Eton Pharmaceuticals Inc (ETON) 2025 Q4 法說會逐字稿

Good afternoon, and welcome to the Eton Pharmaceuticals fourth-quarter 2025 financial results conference call. (Operator Instructions) Please be advised that this call is being recorded at the company's request.

下午好，歡迎參加伊頓製藥公司2025年第四季財務業績電話會議。（操作員指示）請注意，本次通話正在依照本公司要求進行錄音。

At this time, I'd like to turn it over to David Krempa, Chief Business Officer at Eton Pharmaceuticals. Please proceed.

現在，我想把發言權交給伊頓製藥公司的首席商務官大衛克倫帕。請繼續。

Thank you, operator. Good afternoon, everyone, and welcome to Eton's fourth-quarter 2025 conference call. This afternoon, we issued a press release that outlines the topics we plan to discuss on today's call. The release is available on our website, etonpharma.com.

謝謝接線生。各位下午好，歡迎參加伊頓公司 2025 年第四季電話會議。今天下午，我們發布了一份新聞稿，概述了我們計劃在今天的電話會議上討論的主題。新聞稿可在我們的網站 etonpharma.com 上取得。

Joining me on our call today, we have Sean Brynjelsen our CEO; James Gruber, our CFO; and Ipek Trinkaus, our Chief Commercial Officer. In addition to taking live questions on today's call, we will also be answering questions that are e-mailed to us. Investors can send their questions to investor relations at etonpharma.com.

今天和我一起參加電話會議的有：我們的執行長 Sean Brynjelsen；我們的財務長 James Gruber；以及我們的商務長 Ipek Trinkaus。除了在今天的電話會議上接受現場提問外，我們還將回答透過電子郵件發送給我們的問題。投資者可以將他們的問題發送至 etonpharma.com 的投資者關係部門。

Before we begin, I would like to remind everyone that remarks made during this call may contain forward-looking statements and involve risks and uncertainties and that could cause actual results to differ materially from those contained in these forward-looking statements. Please see the forward-looking statements disclaimer in our earnings release and the risk factors in the company's filings with the SEC.

在開始之前，我想提醒大家，本次電話會議中發表的言論可能包含前瞻性陳述，並涉及風險和不確定性，這些風險和不確定性可能導致實際結果與這些前瞻性陳述中包含的結果有重大差異。請參閱我們獲利報告中的前瞻性聲明免責聲明以及公司向美國證券交易委員會提交的文件中的風險因素。

Now I will turn the call over to our CEO, Sean Brynjelsen.

現在我將把電話交給我們的執行長肖恩·布林傑爾森。

Thank you, David. Good afternoon, everyone, and thank you for joining us today. As you've seen, it's been a very active time at Eton with a number of major developments in the recent weeks, and we have some exciting topics to discuss today.

謝謝你，大衛。各位下午好，感謝各位今天參加我們的節目。正如你所看到的，伊頓公學最近幾週非常活躍，發生了許多重大事件，今天我們有一些令人興奮的話題要討論。

During the call, we'll review fourth-quarter results provide additional color on HEMANGEOL acquisition and an update on our recent FDA approval and commercial launch of DESMODA. We'll also cover growth trends in our on-market products and provide an update on clinical development programs. And finally, we'll provide 2026 financial guidance and unveil our new long-term goals for the company.

在電話會議中，我們將回顧第四季度業績，詳細介紹 HEMANGEOL 收購情況，並更新我們最近獲得 FDA 批准和 DESMODA 商業化上市的最新情況。我們也將介紹我們已上市產品的成長趨勢，並提供臨床開發專案的最新進展。最後，我們將提供 2026 年財務預期，並公佈公司新的長期目標。

Let me start with our financial results. It was another strong quarter for Eton, capping off an outstanding year. 2025 was truly another transformational year for our company as we successfully launched three new products, INCRELEX, GALZIN and KHINDIVI. These were not minor products. They represent important cornerstones of our long-term growth plan. These new products helped us more than double our revenue in 2025 compared to 2024 and set us up for a major growth in 2026 and beyond.

首先，讓我從財務業績談起。伊頓公司又迎來了一個強勁的季度，為卓越的一年畫上了圓滿的句號。 2025年對我們公司而言又是意義非凡的一年，我們成功推出了三款新產品：INCRELEX、GALZIN和KHINDIVI。這些並非次要產品。它們是我們長期發展計劃的重要基石。這些新產品幫助我們在 2025 年的收入比 2024 年翻了一番還多，並為 2026 年及以後的大幅成長奠定了基礎。

Our fourth-quarter product revenue was $21.3 million, an increase of 83% year over year driven by continuing strong performance from ALKINDI SPRINKLE and the addition of revenue from INCRELEX, GALZIN, KHINDIVI and [ALKINDI]. GALZIN and INCRELEX have continued to be great success stories for Eton. Both products were relaunched by Eton in early 2025 and contributed revenue well beyond our initial expectations for the year.

我們第四季的產品收入為 2,130 萬美元，年增 83%，這主要得益於 ALKINDI SPRINKLE 的持續強勁表現，以及 INCRELEX、GALZIN、KHINDIVI 等品牌收入的增加。[ALKINDI]。GALZIN 和 INCRELEX 一直是 Eton 巨大成功的案例。伊頓公司於 2025 年初重新推出了這兩款產品，其帶來的收入遠遠超出了我們最初的預期。

A key goal for us in continuing to drive strong revenue growth while maintaining our focus on profitability through disciplined cost management and expanding margins. And I'm pleased to report that we made meaningful progress on that in the fourth quarter as our adjusted EBITDA margin was 29%, a significant improvement from 18% in the prior-year period.

我們的關鍵目標是在保持獲利能力的同時，繼續推動強勁的營收成長，並透過嚴格的成本管理和擴大利潤率來實現這一目標。我很高興地報告，我們在第四季度取得了實質進展，調整後的 EBITDA 利潤率為 29%，較上年同期的 18% 有了顯著提高。

We also reported GAAP net income of $1.5 million and non-GAAP net income of $5.4 million. Looking ahead, we expect our profit margin profile to continue improving as revenue scales across our portfolio. And we will further discuss our profitability outlook later in the call when we communicate new long-term goals.

我們也公佈了 GAAP 淨收入 150 萬美元和非 GAAP 淨收入 540 萬美元。展望未來，隨著我們產品組合收入的成長，我們預期利潤率狀況將持續改善。我們將在稍後的電話會議中進一步討論我們的獲利前景，屆時我們將公佈新的長期目標。

Now let me turn to one of our most important recent developments. The approval and launch of our oral liquid formulation of desmopressin, DESMODA, which received FDA approval at the end of February for the treatment of central diabetes insipidus, Diabetes insipidus is a serious condition caused by inadequate production of the hormone vasopressin and treatment with desmopressin is the standard of care.

現在讓我來談談我們近期最重要的進展之一。我們口服液體製劑去氨加壓素 DESMODA 已獲批准上市，該產品於 2 月底獲得 FDA 批准，用於治療中樞性尿崩症。尿崩症是一種嚴重的疾病，由荷爾蒙血管加壓素的產生不足引起，而去氨加壓素治療是標準療法。

Dosing is patient-specific and must be individualized and fine-tuned over time, but there were historically no products available that could provide accurate low doses of desmopressin. As a result, clinicians and caregivers were forced to use workarounds, including splitting or crushing tablets. As the only FDA-approved liquid oral formulation, DESMODA offers patients a treatment option that provides precision, consistency and convenience, fulfilling a large unmet need frequently expressed to us by pediatric endocrinologists.

劑量因人而異，必須隨著時間的推移進行個人化調整和微調，但歷史上沒有產品能夠提供準確的低劑量去氨加壓素。因此，臨床醫生和護理人員被迫使用變通方法，包括掰開或碾碎藥片。作為唯一獲得 FDA 批准的液體口服製劑，DESMODA 為患者提供了一種治療選擇，具有精準性、一致性和便利性，滿足了兒科內分泌學家經常向我們表達的巨大未滿足需求。

Leveraging our established team of pediatric endocrinology rare disease specialists, we launched DESMODA within two weeks of FDA approval. While we are still in the early phases of launch, I could not be happier with how DESMODA watch is going. I believe this was the most well prepared we urban for a commercial launch.

憑藉我們經驗豐富的兒科內分泌罕見疾病專家團隊，我們在獲得 FDA 批准後的兩週內推出了 DESMODA。雖然我們仍處於產品發布的早期階段，但我對 DESMODA 手錶的進展非常滿意。我認為這是我們城市為商業發布準備得最充分的一次。

Our entire team was ready to execute on day one and initial demand of interest in the product has been incredibly encouraging. Our team has been hard at work promoting the product for two weeks and we've already seen significant traction.

我們的整個團隊從第一天起就做好了執行準備，而且市場對該產品表現出的初步興趣也令人非常鼓舞。我們的團隊已經努力推廣這款產品兩週了，並且已經看到了顯著的成效。

Many institutions that were historically unreceptive to sales visits have reached out to us asking for meetings because they are interested in learning about the product. We've already seen a number of patients begin therapy in the first 1.5 weeks of launch.

