Iterum Therapeutics PLC (ITRM) 2021 Q4 法說會逐字稿

Hello, and welcome to the Iterum Therapeutics Fourth Quarter and Full Year 2021 Financial Results Call. My name is Alex, and I'll be coordinating the call today. (Operator Instructions) I will now hand over to your host, Louise Barrett, Senior Vice President of Legal Affairs. Over to you, Louise.

您好，歡迎參加 Iterum Therapeutics 2021 年第四季和全年財務業績電話會議。我叫亞歷克斯，今天我將協調通話。 （操作員指示）現在請主持人，法律事務高級副總裁 Louise Barrett 發言。交給你了，路易絲。

Thanks, Alex. Good morning, and welcome to Iterum Therapeutics Fourth Quarter and Full Year 2021 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.

謝謝，亞歷克斯。早安，歡迎參加 Iterum Therapeutics 2021 年第四季和全年財務業績和業務更新電話會議。今天早上早些時候發布了包含我們第四季度和全年業績的新聞稿，可以在我們的網站上找到。

We are joined this morning by Corey Fishman, our CEO; and Judy Matthews, our CFO. Corey will provide some opening remarks. Judy will provide details on our financial results, and then we will open the lines for Q&A.

今天早上我們的執行長科里·菲什曼 (Corey Fishman) 也加入了我們。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 would just like to remind you that this call will contain forward-looking statements concerning our plans, strategies and prospects for our business, including with respect to planned interactions and communications with the FDA and our ability to reach agreement with the FDA on the design of the post clinical trial. Our expectations with regard to our ability to resolve the matters set forth in the complete response that received in July 2021 and obtain approval for oral sulopenem, the timing and conduct of potential future clinical development of sulopenem and the sufficiency of our cash resources to execute on our strategy.

在我們開始之前，我想提醒您，本次電話會議將包含有關我們的計劃、策略和業務前景的前瞻性陳述，包括與 FDA 計劃的互動和溝通以及我們與 FDA 達成協議的能力FDA 關於臨床後試驗的設計。我們對解決 2021 年 7 月收到的完整答覆中提出的問題並獲得口服磺培南批准的能力、磺培南未來潛在臨床開發的時間和進行以及我們執行的現金資源是否充足的期望我們的策略。

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including uncertainties inherent in the initiation and conduct of clinical development; availability and timing of data from such clinical trials; the timing or likelihood of regulatory filings and approvals, including the potential resubmission of our NDA for oral sulopenem; changes in regulatory requirements, public policy or legislation; the actions of third-party clinical research organizations, suppliers and manufacturers; the accuracy of our expectations regarding how far into the future our cash on hand will fund our ongoing operations, including carrying out proposed additional clinical development of oral sulopenem; the impact of COVID-19 and related response measures thereto; our ability to maintain our listing on the NASDAQ Capital Market; and other risk factors set out in our filings with the SEC, including the most recently filed annual report on Form 10-K.

由於各種重要因素，包括臨床開發啟動和進行中固有的不確定性，實際結果可能與這些前瞻性陳述所示的結果有重大差異；此類臨床試驗數據的可用性和時間安排；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；監管要求、公共政策或立法的變化；第三方臨床研究組織、供應商和製造商的行為；我們對未來多久手頭現金將為我們持續營運提供資金的預期的準確性，包括進行擬議的口服硫培南的額外臨床開發； COVID-19 的影響及其相關應對措施；我們維持在納斯達克資本市場上市的能力；以及我們向 SEC 提交的文件中列出的其他風險因素，包括最近提交的 10-K 表年度報告。

In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. And we specifically disclaim any obligation to update such statements.

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 and have provided a reconciliation of GAAP reported to non-GAAP adjusted information in the press release issued this morning. We believe that the presentation of these measures when viewed as per results under GAAP and the accompanying reconciliation provides useful supplementary information and facilitate additional analysis by our investors, analysts and our management in assessing our performance and results from period-to-period.

