Good afternoon, and welcome to Tarsus Investor Call announcing the acquisition of iRenix Medical, Inc. As a reminder, this call is being recorded and all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. At this time, I would like to turn the call over to David Nakasone, Head of Investor Relations, to lead off the call. David, you may begin.
Thank you. Before we begin, I encourage everyone to visit the Investors section of the Tarsus website to view the press release and related materials we will be discussing today. Joining me on the call this afternoon are Bobby Azamian, our Chief Executive Officer and Chairman. Liz Yoo, our Chief Medical Officer. Aziz Mottiwala, our Chief Commercial Officer. Jeff Farrow, our Chief Financial Officer and Chief Strategy Officer.
Joining us for the question and answer session, Neera Clase , Senior Vice President, Market Access and Reimbursement. I'd like to draw your attention to slide three, which contains our forward-looking statements. During this call, we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors contained in our SEC filings for additional details. With that, I'll turn the call over to Bobby.
Thank you, Dave. Thank you to everyone joining us today. Today's announcement marks an important milestone in the evolution of Tarsus as we continue building a leading eye care company. With XDEMVY, we demonstrated that some of the greatest opportunities in eye care come from solving significant problems that have been overlooked for decades, despite their impact on patients. Today's acquisition extends that approach to another important unmet need in eye care.
IRX-101 is a late-stage investigational ocular surface antiseptic, with the potential to improve the standard of care for millions of patients who require repeated retinal procedures to preserve their vision. Additionally, it represents the next step in expanding our pipeline, broadening our impact across eye care, and establishing our first strategic position in retina, one of the largest and most important specialties in eye care.
In many ways, our first step into the back of the eye begins by addressing an impactful problem at the front of the eye, the ocular surface, where we have deep expertise. It also reflects how we think about innovation. Start with what matters most to patients and physicians, understand and address the root cause of the burden, and bring forward solutions that have the potential to fundamentally transform patient outcomes.
One of the many reasons we're excited about this acquisition is the scale of the need. More than 11 million intravitreal or IVT injections are performed each year in the United States. Many patients return every four to eight weeks, often for years, to preserve their vision. Yet one of the most fundamental parts of the procedure, antiseptic preparation before the injection, has not seen any meaningful innovation in more than 40 years.
With IRX-101, we believe we have the opportunity to substantially improve the patient treatment experience and outcomes, making it easier for patients to continue sight-preserving treatment while also reducing the burden for physicians. Before I hand the call over to Dr. Liz Yoo, our Chief Medical Officer, I want to acknowledge Dr. Stephen Smith, co-founder and CEO of iRenix, a vitreo retinal surgeon and clinical assistant professor of ophthalmology at Stanford.
Stephen understands this problem firsthand from treating retinal patients, and he and the entire iRenix team built IRX-101 with a clear focus on improving the IVT injection experience. We are grateful for the innovation, passion, and patient focus they brought to this program, and we are honored that they have entrusted Tarsus to carry this forward. With that, I will turn the call over to Liz.
Thank you, Bobby, and good afternoon, everyone. As many know, I've spent my career as a practicing ophthalmologist, helping patients restore and preserve their vision, often through ongoing treatment. Echoing Bobby's comments, I'm thrilled with the acquisition of IRX-101 because it has the potential to address the significant shortcomings of a critical part of every intravitreal injection, the application of povidone-iodine before the injection.
When I talk with my retinal specialist colleagues, they tell me one of the biggest complaints they hear from the patients is the burning, irritation, and pain that can follow antiseptic preparation. Our own survey results confirmed exactly that. More than three-quarters of retinal specialists we surveyed attributed patient complaints to povidone-iodine. Not the needle, povidone-iodine. For patients with retinal disease, treatment doesn't end with a single injection. They often return every four to eight weeks for years to preserve their vision.
When a povidone-iodine application is followed by ocular surface damage causing corneal epithelial cell death, it can lead to days of pain and irritation, and that burden can accumulate over time. As a clinician, I've seen firsthand how it can make patients more reluctant to return for ongoing care. That's why improving the patient experience is so important, and that's what makes IRX-101 so compelling.
