伊頓製藥 (ETON) 2026年第三季財報電話會議：營收大增 158%，調升財測指引

重點摘要

• 受惠於 Hemangeol 完整季度的銷售貢獻，以及整體產品組合的成長，2026 年第三季營收年增 158% 至 5,790 萬美元。
• 調整後 EBITDA 增加至 2,850 萬美元，利潤率達 49%，相較於去年同期的 290 萬美元及 13%；該業績已計入 300 萬美元的 ASN-001 授權費用。
• Eton Pharmaceuticals 將 2026 全年營收財測由超過 1.45 億美元上調至超過 1.75 億美元，目前預期調整後 EBITDA 利潤率將超過 40%，高於先前預期的超過 35%。
• 在償還 500 萬美元債務後，公司季末現金部位為 5,560 萬美元。營運現金流總計 3,500 萬美元，未償債務本金則降至 2,200 萬美元。
• 管理階層表示，Eton 提前五個季度達成了 2 億美元年化營收運作率（run-rate）目標。目前的研發管線包含九項專案，其中三項可能於 2027 年推出，且有四項被管理階層評估年營收潛力超過 1 億美元。
• 近期研發管線催化劑包括 LiberVant 於 2027 年 3 月底的 PDUFA 目標審查日、KINDIVI 於 2027 年 5 月 28 日的目標審查日，以及 ASN-001 和格列本脲（glyburide）口服懸浮液預計提交的 NDA。

核心財務業績

業務與營運表現

Hemangeol 是最大的季增動能，因為第三季是該藥自 5 月 1 日重新上市後的第一個完整季度。管理階層表示，受惠於有利的產品組合，淨價格接近先前討論的 8,000 至 10,000 美元區間高標，或略高於該區間。

該公司還指出，旗下主要推廣品牌在治療中的活躍患者人數均創歷史新高。推動成長的產品包括 Increlex、Alkindi Sprinkle、KINDIVI、Galzin、Chenodal、Dojolvi 和卡穀氨酸（carglumic acid）。

管理階層表示，Hemangeol 目前的患者運作率已超過歷史水準的約 8,000 名患者。Eton 計劃於 2027 年適度擴大小兒皮膚科的商業推廣覆蓋範圍，同時鎖定目前非適應症使用學名口服製劑的患者。

研發管線重點

• LiberVant：這款用於癲癇發作急救的口頰溶膜劑型已暫時獲准用於 2 至 5 歲及 12 歲以上的患者。審查中的 NDA 旨在擴大適用於 6 至 11 歲患者，PDUFA 目標審查日為 2027 年 3 月底。在獲得 FDA 最終批准並取決於相關專利獨占權限制的情況下，Eton 預期將於 2027 年 4 月上市。管理階層指出，約 5 至 12 或 13 歲的患者是小兒領域最大的市場機會。
• ASN-001：Eton 預計將於 1 月在一項為期 28 天的生物利用度研究中對首位患者進行給藥。管理階層目標是在 2027 年年中提交 NDA，並有望於 2028 年獲准上市。該公司認為這款外用嬰兒血管瘤治療藥物最終可能成為旗下規模最大的產品。
• ET900：一項由研究者發起、評估 Increlex 活性成分治療嬰兒點頭痙攣的二期臨床研究，預計將於 2027 年第一季開始招募患者。初步數據可能於 2027 年年中公布。管理階層估計該概念驗證階段的投資額低於 100 萬美元。
• ET700：初步的緩釋鋅配方所引起的治療相關不良事件少於 Galzin（12 名受試者中僅 1 名，而 Galzin 為 12 名中有 8 名），但在阻斷銅吸收方面的效果不如預期。Eton 計劃於 2027 年（可能在第二或第三季）透過新增研究組別測試釋放速度更快的配方。
• Increlex 標籤調和：Eton 已透過受託研究機構（CRO）啟動研究，預計在未來幾個月內為首位患者給藥。管理階層認為，若與歐洲適應症保持一致，目標市場規模將可擴大約五倍。
• KINDIVI：FDA 已受理其事先批准補充申請，並將目標審查日訂為 2027 年 5 月 28 日。Eton 計劃在獲得潛在批准後不久即刻推出該產品。
• 格列本脲口服懸浮液：生物利用度研究已完成，Eton 預計將於未來幾個月內提交 NDA，以支援 2027 年的潛在上市。

管理階層財測

第四季銷售成本預計將包含 Alkindi 授權協議項下的一筆 400 萬美元一次性商業里程碑款項。該筆款項不會在調整後毛利率中剔除。

管理階層對公司 2030 年達成 5 億美元營收目標仍具信心，並表示該目標可能早於最初預期達成。然而，公司並未提供修改後的時間表。

風險與關注焦點

• LiberVant 預定的上市計畫仍取決於 FDA 的最終核准以及相關專利獨占權限制的解決。
• ET700 的初步配方具備良好的耐受性，但阻斷銅吸收的療效低於 Galzin。後續開發將取決於釋放速度更快的配方能否在不犧牲安全性的前提下提升療效。
• ASN-001 在預計提交 NDA 之前，仍需完成其生物利用度研究。
• 調整後 EBITDA 利潤率可能因研發投資的時間點與規模而在各季度間出現波動。
• Eton 正在擴展其研發管線與商業化產品組合，這將需要選擇性地增加法規、品質與營運方面的人力。

分析師問答重點

管理階層將營收最大幅度的季增長歸功於 Hemangeol 完整季度的銷售貢獻，同時強調所有主要推廣產品的活躍患者人數均創下歷史新高。

關於 LiberVant，Eton 表示計劃維持其精準商業化模式。專屬團隊將聚焦於約 2,000 名小兒神經科醫師（特別是癲癇專科醫師），而非配置廣泛的基層醫療銷售團隊。

針對 ET700，管理階層表示在最初的研發過程中就已開發出釋放速度更快的配方。下一階段的研究組別旨在確定讓鋅在約四小時內釋放是否能在小腸中提升療效，同時維持最初的耐受性優勢。

在資本配置方面，Eton 表示強勁的營運現金流入及日益增多的潛在合作案，可支持規模大於過往交易的合作。公司將繼續優先考慮具備營運或商業增值空間的後期或已商業化罕見疾病資產。

電話會議完整逐字稿

完整財報電話會議逐字稿

管理層陳述

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.

分析師問答

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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