Krystal Biotech Inc (KRYS) 2025 Q3 法說會逐字稿

Thank you for standing by, and welcome to the Krystal Biotech third-quarter 2025 earnings call. (Operator Instructions) As a reminder, today's conference is being recorded. I would now like to hand the conference over to your host, Stephane Paquette, Vice President of Corporate Development. Please begin.

感謝您的耐心等待，歡迎參加 Krystal Biotech 2025 年第三季財報電話會議。（操作說明）提醒各位，今天的會議正在錄音。現在我謹將會議交給主持人，企業發展副總裁史蒂芬‧帕奎特。請開始。

Good morning and thank you all for joining today's call. Earlier today, we released our financial results for the third quarter of 2025. The press release is available on our website at www.crystalbio.com. We also filed our earnings 8-K and 10-Q with the SEC earlier today.

早安，感謝各位參加今天的電話會議。今天早些時候，我們發布了 2025 年第三季的財務表現。新聞稿可在我們的網站www.crystalbio.com上查閱。我們今天稍早也向美國證券交易委員會提交了8-K和10-Q季度財報。

Joining me today will be Krish Krishnan, Chairman and Chief Executive Officer; Suma Krishnan, President of Research and Development; Laurent Goux, Senior Vice President and General Manager for Europe, and Kate Romano, Chief Accounting Officer.

今天與我一同出席的有：董事長兼執行長 Krish Krishnan；研發總裁 Suma Krishnan；歐洲高級副總裁兼總經理 Laurent Goux；以及首席會計官 Kate Romano。

This conference call will and our responses to questions may contain forward-looking statements. You are cautioned not to rely on these forward-looking statements, which are based on current expectations using the information available as of the date of this call and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected. A description of these risks, uncertainties, and other factors can be found in our SEC filings.

本次電話會議以及我們對問題的回答可能包含前瞻性陳述。請注意，不要依賴這些前瞻性陳述，這些陳述是基於截至本次電話會議之日可獲得的資訊做出的當前預期，並且受到某些風險和不確定性的影響，這些風險和不確定性可能導致公司的實際業績與預期業績存在重大差異。有關這些風險、不確定性及其他因素的描述，請參閱我們提交給美國證券交易委員會的文件。

With that, I will turn the call over to Krish.

接下來，我將把電話交給克里什。

Thank you, Stephane. Good morning, and welcome to the call. It gives me immense pride to realize that we're now in a position to help so many DEB patients within and outside the US. I would like to thank the entire team at Krystal for their contributions.

謝謝你，史蒂芬。早上好，歡迎參加電話會議。讓我感到無比自豪的是，我們現在能夠幫助美國境內外的眾多 DEB 患者。我要感謝Krystal團隊的全體成員所做的貢獻。

In Q3, VYJUVEK launch continued to build momentum and the updated US label clearly strengthens long-term outlook in the US. We're now launched in Germany, France, and Japan. We successfully negotiated pricing in Japan and we believe the outcome bodes well for our payer conversations in Europe.

第三季度，VYJUVEK 的上市動能持續增強，更新後的美國標籤也明顯增強了在美國的長期前景。我們現在已經在德國、法國和日本推出了服務。我們在日本成功進行了定價談判，我們相信這一結果預示著我們在歐洲與支付方的談判將會取得良好進展。

We are looking forward to our readout in CF this quarter and we're accelerating enrollment across our pipeline, including KB801 for NK. We are initiating a new clinical program for Hailey-Hailey disease. It is a rare genetic disease of the skin that is a strong fit with our HSV1 gene delivery platform and our commercial footprint. Suma will share more about this program later on the call. Financially, we're strong and well positioned to execute on our strategic growth plans and deliver value to shareholders.

我們期待本季在 CF 領域獲得結果，並且我們正在加快整個產品線的招募工作，包括用於 NK 的 KB801。我們正在啟動一項針對海利-海利病的全新臨床計畫。這是一種罕見的皮膚遺傳疾病，與我們的 HSV1 基因遞送平台和商業佈局非常契合。蘇瑪稍後會在電話會議上詳細介紹這個項目。從財務角度來看，我們實力雄厚，完全有能力執行我們的策略成長計劃，並為股東創造價值。

Moving now to our 3Q results. We are pleased to report another quarter of revenue growth with net base revenue coming in at $97.8 million. The patient pausing impacts due to summer holidays that we observed earlier last quarter were mitigated by patient adds and early traction in Europe.

接下來來看我們第三季的業績。我們很高興地宣布，本季營收再次實現成長，淨基礎營收達到 9,780 萬美元。我們在上個季度早些時候觀察到的因暑假導致的患者暫停就診的影響，已被歐洲新增患者和早期就診人數所緩解。

Net VYJUVEK revenues reported here does include a contribution from Europe, following our launch in Germany in late August. This brings total net VYJUVEK revenues since launch to over $623 million. Gross margins were 96% for the quarter. Gross to net dynamics were stable as with prior quarters.

此處報告的 VYJUVEK 淨收入包括來自歐洲的貢獻，因為我們在 8 月下旬在德國推出了產品。這使得 VYJUVEK 自推出以來的總淨收入超過 6.23 億美元。本季毛利率為96%。與前幾季一樣，毛利與淨利的變動保持穩定。

I'm happy to report continued acceleration in new reimbursement approvals in the US. Our team added over 40 new approvals since our last earnings call update, bringing the total number of reimbursement approvals in the US to over 615. This is now our second sequential quarter of reimbursement approval acceleration and a reflection of our field team's efforts as was the ongoing sales force expansion.

我很高興地報告，美國新的健保報銷審批速度持續加快。自上次財報電話會議更新以來，我們的團隊新增了 40 多項審批，使美國報銷審批總數超過 615 項。這已經是我們連續第二季加快報銷審批速度，這反映了我們現場團隊的努力，以及銷售團隊的持續擴張。

Our expanded field force is now fully hired and being deployed as training is completed. Full impact is expected in early 2026. We're also happy to report continued expansion of our prescriber work, reflecting increased penetration into the community setting with a total number of prescribers in the US now exceeding 450.

我們擴大的現場工作人員現已全部招滿，隨著培訓的完成，他們將陸續部署到位。預計將於 2026 年初產生全面影響。我們也很高興地報告，我們的處方醫生工作持續擴大，反映出我們在社區環境中的滲透率不斷提高，目前美國處方醫生的總數已超過 450 人。

I would like to highlight a recent milestone achieved in the US, which was the FDA approval of our updated VYJUVEK label. This label update expanded the VYJUVEK eligible patient population to include DEB patients from birth and also provided patients with full flexibility in how they choose to dose VYJUVEK. This change reinforces VYJUVEK's leadership position as the most flexible and convenient corrective therapy for DEB and should serve as a tailwind for adoption and compliance in the future.

