Ironwood Pharmaceuticals, Inc. (IRWD) 2026 Q2 法說會逐字稿

Good morning, everyone. My name is Ian, and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals Q2 2026 investor update conference call. (Operator Instructions)

各位早安。我叫 Ian，今天將擔任本次會議的電話會議主持人。此刻，我謹代表主辦方歡迎各位參加 Ironwood Pharmaceuticals 2026 年第二季投資人最新進展電話會議。（接線員指示）

I would like to now turn the call over to Chris Stamm, VP, Investor Relations and Communications. Please go ahead.

現在我想把電話會議交給投資人關係與企業傳播副總裁 Chris Stamm。請開始。

Good morning and thanks for joining our second quarter 2026 investor update. A press release issued this morning highlighting Q2 results can be found on our website. Today's call and accompanying slides include forward-looking statements within the meanings of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may cause actual results to differ materially. A discussion of these statements and risk factors is available on the current Safe Harbor slide as well as under the heading Risk Factors in our Annual Report Form 10-K for the year ended December 31, 2025, and in our subsequent SEC filings.

各位早安，感謝各位參加我們 2026 年第二季投資人最新進展說明。我們今早發布的新聞稿重點說明第二季業績，已可於公司網站查閱。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》所界定之「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前瞻性陳述存在重大差異。關於這些陳述與風險因素的討論，請參閱目前的「安全港」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，並參閱其後向 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. 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.

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之任何義務。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。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 GAAP 指標之調節表。

During today's call, Tom McCourt, our Chief Executive Officer, will review second quarter business highlights and strategic priorities. After Tom, Chief Commercial Officer; Tammi Gaskins will provide an overview of second quarter LINZESS performance. Next, Jeff Silber, our newly appointed Chief Medical Officer and Head of Research and Drug Development, will give a brief update on apraglutide. Then Ron Silver, our Interim Chief Financial Officer, will close our prepared remarks with a financial update before we open the call for questions. Jeff Ruberti, our Chief Strategy Officer, will also be available for the Q&A at the end of the call. Today's webcast includes accompanying slides. For those joining by phone, please visit the events section of our website to access the presentation.

在今天的電話會議中，我們的執行長 Tom McCourt 將回顧第二季業務重點與策略優先事項。Tom 之後，首席商務長 Tammi Gaskins 將概述第二季 LINZESS 的表現。接著，我們新任命的首席醫務長暨研究與藥物開發負責人 Jeff Silber 將就 apraglutide 提供簡要更新。然後，我們的臨時財務長 Ron Silver 將在開放提問前，以財務更新作為預先準備發言的結尾。我們的首席策略長 Jeff Ruberti 也將在會議末段的問答環節出席。今天的網路直播包含隨附投影片。透過電話加入的與會者，請造訪我們網站的活動（events）專區以取得簡報內容。

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

那麼，接下來我把電話會議交給 Tom。

Thanks, Chris. Thanks, everyone, for joining us to review Ironwood's second quarter 2026 financial results and business update. Before I begin, in addition to welcoming Chris, who joined the team in June to lead our IR and communications efforts, I'd like to introduce two recent additions to the Ironwood leadership team, who you'll be hearing more from today and in the weeks and months ahead.

謝謝你，Chris。也謝謝各位今天加入我們，一同回顧 Ironwood 2026 年第二季財務結果與業務更新。在我開始之前，除了歡迎 Chris（他於 6 月加入團隊，負責領導我們的投資人關係與企業傳播工作）之外，我也想介紹兩位近期加入 Ironwood 領導團隊的新成員，今天以及未來幾週、幾個月各位都會聽到他們更多分享。

But first, I want to sincerely thank former Chief Medical Officer and Head of R&D, Michael Shetzline, who retired after a distinguished career dedicated to advancing GI science and patient care. Most recently, he led the team through a major company milestone, successful initiation of the confirmatory Phase 3 STARS-2 trial.

但首先，我想由衷感謝前任首席醫務長暨研發負責人 Michael Shetzline；他在致力推動腸胃（GI）科學與病患照護的傑出職涯後已退休。最近，他帶領團隊達成公司一項重大里程碑：成功啟動確認性第三期 STARS-2 試驗。

Last month, we welcomed Dr. Jeff Silber, Mike's successor, who brings more than 30 years of experience in the industry and academia. Jeff is an accomplished leader in drug development from preclinical through submission, commercialization, and expanding value of brands through lifecycle management.

上個月，我們迎來 Mike 的接任者 Jeff Silber 醫師，他在產業與學界累積超過 30 年經驗。Jeff 是一位卓越的藥物開發領導者，具備從臨床前到送件、商業化，以及透過產品生命週期管理擴大品牌價值的完整經驗。

Previously Chief Medical Officer at Vedanta Biosciences, he brings broad late-stage development expertise to Ironwood, having supported multiple successful new drug applications and valuable brands in leadership roles at AbbVie, EMD Serono, Merck KGaA, and Merck & Co. His leadership will be instrumental as we advance apraglutide through Phase 3 and commercialization. I'd also like to introduce Ron Silver, our Senior Vice President, Corporate Controller, and Chief Accounting Officer, who is serving as Interim Chief Financial Officer. Ron has been with Ironwood for eight years, serving in key financial leadership roles, providing him with deep knowledge of our business and strategy. His experience and leadership will be invaluable as we continue to execute against our priorities.

