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 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 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 will turn the call over to Dr. Demopulos.

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-CoV-2. Every day first responders and healthcare 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 compliment and specifically MASP-2. Omeros exclusively controlled 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 on cellular damage broadly activate the lectin pathway of compliment by blocking MASP-2, which is the lectin pathways effector enzyme, narsoplimab inhibits the lectin pathway. We resolve the historical data collection issue that we referenced during our last earnings call and we continued 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…

Yes. Thanks Greg. As Greg noted, OMIDRIA and total revenues for the first quarter were $23.5 million, and our net loss was $29 million or $0.53 per share. This includes non-cash 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, a midyear 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 surgeries shutdown, we effectively record revenues from only one-week out of the five 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 of five drugs 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 [indiscernible]. Our field finished partner that like a 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 cell following anticipated approval in transplant TMA. The financial result of these two activities…

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

[Operator Instructions] Your first question comes from the line of Steve Brozak with WBB. Your line is now open.

Hey, good afternoon and thank you for taking the questions. 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 – 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 in, and as much color as you can give on that would be greatly appreciated? And then I've got one follow-up question on our supplement please. Thank you.

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 it, the groups are starting in a controlled way, as with all sort of re-entry 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 six weeks has really just resulted in a backlog of these cases that will need to be performed. I wouldn't then expect – I think we would all expect that as – that backlog gets worked through, so similarly with 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 a Omidria.

And just following up on Omidria, obviously because it's obviously where your revenue sources are 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 or 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?

Yes. As I said, I think that – I think that the surgeons are expecting that they're going to have to work and are frankly looking forward to working longer hours and/or more days and are 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 that backlog needs to be addressed, and those surgical cases need to be done and correspondingly surgical revenues need to be accessed.

Okay. Again, thank you for that color, because obviously this is – these are dislocated time, so as much as we can draw into it for modeling purposes, it's greatly appreciated. On narsoplimab, you – 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 work arounds or anything else as far as that kind of color? And one follow-up after that. Thank you.

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 trials. Similarly we had announced last quarter that we had manufactured drug process, our drug substance lots and process validation lots 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.

Okay. And last and I'll hop back in the queue. Thank you. On – just to go back on the manufacturing, you now are in a position for your first indication to be able to, whenever you do get a 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 the still finished process so that you can deal with and go out there and administer the patients whenever you do get approval? And thank you and I'll hop back in the queue.

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 – that is ready to go. So, yes, I think in short.

Great. Thanks again.

Thank you.

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

Hi. Thanks for taking my questions and congratulations on the progress in the quarter. And Greg, can you maybe talk about whether you are seeing [indiscernible] studied for coronavirus and any way, just given the – coming out of China and then MASP-2 pathway? And then secondly, can you just elaborate a bit more on your levers you have for financing around as you 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? Thanks again.

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

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

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 COVID19, the lectin pathway and specifically MASP-2 are 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?

That is correct, Greg.

Yes. Yes. Look, it's interesting, I think that a lot of individuals might assume that all of the oxygen in Washington DC 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-opiate 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 and 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, 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 intra-operative 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.

Great. Thank you very much. Thanks Brendan.

Thanks, Brandon.

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

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 family's good health, and all of us at Omeros appreciate your continued support. Have a good afternoon.

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