Iterum Therapeutics PLC (ITRM) 2024 Q4 法說會逐字稿

Hello, everyone, and welcome to the Iterum Therapeutics PLC Fourth-Quarter and Full Year 2024 Financial Results. My name is Ezra, and I will be your coordinator today. (Operator Instructions) I will now hand you over to Louise Barrett, Senior Vice President, Legal Affairs, to begin. Louise, please go ahead.

大家好，歡迎關注 Iterum Therapeutics PLC 2024 年第四季和全年財務業績。我的名字是埃茲拉 (Ezra)，今天我將擔任您的協調員。（操作員指示）現在，我將把您交給法律事務高級副總裁 Louise Barrett 來開始。路易絲，請繼續。

Thank you Ezra. Good morning and welcome to Interim Therapeutics Fourth-Quarter and Full Year 2024 Financial Results and Business Update Conference Call. A press release with our fourth-quarter and full year results was issued earlier this morning and can be found on our website. We are joined this morning by our Chief Executive Officer, Corey Fishman, and Chief Financial Officer, Judith Matthews. Corey will provide some opening remarks, Judith will provide details on our financial results, and then we'll open the lines to Q&A.

謝謝你，以斯拉。早安，歡迎參加 Therapeutics 2024 年第四季度和全年中期財務業績和業務更新電話會議。我們今天早上發布了一份關於第四季度和全年業績的新聞稿，可以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 Judith Matthews 與我們一起出席了會議。Corey 將致開幕詞，Judith 將介紹我們的財務結果的詳細信息，然後我們將開始問答環節。

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, therapeutic, and market potential of ORLYNVAH; the sufficiency of our cash resources to fund operating expenses into the second-half of 2025; our strategic process to sell, license, or otherwise dispose of our rights to ORLYNVAH; our ability to complete pre-commercialization activities for ORLYNVAH; or our ability to develop a commercial launch plan, either directly or with a commercial partner, if we are unsuccessful in entering into or completing a strategic transaction; and the expected issuance of patents in the term and coverage provided by such patents on issue.

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的業務計劃、策略和前景的前瞻性陳述，包括 ORLYNVAH 的開發、治療和市場潛力；我們的現金資源是否足以支付 2025 年下半年的營運費用；我們出售、授權或以其他方式處置我們對 ORLYNVAH 的權利的策略流程；我們完成 ORLYNVAH 預商業化活動的能力；或者如果我們未能成功達成或完成策略交易，我們直接或與商業夥伴一起制定商業發布計劃的能力；以及預期頒發的專利的期限和頒發的專利的覆蓋範圍。

Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside of our control, including but not limited to: risks and uncertainties concerning the outcome impact effects and results of our evaluation of strategic alternatives, including the terms, timing, structure, value, benefits, and costs of any strategic alternative; our ability to complete a strategic alternative transaction; our ability to raise sufficient capital and successfully prepare and implement commercialization plans for ORLYNVAH, with a commercial partner or directly, if we were unsuccessful in entering into or completing a strategic transaction; the market opportunity for and the potential market acceptance of ORLYNVAH; our ability to continue as a going concern the accuracy of our expectations regarding how far into the future our cash-in-hand will fund our ongoing operations; and other factors discussed under the caption risk factors in the annual report filed with the SEC this morning, and other documents filed with the SEC from time to time.

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有重大差異，包括但不限於：與我們對策略替代方案的評估的結果影響效果和結果有關的風險和不確定性，包括任何策略替代方案的條款、時間、結構、價值、效益和成本；我們完成戰略替代交易的能力；如果我們未能達成或完成策略交易，我們是否有能力與商業夥伴或直接為 ORLYNVAH 籌集足夠的資金並成功準備和實施商業化計劃； ORLYNVAH 的市場機會和潛在市場接受度；我們持續經營的能力；我們對於未來現金流能為我們的持續經營提供多大支持所抱持的準確預期；以及今天上午向美國證券交易委員會提交的年度報告中「風險因素」標題下討論的其他因素，以及不時向美國證券交易委員會提交的其他文件中的討論。

In addition, any forward-looking statements represent only our views as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. We will also be referencing non-GAAP financial measures during the call. We have provided reconciliations of GAAP reported to non-GAAP adjusted information in the press release issued this morning.

