Lexicon Pharmaceuticals Inc (LXRX) 2023 Q1 法說會逐字稿

Good day, everyone, and welcome to the Lexicon Pharmaceuticals First Quarter 2023 Financial Results Conference Call. (Operator Instructions). Please also note that today's event is being recorded.

大家好，歡迎參加 Lexicon Pharmaceuticals 2023 年第一季度財務業績電話會議。 （操作員說明）。另請注意，今天的活動正在錄製中。

And at this time, I'd like to turn the floor over to Carrie Siragusa. Ma'am, please go ahead.

現在，我想把發言權交給 Carrie Siragusa。女士，請繼續。

Thank you, Jamie. Good afternoon, and welcome to the Lexicon Pharmaceuticals First Quarter 2023 Financial Results Conference Call. Joining me today are Lonnel Coats, Lexicon's Chief Executive Officer; Jeff Wade, Lexicon's President and Chief Financial Officer; and Dr. Craig Granowitz, Lexicon's Senior Vice President and Chief Medical Officer. Earlier this afternoon, Lexicon issued a press release announcing our financial results for the first quarter of 2023, which is available on our website at www.lexpharma.com and through our SEC filings. A webcast of this call, along with a slide presentation, is available on our website. During this call, we will review the information provided in the release, provide a corporate update and then use the remainder of our time to answer your questions.

謝謝你，傑米。下午好，歡迎參加 Lexicon Pharmaceuticals 2023 年第一季度財務業績電話會議。今天加入我的是 Lexicon 首席執行官 Lonnel Coats； Jeff Wade，Lexicon 總裁兼首席財務官； Lexicon 高級副總裁兼首席醫療官 Craig Granowitz 博士。今天下午早些時候，Lexicon 發布了一份新聞稿，宣布了我們 2023 年第一季度的財務業績，該新聞稿可在我們的網站 www.lexpharma.com 上以及通過我們向 SEC 提交的文件中獲取。我們的網站上提供了本次電話會議的網絡廣播以及幻燈片演示。在本次電話會議期間，我們將審查新聞稿中提供的信息，提供公司最新信息，然後利用剩餘時間回答您的問題。

Before we begin, let me remind you that we will be making forward-looking statements, including statements relating to the safety, efficacy, regulatory status and therapeutic and commercial potential of sotagliflozin, LX9211 and other drug candidates. These statements may include characterizations of the expected timing and results of clinical trials of sotagliflozin, LX9211 and our other drug candidates, and the regulatory status and market opportunity for those programs. This call may also contain forward-looking statements relating to our growth and future operating results, discovery and development of our drug candidates, launch and commercialization plans for any approved products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. Various risks may cause our actual results to differ materially from those expressed or implied in such forward-looking statements. These risks include uncertainties related to our NDA for sotagliflozin in heart failure and our discussions with the FDA regarding sotagliflozin, LX9211 and our other drug candidates, the success of our commercialization efforts with respect to any approved products, the timing and results of clinical trials and preclinical studies of sotagliflozin, LX9211 and our other drug candidates; our dependence upon strategic alliances and other third-party relationships; our ability to obtain patent protection for our discoveries; limitations imposed by patents owned or controlled by third parties and the requirements of substantial funding to conduct our planned research, development and commercialization activities. For a list and description of the risks and uncertainties that we face, please see the reports we have filed with the Securities and Exchange Commission.

在開始之前，請允許我提醒您，我們將做出前瞻性聲明，包括與 sotagliflozin、LX9211 和其他候選藥物的安全性、有效性、監管狀況以及治療和商業潛力相關的聲明。這些聲明可能包括 sotagliflozin、LX9211 和我們其他候選藥物臨床試驗的預期時間和結果的特徵，以及這些項目的監管狀況和市場機會。本次電話會議還可能包含與我們的增長和未來經營業績、候選藥物的發現和開發、任何已批准產品的上市和商業化計劃、戰略聯盟和知識產權以及其他非歷史事項有關的前瞻性陳述事實或信息。各種風險可能導致我們的實際結果與此類前瞻性陳述中明示或暗示的結果存在重大差異。這些風sotagliflozin、LX9211 和我們其他候選藥物的臨床前研究；我們對戰略聯盟和其他第三方關係的依賴；我們為我們的發現獲得專利保護的能力；第三方擁有或控制的專利所施加的限制以及進行我們計劃的研究、開發和商業化活動所需的大量資金的要求。有關我們面臨的風險和不確定性的列表和描述，請參閱我們向美國證券交易委員會提交的報告。

I would now like to turn the call over to Lonnel Coats.

我現在想把電話轉給 Lonnel Coats。

Thank you, Carrie. Good afternoon, everyone, and thank you for joining us on the call. First quarter of 2023 was another significant period for Lexicon as we continue to advance in both of our lead programs, sotagliflozin, our dual SGLT1/2 inhibitor that we're developing for heart failure, and LX9211, our AAK1 inhibitor that we're developing for neuropathic pain.

謝謝你，嘉莉。大家下午好，感謝您加入我們的電話會議。 2023 年第一季度對 Lexicon 來說是另一個重要時期，我們繼續推進兩個主導項目：sotagliflozin（我們正在開發的用於治療心力衰竭的雙重 SGLT1/2 抑製劑）和 LX9211（我們正在開發的 AAK1 抑製劑）用於神經性疼痛。

Starting with LX9211 program for neuropathic pain. As many of you know, we reported on the results of 2 Phase II proof-of-concept studies last year in diabetic peripheral neuropathic pain and postherpetic neuralgia. Bolstered by these results, we have continued to move forward with development plans for late-stage development and expect to have feedback from the FDA on these plans in the second quarter of this year.

從治療神經性疼痛的 LX9211 項目開始。正如你們許多人所知，我們去年報告了兩項關於糖尿病周圍神經病理性疼痛和帶狀皰疹後神經痛的 II 期概念驗證研究的結果。在這些結果的支持下，我們繼續推進後期開發的開發計劃，並預計在今年第二季度收到 FDA 對這些計劃的反饋。

Turning to sotagliflozin. As shared in our last quarterly call, we had our late cycle review meeting with FDA late February for our NDA for the treatment of heart failure. The agency indicated that there were no substantial review issues, and again, confirm that it has no plans to hold an advisory committee meeting. So we believe everything remains on track for our PDUFA target date on May 27.

轉向索格列淨。正如我們在上一季度電話會議中分享的那樣，我們在 2 月底與 FDA 召開了後期週期審查會議，討論我們治療心力衰竭的 NDA。該機構表示不存在實質性審查問題，並再次確認沒有計劃召開諮詢委員會會議。因此，我們相信一切都在按 5 月 27 日 PDUFA 目標日期進行。

Now since our last call, we also wanted to highlight the significant progress we have made across all functions of the company to be launch-ready for PDUFA, including, but not limited to, very productive label discussions and negotiations with the FDA, appropriate and preapproval information exchanges with payers across national and regional accounts, government and institutions, the recruitment of experienced cardiovascular sales professionals, of which the majority are already on board with the company. Presentations at 2 major medical meetings, including a feature presentation on the time to clinical benefit of sotagliflozin, which Dr. Granowitz will speak further about shortly. And finally, we finalized -- we're finalizing wholesaler and distribution agreements to be ready to ship product within the U.S. shortly following approval. We look forward to continuing to work with the FDA over the next few weeks during the review period and are planning to commercially launch sotagliflozin in the U.S. in the second quarter promptly following regulatory approval.

