Liquidia Corporation (LQDA) 2025 Q4 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good morning and welcome to the Liquidia Corporation full year 2025, financial results and corporate update conference call. My name is Josh and I will be your operator today. (Operator Instructions). Please note that today's call is being recorded. I'll now turn the call over to Jason Adair, Chief Business Officer.

    早安,歡迎參加 Liquidia 公司 2025 年全年財務表現及公司最新動態電話會議。我叫喬什,今天將由我為您接聽電話。(操作說明)請注意,今天的通話將會被錄音。現在我將把電話交給首席商務官傑森·阿代爾。

  • Jason Adair - Chief Business Officer

    Jason Adair - Chief Business Officer

  • Thank you, and good morning, everyone. It's my pleasure to welcome you to our full year 2025 financial results and corporate update call. Joining me today are Dr. Roger Jeffs, Chief Executive Officer; Michael Kaseta, Chief Operating Officer and Chief Financial Officer; Dr. Rajeev Saggar, Chief Medical Officer; Scott Moomaw, Chief Commercial Officer; and Rusty Shundler, our General Counsel.

    謝謝大家,大家早安。歡迎各位參加我們2025年全年財務業績及公司最新動態電話會議。今天與我一同出席的有:執行長羅傑·傑夫斯博士;首席營運官兼首席財務官邁克爾·卡塞塔;首席醫療官拉吉夫·薩加爾博士;首席商務官斯科特·穆馬;以及總法律顧問拉斯蒂·舒德勒。

  • Before we begin, please note that today's discussion will include forward-looking statements, including statements regarding future results, product performance and ongoing clinical or commercial activities. These statements are subject to risks and uncertainties that may cause actual results to differ materially. For further information, please refer to our filings with the SEC available on our website.

    在開始之前,請注意,今天的討論將包含前瞻性陳述,包括有關未來業績、產品性能和正在進行的臨床或商業活動的陳述。這些聲明存在風險和不確定性,可能導致實際結果與聲明內容有重大差異。如需了解更多信息,請參閱我們網站上向美國證券交易委員會提交的文件。

  • Please also note that our earnings release and our commentary include non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures can be found in our earnings release. With that, I'll turn the call over to Roger. Roger?

    另請注意,我們的獲利報告和評論中包含非GAAP財務指標。這些非GAAP財務指標與最可比較的GAAP指標的調節表可在我們的獲利報告中找到。接下來,我會把電話交給羅傑。羅傑?

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Thanks, Jason, and good morning, everyone. As we look back on 2025, and forward into 2026, what stands out is the rapid establishment of our preferred product profile paired with precise execution. Last year demonstrated that Liquidia could launch, scale and reach profitability quickly within only 120 days of launch, in fact.

    謝謝傑森,大家早安。回顧 2025 年,展望 2026 年,最突出的是我們迅速建立了首選產品組合,並實現了精準執行。事實上,去年的業績表明,Liquidia 能夠在短短 120 天內迅速啟動、擴大規模並實現盈利。

  • Most importantly, we demonstrated that physicians were willing to rapidly change prescribing behavior when presented with a new differentiated option in YUTREPIA. The benefits of its product profile, deep-lung delivery, low-effort device and wide dose range are taking hold in clinical practice and help place YUTREPIA as one of the top specialty drug launches over the past five years across all therapeutic categories.

    最重要的是,我們證明,當醫生面對 YUTREPIA 這種新的差異化選擇時,他們願意迅速改變處方行為。YUTREPIA 的產品特性、深肺給藥、低操作性裝置和寬劑量範圍等優勢正在臨床實踐中得到認可,並幫助其成為過去五年所有治療類別中頂級專科藥物上市產品之一。

  • This did not happen by chance, but with purpose as a category defining the sense study data clearly set a new data-driven standard for therapeutic success. The momentum of 2025 has clearly carried into 2026.

    這並非偶然,而是以目的為類別來定義意義研究數據,從而為治療成功設定了新的數據驅動標準。2025年的發展動能顯然延續到了2026年。

  • As of February 28, we have received more than 3,600 unique patient referrals and shipped therapy for more than 2,900 patients since launch, maintaining our robust trajectory.

    截至 2 月 28 日,自推出以來,我們已收到超過 3600 例獨特的患者轉診,並為超過 2900 名患者提供了治療,保持了強勁的增長勢頭。

  • While others have observed stagnation from supposed seasonality, that has not been our initial experience as we continue on the same tour trajectory without decline which would suggest that our percent market share is rising and that we are capturing a disproportionate number of new patient starts for inhaled prostacyclins as the best-in-class option.

    雖然其他人觀察到由於所謂的季節性因素導致的停滯,但這並非我們最初的經驗,因為我們繼續沿著同樣的巡迴演出軌跡前進,沒有出現下滑,這表明我們的市場份額百分比正在上升,並且我們正在獲得不成比例的吸入式前列環素新患者起始治療,因為它是同類最佳的選擇。

  • This steady forward momentum is being achieved across PAH and PH-ILD, with new patient prescriptions roughly equal now between the two indications.

    PAH 和 PH-ILD 均取得了穩定進展,目前這兩個適應症的新患者處方量大致相等。

  • Patient starts remain at 75% naive to 25% transitions from other prostacyclins. Importantly, breadth and depth are also improving in a measurable way. We have increased total prescribers to around 860 as centers gain confidence and usage expands in the community.

    患者起始治療中,75% 為初治患者,25% 為從其他前列環素類藥物轉換而來。重要的是,廣度和深度也在以可衡量的方式提高。隨著各中心信心增強,以及社區使用範圍擴大,我們的處方醫生總數已增加到約 860 人。

  • A key indicator of that depth is that roughly 25% of physicians have already referred five or more patients which is exactly the pattern you want to see when the therapy evolves in becoming the standard of choice rather than an initial trial. If 2025, started the full commercial phase, 2026, begins the full clinical exploration of what may be possible with YUTREPIA and L606.

    衡量這種深度的一個關鍵指標是,大約 25% 的醫生已經轉診了五名或更多患者,這正是當一種療法發展成為標準療法而不是初始試驗時,你所希望看到的模式。如果 2025 年開始全面商業化階段,那麼 2026 年將開始全面臨床探索 YUTREPIA 和 L606 可能帶來的好處。

  • Our development strategy is built on principles we have understood for a long time with prostacyclin. Exposure drives efficacy, tolerability drives durability and convenience drives compliance. Each of these elements is critical to the totality of therapeutic experience and speaks to the high bar that YUTREPIA has quickly established around safety, efficacy and convenience.

    我們的研發策略建立在我們長期以來對前列環素的理解之上。曝光度決定療效,耐受性決定持久性,便利性決定遵從性。這些要素對於整體治療體驗都至關重要,也體現了 YUTREPIA 在安全性、有效性和便利性方面迅速建立的高標準。

  • This year, we will look to further cement this best-in-class product profile via the initiation of multiple new studies, including studies that will transition patients from oral and inhaled prostacyclin therapies and a study of new combinations like adjunctive studies with sotatercept that we hope will further advance the changing standard of care.

    今年,我們將透過啟動多項新研究來進一步鞏固這一一流產品的地位,包括將患者從口服和吸入前列環素療法過渡到新療法的研究,以及與索他西普等新組合療法的輔助研究,我們希望這些研究能夠進一步推進不斷變化的治療標準。

  • Further, we will work to initiate new studies to support expansion into additional disease areas such as systemic sclerosis-associated Raynaud's phenomenon and PH-COPD, where high unmet addressable need remains.

    此外,我們將努力進行新的研究,以支持擴展到其他疾病領域,例如係統性硬化症相關的雷諾現象和肺動脈高壓-慢性阻塞性肺病,這些領域仍然存在著巨大的未滿足需求。

  • And of course, we will look to move the therapeutic needle even further via the advancement of our next-generation L606 pivotal study with the study initiated in multiple territories and enrollment expected to begin in the following quarters. Importantly, this disciplined expansion of clinical evidence will be funded by cash flow from operations and will help grow the value of the franchise and the company. With that, I will turn it over to Mike.