我想重點介紹一下我們最近在美國取得的一個里程碑式的成就，那就是我們更新的 VYJUVEK 標籤獲得了 FDA 的批准。此次標籤更新擴大了 VYJUVEK 適用患者群體，包括從出生起就患有 DEB 的患者，並且還為患者提供了選擇 VYJUVEK 劑量的完全靈活性。這項變更鞏固了 VYJUVEK 作為 DEB 最靈活、最便捷的矯正療法的領先地位，並應在未來促進其普及和推廣。

Compliance to weekly therapy continued the trend we reported in previous quarters coming in, in the low-80s as more patients achieve durable wound closure and more mild and moderate patients come on to therapy. While the device label change should have a positive impact to compliance in the future, we, as always, continue to expect some quarter-to-quarter waviness in the US revenues as we build on our long-term growth trajectory.

每週治療的依從性延續了我們前幾季報告的趨勢，目前在 80% 左右，因為越來越多的患者實現了持久的傷口癒合，並且越來越多的輕度和中度患者開始接受治療。雖然設備標籤的變更應該會對未來的合規性產生積極影響，但我們一如既往地預計，隨著我們長期成長軌蹟的推進，美國收入仍會出現一些季度間的波動。

With that, I'll now hand it off to Laurent to share his excitement in Europe. Laurent?

接下來，我將把鏡頭交給洛朗，讓他分享他在歐洲的激動心情。洛朗？

Thank you, Krish. It is my pleasure to share an update on our progress in Europe. Our first European launch in Germany is off to a good start. Since launching in late August, we have seen wide expressed interest and demand across the country. Based on available aggregate level data, we estimate the number of patients prescribed VYJUVEK in Germany to be approximately 20.

謝謝你，克里什。我很高興與大家分享我們在歐洲的最新進展。我們在德國的首次歐洲發表會進展順利。自八月下旬推出以來，我們已經看到全國各地都表現出了廣泛的興趣和需求。根據現有總結數據，我們估計德國約有 20 名患者被處方了 VYJUVEK。

Just as importantly, we are seeing broad prescribing patterns across the country with prescription from over 10 centers to date. This breadth of prescribing is particularly helpful given the requirement for patients to stop therapy in a healthcare setting.

同樣重要的是，我們看到全國各地的處方模式都很廣泛，迄今為止已有超過 10 個中心開出了處方。考慮到患者需要在醫療機構停止治療，這種廣泛的處方規定尤其有幫助。

By growing the number of centers prescribing VYJUVEK, we can help patients to stop therapy closer to home and avoid potential single-center patient visit bottlenecks. Based on current trends, we expect continued steady growth in patients' inclusion in the months ahead.

透過增加開立 VYJUVEK 處方的中心數量，我們可以幫助患者在離家更近的地方停止治療，並避免可能出現的單中心患者就診瓶頸。根據目前的趨勢，我們預計未來幾個月患者納入人數將持續穩定成長。

We are also making rapid progress outside of Germany. In September, the Haute Autorité de Santé, also known as HAS, the French HTA body, approved early VYJUVEK access under the post-marketing authorization Accès Précoce 2. And last month, we formally launched by VYJUVEK in France.

我們在德國以外的地區也取得了快速進展。9 月，法國衛生技術管理局 (Haute Autorité de Santé，簡稱 HAS) 批准了 VYJUVEK 在上市後授權 Accès Précoce 2 下的提前使用。上個月，我們透過 VYJUVEK 在法國正式發布了產品。

Importantly, the relevant authorities in France are also allowing VYJUVEK to be dispensed outside the hospital setting. This is the first time a gene therapy has been approved in such a setting in France, a tremendous milestone to our local team and patients across the country.

值得注意的是，法國相關當局也允許在醫院外分發 VYJUVEK。這是法國首次在這種環境下批准基因療法，對於我們當地的團隊和全國各地的患者來說，這是一個巨大的里程碑。

Last month, HAS also approved VYJUVEK under the Amélioration Service Médical Rendu or ASMR classification system, a key initial steps for pricing and reimbursement discussions in France. VYJUVEK received an ASMR III designation. This designation, which was only granted to 11% of the new drugs reviewed in 2024, acknowledged the added clinical benefit of VYJUVEK and may open up the possibility for EU priority list pricing in France.

上個月，HAS 還根據 Amélioration Service Médical Rendu 或 ASMR 分類系統批准了 VYJUVEK，這是法國定價和報銷討論的關鍵初步步驟。VYJUVEK 獲得了 ASMR III 認證。該頭銜僅授予 2024 年審查的新藥中的 11%，它認可了 VYJUVEK 的額外臨床益處，並可能為法國獲得歐盟優先定價清單帶來可能性。

Finally, I'm also proud to report that VYJUVEK was granted the Prix Galien in Italy under the Advanced Therapy Medicinal Product category, a prestigious award recognizing excellence in scientific innovation to improve the state of human health. This award is an important acknowledgment of the innovative and transformational nature of VYJUVEK and a helpful touch point as we start to engage with the relevant stakeholders in Italy.

最後，我還要自豪地宣布，VYJUVEK 榮獲義大利蓋倫獎（Prix Galien）先進療法藥品類別獎項，這是一項表彰在科學創新方面取得卓越成就以改善人類健康的著名獎項。該獎項是對 VYJUVEK 創新性和變革性的重要認可，也是我們開始與義大利相關利害關係人接觸的一個有益的切入點。

With these recent achievements, we are excited about the long-term growth trajectory in Europe and maximizing VYJUVEK access to the thousands of DEB patients in the region. I now hand the call back over to Krish.

憑藉這些近期的成就，我們對歐洲的長期成長軌跡感到興奮，並致力於最大限度地讓該地區的數千名 DEB 患者能夠獲得 VYJUVEK 治療。現在我把電話轉回給克里什。

Thanks, Laurent. As I mentioned before, we have now also launched VYJUVEK in Japan. This summer, we were approved by the MHLW for the treatment of patients. And late last month, we successfully completed pricing negotiations with the Japanese authorities and launched VYJUVEK.

謝謝你，洛朗。正如我之前提到的，我們現在也在日本推出了 VYJUVEK。今年夏天，我們獲得了厚生勞動省的批准，可以開始為患者提供治療。上個月底，我們成功完成了與日本當局的價格談判，並推出了 VYJUVEK。

We're very pleased with our pricing in Japan, and that is a testament to the clinical benefits achieved by their patients treated with VYJUVEK. Our core Japanese team has been in place for over a year and is now fully staffed to support the VYJUVEK launch.

我們對在日本的定價非常滿意，這證明了使用 VYJUVEK 治療的患者所獲得的臨床益處。我們的核心日本團隊已經組建一年多，現在人員配備齊全，可以支援 VYJUVEK 的發布。

Our Japanese medical team has also been active for over a year, mapping key centers and patients, which will be the early focus of our launch. Although we expect contribution from Japan in 2025 to be modest, it will be another important revenue growth driver in 2026.

