Iterum Therapeutics PLC (ITRM) 2025 Q1 法說會逐字稿

Hello, everyone, and thank you for joining the Iterum Therapeutics plc first-quarter 2025 earnings and business update call. My name is Lucy, and I will be coordinating your call today. (Operator Instructions)

大家好，感謝您參加 Iterum Therapeutics plc 2025 年第一季財報和業務更新電話會議。我叫露西，今天我要負責協調您的通話。（操作員指示）

I will now hand over to your host, Louise Barrett, SVP of Legal Affairs, to begin. Please go ahead.

現在我會把主持人、法律事務資深副總裁 Louise Barrett 交給她開始。請繼續。

Thank you, Lucy. Good morning, and welcome to Iterum Therapeutics plc first-quarter 2025 earnings and business update call. Our press release for our first quarter results was issued earlier this morning can be filed on our website. We are joined this morning by our Chief Executive Officer, Corey Fishman; and our Chief Financial Officer, Judy Matthews. Corey will provide some opening remarks.

謝謝你，露西。早安，歡迎參加 Iterum Therapeutics plc 2025 年第一季財報和業務更新電話會議。我們第一季業績的新聞稿已於今天早上發布，可在我們的網站上查閱。今天上午，我們的執行長 Corey Fishman 和財務長 Judy Matthews 也來到了我們這裡。科里將致開幕詞。

Judy will provide details on our financial results, and then we'll open the lines for Q&A. Before we begin, I'd like to remind you that some of the information presented on this conference call will contain forward-looking statements concerning our plans, strategies and prospects for our business, including the development of therapeutic and market potential of -- is sufficiently our cash resources to further operating expenses into 2026.

朱迪將提供有關我們財務結果的詳細信息，然後我們將開放問答環節。在我們開始之前，我想提醒您，本次電話會議中提供的一些資訊將包含有關我們業務計劃、策略和前景的前瞻性陳述，包括治療和市場潛力的發展——是否足以讓我們的現金資源進一步支付 2026 年的營運費用。

Our strategic process to sell license or otherwise dispose it to see panel, our ability to complete precommercialization activities for ORLYNVAH and prepare for a potential launch of ORLYNVAH by the fourth quarter of 2025 and the protection provided by our patents. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside our control, including risks and uncertainties concerning the outcome, impact effects and results of our evaluation of strategic alternatives, including the terms, timing, structure -- benefits and costs of any strategic alternatives; our ability to complete a strategic alternative transaction, our ability to successfully prepare and intimate commercialization plans for our ORLYNVAH with the commercial partner or directly.

我們出售許可證或以其他方式處置許可證以查看小組的戰略流程、我們完成 ORLYNVAH 的商業化前活動的能力以及為 2025 年第四季度之前推出 ORLYNVAH 做準備以及我們的專利提供的保護。由於我們無法控制的各種因素，實際結果可能與這些前瞻性陳述所示的結果存在重大差異，包括與戰略替代方案的評估結果、影響效果和結果有關的風險和不確定性，包括任何戰略替代方案的條款、時間、結構——收益和成本；我們完成戰略替代交易的能力，我們與商業夥伴或直接為我們的 ORLYNVAH 成功準備和製定商業化計劃的能力。

The design and time and well potential launch plans. The market opportunity for and potential market acceptance of ORLYNVAH our ability to continue the going concern, the accuracy of our expectations regarding how far in the future our cash on hand will fund our ongoing operations and other factors discussed under the caption risk factors in our report on Form 10-Q filed with the SEC this morning. In addition, any forward-looking statements represent a review as of the date of the role, which should not be relied upon as representing our views as of any subsequent date.

設計、時間和潛力巨大的發布計劃。ORLYNVAH 的市場機會和潛在市場接受度、我們繼續經營的能力、我們對於未來現金將如何支持我們持續運營的預期準確性，以及我們今天上午向美國證券交易委員會提交的 10-Q 表報告中“風險因素”標題下討論的其他因素。此外，任何前瞻性陳述均代表截至該職位發布之日的評論，不應被視為代表我們在任何後續日期的觀點。

We specifically disclaim any obligation to update such statements. We will also be referencing non-GAAP financial measures during the call. We've provided reconciliations of GAAP reported to non-GAAP adjusted information in the press release issued this morning.

我們明確否認有更新此類聲明的義務。我們也會在電話會議中參考非公認會計準則財務指標。我們在今天早上發布的新聞稿中提供了 GAAP 報告與非 GAAP 調整資訊的對帳。

With that, I'll say -- now I'll turn it over to you, Corey, for your opening remarks.

