EyePoint Pharmaceuticals Q1 2025 Earnings Call Transcript

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May 7, 2025
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Operator

Good morning. My name is Towanda, and I'll be your conference operator today. At this time, I would like to welcome everyone to the ICON First Quarter twenty twenty five Financial Results and Recent Corporate Development 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 risk request.

Operator

I would now like to turn the call over to George Elston, executive vice president and Chief Financial Officer of AppLint. Sir, you may begin.

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

Thank you, and thank you all for joining us on today's conference call to discuss EyePoint's first quarter twenty twenty five financial results and recent corporate developments. With me today is Doctor. Jay Duker, President and Chief Executive Officer of EyePoint. Jay will begin with a review of recent corporate updates and discuss the ongoing clinical trials for DuraVu. I will close with commentary on the first quarter twenty twenty five financial results, and we will then open the call for your questions.

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

Earlier this morning, we issued a press release detailing our financial results and recent corporate 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 products and 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 ks, which is on file with the SEC and in other filings that we have made or may make with the SEC in the future.

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

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 Doctor. Jay Duker, President and Chief Executive Officer of iPoint.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Thank you, George. Good morning, everyone, and thank you for joining us. We are proud to report yet another quarter of exceptional execution as we advance our lead program DuraVu through late stage clinical development. Notably, we continue to receive strong positive feedback from both physicians and patients for our ongoing global Phase III trials, Lugano and LUTIA for DuraVu in wet age related macular degeneration or wet AMD, underscoring the impressive enrollment rate we are seeing. In fact, as we reported in this morning's press release, we have randomized over ninety percent of patients into the Lugano trial and over fifty percent into the LUCIA trial.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

This gives us great confidence that we will meet our time line to complete enrollment in the second half of twenty twenty five and deepens our conviction that DuraVu is on track to be the first to market of the current investigational sustained release treatment for wet AMD. We believe this clinical momentum highlights the significant opportunity for DuraVu as a differentiated treatment option in treating retinal disease. Our team is committed to our goal of delivering life changing treatments to patients with severe retinal diseases beginning with wet AMD. I want to take a moment to review why we believe DURAVU is a best in class program and represents a compelling and strategically derisked opportunity in wet AMD. First, DURAVU is not another anti VEGF program.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

DURAVU is clinically validated differentiated and potentially best in class sustained release TKI. DuraVu's receptor level inhibition of VEGF blocking all isoforms of VEGF offers a broader and possibly more durable disease control compared to current ligand blocking therapeutics. By also blocking PDGF receptors, DuraVu may help reduce fibrosis, a key driver of long term visual loss, which could further differentiate this potential wet AMD therapy. Next, DuraVu's efficacy is supported by our Phase I and Phase II data sets, which are the most robust investigational data sets in wet AMD amongst all sustained delivery programs. In our Phase II WO2 trial in wet AMD, in a tough to treat population, approximately two thirds of patients remained rescue free for six months and nearly half remained rescue free for one year with stable vision and anatomy from a single DuraVu treatment.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

DuraVu has established a very favorable safety profile with no DuraVu related ocular or systemic SAEs observed in over one hundred and ninety patients evaluated across clinical trials for multiple indications. Additionally, there are also four FDA approved products using our DuraSert technology administered to tens of thousands of patients in real world settings with a strong safety record. Our Phase III non inferiority program was developed in direct alignment with the FDA, follows recognized industry best practices and is strategically designed to enhance the probability of both regulatory and commercial success. And finally, DuraVu has the potential to address a large unmet need in an established and growing multibillion dollar market where patients are actively seeking safe, durable, longer acting treatments. I want to also highlight our excitement around the potential for DuraVu in diabetic macular edema or DME.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

While our company is currently focused on the execution of our wet AMD Phase III program, our recently reported positive twenty four week Phase II results in DME further validates both the mechanism of action of vorolanib and the commercial potential of our DuraSert E technology across multiple large retinal disease markets. Turning to wet AMD, our goal in the Phase III trials is to demonstrate that DuraVu can maintain stable vision and retinal anatomy for the majority of wet AMD patients within every six month dosing schedule. This would represent a significant improvement compared to the current anti VEGF treatments in The U. S. That are dosed on average every two months.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

From a clinical perspective, this would provide patients and practitioners with the flexibility to reduce the number of visits without sacrificing visual outcomes and would ensure compliance over that six month interval. Since initiating our Phase III trials, we've seen remarkable patient and physician interest, supporting the life altering potential of DuraVu. I'm pleased that both the Lugano and LUCIA trials continue to meaningfully surpass our enrollment expectations with patient randomization in excess of ninety percent for the Lugano trial and over fifty percent for the LUCIA trial. These enrollment rates significantly exceed those observed in comparable historic and other ongoing wet AMD trials, which we believe is driven by Duravu's robust clinical data package, including an outstanding safety profile and established efficacy demonstrated in the robust WO2 Phase II trial. This also highlights the significant need for more durable treatment options.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