Turning now to the data. In the iRenix RELIEF phase II-B/III trial, IRX-101 was compared directly against povidone-iodine in patients undergoing intravitreal injections. In this study, IRX-101 demonstrated statistically significant improvements in both endpoints, post-procedural pain and corneal fluorescein staining, a test showing damage to the ocular surface. Furthermore, approximately half of patients treated with IRX-101 reported a pain score of zero one hour after their procedure. Not lower pain, but no pain.
Looking ahead, the pivotal phase III study has a defined path forward aligned with input from the FDA, and we anticipate initiating this study in the first half of 2027. We plan to enroll approximately 270 patients and compare directly against povidone-iodine with top-line data expected in 2028. The path is clear and the need is significant. We look forward to advancing this program and the potential to deliver a new patient-centric option that can benefit physicians and patients alike. I'll now turn the call over to Aziz.
Thank you, Liz. Hearing that perspective from someone who treats these patients every day reinforces exactly why this asset has the potential to be so impactful. The success of XDEMVY has given us much more than a product on a path towards more than $2 billion in peak U.S. sales. It has given us a proven commercial engine, one built on strong clinical evidence, physician education, broad patient access, and exceptional execution.
We've demonstrated that we can change physician behavior, build lasting relationships across eye care, and successfully bring an innovative therapy to patients. We believe IRX-101 is another opportunity where those capabilities matter. Commercially, this is an attractive opportunity because it's a highly focused market that already exists. More than 11 million IVT injections are performed every year in the U.S., and every one of those procedures requires an ocular antiseptic preparation.
The vast majority of those procedures are performed by approximately 3,500 retinal specialists, which means we have the opportunity to build a dedicated, focused commercial effort, including a sales force that is expected to be less than half the size of our current XDEMVY sales force. We don't need to create demand.
We need to facilitate adoption through education that demonstrates meaningful value to retinal specialists and the patients they care for. We believe our commercial capabilities, combined with a differentiated product, position us to do exactly that. I'll now turn it over to Jeff to highlight the details of the transaction.
Thank you, Aziz, and good afternoon, everyone. When we evaluated this opportunity, we focused on three things. A large and durable market with significant unmet need. Second, a differentiated late-stage asset with a clear regulatory path, and a transaction structure that reflects efficient capital allocation. The iRenix acquisition ticks all of the right boxes.
It advances our long-term strategy to build a leading eye care company while preserving the financial strength to continue investing in XDEMVY and our broader pipeline. It also represents a thoughtful use of capital that has the potential to create meaningful long-term value for shareholders. Let me now walk you through the transaction structure.
Under the terms of the acquisition agreement, Tarsus will pay upfront consideration of approximately $75 million, consisting of $37.5 million in cash and $37.5 million worth of Tarsus common stock, and potential approval and commercial milestones of up to $490 million and low to mid-single digit tiered royalties upon achievement of certain milestones. I'm pleased to announce that the acquisition has closed, and we have financed the purchase with our balance sheet.
From a financial perspective, what makes this opportunity particularly compelling is the combination of a well-defined development program, a focused commercial model, and a transaction structure that aligns significant portions of the economics with future value creation. This asset is also supported by an attractive intellectual property position with patent protection expected into at least 2039. As Liz outlined, the pivotal study is expected to initiate in the first half of 2027, with top-line data expected in 2028.
We anticipate the cost to approve it to be in the range of approximately $20 million-$30 million. Stepping back, this transaction is about much more than adding a promising late-stage asset. It allows us to leverage the capabilities we've built with XDEMVY from clinical development and commercial execution to market access as we thoughtfully expand into one of the largest specialties in eye care.
At the same time, we're doing so from a position of financial strength while preserving our ability to continue investing in XDEMVY and the rest of our pipeline. We believe that combination, strategic expansion, focused execution, and financial flexibility positions Tarsus to create meaningful long-term value for patients, physicians, and shareholders. I'll now hand the call back to Bobby for closing remarks.
