Q2 2026 Tarsus Pharmaceuticals Inc Earnings Call

August 6, 2026

Speaker #1: 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.

Speaker #2: Thank you. Before we begin, I encourage everyone to visit the investor section of the Tarsus website to view the press releases issued today and related materials we will be discussing today.

Speaker #2: Joining me on the call are Bobby Azamian, our Chief Executive Officer and Chairman; Meera Clase, our Interim Chief Commercial Officer; Sesha Neervannan, our Chief Operating Officer; and Jeff Farrow, our Chief Financial Officer and Chief Strategy Officer.

Speaker #2: 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 statement.

Speaker #2: 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.

Speaker #2: 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.

Speaker #3: Hello and thank you for joining us. Today is an important day for Tarsus. We're reporting another exceptional quarter for Extempi and announcing the acquisition of Alkios Pharmaceuticals and Gilda Retinol, or ALK-001, a late-stage investigational therapy for Stargardt disease.

Speaker #3: When we launched Extempi, we believed Demonex 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 could fundamentally change patient care while building a leading eye care company.

Speaker #3: Extempi continues to prove that thesis. Nearly 3 years after launch, more than 700,000 patients have been treated. Extempi 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.

Speaker #3: This quarter alone, Extempi generated approximately $174 million in net product sales, representing more than 69% year-over-year growth. Extempi has never been stronger, and we believe we are still in the early stages of realizing its full commercial opportunity.

Speaker #3: What's more, Extempi 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: I would like to take a moment and thank the Alkios team for all their passion and commitment in developing ALK-001, a truly novel medicine.

Speaker #3: To date, they have developed one of the most robust clinical datasets, and we believe ALK-001 has the potential to preserve vision longer in patients suffering from Stargardt disease.

Speaker #3: Extempi 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.

Speaker #3: And with today's announcement, we took an important step on this journey. This acquisition is expected to build upon the commercial success of Extempi and, with the addition of ALK-001, create one of the most exciting pipelines in eye care and beyond.

Speaker #3: 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 Meera Clase, our Interim Chief Commercial Officer, to her first earnings call.

Speaker #3: Meera has been instrumental in building our commercial organization and ensuring the ongoing success of Extempi and we are thrilled to apply her leadership and expertise to this new chapter.

Speaker #3: Meera, over to you.

Speaker #4: 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 Extempi on the path to more than $2 billion in potential peak sales.

Speaker #4: As Bobby mentioned, Extempi 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.

Speaker #4: These three priorities are reinforcing one another, which is exactly why Extempi continues to outperform. The clearest evidence is the change we're seeing in ECP behavior.

Speaker #4: 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.

Speaker #4: And the numbers reinforce the acceleration we are seeing. Over the past year, the number of ECPs prescribing Extempi at a near-daily cadence has doubled, and our top doctors have continued to increase prescribing month after month.

Speaker #4: That's an important shift. It signals that the market has moved beyond initial adoption and toward 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.

Speaker #4: 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.

Speaker #4: Recent studies have shown that DB is common in patients with talasia, which further reinforces Extempi as the standard of care over tea tree oil, and highlights the potential infection risk associated with Demodex and bacterial co-infestation.

Speaker #4: 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.

Speaker #4: In addition, our key account leaders, or CALs, 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.

Speaker #4: 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 Extempi prescribing over the next year and beyond.

Speaker #4: This strongly signals continuing 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.

Speaker #4: 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.

Speaker #4: As a result of these efforts, many patients are now asking for Extempi by name. We've also seen a 19% increase in Extempi.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.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: 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, help physicians identify and treat more patients, and positive clinical experience further reinforces confidence and adoption.

Speaker #4: 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 Extempi has never been stronger.

Speaker #4: Its continued success is not only driving growth; it is creating the foundation for Tarsus to invest in programs like Gildu Retinol and expand our impact for patients across eye care.

Speaker #4: With that, I'll turn it over to Sesha.

Speaker #2: Thank you, Neera. This is a momentous day for Tarsus and our mission to serve patients. We believe ALK001 is the most compelling program in development for Stargardt disease, and as we heard from Bobby, it has the potential to become a foundational medicine for patients with no approved therapies today.

Neera Clase: 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.

Speaker #2: 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.

Speaker #2: 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.

John Cena our celebrity spokesperson brings credibility and authenticity through his own experience with TV while our new unbranded DTC campaign. Featuring bury. 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.

Speaker #2: 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 the age of 20 or expected to become legally blind within seven years.

Speaker #2: Seven 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. ALK001 is an investigational modified vitamin A analog designed to slow the formation of these toxic byproducts while preserving the normal visual cycle.

We've also seen a 19% increase in high-value actions on the extended.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 EP.

Neera Clase: 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, 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.

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 DCC campaign.

Speaker #2: 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.

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 envision.

Greater awareness brings more important patients into eye care practices.

Stronger, evidence and field, execution, Health, positions, identify and treat more patients.

Speaker #2: As you can see here, the TE studies showed ALK001's potential to preserve the visual cycle and acuity slow retinal atrophy and its unmatched long-term tolerability profile.

And positive clinical experience, further reinforces confidence and adoption.

When I look at the business today, I see a potential of 2 billion dollar opportunity. That is unfolding exactly as we plan.

Neera Clase: 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 Seshasayee.

Speaker #2: Together, these studies give us confidence that ALK001 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.

That's why my confidence in extending has never been stronger. Its continued success is not only driving growth, it is creating the foundation for Tarsus to invest in programs like Gilder retinol and expand our impact for patients across. I care

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 Bobak, 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.

With that, I'll turn it over to station.

Thank you, dear.

Speaker #2: ALK001 has been evaluated in more than 400 patients, demonstrating a favorable tolerability profile and with treatment exposure extending up to seven years. This is exactly the type of program we look for.

This is a momentous day for ptosis and our mission to serve patients.

Speaker #2: 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.

We Believe ALK 00001 is the most compelling program in development for Star disease. And as we heard from Bobby, it has a potential to become a foundational medicine for patients with no approved therapies today.

Speaker #2: Turning to next steps in the program, North Star, the ongoing phase three study, is designed to demonstrate that ALK001 can slow disease progression in patients with Stargardt disease.

For that is a serious inherited retinal disease. That often begins in childhood or adolescence with more than 36,000 diagnosed patient 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.

Speaker #2: 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.

Solar guard is caused by a genetic mutation. That leads to formation of toxic. Vitamin A divers known as this retinoids.

These toxic doors can damage. The retinal cells responsible for central vision and over time can cause blindness.