我們的日本醫療團隊也已積極開展工作一年多，繪製了重點醫療中心和患者的分佈圖，這將是我們初期工作的重點。儘管我們預計日本在 2025 年的貢獻將比較有限，但它將在 2026 年成為另一個重要的收入成長驅動力。

Finally, I wanted to highlight one more contributor to the long-term growth of VYJUVEK. In addition to our direct VYJUVEK launches in the US, major European markets, and Japan, we started contracting with regional specialty distributors to support the commercialization of VYJUVEK in rest of the world markets. We have executed agreements in place with multiple leading distributors covering key markets in Central and Eastern Europe, Turkey, and the Middle East and expect to add more in the year ahead.

最後，我想重點介紹一位對 VYJUVEK 的長期發展做出貢獻的人。除了在美國、歐洲主要市場和日本直接推出 VYJUVEK 之外，我們還開始與區域專業分銷商簽訂合同，以支持 VYJUVEK 在世界其他市場的商業化。我們與多家領先的經銷商簽訂了協議，涵蓋中歐和東歐、土耳其和中東的主要市場，並預計在未來一年內增加更多經銷商。

Healthcare infrastructure and access vary significantly across rest of the world markets, but even after accounting for this variability, we estimate that a global distributor partner network could help bring VYJUVEK to thousands more DEB patients around the world and supplement our exciting growth strategy in the United States, Europe, and Japan. With that, I'll now hand it off to Suma to touch on recent pipeline progress. Suma?

世界其他地區的醫療保健基礎設施和獲取途徑差異很大，但即使考慮到這種差異，我們估計，全球分銷合作夥伴網絡可以幫助 VYJUVEK 惠及世界各地成千上萬的 DEB 患者，並補充我們在美國、歐洲和日本令人振奮的增長戰略。接下來，我將把發言權交給蘇瑪，讓她談談最近的管道建設進度。蘇瑪？

Thank you, Krish. I would like to start today by acknowledging the hard work of our development team here at Krystal. In recent months, we have dramatically transformed the scope and ambition of our clinical stage pipeline, expanding our clinical programs in respiratory and oncology, and starting up new studies in ophthalmology and dermatology. These are all important achievements, none of which would be possible without the size contribution of each Krystal team member.

謝謝你，克里什。首先，我想對我們Krystal開發團隊的辛勤工作表示感謝。近幾個月來，我們大幅改變了臨床階段研發管線的範圍和目標，擴大了呼吸系統和腫瘤領域的臨床項目，並啟動了眼科和皮膚科的新研究。這些都是重要的成就，如果沒有 Krystal 團隊每位成員的巨大貢獻，這一切都不可能實現。

Our team also achieved another important milestone in recent weeks: a platform therapy designation from the FDA. This designation granted for our HSV1 gene delivery platform and currently applicable to our KB801 program could significantly accelerate the path to approval, providing us the opportunity for more frequent interactions with the FDA and as well as the chance to leverage manufacturing and nonclinical safety data from VYJUVEK in our filings.

最近幾週，我們的團隊也取得了另一個重要的里程碑：獲得了美國食品藥物管理局 (FDA) 的平台療法認定。這項授予我們 HSV1 基因遞送平台的認定目前適用於我們的 KB801 項目，可能會顯著加快審批進程，使我們有機會與 FDA 進行更頻繁的互動，並有機會在我們的申請中利用 VYJUVEK 的生產和非臨床安全性數據。

The FDA may also consider previous inspectional findings related to drug manufacture. The platform technology designation is applied for -- on a program-by-program basis and is currently only granted to KB801, although we intend to apply for this designation for additional programs to ultimately secure the designation and associated efficiencies of our entire pipeline.

FDA 也可能考慮先前與藥品生產相關的檢查結果。平台技術認證是逐個專案申請的，目前僅授予 KB801，儘管我們打算為其他專案申請此認證，以最終確保我們整個產品線獲得認證和相關的效率。

I'm also excited to report that we remain on track to deliver multiple exciting readouts in the months ahead. We expect our next readout to come from our cystic fibrosis program, KB407. With the backing of the [CFFTDN], we have expanded our clinical trial network and are now very close to study completion.

我也很高興地報告，我們仍按計劃在未來幾個月內發布多項令人振奮的消息。我們預計下一次的讀數將來自我們的囊性纖維化項目 KB407。在 [CFFTDN] 的支持下，我們擴大了臨床試驗網絡，目前已接近完成研究。

We look forward to announcing interim data before year-end, including molecular data from null CF patients to assess the ability of the HSV-1 to deliver full-length, wild-type CFTR to the lung. On success, we would expect to immediately move to repeat dosing study which would enable assessment of functionality, including longitudinal FEV1. With our now expanded trial network and without the requirement for bronchoscopies, we expect a repeat dosing study would enroll quickly, enabling a potential FEV1 data readout next year.

我們期待在年底前公佈中期數據，包括來自 CF 基因缺失患者的分子數據，以評估 HSV-1 將全長野生型 CFTR 輸送到肺部的能力。如果成功，我們希望立即進行重複給藥研究，以便評估其功能，包括縱向 FEV1。憑藉我們現已擴大的試驗網絡，並且無需進行支氣管鏡檢查，我們預計重複給藥研究將很快招募受試者，從而有可能在明年獲得 FEV1 數據讀數。

Our KB408 program for AATD lung disease is also moving ahead well. Having already confirmed successful delivery of functional AAT in our single-dose study, this program is in repeat dosing, and we expect to be able to provide an interim data update in the first half of next year. Together with KB407, this will serve as a robust data set demonstrating our platform capabilities in the lung.

我們針對 AATD 肺部疾病的 KB408 計畫也進展順利。在我們的單劑量研究中已經證實功能性 AAT 的遞送成功，該計畫正在進行重複給藥，我們預計將在明年上半年提供中期數據更新。結合 KB407，這將構成一個強大的數據集，展示我們平台在肺部的應用能力。

In ophthalmology, strong enrollment is providing us with greater clarity on the timing of our first readout. Based on current rates, we expect to complete enrollment of our Phase 3 trial, evaluating KB803 for corneal abrasions in DEB patients by end of the year. Enrollment in our randomized placebo-controlled study or KB801 in NK is also progressing well as we continue to onboard new sites globally, setting us for a potential data reach in 2026.

在眼科領域，強勁的入組率讓我們對首次結果公佈的時間有了更清晰的了解。根據目前的進展速度，我們預計在年底前完成 3 期試驗的入組，該試驗旨在評估 KB803 對 DEB 患者角膜擦傷的療效。我們正在進行針對 NK 患者的隨機安慰劑對照研究或 KB801 的招募工作，目前進展順利，我們正在全球範圍內不斷引入新的研究中心，預計在 2026 年獲得潛在數據。

I would also like to share a quick update on our work in oncology, which is increasingly focused on the development of inhaled KB707 for the treatment of non-small cell lung cancer or NSCLC. As we shared at ASCO over the summer, NSCLC is an indication where we have seen early evidence of monotherapy efficacy even in heavily pretreated and checkpoint inhibitor-failed patients.

