Good morning. My name is Sarah and I’ll be your conference operator today. At this time, I would like to welcome everyone to the EyePoint Pharmaceuticals Fourth Quarter and Full Year 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. I would now like to turn the call over to George Elston, Chief Financial Officer and Head of Corporate Development of EyePoint Pharmaceuticals. Sir, you may begin..

Thank you, Sarah, and thank you all for joining us on today’s conference call to discuss EyePoint Pharmaceuticals fourth quarter and full year 2019 financial results and recent corporate developments. With me today is Nancy Lurker, EyePoint’s President and Chief Executive Officer; and Scott Jones, our Chief Commercial Officer.

Nancy will provide a corporate overview as well as highlight recent pipeline developments and Scott will comment on recent progress made on our commercial launches. I will provide commentary on the fourth quarter and full year financial results after those updates and we will then open the call for your questions where we will be joined by Dr.

Dario Paggiarino, Senior Vice President and Chief Medical Officer. Earlier this morning, we issued a press release detailing our financial results as well as commercial and operational developments. A copy of the release can be found in the Investor Relations tab on the company 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 those 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, our President and Chief Executive Officer..

Thank you, George. Good morning, everyone, and thank you for joining us. 2019 would be a year of significant progress and achievement for EyePoint, marked by our transition into a commercial stage pharmaceutical company, focused and delivering innovative ophthalmic products to patients in need. We began 2019 with quarter one U.S.

commercial launches of DEXYCU for the treatment of postoperative inflammation following ocular surgery and YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

Our 45-person sales team of key account managers or KAMs led by our Chief Commercial Officer, Scott Jones, introduced and educated ambulatory surgical centers or ASCs and surgeons on DEXYCU and uveitis specialists on YUTIQ.

Through our cohesive efforts, we ended the year with $20 million in total revenues including $16.8 million in product revenue, $4.8 million for DEXYCU and $12 million for YUTIQ. We expect there will continue to be some disparity between reported 2020 quarterly revenues and underlying customer demand as new distributors adjust their inventory levels.

However, we do expect these metrics to track more closely as 2020 progresses. Our underlying customer demand remains strong and we were very pleased to see continued demand growth for both DEXYCU and YUTIQ with increases of 111% for DEXYCU and 59% for YUTIQ as compared to the third quarter of 2019.

Now in parallel with our commercial initiatives, we’ve advanced our very exciting ophthalmology pipeline and prioritized EYP-1901 and anti-VEGF tyrosine kinase inhibitor, otherwise known as TKI, six months sustained release potential therapy using our bioerodible Durasert technology.

EYP-1901 is being developed for wet age-related macular degeneration or wet AMD, diabetic retinopathy or DR and retinal vein occlusion or RVO. We have also clarified the clinical and regulatory pathway for YUTIQ 50, our short-acting six-month treatment for chronic non-infectious uveitis affecting the posterior segment of the eye.

I will provide more color and upcoming development plans for these programs a little later during this call. I’m now going to turn the call over to Scott Jones, our Chief Commercial Officer to review in more detail our commercial performance..

Thank you, Nancy. Let me first begin with an update on the DEXYCU launch. During the fourth quarter, our focus remained on both training physicians and educating their ASCs on DEXYCU to promote both initial orders and reordering.

Physicians continue to respond positively to the quick and easy administration of DEXYCU and its ability to control inflammation for up to 30 days post surgery.

The rapid injection of DEXYCU at the end of the cataract surgery, it helps keep physicians on track with their busy surgery schedule and sends patients home with an important anti-inflammatory treatment in place, which reduces the complexity of the postsurgical steroid eye drop regimens.

Since the launch, our team of 33 KAMs for DEXYCU have called on over 640 physicians, which has yielded approximately 440 ASCs that have completed training and certification for DEXYCU use.

We’ve seen very strong reception and orders from our targeted core of high-volume physician-owned ASCs in the markets that have the largest population of Medicare beneficiaries and with the highest concentration of cataract surgeries.

We’re also continuing to work to educate private equity owned ASCs on the advantages of DEXYCU and the streamlined reimbursement with the processing of our assigned J-Code.

Based on our internal data, we estimate that ASCs have been in service and trained today as part of our launch initiatives represent $170 million market opportunity and physicians that have continued to reorder represent $105 million market potential.

To put that in context, the overall cataract surgery market potentials estimated at $2 billion which highlights the great potential DEXYCU and that attractive market opportunity for this product.

It’s important to note though that changing a treatment technology like we’re trying to do with DEXYCU moving from post-surgical eye drops, which are patient administered and distributed through retail pharmacy chains to an end of the surgery administration and a buy and bill distribution through the ASC.

It takes time to complete, but we remain very confident in DEXYCU’s potential given its excellent efficacy and safety profile, which is now being demonstrated in the real world and its administration by physicians, allowing them to take control of a critical element of postocular surgery, treating the post-surgical ocular inflammation.

