Krystal Biotech Inc (KRYS) 2025 Q1 法說會逐字稿

Thank you for standing by and welcome to the Krystal Biotech first-quarter 2025 earnings call.(Operator instructions) As a reminder, today's conference is being recorded.

感謝您的支持，歡迎參加 Krystal Biotech 2025 年第一季財報電話會議。 （操作員指示）提醒一下，今天的會議正在錄製中。

I would now like to hand the conference over to your host, Stephane Paquette, Vice President of Corporate Development. Please begin.

現在，我想將會議交給主持人、企業發展副總裁 Stephane Paquette。請開始。

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

早安，感謝大家參加今天的電話會議。今天早些時候，我們發布了 2025 年第一季的財務表現。新聞稿可在我們的網站 www.krystalbio.com 上查閱。今天早些時候，我們也向美國證券交易委員會提交了 8-K 和 10-Q 收益報告。

Joining me today will be Krish Krishnan, Chairman and Chief Executive Officer; Suma Krishnan, President of Research and Development.; Jennifer McDonough, Senior Vice President of Patient Access Analytics and Operations; Christine Wilson, senior Vice President and Head of US Sales and Marketing; and Kate Romano, Chief Accounting Officer.

今天與我一起出席的還有董事長兼執行長 Krish Krishnan；研發總裁 Suma Krishnan；Jennifer McDonough，病患訪問分析與營運資深副總裁；克莉絲汀‧威爾森（Christine Wilson），資深副總裁兼美國銷售與行銷主管；以及首席會計長凱特‧羅馬諾 (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 files.

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，這些陳述是基於使用截至本次電話會議之日可用資訊做出的當前預期，並且受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結果與預測結果有重大差異。這些風險、不確定性和其他因素的描述可以在我們的 SEC 文件中找到。

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

說完這些，我將把電話轉給克里什 (Krish)。

Thank you, Stephane. Good morning, everyone. I'd like to start today by thanking the Krystal team. And we're fortunate to be in such a good position commercially, clinically and financially to help patients amidst the turbulent macro and FDA backdrop.

謝謝你，史蒂芬。大家早安。今天首先我想感謝 Krystal 團隊。我們很幸運能夠在商業、臨床和財務上處於如此有利的地位，能夠在動盪的宏觀和 FDA 背景下幫助患者。

I'd like to briefly touch on four topics Vyjuvek going global, the upcoming clinical readouts in 2025, primarily CF Alpha-1, a very exciting second ophthalmic program to treat neurotrophic keratitis that just entered the clinic and briefly discuss in the end how Krystals insulated in the current macro and FDA situation.

我想簡單談談四個主題：Vyjuvek 走向全球、2025 年即將進行的臨床讀數、主要是 CF Alpha-1、一個非常令人興奮的第二個眼科項目，用於治療剛剛進入臨床的神經營養性角膜炎，並最後簡要討論一下 Krystals 如何在當前的宏觀和 FDA 情況下保持隔離。

With the positive EC decision now behind us and the broad label that we were fortunate to receive, we're excited about launching in Europe, where the burden of finding genetically confirmed patients is much lower than it has been in the US.

現在，歐盟委員會做出了積極的決定，我們有幸獲得了廣泛的標籤，我們很高興能夠在歐洲推出這項服務，因為在歐洲，尋找基因確診患者的負擔比美國要低得多。

We would like to highlight that this is a full approval and not a conditional approval. Now that's pretty rare, and we do not have any post-approval efficacy study requirements with respect to the EU. We're planning to launch in Germany and France in Q3, while simultaneously working on preparations to move the other EU countries towards launch.

我們想強調的是，這是完全批准，而不是有條件的批准。這種情況非常罕見，而且我們對歐盟沒有任何批准後功效研究要求。我們計劃於第三季在德國和法國推出該服務，同時做好在其他歐盟國家推出該服務的準備。

With a large number of already identified deaf patients across the continent, it's my belief that the opportunity in the EU could be bigger than what the market presently anticipates. With respect to Japan, the regulatory review is progressing well, and as noted in the slide, the manufacturing inspection is now complete.

由於整個歐洲大陸已經確診了大量聾啞患者，我相信歐盟的機會可能比市場目前預期的還要大。對於日本而言，監管審查進展順利，如幻燈片中所述，製造檢查現已完成。

We expect to obtain approval in Q3 F2025 and commence treating patients in Japan as early as Q4 2025.

我們預計將於 2025 財年第三季獲得批准，並最早於 2025 年第四季開始在日本治療患者。

And now onto our 1Q results. Christine and Jan will discuss the US launch details shortly. Net revenue for the quarter came in at $88.2 million and gross margins and GTN were pretty consistent with prior quarters. As you all know, 1Q tends to be a bit light for most companies in this industry and something that's not unique to Krystal.

現在來看看我們的第一季業績。克里斯汀和簡將很快討論美國發射的細節。本季淨收入為 8,820 萬美元，毛利率和 GTN 與前幾季基本一致。眾所周知，對於這個行業的大多數公司來說，第一季的業績往往比較清淡，而 Krystal 的情況並非獨一無二。

And we saw this last year also. But more importantly, we saw patients pausing after an intensive induction period based on their individual needs. Vyjuvek is allowing patients to achieve durable wound closure, and in turn enabling patients to take control of their lives. This is a fantastic outcome for patients and for Krystal.

去年我們也看到了這種情況。但更重要的是，我們看到患者根據個人需求在強化誘導期後暫停治療。Vyjuvek 可以幫助患者達到持久的傷口閉合，進而幫助患者掌控自己的生活。對於患者和 Krystal 來說，這都是一個非常棒的結果。

These are the outcomes that will drive our long-term success, building trust and supporting the utilization of Vyjuvek in the US for patients' lifetimes. I sometimes refer to this as the tail on the drug, which we believe will be long. These success stories also activate new patients to seek out therap, build anticipation and momentum in our XU launches and enrich our access discussions overseas. This is why we pay so much attention to patient experience on Vyjuvek, and Jen will elaborate more on this.

這些成果將推動我們的長期成功，建立信任並支持美國患者終生使用 Vyjuvek。我有時將此稱為藥物的尾巴，我們相信它會很長。這些成功案例也激勵新患者尋求治療，為我們的 XU 啟動建立期待和動力，並豐富我們在海外的訪問討論。這就是我們如此重視患者使用 Vyjuvek 的體驗的原因，Jen 將對此進行更詳細的闡述。

However, in the near term, it will be important to understand that patient pausing patterns, particularly as patients come off intensive induction therapy for the first time are inherently unpredictable quarter-to- quarter. And any number we could potentially provide to estimate causing may not be repeatable in future quarters as patients come back on treatment.

