Ironwood Pharmaceuticals, Inc. (IRWD) 2026 Q1 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 would like to welcome everyone to the Ironwood Pharmaceuticals first-quarter 2026 investor update conference call. (Operator Instructions)

感謝您的等候。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 2026 年第一季投資人最新進展電話會議。（接線員指示）

I would now like to turn the call over to Greg Martini, Chief Financial Officer. Please go ahead.

現在我想把電話交給財務長 Greg Martini。請開始。

Good morning and thank you for joining us for our first quarter 2026 investor update. Our press release issued this morning can be found on our website.

各位早安，感謝各位參加我們 2026 年第一季投資人最新進展說明會。我們今天早上發布的新聞稿可在公司網站上查閱。

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》所界定的前瞻性陳述。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, 2025 and in our subsequent SEC filings. All forward-looking statements speak as of the date of this presentation and we undertake no obligation to update such statements.

關於這些陳述與風險因素的討論，請參閱目前的安全港聲明投影片，以及我們截至 2025 年 12 月 31 日止年度的 Form 10-K 年報中「風險因素」章節，並參閱我們其後向 SEC 提交的文件。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 or superior to GAAP measures. 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.

本次亦包含非 GAAP 財務衡量指標，僅應作為 GAAP 指標的補充，而非替代或優於 GAAP 指標。在適用情況下，請參閱新聞稿末尾的表格，以取得這些指標與最直接可比 GAAP 指標之間的調節表。

During today's call, Tom McCourt, our Chief Executive Officer, will begin with a brief overview. Tammi Gaskins, our Chief Commercial Officer, will provide a commercial update, including discussion of the commercial opportunity for apraglutide in short bowel syndrome with intestinal failure. Mike Shetzline, our Chief Medical Officer, will discuss our pipeline and I will review our financial results and guidance. 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.

在今天的電話會議中，我們的執行長 Tom McCourt 將先做簡要概述。我們的商務長 Tammi Gaskins 將提供商業最新進展，包括討論 apraglutide 在伴隨腸衰竭之短腸症候群的商業機會。我們的醫務長 Mike Shetzline 將說明研發管線，而我將回顧財務結果與財測指引。今天的網路直播包含投影片，因此對於撥入的各位，請至我們網站的 Events（活動）專區另行取得隨附投影片。

With that, I'll turn the call over to Tom.

接下來，我把電話交給 Tom。

Good morning, everyone and thanks for joining us today to review our first quarter 2026 financial guidance results and business updates.

各位早安，感謝各位今天加入我們，一同檢視 2026 年第一季的財務指引結果與業務最新進展。

Earlier this year, we laid out our top priorities for 2026, which are maximizing LINZESS, advancing apraglutide and delivering sustained profits and cash flow. We believe these priorities are key to achieving our goals of redefining standard of care for patients suffering from GI and rare diseases, while maximizing shareholder value.

今年稍早，我們已提出 2026 年的首要重點：最大化 LINZESS、推進 apraglutide，以及實現持續的獲利與現金流。我們相信，這些重點是達成我們目標的關鍵：在為腸胃道（GI）與罕見疾病患者重新定義照護標準的同時，最大化股東價值。

During the first quarter, we made significant progress on each of these priorities. First, LINZESS, which continues to be the prescription leader for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation in its 14th year on the market. We reported an outstanding first quarter financial performance with 97% year-over-year net sales growth for LINZESS, driven primarily by improved net price and supported by 5% prescription demand growth.

第一季期間，我們在上述各項重點上都取得顯著進展。首先，LINZESS 在上市第 14 年，仍持續是治療便秘型腸躁症（IBS-C）與慢性特發性便秘（CIC）的處方領導品牌。我們公布了亮眼的第一季財務表現：LINZESS 淨銷售額年增 97%，主要由淨價格改善所帶動，並有 5% 的處方需求成長作為支撐。

These first quarter results position us well to achieve our full year 2026 financial guidance, which will return LINZESS to blockbuster status and will set a new all-time high for annual US net sales for the brand since launch.

第一季的結果使我們具備良好基礎以達成 2026 全年財務指引，這將使 LINZESS 重返「重磅藥」地位，並創下該品牌自上市以來美國年度淨銷售額的新高。

We are also continuing to make progress in bringing LINZESS to younger age groups. In the first quarter, the FDA accepted a supplementary new drug application for LINZESS for the treatment of functional constipation in patients two to five years of age. The application received a priority review with a PDUFA target action date set for May 24, 2026.

我們也持續推進將 LINZESS 擴展至更年幼年齡層。第一季，FDA 已受理 LINZESS 的補充新藥申請（sNDA），用於治療 2 至 5 歲患者的功能性便秘。該申請獲得優先審查，PDUFA 目標行動日期訂為 2026 年 5 月 24 日。

At present, LINZESS is the only FDA-approved drug for the treatment of children seven years and older with irritable bowel syndrome with constipation and for children 6 to 17 years old for functional constipation. If approved, the indication in children two to five years old for the treatment of functional constipation would further broaden the clinical utility of LINZESS in younger age groups and we look forward to hearing from the FDA in the coming weeks.