Speaker #2: And the secondary endpoint will assess a key aspect of visual function change in low luminescence visual acuity. Coupled with the compelling data from TE trials, ALK001 is expected to generate a differentiated and the most robust clinical dataset in Stargardt disease.

Sesha Neervannan: 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 phase studies showed ALK-001's potential to preserve the visual cycle and acuity, slow retinal atrophy, and its unmatched long-term tolerability profile.

The consequences can be devastating.

Half of patients diagnosed before age of 20 or expected to become legally blind within 7 years.

7 years. That's a reality facing many children, and young adults, living with stronger disease. Today,

Speaker #2: 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 three trial to support approval.

And it's also the urgency for this program.

ALK 00001 is an investigational modified vitamin A analog designed to slow the formation of these toxic byproducts, while preserving the normal visual cycle.

Speaker #2: The trial to be discussed with the FDA is Envision to focus on younger and faster progressors and include additional exploratory endpoints. We believe ALK001 has a potential to become a foundational treatment for patients with Stargardt disease, one which can blind a child within seven years.

It has the potential to address the dimensions that matter most to patients.

Slowing the progression of a blinding disease and preserving visual function.

Speaker #2: ALK001 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.

Today, 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.

Sesha Neervannan: 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.

As you can see here, the team studies showed a Elkay 001 potential to preserve the visual cycle and Equity slow retinal atrophy, and its unmatched long-term tolerability profile.

Speaker #2: Jeff, over to you.

Speaker #3: Thank you, Sesha, and good morning, everyone. All around, this was another outstanding quarter for Tarsus. We delivered reckless MD revenue, continued expanding our leadership in eye care, and advanced another important step in our long-term growth strategy through the acquisition of Irenics and today's announced pending acquisition of Alkias.

Together these studies. Give us confidence. That ALK 00001, can be a breakthrough medicine that can potentially prevent the progression of star guard disease.

As with any chronic therapy, especially 1 that impacts Pediatric and Adolescent patients, that may ultimately be taken for a lifetime. The long-term safety profile is Paramount.

Speaker #3: In the second quarter, Xtendi product sales were 173.9 million dollars, representing more than 69% growth year over year, and approximately 20% growth quarter over quarter.

People exposure extending up to seven years.

This is exactly the type of program we look for.

Differentiated disease, modifying approach.

Speaker #3: Gross margins were flat at approximately 93%, and we ended the quarter with cash, cash equivalents, and marketable securities of 449.7 million dollars. For additional details on our Q2 financial performance, please refer to the earnings release we issued today.

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.

Sesha Neervannan: 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 phase 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 H2 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.

Notre. The ongoing safety study is designed to demonstrate that ALK 001 can flow the disease progression in patients with sard disease.

Speaker #3: Turning to guidance, we have updated our outlook for the remainder of 2026 and increased Xtendi full year product sales guidance to 685 to 705 million dollars, from our prior guidance of 670 to 700 million dollars.

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.

Speaker #3: 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.

Coupled with the compelling data from piece trials. ALK 0001 is expected to generate a differentiated and the most robust clinical data set in Shard disease,

Speaker #3: The summer period typically includes fewer physician office delays, due to vacations, holidays, and conferences, and we expect tamper growth in the. 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.

the program has been developed with the FDA and we anticipate Topline results in the second half of 2029.

Sesha Neervannan: 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've never had, an investigational medicine with the potential to meaningfully slow progression of this blinding disease. Jeff, over to you.

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 info.

Speaker #3: Move to operating expenses. We continue to expect gross margins of approximately 93% and SG&A expenses of 545 to 565 million dollars. We now expect full-year R&D expense to be in the range of 190 million to 210 million dollars, an increase from a previous guidance of 115 million to 135 million dollars.

We Believe ALK 001 has a potential to become a foundational treatment for patients with siargao disease 1 which can blind a child within 7 years.

ALK-0001 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 give these patients something they've never had and investigational medicine with the potential to meaningfully slow progression of this grinding disease.

Speaker #3: This increase reflects the upfront consideration of 75 million dollars for the acquisition of Irenics Medical. This guidance does not include the pending acquisition of Alkias.

Just over to you.

Jeff Farrow: Thank you, Sesha, and 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 Q2, 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 to $705 million from our prior guidance of $670 to $700 million.

Thank you, sea and good morning everyone.

All around. This was another outstanding quarter for Tarsus.

Speaker #3: Turning to the financial terms of the Alkias transaction, the upfront consideration is 450 million dollars consisting of 270 million dollars in cash and 180 million dollars in Tarsus Common Stock.

We delivered record, extended the revenue, continued expanding our leadership. And I care, and another important step in our long-term growth strategy is through the acquisition of IriNex and today's announced pending acquisition of Alkas.

Speaker #3: The transaction includes up to 350 million dollars in potential must-downs 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 the second quarter, extend the net product sale for 173.9 million. Representing more than 69% growth, year-over-year, and approximately, 20% growth for a over quarter.

Gross margins were flat at approximately 93%.

Speaker #3: In addition, we considered 125 million dollars through a private placement financing from a syndicate of leading healthcare investors including several shareholders of Alkias. This transaction reflects the discipline which we've discussed with investors over the past several years.

And we ended the quarter with cash cash equivalents and marketable securities of 449.7 million.

For additional details on our Q2 financial forms, please refer to the earnings release we issued today.

Speaker #3: We're investing from a position of strength while maintaining the financial flexibility to continue executing on Xtendi and advancing our broader pipeline. The Alkias 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.

turning to guidance, we have updated our outlook for the remainder of 2026 and

Increased extending full year at product, sales, guidance to 685 to 705 million from our prior guidance.

Jeff Farrow: 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. We expect tempered growth in Q3. We then expect more robust growth in Q4, 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.

Of 670 to 700 million.

This increase reflects our confidence in the underlying strength of the business.

Speaker #3: 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.

As we have previously, discussed, we expect the quarterly Revenue progression throughout the remainder of the year to reflect the normal seasonality, the Eye Care Market.

The summer period typically includes fewer physician office visits due to vacations, holidays, and conferences.

and we expect CAMPR growth in the

Speaker #3: In person, 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 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.

Speaker #3: We look forward to updating you as the transaction progresses. With that, I'll turn the call back to Bobby.

Move to operating expenses. We continue to expect gross margins of approximately 93%.

And sgna expenses of 545 to 565 million.

Speaker #2: 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 Xtendi.

Speaker #2: 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.

Jeff Farrow: 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, 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 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 strategy we've pursued, which we've discussed with investors over the past several years.

We now expect 4 year R&D expense to be in the range of 190 million to 210 million dollars. An increase from a previous guidance of 115 million to 235 million increase, reflect The Upfront consideration of 75 million for the acquisition of ironic Medical.

