Eton Pharmaceuticals Inc (ETON) 2024 Q2 法說會逐字稿

Good afternoon, and welcome to the Eton Pharmaceuticals second quarter 2024 financial results conference call. (Operator Instructions) Please be advised, this call is being recorded at the company's request.

下午好，歡迎參加伊頓製藥 2024 年第二季財務業績電話會議。（操作員說明）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 Eaton Pharmaceuticals. Please proceed.

這次，我想把它交給伊頓製藥公司首席商務官 David Krempa。請繼續。

Good afternoon, everyone, and welcome to Eaton's Second 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, eatonpharma.com.

大家下午好，歡迎參加伊頓 2024 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主題。新聞稿可在我們的網站 eatonpharma.com 上取得。

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. Investors can send their questions to investorrelations@etonpharma.com.

今天加入我們的電話會議的有我們的執行長 Sean Brynjelsen；和我們的財務長詹姆斯格魯伯。除了在今天的電話會議上回答即時問題外，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 this 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，本次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有重大差異。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執行長 Sean Brynjelsen。

Thank you, David. Good afternoon, everyone, and thank you for joining us today. We are pleased to be reporting yet another quarter of record product sales. Eaton began 2024 with high expectations across all areas of the business. And now that we've reached the midpoint of the year, I'm proud to say we're executing on all fronts. We've continued to rapidly grow sales of our existing commercial products while also delivering on the advancement of our pipeline products, most notably ET-400. And we were able to do all of this while generating positive cash flow from operations in the second quarter. I could not be happier with our corporate performance so far this year.

謝謝你，大衛。大家下午好，感謝您今天加入我們。我們很高興地報告又一個季度的產品銷售創紀錄。伊頓在 2024 年開始，對所有業務領域都抱有很高的期望。現在我們已經到了今年的中期，我很自豪地說我們正在各個方面執行。我們持續快速成長現有商業產品的銷售量，同時也持續改進我們的管道產品，尤其是 ET-400。我們能夠做到這一切，同時從第二季的營運中產生正現金流。我對今年迄今的公司業績感到非常滿意。

The second quarter was Eaton's 14 straight quarter of sequential product sales growth. We are very proud of this streak and based on our portfolio's long runway for growth, we expect the streak to continue for the foreseeable future. Product sales increased 40% year-over-year to $9.1 million in the quarter and grew 14% over the previous high in the preceding quarter. Absent any unannounced M&A transactions, we expect to reach positive GAAP net income by the end of this year. These impressive results were primarily due to continued strength from both of our lead products, ALKINDI SPRINKLE and Carglumic Acid.

第二季是伊頓產品銷售連續第 14 季實現成長。我們對這種連續成長感到非常自豪，並且基於我們投資組合的長期成長跑道，我們預計這種連續成長將在可預見的未來繼續下去。本季產品銷售額年增 40%，達到 910 萬美元，比上一季的高點成長 14%。如果沒有任何未宣布的併購交易，我們預計到今年年底將達到正的 GAAP 淨利。這些令人印象深刻的業績主要歸功於我們的主導產品 ALKINDI SPRINKLE 和 Carglumic Acid 的持續強勁表現。

ALKINDI SPRINKLE saw its growth accelerate in the second quarter as we have seen a strong uptick in the number of new patient referrals received this year. ALKINDI revenue increased an impressive 63% year-over-year. Given that ALKINDI is our highest margin product and one which we believe has the largest market opportunity, we are very pleased to see this acceleration of growth.

ALKINDI SPRINKLE 在第二季度成長加速，因為我們看到今年收到的新患者轉診數量大幅增加。ALKINDI 營收年增 63%，令人印象深刻。鑑於 ALKINDI 是我們利潤率最高的產品，也是我們認為擁有最大市場機會的產品，我們很高興看到這種加速成長。

Sales are benefiting from several key initiatives, including our team's strong presence at endocrinology medical conferences during the first half of the year, the initiation of our sampling program and the improved productivity of our internal sales force. We are now in the second year of having our full internal sales force in place, and we are seeing the results of our team strengthening relationships that they worked hard to develop over the last 18 months in their respective territories. Eaton now has more than 400 active patients on therapy, and we estimate that this only represents 10% of the target market. So we still have a long ways to go.