然而，在短期內，重要的是要了解患者的暫停模式，特別是當患者第一次停止強化誘導治療時，其每個季度的模式本質上是不可預測的。而且，隨著患者再次接受治療，我們可能提供的任何估計數字在未來幾季都可能無法重複。

We're confident that patient ads in the US, Europe, and worldwide will continue to drive long-term growth for the years to come. But the upcoming quarters may have some waviness as we bring on new patients, and some of our existing US patients transition to a more maintenance style regiment.

我們相信，美國、歐洲和全球的患者廣告將在未來幾年繼續推動長期成長。但隨著我們引入新患者，以及我們現有的一些美國患者轉向更維持性的治療方案，未來幾季可能會出現一些波動。

It's really key to recognize that DEB is a chronic disease and Vyjuvek has a strong regulatory and a patent life. As we move into our second full year on the market, we're excited that Vyjuvek is being established as a lifelong first line therapy for wound management. And we are continually seeking out ways to further support patients' experience Vyjuvek.

認識到 DEB 是一種慢性疾病並且 Vyjuvek 具有嚴格的監管和專利期限非常重要。隨著我們進入上市的第二個整年，我們很高興 Vyjuvek 被確立為傷口管理的終身一線療法。我們一直在不斷尋找方法來進一步支持患者對 Vyjuvek 的體驗。

With respect to the clinical pipeline in 2025, we have four upcoming clinical readouts for CF, AATD, aesthetic skin conditions, and ocular lesions in depth. In CF and AATD, having already demonstrated that we can safely deliver to the lung with high rates of transduction and functional cargo expression, we're optimistic heading into molecular data updates for both programs later this year, starting with KB407 this summer.

關於 2025 年的臨床管線，我們有四份即將發布的針對 CF、AATD、美容皮膚狀況和眼部病變的深入臨床讀數。在 CF 和 AATD 中，我們已經證明可以安全地將藥物以高轉導率和功能性貨物表達輸送到肺部，我們對今年稍後這兩個項目的分子數據更新持樂觀態度，從今年夏天的 KB407 開始。

In aesthetics, with the expected KB304 readout and initiation of our KB301 Phase 2 later this year, momentum is building as we work to establish the first truly rejuvenated platform in aesthetics. We're excited to have Mark Ford join the team in support of that effort. Mark's extensive commercial experience during many years managing the Botox brand will be invaluable as we work to unlock the significant value that exists in our aesthetics pipeline.

在美學方面，隨著今年稍後 KB304 的預期讀數和 KB301 第二階段的啟動，我們致力於建立第一個真正煥發活力的美學平台，勢頭正在增強。我們很高興馬克福特加入團隊並支持這項工作。當我們努力釋放美學管道中的巨大價值時，馬克在多年管理 Botox 品牌過程中累積的豐富商業經驗將發揮無價的作用。

On KB803 designed to treat lesions, eye lesions of deaf patients, we plan to dose our first patient later this month, and when we do, we'll provide a detailed overview of study design, dosing regimen, end points, et cetera. So stay tuned. The Vyjuvek franchise globally will be further strengthened when we get KB803 approved.

對於用於治療聾啞患者眼部病變的 KB803，我們計劃在本月稍後為第一位患者進行給藥，屆時我們將提供研究設計、給藥方案、終點等的詳細概述。敬請關注。當我們獲得 KB803 批准時，Vyjuvek 的全球特許經營權將進一步加強。

Now on to our new exciting ophthalmic program that's entering the clinic. Neurotropic hepatitis is a rare degenerative corneal disease caused by nerve damage in the eye, leading to corneal epithelial defects, ulcers, and perforation. Estimates of disease prevalence vary, but typical range from 10 to 50 per 100,000.

現在我們來談談即將進入臨床的令人興奮的新眼科計畫。神經性肝炎是一種罕見的退化性角膜疾病，由眼部神經損傷引起，導致角膜上皮缺損、潰瘍和穿孔。對於此病患病率的估計各不相同，但典型的盛行率為每十萬人 10 至 50 人。

Based on results from the American Academy of Ophthalmology, Intelligent Research insight, or IRIS Registry, the prevalence is approximately 21 per 100,000 patients. Importantly, NK is associated with vision loss and in severe cases can lead to blindness. There is presently only one specific therapy available.

根據美國眼科學會、智慧研究洞察或 IRIS 註冊中心的結果，盛行率約為每 10 萬名患者 21 人。重要的是，NK 與視力喪失有關，在嚴重的情況下會導致失明。目前只有一種特定的治療方法。

Recombinant nerve growth factor oxalate. Oxalate targets underlying nerve defect and has been shown to improve healing, but must be dosed 6 times daily for eight weeks, which is highly burdensome on patients.

重組神經生長因子草酸鹽。草酸鹽針對潛在的神經缺陷，並已被證明可以促進癒合，但必須每天服用 6 次，持續 8 週，這對患者來說負擔很重。

Eye pain is also a frequently reported complication for patients receiving Oxalate compounding the issue of frequent dosing. More will discuss the exciting preclinical data and our value proposition and next steps with respect to NK shortly.

對於接受草酸鹽治療的患者來說，眼睛疼痛也是一個經常被報告的併發症，這加劇了頻繁服藥的問題。稍後我們將討論令人興奮的臨床前數據以及我們關於 NK 的價值主張和後續步驟。

Finally, in the current environment, we thought it was important that investors understand how insulated Krystal is from external turbulence. All of our commercial and pipeline products are manufactured in the US. All Krystal IP composition of matter, method of use, formulation are also housed in the US, avoiding any kind of complications in our home market. I also want to point out we do not utilize any kind of transfer pricing with respect to Vyjuvek sales in the US.

最後，在當前環境下，我們認為讓投資者了解 Krystal 如何免受外部動盪的影響非常重要。我們所有的商業和管道產品均在美國製造。Krystal IP 的所有物質組成、使用方法和配方也都在美國，從而避免了在本土市場出現任何複雜情況。我還想指出，對於 Vyjuvek 在美國的銷售，我們不會採用任何形式的轉讓定價。

On the financial side, as many of we run a tight ship. We've had seven quarters of profitable EPS, and as I've mentioned before, the expected revenue from Vyjuvek far exceeds our anticipated operating expense for the next few years. This financial stability gives us the optionality to maximize shareholder value at the right time.

