that you can tell us? And, again, thank you. I'll hop back into the queue.
spk01: Well, as I said earlier, look, the results that we're seeing in Bergamo and the additional patients that we're treating under compassionate use are really very similar to what we saw in the initial six patients on whom we've already reported. We've publicly spoken about one patient. One of those new patients, I believe, was a 76-year-old fellow, a diabetic, obese, long history of smoking, long history of COPD, status post surgical treatment for prostate cancer, and this patient was rapidly deteriorating. He came in, was admitted, put on nasal cannula, quickly moved to mass, quickly moved to CPAP, and from there to intubation. And we were given that patient after he had already been intubated and was deteriorating. Very quickly, the patient began to recover. We've made public, in fact, I believe on our website, are the laboratory values, the longitudinal laboratory values on this patient, which show that those laboratory values progressively improved and quickly improved, as did the patient's clinical status. I believe now the patient has been discharged. So, you know, these are patients who certainly you wouldn't expect very many of them to survive. And yet, you know, we're showing very strong survival with the use of no supplement.
spk00: Again, thank you for taking the questions, and I'll hop back into the queue. Thanks again.
spk07: Your next question is from Ram Selvaraju from HC Wainwright. Your line is open.
spk06: Good afternoon, gentlemen. Thank you for taking the question. Are you seeing any new restrictions on Omidria because of COVID-19's resurgence?
spk01: I'm sorry. I think I heard the question. Are we seeing any new restrictions on Omidria because of COVID-19?
spk06: Yes, that's the question.
spk01: Yes. You mean restrictions specific to amidria or just changes in practice because of COVID-19?
spk07: More a practice level.
spk01: Yeah, I'll actually answer both. First, with respect to the general practice around cataract surgery, what we are seeing is longer turnover times between cases, and that's to increase the the focus on cleaning and making sure that all protocols for cleaning the ORs are followed. So the result of that is, I believe, and I think our commercial team has seen, a reduction in the throughput of cataract surgery cases effectively at any given facility. If your turnover time between cases is lengthened, the number of cases you can do in any given amount of time will be less. So certainly we've seen that. I think surgeons are trying to get as many cases as they can done. So those surgeons are working longer hours. They may be increasing their OR days to be able to accommodate the number of patients that need cataract surgery. With respect specifically To Omidria, no, we haven't seen any additional restrictions placed on Omidria. In fact, I would think we're seeing quite the opposite. I mean, I think the heightened sense of safety in this period of COVID and all of the things that I just talked about being tied to safety, I think have really put a focus or a spotlight on Omidria because of its safety. I mean relative to really what is a potential alternative and really quite an inferior alternative of compounded products. I think that this sense of and need for safety has really increased probably the utilization and I think that's consistent with what I mentioned in the prepared which was that we are seeing a per-facility increase in the utilization of Omidria, and that's compared to pre-COVID levels. So I don't want to be adding two and two and getting 22, but certainly I think those two findings seem to support each other.
spk06: Very encouraging. How many doses of norsoprimab do you expect to have manufactured by mid-2021?
spk01: We have, I don't know if we've given the specific number, although what we have done is we've run now two separate sets of manufacturing runs. So I think we've previously reported that in January of this year that we had manufactured a number of lots of narsoplumab and that those were successful, both with respect to drug substance and drug product, and that those alone were sufficient to support the launch of narsoplumab for TATMA. What we've also mentioned, and I think Mike spoke to it in his comments, we again are manufacturers. and are in the process of manufacturing another set of runs of narsoplumab. And I think Mike may have even given the specific number, which is another six runs. So clearly we're looking at it as we have substantial and certainly what we expect would be more than enough for our launch. And I think what we're really looking at as well is in the setting of critically ill COVID-19 patients having drug available to at least initially start treating those patients.
spk06: Thank you. And just lastly, very quickly, what clinical development path do you expect to pursue in regards to methopalimab in COVID-19? And what, if anything, do you expect to benchmark it against?