    當然,我們將透過推進下一代 L606 關鍵性研究,進一步推動治療進展。該研究已在多個地區啟動,預計將在接下來的幾個季度開始招募受試者。重要的是,這種有條不紊地擴展臨床證據將由營運現金流提供資金,並將有助於提升特許經營權和公司的價值。接下來,我將把麥克風交給麥克。

  • Michael Kaseta - Chief Financial Officer

    Michael Kaseta - Chief Financial Officer

  • Thank you, Roger, and good morning, everyone. Our financial results are a direct reflection of two things: sustained patient growth and retention and disciplined execution. Over the last nine months, as the referral and start curves have moved higher so have revenue, margin contribution and cash generation.

    謝謝你,羅傑,大家早安。我們的財務表現直接反映了兩件事:持續的病患成長和留存以及嚴謹的執行。過去九個月,隨著建議量和啟動量曲線的上升,收入、利潤貢獻和現金流也隨之增加。

  • For the full year 2025, YUTREPIA generated $148.3 million in net product sales including $90.1 million in the fourth quarter, representing 74% growth in net product sales over the third quarter, 2025.

    2025 年全年,YUTREPIA 的淨產品銷售額為 1.483 億美元,其中第四季為 9,010 萬美元,比 2025 年第三季的淨產品銷售額成長了 74%。

  • The fourth quarter also marked our second consecutive quarter of increasing profitability with not only non-GAAP adjusted EBITDA of $27.3 million but also $14.6 million of net income.

    第四季也是我們連續第二季獲利能力成長,不僅非GAAP調整後的EBITDA達到2,730萬美元,淨收入也達到1,460萬美元。

  • We ended the year with approximately $190.7 million in cash and cash equivalents, having generated $33 million of positive cash flow in the fourth quarter alone. Liquidia is now operating as a cash-generating growth engine. That is not aspirational, it is visible in the quarterly numbers and on the balance sheet. Roger, back to you.

    截至年底,我們持有約 1.907 億美元的現金及現金等價物,僅在第四季度就產生了 3,300 萬美元的正現金流。Liquidia 目前正作為一家能夠產生現金流的成長引擎運作。這並非空想,而是從季度財務數據和資產負債表中就能看出來的。羅傑,把機會交還給你。

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Thanks, Mike. We're confident in 2026, and the years ahead as we focus on building a durable franchise with increasing patient preference and a clear path towards at least a $1 billion franchise in 2027, with increasing growth in the years beyond. With that, operator, please open the line for questions.

    謝謝你,麥克。我們對 2026 年以及未來幾年充滿信心,我們將專注於打造一個持久的特許經營品牌,不斷提高患者的偏好,並製定明確的計劃,力爭在 2027 年實現至少 10 億美元的特許經營額,並在之後的幾年裡不斷增長。接線員,請開啟提問頻道。

  • Operator

    Operator

  • (Operator Instructions)

    (操作說明)

  • Ryan Deschner, Raymond James.

    Ryan Deschner,Raymond James。

  • Ryan Deschner - Analyst

    Ryan Deschner - Analyst

  • Thanks for the question and congratulations on the impressive continued launch so far for YUTREPIA. Curious, given the greater than 2,900 patients starts you're reporting today, where do you think this puts you in terms of current market share? And how are you thinking about continued growth in the first half of 2026? And then I have a follow-up.

    感謝您的提問,並祝賀 YUTREPIA 目前為止取得了令人印象深刻的持續成功。很好奇,鑑於您今天報告的患者人數超過 2900 人,您認為這在目前的市場份額中處於什麼位置?您如何看待2026年上半年的持續成長?然後我還有一個後續問題。

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Yeah, thanks, Ryan. I appreciate you joining the call this morning. So it's hard to give an accurate percent market share from a patient number standpoint, given the competitor that doesn't disclose their numbers. So what we have done is talked about we've done an analysis based on revenue that maybe, Mike, if you don't mind going through, that speaks to this question.

    謝謝你,瑞恩。感謝您今天上午參加電話會議。因此,考慮到競爭對手不公開其患者數量,很難從患者數量的角度給出準確的市場份額百分比。所以我們已經討論過,我們已經根據收入進行了分析,也許,麥克,如果你不介意的話,這可以回答這個問題。

  • Michael Kaseta - Chief Financial Officer

    Michael Kaseta - Chief Financial Officer

  • Yeah, thanks, Roger, and thanks, Ryan, for the question. So to give everyone an idea, inhaled treprostinil revenue for Q4 was approximately $550 million and as Roger said, despite what our competitors have talked about with seasonality in Q4 in their business and their corresponding decrease in revenue from Q3, that's still an increase of 5% revenue from Q3 of 2025.

    是的,謝謝羅傑,也謝謝瑞恩的提問。為了讓大家有個概念,第四季度吸入曲前列尼爾的收入約為 5.5 億美元,正如 Roger 所說,儘管我們的競爭對手談到了第四季度業務的季節性因素以及他們相應的收入較第三季度有所下降,但這仍然比 2025 年第三季度的收入增長了 5%。

  • The fact that we had an 80% increase in revenue quarter-over-quarter means that we're accounting for more than 100% of market growth in Q4 and again, as Roger have said, that represents a disproportionate share of new patient starts, along with a fair share of switches from Tyvaso.

    我們季度收入環比增長 80%,這意味著我們在第四季度佔市場增長的 100% 以上,而且正如 Roger 所說,這代表了新患者數量的不成比例的份額,以及相當一部分從 Tyvaso 轉用的患者。

  • In terms of what that share is in Q3, we had about from a revenue point of view, 10% of market revenue that increased to 17% in Q4.

    就第三季的市佔率而言,從營收角度來看,我們約佔市場收入的 10%,而第四季這一比例成長至 17%。

  • So we're seeing a significant increase quarter-over-quarter as Roger mentioned, the 2,900 patients starts in just nine months since launch, that is through February 28. So we're seeing that continued momentum that we've seen in Q4 the first two third of Q1 of 2026, and feel very excited and bullish on our ability to continue a successful launch.

    正如羅傑所提到的那樣,我們看到季度環比顯著增長,自推出以來僅九個月,即截至 2 月 28 日,就有 2900 名患者開始接受治療。因此,我們看到了與 2026 年 4 月至 2026 年 1 月前三分之二時期一樣的持續勢頭,我們感到非常興奮,並對我們繼續成功推出產品的能力充滿信心。

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Thanks, Mike, and Ryan, just to add, I don't -- it's been very consistent in terms of trajectory, and we don't see any impediment going forward this year with regard to any change in that trajectory. As we mentioned in the prepared remarks, the depth of prescriptions is increasing.

    謝謝 Mike 和 Ryan,補充一點,我不認為——就發展軌跡而言,它一直非常穩定,而且我們看不到今年在發展軌跡方面有任何阻礙。正如我們在準備好的演講稿中所提到的,處方的深度正在增加。

  • We're working on improving the duration and durability so that scripts back upon scripts so that the revenue growth remains. And I believe you had another question, Ryan?

    我們正在努力提高腳本的持續時間和持久性,以便腳本能夠循環運行,從而保持收入成長。瑞恩,我相信你還有其他問題吧?

  • Ryan Deschner - Analyst

    Ryan Deschner - Analyst

  • Yeah, thanks for that. With the new outcomes data from a competitor that came out recently, what's your take on the potential impact of a new addition to the oral prostacyclin receptor agonist mix on the YUTREPIA launch?

    是啊,謝謝。最近有競爭對手公佈了新的結果數據,您認為口服前列環素受體激動劑組合中新增一種藥物會對 YUTREPIA 的上市產生什麼潛在影響?

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Yeah, I mean it's a good question then. First of all, we'll congratulate therapeutics on a successful trial with a IP1 selective agonist, I think for us, it really doesn't have any impact at all. If you look at it, it's more like UPTRAVI than not. I mean, they're both in the nanomolar range.

