Q2 2026 Eton Pharmaceuticals Inc Earnings Call
Speaker #1: Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn the call over to David Krempa, Chief Business Officer at Eton Pharmaceuticals.
Speaker #1: Please proceed.
Speaker #2: Thank you, operator. Good afternoon, everyone, and welcome to Eton's second quarter, 2026, conference call. This afternoon, we issued a press release that outlines the topics we plan to discuss on today's call.
Speaker #2: The release is available on our website, etonpharma.com. Joining me on our call today, we have Sean Brynjelsen, our CEO; Ipek Trinkus, our Chief Commercial Officer; and Judy Matthews, our Chief Financial Officer.
Speaker #2: Before we begin, I would like to remind everyone that today's remarks made during the call may contain forward-looking statements and 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.
Speaker #3: Thank you, David. Good afternoon, everyone, and thank you for joining us today. We had an exceptional second quarter with record revenue, significant margin expansion, and important progress across both our commercial portfolio and pipeline.
Speaker #3: We also completed several strategic transactions that we believe will support Eton's continued long-term growth. I'll begin by highlighting a few of the quarter's key accomplishments.
Speaker #3: We once again achieved record revenue, delivering 99% year-over-year growth with contributions from across the portfolio. At the same time, we delivered significant margin expansion and accelerated adjusted EBITDA and net income growth.
Speaker #3: We established a strong commercial foundation in pediatric dermatology with the successful relaunch of Hemangiol, which is already performing ahead of our expectations. We expanded our portfolio through the acquisition of U.S.
Speaker #3: rights to Inpovito and the licensing of ASN001, adding both a commercial rare disease product and a late-stage development candidate that we believe has the potential to become the largest product in our portfolio.
Speaker #3: And finally, we had a very productive few months on the R&D front. We submitted a PAS—prior approval supplement—for the CANDIVI label expansion, initiated the ET-700 pilot study, began preparations for the Increlex label harmonization study, and also received fast-track designation for Amglidia.
Speaker #3: Starting with the financials, it was another record quarter for Eton. Revenue reached $37.6 million and increased of 99% year over year. Hemangioma had an exceptional relaunch quarter and was the largest contributor to our growth.
Speaker #3: But importantly, the strength was broad-based, with continued momentum across our pediatric endocrinology franchise and Galton. Based on our strong second quarter performance and favorable outlook for the remainder of the year, we are once again raising our 2026 revenue guidance.
Speaker #3: We now expect full-year revenue to exceed $145 million, up from our previous guidance of more than $120 million. Profitability has always been a core focus at Eton, and that was apparent in our results this quarter.
Speaker #3: Adjusted EBITDA increased to $16.2 million, or 43% of revenue, compared with $3.6 million, or 16% of revenue in the prior-year quarter. Even after new incremental expenses related to the ASN001 transaction, which I will discuss in detail shortly, we now expect our full-year adjusted EBITDA margin to exceed 35%.
Speaker #3: Up from our prior guidance of greater than 30%. For the last several years, we've talked about the scalability and operating leverage inherent in our model.
Speaker #3: We're now seeing that play out in the financial results. As we continue to grow revenue, we expect an increasing proportion of that growth to translate into earnings.
Speaker #3: Longer-term, we continue to believe this business can generate an adjusted EBITDA margin above 50%. Turning to our product, dermatology—pediatric dermatology—which has quickly become an important new franchise for Eton.
Speaker #3: We relaunched hemangioma as planned on May 1. And the product is performing ahead of our expectations. Historically, approximately 8,000 patients annually were treated with hemangioma, and the patients accessed the product through 18 different pharmacies when we acquired hemangioma.
Speaker #3: We saw a significant opportunity to streamline and improve that experience by moving patients to a single, high-touch access model through EtonCares. Reducing patient out-of-pocket costs, accelerating access to medication, and providing 24/7 patient support.
Speaker #3: Transitioning an entire patient population to a new distribution model was a significant operational undertaking, particularly given the nature of infantile hemangioma treatment, where therapy typically lasts only about six months.
Speaker #3: We weren't simply transitioning a static patient population; we were simultaneously converting existing patients, onboarding newly diagnosed infants, and supporting patients completing therapy—all while introducing physicians and their office staff to an entirely new access and fulfillment model.