許多過去對銷售拜訪不感興趣的機構現在主動聯繫我們，要求會面，因為他們對了解產品很感興趣。在產品上市後的前 1.5 週內，我們已經看到一些患者開始接受治療。

Another important aspect of the approval is that DESMODA received a clean label with no age restriction. In fact, the FDA's indication even includes adults. This means that our addressable market will not be solely the 3,000 to 4,000 children in the US. We will also be able to meet the therapeutic needs of the 9,000 to 10,000 adults living with central diabetes insipidus.

此次批准的另一個重要方面是，DESMODA 獲得了清潔標籤，沒有年齡限制。事實上，FDA的適應症甚至包括成年人。這意味著我們的目標市場不僅僅是美國的 3000 到 4000 名兒童。我們也能夠滿足 9000 至 10000 名患有中樞性尿崩症的成年人的治療需求。

Our historic market assessment and $30 million to $50 million peak sales forecast were based solely on the pediatric market. However, we believe there could be a meaningful incremental opportunity within the adult population for patients who have difficulty swallowing tablets, require precise and titratable dosing or simply prefer a liquid option.

我們先前的市場評估和 3,000 萬至 5,000 萬美元的銷售高峰預測完全基於兒科市場。然而，我們認為，對於吞嚥藥片有困難、需要精確且可滴定的劑量或只是更喜歡液體選擇的患者來說，成年患者群體中可能存在一個有意義的增量機會。

While the percentage of adults needing a liquid or precise dose will likely be smaller, the population is roughly three times as large, so it could be a quite meaningful number of patients. This month, we are launching a pilot initiative where our existing sales team will target high desmopressin prescribing adult endocrinologists. We will assess the opportunity over the next 90 days. And if we see traction with the adult patient community, we will expand our commercial efforts to fully capture this additional opportunity.

雖然需要液體或精確劑量的成年人比例可能較小，但人口數量大約是成年人的三倍，因此患者人數可能相當可觀。本月，我們將啟動一項試點計劃，由我們現有的銷售團隊瞄準開立大量去氨加壓素處方的成年內分泌科醫生。我們將在接下來的90天內評估這個機會。如果我們看到在成年患者群體中獲得了認可，我們將擴大商業努力，以充分把握這一額外機會。

Regarding pricing, the dosing varies by patients, but we believe we will net an average of approximately $80,000 per patient per year. As I said, it is still too early in the loss to say definitively, but all initial signs are pointing to a successful launch for DESMODA. For now, we're confirming our guidance of $30 million to $50 million in potential peak sales.

關於定價，劑量因患者而異，但我們相信平均每位患者每年可淨賺約 80,000 美元。正如我所說，現在下定論還為時過早，但所有初步跡像都表明 DESMODA 的發布將會成功。目前，我們確認先前的預期，即潛在銷售高峰將達到 3,000 萬美元至 5,000 萬美元。

We should know more in the coming quarters, and we'll update our outlook accordingly. DESMODA also benefits from strong intellectual property protection via multiple patents extending to 2044, which we believe positions the product as a critical long-term value driver for Eton.

接下來的幾個季度我們應該會了解更多信息，屆時我們將據此更新我們的展望。DESMODA 也受益於多項專利的強大智慧財產權保護，這些專利的有效期至 2044 年，我們認為這使該產品成為 Eton 的關鍵長期價值驅動因素。

Turning now to our other pediatric endocrinology assets. When we acquired INCRELEX in December 2024, the product only had 67 patients on therapy. We saw a tremendous opportunity to increase awareness and education of severe primary insulin-like growth factor one deficiency, otherwise known as SPIGFD.

現在讓我們來看看我們其他的兒科內分泌資源。2024 年 12 月我們收購 INCRELEX 時，該產品只有 67 名患者正在接受治療。我們看到了一個絕佳的機會，可以提高人們對嚴重原發性胰島素樣生長因子 1 缺乏症（又稱 SPIGFD）的認識和教育。

In conjunction with our relaunch of INCRELEX in January of 2025, we kicked off an extensive disease and therapy education campaign to complement physician engagement efforts of our season pediatric endocrinology sales team. This included targeted outreach to health care providers, strong conference engagement and endocrinology space, peer-to-peer presentations and strategic collaboration with patients and patient advocacy groups.

配合我們在 2025 年 1 月重新推出 INCRELEX，我們啟動了一項廣泛的疾病和治療教育活動，以補充我們經驗豐富的兒科內分泌銷售團隊的醫生參與工作。這包括有針對性地接觸醫療保健提供者、積極參與會議和內分泌學領域、同儕交流以及與患者和患者權益倡導團體進行策略合作。

INCRELEX is approved for pediatric patients age two and up and is highly effective at increasing height during critical development years. Because earlier diagnosis leads to better outcomes, increasing awareness and improving time to diagnosis are central to our strategy, ensuring that every patient achieves their full therapeutic potential.

INCRELEX 已獲準用於兩歲及以上的兒童患者，在關鍵發育時期能有效增高。因為早期診斷能帶來更好的治療效果，所以提高大眾意識和縮短診斷時間是我們策略的核心，以確保每位患者都能充分發揮其治療潛力。

We are already seeing encouraging progress. Since acquiring the product, we have meaningfully reduced the average age of which patients begin therapy and continue to see steady growth in the treated population. Based on ongoing discussions with physicians in the community, we remain confident that a significant opportunity for growth remains with the existing indication.

我們已經看到了令人鼓舞的進展。自收購該產品以來，我們顯著降低了患者開始接受治療的平均年齡，並且接受治療的人群數量持續穩定增長。根據與社區醫生的持續討論，我們仍然相信，現有適應症仍有很大的成長機會。

We now have over 100 patients on treatment, and our goal is to reach 120 patients by year-end. So far this year, we have seen the number of patient age outs and closures declined significantly from the level we saw earlier in the fourth quarter of 2025 prior to our last earnings call. Long term, we see a big opportunity in harmonizing the patient definition between the US and the EU.

目前我們有 100 多名患者正在接受治療，我們的目標是在年底達到 120 名患者。今年到目前為止，我們看到患者年齡增長退出和醫院關閉的數量已經比我們在 2025 年第四季度上一次財報電話會議之前看到的水平大幅下降。從長遠來看，我們認為協調美國和歐盟之間的病患定義是一個很大的機會。

In the US, a patient meets the label criteria if their IGF-1 levels are more than three standard deviations below the media. In Europe, where INCRELEX is also available, the definition is 2 standard deviations below the median. And based on the European patient registry data collected over the past 15 years, we believe that INCRELEX is a safe and effective treatment for patients with IGF-1 levels between minus 2 and minus 3 standard deviations.

在美國，如果患者的 IGF-1 水準低於中位數三個標準差以上，則該患者符合標籤標準。在歐洲，INCRELEX 也可用，其定義為低於中位數 2 個標準差。根據過去 15 年收集的歐洲患者登記數據，我們認為 INCRELEX 對於 IGF-1 水平在 -2 到 -3 個標準差之間的患者來說是一種安全有效的治療方法。

We held a meeting with the FDA in December to discuss label harmonization, which we believe was positive. As a result, we submitted the final proposed study protocol to the FDA in February and we expect to receive their feedback either clearance to proceed or comments later this month. Once the FDA signs off, we will initiate the study with our CRO and we expect to see the first patient dose in the third quarter of this year.

我們在 12 月與 FDA 舉行了會議，討論標籤統一問題，我們認為這次會議取得了積極成果。因此，我們在 2 月向 FDA 提交了最終的研究方案草案，我們預計本月稍後會收到他們的回饋，要么批准繼續進行，要么提出意見。一旦獲得 FDA 批准，我們將與我們的 CRO 啟動這項研究，我們預計將在今年第三季看到第一個患者劑量。

Our proposed study is an open-label study of approximately 30 patients tracked for five years or until they reach full adult height with a primary endpoint of change in average annual height velocity at month 12 compared to pretreatment height velocity. Given that it is an open-label study, if the data is as compelling and clear as we expect it to be, we believe there may be an opportunity to approach the FDA with interim data after a couple of years.

我們提出的研究是一項開放標籤研究，追蹤約 30 名患者五年，或直到他們達到完全成年身高，主要終點是第 12 個月平均年身高增長速度與治療前身高增長速度的變化。鑑於這是一項開放標籤研究，如果數據像我們預期的那樣令人信服和清晰，我們相信幾年後或許有機會向 FDA 提交中期數據。

The study is expected to cost approximately $1 million per year. If we are successful with this label harmonization, we believe that the INCRELEX market opportunity could increase fivefold in the United States.

這項研究預計每年耗資約100萬美元。如果我們成功實現標籤統一，我們相信 INCRELEX 在美國的市場機會可能會增加五倍。

Also in our pediatric endocrinology portfolio, we continue to see strong growth from our adrenal insufficiency franchise, ALKINDI SPRINKLE and KHINDIVI.

此外，在我們的兒科內分泌產品組合中，我們的腎上腺功能不全產品線 ALKINDI SPRINKLE 和 KHINDIVI 也持續保持強勁成長。

2025 was ALKINDI's fifth full calendar year on the market and its strongest year yet in terms of number of patients on therapy and number of new patient referrals. This momentum reflects the continued impact of our focused efforts to expand awareness and adoption of pediatric-appropriate hydrocortisone dosing and to reduce friction for both physicians and caregivers making it easier for providers to diagnose, prescribe and initiate therapy for children with adrenal insufficiency.

