Eton Pharmaceuticals Inc (ETON) 2023 Q2 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good afternoon, and welcome to Eton Pharmaceuticals' second-quarter 2023 financial results conference call. (Operator Instructions)

    下午好,歡迎參加 Eton Pharmaceuticals 2023 年第二季度財務業績電話會議。 (操作員說明)

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

    請注意,本次通話是應公司要求進行錄音的。

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

    這次,我想把它交給 Eton Pharmaceuticals 首席商務官 David Krempa。請繼續。

  • David Krempa - Chief Business Officer

    David Krempa - Chief Business Officer

  • Thank you, operator. Good afternoon, everyone, and welcome to Eton's second quarter of 2023 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.

    謝謝你,接線員。大家下午好,歡迎參加伊頓公學 2023 年第二季度電話會議。今天下午,我們發布了一份新聞稿,概述了我們計劃在今天的電話會議上討論的主題。該新聞稿可在我們的網站 etonpharma.com 上獲取。

  • Joining me on our call today, we have Sean Brynjelsen, our CEO; and James Gruber, our CFO. In addition to taking live questions on today's call, we will be answering questions that are e-mailed to us. You can send your questions to Investor Relations at etonpharma.com.

    今天加入我們的電話會議的有我們的首席執行官 Sean Brynjelsen;和我們的首席財務官詹姆斯格魯伯。除了在今天的電話會議上回答實時問題外,我們還將回答通過電子郵件發送給我們的問題。您可以將問題發送至 etonpharma.com 的投資者關係部。

  • 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.

    在開始之前,我想提醒大家,今天電話會議中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包含的結果存在重大差異。請參閱我們的收益報告中的前瞻性聲明免責聲明以及公司向 SEC 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首席執行官 Sean Brynjelsen。

  • Sean Brynjelsen - CEO & Director

    Sean Brynjelsen - CEO & Director

  • Thank you, David. Good afternoon, everyone, and thank you for joining us today. Second quarter was another exceptional quarter for Eton. We delivered record product sales of ALKINDI SPRINKLE and carglumic acid. We launched our third commercial product, betaine anhydrous, and we also recorded positive cash flow and net income. It was our 10th straight quarter of sequential product growth.

    謝謝你,大衛。大家下午好,感謝您今天加入我們。第二季度對伊頓公學來說又是一個特殊的季度。我們的 ALKINDI SPRINKLE 和卡格魯酸產品銷量創歷史新高。我們推出了第三種商業產品無水甜菜鹼,我們還錄得正現金流和淨利潤。這是我們產品連續第十個季度實現增長。

  • As a result of the soft performance through the first half of this year, we are now increasing our revenue expectation for 2023. We expect total 2023 revenue of approximately $30 million. During the second quarter, total revenue was $12 million and net income was $4.6 million. Product sales and royalty revenue were $6.5 million for the quarter, up 176% from the second quarter of 2022 and up 22% sequentially from the first quarter of 2023.

    由於今年上半年業績疲軟,我們現在提高了 2023 年的收入預期。我們預計 2023 年總收入約為 3000 萬美元。第二季度總收入為 1200 萬美元,淨利潤為 460 萬美元。本季度產品銷售額和特許權使用費收入為 650 萬美元,較 2022 年第二季度增長 176%,較 2023 年第一季度環比增長 22%。

  • For ALKINDI, our expanded sales force and our direct-to-consumer marketing campaign have continued to help increase engagement with the adrenal insufficiency community. We continue to add patients each week, and our goal is to reach 400 active patients by the end of the year. Even with this fast rate of growth and significant patient base, we are still in the very early stages of the ALKINDI growth story.

    對於 ALKINDI 來說,我們擴大的銷售隊伍和直接面向消費者的營銷活動繼續幫助增加與腎上腺功能不全社區的互動。我們每週都會繼續增加患者,我們的目標是到年底達到 400 名活躍患者。儘管增長速度如此之快,患者基礎也如此龐大,但我們仍處於 ALKINDI 增長故事的早期階段。

  • With an estimated total pediatric adrenal insufficiency patient population of 10,000 patients, a very large percentage of the market has yet to convert. We believe ALKINDI SPRINKLE on its own should continue to convert a significant portion of this market in the coming months and years. However, our ET-400 product is expected to turbocharge this effort when it is launched.