此外，任何前瞻性陳述僅代表我們截至本次電話會議之日的觀點，不應被視為代表我們在任何後續日期的觀點。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 調整資訊的對帳表。

Now with that all said, I'll turn it over to you, Corey, for your opening remarks.

現在，我已經說了這麼多，接下來，我將把時間交給你，科里，請你致開場白。

Thanks, Louise. Welcome and thanks for joining us today. I'd like to provide a brief recap of 2024 and talk a bit about key activities and milestones in 2025. Overall, 2024 was a very good year for Iterum.

謝謝，路易絲。歡迎並感謝您今天加入我們。我想簡要回顧一下 2024 年，並談談 2025 年的主要活動和里程碑。總體而言，2024 年對 Iterum 來說是非常好的一年。

In January, we generated positive results in our pivotal Phase 3 REASSURE clinical trial, comparing oral sulopenem in adult women with uncomplicated urinary tract infections, efficiently pulled together our NDA resubmission, which was submitted in April. In September, we had a successful advisory committee meeting. And in October of 2024, received FDA approval for ORLYNVAH, the brand name for our oral sulopenem bilayer product.

今年 1 月，我們在關鍵的 3 期 REASSURE 臨床試驗中取得了積極成果，該試驗比較了口服磺胺培南對患有無併發症尿路感染的成年女性的效果，並高效地完成了 NDA 重新提交，並於 4 月提交了該申請。九月份，我們成功地召開了顧問委員會會議。並於2024年10月獲得FDA批准ORLYNVAH，這是我們口服磺胺培南雙層產品的品牌名稱。

ORLYNVAH is indicated for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms E. coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. ORLYNVAH is the first and only approved oral penem in the United States.

ORLYNVAH 適用於治療由指定微生物大腸桿菌、肺炎克雷伯菌或奇異變形桿菌引起的無併發症泌尿道感染，適用於沒有或僅有有限其他口服抗菌治療選擇的成年女性。ORLYNVAH 是美國第一個也是唯一一個核准的口服培南藥物。

Now, I'll share a few comments with you as to why we are so excited about the potential for ORLYNVAH in the market. The uncomplicated urinary tract infection market in the US is quite large and generates an estimated $40 million prescriptions annually. ORLYNVAH is the first and only oral penem approved in the United States, and the second FDA approved treatment for uncomplicated urinary tract infections in the past two decades.

現在，我將與大家分享一些評論，說明我們為何對 ORLYNVAH 在市場上的潛力如此興奮。美國無複雜性泌尿道感染市場規模相當大，每年產生約 4,000 萬美元的處方。ORLYNVAH 是美國第一個也是唯一一個核准的口服培南藥物，也是過去二十年來 FDA 核准的第二個用於治療無併發症泌尿道感染的藥物。

ORLYNVAH will potentially be the first branded product to enter the uncomplicated urinary tract infection market in over 25 years. The leading product in the uncomplicated urinary tract infection market, Nitrofurantoin, was approved in 1953. And the majority of the other oral products in the market were approved in the 1970s and 1980s.

ORLYNVAH 有可能成為 25 年來首個進入非複雜性泌尿道感染市場的品牌產品。無複雜性泌尿道感染市場的主導產品呋喃妥因於 1953 年獲得批准。市場上大多數其他口服產品都是在1970年代和1980年代獲得批准的。

The extensive use of these products over time has led to rising resistance rates, resulting in the most widely used products having resistance rates approaching 20%, and those rates can run as high as 30%. As most prescribing for uncomplicated urinary tract infections occurs empirically, increasing resistance rates creates a challenge for practicing physicians since the efficacy of these products are continuing to be eroded over time.