    嗯,那確實是個好問題。首先,我們要祝賀 Therapeutics 公司成功完成了 IP1 選擇性激動劑的試驗,但我認為這對我們來說真的沒有任何影響。仔細觀察,它更像是 UPTRAVI 而不是其他類型。我的意思是,它們的濃度都在納摩爾範圍內。

  • I think potency-wise, they're generally similar. Their target binding profile is highly selective just to the IP1 agonist, and I think the results are similar.

    我認為就效力而言,它們總體上是相似的。它們的標靶結合特性對 IP1 激動劑具有高度選擇性,我認為結果類似。

  • You're seeing an effect long term over years in clinical worsening with a very muted effect on symptom oncology which primarily if you look at the six-minute walk distance, which they didn't disclose, they said it was significant. But my guess is it's muted and as you know, with UPTRAVI, they had no statistical significance or clinical significant change in six-minute walk distance.

    從長遠來看,臨床症狀會逐漸惡化,但對腫瘤症狀的影響卻非常微弱。尤其值得注意的是,他們沒有透露的六分鐘步行距離,他們說這很有意義。但我猜測這種影響很小,而且如你所知,使用 UPTRAVI 後,六分鐘步行距離沒有統計意義或臨床意義的變化。

  • In these patients -- when you're talking about a first edition of prostacyclin, the patients are symptomatic and looking for improvement. So I don't think like the oral therapies just aren't going to give that bang for the buck. What they are going to bring is the GI.

    對於這些患者—當您談到第一版前列環素時,患者會出現症狀並尋求改善。所以我認為口服療法並非不划算。他們要帶來的是GI(美國大兵)。

  • And if you look at the AE profile that was shown, you could see a high degree of GI side defects, diarrhea, emesis and nausea. So I think it's more of the same and all the results that Mike just talked about in terms of our launch trajectory and success, are in the presence of UPTRAVI being in the market.

    如果你看一下所顯示的AE概況,你會發現有很高的胃腸道副作用、腹瀉、嘔吐和噁心程度。所以我覺得情況大同小異,Mike剛才提到的所有關於我們產品發表軌跡和成功的結果,都是在UPTRAVI進入市場之後取得的。

  • So it's really to me, it's really an interchange between how that -- how ralinepag will compete with UPTRAVI in the marketplace once it's launched.

    所以對我來說,這實際上是 ralinepag 推出後將如何在市場上與 UPTRAVI 競爭的問題。

  • So not that concerning. I think also if you look at their box and whisker plot, while they did have success across a lot of different subgroups, one thing that was not differentiated was dose.

    所以沒什麼好擔心的。我認為,如果你看他們的箱線圖,雖然他們在許多不同的亞組中都取得了成功,但有一點沒有區分,那就是劑量。

  • So it doesn't seem like there's an ability to dose a better outcome there so what you see is what you get based on probably close to the initial start dose.

    所以似乎無法透過調整劑量來獲得更好的結果,因此你看到的就是基於接近初始起始劑量所得到的結果。

  • So again, more of the same, and I don't think it will be impactful in any way in terms of how we view our business.

    所以,情況依舊如此,我認為這不會對我們如何看待自己的業務產生任何影響。

  • Operator

    Operator

  • Julian Harrison, BTIG.

    Julian Harrison,BTIG。

  • Julian Harrison - Analyst

    Julian Harrison - Analyst

  • Hi, congrats on the progress. Roger, I'm sure you're very familiar with soft mist inhalers, can you help us better understand the differentiation potentially of YUTREPIA, maybe L606 as well relative to a softness inhaler that was recently announced by another company in the space?

    您好,恭喜您有進展。羅傑,我相信你對軟霧吸入器非常熟悉,你能否幫助我們更好地了解 YUTREPIA(或許還有 L606)相對於該領域另一家公司最近發布的軟霧吸入器的潛在區別?

  • And then as a follow-up, regarding the PAH versus PH-ILD split of patients on YUTREPIA, should we still be thinking about that on approximately a 3:1 basis? How do you see that maybe evolving over time.

    那麼,作為後續問題,關於 YUTREPIA 治療中 PAH 與 PH-ILD 患者的劃分,我們是否仍然應該以大約 3:1 的比例考慮呢?您認為這種情況會如何隨時間演變?

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Yeah, I'll answer the and maybe ask Scott to help me with the second question first. So we've moved to a pretty equal split now between PAH and PH-ILD. There's clearly more white space opportunity in PH-ILD. And I think as we -- one of the things we're doing is we're going to grow our sales force significantly by one third.

    好的,我會回答第一個問題,也許會先請Scott幫我解答第二個問題。所以現在 PAH 和 PH-ILD 的比例基本上已經持平了。菲律賓-ILD領域顯然還有更大的發展空間。我認為,我們正在採取的措施之一是將銷售團隊規模大幅擴大三分之一。

  • So we're going to have a larger share of voice. And the purpose of that larger share of voice is to get into the community, particularly into the PH-ILD space to continue to penetrate that market, drive awareness and either drive starts to drive referrals.

    所以我們將擁有更大的話語權。而擴大發聲份額的目的是為了進入社區,特別是進入 PH-ILD 領域,繼續滲透該市場,提高認知度,並最終推動轉診。

  • So I think over time, that should become an increasing value proposition. But in PAH, don't forget, we have not only the inhaled market opportunity, but we're also going after the oral and parenteral opportunity.

    所以我認為隨著時間的推移,這應該會成為一個越來越有價值的主張。但是,在肺動脈高壓領域,不要忘記,我們不僅有吸入劑市場的機會,我們還在爭取口服和注射市場的機會。

  • So on aggregate revenue numbers, they may appear similar in terms of the business opportunity but in pure patient numbers, I think PH-ILD has the opportunity to be more successful. Scott, do you have any other questions or any other responses that you'd like to add?

    因此,從總收入數字來看,它們在商業機會方面可能看起來相似,但就純粹的患者數量而言,我認為 PH-ILD 有更大的成功機會。史考特,你還有其他問題或想補充的答案嗎?

  • Scott Moomaw - Chief Commercial Officer

    Scott Moomaw - Chief Commercial Officer

  • I would completely just agree with everything Roger said. It's been interesting to see PAH get off to a fast start. But as we mentioned, PH-ILD has come on strong and about half where it's going to go from here.

    我完全同意羅傑說的每一句話。PAH 的快速發展令人矚目。但正如我們所提到的,PH-ILD 已經發展得非常迅速,而且已經達到了未來發展趨勢的一半左右。

  • I think PH-ILD, we know PH-ILD is definitely the bigger opportunity long term, as Roger called it the white space but there's still a load of opportunity in PAH. So where it will settle out eventually, I think PH-ILD definitely will be bigger, but there's a lot of growth in both buckets right now to continue in the near term.

    我認為 PH-ILD,我們知道從長遠來看,PH-ILD 絕對是更大的機遇,正如 Roger 所說的空白領域,但 PAH 仍然有很多機會。所以最終結果會如何,我認為 PH-ILD 肯定會更大,但目前這兩個領域都有很大的成長空間,短期內還會繼續成長。

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Yeah. Great. Thanks, Scott. So again, Julian, there's multibillion dollar opportunities in each indication. So we're excited about the opportunity that YUTREPIA and subsequently L606 will have in these markets.

    是的。偉大的。謝謝你,斯科特。所以,朱利安,每個適應症都蘊藏著數十億美元的機會。因此,我們對 YUTREPIA 以及隨後的 L606 在這些市場中的機會感到興奮。

  • With regard to the SMI, I know it's a seminal question for everybody in sort of front of mind because there were some pretty hyperbolic comments made about it.

    關於 SMI,我知道這是一個大家非常關心的重要問題,因為之前有人對此發表了一些非常誇張的評論。

  • What I would say is I think their commentary in general was it sounded very much to me that it was validating YUTREPIA because it sounds like they're trying to develop product that has the product profile of YUTREPIA. So -- and what is that? It's an easy-to-use low-resistance device with high portability. There's mitigation of cough.

