Omeros Corporation (OMER) Q1 2015 Earnings Report, Transcript and Summary

Good afternoon, and welcome to today's conference 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 1 week from today. I'll turn the call over to Mark Metcalf at 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 Risk Factors section of the company's 10-Q filed with the SEC earlier today for a discussion of these risks and uncertainties. Now I would like to turn the call over to Dr. Greg Demopulos, Chairman and CEO of Omeros.

Thank you, Mark, and good afternoon, everyone. Also with me today is Mike Jacobsen, our Chief Accounting Officer. I'll start today's call with a corporate update, after which Mike will provide an overview of our first quarter financial results. We have reserved some time for questions after the financial overview. I'd like to begin the corporate update with an overview of the recent launch of our commercial product, Omidria, the first and only FDA-approved product for intraocular administration that prevents intraoperative miosis or pupil constriction and reduces postoperative pain, providing consistent and predictable management of these problems for ophthalmic surgeons and their patients. During the first quarter, we successfully completed a controlled launch of Omidria to a small number of ophthalmic surgeons, collectively drawn from the Medicare administrative contractor regions across the U.S. The purpose of this controlled launch was to pressure test our commercial processes, including distribution and reimbursement. The controlled launch was successful, with the surgical facilities receiving product quickly and efficiently. Reimbursement was straightforward, with the facilities receiving appropriate payments from Medicare and supplemental payers. In addition to the claims submitted to Medicare Part B, a handful of claims were also submitted to Med Advantage or Medicare Part C payers, as well as to commercial carriers. And payments were received for these claims as well. The clinical feedback from the surgeons who used Omidria during the controlled launch is uniformly positive, including anecdotal, but consistent reports of how Omidria precluded the need for pupil-expanding devices and made routine what would otherwise have been stressful cases for the surgeons. In connection with this restricted and limited duration program, we reported first quarter sales revenues of $238,000. Following the controlled launch in the first part of April, we initiated the broad launch of Omidria, making product available through the specialty groups of the 3 major wholesalers in the U.S. We have hired a national head of reimbursement and regional reimbursement account managers, and the team is up and running. We continue to build a significant presence within the ophthalmic surgery community. The full-scale introduction of Omidria at the annual meeting of the American Society of Cataract and Refractive Surgery last month in San Diego was a success, with Omidria receiving a substantial amount of attention. Our speakers bureau is in force and consists of a group of the top thought leaders in cataract surgery and lens replacement. While still very early in our U.S. launch effort, the distribution efficiency, the reimbursement success and the strongly positive clinical response have carried forward from the controlled launch. Surgeons have used the product across both routine and difficult cataract cases, including intraoperative floppy iris syndrome, or IFIS, and pseudoexfoliation, as well as in conjunction with femtosecond laser, and the reported results have been uniformly positive. Consistent with the feedback during the controlled launch, cases in which surgeons expected to need pupil-expanding devices were usually completed without them. While these reports are anecdotal, their frequency and consistency across numerous surgeons are noteworthy. As many of you know, we've received transitional pass-through reimbursement status for Omidria from the Center for Medicare and Medicaid services, or CMS. Established by Congress and administered by CMS, pass-through status is designed to promote and foster innovation. Budget neutral with respect to the health care system, pass-through status provides reimbursement for Omidria outside of the bundled payment for cataract surgery and lens replacement. We expect pass-through for Omidria to remain in effect through December 31, 2017, near which time CMS will evaluate the product's utilization and revisit its reimbursement status. CMS has set the reimbursement rate for a single-use file of Omidria at the product's wholesale acquisition cost, or WAC, of $465 plus 6%. This reimbursement rate will be in effect under Medicare Part B until September 30, 2015. After which time, the rate will adjust to average selling price, or ASP, plus 6%. Surgical facilities are now routinely receiving reimbursement for their Medicare Part B patients. In addition, surgical facilities have also received payments for claims submitted to Medicare Part C or Med Advantage and through commercial payers. With respect to our European regulatory efforts for Omidria, in April, we attended an oral explanation meeting with Europe's Committee for Medicinal Products for Human Use, or CHMP. As previously stated publicly, we expect to receive an opinion this quarter from the CHMP on our Marketing Authorization Application for Omidria. Our European strategy remains to partner for the product's marketing and distribution. Turning to our pipeline programs, let's first focus on our MASP program. Our MASP-2 antibody, OMS721, targets the lectin pathway of the complement system, a key part of the immune response. Our current Phase II clinical program is evaluating OMS721 in patients with complement mediated thrombotic microangiopathies, or TMAs, a family of rare debilitating and life-threatening disorders characterized by excessive thrombi or clots in the microcirculation of the body's organs, most commonly the kidney and brain. Our Phase II trial specifically is assessing OMS721 in atypical hemolytic uremic syndrome, or aHUS, thrombotic thrombocytopenic purpura, or TTP, and human stem cell transplant related TMAs. We are pleased by the progress of the Phase II trial, as well as by the growing enthusiasm for and confidence in OMS721 by the participating physician investigators. We've previously announced that the low-dose cohort of study patients in the Phase II trial demonstrated improvements across TMA disease markers, and that the investigators treating these patients at different sites considered the improvements to be both treatment-related and clinically meaningful. Based on these clinical improvements, an investigator in the low-dose cohort requested continued treatment for his aHUS patients. We are pleased to report that the investigator has now received both approval from his governing European regulatory authorities and a sufficient supply of OMS721 from Omeros, allowing him to continue treating his patients. We also recently completed dosing in the mid-cohort of the same Phase II trial. Patients in this second cohort demonstrated improvements across the same markers of disease activity as did the low-dose patients. And as occurred in the first cohort, an investigator in the mid-dose cohort has requested extended access to OMS721 for compassionate use, so that he can continue to treat his patient. We are working with this physician as we plan to work with others to provide OMS721 to aHUS and other TMA patients who may benefit from treatment with our drug. The high dose or third cohort in the OMS721 Phase II TMA clinical trial is now open for enrollment. We expect to release detailed data from the dose-ranging stage of this trial later this year. For OMS824, our PDE10 inhibitor in development for the treatment of cognitive disorders, including Huntington's disease and schizophrenia, clinical trial enrollment, as previously reported, is currently suspended in connection with an observation in a single nonclinical rat study. We submitted the package of nonclinical materials requested by the FDA earlier this month, seeking to reinitiate the OMS824 programs in the U.S. We look forward to reactivating enrollment in our OMS824 Phase II clinical program in the near future. Our preclinical programs are also advancing. Our PDE7 inhibitor, OMS527, and our plasmin inhibitor, OMS616, are progressing. And we currently plan to begin clinical trials for both compounds next year. Our MASP-3 inhibitor program, OMS906, for inhibition of the complement systems alternative pathway is also making significant strides. With respect to our GPCR program, we continue to strengthen our intellectual property position and a number of specific targets are advancing through medicinal chemistry and preclinical testing, including GPR17 for remyelination, GPR101 for cachexia, GPR151 for neuropathic pain and GPR161 for triple-negative breast cancer and other types of malignancies. That concludes our corporate update. At this point, I'd like to turn the call over to Mike for a summary of our first quarter financial results.

