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Edited Transcript of OMER earnings conference call or presentation 11-May-20 8:30pm GMT

Q1 2020 Omeros Corp Earnings Call

SEATTLE Jun 8, 2020 (Thomson StreetEvents) -- Edited Transcript of Omeros Corp earnings conference call or presentation Monday, May 11, 2020 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Gregory A. Demopulos

Omeros Corporation - Co-Founder, Chairman, CEO & President

* Michael A. Jacobsen

Omeros Corporation - CAO, VP of Finance & Treasurer

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Conference Call Participants

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* Brandon Richard Folkes

Cantor Fitzgerald & Co., Research Division - Analyst

* Stephen Gilbertpaul Brozak

WBB Securities, LLC, Research Division - Senior Equity Analyst

* Jennifer Williams;Cook Williams Communications, Inc.;Investor and Media Relations

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Presentation

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Operator [1]

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Good afternoon and welcome to today's earnings call for Omeros Corporation.

(Operator Instructions)

Please be advised that this call is being recorded at the company's request, and a replay will be available on the company's website for one week from today.

I'll turn the call over to Jennifer Williams, Investor Relations for Omeros.

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Jennifer Williams;Cook Williams Communications, Inc.;Investor and Media Relations, [2]

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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 Risk Factors section in 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 2019 annual report on Form 10-K for a discussion of these risks and uncertainties. Dr. Greg Demopulos, Chairman and CEO of Omeros, will take you through a corporate update; and then Mike Jacobsen, our Chief Accounting Officer, will provide an overview of our first quarter financial results. We have some time reserved for questions after the financial overview. Now I would like to turn the call over to Dr. Demopulos.

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Gregory A. Demopulos, Omeros Corporation - Co-Founder, Chairman, CEO & President [3]

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Thank you, Jennifer, and good afternoon, everyone. We appreciate you joining us for today's update. We hope that all of you and your families are safe and healthy. And we would like to start by acknowledging and thanking all those on the front lines in this global battle against SARS CoV2. Every day, first responders and health care providers are risking their lives and the lives of their loved ones to help patients with COVID-19 and to protect the rest of us from this disease. We recognize and greatly appreciate their efforts and selflessness.

At Omeros, our employees have remained safe and healthy, consistent with our governor's guidelines. Most of our team members are working and functioning productively from home.

Our researchers who primarily work in the labs continue to do so, implementing appropriate precautions to ensure their safety and the safety of their coworkers. The distillate of all this is that the Omeros team has been able to continue advancing our programs. We'll begin with an update on narsoplimab and our progress toward the drug's planned commercialization.

Narsoplimab is our fully human antibody targeting the lectin pathway of complement and specifically MASP-2. Omeros exclusively controls MASP-2 and all therapeutics targeting the enzyme. Our lead indication for narsoplimab is hematopoietic stem cell transplant associated thrombotic microangiopathy or transplant TMA, which is caused by endothelial injury. Endothelial injury and cellular damage broadly activate the lectin pathway of complement. By blocking MASP-2, which is the lectin pathways effector enzyme, narsoplimab inhibits the lectin pathway.

We resolved the historical data collection issue that we referenced during our last earnings call, and we continue driving toward completing the submission of our rolling Biologics License Application, or BLA, for narsoplimab and transplant TMA next quarter. At the end of last year, we began our rolling BLA with the submission of the nonclinical sections. We just submitted on schedule, the first components of our chemistry, manufacturing and controls, or CMC sections. These include data on manufacturing, analytical procedures and associated method validations. As we reported during our last earnings call, we successfully completed manufacturing of all drug substance, process validation lots that FDA requires for the BLA, and now we also have successfully completed manufacturing of all of the required drug product process validation lots.

The remaining CMC information and clinical sections are underway and constitute the final sections of our BLA. Given our breakthrough therapy designation, we expect that FDA will grant our BLA priority review, which could further shorten the time to approval. We are also pulling together the information for our European marketing authorization application, which will be submitted after we expect FDA approval.

