Teleconferência de resultados do 3T 2026 da Eton Pharmaceuticals (ETON): receita salta 158%, guidance elevado

Principais Destaques

• A receita do terceiro trimestre de 2026 cresceu 158% na comparação anual, para US$ 57,9 milhões, impulsionada por um trimestre completo de vendas do Hemangeol e pelo crescimento em todo o portfólio.
• O EBITDA ajustado aumentou para US$ 28,5 milhões, representando uma margem de 49%, frente a US$ 2,9 milhões e 13% no mesmo período do ano anterior. O resultado incluiu uma despesa de licenciamento de US$ 3 milhões para o ASN-001.
• A Eton Pharmaceuticals elevou seu guidance de receita para todo o ano de 2026 para mais de US$ 175 milhões, ante a projeção anterior de mais de US$ 145 milhões. A empresa agora projeta que a margem EBITDA ajustada supere 40%, acima do guidance anterior de mais de 35%.
• A companhia encerrou o trimestre com US$ 55,6 milhões em caixa após quitar US$ 5 milhões em dívidas. O fluxo de caixa das operações totalizou US$ 35 milhões, enquanto o saldo principal da dívida em aberto caiu para US$ 22 milhões.
• A administração afirmou que a Eton superou sua meta de taxa de receita anualizada (run-rate) de US$ 200 milhões cinco trimestres antes do previsto. O pipeline conta agora com nove programas, sendo que três podem ser lançados em 2027 e quatro possuem potencial de receita anual estimado pela gestão acima de US$ 100 milhões.
• Os catalisadores de curto prazo do pipeline incluem a data PDUFA do LiberVant no final de março de 2027, a data-alvo de ação do KINDIVI em 28 de maio de 2027 e as submissões planejadas de NDA para o ASN-001 e a suspensão oral de gliburida.

Principais Resultados Financeiros

Desempenho Comercial e Operacional

O Hemangeol foi o maior motor de crescimento sequencial, já que o 3T foi o primeiro trimestre completo após seu relançamento em 1º de maio. A administração informou que os preços líquidos ficaram próximos ao teto da faixa previamente discutida de US$ 8.000 a US$ 10.000, ou ligeiramente acima, devido ao mix favorável de produtos.

A empresa também reportou números recordes de pacientes ativos em suas principais marcas promovidas. O crescimento foi sustentado por produtos como Increlex, Alkindi Sprinkle, KINDIVI, Galzin, Chenodal, Dojolvi e ácido carglúmico.

A administração afirmou que o ritmo atual de pacientes do Hemangeol superou seu nível histórico de aproximadamente 8.000 pacientes. A Eton planeja uma expansão moderada de sua cobertura comercial em dermatologia pediátrica em 2027, visando pacientes que atualmente usam formulações orais genéricas off-label.