Thanks, Jeff. We've always said our ambition is to build a leading eye care company. Now we've taken another important step forward. With XDEMVY, we proved that meaningful innovation can transform areas of eye care that have been overlooked for far too long. IRX-101 provides us the opportunity to do it again, bring meaningful innovation to millions of patients while establishing the foundation for our next chapter of growth. Operator, please open the line for questions.
Thank you. Ladies and gentlemen, to ask the question, please press star one one on your telephone, then wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Jason Gerberry with Bank of America. Your line is open.
Hey, guys. Thanks for taking my questions. A couple from me. What do you need to show to command a price premium versus Betadine, which I understand to be more at a genericized price point per bottle? Is this a category where you think you can get a price premium with good access if you deliver on the remaining outstanding phase III trial requirements?
As it pertains to the upcoming phase III, the press release suggests this is like a safety tolerability trial. Can you just remind us, what are the endpoints, treatment duration? What are you looking to show in this type of trial? Is this really about showing a comparable antiseptic benefit to Betadine? Thanks.
Hey, Jason. It's Aziz, thank you for jumping on. Really great questions here. I'll start with just talking about why we're excited about the market opportunity, right? To reiterate, 11 million IVTs every year in the U.S. These are patients that are undergoing therapy to save their vision, that process really matters, and all of them get antiseptic. This is a critical step in that process.
In terms of your question, we see this as being a very differentiated asset, when it pertains to pricing reimbursement, this is an area that we actually are really keen on. To that end, we've had Nira Claes, who's our head of access, join us here today, she's the architect of all the market access and reimbursement work we've done at XDEMVY, which, as everyone knows, has been a core pillar of the success of that launch.
I'll allow Nira to give you a little bit more color on what do we think it'll take to get that differentiated reimbursement, then maybe we can turn it over to Liz to give you a little bit more color on the clinical plan there. Nira, I'll turn to you.
Great. Hi, Jason. In terms of the pricing, it's early days, as you know now. We don't have pricing yet established, but we do and will pursue the J-code pathway. Typically, how it works for a product like this is that this is a buy and bill product because it's physician administered. What that means is that there's typically a miscellaneous code that's assigned, with that, it will go through a process where at some point we'll pursue the J-code. We feel really confident about the J-code strategy, once we determine the strategy and the approach, we'll also get more firm on the pricing as well.
That will all be driven by the clinical insights, and we do feel like there's a strong clinical differentiation here given the TAM that you've heard Aziz Mottiwala talk about, as well as the opportunity to really differentiate from a current product that causes a lot of pain, a lot of discomfort, and actual corneal toxicity. With that, I'll turn it over to Liz to talk a little bit more about the clinical value.
Hey, Jason. Thanks for your question regarding the pivotal study. You're absolutely right as it comes to the phase III study. It is a pivotal safety study. The name is COMFORT. With that, we will also explore various endpoints to potentially enhance the label for use over the current standard of care. That will also reinforce the earlier findings of the potential pain improvement, as well as the staining over povidone-iodine. The FDA separately will require an efficacy study in order to obtain the antisepsis label. We will run those two studies in parallel.
Just to clarify, the efficacy study is in vitro antimicrobial study, that's also something that's pretty standard and lower risk as it pertains to a late-stage study.
Okay, great. Thanks.
Thank you. Please stand by for our next question. Our next question comes from the line of Dennis Ding with Jefferies. Your line is open.
Hi, thanks for taking our questions. Can you please clarify what's really the deciding factor here for adoption? Is it reduced pain or reduced infection rates and subsequent corneal damage? It's not a product that a patient's going to request, so it's going to be up to the doctor to reach for this over a generic product. Maybe the answer here is the ASP plus 6%. Curious what you guys are thinking around how you're going to pitch this to doctors, and are patients really going to come back more frequently due to less pain? Thanks.