自從我們上次電話會議以來，我們還想強調我們在公司所有職能方面取得的重大進展，為 PDUFA 做好準備，包括但不限於非常富有成效的標籤討論以及與 FDA 的談判，適當和與國家和地區賬戶、政府和機構的付款人進行預先批准信息交流，招聘經驗豐富的心血管銷售專業人員，其中大多數已經加入公司。在兩次主要醫學會議上的演講，包括關於 sotagliflozin 臨床獲益時間的專題演講，Granowitz 博士將很快對此進行進一步討論。最後，我們正在敲定批發商和分銷協議，以便在獲得批准後不久就可以在美國境內運送產品。我們期待在未來幾週的審查期間繼續與 FDA 合作，併計劃在監管部門批准後立即在第二季度在美國商業化推出 sotagliflozin。

I will now turn the call over to Jeff to review the sotagliflozin program and to further review the status of our commercial launch preparations. Jeff?

我現在將電話轉給傑夫，以審查 sotagliflozin 計劃並進一步審查我們的商業上市準備工作的狀態。傑夫？

Thanks, Lonnel. There are nearly 7 million people in the United States living with heart failure, a number that is expected to increase to 8 million by 2030. Heart failure is the leading cause of hospitalization for Americans over 65, with approximately 1.3 million hospitalizations for heart failure annually. Patients who are hospitalized for heart failure are highly likely to return, with approximately 25% of patients being readmitted to the hospital within 30 days of discharge and 65% within 1 year.

謝謝，朗內爾。美國有近 700 萬人患有心力衰竭，預計到 2030 年這一數字將增加到 800 萬人。心力衰竭是 65 歲以上美國人住院的主要原因，每年約有 130 萬人因心力衰竭住院。因心力衰竭住院的患者很有可能返回醫院，大約 25% 的患者在出院後 30 天內再次入院，65% 的患者在 1 年內再次入院。

Hospital readmissions are burdensome not only for patients but also to the health care system. Annual costs from heart failure are expected to increase to nearly $70 billion by 2030, with 80% of those costs due to hospitalizations. There is a substantial unmet need for better treatment options for patients and, as these data make clear, a strong incentive for providers, hospitals and payers to identify new approaches to reduce hospital readmissions.

再入院不僅對患者而且對醫療保健系統來說都是負擔。到 2030 年，每年因心力衰竭造成的費用預計將增加到近 700 億美元，其中 80% 是住院費用。患者對更好的治療方案的需求尚未得到滿足，而且正如這些數據所表明的那樣，醫療服務提供者、醫院和付款人有強烈的動機去尋找減少再入院的新方法。

We also know that it is important to prioritize when patients are started on therapy in order to increase the likelihood that they remain on therapy following a hospitalization. As you can see from the data shown on this slide from the Journal of American College of Cardiology, starting patients on therapy at the time of hospital discharge results in significantly higher percentage of patients receiving appropriate treatment at 60 and 90 days and at 12 months follow-up.

我們還知道，重要的是要優先考慮患者何時開始接受治療，以增加他們在住院後繼續接受治療的可能性。正如您從《美國心髒病學會雜誌》這張幻燈片上顯示的數據中看到的那樣，在患者出院時開始接受治療會導致在 60 和 90 天以及 12 個月後接受適當治療的患者比例顯著提高-向上。

I will now turn the call over to Craig to discuss recent updates to the heart failure treatment guidelines and decision pathways prioritizing SGLT inhibitors and to review important data from 2 recent major scientific meetings, from the AHA meeting late last year regarding sotagliflozin's effects in reducing cardiovascular mortality and the risk of hospital readmissions at 30 and 90 days following discharge; and from the ACC meeting in March, regarding sotagliflozin's time to clinical benefit and consistent effects across left ventricular ejection fraction.

我現在將電話轉給克雷格，討論心力衰竭治療指南的最新更新和優先考慮 SGLT 抑製劑的決策途徑，並回顧最近兩次主要科學會議的重要數據，這些會議來自去年年底的 AHA 會議，涉及索格列淨在減少心血管疾病方面的作用出院後 30 天和 90 天的死亡率和再入院風險；以及 3 月份 ACC 會議上關於 sotagliflozin 實現臨床獲益的時間以及對左心室射血分數的一致影響的內容。

Thank you, Jeff. Heart failure is a multibillion-dollar market that is poised for substantial growth. Along with the increasing disease prevalence, this anticipated growth is being driven by new guidelines recently issued by major cardiovascular societies in the United States and Europe recommending the use of SGLT inhibitors as a pillar of care for treating heart failure.

謝謝你，傑夫。心力衰竭是一個價值數十億美元的市場，有望大幅增長。隨著疾病患病率的不斷增加，美國和歐洲主要心血管學會最近發布的新指南推動了這一預期的增長，該指南建議使用 SGLT 抑製劑作為治療心力衰竭的護理支柱。

In addition, just last week, ACC issued a new document in the April edition of JACC entitled 2023 ACC expert consensus decision pathway on the management of heart failure with preserved ejection fraction.

此外，就在上週，ACC在JACC 4月版上發布了一份新文件，題為《2023年ACC專家共識決策路徑關於射血分數保留的心力衰竭的管理》。

The consensus recommended that SGLT inhibitors should be initiated in all individuals with HFpEF lacking contraindications. Considered together with the previous consensus guidelines, the SGLT class is the only medical therapy recommended in all HF patients regardless of ejection fraction.

共識建議，所有沒有禁忌症的 HFpEF 患者都應開始使用 SGLT 抑製劑。與之前的共識指南一起考慮，無論射血分數如何，SGLT 類是所有心力衰竭患者唯一推薦的藥物治療。

It is also important to note that the SOLOIST worsening heart failure study of sotagliflozin in recently hospitalized patients resulted in significantly lower total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure than placebo regardless of left ventricular ejection fraction.

還值得注意的是，SOLOIST 對最近住院患者進行的 sotagliflozin 惡化心力衰竭研究顯示，無論左心室射血分數如何，與安慰劑相比，心血管原因死亡、住院和因心力衰竭緊急就診的總人數顯著降低。

Currently, of those 1.3 million hospitalizations a year due to heart failure, data suggest that fewer than 10% of these patients are currently discharged with a prescription for an SGLT inhibitor. This provides an exceptional opportunity for sotagliflozin given its unique data showing its significant impact on that transition of care patient population.

