Liquidia Corp (LQDA) 2025 Q2 法說會逐字稿

Good morning, and welcome, everyone, to the Liquidia Corporation second-quarter 2025 financial results and corporate update conference call. My name is Nadia, and I will be your conference operator today. (Operator Instructions)

早安，歡迎大家參加 Liquidia Corporation 2025 年第二季財務表現及公司更新電話會議。我叫納迪亞，今天我將擔任您的會議主持人。（操作員指示）

I would like to remind everyone that this conference call is being recorded. I will now hand the conference call over to Jason Adair, Chief Business Officer. Please go ahead, sir.

我想提醒大家，本次電話會議正在錄音。現在我將電話會議交給首席商務官 Jason Adair。先生，請繼續。

Thank you, operator, and good morning, everyone. It's my pleasure to welcome you to the Liquidia Corporation second-quarter 2025 financial results and corporate update call. Joining the call today are Chief Executive Officer, Dr. Roger Jeffs; Chief Operating Officer and CFO, Michael Kaseta; Chief Medical Officer, Dr. Rajeev Saggar; Chief Commercial Officer, Scott Moomaw; and General Counsel, Rusty Schundler.

謝謝接線員，大家早安。我很高興歡迎您參加 Liquidia Corporation 2025 年第二季財務業績和公司最新情況電話會議。今天參加電話會議的有執行長 Roger Jeffs 博士、營運長兼財務長 Michael Kaseta、首席醫療官 Rajeev Saggar 博士、商務長 Scott Moomaw 和總法律顧問 Rusty Schundler。

Before we begin, please note that today's conference call will contain forward-looking statements, including those regarding future results, unaudited and forward-looking financial information and the company's future performance and or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause actual results or performance to differ materially.

在我們開始之前，請注意，今天的電話會議將包含前瞻性陳述，包括有關未來結果、未經審計和前瞻性財務資訊以及公司未來業績和/或成就的陳述。這些聲明受已知和未知的風險和不確定性的影響，可能導致實際結果或表現有重大差異。

For more information, please refer to the documents filed with the SEC available on our website. With that, I'd like to turn the call over to Roger for our prepared remarks. Roger?

欲了解更多信息，請參閱我們網站上提交給美國證券交易委員會的文件。說完這些，我想把電話交給羅傑，讓他發表我們準備好的發言。羅傑？

Thanks, Jason, and good morning, everyone. We are very pleased and excited to share our first commercial data for YUTREPIA with everyone this morning. It's been a spectacular beginning. Just over 11 weeks ago, we were proud to introduce YUTREPIA for the treatment of patients with pulmonary arterial hypertension, PAH, and pulmonary hypertension associated with interstitial lung disease, PH-ILD. Within 1 week of approval, we were live and in the market, shipping product, supporting physicians and most importantly, delivering therapy to patients.

謝謝，傑森，大家早安。我們非常高興和興奮今天早上與大家分享 YUTREPIA 的第一批商業數據。這是一個令人驚嘆的開始。就在 11 週前，我們自豪地推出了 YUTREPIA，用於治療肺動脈高壓 (PAH) 和與間質性肺病相關的肺動脈高壓 (PH-ILD) 患者。在獲得批准後的一周內，我們就開始在市場上銷售、運送產品、支持醫生，最重要的是，為患者提供治療。

This wasn't simply a product introduction. It was a launch executed with purpose and precision and one that has been extremely well received by the physician and patient communities that we now serve. Today, we will share data and as promised, provide additional granularity around key metrics to improve transparency regarding this early launch period. Since May, specialty pharmacies have reported over 900 unique patient prescriptions, leading to more than 550 patient starts on YUTREPIA.

這不僅僅是一次產品介紹。這次發表會執行得有目的、有步驟，受到了我們現在服務的醫生和患者群體的熱烈歡迎。今天，我們將分享數據，並按照承諾提供有關關鍵指標的更多詳細信息，以提高這一早期發布階段的透明度。自五月以來，專科藥局已報告超過 900 份獨特的患者處方，導致超過 550 名患者開始使用 YUTREPIA 治療。

That pace of adoption is unprecedented in the treprostinil space and underscores the power of our PRINT-enabled prostacyclin product. We had no doubt about the key attributes of YUTREPIA's profile to enhance deep lung delivery with an easy-to-use, low- effort device, enabling a wide range of doses. I can honestly say in all my years of launching drugs in this space, this has truly outpaced all expectations, even mine, which were very, very high.

這種採用速度在曲前列尼爾領域是前所未有的，凸顯了我們支持 PRINT 的前列環素產品的強大功能。我們毫不懷疑 YUTREPIA 的關鍵屬性，即透過易於使用、省力的設備增強深層肺部輸送，實現廣泛的劑量範圍。我可以誠實地說，在我在這個領域推出藥物的這些年裡，這確實超出了所有人的預期，甚至超出了我的預期，我的預期非常非常高。

Not only does this signal the value of what we have developed, but also that existing products fall short in addressing the needs of many patients. In conversations with prescribers and in communication from patients, the ease of use, tolerability, especially with regard to cough and ability to escalate dose to clinical effect represents a marked and meaningful improvement in the quality of care.

這不僅顯示了我們所開發產品的價值，而且顯示現有產品無法滿足許多患者的需求。在與處方醫生的對話和與患者的交流中，易用性、耐受性（尤其是在咳嗽方面）以及根據臨床效果增加劑量的能力代表了護理質量的顯著而有意義的改善。

YUTREPIA's differentiated product profile, paired with the commercial success in driving brand awareness has led to an early and enthusiastic uptake as you have seen in the prescription and start numbers. In fact, it's been an unabated sprint since day one of launch.

YUTREPIA 的差異化產品特性，加上在推動品牌知名度方面的商業成功，導致了早期的熱情採用，正如您在處方和起始數字中所看到的那樣。事實上，自從發布第一天起，我們就一直不懈地衝刺。

We've seen broad demand from cardiologists and pulmonologists with prescriptions occurring at both specialty centers and community practices, and they are treating a broad group of patients across both diseases who are prostacyclin naive, transitioning from TYVASO and TYVASO DPI and even moving from oral prostacyclins.

