Q1 2026 Eton Pharmaceuticals Inc Earnings Call

May 14, 2026

Operator: Good afternoon, and welcome to the Eton Pharmaceuticals Q1 2026 Financial Results Conference Call. At this time, all participants are in listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn it over to David Krempa, Chief Business Officer at Eton Pharmaceuticals. Please proceed.

Speaker #1: Please revise that this call is being recorded at the company's request. At this time, I'd like to turn it over to David Krempa, Chief Business Officer at EN Pharmaceuticals.

Speaker #1: Please proceed.

Speaker #2: Thank you, Operator. Good afternoon, everyone, and welcome to Eaton's first quarter 2026 conference call. This afternoon, we issued a press release that outlines the topics we plan to discuss on today's call.

David Krempa: Thank you, operator. Good afternoon, everyone, welcome to Eton's Q1 2026 Conference Call. This afternoon, we issued a press release that outlines the topics we plan to discuss on today's call. The release is available on our website, etonpharma.com. Joining me on our call today we have Sean Brynjelsen, our CEO, James Gruber, our CFO, Judith Matthews, our Executive Vice President of Finance, and Ipek Erdogan-Trinkaus, our Chief Commercial Officer. In addition to taking live questions on today's call, we will also be answering questions that are emailed to us. Investors can send their questions to investorrelations@etonpharma.com. Before we begin, I would like to remind everyone that remarks made during the call may contain forward-looking statements that involve risks and uncertainties that could cause the actual results to differ materially from those contained in these forward-looking statements.

Speaker #2: The release is available on our website, etonpharma.com. Joining me on our call today, we have Sean Brynjelsen, our CEO; James Gruber, our CFO; Judy Matthews, our Executive Vice President of Finance; and Epic Trinkhaus, our Chief Commercial Officer.

Speaker #2: In addition to taking live questions on today's call, we will also be answering questions that are emailed to us. Investors can send their questions to investorrelations@etonpharma.com.

Speaker #2: Before we begin, I would like to remind everyone that remarks made during the call may contain forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those contained in these forward-looking statements.

Speaker #2: Please see the forward-looking statements' disclaimer in our earnings release and the risk factors in the company's filings with the SEC. Now, I will turn the call over to our CEO, Sean Brynjelsen.

David Krempa: Please see the forward-looking statements disclaimer in our earnings release and the risk factors in the company's filings with the SEC. Now, I will turn the call over to our CEO, Sean Brynjelsen.

Speaker #3: Thank you, David. Good afternoon, everyone, and thank you for joining us today. The first quarter was another great quarter for Eton. We achieved record product sales, delivering 73% year-over-year product revenue growth.

Sean Brynjelsen: Thank you, David. Good afternoon, everyone, and thank you for joining us today. The Q1 was another great quarter for Eton. We achieved record product sales, delivering 73% year-over-year product revenue growth. We launched two new major products, DESMODA and HEMANGEOL, and we made great strides advancing our R&D programs with the achievement of several development milestones. We will discuss all of these items and more on the call today. On the quarterly results, it was another great Q1 for Eton. With $24 million in product sales, an increase of 73% year-over-year, our growth continues to be driven by contributions across the product portfolio, including INCRELEX, ALKINDI SPRINKLE, Galzin, and carglumic acid, highlighting the diversification and durability of our rare disease portfolio.

Speaker #3: We launched two new major products, Desmota and Hemangiol, and we made great strides advancing our R&D programs with the achievement of several development milestones.

Speaker #3: We will discuss all of these items and more on the call today. On the quarterly results, it was another great quarter for Eaton, with 24 million in product sales and increase of 73% year-over-year; our growth continues to be driven by contributions across the product portfolio.

Speaker #3: Including Incrilex, Alkindi, Galzen, Anchor Glumic Acid. Highlighting the diversification and durability of our rare disease portfolio. This impressive revenue growth did not even include the benefit of the product launches of Desmota and Hemangiol since they launched in mid-March and May, respectively.

Sean Brynjelsen: This impressive revenue growth did not even include the benefit of the product launches of DESMODA and HEMANGEOL since they launched in mid-March and May, respectively. Based on the outperformance in Q1 and the trends we are seeing midway through Q2, I'm pleased to report that we are raising our full year revenue guidance. We now expect revenue to exceed $120 million, up from our previous guidance of $110 million. Importantly, we delivered this notable Q1 revenue growth in a highly profitable manner. We grew product revenue by 73%, but G&A spending increased by only 14% year over year on a GAAP basis and 22% on a non-GAAP basis.

Speaker #3: Based on the outperformance in the first quarter, and the trends we are seeing midway through the second quarter, I'm pleased to report that we are raising our full-year revenue guidance.

Speaker #3: We now expect revenue to exceed $120 million up from our previous guidance of $110 million. Importantly, we delivered this notable first quarter revenue growth in a highly profitable manner.

Speaker #3: We grew product revenue by 73%, but G&A spending increased by only 14% year-over-year on a gap basis and 22% on a non-gap basis. The majority of the G&A increase was due to increased costs of FDA annual program fees now that we no longer qualify for the Orphan Kadufa exemption.

Sean Brynjelsen: The majority of the G&A increase was due to increased costs of FDA annual program fees now that we no longer qualify for the Orphan PDUFA exemption rather than the true increases in our discretionary spend. Adjusted EBITDA for the quarter was $5.7 million or 24% of revenue. We continue to expect to achieve a greater than 30% adjusted EBITDA margin for the full year and believe we are on track to reach our goal of a 50% adjusted EBITDA margin by 2028. The results are a testament to the effectiveness and scalability of our unique rare disease model and infrastructure. Our nimble, proven infrastructure has allowed us to launch two new products in 2026 so far without a significant increase in expenses and without impacting the execution of growth in our existing portfolio.

Speaker #3: Rather than the true increases in our discretionary spend. Adjusted EBITDA for the quarter was $5.7 million or 24% of revenue. We continue to expect to achieve a greater than 30% adjusted EBITDA margin for the full year, and believe we are on track to reach our goal of a 50% adjusted EBITDA margin by 2028.

Speaker #3: The results are a testament to the effectiveness and scalability of our unique rare disease model and infrastructure. Our nimble, proven infrastructure has allowed us to launch two new products in 2026 so far, without a significant increase in expenses and without impacting the execution of growth in our existing portfolio.

Speaker #3: We expect to see similar trends in the coming quarters as we continue to quickly grow revenue and bring to market new rare disease therapies.

Sean Brynjelsen: We expect to see similar trends in the coming quarters as we continue to quickly grow revenue and bring to market new rare disease therapies. Turning to product specifics, I will start with our exciting new launch of HEMANGEOL, which took place just a matter of days ago. HEMANGEOL is the only FDA-approved treatment for infantile hemangiomas, which are non-cancerous vascular tumors that appear shortly after birth and can sometimes lead to serious complications, including loss of vision, trouble breathing, or permanent disfigurement. HEMANGEOL treatment is typically initiated as soon as an infant is diagnosed, which is usually before 6 months of age, and patients normally stay on treatment for approximately 6 months. HEMANGEOL is a remarkable product with impressive efficacy and clinically proven safety. The results are often life-changing for patients and their families.