銷售受益於多項關鍵舉措，包括我們的團隊在今年上半年的內分泌醫學會議上的強勢表現、我們抽樣計劃的啟動以及我們內部銷售人員生產力的提高。現在是我們組建完整的內部銷售團隊的第二年，我們看到了我們的團隊在過去 18 個月裡在各自領域努力建立的關係的強化成果。伊頓目前有超過 400 名活躍患者正在接受治療，我們估計這僅佔目標市場的 10%。所以我們還有很長的路要走。

On the metabolic side of our portfolio, Carglumic Acid continues to shine. Once again, the product is exceeding our expectations, and we are happy with the performance. Carglumic posted record revenue in Q2 and we have already added additional new patients in July, so we expect the revenue growth to continue. Sticking with the metabolic portfolio, we were excited to announce the acquisition of PKU GOLIKE in March, and we have now fully relaunched the product with our commercial organization. Patients who suffer from phenylketonuria, also known as PKU, like the enzyme needed to break down phenylalanine and amino acid found in protein.

在我們產品組合的代謝方面，卡格魯酸繼續表現出色。該產品再次超出了我們的預期，我們對其性能感到滿意。Carglumic 在第二季的營收創歷史新高，我們在 7 月已經增加了更多的新患者，因此我們預計收入將繼續成長。堅持代謝產品組合，我們很高興在三月宣布收購北大高麗客，現在我們已經與我們的商業組織全面重新推出了該產品。患有苯酮尿症（也稱為 PKU）的患者喜歡分解蛋白質中苯丙胺酸和胺基酸所需的酵素。

A consumption of protein -- of regular protein can result in a buildup of this amino acid, which may result in neurological issues. To combat this, an estimated 8,000 PKU patients in the US rely on specialized protein medical formulas, such as PKU GOLIKE. PKU GOLIKE was a strong strategic fit for Eaton because the condition is managed by metabolic geneticists, the same health care professionals that we are actively engaged with in our other metabolic products.

蛋白質的消耗－普通蛋白質會導致這種胺基酸的積累，這可能會導致神經系統問題。為了解決這個問題，美國估計有 8,000 名 PKU 患者依賴專門的蛋白質藥物配方，例如 PKU GOLIKE。PKU GOLIKE 非常適合伊頓，因為這種疾病是由代謝遺傳學家管理的，他們也是我們在其他代謝產品中積極參與的醫療保健專業人員。

We also view GOLIKE as a best-in-class product because it offers a variety of formats, including a unique bar and is significantly better tasting than the competing products and has a delayed release technology designed to keep patients full for longer periods of time. In addition to these compelling benefits, the acquisition of GOLIKE offered meaningful financial upside. We paid less than 2x revenue for the asset, even though GOLIKE was and is still early in its launch with significant revenue left to capture.

我們也認為 GOLIKE 是同類最佳產品，因為它提供多種形式，包括獨特的棒狀產品，其味道明顯優於競爭產品，並且具有延遲釋放技術，旨在讓患者長時間保持飽腹感。除了這些引人注目的好處之外，收購 GOLIKE 還提供了有意義的財務優勢。我們為該資產支付了不到 2 倍收入的費用，儘管 GOLIKE 過去和現在仍處於推出初期，還有大量收入有待獲取。

In mid-April, our sales team relaunched GOLIKE at the genetic metabolic dietitians International Conference and received immediate strong interest. We've already seen an uptick in new patient referrals since our promotional activities have begun.

4月中旬，我們的銷售團隊在遺傳代謝營養師國際會議上重新推出了GOLIKE，立即引起了強烈興趣。自從我們的促銷活動開始以來，我們已經看到新患者轉診量增加。

And we continue to work towards our goal of achieving 10% market share of the estimated $100 million market for PKU medical foods in the US Eaton has also continued to add patients on Betaine and Nitisinone. Although the revenue impact for these two products is significantly lower than Carglumic Acid, they have further strengthened our relationship in the metabolic geneticists community, increasing the frequency of interactions with potential Carglumic Acid prescribers and now offering an additional opportunity to promote PKU GOLIKE.