    據估計,兒科腎上腺功能不全患者總數為 10,000 名,其中很大一部分市場尚未轉化。我們相信 ALKINDI SPRINKLE 本身應該會在未來幾個月和幾年內繼續佔據該市場的很大一部分。然而,我們的 ET-400 產品預計在推出後將進一步推動這一努力。

  • ET-400 will be sold along ALKINDI SPRINKLE as a new liquid dosage form of hydrocortisone. Patients will choose to take either ALKINDI SPRINKLE or ET-400. ET-400's proprietary patent-pending formulation will address the texture issue that some young patients have reported with sprinkles. And in addition, it will help us convert a large portion of the patient population that is currently using unapproved compounded suspensions.

    ET-400 將作為氫化可的鬆的新液體劑型與 ALKINDI SPRINKLE 一起銷售。患者將選擇服用 ALKINDI SPRINKLE 或 ET-400。 ET-400 正在申請專利的專有配方將解決一些年輕患者報告的噴灑質地問題。此外,它將幫助我們改變目前使用未經批准的複合混懸劑的大部分患者群體。

  • We expect the combined peak sales of ET-400 and ALKINDI SPRINKLE to exceed $50 million annually. We plan to submit the NDA for ET-400 at the end of this year, which should allow for an approval and commercial launch in late 2024.

    我們預計 ET-400 和 ALKINDI SPRINKLE 的年度峰值銷售額合計將超過 5000 萬美元。我們計劃在今年年底提交 ET-400 的 NDA,這將允許在 2024 年底獲得批准和商業推出。

  • Moving now to carglumic acid. Carglumic acid has also had a very strong quarter and the product revenue continues to benefit from our expanded sales force. Our product has continuously outperformed our own expectations, and we remain optimistic that the product will continue to grow nicely for the foreseeable future.

    現在轉向卡魯酸。卡格酸也有一個非常強勁的季度,產品收入繼續受益於我們擴大的銷售隊伍。我們的產品不斷超出我們自己的預期,我們仍然樂觀地認為該產品在可預見的未來將繼續良好增長。

  • We also launched betaine anhydrous in May, which shares the same prescriber base as carglumic. The betaine launch has increased our interactions with metabolic geneticists and helped us gain access to some hard-to-reach carglumic prescribers.

    我們還在五月份推出了無水甜菜鹼,它與卡魯米克具有相同的處方基礎。甜菜鹼的推出增加了我們與代謝遺傳學家的互動,並幫助我們接觸到一些難以接觸到的卡格魯米處方者。

  • The betaine launch is progressing well. We are now three months into the launch and have seen significant adoption. We've heard positive feedback both for patients and prescribers that are very appreciative to be able to enroll in our Eton Cares patient support services.

    甜菜鹼的推出進展順利。我們現在已經推出三個月了,並且已經得到了廣泛的採用。我們聽到了患者和處方醫生的積極反饋,他們非常感謝能夠參加我們的 Eton Cares 患者支持服務。

  • While betaine is the smallest of our three current products, once ramped up, we expect it to contribute multiple millions of revenue annually with minimal incremental costs or resource usage.

    雖然甜菜鹼是我們現有三種產品中最小的,但一旦產量增加,我們預計它每年將以最小的增量成本或資源使用貢獻數百萬美元的收入。

  • Before we move on, let me address the recent CRL we received for dehydrated alcohol. The CRL is primarily related to chemistry manufacturing control items as well as some minor labeling comments. The good news is we do not see a need to conduct additional laboratory activities to address these comments.

    在我們繼續之前,讓我先談談我們最近收到的無水酒精 CRL。 CRL 主要與化學生產控制項目以及一些次要的標籤註釋相關。好消息是我們認為沒有必要進行額外的實驗室活動來解決這些評論。

  • We intend to file a response over the coming months, but we think the FDA's issues are addressable. We are disappointed to not have the revenue from this product this year. However, the outperformance in our other products has more than made up for most of the alcohol revenue we were anticipating in 2023. We expect our existing product sale to allow us to reach the cash flow breakeven around the end of this year.

