Eton Pharmaceuticals Inc (ETON) 2024 Q3 法說會逐字稿

Good afternoon, and welcome to the Eton Pharmaceuticals third-quarter 2024 financial results conference call. (Operator Instructions)

下午好，歡迎參加 Eton Pharmaceuticals 2024 年第三季財務業績電話會議。 （操作員指示）

Please be advised that this call is being recorded at the company's request.

請注意，應公司要求，本次通話正在錄音。

At this time, I would 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 Eton Pharmaceuticals 首席商務官 David Krempa。請繼續。

Thank you, operator. Good afternoon, everyone, and welcome to Eton's third-quarter 2024 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. Joining me on our call today, we have Sean Brynjelsen, our CEO; and James Gruber, our CFO.

謝謝您，接線生。大家下午好，歡迎參加伊頓 2024 年第三季電話會議。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。今天與我們一起參加電話會議的還有我們的執行長 Sean Brynjelsen；以及我們的財務長 James Gruber。

In addition to taking live questions on today's call, we will be answering questions that are e-mailed to us. Investors can send their questions to investorrelations@etonpharma.com.

除了在今天的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 involve risks and uncertainties that could cause actual results to differ materially from those contained in these forward-looking statements. Please see the forward-looking statements disclaimer in our earnings release and the risk factors in the company's filings with the SEC. Now I will turn the call over to our CEO, Sean Brynjelsen.

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。現在我將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. It's been a busy and exciting few months for us, and I'm looking forward to talking with all of you today at such a critical moment in Eton's history. Throughout the last year, we have been talking about our three-pillar strategy: one, organic growth of our existing portfolio; two, advancement of internal pipeline products; and three, value-creating business development transactions to accelerate growth. I'm pleased to report that we have delivered major progress in all three of these pillars.

謝謝你，大衛。大家下午好，感謝大家今天的參與。對我們來說，過去的幾個月是忙碌而又令人興奮的，我期待著今天在伊頓歷史上如此關鍵的時刻與大家交談。在過去的一年裡，我們一直在談論我們的三大支柱策略：一、現有投資組合的有機成長；二是推動內部管線產品建設；三是創造價值的業務發展交易，以加速成長。我很高興地報告，我們在這三大支柱上都取得了重大進展。

First, our commercial organization continues to deliver attractive organic growth from our existing products, producing our 15th straight quarter of sequential product revenue growth. Secondly, the third quarter brought a critical milestone for our important pipeline product, ET-400, which was accepted for review by the FDA and assigned a February 28 PDUFA date. And lastly, on the business development front, we announced the signing of an asset purchase agreement to acquire Increlex last month, which represented a transformational opportunity for the company. I cannot be more proud of our team's hard work to achieve these results over the last few months, and I look forward to discussing each of these accomplishments in more detail. I'll start with our Q3 results.

首先，我們的商業組織繼續從現有產品中實現可觀的有機成長，連續第 15 個季度實現產品收入成長。其次，第三季我們的重要產品線產品 ET-400 迎來了一個關鍵的里程碑，該產品已被 FDA 接受審查，並指定了 2 月 28 日的 PDUFA 日期。最後，在業務發展方面，我們上個月宣布簽署資產購買協議以收購 Increlex，這對該公司來說是一個轉型機會。我對我們團隊在過去幾個月為取得這些成果所付出的努力感到無比自豪，我期待著更詳細地討論每項成就。我將從我們的第三季業績開始。

As I mentioned, we delivered another record quarter of product sales. Product sales were up 40% year over year and the growth continues to be driven by strong increases in both Alkindi Sprinkle and carglumic acid. The strong sales allowed us to reach positive GAAP net income in the third quarter. We previously said our goal was to reach GAAP net income by the fourth quarter of this year, so I am pleased that we were able to achieve it one quarter ahead of schedule. Reaching GAAP profitability is a major milestone for any company. In the pharmaceutical world, revenue and earnings are often the result of many years worth of investment in development activities.