Speaker #3: We originally expected that transition to take three to four months. I'm very proud of our team's execution. By the end of June, we estimate that approximately 95% of patients had transitioned to the new model well ahead of our expectations.
Speaker #3: Critically, this was accomplished while maintaining continuity of care for patients and their families. Today, every hemangioma patient has access to the full EtonCares patient support program.
Speaker #3: Previously, many families were paying approximately $55 per bottle which, in some cases, could total more than $100 per month. Our goal is simple: families dealing with infantile hemangioma shouldn't also have to worry about whether they can afford the medication their child needs.
Speaker #3: With the transition of existing patients largely behind us, our commercial attention is now shifting to the broader opportunity: helping ensure that more infants for whom hemangioma therapy is appropriate receive a therapy specifically developed and approved for infantile hemangioma.
Speaker #3: Instead of relying on off-label adult formulations. Those off-label products were not developed for infantile hemangioma and contained excipients such as alcohol, sugar, and other ingredients that are not appropriate for infants.
Speaker #3: In our conversations with physicians, we've consistently heard that the historical out-of-pocket cost of hemangioma was one factor contributing to off-label prescribing. With EtonCares and our $0 copay program now in place, we believe we've removed an important barrier to broader adoption and are well positioned to drive continued growth.
Speaker #3: We are extremely pleased with the hemangioma acquisition. It has quickly become our largest product and established Eton as a leader in the infantile hemangioma space.
Speaker #3: But as we've spent more time with pediatric dermatologists, vascular anomaly specialists, and families, it's become clear that hemangioma addresses only part of the treatment landscape.
Speaker #3: For severe hemangiomas requiring treatment, hemangioma is the established standard of care, and we estimate that population to be approximately 10 to 15,000 patients annually.
Speaker #3: But infantile hemangiomas affect more than 100,000 patients annually in the United States, and exist across a broad spectrum of severity. This means that a significant number of infants with moderate infantile hemangiomas we estimate 10,000 annually are being treated off-label with ophthalmic timolol because they're simply isn't an FDA-approved topical therapy available.
Speaker #3: These timolol ophthalmic products were developed for glaucoma, not infantile hemangiomas. And present a number of practical limitations including variable dosing, formulation challenges, the absence of FDA-approved labeling, and reimbursement limitations.
Speaker #3: To us, that represented both a clear unmet need and we saw firsthand the evidence that physicians and families are looking for a better option.
Speaker #3: That is what ultimately led us to ASN001, which was specifically developed for infantile hemangiomas and is supported by clinical data. There are several reasons we're particularly excited about ASN001.
Speaker #3: First, the potential patient population could be two to three times larger than hemangioma. Second, ASN001 is expected to be prescribed by the same healthcare professionals as hemangioma, allowing us to leverage our existing commercial infrastructure and the strong relationships we've already been building with thought leaders and vascular anomaly centers.
Speaker #3: And third, as a new product launch, ASN001 would not be subject to certain rebate dynamics that weigh on hemangioma's gross-to-net. As a result, we believe ASN001 will likely have more favorable net pricing economics for Eton.
Speaker #3: Considering those factors together, we believe ASN001 has a clearer path to becoming the target for the largest product in our portfolio. And to be clear, we expect ASN001 to complement hemangioma, rather than compete with it.
Speaker #3: The two products address different segments of the disease spectrum. And together, would allow Eton to support physicians treating infantile hemangiomas across a much broader range of patients.
Speaker #3: With ASN001 in our portfolio, we believe the addressable market could expand to approximately 20 to 30,000 patients annually. From a development standpoint, ASN001 has already completed a phase three trial that showed compelling efficacy compared with placebo.
Speaker #3: Our final remaining development requirement is a bioavailability bridging study, which we plan to initiate in the coming weeks. The proposed study protocol has been reviewed by the FDA and consists of a 24-patient, 29-day study assessing the pharmacokinetics of ASN001.
Speaker #3: And we expect that study to cost approximately $4 million over the next 12 months. Following completion of the study, we expect to be ready to submit the NDA in the second half of 2027, allowing for a potential approval and launch in 2028.
Speaker #3: We believe the ASN001 transaction, together with the hemangioma acquisition earlier this year, demonstrates two defining aspects of Eton's strategy and capabilities. First is our ability to identify and execute highly strategic, potentially transformational transactions.