    我們打算在未來幾個月內提交回應,但我們認為 FDA 的問題是可以解決的。我們對今年沒有從該產品獲得收入感到失望。然而,我們其他產品的優異表現足以彌補我們在 2023 年預期的大部分酒精收入。我們預計現有產品銷售將使我們能夠在今年年底左右實現現金流收支平衡。

  • During the quarter, we saw progress with the development of ET-600, which is another innovative product candidate that shares ALKINDI's user base. Physicians have repeatedly expressed the need for this product, which we treat a rare pediatric endocrinology condition called diabetes insipidus. Registration batches have been successfully manufactured so we expect to file the NDA in the middle of 2024.

    本季度,我們看到 ET-600 的開發取得了進展,這是另一個與 ALKINDI 擁有相同用戶群的創新產品候選者。醫生們多次表達了對這種產品的需求,我們用它來治療一種罕見的兒科內分泌疾病,稱為尿崩症。註冊批次已成功生產,因此我們預計在 2024 年中期提交 NDA。

  • While our existing commercial products and pipeline are expected to provide us with a long runway of organic growth for many years to come, we continually and aggressively pursue acquisition opportunities to expand our rare disease portfolio even further. We are excited about the prospects for transactions in the coming quarters for three important reasons.

    雖然我們現有的商業產品和管道預計將為我們在未來許多年提供長期的有機增長,但我們將不斷積極地尋求收購機會,以進一步擴大我們的罕見疾病產品組合。由於三個重要原因,我們對未來幾個季度的交易前景感到興奮。

  • First, our financial position has never been better. We finished the quarter with more than $21 million of cash, one of our highest levels ever. And more importantly perhaps, we expect to reach cash flow breakeven within the coming months. This means that nearly all of our cash balance is excess cash that can be put towards acquiring rare disease products.

    首先,我們的財務狀況從未如此好。本季度結束時,我們的現金超過 2100 萬美元,這是我們有史以來的最高水平之一。也許更重要的是,我們預計在未來幾個月內實現現金流收支平衡。這意味著我們幾乎所有的現金餘額都是多餘的現金,可以用來購買罕見疾病產品。

  • Secondly, we are seeing an increasing number of distressed sellers. Due to the challenging capital markets environment, many of our peers are struggling to raise capital. As a result, many companies are no longer able to raise the money needed to commercialize assets. Many others are seeking to sell off products to raise capital or even filing for bankruptcy.

    其次,我們看到陷入困境的賣家越來越多。由於資本市場環境充滿挑戰,我們的許多同行都在努力籌集資金。結果,許多公司不再能夠籌集資產商業化所需的資金。許多其他人正在尋求出售產品來籌集資金,甚至申請破產。

  • We have already seen a number of attractive assets up for sale from distressed sellers. And we expect to see even more in the coming quarters. With a strong financial position, we believe we are very well positioned to take advantage of these types of opportunities.

    我們已經看到許多有吸引力的資產被陷入困境的賣家出售。我們預計在未來幾個季度會看到更多。憑藉強大的財務狀況,我們相信我們完全有能力利用這些類型的機會。

  • And thirdly, with our expanded sales force, we now have an established commercial infrastructure and track record of successfully commercializing niche rare disease products, which makes us an attractive commercial partner. Industry peers have taken notice of our recent results, especially with carglumic acid success. And we have seen an uptick in inbound interest from companies looking for Eton to commercialize their rare disease products.

    第三,隨著我們擴大的銷售隊伍,我們現在擁有成熟的商業基礎設施和成功將利基罕見疾病產品商業化的記錄,這使我們成為有吸引力的商業合作夥伴。業界同行已經註意到我們最近的成果,特別是卡格魯酸的成功。我們發現,尋求伊頓公學將其罕見疾病產品商業化的公司對入境興趣有所上升。

  • During the second quarter, we were the stalking horse bidder in a bankruptcy auction for two commercial rare disease products. They were on-market products generating a significant amount of annual revenue. We were ultimately outbid in this. However, even though we did not acquire the assets, we had lined up $50 million in fully committed capital to support our bid.

