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Investor releaseQuarter not tagged2026-08-13Tarsus Pharmaceuticals (TARS) Stock Looks Reasonable On Sales While Earnings Stay Weak
Simply Wall St.
Tarsus Pharmaceuticals (TARS) Stock Looks Reasonable On Sales While Earnings Stay Weak
Track your investments for FREE with Simply Wall St, the portfolio command center trusted by over 7 million individual investors worldwide. Tarsus Pharmaceuticals stock has delivered a very large 3 year return, yet the broader valuation checks still suggest it trades on the cheap side. Recent news around acquisitions and pipeline expansion adds another layer for investors trying to judge whether the current price fairly reflects the fundamentals. Over the past 3 years the share price has returned about 3.2x, which puts extra focus on whether that move is grounded in underlying value. The acquisition of Alkeus Pharmaceuticals and progress with XDEMVY and other pipeline assets can support higher long term cash flow expectations. At the same time, ongoing losses and funding needs may limit how much investors are willing to pay today. Tarsus Pharmaceuticals screens as undervalued on 6 of 6 broader checks. That high value score suggests the stock still looks inexpensive on the core valuation metrics tracked in Simply Wall St's 6-point framework. The issue now is whether the current share price already reflects these strengths and risks or if Tarsus Pharmaceuticals still offers a meaningful margin of safety. Find out why Tarsus Pharmaceuticals' 27.2% return over the last year is lagging behind its peers. P/S tends to fit Tarsus Pharmaceuticals because revenue is already meaningful while earnings are still negative. The stock trades on a P/S of about 5.0x, which is very close to the wider Pharmaceuticals industry average of 5.0x and well below the peer group average of 13.8x. The tailored fair P/S multiple for Tarsus Pharmaceuticals is 7.8x, which reflects what investors might typically pay given its growth profile, margins, size and risk. That is higher than the current 5.0x, which indicates a discount on this measure. Despite the strong recent news flow around the Alkeus acquisition and XDEMVY sales guidance, the current P/S still implies a lower valuation than the fair ratio suggests. For investors who put more weight on sales-based metrics while the company remains loss making, Tarsus Pharmaceuticals appears attractively priced within this framework. On the P/S multiple, Tarsus Pharmaceuticals stock appears undervalued relative to both its fair ratio and many peers. See what the numbers say about this price — find out in our valuation breakdown. Simply Wall St…Read full documentShow less
Track your investments for FREE with Simply Wall St, the portfolio command center trusted by over 7 million individual investors worldwide. Tarsus Pharmaceuticals stock has delivered a very large 3 year return, yet the broader valuation checks still suggest it trades on the cheap side. Recent news around acquisitions and pipeline expansion adds another layer for investors trying to judge whether the current price fairly reflects the fundamentals. Over the past 3 years the share price has returned about 3.2x, which puts extra focus on whether that move is grounded in underlying value. The acquisition of Alkeus Pharmaceuticals and progress with XDEMVY and other pipeline assets can support higher long term cash flow expectations. At the same time, ongoing losses and funding needs may limit how much investors are willing to pay today. Tarsus Pharmaceuticals screens as undervalued on 6 of 6 broader checks. That high value score suggests the stock still looks inexpensive on the core valuation metrics tracked in Simply Wall St's 6-point framework. The issue now is whether the current share price already reflects these strengths and risks or if Tarsus Pharmaceuticals still offers a meaningful margin of safety. Find out why Tarsus Pharmaceuticals' 27.2% return over the last year is lagging behind its peers. P/S tends to fit Tarsus Pharmaceuticals because revenue is already meaningful while earnings are still negative. The stock trades on a P/S of about 5.0x, which is very close to the wider Pharmaceuticals industry average of 5.0x and well below the peer group average of 13.8x. The tailored fair P/S multiple for Tarsus Pharmaceuticals is 7.8x, which reflects what investors might typically pay given its growth profile, margins, size and risk. That is higher than the current 5.0x, which indicates a discount on this measure. Despite the strong recent news flow around the Alkeus acquisition and XDEMVY sales guidance, the current P/S still implies a lower valuation than the fair ratio suggests. For investors who put more weight on sales-based metrics while the company remains loss making, Tarsus Pharmaceuticals appears attractively priced within this framework. On the P/S multiple, Tarsus Pharmaceuticals stock appears undervalued relative to both its fair ratio and many peers. See what the numbers say about this price — find out in our valuation breakdown. Simply Wall St Narratives for Tarsus Pharmaceuticals take the valuation puzzle a step further by spelling out which future paths for Tarsus Pharmaceuticals' growth, margins and earnings would line up with a much higher or lower stock price than today. They sit on the company’s Community page. Instead of stopping at a single output from a ratio or model, they unpack the future assumptions behind that figure so you can watch how reality compares over time. One of the top community narratives on Tarsus Pharmaceuticals: 18% undervalued Read one of the top narratives on Tarsus Pharmaceuticals Do you think there's more to the story for Tarsus Pharmaceuticals? Head over to our Community to see what others are saying! Tarsus Pharmaceuticals still screens as undervalued on the market multiple view, even after a very strong three year share price move. The core question is whether the current P/S discount reflects mispricing or is simply compensation for ongoing losses and funding needs. For you as an investor, the debate now turns on how confidently you view future revenue durability from XDEMVY and the broader pipeline. The key risk is that execution or financing setbacks could justify the lower multiple, which would turn the apparent discount into more of a value trap than an opportunity. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include TARS. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-08-13Tarsus (TARS) Q2 2026 Earnings Call Transcript
Motley Fool
Tarsus (TARS) Q2 2026 Earnings Call Transcript
Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 8:30 a.m. ET Investor Relations - Sarah Nives Chief Executive Officer and Chairman - Bobak Azamian Interim Chief Commercial Officer - Neera Clase Chief Operating Officer - Seshadri Neervannan Chief Financial Officer and Chief Strategy Officer - Jeffrey S. Farrow Chief Medical Officer - Elizabeth Yeu Operator: 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. Sarah Nives: 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. Bobak Azamian: 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 fundame…Read full documentShow less
Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 8:30 a.m. ET Investor Relations - Sarah Nives Chief Executive Officer and Chairman - Bobak Azamian Interim Chief Commercial Officer - Neera Clase Chief Operating Officer - Seshadri Neervannan Chief Financial Officer and Chief Strategy Officer - Jeffrey S. Farrow Chief Medical Officer - Elizabeth Yeu Operator: 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. Sarah Nives: 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. Bobak Azamian: 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. Neera Clase: 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. Seshadri Neervannan: 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. Jeffrey S. Farrow: 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. Bobak Azamian: 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: [Operator Instructions] And our first question comes from Graig Suvannavejh of Mizuho. Ryan Ries: 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? Bobak Azamian: 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. Seshadri Neervannan: 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. Jeffrey S. Farrow: 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. Operator: And our next question comes from Eddie Hickman of Guggenheim Securities. Eddie Hickman: 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. Bobak Azamian: 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. Neera Clase: 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. Bobak Azamian: 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. Eddie Hickman: 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? Neera Clase: 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. Bobak Azamian: 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. Elizabeth Yeu: 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. Operator: And our next question comes from Jason Gerberry of Bank of America. Jason Gerberry: 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. Elizabeth Yeu: 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. Seshadri Neervannan: Yes. Thank you, Neera. So with respect to your question on long-term follow-up on the vision benefit, what we saw in the trial is that the worsening of low-light visual acuity, which is actually even more of a sensitive measure than a BCVA was statistically significant. We saw benefit within 2 years in those trials. And that is a great measure to follow up because low-light visual acuity is a precursor of BCVA loss, BCVA tends to worsen slower than LLVA. And so that's a great measure for the physicians to monitor and look at the product of vision loss. So the tools are there, and they are very mature. Operator: Our next question comes from Lachlan Hanbury-Brown of William Blair. Lachlan Hanbury-Brown: Yes. I was just wondering if the team is there. I think I cut out on that last question. Bobak Azamian: We're here. No, we're here. Lachlan Hanbury-Brown: Good. All right. Great. Congrats on the deal. I guess maybe a couple of quick ones. Just first, you've been talking a lot about the Stargardt program with gildeuretinol, but I know that Alkeus was at least until recently, I'm not sure if it's still going, but looking at geographic atrophy. So wondering if you're thinking there's an opportunity there, if you describe any value to that or if this is really just about Stargardt? And then maybe a second question. You said you're thinking about a potential second Phase III for approval. I just wanted to clarify, are you expecting a second Phase III would be needed? Or is that more of a -- you're thinking about that maybe for commercial purposes to add a different data set or a different layer of data, a different population, that kind of thing? Bobak Azamian: Yes. Thank you, Lachlan. I'll take the first part of that and Sesha will take the second part. So we really look at this in terms of the acquisition as on Stargardt. We see that there's been 400 patients treated, including [ GA ] and that provides a really strong foundation. So while we're acquiring the entire company, our focus is really on Stargardt in terms of the value ascribed here. And Sesha, go on. Seshadri Neervannan: Thank you, Bobby. Yes. As I mentioned, our current Phase III trial, NORTHSTAR is a very robustly designed trial and patients in a large set of patients. In fact, it's potentially the largest progressive prospective trial that's being conducted in Stargardt disease. And it's put very conservatively and very robustly for meeting both the primary and secondary endpoints. And so we are very confident about this trial, providing a very robust clinical package along with the very strong Phase II data as well. So that is our primary approach, and we are very confident that it will be a very compelling evidence for registration and approval. The way we think about the second trial is really proactively thinking about any risk mitigation if we need it. And also any potential upside where we could enhance the data, enhance the exercise to stay with the fast progressors or other ways to enhance it. So it's really more of a risk mitigation and potential upside strategy. And we still need to talk to the FDA about how that study may look like. So stay tuned for how that progresses. Operator: And our next question comes from Mazi Alimohamed of Oppenheimer. Mazahir Alimohamed: So I think one from us is that I think when we're looking -- so it sounds like Alkeus has previously mentioned that the cleanest signal in Stargardt came from the presymptomatic and early-stage patients. But we noticed that NORTHSTAR is enrolling advanced disease. So how do we square the pivotal population with the mechanism? Is the expectation just a slower atrophy to the front at the lesion margin? And I guess the second follow-up to that is if that's the case, what reduction there do you consider clinically meaningful? Seshadri Neervannan: Yes. Thank you, Mazi, for the question. So the NORTHSTAR trial is designed for advanced patients, but also include younger and progressive patients. As I mentioned, it includes patients from age of 8 to 45. And we're really capturing those patients in the disease state. The [Technical Difficulty] lesion, in a group of atrophic lesion, which is very well-known and unprecedent endpoint by the FDA for approval. And that's how it is designed. And these data showed that there's a very robust reduction of that atrophic lesions in the trial. We saw about 29% reduction compared to placebo. So I think the study is designed to hit on the primary endpoints and secondary endpoint of like visual acuity that is presented with the FDA. And really, it's positioned to win on those endpoints. Bobak Azamian: And I'll just add, when we looked at the data package here, we saw really good signals through our multiple Phase II studies in both moderate disease, advanced disease and some early patients. So we got confident across the spectrum of disease that Sesha is describing here in NORTHSTAR. Mazahir Alimohamed: Got it. And then I guess with that, so if tinlarebant is approved, how could that affect trial enrollment going forward? Seshadri Neervannan: We don't think so. We -- the trial -- the NORTHSTAR trial is being conducted globally at many sites. And the trial is already enrolling. We started the trial 2 months ago, Alkeus started trial 2 months ago, and it's enrolling as expected. And we anticipate that by the time other products could be approved and launched, we'll be well underway in terms of our enrollment. And also, as I mentioned, we have the non-U.S. sites that we can also leverage evened on that. Operator: And our next question comes from Francois Brisebois of LifeSci Capital. Unknown Analyst: This is [ Dan ] on for Frank. Congrats on all the progress. I guess, firstly, on the XDEMVY retreatment rates reaching high teens. Could you give us some color on what you're