The continued support and enthusiasm for DuraVu from the retinal community not only reinforces our expected enrollment completion in both pivotal trials in the second half of this year, but also reaffirms our confidence in our derisk trial design. Our global double masked identical trials reflect a tried and true non inferiority design used in the last four wet AMD drug approvals. There are several key reasons why we believe our well powered rigorously controlled program is structured to produce data that support approval and are meaningful for retinal specialists and patients. First, the Lugano and LUCIA trials were specifically designed for regulatory and commercial success. Our trial design was informed by a robust Phase II trial and multiple FDA interactions with written agreement from the agency on our path to approval.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Second, our trials incorporate a fixed, prespecified every six month dosing for DuraVu, a clean, predictable design that mirrors intended real world use and that provides a clear regulatory pathway. Learning from our Phase II, supplemental injections are only permitted if a patient meets strict predefined criteria and are adjudicated in a mass manner to minimize variability and bias. Our disciplined protocol is aimed eliminating physician discretion in unnecessary supplemental treatments. Finally, the inclusion of both treatment naive and previously treated patients enhances the broad applicability of our data and can support not just approval, but increased physician adoption and a potentially broader label. As we continue to execute in the clinic, we are also laying the foundation for a potential commercial launch with our state of the art GMP compliant manufacturing facility in Northbridge, Massachusetts.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Our facility is operational and will be capable of producing more than 1,000,000 derivative treatments annually to support expected global demand. Importantly, we are well positioned with regard to potential tariff impacts as we also source our API from a U. S.-based manufacturer. Turning to our DME program, DuraVu met the trial's primary and secondary endpoints for our Phase II VORONA trial, demonstrating compelling efficacy and durability results. Duravu is the only sustained release TKI program with demonstrated activity and safety in DME.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

DME is the second largest retinal disease indication, representing a $3,000,000,000 market opportunity by 02/1930. We believe DuraVu is uniquely positioned to potentially extend the therapeutic dosing interval compared to currently available treatment options. To recap the VORONA results, both DURAVU doses met the primary endpoint of longer time to first supplement versus the aflibercept control. DURAVU two point seven milligrams demonstrated an early, sustained and clinically meaningful improvement in best corrected visual acuity or BCVA with a gain of 7.1 letters compared to the baseline and a central subfield thickness or CST improvement of 76 microns on OCT measurement. This represented a 75% more drying effect versus the aflibercept control.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Immediate bioavailability demonstrated from the visual and anatomic gains observed as early as week four and were much more robust than those achieved in the aflibercept control eyes at this time point. A subset of unsupplemented patients further supported the robust results for the DERAVU arms. These highly positive Phase II data will be critical in our planned engagement with the FDA this summer to solidify plans for a pivotal program. In summary, our identical pivotal Phase III Lugano and LUCIA trials in wet AMD are exceeding expectations and remain on track to complete enrollment in the second half of this year with top line data for both trials in the second half of twenty twenty six. The positive safety and efficacy data from the Phase II VORONA trial in DME further strengthens profile as a potentially paradigm shifting treatment option and positions DuraVu to become a potential multibillion dollar blockbuster franchise in the two largest retinal diseases.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Finally, thank you to the entire EyePoint team for another strong quarter and for your unwavering commitment to our collective goal of improving patients' lives through better vision. Outside of our organization, it's been humbling to see such high levels of engagement from the patients and clinical investigators eager to participate in our ongoing trials. We deeply appreciate your confidence in us, and we're proud to advance our therapeutics for the benefit of the entire retina community. With our best in class sustained ocular delivery technology and promising clinical pipeline across multiple blockbuster indications, we look forward to continued progress towards our upcoming milestones as the leader in sustained ocular drug delivery. I will now turn the call over to George to review the financials. George?

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

Thank you, Jay. To begin, we continue disciplined financial management and good stewardship of our resources, ending the first quarter with $318,200,000 in cash and investments. We affirm previous guidance and expect this cash will support our operations into 2027 beyond key data readouts from our Phase III Lugano and LUCHIA pivotal trials next year. As the financial results for the three months ended 03/31/2025, were included in the press release issued this morning, my comments today will be focused on a high level review for the quarter.

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

For the quarter ended 03/31/2025, total net revenue was $24,500,000 compared to $11,700,000 for the quarter ended 03/31/2024. Net product revenue for the quarter ended 03/31/2025, was $700,000 consistent with the quarter ended 03/31/2024. We expect net product revenue to continue at immaterial levels as we will no longer be supplying YUTIQ to ANI Pharmaceuticals, our U. S. Partner, after 05/31/2025.