    我想說的是,我認為他們的評論總體上聽起來很像是在肯定 YUTREPIA,因為聽起來他們正在努力開發與 YUTREPIA 產品定位相似的產品。所以——那是什麼?它是一款易於使用、阻力小、便攜性高的設備。咳嗽症狀有所緩解。

  • But for us, it's specifically done view of the print formulation of engineered particles in the lower end of the respirable range and then dosing flexibility due to that tolerance which then parlays as we've clearly shown in the ASCENT study that we can rapidly and aggressively dose patients to 2 times or 4 times the past standard with absolutely no exacerbation in cough in a population of PH-ILD patients who have a baseline cough and a high predilection for exacerbation of cough when they take inhalation therapy.

    但對我們來說,這是專門針對可吸入範圍下限的工程顆粒的打印配方進行的,然後由於這種耐受性而實現的劑量靈活性,正如我們在 ASCENT 研究中清楚地表明的那樣,我們可以快速、積極地將患者的劑量提高到過去標準的 2 倍或 4 倍,而絕對不會加劇基線咳嗽且在接受吸入性治療時咳嗽且在接受吸入性治療時的 PH-ILD 患者群體。

  • So YUTREPIA is putting an ideal product profile. What Mike described is we're clearly getting the lot, if not most, of the NRx share, and our TRx share is catching up over time. And the SMI to me is just -- it's a repurposed opportunity.

    所以 YUTREPIA 正在打造理想的產品形象。麥克描述的意思是,我們顯然獲得了大部分(如果不是全部)NRx 份額,而且我們的 TRx 份額正在逐步趕上。對我來說,SMI 只是一個重新利用的機會。

  • So if you go back to the 793 patent that has a priority date of 2006, and look at example one in particular, it talks about there a single-dose acute administration of treprostinil using an SMI and in that same patent, there's a single acute dose with the ultrasonic nebulizers that is Tyvaso as we know it today.

    所以,如果你回到 2006 年優先權日為 793 號專利,特別是查看示例一,它談到了使用 SMI 單劑量急性給藥曲前列尼爾,而在同一項專利中,還有使用超聲霧化器單劑量急性給藥,也就是我們今天所知的 Tyvaso。

  • And what that showed is that in PAH patients with a single dose, low dose, that cough was prevalent, and it describes the MMAD or the median diameter of those particles to be in the four to five-micron range. So nothing different. So you're giving Tyvaso solution.

    這表明,在接受單次低劑量治療的 PAH 患者中,咳嗽很普遍,這些顆粒的 MMAD 或中位數直徑在 4 到 5 微米範圍內。所以沒什麼不同。所以你們給泰瓦索公司提供了解決方案。

  • You're not doing anything to improve its tolerability or penetration to the lower airway, you're just using a different way to present an aerosolized mist. So it doesn't really matter if you use a soft mist inhaler, yes, that's probably better from a portability standpoint, but that will be it will still present itself clinically in terms of how it behaves as Tyvaso nebulized.

    你並沒有採取任何措施來提高其耐受性或下呼吸道的滲透性,你只是用不同的方式呈現霧化液而已。所以,使用軟霧吸入器其實並不重要,是的,從便攜性的角度來看,軟霧吸入器可能更好,但從臨床角度來看,它的表現仍然與霧化泰維索類似。

  • So we don't really view it as competitive. I think you'd have to ask the competitors to explain the comments they made around tolerability, they've said they still have to do bioequivalent. So whatever data they have, my guess is it's just single-dose acute studies in normal volunteers which is a very bad proxy for what may happen in patients with a high predilection of cough.

    所以我們不認為這是一場競爭。我認為你應該去問問競爭對手,讓他們解釋一下他們對耐受性的評論,他們說他們還需要進行生物等效性研究。所以,無論他們掌握什麼數據,我的猜測是,這只是對正常志願者進行的單劑量急性研究,這對於咳嗽傾向較高的患者可能出現的情況來說,是非常糟糕的替代指標。

  • And the truth to that statement is, remember, when they launched Tyvaso DPI, they had no data in patients that was done on bioequivalence in PH-ILD. And you've seeing the issues they've had through the National Jewish state, in particular, with the DPI and PH-ILD.

    而事實是,請記住,當他們推出 Tyvaso DPI 時,他們並沒有在 PH-ILD 患者中進行生物等效性研究的數據。你們也看到了他們在國家猶太國家遇到的問題,特別是與DPI和PH-ILD的問題。

  • And now it seems like they've capitulated and feel that DPIs are now not useful, at least their DPI and they're trying to pivot to another methodology, but I don't see that methodology as providing any forward-looking benefit.

    現在看來他們似乎已經屈服了,覺得 DPI 現在沒用了,至少他們自己的 DPI 沒用了,他們正在嘗試轉向另一種方法,但我認為這種方法不會帶來任何前瞻性的好處。

  • So that's kind of my quick view on it. I know, Rajeev, you have some broader statements around perspective because this has been tried before in other markets and if I could, I'd ask you to speak to those instances, if you will.

    以上就是我對此事的簡要看法。我知道,拉吉夫,你對視角有一些更廣泛的看法,因為這在其他市場已經嘗試過了,如果可以的話,我想請你談談那些例子。

  • Rajeev Saggar - Chief Medical Officer

    Rajeev Saggar - Chief Medical Officer

  • Yeah, sure. Thanks, Roger. So I think I just want to highlight some key points here. I think the signature of the SMI was primarily derived from the Spiriva Respimat and that was done at a time when the CFC propellants were being removed and also, there was a patent issue from that company, and they compared it to Spiriva HandiHaler, which is the dry powder formulation.

    當然可以。謝謝,羅傑。所以我想在這裡強調幾個要點。我認為 SMI 的特徵主要源自於 Spiriva Respimat,當時 CFC 推進劑正在被移除,而且該公司還存在專利問題,他們將其與 Spiriva HandiHaler(乾粉配方)進行了比較。

  • And at that time, the HandiHaler was the highest resistance device ever to be developed in patients with asthma and COPD, which is tens of millions of patients. The only device that has a higher resistance than the HandiHaler to date is actually the Tyvaso DPI device that's used in PAH and PH-ILD.

    當時,HandiHaler 是為氣喘和 COPD 患者(數千萬患者)開發的阻力最大的吸入器。迄今為止,唯一比 HandiHaler 阻力更大的設備實際上是用於 PAH 和 PH-ILD 的 Tyvaso DPI 設備。

  • But what's really interesting is with all the studies done comparing the softness inhaler to a dry powder inhaler using the same formulation in this regard with tiotropium, the SMI has never been shown to change the clinical efficacy, the pharmacokinetics and most importantly, who's never been shown to improve or modify safety and or tolerability inclusive of the concerns for cost. So I just want to highlight as what Roger spoke to that the SMI does not port any substantial benefit besides the portability itself.

    但真正有趣的是,所有比較軟式吸入器和使用相同配方噻托溴銨的乾粉吸入器的研究都表明,軟性吸入器從未被證明能夠改變臨床療效、藥物動力學,更重要的是,從未被證明能夠改善或改變安全性或耐受性,包括成本方面的考慮。因此,我只想強調羅傑所說的,SMI 除了便攜性本身之外,並沒有帶來任何實質的好處。

  • Operator

    Operator

  • Amy Li, Jefferies.

    Amy Li,傑富瑞集團。

  • Amy Li - Equity Analyst

    Amy Li - Equity Analyst

  • Hey, thanks so much for taking your question and, congrats on the momentum. So when we look at your path to the $1 billion revenue target in 2027 that you laid out, our math suggests that implies sustained patient adds from here.

    嘿,非常感謝你回答我的問題,也恭喜你取得如此好成績。因此,當我們審視您提出的到 2027 年實現 10 億美元營收目標的路徑時,我們的計算表明,這意味著從現在開始患者數量將持續增長。

  • So is that the right way to think about the trajectory? And more importantly, what gives you confidence in maintaining your current pace in the next couple of years? How much visibility do you have into the patient funnel and where the patient is coming from and then how -- and are you still confident in that number in light of kind of the potential emerging competitive dynamics like SMI?

    那麼,這種思考軌跡的方式是否正確呢?更重要的是,是什麼讓你有信心在未來幾年維持目前的發展速度?您對病患轉化流程、病患來源、轉換方式的了解程度如何?考慮到像SMI這樣潛在的新興競爭動態,您是否仍然對這個數字有信心?