我們繼續努力實現我們的目標，在美國 PKU 醫療食品市場中獲得 10% 的市場份額，該市場估計價值 1 億美元。儘管這兩種產品對收入的影響明顯低於卡格酸，但它們進一步加強了我們與代謝遺傳學家社區的關係，增加了與潛在卡格酸處方者互動的頻率，現在提供了推廣PKU GOLIKE的額外機會。

Turning to our development pipeline over the past several quarters, you've heard me discuss the importance of our pipeline candidate ET-400. Our proprietary patented formulation of hydrocortisone oral solution. This formulation is in high demand from patients, caregivers and physicians.

談到過去幾季我們的開發管道，您已經聽到我討論了我們管道候選產品 ET-400 的重要性。我們專有的氫化可的鬆口服溶液專利配方。配方深受患者、照護者和醫生的歡迎。

And if approved, would complement ALKINDI SPRINKLE and provide an alternative for the large contingent of patients, potentially several thousand who prefer a liquid product. Currently, these patients are either creating their homemade suspension by mixing crush tablets with water or using a compounded product that is not FDA approved.

如果獲得批准，將補充 ALKINDI SPRINKLE 並為大量患者（可能有數千名更喜歡液體產品的患者）提供替代方案。目前，這些患者要么通過將壓碎藥片與水混合來自製懸浮液，要么使用未經 FDA 批准的複合產品。

During the second quarter, we completed our NDA submission for ET-400 to the FDA. Last month, we received the exciting news that the NDA was accepted for review. We're thrilled to be one step closer to bringing this critical medication to patients in need.

第二季度，我們向 FDA 完成了 ET-400 的 NDA 提交。上個月，我們收到了令人興奮的消息，NDA 已被接受審查。我們很高興能夠向有需要的患者提供這種關鍵藥物又更近了一步。

The FDA has assigned our application of PDUFA target action date of February 28, 2025, and I have initiated launch preparation activities accordingly. We plan to begin production of commercial product in the fourth quarter of this year. We expect to be in a position to launch ET-400 quickly upon its anticipated approval in February. Once approved, we believe ET-400 will allow us to capture a greater percentage of the oral hydrocortisone market and together with ALKINDI SPRINKLE achieved combined peak sales of more than $50 million annually.

FDA 已指定我們申請 PDUFA 的目標行動日期為 2025 年 2 月 28 日，我已相應啟動準備活動。我們計劃在今年第四季開始生產商業產品。預計 ET-400 將於 2 月獲得批准，我們預計將能夠迅速推出該產品。一旦獲得批准，我們相信 ET-400 將使我們能夠佔領更大比例的口服氫化可的松市場，並與 ALKINDI SPRINKLE 一起實現每年超過 5000 萬美元的綜合峰值銷售額。

As you know, we are very excited about this product's potential. We believe growth of our existing portfolio, combined with the ET-400 launch that's eaten up for a major inflection point in 2025. We've also made steady progress with ET-600, our product candidate under development for the treatment of diabetes insipidus. This product has passed its pilot bioequivalency study, and we are on track to complete a pivotal study over the next several months. We expect to submit the NDA early in 2025 for potential approval 10 months later.

如您所知，我們對該產品的潛力感到非常興奮。我們相信我們現有產品組合的成長，加上 ET-400 的推出，將在 2025 年迎來一個重大轉折點。我們在 ET-600 方面也取得了穩定進展，ET-600 是我們正在開發的用於治療尿崩症的候選產品。該產品已通過其試點生物等效性研究，我們預計將在接下來的幾個月內完成一項關鍵研究。我們預計於 2025 年初提交 NDA，以便在 10 個月後獲得批准。

In addition to growth from our commercial products and near-term pipeline candidates, we continue to pursue opportunities to grow business development. We believe we are in a very attractive position from which to do this. We have a healthy balance sheet. We are generating cash, and our product sales are poised to continue growth for many years to come. As a result, we have the luxury of being able to remain patient and disciplined as we pursue new opportunities. While we certainly don't need to complete any transactions in order for the company to be successful, we do see opportunities to earn very attractive returns by putting money to work in commercial rare disease products that are a strong strategic fit.