One of our key priorities has been to expedite the training process in order to increase ASC adoption and orders. And we’re seeing that the timing between the first and second orders continues to decrease quarter-over-quarter.

Importantly, we’re still seeing that for most accounts, the number of units ordered have nearly doubled in the second order place as compared to the initial order. As Nancy noted earlier, customer demand represented by the units purchased by ASCs from our distributors was up 111% over Q3 with repeat customers representing 98% of the Q4 order volume.

And December alone represented our strongest month for orders during our launch today. Since launch, over 14,000 patients have been injected with DEXYCU. Reimbursement of DEXYCU has been consistently positive based on our WAC price of $595.

Medicare fee-for-service claims continued to be paid consistently, and Medicare Advantage and commercial paid claims have increased quarter-over-quarter. ASCs are gaining more confidence each day to this reimbursement process, which eventually translates the increase orders once this barrier has been lifted.

Another key priority area in our launch has been to secure additional access and purchase agreements with both the integrated health networks and also other vendors and ASCs continued to show adoption based on this.

Our recent agreement with The Vision Center Network of America and EyeSouth Partners, which collectively performed approximately 115,000 cataract surgeries per year exemplifies this progress. We hope to continue this trend in 2020 and we’re actively negotiating agreements with additional group purchasing organizations and networks.

The strong DEXYCU product profile continues to receive positive reception and recognition from the KOL community. Positive retrospective case study data of DEXYCU were presented at the 2020 Caribbean Eye Meeting this January.

These interim results presented are from 154 patients administered with DEXYCU and showed the proportion of patients with complete anterior chamber cell clearing, which is a key measure of inflammation, was 84.1% at postoperative day 14 and 87.5% at postoperative days 30.

These are very good results, and the real-world results as opposed to controlled clinical trial data and they provide additional support for our belief in the therapeutic potential of DEXYCU and its ability to improve patient compliance for treating postocular surgical or surgery inflammation.

Now turning to YUTIQ, we continue to receive very strong adoption with uveitis specialists that share our excitement for YUTIQ as a highly differentiated treatment option compared to existing therapies due to its ability to deliver a consistent, sustained 24-hour micro dose of steroids every day for up to three years.

This is remarkable when you think about it, especially for the posterior segment uveitis which often flares unpredictably and these flares can lead to blindness.

In addition, YUTIQ is delivered as a convenient single administration in the physician’s office and physicians are regularly provide feedback on need for a long acting treatments for non-infectious uveitis affecting the posterior segment of the eye to control these uveitis flares. And as a result, YUTIQ feels a very critical unmet medical need.

YUTIQ is durable 36-month efficacy clinical data and positive safety profile have been well received within the ophthalmology community has already built a very strong buzz among physicians and patients.

As we shared earlier this week, our 36-month top line results from the second Phase 3 study of YUTIQ showed the same durable responses, the first study with a recurrence rate of 46.5% compared to 75% of sham eyes with a P value equal to 0.001. This is an approximately 40% reduction in patients who suffer from even one flare over three years.

The visual acuity gains or losses of three lines or more were both similar between patient groups. Even though sham patients had to be rescued with interim periocular therapies at a much higher rate of 51.9% versus only 8.9% for YUTIQ.

The safety data showed no unanticipated side effects that each follow-up time point at 12 months, 24 months, and 36 months. These results provide additional validation of YUTIQ’s ability to reduce flares and control inflammation in patients who suffer from this devastating disease.

During the fourth quarter, customer demand represented again by units purchase by physicians from our distributors, increased by 59% as compared to the third quarter. 87% of customers that ordered during the quarter were repeat customers and their orders accounted for 98% of the total order volume.

Cumulative orders since launch have increased month over month and we hope to continue this growth trajectory in 2020. As a result of this very positive demand for the product, we expect to add to the existing 12 KAMs covering YUTIQ during 2020 to better grow our coverage in the U.S.

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 the product.

The permanent specific J-code for YUTIQ was effective as of October 1t of 2019 and it expedites the reimbursement claims pay to just a few weeks compared to up to three months.

Recall that we did see customer demand slow toward the end of the third quarters prescribers waited for the J-code to go into effect to avoid the cumbersome reimbursement process that occurred when using the prior miscellaneous J-code.

We have to extend the growing momentum seeing in the fourth quarter throughout 2020, but we recognize that we have plenty of work and education left to do for both products. We believe in 2019, we laid the foundation for both products and we’re now focused on accelerating the revenue growth.

For DEXYCU, we’re truly introducing a technology shift for these patients and for physicians and the ASCs where they practice. Our expansion activities will continue to focus on securing additional volume based agreements with ASCs and integrated health networks to expand access for patients.

For both products, we remain focused on continued target account penetration and increased educational activities with key opinion leaders at the major ophthalmology medical meetings.

