Omeros Corporation (NASDAQ:OMER) Q4 2022 Earnings Call Transcript

Omeros Corporation (NASDAQ:OMER) Q4 2022 Earnings Call Transcript March 13, 2023

Operator: Good afternoon. And welcome to today’s earnings call from 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. I will turn the call over to Jennifer Williams, Investor Relations for Omeros. You may begin.

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

Dr. Greg Demopulos: Thank you, Jennifer, and good afternoon, everyone. We will start with the corporate update and an overview of our fourth quarter and full year 2022 financial results followed by a more detailed financial summary. Joining me on the call today are Mike Jacobsen, Nadia Dac, Cathy Melfi, and Steve Whitaker, our respective heads of finance, commercial, regulatory and clinical. Before diving into the details of our specific program updates and coming events, I’d like to spend just a few minutes on our financial strength that we expect will enable those events without the need for near-term shareholder dilution, continuing to position Omeros for success. To provide some background, in December 2021, we completed the strategic sale of the cataract surgery product that we developed and commercialize, OMIDRIA to Rayner Surgical for an upfront payment of $125 million, $31 million of retained receivables, substantial ongoing royalties on Rayner’s net sales of OMIDRIA and the potential to receive a $200 million milestone payment by securing for OMIDRIA continuous separate payment of at least four years.

The initial royalty rate on U.S. net sales of OMIDRIA was 50%, which represented nearly 80% of the total operating profit. Last September, we sold a portion of our future OMIDRIA royalty stream to DRI Healthcare and received $125 million in cash. Because DRI’s annual royalties are capped, and as a result, Omeros received any financial upside in the OMIDRIA royalty stream. The royalty sale was recorded as debt on our balance sheet and no income was recognized related to the sale. Then three months later, in December 2022, Omeros achieved the Rayner milestone, receiving $200 million plus interest in early February. Under our agreement with Rayner after achieving the milestone, the royalty rate that we now receive on Rayner’s U.S. net sales decreased to 30%, which represents approximately 40% of total OMIDRIA operating profits.

Nearly half of all cataract procedures in the U.S. are performed on Medicare Part B patients with surgical and facility fee payments administered by the Centers for Medicare and Medicaid Services or CMS. Since OMIDRIA’s market launch in the second quarter of 2015 through multiple CMS awarded and congressionally mandated pass-through periods, and then qualifying under the non-opioid pain management exclusion from packaging, OMIDRIA has received continuous separate payment from CMS interrupted over those eight years for a total of only 11 months, nine months in 2018, following successful legislation extending pass-through and two months in 2020 after qualifying for CMS’ non-opioid packaging exclusion. But separate payment repeatedly needed to be won.

So we, together with physicians and surgical facilities could never rely on CMS providing separate payment for OMIDRIA long-term. Despite this uncertainty, the drug to-date has infused Omeros with effectively $1 billion in non-dilutive funding, fueling the development of our pipeline, while minimizing both outstanding share count and shareholder dilution. Now let’s look at our financial results for both the fourth quarter and the year. Our net income for the fourth quarter was $128.7 million or $2.05 per share, compared to $280.6 million or $4.49 per share for the fourth quarter of 2021. Both the current and prior year quarters were significantly affected by OMIDRIA’s actions that I just recounted, namely the December 2021 strategic sale of OMIDRIA and the December 2022 achievement of the Rayner milestone.

Looking only at continuing operations, our net loss for the fourth quarter 2022 was $0.73 per share, compared to $0.76 per share for the same quarter in 2021. Our cash burn for the fourth quarter of 2022 was $26 million. Omeros received $17.9 million in royalties from Rayner’s OMIDRIA fourth quarter net sales of $35.8 million, a new quarterly record. Our net income for the full year 2022 was $47.4 million or $0.76 per share, compared to $194.2 million or $3.12 per share in 2021. Our full year loss from continuing operations in 2022 was $182 million or $2.90 per share, compared to a loss of $191.5 million or $3.07 per share in 2021. As of December 31, 2022, we had $195 million of cash and investments and $213 million in receivables, inclusive of the $200 million milestone payment.

