U.S. Markets open in 7 hrs 52 mins

Edited Transcript of EYPT earnings conference call or presentation 7-Nov-19 1:30pm GMT

Q3 2019 EyePoint Pharmaceuticals Inc Earnings Call

WATERTOWN Nov 8, 2019 (Thomson StreetEvents) -- Edited Transcript of Eyepoint Pharmaceuticals Inc earnings conference call or presentation Thursday, November 7, 2019 at 1:30:00pm GMT

TEXT version of Transcript

================================================================================

Corporate Participants

================================================================================

* David Scott Jones

EyePoint Pharmaceuticals, Inc. - Chief Commercial Officer

* Nancy S. Lurker

EyePoint Pharmaceuticals, Inc. - President, CEO & Director

================================================================================

Conference Call Participants

================================================================================

* Andrew Jacob D'Silva

B. Riley FBR, Inc., Research Division - Senior Analyst

* Dana Carver Flanders

Guggenheim Securities, LLC, Research Division - Senior Analyst

* Edward D. Marks

H.C. Wainwright & Co, LLC, Research Division - Research Analyst

* Kimberly Minarovich

Argot Partners, LLC - MD

================================================================================

Presentation

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

Good morning. My name is Sydney, and I will be your conference operator today. At this time, I would like to welcome everyone to the EyePoint Pharmaceuticals Third Quarter 2019 Financial Results Conference Call. (Operator Instructions) Please be advised that this call is being recorded at the company's request. The company will be referencing a slide presentation during the call, which can be located on the Investor Relations tab on the corporate website, www eyepointpharma.com.

I would now like to turn the call over to Ms. Kimberly Minarovich from Argot Partners.

--------------------------------------------------------------------------------

Kimberly Minarovich, Argot Partners, LLC - MD [2]

--------------------------------------------------------------------------------

Thank you, Sydney, and thank you all for joining us on today's conference call to discuss EyePoint Pharmaceuticals Third Quarter 2019 Financial Results.

With me today is Nancy Lurker, EyePoint's President and Chief Executive Officer; and Scott Jones, Chief Commercial Officer. Nancy and Scott will provide an overview of the recent progress made on our commercial launches as well as highlight our recent corporate developments and detail the third quarter 2019 financial results. We will then open up the call for your questions.

George Elston, our Consultant and Interim Chief Financial Officer; and Dario Paggiarino, Senior Vice President and Chief Medical Officer, will be available during the Q&A.

Earlier this morning, we issued a press release detailing the financial results as well as commercial and operational developments. A copy of the release can be found in the Investor Relations tab on the corporate website, www.eyepointpharma.com.

Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments and regulatory matters and time lines, the potential success of our product candidates, financial projections and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent annual report on Form 10-K, which is on file with the SEC and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligations to do so even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.

I will now turn the call over to Nancy Lurker, President and Chief Executive Officer of EyePoint.

--------------------------------------------------------------------------------

Nancy S. Lurker, EyePoint Pharmaceuticals, Inc. - President, CEO & Director [3]

--------------------------------------------------------------------------------

Thank you, Kimberly. Good morning, everyone, and thank you for joining us. I am encouraged by the progress that the EyePoint team made during the third quarter following the launches of our 2 commercial products, DEXYCU and YUTIQ. We are gaining momentum in the marketplace as physicians and ambulatory surgery center, or ASC, adoption increases, as evidenced by increased customer orders and repeat orders, new unique accounts being added and increased order size. These efforts are a direct result of the hard work and dedication of our key account manager sales team that continue to travel throughout the U.S. to bring our ophthalmic products to patients in need.

Although Q3 total revenues of $2.5 million were lower than the prior quarter driven, in part, by a strategic decision by our distributor to significantly reduce their carried inventory, we are very pleased with the underlying customer adoption we are seeing. Our product revenue is recognized under the title model when we ship product to our distributor and title transfers to them. This accounting mechanism does not necessarily reflect the underlying customer order activity, especially in the early phase of a product launch, and we plan to provide various metrics today to help listeners understand this process and get a better sense of the high degree of enthusiasm that we are seeing for these 2 products.

Let me begin with DEXYCU, or dexamethasone intraocular suspension 9% for the treatment of post-operative inflammation, including following cataract surgery. Please refer to Slide 6. While the DEXYCU selling process of training physicians and educating their associated ASC takes time, we have made significant progress, demonstrated by the important metric of customer demand. Customer orders for DEXYCU were up 207% over Q2, and September was our strongest month since launch, with more customer orders in September alone than in all of Q2.

