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Date

Thursday, May 14, 2026 at 4:30 p.m. ET

Call participants

  • Chief Executive Officer — Sean Brynjelsen
  • Chief Financial Officer — James Gruber
  • Chief Commercial Officer — Ipek Erdogan-Trinkaus
  • Executive Vice President of Accounting and Finance — Judy Matthews

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Takeaways

  • Revenue -- $24.3 million for the quarter, up 40% compared to $17.3 million in the prior year, excluding $3.3 million in prior-year licensing revenue.
  • Product Sales and Royalty Revenue -- $24.3 million, representing 73% growth, driven by INCRELEX, ALKINDI SPRINKLE, GALZIN, Carglumic Acid, and contributions from KHINDIVI.
  • Gross Profit -- $14.7 million, a 49% increase, attributed mainly to increased product sales.
  • Adjusted Gross Profit -- $16.2 million (67% margin), versus $12.0 million (69% margin) year over year; inclusion of INCRELEX sales outside the U.S. diluted margin.
  • Full-Year Revenue Guidance -- Raised from $110 million to over $120 million due to Q1 results and positive trends into mid-Q2.
  • R&D Expense -- $1.9 million, up from $1.2 million, reflecting higher clinical study expenditures for KHINDIVI and ET-700.
  • G&A Expense -- $10.4 million GAAP (14% increase) or $9.0 million non-GAAP (22% increase), with $0.9 million rise in FDA program fees after losing the orphan PDUFA exemption.
  • Adjusted EBITDA -- $5.7 million or 24% of revenue, up from $3.7 million (21% margin) last year when licensing revenue benefited the figure.
  • Net Income -- $1.6 million, reversing a $1.6 million loss; non-GAAP net income was $4.5 million with a $0.14 diluted EPS (up from $0.07).
  • Cash Flow and Balance Sheet -- $7.4 million in cash flow from operations; $19.7 million cash on hand after paying $14 million for HEMANGEOL.
  • Credit Facility Update -- Interest rate on the $30 million facility reduced by approximately 200 basis points at no cost and without maturity extension.
  • HEMANGEOL Launch and Pricing -- Launch completed in May; preliminary estimate is average net price per full therapy course of around $8,000–$10,000, with around 60%–65% of patient volume that may be near-zero revenue.
  • DESMODA Launch -- Initiated in March as the only FDA-approved desmopressin oral solution; management projects peak sales of $30 million–$50 million with positive launch feedback.
  • Portfolio Performance -- INCRELEX, ALKINDI SPRINKLE, and GALZIN continued major growth, with runway remaining for all three products.
  • INCRELEX Label Harmonization -- FDA cleared the label harmonization clinical study to proceed; study to start in H2 and track 30 patients for up to 5 years with an annualized growth endpoint at 12 months.
  • ET-700 Pilot Study Initiated -- A double-blind study of ET-700 versus GALZIN and placebo is underway, with top-line results expected in H2 2026, potentially leading to a pivotal trial in early 2027.
  • KHINDIVI Label Expansion -- Bioequivalency study in final dosing, with results due within months; if positive, a supplemental filing is planned in Q3 with possible approval in Q2 2027.
  • Amglidia Program -- IND filed for oral liquid glyburide; bioavailability study initiation by July and NDA targeted for Q4, aiming for U.S. launch in 2027.
  • Long-Term Targets -- Management reiterated goals to exceed $200 million annual revenue by 2027, achieve 50% adjusted EBITDA margin by 2028, and reach $500 million annual revenue by 2030.

Summary

Management reported the launch of two major products, HEMANGEOL and DESMODA, which are expected to diversify the portfolio and position the company in pediatric dermatology. The specialty distribution transition for HEMANGEOL involved consolidating prescriptions from 17 prior pharmacies, with approximately 60% of patient volume involving prior pharmacy collaboration. Out-of-U.S. INCRELEX sales were low single-digit millions with a cost-of-goods ratio of 2:1, diluting overall gross margin, and total annual ex-U.S. INCRELEX sales are projected at $2 million–$3 million for 2026.

  • Chief Commercial Officer Ipek Erdogan-Trinkaus said, "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."
  • Adjusted gross profit margin is expected to recover to at least 70% for the full year as lower-margin items subside.
  • Specialty pharmacy Anovo currently manages the entire portfolio's distribution, with scalability plans contingent on necessity.
  • The recently amended credit facility provides cost savings without restricting future financing options for acquisitions.
  • Amglidia addresses a rare disease without FDA-approved alternatives, and approval would build upon the company’s pediatric endocrinology specialization.