就此，我想說──現在我將把時間交給你，科里，請你致開場白。

Thanks, Louis. Welcome, and thanks for joining us today. I'd like to begin by providing some comments on our company priorities and associated activities. Our outreach to potential business development partners has yet to result in a transaction that the Board views is acceptable being in the best interest of our stakeholders. Business development remains a potential opportunity for us at any point.

謝謝，路易斯。歡迎您，感謝您今天加入我們。首先，我想就我們公司的優先事項和相關活動發表一些評論。我們與潛在業務發展夥伴的接觸尚未達成董事會認為可接受且符合我們利害關係人最佳利益的交易。無論何時，業務發展對我們來說都是一個潛在的機會。

And while we continue to pursue a strategic transaction, we remain open and excited to engage in discussions as they arise. . Having said that, we believe there is urgency to bring ORLYNVAH to the U.S. market to serve patients suffering with uncomplicated urinary tract infections who have limited or no other oral alternative treatment options. And as such, we have been preparing for the potential commercialization of ORLYNVAH over the last several months.

在我們繼續尋求策略交易的同時，我們仍保持開放態度並樂於參與任何出現的討論。。話雖如此，我們認為迫切需要將 ORLYNVAH 引入美國市場，為那些沒有或僅有有限其他口服替代治療選擇的單純性泌尿道感染患者提供服務。因此，過去幾個月我們一直在為 ORLYNVAH 的潛在商業化做準備。

As we have noted before, -- the U.S. market has been played by a lack of innovation in this therapy area over the last 25 years and antibiotic resistance to existing generic oral treatment options is eroding the efficacy of current therapies.

正如我們先前所指出的，過去 25 年來，美國市場一直缺乏該治療領域的創新，而對現有通用口服治療方案的抗生素抗藥性正在削弱目前治療的療效。

Additionally, almost all of the existing oral treatments have some safety challenges that again leaves physicians looking for efficacious and safe alternative treatments. Given this background and with the safety and efficacy of ORLYNVAH for the treatment of uncomplicated urinary tract infections, in adult women with designated microorganisms, we believe there is an excellent opportunity in this extensive market, which has been hugely neglected for nearly 3 decades. Let's take a moment now and talk about the uncomplicated urinary tract infection market in the U.S.

此外，幾乎所有現有的口腔治療方法都存在一些安全問題，這使得醫生必須尋找有效且安全的替代治療方法。鑑於這一背景以及 ORLYNVAH 在治療患有指定微生物的成年女性無併發症泌尿道感染方面的安全性和有效性，我們相信，這個廣闊的市場存在著絕佳的機會，而近 30 年來，該市場一直被嚴重忽視。現在讓我們花點時間討論一下美國的簡單泌尿道感染市場。

It is quite large and based on our research, generates approximately 40 million prescriptions annually in the U.S. And of those, approximately 2/3 or about 26 million prescriptions are written for at-risk patients. At risk patients are defined as women who are elderly, have comorbidities like diabetes, heart failure, kidney failure or cancer or women with a history of recurrent infections. We believe these at-risk patients represent ORLYNVAH addressable market as they likely are the patients with limited or no other oral treatment options available and are the patients most in need of new therapies.

這個規模相當大，根據我們的研究，美國每年產生約 4,000 萬張處方，其中約 2/3 或約 2,600 萬張處方是為高風險患者開立的。高風險患者是指老年女性、患有糖尿病、心臟衰竭、腎衰竭或癌症等合併症的女性或有反覆感染病史的女性。我們相信這些高風險患者代表了 ORLYNVAH 的潛在市場，因為他們可能是可用的口服治療選擇有限或沒有其他口服治療選擇的患者，也是最需要新療法的患者。

To put this addressable market size in a practical perspective, if the company were to capture a 1% share of the addressable market at peak, say, the fifth or sixth year after launch, and using current branded oral antibiotic pricing, resulting net sales would be over $250 million in that year. With regard to new competition in the marketplace, there was a product approved in April of 2024 that has yet to launch. Additionally, in the first quarter of this year, GlaxoSmithKline received approval for a product, in the uncomplicated urinary tract infection space and their current guidance is that they will launch in the second half of this year.