Thank you so much for that question. I believe the opportunity is the improved patient experience. IRX-101 is really a novel ocular antiseptic. It is a chlorine dioxide solution that specifically targets the bacterial cell wall. It improves the potential for just cell damage to the microbial killing itself. It's unlike povidone-iodine, which is nonspecific and really broadly toxic, whereas IRX-101 is targeted cell killing, so it induces less cell damage.
44% of patients after their third intravitreal injections will actually stop going and stop receiving their injections. They actually have decreased compliance because of the anxiety and the pain that is produced by these retinal injections. The opportunity here is that with improving and the actual experience themselves, we can redefine the standard of care here.
I would just add, Liz, great point on the science here, and also reiterating the point you made earlier that the three-quarters of the doctors we talk to tell us the biggest issue that patients have is actually the antiseptic preparation with Betadine, not even the needle. These are patients receiving injections in the eye, and they're actually complaining about the procedure preparation.
You're right, this is not going to be something that patients are going to ask for by name like XDEMVY, but this is something the doctors are going to reach for because they want to optimize that experience for the patient. They want to make sure the patients are happy, and most importantly, as Liz just highlighted, they want to make sure that process is conducive to the patient staying on therapy. This is therapy to preserve their vision.
It's very important that process is conducive to the patient staying in the practice, staying adherent, and being comfortable in what would otherwise be a very difficult management process. There's a lot of meat on the bone there. As you can imagine, we've got a really strong strategy in terms of how to educate the physicians, the implications that are going to be there. Nira talked earlier about the access model that we can have. These are all things that we've done really well with XDEMVY, and we believe we can replicate with IRX-101 quite effectively.
Got it. Thank you.
Thank you. Our next question comes from the line of Matthew Caufield with H.C. Wainwright. Your line is open.
Hi, guys. Thank you. Just to follow up on what's already been answered, is the IRX-101 goal to offer an alternative for those patients that have already experienced discomfort from previous procedures or potentially replace the traditional povidone-iodine kind of more broadly? Then just separately, just to confirm, with the IRX-101 phase III initiation targeted for first half of 2027, that does not impact any of the prioritization for TP-04 in ocular rosacea or the TP-05 development in Lyme disease next steps, correct? Thanks a lot.
No, this is Bobby. Then I'll pass to Aziz and Liz for the first one. Certainly, this does not impact our R&D capacity and our timelines on other pipeline programs. If anything, as has been mentioned, this really doubles down our category-creating formula. I'm personally excited about this one because it's a great way to help patients preserve vision, as Aziz and Liz had mentioned. Different program, different indication, and we have the capacity and the wherewithal to do it. I'll pass to Liz and Aziz to talk about IRX-101 and the alternative it might offer to Betadine.
I'll start, just talk about the market opportunity. I think it's a great question. Obviously, with such a differentiated profile and the market we're looking at, we do see this as an opportunity to change the standard of care. While today we're not going to be talking about peak sales potential, I think you can illustrate what some obvious use cases are to start.
About a third of patients coming in have real high degrees of Betadine sensitivity, meaning they can't even tolerate it at all. That's going to be the obvious first use case. While we are going to look for changing the standard of care, we're going to be really thoughtful about starting. If you look at just those third of patients that can't tolerate Betadine at all, that would be where the doctors will reach for this first.
A conservative starting point, if you're thinking about how to model this is, that alone would be a $2 million- $300 million market potential opportunity. More to come there as we continue to do the market development, but we see clear starting points and clear opportunities to change the standard of care. Maybe, Liz, you can highlight from a physician's perspective why the science and rationale clinically would support that.
Absolutely. As Aziz mentioned, povidone-iodine remains the long standard of care for antiseptic preparation. There's no other commercially available ocular antiseptic. The alternative, like aqueous chlorhexidine, exists, but it's really only used when povidone-iodine is not tolerated or there's a documented hypersensitivity. Even with povidone-iodine, it is a non-standard way that it is utilized.