Speaker #3: Turning to product specifics, I will start with our exciting new launch of Hemangiol, which took place just a matter of days ago. Hemangiol is the only FDA-approved treatment for infantile hemangiomas, which are non-cancerous vascular tumors that appear shortly after birth and can sometimes lead to serious complications, including loss of vision, trouble breathing, or permanent disfigurement.

Speaker #3: Hemangiol treatment is typically initiated as soon as an infant is diagnosed, which is usually before six months of age and patients normally stay on treatment for approximately six months.

Speaker #3: Hemangiol is a remarkable product with impressive efficacy and clinically proven safety. The results are often life-changing for patients and their families. If you have not done so, I encourage you to search for before and after photos of severe infantile hemangiomas treated with Hemangiol to gain some perspective on how dramatic the results can be.

Sean Brynjelsen: If you have not done so, I encourage you to search for before and after photos of severe infantile hemangiomas treated with HEMANGEOL to gain some perspective on how dramatic the results can be. With HEMANGEOL, we saw an opportunity to add meaningful value to an important treatment by, among other things, streamlining therapy access and distribution and improving patient support. HEMANGEOL is a time-sensitive treatment, and we're dedicated to helping patients start therapy quickly and supporting families from the moment of prescription through treatment. HEMANGEOL expanded Eton into a third therapeutic area, pediatric dermatology, and importantly brought an incredibly experienced team into the organization that was already promoting HEMANGEOL. This team has spent nearly a decade supporting physicians, families, and patients within this community and have built deep, long-standing relationships focused on helping children access HEMANGEOL.

Speaker #3: With Hemangiol, we saw an opportunity to add meaningful value to an important treatment by, among other things, streamlining therapy access and distribution, and improving patient support.

Speaker #3: Hemangiol is a time-sensitive treatment, and we're dedicated to helping patients start therapy quickly, and supporting families from the moment of prescription through treatment. Hemangiol expanded Eaton into a third therapeutic area, pediatric dermatology, and importantly, brought an incredibly experienced team into the organization that was already promoting Hemangiol.

Speaker #3: This team has spent nearly a decade supporting physicians, families, and patients within this community, and have built deep, long-standing relationships focused on helping children access Hemangiol.

Speaker #3: One of the things we were most excited about in this acquisition was the opportunity to combine that experience and commitment to patients with Eaton's rare disease commercialization model and patient support infrastructure.

Sean Brynjelsen: One of the things we were most excited about in this acquisition was the opportunity to combine that experience and commitment to patients with Eton's rare disease commercialization model and patient support infrastructure. We believe Eton's focused rare disease approach, including Eton Cares high-touch patient support, specialty pharma infrastructure, and our no patient left behind philosophy will further strengthen the work this team has already been doing for years on behalf of patients and families. We have already implemented several changes that we believe will improve the therapy experience for patients and providers and add value, including we have streamlined the distribution, shifting to a rare disease-focused model that reduces fragmentation and improves visibility and efficiency during the patient journey.

Speaker #3: We believe Eaton's focused rare disease approach including Eaton Cares, high-touch patient support, specialty pharma infrastructure, and our no-patient left-behind philosophy will further strengthen the work this team is already been doing for years on behalf of patients and families.

Speaker #3: We have already implemented several changes that we believe will improve the therapy experience for patients and providers and add value, including: we have streamlined the distribution, shifting to a rare disease-focused model that reduces fragmentation and improves visibility and efficiency during the patient journey.

Speaker #3: Under the prior structure, prescriptions could move across multiple pharmacies and intermediaries, which often create a confusion for providers and families around where prescriptions were located, who was responsible for fulfillment, and how to resolve access issues quickly.

Sean Brynjelsen: Under the prior structure, prescriptions could move across multiple pharmacies and intermediaries, which often created confusion for providers and families around where prescriptions were located, who was responsible for fulfillment, and how to resolve access issues quickly. Secondly, we have launched our full Eton Cares patient support program, including streamlined $0 copay support for commercially insured patients and expanded patient assistant programs for uninsured and underinsured families. Previously, many families were paying approximately $55 per bottle and in some cases more than $100 per month, depending on dosing and coverage, while access to copay support and financial assistance was often fragmented and difficult for offices and families to navigate.

Speaker #3: Secondly, we have launched our full Eaton Cares patient support program, including streamlined $0 copay support for commercially insured patients, and expanded patient assistant programs for uninsured and underinsured families.

Speaker #3: Previously, many families were paying approximately $55 per bottle, and in some cases more than $100 per month, depending on dosing and coverage. While access to copay support and financial assistance was often fragmented and difficult for offices and families to navigate.

Speaker #3: Third, we are already building upon the strong physician relationships the team developed over many years and are taking the next step in expanding engagement with thought leaders, professional societies, and broader healthcare provider education initiatives to further increase awareness, education, and appropriate patient identification within the treatment window.

Sean Brynjelsen: Third, we are already building upon the strong physician relationships the team developed over many years and are taking the next step in expanding engagement with thought leaders, professional societies, and broader healthcare provider education initiatives to further increase awareness, education, and appropriate patient identification within the treatment window. Lastly, we are actively engaging with the patient advocacy community around HEMANGEOL and are increasing our investment and long-term commitment to advocacy partnerships, caregiver education, and community support initiatives. Our goal is not simply to support the therapy itself, but to become a more active and visible partner to the broader patient community through meaningful engagement, education, and resources. The responses from advocacy organizations and professional society partners have been incredibly positive, them welcoming Eton's commitment to expanding patient support, access resources, and long-term investment in the community.

Speaker #3: And lastly, we are actively engaging with the patient advocacy community around Hemangiol and are increasing our investment in long-term commitment to advocacy partnerships, caregiver education, and community support initiatives.

Speaker #3: Our goal is not simply to support the therapy itself, but to become a more active and visible partner to the broader patient community through meaningful engagement, education, and resources.

Speaker #3: The responses from advocacy organizations and professional society partners have been incredibly positive. Them welcoming Eaton's commitment to expanding patient support, access resources, and long-term investment in the community.

Sean Brynjelsen: Historically, we believe there has been significant usage of off-label adult propranolol formulations that are approved for cardiovascular indications. These adult formulations contain alcohol, sugar, and other preservatives that are not suitable for infants. By contrast, HEMANGEOL, which is the only FDA-approved treatment for infantile hemangiomas, was formulated specifically for infants without containing alcohol or sugar. During our due diligence, we found that the primary reasons for the using off-label adult product were, 1, the fact that the adult product had a lower copay than the $55 HEMANGEOL copay, and 2, a lack of awareness among parents and prescribers about the alcohol and other excipients that are present in the adult formulation. We have addressed the copay issue with our $0 copay program, and we plan to address the awareness issue through our investments and efforts in new campaigns targeted at both prescribers and caregivers.

Speaker #3: Historically, we believe there has been significant usage of off-label adult propranolol formulations that are approved for cardiovascular indications. These adult formulations contain alcohol, sugar, and other preservatives that are not suitable for infants.

Speaker #3: By contrast, Hemangiol, which is the only FDA-approved treatment for infantile hemangiomas, was formulated specifically for infants without containing alcohol or sugar. During our due diligence, we found that the primary reasons for the using off-label adult product were, one, the fact that the adult product had a lower copay than the $55 Hemangiol copay, and two, a lack of awareness among parents and prescribers about the alcohol and other excipients that are present in the adult formulation.