Industry glossary

  • Orphan PDUFA Exemption: FDA program exemption that waives certain Prescription Drug User Fee Act (PDUFA) fees for companies with qualifying rare disease products below a specified revenue threshold.
  • Label Harmonization: The process of aligning a drug's approved uses and definitions with international standards, particularly between U.S. and European regulatory agencies.
  • Specialty Pharmacy: Pharmacies focused on distributing and supporting complex, high-cost medications for rare or chronic conditions, often requiring coordinated care and high-touch patient support.
  • Adjusted Gross Profit: Gross profit figure that has been recalculated to exclude non-recurring items such as inventory step-up adjustments and amortization of acquired intangibles, providing a clearer picture of underlying profitability.

Full Conference Call Transcript

Sean Brynjelsen: 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. We launched 2 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 quarter 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, GALZIN and Carglumic 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 DESMODA and HEMANGEOL since they launched in mid-March and May, respectively. 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. 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.

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. 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 2 new products in 2026 so far without a significant increase in expenses and without impacting the execution of growth in our existing portfolio. 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 noncancerous 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. 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.

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's journey.

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 co-pay support for commercially insured patients and expanded patient assistance 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 co-pay support and financial assistance was often fragmented and difficult for offices and families to navigate.

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. And lastly, we are actively engaging with the patient advocacy community around HEMANGEOL and are increasing our investment in 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. 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, one, the fact that the adult product had a lower co-pay than the $55 HEMANGEOL co-pay; and two, 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 co-pay issue with our $0 co-pay program, and we plan to address the awareness issue through our investments and efforts in new campaigns targeted at both prescribers and caregivers. 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% of the volume may be near 0 revenue, which should result in an estimated average net price per patient of around $8,000 to $10,000 for a 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.

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, but we have experienced cooperation from certain prior dispensing pharmacies, which we believe will help the situation in the transition. HEMANGEOL's revenue contribution to second quarter results is expected to be limited. Since it is launching mid-quarter, 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 HEMANGEOL could be our largest product in 2027. Eton also launched DESMODA during the first quarter, 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 with -- in the same patient over time throughout their treatment journey. Historically, patients and providers have often had reliance 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 shared 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 teams' exceptional launch plan and execution, and I believe that it was the best executed product launch in Eton's history and sets a new standard for future product launches. Since day 1 of the launch, peer-to-peer education efforts have complemented targeted field engagement across key accounts supporting early awareness and clinical dialogue. In parallel, Eton has had strong opportunities to engage with thought leaders at national and regional conferences. Earlier this month, our team attended 2 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 of 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. 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 million 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 3 of these key growth products.

So we continue to believe that they have long runways for growth ahead of them. 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 the second half 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 U.S. definition of severe primary IGF-1 deficiency to match that of Europe. If we are successful with harmonizing the label, we believe the INCRELEX market opportunity could increase fivefold 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 3 times daily, ET-700 taken twice daily plus a placebo taken daily as well.

And a placebo also, I'm sorry, taken 3 times daily. The study treatment will last 4 weeks, and we expect to have the top line results in the second half of 2026. 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 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 the third quarter and potentially receive approval in the second quarter of 2027. We have continued to see tepid uptake of KHINDIVI with its current restrictive label and believe the extended 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. 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. 2 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 the fourth quarter, 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. The momentum from our existing products remains strong.

We've added 2 additional high-value product launches. We're meaningfully adding and 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. Based on the strong performance in Q1, I believe we remain on track to reach the following forward long-term goals I outlined in March. Number one, build the largest rare disease portfolio in the United States. 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.

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 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 June 1, 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. 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. James?

James Gruber: 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. 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.

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 compared to adjusted gross profit of $12.0 million and 69% of revenue in the prior year period. First quarter of 2026 included revenue from INCRELEX sales outside the U.S., 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.

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, 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 onetime expenses, G&A expense was $9.0 million compared to $7.3 million in the prior year period.

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 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. Our adjusted EBITDA will likely see fluctuations quarter-to-quarter depending on the timing of R&D expenses and ex U.S.

INCRELEX orders, but we expect the full year adjusted EBITDA margin to be above 30%. 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 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.

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.

In addition, 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. Before we conclude, I'd like to express my sincere gratitude to Sean, 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 first quarter results. And with that, we'll turn it back over to the operator for Q&A.