目前，在每年因心力衰竭住院的 130 萬人中，數據顯示，其中只有不到 10% 目前出院時持有 SGLT 抑製劑處方。鑑於 sotagliflozin 獨特的數據顯示其對護理患者群體的轉變具有重大影響，這為 sotagliflozin 提供了絕佳的機會。

Turning to the next slide. As you can see, this group of patients from the SOLOIST trial, while improving in their clinical journey, remains at risk for future heart failure events, as Jeff has noted in prior slides. As a reminder, the SOLOIST trial enrolled approximately 1,200 patients who have been hospitalized for heart failure and were transitioning out of the hospital. Double-blind randomized treatment began either in the hospital or within 3 days following their discharge. There were approximately 50% of patients in each of those 2 categories.

轉到下一張幻燈片。正如您所看到的，正如傑夫在之前的幻燈片中指出的那樣，SOLOIST 試驗中的這組患者雖然在臨床歷程中有所改善，但仍然面臨未來發生心力衰竭事件的風險。提醒一下，SOLOIST 試驗招募了大約 1,200 名因心力衰竭住院並正在出院的患者。雙盲隨機治療在醫院內或出院後 3 天內開始。這 2 類中每一類都有大約 50% 的患者。

As you can see in this slide, and as a reminder, the primary endpoint of the trial was achieved with a statistically significant and clinically meaningful reduction of 33% in the composite total cardiovascular death, hospitalization for heart failure and urgent heart failure visits with the need to treat only 4 patients for 1 year to avoid 1 endpoint event, a finding which is unsurpassed within the SGLT inhibitor class.

正如您在這張幻燈片中所看到的，提醒一下，該試驗的主要終點是通過以下方式實現的：在統計上顯著且具有臨床意義的複合總心血管死亡、心力衰竭住院和緊急心力衰竭就診率降低了 33%。一年內僅需治療 4 名患者即可避免 1 次終點事件，這一發現在 SGLT 抑製劑類別中是無與倫比的。

The objective of the post hoc analysis presented by Dr. Bert Pitt at last year's American Heart Association Scientific Sessions was to evaluate the efficacy of sotagliflozin versus placebo at reducing hospital readmissions and mortality within 30 and 90 days after discharge from a heart failure hospitalization among the patients who began study treatment on or before the date of discharge. As a reminder, there were no differences between these 2 groups of patients for baseline characteristics or the primary endpoint.

Bert Pitt 博士在去年的美國心臟協會科學會議上提出的事後分析的目的是評估 sotagliflozin 與安慰劑相比，在心力衰竭住院出院後 30 至 90 天內減少再入院和死亡率方面的功效。在出院之日或之前開始研究治療的患者。提醒一下，這兩組患者的基線特徵或主要終點沒有差異。

Presented here are the results for cardiovascular death and heart failure-related events for 30 and 90 days post discharge. You can see the sotagliflozin arm in blue begins to separate from placebo arm in red very early on and showed the treatment with sotagliflozin resulted in a statistically relative risk reduction versus placebo of approximately 50% for readmission for nonfatal heart failure events and for the composite of cardiovascular death and readmission for heart failure at both 30 and 90 days following hospital discharge.

這裡展示的是出院後 30 天和 90 天的心血管死亡和心力衰竭相關事件的結果。您可以看到藍色的 sotagliflozin 組很早就開始與紅色的安慰劑組分開，並且顯示 sotagliflozin 治療與安慰劑相比，在統計上相對風險降低了大約 50%，其中非致命性心力衰竭事件的再入院和綜合風險出院後 30 和 90 天的心血管死亡和因心力衰竭再次入院的情況。

These findings are unique. They also underscore the benefit of early initiation of evidence-based heart failure therapy. Sotagliflozin is the first compound to demonstrate a reduction on both mortality and heart failure events for treatment initiated during a heart failure hospitalization.

這些發現是獨一無二的。他們還強調了早期開始循證心力衰竭治療的好處。 Sotagliflozin 是第一個證明在心力衰竭住院期間開始治療可降低死亡率和心力衰竭事件的化合物。

Finally, we wanted to highlight key data just presented at the American College of Cardiology 72nd Annual Scientific Session held in March of 2023 on the time to clinical benefit of sotagliflozin, which has also been published in the Journal of the American College of Cardiology shortly thereafter. The study authors concluded that treatment with sotagliflozin led to a statistically significant reduction in the risk of the primary outcome by day 27 post randomization. These results were consistent across the left ventricular ejection fraction range, a finding that aligns with the recent ACC consensus statement that was just recently referenced.

最後，我們想強調一下剛剛在 2023 年 3 月舉行的美國心髒病學會第 72 屆年度科學會議上公佈的有關 sotagliflozin 臨床獲益時間的關鍵數據，該數據不久後也發表在《美國心髒病學會雜誌》上。研究作者得出結論，到隨機分組後第 27 天，使用 sotagliflozin 治療可顯著降低主要結局的風險。這些結果在左心室射血分數範圍內是一致的，這一發現與最近引用的 ACC 共識聲明一致。

We believe that these data support and further extend the 30-day reduction in readmission results for sotagliflozin presented at the 2022 AHA Meeting that treatment with sotagliflozin results in an early and significant reduction in heart failure events and cardiovascular death in the high-cost, high-risk recently hospitalized patients with worsening heart failure.

我們相信，這些數據支持並進一步延長了 2022 年 AHA 會議上提出的 sotagliflozin 再入院 30 天減少結果，即 sotagliflozin 治療可早期顯著減少高成本、高成本的心力衰竭事件和心血管死亡。 -最近住院的患者心力衰竭惡化的風險。

I'll now turn the call back over to Jeff to share more about our commercial launch preparations.

現在我將把電話轉回傑夫，分享更多有關我們商業發布準備工作的信息。

Thank you, Craig. As Lonnel referenced earlier, commercial launch preparations for sotagliflozin have been underway for well over a year and have progressed meaningfully throughout Q1. We have invested significantly in the infrastructure to support a commercial launch in heart failure in the U.S. in the first half of 2023, and we have the required resources currently in place. This includes the full market access and medical teams who have been having the appropriate preapproval information exchanges with key stakeholders since late last year.

謝謝你，克雷格。正如 Lonnel 之前提到的，sotagliflozin 的商業上市準備工作已經進行了一年多，並且在整個第一季度取得了有意義的進展。我們在基礎設施方面投入了大量資金，以支持 2023 年上半年在美國進行心力衰竭的商業啟動，並且我們目前擁有所需的資源。這包括全面的市場准入和醫療團隊，他們自去年年底以來一直與主要利益相關者進行適當的批准前信息交流。

As we noted last quarter, we brought on our sales leadership team towards the end of last year. As of today, we have filled the majority of the sales representative positions to be ready for deployment following approval. Further, we have substantially completed contracting with the major wholesaler and distribution networks in the U.S., and we are well prepared to deploy comprehensive patient support programs to provide appropriate assistance when needed as we ramp up our access during launch. Based on all the foundational work done to date, we feel confident that we have the right talent and resources to be ready for a very successful commercial launch following regulatory approval in the coming weeks.

