Earnings Labs

Omeros Corporation (OMER)

Q3 2016 Earnings Call· Fri, Nov 11, 2016

$14.61

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Transcript

Operator

Operator

Good afternoon, and welcome to today's conference 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 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.

Jennifer Williams

Management

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 Factor section of the company's filings with the SEC 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.

Greg Demopulos

Management

Thank you, Jennifer, and good afternoon, everyone. Also with me today is Mike Jacobsen, our Chief Accounting Officer. Thanks to all of you for joining the call today. I know it's a busy time. I'll begin with a corporate update and then Mike will provide an overview of our third quarter financial results. We do have time reserved for questions following that overview. The third quarter has been a productive one for Omeros and we have a lot to discuss today. So with that let's start off with Omidria. For the sixth consecutive quarter since its commercial launch, sales of Omidria have achieved double-digit growth. Our total revenues for the third quarter were $11.3 million, all of which resulted from sales of Omidria, our FDA-approved product for cataract surgery. Omidria revenues in the third quarter increased $1.3 million or 13% over the prior quarter. This represents sell in or sales to distributors. Sell-through or unit sales to our customers were up 18% compared to the previous quarter with September showing 21% growth over June. Both July and the first half of August demonstrated the sales variability expected in the summer months. The accelerating growth that we see coming out of the summer is a positive indicator for what we expect going forward. This sell-through acceleration is driven by continuing increases in new accounts and then in vials purchased per account quarter-over-quarter. The primary reason for the difference between sell-in and sell-through for the third quarter was our focus on expanding use of Omidria within the hospital setting. This sector had previously been underrepresented in our sales as we focused initially on ambulatory surgery centers that perform cataract procedures. From a sales perspective it takes longer to achieve access and adoption in hospitals, mainly because of the need to service and…

Mike Jacobsen

Management

Thanks Greg. As Greg noted, our overall GAAP revenue for the third quarter was $11.3 million and our net loss was $14 million or $0.34 per share. Our net loss include the non-cash expenses of $3.1 million or $0.08 per share. All of our third-quarter revenue was from Omidria product sales and based on sale-in or our sales to distributors, is an increase of $1.3 million or 13% from the $10 million we achieved in the second quarter. Sell-through units or the units sold from the wholesalers to our customers, increased 18% over the second quarter. During the third quarter our net revenue per vial sold decreased slightly from the prior quarter, as a result of our increase in hospital sales, which increases our reported 340B customers and the related discounts that to come along with the 340B. The growing use of our OMIDRIAssure Program also contributed attributed to this difference as ASEs and hospitals use Omidria across a broader spectrum of cataract procedures. We expect that the net revenue per vial of Omidria will continue to be slightly as we gain additional traction in the 340B hospitals. As OMIDRIAssure usage continues to increase and as we implement other programs to drive broader usage of Omidria at both new and existing ASEs and hospitals. Our total cost and operating expenses for the third quarter were $23.3 million an increase of $2.4 million from the second quarter of this year. The increase was primarily related to additional OMS721 clinical and manufacturing activities and incremental costs associated with the par lawsuit. These increases were partially offset by a decrease in Omidria marketing cost, associated with reduced activity during the summer months. Turning to the balance sheet, as of the end of the third quarter we had $47.4 million in cash available for…

Greg Demopulos

Management

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

Operator

Operator

[Operator Instructions] And our first question comes from Tyler Van Buren of Cowen & Company. Your line is now open.

Tyler Van Buren

Analyst

Hi good evening, Greg. Thanks for taking my questions.

Greg Demopulos

Management

Hi Tyler. How are you doing?

Tyler Van Buren

Analyst

Doing well, thanks. Just a question related to the pipeline on 721, I guess first on aHUS when will we get -- well so first of all will the study be conducted in both the U.S. and Europe or just one of those territories and based upon the study design, can you help us better understand what the dosing regimen might be and also if you look at the Soliris registration trials, I believe that they enrolled patients specifically with complement mutations. So it would to understand may be any type of inclusion criteria around pathology disease in these patients?