seeing in terms of XDEMVY's durability of treatment response and physician retreatment behavior as you think about -- I believe you have previously mentioned that rate kind of stabilizing around 20% and your confidence there? And secondly, in terms of the DTC efforts, could you give us some color on how that kind of -- in terms of website engagement, what that conversion rate is into sort of treated patients? Neera Clase: Sure. In terms of retreatment, it's maturing just as we've described in the past. It continues to advance into the high teens, and we see it stabilizing at about a 20% steady state. The why really matters here when we think about retreatment, DB is a recurring condition and only ECPs can make that decision to retreat. And so we're seeing exactly what we want, patients who actually have good experience with XDEMVY to begin with, come back when their symptoms recur. And this is still very much a new prescription story as it relates to retreatment. The second part of your story was around -- or your question was around the DTC piece. And our consumer engine is really performing ahead of our own expectations. What we've seen is increasing awareness through branded, unbranded and our celebrity campaign with Cena. The unaided awareness is now up to 30%. And if you think about it, where we started, we were at 2%. Now 1 in every 3 patients can recognize XDEMVY by name. So that's really quite exceptional velocity for a disease that most people really never heard of. And our website engagement is also up by 30% and patients are, as we mentioned, asking for XDEMVY by name. On spend, you could think about it as it's being very efficient and very disciplined, and the returns continue to support the continued investment. Operator: And our next question comes from Matthew Caufield of H.C. Wainwright. Matthew Caufield: Really great to see the range of updates this morning. So 2 questions from us. With the evolving pipeline now with data catalysts across the coming years, is there any shift to the prioritization of programs other than the partnership potential for Lyme disease? And then separately, regarding the Alkeus acquisition, what milestones would define success over the next 12 to 24 months, considering the Phase III NORTHSTAR top line are expected later into second half ' 29, just in terms of judging whether the acquisition is tracking kind of above or below your near-term expectations? Jeffrey S. Farrow: Matt, this is Jeff. Happy to answer those questions. So no pipeline shift. We're -- we have a robust balance sheet that will continue to allow us to focus on the existing pipeline. We're really excited about the ocular rosacea program. You highlighted the Lyme, which our baseline assumption is to partner with a Phase II-ready package. But also the iRenix product is something that we're really excited about getting into the market here in the next couple, 3 years. So we're fully committed to the pipeline, including the Alkeus Phase III study. And then on sort of the data flow on the Alkeus, the ALK-001, in essence, what we'll obviously be tracking is patient enrollment. And so that will be something key. There is a design within the study that would allow for an interim analysis. That is something that we are going to discussing internally and it makes sense to do, but that is a potential option for us to do. And then, of course, there'll be the data -- top line data, which we expect to be sometime in the second half of 2029. Operator: And our next question comes from Anthea Li of Jefferies. Anthea Li: This is Anthea on for Dennis. Just 2 questions from us. On the XDEMVY guidance, the implied script trajectory looks fairly conservative, even accounting for holidays and seasonality. Is there anything we're missing in terms of script acceleration in the second half outside of seasonality? And then secondly, how are you thinking about profitability now that you need to probably ramp up R&D spend for these 2 new assets and then also expand the sales force? I think consensus has Tarsus becoming EBIT positive in '27. Do you still think that's fair? Jeffrey S. Farrow: Sure. Happy to take that question. No, we believe the guidance that we gave is appropriate guidance based on what we've historically seen in terms of seasonality and the expectations for various meetings and holidays. So we stand by that guidance. Of course, we always have an opportunity to update that in subsequent quarters. But right now, we're pleased how we've moved that up. I think it shows robust growth. On the profitability, we haven't commented on profitability yet. That said, if you take a look at the guidance that we have provided, take the top end of the revenue and the bottom end of the OpEx, you could see us going profitable sometime in '27. Even with the incremental spend on iRenix and the Alkeus in the time frame of when those data will turn over, shift our ability to go profitable maybe perhaps by a quarter or 2. Neera Clase: And then the last part of that question was the sales force piece, and I'll take that. In terms of -- as we think about sales force with the new assets, you can think about a different sales force of between 50 to 75 complete team. Operator: This concludes our question-and-answer session and today's conference call. Thank you for participating, and you may now disconnect. Before you buy stock in Tarsus Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Tarsus Pharmaceuticals wasn’t one of them. 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TranscriptFY2026 Q22026-08-12FY2026 Q2 earnings call transcript
Earnings source - 81 paragraphs
FY2026 Q2 earnings call transcript
Hello, welcome to Tarsus Pharmaceuticals' second quarter 2026 financial results conference call, announcement to acquire Alkeus Pharmaceuticals. 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 Sarah Knives, 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 related materials we will be discussing today. Joining me on the call are Bobby Azamián, our Chief Executive Officer and Chairman, Neera Clase, our Interim Chief Commercial Officer, Sesha Neervannan, our Chief Operating Officer, Jeff Farrow, our Chief Financial Officer and Chief Strategy Officer. Joining us for Q&A is Dr. Liz Yue, our Chief Medical Officer. I'd like to draw your attention to slide three, which contains our forward-looking statement. 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, 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, thank you for joining us. Today is an important day for Tarsus. We're reporting another exceptional quarter for XDEMVY 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, executing with excellence, we could fundamentally change patient care while building a leading eye care company. XDEMVY continues to prove that thesis. Nearly three years after launch, more than 700,000 patients have been treated.
XDEMVY has generated almost $1 billion in net product sales reported to date. 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. 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. 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. We believe ALK-001 has the potential to preserve vision longer in patients suffering from Stargardt disease. XDEMVY remains the 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.
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. 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 million in potential peak sales. As Bobby mentioned, XDEMVY is the cornerstone of our company. Across every metric that matters, eye care professional adoption, consumer activation, and commercial execution, the business has never been stronger. These three 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.
The numbers reinforce the acceleration we are seeing. Over the past year, the number of ECPs prescribing XDEMVY at a year 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're 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 chalazia, which further reinforces XDEMVY as the standard of care over tea tree oil and highlights the potential infection risk associated with Demodex and bacterial co-infestation.
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 our highest potential practices. They are helping those practices embed screening more consistently, identify more patients, and expand treatment over time. 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 informed patients into eye care practices. Stronger evidence and field execution helps physicians identify and treat more patients. 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. 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 adolescence, 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 seven 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've never had, an investigational medicine with the potential to meaningfully slow progression of this blinding disease. Jeff, over to you.
Thank you, Sesha. Good morning, everyone. All around, this was another outstanding quarter for Tarsus. We delivered XDEMVY revenue, continued expanding our leadership in eye care, and advanced 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 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-$705 million from our prior guidance of $670 million-$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 the normal seasonality of the eye care market. The summer period typically includes fewer physician office visits due to vacations, holidays, and conferences, and we expect tempered growth in the third quarter. 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-$565 million. We now expect full year R&D expense to be in the range of $190 million-$210 million, an increase from our previous guidance of $115 million-$135 million.
This 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. This upfront consideration is $450 million, consisting of $270 million in cash and $180 million in Tarsus common stock. This includes up to $350 million in potential milestones tied to regulatory approval in the United States and the first commercial sale, as well as low single-digit tier decreasing royalties on future net sales. In addition, we secured $125 million through a private placement financing from a syndicate of leading healthcare investors, including several shareholders of Alkeus. This transaction reflects the disciplined 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 of an 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. Personally for 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 line 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, expanded 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.
Thank you. As a reminder, if you have a question, please press star one one on your telephone and 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 Graig Suvannavejh of Mizuho. Your line is open.
Hey, good morning. This is Ryan Rieth on today for Graig Suvannavejh. Thanks for taking our question. Just wanted to ask a little bit about the new asset and how you see it comparing in efficacy to tinlarebant, the Stargardt medication in phase II trials for Belite Bio, which has a head start. Is there any differentiating factor that you think could help gildeuretinol to capture more market share relative to tinlarebant? Thanks.
Thank you, Ryan. This is Bobby. We're really excited about this asset. As mentioned, we really surveyed the landscape and found a very compelling late-stage opportunity. We understand that we're likely going second here. We're still very compelled by this. In terms of overall profile, we see something that can really change the course of this disease that demonstrated effectiveness in a couple dimensions that are really important to patients. Both the progression of disease as measured by atrophy and the progression of disease measured by visual acuity, low light visual acuity in particular. That's unique in this field. We also see a great safety profile with up to seven years of data over 400 patients treated. 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, thanks for that question, Greg. 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, we also want to make sure that the vitamin A participation in the visual cycle is not perturbed. That's precisely what this medicine does. It's actually shown in the data that we don't see any night vision adaptation or color disturbances, a very good safety and tolerability profile. We think this medicine will differentiate itself on those properties, it's very important for the patient, especially in a blinding disease, to not impact the visual cycle.
Ryan, maybe I'll add. This is Jeff. We did some market research on what Sesha just highlighted there. Showing structural benefit, functional benefit with LLVA, a really nice safety profile. We surveyed 100 retinal docs. Based on that, we really think that this is a billion-dollar-plus opportunity based on that micro by that differentiation there.
Great. All right, thanks guys.
Thank you. Our next question comes from Eddie Hickman of Guggenheim Securities. Your line is open.
Hey, guys. Good morning, thanks for the question, congrats on all the progress and the deals. Now that you're building towards two retinal launches sort of on different timelines, 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. Yeah, Eddie, I'll start, I'll pass to our Commercial Officer, Neera. 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 six years ago when we were at that same stage with XDEMVY, we took a very diligent approach to understanding the eye care provider and really educating. I know we'll do that here as well. We have 2 drugs in phase III, one IRX-101's a little bit ahead, ALK-001, I think it positions us well, I'll pass to Neera to talk about some of the synergies she sees.
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. It plays exactly to what we've been doing with XDEMVY. 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. What's different here in terms of the call points 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. It's a different playbook from the DB, but very similar footprint. As you know, we've proven that we can execute, and we're really excited about this opportunity.
The other thing I'd point out.
Just on.
There's a lot of overlap in the calling here, so about 500 doctors will be served with IRX-101 that are doing IVTs. A subset of those, actually 2,000, are prescribing, we think, or likely to prescribe over 80% of the Stargardt disease therapies here. That presents some real synergy in terms of the sales force itself that we'll be building here.
Got it. In terms of access, is that the same timeline as XDEMVY in terms of sort of getting payer reimbursement set up? 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.
Appreciate it.
The other thing I'll have Elizabeth Yeu, our CMO, talk about, now we're in front of the eye company, and this is often where patients with Stargardt's present. Liz, you might speak to your experience and how you see kind of the initial assessment in the eye care provider landscape there.