目前，LINZESS 是唯一獲 FDA 核准用於治療 7 歲及以上兒童便秘型腸躁症，以及用於 6 至 17 歲兒童功能性便秘的藥物。若獲核准，針對 2 至 5 歲兒童功能性便秘的適應症將進一步擴大 LINZESS 在更年幼族群的臨床效用，我們也期待在未來幾週收到 FDA 的回覆。

Also in the first quarter, we advanced our STARS-2 confirmatory Phase 3 clinical trial, assessing apraglutide for the treatment of patients with short bowel syndrome with intestinal failure, including completion of the clinical site feasibility and we remain on track for the clinical site initiation in the second quarter. This past weekend, we had a chance to present findings at Digestive Disease Week meeting in Chicago from the LANDMARK survey which underscores the need for therapies that address multiple dynamics and dimensions of the burden of total parenteral nutrition based on real-world experience of patients suffering from short bowel syndrome with intestinal failure. The survey identified reduction in days of total parenteral nutrition as the top priority for patients.

同樣在第一季，我們推進了 STARS-2 確認性第三期臨床試驗，評估 apraglutide 用於治療伴隨腸衰竭之短腸症候群（SBS-IF）患者，包括完成臨床試驗中心可行性評估；我們仍按計畫於第二季啟動臨床試驗中心。本週末，我們在芝加哥舉行的 Digestive Disease Week（DDW）會議上發表 LANDMARK 調查結果，該調查基於 SBS-IF 患者的真實世界經驗，凸顯需要能處理全靜脈營養（TPN）負擔之多重動態與面向的治療。調查顯示，減少全靜脈營養天數是患者的首要優先事項。

At DDW, we also presented additional data from the long-term extension study of apraglutide showing a long-term safety profile consistent with previous studies. Dr. Mike Shetzline, our Chief Medical Officer, will share more details of this data later in the call. Finally, in the first quarter, we delivered strong profits with $40.8 million in GAAP net income and $76.7 million in adjusted EBITDA. Looking ahead for the year, we believe the cash flows from LINZESS will continue to fund development and commercialization of apraglutide approved, while simultaneously reducing our debt.

在 DDW 上，我們也發表了 apraglutide 長期延伸研究的更多數據，顯示其長期安全性概況與先前研究一致。我們的醫務長 Mike Shetzline 醫師將在稍後的電話會議中分享更多細節。最後，在第一季，我們實現了強勁獲利：GAAP 淨利為 4,080 萬美元，調整後 EBITDA 為 7,670 萬美元。展望今年，我們相信 LINZESS 所帶來的現金流將持續支持 apraglutide 的研發與（若獲核准）商業化，同時降低我們的負債。

With that, I'll hand the call over to our Chief Commercial Officer, Tammi Gaskins, for a LINZESS commercial update and an overview of the opportunity in short bowel syndrome with apraglutide. Tammi?

接下來，我把電話交給我們的商務長 Tammi Gaskins，請她提供 LINZESS 的商業最新進展，並概述 apraglutide 在短腸症候群的機會。Tammi？

Thanks, Tom and good morning, everyone. As Tom highlighted, the first quarter US net sales of $272.5 million for LINZESS represent a 97% increase compared to the first quarter of 2025, driven by significantly improved net price and 5% year-over-year demand growth for LINZESS.

謝謝你，Tom，各位早安。如 Tom 所強調，LINZESS 第一季美國淨銷售額為 2.725 億美元，較 2025 年第一季成長 97%，主要由淨價格大幅改善所帶動，並伴隨 LINZESS 需求年增 5%。

Now I'd like to share some additional context from these results. To start, improved year-over-year net price in the first quarter of 2026 was driven primarily by two factors, first, net price benefited from elimination of inflationary rebates across channels, including Medicaid.

接下來我想就這些結果補充一些背景。首先，2026 年第一季淨價格的年對年改善主要由兩項因素驅動：第一，淨價格受惠於各通路（包括 Medicaid）通膨回扣的取消。

We expect that this benefit from reduced inflationary rebates to persist throughout 2026 as captured in our full year LINZESS US net sales guidance. The second factor that contributed to improved net price in the first quarter was favorable time phasing of gross to net rebate reserves as compared to the first quarter of 2025.

我們預期，通膨回扣降低所帶來的效益將在 2026 年全年持續，並已反映在我們對 LINZESS 美國全年淨銷售額的指引中。第二個促成第一季淨價格改善的因素，是相較於 2025 年第一季，總額到淨額（gross-to-net）回扣準備金的時間分布更為有利。

Looking ahead in 2026, we expect reduced variability in sequential quarterly LINZESS US net sales than occurred in 2025 as a result of more consistent net price across channels in 2026. Additionally, we recognized $104.2 million in US brand collaboration revenue in the first quarter of 2026, which represents a 169% increase compared to $38.8 million in the first quarter of 2025. So in just a minute, Greg will speak to additional first quarter 2026 financial results.

展望 2026 年，我們預期 LINZESS 美國淨銷售額的季度環比波動將較 2025 年更小，原因是 2026 年各通路的淨價格將更為一致。此外，我們在 2026 年第一季認列 1.042 億美元的美國品牌合作收入，較 2025 年第一季的 3,880 萬美元成長 169%。因此，稍後 Greg 將進一步說明 2026 年第一季的其他財務結果。

Now moving on from LINZESS's performance. I would like to spend a few minutes on the anticipated commercial potential of apraglutide for SBS-IF. For some context, SBS is a severe organ failure condition resulting from surgical resection of a significant portion of the small intestine, leading to a dependence on parenteral support to meet patients' nutritional needs for survival. And on average, SBS-IF patients require 10 hours a day, six days per week of parenteral support, with a severe quality of life burden.