Prioridades do pipeline

• LiberVant: O tratamento de resgate para crises convulsivas em filme bucal tem aprovação provisória para pacientes de 2 a 5 anos e a partir de 12 anos. Um NDA em análise busca incluir a faixa de 6 a 11 anos, com data PDUFA no final de março de 2027. Sujeita à aprovação final da FDA e às restrições de exclusividade aplicáveis, a Eton prevê o lançamento para abril de 2027. A administração identificou os pacientes de aproximadamente 5 a 12 ou 13 anos como a maior oportunidade pediátrica.
• ASN-001: A Eton espera administrar a dose ao primeiro paciente em um estudo de biodisponibilidade de 28 dias em janeiro. A administração tem como meta a submissão do NDA em meados de 2027 e uma potencial aprovação e lançamento em 2028. A empresa acredita que o tratamento tópico para hemangioma infantil pode, futuramente, se tornar seu maior produto.
• ET900: Espera-se que um estudo de Fase 2 iniciado por pesquisadores com o princípio ativo do Increlex em espasmos infantis inicie o recrutamento no 1T 2027. Dados preliminares podem estar disponíveis até meados de 2027. A administração estima o investimento na prova de conceito em menos de US$ 1 milhão.
• ET700: A formulação inicial de zinco de liberação prolongada produziu menos eventos adversos relacionados ao tratamento do que o Galzin — um em 12 participantes contra oito em 12 —, mas não bloqueou a absorção de cobre com a mesma eficácia. A Eton planeja testar formulações de liberação mais rápida em braços adicionais do estudo ao longo de 2027, potencialmente no segundo ou terceiro trimestre.
• Harmonização da bula do Increlex: A Eton iniciou o estudo por meio de uma organização de pesquisa clínica e espera administrar a dose ao primeiro paciente nos próximos meses. A administração acredita que o alinhamento com a indicação europeia pode expandir o mercado endereçável em aproximadamente cinco vezes.
• KINDIVI: A FDA aceitou o suplemento de aprovação prévia e atribuiu a data-alvo de ação para 28 de maio de 2027. A Eton pretende lançar o produto logo após uma potencial aprovação.
• Suspensão oral de gliburida: O estudo de biodisponibilidade foi concluído, e a Eton espera submeter o NDA nos próximos meses, apoiando um potencial lançamento em 2027.

Guidance da Administração

O custo das vendas do quarto trimestre deve incluir um pagamento não recorrente de marco comercial de US$ 4 milhões no âmbito do contrato de licenciamento do Alkindi. O pagamento não será excluído da margem bruta ajustada.

A administração permanece confiante na meta de receita de US$ 500 milhões da companhia para 2030 e afirmou que o objetivo pode ser atingido antes do esperado inicialmente. No entanto, não forneceu um cronograma revisado.

Riscos e Pontos de Atenção

• O lançamento planejado do LiberVant continua dependente da aprovação final da FDA e da resolução das restrições de exclusividade aplicáveis.
• A formulação inicial do ET700 apresentou um perfil de tolerabilidade favorável, mas eficácia no bloqueio de cobre inferior à do Galzin. O desenvolvimento adicional depende da capacidade de formulações de liberação mais rápida aumentarem a eficácia sem comprometer a segurança.
• O ASN-001 ainda exige a conclusão de seu estudo de biodisponibilidade antes da submissão planejada do NDA.
• A margem EBITDA ajustada pode oscilar entre os trimestres a depender do cronograma e do volume de investimentos em P&D.
• A Eton está expandindo seu pipeline e portfólio comercial, o que exigirá contratações pontuais para as equipes regulatória, de qualidade e de operações.

Destaques da Sessão de Perguntas e Respostas com Analistas

A administração atribuiu o maior crescimento sequencial de receita a um trimestre completo de vendas do Hemangeol, ressaltando que todos os principais produtos promovidos atingiram recordes de pacientes ativos.

Em relação ao LiberVant, a Eton afirmou que pretende manter seu modelo direcionado de comercialização. A equipe dedicada se concentrará em cerca de 2.000 neurologistas pediátricos, especialmente epileptologistas, em vez de mobilizar uma ampla força de vendas voltada à atenção primária.

Quanto ao ET700, a administração afirmou que uma formulação de liberação mais rápida já havia sido desenvolvida durante o processo original de P&D. Os próximos braços do estudo buscam determinar se a liberação do zinco em cerca de quatro horas consegue melhorar a eficácia no intestino delgado, preservando a vantagem inicial de tolerabilidade.

Sobre a alocação de capital, a Eton afirmou que a forte geração de caixa operacional e o aumento no fluxo de potenciais negócios poderiam sustentar transações maiores do que seus acordos históricos. A empresa continuará priorizando ativos para doenças raras em estágio avançado ou já comerciais, nos quais acredita poder agregar valor operacional ou comercial.

Transcrição Completa da Teleconferência de Resultados

Transcrição completa da teleconferência de resultados

Comentários da administração

Operator

At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You'll then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please advise that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, David Krempa, Chief Business Officer at Eon Pharmaceuticals.

