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Investor releaseQuarter not tagged2026-05-16Eton (ETON) Q1 2026 Earnings Call Transcript
Motley Fool
Eton (ETON) Q1 2026 Earnings Call Transcript
Image source: The Motley Fool. Thursday, May 14, 2026 at 4:30 p.m. ET 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 Need a quote from a Motley Fool analyst? Email [email protected] 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 n...
Investor releaseQuarter not tagged2026-05-15Eton Pharmaceuticals, Inc. (ETON) Misses Q1 Earnings Estimates
Zacks
Eton Pharmaceuticals, Inc. (ETON) Misses Q1 Earnings Estimates
Eton Pharmaceuticals, Inc. (ETON) came out with quarterly earnings of $0.05 per share, missing the Zacks Consensus Estimate of $0.1 per share. This compares to earnings of $0.07 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -50.00%. A quarter ago, it was expected that this company would post earnings of $0.12 per share when it actually produced earnings of $0.05, delivering a surprise of -58.33%. Over the last four quarters, the company has not been able to surpass consensus EPS estimates. Eton Pharmaceuticals, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $24.27 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 8.48%. This compares to year-ago revenues of $17.28 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Eton Pharmaceuticals shares have added about 82.3% since the beginning of the year versus the S&P 500's gain of 8.8%. While Eton Pharmaceuticals has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Eton Pharmaceuticals was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. Yo...
Investor releaseQuarter not tagged2026-05-15Eton Pharmaceuticals, Inc. Q1 2026 Earnings Call Summary
Moby
Eton Pharmaceuticals, Inc. Q1 2026 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved 73% year-over-year product revenue growth driven by the core rare disease portfolio, including INCRELEX, ALKINDI, and GALZIN, demonstrating the durability of the existing commercial base. Successfully launched DESMODA and HEMANGEOL in the first half of 2026, expanding the company's footprint into pediatric dermatology and endocrinology without significant increases in discretionary G&A. Management attributes the scalable margin expansion to a nimble rare disease infrastructure that allows for multiple product launches on a shared commercial platform. Strategic focus for HEMANGEOL involves transitioning 8,000 patients from a fragmented 17-pharmacy network to a single specialty pharmacy to improve visibility and patient support. The company is addressing historical off-label usage of adult propranolol by eliminating patient co-pays and educating prescribers on the risks of alcohol and sugar excipients in non-pediatric formulations. Performance in the first quarter was achieved in a highly profitable manner, with product revenue growth significantly outstripping the 14% GAAP G&A increase. Raised full-year 2026 revenue guidance to exceed $120 million, up from $110 million, based on strong Q1 trends and the anticipated contribution of new launches. Expects to reach a 50% adjusted EBITDA margin by 2028 and a $500 million annual revenue target by 2030 through organic growth and accretive acquisitions. Anticipates a fivefold increase in the INCRELEX market opportunity if the upcoming label harmonization study successfully aligns U.S. diagnostic criteria with European standards. Guidance for HEMANGEOL assumes a sizable revenue contribution starting in Q3 2026, with the product potentially becoming the company's largest revenue driver by 2027. Plans to submit an NDA for Amglidia in Q4 2026, targeting a high-value launch in 2027 for the treatment of neonatal diabetes. G&A expenses were impacted by $0.9 million in new FDA annual program fees as the company no longer qualifies for the orphan PDUFA exemption due to exceeding revenue thresholds. Amended a $30 million credit facility to lower the interest rate by approximately 200 basis points at no additional cost to the company. Reported that 60% to 65% of HEMANG...