Narsoplimab continues to increase its visibility and standing within the stem cell transplant community. In February, at the Transplant and Cellular Therapy, or TCT, annual meetings in Orlando, Omeros sponsored a continuing medical education session on thrombotic microangiopathy chaired by Dr. Samer Khaled, Medical Director of Hematology and Stem Cell Transplant Clinical Operations at City of Hope. The speaker panel included Dr. Sergio Giralt, Deputy Head of the division of Hematologic Malignancies at Memorial Sloan Kettering Cancer Center; Dr. Sonata Jodele, Professor of Pediatrics in the division of bone marrow transplantation and immune deficiency at Cincinnati Children's Hospital; and Dr. Chris Dandoy, Assistant Professor of Clinical Pediatrics and a bone marrow transplant specialist also at Cincinnati Children's. The symposium was well attended and focused on transplant TMA and potential therapies.

In mid-June, data from the narsoplimab pivotal trial and transplant TMA will be presented at the annual and now also virtual meeting of the European Hematology Association, or EHA. Selected by conference leadership for a podium presentation, the data will be discussed by Professor Alessandro Rambaldi of the University of Milan and Director of the Department of Hematology/Oncology at Papa Giovanni XXIII Hospital. Our interactions with opinion leaders continue to strengthen through advisory boards and our support of educational activities around transplant TMA. Omeros is also providing support for a working group of the nation's leading transplanters who are developing for the first time guidelines for the diagnosis of transplant TMA. Commercial preparations continue as our rolling BLA submission nears completion. We have developed a narsoplimab value story and are conducting market research with transplant physicians, administrators and payers. We're finalizing our distribution and pricing strategies as well as our profiling activities to ensure a well-designed and executed launch for narsoplimab in transplant TMA.

As part of those efforts, we recently hired our National Sales Head from Jazz Pharmaceuticals, our National Director of Medical Science Liaison from Amgen and our Advocacy Lead who joined us as a practicing health law attorney and was previously at Amgen and Fred Hutchinson Cancer Research Center.

As we did for OMIDRIA, these new leaders are helping us build a top-tier seasoned team to launch narsoplimab.

In addition to transplant TMA, we're also assessing expansion of narsoplimab into other endothelial injury syndromes such as diffuse alveolar hemorrhage graft-versus-host disease and others. Our efforts here are supported by our opinion leader advisers and the recent focus on endothelial injury associated with COVID-19 has underscored the importance of MASP-2 and the lectin pathway in the pathophysiology of diseases caused by endothelial injury.

While we're focused on obtaining approval for narsoplimab in transplant TMA, we also have 2 Phase III programs for narsoplimab. One in IgA nephropathy and the other in atypical hemolytic uremic syndrome, or aHUS. Consistent with FDA guidelines and with recommendations of the independent data safety monitoring committee for Omeros regarding ongoing clinical trials during the COVID-19 pandemic, study sites are conducting trials in a manner consistent with local guidelines and/or regulations to maintain safety of study patients and investigators. As a result, at some sites, new patient enrollment has slowed, while previously enrolled patients are continuing the trials.

For our ARTEMIS-IGAN Phase III trial, we had already implemented procedures for home infusion of narsoplimab and are expanding this capability across additional sites. Other measures to protect the safety of our clinical trial participants, such as remote monitoring visits and access to local laboratory facilities, are also in place at a good number of these sites.

The primary endpoint in the ARTEMIS-IGAN trial is change in proteinuria at 36 weeks. Based on discussions with FDA, we have the ability to receive full regulatory approval for narsoplimab in IgA nephropathy based on assessing proteinuria rather than also needing to wait 1 to 2 years longer to assess the change in glomerular filtration rate. We also are able and the protocol is written to assess the proteinuria endpoint in each of 2 different populations: in the overall patient population with more than 1 gram of proteinuria per day and in the subset of patients with at least 2 grams of proteinuria per day. Either population can yield accelerated or full approval. To the best of our knowledge, narsoplimab is singularly unique among the drugs in development for IgA nephropathy in its ability to receive full approval on proteinuria alone.

We continue to target data readout on the proteinuria primary endpoint from the ARTEMIS-IGAN trial next year.

A manuscript authored by Professor John Barrett and others at the University of Leicester, describing the beneficial effects of narsoplimab in IgA vasculitis associated nephritis, a rapidly progressive glomerulonephritis was accepted for peer-reviewed publication and will soon be published.