Speaker #2: 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.

This guidance does not include any potential acquisition calculus.

Speaker #2: We're incredibly excited about the opportunity ahead. Operator, please open the line for questions.

Turning the financial terms of the alkes transaction, The Upfront consideration is 450 million consisting of 270 million in cash and 180 million dollars in tars common stock.

Speaker #4: Thank you. As a reminder, if you have a question, please press star 11 on your telephone and wait for your name to be announced.

Speaker #4: To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. And our first question comes from Graig Suvannajet.

Concludes up to 350 million dollars in potential must buy 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,

Speaker #4: Of Mizuho, your line is open.

Speaker #5: Hey, good morning. This is Brian Reeson today for Graig Suvannavej. Thanks for taking our question. I just wanted to ask a little bit about the new asset and how you see it comparing an efficacy to 10 Laraban, the Stargard medication in phase two trials for Blight, which has a head start.

In addition weed, 125 million through a private placement financing from a Syndicate of leading Healthcare investors including several shareholders of alias.

This transaction, reflects the discipline.

Jeff Farrow: 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 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.

Which we've discussed with investors over the past several years. We're investing from a position of strength.

Speaker #5: Is there any differentiating factor that you think could help deal with this to capture more market share relative to 10 Laraban? Thanks.

While maintaining the financial flexibility to continue executing and advancing our broader pipeline.

Speaker #2: Thank you, Brian. Yeah, this is Bobby. We're really excited about this asset. As mentioned, we really serve as a landscape and found, I think, a very compelling late-stage opportunity and we understand that we're likely going second here.

The Alps transaction is expected to close later this year, subject to expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and other customary closing conditions.

Speaker #2: 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 for patients, both the progression of disease is measured by atrophy and the progression of disease is measured by visual acuity.

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 age program with significant potential.

In person for the entire tars team, it represents a significant and potentially transformative opportunity to help patients.

Speaker #2: Low-light visual acuity in particular. And that's unique in this field. We also see a great safety profile with up to seven years of data over 400 patients treated.

Children and Adolescent maintain Vision longer by slowing the progression of this blinding disease.

We look forward to updating you as the transaction progresses.

That alter the call back to Bobby.

Bobak Azamian: 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 eyecare, 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, it strengthens our retina portfolio and reinforces our mission 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.

Bobby Azamian: 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 eyecare, 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, it strengthens our retina portfolio and reinforces our mission 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.

Speaker #2: 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.

Hey Jeff. Before we open the line this morning, let me leave you with one final thought.

everything we've talked about today, starts with stemi

Speaker #2: And we can certainly dig deeper here over the course of the call.

Speaker #6: Thank you, Bobby. And thanks for the question, Graig. As I mentioned in the prepared remarks, to build a retina 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.

Its success has changed the standard of care. Is 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.

Speaker #6: And that's a very key indicating factor for us with this particular molecule. And this particular mechanism. Toxic dimers are the key cause of retinal death.

Strengthens our retina portfolio and reinforces our mission to build 1 of the most Innovative and differentiated companies. And I care.

We're incredibly excited about the opportunity ahead.

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 Graig Suvannavejh of Mizuho. Your line is open.

Operator. Please open the line for questions.

Thank you.

Speaker #6: And we also want to make sure that the vitamin A visual participation in the visual cycle is not curtailed. And that's precisely what this medicine does.

Speaker #6: And it's actually shown in the data that we don't see any night vision adaptation or color disturbances. And a very, very good safety and tolerable profile.

As a reminder, if you have a question, please press star, 1, 1 on your telephone and wait for your name to be announced to withdraw your question. Please, press star 1 1, again please, stand by while we compile the Q&A roster.

And our first question comes from Greg Savannajet of Mizuho. Your line is open.

Ryan Rison: Hey, good morning. This is Ryan Rison 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 III trials for Belite Bio, which has a headstart. Is there any differentiating factor that you think could help gildeuretinol to capture more market share relative to tinlarebant? Thanks.

Speaker #6: So we think this medicine will differentiate itself on those properties. And it's very important for the patient, especially in a binding disease, to not impact the visual side.

Speaker #5: And Ryan, maybe I'll add this as Jeff. Just we did some market research on what Sesha just highlighted there, showing structural benefits, functional benefit with LLVA, and just a really nice safety profile.

Hey, good morning. This is Ryan Rhian today, for Greg Spotify. Thank you for taking our question. Um, just wanted to ask a little bit about the new asset and how you see it comparing an efficiency to 10 Lahr about the the stargardt medication in Phase. 2 trials for bite, which has a head start, is there any differentiating factor that you think could help deal with it to capture more market? Share a relatively similar event. Thanks

Bobak Azamian: 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 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.

Bobby Azamian: 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 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.

Speaker #5: And we surveyed about 100 retinal docs. And based on that, we really think that this is a billion-dollar-plus opportunity based on that micro by that differentiation there.

Speaker #5: Great. All right. Thanks, guys.

Speaker #4: Thank you. And our next question comes from Eddie Hickman of Guggenheim Securities. Your line is open.

Speaker #7: Hey, guys. Good morning. And thanks for the question. And congrats on all the progress and the deals. So 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?

Thank you, Ryan. Yeah, this is Bobby. We're really excited about this asset. We really serve in the landscape and found, I think a very calling late stage opportunity and, um, we understand, um, that we're likely going second here and, um, you know, we're still very compelled by this. Um, so in terms of overall profile, um, we see something that can really change the course of this disease. That, um, the demonstrated, um, Effectiveness, um, in a couple of Dimensions is a really important.

Patients, both the progression of disease is measured by atrophy and...

Speaker #7: Appreciate it.

Speaker #2: Thank you. Yeah, Eddie, I'll start, and I'll pass to our commercial officer, Neera. So it's a great point. We're entering a new field, retina.

Bobak Azamian: 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 with the rest of the call.

Bobby Azamian: 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 with the rest of the call.

Speaker #2: We're really excited to have now two phase three drugs. I'd kind of go back to six years ago when we were at that same stage with Xtendi and we took a very diligent approach to understanding the eye care provider and really educating them.

Sesha Neervannan: 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, and 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 differences. A very good safety and tolerability profile. 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 cycle.

Um, the progression of these measured by um visual Acuity low, light visual Acuity in particular. And that's that's um, unique in this field. We also see a great safety profile with um, up to 7 years of data over 400 patients treated. Um, so we think that presents compelling opportunity. Um, I'll pass, um, to our top ring officer Tisa to talk a little bit more about that profile. And, um, you know, we can certainly dig deeper here over the course of the call.