All of those receivables have now been collected. So in total, we had $408 million in cash, investments and receivables at December 31, 2022, to support ongoing operations and debt service. A good number of shareholders contacted us last week asking whether our corporate cash and investments were in any way exposed to Silicon Valley Bank. To be clear, we do not have any assets on deposit with Silicon Valley Bank nor do we have any other financial relationship with SVB or its affiliates. The $408 million now in hand provides Omeros the flexibility simply to pay off any or all of the $95 million of convertible debt that matures this November, while continuing to fund operations and advancing our multiple development programs well into 2025. Moreover, the recent signing the Consolidated Appropriations Act of 2023 also known as the 2023 Omnibus Bill mandates that CMS continue to pay separately for non-opioid pain management drugs like OMIDRIA in ambulatory surgery centers or ASCs until at least 2028.

While the majority of cataract surgery has performed in ASCs, approximately 20% of those procedures occur in hospital outpatient departments or HOPDs. Congress address this as well, directing CMS to pay separately for drugs like OMIDRIA not only in ASCs, but also in the HOPD setting, beginning no later than January 2025. The assurance of long-term separate payment in both the ASC and HOPD settings now provides physicians and surgical facility administrators, the confidence that they can incorporate OMIDRIA into their practices and plan on being adequately reimbursed for delivering best care to their patients. We expect this increased certainty in CMS patient — payment to result in meaningful OMIDRIA sales growth. Congressionally mandated long-term separate payment by CMS could also have a direct and positive effect on the other two major coverage systems for cataract surgery, Medicare Advantage and Commercial Insurance plans, driving expansion of separate payment across both of them, which would be good for ophthalmic surgeons and their patients.

The fact that many Med Advantage and Commercial plans are administered by the same payers should accelerate this expansion. There are well over 4 million cataract procedures performed annually in the U.S. alone. As U.S. sales of OMIDRIA continue to grow, Omeros will continue to receive 30% of those revenues as royalties. Potentially further adding to our royalty stream, Rayner is planning to begin selling OMIDRIA outside of the U.S. later this year, resulting in 15% of any of those revenues also enduring to Omeros. Both the U.S. and international royalty rates paid to Omeros should remain until the expiration of OMIDRIA patents, which are slated to be no sooner than 2033. So having laid out the current strength of our financial position, let’s now turn to updates on Omeros’ programs, beginning with narsoplimab in stem-cell transplant associated thrombotic microangiopathy or TA-TMA.

Following our appeal of FDA’s complete response letter on our biologic license application or BLA, narsoplimab in TA-TMA, in late 2022, we received guidance from FDA’s Office of New Drugs, proposing a path forward to resubmit our BLA with additional analysis comparing response from our completed pivotal trial to a threshold derived from an independent literature analysis. Also requested was evidence of increased survival in our completed trial compared to an appropriate historical control group. We have identified and now can access robust sources of independent and historical response rates and survival in TA-TMA patients not treated with narsoplimab. Working with our regulatory and legal advisers led by Hyman Phelps & McNamara toward a rapid resubmission of our BLA, we have requested a meeting with the FDA’s Division of Non-Malignant Hematology to discuss the details of our proposed analyses and to confirm the information required by FDA and to support narsoplimab’s approval.

This will be a Type B meeting, so we expect it to occur in the first half of the second quarter. For European approval, we have initiated clinical trials assessing narsoplimab in pediatric patients with TA-TMA to fulfill our pediatric investigation plan agreed with the European Medicines Agency or EMA. We expect to complete the submission of our marketing authorization application to EMA after resubmission of our BLA. Since our last earnings call, we have seen continued and substantial activity in peer-reviewed publications and presentations directed the TA-TMA, the lectin pathway and narsoplimab. In international group of leading transplanters recently published a systemic review of signs and symptoms of TA-TMA in transplantation and cellular therapy.

