Omeros Corp (OMER) 2015 Q2 法說會逐字稿

Good afternoon and welcome to today's conference call for Omeros Corporation. At this time all participants are in a 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 Web site for one week from today.

I'll turn the call over to Mr. Mark Metcalf at Omeros.

Thank you. Good afternoon and thanks 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 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 and then Mike will provide an overview of our second quarter financial results. We have some time reserved for questions after the financial overview.

I'll begin with an update on the US launch of our FDA approved product, Omidria. As most of you know Omidria prevents intraoperative miosis or pupil constriction and reduces postoperative pain, providing consistent and predictable management of these problems for ophthalmic surgeons and their patients.

Following our controlled launch in February we initiated the broad launch of Omidria in mid-April, making product available through the specialty groups of the three major wholesalers in the US. As Mike will discuss further in the financial update, our second quarter of Omidria net sales were $3.1 million.

Now I will discuss some of the specifics. First, what is required to convert a surgeon or a facility to an Omidria user? Efficacy reports from surgeons have been outstanding. In the majority of cases the key is reimbursement. The initial selling cycle for the product is generally around 10 to 12 weeks following the decision to trial Omidria. Once that decision has been made, the next step usually is obtaining and performing a select number of cases with product samples. This allows the surgeon to experience firsthand the significant benefits of Omidria.

Next, generally a single-digit number of vials is ordered, used and run through the reimbursement process. While the reimbursement from Medicare is relatively quick -- on the order of two to three weeks -- any commercial component including a Medicare secondary payer in this early launch phase can take as long as 6 to 8 weeks. The second order usually occurs only after reimbursement is received with the total cycle running, as I said earlier, generally about 10 to 12 weeks from the time the decision is made to try Omidria.

Often during this process the facility administrator, the individual largely responsible for the facility's finances, also needs to be on board, again underscoring the importance of successful reimbursement. Once this initial selling cycle is complete, the conversion rate is high.

So now let's discuss where Omidria stands with respect to reimbursement. As most of you know, Omidria received pass through designation from the Center for Medicare and Medicaid Services, or CMS, and the product's reimbursement rate has been set at the wholesale acquisition cost, or WAC, plus 6%, converting on October 1 of this year to average selling price, or ASP, plus 6%. 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.

The payer mix for Omidria is unique in that it is heavily biased to the Medicare population and these claims are adjudicated by the Medicare administrative contractors, or MACs. I am pleased to inform you that we have confirmed that 100% of all MACs across all US states and Puerto Rico reimbursed based on the rate of WAC plus 6% set for Omidria by Medicare. Medicare advantage and commercial claims for Omidria also have been reimbursed, often above the Medicare reimbursement rate.

With respect to commercial payers, let me provide a bit of perspective. The top 30 commercial payers in the US represent approximately 153 million insured lives. To date, for Omidria we have secured coverage either by reimbursed claims or direct discussion with or other information from the respective payer from nearly all of the top 30 commercial insurers, including Aetna, Cigna, Humana, Tricare, WellPoint Anthem, and United Health Group representing approximately in total 133 million of those 153 million insured lives.

Additional insurers, including AARP, USAA and many of the Blue Cross Blue Shield organizations, have also been confirmed. This level of penetration has been very rapid, requiring only four months, and our six person reimbursement team in the field continues to build on that success.

The clinical response of surgeons to Omidria continues to be outstanding. Surgeons have used the product across both routine and difficult cataract cases, including intraoperative floppy iris syndrome, or IFIS, and pseudo exfoliation as well as in conjunction with femtosecond laser and the reported results have been consistently positive.

Cases in which surgeons expected to need mechanical pupil expanding devices were easily completed without them when Omidria was used. Surgeons who have performed a good number of Omidria augmented procedures report that their utilization of these costly devices has decreased substantially when compared to cases performed prior to the availability of Omidria. And many report, in fact, having never needed to use a pupil expanding device with our product.

So with the clinical reality that once surgeons use Omidria they appreciate the drug's significant benefits and recognizing that confidence in reimbursement is a driving factor in the adoption of Omidria, we have pursued avenues by which to expand access to Omidria across patients insured by government and commercial payers. To these ends, in recent months we have one, signed a contract for sales under the Federal government's 340B program which provides discounts to healthcare providers serving low income patients includes most academic institutions and many large hospitals.

Two, entered into a Federal supply schedule, or FSS, agreement under which certain US government purchasers such as facilities managed by the Veterans Administration and Department of Defense again receive a discount on eligible purchases of Omidria. And three, executed a Medicaid drug rebate agreement with CMS which provides a rebate to participating states for purchasing Omidria. We also have focused on the national and regional chains of ambulatory surgery centers, or ASCs, and have made good progress.