我們還將在電話會議期間參考非公認會計準則財務指標，並在今天早上發布的新聞稿中提供了根據非公認會計準則調整後的資訊報告的公認會計準則的調節表。我們相信，根據公認會計原則（GAAP）的結果以及隨附的調節表來看待這些衡量標準，可以提供有用的補充信息，並有助於我們的投資者、分析師和管理層在評估我們的業績和業績時進行額外分析。

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

話雖如此，科里，我會把它交給你做開場白。

Great. Thanks, Louise. Welcome, and thanks for joining us today on our year-end 2021 conference call. I'd like to begin by highlighting that in 2021, we raised a substantial amount of cash and continue to operate our organization in an extremely streamlined fashion. These proactive steps have allowed us to extend our cash runway into 2024 and subject to final determination of design and planned conduct of additional clinical and nonclinical development of oral sulopenem, which I will discuss in more detail later in the call, to carry out the proposed additional development to support, if successful, the resubmission of our NDA to the FDA.

偉大的。謝謝，路易絲。歡迎並感謝您今天參加我們的 2021 年底電話會議。首先，我想強調，2021 年，我們籌集了大量現金，並繼續以極其精簡的方式經營我們的組織。這些積極主動的步驟使我們能夠將現金跑道延長至2024 年，並根據設計的最終確定以及口服硫培南的額外臨床和非臨床開發的計劃進行，我將在稍後的電話會議中更詳細地討論這一點，以執行擬議的計劃如果成功的話，將支持我們向 FDA 重新提交 NDA 的額​​外開發。

We ended 2021 with about $81 million of cash on the balance sheet. Since the end of 2021, there are 2 significant events that I'd like to share. First, we fully repaid our outstanding term loan with Silicon Valley Bank and now have no bank debt at all on the balance sheet.

2021 年底，我們的資產負債表上有約 8,100 萬美元的現金。自 2021 年底以來，我想分享兩件重大事件。首先，我們完全償還了矽谷銀行未償還的定期貸款，現在資產負債表上根本沒有銀行債務。

Additionally, as it relates to compliance with NASDAQ's minimum bid price requirement, in early March, we received a 180-day extension to regain compliance with this requirement. We now have until September 5 to meet this requirement, including by effecting a reverse share split, if necessary.

此外，由於涉及遵守納斯達克的最低買入價要求，3 月初，我們獲得了 180 天的延期，以重新遵守這項要求。我們現在必須在 9 月 5 日之前滿足這項要求，包括在必要時實施反向股份分割。

On the FDA front, over the last few months, we have held 3 substantive meetings and a number of discussions with the agency to talk about the additional clinical work required to support the potential resubmission of our package. Specifically, based on those discussions to date, the FDA has stated they will require an additional Phase III clinical study in uncomplicated urinary tract infection which, if successful, along with our existing data package should support the resubmission of our NDA.

在 FDA 方面，過去幾個月，我們與該機構舉行了 3 次實質會議和多次討論，討論支持可能重新提交我們的方案所需的額外臨床工作。具體來說，根據迄今為止的討論，FDA 表示，他們將需要針對無併發症的泌尿道感染進行額外的III 期臨床研究，如果成功，與我們現有的數據包一起應支持重新提交我們的NDA 。

We are working diligently to align with the FDA on the specifics of this additional clinical study and hope to finalize the details of this study in the second quarter. If we are successful in finalizing the details of that study in the second quarter, we would expect to be in a position to begin this additional Phase III study with oral sulopenem in the second half of this year.

我們正在努力與 FDA 就這項額外臨床研究的具體細節進行協調，並希望在第二季敲定這項研究的細節。如果我們在第二季成功敲定研究的細節，我們預計將能夠在今年下半年開始這項額外的口服硫培南 III 期研究。

Once the design and planned conduct has been finalized, we'll provide an outline of the study and its relevant parameters, including a proposed high-level timeline for enrollment and completion of the study, the likely timing for availability of top line data and if the study is successful, potential timing for resubmission of our NDA.