    第二季度,我們成為兩種商業罕見疾病產品破產拍賣的潛馬競標者。它們是市場上的產品,每年產生大量收入。我們最終在這件事上被擊敗了。然而,儘管我們沒有收購這些資產,但我們已經投入了 5000 萬美元的全額承諾資本來支持我們的投標。

  • Given the extremely challenging environment for raising capital, I was proud of our ability to very quickly line up $50 million on attractive terms. Normally, this takes months; it took us a couple of weeks.

    鑑於籌集資金的環境極具挑戰性,我為我們能夠以有吸引力的條件迅速籌集到 5000 萬美元而感到自豪。通常,這需要幾個月的時間;我們花了幾個星期的時間。

  • I believe lenders were excited by our attractive near- and long-term financial outlook and our diversified portfolio. We believe we have a similar financial resources at our disposal today to pursue other large transactions involving commercial products.

    我相信貸款人對我們有吸引力的近期和長期財務前景以及多元化的投資組合感到興奮。我們相信,我們今天擁有類似的財務資源來進行涉及商業產品的其他大型交易。

  • Since we were the stalking horse bidder in that process, we did receive an $800,000 break-up fee. While we would have been much happier if we won the auction, the break-up fee further strengthens our financial position and will help us fund future acquisitions for us.

    由於我們是這個過程中的暗馬競標者,我們確實收到了 80 萬美元的分手費。雖然如果我們贏得拍賣,我們會更高興,但分手費進一步增強了我們的財務狀況,並將幫助我們為未來的收購提供資金。

  • Also this quarter, we monetized our remaining royalty interest in neurology oral liquid products we previously out-licensed to Azurity. In exchange for selling off our go-forward royalty interest, we received a $5.5 million payment in June. We believe we will be able to reinvest these proceeds into rare disease product opportunities that will yield much higher returns for the company.

    同樣在本季度,我們將之前授權給 Azurity 的神經科口服液產品的剩餘特許權權益貨幣化。作為出售我們的遠期特許權使用費權益的交換,我們在 6 月份收到了 550 萬美元的付款。我們相信,我們將能夠將這些收益再投資於罕見疾病產品機會,從而為公司帶來更高的回報。

  • This transaction fully closes out all of Eton's future income or liabilities related to those products. In total, during the life of those three products, we received more than $27.5 million in payments after investing approximately only $8 million into the portfolio.

    這項交易完全消除了伊頓公學與這些產品相關的所有未來收入或負債。總的來說,在這三種產品的生命週期中,我們僅向投資組合投資了約 800 萬美元,但收到了超過 2750 萬美元的付款。

  • With another record quarter of product sales, strong cash position of more than $21 million, and an attractive pipeline, we believe we are well positioned to deliver sustainable long-term growth. I believe we are now able to reach our goal of achieving 10 rare disease products on-market by the end of 2025.

    憑藉再創紀錄的季度產品銷售、超過 2100 萬美元的強勁現金狀況以及有吸引力的產品線,我們相信我們已做好充分準備,能夠實現可持續的長期增長。我相信我們現在能夠實現到 2025 年底將 10 種罕見病產品上市的目標。

  • I'm incredibly proud of our team for working so diligently to get us to where we are today and positioning us for a bright future going forward. It's an exciting time at Eton and I can't wait to update you on our progress throughout the rest of the year.

    我為我們的團隊感到無比自豪,他們如此努力工作,使我們達到了今天的水平,並為我們創造了光明的未來。這是伊頓公學令人興奮的時刻,我迫不及待地想向您介紹我們在今年剩餘時間裡取得的最新進展。

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

    接下來,我會將其交給我們的首席財務官詹姆斯來討論財務狀況。詹姆士?

  • James Gruber - CFO

    James Gruber - CFO

  • Thank you, Sean. Our second-quarter revenue was $12.0 million compared to $7.4 million in the second quarter of 2022, or a 63% increase, driven entirely by growth in product sales and royalties, specifically increased sales volume for our ALKINDI SPRINKLE and carglumic acid.