A second manuscript has also undergone review and is expected to be published soon. Authored by Omeros' IgA nephropathy academic leadership committee members, comprised of international thought leaders, the manuscript presents our Phase II clinical data.

Turning now to our commercial product, OMIDRIA, net sales in the first quarter were $23.5 million. This is below our historical run rate and is due to the nationwide hiatus in elective surgery, such as cataract surgery as part of the COVID-19 related public health emergency.

The net effect of the COVID-19 elective surgery shutdown on first quarter OMIDRIA revenues is that of the 5 weeks of potential sales in March, we were able to recognize sales from only 1 of those 5 weeks. For context, March typically accounts for about 45% of total first quarter revenues.

As a result, our net loss for the first quarter of 2019 was $29 million or $0.53 per share. This includes noncash expenses of $6.4 million or $0.12 per share.

As of March 31, 2020, we had $54 million of cash and investments available for general operations. We also have an accounts receivable baseline of credit with Silicon Valley Bank. The line of credit enables us to borrow up to the lesser of 85% of our outstanding eligible accounts receivable balance or $50 million. We have not borrowed under this line of credit.

Historically, Q1 is the slowest quarter of the year for cataract surgery. OMIDRIA sales traditionally ramp up significantly in March. And as I just noted typically account for about 45% of total first quarter revenues. Given the first quarter effects of COVID-19 on cataract surgery, we're pleased with the Q1 revenue performance by OMIDRIA.

Further good news is that COVID-19 related restrictions on elective surgery have begun lifting. So far, hospitals and ambulatory surgery centers in 36 states have already resumed ordering OMIDRIA from the wholesalers. Most centers are beginning with a limited number of procedures and will continue expanding to meet the substantial backlog of patients waiting for surgery. In the states where COVID-19 related restrictions have not yet been lifted, elective surgery is expected to be among the first activities reinstated. We've been working closely with our accounts to prepare for the impending increase in cataract surgery and the anticipated increase in demand for OMIDRIA.

Our conversations with top opinion leaders and surgeons indicate that as soon as possible, they will lengthen their surgical days to operate into evenings, and that they will also expand the number of weekly operating days to include weekends to manage the backlog and the pent-up demand of patients awaiting surgery, which we expect could surpass historical levels. Prior to the COVID-19 related shutdown of cataract surgery, physicians and facility adoption of OMIDRIA remained on its upward trajectory.

In Q1, there were 62 first-time OMIDRIA buyers, evenly split between hospitals and ASCs. This represents a 17% quarter-over-quarter increase in the number of new OMIDRIA accounts. We also are expanding our customer base to include large private equity groups as consolidation of surgical practices and facilities continues.

In Q1 alone, we signed 2 large private equity groups to new contracts, representing more than 55,000 cataract procedures annually. And we're currently working to secure OMIDRIA use across several other large ASC groups as well.

The growth in our customer base has also been helped by our recently received HCPCS J-code for OMIDRIA, which is now fully implemented. Our J-code has improved reimbursement, standardizing payment across Medicare, Medicare Advantage, Medicaid and commercial insurance plans. Under pass-through, Medicare Part B is uniformly reimbursed at ASP plus 6% by CMS, and in addition, we continue expanding reimbursement across Medicare Advantage and commercial payers.

The increasing uptake of OMIDRIA by surgeons and facilities has been further accelerated by the growing volume of peer-reviewed publications documenting the expanding benefits of OMIDRIA.

Compelling clinical data continue to drive physician adoption as the value story for OMIDRIA strengthens and solidifies. OMIDRIA is the only FDA-approved product that prevents miosis and reduces postoperative pain. It's prevention of intraoperative floppy iris syndrome, reduction in complication rates and avoidance of the need for steroids add to the many reasons that surgeons are increasingly using OMIDRIA for their patients. Two additional studies demonstrating the benefits and safety profile of OMIDRIA were recently published in the peer-reviewed Journal of Cataract and Refractive Surgery. The first article detailed the results of a retrospective study that found that patients who received OMIDRIA had significantly lower incidences of sight-threatening cystoid macular edema, breakthrough iritis and pain compared to a control group receiving conventional perioperative steroids.

The second presented the data by which FDA concluded that OMIDRIA is safe to use in children, expanding the FDA-approved label to all cataract surgery patients.

