Tarsus Pharmaceuticals, Inc. (TARS) Earnings Call Transcript & Summary

Hello, and welcome to Tarsus Pharmaceuticals Second Quarter 2026 Financial Results Conference Call and announcement to acquire Alkeus Pharmaceuticals. As a reminder, this call is being recorded. [Operator Instructions] At this time, I would like to turn the call over to Sarah Nives, Investor Relations, to lead off the call.

Thank you. Before we begin, I encourage everyone to visit the Investors section of the Tarsus website to view the press releases issued today and related materials we will be discussing today. Joining me on the call are Bobby Azamian, our Chief Executive Officer and Chairman; Neera Clase, our Interim Chief Commercial Officer; Sesha Neervannan, our Chief Operating Officer; and Jeff Farrow, our Chief Financial Officer and Chief Strategy Officer. And joining us for Q&A is Dr. Liz Yeu, our Chief Medical Officer. I'd like to draw your attention to Slide 3, 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.

Hello, and thank you for joining us. Today is an important day for Tarsus. We're reporting another exceptional quarter for XDEMVY and announcing the acquisition of Alkeus Pharmaceuticals and gildeuretinol or ALK-001, a late-stage investigational therapy for Stargardt disease. When we launched XDEMVY, we believed Demodex blepharitis or DB was one of the largest diseases in eye care, hiding in plain sight. Our ambition was never simply to commercialize a single medicine. It was to demonstrate that by identifying diseases that have been overlooked for years, creating categories, developing medicines with the potential to redefine the standard of care and executing with excellence, we can fundamentally change patient care while building a leading eye care company. XDEMVY continues to prove that thesis. Nearly 3 years after launch, more than 700,000 patients have been treated. XDEMVY has generated almost $1 billion in net product sales reported to date, and we are well on our way to over $2 billion in potential annual peak sales. This quarter alone, XDEMVY generated approximately $174 million in net product sales, representing more than 69% year-over-year growth. XDEMVY has never been stronger, and we believe we are still in the early stages of realizing its full commercial opportunity. What's more, XDEMVY is powering innovation at Tarsus, and that's precisely why we have the confidence to make strategic investments like the one we are announcing today. We are investing in assets with novel disease-modifying approaches, compelling clinical evidence and a clear strategic fit to build a leading eye care company. ALK-001 is exactly that as it has the potential to preserve vision for longer and become a foundational treatment for Stargardt disease. This devastating inherited retinal disease often affects children and young adults. And today, there are no FDA-approved treatment options. It also broadens our presence in retina, one of the largest and most important specialties in eye care. We've already begun building capabilities through our recent acquisition of IRX-101 and aim to create a distinct portfolio positioned to address serious retinal diseases over time. I would like to take a moment and thank the Alkeus team for all their passion and commitment in developing ALK-001, a truly novel medicine. To date, they have developed one of the most robust clinical data sets, and we believe ALK-001 has the potential to preserve vision longer in patients suffering from Stargardt disease. XDEMVY remains a cornerstone from which we're building a leading eye care company, one with the capability, pipeline and innovation to repeatedly bring meaningful medicines to patients. And with today's announcement, we took an important step on this journey. This acquisition is expected to build upon the commercial success of XDEMVY and with the addition of ALK-001, creates one of the most exciting pipelines in eye care and beyond, one that is positioned to deliver multiple potential blockbuster medicines over the next several years. Before I turn the call over, I would like to welcome Neera Clase, our Interim Chief Commercial Officer, to her first earnings call. Neera has been instrumental in building our commercial organization and ensuring the ongoing success of XDEMVY, and we are thrilled to apply her leadership and expertise to this new chapter. Neera, over to you.