Thanks, Greg. For the quarter ended March 31, 2015, we recorded a net loss of $18.7 million or $0.51 per share, which includes noncash expenses of $2.8 million or $0.08 per share. This compares to a net loss of $16.6 million or $0.54 per share for the same period in 2014, including noncash expenses of $2.7 million or $0.09 per share. Revenue for the first quarter of 2015 was $388,000, compared to $100,000 for the same period last year. Of the current quarter amount, $238,000 was for Omidria product revenue and $100,000 was grant revenue. As Greg discussed earlier, we conducted a controlled launch of Omidria to a small number of surgeons beginning mid-February to pressure test our commercial and reimbursement processes. And we initiated the controlled launch -- the controlled launch was a success and we initiated the broad U.S. launch in the first part of April. Operating expenses for the first quarter were $18.3 million, compared to $15.8 million 1 year ago. The increase was primarily due to sales and marketing expenses related to the U.S. commercial launch of Omidria. This increase was partially offset by reduced research and development expenses, as a result of manufacturing schedules for clinical trial drug supplies and the suspension of clinical trials related to OMS824. At March 31, 2015, the company had cash, cash equivalents and short-term investments of $70.1 million. With that, I'd like to turn the call back over to Greg.

Thanks, Mike. So I think at this point, operator, we can go ahead and open up the call to any questions.

[Operator Instructions] Our first question comes from Serge Belanger of Needham & Company.

A couple questions on the Omidria launch. I think, Greg, you had previously mentioned you had a sales force of about 20 reps already out. And then in April, with the broader launch, the additional half, the other half of the sales force, the other 20 reps entered the market. Just wanted to know if each of these sales force are addressing the same market? Are they mirroring each other? Or targeting different market segments?

Well, they're -- each is targeting a different region. So with the 40-person sales force that we have, we expect that we're able to access in excess of 80% of the Medicare Part B procedures that are performed. If you look at the volume producers, so the cataract surgeons by volume of the surgical procedures, what you find is that those same 40 reps are able to access greater than 80% of the top 50, top 100 and top 150 of those producers.

Okay. And then you mentioned the reimbursement price was set for the first 2 quarters of the launch. And then I guess in September, it would be subject to a different metric, I think the average selling price. Just wanted to know a little more about that process and I guess, what you expect, I guess, come September?