Speaker #3: At the end of 2024, IncroLex represented a transformational acquisition and became our largest product. Now, in just the last six months, we have acquired and successfully integrated what has become our largest revenue-generating product, while also adding what we believe is now our highest-value pipeline program.
Speaker #3: And we have accomplished both without external financing and while expanding profitability. We believe that combination demonstrates the strength of our business model and our disciplined approach to capital allocation.
Speaker #3: We will continue pursuing commercial and development-stage transactions that we believe can accelerate revenue and earnings growth, and create significant long-term value for our shareholders.
Speaker #3: The second defining capability is what we believe to be one of Eton's greatest competitive advantages: our ability to thoughtfully enter new therapeutic areas and rapidly build leadership positions by leveraging the commercial capabilities we've already established.
Speaker #3: Pediatric dermatology is a great example. We entered the market with hemangioma on May 1st. Just 90 days later, we expanded that franchise with ASN001.
Speaker #3: A product that can leverage the same commercial organization customer relationships and foundational infrastructure. We've successfully executed this playbook before. We entered pediatric endocrinology with Alkindy Sprinkle, and then expanded that platform with three additional high-value commercial products in the specialty.
Speaker #3: Similarly, we entered metabolics with Carglimic acid and subsequently expanded the platform through additional transactions. Importantly, we've been able to build these franchises while continuing to grow our existing portfolio and maintaining discipline around operating expenses.
Speaker #3: We've proven this as a repeatable strategy, and one that Eton is particularly well-positioned to execute. We expect to enter a number of new specialties in the coming years.
Speaker #3: Ultimately, our mission is simple. Bring as many important rare disease therapies to patients as possible. Beyond infantile hemangioma, we've had a number of important developments across our commercial and development stage products.
Speaker #3: We won't have time to cover all of them this afternoon, but I'll highlight several of the most significant. And I'll start with our high-performing pediatric endocrinology portfolio.
Speaker #3: Our adrenal franchise of Alkindy Sprinkle and Kindivy continues to deliver the reliable steady growth we've seen for more than five years. We have now exceeded 600 active patients and continue to grow.
Speaker #3: Last week, we announced that our new Kindivy formulation successfully demonstrated bioequivalence to the reference product Alkindy Sprinkle. As a result, we were able to submit our prior approval supplement, requesting approval of a broader age range.
Speaker #3: Kindivy is currently approved for patients five years of age and older. We continue to believe expanding the label to include patients under five would be an important catalyst for broader adoption and accelerate our path toward our goal of 1,000 active patients.
Speaker #3: We expect the expanded label to be approved in the first half of 2027. We also launched Desmoda at the end of the first quarter, and have been very encouraged by the early response from the endocrinology community, who are glad to have the option of an oral liquid Desmopressin solution to enable individualized dosing.
Speaker #3: Desmopressin dosing can vary significantly from patient to patient and often requires multiple dose adjustments throughout the treatment journey. Desmoda was specifically designed to address that need through precise flexible dosing and that differentiation is resonating strongly with clinicians.
Speaker #3: Beyond the launch itself, Desmoda is also helping us establish relationships with adult endocrinologists, expanding our commercial reach beyond our traditional pediatric call point. We are continuing to invest in peer-to-peer education, engage key opinion leaders, and build awareness through national and regional medical meetings, which include a strong presence at the Endocrine Society annual meeting in June.
Speaker #3: These activities are supporting the Desmoda launch while also strengthening our broader endocrinology platform and creating opportunities across Alkindy Sprinkle, Kindivy, and IncroLex. IncroLex also delivered strong year-over-year revenue growth during the quarter, and we continue to advance our label harmonization study, which we believe could substantially expand the product's long-term market opportunity.
Speaker #3: The FDA has signed off on our study protocol, and we have executed an agreement with a leading CRO to initiate the study. Our team is now actively engaged in study startup activities, with the goal of dosing the first patient by the end of the year.
Speaker #3: Rounding out our pediatric endocrinology portfolio is Anglidia, we recently received fast-track designation from the FDA which is designated or designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.
Speaker #3: Anglidia is a liquid glyburide product used to treat neonatal diabetes and extremely rare condition affecting only a few hundred children in the United States.
