Theravance Biopharma Inc (TBPH) 2024 Q3 法說會逐字稿

Ladies and gentlemen, good afternoon.

女士們、先生們，午安。

I'd like to welcome everyone to the Theravance Biopharma third- quarter 2024 conference call.

歡迎大家參加 Theravance Biopharma 2024 年第三季電話會議。

(Operator instructions) Also, today's conference call is being recorded.

（操作員說明）另外，今天的電話會議正在錄音。

And now I'd like to turn the conference over to Rick Winningham, Chief Executive Officer.

現在我想將會議交給執行長 Rick Winningham。

Please go ahead, sir.

請繼續，先生。

Good afternoon, and welcome to Theravance Biopharma's third-quarter 2024 earnings results conference call.

下午好，歡迎參加 Theravance Biopharma 2024 年第三季財報電話會議。

I encourage you to review our forward-looking statements disclaimer on slide 2, which covers certain risk factors, which could cause actual results to differ materially from any forward-looking statements that we might make in today's call, and which are described further in our filings with the SEC.

我鼓勵您查看幻燈片2 上的前瞻性聲明免責聲明，其中涵蓋了某些風險因素，這些因素可能導致實際結果與我們在今天的電話會議中可能做出的任何前瞻性聲明存在重大差異，這些聲明將在我們的聲明中進一步描述。

You will find today's agenda on slide 3, along with members of the Theravance leadership team who will join me on the call today.

您可以在投影片 3 上找到今天的議程，以及今天將與我一起參加電話會議的 Theravance 領導團隊成員。

These are Rhonda Farnum, Chief Business Officer; Aziz Sawaf, Chief Financial Officer; and Aine Miller, Head of Development.

他們是首席商務官朗達·法納姆 (Rhonda Farnum)；阿齊茲·薩瓦夫，財務長；和 Aine Miller，開發主管。

Now if you turn to slide 4, I'd like to cover our most recent operational and financial results.

現在，如果您翻到投影片 4，我想介紹我們最近的營運和財務表現。

Starting on the left, we're pleased to have delivered sequentially improved YUPELRI quarterly net sales performance in partnership with Viatris, having driven 7% growth year-on-year and 14% quarter-on-quarter to $62.2 million and a new launch-to-date high.

從左邊開始，我們很高興與 Viatris 合作，YUPELRI 季度淨銷售額業績連續改善，同比增長 7%，環比增長 14%，達到 6220 萬美元，並推出了新產品-迄今為止的高點。

Third quarter YUPELRI demand increased 14% and hospital doses increased 40% versus the same period a year ago.

與去年同期相比，第三季 YUPELRI 需求增加了 14%，醫院劑量增加了 40%。

Second, we made solid progress on our pivotal CYPRESS study for ampreloxetine and remain on target to achieve our updated timelines.

其次，我們在安普洛西汀的關鍵 CYPRESS 研究方面取得了紮實進展，並繼續朝著實現更新時間表的目標邁進。

Lastly, GSK delivered another good TRELEGY result, reaching $789 million for the quarter and putting us in a position to achieve the higher $50 million 2024 sales milestone should fourth quarter sales exceed approximately $610 million, which is well below consensus estimate.

最後，GSK 再次取得了良好的TRELEGY 業績，該季度達到7.89 億美元，如果第四季銷售額超過約6.1 億美元（遠低於共識預期），我們就有能力在2024 年實現更高的5,000 萬美元銷售里程碑。

If achieved, Theravance would expect to receive this milestone in the first half of 2025.

如果實現的話，Theravance 預計將在 2025 年上半年實現這一里程碑。

Turning to slide 5, I'd like to cover two initiatives our Board has approved relating to our ongoing efforts to unlock value of Theravance Biopharma.

轉向投影片 5，我想介紹我們董事會已批准的兩項舉措，這些舉措與我們不斷努力釋放 Theravance Biopharma 的價值有關。

These reflect our willingness to proactively implement measures aligned with the interest of our shareholders while sharpening our operational focus and pursuit of delivering innovation to medicines, to patients with the highest unmet medical need.

這些反映了我們願意積極實施符合股東利益的措施，同時加強我們的營運重點和追求為藥品和未滿足醫療需求最高的患者提供創新。

First, in keeping with our regular review and updating of governance practices, we announced that the Board of Directors has separated the role of CEO and Chair and that Susannah Gray has been elected Chair of the Board of Theravance Biopharma.

首先，根據我們對治理實踐的定期審查和更新，我們宣布董事會已將執行長和董事長的角色分開，並選舉 Susannah Gray 為 Theravance Biopharma 董事會主席。

I'll continue my focus and my efforts on Theravance's mission as a Director and CEO.

作為董事兼首席執行官，我將繼續專注並努力實現 Theravance 的使命。

Susannah's unique experiences and skill set make her a natural choice to lead the Board moving forward as she brings over 30 years of experience in the biopharmaceutical industry, specializing in capital markets and corporate finance.

Susannah 獨特的經驗和技能使她成為領導董事會前進的自然選擇，因為她在生物製藥行業擁有 30 多年的經驗，專門從事資本市場和企業融資。

Second, we announced today that the Board of Directors has formed a Strategic Review Committee consisting of independent directors with the purpose of comprehensively exploring alternatives available to the company involving all of its key assets, including YUPELRI, Ampreloxetine, TRELEGY and its tax attributes.

其次，我們今天宣布，董事會已成立由獨立董事組成的策略審查委員會，旨在全面探索公司可採用的替代方案，涉及公司所有關鍵資產，包括 YUPELRI、氨普洛西汀、TRELEGY 及其稅務屬性。

Lazard will be acting as a financial adviser to assist in this review process.