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. While most of the diseases that we see as eye care providers see, they worsen with aging. What's so unique and so humbling about Stargardt disease is that almost half the patient population are actually kids and adolescents. Of those who are the fastest progressers, half of them actually go blind within seven years.
The opportunity for us to be able to manage them together alongside a lot of the patients who are getting seen, especially those who are younger, they may complain or fail a vision test at school. It's going to be primed by those primary eye care physicians who are seeing them because of those complaints, failed vision tests, or because they're coming in for glasses, will be then diagnosed by the retina specialist. It will be a shared opportunity. 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 evidence.
Great. Thank you so much for that color.
Thank you. Our next question comes from Jason Gerberry of Bank of America. Your line is open.
Hey, guys. Thanks for taking my questions. I'm just trying to think about, A, the market opportunity here. I think you said something like 30 some thousand patients. Belite Bio's talked about a pricing in the $350K-$500K territory. Trying to get a sense of what proportion of these patients are actually under the care of a retinal specialist and is an addressable sort of market. Secondly, a question around how to think about the use of natural history. On BCVA changes over, say, a two-year period versus lesion growth, I think, the competitor had flagged you typically would lose one letter every two years or so. Wondering how you think about the need for longer-term follow-up and sort of the durable BCVA benefit. Thanks.
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 $350K price point. It's really about value creation, right? Understanding the differentiated profile here. As we think about this particular asset, there is a safety and tolerability value proposition that really resonates here and differentiates from the competition. We're excited to launch in this. 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 color.
Yeah. Thank you, Neera. With respect to your question on long-term follow-up on the vision benefit, what we saw in the trials is that the worsening of low light visual acuity, which is actually even more of a sensitive measure than a BCVA, was statistically significant. We saw benefit within two years in those trials. That is a great measure to follow up because low light visual acuity is a precursor of BCVA loss. BCVA tends to worsen slower than LLVA. That's a great measure for the physicians to monitor and look at the progress of the vision loss. The tools are there, and they are very mature.
Hello?
Our next question comes from Lachlan Hanbury-Brown of William Blair. One moment.
Hey, just wondering if the team is there. I think they cut out on that last question.
We're here. We're here.
All right, great. Thanks for the questions. Congrats on the deal, I guess. Maybe a couple quick ones. Just first, you've been talking a lot about the Stargardt program with gildeuretinol, but I know that Alkeus, at least until recently, I'm not sure if it's still going, but looking at geographic atrophy. Wondering if you're thinking there's an opportunity there, if you've ascribed any value to that, or if this is really just about Stargardts? Maybe a second question. You said you're thinking about a potential second phase III for approval. I just wanted to clarify, are you expecting a second phase III would be needed, or is that more of a, you're thinking about that maybe for commercial purposes to add a different data set or a different layer of data, a different population, that kind of thing?
Thank you, Lachlan. I'll take the first part of that. Sesha will take the second part. We really looked at this in terms of the acquisition as far as Stargardt. We see that there's been a 400 patients treated, including the GA, that provides a really strong foundation. While we're acquiring the entire company, our focus is really on Stargardts in terms of the value ascribed here. Sesha, I'll pass it to you.
Thank you, Bobby. Yeah. As I mentioned, our current phase III trial, NORTHSTAR, is a very robustly designed trial in a large set of patients. In fact, it's potentially the largest progressive prospective trial that are being conducted in Stargardt disease. It's powered very conservatively and very robustly for meeting both the primary and secondary endpoints. We are very confident about this trial providing a very robust clinical package along with the very strong phase II data as well. That is our primary approach. We are very confident that it will be a very compelling evidence for registration and approval. The way we think about the second trial is really proactively thinking about any of this medication if we need it. Also any potential upside where we could enhance the data, enhance the exercise with the progressors or other ways to enhance it.
It's really more of a risk mitigation and potential upside strategy. We still need to talk to the FDA about how that study may look like. Stay tuned for how that progresses.
Thank you.
Thanks.
Our next question comes from Mazahir Alimohamed of Oppenheimer. Your line is open.
Thank you. Thanks, Bobby, and thanks for taking the question. I think one for us is that when we were looking, it sounds like Alkeus has previously mentioned that the cleanest signal in Stargardt disease came from the pre-symptomatic and early-stage patients, but we noticed that NORTHSTAR is enrolling advanced disease. How do we square the pivotal population with the mechanism? Is the expectation just at a slower atrophy front at the lesion margin? If that's the case, what reduction there do you consider clinically meaningful?
Thank you, Nazir, for the question. The NORTHSTAR trial is designed for advanced patients but also includes younger and progressive patients. As I mentioned, it includes patients from age of 8 to 45, and we're really capturing those patients in their disease state. The atrophic lesion, or growth of atrophic lesion, which is very well known and precedented endpoint by the FDA for approval. That's how it is designed. The phase data showed that there's a very robust reduction of that atrophic lesions in the trials. We saw about 29% reduction compared to placebo. I think the study is designed to hit on the primary endpoints and secondary endpoint of visual acuity that is precedented with the FDA. Really it's positioned to win on those endpoints.
I'll just add when we looked at the data package here, we saw really good signals throughout multiple phase II studies, in both moderate disease, advanced disease, and in some early patients. We got confident across the spectrum of disease that Sais is describing here in NORTHSTAR.
Got it. Thank you. If tinlarebant is approved, how could that affect trial enrollment going forward?
We don't think so. The NORTHSTAR trial is being conducted globally at many sites. The trial is already enrolling. We started the trial two months ago. Alkeus started the trial two months ago, and it's enrolling as expected. We anticipate that by the time other products could be approved and launched, we'll be well underway in terms of our enrollment. Also, as I mentioned, we have many non-placebo sites that we can also leverage.
Got it. Okay. Thank you for taking our questions.
Thank you. Our next question comes from François Brisebois of LifeSci Capital. Your line is open.
Hi. Thanks for taking our questions. This is Dan on for Frank. Congrats on all the progress. I guess firstly on the XDEMVY retreatment rates, reaching high teens, could you give us some color on what you're seeing, in terms of XDEMVY's durability of treatment response and physician retreatment behavior? As you think about, I believe you have previously mentioned that rate kind of stabilizing around 20%, and your confidence there. Secondly, in terms of the DTC efforts, could you give us some color on how that kind of, in terms of website engagement, what that conversion rate is into sort of treated patients? Thank you.
Sure. In terms of retreatment, it's maturing just as we've described in the past. It continues to advance into the high teens, and we see it stabilizing at about a 20% steady state. The why really matters here when we think about retreatment. DB is a recurring condition, and only ETPs can make that decision to retreat. We're seeing exactly what we want. Patients who actually have good experience with XDEMVY to begin with come back when their symptoms recur. This is still very much a new prescription story as it relates to retreatment. The second part of your story was around, or your question was around the DTC piece. Our consumer engine is really performing ahead of our own expectations. What we've seen is increasing awareness through branded, unbranded, and our celebrity campaign with Cena. The unaided awareness is now up to 30%.
If you think about it, where we started, we were at 2%. Now one in every three patients can recognize XDEMVY by name. That's really quite exceptional velocity for a disease that most people really never heard of. Our website engagement is also up by up to 30%. Patients are, as we mentioned, asking for XDEMVY by name. On spend, you could think about it as it being very efficient and very disciplined, and the returns continue to support the continued investment.
Thank you.
Thank you. Our next question comes from Matthew Caulfield of H.C. Wainwright. Your line is open.
Good morning, guys. Really great to see the range of updates this morning. Two questions from us. With the evolving pipeline now with data catalysts across the coming years, is there any shift to the prioritization of programs other than the partnership potential for Lyme disease? Separately, regarding the Alkeus acquisition, what milestones would define success over the next 12-24 months considering the phase III NORTHSTAR top line are expected later into second half 2029? Just in terms of judging whether the acquisition is tracking kind of above or below your near-term expectations. Thanks a lot.
Good morning, Matt. This is Jeff. Happy to answer those questions. No pipeline shift. We have a robust balance sheet that will continue to allow us to focus on the existing pipeline. We are really excited about the ocular rosacea program. You highlighted the Lyme, which our baseline assumption is to partner with a phase-ready package. Also the iRenix product is something that we are really excited about getting into the market here in the next couple, three years. We are fully committed to the pipeline, including the Alkeus phase III study. On sort of the data flow on the Alkeus, the ALK-001. In that sense, one of the things we will obviously be tracking is with patient enrollment, and so that'll be something key. There is a design within the study that would allow for an interim analysis.
That is something that we are going to be discussing internally and see if it makes sense to do, but that is a potential option for us to do. Of course, there'll be the data, top line data, which we expect to be sometime in the second half of 2025.
Excellent. Thank you, guys. Really exciting to see all the updates.
Thank you.
Thank you. Our next question comes from Anthea Lee of Jefferies. Your line is open.
Hi, this is Anthea on for Dennis. Thank you for taking our questions. Just two questions from us. On the XDEMVY guidance, the implied script trajectory looks fairly conservative, even accounting for holidays and seasonality. Is there anything we're missing in terms of script acceleration in the second half outside of seasonality? Secondly, how are you thinking about profitability now that you need to probably ramp up R&D spend for these two new assets and also expand the sales force? I think consensus has Tarsus becoming EBITDA positive in 2027. Do you still think that's fair? Thank you.
Sure. Happy to take that question. We believe the guidance that we gave is appropriate guidance based on what we've historically seen in terms of seasonality, and the expectations for various meetings and holidays. We stand by that guidance. Of course, we always have an opportunity to update that in subsequent quarters, but right now we're pleased how we've moved that up. I think it shows robust growth. On the profitability, we haven't commented on profitability yet. That said, if you take a look at the guidance that we have provided, take the top end of the revenue and the bottom end of the OpEx, you could see us going profitable sometime in 2027. Even with the incremental spend on iRenix and the Alkeus in the timeframe of when those data will turn over, shift our ability to go profitable maybe perhaps by a quarter or two.
The last part of that question was the sales force piece, and I'll take that. In terms of as we think about sales force with the new assets, you can think about a different sales force of between 50 to 75 complete team.
Okay, great. Thank you so much.
Thank you. This concludes our question and answer session and today's conference call. Thank you for participating, and you may now disconnect.