我們看到心臟科醫生和肺部疾病專家對處方的需求十分廣泛，無論是在專科中心還是在社區診所，他們正在治療大量患有這兩種疾病的患者，這些患者都是未使用過前列環素的患者、從 TYVASO 和 TYVASO DPI 過渡的患者，甚至是從口服前列環素過渡的患者。

YUTREPIA is truly off to a strong start and quickly positioning itself as potentially the best-in-class and first-in-choice option for patients in need of a prostacyclin therapy. Anticipating the strong interest, our market access team prepared premium white glove services and reimbursement support to allow patients to gain early access to YUTREPIA.

YUTREPIA 確實取得了良好的開端，並迅速將自己定位為需要前列環素治療的患者的最佳選擇和首選方案。預計到會有強烈的興趣，我們的市場准入團隊準備了優質的白手套服務和報銷支持，以便患者能夠儘早獲得 YUTREPIA 治療。

Health care providers have responded positively to the program's co-pay assistance and 28-day free vouchers, a first for an inhaled prostacyclin therapy. As a way of providing some insight, prescriptions received during the first six weeks of launch had a 75% script-to-start conversion rate. It's especially noteworthy that this early momentum has been achieved in spite of the customary period of new-to-market blocks and non-formulary positioning.

醫療保健提供者對該計劃的共同支付援助和 28 天免費代金券做出了積極回應，這是吸入前列環素療法的首創。為了提供一些見解，在推出後的前六週內收到的處方的處方轉換率為 75%。尤其值得注意的是，儘管經歷了常規的新產品上市階段和非處方藥定位階段，但仍取得了這一早期動能。

We see the potential for accelerating growth and possibly higher conversion rates as we continue to expand market access during the third and fourth quarters. While the commercial team has been driving YUTREPIA's robust update, our clinical team has been analyzing maturing data from the ongoing open-label ASCENT study, which was fully enrolled with 54 PH-ILD patients in March. This analysis includes the safety and observational exploratory efficacy data up to week 16.

隨著我們在第三季和第四季繼續擴大市場准入，我們看到了加速成長和可能提高轉換率的潛力。在商業團隊推動 YUTREPIA 強勁更新的同時，我們的臨床團隊一直在分析正在進行的開放標籤 ASCENT 研究的成熟數據，該研究於 3 月全面招募了 54 名 PH-ILD 患者。分析包括截至第 16 週的安全性和觀察性探索性功效數據。

The ASCENT study was intentionally designed to include a real-world PH-ILD population treated with YUTREPIA. In particular, we treated patients ranging from mild pulmonary hypertension to those with more advanced hemodynamic and forced vital capacity impairments and even patients listed for lung transplantation.

ASCENT 研究旨在納入使用 YUTREPIA 治療的真實世界 PH-ILD 族群。具體來說，我們治療的患者包括輕度肺動脈高壓患者、血流動力學和用力肺活量受損程度更嚴重的患者，甚至包括需要肺移植的患者。

The observations at week eigh and week 16 are indeed impressive. The tolerability remains very favorable as evidenced by the fact that only 18.5% of patients discontinued the study at week 16 with no discontinuations for serious or drug-related adverse events, including cough.

第八週和第十六週的觀察確實令人印象深刻。耐受性仍然非常好，因為只有 18.5% 的患者在第 16 週停止研究，沒有患者因嚴重或藥物相關不良事件（包括咳嗽）而停止研究。

For context, this favorable tolerability is juxtaposed by prospective data of Tyvaso DPI from the National Jewist Health Center, a preeminent pulmonary care center, where 69% of treatment-naive patients discontinued Tyvaso DPI in a median time of only 40 days with the primary reasons for discontinuation being cough and clinical worsening.

就背景而言，這種良好的耐受性與來自國家猶太健康中心（卓越的肺部護理中心）的 Tyvaso DPI 的前瞻性數據形成鮮明對比，其中 69% 的初治患者在平均僅 40 天的時間內停用 Tyvaso DPI，停藥的主要原因是咳嗽和臨床惡化。

Taking a slightly deeper look at the favorable tolerability that we are observing in the ASCENT study of those patients that reported a treatment-related cough, the vast majority or 24 of 26 patients reported mild cough and only two patients reported a moderate cough.

稍微深入觀察我們在 ASCENT 研究中觀察到的良好耐受性，那些報告出現治療相關咳嗽的患者，絕大多數（26 名患者中的 24 名）報告出現輕度咳嗽，只有兩名患者報告出現中度咳嗽。

However, it should also be noted that in the longitudinal analysis, the mean daytime simplified cough scores remained essentially unchanged from baseline through week 16, suggesting the cough overall tended to be transient in nature and not worsened with the addition of YUTREPIA even with escalating doses and therefore, likely similar to these patients' historical cough that is associated with their underlying interstitial lung disease.

然而，還應該注意的是，在縱向分析中，平均日間簡化咳嗽評分從基線到第 16 週基本保持不變，這表明咳嗽總體上傾向於短暫性，並且即使增加劑量也不會因添加 YUTREPIA 而惡化，因此，可能與這些患者與其潛在間質性肺病相關的歷史性咳嗽相似。

This tolerability is helping patients escalate to higher doses. The median dose at week eight was 132.5 micrograms or approximately 15 breath equivalents to TYVASO and 159 micrograms at week 16, approximately 18 breath equivalents to TYVASO with the highest exposure of 318 micrograms comparable to approximately 36 breaths 4 times per day of TYVASO nebulizer.

這種耐受性有助於患者增加劑量。第八週的中位數劑量為132.5微克或約15次呼吸當量TYVASO，第16週的中位數劑量為159微克，約18次呼吸當量TYVASO，最高暴露量為318微克，相當於每天4次使用TYVASO霧化器約36次呼吸。

The net result of greater tolerability and higher achieved doses also correlates with a robust efficacy result with the observed median improvements in 6-minute walk distance of 21.5 meters at week 8 that increased further to 31.5 meters at week 16.

