Ascendis Pharma A/S (ASND) 2025 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • (audio in progress) to the third quarter 2025 Ascendis Pharma earnings conference Call. (Operator Instructions)

    (音訊播放中)Ascendis Pharma 2025 年第三季財報電話會議。(操作說明)

  • I would now like to turn the call over to Chad Fugere, Vice President of Investor Relations at Ascendis Pharma. Please go ahead.

    現在我將把電話交給 Ascendis Pharma 的投資者關係副總裁 Chad Fugere。請繼續。

  • Chad Fugere - President, CEO

    Chad Fugere - President, CEO

  • Thank you, operator, and thank you, everyone, for joining our third quarter 2025 financial results conference call. I'm Chad Fugere, Vice President of Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Executive Vice President and Chief Financial Officer; Sherrie Glass, Chief Business Officer; Jay Wu, EVP and President, US Market; and Aimee Shu, EVP and Chief Medical Officer.

    謝謝接線員,也謝謝各位參加我們2025年第三季財務業績電話會議。我是查德‧富格爾 (Chad Fugere),Ascendis Pharma 投資者關係副總裁。今天與我一起參加電話會議的有:總裁兼首席執行官 Jan Mikkelsen;執行副總裁兼首席財務官 Scott Smith;首席商務官 Sherrie Glass;執行副總裁兼美國市場總裁 Jay Wu;以及執行副總裁兼首席醫療官 Aimee Shu。

  • Before we begin, I'd like to remind you that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of SKYTROFA and YORVIPATH as well as certain expectations regarding patient access and financial outcomes, our pipeline candidates and expectations with respect to their continued progress and potential commercialization, our strategic plans, partnerships and investments, our goals regarding our clinical pipeline, including the timing of clinical results and trials, our ongoing and planned regulatory filings and our expectations regarding the timing and the result of regulatory decisions.

    在會議開始之前,我想提醒各位,本次電話會議將包含前瞻性陳述,這些陳述旨在受到《私人證券訴訟改革法案》所提供的安全港條款的保護。此類聲明的例子可能包括但不限於:關於我們 SKYTROFA 和 YORVIPATH 的商業化和持續開發的聲明,以及關於患者獲取和財務結果的某些預期、我們的在研候選藥物及其持續進展和潛在商業化的預期、我們的戰略計劃、合作夥伴關係和投資、我們關於臨床研發管線的目標(包括臨床結果和監管結果的計劃時間以及我們正在進行的時間安排和監管結果的監管時間以及我們正在進行的時間規劃數據(包括臨床結果和監管時間對我們正在進行的時間進行監管和監管結果(包括臨床結果和監管時間的計劃)。

  • These statements are based on information that is available to us as of today. Actual results may differ materially from those in our forward-looking statements, and you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning these factors that could cause actual results to differ materially, please see our forward-looking statements section in today's press release and the Risk Factors section of our most recent annual report on Form 20-F filed with the SEC on February 12, 2025.

    這些聲明是基於我們截至目前為止所掌握的資訊。實際結果可能與我們的前瞻性聲明有重大差異,您不應過度依賴這些聲明。除法律另有規定外,我們不承擔因情況變更而更新這些聲明的義務。有關可能導致實際結果與預期結果存在重大差異的這些因素的更多信息,請參閱我們今天新聞稿中的前瞻性聲明部分以及我們於 2025 年 2 月 12 日向美國證券交易委員會提交的最新 20-F 表格年度報告中的“風險因素”部分。

  • TransCon Growth Hormone or TransCon hGH, is now approved in the US by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency. In addition to the treatment of pediatric growth hormone deficiency and the EU has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency. TransCon PTH is approved in the U.S. by the FDA for the treatment of hypoparathyroidism in adults and the European Commission and the United Kingdom's Medicines and Healthcare products Regulatory Agency have granted marketing authorization for TransCon PTH as a replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism.

    TransCon 生長激素或 TransCon hGH 現已獲得美國 FDA 批准,用於取代生長激素缺乏症成人體內的內源性生長激素。除了用於治療兒童生長激素缺乏症外,歐盟還獲得了歐盟委員會頒發的用於治療兒童生長激素缺乏症的上市許可授權。TransCon PTH 已獲得美國 FDA 批准,用於治療成人甲狀旁腺功能減退症;歐盟委員會和英國藥品和保健產品監管局也已授予 TransCon PTH 上市許可,作為替代療法,用於治療成人慢性甲狀旁腺功能減退症。

  • Otherwise, please note that our product candidates are investigational and not approved for commercial use. As investigational products, the safety and effectiveness of product candidates have not been reviewed or approved by any regulatory agency. None of the statements during this conference call regarding our product candidates shall be viewed as promotional. On the call today, we'll discuss our third quarter 2025 financial results, and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for questions.

    另外,請注意,我們的候選產品尚處於研究階段,尚未獲準商業用途。作為研究性產品,候選產品的安全性和有效性尚未經過任何監管機構的審查或批准。本次電話會議中所有關於我們候選產品的發言均不應被視為促銷活動。在今天的電話會議上,我們將討論我們 2025 年第三季的財務業績,並提供進一步的業務更新。在作完一些事先準備好的發言後,我們將開放提問環節。

  • With that, let me turn it over to Jan.

    那麼,接下來就交給 Jan 來介紹吧。

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Thanks, Chad. Good afternoon, everyone. In the third quarter of 2025, we accelerated our momentum towards fulfilling our Vision 2030 with key achievements in three areas. First, the global launch of YORVIPATH continues to be strong with a steady increase in new unique patient prescription and prescribers as seen in Q1 and Q2, along with expansion in new geographic markets. Second, we made great advancement towards leadership in growth disorders during the quarter. We saw the US approval of SKYTROFA in adult growth hormone deficiency. And following our late cycle meeting with FDA, we are progressing towards expected approval of TransCon CNP in the US Third, our strong operating fundamentals led to positive operating profit, signaling the beginning of sustained revenue and earnings growth for Ascendis.

    謝謝你,查德。大家下午好。2025 年第三季度,我們在三個領域取得了關鍵成就,加快了實現 2030 年願景的步伐。首先,YORVIPATH 的全球上市持續保持強勁勢頭,第一季和第二季新增的獨特患者處方和處方醫生數量穩步增長,同時在新地域市場也實現了擴張。第二,本季我們在生長障礙領域取得了巨大的領先地位。我們看到美國批准了 SKYTROFA 用於治療成人生長激素缺乏症。第三,在與 FDA 進行後期會議後,我們正朝著 TransCon CNP 在美國獲得預期批准的目標穩步前進。此外,我們強勁的營運基本面帶來了正的營業利潤,這標誌著 Ascendis 開始實現持續的收入和獲利成長。

  • Now I will provide some specific comments on our commercial and late-stage portfolio. Starting with YORVIPATH. YORVIPATH continues its strong global launch with revenue of EUR143 million in the third quarter. 9 months in the launch in the biggest market, the US patient demand continues growing quarter-by-quarter. From launch to the end of September, more than 4,250 patients have been prescribed YORVIPATH in the US by over 2,000 unique healthcare providers, highlighting the strong steady demand for YORVIPATH even during the summer months. In October, the positive trend continued with YORVIPATH being prescribed for more than 400 new patients in the US alone.

    現在我將對我們的商業化和後期階段產品組合做一些具體說明。從 YORVIPATH 開始。YORVIPATH持續維持強勁的全球市場表現,第三季營收達1.43億歐元。該產品在美國這最大市場上市9個月以來,患者需求持續逐季成長。從上市到 9 月底,美國已有超過 2000 名不同的醫療保健提供者為超過 4250 名患者開立了 YORVIPATH 處方,這凸顯了即使在夏季,YORVIPATH 的需求依然強勁穩定。10 月份,這一積極趨勢仍在繼續,僅在美國就有 400 多名新患者被開了 YORVIPATH 處方。

  • Positive physician and patient experience are driving a high rate of compliance. And we expect most patients will be on lifelong PTH therapy. We are expanding our physician reach each quarter within the endocrinology community, and we are also expanding to other physician groups who manage hypopara patients. As an example, at last week's American Society of Nephrology meeting, we presented three years of kidney function data across our combined clinical trials, demonstrated sustained clinical meaningful improvement in kidney function in the YORVIPATH-treated patients. In addition, we continue working hard to expand patient access in the US. The overall insurance approval rate since the start of the launch is around 70% of total enrollment, and we believe this figure will continue to increase over time.

    良好的醫病體驗是提高依從率的關鍵因素。我們預計大多數患者將需要終身接受PTH治療。我們每季都在擴大在內分泌學界的醫生覆蓋範圍,同時也向其他治療甲減患者的醫師群拓展業務。例如,在上週的美國腎臟病學會會議上,我們展示了我們聯合臨床試驗三年來的腎功能數據,證明接受 YORVIPATH 治療的患者腎功能得到了持續的、具有臨床意義的改善。此外,我們將繼續努力擴大美國患者的就醫途徑。自該計劃啟動以來,整體保險審批率約為總註冊人數的 70%,我們相信這一數字會隨著時間的推移而繼續增長。

  • We currently see approvals across all payer types with a majority of approvals within 8 weeks. We are pleased by the robust uptake of YORVIPATH in our first three quarters of commercialization in the US. Today, less than 5% of US patients are currently on YORVIPATH treatment. We see significant room to grow with around 80,000 to 90,000 patients already diagnosed with chronic hypopara in the US and 3,000 to 4,000 new patients being diagnosed every year. Outside the US, YORVIPATH is now available commercially or through named patient program in more than 30 countries. In Germany, Austria and Spain, we have now full commercial reimbursement.