正如我們上季度指出的那樣，我們在去年年底引入了銷售領導團隊。截至今天，我們已經填補了大部分銷售代表職位，準備在批准後進行部署。此外，我們已基本完成與美國主要批發商和分銷網絡的合同，並且我們已做好充分準備，部署全面的患者支持計劃，以便在啟動期間增加訪問範圍時在需要時提供適當的幫助。基於迄今為止完成的所有基礎工作，我們相信我們擁有合適的人才和資源，可以在未來幾週獲得監管部門批准後為非常成功的商業發布做好準備。

To summarize, we believe we have a tremendous opportunity for sotagliflozin bolstered by 3 key factors: one, updated heart failure treatment guidelines; two, a growing unmet medical need with SGLT adoption still in the early part of the adoption curve; and three, a unique data set for sotagliflozin specifically addressing the effectiveness in patients hospitalized for heart failure. Capitalizing on those 3 factors, we are making launch preparations with a focused commercial strategy using targeted messaging based on areas of clinical differentiation and where our value proposition is expected to have the most impact, including with cardiologists and hospital systems and payers that bear the cost of hospitalizations and rehospitalizations.

總而言之，我們相信 sotagliflozin 擁有巨大的機會，這得益於 3 個關鍵因素：一是更新的心力衰竭治療指南；第二，日益增長的未滿足的醫療需求，SGLT 的採用仍處於採用曲線的早期階段；第三，sotagliflozin 的獨特數據集，專門針對因心力衰竭住院患者的有效性。利用這三個因素，我們正在根據臨床差異化領域以及我們的價值主張預計會產生最大影響的領域（包括心髒病專家、醫院系統和承擔費用的付款人）使用有針對性的信息，通過有針對性的商業策略來進行啟動準備住院和再住院。

We will now turn briefly to our LX9211 program. LX9211 is a potent, highly selective small molecule inhibitor of a novel target adapter-associated kinase 1, or AAK1. In a number of relevant animal models of neuropathic pain, LX9211 has demonstrated consistent, significant reductions in pain scores, even when compared to positive controls such as gabapentin.

現在我們將簡要介紹一下 LX9211 程序。 LX9211 是一種新型靶標接頭相關激酶 1（AAK1）的有效、高選擇性小分子抑製劑。在許多相關的神經性疼痛動物模型中，即使與加巴噴丁等陽性對照相比，LX9211 也能持續顯著降低疼痛評分。

LX9211 achieves high levels of drug in the CNS, and importantly the mechanism of action of LX9211 is independent of the opioid pathway. In Phase I studies, LX9211 was shown to be well tolerated with a pharmacokinetic profile supportive of once-daily dosing. Lexicon has been granted Fast Track Designation by the FDA for diabetic peripheral neuropathic pain.

LX9211 在 CNS 中實現了高水平的藥物，重要的是 LX9211 的作用機制獨立於阿片類藥物途徑。在 I 期研究中，LX9211 被證明具有良好的耐受性，其藥代動力學特徵支持每日一次給藥。 Lexicon 已獲得 FDA 授予的治療糖尿病周圍神經病理性疼痛的快速通道資格。

From a market perspective, the neuropathic pain market is expected to grow by more than 13% worldwide between 2020 and 2026, and is projected to be worth more than $13.2 billion. Currently, available therapies are limited by a lack of efficacy, side effects and potential for abuse. As a result, there's a tremendous opportunity for new and innovative treatments such as LX9211 to enter this growing market with a great unmet need.

從市場角度來看，2020年至2026年間，全球神經病理性疼痛市場預計將增長13%以上，預計價值將超過132億美元。目前，可用的療法因缺乏療效、副作用和濫用的可能性而受到限制。因此，LX9211 等新型創新療法有巨大的機會進入這個需求未得到滿足的不斷增長的市場。

I will now turn the call back to Craig to briefly review the key results from our Phase II studies in 2 distinct types of neuropathic pain that read out last year.

現在，我將把電話轉回克雷格，簡要回顧一下去年宣讀的針對兩種不同類型的神經性疼痛的 II 期研究的主要結果。

Thank you, Jeff. As we discussed during our last quarterly call, the primary endpoint of the RELIEF-DPN-1 study was achieved, with a statistically significant reduction in the average daily pain score, or ADPS, at week 6 compared to placebo in the low-dose arm. There was an absolute reduction in ADPS from baseline of 1.39 points, with a p-value of 0.007 compared to placebo. High dose arm achieved a reduction from baseline of 1.27 points with a p-value of 0.03 compared to placebo, narrowly missing a significant threshold in the study of 0.028 but showing consistent effects.

謝謝你，傑夫。正如我們在上一季度電話會議中討論的那樣，RELIEF-DPN-1 研究的主要終點已經實現，與低劑量組中的安慰劑相比，第 6 週的平均每日疼痛評分 (ADPS) 有統計學上的顯著降低。與安慰劑相比，ADPS 相對於基線絕對降低了 1.39 點，p 值為 0.007。與安慰劑相比，高劑量組較基線降低了 1.27 個點，p 值為 0.03，略低於研究中的顯著閾值 0.028，但顯示出一致的效果。

We also noted during the blinded 5-week placebo runoff period, there was a gradual tapering of efficacy in both treatment arms with no evidence of rebound pain or withdrawal symptoms. There were no observed differences in treatment-emergent adverse events between the treatment and placebo arms during the runoff period and no drug-related serious adverse events or deaths were reported in the trial.

我們還注意到，在為期 5 週的盲法安慰劑試驗期間，兩個治療組的療效逐漸減弱，沒有證據表明出現反跳痛或戒斷症狀。在試驗期間，治療組和安慰劑組之間在治療引起的不良事件方面沒有觀察到差異，並且試驗中沒有報告與藥物相關的嚴重不良事件或死亡。

As we also discussed in our last quarterly call, our second Phase II proof-of-concept study in postherpetic neuralgia, RELIEF-PHN-1, LX9211 achieved a reduction in the average daily pain score of 2.42 points from baseline at week 6 compared to a reduction of 1.62 points in the placebo arm with a placebo-adjusted difference of 0.8 points and a p-value of 0.12. Though these results did not achieve statistical significance on the primary endpoint of the study, overall results demonstrated clear evidence of effect and achieved our goal for this small 79-patient study to support the further development of LX9211 and another neuropathic pain condition.

正如我們在上一季度電話會議中還討論的那樣，我們針對帶狀皰疹後神經痛的第二項 II 期概念驗證研究 RELIEF-PHN-1、LX9211 與對照組相比，在第 6 週時平均每日疼痛評分較基線降低了 2.42 分。安慰劑組降低了 1.62 分，安慰劑調整後的差異為 0.8 分，p 值為 0.12。儘管這些結果在研究的主要終點上沒有達到統計學顯著性，但總體結果顯示了明確的效果證據，並實現了我們在這項 79 名患者參與的小型研究中的目標，即支持 LX9211 和另一種神經性疼痛疾病的進一步開發。

The results of the RELIEF-PHN-1 trial were recently presented at the Emerging Science section of the American Academy of Neurology Annual Meeting on April 24th of this year, and will also be presented at the British Pain Society 56th Annual Scientific Meeting taking place in Glasgow from May 9 to May 11.