spk01: That's a good question. We are, as I said, Previously, we're in discussions with government agencies. We also have been approached around whether we would be willing, the request has come, for us to include narsopalimab in platform trials. So we're considering specifically that option. It is one that we really can't discuss in detail given the confidentiality requirements around those clinical trials or the confidentiality requirements by those running those clinical trials. But certainly we're considering that. You know, look, from our perspective, we believe we have a drug that works well. I think that the data kind of clearly show that. Works well in critically ill COVID-19 patients. We're confident in that. We think that there is a significant need for a therapeutic in that setting. When we look at the overall benefit-risk balance of narsoplumab, it is heavily weighted toward the benefit. And this is not just in COVID-19 But if you look across all of the indications in which narsoplumab has been used, so TMA or TATMA, AHUS, IgA nephropathy, and in COVID itself, what we have seen, or maybe better stated, what we haven't seen is a safety signal of concern. So when you weigh the benefits of the drug versus any potential risk, and you're looking at patients who have no treatment and who are dying with severe COVID-19 ARDS or ARDS, acute respiratory distress syndrome, it becomes, I think, difficult to deny these patients a drug that appears to be working. We're increasing the number of patients that we're treating. But again, I think it's important to look at it from the other end of the telescope. This is an endothelial injury, meaning COVID-19, as is TATMA. The pathophysiology appears to be very similar between those two disorders. So when you look at it, it's not that we have only treated small numbers of patients with COVID-19. We've treated pretty good numbers of patients with endothelial injury syndrome of which TATMA and COVID-19 are counted among that group. And so, you know, our objective would be to make it available as quickly as possible and those are the objectives. of our discussions.
spk06: Wonderful. Thank you so much for your time.
spk01: Thank you.
spk07: Your next question is from Brandon Foulkes from Cantor Fitzgerald. Your line is open.
spk05: Hi, thanks for taking my questions and congratulations on the call, sir. Maybe first on immediate reimbursement. If you do regain reimbursement through the 2021 ops, does that preclude or delay reimbursement potentially through the No Paying Act Secondly, how do you think about your commercial footprints for TMA? You did call out that you have a higher number of commercial people, but compared to where you want to get to. And then lastly, apologies if I missed this, but did you give more granular timing on the Phase III data for the IGAN trial and the AHAS trial? Thank you.
spk01: Okay. First, with respect to your question on Omidria, The administrative avenue that we're taking with CMS and HHS is entirely independent of the No Pain Act. So assuming that CMS grants us separate payment in the ambulatory surgery setting, which is what we're requesting, and what we are confident is in accordance with regulation and regulatory law, then certainly that is not independent of what could happen or would happen with enactment of the No-Pay Act. The No-Pay Act, as you know, it would provide separate payment not only in the ASC setting, but in the ASC and in the HOPD settings. And the duration of that is currently written at five years. renewable on a five-year basis thereafter. So really no overlap or no restriction that one approach places on the other. They're truly independent. Your other question about, I believe it was timing on IGA first, and then I'll hand you over to Dan Kirby, our head of commercial, to address the specific commercial question you had. But, you know, we are continuing to push with the IGA trial. Enrollment was initially slowed due to COVID-19 as with many drugs, but our objective there is to get that completed and at least have data out of the proteinuria group Again, the target remains next year. Dan?
spk03: Sure. So the commercial footprint, your question was regarding the commercial footprint built out of IgA nephropathy, or was it about our commercial activities regarding HSCT TMA? I just wanted to clarify that to make sure I answer correctly. Brandon? Brandon? Okay, well, what I heard over there, you heard during the call about our commercial footprint that we're building out for HSCT TMA. Things are progressing according to the plan. Greg talked about our coding activities. We also are pursuing an NTAP. We have filed for that. We'll have a meeting later on this quarter. But things are progressing exactly as we planned along with the filing to ensure that we'll be ready to not only launch but successfully launch and capitalize the market. From an IG nephropathy standpoint, We currently are, from a marketing perspective, going through market scoping exercises and market research, looking specifically at the narsopimab target profile up against other alternatives. In regard to advocacy initiatives, we are engaging actively with the advocacy groups, both patient and physician, across the nephrology community. And then from a medical affairs standpoint, we are building out our footprint on medical education there. In 2021, we plan on expanding those activities, looking at product positioning as well as looking at building out more of the medical information standpoint as we get closer to reaching a point where we're ready to file for IG nephropathy. Thank you.
spk01: Thanks, Dan. Brandon, I don't know if you're still there or if that answered your question. Are you on or somehow have you dropped? Okay. Well, are there any other questions? Operator?
spk07: I am showing no further questions at this time. I would now like to turn the conference back to you, Dr. Dimopoulos.
spk01: Thank you very much. So thank you again everyone for taking the time to listen in. These are unprecedented times and I'm proud of the work that our team has done. These have been challenging times for everyone and you see the progress that the team has made. With the progress on narsoplumab specifically, we look forward to it becoming our second commercial drug, and we expect the therapeutic indications for narsoplumab to be broad and that from our pipeline, a long line of important drugs will follow narsoplumab into the market. With that, again, we wish you and your families good health And all of us at Omeros appreciate your continued support. Thank you, and have a good afternoon or evening.
spk07: Ladies and gentlemen, this concludes today's conference. Thank you for your participation. Have a wonderful day. You may all disconnect. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.
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