Second, and importantly, 37% of all ASC orders placed in Q3 were repeat orders, accounting for 74% of total order volume through the end of the third quarter, with September representing the highest volume month for repeat orders to date. This shows that, once used, DEXYCU -- once DEXYCU is used, excuse me, doctors and ASCs are ordering more of it. We consistently hear about DEXYCU's strong efficacy and efficient administration.

Referring to Slide 7, which highlights our cumulative order growth since launch. You can see the order momentum increasing each month. DEXYCU month-over-month growth averaged 62.5% in the third quarter. Again, you can see how strong September was in this graph. The increase is being driven by greater adoption by physicians, coupled with a higher degree of confidence by individual ambulatory surgery centers relative to reimbursement. We are very pleased with these trends. Our sales force is doing a tremendous job thus far, and we are seeing signs of greater momentum early in the fourth quarter. Reimbursement of DEXYCU has been consistently positive based on the WAC price of $595. Medicare fee-for-service claims continued to be paid consistently, and Medicare Advantage and commercial paid claims increased quarter-over-quarter. Average time to payment for all payer sectors continues to decrease, and we expect this decrease to continue as payer systems incorporate the permanent DEXYCU J-code.

We believe that DEXYCU is emerging as a favored treatment for inflammation following ocular surgery. A number of you witnessed several live surgeries during our Surgery Day event held in September at a very busy surgical practice in the New York area. The lead surgeon there performed several cataract surgeries using both DEXYCU and alternative treatments. There was a clear advantage shown with DEXYCU, given its targeted administration and seamless integration into the cataract surgical procedure.

To demonstrate how efficient DEXYCU's insertion is, please take a look at this video on Slide 8. The patient's cataractous lens has already been removed and replaced with an intraocular lens. And you can see now, the surgeon's administering the cannula over the eye, and right now, just injected DEXYCU, which is peaking out from under behind the iris. You can see that little pearl there peaking out. You can see how quickly this is. There's no new insertion -- incision needed, and the surgeon is done.

Feedback from early adopters highlight DEXYCU's efficacy and rapid injection time of less than 1 minute, which does not materially impact a physician's surgery schedule. Recall, these are extremely busy surgeons who want to quickly move from surgery room to surgery room and try to complete each cataract surgery in 8 to 12 minutes. They usually do not want any new procedure to significantly slow them down. They are very pleased with the easy and rapid administration of DEXYCU.

DEXYCU remains in the eye for up to 22 days, delivering dexamethasone and providing critical dosing of anti -- of this anti-inflammatory medicine, ensuring patient compliance, and thus, obviating the need for steroid eye drops, all their complexity and simplifying their postoperative eye drop regimen by up to 1/3.

We urge you to view several other videos on our website, which highlights physician and patient experiences with DEXYCU. You can locate these videos on the corporate website in the Pipeline section at www.eyepointpharma.com.

Turning now to YUTIQ, or fluocinolone acetonide intravitreal implant 0.18 milligrams for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. We are making very positive inroads with physicians who recognize the need for long-acting treatment to control uveitic flares, which can lead to blindness if not properly managed.

Now please refer to Slide 10. During the third quarter, customer orders for YUTIQ increased 17% as compared to the second quarter. 53% of customers that ordered in the quarter were repeat customers, and their orders accounted for 85% of total order volume.

Cumulative orders since launch are also shown. On Slide 11, you can see YUTIQ month-over-month growth of cumulative orders for the quarter averaged at 22%. This increase is being driven by greater awareness and adoption of YUTIQ. We strongly believe we're only in the beginning of YUTIQ's growth trajectory as the physician and patient community becomes educated on how we address this very high unmet need.

I also thank our clinical team who continue to showcase YUTIQ's long-term efficacy and safety through a well-managed cadence of data publications and presentations at high-profile scientific conferences, most recently at the Retina Society and the American Academy of Ophthalmology Annual Meeting in very well-attended presentations.

The presentations concluded that treatment with YUTIQ not only resulted in a significant reduction in the 3-year rate of uveitic recurrences, but that YUTIQ also reduced the cumulative number of inflammatory episodes in eyes that did relapse. It also highlighted that a single intravitreal treatment of YUTIQ significantly reduced the need for adjunctive therapies in this group of patients, and the long-term effects on intraocular pressure were manageable and not different than a sham injection. These efforts provide additional continued support for YUTIQ's value for treating this terrible disease.