This randomized, double mass study in 72 pediatric patients showed that OMIDRIA was not only safe in children ages 0 to 3 years undergoing cataract surgery, but also resulted in statistically significant lower pain scores. As we previously discussed, another recent publication in the Journal of Cataract and Refractive Surgery demonstrated that OMIDRIA reduces the need for fentanyl, a highly potent and addictive opioid during cataract surgery, while simultaneously delivering improved outcomes, lower validated pain scores and fewer complications. To assess the effect of OMIDRIA on postoperative opioid use, an analysis of claims data over a 3-year period was performed by IBM Watson Health. Claims data were evaluated from 219,000 patients, 65 years of age or older who underwent cataract surgery. To avoid potential confounding by recent opioid use or dependence, all patients were required to have no opioid use during the 6 months prior to surgery.

Filled opioid prescriptions in the OMIDRIA-treated group were compared to those in the non-OMIDRIA treated group. The findings were remarkable.

Patients who received OMIDRIA during surgery received fewer opioid pills during the 2 days and 7 days post surgery than patients who did not receive OMIDRIA.

The median reduction seen was 56%, specifically 20 pills versus 45 pills at 2 days with a p-value of 0.015 and 33%, 40 pills versus 60 pills at 7 days, with a p-value of 0.029. Sensitivity analysis yielded similar outcomes, underscoring the strength of the results. These data provide further evidence that OMIDRIA not only reduces the need for intraoperative fentanyl, but also decreases the use of postoperative opioids. The value proposition and clinical need for OMIDRIA are 2 of the reasons why we remain optimistic about continued separate payment for OMIDRIA beyond September 30 of this year, which applies specifically and only to Medicare Part B beneficiaries. The published data and physician experience with the product support are ongoing legislative and administrative efforts. The lockdowns in response to COVID-19 have created a number of hardships for families across the nation, not the least of which has been increasing opioid addiction.

The Non-Opioids Prevent Addiction in the Nation or the NOPAIN Act is a bill introduced in both chambers of Congress with increasingly strong bipartisan support. If enacted, it would provide separate payment for opioid-sparing treatments such as OMIDRIA for at least 5 years and would fix the disincentives that keep practitioners from prescribing non-opioid treatment alternatives in surgical settings. Just last Friday, a bipartisan letter signed by 16 members of the House of Representatives, many of whom serve on Energy and Commerce, a Committee of Jurisdiction over CMS was submitted to the House Democrat and Republican leadership, requesting the inclusion of the NOPAIN Act in the upcoming CARES 2.0 legislation.

Other administrative and legislative efforts are also progressing. While we remain optimistic that separate payment will continue, we are also working through scenarios to ensure that OMIDRIA will be a viable product that improves patient outcomes regardless of insurance payer, and that returns value to our shareholders even without separate payment from CMS for Medicare Part B beneficiaries.

Let's now turn to the rest of our pipeline, starting with our complement-related development programs beyond narsoplimab.

OMS906 is our fully human antibody targeting MASP-2, the enzyme believed to be the key activator and premier drug target in the alternative pathway.

Together with narsoplimab, OMS906, is a major part of our complement franchise. Among the broad range of alternative pathway disorders that are potential indications for OMS906, our initial focus is on paroxysmal nocturnal hemoglobinuria, or PNH. We've completed the human dose-enabled toxicology studies, which show no adverse effects even at the highest doses tested. The manufacturing scale-up process to support the remainder of the development program is well underway. We remain on track to submit a clinical trial application this quarter and expect to dose the first subjects in our Phase I trial in the first part of next quarter.

Rounding out our complement franchise, our longer-acting second-generation MASP-2 antibody as well as orally available small molecule inhibitors of MASP-2 and MASP-3. These are all part of our strategy for life cycle management of our complement franchise. We're targeting the initiation of clinical trials in 2022 for the longer-acting second-generation MASP-2 antibody OMS1029.

OMS527, our phosphodiesterase or PDE7 inhibitor program is also advancing. We're planning the Phase II program for OMS527, which is currently focused on nicotine addiction. In addition, we continue to make progress on our other development programs. We're increasingly excited about our GPCR program and GPR174, in particular, which we're working to bring to the clinic as soon as possible. We've shown that GPR174 controls a new cancer immunity axis that the receptor is linked to the tumor microenvironment and that GPR174 can suppress the body's antitumor response.