Yes, I would expect that -- and you are correct, WAC plus 6% remains in effect for the first 2 full quarters, which would take us through Q2 and Q3 of 2015. Moving into Q4 or at the start of Q4 2015, that will switch to ASP plus 6%, or average selling price, as you said, plus 6%. We don't expect that difference to be meaningful.

Okay. And I guess, I know it's early in the launch, but what -- I guess what portion of the Omidria market do you expect to be covered by Medicare?

I'm sorry, which -- you'll have to clarify a bit what you mean by that when you say which portion do we expect to be covered by Medicare. Medicare will cover the Medicare Part B procedures. As I mentioned in my update, what we have been seeing is that Medicare Part C or Med Advantage has also been reimbursing for Omidria, as have some of the commercial carriers to which billings have been submitted. Remember, we're early in the process, but we're getting this information in as close to real time as we can get it, and so that's what I provided.

Okay. And then just a couple on the pipeline. First on OMS721, so coming out of this open-label study, do you think you'll be in position to advance to a Phase II proof of concept? Do you think you'll have the dosing -- enough dosing information to proceed to that step?

Yes, yes. Remember that the OMS721 Phase II trial is in 2 parts. The first stage of that is a dose-ranging stage, which is currently set for 3 cohorts. And as I mentioned, we are currently open to enrollment in the third highest dose cohort. The second stage of the 721 Phase II trial is one that we'll be treating patients at a selected dose. In the dose-ranging stage, it really is open to all types of patients that we are studying, meaning aHUS, TTP and stem cell transplant-related TMAs. In the second stage of the study, it is 50% open to aHUS, 50% will be enrolled, as currently written, from the TTP and stem cell transplant-related patients.

Okay. And on 824, you submitted the package of nonclinical materials. What do you expect the timelines to be there in terms of FDA response? And I guess what are the current plans to proceed forward? Can you continue enrolling in the existing study, or you'll start anew?

Well, 2 questions there. One is yes, we have submitted the materials to the FDA. We are waiting to hear back from them. We will keep you advised as we get any further information from the FDA. With respect to once cleared, as we expect and hope that we will be, we will then move ahead with work in the Huntington's program initially. And consequently assess what we plan to do or want to do on the schizophrenia program.

Our next question comes from Steve Brozak of WBB.

Obviously, this is really probably the most important quarter barring obviously the approval. And I really do want to go back over this, because knowing physicians pretty well, they obviously do care about their patients, but they obviously do care about making sure they don't lose money. And the reimbursement has to be critical. What are you seeing as far as doctors using Omidria? And what are you seeing in terms of their feedback and the specifics to how you're assisting them and facilitating them? And I've got one follow-up question after that.

Okay. Yes, I think it's a good questions, Steve. I think it's astute. Look, the most important thing, initially, is what is the physician response to the product? Are they seeing the product as a nice to have or as something that has a really meaningful impact on their practice and on the ease of doing those procedures? And again, while anecdotal only, and I want to underscore that because we are early in the launch, I think that it is, as I said, sort of uniformly falling into the latter, meaning that the docs are really quite impressed and pleased with the performance of the drug product. The second sort of hurdle there is the one that you're also identifying, which is will I be reimbursed for this product? So one might imagine that physicians and facilities take a somewhat cautious or stepwise approach to that. You don't want to put in 1,000-unit orders for a product that you may end up having to eat. So the idea here is, which would make sense, is that to test drive that reimbursement process. Reimbursement has been really quite successful across the country. So we're very pleased with that component as well. Does that answer your question?

Yes, actually. And it just does -- you just opened up a question with that, and I'll hop on after you answer it. Being conservative, obviously, physicians first do no harm. How are physicians looking at this, considering the liability that they might have, given you're talking about a compounded versus an FDA regulated manufactured product versus the compounded product that doesn't have the same amount of controls over it as what you're looking at. So if you could answer that. And what do you think about what the liabilities that we're talking about might be? And I'll hop back in the queue.

Interesting question, Steve. Look, I can't speak for specific physician and their thoughts on that topic. So I think probably, the safest thing for me to do is provide my own. I think that prior to Omidria, there was no FDA-approved product available that could address the miosis problem during surgery. There now is. I think that, that likely has a meaningful, potential impact on overall questions of, "Gee. What should we, as docs, be using?" We'll have to see how all that plays out. Again, I think that the FDA's position on compounding versus FDA-approved products is clear. I don't think there's much, frankly, that I can add to that or really would feel comfortable adding to that. I think the FDA has made their position on that quite clear.

No, you just -- I mean, look, you just answered in volumes, obviously. And it's one of those things where I'm really looking forward to seeing the physician adoption, because obviously, when they start to use it and they start to get paid, then that will be as clear-cut as you can get.

Our next question comes from Ram Selvaraju of MLV & Co.

