Eton Pharmaceuticals Inc (ETON) 2025 Q2 法說會逐字稿

Thank you for standing by. My name is Alex, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Eton Pharmaceuticals Q2 2025 earnings call. (Operator Instructions)

感謝您的支持。我叫亞歷克斯，今天我將擔任您的會議主持人。現在，我歡迎大家參加 Eton Pharmaceuticals 2025 年第二季財報電話會議。（操作員指示）

Thank you. I would now like to turn the call over to Mr. David Krempa. Please go ahead.

謝謝。現在我想把電話轉給大衛克倫帕先生。請繼續。

Thank you, operator. Good afternoon, everyone, and welcome to Eton's second 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.

謝謝您，接線生。大家下午好，歡迎參加伊頓 2025 年第二季電話會議。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話題。新聞稿可在我們的網站 etonpharma.com 上查閱。

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 the call today, we will be answering questions that are e-mailed to us. Investors can send their questions to investorrelations@etonpharma.com.

今天參加電話會議的還有我們的執行長 Sean Brynjelsen、我們的財務長 James Gruber 和我們的商務長 Ipek Trinkaus。除了今天在電話會議上現場回答問題外，我們還將回答透過電子郵件發送給我們的問題。投資者可以將問題發送至 investorrelations@etonpharma.com。

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

在我們開始之前，我想提醒大家，今天電話會議上的言論可能包含前瞻性陳述，並涉及風險和不確定性，可能導致實際結果與這些前瞻性陳述中的結果有重大差異。請參閱我們收益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，我將把電話轉給我們的執行長 Sean Brynjelsen。

Thank you, David. Good afternoon, everyone, and thank you for joining us today. I'm excited to be discussing our results, and it was another record quarter for the company. It is truly the most exciting time in our history. We entered 2025 with strong momentum from the growth of our existing portfolio, plus the closing of some value-creating acquisitions in December.

謝謝你，大衛。大家下午好，感謝大家今天的參與。我很高興能夠討論我們的業績，這對公司來說又是一個創紀錄的季度。這確實是我們歷史上最令人興奮的時刻。我們邁入 2025 年，得益於現有投資組合的成長以及 12 月完成的一些創造價值的收購，我們擁有強勁的發展勢頭。

The momentum carried into the second quarter in the business continues to fire on all cylinders. From our stellar commercial execution to the advancement of our pipeline programs from our development and regulatory functions, I could not be happier with the performance from the team this year.

進入第二季度，業務動能持續全速發展。從我們出色的商業執行到我們開發和監管職能中管道計劃的進步，我對團隊今年的表現感到非常滿意。

While we knew that 2025 was going to be a transformational time for Eton with three product launches planned, I am pleased to say it is going even better than we expected. The second quarter was particularly productive with a number of critical achievements, including the ongoing relaunches of INCRELEX and GALZIN, which resulted in record product sales and more than 100% revenue growth year-over-year.

雖然我們知道 2025 年將是 Eton 的轉型時期，並計劃推出三款產品，但我很高興地說，它的進展比我們預期的還要好。第二季尤其富有成效，取得了許多重要成就，包括正在重新推出的 INCRELEX 和 GALZIN，這帶來了創紀錄的產品銷售額和同比增長超過 100% 的收入。

FDA approval of KHINDIVI and the launch within days of the approval, marking our eighth ultra-rare disease product (technical difficulty) The NDA submission for ET-600, another high-value pediatric endocrinology product candidate, which was subsequently accepted for review and assigned a February 2026 PDUFA date.

FDA 批准 KHINDIVI 並在批准後幾天內上市，標誌著我們的第八種極罕見疾病產品（技術難度） ET-600 的 NDA 提交，這是另一種高價值兒科內分泌候選產品，隨後被接受審查並指定了 2026 年 2 月的 PDUFA 日期。

This gives us another near-term product launch in the first quarter of 2026. And we delivered on the bottom line, generating $8 million of cash flow from operations, and $3.1 million of adjusted EBITDA, highlighting our commitment to profitability and providing us with additional capital for future acquisitions.

這使得我們將在 2026 年第一季推出另一款近期產品。我們實現了盈利，產生了 800 萬美元的營運現金流和 310 萬美元的調整後 EBITDA，突顯了我們對盈利的承諾，並為我們未來的收購提供了額外的資本。

Turning to the results. Revenue was $18.9 million in the quarter, a remarkable 108% over the prior year period. We've now grown product revenue for 18 straight quarters every quarter since the launch of ALKINDI SPRINKLE in 2020.

談到結果。本季營收為 1,890 萬美元，較去年同期成長 108%。自 2020 年推出 ALKINDI SPRINKLE 以來，我們已連續 18 個季度實現產品收入成長。

The increase was driven from broad performance across our portfolio, but the biggest contributors were continued growth in ALKINDI SPRINKLE, and the addition of revenue from INCRELEX and GALZIN. When we hosted our Investor Day in March, we provided guidance that we expected to exit 2025 at an $80 million revenue run rate. Based on the outperformance in the first half of this year, we now expect to reach the $80 million run rate in the third quarter, a full three months ahead of schedule.

這一增長得益於我們整個投資組合的廣泛表現，但最大的貢獻者是 ALKINDI SPRINKLE 的持續成長，以及 INCRELEX 和 GALZIN 的收入增加。當我們在三月舉辦投資者日時，我們提供了指導，預計 2025 年的收入運行率將達到 8000 萬美元。基於今年上半年的優異表現，我們現在預計第三季的營業額將達到 8,000 萬美元，比計劃提前整整三個月。

Turning to product-specific commentary. I will start with INCRELEX. INCRELEX has continued to exceed expectations, and we could not be happier with this acquisition. As a reminder, when we acquired the product in late December 2024, it had only 67 active patients.

轉向針對具體產品的評論。我將從 INCRELEX 開始。INCRELEX 的表現持續超出預期，我們對此收購感到非常高興。提醒一下，當我們在 2024 年 12 月下旬收購該產品時，它只有 67 名活躍患者。

Our goal was to reach 100 active patients by the end of 2025. I'm pleased to share that we reached that goal a couple of weeks ago, five months ahead of schedule. This achievement did not come easy. The product had been flat or declining for many years prior to our acquisition, and it has taken a lot of hard work from our entire organization to reverse the trend.