For example, AmSurg, the largest ASC company in the market today, supports at even its highest corporate management levels the use of Omidria in its member facilities. To make Omidria accessible by all patients, Omeros is establishing both a patient assistance program and a commercial co-pay program. The patient assistance program will provide a free vile of Omidria to patients who meet certain financial criteria and would otherwise bill government insurance such as Medicare patients. This is expected to be a limited number of patients given that approximately 90% of Medicare patients also have supplemental or secondary insurance.

In the commercial co-pay program, Omeros will financially assist patients whose commercial coverage inadequately reimburses for Omidria. Given the strength to date of Omidria reimbursement, we do not expect either of these programs to have a detrimental effect on the Omidria net sales price or revenue. Together the assistance -- the patient assistance commercial co-pay programs should remove any remaining financial impediment to use of Omidria by qualifying patients. If we believe in the benefits of Omidria, and we do, we should act accordingly and ensure that all patients can access it.

On the marketing front we are maintaining a strong presence at key ophthalmologic conferences and within the ophthalmic surgery community. We have strong relationships with, and are sponsors of, a large number of medical professional societies including the American Society of Cataract and Refractive surgery, the American Academy of Ophthalmology, the American-European Congress of Ophthalmic Surgery, the Vanguard Ophthalmology Society, and the Cornea External Disease and Refractive Society together with the American Society of Progressive Enterprising Surgeons.

In addition, we have partnered with associations that advocate for surgery centers and focus on the business of surgery, including the Outpatient Ophthalmic Surgery Society, the American Academy of Ophthalmology as Ophthalmic Business Council, and the Ambulatory Surgery Center Association. We continue to increase the number of both peer reviewed journal publications and trade journal articles as well as advertorials and advertisements.

Our speakers bureau, consisting of a group of the top thought leaders in cataract surgery and lens replacement, is active and well received. Our advisory board now includes even some who initially were vocal critics of Omidria, a testament I believe to the compelling clinical utility of the product once surgeons have the opportunity to understand its benefits for them or their facilities, and most importantly for their patients.

With respect to Europe, Omidria received approval from the European Commission to market Omidria in all EU member states plus Iceland, Liechtenstein, and Norway. Similar to its broad indication in the US, Omidria in Europe is indicated for use during cataract surgery and other IOL replacement procedures to maintain mydriasis, pupil dilation, prevent miosis, pupil constriction, and reduce postoperative eye pain. Decisions about price and reimbursement for Omidria are made on a country by country basis and will be required before marketing may occur in a particular country.

We have established a European advisory board for Omidria, consisting of top thought leaders across Europe and are strengthening our presence within the European Society of Cataract and Refractive Surgery. Our European strategy remains the partner for the product's marketing and distribution and we expect that success in the US will only help us as we move to commercialize Omidria in Europe.

Turning now to our other products, last quarter - last quarter we also secured a US marketing and distribution partner for our arthroscopic product, OMS103. We entered into an exclusive licensing with Fagron Sterile Services and affiliated JCB Laboratories and sales are expected later this year. OMS103 added the standard irrigation solution used in arthroscopy is Omeros' proprietary PharmacoSurgery product designed to provide a multimodal approach to block preemptively the inflammatory cascade induced by arthroscopic surgical procedures surgeons.

Orthopedic surgeons are excited about the product particularly as it has become increasingly evident that inflammation is directly tied to detrimental effects on the long-term health of the joint. In addition to its current US sterile and fully GMP compliant manufacturing capabilities, later this year Fagron is scheduled to open one of the country's largest FDA registered 503B human drug outsourcing facilities which is expected to utilize automation not yet seen in the nation's sterile compounding industry.

Together with Fagron's current operations, this state-of-the-art outsourcing facility is planned for use to produce commercial supplies of OMS103. Under the terms of the outlicensing with Fagron, Omeros will receive royalty payments representing a substantial majority share of gross revenue from Fagron's OMS103 product sales within the US. We are also eligible to receive up to an aggregate total of $10 million in potential payments upon the achievement of specific commercial milestones and as revenue share enhancement on early sales.

Fagron is obligated to meet performance diligence requirements, including the commencement of commercial supply of OMS103 in 2015, to bear all sales and marketing costs, and to meet annual sales volume minimums. As part of Omeros' obligations, which include maintenance of the licensed intellectual property, we have begun introducing Fagron to the thought leaders supporting OMS103. As a result of this agreement we will incur no further development costs in connection with OMS103 other than those required to maintain the intellectual property.

With Fagron's robust sterile GMP manufacturing and commercial capabilities we believe that Fagron really has the reach and expertise to bring OMS103 to orthopedic surgeons and their patients across the US. The agreement also lays the foundation for Fagron and Omeros to expand the territories for OMS103 beyond the US and to enter potential partnerships for additional products from Omeros' PharmacoSurgery platform.