Please go ahead.

Unknown Speaker

Thank you, operator. Good afternoon, everyone, and welcome to Eaton's third quarter 2026 conference call. This afternoon, we issued our earnings release, which is available on our website, eatonpharma.com. Joining me today are Sean Brynjelsen, our CEO, Ipek Trinkas, our Chief Commercial Officer, and Judy Matthews, our Chief Financial Officer. Before we begin, I would like to remind everyone that remarks made during the call may contain forward-looking statements and involve risks and uncertainties that could cause actual results to differ materially from those contained in these forward-looking statements. Please see the forward-looking statements disclaimer in our earnings release and the risk factors in accompanying filings with the SEC. Now I will turn the call over to our CEO, Shawn Brynjelsson.

Sean Brynjelsen

Thank you, David. Good afternoon, everyone, and thank you for joining us today. It was another outstanding quarter for Eaton 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, in including Increlix, Hemangiol, Alkindi Sprinkle, Kindivi, Galzin, and Desmodo. At the start of 2026, we set three 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 five 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 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 right level. 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, Hemangiol, and now Livrevant have significantly increased our future revenue expectations compared to the levels that were expected at the start of 2026. Speaking of LibriVent, we are very excited about the transaction we announced just a few weeks ago to license the product. LibriVent 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. market that currently exceeds 450 million annually in the United States. Portability matters in this rescue therapy market. In the exploratory patient market research, roughly three-quarters of those surveyed were concerned about how their rescue medication within reach went away from home, yet only about one-third 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. LibriVent 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.

LibriVent'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 Eaton's targeted Salesforce 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 ET900 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 two extremely high-value programs, as well as the achievement of critical development milestones that have advanced our programs closer to commercialization. I think it is worth dedicating more time to our pipeline this quarter. Our pipeline now has nine programs, three of which could launch in 2027, and four that we believe have greater than 100 million revenue potential. I'll start with our newest addition, ET900, 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 developmental impairment.

Unfortunately, around half of the patients do not respond to current treatment options, underscoring the need for new therapies. Dr. Swan'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 two 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 Eaton 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. us. 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 ET700, our extended release zinc product. The three-arm proof of concept study compared ET700 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 one of 12 ET700 participants compared with eight of 12 Galzin participants.

ET700 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 metallothionein 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 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 three 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 Hemangiol. Hemangiol is an FDA-approved treatment with a well-established safety and efficacy 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 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 hemangiol 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 hemangiol. Hemangiol 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 is the right fit for the 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 a bioavailability study being the last remaining hurdle. We have initiated this study with our CRO and expect to have the first patient dosed in January. 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 KINDIVI prior approval supplement was accepted for review and assigned a target action date of May 28, 2027. Alkindi and KINDIVI continue to grow steadily in their current form, but we remain convinced that this potential KINDIVI label expansion could accelerate adoption and importantly allow us to bring 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 am 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. Eaton 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 Eaton'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 Eaton Pharmaceuticals. Our business development strategy will remain unchanged.

We want to pursue late stage or commercial rare disease assets where Eaton 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.

Unknown Speaker

Thank you, Sean. Third quarter revenue increased 158% to $57.9 million compared to $22.5 million in the third quarter of 2025, driven by the addition of revenue from Hemangiol, as well as year-over-year growth across our core. across the portfolio, in particular from Increlex, Elcysprinkle, Chenodal, Dojolvi, Galzin, and carglumic acid. We are increasing our 2026 revenue guidance and now expect full year revenue of more than $175 million, up from our previous guidance of more than $145 million. Gross profit for the quarter was $44.3 million compared to $7.9 million in the prior year period. Adjusted gross profit, which excludes the impact of acquired inventory step-up adjustments and intangible asset amortization, was $46.2 million in the third quarter of 2026, representing an adjusted gross margin of 80%. This compares to an adjusted gross margin of 45% in the prior year period. As a reminder, fourth quarter 2026 cost of sales is expected to include a one-time $4 million commercial milestone payment tied to the Alkindi licensing agreement. This expense will not be removed from adjusted gross margin.