一旦設計和計劃實施最終確定，我們將提供研究大綱及其相關參數，包括建議的註冊和完成研究的高級時間表、提供頂線數據的可能時間以及如果該研究是成功的，是重新提交我們的NDA 的潛在時機。

As we have said before, we believe that oral sulopenem can play a very important role in the treatment of uncomplicated urinary tract infections in the community for elevated risk patients and those patients with resistant infections. Also, we'd like to thank our investors and stakeholders for their patience as we work diligently with the FDA to define our path forward.

正如我們之前所說，我們相信口服硫培南可以在社區高風險患者和抗藥性感染患者的單純性泌尿道感染治療中發揮非常重要的作用。此外，我們也要感謝投資者和利害關係人在我們與 FDA 努力合作以確定我們的前進道路時所給予的耐心。

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

現在我將把電話轉給朱迪​​，以了解我們財務表現的詳細資訊。

Thanks, Corey. Total operating expenses were $6.8 million and $24.5 million in the fourth quarter and full year 2021 compared to $4.6 million and $32.1 million in the fourth quarter and full year 2020. Operating expenses include research and development expenses and general and administrative expenses.

謝謝，科里。 2021 年第四季和全年的總營運費用分別為680 萬美元和2,450 萬美元，而2020 年第四季和全年的營運費用為460 萬美元和3,210 萬美元。營運費用包括研發費用以及一般和管理費用。

R&D costs were $3.7 million for the fourth quarter of 2021 compared to $2.4 million for the same period in 2020. The primary driver of the $1.3 million increase in R&D costs was noncash amortization of an intangible asset in 2021. Full year R&D costs were $10.7 million in 2021 versus $21.1 million in 2020 as a result of the completion of our Phase III trials in 2020.

2021 年第四季的研發成本為370 萬美元，而2020 年同期為240 萬美元。美元由於 2020 年完成了 III 期試驗，2021 年的銷售額為 2,110 萬美元，而 2020 年為 2,110 萬美元。

G&A costs were $3.1 million for the fourth quarter of 2021, which is $800,000 higher than G&A costs of $2.3 million in the fourth quarter of 2020 due primarily to higher noncash share-based compensation for employees and directors. Full year G&A costs were $13.8 million in 2021 compared to $11.1 million in 2020 or a $2.7 million increase due to higher consulting spend on pre-commercialization activities through the first half of 2021 prior to receiving a CRL in July and higher share-based compensation expense, partially offset by lower G&A headcount.

2021 年第四季的一般管理費用為 310 萬美元，比 2020 年第四季的一般管理費用 230 萬美元高出 80 萬美元，這主要是由於員工和董事的非現金股份薪酬增加。 2021 年全年G&A 成本為1,380 萬美元，而2020 年為1,110 萬美元，增加了270 萬美元，原因是在7 月份收到CRL 之前，2021 年上半年商業化前活動的諮詢支出增加，以及股權激勵費用增加，部分被總務及行政人員人數減少抵銷。

Moving on to nonoperating items. Interest expense was $800,000 for the fourth quarter of 2021 compared to $4.2 million in the fourth quarter of 2020. The primary reason for the $3.4 million decrease in interest expense was noncash interest expense associated with the lower outstanding exchangeable note balance of $12.6 million as of December 31, 2021, versus $51.8 million as of December 31, 2020.

繼續討論非營運項目。 2021 年第四季的利息支出為80 萬美元，而2020 年第四季的利息支出為420 萬美元。利息支出減少340 萬美元的主要原因是與截至12 月未償還可交換票據餘額減少1,260 萬美元相關的非現金利息支出截至 2021 年 12 月 31 日，該數據為 5,180 萬美元。

On a strictly cash basis, we paid interest related to our term loan with SVB of approximately $60,000 in the fourth quarter of 2021 versus approximately $230,000 in the fourth quarter of 2020. The reduction in cash interest is largely due to a lower principal balance on our term loan as monthly amortization began in the fourth quarter of 2019 and continued until our final payment, which was made earlier this month.