除了我們的商業產品和近期候選產品的成長之外，我們還繼續尋求成長業務發展的機會。我們相信我們處於非常有吸引力的位置來做到這一點。我們擁有健康的資產負債表。我們正在創造現金，我們的產品銷售預計將在未來許多年繼續成長。因此，我們在尋求新機會時能夠保持耐心和紀律。雖然我們當然不需要完成任何交易才能使公司取得成功，但我們確實看到了透過將資金投入策略性很強的商業罕見疾病產品來獲得非常有吸引力的回報的機會。

We are actively engaged in discussions on multiple opportunities and remain optimistic about our ability to land another product before year-end. We remain focused on commercial assets that can immediately deliver revenue and earnings to the company. In addition to the excess cash on our balance sheet, we believe we have significant additional capital available to us should we need it. Given our current stock price relative to our near and long-term expectations for the business, our strong preference would be to utilize debt for any larger transactions.

我們正在積極參與多種機會的討論，並對我們在年底前推出另一種產品的能力保持樂觀。我們仍然專注於能夠立即為公司帶來收入和收益的商業資產。除了資產負債表上的多餘現金之外，我們相信，如果我們需要的話，我們還可以使用大量額外資本。考慮到我們目前的股價相對於我們對業務的近期和長期預期，我們強烈傾向於利用債務進行任何較大的交易。

As we wrap up the call, I hope my remarks have made it clear why I'm excited about Eaton's prospects over the coming quarters. We are rapidly nearing a critical inflection point, and I believe our future will be very bright as we execute on our 3-pillar growth strategy. First, grow our existing products. These products are firing on all cylinders, as you saw with our record product sales for the quarter and 40% year-over-year growth. We expect growth to continue for the foreseeable future.

在我們結束電話會議時，我希望我的演講已經清楚地表明了為什麼我對伊頓未來幾季的前景感到興奮。我們正在迅速接近一個關鍵的轉折點，我相信，隨著我們執行三大支柱成長策略，我們的未來將非常光明。首先，發展我們現有的產品。如您所見，我們本季的產品銷售量創紀錄且年增 40%，這些產品正全力以赴。我們預計在可預見的未來，成長將持續下去。

Secondly, our late-stage pipeline candidates are set up to produce significant additional long-term revenue growth, starting with the major launch of ET-400 in early 2025, followed closely by the anticipated approval of ET-600 less than a year afterwards. Thirdly, we remain optimistic about our prospects to acquire new products through business development, which could turbocharge our growth and provide a major boost to our profitability. With the combination of these 3 levers, I believe we have a great opportunity to achieve our goal of reaching $100 million in revenue in the coming years.

其次，我們的後期管道候選產品旨在產生顯著的額外長期收入成長，從 2025 年初 ET-400 的主要推出開始，緊隨其後不到一年的 ET-600 預期獲得批准。第三，我們對透過業務發展獲得新產品的前景保持樂觀，這可以推動我們的成長並大大提高我們的獲利能力。透過這三個槓桿的結合，我相信我們有很好的機會實現未來幾年收入達到 1 億美元的目標。

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財務長詹姆斯來討論財務狀況。詹姆斯？

Thank you, Sean. Our second quarter revenue was $9.1 million compared to $12.0 million in the second quarter of 2023. The prior year period included $5.5 million of onetime licensing revenue related to the divestment of our neurology product royalties. Net product sales and royalty revenues for the second quarter of 2024 increased 40% to $9.1 million compared to $6.5 million in the prior year period, which included $0.6 million of nonrecurring royalty revenue. The second quarter product sales increase was driven primarily by growth in ALKINDI SPRINKLE and Carglumic Acid.