We expect full year 2026 adjusted gross margin to approach 75% and continue to increase in 2027. R&D expenses for the quarter were $5.3 million compared to $1.1 million in the prior year period. The increase was primarily due to a $3 million upfront payment for the rights to ASN-001 and higher R&D spending for the development of glyburide oral suspension. General and administrative expenses for the quarter were $16 million compared to $8.1 million in the prior year period, an increase of 98%. Due primarily to higher stock-based compensation expense, increased compensation and benefits costs, reflecting additional headcount and business performance, higher operating costs to support a larger business and an expanded portfolio of commercial products, and higher FDA fees following the loss of eligibility for the orphan drug fee exemption. On an adjusted basis, which excludes the impact of share-based compensation, transaction-related costs, and other one-time expenses, G&A expense was 12.8 million compared to 6.9 million in the prior year period. The adjusted EBITDA for the third quarter of 2026 was $28.5 million, or 49% of revenue, compared to $2.9 million, or 13% of revenue in the prior year period.

We now expect our full year 2026 adjusted EBITDA margin to exceed 40% up from our prior guidance of more than 35%. Total company net income was $35.2 million, or $1.06 per diluted share, compared to a net loss of $1.9 million, or 7 cents, per basic and diluted share in the prior year period. As we mentioned in the last earnings call, during the third quarter, we released the valuation allowance associated with our federal and a portion of our state deferred tax assets, resulting in the recognition of an income tax benefit for the period. On a non-GAAP basis, we reported net income of $16.5 million for the third quarter of 2026, compared to $1.5 million in the prior year period. Diluted earnings per share were 50 cents compared to 4 cents per share in the prior year period. The one-time non-cash income tax benefit described above was removed for purposes of non-GAAP net income. We ended the third quarter with $55.6 million in cash after making a $5 million prepayment on our debt facility during the quarter, which reduced outstanding principal balance to $22 million.

This concludes our remarks on third quarter results. With that, we'll turn the call back over to the operator for Q&A.

Operator

Thank you. At this time, we'll conduct the question and answer session. As a reminder, to ask a question, you'll need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. And our first question comes from the line of Chase Knickerbocker of Craig-Hallum. Your line is now open.

Perguntas e respostas

Chase Knickerbocker

Good afternoon. Thanks for taking the questions and congrats again on a great quarter here. Maybe just to start on GAAP sequentially. So if we look at the sequential growth, can you maybe just kind of stack order in kind of order of magnitude, kind of the growth drivers sequentially as far as the level of sequential growth and then any sort of. kind of greater detail into the magnitude of each growth driver would be helpful. Thanks.

Unknown Speaker

Hey Chase, this is David. The biggest sequential growth driver, of course, is the full quarter from ANGEL. So as you know, second quarter, we relaunched the product May 1st. May, there was a lot of transition, a lot of bridge product, so real June was the only full month and May was a partial month. Versus Q3 here, we had three full months of Hemangeol sales, so that was obviously a very big growth driver. But we also had strong performance across the portfolio. So, you know, we don't break out individual products, but we have many other products that are promoting that are selling better than we expected in our original forecast. As we called out on the press release, all of our key promoted products reach all-time high active patient counts in Q3.

So very happy with the performance across the board.

Chase Knickerbocker

And maybe just if you could give us an update around your expectations on net price for hemangiol. You know, are we above that kind of range that we previously stated in that kind of $8,000 to $10,000 range? Maybe just an update there. And then I've got one follow-up.

Unknown Speaker

Yes, price has been a little bit more favorable, a little more favorable product mix than we originally thought. but closer to the top end of the range, maybe just a little bit over, but, And we've been very happy with it so far.

