Iterum Therapeutics PLC (ITRM) 2023 Q4 法說會逐字稿

Hello, everyone, and welcome to the Iterum Therapeutics fourth quarter and full year 2023 financial results and business update. My name is Emily, and I'll be coordinating your call. (Operator Instructions)

大家好，歡迎閱讀 Iterum Therapeutics 2023 年第四季和全年財務業績和業務更新。我叫艾米麗，我會協調您的電話。（操作員說明）

I will now turn the call over to our host, Louise Barrett, Senior Vice President of Legal Affairs. Louise, please go ahead.

現在我將把電話轉給我們的東道主、法律事務高級副總裁路易絲·巴雷特 (Louise Barrett)。路易絲，請繼續。

Thank you, Emily. Good morning and welcome to Iterum Therapeutics' fourth quarter and full year 2023 financial results and business update conference call. Our press release for our fourth quarter and full results was issued earlier this morning and can be found on our website.

謝謝你，艾米麗。早安，歡迎參加 Iterum Therapeutics 第四季度和 2023 年全年財務業績和業務更新電話會議。我們第四季度的新聞稿和完整業績已於今天早上早些時候發布，可以在我們的網站上找到。

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. Judy will provide details on our financial results, and then we'll open the line to Q&A.

今天上午，我們的執行長科里·菲什曼 (Corey Fishman) 也加入了我們的行列。和我們的財務長。朱迪·馬修斯。科里將發表一些開場白。朱迪將提供有關我們財務業績的詳細信息，然後我們將開通問答熱線。

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 levels through the sulopenem.

在我們開始之前，我想提醒您，本次電話會議上提供的一些資訊將包含有關我們的計劃、策略和業務前景的前瞻性陳述，包括硫培南的開發、治療和市場潛力水平。

Our ability to address the deficiencies set out in the complete response letter received from the FDA in July 2021, the expected timing of resubmission of our NDA, the expected timing of review by the of the resubmission by the FDA, the sufficiency of our cash resources to fund our operating expenses into 2025.

我們解決 2021 年 7 月從 FDA 收到的完整回覆信中列出的缺陷的能力、重新提交 NDA 的預期時間、FDA 重新提交的預期審查時間、我們的現金資源是否充足為我們到2025 年的運營開支提供資金。

The term and coverage provided by our patent and other intellectual property rights and the company's strategic process to sell license or otherwise dispose of its rights to sue upon them to maximize shareholder value.

我們的專利和其他智慧財產權提供的期限和覆蓋範圍，以及公司出售許可或以其他方式處置其起訴權利的策略流程，以實現股東價值最大化。

Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside of our control, including uncertainties inherent in the design, initiation and conduct of clinical and nonclinical development, changes on regulatory requirements or decisions, regulatory authorities, the timing or likelihood of regulatory filings and approvals, including the potential resubmission of our NDA for oral sulopenem.

由於我們無法控制的各種因素，包括臨床和非臨床開發的設計、啟動和實施、監管要求或決策的變化、監管機構固有的不確定性，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。 、監管備案和批准的時間或可能性，包括可能重新提交我們的口服硫培南 NDA。

Changes in public policy or legislation, commercialization plans and timelines for sulopenem is approved the accuracy of our expectations regarding how far into the future, our cash in hand will fund ongoing operations.

公共政策或立法、商業化計劃和硫培南時間表的變化得到了批准，這符合我們對未來多久我們手頭現金將為持續運營提​​供資金的預期的準確性。

Our ability to maintain our listing on the Nasdaq capital markets, risks and uncertainties concerning the outcome impact effects and results of our pursuit of strategic alternatives, including the terms, timing, structure, value, benefits and cost of any strategic process.

我們維持在納斯達克資本市場上市的能力、與我們追求策略替代方案的結果影響和結果相關的風險和不確定性，包括任何策略流程的條款、時間安排、結構、價值、收益和成本。

And our ability to complete one at all, whether on attractive terms or at all. And other factors discussed under the caption risk factors in our annual report and Form 10-K filed with the SEC this morning. In addition, any forward-looking statements represent our views only as 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.