2025 年是 ALKINDI 上市的第五個完整日曆年，也是迄今為止接受治療的患者人數和新患者轉診人數最多的一年。這一勢頭反映了我們持續努力擴大對兒科適用氫化可的松劑量的認識和採用，並減少醫生和護理人員的摩擦，使醫護人員更容易診斷、開處方和開始治療腎上腺功能不全的兒童，這些努力取得了成效。

KHINDIVI was developed to address the needs of patients that had an aversion to the texture of the ALKINDI granules or who preferred a liquid option. And it is the first and only FDA-approved oral solution of hydrocortisol. Similar to DESMODA, the liquid dosage form laws for mixing and accurate dosing tailored to patient needs and does not require refrigeration mixing or shaking. Together, ALKINDI and KHINDIVI allow us to offer physicians multiple pediatric-appropriate hydrocortisone options, enabling them to choose the formulation that best fits the needs of each child and caregiver.

KHINDIVI 的研發是為了滿足那些不喜歡 ALKINDI 顆粒劑質地或更喜歡液體劑型的患者的需求。它是第一個也是唯一一個獲得 FDA 批准的氫化可的鬆口服溶液。與 DESMODA 類似，液體劑型混合和精確給藥的法律規定可根據患者需求量身定制，無需冷藏、混合或搖晃。ALKINDI 和 KHINDIVI 的結合，使我們能夠為醫生提供多種適合兒科的氫化可的松選擇，使他們能夠選擇最適合每個孩子和護理人員需求的配方。

For our combined franchise, our target market is the estimated 5,000 children under the age of eight in the US with adrenal insufficiency. We believe we have captured around 12% of the market to date, and there is still a long runway ahead of us. Eton remains confident that the franchise can achieve peak annual sales of at least $50 million, which requires only around 20% market share and we ultimately believe that Eton can capture even greater market share if we are accessible in expanding the KHINDIVI label.

對於我們合併後的特許經營權而言，我們的目標市場是美國估計有 5,000 名 8 歲以下患有腎上腺功能不全的兒童。我們相信，到目前為止我們已經佔據了大約 12% 的市場份額，而且我們還有很長的路要走。Eton 仍然相信特許經營店的年銷售額高峰可以達到至少 5,000 萬美元，這只需要大約 20% 的市場份額，我們最終相信，如果我們能夠擴大 KHINDIVI 品牌，Eton 就能獲得更大的市場份額。

KHINDIVI is currently approved for patients five and over, but we believe the largest unmet need is within children under five. The FDA restricted the age due to limited availability on safety data of the three active ingredients when these ingredients are used in combination. However, we've developed a new formulation which substantially lowers levels of these excipients and Eton held a meeting with the FDA in the fourth quarter, where the agency indicated the receptive to a label expansion.

KHINDIVI 目前已獲準用於 5 歲及以上患者，但我們認為最大的未滿足需求在於 5 歲以下兒童。由於缺乏這三種活性成分合併使用時的安全數據，FDA 對年齡進行了限制。然而，我們開發了一種新的配方，大幅降低了這些輔料的含量。 Eton 在第四季度與 FDA 舉行了一次會議，FDA 表示願意擴大標籤範圍。

The agency requested that we run a bioequivalency study and then submit our supplement to the existing NDA. Last week, we dosed the first patient in that bioequivalency study and now plan to submit the supplement as soon as the final study report is available, which we currently expect to be in the third quarter. The FDA indicated the submission would receive a 10-month review aligned for a potential launch by mid-2027.

該機構要求我們進行生物等效性研究，然後提交補充申請以補充現有的新藥申請。上週，我們為該生物等效性研究中的第一位患者進行了給藥，現在計劃在最終研究報告出爐後立即提交補充報告，我們目前預計該報告將在第三季度出爐。FDA表示，該申請將接受10個月的審查，預計到2027年中期可能會上市。

Next, I'd like to discuss our recent acquisition, which we are very excited about. Earlier this month, we announced the acquisition of HEMANGEOL, the only FDA-approved treatment for infantile hemangiomas that require systemic therapy. Infantile hemangiomas are non-cancerous vascular tumors that typically appear shortly after birth and in severe cases, can lead to serious complications including loss of vision, trouble breathing or permanent disfigurement. An estimated 5,000 to 10,000 infants are treated with HEMANGEOL annually in the United States.

接下來，我想談談我們最近完成的收購，我們對此感到非常興奮。本月初，我們宣布收購 HEMANGEOL，這是唯一獲得 FDA 批准用於治療需要全身性治療的嬰幼兒血管瘤的藥物。嬰兒血管瘤是一種非癌性血管腫瘤，通常在出生後不久出現，嚴重時可導致嚴重的併發症，包括失明、呼吸困難或永久性毀容。據估計，美國每年有 5,000 至 10,000 名嬰兒接受 HEMANGEOL 治療。

We've been clear with our acquisition strategy, Eton seeks opportunities where we can meaningfully add value to product. We are unlikely to earn remarkable returns and create value for shareholders if we are purchasing assets only to maintain the status quo of their current level of revenue and earnings.

我們的收購策略已經很明確了，Eton 尋求的是能為產品帶來實質價值的機會。如果我們購買資產只是為了維持其目前的收入和獲利水平，那麼我們不太可能獲得顯著的回報，也不太可能為股東創造價值。

We look for opportunities we're a rare disease company with wide expertise and commercial infrastructure can unlock significant growth and profitability. Similar to how we successfully executed on GALZIN and INCRELEX last year, we believe there is a significant opportunity for value creation with HEMANGEOL.

我們是一家罕見疾病公司，擁有廣泛的專業知識和商業基礎設施，我們正在尋找能夠釋放巨大成長和獲利能力的機會。就像我們去年成功執行 GALZIN 和 INCRELEX 計畫一樣，我們相信 HEMANGEOL 計畫也蘊含著巨大的價值創造機會。

HEMANGEOL had the product characteristics we look for. It treats a rare condition with a small prescriber base. It is the only FDA-approved treatment in its class. It has strong safety and efficacy profile, and there's a meaningful opportunity to improve operational efficiency and margin performance. Our team is hard at work preparing for our May 1 relaunch of the product.

HEMANGEOL具備我們所需的產品特性。它治療的是一種罕見疾病，而開處方的醫生群又很小。它是同類療法中唯一獲得FDA批准的療法。它具有良好的安全性和有效性，並且在提高營運效率和利潤率方面有很大的機會。我們的團隊正在緊鑼密鼓地準備，將於5月1日重新推出該產品。

One of the key opportunities we see is optimizing the product's distribution model with our dedicated rare disease infrastructure and proven go-to-market capabilities. Currently, the product goes through the traditional pharma distribution model, utilizing the large national wholesalers, open pharmacy distribution and significant payer rebating. While this may make sense for higher-volume products, we believe transitioning to our rare disease focused distribution model can significantly lower costs, improve the patient and provider experience and significantly strengthen the long-term economics of the product by reducing gross to net deductions.

我們看到的關鍵機會之一是利用我們專門的罕見疾病基礎設施和成熟的市場推廣能力，優化產品的分銷模式。目前，該產品採用傳統的藥品分銷模式，利用大型全國批發商、開放式藥局分銷和大量的支付方回扣。雖然這對於銷售量較大的產品來說可能有意義，但我們相信，過渡到我們以罕見疾病為中心的經銷模式可以顯著降低成本，改善患者和醫療服務提供者的體驗，並透過減少毛利與淨利之間的扣除額，顯著增強產品的長期經濟效益。

In addition, we will implement our best-in-class Eton Cares patient support program, which we believe will improve the treatment journey for families and expand access to treatment. For instance, we will be offering our standard zero commercial co-pay per patients where today, most patients are paying $55 a month on their co-pay.

此外，我們將實施我們一流的伊頓關懷患者支持計劃，我們相信這將改善家庭的治療過程並擴大治療機會。例如，我們將為每位患者提供標準的零商業自付費用，而目前大多數患者每月需支付 55 美元的自付費用。

HEMANGEOL will also establish a third strategic call point for us. The majority of prescribing occurs within pediatric dermatology, but care for these patients can also involve pediatric hematology oncology physicians who specialize in vascular anomalies. This is a highly concentrated specialty with roughly 400 pediatric dermatologists and a smaller number of specialized pediatric hematology oncology physicians actively managing these patients.

HEMANGEOL也將為我們建立第三個戰略聯絡點。大部分處方都發生在兒科皮膚科，但這些患者的護理也可能涉及專門治療血管畸形的兒科血液腫瘤科醫生。這是一個高度集中的專科，大約有 400 名兒科皮膚科醫生和少數專門治療這些患者的兒科血液腫瘤科醫生。

While we look for other bolt-on opportunities within pediatric dermatology. The HEMANGEOL opportunity is certainly large enough on its own to justify the dedicated commercial efforts. In tandem with the transaction, we are hiring seven new commercial employees that were previously working for the seller and fully dedicated HEMANGEOL.

同時，我們也在尋找其他兒科皮膚病學領域的拓展機會。HEMANGEOL 本身的發展機會就非常巨大，足以證明投入專門的商業努力是值得的。與此交易同步，我們正在招募七名新的商業員工，他們之前為賣方工作，並完全致力於 HEMANGEOL 的發展。

They will start with eaten on April 1, and we are excited to have them joining our organization. This existing team had done an excellent job growing HEMANGEOL in recent years, and we believe their current relationships combined with Eton's rare disease infrastructure, expertise and capabilities will position the product for accelerated momentum following the relaunch in May.