正如我所提到的，我們本季的產品銷售額再創歷史新高。產品銷售額年增 40%，成長持續受到 Alkindi Sprinkle 和卡谷氨酸的強勁成長推動。強勁的銷售使我們在第三季實現了正的 GAAP 淨收入。我們之前說過，我們的目標是在今年第四季實現 GAAP 淨收入，所以我很高興我們能夠提前一個季度實現這一目標。實現 GAAP 盈利對於任何公司來說都是一個重要的里程碑。在製藥業，收入和收益通常是多年開發活動投資的結果。

Our case is no different as we are starting to see the fruits of our labor after many years spent working hard on drug development and regulatory activities, building out our commercial infrastructure and evaluating business development opportunities. we expect much more to come in the months and years ahead. Profitability has always been and always will be a central part of our strategy at Eton.

我們的情況也不例外，經過多年努力進行藥物開發和監管活動、建立商業基礎設施和評估業務發展機會，我們開始看到勞動成果。我們期待在未來的幾個月和幾年裡會有更多事情發生。獲利能力一直是並且永遠是伊頓公司策略的核心部分。

We are not interested in chasing unprofitable growth. We have worked tirelessly to produce attractive revenue growth, while maintaining a disciplined cost structure. This approach has allowed us to reach a cash flow breakeven in 2023 and now positive GAAP income this quarter.

我們對追求無利可圖的成長不感興趣。我們不懈努力，實現可觀的收入成長，同時保持嚴格的成本結構。這種方法使我們在 2023 年實現了現金流收支平衡，並且本季實現了正的 GAAP 收入。

By closely monitoring our spending, we have been able to build up Eton's attractive rare disease portfolio and pipeline, while minimizing dilution to shareholders. We are very pleased to have reached this critical profitability milestone for the company, but we are far from finished. In fact, I think we are in the early stages of our growth story with the expected additions of Increlex and ET-400 on top of continued growth from our existing portfolio, we are very excited about what we expect to deliver in 2025.

透過密切監控我們的支出，我們已經能夠建立 Eton 具有吸引力的罕見疾病產品組合和產品線，同時最大限度地減少對股東的稀釋。我們非常高興公司達到了這一關鍵的獲利里程碑，但我們還遠遠沒有完成。事實上，我認為我們正處於成長故事的早期階段，預計在現有產品組合持續成長的基礎上增加 Increlex 和 ET-400，我們對 2025 年的預期成果感到非常興奮。

During our last call, I had mentioned that I was optimistic about acquiring a larger commercial asset this year. And we were pleased to see it materialize last month when we announced that we have signed an asset purchase agreement with Ipsen for the purchase of Increlex. Increlex is an FDA and EMA approved product for the treatment of severe primary insulin-like growth factor 1 deficiency. It is an attractive biologic product that fits perfectly with our pediatric endocrinology focus.

在我們上次通話中，我曾提到我對今年收購更大的商業資產感到樂觀。上個月，當我們宣布與益普生簽署資產購買協議以收購 Increlex 時，我們很高興看到這一目標得以實現。 Increlex 是經 FDA 和 EMA 批准的用於治療嚴重原發性胰島素樣生長因子 1 缺乏症的產品。這是一種極具吸引力的生物製品，與我們的兒科內分泌學重點完美契合。

With our strong presence and relationships in pediatric endocrinology community, we believe we can raise awareness of this condition, which appears to be both underdiagnosed and undertreated. We plan to finance the acquisition entirely with cash on hand and an expansion of our existing credit facility. The transaction is expected to close towards the end of this year, and we will be able to share more about the product and our expectations for after the transaction closes.