更高的耐受性和更高的劑量的淨結果也與強勁的療效結果相關，觀察到第 8 週 6 分鐘步行距離的中位數改善為 21.5 米，第 16 週進一步增加到 31.5 米。

Overall, this data set continues to highlight the robust tolerability, titratability, efficacy and durability of YUTREPIA in a real-world population of PH-ILD patients. We look forward to sharing the detailed data with the medical community targeting the PH Professional Network Symposium Conference in mid-September and a major respiratory conference in October.

總體而言，該數據集繼續強調了 YUTREPIA 在現實世界的 PH-ILD 患者群體中的強大耐受性、可滴定性、有效性和持久性。我們期待在 9 月中旬的 PH 專業網路研討會和 10 月的大型呼吸會議上與醫學界分享詳細數據。

Now I will pass the call to Mike, who continues to guide the company with a firm hand on the financials and with an eye towards supporting continued growth.

現在我將把電話轉給麥克，他將繼續指導公司，嚴格控制財務狀況，並專注於支持持續成長。

Thank you, Roger, and good morning, everyone. In order to save time for more of your questions, I'd just like to hit the headlines on the financial statements filed this morning with the SEC and in our press release. We closed the quarter with over $173 million in cash and cash equivalents on the balance sheet, a solid position that will help us bridge to profitability over the coming quarters as we continue the commercial rollout of YUTREPIA, invest in our pipeline and expand operational capabilities.

謝謝你，羅傑，大家早安。為了節省時間回答大家的更多問題，我只想簡單介紹一下今天早上提交給美國證券交易委員會的財務報表以及我們的新聞稿。本季結束時，我們的資產負債表上有超過 1.73 億美元的現金和現金等價物，這一穩固的地位將幫助我們在未來幾季實現盈利，因為我們將繼續進行 YUTREPIA 的商業推廣、投資我們的管道並擴大營運能力。

On the revenue side, we generated $8.8 million in the second quarter, of which $6.5 million came from YUTREPIA product sales, which began shipping in June. The additional $2.3 million in service revenue related to our ongoing promotion agreement of treprostinil injection with Sandoz. Expenses for the quarter were in line with our expectations as we fully transitioned into commercialization mode.

在收入方面，我們在第二季創造了 880 萬美元的收入，其中 650 萬美元來自 YUTREPIA 產品銷售，該產品於 6 月開始出貨。額外的 230 萬美元服務收入與我們與 Sandoz 正在進行的曲前列尼爾注射劑推廣協議有關。由於我們已完全過渡到商業化模式，本季的支出符合我們的預期。

Looking forward to the end of the year, we anticipate increases in quarterly R&D expenses as we continue ongoing label studies and prepare to initiate the pivotal study of L606. SG&A expenses after excluding noncash and variable costs associated with YUTREPIA sales should remain flat over the next few quarters.

展望年底，隨著我們繼續進行標籤研究並準備啟動 L606 的關鍵研究，我們預計季度研發費用將會增加。扣除與 YUTREPIA 銷售相關的非現金和變動成本後的銷售、一般及行政費用 (SG&A) 在未來幾季內應會保持穩定。

Our planned commercial spending supports the launch. But that said, any increase would be targeted to further acceleration in YUTREPIA adoption.

我們的計劃商業支出將支持此次發布。但話雖如此，任何增加都是為了進一步加速 YUTREPIA 的採用。

Lastly, with YUTREPIA approved, we are expanding our footprint in North Carolina and have signed a lease for additional manufacturing space to support continuing growth, potentially tripling our production capacity. Targeted for occupancy in 2026, this state-of-the-art facility will include production space to house additional print manufacturing lines and analytical labs to support additional YUTREPIA manufacturing. We are continuing to execute on our plan and our cash position gives us the flexibility to keep moving forward with confidence.

最後，隨著 YUTREPIA 的批准，我們正在擴大在北卡羅來納州的業務範圍，並簽署了額外製造空間的租約，以支持持續增長，有可能使我們的生產能力提高三倍。這個最先進的設施計劃於 2026 年投入使用，將包括生產空間以容納額外的印刷生產線和分析實驗室，以支援額外的 YUTREPIA 製造。我們正在繼續執行我們的計劃，我們的現金狀況使我們有足夠的靈活性和信心繼續前進。

With that, I'll hand it back to Roger.

說完這些，我就把它交還給羅傑。

Thanks, Mike. In just over two months, YUTREPIA has delivered on every front with brand awareness growing, prescriptions rapidly escalating, payer access expanding and clinical data maturing. With a clear and differentiated product profile, we are building a foundation, not just for a successful launch, but for long-term leadership in the prostacyclin market. I would like to thank our entire team who, like our product, are best-in-class. One final note before we begin the Q&A session.

謝謝，麥克。在短短兩個多月的時間裡，YUTREPIA 在各個方面都取得了成效，品牌知名度不斷提高，處方量迅速增加，付款人訪問權限不斷擴大，臨床數據日趨成熟。憑藉著清晰且差異化的產品配置，我們不僅為成功推出產品奠定了基礎，也為在前列環素市場的長期領導地位奠定了基礎。我要感謝我們整個團隊，他們就像我們的產品一樣，都是一流的。在我們開始問答環節之前還有最後一點要說明。

We plan to host an R&D Day in the fall, where we will provide an update on our open-label L606 study, which will include data for patients who have been on L606 for up to a year. We are as excited about L606 as we are YUTREPIA, but today is YUTREPIA's day in the spotlight. Plus L606 deserves its own stage to properly highlight its own unique product profile. With that, operator, first question, please.

我們計劃在秋季舉辦研發日，屆時我們將提供有關開放標籤 L606 研究的最新信息，其中將包括使用 L606 長達一年的患者的數據。我們對 L606 的興奮程度與對 YUTREPIA 的興奮程度一樣，但今天是 YUTREPIA 備受關注的日子。此外，L606 值得擁有自己的舞台來充分凸顯其獨特的產品形象。接線員，請問第一個問題。

(Operator Instructions)

（操作員指示）

Julian Harrison, BTIG.