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • So I'll ask Mike to speak to some of -- how we get there, at least from a revenue calculation standpoint. But as we just said, Amy, we don't see any influence from the SMI. I think it's -- again, it's going to be Tyvaso and perhaps a more portable format from using jet nozzles to create aerosolized particles.

    所以我會請麥克談談——至少從收入計算的角度來看,我們是如何實現這一目標的。但正如我們剛才所說,艾米,我們沒有看到SMI的任何影響。我認為——還是會是Tyvaso,而且可能會採用更便攜的形式,利用噴嘴產生氣溶膠顆粒。

  • But as I said, they're going to be poly dispersed, they're going to cause cough, they're going to have titration issues. So I don't really see that impacting us in any other way and as you're noting in the competitors' revenues, the nebulized business is decreasing, mostly because we're beginning to take that share away.

    但正如我所說,它們是多分散的,會引起咳嗽,而且會有滴定問題。所以我並不認為這會對我們產生任​​何其他影響,而且正如你從競爭對手的收入中指出的那樣,霧化業務正在減少,主要是因為我們開始搶佔這部分市場份額。

  • So I think more of that will continue to happen. Mike, do you want to talk about kind of how we see our sales continuing decline amounting towards greater at least $1 billion in revenue in 2027?

    所以我認為這種情況還會繼續發生。麥克,你想談談我們預計銷售額將持續下降,到 2027 年收入至少減少 10 億美元的情況嗎?

  • Michael Kaseta - Chief Financial Officer

    Michael Kaseta - Chief Financial Officer

  • Yes, Amy, thanks for the question. I mean if you just look at start with what I talked about earlier. The market for the quarter was over [$500 billion], which means it's about it's already on the inhaled treprostinil market is already a $2 billion market.

    是的,艾米,謝謝你的提問。我的意思是,如果你從我之前談到的內容開始看起。該季度的市場規模超過 5,000 億美元,這意味著吸入型曲前列尼爾市場已經達到 20 億美元。

  • You then talk about -- our share of that revenue has increased considerably quarter-over-quarter. We believe that will continue as well.

    然後您談到——我們在該收入中所佔的份額環比大幅增長。我們相信這種情況還會持續下去。

  • Then you look at the opportunity that we talked about in PAH with the $2 billion oral opportunity where we believe that there will be significant opportunity for us to gain significant share from that.

    然後,讓我們來看看我們在 PAH 領域討論過的 20 億美元口服藥物市場機會,我們相信我們將有機會從中獲得相當大的市場份額。

  • So that's another $2 billion opportunity just within PAH that we see. And then as Scott and Roger had said earlier, we're just scratching the surface in PH-ILD. We're enhancing our sales force. We're getting more penetration.

    所以,光是在多環芳烴領域,我們就看到了另一個價值 20 億美元的機會。正如 Scott 和 Roger 之前所說,我們對 PH-ILD 的了解還只是冰山一角。我們正在擴充銷售團隊。我們的市場滲透率正在提高。

  • We're getting further into the community. So when you look at the overall opportunity, our current $2 billion market opportunity in inhaled treprostinil plus the oral opportunity plus the enhanced white space in PH-ILD, we feel very bullish in our ability to continue on this trajectory and continue on this path to get us to what as Roger had said at JPM, YUTREPIA being a $1 billion product in 2027.

    我們正在更深入地融入社區。因此,當我們審視整體機會時,我們目前在吸入曲前列尼爾領域擁有 20 億美元的市場機遇,加上口服機遇,以及在 PH-ILD 領域不斷擴大的空白市場,我們對繼續保持這一發展軌跡並沿著這條道路前進的能力感到非常樂觀,正如 Roger 在摩根大通所說的那樣,YUTREPIA 將在 2012 年成為一款價值 200 億美元的產品。

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Yeah, I think the other thing, Amy, too -- great response, Mike, is, look, we're doing directed studies that we're going to transition patients from the competitive agents, either oral or inhaled and show the benefits of moving those patients to direct tolerability and efficacy.

    是的,艾米,我也認為還有一點——麥克的回答很棒——那就是,我們正在進行定向研究,目的是讓患者從競爭性藥物(無論是口服還是吸入)過渡到直接治療,並證明將這些患者轉移到直接治療的耐受性和療效方面的益處。

  • So all of these things just will continue to build a portfolio and a suite of evidence and data-driven proof that YUTREPIA is the best-in-class and first in choice product.

    因此,所有這些因素都將繼續建構產品組合和一系列證據及數據驅動的證明,證明 YUTREPIA 是同類最佳、首選的產品。

  • Operator

    Operator

  • Serge Belanger, Needham.

    Serge Belanger,尼德姆。

  • Serge Belanger - Analyst

    Serge Belanger - Analyst

  • Hi, good morning. First question on the legal front. Any new updates or developments that you can share with us?

    您好,早安。第一個問題是關於法律方面的。有什麼新的進展或訊息可以和我們分享嗎?

  • And then secondly, regarding payer access, I think you reported another 85% prescription to patient start conversion just curious how that number varies across the Medicare and Commercial segment and I guess, what additional coverage work is required.

    其次,關於支付方准入,我認為您報告的處方到患者開始治療的轉換率達到了 85%,我只是好奇這個數字在 Medicare 和商業保險領域有何不同,以及還需要做哪些額外的覆蓋工作。

  • I know you had coverage from three major commercial payers, but what additional payers need to come online over the remainder of 2026?

    我知道您有三家主要商業保險公司的保險,但到 2026 年剩餘時間裡,還需要哪些其他保險公司加入?

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Sure. Thanks for the question. So I'll take the legal and then I'll pass it to Mike for payer. So really nothing new from what we said at JPMorgan, Serge, so just a reminder for those who may be newer to the story, that the oral hearing was in June, post-trial briefings were completed in August.

    當然。謝謝你的提問。所以我先處理法律方面的事情,然後把它交給麥克付款。所以,Serge,這和我們在摩根大通所說的並沒有什麼新內容,只是提醒一下那些可能不太了解情況的人,口頭聽證會在6月份舉行,審後簡報在8月份完成。

  • So we're now approaching nine months from trial and seven months from the post-trial briefing. So we do think we're in the sweet spot for when an opinion should and could be rendered. But obviously, it's been taking longer than we all expected.

    現在距離審判已經過了九個月,距離審後情況通報會已經過了七個月。所以我們認為,我們正處於發表意見的最佳時機。但很顯然,這比我們所有人預期的都要花費更長時間。

  • So we can't really probabilitize on when it actually will come down. What I would say is we remain very confident in the arguments that we made and we strongly believe that we should win and the case should read out favorably to us.

    所以我們無法準確預測它何時會倒塌。我想說的是,我們仍然對我們提出的論點非常有信心,我們堅信我們應該獲勝,案件的判決結果應該對我們有利。

  • We acknowledge there's a lot of potential options here or outcomes. But regardless of what happens, we're prepared for any and all outcomes. So really nothing new to state today other than we remain confident in our position and look forward to hearing from the judge in due time. So Mike, if you'll talk to payer access, please.

    我們承認這裡有很多潛在的選擇或結果。但無論發生什麼,我們都已做好應對任何結果的準備。所以今天沒有什麼新的要說的,我們仍然對自己的立場充滿信心,並期待在適當的時候收到法官的裁決。所以麥克,請你和支付方談談吧。

  • Michael Kaseta - Chief Financial Officer

    Michael Kaseta - Chief Financial Officer

  • Yeah, sir. So it's great to hear from you. I think where we are with payer and pull-through is just another example of how we've executed on this launch.

    是的,先生。很高興收到你的來信。我認為我們在支付方和推廣方面所取得的成就,正是我們此次產品發布執行情況的又一例證。

  • Scott and his team have done a masterful job, the fact that we are at -- we've maintained 85% plus of pull-through from really the very early stages of the launch is just simply staggering. And we continue on that pace.