Speaker #2: And I know we'll do that here as well. So we have two drugs in phase three. One, IRX 101's a little bit ahead of ALK 001.

Speaker #2: So I think it positions us well. And I'll pass to Neera to talk about some of this energy.

Speaker #7: 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.

Speaker #7: And it plays exactly to what we've been doing with Xtendi. And here are a couple of reasons why. Because we're still with a high unmet need.

Speaker #7: We'll plan to deliver evidence to differentiate the science. And what's different here in terms of the call points is we're talking about a more concentrated physician-based base.

Speaker #7: About 3.5,000 of these physicians out there today. And our focus will be on securing broad access and launching efficiently into a concentrated physician audience.

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 100 retinal docs, and based on that, we really think that this is a billion-dollar-plus opportunity based on that micro by that differentiation there.

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 in the data that we don't see any um uh night uh Vision adaptation or color, uh uh you know, disturbances um and and a very very uh good safety profile, safety and possible profile. So we think this medicine will differentiate itself on those properties and it's very important for the patients, especially in a meeting disease, will not impact the visual side.

Speaker #7: So it's a different playbook from the DB, but very similar footprint. And as you know, we've proven that we can execute and we're really excited about this opportunity.

And right, maybe I'll let this is Jeff. Just read some market research on the what you say should just highlighted there, you know, starting structural benefit.

Speaker #2: And the other thing I'd point out is there's a lot of there's a lot of overlap in the calling here. So it's about 3,500 doctors we'll be serving with IRX 101 that are doing IUDs and then a subset of those actually 2,000 are prescribing what we think are likely to prescribe over 80% of the targets.

Functional benefit with lva and just a, a really nice safety profile and we surveyed about a 100 reps and based on that, we really think this is a a billion dollar plus opportunity based on that Micro by that differentiation there.

Ryan Rison: Great. All right. Thanks, guys.

Operator: Thank you. Our next question comes from Eddie Hickman of Guggenheim Securities. Your line is open.

Great. All right. Thanks guys.

Speaker #2: Therapies here. So that presents some real synergy in terms of the sales force itself that we'll be building here.

Thank you.

Speaker #7: Got it. And in terms of access, is that the same timeline as Xtendi in terms of sort of getting payer reimbursement set up? So we think about it the same as Xtendi, or is it different for this space?

Eddie Hickman: Hey, guys. Good morning, thanks for the question, and 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.

And our next question comes from Eddie Hickman of Guggenheim Securities. Your line is open.

Speaker #7: 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.

Speaker #2: The other thing I'll have Liz Yeu, our CMO, talk about. We're in front of the eye company, and this is often where patients with startups present.

Bobak Azamian: Thank you. Yeah, Eddie, I'll start and 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 two phase III drugs. I'd kind of go back to six 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. I know we'll do that here as well. We have two drugs in phase III, one IRX-101's a little bit ahead, ALK-001, I think it positions us well and I'll pass to Neera to talk about some of the synergy pieces.

Bobby Azamian: Thank you. Yeah, Eddie, I'll start and 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 two phase III drugs. I'd kind of go back to six 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. I know we'll do that here as well. We have two drugs in phase III, one IRX-101's a little bit ahead, ALK-001, I think it positions us well and I'll pass to Neera to talk about some of the synergy pieces.

Hey guys. Good morning and thanks to the question and congrats on all the progress and the deals. So now that you're building towards 2, retinol, launches sort of on different timelines. Can you talk about, you know, uh, 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 um in terms of size and and and scope appreciate it.

Speaker #2: So Liz, you might speak to your experience and how you see kind of the initial assessment in the eye care provider landscape here.

Speaker #7: 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.

Speaker #7: And 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's disease is that almost half the patient population are actually kids and adolescents.

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. It plays exactly to what we've been doing with XDEMVY. Here are a couple of reasons why. 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 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.

Speaker #7: And of those who are the fastest progressors, half of them actually go blind within seven years. So 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 eye care physicians who are seeing them because of those complaints, failed vision tests, or because they're coming in for glasses.

Thank you. Um yeah. Do y'all start, and I'll pass to our commercial officer NRA. Um, so it's a great point, we're entering a new field retina. Um, we're really excited to have now 2, phase 3, drugs. Um, I I kind of go back to, you know, um, 6 years ago when we were, at that same stage with xmv. And, you know, we took a very diligent approach to understanding, um, the eye care provider and really educating. And I know we'll do that here as well. So, um, you know, we have, um, 2 drugs in faith, Street 1 irx 101, um, a little bit ahead, um, you know, okay. 000001. So I think it positions us, well, and I'll pass the nearest talk about some of this energy CC

Lobby.

Uh, we believe both of these.

Assets are a great commercial.

For Tarsus.

Build the the pipeline to become that broad Eye Care leader.

And it plays exactly to what we've been doing with the dumbing. And here are a couple of reasons why? Because we're still service servicing and underserved population with a high unmet need. We'll plan to deliver evidence to differentiate the science.

Speaker #7: It will be then diagnosed by the retina specialist, but it will be a shared opportunity. So there is that, yes, we have the blueprint of the education and the evidence generation.

And what's different here in terms of the call points is we're talking about a more concentrated position based.

Speaker #7: But the retina doctors, it is a small subset that we will definitely extend leverage the relationships, educate, and certainly generate the evidence. Great. Thank you so much for that color.

Bobak Azamian: The other thing I'd point out.

Bobby Azamian: The other thing I'd point out.

About 3.5 thousand of these Physicians out there today and our Focus will be on securing broad access and launching efficiently into a concentrated position audience. So it's a different Playbook from the TV but very similar uh footprint and as you know, we've proven that we can execute, we're really excited about this opportunity.

Neera Clase: Just one follow up.

Bobak Azamian: Is there's a lot of overlap in the calling here. About 3,500 doctors we'll be serving with IRX-101 that are doing IVTs, 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.

Bobby Azamian: Is there's a lot of overlap in the calling here. About 3,500 doctors we'll be serving with IRX-101 that are doing IVTs, 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.

Speaker #4: Thank you. And our next question comes from Jason Gerberry of Bank of America. Your line is open.

Speaker #6: 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-some thousand patients; B, lights talked about a pricing in the $350 to $500K territory.

Eddie Hickman: Got it. In terms of access, is that the same timeline 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?

And the other thing I'd point out is um there's a lot of um there's a lot of overlaps in the calling here. So it's about 3,500 doctors will be serving with rx11 um that are doing ibts. And then a subset of those actually 2,000 are prescribing. We think we're likely to prescribe over 80% of the star guards, um, therapies here. So that, that presents some real Synergy. In terms of the sales force itself that we'll be building here.