從實際角度來看，如果該公司在產品上市後的第五年或第六年等高峰期佔據可尋址市場的 1% 份額，並使用當前品牌口服抗生素的定價，那麼當年的淨銷售額將超過 2.5 億美元。關於市場上的新競爭，有一款產品已於 2024 年 4 月獲批，但尚未上市。此外，今年第一季度，葛蘭素史克獲得了用於治療簡單尿路感染的產品的批准，目前的指導價格是該產品將於今年下半年上市。

Clearly, this increases the urgency for us to get ORLYNVAH to market as quickly and efficiently as possible. I want to spend a minute and talk about the potential commercialization of ORLYNVAH. We have been working with Everson an end-to-end commercialization firm to prepare for a potential launch. As we build out our commercial launch plan, we have invested in pre-commercialization activities, including market research with physicians and payers, building the key promotional messaging for ORLYNVAH determining the optimal trade, distribution and patient services strategies, developing discussion materials for payers, beginning to compile a medical information database, and determining potential territory alignment for sales resources.

顯然，這增加了我們盡快、盡可能有效率地將 ORLYNVAH 推向市場的迫切性。我想花一點時間談談 ORLYNVAH 的潛在商業化。我們一直在與端到端商業化公司 Everson 合作，為潛在的發布做準備。在製定商業發布計劃時，我們投資了商業化前的活動，包括與醫生和付款人進行市場調查、為 ORLYNVAH 構建關鍵促銷信息、確定最佳貿易、分銷和患者服務策略、為付款人開發討論材料、開始編制醫療信息數據庫，並確定銷售資源的潛在區域分佈。

We believe that all the work done so far indicates ORLYNVAH as an important alternative for patients with limited or no other oral treatment options. In a commercialization scenario, we would expect to execute our launch in phases. Our first phase would be to put commercial resources in a limited number of territories based on 3 key criteria: number one, the rate of antibiotic resistance in that territory. Number two, the number of physicians in a territory who wrote a large amount of prescriptions in the uncomplicated urinary tract infection field. And number three, the managed care access in a designated territory.

我們相信，迄今為止所做的所有工作都表明 ORLYNVAH 是其他口腔治療選擇有限或沒有其他口腔治療選擇的患者的重要替代方案。在商業化場景中，我們希望分階段進行發布。我們的第一階段將根據三個關鍵標準將商業資源投入到有限數量的地區：第一，該地區的抗生素抗藥性。第二，一個地區在簡單泌尿道感染領域開出大量處方的醫生數量。第三，在指定區域內管理醫療服務。

Post launch, assuming we see solid results in these initial territories, we expect the next phase of the plan would be to either expand the number of territories we are promoting in, still using the same 3 criteria to determine optimal geographies or to remain in the existing territories or cover more physicians in those territories with additional resources.

推出後，假設我們在這些初始地區看到了堅實的成果，我們預計計劃的下一階段將是擴大我們推廣的地區數量，仍然使用相同的 3 個標準來確定最佳地理位置，或者保留在現有地區或使用額外資源覆蓋這些地區的更多醫生。

Of course, any near-term expansion would be subject to successfully raising additional capital. We expect that in a commercialization scenario, we will be able to launch ORLYNVAH in the U.S. market by the fourth quarter. There are a couple of other topics I'd like to cover today as well. As some of you may know, in January of this year, we repaid the outstanding principal and interest due under our exchangeable notes.

當然，任何短期擴張都必須成功籌集額外資金。我們預計，在商業化情況下，我們將能夠在第四季將 ORLYNVAH 推向美國市場。今天我還想討論其他幾個話題。你們中的一些人可能知道，今年 1 月，我們償還了可交換票據到期未償還的本金和利息。

This repayment eliminated a large amount of debt that has been on the company's books for a number of years. Lastly, we have extended our cash runway into 2026, which includes the potential launch of ORLYNVAH by the fourth quarter.

此次還款消除了公司多年來累積的大量債務。最後，我們將現金流量延長至 2026 年，其中包括可能在第四季度推出 ORLYNVAH。

In summary, as we look forward, we are very excited about the potential commercialization of ORLYNVAH in the U.S. The market dynamics remain favorable. Our planning work is going very well. No new products have launched in this space to date, and we have a very long runway to capture value with our patent protection going into 2039.

總之，展望未來，我們對 ORLYNVAH 在美國商業化的潛在前景感到非常興奮。市場動態仍然良好。我們的規劃工作進展非常順利。到目前為止，該領域還沒有推出任何新產品，而且我們的專利保護期將持續到 2039 年，因此我們還有很長的路要走才能實現價值。

I'll now turn the call over to Judy Matthews, our Chief Financial Officer, for a financial update.