憑藉我們在兒科內分泌學界的強大影響力和良好的關係，我們相信我們可以提高人們對這種疾病的認識，這種疾病似乎既未被充分診斷​​，也未得到充分治療。我們計劃利用現有現金和擴大現有信貸額度來為此次收購提供資金。該交易預計將於今年年底完成，我們將能夠分享更多有關該產品以及我們對交易完成後的期望的資訊。

In order to help support the addition of Increlex as well as the expected near-term launch of ET-400, we are planning an expansion and realignment of our sales force in 2025. Our current sales force will be split into two separate units with approximately 12 rare disease specialists focused on pediatric endocrinology, promoting Increlex Alkindi Sprinkle and ET-400 and additional 5 specialists will focus exclusively on our metabolic portfolio, promoting Carglumic Acid, PKU GOLIKE, Betaine and Nitisinone. We believe this realignment will allow us to maximize the revenue potential of our entire product portfolio.

為了幫助支持 Increlex 的加入以及預計近期推出的 ET-400，我們計劃在 2025 年擴大和調整我們的銷售團隊。我們目前的銷售隊伍將分為兩個獨立的部門，其中約 12 名罕見疾病專家專注於兒科內分泌學，推廣 Increlex Alkindi Sprinkle 和 ET-400，另外 5 名專家將專注於我們的代謝產品組合，推廣 Carglumic Acid、PKU GOLIKE、甜菜鹼和 Nitisinone。我們相信，這項調整將使我們能夠最大限度地發揮整個產品組合的收入潛力。

Now on to our product-specific results. Alkindi Sprinkle revenue and active patients continue to grow and even with a higher discontinuation rate than we would like, the product delivered 55% year-over-year growth and has a long runway ahead of it. The product is patent protection through 2034, and we believe that roughly 90% of the target population has yet to be converted. Despite the current growth rate, we expect the franchise's growth trajectory to accelerate with the launch of ET-400 next year.

現在來看看我們特定產品的結果。 Alkindi Sprinkle 的收入和活躍患者持續成長，即使停藥率高於我們的預期，該產品仍實現了 55% 的同比增長，並且前景廣闊。該產品的專利保護期至 2034 年，我們認為約 90% 的目標族群尚未轉變。儘管目前的成長率很高，但我們預計隨著明年 ET-400 的推出，該系列的成長軌跡將會加速。

We remain confident that the combined products can reach an active patient count that is significantly higher than the current level. Regarding our metabolic portfolio, we saw another nice quarter of revenue growth, driven primarily by Carglumic Acid. PKU GOLIKE continues to see strong interest since our acquisition earlier this year. We have seen an increase in referrals since we reengaged promotional activities in the second quarter, and we believe that having a fully dedicated metabolic sales force plus the anticipated launch of tyrosinemia GoLike early next year will lead to significant growth in this franchise in 2025.

我們仍然相信，合併後的產品可以達到比目前水準明顯更高的活躍患者數量。關於我們的代謝產品組合，我們看到另一個季度的收入成長良好，主要由卡谷氨酸推動。自從今年稍早被我們收購以來，PKU GOLIKE 一直受到人們的強烈關注。自從我們在第二季度重新開展促銷活動以來，我們看到推薦量有所增加，我們相信，擁有一支全心投入的代謝銷售隊伍，加上預計明年年初推出的酪氨酸血症 GoLike，將使該特許經營權在 2025 年實現顯著增長。

Moving on to our pipeline candidates. During the quarter, we received the exciting news that the FDA has accepted our new drug application for ET-400, a proprietary patented formulation of hydrocortisone oral solution and assigned a PDUFA's action date of February 28, 2025. We are now more than 6 months into the review of the application, and we believe that it is going well. As a result, we have scheduled the manufacturing of initial launch inventory later this quarter. This will enable us to have commercial product available shortly after the potential FDA approval.