Speaker #6: So trying to get a sense of what proportion of these patients are actually under the care of a retinal specialist and is it addressable sort of market?

Neera Clase: Different in that it's rare, very similar in terms of how we've gone about access, right? A differentiated value story, very comparable in terms of fast access, broad access.

Got it. And in terms of access, is that the same timeline as XMV in terms of sort of getting payer reimbursement set up? So, do we think about it the same as XMI, or is it different for this space?

Speaker #6: Secondly, just a question around how to think about sort of the use of natural history. So 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.

Bobak Azamian: The other thing-

Bobby Azamian: The other thing-

Eddie Hickman: Thank you

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

Bobak Azamian: I'll have Elizabeth 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 the initial assessment in the eye care provider landscape there.

Bobby Azamian: I'll have Elizabeth 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 the initial assessment in the eye care provider landscape there.

Speaker #6: So just wondering how you think about the need for longer-term follow-up and sort of the durable BCVA benefit. Thanks.

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. 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.

Speaker #7: 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.

Speaker #7: Around that $350K price point. And it's really about value creation, right, 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.

Elizabeth Yeu: 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, the retina doctors, it is a small subset that we will definitely extend, leverage the relationships, educate, and certainly generate evidence.

The other thing I I'll have Liz Liz. You our CMO talk about know, we're in front of the eye company and this is often where the patients with startups present. So you might speak to your experience. And how you see kind of the initial, um, assessment. When the I can provide thank you Bobby. Um, when we think about the patients that we're taking care of, certainly I'm taking, um, a view of it from the patient perspective. And while most of the diseases that we see, as I care providers, see they worsened aging? What's so unique? And so, um, humbling about star guards is the 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.

Speaker #7: So we're excited to launch in this. And 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.

Speaker #7: With that, I'll turn it over to Sesha to provide additional comments.

Speaker #2: Yeah. Thank you, Neera. So 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 a even more of a sensitive measure than a BCVA, was statistically significant.

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 eye care physicians who are seeing them because of those complaints, failed vision tests, or because they're coming in for glasses.

Speaker #2: We saw a benefit within two years. In those trials. And that is a great measure to follow up because low-light visual acuity is a precursor of BCVA tends to worsen slower.

It will be then diagnosed by the retina specialist, but it will be a shared opportunity. So there is that. Yes, we have the blueprint of um, the education and the evidence generation, but the retina doctors, it is a small subset that we will definitely um 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.

Great, thank you so much for that color.

Thank you.

Speaker #2: And LLVA. And so that's a great measure for the physicians to monitor and look at the progress of the vision loss. So the tools are there, and they are very measurable.

Jason Gerberry: Hey, guys. Thanks for taking my questions. I'm trying to think about, A, the market opportunity here. I think you said something like 30,000 patients. Belite Bio's talked about a pricing in the $350,000 to $500,000 territory. Trying to get a sense of what proportion of these patients are actually under the care of a retinal specialist, and is it an 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 1 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.

Jason Gerberry: Hey, guys. Thanks for taking my questions. I'm trying to think about, A, the market opportunity here. I think you said something like 30,000 patients. Belite Bio's talked about a pricing in the $350,000 to $500,000 territory. Trying to get a sense of what proportion of these patients are actually under the care of a retinal specialist, and is it an addressable sort of market? Secondly, just 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. Just wondering how you think about the need for longer-term follow-up and sort of the durable BCVA benefit. Thanks.

And our next question comes from Jason Gerber of Bank of America. Your line is open.

Hey guys. Um thanks for taking my questions. Um I'm just trying to think about just a the market opportunity here. I think you said something like 30, something thousand patients.

Speaker #6: Hello?

Speaker #4: Our next question comes from Lachlan Hanbury-Brown. William Blair, one moment.

Be like talked about, uh, a pricing, uh, in the 350 to 500k territory. So, trying to get a sense of What proportion of these patients are actually under the care of like a retinal specialist and and and and is an addressable sort of Market. Um secondly just a question around how to think about like sort of the use of Natural History

Speaker #6: Yeah. Hi. I was just wondering if the team is there. I think they cut out on that last question.

Speaker #2: We're here. No, we're here.

Speaker #6: Okay. All right. Great. Yeah. Thanks for the questions. Congrats on the deal, I guess. Maybe a couple of quick ones. Just first, you've been talking a lot about the Stargardt program.

So like on bcva changes over say a 2 year period versus lesion growth. I think um the competitor had flagged, you know, 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 bcba benefits. 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 $350,000 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, and 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.

Speaker #6: With guilded retinol, but I know that Alkius was at least until recently. I'm not sure if it's still going, but looking at geographic atrophy.

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.

Speaker #6: So wondering if you're thinking there's an opportunity there, if you've described any value to that, or if this is really just about Stargardt. And then maybe a second question.

Speaker #6: You said you're thinking about a potential second phase three for approval. I just wanted to clarify. Are you expecting a second phase three 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?

Around that 350, K price point. Uh, and it's really about value creation, right? Uh, understanding the differentiated profile here. And as we think about this particular asset,

Speaker #2: Yeah. Thank you, Lachlan. I'll take the first part of that and Sesha. We'll take the second part. So we really looked at this in terms of the acquisition as focused on Stargardt.

there is a safety and tolerability value proposition that really resonates here and differentiates from the competition. So we're excited to launch in this. And 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.

Sesha Neervannan: 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 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. 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.

Sesha Neervannan: 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.

With that, I'll turn it over to Stacey to provide additional funds.

Speaker #2: We see that there's been a corner of patients treated, including GA study. 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.

Speaker #2: And Sesha will ask you.

Speaker #3: Thank you, Bobby. Yeah. As I mentioned, our current phase three trial, North Star, is a very robustly designed trial. And in patients in a large set of patients, in fact, it's potentially the largest progressive prospective trial that has been conducted in Stargardt disease.

Speaker #3: And it's powered very conservatively and very robustly for meeting both the primary and secondary endpoints. So we are very confident about this trial. Providing a very robust clinical package along with the very strong phase two data as well.

Jason Gerberry: Hello?

Yeah, thank you. Nah. Um, so with respect to your question on a long-term, follow-up on the vision benefit, uh, what we saw in the trials is that, um, the, the, uh, worsening of low light visual equity, which is actually a, uh, even more of a sensitive measure than a bcva. Um, was was strictly significant, we saw the benefit with 2 years, uh, in those trials. And, and that is a great measure to follow up because, uh, low light visual Equity is, is a precursor of pcva loss dcva tends to, um, worsen slower and lnva. And so, that's a, that's a great measure for the Physicians to, um, Monitor and and, and uh, you know, look at the process of division vision loss. So, uh, the the tools are there and, um, they are very much.