On the reimbursement front, Medicare fee-for-service claims have been paid consistently, and a growing number of Medicare Advantage and commercial payers are covering YUTIQ.

Also, and importantly, a permanent and specific J-code for YUTIQ is in effect as of October 1, 2019. This new code will expedite reimbursement claims paid to just a few weeks compared to up to 3 months with the miscellaneous code.

During the quarter, we did see YUTIQ customer demand slow in September as prescribers were very clear to us, they wanted to wait for the permanent J-code to go into effect to avoid the cumbersome reimbursement process with the prior miscellaneous J-code.

We are very pleased with the customer order trajectories for both products this quarter despite the disconnect with reported revenue under the title model. Given this complexity, customer orders and reported revenue will likely track separately for an extended period of time beyond initial launch as customer demand patterns may not align with the distributor inventory restocking procedures. We are evaluating the possibility of transitioning out of the title model, which would provide greater transparency.

Going forward, we intend to share customer metrics so you can gauge our product progress for DEXYCU and YUTIQ, 2 very exciting new treatment paradigms in ophthalmology.

Now I'm going to turn the call over to Scott Jones, Chief Commercial Officer, who will discuss some recent new contracts with integrated health networks that will broaden the reach of DEXYCU and YUTIQ as well as other sales and marketing initiatives that commenced during the quarter. Scott?

--------------------------------------------------------------------------------

David Scott Jones, EyePoint Pharmaceuticals, Inc. - Chief Commercial Officer [4]

--------------------------------------------------------------------------------

Thank you, Nancy. The efforts by our sales team to support the launches of our 2 commercial products, DEXYCU and YUTIQ, are showing progress as we're seeing increased awareness and adoption.

Let me begin with our activities for DEXYCU, and you can refer to Slide 13. During the third quarter, our team of 33 KAMs for DEXYCU called on over 8,000 medical professionals, including over 500 physicians. We've also had over 350 ambulatory surgery centers that have completed the training and certification process for DEXYCU. These efforts have resulted in an increase in the number of new accounts that have been activated, a shorter sales cycle and a shorter time to reorders and increasing numbers of units ordered by individual physicians. Our sales cycle begins with initial engagement with the target physicians where the KAM introduces DEXYCU and its compelling product profile as well as the positive efficacy and clinical safety data. From there, we educate the physicians, ASC staff and other key decision-makers within the ASC with the goal to drive to a commitment to a DEXYCU trial. Our team then schedules a DEXYCU trial utilizing samples with the intent to eventually certify the ASC on the proper administration of the product.

Billing education is also conducted with the ASC staff with the key focus on the straightforward J-code billing process. Once the first order is placed, ambulatory surgery centers typically wait to confirm reimbursement is in place before placing the next order and subsequently scheduling patients. Our KAM team provides ongoing surgical support throughout the reorder process. We have seen solid success in orders from our targeted core of high-volume physician-owned ASCs, typically in markets that have the largest population of Medicare beneficiaries and with the highest concentration of cataract surgeries. Further, our educational efforts targeted to the ASCs and the private equity firms that own many of these centers continue to highlight the value proposition that DEXYCU brings to both doctors and patients. The feedback that we have received has been very positive with physicians citing the elegant and rapid administration that fits well into the cataract procedure, allowing for no disruption in their busy surgery schedule.

We continue to optimize the sales cycle by expediting the training to increase adoption in orders. The time from the initial call by a sales rep to the first physician order has been trending at around 5 weeks. With reorders beginning to come in, we now see that this time frame has dropped to 3.9 weeks from the time of the first order to the second order. And if we further look at the time from the second order to the third order, that time is further reduced to 2.5 weeks. We expect the sales cycle to further compress as physicians offer DEXYCU as their choice treatment for post-surgical inflammation following cataract surgery and continue to place some more frequent and subsequent bulk orders.

Our communication about the J-code on DEXYCU has reduced concerns around reimbursement. And customers' level of comfort with the claim adjudication process continues to grow as claims are consistently paid.