我也想快速分享我們在腫瘤學領域的工作進展，我們越來越專注於開發吸入式 KB707，用於治療非小細胞肺癌（NSCLC）。正如我們在今年夏天的 ASCO 會議上分享的那樣，非小細胞肺癌 (NSCLC) 是我們已經看到單藥治療療效早期證據的適應症，即使是對於接受過大量預處理和檢查點抑製劑治療失敗的患者也是如此。

Building on that readout, we were recently granted an end of Phase 2 meeting with the FDA to discuss potential development pathway for inhaled KB707. Based on FDA's feedback, we now expect that a single Phase 3 study evaluating inhaled KB707 in combination with chemotherapy versus chemotherapy alone in patients with advanced NSCLC could be sufficient to support a potential registration in combination for second-line NSCLC.

基於該結果，我們最近獲得了與 FDA 召開的 2 期臨床試驗結束會議，討論吸入式 KB707 的潛在開發途徑。根據 FDA 的回饋，我們現在預計，一項評估吸入 KB707 與化療聯合治療晚期 NSCLC 患者與單獨化療的 3 期研究，可能足以支持其作為二線 NSCLC 聯合治療的潛在註冊。

In support of this potential registration pathway, we have opened a new cohort in our ongoing Phase 1/2 KYANITE-1 study to evaluate a fixed dose of inhaled KB707 in combination with chemotherapy. Enrollment in KYANITE-1 is ongoing. Our current expectation is to report interim data from KYANITE-1 in the second half of 2026 at which point, we would also be able to provide an update on registrational study plans and potential for Phase 3 initiation.

為了支持這一潛在的註冊途徑，我們在正在進行的 1/2 期 KYANITE-1 研究中開設了一個新的隊列，以評估吸入固定劑量的 KB707 與化療聯合使用的效果。KYANITE-1課程正在招生中。我們目前的預期是在 2026 年下半年公佈 KYANITE-1 的中期數據，屆時，我們還將能夠提供有關註冊研究計劃和啟動 3 期試驗的可能性的最新資訊。

Finally, I'm also happy to introduce today a new addition to our clinical pipeline, KB111 for the treatment of Hailey-Hailey disease. Hailey-Hailey disease is a genetic blistering disease of the skin linked to the mutation in the ATP2C1 gene and low expression of its encoded caption transporting ATPS.

最後，我很高興地向大家介紹我們臨床研發管線的新成員—用於治療海利-海利病的 KB111。Hailey-Hailey 病是一種遺傳性皮膚水皰病，與 ATP2C1 基因突變及其編碼的轉運 ATPS 的低表達有關。

HHD is a rare disease with a prevalence that's not well understood. The most common estimate of prevalence is 1 case for 50,000 patients, although underreporting is possible. HHD is characterized by painful rash and blistering in skin folds with a relapsing remitting course that is exacerbated by heat and sweat.

HHD是一種罕見疾病，其盛行率尚不明確。最常見的盛行率估計是每 50,000 名患者中有 1 例，但可能有漏報。HHD 的特徵是皮膚皺褶處出現疼痛性皮疹和水皰，呈現復發緩解性病程，受熱和出汗會加重病情。

Patients often report debilitating symptoms of pain, itch, burning, body odor, as well as infections, resulting in severe negative impact on quality of life, technological distress, and intimacy issues. There are no specific therapies available for treatment of this disease.

患者經常會報告出現疼痛、搔癢、灼熱、體味以及感染等令人痛苦的症狀，導致生活品質受到嚴重負面影響，出現技術困擾和親密關係問題。目前尚無針對此疾病的特效療法。

Building on our experience and clinically validated HSV platform for skin delivery, we designed KB111 to deliver ATP2C1 directly to skin cells, increase ATPase levels, and hopefully change the course of this terrible disease. As with VYJUVEK, KB111 is formulated for a topical administration directly to the lesions of HHD patients.

基於我們豐富的經驗和經臨床驗證的 HSV 皮膚遞送平台，我們設計了 KB111，將 ATP2C1 直接遞送到皮膚細胞，提高 ATPase 水平，並有望改變這種可怕疾病的進程。與 VYJUVEK 一樣，KB111 的配方是直接局部塗抹於 HHD 患者的病灶部位。

We've already confirmed in preclinical studies that KB111 can efficiently transduce skin cells, resulting in functional ATPase expression, and last month, cleared our [I&E]. We expect to start an intra-patient randomized, double-blind, placebo-controlled multicenter study evaluating KB111 in HHD patients in the first half of next year.

我們在臨床前研究中證實，KB111 可以有效轉導皮膚細胞，從而產生功能性 ATPase 表達，並且上個月，我們獲得了批准。[IE]。我們預計明年上半年啟動一項患者內隨機、雙盲、安慰劑對照的多中心研究，評估 KB111 在 HHD 患者的療效。

With strong execution across our pipeline and now the added benefits of the platform designation for KB801, we are well positioned to make rapid progress with multiple readouts in months ahead. With that, I'll hand the call over to Kate.

憑藉我們整個研發管線的強勁執行力，以及 KB801 平台指定的額外優勢，我們已做好充分準備，在未來幾個月內透過多次讀數取得快速進展。這樣，我就把電話交給凱特了。

Thank you, Suma, and good morning, everyone. I'd like to provide some highlights from our third-quarter financial results reported in our press release and 10-Q filing earlier this morning. VYJUVEK net product revenue for the third quarter was $97.8 million. This marks sustained growth as compared to the prior quarter, including the early sales from our German launch.

謝謝你，蘇瑪，大家早安。我想重點介紹一下我們今天早上在新聞稿和 10-Q 文件中公佈的第三季財務業績。VYJUVEK 第三季淨產品營收為 9,780 萬美元。與上一季相比，這標誌著持續成長，其中包括我們在德國上市後的早期銷售。

Gross to net revenues remained consistent with prior quarters. Cost of goods sold was $4.3 million and gross margin was 96% for the quarter as compared to 93% last quarter. Note that the increase in gross margin this quarter was the result of US product manufacturing process optimization and the benefit of lower cost batches after FDA approval of this optimized process.

毛收入與淨收入之比與前幾季保持一致。本季銷售成本為 430 萬美元，毛利率為 96%，上一季為 93%。請注意，本季毛利率的成長是由於美國產品製造流程的最佳化以及FDA批准此優化製程後降低批次成本所帶來的好處。

While we expect these manufacturing efficiencies to continue benefiting our US operations, the optimized process has not yet been approved for products sold outside the United States. As ex-US sales grow over the coming quarters, we anticipate gross margins will normalize towards historical levels until the optimized process is approved for products sold outside the United States.

雖然我們預計這些生產效率的提高將繼續惠及我們在美國的運營，但優化後的流程尚未獲得在美國以外地區銷售的產品的批准。隨著未來幾季美國以外地區的銷售成長，我們預計毛利率將恢復到歷史水平，直到針對美國以外地區銷售的產品的優化流程獲得批准。

Research and development expenses were $14.6 million and general and administrative expenses were $37.6 million. Operating expenses for the quarter included noncash stock-based compensation of $13.2 million.