他們將於4月1日開始用餐，我們很高興他們加入我們的組織。近年來，這支現有團隊在發展 HEMANGEOL 方面做得非常出色，我們相信，他們目前的人脈關係，加上 Eton 在罕見疾病領域的基礎設施、專業知識和能力，將使該產品在 5 月重新上市後獲得加速發展。

We were pleased that because of our strong cash flow generation, in 2025, we were able to pay for the $14 million HEMANGEOL acquisition entirely with cash on hand and avoid any dilution or incremental debt. This will make the transaction even more accretive to our earnings. With our ongoing plans to streamline distribution, shrink the gross to net GAAP, optimize revenue and expand access, we believe HEMANGEOL can be one of Eton's largest products in 2027.

我們很高興，由於我們強勁的現金流，在 2025 年，我們能夠完全用手頭現金支付 1400 萬美元的 HEMANGEOL 收購款，避免任何股權稀釋或新增債務。這將使這筆交易對我們的收益產生更大的增益。隨著我們不斷推進分銷通路優化、降低毛利與淨利比率、優化收入和擴大市場覆蓋範圍的計劃，我們相信 HEMANGEOL 預計在 2027 年成為 Eton 最大的產品之一。

Now let me turn to GALZIN, which was another very impressive contributor for the year. When we acquired the product, we expected to be able to grow the product over time, but the product has actually performed well ahead of our expectations. When Eton relaunched in March of 2025, we made major investments into physician education, patient awareness and access support, and those investments are clearly paying off.

現在讓我來談談 GALZIN，它是今年另一家表現非常出色的公司。當我們收購該產品時，期望能夠隨著時間的推移發展壯大該產品，但該產品的實際表現遠遠超出了我們的預期。2025 年 3 月 Eton 重新啟動時，我們對醫生教育、病人意識和就醫支持進行了大量投資，這些投資顯然正在取得成效。

Through Eton Cares, we know that more people than ever are able to access their medication. And we have heard from many patients were previously forced to take non-FDA-approved zinc supplements because they could not afford their co-pay obligations. They are very grateful to now be able to receive the FDA-approved treatment.

透過 Eton Cares 項目，我們知道現在比以往任何時候都有更多的人能夠獲得所需的藥物。我們也了解到，許多患者之前被迫服用未經 FDA 批准的鋅補充劑，因為他們無法負擔自付費用。他們非常感激現在能夠接受FDA核准的治療。

In addition, we have found that many patients and providers were unaware of the availability of GALZIN or we're unaware of the advantages of the prescription product. We have also seen renewed interest from patients and physicians.

此外，我們發現許多患者和醫療服務提供者並不知道 GALZIN 的存在，或不了解這種處方藥的優點。我們也看到了病人和醫生重新燃起的興趣。

Now that we know that Eton Cares will provide patients with access to medication regardless of potential insurance pushback or lack of insurance, physicians can prescribe the product with confidence and not worry that the patient will call them back in a week to complain about high co-pays or looking for alternatives.

既然我們知道 Eton Cares 將為患者提供藥物，無論是否存在保險阻力或缺乏保險，醫生就可以放心地開具該產品，而不必擔心患者會在一周後打電話回來抱怨高額自付費用或尋找替代方案。

The benefit to physicians is twofold.

醫生可以從中獲得雙重好處。

First, they have increased comfort knowing that the FDA approved GALZIN is manufactured to pharmaceutical standards for quality potency and consistency, whereas the over-the-counter products are not.

首先，他們更放心，因為經 FDA 批准的 GALZIN 是按照藥品標準生產的，具有品質、效力和一致性，而非處方產品則不是。

Second, patients taking the prescription product require periodic refills and return visits, so they have much better compliance with follow-up visits and regular lab monitoring and make any needed dose adjustments. Many over-the-counter users end up failing to return for regular visits contributing to worst patient outcomes.

其次，服用處方藥的患者需要定期續藥和復診，因此他們對追蹤和定期實驗室監測的依從性更高，並能進行任何必要的劑量調整。許多非處方藥使用者最終未能按時復診，導致患者治療效果變差。

I am pleased to share that last week, we reached 300 active patients on GALZIN, a big accomplishment just one year after our launch. We still believe there are at least 800 Wilson disease patients in the US taking therapy and potentially over 1,000. So most of the markets still relies on the non-FDA-approved zinc products. We view this as a substantial opportunity for us to potentially more than double our 1,000 patients in the coming years.

我很高興地宣布，上週我們GALZIN的活躍患者人數達到了300人，這是我們在推出該藥物僅一年後取得的巨大成就。我們仍然相信美國至少有 800 名威爾遜病患者正在接受治療，可能有超過 1000 名患者正在接受治療。因此，大多數市場仍然依賴未經 FDA 批准的鋅產品。我們認為這是一個絕佳的機會，讓我們在未來幾年內有可能將患者人數從 1000 人增加一倍以上。

Through our deep collaboration in the Wilson disease community and GALZIN, we have seen the strong desire for an extended release version of GALZIN and ET-700 was developed to address this need. Currently, GALZIN must be taken three times per day with patients fasting both before and after each dose. It's an onerous schedule that can often lead to non-compliance, especially with the middle of the day dose.

透過我們與威爾遜病群體和 GALZIN 的深入合作，我們發現人們對 GALZIN 緩釋版本的強烈需求，因此開發了 ET-700 來滿足這一需求。目前，GALZIN 必須每天服用三次，患者在每次服藥前後均需空腹。這是一個繁瑣的服藥時間表，常常會導致患者不遵守規定，尤其是中午的那劑。

Eton has developed a proprietary patent-pending extended release formula. Our clinical batches have been manufactured, and we are ready to initiate a proof-of-concept positron emission tomography, or PET study, to verify that our proprietary delayed-release formulation can effectively block copper absorption. The study should begin in April, and we expect top-line results later this year.

伊頓公司研發了一種正在申請專利的專有緩釋配方。我們的臨床批次已經生產完成，我們準備啟動概念驗證正子斷層掃描（PET）研究，以驗證我們專有的緩釋配方能否有效阻止銅的吸收。該研究將於四月開始，我們預計今年稍後將公佈初步結果。

If we are successful, we expect to initiate a dose-ranging study and pivotal clinical trial in early 2027. If approved, we are confident that 700 has the potential for more than $100 million of peak annual sales. We've also made strong progress advancing our internal pipeline and in fact, 2026 is set to be by far our busiest year ever in terms of clinical studies.

如果成功，我們預計將於 2027 年初啟動劑量範圍研究和關鍵性臨床試驗。如果獲得批准，我們相信 700 的年銷售高峰有可能超過 1 億美元。我們在推動內部研發方面也取得了顯著進展，事實上，2026 年將是迄今為止我們在臨床研究方面最繁忙的一年。

Eton has already touched on the anticipated studies for KHINDIVI, INCRELEX label harmonization and ET-700 and we also plan to run PK studies on Amglidia and ET-800 later this year. Our goal is to submit the Amglidia NDA by the end of this year and the ET-800 NDA in 2027. So our pipeline for new product launches in the coming years remains very strong.

Eton 已經談到了 KHINDIVI、INCRELEX 標籤協調和 ET-700 的預期研究，我們也計劃在今年稍後對 Amglidia 和 ET-800 進行 PK 研究。我們的目標是在今年年底前提交 Amglidia 的新藥申請，並在 2027 年提交 ET-800 的新藥申請。因此，我們未來幾年推出新產品的計畫依然非常強勁。

Overall, 2025 was a standout year for Eton and we have set the stage for an even stronger 2026, which is reflected in our 2026 financial guidance. We expect 2026 revenue to exceed $110 million and to deliver an adjusted EBITDA margin of at least 3%.

總體而言，2025 年是伊頓公學表現突出的一年，我們為 2026 年的更強勁發展奠定了基礎，這體現在我們的 2026 年財務預期中。我們預計 2026 年營收將超過 1.1 億美元，調整後 EBITDA 利潤率將至少達到 3%。

As we wrap up 2025 and set our plans for 2026, it was a good moment to reflect on how far we've come and where we are headed. A few years ago, I outlined three long-term goals for the company.

在即將結束 2025 年並製定 2026 年計劃之際，這是回顧我們走過的路以及展望未來的好時機。幾年前，我為公司訂定了三個長期目標。

Goal number one to have 10 commercial products. Goal number two, to reach $100 million revenue rate goal number three to reach a $1 billion market cap. At this time, we had just three products when that goal was announced. We had only $20 million of revenue and $100 million market cap. While these goals may have seen miles away from the outside, internally, we have a strong conviction in the opportunity ahead of us, and I believe that these goals were much more attainable than the market perceive them to be.

首要目標是推出10款商業產品。第二個目標是實現 1 億美元的營收，第三個目標是實現 10 億美元的市值。當時，我們只有三款產品，當時就宣布了這個目標。我們當時的收入只有2,000萬美元，市值卻只有1億美元。雖然這些目標在外人看來可能遙不可及，但我們內部對擺在我們面前的機會充滿信心，而且我相信這些目標比市場認為的更容易實現。

I am pleased to share that we have now achieved two of these long-term goals. With the acquisition of HEMANGEOL, we have reached 10 commercial products. And as you have heard, we are expecting more than $100 million of revenue this year. While there is still work to do on the market cap goal, we are confident that if we continue executing our strategy and delivering consistent profitable growth that we expect to achieve, the long-term value creation will be elected in our stock price.