在財務方面，我們中的許多人管理得很嚴格。我們的每股盈餘已連續七個季度獲利，而且正如我之前提到的，Vyjuvek 的預期收入遠遠超過我們未來幾年預期的營運費用。這種財務穩定性使我們能夠在適當的時候實現股東價值最大化。

And finally, with our upcoming XE launches, we're well on our way to build a global geographically diversified business, limiting exposure to regulatory or trade dynamics in any single market and allowing us to continue forward in our mission of being a lifelong first line therapy for our patients and delivering long term profitable growth.

最後，隨著我們即將推出的 XE，我們正在順利建立全球地理多元化業務，限制對任何單一市場監管或貿易動態的影響，並使我們能夠繼續履行我們的使命，即成為患者終身的一線治療藥物並實現長期盈利增長。

I'll now hand it off to Jennifer to share more color on US launch dynamics.

現在我將把話題交給珍妮佛，讓她分享更多關於美國發射動態的資訊。

Thank you, Krish. I am happy to share continued growth in the number of US patients gaining access to Vyjuvek with the number of patients with reimbursement approvals exceeding 540 as of April 2025. The access landscape across the United States remains very strong. We continue to maintain effectively full nationwide commercial and Medicaid coverage. We are seeing no friction with re-authorizations, all have either been approved or in processed and changes in insurance that occurred in the first quarter were also processed smoothly with timelines in line with industry standards.

謝謝你，克里什。我很高興地告訴大家，獲得 Vyjuvek 治療的美國患者數量持續增長，截至 2025 年 4 月，獲得報銷批准的患者數量已超過 540 人。美國各地的接取情勢依然十分強勁。我們將繼續有效地維持全國範圍內的商業和醫療補助覆蓋。我們發現重新授權沒有任何摩擦，所有授權都已獲得批准或正在處理中，第一季度發生的保險變化也按照符合行業標準的時間表順利處理。

Reimbursement approvals were again similar to recent quarters with roughly even splits between commercial and government plans. We also continue to see approvals across the entire dead population, including patients of all ages with either dominant or recessive forms of the disease.

報銷批准情況與最近幾季類似，商業計劃和政府計劃的報銷比例大致均等。我們也繼續看到整個死亡人群的批准，包括患有顯性或隱性疾病的所有年齡層的患者。

Patient preference for at-home administration is again effectively unchanged, with 97% of treatments occurring in the home setting. As Krish mentioned, as patients are experiencing real world treatment success and wound closure, we are seeing meaningful treatment pauses and maintenance treatment.

患者對在家治療的偏好實際上並沒有改變，97% 的治療都在家中進行。正如克里什所提到的，隨著患者在現實世界中經歷治療成功和傷口閉合，我們看到了有意義的治療暫停和維持治療。

Treatment success is a fantastic outcome not only for dead patients, but also for Krystal. Successful Vajuvek brings brings about patients and caregivers recognition that Vaijuvek is reliable and effective in treating and retreating wounds, which will change the course of the disease and enable patients to take control of their lives.

治療成功不僅對死去的病人來說是一個美妙的結果，對 Krystal 來說也是如此。Vajuvek 的成功讓患者和照護者認識到 Vaijuvek 在治療和恢復傷口方面是可靠和有效的，這將改變疾病的進程並使患者能夠掌控自己的生活。

In turn, successful outcomes will result in lifetime by Vaijuvek usage support better understanding of the benefits of lifetime by Vaijuvek usage in the medical community, and encourage new de patients to seek out usage of Vaijuvek, all of which will drive Krystal's long-term success.

反過來，成功的結果將使終生使用 Vaijuvek 有助於醫學界更好地理解終生使用 Vaijuvek 的好處，並鼓勵新的患者尋求使用 Vaijuvek，所有這些都將推動 Krystal 的長期成功。

The benefits of patients' success Vaijuvek is why we pay so much attention to patient experience. Our commitment to patients via Krystal Connect goes far beyond simply treating patients. Because Vaijuvek is a lifelong therapy. Our goal is to support. Patients so that they integrate treatments into their normal wound care routines. And because wound closure and wound durability is personalized, we strive to build long-term partnerships with each patient and their family.

患者成功的好處 Vaijuvek 就是我們如此重視患者體驗的原因。我們透過 Krystal Connect 對患者的承諾遠遠超出了簡單的治療。因為 Vaijuvek 是一種終身療法。我們的目標是支持。患者，以便他們將治療融入正常的傷口護理程序中。由於傷口閉合和傷口耐久性是個人化的，我們努力與每位患者及其家人建立長期的合作關係。

Our goal is t support their success at every stage of life and throughout their treatment journey helping them heal and live more fully. Treatment persistence is a priority education topic for our patients, their caregivers, and their prescribers, and is continually reinforced by our patient support team at Krystal Connect. We have invested in educational campaigns drawing on real world outcomes to emphasize the importance of regular treatment and the potential links between wound closure and known complications of DEB.

我們的目標是支持他們在人生的每個階段和整個治療過程中取得成功，幫助他們康復並更充實地生活。治療堅持是我們針對患者、他們的照護者和處方醫生的優先教育主題，而 Krystal Connect 的病患支援團隊不斷強化這個主題。我們投資了借鑒現實世界成果的教育活動，以強調定期治療的重要性以及傷口閉合與已知 DEB 併發症之間的潛在關聯。

We also work. Closely with our patients, setting expectations that Vaijuvek is a lifelong therapy as they manage their wounds, so patients are well prepared to define and meet their treatment goals and ultimately get the most from their Vaijuvek treatments.

我們也工作。與我們的患者密切合作，設定 Vaijuvek 是一種終身治療方法，可以幫助患者管理傷口，因此患者可以做好充分準備來確定和實現他們的治療目標，並最終從 Vaijuvek 治療中獲得最大收益。

This is all in addition to our comprehensive Krystal Connect services that include onboarding education, periodic check-ins and live and virtual patient programs, all of which are designed to maximize engagement to build strong trust-based relationships for the long term.

除此之外，我們還提供全面的 Krystal Connect 服務，包括入職教育、定期檢查以及現場和虛擬患者計劃，所有這些服務旨在最大限度地提高參與度，以建立長期牢固的信任關係。

With our Krystal Connect team, we look forward to working lockstep with patients as they integrate by Vaijuvek into their first. line wound care routine throughout their lives, helping them reduce the disease burden and improve their quality of life.