Our efforts are yielding results as physicians have increased their unit orders and the sales momentum has been building monthly. Importantly, we are seeing that for most accounts, the number of units ordered have nearly doubled in the second order placed as compared to the initial order. And we're highly encouraged by the monthly increase in physician adoption. Based on internal data, we estimate the DEXYCU market opportunity of our targeted accounts to be valued at approximately $2.5 billion.

The ASCs, which, to date, have been in service and trained as part of our launch initiatives, would create a value of $120 million; with those ASCs that have reordered, bringing a value of about $97 million.

If you further look at just those accounts that have placed at least 3 or more orders, that is a market opportunity of about $28 million. So these figures highlight the great market growth potential of DEXYCU and reinforce the attractive market opportunity for this product.

Turning to YUTIQ. Demand remains strong, supported by our clinical data, which highlights safety and long-term durable efficacy up to 36 months. In an effort to support increasing interest in the market, we have recently added 2 additional territories to our YUTIQ team, and we'll soon have 12 KAMs in total calling on top uveitis specialists.

DEXYCU and YUTIQ have also gained acceptance in multiple integrated health networks, which is a positive harbinger for future growth, as highlighted on Slide 15. We recently entered into an interim agreement for DEXYCU and YUTIQ to be added to the U.S. Department of Veterans Affairs Federal Supply Schedule. This will extend the reach of our 2 products to 9-plus million beneficiaries within the VA system as well as select other federal agencies. The final contract is anticipated to be executed in the coming months and is expected to have a 5-year term.

In addition, we recently entered into a 3-year agreement with Vizient on -- for the DEXYCU brand, further expanding the reach of this product through some of the largest and most influential hospitals and surgery centers in the U.S. Vizient, for those of you that aren't aware, is one of the largest GPOs in the nation, includes more than 50% of the nation's acute care providers, including 95% of the nation's academic medical centers and more than 20% of ambulatory care providers. Vizient provides expertise, analytics, advisory services as well as the contract portfolio that represents more than $100 billion in annual purchasing volume, all with the concept of trying to improve patient outcomes and lower cost.

With these contracts in place, we have further increased the reach of our products to patients in need and expanded the -- and the expanded access should begin to be impactful in future quarters.

On the marketing side, we're actively expanding our peer-to-peer promotion, our social media presence, and we're hosting a number of roundtable discussions, which offer our key physicians an opportunity to share their patient experiences to queue into their protocols and also to talk about patient flow and importantly, patient outcomes.

Our goal is to expand EyePoint's reach into the medical community and increase physician interest in our products.

In summary, we believe that our initiatives are the right steps forward to support the future growth for DEXYCU and YUTIQ. Now let me turn the call back over to Nancy.

--------------------------------------------------------------------------------

Nancy S. Lurker, EyePoint Pharmaceuticals, Inc. - President, CEO & Director [5]

--------------------------------------------------------------------------------

Thanks, Scott. Moving now to an update on our pipeline on Slide 16. We continue to make progress with our 6-month duration YUTIQ product and expect to provide an sNDA update in the coming months. Our 6-month sustained release bio-erodible intravitreal insert, containing a tyrosine kinase inhibitor, or TKI, was investigated in preclinical efficacy and safety studies in animal models of wet AMD. Additional preclinical IND-enabling studies are planned for this year. We expect to advance this program into the clinic late next year, and are very excited about its potential in the attractive wet AMD market and possibly in other retina conditions requiring sustained and controlled anti-VEGF delivery.

In addition to assessing organic growth opportunities, we continue to evaluate and welcome business development opportunities to augment our product pipeline and also evaluate partnerships surrounding our Durasert and Verisome technologies.

Now I will review our -- the financial results that are included in the press release that was issued this morning. For the 3 months ended September 30, 2019, total revenue was $2.5 million compared to $486,000 for the 3 months ended September 30, 2018. Net product revenue was $1 million, representing primarily DEXYCU restocking by our distributor. Due to sufficient inventory stocking at our distributor, YUTIQ did not have any restocking revenues under the title model during the quarter. Neither product had net revenue in the corresponding quarter in 2018.

During the third quarter, our distributor notified us they are moving to reduce their carrying risk for new programs and will be migrating to a lower 7-day inventory level. This change resulted in limited restocking for our recently launched programs as our standing inventory was reduced substantially by customer orders from our sales efforts.

