Insmed Incorporated (INSM) 2026 Q2 法說會逐字稿

Thank you for standing by, and welcome to the Insmed second-quarter 2026 financial results conference call. (Operator Instructions)

感謝各位稍候，歡迎參加 Insmed 2026 年第二季財務業績電話會議。(接線員指示)

I'd now like to turn the call over to Bryan Dunn, Head of Investor Relations. You may begin.

現在我想把電話交給投資人關係主管 Bryan Dunn。您可以開始了。

Thank you, Rob, and good day, everyone. Welcome to Insmed's second-quarter 2026 earnings conference call.

謝謝你，Rob，大家日安。歡迎參加 Insmed 2026 年第二季財報電話會議。

Before we get started, please note that today's call will include forward-looking statements. These statements represent our judgment as of today and inherently involve risks and uncertainties that may cause actual results to differ materially from the projections discussed. Please refer to our most recent filings with the Securities and Exchange Commission for a full description of these risk factors.

在開始之前，請注意今天的電話會議將包含前瞻性陳述。這些陳述代表我們截至今日的判斷，且本質上涉及風險與不確定性，可能導致實際結果與所討論的預測存在重大差異。請參閱我們最近向美國證券交易委員會提交的文件，以取得這些風險因素的完整說明。

The information we will discuss on today's call is meant for the benefit of the investment community. It is not intended for promotional purposes, and it is not sufficient for prescribing decisions.

我們在今天電話會議中討論的資訊旨在使投資社群受益。其並非用於促銷目的，且不足以作為處方決策之依據。

Today's call will feature prepared comments from Insmed's quarterly performance and financial position by Will Lewis, Chair and Chief Executive Officer; and Sara Bonstein, Chief Financial Officer, respectively. After their remarks, we will welcome Martina Flammer, Chief Medical Officer, for the Q&A session.

今天的電話會議將由 Insmed 董事長兼執行長 Will Lewis 就本季營運表現，以及由財務長 Sara Bonstein 就財務狀況分別發表準備好的談話。在他們發言之後，我們將邀請醫務長 Martina Flammer 參與問答環節。

We'll now turn the call over to Will.

現在把電話交給 Will。

Good morning. I want to start off today's call by framing what I believe are our two key accomplishments this quarter: operational excellence and positioning for our future.

各位早安。我想以我認為本季兩項關鍵成就作為今天電話會議的開場：卓越營運與為未來布局。

Across our commercial, clinical, and research efforts, we have demonstrated exceptional operating performance. This has laid the groundwork for Insmed's potential evolution into a reliably consistent revenue and earnings growth story over the next decade and beyond. Let me briefly summarize what I mean.

在我們的商業化、臨床與研發工作上，我們展現了卓越的營運表現。這為 Insmed 在未來十年乃至更長時間，潛在演進為一個可持續且穩定的營收與獲利成長故事奠定了基礎。我簡要說明一下我的意思。

BRINSUPRI's launch continues at a truly historic pace, delivering another quarter of performance that more than doubled the results of the best specialty respiratory launches our industry has ever seen at this stage. With the potential to expand its reach with improved diagnosis of appropriate patients and a projected approval in Japan later this year, we believe the BRINSUPRI story is just getting started.

BRINSUPRI 的上市推進持續以真正具歷史性的速度前進，本季再度交出表現，其成果在此階段已超過我們產業迄今所見最佳專科呼吸道產品上市表現的兩倍以上。隨著透過更完善的適用病患診斷來擴大觸及範圍，以及預期今年稍晚在日本獲批，我們相信 BRINSUPRI 的故事才正要開始。

ARIKAYCE continues to perform well in its eighth year of launch, growing globally by high-single digits this quarter compared to the second quarter of last year. Beyond the current opportunity, there is also potential to expand the label to include all patients with MAC lung disease in the US and Japan next year. From a commercial readiness perspective, we are on track to serve a broader base of appropriate patients while providing education for physicians as we enable them to use ARIKAYCE earlier in the treatment paradigm for MAC lung disease.

ARIKAYCE 在上市第八年仍持續表現良好，本季全球營收相較去年第二季以高個位數百分比成長。除目前機會之外，明年在美國與日本亦有潛力擴大適應症標籤，涵蓋所有 MAC 肺病患者。就商業化準備度而言，我們正按計畫為更廣泛的適用病患族群提供服務，同時為醫師提供教育，協助其在 MAC 肺病的治療流程中更早使用 ARIKAYCE。

TPIP is emerging as a potentially differentiated asset across four large indications: PH-ILD, PAH, PPS, and IPS. We believe the data from our ongoing open-label extension study of TPIP in patients with PAH shared last month are further evidence of the strength of TPIP's profile, which we believe has the potential to be the prostanoid of choice.

TPIP 正逐步成為一項在四個大型適應症上具潛在差異化的資產：PH-ILD、PAH、PPS 與 IPS。我們相信，上月分享的 TPIP 在 PAH 患者之持續開放標籤延伸研究（open-label extension study）資料，進一步證明 TPIP 特性輪廓的強勁，我們認為其有潛力成為首選前列環素類藥物（prostanoid）。

In addition to the progress our top three assets are making, we are also positioning the company for continued success in the future. We are steadily progressing a broad and diversified early-stage pipeline consisting of multiple potential blockbuster treatments for a wide range of serious diseases.

除了我們前三大資產所取得的進展之外，我們也在為公司未來的持續成功進行布局。我們正穩步推進一個廣泛且多元化的早期研發管線，包含多項具潛在重磅（blockbuster）潛力的治療方案，涵蓋多種嚴重疾病。

The FDA recently cleared the IND for INS1033, the first of several next-generation DPP1 inhibitors advancing within our pipeline, to proceed into the clinic. The first planned indication for INS1033 will be in patients with rheumatoid arthritis, for which we have promising preclinical data. We anticipate following that with additional clinical programs in ulcerative colitis and COPD, for which there is also supportive preclinical data. These indications highlight the potential relevance of DPP1 inhibition beyond bronchiectasis in other large neutrophil-mediated inflammatory diseases.

FDA 近期已核准 INS1033 的 IND 申請，使其得以進入臨床；INS1033 是我們管線中數個正在推進的下一代 DPP1 抑制劑之首。INS1033 的第一個規劃適應症將是類風濕性關節炎患者，我們在此領域擁有具前景的臨床前資料。我們預期接續在潰瘍性結腸炎與 COPD 推進更多臨床計畫，這些領域同樣有支持性的臨床前資料。這些適應症凸顯 DPP1 抑制在支氣管擴張症之外，於其他大型嗜中性球介導的發炎疾病中亦具潛在相關性。

We also added new talent to our leadership team with the hiring of Samuele Butera as our Senior Vice President and General Manager of our Global Respiratory therapeutic area. Samuele brings with him a wealth of commercial experience in US and international markets, having led multiple global launches at Johnson & Johnson and Novartis throughout his career. We view his hiring as a huge win for Insmed and an equally large endorsement of Insmed's future.

我們也透過聘任 Samuele Butera 擔任全球呼吸治療領域資深副總裁暨總經理，為領導團隊增添新人才。Samuele 在其職涯中於嬌生（Johnson & Johnson）與諾華（Novartis）主導多項全球上市，具備豐富的美國與國際市場商業化經驗。我們認為他的加入對 Insmed 是一項重大勝利，也同樣是對 Insmed 未來的強力背書。

Finally, it is important to mention that we are making all these strides while maintaining our financial strength. We continue to believe we are sufficiently resourced to fund our business through cash flow positivity next year without raising additional capital.

最後，重要的是要提到，我們在取得這些進展的同時，仍維持財務實力。我們仍相信，在不額外募資的情況下，我們擁有充足資源，足以支應公司營運直至明年達成現金流轉正。

With BRINSUPRI's remarkable performance through nearly one full year of launch and the latest results from our ongoing open-label study of TPIP in PAH, our confidence in the future potential of these assets has grown. As a result, we are raising our peak sales estimates for both assets.

隨著 BRINSUPRI 在上市近滿一年期間展現的卓越表現，以及我們正在進行的 TPIP 於 PAH 開放標籤研究的最新結果，我們對這些資產未來潛力的信心已提升。因此，我們上調了兩項資產的峰值銷售額（peak sales）預估。

For BRINSUPRI, we now estimate global peak sales of greater than $7 billion, up from our previous projection of greater than $5 billion. This updated estimate reflects expected growth of the current addressable market, driven by earlier and more consistent diagnosis due to increased awareness among physicians and patients. Importantly, this peak sales projection does not include contributions from the potentially meaningful opportunity to identify additional bronchiectasis patients from the comorbid COPD and asthma populations, which would represent upside to this outlook.

就 BRINSUPRI 而言，我們目前估計其全球峰值銷售額將超過 70 億美元，高於先前預估的超過 50 億美元。此更新後的估計反映目前可觸及市場（addressable market）預期成長，成長動能來自醫師與病患認知提升所帶動的更早且更一致的診斷。重要的是，這項峰值銷售預估尚未納入一項可能相當可觀的機會：從合併症為 COPD 與氣喘的人群中辨識出更多支氣管擴張症患者；若能實現，將為此展望帶來上行空間。

For TPIP, we believe the peak sales opportunity is greater than $6 billion, up from our previous peak sales projection of greater than $2 billion, which was provided prior to seeing the strength of our Phase 2 readouts in PH-ILD and PAH and before we chose to pursue PPF and IPF. This assumes clinical and regulatory success in all four indications, and the TPIP's profile continues to distinguish itself as meaningfully differentiated versus other prostanoids with comparable efficacy to sotatercept while maintaining a favorable tolerability profile, which allows for higher dosing.

就 TPIP 而言，我們認為其峰值銷售機會將超過 60 億美元，高於先前提供的超過 20 億美元峰值銷售預估；該先前預估是在我們看到 PH-ILD 與 PAH 的第二期（Phase 2）讀出結果之強勁表現之前，以及在我們選擇推進 PPF 與 IPF 之前所提供。此預估假設四個適應症皆取得臨床與法規上的成功；且 TPIP 的特性輪廓持續展現出相較其他前列環素類藥物（prostanoids）具顯著差異化：在療效可與 sotatercept 相當的同時，仍維持良好的耐受性特徵，使其得以採用更高劑量。

Along with the reiterated peak sales estimate of greater than $1 billion for ARIKAYCE, the combined peak sales estimates for our three lead assets now exceeds USD14 billion, up 75% from the greater than $8 billion peak sales estimate we previously provided for these three products.