Greg Demopulos

Management

Yes, first of all, the trials will have sites for the Phase 3 program both in the U.S. and ex-U.S., that includes Europe and Asia, and potentially other regions of the U.S. as well, I'm sorry of the world as well. Your other question was with respect to dosing, we've not put out the dose, other than to say that we will be running that study, we fully expect with a subcutaneous dose for 721. With respect to the inclusion criteria, I think that was your other question, we are enrolling both Soliris naïve and Soliris treated patients. I do not expect that we are limiting them with respect to genetic mutations. In fact frankly, we would be looking for a specific genetic mutation. As you know there is a genetic mutation most prevalent in Asians frankly highest in the Japanese population about 4% of the Japanese population, which has a mutation, which does -- it's a mutation in C5, which does not allow Soliris to bind C5. So this obviously would have no impact or should have no impact on OMS721. Does that help you?

Tyler Van Buren

Analyst

Okay. Yes, that's super helpful and what are we thinking about approximate timeline to data and will we potentially see an update on the Phase 2 data that we've seen so far, prior to that?

Greg Demopulos

Management

Yes, we're not put out the timeline to completion of the study. You had mentioned the U.S. and European designs for the study, as we have made public, the Europeans guided to a 40-patient trial in total and we would be looking for something similar to that with accelerated approval in the U.S. Let us get the study beginning to enroll. As I said we plan to be open for enrollment in that study later this year and once we start to enroll that study and see how our sites are doing, we have a large number of sites lined up. We'll be able to speak more credibly I think about timelines.

Tyler Van Buren

Analyst

Okay. That's great. And with respect to the kidney program, specifically in the IGA nephropathy was great to see the reductions on those endpoints in those patients with obviously very severe disease, but curious with respect to the study, maybe you could just help us understand the lead-in period for the study with respect to steroid use, were they on stable flat levels of steroids for the month leading up to the study or was that kind of open.

Greg Demopulos

Management

Yes, they were on flat levels of -- they were on stable levels or stable dosing of steroids for a number of months prior to initiation of 721. So in addition to the improvements that we saw in the endpoints, I think we also mentioned in the press release that we had reduced the levels of steroids that the patients were taking.

Tyler Van Buren

Analyst

That's great and lastly on R&D expenses, given all the activity, should we expect things to change for the following next few years and particularly next year?

Greg Demopulos

Management

Yes again as Mike mentioned, we do expect that the OpEx will increase. It's hard not to when we now have really five different indications that we're exploring for OMS721. But remember these are likely going to be single studies registration studies for each of those indications and that that's going to help I think manage those costs. We'll continue to make all of you aware, keep you up-to-date on what those expenses we expect will look like but I can say if you look historically, we've been able to run a pretty complex clinical trials and still keep a pretty good lid on our operating expenses. That is something that I think is ingrained here and I really don't see that changing either philosophically or practically here. So I think we'll continue to manage the expenses well.

Tyler Van Buren

Analyst

Great, thanks for taking my questions.

Greg Demopulos

Management

Thanks Tyler.

Operator

Operator

Thank you. And our next question comes from Steve Brozak of WBB Securities. Your line is now open.

Steve Brozak

Analyst

Hey good afternoon, Greg. This is obviously a very exciting time for Omeros, but I did have two questions that frankly, I'll bifurcate them, the first one is with Omidria, correct me if I'm wrong, but you'd said basically that you're running at a $55 million revenue run rate? Is that correct?

Greg Demopulos

Management

I am saying that yes, at our current annualized run rate, weekly sales and remember we're looking at weekly sales really weekly. At our current annualized sales, we're running at about a 55 million net revenue run rate and we expect that to continue to increase.

Steve Brozak

Analyst

Now going along with that, because obviously one thing that picked my curiosity was the fact that you're looking at the hospital sales and the differential between -- the differential that is hospital sales and the stickiness of that sales, can you give us as much colors as you can on that because obviously you had started talking about it, but I would like to know more about that because obviously that helps in terms of building the run rate into the future.