Investor releaseQuarter not tagged2026-08-07Tarsus Pharmaceuticals Q2 Earnings Call Highlights
MarketBeat
Tarsus Pharmaceuticals Q2 Earnings Call Highlights
Interested in Tarsus Pharmaceuticals, Inc.? Here are five stocks we like better. XDEMVY sales rose 69% year over year to $173.9 million in the second quarter, prompting Tarsus to raise its 2026 sales outlook to $685 million–$705 million. More than 700,000 patients have used the Demodex blepharitis treatment since launch. Tarsus agreed to acquire Alkeus Pharmaceuticals for $450 million upfront, adding late-stage Stargardt disease therapy ALK-001 to its pipeline. The Phase III NORTHSTAR trial is underway, with top-line results expected in the second half of 2029. The transaction expands Tarsus’ strategy beyond XDEMVY into retina care but will increase near-term spending. The company raised 2026 R&D guidance to $190 million–$210 million and said profitability could potentially arrive in 2027, subject to acquisition-related costs. 3 Biotech Catalysts Present Major Opportunity Tarsus Pharmaceuticals (NASDAQ:TARS) reported second-quarter growth in sales of its Demodex blepharitis treatment XDEMVY and announced a pending acquisition of Alkeus Pharmaceuticals, adding late-stage investigational Stargardt disease therapy gildeuretinol, also known as ALK-001, to its pipeline. Chief Executive Officer and Chairman Bobby Azamian said the company views the transaction as an expansion of its strategy to build a larger eye-care business beyond XDEMVY. The proposed acquisition also broadens Tarsus’ presence in retina, following its recent acquisition involving IRX-101. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth “XDEMVY continues to prove that thesis,” Azamian said, referring to the company’s approach of addressing overlooked eye-care diseases with new treatments. He said more than 700,000 patients have been treated with XDEMVY since launch and that the product has generated almost $1 billion in reported net product sales to date. XDEMVY generated $173.9 million in second-quarter net product sales, up more than 69% from a year earlier and approximately 20% from the prior quarter. Tarsus said gross margin was approximately 93%, unchanged from the prior period, and it ended the quarter with $449.7 million in cash, cash equivalents and marketable securities. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High The company raised its 2026 XDEMVY net product sales guidance to between $685 million and $705 million, from a prior range of $670 million to $700 mill…Read full documentShow less
Interested in Tarsus Pharmaceuticals, Inc.? Here are five stocks we like better. XDEMVY sales rose 69% year over year to $173.9 million in the second quarter, prompting Tarsus to raise its 2026 sales outlook to $685 million–$705 million. More than 700,000 patients have used the Demodex blepharitis treatment since launch. Tarsus agreed to acquire Alkeus Pharmaceuticals for $450 million upfront, adding late-stage Stargardt disease therapy ALK-001 to its pipeline. The Phase III NORTHSTAR trial is underway, with top-line results expected in the second half of 2029. The transaction expands Tarsus’ strategy beyond XDEMVY into retina care but will increase near-term spending. The company raised 2026 R&D guidance to $190 million–$210 million and said profitability could potentially arrive in 2027, subject to acquisition-related costs. 3 Biotech Catalysts Present Major Opportunity Tarsus Pharmaceuticals (NASDAQ:TARS) reported second-quarter growth in sales of its Demodex blepharitis treatment XDEMVY and announced a pending acquisition of Alkeus Pharmaceuticals, adding late-stage investigational Stargardt disease therapy gildeuretinol, also known as ALK-001, to its pipeline. Chief Executive Officer and Chairman Bobby Azamian said the company views the transaction as an expansion of its strategy to build a larger eye-care business beyond XDEMVY. The proposed acquisition also broadens Tarsus’ presence in retina, following its recent acquisition involving IRX-101. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth “XDEMVY continues to prove that thesis,” Azamian said, referring to the company’s approach of addressing overlooked eye-care diseases with new treatments. He said more than 700,000 patients have been treated with XDEMVY since launch and that the product has generated almost $1 billion in reported net product sales to date. XDEMVY generated $173.9 million in second-quarter net product sales, up more than 69% from a year earlier and approximately 20% from the prior quarter. Tarsus said gross margin was approximately 93%, unchanged from the prior period, and it ended the quarter with $449.7 million in cash, cash equivalents and marketable securities. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High The company raised its 2026 XDEMVY net product sales guidance to between $685 million and $705 million, from a prior range of $670 million to $700 million. Tarsus said it expects third-quarter growth to be tempered by typical summer seasonality in eye care, including physician vacations, holidays and conferences, before more robust growth in the fourth quarter. Interim Chief Commercial Officer Neera Clase said prescribing activity has continued to broaden. The number of eye-care professionals prescribing XDEMVY at a daily cadence doubled over the past year, according to Clase, while retreatment rates have moved into the high teens. She said Tarsus expects retreatment rates to stabilize at approximately 20% over time. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling Clase also highlighted consumer-awareness efforts, including campaigns featuring John Cena and an unbranded direct-to-consumer campaign featuring “Barry the Cat.” Tarsus said unaided awareness of Demodex blepharitis has reached approximately 30%, while high-value actions on the XDEMVY website increased 19%. Those actions include use of the company’s Find a Doctor tool and its AI-powered patient concierge. The company estimates that approximately 25 million Americans are living with Demodex blepharitis. Clase said more than 80% of physicians surveyed by the company expect to increase XDEMVY prescribing over the next year and beyond. The pending Alkeus acquisition centers on ALK-001, an investigational modified vitamin A analog designed to reduce formation of toxic vitamin A dimers, or bisretinoids, while preserving the normal visual cycle. Tarsus said those toxic byproducts contribute to retinal cell damage in Stargardt disease, an inherited retinal disorder that can cause progressive central-vision loss and blindness. Chief Operating Officer Sesha Neervannan said Stargardt disease affects children and young adults and currently has no FDA-approved therapies. Tarsus cited more than 36,000 diagnosed U.S. patients and an estimated total U.S. population of 86,000 patients. The company said half of patients diagnosed before age 20 are expected to become legally blind within seven years. ALK-001 has been evaluated in more than 400 patients, with treatment exposure extending up to seven years, according to Tarsus. Neervannan said the program has shown encouraging evidence of preserved visual function and no evidence of treatment-related negative effects on night vision, dark adaptation or color vision. The ongoing Phase III NORTHSTAR study is expected to enroll about 230 patients ages 8 to 45. Its primary endpoint is the rate of retinal lesion growth over 24 months, while a secondary endpoint assesses low-luminance visual acuity. Tarsus expects top-line results in the second half of 2029 and said it is considering a second Phase III trial, to be discussed with the FDA, that could focus on younger and faster-progressing patients. During the question-and-answer session, Neervannan said Phase II trials showed an approximately 29% reduction in atrophic lesions compared with placebo. He said NORTHSTAR began enrolling about two months ago and is enrolling as expected. Tarsus said its market research with 100 retinal specialists supported its view that ALK-001 could represent a billion-dollar-plus opportunity. The company said it expects approximately 2,000 physicians to account for more than 80% of Stargardt disease prescribing and sees overlap with physicians who could prescribe IRX-101. Clase said a future retina commercial team could include roughly 50 to 75 people. Tarsus agreed to pay $450 million upfront for Alkeus, consisting of $270 million in cash and $180 million in Tarsus common stock. The agreement also includes up to $350 million in potential milestones tied to U.S. regulatory approval and the first commercial sale, plus low-single-digit, tiered decreasing royalties on future net sales. The company also secured $125 million through a private placement financing from healthcare investors, including several Alkeus shareholders. The transaction is expected to close later in 2026, subject to the expiration of the applicable Hart-Scott-Rodino waiting period and other customary conditions. Tarsus maintained guidance for gross margin of approximately 93% and selling, general and administrative expenses of $545 million to $565 million for 2026. It increased research and development expense guidance to $190 million to $210 million from $115 million to $135 million, reflecting $75 million of upfront consideration associated with the iRenix Medical acquisition. The company said this guidance does not include the pending Alkeus acquisition. Chief Financial Officer and Chief Strategy Officer Jeff Farrow said Tarsus has not formally provided profitability guidance. However, he said that using the high end of revenue guidance and the low end of operating expense guidance could indicate profitability sometime in 2027, though spending related to iRenix and Alkeus could shift that timing by “perhaps by a quarter or two.” Tarsus Pharmaceuticals, Inc is a clinical‐stage biopharmaceutical company focused on developing novel therapies for diseases of the eye and ocular surface. The company's research platform centers on neuro‐effector modulation to address underlying disease mechanisms rather than solely treating symptoms. Tarsus's lead candidate, OC-01 (varenicline solution), is an intranasal formulation in Phase 3 development for the treatment of dry eye disease, a condition affecting millions worldwide and associated with significant patient discomfort and reduced quality of life. In addition to its dry eye program, Tarsus is advancing preclinical and early‐stage programs targeting other ophthalmic indications, including allergic conjunctivitis and retinal disorders. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Tarsus Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.
Investor releaseQuarter not tagged2026-08-06Tarsus to Report Second Quarter 2026 Financial Results on Thursday, August 6, 2026
GlobeNewswire
Tarsus to Report Second Quarter 2026 Financial Results on Thursday, August 6, 2026
IRVINE, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced that it will host a live webcast at 5:00 a.m. PT / 8:00 a.m. ET on Thursday, August 6, 2026 to report its second quarter 2026 financial results and provide a corporate update. Participants may access the webcast here. A recorded version of the call will be available on the website shortly after the completion of the webcast and will be archived there for approximately 90 days. About Tarsus Pharmaceuticals, Inc.Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. XDEMVY® (lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-04 for the potential treatment of ocular rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease, both of which are in Phase 2, and IRX-101 for potential use as an ocular antiseptic. Media Contact:Adrienne KempVice President, Corporate Communications(949) [email protected] Investor Contact:David NakasoneHead of Investor Relations(949) [email protected]
Investor releaseQuarter not tagged2026-08-06Tarsus Reports Second Quarter 2026 Financial Results, Advances Next Phase of Growth
GlobeNewswire
Tarsus Reports Second Quarter 2026 Financial Results, Advances Next Phase of Growth
Generated second quarter 2026 XDEMVY® net product sales of $173.9 million, an increase of more than 69% year-over-year Increased full-year 2026 XDEMVY net product sales guidance to $685-705 million Pending acquisition of Alkeus Pharmaceuticals to expand Tarsus’ retina pipeline with a Phase 3 clinical program for Stargardt disease, an inherited retinal disease affecting more than 36,000 patients in the United States that can lead to blindness Priced $125 million private placement financing which included participation from top-tier funds and several existing Alkeus Pharmaceuticals investors Management to host conference call today, August 6, 2026, at 5:00 a.m. PT / 8:00 a.m. ET IRVINE, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced financial results for the second quarter ended June 30, 2026. “XDEMVY delivered another record quarter, reflecting strong underlying demand and commercial execution,” said Bobby Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus. “This performance gives us the commercial foundation and financial strength to remain intensely focused on growing XDEMVY while strategically investing in our next wave of growth. Together with today’s announcement of our agreement to acquire Alkeus Pharmaceuticals, we are building what we believe is one of the most compelling late-stage pipelines, with multiple opportunities to improve patient care and create long-term value.” Recent Business and Clinical Highlights XDEMVY generated second quarter 2026 net product sales of $173.9 million, a year-over-year increase of more than 69%. Direct-to-consumer (DTC) initiatives continued to contribute to prescription growth and awareness. Appointed Neera Clase, Interim Chief Commercial Officer as the Company enters its next phase of growth. Tarsus continues to advance one of the most compelling pipelines in eye care, with multiple near-term catalysts across a diverse portfolio of clinical-stage programs. Completed the acquisition of iRenix Medical, which established Tarsus’ first strategic position in retina and added a late-stage opportunity that builds on the company’s innovation in eye care and commercial capabilities. Entered into an agreement to acquire Alkeus Pharmaceuticals and ALK-001, an investigational once-daily oral therapy with a differentiated approach designed to reduce toxic V…Read full documentShow less