研發費用為 1,460 萬美元，一般及行政費用為 3,760 萬美元。本季營運費用包括 1,320 萬美元的非現金股票補償。

You'll note on slide 13 that we are revising our full-year non-GAAP R&D and SG&A guidance to $145 million to $155 million, compared to our prior guidance of $150 million to $175 million. This represents both a reduction and narrowing of the range to better reflect our performance so far this year as well as our continued confidence in our ability to execute with discipline for the remainder of the year.

您會在第 13 頁投影片中註意到，我們將全年非 GAAP 研發和 SG&A 預期從先前的 1.5 億美元至 1.75 億美元調整為 1.45 億美元至 1.55 億美元。這既代表著預期範圍的縮小和調整，以更好地反映我們今年迄今為止的業績，也代表著我們對今年剩餘時間能夠有紀律地執行計劃的持續信心。

During the quarter, we released a majority of the valuation allowance that was previously recorded against our deferred tax assets, reflecting our confidence in Krystal's future profitability. This release resulted in a onetime noncash tax benefit that increased our reported EPS.

本季度，我們釋放了先前提列的大部分遞延所得稅資產估值準備金，這反映了我們對 Krystal 未來獲利能力的信心。此次發行帶來了一次性非現金稅收優惠，提高了我們報告的每股收益。

We also benefited from the reversal of the Section 174 R&D capitalization requirement under the One Big Beautiful Bill legislation. This reversal was also nonrecurring. Net income for the quarter was $79.4 million, which represented $2.74 per basic and $2.66 per diluted share, reflective of these onetime benefits.

我們也受惠於《一項偉大的法案》立法中第 174 條研發資本化要求的取消。這種逆轉也並非再發生。本季淨收入為 7,940 萬美元，相當於每股基本收益 2.74 美元，每股攤薄收益 2.66 美元，反映了這些一次性收益。

And finally, our balance sheet continues to be a key point of strength for Krystal. We ended the third quarter with over $864 million in combined cash and investments and we remain well positioned to support our commercial launches globally as well as our significant pipeline programs in the upcoming quarters.

最後，我們的資產負債表仍然是 Krystal 的關鍵優勢。第三季末，我們擁有超過 8.64 億美元的現金和投資，我們仍然處於有利地位，能夠支持我們在未來幾季在全球範圍內的商業發布以及重要的研發管線項目。

And now, I will turn the call back over to Krish.

現在，我將把電話轉回給克里什。

Thanks, Kate. As we close today's call, I'd like to emphasize our excitement for the path ahead at Krystal in 2026. With launches in Germany, France, and Japan, VYJUVEK has now truly gone global, providing us the opportunity to dramatically expand the number of patients benefiting from VYJUVEK therapy in the months ahead. The hard part of a global VYJUVEK launch is now behind us, and Krystal's focus in 2026 is on our clinical pipeline.

謝謝你，凱特。在今天的電話會議即將結束之際，我想強調我們對 Krystal 在 2026 年的發展前景感到無比興奮。隨著 VYJUVEK 在德國、法國和日本的上市，它現在真正走向了全球，這為我們提供了在未來幾個月內大幅增加受益於 VYJUVEK 療法的患者數量的機會。VYJUVEK 全球上市的艱難階段已經過去，Krystal 在 2026 年的重點是我們的臨床研發管線。

We have our first readout in CF before year-end. We're working towards readouts in 801 for NK and KB803 for eye lesions in DEB patients by midyear and we shall update once enrollment is complete in these programs. These programs, along with KB111 for Hailey-Hailey, fit neatly within our core global commercial capabilities.

我們將在年底前獲得CF的首份讀數。我們正在努力爭取在年中之前獲得 NK 801 和 DEB 患者眼部病變 KB803 的讀數，一旦這些項目的招募完成，我們將進行更新。這些項目，連同 Hailey-Hailey 的 KB111 項目，都完美契合我們的核心全球商業能力。

At the same time, we recognize a significant optionality that HSV-1 provides as a redoseable, non-integrating, large-capacity gene delivery platform and the potential upside opportunities that exist in large market indications. We will continue to invest in these programs with the same operational discipline as we have in the past to ensure that we maximize the value that we believe exists in our pipeline and platform before entering into partnerships for these programs.

同時，我們認識到 HSV-1 作為一種可重複給藥、非整合、大容量基因遞送平台具有重要的選擇權，並且在大市場適應症方面存在潛在的成長機會。我們將繼續以與以往相同的營運紀律投資於這些項目，以確保在與合作夥伴開展這些項目之前，最大限度地發揮我們認為存在於我們的研發管線和平台中的價值。

Thanks for listening, and I'd like to now open the call for Q&A.

謝謝大家的聆聽，現在我想進入問答環節。

(Operator Instructions) Alec Stranahan, Bank of America.

（操作說明）美國銀行 Alec Stranahan。

Hey, guys. This is [Matthew] on for Alec. Congrats on the quarter. Appreciate you taking our questions. Maybe just two from us.

嘿，夥計們。這是馬修替亞歷克發言。恭喜你本季取得佳績。感謝您回答我們的問題。或許我們只有兩個。

On the ex-US launch, I guess, whether your focus is on expanding the breadth of prescribers or depth of prescribers that have already made some prescriptions? And then maybe on the optimized process that led to better gross margins, just curious what was optimized in this process and whether you can speak to timelines for this optimized process to be expanded to ex-US markets?

關於美國以外的推廣，我想問的是，你們的重點是擴大處方醫生的範圍，還是加深已經開過一些處方的處方醫生的參與度？那麼，關於能夠帶來更高毛利率的優化流程，我很好奇這個流程優化了哪些方面，以及您能否談談這個優化流程何時會推廣到美國以外的市場？

Thank you, Matthew. Hey, in terms of your first question on ex-US launch breadth of prescribers was a step. I mean our focus -- I mean, you know our objective in Europe is primarily to accelerate getting a patient to meet the physician as soon as possible because the first clinical visit has to be in a physician office. Now purely logistically, that's a lot easier if you start focusing on centers of excellence, as you heard from Laurent to begin with, but at the same time, slowly spreading out into the community.

謝謝你，馬修。嘿，關於你提出的第一個問題，即美國以外地區上市後處方醫生的覆蓋範圍，這是一個進步。我的意思是，我們的重點——你知道，我們在歐洲的主要目標是盡快讓病人見到醫生，因為第一次臨床就診必須在醫生辦公室進行。純粹從後勤角度來看，如果你像 Laurent 一開始所說的那樣，專注於卓越中心，同時慢慢地向社區擴展，那就容易多了。

On the question about optimized process, this is essentially moving to a larger bioreactor. It's got approved in the US, and we're working towards an application in Europe. I'll ask someone to comment on the timing for the approval in Europe with respect to the optimized plans.

關於優化製程的問題，這本質上就是轉向更大的生物反應器。它已在美國獲得批准，我們正在努力爭取在歐洲獲得批准。我會請人就歐洲批准優化方案的時間表發表意見。

I mean, we have already started the process. We have filed the scaled up. I mean, it's pretty straightforward because we have a lot of data from the US. So we expect, hopefully, sometime next year to have the optimized and scaled up process approved.