再加上我們重申 ARIKAYCE 峰值銷售額超過 10 億美元的預估，我們三項領先資產的合計峰值銷售預估現已超過 140 億美元，較我們先前對這三項產品所提供的超過 80 億美元峰值銷售預估上升 75%。

Let's now move to a deeper discussion of BRINSUPRI's ongoing launch. In its third full quarter of launch, BRINSUPRI produced $309.2 million in revenue. We believe BRINSUPRI is on its way to becoming the most successful launch in the history of specialty respiratory medicine and has the potential to become one of the top 20 medicine launches of all time in any category. This outstanding performance gives us confidence to increase our full-year 2026 BRINSUPRI revenue guidance to between $1.25 billion and $1.4 billion from our previous guidance of greater than $1 billion.

接下來我們將更深入討論 BRINSUPRI 持續進行的上市推進。在上市後第三個完整季度，BRINSUPRI 創造了 3.092 億美元營收。我們相信 BRINSUPRI 正邁向成為專科呼吸醫學史上最成功的上市案例，並有潛力成為任何類別史上前 20 大藥品上市之一。這項傑出表現使我們有信心將 2026 全年 BRINSUPRI 營收指引自先前的超過 10 億美元，上調至 12.5 億至 14 億美元之間。

This quarter's impressive results demonstrate the remarkable momentum of BRINSUPRI's launch and reinforce our confidence in its future. All detailed metrics we monitor, including payer access, patient compliance and continuation rates, continue to track ahead of our expectations.

本季亮眼的業績展現了 BRINSUPRI 上市所帶來的顯著動能，並進一步強化我們對其未來的信心。我們所追蹤的所有關鍵指標（包括付款方給付可近性、病患用藥依從性與持續治療率）皆持續優於我們的預期。

BRINSUPRI added approximately 7,000 new patients in the second quarter, exceeding our previous expectation of approximately 6,300 new patient starts. This result demonstrates the robust ongoing demand for the treatment. We now expect approximately 7,000 new patient starts per quarter for the remaining quarters in 2026, which is reflected in our updated revenue guidance.

BRINSUPRI 在第二季新增約 7,000 名新病患，超出我們先前預估約 6,300 名新病患開始治療的人數。此結果顯示該治療具有強勁且持續的需求。我們目前預期 2026 年剩餘各季每季約有 7,000 名新病患開始治療，並已反映在我們更新後的營收指引中。

Strong new patient demand was driven by an acceleration in new prescribers and a deepening of prescribing. As of the end of June, we had more than 6,300 cumulative prescribers, which was an increase of approximately 1,300 writers compared to the end of March.

強勁的新病患需求主要來自新開立處方醫師數加速成長，以及處方深度的提升。截至 6 月底，我們的累計處方醫師已超過 6,300 位，較 3 月底增加約 1,300 位開立者。

We are also making good progress on depth of prescribing. Approximately 30% of BRINSUPRI's writers have prescribed it for at least five of their patients, up from around 20% at the end of March. However, there is still significant opportunity here. Many doctors, including some who treat large numbers of patients with bronchiectasis, are still trialing the medicine and have considerable capacity to write for more patients if their experience is positive.

我們在處方深度方面也取得良好進展。約有 30% 的 BRINSUPRI 開立者已至少為其 5 位病患開立處方，高於 3 月底約 20% 的水準。然而，這方面仍有相當大的成長空間。許多醫師（包括部分治療大量支氣管擴張症病患的醫師）仍在試用該藥物；若使用經驗正向，他們仍有相當大的能力為更多病患開立處方。

This quarter, the European Multicenter Bronchiectasis Audit and Research Collaboration, or EMBARC, announced its intention to collaborate with us to evaluate brensocatib's 25-milligram dose in a three-year open-label study of up to 3,000 patients with bronchiectasis in six European countries. EMBARC's intention with this study is to shed light on two important questions: first, whether long-term use of brensocatib has the potential to modify the course of the disease; and second, whether earlier upstream use of brensocatib is effective in further slowing disease progression. We look forward to collaborating with EMBARC to address these important questions.

本季，歐洲多中心支氣管擴張症稽核與研究合作組織（European Multicenter Bronchiectasis Audit and Research Collaboration，簡稱 EMBARC）宣布有意與我們合作，在涵蓋六個歐洲國家、最多 3,000 名支氣管擴張症病患的三年期開放標籤研究中，評估 brensocatib 25 毫克劑量。EMBARC 進行此研究的目的在於釐清兩個重要問題：第一，長期使用 brensocatib 是否有可能改變疾病進程；第二，更早期、上游使用 brensocatib 是否能更有效地進一步減緩疾病惡化。我們期待與 EMBARC 合作，共同回答這些重要問題。

We also have ongoing plans to support additional long-term data generation through Phase 4 and real-world evidence trials in the US to further solidify our position as the leader in bronchiectasis and DPP1 inhibition and show the long-term benefits of BRINSUPRI.

我們也持續規劃透過美國的第四期（Phase 4）與真實世界證據試驗，支持更多長期資料的產出，以進一步鞏固我們在支氣管擴張症與 DPP1 抑制領域的領導地位，並展現 BRINSUPRI 的長期效益。

Beyond what we have just discussed, we see a significant opportunity to expand the diagnosed bronchiectasis population by improving diagnosis among patients with comorbid COPD or asthma. This effort to identify patients with comorbid bronchiectasis is being resourced like its own separate launch and is expected to yield increased diagnosis over the next several years.

除上述內容外，我們也看到一個重大機會：透過提升合併 COPD 或氣喘病患的診斷率，擴大已確診的支氣管擴張症族群。這項辨識合併支氣管擴張症病患的工作，投入資源的規模如同一個獨立的上市專案，預期將在未來數年帶動診斷數增加。

Some of our initial efforts around improving diagnosis, including our support behind an ATS-led initiative to analyze electronic health records across seven large academic medical systems, the Suspect BE celebrity campaign with Ty Pennington, and hosting the inaugural Bronchiectasis and COPD Stakeholder Summit at the World Bronchiectasis Conference, just to name a few. And we are just getting started, with other initiatives currently being piloted, which could advance our efforts to support earlier and more accurate diagnosis of appropriate patients.

我們在提升診斷方面的初期作為包括：支持由 ATS 主導、跨七個大型學術醫療體系分析電子病歷的倡議；與 Ty Pennington 合作的「Suspect BE」名人宣導活動；以及在世界支氣管擴張症大會（World Bronchiectasis Conference）主辦首屆「支氣管擴張症與 COPD 利害關係人高峰會」等，僅舉數例。而我們才剛起步，目前也正試行其他倡議，可能進一步推動我們支持更早且更精準診斷適當病患的努力。

We will track a variety of indicators to look for signals of progress, including monitoring claims data for increased diagnosis rates and high-resolution CT scans. Given the time it takes for this information to become available and the fact that they are trailing indicators, we will have insights from these data in approximately the middle of next year. We look forward to sharing updates as these initiatives progress. We are convinced that the best of this story is yet to come as more patients receive a proper diagnosis and gain access to appropriate treatment.

我們將追蹤多項指標以尋找進展訊號，包括監測理賠資料中診斷率與高解析度 CT 掃描的增加情況。考量這些資訊需要時間才會可取得，且屬於落後指標，我們預計約在明年年中可從這些資料獲得洞見。隨著各項倡議推進，我們也期待分享最新進展。我們深信，隨著更多病患獲得正確診斷並取得適切治療，這個故事最精彩的部分仍在後頭。

Now, let me provide an update on ARIKAYCE. In addition to continued sales growth, we are making progress toward a potential expansion from refractory MAC into all MAC lung disease. Backed by robust clinical evidence and an experienced commercial organization, we believe ARIKAYCE is well positioned to make the transition to this larger opportunity in the US and Japan.

接下來，我提供 ARIKAYCE 的最新進展。除了銷售持續成長外，我們也正朝向潛在適應症擴大邁進，從難治型 MAC 擴展至所有 MAC 肺部疾病。憑藉扎實的臨床證據與經驗豐富的商業團隊，我們相信 ARIKAYCE 已具備良好條件，可在美國與日本把握這個更大的機會並完成轉換。

We recently submitted the supplemental new drug application to the FDA for ARIKAYCE in newly diagnosed patients with MAC lung disease, and we intend to submit an application to Japanese regulators in the second half of this year in support of potential launches in 2027. This sets the stage for a particularly dynamic time for our Japan team, who could be simultaneously launching both the expanded ARIKAYCE indication and BRINSUPRI in bronchiectasis. These products have clear synergies in terms of their call points, which we expect to benefit both launches.

我們近期已向 FDA 提交 ARIKAYCE 用於新診斷 MAC 肺部疾病病患的補充新藥申請（sNDA），並計畫於今年下半年向日本主管機關提交申請，以支持 2027 年的潛在上市。這也為我們日本團隊鋪陳出一段特別動態的時期：他們可能同時推動 ARIKAYCE 擴大適應症與 BRINSUPRI（支氣管擴張症）的上市。這兩項產品在拜訪對象（call points）方面具有明確的協同效應，我們預期將有助於兩者的上市推進。

Given the impressive results we have seen from that team as they have executed on ARIKAYCE's current indication, we are excited to see the positive impact they can have on patients once presented with this expanded opportunity. We look forward to sharing additional updates on ARIKAYCE's progress as the regulatory process continues.

鑑於該團隊在執行 ARIKAYCE 現行適應症方面所展現的亮眼成果，我們也期待在這個擴大機會下，他們能為病患帶來更正面的影響。隨著法規審查流程持續推進，我們也期待分享 ARIKAYCE 進展的更多更新。

Let's turn to TPIP. Last month, we announced positive 12-month data from our ongoing open-label extension study of TPIP in patients with PAH. To contextualize how unique and impressive those results were, let's begin with a recap of the randomized Phase 2b trial that preceded it.