    謝謝你,肖恩。我們第二季度的收入為1200 萬美元,而2022 年第二季度的收入為740 萬美元,增長了63%,這完全是由產品銷售和特許權使用費的增長推動的,特別是我們的ALKINDI SPRINKLE 和卡魯酸的銷量增加。

  • Licensing revenue was $5.5 million in the second quarter of 2023 compared to $5.0 million in the prior year period. Total revenue grew $6.7 million or 126% compared to the first quarter of 2023, and product sales and royalty revenue grew by $1.2 million. We expect product sales to continue growing quarter over quarter throughout the rest of this year and beyond.

    2023 年第二季度的許可收入為 550 萬美元,而去年同期為 500 萬美元。與 2023 年第一季度相比,總收入增長 670 萬美元,即 126%,產品銷售和特許權使用費收入增長 120 萬美元。我們預計今年剩餘時間及以後的產品銷售將繼續逐季增長。

  • R&D expenses for the quarter were $1.1 million compared with $0.7 million in the prior year period due primarily to a $0.5 million fee paid upon the successful manufacturing of registration batches of ET-600, the innovative product candidate we acquired last quarter. We expect to see a slight increase in R&D spend in future quarters due to development activities related to both ET-400 and ET-600.

    本季度的研發費用為 110 萬美元,而上年同期為 70 萬美元,主要是由於我們上季度收購的創新候選產品 ET-600 註冊批次的成功生產而支付了 50 萬美元的費用。由於與 ET-400 和 ET-600 相關的開發活動,我們預計未來幾個季度的研發支出將略有增加。

  • General and administrative expenses for the quarter were $4.7 million compared with $5.3 million in the prior year period due primarily to decreased FDA and legal fees associated with products sold to Dr. Reddy's in June of 2022. We expect expenses to continue to remain consistent throughout the rest of the year and we still anticipate our full-year G&A expense to be approximately $20 million.

    本季度的一般和管理費用為470 萬美元,而上年同期為530 萬美元,這主要是由於與2022 年6 月銷售給Dr. Reddy's 的產品相關的FDA 費用和法律費用減少。我們預計整個季度的費用將繼續保持一致今年剩下的時間裡,我們仍然預計全年的一般管理費用約為 2000 萬美元。

  • Total company net income was $4.6 million for the quarter compared to a net loss of $1.6 million in the prior year period. Net income for basic and diluted share during the quarter was $0.18 compared to a net loss per basic and diluted share of $0.06 in the prior year period.

    該季度公司淨利潤總額為 460 萬美元,而去年同期淨虧損為 160 萬美元。本季度基本股和稀釋股淨利潤為 0.18 美元,而去年同期基本股和稀釋股淨虧損為 0.06 美元。

  • Eton finished the second quarter with $21.6 million of cash on hand and generated $7.1 million of operating cash during the quarter. We remain confident that our cash position is sufficient to allow us to execute our plan and continue pursuing bolt-on transactions and new product developments.

    伊頓公學第二季度末手頭現金為 2160 萬美元,本季度運營現金為 710 萬美元。我們仍然相信,我們的現金狀況足以讓我們執行我們的計劃並繼續進行補充交易和新產品開發。

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

    我們對第二季度業績的評論到此結束。這樣,我們會將其轉回給操作員進行問答。

  • Operator

    Operator

  • Thank you. We will now conduct a question-and-answer session. (Operator Instructions)

    謝謝。我們現在將進行問答環節。 (操作員說明)

  • Raghuram Selvaraju, H.C. Wainwright.

    拉古拉姆·塞爾瓦拉朱 (Raghuram Selvaraju),H.C.溫賴特。

  • Raghuram Selvaraju - Analyst

    Raghuram Selvaraju - Analyst

  • Hi, thanks very much for taking my questions. Just a few quick ones. Firstly, I was wondering if you could perhaps comment on your criteria and potential timeline for acquisition of new products, if you have some specific areas that you are going to be focusing on, if we should be thinking about these products as being directly complementary to or synergistic with the existing commercial products in your portfolio?

    您好,非常感謝您回答我的問題。就幾個快速的。首先,我想知道您是否可以評論一下您購買新產品的標準和潛在時間表,您是否有一些要關注的特定領域,我們是否應該將這些產品視為直接補充或者與您的產品組合中現有的商業產品產生協同作用?