他先前曾任 Vedanta Biosciences 首席醫務長，並在 AbbVie、EMD Serono、Merck KGaA 以及 Merck & Co. 擔任領導職務，支持多項成功的新藥申請與具價值的品牌，為 Ironwood 帶來廣泛的後期開發專長。他的領導力將在我們推進 apraglutide 進入第三期與商業化過程中扮演關鍵角色。我也想介紹 Ron Silver，他是我們的資深副總裁、公司財務控制長（Corporate Controller）暨首席會計長，目前擔任臨時財務長。Ron 已在 Ironwood 任職八年，擔任多項關鍵財務領導職務，對我們的業務與策略具有深厚了解。在我們持續落實各項優先事項之際，他的經驗與領導將極具價值。

Now, let's dive into the second quarter business updates. At the beginning of the year, we outlined three key priorities for 2026: maximizing the performance of LINZESS, advancing apraglutide, and delivering sustained profitability and cash flow. These priorities remain central to achieving our mission to redefine standard of care for patients living with gastrointestinal and rare disease while creating long-term shareholder value. During the second quarter, we made meaningful progress across each priority.

現在，讓我們進入第二季業務更新。在年初，我們提出 2026 年三項關鍵優先事項：最大化 LINZESS 的表現、推進 apraglutide，以及實現持續的獲利能力與現金流。這些優先事項仍是我們達成使命的核心：為腸胃道與罕見疾病患者重新定義照護標準，同時創造長期股東價值。在第二季，我們在各項優先事項上都取得了具體進展。

Starting with LINZESS, the brand continues to demonstrate exceptional strength in its 14th year on the market and remains the prescription leader in both irritable bowel syndrome with constipation and chronic idiopathic constipation. We're pleased to report a second consecutive quarter of strong LINZESS performance, delivering $282.3 million in US net sales fueled by improved net price and mid-single-digit prescription demand growth. This outstanding performance supported our decision to raise our full-year 2026 financial guidance.

先從 LINZESS 談起：該品牌在上市第 14 年仍展現非凡韌性，並持續在「便秘型腸躁症」與「慢性特發性便秘」兩個適應症中維持處方領導地位。我們很高興回報 LINZESS 連續第二季表現強勁，美國淨銷售額達 2.823 億美元，主要受惠於淨價提升以及處方需求中個位數（中段）成長。這項亮眼表現支持我們上調 2026 全年財務指引的決定。

Based on the updated outlook, LINZESS is positioned to grow more than 30% year-over-year, return to blockbuster status, and deliver the highest annual US net sales in the product's history. We also achieved an important regulatory milestone during the quarter, with the FDA approval of LINZESS for the treatment of functional constipation in pediatric patients two years of age and older. This is another important milestone, establishing LINZESS as the only prescription therapy approved for functional constipation in this age group, addressing yet another unmet patient need.

根據更新後的展望，LINZESS 有望年增超過 30%，重返重磅藥（blockbuster）地位，並創下該產品史上最高的年度美國淨銷售額。我們在本季也達成一項重要的法規里程碑：FDA 核准 LINZESS 用於治療 2 歲及以上兒科患者的功能性便秘。這是另一項重要里程碑，使 LINZESS 成為此年齡層唯一獲核准的功能性便秘處方療法，進一步滿足尚未被滿足的病患需求。

Turning to apraglutide, in June we initiated the STARS-2 confirmatory Phase 3 clinical trial evaluating apraglutide in adults with short bowel syndrome with intestinal failure, or SBS-IF. The trial is now actively recruiting patients, and we continue to activate additional sites to drive enrollment. STARS-2 will build on the positive data from the Phase 3 STARS trial, which we believe demonstrates that apraglutide has the potential to be a best-in-class therapy for patients with SBS who are dependent on parenteral support.

接著談 apraglutide：我們於 6 月啟動 STARS-2 確認性第三期臨床試驗，評估 apraglutide 用於患有伴隨腸衰竭之短腸症候群（SBS-IF）的成人患者。該試驗目前正積極招募患者，我們也持續啟用更多試驗中心以推動入組。STARS-2 將建立在第三期 STARS 試驗的正面數據之上；我們相信該數據顯示 apraglutide 具備成為同類最佳（best-in-class）療法的潛力，可用於需要依賴腸外營養支持的短腸症候群患者。

Our goal is to ensure apraglutide will be the first long-acting GLP-2 analog to market. Finally, we delivered strong financial results during the quarter, generating $51.3 million in GAAP net income and $83 million in adjusted EBITDA. We've also repaid our $200 million convertible notes at maturity with cash on hand. Looking ahead, we expect to leverage LINZESS generating cash flow to further reduce our debt, and we are well positioned to end 2026 with a gross leverage below 1 times, while maintaining resources necessary to advance and prepare for the potential commercialization of apraglutide.

我們的目標是確保 apraglutide 成為首個上市的長效型 GLP-2 類似物。最後，我們在本季交出強勁的財務成果：GAAP 淨利為 5,130 萬美元，調整後 EBITDA 為 8,300 萬美元。我們也已以手頭現金在到期時償還 2 億美元可轉換公司債。展望未來，我們預期將運用 LINZESS 所產生的現金流進一步降低負債；同時，在維持推進並為 apraglutide 潛在商業化做準備所需資源的前提下，我們有良好條件於 2026 年底將總槓桿降至 1 倍以下。

With that, I'll turn the call over to Tammi to provide some additional context on LINZESS. Tammi?

接下來，我把電話會議交給 Tammi，請她就 LINZESS 提供更多背景說明。Tammi？

Thanks, Tom, and good morning, everyone. As Tom just stated, LINZESS delivered another strong quarter with US net sales of $282.3 million. That's a 14% year-over-year increase driven by both demand growth and improved net price.