接著談 TPIP。上個月，我們公布了 TPIP 在 PAH 病患之持續進行的開放標籤延伸（OLE）研究中的正向 12 個月數據。為了說明這些結果有多麼獨特且令人印象深刻，我們先回顧其前一項隨機分派的第二期 b（Phase 2b）試驗。

On a placebo-adjusted basis, TPIP demonstrated a 35% reduction in PVR, a 35.5-meter improvement in six-minute walk distance, and a 60% reduction in NT-proBNP at the end of 16 weeks of treatment. Recall, each of these efficacy metrics was measured at trough or approximately 20 hours after the previous dose was administered. The magnitude of these benefits support our belief that TPIP has the potential to become the clear prostanoid of choice. This study also showed good tolerability with a low 10% dropout rate and 95% of completers choosing to continue in the OLE study.

在與安慰劑調整後的比較中，TPIP 於 16 週治療結束時顯示：PVR 降低 35%、六分鐘步行距離增加 35.5 公尺，以及 NT-proBNP 降低 60%。請記得，這些療效指標皆於谷濃度（trough）時點量測，亦即在前一次給藥後約 20 小時。這些效益的幅度支持我們的看法：TPIP 有潛力成為明確的首選前列環素類藥物（prostanoid）。本研究亦顯示良好耐受性，退出率僅 10%，且 95% 完成者選擇在 OLE 研究中繼續治療。

Let's move now to the results of the OLE study. At 12 months, patients who remained on TPIP maintained or improved across all efficacy measures. Moreover, patients who have been on placebo in the lead-in study and switched to taking TPIP in the OLE not only improved but fully caught up to the continued TPIP group. This trend is something rarely observed in other open-label extension studies in PAH patients.

現在來看 OLE 研究結果。在 12 個月時，持續使用 TPIP 的病患在所有療效指標上皆維持或進一步改善。此外，在前導研究中使用安慰劑、並於 OLE 轉換為 TPIP 的病患不僅有所改善，且完全追上持續 TPIP 組。這種趨勢在 PAH 病患的其他開放標籤延伸研究中相當罕見。

At month 12, compared to the baseline of the lead-in study, patients in the OLE experienced an approximately 55-meter improvement in six-minute walk distance and an approximately 60% reduction in NT-proBNP. Like the Phase 2b study, these endpoints were measured at trough. Additionally, about 80% of patients achieved functional Class I or II with over 25% of all patients achieving functional Class I, meaning these patients no longer have symptoms of PAH.

在第 12 個月時，相較於前導研究的基線，OLE 病患的六分鐘步行距離約提升 55 公尺，NT-proBNP 約降低 60%。與 Phase 2b 研究相同，這些終點皆於谷濃度（trough）時點量測。另外，約 80% 的病患達到功能分級 I 或 II，且超過 25% 的所有病患達到功能分級 I，代表這些病患已不再出現 PAH 症狀。

We also looked at REVEAL Lite 2.0 scores, which are a validated measure of the risk of morbidity and mortality in patients with PAH. Impressively, the average REVEAL risk status for all OLE patients improved by two categories, from intermediate risk to refined low-risk status. This improvement in score is associated with moving from a 5% to 10% risk of mortality in the next year to less than 5% risk of mortality in the next three years, along with meaningful improvements in the risk of clinical worsening. Remarkably, 65% of all patients achieved refined low-risk status by month 12. Together, these efficacy benefits far exceeded anything we have seen from other inhaled prostanoids in PAH and were comparable to sotatercept.

我們也檢視了 REVEAL Lite 2.0 分數，這是一項經驗證的指標，用於衡量 PAH 患者的發病與死亡風險。令人印象深刻的是，所有 OLE 患者的平均 REVEAL 風險狀態提升了兩個等級，從中度風險改善至精細化低風險狀態。此分數的改善與風險下降相關：由未來一年 5% 至 10% 的死亡風險，降至未來三年低於 5% 的死亡風險，同時臨床惡化風險亦有顯著改善。值得注意的是，截至第 12 個月，65% 的所有患者達到精細化低風險狀態。綜合而言，這些療效效益遠超過我們在 PAH 的其他吸入型前列環素類藥物所見，且與 sotatercept 相當。

On safety, we identified no new safety signals despite longer duration of use and higher doses in the OLE. Notably, we also saw a low 15% rate of treatment-emergent cough, which was predominantly mild, and only one discontinuation due to cough over the first 12 months of the study. In addition, we saw high continuation rate, with 91% of patients remaining on treatment at the 12-month point. Overall, these results add to our confidence in TPIP's potential to be the next major advancement in the treatment of PAH.

在安全性方面，儘管 OLE 的使用時間更長且劑量更高，我們仍未發現新的安全性訊號。尤其值得一提的是，我們也觀察到治療期間新發咳嗽的發生率僅 15%，且多為輕度；在研究前 12 個月內，僅有 1 例因咳嗽而停藥。此外，我們看到很高的持續治療率，在 12 個月時仍有 91% 的患者持續接受治療。整體而言，這些結果進一步提升我們對 TPIP 有望成為 PAH 治療下一項重大進展的信心。

Our comprehensive Phase 3 development program is progressing well, with both our PH-ILD and PAH studies actively enrolling patients. In the past, we have seen a boost in enrollment after sharing positive data updates from the program. We hope that the strength of the OLE data will once again bolster interest in our trials.

我們全面性的第 3 期開發計畫進展順利，PH-ILD 與 PAH 兩項研究皆在積極招募患者。過去我們曾在分享該計畫的正向數據更新後，看到入組速度提升。我們希望 OLE 數據的強勁表現能再次提升外界對我們試驗的興趣。

We are also pleased to report the first Data Monitoring Committee meeting for the PALM-ILD study recently occurred, resulting in a positive recommendation for the study to continue unmodified. Additional Phase 3 studies in PPF and IPF, two additional large indications, remain on track to initiate in the second half of 2026 and the first half of 2027, respectively.

我們也很高興報告，PALM-ILD 研究近期已召開首次資料監測委員會會議，並獲得正向建議：研究可在不作修改的情況下繼續進行。另外兩項大型適應症——PPF 與 IPF——的其他第 3 期研究仍按計畫推進，預計分別於 2026 年下半年與 2027 年上半年啟動。

In the Phase 3 studies, patients begin with an initial titration phase to a target dose of 640 micrograms once daily. Upon completing titration, investigators may further escalate the dose to a maximum of 1,280 micrograms once daily when clinically appropriate. The decision to escalate is based on individualized clinical judgment, taking into account the patient's treatment tolerability and clinical status, including evidence of disease progression or the potential for additional therapeutic benefit.

在第 3 期研究中，患者先進入初始滴定期，滴定至每日一次 640 微克的目標劑量。完成滴定後，研究者可在臨床適當時，將劑量進一步上調至每日一次最高 1,280 微克。是否上調的決策係基於個別化的臨床判斷，並考量患者對治療的耐受性與臨床狀態，包括疾病進展的證據或可能獲得額外治療效益的機會。

We believe TPIP's broad dosing range could provide physicians with the flexibility to optimize the balance between efficacy and tolerability, while also allowing treatment strength to be adjusted as the patient's clinical needs change. The flexibility to quickly and safely dose to much higher levels than other inhaled treprostinil products could represent a meaningful differentiator within the class and resembles the individualized dosing approach physicians already use with parenteral therapy since patients respond differently across treprostinil dose levels and their dose requirements may increase over time. The ability to continue to dose higher could also expand the duration of time patients spend on inhaled therapy, delaying the need for patients to switch to parenteral options.

我們相信 TPIP 的廣泛劑量範圍可讓醫師更具彈性地在療效與耐受性之間取得最佳平衡，同時也能隨患者臨床需求變化調整治療強度。相較其他吸入型 treprostinil 產品，能夠快速且安全地調整至更高劑量，可能成為此藥物類別中的重要差異化特點；這也類似醫師在注射（腸外）治療中已採用的個別化劑量策略，因患者對不同 treprostinil 劑量的反應不一，且其劑量需求可能隨時間增加。持續提高劑量的能力亦可能延長患者使用吸入治療的時間，延後患者改用注射（腸外）選項的需求。

As I look across our portfolio at BRINSUPRI's historic launch trajectory, ARIKAYCE's steady contributions, and TPIP's potential to be the prostanoid of choice in our earlier-stage programs, which are steadily producing encouraging data, I am energized by what the future can hold for Insmed. I believe we are only just scratching the surface of the positive impact this company can have on patients in need.

綜觀我們的產品組合——BRINSUPRI 歷史性的上市成長軌跡、ARIKAYCE 穩健的貢獻，以及 TPIP 在我們較早期計畫中有望成為首選前列環素類藥物，而這些計畫也持續產出令人鼓舞的數據——我對 Insmed 未來的可能性充滿期待。我相信，我們對有需求患者所能帶來的正向影響，才剛剛開始展現。

With that, I'll turn the call over to Sara, who will walk you through the financial details of the quarter.

接下來我把電話會議交給 Sara，由她帶各位了解本季的財務細節。

Thank you, Will, and good morning, everyone. I'm pleased to share our second-quarter 2026 financial results and updated guidance and to provide some commentary to help with your modeling.

謝謝你，Will，各位早安。我很高興分享我們 2026 年第二季的財務結果與更新後的財測指引，並提供一些說明以協助各位進行模型推估。

BRINSUPRI produced $309.2 million in revenue in the second quarter, up 49% sequentially from an already strong first quarter, in which we saw a sequential growth of 44%. This growth was primarily driven by strength in new and existing patient demands. This quarter also benefited from better-than-expected gross-to-net dynamics which brought GTN towards the lower end of our previous guidance range of mid-20s to low-30s.