  • Secondly, I wanted to make sure I fully understood situation with the dehydrated alcohol product and whether you feel that there is going to be an opportunity to prepare for marketing in a more thorough way or do activities or pre-launch that you wouldn't otherwise have been able to do given the new -- the extended timeline to potential market entry.

    其次,我想確保我完全了解無水酒精產品的情況,以及您是否認為有機會以更徹底的方式準備營銷或進行您不會做的活動或預發布鑑於新的潛在市場進入時間延長,我們已經能夠做到這一點。

  • And then lastly, with respect to the stock-based compensation, I was just wondering if you could point me to any potential trends we should be keeping an eye out for over the course of the remainder of this year. Thank you.

    最後,關於基於股票的薪酬,我只是想知道你是否可以向我指出我們在今年剩餘時間內應該關注的任何潛在趨勢。謝謝。

  • Sean Brynjelsen - CEO & Director

    Sean Brynjelsen - CEO & Director

  • Thanks, Ram. Sean here. So regarding M&A activity, I do anticipate closing a deal or two prior to the year, and we hope -- we would say that likely that these products would be a good fit with our existing sales organization and would be accretive to revenue.

    謝謝,拉姆。肖恩在這裡。因此,關於併購活動,我確實預計在今年之前完成一兩筆交易,我們希望 - 我們會說這些產品可能會非常適合我們現有的銷售組織,並且會增加收入。

  • Obviously, there's no guarantee of that, but we are in late-stage discussions. I'd say the environment is fantastic in terms of a deal on availability. And I'm not averse to closing a transaction outside of our core competency within endocrinology and metabolic genetics.

    顯然,這並不能保證,但我們正處於後期討論階段。我想說,就可用性而言,環境非常棒。我並不反對完成內分泌學和代謝遺傳學領域核心能力之外的交易。

  • But I think the product would have to justify the expenditure of additional SG&A resources. So that's something we're looking at and we'll see what happens.

    但我認為該產品必須證明額外的銷售、管理和行政資源支出是合理的。所以這就是我們正在關注的事情,我們會看看會發生什麼。

  • Maybe, David, you want to take the second question?

    大衛,也許你想回答第二個問題?

  • David Krempa - Chief Business Officer

    David Krempa - Chief Business Officer

  • In terms of the alcohol, no, Ram, dehydrated alcohol would be marketed by our partner. So we don't have any plans to do anything different based on the additional timeline.

    就酒精而言,不,拉姆,我們的合作夥伴將銷售無水酒精。因此,我們沒有任何計劃根據額外的時間表做任何不同的事情。

  • It's a product that, as you know, is already used in the market by almost every hospital. So it's not one that requires a lot of promotion from them. It's mostly going to be ordered through the GPOs and the wholesalers without much promotion.

    如您所知,該產品已在市場上被幾乎所有醫院使用。所以這並不需要他們進行大量的宣傳。主要是通過 GPO 和批發商訂購,沒有太多促銷。

  • And your third question, James will answer.

    你的第三個問題,詹姆斯會回答。

  • James Gruber - CFO

    James Gruber - CFO

  • Sure. Yeah. With the stock-based comp, Ram, second quarter was pretty representative. We don't expect anything unusual or one-time in that arena in the second half of 2023. So the most recent quarter would be a good run rate to use.

    當然。是的。對於基於股票的比較,拉姆,第二季度非常具有代表性。我們預計 2023 年下半年該領域不會出現任何異常或一次性情況。因此,最近一個季度的運行率將是一個很好的運行率。

  • Raghuram Selvaraju - Analyst

    Raghuram Selvaraju - Analyst

  • Okay. And then just very quickly, do you have any additional updates on the legal front with respect to cysteine hydrochloride?

    好的。然後很快,您對半胱氨酸鹽酸鹽的法律方面有任何其他更新嗎?

  • David Krempa - Chief Business Officer

    David Krempa - Chief Business Officer

  • No update at this time. We are expecting a decision sometime into early 2024, but there's no hard timeline that could get delayed. But our best guess is sometime in the first half of 2024.