我們的目標是到 2025 年底達到 100 名活躍患者。我很高興地告訴大家，我們幾週前就達成了這個目標，比計畫提早了五個月。這項成就來得並不容易。在我們收購之前，該產品多年來一直處於平穩或下滑狀態，我們整個組織付出了很多努力才扭轉這一趨勢。

Since our January relaunch, we have made significant investments to improve education and awareness among the community. Our team had a major presence at the key endocrinology conferences this year, including Pediatric Endocrinology Nursing Society, the Pediatric Endocrinology Society and most recently, the Endocrinology Society Annual Meeting.

自一月重新啟動以來，我們已投入大量資金來提高社區的教育和意識。我們的團隊在今年的主要內分泌學會議上發揮了重要作用，包括兒科內分泌護理學會、兒科內分泌學會以及最近的內分泌學會年會。

During these conferences, we held multiple advisory boards, participated in product symposia, hosted exhibit booths, presented a new scientific poster featuring real-world registry and held hundreds of meetings with leading pediatric endocrinologists. We believe Eton is uniquely positioned to be able to drive such immediate INCRELEX adoption because of our deep relationships with the pediatric endocrinology community.

在這些會議期間，我們舉辦了多個諮詢委員會，參加了產品研討會，設立了展位，展示了以真實世界登記為特色的全新科學海報，並與領先的兒科內分泌學家舉行了數百次會議。我們相信，由於我們與兒科內分泌學界有著深厚的關係，伊頓公學具有獨特的優勢，能夠推動 INCRELEX 的快速普及。

These strong relationships should also benefit our launches of KHINDIVI and soon ET-600. I'm very happy with the initial INCRELEX results, but our work is not done. We believe severe primary IGF-1 deficiency is still significantly undiagnosed, and we have more to do on the awareness and education front.

這些牢固的關係也有利於我們推出 KHINDIVI 和即將推出的 ET-600。我對 INCRELEX 的初步結果非常滿意，但我們的工作還沒有完成。我們認為，嚴重的原發性 IGF-1 缺乏症仍未被充分診斷​​，我們在意識和教育方面還有很多工作要做。

While the rate of future additions is not likely to match what we saw in the first six months of ownership, we remain confident that a large opportunity remains. Our new goal is to reach 110 patients by the end of this year. And over the next few years, we hope to be able to return to the level of 185 patients that were once on treatment.

儘管未來的增加速度可能不會與我們在我們擁有的前六個月所看到的相匹配，但我們仍然相信仍然存在巨大的機會。我們的新目標是在今年年底覆蓋 110 名患者。在接下來的幾年裡，我們希望能夠恢復到曾經接受治療的 185 名患者的水平。

Reaching that 185 long-term goal would result in roughly $50 million to $60 million of annual sales for the company. In addition, we see an even greater opportunity for long-term growth through the harmonization of the US and EU definitions of severe primary IGF-1 deficiency. As discussed previously, the EU currently has a broader definition.

實現 185 個長期目標將為公司帶來約 5,000 萬至 6,000 萬美元的年銷售額。此外，我們看到，透過協調美國和歐盟對嚴重原發性 IGF-1 缺乏症的定義，將帶來更大的長期成長機會。如前所述，歐盟目前有一個更廣泛的定義。

In the US, patient's IGF level must be at least 3 standard deviations below the median. While in Europe, the level needs to be only approximately 2 standard deviations below. INCRELEX's previous owner has been running a patient registry in Europe, which has collected data from hundreds of patients over the past (technical difficulty) years.

在美國，患者的 IGF 水準必須比中位數低至少 3 個標準差。而在歐洲，該水準僅需低於約 2 個標準差。INCRELEX 的前任所有者一直在歐洲運營一家患者登記處，該登記處在過去（技術難度）幾年中收集了數百名患者的數據。

To us, this real-world data clearly demonstrates that the product is safe and effective for patients whose IGF levels are between -2 and -3 standard deviations. We recently approached the FDA to discuss harmonizing the definition between the two regions.

對我們來說，這些真實世界的數據清楚地表明，該產品對於 IGF 水平在 -2 到 -3 個標準差之間的患者是安全有效的。我們最近與 FDA 接洽，討論協調兩個地區的定義。

The agency communicated to us that some type of follow-on clinical study would likely be necessary. As such, they requested that we put together a protocol design and request a meeting. We are in the process of working with external consultants to draft the design that is achievable and meets the FDA requirements.

該機構告訴我們，可能需要進行某種類型的後續臨床研究。因此，他們要求我們制定協議設計並要求召開會議。我們正在與外部顧問合作起草可實現且符合 FDA 要求的設計。

We intend to submit a treatment IND for an open-label study where we would enroll patients with IGF levels between -2 and -3 standard deviations. While it's too early for us to speculate on the precise time or cost of such a study, we believe the large commercial opportunity would more than justify any reasonable amount of time and capital invested into such a study.

我們打算提交一項開放標籤研究的治療 IND，其中我們將招募 IGF 水平在 -2 至 -3 個標準差之間的患者。雖然現在推測此類研究的具體時間或成本還為時過早，但我們相信，巨大的商業機會足以證明在此類研究中投入的任何合理的時間和資金都是值得的。

As a reminder, we currently estimate that there are approximately 200 patients in the US that meet the -3 standard deviation criteria, but believe more than 1,000 would meet the broader -2 standard deviation criteria. If successful, that would grow potential market from around $60 million a year to nearly $300 million per year. We will keep you updated as our discussions with the FDA progress.

提醒一下，我們目前估計美國大約有 200 名患者符合 -3 標準差標準，但相信超過 1,000 名患者符合更廣泛的 -2 標準差標準。如果成功的話，潛在市場規模將從每年約 6,000 萬美元增長至每年近 3 億美元。我們將隨時向您通報我們與 FDA 討論的進展。

Turning now to our adrenal insufficiency franchise of ALKINDI SPRINKLE and KHINDIVI. We were excited to receive FDA approval of KHINDIVI on May 28th. As the only FDA-approved oral solution of hydrocortisone, KHINDIVI fulfills a critical unmet need by allowing simple and accurate dosing tailored to each patient's needs.

現在來談談我們的腎上腺功能不全特許經營權 ALKINDI SPRINKLE 和 KHINDIVI。我們很高興 5 月 28 日收到 FDA 對 KHINDIVI 的批准。作為唯一獲得 FDA 批准的氫化可的鬆口服溶液，KHINDIVI 可根據每位患者的需求進行簡單、準確的劑量調整，滿足了一項關鍵的未滿足需求。

It does not require refrigeration, mixing or shaking and eliminates the need to split or crush tablets, which can lead to inaccurate dosing. KHINDIVI was approved for pediatric patients five years of age and older. While we and our toxicologists believe the data shows that the product is safe for infants as young as one month, the FDA had reservations due to a limited amount of safety data around how three of our inactive ingredients are metabolized when used in combination.