    目前我們看到所有類型的付款方都已批准,其中大部分審批在 8 週內完成。我們很高興看到 YORVIPATH 在美國商業化的前三個季度取得了強勁的市場反應。目前,美國祇有不到 5% 的患者正在接受 YORVIPATH 治療。我們看到了很大的成長空間,目前美國已有約 8 萬至 9 萬名患者被診斷出患有慢性副甲狀腺功能減退症,而且每年還有 3,000 至 4,000 名新患者被診斷出患有此病。在美國以外,YORVIPATH 目前已在 30 多個國家/地區透過商業管道或指定患者計畫提供。在德國、奧地利和西班牙,我們現在可以享受全額商業報銷。

  • In Japan, our partner, Teijin, launched YORVIPATH commercially last week following approval in August. We are looking forward to the commercial launch of YORVIPATH in additional countries in the coming years. With a broad label covering hypoparathyroidism for all causes, international treatment guidelines that recommend PTH replacement therapy and YORVIPATH position as first-in-class therapy, we expect sustained patient growth and revenue growth for years to come. As we're building this global market, we're expanding our offerings to patients with hypopara. We are conducting the PaTHway60 trial to support doses up to 60 micrograms of YORVIPATH in the US.

    在日本,我們的合作夥伴帝人公司在8月獲得批准後,上週正式推出了YORVIPATH。我們期待在未來幾年內,YORVIPATH能在更多國家實現商業化上市。YORVIPATH 具有涵蓋所有病因引起的副甲狀腺功能減退症的廣泛標籤,國際治療指南推薦 PTH 替代療法,並且作為同類首創療法,我們預計未來幾年患者數量和收入將持續增長。隨著我們建立全球市場,我們也在擴大對副甲狀腺功能減退患者的服務範圍。我們正在進行 PaTHway60 試驗,以支持在美國使用劑量高達 60 微克的 YORVIPATH。

  • We plan to begin a clinical trial for people under 18 this quarter, and we are advancing our new once-weekly TransCon PTH product candidate, which we believe would be an attractive option for patients on stable doses of YORVIPATH. In the new year, we will share more on our plans to maximize YORVIPATH value and reach even more patients. Let us now turn to growth disorder, which today comprise of our once-weekly growth hormone SKYTROFA approved for growth hormone deficiency and our once-weekly TransCon CNP currently under review by FDA in the US and by EMEA and EU for children with achondroplasia.

    我們計劃在本季度開始對 18 歲以下人群進行臨床試驗,並且我們正在推進我們新的每週一次的 TransCon PTH 產品候選藥物,我們認為對於服用穩定劑量 YORVIPATH 的患者來說,這將是一個有吸引力的選擇。在新的一年裡,我們將分享更多關於如何最大限度地發揮 YORVIPATH 的價值並惠及更多患者的計劃。現在讓我們轉向生長障礙,目前包括我們每週一次的生長激素 SKYTROFA(已獲批准用於治療生長激素缺乏症)和我們每週一次的 TransCon CNP(目前正在接受美國 FDA 和 EMEA 及歐盟的審查,用於治療兒童軟骨發育不全)。

  • SKYTROFA is approved in the US and EU for treatment of pediatric growth hormone deficiency. With this single indication, SKYTROFA is established as a high-value brand and treatment of choice for pediatric growth hormone deficiency. Q3 revenue for SKYTROFA was EUR51 million. In July, we received our first label expansion with FDA approval for adult growth hormone deficiency, the first of multiple planned label expansion. In Q3, we initiated our Phase III basket trial of SKYTROFA with a range of established growth disorder, including ISS, SHOX deficiency, Turner syndrome and SGA.

    SKYTROFA 已在美國和歐盟獲準用於治療兒童生長激素缺乏症。僅憑此適應症,SKYTROFA 就確立了其作為高價值品牌的地位,並成為治療兒童生長激素缺乏症的首選藥物。SKYTROFA 第三季營收為 5,100 萬歐元。7 月,我們獲得了 FDA 批准,首次擴大了成人生長激素缺乏症的標籤範圍,這是我們計劃擴大的多個標籤範圍中的第一個。第三季度,我們啟動了 SKYTROFA 的 III 期籃式試驗,該試驗針對一系列已確診的生長障礙,包括 ISS、SHOX 缺乏症、特納氏症和 SGA。

  • Turning to TransCon CNP. We recently completed a late cycle meeting with the FDA and are in the final stage of the label discussion. TransCon CNP is under priority review in the US with a PDUFA date of November 30 and is also under review in the EU, where our MAA filing was validated. TransCon CNP once weekly is well positioned to become the leading treatment for children with achondroplasia with the full degree of linear growth outcome that can be achieved with monotherapies addressing the overactive tyrosine three kinase.

    轉向 TransCon CNP。我們最近與FDA完成了後期週期會議,目前正處於標籤討論的最後階段。TransCon CNP 在美國正處於優先審查階段,PDUFA 日期為 11 月 30 日,同時也在歐盟接受審查,我們的 MAA 申請已在歐盟獲得批准。每週一次的 TransCon CNP 預計將成為治療軟骨發育不全患兒的領先療法,其線性生長效果可與針對過度活躍的酪胺酸激酶的單一療法完全媲美。

  • In addition, TransCon CNP achieved statistical improvement in leg bowing compared to placebo, increasing spinal canal dimension, a safety and tolerability profile compared to placebo with a very low rate of injection site reaction and no cases of symptomatic hypotension. We are confident in TransCon CNP's ability to be a leading therapy. While we believe TransCon CNP monotherapy is transformative by itself, we want to further enhance outcome for people living with achondroplasia. Earlier this year, we presented 26-week results from the Phase II COACH trial of TransCon CNP in combination with TransCon Growth Hormone, which showed around 3 times improved linear growth compared to what had been observed with monotherapies over the same time period.

    此外,與安慰劑相比,TransCon CNP 在腿部彎曲方面取得了統計學上的改善,增加了脊髓腔的尺寸,與安慰劑相比,其安全性和耐受性良好,注射部位反應發生率極低,且無症狀性低血壓病例。我們對TransCon CNP成為領先療法的能力充滿信心。雖然我們相信 TransCon CNP 單藥療法本身就具有變革性,但我們希望進一步改善軟骨發育不全患者的治療效果。今年早些時候,我們公佈了 TransCon CNP 與 TransCon 生長激素聯合治療的 II 期 COACH 試驗的 26 週結果,結果顯示,與同期單藥治療相比,線性生長提高了約 3 倍。

  • This resulted in healthy linear growth in children with achondroplasia, higher than that observed with an average state of children, accommodated by improvement in body proportionality and beat out acceleration of bone age. This data has been recognized by key opinion leaders as groundbreaking. Based on this data, we believe over time, the standard of care in achondroplasia will include combination therapy as a treatment option, building on the potential role of TransCon CNP as the backbone therapy.

    這使得患有軟骨發育不全的兒童能夠健康地線性生長,其生長速度高於正常兒童,這是透過改善身體比例和加快骨齡來實現的。這些數據已被主要意見領袖公認為具有突破性意義。根據這些數據,我們相信,隨著時間的推移,軟骨發育不全的標準治療方案將包括聯合療法,以 TransCon CNP 作為基礎療法的潛在作用為基礎。

  • Following our recent FDA end of Phase II meeting related to our combination therapy, we plan to initiate a Phase III trial this quarter. We anticipate disclosing 52-week data from the COACH trial in early 2026. With once-weekly growth hormone and once-weekly CNP, 2 highly differentiated medicines, both as monotherapy and in combination, we believe Ascendis is well positioned to become the global leader in many different growth disorders. Our Vision 2030 also includes creating value through partnership.

    繼我們最近與 FDA 就我們的聯合療法舉行的 II 期臨床試驗結束會議之後,我們計劃在本季度啟動 III 期臨床試驗。我們預計 2026 年初公佈 COACH 試驗的 52 週數據。憑藉每週一次的生長激素和每週一次的 CNP,這兩種高度差異化的藥物,無論是作為單一療法還是聯合療法,我們相信 Ascendis 都處於有利地位,有望成為許多不同生長障礙領域的全球領導者。我們的2030願景也包括透過合作創造價值。

  • And we see that being achieved through the rapid progress of Teijin in Japan, VISEN in China, Eyconis in ophthalmology and Novo Nordisk in metabolic and cardiovascular diseases, where the once-monthly semaglutide program is making fast progress towards the clinic. And finally, the commercial success of YORVIPATH and SKYTROFA has already transformed the financial profile of Ascendis. In the third quarter, we achieved positive operating income along with positive cash flow. For the near term, the building out of our commercial organization is largely completed in advance of future global launches.

    我們看到,日本帝人製藥、中國維森製藥、眼科領域的愛康製藥以及代謝和心血管疾病領域的諾和諾德製藥都取得了快速進展,實現了這一目標。其中,每月一次的司美格魯肽治療方案正在快速推進臨床應用。最後,YORVIPATH 和 SKYTROFA 的商業成功已經改變了 Ascendis 的財務狀況。第三季度,我們實現了正的營業收入和正的現金流。就近期而言,我們的商業組織建設已基本完成,為未來的全球發布做好了準備。

  • For the medium term, label expansion, LCM activities have been initiated to maximize the value of our current products. At the same time, for long-term sustainability, our R&D organization continues to advance the TransCon technology platform to ensure a constant flow of new programs and potential new products. In summary, with TransCon CNP nearing potential approval, Ascendis is well positioned to get approval of its third TransCon-based product in a row. This highlights the uniqueness of Ascendis.

    從中長期來看,我們已啟動標籤擴展和生命週期管理活動,以最大限度地提高我們現有產品的價值。同時,為了長期永續發展,我們的研發機構不斷推動 TransCon 技術平台的發展,以確保不斷湧現新的專案和潛在的新產品。總之,隨著 TransCon CNP 即將獲得潛在批准,Ascendis 預計將連續第三款基於 TransCon 的產品獲得批准。這凸顯了Ascendis的獨特性。

  • The continuous development of highly differentiated product created by the TransCon technology platform and our unique low-risk drug development algorithm. Importantly, our current three rare disease endocrine products position us for doable future growth and give us confidence in our aspiration to achieve EUR5 billion or more in annual product revenue in 2030.

    TransCon 技術平台和我們獨特的低風險藥物開發演算法,不斷開發出高度差異化的產品。重要的是,我們目前擁有的三款罕見疾病內分泌產品為我們未來的成長奠定了基礎,並使我們有信心在 2030 年實現 50 億歐元或以上的年產品收入。

  • I will now turn it over to Scott.