As Nancy mentioned in our opening comments in the fourth quarter, we moved from a single distributor title model to a traditional network of specialty distributors, which is much more common in our industry. And we hope that this model will better align our reported product revenues and customer demand.

They will likely trap separately for some period during 2020. It is also important to note that during the first calendar quarter, fewer treatments are typically performed both in surgical and drug-related therapeutics. And I think that’s especially true of ophthalmology.

This is especially noticed where you have larger co-insurances and copays are required due to insurance plans resetting at the beginning of each calendar year. With that, I’ll now turn it back over to Nancy..

Thank you, Scott. Let me now move to our pipeline programs including our lead development product candidate EYP-1901, an anti-VEGF tyrosine kinase inhibitor, six-month sustained release potential therapy using our bioerodible Durasert technology for wet AMD, RVO, and DR.

We’re very excited about this program as it has the potential to provide a disruptive six-month sustained delivery product to the wet AMD market and potentially other indications. Using our proven Durasert technology, coupled with vorolanib, an anti-VEGF small molecule.

Vorolanib as a TKI has already established efficacy signals from two prior human studies in wet AMD as an orally delivered therapy.

In February, we announced an exclusive license agreement with Equinox Science for vorolanib for an upfront payment of $1 million, future developmental and regulatory milestones and single digit post commercialization royalties.

Although the agreement was recently announced, we have been actively working with vorolanib for over a year and completed the license after establishing initial activity in a classic animal model of wet AMD and evaluating ocular safety and PK for EYP-1901, the combination of which is bioerodible Durasert and anti-VEGF vorolanib.

The prospects for EYP-1901 are very compelling based on several important factors. First and very importantly is that the Durasert delivery technology has been used in multiple FDA approved products and has demonstrated its safety in thousands of patients. This includes Retisert, ILUVIEN and YUTIQ.

The Durasert bioerodible intravitreal insert used in EYP-1901 has no new excipients, and therefore, we expect to see the same safety profile as our non-erodible Durasert. Over the years, many promising ocular drug delivery technologies have failed due to safety issues that materialize in the clinic with the delivery technologies.

We believe the Durasert regulatory history and clinical history is a critically important differentiator for EYP-1901 and that it could substantially reduce the risk of this development program.

Second, vorolanib, the anti-VEGF active compound and EYP-1901 has been evaluated already in separate Phase 1 and Phase 2 human trials as an oral therapy for wet AMD. And it reported positive efficacy signals including improved best corrected visual acuity, a decrease in rescue anti-VEGF injections, and a reduction in central retinal thickness.

Consequently, EYP-1901 is advancing towards the clinic with both a proven drug delivery technology in Durasert and an active drug vorolanib that brings an efficacy signal in wet AMD as an oral therapy.

We believe that delivery vorolanib locally in the eye as EYP-1901 as a six-month sustained delivery potential intravitreal treatment will equal or even improve results observed for the oral delivery of vorolanib without the toxicities associated with the oral anti-VEGF treatments.

In our initial animal studies of EYP-1901, promising activity was demonstrated in an established CNV laser animal model of human wet AMD and preliminary ocular and systemic safety was observed in initial PK and non-GLP toxicology two-month studies.

In these nonclinical studies EYP-1901 and vorolanib was measured in the retina at concentrations well above the IC50 levels which is the half maximal inhibitory concentration and as a measure of drug potency. We’ve been very busy.

We also recently completed a positive Type B pre-Investigational New Drug meeting with the FDA in January and have a clear pathway to begin Phase 1 clinical development of EYP-1901.

GLP toxicology studies are expected to begin this month, and if positive, we plan to file an IND in the fourth quarter of this year allowing the initiation of a Phase 1 study that can potentially provide data readouts as early as the second half of 2021.

Finally and equally important EYP-1901 is potentially disruptive and beneficial product option for patients and physicians in established attractive multibillion dollar retinal disease markets.

Wet AMD, diabetic retinopathy and retinal vein occlusion are most commonly treated with intravitreal injections of biologics that block VEGF, which is a growth factor that plays a central role in the abnormal retinal blood vessel growth and leakage leading to disease recurrence.

FDA approved biologic treatments for these diseases are injected into the eye as frequently as monthly, but in real world outcomes, patients typically receive fewer injections leading to progressive visual acuity loss. It’s tough to get your eye injected monthly or bimonthly for the rest of your life.

Thus, it’s become increasingly urgent to get to these patients effective anti-VEGF treatment that do not require these often scary and unpleasant monthly or bimonthly eye injections. Finally and not to be minimized is the consistent 24/7 micro dosing of drug that EYP-1901 we expect will deliver for up to six months.

In addition to the potential risk directly associated with frequent intravitreal injection procedures such as ocular infections.