Investor releaseQuarter not tagged2026-05-15Eton Pharmaceuticals Reports First Quarter 2026 Financial Results
GlobeNewswire
Eton Pharmaceuticals Reports First Quarter 2026 Financial Results
Q1 2026 product sales of $24.3 million, representing 73% growth over Q1 2025 Raising full year revenue guidance - now expect 2026 revenue to exceed $120 million, up from previous guidance of $110 million Q1 2026 fully diluted GAAP EPS of $0.05, non-GAAP fully diluted EPS of $0.14, and Adjusted EBITDA of $5.7 million Received FDA approval for and launched DESMODA™ Acquired and relaunched HEMANGEOL® Announced initiation of ET-700 clinical study, the Company’s extended-release formulation of zinc acetate Received FDA clearance to proceed on INCRELEX® label harmonization study Management to hold conference call today at 4:30pm ET DEER PARK, Ill., May 14, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the quarter ended March 31, 2026. “With record Q1 products sales and two major product launches already underway this year, Eton is off to a terrific start in 2026. Based on this strong year-to-date performance, we are raising our full year 2026 revenue guidance. We now expect more than $120 million of revenue, up from our prior guidance of $110 million,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “First quarter product sales grew 73% year over year, with strong growth contributions from across the portfolio, including INCRELEX, ALKINDI SPRINKLE®, GALZIN® and Carglumic Acid. In March, we launched DESMODA, the first and only FDA-approved oral desmopressin solution. Our commercial team has seen high levels of interest from the healthcare provider and patient advocacy communities, and we are encouraged by the initial uptake of the product. In addition, on May 1, we relaunched HEMANGEOL, ensuring optimized access and rare-disease centric support to an important, time-sensitive therapy. While we are early in its commercialization, transitioning patients and providers appears to be progressing well, and we’re excited that parents now have access to an FDA-approved treatment backed by our world-class Eton Cares support program. Both new product launches are expected to contribute significantly to revenue growth in 2026, 2027, and beyond.” “We have also made tremendous progress with the R&D programs in our pipeline. We initiated a clinical study for the KHINDIVITM label expansi...
Investor releaseQuarter not tagged2026-05-15Eton Pharmaceuticals Q1 Earnings Call Highlights
MarketBeat
Eton Pharmaceuticals Q1 Earnings Call Highlights
Interested in Eton Pharmaceuticals, Inc.? Here are five stocks we like better. Eton Pharmaceuticals raised its 2026 revenue guidance to more than $120 million from $110 million after reporting record first-quarter product sales and strong momentum across its existing portfolio. Q1 revenue rose 40% to $24.3 million, and the company posted net income of $1.6 million versus a loss a year ago. New launches are gaining traction, especially HEMANGEOL and DESMODA. Eton said HEMANGEOL should contribute more meaningfully starting in Q3 and could become its largest product by 2027, while DESMODA has received very positive early prescriber feedback and could reach peak sales of $30 million to $50 million. Pipeline and financial flexibility remain important themes. The company advanced several programs, including INCRELEX label harmonization, ET-700, KHINDIVI expansion and Amglidia, while also improving its credit facility and ending the quarter with $19.7 million in cash. Eton Pharmaceuticals (NASDAQ:ETON) raised its 2026 revenue outlook after reporting record first-quarter product sales and highlighting early progress from two recent product launches, DESMODA and HEMANGEOL. Chief Executive Officer Sean Brynjelsen said the company now expects full-year revenue to exceed $120 million, up from prior guidance of $110 million. He attributed the higher outlook to first-quarter outperformance, continued portfolio momentum midway through the second quarter, and greater confidence in the HEMANGEOL launch. → Micron Investors Face a High-Stakes Moment After the Latest Rally “The first quarter was another great quarter for Eton,” Brynjelsen said, citing 73% year-over-year growth in product revenue. He said the quarter’s growth was driven by contributions from INCRELEX, ALKINDI, Galzin and carglumic acid, and did not include meaningful benefit from DESMODA or HEMANGEOL, which launched in mid-March and May, respectively. Chief Financial Officer James Gruber said total first-quarter revenue increased 40% to $24.3 million from $17.3 million a year earlier. Product sales and royalty revenue rose 73% to $24.3 million from $14.0 million in the prior-year period. The first quarter of 2025 included $3.3 million of licensing revenue. → How Bad Could Tesla’s Cybertruck Recall Be for Shares? Gross profit rose 49% to $14.7 million from $9.9 million. Adjusted gross profit was $16.2 million, or...
Investor releaseQuarter not tagged2026-05-15Eton Pharmaceuticals Inc (ETON) Q1 2026 Earnings Call Highlights: Record Sales and Strategic ...
GuruFocus.com
Eton Pharmaceuticals Inc (ETON) Q1 2026 Earnings Call Highlights: Record Sales and Strategic ...