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And a second manuscript on TA-TMA diagnosis and treatment has been accepted for publication by the journal Bone Marrow Transplantation. Presentation at the recent Annual Meeting of the American Society of Hematology detailed our clinical trial of narsoplimab in pediatric patients with TA-TMA and two additional abstracts on use of narsoplimab in TA-TMA have been accepted for presentation at the upcoming European Society for Blood and Marrow Transplantation. Stem-cell transplanters internationally are increasingly identifying TA-TMA and their transplant patients and recognizing it as an urgent and unmet medical need. National diagnostic and procedural billing codes now officially recognize TA-TMA as a discrete complication of stem-cell transplantation.

This means that once there is an approved treatment for TA-TMA off-label use, which occurs now with C5 inhibitors should be rightly curtailed, further driving use of any approved treatment. We believe that narsoplimab deserves FDA approval for the treatment of TA-TMA and we are committed to continuing to work with FDA to make that a reality. Also in our narsoplimab portfolio, our Phase 3 clinical trial in patients with IgA nephropathy remains on track to read out nine-month proteinuria data in the third quarter of this year. This is expected to form the basis for our BLA to be submitted to FDA and we expect for our submission to European Regulators. Adding to a list of existing publications, a manuscript authored by a group of international experts on the role of the lectin pathway and the pathophysiology of IgA nephropathy has been submitted to a leading peer-reviewed journey.

IgA nephropathy represents a multibillion-dollar market opportunity, while FDA has recently approved for IgA patients in both a steroid and a representative of a new class of agents that target blood pressure. Clinical experts do not see these as competitors, but rather as complementary to inhibitors of the complement system. There currently is no complement inhibitor approved for IgA nephropathy and we aim to make narsoplimab the first. As we have discussed in previous calls, our Phase 3 program in atypical hemolytic uremic syndrome or aHUS, remains a low priority. Enrollment has been challenging and due to what we and others see as a contracting commercial market for aHUS because of the increasing number of C5 biosimilars, we have diverted resources to other clinical programs within our complement franchise.

At our labs in the University of Cambridge, collaborative work with multiple U.K. consortium and acute severe and long COVID is advancing. Dialogue is ongoing with relative branches of the U.S. Government and with the resurgence of COVID and related diseases, there is continued interest from these agencies in accessing narsoplimab and funding narsoplimab related activities. A manuscript directed the lectin pathway inhibition and well-established in vitro in animal models of both COVID and influenza-related acute respiratory distress syndrome or ARDS is being prepared for submission. The evidence supporting the central role of the lectin pathway and the utility of narsoplimab in these diseases is only increasing. This is being further highlighted within government agencies as the utility of vaccines under increasing scrutiny becomes more questionable and the need for therapeutics that directly target the central pathophysiology of COVID and other causes of ARDS moves to the forefront.

Now let’s look at OMS1029, our long-acting next-generation antibody targeting MASP-2 and the lectin pathway. OMS1029 is complementary to narsoplimab. Whereas narsoplimab is generally administered intravenously once weekly, ideal for acute or episodic treatment, long-acting OMS1029 is designed for chronic use. Our strategy of developing OMS1029 is a long-acting follow-on to narsoplimab is to enable Omeros to control first-line therapies for the large majority of lectin pathway related disorders. In January of this year, we completed dosing of all cohorts in the OMS1029 single ascending dose Phase 1 clinical trial. As predicted, given our experience with narsoplimab, OMS1029 was well tolerated with no safety concerns identified. The trial did deliver excitement, though, and that the pharmacokinetic and pharmacodynamic data demonstrate that OMS1029 effectively ablates lectin pathway activity and should do so even with markedly protracted dosing intervals of once quarterly administration.

