Ironwood Pharmaceuticals, Inc. (IRWD) 2025 Q4 法說會逐字稿

Thank you for standing by. My name is Liz, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Ironwood Pharmaceuticals Q4 and full year 2025 Investor Update conference call. All lines have been placed on mute to prevent any background noise (Operator Instructions). Thank you. I would now like to turn the call over to Greg Martini, Chief Financial Officer. Please go ahead.

感謝各位稍候。我叫 Liz，今天將擔任本次電話會議的接線員。此刻，我謹代表公司歡迎各位參加 Ironwood Pharmaceuticals 2025 年第四季及全年投資人最新進展電話會議。為避免背景雜音干擾，所有線路已設為靜音（接線員指示）。謝謝。接下來我將把電話交給財務長 Greg Martini。請開始。

Good morning and thank you for joining us for our fourth quarter and full year 2025 Investor Update. A press release issued this morning can be found on our website.

各位早安，感謝各位參加我們 2025 年第四季及全年投資人最新進展說明。我們今早發布的新聞稿可於公司網站查閱。

Today's call and accompanying slides include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may cause actual results to differ materially.

今天的電話會議及隨附投影片包含《1995 年私人證券訴訟改革法》所定義的前瞻性陳述。此類陳述涉及風險與不確定性，可能導致實際結果與所述內容出現重大差異。

A discussion of these statements and risk factors is available on the current Safe Harbor statement slide, as well as under the heading Risk Factors in our annual report on Form 10-K for the year ended December 31, 2024, and in our subsequent SEC filings.

關於這些陳述及風險因素的討論，請參閱目前的「安全港」聲明投影片，以及我們截至 2024 年 12 月 31 日止年度的 Form 10-K 年報中「風險因素」章節，並參閱我們後續向 SEC 提交的文件。

All forward-looking statements speak as of the date of this presentation, and we undertake no obligation to update such statements.

所有前瞻性陳述僅截至本簡報日期為準，我們不承擔更新此類陳述的任何義務。

Also included are non-GAAP financial measures, which should be considered only as a supplement to and not a substitute for superior to GAAP measures.

本次亦包含非 GAAP 財務衡量指標，僅應作為 GAAP 指標之補充，而非替代或優於 GAAP 指標。

To the extent applicable, please refer to the tables at the end of our press release for reconciliations of these measures to the most directly comparable GAAP measures.

如適用，請參閱新聞稿末尾的表格，以取得這些指標與最直接可比之 GAAP 指標的調節表。

During today's call, Tom McCourt, our Chief Executive Officer, will begin with an overview of our 2025 progress on our strategic priorities and will provide an update on how we are maximizing Linzess. Mike Shetzline, our Chief Medical Officer, will discuss how we're advancing apraglutide, and I will review our financial results and 2026 guidance.

在今天的電話會議中，我們的執行長 Tom McCourt 將先概述 2025 年在策略優先事項上的進展，並更新我們如何最大化 Linzess 的價值。我們的首席醫療長 Mike Shetzline 將說明我們如何推進 apraglutide，而我將回顧財務結果並提供 2026 年指引。

Tammy Gaskins, our Chief Commercial Officer, will also be available for Q&A at the end of the call. Today's webcast includes slides, so for those of you dialing in, please go to the events section of our website to access the accompanying slides separately. With that, I'll turn the call over to Tom.

我們的首席商務長 Tammy Gaskins 也將在會議最後的問答環節出席。今天的網路直播包含投影片，因此對於以電話撥入的各位，請前往我們網站的活動（events）專區，另行取得隨附投影片。接下來我把電話交給 Tom。

Good morning, everyone and thanks for joining us today to review the fourth quarter and full year 2025 financial results and business updates. In 2025, we took several important steps to maximize LINZESS, advance apraglutide, and deliver sustained profits and cash flows to strengthen our financial position and position the company for long-term success.

各位早安，感謝各位今天加入我們，一同回顧 2025 年第四季及全年財務結果與業務更新。2025 年，我們採取了多項重要措施，以最大化 LINZESS、推進 apraglutide，並交付可持續的獲利與現金流，以強化財務狀況並使公司具備長期成功的定位。

Preludes us we delivered on the full year 2025 guidance with $865 million in LINZESS US net sales, supported by an impressive 11% demand growth and 8% new to brand volume growth year over year.

此外，我們達成了 2025 年全年指引：LINZESS 美國淨銷售額為 8.65 億美元；在需求成長 11% 以及「新用戶（new-to-brand）」用量年增 8% 的強勁表現支持下達成。

We also further strengthened the clinical utility of LINZESS with FDA approval in November of 2025, for the treatment of irritable bowel syndrome with constipation in patients seven years of age and older.

我們也在 2025 年 11 月取得 FDA 核准，進一步強化 LINZESS 的臨床效用，用於治療 7 歲及以上患者之便秘型腸躁症。

This new indication establishes LINZESS as the first and only prescription drug approved for the treatment of IBSC in patients 7 to 17 years of age. Which is great for patients in need.

這項新適應症使 LINZESS 成為首個且唯一獲核准用於治療 7 至 17 歲患者便秘型腸躁症（IBSC）的處方藥。這對有需求的患者而言是很好的消息。

In addition to expanding the clinical profile of LINZESS, we also took steps to lower the LINZESS list price effective January 1, 2026, in response to the evolving healthcare dynamics and to support ongoing patient access. For advancing apraglutide, we met with the FDA in the fourth quarter of 2025 and aligned on key elements of a confirmatory phase 3 clinical trial design, which we will be referring to as STARS-2.

除擴大 LINZESS 的臨床定位外，我們也因應不斷演變的醫療照護環境並支持患者持續可近性，採取措施將 LINZESS 的定價（list price）自 2026 年 1 月 1 日起下調。在推進 apraglutide 方面，我們於 2025 年第四季與 FDA 會面，並就一項確認性第 3 期臨床試驗設計的關鍵要素達成一致，我們將其稱為 STARS-2。

We're on track to begin site activation. In the second quarter of this year and continue to believe that the data generated in the prior STARS phase 3 trial will support an eventual NDA submission.

我們正按計畫於今年第二季開始啟動試驗中心（site activation），並仍相信先前 STARS 第 3 期試驗所產生的數據將支持未來提交 NDA。

Mike will discuss the phase 2 trial design in more detail later in the call. Lastly, for 2025, we finished the year strong, delivering $138 million in adjusted EBITDA and ended ending the year with $250 million of cash and cash equivalents on the balance sheet.

Mike 稍後將在電話會議中更詳細說明第 2 期試驗設計。最後，就 2025 年而言，我們以強勁表現收官，調整後 EBITDA 達 1.38 億美元，並在年末資產負債表上持有 2.5 億美元的現金及約當現金。

Positioning us well for 2026. Now looking ahead to 2026, on January 2, we announced a strong outlook for 2026 with our full year financial guidance highlighted by our expectation that Linds us will return to blockbuster status.