朱利安·哈里森（Julian Harrison），BTIG。

Hi, good morning. Congrats on the strong launch. These are very impressive numbers. Three questions from us. First, on a weekly basis, has the YUTREPIA growth generally looked sequential? Or was there some bolus effect early on? Second, PAH versus PH-ILD mix along with percentage of patients diagnosed with underlying IPF, are you able to disclose those numbers now?

嗨，早安。祝賀此次成功發布。這些數字非常令人印象深刻。我們提出三個問題。首先，按週計算，YUTREPIA 的成長總體上看起來是連續的嗎？或者早期是否存在某種推注效應？其次，PAH 與 PH-ILD 混合情況以及被診斷患有潛在 IPF 的患者百分比，您現在能透露這些數字嗎？

And finally, on ASCENT, it was great to see the very strong 6-minute walk data out to or through 16 weeks. I'm curious if you could talk more about your decision to lead with the median six minute walk changes instead of the average. Why are median changes maybe more appropriate here? And how does that compare to the competitive landscape?

最後，在 ASCENT 上，很高興看到長達 16 週的非常強勁的 6 分鐘步行數據。我很好奇，您是否可以詳細談談您決定採用六分鐘步行中位數變化而不是平均值作為主導的決定。為什麼中位數變化在這裡可能更合適？與競爭格局相比如何？

Great, Julian. Thanks for the questions. So in terms of uptake, what we said in the script is that we've had accelerating uptake over time. So as we've been in the market, again, still just for 11 weeks, each week seems to be a little bit better than the one before. And we think that trend hopefully will continue, particularly as we continue to evolve the payer landscape and remove some of the things like new-to-market blocks that existed when you first launched drugs.

太好了，朱利安。感謝您的提問。因此，就吸收而言，我們在劇本中說過，隨著時間的推移，我們的吸收速度不斷加快。因此，當我們再次進入市場時，仍然只有 11 週的時間，每週似乎都比前一周好一點。我們認為這種趨勢有望持續下去，特別是隨著我們繼續改進付款人格局並消除藥品首次上市時存在的一些障礙，例如新藥上市障礙。

So awareness is driving a lot of that. I think we had a focus on the centers of excellence, the key centers. And certainly, the adoption there has been rapid. I think the messages have been resonating very quickly, and that's the result of that as you see that in the referrals and the script rate. We're not going to give the PAH versus PH-ILD split today, we want to make sure if we were to do that, that we had absolute clarity on what that is.

因此，意識在很大程度上推動了這一進程。我認為我們重點關注的是卓越中心和關鍵中心。當然，那裡的採用速度非常快。我認為這些訊息很快就引起了共鳴，這就是您在推薦和腳本率中看到的結果。我們今天不會對 PAH 與 PH-ILD 進行分類，我們希望確保如果我們要這樣做，我們對這是什麼有絕對的清楚的認識。

And just because of the way some of that data has been collected, we can't really confirm exactly and precisely what the therapeutic split would be. And then for the ASCENT trial, maybe I'll hand that over to Rajeev to talk about why we think median data is most appropriate and more reflective.

且由於部分數據的收集方式，我們無法準確、精確地確認治療分配。然後對於 ASCENT 試驗，也許我會把它交給 Rajeev 來談談為什麼我們認為中位數數據最合適且更具反映性。

But the simple answer is, and I'll give it to Rajeev, is that it minimizes the impact of outliers. So particularly in an open-label study, you really want to look at medians to give a more, I think, accurate and reflective result from a population that we've studied.

但簡單的答案是，我會把它告訴 Rajeev，那就是它可以最大限度地減少異常值的影響。因此，特別是在開放標籤研究中，您確實希望查看中位數，以便從我們研究的人群中獲得更準確、更具反映性的結果。

So Rajeev, any other comment on that?

那麼 Rajeev，對此還有其他評論嗎？

Yeah, Roger. Julian, nice to hear from you. No, I completely agree. I think it's less susceptible to being skewed to outliers or extreme values. It's important to provide the central tendency in these situations, especially with small samples.

是的，羅傑。朱利安，很高興收到你的來信。不，我完全同意。我認為它不太容易受到異常值或極端值的影響。在這些情況下，提供集中趨勢非常重要，尤其是對於小樣本。

And I think it also is more akin to how larger data sets are usually conveyed. I will state that we will be showing more granular detail at the upcoming conference at PHPN and in the upcoming conference in October. But I think we can say with a high degree of confidence with a high degree of certainty that the mean and median values are fairly near each other. So I think that's really important to note as well.

我認為它也更類似於通常傳達較大數據集的方式。我要說的是，我們將在即將舉行的 PHPN 會議和十月即將召開的會議上展示更詳細的資訊。但我認為我們可以非常有信心、非常肯定地說平均值和中位數相當接近。所以我認為這也非常重要。

Very helpful all around. Congrats again.

非常有幫助。再次恭喜。

Thank you, Julian. Always good to hear from you. Operator, next question, please.

謝謝你，朱利安。很高興收到您的來信。接線員，請問下一個問題。

Ryan Deschner, Raymond James.

瑞安‧德施納、雷蒙‧詹姆斯。

Good morning. Congratulations on the strong start to your YUTREPIA launch and the ASCENT results. What proportion of paid drug is associated with the reported patient starts? And is this in line with your expectations? And what proportion of patient starts are switches from TYVASO DPI or other inhaled or oral treprostinil products?

早安.恭喜您的 YUTREPIA 啟動和 ASCENT 成果取得良好開端。付費藥品的比例與報告的病人開始服用藥物有關嗎？這符合您的預期嗎？有多少比例的患者是從 TYVASO DPI 或其他吸入或口服曲前列尼爾產品轉換而來的？

Yeah, So let me, Mike, if you wouldn't mind answering the paid drug question and Scott, our Chief Commercial Officer, you can talk about proportions as you can.