我們期待與 Krystal Connect 團隊攜手合作，幫助患者將 Vaijuvek 融入他們的第一階段治療中。定期進行傷口護理，幫助他們減輕疾病負擔，並改善生活品質。

I will now hand it off to Christine.

我現在將其交給克里斯汀。

Thank you, Jen. With the steady stream of new patients over the past few months, we continue to make progress towards our goal of making Vaijuvek available to as many dead patients as possible across the US. We have the privilege of hearing directly from patients, giving us valuable insights into the diverse way this condition impacts daily life.

謝謝你，Jen。隨著過去幾個月新患者的不斷湧入，我們繼續朝著讓盡可能多的美國死者能夠使用 Vaijuvek 的目標邁進。我們有幸直接聽取患者的意見，這讓我們對這種疾病對日常生活的多種影響有了寶貴的見解。

Each patient's journey is unique. For example, one longtime patient believed that death had a minimal impact on his career or quality of life until he began treatment with Vaijuvek. After experiencing wound improvement, he realized how much pain he had simply learned to live with. Stories like this are exactly why our work matters. These personal experiences are a key element of our consumer communication strategy.

每位患者的經驗都是獨一無二的。例如，一位長期患者認為，在開始接受 Vaijuvek 治療之前，死亡對他的職業生涯或生活品質的影響很小。在傷口好轉後，他意識到自己已經學會了忍受多少痛苦。像這樣的故事正是讓我們的工作如此重要的原因。這些個人經驗是我們消費者溝通策略的關鍵要素。

Importantly, feedback from healthcare providers has been clear. Vaijuvek is making a meaningful impact across every segment of the DEB patient population. This includes both RE and DEB patients ranging from mild to severe regardless of age.

重要的是，來自醫療保健提供者的回饋非常明確。Vaijuvek 正在對 DEB 患者群體的各個部分產生深遠的影響。這包括 RE 和 DEB 患者，無論年齡大小，病情從輕度到重度不等。

While each patient's path is different, physicians consistently report durable wound healing and positive outcomes. It's evident that Vaijuvek is transforming care in a powerful and measurable way. In the last quarter, we observed a slowdown compared to the previous quarters in the number of reimbursement approvals, and this is directly tied to the pace of patient start forms we received in 1Q.

雖然每個病人的情況都不同，但醫生一致報告傷口癒合持久且結果積極。顯然，Vaijuvek 正在以強大且可衡量的方式改變護理。在上個季度，我們發現報銷批准數量與前幾季相比有所放緩，這與我們在第一季度收到的患者開始表格的速度直接相關。

We're entering a phase where the patients we aim to reach are further embedded in their communities, often under the care of HCPs who may have limited experience with DEB and in understanding the importance of treatment and who see their patients less frequently.

我們正進入一個階段，我們想要接觸的患者已經進一步融入他們的社區，通常由對 DEB 經驗有限、不了解治療重要性且較少見患者的 HCP 負責。

Our reps are dealing with longer interaction times with each physician to meet and educate and pull through a patient start form. We started to address this in 1Q by enhancing the size of our field sales team and bolstering our field activities.

我們的代表需要與每位醫生進行更長的互動時間，以便會面、教育並完成患者開始表格。我們從第一季開始解決這個問題，擴大了現場銷售團隊的規模，並加強了現場活動。

In addition, we continue to elevate our direct to patient marketing tactics through social media and patient education events through our advocacy partners. We are soon launching our Vaijuvek voices program that will allow potential patients to speak with Vaijuvek patient and caregiver ambassadors to learn about their experience and success with Vaijuvek, how they've incorporated Vaijuvek into their wound care routine, and the impact it's made on their lives.

此外，我們繼續透過社群媒體和倡導合作夥伴開展的患者教育活動來提升我們直接面向患者的行銷策略。我們即將推出 Vaijuvek 之聲計劃，該計劃將允許潛在患者與 Vaijuvek 患者和護理人員大使交談，了解他們使用 Vaijuvek 的經驗和成功經驗、他們如何將 Vaijuvek 融入他們的傷口護理日常中，以及它對他們生活的影響。

We believe these initiatives will help us to overcome this temporary slowdown in the next few months. While the pace of start form slowed in 1Q, we remain confident in the total opportunity in the US, starting with the 1,200 diagnosed DEB patients. Our near term claims data and field insights continue to show that there is still a large group of already diagnosed DEB patients we have yet to reach and start on by (inaudible).

我們相信這些措施將幫助我們在未來幾個月克服這種暫時的放緩。儘管第一季開始的速度有所放緩，但我們仍然對美國的整體機會充滿信心，首先是 1,200 名確診的 DEB 患者。我們的近期索賠數據和實地洞察繼續表明，仍有一大批已確診的 DEB 患者尚未接觸並開始（聽不清楚）。

With our growing toolkit of real world experiences and powerful success stories from early adopters, we are confident in the strong growth potential ahead. At the time of launch, we set for ourselves an ambitious goal to obtain 60% market share in two years. Based on the number of reimbursement approvals over the last two quarters, we now expect it to take a few extra months to achieve that target.

憑藉我們不斷成長的實際經驗和早期採用者的成功案例，我們對未來強勁的成長潛力充滿信心。在產品推出時，我們為自己設定了一個雄心勃勃的目標，在兩年內獲得 60% 的市場份額。根據過去兩個季度的報銷批准數量，我們預計還需要幾個月的時間才能實現該目標。

With that being said, without question, the Vaijuvek's launch has gone extremely well to date, and we are confident that with the efforts we are putting in place, that momentum will continue. Our mission remains unchanged to support the dead community and help all DEB patients regardless of the severity of their disease and those who may believe a treatment is out of reach. Understand that Vaijuvek is safe, effective, and easy to use treatment to dramatically improve the quality of their life. We are confident in the opportunity ahead.

話雖如此，毫無疑問，Vaijuvek 的發布迄今為止進展非常順利，我們相信，透過我們的努力，這種勢頭將會持續下去。我們的使命始終不變，那就是支持死者群體，幫助所有 DEB 患者，無論其病情嚴重程度如何，也無論那些患者是否認為無法接受治療。了解 Vaijuvek 是一種安全、有效且易於使用的治療方法，可顯著改善他們的生活品質。我們對未來的機會充滿信心。

Now I will hand it to Suma.