以及我們完成一項任務的能力，無論是以有吸引力的條件還是根本不完成。以及我們今天早上向 SEC 提交的年度報告和 10-K 表格中風險因素標題下討論的其他因素。此外，任何前瞻性陳述僅代表我們在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。我們特別聲明不承擔更新此類聲明的義務。

We will also be referencing non-GAAP financial measures during the call, we provided reconciliations of GAAP reported to non-GAAP adjusted information in their press release issued this morning.

我們還將在電話會議期間參考非 GAAP 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 調整資訊的調整表。

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

話雖如此，科里，我現在將其交給您進行開場白。

Thanks, Louise. Good morning and thanks for joining us today. I'd like to provide a brief recap of 2023 and outline our key activities and milestones for 2024.

謝謝，路易絲。早安，感謝您今天加入我們。我想簡要回顧 2023 年，並概述我們 2024 年的主要活動和里程碑。

Overall 2023 was a very good year for Iterum as we completed enrollment in our confirmatory Phase 3 clinical trial in adult women with uncomplicated urinary tract infections called the REASSURE clinical trial. As a reminder, this trial was conducted under special protocol assessment agreement with the FDA and compared to oral Sulopenem to oral Augmentin.

總體而言，2023 年對 Iterum 來說是非常好的一年，因為我們完成了針對患有簡單泌尿道感染的成年女性的驗證性 3 期臨床試驗（稱為 REASSURE 臨床試驗）的入組。提醒一下，該試驗是根據 FDA 的特殊方案評估協議進行的，並將口服舒培南與口服奧格門汀進行了比較。

As many of you know, we were very pleased to recently announce that the REASSURE trial demonstrated that oral sulopenem was noninferior to Augmentin with respect to the trial's primary endpoint, which was overall response, which is the combined clinical cure plus microbiologic eradication at the test-of-cure visit in the microbiological modified intent to treat susceptible populations.

正如你們許多人所知，我們最近非常高興地宣布REASSURE 試驗證明，就試驗的主要終點而言，口服硫培南並不劣於奧格門汀，即總體反應，即臨床治愈加上試驗中微生物根除的綜合反應微生物改良的治癒訪視旨在治療易感人群。

Additionally, oral sulopenem also demonstrated statistically significant superiority to Augmentin in the same patient population. Oral sulopenem also showed consistent efficacy for all key secondary endpoints. Lastly, sulopenem demonstrated a very solid safety profile.

此外，在相同的患者群體中，口服硫培南也顯示出比奧格門汀具有統計學上顯著的優越性。口服硫培南對所有關鍵次要終點也顯示出一致的療效。最後，硫培南表現出非常可靠的安全性。

With regards to the sulopenem patent estate. In addition to the in-license patents we obtained in our original license agreement with Pfizer, we continue to seek opportunities to enhance the long-term protection of sulopenem.

關於硫培南專利權。除了我們在與輝瑞的原始授權協議中獲得的授權專利外，我們還繼續尋求機會加強對硫培南的長期保護。

We now have issued patents directed to the composition of the bilayer tablet of oral sulopenem granted in the US, Japan, Korea, Australia, and these patents will expire no earlier than 2039. We also have an issued patent in the US directed to the method of use of oral sulopenem in treating multiple diseases including uncomplicated urinary tract infections, which are due to expire no earlier than 2039.

目前，我們已經在美國、日本、韓國、澳洲授予了口服硫培南雙層片成分的專利，這些專利將不早於2039年到期。我們也在美國擁有一項專利，涉及使用口服硫培南治療多種疾病的方法，包括單純性泌尿道感染，該專利將於 2039 年到期。

In addition to the in-license and issued patents, we have a number of pending patent applications in the US and other jurisdictions, including Europe and China. We believe that these patents plus our potential data exclusivity would allow oral sulopenem in a long runway to capture value.

除了許可和已頒發的專利外，我們在美國和其他司法管轄區（包括歐洲和中國）還有許多正在申請的專利。我們相信，這些專利加上我們潛在的數據排他性將使口服硫培南在很長的跑道上獲得價值。

I'll spend just a moment now and talk a bit about the market dynamics into which we see sulopenem potentially entering. The uncomplicated urinary tract market is quite large with an estimated 40 million prescriptions annually in the US.