謝謝你，肖恩。我們第二季的營收為 910 萬美元，而 2023 年第二季的營收為 1,200 萬美元。上一年期間包括與我們的神經學產品特許權撤資相關的 550 萬美元一次性許可收入。2024 年第二季的產品淨銷售額和特許權使用費收入成長 40%，達到 910 萬美元，而去年同期為 650 萬美元，其中包括 60 萬美元的非經常性特許權使用費收入。第二季產品銷售成長主要是由 ALKINDI SPRINKLE 和 Carglumic Acid 的成長所推動的。

Product sales also grew $1.1 million or 14% compared to the first quarter of 2024. And as Sean mentioned, we expect product sales to continue growing quarter-over-quarter throughout the rest of this year and beyond. R&D expenses for the quarter were $3.0 million compared with $1.1 million in the prior year, with the increase due to the payment of a $2.0 million onetime NDA submission fee for ET-400. Absent of any new business development transactions, we expect R&D expense to return to its recent historic levels in the second half of the year.

與 2024 年第一季相比，產品銷售額也成長了 110 萬美元，即 14%。正如肖恩所提到的，我們預計今年剩餘時間及以後的產品銷售將繼續逐季成長。本季的研發費用為 300 萬美元，而上年同期為 110 萬美元，增加的原因是支付了 200 萬美元的 ET-400 一次性 NDA 提交費。在沒有任何新業務開發交易的情況下，我們預計研發費用將在今年下半年恢復到最近的歷史水準。

General and administrative expenses for the quarter were $5.6 million compared with $4.7 million in the prior year period, due primarily to increased sales and marketing expenses related to the PKU GOLIKE commercial launch as well as onetime legal fees associated with ongoing M&A activities. Total company net loss was $2.9 million for the quarter, which includes the $2.0 million ET-400 filing fee compared to net income of $4.6 million in the prior year period, which included the $5.5 million royalty sale to Azurity. Net loss per basic and diluted share during the quarter was $0.11 compared to net income per basic and diluted share of $0.18 in the prior year period.

本季的一般和管理費用為 560 萬美元，而去年同期為 470 萬美元，主要是由於與北大 GOLIKE 商業發布相關的銷售和行銷費用以及與正在進行的併購活動相關的一次性法律費用增加。該季度公司淨虧損總額為 290 萬美元，其中包括 200 萬美元的 ET-400 申請費，而去年同期的淨利潤為 460 萬美元，其中包括向 Azurity 出售的 550 萬美元的特許權使用費。本季基本每股和稀釋每股淨虧損為 0.11 美元，而去年同期基本每股和稀釋每股淨收益為 0.18 美元。

Eaton finished the second quarter with $17.7 million of cash on hand and generated $1.3 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. This concludes our remarks on second quarter results. And with that, we'll turn it over to the operator for Q&A.

伊頓第二季末手頭現金為 1,770 萬美元，並在該季度產生了 130 萬美元的營運現金。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。我們對第二季業績的評論到此結束。然後，我們會將其交給操作員進行問答。

(Operator Instructions)

（操作員說明）

Chase Knickerbocker of Craig-Hallum.

克雷格-哈勒姆的蔡斯·尼克博克。

First, maybe on GOLIKE, maybe just talk to how the reception has been kind of relative to your expectations when you bought it now that you've relaunched it and interacted with a lot of your physicians?

首先，也許在 GOLIKE 上，也許只是談論與您購買它時的期望相比，現在您已經重新啟動了它並與許多醫生進行了互動？

Sure. Chase, this is David. We've got very good reception since we acquired the product. It was not promoted for a number of months before we acquired it. So the launch trajectory had lost a little bit of momentum, but we started promoting it in April and a number of conferences and have been meeting with physicians face-to-face, and they've been very excited to see the support behind the product again. And we've already seen an uptick in the number of referrals that we get off the product.

當然。蔡斯，這是大衛。自從我們獲得該產品以來，我們受到了很好的歡迎。在我們獲得它之前，它已經好幾個月沒有促銷了。因此，發布軌跡失去了一點動力，但我們從四月份開始推廣它，並召開了一些會議，並與醫生進行了面對面的會面，他們非常高興看到該產品背後的支持再次。我們已經看到從該產品獲得的推薦數量增加。

So we're still very excited about the product. We still hope to capture 10% of that $100 million market. It's just going to take us a little bit to get back on a strong growth trajectory, given that it wasn't promoted for a number of months before we took over.