Speaker #3: We have addressed the copay issue with our $0 copay program, and we plan to address the awareness issue through our investments and efforts in new campaigns targeted at both prescribers and caregivers.

Sean Brynjelsen: There are still many variables and uncertainties involved with the launch. Our preliminary view is that between our free drug patient assistance program, government patients, and certain commercial payer contracts we inherited, we estimate that around 60% to 65% of the volume may be near zero revenue, which should result in an estimated average net price per patient of around $8,000 to $10,000 per full course of therapy. Of course, this is a preliminary estimate, and a number of factors such as patient mix could cause the actual number to differ materially. We should have more precise insight by our next earnings call in August, and we'll update you accordingly.

Speaker #3: There are still many variables and uncertainties involved with the launch. However, our preliminary view is that between our free drug patient assistance program, government patients, and certain commercial payer contracts, we inherited, we estimate that around 60 to 65 percent of the volume may be near zero revenue.

Speaker #3: Which should result in an estimated average net price per patient of around $8,000 to $10,000 per full course of therapy. Of course, this is a preliminary estimate, and a number of factors such as patient mix could cause the actual number to differ materially.

Speaker #3: We should have more precise insight by our next earnings call in August, and we'll update you accordingly. While it is a massive undertaking to get thousands of patients transferred from a broad distribution to a new single pharmacy in such a short period, our team has been preparing and working hard to complete it quickly and ensure that the process is as smooth as possible for families and prescribers.

Sean Brynjelsen: While it is a massive undertaking to get thousands of patients transferred from a broad distribution to a new single pharmacy in such a short period, our team has been preparing and working hard to complete it quickly and ensure that the process is as smooth as possible for families and prescribers. We're still early in HEMANGEOL's launch, relaunch I should say, we have experienced cooperation from certain prior dispensing pharmacies, which we believe will help the situation and the transition. HEMANGEOL's revenue contribution to Q2 results is expected to be limited, since it is launching mid-quarter and it may take several weeks or months to get patients fully transferred to the new pharmacy. We expect to start seeing a sizable revenue contribution beginning in Q3.

Speaker #3: We're still early in Hemangiol's launch—relaunch, I should say—but we have experienced cooperation from certain prior dispensing pharmacies, which we believe will help the situation and the transition.

Speaker #3: Hemangiol's revenue contribution to second-quarter results is expected to be limited. Since it is launching mid-quarter and it may take several weeks or months to get patients fully transferred to the new pharmacy, we expect to start seeing a sizable revenue contribution beginning in the third quarter, and while it is still too early in the launch to say definitively, since there are a number of variables yet to play out, we believe that Hemangiol could be our largest product in 2027.

Sean Brynjelsen: While it is still too early in the launch to say definitively, since there are a number of variables yet to play out, we believe that HEMANGEOL could be our largest product in 2027. Eton also launched DESMODA during the Q1, shortly after its FDA approval. As the first and only FDA-approved desmopressin oral solution, DESMODA is a game-changer for patients because it eliminates the need to split or crush tablets, allowing for very precise dosing. Thought leaders in the community have described DESMODA as potentially transformative given how individualized desmopressin dosing is from patient to patient, and even within the same patient over time throughout their treatment journey.

Speaker #3: Eton also launched Osmoda during the first quarter, shortly after its FDA approval. As the first and only FDA-approved desmopressin oral solution, Osmoda is a game changer for patients because it eliminates the need to split or crush tablets, allowing for very precise dosing.

Speaker #3: Thought leaders in the community have described Desmoda as potentially transformative given how individualized desmopressin dosing is from patient to patient. And even within the same patient, over time, throughout their treatment journey, historically, patients and providers have often had to rely on suboptimal workarounds using tablets, nasal sprays, injections, none of which are designed to provide the combination of oral administration and precise flexible dose titration that many patients require.

Sean Brynjelsen: Historically, patients and providers have often had to rely on suboptimal workarounds using tablets, nasal sprays, injections, none of which are designed to provide the combination of oral administration and precise, flexible dose titration that many patients require. During our March earnings call, we were just a few weeks into the DESMODA launch, but I share that I was encouraged by what I saw. I'm pleased to say the excitement level has continued in April and thus far in May. I am proud of our operations and commercial team's exceptional launch plan and execution, and I believe that it was the best-executed product launch at Eton's history and sets a new standard for future product launches. Since day one of the launch, peer-to-peer education efforts have complemented targeted field engagement across key accounts, supporting early awareness and clinical dialogue.

Speaker #3: During our March earnings call, we were just a few weeks into the Desmoda launch, but I shared that I was encouraged by what I saw.

Speaker #3: I am pleased to say the excitement level has continued in April and thus far in May. I am proud of our operations and commercial team's exceptional launch plan and execution, and I believe that it was the best executed product launch at Eaton's history and sets a new standard for future product launches.

Speaker #3: Since day one of the launch, peer-to-peer education efforts have complemented targeted field engagement across key accounts supporting early awareness and clinical dialogue. In parallel, Eaton has had strong opportunities to engage with thought leaders at national and regional conferences.

Sean Brynjelsen: In parallel, Eton has had strong opportunities to engage with thought leaders at national and regional conferences. Earlier this month, our team attended two of the most important endocrinology conferences of the year, the Pediatric Endocrinology Nursing Society and Pediatric Endocrine Society annual meetings. The timing was very favorable coming in the midst of our DESMODA launch, and our team was able to take advantage of the opportunity to engage with hundreds of leading pediatric endocrinology prescribers about DESMODA. Importantly, the feedback was overwhelmingly positive. We believe the launch has also opened doors to important institutions that historically could be difficult to access, creating broader opportunities for meaningful dialogue not only around DESMODA, but across the rest of our pediatric endocrinology portfolio, including Alkindi, INCRELEX, and KHINDIVI. We believe the impact of these engagements will continue to build in the coming weeks and months.

Speaker #3: Earlier this month, our team attended two of the most important endocrinology conferences of the year. The pediatric endocrinology nursing society and pediatric endocrine society annual meetings.

Speaker #3: The timing was very favorable coming in the midst of our Desmoda launch, and our team was able to take advantage of the opportunity to engage with hundreds of leading pediatric endocrinology prescribers about Desmoda.

Speaker #3: Importantly, the feedback was overwhelmingly positive. We believe the launch has also opened doors to important institutions that historically could be difficult to access, creating broader opportunities for meaningful dialogue not only around Desmoda but across the rest of our pediatric endocrinology portfolio including Alkindi and CRELEX and KINDIVI.

Speaker #3: We believe the impact of these engagements will continue to build in the coming weeks and months. Desmoda fulfills a very specific need, and we've seen an enthusiastic reception from prescribers.

Sean Brynjelsen: DESMODA fulfills a very specific need, and we've seen an enthusiastic reception from prescribers. DESMODA is being promoted by the same team of pediatric endocrinology rare disease specialists who promote Alkindi, KHINDIVI, and INCRELEX. So far, the product launch is meeting my high expectations, and we continue to believe it could reach peak sales of $30 to 50 million. Turning to the rest of our commercial products, the story remains consistent with that of the last few quarters. We continue to see strong, steady growth from across our diversified portfolio. INCRELEX, ALKINDI SPRINKLE, and Galzin all provided major growth contributions in the quarter. As we have discussed before, we believe we have captured relatively small share of the market opportunity for all three of these key growth products. We continue to believe that they have long runways for growth ahead of them.