是的，所以，麥克，如果你不介意回答付費藥物的問題，以及我們的商務長史考特，你可以盡可能地談論比例。

Yeah, Thanks, Roger. And Ryan, great to talk to you. In terms of proportion of paid versus new start -- I'm sorry, as free drug. As we -- as everyone knows, we have a couple of programs.

是的，謝謝，羅傑。Ryan，很高興與您交談。就付費與新開始的比例而言——對不起，就像免費藥物一樣。眾所周知，我們有幾個項目。

We have a voucher program that provides the first 28 days free drug for new patients. Then we also have a bridge program that provides an additional 28-day supply at any time during -- one time during a patient's journey. So what I would say is specifically the amount of paid versus free drug, especially through the usage of the voucher program, it's in line with our expectations of what we've seen in other launches.

我們有一個優惠券計劃，為新患者提供前 28 天的免費藥物。然後，我們還有一個過渡計劃，可以在患者治療期間的任何時間（一次）提供額外的 28 天供應。因此，我想說的是，特別是透過使用代金券計劃，付費藥品與免費藥品的數量是一致的，這符合我們對其他產品發布情況的預期。

Less than 50% have been on free voucher drugs, but again, we wanted to make sure we gave patients an opportunity to try our drug immediately to see if it's something that works for them and allows us to start that insurance adjudication process as we go. But we're very happy with the services that we provide, the market access services, specifically that Scott and his team have provided, and I think have been very helpful for us as we've gotten YUTREPIA off the ground.

不到 50% 的患者使用了免費代金券藥物，但我們再次希望確保患者有機會立即嘗試我們的藥物，看看它是否適合他們，並允許我們啟動保險裁決程序。但是我們對所提供的服務感到非常滿意，市場准入服務，特別是斯科特和他的團隊所提供的服務，我認為這些服務在我們啟動 YUTREPIA 的過程中提供了很大的幫助。

Great, and Scott, if you'll handle the second question.

太好了，斯科特，請你回答第二個問題。

Sure. So in terms of switches versus new to prostacyclin patients, I think we've said in the past that our primary focus is the new to prostacyclin patients. And to commensurate with that, we've preponderance of the patients that are coming in. We have seen switches. I think it's no secret that there are many patients out there who've been on a DPI or nebulized inhaled and are either on that and are dissatisfied or came off of it.

當然。因此，就轉換治療方案與新接受前列環素治療的患者而言，我想我們過去曾說過，我們的主要關注點是新接受前列環素治療的患者。與此相應的是，我們接收了大量的患者。我們已經看到了開關。我認為這不是什麼秘密，很多患者都使用過 DPI 或霧化吸入療法，他們要么對治療不滿意，要么就停止使用。

And so I think as Roger said in the prepared remarks, we have been surprised, let's say, with the volume of those. We're not going to get into the exact numbers. And we are also seeing, as I think Roger mentioned, some oral prostacyclin switches as well.

因此，我認為，正如羅傑在準備好的發言中所說的那樣，我們對這些數量感到驚訝。我們不會透露確切的數字。而且，正如羅傑所提到的，我們也看到一些口服前列環素的轉換。

So we'll keep an eye on that as time goes along and get a feel for what the run rate is for that, but that's kind of how it's playing out currently.

因此，隨著時間的推移，我們會密切關注這一點，並了解其運行率，但這就是目前的情況。

Thanks, Scott. I think the only thing I would add to that is where we said we -- even I was surprised by the upside here, I think it was because of these switches. What we found is that there is a large number of patients with intolerant cough who remain on TYVASO DPI, but are parked at low dose, so aren't really getting the benefit of the prostacyclin that they deserve and those patients have readily looked forward to receiving YUTREPIA. So that's been where the incremental upside has been in this near term.

謝謝，斯科特。我認為我唯一要補充的是，我們說過——即使我對這裡的優勢感到驚訝，我認為這是因為這些轉變。我們發現，有大量患有不耐受咳嗽的患者仍在服用 TYVASO DPI，但劑量較低，因此並沒有真正獲得他們應得的前列環素益處，而這些患者已經迫不及待地期待接受 YUTREPIA 治療。這就是近期增量上漲的所在。

And I think that will continue to grow, particularly as the experience in the new patient arena sort of shows prescribers and patients that this drug is very, very effective and it's the therapeutic protege that we hoped it would be. Next question, please?

我認為這種趨勢將會繼續增長，特別是當新患者領域的經驗向處方醫生和患者表明這種藥物非常非常有效，並且它是我們所希望的治療藥物時。請問下一個問題？

Jason Gerberry from Bank of America.

美國銀行的 Jason Gerberry。

Hey, good morning guys, and congratulations on the launch as well. My question, just thinking about second half in these patients that have started on YUTREPIA, how should we think about sort of the gross to net? Presumably, they've already kind of gone through their 28-day voucher.

嘿，大家早上好，也祝賀發布會圓滿成功。我的問題是，僅考慮開始使用 YUTREPIA 的這些患者的後半部分，我們應該如何考慮總額與淨額的關係？據推測，他們已經用完了 28 天的優惠券。

And so I'm just kind of curious like if that -- those patients are going to flow through at full WAC or if there's a gross to net assumption that we should assume for those patients plus those that maybe convert from the prescription referral to a start.

所以我只是有點好奇，這些病人是否會以全額 WAC 流過，或者我們是否應該對這些病人以及那些可能從處方轉診轉換為開始的病人進行總額到淨額的假設。

And that 75% conversion rate, the other 25% that haven't converted, is that just a function of time? Or is there anything structural or gating for those patients? Just trying to get a sense of what that process is like and the typical time from starting the prior authorization process to ensuring coverage?

而那 75% 的轉化率，還有另外 25% 尚未轉化，這只是時間的函數嗎？或者對於這些患者來說是否有任何結構性或門控性因素？只是想了解這個過程是怎樣的，以及從開始事先授權過程到確保覆蓋的典型時間是多少？

Great. Thank you, Jason. Great questions. Mike, if you wouldn't mind answering those questions. You might be on mute.