    現在我將把任務交給史考特。

  • Scott Smith - Chief Financial Officer, Executive Vice President, Member of the Executive Board

    Scott Smith - Chief Financial Officer, Executive Vice President, Member of the Executive Board

  • Thank you, Jan. I would like to reiterate Jan's comments that the positive operating income development seen in Q3 signals the transformation of our financial profile with sustained revenue and cash flow growth. With that, I will touch on some key points surrounding our third quarter financial results and outlook. But for further details, please refer to our Form 6-K filed today. In Q3, YORVIPATH global revenue grew to EUR143.1 million, up from EUR103 million in Q2, with strong growth partially offset by a EUR3.6 million foreign currency headwind compared to the previous quarter.

    謝謝 Jan。我想重申 Jan 的觀點,即第三季積極​​的營業收入發展標誌著我們財務狀況的轉變,收入和現金流持續成長。接下來,我將重點談談我們第三季的財務表現和展望。但更多詳情請參閱我們今天提交的 6-K 表格。第三季度,YORVIPATH 全球營收成長至 1.431 億歐元,高於第二季的 1.03 億歐元,強勁成長被與上一季相比 360 萬歐元的外匯不利因素部分抵銷。

  • In Q3 2025, SKYTROFA contributed EUR50.7 million with 3% growth in demand, offset by a EUR1.6 million foreign currency headwind compared to the previous quarter. Including EUR20 million in collaboration revenue driven by a EUR13 million milestone related to YORVIPATH and increased partner activity, total Q3 2025 revenue amounted to EUR214 million. Continuing on to expenses. R&D costs in Q3 were EUR66.9 million, down from EUR73.5 million in Q3 2024, primarily driven by completion of certain clinical trials and development activities.

    2025 年第三季度,SKYTROFA 貢獻了 5,070 萬歐元,需求增加了 3%,但與上一季相比,外匯匯率不利因素抵消了 160 萬歐元。包括 YORVIPATH 相關的 1,300 萬歐元里程碑付款和合作夥伴活動增加而帶來的 2,000 萬歐元合作收入,2025 年第三季總收入達到 2.14 億歐元。接下來是費用部分。第三季研發成本為 6,690 萬歐元,低於 2024 年第三季的 7,350 萬歐元,主要原因是某些臨床試驗和開發活動的完成。

  • SG&A expenses rose to EUR113.4 million in Q3 2025 compared to EUR69.8 million in the same period last year, reflecting continued impact of global commercial expansion. Total operating expenses for Q3 2025 were EUR180 million and operating profit for Q3 2025 was EUR11 million. Net finance expense for the third quarter of 2025 was EUR60.9 million, primarily driven by noncash items, including noncash remeasurement loss of financial liabilities of EUR47.2 million. Net cash financial income over this period amounted to EUR400,000. Note that in our 6-K filed this evening, we provide more detail on the components of finance income and expenses.

    2025 年第三季銷售、一般及行政費用增至 1.134 億歐元,而去年同期為 6,980 萬歐元,反映出全球商業擴張的持續影響。2025 年第三季總營運支出為 1.8 億歐元,2025 年第三季營運利潤為 1,100 萬歐元。2025 年第三季淨財務費用為 6,090 萬歐元,主要受非現金項目影響,包括金融負債非現金重估損失 4,720 萬歐元。在此期間,淨現金財務收入為 40 萬歐元。請注意,在我們今晚提交的 6-K 文件中,我們提供了有關財務收入和支出組成部分的更多詳細資訊。

  • In future periods, we plan to introduce a non-IFRS EPS measure adjusting for the impact of certain noncash nonoperating items, including related to our convertible notes. This is intended to increase comparability of period-to-period results. Finally, we ended the third quarter of 2025 with EUR539 million in cash and cash equivalents, up from EUR494 million at the end of Q2. Turning to our commercial outlook, primarily driven by the ongoing global launch of YORVIPATH, we expect continued revenue growth in the fourth quarter.

    未來,我們計劃引入非 IFRS EPS 指標,以調整某些非現金非經營性項目(包括與我們的可轉換票據相關的項目)的影響。此舉旨在提高各時期業績的可比較性。最後,截至 2025 年第三季末,我們的現金及現金等價物為 5.39 億歐元,高於第二季末的 4.94 億歐元。展望商業前景,主要得益於 YORVIPATH 的全球持續上市,我們預計第四季營收將持續成長。

  • For YORVIPATH specifically, we expect continued growth driven by new patients, stable pricing, payer mix and contracting in Q4. Longer term, we expect YORVIPATH to be driven by continued growth in new patients on therapy, including expansion into additional markets. For SKYTROFA, we believe that sequential revenue growth should continue to track growth in prescriptions with stable pricing, payer mix and no changes in contracting with offsets potentially driven by currency as we saw in Q3. Longer term, we expect growth for SKYTROFA to be driven by geographic and label expansion.

    具體到 YORVIPATH,我們預計第四季度在新增患者、穩定定價、付款方組合和合約簽訂的推動下,將繼續保持成長。從長遠來看,我們預計 YORVIPATH 的發展將得益於接受治療的新患者的持續成長,包括向其他市場的擴張。對於 SKYTROFA,我們認為,在價格穩定、支付方組合穩定且合約沒有變化的情況下,其收入的連續增長應繼續與處方量的增長保持一致,但匯率波動可能會像我們在第三季度看到的那樣造成抵消。從長遠來看,我們預計 SKYTROFA 的成長將由地理擴張和品牌擴張推動。

  • With that, operator, we are now ready to take questions.

    操作員,現在我們可以開始回答問題了。

  • Operator

    Operator

  • (Operator Instructions)

    (操作說明)

  • Jess Fye, JPMorgan.

    傑西費伊,摩根大通。

  • Jessica Fye - Analyst

    Jessica Fye - Analyst

  • Hey guys, good afternoon. Thanks so much for taking my question. I was hoping you could speak to your expectations for the rate of new patient enrollments on YORVIPATH in the US from here. I think you talked about more than 4,250 as of the end of 3Q, putting you at -- what is that, about 1,150 adds or maybe a little more relative to June 30. Can we think of that as kind of like a good number to work off of from here? Should it continue to kind of drift lower a little bit? Just hoping you can frame some expectations there.

    各位,下午好。非常感謝您回答我的問題。我希望您能談談您對 YORVIPATH 在美國新患者註冊率的預期。我認為你提到截至第三季末新增用戶超過 4,250 人,這意味著——那大概是 1,150 人左右,或者相對於 6 月 30 日可能略多一些。我們可以把這個數字看成一個可以當作後續工作的參考值嗎?它是否應該繼續小幅下跌?只是希望你能在那方面設定一些期望。

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Thanks, Jes. First of all, we see really a stable number of prescriptions being written in the US when we some way take away the bonus that we have from the ERP program about the 200-plus patients we have in the ERP program. When we think about Q3, I'm actually pretty surprised positively about Q3 because I was fair that prescription will be written in the three weeks any physician typically take out of their quarter in that time. And what I saw, we saw nearly the same number of prescriptions being written that we actually have seen in Q1 and Q2.

    謝謝你,傑斯。首先,當我們以某種方式扣除 ERP 計劃帶來的額外收入(該計劃涵蓋 200 多名患者)時,我們看到美國處方數量的穩定增長。當我們考慮第三季時,我其實對第三季的情況感到非常驚喜,因為我原本以為處方會在醫生通常會從季度中抽出的三週時間內開出來。我看到的是,我們看到的處方數量幾乎與第一季和第二季實際開出的處方數量相同。

  • And it's also following up with what we said in the October month. We saw more than 400 prescriptions being written in October, unique prescriptions being written in October. So when I look at this launch, look in the US, I see a very, very stable launch. And what we're also doing, we're building a fundament like a strong, strong fundament because patients stay on lifelong treatment. And therefore, when you start a patient, it basically is continued quarter-by-quarter. So it's building a house where you have a strong fundament, taking one brick on around every quarter and the house getting taller and taller every, every quarter.

    這也與我們十月所說的內容相呼應。10 月我們看到開了 400 多張處方,而且都是獨一無二的處方。所以當我觀察這次發布,尤其是在美國的發佈時,我看到的是一個非常非常穩定的發布。我們正在做的,是建立一個非常非常堅實的基礎,因為病人需要終身接受治療。因此,當你開始治療一名病人時,基本上是按季度繼續進行的。這就好比蓋房子,打好堅實的基礎,每季砌一塊磚,房子就越來越高。

  • Operator

    Operator

  • Tazeen Ahmad, Bank of America.

    塔津·艾哈邁德,美國銀行。

  • Tazeen Ahmad - Analyst

    Tazeen Ahmad - Analyst

  • Hi, good evening guys. Thanks for taking my questions. I just wanted to get a sense of how you're thinking about the rest of this quarter. Are you expecting to see impact from seasonality, I guess, we can call it just because of the upcoming holidays, Thanksgiving, Christmas and New Year's? And do you think that the script trends for December would be directionally lower, let's say, than what you're seeing what you saw for October? And then if I could ask about the TransCon CNP review. You said you're in final labeling discussions, which is good to hear. Can you just confirm whether or not you've had any requests for any type of data from the agency in the review cycle?

    大家好,晚上好。謝謝您回答我的問題。我只是想了解一下你對本季剩餘時間的計劃。您是否預計會受到季節性因素的影響?我想,我們可以這樣稱呼它,因為即將到來的節日,像是感恩節、聖誕節和新年?你認為12月份的劇本趨勢會比10月的趨勢略低嗎?然後,可以問一下關於TransCon CNP的評測嗎?你說你們正在進行最後的標籤確定討論,這真是個好消息。請您確認一下,在審查週期內,該機構是否曾向您索取任何類型的資料?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Let me take the last question. Thanks, Tazeen, first. But let me take the last question first because it's an easy one because that's no. Just no, no, no. So it's really simple. So going to the next one, it's to more of what Scott was looking, he didn't read the FLS this time, chat FLS this time. But when I'm looking forward in the future, yes, there is some holidays come up.