This article first appeared on GuruFocus. Release Date: May 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Eton Pharmaceuticals Inc (NASDAQ:ETON) achieved record product sales with a 73% year-over-year growth in product revenue. The company launched two new major products, Desmoda and Hemangio, which are expected to contribute significantly to future revenue. Eton Pharmaceuticals Inc (NASDAQ:ETON) raised its full-year revenue guidance to exceed $120 million, up from the previous guidance of $110 million. The company maintained a strong adjusted EBITDA margin of 24% for the quarter and expects to achieve a greater than 30% margin for the full year. Eton Pharmaceuticals Inc (NASDAQ:ETON) is advancing its R&D pipeline with several development milestones, including FDA clearance for a new clinical study and progress on multiple product development programs. The launch of Hemangio is expected to have limited revenue contribution in the second quarter due to the mid-quarter launch and patient transfer complexities. Approximately 60% to 65% of Hemangio's volume may be near zero revenue due to patient assistance programs and inherited payer contracts. General and administrative expenses increased by 14% year-over-year, primarily due to higher FDA annual program fees. The company faces challenges in transitioning thousands of patients to a new single pharmacy for Hemangio, which could impact the speed of revenue realization. Eton Pharmaceuticals Inc (NASDAQ:ETON) no longer qualifies for the orphan-PDUFA exemption, leading to increased costs. Warning! GuruFocus has detected 5 Warning Sign with ETON. Is ETON fairly valued? Test your thesis with our free DCF calculator. Q: Can you explain the factors behind the increased revenue guidance and how Hemangio's pricing compares to previous levels? A: The increase in guidance is largely due to the Hemangio launch and strong performance across our portfolio. We expect Hemangio to net more than previously, with an estimated net price per patient of $8,000 to $10,000. However, it's early in the launch, and we expect good coverage to continue. - David Krampa, Chief Business Officer Q: What is currently Eaton's largest product, and how does Hemangio's potential compare? A: Increlex is currently our largest product, and we have high expectations for Hemangio. We are in...
TranscriptFY2026 Q12026-05-14FY2026 Q1 earnings call transcript
Earnings source - 62 paragraphs
FY2026 Q1 earnings call transcript
Good afternoon, and welcome to the Eton Pharmaceuticals first quarter 2026 financial results conference call. At this time, all participants are 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.
Thank you, operator. Good afternoon, everyone, and welcome to Eton'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. 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 M. 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 [email protected]. 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.
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.
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 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. 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 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 zero-dollar co-pay 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 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. 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. 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 using off-label adult product were, 1, the fact that the adult product had a lower co-pay than the $55 HEMANGEOL co-pay, 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 co-pay issue with our $0 co-pay program. 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.
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%-65% of the volume may be near zero revenue, which should result in an estimated average net price per patient of around $8,000-$10,000 for full course of therapy. 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 and the transition. HEMANGEOL'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.
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 1st quarter, shortly after its FDA approval. As the 1st 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.
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, I shared that I was encouraged by what I saw. 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, 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 one of the launch, peer-to-peer education efforts have complemented targeted field engagement across key accounts, supporting early awareness and clinical dialogue.
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. 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 can 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-$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.
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-I deficiency to match that of Europe.
If we are successful with harmonizing the label, we believe the INCRELEX market opportunity could increase five-fold in the U.S. 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. 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 U.S. 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 bioequivalence 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 3rd quarter and potentially receive approval in the 2nd 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, it's not been approved in the U.S. Currently, there are no FDA-approved treatments for neonatal diabetes, 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 U.S., 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 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, 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. 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 4 long-term goals I outlined in March. Number 1, build the largest rare disease portfolio in the United States. 2, reach a $200 million annual revenue run rate by end of 2027. 3, achieve a 50% adjusted EBITDA margin profile in 2028. 4th, 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, 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. We're excited to have her on board. With that, I'll turn it over to James to discuss the financial results. James?
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 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.
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. 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 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 first quarter results, and with that, we'll turn it back over to the operator for Q&A.
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 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 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.
All right. Thanks for taking our question, and congrats on the quarter. James, congrats on all the success here at Eton, and wishing you the best of luck.
Thanks, Madison.