BRINSUPRI 在第二季創造 3.092 億美元營收，較已相當強勁的第一季再度季增 49%；而第一季我們已看到 44% 的季增。此成長主要由新患者與既有患者需求的強勁表現所帶動。本季亦受惠於優於預期的毛額到淨額（gross-to-net）動態，使 GTN 靠近我們先前指引區間（約 20% 中段至 30% 低段）的較低端。

ARIKAYCE produced $116.3 million in revenue this quarter, representing 8% growth compared to the second quarter of 2025. GTN for ARIKAYCE this quarter fell within the guidance range for the year of low to mid-20s.

ARIKAYCE 本季營收為 1.163 億美元，較 2025 年第二季成長 8%。ARIKAYCE 本季的 GTN 落在全年指引區間的 20% 低段至中段。

On this slide, you can see our current guidance ranges for BRINSUPRI and ARIKAYCE revenue for full year 2026, as well as our gross-to-net expectations for each product. As Will mentioned, based on the strong results we have produced in the first half of the year, we are raising our full-year 2026 BRINSUPRI revenue from greater than $1 billion to a range of $1.25 billion to $1.4 billion. While we continue to expect a regulatory decision in Japan for BRINSUPRI in the second half of the year, we do not expect a meaningful revenue contribution from Japan in 2026.

在這張投影片上，各位可以看到我們對 2026 全年 BRINSUPRI 與 ARIKAYCE 營收的最新指引區間，以及各產品的毛額到淨額（gross-to-net）預期。如 Will 所提，基於我們在上半年所交出的強勁成果，我們將 2026 全年 BRINSUPRI 營收指引由「高於 10 億美元」上調至 12.5 億至 14 億美元區間。雖然我們仍預期 BRINSUPRI 在日本將於下半年取得法規決定，但我們不預期日本在 2026 年會帶來具意義的營收貢獻。

ARIKAYCE continues to perform as the steady reliable contributor it has been for nearly eight years. We are reiterating our full-year revenue guidance for ARIKAYCE of $450 million to $470 million. We continue to see potential for expanded label in the US and Japan next year as an upside catalyst for this program.

ARIKAYCE 持續展現其近八年來一貫穩健可靠的貢獻者角色。我們重申 ARIKAYCE 全年營收指引為 4.5 億至 4.7 億美元。我們仍看好明年在美國與日本擴大適應症標籤的潛力，作為此計畫的上行催化劑。

On gross-to-net, we are updating our 2026 gross-to-net guidance for BRINSUPRI to mid- to high-20s, which represents an improvement from our previous guidance range of mid-20s to low-30s. Given we are at the midpoint of 2026, we have confidence in this improvement as we do not foresee any large changes in our contracting strategy for the remainder of the year. Therefore, we expect gross-to-net for BRINSUPRI to remain within this updated guidance range for each of the remaining quarters in 2026. In addition, we are reiterating our GTN guidance for ARIKAYCE of low- to mid-20s.

在毛額到淨額方面，我們將 2026 年 BRINSUPRI 的 GTN 指引更新為 20% 中段至高段，較先前 20% 中段至 30% 低段的指引區間有所改善。鑑於目前已進入 2026 年中，我們對此改善具信心，因為我們預期今年剩餘期間的合約策略不會出現重大變動。因此，我們預期 BRINSUPRI 的毛額到淨額在 2026 年其餘各季都將維持在此更新後的指引區間內。此外，我們重申 ARIKAYCE 的 GTN 指引為 20% 低段至中段。

Moving now to the other relevant financial metrics for the second quarter, which are displayed on this slide. Cost of product revenues was $67.2 million, or 16% of revenues, which is lower on a percentage basis than the 26% we saw in the second quarter of the prior year, reflecting the positive contribution of BRINSUPRI to the company's gross margin profile. As expected, combined research and development and SG&A expenses increased this quarter, up 38% compared to the prior-year period due to the necessary investments made to support the US launch of BRINSUPRI and to continue to fund our pipeline.

接著看第二季其他相關財務指標，已呈現在這張投影片上。產品營收成本為 6,720 萬美元，占營收 16%；以比例而言低於前一年度第二季的 26%，反映 BRINSUPRI 對公司毛利結構帶來的正向貢獻。如預期，本季研發費用與銷售、一般及行政（SG&A）費用合計增加，較去年同期成長 38%，主要因支持 BRINSUPRI 在美國上市所需的投資，以及持續投入資金以推進我們的產品線。

Let me now spend a moment on our cash position and burn rate. As of the end of the second quarter of 2026, we had approximately $1.2 billion in cash, cash equivalents, and marketable securities, which represents a meaningfully lower burn rate than we have seen in recent quarters. This is attributed to higher revenue generation as well as appropriate financial discipline.

現在我想花一點時間談談我們的現金部位與現金消耗率（burn rate）。截至2026年第二季末，我們持有約12億美元的現金、約當現金及有價證券，這代表相較於近幾季，我們的現金消耗率顯著降低。這主要歸因於營收增加，以及適當的財務紀律。

While we continue to expect to increase revenue generation in the second half of the year, we simultaneously expect to invest more in important initiatives to drive future growth, including the Phase 3 programs for TPIP across four indications, the launch and branded direct-to-consumer advertising for BRINSUPRI, and incremental investments in Japan to build out an appropriate sales force and other commercial infrastructure to support future launches of both BRINSUPRI and first-line ARIKAYCE. We also anticipate incurring payments totaling $50 million to AstraZeneca related to regulatory and sales-based milestones for BRINSUPRI in the second half of 2026.

雖然我們仍預期在下半年提升營收創造能力，但同時也預期將加大對推動未來成長之重要計畫的投資，包括TPIP在四個適應症上的第三期（Phase 3）計畫、BRINSUPRI的上市與品牌化的直接面向消費者（DTC）廣告，以及在日本的額外投資，以建立適當的銷售團隊與其他商業基礎設施，來支援BRINSUPRI與第一線ARIKAYCE未來的上市。我們也預期在2026年下半年，將因BRINSUPRI的法規與銷售里程碑而向阿斯特捷利康（AstraZeneca）支付合計5,000萬美元。

We believe we are sufficiently funded to support these initiatives and the current operations of the company until we reach cash flow positivity, which we continue to expect to occur in 2027. As a reminder, we do not currently intend to raise additional capital before reaching that milestone.

我們相信，我們的資金足以支援這些計畫以及公司目前的營運，直到我們達到現金流轉正（cash flow positivity）；我們仍預期該情況將於2027年發生。提醒一下，在達到該里程碑之前，我們目前不打算再募集額外資本。

Finally, I want to share our perspective on the long-term financial profile of this company because I believe it is not fully appreciated. Based on the value drivers Will described, we expect our revenue trajectory to continue to grow well into the 2030s. But what makes this growth profile even more compelling is that it is driven by a largely synergistic portfolio of respiratory assets with similar infrastructure and overlapping call points. These synergies set us up to leverage our strong expected revenue CAGR into attractive and persistent EPS growth.

最後，我想分享我們對公司長期財務輪廓的看法，因為我認為市場尚未充分理解。基於Will所描述的價值驅動因素，我們預期營收軌跡將持續成長，並一路延伸至2030年代。但讓這個成長輪廓更具吸引力的是，它主要由一個高度協同的呼吸道資產組合所驅動，這些資產共享相似的基礎設施，且拜訪對象（call points）高度重疊。這些協同效應使我們能將預期強勁的營收年複合成長率（CAGR）轉化為具吸引力且可持續的每股盈餘（EPS）成長。

Insmed is not simply a revenue growth story. We are building towards a financial profile that we believe will be highly compelling from both a top- and bottom-line perspective and one that we expect to translate into a period of lasting value creation.

Insmed不僅僅是一個營收成長的故事。我們正在打造一個財務輪廓；我們相信，無論從營收端或獲利端來看都將極具吸引力，並且我們預期這將轉化為一段持續創造價值的期間。

With that, we would now like to open the call to questions. Operator, may we take the first question, please.

接下來，我們想開放電話會議進入提問。接線員，麻煩請讓我們進行第一個問題。

(Operator Instructions) Jessica Fye, JPMorgan.

(接線員指示) Jessica Fye，摩根大通（JPMorgan）。

Hey, guys. Good morning. Thanks for taking my questions, and congrats on the strong quarter. For the increase to BRINSUPRI's peak potential, can you expand a bit on what underpins that? Anything you can add around the earlier and more consistent diagnosis that you're seeing?

嗨，各位。早安。謝謝讓我提問，也恭喜本季表現強勁。關於上調BRINSUPRI的峰值潛力，你們能否多談一些其背後的支撐因素？另外，對於你們看到更早且更一致的診斷趨勢，還能補充些什麼嗎？

So what I would say about the increase in peak sales and our guidance for the year, they're obviously informed by what's now basically our first year under our belt. We launched last year in August. And the data, I would say, I would describe as remarkably consistent, not only in terms of performance because first quarter was strong, this quarter is strong, maybe even stronger.

我想說的是，峰值銷售的上調以及我們對今年的指引，顯然是基於我們現在基本上已經累積了第一年的經驗。我們在去年8月上市。而這些數據，我會形容為非常一致，不僅在表現上如此，因為第一季很強，本季也很強，甚至可能更強。

And I would say that that matches our internal modeling or it exceeds it. And that is what is really the core of our confidence that this is going to continue for some time. Every year at this time, we do not only our Board meeting, but we do an off-site, a strategic review of everything at the company. We take a whole day to do that with our Board. And the completion of that has resulted in our obviously assessing everything going on in the company and taking a longer-term view on all of those trends and directions.

而且我會說，這與我們的內部模型相符，甚至超出。這正是我們信心的核心，讓我們相信這樣的趨勢會持續一段時間。每年這個時候，我們不僅會開董事會，還會進行一次場外的策略檢視，全面回顧公司的一切。我們會和董事會一起花上一整天來做這件事。完成這些後，我們當然會評估公司正在發生的所有事情，並以更長期的角度看待所有這些趨勢與方向。

And as a result of that, we have the latest and greatest thinking surrounding peak sales estimates and year estimates. And that's why we've chosen this time to update everybody.

因此，我們得出了關於峰值銷售預估與年度預估的最新、最完善的看法。這也是我們選擇在此時向大家更新的原因。

Thank you.

謝謝。

Joe Schwartz, Leerink Partners.