我的意思是，我們已經開始這個過程了。我們已經提交了擴大規模的申請。我的意思是，這很簡單，因為我們有很多來自美國的數據。因此，我們希望，在明年某個時候，優化和擴大規模的流程能夠獲得批准。

Roger Song, Jefferies.

Roger Song，傑富瑞集團。

Great. Congrats for the quarter and thank you for taking our question. Also related to the question on ex-US launch. So I understand the contribution in 3Q probably not too much from Germany. But just curious about your expectation moving to next year, maybe 4Q and the next year, how should we think about ex-US versus the US revenue contribution? And when on the ex-US will you give us some breakdown data on?

偉大的。恭喜您本季取得佳績，感謝您回答我們的問題。也與美國以外的發射問題有關。所以我認為德國在第三季的貢獻可能不會太大。但我很好奇您對明年，或許是第四季以及後年的預期，我們該如何看待美國以外地區與美國本土的營收貢獻？那麼，你們什麼時候會提供一些關於美國以外地區的細分數據呢？

And then also related to this ex-US launches, how should we think about the pricing? I understand you need to negotiate on top of the list of price and then how this will change over time, particularly with the US MSM policy?

另外，對於美國以外的市場，我們該如何考慮定價問題呢？我明白你需要在價格清單的基礎上進行談判，然後還要考慮價格會如何隨時間變化，尤其是在美國主流媒體政策的影響下？

Great. Roger, thanks for those questions. Look, the only requirement, as I mentioned in the prior response, is to start in a healthcare setting. But in spite of that, we think Germany is off to a really good start with like 10-plus centers starting to prescribe.

偉大的。羅傑，謝謝你的提問。正如我在先前的回覆中提到的，唯一的要求就是從醫療保健機構開始。儘管如此，我們認為德國的開局非常好，已經有 10 多個中心開始開處方。

But the only point I'll make with respect to the EU launch, I would expect it to be a steady launch upwards as opposed to expecting any kind of bolus early on in either country, whether it be Germany or France. But the demand and the physicians and the patients are pretty excited, I would say, both in Germany, France, and Italy is starting to go that way too.

但關於歐盟的上市，我唯一想說的是，我預期上市過程會是穩定上升，而不是像德國或法國那樣，在初期出現任何形式的快速成長。但我認為，無論是德國、法國或義大利，需求、醫生和病人都非常興奮，而且這種趨勢也開始朝著這個方向發展。

With respect to pricing, look, we know Germany affords pre-pricing for the first six months. And then internally, we'll make a determination to start accruing for the next 12 months, depending on how pricing is proceeding -- negotiations are proceeding.

至於定價方面，我們知道德國允許前六個月享受預定價。然後，公司內部將根據定價情況（談判正在進行中）決定是否開始提列未來 12 個月的利息。

In France, obviously, we start accruing from day one. So it's very country-specific. But I will say, based on the ASMR rating, based on the pricing regarding Japan, I think it bodes well. It remains to be seen. But I think the efficacy and the debilitating nature of the disease, I think that message, we're doing a really good job of conveying that, and it's being received well by these authorities in different countries.

在法國，很顯然，我們從第一天就開始累積財富。所以這取決於具體國家。但根據 ASMR 的評分和日本的定價來看，我認為這是個好兆頭。此事尚待觀察。但我認為，關於這種疾病的療效和致殘性，我認為我們很好地傳達了這個訊息，而且不同國家的相關部門也對此表示贊同。

Ritu Baral, TD Cowen.

Ritu Baral，TD Cowen。

Hi, guys. Apologies. I was muted. Good morning. Thank you for taking the questions.

嗨，大家好。抱歉。我被靜音了。早安.感謝您回答這些問題。

I have been getting a lot of questions on NK timing and, specifically, Krish, could you take us through what the gating aspects of getting that trial up and going is? How many sites and how difficult it is to open those sites?

我收到了很多關於 NK 試驗時機的問題，特別是 Krish，你能給我們介紹一下啟動和進行該試驗的關鍵方面嗎？網站數量有多少？打開這些網站有多難？

Has enrollment -- formal enrollment actually started? I think there's a lot of focus on the rapidity of getting to data and what that says about the overall NK population prevalence? And then I have a quick follow-up on CF.

正式招生已經開始了嗎？我認為大家非常重視取得數據的速度，以及這反映了NK細胞整體盛行率的什麼情況？然後我還要快速跟進一下囊性纖維化（CF）的情況。

Got you. On NK, I would just say, look, I think we have started to enroll patients in the study. Maybe Suma, you could add some color on how we're proceeding?

抓到你了。關於 NK，我只想說，你看，我認為我們已經開始招募患者參與這項研究了。蘇瑪，你能不能補充一些關於我們下一步工作進展的資訊？

Absolutely. I mean we have we have quite a few sites up and running. We are actively adding additional sites. So really intend not just in the US but globally because there's a lot of NK patients in Europe and the rest of the world, and we want to make this a global filing.

絕對地。我的意思是，我們已經有不少網站上線運行了。我們正在積極增加更多站點。所以，我們的真正目標是不僅在美國，而且在全球範圍內，因為歐洲和世界其他地方有許多 NK 患者，我們希望將其作為全球性申請提交。

So as you know, it takes a little while to get them up and running for the global studies, but we are right in the process. I think we will have most of our sites all completely signed up and ready to go, hopefully, by end of the year.

如您所知，全球研究需要一些時間才能啟動並運行，但我們正在進行中。我希望到今年年底，我們的大部分網站都能完成註冊並準備就緒。

And as you know, we are enrolling patients. This is one of our top priority projects. So we are excited to see the progress on this particular trial.

如您所知，我們正在招募患者。這是我們最重要的項目之一。所以我們很高興看到這項試驗的進展。

And I will add, Ritu, our internal timing target is to announce some minimum data by the middle of next year.

我還要補充一點，Ritu，我們內部的目標是在明年年中公佈一些最低限度的數據。

Got it. And can you say what percentage of sites you have up at -- the percentage of planned sites that you have been running at this point?

知道了。你能告訴我目前已上線的網站佔計畫網站的百分比嗎？

I mean, we have quite a few sites. I mean, within the US, we got most of the academic sites up and running. We have a few more to go, but I think we should have most of the US sites up and running by end of the year.

我的意思是，我們有不少站點。我的意思是，在美國境內，我們已經建成並經營了大部分學術網站。還有一些站點需要搭建，但我認為到今年年底，我們應該能夠讓大部分美國站點投入運作。

Got it. And then for CF, can you tell us how many null patients that you plan to provide data on by the year-end update? And what constitutes success on molecular response? What aspects of molecular response will you be reporting and what's success in a null patient?

知道了。那麼對於 CF 患者，您能否告訴我們，您計劃在年底更新時提供多少次無效患者的資料？那麼，分子反應的成功標準是什麼？您將報告分子反應的哪些方面？對於無反應患者，怎樣才算成功？

Yeah. We're -- Rita, thanks for that question. We are looking, at a minimum, three patients, primarily focused on molecular correction because it's a single-dose study. Suma, anything else?