它不需要冷藏、混合或搖晃，也無需分割或壓碎藥片，從而避免劑量不準確。KHINDIVI 被批准用於治療五歲及以上的兒科患者。雖然我們和我們的毒理學家認為數據表明該產品對一個月大的嬰兒來說是安全的，但由於有關我們的三種非活性成分在組合使用時如何代謝的安全數據有限，FDA 對此持保留態度。

Because of this, the FDA ultimately approved the product with a label of patients aged five and above. Roughly 60% of our ALKINDI patients are four and under, so we expect this age limit will be a near-term hindrance to the KHINDIVI launch trajectory.

正因如此，FDA最終批准了該產品，並標註其適用於5歲及以上患者。我們 ALKINDI 患者中約有 60% 年齡在四歲以下，因此我們預計這一年齡限制將在短期內阻礙 KHINDIVI 的推出。

However, we have a plan in place that should make it a short-lived headwind. We know there is a huge unmet need for this product among infants and toddlers, and we remain committed to addressing it. Once feedback was received on our label, we immediately went to work on a revised formulation that drastically reduces the amount of these three excipients.

然而，我們已經制定了計劃，應該可以讓它成為短暫的逆風。我們知道嬰幼兒對該產品有巨大的未滿足需求，我們將繼續致力於解決這個問題。在收到有關我們標籤的回饋後，我們立即著手修改配方，大幅減少這三種賦形劑的用量。

We've already manufactured registration batches of the revised formulation and have a pre-submission meeting with the FDA scheduled for September. Our current plan is to submit a prior approval supplement in the first half of 2026, which could allow for an approval and a broadened label by the end of 2026.

我們已經生產了修訂配方的註冊批次，並計劃於 9 月與 FDA 舉行提交前會議。我們目前的計劃是在 2026 年上半年提交一份事先批准補充文件，以便在 2026 年底之前獲得批准並擴大標籤範圍。

Despite this initial headwind, we've already seen adoption among patients and have received favorable feedback from families and caregivers. Many physicians have told us they plan to switch all their patients, five and up, that were previously on compounded products. These switches have been occurring as patients have their regularly scheduled checkups.

儘管最初存在困難，但我們已經看到患者採用該技術，並收到了來自家人和照護者的正面回饋。許多醫生告訴我們，他們計劃為所有先前服用複方藥物的五歲以上的患者進行更換。這些轉變是在患者進行定期檢查時發生的。

Now in its fifth year, ALKINDI SPRINKLE continues to deliver robust growth with no signs of slowing down. In fact, the first half of 2025 generated more new ALKINDI scripts than any other six month period in the product's history.

ALKINDI SPRINKLE 現已進入第五年，持續保持強勁成長，且沒有放緩的跡象。事實上，2025 年上半年產生的新 ALKINDI 腳本比該產品歷史上任何其他六個月期間都要多。

Adding KHINDIVI to the mix should allow us to accelerate that growth. Our combined adrenal insufficiency franchise recently eclipsed 500 active patients, and we remain confident that we can reach $50 million of combined sales in the coming years, which would be approximately 1,000 active patients. Ultimately, we expect to reach much higher levels than that once the KHINDIVI label is expanded.

將 KHINDIVI 添加到組合中應該可以讓我們加速這一增長。我們的腎上腺功能不全特許經營權最近超過了 500 名活躍患者，我們仍然有信心在未來幾年內達到 5000 萬美元的綜合銷售額，這將相當於大約 1000 名活躍患者。最終，我們希望 KHINDIVI 標籤擴展後能夠達到更高的水平。

Another important value driver for us for sure is GALZIN. With the acquisition of GALZIN, we saw another opportunity to add significant value and improve access for patients with Wilson disease. After the acquisition, our first priority was to solve GALZIN's historic access and affordability issues. Before Eton acquired GALZIN, very few pharmacies actually stocked the drug. Supplies were occasionally out of stock.

對我們來說，另一個重要的價值驅動因素肯定是 GALZIN。透過收購 GALZIN，我們看到了另一個增加重大價值並改善威爾遜氏症患者治療機會的機會。收購之後，我們的首要任務是解決 GALZIN 歷史遺留的可近性和可負擔性問題。在 Eton 收購 GALZIN 之前，實際上很少有藥局儲存這種藥物。物資有時會缺貨。

No patient support services were in place to help with insurance paperwork, and there was no financial support. So even if patients were able to get the product, many of them faced very expensive out-of-pocket costs.

沒有病患支援服務來幫助辦理保險文書工作，也沒有經濟支援。因此，即使患者能夠獲得該產品，許多患者仍需支付非常昂貴的自付費用。

As a result, we believe that the majority of patients in the US that were on zinc therapy were actually taking an inferior non-FDA-approved over-the-counter zinc gluconate supplement. For years, doctors have been hesitant to prescribe GALZIN because of these access issues.

因此，我們認為，美國大多數接受鋅療法的患者實際上服用的是未經 FDA 批准的劣質非處方葡萄糖酸鋅補充劑。多年來，由於這些取得問題，醫生一直不願開出 GALZIN 處方。

They knew there was a good chance they would get a call back from a patient saying the co-pay was too expensive or their pharmacy did not stock it or they needed support with insurance paperwork. As a result, many doctors had turned to recommending supplement products strictly because access was easier.

他們知道很有可能會接到患者的回電，說共同支付的費用太高，或者藥房沒有庫存，或者他們需要保險文書的支持。因此，許多醫生轉而推薦補充產品，因為這樣比較容易取得。

We knew we could solve these issues with our best-in-class patient support program, dedicated rare disease specialists and extensive education and awareness campaign. GALZIN is now available exclusively through the Eton Cares patient support program, which offers $0 co-pay for qualified patients, 24, 7 customer support, allowing every patient who wants GALZIN to get it regardless of financial circumstances. Now the message is clear to physicians.

我們知道，我們可以透過一流的患者支援計劃、專門的罕見疾病專家以及廣泛的教育和宣傳活動來解決這些問題。GALZIN 現已透過 Eton Cares 患者支援計劃獨家獲得，該計劃為符合條件的患者提供 0 美元共同支付費用和 24、7 天客戶支援，讓每位想要獲得 GALZIN 的患者無論經濟狀況如何都能獲得治療。現在醫生們已經清楚地了解了這個訊息。

If they prescribe GALZIN for their Wilson patients, Eton Cares will make sure the patient receives the product. They are now prescribing GALZIN with this peace of mind. In addition, under diagnosis has also been a major problem with Wilson disease.