接著從 LINZESS 的表現轉到下一個主題。我想用幾分鐘談談 apraglutide 在 SBS-IF 的預期商業潛力。先提供一些背景：SBS 是一種嚴重的器官衰竭狀況，源於手術切除小腸的相當大部分，導致患者必須依賴腸外營養支持以滿足維持生命所需的營養需求。平均而言，SBS-IF 患者每天需要 10 小時、每週 6 天的腸外支持，對生活品質造成沉重負擔。

Parenteral support meets patients' nutritional needs for survival but as highlighted by the LANDMARK survey, central line infections, fatigue, central line pain and abdominal pain are all common, highly distressing challenges associated with parenteral support, thereby underscoring the need for therapies to address multiple dimensions of total parenteral nutrition.

腸外支持可滿足患者維持生存所需的營養需求，但如 LANDMARK 調查所強調，中心靜脈導管感染、疲勞、中心靜脈導管疼痛以及腹痛，皆為與腸外支持相關的常見且高度令人痛苦的挑戰，因而凸顯需要能夠處理全靜脈營養（TPN）多重面向的治療。

Now data from the STARS Phase 3 clinical trial, which is the largest Phase 3 trial in SBS-IF conducted to date, demonstrated a twofold relative PS volume reduction from baseline at 24 weeks with apraglutide once weekly dosing as compared to placebo. Importantly, these longer-term data have demonstrated that more patients continue to lean off PS with longer exposure to apraglutide. In our Phase 3 long-term extension study called STARS Extend, approximately one in five or 20% of patients achieved enteral autonomy as of January 2025.

接著談到數據：迄今為止在 SBS-IF 中進行的最大型第 3 期試驗 STARS 第 3 期臨床試驗的數據顯示，與安慰劑相比，每週一次給藥 apraglutide 在第 24 週時可使腸外支持（PS）體積相對於基線降低兩倍。重要的是，這些較長期數據顯示，隨著 apraglutide 暴露時間延長，更多患者持續減少對 PS 的依賴。在我們名為 STARS Extend 的第 3 期長期延伸研究中，截至 2025 年 1 月，約每五位患者就有一位（約 20%）達到腸內自主（enteral autonomy）。

At DDW this week, we presented new data highlighting the long-term safety profile of apraglutide that was pooled from the STARS clinical program that includes the Phase 2 STARS Nutrition trial, STARS Phase 3 trial and the ongoing open-label extension STARS Extend. These data for apraglutide showed a long-term tolerability and safety profile consistent with previous studies, low discontinuation rates due to treatment-emergent adverse events and no new safety observations. Based on the clinical data generated to date, we believe that apraglutide has the potential to reduce volume and days on parenteral support for patients with SBS-IF.

本週在 DDW，我們發表了新的數據，重點呈現從 STARS 臨床計畫彙整而來的 apraglutide 長期安全性概況；該計畫包含第 2 期 STARS Nutrition 試驗、STARS 第 3 期試驗，以及正在進行的開放標籤延伸研究 STARS Extend。這些 apraglutide 數據顯示，其長期耐受性與安全性概況與先前研究一致，因治療期間出現不良事件（treatment-emergent adverse events）而停藥的比例偏低，且未觀察到新的安全性訊號。基於迄今產生的臨床數據，我們相信 apraglutide 具有降低 SBS-IF 患者腸外支持的體積與使用天數的潛力。

Now turning from data, let's look at the market size. We estimate that there are roughly 18,000 SBS-IF patients across the US, Europe and Japan. Within that patient population, we estimate that there are more than 8,000 patients in the US with SBS-IF who are dependent on parenteral support for three or more days a week. This group of patients dependent on parenteral support three or more days per week represents the total addressable SBS-IF market of more than $4 billion in the US.

從數據轉向市場規模。我們估計在美國、歐洲與日本合計約有 18,000 名 SBS-IF 患者。在該患者族群中，我們估計美國有超過 8,000 名 SBS-IF 患者每週需要腸外支持三天或以上。這一每週依賴腸外支持三天或以上的患者族群，代表美國可服務的 SBS-IF 總目標市場（TAM）超過 40 億美元。

Based on apraglutide's clinical profile and our market research, we believe that apraglutide has the potential to increase the number of GLP-2 treated patients extend days on therapy and achieve greater than $700 million in peak net sales in the US.

基於 apraglutide 的臨床特性與我們的市場研究，我們相信 apraglutide 有潛力提高接受 GLP-2 治療的患者人數、延長治療天數，並在美國達成超過 7 億美元的峰值淨銷售額。

With that, I'll turn the call over to Mike Shetzline, our Chief Medical Officer, to discuss apraglutide's ongoing clinical development. Mike?

接下來，我把電話交給我們的首席醫學官 Mike Shetzline，請他說明 apraglutide 目前進行中的臨床開發。Mike？

Thanks, Tammi and good morning, everyone. As you've heard today, we're very excited about the opportunity to help more patients with SBS-IF and have generated strong clinical data, some of which can be highlighted through our STARS and STARS Extend trials.

謝謝你，Tammi，各位早安。正如各位今天所聽到的，我們對於能協助更多 SBS-IF 患者的機會感到非常振奮，也已產生強勁的臨床數據，其中部分可透過我們的 STARS 與 STARS Extend 試驗加以呈現。

Over the past few months, we've made significant progress as we moved towards site initiation of our confirmatory Phase 3 trial, STARS-2, this quarter. STARS-2 is designed based on our interactions with the FDA to confirm and further support the positive data generated in the STARS Phase 3 clinical trial. We plan to enroll 124 patients with SBS-IF in a 1:1 randomization.