這使我們在 2026 年具備良好起點。展望 2026 年，1 月 2 日我們公布了 2026 年的強勁展望與全年財務指引，重點在於我們預期 Linzess 將重回重磅藥（blockbuster）地位。

With greater than $1.1 billion in US net sales in 2026 driven by improved net price and low single-digit prescription demand growth.

2026 年美國淨銷售額將超過 11 億美元，主要由淨價格改善以及處方需求低個位數成長所帶動。

We expect increased lends US net sales and our continued disciplined expense management to drive greater than $300 million in adjusted EBITDA in 2026, which will enable us to continue to advance apraglutide and reduce our debt to further strengthen our financial position.

我們預期 Linzess 美國淨銷售額增加，加上持續嚴謹的費用管理，將推動 2026 年調整後 EBITDA 超過 3 億美元；這將使我們得以持續推進 apraglutide，並降低負債以進一步強化財務狀況。

As such, our priorities in 2026 are clear. We'll continue to maximize LINZESS. We'll advance apraglutide by initiating STARS-2 for short bowel for short bowel syndrome patients with intestinal failure, and we'll continue to emphasize discipline, supply expense management to deliver profits and meaningful cash flows, which will enable us to reduce our debt and further strengthen our financial position.

因此，我們在 2026 年的優先事項非常明確。我們將持續最大化 LINZESS。我們將透過啟動 STARS-2 來推進 apraglutide，用於腸衰竭之短腸症候群患者；同時我們將持續強調紀律與嚴格的費用管理，以交付獲利與具意義的現金流，從而降低負債並進一步強化財務狀況。

With clear 2026 priorities and our improved financial position, we now have a clear path to execute our strategy, and we'll continue to evaluate all options to maximize shareholder value.

在 2026 年優先事項明確且財務狀況改善之下，我們已具備清晰的路徑來執行策略，並將持續評估所有選項以最大化股東價值。

Moving to slide 6. We're particularly excited about the opportunity we have with apraglutide, which has demonstrated strong efficacy and tolerability to date, becoming the first and only GLP-2 to achieve a statistically significant reduction in weekly parental support volume with once weekly administration.

接著看第 6 張投影片。我們對 apraglutide 的機會特別感到振奮；迄今其已展現強勁的療效與耐受性，並成為首個且唯一以每週一次給藥即可在統計上顯著降低每週腸外營養/支持（parenteral support）用量的 GLP-2。

Patients in our open label extension study, STARS extend, continue to reduce parental support volumes with longer-term exposure to apraglutide. Data presented at the American College of Gastroenterology meeting in October reported 34 patients have achieved and maintained mental autonomy or complete weaning of parental support for at least three months.

在我們的開放標籤延伸研究 STARS extend 中，患者在更長期暴露於 apraglutide 後，仍持續降低腸外支持用量。於 10 月美國胃腸病學會（American College of Gastroenterology）年會發表的數據指出，有 34 名患者已達成並維持腸道自主（enteral autonomy）或完全停用腸外支持至少三個月。

Our conviction for the commercial opportunity for apraglutide remains high because of the strength of these data and the fact that many GLP-2 eligible patients with high parental support burden go untreated or discontinue therapy.

基於這些數據的強度，以及許多符合 GLP-2 治療資格且腸外支持負擔沉重的患者未接受治療或中止治療的現況，我們對 apraglutide 的商業機會仍維持高度信心。

We believe that the clinical profile with demonstrated efficacy, tolerability, and once weekly administration of apraglutide. Can redefine standard of care for short bowel syndrome with the potential to improve adherence and increase the number of GLP-2 treated patients.

我們相信 apraglutide 具備已證實的療效、耐受性以及每週一次給藥的臨床特性，可望重新定義短腸症候群的照護標準，並有潛力提升依從性、增加接受 GLP-2 治療的患者人數。

To generate greater than $700 million in US peak net sales. The addition of potential approvals in geographies abroad would further increase the opportunity.

從而在美國創造超過 7 億美元的淨銷售額峰值。若再加上海外地區的潛在核准，機會將進一步擴大。

I'd also like to take a moment to acknowledge that February 1, was Intestinal failure Awareness Day, and February is Rare Disease Month. As we work towards our goal of developing and commercializing life changing therapies for patients suffering from GI and rare diseases.

我也想花一點時間提及：2 月 1 日是「腸衰竭關注日」（Intestinal Failure Awareness Day），而 2 月是「罕見疾病月」。我們正朝著開發並商業化能改變生活的療法之目標邁進，以幫助罹患腸胃道（GI）及罕見疾病的患者。

We also seek to increase awareness for people we serve who are at the center of our work year-round. Short bowel syndrome is a devastating condition, and we thank you for your trust as we work with urgency to deliver this important new medicine to short bowel syndrome patients who are dependent on parental support. With that, I'll now hand it over, I will now move to our commercial performance update on page 7.

我們也致力於提升我們所服務的人群對相關議題的認知，因為他們全年都是我們工作的核心。短腸症候群是一種極具破壞性的疾病；在我們以緊迫感推動將這項重要新藥帶給依賴腸外營養支持的短腸症候群患者之際，感謝您對我們的信任。接下來，我將把時間交接，並在第 7 頁說明我們的商業表現更新。

Throughout 2025, Lins continued to maintain its prescription market leadership. For the treatment of IBSC and chronic constipation in the US, recently surpassing 5.7 million unique patients treated since launch and ending the year with roughly 45% market share.

在 2025 年全年，Linzess 持續維持其處方市場的領導地位。在美國用於治療 IBS-C 與慢性便秘方面，自上市以來累計治療的獨立患者數近期已超過 570 萬人，並在年底約取得 45% 的市占率。

With over 40 million addressable patients in the US, we believe LINZESS still has a significant potential to grow prescription demand over the over the coming years due to the significant unmet need and the dissatisfaction with OTC therapies.

美國可觸及患者超過 4,000 萬人；我們相信，由於仍存在顯著未被滿足的醫療需求，以及對非處方（OTC）療法的不滿，LINZESS 在未來幾年仍具有推動處方需求成長的巨大潛力。

Once again, LINZESS delivered strong double-digit demand growth, increasing 13% year over year for the fourth quarter and 11% for the full year in 2025, the second consecutive year delivering 11% prescription demand growth.

LINZESS 再次交出強勁的雙位數需求成長：2025 年第四季年增 13%，全年年增 11%，這也是連續第二年達成 11% 的處方需求成長。

LINZESS demand growth consistently outpaced the market and was supported by all-time highs in new to brand patient volumes.