在嚴格的現金基礎上，我們在2021 年第四季向SVB 支付了約60,000 美元的定期貸款利息，而2020 年第四季約為230,000 美元。 。

Our net loss on a U.S. GAAP basis was $4.2 million for the fourth quarter of 2021 and $91.6 million for the full year. The full year net loss was primarily driven by noncash fair value adjustments totaling $61 million recorded at the time of conversion of approximately $39 million of the exchangeable notes in 2021. There was no impact of these adjustments 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 2021 年第四季的淨虧損為 420 萬美元，全年淨虧損為 9,160 萬美元。全年淨虧損主要是由於 2021 年約 3,900 萬美元可交換票據轉換時記錄的非現金公允價值調整總計 6,100 萬美元造成的。這些調整對現金或現金跑道沒有影響，我將把這一點轉為到一會兒。

On a non-GAAP basis, which excludes certain noncash adjustments, our net loss of $3.3 million and $19.4 million in the fourth quarter and full year 2021 compared to our non-GAAP net loss of $4.4 million and $30.9 million in the fourth quarter and full year 2020. The $1.1 million and $11.5 million decrease at our non-GAAP net loss for the fourth quarter and full year was as a result of lower operating expenses, as previously discussed.

依照非公認會計準則（不包括某些非現金調整）計算，我們第四季和2021 年全年的淨虧損分別為330 萬美元和1,940 萬美元，而第四季和全年的非公認會計準則淨虧損分別為440 萬美元和3,090 萬美元。2020 年。第四季和全年的非 GAAP 淨虧損分別減少 110 萬美元和 1,150 萬美元，這是由於營運費用降低（如前所述）。

At the end of December, we had cash and short-term investments of $81.3 million. Full year 2021, we spent approximately $16 million or $1.3 million on average per month operating the business on an efficient basis. And we also made loan repayments to SVB of $6.5 million for total cash spend in 2021 of approximately $22.5 million. And as previously mentioned, our final payment to SVB was made earlier in March.

截至 12 月底，我們的現金和短期投資為 8,130 萬美元。 2021 年全年，我們平均每月花費約 1,600 萬美元或 130 萬美元來高效經營業務。我們也向 SVB 償還了 650 萬美元的貸款，2021 年的現金支出總額約為 2,250 萬美元。如同先前所提到的，我們向 SVB 支付的最後一筆款項是在三月初支付的。

Based on our current operating plan and subject to final determination of the design and planned conduct of potential additional clinical and nonclinical development for sulopenem, we have cash into 2024. As such, we expect that our existing cash will be sufficient to allow us to carry out the proposed additional development of oral sulopenem to support this successful resubmission of the NDA to the FDA for the treatment of uUTI.

根據我們目前的營運計劃，並根據最終確定的設計和計劃進行的潛在額外的硫培南臨床和非臨床開發，我們到 2024 年都有現金。因此，我們預計現有現金將足以讓我們進行提出了口服硫培南的擬議額外開發，以支持成功向FDA 重新提交治療uUTI 的NDA。

As of December 31, 2021, we had approximately 183 million ordinary shares outstanding. Also, as of the end of December, we had 7.2 million warrants outstanding at an average price of $1.61 per share and $12.6 million of exchangeable notes, which can be exchanged for approximately 18 million shares, which includes accrued interest at the option of the note holder.

截至2021年12月31日，我們擁有約1.83億股已發行普通股。此外，截至12 月底，我們還有720 萬張已發行認股權證，平均價格為每股1.61 美元，還有1,260 萬美元的可交換票據，可兌換約1,800 萬股股票，其中包括票據選擇的應計利息持有者。

Now I will turn it back over to Corey for some closing comments.

現在我將把它轉回給科里徵求一些結束語。

Great. Thank you, Judy. We'd like to open the line now for any questions.

偉大的。謝謝你，朱迪。如果有任何問題，我們現在願意開通熱線。

(Operator Instructions) Our first question for today comes from Ed Arce of H.C. Wainwright.

