Good afternoon and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in a 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 a replay will be available on the company's website for one week from today.[Operator Instructions] I'll turn the call over to Jennifer Williams, Investor Relations for Omeros.

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 and the company's quarterly report on Form 10-Q, which was filed today with the SEC and the risk factors section of the company's annual report on Form 10-K 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 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 Jacobsen, Nadia Dac, Cathy Melfi, and Steve Whitaker, our respective heads of Finance, Commercial, Regulatory, and Clinical. We'll start with an update on our MASP-2 program and specifically narsoplimab in stem cell transplant-associated thrombotic microangiopathy or TA-TMA. 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 narsoplimab should be approved for use in TA-TMA 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…

Yes, thanks, Greg. As Greg briefly discussed, on December 23, Rayner acquired OMIDRIA and associated business operations. The cell 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 OMIDRIA 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 OMIDRIA transaction includes royalties on worldwide sales. Omeros will continue to receive royalties of 50% on net sales of OMIDRIA in the U.S. until the earlier week of 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 OMIDRIA over the life of the relevant tax. From an overall standpoint, considering the U.S. royalties in 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 that 30%. Turning to our actual results, a net loss for the second quarter was $30.8 million, or $0.49 per share. This compares to a $33 million loss or $0.53 per share for the first quarter of this year. Our non-cash expenses for the quarter was $3.7 million or $0.06 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 $90.7 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…

Thanks Mike. Operator, would you please open the call to question?

[Operator Instructions] The first question comes from Greg Harrison with Bank of America. Please go ahead.

Hey, good afternoon. Thanks for taking the question. So on the narsoplimab, again, programs, will you announce when the trial is fully enrolled? I'd assume that may be close as the nine month date it will be mid next year. And then where would you expect to see narsoplimab used in this indication? There are certain groups that could be more amenable 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 strategy?

Yes, I don't expect that we will be announcing when enrollment is complete. But I think, you’re correct, Greg and that we are close with respect to where we would use it. 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 2 data are in high protein spellers. So those who are spilling more than two grams per day of protein. But, I think, again, we are guardedly optimistic that the applicability of the product will be brought. But again, let's, let's see the data. Steve, any any additional comments?

I guess I'd say that. It's important to remember that despite the fact there could be potentially two other products on the market at that time, that the improvements we showed had been greater than what they reported. And this does look like a first line therapy, at least for a large number of patients.

To Steve's point, as you look, the magnitude of proteinuria reduction with narsoplimab shown today, it has been 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.

Okay, great. Thanks for taking the question.

Thanks, Greg.

The next question comes from Steve Brozak with WBB. Please go ahead.

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 our supplement, for instance, drug availability, and anything else that you can give us any kind of clarity on around our supplement. I've got a question on the mid-way after that. Thank you.

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 let me ask Nadia, if she'd like to add anything to that.

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.

Okay, on OMIDRIA you've talked obviously about the guidelines that CMS has brought up and the NOPAIN Act, but can you can you really itemize what does that mean for patients? What does that mean for the use of OMIDRIA 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.

Sure. Well, first, there is the currently extent, 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 NOPAIN Act would do is to secure that separate payment for non-opioid alternatives used during surgery. So during surgical procedures, of which OMIDRIA 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 OMIDRIA, 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 CMSs request for comments on the potential the expanding the non-opioid exclusion from the ASCs to include HOPDs as well.

Got it. Thank you. Thank you for that explanation. Let me hop back in. Thank you.

All right. Take care of Steve.

The next question comes from Hannah Adeoye with JPMorgan. Please go ahead.

Hi, good afternoon. This is Hannah on for Eric. Joseph. Thanks for taking the questions. So first, with regard to the [Indiscernible] study, can you just speak to the role of SGLT2 inhibitors in the trial? Some positions that we've talked to you have noted that these are currently considered standard-of-care in the indication? Do you have we do allow for the enrollment of patients currently on SGLT2 inhibitors in the study? And then secondly, given reductions in preliminary on may not necessarily translate to long term kidney function improvement. Can you just reiterate what gives you confidence in proteinuria at the endpoint for registration? And then also, is that the only end point of focus or would you have to show some level of preserved kidney function, then I have a follow up onto that? Thank you.

Sure. With respect to SGLT2s, 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 data discussions with FDA narsoplimab 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, does not meaningfully follow up. In the event of an accelerated approval, which is similar to what colitis is colitis as drug receive. EGFR then becomes the confirmatory endpoint in the -- 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 Inkers data, which had 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 got anything to you want to add to that?

Not anything. Thanks, Greg.

All right

Okay. Great. Thank you. That's very helpful.

The next question comes from Ram Selvaraju with H C Wainwright. Please go ahead.

Hi, this is Mitchel [ph] 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?

Hi, Mitchel. Yes, I mean, again, you're right. We don't want to comment on on-going discussions. But if we had a negative opinion, which I hope, and I frankly, I’m 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.

Okay, great. And then thinking about the principal sales related activities that Rayner is engaging in, could you talk about those and how they can spur the uptake of OMIDRIA? And how high do we think that sales can potentially go in the near term?

Sure. Well, the sales force that Rayner has is the sales force that was within Omeros selling OMIDRIA. So this is what we believe. And I think Rayner 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, 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 than OMIDRIA reimbursement was taken away for some discreet 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 that Rayner is highly focused on the sales of OMIDRIA. And I expect and I know that they are thinking, again, I don't, 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-U.S. that is also appealing to us. And there we receive 15% royalty on net sales. So I think I think Rayner is 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 comment there. But I certainly other than to say I think it's a multiple of what they currently are.

Great, thank you so much for the detail. Appreciate it.

You're welcome.

The next question comes from Brandon Folkes with Cantor Fitzgerald. Please go ahead.

Hi, thanks for taking my question. Maybe just on OMS906. 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 dependence 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 one's quarterly IV, the ones monthly, and maybe the subq? Thank you. Thanks, Greg.

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 a 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 ravulizumab patient and take them off ravulizumab, 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 MASP-3 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, very meaningful difference. So Steve, let me let me turn it to you and see your thoughts on this.

Thanks, Greg, I might differ a little bit from you on one point, the treatment naives are clearly very rapid, you can show it very rapidly. But in the study that we're going to look at ravulizumab, what we can see data or 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 is will be very strongly competitive in the market. And when once we see efficacy and PNH that will give us very even higher confidence than we have now that this will be applicable across a wide variety of alternative pathway diseases. So we aren't our thinking isn't limited to PNH 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 subq versus IV goes, we, 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, that there's great enthusiasm for both routes of administration both would be would be well accepted.

With a dosing frequency that…

Right. Yes, exactly.

Right. And part of this, Brandon is when you look at MASP-2 there's no, there's no predicate, because of our IP position around the lectin pathway and MASP-2 specifically. So most don't really understand what is the potential for a MASP-2 inhibitor until we get narsoplimab 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 OMS906. When we demonstrate efficacy, as Steve says in one indication, or two indications, then I think it becomes pretty clear that the applicability of OMS906 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 OMS906 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 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 way 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 wants answered, becomes broadly applicable.

Is there a follow up Mr. Folkes? All right. This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Gregory Demopolis for any closing remarks.

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.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.