我現在將花一點時間談談我們認為硫培南可能進入的市場動態。簡單的泌尿道市場相當大，美國每年估計有 4000 萬張處方。

It's estimated that approximately two-thirds of those prescriptions are for elevated risk patients, which are the patients that sulopenem would target. Elevated risk patients are elderly patients with diabetes patients with a history of recurrent infections for patients that have co-morbidities that negatively impact their immune system.

據估計，這些處方中大約三分之二是針對高風險患者的，這些患者是硫培南的目標患者。高風險患者是患有糖尿病的老年患者，有反覆感染史的患者，以及患有對其免疫系統產生負面影響的合併症的患者。

There's a significant need for new efficacious and safe oral products to treat uncomplicated urinary tract infections as the existing older oral products are experiencing high and increasing resistance rates as well as exhibiting subpar safety profiles.

由於現有的舊腔室產品的抗藥性率很高且不斷增加，且安全性較差，因此迫切需要新的有效且安全的口腔產品來治療簡單的泌尿道感染。

If approved oral sulopenem would be the first oral sulopenem approved in the United States and one of the first new branded treatments approved in the US for uncomplicated urinary tract infections since the turn of the century.

如果口服硫培南獲得批准，這將是美國批准的第一個口服硫培南，也是自世紀之交以來美國批准的第一個用於治療單純性尿路感染的新品牌治療藥物之一。

Regarding our upcoming milestones, we plan to resubmit our NDA to the FDA in the first half of the second quarter of this year, provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter we received from the FDA in July 2021.

關於我們即將到來的里程碑，我們計劃在今年第二季上半年向 FDA 重新提交 NDA，前提是重新提交的 NDA 解決了我們在 2021 年 7 月從 FDA 收到的完整回覆信中發現的所有缺陷。

We expect the FDA will complete its review and take action in the first half of the fourth quarter of this year, which would be six months from the date the FDA received the resubmitted NDA. As we look at our cash position based on our current operating plan, we have cash on hand to operate the company through the expected the due date early in the fourth quarter of 2024 and into 2025.

我們預計 FDA 將在今年第四季上半年完成審查並採取行動，即自 FDA 收到重新提交的 NDA 之日起六個月。當我們根據目前的營運計畫審視我們的現金狀況時，我們手頭上有現金可以在 2024 年第四季初的預期到期日到 2025 年期間經營公司。

Lastly, as previously stated, we have initiated a strategic process to sell license or otherwise dispose of our rights to sulopenem with the goal of maximizing value for our stakeholders and have engaged a financial advisor to assist management and the Board in evaluating strategic alternatives.

最後，如前所述，我們啟動了一項策略流程，出售許可證或以其他方式處置我們對硫培南的權利，目的是為我們的利害關係人實現價值最大化，並聘請了一名財務顧問來協助管理階層和董事會評估策略替代方案。

Our Board has not set the timetable for completion of this evaluation process, and we do not intend to disclose further developments unless and until it is determined that further disclosure is appropriate or necessary.

我們的董事會尚未設定完成此評估過程的時間表，我們也不打算披露進一步的進展，除非確定進一步披露是適當或必要的。

I'll now turn the call over to Judy for details on our financial results.

我現在將把電話轉給朱迪​​，以了解我們財務表現的詳細資訊。

Thanks, Corey. Total operating expenses for $11.4 million to $47.5 million in the fourth quarter and full year 2023 compared to $7.9 million and $30.4 million in the fourth quarter and full year 2022. Operating expenses include research and development expenses and general and administrative expenses.

謝謝，科里。2023 年第四季和全年的總營運費用為 1,140 萬美元至 4,750 萬美元，而 2022 年第四季和全年的總營運費用為 790 萬美元和 3,040 萬美元。營業費用包括研發費用以及一般及管理費用。

R&D costs were $9.7 million for the fourth quarter and $40 million for the full year 2023 compared to $5.8 million and $17.6 million for the same periods in 2022. The primary driver of the increase in R&D expense for the fourth quarter and full year was cost to support our REASSURE trial which began enrollment in October 2022 and completed enrollment in October 2023, enrolling 2,222 patients.