Detailed results from the single ascending dose study of OMS1029 are planned for presentation at an upcoming scientific congress. Dosing in the OMS1029 multiple ascending dose study in healthy subjects is scheduled to start this summer. Wrapping up our lectin pathway portfolio, we believe that we are very close to selecting a lead drug development candidate from our small molecule orally active MASP-2 inhibitor program. Recent pharmacokinetic and pharmacodynamic data are compelling and safety data generated to-date are clean. Together with our external advisers, including former heads of chemistry, pharmacokinetics and drug metabolism at GlaxoSmithKline and Merck, we are enthusiastic about these molecules and hope to select a lead compound next quarter.

A successful orally dosed small molecule inhibitor of MASP-2 together with narsoplimab and OMS1029 should enable Omeros to control the gamut of diseases and disorders caused by dysregulation of the lectin pathway. We will now complete the updates on our complement franchise with OMS906, our antibody targeting MASP-3. MASP-3 is the key activator of the alternative pathway of complement. As previously announced, we successfully completed a single ascending dose Phase 1 study of OMS906 evaluating both intravenous and subcutaneous administration in healthy subjects. The drug was well tolerated and there were no safety signals of concern. Detailed clinical data from that study were presented in December at the Annual Meeting of the American Society of Hematology.

Based on clinical data to-date, we expect that we will be able to achieve once quarterly dosing with OMS906 either intravenously or subcutaneously. This along with the other potential differentiating benefits of OMS906 should serve us very well in the competitive marketplace of alternative pathway inhibitors. Our clinical development strategy is to obtain rapid proof-of-concept data on the efficacy of OMS906 in multiple validated alternative pathway related disorders, including Paroxysmal Nocturnal Hemoglobinuria or PNH and complement 3 glomerulopathy or C3G. On schedule, last December, we began enrolling treatment-naïve PNH patients in one of our Phase 1b clinical trials evaluating OMS906 and dosing began early this year. Our second Phase 1b clinical trial, this one in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab is also enrolling.

We are scheduled to begin the first dosing of OMS906 in this study later this month once the ravulizumab monotherapy period has ended. The current development plan for OMS906 and PNH involves a pivotal program consisting of two trials, one in treatment-naïve patients and one in patients who don’t respond well to improve PNH therapy, both with relatively small numbers of patients similar to the numbers enrolled for Novartis’ iptacopan and APPLAUSE’s like iptacopan programs. We have also initiated a Phase 1b clinical trial evaluating OMS906 in patients with C3G. Enrollment here is expected to commence next month with data available in the third quarter of this year. Here again, we are planning for relatively small study population similar to the number of C3G patients being enrolled by Novartis for iptacopan.

Regulatory interactions in the U.S. and Europe are ongoing for OMS906 in both PNH and C3G. As discussed earlier, there is good evidence that MASP-3 and 906 could prove to be the premier target and drug, respectively, in the alternative pathway. The potential advantages of OMS906 over other alternative pathway inhibitors on the market or in development include safety, through a meaningfully decreased infection risk by not blocking the adaptive immune response, compliance and convenience with significantly better dosing profile and once quarterly intravenous or subcutaneous administration and efficacy through greatly decreased risk and breakthrough of the underlying disease given that MASP-3 first is not an acute phase reactant and that OMS906 has a long half life, allowing MASP-3 to be blocked consistently and effectively.

These advantages are well recognized by scientific and clinical experts across both academia and industry. The question that remains is whether MASP-3 inhibition and specifically OMS906 can demonstrate efficacy in any alternative pathway disorder. If it does, then the widely held expectation is that OMS906 will be efficacious across the full scale of alternative pathway-associated diseases and disorders. This is particularly true if we demonstrate efficacy in PNH, which because of the severity of the disease, sets a very high bar for alternative pathway ambition. But efficacy in any alternative pathway disorder should readily allow a value calculation of the OMS906 program based on predicate alternative pathway drugs in programs such as C3, Factor B and even C5 inhibitors.