現在我將把它交給 Suma。

Thank you, Christine. Before getting into our clinical pipeline, I want to take a moment to highlight two publications that came out just last month in support of Vyjuvek, including our open-label extension study results.

謝謝你，克里斯汀。在介紹我們的臨床流程之前，我想花點時間重點介紹一下上個月剛發布的兩篇支持 Vyjuvek 的出版物，包括我們的開放標籤擴展研究結果。

Our OLE study, published in the American Journal of Clinical Dermatology, includes findings from an expanded study population across all ages and ethnicities with a medium Vyjuvek exposure of over 500 days.

我們的 OLE 研究發表在《美國臨床皮膚病學雜誌》上，其中包括來自各個年齡和種族的擴大研究人群的研究結果，這些人群平均 Vyjuvek 暴露時間超過 500 天。

These data clearly demonstrated that long-term use of Vyjuvek is safe and delivers durable wound closure with clinical benefits compounding over time. Dramatic improvements were also reported for patients with large and chronic wounds, reinforcing that wounds of any size can benefit from Vyjuvek therapy.

這些數據清楚地表明，長期使用 Vyjuvek 是安全的，並且可以實現持久的傷口閉合，並且臨床益處會隨著時間的推移而增加。報導稱，患有大面積慢性傷口的患者也得到了顯著改善，這進一步證明，任何大小的傷口都可以從 Vyjuvek 療法中受益。

The second publication in the British Journal of Dermatology describes a case of Vyjuvek therapy successfully promoting wound healing following surgical excision of a large squamous cell carcinoma lesion in a recessive DEB patient.

《英國皮膚病學雜誌》上的第二篇出版物描述了 Vyjuvek 療法成功促進隱性 DEB 患者手術切除大型鱗狀細胞癌病變後傷口癒合的病例。

Not only did the authors report that this patient achieved closure of large wound over 100 centimeters square in size within a few months, it remained closed at 4 and 10-month follow-up. These data underscore the consistent clinical benefits provided by Vyjuvek and supports its use in the routine management of SCC.

作者不僅報告說，該患者超過 100 平方厘米的大傷口在幾個月內就閉合了，而且在 4 個月和 10 個月的隨訪中傷口仍然保持閉合狀態。這些數據強調了 Vyjuvek 提供的一致臨床益處，並支持其在 SCC 的常規管理中使用。

Both these studies reinforce the versatility of Vyjuvek in treating wounds of all types and sizes. The benefits of Vyjuvek therapy for the treatment of large and chronic wounds in particular are showcased here, with multiple examples of large wound healing among our OLE participants.

這兩項研究都證實了 Vyjuvek 在治療各種類型和大小的傷口方面的多功能性。這裡展示了 Vyjuvek 療法對治療大型和慢性傷口的益處，並列舉了我們的 OLE 參與者中多個大型傷口癒合的例子。

On the left, we have a case where at the start of the OLE, the patient's entire upper back was an open wound. With regular treatment, we saw steady and continual improvements approaching complete closure at the one-year mark.

左側有一個病例，在 OLE 開始時，患者的整個上背部都是開放性傷口。透過定期治療，我們看到了穩定和持續的改善，一年後接近完全治癒。

On the right, we have images from the patient that started in our Phase 3 study and continued on the OLE. Here we can see not only compelling initial wound healing outcomes with the context of the Phase 3, but also further improvements over the course of the OLE, again, reinforcing Vyjuvek versatility and the potential benefits of sustained long-term therapy.

右側是我們在第 3 階段研究中開始並在 OLE 上繼續進行的患者影像。在這裡，我們不僅可以看到第 3 階段令人信服的初始傷口癒合結果，還可以看到 OLE 過程中的進一步改善，再次強化了 Vyjuvek 的多功能性和持續長期治療的潛在益處。

We are excited for more patients to access and benefit from Vyjuvek therapy as we progress in our launch in the US and worldwide. Shifting focus to our pipeline, we are now rapidly approaching a critical juncture for our lung program. Thanks to the support of the CFS Foundation, we are on track to report molecular data in CF patients this summer, followed by additional molecular data in AATD patients before year end.

隨著我們在美國和全球範圍內推進 Vyjuvek 療法的推廣，我們很高興能有更多患者能夠接受並受益於該療法。將焦點轉移到我們的管道上，我們現在正快速接近肺部項目的關鍵時刻。感謝 CFS 基金會的支持，我們將在今年夏天報告 CF 患者的分子數據，並在年底前報告 AATD 患者的更多分子數據。

With initial KB408 data already demonstrating that we can deliver safely functional genetic cargo to the airways of the lung, we look forward to validating the breadth of our platform for lung delivery in a broader population of CF and AATD patients, and then moving quickly to repeat dosing.

初步的 KB408 數據已經證明我們可以將功能性基因貨物安全地運送到肺部氣道，我們期待在更廣泛的 CF 和 AATD 患者群體中驗證我們平台的肺部輸送廣度，然後迅速進行重複給藥。

At the same time, we are pushing ahead our development efforts in the eye. Our lead ophthalmology program and eye-drop formulation of B-VEC, we refer to as KB803, is on track for registrational study start later this month.

同時，我們正大力推動眼科發展工作。我們的主要眼科計畫和 B-VEC 眼藥水配方（我們稱之為 KB803）將於本月晚些時候開始註冊研究。

Having already seen a dramatic improvement in the patient treated with B-VEC eye-drops under compassionate use, we are excited about the prospect of delivering more comprehensive benefits to DEB patients with KB803.

我們已經看到在同情用藥下使用 B-VEC 眼藥水治療的患者病情有了顯著改善，我們對 KB803 為 DEB 患者帶來更全面益處的前景感到興奮。

With our IND cleared, approximately 50 patients in our natural history study, and potential to roll over into our Phase 3, we continue to expect a top line data readout before year end. Additional details on the study design and endpoints will be disclosed at the time we dose our first patient this month.

隨著我們的 IND 獲得批准，大約有 50 名患者參與了我們的自然史研究，並且有可能進入第 3 階段，我們仍然預計在年底前可以獲得頂線資料。我們將在本月為第一位患者進行給藥時披露有關研究設計和終點的更多細節。

We are excited to announce today our second clinical stage ophthalmology program KB801 for the treatment of neurotrophic keratitis. Until now, rapid clearance rate and high turnover in the front of the eye have severely limited the therapeutic potential of biologics and gene therapies for the treatment of corneal dystrophies and other front of the eye diseases.