（操作員說明）今天我們的第一個問題來自 H.C. 的 Ed Arce。溫賴特。

This is Thomas Yip asking a couple of questions for Ed. Perhaps first question for Corey. As obviously, the most important catalyst this year, Phase III study starting in the second half of this year, can you give us a rough idea on size and primary endpoint and perhaps have a comparator drug been finalized with the FDA yet?

我是 Thomas Yip，向 Ed 問了幾個問題。也許是科里的第一個問題。顯然，今年最重要的催化劑，即今年下半年開始的 III 期研究，您能否給我們一個關於規模和主要終點的粗略想法，也許 FDA 已經最終確定了一種比較藥物？

Thanks, Thomas. We would love to give you that except it has not been finalized yet, and that is part of what we continue to have discussions with the agency on. And as I mentioned, we hope to finalize that in the next quarter.

謝謝，托馬斯。我們很樂意向您提供此訊息，但尚未最終確定，這是我們繼續與該機構討論的一部分。正如我所提到的，我們希望在下個季度完成這項工作。

The endpoint as far as we know, as we sit here today, will be the same endpoint that was in the previous uncomplicated UTI study, which is a combined endpoint of clinical and micro. But the other details have not been finalized and aligned with the agency as of yet. And as soon as we have that, of course, we'll be happy to provide all that information to you.

據我們所知，正如我們今天坐在這裡的，終點將與先前的簡單 UTI 研究中的終點相同，這是臨床和微觀的組合終點。但其他細節尚未最終確定並與該機構保持一致。當然，一旦我們掌握了這些信息，我們將很樂意向您提供所有這些信息。

Understood. And perhaps a follow-up on that. Can you tell us the estimated time frame and perhaps cause of this new Phase III study perhaps relative to the completed Phase III uncomplicated UTI study?

明白了。也許還有後續行動。您能否告訴我們這項新的 III 期研究的預期時間框架以及可能的原因（可能與已完成的 III 期簡單 UTI 研究相關）？

Yes. It's a little hard to do that only because we don't have those parameters defined fully yet with the agency. And therefore, any projection I'd give you wouldn't -- really wouldn't have the veracity that I'd like it to.

是的。要做到這一點有點困難，只是因為我們還沒有與該機構完全定義這些參數。因此，我給你的任何預測都不會——真的不會有我想要的準確性。

We don't know that answer. And it's a little frustrating, of course, for investors and, of course, for us as well as we try to nail that down with the FDA. So I wouldn't want to tell you something that could change in the course of the next couple months.

我們不知道這個答案。當然，對於投資者來說，這有點令人沮喪，當然，對於我們以及我們試圖與 FDA 確定這一點的人來說。所以我不想告訴你未來幾個月可能會改變的事情。

But suffice to say, I think one of the important elements that Judy mentioned and I will cover as well is we have a sufficient cash balance that depending on how that outcome is derived with the agency regarding the size of the study, the comparator, et cetera, we believe we have cash to get into 2024. And that should give us a pretty good chance to finish that study up. That's our current thinking at least.

但我只想說，我認為朱迪提到的、我也將討論的重要因素之一是我們有足夠的現金餘額，這取決於機構如何得出有關研究規模、比較器等的結果等等，我們相信我們有足夠的現金進入2024 年。至少這是我們目前的想法。

Understood. Perhaps one final question for Judy. In the press release, you outlined the Silicon Valley Bank loan repayment. Just want to confirm that there's the 2025 notes. And can you tell us what is the rough amount that was repaid and the primary rationale for repaying the loan?

明白了。也許還有最後一個問題想問朱迪。在新聞稿中，您概述了矽谷銀行貸款償還。只是想確認一下 2025 年的筆記是否存在。您能告訴我們大致還款金額是多少以及償還貸款的主要原因嗎？

Yes. So as you said, we paid off the SVB, the term loan. So we do have the exchangeable note, which I mentioned as well during the call. So we had started out the year with $51.8 million, and we now have only $12.6 million outstanding. The other $39 million, people had converted to shares. So if no one else converts that $12.6 million, along with interest, will be due in January 2025.