Should OMS906 demonstrate efficacy, we are confident that the safety, compliance and convenience and efficacy advantages that I described just a minute ago, would significantly differentiate OMS906 from those predicate alternative pathway inhibitors and others in development. Again, based on the science and evidence to-date, we believe that MASP-3 is the premier target, and by extension and because of its attributes, OMS906 has the potential to be the premier drug in the alternative pathway market. So we look forward to sharing publicly clinical data from our OMS906 program. Turning now to OMS527, our PDE7 inhibitor program, discussions continue regarding third-party funding for continued development of OMS527 as a treatment for addictive disorders.

As has been widely and frequently broadcast, addiction is an enormous and worsening problem in the U.S. and worldwide. In the U.S. alone, in 2019, tangible measured cost of substance use were $0.5 trillion. With intangible costs such as loss of life, injury, reduced quality of life, all of those estimated at a staggering $3.2 trillion annually. With the Centers for Disease, Control and Prevention, reporting that one in seven Americans 12 years of age or older have experienced a substance use disorder. A therapeutic that could treat the cause of abuse could change the lives of tens of millions of patients just in the U.S. We look forward to securing external funding and moving ahead with further clinical development of OMS527. In addition to the wide field of addiction and compulsion disorders, Omeros also control broad intellectual property directed to PDE7 inhibition for the treatment of movement disorders.

With collaborators at Emory University, we are evaluating OMS527 as potential treatment for L-DOPA induced dyskinesias or LID. These dyskinesias are crippling involuntary movements in Parkinson’s patient cause in part and ironically by prolonged treatment with L-DOPA, the most prescribed and most effective therapy for Parkinson’s. More than 10 million patients are living with Parkinson’s worldwide and reportedly 50% or more of those treated with L-DOPA suffer from living. Only one drug, extended-release amantadine is approved for the treatment of LID and it has limited efficacy with multiple significant adverse effects. Here again, LID represents a large unmet patient need and a substantial market opportunity. Data to-date in a clinically predictive primate model of LID have been encouraging.

We await data from one additional primate, which took longer to develop LID than anticipated by our Emory collaborators. Treatment with our PDE7 inhibitor is underway and data are expected next month. We will close the update today with our immuno-oncology programs. These are platform programs for both cellular and molecular therapies for cancer. All are derivatives of our work on GPR174, our proprietary target in cancer immunity. For cellular therapies, we have developed and are evaluating novel approaches for both CAR T and adoptive T-cell therapies. We have identified specific T-cell signaling pathways, which once inhibited significantly and preferentially enhance the expansion of memory T-cells that distinctively recognize and efficiently kill tumor cells.

Our team is validating these model approaches and establishing a broad position. We believe that the proprietary cellular technologies could markedly improve response rates for cancer patients receiving either engineered or native T-cell therapies for both liquid and solid tumors. On the molecular front, we have developed novel biologic platforms to target specifically and kill cancer cells. We expect that some of these biologics will function as therapeutic vaccines against a broad range of tumors. Successful development of therapeutic cancer vaccines were widely pursued, have proven difficult to achieve with the current industry approaches, inducing only transient and ineffective immune responses. We believe that we have overcome this challenge.

Having now engineered novel molecules that combine tumor antigens with a potent adjuvant, these combinations show high levels of killing in cancer cells and demonstrate the potential to transform the treatment of both solid tumors and hematological cancers. Here again, we are constructing a broad intellectual property state around these multiple immunotherapy platforms. With that, I will turn the call over now to Mike Jacobsen, our Chief Accounting Officer, who will go through a more detailed discussion of the financial results for the fourth quarter and the year. Mike?

Mike Jacobsen: Thanks, Greg. As Greg discussed, in December of last year, Rayner required OMIDRIA and associated business operations. The sale required us to restate our financial statements for all periods into continuing operations and discontinued operations. Our net income for the fourth quarter was $128.7 million or net income of $2.05 per share, compared to a loss of $17.5 million or $0.28 per share in the third quarter of 2022. The fourth quarter includes the $200 million milestone we earned from Rayner in December, which is included in discontinued operations. If we look at just continuing operations, our net loss for the fourth quarter was $0.73 per share, compared to a net loss of $0.87 per share in the third quarter, a $14 improvement.