現在我將把電話轉給我們的財務長朱迪·馬修斯 (Judy Matthews)，以了解財務最新情況。

Thanks, Corey. Total operating expenses were $3.7 million in the first quarter of 2025 compared to $6.2 million in the first quarter of 2024. Operating expenses include cost of sales, which is primarily the amortization of an intangible asset, research and development expenses and general and administrative expenses. R&D costs were approximately $600,000 in the first quarter compared to $4 million for the same period in 2024. The primary driver of the decrease in R&D expense for the first quarter was the decrease in costs associated with the ReAssure trial.

謝謝，科里。2025 年第一季的總營運費用為 370 萬美元，而 2024 年第一季的總營運費用為 620 萬美元。營業費用包括銷售成本（主要是無形資產攤提）、研發費用、一般及管理費用。第一季的研發成本約為 60 萬美元，而 2024 年同期的研發成本為 400 萬美元。第一季研發費用下降的主要原因是與 ReAssure 試驗相關的成本下降。

G&A costs were $2.8 million for the first quarter compared to G&A costs of $2.2 million for the same period in 2024. The primary driver of the increase in G&A expense for the first quarter was pre-commercialization activities. . Our net loss on a U.S. GAAP basis was $4.9 million for the first quarter of 2025 compared to a net loss of $7.1 million for the first quarter of 2024.

第一季的 G&A 成本為 280 萬美元，而 2024 年同期的 G&A 成本為 220 萬美元。第一季一般及行政費用增加的主要驅動因素是商業化前活動。。根據美國 GAAP 計算，2025 年第一季我們的淨虧損為 490 萬美元，而 2024 年第一季的淨虧損為 710 萬美元。

On a non-GAAP basis, which excludes certain noncash adjustments, our net loss of $3.3 million in the first quarter of 2025 compared to our non-GAAP net loss of $5.8 million in the first quarter of 2024. The $2.5 million decrease in our non-GAAP net loss for the first quarter was primarily a result of lower R&D expenses related to our ReAssure trial.

以非公認會計準則計算（不包括某些非現金調整），我們 2025 年第一季的淨虧損為 330 萬美元，而 2024 年第一季的非公認會計準則淨虧損為 580 萬美元。我們第一季非公認會計準則淨虧損減少 250 萬美元，主要是因為與 ReAssure 試驗相關的研發費用降低。

At the end of March, we had cash and cash equivalents of $12.7 million. Based on our current operating plan, which includes our currently planned pre-commercialization spend and potential commercial launch of ORLYNVAH by the fourth quarter of 2025, we expect that our cash and cash equivalents, together with $1 million of net proceeds raised under our aftermarket offering program from April 1 through April 22, 2025 and net proceeds of $4.2 million from the registered direct offering that closed April 30, 2025, we will be sufficient to fund our operations into 2026. On January 31, 2025, we repaid the outstanding principal and interest due under the exchangeable notes in accordance with their terms. As of May 12, 2025, we had approximately 40 million ordinary shares outstanding.

截至三月底，我們的現金和現金等價物為1,270萬美元。根據我們目前的營運計劃，其中包括我們目前計劃的商業化前支出和 2025 年第四季度前 ORLYNVAH 的潛在商業發布，我們預計我們的現金和現金等價物，加上 2025 年 4 月 1 日至 4 月 22 日期間根據售後市場發行計劃籌集的 100 萬美元萬美元淨收益，將足以資助我們到 2026 年的營運。2025年1月31日，我們根據可交換票據的條款償還了到期未償還的本金及利息。截至 2025 年 5 月 12 日，我們已發行約 4,000 萬股普通股。

Now we will open the line for questions.

現在我們將開放提問熱線。

(Operator Instructions) Matthew Keller, H.C. Wainwright.

（操作員指示）Matthew Keller，H.C. Wainwright。

Just 2 quick ones from us. The first, I was wondering if you could possibly speak a little bit more to the maturity of these conversations you're having with potential commercial partners. And then secondly, do you foresee any, if any, really outstanding rate limiting steps ahead of launch later this year.

我們只想簡單說兩句話。首先，我想知道您是否可以再多談談您與潛在商業夥伴進行的對話的成熟度。其次，您是否預見到在今年稍後推出之前會採取任何真正出色的限速措施（如果有的話）。

Matt, this is Corey. Thanks for the question. Can you just repeat the second one? I'm sorry.