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

Consistent with our strategy, our manufacturing focus forward is on our DuraVu program to support clinical trials, a potential NDA filing and future commercial launch. Net revenue from royalties and collaborations for the quarter ended 03/31/2025, totaled $23,700,000 compared to $11,000,000 in the corresponding period in 2024. The increase was primarily driven by recognition of remaining deferred revenue from the outlicense of YUTIQ U. S. Rights in 2023.

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

Operating expenses for the quarter ended 03/31/2025, totaled $73,300,000 compared to $45,000,000 in the prior year period. This increase was primarily driven by the ongoing Lugano and Lucia Phase III trials for DuraVu and wet AMD as enrollment is tracking ahead of expectations. Net nonoperating income totaled $3,600,000 and net loss was 45,200,000.0 or $0.65 per share compared to a net loss of $29,300,000 or $0.55 per share for the prior year period. As I noted earlier, cash, cash equivalents and investments in marketable securities on 03/31/2025, totaled $318,200,000 compared to $371,000,000 as of 12/31/2024. In conclusion, we are incredibly pleased with EyePoint's progress so far in 2025 and remain well capitalized to deliver DURAVUE Phase III data in 2026.

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

I will now turn the call back over to Jay for closing remarks.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Thank you, George. As outlined this morning, we ended the first quarter in an excellent position and remain committed to advancing DuraVu, a best in class program across multiple indications in retinal disease. We believe EyePoint represents a significant investment opportunity that is meaningfully derisked, both clinically and financially. Our strong balance sheet will enable us to execute on our upcoming clinical milestones, which include enrollment completion in the Phase III LuganoLucia trials in wet AMD expected in the second half of twenty twenty five top line data for these trials anticipated in 2026 and an end of Phase II meeting with the FDA around a pivotal trial in DME this summer.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

To close, 2025 is off to a great start for EyePoint. The progress we've achieved to date underscores our dedication to advancing our pipeline and delivering innovative treatments to improve the lives of patients suffering from serious retinal diseases. We're very excited to continue our momentum and look forward to providing additional updates in the coming quarters. Thank you all very much for your attention this morning. I will now turn the call back over to the operator for your questions.

Operator

Thank you. Ladies and gentlemen, to ask a question, please press 11 on your telephone, then wait for your name to be announced. To withdraw your question, please press 11 again. As usual, we'll try to get to as many questions as we can through the course of the call. But if you limit the number of questions you ask to one, it will give others a fair chance to participate.

Operator

Please stand by while we compile the Q and A roster.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

And before we start with the Q and A, I would like to reiterate a few points that we just made. At EyePoint, we're completely focused on the execution of our pivotal Phase III wet AMD trials, Lugano and Lucia, and the preparation for our NDA filing, which includes manufacturing of registration batches in our Northbridge, Massachusetts commercial facility. Based on our terrific Phase II WO2 data, the rapid enrollment in our Phase III trials and the continued clean safety profile for DuraVu, we are confident in the value creation that successful Lugano and LUCIA results will produce. With respect to strategy, we are focused on value creation for our current shareholders while advancing Duravu through Phase III trials. This means good stewardship of our cash while maximizing the value of Duravu. We're now happy to take some questions.

Operator

Thank you. Our first question comes from the line of Jennifer Kim with Cantor. Your line is open.

Jennifer Kim
Equity Research Director at Cantor Fitzgerald

Hi. Good morning.

Jennifer Kim
Equity Research Director at Cantor Fitzgerald

Congrats on the progress, and thanks for taking our question. Maybe to start off, I understand that you've reiterated guidance to complete case enrollment in the second half of this year. But just looking at the pace of enrollment here, it seems like you guys are well on track to complete enrollment, maybe earlier than investors appreciate. Am I thinking about this the right way, can you help us walk us through the math here?

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Good morning, Jennifer, and thanks for the question. We are still guiding to full enrollment in both trials in the second half of this year. But but, yes, if if you look at the public statements we've made around enrollment and, you know, kind of draw a line through the the data points, we could certainly potentially have completion of enrollment in the first trial Lugano in the second quarter of this year. That remains to be seen. You can may know that the start of the Lucia trial was approximately two months or so after Lugano, and we would expect that the Lugano results will come in approximately two months after Lugano as well.

Jennifer Kim
Equity Research Director at Cantor Fitzgerald

Okay. That's helpful. And if I could sneak in one more question, just because DME underappreciated opportunity, can you just remind us what you're looking for in your upcoming meeting with the FDA and just some comments on, I guess, timing and and potential outcomes? Thanks.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Sure. We have our chief medical officer, Romero Ribeiro, on on the line also. Romero, do you wanna talk a little bit about the upcoming end of phase two meeting with the FDA over DME?