是的。我們是——麗塔，謝謝你的提問。我們至少會觀察三名患者，主要關注分子矯正，因為這是一項單劑量研究。蘇瑪，還有什麼嗎？

Yeah. I mean, obviously, we are branching these patients, the three null patients, after the drug is administered. And the biopsies, we will take across the different across all the different areas of the lung, and we will look for expression of CFTR by immunofluorescence across.

是的。我的意思是，很顯然，在給藥後，我們會對這些患者（即三名無效患者）進行分組。我們將對肺部的各個不同區域進行活檢，並透過免疫螢光法檢測 CFTR 的表達。

And we will see what kind of expression; we are expecting to see robust expressions. I mean, based on our NHP primate study, I mean, we -- hopefully, we can recreate that. We see expression all the way up to 28 days.

我們將拭目以待，看看會出現什麼樣的表現；我們期待看到強勁的表現。我的意思是，根據我們對非人靈長類動物的研究，我們希望能夠重現這一結果。我們發現最長可達 28 天。

We see full-length molecular CFTR expression across all of our biopsies. We think -- we feel pretty confident. Nobody is able to, today, show full length expression of CFTR. So hopefully, we can break that cycle. That's our goal.

我們在所有活檢樣本中都觀察到了全長 CFTR 分子表現。我們認為──我們感覺相當有信心。目前還沒有人能夠展現 CFTR 的全長表現。所以，希望我們能夠打破這個惡性循環。這就是我們的目標。

Would you report like percentage of normal and what threshold could result in FEV changes at a later time point?

您能否報告一下正常值的百分比，以及在什麼閾值下，FEV 值會在稍後的時間點發生變化？

I mean, we know that you don't need much, right? Even these patients don't produce any CFTR. So even if we can produce anywhere between 5% to 10% of CFTR expression, I think that's pretty robust. So again, our intent is in these multiple biopsies across the lung. We will -- hopefully, we want to show expression in most of these biopsies and that can give us some confidence that, yes, we can express and we have enough molecular correction. So especially in these null patients don't produce any CFTR.

我的意思是，我們知道你不需要太多東西，對吧？即使是這些患者也無法產生任何 CFTR 蛋白。所以即使我們只能產生 5% 到 10% 的 CFTR 表達，我認為這也相當可靠了。所以，我們的目的仍然是對肺部進行多次活檢。我們希望——也希望——在大多數活檢樣本中都能看到表達，這可以給我們一些信心，證明我們能夠表達，並且我們有足夠的分子校正。所以，尤其是這些基因缺失的患者不會產生任何 CFTR。

Gavin Clark-Gartner, Evercore.

Gavin Clark-Gartner，Evercore。

On NK, what makes you confident that you don't need to test any different doses and why the one that you picked is the right dose? And somewhat on this topic, do you think you need two efficacy studies for approval or may one be sufficient?

關於 NK，是什麼讓你確信不需要測試任何不同的劑量，以及為什麼你選擇的劑量是正確的？關於這個主題，您認為獲得批准需要兩項療效研究，還是一項就足夠了？

So the confidence for the dose comes from our animal studies. I mean, we clearly see expression gave a clear pharmacokinetic profile. So we know how long the expression lasts. So that has guided us into the dosing regimen in the clinic.

因此，我們對劑量的信心來自於我們的動物研究。我的意思是，我們清楚地看到，該表達表現出了清晰的藥物動力學特徵。這樣我們就知道這個表達式持續多久了。因此，這指導了我們在臨床上製定給藥方案。

Yes, we are pretty sure that we just need one efficacy trial because this is, again, a rare disease. It meets the regulatory guidance for what the requirement is. So based on our study and the way we have powered the study based on our animal studies and what oxalate studies have achieved, we have powered it to, hopefully, see clinical significant improvement from placebo. So that's the goal of this.

是的，我們非常確定只需要一項療效試驗，因為這又是一種罕見疾病。它符合相關法規要求。因此，根據我們的研究以及我們根據動物研究和草酸鹽研究取得的成果所進行的統計，我們已經統計了統計結果，希望能夠看到與安慰劑相比具有臨床意義的改善。這就是我們的目的。

If the study is successful, then we expect this to be in the registrational trial. And obviously, you have the platform technology. And we have guidance on what we need from a CMC perspective. So we are, I think -- you're aligned. So that's something that's positive for this program.

如果這項研究成功，那麼我們預計它將進入註冊試驗階段。顯然，你們擁有平台技術。我們從CMC的角度獲得了所需的指導。所以我覺得我們是一致的──你們的想法是一致的。所以這對這個項目來說是個積極的方面。

And is there any commentary you can provide on the safety you're seeing in the ocular DEB study or even the NK study on a blinded basis?

您能否就您在眼部 DEB 研究或 NK 盲法研究中觀察到的安全性提供一些評論？

I mean, so far, we have not seen any adverse events of concern.

我的意思是，到目前為止，我們還沒有看到任何令人擔憂的不良事件。

Sami Corwin, William Blair.

薩米·科溫，威廉·布萊爾。

Good morning. Congrats on the progress and thanks for taking my question. I also have one on NK. Could you remind us if you're excluding patients that have had a prior ocular HSV infection? And if you think a prior HSV infection could impact the efficacy or safety of treatment? And then in terms of the initial data set, what exactly will we see in that?

早安.恭喜你取得進展，謝謝你回答我的問題。我在 NK 上也有一個。請問您是否將曾經患有眼部單純皰疹病毒感染的患者排除在外？如果您認為先前 HSV 感染可能會影響治療的療效或安全性？那麼就初始資料集而言，我們究竟會看到什麼呢？

Regarding your first question, no, we do not -- we do not exclude patients that had prior infection. The only requirement is they should not have an active infection. That's the only exclusion criteria. I mean that's so -- (technical difficulty) whenever we announce?

關於你的第一個問題，不，我們不會——我們不會排除曾經感染過的患者。唯一的要求是他們不能患有活動性感染。這是唯一的排除標準。我的意思是，每次我們發佈公告時都會出現這種情況－（技術難題）？

Yeah, data said this is a randomized one-to-one placebo-controlled study eight week. So we look at complete healing. We're using -- I mean, complete healing with an independent reader. So if you see complete healing against placebo, then that's a win, just exactly like Oxervate.

是的，數據顯示這是一項為期八週的隨機一對一安慰劑對照研究。所以我們著眼於完全康復。我們正在使用——我的意思是，透過獨立閱讀進行完全康復。所以，如果與安慰劑相比，你看到完全康復，那就是勝利，就像 Oxervate 一樣。

Got. it. Great. And then just one question on VYJUVEK. Should we expect some guidance or full-year revenue guidance for VYJUVEK early next year?

知道了。偉大的。然後就問一個關於維尤維克的問題。我們是否可以期待 VYJUVEK 在明年初獲得一些業績指引或全年營收指引？

No, because we have so many launches and the distribution you see, it will take us some time to get comfortable with how the different launches are going in different countries. So fortunately, Sami, we will not be guiding on revenue for 2026.