偉大的。謝謝你，傑森。很好的問題。麥克，如果你不介意回答這些問題的話。您可能處於靜音狀態。

Sorry. As it relates to gross to net, it's not something that we've talked about in terms of projecting what our gross to nets to be. I mean, I think what we've said all along is from a payer point of view, we want to make sure patients have an opportunity to choose YUTREPIA.

對不起。因為它與毛利與淨利的比率有關，所以我們在預測毛利與淨利的比率時並沒有討論過這個問題。我的意思是，我認為我們一直以來所說的是從付款人的角度來看，我們希望確保患者有機會選擇 YUTREPIA。

As Roger said earlier, there have been new to market blocks, especially in areas where our competitor has contracted specifically in the commercial space. We now have signed contracts with all of the major commercial payers.

正如羅傑之前所說，市場上出現了新的區塊，特別是在我們的競爭對手在商業領域專門簽約的地區。我們現在已經與所有主要商業付款人簽訂了合約。

We expect those new-to-market blocks to be removed shortly. So we would expect, like I said, more prescriptions as we move through the year to be subject to rebates. But again, we're very confident in our ability for YUTREPIA to win in this space. very confident for us to be at parity access. And our stated goal from the very beginning was that we would -- we want to make sure patients have a choice.

我們預計這些新進入市場的障礙將很快被消除。因此，正如我所說，我們預計，隨著時間的推移，會有更多的處方藥享受回扣。但是，我們非常有信心，我們有能力讓 YUTREPIA 在這一領域獲勝。我們非常有信心，我們能夠獲得同等的存取權限。我們從一開始就明確的目標是－我們希望確保患者有選擇權。

And I think Scott and his team have done a great job of working towards that, and we look forward to further development there here in the second half of the year. The second question around the convert rate. What I would say is, again, the patient support services that we put in place, which includes reimbursement specialists to navigate this landscape.

我認為史考特和他的團隊為此做出了巨大努力，我們期待今年下半年會進一步發展。第二個問題是關於轉換率。我想再次強調的是，我們已建立起病患支援服務，其中包括負責解決此問題的報銷專家。

We expect -- when you look at industry standards, I think that's a very, very good percentage. Again, as Roger said, there were some headwinds early on as it relates to these new-to-market blocks as those release, we think that, that could be an accelerant as we get through the back end of the year here and as we move forward, again, to make sure patients have the ability to choose, and we feel very confident in our ability to deliver on that.

我們預計——當你查看行業標準時，我認為這是一個非常非常好的百分比。再次，正如羅傑所說，早期與這些新上市區塊相關的一些阻力，因為這些區塊的發布，我們認為，這可能會成為我們度過今年年底的加速器，隨著我們繼續前進，再次確保患者有能力選擇，我們對實現這一目標的能力非常有信心。

And Mike, if I could just squeeze a follow-up in. Just any commentary regarding Symphony data on a go-forward basis? Should we look at it? Have you guys interrogated that? And how we should interpret that on a go-forward basis?

麥克，如果我能擠出時間跟進的話。您對於 Symphony 資料的未來發展有何評論？我們應該看一下嗎？你們有詢問過這個問題嗎？我們該如何從未來角度解讀這一點？

Yeah, so what I would say is, as is pretty standard in the industry, this information is usually not available. We obviously have seen the data like you have. I would not expect to see future data to come out, and we look forward to sharing our results as we go through each quarterly earnings call.

是的，所以我想說的是，正如行業標準一樣，這些資訊通常是無法獲得的。我們顯然已經像您一樣看到了這些數據。我不會期望看到未來的數據出來，我們期待在每個季度收益電話會議中分享我們的結果。

Thanks.

謝謝。

Cory Jubinville, LifeSci Capital.

Cory Jubinville，LifeSci Capital。

Good morning and congrats on all the progress. It seems like traction has been really great so far. As we think about launch plans throughout the rest of the year, what kind of near-term levers are there to pull to accelerate growth?

早上好，恭喜你取得的所有進展。到目前為止，看起來牽引力確實很大。當我們考慮今年剩餘時間的發布計畫時，有哪些短期槓桿可以推動成長？

And again, given the traction you've seen so far is the plan -- or is the plan to kind of largely stay on course versus pull some of these levers? And you also mentioned that you've signed contracts with the three major commercial players. When do those contracts kick in and you start to get reimbursement through that?

再說一次，鑑於您目前所看到的進展，該計劃是——還是基本上保持原有的計劃，而不是採取一些措施？您也提到，您已經與三大商業公司簽訂了合約。這些合約什麼時候生效並且您開始透過合約獲得報銷？

Yeah, thanks for the question, Cory. So what we -- I'll take the second question first, and then, Scott, if you'll comment on the launch plans and levers that we could pull going forward. But I guess we're going to stick to the script that like in the coming quarters, we think the payer landscape will improve. And so that's going to be in place to happen and be an accelerant, as we've said.

是的，謝謝你的提問，科里。那麼我們——我先回答第二個問題，然後，史考特，你能否評論一下我們未來可以採取的啟動計畫和手段。但我想我們會堅持這樣的腳本，就像在接下來的幾個季度裡，我們認為付款人的狀況將會改善。正如我們所說的那樣，這將會發生並成為一種加速劑。

And Scott, maybe you can talk about the levers that could be pulled going forward in terms of launch.

斯科特，也許你可以談談在發布方面可以採取哪些措施。

Yeah, sure. So the first thing I'd point out is that I think we have immense opportunity, both from a breadth and for a depth standpoint to capitalize on. So to take, for example, the amount of breadth, I think we said 350 prescribers have prescribed thus far, but we've also said in the past that we have 6,500 targets across the country. So there's well over 6,000 out there who have not had the opportunity to use YUTREPIA and from a breadth standpoint, we're just getting started.