接下來是我們的候選人。在本季度，我們收到了令人興奮的消息，FDA 已經接受了我們針對 ET-400 的新藥申請，ET-400 是一種專有專利配方的氫化可的鬆口服溶液，並指定了 PDUFA 的行動日期為 2025 年 2 月 28 日。我們現在對該申請的審查已經進行了 6 個多月，我們相信進展順利。因此，我們計劃在本季稍後生產首批上市庫存。這將使我們能夠在獲得 FDA 批准後不久推出商業產品。

Our team is hard at work on all other aspects of launch preparation, including our marketing campaign. In addition, last week, we received good news that the US Patent and Trademark Office granted us a second patent for ET-400, further strengthening our IP protection on this important product. On to ET-600, where our pivotal study has now been initiated, this study should be completed relatively quickly, and we anticipate having an initial data readout near the end of this year. If successful, this will allow us to file the products NDA by the end of the first quarter in 2025.

我們的團隊正在努力做好發布準備的所有其他方面，包括我們的行銷活動。此外，上週我們收到好消息，美國專利商標局授予我們ET-400的第二項專利，進一步加強了我們對這項重要產品的智慧財產權保護。對於 ET-600，我們的關鍵研究現已啟動，這項研究應該會相對較快地完成，我們預計將在今年年底前獲得初步數據讀數。如果成功，我們將能夠在 2025 年第一季末之前提交產品 NDA。

As you may recall, we previously ran and passed a pilot study in the first part of this year, so we are optimistic about the outcome of this pivotal study. And with Increlex now further bolstering our pediatric endocrinology presence, we are very excited about the prospects for ET-600. If everything goes as planned, ET-600 will be our fourth commercial pediatric endocrinology product and could be on the market as early as the first quarter of 2026.

您可能還記得，我們​​曾在今年上半年進行過一項試點研究並通過了，因此我們對這項關鍵研究的結果感到樂觀。隨著 Increlex 進一步增強我們在兒科內分泌學領域的地位，我們對 ET-600 的前景感到非常興奮。如果一切按計劃進行，ET-600 將成為我們的第四款商業兒科內分泌產品，最快可能在 2026 年第一季上市。

As you've seen from our results, we are executing on all fronts. I am proud of the team for delivering another stellar quarter of financial results that resulted in GAAP net income, making progress advancing our pipeline candidates and executing a transformational acquisition. I could not be more excited for how we are positioned entering 2025.

正如您從我們的結果中看到的，我們正在各個方面努力執行。我為團隊感到自豪，他們又一次取得了出色的財務業績，實現了 GAAP 淨收入，在推進我們的候選藥物研發方面取得了進展，並執行了一項轉型收購。我對於我們進入 2025 年的定位感到無比興奮。

With all of this progress, we are well on our way to reaching our three long-term goals for the company. That is 10 commercial rare disease products with Increlex and potential near-term launches of ET-400 and ET-600, we have a clear path to eight. We hope to have additional commercial products in 2025. Secondly, reaching $100 million in revenue, the expected launches of both ET-400 and Increlex should put us on a trajectory path to achieve this in the near term.

憑藉所有這些進展，我們正在順利實現公司的三大長期目標。我們已經擁有 10 種商業罕見疾病產品，包括 Increlex 和可能在近期推出的 ET-400 和 ET-600，我們已經有明確的路線圖來達到 8 種。我們希望在 2025 年推出更多商業產品。其次，達到 1 億美元的收入，ET-400 和 Increlex 的預期推出應該會讓我們走上在短期內實現這一目標的軌道。

Thirdly, reaching a $1 billion market cap. If we're successful in delivering on our strategy on these first 2 goals and developing and launching new products and continuing to execute value-creating acquisitions we believe we can reach this milestone in the coming years. We appreciate all of our shareholder support, and we continue to believe big things are ahead for Eton.