A tumor's ability to protect itself from the body's tumor-killing mechanisms is directly linked to the tumor microenvironment and has proven to be a major hurdle for cancer therapies to date, including checkpoint inhibitors. Despite this limitation, sales of checkpoint inhibitors exceeded $20 billion last year. We're developing inhibitors of GPR174, which represent a wholly new immunotherapy approach to overcoming the challenges inherent in the tumor microenvironment. In ex vivo and in vivo animal studies, our GPR174 inhibitors show substantial promise in doing just that. They also act synergistically with inhibitors of the adenosine pathway, another important immuno-oncology target.

We expect that our GPR174 inhibitors could be administered as single agents or in combination with adenosine pathway and/or checkpoint inhibitors to enhance the efficacy of those other agents.

With that, I'll turn the call over to Mike for an overview of our first quarter financial results. Mike?

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Michael A. Jacobsen, Omeros Corporation - CAO, VP of Finance & Treasurer [4]

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Yes. Thanks, Greg. As Greg noted, OMIDRIA in total revenues for the first quarter were $23.5 million, and our net loss was $29 million or $0.53 per share.

This includes noncash expenses of $6.4 million or $0.12 per share. As of March 31, 2020, we had $54 million of cash, cash equivalents and short-term investments available for general operations.

We also have an accounts receivable baseline of credit, which allows us to borrow up to the lesser of 85% of our available accounts receivable and $50 million.

Here are some additional details regarding our first quarter results compared to the fourth quarter of last year. Our revenue for the first quarter was significantly affected by the COVID-19 pandemic.

As Greg mentioned, in early March, OMIDRIA sales began to decrease due to the anticipated shutdown of elective procedures, including cataract surgery. The impact of this shutdown on Q1 revenues is significant given that approximately 45% of first quarter revenues occur in March. Given the impact on cataract surgery from the COVID-19 related elective surgery shutdown, we effectively recorded revenues from only 1 week out of the 5 weeks in March. Cost and expenses for the first quarter were $47.2 million, a decrease of $9.9 million from the fourth quarter of last year. As you may recall, we completed manufacturing a 5-drug substance lots at Lonza during the fourth quarter at a cost of $12.6 million. During the first quarter, we successfully completed the drug product process validation lots at Vetter, our fill/finish partner, that like our successful drug substance lots will satisfy the FDA's requirement for our BLA. This drug product will be used in our ongoing clinical trials of narsoplimab and be available for commercial sale following anticipated approval in transplant TMA. The financial results of these 2 activities is a net savings of approximately $12 million in our Q1 research and development costs compared to the fourth quarter of last year. As a reminder, until we receive approval for narsoplimab in transplant TMA, all CMC-related costs that would normally be included in inventory are being expensed as incurred. Going forward, we do not expect to incur similar costs until we build additional commercial inventory for narsoplimab in late 2020. Interest expense for the current quarter was $5.9 million and in line with our expectations.

Looking ahead to the second quarter of 2020, as we mentioned earlier, OMIDRIA sales in April were light due to the shutdown related to COVID-19. Beginning the first week in May, ASCs and hospitals in over 70% of the states began to perform cataract surgery again. But we cannot currently estimate how quickly surgical volume will return to historical levels and the overall impact on OMIDRIA revenues. Having said that, we understand that there is a significant backlog of cataract surgery cases that need to be performed.

And we expect the demand to drive historically high numbers of cataract surgery and likely OMIDRIA use as this backlog is worked through.

Our research and development expenses for the second quarter should be slightly higher than the first quarter of 2020. SG&A costs are expected to increase each quarter across the remainder of the year as we prepare for the launch of narsoplimab. With that, I'd like to turn the call back over to Greg. Greg?

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Gregory A. Demopulos, Omeros Corporation - Co-Founder, Chairman, CEO & President [5]

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Thanks, Mike. Let's open the call to questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

Your first question comes from the line of Steve Brozak from WBB.