Joe Schwartz，Leerink Partners。

Thanks. Congratulations on the strong performance and outlook. You now have a larger cohort of patients with sufficient time on therapy to begin evaluating refill behavior. What can you share about persistence, refill timing, discontinuations, and adherence? And how are those things tracking relative to the assumptions you shared with us previously?

謝謝。恭喜你們表現強勁以及前景展望。你們現在有更大一批患者，治療時間已足夠長，可以開始評估續配（refill）行為。你們能分享一下持續用藥（persistence）、續配時間點、停藥（discontinuations）以及依從性（adherence）的情況嗎？這些指標相較於你們先前與我們分享的假設，追蹤結果如何？

Yeah. And what I would say is that this is possibly one of the great strengths of this launch. Across all the metrics you just mentioned, we are at or ahead of our internal benchmarks. Not only that, but those elements are both strong and, I would say, stable. So again, giving us confidence as we look forward that this is going to continue in this favorable way.

好的。我想說，這可能是這次上市最強的優勢之一。就你剛提到的所有指標而言，我們都達到或超過內部基準。不僅如此，這些要素不但強勁，而且我會說相當穩定。因此，再次讓我們對未來充滿信心，相信這種有利的態勢會持續下去。

One thing I will just say about some of these forward and new numbers, things like the peak sales number, that assumes a very strong DPP1 competitor gets introduced into the market. And it also assumes the IRA Health and Human Services price negotiation takes effect in 2035. So this is a real-world assessment of where we're going to go.

另外我想補充一點，關於一些前瞻性與新的數字，例如峰值銷售數字，那是基於一個假設：市場將引入一個非常強的DPP1競爭對手。同時也假設《降低通膨法案》（IRA）下衛生與公共服務部（HHS）的藥價協商將於2035年生效。因此，這是一個對我們將走向何處的現實世界評估。

Very helpful. Thank you.

非常有幫助。謝謝。

Vamil Divan, Guggenheim Securities.

Vamil Divan，Guggenheim Securities。

Great. Thanks for taking my questions. Congrats on the impressive results here. So I just have a question on the new patient starts. You mentioned the 7,000 new patient starts this quarter and then sort of the guidance. So I expect around that number remaining quarters of the year. So that's obviously quite a bit higher than the 6,300 that you were expecting just a little bit ago.

很好。謝謝讓我提問。恭喜這裡令人印象深刻的成果。我有一個關於新患者起始用藥（new patient starts）數量的問題。你們提到本季有7,000名新患者起始用藥，並且也提到了指引。所以我預期今年剩餘各季大概會維持在這個數字附近。這顯然比你們不久前預期的6,300高出不少。

So I'm curious the confidence you have on that number staying flat and not continuing to rise since we're still relatively early in the launch. If you can just comment, was all of the 7,000 these so-called organic patients? Or was there still some of that ready and waiting group that you talked about previously? Thanks.

因此我想了解，你們對這個數字能維持持平、而不是繼續上升的信心來源是什麼，畢竟我們仍處於上市相對早期。另外請你們評論一下，這7,000人是否全部都是所謂的自然（organic）患者？還是仍包含你們先前提到的那批「已準備好、在等待」的族群？謝謝。

Yeah. No, thanks for the question. That is all organic. The 7,000 number is just -- it's an impressive expansion from the 6,300 we thought we were going to get, and it speaks to the strength of the commercial team and the performance they've delivered. I fully expect that that 7,000 will remain.

是的。不，謝謝你的問題。那全部都是自然（organic）的。7,000這個數字——相較於我們原先以為會達到的6,300，是一個令人印象深刻的擴張，也反映了商業團隊的實力以及他們所交出的表現。我完全預期7,000會維持下去。

Is there room for it to increase? Of course. We'll see how that goes, but our current guidance for the year assumes it will be 7,000 every quarter for the remainder of the year.

它有沒有空間再增加？當然有。我們會觀察後續發展，但我們目前對今年的指引是假設今年剩餘各季每季都是7,000。

Okay. Thank you.

好的。謝謝。

Jason Zemansky, Bank of America.

Jason Zemansky，美國銀行。

Great. Good morning. Congrats on the stellar quarter, and thanks so much for taking our question. I wanted to dig into prescribing depth for brenso a little bit more. I think you said about 30% of prescribers are now writing for at least five patients.

太好了。早安。恭喜本季表現亮眼，也非常感謝你們回答我們的問題。我想再更深入了解一下 brenso 的處方深度。我記得你們提到，目前大約有 30% 的開方醫師已經至少為五位病人開立處方。

But what typically gives physicians enough confidence to reach that level? And once they do, do you see prescribing accelerate as they gain experience with the drug? I guess, is there a point at which BRINSUPRI shifts from being evaluated patient by patient to becoming the default treatment within a practice? Thanks.

但通常是什麼讓醫師有足夠信心達到這個水準？而一旦達到之後，你們是否看到他們隨著用藥經驗累積而加速開方？換句話說，是否存在某個時間點，BRINSUPRI 會從逐一病人評估，轉變為診所內的預設治療？謝謝。

Thanks for the question. I think your final line conclusion is exactly what we anticipate will ultimately happen, that there will be a point at which this switches from the trialist sort of going patient by patient to this becoming the default for the treatment of bronchiectasis. And I think that is something we see taking place in the future.

謝謝你的提問。我想你最後那句結論正是我們最終預期會發生的情況：會有一個時間點，從試用者逐一病人嘗試，轉變為成為支氣管擴張症治療的預設選項。我認為這會在未來逐步發生。

Right now, we're pleased to see the improvement. Remember that, last quarter, we had 20% of physicians who had written more than five. That's now moved to 30%. And the impressive results this quarter reflect that. However, what I'm particularly excited about is that there's so much more room to run here. With only 30% having written more than five and remembering that our Tier 1 physicians have over 100 patients each, there is a lot of room for even our Tier 1 physicians who are writing more than five to really pick up the pace.

就目前而言，我們很高興看到改善。請記得，上季有 20% 的醫師開立超過五位病人的處方。現在已提升到 30%。而本季亮眼的結果也反映了這點。不過，我特別興奮的是，這裡還有很大的成長空間。目前只有 30% 開立超過五位病人處方，同時也要記得我們的第一級（Tier 1）醫師每位都有超過 100 名病人，因此即便是那些已開立超過五位病人的 Tier 1 醫師，也仍有很大空間可以真正加快節奏。

And that's something we're focused on very much in terms of our commercial calling effort. Some of the very metrics that we're putting out today actually go into the hands of our therapeutic specialists to inform physicians, hey, 26,350 new patient starts since this drug was launched. There are 28,000 physicians of whom we have managed to convince 6,300 to write a prescription.

這也是我們在商業拜訪（commercial calling）工作上非常聚焦的重點。我們今天公布的一些指標，實際上也會交到我們的治療領域專員手上，用來向醫師傳達：嘿，自這款藥上市以來，已有 26,350 位新病人開始用藥。共有 28,000 位醫師，其中我們已成功說服 6,300 位開立處方。

So there is a lot of room to run here. And that's why we see this guidance for the year and the ultimate peak sales number increasing the way we have just reflected.

所以這裡還有很大的成長空間。這也是為什麼我們對今年的指引，以及最終峰值銷售額的預期，會如同剛才所反映的那樣上調。

Great. Thanks for the color.

很好。謝謝補充說明。

Olivia Saunders, Cantor Fitzgerald.

Olivia Saunders，Cantor Fitzgerald。

Hi. Good morning. Thank you for the question. You guys noted that the gross-to-net obviously came in at the lower end of the range this quarter. And I know you've tightened full-year guidance to the mid- to high-20s.

嗨。早安。謝謝讓我提問。你們提到本季的毛到淨（gross-to-net）顯然落在區間的低端。我也知道你們把全年指引收斂到 20% 中段到高段。

So as we think about 2027 and beyond, is that steady-state GTN profile? Is that how we should assume it will be going forward in that kind of mid- to high-20s? Just trying to think through where that number could eventually settle and whether we're already at that point in the launch. Thank you, guys, and congrats on a great quarter.

所以當我們思考 2027 年及之後，這會是穩態（steady-state）的 GTN 結構嗎？也就是說，我們是否應假設未來會維持在 20% 中段到高段這樣的水準？我只是想釐清這個數字最終可能落在哪裡，以及我們是否已經在這次上市過程中到達那個點。謝謝各位，也恭喜本季表現很棒。

Thanks for that. Sara, do you want to take that question?

謝謝。Sara，你要回答這題嗎？

Sure. Thanks, Olivia, for the question. Now that we're obviously at the midpoint of the year, we have a clear line of sight. We don't expect any changes for the remainder of this year and expect that the coming quarters this year will be within that range. Payer access has been really favorable, about 90% approval rate, approval in less than a week for a majority of patients. So access sort of top-notch piece of this launch.

好的。謝謝你的問題，Olivia。現在我們顯然已經來到年度中點，因此能見度很清楚。我們預期今年剩餘期間不會有任何變化，也預期今年接下來幾季會落在該區間內。付款方准入（payer access）非常有利，核准率約 90%，且多數病人在一週內就能獲得核准。所以在這次上市中，准入可說是表現非常出色的一環。

As you think about '27 and beyond, we're obviously not providing forward-looking guidance, but you should -- naturally, what you expect to see with gross-to-net is gross-to-net does naturally go up a little bit each year. Again, not going to provide forward-looking guidance, but for this year, we have confidence in the mid- to high-20s.

至於你提到 2027 年及之後，我們當然不提供前瞻性指引，但你應該——一般而言，你會看到毛到淨（gross-to-net）每年自然會略為上升一些。再次強調，我們不會提供前瞻性指引，但就今年而言，我們對 20% 中段到高段的水準有信心。

Ritu Baral, TD Cowen.

Ritu Baral，TD Cowen。

Good morning, guys. And I want to add my congrats on these metrics, too. One of the things that we have been watching on Symphony TRxs is seemingly an improved compliance rate or at least fill rate.