Ramiro Ribeiro
Ramiro Ribeiro
Chief Medical Officer at EyePoint Pharmaceuticals

Sure. Hey, Jennifer.

Ramiro Ribeiro
Ramiro Ribeiro
Chief Medical Officer at EyePoint Pharmaceuticals

So we are gonna be proposing a clinical plan, meaning a phase three study, that brings efficiency to our program. So we are gonna propose one single study comparing our drug to standard of care, and the primary endpoint is gonna be as expected for the new trial BCVA. We're planning to have the meeting with the FDA soon, as as Jay mentioned, and we have that by by this summer.

Jennifer Kim
Equity Research Director at Cantor Fitzgerald

Thanks again, guys.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Tess Romero with JPMorgan. Your line is open.

Tessa Romero
Tessa Romero
Equity Analyst at J.P. Morgan

Hey, Jay and team. Thanks so much for taking our questions this morning. A big picture, so what do you attribute the rapid pace of enrollment here in your phase three wet AMD trials? Anything anecdotally you can tell us on what you are hearing from your clinical sites? And secondly, where are you most focused in terms of clinical trial execution in terms of mitigating any risks? Terrific

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

questions, Tess. Thank you very much for them. And again, I'm gonna attribute most of our success in the rapid enrollment to Romero and his team, and I'm gonna let him again answer that question on on on why it is that we're rapidly enrolling as well as what he and his team are focusing on to make sure our our results are sound.

Ramiro Ribeiro
Ramiro Ribeiro
Chief Medical Officer at EyePoint Pharmaceuticals

Yes, Des. Thanks for the question.

Ramiro Ribeiro
Ramiro Ribeiro
Chief Medical Officer at EyePoint Pharmaceuticals

So I think the number one feedback we get from investigators is that our study is patient centric, is easy to follow, and the robust data that we have from phase two study as well as our phase one program give them confidence when they are discussing to a patient and potentially offering participation in the study. Of course, we do a lot of things to make the study easy for sites and patients. But the most important part is the robust data that we have that gives confidence to investigators and patients. I think we are doing an excellent job identifying any potential risk in our phase three program on the conduct of this study. So we look at all areas to ensure the integrity of the data is pristine so that it can be efficient on our NDA submission.

Tessa Romero
Tessa Romero
Equity Analyst at J.P. Morgan

Thank you.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Tyler Van Buren with TD Cowen. Your line is open.

Tyler Van Buren
Managing Director, Senior Biotech Equity Research Analyst at TD Cowen

Hey, guys. Good morning. The enrollment progress is very, very impressive. So with the increased time lines to enrollment completion in the Lugano and LUCIA trials, does it make sense to potentially run a small Phase II study in RVO considering that it is a significant additional opportunity and part of the market beyond wet AMD and DME. Is there any way that you could do this in a cost efficient manner as we wait for the Phase III data?

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Yes. Hi, Tyler. Thanks for the question. And it is really something that we've thought about really more in the long term of how we can create more value around Duravu and what are the other potential add on indications. RVO is certainly one of them.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

But but as I stated in my comments, we are really focused on wet AMD right now and on our our cash runway after data. And so the value that we would get at this point from an RVO trial probably is not something that would suggest to us that it's a pathway we would take right now. With the anticipation of and the hope of good data, great data from our Phase III program, I'm sure you'll see expansion into other areas for which Durovu might be beneficial, such as RVO. And I think there's some areas which you could certainly think about other expansion of the market, too. For example, we think with the growing number of high myopes in the world that myopic chromogastrication would be another area that the review would do very well in.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

So yes, this is part of the longer term program, but I don't think we're going to see it in the short term.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Yatin Suneja with Guggenheim. Your line is open.

Yatin Suneja
Senior Managing Director, Biotechnology Analyst at Guggenheim Partners

Hey, guys. Thank you for taking my question. Maybe just a quick one for me. Are you able to comment on the screen failure rate for both studies? Also, the type of patient or the mix of patient naive versus, like, an exposed patient that you are able to enroll.