過去幾個月，我們在推進本季啟動確認性第 3 期試驗 STARS-2 的試驗中心啟動（site initiation）方面取得重大進展。STARS-2 的設計係基於我們與 FDA 的互動，旨在確認並進一步支持 STARS 第 3 期臨床試驗所產生的正面數據。我們計畫以 1:1 隨機分派納入 124 名 SBS-IF 患者。

Enrollment will be for the overall SBS-IF patient population, which includes patients with both stoma and colon-in-continuity. Our primary endpoint for the study will be the same as our prior STARS Phase 3 clinical trial, evaluating relative parenteral support volume change from baseline for the overall population at week 24.

收案將涵蓋整體 SBS-IF 患者族群，包括同時具有造口（stoma）以及結腸連續（colon-in-continuity）的患者。本研究的主要終點將與先前 STARS 第 3 期臨床試驗相同，評估在第 24 週時，整體族群相對於基線的腸外支持體積變化。

Secondary endpoints also to be measured at week 24 for the overall population include clinical response defined as a 20% reduction in parenteral support volume, number of days off parenteral support per week and enteral autonomy. In designing the Phase 2 trial, we've incorporated feedback from our prior FDA interactions and leveraged learnings from the positive STARS Phase 3 trial. In preparing for the STARS-2 trial, we've taken steps to refine and optimize the dose administration instructions.

同樣在第 24 週針對整體族群衡量的次要終點包括：臨床反應（定義為腸外支持體積降低 20%）、每週不需腸外支持的天數，以及腸內自主（enteral autonomy）。在設計第 2 期試驗時，我們納入先前與 FDA 互動所獲得的回饋，並運用 STARS 第 3 期試驗正面結果的經驗。在為 STARS-2 試驗做準備時，我們也採取措施精煉並最佳化劑量給藥指引。

A key consideration in designing STARS-2 was the dose selection, which we intended to confirm the efficacy and tolerability demonstrated in STARS with patients receiving 3.5 milligrams once weekly of apraglutide. We're getting close to initiating clinical trial sites in anticipation of dosing our first patient and look forward to providing additional updates as we continue to progress.

在設計 STARS-2 時的一項關鍵考量是劑量選擇；我們的目標是確認在 STARS 中，患者每週一次接受 3.5 毫克 apraglutide 所展現的療效與耐受性。我們已接近啟動臨床試驗中心，並為首位患者給藥做準備；隨著進展推進，我們也期待提供更多更新。

Before turning the call over to Greg, I'd like to take a few minutes to highlight our presence at DDW this week. As you've heard, we had the opportunity to present pooled long-term safety data on apraglutide as well as new findings from the LANDMARK survey in which surveyed providers emphasized the importance of reducing patients dependent on total parenteral nutrition or TPN, to improve quality of life, reduce line infections and lower the risk of thrombosis.

在把電話交給 Greg 之前，我想花幾分鐘重點說明我們本週在 DDW 的參與情況。如各位所聽到的，我們有機會發表 apraglutide 彙整的長期安全性數據，以及 LANDMARK 調查的新發現；在該調查中，受訪醫療提供者強調，降低依賴全靜脈營養（TPN）的患者比例，對於提升生活品質、降低導管感染並降低血栓風險的重要性。

About 46% of providers identified reducing the number of days per week on TPN as a priority attribute for further, for future therapies and an additional 30% prioritized reducing TPN hours per day. Survey results also highlighted the significant burden associated with long-term TPN dependence among patients with SBS.

約 46% 的醫療提供者認為，降低每週使用 TPN 的天數是未來治療的一項優先關鍵特性，另有 30% 則優先考量降低每日 TPN 的使用時數。調查結果亦凸顯 SBS 患者長期依賴 TPN 所帶來的重大負擔。

Our development strategy is informed by what we're hearing from patients in the medical community. The design of our STARS and STARS-2 clinical trials of apraglutide evaluate multiple dimensions of parenteral support dependence. These real-world insights from providers and patients will help us better target the outcomes that most impact SBS patient lives. Our strong presence at DDW this past week further highlights our commitment to developing life-changing therapies for people living with gastrointestinal and rare diseases through enhanced research and a deeper understanding of the challenges these patients face.

我們的開發策略係根據我們從醫療社群患者端所聽到的回饋而制定。apraglutide 的 STARS 與 STARS-2 臨床試驗設計，評估腸外支持依賴的多個面向。這些來自醫療提供者與患者的真實世界洞見，將協助我們更精準鎖定最能影響 SBS 患者生活的結果指標。我們在過去一週於 DDW 的強勢參與，也進一步凸顯我們透過強化研究與更深入理解患者所面臨挑戰，致力於為腸胃道與罕見疾病患者開發改變生命的療法。

With that, I'll turn it over to Greg to review our financial performance in the first quarter. Greg?

接下來，我把電話交給 Greg，請他回顧我們第一季的財務表現。Greg？

Thanks, Mike and good morning, everyone. I'm happy to walk through the highlights of our very strong first quarter financial performance, beginning on slide 12. In the first quarter, total revenue was $106.5 million. GAAP net income was $40.8 million and adjusted EBITDA was $76.7 million. We ended the first quarter of 2026 with $220.5 million of cash and cash equivalents on the balance sheet as well as $105.8 million in accounts receivable, which we expect to collect prior to the June 15 convertible note maturity.