Chase Knickerbocker

And then if you could just give us a sense for kind of your updated timelines around ET700. I know there's still work to do, but can you maybe just, you know, I'd like to just gauge your confidence on kind of the formulations that you are kind of moving forward into those additional studies next year and just what you think it means for a pivotal trial timeline.

Sean Brynjelsen

Hi, Chase, this is Sean. We had already developed a shorter release formulation. At the time, we didn't want to run four arms, so we chose one that we thought would would function best, but what we didn't realize is that most of the action is in that small intestine area. With that, we believe our other formulation that was done last year is ideal to achieve that objective. We need some data to inform us on how to proceed with the study. So now that we've got that data with this interim analysis, I believe we can complete the follow-up portion of this study in, let's say sometime in 2027, I think is the safe answer, but I'm optimistic we can get this in the second or third quarter, let's say.

Unknown Speaker

Got it. Thanks, guys. Congrats again. Thank you. Thank you. We'll move on to our next question.

Operator

Our next question comes from the line of Gary Nachman of Canaccord Genuity.

Gary Nachman

Thanks, and my congrats as well on the really great quarter. So on hemangio, back to that, just how durable is that level of revenue in terms of patients cycling on and off drug, you know, thinking about where it goes from here? And how are you looking to expand penetration within severe infantile hemangioma patients, I guess, until you have 001 on board? And did you expand the pediatric derm sales force or will you be doing that? I think you mentioned that last quarter, but then I have a follow up. Hi Carrie, this is Sean.

Sean Brynjelsen

I'll turn that over to our chief commercial officer, Ipek. Hi, Gary.

Sean Brynjelsen

I think basically we historically mentioned that there are around 8,000 patients historically on hemangioles. So we are based on our current, this is before ETHON time, based on our current run rate, we are feeling pretty good that not only we brought those back patients phase over, we are already seeing growth. right now above and beyond that historical number. There is definitely a quite a bit of percentage still that we know to be on generic off-label oral formulations. So we are actively working across all institutions on prescribers to be able to penetrate that use. We have several new initiatives going on. We have not made a change on this at the time, at this time, but we are actually looking at expanding it in the following year. It's going to be a modest growth.

Our current sales force has pretty strong relationships already, so we don't want to make a big change. We are confident that we have the right relationships and with the right initiatives in place, right, engagement, now that the specialty pharmacy transition is stable, we are going to be able to penetrate more of the generic use.

Gary Nachman

Okay, great. That's helpful. And then just with your move into rare neuro. maybe you could talk about the due diligence you did on Limbervant, your comfort level with where they are in the regulatory process. And I guess how you'll be attacking that market for seizure clusters, no pun intended. Yes, so I'll take the first part of that one. Go ahead, Jerry. Yes, just following on that, just how big will the dedicated neuro team be? What will you be able to leverage across the other therapeutic areas? And are you planning on pricing this like a rare disease drug, given that it might be a little bit.

Sean Brynjelsen

a bigger market. Thanks. Okay. On the pricing, we likely won't comment, but I would say we do consider this to be a rare disease. It fits very well with Eaton's M&A and licensing strategy. We look for assets which are later stage, which are generally in a smaller prescriber base. We We don't foresee the sales force being that significant, significantly larger than what we have on some of our other therapeutic areas. I'd say from a due diligence standpoint, we feel very comfortable with the filing and we're optimistic that the product will get approved and launched.

Sean Brynjelsen

ideally get the age groups we're seeking. Yvette, you want to take some of the other parts of that question? Sure, Gary. I think in terms of your question on goals to markets in general. I think we are going to not steer away from our model of building a hyper-targeted specialized sales force, so it's going to be a dedicated sales force. We are obviously going to be in a market where we are going to be competing with branded products. So we are basing our commercial infrastructure based on that, but it's going to still be a highly efficient hyper-targeted sales force targeting those 2000 pediatric neurologists, especially with a subset that are epileptologists. which is a smaller subgroup versus the general ped neuro targets.