LINZESS 的需求成長持續領先市場，並受惠於「新轉入本品牌」患者量創歷史新高。

Turning to 2026. After two consecutive years of declining LINZESS net sales driven by price headwinds associated with legislative changes, we expect to return lends US net sales growth in 2026.

接著談 2026 年。在立法變動所帶來的價格逆風影響下，LINZESS 淨銷售已連續兩年下滑；我們預期 2026 年將恢復 LINZESS 美國淨銷售成長。

Effective January 1, LINZESS's list price was lowered in response to the evolving healthcare dynamics and to support ongoing patient access.

自 1 月 1 日起，為回應不斷演變的醫療照護環境並支持患者持續可近性，LINZESS 的定價（list price）已下調。

As a result of this change, we expect more than a 30% increase in 2026 LINZESS US net sales year over year. Specifically driven by the elimination of the inflationary component of statutory required rebates across the channels, including Medicaid, due to this decrease in list price.

受此變更影響，我們預期 2026 年 LINZESS 美國淨銷售將較去年同期成長超過 30%。此成長主要來自於：因名目定價下調，使各通路（含 Medicaid）法定必須支付之回扣中的通膨加成（inflationary component）被消除。

We've maintained our class leading payer access in 2026, and expect low single-digit prescription demand growth over the course of the year. With this improved pricing and net sales growth, we expect LINZESS will continue to drive meaningful cash flows to fund the next stage of growth with the commercialization of apraglutide if approof. With that, I'll turn the call over to Mike to share more details on the continued development of apraglutide. Mike.

我們在 2026 年維持同類最佳的支付方准入（payer access），並預期全年處方需求將呈現低個位數成長。在定價改善與淨銷售成長的帶動下，我們預期 LINZESS 將持續產生可觀現金流，以資助下一階段的成長，包括 apraglutide（若獲核准）的商業化。接下來我把電話交給 Mike，請他分享更多 apraglutide 持續開發的細節。Mike。

Thanks, Tom, and good morning, everyone. 2026 is shaping up to be a critical year for advancing the apraglutide development program with the launch of our phase 3 confirmatory trial, STARS-2, expected in the second quarter of 2026.

謝謝你，Tom，各位早安。2026 年正逐步成為推進 apraglutide 開發計畫的關鍵一年；我們預計於 2026 年第二季啟動第三期確認性試驗 STARS-2。

In April 2025, we announced that the FDA requested a confirmatory phase 3 trial to seek approval for apraglutide, given the pharmacokinetic analysis of our prior STARS phase 3 data indicated that the exposure and dose delivered in the trial were lower than planned due to dose preparation and administration.

在 2025 年 4 月，我們宣布 FDA 基於我們先前 STARS 第三期數據的藥物動力學分析而要求進行一項確認性第三期試驗，以尋求 apraglutide 的核准；該分析顯示，由於劑量製備與給藥因素，試驗中實際暴露量與給藥劑量低於原先規劃。

As a reminder, STARS was the largest ever phase 3 trial conducted of the treatment for short bowel syndrome with intestinal failure, and we continue to anticipate this data set, along with the data from STARS-2 will support a future NDA submission. As Tom mentioned, we met with the FDA in the fourth quarter of 2025 and aligned on key elements for the STARS-2 trial, and we're pleased to share some initial details with you today.

提醒一下，STARS 是迄今針對「合併腸衰竭之短腸症候群」治療所進行的最大規模第三期試驗；我們仍預期該資料集將與 STARS-2 的資料一併支持未來的 NDA 申請。如 Tom 所提，我們在 2025 年第四季與 FDA 會面，並就 STARS-2 試驗的關鍵要素達成一致；我們也很高興今天與各位分享一些初步細節。

For STARS-2, we plan to enroll 124 patients with short bowel syndrome with intestinal failure in a one-to-one randomization. Enrollment will include patients with both stoma and colon in continuity anatomy to be representative of the heterogeneity of the overall population of patients with this condition.

在 STARS-2 中，我們計畫以 1:1 隨機分派納入 124 名合併腸衰竭之短腸症候群患者。收案將包含同時具有造口（stoma）以及結腸連續（colon in continuity）解剖型態的患者，以反映此疾病整體患者族群的異質性。

Our primary endpoint for the study will be the same as our prior STAR phase 3 clinical trial evaluating the relative change from baseline in actual weekly parenteral support volume at week 24 in the overall patient population.

本研究的主要終點將與先前 STAR 第三期臨床試驗相同：評估在整體患者族群中，第 24 週實際每週腸外支持（parenteral support）量相較基線的相對變化。

Key secondary endpoints also to be measured at week 24 for the overall population include clinical response defined as less than 20% reduction of defined at least 20% reduction in parental support volume, number of days off parental support per week, and enteral autonomy.

同樣於第 24 週評估、針對整體族群的關鍵次要終點包括：臨床反應（定義為腸外支持量至少降低 20%）、每週不需腸外支持的天數，以及腸內自主（enteral autonomy）。

Patients will receive a 3.5 milligram once weekly dose of apraglutide to align with what was delivered in the prior phase 3 trial. In designing this STARS-2 trial, we have leveraged learnings from a prior STARS phase 3 to refine the instructions for use to optimize dose administration.

患者將接受每週一次 3.5 毫克的 apraglutide 劑量，以與先前第三期試驗實際給予的劑量一致。在設計 STARS-2 試驗時，我們運用先前 STARS 第三期試驗的經驗，精進使用說明（instructions for use），以最佳化給藥操作。

We expect to begin initiation of trial sites in the second quarter of 2026 and anticipate the study timeline to support an NDA submission before the end of 2029.

我們預期於 2026 年第二季開始啟動試驗中心，並預估研究時程可支持在 2029 年底前提交 NDA。

We are encouraged by the efficacy and tolerability data of apraglutide to date through the STARS trial and the long-term extension study, which give us confidence in the potential outcome of this confirmatory trial and in apraglutide's potential to be a best-in-class treatment for short bowel syndrome with intestinal failure as we pursue an eventual regulatory approval.

截至目前，透過 STARS 試驗與長期延伸研究所取得的 apraglutide 療效與耐受性資料令我們備受鼓舞；這些結果使我們對此確認性試驗的潛在結果更具信心，也讓我們相信在追求最終法規核准的過程中，apraglutide 有潛力成為治療合併腸衰竭之短腸症候群的同類最佳療法。

We look forward to initiating the STARS-2 trial as we continue to grow our body of clinical evidence supporting apraglutide's potential to become the first long acting once weekly GLP-2 therapy for the treatment of short bowel syndrome if approved. With that, I'll turn it over to Greg to review our financial performance in 2025. Greg.