這些產品的廣泛使用隨著時間的推移導致抗藥性上升，導致使用最廣泛的產品的抗藥性率接近20％，而這一比例最高可達30％。由於大多數針對無複雜性泌尿道感染的處方都是經驗性的，因此抗藥性的上升給執業醫師帶來了挑戰，因為這些產品的功效會隨著時間的推移而不斷減弱。

Additionally, almost all of the widely used oral products in this therapy area have some safety concerns that again create challenges for treating physicians as to the choice of agent to use. Unfortunately, with almost no innovation in decades, physicians have been forced to use agents that may not work as well as they would like for their patients. With the ORLYNVAH approval, there now could be an alternative treatment option for those patients who have limited or no other oral treatment options available.

此外，該治療領域中幾乎所有廣泛使用的口服產品都存在一些安全問題，這再次給治療醫生在選擇使用哪種藥物方面帶來了挑戰。不幸的是，幾十年來幾乎沒有任何創新，醫生被迫使用可能對病人效果不盡人意的藥物。隨著 ORLYNVAH 的批准，對於那些口服治療選擇有限或沒有其他治療選擇的患者來說，現在可能有一種替代治療選擇。

We believe that there are many patients that fall into this category, specifically elevated risk patients. We define elevated risk patients as women that fall into any of the following categories: women who are 65 years or older, women who have diabetes, women with a history of recurrent or drug-resistant infections, or women that have other comorbidities that negatively impact their immune systems. This group of patients are most at risk given their profiles, and many physicians are challenged to treat these patients with existing oral options that have substantial resistance as well as safety hurdles.

我們相信有很多患者屬於這一類別，特別是高風險患者。我們將高風險患者定義為屬於以下任一類別的女性：65 歲或以上的女性、患有糖尿病的女性、有復發性或抗藥性感染病史的女性，或患有其他對免疫系統產生負面影響的合併症的女性。鑑於這類患者的特點，他們面臨的風險最大，而許多醫生面臨的挑戰是使用現有的口服藥物來治療這些患者，因為這些藥物存在很大的阻力和安全障礙。

Another key group of patients in this therapy area that are in significant need of a new efficacious and safe oral treatment alternative are the patients that have pathogens resistant to all commonly used oral antibiotics. In our REASSURE uncomplicated urinary tract infection clinical trial, pleaded last year and conducted exclusively in the US, across almost 1,000 patients, we found that approximately 1% of these patients had an isolate that was resistant to all available oral antibiotics. ORLYNVAH could play an important role in treating these patients as well.

該治療領域的另一組關鍵患者急需一種新的有效、安全的口服治療方案，他們就是對所有常用口服抗生素具有抗藥性的患者。在我們去年發起並在美國獨家進行的 REASSURE 無複雜性泌尿道感染臨床試驗中，我們涉及近 1,000 名患者，發現其中約 1% 的患者體內的分離菌對所有現有的口服抗生素均具有抗藥性。ORLYNVAH 在治療這些患者方面也能發揮重要作用。

As we look at protection for ORLYNVAH, with the formal confirmation from the FDA of five additional years of marketing exclusivity under the GAIN Act, ORLYNVAH has market exclusivity for a total of 10 years from the date of approval or until October 25th, 2034. Additionally, our US patent portfolio provides protection for ORLYNVAH into 2039, with issued US patents covering both method of use and composition of matter.

當我們看到對 ORLYNVAH 的保護時，隨著 FDA 根據 GAIN 法案正式確認額外五年的市場獨佔權，ORLYNVAH 自批准之日起或至 2034 年 10 月 25 日共擁有 10 年的市場獨佔權。此外，我們的美國專利組合為 ORLYNVAH 提供至 2039 年的保護，其中已頒發的美國專利涵蓋使用方法和物質組成。

I submitted patent information for four US patents for ORLYNVAH that are listed in FDA's Orange Book, Approved Drug Products With Therapeutic Equivalence Evaluations. Overall, we're very pleased with the amount of protection that ORLYNVAH should have in the US market to capture value without competition from a potential generic product. In addition to the in-license and issue patents we have, there are a number of pending patent applications in the US and other jurisdictions including Europe and China.