我很高興地告訴大家，我們現在已經達成了其中兩個長期目標。收購 HEMANGEOL 後，我們的商業產品數量已達 10 款。正如你們所聽到的，我們預計今年的收入將超過 1 億美元。雖然距離市值目標還有一段路要走，但我們相信，如果我們繼續執行我們的策略並實現我們預期的持續獲利成長，長期價值創造將體現在我們的股價中。

I believe it's important to keep pushing the organization forward towards ambitious but achievable long-term goals. As a result, we are setting some new long-term goals today.

我認為，推動組織朝著雄心勃勃但又可實現的長期目標不斷前進至關重要。因此，我們今天制定了一些新的長期目標。

First, we want to build the largest rare disease portfolio in the United States. Among the dedicated rare disease companies, we are already near the top in reaching 13 or 14 key commercial products will position Eton as having the largest portfolio of any dedicated rare disease company in the United States. We believe that this is very achievable in the coming years through both our internal pipeline and business development activities.

首先，我們希望在美國建立規模最大的罕見疾病產品組合。在專注於罕見疾病領域的公司中，我們已經接近領先地位，擁有 13 或 14 種關鍵商業產品，這將使 Eton 成為美國專注於罕見疾病領域的公司中擁有最大產品組合的公司。我們相信，在未來幾年內，透過我們的內部人才儲備和業務拓展活動，這是完全可以實現的。

Second, we want to exit 2027 at a $200 million revenue run rate. This requires roughly doubling our revenue over the next -- within the next 24 months, and we see a very realistic path to doing this. Continued growth of ALKINDI, INCRELEX, GALZIN, a successful integration and relaunch of HEMANGEOL, strong launch of DESMODA and the expected launch of KHINDIVI's expanded label in 2027. Plus, we remain confident that we can close at least one more product acquisition that will provide incremental revenue before the end of 2027.

其次，我們希望在 2027 年底達到 2 億美元的營收年化率。這需要我們在未來 24 個月內將收入大致翻一番，而且我們看到了實現這一目標的非常現實的途徑。ALKINDI、INCRELEX、GALZIN 持續成長，HEMANGEOL 成功整合並重新上市，DESMODA 強勢上市，預計 KHINDIVI 的擴展標籤將於 2027 年推出。此外，我們仍然有信心在 2027 年底前完成至少一項產品收購，從而帶來額外的收入。

Third, we want to reach 50% adjusted EBITDA margin in 2028. Profit has always been a central focus of our company. Unlike many of our peers in the industry, we are not pursuing revenue growth at the expense of profitability. We have made continued progress in our profit margins and expect to continue to see improvement as we grow.

第三，我們希望在 2028 年實現 50% 的調整後 EBITDA 利潤率。獲利一直是本公司的核心目標。與業內許多同業不同，我們不會以犧牲獲利能力為代價來追求收入成長。我們的利潤率持續提高，隨著公司的發展，預計利潤率將繼續改善。

Our adjusted EBITDA margins first turned positive from product sales in 2024 when we reported an 8% margin, they grew to 20% in 2025, and we expect to be over 30% this year. With continued revenue growth, we expect to see the benefits of operating leverage that can drive us to 50% EBITDA margins in the coming years. With our existing base of commercial and operational infrastructure as well as our products continuing to grow and an outside portion of growth should fall to the bottom line.

我們的調整後 EBITDA 利潤率在 2024 年首次由產品銷售轉正，當時利潤率為 8%，2025 年增長至 20%，我們預計今年將超過 30%。隨著營收的持續成長，我們預計未來幾年內，營運槓桿效應將推動我們實現 50% 的 EBITDA 利潤率。憑藉我們現有的商業和營運基礎設施基礎以及我們產品的持續成長，外部成長的一部分應該會轉化為利潤。

Our fourth and final goal is to reach a $500 million worth of revenue by 2030. Again, we believe that this is an achievable goal through our three-pillar growth strategy.

我們的第四個也是最後一個目標是到 2030 年達到 5 億美元的收入。我們再次相信，透過我們的三大支柱成長策略，這是可以實現的目標。

First, our existing portfolio has strong organic growth prospects. This includes INCRELEX, ALKINDI, KHINDIVI, GALZIN, DESMODA. All of these products have achieved just a fraction of the market share that we think they can reach in the years ahead.

首先，我們現有的投資組合具有強勁的內生成長前景。其中包括 INCRELEX、ALKINDI、KHINDIVI、GALZIN、DESMODA。所有這些產品目前所佔的市場份額都只是我們認為它們在未來幾年能夠達到的市場份額的一小部分。

Second, our existing pipeline has several large programs that could add significant revenue by 2030. This was ET-700, which we believe is peak revenue potential well in excess of $100 million annually on its own. Plus our INCRELEX label expansion opportunity Amglidia, ET-800 and other programs in development that we have not yet announced.

其次，我們現有的產品線中有幾個大型項目，到 2030 年有望帶來可觀的收入。這就是 ET-700，我們認為它本身的年收入潛力高峰將遠遠超過 1 億美元。此外，我們還有 INCRELEX 品牌擴展機會 Amglidia、ET-800 和其他正在開發中的項目，這些項目我們尚未公佈。

And finally, we will layer on more business development deals. We believe we have proven our ability to close, integrate and create significant value through acquisitions, and we begin -- and we expect to sign more deals like INCRELEX, GALZIN, HEMANGEOL, which will further boost our revenue in the years to come.

最後，我們將增加更多業務拓展交易。我們相信，我們已經證明了我們有能力透過收購完成交易、整合業務並創造重大價值，而且我們已經開始——我們期待簽署更多像 INCRELEX、GALZIN、HEMANGEOL 這樣的交易，這將在未來幾年進一步提高我們的收入。

It's clear that we've come a long way over the last few years, but I truly believe that we are just getting started. We have found a proven winning strategy, assemble the right team, accumulated a diversified portfolio of growing products and build an attractive pipeline to fuel long-term growth. We're in the best addition we've ever been.

很明顯，過去幾年我們取得了長足的進步，但我真心相信我們才剛起步。我們找到了行之有效的致勝策略，組建了合適的團隊，累積了多元化的成長型產品組合，並建立了有吸引力的產品線，以推動長期成長。我們正處於有史以來最好的發展階段。

Thank you for your continued support, and we look forward to keeping you updated on our price developments in the months and the years ahead.

感謝您一直以來的支持，我們將在未來的幾個月和幾年持續向您通報我們的價格動態。

With that, I'll hand it over to James, our Chief Financial Officer, to discuss the financials. James?

接下來，我將把發言權交給我們的財務長詹姆斯，讓他來討論財務狀況。詹姆斯？

Thank you, Sean. Our fourth-quarter revenue increased 83% to $21.3 million compared to $11.6 million in the fourth quarter of 2024 and revenue was comprised entirely of product sales in both periods. Revenue growth in the quarter was driven primarily by increased sales of ALKINDI SPRINKLE plus the addition of sales from INCRELEX, GALZIN and KHINDIVI. As we discussed previously, our third-quarter revenue included a meaningful contribution from INCRELEX outside the US tie to the transition of that business to a new licensing partner.

謝謝你，肖恩。與 2024 年第四季的 1,160 萬美元相比，我們第四季的營收成長了 83%，達到 2,130 萬美元，這兩個時期的營收都完全由產品銷售構成。本季營收成長主要得益於 ALKINDI SPRINKLE 的銷售額增加，以及 INCRELEX、GALZIN 和 KHINDIVI 的銷售額成長。正如我們之前討論過的，由於 INCRELEX 在美國以外的業務過渡到新的授權合作夥伴，我們第三季的收入做出了重大貢獻。

Looking strictly at US product sales. Our revenue grew sequentially by 8% in the fourth quarter relative to the third quarter. We expect our reported total revenue to resume sequential quarterly growth in the first quarter of 2026 and continue to ramp throughout the year. Cost of sales for the fourth quarter was $8.2 million compared to $5.2 million in the fourth quarter of 2024.

僅考慮美國產品銷售情況。第四季我們的營收季增了 8%，高於第三季。我們預計，2026 年第一季度，我們的報告總收入將恢復環比成長，並在全年持續成長。第四季的銷售成本為 820 萬美元，而 2024 年第四季的銷售成本為 520 萬美元。

Adjusted gross profit, which adjusts for the impact of acquired inventory step-up adjustments and intangible amortization, was $15.5 million in the fourth quarter of 2025 or 73% compared to adjusted gross profit of $6.8 million and 59% in the prior-year period. The margin improvement was driven by favorable product mix as well as manufacturing cost efficiencies as the products grow.

經調整後的毛利（已調整收購存貨增值調整和無形資產攤銷的影響）在 2025 年第四季為 1,550 萬美元，年增 73%，而上年同期經調整後的毛利為 680 萬美元，年增 59%。利潤率的提高得益於有利的產品組合以及隨著產品成長而帶來的製造成本效率的提高。

HEMANGEOL and DESMODA are both expected to have margin profiles well above our store company average so they should be positive contributors to future gross margins. We still see a slightly lower adjusted gross margin profile in early 2026, due to margin dilutive orders of INCRELEX outside the US as our licensing partner ramps up their distribution efforts in more countries. But on a full-year basis, we expect adjusted gross margin to be comfortably above 70%, and this margin is expected to continue to ramp and reach between 75% and 80% in the coming years.