RELIEF-PHN-1 試驗的結果最近在今年 4 月 24 日舉行的美國神經病學學會年會新興科學部分公佈，並將在 2017 年舉行的英國疼痛學會第 56 屆年度科學會議上公佈。格拉斯哥 5 月 9 日至 11 日。

Notably, as you can see on the slide, LX9211 has shown consistent results across these 2 studies. When placing the graphs from the 2 studies side-by-side, the separation from placebo and the mean change from baseline create the same shaped curves.

值得注意的是，正如您在幻燈片上看到的，LX9211 在這兩項研究中顯示出一致的結果。當並排放置兩項研究的圖表時，與安慰劑的分離和與基線的平均變化創建了相同形狀的曲線。

In conclusion, we have now completed 2 Phase II proof-of-concept studies of LX9211 that support AAK1 inhibition as a potential new mechanism of action for treating neuropathic pain. We believe that LX9211 has the potential to overcome many of the shortcomings of current therapies and could be a welcome new innovation for those suffering from neuropathic pain on a daily basis. This is a large and growing market with a high unmet medical need.

總之，我們現已完成 LX9211 的 2 項 II 期概念驗證研究，支持 AAK1 抑製作為治療神經性疼痛的潛在新作用機制。我們相信 LX9211 有潛力克服當前療法的許多缺點，並且對於那些每天遭受神經性疼痛的人來說可能是一個受歡迎的新創新。這是一個巨大且不斷增長的市場，醫療需求尚未得到滿足。

As a result, we are pursuing the rapid advancement of LX9211 into the late-stage development for the treatment of neuropathic pain. We are continuing the work to identify and optimize proper dosing regimens, and we are preparing to receive feedback from the FDA in Q2 on how best to advance the program into late-stage development as quickly and as efficiently as possible.

因此，我們正在努力將 LX9211 快速推進到治療神經性疼痛的後期開發階段。我們正在繼續努力確定和優化適當的給藥方案，並準備在第二季度收到 FDA 的反饋，了解如何盡可能快速有效地將項目推進到後期開發。

I'd now like to turn the call back to Jeff to take us through the financial results for the first quarter 2023.

我現在想把電話轉回給 Jeff，讓他向我們介紹 2023 年第一季度的財務業績。

Thank you, Craig. I will review some key aspects of our first quarter 2023 financial results. More financial details can be found in the press release that we issued earlier today and our 10-Q that will be filed shortly with the SEC.

謝謝你，克雷格。我將回顧 2023 年第一季度財務業績的一些關鍵方面。更多財務細節可以在我們今天早些時候發布的新聞稿以及即將向 SEC 提交的 10-Q 中找到。

We ended the quarter with $105.9 million in cash and investments. We believe that our existing capital resources provide us with the right level of funding to support continued commercial preparations and make appropriate investments in research and clinical development. Our loan facility with Oxford Finance, which provides up to $100 million in additional borrowing capacity, gives us substantial financial flexibility as we prepare to embark upon the expected launch of sotagliflozin in the second quarter of this year.

本季度結束時，我們擁有 1.059 億美元的現金和投資。我們相信，我們現有的資本資源為我們提供了適當水平的資金，以支持持續的商業準備並對研究和臨床開發進行適當的投資。我們與牛津金融公司的貸款安排提供了高達 1 億美元的額外借款能力，為我們準備在今年第二季度推出預計的 sotagliflozin 提供了巨大的財務靈活性。

We just recently executed an amendment with Oxford that allows us to draw up to $75 million upon approval of sotagliflozin, the proceeds of which we would use to further fund our planned launch. We anticipate that our existing cash and investments, together with capacity under the loan facility will provide us with sufficient resources to manage our operations well into the anticipated launch of sotagliflozin into the market.

我們最近剛剛與牛津大學簽署了一項修正案，允許我們在 sotagliflozin 獲得批准後提取最多 7500 萬美元，我們將用這筆資金進一步資助我們計劃的上市。我們預計，我們現有的現金和投資以及貸款安排下的產能將為我們提供足夠的資源來管理我們的運營，以應對預計將 sotagliflozin 推向市場的情況。

As indicated in our press release this afternoon, we had minimal revenues for the first quarters of both 2023 and 2022. Research and development expenses for the first quarter of 2023 decreased to $12.1 million from $14.9 million for the corresponding period in 2022, primarily due to lower external research and development costs and professional and consulting fees in 2023. Selling, general and administrative expenses for the first quarter of 2023 increased to $19.5 million from $8.5 million for the corresponding period in 2022. This was primarily due to increases in headcount and in professional and consulting fees relating to preparations for the commercial launch of sotagliflozin in heart failure.

正如我們今天下午的新聞稿所示，我們 2023 年和 2022 年第一季度的收入都很低。2023 年第一季度的研發費用從 2022 年同期的 1,490 萬美元減少到 1,210 萬美元，主要是由於2023 年外部研發成本以及專業和諮詢費用降低。2023 年第一季度的銷售、一般和管理費用從 2022 年同期的 850 萬美元增加到 1,950 萬美元。這主要是由於員工人數的增加和與準備用於心力衰竭的 sotagliflozin 商業上市有關的專業和諮詢費用。

In total, net loss for the first quarter of 2023 was $32.3 million or $0.17 per share as compared to a net loss of $23.5 million or $0.16 per share in the corresponding period in 2022. For the first quarters of 2023 and 2022, net loss included noncash stock-based compensation expense of $3.4 million and $2.8 million, respectively.

總體而言，2023 年第一季度的淨虧損為 3230 萬美元，即每股 0.17 美元，而 2022 年同期的淨虧損為 2350 萬美元，即每股 0.16 美元。2023 年和 2022 年第一季度的淨虧損包括非現金股票補償費用分別為 340 萬美元和 280 萬美元。

Before we transition to Q&A, I'd like to take this opportunity to reiterate the great progress we have made since our last call in preparation for the launch of sotagliflozin into the heart failure market. Across every function of the company, we have made considerable progress to prepare for our PDUFA date of May 27th and, if approved, a prompt launch into the market in Q2 2023.

在我們進入問答環節之前，我想藉此機會重申自上次電話會議以來我們在準備將 sotagliflozin 推向心力衰竭市場方面所取得的巨大進展。在公司的各個職能部門，我們都在為 5 月 27 日的 PDUFA 日期做準備方面取得了相當大的進展，如果獲得批准，我們將在 2023 年第二季度立即進入市場。

I would like to pause now and ask the operator to open up the call to take your questions.

我現在想暫停一下，請接線員接通電話，回答您的問題。

(Operator Instructions) Our first question today comes from Andrew Tsai from Jefferies.

（操作員說明）我們今天的第一個問題來自 Jefferies 的 Andrew Tsai。

So the first one is I noticed in your prepared remarks, it sounded like you're in very productive labeling discussions. So if or when sota does get approved, is there anything in the label that you would encourage investors to pay attention to? And maybe talk about, if you can, what we can expect to see on the front page label claim?