It’s not healthy for the eye to receive a monthly or bimonthly bolus eye injection which causes a seesaw drug concentration and theoretically can result in the VEGF receptors to down regulate over time and slowly stop responding.

We anticipate that there is real potential for an improved treatment effect by having consistent drug delivery over six months using EYP-1901. We expect these markets to continue to grow with the aging U.S.

population and the pressing need for treatment to replace the current available biologics with fewer injections and sustained delivery of anti-VEGF therapy. EYP-1901 represents a promising and potentially game changing potential six months sustained microdosing release and an exciting treatment option for these patients.

EYP-1901 is a complementary fit to our ophthalmology pipeline and aligns with our greater strategy of targeting areas of highly significant unmet medical needs in the ocular disease space. We look forward to providing updates on this potentially transformative program throughout the year. Late in 2019, we also receive clarification from the U.S.

Food and Drug Administration or FDA on the regulatory pathway to approval for YUTIQ 50. The FDA is requiring an approximately 60-patient six-month trial for inclusion in a supplemental new drug application for the product.

We are actively planning the trial and prioritizing resources and investment requirements and look to provide updates on timing later this year.

On the corporate front, we recently expanded our partnership with Ocumension Therapeutics with the signing of a second licensing agreement for the development and commercialization of DEXYCU in mainland China, Hong Kong, Macau, and Taiwan. We maintain worldwide development and commercialization rights outside of the territories license to Ocumension.

Under the terms of the agreement, we received an upfront payment of $2 million and are eligible to receive up to an additional $12 million if certain future pre-specified development, regulatory and commercial sales milestones are achieved by Ocumension as well as royalties on their product sales.

We are delighted to grow this partnership and bring DEXYCU to additional patients in need in China. In November, we also appointed George Elston as our Chief Financial Officer and Head of Corporate Development.

George brings a wealth of experience as a senior executive of such biopharmaceutical companies like Enzyvant Therapeutics, 2X Oncology, Juniper Pharmaceuticals and KBI Biopharma. I’m now going to turn the call over to George to review the financials..

Thank you, Nancy. I joined EyePoint in November, because I truly believe in our mission to change the treatment paradigm for patients suffering with ocular diseases and I believe we have the right team and the right pipeline to achieve this goal. I’ll now turn over to the financial results included in the press release that was issued this morning.

For the three months ended December 31, 2019, total revenue was $8.6 million compared to $2.4 million in the correspondent quarter in 2018. Net product revenue was $7.9 million, with $4.8 million for YUTIQ and $3.1 million for DEXYCU. Neither of these products have net product revenue in the corresponding quarter in 2018.

Net revenue from licenses, royalties and collaborations for the three months ended December 31, 2019, totaled $750,000 compared to $2.4 million in the corresponding quarter in 2018. The prior year quarter has a recognition of $1.7 million from an up-front licensing fee to Ocumension for YUTIQ.

Operating expenses for the three months ended December 31, 2019, increased to $17.6 million from $13.4 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, and cost of sales related to product revenue.

Non-operating expense, net, for the three months ended December 31, 2019 totaled $1.4 million of net interest expense. Net loss for the three months ended December 31, 2019, was $10.4 million, or $0.10 per share, compared to a net loss of $11.6 million, or $0.12 per share, for the prior year quarter.

For the full year ended December 31, 2019, total revenue was $20.4 million compared to $4.6 million in the corresponding period in 2018. Net product revenue was $16.8 million, with $12 million for YUTIQ and $4.8 million for DEXYCU. Neither of these products had net product revenue in the correspondent year 2018.

Net revenue from licenses, royalties and collaborations for the full year ended December 31, 2019 totaled $3.5 million compared to $4.6 million in the corresponding period in 2018.

Operating expenses for the full year ended December 31, 2019, increased to $68.2 million from $43.6 million in the prior year period, due primarily to investments in our sales and marketing infrastructure and program costs, increase in personnel expenses related to senior management additions and the full year impact of prior additions, and cost of sales related to product revenue, partially offset by a decrease in research and development expense.

Non-operating expense, net, for the full year ended December 31, 2019, totaled $8.9 million and consisted of $5.1 million of net interest expense and $3.8 million from the loss on extinguishment of debt related to the payoff of the SWK term loan.

Net loss for the full year ended December 31, 2019, was $56.8 million, or $0.54 per share, compared to a net loss of $86.1 million, or $1.27 per share, for the prior year period. Cash and cash equivalents at December 31, 2019, totaled $22.2 million compared to $31.8 million at September 30, 2019.

In February 2020, we completed an underwritten public offering of 15 million shares of common stock at a public offering price of $1.45 per share. The gross proceeds of this offering or $21.8 million, before deducting the underwriting discounts and commissions and other transaction expenses.

In addition, underwriters were granted a 30-day option to purchase up to an additional 2.3 million shares of common stock at the public offering price, less underwriting discounts and commissions.