Thank you, Bobby. I'm honored to step into this role at such an exciting time for Tarsus, and I look forward to advancing the playbook that has put XDEMVY on the path to more than $2 billion in potential peak sales. As Bobby mentioned, XDEMVY is the cornerstone of our company and across every metric that matters, eye care professional adoption, consumer activation and commercial execution, the business has never been stronger. These 3 priorities are reinforcing one another, which is exactly why XDEMVY continues to outperform. The clearest evidence is the change we're seeing in ECP behavior. I recently spent time in the field hearing firsthand from doctors about how the conversation around DB has evolved. Eye care professionals or ECPs are no longer asking whether they should treat DB, they're asking how broadly they should be screening for it and how many more patients can they treat. And the numbers reinforce the acceleration we are seeing. Over the past year, the number of ECPs prescribing XDEMVY at a near daily cadence has doubled, and our top doctors have continued to increase prescribing month after month. That's an important shift. It signals that the market has moved beyond initial adoption and towards the standard of care. We are also seeing retreatment rates advance into the high teens, creating an increasing source of demand alongside new patient prescriptions. Combined with broader ECP adoption, that gives us even greater confidence in the long-term trajectory of the business. Our growing body of clinical evidence is also helping to deepen that conviction. Recent studies have shown that DB is common in patients with Thelazia, which further reinforces XDEMVY as the standard of care over tea tree oil and highlights the potential infection risk associated with Demodex and bacterial coinfestation. Together, these findings are encouraging ECPs to screen more consistently during routine eye exams and identify patients with DB they may not have diagnosed previously. In addition, our key account leaders or KALs, are now fully deployed across their highest potential practices. They are helping those practices embed screening more consistently, identify more patients and expand treatment over time. And the field feedback I'm hearing was echoed in a recent survey of these same doctors. More than 80% of physicians told us that they expect to increase XDEMVY prescribing over the next year and beyond. This strongly signals continued momentum as we work to reach the estimated 25 million Americans living with DB. While ECP behavior is deepening the market, our consumer efforts are expanding the top of the funnel. Our consumer campaigns are introducing millions of people to a disease that they never heard of. John Cena, our celebrity spokesperson, brings credibility and authenticity through his own experience with DB, while our new unbranded DTC campaign featuring Barry the Cat helps patients recognize symptoms in a way that's approachable, memorable and easy to understand. As a result of these efforts, many patients are now asking for XDEMVY by name. We've also seen a 19% increase in high-value actions on the XDEMVY.com website, including the use of our Find a Doctor tool and lastly, our AI-powered concierge, which helps patients better understand their symptoms and take the next step with their ECP. Unaided awareness of DB has also climbed to approximately 30%, which is remarkable when you think about how far we've come since we first launched our DTC campaign. The response has been powerful and clearly resonates with patients. They aren't simply hearing the message, they're becoming educated, engaged and motivated to seek care. Our commercial pillars are working in concert just the way we envisioned. Greater awareness brings more and more patients into eye care practices, stronger evidence and field execution help physicians identify and treat more patients and positive clinical experience further reinforces confidence and adoption. When I look at the business today, I see a potential $2 billion opportunity that is unfolding exactly as we planned. That's why my confidence in XDEMVY has never been stronger. Its continued success is not only driving growth, it is creating the foundation for Tarsus to invest in programs like gildeuretinol and expand our impact for patients across eye care. With that, I'll turn it over to Sesha.