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 4Q loaded. Secondly, regarding the HEMANGEOL price, maybe walk us through the $8K 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. If you could, any clarity into the proportion of the 8,000 branded patients that are retaining coverage at this new list price. Maybe since it's still pretty early, you could just talk about kind of your expectations for that going forward. Thanks.
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 to 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.
We walked through roughly 60%-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-$10,000 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. 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, so we expect that to continue. Too early in the launch to make any statements about that.
Understood. Thank you all.
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.
Hi. Thanks for taking my question. This is Charles Wallace. 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.
Hi, Charles, this is Sean. We have indicated ALKINDI SPRINKLE 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, too, and 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.
We've spoken descriptively of it, and I think we'll certainly do that and revise our guidance, as it transpires.
Great. For my second question, if I may. Where are you currently with the patient number for INCRELEX, and are you confident with the 120 patients at the end of the year?
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 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.
Sorry, one more question, if I may. I was just curious if, you know, after acquiring all these products, is it one specialty pharmacy that's handling all these drugs in the distribution?
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, we're very happy with them. We are, we do have aspirations to have the largest rare disease portfolio in industry. 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 Inova and the work that they do.
Great. Thank you so much for taking the questions.
Pleasure.
Thank you. One moment for our next question. Our next question comes the line of Chase Knickerbocker of Craig-Hallum. Your line is now open.
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 or, you know, what else, what else drove it as far as how your assumptions changed from March to now? Thanks.
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. 2, 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 3rd 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 out that guidance of 30 to 50. We'll, we'll update that, I imagine, on our, on future calls and, you know, we'll see how. All of that kinda came together. We said more than 120, obviously it's more than 120. We'll leave it at that, and, we'll see what happens.
Helpful. maybe if I can draw some crosscurrents between kind of your experiences with Galzin and, you know, 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, you know, potential, you know, the potential for any sort of opportunity to do a little bit better than you guys are expecting as far as kind of switching of those patients into your platform. Because again, we outperform on Galzin. maybe just kind of talk about if that's a fair comparison and just some of your learnings.
Sure. Chase, I'm gonna turn that question over to our Chief Commercial Officer, Ipek. Ipek?
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, and 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.
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, this is also 8,000 patients. It's a big, much bigger, existing base of active patients. 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 Inova Specialty Pharmacy pulling those transfers through, which has been very good. Almost 60% of that 8,000 base was that we were able to actually put some sort of a collaboration with the former pharmacies to agree to transfer the patients.
That's because like 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.
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.
Likewise. Thanks, Chase. We have, as far as the diluted margin profile on our ex-U.S. INCRELEX revenue, it's about 2 to 1, 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-U.S. INCRELEX revenue of $2 million-$3 million, that's still the estimate for 2026.
Thank you.
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.
Investor releaseQuarter not tagged2026-05-08Apellis Pharmaceuticals, Inc. (APLS) Tops Q1 Earnings and Revenue Estimates
Zacks
Apellis Pharmaceuticals, Inc. (APLS) Tops Q1 Earnings and Revenue Estimates
Apellis Pharmaceuticals, Inc. (APLS) came out with quarterly earnings of $0.15 per share, beating the Zacks Consensus Estimate of a loss of $0.38 per share. This compares to a loss of $0.74 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +139.30%. A quarter ago, it was expected that this company would post a loss of $0.39 per share when it actually produced a loss of $0.47, delivering a surprise of -20.51%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Apellis Pharmaceuticals, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $268.3 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 33.65%. This compares to year-ago revenues of $166.8 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Apellis Pharmaceuticals shares have added about 63.7% since the beginning of the year versus the S&P 500's gain of 7.6%. While Apellis Pharmaceuticals has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Apellis Pharmaceuticals was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in...