如果他們為 Wilson 患者開出 GALZIN 處方，Eton Cares 將確保患者收到該產品。現在，他們安心地開出了 GALZIN 處方。此外，對威爾遜氏症的診斷不足也是一大問題。

The majority of patients aren't diagnosed until adulthood when symptoms begin to present themselves after decades of copper buildup. The delay in diagnosis leads to worse outcomes, including neurological damage and liver failure.

大多數患者直到成年後才被診斷出來，那時經過數十年的銅積累，症狀才開始顯現。診斷的延遲會導致更糟糕的後果，包括神經損傷和肝衰竭。

Wilson disease is believed to impact approximately 10,000 people in the United States, but only about 20% are diagnosed and on therapy. We expect to see a long-term tailwind as increased genetic testing and better screening leads to higher rates of diagnosis and more patients starting preventive zinc therapy.

據信，威爾遜氏症影響了美國約 10,000 人，但只有約 20% 的人得到診斷並接受治療。我們預計會看到長期的順風，因為增加基因檢測和更好的篩檢會帶來更高的診斷率，並且會有更多患者開始接受預防性鋅療法。

As I mentioned earlier, our GALZIN launch is off to a strong start, and we expect the trajectory to continue. I believe the majority of existing GALZIN users have now been converted to our product. We're aiming to reach 200 active patients by the end of this year, setting the foundation for continued growth in the years ahead.

正如我之前提到的，我們的 GALZIN 發布會開局良好，我們預計這一勢頭將會持續下去。我相信大多數現有的 GALZIN 用戶現在都已經轉向使用我們的產品。我們的目標是在今年年底前達到 200 名活躍患者，為未來幾年的持續成長奠定基礎。

In addition to removing barriers to access, we think we can do even more to improve the lives of Wilson disease patients. Currently, GALZIN must be taken 3 times per day, and patients must fast before and after taking the medication. This is a burdensome process for patients and leads to poor compliance.

除了消除獲得醫療服務的障礙之外，我們認為我們還可以做更多的事情來改善威爾遜病患者的生活。目前，GALZIN 必須每天服用 3 次，且患者在服藥前後必須禁食。這對患者來說是一個繁重的過程，並且會導致患者依從性較差。

To address these issues, we're developing ET-700, an extended-release version of GALZIN. Our team initiated the program prior to the acquisition of GALZIN and have now filed a patent on our proprietary formulation.

為了解決這些問題，我們正在開發 ET-700，這是 GALZIN 的擴展版本。我們的團隊在收購 GALZIN 之前就啟動了該計劃，並且現在已經為我們的專有配方申請了專利。

During the second quarter, we held a meeting with the FDA to discuss the clinical pathway for ET-700. We view the outcome of this meeting positively since clarity on the study program and clinical requirements was achieved.

第二季度，我們與 FDA 舉行會議，討論 ET-700 的臨床路徑。我們對這次會議的結果持積極態度，因為會議明確了研究計劃和臨床要求。

Based on the FDA feedback, our plan is to initiate a proof-of-concept study near the end of this year, followed by a dose-ranging and pivotal Phase 3 study. ET-700 represents another very large market opportunity for Eton.

根據 FDA 的回饋，我們的計劃是在今年年底啟動一項概念驗證研究，然後進行劑量範圍和關鍵的 3 期研究。ET-700 對 Eton 來說代表著另一個非常大的市場機會。

With this product, we believe we would capture a majority of the estimated 800 US patients on some form of zinc therapy and generate more than $100 million in annual revenue. During the quarter, we continued to make progress with our other pipeline product candidates, the most notable of which is ET-600.

我們相信，透過該產品，我們將吸引大多數接受某種形式鋅療法的美國患者，預計患者人數為 800 人，年收入將超過 1 億美元。在本季度，我們在其他候選產品方面繼續取得進展，其中最引人注目的是 ET-600。

Last month, the FDA announced that it accepted our ET-600 NDA and assigned our target action date of February 25, 2026. In the last few weeks, we were also awarded a second patent for the product, which grants us protection through 2044. As a reminder, ET-600 is our proprietary oral solution of desmopressin under development for the treatment of diabetes insipidus.

上個月，FDA 宣布接受我們的 ET-600 NDA，並將我們的目標行動日期指定為 2026 年 2 月 25 日。在過去的幾周里，我們還獲得了該產品的第二項專利，該專利將為我們提供長達 2044 年的保護。提醒一下，ET-600 是我們正在開發的用於治療尿崩症的去氨加壓素專有口服溶液。

Right now, desmopressin is approved in tablet, nasal and injectable forms, none of which allow for the small, precise and titratable doses needed for younger patients. Many pediatric patients use unapproved compounded liquid suspensions or are forced to cut tablets.

目前，去氨加壓素已獲批准的劑型有片劑、鼻腔用藥和注射劑，但這些劑型均無法滿足年輕患者所需的小劑量、精確劑量和可滴定劑量。許多兒科患者使用未經批准的複合液體懸浮液或被迫切藥片。

If approved, ET-600 would be the only oral liquid option on the market, addressing a significant unmet need we've identified within the pediatric endocrinology community. We hosted an ET-600 advisory board with key opinion leaders last month at the ENDO conference, and the feedback was overwhelmingly positive.

如果獲得批准，ET-600 將成為市場上唯一的口服液選擇，解決我們在兒科內分泌學界發現的重大未滿足需求。上個月，我們在 ENDO 會議上與主要意見領袖一起主持了一個 ET-600 諮詢委員會，反饋非常積極。

The healthcare community is anxious to see the product on the market and our commercial launch activities are underway in anticipation of a potential Q1 2026 launch. Given our strong presence in pediatric endocrinology with existing promotion of ALKINDI SPRINKLE, KHINDIVI and INCRELEX, we expect to be able to hit the ground running with a strong launch in 2026.

醫療保健界迫切希望看到該產品上市，我們正在進行商業發布活動，預計將於 2026 年第一季推出。鑑於我們在兒科內分泌領域的強大影響力以及對 ALKINDI SPRINKLE、KHINDIVI 和 INCRELEX 的現有推廣，我們預計能夠在 2026 年強勢推出，從而迅速取得進展。

The potential ET-600 launch should bolster our already strong near-term growth prospects, and we will continue to further turbocharge our growth with additional product acquisitions. Opportunistic business development transactions have been central to our historic growth, and we remain on the hunt for new product acquisitions.