謝謝你，Tom，各位早安。如 Tom 剛才所說，LINZESS 再度交出強勁的一季，美國淨銷售額達 2.823 億美元。這代表年增 14%，主要由需求成長與淨價提升共同帶動。

Now, through the first half, LINZESS US net sales reached $555 million, up 44% year-over-year, underscoring the strength and momentum of the brand. Now, if I just double-click for a minute on demand, the slide you see shows year-on-year EUTRx volume growth of 4% for quarter two and 5% year-to-date June. We expect this demand momentum to persist and anticipate mid-single-digit demand growth for the full year, giving us the confidence to raise our full-year financial guidance.

目前，累計上半年，LINZESS 美國淨銷售額達 5.55 億美元，年增 44%，凸顯品牌的強勁實力與成長動能。接著我想用一點時間更深入談談需求，您在投影片上看到的是第二季 EUTRx 銷量年增 4%，以及截至 6 月的年初至今成長 5%。我們預期這股需求動能將持續，並預估全年需求將呈現中個位數成長，這也讓我們有信心上調全年財務指引。

Turning to price, the positive impact seen in Q1 from elimination of inflationary rebates across channels continued to benefit net price as planned, in addition to favorable timing of gross-to-net rebate reserves as compared to the second quarter of 2025. Our full-year net sales guidance reflects the ongoing benefit of improved net price, combined with anticipated reduced variability in sequential quarterly US net sales as compared to 2025, really due to more consistent net price across channels.

再來談價格方面，第一季因各通路取消通膨性回饋（rebates）所帶來的正面影響，依計畫在第二季持續挹注淨價格；此外，相較於 2025 年第二季，總額轉淨額（gross-to-net）回饋準備金的提列時點也更為有利。我們的全年淨銷售額指引反映了淨價格改善所帶來的持續效益，並結合我們對美國淨銷售額逐季波動將較 2025 年降低的預期，主要原因在於各通路的淨價格將更為一致。

To that end, since demand volume is historically highest in the second half of the year, we expect quarterly performance to build, with the fourth quarter projected to deliver the highest net sales for 2026. This performance also highlights the significant unmet needs that LINZESS helps to address for millions of patients with IBS-C and CIC across the US. And the recent FDA approval for FC, functional constipation, down to two years of age further expands the reach of LINZESS and helps highlight its importance for a broader range of patients.

因此，鑑於歷史上需求量在下半年最高，我們預期各季表現將逐步走高，並預估 2026 年第四季將貢獻全年最高的淨銷售額。這樣的表現也凸顯 LINZESS 在美國協助數百萬 IBS-C 與 CIC 患者滿足其龐大未被滿足需求的重要性。此外，近期 FDA 核准用於 FC（功能性便秘）且適用年齡下修至 2 歲，進一步擴大 LINZESS 的可及範圍，也突顯其對更廣泛患者族群的重要性。

Now I'd like to hand the presentation over to Jeff Silber to highlight our progress advancing apraglutide.

接下來我想把簡報交給 Jeff Silber，請他說明我們推進 apraglutide 的進展。

Thanks, Tammi, and good morning, everyone. I'm excited to be joining the Ironwood team at such an important time to work to bring apraglutide to patients suffering from SBS-IF as quickly as possible. Today, I'd like to share my perspective on why the science behind apraglutide and what it could mean for patients is so compelling. There's a considerable unmet need for patients with SBS-IF. On average, these patients require parenteral support, that is, 4 fluids and nutrients, 10 hours per day, 6 days per week, creating a real burden to their quality of life.

謝謝你，Tammi，各位早安。我很高興能在這個關鍵時點加入 Ironwood 團隊，盡可能快速地將 apraglutide 帶給罹患 SBS-IF 的患者。今天我想分享我對 apraglutide 背後科學依據的看法，以及它對患者可能代表的意義為何如此令人振奮。SBS-IF 患者存在相當大的未被滿足需求。平均而言，這些患者需要腸外支持（parenteral support），也就是每天 10 小時、每週 6 天輸注液體與營養，對其生活品質造成沉重負擔。

Although parenteral support meets the nutritional needs that enable them to survive, patients continue to face many significant daily challenges. As highlighted in the landmark HCP survey that Ironwood presented at DDW last May, central line infections, fatigue, central line pain, and abdominal pain are all common and highly distressing challenges associated with parenteral support.

雖然腸外支持能滿足其維持生命所需的營養需求，患者仍須面對許多重大的日常挑戰。如 Ironwood 去年 5 月在 DDW 發表的里程碑式醫護人員（HCP）調查所示，中心靜脈導管感染、疲勞、中心導管疼痛與腹痛，都是與腸外支持相關、常見且令人高度困擾的問題。

These findings underscore the need for therapies that reduce patients' IV dependence and the associated burden of parenteral support while improving their quality of life. One of the reasons I'm so excited to have joined Ironwood is the opportunity to help advance a therapy with the potential to address this significant unmet medical need.

這些發現凸顯了對治療的需求：在改善生活品質的同時，降低患者對靜脈輸注（IV）的依賴，以及減輕腸外支持所帶來的相關負擔。我之所以對加入 Ironwood 感到非常興奮，其中一個原因正是有機會推進一項具潛力解決此重大未被滿足醫療需求的療法。

First, apraglutide is currently the only once-weekly GLP-2 analog with positive Phase 3 efficacy and safety data in adults with SBS-IF. Data from the STARS study, the largest Phase III clinical trial in SBS-IF conducted to date, demonstrated significant reductions in parenteral support requirements compared with placebo at week 24, with treatment effects observed as early as week 8. As you can see in the graph on the left, at week 24 in the overall population, the reduction in weekly parenteral support volume in the apraglutide group was more than double that of the placebo group.