    讓我來回答最後一個問題。首先感謝塔津。但讓我先回答最後一個問題,因為這個問題很簡單,答案是否定的。絕對不行,不行,不行。就這麼簡單。接下來,這更符合 Scott 的預期,他這次沒有看 FLS,而是聊了聊 FLS。但展望未來時,是的,會有一些假期。

  • But when I look back, I was more worried about Q3 actually compared to the Q4 because I actually believe that there's a longer summer vacation than in Q3 compared to basically what you will see in Q4. So I see pretty positive on Q4. I see we actually increasing our prescription basis for physician writing prescription with more than 500 new prescribers, meaning is that having a broader, broader boat where there's more and more that can come in growing on the ship. And this is where I feel pretty confident about it. So no worry from my side, Tazeen.

    但回想起來,我其實更擔心第三季而不是第四季度,因為我認為第三季的暑假比第四季要長。所以我對第四季的前景相當樂觀。我看到我們實際上增加了醫生開處方的人數,新增了 500 多名處方醫生,這意味著我們的規模越來越大,可以容納更多的人加入進來,共同成長。而我對此相當有信心。所以塔津,我這邊不用擔心。

  • Tazeen Ahmad - Analyst

    Tazeen Ahmad - Analyst

  • Okay thanks yeah.

    好的,謝謝。

  • Operator

    Operator

  • Gavin Clark-Gartner, Evercore ISI.

    Gavin Clark-Gartner,Evercore ISI。

  • Tazeen Ahmad - Analyst

    Tazeen Ahmad - Analyst

  • Hey guys, thanks for taking the questions. I wanted to focus in on the conversion rate for your path. I wanted to focus in on the conversion rate for YORVIPATH. I'm wondering why it's only 70%. And you noted that you expect it to be higher over time. How much higher do you expect it to be? And when do you think it will be higher? Just had a follow-up on this, too.

    各位好,感謝你們回答問題。我想重點關註一下您路徑的轉換率。我想專注於 YORVIPATH 的轉換率。我想知道為什麼只有70%。你也提到,你預計隨著時間的推移,這個數字還會上升。你預計它會高出多少?你認為什麼時候價格會比較高?我也剛收到關於此事的後續回饋。

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Yeah. This is a question we have gotten multiple times every quarter. And what we have said in the previous quarter, we expect that it's going to be maturing over time, and it will go higher than that. And that is typical what we have seen in launches. And I actually had a long discussion with Jay about it today. And what is when we see as mature brand? Is that 85% or is it 90%? Or what is really for the mature brand that you basic -- some way are ending up at that time. And I think from a modeling perspective is that we feel extremely well where we are today. We still have taken into consideration. We're getting the patients, we're getting not only the prescription done, we're also getting the approvals done, and we're getting it done in speed.

    是的。這是我們每季都會多次被問到的問題。正如我們在上一季所說,我們預計隨著時間的推移,它會逐漸成熟,並且會高於目前的水平。這是我們在產品發表會上經常看到的現象。今天我和傑伊就此事進行了長時間的討論。那麼,我們要如何定義一個成熟的品牌呢?是85%還是90%?或者說,對於成熟的品牌而言,你最基本的是什麼——在某種程度上,最終都會達到那個程度。從建模的角度來看,我認為我們目前的狀態非常好。我們仍然考慮到了這一點。我們不僅能招募病人,還能完成處方,還能完成審批,而且速度很快。

  • And as Scott also put emphasis on this, we don't expect anything changing in the contracting environment in Q4. So we -- some expect the same detail for this product that we are seeing in both Q1, Q2 and here in Q3 and no changes to it. But Jay, you can also take a little bit of our discussion about the future about what is really for a mature brand is that where we are today. And also, we see a much higher number for SKYTROFA after it got matured.

    正如斯科特也強調的那樣,我們預計第四季度合約環境不會發生任何變化。因此,我們——有些人——希望這款產品的細節能與我們在第一季、第二季以及現在的第三季看到的相同,並且不會有任何變化。但 Jay,你也可以從我們關於未來的討論中汲取一些經驗,了解一個成熟品牌真正需要的是什麼,那就是我們今天所處的位置。而且,我們看到 SKYTROFA 在成熟後數量也高得多。

  • Jay Wu - Executive VP & President of Ascendis US

    Jay Wu - Executive VP & President of Ascendis US

  • Yeah. Thank you for the question. As mentioned before, we're really encouraged about the 70% approval rate that we're seeing now. It's actually about what we expected or guessed at the beginning of the year, just based on what we know about the clinical value proposition of the drug, which again is incredibly positive and has been resonating with a lot of the payer accounts for which we are speaking with.

    是的。謝謝你的提問。如前所述,我們對目前70%的審批通過率感到非常鼓舞。實際上,這與我們年初的預期或猜測基本一致,這完全基於我們對該藥物臨床價值主張的了解,而該藥物的臨床價值主張非常積極,並且引起了我們正在洽談的許多支付方的共鳴。

  • To answer your question, Gavin, directly in terms of what that peak approval rate could be and at what time frame, that's really hard to say, right? When you look at some of the analogs for similar drugs, that could, in some instances, take multiple years. And the reality is once you get to a certain high percentage, the remaining becomes a little bit more difficult simply just given the heterogeneous landscape of the payers, right?

    加文,要直接回答你的問題,即最高批准率可能是多少以及在什麼時間段內,這真的很難說,對吧?當你查看一些類似藥物的類似物時,你會發現,在某些情況下,這可能需要數年時間。而現實情況是,一旦達到一定較高的比例,剩下的部分就會變得更加困難,這僅僅是因為支付方的異質性,對吧?

  • It becomes quite fragmented. A lot of the government payers might review it on different timetables. So we are meeting a lot of those timetables where they're at. And again, we're continuing to talk about the incredible positive clinical value proposition that we're seeing. And that alone is resonating with a lot of them, which is why we continue to see that approval rate go up over time.

    它變得相當分散。許多政府付款方可能會按照不同的時間表進行審核。所以,我們基本上都能準時完成他們設定的時間表。我們再次強調,我們所看到的臨床價值令人難以置信。僅此一點就引起了很多人的共鳴,這就是為什麼我們看到批准率隨著時間的推移而不斷上升的原因。

  • Gavin Clark-Gartner - Analyst

    Gavin Clark-Gartner - Analyst

  • That is super helpful. And if I could just ask a like specific follow-up on that. Like for the 4,250 forms reported through the end of this quarter, are you guys basically saying you expect the conversion on this to be 70% and then trending higher for everything you just laid out after that?

    這太有幫助了。如果可以的話,我想問一個更具體的後續問題。例如,對於本季末報告的 4,250 份表格,你們基本上是說,你們預期轉換率將達到 70%,然後你們剛才提到的所有後續轉換率都會上升?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • No, it is not what we're saying, Gavin. Because if we go back and look on the early cohort, meaning it's cohort from March, April, it's much, much higher than the 70%. So this is what you see your longer time it takes, you more and more be getting approved. And that is basically the element. And this is the question we have, can we really take this tail and shorten down the tail. So we're basically getting the higher percentage that we see from the cohort we had in the beginning of the year, which are much higher than the 70%, can we start that to get it in a shorter time frame.

    不,加文,我們不是那個意思。因為如果我們回顧早期隊列,也就是三月、四月的隊列,就會發現這個比例遠高於 70%。所以你會發現,花費的時間越長,獲得批准的幾率就越大。這就是基本要素。我們現在的問題是,我們真的能把這條尾巴剪短嗎?所以,我們基本上是想達到年初那批學生的較高比例(遠高於 70%),我們能否在更短的時間內實現這個目標?

  • Gavin Clark-Gartner - Analyst

    Gavin Clark-Gartner - Analyst

  • Okay. Like the point I'm trying to get at is, for a lot of the start form -- like let's take this 3,100, you had at the end of June, maybe you've had close to 70% conversion, but the rest of the 30% is not really lost at this point. Some more still may come through as conversion. It's just a matter of time.

    好的。我想表達的觀點是,對於許多初始形式——例如,假設你在 6 月底有 3100 個客戶,也許轉換率接近 70%,但剩下的 30% 的客戶在這個時候並沒有真正流失。可能還會有一些轉入。這只是時間問題。

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Exactly. So if you take, for example, going to the cohort from March, April, much higher. If you take the earlier state cohort now that is near this month we have, it is lower than that. So this is how you see it. It's only a question about timing.

    確切地。例如,如果你看看三月、四月那一批學生,他們的水平要高得多。如果你看看本月早些時候的州級隊列,你會發現它比這要低。這就是你的看法。這只是時機問題。

  • Gavin Clark-Gartner - Analyst

    Gavin Clark-Gartner - Analyst

  • Very helpful, thanks so much.

    非常有用,非常感謝。

  • Operator

    Operator

  • Joseph Schwartz, Leerink Partners.

    Joseph Schwartz,Leerink Partners。

  • Joseph Schwartz - Analyst

    Joseph Schwartz - Analyst

  • Great, thanks very much. A question on YORVIPATH and then on TransCon CNP. Can you give us your latest views on how YORVI has been penetrating the different segments of the hypopara market as you see it? Where has it been getting the most traction? And where could it do better? And then you previously emphasized the desire to do more than enhance linear growth in achondroplasia. So I'm wondering to what extent do you think you can obtain differentiated label claims on the TransCon CNP label?

    太好了,非常感謝。先問一個關於 YORVIPATH 的問題,然後問一個關於 TransCon CNP 的問題。您能否談談您對YORVI如何滲透到副妊娠高血壓市場不同細分領域的最新看法?它在哪裡最受歡迎?還有哪些方面可以做得更好?而且您之前也強調過,希望在軟骨發育不全方面,不僅僅是促進線性生長。所以我想知道,您認為在 TransCon CNP 標籤上可以獲得差異化標籤聲明的程度如何?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Let me take the last question. As I said in the prepared remarks, we are in the late-stage discussion about the labeling. And I cannot really comment about what will really be in the final labeling in this perspective. What is really the key element for me in my discussion with patients and my discussion with physician, Aimee Shu's discussion, our medical affair discussion with the teams is really to explain the benefit they see behind the growth. And it's clear, unique effect in leg bowing, unique effect in changing body proportionality.