Turning to our pipeline, let's first focus on our MASP-2 program. Our MASP-2 antibody, OMS721, targets the lectin pathway of the complement system, a key part of the immune response. Our current phase 2 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 2 trial specifically is assessing OMS721, an atypical hemolytic uremic syndrome, or AHUS, thrombotic thrombocytopenic purpura, or TTP, and human stem cell transplant related GMAs. The FDA has granted our 721 program both orphan drug status and, as announced in late July, fast-track designation. Orphan drug status provides for seven-year market exclusivity, ongoing interaction with and assistance from the FDA, significant tax credits, possible research grants and a waiver of the NDLDLA multi-million-dollar application fee.

Fast-track is designed to facilitate the development of drugs that have the potential to address unmet medical needs and are intended to treat serious or life-threatening conditions. We remain pleased by the progress of the phase 2 trial and by the participating physician investigators' collective confidence in OMS721 as evidenced by the ongoing physician requested compassionate use program in which patients currently are being dosed with OMS721.

As a reminder, our phase 2 TMA trial consists of a three level dose ranging stage followed by a fixed dose stage. We recently completed dosing in the mid cohort. Patients in this mid-dose cohort demonstrated improvements across the same markers of disease activity as did the low-dose patients. The high-dose or third cohort continues to enroll. While we have released some information from the low and mid-dose cohort, we understand that some investors are awaiting more detailed results from the trial. We expect to release these more detailed phase 2 data in the near term.

As previously discussed with both orphan drug and fast-track status, we look forward to working with the FDA to streamline the development of OMS721. Strategically we remain on track to discuss with FDA later this year both the data from our phase 2 trial in TMAs as well as our plans for our phase 3 program.

For OMS824, our PDA-10 inhibitor and development for the treatment of cognitive disorders, including Huntington's disease and schizophrenia, clinical trial enrollment, as previously reported, this currently is suspended in connection with an observation in a single nonclinical rat study. In the second quarter we submitted the package of nonclinical materials requested by the FDA. We are currently working with the agency to reactivate enrollment in our OMS824 phase 2 clinical program as soon as possible.

Our preclinical programs also continued to advance. We are working to move one or both of our PD7 inhibitor, OMS527, and our plasma inhibitor, OMS616, into the clinic next year and our mass pre-inhibitor program, OMS906, targeting the complement system's alternative pathway, we now have potent and functionally active antibodies against MASP-3. With respect to our GPCR program we continue to strengthen our intellectual property position and a number of specific targets are advancing through compound optimization and evaluation in animal models of disease including GPR 17 for remyelination, GPR101 for eating disorders, GPR 151 for neuropathic pain, GPR 161 for triple negative breast cancer and other types of malignancies, and GPR 174 for autoimmune disorders including multiple sclerosis.

In addition to our commercial and development successes throughout the second quarter, we also expanded our Board of Directors by adding Dr. Rajiv Shah, recent administrator of the US Agency for International Development, or USAID. At USAID Dr. Shah creatively forged strategic partnerships with corporations and private capital to address some of the most pressing global problems. As we continue to market Omidria as OMS103 enters the market, and as we prepare to commercialize other products in our pipeline, including OMS721, we expect that Raj will be able to help us on a good number of domestic and international fronts and he is a welcome addition to our Board.

That concludes our corporate update. At this point I'd like to turn the call over Mike for a summary of our second quarter financial results.

Thanks, Greg.

For the quarter ended June 30, 2015, we reported a net loss of $16.7 million, or $0.44 per share. This included non-cash expenses of 2.7 million, or $0.07 per share. This - this compares to a net loss of $18 million or $0.53 per share for the same period in 2014 including non-cash expenses of $2.2 million or $0.06 per share.

Revenue for the quarter was $3.2 million, $3.1 million of which was Omidria product revenue. As Greg mentioned earlier, we began the broad US launch in mid-April, began selling Omidria primarily through the wholesaler channel at that time. Our general policy is direct managed revenue upon a mid-year -- Omidria receipt by the wholesalers, the selling method.

During the second quarter we also entered into agreements which allow 340B eligible hospitals and federal agencies to purchase under the Federal supply schedule to purchase Omidria at a discount. We estimate a reserve for these discounts and rebates when we recognize revenue on sell to the wholesaler.

Total costs and operating expenses for the second quarter were $19.2 million compared to $17.3 million one year ago. The increase was primarily due to sales and marketing expenses related to the US commercial launch of Omidria. This increase was partially offset by reduced research and development expenses as a result of the timing of manufacturing clinical drug supplies last year compared to this year and a suspension of clinical trials related to OMS824.

As of June 30, we had cash - cash equivalents and short-term investments of $51.4 million. With that, I'd like to turn the call back over to Greg.