首先，apraglutide 目前是唯一一款每週一次給藥的 GLP-2 類似物，且在成人 SBS-IF 患者中擁有正向的第三期療效與安全性數據。迄今為止在 SBS-IF 領域規模最大的第三期臨床試驗 STARS 研究數據顯示，相較安慰劑，apraglutide 在第 24 週可顯著降低腸外支持需求，且治療效果最早在第 8 週即已觀察到。如左側圖表所示，在整體族群中，第 24 週時 apraglutide 組每週腸外支持量的降低幅度超過安慰劑組的兩倍。

In addition, a significantly greater proportion of patients receiving apraglutide were able to reduce their dependence on parenteral support by at least 1 day per week. Importantly, apraglutide was well-tolerated in the STARS study with an overall safety and GI tolerability profile that was similar to that of placebo. The graph on the right comes from our Phase 3 long-term extension study, STARS-Extend. About 90% of the patients enrolled in the STARS trial rolled over into STARS-Extend, and the majority remained on treatment at the time of the analysis shown here.

此外，接受 apraglutide 的患者中，有顯著更高比例能將其對腸外支持的依賴至少每週減少 1 天。重要的是，在 STARS 研究中 apraglutide 的耐受性良好，其整體安全性與腸胃道（GI）耐受性概況與安慰劑相近。右側圖表來自我們的第三期長期延伸研究 STARS-Extend。約 90% 參與 STARS 試驗的患者延續進入 STARS-Extend，且在此處所示分析時點，多數患者仍持續接受治療。

These longer-term data show that patients achieve further reductions in their parenteral support requirements with continued exposure to apraglutide. This translates into more patients achieving additional days off of parenteral support, with some reaching enteral autonomy, which is the ultimate goal for patients with SBS-IF.

這些較長期的數據顯示，隨著持續暴露於 apraglutide，患者的腸外支持需求可進一步降低。這代表有更多患者能獲得額外的「不需腸外支持」天數，其中部分患者可達到腸內自主（enteral autonomy），這也是 SBS-IF 患者的最終目標。

In fact, more than one in five patients enrolled in STARS-Extend had achieved enteral autonomy as of January. We look forward to sharing additional STARS-Extend updates in the future. The clinical profile we have observed to date reflects apraglutide's best-in-class, differentiated molecular design, differentiating it from both native GLP-2 and other GLP-2 analogs.

事實上，截至 1 月，STARS-Extend 中超過五分之一的受試者已達到腸內自主。我們期待未來分享更多 STARS-Extend 的更新結果。迄今觀察到的臨床特徵反映了 apraglutide 同級最佳（best-in-class）、具差異化的分子設計，使其有別於天然 GLP-2 以及其他 GLP-2 類似物。

Apraglutide is long-acting, enabling convenient once-weekly dosing, and it's demonstrated a favorable tolerability profile that may support better treatment adherence. This is an important point because maintaining patients on therapy is a key factor in achieving full treatment benefit, including meaningful and sustained reductions in parenteral support.

Apraglutide 具長效特性，可提供便利的每週一次給藥，並已展現良好的耐受性概況，可能有助於提升治療依從性。這點非常重要，因為讓患者持續接受治療是達成完整治療效益的關鍵因素之一，包括在腸外支持方面達到具臨床意義且可持續的降低。

When you put all this together, the clinical evidence, the favorable tolerability, and the convenience of once-weekly dosing, we believe that apraglutide has the potential to become the preferred GLP-2 treatment option for patients with SBS-IF, which we expect to expand the number of patients who may benefit from GLP-2 therapy. Looking into the future, a uniquely differentiated GLP-2 analog like apraglutide has the potential to restore intestinal function in patients with other types of GI compromise beyond SBS-IF.

綜合以上—臨床證據、良好的耐受性，以及每週一次給藥的便利性—我們相信 apraglutide 有潛力成為 SBS-IF 患者首選的 GLP-2 治療選項，並可望擴大可能受益於 GLP-2 治療的患者人數。展望未來，像 apraglutide 這樣具獨特差異化的 GLP-2 類似物，亦有潛力在 SBS-IF 之外，協助其他類型腸胃道（GI）功能受損的患者恢復腸道功能。

Today, however, our top priority is advancing apraglutide to patients with SBS-IF as quickly as possible. And to that end, the confirmatory Phase 3 STARS-2 trial was initiated in June as planned and is now actively recruiting patients. STARS-2 is a 24-week global randomized double-blind placebo-controlled trial. The primary endpoint is relative change from baseline in actual weekly parenteral support volume at week 24. As we continue to add clinical trial sites, we'll be leveraging the infrastructure and the relationships that we developed during the conduct of the STARS study.

不過就目前而言，我們的首要任務是盡可能快速地將 apraglutide 推進至 SBS-IF 患者。為此，確認性第三期 STARS-2 試驗已如期於 6 月啟動，目前正積極招募患者。STARS-2 為一項為期 24 週的全球性隨機、雙盲、安慰劑對照試驗。主要終點為第 24 週時，實際每週腸外支持量相對於基線的變化幅度。隨著我們持續新增臨床試驗據點，我們將運用在執行 STARS 研究期間建立的基礎設施與合作關係。

As a reminder, the Phase 3 STARS study was the largest SBS-IF trial conducted to date, with 68 global sites. We're building on that strong foundation, leveraging those existing site relationships and adding new high-potential sites, including more sites in the US, and identifying opportunities to accelerate enrollment. Successful execution of STARS-2 remains one of our highest priorities for Ironwood. And site activation continues. We expect enrollment to build, and we're evaluating opportunities to accelerate the enrollment timeline.