Greg Demopulos

Management

It's a good question Steve. Yes, we really considered and consider Q3 as in good part an investment in the future of Omidria. As I mentioned in the initial comments we had really focused on ASEs and the hospitals were in good part left underrepresented, underserved by Omidria and that's really a function of just how long it takes to get hospitals up and running. When you have the multiple layers of approval you have the P&T committees, most or all of that is really missing in and ASC are absent in an ASC so that the ASEs allow really quite rapid uptake but our focus for Q3 on our commercial team was to get after the hospitals because just as you're pointing out, there is a stickiness associated with hospitals. Once that drug is through the P&T Committee and once it's in use, that product tends to be pretty sticky within the hospital setting. You also have recurring benefit, which our residents as I think I mentioned and I think we all know and having been one I can speak firsthand about this. When you leave residency or any fellowship, you tend to do at least for several years what you were trained to do in your training program. And if you have used a specific drug and you see the benefits of that when you leave that training program you really do use the same equipment, you use the same drug that's everything that you're familiar with, you understand those benefits. And so really what this allows us to do as if were in the hospitals, every year we are seeding new customers, which are then leaving those residency programs and moving into private practice or into other academic centers carrying with them the standard of use hopefully for Omidria and it's a very effective way to grow the business and that's why we focus there and I think as we said Q2 to Q3 grew by 41% that we're very pleased with that growth. And I think I also might've said this, but perhaps too quickly, which when you look at our overall sales ASEs versus hospitals, those sales for Omidria now directly mirror or are effectively directly superimposable on that same split for cataract surgery across the country, 65% in ASEs, 35% in HOPDs or hospital outpatient departments, that's the split for cataract surgery, that is now the split for Omidria sales and I think that's that really needs to be underscored because I think that's an important point.

Steve Brozak

Analyst

No I look that obviously gives you building blocks to look at. So obviously these next quarters are going to be terribly important and obviously very, very refreshing in terms of the data. Let me switch from that part to 721, because you had mentioned something. Obviously you've got 125 shots on goal as you put it and that orphan, the one question I had in terms of the single studies because the one thing obviously people always want make sure is what are the precursor information on the single studies that you're seeing in the past for instance from in some cases competing products, what are we looking at in terms of regulatory acceptance and what are the hurdles that you're looking at and again obviously this all leads back to the cost of the studies, which you really probably don't want to tell us about, but it also leads to the acceptance of the data from the studies and how you can go forward on that and I just want to follow-up after that.

Greg Demopulos

Management

Well I think and I'm going to answer this at a high level because I think it will take a little longer than we probably have to go through each one of them but certainly we expect to qualify for expedited programs across all of those indications. We already know where we stand with aHUS. As I think we've released publicly we have already had discussions about IGA nephropathy with the FDA, we've already had discussions with the FDA also about not a poetic stem cell associated TMA and we certainly will expect to be back at some point talking with the FDA about membranous and about C3 glomerulopathy as well. So I think with respect to precedent aHUS that's pretty clear Solaris is a clear precedent there and frankly we're quite pleased with what the FDA and EMA frankly proposed relative to what the Alexion had to do for Soliris. When you also look at these other indications, remember for all of those other indications, all four of them, there is no approved treatment. So we're going to be obviously very interested in pursuing breakthrough designation, in fact we've already had discussions with the FDA about breakthrough both for IGA and for stem cell transplant related TMA. There are other products as you know that have been in development for IGA. So with respect to end point, there have been discussions, we believe that that will allow us to lever end points for OMS721. There is there is a pretty significant difference too between -- there's been a question that I've received with respect to does an IGA take a long time? Aren't those long studies? That really is a function of how the drug works and there's a specific reference to a very difficult to enroll study. What one needs to understand there is largely that that drug holds the progression of IGA stable and then waits for the control patients to move away to worsen beyond that sort of stable IGA progression or halted progression on the treatment side. That's a very different situation than what we're seeing so far with OMS721, which with 12 weeks of dosing. We're knocking down both the urine albumin and to creatinine ratios and also that the 24-hour proteinuria. So it's a very different situation, we think we'll be able to enroll these expeditiously and again across all of them we expect that we're going to be able to take advantage of an expedited approval process.