    目前沒有更新。我們預計會在 2024 年初的某個時候做出決定,但沒有可能推遲的硬性時間表。但我們最好的猜測是 2024 年上半年的某個時間。

  • Raghuram Selvaraju - Analyst

    Raghuram Selvaraju - Analyst

  • Great. Thanks very much.

    偉大的。非常感謝。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • I will now pass it over back to David.

    我現在將其轉回給大衛。

  • David Krempa - Chief Business Officer

    David Krempa - Chief Business Officer

  • Thank you. We have a few questions that were e-mailed to us that we can go through and answer at this time. First one, is there any chance that the FDA may issue a priority review voucher to Eton for ET-600 if the product is approved?

    謝謝。我們有一些通過電子郵件發送給我們的問題,我們現在可以查看並回答。第一,如果ET-600獲得批准,FDA是否有可能向Eton頒發優先審評憑證?

  • No, we're not expecting any voucher for that product. Typically, the vouchers, among other things, have to be a new molecule. This one is going to be a 505(b)(2). So we're not expecting a voucher.

    不,我們不希望該產品有任何優惠券。通常,優惠券必須是一個新的分子。這將是 505(b)(2)。所以我們並不期待優惠券。

  • Second question is: when do you expect to give guidance for 2024 revenue? I will let James answer them.

    第二個問題是:預計什麼時候給出2024年營收指引?我會讓詹姆斯來回答他們。

  • James Gruber - CFO

    James Gruber - CFO

  • Sure. Historically, Eton does not provide a full-year guidance in advance. However, with ongoing M&A activity, if there was a transformational transaction in the second half of 2023, we would likely provide some guidance on how that would impact the portfolio going forward.

    當然。從歷史上看,伊頓公學不會提前提供全年指引。然而,隨著併購活動的持續進行,如果 2023 年下半年發生轉型交易,我們可能會提供一些指導,說明這將如何影響未來的投資組合。

  • David Krempa - Chief Business Officer

    David Krempa - Chief Business Officer

  • And the last question we have is: what are your commercial expectations for ET-400? And I'll let Sean answer that one.

    我們的最後一個問題是:您對 ET-400 的商業期望是什麼?我會讓肖恩回答這個問題。

  • Sean Brynjelsen - CEO & Director

    Sean Brynjelsen - CEO & Director

  • Thanks. So ET-400 really was a patient-and-doctor request. It was a product that is desperately needed by especially young patients, 2 and below. Sometimes they have trouble with the granularity of the sprinkles. And so they're forced to go to compounding pharmacies to obtain a liquid suspension of hydrocortisone that is not approved for sale. It has no demonstration of safety and efficacy. Also, Pfizer had a liquid version many years ago that had issues and got pulled from the market.

    謝謝。所以 ET-400 確實是患者和醫生的共同請求。這是一種特別是 2 歲及以下的年輕患者迫切需要的產品。有時他們對灑水的粒度有困難。因此,他們被迫去複方藥房購買未經批准銷售的氫化可的松液體懸浮液。它沒有證明安全性和有效性。此外,輝瑞公司多年前就有過液體版本,但因存在問題而被撤出市場。

  • Our product, our hydrocortisone oral solution is room-temperature stable. We expect a 24-month expiration date. And it's a product that we think is really going to drive sales of the franchise. We think there are approximately 10,000 patients, 18 and under, that can benefit from ALKINDI or ET-400. And I feel confident that we'll hit several thousand of those patients with the combination of these two products.

    我們的產品氫化可的鬆口服溶液在室溫下穩定。我們預計有效期為 24 個月。我們認為這是一款真正能夠推動特許經營銷售的產品。我們認為大約有 10,000 名 18 歲及以下患者可以從 ALKINDI 或 ET-400 中受益。我相信,我們將通過這兩種產品的組合來治療數千名患者。

  • David Krempa - Chief Business Officer

    David Krempa - Chief Business Officer

  • That concludes our questions. Thank you, everyone, for joining us today.

    我們的問題到此結束。謝謝大家今天加入我們。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for participating. You may now disconnect.

    今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。