Very quickly, could you give us an idea of what you expect the time lag to potentially be between receiving European approval of Omidria and inking a partnership in order to commercialize the drug in that territory? Secondly, could you give us an idea of how we should anticipate R&D expenses to evolve going forward? It looked as though they were markedly lower in the current quarter versus the last quarter of last year, and I wanted to get a better understanding of what we should view as a baseline level from which to build our assumptions on that front? And then with respect to 721, wanted to get a sense of whether you anticipate seeing significantly more human clinical data from the European compassion access program by the end of this year? Or with what time frame we should expect to see significantly more efficacy information on that product coming from the compassion use program?

Yes, I think your first question, which was the partnering question tied to what we hope and expect will be a European approval, we don't, Ram, I'm sorry, provide projected dates around partnering, and we don't speak in detail around partnering discussions. So on that one, I'm going to have to tell you that we'll just keep you informed. The first step, of course, that we're looking for is the European approval. As I mentioned earlier, we do expect to receive the CHMP opinion this quarter, and we'll go from there and keep everyone advised. With respect to your second question, which, if I remember correctly, was around OpEx, operating expenses and R&D expenses, in particular, going forward, I know that last quarter we put out a number that was I think a bit large to some. And what I think might have been missed in that call was that those R&D expenses were really driven by, and assuming, that all programs within the company were operating at full throttle. Now what you've seen in this quarter is that with OMS824, on clinical hold pending the response from the FDA, those R&D expenses decreased a little bit. You can also look across all of our programs, and what you see there are dials that we can dial up or down around each of the programs to adjust our R&D spend, so that we can adjust those expenses really based on revenues from Omidria. So we need to see and watch, and we are optimistic about how those revenues will turn out with Omidria. But what you see here is that based on revenue, based on what's coming in the door, we can certainly adjust what we spend on the R&D side. So I think that's what you've seen there, and I think that's actually a very positive thing for Omeros, which allows us to kind of fine tune how we run our business. And your third question was around OMS721, and when we would be releasing additional data from the Phase II program. Look, we are open to enrollment in the third cohort now. I would expect that certainly, this year, we're putting out additional data on that program, additional efficacy and safety data on that program. Is that helpful, Ram?

Definitely. Just to clarify though, when you talk about additional data for 721 from your Phase II program, how does this dovetail with the data that might come out of Europe? And how many more patients do you think might potentially be treated with 721, assuming that efforts currently underway to get the approvals necessary to make 721 available in the second European country are successful?

Well, I think, certainly, there will be more patients that can potentially be treated through those programs than would otherwise be able to access our drug, OMS721. The numbers, I'm, probably at this point, Ram, not comfortable predicting or projecting, I think that if you look at the enrollment rate for the second cohort, that was actually pretty quick. And I don't expect really anything too different for the third cohort and continuing to move forward. Although again, these are simply my musings more than anything else. And I think what we have to do is just see as the data roll in, we will be sharing those. As with respect the your specific question, certainly, I think there will be more patients that we will be including in the program, which is, again, very good for us from just even purely a safety perspective, a safety population. So I think that all of that is favorable for us.

Our next question comes from Yatin Suneja of Cowen and Company.

The first one is on Omidria. Could you help us understand how physicians are deciding in which patient to use Omidria? Is there an algorithm or diagnostic algorithm that you have laid out? And then where do you think that primarily the use will come from? Will it only be high risk or everybody will use it? Or it will be used in mostly all the patients?

Well, I think, first, Yatin, how are you? I think that the -- in answer to your first question, really, the criterion that's being used initially is, is this a Medicare Part B patient? So that reimbursement should be sort of right down the fairway. As I mentioned in our update, a number of physicians, a number of surgeons and facilities have been submitting to Medicare Part C or Med Advantage, as well as to commercial carriers. And again, anecdotally, have been getting reimbursed. So I think that utilization will continue to expand across multiple different types of carriers. I think with respect to your specific question about, "Gee, is this really more for difficult cases or routine cases?" Miosis is a difficult problem to predict. The data are very clear about that in the literature. So again, I'm not an ophthalmologist but I am a surgeon, so I feel I can speak to this with some understanding. I think that what we're hearing from the surgeons is that they would like to use this product, those that are using it would really like to use it in all of their cases. Again, the discriminator there is, are they getting reimbursed or not? Because this is -- this would be something that they would not like to have to just absorb at this point, while they're still assessing the usefulness and the benefits of the product to them and to their patients. So I think that's really the driver at this point.

Our next question comes from Robert LeBoyer of Maxim Group.

Just a question for you on the expectations for the product for the full year, and if there are any updates to guidance that you can give for revenues or utilization in any particular segments or any anything at all like that?