Net revenue from royalties and collaborations for the 3 months ended September 30, 2019, totaled $1.5 million compared to $486,000 in the corresponding quarter in 2018. This includes a $1 million milestone payment from Ocumension Therapeutics, triggered by their approval of their investigational new drug in China for a 3-year micro-insert containing 1.8 milligrams of fluocinolone acetonide using the Durasert technology. We market this under the brand name of YUTIQ in the United States. Ocumension intends to market it under their own brand name, but it essentially is YUTIQ.

Operating expenses for the 3 months ended September 30, 2019, increased to $16.6 million from $14 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services and cost of sales related to product revenue, partially offset by a decrease in research and development expense.

Nonoperating expense net for the 3 months ended September 30, 2019, totaled $1.6 million of net interest expense. Net loss for the 3 months ended September 30, 2019, was $15.6 million or $0.15 per share compared to a net loss of $33.1 million or $0.44 per share for the prior quarter. As of September 30, 2019, cash and cash equivalents totaled $31.8 million compared to $44.2 million as of June 30, 2019. There were approximately 108 million common shares outstanding as of September 30, 2019. We expect that existing cash and cash equivalents at September 30, 2019, and cash inflows from anticipated YUTIQ and DEXYCU product sales will be sufficient to fund our operating plan into 2020.

Given our 2 commercial product launches, we have not yet established a consistent sales trajectory, and therefore, guidance regarding the timing of positive cash flow and revenue is not being provided.

I will now turn the call back over to the operator for your questions. Operator?

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) And our first question comes from Dana Flanders with Guggenheim.

--------------------------------------------------------------------------------

Dana Carver Flanders, Guggenheim Securities, LLC, Research Division - Senior Analyst [2]

--------------------------------------------------------------------------------

My first here, can you just speak to the Vizient contract you signed, and I guess, the importance of that to driving DEXYCU growth next year and how you're thinking about signing up additional GPOs and other maybe nontraditional members to kind of drive reimbursement for DEXYCU? And then I have a quick follow-up.

--------------------------------------------------------------------------------

David Scott Jones, EyePoint Pharmaceuticals, Inc. - Chief Commercial Officer [3]

--------------------------------------------------------------------------------

Thank you for the question. Vizient is obviously a very important GPO contract for us. As I previously said, it opens up a significant portion of the acute care and ambulatory care markets. So we're very pleased with that. We -- again, we're just starting to see those contracts being loaded into the systems and customers being able to take advantage of a reduced price through the contract. So we think, in the coming quarters, we'll see additional benefits from that contract.

The second part of your question, as to other GPOs, there's certainly a few other GPOs that we're actively working on right now, which are much more specific to the chain ASC market that will be extremely important for us to pull-through early next year, and we are very actively working on those. And hopefully, we'll have more information in the coming quarters.

--------------------------------------------------------------------------------

Dana Carver Flanders, Guggenheim Securities, LLC, Research Division - Senior Analyst [4]

--------------------------------------------------------------------------------

Okay, great. And just my quick follow-up. At what point should we start to see underlying demand kind of more closely matching revenue?

--------------------------------------------------------------------------------

Nancy S. Lurker, EyePoint Pharmaceuticals, Inc. - President, CEO & Director [5]

--------------------------------------------------------------------------------

Dana, it's Nancy. Yes, I would say probably we need a couple more quarters until we start to see that -- those 2 trajectories merge.

--------------------------------------------------------------------------------

Operator [6]

--------------------------------------------------------------------------------

And our next question comes from Andrew D'Silva with B. Riley.

--------------------------------------------------------------------------------

Andrew Jacob D'Silva, B. Riley FBR, Inc., Research Division - Senior Analyst [7]

--------------------------------------------------------------------------------

I got just a few quick questions here. I'll start with the ones on YUTIQ. As far as end user demand and it will line up with the stocking orders, as you're looking out through Q4, do you anticipate the bolus that you had earlier in the year from stocking will be able to be worked through a little bit so that they might place another order? Or do you expect that we should consider that to be a 2020 event?

And then has there been any benefit from the whole Allergan OZURDEX shortage?

--------------------------------------------------------------------------------

Nancy S. Lurker, EyePoint Pharmaceuticals, Inc. - President, CEO & Director [8]

--------------------------------------------------------------------------------

So to your first question, the answer is definitely, we will see orders placed by our distributor or the title model in 4Q. So that inventory, as I mentioned on YUTIQ, has pretty much been worked all the way down. So we're pretty confident in -- we're very confident in terms of what we're seeing. And also, let me just stress, YUTIQ -- I just want to -- it's a fantastic product. And it meets a lot of high unmet need, and we are seeing very, very nice customer order momentum out in the field. Also because it just performs. And these patients don't want to keep having to come back in for multiple injections, particularly when they're scared to death, they're going to go blind.