各位早安。我也想對這些指標表現表示祝賀。我們一直在觀察 Symphony 的 TRx 數據，看起來依從性（compliance）或至少領藥/取藥率（fill rate）似乎有所改善。

Can you go over sort of what initiatives you may be conducting to promote compliance? Is it patient focused? Is it insurance focused? Is it doctor focused? And if you could just comment on continuing Symphony TRxs and how accurate they'll be through the end of the year. Thanks.

你們能否說明一下，為了提升依從性，你們可能正在推動哪些措施？是以病人為主嗎？是以保險為主嗎？還是以醫師為主？另外也請評論一下 Symphony TRx 數據的延續性，以及到年底前它們會有多準確。謝謝。

Yeah. So the first and most important point to understand as it relates to persistence, which, again, is both strong and stable, is that the medicine itself, I think, is the greatest form of advertising. Patients, many of them feel better taking this medicine, and so they want to stay on the medicine.

好的。首先，關於持續用藥（persistence）——再次強調，它既強勁又穩定——最重要的一點是，藥物本身我認為就是最好的廣告。許多病人服用這個藥後感覺變好，因此他們想要持續用藥。

The physicians are hearing that. That becomes something that they reflect to future potential patients and that they themselves trial and experiment with. That then dovetails and extends out into our education of the insurance and physician and patient efforts that we undertake in compliant ways.

醫師也會聽到這些回饋。這會成為他們向未來潛在病人轉述的內容，也會促使他們自己去試用與探索。接著，這也與我們在合規前提下所進行的保險端、醫師端與病人端教育工作相互呼應並延伸。

This medicine is -- simply put, it's a good medicine. It has a low dropout rate. It is something that makes many patients feel better. And the avoidance of what we refer to as the heart attack for the lung and exacerbation or a flare is a very meaningful thing for these patients.

簡單來說，這是一款好藥。停藥率低。它能讓許多病人感覺更好。而避免我們所稱的「肺部心肌梗塞」——也就是急性惡化或發作（flare）——對這些病人而言非常重要。

Interestingly, those where there are patients who stop taking the medicine, they are inevitably going to have one of those flares or experiences. And that's going to drive them right back into the physician's office with a question of what can I do about it, and the answer being you can take BRINSUPRI. So I think we really have a very sort of unique ecosystem around this medicine in terms of its profile and how it's perceived and taken up.

有趣的是，對於那些停止用藥的病人，他們幾乎不可避免會出現其中一次發作或不適經驗。這會促使他們回到醫師診間，詢問我能怎麼做，而答案就是你可以服用 BRINSUPRI。因此我認為，圍繞這款藥的特性、外界觀感與採用方式，我們確實擁有一個相當獨特的生態系。

And just to address your other question on Symphony TRxs, yes, that continues to track very tightly with what we see internally through its most recent report.

另外回應你關於 Symphony TRx 的問題：是的，根據其最新報告，它仍然與我們內部看到的數據高度一致。

Thank you.

謝謝。

Gavin Clark-Gartner, Evercore ISI.

Gavin Clark-Gartner，Evercore ISI。

Hey, guys. Thanks for taking the question. Could you just help us understand the 2026 BRINSUPRI guidance a little more? I mean, we're sitting here in August, and it's still a fairly wide range for the course of this year. So you noted 7,000 patient adds moving forward. Beyond that, what takes you to the high end or the low end of this BRINSUPRI guidance? Thank you.

嗨，各位。謝謝讓我提問。能否請你們再多幫我們理解一下 2026 年 BRINSUPRI 的指引？我的意思是，現在已經 8 月了，但今年的區間仍然相當寬。你們提到未來每季新增 7,000 名病人。除此之外，哪些因素會讓你們落在 BRINSUPRI 指引的高端或低端？謝謝。

Well, I think it's important to remember that, at the beginning of the year, we had gone from what was a referenceable indication of what success looked like that was $500 million to $700 million in revenue in the first full year. That was based on other specialty respiratory launches. We then increased guidance to over $1 billion at the beginning of the year. And here, we sit with only three full quarters under our belt, and we have just raised that guidance by 25% to 40%.

嗯，我認為重要的是要記得，在年初時，我們從一個可作為參考、用來衡量成功樣貌的指引出發，也就是在第一個完整年度達到5億至7億美元的營收。那是基於其他專科呼吸道產品的上市經驗。接著我們在年初把指引上調到超過10億美元。而現在，我們才剛走過三個完整季度，就又把該指引再上調了25%到40%。

So that is a way to capture the journey that we have gone on. We're now more than double what we initially thought we might do in the first full year. We will see what the next quarter holds. But I think the guidance is trying to be responsible in saying there's a lot of opportunity here. We can't assume it's going to fall into our lap. I have tremendous confidence in the commercial team. And I'm convinced that whatever can be accomplished with this medicine, they're going to bring it over the finish line.

所以，這就是用來概括我們一路走來的歷程。我們現在的預期已經是最初認為第一個完整年度可能達成水準的兩倍以上。我們會看看下一季會帶來什麼。但我認為，這份指引是在負責任地表達：這裡有很大的機會。我們不能假設機會會自動送上門。我對商業團隊非常有信心。而且我相信，無論這款藥物能做到什麼，他們都會把它推到終點線。

But I think right now, we feel comfortable raising to this new level of $1.25 billion to $1.4 billion. And as we move through the rest of the year, we'll certainly provide guidance on where we might end up within that and how that might change. That's as much as we can really say at this point.

但我認為就目前而言，我們對把指引上調到新的水準——12.5億至14億美元——感到安心。隨著我們走完今年剩餘時間，我們當然會提供指引，說明我們可能落在該區間的哪個位置，以及這可能如何變動。就目前而言，我們能說的大概也就這些。

Great. Thanks.

很好。謝謝。

Leonid Timashev, RBC Capital Markets.

Leonid Timashev，RBC Capital Markets。

Hey, guys. Thanks for taking my question. Just wanted to ask on the TPIP guide actually and the $6 billion. I guess, how are you thinking about the components there? And then specifically on IPF, are you assuming that you succeed in breaking orphan designation there? Is it sort of probability adjusted weighted? I'm just trying to understand sort of how you get to that $6 billion across all the components. Thanks.

嗨，各位。謝謝讓我提問。我想問的是關於TPIP的指引，實際上還有那個60億美元。我想知道你們是如何看待其中的組成部分？另外特別針對IPF，你們是否假設能成功解除那裡的孤兒藥資格？這是否是做了機率加權調整？我只是想理解，你們如何把所有組成部分加總到60億美元。謝謝。

Yeah. So I think it's very important for people to understand, we assume that we will be approved in all four of the indications: PAH, PH-ILD, IPF, and PPF. We assume we do overcome the orphan status for IPF. And we assume that we have a profile that is not only clearly superior to other prostanoids but is comparable to sotatercept.

是的。所以我認為讓大家理解非常重要：我們假設我們會在四個適應症全部獲批：PAH、PH-ILD、IPF，以及PPF。我們假設我們確實能克服IPF的孤兒藥身分。我們也假設我們擁有的特性不僅明顯優於其他前列環素類藥物（prostanoids），而且可與sotatercept相當。

One of the interesting comments made when we were reviewing our Phase 2 open-label extension data was the description by the key opinion leader we had invited to join the call that, from his point of view, not only does the profile we produced represent the holy grail, to use his words, of data, but it represents something that causes him to rethink the positioning of this prostanoid relative to something like sotatercept. So I'm very excited about where these results, should they continue.

在我們回顧第二期開放標籤延伸試驗數據時，有一個很有意思的評論：我們邀請加入電話會議的一位關鍵意見領袖（KOL）形容，從他的觀點來看，我們所呈現的特性不僅是他用語中的「聖杯」級數據，而且也讓他重新思考，這個前列環素類藥物相對於像sotatercept這類療法的定位。所以，如果這些結果能持續下去，我對其走向非常興奮。

Where they will take us in each of those four indications, we're not breaking down what part of the $6 billion comes from where. I will just observe that I've seen some published estimates that sotatercept alone in PAH will achieve somewhere in the neighborhood of $7 billion in revenue from that perspective. And assuming comparability and hearing the instinct of the KOL that Insmed may be with TPIP in a place to compete there, I think the $6 billion feels pretty comfortable.

至於在那四個適應症中，這些結果會把我們帶到哪裡，我們不會拆解60億美元中各部分分別來自哪裡。我只想指出，我看過一些已發表的估算，認為僅sotatercept在PAH就能達到約70億美元左右的營收。在假設可比性、並聽到該KOL的直覺認為Insmed的TPIP可能具備在那裡競爭的條件下，我覺得60億美元這個數字相當令人安心。

Faisal Khurshid, Jefferies.

Faisal Khurshid，Jefferies。

Hey, guys. Thanks for taking the question. I wanted to ask you, you made some comments in the past about the BRINSUPRI ex-US launch sort of pending clarity on MFN. Can we just get an update on your latest views on that and also how the Japan launch plays into that potentially? Thank you.

嗨，各位。謝謝讓我提問。我想問一下，你們之前曾提到BRINSUPRI在美國以外的上市，某種程度上取決於MFN的明確性。能否更新一下你們目前對此的最新看法？另外，日本的上市在其中可能扮演什麼角色？謝謝。

Sure. So MFN is but one component part of the assessment of how to bring the medicine to Europe. It's relevant, but it is not controlling. I would say the bigger issue going on in Europe right now is the lack of apparent willingness or interest on the part of most of the European countries because of budget constraints to really lean in and pay for the innovation that all these years and billions of dollars require. That lack of willingness makes it less attractive to go there with a traditional commercial approach to Europe.

當然。所以，MFN只是我們評估如何把藥物帶到歐洲的其中一個組成部分。它有相關性，但並非決定性因素。我會說，歐洲目前更大的問題是：由於預算限制，多數歐洲國家似乎缺乏意願或興趣，去真正投入並支付這些年來與數十億美元所需的創新成本。這種缺乏意願，使得以傳統商業模式進入歐洲的吸引力降低。

But nonetheless, we have tested this drug in the European market. We want to find ways to make sure that the drug can get to patients who are appropriate, and we have some ideas about how we're going to accomplish that. But there's no doubt that the European opportunity is less today than it was in the distant past. And that's true not just for us, but for everybody.