Speaker #3: While the product is approved and widely used in Europe, there is currently no approved oral treatment for neonatal diabetes in the United States. We are initiating the product's bioavailability study this month and plan to submit the NDA by the end of the year.
Speaker #3: Allowing for a potential approval and launch in 2027. Given the fast-track designation, we intend to request priority review with our NDA submission. Now, moving on to our Wilson disease franchise, Galzen once again delivered strong revenue growth during the quarter as we continue to convert patients who have historically relied on over-the-counter zinc products.
Speaker #3: Despite the progress we've made since the relaunch, we believe we have converted less than half of the patients currently managed with zinc therapy. That leaves a substantial opportunity for continued growth.
Speaker #3: We're continuing to strengthen the franchise through our strategic partnership with the Wilson disease association deeper engagement with leading centers of excellence and expanded participation at hepatology congresses.
Speaker #3: Combined with the differentiated support offered through Eton Cares, we believe these investments position Galzen well ahead for sustained growth. Longer term, we see an opportunity to further expand our Wilson disease franchise with ET-700, our proprietary, patent-pending, extended-release formulation of zinc acetate.
Speaker #3: Our pilot study is currently ongoing. It is a double-blind placebo-controlled clinical trial involving 36 healthy volunteers. The study will use PET scans with radioactive tracer copper to compare the effects of Galzen ET700 and placebo on intestinal copper absorption.
Speaker #3: We expect initial results in the next month or two with the full study report expected by the end of the year. If successful, the pilot study would support the initiation of a pivotal clinical study in early 2027.
Speaker #3: If ultimately approved, we believe ET700 could potentially exceed 100 million in peak annual US sales. Lastly, I'll finish the portfolio discussion with another recent addition, Implovido.
Speaker #3: Implovido is the only FDA-approved oral therapy for severe forms of Leishmaniasis, a rare but potentially life-threatening parasitic disease that can cause severe skin lesions disfiguring mucosal disease or life-threatening visceral infection.
Speaker #3: As a life-saving treatment for an ultra-rare condition, Implovido was a strong strategic fit for Eton, and we believe patients will benefit from expanded access through our Eton Cares program.
Speaker #3: Eton will also begin distributing the product in the U.S. in late September, and we expect Implovido to be another strong addition to our growing portfolio of orphan therapies.
Speaker #3: At the beginning of this year, we laid out three ambitious long-term goals for Eton. First, to exit 2027 at a 200 million annualized revenue run rate.
Speaker #3: We now believe that Eton is well ahead of this goal. Second, to achieve a 50% adjusted EBITDA margin in 2028. As noted, we have already exceeded 40% in the second quarter this year.
Speaker #3: And third, to reach $500 million in annual revenue by 2030. Clearly, with the addition of ASN001, Eton expects to achieve or exceed this goal.
Speaker #3: Following our first half performance, the successful hemangioma relaunch, the addition of ASN001, and the continued strength of our broader portfolio, we believe we are well positioned to sustain momentum into the future.
Speaker #3: Just as importantly, our recent success has put Eton in an even stronger position to continue pursuing value-creating business development opportunities. Our commercial track record has demonstrated to potential partners that Eton can be an excellent partner for commercializing ultra-rare disease products in the United States.
Speaker #3: And our growing profitability has expanded our financial capacity, allowing us to pursue a broader range of transactions, including potentially larger opportunities. We remain incredibly excited about Eton's future.
Speaker #3: We believe we are still in the early stages of building the leading rare disease company in the United States, and our mission remains unchanged.
Speaker #3: To bring as many important therapies as possible to patients with rare diseases while creating significant long-term value for our shareholders. With that, I'll turn it over to Judy Matthews, our Chief Financial Officer, to discuss our financial results.
Speaker #3: Judy? Thank you, Sean. Second quarter revenue increased 99% to 37.6 million dollars compared to 18.9 million dollars in the second quarter of 2025. Driven by the addition of hemangioma, as well as strong year-over-year growth from Incralex, Alkindi Sprinkle, Kindivi, Galzen, and Carbomic Acid.
Speaker #3: Gross profit for the quarter was 25.4 million dollars compared to 11.9 million dollars in the prior year period. An increase of 113% primarily driven by higher product sales.