Okay, so I guess at this point now what we can do is open the question up -- the call up to some questions. Operator, can you - can you assist us with that?

(Operator Instructions)

Our first question comes from the line of Liana Moussatos of Wedbush. Your line is open.

Thank you for taking my question and congratulations on a strong first quarter launch; it doesn't happen very often.

What part of the $3.1 million in sales of Omidria was due to demand versus channel fill and inventory stocking?

Yes, as we said, we do it on a - on a sell-in method but I can in June it was a pretty standard one month in - in the channel.

Okay, and is that going to be the inventory level maintained going forward one month?

Yes, Liana, we expect that that will be - that will be the amount that is in the channel going forward.

All right. Thank you very much. Congratulations.

Thanks. Thank you.

Our next question comes from the line of Steve Brozak of WBB. Your line is open.

Hey. Good afternoon, gents. I'll make this pretty broad because candidly you're starting with information that is imperfect. Can you tell us what the difference has been between the controlled time period that you were talking about initially and what it is today? And also, the follow-up on that would also be can you explain what the previous standard of care was in terms of compounding as it is today? And I'll hop back in the queue.

Sure. Thanks, Steve. The first question that you had is what's the difference I think between the controlled launch of the broad launch?

Yes, that's right.

The controlled launch, remember, was -- was a program that we began in mid-February and the idea there was to really pressure test reimbursement and any -- any sort of issues that might arise at the clinic with respect to utilization of Omidria. It was - it was a program that included a small number of our thought leaders, and again the idea there was really just to make sure that all of the processes were in place, both with respect to our -- our ability to get drug to the facilities, the facilities' ability to -- to bring the drug in, use it, and then to secure reimbursement after the drug was used.

Beginning in mid-April, we converted that to really this broad launch which of course as -- as you would expect, was -- was nation - nationwide, it was across the country that we were launching the product, and so that's -- that's really -- that's really the difference.

Does that - does that answer your question there, Steve?

Yes, no, no, it absolutely does. So basically this is a continued follow-up. But in - in terms of the -- the next -- the next part, how does it compare to the control? Specifically how do you go out there and start to talk about what the previous standard of care was, which was obviously compounding compared to what the standard of care is today?

Right, well, you know, prior to Omidria I'm - I'm not sure that there was really any standard of care. Compounding was the only option, but the numbers and type of drugs were quite very - were quite large and varied. So, it's a little difficult to compare, frankly, Omidria to those compounded products.

You know, what I can do is I can reference our - our phase 2 full factorial study where specifically we looked at Omidria versus Phenylephrine alone, versus Ketorolac alone, and as you know one of the most commonly compounded products today is epinephrine. Epinephrine is -- is similar to Phenylephrine, the difference being that Phenylephrine is alpha 1 selective, Epinephrine is both alpha and beta active. We - we chose Phenylephrine for its alpha 1 selectivity for inclusion in Omidria.

When we ran the phase 2 B full factorial study looking at Omidria versus, in this case specifically Phenylephrine, Omidria was nearly 4 times better in preventing pupil diameters of less than 6 millimeters. Now, that -- that's an important number because that's - that's a number that, frankly, when Dr. Chambers -- Wiley Chambers of the FDA asked us to examine. And the reason for that is - is simply that pupils less than 6 millimeters in diameter are associated with a multiply increased risk of complications.

So, again, looking at Omidria versus Phenylephrine, Omidria nearly 4 times better. I believe the difference was 22% versus 6% with Omidria. So, you know, there is no compounded product like Omidria. Omidria contains both Phenylephrine and Ketorolac, and remember it is the Ketorolac that is doing potentially here the yeoman's share in -- in preventing that pupil from coming down because it's actually the Ketorolac that stops the miosis or constriction.

Phenylephrine, epinephrine, any of these Mydriatic agents dilate the pupil only. They do nothing to prevent constriction. It's the Ketorolac that prevents the constriction, and that constriction, as you know, is the result of really prostaglandins that just are released during surgery. They are -- they are kind of the natural byproduct of -- of surgical trauma.

And candidly, you pretty much went over everything. It's -- the question now becomes, what are the clinicians saying when they start to see Omidria and, you know, obviously the benefits and obviously you focused on ensuring that payment and repayment is there. What are you - what's the last words you're getting back from the clinicians? And I'll hop back into queue. Thank you.

Well, look, the - the response from the physicians from the clinical perspective has just been outstanding. Even, frankly, I believe that most physicians, most surgeons when they use the product, even if they're expecting it to work, are surprised by how well it works and that seems to be a consistent theme.

The whole story here is really, for us, reimbursement. It is, can we make the facilities - not just the surgeons, but the facilities and specifically the administrators, the directors, the CEOs of those facilities, can we make them comfortable that they are going to be reimbursed? And, you know, looking at the data to date, certainly seems to be - certainly seems to be that the answer to that is - is pretty favorable.