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Stephen Gilbertpaul Brozak, WBB Securities, LLC, Research Division - Senior Equity Analyst [2]

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I only have two, and I'll hop back in the queue. On the OMIDRIA, obviously, information that you're giving us, you really can't provide estimates, and I understand that. And you've just given us some color on backlog. But can you -- given the fact that your systems are going out there and reaching to the clinicians, they're reaching out to the centers, can you give us any idea of what steps they're taking in terms of resumption of lens replacement and how that fits? And then -- as much color as you can give on that would be greatly appreciated. And then I've got one follow-up question on narsoplimab, please.

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Gregory A. Demopulos, Omeros Corporation - Co-Founder, Chairman, CEO & President [3]

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Sure. Thanks, Steve. With respect to OMIDRIA and cataract surgery and how surgeons are addressing this ramp-up again of cataract surgery, as I said, the groups are starting in a controlled way as with all sort of reentry here across not only cataract surgery, but I think all parts of our lives. The ramp-up is controlled at first. Their expectation is that they will ramp that up and extend, as I said, the hours of the surgical day and extend the number of operating days to move into the weekends as well.

And the reason for that, obviously, is that these cataracts in these patients have not resolved on their own. These cataracts are still there.

And the absence of the ability to perform cataract surgery for the last 6 weeks has really just resulted in a backlog of these cases that will need to be performed. I would then expect, I think we would all expect that as that backlog gets worked through, so similarly, would the utilization of OMIDRIA.

So as I said, we are expecting a ramp-up and potentially numbers that surpass historical levels both clearly in cataract surgery and then as a result of that in the utilization of OMIDRIA.

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Stephen Gilbertpaul Brozak, WBB Securities, LLC, Research Division - Senior Equity Analyst [4]

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And just following up on OMIDRIA, obviously, because it's obviously where your revenue source is for right now. With these procedures, I'd like to know what you're getting feedback on because it's not like the procedures were done by someone else who are not using OMIDRIA.

What kind of feedback are you getting from the clinicians? Because obviously, this is something that they need to return to just as desperately as the patient. So what can you tell us there.

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Gregory A. Demopulos, Omeros Corporation - Co-Founder, Chairman, CEO & President [5]

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Yes. As I said, I think that the surgeons are expecting that they're going to have to work and are, frankly, looking forward to working longer hours in the OR, more days in the OR to increase their weekly surgical volumes. This has hurt. COVID-19 has hurt small businesses. And when you think about surgical practices, largely, those are small businesses. And that backlog needs to be addressed. And those surgical cases need to be done.

And correspondingly, surgical revenues need to be accessed.

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Stephen Gilbertpaul Brozak, WBB Securities, LLC, Research Division - Senior Equity Analyst [6]

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Okay. Again, thank you for that color because obviously these are dislocated times, so as much as we can draw into it for modeling purposes, it's greatly appreciated. On narsoplimab, you basically talked about the progress you've made this quarter in terms of regulatory. What -- given the disruptions that everyone has seen and the fact that this is one of those situations where, in your particular case, you've been methodically preparing your submission, what can you tell us about how the COVID has affected your submission and specifically, how you've been able to do anything as far as workarounds or anything else as far as that kind of color? And one follow-up after that.

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Gregory A. Demopulos, Omeros Corporation - Co-Founder, Chairman, CEO & President [7]

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Well, remember that we were fortunate in that we had completed the clinical trial prior to the outbreak of COVID-19. So COVID-19 really had no effect on our clinical trial. Similarly, we had announced last quarter that we had manufactured drug process -- our drug substance lots and process validation launch ahead of schedule.

And by doing that, it turns out, we also precluded the effect of COVID-19 on that manufacturing and similarly on our drug product. So all of that looks great. We continue to push forward. And we're quite pleased with the progress we're making. As I said, a lot of the company has been working remotely, but working very efficiently, very productively remotely. And we remain focused on getting the BLA completed next quarter.

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Stephen Gilbertpaul Brozak, WBB Securities, LLC, Research Division - Senior Equity Analyst [8]

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Okay. And last and I'll hop back in the queue.

On the -- on -- just to go back on the manufacturing, you now are in a position for your first indication to be able to -- whenever you -- whenever you do get facility in approval and launch, you're able to address that requirement almost instantaneously, given the fact that you have done manufacturing, and you're now in a fill/finish process so that you can deal with and go out there and administer to patients whenever you do get approval.