Speaker #3: 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 medication if we need it.

Operator: Our next question comes from Lachlan Hanbury-Brown of William Blair. One moment.

Our next question comes from Lachlan Hanbury Brown. William, Blair 1 moment

Speaker #3: And also, any potential upside where we could enhance the data and enhance the exercise with the progresses or other ways to enhance it. So it's really more of a risk mitigation and potential upside strategy.

Lachlan Hanbury-Brown: Yeah. Hey. I'm just wondering if the team is there. I think they cut out on that last question.

uh,

Bobak Azamian: We're here. No, we're here.

Bobby Azamian: We're here. No, we're here.

Yeah. Hey, um, just wondering—is the team there? I think they cut out on that last question.

Lachlan Hanbury-Brown: Yep. Okay, great. Yeah, thanks for the questions. Congrats on the deal, I guess. Maybe a couple quick ones. First, you've been talking a lot about the Stargardt program with gildeuretinol, I know that Alkeus was, at least until recently, I'm not sure if it's still going, 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 Stargardt? 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 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.

Speaker #3: And we still need to talk to the FDA about how that study may look like. So stay tuned for how that progresses.

We're here. No, we're here. Yep, all right, great. Um, yeah. Thanks for the questions. Uh, congrats on the deal, I guess.

Maybe a couple quick ones just first. You've been talking a lot about the Stargardt program.

Speaker #4: Thank you.

Speaker #6: Thanks.

Speaker #4: And our next question comes from Mazi. I'll let me know how much of Oppenheimer your line is open.

Speaker #6: Thank you. Thanks, Bobby, and thank you for taking the question. So yeah, I think one from us is that I think when we were looking, so it sounds like Alkius has previously mentioned that the cleanest signal in Stargardt came from the presymptomatic and early-stage patients.

With skills right now. But I know that alkis was, uh, at least until recently, I'm not sure if it's still going, but looking at Geographic. Atrophy so wondering if if you're thinking there's an opportunity there if you describe any value to that or if this is really just about and then

Speaker #6: But we noticed that North Star is enrolling advanced disease. So how do we square the pivotal population with the mechanism? Is the expectation just that a slower atrophy, excuse me, front at the lesion margin?

Is that a different data set, or a different layer of data, different population, that kind of thing?

Bobak Azamian: Yeah. 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 quarter of patients treated, including the GA study, 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, I'll pass it on to you.

Bobby Azamian: Yeah. 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 quarter of patients treated, including the GA study, 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, I'll pass it on to you.

Yeah, thank you. And I'll take the first part of that initial. We'll take the second part.

Speaker #6: And I guess a second follow-up to that is that if that's the case, then what reduction there do you consider clinically meaningful?

Speaker #3: Yeah. Thank you. Thank you, Nazia. For the question. So the North Star trial is designed for advanced patients, but also includes younger and progressive patients.

Speaker #3: As I mentioned, it's includes patients from age of 8 to 45. And so we really capturing those patients in the disease state. The specific lesion for a growth of atrophic lesion, which is a very well-known and precedented endpoint by the FDA for approval.

Sesha Neervannan: Thank you, Bobby. As I mentioned, our current phase III trial, NORTHSTAR, is a very robustly designed trial in a large set of patients. In fact, it is potentially the largest progressive prospective trial that is being conducted in Stargardt disease. It is 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. 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 FSIS with the path progressors or other ways to enhance it.

Um so we really looked at this um in terms of the acquisition as far as stargard. Um you know we we see that there's been a 400 patients treated including the ga and that provides really strong Foundation. Um so while we're acquiring the entire company, our um, our focus is really on Star guards in terms of the the value ascribed here. And um, essentially

Speaker #3: And that's how it is designed. And the tease data showed that there's a very robust reduction of that atrophic lesions in the trials. We saw about 29% reduction compared to placebo.

Speaker #3: So I think there's a study is designed to hit on the primary endpoints that and secondary endpoint of visual equity that is precedented with the FDA.

Speaker #3: And really, it's positioned to win on those endpoints.

Thank you, Bob. Yeah, you know, as I mentioned, uh, our current phase 3 trial not star. Um, is a very costly designed file, uh, and, and um, in patients, in, in a, in a lot of set of patients. In fact, it's, uh, potentially the, uh, the largest Progressive, uh, uh, uh, prospective trial that I've been conducted in stronger disease. And it's powered very, um, very conservatively and very, uh, the robustly, uh, for, uh, meeting both the primary and secondary endpoints. And so, we are very confident about this trials, uh, providing a very robust, clinical package along with the very strong Phase 2 Data as well. So that is our primary approach. Um, and we are very confident that it will, it will be a very compelling evidence for registration and approval.

Speaker #2: And I'll just add, when we looked at the data package here, we saw really good signals throughout multiple phase two studies. In both moderate disease, advanced disease, and in some early patients.

Speaker #2: So we got confident across the spectrum of disease that Sesha is describing here in North Star.

Sesha Neervannan: It is 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.

Speaker #6: Got it. Thank you. And then I guess with that, so if Ken Laravent is approved, could that affect trial enrollment going forward?

The way we think about the second trial is is really you know, proactively thinking about um any of this medication if we need it and also any potential upside where we could enhance the data, enhance, the exercise, um, with the with the progressives or other uh, other ways to enhance it. So it's really more of a risk mitigation and potential upside strategy. And and we still need to talk to the FBA about, uh, about how that study may look like. So, uh, so stay tuned for for how that progresses.

Speaker #3: We don't think so. The trial, the North Star trial is being conducted globally at many sites. And the trial is already enrolling. We started the trial two months ago.

Lachlan Hanbury-Brown: Thanks.

Operator: Thank you. Our next question comes from Mazahir Alimohamed of Oppenheimer. Your line is open.

Operator: Thank you. Our next question comes from Mazi Alimohamed of Oppenheimer. Your line is open.

Thank you.

And our next question comes from Maisie Alamo hmed of Oppenheimer. Your line is open.

Mazahir Alimohamed: Thank you. Thanks, Bobby, and thanks for taking the question. I think one for Muz is that I think when we were looking, it sounds like Alkeus has previously mentioned that the cleanest signal in Stargardt 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 that a slower atrophy front at the lesion margin? I guess the second follow-up to that is, if that is the case, what reduction there do you consider clinically meaningful?

Mazi Alimohamed: Thank you. Thanks, Bobby, and thanks for taking the question. I think one for Muz is that I think when we were looking, it sounds like Alkeus has previously mentioned that the cleanest signal in Stargardt 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 that a slower atrophy front at the lesion margin? I guess the second follow-up to that is, if that is the case, what reduction there do you consider clinically meaningful?

