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 and all participants are in listen-only mode.
After the speakers' presentation, there will be a question-and-answer session. 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. 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.
Bobby 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 eyecare 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 eyecare 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 eyecare 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 eyecare.
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 the cornerstone from which we're building a leading eyecare company, one with the capabilities, 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 eyecare 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—eyecare 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.
Eyecare 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 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're also seeing retreatment rates advancing to 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 coinfestations. 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 eyecare practices; stronger evidence and field execution helps 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 eyecare. With that, I'll turn it over to Sesha.
Sesha 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. 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 3 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-luminance visual acuity. Coupled with the compelling data from TEASE 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 3 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.
Jeff Farrow
Thank you, Sesha, and good morning, everyone. All around, this was another outstanding quarter for Tarsus.
We delivered record XDEMVY revenue, continued expanding our leadership in eyecare, and announced 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 to $705 million from our prior guidance of $670 to $700 million. This increase reflects our confidence in the underlying strength of the business.
As we've previously discussed, we expect the quarterly revenue progression throughout the remainder of the year to reflect normal seasonality of the eyecare market. The summer period typically includes fewer physician office visit days 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 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. That 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 tied to 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 healthcare investors, including several shareholders of Alkeus.
This transaction reflects the disciplined strategy 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. 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.
Bobby 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 eyecare, created extraordinary momentum for our business, and most importantly expanded what's possible for Tarsus.
Today's announcement is another important step on that journey. Together with our other retina acquisition, IRX-101, it strengthens our retina portfolio and reinforces our ambition to build one of the most innovative and differentiated companies in eyecare.
We're incredibly excited about the opportunity ahead. Operator, please open the line for questions.
Operator
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 Greg Szabados of Mizuho. Your line is open.
Ryan Rieth
Hey, good morning. This is Ryan Rieth today for Greg Szabados.
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 3 trials for Belite 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.
Bobby Azamian
Thank you, Ryan. This is Bobby.
We're really excited about this asset. As mentioned, we really surveyed the landscape and found, I think, 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 the overall profile, we see some things that can really change the course of this disease, that demonstrated effectiveness in a couple of dimensions that are really important to patients: both the progression of the disease as measured by atrophy and the progression of the disease as 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 7 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.
Sesha Neervannan
Thank you, Bobby. Thanks for the 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 differentiating 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 perturbed. That's precisely what this medicine does.
It's actually shown in the data that we don't see any night vision adaptations, or color disturbances, and a very, very good safety profile, safety and tolerability profile. We think this medicine will differentiate itself on those properties, and it's very important for the patients, especially in a blinding disease, to not impact the visual cycle.
Jeff Farrow
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, and just a really nice safety profile. We surveyed about 100 retinal docs, and based on that, we really think that this is a billion-dollar-plus opportunity based on that differentiation there.
Ryan Rieth
Great. All right, thanks, guys.
Operator
Thank you. Our next question comes from Eddie Hickman of Guggenheim Securities.
Your line is open.
Eddie Hickman
Hey, guys, good morning, and thanks for the question, and congrats on all the progress and the deals. Now that you're building towards two retinal launches on different timelines, can you talk about the difference in call points that you need to build out and how we should think about the sequencing of that commercial build in terms of size and scope?
Appreciate it.
Bobby Azamian
Thank you. Eddie, I'll start, and I'll pass to our Chief Commercial Officer, Neera.
It's a great point. We're entering a new field, retina.
We're really excited to have now two Phase 3 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 eyecare provider and really educating.
I know we'll do that here as well. We have two drugs in Phase 3, one, IRX-101's a little bit ahead of ALK-001, I think it positions us well.
I'll pass to Neera to talk about some of the synergy she sees.
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 eyecare 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 these physicians out there today. Our focus will be on securing broad access and launching efficiently into a concentrated physician audience.
It's a different playbook than with DB, but very similar footprint. As we've proven that we can execute, and we're really excited about this opportunity.
Bobby Azamian
The other thing I'd point out
Neera Clase
is
Bobby Azamian
there's a lot of overlap in the call point here. About 3,500 doctors we'll be serving with IRX-101 that are doing IVTs, and then a subset of those, actually 2,000, are prescribing, we think or likely to prescribe, over 80% of the Stargardt's therapies here.
That presents some real synergy in terms of the sales force itself that we'll be building here.
Eddie Hickman
Got it. In terms of access, is that the same timeline as XDEMVY in terms of sort of getting payer reimbursements set up?
Is 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.
Bobby Azamian
The other thing, I'll have Liz Yeu, our CMO, talk about, we're a 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 eyecare provider landscape here.
Liz Yeu
Thank you, Bobby. When we think about the patients that we're taking care of, certainly taking a view of it from the patient perspective, and while most of the diseases that we as eyecare 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 progressors, half of them actually go blind within 7 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, but it's going to be primed by those primary eyecare physicians who are seeing them because of those complaints, failed vision tests, or because they're coming in for glasses.
They will be then diagnosed by the retina specialist, but 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 the evidence.
Eddie Hickman
Great, thank you so much for that color.
Operator
Thank you. Our next question comes from Jason Gerberry of Bank of America.
Your line is open.
Jason Gerberry
Hey, guys. Thanks for taking my questions.
I'm just trying to think about just, A, the market opportunity here. I think you said something like 30-something-thousand patients.
Belite's talked about a pricing in the $350k to $500k territory, trying to get a sense of what proportion of these patients are actually under the care of a retinal specialist and is in addressable sort of market? Secondly, just a question around how to think about the use of natural history.
On BCVA changes over, say, a 2-year period versus lesion growth, I think the competitor had flagged, you typically would lose one letter every 2 years or so. Just wondering how you think about the need for longer-term follow-up and sort of the durable BCVA benefit.