所以我們仍然對該產品感到非常興奮。我們仍然希望佔領這個 1 億美元市場的 10%。考慮到在我們接手之前的幾個月裡它都沒有得到推廣，我們需要一點時間才能回到強勁的成長軌道。

Got it. Maybe on Carglumic next. It seems like every kind of quarter, and we're talking about kind of another couple of patients that we've added. Maybe just speak to discontinuations, any potential discontinuations? And then so are these -- basically asked another way, are we net adding patients and you expect to have a decent number of patients growing through the year on Carglumic?

知道了。也許接下來是卡格魯米克。似乎每個季度都有，我們正在談論我們添加的其他一些患者。也許只是談論停產，任何潛在的停產？那麼這些也是——基本上換一種方式問，我們是否淨增加患者，您預計全年服用卡格魯米克的患者數量會增長嗎？

Chase, it's Sean. Yes, we have been pleasantly surprised by Carglumic performance. We continue to add additional patients. We just added two more patients recently. And it looks like we're going to be adding more month-over-month. So I'm continuously pleased with the product. And once we think we sort of have reached our max, patients seem to like a room temperature version of Carglumic Acid better than the brand. And I wouldn't be surprised if that revenue continues to grow.

蔡斯，我是肖恩。是的，我們對卡格魯米克的表現感到驚喜。我們持續增加更多患者。我們最近剛增加了兩名患者。看起來我們將逐月增加更多。所以我對這個產品一直很滿意。一旦我們認為我們已經達到了最大值，患者似乎比品牌更喜歡室溫版本的卡格酸。如果收入持續成長，我不會感到驚訝。

And is it that difference things driving it? Or is there may be some additional patients out there that we maybe didn't think of before or just kind of talk to what's different versus expectations?

這就是驅動它的不同因素嗎？或者可能還有一些我們之前沒有想到的額外患者，或者只是討論與預期不同的情況？

Yes, that's -- certainly part of it is the ease of the product, the longer shelf life after opening in the room temperature improvement over the brand product. But probably more importantly is that many of the new patients go on our products. So we're getting a lot of younger patients. What we're seeing is that our detailing our services, our patient care, Eaton Cares Program has had a big impact. We find that the doctors enjoy working with the company and that it's -- we try to make it easy for them. And so that there aren't a lot of hurdles to writing prescriptions.

是的，那是——當然，其中一部分是產品的易用性，在室溫下打開後的保質期比品牌產品有所改進。但可能更重要的是，許多新患者都在使用我們的產品。所以我們有很多年輕的患者。我們看到的是，我們對服務、病患照護、伊頓關懷計畫的詳細說明產生了巨大的影響。我們發現醫生們喜歡與公司合作，我們努力讓他們感到輕鬆。這樣一來，開處方就不存在太多障礙。

Got it. And maybe, James, on gross margins, I appreciate the commentary on kind of the strength with ALKINDI in the quarter. Gross margins were a little bit down sequentially. Can you just speak to kind of the drivers there? And then on cash flow positive in the quarter. Can you speak to kind of the working capital benefit that you had? And then how you kind of see that playing out in the back half of the year from a cash flow from operations perspective and kind of EBITDA?

知道了。詹姆斯，也許就毛利率而言，我很欣賞對本季 ALKINDI 實力的評論。毛利率較上季略有下降。你能和那裡的司機談談嗎？然後是本季的正現金流。您能談談您所獲得的營運資金效益嗎？那麼，從營運角度和 EBITDA 的角度來看，您如何看待下半年的現金流狀況？

Sure. Margin -- gross margin profile, a real slight decrease in the second quarter. I don't think it's anything more than product mix, just given the very different profiles that ALKINDI and Carglumic Acid have. We do expect at least consistent, if not slightly improved profile as we move forward as ALKINDI makes up a larger percentage of overall revenue.