    讓我來回答最後一個問題。正如我在準備好的發言稿中所說,我們目前正處於標籤問題的討論後期階段。我無法就最終的標籤內容發表任何評論。在我與病人、醫生、Aimee Shu 以及我們醫療事務團隊的討論中,對我來說,真正的關鍵在於解釋他們所看到的成長背後的益處。而且,它在矯正腿部彎曲方面有獨特的效果,在改變身體比例方面也有獨特的效果。

  • And we will have peer-review publication really supporting all this claim that will come out, really give us an opportunity to take and talk with the patient, talk with the physician about this benefit in it. I think this is the key thing for me. We -- I saw and -- we saw an element once with hypopara where basic it was impossible for getting into the labeling our element of patient benefit related to cognitive function, other quality of life and everything like that and everyone recognize it. Everyone see it, anything see that is the best thing. I think that's the key thing from our labeling discussion is have no restrictions, have a really safe product, really show our efficacy and safety in the best possible manner in this way. Jay, will you take the first part of the question in this one to Joe?

    我們將有同行評審的出版物來真正支持所有這些說法,這將給我們一個機會,讓我們能夠與患者、與醫生討論其中的益處。我認為這對我來說至關重要。我們——我看到——我們曾經在低血壓症中看到過一個因素,其中根本無法將我們患者的獲益因素與認知功能、其他生活品質等等聯繫起來,每個人都認識到這一點。大家都看到了,能看到的東西就是最好的。我認為我們標籤討論的關鍵在於不要有任何限制,要有一個真正安全的產品,要以最佳方式真正展現我們的功效和安全性。傑伊,你能把這個問題的第一部分轉告給喬嗎?

  • Jay Wu - Executive VP & President of Ascendis US

    Jay Wu - Executive VP & President of Ascendis US

  • Yeah, could we repeat -- can we repeat the first part of that question?

    是的,我們能重複一下——我們能重複一下那個問題的第一部分嗎?

  • Joseph Schwartz - Analyst

    Joseph Schwartz - Analyst

  • Yeah, sure. I was just wondering, you've outlined the different segments of the market based on how controlled the patients are. So I was wondering, how are you making inroads into those segments lately? Where are you getting the most traction? And where could you do better?

    當然可以。我只是想問一下,您已經根據患者的病情控製程度劃分了不同的市場區隔。所以我想知道,你們最近是如何打入這些細分市場的?你在哪裡獲得了最大的迴響?還有哪些方面可以做得更好?

  • Jay Wu - Executive VP & President of Ascendis US

    Jay Wu - Executive VP & President of Ascendis US

  • Yeah. So when you think about the 80,000, 90,000 patients that Jan had referenced earlier in the call, I think there's probably a group that we would describe as highly symptomatic, patients are well aware of their symptoms, articulating those symptoms to a physician and within those, I would say we're doing quite well, particularly since the patients themselves are likely the ones that are in the offices most frequently and are keeping the appointments on the books to be able to essentially get some of that information and also be on their way to actually get prescribed the products.

    是的。所以,想想 Jan 在電話會議中提到的 8 萬、9 萬名患者,我認為其中可能有一部分患者症狀非常嚴重,他們很清楚自己的症狀,能夠向醫生描述這些症狀。在這些患者中,我認為我們做得相當不錯,特別是考慮到患者本身可能就是最常來診所就診、按時預約的人群,這樣他們才能獲得一些信息,並最終獲得處方藥。

  • I think where we're continuing to work on are some of the patients for which maybe they're not either self-identifying some of their symptoms as being related to the underlying condition and/or perhaps they've gotten used to some elements of it and therefore, haven't been as motivated to establish care and retain established care with a specialist. And I think that's why as we think about how we can continue to transform this market, there will be an element of patient activation as well simply because there is going to be a certain level of disease education required, particularly for a space like this where it is about redefining what's possible and kind of the status quo for how to manage this type of condition.

    我認為我們目前仍在努力幫助的一些患者,可能他們沒有意識到自己的某些症狀與潛在疾病有關,或者他們可能已經習慣了疾病的某些方面,因此沒有那麼大的動力去尋求專科醫生的幫助並維持現有的治療。我認為這就是為什麼當我們思考如何繼續改變這個市場時,也需要加入患者賦能的元素,因為這需要一定程度的疾病教育,尤其是在像這樣的領域,我們需要重新定義什麼是可能的,以及如何管理這類疾病的現狀。

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Yeah. If I can add something, Jay. I see it from 2 different perspectives. How often you come into the endo. This is one way. It is how we target it and define something that is not defined on medical terms, but only on how often you see an endo related to being controlled, partly controlled or -- and what I'm also trying to look at -- I try to look on where are they coming? Are they coming from the post surgery? Are they coming from the genetic part? Are they coming from the immunological part? I see them coming from everywhere. So for example...

    是的。傑伊,如果我能補充一點的話。我從兩個不同的角度來看這個問題。你多久來一次內視鏡檢查?這是其中一種方法。關鍵在於我們如何針對它,並定義一些無法用醫學術語定義的東西,而只能根據你看到內分泌失調與控制、部分控製或——這也是我試圖了解的——它們來自哪裡來的情況來定義。這些症狀是術後出現的嗎?它們是否來自基因部分?它們是否來自免疫系統?我看見他們從四面八方湧來。例如…

  • Operator

    Operator

  • Again, please stand by the conference call. We'll begin to resume momentarily. Please continue.

    請大家繼續保持電話會議的進行。我們將很快恢復。請繼續。

  • Jay Wu - Executive VP & President of Ascendis US

    Jay Wu - Executive VP & President of Ascendis US

  • Where did you last hear us at? I think this was Joe, your question about the...

    你上次在哪裡聽到我們的消息?我想這是喬問的,關於……的問題。

  • Joseph Schwartz - Analyst

    Joseph Schwartz - Analyst

  • Yeah. welcome back. So I guess, I was wondering about your progress within the different levels of control and where you can do better and just how you've been able to penetrate patients in each of these segments.

    是的,歡迎回來。所以,我想知道您在不同控制級別方面的進展,以及您在哪些方面可以做得更好,還有您是如何在每個細分市場中成功打入患者的。

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Yeah. I think, Jay, at least I heard Jay's response to it. And my additional comments was that when we did the targeting of our physician, we made it out from the claims database where we defined three groups: controlled, partly controlled and incontrolled. It's nothing to do with medical terms, but basic is a acceleration, how we basically are looking on the patients seeing a physician. So what I'm also looking is, do we see all patient group in our patient being coming on YORVIPATH's treatment.

    是的。我想,傑伊,至少我聽到了傑伊對此的回應。我的補充意見是,當我們對醫生進行定位時,我們從索賠資料庫中找到了三個組:受控組、部分受控組和未受控組。這與醫學術語無關,但基本原理是一種加速,它基本上反映了我們看待病人看醫生的方式。所以我還在觀察,我們是否看到所有患者群體都接受了 YORVIPATH 的治療。

  • And when I see that, it's pretty clear that we are in a position we see the obvious post surgery. But when we look on different element of generic, genetic or immunological, we also see all different groups of patients, even patients from the ADH1, which really, really are less than 1% in the claim database. We already have about 15 patients on treatment with this symptom, which really gave us a hope that we basically will see the same penetration everywhere in all different types of the hypopara patients in this way.

    當我看到這一點時,很明顯,我們現在處於一個可以看到術後明顯情況的位置。但當我們從通用、遺傳或免疫學等不同方面來看待問題時,我們也會看到各種不同的患者群體,甚至包括 ADH1 患者,他們在索賠資料庫中的佔比實際上不到 1%。我們已經有大約 15 名患有這種症狀的患者正在接受治療,這真的讓我們看到了希望,我們基本上可以在所有不同類型的產後低血壓患者身上看到同樣的突破。

  • Scott Smith - Chief Financial Officer, Executive Vice President, Member of the Executive Board

    Scott Smith - Chief Financial Officer, Executive Vice President, Member of the Executive Board

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Li Watsek, Cantor.

    李·瓦特塞克,坎托爾。

  • Li Wang Watsek - Analyst

    Li Wang Watsek - Analyst

  • Thank you guys, thanks for taking our questions. I guess just on can you maybe just give us a little bit color on payer mix and potential contracting, not just in Q4, but also in 2026? And should we sort of expect still minimum contracting and sort of stable gross to net for the next few quarters?

    謝謝各位,謝謝你們回答我們的問題。我想請您簡要介紹一下支付方構成和潛在合約情況,不僅是第四季度,還有 2026 年的情況?我們是否可以預期未來幾季仍將保持最低限度的合約簽訂量,並且毛利潤與淨利潤的比例將保持相對穩定?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • I think Scott more or less addressed it in his prepared remarks. There will be no changes into Q4. If we look forward, will there be potential more contracting that we have seen now and Jay can comment on it, we are in a position where contracting will not any way change dramatically our GTN in any kind of financial modeling in this perspective. And we see YORVIPATH really have all the characteristic of a product. It's a first in class. There's only one treatment option. And we see it actually being -- not only being prescribed, but also being reimbursed to the level that we have hoped for. Jay, you have further comments to the long-term perspective of contracting?

    我認為斯科特在事先準備好的發言稿中已經或多或少地談到了這一點。第四季不會有任何變化。展望未來,是否會有比現在更多的合約簽訂,Jay可以對此發表評論,從這個角度來看,合約簽訂不會以任何方式從財務模型上極大地改變我們的GTN。我們看到 YORVIPATH 確實具備所有產品應有的特質。這是同類產品中的首例。只有一種治療方案。我們看到它不僅被處方使用,而且也得到了我們所希望的報銷。Jay,你對承包的長期前景還有其他看法嗎?

  • Jay Wu - Executive VP & President of Ascendis US

    Jay Wu - Executive VP & President of Ascendis US

  • Yeah. I would just reaffirm what you shared, consistent contracting strategy in Q4, as previously discussed, given the first and only nature of what we have and the fact that the clinical value proposition speaks for itself, we don't anticipate any major contracting that's going to deviate above and beyond what we've shared before, which is more minor contracting around ensuring a frictionless patient experience. So again, nothing substantial or anything meaningful above and beyond what we've discussed to date. Any changes will be minor.