第四季的研發成本為 970 萬美元，2023 年全年的研發成本為 4,000 萬美元，而 2022 年同期的研發成本為 580 萬美元和 1,760 萬美元。第四季和全年研發費用增加的主要驅動因素是支援我們的 REASSURE 試驗的成本，該試驗於 2022 年 10 月開始入組，並於 2023 年 10 月完成入組，入組了 2,222 名患者。

G&A costs were $1.7 million in the fourth quarter of 2023, which is $400,000 lower than G&A costs of $2.1 million in the fourth quarter of 2022 due primarily to lower legal fees and insurance costs. Full year G&A costs were $7.5 million in 2023, which is $5.3 million lower than G&A costs of $12.8 million in 2022.

2023 年第四季的一般管理費用為 170 萬美元，比 2022 年第四季的一般管理費用 210 萬美元減少了 40 萬美元，這主要是由於法律費用和保險費用降低。2023 年全年 G&A 成本為 750 萬美元，比 2022 年 1,280 萬美元的 G&A 成本低 530 萬美元。

Primarily due to lower share-based compensation expense for employees and directors, lower insurance costs, lower rent expense and a decrease in legal fees associated with the lawsuit filed in August 2021, which was dismissed with prejudice in January 2023, which means the case cannot be brought back to court.

主要是由於員工和董事的股份補償費用減少、保險費用減少、租金費用減少以及與2021 年8 月提起的訴訟相關的法律費用減少，該訴訟於2023 年1 月被有偏見地駁回，這意味著該案不能被帶回法庭。

Our net loss on a US GAAP basis was $12.4 million for the fourth quarter of 2023 and $38.4 million for the full year, impacting the full year net loss was a non-cash adjustment of $11.1 million included in other income and expense in connection with the fair value assessment of our Royalty-Linked Note. There was no impact of this adjustment on cash or cash runway, which I will turn to in a moment.

根據美國公認會計原則，我們2023 年第四季的淨虧損為1,240 萬美元，全年淨虧損為3,840 萬美元，影響全年淨虧損的是與其他收入和支出相關的1,110 萬美元的非現金調整。我們的特許權掛鉤票據的公允價值評估。這次調整對現金或現金跑道沒有影響，我稍後會談到這一點。

On a non-GAAP basis, which excludes certain non-cash adjustments, our net loss of $10.7 million and $43.8 million for the fourth quarter and full year 2023 compared to our non-GAAP net loss of $6.4 million and $22.9 million in the fourth quarter and full year 2022.

以非公認會計準則（不包括某些非現金調整）計算，我們第四季和2023 年全年的淨虧損分別為1,070 萬美元和4,380 萬美元，而第四季的非公認會計準則淨虧損為640 萬美元和2,290 萬美元以及 2022 年全年。

The [$4.3 million and $20.9 million] increase in our non-GAAP net loss for the fourth quarter and full year was primarily a result of higher R&D expenses related to our REASSURE trial as the bulk of the 2,222 patients were enrolled in 2023.

我們第四季和全年的非GAAP 淨虧損增加[430 萬美元和2090 萬美元]，主要是由於與我們的REASSURE 試驗相關的研發費用增加，因為2,222 名患者中的大部分是在2023 年入組的。

At the end of December, we had cash, cash equivalents and short-term investments of $23.9 million, which based on our current operating plan and including amounts raised under our ATM agreement through the end of February 2024 will provide a cash runway into 2025, including through the expected due for date, in the first half of the fourth quarter of 2024.

截至 12 月底，我們的現金、現金等價物和短期投資為 2,390 萬美元，根據我們目前的營運計劃，包括截至 2024 年 2 月底根據 ATM 協議籌集的金額，將為 2025 年提供現金跑道，包括預計截止日期（2024 年第四季上半年）。

We expect to resubmit to the FDA, the NDA will also plan for the treatment of uUTI in the first half of the second quarter of 2024 over the next four to six weeks. As of February 29, 2024, we had approximately 16.4 million ordinary shares outstanding.