今天我們很高興地宣布我們的第二個臨床階段眼科計畫 KB801，用於治療神經營養性角膜炎。到目前為止，眼前部的快速清除率和高週轉率嚴重限制了生物製劑和基因療法治療角膜營養不良和其他眼前部疾病的治療潛力。

With our redosable vector platform already shown to be safe in the clinic, we have an opportunity to drive sustained expression of therapeutic biological payloads with a simple eye drop application. KB801 leverages these exact features.

我們的可重複使用載體平台已在臨床上證明是安全的，我們有機會透過簡單的滴眼液應用來推動治療生物有效載荷的持續表達。KB801 正是利用了這些特性。

Developed using a proprietary HSV-1 vector platform, KB801 is an eye-drop designed to deliver two (inaudible) copies to the corneal epithelium and enable sustained local production of nerve growth factor with the therapeutic goal of maintaining more consistent nerve growth factor levels and potential healing advantages in the NK patients, all while also significantly reducing the treatment burden for patients when compared to the currently approved recombinant protein dosing regimen of six times per day.

KB801 採用專有的 HSV-1 載體平台開發，是一種眼藥水，旨在將兩個（聽不清）副本輸送到角膜上皮，並實現神經生長因子的持續局部產生，治療目標是維持更一致的神經生長因子水平和 NK 患者的潛在癒合優勢，同時與目前批准的每天六次重組蛋白給藥方案相比，還可顯著減輕患者的治療負擔。

We recently presented preclinical data on KB801 at ARVO. The presentation has been filed as an 8-K. These data clearly demonstrated that KB801 is able to efficiently transduce corneal epithelial cells in vitro and in vivo, leading to sustained NGF production in front of the eye.

我們最近在 ARVO 上展示了 KB801 的臨床前數據。該簡報已作為 8-K 表格提交。這些數據清楚地表明，KB801 能夠在體外和體內有效地轉導角膜上皮細胞，導致眼前持續產生 NGF。

On the back of this data and with recently cleared IND, we are on track to dose the first patient with KB801 in a Phase 1, 2 study later this month. Head-to-head data comparing the pharmacokinetics of KB801 to the recombinant human NGF are shown here.

基於這些數據以及最近批准的 IND，我們將於本月稍後在第 1、2 階段研究中為第一位患者註射 KB801。這裡顯示了 KB801 與重組人 NGF 的藥物動力學對比數據。

Mouse corneas were wounded to approximate the corneal lesions that are observed in the neurotropic keratitis and then treated with a single dose of either KB801 or dilution factor matched recombinant human NGF.

將小鼠角膜弄傷，使其接近神經性角膜炎中觀察到的角膜病變，然後以單劑量 KB801 或稀釋因子匹配的重組人 NGF 進行治療。

Eyes were then collected at the specified time point for assessment of NGF levels by ELISA. Whereas detectable NGF levels dropped rapidly after administration of a recombinant protein, a single dose of KB801 resulted in sustained expression peaking at 24 hours at levels higher than those achieved with recombinant protein and remaining elevated for many days thereafter.

然後在指定的時間點收集眼睛，透過 ELISA 評估 NGF 水平。儘管在施用重組蛋白後可檢測到的 NGF 水平迅速下降，但單劑量 KB801 導致持續表達在 24 小時時達到峰值，其水平高於重組蛋白所達到的水平，並且在此後的許多天裡保持升高。

In a follow-up study comparing a single dose head-to-head with six doses of recombinant protein and approximation of the current label treatment regimen of Oxervate, we found that within 15 minutes of the sixth recombinant protein dose, NGF levels were higher in KB801-treated eyes and remained elevated through 24 hours after last dose.

在一項後續研究中，我們將單劑量重組蛋白與六劑量重組蛋白以及近似於 Oxervate 的當前標籤治療方案進行了對比，我們發現在第六次重組蛋白劑量的 15 分鐘內，KB801 治療眼睛中的 NGF 水平較高，並且在最後一次劑量後的 24 小時內保持升高。

Both of these results in a relatively stringent mouse model gives us strong conviction in the potential of KB821 to achieve and maintain therapeutic NGF levels with infrequent dosing. Based on the preclinical data generated to-date, as well as previously generated preclinical and clinical data with ophthalmic B-VEC, last month, the FDA cleared our IND to evaluate KB801 in NK patients.

在相對嚴格的小鼠模型中獲得的這兩項結果都讓我們堅信 KB821 具有以不頻繁給藥達到並維持治療性 NGF 水平的潛力。根據迄今為止產生的臨床前數據以及先前使用眼科 B-VEC 產生的臨床前和臨床數據，上個月，FDA 批准了我們的 IND 以評估 KB801 對 NK 患者的作用。

Study preparations are underway, and we expect to dose the first patient in a 2:1 randomized, placebo-controlled, blinded, multicenter Phase 1 study in moderate to severe NK patients later this month. Additional details on the study design and endpoints will be disclosed at the time, we dose the first patient.

研究準備工作正在進行中，我們預計將於本月稍後在針對中度至重度 NK 患者的 2:1 隨機、安慰劑對照、盲法、多中心 1 期研究中對第一位患者進行給藥。當我們對第一位患者進行給藥時，將揭露有關研究設計和終點的更多細節。

With upcoming readouts in the lung, eyes, and aesthetics, we remain on track to meet our ambitious 2025 plans, all while adding our new clinical stage program, KB801. We look forward to delivering our first molecular readout in CF this summer, followed by readouts for KB408 in AATD, KB803 in ocular, DEB, and KB304 in aesthetics before year-end.

隨著肺部、眼睛和美學方面即將獲得的讀數，我們仍有望實現雄心勃勃的 2025 年計劃，同時增加我們的新臨床階段計劃 KB801。我們期待今年夏天在 CF 中提供我們的第一個分子讀數，然後在年底之前提供 AATD 中的 KB408、眼科中的 KB803、DEB 和美學中的 KB304 的讀數。

Finally, you all probably saw the announcement regarding our ASCO presentation. Dr. Ma Weiss, Chairman of the Cancer Institute of Cleveland Clinic, will present efficacy and safety data from in-haled KB707, a novel HSV-based immunotherapy as a monotherapy in patients with solid tumor malignancies affecting the lung.

最後，大家可能都看到了有關我們 ASCO 演示的公告。克利夫蘭診所癌症研究所所長馬維斯博士將介紹吸入式 KB707 的療效和安全性數據，KB707 是一種基於 HSV 的新型免疫療法，作為單一療法治療影響肺部的實體瘤惡性腫瘤患者。

We are excited about this upcoming announcement and cannot wait to share this data with you. This update will build on the interim data readout we provided at the end of last year, in which we saw early evidence of monotherapy activity in patients in non-small cell lung cancer, including an ORR of 27%.