What makes IRX-101 so compelling is that rather than adapting an existing antiseptic for the setting, we're developing with IRX-101 a specific ophthalmic use for intravitreal injections with prospective clinical data that'll be generated directly against Betadine in order for retinal specialists with a purpose-built product that will be head to head with more comfort as well as less staining and ultimately a better experience for the patient.
Understood. Very helpful. I appreciate all of that. Thank you.
Thank you. Please stand by for our next question. Our next question comes from the line of Graig Suvannavejh with Mizuho. Your line is open.
Good afternoon. Thanks for taking my questions. Congrats on the deal. Obviously, this is a product and profile of a product that we've not really seen before, so appreciate the color that you've given on an initial view of the market opportunity. With that said, as I think about on the forward with your current pipeline and now adding this product, can you talk about what the BD strategy is from here? I know you guys have been looking at a lot of different things. Does this kind of make you feel that you're in a good spot, or is there the potential that we should be looking for additional deals whether it be this year or next year, or should we be expecting a certain cadence?
Hi, Graig, it's Jeff. Happy to answer that question. Yeah, we're really excited about this deal, but we do continue to strive to be an eye care leader and having more pipeline value be created through our existing programs, but also through BD. We're continuing to explore additional opportunities in the anterior segment and As highlighted by Bobby, this is kind of our first foray into the back of the eye. We're expanding our lens to look at other products in the back of the eye. These are not your typical sort of wet AMD type of products, but rather unique category-creating aspects that we think we can create value and provide some incremental benefit to the patient community as well.
Thanks, Jeff, maybe a follow-up for you. Just on the deal terms, I know that there are $490 million in approval and commercial milestones. Any additional color you could give just on how, as we think about our model, kind of is this where the economics on those milestones are more back-end loaded, or are they more front-end loaded, related more to approval?
Yeah, happy to provide some context there. The milestones are all based, start happening on approval and are commercial-based milestones. From an accounting perspective, the upfront payment of $75 million will be expensed in the third quarter. As the milestones are achieved, they'll be capitalized and amortized over the life of the patent. That'll be sort of how to think about it from an accounting perspective.
All right. Thanks so much. Congrats again.
Thank you.
Thank you. Please stand by for our next question. Our next question comes to the line of François Brisebois with LifeSci Capital. Your line is open.
Hi. Thanks for taking our questions. This is Dan on for Frank. If you could just touch on, are there any sort of differences in workflow in terms of preparation administration compared to Betadine for IRX-101, and how do you see sort of physicians viewing it positively for adoption?
Hi, this is Liz here. Yeah, with IRX-101, as you saw in the photos, it's an easy two-part system that's activated by a buffer, and it takes less than a minute to put together. What I envision as an eye care professional is that this will be a potentially real easy, standardized approach that could be streamlined right into the workflow for the intravitreal injection process, as compared to what povidone-iodine currently is doing, where it's non-standardized. Some people use swabs, others use gauzes, and there are different concentrations that are currently being utilized.
Thank you.
Please stand by for our next question. Our next question comes from the line of Truman Dunkley with William Blair. Your line is open.
Hi, this is Truman for Lachlan Hanbury-Brown. I was wondering, are there additional investments that will be needed to support any commercial infrastructure needs?
Yeah, I can start there. When you look at the commercial infrastructure needs, certainly we'd build out specific commercial efforts for this product to maximize the opportunity here. What's exciting is, in addition to a very large TAM established need in the marketplace, it's a pretty focused effort, right? When you think about the retina space, about 3,500 doctors make up the vast majority of injections that are done.
As we said, we'd have a focused commercial effort. Sales team here would be probably about half the size of the XDEMVY sales force dedicated specifically to the retinal specialist. That's a little bit of an incremental build-out, but it's a very focused build. We'll be able to take full advantage of all of our other efforts, marketing, back office, conference support.
There's some synergies here when you think about us being a commercial player in eye care, certainly. Obviously with a very unique and differentiated product, we are going to be making strategic investments to maximize that differentiated offering and really cultivate deep relationships with the physicians that will adopt this product.