HEMANGEOL 和 DESMODA 的利潤率預計都將遠高於我們門市公司的平均水平，因此它們應該會對未來的毛利率做出積極貢獻。由於我們的授權合作夥伴在更多國家加大分銷力度，導緻美國以外地區的 INCRELEX 訂單稀釋了利潤，我們預計 2026 年初的調整後毛利率將略有下降。但從全年來看，我們預計調整後的毛利率將輕鬆超過 70%，並且預計這一毛利率將在未來幾年繼續增長，達到 75% 至 80% 之間。

R&D expenses for the quarter were $1.8 million, an increase of $2.7 million compared to negative $0.9 million in the prior-year period due primarily to increased expenses associated with our development activities. In addition, during the fourth quarter of 2024, Eton's ET-400 product was granted orphan drug designation by the FDA, which resulted in Eton receiving a $2.0 million refund of the NDA filing fee that was paid and expensed in a prior quarter.

本季研發費用為 180 萬美元，比上年同期的負 90 萬美元增加了 270 萬美元，主要是由於與我們的研發活動相關的費用增加所致。此外，在 2024 年第四季度，Eton 的 ET-400 產品獲得了 FDA 的孤兒藥資格認定，這使得 Eton 獲得了 200 萬美元的 NDA 申請費退款，該費用已在前一季度支付併計入支出。

R&D expense for 2026 will depend on the timing and final protocol of the numerous studies that we have planned for this year, and we believe it will likely increase from the $7.8 million in 2025 but will remained below $10 million for 2026.

2026 年的研發費用將取決於我們今年計劃進行的眾多研究的時間安排和最終方案，我們認為它可能會比 2025 年的 780 萬美元有所增加，但 2026 年仍將低於 1000 萬美元。

General and administrative expenses for the quarter were $8.9 million compared with $6.7 million in the prior-year period primarily due to increased promotional and launch-related investments associated with the expansion of our product portfolio, an increase in compensation and benefit expenses due to increased general and administrative head count and an increase in FDA program fees. On an adjusted basis, which removes the impact of share-based compensation, transaction-related costs and other onetime expenses, G&A expense was $7.8 million compared to $5.8 million in the prior-year period.

本季一般及行政費用為 890 萬美元，而上年同期為 670 萬美元，主要原因是與產品組合擴張相關的推廣和上市投資增加、一般及行政人員數量增加導致薪酬和福利支出增加以及 FDA 項目費用增加。經過調整後（剔除了股份支付、交易相關成本和其他一次性費用的影響），一般及行政費用為 780 萬美元，而去年同期為 580 萬美元。

We have talked extensively about the onetime increase of additional investments made in 2025 and support our long-term growth, driving increased spending in SG&A. However, we are pleased that the increased G&A investment was substantially less than our growth in revenue.

我們已經廣泛討論了 2025 年一次性增加的額外投資，以支持我們的長期成長，從而推動銷售、一般及行政費用的增加。然而，我們感到欣慰的是，增加的行政管理費用遠低於我們的收入成長。

One of the factors driving increased G&A spend is the FDA's annual program fees. For all NDA products, the FDA charges a program fee each year. The FDA grants an exemption for products that have orphan designations if the parent company has gross sales of less than $50 million. Eton has previously received these exemptions and thus avoided the fees.

導致一般及行政開支增加的因素之一是 FDA 的年度計畫費用。對於所有 NDA 產品，FDA 每年都會收取項目費。如果母公司的總銷售額低於 5,000 萬美元，FDA 將對獲得孤兒藥資格認定的產品給予豁免。伊頓公學之前曾獲得這些豁免，因此避免了繳納學費。

However, starting with the October 1, 2025 annual program fees, Eton no longer qualified for an exemption. For the FDA's fiscal year 2026, the annual program fee is $442,000 per strength for NDA products. As of October 25, when the annual fee was assessed, Eton had eight unique strengths for a total annual fee of $3.5 million.

然而，從 2025 年 10 月 1 日起，伊頓公學的年度課程費用不再符合豁免資格。對於 FDA 2026 財年，NDA 產品的年度專案費用為每種規格 442,000 美元。截至 10 月 25 日評估年度費用時，伊頓公學擁有八項獨特的優勢，年度總費用為 350 萬美元。

This annual fee is prepaid on October 1 and for accounting purposes, the expense is amortized throughout the year. As a result, $0.9 million was recorded as an SG&A expense in Q4 of 2025. These program fees are estimated to drive an incremental $2.8 million increase in SG&A spend for 2026 over 2025.

這項年費於 10 月 1 日預付，出於會計目的，該費用將在一年內攤提。因此，2025 年第四季計入了 0.9 億美元銷售、管理及行政費用。據估計，這些項目費用將使 2026 年的銷售、一般及行政費用比 2025 年增加 280 萬美元。

Regarding overall SG&A spending for 2026, we have two main growth drivers: FDA program fees and HEMANGEOL. The FDA program fees are estimated to add an incremental $2.8 million expense over 2025 and the HEMANGEOL acquisition is expected to add approximately $3.5 million in annualized SG&A spend and about $2.5 million in the partial-year 2026. Separately from those two onetime step-ups, we believe that our base SG&A spending would have increased by less than 10% in 2026.

關於 2026 年的整體 SG&A 支出，我們有兩個主要的成長驅動因素：FDA 計畫費用和 HEMANGEOL。預計 FDA 專案費用將在 2025 年增加 280 萬美元的額外支出，而 HEMANGEOL 的收購預計將在 2026 年部分年度增加約 350 萬美元的銷售、管理及行政支出，並增加約 250 萬美元。撇開這兩項一次性成長不談，我們認為到 2026 年，我們的基本銷售、一般及行政費用支出將成長不到 10%。

Adjusted EBITDA for the fourth quarter of 2025 was $6.2 million or 29% of revenue compared to $2.1 million or 18% of revenue in the fourth quarter of 2024. Again, adjusted EBITDA will likely see large fluctuations quarter to quarter depending on the timing of inconsistent R&D expenses and ex-US INCRELEX orders, but we expect the full-year adjusted EBITDA margin to be above 30%.

2025 年第四季調整後 EBITDA 為 620 萬美元，佔營收的 29%，而 2024 年第四季調整後 EBITDA 為 210 萬美元，佔營收的 18%。再次強調，調整後的 EBITDA 可能會因研發費用和美國以外 INCRELEX 訂單的時間安排而出現季度間大幅波動，但我們預計全年調整後的 EBITDA 利潤率將超過 30%。

Total company GAAP net income was $1.5 million for the quarter compared to a net loss of $0.6 million in the prior-year period. Net income per basic and diluted share during the quarter was $0.06 and $0.05, respectively, compared to a net loss per basic and diluted share of $0.02 in the prior-year period.

本季公司總GAAP淨收入為150萬美元，而去年同期淨虧損為60萬美元。本季每股基本淨收益和每股攤薄淨收益分別為 0.06 美元和 0.05 美元，而去年同期每股基本淨虧損和每股攤薄淨虧損分別為 0.02 美元。

On a non-GAAP basis, we reported net income of $5.4 million for the fourth quarter of 2025 compared to $0.7 million in the prior-year period. and diluted earnings per share of $0.19 for the fourth quarter of 2025 compared to $0.02 per share in the prior-year period.

以非GAAP準則計算，我們報告2025年第四季淨利為540萬美元，而上年同期為70萬美元；2025年第四季稀釋後每股收益為0.19美元，而去年同期為每股0.02美元。

Eton finished the fourth quarter with $25.9 million of cash on hand. We had an operating cash outflow of $11.6 million in Q4 of 2025 compared to an operating cash inflow of $12.0 million in the previous quarter. The fourth quarter included $12.4 million of Medicaid rebate payments as multiple quarters' worth of INCRELEX rebates were paid in Q4, $3.5 million of the aforementioned FDA program fees and $1.4 million of inventory payments associated with the onetime transition of ex-US INCRELEX distribution in Europe.

伊頓公司第四季末現金餘額為2590萬美元。2025 年第四季度，我們的經營現金流出為 1,160 萬美元，而上一季的經營現金流入為 1,200 萬美元。第四季包括 1,240 萬美元的 Medicaid 退款支付，因為 INCRELEX 的多個季度退款在第四季度支付；350 萬美元的上述 FDA 項目費用；以及 140 萬美元的庫存付款，與 INCRELEX 在美國境外分銷到歐洲的一次性過渡有關。

Looking forward, we expect to generate significant operating cash flow throughout 2026 and beyond.

展望未來，我們預計在 2026 年及以後將產生可觀的經營現金流。

This concludes our remarks on fourth-quarter results. And with that, I'll turn it back over to the operator for Q&A.

以上就是我們對第四季業績的評論。接下來，我將把問答環節交還給接線員。

(Operator Instructions) Chase Knickerbocker, Craig Hallum.

（操作說明）蔡斯·尼克博克，克雷格·哈勒姆。

Congrats on all the progress here. A lot to get to. But maybe just first on HEMANGEOL. You mentioned that, that could be one of your largest products in 2027 that implies quite a lot of growth from kind of the roughly $12 million in 2025 sales.

恭喜你們取得的所有進展。有很多事情要做。但或許應該先在 HEMANGEOL 上試試。您提到，這可能是您 2027 年最大的產品之一，這意味著與 2025 年約 1,200 萬美元的銷售額相比，將有相當大的成長。

Can you walk us through your assumption on how the assumptions on how the product gets there? What do you think from a volume perspective? And then what does that assume as far as any actions on price or gross to net improvements?