Speaker #3: Alkius started the trial two 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 on the way in terms of our enrollment.

Speaker #3: And also, as I mentioned, we have many non-receiver sites that we can also leverage even down that.

Speaker #6: got it. Okay. Thank you for taking our questions.

Speaker #4: Thank you. And our next question comes from Francois Brisebois of Lifesci Capital. Your line is open.

Thank you. Thanks uh Bobby and thank you for taking a question. So yeah. I think 1 from us is that I think when we were looking to see, it sounds like alcus has previously mentioned that the cleanest signal in Starbucks, 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 that a slower? Atrophy atrophy, excuse me front at the legion margin and um, I guess the second thought to that, is that if that's the case, then what reduction there do you consider cleaning quickly meaningful.

Sesha Neervannan: 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 in a group of atrophic lesions, 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 trial. We saw about 29% reduction compared to placebo. I think the study is designed to hit on the primary endpoints that and secondary endpoint of light visual acuity that is precedented with the FDA. Really it's positioned to win on those endpoints.

Speaker #6: Hi. Thanks for taking our questions. This is Dan on for Frank. Congrats on all the progress. I guess firstly on the extent we treatment rates reaching high teens, could you give us some color on what you're seeing in terms of extending durability of treatment response and physician retreatment behavior as you think about, I believe you've previously mentioned, that rate kind of stabilizing around 20% and your confidence there?

Yeah, thank you. Thank you Nazi, uh, for the question. Um, so the the nausea trial uh, is designed um, for advanced patient but also uh, include younger and Progressive patients as I mentioned. Uh, it's a, you know, it includes patients from age of 8 to 45. And so, we really, um, capturing those patients in the, in the disease State. Um,

The.

Speaker #6: 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, it to sort of treated patients?

Lesions or, you know, growth of atrophic lesion which is, um, which is very well known and, you know, precedented income by the FDA for, for approval and and that's how it is. It is designed. Um, and the team's data showed that, um, there's a, um, a very robust, uh, you know, um, uh,

Speaker #6: Thank you.

Speaker #4: 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% state.

Speaker #4: 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.

Bobak Azamian: 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 Sesha is describing here in NORTHSTAR.

Bobby Azamian: 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 Sesha is describing here in NORTHSTAR.

Reduction of that atrophic lesions in in the trials. We know we saw about 20 29% reduction, um, compared to the sibo. So, um, I think, I think the study is designed to hit on the primary endpoints that and secondary endpoint of light visual, uh, Equity. Um, that is presented with the FDA and, uh, really. It's um, uh, it's positioned to to win on those end points.

Speaker #4: Patients who actually have good experience with extending to begin with come back when their symptoms recur. And this is still very much a new prescription story, as it relates to retreatment.

Mazahir Alimohamed: Got it. Thank you. I guess with that, if tinlarebant is approved, could that affect trial enrollment going forward?

Mazi Alimohamed: Got it. Thank you. I guess with that, if tinlarebant is approved, could that affect trial enrollment going forward?

And I'll just add. Um, when we looked at the data package, here we saw, you know, really good, um, signals throughout, multiple Phase 2 studies, um, in both modern disease, Advanced disease, and in some early patients. So, you know, we we got confident across the spectrum of disease that says describing here in Northstar.

Speaker #4: The second part of your story was around or your question was around the DC. And our concern engine is really performing ahead of our own expectations.

Um guys, thank you and then I guess with that. So if can uh, can Lara bent is approved, how could that affect trial enrollment going forward?

Sesha Neervannan: We don't think so. 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 down that.

Sesha Neervannan: We don't think so. The NORTHSTAR trial is being conducted globally at many sites, and 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-US sites that we can also leverage even down that.

Speaker #4: What we've seen is increasing awareness through branded, unbranded, and our celebrity campaign with Cina. The unaided awareness is now up to 30%. And if you think about it, we're restarted.

Speaker #4: We're at 2%. Now, one in every three patients can recognize extending by name. So that's really quite exceptional velocity for a disease that most people really never heard of.

Speaker #4: And our website engagement is also up by the 30%. And patients are, as we mentioned, asking for extending by name. On spend, you could think about it as it being very efficient and very disciplined.

Mazahir Alimohamed: Got it. Okay. Thank you for taking our questions.

We can also leverage even on that.

Mazi Alimohamed: Got it. Okay. Thank you for taking our questions.

Ah got it. Okay. Uh thank you for taking our questions.

Operator: Thank you. Our next question comes from François Brisebois of LifeSci Capital. Your line is open.

Thank you.

Speaker #4: And the returns continue to support the continued investment.

And our next question comes from Francois, Bruce Spa of Life side, Capital. Your line is open.

[Analyst] (LifeSci Capital): 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 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 into treated patients? Thank you.

Speaker #6: Thank you.

Speaker #4: Thank you. And our next question comes from Matthew Caufield of HC Wainwright. Your line is open.

Speaker #6: Hi. Good morning, guys. I'm really great to see the range of updates this morning. So 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?

Speaker #6: And then separately, regarding the Alkios acquisition, what milestones would define success over the next 12 to 24 months considering the phase three North Star top line are expected later into second half '29?

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 teen, and we see it stabilizing at about a 20% steady-state. The why really matters here when we think about retreatment. Demodex blepharitis is a recurring condition, and only ECPs 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%.

Hi, thanks for taking our questions. This is Dan on for Frank. Um, congrats on all the progress. Uh, I guess, firstly on the extent we we treatment rates, um, reaching High Teens. Could you give us some color on what you're seeing? Um, in terms of next mb's, durability of treatment response and physician retreatment behavior. Um, as you think about, uh, I believe you have previously mentioned that rate kind of stabilized around 20%, um, and your confidence there. Um, and secondly, uh, in terms of the dgc efforts, um, could you give us some color on how that kind of uh um, in terms of website engagement? What that conversion rate is? Uh, it to sort of treated patients. Thank you.

Speaker #6: Just in terms of judging whether the acquisition is tracking kind of above or below your near-term expectations. Thanks a lot.

Sure, in terms of retreatment, it's maturing just as we've described in the past.

Speaker #5: Good morning, Matt. This is Jeff. Happy to answer those questions. So no pipeline shift. We have a robust balance sheet that will continue to allow us to focus on the existing pipeline.

Uh, it continues to advance into the high teens and we see it stabilizing at about 20%.

Speaker #5: We're really excited about the ocular rosacea program. You highlighted the Lyme, which our baseline assumption is department. With the phase three ready package, but also the Irenics product is something that we're really excited about getting into the market here in the next couple of three years.