Lazard 將擔任財務顧問，協助審查過程。

As we've stated consistently, Theravance's Board regularly considers options to enhance the company's strategic positioning, and we believe that forming the Strategic Review Committee highlights our focus on unlocking value and aligns with our shareholders' best interest.

正如我們一貫指出的那樣，Theravance 董事會定期考慮增強公司策略定位的方案，我們相信，成立策略審查委員會凸顯了我們對釋放價值的關注，並符合股東的最佳利益。

Lastly, as we previously communicated, we remain committed to returning excess capital to shareholders.

最後，正如我們之前所傳達的，我們仍然致力於將多餘的資本回饋給股東。

Now I'd like to turn the presentation over to Rhonda to cover YUPELRI's performance in the quarter.

現在我想將演講交給 Rhonda，介紹 YUPELRI 在本季的表現。

Rhonda?

朗達？

Thanks, Rick.

謝謝，瑞克。

I will begin with slide 7, where we present YUPELRI's quarterly net sales progression.

我將從幻燈片 7 開始，其中介紹了 YUPELRI 的季度淨銷售額進展。

Viatris reported 7% year-over-year growth in net sales, reaching approximately $62 million, which is an all-time high.

Viatris 報告淨銷售額年增 7%，達到約 6,200 萬美元，創歷史新高。

This growth was driven by a 14% increase in demand, exceeding expectations.

這一增長是由需求增長 14% 推動的，超出了預期。

Additionally, this quarter showed sequential improvement in pricing and channel mix relative to Q2.

此外，與第二季度相比，本季定價和通路組合有所改善。

And we have also seen a more recent increase to average selling price or ASP.

我們也看到最近平均售價（ASP）有所上升。

When we reported second quarter performance, we highlighted net pricing headwinds due to channel mix, specifically increased demand into lower-margin channels and onetime charges that impacted quarterly pricing.

當我們報告第二季業績時，我們強調了通路組合帶來的淨定價阻力，特別是對低利潤通路的需求增加以及影響季度定價的一次性費用。

In collaboration with Viatris, we are executing on strategies to deliver demand in higher-margin, non-retail channels, and we are confident these initiatives will continue to enhance net pricing and overall brand performance.

透過與 Viatris 合作，我們正在執行策略，以滿足高利潤、非零售通路的需求，我們相信這些舉措將繼續提高淨定價和整體品牌績效。

And as a reminder, we are limited in our ability to discuss certain elements of pricing given confidentiality considerations.

提醒一下，考慮到保密性，我們討論某些定價要素的能力有限。

Turning to slide 8.

轉到投影片 8。

We continue to experience considerable momentum in the hospital setting.

我們在醫院環境中持續保持強勁勢頭。

During the quarter, we shipped approximately 227,000 YUPELRI doses, up 40% compared with Q3 of 2023, and equivalent to our performance in Q2, which was particularly strong.

本季度，我們發貨了約 227,000 劑 YUPELRI 劑量，與 2023 年第三季度相比增長了 40%，與我們特別強勁的第二季度的表現相當。

Notably, this pattern is typical of the seasonality we see in our hospital business, where Q3 does not show as much sequential growth as in other quarters.

值得注意的是，這種模式是我們在醫院業務中看到的典型季節性，第三季的環比成長不如其他季度。

As a reminder, the strategic objective for our focus in the hospital setting is to create the catalyst to drive post-discharge outpatient maintenance use of YUPELRI.

提醒一下，我們在醫院環境中關注的策略目標是創造催化劑，推動出院後門診維持使用 YUPELRI。

Supporting that objective, we continued to broaden our base of formulary wins and implementation of therapeutic interchange protocols to position patients to continue their treatment after leaving the hospital.

為了支持這一目標，我們繼續擴大處方勝利的基礎並實施治療互換協議，以使患者在出院後繼續接受治療。

Based on our historical experience and a better than expected rate of formulary and new account wins in the quarter, we expect a strong finish to the year and continued momentum into 2025.

根據我們的歷史經驗以及本季處方藥和新帳戶贏取率好於預期的情況，我們預計今年將取得強勁業績，並將繼續保持這一勢頭直至 2025 年。

On slide 9, you can see how our hospital performance has contributed to share gains within the hospital long acting NEB market on the left-hand side.

在投影片 9 上，您可以在左側看到我們醫院的業績如何為醫院長效 NEB 市場的份額成長做出貢獻。

Based on data through the end of the quarter, we are up to a nearly 19% share, which is a new all-time high.

根據截至本季末的數據，我們的份額達到近 19%，這是歷史新高。

As it relates to our concomitant use messaging and the goal of driving to a 2:1 ratio of NEB, LABA to YUPELRI use over time, we continue to make good progress and ended the quarter at a 3:1 ratio.

由於它與我們的伴隨使用訊息傳遞以及隨著時間的推移推動NEB、LABA 與YUPELRI 使用比例達到2:1 的目標相關，因此我們繼續取得良好進展，並在本季度結束時達到3:1 的比例。

We see further opportunity for improvement in coming quarters, which should help us continue to contribute significantly to YUPELRI's overall growth.

我們看到未來幾季還有進一步改進的機會，這應該有助於我們繼續為 YUPELRI 的整體成長做出重大貢獻。

On the right-hand side of the slide, you can see YUPELRI's share development in the community setting.

投影片右側可以看到YUPELRI在社群設定中的分享發展。

As a reminder, we do not have a full data view by the time we report, so the 32% share we are presenting here only represents our performance through August.

提醒一下，截至我們發布報告時，我們還沒有完整的資料視圖，因此我們在這裡展示的 32% 份額僅代表我們截至 8 月的表現。

Given the demand generation we are seeing compared with trends we see for nebulized LABAs in the community setting, we are optimistic this trend will continue to develop favorably moving forward.