We expect that our cash and cash equivalents combined with the February 2020 underwritten public offerings, proceeds and projected cash inflows from anticipated YUTIQ and DEXYCU product sales should fund the company’s operating plan into 2021. We will now turn the call over to the operator for questions..

Thank you. [Operator Instructions] Your first question comes from the line of Dana Flanders from Guggenheim Securities. You may ask the question..

Hi, thank you very much for the questions. My first one here, can you just elaborate a little bit more on your TKI? I know there are some data out there in the public domain, but just a little bit more on the efficacy that you have seen in prior studies and why that has you excited to move forward with this in into Phase 1.

And then my second one on the TKI, just any early thoughts on how big the Phase 1 will be that you plan to run later this year?.

So I'm going to address at a high level and then I'll have Dr. Dario Paggiarino go into a bit more detail for you on that Dana. So first of all, vorolanib went through a Phase 2 human study. So Phase 1, which is published and Phase 2. And in both cases showed efficacy in wet AMD. Dario can go into the specifics.

It did stop prematurely in Phase 2 due to well-known tyrosine kinase inhibitor, orally delivered systemic side effects, which again are usually typical that you see with TKIs when delivered orally, which has to do with liver enzyme elevation and some GI issues.

Again, we expect that we're able to deliver this in the eye locally that you should not see the systemic liver enzyme or other systemic side effects that you see with much higher oral or orally delivered doses.

The second to your point about Phase 1 and then Dario, will come back and address a little bit more detail some of the efficacy signals that we're seeing is that the FDA in our pre-IND meeting required a very, very small Phase 1. We're not going to go into specifics right now because we're still finalizing the design.

However, we expect this to be a very modestly size study. I can tell you it's probably going to be less than 25 patients, maybe even smaller than that. But again, very small study.

And because of the fact, the good news is when we had our pre-IND meeting, the FDA is already familiar with vorolanib because it's already gone through Phase 2 and it's already very familiar with Durasert. So because of those two factors, they are very comfortable with us moving quickly into a small Phase 1 and then into a larger Phase 2.

I'll now turn it over to Dario to talk to us a bit more on the efficacy signals seen with oral vorolanib. .

Yes, thank you. So the oral vorolanib formulation was actually tested in two studies, Phase 1 and Phase 2 as pointed out. The first study was an open-label, dose escalation study in about 35 patients. These were patient for the most part who have been pretreated with anti-VEGF treatment.

So the idea was first of all, the objective was, first of all, to determine safety. And second also to possibly see evidence of efficacy. And indeed, we actually see some improvements in visual acuity. And quite a number of patients, about 60% of them, actually did not require a rescue with injections.

We observed not only increasing visual acuity, but also a reduction in the retina thickness. And very importantly for that study also no adverse event associated with any ocular findings. So that study justify moving to a Phase 2 study. The Phase 2 study was a larger study. It was about 150 patients randomized. And again, three doses oral doses.

And again, these patients were also patients that were had responded well to anti-VEGF therapy. And the study was terminated early only because there were systemic side effects associated with the oral product. But in about half of the patients who actually completed the study through one year.

Again, we observed stabilization of visual acuity and essentially a 50% reduction in the need for rescue injections. Also, very importantly in this study again no significant ocular events. So essentially those two studies confirm the fact that the vorolanib orally is actually active and is also having acceptable ocular safety..

Okay, great.

And then just another follow-up, on your comments earlier around the kind of demand seasonality, should I take that as we should expect revenue to be down, I guess, quarter-over-quarter into 1Q and just how much of that is related to pharma seasonality versus some of the dynamics going on with your distributors? And then another follow-up on DEXYCU, I think, you mentioned you had trained ASCs representing about $170 million market.

How should I think about the pace of that increasing throughout 2020 and just kind of what are the big gating factors to seeing that ramp? Thank you..

Thanks, Dana this is George. We're not going to guide specifically on quarter or the year except to say that we do expect to see continued underlying growth in demand. As you know, as we stated, we went from a single distributor to a multi distributor structure in the fourth quarter.

We expect that will sort through on as they sort out their inventory over time. And as 2020 progresses, we will – we expect revenue and demand to get more closely aligned. It will – we expect it to still be a little bit bumpy, but it's – I think the important message is underlying demand will continue to grow.

Q1 will be a little more modest simply because of the seasonality as Scott pointed out. And in fact we learned, I think, there's a conference almost every weekend in January and February for the cataract surgeons. So, clearly it's a time that they pause because their demand is down.

But that said, we still expect to see underlying customer demand to continue to grow..

And then Scott Jones will answer your second question Dana, around the contracts and ASCs..

Thank you. Thanks for the question, Dana. So as I mentioned earlier in the presentation, we're continuing to bring on additional customers through contracts, both in the private equity market as well as in some of the integrated health networks.