提醒一下，第三期 STARS 研究是迄今規模最大的 SBS-IF 試驗，涵蓋 68 個全球據點。我們將在此堅實基礎上再接再厲，運用既有的據點合作關係並新增具高潛力的新據點，包括在美國增加更多據點，同時尋找加速收案的機會。成功執行 STARS-2 仍是 Ironwood 最優先事項之一。而據點啟動工作仍在持續進行。我們預期收案將逐步加速，並正在評估縮短收案時程的機會。

We look forward to updating you on our progress in the coming months. In summary, if approved, we believe apraglutide's differentiated clinical profile, once-weekly dosing, and long-term data position it to meaningfully improve the treatment landscape for patients with SBS-IF.

我們期待在未來幾個月向各位更新我們的進展。總結而言，若獲核准，我們相信 apraglutide 具差異化的臨床特徵、每週一次給藥，以及長期數據，將使其有能力實質改善 SBS-IF 患者的治療格局。

With that, I'll pass the call to Ron.

接下來我把電話會議交給 Ron。

Thanks, Jeff. Thanks, Tom, for the introduction. I'm pleased to have the opportunity to join the call today and look forward to working closely with our investors and analysts as we continue to advance our strategic priorities, focus on financial discipline and operational excellence.

謝謝你，Jeff。也謝謝你，Tom，做開場介紹。我很高興今天能加入這通電話會議，並期待在我們持續推進策略重點、專注於財務紀律與營運卓越的同時，與投資人及分析師密切合作。

Turning to our financial results. During the second quarter, total revenue was $113 million, GAAP net income was $51 million, and adjusted EBITDA was $83 million. We ended the quarter with $79 million in cash and cash equivalents and $113 million in collaboration receivables. As Tom mentioned, we repaid our convertible notes at maturity in June. Looking ahead, we intend to continue using operating cash flows to further reduce our debt balance.

接著談我們的財務表現。第二季總營收為1.13億美元，GAAP淨利為5,100萬美元，調整後EBITDA為8,300萬美元。季末我們持有7,900萬美元的現金及約當現金，以及1.13億美元的合作應收款。如Tom所提到，我們已於6月到期時償還可轉換公司債。展望未來，我們打算持續運用營運現金流，進一步降低債務餘額。

Based on our current outlook, we expect to end the year with less than $300 million of gross debt outstanding, further strengthening our balance sheet and financial flexibility. Now turning to guidance. Given the continued strength of LINZESS and our very strong first half performance, I am pleased to share that we are increasing our full year of 2026 guidance. We now expect LINZESS US net sales of between $1.15 billion and $1.20 billion, representing a greater than 30% increase year-over-year.

依據我們目前的展望，我們預期年底未償還的總負債將低於3億美元，進一步強化資產負債表與財務彈性。接著談財測指引。鑑於LINZESS持續強勁，以及我們上半年非常亮眼的表現，我很高興宣布我們上調2026全年指引。我們目前預期LINZESS美國淨銷售額介於11.5億至12.0億美元之間，年增幅超過30%。

This increase is driven by significantly improved net price and mid-single-digit LINZESS prescription demand growth. Our revenue guidance has increased to between $460 million and $485 million, and we expect adjusted EBITDA of greater than $310 million. This increase in our guidance reflects both the strength of our underlying business and our confidence in continued execution on our priorities throughout the remainder of the year.

這項上調主要由淨價格顯著改善，以及LINZESS處方需求呈現中個位數成長所帶動。我們的營收指引上調至4.60億至4.85億美元，並預期調整後EBITDA將高於3.10億美元。此次上調反映了我們核心業務的強勁動能，以及我們對於在今年剩餘期間持續落實各項優先事項的執行力充滿信心。

Now I'd like to turn the call back over to Tom for some closing remarks.

接下來我想把電話交回給Tom，請他做一些結語。

Thanks, Ron. In summary, the second quarter was marked by strong commercial execution of LINZESS, continued advancement of apraglutide with the initiation of STARS-2, and meaningful progress towards strengthening our balance sheet. Throughout the second half of the year, we will remain laser-focused on executing on our strategic priorities and advancing our vision to redefine standard of care for patients living with GI and rare disease.

謝謝你，Ron。總結來說，第二季的重點包括LINZESS商業執行強勁、apraglutide隨著STARS-2啟動而持續推進，以及在強化資產負債表方面取得具體進展。在下半年，我們將持續高度聚焦於執行策略優先事項，並推進我們的願景：為腸胃道（GI）與罕見疾病患者重新定義照護標準。

Before I turn it over to Q&A, I would like to thank our employees, patients, caregivers, investigators, and advocacy partners for their continued commitment and support. Operator, we're now ready to open up the line for questions.

在進入問答之前，我想感謝我們的員工、病患、照護者、研究人員以及倡議夥伴持續的投入與支持。接線員，我們現在可以開放提問。

(Operator Instructions)

(接線員指示)

Jason Butler from Fergusons.

來自Fergusons的Jason Butler。

Hey, it's Jason Butler from Citizens. Thanks for taking the questions. Just a couple for me. First, I know one question at the beginning of the year was, would there be an impact on demand from the net price change? It seems like you have an increased comfort level that isn't going to happen now, even on a delayed basis. Can you just walk us through those dynamics?