Yatin Suneja
Senior Managing Director, Biotechnology Analyst at Guggenheim Partners

And anything you are able to comment on the safety side, at least on the blinded basis given that one study is almost complete with from an enrollment perspective? Thank you.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Thanks, Jatin. Nice to hear from you again. With respect to screen failure rates, what I can say is, historically, screen failure rates in wet AMD are approximately fifty percent, and we're doing a little bit better than that in both trials.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

And there's always some learning. You know, the screen failure rates at the beginning of the trial tend to be a little higher. And as the doctors understand exactly what type of patient meets the criteria, the screen failure rates do go down, and we're seeing that in both trials. With respect to the mix of naive versus previously treated, we're going for approximately seventy five percent naive, twenty five percent previously treated. And given the reality that previously treated patients are already practices and can be identified ahead of time.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

We anticipated at the beginning of both trials, most of the enrolled patients would be previously treated. And that's, in fact, what we saw. And early on in both trials, we capped the the number of of patients who were previously treated. We capped the enrollments so that from now and both trials, we're just recruiting naive patients, and this is again to be expected. What we've been very surprised about is we expected that the rapid enrollment seen early on with the allowance of previously treated patients would slow down once we cap them, and we didn't see that.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

What's been remarkable is that in both trials, the enrollment rates have been very high and very steady. As for release of mass data, we really aren't thinking about doing that right now. I think we might do that in the future. Certainly, things like mass data around demographics of the patients would not be something that would compromise the registrational trials by introducing any operational bias or the ability to have a well controlled trial. But we're certainly not going to disclose things piecemeal, and we're certainly not going to disclose any masked Phase III results just because of the risk of compromising the data and the increasing operational bias.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

So with respect to safety, what I can say in general is that based on our public statements prior, the safety of the review has been very, very good.

Yatin Suneja
Senior Managing Director, Biotechnology Analyst at Guggenheim Partners

Excellent. Thank you.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Hamid Jaffe with Jefferies. Your line is open.

Kambiz Yazdi
Kambiz Yazdi
Vice President - Equity Research at Jefferies Financial Group

Okay. Thank you so much for the questions. A couple for me. How should we model r and d going forward? And then separately, I was I was curious if it be so kind of the provider's perspective on how biosimilars are shaping the wet AMD market.

Kambiz Yazdi
Kambiz Yazdi
Vice President - Equity Research at Jefferies Financial Group

Would you consider biosimilar flip aflibercept loading in a post marketing study for DuraVu? It's obviously not at all a focus for you right now, but I'm curious on your perspective if there could be any value in exploring that. Thanks, Kavish.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Appreciate the questions. Let me take the second one first, and then I'll ask George to comment on R and D costs going forward. First of all, we're agnostic to the biosimilar market, whether a doctor if and when we get approval with an every six month dosing interval, what the doctor chooses to load with before the use of the review, we're really agnostic to that. We have no reason to believe that a biosimilar aflibercept would behave any differently than any than on label aflibercept. The rest of it, with respect to any other loading of the NANC HF, whether it's off label Avastin, Lucentis, Lovisomow, the three monthly doses, you wouldn't expect a patient to respond any differently to any of them over those first three months.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

So if you look at all of the curves of all the approved drugs and look at the first three months, they're really quite similar in their visual acuity improvement and the OCT improvement. So as a general rule, we wouldn't think the choice of a ligand blocker for the load would make any difference. George, do you want to go ahead and talk about anticipated R and D costs?

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

Sure. And, Candi, thanks for the question.

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

As I noted on the call, our R and D burn is up year over year, but that's really driven by the exceptional recruitment we've seen. And part two of that is our cash guidance is unchanged. So if you think about R and D in 2025, your prior year or your current model is probably correct for the full year. But we just spent more in Q1 because the trials are going so well. So I think full year is probably the same.

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

Just move some of that burn you may have in Q2 and Q3 up a little bit.

Operator

Our next question comes from the line of Greg Sullivanavia with Mizuho. Your line is open.

Analyst

Hi, all. This is Sam on for Greg. Thank you for taking our questions. Maybe a couple from me. Has there been some shortages that co pay assistance programs that we've been hearing from retinal disease companies impacting the enrollment in your studies in any way?

Analyst

And also as it relates to enrollment, can you point to anything specific in terms of either trial design or differentiating factors that one would choose enrolling in your study versus that of your competitors? Thank you.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Thanks for the question, Sam. And and they they are good it's good in good timing of the questions and and really topical. So that co pay assistance program that Sam mentioned is called the Good Days program, and it was funded to allow for co pays for patients who were not totally covered for their branded either wet AMD drug or GA drug for reasons that I'm not sure have been totally made public, but the companies that have funded Good Days in the past chose not to fund it so far in 2025.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

What this means is that patients who have the onset of wet AMD and do not have secondary coverage or coverage for the co pays and and want to be treated with a branded drug could have significant out of pocket costs. We expect that this is helping our enrollment because, obviously, we would offer, no charge, the drugs in our study. So that the lack of the Good Days program, I'm sure, is lifting all boats here, and I would expect that all of the wet AMD trials would benefit from that. As for specifics around why doctors are choosing our trial, we believe, first to a large degree, Again, I'd like to defer to Romero about anything specific that his interactions with our investigators and the investigational sites are telling him about this.