At year end, we had $195 million of cash and investments on hand and $213 million in receivables, all of which we have collected. The $213 million year end receivable balance includes the $200 million in payment, as well as the OMIDRIA royalties for November and December, which are due 60 days after respective month ends. We therefore had approximately $408 million in cash available for operations and debt service when you add the cash and investments together with the receivables. Cost and expenses from continuing operations for the fourth quarter were $40 million, which is a decrease of $10.6 million from the third quarter. The decrease was primarily due to manufacturing commercial narsoplimab drug substance in the third quarter, which we expected given that we do not have FDA approval.

As we finalize our path forward for TA-TMA, we continue to gauge our narsoplimab’s sales and marketing spend until the timing of FDA approval is clear. Interest expense for the fourth quarter was $7.9 million, compared to $4.9 million in the third quarter. The $3 million increase is due to interest on the DRI agreement which we entered on September 30th of this year. Now let’s look at OMIDRIA royalties. As I have mentioned previously, royalties earned are recorded as a reduction in the OMIDRIA contract royalty asset on our balance sheet. Since the sale of OMIDRIA in December of 2021, we have been receiving royalties of 50% of U.S. net sales of OMIDRIA. Upon the achievement of the $200 million milestone on December 29, 2022, OMIDRIA royalties decreased to 30% of U.S. net sales.

The 30% royalty equates to approximately 40% of U.S. OMIDRIA operating profit considering the OMIDRIA operating expenses we no longer have to pay. The 30% royalty rate extends for the duration of the relevant patent terms, which we expect to be at least through 2033. For the fourth quarter, our 50% royalty on Rayner net sales was $17.9 million on sales of $35.8 million. The $35.8 million is a $2 million increase in net sales over Q3 and establishes a new all-time high for a OMIDRIA quarterly sales. Income from discontinued operations in the fourth quarter includes four key components, the $200 million milestone payment, $4.9 million of interest earned on the OMIDRIA contract royalty asset, $26.2 million of expense due to the re-measurement adjustments to the OMIDRIA contract royalty asset and state income tax expense of $4 million.

We do not owe any federal income tax due to the utilization of a portion of our outstanding net operating losses. Re-measurement of the contract royalty asset is primarily due to the reduction of future OMIDRIA royalties when the rate was reduced from 50% to 30% of net sales. Now let’s take a quick look at our first quarter expected results. We expect overall operating costs from continuing operations in the first quarter to remain relatively consistent in the fourth quarter. Interest income should be nearly $3 million and interest expense for the first quarter should be consistent with the fourth quarter at approximately $8 million. Income from discontinued operations should be in the $7 million to $8 million range. With that, I will turn the call back over to Greg.

Greg?

Dr. Greg Demopulos: Thanks, Mike. Operator, why don’t we open the call to questions.

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Q&A Session

Operator: And thank you. And one moment for our first question. And our first question comes from Colin Bristow from UBS. Your line is now open.

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

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

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

Colin Bristow: Got it. Thank you.

Dr. Greg Demopulos: And I will — okay. Great. Thank you.

Operator: And thank you. And one moment for our next question. And our next question comes from Steve Brozak from WBB Securities. Your line is now open.

Steve Brozak: Hi. Thanks for taking the question. Just one quick one. Can you go into and give us much detail on your diagnostic collaboration with Cambridge and what can you tell us about what kind of data you are seeing there and what are the ramifications from that? And I will jump back in the queue. Thank you.

Dr. Greg Demopulos: Yeah. We will be publishing more data, Steve, coming out of Cambridge, so I don’t want to preempt that. But with respect to the diagnostics, specifically, what we have identified is a pattern of complement factor changes that occur with severe acute COVID and even moderate COVID. But hospitalized COVID patients that specifically linked to the lectin pathway and we are in discussions with government agencies around that panel of assets that we are working through. This may also have applicability to long COVID or past, but it is, I think, currently premature to make any definitive statements about the

Steve Brozak: Got it. Okay. Thanks very much. Let me hop back in the queue.