Thank you, Neera. This is a momentous day for Tarsus and our mission to serve patients. We believe ALK-001 is the most compelling program in development for Stargardt disease. And as you heard from Bobby, it has the potential to become a foundational medicine for patients with no approved therapies today. Stargardt is a serious inherited retinal disease that often begins in childhood or adolescents with more than 36,000 diagnosed patients and a total estimated 86,000 patients in the United States. Vitamin A is essential for healthy vision and is a key component of the visual cycle. Stargardt is caused by a genetic mutation that leads to formation of toxic vitamin A dimers known as bisretinoids. These toxic dimers can damage the retinal cells responsible for central vision and over time can cause blindness. The consequences can be devastating. Half of patients diagnosed before age of 20 are expected to become legally blind within 7 years, 7 years. That's a reality facing many children and young adults living with Stargardt disease today, and it's also the urgency for this program. ALK-001 is an investigational modified vitamin A analog designed to slow the formation of these toxic byproducts while preserving the normal visual cycle. It has the potential to address the dimensions that matter most to patients, slowing the progression of a blinding disease and preserving visual function. To date, the program has generated encouraging evidence of visual function preservation with no evidence of negative treatment-related effects on night vision, dark adaptation or color vision. As you can see here, the TEASE studies showed ALK-001's potential to preserve the visual cycle and acuity, slow retinal atrophy and its unmatched long-term tolerability profile. Together, these studies give us confidence that ALK-001 can be a breakthrough medicine that can potentially prevent the progression of Stargardt disease. As with any chronic therapy, especially one that impacts pediatric and adolescent patients that may ultimately be taken for a lifetime, the long-term safety profile is paramount. ALK-001 has been evaluated in more than 400 patients, demonstrating a favorable tolerability profile and with treatment exposure extending up to 7 years. This is exactly the type of program we look for, differentiated disease-modifying approach, compelling long-term tolerability and a potential to meaningfully alter the course of the disease for patients with no approved treatment options today. Turning to next steps in the program. NORTHSTAR, the ongoing Phase III study is designed to demonstrate that ALK-001 can slow disease progression in patients with Stargardt disease. The study is expected to enroll approximately 230 patients between ages of 8 and 45. The primary endpoint will measure the rate of retinal lesion growth over 24 months, and the secondary endpoint will assess a key aspect of visual function, change in low-luminescence visual acuity. Coupled with the compelling data from these trials, ALK-001 is expected to generate a differentiated and the most robust clinical data set in Stargardt disease. The program has been developed with the FDA, and we anticipate top line results in the second half of 2029. We are also considering a potential second Phase III trial to support approval. The trial to be discussed with the FDA is envisioned to focus on younger and faster progressors and include additional exploratory endpoints. We believe ALK-001 has the potential to become a foundational treatment for patients with Stargardt disease, one which can blind a child within 7 years. ALK-001 is a differentiated disease-modifying medicine that protects the retina without impacting the normal visual cycle. It advances our pipeline in retina and most importantly, gives these patients something they have never had, an investigational medicine with the potential to meaningfully slow progression of this blinding disease. Jeff, over to you.

Thank you, Sesha, and good morning, everyone. All around, this was another outstanding quarter for Tarsus. We delivered record XDEMVY revenue, continue expanding our leadership in eye care and another important step in our long-term growth strategy through the acquisition of iRenix and today's announced pending acquisition of Alkeus. In the second quarter, XDEMVY net product sales were $173.9 million, representing more than 69% growth year-over-year and approximately 20% growth quarter-over-quarter. Gross margins were flat at approximately 93%, and we ended the quarter with cash, cash equivalents and marketable securities of $449.7 million. For additional details on our Q2 financial performance, please refer to the earnings release we issued today. Turning to guidance. We have updated our outlook for the remainder of 2026 and increased XDEMVY full year net product sales guidance to $685 million to $705 million from our prior guidance of $670 million to $700 million. This increase reflects our confidence in the underlying strength of the business. As we have previously discussed, we expect the quarterly revenue progression throughout the remainder of the year to reflect normal seasonality in the eye care market. The summer period typically includes fewer physician office delayed case due to vacations, holidays and conferences, and we expect tempered growth in the [Technical Difficulty]. We then expect more robust growth in the fourth quarter, supported by the usual year-end patient dynamics, and this cadence is reflected in our increased full year guidance. Moving to operating expenses. We continue to expect gross margins of approximately 93% and SG&A expenses of $545 million to $565 million. We now expect full year R&D expense to be in the range of $190 million to $210 million, an increase from our previous guidance of $115 million to $135 million. The increase reflects the upfront consideration of $75 million for the acquisition of iRenix Medical. This guidance does not include the pending acquisition of Alkeus. Turning to the financial terms of the Alkeus transaction. The upfront consideration is $450 million, consisting of $270 million in cash and $180 million in Tarsus common stock. The transaction includes up to $350 million in potential milestones like a regulatory approval in the United States and the first commercial sale as well as low single-digit tiered decreasing royalties on future net sales. In addition, we secured $125 million through a private placement financing from a syndicate of leading health care investors, including several shareholders of Alkeus. This transaction reflects the disciplined [Technical Difficulty], which we've discussed with investors over the past several years. We're investing from a position of strength while maintaining the financial flexibility to continue executing on XDEMVY and advancing our broader pipeline. The Alkeus transaction is expected to close later this year, subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. Financially, this transaction strengthens our long-term growth profile while remaining consistent with our strategic approach to capital allocation. It expands our presence in retina and adds a differentiated late-stage program with significant potential. [Technical Difficulty] the entire Tarsus team, it represents a significant and potentially transformative opportunity to help patients, particularly children and adolescents, maintain vision longer by slowing the progression of this blinding disease. We look forward to updating you as the transaction progresses. With that, I'll turn the call back to Bobby.