Ramiro Ribeiro
Ramiro Ribeiro
Chief Medical Officer at EyePoint Pharmaceuticals

Yes.

Ramiro Ribeiro
Ramiro Ribeiro
Chief Medical Officer at EyePoint Pharmaceuticals

Thanks for the question, Sam. As I mentioned, the the number one feedback we get from site is the fact that we have run a robust large phase two study. And that provides them confidence on the data, the efficacy data, but most important on the safety data that gives them comfort on offering this study to a patient knowing that we have those over a 90 patients with the review. And then after that, things like, you know, the study that is very patient centric. So every patient is treated in this study either with respect or with our investigational drug.

Ramiro Ribeiro
Ramiro Ribeiro
Chief Medical Officer at EyePoint Pharmaceuticals

How easy it is to conduct the study. It's not too burden to patients and physicians. And great support that EyePoint is providing to sites via our clinical operations team as well as our medical affairs team.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Nick Quartipala with Baird. Your line is open.

Nick Quartapella
Equity Research Analyst - Biotech at Baird

Hey, everyone. This is Nick on for calling. Thanks for taking our question. Congrats on the progress again. Just wanna get a little more color on how the FDA views the impact of rescues on the primary endpoint for wet AMD.

Nick Quartapella
Equity Research Analyst - Biotech at Baird

So I was wondering if there's a number on how many rescues are allowed, and is there a certain window where rescues are not allowed, for example, within a number of weeks before within the primary endpoint?

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Thanks for the questions, Nick.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

First of all, our interactions with the FDA around rescues have been consistent. They have not had any of the interactions either at our Type C meeting in 2022 or the end of Phase C meeting in 2024 suggested that there was a number of rescues by which a patient would be eliminated from the trial per se. What does that mean? Well, this is a intent to treat study that the top line data will be from all patients. And then sensitivity analysis will be applied to the patients who got supplemented or rescued.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

And and remember, in our trial, the control of fluttercept arm can also be rescued. So there will be also a calculation of the rescues compared in each arm. With respect to timing of rescues, that was not something that was ever brought up at either of our meetings, and there's nothing in writing that we've received from the FDA about waiting the the timing of of a rescue or that a patient who got rescued at a certain point of the study would be eliminated from the study. That that's not something that the FDA has brought up with us.

Nick Quartapella
Equity Research Analyst - Biotech at Baird

Great. Thank you.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Deb Chatterjee with Jones. Your line is open.

Debanjana Chatterjee
Director at Jones Trading

Hi.

Debanjana Chatterjee
Director at Jones Trading

Thanks for taking my question. So, you know, I have another follow-up on the biosimilars. So based on your payroll interactions, especially, let's say, at ARVO, to what extent do you see Amgen's past due impacting the wet AMD commercial landscape? And maybe could you comment on the potential for price erosion and any implications for deal review?

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Well, thanks for the the the question.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

And and there's something, obviously, that we've been thinking about in in in projecting. It's hard for me to answer the question about how the biosimilars will impact the market in general. Once again, with respect to DuraVue, we don't believe they'll have any impact on DuraVue's acceptance because we're a different MOA, different target, and we last six months or longer with a single injection, something that none of the biosimilars can do. Right now, the last data I saw was the biosimilar market was still quite small in The United States. I think it's running about 5% of the usage.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

And much of it, again, is driven by economics, economics either to the payer or to the physician practice. So I think in order to try to project out how biosimilars are going to be adopted, I think you have to take a look at the economics of them. And that's just a general statement that really, again, has nothing in particular to do with our drug. Pricing is something that we're thinking about and that we're working through. And again, George, if you want to make a comment at a high level how we're viewing pricing and whether we think biosimilars will impact that at all. Happy to have you comment.

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

Yes. And thank you for those questions. I think going back to what Jay said during the call is DERVIE is not another anti VEGF. And as you as our team thinks about approaching it in the marketplace, you know, we're bringing something very different.

George Elston
George Elston
Executive VP & CFO at EyePoint Pharmaceuticals

We're not another ligand blocker. We're bringing sustained delivery, new MOA, and that's gonna be a very important part of our negotiation, not just with FDA, but ultimately with payers. And so, you know, just broadly speaking, as we you know, end if you look at the trial design for DuraVu, you know, one DuraVu replaces three anti VEGFs. And so as you think about your pricing models, that's a good place to start.

Debanjana Chatterjee
Director at Jones Trading

Okay. Great. That's very helpful. Thank you.

Operator

Thank you.

Operator

Please stand by for our next question. Our next question comes from the line of Greg Harrison with Scotiabank. Your line is open.