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Gregory A. Demopulos, Omeros Corporation - Co-Founder, Chairman, CEO & President [9]

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Yes. The manufacturing that we did, the process validation lots can be used commercially.

And so we have our commercial supply ready for launch, that is ready to go. So yes, I think, in short.

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Operator [10]

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Your next question comes from the line of Brandon Folkes from Cantor Fitzgerald.

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Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [11]

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Congratulations on the progress in the quarter. Greg, can you maybe talk about whether you are seeing narsoplimab being studied for coronavirus in any way, just given the paper coming out of China on the MASP-2 pathway? And then secondly, can you just elaborate a bit more on your levers you have for financing around as we move forward on narsoplimab? Any update in terms of whether you think the NOPAIN Act will come through, just given where legislative priorities have been shifted recently?

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Gregory A. Demopulos, Omeros Corporation - Co-Founder, Chairman, CEO & President [12]

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Okay. Thanks. Brandon, I think I want to make sure -- can you repeat the first question for me? Because it was a little muffled, so I just want to make sure I heard it.

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Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [13]

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Okay. Can you confirm whether narsoplimab or any of your products are being studied for the potential use in coronavirus?

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Gregory A. Demopulos, Omeros Corporation - Co-Founder, Chairman, CEO & President [14]

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Okay. Understood. Understood.

Look, I'll answer it this way. We're aware of the public information linking COVID-19 and the lectin pathway, specifically MASP-2. I think those data are publicly available. Those are clear to us. In fact, we had identified the connection between COVID-19, the lectin pathway and specifically MASP-2 prior to it being made publicly available. So I hope that answers your first question. Your second question, I think, was directed to OMIDRIA and what we think the likelihood of the NOPAIN Act being passed into law. Is that correct?

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Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [15]

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That is correct, Greg.

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Gregory A. Demopulos, Omeros Corporation - Co-Founder, Chairman, CEO & President [16]

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Yes. Yes. Look, it's interesting. I think that a lot of individuals might assume that all of the oxygen in Washington, D.C. is sort of sucked out of the room by COVID-19. And that's in large part a true statement. What is important there to understand, however, is that the number of vehicles moving through Congress has actually increased substantially with COVID-19.

And for a provision or bill like the NOPAIN Act, one of the most important components in getting that successfully through, as I understand the group that's leading that, which is Voices for Non-Opioid Choices is that you have vehicles. I mean, you have to have a vehicle to which to attach the provision. And given the increasing number of vehicles, I think, frankly, the likelihood of seeing that bill passed increases with COVID-19.

I think that there is -- as I said earlier, there is significant support and importantly, bipartisan support -- bipartisan support in both Chambers of Congress, in the House and the Senate and on the Committees of Jurisdiction. And in the House, those Committees of Jurisdiction would be Energy and Commerce. And Ways and Means in the Senate, it's the Finance Committee. So when you look at the support that you are seeing for this bill out of both chambers, you do see key members and leadership of those specific committees. And so I think all of that bodes well.

Again, no one can guarantee what's going to happen. But clearly, when you look at the effects of COVID-19 on psychological issues in general and addiction specifically, you see kind of horrendous results or impact on those psychological disorders and again on addiction.

And I think that's recognized. So I think we're well positioned. I think the study that was just done that we did with IBM Watson on, what, 219,000 patients, I think makes it kind of abundantly clear that not only does OMIDRIA reduce the need for intraoperative opioids, but clearly with statistical significance and clinically meaningfully reduces the need for postoperative opioids. So I think we're well positioned. I think the bill certainly is deserving, and I believe the groups that are really pushing that have positioned it well, and we're optimistic.

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Operator [17]

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I am showing no further questions at this time. I would now like to turn the conference back to Dr. Demopulos for closing remarks.

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Gregory A. Demopulos, Omeros Corporation - Co-Founder, Chairman, CEO & President [18]

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Thank you, operator, and thank you, again, everyone, for taking the time to listen in. We're pleased with our progress across our programs, and I personally am particularly proud of what our team has accomplished given the unprecedented global challenges posed by COVID-19. Again, we wish you and your families good health. And all of us at Omeros appreciate your continued support. Have a good afternoon.

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Operator [19]

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This concludes today's conference call. Thank you all for joining and you may now disconnect.