Gary Nachman

is likely going to be on this for any people with severe planning. Okay. We should think of that 450 million market opportunity as the addressable market for you. That it has the potential to be a couple hundred million. I would say yes. We believe the dosage form offers significant advantages, and so we'll see what happens. Okay. Great. Congrats again. Thank you. Thank you.

Operator

Thank you, one moment for our next question. Our next question comes from the line of Madison El-Sadi of B. Riley. Your line is now open. Madison, your line is now open.

Madison Wynne El-Saadi

Hi, guys. Thanks. Thanks for taking our question, and congrats on a really great quarter. Now that you've passed the 200 million exit 27 run rate goal that you had previously set, you have also set a 500 million 2030 target. I guess, how should we think about the target now that replaces those? And then if I, I'll go ahead and ask on Wilson disease, how should we think about the value of your Wilson franchise. And is the 12 to 18% reduction in hepatic copper, is that therapeutically meaningful? Just wondering, you know, what tells you if the faster release formulation, to what extent that closes the gap without giving back the tolerability advantage?.

Sean Brynjelsen

Thanks. Okay, I'll take the last question first on the ET700. So the idea was to have a slow release version of of zinc, basically an extended release version of Galzin, that could be used twice a day. So we had an eight hour release profile. However, the, release profile we're looking at is, needs to be about half that or less. Because most of that will have already passed through the small intestine, and once you get past hour four, let's say, after ingestion. So I feel pretty good that that shorter release profile will do exactly what we need it to do. We didn't know where we needed to be until we saw some data.

So now we have a direction to point and we have that formulation, fortunately, that was developed as part of the R&D process. And the program is very much alive and we feel very optimistic that we'll get there. Not every swing is going to result in a home run, but we are going to give it another study in 2017 and we'll report and hopefully have some positive results to report back. So, and the second part of your question? Oh, the 500 million. So we announced that $500 million goal by 2030, prior to us doing the ASM001 deal. ASM001 we've stated will be our largest product, at least as of today. We are optimistic that that 500 million will be achieved much earlier than what we've stated previously, but I'm not going to give a specific timeframe on it.

We'll update that when the time is right.

Madison Wynne El-Saadi

Got it. That sounds very helpful, Sean. Thank you. If I may ask one more on Librela, a bit of a follow-up to the prior question. which of these three age groups really represent the largest opportunity and just what kind What kind of penetration do you think you could get across those age groups?.

Sean Brynjelsen

Hi Madison, Ipek here. So if you look at the, so we are basically basing it currently on, you can look at two ways. One, where the current the legal product is penetrated versus where we see the Libervant opportunity. I would say right now, based on what we are learning from the epileptologist as well as patient's research, we think the biggest opportunity is going to be in the middle age group, so basically patients that are above five. and before those teenager years basically so if you all I'm only speaking to pediatric obviously there's going to be an adult opportunity as well but if you look at the pie as the pediatric from 2 to 18 the largest opportunity we are building around is going to be between this 5 to 12 to 13 age group. As much as 2 to 5 intuitively some like it would be the right it would be a big opportunity actually if you look at the market numbers it only represents less than 5% of the current utilization for the other form for the nasal form so that's just because there is also rectal option for those very younger kids so we think that that sweet spot is going to be that middle age group.

Madison Wynne El-Saadi

Understood. Thanks, everyone, and congrats again on the progress. Thank you.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Swayam Ramakanth of H.C. Wainwright. The line is now open.

Swayampakula Ramakanth

Thank you. Good afternoon, Sean and team. Congratulations on a great quarter. and hitting some of your major milestones. Looking into your guidance for the year, all you need is a flat quarter and you can get to 178 million, which is about, 175, the range that you're giving us. So, Well, we didn't give you 175. Higher than 175. You gave the base. I apologize. Well, we didn't give you a range. We said more than 175. Higher than 175.