Speaker #3: Adjusted gross profit, which excludes the impact of acquired inventory step-up adjustments and intangible amortization, was 27.4 million dollars in the second quarter of 2026, representing an adjusted gross margin of 73%.
Speaker #3: This compares to adjusted gross profit of $14.1 million and adjusted gross margin of 75% in the prior year period. The decrease in adjusted gross margin was primarily attributable to higher Increlex sales outside the US, which generate a negative gross margin.
Speaker #3: We expect full-year adjusted gross margin to exceed 70%, inclusive of a potential commercial milestone expected to be recorded in the fourth quarter of 2026 upon achievement of certain net sales thresholds.
Speaker #3: For Alkindi Sprinkle and Kindivi, R&D expenses for the quarter were $1.0 million compared to $3.7 million in the prior year period. The decrease was primarily due to the Desmoda FDA filing fee incurred in 2025.
Speaker #3: We expect full-year R&D spending to be between $10 million and $14 million, including the $3 million upfront licensing payment for ASN001, which we expect to expense as R&D in the third quarter of 2026.
Speaker #3: General administrative expenses for the quarter were 11.6 million dollars compared to 9.7 million dollars in the prior year period. An increase of 20%. On an adjusted basis, which excludes the impact of share-based compensation, transaction-related costs, and other one-time expenses, G&A expense was 10.2 million dollars compared to 7.6 million dollars in the prior year period.
Speaker #3: The increase was primarily driven by additional headcount to support the growth of our business, with FDA fees accounting for $0.9 million of the year-over-year increase.
Speaker #3: Adjusted EBITDA for the second quarter of 2026 was $16.2 million, or 43% of revenue, compared to $3.1 million, or 16% of revenue, in the prior-year period.
Speaker #3: We expect our full-year adjusted EBITDA margin to exceed 35%, even after the potential commercial milestone referenced above and R&D expenses related to the ASN001 licensing payment and bioavailability study.
Speaker #3: Total company net income was $11.6 million, or $0.35 per diluted share, compared to a net loss of $2.6 million, or $0.10 per basic and diluted share, in the prior year period.
Speaker #3: On a non-gap basis, we reported net income of 14.3 million dollars for the second quarter of 2026, compared to 1.5 million dollars in the prior year period.
Speaker #3: Diluted earnings per share were 43 cents compared to 3 cents per share in the prior year period. Through the second quarter of 2026, we maintained a full valuation allowance against our net deferred tax assets.
Speaker #3: While our operating results have improved significantly, we remained in a cumulative loss position at quarter-end for purposes of our valuation allowance assessment. If we continue to execute against our current forecasts and exit this cumulative loss position during the second half of 2026, we may determine that some or all of the valuation allowance is no longer necessary.
Speaker #3: As of June 30, 2026, our valuation allowance was approximately $22 million. If the valuation allowance is released in a future period, the release would result in a significant one-time non-cash income tax benefit and a corresponding increase in reported GAAP net income in the period in which it is recorded.
Speaker #3: We ended the second quarter with $26.8 million in cash on hand after making a $3 million prepayment on our outstanding debt. We remain in a strong financial position and expect cash generated from operations to grow throughout the second half of the year.
Speaker #3: We will continue to prioritize the use of our cash reserves to fund accretive product acquisitions, while accelerating the repayment of our remaining credit facility over the next 6 to 12 months.
Speaker #3: This concludes our remarks on second quarter results. With that, we'll turn the call back over to the operator for Q&A.
Speaker #1: Thank you. If you'd like to ask a question, please press star one one. If your question has been answered and you'd like to remove yourself from the queue, press star one one again.
Speaker #1: Our first question comes from Chase Nickerbocker with Craig Hallam, your line is open.
Speaker #4: Great. Good afternoon. Thanks for taking the questions and congrats on a really great quarter here. Maybe just first from me on Hemangel.
Speaker #4: Can you give us a sense of what the net realized price is for the quarter, now that we have a couple of months under our belt?
Speaker #4: How's that compare to the to kind of 8 to 10 thousand dollars, you know, per treated patient, you know, for a full course of therapy that you had kind of previously expected?
Speaker #4: And then, if you could give us a sense for volume—you know, we had a sense for the patients that were on drug prior to the purchase.
Speaker #4: Is that pretty comparable in like 95% of of kind of the patients who were on prior were retained and, you know, we should be thinking about that volume kind of going forward?