是的，當然。因此，我想指出的第一件事是，我認為無論從廣度還是深度的角度來看，我們都擁有巨大的機會。以廣度為例，我想我們說過，到目前為止已經有 350 名開處方者開出了處方，但我們過去也說過，我們在全國有 6,500 個目標。因此，有超過 6,000 人還沒有機會使用 YUTREPIA，從廣度的角度來看，我們才剛起步。

I mean we've been pleased to have physicians with one, two, three, four, five plus patients, but many more of them can have that depth and will have that depth. From an activity sort of lever standpoint, I think one is just fuel the fire. We're going to continue to work with the centers identify on YUTREPIA.

我的意思是，我們很高興有一位醫生可以治療一到五位以上的病人，但更多的醫生可以有這樣的深度，並且將會有這樣的深度。從活動槓桿的角度來看，我認為其中一個只是火上加油。我們將繼續與 YUTREPIA 中心合作。

We have had community physicians for sure that have prescribed, but we will now start to kind of work our way back out into the community to get PAH patients, but also to start to get PH-ILD patients. And then strictly from a tactical perspective, I mean, we'll be at all the major conferences.

我們確實有社區醫生開處方，但現在我們將開始回到社區，接收 PAH 患者，同時也開始接收 PH-ILD 患者。然後嚴格從戰術角度來看，我的意思是，我們會參加所有主要的會議。

We'll be loud from an electronic standpoint. We still have a full suite of launch marketing that's going on right now and will certainly continue to go on for the rest of the year.

從電子角度來說，我們會很大聲。我們現在仍在進行全套的發布行銷活動，並且肯定會在今年剩餘時間繼續進行。

And Scott, maybe I'll add in terms of like I think all of those activities are clearly going to be beneficial to the brand. I think in terms of the levers, I can think of five just off the top of my head is like, as Scott said, continue to increase breadth and depth of prescribers, especially as we go out into the community centers more because I think in this initial phase, we were somewhat focused on the major centers.

斯科特，也許我應該補充一點，我認為所有這些活動顯然都會對品牌有益。我認為就槓桿而言，我能想到的五個槓桿就是，正如斯科特所說的那樣，繼續增加處方者的廣度和深度，特別是當我們更多地走進社區中心時，因為我認為在這個初始階段，我們有點專注於主要的中心。

As we've said, we'll get acceleration from payer engagement and coverage. The third would be that now that there's traction and switch opportunity, maybe try to leverage that more broadly and talk about that experience more widely with prescribers so that they too can benefit from the transition with their patients.

正如我們所說，我們將從付款人的參與和覆蓋中獲得加速。第三，既然現在有了牽引力和轉變機會，也許可以嘗試更廣泛地利用這一點，並與處方醫生更廣泛地討論這種經驗，以便他們也可以從患者的轉變中受益。

I think the fourth lever would be to focus on YUTREPIA's dosing flexibility to drive durability. I think it's just as important as starting patients is keeping patients on therapy, and that's obviously going to be a key focus for our commercial enterprise going forward.

我認為第四個槓桿是專注於 YUTREPIA 的劑量靈活性以提高耐用性。我認為讓患者繼續接受治療與開始治療同樣重要，這顯然將成為我們商業企業未來發展的重點。

And then I think we should also now begin to capture this initial data from oral transitions, particularly as they come off UPTRAVI is what we've seen early and begin to focus potentially on an initiative to support that in terms of how to inform doctors how to do that. So lots of levers that we can pull all will drive future business. So I think this is a very levered business in terms of what we can accomplish going forward.

然後我認為我們現在也應該開始從口腔轉變中獲取初始數據，特別是因為它們來自 UPTRAVI，這是我們早期看到的，並開始潛在地關註一項支持該舉措的計劃，即如何告知醫生如何做到這一點。因此，我們可以採取多種手段來推動未來的業務。因此，我認為，就我們未來能夠取得的成就而言，這是一項非常有槓桿作用的業務。

Serge Belanger, Needham.

塞爾日·貝朗格，尼德漢姆。

Hi, good morning and congrats on a great start. Had some technical difficulties this morning. So apologies if you've covered this already. So first of all, on the $6.5 million, can you give us a split between channel inventory and patient demand. Secondly, regarding payer coverage, can you tell us where you're currently at and where you expect to be by the next quarter? And is the coverage similar to Tyvaso.

嗨，早安，恭喜你有個美好的開始。今天早上遇到了一些技術問題。如果您已經討論過這個問題，請見諒。那麼首先，關於 650 萬美元，您能否將通路庫存和病患需求進行劃分？其次，關於付款人涵蓋範圍，您能否告訴我們您目前的狀況以及預計下個季度的狀況？其覆蓋範圍與 Tyvaso 相似。

I have another follow-up, but I'll start there.

我還有其他後續事宜，但我將從那裡開始。

Thank you, Serge. Mike, can you answer those questions, please?

謝謝你，塞爾吉。麥克，你能回答這些問題嗎？

Yeah, Serge, thanks for your question. Specifically on the breakdown on revenue, I'd say, especially for first quarter of launch, the vast, vast majority of that revenue was load in the channel. As you can imagine, as we previously talked about, we put product into the channel the first week of June. We dosed our first patient shortly thereafter. But just from a pure timing point of view, there would be a lot of that initial revenue would be loading the channel.

是的，Serge，謝謝你的提問。具體到收入細目，我想說，特別是發布後的第一季度，絕大部分收入都來自通路收入。正如您所想像的，正如我們之前所討論的，我們在六月的第一周將產品投入渠道。此後不久，我們給第一位病人注射了藥物。但僅從純粹的時間角度來看，最初的收入很大一部分將來自通路。

With that being said, obviously, with the accelerating patient numbers that we've seen, we start seeing stacking of patients as we move into second scripts. The vast majority of that has already been absorbed as we move into Q3.

