Earnings Labs

EyePoint Pharmaceuticals, Inc. (EYPT)

Q3 2019 Earnings Call· Fri, Nov 8, 2019

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Transcript

Operator

Operator

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. There will be a question-and-answer session to follow at the completion of the prepared remarks. 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

Management

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 in our commercial launches, as well as highlight recent corporate developments and detail the third quarter 2019 financial results. We'll then open up the call for your questions.George Elston, our Consultant and Interim Chief Financial Officer and Dario Paggiarino, Senior Vice President & 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 obligation 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'll now turn the call over to Nancy Lurker, President and Chief Executive Officer of EyePoint.

Nancy Lurker

Management

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 two commercial products; DEXYCU and YUTIQ.We are gaining momentum in the marketplace as physicians and Ambulatory Surgery Center or AFC 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 renew is recognized under the title model where 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 stage of our 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 two products.Let me begin with DEXYCU or dexamethasone intraocular suspension 9% for the treatment of postoperative inflammation, and 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…

Scott Jones

Management

Thank you, Nancy. The efforts by our sales team to support the launches of our two 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 camps 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 increase in a number of new accounts that have been activated, a shorter sale cycle and a shorter time to reorders and increasing numbers of units ordered by individual physicians.Our sale cycle begins with initial engagement with the target physicians where the camp introduces DEXYCU is -- 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 DEXYCU trial.Our team then schedules the 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 place and before surgery, centers typically wait to confirm reimbursement is in place before placing the next order and subsequently scheduling patients. Our camp team provides ongoing surgical support throughout the reorder process. We have seen solid success in orders from our targeted core high volume physician on 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…

Nancy Lurker

Management

Thanks, Scott. Moving now to an update on our pipeline on Slide 16. We continue to make progress with our six month duration YUTIQ product and expect to provide an sNDA update in the coming months. Our six months sustained release bio-erodible intravitreal insert continue to Tyrosine Kinase Inhibitor or TKI was investigating and 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 and 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 financial results that are included in the press release that was issued this morning. For the three months ended September 30, 2019, total revenue was $2.5 million compared to $486,000 for the three months ended September 30, 2018. Net product revenue with $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 models 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 we will be migrating to a lower seven-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 three months ended September 30, 2019 totaled $1.5 million,…

Operator

Operator

[Operator Instructions] And our first question comes from Dana Flanders with Guggenheim. Please proceed with your question.

Dana Flanders

Analyst

Hi. Thank you very much for the questions. 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 GPO and other maybe non-traditional members to kind of drive reimbursement for DEXYCU? And then I have a quick follow-up.

Scott Jones

Management

Thank you for the question. So 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. Again, we're just starting to see those contracts being loaded into the systems and customers being able to take advantage of the 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're 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're very actively working on those and hopefully we'll have more information in the coming quarters.

Dana Flanders

Analyst

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

Nancy Lurker

Management

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

Dana Flanders

Analyst

Okay, great. Thank you.

Nancy Lurker

Management

Thank you.

Operator

Operator

Thank you. And our next question comes from Andrew D’Silva with B. Riley. Please proceed with your question.

Nancy Lurker

Management

Hi, Andy. Andrew D’Silva: Good morning. Thanks for…

Nancy Lurker

Management

Good morning. Andrew D’Silva: Hey, good morning. Thanks for taking my call. I got just a few quick questions here. I'll start with ones on YUTIQ, as far as end user demand and it will align up with stocking orders and looking out through Q4, do you anticipate the bolus that you had earlier in the year from a stocking or will be able to be worked with 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 and OZURDEX shortage?

Nancy Lurker

Management

So to your the first question is 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 -- we're very confident in terms of what we're seeing. And also, let me just dress, YUTIQ, I just want to say, it is a fantastic product. And it means 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 or going to go blind. So ask the question, I'm sorry, the 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.

Scott Jones

Management

Sure. Andrew, 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 company 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 D’Silva: Okay. Okay. Thanks for the color and as it relates to that you mentioned partnership. Are they running their own manufacturing process? Or is this sort of being applied for the trials through your manufacturing and through your distribution channel?