Speaker #4: Thanks.
Speaker #5: Chase, on the net pricing, we're still sticking with that $8,000 to $10,000 net price on average. We think that's going to be our best estimate.
Speaker #5: You know, it moves around month to month, especially during this transition. Based on patient mix, but we still think it'll be more or less than that 8 to 10 thousand dollar range.
Speaker #5: In terms of patient volume, yes, historically there have been 8,000 patients. We think we've converted all the patients now. We had 95% by the end of June.
Speaker #5: We think we've got them all now. Now, the commercial team's focus is on trying to grow that volume and convert some of the patients that historically have used the off-label adult product.
Speaker #5: So that'll be the game plan going forward.
Speaker #4: Got it. Maybe just to follow up there, there's a kind of a 6-month turnover, obviously, in these patients as they roll off therapy. How can you just speak to kind of the efforts on getting in front of all of those providers under now that the Hemangel is under Eaton ownership and kind of the success of kind of how many of those physicians, those writers that you you know, have been able to to get in front of and and and kind of capture scripts subsequent to the change in ownership?
Speaker #4: And then second, just on ASN001, could you just outline exactly the FDA feedback that your partner got around the bioavailability bridging study? Is that what's going to be considered the registrational study by FDA, or are they taking that clinical study in China into consideration as as supportive evidence?
Speaker #4: Thanks.
Speaker #5: Hi, Chase. I'll take that last question you have, and then Eaton can take the first part. So for ASN001, this is the only study we need to run before we file it.
Speaker #5: The rest of the dossier is largely complete. This is you can think of it almost as a bio it's not exactly a bioequivalency study, but it's a demonstration that our product has you know, absorption characteristics similar to a comparative product that's in the market today.
Speaker #5: And that's basically demonstrating that the absorption and metabolism of the molecule through the body are similar. We view it as very straightforward and low risk.
Speaker #5: We're highly confident that we will be filing that product around the middle of next year. And as we said in our earlier communications, we believe that product will be a very large product for the company, likely.
Speaker #5: It's the largest product.
Speaker #1: Thank you.
Speaker #3: Chase, hi. You said, here for the first part of your question on Hemangeol, I think a few things to note there for the kind of...
Speaker #1: Thank you. Our next question comes from Gary Nachman with Canaccord Genuity. Your line is open.
Speaker #6: Hey, hi. This is Dennis Reznick, author of Gary Nachman. Thanks for taking our questions and congrats on the really strong quarter. So just starting with the recent acquisition of ASN001, just talk a little bit more about the synergies you expect to leverage with the Hemangel franchise and how much of the infrastructure there could help out this product once approved.
Speaker #6: And then on the Impavido acquisition, the product's been available since 2016. So maybe just talk about what you know about the market already, and what you plan to do differently to ensure commercialization and growth, and how big this product could get.
Speaker #6: And then I’ve got one follow-up.
Speaker #1: Ladies and gentlemen, please stand by. Ladies and gentlemen, please stand by. We're experiencing technical difficulties.
Speaker #6: Hello?
Speaker #1: You may begin. Gary, please repeat your question.
Speaker #6: Hey guys, this is Dennis Reznick, author of Gary Nachman. Thanks for taking our question, and congrats on the really strong quarter. So just starting with the recent acquisition of ASN001—can you just talk a little bit more about the synergies you expect to leverage with this and the Hemangeol franchise, and how much of the infrastructure there could help out once this product is approved?
Speaker #6: And then on the recent acquisition of Impavito, you know, the product's been available since 2016. So maybe just talk about what you already know about the market and then what you plan to do differently to ensure commercialization and growth and how big this product can get.
Speaker #6: And I've got one follow-up.
Speaker #5: Sure. So on ASN001, we're very excited about the product. We believe we'll file it in the middle of next year. It'll leverage our existing Hemangel sales team.
Speaker #5: We think this product is ideal fit for the company. It's also a demonstration of our commitment to, you know, really supporting the Hemangel community and the product is expected to be our largest revenue-generating product when we launch it, likely in 2028.
Speaker #5: Regarding Impavito, EPIC, why don't you take that one?
Speaker #3: Sure. So I think, if you look at the previous commercialization before our time, before our acquisition, it was basically distributed by a single-person distributor structure.