當然。利潤率－毛利率概況，第二季實際略有下降。我認為這只不過是產品組合的問題，只是考慮到 ALKINDI 和 Carglumic Acid 具有非常不同的特性。我們確實預計，隨著 ALKINDI 在總收入中所佔比例的提高，我們的形象即使不是略有改善，至少也能保持一致。

From a working capital standpoint, absent that $2 million filing fee for ET-400. We turned cash flow positive from an operating standpoint in the second half of last year, definitely expect that to continue. Even amidst timing changes with some sales rebates and discount things like that. We should firmly be in positive operating cash flow for the rest of 2024 and moving toward GAAP income profitability as well.

從營運資金的角度來看，如果沒有 ET-400 的 200 萬美元申請費。從去年下半年的營運角度來看，我們的現金流轉為正值，肯定預計這種情況將持續下去。即使時間發生變化，也會有一些銷售回扣和折扣之類的事情。在 2024 年剩餘時間內，我們應該堅定地保持正營運現金流，並朝著 GAAP 收入獲利能力邁進。

Got it. And then maybe just a little bit of color on the ET-600 trial. Is it a pretty kind of straightforward pivotal PK? Anything you could call out specifically around the trial that makes it a little bit more complex? Or is it fairly straightforward from a lot of trials that you've ran in the past?

知道了。然後也許只是在 ET-600 試驗中添加一點顏色。這是相當直接的關鍵PK嗎？您可以特別指出有關試驗的任何內容，使其變得更加複雜嗎？或者從您過去進行的大量試驗來看，這是否相當簡單？

Chase, this is Sean. So the trial is a repeat of our pilot study, which passed with flying colors. I don't expect any difference from the pilot study to the pivotal study. The main difference in the design is the number of patients so that if you run a pilot and you run a fair number of patients, which we did. We don't expect that to be statistically different on the pivotal study because it was spot on in terms of the results.

蔡斯，這是肖恩。因此，這次試驗是我們試點研究的重複，該研究出色地通過了。我預計試點研究與關鍵研究不會有任何差異。設計的主要區別在於患者的數量，因此如果您進行試點並且您會運行相當數量的患者，就像我們所做的那樣。我們預計關鍵研究在統計上不會有差異，因為它的結果是正確的。

I think the -- that may be the gating item because in terms of filing it, but we expect that to be filed in the first quarter of 2025. And it's an exciting product. It's a product that was request from doctors, and we did some market research with patients as well. I think it will be very successful, and it will be a great launch for us in 2026.

我認為，這可能是門控項目，因為就提交而言，但我們預計將在 2025 年第一季提交。這是一個令人興奮的產品。這是醫生要求的產品，我們也對患者做了一些市場調查。我認為它會非常成功，對於我們 2026 年來說將是一次偉大的發布。

Got it. And as we kind of think about commercial preparations before potentially ET-400 launch, have you given any thought to any additional resources in the sales force, any additional heads there? And then how soon after a potential approval at the end of February, would you expect to launch the drug?

知道了。當我們考慮在可能推出 ET-400 之前進行商業準備時，您是否考慮過銷售團隊中的任何額外資源，以及那裡的任何額外負責人？那麼，在二月底可能獲得批准後，您預計多久會推出該藥物？

So we are currently happy with the size of our sales force. We have 12 reps. We are open to adding additional reps for the ET-400 launch. I don't know that it will be necessary. That's something that we'll decide. If it is necessary, it would be kind of in the two to four range. But at the moment, we have pretty good coverage in pediatric endocrinology. So the launch itself is really should happen shortly after approval.

因此，我們目前對銷售團隊的規模感到滿意。我們有 12 位代表。我們願意為 ET-400 的發布增加更多代表。我不知道這是否有必要。這是我們將決定的事情。如果有必要的話，應該是在兩到四個範圍內。但目前，我們在兒科內分泌方面有相當好的覆蓋範圍。因此，發布本身確實應該在獲得批准後不久進行。

So let's say we get approval on February 28. We will already have batches produced. We are producing commercial batches this year. They will be tested and released and ready. The only thing that would delay us from launching on February 28 is the labeling of the product. Normally, the FDA provides the labeling as the last step, and you typically need 3 to 4 weeks to print the new labeling and then package the product. So I would expect the launch to happen. Let's just say, April to play it on the safe side, it could potentially be March, but we'll say April.