謝謝你，Mike，各位早安。我很高興帶各位回顧我們非常強勁的第一季財務表現重點，從投影片 12 開始。第一季總營收為 1.065 億美元。GAAP 淨利為 4,080 萬美元，調整後 EBITDA 為 7,670 萬美元。我們在 2026 年第一季末，資產負債表上的現金及約當現金為 2.205 億美元，另有 1.058 億美元的應收帳款；我們預期在 6 月 15 日可轉換公司債到期日前收回該款項。

As noted in prior updates, we plan to use cash on hand and cash flows generated throughout 2026 to reduce our total debt balance and plan to repay the 2026 convertible note in cash at maturity in June. We also expect to end the year with approximately $300 million of total debt on the balance sheet, less than 1 times our expected 2026 adjusted EBITDA.

如先前更新所述，我們計畫運用手上現金以及 2026 年全年度所產生的現金流來降低總負債餘額，並計畫於 6 月到期時以現金償還 2026 年可轉換公司債。我們也預期年底資產負債表上的總負債約為 3 億美元，低於我們預期 2026 年調整後 EBITDA 的 1 倍。

Moving to financial guidance on slide 13. We are reiterating our 2026 guidance at this time. This includes LINZESS US net sales of between $1.125 billion and $1.175 billion. We continue to expect low single-digit percentage LINZESS prescription demand growth.

接著看投影片 13 的財務指引。我們目前重申 2026 年指引不變。其中包括 LINZESS 美國淨銷售額介於 11.25 億至 11.75 億美元。我們仍預期 LINZESS 處方需求將呈現低個位數百分比成長。

We expect Ironwood revenues of between $450 million and $475 million and we expect adjusted EBITDA of greater than $300 million. In summary, 2026 is off to a great start with strong LINZESS performance, a significantly improved financial position relative to 2025 and the impending initiation of the STARS confirmatory, STARS-2 confirmatory trial. We continue to make progress on executing on our strategic priorities as we strive to redefine the standard of care for patients living with GI and rare diseases.

我們預期 Ironwood 營收介於 4.50 億美元至 4.75 億美元之間，並預期調整後 EBITDA 高於 3.00 億美元。總結而言，2026 年開局良好，LINZESS 表現強勁，相較 2025 年財務狀況顯著改善，且 STARS 確證性試驗與 STARS-2 確證性試驗即將啟動。我們持續在執行策略優先事項方面取得進展，致力於為罹患腸胃道（GI）與罕見疾病的患者重新定義照護標準。

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

最後，我想感謝所有員工、患者、照護者與倡議者，大家共同致力於推動改變生命的療法。主持人，您現在可以開放提問。

(Operator Instructions)

（主持人指示）

Mohit Bansal, Wells Fargo.

Mohit Bansal，富國銀行。

Great, thank you very much for taking my question and Congrats on all the progress. So one question I have is on LINZESS. So LINZESS has been very strong in first quarter of '26 and wondering like so the volume growth and improved pricing, it does seem like a very strong quarter. So would love to understand like how, what is your thought process on the guidance given this quarter? Or is there any onetime item that we need to think about here?

很好，非常感謝讓我提問，也恭喜你們取得各項進展。我有一個關於 LINZESS 的問題。LINZESS 在 2026 年第一季表現非常強勁，無論是用量成長或價格改善，看起來都是非常亮眼的一季。想請教你們在看到這一季表現後，對於指引的思考邏輯是什麼？或者這裡是否有任何一次性因素需要我們納入考量？

Yes. Thanks, Mohit. I think overall, we're very encouraged by the first quarter results. Prescription demand, as you noted, 5% in the first quarter is slightly above our full year commentary on low single digits. That is a dynamic that we did anticipate the first quarter to be in line with our expectations that are factored into our overall full year guidance.

是的。謝謝你，Mohit。我認為整體而言，我們對第一季的結果感到非常振奮。正如你提到的，處方需求第一季成長 5%，略高於我們對全年「低個位數」的評論。這個動態我們確實有預期，第一季的表現符合我們的預估，且已反映在我們整體全年指引之中。

And from an overall brand performance and improved net price, I would say, again, first quarter was very much in line with our expectations. I think positions us very well for our full year guidance. And one dynamic that we called out in the prepared remarks is we don't expect the same fluctuation or volatility in quarterly net sales for the rest of this year as we saw in 2025. So I would expect more consistency in the quarterly phasing of LINZESS net sales for 2026, which puts us on a nice trajectory for the full year.

至於整體品牌表現與淨價格改善，我會說第一季同樣非常符合我們的預期。我認為這讓我們在達成全年指引方面處於非常有利的位置。我們在事先準備的發言中也提到一個因素：我們不預期今年剩餘期間的季度淨銷售額會像 2025 年那樣出現同等幅度的波動或不穩定。因此，我預期 2026 年 LINZESS 淨銷售額在季度節奏上會更一致，讓我們在全年走勢上處於良好軌道。

Very helpful. And if I may ask one on apraglutide as well. So I mean, in our chat at DDW, it does seem like there are a lot of patients who are on parenteral nutrition and the expert mentioned that about 70% of them probably could be on, could be SBS patients, SBS-IF patients. So in that context, first is like how underpenetrated the market is currently when you talk about GATTEX? And with the ICD-10 code and all, do you, how do you expect this to improve in terms of penetration of these GLP-2s in this market?

非常有幫助。如果可以的話，我也想問一個關於 apraglutide 的問題。我們在 DDW 的交流中，似乎有很多患者正在接受腸外營養，而專家提到其中約 70% 可能是 SBS 患者、SBS-IF 患者。在這樣的背景下，第一個問題是：就 GATTEX 而言，目前市場滲透率有多低？另外，隨著 ICD-10 代碼等因素，你們預期這會如何改善 GLP-2 類藥物在這個市場的滲透率？

Yeah. Tammy, do you want to come in on that?