As much as I'd like to, Rob, I think that right now, I think, clearly, what we need to say is we're collecting information. We actually don't expect to be providing guidance on sales for the first year of sales. I think we're taking a conservative approach. We -- I think, again, I'll step back and look at this in sort of the big picture perspective, which is, are the surgeons feeling that and finding, not just feeling, but actually finding, observing that this product has a significant place in their procedure. Today, again, anecdotal only from the early controlled launch and from the first days and weeks of the broad launch, but I think the answer to that, based on, again, those limited data, is a resounding yes. That's important. The second component is, are they getting reimbursed? I think the answer to that again is yes. So I think that we'll just wait to see how all of this goes. I know our sales team is working hard. Our reimbursement team, which is now up and running, will also be working hard, working with facilities to answer any questions, help navigate the reimbursement landscape. But it's -- I think, as I said, we're pleased with where we stand right now.

Our next question comes from Liana Moussatos of Wedbush Securities.

Are we going to be able to track Omidria sales on IMS or Symphony Health?

You're not. This isn't a prescription. This is not a prescription product. I just wanted to make sure that my isn't didn't get interpreted as an is. This is not a product for which prescriptions are written. So IMS will not be helpful. We will have to report on a quarterly basis the sales. I know that's not what you were hoping to hear, Liana, but that's the reality.

Our next question comes from Chip Saye of AWH Capital.

My first question is, you have the only FDA-approved product in Omidria. And at the same time, you've spoken to this, the FDA seems to be cracking down and going after some compounders and shutting them down. When I look on the website at FDA, there's 50 or so compounders that have been approved in the last year. How does that approval, FDA approval of those compounders, how does that impact your competitive advantage?

Frankly, I don't think it has a meaningful effect there. Remember, that our product is broadly protected from an intellectual property position. Second, those compounded products, while if you're talking about 503, 503B, compounding pharmacies or outsourcing facilities, and those are ones that are authorized by the FDA to sell in bulk. Remember, that those still have to meet some GMP manufacturing requirements. But they are still not approved in the sense of an FDA approval. So the overall clinical efficacy and safety testing are just not performed on those products as they are the very rigorous standards that are set for FDA-approved products. So the short answer to that, Chip, is I don't think it changes anything. We have a broad IP position and we are FDA-approved, which means we actually meet all of those efficacy and safety standards required by multiple sets of clinical trials to get that FDA approval. These 503B compounded products, while allowed to sell in bulk, don't have those same requirements.

Okay. My second question is Leiter's, for example, is one of those compounders that when I speak to my local ophthalmologist, that's who he gets some product from. As I understand, they sell a combination of phenylephrine, which addresses the dilation, and then lidocaine, which is -- addresses the numbing inter-operatively. How does the Omidria compete with this product, given that Omidria, I don't think has a numbing agent, since the ketorolac is for pain?

Yes, great question. Let's take a step back and a combination of phenylephrine and lidocaine. Remember that phenylephrine is a dilating agent only. What is providing the prevention of miosis or constriction in the case of Omidria is not the phenylephrine, it's the ketorolac. It's the nonselective COX-1, COX-2 Inhibitor that is blocking the prostaglandin production and the generation of COX-1 and COX-2. That's important, because what causes the pupil to come down during surgery is prostaglandins. Prostaglandins acting on the iris sphincter muscle, which causes it to contract. So a combination of phenylephrine and lidocaine is not going to get you there. It's Omidria, the phenylephrine and the ketorolac that gets you there, and I will cite for you data from our Phase IIb clinical trial. There remember that as part of this rigorous FDA approval process, we had to run a full factorial study that FDA requires so that you can demonstrate that each agent included in the final product actually contributes to the claimed effect. And so what we did there was run a 4-armed full factorial study, Omidria versus phenylephrine versus ketorolac versus vehicle control. And what we saw was that the vehicle -- and what we measured there just for those who don't quite recall the study -- what we measured were the percentage of patients who any time during surgery experienced a pupil diameter of less than 6 millimeters. That's an important number. It is one that Dr. Wiley Chambers at the FDA specifically asked us to address, because the literature is replete with data around the increased, really, the multiple, so meaning, manyfold increased risk of complications when pupil diameters fall below 6 millimeters. So when we looked at those patients during the Phase II trial who had pupil diameters of less than 6 millimeters across those 4 arms, what we found was in the vehicle group, 46%; in the ketorolac group, 35%; in the phenylephrine group, 22%; and in the Omidria group, 6%. Now remember also that all of those patients in that study, just like all of the patients in our Phase III clinical program, received standard preoperative topical mydriatic agents, so pupil-dilating agents. So all of the data that I just gave you are on top of all of the patients in the studies receiving those preoperative topical pupil dilating agents. And I'll run through those numbers again for you: vehicle, 46%; ketorolac, 35%; phenylephrine, 22%; Omidria, 6%. So there's nearly a fourfold difference between Omidria and phenylephrine. Well, what is causing that difference? Well, clearly, it's the ketorolac. So I think that I'll stop there and see if that pretty much answered your question.