我提交了 ORLYNVAH 的四項美國專利信息，這些專利均列在 FDA 橙皮書《經治療等效性評估批准的藥品》中。總體而言，我們對 ORLYNVAH 在美國市場上獲得的保護程度感到非常滿意，該藥物能夠在沒有潛在仿製藥競爭的情況下獲取價值。除了我們擁有的許可和頒發的專利之外，還有許多在美國和歐洲、中國等其他司法管轄區正在等待審理的專利申請。

As we enter 2025, there are a few items to note. Our key priority remain the previously announced strategic process to sell, license, or otherwise dispose of our rights to ORLYNVAH with the goal of maximizing value for our stakeholders. Along with our financial adviser, we have conducted outreach to dozens of companies since our approval, and have and will continue to engage with those that are potentially interested in a strategic transaction.

當我們進入 2025 年時，有幾點需要注意。我們的首要任務仍然是先前宣布的出售、授權或以其他方式處置我們對 ORLYNVAH 的權利的策略流程，目標是為我們的利害關係人實現價值最大化。自從獲得批准以來，我們與財務顧問一起聯繫了數十家公司，並且已經並將繼續與那些可能對策略交易感興趣的公司接觸。

As neither interim nor our financial advisor appointed to assist the Board in evaluating various strategic alternatives is in control of whether our efforts on the strategic front will result in any definitive offer to consummate such a transaction; or if we do receive a definitive offer, whether the terms are as favorable and anticipated or acceptable to the Board.

由於無論是臨時顧問還是我們被任命協助董事會評估各種戰略替代方案的財務顧問都無法控制我們在戰略方面的努力是否會產生任何最終的要約來完成此類交易；或者如果我們確實收到了最終報價，其條款是否有利、是否為董事會所預期或接受。

In parallel to the strategic process, we have begun to evaluate other options for maximizing the value of ORLYNVAH, which may include seeking to raise capital to support the commercialization of ORLYNVAH. We plan to engage in pre-commercial activities in order to develop the foundation for a highly targeted launch of ORLYNVAH, with a commercial partner or directly, subject to raising sufficient capital to ensure that the product is made available to patients and physicians as soon as possible.

在策略進程的同時，我們已經開始評估最大化 ORLYNVAH 價值的其他選擇，其中可能包括尋求籌集資金來支持 ORLYNVAH 的商業化。我們計劃與商業夥伴或直接進行商業化前活動，為高度有針對性地推出 ORLYNVAH 奠定基礎，但須籌集足夠的資金，確保盡快向患者和醫生提供該產品。

On the financial side, we have repaid the principal and interest due under our exchangeable notes at the end of January in accordance with their terms. Additionally, based on our current operating plan, including currently planned pre-commercialization activities, we expect our cash will be sufficient to fund operations into the second-half of 2025.

在財務方面，我們已按照可交換票據的條款於 1 月底償還了到期的本金及利息。此外，根據我們目前的營運計劃，包括目前計劃的商業化前活動，我們預計我們的現金將足以資助到 2025 年下半年的營運。

Now I'll turn the call over to Judith Matthews, our CFO, for a financial update.

現在我將把電話轉給我們的財務長 Judith Matthews，來報告財務最新情況。

Thanks, Corey. Total operating expenses were $3.7 million in the fourth quarter, and $18.7 million for the full year 2024, compared to $11.4 million and $47.5 million in the fourth quarter and full year 2023. Our operating expenses include cost of sales, which is primarily the amortization of an intangible asset; research and development expenses; and general and administrative expenses.

謝謝，科里。第四季總營運費用為 370 萬美元，2024 年全年總營運費用為 1,870 萬美元，而 2023 年第四季和全年分別為 1,140 萬美元和 4,750 萬美元。我們的營業費用包括銷售成本，主要是無形資產的攤提；研究及開​​發費用；以及一般及行政費用。

R&D costs were $1.3 million for the fourth quarter, and $10.5 million for the full year 2024, compared to $9.7 million and $40 million for the same periods in 2023. The primary driver of the decrease in R&D expense for the fourth quarter and full year was the completion of the REASSURE trial.

