Sean Brynjelsen
Analyst · Craig-Hallum
Thank you, David. Good afternoon, everyone, and thank you for joining us today. It was another outstanding quarter for Eton with record revenue, significant margin expansion and strong cash flow generation. We continue to fire on all cylinders on both the commercial and development fronts. Revenue grew a remarkable 158% year-over-year, reaching $57.9 million in the quarter. The third quarter was the first with a full quarter of HEMANGEOL revenue, which was a significant growth driver, but we also saw strength across all our key products. In fact, we hit record high levels of active patient counts in the quarter on all of our key branded products, including INCRELEX, HEMANGEOL, ALKINDI SPRINKLE, KHINDIVI, GALZIN and DESMODA. At the start of 2026, we set 3 ambitious long-term goals for the company to help articulate to investors where we saw our business heading in the coming years. We like to set aspirational goals that push the envelope, not easy goals, and I know there was initially some skepticism about how achievable our goals were. From today's results, it's clear we are well ahead of that schedule. Our first goal was to reach a $200 million annualized revenue run rate by the end of 2027. We exited 2025 at about an $85 million run rate. So this required us to more than double our revenue within 24 months. As you saw, with nearly $58 million of revenue this quarter, we far exceeded this goal and did so an impressive 5 quarters ahead of schedule. Our second goal was focused on profitability, to produce a 50% adjusted EBITDA margin by 2028, up from the 20% we reported in 2025. It happened much faster. This quarter, we achieved a 49% adjusted EBITDA margin even after the expensing of our $3 million licensing payment for ASN-001, which was not adjusted out of the calculation. Our adjusted EBITDA margin may fluctuate quarter-to-quarter depending on the timing and size of certain R&D investments, but we believe we will now be operating in the ballpark of a 50% EBITDA margin over the coming quarters, and it should continue to increase in future years if revenue grows at the rate we expect it to. Our third goal was to reach $500 million of revenue in 2030. Once again, we believe we are well ahead of the pace we originally envisioned. Based on the Q3 run rate, we are nearly halfway to $500 million and the recent additions of ASN-001, HEMANGEOL and now LIBERVANT, have significantly increased our future revenue expectations compared to the levels that were expected at the start of 2026. Speaking of LIBERVANT, we are very excited about the transaction we announced just a few weeks ago to license the product. LIBERVANT is an orphan drug designated differentiated treatment for seizure clusters in patients with epilepsy awaiting FDA approval. LIBERVANT's innovative buccal film formulation offers an alternative to existing nasal and rectal seizure rescue treatments, a market that currently exceeds $450 million annually in the United States. Portability matters in this rescue therapy market. In an exploratory patient market research, roughly 3/4 of those surveyed were concerned about how the rescue medication within reach went away from home, yet only about 1/3 said they always carried it. That's a need we see an opportunity to address with LIBERVANT's portable film format once it is approved by the FDA. LIBERVANT is currently tentatively approved for patients with epilepsy, ages 2 to 5 and ages 12 and older. An NDA under review would add ages 6 to 11 to the label and has a late March PDUFA date. Subject to final FDA approval and resolution of applicable exclusivity restrictions, we anticipate launching in April 2027, and launch preparations are underway. LIBERVANT's film formulation builds on our experience commercializing differentiated dosage forms, including pediatric liquid and granules. The prescriber base also fits our commercial model. Nearly half of the market is concentrated among pediatric neurologists, a relatively small specialist base that we believe we can effectively reach with Eton's targeted sales force strategy. LIBERVANT offers a near-term growth driver and an entry into pediatric neurology. We believe pediatric neurology is one of the most attractive specialties that we are not already in. There are numerous orphan products approved and under development within neurology, including our recently announced ET-900 program, which I will discuss shortly. So we believe there is a compelling opportunity for us to build up an attractive presence in the space similar to what we have successfully done in pediatric endocrinology. Q3 was, without a doubt, the best commercial quarter in our history, but the developments in our pipeline over the last few months are even more exciting than our blockbuster financial results. I believe what is brewing in our pipeline will make our current levels look inconsequential within a few years. Our pipeline has been transformed in the last few months with the addition of 2 extremely high-value programs as well as the achievement of critical development milestones that have advanced our programs closer to commercialization. So I think it is worth dedicating more time to our pipeline this quarter. Our pipeline now has 9 programs, 3 of which could launch in 2027 and 4 that we believe have greater than $100 million revenue potential. I'll start with our newest addition, ET-900, which was just announced this week. Infantile spasms are a devastating condition that causes frequent seizures in very young children and can be associated with lasting development impairment. Unfortunately, around half of the patients do not respond to current treatment options, underscoring the need for new therapies. Dr. Swann's research at Baylor showed that the active ingredient in INCRELEX was highly effective at treating spasms in animal models. We have spent nearly a year preparing for this development and have now licensed patents from Baylor College of Medicine covering this indication. An investigator-initiated Phase II study has been planned with enrollment anticipated to begin in the first quarter of 2027. Because changes in spasm frequency may be observed within weeks of starting therapy, preliminary clinical data could be available as early as mid-2027. While this is an earlier-stage opportunity than Eton traditionally pursues, it offers a substantial opportunity to leverage one of our existing assets to potentially address a serious unmet need. We believe, for a total investment of less than $1 million, we can get through a proof-of-concept Phase II study, which will have the potential to verify efficacy for an incredibly important new treatment option. An estimated 2,500 patients each year are diagnosed with infantile spasms annually in the U.S. If successful and approved, we believe the product could generate annual revenue in the hundreds of millions of dollars. Today, we also released exciting results from our proof-of-concept study for ET-700, our extended-release zinc product. The 3-arm proof-of-concept study compared ET-700 to GALZIN and to