And we expect to see the addition of those contracts play out through the year in terms of underlying demand. We're ramping up actively in those areas to build. And really what it does it provides additional access for our representatives in accounts that are covered in by those contracts.

And we're already starting to see a return in the first quarter and we expect that to expand throughout the year..

Okay, thank you..

Your next question comes from the line of Andrew D'Silva from B. Riley FBR. You may ask the question. .

Hi, good morning. Thanks for taking my questions. Just a few quick ones from me. I’ll start off with YUTIQ I was just curious, was there any sort of benefits during the quarter from the Ozurdex supply constraints that were announced in early October.

And then if you remember, we did several channel checks and there was a contingent of like retinal physicians that say entered the space before 2005 that were generally unfavorable to implants in the market specifically due to issues with Retisert.

And I was curious if you were noticing any pushback from that in the market or if that just really been an issue at this point?.

All right, so let me answer your question. As for Ozurdex, no, in all candor we really did not see any impact from Ozurdex.

And remember too, what we're seeing with the use of YUTIQ versus Ozurdex, and in fact there was a very recent article published on this where physicians seem to be using Ozurdex and injectable generics is to bring down the initial inflammation and then they look to YUTIQ for maintenance.

And we've always said YUTIQ is not ever meant to be used when that initial patient presents where their eyes are almost always seriously inflamed, they've got all kinds of problems with it and you want to hit it hard with a more of a bolus injection and Ozurdex does give you this burst effect but then it quickly drops off.

So then that's where YUTIQ comes in. Once the patient is controlled they use YUTIQ. So to your answer, we don't see an impact from Ozurdex having been out of stock. What you're seeing is true underlying demand for YUTIQ. And your second question around a contingent of patients back in 2005, I think, you said….

Eye physician, it was retinal physician in the space, yes..

Yes,. Look, in all candor, look, most doctors though there still is some Retisert use, most doctors plan to move away from it. And why is that? Retisert is a surgical procedure, you've got to go into the ambulatory surgery suite and have surgery, YUTIQ can be delivered in the physician's office. It's $18,000 for one implant, ours is $8,900.

Retisert lasts for two years, Durasert lasts for up to three years. And the other nice thing about YUTIQ is you get less IOP than you see in the clinical trials with Retisert. So we're just – we're not seeing hesitancy to put an implant.

And the other thing I will tell you that's helping us is that ILUVIEN has been on the market for three years – or excuse me, for five years for DME. And because these are basically identical products, they just aren't seeing any problems with ILUVIEN inserting it. And so as a result they're much more comfortable using YUTIQ..

Okay. No, that's good to hear. I just wanted to make sure. And then just moving over to DEXYCU, can you just maybe discuss the broader market in a little bit more detail. So I know the C-code issue with other offerings created some headwinds out-of-the-gate here.

But how much have just changes in the broader ASD market from like a private equity roll up standpoint played a factor here versus just the J-code C-code confusion.

So for example, looking at Omidria the sales when it was on a C-code and going through pass through for the initial diverse three years with a similar ASP, we’re trending significantly ahead of DEXYCU. But with that being said, obviously there has been a change in the ASC market in some capacities.

I'm curious when you look at it as a whole, how much of the change from where you initially thought you would be to where you were now with DEXYCU, specifically was maybe a broader market shift versus a coding issue..

Okay, so I'm going to let Scott answer that question, but let me just give one quick highlight.

Which is there's no doubt that shifting the control of what’s used in the ASC from a physician owned ASC where the doctors really call shots to more of an integrated delivery networks who all needs now a lot of them, a majority of them and private equity owned has taken a lot of control away from doctors.

Now it's still important – doctors still have to say yes, they want to use it, but they can't dictate anymore what gets used. So as a result we now have to go that extra step and get these contracts signed with private equity firms to integrate delivery networks. I'm going to let Scott further elaborate..

Sure, thank you Nancy. So I'll answer the first part of the question relative to Omidria. I think it is difficult to look at Omidria versus DEXYCU one-to-one because Omidria obviously has a much different and broader indication and the utilization is outside of just the post surgical inflammation.

However, one of the things that you said, which is relating to the reimbursement challenges of a pastored product is right on the money. The process for ASC is getting comfortable with passthrough has certainly changed over time.

And I think part of that is comfort level with both a permanent J-code now, which is different than the C-code that Omidria launched with and that we certainly launched with. So I think that is one big change in the marketplace.

But relative to your broader question about the market, as Nancy said, the market has changed considerably over the last several years. It used to be dominated by physician-owned ASCs. Now the physician-owned and community hospital owned segment is the small segment of the ASC market.

Private equity is taking up a larger share, but still the largest share is – are those ASCs controlled by the chains HCA, et cetera. And so the primary issue relating to implementing a product in the surgical space is related to access into those markets.