Dr. Greg Demopulos: All right, Steve.

Operator: And thank you. And one moment for our next question. And our next question comes from Greg Harrison from Bank of America. Your line is now open.

Mary Kate: Hi, there. It’s Mary Kate on for Greg. Congrats with the milestone payment and thanks for taking our question. I guess looking at the narsoplimab program here in IGAN and given the Phase 3 data expected, what are your commercial expectations for narsoplimab is approved in this indication? Thank you.

Dr. Greg Demopulos: Well, we think the opportunities for narclumab is lot. As I said, the IGAN market is a large market. It’s a multibillion-dollar opportunity as you know. And what’s been approved in orally available steroid, one that works primarily within the gut and an agent that is another approach to blood pressure control. But what we are talking about with narsoplimab specifically, is an anti-complement agent. And we think the utility of that could be substantial particularly in patients with high proteinuric, so patients with high levels of protein spillage in the urine. And when I say that, I mean, those patients somewhat arbitrarily, but those patients who have 24-hour urine proteins of 2 grams or more per day. We think that there is a very large opportunity for the treatment of those patients, as well as those with lesser degrees of proteinuria and we think that, certainly, there’s a need for complement inhibition and specifically lectin pathway inhibition.

As I think we have discussed before, lectin pathway inhibition is important not only at the glomerular, but also in the tubular endothelium, and as you know, that is where all end-stage proteinuric renal diseases pass. So really if you can affect the tubular interstitial, you are effectively treating or potentially treating all proteinuric renal disease. So we think the opportunity is very large.

Mary Kate: Great. Thank you.

Operator: And thank you. And one moment for our next question. And our next question comes from Brandon Folkes from Cantor. Your line is now open.

Brandon Folkes: Hi. Thanks for taking my question and congratulations on all the progress. I just want to come back to that first question around narsoplimab and the TA-TMA meeting with the FDA. Is there a way to contextualize sort of the level of work you have done ahead of this meeting? And what I mean for that is, if you do have a meeting of the minds on the approach to sort of addressing the CRL, is this something we should expect a submission relatively shortly thereafter or is it more just going to agree on an approach and then it could be a couple of months or quarters of work behind it?

Dr. Greg Demopulos: Yeah. Let me first say that, in the prepared comments, I think, I made it clear that we have identified and now can access the sources of information that we need or we believe we need to address FDA’s concerns. So I think it would be premature though on the front end of that FDA meeting to talk about how long it will take us to satisfy FDA. Let’s get through the meeting first and then I think we can speak more definitively about that, otherwise it’s pure speculation. But I think part of your question is what have we been doing, and certainly, in the meantime, since our last public statement around this, there’s been a tremendous amount of work being done; one, in identifying those sources of information; two, obtaining access to those.

Certainly, we aren’t running analysis upfront, because we want to make sure that we with FDA agree one analysis we are going to run. But then, I think, running them, if we are all in agreement on what we are doing, should not be a lengthy process. But let me see, again, I will ask Cathy and/or Steve, if you have any other comments on this.

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

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

Dr. Greg Demopulos: Yeah. Sure. Thanks again, Brandon. Well, certainly, our focus on narsoplimab is a high priority, similarly, our focus on 906. I think as we made clear we began enrolling last December, we began dosing in January. We are pushing hard on that program. We think that that’s going to be a very important program not only for us, but for patients with alternative pathway disorder. So that’s a priority. When we kind of march down, you look at OMS1029, which is our backup to narsoplimab, that program is sailing through, everything looks good there. Similarly, the small molecule program, let’s see if we select, if we select a development candidate next quarter, we will be looking at advancing that. But as you know, that’s really a lot of pre-IND work and that’s pretty contained with respect to cost.