So as to the question -- I'm sorry, your second -- Allergan and OZURDEX. I'm going to turn that over to Scott. He's closer out in the field in terms of the impact we're seeing with that.

--------------------------------------------------------------------------------

David Scott Jones, EyePoint Pharmaceuticals, Inc. - Chief Commercial Officer [9]

--------------------------------------------------------------------------------

Sure. Andy, to your second question, so we have not yet seen a pickup related specifically to that issue and for one reason. I think there was a lot of information in the community relative to a coming shortage, and physicians were able to stock up effectively. We do anticipate as they work through that stock that we will see additional trials with YUTIQ related to that issue, though.

--------------------------------------------------------------------------------

Andrew Jacob D'Silva, B. Riley FBR, Inc., Research Division - Senior Analyst [10]

--------------------------------------------------------------------------------

Okay, okay. And as it relates to that, you mentioned partnership. Are they running their own manufacturing process? Or is this being applied for the trials through your manufacturing and through your distribution channel?

--------------------------------------------------------------------------------

Nancy S. Lurker, EyePoint Pharmaceuticals, Inc. - President, CEO & Director [11]

--------------------------------------------------------------------------------

Yes. Yes, let me answer that question. So we are supplying it, and we have a supply agreement with them, and we will continue to supply finished product. They'll obviously package it under their own brand name. So that's how that works. We are not transferring our technology over to Ocumension in China.

Second of all, let me just mention, and this wasn't in some of the earlier press release, but just to remind the audience, the way this works is, in China, there are special need zones that are allowed where you can begin to use either European or U.S. NDA-approved drugs under a special needs area of the country.

YUTIQ or Durasert with fluocinolone has already been approved for that, and is actually currently being used now, albeit it just started, in commercial use for those types of patients. In parallel, Ocumension is running a clinical trial to get broader Chinese regulatory approval to launch this across the entire Chinese economy.

--------------------------------------------------------------------------------

Andrew Jacob D'Silva, B. Riley FBR, Inc., Research Division - Senior Analyst [12]

--------------------------------------------------------------------------------

Okay. Okay, that makes sense. And then last couple of questions just related to DEXYCU. So as far as ASCs go, are they starting to feel, in your opinion, just more comfortable with the billing process now that they've had a couple of quarters of leasing the product in the market and not having any issues?

And then just as we think about it from 30,000 foot view, it seems like ASCs are getting rolled up by private equity more and more. Does that change anything from a marketing standpoint or how you think about the space in general?

--------------------------------------------------------------------------------

David Scott Jones, EyePoint Pharmaceuticals, Inc. - Chief Commercial Officer [13]

--------------------------------------------------------------------------------

Both great questions. So on the first, relative to billing, we're certainly seeing an increased confidence level, especially as it relates to the Medicare Part B population. We're seeing more and more of our accounts kind of open up the gates to that population. It's still taking an extended period of time in -- with certain payers on the commercial side and on the Medicare Advantage side, so accounts are being a little more cautious there. But again, as we're continuing to see more payers add DEXYCU from a policy perspective and a payment perspective, we're starting to see the work and the efforts that we're putting in there increase the utilization on that side as well. But certainly, the confidence level is high on the Medicare population.

As to your second point on the private equity, the market has certainly changed significantly in the last 2 to 3 years. Private equity now accounts for probably over 25% of the marketplace, and then another 50% is owned by the chain ASCs, the HCAs, et cetera, of the world. And so within those 2 market segments, which very much control the activities of the individual ambulatory surgery centers, there's much more controls, which requires us to bring a different type of value proposition. We're certainly really working hand in hand with a number of private equity companies today to understand exactly what the value proposition is that we can provide and exactly what it is that they're evaluating in terms of new products.

The one common thing that we're hearing today is they really want to mitigate the risk. And so we're looking to partner with those companies to make sure that we can help mitigate the risk around DEXYCU.