2024 年第四季的研發成本為 130 萬美元，全年研發成本為 1,050 萬美元，而 2023 年同期的研發成本分別為 970 萬美元及 4,000 萬美元。第四季和全年研發費用下降的主要動力是 REASSURE 試驗的完成。

G&A costs were $2.1 million for the fourth quarter and $8 million for the full year 2024, compared to G&A cost of $1.7 million and $7.5 million for the same period in 2023. The primary driver of the increase in G&A expense for the fourth quarter and full year was higher legal fees.

2024 年第四季的 G&A 成本為 210 萬美元，全年的 G&A 成本為 800 萬美元，而 2023 年同期的 G&A 成本分別為 170 萬美元和 750 萬美元。第四季和全年一般及行政費用增加的主要原因是法律費用的增加。

Our net loss on a US GAAP basis was $6.6 million for the fourth quarter of 2024, and $24.8 million for the full year. On a non-GAAP basis, which excludes certain non-cash adjustments, our net loss of $3.1 million (sic - see press release, "$3.4 million) and 17.6 million (sic - see press release, "$17.9 million) for the fourth quarter and full year 2024, compared to our non-GAAP net loss of $10.7 million and $43.8 million for the fourth quarter and full year 2023. The $7.6 million and $26.2 million decrease in our non-GAAP net loss for the fourth quarter and full year was primarily a result of lower R&D expenses related to our REASSURE trial.

根據美國 GAAP 計算，我們的 2024 年第四季淨虧損為 660 萬美元，全年淨虧損為 2,480 萬美元。在非 GAAP 基礎上，不包括某些非現金調整，我們的 2024 年第四季度和全年淨虧損為 310 萬美元（原文如此 - 參見新聞稿，“340 萬美元”）和 1,760 萬美元（原文如此 - 參見新聞稿，“1,790 萬美元”），而我們的非 GAAP,380 萬美元與第四季度淨 20 萬美元和 20 萬美元淨額為 130 萬美元和 23 萬美元。我們第四季和全年非公認會計準則淨虧損分別減少 760 萬美元和 2,620 萬美元，主要是由於 REASSURE 試驗相關的研發費用降低。

At the end of December, we had cash and cash equivalents of $24.1 million based on our current operating plan, which includes our currently planned pre-commercialization fund. We expect that our cash and cash equivalents, including $4.8 million of net proceeds raised under our ATM from January 1 through February 6, 2025, will be sufficient to fund our operations into the second half of 2025.

截至 12 月底，根據我們目前的營運計劃，我們的現金和現金等價物為 2,410 萬美元，其中包括我們目前計劃的商業化前基金。我們預計，我們的現金和現金等價物（包括 2025 年 1 月 1 日至 2 月 6 日期間透過 ATM 籌集的 480 萬美元淨收益）將足以資助我們到 2025 年下半年的營運。

Pursuant to our exclusive license with Pfizer for sulopenem, we were obligated to make a regulatory milestone payment of $20 million to Pfizer upon approval of oral sulopenem. In accordance with the license, we elected to defer payment for two years and delivered a promissory note to Pfizer in the amount of $20 million in October 2024. This note accrues interest at an annual rate 8% on a daily compounded basis until paid in full.

根據我們與輝瑞公司簽訂的舒洛培南獨家許可，我們有義務在口服舒洛培南獲得批准後向輝瑞公司支付 2000 萬美元的監管里程碑付款。根據許可，我們選擇延期兩年付款，並於2024年10月向輝瑞公司交付了2000萬美元的本票。本票以日複利以年利率 8% 計息，直至全額償付。

On January 31, 2025, we repaid the outstanding principal and interest due under the exchangeable notes in accordance with their terms. As of February 6, 2025, we had approximately $34.6 million ordinary shares outstanding.

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 2 月 6 日，我們已發行約 3,460 萬美元的普通股。

We will now open it up for questions.