And clearly that's what our strategy and the discussion today implies is that we're actively trying to create additional access in all of those target market opportunities..

Okay. Thank you for the color on that. I have two more quick ones here.

I pardon my memory is not perfect here, but EYP-1901 effectively the same delivery platform that you had with that Tethadur product you were developing a few years ago with Avastin or is it different since that was utilizing a mab versus a small molecule? And mostly just curious, is there a reason to go with a six-month versus three-year or is the plan to develop a six-month and move out to a three-year eventually..

Okay, I'll answer some of that. I'll let Dario opine as well. So first of all, Tethadur is dead, buried and long gone. That was a silicon-based delivery mechanism, it did not work. We killed that program a long time ago.

This is using Durasert and that's the one thing we also like about this and why we think this program is relatively de-risked, or should say, I want to be careful here potentially, relatively de-risked versus other programs out using sustained delivery for anti-VEGF.

Why is that? Because we’re using Durasert, Durasert is used in YUTIQ, ILUVIEN and Retisert and by the way long ago Vitrasert, it's the same excipients. The only difference is that we're using now bio-erodible Durasert, whereas YUTIQ, and ILUVIEN and Retisert are non-erodible. The main difference is that we are not using a polyimide tube.

And I'm not going to go into other details because its proprietary, but for the bio-erodible there's no polyimide tube. Whereas there is one in the non-erodible. Important to note there is no new excipients in the bio-erodible versus the non-erodible Durasert. So there's other things we've done to it but there's no new added ingredients.

So as a result, because Durasert has proven so safe in patients over the years. And thousands of patients have been injected with the non-erodible form of Durasert. We do believe that we've got a well-proven drug delivery technology that we're using with EYP-1901 as to six months versus three years.

Let me again state this in uveitis where we have three years, it's a totally different disease. That disease, again, it's because you get these unpredictable flares, these patients are young, they're usually in their 40s you have no idea when you're going to flare so you need a longer delivery mechanism.

And as a result, doctors liked the three years with YUTIQ for uveitis. It's different when you get into these chronic diseases that are – they progress slower than uveitis, like wet AMD. And as a result, what we found out in the marketplace, most doctors want a delivery device that delivers an anti-VEGF six to twelve months.

They really don't want something that goes longer. There's a couple of reasons for that. Number one, they really want to make sure that they keep control of the patient. And they want to make sure that they are on top of this disease.

And that when you get out longer than that, it's just the cost goes up, number one, for the patient, the cost goes up for the doctor.

And remember, unlike uveitis, which is an orphan disease and you might see a handful of patients, these wet AMD, DME, and RVO markets, you go into these doctors’ offices, again, they're like factories, the patients are getting lining up to get their injections every month to every other month.

Right now that's what they are being treated with and with Beovu once potentially once every three months. So it's running a lot of patients through and as a result, they want to be able to maintain contact with these patients and get out to six months to 12 months without going all the way out to three years.

The second thing is, and I think it needs to be stated, is doctors do derive some income off frequent injections. And you get out too far, they have to bear the cost of a more expensive product and they don't get to inject as frequently. That's just the reality of this marketplace.

So they do like these shorter-acting, but long enough that you get better compliance. I'm going to turn it over to Dario to comment anything..

No, I think, Nancy I really don't have any additional comments. I think you covered all the points I would have covered. .

Okay..

Yes, thank you..

And just probably a couple of bookkeeping questions. What was cash flow from operations and CapEx for the year? And then last year you noted from a cash flow standpoint that you would expect to be cash flow positive this year.

Obviously, George wasn't there at the time, I'm just curious if that's still a benchmark we should be targeting?.

No, we – thanks for the question, Andy. As we look to invest in EYP-1901 – as we think about cash and as I mentioned in my prepared comments is that we expect cash on hand from both at the end of the year the financing and generated from continuing success with the commercial programs will fund us into next year.

The way to think about the commercial programs is over time we expect that with continued commercial success that those commercial programs should largely fund our operating costs. And then we would look to fund R&D in the future separately..

Okay.

And did you happen to have your CapEx and cash flow from operations for 2019?.

Well that, we'll file that in the 10-K likely next week. But it's not too inconsistent from the run rate through Q3..

Okay, great. Thank you very much. Best of luck going forward..

Thanks Andy..

Your next question comes from the line of I-Eh Jen from Laidlaw & Company. You may ask your question..

Good morning and thanks for taking the questions. I'm just going to start with the pipeline product, EYP-1901, which is that little longer-term question, which is that you have three indications you can explore.

Is there a priority in terms of which what and how would you prioritize that?.

Yes, wet AMD first, then RVO, then diabetic retinopathy, in that order. So we'll probably go after wet AMD first. So again, we're still in the early stages of sorting through all that..