--------------------------------------------------------------------------------

Andrew Jacob D'Silva, B. Riley FBR, Inc., Research Division - Senior Analyst [14]

--------------------------------------------------------------------------------

Okay, okay, got you. And just -- I'll put my last 2 questions together here. Basically, as we start thinking about drops as a pain point in general, are you seeing any just headwinds related to using DEXYCU because patients typically will still have to use drops for the antibiotic and NSAID? Or is that really just a nonevent?

And then you were referencing using other payers outside of Medicare Part B pass-through status. Has the Medicare Part B pricing floor been maintained when you're being reimbursed through outside payers?

--------------------------------------------------------------------------------

David Scott Jones, EyePoint Pharmaceuticals, Inc. - Chief Commercial Officer [15]

--------------------------------------------------------------------------------

So on to the first question relating to dropless therapies. We're certainly seeing an increase in the utilization of dropless therapies in the market simply because any opportunity to get away even from 1 drop is a huge advantage to the patient.

And if you think about the #1 complaint of patients post-cataract surgery, it is remembering the number of drops, the timing of the drops. And so anything that can be done to reduce that burden on patients, which ultimately becomes a burden on physicians, is seen as a positive in the marketplace.

As to your second question, we are seeing an expansion of the coverage of DEXYCU into the Medicare Advantage space and into the typical commercial space as well. The -- I think for the most part, plans are covering DEXYCU today based on just it's billed as -- because we have a permanent J-code, it makes the billing much more simple and a streamlined process. Payment rates seem to be fairly similar across all commercial lines. But again, we're certainly working with individual plans as well as with the ASCs to make sure that everyone is very comfortable with the coding coverage and payment before and during the process.

--------------------------------------------------------------------------------

Operator [16]

--------------------------------------------------------------------------------

And our next question comes from Yi Chen with H.C. Wainwright.

--------------------------------------------------------------------------------

Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [17]

--------------------------------------------------------------------------------

This is Edward Marks on for Ram. I appreciate you taking the questions. Just 3 quick ones for me. First off, how many ambulatory surgical centers have formally adopted DEXYCU? And how do you -- how many would have adopted it, do you think, by the end of 2019?

--------------------------------------------------------------------------------

David Scott Jones, EyePoint Pharmaceuticals, Inc. - Chief Commercial Officer [18]

--------------------------------------------------------------------------------

So as I mentioned earlier in the presentation, we have over 350 that have been trained and certified today. We're continuing to bring on about 25 new accounts per month. And so we continue -- we expect to continue to see that throughout the remainder of the year.

--------------------------------------------------------------------------------

Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [19]

--------------------------------------------------------------------------------

Okay. And you touched on this a little bit, but are the recently announced commercial agreements going to drive market penetration, do you think, more in the fourth quarter? Or do you think it's likely going to be a 2020 story?

--------------------------------------------------------------------------------

David Scott Jones, EyePoint Pharmaceuticals, Inc. - Chief Commercial Officer [20]

--------------------------------------------------------------------------------

We expect to see some pickup in the fourth quarter, but I think largely, this is a 2020 story.

--------------------------------------------------------------------------------

Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [21]

--------------------------------------------------------------------------------

Okay. And then just a final one for me. Has the FDA indicated that an NDA for the shorter-term version of YUTIQ can be submitted without the additional clinical trials? And if not, then when do you expect to obtain any clarity on that?

--------------------------------------------------------------------------------

Nancy S. Lurker, EyePoint Pharmaceuticals, Inc. - President, CEO & Director [22]

--------------------------------------------------------------------------------

Yes, let me answer that question, which is we don't get into any discussions publicly around our discussions with the FDA. So I'm going to hold off on that question. And as I said in my prepared remarks, we fully expect to update everybody before the end of the year on the sNDA for YUTIQ.

--------------------------------------------------------------------------------

Operator [23]

--------------------------------------------------------------------------------

And I'm not showing any further questions at this time. I will now turn the call over to CEO, Nancy Lurker, for any further remarks.

--------------------------------------------------------------------------------

Nancy S. Lurker, EyePoint Pharmaceuticals, Inc. - President, CEO & Director [24]

--------------------------------------------------------------------------------

Thank you, everyone, for your time today and for the very good questions. We look forward to keeping you updated on our commercial launch progress as well as other business matters in the coming quarters. And we're going to continue to work hard to make these products a new standard of care for both indications because we believe passionately in them.

Thank you, and we appreciate your continued support.

--------------------------------------------------------------------------------

Operator [25]

--------------------------------------------------------------------------------

Ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect.