Eton Pharmaceuticals Inc (ETON) 2026 Q1 法說會逐字稿

Good afternoon, and welcome to the Eton Pharmaceuticals first-quarter 2026 financial results conference call.

各位下午好，歡迎參加 Eton Pharmaceuticals 2026 年第一季財務業績電話會議。

(Operator Instructions)

（接線員指示）

Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn it over to David Krempa, Chief Business Officer at Eton Pharmaceuticals. Please proceed.

請注意，應公司要求，本次電話會議將被錄音。此刻，我想把電話交給 Eton Pharmaceuticals 首席商務官 David Krempa。請開始。

Thank you, operator. Good afternoon, everyone, and welcome to Eton's first-quarter 2026 conference call. This afternoon, we issued a press release that outlines the topics we plan to discuss on today's call. The release is available on our website, etonpharma.com.

謝謝，接線員。各位下午好，歡迎參加 Eton 2026 年第一季電話會議。今天下午，我們發布了一則新聞稿，概述了我們計畫在今天電話會議中討論的主題。該新聞稿可於我們的網站 etonpharma.com 查閱。

Joining me on our call today, we have Sean Brynjelsen, our CEO; James Gruber, our CFO; Judy Matthews, our Executive Vice President of Finance; and Ipek Trinkaus, our Chief Commercial Officer.

今天與我一同參與電話會議的有：我們的執行長 Sean Brynjelsen；財務長 James Gruber；財務執行副總裁 Judy Matthews；以及首席商務長 Ipek Trinkaus。

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

除了在今天的電話會議中接受即時提問外，我們也會回答以電子郵件寄給我們的問題。投資人可將問題寄至 etonpharma.com 的投資人關係信箱。在開始之前，我想提醒各位，本次電話會議中的發言可能包含前瞻性陳述，涉及風險與不確定性，可能導致實際結果與這些前瞻性陳述所述內容存在重大差異。請參閱我們盈餘新聞稿中的前瞻性陳述免責聲明，以及公司向 SEC 提交文件中的風險因素。現在我將把電話交給我們的執行長 Sean Brynjelsen。

Thank you, David. Good afternoon, everyone, and thank you for joining us today. The first-quarter was another great quarter for Eton. We achieved record product sales delivering 73% year-over-year product revenue growth. We launched two new major products, DESMODA and HEMANGEOL.

謝謝你，David。各位下午好，感謝今天加入我們。第一季對 Eton 而言又是一個非常出色的季度。我們達成創紀錄的產品銷售，產品營收年增 73%。我們推出了兩項新的重要產品：DESMODA 與 HEMANGEOL。

And we made great strides advancing our R&D programs with the achievement of several development milestones. We will discuss all of these items and more on the call today. On the quarterly results, it was another great quarter for Eton with $24 million in product sales, an increase of 73% year-over-year.

同時，我們在推進研發（R&D）計畫方面也取得重大進展，達成多項開發里程碑。我們將在今天的電話會議中討論上述事項及更多內容。就季度業績而言，Eton 再次交出亮眼成績，產品銷售額達 2,400 萬美元，年增 73%。

Our growth continues to be driven by contributions across the product portfolio, including INCRELEX, ALKINDI, GALZIN and Carglumic Acid, highlighting the diversification and durability of our rare disease portfolio. This impressive revenue growth did not even include the benefit of the product launches of DESMODA and HEMANGEOL since they launched in mid-March and May, respectively.

我們的成長持續來自整體產品組合的貢獻，包括 INCRELEX、ALKINDI、GALZIN 與 Carglumic Acid，突顯我們罕見疾病產品組合的多元化與持久性。值得注意的是，這項亮眼的營收成長甚至尚未納入 DESMODA 與 HEMANGEOL 產品上市所帶來的效益，因為它們分別於 3 月中旬與 5 月才上市。

Based on the outperformance in the first-quarter and the trends we are seeing midway through the second-quarter, I'm pleased to report that we are raising our full year revenue guidance. We now expect revenue to exceed $120 million, up from our previous guidance of $110 million. Importantly, we delivered this notable first-quarter revenue growth in a highly profitable manner.

基於第一季的超預期表現，以及我們在第二季進行到一半時所觀察到的趨勢，我很高興宣布我們上調全年營收指引。我們目前預期營收將超過 1.2 億美元，高於先前指引的 1.1 億美元。更重要的是，我們以高度獲利的方式實現了第一季顯著的營收成長。

We grew product revenue by 73%, but G&A spending increased by only 14% year-over-year on a GAAP basis and 22% on a non-GAAP basis. The majority of the G&A increase was due to increased costs of FDA annual program fees now that we no longer qualify for the orphan PDUFA exemption rather than the true increases in our discretionary spend.

我們的產品營收成長 73%，但一般及行政（G&A）支出在 GAAP 基礎下僅年增 14%，在非 GAAP 基礎下年增 22%。G&A 增加的主要原因，是由於我們不再符合孤兒藥 PDUFA 豁免資格，因此 FDA 年度計畫費用成本上升，而非我們可自行裁量支出的實質增加。

Adjusted EBITDA for the quarter was $5.7 million or 24% of revenue. We continue to expect to achieve a greater than 30% adjusted EBITDA margin for the full year and believe we are on track to reach our goal of a 50% adjusted EBITDA margin by 2028. The results are a testament to the effectiveness and scalability of our unique rare disease model and infrastructure.

本季調整後 EBITDA 為 570 萬美元，約占營收的 24%。我們仍預期全年可達成超過 30% 的調整後 EBITDA 利潤率，並相信我們正朝著 2028 年達成 50% 調整後 EBITDA 利潤率的目標邁進。這些成果證明了我們獨特的罕見疾病模式與基礎設施的有效性與可擴展性。

Our nimble proven infrastructure has allowed us to launch two new products in 2026 so far without a significant increase in expenses and without impacting the execution of growth in our existing portfolio. We expect to see similar trends in the coming quarters as we continue to quickly grow revenue and bring to market new rare disease therapies.

我們靈活且經驗證的基礎設施，使我們在 2026 年迄今已推出兩項新產品，卻未顯著增加費用，也未影響既有產品組合的成長執行。我們預期在接下來幾季將看到類似趨勢，因為我們將持續快速提升營收並將新的罕見疾病療法推向市場。

Turning to product specifics. I will start with our exciting new launch of HEMANGEOL, which took place just a matter of days ago. HEMANGEOL is the only FDA-approved treatment for infantile hemangiomas, which are noncancerous vascular tumors that appear shortly after birth and can sometimes lead to serious complications, including loss of vision, trouble breathing, or permanent disfigurement.

接著談到各產品的具體情況。我將先從我們令人振奮的 HEMANGEOL 新上市開始，該產品就在幾天前剛完成上市。HEMANGEOL 是唯一獲 FDA 核准用於治療嬰兒血管瘤（infantile hemangiomas）的療法；嬰兒血管瘤是出生後不久出現的非癌性血管腫瘤，有時可能導致嚴重併發症，包括視力喪失、呼吸困難或永久性毀容。

HEMANGEOL treatment is typically initiated as soon as an infant is diagnosed, which is usually before six months of age, and patients normally stay on treatment for approximately six months. HEMANGEOL is a remarkable product with impressive efficacy and clinically proven safety.

HEMANGEOL 的治療通常在嬰兒被診斷後即刻開始，而診斷通常發生在 6 個月大之前；患者一般會接受約 6 個月的治療。HEMANGEOL 是一項卓越的產品，具備令人印象深刻的療效與經臨床證實的安全性。

The results are often life-changing for patients and their families. If you have not done so, I encourage you to search for before-and-after photos of severe infantile hemangiomas treated with HEMANGEOL to gain some perspective on how dramatic the results can be. With HEMANGEOL, we saw an opportunity to add meaningful value to an important treatment by, among other things, streamlining therapy access and distribution and improving patient support.

其結果往往能為患者及其家庭帶來改變人生的影響。如果您尚未這麼做，我建議您搜尋使用 HEMANGEOL 治療嚴重嬰兒血管瘤的治療前後照片，以更直觀地了解療效可能有多麼顯著。透過 HEMANGEOL，我們看到了為一項重要治療帶來實質價值的機會，其中包括精簡治療取得與配送流程，以及改善患者支持等。

HEMANGEOL is a time-sensitive treatment and we're dedicated to helping patients start therapy quickly and supporting families from the moment of prescription through treatment. HEMANGEOL expanded Eton into a third therapeutic area, pediatric dermatology, and importantly, brought an incredibly experienced team into the organization that was already promoting HEMANGEOL.

HEMANGEOL 是一項具時間敏感性的治療，我們致力於協助患者快速開始治療，並自開立處方起一路支持家庭直到完成療程。HEMANGEOL 也使 Eton 擴展至第三個治療領域——兒科皮膚科；更重要的是，將一支原本就負責推廣 HEMANGEOL、且經驗極其豐富的團隊納入組織。

This team has spent nearly a decade supporting physicians, families and patients within this community and have built deep, long-standing relationships focused on helping children access HEMANGEOL. One of the things we were most excited about in this acquisition was the opportunity to combine that experience and commitment to patients with Eton's rare disease commercialization model and patient support infrastructure.

這支團隊近十年來一直在此社群中支持醫師、家庭與患者，並建立了深厚且長期的關係，專注於協助兒童取得 HEMANGEOL。我們在此次收購中最感到興奮的一點，是有機會把他們的經驗與對患者的承諾，與 Eton 的罕見疾病商業化模式及患者支持基礎設施結合。

We believe Eton's focused rare disease approach, including Eton Cares, high-touch patient support, specialty pharma infrastructure and our no-patient-left-behind philosophy will further strengthen the work this team has already been doing for years on behalf of patients and families. We have already implemented several changes that we believe will improve the therapy experience for patients and providers and add value, including we have streamlined the distribution, shifting to a rare disease-focused model that reduces fragmentation and improves visibility and efficiency during the patient's journey.

我們相信 Eton 專注的罕見疾病策略，包括 Eton Cares、高接觸式患者支持、專科製藥（specialty pharma）基礎設施，以及我們「不讓任何患者被遺漏」的理念，將進一步強化這支團隊多年來為患者與家庭所做的工作。我們已經實施了數項變更，並相信這些變更將改善患者與醫療提供者的治療體驗並創造價值；其中包括我們已精簡配送流程，轉向以罕見疾病為核心的模式，以降低流程碎片化，並在患者旅程中提升可視性與效率。

Under the prior structure, prescriptions could move across multiple pharmacies and intermediaries, which often created confusion for providers and families around where prescriptions were located, who was responsible for fulfilment and how to resolve access issues quickly.

在先前的架構下，處方可能會在多家藥局與中介機構之間流轉，這往往使醫療提供者與家庭對處方位於何處、由誰負責配藥（fulfilment），以及如何快速解決取得藥品的問題感到困惑。

Secondly, we have launched our full Eton Cares patient support program, including streamlined $0 co-pay support for commercially insured patients and expanded patient assistance programs for uninsured and underinsured families. Previously, many families were paying approximately $55 per bottle, and in some cases, more than $100 per month depending on dosing and coverage, while access to co-pay support and financial assistance was often fragmented and difficult for offices and families to navigate.

第二，我們已推出完整的 Eton Cares 患者支持計畫，包括為具商業保險的患者提供精簡的 0 美元自付額（$0 co-pay）支持，並為無保險與保險不足的家庭擴大患者援助計畫。過去，許多家庭每瓶約需支付 55 美元，而在某些情況下，依劑量與保險給付而定，每月甚至超過 100 美元；同時，自付額支持與財務援助的取得往往零散且不易讓診所與家庭順利操作。

Third, we are already building upon the strong physician relationships the team developed over many years and are taking the next step in expanding engagement with thought leaders, professional societies and broader healthcare provider education initiatives to further increase awareness, education and appropriate patient identification within the treatment window.

第三，我們已在團隊多年建立的強大醫師關係基礎上持續深化，並進一步擴大與意見領袖、專業學會及更廣泛的醫療提供者教育倡議的互動，以在治療時窗內進一步提升認知、教育與適當的患者辨識。

And lastly, we are actively engaging with the patient advocacy community around HEMANGEOL and are increasing our investment in long-term commitment to advocacy partnerships, caregiver education and community support initiatives. Our goal is not simply to support the therapy itself but to become a more active and visible partner to the broader patient community through meaningful engagement, education, and resources.

最後，我們正積極與圍繞 HEMANGEOL 的病友倡議社群互動，並加大對倡議合作夥伴關係、照護者教育與社群支持倡議之長期承諾的投資。我們的目標不僅是支持該療法本身，更是透過有意義的互動、教育與資源，成為更廣泛病友社群中更積極且更具能見度的合作夥伴。

The responses from advocacy organizations and professional society partners have been incredibly positive, them welcoming Eton's commitment to expanding patient support, access resources, and long-term investment in the community. Historically, we believe there has been significant usage of off-label adult propranolol formulations that are approved for cardiovascular indications. These adult formulations contain alcohol, sugar and other preservatives that are not suitable for infants.

倡議組織與專業學會合作夥伴的回饋極為正面，他們歡迎 Eton 致力於擴大病患支持、取得資源，以及對社群的長期投資。從歷史上看，我們認為已核准用於心血管適應症的成人普萘洛爾（propranolol）製劑，存在大量的超適應症（off-label）使用。這些成人製劑含有酒精、糖及其他防腐劑，並不適合嬰兒。

By contrast, HEMANGEOL, which is the only FDA-approved treatment for infantile hemangiomas, was formulated specifically for infants without containing alcohol or sugar. During our due diligence, we found that the primary reasons for the -- using off-label adult product were, one, the fact that the adult product had a lower co-pay than the $55 HEMANGEOL co-pay; and two, a lack of awareness among parents and prescribers about the alcohol and other excipients that are present in the adult formulation.

相較之下，HEMANGEOL 是唯一獲 FDA 核准用於嬰兒血管瘤（infantile hemangiomas）的治療藥物，其配方專為嬰兒設計，不含酒精或糖。在我們的盡職調查中，我們發現使用超適應症成人產品的主要原因有二：第一，成人產品的自付額（co-pay）低於 HEMANGEOL 的 55 美元自付額；第二，家長與處方醫師對成人配方中含有酒精及其他賦形劑（excipients）的認知不足。

We have addressed the co-pay issue with our $0 co-pay program, and we plan to address the awareness issue through our investments and efforts in new campaigns targeted at both prescribers and caregivers. There are still many variables and uncertainties involved with the launch.

我們已透過 0 美元自付額計畫解決自付額問題，並計畫透過投資與推動新的宣導活動，針對處方醫師與照護者雙方來解決認知不足的問題。此次上市仍涉及許多變數與不確定性。

However, our preliminary view is that between our free drug patient assistance program, government patients and certain commercial payer contracts we inherited, we estimate that around 60% to 65% of the volume may be near zero revenue, which should result in an estimated average net price per patient of around $8,000 to $10,000 for a full course of therapy.

不過，我們初步認為，結合我們的免費用藥病患協助計畫、政府給付病患，以及我們承接的部分商業保險支付方合約，我們估計約 60% 至 65% 的用量可能接近零營收，這應會使每位病患完成一個完整療程的估計平均淨價約為 8,000 至 10,000 美元。

Of course, this is a preliminary estimate and a number of factors such as patient mix could cause the actual number to differ materially. We should have more precise insight by our next earnings call in August, and we'll update you accordingly.

當然，這只是初步估算，且病患組合等多項因素可能導致實際數字出現重大差異。我們應可在 8 月的下一次財報電話會議前獲得更精確的洞見，並將相應更新各位。

While it is a massive undertaking to get thousands of patients transferred from a broad distribution to a new single pharmacy in such a short period, our team has been preparing and working hard to complete it quickly and ensure that the process is as smooth as possible for families and prescribers. We're still early in HEMANGEOL's launch -- relaunch, I should say, but we have experienced cooperation from certain prior dispensing pharmacies, which we believe will help the situation in the transition.

雖然要在如此短的時間內，將數千名病患從廣泛的配送體系轉移至新的單一藥局是一項龐大的工程，但我們的團隊一直在準備並努力工作，以快速完成轉移，並確保對家庭與處方醫師而言流程盡可能順暢。我們仍處於 HEMANGEOL 上市——更準確地說是重新上市——的早期階段，但我們已獲得部分先前配藥藥局的合作，我們相信這將有助於過渡期間的轉換。

HEMANGEOL's revenue contribution to second-quarter results is expected to be limited. Since it is launching mid-quarter, it may take several weeks or months to get patients fully transferred to the new pharmacy. We expect to start seeing a sizable revenue contribution beginning in the third-quarter.

HEMANGEOL 對第二季業績的營收貢獻預期將有限。由於在季度中期啟動上市，病患完全轉移至新藥局可能需要數週或數月。我們預期自第三季開始將看到顯著的營收貢獻。

And while it is still too early in the launch to say definitively, since there are a number of variables yet to play out, we believe that HEMANGEOL could be our largest product in 2027. Eton also launched DESMODA during the first-quarter, shortly after its FDA approval. As the first and only FDA-approved desmopressin oral solution, DESMODA is a game-changer for patients because it eliminates the need to split or crush tablets, allowing for very precise dosing.

此外，雖然目前仍處於上市初期，尚無法下定論，因為仍有多項變數有待發展，但我們相信 HEMANGEOL 可能在 2027 年成為我們最大的產品。Eton 也在第一季於獲得 FDA 核准後不久推出 DESMODA。作為首個且唯一獲 FDA 核准的去氨加壓素（desmopressin）口服溶液，DESMODA 對病患而言是一項改變遊戲規則的產品，因其免除分割或碾碎錠劑的需求，並可進行非常精準的劑量給藥。

Thought leaders in the community have described DESMODA as potentially transformative, given how individualized desmopressin dosing is from patient to patient and even with -- in the same patient over time throughout their treatment journey. Historically, patients and providers have often had reliance on suboptimal workarounds using tablets, nasal sprays, injections, none of which are designed to provide the combination of oral administration and precise flexible dose titration that many patients require.

社群中的意見領袖將 DESMODA 形容為可能具有變革性，因為去氨加壓素的劑量在不同病患之間高度個別化，甚至同一位病患在其治療旅程中，隨時間推移也會有所不同。過去，病患與醫療提供者往往依賴以錠劑、鼻噴劑、注射等方式進行不理想的替代作法，而這些方式都不是為了同時提供口服給藥與許多病患所需的精準且彈性的劑量滴定（titration）而設計。

During our March earnings call, we were just a few weeks into the DESMODA launch, but I shared that I was encouraged by what I saw. I'm pleased to say the excitement level has continued in April and thus far in May. I am proud of our operations and commercial teams' exceptional launch plan and execution, and I believe that it was the best executed product launch in Eton's history and sets a new standard for future product launches.

在我們 3 月的財報電話會議時，DESMODA 上市才剛過幾週，但我分享我對所見感到鼓舞。我很高興地表示，4 月以及截至目前 5 月的熱度仍在延續。我為我們營運與商業團隊卓越的上市規劃與執行感到自豪，我相信這是 Eton 歷史上執行得最好的產品上市，並為未來的產品上市樹立了新標準。

Since day one of the launch, peer-to-peer education efforts have complemented targeted field engagement across key accounts supporting early awareness and clinical dialogue. In parallel, Eton has had strong opportunities to engage with thought leaders at national and regional conferences.

自上市第一天起，同儕對同儕（peer-to-peer）的教育推廣便與針對重點客戶的現場互動相輔相成，支持早期認知建立與臨床對話。同時，Eton 也在全國性與區域性會議上，獲得與意見領袖互動的良好機會。

Earlier this month, our team attended two of the most important endocrinology conferences of the year: the Pediatric Endocrinology Nursing Society, and Pediatric Endocrine Society annual meetings. The timing was very favourable, coming in the midst of our DESMODA launch, and our team was able to take advantage of the opportunity to engage with hundreds of leading pediatric endocrinology prescribers of DESMODA. Importantly, the feedback was overwhelmingly positive.

本月稍早，我們的團隊參加了年度兩個最重要的內分泌學會議：小兒內分泌護理學會（Pediatric Endocrinology Nursing Society）與小兒內分泌學會（Pediatric Endocrine Society）年會。時機非常有利，正值我們 DESMODA 上市期間，我們的團隊得以把握機會，與數百位 DESMODA 的頂尖小兒內分泌處方醫師交流。重要的是，回饋幾乎一面倒地正面。

We believe the launch has also opened doors to important institutions that historically could be difficult to access, creating broader opportunities for meaningful dialogue not only around DESMODA, but across the rest of our pediatric endocrinology portfolio, including ALKINDI, INCRELEX and KHINDIVI. We believe the impact of these engagements will continue to build in the coming weeks and months.

我們相信，此次上市也為我們打開了與重要機構合作的大門，而這些機構過去在接觸上可能較為困難，從而創造更廣泛且有意義的對話機會，不僅圍繞 DESMODA，也涵蓋我們其餘的小兒內分泌產品組合，包括 ALKINDI、INCRELEX 與 KHINDIVI。我們相信這些互動的影響將在未來數週與數月持續累積。

DESMODA fulfils a very specific need, and we've seen an enthusiastic reception from prescribers. DESMODA is being promoted by the same team of pediatric endocrinology rare disease specialists who promote ALKINDI, KHINDIVI and INCRELEX. So far, the product launch is meeting my high expectations and we continue to believe it could reach peak sales of $30 million to $50 million.

DESMODA 滿足一項非常特定的需求，我們已看到處方醫師熱烈的反應。DESMODA 由同一支推廣小兒內分泌罕見疾病的專業團隊進行推廣，該團隊同時推廣 ALKINDI、KHINDIVI 與 INCRELEX。迄今為止，產品上市表現符合我很高的期待，我們仍相信其峰值銷售額可達 3,000 萬至 5,000 萬美元。

Turning to the rest of our commercial products. The story remains consistent with that of the last few quarters. We continue to see strong, steady growth from across our diversified portfolio. INCRELEX, ALKINDI SPRINKLE and GALZIN all provided major growth contributions in the quarter.

接著談我們其餘的商業化產品。整體故事與過去幾季一致。我們持續看到多元化產品組合帶來強勁且穩健的成長。INCRELEX、ALKINDI SPRINKLE 與 GALZIN 在本季皆提供了主要的成長貢獻。

As we have discussed before, we believe we have captured relatively small share of the market opportunity for all three of these key growth products. So we continue to believe that they have long runways for growth ahead of them. On the R&D side of Eton, we have made strong progress advancing our pipeline and achieved a number of critical milestones in recent months.

如同我們先前討論過的，我們認為在這三項關鍵成長產品上，我們目前僅取得相對較小的市場機會份額。因此，我們仍相信它們未來仍有很長的成長跑道。在 Eton 的研發方面，我們在推進產品管線上取得了強勁進展，並在近幾個月達成多項關鍵里程碑。

First, on INCRELEX, the label harmonization program, I am pleased to share that we now have received the FDA's clearance to proceed with our proposed clinical study. We intend to initiate the study in the second half of this year. The study will track approximately 30 patients over 5 years or until they reach full adult height with a primary endpoint of change in average annual height velocity at month 12 compared to pretreatment height velocity. As we've discussed extensively, we see a significant opportunity to expand the potential patient population by harmonizing the US definition of severe primary IGF-1 deficiency to match that of Europe.

首先，在 INCRELEX 方面，關於標籤一致化（label harmonization）計畫，我很高興分享我們現已獲得 FDA 核准可依我們提出的臨床研究方案繼續推進。我們計畫在今年下半年啟動該研究。研究將追蹤約 30 名病患，為期 5 年或直到其達到完全成人身高；主要終點為第 12 個月的平均年度身高生長速度相較於治療前身高生長速度的變化。如同我們已廣泛討論的，我們看到一個顯著機會：透過使美國對嚴重原發性 IGF-1 缺乏（severe primary IGF-1 deficiency）的定義與歐洲一致，來擴大潛在病患族群。

If we are successful with harmonizing the label, we believe the INCRELEX market opportunity could increase fivefold in the United States. On ET-700, our extended-release zinc acetate, we announced that a pilot study has been initiated to test the efficacy of ET-700 relative to GALZIN and placebo in a double-blinded placebo-controlled clinical trial comprised of 36 healthy volunteers.

如果我們成功完成標籤一致化（harmonizing the label），我們相信 INCRELEX 在美國的市場機會可能增加五倍。關於 ET-700（我們的緩釋型醋酸鋅），我們宣布已啟動一項先導研究，在一項雙盲、安慰劑對照的臨床試驗中（共納入 36 名健康志願者），測試 ET-700 相較於 GALZIN 與安慰劑的療效。

PET scans with radioactive tracer copper will compare the effects on intestinal copper absorption of GALZIN taken 3 times daily, ET-700 taken twice daily plus a placebo taken daily as well. And a placebo also, I'm sorry, taken 3 times daily. The study treatment will last four weeks, and we expect to have the top line results in the second half of 2026.

使用放射性示蹤銅的 PET 掃描將比較腸道銅吸收的影響：GALZIN 每日服用 3 次；ET-700 每日服用 2 次，並另外每日服用一次安慰劑。以及安慰劑，抱歉，是每日服用 3 次。研究治療將持續四週，我們預期在 2026 年下半年取得主要（top line）結果。

If early results are positive, they could lead to a pivotal clinical study in early 2027. We believe ET-700 could exceed $100 million of annual peak sales in the United States once it's approved. On our KHINDIVI label expansion program, where we are seeking to expand the FDA-approved range of the label beyond the current label of ages five and up, we are wrapping up final patient dosing in our bioequivalency study and expect to have results in the next couple of months.

若早期結果正向，可能在 2027 年初推進至關鍵性臨床研究。我們相信 ET-700 一旦獲批，在美國的年度峰值銷售額可超過 1 億美元。關於我們的 KHINDIVI 標籤擴展計畫，我們正尋求將 FDA 核准的標籤適用年齡範圍擴大至目前「5 歲以上」之外；我們正在完成生體相等性研究的最後一批病人給藥，並預期在接下來幾個月內取得結果。

If successful, that will allow us to file our supplemental filing to the existing NDA in the third-quarter and potentially receive approval in the second-quarter of 2027. We have continued to see tepid uptake of KHINDIVI with its current restrictive label and believe the extended label will be the catalyst to see greater adoption.

若成功，將使我們得以在第三季向既有 NDA 提交補充申請（supplemental filing），並有機會在 2027 年第二季獲得核准。我們持續看到 KHINDIVI 在目前受限標籤下的採用偏溫和（tepid），並相信延伸後的標籤將成為推動更高採用率的催化劑。

In addition, we progressed Amglidia, our oral liquid glyburide program, for the treatment of neonatal diabetes. Amglidia is approved and widely used in Europe but has not been approved in the United States. Currently, there are no FDA-approved treatments for neonatal diabetes, so it represents a critical unmet need. Amglidia is a perfect strategic fit for us. It treats an extremely rare condition impacting only a few hundred patients in the United States, and it is prescribed by pediatric endocrinologists.

此外，我們推進 Amglidia（我們的口服液體格列本脲 glyburide 計畫），用於治療新生兒糖尿病。Amglidia 已在歐洲獲批並廣泛使用，但尚未在美國獲批。目前美國尚無任何 FDA 核准的新生兒糖尿病治療，因此這代表一項關鍵的未被滿足醫療需求。Amglidia 與我們的策略高度契合。它治療的是一種極罕見疾病，在美國僅影響數百名病患，且由小兒內分泌科醫師開立處方。

Two characteristics that we specialize in here at Eton. We recently filed an IND with the FDA, which should allow us to initiate the required bioavailability study by July of this year. Based on our current timelines, we expect to submit the product's NDA in the fourth-quarter, which would give us the potential to deliver a high-value product launch in 2027. As you've heard this afternoon, it's been a great start to the year, and we're well positioned for an exceptional 2026. The momentum from our existing products remains strong.

這正是我們 Eton 所擅長的兩項特徵。我們近期已向 FDA 提交 IND，這應可讓我們在今年 7 月前啟動所需的生體可用率研究。依據目前時程，我們預期在第四季提交該產品的 NDA，這將使我們有機會在 2027 年推出一項高價值產品上市。正如各位今天下午所聽到的，今年開局非常好，我們也已為卓越的 2026 年做好準備。既有產品帶來的動能依然強勁。

We've added two additional high-value product launches. We're meaningfully adding and advancing our pipeline to fuel long-term growth. And as always, we're continuing to pursue acquisition opportunities to expand our portfolio and add incremental revenue while maintaining our disciplined approach to operating expenses. Based on the strong performance in Q1, I believe we remain on track to reach the following forward long-term goals I outlined in March. Number one, build the largest, rare disease portfolio in the United States.

我們新增了兩項額外的高價值產品上市。我們正實質性地擴充並推進研發管線，以驅動長期成長。同時，一如既往，我們持續尋求併購機會，以擴大產品組合並增加增量營收，同時維持對營運費用的紀律性管理。基於第一季的強勁表現，我相信我們仍按計畫朝我在 3 月提出的以下前瞻性長期目標邁進。第一，在美國打造最大的罕見疾病產品組合。

Two, reach a $200 million annual revenue run rate by end of 2027. Three, achieve a 50% adjusted EBITDA margin profile in 2028. And fourth, reach $500 million of annual revenue in 2030. Thank you for your ongoing support, and we look forward to keeping you apprised of the many exciting milestones ahead. Before I turn it over to James for the final time, I'd like to take a moment to personally thank him for his contributions and dedication to the organization over the last four years.

第二，在 2027 年底前達到年化營收 run rate 2 億美元。第三，在 2028 年達成 50% 的調整後 EBITDA 利潤率結構。第四，在 2030 年達到年營收 5 億美元。感謝各位持續的支持，我們也期待持續向各位更新未來許多令人振奮的里程碑。在我最後一次把時間交給 James 之前，我想花點時間親自感謝他在過去四年對組織的貢獻與投入。

He's done an exceptional job leading our finance department during a period of rapid growth as we grew from 2 to 10 commercial products in short order. Thank you, James, for all you've done on behalf of Eton. On June 1, Judy Matthews will take over as CFO. Judy joined us last month as Executive Vice President of Accounting and Finance and has been quickly getting caught up to speed on our business. Judy previously led finance departments of high-growth pharmaceutical companies, and we're excited to have her on board.

在我們快速成長的期間，他出色地領導財務部門，讓我們在短時間內將商業化產品從 2 項擴增到 10 項。James，感謝你代表 Eton 所做的一切。6 月 1 日起，Judy Matthews 將接任 CFO。Judy 上個月加入我們，擔任會計與財務執行副總裁，並迅速熟悉我們的業務。Judy 先前曾領導高成長製藥公司的財務部門，我們很高興她加入團隊。

With that, I'll turn it over to James to discuss the financial results. James?

接下來，我把時間交給 James 來說明財務結果。James？

Thank you, Sean. first-quarter revenue increased 40% to $24.3 million compared to $17.3 million in the first-quarter of 2025, and we had $3.3 million of licensing revenue in the first-quarter of 2025. Product sales and royalty revenue were $24.3 million during the quarter compared to $14.0 million in the prior year period, an increase of 73%, driven by strong growth across the portfolio, in particular INCRELEX, ALKINDI SPRINKLE, GALZIN and Carglumic Acid, as well as from the addition of sales from KHINDIVI, which was approved and launched in mid-2025.

謝謝你，Sean。第一季營收較 2025 年第一季的 1,730 萬美元增加 40% 至 2,430 萬美元；而 2025 年第一季我們有 330 萬美元的授權（licensing）收入。本季產品銷售與權利金收入為 2,430 萬美元，較去年同期的 1,400 萬美元增加 73%，主要受惠於產品組合的強勁成長，尤其是 INCRELEX、ALKINDI SPRINKLE、GALZIN 與 Carglumic Acid，並且也來自 KHINDIVI 的新增銷售貢獻；KHINDIVI 於 2025 年年中獲批並上市。

Gross profit for the quarter was $14.7 million compared with $9.9 million in the prior year period, an increase of 49%, primarily due to increased product sales. Adjusted gross profit, which adjusts for the impact of acquired inventory step-up adjustments and intangible amortization, was $16.2 million in the first-quarter of 2026 or 67% of revenue compared to adjusted gross profit of $12.0 million and 69% of revenue in the prior year period.

本季毛利為 1,470 萬美元，較去年同期的 990 萬美元增加 49%，主要由產品銷售增加所帶動。調整後毛利（Adjusted gross profit）會排除收購存貨公允價值調整（step-up adjustments）與無形資產攤銷的影響；2026 年第一季調整後毛利為 1,620 萬美元，約占營收 67%，相較去年同期調整後毛利 1,200 萬美元、約占營收 69%。

First-quarter of 2026 included revenue from INCRELEX sales outside the US which was dilutive to gross margin. We continue to expect to deliver full year 2026 adjusted gross margin of at least 70% and reach between 75% and 80% in the coming years. HEMANGEOL and DESMODA are both expected to have gross margin profiles well above our historic company average.

2026 年第一季包含 INCRELEX 在美國以外地區的銷售收入，對毛利率具有稀釋（dilutive）效果。我們仍預期 2026 全年調整後毛利率至少達到 70%，並在未來幾年提升至 75% 至 80%。HEMANGEOL 與 DESMODA 的毛利率結構預期都將顯著高於我們公司過往的平均水準。

R&D expenses for the quarter were $1.9 million, an increase of $0.7 million compared to $1.2 million in the prior year period, primarily due to higher clinical study expenses associated with the KHINDIVI label expansion and ET-700 development activities. We continue to expect full year 2026 R&D spending to be above last year's $7.8 million but less than $10 million.

本季研發（R&D）費用為 190 萬美元，較去年同期的 120 萬美元增加 70 萬美元，主要因 KHINDIVI 標籤擴展與 ET-700 開發活動相關的臨床研究費用較高。我們仍預期 2026 全年研發支出將高於去年的 780 萬美元，但低於 1,000 萬美元。

General and administrative expenses for the quarter were $10.4 million compared with $9.2 million in the prior year period. On an adjusted basis, which removes the impact of share-based compensation, transaction-related costs and other onetime expenses, G&A expense was $9.0 million compared to $7.3 million in the prior year period.

本季一般與行政（G&A）費用為 1,040 萬美元，較去年同期的 920 萬美元增加。以調整後口徑（排除股份基礎給付、交易相關成本及其他一次性費用的影響）計算，G&A 費用為 900 萬美元，較去年同期的 730 萬美元增加。

The largest driver of the increase was higher FDA annual program fees since Eton no longer qualifies for the orphan PDUFA exemption as we now exceed the revenue threshold required to qualify. These fees were responsible for $0.9 million of the year-over-year G&A increase. The remaining increase was largely due to incremental headcount to support the growing portfolio.

增加的最大驅動因素是 FDA 年度計畫費用上升，因為 Eton 目前已不再符合孤兒藥 PDUFA 豁免資格，原因是我們現在的營收已超過取得資格所需的門檻。這些費用造成 G&A 年增增加中的 90 萬美元。其餘增加主要來自為支援不斷擴大的產品組合而新增的人力編制。

Adjusted EBITDA for the first-quarter of 2026 was $5.7 million or 24% of revenue compared to $3.7 million or 21% of revenue in the first-quarter of 2025, which had the benefit of licensing revenue. Our adjusted EBITDA will likely see fluctuations quarter-to-quarter depending on the timing of R&D expenses and ex USNCRELEX orders, but we expect the full year adjusted EBITDA margin to be above 30%.

2026 年第一季的調整後 EBITDA 為 570 萬美元，約占營收的 24%，相較於 2025 年第一季的 370 萬美元（約占營收的 21%）；2025 年第一季受惠於授權收入。我們的調整後 EBITDA 可能會因研發費用與美國以外 USNCRELEX 訂單的時點而在各季間波動，但我們預期全年調整後 EBITDA 利潤率將高於 30%。

Total company net income was $1.6 million for the quarter compared to a net loss of $1.6 million in the prior year period. Net income per basic and diluted share during the quarter was $0.06 and $0.05, respectively, compared to a net loss per basic and diluted share of $0.06 in the prior year period.

本季公司整體淨利為 160 萬美元，相較於去年同期淨損 160 萬美元。本季基本與稀釋每股淨利分別為 0.06 美元與 0.05 美元，相較於去年同期基本與稀釋每股淨損均為 0.06 美元。

On a non-GAAP basis, we reported net income of $4.5 million for the first-quarter of 2026 compared to $2.4 million in the prior year period and diluted earnings per share of $0.14 for the first-quarter of 2026 compared to $0.07 per share in the prior year period. In the first-quarter, we generated $7.4 million in cash flow from operations, paid $14 million for HEMANGEOL and finished the quarter with $19.7 million of cash on hand.

以非 GAAP 基礎計算，我們 2026 年第一季淨利為 450 萬美元，相較於去年同期的 240 萬美元；2026 年第一季稀釋每股盈餘為 0.14 美元，相較於去年同期每股 0.07 美元。第一季我們自營運活動產生 740 萬美元現金流，支付 1,400 萬美元用於 HEMANGEOL，並以 1,970 萬美元的現金餘額結束本季。

We recently amended our existing $30 million credit facility, which lowered our interest rate by approximately 200 basis points at no cost to Eton and no change to the end of 2027 maturity date. We remain in a very strong financial position and expect to see our cash balance grow significantly throughout the year, even with planned debt principal repayments. We expect to have significant excess cash at our disposal that can be used for accretive product acquisitions.

我們近期修訂了既有的 3,000 萬美元信用額度，將利率下調約 200 個基點，且 Eton 無需承擔任何成本，並且到期日仍維持在 2027 年底不變。我們仍處於非常強健的財務狀況，並預期即使包含計畫中的債務本金償還，我們的現金餘額仍將在全年顯著增加。我們預期將有可觀的超額現金可用於具增益性的產品併購。

In addition, given our significant EBITDA generation and our diversified portfolio, we believe we'd have significant debt capacity available to us should a larger acquisition opportunity present itself. Before we conclude, I'd like to express my sincere gratitude to Sean, the entire team here at Eton for the opportunity to work alongside such a talented, dedicated, and passionate group of professionals.

此外，鑑於我們可觀的 EBITDA 產出以及多元化的產品組合，我們相信若出現較大型的併購機會，我們將具備可觀的舉債能力。在結束之前，我想向 Sean 以及 Eton 的全體團隊致上誠摯的感謝，感謝你們給我機會與這群才華洋溢、敬業且充滿熱情的專業人士並肩合作。

It's been a privilege to make a small contribution to Eton's remarkable growth and success, and most importantly, to the company's mission of improving the lives of the rare disease patients we serve. I'm extremely appreciative of the relationships and accomplishments that we've shared, and I remain confident that Eton will experience continued success and make a lasting impact on the healthcare community for many years to come. This concludes our remarks on first-quarter results.

能為 Eton 卓越的成長與成功略盡棉薄之力是我的榮幸，更重要的是，能協助公司實現改善我們所服務之罕見疾病患者生活的使命。我非常珍惜我們共同建立的關係與達成的成就，也仍然有信心 Eton 將在未來多年持續成功，並對醫療照護社群產生長遠影響。以上為我們對第一季業績的說明。

And with that, we'll turn it back over to the operator for Q&A.

接下來，我們把時間交還給主持人進行問答。

(Operator Instructions)

（主持人指示）

Madison El-Saadi, B. Riley Securities.

Madison El-Saadi，B. Riley Securities。

Congrats on the quarter. And James, congrats on all the success here at Eton and wishing you the best of luck. So when we look at the product-level dollar contribution behind your $10 million guide, maybe just walk us through that. And we should probably assume this is 4Q loaded. And then secondly, regarding the HEMANGEOL price, maybe walk us through the $8,000 per patient per year.

恭喜本季表現。James，也恭喜你在 Eton 取得的各項成果，並祝你一切順利。首先，當我們看你們 1,000 萬美元指引背後、以產品層級拆分的美元貢獻時，能否帶我們走一遍？我們大概應該假設這會偏向第四季貢獻較多。其次，關於 HEMANGEOL 的價格，能否說明一下每位病患每年 8,000 美元的計算？

How does this compare to the base price that Pierre had it set at? I'm guessing this captures a typical six-month course. And then if you could, any clarity into the proportion of the 8,000 patients that are retaining coverage at this new list price? And maybe since it's still pretty early, if you could just talk about kind of your expectations for that going forward?

這與 Pierre 先前設定的基準價格相比如何？我猜這涵蓋了一個典型的六個月療程。另外，如果可以的話，能否說明在 8,000 名病患中，有多少比例在新的牌價下仍能維持給付？以及由於目前仍算很早期，能否談談你們對未來走勢的大致預期？

Sure, Madison. Starting with your question on the guidance -- increase in guidance. The HEMANGEOL launch was a big part of that as we got more comfortable launching it and a little more insights of what we thought we could do this year as well as outperformance from the rest of our portfolio. We had a strong Q1. We were happy with the results.

當然，Madison。先談你關於指引上調的問題。HEMANGEOL 的上市是其中很大一部分原因，因為我們對推出它更有把握，也對今年能做到的事情有了更多洞見，同時我們產品組合的其他部分也表現優於預期。我們第一季表現強勁，對結果感到滿意。

We're seeing good trends already in Q2. We're happy with the DESMODA launch. So a combination of everything, but HEMANGEOL was definitely one of the important drivers of that. In terms of your question on the net price, yes, we do expect to net more than it was previously netting. We walked through -- roughly 60% to 65% of the patients will likely be non-revenue-generating or very low revenue-generating, but it should average out to around that $8,000 to $10,000 net price per patient.