我們預計將重新向 FDA 提交，NDA 也將計劃在未來 4 至 6 週內於 2024 年第二季上半段用於治療 uUTI。截至 2024 年 2 月 29 日，我們擁有約 1,640 萬股已發行普通股。

Also, as of the end of February 2024, we had approximately $11.1 million of exchangeable notes outstanding, which can be exchanged at the option of the note holder of approximately 1.2 million shares. If the notes are not exchanged prior to maturity, we will be obligated to pay the note holders of $11.1 million plus accrued interest in January 2025.

此外，截至 2024 年 2 月底，我們還有約 1,110 萬美元的未償可交換票據，票據持有人可以選擇交換約 120 萬股股票。如果票據未在到期前交換，我們將有義務在 2025 年 1 月向票據持有人支付 1,110 萬美元以及應計利息。

Now I will turn it back over to Corey.

現在我將把它轉回給科里。

Thanks, Judy. We'll go ahead and open the line for questions now.

謝謝，朱迪。我們現在就開始提問。

(Operator Instructions)

（操作員說明）

Ed Arce, H.C. Wainwright.

埃德·阿爾塞，H.C.溫賴特。

Hi, good morning, everyone. This is Thomas Yip asking a couple of questions were asked. Thank you for taking the questions. So first question we have just wondering, do you have any specific date or triggering events to decide on your strategic options considering that's due for as expected that's you specified earlier early fourth quarter and that cash runway into 2025 inside you have some practically there.

嗨，大家早安。這是Thomas Yip 提出的幾個問題。感謝您提出問題。因此，我們想知道的第一個問題是，您是否有任何具體日期或觸發事件來決定您的戰略選擇，考慮到這是您在第四季度初指定的預期，並且到2025 年的現金跑道實際上已經存在。

Thanks, Thomas. Appreciate the question. We don't have any specific dates or triggering events with regard to the strategic options and primarily because as most folks know, these processes take whatever time is required on a counterparty side to figure out whether there's something that is of interest to them.

謝謝，托馬斯。感謝這個問題。我們沒有關於戰略選擇的任何特定日期或觸發事件，主要是因為正如大多數人所知，這些流程需要交易對手方所需的任何時間來弄清楚是否有他們感興趣的東西。

And we just don't know how long that process takes. So as we said in our remarks, we're not going to talk about it on each of our calls because at the appropriate time, if and when there's something to disclose, we will of course do that. But until then we don't have any specific dates or timelines on that.

我們只是不知道這個過程需要多長時間。因此，正如我們在發言中所說，我們不會在每次通話中都討論這一點，因為在適當的時候，如果有什麼需要披露的時候，我們當然會這樣做。但在那之前我們還沒有任何具體的日期或時間表。

Understood. Perhaps a while we understand that the timing details is still up in the air. So will you consider an option, whether it's indication-specific as we understand the NDA resubmission for uncomplicated uUTI, would you consider carving out other indications possible sulopenem and also for geographic areas as well or would certainly consider sulopenem as a single package?

明白了。也許過了一段時間我們就會明白，時間細節仍然懸而未決。那麼，您是否會考慮一個選項，無論它是針對特定適應症的，因為我們了解重新提交針對簡單性uUTI 的新藥申請，您是否會考慮制定其他可能的適應症，包括舒洛培南以及地理區域，還是一定會考慮舒洛培南作為單一包裝？

Yeah, it's another good question, and we have flexibility on all of those fronts depending on how those conversations go, you bring up a very good point. There's potential for carving up different areas depending on transaction and there's also potential on other indications as well.

是的，這是另一個好問題，我們在所有這些方面都有靈活性，這取決於這些對話的進展情況，你提出了一個非常好的觀點。根據交易情況，有可能劃分不同的領域，在其他指標上也有可能。

So we have flexibility on the company side and again, it's just all a matter of the conversations with other parties as to what they're looking for. But the short answer is yes, we certainly consider any or all of those options potential opportunities.

因此，我們在公司方面擁有靈活性，而且，這只是與其他方就他們正在尋找的東西進行對話的問題。但簡短的答案是肯定的，我們當然會考慮任何或所有這些選項的潛在機會。

Understood. Thank you again for taking our questions, and we look forward to the NDA resubmission closing.