我們現在開始回答問題。

(Operator Instructions) Ed Arce, H.C. Wainwright.

(操作員指示) Ed Arce，H.C.溫賴特。

Hello. Good morning, everyone. This is Thomas asking a couple of questions for Ed. Thank you so much for taking questions. Perhaps first question, I wonder if you can discuss any feedback or details on your ongoing discussions with potential partners? And also, if you can discuss what type of entities are you having discussions with such as pharma companies or financial organizations? What type of partners are you seeking out currently?

你好。大家早安。這是湯瑪斯向艾德問的幾個問題。非常感謝您回答問題。也許第一個問題是，我想知道您是否可以討論與潛在合作夥伴正在進行的討論中的任何反饋或細節？另外，您能否討論一下您正在與哪些類型的實體進行討論，例如製藥公司或金融機構？您目前正在尋找什麼類型的合作夥伴？

Thanks for the question, Thomas. As you'd imagine, we really can't talk in detail about any ongoing conversations. What I will say is, as I mentioned, is we have had outreach to dozens of companies which include both pharma companies as well as financial investors and that process is ongoing.

謝謝你的提問，托馬斯。正如您所想像的，我們確實無法詳細談論任何正在進行的對話。我想說的是，正如我所提到的，我們已經聯繫了數十家公司，其中既包括製藥公司，也包括金融投資者，而且這個過程正在進行中。

Understood. And then on the other side, you mentioned that there are four commercial preparations are ongoing. I wonder if you can highlight some activities on that front.

明白了。另一方面，您提到有四項商業準備正在進行中。我想知道您是否可以重點介紹這方面的一些活動。

Yeah. So we are currently engaging in some research with payers, with physicians. We're also doing some analytics around targeting around geographies. All in the in the stead of putting the foundation in place should we end up in a place where the strategic transaction does not occur, or the strategic transaction doesn't generate something that is sufficient in the Board's eyes for a commercial launch either by us or with a commercial partner here in the room.

是的。因此，我們目前正在與付款人和醫生進行一些研究。我們也針對地理定位進行了一些分析。總而言之，如果我們最終無法達成策略交易，或者策略交易在董事會看來無法產生足夠的成果以供我們或在座的商業夥伴進行商業發布，那麼我們就沒有奠定基礎。

Understood. That's all the questions left for now. Thank you so much for taking the questions and looking forward to progress in the ongoing discussions.

明白了。目前剩下的問題就這些了。非常感謝您回答這些問題，我們期待接下來的討論能取得進展。

Thanks, Thomas.

謝謝，托馬斯。

(Operator Instructions) We currently have no more questions. I will hand back over to Corey Fishman for any closing remarks.

（操作員指示）我們目前沒有其他問題。我將把發言權交還給 Corey Fishman 做結束語。

Thank you. We appreciate you joining us today. 2024 is a pivotal year for Iterum as we received our FDA approval for ORLYNVAH, the first and only oral penem approved in the US. We believe the uncomplicated urinary tract infection market is underserved and that there is a substantial unmet need for effective treatment options. We look forward to ORLYNVAH entering the US market and ensuring that ORLYNVAH is made available to patients and physicians in order to provide this important treatment option to treat uncomplicated urinary tract infections. Thanks again and have a good day.

謝謝。感謝您今天加入我們。 2024 年對 Iterum 來說是關鍵的一年，因為我們獲得了 FDA 批准的 ORLYNVAH，這是美國批准的第一個也是唯一一個口服培南藥物。我們認為，簡單尿路感染市場服務不足，對有效治療方案的需求還遠未滿足。我們期待ORLYNVAH進入美國市場，並確保患者和醫生能夠使用ORLYNVAH，以提供這種治療無併發症泌尿道感染的重要治療選擇。再次感謝並祝您有美好的一天。

Thank you very much, Corey, and thank you all our speakers on today's call. This concludes today's conference call. You may now disconnect your lines.

非常感謝，科里，也感謝今天電話會議的所有發言者。今天的電話會議到此結束。現在您可以斷開線路了。