第三，達到10億美元的市值。如果我們成功實現這兩個目標的策略，開發和推出新產品，並繼續執行創造價值的收購，我們相信我們能夠在未來幾年內實現這一里程碑。我們感謝所有股東的支持，我們始終相信伊頓未來將會取得巨大成功。

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

說完這些，我將把話題交給我們的財務長詹姆斯來討論財務問題。詹姆斯？

Thank you, Sean. Our third quarter revenue was $10.3 million compared to $7.0 million in the third quarter of 2023. Revenue for the third quarter of 2024 included $0.5 million of licensing revenue resulting from the sale of our DS-200 product candidate in September of 2024, and we reported 0 licensing revenue in the third quarter of 2023. Net product sales for the third quarter of 2024 increased 40% to $9.8 million compared to $7.0 million in the prior year period, primarily driven by growth in Alkindi Sprinkle and Carglumic Acid. R&D expenses for the quarter were $0.5 million compared with $0.6 million in the prior year period as overall development activities were relatively flat year-over-year.

謝謝你，肖恩。我們第三季的營收為 1,030 萬美元，而 2023 年第三季為 700 萬美元。 2024 年第三季的收入包括 2024 年 9 月出售 DS-200 候選產品所產生的 50 萬美元的授權收入，而我們報告 2023 年第三季的授權收入為 0。2024 年第三季的淨產品銷售額較去年同期的 700 萬美元成長 40% 至 980 萬美元的主要成長得。本季研發費用為 50 萬美元，而去年同期為 60 萬美元，因為整體開發活動與去年同期相比基本持平。

General and administrative expenses for the quarter were $5.3 million compared with $4.3 million in the prior year period, due primarily to increased sales and marketing activities, legal expenses and employee-related expenses. Total company net income was $0.6 million for the quarter compared to a net loss of $0.6 million in the prior year period.

本季的一般及行政支出為 530 萬美元，而去年同期為 430 萬美元，主要原因是銷售和行銷活動、法律費用和員工相關費用增加。本季公司淨收入總額為 60 萬美元，而去年同期淨虧損為 60 萬美元。

Net income per basic and diluted share during the quarter was $0.02 compared to a net loss per basic and diluted share of $0.02 in the prior year period. It is worth noting that even without the profit associated with onetime licensing revenue this quarter, Eton still generated positive net income, which as Sean mentioned, is a very important milestone for the company. Eton finished the third quarter with $20.3 million of cash on hand and generated $2.9 million of operating cash flow during the quarter.

本季基本每股淨利潤和稀釋每股淨虧損均為 0.02 美元，而去年同期基本每股淨虧損和稀釋每股淨虧損均為 0.02 美元。值得注意的是，即使本季沒有一次性授權收入相關的利潤，Eton 仍然產生了正淨收入，正如 Sean 所提到的，這對公司來說是一個非常重要的里程碑。伊頓公學第三季末持有現金 2,030 萬美元，並在本季產生了 290 萬美元的營運現金流。

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

這就是我們對第三季業績的評論。說完這些，我將把時間交還給操作員進行問答。

(Operator Instructions)

（操作員指示）

Chase Knickerbocker, Craig-Hallum.

蔡斯·尼克博克、克雷格·哈勒姆。

Congrats on all the progress here. Obviously, you guys are well familiar with many of the potential and current prescribers of Increlex. Can you kind of let us in on what you heard from them as you were kind of doing your work on the product that got you very interested to pursue the deal. Just kind of any color on kind of your due diligence there that got you really excited?

恭喜你在這裡取得的所有進展。顯然，你們對 Increlex 的許多潛在和現有處方者都很熟悉。您能否告訴我們，當您對產品進行研究時，您從他們那裡聽到了什麼，這讓您非常有興趣達成這筆交易。您的盡職調查是否讓您感到非常興奮？

Thanks, Chase. So we won't be able to go too much into it before the deal closed. But obviously, we're very excited talking about the opportunity. As you mentioned, we know a lot of the doctors. We've talked to them they've said it's a very good product. It's a needed product. There's no other alternatives for these children.