    是的。我只想重申您之前分享的內容,即第四季度的合約策略,正如之前討論過的,鑑於我們目前所擁有的獨一無二的特性,以及臨床價值主張本身就足以說明一切,我們預計不會有任何重大合約會偏離我們之前分享的內容,這些合約更多的是圍繞確保患者獲得流暢體驗而進行的較小規模的合約。所以,再說一遍,除了我們迄今為止討論的內容之外,沒有什麼實質的或有意義的進展。任何改動都將是細微的。

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • And when we look at the we can say the competitive landscape, we don't believe any of the -- what we see in the competitive landscape will really make us move into a much more highly contracted product as we see it really with the best-in-class properties compared to everything what we see.

    當我們審視競爭格局時,我們認為,我們所看到的競爭格局中的任何因素都不會真正促使我們轉向更高度緊湊的產品,因為我們看到的是一流的房產,與我們所看到的所有其他房產相比,它確實更勝一籌。

  • Li Wang Watsek - Analyst

    Li Wang Watsek - Analyst

  • And then just curious about the TransCon CNP and the Phase II meeting. In terms of the Phase III trial design, should we assume that FDA would require a 1-year data on annualized growth velocity? And anything that you can share on the powering assumptions?

    然後,我對TransCon CNP和第二階段會議感到好奇。就 III 期試驗設計而言,我們是否應該假設 FDA 會要求 1 年的年化成長速度資料?關於這些驅動因素的假設,您有什麼可以分享的嗎?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Yeah. That is an interesting question because I basically have never seen anything longer than 1-year clinical trial in any growth disorder. I've seen a lot of perception about something that could be taken up as 2 years, but I've never seen any regulatory package that have more than 1 year controlled treatment in this. We have already what we call long-term data that will be generated from our Phase II trial. So I think that is basically the element of what I never have seen for in this way. And Aimee Shu went to the FDA meeting, so she can basically just give you the view about what she basically got a feedback from that perspective.

    是的。這是一個有趣的問題,因為我基本上從未見過任何生長障礙的臨床試驗超過 1 年。我看到很多人認為某些事情可能需要兩年才能完成,但我從未見過任何監管方案規定此類受控治療超過一年。我們已經有了所謂的長期數據,這些數據將從我們的 II 期試驗中產生。所以我覺得這基本上就是我從未以這種方式見過的因素。艾米·舒參加了FDA會議,所以她基本上可以從那個角度向你傳達她得到回饋的觀點。

  • Aimee Shu, - Executive Vice President, Chief Medical Officer

    Aimee Shu, - Executive Vice President, Chief Medical Officer

  • Yeah. So Li, happy to say that we found our reviewers at FDA to be appropriately open-minded about -- appropriately clinically open-minded about duration here. But there's obviously a regulatory pathway, and that's usually 1 year of data.

    是的。所以李,很高興地說,我們發現 FDA 的審查人員對治療持續時間持適當的開放態度——在臨床上持適當的開放態度。但顯然存在監管途徑,通常需要 1 年的數據。

  • Operator

    Operator

  • Yaron Werber with TD Cowen.

    Yaron Werber 與 TD Cowen 合作。

  • Martin Auster - Analyst

    Martin Auster - Analyst

  • Great, thanks so much. Maybe, Jan, I maybe a couple of questions. Number one, just on gross to net. When we're kind of -- we were at around just over 4,200 and we had like a 65% approval, but we were getting to higher numbers for the quarter. So I'm wondering whether -- and we had 18% gross to net. Is it possible that gross to net discounts are higher than that? That wouldn't make any sense. And I guess the question kind of like what am I missing?

    太好了,非常感謝。或許,簡,我可能還有幾個問題。第一名,僅以毛毛比淨毛比計算。當我們達到——當時我們的數字剛過 4200,批准率約為 65%,但我們本季的數字正在上升。所以我想知道——我們的毛利潤率是淨利潤率的 18%。毛利折扣與淨利折扣比是否有可能高於這個數值?那根本說不通。我想問的問題是:我錯過了什麼?

  • And then maybe secondly, are you -- it sounds like you may be very subtly intimating to expect some impact from the holidays in Q4. Are we reading it correctly because we didn't see much seasonality in Q3. And then finally, U.S. versus European sales for YORVI in the quarter, was it like around EUR4 million or so in Europe this quarter as well?

    其次,你是不是——聽起來你似乎在非常委婉地暗示,預計第四季會受到假期的影響。我們解讀得對嗎?因為我們在第三季並沒有看到明顯的季節性波動。最後,YORVI本季在美國和歐洲的銷售額對比,在歐洲的銷售額是否也像本季一樣在400萬歐元左右?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Yeah. There was three questions. The element of what I will take -- what we said in the beginning of the year is still what we really have seen. We said we will expect ex-U.S. be around EUR4 million to EUR5 million increase every quarter because we have not really expanded it more to fully commercial countries, which we did now in here in Q3, but we first see the effect on that perspective in this way.

    是的。共有三個問題。我要採取的措施——我們在年初所說的,仍然是我們真正看到的。我們曾表示,預計美國以外的地區每季將增加 400 萬至 500 萬歐元,因為我們還沒有真正將其擴展到完全商業化的國家,而我們現在在第三季做到了這一點,但我們首先要從這個角度看到影響。

  • Related to the seasonality on it, I don't expect to see any seasonality in Q4. That is pretty clear. I expect it to potentially to have seen it in Q3 because I expected the physician to be gone for 3 weeks. And when we not really saw a major impact in Q3 I don't expect to see any impact in Q4. Scott, he's really the guy with the numbers and everything like that. So he really is good at that. So Scott, can you take the first question?

    至於季節性因素,我預計第四季不會出現任何季節性現象。這一點很清楚。我預計第三季可能會看到結果,因為我預計醫生會休假三週。第三季我們並沒有看到重大影響,所以我預期第四季也不會看到任何影響。史考特,他才是真正懂數據和這類事情的人。所以他在這方面確實很擅長。史考特,你能回答第一個問題嗎?

  • Scott Smith - Chief Financial Officer, Executive Vice President, Member of the Executive Board

    Scott Smith - Chief Financial Officer, Executive Vice President, Member of the Executive Board

  • Yeah. So I think your question was the 70% approvals and the time to revenue. We could probably follow up offline on how you're thinking about things. But just remember also, when there's an approval, this isn't the exact same thing as patient on drug, right? They get approved and then sometimes it's too soon and sometimes it takes a while. But that's probably the only thing to keep in mind, Yaron.

    是的。所以我覺得你的問題是關於70%的審批通過率和實現獲利所需的時間。我們可以私下聊聊你對這件事的看法。但也要記住,獲得批准並不等於病人開始服用藥物,對吧?申請獲得批准後,有時時間太早,有時則需要一段時間。但亞倫,這大概是唯一需要記住的事情了。

  • Operator

    Operator

  • Martin Auster with Raymond James.

    Martin Auster 與 Raymond James 合作。

  • Martin Auster - Analyst

    Martin Auster - Analyst

  • Hey guys, thanks for taking the question. I'll try not to be too greedy and just keep it to a couple. First, on YORVIPATH, I was wondering if you could comment if you've got any sense of early data on what patient retention looks like from folks who started up on drug this year? And then second, on TransCon CNP. I guess from a commercial perspective, when we look at this market, it looks a little underpenetrated for a rare disease market compared to some other comps. I'm curious if you guys have a sense as to sort of why that's the case? And if you think TransCon CNP is sort of coming to market can improve upon that and improve overall penetration rates of treated folks with achondroplasia?

    各位,謝謝你們回答這個問題。我會盡量克制自己的貪心,只買幾個。首先,關於 YORVIPATH,我想請問您是否了解今年開始服用該藥物的患者的患者留存率的早期數據?其次,關於 TransCon CNP。從商業角度來看,與一些其他同類市場相比,這個罕見疾病市場的滲透率似乎有點低。我很好奇你們是否知道造成這種情況的原因?如果您認為 TransCon CNP 即將上市,並且能夠改善現有產品並提高軟骨發育不全患者的整體治療普及率,那麼這種想法是否正確呢?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Thanks, Martin, for the question. The first one is really, really -- spend a lot of time on it, spend a lot on the analytical. And we are losing very, very, very few patients when they have initiated treatment. There are few percentage. And if we lose them, it's basically in the first 4 to 6 weeks, meaning is that we are now trying to go back how can we potentially help them in the titration phase. And I think that is always the element where you start on a syste,m, where you are on conventional therapy, you start to do it, you need to take it off. And I believe if there are not a good interaction between both the physician, the place where we get calcium monitoring and everything like that, it -- are a more difficult period for the time. This is why the titration.

    謝謝馬丁的提問。第一件事就是真的,真的——要花很多時間在這上面,花很多時間進行分析。而且,一旦患者開始接受治療,我們的流失率就非常非常低。比例很小。如果我們失去他們,基本上是在最初的 4 到 6 週內,這意味著我們現在正在嘗試回過頭來,看看我們怎麼能在滴定階段幫助他們。我認為,當你開始接受某種治療方案,例如傳統療法時,一旦開始治療,就需要停止治療。而且我認為,如果醫生和我們進行鈣監測等檢查的地方之間沒有良好的互動,那麼那段時間將會更加艱難。這就是滴定的原因。

  • This is why we started obviously one daily product because we know we could never get this titration to function with a once-weekly product. So that is where we see. When we see after 4 to 6 weeks when we're starting to be stable, exactly as I said here, we expect nearly all patients to be on lifelong treatment. This is like building the fundament stronger and stronger. And Martin, I agree with you. If you look on vosoritide, it's doing really poorly in the US. They're saying they're doing really good outside the U.S. I think they're doing really poorly in US. That should be much, much higher. And I believe that because they're not really addressing what they really should address are the comorbidities.