馬特，這是科里。謝謝你的提問。你能重複第二個嗎？對不起。

No problem. Just if you foresee -- you mentioned the pre-commercialization activities. Is there any other outstanding rate-limiting steps that you might foresee ahead of ORLYNVAH's launch later this year? Does that make sense?

沒問題。正如您預見的——您提到了商業化前的活動。在今年稍後 ORLYNVAH 推出之前，您是否預見到還有其他未解決的限制利率措施？這樣有道理嗎？

Let's tackle them in the -- there's really not a lot of color we can add on any commercial partner discussions I'm assuming that sort of the BD side of it, we do view EVERSANA as our commercial partner, but I'm assuming that's not really what you were asking. I think we've had a number of big discussions. I think there's a host of rationales in people's mind that's too wide right now may not be the right time from their perspective to do any kind of partnership with us. But it's important to note, as I said, the business development is a constant in the biotech world and certainly for us as well.

讓我們來解決它們——在任何商業合作夥伴討論中我們真的沒有太多可以添加的內容，我認為在 BD 方面，我們確實將 EVERSANA 視為我們的商業合作夥伴，但我認為這並不是你真正想問的。我想我們已經進行過多次重要討論。我認為人們心中有很多理由，從他們的角度來看，現在可能不是與我們建立任何形式合作關係的最佳時機。但值得注意的是，正如我所說，業務發展在生技領域是持續不斷的，對我們來說當然也是如此。

There's never a long time for that conversation. So we absolutely remain open to it. We'd be happy to have those conversations with the specific parties if and when they arise and we will certainly do that. Having said that, we really do feel there's an urgency here. We've been approved for 6 months.

這樣的談話從來不會持續很久。因此我們對此絕對持開放態度。如果發生這種情況，我們很樂意與具體當事人進行對話，我們一定會這樣做。話雖如此，我們確實感到情況緊迫。我們已經獲得批准6個月了。

The market continues to be attractive, and we really think that ORLYNVAH can play a very important role in treating these at-risk patients. And so we really want to get this product into the hands of patients and physicians, and that's really our goal. And that leads into your second question, which are there any rate-limiting steps kind of remaining in order to be launching the drug by the fourth. And I'm happy to tell you that I don't see any big hurdles. There's a ton of work to do.

市場持續具有吸引力，我們確實認為 ORLYNVAH 可以在治療這些高風險患者方面發揮非常重要的作用。因此，我們確實希望將該產品送到患者和醫生手中，這才是我們的真正目標。這就引出了你的第二個問題，為了在第四季推出這種藥物，還有哪些限速措施需要採取？我很高興地告訴你們，我沒有看到任何大的障礙。有大量的工作要做。

But with regard to real impediment, there are no hurdles out there that would stop us from staying on that time line. The good news is we've come -- sorry we've made product and we have product available. So it's not like we have manufacturing time lines to deal with right now. And so I think we're in pretty good shape to actually hit that time line of getting commercial by the fourth quarter.

但就真正的障礙而言，沒有任何障礙能夠阻止我們堅持這一時間表。好消息是我們已經來了——抱歉，我們已經生產了產品，並且有可用的產品。所以我們現在不需要處理製造時間表。因此，我認為我們目前的狀態非常好，可以在第四季實現商業化。

Yes. No, it totally makes sense. And again, congrats on the quarter.

是的。不，這完全有道理。再次恭喜本季取得的成績。

We have no further questions, so I will hand back to Corey Fishman's, CEO, for closing remarks.

我們沒有其他問題，因此我將把發言權交還給執行長 Corey Fishman 作最後發言。

Thanks, Lucy. We appreciate you joining us today. We're very excited about the potential launch of ORLYNVAH by the fourth quarter of this year. we believe there really is a significant need for ORLYNVAH in the uncomplicated urinary tract infection market for those at-risk patients, and we are looking forward to making this first and only approved oral penem product available to patients and physicians as efficiently and quickly as we can. So thanks again, and have a great day, everyone.

謝謝，露西。感謝您今天加入我們。我們對 ORLYNVAH 可能在今年第四季上市感到非常興奮。我們相信，對於那些高風險患者來說，簡單尿路感染市場對 ORLYNVAH 的需求確實很大，我們期待著盡可能高效、快速地為患者和醫生提供這種首個也是唯一一個獲批的口服培南產品。再次感謝大家，祝福大家有個愉快的一天。

This concludes today's call. Thank you for joining. You may now disconnect your lines.

今天的電話會議到此結束。感謝您的加入。現在您可以斷開線路了。