我們對即將發布的公告感到非常興奮，迫不及待地想與您分享這些數據。此次更新將以我們去年年底提供的中期數據讀數為基礎，在該數據中我們看到了單一療法對非小細胞肺癌患者有效的早期證據，包括 27% 的 ORR。

We also continue to enroll in both our intratumoral and in-haled KB707 clinical studies. We believe that we have only begun to tap in the opportunity that exists with HSV-1-based gene delivery and are excited about the work ahead.

我們也持續參與腫瘤內和吸入性 KB707 臨床研究。我們相信，我們才剛開始挖掘基於 HSV-1 的基因傳遞所帶來的機遇，並對未來的工作感到興奮。

With that, I would like to turn the call to Kate.

說到這裡，我想把電話轉給凱特。

Thank you, Suma, and good morning, everyone. I'd like to provide a few highlights from our Q1 financial results that were reported in our press release earlier today. As Krish noted, our net product revenue for Vyjuvek was $88.2 million for the first quarter of 2025. This marked meaningful growth from the first quarter of 2024, up 95% from the prior year.

謝謝你，蘇瑪，大家早安。我想提供我們今天早些時候在新聞稿中報告的第一季財務業績的一些亮點。正如 Krish 所指出的，2025 年第一季度，Vyjuvek 的淨產品收入為 8,820 萬美元。這標誌著 2024 年第一季實現了有意義的成長，比前一年增長了 95%。

Cost of goods sold was $5 million compared to $2.4 million in the prior year's first quarter, and gross margin remained relatively consistent at 94% in 1Q 2025. Research and development expenses were $14.3 million compared to $11 million in the prior year, primarily due to an increase in personnel-related expenses, including stock compensation expense, clinical development costs, and increased manufacturing costs related to our product candidates.

銷售成本為 500 萬美元，而去年同期第一季為 240 萬美元，2025 年第一季毛利率保持相對穩定，為 94%。研發費用為 1,430 萬美元，而去年同期為 1,100 萬美元，主要原因是人員相關費用增加，包括股票薪酬費用、臨床開發成本以及與我們候選產品相關的製造成本增加。

General and administrative expenses were $32.7 million compared to $26.1 million in the prior year, primarily due to an increase in personnel-related expenses, including stock compensation expense, as well as charitable contributions and increased professional service expenses. Operating expenses included non-cash stock-based compensation of $13.5 million as compared to $9.3 million in the prior year's first quarter.

一般及行政開支為 3,270 萬美元，而上年同期為 2,610 萬美元，主要原因是人員相關開支增加，包括股票薪資開支，以及慈善捐款和專業服務開支增加。營運費用包括 1,350 萬美元的非現金股票薪酬，而去年同期第一季為 930 萬美元。

Net income for the quarter was $35.7 million, which represented $1.24 per basic and $1.20 per diluted share. In closing, we ended Q1 well capitalized with $765.3 million in total cash plus investments, noting quarterly growth in our overall cash and investments position and putting us in excellent shape to execute on our European launch and to invest in our significant clinical programs this year.

本季淨收入為 3,570 萬美元，即每股基本收入 1.24 美元，每股稀釋收入 1.20 美元。最後，我們在第一季結束時擁有充足的資金，總現金和投資為 7.653 億美元，我們的整體現金和投資狀況實現了季度增長，這為我們今年在歐洲的上市和重要臨床項目的投資做好了充分準備。

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. You heard from Jen that the successes that patients are achieving today, characterized by pauses, drive our success tomorrow and are the tailwinds that will support long-term utilization, further market adoption, and penetration in the US and abroad, and productive access discussions with ex-US payers.

謝謝，凱特。您從 Jen 那裡聽說，患者今天所取得的成功（以停頓為特徵）推動著我們明天的成功，並且是支持長期利用、進一步市場採用和在美國和國外滲透以及與美國以外付款人進行富有成效的准入討論的順風。

You heard from Christine that our reps are dealing with longer interaction times with each physician, and we've already started to address this in 1Q by enhancing the size of our field sales team.

您從克里斯汀那裡聽說，我們的銷售代表與每位醫生的互動時間更長，我們已經在第一季開始透過擴大現場銷售團隊的規模來解決這個問題。

That said, with strong patient outcomes demonstrating the value of regular Vyjuvek therapy, our conviction on the total market opportunity and the long-term profitability of Vyjuvek franchise have only been strengthened.

儘管如此，患者的良好治療結果證明了定期 Vyjuvek 治療的價值，我們對 Vyjuvek 特許經營的整體市場機會和長期盈利能力的信心得到了加強。

You heard from Suma on the upcoming readouts and productive clinical pipeline, and Kate confirmed the strength of our financial situation. All of the above give us plenty of ammunition to deliver on shareholder value in 2025.

您從 Suma 那裡聽說了即將發布的讀數和富有成效的臨床流程，Kate 證實了我們的財務狀況強勁。以上所有因素都為我們在 2025 年實現股東價值提供了充足的彈藥。

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

感謝您的聆聽，現在我想開始問答環節。

Certainly, at this time we will be conducting a question and answer session.

當然，這次我們將進行問答環節。

(Operator instructions)

（操作員指示）

Alec Stranahan, Bank of America.

亞歷克·斯特拉納漢，美國銀行。

Hey, guys. Thanks for taking our questions. Just a couple from us. First, on the Vyjuvek sales in 1Q, curious how insurance changes or any other effects sort of impacted the trends you're seeing in 1Q? And is it fair to maybe model a bit of a rebound at 2Q, just given the trends we saw last year? And then, I've got a follow-up.

嘿，大家好。感謝您回答我們的問題。距離我們只有幾對。首先，關於第一季 Vyjuvek 的銷售情況，您是否好奇保險變化或任何其他影響對您在第一季度看到的趨勢有何影響？僅從我們去年看到的趨勢來看，預測第二季會出現小幅反彈是否公平？然後，我有一個後續行動。

Look, there was an impact from insurance changes. It wasn't as prominent as it was last year because we already have a J-code in place, but this is something we expect every year, and especially those with insurance changes, there's a time lag, and that part of it makes it up in 2Q, makes up that component of it, catches up.