Operator: [Operator Instructions] And our first question comes from the line of Madison El-Saadi of B. Riley Securities.

Madison Wynne El-Saadi: Congrats on the quarter. And James, congrats on all the success here at Eton and wishing you the best of luck. So when we look at the product-level dollar contribution behind your $10 million guide, maybe just walk us through that. And we should probably assume this is 4Q loaded. And then 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 had it set at? I'm guessing this captures a typical 6-month course. And then if you could, any clarity into the proportion of the 8,000 patients that are retaining coverage at this new list price?

And maybe since it's still pretty early, if you could just talk about kind of your expectations for that going forward?

David Krempa: 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 insights of what we thought we could do this year 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. We're happy with the DESMODA launch. So 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.

We walked through -- roughly 60% to 65% of the patients will likely be non-revenue-generating or very low revenue-generating, but it should average out to around that $8,000 to $10,000 net price per patient. And 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 had very good coverage on our products. So we expect that to continue, but too early in the launch to make any statements about that.

Operator: Our next question comes from the line of Charles Wallace of H.C. Wainwright.

Charles Wallace: This is Charles on for RK from H.C. Wainwright. So for my first question, something kind of struck me on the call, you said that HEMANGEOL 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 for my first question?

Sean Brynjelsen: This is Sean. We have indicated INCRELEX is our current largest product that continues to grow as well. With HEMANGEOL, we have obviously big expectations for it. We've transferred a large number of the patients over to -- and we're continuing that transfer process. We'll provide a little bit more color, I would imagine, on future calls. 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, but we've spoken descriptively of it. And I think we'll certainly do that and revise our guidance as it transpires.

Charles Wallace: And I guess for my second question from me, so 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?

Sean Brynjelsen: Yes. 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. We're very pleased with INCRELEX's performance. We have patients. It's been a great product. And it's the reason why it's our largest. We are also looking at initiating that label expansion study. 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 being able to file that label update.

Charles Wallace: And sorry, one more question, if I may. So I was just curious if -- as you're acquiring all these products, is it 1 specialty pharmacy that's handling all these drugs in the distribution?

Sean Brynjelsen: 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. But we are -- we do have aspirations to have the largest rare disease portfolio in the industry. And if ever comes a point where we think we need to add another specialty pharmacy, we'll do that. But for right now, we're very pleased with Anovo and the work that they do.

Operator: Our next question comes from the line of Chase Knickerbocker of Craig-Hallum.

Chase Knickerbocker: 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? Or what else drove it as far as how your assumptions changed from March to now?

Sean Brynjelsen: Sure. So 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. And as we're going into -- in the past few weeks, we see that momentum continue. Really across the board, we've been kind of hitting our numbers that we expect. And 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 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. We've given off that guidance of $30 million to $50 million. We'll update that, I imagine, on our -- on future calls. And we'll see how -- but all of that kind of came together. And we said more than $120 million. So obviously, it's more than $120 million. We don't -- we'll leave it at that, and we'll see what happens.

Chase Knickerbocker: Helpful. And maybe if I can draw some cross-currents between kind of your experiences with GALZIN and HEMANGEOL here. I mean you guys did a pretty good job of switching those patients pretty quickly into your distribution platform. I mean maybe talk about some of the learnings that you had from GALZIN 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? Because again, we did outperform on GALZIN. So maybe just kind of talk about if that's a fair comparison and just some of your learnings.

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

Ipek Erdogan-Trinkaus: Thank you for the question. That is actually a great parallel, Few things that are very similar and a few things that are different. I think with GALZIN, it was all open network. It was multiple pharmacies. We actually -- we 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. 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 GALZIN. I think we already shared before, we are already over those numbers.

We are about 300 patients already within the course of the 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 them from some local small pharmacies, some big pharmacies like Walgreens, so 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, our 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. So that's because we have 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 is 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 have never been on GALZIN on the competitive over-the-counter non-Rx therapies. So that's the goal right now of that conversion.

But 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.

Chase Knickerbocker: Helpful color. 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 INCRELEX in the quarter, if you could share that. And then just what the associated COGS was of that? And certainly wish you all the best in your next endeavors, and it's been a pleasure working with you.

James Gruber: Likewise. Thanks, Chase. So we have -- as far as the diluted margin profile on our ex U.S. INCRELEX revenue, it's about 2:1. So $2 of COGS to $1 of revenue. 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 ex U.S. INCRELEX revenue of $2 million to $3 million, and that's still the estimate for 2026.

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