With the patient assistance program, with the commercial co-pay program, again our focus there is how do we help the patient? As I said in the overview, and we genuinely believe this, look, if we believe in the product, and we certainly believe in the product, we ought to be willing to do what we need to do to make sure that all patients can access it. And that's the reason for the patient assistance program, that's the reason for the commercial co-pay program.

We think that when we put all of these things together, I think kind of the overall picture becomes pretty clear to not only the surgeons who want the best for their patients but, you know, frankly, also the facility administrators who want to make sure that -- that in the end of all of this that they're not -- they're not unduly burdened. And I think that - that we can really satisfy both sides of that equation.

Look, I - I guess what it comes down to is we're all looking forward to the next quarter and to see the numbers and how they grow from there. Thank you, again.

Thanks, Steve.

Our next question comes from the line of Yatin Suneja of Cowen and Company. Your line is open.

Hi, guys. Congrats on a great quarter and congrats on all of the progress. First question on Omidria, I'm not sure if you are planning to tell us, but could you give us a sense of how many lives were shared and then how many procedures were performed in Q2?

And then you made a lot of progress in securing the endorsement from private players, so could you help us understand if there is any pricing differential between commercial versus Medicare? And then I have one more on OMS721.

Right, let me answer the questions in the order in which you presented them, Yatin. I think first, no, we won't be able to provide the - the specific number of procedures performed. Second, with respect to the difference in pricing, when you say pricing I'm - I'm going to answer the question from both hands.

The price of the product is set across -- across all patients, all - all providers effectively at the same price which is -- which is currently the 465. As you know, I -- I gave some examples of specific areas where we may be providing discounts and those are discounts really that are federally mandated, 340B, the VA system, DOD those types of -- of purchasers received by federal mandate discounts and we are complying with those.

So I think with respect to now the other end of this, the reimbursement fees, the commercial payers have been paying, have been reimbursing well for Omidria. So, that has not presented any -- any problem. In fact, as I said, often Fed reimbursement than - than the Medicare reimbursement which is again, is a pass through product based on that set reimbursement of WAC plus 6% converting on October 1 of this year to ASP plus 6%.

Great, thank you. And then, on OMS721, could you tell us how many patients are on compassionate use right now? And then how far have they done in terms of, you know, what's the duration of treatment so far they received the OMS721? Thank you very much.

We haven't - I don't think we put that out yet publicly but, as I said, we do plan to provide some more detailed information on 721 program. As I - as I said in our - in our corporate overview, we - we do understand that there's been a request from some for more detailed data from the phase 2 program and we will be -- we do expect that we will be sharing that, as I said, in the near term.

(Multiple Speakers)

You'll find some of the answers that - that you're looking for.

Sure. Thank you very much.

Our next question comes from the line of Serge Belanger of Needham & Company. Your line is open.

Hi, good afternoon. And seems you providing a lot of details and -- and color on the -- on the [wash]. It's very helpful.

You're welcome.

First, a question, you mentioned the current selling process is a 10 to 12 week process from initial introduction to - to sales conversion, so I imagine at this point most of the clinics and physician groups are - are still in this cycle. What steps are being taken to shorten the - the cycle at this point?

Yes, I think -- and that's a great question. You know, look, we'd like that sales cycle to be shorter as well. I think when -- when taking three steps back it's - it's - it's understandable. This is a - a cost that facilities are - are concerned they could - they could incur in large numbers because, again, there are a lot of these procedures performed, and they just want to be confident in kind of what that reimbursement picture looks like. So everything is sort of -- is sort of tested in -- in small steps until they become comfortable.

Now, once they see the reimbursement coming as - as it has been and as we have reported it to be, you know, they -- their comfort level increases their confidence increases, and that ordering increases. And also remember on the other side of this you have the payers and those payers also have to work out the initial kinks associated with Omidria and the reimbursement for that product. And that - that amount of time should also contract as - as more and more of -- of these claims come in to specific payers.

So we really expect from both ends, from the facility and from the -- from the payer side that that timeline should -- should contract with continued utilization.

Okay. And then in terms of the potential European market for Omidria, I know it's early and we don't have any information on -- on pricing or reimbursement just - but just wanted your thoughts on what you think the - the market can be relative to the US one, and - and whether compounding is also prevalent across the EU states?

Yes, compounding is - let me start at the - at the back of that, compounding is prevalent as they call it over there, it's sort of the kitchen pharmacy approach. Different people do different things, there is no standard just as there is really has been no standard in the US. The -- they don't, you know, the US obviously with the Drug Quality and Security Act, with the FDA's public statements on compounding, there's substantial scrutiny around compounding now and -- and increasingly stringent regulations around compounding in the US.

