Omeros Corporation

Good afternoon and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in listen-only mode. After the company's remarks, we will conduct a question-and-answer session. Please be advised that this call is being recorded. At the company's request, any replay will be available on the company's website for one week from today. I'll turn over the call 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 risk factors section in the company's quarterly report on Form 10-Q, which was filed today with the SEC. and the risk factor section of the company's 2020 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 Dimopoulos, OMERASIS's Chairman and CEO.

Greg Dimopoulos Thank you, Jennifer, and good afternoon, everyone. We appreciate you joining us for today's call. Our agenda begins with a corporate update. As part of that, we'll be joined by Nadia Dak, our Chief Commercial Officer. Mike Jacobson, our chief accounting officer, will then provide an overview of our first quarter financial results. We reserve time for questions following the prepared comments. We'll start today's call with an update on narsoplumab. Narsoplumab is our fully human monoclonal antibody targeting MASP2, the effector enzyme of the lectin pathway of complement. Our biologics license application, or BLA, for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TATMA, was accepted by FDA for priority review. The PDUFA date is July 17th. As we recently shared, a new ICD-10 diagnosis code for TATMA and two new ICD-10 procedural codes for the administration of narsoplumab have been approved. The ICD-10 diagnosis code awarded by the Centers for Disease Control and Prevention, or CDC, will be effective October 1, 2021, consistent with CDC's annual schedule. This code will allow physicians and others to more accurately code, track, and bill for TATMA. The diagnosis code should also provide a competitive benefit to narsoplumab given that other therapies are currently used off-label to treat TATMA. This off-label use has frequently been reimbursed because without a specific TATMA diagnosis code, these off-label therapies have been coded with diagnoses for which they are approved. Now, with a diagnosis code specifically for TATMA, it should become easier for payers to track and question use of off-label therapies. We expect narsoplumab will be the first drug approved specifically for the treatment of TATMA, and if so, its use would be uniquely on label for TATMA. In addition, the Centers for Medicare and Medicaid Services, or CMS, granted two ICD-10 procedural codes that will allow providers to bill for the administration of narsoplumab. in the inpatient setting. These codes also become effective on October 1, 2021. Throughout the application process, OMEROS collaborated closely with key transplant societies and organizations including the Center for International Blood and Marrow Transplant Research, the American Society of Transplant and Cellular Therapy, the American Society of Hematology, the Pediatric Transplantation and Cellular Therapy Consortium, Be The Match National Bone Marrow Donor Program, and the TATMA Guidelines Working Group, which consists of some of the most respected transplant physicians in the U.S. and Europe. Narcoplumab is also a focus of attention at international society meetings. Selected for a podium presentation, Professor Alessandro Rambaldi of the University of Milan discussed the narsoplumab TATMA pivotal trial data in February at the annual meetings of the European Society for Blood and Marrow Transplantation. That conference also featured several other scientific presentations on narsoplumab in TATMA. For the upcoming 2021 Congress of the European Hematology Association in June, the narsoplimab TATMA pivotal trial data again were selected for a podium presentation. In addition, two manuscripts will soon be submitted, one authored by investigators of the TATMA pivotal trial, details the trial's results, and the other authored by international experts on complement as well as by leaders in adult and pediatric stem cell transplantation, elucidates the role of MASP2 in the lectin pathway in TATMA and other endothelial injury syndromes. Narsoplumab also continues to be used to treat critically ill COVID-19 patients. In prior calls and presentations, we've highlighted the pathophysiologic similarities between TATMA and COVID-19. which are both endothelial injury syndromes. We've also published results from the first cohort of narsoplimab-treated COVID-19 patients in Bergamo, Italy, all of whom recovered, survived, and showed no clinical or laboratory evidence of long-haul disease. Results from the second cohort of critically ill COVID-19 patients in Italy are similarly impressive. Data have been collected, and we expect that they also will be published. In addition to the severely ill COVID-19 patients we've treated under compassionate use, narsoplimab is part of the nationwide I-SPY COVID-19 trial sponsored by