Generated second quarter 2026 XDEMVY® net product sales of $173.9 million, an increase of more than 69% year-over-year Increased full-year 2026 XDEMVY net product sales guidance to $685-705 million Pending acquisition of Alkeus Pharmaceuticals to expand Tarsus’ retina pipeline with a Phase 3 clinical program for Stargardt disease, an inherited retinal disease affecting more than 36,000 patients in the United States that can lead to blindness Priced $125 million private placement financing which included participation from top-tier funds and several existing Alkeus Pharmaceuticals investors Management to host conference call today, August 6, 2026, at 5:00 a.m. PT / 8:00 a.m. ET IRVINE, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced financial results for the second quarter ended June 30, 2026. “XDEMVY delivered another record quarter, reflecting strong underlying demand and commercial execution,” said Bobby Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus. “This performance gives us the commercial foundation and financial strength to remain intensely focused on growing XDEMVY while strategically investing in our next wave of growth. Together with today’s announcement of our agreement to acquire Alkeus Pharmaceuticals, we are building what we believe is one of the most compelling late-stage pipelines, with multiple opportunities to improve patient care and create long-term value.” Recent Business and Clinical Highlights XDEMVY generated second quarter 2026 net product sales of $173.9 million, a year-over-year increase of more than 69%. Direct-to-consumer (DTC) initiatives continued to contribute to prescription growth and awareness. Appointed Neera Clase, Interim Chief Commercial Officer as the Company enters its next phase of growth. Tarsus continues to advance one of the most compelling pipelines in eye care, with multiple near-term catalysts across a diverse portfolio of clinical-stage programs. Completed the acquisition of iRenix Medical, which established Tarsus’ first strategic position in retina and added a late-stage opportunity that builds on the company’s innovation in eye care and commercial capabilities. Entered into an agreement to acquire Alkeus Pharmaceuticals and ALK-001, an investigational once-daily oral therapy with a differentiated approach designed to reduce toxic Vitamin A dimer formation in the retina - targeting the underlying biology of Stargardt disease - and a Phase 3 clinical program. Second Quarter 2026 Financial Results Product sales, net: were $173.9 million compared to $102.7 million for the same period in 2025, driven by higher volume and improvements in the gross-to-net discount. Cost of sales: were $12.1 million compared to $6.2 million for the same period in 2025, due to manufacturing costs related to XDEMVY, the royalty Tarsus pays on net product sales, and amortization expense for the milestone payments made to the Company’s licensor, which is being amortized over its remaining useful life. Gross margins remained consistent at 93% compared to 94% for the same period in 2025. Research and development (R&D) expenses: were $31.0 million compared to $15.6 million for the same period in 2025. The increase was primarily due to $8.0 million of TP-05 program expenses related to the Company’s Calliope trial, which was initiated in March 2026 and has since completed enrollment, $3.2 million of payroll and personnel-related costs (including non-cash stock-based compensation), $3.1 million of TP-03 program expenses, and $0.5 million of other early-stage development expenses. R&D non-cash stock-based compensation expense incurred was $3.0 million, compared with $1.9 million in the same period in 2025. Selling, general and administrative (SG&A) expenses: were $150.7 million compared to $103.0 million for the same period in 2025. The increase was due primarily to $21.2 million of commercial and marketing costs, including DTC advertising costs as the Company continued to expand promotional efforts for XDEMVY’s commercial launch, $19.5 million of costs associated with patient support functions, information technology, legal, and professional services, and $6.7 million of payroll and personnel-related costs for commercial and corporate employee additions to support the Company’s continued growth and expansion of its commercial leadership team. SG&A non-cash stock-based compensation expense was $10.1 million, compared with $6.1 million in the same period in 2025. Net loss: was $18.6 million, compared to $20.3 million for the same period in 2025. Basic and diluted net loss per share was $(0.43), compared with $(0.48) for the same period in 2025. Cash position: As of June 30, 2026, cash, cash equivalents and marketable securities were $449.7 million. Year-to-Date 2026 Financial Results Product sales: were $319.3 million compared to $181.0 million for the same period in 2025, driven by higher volume and improvements in the gross-to-net discount. License fees and collaboration revenue: were $16.7 million from the Company’s China out-license partner related to a $15.0 million regulatory milestone achieved under the China out-license in the first quarter of 2026 and $1.7 million of required China withholding tax associated with this milestone. The milestone payment was recorded on a gross basis, meaning the $1.7 million of withholding tax was recorded as an increase to license fees and collaboration revenue, with an equal and offsetting amount recorded as foreign tax expense within provision for income taxes. Cost of sales: were $21.5 million compared to $11.4 million for the same period in 2025, due to manufacturing costs incurred after the approval of XDEMVY, the royalty the Company pays on net product sales, and amortization expense for the milestone payments made to the Company’s licensor, which is being amortized over its remaining useful life. Gross margins remained consistent at 93% compared to 94% for the same period in 2025. Research and development (R&D) expenses: were $53.4 million compared to $30.0 million for the same period in 2025. The increase was primarily due to $9.4 million of TP-05 program expenses for the Company’s Calliope trial, which was initiated in March 2026 and has since completed enrollment, $6.9 million of payroll and personnel-related expenses (including non-cash stock-based compensation), $4.0 million of TP-03 program expenses, $0.5 million of other indirect expenses, and a $2.0 million upfront payment made upon execution of a February 2026 in-license agreement. R&D non-cash stock compensation expense was $6.0 million, compared with $3.4 million in the same period in 2025. Selling, general and administrative (SG&A) expenses: were $287.1 million compared to $188.0 million for the same period in 2025. The increase was primarily due to $47.0 million of commercial and marketing costs, including DTC advertising costs, as the Company continued to expand its promotional activities for XDEMVY, $40.7 million of costs associated with patient support functions, information technology, legal and professional services, and $11.1 million of increased payroll and personnel-related expenses (including non-cash stock-based compensation) for commercial and corporate employee additions to support the Company’s continued growth and expansion of its commercial leadership team. SG&A non-cash stock compensation expense was $18.8 million, compared with $11.4 million in the same period in 2025. Net loss: was $25.5 million, compared to $45.5 million for the same period in 2025. Year-to-date basic and diluted net loss per share was $(0.59), compared with $(1.11) for the same period in 2025. Conference Call and WebcastTarsus will host a conference call and webcast to discuss its second quarter 2026 financial results and business highlights today, August 6, 2026, at 5:00 a.m. PT / 8:00 a.m. ET. A live webcast will be available on the events section of the Tarsus website. A recorded version of the call will be available on the website shortly after the completion of the call and will be archived there for at least 90 days. About XDEMVY®XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop designed to treat Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. XDEMVY was evaluated in two pivotal trials involving over 800 patients with twice-daily dosing for six weeks. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found the XDEMVY eye drop to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis. XDEMVY Indication and Important Safety Information INDICATIONS AND USAGEXDEMVY is indicated for the treatment of Demodex blepharitis. Most common side effects: The most common side effect in clinical trials was stinging and burning in 10% of patients. Other side effects in less than 2% of patients were chalazion/hordeolum and punctate keratitis. For additional information, please see full prescribing information available at https://xdemvy.com/. About TP-03TP-03 (lotilaner ophthalmic solution) 0.25% is a novel therapeutic designed to treat Demodex blepharitis by targeting and eradicating the root cause of disease – Demodex mite infestation. It was approved by the FDA in 2023 under the brand name XDEMVY® for the treatment of Demodex blepharitis. Lotilaner is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific gamma-aminobutyric acid-gated chloride (GABA-Cl) channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eyelash follicles where the mites reside. About TP-04TP-04 is an investigational sterile aqueous gel formulation of lotilaner. Tarsus is studying TP-04 for the potential treatment of ocular rosacea (OR). About TP-05TP-05 is an investigational oral systemic formulation of lotilaner. TP-05 is believed to be the only non-vaccine, drug-based, preventative therapeutic in development designed to kill ticks to potentially prevent Lyme disease transmission. About IRX-101IRX-101 is an investigational ocular antiseptic based on a stable aqueous chlorine dioxide solution that is being developed for the potential to reduce post-procedural pain and corneal toxicity in patients receiving intravitreal therapy. About Gildeuretinol Acetate (ALK-001)Gildeuretinol acetate (ALK-001) is an investigational small molecule with once-daily oral formulation targeting toxic Vitamin A dimerization in the retina with a promising tolerability and efficacy profile across 400+ individuals studied. About Tarsus Pharmaceuticals, Inc.Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. XDEMVY® (lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-04 for the potential treatment of ocular rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease, both of which are in Phase 2, and IRX-101 for potential use as an ocular antiseptic. Forward-Looking StatementsStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the potential commercial success and growth of XDEMVY in Demodex blepharitis, including updated 2026 annual net sales guidance; our ability to successfully continue our direct-to-consumer campaigns; our ability to continue to educate the market about Demodex blepharitis; anticipated regulatory and development milestones; the timing for topline data for, and results of our clinical studies including the Phase 2 KORE study for the potential treatment of ocular rosacea, the Phase 2 Calliope study for the potential prevention of Lyme disease including its potential to support a Phase 3-ready package, and the Phase 3 COMFORT study for IRX-101 and its potential benefits as an antiseptic, reduction in post-procedural pain and corneal toxicity in patients receiving intravitreal injections; our ability to continue investing in our business and actively evaluate external opportunities, the benefits of the new interim commercial leader, the pending acquisition of Alkeus Pharmaceuticals and its potential benefits, and the quotations of Tarsus’ management. The words, without limitation, “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “on track,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus is heavily dependent on the continued successful commercialization of its lead product, XDEMVY for the treatment of Demodex blepharitis and the successful development, regulatory approval and commercialization of its current and future product candidates; Tarsus’ ability to obtain and maintain regulatory approval for and successfully commercialize its products, including XDEMVY for the treatment of Demodex blepharitis, and its product candidates to meet existing and future regulatory standards; Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it could continue to incur significant expenses and potential losses in the future; Tarsus’ capital requirements are difficult to predict and may change; Tarsus may need to obtain additional funding to achieve its goals and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force Tarsus to delay, reduce, or eliminate its product development programs, commercialization efforts or other operations; Tarsus may not ultimately be successful in educating healthcare professionals and the market about the need for treatments specifically for Demodex blepharitis and other diseases targeted by XDEMVY or our product candidates; the development and commercialization of Tarsus products and product candidates is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus expects to expand its development, regulatory, operational, distribution, sales, and marketing capabilities and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for XDEMVY and Tarsus’ product candidates, particularly TP-04 for the potential treatment of ocular rosacea, as well as TP-05 for the potential prevention of Lyme disease, have not been established with precision and may be smaller than estimated possibly materially; the results of Tarsus’ earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus’ planned clinical trials could result in increased costs, delay or limit its ability to generate revenue from net product sales and adversely affect its commercial prospects; if Tarsus is unable to obtain and maintain sufficient intellectual property protection for XDEMVY or its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus’ competitors could develop and commercialize products similar or identical to Tarsus’ products; unfavorable global and geopolitical economic conditions, including tariffs; and if Tarsus is unable to access capital (including but not limited to cash, cash equivalents, and credit facilities) and/or loses capital, as a result of potential failure of any financial institutions that Tarsus does business with directly or indirectly. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statements and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus’ Form 10-K for the year ended December 31, 2025 filed on February 23, 2026 and the most recent Form 10-Q quarterly filing filed with the SEC on August 6, 2026, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this earnings release are based on the current expectations of Tarsus’ management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
Investor releaseQuarter not tagged2026-08-06Tarsus Pharmaceuticals Inc (TARS) (Q2 2026) Earnings Call Highlights: Record XDEMVY Sales and ...