Yes, I think the way to think about that is the Phase 1 study should support all. There are other folks out there with similar programs targeting these and will certainly learn from that, but right now we're focused on having the Phase 1 be able to support multiple indications..

Yes. And let me also state for the listeners to just remind people that wet AMD is a very developed market. It's a multi, multi, multibillion dollar market. And as a result, it is the one that has some of the highest unmet need in it in terms of needing this sustained delivery. But it also is the larger of the three markets.

And again, if you look at the main products on the market, it's, Eyelea – excuse me, Lucentis, which is delivered monthly, injected in the eye every month, usually for the rest of patients’ lives. And then Eyelea, which is injected usually every other month.

And then the second – and if you recall when Eyelea was launched, they quickly overtook Lucentis mostly because of the fact that you were able to diminish that frequent eye injections. And then now Novartis has launched Beovu, which is up to three months injections into the eye.

And again, the goal is every time they are trying to extend out the number – the length of these eye injections. And so that kind of is the Holy Grail right now, get these patients out as long as possible up to one year, no longer than that, generally with less frequent eye injections. That's why we're so excited about EYP-1901..

Okay, great. That's very, very helpful. And also, maybe just to tag on just a little bit, in terms of your cash and you say you're going to file IND toward the end of the – or toward in the fourth quarter of this year, I guess.

So was the cash at this point, you would anticipate at least complete or a start of Phase 1 study given that’s a smaller study or you were totally depend on other as sort of resources going forward, just for the Phase 1?.

Yes, so I think important to note is that the Phase 1 is not a big investment. We're looking at likely single digit millions of investment. So it's certainly something that we can accommodate in our operating plan..

Okay.

And that you already consider that into your budget at this point in terms of when you guided the cash runway?.

Yes, that's baked in, absolutely. We do have cash sticking out bid next year on our current cash. As I stated earlier, cash and operating – continued success with the operating plan..

Okay, great. One more question on the penetration to the private equity on ASC, I know this is still in early stage relative early stage.

Can you quantify that a little bit in terms of how far you have been in terms of none – if you can, you presented you otherwise use other metrics and what sort of a goal you hope to achieve toward end of this year in terms of that particular set of ASC?.

I-Eh let me make sure I understand. Are you saying what percent of ASCs we penetrate market share wise, is that your question? I want to make sure we got your question right..

No, the ASC particularly in the private equity owned one because that major upcoming, growing one and that's probably the biggest target you guys just want to sort of achieve?.

Okay, I'm going to turn that question over to Scott..

Sure, thank you. So this part of the market is evolving and there are a number of private equity players in the marketplace. However, there is, I would say, the smaller portion of that are those private equity firms that have gobbled up enough ASCs to have put in place management companies.

Those were the principal ASC private equity owned ASC that we're targeting. As we've talked about during the call, we recently completed contracts with two of those, we’re negotiating several more, but that will continue to be throughout the year. As that part of the market evolves we'll continue to focus and expand in that market opportunity..

Your next question comes from the line of Yi Chen from H.C. Wainwright. You may ask your question..

Thank you for taking my question.

My first question is, is it possible for you to provide some color regarding the breakdown, the fourth quarter product revenue between DEXYCU and YUTIQ?.

Did you say first quarter or fourth quarter Yi?.

Yes, sorry, fourth quarter, fourth quarter, the last quarter..

Yes, so it's in the release, but I'll give you the numbers now. So let me just pull it up..

Yi, it was 12 – for the year, I want to be clear for the year it was $12 million YUTIQ and $4.8 million DEXYCU. And George would get you the – yes, okay, $4.8 million for YUTIQ in Q4 and $3.1 million for DEXYCU, for total product revenue of $7.9 million..

For the quarter..

For the quarter..

Okay, thank you. Okay, thank you.

And regarding that number, 14,000 patients treated with DEXYCU since launch, does that number also include patients treated in the first and second – January and February of 2020? And if so, can you provide us with a number of patients treated in 2019?.

First of all, you got to remember the 14,000 also includes some sample usage. So it's a total number of patients that were injected. And of course when you go out and launch you're going to have some sample usage.

The main point there is we wanted to make sure that we had good safety and efficacy in all these patients and that's basically what we have seen. But we're not going to give color on exactly how many patients were given in 2019 versus now, you said 2020, I think. So basically the 14,000 is what was all injected in 2019.

We haven't given any guidance or numbers for 2020 yet..

And again, keep in mind that as these ASVs are trained and brought up to speed, there is sample usage as they get up to speed on how DEXYCU is delivered. So we don't give granularity. We're not really ready to get granularity beyond that yet..

I am showing no further question at this time. I would like to turn the conference back to CEO, Nancy Lurker..

I want to thank everyone for your time today. And we look forward to keeping you updated on our commercial launch progress, as well as our exciting pipeline initiatives in the coming quarters. Thank you very much for your continued support..

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation and have a wonderful day. You may all disconnect..