謝謝，蔡斯。因此在交易完成之前我們不能透露太多。但顯然，我們對這個機會感到非常興奮。正如您所說，我們認識很多醫生。我們與他們交談過，他們說這是一款非常好的產品。這是必需的產品。這些孩子沒有其他選擇。

So it was a critical product. They wanted to make sure we kept it on the market and available to all these patients. I think they thought there was an opportunity for even more education and awareness within the community, and that's what we intend to do. We think we've got a good presence, given relationships with the community, and we look forward to increasing the awareness education and we think the treatment within the population.

所以它是一款關鍵產品。他們希望確保我們能夠將其投放到市場上並供所有患者使用。我認為他們認為這是一個在社區內進行更多教育和提高意識的機會，而這正是我們打算做的。我們認為，鑑於與社區的關係，我們已經擁有了良好的聲譽，我們期待提高人們的認識教育，並考慮在人群中進行治療。

Great. And then to the extent that you can kind of before closing, first, kind of how we can think about Increlex on the top line under Eton ownership. It looks to be fairly -- it have been fairly steady with some kind of recent fluctuations under Ipsen. Any thoughts on what you guys can do to potentially return the product to growth? And then on the expense side, how should investors think about kind of SG&A needing to increase as a result of this transaction?

偉大的。然後，在結束之前，您可以先考慮在 Eton 所有權下，Increlex 的營收情況。它看起來相當穩定，除了最近在益普生 (Ipsen) 的領導下出現一些波動之外。你們有什麼想法可以做些什麽來讓產品恢復成長？那麼在費用方面，投資者應該如何看待由於這筆交易而需要增加的銷售、一般和行政費用？

Chase, this is Sean. So on the top line, we certainly got, I think, a little bit less than what we have done historically. But the plan here is we have a dedicated sales team that is bringing that product really back to the forefront of these doctors' minds as they have patients come in growth issues that Increlex is another tool within their bag, they can use to treat them. We know that at one point, there was just under 200 patients on product, and we think we can get back to that just by simple promotion and education and hopefully, the doctors will take the diagnose and administer it more broadly.

蔡斯，這是肖恩。因此，就營收而言，我認為我們的收入肯定比歷史上少一些。但這裡的計劃是，我們有一個專門的銷售團隊，讓產品真正重新回到這些醫生的腦海中，因為他們的患者出現生長問題，而 Increlex 是他們包中的另一種工具，他們可以使用它來治療。我們知道，在某一時刻，使用該產品的患者人數略低於 200 名，我們認為，只需透過簡單的推廣和教育，我們就能恢復到這一水平，並希望醫生能夠接受診斷並更廣泛地應用該產品。

So we're looking at that as one lever. At some point, we'll see Europe has far more patients than the US and we'll have to figure out what's going on there and how that perhaps we can understand that perhaps to grow the market above the 200 patients. But those would be the initial steps.

因此我們將其視為一個槓桿。在某個時候，我們會看到歐洲的患者數量遠遠超過美國，我們必須弄清楚那裡發生了什麼，以及如何才能理解這一點，或許可以將市場規模擴大到 200 名患者以上。但這些只是初步步驟。

Our plans also include putting together an advisory board of medical doctors and leading health care providers that understand the disease state and will help us to make sure that patients are number one. Because the other company is patients first, then products and then services, patient support services in their order we want to help as much as we can. And then the second part of your question regarding the expenses. I guess, I'll let either -- maybe James, do you want to take that one?

我們的計劃還包括組成一個由醫生和領先的醫療保健提供者組成的顧問委員會，他們了解疾病狀況並幫助我們確保患者是第一位的。因為其他公司首先考慮的是患者，然後是產品、服務、患者支援服務，我們希望盡可能提供協助。然後是你問題的第二部分，關於費用。我想，我會讓任何一個——也許詹姆斯，你想接受那個嗎？

Chase. Regarding SG&A, as Sean mentioned in his remarks, here in the U.S., we are going to increase by the -- we're expanded sales force. So there'll be additional investment there. As David mentioned, there will be additional investment in market education to a decent amount of investment here in the United States. And then outside the US, a decent amount of investment in ex-US infrastructure, logistics, decent amount of regulatory investment. So after the deal closes, we'll provide a little more detail behind specific 2025, but decent amount of investment expected next year.