第一個問題是我在您準備好的發言中註意到，聽起來您正在進行非常富有成效的標籤討論。那麼，如果 sota 確實獲得批准，您會鼓勵投資者關注標籤中的任何內容嗎？如果可以的話，也許可以談談我們期望在首頁標籤聲明上看到什麼？

Great question, Andrew. Yes, I think you've characterized it correctly. We've had some outstanding conversations with the FDA. I think what you can expect is we've made a pretty powerful argument that this drug works for heart failure. This will be a cardiovascular drug and nothing else, meaning that we believe that the drug will work across heart failure regardless of diabetes. And therefore, what you should expect is a broad label for the drug.

好問題，安德魯。是的，我認為你對它的描述是正確的。我們與 FDA 進行了一些精彩的對話。我想你可以期待的是我們已經提出了一個非常有力的論據，即這種藥物對心力衰竭有效。這將是一種心血管藥物，而不是其他藥物，這意味著我們相信，無論糖尿病如何，該藥物都可以治療心力衰竭。因此，您應該期待的是該藥物的廣泛標籤。

As Craig has mentioned very clearly during this call, sotagliflozin works across left ventricular ejection fraction, including HFpEF. You should expect us to move in that direction as well. And so I think those are the 2 broad perspectives, I would say, investors should look for when we turn the cards over and finish our negotiations with the agency.

正如克雷格在這次電話會議中非常清楚地提到的那樣，索格列淨對左心室射血分數起作用，包括 HFpEF。您應該期望我們也會朝這個方向前進。因此，我認為，當我們翻牌並完成與該機構的談判時，投資者應該關注這兩個廣泛的觀點。

And so let's just say it does get approved, first, do you think there is a low-hanging fruit of patients that your, I believe, 100 sales reps can tackle right off the bat? And then secondly is, what would you say for -- as we think about 2023 and 2024, what would be the key drivers for sales to accelerate? What needs basically to be done to ensure a robust uptake?

因此，我們只能說它確實獲得了批准，首先，您是否認為有一個唾手可得的患者果實，我相信您的 100 名銷售代表可以立即解決？其次，您認為，當我們考慮 2023 年和 2024 年時，銷售加速的關鍵驅動因素是什麼？為了確保強勁的採用，基本上需要做什麼？

Yes, 2 things. One is that given that 90% of the market is still absent SGLTs regardless of the guidelines, so I think that's a huge low-hanging fruit for us to try to achieve.

是的，有兩件事。一是考慮到無論指導方針如何，90% 的市場仍然缺乏 SGLT，所以我認為這是我們需要努力實現的一個巨大的、容易實現的目標。

The place we're going to focus is not in the broader area of cardiovascular competition in heart failure. It's really going to be in that transition of care, a patient that's inside the hospital. That's where we have very unique data. And I think that is our opportunity to not only have impact on patient, but also have impact on systems and bringing costs down. And therefore, we will spend most of our time to do that.

我們要關注的地方不是心力衰竭的心血管競爭這一更廣泛的領域。這實際上是在護理的轉變中，一個病人在醫院裡。這就是我們擁有非常獨特的數據的地方。我認為這是我們的機會，不僅可以對患者產生影響，而且可以對系統產生影響並降低成本。因此，我們將花費大部分時間來做這件事。

In 2023, it will be less about how much net sales you move, it will be more about how well we're able to penetrate the IDNs, how well we're able to penetrate into Medicare and get coverage. And so we've been out in markets and appropriate conversations, trying to lock and load and get ready for that. And so we're going to lay out for you when we get approval is what are the metrics that you should really look for. Number one will be our ability to penetrate and get coverage in 2023. We do that well. 2024 will be all about net trade sales at that time.

到 2023 年，我們將不再關注淨銷售額的變化，而更多地關注我們滲透 IDN 的能力、滲透到 Medicare 並獲得保險的能力。因此，我們已經進入市場並進行了適當的對話，試圖鎖定並加載並為此做好準備。因此，當我們獲得批准時，我們將為您列出您真正應該尋找的指標是什麼。第一個是我們在 2023 年滲透和覆蓋的能力。我們在這方面做得很好。 2024 年將主要關注淨貿易銷售。

And last one is, will IQVIA sales be trackable or the scripts?

最後一個問題是，IQVIA 的銷售情況或腳本是否可以追踪？

Jeff, I'll turn it over to you.

傑夫，我把它交給你了。

We expect that IQVIA will be able to track sales in terms of the scripts. But again, a lot of this is what we're going to be focused on is going to be in terms of what we talk about. We'll be talking about getting access and getting formulary coverage.

我們預計 IQVIA 將能夠跟踪腳本的銷售情況。但同樣，我們將重點關注其中的很多內容。我們將討論獲得訪問權和獲得處方保險。

Our next question comes from Yigal Nochomovitz from Citigroup.

我們的下一個問題來自花旗集團的 Yigal Nochomovitz。

On 9211, I'm just curious, you mentioned you're going to have feedback from the FDA in this quarter on the path forward. Could you talk a little bit more about what you expect there? Have you proposed a specific Phase III plan for both indications? What additional validation or clearance that you're expecting from the FDA with regard to those 2 diseases? And also regarding partnering, I know you've talked about partnering this in the past. Can you just give us an update there on how that's going?

關於 9211，我只是很好奇，您提到您將在本季度收到 FDA 關於前進道路的反饋。您能多談談您對那裡的期望嗎？您是否針對這兩種適應症提出了具體的 III 期計劃？您期望 FDA 對這兩種疾病進行哪些額外的驗證或許可？關於合作，我知道您過去曾談論過合作。您能給我們介紹一下進展情況嗎？

Okay. Great questions, Yigal. Let me turn it over to Jeff.

好的。很好的問題，伊格爾。讓我把它交給傑夫。

We are outlining with FDA the key elements of the plan going forward into late-stage development. And it's mostly focused on the largest of these indications, which is diabetic peripheral neuropathic pain and other work that we need to do to advance the program going forward. So that's really been the area of focus.

我們正在與 FDA 概述該計劃進入後期開發的關鍵要素。它主要關注其中最大的適應症，即糖尿病周圍神經病理性疼痛以及我們需要做的其他工作來推進該計劃。所以這確實是重點領域。

And we -- in addition to that, we're continuing dialogue with potential partners, and we'll be proceeding with those discussions as we get further into the development. But in the meantime, we are continuing to take steps to push this forward into development and we're committed to doing that going forward. And we'll do that with the feedback that we get from the agency later this quarter.

除此之外，我們正在繼續與潛在合作夥伴進行對話，隨著我們進一步開發，我們將繼續進行這些討論。但與此同時，我們正在繼續採取措施推動其發展，並且我們致力於繼續這樣做。我們將根據本季度晚些時候從該機構獲得的反饋來做到這一點。

So you would wait for a partner for starting a Phase III or not necessarily? You might go ahead yourself.