ET-600 的潛在推出應該會增強我們本已強勁的近期成長前景，並且我們將繼續透過額外的產品收購來進一步推動我們的成長。機會性業務發展交易一直是我們歷史性成長的核心，我們仍在尋找新的產品收購。

We are doing so from an attractive position of strength, both financially and operationally. Eton has more than $30 million of cash on hand and great access to additional capital, if necessary, to fund any acquisitions or transactions that fit our strategy.

我們在財務和營運方面都具有優勢，因此我們這樣做是因為我們擁有強大的實力。伊頓擁有超過 3000 萬美元的現金，並且如有必要，可以獲得大量額外資本，以資助任何符合我們策略的收購或交易。

Given the robust growth outlook of our existing product and pipeline, we are under no pressure to chase acquisitions, however. We will remain disciplined as we pursue approved or late-stage ultra-rare disease products that are strategically and financially attractive.

然而，鑑於我們現有產品和通路的強勁成長前景，我們並沒有面臨收購的壓力。我們將保持紀律，追求具有策略和財務吸引力的已批准或後期極罕見疾病產品。

While I am proud of the record second quarter sales and the massive revenue growth, I am even prouder of our ability to do so profitably. As you know, we pride ourselves on running a fiscally responsible business and are not interested in growing revenue if it does not lead to profitability. This quarter, we have started to show early signs of the immense earnings power of our business.

我為第二季創紀錄的銷售額和龐大的收入成長感到自豪，但更為我們能夠獲利而感到自豪。如您所知，我們為經營一家財務負責的企業而感到自豪，如果不能帶來盈利，我們就不會對增加收入感興趣。本季度，我們已經開始展現出我們業務巨大盈利能力的早期跡象。

We generated $8 million of operating cash flow and delivered strong adjusted EBITDA and non-GAAP earnings per share. We've now made the necessary SG&A investments to support our broader portfolio and larger revenue base. So we expect to continue to see meaningful margin expansion, as expenses remain relatively flat, while revenue grows in the coming quarters.

我們產生了 800 萬美元的營運現金流，並實現了強勁的調整後 EBITDA 和非 GAAP 每股收益。我們現在已經進行了必要的銷售、一般及行政費用投資，以支持我們更廣泛的投資組合和更大的收入基礎。因此，我們預計利潤率將繼續大幅擴張，因為支出保持相對平穩，而收入在未來幾季將成長。

Great companies are not built overnight, and it has taken many years of dedication from our team to put us in a position we are in today. I am thankful for all of their hard work and incredibly impressed by the team's ability to execute and outperform across all facets of the business.

偉大的公司不是一朝一夕就能建立起來的，我們的團隊經過多年的奉獻才取得了今天的地位。我感謝他們所有的辛勤工作，並且對團隊在業務各個方面的執行能力和卓越表現印象深刻。

The position we are in is truly unique, with eight approved products, three in-process product launches with long runways for growth, another potential product launch in the first quarter of 2026, multiple label expansion opportunities and a pipeline full of innovative candidates that are progressing towards market, the future has never been brighter for Eton.

我們目前的地位確實獨一無二，擁有八種已獲批准的產品、三種正在研發且具有長期成長潛力的產品、另一種可能在 2026 年第一季推出的產品、多種標籤擴展機會以及一系列正在向市場推出的創新候選產品，Eton 的未來從未如此光明。

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

說完這些，我將把它交給我們的財務長詹姆斯來討論財務問題。詹姆斯？

Thank you, Sean. Turning to our financial results. Our second quarter revenue was $18.9 million compared to $9.1 million in the second quarter of 2024, an increase of 108% and was comprised entirely of product sales.

謝謝你，肖恩。談到我們的財務結果。我們第二季的營收為 1,890 萬美元，而 2024 年第二季的營收為 910 萬美元，成長了 108%，並且全部由產品銷售構成。

The growth was driven primarily by increased sales of ALKINDI as well as the addition of INCRELEX and GALZIN, which were not included in the prior year period. As Sean mentioned, we now expect to achieve an $80 million annual revenue run rate in the third quarter of 2025, one quarter ahead of previous projections.

成長主要得益於 ALKINDI 銷量的成長以及 INCRELEX 和 GALZIN 的加入，這些在去年同期並未包括在內。正如肖恩所提到的，我們現在預計 2025 年第三季的年收入運行率將達到 8,000 萬美元，比之前的預測提前一個季度。

While we expect sequential revenue growth to continue, it will not be at as rapid of a pace as was seen from Q1 to Q2. The second quarter benefited from the first full quarter of INCRELEX revenue under Eton distribution, and at increased patient levels, so quarterly growth was more pronounced than it will be in the coming quarters.

雖然我們預計連續營收成長將持續，但速度不會像第一季到第二季那麼快。第二季度受益於 Eton 分銷下 INCRELEX 第一季的完整收入以及患者數量的增加，因此季度增長比未來幾季更為明顯。

Gross profit for the quarter was $11.9 million compared with $5.6 million in the prior year period due primarily to increased product sales. Adjusted gross profit, which excludes the impact of acquired inventory step-up adjustments and an intangible amortization was $14.1 million or 75% of total revenue versus $5.9 million of adjusted gross profit or 65% of total revenue in the prior year period.

本季毛利為 1,190 萬美元，去年同期為 560 萬美元，主要原因是產品銷售增加。調整後的毛利（不包括收購庫存遞增調整和無形攤銷的影響）為 1,410 萬美元，佔總收入的 75%，而去年同期的調整後毛利為 590 萬美元，佔總收入的 65%。

The improved adjusted gross margin profile was driven by continued growth of higher-margin ALKINDI SPRINKLE and the addition of higher-margin INCRELEX revenue. Our adjusted gross margin profile is expected to decline in the second half of this year as we transition to a new international distribution model for ex-US INCRELEX.

調整後毛利率的改善得益於高利潤率 ALKINDI SPRINKLE 的持續成長以及高利潤率 INCRELEX 收入的增加。隨著我們向美國以外 INCRELEX 的新國際分銷模式轉型，我們調整後的毛利率預計在今年下半年下降。

While the transfer price at which we supply product for ex-US markets is materially dilutive to corporate gross margin, we continue to expect to report full year 2025 adjusted gross margin of approximately 70% and for long-term adjusted gross margin to reach 75% by 2028. R&D expenses for the quarter were $3.7 million compared with $3.0 million in the prior year period.