Speaker #3: Desmoda is being promoted by the same team of pediatric endocrinology rare disease specialists who promote Alkindi, KINDIVI, and CRELEX. So far, the product launch is meeting my high expectations, and we continue to believe it could reach peak sales of 30 to 50 million.

Speaker #3: Turning to the rest of our commercial products, the story remains consistent with that of the last few quarters. We continue to see strong, steady growth from across our diversified portfolio, and CRELEX, Alkindi Sprinkle, and Galzen all provided major growth contributions in the quarter.

Speaker #3: As we have discussed before, we believe we have captured relatively small share of the market opportunity for all three of these key growth products.

Speaker #3: So we continue to believe that they have long runways for growth ahead of them. On the R&D side of Eaton, we have made strong progress advancing our pipeline and achieved a number of critical milestones in recent months.

Sean Brynjelsen: On the R&D side of Eton, we have made strong progress advancing our pipeline and achieved a number of critical milestones in recent months. First, on INCRELEX, the label harmonization program, I am pleased to share that we now have received the FDA's clearance to proceed with our proposed clinical study. We intend to initiate the study in H2 of this year. The study will track approximately 30 patients over 5 years or until they reach full adult height, with a primary endpoint of change in average annual height velocity at month 12 compared to pretreatment height velocity. As we've discussed extensively, we see a significant opportunity to expand the potential patient population by harmonizing the US definition of severe primary IGF-I deficiency to match that of Europe.

Speaker #3: First, on CRELEX, the label harmonization program I am pleased to share that we now have received the FDA's clearance to proceed with our proposed clinical study.

Speaker #3: We intend to initiate the study in the second half of this year. The study will track approximately 30 patients over five years, or until they reach full adult height, with a primary endpoint of change in average annual height velocity at month 12 compared to pre-treatment height velocity.

Speaker #3: As we've discussed extensively, we see a significant opportunity to expand the potential patient population by harmonizing the US definition of severe primary IGF-1 deficiency to match that of Europe.

Speaker #3: If we are successful with harmonizing the label, we believe the CRELEX market opportunity could increase fivefold in the United States. On ET-700, our extended relief zinc acetate, we announced that a pilot study has been initiated to test the efficacy of ET-700 relative to Galzen and placebo in a double-blinded, placebo-controlled clinical trial comprised of 36 healthy volunteers.

Sean Brynjelsen: If we are successful with harmonizing the label, we believe the INCRELEX market opportunity could increase five-fold in the United States. On ET-700, our extended-release zinc acetate, we announced that a pilot study has been initiated to test the efficacy of ET-700 relative to Galzin and placebo in a double-blinded, placebo-controlled clinical trial comprised of 36 healthy volunteers. PET scans with radioactive tracer copper will compare the effects on intestinal copper absorption of Galzin, taken three times daily, ET-700 taken twice daily, plus a placebo taken daily as well. A placebo also, I'm sorry, taken three times daily. The study treatment will last four weeks, and we expect to have the top-line results in H2 2026. If early results are positive, they could lead to a pivotal clinical study in early 2027.

Speaker #3: PET scans with radioactive tracer copper will compare the effects on intestinal copper absorption of Galzen taken three times daily. ET-700 taken twice daily plus a placebo taken daily as well.

Speaker #3: And a placebo also, I'm sorry, taken three times daily. The study treatment will last four weeks, and we expect to have the top-line results in the second half of 2026.

Speaker #3: If early results are positive, they could lead to a pivotal clinical study in early 2027. We believe ET-700 could exceed 100 million of States once it's approved.

Sean Brynjelsen: We believe ET-700 could exceed $100 million of annual peak sales in the United States once it's approved. On our KHINDIVI label expansion program, where we are seeking to expand the FDA-approved range of the label beyond the current label of ages 5 and up, we are wrapping up final patient dosing in our bioequivalency study and expect to have results in the next couple of months. If successful, that will allow us to file our supplemental filing to the existing NDA in Q3 and potentially receive approval in Q2 2027. We have continued to see tepid uptake of KHINDIVI with its current restrictive label and believe the expanded label will be the catalyst to see greater adoption. In addition, we progressed Amglidia, our oral liquid glyburide program for the treatment of neonatal diabetes.

Speaker #3: On our KINDIVI label expansion program, where we are seeking to expand the FDA-approved range of the label beyond the current label of ages 5 and up, we are wrapping up final patient dosing in our bioequivalency study and expect to have results in the next couple of months.

Speaker #3: If successful, that will allow us to file our supplemental filing to the existing NDA in the third quarter and potentially receive approval in the second quarter of 2027.

Speaker #3: We have continued to see tepid uptake of KINDIVI with its current restrictive label and believe the extended label will be the catalyst to see greater adoption.

Speaker #3: In addition, we progressed MGLIDIA, our oral liquid glyburide program for the treatment of neonatal diabetes. MGLIDIA is approved and widely used in Europe, but has not been approved in the United States.

Sean Brynjelsen: Amglidia is approved and widely used in Europe, but has not been approved in the United States. Currently, there are no FDA-approved treatments for neonatal diabetes, so it represents a critical unmet need. Amglidia is a perfect strategic fit for us. It treats an extremely rare condition, impacting only a few hundred patients in the United States, and it is prescribed by pediatric endocrinologists, two characteristics that we specialize in here at Eton. We recently filed an IND with the FDA, which should allow us to initiate the required bioavailability study by July of this year. Based on our current timelines, we expect to submit the product's NDA in Q4, which would give us the potential to deliver a high-value product launch in 2027. As you've heard this afternoon, it's been a great start to the year, and we're well-positioned for an exceptional 2026.

Speaker #3: Currently, there are no FDA-approved treatments for neonatal diabetes, so it represents a critical unmet need. MGLIDIA is a perfect strategic fit for us. It treats an extremely rare condition impacting only a few hundred patients in the United States and it is prescribed by pediatric endocrinologists to characteristics that we specialize in here at Eaton.

Speaker #3: We recently filed an IND with the FDA, which should allow us to initiate the required bioavailability study by July of this year. Based on our current timelines, we expect to submit the product's NDA in the fourth quarter which would give us the potential to deliver a high-value product launch in 2027.

Speaker #3: As you've heard this afternoon, it's been a great start to the year and we're well positioned for an exceptional 2026. The momentum from our existing products remains strong, we've added two additional high-value product launches, we're meaningfully adding an advancing our pipeline to fuel long-term growth, and as always, we're continuing to pursue acquisition opportunities to expand our portfolio and add incremental revenue while maintaining our disciplined approach to operating expenses.

Sean Brynjelsen: The momentum from our existing products remains strong. We've added two additional high-value product launches. We're meaningfully adding and advancing our pipeline to fuel long-term growth. As always, we're continuing to pursue acquisition opportunities to expand our portfolio and add incremental revenue while maintaining our disciplined approach to operating expenses. Based on the strong performance in Q1, I believe we remain on track to reach the following four long-term goals I outlined in March. Number 1, build the largest rare disease portfolio in the US. 2, reach a $200 million annual revenue run rate by end of 2027. 3, achieve a 50% adjusted EBITDA margin profile in 2028. 4, reach $500 million of annual revenue in 2030. Thank you for your ongoing support, and we look forward to keeping you apprised of the many exciting milestones ahead.