那麼您會等待合作夥伴開始第三階段，還是不一定？你可以自己繼續。

We are pushing forward with the development and doing the work to push forward in development and advancing that. And frankly, we believe that the way to create the greatest value in partnership is to continue to develop the drug and to push it forward in development.

我們正在推動發展，並致力於推動發展並推進發展。坦白說，我們認為，在合作中創造最大價值的方法是繼續開發藥物並推動其發展。

Okay. But you're focusing on DPN? Yes.

好的。但您專注於 DPN？是的。

Yes, Yigal, I think for us, DPN is the biggest opportunity. And to Jeff's point, we're not going to -- we shouldn't wait for a partner. We'd be waiting forever trying to negotiate the proper value I think we can achieve with this program. The best way to do this is to get the FDA feedback, make sure that we're aligned around that feedback and keep developing the program forward so that we can be in the best position to achieve the value we think this drug will have going forward. So DPN will be our focus.

是的，Yigal，我認為對我們來說，DPN 是最大的機會。對於傑夫來說，我們不會——我們不應該等待合作夥伴。我們將永遠等待，試圖協商我認為我們可以通過該計劃實現的適當價值。做到這一點的最佳方法是獲得 FDA 的反饋，確保我們圍繞這些反饋保持一致，並繼續向前發展該計劃，以便我們能夠處於最佳位置，實現我們認為該藥物未來將具有的價值。所以DPN將是我們的重點。

I think what a partnership really provides for us if we should achieve that is it allows us to go broader than DPN. It allow us to go beyond DPN to PHN, which is why we did that work and pursue a broader neuropathic pain indication. But in the absence of that, Lexicon can advance this compound for DPN, which is what is our current goal.

我認為，如果我們要實現這一目標，合作夥伴關係真正為我們提供的就是它讓我們能夠走得比 DPN 更廣泛。它使我們能夠超越 DPN 到 PHN，這就是我們開展這項工作並追求更廣泛的神經病理性疼痛適應症的原因。但如果沒有的話，Lexicon 可以為 DPN 推進這種化合物，這就是我們當前的目標。

Okay. Great. And then on heart failure, so obviously a big day coming up in the, I guess, 25 days. So I wanted to drill down a little bit into the slice of the market, this transition of care in the recently worsening heart failure. I just want to get a better understanding. I mean how much of a white space is this in terms of entrenched competitors? What are you hearing from the channel checks as far -- are SGLTs being used off label here? Or is this really an area where you're just going to come in and be able to take share quickly given the unique value proposition that you've outlined both with the guidelines as well as with the strong data at AHA? And what's been the -- you mentioned some early discussions, as you said, with the IDNs and the reimbursement in the Medicare and so on. What's been the receptivity so far in terms of the value proposition to covering this and filling this gap in the treatment channel that you've talked about?

好的。偉大的。然後是心力衰竭，我猜，25 天后顯然是一個重要的日子。因此，我想深入了解市場的一部分，即最近惡化的心力衰竭的護理轉變。我只是想得到更好的理解。我的意思是，對於根深蒂固的競爭對手來說，這有多少空白？到目前為止，您從渠道檢查中聽到了什麼——SGLT 是否在標籤外使用？或者，鑑於您通過指南以及 AHA 的強大數據概述的獨特價值主張，這真的是您即將進入並能夠快速分享的領域嗎？正如您所說，您提到了與 IDN 和醫療保險報銷等方面的一些早期討論。到目前為止，就涵蓋這一問題並填補您所討論的治療渠道中的這一空白的價值主張而言，接受度如何？

So to answer the first part of your question, SGLT inhibitors are starting to be used in the hospital setting. And it's variable among institutions as to how widely they're being used. But we're still, at this point, early in the adoption curve for use of SGLT inhibitors for that transition of care patients. And most of the argument for it has been that it's better to get people on therapy at hospital or upon discharge because they're likely to stay on therapy if that happens. We're going to bring our unique data that shows benefits on hard end points into that setting. And that's what we're going to leverage as we proceed with the commercial launch of sotagliflozin as our area of focus. But it's already starting to pick up in that area.

因此，回答你問題的第一部分，SGLT 抑製劑已開始在醫院環境中使用。各個機構的使用範圍也各不相同。但目前我們仍處於使用 SGLT 抑製劑治療患者過渡的早期階段。大多數觀點認為，最好讓人們在醫院或出院後接受治療，因為如果發生這種情況，他們很可能會繼續接受治療。我們將把顯示硬端點優勢的獨特數據帶入該設置。這就是我們在將 sotagliflozin 商業化作為我們的重點領域時將要利用的。但該地區的情況已經開始好轉。

The second part of the question was receptivity among payers and hospital systems. I would say -- I would characterize that receptivity as being very encouraging. We have a unique value proposition there. We will be publishing data about cost effectiveness and be talking about the value that we bring. But the unique data from SOLOIST has a benefit that uniquely is important to hospital systems and to payers as we think about the people who are really bearing those costs of that rehospitalization and the proof that we have from the studies that we ran, and from SOLOIST in particular, that shows this benefit in hospital readmissions and not only overall, but also the 30- and 90-day hospital readmission data that were presented to AHA last year. So that value proposition, what we can bring to the table from an economic perspective for payers and hospital systems has been resonating very well.

問題的第二部分是付款人和醫院系統的接受度。我想說——我認為這種接受能力是非常令人鼓舞的。我們在那裡有獨特的價值主張。我們將發布有關成本效益的數據，並討論我們帶來的價值。但是，SOLOIST 的獨特數據具有對醫院系統和付款人特別重要的好處，因為我們會考慮真正承擔再住院費用的人，以及我們從我們進行的研究和 SOLOIST 中獲得的證據。特別是，這不僅顯示了重新入院的好處，而且不僅顯示了總體的好處，還顯示了去年向 AHA 提交的 30 天和 90 天的重新入院數據。因此，我們從經濟角度為付款人和醫院系統提供的價值主張引起了很好的共鳴。

I'll just add a couple of other points to what Jeff was saying. I think it's important to put in context how recent these guideline changes are. That the first guidelines, that were the European guidelines, only came out less than 2 years ago. The U.S. combined guidelines around use of SGLT inhibitors at all really only came out 1.5 years ago. And this consensus statement in the HFpEF category only came out last week.

我將在傑夫所說的基礎上添加其他幾點。我認為重要的是要了解這些指南變化的最新情況。第一個指南，即歐洲指南，不到兩年前才發布。美國關於 SGLT 抑製劑使用的綜合指南實際上只是在 1.5 年前發布。而這份 HFpEF 類別的共識聲明上週才出來。

I think when you think about the fact, as Jeff mentioned, the penetration of SGLT inhibitors is less than 10% currently, and if you think about beta blockers being at 90% and the fact that the SGLT class now is the only class of agents that's now recommended at a 1A level of recommendation across the entire class of HFrEF and HFpEF, I think the opportunity set for the SGLT inhibitors as a class is quite profound and a huge tailwind at our back.