雖然我們向美國以外市場供應產品的轉讓價格會大幅稀釋企業毛利率，但我們仍預計 2025 年全年調整後毛利率將達到約 70%，長期調整後毛利率到 2028 年將達到 75%。本季研發費用為 370 萬美元，去年同期為 300 萬美元。

The second quarter of 2025 included a $2.2 million NDA application fee related to the ET-600 submission and a $0.5 million licensing payment for Amglidia. General and administrative expenses for the quarter were $9.7 million compared with $5.6 million in the prior year period.

2025 年第二季包括與 ET-600 提交相關的 220 萬美元 NDA 申請費和 50 萬美元 Amglidia 許可費。本季的一般及行政開支為 970 萬美元，去年同期為 560 萬美元。

The increase was primarily driven by the expansion of our sales force, marketing costs associated with three product launches and increased compensation and benefit expenses associated with additional corporate headcount to support our growing portfolio.

成長的主要原因是銷售團隊的擴大、三款產品上市帶來的行銷成本以及為支持不斷增長的產品組合而增加的公司員工人數帶來的薪酬和福利費用的增加。

On an adjusted basis, which removes the impact of share-based compensation, transaction-related costs and other one-time expenses, G&A expense was $7.6 million compared to $4.9 million in the prior year period. We do not plan to make any additional significant investments into SG&A this year, and much of our planned 2025 marketing spend was heavily weighted in the first half of the year with our product launch efforts.

經過調整後，即剔除股權激勵、交易相關成本及其他一次性費用的影響，一般及行政管理費用為 760 萬美元，去年同期為 490 萬美元。我們今年不打算對銷售、一般及行政費用 (SG&A) 進行任何額外的重大投資，並且我們計劃的 2025 年營銷支出的大部分都集中在上半年的產品發布工作上。

So we expect adjusted G&A spending to remain flat or slightly decline for the remainder of 2025. We believe that the investments we've made over the past several quarters will support much higher revenue levels than where we are today. Adjusted EBITDA for the second quarter of 2025 was $3.1 million compared to negative $1.6 million in the second quarter of 2024.

因此，我們預計調整後的 G&A 支出在 2025 年剩餘時間內將保持穩定或略有下降。我們相信，過去幾季所做的投資將支持比現在更高的收入水平。2025 年第二季調整後 EBITDA 為 310 萬美元，而 2024 年第二季為負 160 萬美元。

Total company net loss was $2.6 million for the quarter compared to a net loss of $3.0 million in the prior year period. Net loss per basic and diluted share was $0.10 during the quarter compared to a net loss per basic and diluted share of $0.12 in the prior year period.

本季公司淨虧損總額為 260 萬美元，去年同期淨虧損為 300 萬美元。本季每股基本和稀釋後淨虧損為 0.10 美元，去年同期每股基本和稀釋後淨虧損為 0.12 美元。

On a non-GAAP basis, we reported net income of $1.5 million for the second quarter of 2025 compared to a net loss of $1.9 million in the prior year period, and diluted earnings per share of $0.03 for the second quarter of 2025 compared to a loss of $0.08 per basic and diluted share in the prior year period.

根據非公認會計準則 (Non-GAAP)，我們報告 2025 年第二季淨收入為 150 萬美元，而去年同期淨虧損為 190 萬美元；2025 年第二季每股攤薄收益為 0.03 美元，而去年同期每股基本收益和攤薄收益均為 0.08 美元。

Eton finished the second quarter with $25.4 million of cash on hand, and we generated $8 million of operating cash flow during the quarter. A $4.6 million payment from ESTEVE for the international rights to INCRELEX was received shortly after the end of Q2. So the company's cash balance as of today stands at more than $30 million. This concludes our remarks on second quarter results.

伊頓公學第二季末持有現金 2,540 萬美元，本季產生了 800 萬美元的營運現金流。第二季結束後不久，ESTEVE 支付了 460 萬美元，購買 INCRELEX 的國際版權。因此，截至今天，該公司的現金餘額已超過 3,000 萬美元。這就是我們對第二季業績的評論。

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

接下來，我們將把時間交給操作員進行問答。

(Operator Instructions) Chase Knickerbocker with Craig-Hallum.

（操作員指示）與 Craig-Hallum 一起追逐 Knickerbocker。

Good afternoon, congrats on the quarter and thanks for taking the questions. Sean, I just -- maybe to start on KHINDIVI. Can you kind of talk through the momentum that you've seen so far in the early stages of that launch and kind of what you're hearing from clinicians on that (technical difficulty) label?

下午好，恭喜本季取得的成績，感謝您回答問題。肖恩，我只是——也許從 KHINDIVI 開始。您能否談談在發布初期您看到的勢頭，以及您從臨床醫生那裡聽到的關於該（技術難度）標籤的評價？

And if we think about over the remainder of the year as far as what's possible from a volume's perspective, any way for us to kind of think about kind of patient growth for that franchise along with ALKINDI, kind of in the remainder of the year?

如果我們從銷售角度考慮今年剩餘時間的可能性，我們能否預見到該系列電影以及 ALKINDI 在今年剩餘時間裡能夠實現耐心成長？

Sure. Thanks, Chase, for the question. We have not broken out KHINDIVI and ALKINDI into separate buckets. I can say that some physicians have already instructed their offices to only -- for anybody of five and above that is on liquid, they will completely convert to -- I mean, to KHINDIVI. And we'll continue -- we've been adding patients on a weekly basis.

當然。謝謝 Chase 提出的問題。我們還沒有將 KHINDIVI 和 ALKINDI 分成不同的類別。我可以說，有些醫生已經指示他們的辦公室只對 5 歲及以上正在服用液體藥物的人進行全面改用 — — 我的意思是，改用 KHINDIVI。我們會繼續下去——我們每週都會增加患者。

That rate combined with ALKINDI SPRINKLE, we're pleased with. We think that we're going to exceed expectations on those two products as a combined, and we see we're very clearly on track to do more than $50 million.

價格與 ALKINDI SPRINKLE 的結合，讓我們感到很滿意。我們認為，這兩款產品的總銷售額將會超出預期，而且我們非常有望實現超過 5,000 萬美元的銷售額。

The real opportunity though, of course, will be when we can get the label expanded to include the four and below. That's where we really think the population and the majority of the sales will go. But yeah, I don't want to break out KHINDIVI and ALKINDI yet, but I can tell you that the launch is moving along.