Thank you, Jeff. Before we open the lines this morning, let me leave you with one final thought. Everything we've talked about today starts with XDEMVY. Its success has changed the standard of eye care, created extraordinary momentum for our business and most importantly, what's possible for Tarsus. Today's announcement is another important step in that journey. Together with our other retina acquisition, IRX-101, strengthens our retina portfolio and reinforces our mission to build one of the most innovative and differentiated companies in eye care. We're incredibly excited about the opportunity ahead. Operator, please open the line for questions.

[Operator Instructions] And our first question comes from Graig Suvannavejh of Mizuho.

This is Ryan Ries on today for Graig Suvannavejh. Just wanted to ask a little bit about the new asset and how you see it comparing an efficacy to tinlarebant, the Stargardt medication in Phase III trials for Belite, which has a head start. Is there any differentiating factor that you think could help [indiscernible] to capture more market share relative to tinlarebant?

Thank you, Ryan. Yes, this is Bobby. We're really excited about this asset. As mentioned, we are really serving the landscape and found a very compelling late-stage opportunity. And we understand that we're likely going to second here. And we're still very compelled by this. So in terms of overall profile, we see something that can really change the course of this disease that demonstrated effectiveness in a couple of dimensions that are really important patients, both the progression of disease is measured by atrophy and the progression of disease measured by visual acuity, low-light visual acuity in particular. And that's unique in this field. We have to see a great safety profile with up to 7 years of data over 400 patients treated. So we think that presents a compelling opportunity. I'll pass to our Chief Operating Officer, Sesha, to talk a little bit more about that profile, and we can certainly dig deeper here over the course of the call.

Thank you, Bobby, and thanks for the question, Graig (sic) [ Ryan ]. As I mentioned in the prepared remarks, gildeuretinol or ALK-001 is a medicine that has been designed to reduce or curtail the toxic dimers in the eye without impacting the visual cycle. That's a very key gating factor for us with this particular molecule and this particular mechanism. Toxic dimers are the key cause of retinal cell death. And we also want to make sure that the vitamin A visual -- participation in the visual cycle is not put up. And that's precisely what this medicine does. And it's actually shown in the data that we don't see any night vision adaptation or color disturbances and a very good safety and tolerability profile. So we think this medicine will differentiate itself on those properties and it's very important for the patient, especially in a blinding disease to not impact the visual size.

And Ryan, maybe I'll add -- this is Jeff. Just did some market research on what Sesha just highlighted there, seeing structural benefit, functional benefit with LLVA and just a really nice safety profile. And we surveyed about 100 retinal docs. And based on that, we really think that this is a $1 billion-plus opportunity based on that -- by that differentiation there.

And our next question comes from Eddie Hickman of Guggenheim Securities.

Congrats on all the progress in the deal. So now that you're building towards 2 retina launches sort of on different time lines, can you talk about the difference in sort of call points that you need to sort of build out and sort of how we should think about the sequencing of that commercial build in terms of size and scope? Appreciate it.