我們期待啟動 STARS-2 試驗，並持續累積臨床證據，以支持 apraglutide（若獲核准）有潛力成為首個長效、每週一次的 GLP-2 療法，用於治療短腸症候群。接下來我把時間交給 Greg，請他回顧我們 2025 年的財務表現。Greg。

Thanks, Mike. We ended 2025 in a strong financial position, achieving our latest full year 2025 guidance. Turning to slide 14 to review full year 2025 financial highlights.

謝謝你，Mike。我們在 2025 年底以強勁的財務狀況收官，並達成我們最新的 2025 全年財測指引。接著請看第 14 張投影片，回顧 2025 全年財務重點。

LINZESS US net sales were $163 million in the fourth quarter and $865 million for the full year. Fourth quarter, LINZESS US net sales decreased 27% year over year, with net price erosion being partially offset by 13% prescription demand growth.

LINZESS 美國淨銷售在第四季為 1.63 億美元，全年為 8.65 億美元。第四季 LINZESS 美國淨銷售年減 27%；其中淨價格下滑部分被 13% 的處方需求成長所抵銷。

Fourth quarter net price was impacted by unfavorable quarterly phasing of gross to net rebate reserves due to units dispensed for the quarter exceeding units sold to wholesalers.

第四季淨價格受到不利影響，原因是毛額到淨額（gross-to-net）回扣準備金在季度間的分攤時點不利：當季實際調劑（dispensed）單位數高於銷售給批發商的單位數。

As a reminder, in the fourth quarter of 2025, in the first quarter of 2025, we noted a change in ABV's estimate of gross to net rebate reserves for 2025, based on expected rebates owed for units dispensed by channel in each quarter, which was expected to impact the quarterly phasing of LINZESS US net sales but not impact full year results.

提醒一下：在 2025 年第一季，我們提到 ABV 對 2025 年毛額到淨額回扣準備金估計有所調整，係基於各季度按通路就已調劑單位所預期應付的回扣；此調整預期會影響 LINZESS 美國淨銷售的季度分攤時點，但不影響全年結果。

Accordingly, full year LINZESS US net sales decreased 6% year over year, with net price erosion primarily associated with the Medicare Part D redesign, partially offset by 11% prescription demand growth.

因此，LINZESS 美國全年淨銷售年減 6%；淨價格下滑主要與 Medicare Part D 改制相關，並部分被 11% 的處方需求成長所抵銷。

Total Ironwood revenue was $296 million. GAAP net income was $24 million and adjusted EBITDA was $138 million.

Ironwood 總營收為 2.96 億美元。GAAP淨利為 2,400 萬美元，調整後 EBITDA 為 1.38 億美元。

Now moving to our balance sheet. We significantly improved our financial position by the end of 2025. Disciplined expense management, including a $61 million reduction in operating expenses year over year, resulted in $127 million in cash flows from operations and $215 million of cash in cash equivalents at year end.

接著看資產負債表。截至 2025 年底，我們的財務狀況已顯著改善。嚴謹的費用管理（包括營業費用年減 6,100 萬美元）帶來 1.27 億美元的營運現金流，且年底現金及約當現金為 2.15 億美元。

We expect our strong cash position and 2026, outlook will support delivering of our balance sheet while simultaneously funding investment to drive long-term growth. We plan to use our cash on hand and cash flows generated to reduce our total debt balance in 2026, including repayment of our 2026, convertible notes at maturity in June, and expect to end the year with approximately $300 million of debt on the balance sheet, less than one-time 2026 adjusted EBITDA by year end.

我們預期，我們強勁的現金部位與 2026 年展望，將支持我們強化資產負債表，同時為推動長期成長的投資提供資金。我們計畫在 2026 年運用手頭現金與所產生的現金流來降低總負債餘額，包括於 6 月到期時償還我們 2026 年可轉換公司債，並預期年底資產負債表上的債務約為 3 億美元，低於年底一次 2026 年調整後 EBITDA。

Moving to our financial guidance on slide 16, we are reiterating our 2026 guidance. This includes US LINZESS net sales between $1.125 billion and $1.175 billion a greater than 30% increase year over year driven by improved net price and low single-digit prescription demand growth.

接著看投影片 16 的財務指引，我們重申 2026 年指引。其中包括美國 LINZESS 淨銷售額介於 11.25 億至 11.75 億美元，年增超過 30%，主要由淨價格改善與處方需求低個位數成長所帶動。

We expect Ironwood revenue between $450 million and $475 million and we expect adjusted EBITDA of greater than $300 million.

我們預期 Ironwood 營收介於 4.5 億至 4.75 億美元，並預期調整後 EBITDA 超過 3 億美元。

In summary, we are entering 2026 in a position of renewed financial strength and have a clear set of priorities as we strive to deliver long-term value by maximizing LINZESS, advancing apraglutide, and delivering sustained profits and cash flows.

總結來說，我們以重拾的財務實力邁入 2026 年，並有一套明確的優先事項；我們致力於透過最大化 LINZESS、推進 apraglutide，以及實現持續的獲利與現金流，來創造長期價值。

We look forward to beginning site initiation for STARS-2, a confirmatory phase 3 trial for apraglutide in the second quarter, and we believe we have the opportunity to redefine the standard of care for patients living with short bowel syndrome with intestinal failure.

我們期待在第二季開始啟動 STARS-2 的試驗中心（site initiation）；STARS-2 是 apraglutide 的確認性第三期試驗。我們相信，我們有機會為罹患合併腸衰竭的短腸症候群患者，重新定義照護標準。

I want to close by thanking all of our employees, patients, caregivers, and advocates for their shared dedication to advancing life-changing therapies for patients with GI and rare diseases. Operator, you may now open up the line for questions.

最後，我要感謝所有員工、病患、照護者與倡議者，大家共同致力於推動能改變生命的療法，造福腸胃道（GI）與罕見疾病患者。接線員，現在可以開放提問。

(Operator Instructions).

（接線員指示）。

Jason Butler, Citizens.

Jason Butler，Citizens。

Hey, thanks for taking the question. Just a couple on STARS-2. You, can you give us any more details on the learnings and, from STARS and the refined options for use that you're now including in the STARS-2? Can you also just give us an overview of where you and FDA aligned on using the same primary and key secondary endpoints? What gives you the confidence in repeating the data from STARS-1.

嗨，謝謝讓我提問。關於 STARS-2 我有幾個問題。你們能否提供更多關於 STARS 的學習重點，以及你們現在納入 STARS-2 的、經精煉後的使用選項的細節？也請你們概述一下，你們與 FDA 在採用相同主要終點與關鍵次要終點方面，是如何達成一致的？是什麼讓你們有信心能重現 STARS-1 的數據？

And then just lastly, when you think about the enrollment timeline and enrollment criteria, how should we think about, a, the ability to enroll the trial on the timeline you gave, and B, the similarities of the patient populations between one and two. Thank you.