Okay, I'll just submit I was at the show in San Diego for a day where I met you, and that really wasn't made clear. I mean, I listened to a presentation, and I was under the impression that the ketorolac was the NSAID for pain.

No, actually the other thing that we have seen and in our data, ketorolac certainly reduced pain. And it not only reduced pain, it reduced the incidence of moderate to severe pain, which was a visual analog scale score of 40 or greater, which is similar to sort of a hip -- your pain that you get from a total hip replacement. And we all like to think that cataract surgery is relatively painless. Yet, 14% of all patients, even though they received preoperative anesthetic agents, including lidocaine or tetracaine, 14% of them had VAS pain scores greater than 40. Only half of that in the Omidria group. When we looked at those patients postoperatively who had pain scores of 0 at all time points measured in the early postoperative period, so out to 12 hours post-op, and they had to have a VAS of 0 at all of those time points to be considered pain free. The Omidria group, 50% more than the control. And then when you looked at the amount of pain medication taken, even though all the pain scores were lower, the Omidria group also used 40% less pain medication. So that's pretty odd that you would see. Normally, you don't even run a pain study that way. You hold 1 of the 2 variables constant, meaning you hold the amount of pain medication constant, and you measure VAS pain scores. Or you hold the VAS pain score level constant and measure the amount of pain medication. We did not do that here. And what we found was lower pain scores and lower pain med usage. So I think it clearly does what you're suggesting, but I'm sorry that somehow at ASCRS, Chip, that point wasn't clearly brought out about the miosis. I can tell you that working with our speaker bureau, all of these thought leaders get that point very well, actually, are very focused on that point. And I think it will be clearly there in any subsequent presentation that you see.

Okay. One last question, if you don't mind. What are doctors doing now for pain? Because you mentioned that pain may be an issue that's -- is pain an issue that's not currently being addressed?

You know I think -- look, I think that patients used postoperative pain med. I think that -- and I can say this being a surgeon, so I am not trying to rap other surgeons. But I will say that surgeons, we all like to think that our patients don't really have postoperative pain. And frankly, that all pain ultimately resolves. When you are the patient, you have a very different perspective on that situation. And in the setting of ophthalmic surgery, specifically cataract surgery, where the outcome is expected to be perfect -- remember that there are 3.9 cataract and lens replacement procedures -- 3.9 million cataract and lens replacement procedures performed in the U.S. annually. Those are very common procedures, the outcomes are expected to be perfect. A large part of the patient experience is the postoperative pain. And our key opinion leaders, our thought leaders talk to us about how they can send a patient out with 20/20 vision following cataract surgery. And if that patient has postoperative pain when they come back, what they're hearing about is not the 20/20 vision but the postoperative pain. Yet if they send the patient out postoperatively with 20/40 vision and no postoperative pain, the patient comes back and is very happy. So I speak -- I think that speaks volumes to the importance of pain to the overall patient experience. And I think that probably answers your question.

Just one quick follow-up. On the whole if you ask ophthalmologist, "Is pain an issue now in cataract surgery?" And is it a yes or a no?

I think, Chip -- yes, I think, Chip, what you need to do is it's depending on which cataract surgeons you're talking with. You're asking me to make a blanket statement and in this kind of -- to that kind of a question. I just don't think there is one. I think that if you ask -- let me rephrase the question. Is the patient experience important to the cataract surgeon and to his or her patient? I think 100% or nearly 100% of cataract surgeons will answer that question with a, "Certainly, it is." So I think that may be the question that you might want to be asking. Is that helpful?

Our next question comes from George Zavoico of JonesTrading.

I have a couple of quick questions. Regarding the transition from the controlled launch to the broad launch and from 20 to 40 reps, before the broad launch, were the 20 reps slated to start for the broad launch? They have time before the April start time to actually meet their potential customers and to prime them for when they're actually able to provide product? Or is this going to be a little bit of a delay in getting the reps in front of the docs?

I think we're conflating a couple of things here. One is that the controlled launch began in mid-February. It ran for several weeks. And then we moved in April to the broad launch. So that is in the first part of April. So that's the temporal relationship between those 2. With respect to the reps, we had our 40 sales reps in place as of early January. So this is not -- the controlled launch was not run with 20, and now we're running the broad launch with 40. The controlled launch is really not referring to the reps. It's referring to the facilities and the number of docs, the number of surgeons that were included in that controlled launch. This was simply our way of really, as I think Mike and I have said, pressure testing our processes to get the product to the facilities, and whether reimbursement was running smoothly. What we didn't want was to initiate a broad launch and find that we had either problems in distribution or problems in reimbursement that had not yet been addressed. So that was the reason, and that's why it was done in a very controlled way, with a small number of facilities and surgeons drawn from the Medicare administrative contractor regions across the U.S. We wanted to make sure that we were touching those max [ph], so that they were familiar with the product and we could make sure that they would appropriately handle and reimburse the product as expected by CMS.