不，因為我們有很多產品發布，而且分銷管道也很多，所以我們需要一些時間來熟悉不同國家/地區的不同產品發布情況。所以幸運的是，薩米，我們不會發布 2026 年的營收預期。

Josh Schimmer, Cantor Fitzgerald.

喬許·施默，康托·菲茨傑拉德。

Hi. This is Alexa Deemer on for Josh Schimmer, and congrats on a great quarter. So can you please provide some more color on the contribution of US and ex-US sales in the third quarter for VYJUVEK? More specifically, what was the percentage breakdown from the US versus Germany?

你好。這裡是 Alexa Deemer，代 Josh Schimmer 為您報道，恭喜您本季表現出色。那麼，您能否更詳細地介紹 VYJUVEK 第三季美國及美國以外地區的銷售額貢獻？更具體地說，美國和德國的比例分別是多少？

Yeah. Look, the decision not to break down in this particular quarter was somewhat accounting Auditor-driven and the goal is to establish a consistent long-term practice on segment reporting. And if you follow that thought, we will be starting to break down geographies at some point in 2026. It's just that, now, it is so modest a contribution relative to the overall net revenues of the company.

是的。你看，本季不編製分部報告的決定在某種程度上是會計審計師的決定，其目標是建立一致的長期分部報告做法。如果按照這個思路，我們將在 2026 年的某個時候開始打破地域界限。只是，就目前而言，相對於公司的整體淨收入而言，這部分貢獻實在太小了。

Okay. Got it. And can you provide any more specifics on how US sales were in the second quarter versus the third quarter?

好的。知道了。您能否提供更多關於美國第二季和第三季銷售額的具體資訊？

Yeah. Definitely, I would say that the US was a bit lower than what we saw in 2Q, but not to the extent like based on my comments from the last quarter, definitely reimbursement approvals were on an uptick. And so overall, we ended up getting to a number that was higher than Q2.

是的。當然，我認為美國的情況比第二季略低，但根據我上一季的評論來看，降幅並沒有那麼大，報銷批准率肯定有所上升。因此，總的來說，我們最終得到的數字高於第二季。

Andrea Newkirk, Goldman Sachs.

安德里亞·紐柯克，高盛。

Hi. This is Morgan on for Andrea. Thank you for taking our question. With 615 reimbursement approvals, what do you attribute this growth to? Are you seeing more patient adds from the community setting? And then how are you thinking about the path to 60% penetration from here?

你好。這裡是摩根替安德里亞報道。感謝您回答我們的問題。目前已批准 615 項報銷申請，您認為這一增長歸功於什麼？您是否發現來自社區的病患增多？那麼，您認為從現在開始，如何才能達到 60% 的市場滲透率？

No. Great question, Andrea. Look, like I mentioned maybe last quarter or the one before, it was taking us a bit longer to pull through a start form as we are getting patients more out in the community and physicians who are not -- who are far away from a center of excellence.

不。安德里亞，問得好。你看，就像我上個季度或上個季度提到的那樣，我們花的時間稍微長了一些才能完成啟動表格，因為我們要讓更多的患者走出社區，而那些醫生——他們離卓越中心很遠——也走出了社區。

And by just increasing the size of the sales force, I believe we have turned that issue around. We saw some acceleration last quarter. We see a continued acceleration this quarter. Would we expect that to go forward as more reps are being trained and out into the field.

我相信，只要增加銷售團隊的規模，我們就能夠扭轉局面。上個季度我們看到了一些加速成長。本季我們看到成長動能持續加速。我們是否可以預期，隨著更多球員接受訓練並進入實戰，這種情況會繼續發展下去？

In terms of 60% market share, look, that's a number around 720. We reported 615. So we're maybe a quarter or two from hitting that number if you just do a simple math on that metric, which -- so we feel really good about the way the launch is going and how we've been able to reverse this one or two -- one quarter of deceleration in RAs.

如果以 60% 的市佔率來衡量，你看，那大約是 720 這個數字。我們報告了 615 例。所以，如果我們對這個指標進行簡單的計算，我們可能距離達到這個數字還有四分之一到兩季度的時間，因此——所以我們對發射的進展情況以及我們如何扭轉了這一到兩季度的減速趨勢感到非常滿意。

Yigal Nochomovitz, Citi.

Yigal Nochomovitz，花旗集團。

This is Joann Kim on for Yigal. Thanks for taking our question. Maybe just two quick ones for -- from us. On KB408, can you just talk a little bit about your expectations there, whether you're expecting a significant uptick in AAT with repeat dosing versus a single dose and what boost you'd be expected to see or what you want to see?

這裡是Joann Kim，為您報道Yigal。感謝您回答我們的問題。也許就我們兩個而言，就兩件小事吧。關於 KB408，您能否談談您的預期，例如，與單次給藥相比，您是否預期重複給藥能顯著提高 AAT 水平，以及您預期會看到或希望看到怎樣的提升？

Yeah. Obviously, we're expecting an uptick, but we're not particularly talking right now about how much of an uptick.

是的。顯然，我們預期會出現成長，但我們現在還沒有具體討論成長幅度。

I mean, we are doing repeat dosing of AAT -- I mean, of 408 and we'll be collecting bronch and labot samples. So that's something that's ongoing. So once -- so we will show repeat dosing and an expression of A180.

我的意思是，我們將重複給予 AAT 劑量——我是說，408 劑，並且我們將收集支氣管和實驗室樣本。所以這件事還在進行中。所以一旦—我們將展示重複給藥和 A180 的表達。

Got it. And can you speak on whether opening up more sites is also a priority for that program to continue enrolling patients, given that there are quite a number of [AATP] programs ongoing right now?

知道了。鑑於目前有許多[AATP]計畫正在進行中，您能否談談開設更多站點是否也是該計畫繼續招募病患的優先事項？

I mean, right now, we have a couple of sites that open because remember, again, these sites have to be able to do bronchoscopy. In case of 408, it's a little more complex because it's not just biopsies. They also need to take lung lavage fluids out to measure the A180 and the protein levels.

我的意思是，目前我們有幾個站點開放，因為請記住，這些站點必須能夠進行支氣管鏡檢查。對於 408 號病例，情況就比較複雜了，因為它不僅僅是活檢。他們還需要抽取肺部灌洗液來測量 A180 和蛋白質水平。

So there's only a few sites that are capable of doing this. So we have those sites. We have the patients. So hopefully, once we finish that cohort with the repeat dose administration and A180 levels, and we hope to have a meeting with the agency to potentially talk about a path forward.

所以只有少數網站能夠做到這一點。所以我們才有了這些網站。我們有病人。所以，希望在我們完成重複給藥和 A180 水平的隊列研究後，能夠與相關機構會面，並探討未來的發展方向。

There are no further questions in queue. Thank you. We've reached the end of the question-and-answer session and today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.

隊列中已無其他問題。謝謝。問答環節和今天的電話會議到此結束。現在您可以斷開電話線了，祝您有美好的一天。感謝您的參與。