能詳細解釋一下你對產品如何實現的假設嗎？從銷售角度來看，你覺得怎麼樣？那麼，這對於價格或毛利/淨利的改善措施意味著什麼？

This is Sean. Thanks for the question. we believe we will increase the number of patients on product, partly that zero co-pay was preventing a lot of patients using the product that are previously had a higher co-pay amount and went to other alternatives. So we think that's part of it. That will certainly drive more patient adoption.

這是肖恩。感謝您的提問。我們相信，使用該產品的患者人數將會增加，部分原因是零自付費用先前阻礙了許多自付費用較高的患者使用該產品，他們轉而選擇了其他替代方案。所以我們認為這是其中的一部分原因。這無疑會促進更多患者接受治療。

We will be raising awareness working with the efficacy groups and certainly detailing the product that are much more aggressive level. We want to use that word, but to we want to be able to reach out and make sure that all the patients that can use a product, we'll get the product.

我們將與功效團體合作，提高大眾意識，並詳細介紹那些功效較強的產品。我們想使用這個詞，但我們也想能夠聯繫到所有可能使用該產品的患者，確保他們都能獲得該產品。

And in terms of the pricing, we haven't made any final decisions on that. We'll launch it on May 1, and we'll see where we end up on that.

至於定價方面，我們還沒有做出最終決定。我們將於5月1日正式上線，看看最終效果如何。

But our philosophy has always been to be at the lower end of rare disease pricing. And so as a general rule, that's our approach. And it's largely based upon how many patients are out there and making sure that the pricing is competitive with the rare disease products out.

但我們的理念始終是，將罕見疾病藥物的定價控制在較低水準。所以，總的來說，這就是我們的做法。這主要取決於有多少患者，以及確保定價與市面上其他罕見疾病產品具有競爭力。

Got it. And maybe just on DESMODA on kind of how you see the pace to peak, the value proposition is pretty similar to kind of the idea behind KHINDIVI. You obviously know all these physicians already selling to multiple assets. How do you kind of think about the time to peak sales as far as being potentially quicker here because of those dynamics?

知道了。或許就 DESMODA 而言，你認為它達到頂峰的速度與 KHINDIVI 背後的理念非常相似。你顯然知道這些醫生已經將資產出售給了多家公司。您認為由於這些因素，銷售高峰期的到來時間可能會更快嗎？

Well, I don't know if I could comment too much on the time of peak sales, right? The launch has gone well. We're very pleased. We're getting scripts continuously. Doctors are very excited about the product.

嗯，關於銷售高峰期，我不太好多評論，對吧？發布會進行得很順利。我們非常滿意。我們不斷收到腳本。醫生們對這款產品非常興奮。

I will say, I believe the launch to peak sales will be far quicker than what we had in ALKINDI. This is a very specific unmet need. Obviously, ALKINDI, an unmet need in a bit of a different way. But unlike ALKINDI, there were not a lot of compounders out there, compounding desmopressin.

我認為，從上市到銷售高峰，這款產品的發展速度將遠超過我們在ALKINDI所取得的成就。這是一個非常具體的未被滿足的需求。顯然，ALKINDI 滿足的是一種略有不同的未被滿足的需求。但與 ALKINDI 不同的是，當時並沒有很多配製去氨加壓素的藥劑師。

So doctors are thrilled to have the product. We know that the uptake has been right according to the plan and not better. So I would say that it faster. We guided to that $30 million to $50 million hoping we're well on our way there in six months or so.

因此，醫生們對這款產品非常滿意。我們知道，目前的銷售情況符合計劃，而且沒有超出預期。所以我覺得它速度更快。我們預計目標金額為 3,000 萬至 5,000 萬美元，希望在六個月左右的時間內能夠順利實現這一目標。

Got it. And maybe just last kind of two-parter here. Maybe just one for James on how you see cash flow conversion from EBITDA in 2026?

知道了。或許這是最後一部由兩部分組成的劇集了。或許可以問 James 一個問題，你如何看待 2026 年 EBITDA 轉化為現金流的情況？

And then, Sean, just kind of lastly, on that $200 million run rate exiting 2027. Could you kind of delineate between what might come through BD and kind of how you see the existing portfolio today kind of performing to get to that run rate at the end of 2017?

最後，肖恩，就最後說說到 2027 年底 2 億美元的年收入目標吧。您能否具體說明一下，透過 BD 可能會出現的情況，以及您認為現有投資組合在 2017 年底達到預期收益水準所需的表現？

Sure. Yeah. Sure. James, well, I can take the first part.

當然。是的。當然。詹姆斯，嗯，我可以做第一部分。

Sure. We try to give some context on the Q3, Q4 cash flow at the end of 2025. 2026 will firmly be in positive operating cash flow territory. We do have -- we will have some timing commitments, namely with INCRELEX that will plan for the second half of the year.

當然。我們嘗試對 2025 年底第三季和第四季的現金流量情況進行一些分析。 2026 年將穩步實現正的經營現金流。我們確實有一些時間安排上的承諾，特別是與 INCRELEX 的合作，他們將製定下半年的計劃。

In the first half of the year, there should be not nearly as much as we experienced in Q3 of 2021. But some of the larger larger-than-average volume with study orders in Europe for INCRELEX. But other than that, we are firmly in positive operating capital territory. We will start making debt principal payments, which will be new in 2026 versus 2025, but even with that, we'll be generating a lot of positive cash flow.

今年上半年，情況應該不會像 2021 年第三季那麼糟糕。但歐洲一些研究訂單的數量遠遠超過平均水平，用於研究 INCRELEX。但除此之外，我們的營運資本完全處於正值區間。我們將從 2026 年開始償還債務本金，這與 2025 年的情況不同，但即便如此，我們仍將產生大量的正現金流。

Okay. And then, Chase, regarding your question on the $200 million run rate. As you know, and as I think we've demonstrated throughout our the history of our company, we generally set goals which are achievable. We believe the $200 million run rate in the Q4 of next year is entirely achievable primarily based on what we have on deck. This doesn't really include new product deals, licensing that type of thing.

好的。然後，Chase，關於你提出的 2 億美元運行率的問題。如您所知，而且我認為我們在公司發展歷程中也已經證明了這一點，我們通常會設定可實現的目標。我們相信，明年第四季實現 2 億美元的營收目標完全可以實現，這主要基於我們目前已有的計畫。這並不包括新產品交易、授權許可之類的事情。

We believe that HEMANGEOL will be a great product for the company. We believe DESMODA will continue to grow quickly. We're seeing higher sales than ever on and ALKINDI and KHINDIVI. Those continue to increase. We're very pleased with the INCRELEX business and how that grows and it's been nice because we haven't lost as many -- the older patients, and now we're gaining momentum and going forward on that, that's been solid. And really all areas of the business are functioning well.

我們相信 HEMANGEOL 將成為公司的優秀產品。我們相信DESMODA將持續快速成長。我們看到 ALKINDI 和 KHINDIVI 的銷量比以往任何時候都高。這些數字還在持續增加中。我們對 INCRELEX 業務及其發展非常滿意，而且令人欣慰的是，我們沒有流失太多老年患者，現在我們正在獲得發展勢頭，並且將繼續保持這種勢頭，這方面進展順利。事實上，公司各個業務領域都運作良好。

There's a lot of growth prospects in the coming quarters in terms of the revenue and hitting the $200 million run rate in Q4 next year, I think, is entirely achievable. We will be providing further updates on future conference calls to try to better ascertain what's the number what can it be and that type of thing.

未來幾個季度，公司營收將有很大的成長前景，我認為明年第四季達到 2 億美元的年化營收目標完全可以實現。我們將在以後的電話會議上提供更多最新消息，以便更好地確定具體數字是多少，以及可能是什麼等等。

Madison El-Saadi, B. Riley Securities.

Madison El-Saadi，B. Riley Securities。

Congrats on a lot of positive updates here. Maybe to follow up on DESMODA. It sounds like you're having interest both de novo and from existing. Could you kind of characterize if the majority of interest is from the existing ALKINDI population and how much of it is de novo? Also curious if you're seeing already some adult patient interest?

恭喜這裡有很多正面的進展。或許可以跟進DESMODA計畫。聽起來你既對新項目感興趣，也對現有項目感興趣。您能否大致說明一下，大部分興趣來自現有的 ALKINDI 群體，又有多少是新發現的？另外，我很好奇您是否已經看到一些成年患者對此感興趣？

And then secondly, on INCRELEX, as you prepare for this registry study, just wondering if you had any payer discussions regarding potential internal payer reimbursements for the registry patients, if that something that's possible?

其次，關於 INCRELEX，在您準備進行這項註冊研究時，我想知道您是否與支付方討​​論過註冊患者的潛在內部支付方報銷問題，如果這是有可能的？

Sure, Matt. So I'm going to have pack our Chief Commercial Officer, answer the first part of your question with regards to DESMODA and the pediatric versus adult.

當然可以，馬特。所以我要請我們的商務長來回答你關於 DESMODA 以及兒科與成人的問題的第一部分。

Madison, it's Ipek. So for -- I think you're right from our script, more than 97% -- 97%, 98% of our existing relationships. The pediatric anthology are actually the -- our target subscribers for central diabetes antivirus, which is for DESMODA. So these relationships are already there from the day one of launch, which was March 9, our team was already talking to these physicians. There's a lot of excitement from key riders, salt leaders, big institutions already in the past two weeks.