Steve Brozak

Analyst

And you actually you just let -- my last part of this question and I'll hop back in the queue, you had mentioned, you're dealing with highly sophisticated clinicians here that are laser-like focused again I'll use that word in these indications, what kind of feedback do you think you're starting to see because obviously the data that you're coming back with is different than what would be expected in the response from the regulators or as good as you could ask for. So what do you think the clinicians are seeing and obviously you've got compassionate used vehicle as well, but what are your thoughts there on the clinician's sophistication in terms of when you actually do start to get closer to everything you're looking at? What do you expect to see there based on the feedback you've already had and I'll hop back. Thank you.

Greg Demopulos

Management

Yes, very quickly I think the answer to that is we're seeing excitement, we're seeing excitement and enthusiasm. It's manifest in the number of requests we get for compassionate use and that's compassionate use for patients who for one reason or another don't qualify for our clinical trials. It also includes compassionate use for patients who have completed the clinical trial, but their docs want to keep them. Their treating physicians want to keep them on the drug because of the benefits that they're seeing. So I think and as an example just the C3 glomerulopathy patient, that information came to us from an investigator who had seen those biopsy data. So I think it's a safe comment for me to make that there is significant enthusiasm. There is significant excitement across these indications for what 721 is doing. As I did say, it's pretty clear. We certainly believe investigator certainly believe that 721 is truly saving lives and that's a pretty -- that's a pretty daunting statement. It also is pretty wonderful one and all of us here are very excited about the prospects for the drug.

Steve Brozak

Analyst

Great. Again thank you for the detailed feedback on all the different functions. Very exciting. Again thanks.

Greg Demopulos

Management

Thanks Steve.

Operator

Operator

Thank you. And our next question comes from Serge Balenger of Needham & Company. Your line is now open.

Serge Balenger

Analyst

Good afternoon, Greg. Just two really quick questions for me, first one on Omidria, can you talk a little bit more about the sales in the third quarter? You mentioned there was some summer slowdown, but I guess give us a little more detail than we saw in gross reacceleration coming out of the quarter to give us confidence that we'll see growth that matches a little bit more of what we saw in the second quarter?

Greg Demopulos

Management

I think there is a summer slowdown associated with surgical procedures surgical products many speak of it, I think we experienced it. July and the first half of August we're pretty slow and variable bright spotty orders from accounts would be larger and then effectively diminish or disappear for a bid and then come back. And what we found was that those were likely tied to vacations or not only for the surgeons but for patients and just decreased patient numbers. Second half of August, those numbers started to pickup. They continued accelerating through September and they've continued to do so. I think I noted that in September we had a 21% increase over June, so on that three-quarter racist, I'm sorry on that three month basis. So yes we do expect that the increase coming out of the summer months is going to continue, as I said that our current annualized run rate based on net sales only is in excess of that $55 million. So clearly we've continued to grow and we expect we will continue to do so.

Serge Balenger

Analyst

Okay. I think in the press release you mentioned that after the CRG debt facility I guess you have pro forma cash balance around $55 million and that provide you about a 12-month runway. Just want to know what that includes in terms of taking some of these short term goal forward OMS721 as five of them and there's a few more.

Greg Demopulos

Management

It's a good question what we said there was holding with cash on hand, holding our current revenues fixed. So not growing them just holding them fixed and holding our OpEx fixed we had in excess, we've got at least 12 months of working capital. I do not expect and again this is not guidance, this is simply my statement I certainly don't expect that Omidria sales are going to stay fixed where they currently are. The product is gaining traction. We're seeing it in the hospitals. We're seeing it in the ASEs. We're seeing it in the very large facilities, where a large number of procedures are done. The clinical advantages are clear. The docs understand that well and interestingly the administrators are beginning to understand that well also and I think that's serving us very well, but that statement is based on holding everything fixed where we are including OpEx. OpEx will increase as you know with the kind of opportunities we have on 721 and other drugs we're clearly going to going to prosecute those opportunities. I think that we can do that in a cost effective way. I think again based on track history, we've done -- we've done quite a good job I think would be an understatement. We've done quite a good job of managing expenses and moving programs forward. I don't see any change in our ability to do that now with these programs as well.