是的。正如您所說，我們還清了 SVB（定期貸款）。所以我們確實有可交換的票據，我在電話中也提到過。年初時我們有 5,180 萬美元，現在只有 1,260 萬美元未償還。另外 3,900 萬美元，人們已轉換為股票。因此，如果沒有其他人兌換，這 1,260 萬美元連同利息將於 2025 年 1 月到期。

And Thomas, this is Corey. Just to add to that, important to note because it sounds like you may be under the impression that we paid some of those notes off. Those are conversions or redemptions by the note holders. Those are not anything that Iterum has paid cash to redeem. So that's an important distinction. And as Judy said, those are convertible. And during the early part of '21, a number of folks did convert those notes, but we did not pay any cash to redeem them.

托馬斯，這是科里。補充一點，重要的是要注意，因為聽起來您可能會覺得我們還清了其中一些票據。這些是票據持有人的轉換或贖回。這些不是 Iterum 支付現金兌換的任何東西。所以這是一個重要的區別。正如朱迪所說，這些是可轉換的。在 21 世紀初期，許多人確實兌換了這些紙幣，但我們沒有支付任何現金來兌換它們。

I see. So to clarify, the amount that was repaid this year, March 2022 for the loan, so it would be approximately $12.6 million plus interest?

我懂了。那麼澄清一下，今年（即 2022 年 3 月）償還的貸款金額約為 1,260 萬美元加上利息？

I'm sorry, this year, if you're talking about the SVB term loan that we repaid this year, we had only had about $1.5 million outstanding as of December. We paid that off this first quarter. So that has gone. Again, the $12.6 million, if the note holders do not exchange it, we would have to pay that back in January 2025.

抱歉，今年，如果你談論的是我們今年償還的 SVB 定期貸款，那麼截至 12 月我們只有約 150 萬美元的未償還貸款。我們在第一季還清了這筆錢。所以那已經過去了。同樣，這 1260 萬美元，如果票據持有人不兌換，我們將不得不在 2025 年 1 月償還。

Okay. Okay. Got it. So the amount that was repaid in March -- well, I guess, earlier this month, it would be about $1.5 million.

好的。好的。知道了。所以 3 月償還的金額——嗯，我想，本月早些時候，大約是 150 萬美元。

Yes, about. Yes.

是的，大約。是的。

Okay. All right. Thank you so much for clarifying that. And also, Corey, really appreciate all the details for Phase III. We look forward to trial starting later this year.

好的。好的。非常感謝您澄清這一點。而且，科里，真的很欣賞第三階段的所有細節。我們期待今年晚些時候開始審判。

Thanks, Thomas.

謝謝，托馬斯。

We have no further questions for today. So I'll hand back to Corey Fishman for any closing remarks.

今天我們沒有其他問題了。因此，我將把結束語交給科里·菲什曼 (Corey Fishman)。

Thank you. Just want to close by saying we appreciate you joining our conference call today. We remain confident in the value of oral sulopenem in the community for both patients and physicians. And we will continue to work collaboratively with the FDA to provide the additional clinical data needed for a potential NDA resubmission.

謝謝。最後我想說，我們感謝您今天參加我們的電話會議。我們對口服硫培南在社區中對患者和醫生的價值仍然充滿信心。我們將繼續與 FDA 合作，為潛在的 NDA 重新提交提供所需的額外臨床數據。

We expect our existing cash resources to allow us to operate the company into 2024 and to carry out the proposed additional clinical study subject to final determination of the design of such study. And we look forward to sharing more details with you as they become available in the coming months. Thanks, and have a great day.

我們預計現有的現金資源將使我們能夠將公司運營到 2024 年，並進行擬議的額外臨床研究，具體取決於此類研究設計的最終確定。我們期待在未來幾個月內與您分享更多詳細資訊。謝謝，祝你有美好的一天。

Thank you for joining today's call. You may now disconnect.

感謝您參加今天的電話會議。您現在可以斷開連線。