Speaker #3: So there was no field sales force on the ground. Actually talking to these infectious disease experts, and specialists. So there are many levers that we are going to pull.
Speaker #3: Also, it wasn't covered traditionally by Medicaid. The distribution was quite dispersed in the sense that it was relatively difficult for patients to figure out what what pharmacy to get the product.
Speaker #3: There was obviously not a copay support in place. So, we think that we are going to pull many of those levers and really bring meaningful value to both the prescribers and the patients.
Speaker #3: It's obvious we already know the targets. It's a very nice fit in terms of a very concentrated target space. It's going to be around 300 sales force targets where very much in a concentrated capacity that's managed the leishmaniasis.
Speaker #3: So we are pretty confident that with our sales force specialist sales force, we are going to get to those infectious disease specialists. Obviously, the guidelines and the therapy profile supports as it is the only FDA-approved product for the therapy and then we are putting it into our Ethan Cares model where these providers and patients will know where to get the product, get the $0 copay support.
Speaker #3: We are obviously going to be able to cover the Medicaid patients that actually need the government coverage and hopefully it will be in a much better place in terms of the patient and provider experience.
Speaker #6: That's super helpful, thank you. And then just on the quarterly results—any more color you can give about how much upside Hemangeol, about how much the Hemangeol launch provided this quarter, and how should we be thinking about sequential growth for that product moving forward?
Speaker #6: And then any call you can give about how the launch of Desmota helped in this quarter particularly. And then and that's where some of my questions.
Speaker #6: Thanks so much.
Speaker #5: Sure. So we're not going to give product-specific guidance, as we haven't done that in the past. But I can tell you that we believe there's significant growth opportunity on Hemangeol.
Speaker #5: This is one where these patient support and the Ethan Cares service adds a lot of value that wasn't there previously and also obviously with the with the much lower copay we think that patients will be less likely to use off-label product and will stay on Hemangel as well as be prescribed it to a greater extent.
Speaker #5: Ultimately, the annual patient number should be exceeding 10,000 a year.
Speaker #6: And regarding your question about the Desmota impact, you know, launch is going well, but from a financial standpoint, it was only its first full quarter on the market.
Speaker #6: So it wasn't a huge contributor to the growth that you saw in Q2. But as we, you know, exit this year, we start expect to start seeing a meaningful contribution from that product that will drive our long-term growth as we get to some of those peak sales numbers we talked about for the product.
Speaker #6: Thanks so much. Congrats on the quarter.
Speaker #5: Thank you.
Speaker #1: Thank you. Our next question comes from Madison Elsadi with B. Raleigh Securities. Your line is open. Madison, if you're muted, please unmute.
Speaker #7: Yes. Thank you. Congrats on the quarter, guys, and thanks for taking the question. So it sounds like much of the Q2 beat here came from Hemangeol.
Speaker #7: How much of the 25 million raised guide is Hemangel versus everything else?
Speaker #5: So, thanks for the question, Madison. As I said previously, in response to a similar question, we're not going to break out our products, as we generally haven't done that in the past. I think that, from a go-forward standpoint, I can say that we expect Hemangeol to continue to grow.
Speaker #5: As was indicated, we've largely completed all the conversions from, you know, the old pharmacies to the new pharmacy system, and so the patient conversion process is complete. We're now looking to grow that business, and it is growing.
Speaker #5: It actually we're really encouraged by the product. We think it's still has a lot of runway. And more importantly, we're super excited about ASN001 late-stage product that will fit in perfectly with our pediatric dermatology sales team.
Speaker #5: And that's a product that's been a patient request and a doctor request for a long time. That will certainly fit well and we hope to launch that in the next whatever 12 to, you know, 20 months.
Speaker #7: Got it. Thank you. And if I may, a quick follow-up. Has your thinking on Desmota peak opportunity has that changed? And now, you know, your sales team you have Kindivi, Incrolyx, multiple you know options in the bag here.
Speaker #7: Kind of, I guess, at what point does the team need to get bigger things?
Speaker #3: Thank you, Madison. I think in terms of the Desmopta peak opportunity at this point, we'll keep it the same with our guidance from the past.
Speaker #3: So I think we said around 40, 40 to 50 as our peak number. So we will still keep it at the same. It's been a very encouraging first five months.