Serge Balenger

Analyst

Okay. Thanks for the pipeline update.

Greg Demopulos

Management

Thanks Serge.

Operator

Operator

Thank you. And our next question comes from Jason Kolbert of Maxim. Your line is open.

Lauren Chung

Analyst

Hi, can you hear me?

Greg Demopulos

Management

Yes, I can hi.

Lauren Chung

Analyst

Great. I am calling for Jason and this is Dr. Lauren Chung. I have a couple questions, one is OMIDRI's sales OUS, and secondly, OMIDRI's FDA required clinical trial and pediatric clinical study and where that is and when we expect to see the data and a little more update on OMS824 in Huntington's disease?

Greg Demopulos

Management

Okay. Let me first answer your question about ex-U.S. We do have sales that we expect to begin this quarter in the Middle East and we will provide an update on that once those are initiated in and when we have something substantial to say about it, but we do expect sales to begin in the Middle East this quarter. With respect to Europe our objective has always been to build the U.S. market to drive better terms pricing in Europe. We continue to hold to that same strategy and we will update everyone when we have something to report on Europe. With respect to the pediatric study, I do expect that there will be upcoming news that we'll be putting out on that pediatric study. What specifically was the question on A24 I didn't catch that.

Lauren Chung

Analyst

Clinical update on when we expect to see more progress in those studies?

Greg Demopulos

Management

With respect to A24, this has been a program where we have not wanted to repeat what Pfizer has already done. Pfizer is running a very -- a good-sized and complex study of Phase 2 program on their PDE10 inhibitor according to Clinttrials.gov and I have really no better information than then you do just by accessing that. But the information that we have based on what is public, is that Pfizer apparently has completed enrollment in that study. So we are expecting don't know if they've had data lock yet, but we are expecting data from that study at some point in the relatively near future. Based on those data we'll make a decision about how we want to progress with respect to our PDE10 inhibitor. As part of that frankly we're also looking at Takeda's PDE10 study in schizophrenia and again assessing what those data look like and will look like relative to our OMS824.

Lauren Chung

Analyst

Thanks and just lastly on the compassionate use for OMS721, is it being used right now in all five of those indications that you mentioned?

Greg Demopulos

Management

I think boy, this would be of a better question for our clinical team. I do know that we have patients on in compassionate use who have the following indications; aHUS, stem cell transplant related TMAs, C3 glomerulopathy. I don't believe that we have a patient currently on compassionate use for IGA, although I know there have been requests that have come in for continued treatment with 721 for IGA and that we may have a similar situation for membranous I just frankly don't recall or did not know.

Lauren Chung

Analyst

Thanks very much.

Greg Demopulos

Management

Thank you.

Operator

Operator

Thank you. And our next question comes from Elemer Piros of Cantor. Your line is now open.

Elemer Piros

Analyst

Thank you very much Greg. I would like to ask have you noticed any attrition to some accounts that stop ordering for some reason.

Greg Demopulos

Management

What we have seen is this is sort of a temporary attrition. So what we'll see our patients, I'm sorry our facilities who are ordering and some of these and it's not a large number, but we are certainly on top of it, some of these patients may have delays in reimbursement and based on those delayed reimbursements we'll suspend ordering until they see that those reimbursements have been have been cleared, have been received and everybody's comfortable then they reorder again. So I think that's we have seen that occasionally and we do everything we can through our OMIDRIAssure program, also through our reimbursement team to facilitate in any way we can and assist the facilities in obtaining the appropriate reimbursement.

Elemer Piros

Analyst

Thank you. And do you see OMIDRIAssure growing linearly proportional to overall sales?