The, the why really matters here when we think about retreatment. Uh, DB is a recurring condition and only, uh, ecps can make that decision to retreat.

Speaker #5: So we're fully committed to the pipeline, including the Alkios phase three study. So and then on sort of the data flow on the Alkios one, in essence, one of the things will obviously be tracking is with patient enrollment.

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.

Uh, the second part of your story was around or your question was around the DC.

And our consumer engine is really performing ahead of our own expectations.

Speaker #5: And so that'll be something key there is a design within the study that will allow for an intra-analysis that is something that we are going to be discussing internally and see if that makes sense to do, but that is a potential option for us to do.

Neera Clase: If you think about it, where we started, we were at 2%. Now 1 in every 3 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.

Neera Clase: 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.

Speaker #5: And then, of course, there'll be the data top line data, which we expect to be sometime in the second half of 2029.

What we've seen is, increasing awareness, through branded unbranded and our celebrity campaign with Cena, the un, uh, aided awareness is now up to 30%. And if you think about it, where we started, we're at 2% uh Now 1 in every 3 patients can recognize extended by name. So that's really quite exceptional velocity for a disease that most people really never heard of

Speaker #6: Excellent. Thank you, guys. Really exciting to see all the updates.

Speaker #5: Thank you.

Speaker #4: Thank you. And our next question comes from Anthea Lee of Jeffries. Your line is open.

And our website engagement is also up uh by the 30% and patience. Uh as we mentioned, you know, asking for extended by name on spend you could think about it as it being very patient and very disciplined and the returns continue to support the continued investment.

[Analyst] (LifeSci Capital): Thank you.

Thank you.

Operator: Thank you. Our next question comes from Matthew Caufield of H.C. Wainwright. Your line is open.

Speaker #7: Hi. This is Anthea on for Dennis. Thank you for taking our questions. Just two questions from us. On the extending guidance, the implied script trajectory looks fairly conservative, even accounting for holidays and seasonality.

Thank you.

Matthew Caufield: Hi, 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 to 24 months, considering the phase III NORTHSTAR top line are expected later into H2 2029? Just in terms of judging whether the acquisition is tracking above or below your near-term expectations. Thanks a lot.

And our next question comes from Matthew cfield of HC Wang, right? You're lying is open.

Speaker #7: Is there anything we're missing in terms of script acceleration in second half outside of seasonality? And then secondly, how are you thinking about profitability now that you R&D spend for these two new assets and then also expand the sales force?

Speaker #7: I think consensus has Tarsus becoming EBIT positive in 2027. Do you still think that's fair? Thank you.

Speaker #5: 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.

Speaker #5: 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.

Hi, good morning, guys. I'm really great to see the range of Updates this morning. Um, so 2 questions from us with the evolving pipeline. Now, with data Catalyst, the coming years, is there any shift to the prioritization programs other than the partnership potential for Lyme disease? And then separately regarding the alka's 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 29, just in terms of judging, whether the acquisition is tracking kind of above or below your near-term expectations.

Thanks a lot.

Jeff Farrow: 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'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. Also the IRX-101 product is something that we're really excited about getting into the market here in the next couple, three years. We're fully committed to the pipeline, including the Alkeus phase III study. On the data flow on the Alkeus, the ALK-001. In that sense, one of the things we'll obviously be tracking is the patient enrollment. That'll be something key. There is a design within the study that would allow for an interim analysis.

Speaker #5: 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.

Speaker #5: Even with the incremental spend on Irenics, and the Alkios, and the timeframe of when those data will turn over, we shift our ability to go profitable, maybe perhaps by a quarter or two.

Good morning, Matt. This is Jeff happy to answer those questions. So, no pipeline shift. I we're you have to, you know, robust balance that will continue to allow us to focus on the existing pipeline. Uh, you know, we're really excited about the ocular rosacea program. You highlighted the line, which our Baseline assumption is is to partner with the face. You ready package? Uh, but also, the iranx product is something that we're, uh, really excited about getting into the market here in the next couple of 3 years. Uh, so we're fully committed to the pipeline including the uh, the alcaeus uh phase 3 study.

Speaker #4: 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 could think about a different sales force of between 50 to 75 complete teams.

Jeff Farrow: That is something that we are going to be discussing internally and see if it makes sense to do, that is a potential option for us to do. Of course, there'll be the top-line data, which we expect to be sometime in the H2 2029.

Speaker #7: Okay. Great. Thank you so much.

The second half of 2029.

Matthew Caufield: Excellent. Thank you, guys. Really exciting to see all the updates.

Jeff Farrow: Thank you.

Excellent. Thank you guys. Really exciting to see all the the updates.

Operator: Thank you. Our next question comes from Anthea Li of Jefferies. Your line is open.

Thank you. Thank you.

Anthea Li: 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 H2 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 EBIT positive in 2027. Do you still think that's fair? Thank you.

And our next question comes from Anthea, Lee of Jeffrey's. Your line is open.

Hi, this is Anthea on for Dennis. Thank you for taking our questions. Um, just 2 questions from us on the extend, be Guidance. The implied script trajectory looks fairly conservative even accounting for holidays and seasonality, is there anything we're missing in terms of acceleration in the second half outside of seasonality. Um, 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 um Tarsus becoming epic positive in 27. Do you still think that's fair? Thank you.

Jeff Farrow: 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 Agios risk in the timeframe of when those data will turn over, shift our ability to go profitable maybe perhaps by a quarter or two.

So happy to take that question. No, we, we believe the guidance that we gave is uh, appropriate guidance based on, you know what, our we've historically seen in terms of seasonality, uh, and the expectations for various meetings and holidays. So, so we stand by that guidance. Of course, we always have an opportunity to update that in subsequent quarters, but right now we're we're pleased. How we move that up. I think it shows 1 Los growth uh on the profitability. We haven't commented on profitability yet. Uh that said if you take a look

The guidance that we have provided take the top end of the revenue and the, you know, the bottom end of the Opex, uh, you could see it's going profitable sometime in in 27. Uh, even with the incremental spend on Irene and the Alka in the time frame of when those data, uh, turnover

shift our ability to go profitable, maybe perhaps by a quarter or 2

Neera Clase: The last part of that question was the sales force piece. 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.

And then, the last part of that question was the sales force piece and, uh, I'll take that in terms of as we think about Salesforce with the new assets. You could think about uh, a a different sales force of between 50 to 75. Uh, complete teams.

Anthea Li: Okay, great. Thank you so much.

Okay, 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.

this concludes our question and answer session, and today's conference call, thank you for participating and you may now disconnect

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