Investor releaseQuarter not tagged2026-05-05Eton Pharmaceuticals to Report First Quarter 2026 Financial Results on Thursday, May 14, 2026
GlobeNewswire
Eton Pharmaceuticals to Report First Quarter 2026 Financial Results on Thursday, May 14, 2026
DEER PARK, Ill., May 04, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report first quarter 2026 financial results on Thursday, May 14, 2026. Management will host a conference call and live audio webcast to discuss the results at 4:30 p.m. ET (3:30 p.m. CT). In addition to taking live questions from participants on the conference call, management will be answering emailed questions from investors. Investors can email questions to: [email protected]. The live webcast can also be accessed on the Investors section of Eton’s website at https://ir.etonpharma.com/. An archived webcast will be available on Eton’s website approximately two hours after the completion of the event and for 30 days thereafter. About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has ten commercial rare disease products: KHINDIVITM, INCRELEX®, ALKINDI SPRINKLE®, DESMODA™, GALZIN®, HEMANGEOL®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com. Investor Relations: Lisa M. Wilson In-Site Communications, Inc. T: 212-452-2793 E: [email protected] Source: Eton Pharmaceuticals, Inc.
Investor releaseQuarter not tagged2026-03-20Eton Pharmaceuticals, Inc. (ETON) Q4 Earnings Lag Estimates
Zacks
Eton Pharmaceuticals, Inc. (ETON) Q4 Earnings Lag Estimates
Eton Pharmaceuticals, Inc. (ETON) came out with quarterly earnings of $0.05 per share, missing the Zacks Consensus Estimate of $0.12 per share. This compares to a loss of $0.02 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -58.33%. A quarter ago, it was expected that this company would post earnings of $0.13 per share when it actually produced a loss of $0.07, delivering a surprise of -153.85%. Over the last four quarters, the company has not been able to surpass consensus EPS estimates. Eton Pharmaceuticals, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $21.28 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 4.22%. This compares to year-ago revenues of $11.65 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Eton Pharmaceuticals shares have added about 12.5% since the beginning of the year versus the S&P 500's decline of 3.2%. While Eton Pharmaceuticals has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Eton Pharmaceuticals was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future...
Investor releaseQuarter not tagged2026-03-20Eton Pharmaceuticals Q4 Non-GAAP Earnings, Revenue Rise
MT Newswires
Eton Pharmaceuticals Q4 Non-GAAP Earnings, Revenue Rise
Eton Pharmaceuticals (ETON) reported Q4 non-GAAP earnings late Thursday of $0.19 per diluted share,
Investor releaseQuarter not tagged2026-03-20Eton Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results
GlobeNewswire
Eton Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results
Q4 2025 product sales of $21.3 million, representing 83% growth over Q4 2024 Q4 2025 basic GAAP EPS of $0.06, fully diluted GAAP EPS of $0.05, basic non-GAAP EPS of $0.21, fully diluted non-GAAP EPS of $0.19, and Adjusted EBITDA of $6.2 million Launched DESMODA™, the first and only FDA-approved desmopressin oral solution Licensed U.S. rights to Orphan Drug HEMANGEOL®; expected to be accretive to 2026 earnings Company expects full year 2026 revenue to exceed $110 million with an Adjusted EBITDA margin of over 30% Management to hold conference call today at 4:30pm ET DEER PARK, Ill., March 19, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the quarter ended December 31, 2025. “It was another phenomenal quarter for Eton with meaningful contributions from key products across our portfolio including INCRELEX, ALKINDI SPRINKLE, KHINDIVI, and GALZIN. The strong fourth quarter helped us cap off a transformational 2025. During the year we launched three major products, INCRELEX, GALZIN, and KHINDIVI, and delivered $80 million in total revenue, more than doubling our 2024 revenue,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “The recent FDA approval of DESMODA and the acquisition of HEMANGEOL have further accelerated our 2026 growth trajectory. DESMODA’s approval was highly anticipated by the endocrinology community, and the product received a very strong reception in its first week of launch. Our commercial team is fired up and fully mobilized, executing on the launch plan. Our entire team is also hard at work on the integration of HEMANGEOL and eager for our scheduled May 1st relaunch. Both of these products will be key growth contributors in 2026 and beyond. In addition, this year is poised to be our most active year yet on the clinical front, with key studies initiating or already initiated for the INCRELEX label expansion, the KHINDIVI reformulation, ET-700, and AMGLIDIA.” “We are poised for another year of record financial results in 2026. For the full year, we expect to see revenue exceed $110 million and at least a 30% Adjusted EBITDA margin,” concluded Brynjelsen. Fourth Quarter and Recent Business Highlights 83% growth in product sales year-over-year. Eton report...