Europe does not have at present that same level of scrutiny or -- or regulation around compounding. What - what they do have are physicians who do want a standardized approach to providing the benefit that -- that Omidria provides. As I - I mentioned in the overview, we are working with a group of the top ophthalmologists across Europe and the response, as in the US, has been uniformly positive product. They get the - the get the science, they get the clinical component of it.

Reimbursement in Europe, as you know, is going to vary from EU state to EU state. All of that will need to be worked out as -- as we go forward. Our plans in Europe strategically are to partner for - for the European market. So, that - that's the present plan. We do expect that success will have a significant impact on uptake in Europe. And I think, you know, and this - I think the reverse would be true as well. If we had initially launched in Europe, I would expect that success in Europe would - would affect our success in the US.

So this is not West-centric comment, I'm just simply saying that the success we expect will meaningfully impact success in Europe.

Okay. One last one, I'll get into queue. I think you've mentioned in the past your ability to dial up or down or up your OpEx depending on R&D priorities.

Yes.

I'm sure Omidria remains the focus in the company, but when you think of R&D I guess, does this company have the bandwidth to take 721 and 824 forward?

Yes, it does. Both - both from sort an intellectual resource and also from a capital resource. You know, we are pushing full speed ahead with 721, and 824, as soon as we can - can get that back and the clinical trial started, we will be - we will be pushing hard on 824 as well. But, you know, rest assured that 721 for us is - is a very high priority right now.

Okay, thank you.

Our next question comes from the line of Thomas Yip of MLV & Company. Your line is open.

Hey, guys. Thank you for taking my questions and congrats on a very nice quarter, both for Omidria and your other pipeline which is 721.

Just want to follow on on a point that you made earlier. So regarding the early sale cycle of Omidria. So, from what I understand is customers order, that would be the first cycle, and then they wait for reimbursement before they order the second batch and that process would take between 8 to 12 weeks from - if I listened correctly. So should we expect to revenue over the next 12 months to be somewhat lumpy between quarter-to-quarter?

No, I don't think - I don't think, Thomas, that - it's a good question, but I don't think that we would expect lumpy revenue. And I understand the reason why -- why you might think that.

I think that what you've got are really - you've got waves, and those waves continue to smooth out over time. So, I would expect that -- I would expect that once -- once that -- that sales cycle has gone through, as I said, you know, really want one or two sales cycles. By the time someone has - or a facility has purchased that second order, I would consider those really are our customers, those are -- those are pretty loyal customers. And I think that -- that -- that really levels out any sort of lumpiness that - that you might be anticipating.

Okay, got you. And one question for 103, so what -- from what I understand, Fagron has pretty much, you know, they're - they're pretty in the driving ? driver?s seat to takeover program for the -? that is for the for US market, so what's left for them to do before it can be officially launched in the US?

Yes, they - they will be gearing up the manufacturing of the product and also, as - as I mentioned, we are really plugging Fagron into - into our key opinion leaders or our thought leaders across the country. They're - they're very excited about the product, both the - the thought leaders and Fagron. They're looking at really multiple applications for it, applications that we had considered as well when the product was -- was with us.

So, I think there is -- there is some work for them to do, but again under the agreement they are obligated to - to begin sales this year.

Okay, great. Got it. One last question for - for the European market. You mentioned Omidria could be market only out there, reimbursement has been established on a country by country basis, and also you plan to out-license from what I assume to be for each specific geographical region. So, do you plan to tackle some of this - sure.

Yes, let me just - let me just make sure that - that I made this clear. I - I did not mean to imply, and if I did apologies, that we are going to be partnering region by region. That's - that's not -- we -- we've not said that is the strategy. The strategy could very readily be partner for all of Europe.

I just want to make sure that -- that we're -- that I made that clear.

Sure. So, do - do you plan to tackle any of that reimbursement work on your own first or do you plan to let the partner, a potential partner, to kind of lead that effort?

You know, we're going to be more than willing to work with our partner, to support our partner in whatever way our partners --in whatever necessary to -- to address those reimbursement issues, but I -- I think that just realistically the heavy lifting of that is going to be borne primarily by our partner or partners.

Okay, thank you. Thank you so much, and congrats again on - on a very great quarter for Omidria.

Thanks, Thomas. Thank you.

Our next question comes from the line of Elemer Piros of Roth Capital Partners. Your line is open.

Good afternoon, Greg and Mike. How are you?

Hi, Elemer. How are you? Well, welcome back.

Yes, thank you. Thank you. Good to be back. And Greg, so just almost up 30, or nearly all 30 top tier payers that cover 135 lives, now the next year, would there be a -- a more detailed or a more labor intensive process, or do you think that by virtue of having these nearly 30 would allow the dominoes to fall -- the pieces to fall into place in the -- with those other smaller payers?