So, what are you considering? Is it going to be some seasonal or reimbursement or channel factors, something that's making not to be a bit more bullish than stating just greater than 175.

Sean Brynjelsen

Well, I think what we like to do is to give the street numbers that we feel confident that we can meet. When we have a quarter which is growing well across all the major products, We didn't necessarily know that the second half of this year was going to be that strong, but we're seeing continued momentum. So it's a moving target in a good way. I give guidance that we take a lot of pride in our ability to have trust by the street. You know, trust is the most important aspect of what we do at the company. So I don't want to, obviously, to be overly conservative, but we don't want to get into the whole salesmanship thing. Just give numbers that we know we can meet, that we tell the street, and they can count on that.

That's just our approach. Maybe it's different from other companies, but that's our style.

Swayampakula Ramakanth

Okay, no thanks for that. One additional quick question. You know, as you said in the opening remarks, you know, you have a decent sized pipeline of eight or nine molecules there. And then, you know, I'm just trying to understand how you're balancing resources between different developing your pipeline and also at the same time you have been in licensing molecules pretty at a good cadence level at this point. How would you be planning to balance that over the next couple of years?.

Sean Brynjelsen

It's a good question. I think we've added resources throughout the quarter, but judiciously, it's not something that always benefits by just having more people on the company. We have one of the highest revenues per employee, probably in industry. And we take pride in that, but we do go out and try to hire the best talent we can find in the market. People that know what they're doing and can execute on that with not a lot of over oversight, it was day-to-day oversight. I feel very good about the team. I've never felt better about the management team. The bench, and also the bench, is very strong across the board.

We are planning on adding, as we add more products, we have to beef up regulatory and quality in our operations team, but we do so in a very, like i said judicious way i feel very good about the product launches we're not worried about that aspect of it and in fact i look at other companies that have huge teams for a single product launch and i would flip the question and say why do you need so many people for that.

Swayampakula Ramakanth

Yes. Yes. And then, you know, the very recent announcement about ASN-001, which is kind of an interesting thing in the sense. Normally, you don't start off developing a molecule from that early stage. So what gives you confidence in that molecule that you can take it all the way into the market?.

Sean Brynjelsen

Well, it's almost ready to file. We have one more study we have to do, which is relatively straightforward. The NDA is mostly compiled, and we feel confident we're going to get that submitted in the middle of next year um you know the company that worked on this had worked on it over 10 years so they had many meetings with the FDA we did a due diligence exercise that was thorough and I felt very good about the data and the quality of the submission.

Swayampakula Ramakanth

Okay, great. Thanks for taking me on. I think, yes, I confused myself. It's actually ET900, so I thought I'd ask you. Oh, yes, because that's a different story.

Sean Brynjelsen

Let me ask you one question. Were you referring to ASN or were you referring to ET900? Because that's our Increlex as well. That's a different story. All right. Yes, understood. Let me just provide some color on ET900. So ET900 utilized the active ingredient in Incralex. The University of Chicago and Baylor University had studied the active ingredient in Incralex, which is IGF-1. for several years before we ever took over this product. They had run animal studies showing that it had a very, let's say Baylor ran an animal study and has published that data, showing it has a strong effect on reducing epileptic seizures or infantile seizures.

We feel very good about this. One of the observations they noted was IGF-1 levels were lower in children or babies that suffered from infantile spasms. And so there was a plausible mechanism of action that by supplementing and providing IGF-1 externally, that it would have an impact on the seizures, which we believe it will. It will be a very important launch, not for the revenue or any of that, but really mainly for these children that suffer from it. on this, 50% of children with infantile spasms have no good treatment options. And it's very scary. It's scary for parents. I've talked to family members who had to go through that, and it'll be very satisfying to see that this works.

Swayampakula Ramakanth

Great. Thank you. Thanks for taking all my questions. You're welcome.

Operator

Thank you. I'm showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

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