Thank you. Yes, Eddie, I'll start, and I'll pass to our Chief Commercial Officer, Neera. So it's a great point. We're entering a new field, retina. We're really excited to have now 2 Phase III drugs. I'd kind of go back to 6 years ago when we were at that same stage with XDEMVY, and we took a very diligent approach to understanding the eye care provider and really educating. And I know we'll do that here as well. So we have 2 drugs in Phase III, one IRX-101 is a little bit ahead of ALK-001. So I think it positions us well. And I'll pass to Neera to talk about some of the synergies she see.

Yes. Thank you, Bobby. We believe both of these assets are a great commercial fit for Tarsus, really helps us to build the pipeline to become that broad eye care leader. And it plays exactly to what we've been doing with XDEMVY. And here are a couple of reasons why because we're still servicing an underserved population with a high unmet need, we'll plan to deliver evidence to differentiate the science. And what's different here in terms of the call point is we're talking about a more concentrated physician base about 3,500 of the physicians out there today. And our focus will be on securing broad access and launching efficiently into a concentrated physician audience. So it's a different playbook from the DB, but very similar footprint. And as you know, we've proven that we can execute, and we're really excited about this opportunity.

And the other thing I'd point out is there's a lot of lads in the call here. So it's about 500 doctors will be serving with IRX-101, that are doing ITs and then a subset of those actually 2,000 are prescribing, we think we're likely to prescribe over 80% of the Stargardt therapies here. So that presents some real synergy in terms of the sales force itself that we'll be building here.

Got it. And in terms of access, is that the same time line as XDEMVY in terms of sort of getting payer reimbursement set up? Should we think about it the same as XDEMVY? Or is it different for this space?

Different in that it's rare, but very similar in terms of how we've gone about access, right, a differentiated value story, but very comparable in terms of fast access, broad access.

The other thing -- I'll have Liz Yeu, our CMO, talk about, we're front of the eye company, and this is often where patients with Stargardt present. So Liz, you might speak to your experience and how you see kind of the initial assessment in the eye care provider landscape here.

Thank you, Bobby. When we think about the patients that we're taking care of, certainly, I'm taking a view of it from the patient perspective. And while most of the diseases that we see as eye care providers see, they worsen aging what's so unique and so humbling about Stargardt's disease is that almost half the patient population are actually kids and adolescents. And of those who are the fastest progressors, half of them actually go blind within 7 years. So the opportunity for us to be able to manage them together alongside a lot of patients who are getting seen, especially those who are younger, they may complain or fail vision test at school, but it's going to be more primed by those primary eye care physicians who are seeing them because of those complaints, failed vision test or because they're coming in with glasses will be then diagnosed by the retina specialists. But it will be a shared opportunity. So there is that, yes, we have the blueprint of the education and the evidence generation. But the retina doctors, it is a small subset that we will definitely extend, leverage the relationships, educate and certainly generate the evidence.

And our next question comes from Jason Gerberry of Bank of America.

I'm just trying to think about just, a, the market opportunity here. I think you said something like 30-some thousand patients. Belite's talked about a pricing in the $350,000 to $500,000 territory. So trying to get a sense of what proportion of these patients are actually under the care of like a retinal specialist and is an addressable sort of market? Secondly, just a question around how to think about like sort of the use of natural history. So like on BCVA changes over, say, a 2-year period versus lesion growth, I think the competitor had flagged you typically would lose like 1 letter every 2 years or so. So just wondering how you think about like the need for longer-term follow-up and sort of the durable BCVA benefit.

Yes. Thank you for your question. In terms of pricing, that price range that you articulated is the price range that we would consider also for this asset around that $350,000 price point. And it's really about value creation, understanding the differentiated profile here. And as we think about this particular asset, there is a safety and tolerability value proposition that really resonates here and differentiates from the competition. So we're excited to launch this. And as you mentioned, the natural history is a good way to create that value over time and to position this for optimal dosing and durability. With that, I'll turn it over to Sesha to provide additional comments.