Quantum Leap Healthcare Collaborative. Partly funded by BARDA, the trial features an adaptive platform designed intended to increase its efficiency by minimizing the number of study patients needed and the overall trial duration. Dosing of patients with narsoplimab in the trial began in early March. Work also continues at our laboratories at the University of Cambridge, the O'Meara's Cambridge Center for Complement and Inflammation Research, or OC3IR. The OC3IR is part of the Humeral Immune Correlates of COVID-19 Consortium funded by UK Research and Innovation and the British National Institute for Health Research. We expect that soon a series of manuscripts will begin coming from OC3IR directed to narsoplumab and the lectin pathway in COVID-19. The rollout of COVID-19 vaccines continues to have its challenges. Meanwhile, variants of the SARS-CoV-2 virus continue to grow in number, perhaps hasten, by selective pressure resulting from therapeutic approaches aimed at conferring passive immunity. At the same time, global 19 infections, hospitalizations and deaths continue mounting. Many experts in the field believe that the key to an effective therapeutic is targeting the endothelial injury and associated complications like thrombosis and hypercoagulation. that reportedly are present across all COVID-19 variants to date. This speaks directly to Narsoplimab, not only for acute COVID, but potentially also for debilitating aspects of long-haul disease. Discussions are ongoing with governments in the U.S. and internationally regarding funding and manufacturing support. Beyond our work in endothelial injury syndromes, namely TA, TMA, and COVID, we have two ongoing phase three programs for narsoplumab, one in IgA nephropathy and the other in atypical hemolytic uremic syndrome, or AHUS. Our phase three Artemis Igand trial has over 120 sites already activated worldwide. We're also expanding to additional geographies, including China, where IgA nephropathy is more prevalent than in other parts of the world. We expect that this expansion will further accelerate progress in the Artemis IGANT trial and allow us to wrap up enrollment and read out proteinuria data next year. To our knowledge, narsoplumab is the only drug in development for IgA nephropathy that can obtain full or regular FDA approval on proteinuria data alone. Now let's look at our first quarter financial results. As we discussed on our last call, Omidria recently was determined to qualify for separate payment by CMS when used in ambulatory surgery centers or ASCs under CMS's policy that provides separate payment for non-opioid pain management surgical drugs. Net revenues from the sale of Omidria in the first quarter were $21.1 million, a doubling over the previous quarter. Sales of Omidri have continued to grow through the first part of the current quarter and are quickly approaching revenue levels in the ASCs present before Omidri has passed through status expired on September 30th of last year. The revenues achieved in the first quarter were despite limited sales in January and part of February. caused by a delay on the part of Medicare administrative contractors, or MACs, in posting CMS's December action restoring separate payment for Omidria. This delay created uncertainty regarding reimbursement among a good number of our customers who refrained from purchasing until the MACs publicly confirmed restoration of Omidria's separate payment in late January. Our net loss for the first quarter was $35.1 million, or 57 cents per share, of which $4.1 million, or 7 cents per share, were non-cash charges. As of March 31, we had $100.5 million of cash, cash equivalents, and short-term investments. We also have a $50 million accounts receivable-based line of credit, and an additional $150 million available through an at-the-market equity program. Now that separate payment has been restored in the ASCs, we remain committed to ensuring that cataract surgery patients in hospital outpatient departments, or HOPDs, are also able to access Omidria. The Non-Opioids Prevents Addiction in the Nation Act, or the No Pain Act, would do just that. mandating separate payment for non-opioid surgical pain management drugs like Omidria when used in either ASCs or HOPDs. The No Pain Act has been reintroduced in the Senate and already lists 17 senators as co-sponsors. We expect the House companion to the Senate bill to be introduced within the next several weeks by its lead sponsors. Democrat Representatives Custer and Sewell, and Republican Representatives McKinley and Fitzpatrick. The No Pain Act has strong bipartisan support among congressional members and leadership, as well as from medical societies, including the American Medical Association, and counts as its supporters a number of very strong patient advocacy groups. With that, I'll turn the call over to Nadia Dak, our Chief Commercial Officer, to provide an update on commercial activities for both Narsoplimab and Omidria. Nadia?