Speaker #3: Based on the strong performance in Q1, I believe we remain on track to reach the following four long-term goals I outlined in March. Number one, build the largest rare disease portfolio in the United States.

Speaker #3: Two, reach a $200 million annual revenue run rate by end of 2027. Three, achieve a 50% adjusted EBITDA margin profile in 2028. And fourth, reach $500 million of annual revenue in 2030.

Speaker #3: Thank you for your ongoing support and we look forward to keeping you apprised of the many exciting milestones ahead. Before I turn it over to James for the final time, I'd like to take a moment to personally thank him for his contributions and dedication to the organization over the last four years.

Sean Brynjelsen: Before I turn it over to James for the final time, I'd like to take a moment to personally thank him for his contributions and dedication to the organization over the last 4 years. He's done an exceptional job leading our finance department during a period of rapid growth as we grew from 2 to 10 commercial products in short order. Thank you, James, for all you've done on behalf of Eton. On 1 June, Judith Matthews will take over as CFO. Judith joined us last month as Executive Vice President, Accounting and Finance and has been quickly getting caught up to speed on our business. Judith previously led finance departments of high-growth pharmaceutical companies, we're excited to have her on board. With that, I'll turn it over to James to discuss the financial results. James?

Speaker #3: He's done an exceptional job leading our finance department during a period of rapid growth, as we grew from 2 to 10 commercial products in short order.

Speaker #3: Thank you, James, for all you've done on behalf of Eaton. On June 1st, Judy Matthews will take over as CFO. Judy joined us last month as executive vice president of accounting and finance and has been quickly getting caught up to speed on our business.

Speaker #3: Judy previously led finance departments of high-growth pharmaceutical companies, and we're excited to have her on board. With that, I'll turn it over to James to discuss the financial results.

Speaker #3: James?

Speaker #2: Thank you, Sean. First quarter revenue increased 40% to $24.3 million, compared to 17.3 million in the first quarter of 2025, and we had $3.3 million of licensing revenue in the first quarter of 2025.

James Gruber: Thank you, Sean. Q1 revenue increased 40% to $24.3 million, compared to $17.3 million in Q1 2025. We had $3.3 million of licensing revenue in Q1 2025. Product sales and royalty revenue were $24.3 million during the quarter, compared to $14.0 million in the prior year period, an increase of 73%, driven by strong growth across the portfolio, in particular, INCRELEX, ALKINDI SPRINKLE, Galzin, and carglumic acid, as well as from the addition of sales from KHINDIVI, which was approved and launched in mid-2025. Gross profit for the quarter was $14.7 million, compared with $9.9 million in the prior year period, an increase of 49%, primarily due to increased product sales.

Speaker #2: Product sales and royalty revenue were $24.3 million during the quarter, compared to $14.0 million in the prior year period—an increase of 73%, driven by strong growth across the portfolio, and in particular, INCRELEX, Alkindi Sprinkle, Galsen, and Carglumic Acid.

Speaker #2: As well as from the addition of sales from KINDIVI, which was approved and launched in mid-2025. Gross profit for the quarter was $14.7 million, compared with $9.9 million in the prior-year period.

Speaker #2: An increase of 49%, primarily due to increased product sales. Adjusted gross profit, which adjusts for the impact of acquired inventory step-up adjustments and intangible amortization, was $16.2 million in the first quarter of 2026, or 67% of revenue.

James Gruber: Adjusted gross profit, which adjusts for the impact of acquired inventory step-up adjustments and intangible amortization, was $16.2 million in Q1 2026, or 67% of revenue, compared to adjusted gross profit of $12.0 million and 69% of revenue in the prior year period. Q1 2026 included revenue from INCRELEX sales outside the US, which was dilutive to gross margin. We continue to expect to deliver full-year 2026 adjusted gross margin of at least 70% and reach between 75% and 80% in the coming years. HEMANGEOL and DESMODA are both expected to have gross margin profiles well above our historic company average.

Speaker #2: Compared to adjusted gross profit of $12.0 million and 69% of revenue in the prior year period. The first quarter of 2026 included revenue from INCRELEX sales outside the US, which was dilutive to gross margin.

Speaker #2: We continue to expect to deliver full-year 2026 adjusted gross margin of at least 70% and reach between $75 and 80% in the coming years.

Speaker #2: Temangio and Desmota are both expected to have gross margin profiles well above our historic company average. R&D expenses for the quarter were $1.9 million, an increase of $0.7 million compared to $1.2 million in the prior year period.

James Gruber: R&D expenses for the quarter are $1.9 million, an increase of $0.7 million compared to $1.2 million in the prior year period, primarily due to higher clinical study expenses associated with the KHINDIVI label expansion and ET-700 development activities. We continue to expect full-year 2026 R&D spending to be above last year's $7.8 million, but less than $10 million. General and administrative expenses for the quarter were $10.4 million, compared with $9.2 million in the prior year period. On an adjusted basis, which removes the impact of share-based compensation, transaction-related costs, and other one-time expenses, G&A expense was $9.0 million compared to $7.3 million in the prior year period.

Speaker #2: Primarily due to higher clinical study expenses associated with the KINDIVI label expansion and ET700 development activities. We continue to expect full-year 2026 R&D spending to be above last year's $7.8 million but less than $10 million.

Speaker #2: General and administrative expenses for the quarter were $10.4 million, compared with $9.2 million in the prior year period. On an adjusted basis, which removes the impact of share-based compensation, transaction-related costs, and other one-time expenses, G&A expense was $9.0 million compared to $7.3 million in the prior year period.

James Gruber: The largest driver of the increase was higher FDA annual program fees since Eton no longer qualifies for the Orphan PDUFA exemption as we now exceed the revenue threshold required to qualify. These fees were responsible for $0.9 million of the year-over-year G&A increase. The remaining increase was largely due to incremental headcount to support the growing portfolio. Adjusted EBITDA for the Q1 2026 was $5.7 million or 24% of revenue, compared to $3.7 million or 21% of revenue in the Q1 2025, which had the benefit of licensing revenue. Our Adjusted EBITDA will likely see fluctuations quarter to quarter depending on the timing of R&D expenses and ex-US INCRELEX orders, but we expect the full year Adjusted EBITDA margin to be above 30%.

Speaker #2: Largest driver of the increase was higher FDA annual program fees since Eaton no longer qualifies for the orphan PDUFA exemption as we now exceed the revenue threshold required to qualify.

Speaker #2: These fees were responsible for $0.9 million of the year-over-year G&A increase. The remaining increase was largely due to incremental headcount to support the growing portfolio.

Speaker #2: Adjusted EBITDA for the first quarter of 2026 was $5.7 million, or 24% of revenue, compared to $3.7 million, or 21% of revenue, in the first quarter of 2025, which had the benefit of licensing revenue.