話雖如此，顯然，隨著我們看到患者數量的增加，當我們進入第二個處方時，我們開始看到患者人數的累積。隨著我們進入第三季度，其中絕大部分已經被吸收。

Related to payer coverage, again, like we've always said, we want to make sure that patients have choice in order for patients to have choice, we need to make sure they have access to YUTREPIA. As I said earlier, we signed contracts with three major commercial payers. And as those NDC blocks are removed, we feel very confident, as we said, the product profile of YUTREPIA to win and to be the prostacyclin of first choice, as Roger has stated.

關於付款人承保，就像我們一直說的那樣，我們希望確保患者有選擇權，為了讓患者有選擇權，我們需要確保他們能夠獲得 YUTREPIA。正如我之前所說，我們與三大商業付款人簽訂了合約。隨著這些 NDC 區塊被移除，我們感到非常有信心，正如我們所說的，YUTREPIA 的產品特性將獲勝並成為首選的前列環素，正如羅傑所說的那樣。

Being in a parity situation with United Therapeutics, where we are not disadvantaged. And as those kick in, we feel very confident that, that will be the place that we land and feel very confident in our ability to grow.

我們與 United Therapeutics 處於同等地位，並不處於劣勢。隨著這些因素的發揮作用，我們非常有信心，那將是我們落腳的地方，我們對我們的成長能力非常有信心。

And maybe one for Rusty. Just an update on the 327 patent litigation. I think there was a hearing a few weeks ago. I guess when you expect potential decision and what the potential outcomes could be?

也許還有一個給 Rusty。這只是 327 項專利訴訟的最新消息。我認為幾週前舉行過一次聽證會。我猜您何時預期潛在的決策以及潛在的結果會是什麼？

Yeah, thanks for the question, Serge. So as you know, trial was held back at the end of June. At this point, all post-trial briefing is complete. The judge set a relatively accelerated post-trial briefing schedule.

是的，謝謝你的提問，Serge。如你所知，審判於六月底被推遲。至此，所有庭審後簡報均已完成。法官設定了相對較快的審判後簡報時間表。

So post-trial briefing is now complete. As far as when we get a decision, it's always hard to predict how quickly courts are going to roll on things. I think in the first Hatch-Waxman trial in front of Judge Andrews, it was about 2.5 months between the completion of post-trial briefing and his decision.

審判後簡報現已完成。當我們做出判決時，總是很難預測法院將以多快的速度處理案件。我認為，在安德魯斯法官面前審理的第一次哈奇-瓦克斯曼案中，從審後簡報完成到法官作出裁決大約間隔了 2.5 個月。

Obviously, here, he said an accelerated timeline for the post-trial briefing that could indicate that his decision will similarly be a little bit faster than the last time, but again, hard to predict with any degree of precision. And then finally, as to the potential outcomes, it's the same outcomes we've been talking about all along.

顯然，他在這裡表示，審判後簡報的時間表加快了，這可能表明他的決定將比上次更快一些，但同樣，很難以任何精確度進行預測。最後，至於可能的結果，它與我們一直在談論的結果相同。

Again, as with prior litigations, we won't probabilitize what the outcome is going to be or try to get in front of the judge and guess how he's going to rule. But it's sort of the full range of at least potential outcomes consistent with any Hatch-Waxman litigation.

再一次，與先前的訴訟一樣，我們不會推測結果會是什麼，也不會試圖站在法官面前猜測他將如何裁決。但它至少是與任何 Hatch-Waxman 訴訟一致的潛在結果的全部範圍。

(Operator Instructions)

（操作員指示）

Tiago Fauth, Wells Fargo.

富國銀行的蒂亞戈·福斯 (Tiago Fauth)。

Thank you. Let me just add my congratulations as well. A quick one for me. Just thinking about United [patent] studies read-through, kind of what are some of the implications potentially going forward, some debate on orphan drug exclusivity. Any implications for YUTREPIA or for the development path for 606, basically, how you guys are thinking about that if that trial reads out positively?

謝謝。我也謹向你表示祝賀。對我來說很快。只是思考聯合[專利]研究的閱讀，它對未來可能產生的一些影響，以及關於孤兒藥專營權的一些爭論。這對 YUTREPIA 或 606 的發展道路有何影響？基本上，如果試驗結果呈現正面趨勢，你們會怎麼想？

Thanks, Tiago. I'll take that. So I think they've said they're expecting that result in September. So there's really no sense in me trying to predict what that trial result will or won't be. I think if they are successful, they will have some orphan protection for that for a period of time.

謝謝，蒂亞戈。我會接受的。所以我認為他們已經表示他們預計 9 月會得到結果。所以我試著預測試驗結果會是什麼或不會是什麼真的毫無意義。我認為，如果他們成功了，他們將在一段時間內獲得一些孤兒保護。

So I think for us, it would be a matter of developing L606 for that indication so that once that orphan exclusivity expired that we could benefit from that market too, if they are to be successful. But we'll soon see where that lands.

因此我認為，對我們來說，這將是針對該適應症開發 L606 的問題，以便一旦孤兒藥專營權到期，如果他們能夠成功，我們也可以從該市場中受益。但我們很快就會看到結果。

(Operator Instructions)

（操作員指示）

There are no further questions for today. I would now like to hand the conference over to Roger Jeffs for any closing remarks.

今天沒有其他問題了。現在我想將會議交給羅傑·傑夫斯並請他作結語。

Thank you, everyone, for joining today's call. We appreciate your enthusiasm for this initial phase of launch. We remain laser-focused on the execution in the back half of the year and look forward to driving continued uptake, expanding payer access and laying the groundwork for our broader pipeline. And we look forward to speaking with you very, very soon, especially in the fall when we have our R&D Day for L606. Thank you again.

感謝大家參加今天的電話會議。我們感謝您對發布初始階段的熱情。我們將繼續專注於下半年的執行，並期待推動持續的成長、擴大付款人的管道並為我們更廣泛的管道奠定基礎。我們期待很快與您交談，特別是在秋季我們舉辦 L606 研發日的時候。再次感謝您。

This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.

今天的電話會議到此結束。感謝您的參與。你們現在都可以斷開連結了。祝你今天過得愉快。