嗨，我是Citizens的Jason Butler。謝謝讓我提問。我這邊有兩個問題。第一個，我知道年初有個問題是：淨價格變動是否會對需求造成影響？看起來你們現在更有把握這不會發生，即使是延後才顯現也不會。可以請你們帶我們梳理一下其中的動態嗎？

Hi, Jason, it's Tammi. Appreciate the question. So as I stated, through June we are tracking to 5% year-to-date EUTRx volume demand growth, which is modestly ahead of what we had shown or indicated early in the year, which was low single-digit demand growth.

嗨，Jason，我是Tammi。謝謝你的問題。如我先前提到，截至6月，我們年初至今的EUTRx量需求成長為5%，略高於我們年初所呈現或所指引的低個位數需求成長。

And based on where we are in the year and the fact that historically our performance from a demand perspective even further increases in the second half of the year, that has given us the confidence and the belief to raise the demand number to mid-single-digit. We did indicate previously that we thought there could be some demand softening due to the elimination of the inflationary rebates across channels. We've done a lot working with our partner to really help ensure ongoing access for patients across channels, and we think we're in a very good spot now to deliver in that mid-single-digit range to the full year.

而且基於我們目前的年度進度，以及歷史上從需求面來看我們在下半年通常還會進一步走強，這讓我們更有信心、也更相信可以把需求成長的數字上調到中個位數。我們先前確實提到，因為跨通路取消通膨型回扣（inflationary rebates），需求可能會有些轉弱。我們與合作夥伴做了大量工作，以確保病患在各通路的持續可近性（access），我們認為目前處於非常好的位置，能在全年達成中個位數的成長區間。

Great. And then second one for me just starts to understand you're still relatively early here in the trial, but can you just walk us through how site onboarding is going and then just the comments you made about potentially impacting or improving enrollment timelines. Can you just give us a little more detail about what your strategies could be there? Thank you.

很好。第二個問題是，我了解試驗目前仍相對早期，但能否請你們說明一下研究中心（site）導入/啟用的進展，以及你們提到可能影響或改善入組（enrollment）時程的評論。可以再多提供一些你們可能採取的策略細節嗎？謝謝。

Yes, absolutely, Jason. This is Jeff Ruberti. I'll open the response, but as you noted, it's early days. We initiated the trial in June and we have our first sites activated and enrolling patients. And the full weight of the company is really pressing behind, ramping up the trial, activating more sites, and we look forward to providing more operational details.

好的，當然可以，Jason。我是Jeff Ruberti。我先回應，不過如你所說，目前還在早期階段。我們在6月啟動試驗，已經有第一批研究中心完成啟用並開始招募病患。公司正全力推動試驗加速，包括擴大啟用更多研究中心；我們也期待後續提供更多營運層面的細節。

As you noted, Jeff Silber just joined the team and it is a priority as well. And Jeff, do you want to comment on how can we accelerate the timeline?

如你所提到，Jeff Silber剛加入團隊，這也是一項優先事項。Jeff，你要不要談談我們如何加速時程？

Sure. It's week three and so, I am working with the team and what's impressed me so far is the diligence with which the team is executing on the plan that had been laid out over the last several months. I am just now beginning to look through this with a fine-tooth comb. We'll be looking for opportunities to accelerate and look forward to executing optimally on the plan that had already been developed.

當然。目前是第三週，所以我正在與團隊合作；到目前為止讓我印象深刻的是，團隊以非常嚴謹的態度在執行過去幾個月所擬定的計畫。我現在才剛開始用放大鏡逐項檢視。我們會尋找可加速的機會，並期待以最佳方式執行既有已制定的計畫。

Yes, I think the big thing here, Jason, is really the expansion of the number of sites, particularly in the US where we were with STARS. As you recall, there wasn't a lot of US sites. It was largely ex-US. And we see a real opportunity here. And obviously that's building off real strong support from our steering committee -- scientific steering committee, who are a lot of the key investigators around the country, and also our ability to identify high-potential sites where there clearly is or we know there are patients that exist.

是的，我想這裡最大的重點，Jason，是擴大研究中心的數量，特別是在美國，因為我們在STARS時期的配置是那樣。如你所記得，當時美國的研究中心不多。主要是在美國以外地區。而我們在這裡看到很大的機會。當然，這也建立在我們指導委員會——科學指導委員會——的強力支持之上，他們是全國許多關鍵研究者；同時也仰賴我們辨識高潛力研究中心的能力，在那些地方確實存在、或我們知道有病患可納入。

And I think with our trial design and combining that with the clinical profile of the drug, we're pretty confident that we're going to be able to bring in a number of patients fairly quickly. But obviously, we'll be updating you and the rest of the investment community as we progress through that process.

我認為，結合我們的試驗設計以及藥物的臨床特性，我們相當有信心能在相對短的時間內納入一定數量的病患。不過很明顯地，隨著我們推進該流程，我們會持續向你以及其他投資人社群更新進度。

Mohit Bansal, Wells Fargo.

Wells Fargo的Mohit Bansal。

Great. Thank you very much for taking my questions, and congrats on all the progress. So I have two questions, one on apra and one on LINZESS. So there was some -- so for LINZESS, there was some concern around like -- could there be some plans they could have an issue given the price is higher now? Are you seeing anything like that in the Medicaid patient population? So far, it doesn't seem like that, but we'd love for you to touch upon that.

很好。非常感謝讓我提問，也恭喜你們取得各項進展。我有兩個問題，一個關於apra，一個關於LINZESS。關於LINZESS，之前有一些擔憂——例如：在價格現在更高的情況下，是否有些保險計畫可能會出現問題？你們在Medicaid病患族群中有看到類似情況嗎？目前看起來似乎沒有，但希望你們能談一下。

And then for apra, so now that you are expanding to newer sites and all that, how do you make sure that trial conduct issues last time when people did not dose properly, how do you ensure that repeat of that doesn't happen as you go into more sites here?