麥迪遜，是伊佩克。所以——我認為你從我們的腳本來看是對的，超過 97%——97%，98% 的現有關係。兒科選集實際上是我們針對糖尿病中心抗病毒藥物（即 DESMODA）的目標訂閱者。因此，從產品發布第一天（3月9日）起，這些關係就已經存在了，我們的團隊當時就已經開始與這些醫生溝通。過去兩週，主要騎手、鹽業領導人物和大型機構都表現出了極大的熱情。

What we are excited about is call points that our team traditionally have not gone after maturity adult anthologies like Sean mentioned. It is we gave our team two weeks ago when we launched the product, more than 3,000 new targets, and they just started going after those. We've talked to soften actually, who are big in the adult space. Some of them actually end up still keeping the pediatric patients. So they definitely see a role in it as a right therapy for several adult patients as well.

我們感到興奮的是，我們團隊傳統上沒有涉足的領域，例如像肖恩提到的成熟成人選集。兩週前我們推出產品時，為團隊設定了 3000 多個新目標，他們就開始朝著這些目標努力了。我們已經和 Softful 實際上談過了，他們在成人領域很有影響力。有些醫院最後還是繼續收治兒科病人。所以他們認為這種療法對許多成年患者來說也是適當的治療方法。

And they also see the pediatric patients based on the region and institutions. So there is definitely a dual pet opportunity that is incremental to our existing relationships there.

他們也會根據地區和醫療機構接診兒科患者。因此，這絕對是一個可以與我們現有關係相輔相成的雙寵物機會。

And remind me the second part of your question?

請提醒我你問題的第二部分是什麼？

And then on INCRELEX, if there's been any early payer to related to --

然後，關於 INCRELEX，如果之前有任何早期付款方與此相關的話。--

Yeah, the payer discussions haven't happened because we feel it would be any different. If we get the label expansion, there shouldn't be any issues with payers right now. If a doctor has even prescribe something off like from time to time due to a medical need and can demonstrate that there will be reimbursement.

是的，我們沒有和付款方討論，因為我們覺得結果不會有什麼不同。如果我們能獲得標籤擴展許可，目前應該不會有支付方方面面的問題。如果醫生偶爾因為醫療需求而開立處方，並且能夠證明可以獲得報銷。

But generally speaking, what we want to do is initiate that study as soon as possible. That protocol feedback should happen by the end of this month. And I am quite confident that we will be undertaking the study later this year as -- and obviously, it's going to have a huge impact on our acrylic sales. We are hoping that when we're -- portion of that way into the study is open label, we can go to the agency and get that label updated as soon as possible.

但總的來說，我們希望盡快啟動這項研究。該協議的回饋結果應該在本月底前給出。我非常有信心，我們將在今年稍後進行這項研究，因為——很顯然，這將對我們的壓克力銷售產生巨大影響。我們希望，當研究進行到一定階段（部分研究是開放標籤階段）時，我們可以盡快向監管機構申請更新標籤。

RK, H.C. Wainright.

RK，H.C. Wainright。

This is RK from H.C. Wainright. Good afternoon, Sean and James. So I mean, obviously, there's a lot of things to chew here and all good stuff.

這是來自 H.C. Wainright 的 RK。下午好，肖恩和詹姆斯。所以我的意思是，很明顯，這裡有很多東西值得思考，而且都是好東西。

In terms of the ongoing business, especially focusing on GALZIN, you said you have already eclipsed 300 active patients at this point. And then within -- still about 500 remaining out there and possibly on OTC products.

就目前的業務而言，特別是針對 GALZIN，您提到目前活躍患者人數已超過 300 人。還有大約 500 例仍在市面上流通，可能可以透過非處方藥購買。

What portion of that is achievable in the immediate couple of quarters? And how much of that are you how much contribution of that are you assuming going into 2027 when you're trying to hit that $50 million per quarter on the fourth quarter?

其中有多少可以在接下來的幾個季度內實現？那麼，當你試圖在 2027 年第四季實現每季 5000 萬美元的目標時，你預計這其中有多少貢獻？

Thanks, RK, for the question. We obviously did the 300 patients much faster than we had expected that continues to increase week over week.

謝謝RK的提問。顯然，我們完成 300 名患者的治療速度比預期快得多，而且這個數字還在每週持續成長。

I'm going to ask Ipek actually to comment a little bit more on the second part.

我打算請伊佩克就第二部分再多發表一些看法。

RK, I think your diagnosis of the fact that the next chapter of growth needing to come from the OTC products is correct. We -- the good part is we -- in Wilson disease space, obviously, the centers of excellence are pretty established. And at this point, after a year into launch, we have pretty strong relationships and ongoing initiatives with several of these centers of excellent thought leaders and the top prescribers.

RK，我認為你關於下一階段成長需要來自非處方藥產品的診斷是正確的。好消息是，在威爾遜氏症領域，顯然，卓越中心已經相當完善了。時至今日，經過一年的發展，我們已經與其中幾個匯聚了傑出思想領袖和頂級處方醫生的中心建立了相當牢固的關係，並開展了持續的合作項目。

So we do know where some of these patients, some of that population is. I think based on our projections, I am confident to say within that timeframe that you mentioned, we will be able to get to half of that remaining population out there who are on therapy or some form that is not FDA approved between everything that we are doing in the field with these prescribers as well as the awareness and education initiatives that we are closely working on with the Wilson Disease Association, which is the key patient advocacy group and really, a lot of patients are very much in sync and present in that community as of this community.

所以我們知道其中一些患者，或者說這部分人群在哪裡。我認為根據我們的預測，我可以自信地說，在您提到的時間範圍內，我們將能夠幫助剩餘人群中的一半，這些人正在接受未經 FDA 批准的治療或療法。這得益於我們與這些處方醫生在實地進行的所有工作，以及我們與威爾遜病協會（主要的患者權益倡導組織）密切合作開展的宣傳和教育活動。事實上，很多患者都非常積極地參與這個群體。

Great. So my next question is on the label expansions or the indication expansions that you're trying to achieve. One is on the INCRELEX. What specific feedback do you need from the FDA at this point in terms of harmonizing the definition of SPIGFD and to get your study going?

偉大的。所以我的下一個問題是關於您想要實現的標籤擴展或指示擴展。其中一輛在 INCRELEX 上。目前，您需要 FDA 提供哪些具體回饋，以統一 SPIGFD 的定義並啟動您的研究？

And the second part is on the KHINDIVI 1, if the patient population gets increased successfully below 85%, what sort of population are we assuming that you will have access to?

第二部分是關於 KHINDIVI 1 的，如果患者人數成功增加到 85% 以下，我們假設您將能夠接觸到什麼樣的人群？

Sure. On the INCRELEX, we've already received feedback from the agency on that. We took the feedback and put that in the formula protocol. So they send you feedback at the general letter, they say we want to see this and this and this. then you formalize that in a scientific protocol that takes a number of weeks, then you submit it to the agency.

當然。關於 INCRELEX，我們已經收到了該機構的回饋。我們採納了回饋意見，並將其納入了方案流程中。所以他們會以一般信函的形式給你回饋，說他們想看到這個、那個和那個。然後你需要把這些內容整理成一份科學方案，這需要幾週時間，然後再提交給相關機構。

They then should look at that, make sure that they feel you incorporate their thoughts and comments. And hopefully, when we get it back, there's few or no changes. If that's the case, which it should be, unless they change their mind, then our belief is we can start to study. We hope to have that protocol back by the end of this month. So that's that one.

然後他們應該查看這些內容，確保他們覺得你採納了他們的想法和意見。希望當我們取回它時，幾乎沒有任何變化。如果情況真是如此（除非他們改變主意，否則應該如此），那麼我們認為我們可以開始學習了。我們希望在本月底前恢復該協議。就這一個吧。

And then regarding the KHINDIVI formulation, we're -- well we should have that wrapped up the seat here shortly, get it submitted in the third, fourth quarter -- maybe third quarter, I'm guessing third quarter submission and then it will launch next year. The population, it's really intended for under 5%. That's really what the whole product was about. We believe -- I believe it will do an excess $20 million of additional revenue rather short quarter.

至於 KHINDIVI 配方，我們應該很快就能搞定，在第三、第四季提交——我猜是第三季提交，然後明年就會推出。人口，實際上是指不到 5% 的人口。這才是整個產品的核心。我們相信——我相信它將在短短一個季度內帶來超過 2000 萬美元的額外收入。

Okay. And then the last question is on the inventory burn off. How much is on the remaining inventory step-up from the Ipsen acquisitions and to be fully amortized through the P&L?

好的。最後一個問題是關於庫存消耗的。收購 Ipsen 而產生的剩餘庫存增值部分有多少需要在損益表中完全攤銷？

Yeah, very little. There will be a slight amount remaining in early 2026, but a small fraction, we burned through most of it in 2025.

是的，很少。到 2026 年初還會剩下少量，但只是很小一部分，我們在 2025 年就用掉了大部分。

And that is all the time we have for Q&A today and does conclude today's conference call. Thank you for participating. You may now disconnect.

今天的問答環節到此結束，今天的電話會議也到此結束。感謝您的參與。您現在可以斷開連線了。