好的。Tammy，你要不要回答這題？

Sure. Thanks for the question, Mohit. Just to sort of start at the top, as I mentioned in my remarks, we look at the total SBS population across US, Europe and Japan is about 18,000 patients. And then we've distilled that further based on research and the patient claims data codes that you've talked about to identify about 8,000-plus patients who we see as most likely to be prescribed a GLP-2 therapy as based on the definition of having, requiring parenteral support three or more days a week.

當然。謝謝你的問題，Mohit。先從整體來看，正如我在發言中提到的，我們估計美國、歐洲與日本的 SBS 總患者數約為 18,000 人。接著，我們再根據研究以及你提到的患者理賠資料代碼，進一步篩選出 8,000 多名我們認為最可能被處方 GLP-2 治療的患者，依據的定義是每週需要腸外支持三天或以上。

Now within that and the numbers that I referenced from a total addressable market of $4 billion, that's looking essentially at that 8,000 patients times the price that we know for the currently available therapy of GATTEX. Within that opportunity, today, we estimate based on public disclosures and available claims data that about 1,500 to 2,000 of those patients are on GATTEX at any given time. So there's still significant opportunity to increase GLP-2 utilization overall and we believe in the potential of a brand such as apraglutide to also help improve adherence or days on therapy to really optimize treatment for those patients.

在此基礎上，我所提到的 40 億美元總可服務市場（TAM）數字，基本上是以這 8,000 名患者乘上我們已知的、目前可用療法 GATTEX 的價格來估算。在這個機會中，我們目前根據公開揭露與可取得的理賠資料估計，任一時間點約有 1,500 至 2,000 名患者正在使用 GATTEX。因此，整體而言 GLP-2 的使用率仍有顯著提升空間；我們也相信像 apraglutide 這樣的品牌有潛力協助提升依從性或延長用藥天數，從而真正為患者優化治療。

Helpful. Thank you.

很有幫助。謝謝。

Amy Li, Jefferies.

Amy Li，Jefferies。

This is Kathy on for Amy. I just wanted to ask a quick question about your plans for life cycle management for LINZESS after LOE. So you've previously alluded to being able to pursue OTC for LINZESS. When can we get an update on that? And have you had any conversations with the FDA on any additional data that you would need to share?

我是代 Amy 提問的 Kathy。我想快速問一個關於 LINZESS 在專利到期（LOE）後的產品生命週期管理計畫。你們先前曾提到可能推動 LINZESS 轉為非處方藥（OTC）。我們何時能得到這方面的更新？以及你們是否已與 FDA 討論過需要補充或分享哪些額外資料？

Thanks, Katherine. Mike, do you want to take that one?

謝謝你，Katherine。Mike，你要不要回答這題？

Sure. It's a good question. I mean we've always been impressed with the performance of LINZESS and the availability of it for patients and we have a tremendously large safety database for LINZESS use. So we do think that the product has an opportunity for OTC. We have our ongoing engagement with AbbVie, our partner with a plan for OTC. We'll continue to do that and we look forward to updating you as we get more in the future.

當然。這是個好問題。我們一直對 LINZESS 的表現以及患者可及性印象深刻，而且我們擁有非常龐大的 LINZESS 使用安全性資料庫。因此，我們確實認為該產品具備轉為 OTC 的機會。我們正與合作夥伴 AbbVie 持續互動並制定 OTC 計畫；我們會繼續推進，也期待未來有更多進展時再向各位更新。

Jason Butler, Citizens JMP.

Jason Butler，Citizens JMP。

Hi, thanks for taking the questions. Just a couple on the STARS-2 trial. One, just a clarification point. Are you stratifying CIC and stoma patients in STARS-2? What's your expectation for the proportion of those patients, like two different populations that will enroll in the trial? And then just in terms of learnings from the first Phase 3 trial, how specifically when we think about operationally, what are you doing to make sure your enrollment time lines remain on track? And what's the overlap in sites versus what you used in the prior trial?

嗨，謝謝讓我提問。我有幾個關於 STARS-2 試驗的問題。第一個是釐清：在 STARS-2 中，你們是否會對 CIC（結腸連續性）患者與造口患者進行分層？你們預期這兩種不同族群在試驗中的入組比例大概會是多少？另外，就第一個第三期試驗的經驗而言，從營運執行角度，你們具體做了哪些事情來確保入組時程能維持在軌道上？以及本次試驗的研究中心與先前試驗使用的中心重疊程度如何？

Thanks, Jason. Mike?

謝謝你，Jason。Mike？

Yes. Thanks, Jason. So stratification is a good question. For the STARS-2 program, we're not formally stratifying. This was actually an outcome from our discussions with the agency. It's clearly recognized by the agency and prescribers that CIC, colon-in-continuity and stoma patients have a significant medical need and benefit from GLP-2 therapy.

是的，謝謝你，Jason。分層是個好問題。就 STARS-2 計畫而言，我們不會進行正式分層。這其實是我們與主管機關討論後的結果。主管機關與處方醫師都清楚認知，CIC（結腸連續性）與造口患者存在顯著未被滿足的醫療需求，且能從 GLP-2 治療中受益。

So in our study, our endpoints now, both primary and secondary are aligned with the overall population, which includes colon-in-continuity and stoma patients. However, we do need to show a benefit over the populations. So we'll actually track the recruitment of stoma and CIC patients. But again, to the point, there's no forced stratification but we'll align to get a representative group for both CIC and stoma patients as we discussed with the agency.