明白了。再次感謝您提出我們的問題，我們期待 NDA 重新提交的結束。

Thanks, Tom.

謝謝，湯姆。

Jason McCarthy, Maxim Group.

傑森麥卡錫，馬克西姆集團。

Thanks, Corey. Thanks for taking the questions. Is Iterum still actively or planning to engage physicians and practices. I guess on an educational level to talk about sulopenem ahead of any type of divestiture or partnering or the focus just getting the NDA done getting to the finish line and seeking to divest or sell the license?

謝謝，科里。感謝您提出問題。Iterum 是否仍在積極或計劃聘請醫生和實踐？我想在教育層面上，在任何類型的剝離或合作之前談論硫培南，或者重點只是完成 NDA 到達終點線並尋求剝離或出售許可證？

Yeah. Thanks, Jason, for the question. The primary focus is going to be around the strategic opportunities and there is a little bit of work ongoing on the commercial side to continue to refine the parameters of the potential commercialization, which could of course, be used by a counterparty at the appropriate time.

是的。謝謝傑森的提問。主要焦點將圍繞戰略機遇，商業方面正在進行一些工作，以繼續完善潛在商業化的參數，當然，交易對手可以在適當的時候使用這些參數。

I don't think you'll see us at this point spending an awful lot of time out in the physician world, but we will of course, continue to do things like presented conferences put together manuscripts, et cetera, which also help get that message out that is still ongoing and will be ongoing as we continue down the road with sulo.

我認為您現在不會看到我們在醫生世界中花費大量時間，但我們當然會繼續做一些事情，例如召開會議、整理手稿等，這也有助於實現這一點傳達的信息仍在繼續，並且隨著我們繼續與sulo 一起前進，這一訊息將會持續下去。

Got it and does sulo qualify or couldn't qualify ultimately under the past our act, if it should get cleared by congress, obviously there is always challenges in getting things done in congress these days, but it is one of the pure bipartisan bill that is out there in the Senate and that they've heard that it's getting closer and closer. And I wonder sulo could be in that discussion for a kind of, quote-unquote, critical need antimicrobial drug?

明白了，根據我們過去的法案，蘇洛最終是否符合資格，如果國會批准的話，顯然現在在國會完成工作總是存在挑戰，但這是純粹的兩黨法案之一參議院就在那裡，他們聽說它越來越近了。我想知道 sulo 是否可以參與討論一種急需的抗菌藥物？

Yeah, I believe sulo would because of the coverage that it's got on those critical pathogens, much like we have qualified infectious disease product designation from the FDA through the gain act. I believe that sulo would be applicable for anything that would come through under the past direct as well.

是的，我相信 sulo 會因為它對那些關鍵病原體的覆蓋範圍，就像我們透過增益法案從 FDA 獲得了合格的傳染病產品指定一樣。我相信 sulo 也適用於過去直接發生的任何事情。

Got it. Thanks, Cory.

知道了。謝謝，科里。

Thanks, Jason.

謝謝，傑森。

We have no further questions, so I'll turn the call back to Corey for closing remarks.

我們沒有其他問題了，所以我將把電話轉回給科里做結束語。

Thank you. We appreciate you joining us today. 2023 was a strong year for Iterum, and we're looking forward to 2024, which we will and which will include resubmitting our NDA for oral sulopenem working with the FDA during the review period with an eye toward potentially bringing this important treatment to patients and physicians in the underserved market of uncomplicated urinary tract infections. Thanks again, and have a good day.

謝謝。我們感謝您今天加入我們。 2023 年對 Iterum 來說是強勁的一年，我們期待 2024 年，我們將在審查期間與 FDA 合作重新提交我們的口服磺培南 NDA，著眼於有可能為患者帶來這種重要的治療方法醫療服務匱乏的單純性泌尿道感染市場的醫師。再次感謝，祝你有美好的一天。

Thank you, everyone, for joining us today. This concludes our call. You may now connect your lines.

謝謝大家今天加入我們。我們的通話到此結束。現在您可以連接線路了。