I think -- I think more the latter, Elemer. Remember that, you know, and we're not making comparisons here but in general pharma and in general large pharma looks specifically at those top 30 payers across the country. We were able to achieve this kind of coverage and, you know, we're not done yet. As I said, of the 100 million covered by those top 30 insurers commercial payers, we have currently about 133 million of those insured lives covered.

Now, remember when I say covered, you know, that - that can be also plan-specific. So, if a specific plan, and I'm not going to name anyone just so that I'm not offending anyone, but if a specific retailer, for example, carved out cataract surgery from -- from their specific plan even though the payer covers it, that -- that plan might -- might not then cover cataract surgery and/or

Omidria. But the 133 million covered is - is, you know, really from our perspective tremendous progress.

When you get beyond that number you start getting into relatively smaller lives covered. Now again, we have to look at which ones there - there are two - there are two ways to look at these numbers. One is what - what are the top 30 just in terms of number of insured lives and then there is also which ones are really most - most influential in specific regions -- and we're also working through those.

I think the takeaway message here is that we've been extremely successful, and I think, you know, I'd like to take the credit for that, that this is really our team that has done this and - and give the credit there to our team and I think it's appropriate, but I think also there is credit due to the - to the product itself. It's - it's Omidria and I think the insurers recognize that, you know, gee, it's - it's going to be hard perhaps not to cover that when it is the only FDA-approved product for that indication in the market.

I think that that would, you know, to deny coverage there would be at least a potentially untenable -- untenable position. So I think it's really a combination of the hard work of our team here at Omeros and also just purely the - the importance of the product.

Yes. So if we could discuss a little bit about the range of reimbursement. If you think about the $465 list price, if you will, you mentioned that some of the private payers, the actual net revenue that you receive is higher and you have to give government mandated discounts in other instances. If you were to characterize the ranges above and below the $465, how would they - what would those ranges be?

(Multiple Speakers)

Are you - are you asking, I'm sorry. I want to make sure I understand, Elemer. Are you saying that the range in price?

Yes.

Because the price - the price - the price that - that the - that the provider is paying, the price that we are charging is never higher than $465, it only goes downward with respect to discounts on those, for example, those federally mandated discounts associated with the 340B institutions, with respect to the VAs, the DODs, that -- that type of discount. But we aren't -- there is no upward fluctuation in the pricing.

Is -- is that...

(Multiple Speakers)

Because I've hear that in some instances some private payers reimbursed at a level higher.

Well, now we're talking about reimbursement, though. I - so, when - I - I'm sorry, I might have misunderstood. I thought you were talking about price.

With respect to reimbursement, yes reimbursement can vary. You know, the - the reimbursement off of the Medicare is really set by Medicare at that rate of WAC plus 6% which, as of October 1, flips to ASP plus 6%. With respect to commercial payers, the -- the reimbursement amounts have varied and, as you know, often reimbursement on the commercial side is based on percent of billed charges. And so it is - it is at times higher than the reimbursement rate provided by -- by Medicare, by CMS...

But is that going above $465?

Yes, that would be - that would be above the $465 plus the 6%, yes.

Okay, okay. Now I know that you're not going to - you stated that you're not going to disclose the volume or the number of procedures performed. Is there a way for you internally to determine what's the true demand for Omidria?

Well, yes, sure there is. I mean, again, I think the - I think the utilization of the product, the number of vials we're selling indicates to us what is -- what is the demand and is that demand expanding. You know, I think -- I think again if we come back to a more global view of - of how we view the progress of Omidria, how are we doing clinically? Well, you know, when docs use this product, they like this product. So the clinical piece seems to be pretty well put to bed.

So the question is, reimbursement, reimbursement, reimbursement. And -- and how do we help get the facilities comfortable that these procedures using Omidria will be reimbursed, the product will be reimbursed for use in their procedures. I think what we shared with you today is a pretty positive picture about the overall reimbursement efforts and the overall reimbursement success associated with Omidria. Clearly that is going to be an area of focus for us. I mean I think that as - as that level of confidence in reimbursement increases, I'd have to question what other impediment could there be?

You have the only FDA approved product. When you use it, you like the way it works. In fact, as, you know, again, these are - these are not controlled studies, but we've had the reports from so many clinicians coming back saying that they've reduced their use of these pupil - these mechanical pupil expanding devices, and in many cases frankly eliminating them to date. Those cost money, those pose risk to patients, they're a problem.

You know, when you put these things all together, you start to think, gee, if - if that reimbursement piece -- if that confidence level is high, what should be the impediment? And I -- I'm sure there are some, but I think overall, you know, you've addressed the two large drivers. One is clinical and one is reimbursement.