另外關於apra，既然你們正在擴展到新的研究中心等等，上次有人沒有正確給藥而導致的試驗執行問題，你們要如何確保在這次擴點後不會再次發生？

Tammi, do you want to take the first question on this?

Tammi，你要不要先回答第一個問題？

Yes, sure. Hi, Mohit. It's Tammi, and I appreciate the question. So, you're absolutely correct in that before we had talked about, and part of the reason we indicated low single-digit demand growth at the beginning of the year is through the elimination of the inflationary rebates across channels, including Medicaid, we thought there could be some demand softening.

好的，當然。嗨，Mohit。我是Tammi，謝謝你的問題。你說得完全正確：我們之前確實談過，而我們在年初之所以給出低個位數需求成長的部分原因，是因為跨通路取消通膨型回扣（inflationary rebates），包括Medicaid在內，我們認為需求可能會有些轉弱。

But based on where we are at the year, the 5%, and the fact that we have done, as I mentioned, a lot with our partners, to work with the states individually to help ensure ongoing access to those patients, we are now very confident in that mid-single-digit expectation for that mid-single-digit demand growth through the rest of the year, especially since historically our demand has a bit of a seasonality and increases towards the latter half for the year, especially in Q4.

但基於我們目前在年度中的進度、5%的表現，以及如我所提到我們已與合作夥伴做了大量工作、逐州與各州合作以協助確保這些病患能持續取得治療，我們現在對於今年剩餘期間維持「中個位數」的預期、也就是中個位數的需求成長，感到非常有信心。尤其是因為從歷史上看，我們的需求帶有一些季節性，並會在下半年增加，特別是在第四季。

Just to be clear on kind of this issue or concern that we had at dose. As you recall, with the original trials, the STARS trial, the intent was to deliver a 5-milligram dose. Unfortunately, due to the kit and the instructions, what we actually saw was a delivery of 3.5 milligram.

為了釐清我們在劑量方面的這個議題或疑慮。如各位所記得，在最初的試驗、也就是STARS試驗中，原本的意圖是給予5毫克的劑量。不幸的是，由於套組與使用說明的原因，我們實際觀察到的給藥量是3.5毫克。

Now, clearly the drug worked and was extremely well-tolerated, even at 3.5 milligram. So what we wanted to do was match that so we could leverage the great data of STARS with this smaller confirmatory dose. Now, what we've done since then, based on the root cause analysis on the delivery, we've dramatically improved the kit to avoid any kind of errors in instruction or implementation of the new kit.

很明顯地，即使在3.5毫克的劑量下，藥物仍然有效且耐受性極佳。因此我們想做的是把它對齊，以便能用較小的確認性劑量來運用STARS的優異數據。自那之後，基於對給藥問題的根因分析，我們已大幅改良套組，以避免在說明或新套組執行上出現任何錯誤。

And we've done several human factors studies around that. We've also done drug exposure and pharmacokinetic data. So we're absolutely confident that we're in complete control of the dose and we're absolutely confident that this error will not happen in STARS-2. So I think moving forward, we see a very, very high probability of success to reconfirm the great data we saw in the original STARS trial.

我們也針對此進行了多項人因研究。我們也做了藥物暴露量與藥動學數據分析。因此我們完全有信心能夠全面掌控劑量，也完全有信心這個錯誤不會在STARS-2中發生。所以我認為展望未來，我們有非常、非常高的成功機率，能重新確認我們在原始STARS試驗中看到的優異數據。

(Operator Instructions)

(接線員指示)

Dominic Rose, Intron Health.

Dominic Rose，Intron Health。

Hi, this is Dominic from Intron Health. Thanks for taking my questions. I've got two. My first question is both Q1 and Q2 saw favorable time phasing of gross-to-net rebate reserves. Do we expect this to unwind in H2 or would there be more favorable moves? Is there anything you can tell us about that? And my second question is in May you flagged that Medicaid would be most likely seeing reduced volume growth in H2. Is that still your expectation now, given the guidance upgrade?

嗨，我是Intron Health的Dominic。謝謝讓我提問。我有兩個問題。第一個問題是，第一季與第二季的總額到淨額（gross-to-net）回扣準備金在時間分攤上都出現有利的變化。我們是否預期這會在下半年回轉（unwind），還是會有更多有利變動？你們能否就此提供一些說明？第二個問題是，你們在5月曾提到Medicaid在下半年最可能出現量的成長放緩。在上修指引之後，這仍是你們目前的預期嗎？

Thanks, Dominic. Tammi, do you want to take both of those?

謝謝你，Dominic。Tammi，你要不要兩個都回答？

Sure. I appreciate the question. This is Tammi. So, to start with the favorability of phasing of gross-to-net reserves, so first as I indicated in my comments, we do expect less variability in sequential quarterly net sales this year. We had quite a bit of variability last year because there was -- for two key reasons.

好的。謝謝你的提問。我是Tammi。先從總額到淨額準備金分攤的有利因素談起：首先，如同我在發言中提到的，我們確實預期今年各季之間的淨銷售額波動會比較小。去年我們的波動相當大，主要有——兩個關鍵原因。

One, there was more difference in net price across channels. And because of accruing rebates relative to actual demands dispensed in a quarter, that variability in price had more of a variability because of seasonality of certain sectors of the business.