追趕。關於銷售、一般及行政費用，正如肖恩在演講中提到的，在美國，我們將增加——我們正在擴大銷售團隊。因此那裡將會有額外的投資。正如大衛所提到的，美國將在市場教育方面追加相當數量的投資。在美國以外，對美國以外的基礎設施、物流和監管投資也進行了相當數量的投資。因此，交易結束後，我們將提供更多關於 2025 年具體情況的細節，但預計明年的投資金額將相當可觀。

Got it. And then on Carglumic. I mean, you noted sequential growth again. Did you add a couple more patients in the quarter? And kind of do you think that growth can kind of continue sequentially? And then Sean, any engagement with FDA on ET-400 in the quarter? Or kind of what informs kind of the confidence that you mentioned in prepared remarks?

知道了。然後是 Carglumic。我的意思是，您再次注意到了連續成長。本季您是否又增加了幾位患者？您認為這種成長能夠持續下去嗎？那麼肖恩，本季與 FDA 就 ET-400 有任何合作嗎？或者您在準備好的發言中提到的信心是怎樣的？

Sure. On Carglumic, maybe James, do you want to speak to that in terms of the sales revenue.

當然。關於 Carglumic，也許詹姆斯，你想從銷售收入的角度來談談這個問題。

Yes. We've had -- it's been a great contributor of revenue growth for us to date. We've overachieved what we expected to from a market share standpoint. So while additional growth is certainly possible. The reason we've built up our internal pipeline has been so active in every day, is to bolster the product portfolio with additional products because we're never going to say the product is not going to continue to grow, but it's got limited opportunity from a go forward standpoint.

是的。我們已經——到目前為止，它一直是我們收入成長的巨大貢獻者。從市場佔有率的角度來看，我們已經超出了預期。因此，雖然額外的增長肯定是可能的。我們建立內部管道並使其每天都如此活躍的原因是為了透過增加產品來增強產品組合，因為我們永遠不會說產品不會繼續成長，但從前進的角度來看，它的機會有限。

I think that's fair. And really as we go forward with these new opportunities, we're looking at patent protect, and I projected true branded products and really hitting unmet needs. Carglumic, as you know, is an AB-rated version of Carbaglu. So that offers I guess another option for patients, but it wasn't really filling an unmet need as Carbaglu met that. With need met, it's really just offering a lower price.

我認為這是公平的。當我們真正抓住這些新機會時，我們正在尋求專利保護，我預測真正的品牌產品將真正滿足尚未滿足的需求。如您所知，Carglumic 是 Carbaglu 的 AB 級版本。所以我認為這為患者提供了另一種選擇，但它並沒有真正滿足未滿足的需求，因為 Carbaglu 滿足了這一需求。在滿足需求的情況下，它實際上只是提供更低的價格。

But our real [action] here is to bring in products that can address unmet needs. Like I always say, there's over 5,000 rare diseases, most of which are ultrarare, that's the work we like to do. And to that point, ET-400 review is going very well in my opinion. We don't have any open items at this time. And we're expecting labeling in the near future. So once the label income and start coming in, we feel pretty good about the February 20 PDUFA day.

但我們真正的行動是引進能夠滿足未滿足需求的產品。就像我常說的，罕見疾病有 5,000 多種，其中大多數是極其罕見的，這就是我們喜歡做的工作。就這一點而言，我認為 ET-400 的評測進展非常順利。我們目前沒有任何未結項。我們期待在不久的將來推出標籤。因此，一旦標籤收入開始流入，我們對 2 月 20 日的 PDUFA 日感到非常滿意。

(Operator Instructions)

（操作員指示）

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

我們的問答到此結束。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。