Speaker #2: Our adjusted EBITDA will likely see fluctuations quarter to quarter depending on the timing of R&D expenses and ex-US INCRELEX orders, but we expect the full-year adjusted EBITDA margin to be above 30%.

Speaker #2: Total company net income was $1.6 million for the quarter, compared to a net loss of $1.6 million in the prior year period. Net income per basic and diluted share during the quarter was $0.06 and $0.05, respectively, compared to a net loss per basic and diluted share of $0.06 in the prior year period.

James Gruber: Total company net income was $1.6 million for the quarter, compared to a net loss of $1.6 million in the prior year period. Net income per basic and diluted share during the quarter was $0.06 and $0.05 respectively, compared to a net loss per basic and diluted share of $0.06 in the prior year period. On a non-GAAP basis, we reported net income of $4.5 million for Q1 2026, compared to $2.4 million in the prior year period, and diluted earnings per share of $0.14 for Q1 2026, compared to $0.07 per share in the prior year period.

Speaker #2: On a non-GAAP basis, we reported net income of $4.5 million for the first quarter of 2026, compared to $2.4 million in the prior year period, and diluted earnings per share of $0.14 for the first quarter of 2026, compared to $0.07 per share in the prior year period.

Speaker #2: In the first quarter, we generated $7.4 million in cash flow from operations, paid $14 million for Hemangio, and finished the quarter with $19.7 million of cash on hand.

James Gruber: In the first quarter, we generated $7.4 million in cash flow from operations, paid $14 million for HEMANGEOL, and finished the quarter with $19.7 million of cash on hand. We recently amended our existing $30 million credit facility, which lowered our interest rate by approximately 200 basis points at no cost to Eton and no change to the end of 2027 maturity date. We remain in a very strong financial position and expect to see our cash balance grow significantly throughout the year, even with planned debt principal repayments. We expect to have significant excess cash at our disposal that can be used for accretive product acquisitions. Given our significant EBITDA generation and our diversified portfolio, we believe we'd have significant debt capacity available to us should a larger acquisition opportunity present itself.

Speaker #2: We recently amended our existing $30 million credit facility, which lowered our interest rate by approximately 200 basis points, at no cost to Eton and with no change to the end of 2027 maturity date.

Speaker #2: We remain in a very strong financial position and expect to see our cash balance grow significantly throughout the year, even with planned debt principal repayments.

Speaker #2: We expect to have significant excess cash at our disposal, that can be used for accretive product acquisitions. In addition, given our significant EBITDA generation and our diversified portfolio, we believe we would have significant debt capacity available to us show larger acquisition opportunity present itself.

Speaker #2: Before we conclude, I'd like to express my sincere gratitude to Sean, and the entire team here at Eton, for the opportunity to work alongside such a talented, dedicated, and passionate group of professionals.

James Gruber: Before we conclude, I'd like to express my sincere gratitude to Sean and the entire team here at Eton for the opportunity to work alongside such a talented, dedicated, and passionate group of professionals. It's been a privilege to make a small contribution to Eton's remarkable growth and success, and most importantly, to the company's mission of improving the lives of the rare disease patients we serve. I'm extremely appreciative of the relationships and accomplishments that we've shared, and I remain confident that Eton will experience continued success and make a lasting impact on the healthcare community for many years to come. This concludes our remarks on Q1 results. With that, we'll turn it back over to the operator for Q&A.

Speaker #2: It's been a privilege to make a small contribution to Eaton's remarkable growth and success, and most importantly, to the company's mission of improving the lives of the rare disease patients we serve.

Speaker #2: I'm extremely appreciative of the relationships and accomplishments that we've shared, and I remain confident that Eton will experience continued success and make a lasting impact on the healthcare community for many years to come.

Speaker #2: This concludes our remarks on first-quarter results, and with that, we'll turn it back over to the operator for Q&A.

Speaker #1: Thank you. At this time, we'll conduct the question-and-answer session. As a reminder to ask a question, you'll need to press star 11 on your telephone.

Operator: Thank you. At this time, we'll conduct a question and answer session. As a reminder, to ask a question, you'll need to 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. Our first question comes from the line of Madison El-Saadi of B. Riley Securities. Your line is now open.

Speaker #1: 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.

Speaker #1: In our first question concerning the line of medicine Asadi of BY Securities, your line is now open.

Speaker #3: Hi. Thanks for taking our question and congrats on the quarter. And James congrats on all the success here at Eaton, and I'm wishing you the best of luck.

Madison El-Saadi: All right. Thanks for taking our question. Congrats on the quarter. James, congrats on all the success here at Eton, and I'm wishing you the best of luck.

Speaker #4: Thanks, Madison.

James Gruber: Thanks, Madison.

Madison El-Saadi: Yeah, absolutely. When we look at the product level dollar contribution, behind your $10 million guide, maybe just walk us through that. We should probably assume this is Q4 loaded. Secondly, regarding the HEMANGEOL price, maybe walk us through the $8,000 per patient per year. How does this compare to the base price that Pierre Fabre had it set at? I'm guessing this captures a typical 6-month course. If you could, any clarity into the proportion of the 8,000 branded patients that are retaining coverage at this new list price. And maybe since it's still pretty early, you could just talk about kind of your expectations for that going forward. Thanks.

Speaker #3: So yeah, absolutely. So when we look at the product-level dollar contribution behind your $10 million guide, maybe just walk us through it. And we should probably assume this is for Q4.

Speaker #3: And then secondly, regarding the Hemangio price, maybe walk us through the $8,000 per patient per year. How does this compare to the base price that Pierre had it set at?

Speaker #3: And I’m guessing this captures a typical six-month course? And then, if you could, any clarity into the proportion of the 8,000 branded patients that are retaining coverage at this new list price?

Speaker #3: And maybe, since it's still pretty early, you could just talk about your expectations for that going forward. Thanks.

Speaker #5: Sure, Madison. Starting with your question on the guidance, the increase in guidance, the hemangio launch was a big part of that as we got more comfortable launching it and a little more insight into what we thought it could do this year.

James Gruber: Sure, Madison. Starting with your question on the guidance, increase in guidance. The HEMANGEOL launch was a big part of that as we got more comfortable launching it and a little more insight into what we thought it could do this year, as well as outperformance from the rest of our portfolio. You know, we had a strong Q1. We were happy with the results. We're seeing good trends already in Q2. We're happy with the DESMODA launch. A combination of everything, but HEMANGEOL was definitely one of the important drivers of that. In terms of your question on the net price, yes, we do expect to net more than it was previously netting.

Speaker #5: As well as outperformance from the rest of our portfolio. We had a strong Q1. We were happy with the results. We're seeing good trends already in Q2.

Speaker #5: We're happy with the Desmota launch. So a combination of everything, but hemangio was definitely one of the important drivers of that. In terms of your question on the net price, yes, we do expect to net more than it was previously netting.

James Gruber: We walked through roughly 60% to 65% of the patients will likely be non-revenue generating or very low revenue generating. It should average out to around that $8,000 to $10,000 net price per patient. That's our current estimate. Obviously, as you alluded to, it's still very early. We're only 2 weeks into it. I think it's too early to make any definitive statements to answer your question about the coverage. We historically have very good coverage on our products. We expect that to continue. Too early in the launch to make any statements about that.