Nancy Lurker

Management

Yeah. Yeah, 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 tech transfer in our technology over documentation in China. Second of all, let me just mention and this wasn't some of the earlier press release, but just to remind the audience the way this works is. In China, there are special needs zones that are allowed where you can begin to use either European or U.S. NDA approved drugs under special needs area of the country YUTIQ or DEXYCU sent alone has already been approved for that and is actually currently being used now. I'll bet it just started in commercial use for those types of patients. In parallel automation is running a clinical trial to get broader Chinese regulatory approval to launch this across the entire Chinese economy. Andrew D’Silva: Okay, okay, that makes sense. Thank you. And then last couple questions just related to DEXYCU so as far as ASC go, are they're starting to feel, in your opinion more comfortable with the billing process now that they've had a couple quarters of leasing the product to the market and not having any issues? And then just as we think about it from, you know, 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 this space in general?

Scott Jones

Management

Both great questions. So on the first relative to billing, we're certainly seeing an increase confidence level, especially as it relates to the Medicare part the population, we're seeing more and more of our accounts, you know, kind of open up the gates to that population. It's still taking an extended period of time in certain – with certain players on the commercial side and on the Medicare Advantage side, so accounts are being a little more cautious there. Again, as we're continuing to see more payers add execute to from a policy perspective and a payment perspective. We're starting to see the work that and the efforts that were putting in there to increase the utilization on that side as well. But certainly, the confidence levels high on the Medicare population.As to your second point on the private equity, the market has certainly changed significantly in the last two to three years. Private Equity now accounts for probably over 25% of the marketplace. And then another 50% is owned by the chain ASC – HCA is et cetera of the world. And so within those two 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 we can provide an exactly what it is that they're evaluating in terms of new products. The one common thing that we're hearing today is they're 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 D’Silva: Okay, okay, got you. And just my last two questions together here. Basically as we start thinking about drops as a pain point in general, are you seeing any headwinds related to using DEXYCU? Because patients typically will still have to use drops for the antibiotic [Indiscernible] or is that really just a non-event?And then you were referencing using other payers outside of Medicare Part B pass-through status, has the Medicare Part B private floor been maintained when you're being reimbursed through outside payers?

Scott Jones

Management

So, onto the first question relating to drop of therapies, we're certainly seeing an increase in the utilization of drop of therapies in the market, simply because any opportunity to get away even from one drop is a huge advantage to the patient.And if you think about the number one 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 the 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 build 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 ASC's to make sure that everyone is very comfortable with the coding coverage and payment before and during the process. Andrew D’Silva: Okay, great. Thank you very much. I'll take everything else offline.

Operator

Operator

Thank you. And our next question comes from Yi Chen with H.C. Wainwright. Please proceed with your question.

Edward Marks

Analyst · H.C. Wainwright. Please proceed with your question.

Good morning. This is Edward Marks on forum [ph]. I appreciate you taking the questions. Just three quick ones from me. First off how many ambulatory surgical centers have formally adopted DEXYCU? And how do you -- how many would have adopted do you think by the end of 2019?

Scott Jones

Management

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 Marks

Analyst · H.C. Wainwright. Please proceed with your question.

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?

Scott Jones

Management

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

Edward Marks

Analyst · H.C. Wainwright. Please proceed with your question.

Okay. And then just the final one for me, has the FDA indicated that sNDA for the shorter term version of ET can be submitted without the additional clinical trials? And if not, then when do you expect it to obtain, any clarity on that?

Nancy Lurker

Management

Yeah, 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 you too.

Edward Marks

Analyst · H.C. Wainwright. Please proceed with your question.

Right, okay. That’s all for me. Thanks, I appreciate you taking the questions.

Nancy Lurker

Management

Thank you.

Operator

Operator

Thank you. 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 Lurker

Management

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, the new standard of care for both indications because we believe passionately in them. Thank you and we appreciate your continued support.

Operator

Operator

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