考慮到我們所看到的需求量與社區環境中霧化 LABA 的趨勢相比，我們樂觀地認為這一趨勢將繼續向前發展。

Moving on to slide 10.

繼續看投影片 10。

In addition to the substantial opportunity that still remains in the US, we also see significant potential to realize value in China, where Viatris filed an NDA in June.

除了美國仍然存在大量機會外，我們還看到了在中國實現價值的巨大潛力，Viatris 於 6 月在中國提交了 NDA。

The median time to review an NDA in China is approximately 15 months, and we stand to realize a $7.5 million milestone on approval.

在中國審查 NDA 的中位數時間約為 15 個月，我們預計將實現批准金額 750 萬美元的里程碑。

Additionally, we have the opportunity to earn up to $37.5 million of sales milestones and upwardly tiered royalties of between 14% and 20%.

此外，我們還有機會獲得高達 3,750 萬美元的銷售里程碑以及 14% 至 20% 的上調特許權使用費。

Finally, I will wrap up my comments on slide 11.

最後，我將總結我對投影片 11 的評論。

First, YUPELRI is a unique medicine, offering a substantial and highly differentiated value proposition.

首先，YUPELRI 是一種獨特的藥物，提供實質且高度差異化的價值主張。

It is the only nebulized LAMA for COPD maintenance treatment in the US, and we believe it is underutilized within the patient populations to which it is best suited.

它是美國唯一用於 COPD 維持治療的霧化 LAMA，我們相信它在最適合的患者群體中沒有得到充分利用。

We see long-term growth potential for the product, driving considerable value to Theravance shareholders.

我們看到該產品的長期成長潛力，為 Theravance 股東帶來可觀的價值。

Second, in addition to our co-promotion economics in the US, we potentially stand to achieve milestones and royalties as outlined here, which include those I referenced in the previous slide associated with the potential new opportunity in China.

其次，除了我們在美國的共同推廣經濟之外，我們還有可能實現此處概述的里程碑和特許權使用費，其中包括我在上一張幻燈片中提到的與中國潛在新機遇相關的那些。

At this point, I'll turn things over to Aziz for an update on TRELEGY.

此時，我將把有關 TRELEGY 的最新情況轉交給 Aziz。

Aziz?

阿齊茲？

Thanks, Rhonda.

謝謝，朗達。

I'll start on slide 13, where I'll discuss our potential to earn milestones for TRELEGY.

我將從幻燈片 13 開始，其中我將討論我們為 TRELEGY 贏得里程碑的潛力。

As reported by GSK, TRELEGY sales increased 17% in the quarter to $789 million. Year-to-date,

根據葛蘭素史克 (GSK) 報道，TRELEGY 本季銷售額成長 17%，達到 7.89 億美元。今年迄今，

this brings sales to $2.6 billion, up 30%.

這使得銷售額達到 26 億美元，成長 30%。

Based on year-to-date results, in Q4, we estimate that GSK needs approximately $260 million in sales for us to achieve the $25 million milestone and approximately $610 million in sales to achieve the $50 million milestone.

根據今年第四季迄今的業績，我們估計葛蘭素史克需要約 2.6 億美元的銷售額才能實現 2,500 萬美元的里程碑，並需要約 6.1 億美元的銷售額才能實現 5,000 萬美元的里程碑。

To put the $610 million requirement into perspective, this is $240 million or approximately 30% less than the consensus estimate of $850 million.

從 6.1 億美元的需求來看，這比共識估計的 8.5 億美元少了 2.4 億美元，約 30%。

We believe the recent performance for TRELEGY bodes well not just for the 2024 milestones, but also for the $150 million of additional milestones we could achieve in 2025 and 2026, where consensus estimates are significantly higher than the sales required to achieve the full $150 million of milestones.

我們相信TRELEGY 最近的表現不僅預示著2024 年的里程碑，而且也預示著我們可以在2025 年和2026 年實現1.5 億美元的額外里程碑，其中共識估計大大高於實現全部1.5 億美元所需的銷售額。

Given we are in a position to earn a milestone in 2024, I'd like to remind investors that achieving these milestones is tied to Royalty Pharma's receipt of TRELEGY royalties from GSK.

鑑於我們有能力在 2024 年實現一個里程碑，我想提醒投資者，實現這些里程碑與Royalty Pharma 從 GSK 獲得 TRELEGY 特許權使用費息息相關。

In order to make it easier for investors to track, we have provided an estimate of what net sales would need to be in order for these royalty thresholds to be met.

為了讓投資者更容易追踪，我們提供了滿足這些特許權使用費門檻所需的淨銷售額的估計。

For example, should 2024 net sales exceed $3.2 billion, we estimate that GSK would pay Royalty Pharma $275 million in royalties, which would trigger the $50 million milestone to Theravance.

例如，如果 2024 年淨銷售額超過 32 億美元，我們估計葛蘭素史克將向Royalty Pharma 支付 2.75 億美元的特許權使用費，這將觸發 Theravance 突破 5000 萬美元的里程碑。

Turning to slide 14, a reminder that in 2029, high-single-digit royalties on TRELEGY will revert back to Theravance, an asset we believe is often overlooked as a component of long-term value to shareholders.

轉向投影片 14，提醒人們到 2029 年，TRELEGY 的高個位數特許權使用費將回歸到 Theravance，我們認為這項資產作為股東長期價值的組成部分經常被忽視。

Now I'll hand it back to, I'll hand it to Aine to provide a brief update on Ampreloxetine.

現在我會把它交還給 Aine，提供關於氨普洛西汀的簡短更新。

Aine?

艾因？

Thanks, Aziz.

謝謝，阿齊茲。

I'll begin on slide 16.

我將從幻燈片 16 開始。

As we discussed on our last earnings call, we've been working with important academic institutions and affiliated MSA centers of excellence in order to deliver high-quality results for our Phase 3 pivotal study CYPRESS.