Greg Demopulos

Management

Its good question and I don't have -- I don't have a good answer for you. I know that OMIDRIAssure is growing and the use of it is becoming more facile and the facilities are becoming more comfortable with the use of OMIDRIAssure. So I think it's becoming more seamless and as a result of that and frankly as a result of the increased volume that we're selling we're seeing an increased utilization of OMIDRIAssure. Whether that is frankly directly linear or whether there is some curve to that slope I can't answer Elemer I would have to go speak to our clinical and commercial teams to get you that answer, but both are growing.

Elemer Piros

Analyst

Okay. So what would be the explanation for the difference between volume growth and revenue growth? Is it almost entirely due to the fact that you have introduced the product to hospitals this quarter?

Greg Demopulos

Management

Primarily that's the reason, remember we have worked very hard to protect ASP and we've done a very good job of it. With respect to our fees what we are able to characterize as bonafide we have worked assiduously I would say to protect our ASP. You know that we do not take an ASP hit when we sell either to government agencies, VA's or under the 340B program, does not affect our ASP in any way, but it does affect revenue. There is a discount that 340B is received that is government mandated at about 23.9% I think 23% something and then we have actually increased that discount somewhat modestly for the 340B facilities all three 340B facilities. So that does hit our gross to net spread.

Elemer Piros

Analyst

Okay. And I just have one OMS721 question the patient that you reported on the aHUS patients, while they're continuously being treated and can they just roll into the Phase 3 trial or they have they been treated for a period of time and now they are waiting for the sites to open up for the Phase 3?

Greg Demopulos

Management

No remember that we have several stages in our AA current aHUS trial and so we have built into the protocol the ability to treat patients aHUS patients for longer-term and it is possible that those patients would roll into the Phase 3 clinical trial. How many of them we would roll in we would have to see because I'd have to meet all of the inclusion, exclusion criteria, which will be similar. But that you know there could be some differences there and we'll have to see how many we can meet and I wanted to make just one more point on that OMIDRI question that you asked because I think I see where your -- I want to make sure I'm answering your question. I want to be clear that our focus on hospitals is not out of a desire to lose money. So the reason that we're focused on hospitals is because once we're in there, we are selling broadly and once you're in some you are selling in others and it is -- we can take a bit of a hit in terms of the revenue per hospital but overall given cost of goods and everything else, that comes to bear in this calculation clearly, it is a commercially viable not just viable, but commercially attractive approach for us to be selling into the hospitals and that's why we're focused there as well.

Elemer Piros

Analyst

Understood. Thank you very much Greg.

Greg Demopulos

Management

Thanks Elemer.

Operator

Operator

Thank you. And our next question comes from Thomas Yip of FBR and Company. Your line is now open.

Thomas Yip

Analyst

Hey everyone. Hey Greg congratulations on a very eventful third thousand 2016 for both Omeros and 71 specifically, first a couple questions about OMIDRIA, you mentioned that OMIDRIA as of now $55 million annualized revenue based on weekly sales run rate, did you measure this run rate, you mentioned slower sales in the summer months, that you mentioned as a run rate in say August or September. We probably did, I think we've given those are included in the data that we provided. Those were in the $11.3 million. What we're reporting now is effectively a snapshot of where we currently are running. As I mentioned I think in response to Sirjay's question, we found July in the first half of August to be relatively spotty and just the variability. Sales continued to grow over the second quarter but it was variable. When we came out the first half of August moving into the second half of August, we stabilized and those sales just continued to grow. So again what I'm giving you with that in excess of 55 is effectively Thomas a snapshot of where we currently stand on a net revenue basis.

Thomas Yip

Analyst

Sure that make sense and the process get to see growth pickup in the fourth quarter with that said, are there any updates a few other markets that Omidria can tap into in 2017?