    這就是為什麼我們一開始只生產每日一次的產品,因為我們知道,如果只生產每週一次的產品,就永遠無法達到這種滴定效果。所以,這就是我們看到的。當經過 4 到 6 週後,病情開始穩定下來時,正如我剛才所說,我們預計幾乎所有患者都需要終身治療。這就像是不斷地夯實基礎。馬丁,我同意你的看法。如果你看一下沃索利肽(Vosoritide),它在美國的表現非常糟糕。他們說他們在美國以外的地區發展得非常好。但我認為他們在美國的發展非常糟糕。這個數字應該要高得多。我認為這是因為他們沒有真正解決他們真正應該解決的問題,那就是合併症。

  • And I believe this is where we come in with a differentiated product. This is why when I talk with the different patient organization groups, and really, they asked me a simple question. Jan, will you have set the primary endpoint to be linear growth if you were the first product? And I said, no, we will never have done that. We will really have addressed how we're really addressing the comorbidities because we believe that is really why patients should take that treatment, help them to the comorbidities, really help them in this way. And this is where I believe we have an extremely positive dialogue with all the patients and the patient related to that topic.

    我相信這就是我們憑藉差異化產品取勝的地方。這就是為什麼當我與不同的患者組織團體交談時,他們實際上問了我一個簡單的問題。Jan,如果你是第一個推出的產品,你會將主要終點設定為線性成長嗎?我說,不,我們絕對不會那樣做。我們將真正解決如何應對合併症的問題,因為我們相信這才是患者應該接受治療的真正原因,幫助他們應對合併症,真正以這種方式幫助他們。我認為,正是在這裡,我們與所有患者以及與該主題相關的患者進行了非常積極的對話。

  • Martin Auster - Analyst

    Martin Auster - Analyst

  • And looking for November 30.

    並期待11月30日。

  • Operator

    Operator

  • (Operator Instructions)

    (操作說明)

  • Paul Choi with Goldman Sachs.

    Paul Choi,高盛員工。

  • Yun Zhong - Analyst

    Yun Zhong - Analyst

  • Hi, good afternoon and thanks for taking the question. I also want to stay on TransCon CNP and maybe ask on the commercial strategy as you launched it and particularly for next year. Are you primarily going to target de novo patients? Or are you expecting a good portion of the revenue mix to be from CNP daily injection experienced patients? And if you are expecting a decent-sized contribution from the latter, can you maybe speak to what your market research suggests the appetite is on potential switch strategies and just sort of what percentage of the existing treated patient base you might think ultimately convert?

    您好,下午好,感謝您回答這個問題。我也想繼續關注 TransCon CNP,並詢問一下你們推出的商業策略,特別是明年的商業策略。你們的主要目標群是初診患者嗎?或者,您是否預期收入的很大一部分將來自有 CNP 每日註射經驗的患者?如果您期望後者能做出相當大的貢獻,您能否談談您的市場研究結果顯示,人們對潛在的轉換策略有何興趣,以及您認為現有接受治療的患者群體中最終會有多少比例的人會進行轉換?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Thanks for the question. Yes, we expect there to be a lot of switches. We enrolled patients in the places where vosoritide were commercially available free for the patient. We enrolled it where there was other treatment alternatives, if you call them treatment alternatives. We were in a position that we preferred it out from the perspective is that not only the once-weekly profile, but the lack of injection site reaction. Really to be in a position, you don't need to worry about any risk of hypotension and anything like that. That was really one of the key movement.

    謝謝你的提問。是的,我們預計會有很多人員流動。我們在沃索利肽可免費商業供應的地區招募病患。我們把它納入研究範圍,因為當時還有其他治療方案可供選擇,如果你能把它們稱作治療方案的話。我們當時的立場是,我們更喜歡這種方式,不僅是因為它每週只需注射一次,還因為它不會出現注射部位反應。在這種情況下,你完全不用擔心低血壓之類的風險。那確實是一次關鍵的行動。

  • And also at that time, we not even have really the clarity of beyond linear growth, the benefit beyond linear growth. So when I look today, is it going to be a last portion on switch patients when you have therapy being implemented to a high level, which it is in some European countries. In some European countries, 60%, 70% of all patients will be treated today, and there will be switching. They are just waiting for it. We know they're waiting for it because they asked for it all the time, when will it be approved in Europe. If you go to U.S., because of not high penetration, there will be many more new patients coming in because there's not too many to switch off. So this is what we see and how we will build up the commercial strategy.

    而且當時,我們甚至還沒有真正清楚地認識到超越線性成長的意義和益處。所以,當我今天觀察時,當一些歐洲國家已經實施了高水準的治療時,這是否會成為轉診病患的最後一部分?在一些歐洲國家,今天將有 60%、70% 的患者接受治療,並且將會出現轉診現象。他們正等著這一刻到來。我們知道他們一直在等待,因為他們一直在要求,它什麼時候才能在歐洲獲得批准?如果你去美國,由於市場滲透率不高,將會有更多的新病患湧入,因為沒有太多病患需要流失。這就是我們所看到的,也是我們將如何建構商業策略的。

  • Yun Zhong - Analyst

    Yun Zhong - Analyst

  • Okay, great, thank you.

    好的,太好了,謝謝。

  • Operator

    Operator

  • Yun Zhong, Wedbush.

    雲中,韋德布希。

  • Yun Zhong - Analyst

    Yun Zhong - Analyst

  • Hi, good afternoon. Thank you very much for taking the questions. So the first question on the label extension to the higher dose. I assume the pricing is going to be the same. So would you expect any direct impact on maybe the number of patients on treatment and reported revenue, please?

    您好,下午好。非常感謝您回答這些問題。所以第一個問題是關於標籤擴展至更高劑量的問題。我估計價格會一樣。那麼,您認為這會對接受治療的患者人數和報告的收入產生直接影響嗎?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • First of all, when we look on treatment in a dose larger than the 30 dose, it's only restricted to the US. And currently, when we see in many countries, there are few percentage of patients that really need it in a commercial setting. We have said there is some patients that really need it. And they are, in many cases, already on treatment in the US. By having this trial, the patient that basically will need more than 30 in the US will now have availability because they can join us in the clinical trial. The clinical trial, as Aimee can explain, is a very, very simple single-arm study. You can explain how many patients we have. It's basically a safety trial.

    首先,當我們考慮劑量大於 30 的治療時,它僅限於美國。目前,在許多國家,我們看到只有一小部分患者真正需要在商業環境下接受治療。我們說過,有些病人確實需要這種治療。而且在很多情況下,他們已經在美接受治療。透過這項試驗,原本在美國需要接受 30 多次治療的患者現在將有機會接受治療,因為他們可以加入我們的臨床試驗。正如艾米所解釋的那樣,這項臨床試驗是一項非常非常簡單的單臂研究。你可以解釋一下我們有多少病人。這基本上是一次安全性試驗。

  • Aimee Shu, - Executive Vice President, Chief Medical Officer

    Aimee Shu, - Executive Vice President, Chief Medical Officer

  • Yeah. So single arm is going to be 18 subjects who will be titrated as they need based on serum calcium using the higher doses.

    是的。因此,單臂試驗將納入 18 名受試者,根據血清鈣水平,使用較高劑量進行劑量調整。

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • So it's basically is an 18-patient 6-month trial for a safety perspective, and that will be the triggering point to also in the US have it. I don't think it will have a material impact in any way on our revenue.

    所以,這基本上是一項針對 18 名患者、為期 6 個月的安全試驗,這將是美國也進行這項試驗的觸發點。我認為這不會對我們的收入產生任何實質影響。

  • Yun Zhong - Analyst

    Yun Zhong - Analyst

  • Thank you for the clarification. Then a follow-up question on the payer discussion. I believe that initially, you said roughly it takes about eight weeks to get payer approval then I think last quarter, you said three months. And then this quarter, just now, you probably said 8 months. Was that just a random maybe fluctuation? Or was there any meaningful change in terms of how long it takes for payers to approve coverage, please?

    謝謝你的解釋。然後是關於付款方討論的後續問題。我相信你最初說過,獲得付款方批准大約需要八週時間,然後我想上個季度,你說需要三個月。然後,就本季而言,剛才你可能說的是8個月。那隻是一次隨機波動嗎?或者說,在支付方批准承保所需的時間方面,是否有任何實質性的變化?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • We see an improvement month by month. And when we looked at the data today, with about the 50% and the eight weeks, that is the data we see today.

    我們看到每個月都有進步。今天我們查看數據時,發現大約有 50% 的人在八週內達到了這個比例,這就是我們今天看到的數據。

  • Yuxi Dong - Analyst

    Yuxi Dong - Analyst

  • Okay great thank you.

    好的,非常感謝。

  • Operator

    Operator

  • Alex Thompson with Stifel.

    Alex Thompson 與 Stifel 合作。

  • Charles Ndiaye - Analyst

    Charles Ndiaye - Analyst

  • Hi, This is Charles on for Alex. Maybe a bit of a different question, but in terms of the sort of adolescent buckets of hypoparathyroid patients you're looking at, I guess, like what kind of patient size does this represent in the US? And what kind of growth do you expect to see from here, assuming there's a successful label expansion?

    大家好,我是查爾斯,替亞歷克斯報到。也許這個問題有點不同,但就你所關注的青少年甲狀旁腺功能減退症患者群體而言,我想問的是,這在美國代表著多大的患者規模?如果唱片公司成功擴張,您預期未來會有怎樣的成長?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • This patient group is a quite different patient group to compare to the pool of the patients we talk today in US and other countries. Many of these young children are coming from more the genetic and immunological part and not so much from head and neck operation. Still there can be postsurgical patients at that stage, too. These patients are in a severe case because if you have hypopara in such a young age, a lot of developmental part is really affected not to have the right calcium hemostasis, phosphate hemostasis and bone hemostasis in the body today.

    這個患者群體與我們今天在美國和其他國家談論的患者群體有很大的不同。這些幼童的病情較多是由於遺傳和免疫因素,而不是頭部和頸部手術造成的。但即便如此,仍會有術後患者處於這個階段。這些患者病情嚴重,因為如果在如此年輕的年紀就患有產後低血壓,許多發育部位都會受到影響,導致體內鈣穩態、磷酸鹽穩態和骨骼穩態失衡。

  • So I see it as really as high level of severity of disease to have it also in this extremely young age. I even have seen young people that have it from -- young that already have kidney transplantation in the 20s because of the high burden of the treatment that has been available today with conventional therapy. And when we look on the number, it will not be a number that ever can come up to the level that you see in the adult population, but it's not changing the severity of really making a treatment available for this patient group.