Analyst

Good morning, everyone. Thank you for taking our question. This is Joe on for Greg. Just thinking to the future a little bit here. Assuming Lugano and Lucia will read out at different rates, is there a potential for rolling NDA submission?

Analyst

And how might that impact your top line data release strategy in the second half of twenty six?

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Thanks for the question, Joe. The NDA submission is really the rate limiting step is last visit, last patient in of the second trial, in our case, the LUGIA trial. From a rolling perspective, there's an internal rolling that we're doing already, which is preparing the various documents in the various sections that we already have. And we will fully expect to just as the data comes in from the two trials, drop the data into the documents so that we can shorten the time between last patient in top line results and actual NDA submission.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Romero, again, is really deep into this, and I'll ask him to make any other comments about steps that we're taking to minimize that time between last patient, last visit, and submission. Thanks, Jay.

Ramiro Ribeiro
Ramiro Ribeiro
Chief Medical Officer at EyePoint Pharmaceuticals

So as Jay mentioned, the limitation factor for the full submission is gonna be the last patient on the second study. However, since Lugano is enrolling quite fast, we we might have a good opportunity to accelerate things, especially interpretation of the results on the first study. And because the two studies are so similar, that would certainly bring efficiency when we are doing things for the second study.

Ramiro Ribeiro
Ramiro Ribeiro
Chief Medical Officer at EyePoint Pharmaceuticals

Meaning that, you know, there's a lot of analysis, interpretation, writing that needs to happen. If we do that for the first study, again, because the second study is identical, we'll certainly bring efficiency when we do that again for the second study.

Analyst

Okay. Thank you so much.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Gail James with Laidlaw and Company. Your line is open.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Thanks for taking the questions. Just I follow-up on the previous one to get some colors, which is when you do the data release next year, would that two data would that be sort of two month roughly two months apart for each of those, Or you have other plans and things?

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Morning, Yale. Thanks for the question. Well, approximately two months, I think, is likely.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

We'll know, obviously, when that last patient is enrolled in the first trial and then the last patient is enrolled in the second trial, the mathematics will be pretty easy at that point. Our plan, because we do expect them to be separated by several months, we will release the data as the data becomes available in each trial. But, again, we anticipate it will be approximately two months apart based on the study start and based on the similar enrollment patterns that we're seeing in both trials.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Okay. Great. Thanks, and congrats on the rapid enrollment.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Yishin with H. C. Wainwright. Your line is open.

Analyst

Good morning. This is Eduardo on for Yishin. Thanks for taking the question. I had a question regarding the baseline patient characteristics in the Lugano and Lucia trials. It seems like prior trials, had BCVA letters between thirty five and eighty five, and now it's between thirty five and seventy eight.

Analyst

I'm just curious if if you see what's the rationale behind using that cutoff at 78 instead of 75 letter 85 letters.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Sure, Eduardo. Good question. And and the answer to that is in the pivotal trials, I think the FDA has made it clear both historically and in the draft guidelines that you must enroll patients who have active wet AMD into your trials. And what what does that what does that mean?

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Well, they meet they have to have imaging that shows that they have AMD and that they have an active corolline vascular membrane, and they have to have decreased vision, and they have to have some fluid on OCT that is indicative of wet AMD fluid. So in order to have decreased vision, there's a cutoff. And historically, I think if you go back to the other wet AMD trials, 78 letters is is very typical for the best vision that is typically allowed into the study. So the the the quick answer to the question is you have to enroll patients with active wet AMD.

Analyst

Got it.

Analyst

That's really helpful. And maybe you mentioned this, but you you reported a subgroup within the DME trial at the 10.3 letter improvement. I'm curious what are the attributes of that patient population, and what fraction of the DME population share those attributes?

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Well, so that's a really good question about what attributes show it. First of all, it was a subgroup of patients in the DME trial in the high dose, the two point seven milligram dose, which is the dose we're using in wet AMD and the presumed go to market dose, in that dose of the eyes that did not get rescued, they improved 10 letters.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

So the implication being is when our drug works in DME, and it seemed to work in the vast majority of those patients out of the 11, it seemed to work quite well, in the majority, it works really, really well. Those patients who were not rescued had an immediate improvement in vision seen at four weeks. They had immediate reduction in their OCT seen at four weeks, and it was sustained in those eyes throughout the study. In other words, at the tail end near twenty four weeks, the visual acuities weren't dropping and the eyes weren't getting more more wet. And in fact, in that subgroup, they had about a 20 microns improvement in their OCTs.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

So for that subgroup, it worked really well. Even though if you look at the patients who did get rescued, there was perhaps only one patient out of that group that you would say that really had active disease during the trial despite the use of our drug. So the other eyes that got rescued got rescued because they didn't have over 10% improvement in their OCTs, but they were still doing pretty well even at the time of rescue. So be that as it may, it would be great to be able to identify those patients, which I think is what your question was getting at. And because the end of the trial was relatively low, I don't think we have enough data right now to state which of the patients who can go six months with great improvement and will not need a rescue.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Hopefully, we hope that obviously in the pivotal trials, we'll be able to elucidate that so that the retina community can identify the patients who are going to do best with the drug.