正如我們在上次財報電話會議上討論的那樣，我們一直在與重要的學術機構和附屬 MSA 卓越中心合作，以便為我們的第 3 階段關鍵研究 CYPRESS 提供高品質的結果。

The level of expertise at these sites ensures that the trial experience of these patients is well managed and enables us to both recruit and retain the appropriate number of patients we required to report out the CYPRESS study.

這些中心的專業水平確保這些患者的試驗體驗得到良好管理，並使我們能夠招募和保留報告 CYPRESS 研究所需的適當數量的患者。

During quarter 3, we were able to progress and open additional sites as planned.

在第三季度，我們能夠按計劃取得進展並開設更多站點。

We have enrolled patients over the quarter at a month-over-month (inaudible) that keeps us on track to achieve our objective of enrolling the final patient in the open-label portion of CYPRESS by the middle of next year and disclosing top line results of the study approximately six months later.

我們在本季度逐月招募患者（聽不清楚），這使我們能夠實現在明年年中之前將最終患者招募到 CYPRESS 開放標籤部分並披露頂線結果的目標大約六個月後進行該研究。

Turning to the bottom of the slide, we continue to engage the scientific community with presentations at both the International Parkinson's Disease and Movement Disorders Conference, also referred to as the MDS meeting, which took place in September, and the American Autonomic Society meeting held earlier this month.

轉向幻燈片底部，我們繼續在 9 月舉行的國際帕金森氏症和運動障礙會議（也稱為 MDS 會議）和早些時候舉行的美國自主學會會議上與科學界進行演示本月。

Our MDS presentation focused on safety and tolerability data observed in the long-term extension of Study 170.

我們的 MDS 演示重點關注在研究 170 的長期擴展中觀察到的安全性和耐受性數據。

Ampreloxetine was generally well tolerated by patients with nOH with only 10% of patients experiencing treatment-emergent adverse events considered related to ampreloxetine and no patient reporting supine hypertension.

nOH 患者對氨氯西汀的耐受性一般良好，只有 10% 的患者出現治療中出現的不良事件被認為與氨氯西汀相關，且沒有患者報告臥位高血壓。

Just 6% of the 110 patients evaluated in the study dropped out over a mean duration of exposure to ampreloxetine of approximately nine months.

在該研究中評估的 110 名患者中，只有 6% 在平均暴露於氨氯西汀約 9 個月的時間內退出。

A second analysis just presented at AAS evaluated data from our 0169 Study and highlighted the impact of nOH on symptom burden and daily functioning in patients with nOH.

剛剛在 AAS 上發表的第二項分析評估了我們 0169 研究的數據，並強調了 nOH 對 nOH 患者症狀負擔和日常功能的影響。

This analysis demonstrated greater baseline nOH symptoms in MSA as compared to other synucleinopathies, translating into higher symptom burden, reduced functioning and lower quality of life despite treatment with available pressor agents.

該分析表明，與其他突觸核蛋白疾病相比，MSA 的基線 nOH 症狀更大，儘管使用可用的升壓藥物進行治療，但仍會導致更高的症狀負擔、功能降低和生活品質降低。

A clear need for improved treatment alternatives remains in symptomatic nOH and MSA that we hope ampreloxetine will help address.

對於有症狀的 nOH 和 MSA，仍然明顯需要改進的治療替代方案，我們希望安普洛西汀能夠幫助解決這個問題。

On slide 17, I'll briefly remind you of where we stand with ampreloxetine.

在投影片 17 上，我將簡單提醒您我們在安普洛西汀的立場。

We've substantiated the significant unmet need, which we believe can be addressed with a targeted commercial effort.

我們已經證實了未滿足的重大需求，我們相信可以透過有針對性的商業努力來解決這個問題。

Approximately 40,000 patients with MSA in the United States suffer from symptoms of nOH and available therapies have significant efficacy and safety limitations.

在美國，大約 40,000 名 MSA 患者患有 nOH 症狀，現有療法具有顯著的療效和安全性限制。

We validated ampreloxetine target profile, which has clear differentiation from available alternatives used to treat nOH and MSA patients.

我們驗證了安普洛西汀的標靶概況，它與用於治療 nOH 和 MSA 患者的現有替代藥物有明顯的區別。

Our work to date on ampreloxetine supports its safety and tolerability profile and its ability to raise plasma norepinephrine and prevent symptom worsening.

迄今為止，我們對氨氯西汀的研究支持其安全性和耐受性，以及其提高血漿去甲腎上腺素和防止症狀惡化的能力。

We are aligned with FDA on requirements for a full approval should the CYPRESS study be positive, and we have obtained orphan drug designation in the United States.

如果 CYPRESS 研究呈陽性，我們與 FDA 一致同意獲得完全批准的要求，並且我們已在美國獲得孤兒藥資格。

We believe we are positioned to complete our regulatory filing quickl,y given we have already, given the work we've already completed.

我們相信，鑑於我們已經完成的工作，我們有能力快速完成監管備案。

Now I'll turn the presentation back to Aziz for our financial results and guidance.

現在我將向阿齊茲報告我們的財務表現和指導。

Aziz?

阿齊茲？

Thanks, Aine.

謝謝，艾因。

Starting off with the results for the quarter, slides 19 and 20 cover the detailed financials.

從本季的業績開始，投影片 19 和 20 介紹了詳細的財務數據。

I'll review the highlights on slide 21, where we had a solid quarter with slightly better-than-expected results across all key financial metrics.

我將回顧投影片 21 的重點內容，我們度過了一個穩健的季度，所有關鍵財務指標的結果都略好於預期。

Starting with collaboration revenue, we reported $16.9 million, above expectations, representing an 8% increase compared with last year.