第一，不同通路之間的淨價格差異更大。而且由於回扣提列是相對於當季實際配藥需求（dispensed）的情況，價格的差異會因為業務某些區塊的季節性而造成更大的波動。

So this year, more consistent net price across channels, not be affected nearly to the extent of the seasonality and actual units dispensed, but also, we expect to see quarter-on-quarter increase in performance with Q4 actually being the strongest quarter that we'll have this year from a net sales perspective. So in key takeaway, don't expect there to be an unwinding, if you will, due to changes in favorability quarter-on-quarter.

但今年，各通路的淨價格更一致，受季節性與實際配藥單位數影響的程度會小得多；此外，我們也預期每一季的表現會季對季提升，而從淨銷售額角度來看，第四季將會是今年最強的一季。所以重點結論是：不要預期會因為各季有利因素變動而出現所謂的回轉（unwinding）。

And the anticipated reduction for Medicaid volume?

那Medicaid量的預期下降呢？

Yes. So, as I said, we saw strong 5% demand growth through mid-year. We've worked very hard at a state level with our payer to help maintain access across channels, including Medicaid, and we are still projecting to have our growth across channels to be in line with expectations to drive that mid-single-digit demand growth through the full year.

是的。如我所說，我們在年中之前看到強勁的5%需求成長。我們在州層級與付款方非常努力合作，以協助維持各通路（包括Medicaid）的可近性，而我們仍預估各通路的成長將符合預期，推動全年維持中個位數的需求成長。

So, bottom line, Tammi, I think where we're at is we're not seeing the dramatic reduction in Medicaid that we thought we were at risk of. So, you know, I think we feel very good about the current trend we're on with regard to volume as well as net price.

所以，總結一下，Tammi，我想我們目前看到的是：並沒有出現我們原先擔心可能面臨的Medicaid大幅下滑。因此，就量以及淨價格而言，我們對目前的趨勢都感到非常良好。

And we expect more consistent sequential quarterly net sales growth continue to improve performance each quarter throughout the end of the year, with fourth quarter being our strongest performer.

而且我們預期各季之間的淨銷售額成長會更一致，並在年底前每一季持續改善表現，其中第四季將是我們表現最強的一季。

Chase Knickerbocker, Craig-Hallum.

Chase Knickerbocker，Craig-Hallum。

Good morning. Thanks for taking the questions. Maybe just on LINZESS net sales guidance. The high end of the range went up by a higher magnitude than the bottom. Just trying to understand the edge caps -- the end caps on the guidance there. Is it a little bit of conservatism just as far as kind of IRA rebates in the back half as far as the bottom end of the range? Or just maybe kind of help me understand both sides.

早安。謝謝讓我提問。我想先問LINZESS淨銷售額指引。區間上緣上調的幅度似乎比下緣更大。我想了解一下你們指引區間兩端的「端點」設定。下緣是否是因為對下半年IRA回扣有些保守考量？或是能否幫我理解一下兩端各自的考量？

Hi, Chase. The increase in the guidance was actually consistent on each end of the range. It was up by $25 million. I think the major driver of the confidence to raise that guidance was the single-digit demand, which we've seen now, it's only two quarters in a row. So give us confidence we'll be able to land in that range. But just to reiterate, the range was improved consistently across both ends.

嗨，Chase。指引的上調其實在區間兩端是一致的。兩端都是上調2,500萬美元。我認為讓我們有信心上調指引的主要驅動因素，是我們目前看到的個位數需求表現，而且這已經連續兩季了。因此讓我們有信心能落在該區間內。但再重申一次，區間兩端都是一致地改善。

Understood. And then just as we think about, you know, the EBITDA guidance on the year. Any additional kind of color you can give us as far as kind of how we should be thinking about kind of R&D progressing in Q3 and Q4 on those step-ups just as we think about kind of the bottom end of the P&L.

了解。接著談到全年EBITDA指引。就損益表下緣的角度來看，關於第三季與第四季研發（R&D）費用的推進、以及那些階梯式上升（step-ups），你們能否提供更多說明，讓我們知道該如何看待？

Absolutely. Ron, do you want to take that?

當然可以。Ron，你要不要回答？

Sure. Thanks, Chase. Appreciate the question. So for the remainder of '26, we do expect R&D expense to increase relative to the first half of the year. That reflects the ramp up of the STARS-2 trial we initiated in June. We also expect a modest increase in SG&A expense as well, I think through OpEx.

好的。謝謝你，Chase。謝謝你的問題。就2026年剩餘期間而言，我們確實預期研發費用會相較於上半年增加。這反映了我們在6月啟動的STARS-2試驗進入加速推進（ramp up）。我們也預期SG&A費用會小幅增加，我想主要是透過營運費用（OpEx）。

And obviously, Chase, that's all going to be depending on how many sites we can get up and running and how fast we can do that. And obviously, that's a critical investment in our future. So, you know, while obviously this quarter the EBITDA was remarkably strong, I think we certainly see that continuing throughout the end year, but we clearly will see an increased expense, as Ron mentioned, but that's going to be largely dependent on how many sites we can get up and running and how fast we can do it.

而且很明顯地，Chase，這一切都取決於我們能讓多少試驗中心啟動運作，以及我們能多快做到。而這顯然是對我們未來的一項關鍵投資。所以，雖然本季EBITDA表現非常強勁，我認為我們確實看到這種態勢會延續到年底，但如Ron所提到，我們也會清楚看到費用增加，而這在很大程度上將取決於我們能讓多少試驗中心上線，以及推進速度。

And there are no further questions at this time. With that, that concludes today's conference call. Thank you all for joining us. You may now disconnect, and have a good rest of your day.

目前沒有其他問題。至此，今天的電話會議到此結束。感謝各位的參與。各位現在可以掛線，祝各位今天剩餘時間愉快。