    Scott 和他的團隊做得非常出色,事實上,從產品上市初期到現在,我們的成交率一直保持在 85% 以上,這簡直令人震驚。我們將繼續保持這個速度。

  • We've also said from the beginning of the launch was our goal was to make sure that patients have a choice if they want to use YUTREPIA and what we can say is we've achieved that and we continue to work through our pull-through, making sure that we provide a suite of services to patients to make sure that if they want YUTREPIA, they can get it.

    從產品上市之初,我們就說過我們的目標是確保患者在是否使用 YUTREPIA 方面擁有選擇權,而我們現在可以說,我們已經實現了這一目標,並且我們將繼續努力推進推廣工作,確保我們為患者提供一系列服務,以確保如果他們想要 YUTREPIA,他們就能得到它。

  • And I think that's evident in that pull-through percentage, and we don't see any change in that coming. And our goal will always be to improve that as we move forward. But I really think we're already in a best-in-class state being at 85-plus percent pull-through percentage.

    我認為這從成交率就能看出來,而且我們預計這種情況不會有任何改變。我們的目標始終是不斷改進。但我真的認為我們已經處於一流水平,成交率超過 85%。

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Great, thanks, Mike. Operator, next question.

    太好了,謝謝你,麥克。操作員,下一個問題。

  • Operator

    Operator

  • Ben Burnett, Wells Fargo.

    本·伯內特,富國銀行。

  • Ben Burnett - Analyst

    Ben Burnett - Analyst

  • Hey, thanks very much and congrats on all the progress. I just wanted to see if I could get a little bit of color on some of the launch dynamics into the first quarter. Anything you can say kind of around inventory stocking trends or kind of the refill rate that you're seeing?

    嘿,非常感謝,也祝賀你取得的所有進展。我只是想看看能否對第一季的上市動態做一些描述。您能否談談您觀察到的庫存趨勢或補貨率的情況?

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Yeah, Mike, if you wouldn't mind commenting on that?

    麥克,你介意就此發表一下看法嗎?

  • Michael Kaseta - Chief Financial Officer

    Michael Kaseta - Chief Financial Officer

  • Yeah, Ben, thanks for the question. As we said in our press release, and Roger reiterated already, we've already had a strong January and February when it comes to both new patient starts and referrals. We're staying on the exact same trajectory we were on in Q4.

    是的,本,謝謝你的提問。正如我們在新聞稿中所說,羅傑也重申過,無論是新患者就診量還是轉診量,我們在一月和二月都取得了強勁的成績。我們將繼續沿著與第四季完全相同的軌跡前進。

  • We've often gotten questions from analysts and from comments from our competitors about seasonality. We've seen nothing but increases across the Board.

    我們經常收到分析師的提問和競爭對手的評論,內容都與季節性有關。我們看到的是全面成長。

  • And as we showed today, we continue to see those increases. So as we've always said, as Roger had said, we are still very confident as we move through the rest of Q1 into Q2 and are on our path to be a $1 billion product in 2027.

    正如我們今天所展示的,我們繼續看到這些成長。正如我們一直所說,正如羅傑所說,我們仍然非常有信心,在順利度過第一季度剩餘時間進入第二季度之際,我們將朝著在 2027 年成為一款價值 10 億美元的產品的目標穩步前進。

  • Now as it relates to inventory and stocking, I think we're now at the point of the launch nine months in, where we've really normalized and I don't expect there to be any significant swings now.

    就庫存和備貨而言,我認為現在已經到了產品上市九個月後的階段,庫存和備貨已經真正趨於正常化,我預計現在不會再出現任何大的波動。

  • Specialty distributors can make decisions that ended up quarters that we don't have influence over. But at the end of the day, we are tracking well our demand is extremely strong. And as a result, we feel very confident in the revenue as we move forward.

    專業分銷商可以做出一些我們無法影響的季度決策。但歸根結底,我們的進展順利,需求非常強勁。因此,我們對未來的收入充滿信心。

  • Ben Burnett - Analyst

    Ben Burnett - Analyst

  • Okay. That's extremely helpful. And I guess just also regarding the systemic sclerosis RP program. I thought that was interesting. Could you maybe walk us through kind of the evidence in support of treprostinil and kind of what your path forward is there?

    好的。這非常有幫助。我想也想談談系統性硬化症RP計畫。我覺得這很有趣。您能否為我們介紹一下支持曲前列尼爾的證據,以及您接下來的研究方向?

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Yeah, I'd love to, so Rajeev, if you wouldn't mind talking about the Raynaud's program?

    是的,我很樂意。拉吉夫,如果你不介意的話,能不能談談雷諾氏症的治療方案?

  • Rajeev Saggar - Chief Medical Officer

    Rajeev Saggar - Chief Medical Officer

  • Yeah, sure. Thanks for the question. So obviously, systemic sclerosis is a rare condition overall. And obviously, by the nature of they're the actual topic of systemic means they have multiple disorders affecting multiple organ dysfunctions inclusive of the most deadly, which is and PAH and PH-ILD.

    當然可以。謝謝你的提問。顯然,系統性硬化症總體而言是一種罕見疾病。顯然,就其性質而言,它們是系統性疾病的實際主題,它們有多種疾病影響多個器官功能障礙,包括最致命的肺動脈高壓 (PAH) 和肺動脈高壓-間質性肺病 (PH-ILD)。

  • And despite that, their single most complaint of what drives their quality of life is the problem that occurs with Raynaud's phenomenon, which occurs in at least and it's debatable, but somewhere between 90% to 95% of all patients with systemic sclerosis or scleroderma.

    儘管如此,影響他們生活品質的最大抱怨還是雷諾氏現象,這種現象至少發生在 90% 到 95% 的系統性硬化症或硬皮症患者中(雖然有爭議)。

  • The reason why we think we have good rationale is that actually many of the drugs that have been approved for pulmonary hypotension have been studied, specifically on the and the complication of Raynaud's phenomenon, which is known as digital ulcers inclusive of prostacyclins.

    我們認為我們有充分理由的原因是,實際上許多已獲批准用於治療肺動脈低血壓的藥物都經過了研究,特別是針對雷諾現象的併發症,即指端潰瘍,包括前列環素類藥物。

  • In fact, in the European and the US guidelines for the management of Raynaud's phenomenon, iloprost and or Flolan is used as salvage therapy in the event that patients are recalcitrant to treatments such as calcium channel blockers and or even PD5 inhibitors, which is used off label.

    事實上,在歐洲和美國的雷諾現像管理指南中,如果患者對鈣通道阻斷劑和/或 PD5 抑制劑等治療無效,則使用伊洛前列素和/或弗洛蘭作為補救治療,這是超適應症用藥。

  • So that just shows that the prostacyclin class in and of itself is able to prevent worsening of ischemic episodes. They're potentially leading to avoiding issues of gangrene and or amputation of these digits that's affecting these patients.

    這顯示前列環素類藥物本身能夠防止缺血性發作惡化。它們有可能避免這些患者面臨的壞疽和/或截肢問題。

  • One of the challenges oral treprostinil was studied in condition, again, to try to modify the digital ulcers. The problem with that was the trial was fraught with tolerability issues and patients coming off because of the intolerability of oral treprostinil, again, highlighting that if we can provide YUTREPIA for these patients, we know that the tolerability profile of inhaled treprostinil has significantly improved.

    口服曲前列尼爾面臨的挑戰之一是再次嘗試改善指端潰瘍。但問題在於,該試驗充滿了耐受性問題,許多患者因為無法耐受口服曲前列尼爾而停止治療,這再次表明,如果我們能為這些患者提供 YUTREPIA,我們就知道吸入曲前列尼爾的耐受性已經顯著改善。

  • We can also -- we also know from our data that we can dose to a significantly high level, ensuring that we obtain appropriate pharmacokinetic profile to modify the disease and so we look forward to initiating our Phase 2 program in systemic sclerosis RP here in near the end of the year.

    我們也可以從數據中得知,我們可以將劑量提高到相當高的水平,從而確保獲得適當的藥物動力學特徵來改變疾病,因此我們期待在今年年底前啟動系統性硬化症RP的2期計畫。

  • Operator

    Operator

  • Jason Gerberry, Bank of America.