假設我們在 2 月 28 日獲得批准。我們已經批量生產了。我們今年正在生產商業批次。它們將經過測試、發布並準備就緒。唯一會推遲我們 2 月 28 日上市的事情是產品的標籤。通常，FDA 會在最後一步提供標籤，您通常需要 3 到 4 週的時間來列印新標籤，然後包裝產品。所以我預計發射會發生。我們只是說，四月，為了安全起見，可能是三月，但我們會說四月。

Got it. And then just on BD, Sean, maybe speak to kind of the materiality of some of these deals we're pursuing and kind of how you're thinking about a potential fairly large transformative transaction for the company potentially by the end of the year. Just kind of some general more in-depth thoughts there.

知道了。然後就 BD 而言，肖恩，也許可以談談我們正在尋求的一些交易的重要性，以及您如何考慮到今年年底為公司可能進行的一項相當大的變革性交易。只是一些一般性的、更深入的想法。

And then just last for James. Speak to kind of SG&A cadence through the back half of the year here, James, kind of some interesting seasonality last year, kind of speak to how we should be modeling that in the back half?

最後是詹姆斯。詹姆斯，談談下半年的 SG&A 節奏，去年有一些有趣的季節性，談談我們應該如何在下半年建模？

So on the BD side, we are pursuing deals where for late-stage products, ideally commercial products, we do have those in progress for anything that would give us $10 million or more in additional revenue literally right out of the gate. So the size of the deal could be in the $20 million, $30 million range. We can do obviously some smaller deals, but our focus really is on $10 million and above at this point as we've been growing our revenue, our need to do smaller transactions has lessened. And it's really about the pivotal deals that are more meaningful. It doesn't really take a lot more work to do a larger deal versus a smaller deal. So that's where our focus is.

因此，在 BD 方面，我們正在尋求後期產品（最好是商業產品）的交易，我們確實正在進行那些可以立即為我們帶來 1000 萬美元或更多額外收入的交易。因此，交易規模可能在 2,000 萬至 3,000 萬美元之間。顯然，我們可以進行一些較小的交易，但此時我們的重點確實是 1000 萬美元及以上，因為我們的收入一直在增長，我們進行較小交易的需求已經減少。這實際上是更有意義的關鍵交易。與較小的交易相比，完成較大的交易實際上並不需要更多的工作。這就是我們的重點。

We are expecting to add one to two commercial products before the end of the year. And we're not that far to the end of the year, believe it or not. So I think that says a lot about perhaps where we are in our discussions.

我們預計在今年年底之前添加一到兩個商業產品。不管你信不信，距離今年底已經不遠了。所以我認為這或許說明了我們討論的進展。

And then Chase, from an SG&A standpoint, Q2 did have a handful of onetime items namely some legal consulting expenses related to ongoing M&A activity. As far as second half of the year, we would expect it to fall back to more like Q1 levels. Year-over-year, to your point, an uptick from 2023, the one big driver there is just with the commercial launch of GOLIKE, Eaton's commercial launch, there's a decent amount of commercial resource in this initial year. So that's really the one kind of year-over-year item. But it's not going to significantly change that run rate. So I would look more like Q1 for the rest of the year.

然後，從 SG&A 的角度來看，大通銀行確實有一些一次性項目，即與正在進行的併購活動相關的一些法律諮詢費用。就今年下半年而言，我們預計將回落至第一季的水平。就你的觀點而言，同比 2023 年有所上升，其中一個主要推動因素是 GOLIKE 的商業推出，伊頓的商業推出，第一年有相當多的商業資源。所以這確實是一種逐年的項目。但這不會顯著改變運行率。所以今年剩下的時間我看起來更像是第一季。

Got it. Congrats on the progress, guys.

知道了。恭喜你們取得了進步。

I am showing no further questions. Thank you for your participation in today's call. This does conclude the program. You may now disconnect.

我沒有提出任何進一步的問題。感謝您參加今天的電話會議。這確實結束了該程式。您現在可以斷開連線。