GuruFocus.com
Tarsus Pharmaceuticals Inc (TARS) (Q2 2026) Earnings Call Highlights: Record XDEMVY Sales and ...
This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Tarsus Pharmaceuticals Inc (NASDAQ:TARS) reported record second-quarter 2026 net product sales of $173.9 million for XDEMVY, representing over 69% year-over-year growth and approximately 20% quarter-over-quarter growth. The company raised its full-year 2026 product sales guidance to $685 million to $705 million, reflecting strong underlying business momentum and confidence in continued growth. Tarsus Pharmaceuticals Inc (NASDAQ:TARS) announced the acquisition of Alkeus Pharmaceuticals and its lead asset ALK001, a late-stage investigational therapy for Stargardt disease, which has no FDA-approved treatments and represents a significant market opportunity with an estimated 86,000 patients in the US. ALK001 has demonstrated a favorable long-term tolerability profile in over 400 patients with up to seven years of treatment exposure, and has shown potential to preserve visual function without negatively impacting night vision, dark adaptation, or color vision. The company's commercial execution for XDEMVY is strengthening, with the number of eye care professionals prescribing at a near-daily cadence doubling over the past year, retreatment rates advancing into the high teens, and unaided patient awareness of Demodex blepharitis climbing to approximately 30%. Tarsus Pharmaceuticals Inc (NASDAQ:TARS) is building a robust retina portfolio with two Phase III assets (IRX-101 and ALK001), creating potential commercial synergies with a concentrated physician base of about 3,500 retina specialists. The acquisition of Alkeus Pharmaceuticals carries a substantial upfront cost of $450 million (comprising $270 million in cash and $180 million in stock), plus up to $350 million in potential regulatory and commercial milestones, increasing financial risk. Top-line results for the pivotal Phase III NorthStar trial of ALK001 are not expected until the second half of 2029, meaning a long wait before potential approval and revenue generation from this significant investment. Tarsus Pharmaceuticals Inc (NASDAQ:TARS) faces intense competition in the Stargardt disease space, notably from a competitor with a head start in Phase III development, which could impact future market share. The company's increased full-ye…Read full documentShow less
This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Tarsus Pharmaceuticals Inc (NASDAQ:TARS) reported record second-quarter 2026 net product sales of $173.9 million for XDEMVY, representing over 69% year-over-year growth and approximately 20% quarter-over-quarter growth. The company raised its full-year 2026 product sales guidance to $685 million to $705 million, reflecting strong underlying business momentum and confidence in continued growth. Tarsus Pharmaceuticals Inc (NASDAQ:TARS) announced the acquisition of Alkeus Pharmaceuticals and its lead asset ALK001, a late-stage investigational therapy for Stargardt disease, which has no FDA-approved treatments and represents a significant market opportunity with an estimated 86,000 patients in the US. ALK001 has demonstrated a favorable long-term tolerability profile in over 400 patients with up to seven years of treatment exposure, and has shown potential to preserve visual function without negatively impacting night vision, dark adaptation, or color vision. The company's commercial execution for XDEMVY is strengthening, with the number of eye care professionals prescribing at a near-daily cadence doubling over the past year, retreatment rates advancing into the high teens, and unaided patient awareness of Demodex blepharitis climbing to approximately 30%. Tarsus Pharmaceuticals Inc (NASDAQ:TARS) is building a robust retina portfolio with two Phase III assets (IRX-101 and ALK001), creating potential commercial synergies with a concentrated physician base of about 3,500 retina specialists. The acquisition of Alkeus Pharmaceuticals carries a substantial upfront cost of $450 million (comprising $270 million in cash and $180 million in stock), plus up to $350 million in potential regulatory and commercial milestones, increasing financial risk. Top-line results for the pivotal Phase III NorthStar trial of ALK001 are not expected until the second half of 2029, meaning a long wait before potential approval and revenue generation from this significant investment. Tarsus Pharmaceuticals Inc (NASDAQ:TARS) faces intense competition in the Stargardt disease space, notably from a competitor with a head start in Phase III development, which could impact future market share. The company's increased full-year R&D expense guidance (now $190 million to $210 million, up from $115 million to $135 million) reflects higher spending, and management indicated that incremental costs from new acquisitions could delay profitability by a quarter or two beyond the previously anticipated 2027 timeline. The company expects normal seasonal slowdowns in the third quarter due to fewer physician office days, which could temper near-term revenue growth despite the raised annual guidance. The success of the ALK001 program is heavily dependent on the ongoing NorthStar trial, which is enrolling advanced disease patients, while the cleanest efficacy signals from prior studies were seen in pre-symptomatic and early-stage patients, creating uncertainty about the pivotal trial's outcome. Warning! GuruFocus has detected 2 Warning Sign with TARS. Is TARS fairly valued? Test your thesis with our free DCF calculator. Q: How does ALK-001 compare in efficacy to Tinlarebant, the Stargardt medication in Phase III trials that has a head start, and what differentiating factors could help it capture more market share? A: CEO Bobby Azamian noted that while Tarsus is likely going second to market, ALK-001 demonstrated effectiveness in two key dimensions: slowing disease progression as measured by atrophy and preserving visual acuity, particularly low-light visual acuity (LLVA), which is unique in the field. COO Sasha Nirvanan added that ALK-001 is designed to curtail toxic dimers without impacting the visual cycle, preserving night vision, dark adaptation, and color vision, with a strong safety profile across 400+ patients. CFO Jeff Barrow highlighted market research with 100 retina specialists indicating this differentiation supports a potential $1 billion-plus opportunity. Q: With two retinal launches on different timelines, how should we think about the differences in call points and the sequencing of the commercial build in terms of size and scope? A: Interim Chief Commercial Officer Neera Klais explained that while both assets serve underserved populations with high unmet need, the retina market involves a more concentrated physician base of about 3,500 specialists. The focus will be on securing broad access and launching efficiently into this concentrated audience, which is a different playbook from the Demodex blepharitis (DB) market but with a similar footprint. CEO Bobby Azamian added that there is significant synergy, with about 500 doctors serving IRX-101 and a subset of 2,000 likely to prescribe over 80% of Stargardt therapies. Q: What is the market opportunity for ALK-001, and how should we think about pricing and the durability of the visual benefit given the natural history of the disease? A: Neera Klais confirmed that the pricing range of $350,000-$500,000 is what Tarsus would consider for this asset, driven by its differentiated safety and tolerability profile. COO Sasha Nirvanan noted that the Phase II trials showed a statistically significant benefit in slowing the worsening of low-light visual acuity within two years, which is a more sensitive measure than best-corrected visual acuity (BCVA) and serves as a precursor to BCVA loss, providing physicians with a reliable tool to monitor disease progression. Q: Is there an opportunity for ALK-001 in geographic atrophy (GA), and is a second Phase III trial needed for approval or is it for commercial purposes? A: CEO Bobby Azamian clarified that while the acquisition includes the entire company, the focus and value ascribed are primarily on Stargardt disease, though the GA data provides a strong foundation. COO Sasha Nirvanan explained that the ongoing NorthStar Phase III trial is robustly designed and expected to provide compelling evidence for registration. The potential second Phase III trial is being considered as a risk mitigation and upside strategy, potentially focusing on younger and faster progressors, with discussions with the FDA still pending. Q: How do you square the pivotal population in NorthStar, which enrolls advanced disease, with the mechanism of action, and what reduction in atrophy would be considered clinically meaningful? A: COO Sasha Nirvanan stated that NorthStar is designed for advanced patients but also includes younger and progressive patients aged 8-45. The primary endpoint measures the rate of retinal lesion growth, a well-known and FDA-precedented endpoint. The Phase II data showed a robust 29% reduction in atrophic lesions compared to placebo, and the study is positioned to hit both primary and secondary endpoints. CEO Bobby Azamian added that the data package showed good signals across multiple Phase II studies in moderate, advanced, and early-stage patients. Q: Could the approval of a competitor like Tinlarebant affect enrollment in the NorthStar trial? A: COO Sasha Nirvanan expressed confidence that it would not. The NorthStar trial is being conducted globally at many sites and is already enrolling as expected, having started two months ago. By the time other products could be approved and launched, Tarsus expects to be well underway with enrollment, and there are many non-CRO sites that can be leveraged if needed. Q: Can you provide color on Xdemvy retreatment rates and the conversion rate from DTC website engagement to treated patients? A: Neera Klais noted that retreatment rates are maturing as expected, advancing into the high teens and stabilizing at about a 20% steady state. DB is a recurring condition, and patients with good initial experiences return when symptoms recur. On the DTC front, unaided awareness has climbed to 30% from 2% at launch, with one in three patients now recognizing Xdemvy by name. Website engagement is up 30%, and patients are asking for Xdemvy by name, with spending described as efficient and disciplined. Q: With the evolving pipeline, is there any shift in prioritization of programs, and what milestones would define success for the Alkeus acquisition over the next 12-24 months? A: CFO Jeff Barrow confirmed there is no pipeline shift, with a robust balance sheet allowing focus on existing programs, including the ocular rosacea program and the IRX-101 product expected to reach the market in the next two to three years. For ALK-001, key milestones include tracking patient enrollment in the NorthStar trial, with a potential interim analysis being discussed internally. Top-line data is expected in the second half of 2029. Q: The implied second-half revenue trajectory for Xdemvy looks conservative even with seasonality. Is there anything missing in terms of acceleration, and how should we think about profitability given increased R&D spend? A: CFO Jeff Barrow stated that the guidance is appropriate based on historical seasonality patterns, including summer vacations and holidays, with more robust growth expected in Q4. On profitability, he noted that while the company hasn't officially commented, taking the top end of revenue and bottom end of OpEx guidance suggests profitability in 2027. The incremental spend on Irenix and Alkeus could shift profitability by a quarter or two. Neera Klais added that the sales force for the new assets would be a dedicated team of 50-75 representatives. Q: How does the access and reimbursement timeline for the retinal assets compare to Xdemvy? A: Neera Klais explained that while the approach is different due to the rare disease nature, it is very similar in executiona differentiated value story with a focus on fast For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-07-30Agenus (AGEN) Earnings Expected to Grow: Should You Buy?
Zacks
Agenus (AGEN) Earnings Expected to Grow: Should You Buy?