因此在我們的研究中，主要與次要終點現在都與整體族群一致，而整體族群包含 CIC 與造口患者。不過，我們確實需要在各族群中顯示療效。因此我們會追蹤造口與 CIC 患者的招募情況。但重點是：不會強制分層；我們會依照與主管機關的討論，確保納入 CIC 與造口患者的代表性樣本。

In regards to the operational execution, I think this SBS is a complex disorder and we certainly did an excellent job in the original STARS program operationally. As you know, that was a very robust, largest SBS-IF study ever performed. We had a very well-executed trial as demonstrated by the low placebo response and the 2 times, as Tammi highlighted, the twice benefit in terms of parenteral support volume reduction. So we're certainly leveraging that experience on the path forward to STARS-2 and we feel confident in our ability to execute STARS-2 as we did in the original STARS program. We'll continue to use sites we have used in the original trial.

至於營運執行方面，我認為 SBS 是一種複雜的疾病，而我們在原始 STARS 計畫的營運執行上確實做得非常出色。如你所知，那是迄今規模最大、最具代表性的 SBS-IF 研究。我們的試驗執行非常到位，從低安慰劑反應以及（如 Tammi 強調的）在腸外支持量減少方面達到兩倍效益即可看出。因此，我們一定會把這些經驗運用到推進 STARS-2 的過程中，並且對於能像原始 STARS 計畫一樣順利執行 STARS-2 充滿信心。我們也會持續使用原試驗中使用過的研究中心。

We're looking at all the sites carefully. As you know, this is a rare disease. So the number of patients per site is something we have to actively include. So we need to consider that in the calculus. But that's, as Tom mentioned, we did a lot of site feasibility already and we're taking those learnings into as we initiate sites and prepare to dose patients in the near term.

我們正在仔細審視所有的試驗中心。如各位所知，這是一種罕見疾病。因此，每個中心的病患數量是我們必須主動納入考量的因素，所以我們需要把這點納入整體評估。不過，正如 Tom 提到的，我們先前已經做了大量的中心可行性評估，並且在啟動中心、以及為近期開始對病患給藥做準備時，會把這些經驗教訓一併納入。

And I think the other piece there, the bottom line on this is, one, working with the sites where we know there are existing patients and we certainly have a track record there. But this is also opening up additional sites because this is all about recruiting patients as fast as we can. And we're certainly going to make the most of the sites we have relationships with but we've identified a number of additional sites that we believe we could also harvest patients from. So I think we're excited to get rolling on this and that will be initiated in the upcoming weeks.

我想另外一點，這件事的重點是：第一，與我們已知有既有病患的中心合作，而且我們在那裡確實有既往紀錄。但同時，這也意味著要開設更多中心，因為這一切都是為了盡可能快地招募病患。我們當然會充分利用與我們有合作關係的中心，但我們也已辨識出若干額外中心，我們相信也能從中招募到病患。所以我想我們很期待開始推進，並且將在接下來幾週內啟動。

Thank you.

謝謝。

Chase Knickerbocker, Craig Hallum.

Chase Knickerbocker，Craig Hallum。

Good morning. Thanks for taking the questions. Maybe just on guidance again, sorry, Tom or Greg, maybe just walk me through what went better than expected from a demand generation perspective in Q1? And then what are you keeping in mind or don't expect to recur to drive the decline in volume growth through the year that your guidance implies?

各位早安。謝謝讓我提問。想再回到指引，不好意思，Tom 或 Greg，能否帶我梳理一下，從第一季（Q1）的需求生成角度來看，哪些表現優於預期？另外，在你們的指引所暗示的情況下，全年銷量成長率將走低；你們在思考哪些因素，或有哪些你們不預期會再度發生、因而導致成長放緩的因素？

Yes. Thanks, Chase. This is Greg. So I think as we gave our initial guidance for 2026, we had commented to the low single-digit prescription demand growth and that is still our expectation for this full year. And part of the reason we had anticipated that we may see a slowing in growth relative to 2025 or prior years is, as we enacted this pricing change, we expected that there would be some response and impact to prescription demand.

好的，謝謝你，Chase。我是 Greg。我想我們在提供 2026 年初始指引時，曾提到處方需求成長為低個位數，而這仍是我們對全年（full year）的預期。之所以我們預期相較於 2025 或前幾年成長可能放緩，部分原因是：在我們實施這次定價變更時，我們預期處方需求會出現一些反應與影響。

But we were really focused on how we could maximize net sales overall over the remaining life cycle of brand. So we didn't expect that all of that would happen in the first quarter. We thought this would happen progressively throughout the year. And I would say Medicaid, in particular, is one of those areas that we would expect to potentially have reduced growth in the second half of 2026 or, for later portions. And so that's really what's factored into the guidance and where the 5% was more in line with expectations to start the year.

但我們真正聚焦的是，如何在品牌剩餘的整個生命週期中，最大化整體淨銷售額。因此，我們並不預期所有影響都會在第一季就發生；我們原本認為會在全年逐步發生。我會說，Medicaid（醫療補助）尤其是我們預期在 2026 年下半年或更後段期間，成長可能會降低的領域之一。因此，這些都已納入指引之中，而 5% 的表現更符合年初的預期。

Got it. Helpful. Maybe just on kind of gross to net through the year. Obviously, there's been quite a bit of change as far as the calculation there over the last 24 months. Can you just help us with how we should think about it sequentially, kind of balancing all the different drivers, including some of the dynamics later in the year with the redesign?