Speaker #5: We walked through, roughly, 60 to 65 percent of the patients will likely be non-revenue-generating or very low-revenue-generating. But it should average out to the round.

Speaker #5: That 8 to 10 thousand dollar net price per patient, that's our current estimate. Obviously, as you alluded to, it's still very early. We're only two weeks into it.

Speaker #5: I think it's too early to make any definitive statements to answer your question about the coverage. We historically have very good coverage on our product, so we expect that to continue.

Speaker #5: But it's too early in the launch to make any statements about that.

Speaker #3: Understood. Thank you all.

Madison El-Saadi: Understood. Thank you all.

Speaker #1: Thank you. One moment for our next question. In our next question concerning the line of Charles Wallace of AT WinRight, your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Charles Wallace of H.C. Wainwright. Your line is now open.

Charles Wallace: Hi, thanks for taking my question. This is Charles. I'm for RK from H.C. Wainwright. For my first question, something kind of struck me on the call. You said that HEMANGEOL could be the largest product by 2027. I was just kind of curious, currently, like, on an annual run rate, like, what is currently the largest product currently sitting at for my first question? Thank you.

Speaker #6: Hi. Thanks for taking my question. This is Charles on for RK. From AT WinRight. So for my first question, something kind of struck me on the call.

Speaker #6: You said that hemangio could be the largest product by 2027. And I was just kind of curious, currently, on an annual run rate, what is currently the largest product currently sitting at from my perception?

Speaker #6: Thank you.

Sean Brynjelsen: Hi, Charles. This is Sean. We have indicated INCRELEX is our current largest product. That continues to grow as well. You know, with HEMANGEOL, we have obviously big expectations for it. We've transferred a large number of the patients over to. We're continuing that transfer process. We'll provide a little bit more color, I would imagine, on future calls, but we do wanna see how this ramps before we can, you know, maybe give some directional guidance on that. Historically, we have not broken out sales by product, but we've spoken descriptively of it, and I think we'll certainly do that and revise our guidance as it transpires.

Speaker #5: Hi, Charles. This is Sean. We have indicated AnchorLight is our current largest product. That continues to grow as well. With hemangio, we have, obviously, big expectations for it.

Speaker #5: We've transferred a large number of the patients over, and we're continuing that transfer process. We'll provide a little bit more color with some insight on future calls.

Speaker #5: But we do want to see how this ramps before we can maybe give some directional guidance on that. Historically, we have not broken out sales by product.

Speaker #5: But we've spoken descriptively of it, and I think we'll certainly do that and revise our guidance as it transpires.

Charles Wallace: Great. I guess for my second question, if I may. I guess where are you currently with the patient number for INCRELEX, and are you confident with the 120 patients at the end of the year?

Speaker #6: Great. And I guess for my second question, if I may. So I guess where are you currently with the patient number for Increlix? And are you confident with the 120 patients at the end of the year?

Speaker #5: Yeah. So again, we're not going to get into patient counts. Otherwise, I'll be giving patient count updates on every call. I can tell you that we're very much on track with what we've stated previously.

Sean Brynjelsen: Yeah. Again, we're not going to get into patient counts, otherwise I'll be giving patient count updates on every call. I can tell you that we're very much on track with what we've stated previously. We're very pleased with INCRELEX's performance. It, we add patients. It's been a great product and it's a reason why it's our largest. We are also looking at initiating that label expansion study. We do have significant plans for the product. And we'll keep everyone apprised as that enrollment occurs and as we get closer to being able to file that label update.

Speaker #5: We're very pleased with Increlix's performance. We have patients. It's been a great product. And it's a reason why it's our largest. We are also looking at initiating that label expansion study.

Speaker #5: So we do have significant plans for the product. And we'll keep everyone apprised as that enrollment occurs and as we get closer to update.

Charles Wallace: Sorry, one more question, if I may. I was just curious if, you know, as you're acquiring all these products, is it one specialty pharmacy that's handling all these drugs in the distribution?

Speaker #6: And sorry, one more question if I may. So I was just curious if as you're acquiring all these products, is it one specialty pharmacy that's handling all these drugs in the distribution?

Speaker #5: That is correct. As we that's a good question, actually, because we've been we certainly that's where we're at today. And as long as they can continue to service our needs and meet our objectives for our portfolio, we're very happy with them.

Sean Brynjelsen: That is correct. That's a good question actually, because we've been, you know, we certainly that's where we're at today. As long as they can continue to service our needs and meet our objectives for our portfolio, and we're very happy with them. We do have aspirations to have the largest rare disease portfolio in the industry, and if it ever comes a point where we think we need to add another specialty pharmacy, we'll do that. For right now we're very pleased with Anovo and the work that they do.

Speaker #5: But we do have aspirations to have the largest rare disease portfolio in industry. And if it ever comes a point where we think we need to add another specialty pharmacy, we'll do that.

Speaker #5: But for right now, we're very pleased with the Novo and the work that they do.

Speaker #6: Great. Thank you so much for taking my questions.

Charles Wallace: Great. Thank you so much for taking the questions.

Speaker #5: Pleasure.

Sean Brynjelsen: Pleasure.

Speaker #1: Thank you. One moment for our next question. Our next question concerns the line of Chase Knickerbocker of Greg Holland. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Chase Knickerbocker of Craig-Hallum. Your line is now open.

Speaker #7: Good afternoon. Thanks for taking the question. And congrats on another nice quarter here. Sean, could you maybe just bridge the kind of changing guidance?

Chase Knickerbocker: Good afternoon. Thanks for taking the question, and congrats on another nice quarter here. Sean, could you maybe just bridge the kind of change in guidance? Was the updated raised guidance, was it solely driven by kind of refining the HEMANGEOL model? You know, what else drove it as far as how your assumptions changed from March to now? Thanks.

Speaker #7: Was the updated raised guidance, was it solely driven by kind of refining the hemangio model? Or what else drove it as far as how your assumptions changed from March to now?

Speaker #7: Thanks.

Speaker #5: Sure. So as David had indicated earlier, we have driven we've raised that guidance for a number of factors. Certainly, hemangio was a key part of that.

Sean Brynjelsen: Sure. As David had indicated earlier, we have driven, we've raised that guidance for a number of factors. Certainly HEMANGEOL was a key part of that. Two, our base business, the commercial sales levels, continue to be very strong. As we're going into, you know, the past few weeks, we see that momentum continue. You know, really across the board we've been kind of hitting our numbers that we expect. I guess the third thing is DESMODA, that launch is bringing in a significant number of patients. We're very happy with the launch. We just got out of a endocrinology meeting where there's a tremendous amount of excitement on that product. I'm hoping to provide a little bit more clarity on what we think that ultimately that product can do.

Speaker #5: Two, our base business, the commercial sales levels continue to be very strong. And as we're going into the past few weeks, we see that momentum continue.

Speaker #5: Really, across the board, we've been kind of hitting our numbers that we expect. And I guess the third thing is Desmota that launch is bringing in significant number of patients.

Speaker #5: We're very happy with the launch. We just got out of an endocrinology meeting where there's a tremendous amount of excitement on that product. And I'm hoping to provide a little bit more clarity on what we think that ultimately that product can do.

Sean Brynjelsen: We've given that guidance of 30 to 50. We'll update that, I imagine, on our, on future calls and, you know, we'll see how. All of that kind of came together. We said more than 120, so obviously it's more than 120. We'll leave it at that, and we'll see what happens.