527, we are looking for external funding, and once we have that, assuming we get it, we expect that to fund clinical work and further development. If we turn over a positive card the levodopa-induced dyskinesias. That’s another area that we would consider a clinical trial. But again, that would be limited in size first. It would be proof-of-concept, so cost would be pretty contained. Then when you look at our immuno-oncology programs, those are preclinical, but we hope to, over the coming months, be able to start to move one or more of them into IND-enabling work, which again, those costs are pretty contained. So I think I have answered your question, but let me be very specific about it. All of the programs I have just mentioned are laid out there for the budget and fall within what we are doing all the way well into 2025.

Brandon Folkes: Okay.

Dr. Greg Demopulos: Again, based

Brandon Folkes: Great. Thank you very much.

Dr. Greg Demopulos: Yeah. Based on where we see success, we can always push the hammer down even more on those specific programs. But we are looking for additional revenue beyond OMIDRIA coming in and continuing to drive further development of the pipeline.

Operator: And

Brandon Folkes: Thank you very much.

Operator: And thank you. And one moment for our next question. And our next question comes from Serge Belanger from Needham & Company. Your line is now open.

Serge Belanger: Hi. Good afternoon. A couple of questions for us, the first one on the ARTEMIS Phase 3 trial that I think is expected to read out in the third quarter of this year. Greg, I think, you mentioned that, you expect this trial to support the BLA filing. Just curious when you would expect that the BLA filing, assuming that we get positive results in the third quarter. What kind of other data would you need to complete that filing?

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

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

Dr. Greg Demopulos: Thanks, Steve.

Cathy Melfi: Yeah. And

Serge Belanger: Okay. So you could have — go ahead.

Cathy Melfi: The topline data — once we have the topline data, that kind of what triggers the pre-BLA meeting with FDA and so I concur with the timing that Greg had proposed.

Serge Belanger: So there would be no issues in having two separate BLA filings, one for just the TA-TMA and another one for IgA nephropathy?

Dr. Greg Demopulos: Yeah. You are talking about, I think, resource allocation and workload. We — remember that we are looking for Q3 data on IgA. So we would expect that they would blend well. But, Steve, this is partly your group as well. So why don’t you address this?

Steve Whitaker: We have identified resources we need so they can run it fairly well and there’s overlap between the two as well. So I wouldn’t see any one blocking the other.

Dr. Greg Demopulos: Thanks, Steve.

Serge Belanger: Got it. And then a couple on OMIDRIA.

Dr. Greg Demopulos: Sure.

Serge Belanger: Now that the — you have gotten the milestone payments and the royalty rates knocked us down from 50% to 30%. Does that have any implication for DRI royalty agreements and respectively

Dr. Greg Demopulos: No. Not at all. Yeah. Let me just answer that first. No. I think our agreement with DRI, frankly, anticipated. Our success in achieving a milestone and DRI was and is very aware of that 30%. But we also — all of us, I think, DRI included expect overall sales to continue to increase with the legislative successes that have been achieved for all non-opioid pain management drugs and also as we start to focus on, I hope, Med Advantage as well.

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

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

Mike Jacobsen: No. I think, Rayner’s obviously looking at it, they are very aware that we have gotten the milestone and preserve the long-term payments and the HOPD side increases the potential there as well. So I think Rayner is really aware of the opportunities they have sitting there.

Dr. Greg Demopulos: There’s a tremendous opportunity as well on the Med Advantage side.

Mike Jacobsen: Yeah.

Dr. Greg Demopulos: And I think I am sure that Rayner realizes that and is focused as they should be on expanding Med Advantage payments, not just coverage, but payment. And there are ways, I think, that the Congressional action can carry through and we have looked at that as well, that that can carry through to Med Advantage and help educate the Med Advantage payers, which often are the same payers as commercial as to why they should be separately paying for OMIDRIA in the same way that Congress has mandated CMS too.

Serge Belanger: Yeah. Thanks.

Dr. Greg Demopulos: All right, Serge.

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

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

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.