我們在第二季已經看到不錯的趨勢。我們也對 DESMODA 的上市感到滿意。因此是多項因素的綜合，但 HEMANGEOL 絕對是其中一個重要的驅動因素。至於你問到的淨價，是的，我們確實預期淨價會高於先前的水準。我們也說明過——大約 60% 到 65% 的病患可能不會產生營收或僅產生非常低的營收，但平均下來，每位病患的淨價應可落在約 8,000 到 10,000 美元。

And that's our current estimate. Obviously, as you alluded to, it's still very early. We're only two weeks into it. I think it's too early to make any definitive statements to answer your question about the coverage. We historically had very good coverage on our products. So we expect that to continue, but too early in the launch to make any statements about that.

這是我們目前的估計。當然，如你所提到的，現在仍非常早期——我們才進行兩週。我認為現在要對你關於給付覆蓋的問題做出任何定論都還太早。我們過去在產品上一直有非常好的給付覆蓋，因此我們預期會延續，但在上市初期仍太早做任何說法。

Charles Wallace, H.C. Wainwright.

Charles Wallace，H.C. Wainwright。

This is Charles on for RK from H.C. Wainwright. So for my first question, something kind of struck me on the call, you said that HEMANGEOL could be the largest product by 2027. And I was just kind of curious, currently, on an annual run rate, what is currently the largest product currently sitting at for my first question?

我是 Charles，代表 H.C. Wainwright 的 RK 提問。我第一個問題是，電話會議中有件事引起我的注意：你提到 HEMANGEOL 到 2027 年可能會成為最大產品。我想請教，目前以年度化的營運跑速來看，現階段最大的產品大約落在什麼水準？

This is Sean. We have indicated INCRELEX is our current largest product that continues to grow as well. With HEMANGEOL, we have obviously big expectations for it. We've transferred a large number of the patients over to -- and we're continuing that transfer process. We'll provide a little bit more color, I would imagine, on future calls.

我是 Sean。我們已指出 INCRELEX 目前是我們最大的產品，而且也持續成長。至於 HEMANGEOL，我們對它當然有很高的期待。我們已將大量病患轉移過來——而且仍在持續進行轉移流程。我想我們會在未來的電話會議提供更多細節。

But we do want to see how this ramps before we can maybe give some directional guidance on that. Historically, we have not broken out sales by product, but we've spoken descriptively of it. And I think we'll certainly do that and revise our guidance as it transpires.

但在我們能夠提供一些方向性的指引之前，我們確實希望先觀察它的爬坡情況。過去我們並未按產品拆分揭露銷售額，但我們有以描述方式談到。我認為我們肯定會持續這麼做，並在情況發展時修訂我們的指引。

And I guess for my second question from me, so I guess where are you currently with the patient number for INCRELEX and are you confident with the 120 patients at the end of the year?

那我第二個問題是，INCRELEX 目前的病患數大概在哪裡？你們對年底達到 120 位病患有信心嗎？

Yes. So again, we're not going to get into patient counts. Otherwise, I'll be giving patient count updates on every call. I can tell you that we're very much on track with what we've stated previously. We're very pleased with INCRELEX's performance.

是的。所以再次說明，我們不會深入談病患人數，否則我每次電話會議都得更新病患數。我可以告訴你，我們非常符合先前所說的進度。我們對 INCRELEX 的表現非常滿意。

We have patients. It's been a great product. And it's the reason why it's our largest. We are also looking at initiating that label expansion study. So we do have significant plans for the product, and we'll keep everyone apprised as that enrolment occurs and as we get closer to being able to file that label update.

我們有病患，這一直是個很棒的產品，也正因如此它是我們最大的產品。我們也在評估啟動該適應症擴大（標籤擴增）研究。因此我們對這個產品有相當多的計畫，並會在招募進行以及更接近能提交標籤更新申請時，持續向大家通報。

And sorry, one more question, if I may. So I was just curious if -- as you're acquiring all these products, is it one specialty pharmacy that's handling all these drugs in the distribution?

不好意思，如果可以的話我再問一個問題。想請教，當你們收購這些產品時，在通路配送上是否由同一家專科藥局負責處理所有這些藥品？

That is correct. As we -- that's a good question, actually, because we've been -- we certainly -- that's where we're at today. And as long as they can continue to service our needs and meet our objectives for our portfolio, we're very happy with them. But we are -- we do have aspirations to have the largest, rare disease portfolio in the industry. And if ever comes a point where we think we need to add another specialty pharmacy, we'll do that. But for right now, we're very pleased with Anovo and the work that they do.

沒錯。就我們——這其實是個好問題，因為我們一直——我們當然——這就是我們目前的狀況。只要他們能持續滿足我們的需求並達成我們投資組合的目標，我們就對他們非常滿意。不過我們——我們確實有志向要打造業界最大的罕見疾病產品組合。若未來某個時點我們認為需要再增加一家專科藥局，我們就會這麼做。但就目前而言，我們對 Anovo 以及他們所做的工作非常滿意。

Chase Knickerbocker, Craig-Hallum.

Chase Knickerbocker，Craig-Hallum。

Congrats on another nice quarter here. Sean, could you maybe just bridge the kind of change in guidance? Was -- the updated raised guidance, was it solely driven by kind of refining the HEMANGEOL model? Or what else drove it as far as how your assumptions changed from March to now?

恭喜又交出一個不錯的季度。Sean，你能否說明一下指引變動的銜接？也就是更新後上調的指引，是否完全是因為你們對 HEMANGEOL 模型做了更精細的調整所驅動？還是還有其他因素，包含你們的假設從 3 月到現在有哪些改變？

Sure. So as David had indicated earlier, we have driven -- we've raised that guidance for a number of factors. Certainly, HEMANGEOL was a key part of that. Two, our base business, the commercial sales levels continue to be very strong. And as we're going into -- in the past few weeks, we see that momentum continue.

當然。如同 David 先前提到的，我們上調指引是由多項因素所推動。HEMANGEOL 當然是其中的關鍵之一。第二，我們的基本業務，也就是商業銷售水準，持續非常強勁。而且在過去幾週，我們看到這股動能仍在延續。

Really across the board, we've been kind of hitting our numbers that we expect. And I guess the third thing is DESMODA, that launch is bringing in a significant number of patients. We're very happy with the launch. We just got out of an endocrinology meeting where there's a tremendous amount of excitement on that product, and I'm hoping to provide a little bit more clarity on what we think that -- ultimately that product can do. We've given off that guidance of $30 million to $50 million.