了解，很有幫助。再問一下關於全年毛利到淨額（gross-to-net）的走勢。顯然過去 24 個月在計算上有不少變化。你能否協助我們理解，按季（sequentially）應該如何看待它，在平衡各種不同驅動因素的同時，也包含今年稍晚因重新設計（redesign）帶來的一些動態？

Yes, absolutely. So I would say the biggest takeaway is full year, we feel very good about our overall forecast, the guidance we provided, which implies a more than 30% increase in net sales relative to 2025. I think to your point, there were quite a few fluctuations in net price throughout the quarters in 2025. In '26, we don't expect that same dynamic to occur because we now have more consistent or less variability in net price across channels.

可以，當然。我會說最大的重點是：就全年而言，我們對整體預測與所提供的指引非常有信心；該指引意味著相較 2025 年，淨銷售額將增加超過 30%。如你所說，2025 年各季度的淨價格確實有相當多波動。到了 2026 年，我們不預期會再出現同樣的動態，因為我們現在在各通路的淨價格更一致、或變動性更低。

So we do expect more consistent net sales in each quarter in '26 than occurred in 2025. From a growth rate perspective, the quarterly year-over-year comparisons could have some anomalies, I'd say, such as the 97% year-over-year in Q1. But from a dollar value, we expect more consistency in 2026.

因此，我們確實預期 2026 年各季度的淨銷售額會比 2025 年更一致。從成長率角度來看，季度的年對年比較可能會出現一些異常值（anomalies），例如第一季年對年 97%。但就金額而言，我們預期 2026 年會更一致。

Got it. And then just last for me on the expense side. $300 million on EBITDA is seeming like a pretty safe floor at this point. But is there any incremental expense kind of outside of STARS-2 that we should be considering that could kind of materially drive spend sequentially from here?

了解。最後一題，關於費用端。目前看起來 EBITDA 3 億美元像是相當安全的底線。但除了 STARS-2 之外，是否還有任何額外的增量費用需要我們留意，可能會在接下來按季實質推升支出？

Yes. So I think you hit on the key point. As we initiate activities associated with STARS-2, we do expect our R&D expenses will ramp up throughout the remainder of 2026. But to your point, we continue to believe we'll be able to deliver greater than $300 million of adjusted EBITDA for the year.

是的。我想你抓到重點了。隨著我們啟動與 STARS-2 相關的活動，我們確實預期 2026 年剩餘期間研發（R&D）費用會逐步上升。但如你所說，我們仍然相信全年可以交付超過 3 億美元的調整後 EBITDA。

Thanks, Ed.

謝謝你，Ed。

Thank you.

謝謝。

Tom Rosenfeld, Intron Health Research.

Tom Rosenfeld，Intron Health Research。

Good morning, everyone. Tom Rosenfeld, I am calling from Intron Health. My first one is, can you talk us through the magnitude of the opportunity to invest in functional constipation in two to five year-olds and whether you anticipate any material revenues from this label expansion in H2.

各位早安。我是 Tom Rosenfeld，來自 Intron Health。我的第一個問題是：你們能否說明在 2 到 5 歲功能性便秘（functional constipation）領域投資的機會規模？以及你們是否預期在下半年（H2）能從這項適應症擴增（label expansion）取得任何實質營收？

Yes. Thanks, Dominic (sic) [Tom]. I'm going to ask Tammi to speak to the opportunity we see with two- to five-year-olds pending an approval.

好的，謝謝你，Dominic（口誤）[Tom]。我請 Tammi 來談談我們在等待核准（pending an approval）的前提下，對 2 到 5 歲族群所看到的機會。

Yes. Thanks, Tom. First, we're very excited about the potential opportunity to extend, expand and offer a, potentially offer a prescription therapy for an additional pediatric patient population. We do expect that if approved, the two to five, will support additional demand for LINZESS overall but we still see the adult IBS-C, CIC population as the main driver of growth over the next few years. So yes, all these additional pediatric indications add to supporting demand but the real continued inflection will come from the adult population.

好的，謝謝你，Tom。首先，我們對於有機會延伸、擴大，並且（若獲核准）為額外的兒科病患族群提供一項處方治療，感到非常興奮。我們確實預期若獲核准，2 到 5 歲將能支持 LINZESS 整體的額外需求，但我們仍然認為成人 IBS-C、CIC 族群會是未來幾年成長的主要驅動力。所以，是的，這些額外的兒科適應症都有助於支撐需求，但真正持續的成長拐點將來自成人族群。

Thank you. That's really helpful. And one more question, if I may. So AbbVie's reimbursement for the Ironwood commercial expenses was down 90% this quarter versus the prior year. Is that around the right run rate we should assume going forward?

謝謝，這非常有幫助。如果可以的話我再問一題：AbbVie 對 Ironwood 商業費用的補償（reimbursement）本季較去年同期下降了 90%。這是否大致就是你們認為未來應假設的合理常態水準（run rate）？

Yes. So if you recall, in first quarter of 2025, we completed a restructuring of our organization, which reduced the Ironwood portion of the selling efforts for LINZESS. So I would say first quarter 2026 is more representative of a run rate for the remainder of this year in terms of those reimbursements.

是的。如果你還記得，在 2025 年第一季，我們完成了組織重整，降低了 Ironwood 在 LINZESS 銷售推廣工作中的占比。因此，我會說 2026 年第一季更能代表今年剩餘期間這些補償的常態水準。

Thank you very much.

非常感謝。

We have no further questions at this time. Ladies and gentlemen, that concludes today's call. Thank you all for joining. Let me now disconnect.

目前沒有其他問題。各位女士先生，今天的電話會議到此結束。感謝各位參與。現在我將中斷連線。