So for the customers not in the controlled launch, their first opportunity for the reps to detail them came in April?

Well, their first opportunity to purchase the product came in the first part of April. Those relationships and communications with the reps have been in place for a while.

Okay. That was what I wanted to know. That's important. So there's no -- that lead time to build a relationship, that's already over and done with. And so the purchasing could happen almost right away after when you open it up in April. Next question, regarding 721 and the compassionate use in Europe, those 2 physicians, were those both aHUS, if you can answer that?

I think I can. And I don't think there's a problem in any way we're webcast, so yes, they were both aHUS patients.

Okay. And then you mentioned really good feedback from the physicians who were using it. Have you commented at all or can you comment at all about any AEs that were noted?

Other than what we put out in the first cohort, where there was a patient who had an inflammatory condition years previously, who subsequently developed that inflammatory condition while running the course of Omidria, I can tell you that the latest result is that there was no infection. So that's actually very good news. Other than that, we've released no other AEs associated with that product on 721.

Okay. And as long as we're on the complement pathway, does the new product -- or the new compound for the alternative pathway, do you see that as going for separate indications? Any overlap between the alternative in lectin pathway in terms of where you might go with it?

I think the answer to that is yes. There are separate indications for both the lectin pathway and the alternative pathway. We're very excited as well about the OMS906 program. We believe that MASP-3 is an important component, is actually the activator of the alternative pathway. And we believe we've created a strong and growingly strong intellectual property position around that. Could there be indications where you would want to inhibit both the lectin and the alternative pathway? Yes, there are. Are we looking at those? Certainly, yes, and our planning strategies for how to do that.

Cool, I'll look forward to more news on that for sure. So next question about...

Yeah. It's exciting.

Yes. About post-marketing studies with Omidria, I mean, there's a lot of obvious benefits that -- well, I suppose that you've made obvious, in your educational material to the docs. Now that Omidria is available to the docs, are you actually performing any more rigorous post marketing surveys, just to quantitate the anecdotal responses that you're getting back? Does it...

We actually have a number of studies that our medical affairs group is assessing currently. And I expect that some number of those, we will be running. For example, in connection with a question the came earlier around pain and Omidria, certainly, one of those studies that we're considering is to look specifically at pain during surgery with Omidria versus other treatments. But these are all things that our med affairs group has a handle on. They are assessing all of the proposed protocols that come into us from our thought leaders and from others. They've got a lot of work to do there. There's a lot to go through. But we'll likely be proceeding with some number of those in the coming months and years.

And that includes the pharmacoeconomics, I would presume?

I'm sorry, can you repeat that, George? You're sounding a little faint.

Sorry, that would include the pharmacoeconomics as well?

Sure, we're keenly aware of the pharmacoeconomic points around the product and believe that we can make very solid, solid cases for that.

Okay, and then one last quick question, hopefully. Regarding your commercial reimbursement that you've seen some of the physicians obtain. Is that an arrangement between the physician and the provider? Or have you had any discussions with commercial providers to provide reimbursement?

Well, with respect to the commercial payers, clearly, our reimbursement team is going to be reaching out to commercial payers, to Med Advantage payers, to assist physicians and providers in obtaining reimbursement for the product with those carriers. And I think we'll just see how all of that plays out. Again, we're optimistic that those carriers will see the value in the product to patients. And ultimately, I think despite what is rumored to be the case, I think that payers truly do want to do what is in the best interest of the patients. And I think that it's very clear that Omidria, at least based on the data we've generated as well as the data being -- and the experience being generated by the thought leaders and others now using the product across the country, that Omidria is pretty clearly a good thing for patients.

Our next question comes from David Lundquist of UBS.

The focus has understandably been around Omidria, but I'd like to shine the light on a couple of the other parts of your platform just quickly. If you could comment around your PharmacoSurgery products that are focused on knee surgery and urology indications. I know that, that may not be a near-term focus, but if I have the right impression there might be a revenue opportunity for those. So curious how that would look. And the second question is around your intellectual property development on your GPCR program, and obviously, licensing opportunities probably follow those developments. So any comments around those would be great.

Sure, let me start with the first. As we've stated publically, we are exploring ways and avenues by which we can commercialize OMS103, which is our arthroscopic product, and OMS201, which is our urologic product. You know that both of those products have been through clinical trials, 103 through successful Phase IIs, and missed in Phase III. But I think the impression certainly of the orthopedic surgeons, of the arthroscopic sports medicine surgeons is that the product works and has an important place in that it inhibits inflammation at the time of surgery. And what we're learning is orthopedic surgeons -- or have learned over the recent decade is that inflammation is detrimental to the long-term health of the joint. So I think they're excited about the product, and we're exploring the opportunities available to us. And we may in fact avail ourselves of one of those opportunities to commercialize the 103 product quickly. With respect to OMS201, that's been through a Phase I, II study. We don't have as much data on that program or in that product as we do on the 103. But certainly, when you look at the composition and you think about the pharmacology, the utilization and the applications or indications for that product, become again pretty clear to urologists. So we're exploring a similar commercialization path for OMS201 at that -- at this time. Your second question, if you would remind me? Oh, the GPCR. No, I've got it, I remember, Deke. You asked about GPCR's VIP. Yes. Look, we continue to advance the intellectual property front for our GPCR program. And I think, again, I remain confident and optimistic that we'll have success there. I think with respect to partnering, which you were asking, I think you are asking about licensing, again, I'll have to repeat that same answer, which is we really don't provide updates on partnering discussions. When we announce the partnership is when we will make all of that public.