從協作收入開始，我們公佈了 1,690 萬美元，超出預期，比去年增長 8%。

This quarter also marked an all-time high in product level profitability.

本季產品層面的獲利能力也創下歷史新高。

Total operating expenses, excluding share-based comp, saw a modest year-over-year increase due to the progression of the CYPRESS study, but were slightly better than expectations.

由於 CYPRESS 研究的進展，總營運費用（不包括股票補償）較去年同期略有成長，但略優於預期。

And while our R&D expenses increased, thanks to cost-savings initiatives, G&A expenses decreased by 7% in the quarter and 21% year-to-date compared with last year, positioning us to achieve our goal of a 20% reduction for the year.

雖然我們的研發費用有所增加，但得益於成本節約舉措，與去年相比，本季的一般管理費用減少了7%，年初至今減少了21%，這使我們能夠實現今年減少20% 的目標。

We reported $5 million in share-based comp for the quarter, another 21% reduction when compared with last year.

我們報告本季的股權補償為 500 萬美元，與去年相比又減少了 21%。

This, again, puts us on track with both our G&A and share based comp reduction targets for the year.

這再次使我們能夠實現今年的一般行政費用和基於股份的補償削減目標。

During the quarter, we incurred a $1.6 million noncash impairment charge due to the write-down in the value of our operating lease assets related to our excess lab space.

本季度，由於與超額實驗室空間相關的經營租賃資產價值減記，我們產生了 160 萬美元的非現金減損費用。

Given current market conditions, we took a conservative approach and wrote down the full remaining value of the lease related to our excess lab space.

鑑於當前的市場狀況，我們採取了保守的方法，並減記了與我們多餘的實驗室空間相關的租賃的全部剩餘價值。

We closed the period with $91 million of cash and 49 million shares outstanding.

本期結束時，我們持有 9,100 萬美元現金和 4,900 萬股已發行股票。

On slide 22, I'll comment on our expected financial performance in the fourth quarter and full year 2024.

在投影片 22 上，我將評論我們第四季和 2024 年全年的預期財務表現。

We are reaffirming guidance made at the beginning of the year and expect R&D expenses in Q4 to be slightly higher than Q3 due to the continued progression of the CYPRESS study and for SG&A expenses to be similar to Q3.

我們重申年初制定的指導意見，由於 CYPRESS 研究的持續進展，預計第四季度的研發費用將略高於第三季度，且 SG&A 費用將與第三季度相似。

For the full year, this would put us near the midpoint of guidance for both R&D and SG&A.

就全年而言，這將使我們接近研發和銷售、一般管理費用指引的中點。

Furthermore, we expect our non-GAAP results and cash burn in Q4 to be consistent with Q3.

此外，我們預計第四季度的非公認會計準則業績和現金消耗將與第三季保持一致。

Finally, as was the case last year, we expect to incur a higher non-cash tax charge sequentially in Q4, primarily due to better than expected results and other noncash charges from one of our operating entities.

最後，與去年的情況一樣，我們預計第四季度將連續產生更高的非現金稅費，這主要是由於我們的一個營運實體的業績好於預期以及其他非現金費用。

Looking ahead to 2025, our minimal cash burn enables us to progress the CYPRESS study to a major value inflection point without relying on the capital markets.

展望 2025 年，我們最小的現金消耗使我們能夠在不依賴資本市場的情況下將 CYPRESS 研究推進到一個主要的價值轉折點。

Our focus remains on driving growth through disciplined investment and delivering long-term value to shareholders.

我們的重點仍然是透過嚴格的投資來推動成長，並為股東提供長期價值。

With that, I'll pass it back to Rick to conclude.

這樣，我會將其傳回給 Rick 進行總結。

Rick?

瑞克？

Thanks, Aziz.

謝謝，阿齊茲。

I'll conclude on slide 23 by covering the main strategic elements of our plan to maximize the value of Theravance Biopharma while delivering on our core mission of delivering medicines that make a difference to patients.

我將在投影片 23 中總結我們計劃的主要策略要素，以最大限度地提高 Theravance Biopharma 的價值，同時履行我們的核心使命，即提供為患者帶來改變的藥物。

First, a top priority is always to maximize the number of appropriate patients on YUPELRI who could benefit from its significant lung function improvement delivered via nebulization over a full 24 hours.

首先，首要任務始終是最大限度地增加 YUPELRI 合適患者的數量，這些患者可以從透過 24 小時霧化帶來的顯著肺功能改善中受益。

Based on our market research, we continue to see a considerable opportunity to expand YUPELRI's utilization in the United States, and we're optimistic about its growth moving forward.

根據我們的市場研究，我們繼續看到擴大 YUPELRI 在美國使用的巨大機會，並且我們對其未來的成長持樂觀態度。

Second, we're progressing well with both CYPRESS enrollment and our regulatory and early commercialization preparations for ampreloxetine in nOH and MSA and are looking forward to delivering important milestones in 2025.

其次，我們在 CYPRESS 註冊以及 nOH 和 MSA 中氨普羅西汀的監管和早期商業化準備方面進展順利，並期待在 2025 年實現重要的里程碑。

Third, we're dedicated to maximizing value for shareholders.

第三，我們致力於為股東實現價值最大化。

We're excited with the trends that we've seen in TRELEGY and the potential milestones that could accrue to the company.

我們對 TRELEGY 中看到的趨勢以及公司可能實現的潛在里程碑感到興奮。

We're managing our expenses carefully and expect to limit cash utilization moving forward.

我們正在謹慎管理我們的開支，並預計未來將限制現金的使用。

The Board has formed a Strategic Review Committee to evaluate all alternatives available to Theravance to unlock the significant value of Theravance's assets given our view that much of the intrinsic value is not currently reflected in our share price.