Greg Demopulos

Management

Again yes it's a good question. We expect that we will have sales in Q4. I don't expect those to be enormous sales coming out of the Middle East. We're going to be ramping up in the Middle East, but we expect those sales to begin in Q4 and then move through obviously 2017 and beyond. With respect to Europe we really don't discuss our partnering efforts other than that we do maintain a presence in Europe. Were maintaining a presence in Europe for a reason and that is that we do expect to commercialize Omidria in Europe and potentially in other regions. So with that I'll tell you we'll update you when we've got something more meaningful to tell you.

Thomas Yip

Analyst

Sure. That's reasonable. One final question I just want to make sure, we understand the pro forma cash question correctly. So you ended the quarter with 47.4 mil and then 10.8 in restricted cash. So with the new loan agreement that will be in that session an addition of $3 million in net cash plus $5 million's now freed up from the $10.8 million in restricted cash am I…

Greg Demopulos

Management

You got it. So that puts you with another eight which puts you at about $50 million, $55.5 million

Thomas Yip

Analyst

Okay. Okay thanks again for taking my questions and looking forward to fourth quarter call.

Greg Demopulos

Management

Thanks Thomas and thanks for your kind comments at the beginning. I appreciate it.

Operator

Operator

Thank you. And our next question comes from Liana Moussatos of Wedbush Securities. Your line is now open.

Liana Moussatos

Analyst

Congratulations on all your progress pipeline expansion and…

Greg Demopulos

Management

Thank you, Liana Moussatos.

Liana Moussatos

Analyst

So with all these clinical trials going on, which ones are going to have data releases in 2017?

Greg Demopulos

Management

Boy now you've cut me having to think about just specifically what -- I expect that you will see additional data coming out of the 721 program in 2017. I think that there could certainly be in the nearer term data coming out of the renal program. There could be data coming out of the stem cell program, the aHUS program will be enrolling in Phase 3. I'm not sure whether our clinical team will be putting out data from the aHUS program next year. But I think that we would expect to see if not out of aHUS and again would wanted to defer to clinical on that, but I would certainly expect that there is a reasonable likelihood that we would see data coming out of the renal program, data coming out of the stem cell program.

Liana Moussatos

Analyst

What about addiction.

Greg Demopulos

Management

That's a possibility as well and when addiction you mean the PPAR-gamma program, that is a possibility. The PDE7 program we expect to have in IND or CTA in the latter part of next year. So any data coming out of that program would be the mechanistic data or the preclinical data, the animal data and we do plan as I think I mentioned to have a publication which we'll be detailing not only the animal data, but the mechanism and the mechanism is very exciting. PDE7 is a very exciting target for addiction and that is -- I think that's a sentiment that is shared by a number of the experts in addiction.

Liana Moussatos

Analyst

Okay. And then when does the pass through reimbursement end and what are the minimum market cap required for their credit facility?

Greg Demopulos

Management

Oh! Two very different questions. Let me answer the first one. Pass through, our pass through period ends midnight December 31, 2017. We are working diligently and frankly the day we received pass through, we turned our attention to how do we -- how do we secure long-term reimbursement for the product. We remain optimistic about our chances of getting that done. We'll update people as again we have something to say specifically there. With respect to the market cap it is dependent on the amount that we have taken down. I think that it's about 6.4 times the aggregate principal outstanding. So on the $80 million it's about $512 million, but just any amount we've taken down or the outstanding principal remaining on that loan, it's just -- it's just 6.4 times that amount. It was a very mathematical approach to determining what those numbers would be.

Liana Moussatos

Analyst

Thank you very much.

Greg Demopulos

Management

Thank you, Liana.

Operator

Operator

Thank you. And that completes the Q&A part of the call. I would like to turn the call back over to Dr. Demopulos for closing remarks.

Greg Demopulos

Management

Thank you, operator and thanks again to everyone for taking the time to listen in. I know we had a lot of material today. We very much appreciate your patience as we went through all of that, as you know it's been a busy quarter and when we recap that, there is just an awful lot to talk about. We do expect to provide additional information on a number of our programs before year-end and as always, we appreciate your continued interest and your support of Omeros. Everyone please have a good day. Thank you.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone have a great day.