We have a follow-up from Ram Selvaraju of MLV & Co.

Two very quick things. The noncash compensation, I believe you reported $2.7 million for the quarter. Can we expect that to remain pretty much the same going forward or no?

For 2015, yes, I expect that, that will pretty much stay the same.

Okay. And the second question was, did you mention when the second antibody targeting the complement pathway would likely -- sorry, the complement-related pathway, I should say, would likely enter the clinic?

Have not. We've not made a statement about that. We are pushing that program ahead with a lot of vigor. We're excited about that program, as we are about the 721 program. Certainly, what's coming out of the 721 program is very encouraging to us. I think, as I said, it is encouraging to the participating physician investigators. And clearly, by the request for compassionate use, there's increasing confidence in the product as well. So I think we're excited by that. And certainly excited as well with the alternative pathway inhibitor, the MASP-3 inhibitor.

Okay, and then just a very quick thing on the potential for institution of formal guidance in the future. I think we've visited this topic a couple of times before. But do you think that there would be a point in the launch when you can see a more defined sales trajectory for Omidria? When you would be comfortable providing us with more formalized guidance on what to expect there?

At this point, Ram, we said well prior to even our controlled launch, that our approach was going to be to not provide sales guidance at least for the first year of Omidria's commercial life. And if we change our position on that, we will let everyone know. I think I understand the question, and I understand your desire to know that and certainly, empathize with that. I think that the most conservative approach for the company is to say, look, we're going to, for the first year, hold off on providing any revenue estimates and projections. And let's get a handle on how the product's doing. Once we do that, then we can talk intelligently about what we're seeing as opposed to projecting things that could miss, could miss high, could miss low. And frankly, we've all seen enough of those that create problems, that we'd like to avoid it. Where there are things we can -- where we can avoid problems, I think we'd like to try to do that. So in this case, we're going to hold to our position there. If it changes, we'll certainly let you know.

Our next question comes from David Kahn [ph] of Mid South [ph].

I just had a couple of follow-ups. Most of the questions had already been asked. Initially, you had hired 20 salespeople, and then you hired an additional 20. Of the first 20 that you hired, have you had to let anyone go?

I think that I'd have to check with our group about that. But I don't know, David, that we have released any of that information. And I think that what I do know is that clearly, the bulk of the group is entirely intact. And as if I'm giving any other information, I'd be largely speculating.

Okay. And then with respect to the -- you have so many programs. And I recognize that you're still limited with respect to sales data for Omidria. So could you give me some idea how you will prioritize what your R&D spend is going to be? I mean, if you could even provide me with some type of a maybe top to bottom of priorities of the programs that you're currently working on?

I can do the latter. And I think again, remember as I've said, we have a lot of dials here that we can turn on a lot of programs that allow us to really refine and very precise...

No, and you know what? It's a very prudent to wait until you see what the revenue's going to look like before you decide to spend. So I'm in favor of that. But what I would like to get an idea is how you prioritize.

Yes, let me give you the prioritization, because I think that's your question as you asked it. And that's one certainly, that I can answer. Clearly, the priorities for the company right now are Omidria, Omidria, Omidria. And after that, I would say that clearly, OMS721, followed by OMS824. And the GPCR programs we're moving forward. The 527 and the 616 programs, we are moving forward. But I would say that if you just look at our current structure of the pipeline, I don't think there's any doubt that -- and I think you would agree that it makes abundant sense that our priority really is, as I said, kind of Omidria, Omidria, Omidria, followed by 721 and 824. And I think that, that's clearly what we're pursuing within Omeros.

I'm showing no further questions. At this time, I'd like to turn the call over to Greg Demopulos for any closing remarks.

Well, that wraps up our call then for today. Thank you very much, operator. Thanks to all who were on the call. Thanks for all who had questions. We appreciate all of you taking the time to join us today. Clearly, we're excited about the prospects for Omidria as well as for OMS721 and OMS824 and our other programs. All of us at Omeros really do appreciate your continued interest and support. And we expect that we'll be back to you over the next few months with further updates on these programs. Have a good afternoon, everyone. And again, thank you.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone, have a great evening.