但即便如此，我們已在歐洲市場測試過這款藥物。我們希望找到方法，確保藥物能送達適合的病患手中，而我們也有一些想法，將如何達成。但毫無疑問，歐洲的機會如今比很久以前要小。而這不只是對我們如此，對所有人都是如此。

In contrast, Japan, where we have just come from the launch meeting for BRINSUPRI in terms of getting ready, the senior team was over there visiting with our team, getting the review of where they are and how they're positioned for both the BRINSUPRI launch when it gets approved, and the ARIKAYCE label expansion. And I can reflect my own enthusiasm for the capabilities of that team and what they're going to be able to produce.

相較之下，日本——我們剛從那邊的BRINSUPRI上市籌備會議回來——高階團隊到當地拜訪我們的團隊，檢視他們目前的進度，以及他們如何為BRINSUPRI在獲批後的上市、以及ARIKAYCE適應症擴增的標籤更新做好定位。我也可以表達我個人對該團隊能力的熱忱，以及他們將能交出的成果。

Overall, international sales and revenue for this kind of a product tend to be in the sort of 10% to 15% range. I would expect the majority of that will come from Japan, and I couldn't be more excited about what that team is able to deliver. And based on their history and the expanded efforts they've made, including increasing the sales force, I think there is a very good reason to believe that Japan is going to deliver starting next year.

整體而言，這類產品的國際銷售與營收通常約落在10%到15%的區間。我預期其中大部分會來自日本，而我對那個團隊能交付的成果感到非常振奮。而且基於他們的過往表現與已擴大的投入（包括增加銷售人力），我認為有非常充分的理由相信，日本將從明年開始貢獻成果。

Got it. Thanks, Will. And that implies Japan pricing is comparable to the US?

了解。謝謝，Will。那這是否意味著日本定價可與美國相當？

So the assumption is that we get a price from Japan that is acceptable. That is a process that is still underway. And when it's resolved, that's when we'll give full-throated support to the launch in Japan and its expected success.

所以我們的假設是，日本會給出一個可接受的價格。這個流程仍在進行中。等到塵埃落定，我們才會對日本上市及其預期成功給予全力支持。

Great. Thank you so much.

很好。非常感謝。

Matt Phipps, William Blair.

Matt Phipps，William Blair。

Thanks for taking my question, and congrats on great execution here. Last quarter, there was a lot of talk about ready and wait patients versus organic demand. So just wondering if the 7,000 patients you feel really fits into that organic demand category you described previously and if that should be the assumption for the rest of the year. Thank you.

謝謝讓我提問，也恭喜你們在這裡執行得非常出色。上一季大家談了很多所謂「ready and wait」病患與自然需求（organic demand）之間的差異。所以我想請教，你們認為的7,000名病患，是否確實屬於你們先前描述的那種自然需求類別？以及這是否應該作為今年剩餘時間的假設？謝謝。

Yeah. It is 100% organic demand. Ready and waiting patients are gone. There are no more. And that was a comment we made last quarter, and we stick to it from now and going forward. So all the 7,000 new patient starts that we saw this quarter and expect to see in future quarters will be organic demand.

是的。這是 100% 的自然需求。已準備好、在等待的病患已經不在了。已經沒有了。這是我們上季做過的評論，我們從現在起以及未來都會堅持這個看法。因此，本季我們看到的 7,000 名新病患開始用藥，以及我們預期未來各季會看到的，都將是自然需求。

Great. Thank you.

很好。謝謝。

Ben Burnett, Wells Fargo.

Ben Burnett，富國銀行。

Hi. Good morning. I want to ask one on TPIP and just back to one of your prior comments that the sales potential that you outlined could include IPF among other things. But with regards to IPF, I guess, what gives you the confidence that you would be able to navigate around a potential TYVASO ODE?

嗨。早安。我想問一個關於 TPIP 的問題，並回到你先前的一個評論：你所概述的銷售潛力可能包含 IPF 等其他項目。但就 IPF 而言，我想問，你們的信心來自哪裡，認為自己能夠繞開潛在的 TYVASO ODE？

Yeah, and I'll ask Martina to chime in here in a second. I think there are many ways you can -- I guess, the way to say it is to break the orphan status of a particular product. And we feel we have a number of different levers and approaches we can use there. Certainly, the Phase 2 data, the once-a-day dosing, many different features of this product and what it can do for patients, I think, presents an almost self-evident case for why we're superior.

是的，我等一下也請 Martina 在這裡補充。我認為有很多方式可以——我想可以這麼說——去打破某個產品的孤兒藥地位。我們覺得自己有多種不同的槓桿與方法可以運用。當然，二期數據、每日一次給藥、這個產品的許多不同特性以及它能為病患帶來的效益，我認為幾乎是不言自明地說明了為什麼我們更具優勢。

But Martina, do you want to add any comments?

不過 Martina，你想補充幾點嗎？

Yeah. I think one thing I would add here is that you've seen that the agency, the FDA here, has also recognized the potential and possible hypothesis that TPIP is clinically superior. We don't know, but we assume and we've seen some of those that there may also be better safety and tolerability that we can show.

好的。我想在這裡補充的一點是，你們也看到主管機關——也就是 FDA——已經認可 TPIP 具有臨床優越性的潛力與可能的假設。我們還不知道，但我們推測、也從一些跡象看到，我們也可能能證明其安全性與耐受性更佳。

And the third element is how you might impact patient care. Now, a once-daily drug with a better PK profile certainly would be one of them. That's the reason we have received also the PAH orphan drug designation because the agency already recognized the potential for TPIP. Again, I want to emphasize that we are a molecular different design as a prodrug has that potential opportunity for superiority.

第三個要素是你如何影響病患照護。那麼，一個每日一次、且具有更佳藥物動力學（PK）特徵的藥物，當然會是其中之一。這也是我們獲得 PAH 孤兒藥資格認定的原因，因為主管機關已經認可 TPIP 的潛力。再次強調，我們在分子設計上不同，作為前驅藥（prodrug）具備那樣的優越性機會。

Thanks so much.

非常感謝。

Maxwell Skor, Morgan Stanley.

Maxwell Skor，摩根士丹利。

Great. Thank you very much for taking my question. So you reiterated cash flow positivity in 2027, even with increased second-half spend on DTC and launching in Japan. Can you just give us a sense of what's the BRINSUPRI level that underpins that? And how much flexibility do you have if you pursue BD? Thank you.

很好。非常感謝你們回答我的問題。你們重申 2027 年現金流轉正，即使下半年增加 DTC 支出並在日本上市。能否請你們讓我們了解一下，支撐該判斷的 BRINSUPRI 水準大概是什麼？以及如果你們推進 BD（商務拓展），你們有多大的彈性？謝謝。

Sara, do you want to take that one?

Sara，你要回答這題嗎？

Sure, happy to. Thanks for the question, Max. Yes, we reiterated cash flow positivity in 2027. I obviously will not comment specifically on what revenue guide that is implying for BRINSUPRI for 2027. But we feel like the trajectory of this launch is going extremely well, as you could see in our revenue guide increase for this year and our peak sales revenue guide overall and that we have confidence in cash flow positivity through 2027 to fund our current business, as well as the items that we have in our pipeline, without raising additional capital.

當然，很樂意。謝謝你的問題，Max。是的，我們重申 2027 年現金流轉正。我顯然不會具體評論這對 2027 年 BRINSUPRI 的營收指引意味著什麼。但我們認為這次上市的走勢非常好，正如你們從我們今年上調的營收指引、以及我們整體峰值銷售營收指引所看到的；我們也有信心在 2027 年前後達成現金流轉正，以支應我們目前的業務，以及我們研發管線中的項目，而無需再額外募資。

Andy Chen, Wolfe Research.

Andy Chen，Wolfe Research。

Hey. This is Brandon on for Andy, and thanks for taking the question. So curious to know, what was the reason for the lower GTN? Was it Medicare patients fewer than previously anticipated, rebates less stringent than previously anticipated? Curious to know on that front. Thank you.

嗨。我是代 Andy 提問的 Brandon，謝謝你們回答問題。我想了解，GTN 較低的原因是什麼？是 Medicare 病患少於先前預期、回扣（rebates）沒有先前預期那麼嚴格，還是其他原因？想請教這方面的情況。謝謝。

Sara, over to you.

Sara，交給你。

Yeah, sure. So we obviously provided a GTN earlier in the launch. Now that we're in the midpoint of the year and we have a clear line of sight into contracting for the year, we have confidence in being able to narrow that range, tighten that range to the mid- to high-20s.

好的。我們在上市初期確實提供過一個 GTN 的區間。現在我們已到年中的時間點，且對全年合約談判有清楚的能見度，因此我們有信心能縮小該區間、把範圍收斂到 20% 中段到高段。

Importantly, access for patients is going great. I commented earlier around 90% payer approval, less than a week for the majority of patients, and that is the most important. So we're able to have this sort of narrow tightened GTN, and patient access is exactly where we want it to be.

重要的是，病患的可及性表現非常好。我先前提到大約 90% 的付款方核准率，多數病患在一週內就能完成，這才是最重要的。因此我們能把 GTN 收斂得更窄、更緊，而病患可及性也正如我們所希望的那樣。

Stephen Willey, Stifel.

Stephen Willey，Stifel。

Yeah. Good morning, and congrats on the execution. So just given what we know about treprostinil dose dependency, can you comment on how you're powering the Phase 3 TPIP trials might contemplate the percentage of patients that you're expecting to be titrated up to the highest 1,280 dose. And are you expecting those percentages to be meaningfully different across the different disease states? Thanks.

是的。早安，也恭喜你們執行得很到位。鑑於我們對 treprostinil 劑量依賴性的了解，你們能否談談在三期 TPIP 試驗的統計檢定力設計上，是否會考量預期有多少比例的病患會被滴定到最高的 1,280 劑量？以及你們是否預期不同疾病狀態之間，這些比例會有顯著差異？謝謝。

Yeah, so I'll turn this one over to Martina to talk about it. It's really important that people understand that the objective of the trial is not, per se, to push people up to the highest possible dose. It's for the physician to know that they have the flexibility that they can increase dose to achieve the ultimate best outcome for that particular patient. Patients respond to these drugs differently. And it's a very unique and unusual disease state where the FDA permits that kind of a dosing regimen.