我想，正如傑夫提到的，SGLT 抑製劑的滲透率目前還不到 10%，而 β 受體阻滯劑的滲透率為 90%，並且 SGLT 類藥物現在是唯一一類藥物。現在，整個 HFrEF 和 HFpEF 類別的推薦級別為 1A，我認為 SGLT 抑製劑作為一類抑製劑的機會是相當深遠的，是我們背後的巨大推動力。

I think on top of that, the value proposition with sotagliflozin in that transition of care patient, which is the highest unmet need, 25% of these patients coming back to the hospital in 30 days, 65% within a year, 100 events per 100 patient years in that group of patients. The payers all know there's a problem there, and our data set is unparalleled. There is no other SGLT that can present a data set like ours in that group of patients. So we think that there is a really strong class rationale, market need and attributes of sotagliflozin as a new agent that support its uptake in use.

我認為最重要的是，sotagliflozin 在護理患者過渡中的價值主張，這是未滿足的最高需求，這些患者中有 25% 在 30 天內返回醫院，65% 在一年內，每 100 人中有 100 起事件該組患者的患者年數。付款人都知道那裡存在問題，而我們的數據集是無與倫比的。沒有其他 SGLT 可以在該組患者中提供像我們這樣的數據集。因此，我們認為 sotagliflozin 作為一種新藥物有非常強大的類別理由、市場需求和屬性，支持其使用。

The only thing I would add, and I think my colleagues have been very clear, is in that class, there's only 3 SGLTs that's going to be in this classified in this fight. We know Jardiance is one, and the other one certainly would be dapagliflozin. And the third one will be sotagliflozin. Why is that unique is that in the European guidelines, we were spoken about, and we hadn't even submitted the drug. That's how powerful the data is.

我唯一要補充的是，我認為我的同事們已經非常清楚了，在該級別中，只有 3 名 SGLT 會在這場戰鬥中被歸為此類。我們知道 Jardiance 是其中之一，另一種肯定是達格列淨。第三種是索格列淨。其獨特之處在於，在歐洲指南中，我們被談論了，但我們甚至沒有提交該藥物。可見數據的力量有多大。

We get to the U.S. guidelines, once again, there is a specificity to sotagliflozin, and we hadn't received an approval. And so already sotagliflozin and the uniqueness of this data is falling into these guidelines absent the drug even being approved. And so we will have these guidelines and a way of these guidelines pretty much as a significant value proposition as we go into market. That is remarkably unique. And so we're feeling pretty confident at this stage. It's about locking and loading and getting ready for what we believe the FDA will deliver to us and for us. And we'll certainly have a lot more to say once that happens.

我們再次查閱美國指南，索格列淨有其特殊性，但我們尚未獲得批准。因此，即使該藥物尚未獲得批准，索格列淨和該數據的獨特性也已納入這些指南。因此，當我們進入市場時，我們將擁有這些指導方針以及這些指導方針的方式，這幾乎作為一個重要的價值主張。這是非常獨特的。所以我們現階段非常有信心。這是關於鎖定和裝載，並為我們相信 FDA 將向我們和為我們提供的東西做好準備。一旦發生這種情況，我們肯定會有更多話要說。

(Operator Instructions) Our next question comes from Joseph Stringer from Needham & Company.

（操作員說明）我們的下一個問題來自 Needham & Company 的 Joseph Stringer。

Just going back to the potential label scenarios for sota, you kind of outlined your base case broad label scenario. I guess do you feel that you need to have that base case broad label in order to be differentiated from the approved competitor drugs and be commercially successful? Or if sota does get approved with a more narrow label, do you still think that you could be differentiated and capture market share and ultimately be commercially successful?

回到 sota 的潛在標籤場景，您概述了基本案例的廣泛標籤場景。我想您是否認為您需要擁有基本案例廣泛的標籤才能與已批准的競爭對手藥物區分開來並取得商業上的成功？或者，如果 sota 確實以更窄的標籤獲得批准，您是否仍然認為您可以實現差異化並佔領市場份額並最終取得商業成功？

Thank you, Joseph. Let me first say, I'm pretty confident the scenario I gave you is a scenario that should be. However, I would say that patients are going to cycle on these compounds. And given the growth rate and the size of this market, the CAGR that we see, just the cycling of these compounds, we will have a significant opportunity. But the uniqueness of our data should we achieve what I've already laid out to you will indeed create a significant opportunity for sotagliflozin in quite a large product over time. So I'm pretty confident in my view around what I believe where we're going to land, and that's going to be the optimistic scenario.

謝謝你，約瑟夫。首先我要說的是，我非常有信心我給你的場景是應該的。然而，我想說的是，患者將繼續服用這些化合物。考慮到這個市場的增長率和規模，我們看到的複合年增長率，只是這些化合物的循環，我們將有一個巨大的機會。但是，如果我們實現我已經向您展示的目標，我們數據的獨特性確實會隨著時間的推移為 sotagliflozin 在相當大的產品中創造重要機會。因此，我對我們將要實現的目標非常有信心，這將是樂觀的情況。

And ladies and gentlemen, with that, we'll be concluding today's question-and-answer session. I'd like to turn the floor back over to the management team for any closing remarks.

女士們、先生們，我們今天的問答環節就到此結束。我想將發言權交還給管理團隊，讓他們發表結束語。

Well, as always, I want to thank everyone for joining us. This is such an awesome opportunity for Lexicon and our stakeholders this year. LX9211 will advance into late-stage development. We're feeling pretty good about that. We'll get the FDA feedback here shortly, and we'll know exactly how we want to advance LX9211. I feel confident that if we move into partnership, it would be under the terms that we think is important for us to generate value for all of our stakeholders.

一如既往，我要感謝大家加入我們。今年對於 Lexicon 和我們的利益相關者來說，這是一個絕佳的機會。 LX9211將進入後期開發。我們對此感覺很好。我們很快就會收到 FDA 的反饋，我們就會確切地知道我們想要如何推進 LX9211。我相信，如果我們建立合作夥伴關係，我們認為這對我們為所有利益相關者創造價值非常重要。

The second one is for sotagliflozin. We're feeling pretty bullish and, therefore, we have made the investments. Our people are on board. They're ready to go. The conversations with the FDA has been remarkably productive, and we're feeling, as I said, pretty confident that we are a short period away from turning the cards over and sharing with you what we've always believed is that we have a remarkably unique compound that we can bring to the market and begin to live our mission, and that's to ensure that patients have an opportunity to improve their lives with one of our innovations.

第二個是索格列淨。我們感覺非常樂觀，因此我們進行了投資。我們的員工都在船上。他們準備出發了。與 FDA 的對話非常富有成效，正如我所說，我們非常有信心，我們很快就會翻牌並與您分享我們一直相信的事情，即我們擁有一個非常好的我們可以將這種獨特的化合物推向市場並開始履行我們的使命，那就是確保患者有機會通過我們的一項創新來改善他們的生活。

With that, I'll thank you, and look forward to the next call.

在此，我會感謝您，並期待下次通話。

Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We thank you for joining. You may now disconnect your lines.

女士們先生們，我們今天的電話會議和演示就到此結束。我們感謝您的加入。您現在可以斷開線路。