鑑於我們認為大部分內在價值目前並未反映在我們的股價中，董事會已成立戰略審查委員會來評估 Theravance 可用的所有替代方案，以釋放 Theravance 資產的巨大價值。

And finally, we remain committed to returning excess capital to shareholders.

最後，我們仍然致力於將多餘的資本回饋給股東。

We thank you for your continued support.

我們感謝您一直以來的支持。

And at this time, we're ready to open the line for questions.

此時，我們已準備好開通提問專線。

(Operator Instructions)

（操作員說明）

Julian Harrison, BTIG.

朱利安·哈里森，BTIG。

Hi, Congrats on the quarter and thank you for taking question.

您好，恭喜本季度，感謝您提出問題。

First, I'm curious if you're seeing any changes in YUPELRI prescribing patterns post ensifentrine launch, either headwinds or tailwinds there?

首先，我很好奇您是否看到 ensifentrine 上市後 YUPELRI 的處方模式有任何變化，無論是逆風還是順風？

And then second, can you remind us where you stand on site activations for the CYPRESS study?

其次，您能提醒我們您在 CYPRESS 研究現場活化方面的立場嗎？

Are you at target now?

現在達到目標了嗎？

If not, how far away are you from that?

如果沒有，你離那個目標還有多遠？

Yes.

是的。

Sure, Julian.

當然，朱利安。

Thank you.

謝謝。

Rhonda, do you want to take the YUPELRI question and then Aine will follow?

Rhonda，你想回答 YUPELRI 問題，然後 Aine 來回答嗎？

Great.

偉大的。

Thanks for the question, Julian.

謝謝你的提問，朱利安。

As I've mentioned before, we're very excited to have other effort and share of voice in the marketplace, highlighting the importance of nebulization as an offering for patients.

正如我之前提到的，我們非常高興能夠在市場上做出其他努力並分享聲音，強調霧化作為患者產品的重要性。

And I think it's a little too early to see kind of the full gamut of what exact patients are getting what relative to ensifentrine.

我認為現在要全面了解患者所接受的與安西芬汀相關的治療方案還為時過早。

But I will say in kind of anecdotal feedback that we're hearing from the field, we are hearing that ensifentrine is being added on to YUPELRI and specifically multitude of examples of concomitant use, so LABA plus LAMA and then ensifentrine added on.

但我要說的是，我們從現場聽到的一些軼事反饋中，我們聽說 ensifentrine 正在被添加到 YUPELRI 中，特別是大量伴隨使用的例子，所以 LABA 加 LAMA，然後添加 ensifentrine。

I think as we get closer, maybe another quarter in, we'll have full visibility into the Med B prescribing and can be able to comment on that more readily.

我認為，隨著時間的推移，也許再過一個季度，我們將全面了解 Med B 的處方，並且能夠更輕鬆地對此發表評論。

Aine?

艾因？

Julian, very pleased to say that we are now in a position where we have the vast majority of our sites now activated.

Julian，非常高興地說，我們現在已經啟動了絕大多數網站。

You'll remember last quarter, we talked about the remaining number of key sites that we wanted to progress.

您會記得上個季度，我們討論了我們想要進展的關鍵站點的剩餘數量。

We've been in a position to progress them over the last quarter and almost all sites over the line at this point.

我們已經能夠在上個季度和幾乎所有網站上取得進展。

Excellent.

出色的。

Thank you and congrats again.

謝謝你並再次恭喜。

Ernie Rodriguez, TD Cowen.

厄尼·羅德里格斯，TD·考恩。

Hi team.

大家好。

Congratulations on your record quarter.

恭喜您季度創紀錄。

Thanks for taking our question.

感謝您提出我們的問題。

I start with, for YUPELRI, you mentioned the hospital doses sold increased by 40% year-to-year, and you also are increasing your market share.

首先，對於 YUPELRI，您提到醫院銷售的劑量比去年同期增加了 40%，您也在增加市場份額。

Could you give us more color on what's driving that and what the expectations are going forward as the year-to-year becomes like a harder comp?

您能給我們更多關於推動這一趨勢的因素以及隨著逐年變得更加困難的競爭而對未來的期望嗎？

Rhonda?

朗達？

Yes.

是的。

Thanks, Ernie.

謝謝，厄尼。

What continues to drive that growth, which we are very pleased with, is continuing to build upon the number of formulary approvals we have in the US, as well as when we are able to achieve a formulary that, that formulary also includes a therapeutic interchange, which I think you already appreciate that, that basically puts in place in the EMR system, the substitution for when a LAMA is prescribed that YUPELRI is the choice.

繼續推動這種增長的因素是我們在美國獲得的處方批准數量，以及當我們能夠實現處方中還包括治療互換的處方時，我們對此感到非常高興。這基本上已在EMR 系統中落實到位，當LAMA 開立處方時，可以選擇YUPELRI 來替代。

So seeing this last quarter that of our focus accounts, we have now moved up to 50% of those accounts have a therapeutic interchange.

因此，從上個季度我們的重點客戶來看，我們現在已經將其中 50% 的客戶進行了治療性交流。

So where we have therapeutic interchange, we have significantly higher market share.

因此，在我們進行治療互換的地方，我們的市佔率明顯更高。

So I commented that we're roughly at 19% for total market share.

所以我評論說我們的總市佔率大約是 19%。

Where we have therapeutic interchange, we are at 36% market share.

在我們進行治療互換的領域，我們的市佔率為 36%。

So it's getting those wins that are continuing to drive that effort in the hospital channel.

因此，這些勝利將繼續推動醫院管道的努力。

Got it.

知道了。

Thank you.

謝謝。

That's very useful.

這非常有用。

And then just another quick question on the committee, the newly formed committee to, that's assessing the strategic alternatives.