placebo. We believe the results validated our thesis that an extended-release zinc formulation could reduce GI discomfort and adverse events. Lowering adverse events could drastically improve adherence and drive superior outcomes for patients. Treatment-related adverse events occurred in only 1 of 12 ET-700 participants compared with 8 of 12 GALZIN participants. ET-700 blocked copper absorption better than placebo, but not as well as our existing GALZIN product. We believe our release profile is actually too slow to maximize efficacy, and we have a strong plan to address it. We initially used a slower release profile. It may not have fully released by the time the product moved out of the small intestine where the methionine is produced. During formulation development, we had worked on a number of different formulations with varying release profiles. So we already have additional faster release formulations identified that we think could deliver what we are looking for. We will be running additional arms as part of the same clinical study protocol, which will allow us to quickly test the formulations with faster release profiles. We expect to run the follow-up arms in 2027, and we believe these faster release profiles will allow us to improve efficacy while preserving the attractive safety profile. During the third quarter, we closed the licensing of ASN-001. I discussed the program briefly in our last call. Just days after our licensing transaction, but after an additional 3 months of conversations with the physician community, including an advisory board at the recent Pediatric Dermatology Research Alliance annual meeting, we feel even more confident that ASN-001 will address a significant unmet need and is poised to become the largest revenue-generating product in our portfolio. While there are estimated to be more than 100,000 infants born in the U.S. every year with hemangiomas, only the most severe 10% or roughly 10,000 to 15,000 infants are candidates for systemic therapy with HEMANGEOL. HEMANGEOL is an FDA-approved treatment with a well-established safety and efficacy profile and remains an important treatment option for infants who require systemic therapy. However, physicians, especially general pediatricians and dermatologists, are selective about prescribing systemic therapy for infants, particularly for less severe cases and some parents can also be hesitant to give their babies a systemic medication, especially when the condition is not considered severe enough to warrant that level of treatment. This creates a significant opportunity for an effective FDA-approved topical treatment that could appeal to both physicians and families of patients with moderate hemangiomas, which is believed to be many multiples of the HEMANGEOL candidates. In addition, as a new product launch, ASN-001 will have much more favorable Medicaid rebate dynamics, which should translate to significantly higher net realized revenue per treatment compared to what we currently receive for HEMANGEOL. HEMANGEOL is a tremendous product that has been a home run success for the company, and we remain very enthusiastic about its continued growth. But when we consider the substantially larger potential patient population alongside the more favorable expected net revenue economics, we believe ASN-001 represents an even greater commercial opportunity and could ultimately become our largest product. We believe we have a straightforward path to market for the product with the bioavailability study being the last remaining hurdle. We have initiated the study with our CRO and expect to have the first patients dosed in January. It is a relatively short 28-day study, which should provide for an NDA submission in the middle of 2027 and a potential approval and launch in 2028. Our fourth pipeline program with more than $100 million in annual revenue potential is our INCRELEX label harmonization. As discussed on prior calls, aligning the U.S. indication with the European definition could expand the addressable market approximately fivefold. The study has now been initiated with our contract research organization, and we expect to dose the first patient in the coming months. Eton is also advancing programs that could contribute to growth as early as next year. Our KHINDIVI prior approval supplement was accepted for review and assigned a target action date of May 28, 2027. ALKINDI and KHINDIVI continue to grow steadily in their current form, but we remain convinced that this potential KHINDIVI label expansion could accelerate adoption and importantly, allow us to bring an important treatment option to more children living with adrenal insufficiency. Our team plans to be in position to launch the product very shortly after its potential approval in mid-2027. On Glyburide Oral Suspension, which is known as Amglidia in Europe, I'm pleased to share that we just completed our bioavailability study, which was one of the final requirements before NDA submission. We are awaiting the final study report and are finalizing the last few submission materials. Eton expects the NDA to go into the FDA in the coming months, allowing for a potential commercial launch in 2027. There are no oral treatments FDA-approved for use in neonatal diabetes, and the FDA has granted us fast track designation due to the critical need, so we are eager to bring the product to patients. Between the record revenue, rapidly expanding margins and robust late-stage pipeline, I hope it is clear that Eton's outlook has never been better. However, we are just getting started. We have set out to build the leading rare disease company, and our work is far from over. We plan to continue aggressively adding compelling products to our commercial portfolio and pipeline, expanding our reach to more patients and families living with rare diseases who need better treatment options. Ultimately, our success is measured not only by our financial performance, but by the number of patients whose lives we can positively impact. And our prospects for continuing to deliver on both have never been higher. We ended the quarter with $56 million of cash, an all-time high. We generated $35 million of cash from operations in the quarter, and we expect to continue generating significant amounts of cash going forward, providing us with significant capital to reinvest in new products. In addition, our recent success has boosted our inbound deal flow as companies are more actively looking to partner with Eton Pharmaceuticals. Our business development strategy will remain unchanged. We want to pursue late-stage or commercial rare disease assets where Eton is uniquely positioned to add value. But we now have the ability to execute on transactions substantially larger than what we have done historically. We remain confident that we can find compelling opportunities, both big and small, to add to our portfolio while still maintaining our discipline and high standards for strategic fit and financial returns. With that, I'll turn it over to Judy Matthews, our Chief Financial Officer, to discuss our financial results. Judy?