當然，真正的機會在於我們可以將標籤擴展到包括四歲及以下。我們確實認為人口和大部分銷售額都會流向那裡。但是的，我還不想透露 KHINDIVI 和 ALKINDI 的消息，但我可以告訴你們，發布會正在進行中。

It's not going in -- unexpected. We get a majority or a very large proportion of the five and above. And we're not seeing a lot of conversions from going off of ALKINDI and going on to KHINDIVI. So right now, it seems to be more additive than anything else. We were, for a bit there, weren't sure if we would see a lot of conversions from ALKINDI to KHINDIVI, but that has not been the case.

這不會是意料之外的事。我們獲得了 5 個及以上人群的大多數或很大比例的支持。我們並沒有看到很多人從 ALKINDI 轉向 KHINDIVI。所以現在，它似乎比其他任何東西都更具附加作用。有一段時間，我們不確定是否會看到大量從 ALKINDI 到 KHINDIVI 的轉變，但事實並非如此。

Helpful color, Sean, thanks. And maybe on INCRELEX, can you share a little bit more on kind of what kind of trial design they were kind of discussing with you in that FDA meeting? I mean, was it something where they referred to kind of the original trial for INCRELEX? Was it something that -- something a little bit smaller and quicker would be sufficient? Just any general thoughts that came out of that meeting would be helpful to kind of think about the path forward for that.

有用的顏色，肖恩，謝謝。也許關於 INCRELEX，您能否分享更多關於他們在 FDA 會議上與您討論的試驗設計類型的信息？我的意思是，他們是否提到了 INCRELEX 的原始試驗？是不是只要規模小一點、速度快一點就夠了？會議中提出的任何一般性想法都將有助於思考未來的道路。

We believe we'll open up an IND where we'll be enrolling patients in between the -2 and the -3 standard deviations and that, that will be -- we'll be able to then go to doctors and tell them, look, if your patient isn't -- is -2, for example, where we have an open trial that patient can receive product under the IND. And our hope is that we can then place the product with that patient and still get reimbursed for it.

我們相信我們將開放一個 IND，我們將在其中招募介於 -2 和 -3 標準差之間的患者，這樣，我們將能夠 - 然後告訴醫生，看，如果您的患者不是 - 例如 -2，我們有一個開放試驗，患者可以根據 IND 接受產品。我們希望可以將該產品提供給該患者並獲得報銷。

So it would be an ongoing trial. Then at some point we would compile all that data and then put it in front of the agency. So it really depends on if the agency allows us to take that role. I'm kind of optimistic they will because it's already being used that way in Europe.

所以這將是一次持續的審判。然後，我們會在某個時候彙編所有這些數據，並將其提交給該機構。所以這實際上取決於該機構是否允許我們擔任該角色。我對此持樂觀態度，因為歐洲已經以這種方式使用了。

Got it. And as far as the kind of expectations for INCRELEX from here, obviously, we've had this big [bolus] initially upon launch. I mean what's the right way to think about it both in the remainder of the year and kind of if we look out, I mean, how quickly do you think we can get to this 185 patients?

知道了。至於人們對 INCRELEX 的期望，顯然，我們在推出之初就已經有了這個大的期望。我的意思是，在今年剩餘時間內，我們該如何正確思考這個問題？如果我們進行展望，您認為我們多快能達到 185 名患者的標準？

Is it something where it will be meaningfully slower now? Or is it something where we can still add 20, 30, 40 patients next year? Just trying to get a sense of how you're thinking about it.

現在它的速度會明顯變慢嗎？或者明年我們還能增加 20、30、40 名患者嗎？只是想了解一下您對此的看法。

(technical difficulty)

（技術難度）

Madison El-Saadi with B. Riley Securities.

麥迪遜·埃爾薩迪 (Madison El-Saadi) 與 B. Riley Securities 合作。

Hey guys, congrats on really, a great quarter. Thanks for taking our question. I guess two questions from me. Maybe could you help us understand where the beat came from across INCRELEX, GALZIN, and then ALKINDI, KHINDIVI?

嘿夥計們，恭喜你們度過了一個非常棒的季度。感謝您回答我們的問題。我想問兩個問題。也許您能幫助我們了解 INCRELEX、GALZIN、ALKINDI、KHINDIVI 的節拍來自哪裡？

It sounds like you really had outperformance across the board. But just wondering really if one drove it? And if you would -- if that's the expectation for second half, which product could really drive second half?

聽起來你的表現確實全面出色。但我只是想知道是否有人駕駛它？如果您願意—如果這是對下半年的預期，哪種產品能夠真正推動下半年的發展？

Hey Madison, this is James. Sean and David got cut off. Chase at Craig-Hallum, we'll get back to you on your question as well. But Madison, we still don't disclose product-specific revenue just from a competitive standpoint.

嘿，麥迪遜，我是詹姆斯。肖恩和大衛被打斷了。克雷格·哈勒姆 (Craig-Hallum) 的蔡斯 (Chase)，我們也會回答您的問題。但是麥迪遜，僅從競爭的角度來說，我們仍然不會透露特定產品的收入。

But per the -- all of the comments on INCRELEX exceeding expectations from a patient on therapy and an initial ramp, the beat is definitely heavily weighted toward INCRELEX, but we saw a growth in ALKINDI and GALZIN as well, but INCRELEX definitely led the way.

但根據 - 所有關於 INCRELEX 的評論，它超出了接受治療的患者的預期，並且初始療效有所提高，INCRELEX 的療效肯定是最佳的，但我們也看到了 ALKINDI 和 GALZIN 的增長，但 INCRELEX 絕對處於領先地位。

Got it. And then -- and maybe this is for Sean or David, whenever they get back.

知道了。然後——也許這是為肖恩或大衛準備的，無論他們什麼時候回來。

Yeah, we just got reconnected. Can you hear us?

是的，我們剛剛重新聯絡上了。你聽得到我們說話嗎？

Yes. Yes, we can. Just in time. Yeah. So, I guess regarding the FDA feedback, did they specify the 2 to 3 standard deviation range? And did they give any rationale for requesting this trial? I'm just wondering if you feel like you gained the clarity from them on really what the regulatory vehicle is going to be going forward? If it's going to be a typical kind of label update? Or is it going to be a prior approval submission?