好的，這題我交給 Martina 來說明。大家需要理解的一點非常重要：試驗的目標並不是——就其本身而言——把病患推到最高可能劑量。而是讓醫師知道他們有彈性，可以透過增加劑量來為特定病患達到最佳最終結果。病患對這些藥物的反應不同。而且這是一個非常獨特、也不常見的疾病領域，FDA 允許這種給藥調整方案。

But what we can do with 1,280 micrograms as the upper end is give them that room, that head space to continue to increase the dose should they not be able to achieve the best possible outcome at a lower dose. And if we look at just some of the recent data that we put out for TPIP, 25% of these patients in PAH in the OLE study get to Class 1, which means they have no symptoms of the disease.

我們能做的是把上限設在 1,280 微克，給醫師那個空間、那個餘裕：如果病患在較低劑量無法達到最佳可能結果，仍可繼續加量。如果我們看 TPIP 最近公布的一些數據，在 OLE 研究中，PAH 病患有 25% 達到第 1 級（Class 1），也就是沒有疾病症狀。

That is a remarkable increase in outcome for what is a fatal condition. And it is facilitated by this medicine and that extra room you have to increase dose. And that is something we want physicians to understand can happen with a modest side effect profile here. And that, too, was one of the remarkable things in the open-label extension study.

對於一種致命疾病而言，這是非常顯著的療效提升。這是由這個藥物以及你能夠加量的額外空間所促成的。這也是我們希望醫師理解的：在這裡相對溫和的副作用特徵下，確實可能達到這樣的結果。而這也是開放標籤延伸研究中另一個令人印象深刻之處。

But let me flip it over to Martina, who can perhaps dive a little deeper.

不過我把問題交給 Martina，她或許可以再深入一些。

Yeah. So when you think about how we designed the trial, you design the trial from a regulatory perspective, what do we need to show? Functional improvement, and that is the six-minute walk test. And that's what we are also powering for. We're powering the trial with a very high confidence of 96% to get a treatment difference of 30 meters, and that is at a p-value of 0.05.

好的。當你思考我們如何設計試驗時，是從法規角度來設計：我們需要證明什麼？功能性改善，而這就是六分鐘步行測試。這也是我們用來做統計檢定力設計的依據。我們以非常高的信心度 96% 來設計試驗，以在 p 值 0.05 的條件下，檢出 30 公尺的治療差異。

So what we are looking for is that patients in the trial have the opportunity to reach the dose that they need to be in a better clinical state and to reach a better functional class, as well as a risk score. Because in the real world, that is how physicians decide whether they will change or increase a treatment for patients when it comes to prostanoid treatment. So if you think about what we've looked at in the open-label extension, which is over 12 months, 77% of these patients have not only reached doses of at least 640, but they also maintained that dose.

因此，我們希望看到的是，試驗中的患者有機會達到他們所需要的劑量，以獲得更好的臨床狀態、提升功能分級，以及改善風險評分。因為在真實世界中，當涉及前列環素類（prostanoid）治療時，醫師就是依此來決定是否要為患者調整或加大治療。所以，如果你回顧我們在超過12個月的開放標籤延伸試驗中所觀察到的結果，這些患者中有77%不僅達到了至少640的劑量，且也維持了該劑量。

So what's important for us and for these patients are to have a runway that they can increase dose if they need to. That enables patients and physicians to potentially keep patients on a drug like TPIP for longer. They may not have to go on a pump and that of IV or parenteral treprostinil. That is a huge burden. That is what we're really looking for to put patients in a better clinical state, but we're powering for an approvable endpoint that is functional improvement.

因此，對我們以及這些患者而言，重要的是要有一段「跑道」，讓他們在需要時可以增加劑量。這使得患者與醫師有可能讓患者更長時間使用像TPIP這樣的藥物。他們可能不必改用幫浦輸注的靜脈（IV）或腸胃外（parenteral）曲前列尼爾（treprostinil）。那會是非常沉重的負擔。這正是我們真正想要達成的：讓患者處於更好的臨床狀態；但我們在統計設計上所要達成、可用於核准的終點，是功能改善。

All right. That's helpful. Thank you.

好的。這很有幫助。謝謝。

Qize Ding, Rothschild & Company Redburn.

Qize Ding，Rothschild & Company Redburn。

Congrats on the results. Thanks for taking my question. I have one on the capital allocation. So given your balance sheet and active internal programs, going forward, how do you balance the development of your internal pipeline assets versus looking now for external opportunities?

恭喜這些結果。謝謝讓我提問。我有一個關於資本配置的問題。鑑於你們的資產負債表以及活躍的內部專案，往後你們如何在內部管線資產的開發與推進，與現在尋找外部機會之間取得平衡？

Yeah. I appreciate the question. I think this is always the challenge that every biotech company faces, especially as it progresses. We are in the enviable position that we have three very substantial franchises that are in the same therapeutic area in the respiratory field. And we also have, for the last four years, a very developed research program across four different platforms that are now beginning to yield clinical drug candidates.

是的。謝謝你的提問。我認為這一直是每一家生技公司都會面臨的挑戰，尤其是在公司持續發展的過程中。我們很幸運，因為我們在呼吸領域同一治療範疇內擁有三個非常重要的產品/業務特許經營（franchises）。此外，在過去四年，我們也建立了一個非常成熟的研究計畫，涵蓋四個不同的平台，而這些平台現在開始產出臨床藥物候選物。

The criteria for internal development and advancement is that the medicine in question is either first or best in class. And next year, we will be able to share with you the clinical trial results of our first programs emerging from this research area, which include a gene therapy for ALS, a gene therapy for Duchenne muscular dystrophy, and as we mentioned today, entering the clinic just now INS1033, a new next-generation DPP1 for the treatment initially of rheumatoid arthritis and then ulcerative colitis and COPD. So there is more to come from this internal research pipeline.

內部開發與推進的標準是：相關藥物必須是同類首創（first-in-class）或同類最佳（best-in-class）。而在明年，我們將能與各位分享從這個研究領域中最先產出的專案之臨床試驗結果，其中包括：一項用於ALS的基因治療、一項用於杜興氏肌肉失養症的基因治療，以及如我們今天提到的，剛進入臨床的INS1033——一款新一代DPP1，最初用於治療類風濕性關節炎，之後擴展至潰瘍性結腸炎與COPD。因此，這條內部研發管線後續還會有更多進展。

However, at the same time, we are constantly evaluating what is out there because we want to make sure that capital gets deployed against the best opportunities available. And so that, too, is a high bar. It must be first or best in class that we're bringing aboard, but we will continue to look and evaluate for those opportunities as well. But this is going to be something we're going to return to again and again as we update you on the progress of the programs coming out of our research department and their progress through the clinic set against what we see in the landscape of business development.

不過同時，我們也持續評估外部有哪些機會，因為我們希望確保資本能投入在可取得的最佳機會上。因此，這同樣是一個很高的門檻。我們要引進的也必須是同類首創或同類最佳；但我們也會持續尋找並評估這些機會。不過，隨著我們持續向各位更新研究部門專案的進展、以及它們在臨床中的推進情況，同時對照我們在商務開發版圖中所看到的機會，這將會是我們一再回到並持續討論的主題。

Okay. Thanks.

好的。謝謝。

Danielle Brill, Truist.

Danielle Brill，Truist。

Hi, guys. Good morning. Congrats on the execution, and thanks so much for the question. I did have a follow-up on the peak sales assumption.

嗨，各位。早安。恭喜執行成果，也非常感謝讓我提問。我確實有一個關於峰值銷售假設的追問。

So you noted the high-level rationale, but I'm curious if you could kind of break down what specific assumptions changed to move the needle from $5 billion to $7 billion at peak? Was it expansion of the diagnosed population, penetration, persistence, duration on therapy, or anything else? If you could just comment on what assumptions changed the most meaningfully, that would be helpful. Thank you.

你們提到了高層次的理由，但我想了解，你們是否能拆解一下，究竟是哪些具體假設的改變，讓峰值從50億美元提升到70億美元？是確診人數的擴大、滲透率、持續用藥（persistence）、治療期間長度，或其他因素嗎？如果你們能評論一下哪些假設的變動最具實質影響，會很有幫助。謝謝。

Thanks for the question. I think when it comes to BRINSUPRI, yes, we assume that the addressable market will continue to grow over time. And that's going to be driven by not only population growth, but increased diagnosis. We anticipate patients who are in the one or fewer exacerbation category to shift to a certain degree into the two or more exacerbation category, and that's because of improved awareness and reporting of exacerbations. We also think that, over time, as this medicine's reputation continues to expand, that the default will be to turn to bronchiectasis patients and think of BRINSUPRI in their treatment.

謝謝你的提問。我認為就BRINSUPRI而言，是的，我們假設可觸及市場（addressable market）會隨時間持續成長。這將不僅由人口成長所驅動，也會由診斷率提升所帶動。我們預期，原本屬於一年一次或更少惡化（exacerbation）類別的患者，會在一定程度上轉移到一年兩次或以上惡化的類別，原因是對惡化事件的認知與回報有所改善。我們也認為，隨著這款藥物的口碑持續擴散，未來在治療支氣管擴張症患者時，預設選項將會是想到BRINSUPRI並將其納入治療考量。

I would also say that, as we look internally at our modeling efforts, what we have seen is remarkable alignment with what our commercial effectiveness team has forecast. And I have to call them out for the exceptional work that they have done associated with this launch. It allows us to be confident in our presentation of today's new and improved numbers, and it is driven by both strong and stable performance across all the main metrics that we track.

我也想補充的是，從我們內部的模型推估來看，我們所看到的結果與商業效能團隊的預測高度一致。我必須特別肯定他們在這次上市相關工作中所做的卓越表現。這讓我們對於今天所呈現、更新且更佳的數字更有信心；而這些數字是由我們所追蹤的所有主要指標上強勁且穩定的表現所驅動。

And this concludes today's conference call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝各位的參與。您現在可以掛線。