    傑森‧格伯里,美國銀行。

  • Jason Gerberry - Analyst

    Jason Gerberry - Analyst

  • Hey guys, thanks for taking my question. So two for me. Just first on PAH, I wanted to just get your view on sort of the role for an inhaled treprostinil in the PAH setting. It's a bit confusing and so -- on the one hand, your competitor flagged that maybe inhalation approaches are going to see a diminished role in PAH.

    各位好,感謝你們回答我的問題。所以我要兩個。首先,關於肺動脈高壓 (PAH),我想了解您對吸入曲前列尼爾在 PAH 治療中的作用的看法。這有點令人困惑,所以——一方面,你的競爭對手指出,吸入療法在 PAH 治療中的作用可能會減弱。

  • And then when we talk to KOLs, what they're saying is they're not putting new starts on UPTRAVI but yet when we look at IQVIA data, the UPTRAVI NRx look pretty stable.

    然後,當我們與 KOL 交談時,他們表示他們不會在 UPTRAVI 上進行新的啟動,但是當我們查看 IQVIA 數據時,UPTRAVI NRx 看起來相當穩定。

  • So there's a lot of conflicting data points in this, and it's a dynamic space. Winrevair is now getting used more in newly diagnosed PAH. So how do you see this dynamic where the role of, say, oral versus an inhaled prostacyclins in PAH?

    所以這方面有很多相互矛盾的數據點,而且這是一個動態的領域。Winrevair 目前越來越多地用於新診斷的肺動脈高壓患者。那麼,您如何看待這種動態變化,例如口服前列環素與吸入前列環素在肺動脈高壓中的作用?

  • And then my second question for Mike, just when I look at fourth quarter numbers, it looks like really good revenue recognition per patient to take the average the 3Q number versus the 4Q number over sales or under sales, I should say.

    然後,我的第二個問題是問麥克,當我查看第四季度的數據時,看起來每位患者的收入確認情況非常好,應該說是將第三季度的數據與第四季度的數據進行比較,看看銷售額是高於還是低於銷售額。

  • So when we look ahead to 2026, it doesn't seem like that there's going to be a huge gross to net adjustment in the numbers relative to the patients and the revenue capture but wanted to get your perspective there.

    所以展望 2026 年,就患者數量和收入而言,似乎不會出現毛利和淨利之間的巨大調整,但我想聽聽您的看法。

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Yeah. Thanks for the question, Jason. So I'll speak to the PAH issue in terms of oral versus inhaled. And I think the field is moving. The paradigm is shifting to where patients aren't going to be willing to accept off-target effects any longer.

    是的。謝謝你的提問,傑森。所以,我將從口服和吸入的角度來談談多環芳烴的問題。我認為這個領域正在改變。人們的觀念正在轉變,患者將不再願意接受藥物的非標靶副作用。

  • And because the burden of those off-target effects can be as bad as the burden of the disease in terms of impact on daily living.

    因為這些非標靶效應所帶來的負擔,就對日常生活的影響而言,可能與疾病本身帶來的負擔一樣嚴重。

  • So the orals, clearly, if you look at the frequency of AEs related to the GI toxicities, they're significant, and they occur daily, they occur over hours in the day and if you then pair that with minimal symptomatic benefit to the disease, that benefit to risk exchange is not a good negotiation for the patient.

    所以很明顯,口服藥物的胃腸道毒性相關不良事件的發生頻率很高,而且每天都會發生,一天中會持續數小時。如果再加上對疾病症狀的改善效果微乎其微,那麼這種風險效益比對患者來說就不是一個好的選擇。

  • So I think going forward, particularly as we continue to evolve data around the ability of YUTREPIA to dose titrate drive effect and really eradicate off target effects to the GI or from parenteral issues related to septicemia and subcutaneous site pain and irritation.

    因此,我認為展望未來,特別是隨著我們不斷完善有關 YUTREPIA 劑量滴定驅動效應以及真正消除對胃腸道或與敗血症和皮下部位疼痛和刺激相關的腸外問題的脫靶效應的數據。

  • There really -- there's -- nobody would be willing to make a trade-off because now you can get the symptomatic benefit without sacrificing your daily living through these off-target effects.

    確實——確實——沒有人願意做出這樣的權衡,因為現在你可以在不犧牲日常生活的情況下獲得症狀緩解,而無需承受這些非靶向副作用的影響。

  • So I do think -- and our competitors said it when they spoke about their SMIs, like the people are tired now of off-target effects and their people what you want to see is a better benefit to risk profile, which YUTREPIA provides.

    所以我認為——我們的競爭對手在談到他們的SMI時也說過——人們現在厭倦了非靶向效應,他們想要看到的是更好的風險收益比,而YUTREPIA提供了這種收益。

  • And then it is a 4 times a day therapy, so that would be the only sort of negative there. We're going to negate that negative with L606. So the imports of that studies will achieve in a different way through liposomal encapsulation, all the benefits of YUTREPIA but then now we'll do it in a twice-a-day format and it will also minimize peak-to-trough excursions so that trough benefit is steady to the peak benefit.

    而這種療法一天要進行四次,所以這大概是唯一的缺點了。我們將用 L606 來抵消這種負面影響。因此,透過脂質體封裝,該研究成果將以不同的方式實現,獲得 YUTREPIA 的所有益處,但現在我們將以每天兩次的形式進行,並且還將最大限度地減少峰谷波動,使谷值收益與峰值收益保持穩定。

  • So what we're trying to do at this company is really improve patient outcome, have patients feel better, remove these off-target effects and then get them to a point in time where they can take an easy portable therapy without risk. So I think we're well on our way to doing that.

    所以,我們公司努力的目標是真正改善患者的治療效果,讓患者感覺更好,消除這些非標靶效應,然後讓他們能夠安全地接受便捷的便攜式治療。所以我覺得我們正朝著這個目標穩步前進。

  • I think clearly, YUTREPIA's become the preferred inhaled and as we continue to sort of cannibalize share from orals, you'll see more and more of that.

    我認為很明顯,YUTREPIA 已經成為首選的吸入式藥物,隨著我們不斷蠶食口服藥物的市場份額,你會看到越來越多的吸入式藥物出現。

  • So again, very excited that across the board. And I think that's it for the PAH to oral. So maybe, Mike, if you can talk about the fourth quarter dynamics?

    所以,再次強調,我對各方面都感到非常興奮。我認為關於 PAH 口服途徑就到此為止了。麥克,你能談談第四季的動態嗎?

  • Michael Kaseta - Chief Financial Officer

    Michael Kaseta - Chief Financial Officer

  • Yeah, Jason, thanks for the question. So as we look at our growth to net from 2025, to 2026. As we had said in previous quarters, working on access in the back half of the year, we had some new to market blocks that had existed on the commercial front. Those were slowly removed. The result of that is going to be twofold.

    是的,傑森,謝謝你的提問。因此,讓我們展望一下 2025 年至 2026 年的淨成長情況。正如我們在前幾個季度所說,在下半年努力爭取土地使用權時,我們在商業方面獲得了一些新的市場區塊。它們被慢慢地移除了。這樣做會產生雙重結果。

  • One, we will pay more rebates on more of our business as we move forward in 2026. But that will be offset by having more patients having access.

    第一,隨著我們業務在 2026 年的推進,我們將為更多業務支付更多退稅。但更多患者能夠獲得治療將抵消這項影響。

  • So what I would say is, as we have kept saying we are extremely confident in our trajectory as we move into '26, and into '27, but what I would say is maybe there'll be a very small incremental increase in our gross to net, but that is -- it goes to our goal of making sure patients have choice and patients have access.

    所以我想說的是,正如我們一直所說,我們對2026年和2027年的發展軌跡非常有信心,但我想說的是,我們的毛利潤和淨利潤可能會有非常小的增量增長,但這——是為了確保患者有選擇權和獲得醫療服務的目標。

  • So we will have achieved that goal and I think we'll sit at a place where we're very comfortable and can still achieve our goals in 2026, and as we've said, being a $1 billion product in 2027.