是的。是的，我們可以。正好。是的。那麼，我猜測關於 FDA 的回饋，他們是否指定了 2 到 3 個標準差範圍？他們是否給出了要求進行這次審判的理由？我只是想知道，您是否覺得從他們那裡獲得了關於未來監管工具真正走向的清晰認知？這是否是典型的標籤更新？或是否需要事先批准提交？

Yeah. It will be an open IND is what we would like to do. And what that means is we could go to doctors today and the -- our sales reps should be able to say, if your patient is -2, which is the European standard, we have this open IND, you can enroll them in this also, and we would -- we hope we would get reimbursed for that, but it would be something that we could go and tell doctors to bring patients in. And we'd collect that data over a period of time and then provide that to the agency. But that is the European label.

是的。我們希望這將是一個開放的 IND。這意味著我們今天可以去看醫生，我們的銷售代表應該能夠說，如果你的病人是 -2，這是歐洲標準，我們有這個開放的 IND，你也可以讓他們參加，我們希望我們能得到報銷，但我們可以去告訴醫生帶病人來。我們會在一段時間內收集這些數據，然後提供給該機構。但那是歐洲的標籤。

So that's -- I don't see any reason why we couldn't do that. When we went to the Agency, we told them that's what we wanted to do. They said, come back to us with some sort of a proposal where we can -- you can collect some US clinical data. And right now, our consultants are saying that they're confident that, that would be acceptable to the agency.

所以——我看不出有什麼理由我們不能這麼做。當我們去該機構時，我們告訴他們這就是我們想要做的事情。他們說，請給我們一些建議，我們可以收集一些美國臨床數據。現在，我們的顧問表示，他們有信心該機構會接受這一點。

But we'll provide another update later this year, and we'll be able to tell you more in the quarters to come. I expect to get agreement on this though, in the fourth quarter, and then we would start right away with enrolling patients.

但我們將在今年稍後提供另一次更新，並將在未來幾季告訴您更多。我希望在第四季度就此達成協議，然後我們將立即開始招募患者。

Got it. Understood. That's helpful. Thanks.

知道了。明白了。這很有幫助。謝謝。

Sure. Pleasure.

當然。樂趣。

Chase Knickerbocker with Craig-Hallum.

與 Craig-Hallum 一起追逐 Knickerbocker。

Hey. Sorry, just one quick follow-up, maybe for James. Just on kind of back half ramp. Sorry if I missed this in your prepared remarks, but if I think about the back half ramp for OpEx, here the one-time items in R&D, I mean, any commentary as far as how we should think about the back half ramp in OpEx?

嘿。抱歉，我只想快速跟進一下，也許是針對詹姆斯的。就在後半坡道上。抱歉，如果我在您準備好的演講中遺漏了這一點，但如果我考慮 OpEx 的後半部分坡道，這裡是研發中的一次性項目，我的意思是，對於我們應該如何看待 OpEx 的後半部分坡道，有什麼評論嗎？

Yeah. With R&D, that will definitely -- we have the big filing fee, $2 million-plus filing fee in Q2 as well as $0.5 million licensing payment for Amglidia. So those obviously won't reoccur. And then from an SG&A standpoint, the big item that will change from H1 to H2 with the three product launches pretty much behind us at this point, that will be a pretty significant ramp down. So we don't anticipate while the -- we did go up a little bit on an adjusted basis from 7.3% to 7.6%, we expect to be at or below those levels second half of the year.

是的。有了研發，這肯定會——我們有大筆的申請費，第二季的申請費超過 200 萬美元，還有 50 萬美元的 Amglidia 許可費。所以這些顯然不會再發生。然後從銷售、一般及行政費用 (SG&A) 的角度來看，隨著三款產品的推出，從上半年到下半年的大項目將發生變化，這將是一個相當顯著的下降。因此，我們預計，雖然我們的成長率在調整後確實從 7.3% 略微上升至 7.6%，但我們預計今年下半年將達到或低於這些水準。

Got it. Thanks.

知道了。謝謝。

Swayampakula Ramakanth with H.C. Wainwright.

Swayampakula Ramakanth 與 H.C.溫賴特。

Thank you. Good afternoon, Sean and James. Just to talk a little bit about the KHINDIVI launch. You're stating that there are about 60% of the patients are age four and older. So --

謝謝。下午好，肖恩和詹姆斯。只是想簡單談談 KHINDIVI 的發布會。您說的是大約 60% 的患者年齡在 4 歲及以上。所以--

Four and below, I'm sorry --

四歲及以下，抱歉--

Sorry, four and below. Sorry, four and below. Yeah. I'm reading wrong from my notes. So in terms of getting this new formulation and to do the study, is this going to be -- how big of a study is that going to be? And in terms of timing, in general, how long does these sort of studies take?

抱歉，四歲以下。抱歉，四歲以下。是的。我讀到的筆記有誤。那麼，就獲得這種新配方並進行研究而言，這將是一項多大規模的研究？就時間而言，這類研究一般需要多久？

There's no study. We had to lower the excipient concentration. So we did that. We have to submit in, we believe, the first quarter, and then we hope to have approval of the wider label by the end of next year. So this is very quick. It was a slight modification of our existing formula, which was really easy to do.

沒有研究。我們必須降低賦形劑濃度。所以我們這麼做了。我們相信，我們必須在第一季提交申請，然後我們希望在明年年底之前獲得更廣泛的標籤的批准。所以這非常快。這是對我們現有公式的輕微修改，這真的很容易做到。

Okay. And then -- so let's say you get that all taken care of by the end of next year. So what sort of an additional patient number can you have -- can this drug be offered?

好的。然後——假設你在明年年底之前把所有事情都處理好了。那麼您可以獲得什麼樣的額外病患編號－可以提供這種藥物嗎？

Well, by itself, I mean, there's over 1,000 patients taking the oral suspension today. So, how quick that would ramp up? That's a good question. I guess we'll have to see. But there's no doubt in my mind. Once we have that one and combined with ALKINDI, we'll exceed 1,500 patients, probably 2,000 patients on product. That seems very achievable.

嗯，就其本身而言，我的意思是，今天有超過 1,000 名患者服用口服混懸液。那麼，這個速度會上升多快呢？這是個好問題。我想我們得拭目以待。但我心裡毫不懷疑。一旦我們有了這個產品並與 ALKINDI 結合，我們將有超過 1,500 名患者，大概有 2,000 名患者使用該產品。這看起來是可以實現的。

Fantastic. Thank you. Thanks for taking my questions.

極好的。謝謝。感謝您回答我的問題。

Our pleasure.

我們很高興。

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝大家的加入。您現在可以斷開連線。