最後，談到收案時程與收案標準，我們應該如何看待：A，你們在所提供的時程內完成收案的能力；以及 B，一期與二期之間病患族群的相似性？謝謝。

Thanks Jason. Mike.

謝謝 Jason。Mike。

Yeah, thanks Jason. So in terms of the learnings, as the original STARS trial was a very successful outcome in terms of the primary endpoint and the benefit for patients as well as the GI and other systemic tolerability.

好的，謝謝 Jason。就學習重點而言，原始的 STARS 試驗在主要終點上取得非常成功的結果，對病患的效益亦然，同時在腸胃道（GI）及其他全身性耐受性方面也表現良好。

As we mentioned, what we learned most was about the dose and administration and what was involved in discussion with the agency was along those lines. So we really made a great effort in the revised approach to STARS-2 to ensure very accurate dosing and administration with better kit components and also instructions for use. I mean, that's the main difference, so to speak, in the two trials.

如我們所提到的，我們最大的學習在於劑量與給藥方式；與主管機關的討論也主要圍繞在這些面向。因此，在 STARS-2 的修訂方案中，我們投入很大努力，透過更好的套組組件以及使用說明，來確保劑量與給藥非常精準。也就是說，這是兩個試驗之間的主要差異。

In terms of your next question was about the alignment on the endpoints. The agency clearly appreciated the endpoint in the primary STARS trial, the trial we completed successfully, and that's why the STARS-2 trial has the same primary endpoint as well as the.

至於你下一個問題，關於終點的一致性。主管機關顯然認可我們已成功完成的主要 STARS 試驗中的終點，因此 STARS-2 試驗採用相同的主要終點，以及相同的。

In the key secondary endpoints as well, so those remain pretty much the same, and we obviously have a high degree of confidence in the outcome of the STARS-2 trial because of that similarity, and we do think we've drastically improved the instructions for use and the dose and administration for patients.

關鍵次要終點也一樣，因此這些幾乎維持不變；基於這種相似性，我們對 STARS-2 試驗的結果有很高的信心。同時，我們確實大幅改善了病患的使用說明、劑量與給藥方式。

So expect that to be a positive contribution for the study as well. In terms of timelines, we learned a lot with the STARS original program. We certainly have taken those learnings to better inform us to start the STARS-2 trial. We already have a lot of sites in the STARS Extend program which we're going to continue to use as well, so we're thinking we're in a good position.

因此我們預期這也會對研究帶來正面貢獻。就時程而言，我們從原始 STARS 計畫中學到很多。我們確實已將這些學習納入，以更好地指引我們啟動 STARS-2 試驗。我們在 STARS Extend 計畫中已經有許多試驗中心，我們也會持續使用，因此我們認為我們處於良好位置。

To successfully enroll the program in a timely fashion, that's why we put the timelines on the table in this call, but we're certainly going to do everything we can. It's a lot of work and the team puts a lot of effort into it. We're going to have to push to make it successful, but we absolutely believe we can do that and achieve it in the timelines we propose.

能夠在合理時間內成功完成收案，這也是我們在本次電話會議中提出時程的原因；但我們當然會盡一切努力。這需要大量工作，團隊也投入很多心力。我們必須全力推進以確保成功，但我們絕對相信我們能做到，並在我們提出的時程內達成。

That that's great. I appreciate all the details.

太好了。感謝所有細節。

Chase Knickerbocker, Craig Holland.

Chase Knickerbocker，Craig Holland。

Good morning. Thanks for taking the questions. Maybe just to start on the strategic alternatives process in a respect, we're not getting, a kind of a formal update, but can you maybe just update us on your thinking as far as kind of now that you can, at least in our model, clearly continue on as a standalone company, you retire the debt, kind of how you're thinking about the strategic alternatives process, as we kind of go forward in the '26.

早安。謝謝讓我提問。先從策略替代方案流程談起：我們沒有收到正式更新，但你們能否更新一下你們的想法？就我們的模型來看，你們現在顯然可以繼續作為一家獨立公司運作、償還債務；你們如何看待策略替代方案流程在 2026 年往後的走向？

Thanks Chase. This is Tom, and you know we're obviously in a very different financial position today than we were nine months ago when we were looking at, what were, what are our strategic alternatives, and I think because of that, we clearly have a path forward to certainly, leverage the revenue that is coming, the increased revenue that's coming off lends us.

謝謝 Chase。我是 Tom。你知道，相較於九個月前我們在評估策略替代方案時，今天我們的財務狀況顯然非常不同；我認為也正因如此，我們清楚有一條前進的路徑：確實可以運用即將到來的營收、來自 LINZESS 的營收成長所帶來的槓桿效益。

As well as reduce our debt and mobilize the trial. That being said, we're obviously always open to alternatives that would increase shareholder value, there was a lot of interest, in Ironwood and in our assets, but we wanted to make sure that we were really smart with regard to the choices we made to make sure that we could protect the shareholders.

同時降低我們的負債並推動試驗。話雖如此，我們當然始終對能提升股東價值的替代方案保持開放；市場對 Ironwood 及我們的資產有很高興趣，但我們希望在所做的選擇上非常審慎，以確保能保護股東。

So I think as we move forward. We'll focus on executing as quickly as we can and as strongly as we can and always consider, are there ways in which we can increase your holder value.

因此我認為，隨著我們往前走，我們會專注於以最快、最強的執行力來推進，同時也會一直思考：是否有方法能提升股東價值。

Understood. Thanks. Maybe just, another one for Mike on the, on STARS-2. It seems like timelines, expectations for full enrollment are somewhat similar to STARS-1, maybe a little bit shorter, maybe just talk about kind of some of the assumptions you're making.

了解。謝謝。另外一題想請教 Mike，關於 STARS-2。看起來完成全部收案的時程與 STARS-1 相當接近，可能稍微短一些；能否談談你們所做的一些假設？

As far as kind of that time timeline to full enrollment, I know there's another, large study in the same patient population, at least relative to overall, kind of market size. Can you just kind of talk about some of the assumptions that you're making on total enrollment as it compares to STARS-1?

就完成全部收案的時程而言，我知道在相同病患族群中還有另一項大型研究，至少相對於整體市場規模來看。你能否談談你們在總收案方面所做的假設，以及與 STARS-1 相比的情況？

I think that's a good question, Chase. Thanks for the question. I think it's you're correct in a lot of ways. We've aligned with how we saw STARS-1 play out. We thought we did a fair job executing that study as well. So that's where a lot of the assumptions are based. We certainly I think we can achieve that in the STARS-2 program, and that's what the team is pushing and positioning to do and deliver, the trial as we project here for an eventual NDA submission, but it really is grounded in what we did in STARS-1, which, as we said, was a very successful study.