The market expects Agenus (AGEN) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report, which is expected to be released on August 6, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This biotechnology company is expected to post quarterly earnings of $0.05 per share in its upcoming report, which represents a year-over-year change of +105%. Revenues are expected to be $34 million, up 32.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 40% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's p…Read full documentShow less
The market expects Agenus (AGEN) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report, which is expected to be released on August 6, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This biotechnology company is expected to post quarterly earnings of $0.05 per share in its upcoming report, which represents a year-over-year change of +105%. Revenues are expected to be $34 million, up 32.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 40% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Agenus, the Most Accurate Estimate is the same as the Zacks Consensus Estimate, suggesting that there are no recent analyst views which differ from what have been considered to derive the consensus estimate. This has resulted in an Earnings ESP of 0%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Agenus will beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Agenus would post earnings of $2.1 per share when it actually produced earnings of $1.02, delivering a surprise of -51.43%. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Agenus doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Another stock from the Zacks Medical - Biomedical and Genetics industry, Tarsus Pharmaceuticals, Inc. (TARS), is soon expected to post loss of $0.21 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of +56.3%. Revenues for the quarter are expected to be $165.62 million, up 61.3% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Tarsus Pharmaceuticals has been revised 439.7% down to the current level. Nevertheless, the company now has an Earnings ESP of -6.13%, reflecting a lower Most Accurate Estimate. When combined with a Zacks Rank of #4 (Sell), this Earnings ESP makes it difficult to conclusively predict that Tarsus Pharmaceuticals will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates two times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Agenus Inc. (AGEN) : Free Stock Analysis Report Tarsus Pharmaceuticals, Inc. (TARS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-07-29Tarsus Pharmaceuticals, Inc. (TARS) May Report Negative Earnings: Know the Trend Ahead of Q2 Release
Zacks
Tarsus Pharmaceuticals, Inc. (TARS) May Report Negative Earnings: Know the Trend Ahead of Q2 Release
Tarsus Pharmaceuticals, Inc. (TARS) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.21 per share in its upcoming report, which represents a year-over-year change of +56.3%. Revenues are expected to be $165.62 million, up 61.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 439.73% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A…Read full documentShow less
Tarsus Pharmaceuticals, Inc. (TARS) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.21 per share in its upcoming report, which represents a year-over-year change of +56.3%. Revenues are expected to be $165.62 million, up 61.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 439.73% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Tarsus Pharmaceuticals, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -6.13%. On the other hand, the stock currently carries a Zacks Rank of #4. So, this combination makes it difficult to conclusively predict that Tarsus Pharmaceuticals will beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Tarsus Pharmaceuticals would post a loss of$0.46 per share when it actually produced a loss of -$0.16, delivering a surprise of +65.22%. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Tarsus Pharmaceuticals doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Ultragenyx (RARE), another stock in the Zacks Medical - Biomedical and Genetics industry, is expected to report loss per share of $1.27 for the quarter ended June 2026. This estimate points to a year-over-year change of -8.6%. Revenues for the quarter are expected to be $181.01 million, up 8.7% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Ultragenyx has remained unchanged. Nevertheless, the company now has an Earnings ESP of -5.27%, reflecting a lower Most Accurate Estimate. This Earnings ESP, combined with its Zacks Rank #2 (Buy), makes it difficult to conclusively predict that Ultragenyx will beat the consensus EPS estimate. Over the last four quarters, the company surpassed EPS estimates just once. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Tarsus Pharmaceuticals, Inc. (TARS) : Free Stock Analysis Report Ultragenyx Pharmaceutical Inc. (RARE) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-05-24This Biotech Stock Is Up 355%. One Fund Added a $169 Million Position Last Quarter
Motley Fool
This Biotech Stock Is Up 355%. One Fund Added a $169 Million Position Last Quarter
On May 15, 2026, Deep Track Capital disclosed a new position in Alumis (NASDAQ:ALMS), acquiring 6,772,595 shares—an estimated $169.31 million trade based on quarterly average pricing. According to a May 15, 2026 SEC filing, Deep Track Capital reported acquiring 6,772,595 shares of Alumis (NASDAQ:ALMS) during the first quarter of 2026. The estimated transaction value was $169.31 million, based on the period’s average unadjusted closing price. As of March 31, 2026, the fund’s Alumis stake was valued at $149.20 million, reflecting both the purchase and stock price changes during the quarter. Top five holdings after the filing: As of Friday, shares of Alumis were priced at $22.02, up about 355% over the past year and well outperforming the S&P 500, which is up about 28% in the same period. Alumis develops clinical-stage biopharmaceutical products targeting autoimmune and neuroinflammatory diseases, with lead assets including ESK-001 and A-005. The firm operates a research-driven business model focused on advancing proprietary TYK2 inhibitors through clinical trials toward potential commercialization. It targets healthcare providers and patients affected by autoimmune disorders such as plaque psoriasis, systemic lupus erythematosus, and neurodegenerative diseases. Alumis is a biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory conditions. It leverages expertise in allosteric TYK2 inhibition to advance a pipeline of differentiated clinical candidates. With a focus on unmet medical needs, Alumis aims to establish a competitive edge through innovative science and targeted clinical development strategies. Deep Track has a history of making concentrated healthcare investments, and Alumis fits that playbook as a late-stage biotech with multiple shots on goal and several potentially value-defining catalysts over the next year.The story is increasingly centered on envudeucitinib, the company's TYK2 inhibitor for autoimmune diseases. Recent Phase 3 psoriasis data showed PASI 90 response rates of 68.0% and 62.1% by Week 24, with PASI 100 rates reaching 41.0% and 39.5%. Management says it remains on track to submit an NDA in the fourth quarter of this year, while potentially pivotal Phase 2b lupus data are expected in the third quarter.CEO Martin Babler said the results reinforce the drug's potential to "reshape the…Read full documentShow less
On May 15, 2026, Deep Track Capital disclosed a new position in Alumis (NASDAQ:ALMS), acquiring 6,772,595 shares—an estimated $169.31 million trade based on quarterly average pricing. According to a May 15, 2026 SEC filing, Deep Track Capital reported acquiring 6,772,595 shares of Alumis (NASDAQ:ALMS) during the first quarter of 2026. The estimated transaction value was $169.31 million, based on the period’s average unadjusted closing price. As of March 31, 2026, the fund’s Alumis stake was valued at $149.20 million, reflecting both the purchase and stock price changes during the quarter. Top five holdings after the filing: As of Friday, shares of Alumis were priced at $22.02, up about 355% over the past year and well outperforming the S&P 500, which is up about 28% in the same period. Alumis develops clinical-stage biopharmaceutical products targeting autoimmune and neuroinflammatory diseases, with lead assets including ESK-001 and A-005. The firm operates a research-driven business model focused on advancing proprietary TYK2 inhibitors through clinical trials toward potential commercialization. It targets healthcare providers and patients affected by autoimmune disorders such as plaque psoriasis, systemic lupus erythematosus, and neurodegenerative diseases. Alumis is a biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory conditions. It leverages expertise in allosteric TYK2 inhibition to advance a pipeline of differentiated clinical candidates. With a focus on unmet medical needs, Alumis aims to establish a competitive edge through innovative science and targeted clinical development strategies. Deep Track has a history of making concentrated healthcare investments, and Alumis fits that playbook as a late-stage biotech with multiple shots on goal and several potentially value-defining catalysts over the next year.The story is increasingly centered on envudeucitinib, the company's TYK2 inhibitor for autoimmune diseases. Recent Phase 3 psoriasis data showed PASI 90 response rates of 68.0% and 62.1% by Week 24, with PASI 100 rates reaching 41.0% and 39.5%. Management says it remains on track to submit an NDA in the fourth quarter of this year, while potentially pivotal Phase 2b lupus data are expected in the third quarter.CEO Martin Babler said the results reinforce the drug's potential to "reshape the psoriasis treatment landscape" and described envudeucitinib as a potential "pipeline in a pill" with opportunities across additional immune-mediated diseases.Financially, Alumis ended the quarter with $569.5 million in cash, cash equivalents, and marketable securities and expects that capital to fund operations into the fourth quarter of 2027.For long-term investors, the thesis is straightforward. If upcoming lupus data and the planned psoriasis filing go well, today's valuation could look conservative. If either disappoints, the stock's remarkable run may prove difficult to sustain. Before you buy stock in Alumis, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Alumis wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $477,813!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,320,088!* Now, it’s worth noting Stock Advisor’s total average return is 986% — a market-crushing outperformance compared to 208% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 24, 2026. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Guardant Health. The Motley Fool has a disclosure policy. This Biotech Stock Is Up 355%. One Fund Added a $169 Million Position Last Quarter was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-05-07Tarsus Pharmaceuticals, Inc. Q1 2026 Earnings Call Summary
Moby
Tarsus Pharmaceuticals, Inc. Q1 2026 Earnings Call Summary
XTENVI net product sales grew over 85% year-over-year, driven by a shift in physician behavior from treating only symptomatic cases to universal screening for collarettes. Management attributes growth to increasing depth of prescribing, with nearly half of the 15,000 target eye care physicians now prescribing at least once a week. The company is executing a 'repeatable playbook' for identifying underdiagnosed diseases with clear root causes, aiming to replicate XTENVI's success in new therapeutic categories. Market expansion is being fueled by evidence generation that links Demodex blepharitis to other conditions like chalazion and hordeolum, broadening the clinical utility for physicians. Operational momentum is supported by a direct-to-consumer campaign that is exceeding ROI benchmarks and driving a 40% quarter-over-quarter increase in high-value website engagement. Strategic positioning focuses on establishing XTENVI as the lasting standard of care, even as potential competitors enter the Phase II clinical landscape. Full-year 2026 revenue guidance of $670 million to $700 million assumes a seasonal rebound in Q2, more modest growth in Q3, and robust growth in Q4 as patients meet insurance deductibles. The deployment of a new Key Account Leader team in the third quarter is expected to catalyze incremental growth by targeting high-potential practices to further deepen utilization. Management expects steady-state retreatment rates to reach approximately 20%, with current rates already trending in the mid-to-high teens. Top-line data for the Phase II CALLIOPE trial in Lyme disease prevention is expected in 2027, while top-line data for the ocular rosacea program is anticipated in the first half of 2027. The base case for the Lyme disease program involves delivering a robust Phase II data set before potentially transitioning the asset to a partner for large-scale Phase III trials. Q1 results included a one-time $15 million regulatory milestone from partner Grand Pharma following TPO3 approval in Greater China. First-quarter performance was impacted by typical seasonal dynamics, including deductible resets and severe winter weather in the Northeast U.S. Gross margins are expected to remain stable at approximately 93% for the full year 2026. Management noted that while China royalties are expected long-term, they will not be meaningful in 2026 or 2027 as the par…Read full documentShow less
XTENVI net product sales grew over 85% year-over-year, driven by a shift in physician behavior from treating only symptomatic cases to universal screening for collarettes. Management attributes growth to increasing depth of prescribing, with nearly half of the 15,000 target eye care physicians now prescribing at least once a week. The company is executing a 'repeatable playbook' for identifying underdiagnosed diseases with clear root causes, aiming to replicate XTENVI's success in new therapeutic categories. Market expansion is being fueled by evidence generation that links Demodex blepharitis to other conditions like chalazion and hordeolum, broadening the clinical utility for physicians. Operational momentum is supported by a direct-to-consumer campaign that is exceeding ROI benchmarks and driving a 40% quarter-over-quarter increase in high-value website engagement. Strategic positioning focuses on establishing XTENVI as the lasting standard of care, even as potential competitors enter the Phase II clinical landscape. Full-year 2026 revenue guidance of $670 million to $700 million assumes a seasonal rebound in Q2, more modest growth in Q3, and robust growth in Q4 as patients meet insurance deductibles. The deployment of a new Key Account Leader team in the third quarter is expected to catalyze incremental growth by targeting high-potential practices to further deepen utilization. Management expects steady-state retreatment rates to reach approximately 20%, with current rates already trending in the mid-to-high teens. Top-line data for the Phase II CALLIOPE trial in Lyme disease prevention is expected in 2027, while top-line data for the ocular rosacea program is anticipated in the first half of 2027. The base case for the Lyme disease program involves delivering a robust Phase II data set before potentially transitioning the asset to a partner for large-scale Phase III trials. Q1 results included a one-time $15 million regulatory milestone from partner Grand Pharma following TPO3 approval in Greater China. First-quarter performance was impacted by typical seasonal dynamics, including deductible resets and severe winter weather in the Northeast U.S. Gross margins are expected to remain stable at approximately 93% for the full year 2026. Management noted that while China royalties are expected long-term, they will not be meaningful in 2026 or 2027 as the partner works to secure payer coverage. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management expressed confidence in XTENVI's established safety and efficacy profile as the standard of care. They noted that while other companies are entering the space, XTENVI's robust evidence base and physician feedback position it strongly against emerging clinical-stage assets. Peak sales projections assume a steady-state retreatment rate of approximately 20% of total prescriptions. Growth is also predicated on expanding the addressable market through new use cases, such as preoperative cataract screening and treating associated conditions like chalazion. The company is focused on achieving Phase III readiness with the current 700-participant Phase II trial. Management indicated that while they are advancing the program independently now, the asset may be better suited for a larger partner to execute the vaccine-like Phase III requirements. Management expects to exit the year with a GTN range of 43% to 45%. They clarified that retreatment prescriptions do not significantly change the net price realization, as these patients still require prior authorizations and copay support. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.