Analyst

Got it. That's really helpful. Thanks so much.

Operator

Thank you. Our next question comes from the line of Yigal Nochomovitz with Citigroup. Your line is open.

Yigal Nochomovitz
Yigal Nochomovitz
Director at Citigroup

Yeah. Hi.

Yigal Nochomovitz
Yigal Nochomovitz
Director at Citigroup

Thank you. Can you just walk through the thinking as far as the views on potentially being forced to file an NDA for the long acting TKIs given the strength of the enrollment curves that you're seeing across your Phase III program?

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

Thanks for the question, Yuval. I think the first two files, we talked a little bit about this. What is it dependent on? It's dependent on last patient in, in your second pivotal trial. And we have great confidence given the enrollment rates that we're seeing in our trials and the timing of the various trials of the other long acting agents that are out there.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

We are quite confident that we will get last patient in our second trial before any of the competitors do. Given the length of the trial, fifty six weeks, which is similar to what our competitors are doing. And the fact that our eyes get randomized on day one, there's no run-in before randomization. All of this gives us great confidence at this point that we will be first to file. And if approved, therefore, we will have the first to market advantage.

Yigal Nochomovitz
Yigal Nochomovitz
Director at Citigroup

Okay. And could you just review the positioning with respect to supply chain and IT? You may have talked about it at the beginning, but I may have missed it.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

So vis a vis supply chain for the commercial product, once again, as as we did talk about in the opening remarks, our API is manufactured in The United States, and our inserts are manufactured by us here in Massachusetts. The Phase III wet AMD inserts were manufactured in our facility in Watertown. We have built a state of the art manufacturing facility in Northbridge, Massachusetts, which is about an hour west of Watertown. And in that facility, we are in the midst of making registration batches and preparing for FDA premarket visits. And we're confident that, that facility will be able to supply the entire global need for DuraVu should we get approval.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

So from a supply chain perspective, we're really in control of the supply to a very large degree. And remember also, with the verlimid is a small molecule. It's not a biologic. It's not gene therapy. And as such, the manufacturing is relatively less expensive.

Jay Duker
Jay Duker
President, CEO & Director at EyePoint Pharmaceuticals

And because our inserts only contain each one, one point three four milligram of vorolanib, a batch or run of vorolanib can take us a very long way. So we are quite confident that our supply chain will be intact and that the tariff issues that some companies are facing, we think we are in good shape there.

Yigal Nochomovitz
Yigal Nochomovitz
Director at Citigroup

All right. Thank you very much.

Operator

Thank you. Ladies and gentlemen, I'm showing no further questions in the queue at this time. This does conclude your program.

Operator

Thank you for participating in today's conference. You may now disconnect. Everyone have a great day.

Executives
    • George Elston
      George Elston
      Executive VP & CFO
    • Jay Duker
      Jay Duker
      President, CEO & Director
    • Ramiro Ribeiro
      Ramiro Ribeiro
      Chief Medical Officer
Analysts
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Key Takeaways

  • DuraVu Phase III Trials: Enrollment in the global Lugano and LUCIA studies has surpassed 90% and 50% respectively, positioning the company to complete enrollment in the second half of 2025 and potentially be first to market with a six-month sustained-release wet AMD therapy.
  • Differentiated Mechanism: DuraVu is a sustained-release tyrosine kinase inhibitor that blocks all VEGF isoforms and PDGF receptors, backed by robust Phase I/II data and no drug-related ocular or systemic serious adverse events in over 190 patients.
  • Positive DME Data: The Phase II VORONA trial in diabetic macular edema met primary and key secondary endpoints, showing a 7.1-letter BCVA gain and 76 µm CST reduction with the 2.7 mg dose, supporting an end-of-Phase II meeting with the FDA this summer.
  • Strong Financial Position: The company ended Q1 2025 with $318.2 million in cash, cash equivalents and investments, providing runway into 2027 beyond pivotal Phase III data readouts.
  • Manufacturing Readiness: A GMP-compliant facility in Northbridge, MA is operational and capable of producing over 1 million DuraVu treatments annually, with U.S.-sourced API to mitigate tariff risks.
AI Generated. May Contain Errors.
Earnings Conference Call
EyePoint Pharmaceuticals Q1 2025
00:00 / 00:00

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