然後是關於委員會的另一個快速問題，新成立的委員會正在評估策略替代方案。

What prompted the initiative?

是什麼促使了這項舉措？

I guess, why now?

我想，為什麼現在呢？

And what would be the ideal outcome of options that you'd consider?

您考慮的選擇的理想結果是什麼？

Yes, Ernie, great question.

是的，厄尼，好問題。

Well, the Board is always evaluating the company's strategy against the both short-term and long-term goals.

嗯，董事會總是根據短期和長期目標來評估公司的策略。

If you look at where the company is today, and we've covered a number of the key elements of value in the company, namely the continued strength of TRELEGY, not only the $50 million milestone coming in to, for 2024 sales coming into frame and what we should be able to earn, but the other milestones in '25 and '26, as Aziz highlighted.

如果你看看公司今天的處境，我們已經涵蓋了公司的許多關鍵價值要素，即 TRELEGY 的持續實力，而不僅僅是 2024 年銷售額達到 5000 萬美元的里程碑正如阿齊茲強調的那樣，我們應該能夠獲得什麼，以及25 年和26 年的其他里程碑。

So you put TRELEGY and those milestones and longer term, the royalties coming back to us.

所以你把 TRELEGY 和那些里程碑以及從長遠來看，版稅還給我們。

You have YUPELRI growing in the United States, continuing to grow, and we've worked closely, as Rhonda said, with Viatris over the last quarter, sharpening up our execution sort of across the Board, and then the China approval and then slightly around 12 months or so from data, from a very important Phase 3 study with ampreloxetine in a rare neurological condition in CYPRESS and then you kind of close with the tax attributes.

YUPELRI 在美國不斷成長，持續成長，正如 Rhonda 所說，我們在上個季度與 Viatris 密切合作，全面加強了我們的執行力，然後獲得了中國的批准，然後略有提高大約12 個月左右的數據，來自CYPRESS 一項非常重要的氨普羅西汀治療罕見神經系統疾病的3 期研究，然後您就接近了稅收屬性。

The Board determined that now was just an appropriate time to undertake a formal review with Lazard's help of the options that are available to the company to unlock the value of those assets.

董事會認為，現在正是在 Lazard 的幫助下對公司可用於釋放這些資產價值的選擇進行正式審查的適當時機。

And given, we want to take a proactive approach that allows us to make informed decisions that will benefit our shareholders.

有鑑於此，我們希望採取積極主動的方法，使我們能夠做出明智的決策，使我們的股東受益。

So I think that's some substance of the action is we believe that our assets are appropriately valued.

因此，我認為該行動的實質內容是我們相信我們的資產得到了適當的估值。

The Board has got a Strategic Review Committee in place now to work with Lazard to map out a plan and actions to get better valuation out of those assets for the benefit of our shareholders.

董事會現已成立戰略審查委員會，與 Lazard 合作制定計劃和行動，以便更好地評估這些資產，從而造福我們的股東。

And the underlying business of Theravance is very strong, and we're optimistic about it.

而Theravance的底層業務非常強勁，我們對此持樂觀態度。

So we need to pull that value through to our shareholders.

因此，我們需要將這種價值傳遞給我們的股東。

Does that help?

這樣有幫助嗎？

Yes.

是的。

No, that's very helpful.

不，這非常有幫助。

Thank you for that and congrats again on the quarter.

謝謝您，並再次恭喜本季。

(Operator Instructions)

（操作員說明）

It appears we have no further questions on the phone.

看來我們在電話中沒有其他問題了。

I'd like to turn the conference back over to Mr. Winningham.

我想將會議重新交給溫寧漢先生。

Please go ahead, sir

請繼續，先生

Thank you, operator.

謝謝你，接線生。

Thanks, everyone, for participating and joining us in our third quarter update call and look forward to seeing all of you soon, and have a good day.

感謝大家參與並加入我們的第三季更新電話會議，並期待很快見到你們所有人，祝你們有美好的一天。

Pardon me, Mr. Winningham.

請原諒，溫寧漢先生。

We did have one person just queued up.

我們確實有一個人剛剛排隊。

Do you want to go ahead and take that question?

您想繼續回答這個問題嗎？

Yes.

是的。

Sure, one moment.

當然，一會兒。

Douglas Tsao, H.C. Wainwright.

雪兒 (Douglas Tsao)溫賴特。

Hi, good afternoon.

嗨，下午好。

Thanks for taking the questions.

感謝您提出問題。

So apologies in advance if this question has already been asked.

如果這個問題已經被問過，請先道歉。

But just curious, it looked like we sort of started to have a nice rebound with YUPELRI this quarter, certainly coming in ahead of our expectations.

但只是好奇，看起來我們在本季開始與 YUPELRI 實現良好的反彈，肯定超出了我們的預期。

Just curious the extent that you were able to make progress in terms of impacting the ASP and what that might mean for expectations heading into 2025.

只是好奇您在影響 ASP 方面取得的進展有多大，以及這對 2025 年的預期意味著什麼。

Thank you.

謝謝。

Rhonda, you want to take that?

朗達，你想要那個嗎？

Yes.

是的。

Thanks, Doug.

謝謝，道格。

I think relative to progress, as we've highlighted in the past, specifically to ASP, that's a two quarter lag of impact once there are any implications or initiatives that are put in place.

我認為，正如我們過去所強調的那樣，相對於進展，特別是 ASP，一旦實施任何影響或舉措，影響就會出現兩季的延遲。

So I think more of what was able to drive the success in Q3 was really looking at that further supplier diversification and the output of the channel deployment and execution very specifically across all channels, that being community, hospital, long-term care, et cetera.

因此，我認為，能夠推動第三季度成功的更多因素實際上是著眼於供應商的進一步多元化，以及非常具體地跨所有渠道（社區、醫院、長期護理等）的渠道部署和執行的輸出。

What I would say relative to the improvement in price relative to Q2 and the expectation, that overall price will continue to improve, that's more relative to early 2025.