我認為這是個好問題，Chase。謝謝你的提問。我想你在很多方面說得沒錯。我們的規劃與我們看到 STARS-1 的進展方式一致。我們認為我們在執行那項研究上也做得不錯。因此許多假設都是以此為基礎。我們確實相信我們能在 STARS-2 計畫中達成，而團隊也正全力推進並做好布局，以如我們在此所預期的方式交付試驗，最終用於 NDA 申請送件；但這確實是建立在我們在 STARS-1 所做的事情之上，而如我們所說，那是一項非常成功的研究。

The other thing, to consider here, Chase, is, this is a very attractive study if you're a patient. You think about how strong the drug performed in the first trial, so there's a very high probability of success, it's an extremely well tolerated once weekly dosing administration and it's a 24 week trial.

Chase，另外一點要在這裡考量的是，對病人而言，這是一項非常有吸引力的研究。想想這個藥在第一個試驗中的表現有多強，因此成功機率非常高；它是每週一次給藥、耐受性極佳的給藥方式，而且是為期 24 週的試驗。

So I think when you combine the fact that you have a very high probability of success, you have a, highly effective, extremely well tolerated once weekly therapy, and a 24 week trial, I think we're delighted with what Mike has been able to do with the FDA as far as, not only get the trial up and running with the design we have, but also, the length of the trial as well, which obviously. Is a big driver, with regard to the time to get to market.

所以我認為，當你把成功機率非常高、療效很強且耐受性極佳的每週一次治療，以及 24 週的試驗這些因素結合起來看，我們對 Mike 能夠與 FDA 合作所達成的成果感到非常高興——不僅讓試驗依照我們的設計啟動並運行，也包括試驗的長度，這顯然。是影響上市時間的一個重要驅動因素。

Got it. Maybe just less for me on, actually going to ask a question on 2027, but just on LINZESS, as we kind of approach that negotiated price, can you maybe just talk to us about kind of what you've seen in the market, from prior negotiated drugs as far as, actually kind of some volume acceleration as we kind of go into that negotiated price here, and kind of how you think, we should be thinking about 2027, for LINZESS, when that negotiated price goes into place.

了解。也許先不談 2027（我本來想問 2027 的問題），但就 LINZESS 而言，隨著我們逐步接近那個協商後價格，你能否跟我們談談你在市場上看到的情況——就先前已協商藥品而言，當我們進入協商價格前後，是否真的會出現某種用量加速；以及你認為我們應該如何看待 2027 年 LINZESS 在協商價格生效時的影響。

Yeah, thanks, Chase. This is Greg. So for 2026, we're clearly excited about the improved outlook that we have with our guidance that we provided back in January, reiterated today. We have a significant growth we're expecting in LINZESS net sales for 2026. We haven't provided any guidance for 2027, and beyond, but I would say that we continue to be very optimistic about the future of the brand and its ability to continue to drive strong net sales, which will continue to deliver profits and cash flows for Ironwood.

好的，謝謝你，Chase。我是 Greg。就 2026 年而言，我們顯然對前景改善感到振奮，這反映在我們 1 月提供、並在今天再次重申的財測指引上。我們預期 2026 年 LINZESS 淨銷售額將有顯著成長。我們尚未提供 2027 年及之後的指引，但我想說的是，我們仍然對該品牌的未來及其持續推動強勁淨銷售額的能力非常樂觀，而這也將持續為 Ironwood 帶來利潤與現金流。

Understood, thanks.

了解，謝謝。

Amy Li, Jefferies.

Amy Li，Jefferies。

Hey, thanks so much for taking my question. So, for STARS-2, how much of your existing clinical data is the FDA allowing you to reference or bridge to a future NDA? And I think, people have said that your planned enrollment size seems slightly higher than your competitors, which is enrolling 90 patients.

嗨，謝謝你們回答我的問題。關於 STARS-2，FDA 允許你們引用或銜接多少既有的臨床資料，用於未來的 NDA？另外我想，外界有人提到你們計畫的入組人數似乎比競品略高，對方入組 90 位病人。

So just curious if the trial size was by FDA request or is it more conservative decision on your end to have a more robustly powered trial. And then finally, given the competitive pressure in SBS-IF and potential for [adherence], could you potentially add a higher dose arm to maximize efficacy differentiation?

所以想請教，試驗規模是 FDA 的要求，還是你們端較為保守、希望試驗把握度更高的決定？最後，考量 SBS-IF 的競爭壓力以及可能的[依從性]問題，你們是否可能加入一個更高劑量組，以最大化療效差異化？

Yeah, thanks, Amy. So yeah, so in terms of the STARS-2 data, we were hoping to leverage the STARS data as much as possible, honestly, as we said, we're bridging based on the similar dose. The dose is aligned in the STARS-2 trial with what we put in the STARS original trial, so we're anticipating that we'll have to, we'll be able to use.

好的，謝謝你，Amy。就 STARS-2 的資料而言，坦白說我們希望盡可能多地運用 STARS 的資料；如我們所說，我們是基於相同劑量來做銜接（bridging）。STARS-2 試驗中的劑量與我們在原始 STARS 試驗中使用的劑量一致，因此我們預期我們將必須、也將能夠使用。

The original STARS data in the NDA submission. Now, obviously that's going to be a review decision because obviously we'll have to see the data and progress the trial as planned, but given that PK bridging, we think that the STARS original STARS data will be applicable for our future NDA.

原始 STARS 的資料納入 NDA 申請。當然，這會是一個審查決定，因為我們必須看到資料並按計畫推進試驗；但基於 PK 銜接，我們認為原始 STARS 資料將適用於我們未來的 NDA。

In terms of the size of the STARS trial, we certainly did align with the agency on the key elements of the program to take forward, and we believe this current sample size that we've put on the table here with 124 patients gives us adequate and robust power along the primary endpoint and secondary endpoints as well.

至於 STARS 試驗的規模，我們確實就推進該計畫的關鍵要素與主管機關達成一致；我們相信目前提出的 124 位病人的樣本數，能在主要終點與次要終點上提供充分且穩健的統計把握度。

And so that's what really drove the decision on the sample. Was to make sure we had a very robust clinical trial and confidence in the outcome. That's what we wanted to achieve. We recognize there may be differences with some other trials being performed, but this is where we settled based on the confidence we have in the program. We also had a significant amount of data from 07 to put strong numbers behind that selection.