Thanks.
Neera Clase
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 growth file 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 into this. As you mentioned, the natural history is a good way to create that value over time and to position this for optimal pricing and durability.
With that, I'll turn it over to Sesha to provide additional color.
Sesha Neervannan
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 2 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, and so 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're very measurable.
Operator
Our next question comes from Lachlan Hanbury-Brown of William Blair. One moment.
Lachlan Hanbury-Brown
Hey. Just wondering if the team is there.
I think they cut out on that last question.
Bobby Azamian
We're here.
Lachlan Hanbury-Brown
Great. Thanks for questions and congrats on the deal, I guess.
Maybe a couple quick ones, just 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, wondering if you're thinking there's an opportunity there, if you ascribe any value to that or it's really just about Stargardt. Then maybe a second question.
You said you're thinking about a potential second Phase 3 for approval. I just wanted to clarify: are you expecting a second Phase 3 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?
Bobby Azamian
Thank you, Lachlan. I'll take the first part of that, and Sesha will take the second part.
We really looked at this in terms of the acquisition as focused on Stargardt. We see that there's been over 400 patients treated including GA study and that provides a really strong foundation.
While we're acquiring the entire company, our focus is really on Stargardt in terms of the value ascribed here. Sesha, pass to you.
Sesha Neervannan
Thank you, Bobby. As I mentioned, our current Phase 3 trial, NorthStar, is a very robustly designed trial and in patients in a broad set of patients.
In fact, it's potentially the largest progressive prospective trial that's been conducted in Stargardt disease, and 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 2 data as well.
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 effect size with the fast progressors or other ways to enhance it.
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. Stay tuned for how that progresses.
Operator
Thank you.
Lachlan Hanbury-Brown
Thanks.
Operator
Our next question comes from Mazen Mroueh of Oppenheimer. Your line is open.
Mazahir Alimohamed
Thank you. Thanks, Bobby and team, for taking our questions.
I think one for my side is that I think when we were looking, 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. How do we square the pivotal population with the mechanism?
Is the expectation just that a slower atrophy front at the lesion margin? I guess a second follow-up to that is that if that's the case, then what reduction there do you consider clinically meaningful?
Sesha Neervannan
Thank you. Thank you, Mazen, for the question.
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 so it really capturing those patients in the disease state.
The lesion growth of atrophic lesion, which is a very well-known and a precedented endpoint by the FDA for approval. That's how it is designed.
The TEASE data showed that there's a very robust reduction of that atrophic lesions in the trials. We saw about 20 29% reduction compared to placebo.
I think this study is designed to hit on the primary endpoints that and secondary endpoint of low-light visual acuity that is precedented with the FDA and really it's positioned to win on those endpoints.
Bobby Azamian
I'll just add, when we looked at the data package here, we saw, really good signals throughout multiple Phase 2 studies in both moderate disease, advanced disease, and in some early patients. We got confidence across the spectrum of disease that Sesha describing here in NorthStar.
Mazahir Alimohamed
Got it. Thank you.
Then I guess with that, if tinlarebant is approved, could that affect trial enrollment going forward?
Sesha Neervannan
We don't think so. 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 the trial 2 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-US sites that we can also leverage even beyond that.
Mazahir Alimohamed
Got it. Thank you for taking our questions.
Operator
Thank you. Our next question comes from Francois 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 in terms of website engagement, what that conversion rate is to treated patients? Thank you.
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. We're seeing exactly what we want: patients who actually had 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%, and if you think about it, where we started, we were at 2%. Now one in every three patients can recognize XDEMVY by name, so that's really quite exceptional velocity for a disease that most people really never heard of.
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 being very efficient and very disciplined, and the returns continue to support the continued investments.
Thank you.
Operator
Thank you. Our next question comes from Matthew Caufield of H.C.
Wainwright. Your line is open.
Hi,
Matthew Caufield
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?
Then separately, regarding the Alkeus acquisition, what milestones would define success over the next 12 to 24 months, considering the Phase 3 NorthStar top line are expected later into second half 2029, just in terms of judging whether the acquisition is tracking above or below your near-term expectations? Thanks a lot.
Jeff Farrow
Good morning, Matthew. 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're really excited about the ocular rosacea program.
You highlighted the Lyme, which our baseline assumption is to partner with a Phase 3-ready package. Also the Irenix product is something that we're really excited about getting into the market here in the next couple, 3 years.
We're fully committed to the pipeline including the Alkeus Phase 3 study. Then on sort of the data flow on the Alkeus or the ALK-001, in essence, one of the things we'll obviously be tracking is the 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 discussing internally and see if that makes sense to do, but that is a potential option for us to do.
Then, of course, will be the data top-line data, which we expect to be sometime in the second half of 2029.
Matthew Caufield
Excellent. Thank you, guys.
Really exciting to see all the updates.
Jeff Farrow
Thank you.
Operator
Thank you. Our next question comes from Anthea Lee of Jefferies.
Your line is open.
Anthea Lee
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? Then, secondly, how are you thinking about profitability now that you need to probably ramp up R&D spend for these two new assets and then also expand the sales force?
I think consensus has Tarsus becoming EBIT positive in 2027. Do you still think that's fair?
Thank you.
Jeff Farrow
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.
We stand by that guidance. Of course, we always have an opportunity to update that in subsequent quarters, but right now we're pleased with how we've moved that up, and 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 time frame of when those data turnover.
Shift our ability to go profitable maybe perhaps by a quarter or two. Then
Neera Clase
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 could think about a different sales force of between 50 to 75 complete team.
Anthea Lee
Great. Thank you so much.
Operator
This concludes our question-and-answer session and today's conference call. Thank you for participating, and you may now disconnect.