As I said, we think the clinical is - is pretty clear and the more the docs learn about the product, frankly, the more they appreciate the benefits. So it's really the - it's really the reimbursement and I think we've - we've helped, at least I hope we've helped today, clarify that situation.

Yes, thank you. And just a couple of record questions here, do you have a conference in mind where you would present 721, OMS721 data?

Yes, I - I think that, though frankly the more detailed 721 data will probably come out as a press release.

Okay, got it. And I noticed that SG&A has dipped by $1 million. Which of the S, G, or A did go down? So I may address this to Mike, and how should we look at this item for the third and fourth quarters of this year?

Yes, I would look at SG&A for the - as you kind of look forward is, you know, the sales force is in place, it - and somewhat associated with the amount of advertising and the conferences and that kind of thing that we go to. It is a little bit adjusted based on time of year because the conferences tend to be in the fall and in the winter versus in the middle of the summer. But if you look at it going forward, you know, sales and marketing should be pretty consistent.

G&A migrates a little bit based on the kind of activities we're doing, but generally speaking I wouldn't look for massive changes in SG&A.

As opposed to - or versus the first quarter of this year?

Yes, I mean, we did more stuff in the first quarter primarily with the sales and marketing stuff getting ready for the launch itself. So, the first quarter the sales and marketing numbers were a little bit higher than they were in the second quarter.

Got it. Got it. And one last question, Greg, do you expect to have any patents issued related to the GPCR platform this year?

You're - you're asking me to predict a date. Let me answer it this way, Elemer, I do expect that we will have patents that, and this is my personal expectation, which is I know what you are asking me. I do personally expect that we will have patents that do issue around the GPCR program. That -- that is not a position that has changed for me. That is -- that position has remained constant.

When that occurs, you know, I would like that to be soon, I would like that to be very soon. But unfortunately I don't - and our team does not fully control that - that timeline so we - we need a cooperative USPTO to work with us on that and, again, my expectation is we will -- we will ultimately have patents around the GPCR program.

Now importantly you're to blame because you overloaded their capacity. Thank you very much, Greg.

Thank you.

Our next question comes from the line of David Cohen of M.S. Howells. Your line is open.

Hey, guys. Great start to the year. Nice job on the quarter. I had a couple of questions, fortunately I see your Q is out, which is fantastic; I get to ask you a couple of questions.

In the inventory line you had $633,000. Was that all Omidria?

Yes.

It was? Well, so, Greg, if you only had 10 weeks of sales and you did $3.1 million that's approximately $310,000 a week. In response to a earlier question you suggested you had four weeks of inventory in the channel and that works out to about two weeks. Did I miss something?

The inventory on the balance sheet doesn't reflect the inventory in the channel. So --

It does not?

No.

(Multiple Speakers)

So what was actual channel inventory at the end of the quarter?

So, we have said that we had about one month --

$1.2 million?

-- of inventory in the wholesaler channel, but that's on the wholesaler books not on our books; as we recognize the revenue on the sell-in method.

Got you. Got you. Excellent. Okay. With respect to the cost of goods sold, the margins appear to be just under 90%. Did you allow your salespeople to distribute samples to any of the doctors? And if in fact you did, were they given a sample pack of two, or were they given one? How did that work?

We did allow sampling, we do allow sampling, David. And, you know, that - that number, frankly, varies from - from group - from group to group and that's - that can be anywhere from, you know four to eight usually.

And David, the cost of samples is recorded in the SG&A expense, it's at the top of the been-sold line.

Excellent. I appreciate that. Thank you.

And then, is there any data on follow-on orders from docs. For example, are you able to give us any statistics on the number of doctors who have re-ordered?

No, we've said the conversion rate is high, David. And I think we're going to leave it at that.

Excellent. Okay, and then once again within the - within the last - you've had another approximately six weeks since the end of the quarter. Are you seeing any acceleration in demand for the product?

We haven't - we haven't talked about what's happening this quarter. We will talk about that at -- at the next earnings call.

Okay. I think that was all I had. Once again, nice start and -- and we'll stay tuned.

Thanks. Thank you, David.

That completes the Q&A part of the call. I?d like to turn the call back over to Dr. Demopulos for closing comments.

Thank -- thank you, operator. And as the operator just said, that -- that wraps up our call for today. Thanks again to everyone for taking the time to listen in.

With the sales ramping up and a favorable reimbursement picture becoming increasingly clear, we believe that Omidria will deliver well for us in the future. OMS103 looks to provide a second revenue stream for Omeros and I would just mention to all to look for upcoming and more detailed data from the phase 2 OMS721 trial and AHUS and other TMAs.

And from time to time as -- as has been our -- our routine, we expect to update you on our progress.

As always, all of us at Omeros appreciate your continued interest and support. Have a good afternoon, everyone. And thank you, again.

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