因此，這就是促成樣本數決策的主要原因。也就是要確保我們有一個非常穩健的臨床試驗，並對結果有信心。這是我們想達成的目標。我們理解其他正在進行的試驗可能有所不同，但基於我們對該計畫的信心，這是我們最後定下來的設計。我們也有來自 07 的大量資料，為這個選擇提供有力的數據支持。

And your last comment was about the higher doses. I think again we certainly have considered, continue to consider the opportunity with high doses. We're actually in, I think, an excellent position given the fact that SARS already has very robust efficacy data with a potential best in class profile and outstanding GI tolerability and weekly dosing.

你最後一個問題是關於更高劑量。我想我們當然已經考慮、也會持續評估高劑量的機會。事實上，鑑於 STARS 已經有非常扎實的療效資料、具備潛在同類最佳（best-in-class）的特徵，以及出色的腸胃道耐受性與每週一次給藥，我認為我們目前處於非常有利的位置。

So we certainly want to leverage that going forward, but we do continue to evaluate the opportunity to introduce a higher dose. As not everybody responds in a clinical trial, so there's certainly opportunity to potentially increase the breadth of response. But right now we're focused on getting fastest to market, and the best way to do that is to bridge with the 07 or the original STARS data set and complete this trial and confirm that evidence for an eventual submission.

因此我們當然希望在未來加以運用；但我們也持續評估引入更高劑量的機會。因為在臨床試驗中並非每個人都有反應，所以確實可能有機會擴大反應族群的範圍。但目前我們的重點是以最快速度上市，而最好的方式就是用 07 或原始 STARS 資料集來做銜接，完成這項試驗，並確認最終申報所需的證據。

Got it. Thank you so much.

了解。非常感謝。

Mohit Bansal, Wells Fargo.

Mohit Bansal，Wells Fargo。

Good. Thank you very much for taking my question and congrats on all the progress here. So a couple of questions from my side. So one is, did you ever see data from the STARS trial to look at patients who could achieve the optimum dose? Did they benefit more than the other patients who couldn't get to the optimum dose? That's the first question.

你好。非常感謝你們回答我的問題，也恭喜你們在這裡取得的所有進展。我這邊有幾個問題。第一個是，你們是否曾查看 STARS 試驗的資料，去看那些能達到最佳劑量（optimum dose）的病人？他們是否比那些無法達到最佳劑量的病人獲益更多？這是第一個問題。

And the second question, I would love to understand how you are thinking about market opportunity for APRA in the case, you have [Gat-X] generic potentially reaching the market around the same time that is the latest on the Gat-X generic at this point?

第二個問題，我想了解你們如何看待 APRA 的市場機會——在你們的情境下，[Gat-X] 的學名藥可能在差不多同一時間上市；目前 Gat-X 學名藥的最新進展是什麼？

Thank you.

謝謝。

How about I start with your question. Thanks, good question on the optimum dose. I think it's a really great question because obviously you raised the point of optimum dose. I think what has been amazing in the original STARS data set is the robust efficacy in the presence of basically placebo-like tolerability.

我先從你的問題開始回答。謝謝，關於最佳劑量的問題問得很好。我認為這真的是個很好的問題，因為你提到了最佳劑量這一點。我覺得在原始 STARS 資料集中最令人驚豔的是：在幾乎像安慰劑一樣的耐受性背景下，仍展現出強勁的療效。

So that's a pretty amazing outcome in our industry where you really don't see any really negative consequences and it was. Pretty robust large trial, so that is quite a big learning. So we really think we had a way to get into sort of optimum dose with the STARS trial, and as I mentioned, that came out to be 3.5 milligram, which is what we're taking forward in the STARS-2 I think in the background of your question is kind of what we alluded to earlier is there an opportunity for greater efficacy?

這在我們這個產業是相當驚人的結果，因為你幾乎看不到任何真正負面的後果，而且那是一項。相當穩健的大型試驗，所以這是非常重要的學習。因此我們確實認為，在 STARS 試驗中我們找到了一種方式來達到所謂的最佳劑量；如我提到的，最後是 3.5 毫克，這也是我們在 STARS-2 中要推進的劑量。我想你問題背後的含意，某種程度上是我們先前提到的：是否有機會獲得更高的療效？

And as we did do some early trials looking at 2.55 milligrams and 10 milligrams from a biomarker perspective. So there clearly is some biomarker evidence that there could be some response out there above 3.5, and as I said, we certainly have been considering that, but for right now, with again giving the optimum outcome we have in the original STARS trial, meaning robust efficacy in a very well tolerated once weekly therapy that people like, maintain, and continue because we still see improved outcomes even a year and two years out in the.

而我們確實做過一些早期試驗，從生物標記（biomarker）的角度觀察 2.55 毫克與 10 毫克。所以很明顯有一些生物標記證據顯示，在 3.5 以上可能仍存在反應空間；如我所說，我們當然一直在考慮這點。但就目前而言，鑑於我們在原始 STARS 試驗中得到的最佳結果——也就是在一個病人喜歡、能維持並持續使用的每週一次治療下，展現強勁療效且耐受性非常好——而且我們仍看到在一年、兩年後的。

STARS extend trial. We really think the best opportunity is to take that forward in the confirmatory trial and get to market as soon as possible because as we're hearing, patients and investigators really like the drug and really want to maintain patience on it, and we'd like to get it to market as soon as possible. I think for the market question.

STARS 延長試驗。我們確實認為，最好的機會是把它推進到確認性試驗中，並盡快上市，因為正如我們聽到的，病患與研究者都非常喜歡這個藥，也很希望讓病患持續用藥，而我們也希望能盡快把它推向市場。我想就市場的問題。

Yeah, hi Mohit, this is Tammy. Thanks for the question on the commercial opportunity. Just to echo Mike's comments commercially, we have very strong conviction.

是的，嗨 Mohit，我是 Tammy。謝謝你關於商業機會的提問。就商業面來說，我想呼應 Mike 的評論，我們有非常強的信心。

In the overall clinical profile of glutide, right, and its potential to be differentiated in the GLP-2 class, especially because as Mike was just talking about, not only do we have a positive phase 3 trial, but also in the STARS extend long-term extension study, we continue to see increased improvement and PS volume reduction and days off of PS and even internal autonomy achievement, which we know.

就 glutide 的整體臨床特徵而言，對吧，以及它在 GLP-2 類別中具備差異化的潛力，特別是如同 Mike 剛才提到的，我們不僅有一項正向的第 3 期試驗結果，而且在 STARS extend 長期延伸研究中，我們持續看到改善幅度增加、PS 體積下降、停用 PS 的天數增加，甚至達成內在自主（internal autonomy），這點我們知道。

Is really critical for patients in this market who are burdened by the everyday demands of being on parental support. And when we look to, as Tom referenced in the presentation, peak US net sales of, greater than $700 million that assumes that there will be a lepid glutide, and at least one generic set of glutide on the marketplace. But even with that, we still believe in the potential to drive apraglutide to market leadership.