Investor releaseQuarter not tagged2026-05-07Tarsus Pharmaceuticals Q1 Earnings Call Highlights
MarketBeat
Tarsus Pharmaceuticals Q1 Earnings Call Highlights
Interested in Tarsus Pharmaceuticals, Inc.? Here are five stocks we like better. XDEMVY showed strong commercial momentum, delivering $145.4 million in Q1 net product sales with expanding prescribing depth and management reaffirming 2026 net product sales guidance of $670–$700 million and long-term peak-sales potential of about $2 billion. Pipeline advancement: Tarsus initiated a ~700-participant Phase II trial (Calliope) of TP-05 for Lyme disease prevention and began a Phase II core study of TP-04 for ocular rosacea, with topline data for both expected in the first half of 2027. Collaboration milestone in China: The company recognized $16.7 million in license and collaboration revenue, including a one-time $15 million regulatory milestone from Grand Pharma’s TP-03 approval in Greater China, though meaningful royalties aren’t expected in 2026–2027 as the partner seeks payer coverage. 3 Biotech Catalysts Present Major Opportunity Tarsus Pharmaceuticals (NASDAQ:TARS) reported first-quarter 2026 results highlighted by continued commercial momentum for XDEMVY and progress across its development pipeline, including newly initiated and advancing Phase II programs in Lyme disease prevention and ocular rosacea. Chief Executive Officer and Chairman Bobby Azamian said the company is “off to a strong start in 2026,” pointing to growth across metrics the company tracks, including “the number of writers, depth of prescribing, awareness, and evidence generation.” He said the company remains on track with its full-year outlook and reiterated a long-term view that XDEMVY could reach “blockbuster status in the next couple of years” with “$2 billion in peak sales potential.” → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? In the first quarter, XDEMVY delivered more than $145 million in net product sales. Chief Financial Officer and Chief Strategy Officer Jeff Farrow reported net product sales of $145.4 million, describing demand as strong despite typical first-quarter headwinds such as deductible resets, higher out-of-pocket costs, and “some impact from severe winter weather, particularly in the Northeast.” Farrow added that third-party data showed peers had double-digit prescription declines while Tarsus experienced low single-digit declines, and he said prescription trends “rebounded to all-time highs” as the company entered the second quarter. Chief Commerci…Read full documentShow less
Interested in Tarsus Pharmaceuticals, Inc.? Here are five stocks we like better. XDEMVY showed strong commercial momentum, delivering $145.4 million in Q1 net product sales with expanding prescribing depth and management reaffirming 2026 net product sales guidance of $670–$700 million and long-term peak-sales potential of about $2 billion. Pipeline advancement: Tarsus initiated a ~700-participant Phase II trial (Calliope) of TP-05 for Lyme disease prevention and began a Phase II core study of TP-04 for ocular rosacea, with topline data for both expected in the first half of 2027. Collaboration milestone in China: The company recognized $16.7 million in license and collaboration revenue, including a one-time $15 million regulatory milestone from Grand Pharma’s TP-03 approval in Greater China, though meaningful royalties aren’t expected in 2026–2027 as the partner seeks payer coverage. 3 Biotech Catalysts Present Major Opportunity Tarsus Pharmaceuticals (NASDAQ:TARS) reported first-quarter 2026 results highlighted by continued commercial momentum for XDEMVY and progress across its development pipeline, including newly initiated and advancing Phase II programs in Lyme disease prevention and ocular rosacea. Chief Executive Officer and Chairman Bobby Azamian said the company is “off to a strong start in 2026,” pointing to growth across metrics the company tracks, including “the number of writers, depth of prescribing, awareness, and evidence generation.” He said the company remains on track with its full-year outlook and reiterated a long-term view that XDEMVY could reach “blockbuster status in the next couple of years” with “$2 billion in peak sales potential.” → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? In the first quarter, XDEMVY delivered more than $145 million in net product sales. Chief Financial Officer and Chief Strategy Officer Jeff Farrow reported net product sales of $145.4 million, describing demand as strong despite typical first-quarter headwinds such as deductible resets, higher out-of-pocket costs, and “some impact from severe winter weather, particularly in the Northeast.” Farrow added that third-party data showed peers had double-digit prescription declines while Tarsus experienced low single-digit declines, and he said prescription trends “rebounded to all-time highs” as the company entered the second quarter. Chief Commercial Officer Aziz Mottiwala attributed performance to three main drivers: Increasing depth of prescribing Expansion of the patient funnel Ongoing evidence generation → A Prada Payday: Is AMC Back in Style? Mottiwala said that in the first quarter, nearly half of Tarsus’ 15,000 target eye care physicians prescribed XDEMVY at least once per week, up about 10% from the fourth quarter of 2025. He also said retreatment rates have increased “to the mid-teens range” as physicians implement long-term management protocols, with Tarsus continuing to expect steady-state retreatment of roughly 20%. On direct-to-consumer efforts, Mottiwala said the DTC campaign is generating an improving return on investment that is “exceeding our expectations and is at the higher end of benchmarks.” He pointed to “millions of visitors” to xdemvy.com and said “high-value engagement,” including quiz completion and use of the Find a Doctor tool, was up nearly 40% quarter-over-quarter. He said the company plans a “creative refresh” and expanded disease-state messaging in the coming weeks. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Management emphasized that evidence generation is intended to expand how physicians identify and treat Demodex blepharitis (DB). Mottiwala highlighted data presented at the American Society of Cataract and Refractive Surgery (ASCRS) meeting on the association between DB and chalazion and hordeolum. He said the dataset showed that more than 70% of assessed patients had underlying DB, with even higher rates in recurrent cases, and that physicians are responding by proactively screening and treating these patients. Azamian said that, in his discussions with eye care providers, some are now screening broadly rather than focusing only on the most symptomatic cases. He also said he is hearing that physicians are treating “regardless of symptoms” in certain settings and that evidence such as the chalazion example adds “lots of reasons to treat,” contributing to an expanding addressable market. Tarsus said it is preparing to deploy Key Account Leaders (KALs) focused on high-volume and high-potential practices. Mottiwala described this as a “highly targeted investment” and said the KAL team is expected to contribute incremental growth starting in the second half of 2026. Responding to a question on timing and impact, management said the KAL initiative involves roughly 17 to 20 people and is designed to increase depth of prescribing at practices that already show strong utilization but still have room to expand. The company said KALs are expected to be “out there in the third quarter,” with management expecting to see an impact as they begin engaging target accounts, while noting seasonality is driven by patient-flow dynamics. Farrow reiterated full-year 2026 guidance, including: Net product sales: $670 million to $700 million SG&A: $545 million to $565 million (including about $40 million in stock-based compensation) R&D: $115 million to $135 million (including about $20 million in stock-based compensation) Gross margin: approximately 93% Farrow said 2026 quarterly performance is expected to follow patterns seen previously: strong growth in the second quarter, more modest growth in the third quarter, and robust growth in the fourth quarter, which he linked to deductible dynamics and end-of-year spending such as flexible spending accounts. Outside of product sales, Farrow reported $16.7 million in license fees and collaboration revenue, including a one-time $15 million regulatory milestone from partner Grand Pharma following the approval of TP-03 for DB in Greater China, as well as approximately $1.7 million related to required China withholding tax. While the company expects royalties over time, Farrow said they are not expected to be meaningful in 2026 or 2027 as Grand Pharma seeks payer coverage ahead of a commercial launch planned for later this year. On gross-to-net, Farrow said the company will no longer provide quarterly gross-to-net updates now that it has moved to full-year revenue guidance. However, he said the company remains comfortable exiting the fourth quarter in the “43% to 45% range” and expects to be within that range for the year. He also said refill prescriptions are “not likely to change” gross-to-net dynamics materially because refills still generally require prior authorization and may also involve co-pay assistance. Tarsus also discussed progress in its pipeline, which Azamian framed as part of a broader “disciplined, repeatable playbook” focused on diseases with clear root causes and unmet need. In Lyme disease prevention, Azamian said the company initiated Calliope, an approximately 700-participant Phase II trial of TP-05. Enrollment is “progressing well,” with the first wave of participants already dosed, and topline data is expected in the first half of 2027 to support readiness for a Phase III trial. Farrow described Lyme disease as the most common vector-borne disease in the U.S. and said TP-05 is an oral, on-demand investigational approach designed to potentially kill ticks before disease transmission occurs. Asked about partnering and the regulatory path, Azamian said the company’s “base case” is that TP-05 may be “better in someone else’s hands as it goes to phase III,” adding that Tarsus aims to deliver a robust Phase II dataset and FDA clarity before engaging potential partners. He said the FDA has been collaborative and that Phase III could resemble a large vaccine-like trial, with the specifics depending on Phase II results. In ocular rosacea, Azamian said Tarsus has initiated a Phase II core study of TP-04, a sterile investigational ophthalmic gel designed to treat Demodex mites. He described ocular rosacea as underdiagnosed and affecting an estimated 15 million to 18 million Americans, with no FDA-approved treatments. He said topline data is expected in the first half of 2027. In response to questions on disease biology and trial endpoints, Azamian said the company believes the “majority of patients with OR have Demodex,” though it is harder to measure than DB, and that the trial is evaluating endpoints tied to ocular rosacea signs including telangiectasias and erythema. He said Tarsus has aligned with the FDA on the need to assess those endpoints and expects success to be defined by improvement in one of them. In closing remarks, Azamian said Tarsus is executing on what he called “one of the most successful launches in eye care,” while applying the same approach across its pipeline to “replicate the success of XDEMVY and establish Tarsus as a leader in creating new standards of care.” Tarsus Pharmaceuticals, Inc is a clinical‐stage biopharmaceutical company focused on developing novel therapies for diseases of the eye and ocular surface. The company's research platform centers on neuro‐effector modulation to address underlying disease mechanisms rather than solely treating symptoms. Tarsus's lead candidate, OC-01 (varenicline solution), is an intranasal formulation in Phase 3 development for the treatment of dry eye disease, a condition affecting millions worldwide and associated with significant patient discomfort and reduced quality of life. In addition to its dry eye program, Tarsus is advancing preclinical and early‐stage programs targeting other ophthalmic indications, including allergic conjunctivitis and retinal disorders. The article "Tarsus Pharmaceuticals Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