    因此,我們將實現這一目標,我認為我們將處於一個非常有利的位置,並且仍然可以在 2026 年實現我們的目標,正如我們所說,在 2027 年成為一款價值 10 億美元的產品。

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Operator, I think we have time for one more question.

    接線員,我想我們還有時間再回答一個問題。

  • Operator

    Operator

  • Gaurav Maini, LifeSci Capital.

    Gaurav Maini,生命科學資本。

  • Gaurav Maini - Equity Analyst

    Gaurav Maini - Equity Analyst

  • Hey, good morning, everyone. congrats on a great print and continued strong launch of YUTREPIA. Just two for me, if that's okay can the team give some color on that one in four prostacyclin transition patients and kind of what bucket of prostacyclin therapy, oral versus inhaled, these patients are coming from?

    大家好,早安!恭喜YUTREPIA印刷品大獲成功,並持續保持強勁的上市勢頭。我只需要兩個問題,如果可以的話,團隊能否詳細說明一下四分之一的前列環素轉換患者的情況,以及這些患者接受的是哪種前列環素治療(口服還是吸入)?

  • And then secondly, on the new exploratory YUTREPIA trials, can you just describe how these are expected or if they are, I guess, to be label enhancing?

    其次,關於新的探索性 YUTREPIA 試驗,您能否描述一下這些試驗的預期效果,或者它們是否會增強現有標籤的效果?

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Yeah, so maybe I'll ask Scott to talk about sort of how the transition market, kind of the demographics of that and then Rajeev, if you will speak to the benefits of the trials that we're doing so Scott?

    是的,那我或許可以請 Scott 談談過渡市場的情況,以及相關的人口統計數據,然後 Rajeev,Scott,你能談談我們正在進行的試驗的好處嗎?

  • Scott Moomaw - Chief Commercial Officer

    Scott Moomaw - Chief Commercial Officer

  • Sure. So as we've said, you alluded to, we've said that 75% of the patients are new to prostacyclin and then 25% are switch. Obviously, in PH-ILD, there aren't other options. So it's -- those switches are coming from inhaled in PAH, what we said is that about 30% of the 25% in PAH are coming from the orals.

    當然。正如我們所說,正如你所提到的,我們說過,75% 的患者是第一次使用前列環素,然後 25% 的患者是換用前列環素。顯然,在PH-ILD中,沒有其他選擇。所以——這些轉換來自吸入性多巴胺,我們說過,多巴胺患者中約有 25% 的轉換來自口服。

  • And then the bulk of those are coming the rest of those are coming from inhaled. Now we are starting to see more patients transition off of parenterals on to YUTREPIA, I don't think that's going to necessarily become material in terms of the switches, but it is interesting and shows that in the future, we'll probably kind of encroach on the parenteral space.

    其中大部分來自吸入,其餘的則來自吸入。現在我們開始看到越來越多的患者從腸外給藥過渡到使用 YUTREPIA,我認為這在轉換方面不一定會變得實質性,但這很有趣,也表明在未來,我們可能會在某種程度上蠶食腸外給藥市場。

  • But when I'm out there in the market, I can tell you that the enthusiasm around using YUTREPIA instead of the oral prostacyclins for all the reasons Roger elucidated earlier, is only growing and so we think that whether they're switching the patient off of an oral prostacyclin or they're using YUTREPIA instead of an oral prostacyclin, again, I think there is a big opportunity there for us.

    但是,當我在市場上觀察時,我可以告訴你,人們對使用 YUTREPIA 代替口服前列環素的熱情,正如 Roger 之前闡述的那樣,只會越來越高。因此,我們認為,無論他們是讓患者停用口服前列環素,還是用 YUTREPIA 代替口服前列環素,我認為這對我們來說都是一個巨大的機會。

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • All right, thank you, Scott. So Rajeev, if you'll speak to the trials, please.

    好的,謝謝你,斯科特。所以拉吉夫,如果你願意的話,請你談談審判事宜。

  • Rajeev Saggar - Chief Medical Officer

    Rajeev Saggar - Chief Medical Officer

  • Yeah, thanks for the question. So listen, I firmly believe we're entering into a decade and beyond of inhaled renaissance here in PAH and in PH-ILD. And I think YUTREPIA is leading the charge today, and L606 is going to definitely beat it tomorrow.

    謝謝你的提問。所以聽著,我堅信,在 PAH 和 PH-ILD 領域,我們將迎來吸入療法復興的十年甚至更久。我認為 YUTREPIA 目前處於領先地位,而 L606 明天肯定會超過它。

  • In that regard, the trials that we are purposely conducting is defining how to switch from the oral prostanoid to YUTREPIA.

    在這方面,我們正在進行的試驗旨在確定如何從口服前列腺素類藥物過渡到 YUTREPIA。

  • I think we highlighted a few things on this call. Number one, it is very clear that practitioners across the board are very interested in delivering the most tolerable drug. I think this has been highlighted by the addition of sotatercept to the armamentarium, which has, I think, completely negated and limited the utility of parenteral therapies at this time.

    我認為我們在這次通話中重點討論了幾個問題。首先,很明顯,所有從業人員都非常關注如何提供耐受性最好的藥物。我認為,索他西普的加入凸顯了這一點,我認為,索他西普的加入完全否定並限制了目前腸外療法的效用。

  • We have several large anecdotal cases of YUTREPIA being used acutely in the hospital and to combine that also with sotatercept to maximize the benefit of that combination. In regards to oral prostanoids, we plan to switch studies from selexipag to YUTREPIA.

    我們有幾例大型軼事案例表明,YUTREPIA 在醫院被緊急使用,並且與 sotatercept 結合使用,以最大限度地發揮該組合的益處。關於口服前列腺素類藥物,我們計劃將研究從司來帕格轉向 YUTREPIA。

  • It would detail to the practitioners how to do that effectively and safely. And also, again, the advantage of YUTREPIA is that we can dose 2 times to 4 times that typically what is used traditionally by Tyvaso. In those studies, we'll also highlight some of the hemodynamic capacity of YUTREPIA, which I think would be very exciting.

    它將向從業人員詳細說明如何有效、安全地進行這項工作。此外,YUTREPIA 的優點在於,我們可以給予 Tyvaso 傳統用藥劑量的 2 到 4 倍。在這些研究中,我們還將重點介紹 YUTREPIA 的一些血液動力學能力,我認為這將非常令人興奮。

  • In regard to label enhancing, I think we reserve the right to always present our data to the agency for consideration for label discussions in that regard and then finally, I think we've highlighted just -- to highlight again the sotatercept study.

    關於標籤增強,我認為我們始終保留向監管機構提交資料以供其考慮進行標籤討論的權利,最後,我認為我們已經強調了——再次強調一下 sotatercept 研究。

  • The purpose of this study is to transition patients that are on sotatercept in combination with either forms of prostanoid inclusive of parenteral and or oral and transition those off those therapies safely and effectively to YUTREPIA. So those are the studies that we are keenly and working across to initiate this year.

    本研究的目的是安全有效地將正在接受索他西普聯合任何形式的前列腺素(包括腸外或口服)治療的患者過渡到使用 YUTREPIA,並將停止這些治療的患者過渡到使用 YUTREPIA。所以,這些就是我們今年正在積極進行並努力啟動的研究計畫。

  • Roger Jeffs - Chief Executive Officer, Director

    Roger Jeffs - Chief Executive Officer, Director

  • Thank you, Rajeev there. Well said both from you and Scott. So I'll close by just saying as you can hear, Liquidia is all-in for our patients and trying to provide better and better opportunities, both now and in the future and we look forward to speaking with everyone again in May when we update you on our Q1 outcome. Thank you, everyone.

    謝謝你,拉吉夫。你和斯科特都說得很好。最後我想說的是,正如你們所聽到的,Liquidia 全心全意為我們的患者服務,並努力提供越來越好的機會,無論現在還是將來。我們期待在五月再次與大家交流,屆時我們將向大家報告第一季的業績。謝謝大家。

  • Operator

    Operator

  • Thank you. This concludes the conference.

    謝謝。會議到此結束。

  • Thank you for your participation. You may now disconnect.

    感謝您的參與。您現在可以斷開連線了。