基本上各方面，我們都大致達成我們預期的數字。我想第三點是 DESMODA，該產品上市帶來了相當可觀的病患數。我們對這次上市非常滿意。我們剛從一場內分泌學會議出來，大家對這個產品有非常高的興奮度；我也希望能更清楚說明我們認為——最終這個產品能做到什麼。我們已給出的指引是 3,000 萬到 5,000 萬美元。

We'll update that, I imagine, on our -- on future calls. And we'll see how -- but all of that kind of came together. And we said more than $120 million. So obviously, it's more than $120 million. We don't -- we'll leave it at that, and we'll see what happens.

我想我們會在——未來的電話會議上更新。我們也會看看——但所有這些因素加總起來，我們說會超過 1.2 億美元。所以很明顯，是超過 1.2 億美元。我們——就先說到這裡，接下來就看結果如何。

Helpful. And maybe if I can draw some cross-currents between kind of your experiences with GALZIN and HEMANGEOL here. I mean you guys did a pretty good job of switching those patients pretty quickly into your distribution platform.

很有幫助。也許我可以把你們在 GALZIN 和 HEMANGEOL 的經驗做一些對照。我是說，你們在把那些病患相當快速地轉到你們的配送平台上，做得很不錯。

I mean maybe talk about some of the learnings that you had from GALZIN and potential -- the potential for any sort of opportunity to do a little bit better than you guys are expecting as far as the kind of switching of those patients into your platform? Because again, we did outperform on GALZIN. So maybe just kind of talk about if that's a fair comparison and just some of your learnings.

能否談談你們從 GALZIN 學到的一些經驗，以及——在把這些病患轉入你們平台的過程中，是否有任何機會讓表現比你們目前預期更好？因為我們在 GALZIN 的確是超出預期。所以也請談談這樣的比較是否合理，以及你們的一些學習。

Sure. So Chase, I'm going to turn that question over to our Chief Commercial Officer, Ipek. Ipek?

當然。Chase，我把這個問題交給我們的首席商務長 Ipek。Ipek？

Thank you for the question. That is actually a great parallel, Few things that are very similar and a few things that are different. I think with GALZIN, it was all open network. It was multiple pharmacies. We actually -- we didn't even have the luxury at the time of collaborating with those pharmacies.

謝謝你的提問。這確實是一個很好的對照。有幾點非常相似，也有幾點不同。我認為在 GALZIN 的情況下，是完全開放式網路，有多家藥局。我們其實——當時甚至沒有機會與那些藥局合作。

So we kind of had to find all those patients ourselves. And I think we did a very good job, very effective job. And we knew at the time, without any numbers, anything that we inherited from the previous ownership that there was around 200 to 300 patients that were already on GALZIN. I think we already shared before, we are already over those numbers. We are about 300 patients already within the course of the year, which obviously was a very effective transition without having any collaboration.

所以我們某種程度上必須自己找出所有那些病患。我認為我們做得非常好、非常有效率。而且當時在沒有任何數據、也沒有從前一任持有人那邊繼承任何資訊的情況下，我們知道大約有 200 到 300 位病患已在使用 GALZIN。我想我們之前也分享過，我們現在已經超過那些數字了。我們在一年內就已經大約有 300 位病患，這顯然是在沒有任何合作的情況下完成的一次非常有效的轉換。

I think with HEMANGEOL the positives there obviously are -- there were 17 pharmacies, but this is also 8,000 patients. It's a big -- much bigger existing base of active patients. And basically pulling them from some local small pharmacies, some big pharmacies like Walgreens, so we've been working very hard for about 60 days between our sales team putting transition agreements with some of those pharmacies as well as Anovo, our specialty pharmacy, pulling those transfers through, which has been very good. Almost 60% of that 8,000 base, we were able to actually put some sort of a collaboration with the former pharmacies to agree to transfer the patients. So that's because we have been very good.

我認為在 HEMANGEOL 方面，正面的地方很明顯是——雖然有 17 家藥局，但這同時是 8,000 位病患。這是一個更大——大得多的既有活躍病患基礎。基本上要把他們從一些地方性小藥局、以及像 Walgreens 這樣的大型藥局轉出來，所以在過去大約 60 天，我們非常努力：一方面由我們的銷售團隊與其中一些藥局簽訂轉換協議，另一方面由我們的專科藥局 Anovo 來推動這些轉檔，效果非常好。在這 8,000 的基礎中，將近 60% 我們實際上能與原先的藥局建立某種合作，讓他們同意轉移病患。這是因為我們做得非常好。

But at the same time, it's a much bigger volume of patients to serve and make sure that there's continuity of care, nobody is behind without their drug. It's a much shorter course of therapy. That's another important distinction with GALZIN Obviously, it's a lifetime chronic therapy. So we still are finding those patients who were on GALZIN but also converting from patients who have never been on GALZIN on the competitive over-the-counter non-Rx therapies. So that's the goal right now of that conversion.

但同時，這是更大量的病患需要服務，並確保照護不中斷、沒有人因為拿不到藥而被落下。療程也短得多。這是與 GALZIN 的另一個重要差異。GALZIN 顯然是終身的慢性治療。因此我們仍在找出那些曾使用 GALZIN 的病患，同時也在把從未使用 GALZIN、而是使用競品的非處方（OTC）非處方籤（non-Rx）療法的病患轉換過來。這就是目前轉換的目標。

But with HEMANGEOL, it's the -- time is of essence because we need to get those 8,000 patients into our system, serve them without any disruption, but also it's a six-month therapy window. So we need to start acquiring new patients as well.

但對 HEMANGEOL 而言，時間——至關重要，因為我們需要把那 8,000 位病患導入我們的系統，在不中斷的情況下服務他們；同時它是 6 個月的治療窗口。因此我們也需要開始取得新病患。

Helpful color. And then maybe just last from me, James, one last question for you here. Just as we think about the magnitude of the amount of OUS revenue for INCRELEX in the quarter if you could share that. And then just what the associated COGS was of that? And certainly wish you all the best in your next endeavours, and it's been a pleasure working with you.

很有幫助的補充。最後我這邊再問一個，James，最後一題想請教你。就本季 INCRELEX 的海外（OUS）營收規模，如果你方便的話能否分享一下？以及相關的銷貨成本（COGS）是多少？也祝你未來一切順利，與你合作很愉快。

Likewise. Thanks, Chase. So we have -- as far as the diluted margin profile on our ex USNCRELEX revenue, it's about 2:1. So $2 of COGS to $1 of revenue. And it was low single-digit millions in Q1. We should have maybe a handful of similar orders. I think previously, we have estimated annual ex USNCRELEX revenue of $2 million to $3 million, and that's still the estimate for 2026.

我也是。謝謝你，Chase。就我們美國以外 NC REXLEX（ex USNCRELEX）營收的稀釋後毛利結構而言，大約是 2:1。也就是每 1 美元營收對應 2 美元的 COGS。第一季大約是低個位數百萬美元。我們之後可能還會有少數幾筆類似的訂單。我想先前我們估計年度美國以外 NC REXLEX 營收為 200 萬到 300 萬美元，而這仍是 2026 年的估計。

Thank you. This concludes the question-and-answer session. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

謝謝。本次問答環節到此結束。感謝各位參與今天的電話會議。本次會議至此結束。您現在可以掛線。