Speaker #3: Actually, in terms of the patient ads, we are over—like, we are around 115% of the target. But again, how fast we are going to get there is too early to tell.
Speaker #3: But the clinician feedback and current patient build has been very much encouraging. So, we'll keep our guidance and the opportunity to the peak size the same.
Speaker #3: In terms of the sales force size, I think at this point, all Kindy and Kindivi being basically adrenal insufficiency franchise. So they're really addressing the same condition.
Speaker #3: So we are approaching that as a portfolio sale. Incrolyx, as you know, is very much ultra-rare specialty sales. And the great thing here is, when you look at the prescribers, obviously they're all endocrinologists, but there's also a very strong, over 90% overlap.
Speaker #3: Even though some endocrinologists are specialists in certain diseases, I think at this point we are not planning any expansion of the sales force.
Speaker #3: We think that our infrastructure is pretty much you know sufficient and effective for the current portfolio.
Speaker #7: Got it. Thank you.
Speaker #1: Thank you. Our next question comes from RK with HC Wainwright. Your line is open.
Speaker #6: Thank you. Good evening, Sean. I'm seeing an excellent quarter. Congratulations on that. I know a lot of my questions have been asked. In in general, it's just trying to understand how you plan on on on having ASN001 and Hemangel work out that franchise especially with Hemangel patent running out in October 28, I believe.
Speaker #6: Is there any way for you to extend that, or is ASN001 the answer for that?
Speaker #5: So thank you for the question. RK, the Hemangel formulation I would say has some aspects which can be improved. And so we're looking at some formulation improvements which we think will be better for the patients and certainly for the caregivers.
Speaker #5: We'll get into that a little later. So there is an opportunity there to add some IP in addition. I would say that for ASN001, that has a very obviously long runway in terms of patent protection.
Speaker #5: That market is several orders larger than Hemangel Hemangel. I'd say that you know look at Hemangel as something that is used to treat the you know severe hemangiomas and ASN001.
Speaker #5: We'll have you know 20 to 30,000 we believe at a minimum number of patients that are actually is you know 200 FDA believes is more than 200,000 patients that have hemangiomas in the United States.
Speaker #5: But we're giving it a nice haircut to make sure that, you know, we're giving it as accurate guidance as we can. But we believe, you know, the number could be significant.
Speaker #5: So that that will certainly be a large product for us. And you know we'll continue to do M&A and licensing and expand our our pediatric pediatric dermatology franchise when we get into a given therapeutic area we continue to invest in it.
Speaker #5: That's for us it's all about the patients. It's about building upon the treatment areas that we're that we get involved in. And it's not a a one product kind of deal.
Speaker #5: We want to continue to build upon that.
Speaker #6: Thanks for that. And then on Hemangel itself, you know in terms of the patient economics, you know you have 8,000 inherited patients. But at this point, how many are paying versus free drug program?
Speaker #6: And in terms of new patient acquisition rate, you know, where are you now since you started on in May? And by the end of 2026, where do you think, you know, realistically could be the paying patient number?
Speaker #5: Hi RK. We're not getting get into the specific breakdown of the payer mix for each patient, but we've said it's more or less coming in as we expected.
Speaker #5: When we put out that 8 to 10,000 net number. So it's more or less in the ballpark. Obviously it jumps around a little bit month to month.
Speaker #5: And the first month or two with some transitions and some bridge product. But it should stabilize here as we go forward.
Speaker #6: Okay. Let me try on Impavido. On that molecule, you know you are—you have 50% to 55% of net sales going to Knight.
Speaker #6: So, how much of a contribution does it make to your EBITDA line, and how much of the demand is there that you're actually handling at this point?
Speaker #5: So we're launching the product at the end of September. So, no financial impact yet, but although there's a larger profit share—I mean, it was a little bit of a unique model.
Speaker #5: We paid very little upfront, so we think it's still going to be a very attractive deal for the company. We think it could contribute multiple millions of dollars annually, with very little upfront and very little resource distraction.
Speaker #5: And it’s a good complementary fit with the rare disease strategy and the Evincares program. So, it will be lower margin than some of our other products, but we think it’ll still be an attractive opportunity and a very attractive return on investment relative to what we put up to get the distribution rights.
Speaker #6: Thank you. Thanks for taking my questions.