對於這個市場中每天承受腸外支持（parental support）需求負擔的病患而言，這是非常關鍵的。而當我們看向（如 Tom 在簡報中提到的）美國淨銷售峰值超過 7 億美元的假設時，這是建立在市場上會有 lepid glutide，以及至少一個 glutide 的學名藥進入市場。但即便如此，我們仍相信有潛力推動 apraglutide 成為市場領導者。

Through expanding utilization of GLP-2 therapies and improved adherence, and we don't anticipate that this would be a multi-source generic market because of a lot of the demands required for small patients. Size for rare disease and demands required to support these patients both clinically and from a reimbursement perspective. So full belief in the commercial opportunity and what glutide can do as a different differentiated agent within that market.

透過擴大 GLP-2 治療的使用，以及提升依從性；而且我們不預期這會是一個多來源學名藥市場，因為罕見疾病病患族群規模小，且在臨床支持與給付（reimbursement）面向上，支援這些病患需要滿足許多要求。罕見疾病病患規模，以及支援這些病患在臨床與給付面向所需的要求。因此，我們完全相信其商業機會，以及 glutide 作為該市場中一個具差異化的藥物所能帶來的價值。

(Operator Instructions).

(接線員指示)。

Dominic Rose, [Ian Health].

Dominic Rose，[Ian Health]。

Hi, and thanks for taking my questions. I've got two. My first question is, can you help us to understand what channel mix effects drove the LINZESS rebate in Q4 and whether we should expect ongoing volatility in pricing, this year.

嗨，謝謝讓我提問。我有兩個問題。第一個問題是，你們能否協助我們理解，Q4 是哪些通路組合（channel mix）效應導致 LINZESS 的回扣（rebate）變動，以及今年我們是否應預期定價仍會持續波動？

And my second question is that the LINZESS commercial volume looks to have fallen at the beginning of the year based on the data we can see. So can you tell us what your formerly positioning looks like in this year versus the prior year? Thank you.

第二個問題是，根據我們能看到的數據，LINZESS 的商業端銷量在年初似乎有所下滑。所以你們能否說明，今年相較於去年，你們的處方定位（formulary positioning）是什麼樣的情況？謝謝。

Thanks, Dominic. This is Greg. So fourth quarter pricing wasn't necessarily impacted by channel mix. It was really based on timing of recognition of gross to net rebate reserves. And in 2025, gross to net rebate reserves are based on units dispensed in the quarter.

謝謝你，Dominic。我是 Greg。所以第四季的定價不一定是受到通路組合影響。主要是因為總額到淨額（gross-to-net）回扣準備金（rebate reserves）認列時點的因素。而在 2025 年，gross-to-net 回扣準備金是以當季配藥（dispensed）的單位數為基礎。

So we had a higher volume of units dispensed in the fourth quarter relative to the units sold to wholesalers. So we saw a disproportionate impact from those gross to net rebates in the fourth quarter.

因此，第四季配藥的單位數相較於賣給批發商的單位數更高。所以我們在第四季看到這些 gross-to-net 回扣對結果造成不成比例的影響。

So it wasn't mixed. It was really timing of when those rebates were recognized. And if you look across the full year, it's really normalized from a timing perspective and you don't see a significant of an impact on the full year results as you did in first quarter and fourth quarter specifically, which were unfavorably impacted by that trend.

所以不是組合（mix）問題。而是這些回扣在何時被認列的時點問題。如果你看全年，其實從時點角度已經正常化，你不會像第一季與第四季那樣，在全年結果上看到那麼顯著的影響；第一季與第四季特別受到該趨勢的不利影響。

Moving forward in '26, we do not expect to have the same degree of volatility quarter over quarter. We do expect '26, will be a bit more consistent sequentially quarter over quarter than what we saw in 2025. And then from an overall, payer access, I'll have Tammy, talk to that in terms of 2026 coverage.

展望 2026 年，我們不預期季度之間會有同樣程度的波動。我們確實預期 2026 年會比 2025 年更一致，按季（sequentially）表現會更平穩。至於整體的付款方可近性（payer access），我請 Tammy 來談談 2026 年的給付覆蓋情況。

Yeah, so, as we've talked about already, of course, we, issued our full year guidance, which has both, significantly improved year over year due to a combination of improved net price as well as, low single-digit, anticipated low single-digit demand volume growth.

好的，所以，如同我們先前已談到的，當然，我們已發布全年指引，其中年對年顯著改善，主要來自淨價提升，以及預期低個位數的需求量成長。

So we have maintained a big part of our decision to lower the back was also to ensure patient access, and we have maintained broad patient access for LINZESS across our biggest books of business, both commercial and Medicare Part D, which was critical in this.

因此，我們維持（我們決定降低回扣的一大部分原因）也是為了確保病患可近性；而且我們已在 LINZESS 最大的業務組合中維持廣泛的病患可近性，涵蓋商業保險與 Medicare Part D，這在此非常關鍵。

And in terms of the low single-digit, we did expect Some impact on Medicaid as a percentage of business as states may decide to respond to the removal of the inflationary component of the statutory rebates, but we feel that we've taken the right approach for the guidance and continue to give patients branded prescription leading market access for LINZESS.

至於低個位數成長，我們確實預期 Medicaid 在業務占比上會受到一些影響，因為各州可能會因法定回扣中通膨組成被移除而做出回應；但我們認為我們在指引上採取了正確作法，並持續為病患提供 LINZESS 品牌處方在市場上領先的可近性。

I think the other question you had was the reduction in volume year over year and you know this this drug has been on a linear growth curve since we launched it and its remarkable what sustained growth we've seen. We do see some seasonality, in the first part of the year because of the high deducting plans that there's a reset.

我想你另一個問題是年對年銷量下滑；你知道，這個藥自上市以來一直呈線性成長曲線，而我們看到的持續成長相當令人驚訝。我們確實看到一年初期有一些季節性，因為高自付額（high deductible）方案會重置。

So we always, we generally always see in effect for the last 10 years we saw a reduction in the first quarter, first the prior fourth quarter, but then it accelerates through the year. So I think we're right on track from where we said we wanted to be, and we feel very good about, what the outlook for 2026, looks like.

所以我們一直——一般來說，過去 10 年我們都看到第一季相較於前一個第四季會下滑，但之後會在全年逐步加速。因此我認為我們的進度完全符合我們所說希望達到的位置，而且我們對 2026 年的展望感到非常樂觀。

Okay, thank you, that that's very helpful.

好的，謝謝，這非常有幫助。

Ladies and gentlemen, that concludes today's call.

各位女士先生，今天的電話會議到此結束。

Thank you all for joining. You may now disconnect.

感謝各位參與。您現在可以掛線。