    所以我認為,在如此年輕的年紀就患上這種疾病,確實屬於病情非常嚴重的級別。我甚至見過一些年輕人患有這種疾病——他們在 20 多歲就接受了腎臟移植,因為目前常規療法的治療負擔很重。從數字上看,這個數字永遠不會達到成年人口的水平,但這並沒有改變為該患者群體提供治療的嚴重性。

  • Operator

    Operator

  • Luca Issi with RBC.

    Luca Issi 與 RBC。

  • Maxwell Skor - Analyst

    Maxwell Skor - Analyst

  • Thanks so much for taking my question. Maybe on the unique patient enrollment, is that a metric that you're committed to report going forward? Or are you planning to sunset that metric at some point? And if it is the latter, can you talk about whether that could be Q4 or would that be later than that? And then maybe if I can ask about Novo Nordisk, can you just talk about how that collaboration is going?

    非常感謝您回答我的問題。或許關於獨立病患註冊人數,這是你們承諾今後要報告的指標嗎?或者你們計劃在某個時候停止使用該指標?如果是後者,您能否說明一下這是否會在第四季度,還是會更晚?然後,我可以問一下關於諾和諾德的問題嗎?能談談雙方的合作進度如何嗎?

  • Obviously, lots going on at Novo, given again, new leadership in place. And obviously, we just lost the deal on Metsera. I'm wondering if you're seeing any disruption with that collaboration with them or maybe the opposite, actually an acceleration of that collaboration. So again, any thoughts there, much appreciated.

    顯然,Novo公司發生了很多事情,尤其是新的領導層已經上任。很顯然,我們失去了與Metsera的交易。我想知道你是否看到與他們的合作受到了任何干擾,或者恰恰相反,合作實際上得到了加速。所以,再次感謝大家的任何想法。

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Yeah. Let me take the last question first about our collaboration. And when I look on the collaboration, and we look on that once monthly semaglutide, which I believe have a unique profile because of the slowly release from the product system to a level where the Tmax is very late, and therefore, you don't have a high slope. So likely the tolerability as we have seen in animal model really can also be established in the clinical trials in humans in this way. As we are responsible for last element of the collaboration, there have definitely not been any disruption, and there has definitely not been any lack of interest in this program.

    是的。首先,讓我回答關於我們合作的最後一個問題。當我審視這種合作,以及我們每月一次的司美格魯肽時,我認為它具有獨特的特性,因為它從產品系統中緩慢釋放到 Tmax 非常晚的水平,因此,它的斜率並不高。因此,正如我們在動物模型中看到的那樣,耐受性很可能也可以透過這種方式在人體臨床試驗中得到證實。由於我們負責合作的最後一個環節,所以絕對沒有出現任何中斷,也絕對沒有出現對該計劃缺乏興趣的情況。

  • And this is not one single program. It's, as I said in our press release, it's a series of programs that we are working on. So we definitely have not seen any kind of lack of interest and is progressing with the speed which we can do it to in this really positive collaboration as fast as we can do. We believe that when they come to the late stage, sure, the muscle of a company like Novo Nordisk to make a large Phase III trial in multiple ways is really unique because they really have the capacity and unique level of expertise to do it. Sadly now, I forgot the first question.

    而且這並非某個單一項目。正如我在新聞稿中所說,這是我們正在進行的一系列項目。因此,我們絕對沒有看到任何缺乏興趣的情況,我們正在以最快的速度推進這項非常積極的合作。我們認為,當進入後期階段時,像諾和諾德這樣的公司確實有能力以多種方式進行大規模的 III 期試驗,這是非常獨特的,因為他們確實擁有開展這項試驗的能力和獨特的專業知識水平。可惜的是,我忘了第一個問題。

  • Scott Smith - Chief Financial Officer, Executive Vice President, Member of the Executive Board

    Scott Smith - Chief Financial Officer, Executive Vice President, Member of the Executive Board

  • Enrollment as a metric?

    以入學人數作為衡量指標?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Yeah. The enrollment as a metric is a question that we discussed a lot. And we won't comment on it. When you're feeling that we are in a position that revenue that we are reporting now really are coming to a level where you're feeling that it's really coming to a stage where the addition of new patients really are not changing so much of the overall. As I said, we're building a strong fundament quarter-by-quarter. The strong fundament is building a really tall house.

    是的。招生人數作為一項衡量指標,是我們討論了很多次的問題。我們對此不予置評。當您感覺到我們現在所報告的收入水平確實已經達到一個階段,以至於新增患者對整體情況的影響並不大時。正如我所說,我們正在逐季度地建立堅實的基礎。堅實的基礎就是建造一座高聳入雲的房子。

  • And we are now taking bricks by bricks, quarter-by-quarter, and we're building this revenue base up more and more. And you can really from just a mathematic modeling, think about it when we are much more further in the launch, the addition of new patients just are not giving the same impact on the overall actual revenue at that stage. And therefore, I believe at one time, the number of new prescription is not really meaningful for you. You will just see a quarterly revenue growth that basically are just reflecting the addition of new patients

    我們現在正一步一腳印,按季度穩步推進,不斷擴大收入基礎。僅僅透過數學建模,你就可以清楚地看到,當我們在產品上市後期,新增患者對當時的整體實際收入的影響並不相同。因此,我認為,在某個時期,新處方的數量對你來說並不具有真正的意義。你只會看到季度收入成長,這基本上只反映了新增患者的增加。

  • Operator

    Operator

  • Maxwell Skor, Morgan Stanley.

    麥克斯韋‧斯科爾,摩根士丹利。

  • Maxwell Skor - Analyst

    Maxwell Skor - Analyst

  • I was just wondering when we can expect preclinical data supporting YORVIPATH's potential for weekly dosing? And also, could you share your outlook on YORVIPATH's trajectory in Europe? How should we think about a potential ramp next year?

    我想知道我們什麼時候才能看到支持YORVIPATH每週給藥方案潛力的臨床前數據?另外,您能否分享一下您對 YORVIPATH 在歐洲的發展軌跡的看法?我們該如何看待明年可能出現的產能爬坡問題?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Yes. Typically, what we're doing is that we will like in the beginning of the year, there's a conference. And likely there, we typically will come up with a data and status on our new product opportunities, and we expect to repeat the same element year-by-year. So a good time to expect to see data will be at the beginning of this year.

    是的。通常情況下,我們會在年初舉辦一次會議。而且,我們通常會在那裡公佈有關新產品機會的數據和現狀,我們預計每年都會重複相同的內容。因此,預計今年年初將是看到相關數據的最佳時機。

  • Scott Smith - Chief Financial Officer, Executive Vice President, Member of the Executive Board

    Scott Smith - Chief Financial Officer, Executive Vice President, Member of the Executive Board

  • If he's talking the guidance on OUS?

    他指的是OUS的指導意見嗎?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Ex-US, what we said for this year here is EUR4 million to EUR5 million increase quarter-by-quarter. What we said, this will further be accelerated when we come into '26 because we will have an addition of more and more countries. When we come into January, we will give you the perspective of what countries we expect to add in to the being fully commercial in '26 and '27.

    除美國以外,我們預計今年每季將成長 400 萬至 500 萬歐元。正如我們所說,到了 2026 年,這種情況將會進一步加速,因為會有越來越多的國家加入。到了1月份,我們將向大家介紹我們預計在2026年和2027年全面實現商業化的國家。

  • Operator

    Operator

  • Clara Dong, Jefferies.

    克拉拉‧董,傑富瑞。

  • Yuxi Dong - Analyst

    Yuxi Dong - Analyst

  • And just to follow up on the previous question, and I apologize if you've mentioned already, but it would be great if you can confirm the US and ex-US revenue split for YORVIPATH. And then in terms of the ex-U.S. launch momentum, is there any specific time line for any upcoming reimbursement decision in any market and any pricing dynamic we should keep in mind as you expand internationally?

    我再補充一下先前的問題,如果您已經提到過,我深表歉意,但如果您能確認一下 YORVIPATH 在美國和美國以外地區的收入佔比,那就太好了。那麼,就美國以外的市場推出勢頭而言,在任何市場即將出台的報銷決定是否有具體的時間表?在你們進行國際擴張時,我們應該注意哪些定價動態?

  • Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

    Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director

  • Okay. So we gave you an algorithm for basic in the beginning of the year. We said that when you look in Q4 '24, there was about EUR14 million in net revenue. All this net revenue was basic ex-US. And we expected to add EUR4 million to EUR5 million net revenue in '25 every quarter. So you can nearly add 14 to 5, plus 5, plus 5, plus 5 and then you have the Q4. What we saw in here in '25, we got Spain full commercial.

    好的。所以年初的時候我們就給你們提供了一個基礎演算法。我們曾說過,2024 年第四季淨收入約 1,400 萬歐元。所有這些淨收入都是美國以外的基本收入。我們預計 2025 年每季淨收入將增加 400 萬至 500 萬歐元。所以你可以把 14 加 5,再加 5,再加 5,再加 5,然後你就拿到 Q4了。我們在 2025 年看到的景象,讓西班牙全面商業化。

  • We are in a situation where we not compromise the value because we have a doable product that basically will be here for 20 years. So for us, it's more important to really have the value being created in the right manner. And what we will give you here in the beginning of the year, the perspective of what and how many new countries we expect to add on in '26.

    我們現在的情況是,我們不能在價值上妥協,因為我們有一個可行的產品,它基本上可以存在20年。所以對我們來說,更重要的是以正確的方式創造價值。今年年初,我們將向大家介紹我們預計在 2026 年新增哪些國家以及新增多少個國家。

  • Operator

    Operator

  • Thank you, and that's all the time we have. Thank you for joining. You may now disconnect. Good day.

    謝謝,我們時間就到此為止了。感謝您的參與。您現在可以斷開連線了。再會。

  • Scott Smith - Chief Financial Officer, Executive Vice President, Member of the Executive Board

    Scott Smith - Chief Financial Officer, Executive Vice President, Member of the Executive Board

  • Thanks a lot.

    多謝。