我想說的是，相對於第二季的價格改善以及整體價格將繼續改善的預期，這更多是相對於 2025 年初而言的。

So you combine that with the strong demand growth we have been seeing now for two quarters straight.

因此，您將其與我們現在連續兩個季度看到的強勁需求成長結合起來。

We're just remaining very optimistic about net sales progression for the brand into 2025 and certainly beyond.

我們對該品牌到 2025 年甚至更長的淨銷售額進展仍然非常樂觀。

And I think, Doug, coming out of the second quarter.

我想，道格，從第二季開始。

The collaboration really with Viatris on pricing, on marketing and driving the business forward just has been excellent.

與 Viatris 在定價、行銷和推動業務發展方面的合作非常出色。

So I interrupted, you go ahead.

於是我打斷了你，你繼續。

No, no.

不，不。

I was going to say, Rick, I mean, so obviously, Rhonda, as you noted, there is a lag in terms of the reported ASP and that obviously affects what you're able to command in certain channels.

我想說，Rick，我的意思是，很明顯，Rhonda，正如您所指出的，報告的 ASP 存在滯後，這顯然會影響您在某些管道中的指揮能力。

But I'm just curious in terms of the sort of receptivity or impact on the customer base as you sort of try to pursue these initiatives and whether you experienced any resistance or were you able to sort of implement them without any kind of disruption from a volume standpoint?

但我只是好奇當你嘗試推行這些舉措時，客戶群的接受程度或影響，以及你是否遇到任何阻力，或者你是否能夠在沒有任何干擾的情況下實施這些舉措。

Or ruffling feathers is perhaps the better way to put it.

或者激怒羽毛也許是更好的表達方式。

Yes.

是的。

Well, it's always the goal to not ruffle feather.

好吧，不激怒羽毛始終是我們的目標。

So I would say, I would answer to the latter is the situation.

所以我想說，我會回答的是後者的情況。

You might just talk, Rhonda, briefly for Doug about the overall value, the value prop really for YUPELRI in the patients that we're treating in the hospital and the community.

朗達，你可以簡單地為道格談談 YUPELRI 對我們在醫院和社區治療的病人的整體價值，真正的價值支撐。

Yes.

是的。

Well, I think we've certainly highlighted in the past of where there continues to be what we feel is under realized opportunity within three different patient segments.

嗯，我認為我們過去確實強調過，我們認為在三個不同的患者群體中仍然存在尚未實現的機會。

And certainly, borrowing off of what I commented on relative to the concomitant use strategy, ensuring that where there is LABA use that we want to ensure that along with mirroring GOLD guidelines that adding that LAMA or YUPELRI is certainly in the consideration.

當然，借鑒我對伴隨使用策略的評論，確保在有 LABA 使用的情況下，我們希望確保與 GOLD 指南相一致，添加 LAMA 或 YUPELRI 肯定也在考慮範圍內。

So executing on that, improving that ratio, the goal is to get to 2:1 and continuing to see improvements in both the hospital and the community efforts there.

因此，執行該計劃，提高這一比例，目標是達到 2:1，並繼續看到醫院和社區努力的改善。

And then for those patients who already prefer nebulized therapy and recognize that concomitant use is certainly an option.

然後對於那些已經喜歡霧化治療並認識到聯合使用肯定是一種選擇的患者。

There are still those patients that are relying on short-acting NEB therapy to support what they feel is their maintenance care, but they are using a nebulizer 4 times to 6 times a day and still experiencing symptoms.

仍有一些患者依靠短效 NEB 治療來支持他們認為的維持治療，但他們每天使用霧化器 4 到 6 次，但仍然出現症狀。

So the goal is to continue to switch those patients from short-acting NEB, get those patients controlled and ensure that they're recognizing the value of a long-acting medication.

因此，我們的目標是繼續讓這些患者不再接受短效 NEB 治療，讓這些患者得到控制，並確保他們認識到長效藥物的價值。

And then lastly, for those patients that are receiving triple therapy, handheld often, most often, I should say, as a dry powder inhaler, we want to ensure that this patient population recognizing that dexterity, cognition difficulties are limiting their ability to use the device properly.

最後，對於那些經常接受三重療法的患者，我應該說，最常見的是，作為乾粉吸入器，我們希望確保這些患者群體認識到靈活性、認知困難限制了他們使用乾粉吸入器的能力。正確。

So this represents a primary reason of why we feel that there is an opportunity to educate on the value of changing device, which is easy to administer and offers a once daily option for these patients.

因此，這代表了我們認為有機會宣傳更換設備的價值的主要原因，該設備易於管理，並為這些患者提供了每天一次的選擇。

We feel like recognizing the value and the number of roughly 1.5 million patients that could stand to benefit from YUPELRI in addition to the 400,000 that represents the first two segments I just highlighted.

除了我剛才強調的前兩個細分市場的 40 萬患者之外，我們希望認識到大約 150 萬患者的價值和數量可以從 YUPELRI 中受益。

There is significant room to grow this brand.

這個品牌還有很大的發展空間。

Okay, great.

好的，太好了。

Thank you.

謝謝。

And that was our last question.

這是我們的最後一個問題。

I'm not sure if you finished your concluding comments, Mr. Winningham.

我不確定你是否完成了你的結論性意見，溫寧漢先生。

I did operator.

我做了操作員。

Thank you very much.

非常感謝。

Thank you for joining us.

感謝您加入我們。

You're welcome.

不客氣。

This concludes today's conference call.

今天的電話會議到此結束。

We thank you all for your participation.

我們感謝大家的參與。

You may now disconnect.

您現在可以斷開連線。