Speaker #5: We've given off that guidance of 30 to 50. We'll update that, I imagine, in our future calls. And we'll see how. But all of that kind of came together and we said more than 120.

Speaker #5: So obviously, it's more than 120. We don't we'll leave it at that. And we'll see what happens.

Speaker #7: Helpful. And maybe if I can draw some cross-currents between kind of your experiences with Gelsyn and hemangio here. I mean, you guys did a pretty good job of switching those patients pretty quickly into your distribution platform.

Chase Knickerbocker: Helpful. Maybe if I can draw some crosscurrents between kind of your experiences with Galzin and HEMANGEOL here. You guys did a pretty good job of switching those patients pretty quickly into your distribution platform. Maybe talk about some of the learnings that you had from Galzin and the potential for any sort of opportunity to do a little bit better than you guys are expecting as far as the kind of switching of those patients into your platform. Because again, we did outperform on Galzin. Maybe just kinda talk about if that's a fair comparison and just some of your learnings.

Speaker #7: I mean, maybe talk about some of the learnings that you had from Gelsyn and potential the potential for any sort of opportunity to do a little bit better than you guys are expecting as far as the kind of switching of those patients into your platform.

Speaker #7: Because again, we did outperform on Gelsyn. So maybe just kind of talk about if that's a fair comparison and just some of your learnings.

Speaker #5: Sure. So Chase, I'm going to turn that question over to our chief commercial officer, Ipek. Ipek?

Sean Brynjelsen: Sure. Chase, I'm gonna turn that question over to our Chief Commercial Officer, Ipek. Ipek.

Speaker #8: Hi, Chase. Thank you for the question. That is actually a great parallel. There are a few things that are very similar, and a few things that are different.

Ipek Erdogan-Trinkaus: Hi, Chase. Thank you for the question. That is actually a great parallel. Few things that are very similar and few things that are different. I think with Galzin it was all open network. It was multiple pharmacies. We actually didn't even have the luxury at the time of collaborating with those pharmacies, so we kind of had to find all those patients ourselves. I think we did a very good job, very effective job. We knew at the time, without any numbers, anything that we inherited from the previous ownership, that there was around 200 to 300 patients that were already on Galzin. I think we already shared before, we are already over those numbers.

Speaker #8: I think with Gelsyn, it was all open network. It was multiple pharmacies. We actually didn't even have the luxury at the time of collaborating with those pharmacies.

Speaker #8: So we kind of had to find all those patients ourselves. And I think we did a very good job, very effective job. And we knew at the time without any numbers, anything that we inherited from the previous ownership, that there was around 200 to 300 patients that were already on Gelsyn.

Speaker #8: And I think we already shared before, we are already over those numbers. We are about 300 patients already. Within the course of a year, which obviously was a very effective transition, without having any collaboration.

Ipek Erdogan-Trinkaus: We are about 300 patients already, you know, within the course of a year, which obviously was a very effective transition without having any collaboration. I think with HEMANGEOL, the positives there obviously are there were 17 pharmacies, but this is also 8,000 patients. It's a big, much bigger, existing base of active patients and, basically pulling down from some local small pharmacies, some big pharmacies like Walgreens. We've been working very hard for about 60 days between our sales team putting transition agreements with some of those pharmacies, as well as Anovo Specialty Pharmacy pulling those transfers through, which has been very good. Almost 60% of that 8,000 base we were able to actually put some sort of a collaboration with the former pharmacies to agree to transfer the patients.

Speaker #8: I think with hemangio, the positives there obviously are there were 17 pharmacies, but this is also 8,000 patients. It's a big, much bigger existing base of active patients.

Speaker #8: And basically pulling down from some local small pharmacies, some big pharmacies like Walgreens. So we've been working very hard for the past 60 days between our sales team, putting transition agreements with some of those pharmacies, as well as Innova, our specialty pharmacy, pulling those transfers through, which has been very good.

Speaker #8: Almost 60% of that 8,000 base we were able to actually put some sort of a collaboration with the former pharmacies to agree to transfer the patients.

Speaker #8: So, I think that we've been very good. But at the same time, it's a much bigger volume of patients to serve, and we need to make sure that there's continuity of care.

Ipek Erdogan-Trinkaus: That's because we, you know, we've been very good, but at the same time, it's a much bigger volume of patients to serve and make sure that there's continuity of care. Nobody's behind without their drug. It's a much shorter course of therapy. That's another important distinction. With Galzin, obviously, it's a lifetime chronic therapy, so we still are finding those patients who were on Galzin, but also converting from patients who were never been on Galzin on the competitive over-the-counter non-RX therapies. That's the goal right now, that conversion. With HEMANGEOL, it's the time is of essence because we need to get those 8,000 patients into our system, serve them without any disruption, but also it's a 6-month therapy window, so we need to start acquiring new patients as well.

Speaker #8: Nobody's behind without their drug. It's a much shorter course of therapy. That's another important distinction with Gelsyn. Obviously, it's a lifetime chronic therapy. So we still are finding those patients who were on Gelsyn, but also converting from patients who were never been on Gelsyn on the competitive over-the-counter non-Rx therapies.

Speaker #8: So that's the goal right now of that conversion. But with hemangio, it's the time is of essence because we need to get those 8,000 patients into our system, serve them without any disruption, but also it's a six-month therapy window.

Speaker #8: So we need to start acquiring new patients as well.

Speaker #7: Helpful color. Thank you. And then maybe just last from me, James, one last question for you here. Just as we think about the magnitude of the amount of OUS revenue for Incrilex in the quarter, if you could share that.

Chase Knickerbocker: Helpful color. Thank you. Then maybe just last from me, James, you know, one last question for you here. Just as we think about the magnitude of the amount of OUS revenue for INCRELEX in the quarter, if you could share that, and then just what the associated COGS was of that. Certainly wish you all the best in your next endeavors, and it's been a pleasure working with you.

Speaker #7: And then just what the associated COGS was of that. And certainly wish you all the best in your next endeavors in it's been a pleasure working with you.

James Gruber: Likewise. Thanks, Chase. We have, as far as the diluted margin profile on our ex-US INCRELEX revenue, it's about two to one, so $2 of COGS to $1 of revenue. It was low single-digit millions in Q1. We should have maybe a handful of similar orders. I think previously we have estimated annual ex-US INCRELEX revenue of $2 to 3 million, and that's still the estimate for 2026.

Speaker #5: Likewise. Thanks, Chase. So we have as far as the diluted margin profile on our XUS Incrilex revenue, it's about 2 to 1. So $2 of COGS to $1 of revenue.

Speaker #5: And it was low single-digit millions in Q1. We should have maybe a handful of similar orders. I think previously we have estimated annual XUS Incrilex revenue of 2 to 3 million.

Speaker #5: And that's still the estimate for 2026.

Speaker #7: Thank you.

Chase Knickerbocker: Thank you.

Speaker #1: Thank you. This concludes the question and answer session. Thank you for your participation in today's conference. This is concludes the program. You may now disconnect.

Operator: Thank you. This concludes the question and answer session. Thank you for your participation in today's conference. This concludes the program. You may now disconnect.