看起來，保險變化確實產生了影響。它不像去年那麼突出，因為我們已經有一個 J 代碼，但這是我們每年都會遇到的情況，特別是那些有保險變化的情況，存在時間滯後，其中的一部分會在第二季度彌補，彌補其中的一部分，然後趕上來。

Okay, that makes sense. And then it looks like the new reimbursement approvals is slowing down as well. Since the percent access determinations appears stable at 97%. Is this sort of a natural shrinking in the addressable population, or should we maybe expect some swings on this number as well? Thanks a lot.

好的，這很有道理。而且看起來新的報銷審批也正在放緩。由於訪問百分比確定似乎穩定在 97%。這是否是可尋址人口的自然萎縮，或者我們是否應該預期這個數字也會出現一些波動？多謝。

No, look, I was clear in my opening conversation that, look, we have no hesitation, no questions about the total market opportunity, which we defined as about 1,200 identified patients and a total prevalence of close to 3,000 in the US. But as Christine mentioned, it is taking longer for our reps to pull through a patient start form, especially as they get deeper into the community. And so to address that, we have been, we already started increasing the size of the commercial effort to address that slowness.

不，你看，我在開場白中就明確表示，你看，我們毫不猶豫，對整個市場機會沒有任何疑問，我們將其定義為約 1,200 名已確診患者和美國接近 3,000 的總患病人數。但正如克里斯汀所提到的，我們的代表需要更長的時間來完成患者開始表格，特別是當他們深入社區時。為了解決這個問題，我們已經開始加大商業努力的規模來解決這個緩慢問題。

Okay, makes sense. Yes, thanks for the color and congrats on the continued progress.

好的，有道理。是的，感謝您的顏色，並祝賀您不斷取得進步。

Thanks, Alec.

謝謝，亞歷克。

Roger Song, Jefferies.

傑富瑞 (Jefferies) 的羅傑宋 (Roger Song)。

Great. Thanks for the update and taking all questions. A couple questions from us as well. The first one is related to the compliance. Totally understand those patients are doing great and then following treatments as they walk close and understanding the fluctuation of the situation. Just curious about what's your updated thoughts around the long-term compliance rate going to look like?

偉大的。感謝您的更新和回答所有問題。我們也有幾個問題。第一個與合規性有關。完全理解那些病人的情況很好，並且在他們走近時接受治療並了解情況的波動。我只是好奇您對長期合規率的最新想法是什麼？

And also given that you will -- you already treat all the patients for a year, do you have any patients with the restarting the Vyjuvek? How does the experience look like in terms of the timing of the restart and then what's the duration of the use of the Vyjuvek as they restart? Thank you.

而且考慮到您已經為所有患者治療了一年，是否有患者願意重新開始使用 Vyjuvek？就重啟時間而言，體驗如何？重啟後 Vyjuvek 的使用長度是多久？謝謝。

Look, with respect to compliance, Roger, when we launched about, I don't know, 18 months ago, we had expected that we'd be at 50% compliance, 18 months post-launch. We're not there. We're way ahead, like as you noted. But as the mix of RDEB and DDEB patients get closer and closer to each other, we expect the compliance to hit 50% in the long term. And it's tough to predict when that would happen, but it's definitely heading in that direction, but a lot slower than we had anticipated it to be. And on your second question,

你看，關於合規性，羅傑，當我們大約在 18 個月前推出時，我們預計在推出 18 個月後合規率將達到 50%。我們還沒到那裡。正如您所說，我們已經遙遙領先。但隨著 RDEB 和 DDEB 患者的比例越來越接近，我們預期長期依從性將達到 50%。很難預測什麼時候會發生這種情況，但它肯定朝著這個方向發展，只是比我們預期的要慢得多。關於你的第二個問題，

Which was specific, I think, to pauses and restarts, as I mentioned in the script, it is very individualized for every patient. Wound closure and wound durability is just very specific to patients and where their wounds are located and the type of friction and some other outside influences that do impact the behavior of the wounds and the reopening. But, yes, we definitely are seeing patients pause and then come back as their wounds all reappear or reopen or other wounds are created. So, yes, so we are seeing all that behavior.

我認為，對於暫停和重新開始來說，這是具體的，正如我在腳本中提到的那樣，它對每個病人來說都是非常個性化的。傷口閉合和傷口耐久性與患者及其傷口的位置、摩擦類型以及一些其他影響傷口行為和重新開放的外部因素有關。但是，是的，我們確實看到病人停下來然後又回來，因為他們的傷口全部重新出現或重新裂開或產生了其他傷口。是的，我們看到了所有這些行為。

I mean, which is a good thing. I mean, this is what we want to see in these patients. What we can see is our treatment is effective, it's durable. And as you know, these patients, even if they're durable, as Jen mentioned, sometimes they get more confident and they do more activities because of wound healing. And sometimes that can result in created wounds because of those additional activities. And then obviously they're so used to getting these wounds treated, they signal that they need the drug again. So the flexibility really does help these patients, the drugs

我的意思是，這是一件好事。我的意思是，這就是我們希望在這些病人身上看到的。我們可以看到我們的治療是有效的，而且是持久的。如你所知，這些病人，即使他們很堅強，正如 Jen 所提到的，有時他們會因為傷口癒合而變得更有信心，做更多的活動。有時這些額外的活動可能會造成傷口。然後顯然他們已經習慣了治療這些傷口，他們發出信號說他們再次需要這種藥物。所以靈活性確實對這些患者有幫助，藥物

Got it. Yes, thank you for the comment. And then just one more question from me is the German label or this label seems pretty favorable. And then you say, well, you will launch Vyjuvek in German, in the year. So how should we think about the trajectory of that compared to US? I believe in the past that you also benchmark to US launch. So do you still hold the same view here? Thank you.

知道了。是的，謝謝你的評論。我還想問一個問題，德國標籤或這個標籤看起來相當不錯。然後你說，好吧，你將在今年推出德語版的 Vyjuvek。那麼與美國相比，我們該如何看待其發展軌跡呢？我相信過去你們也以美國的發佈為基準。那麼，您仍然持有同樣的觀點嗎？謝謝。

Yes. So look Roger, Germany, we plan to launch in Q3. As I mentioned in the call, patient identification is less of an issue in Europe. They're all genetically sequenced, and it really helps because now, in terms of our growth targets, we have the same objective in every country, trying to get to like a 60% market share in two years.

是的。所以，德國，羅傑，我們計劃在第三季推出。正如我在電話中提到的，在歐洲，病患身分識別並不是什麼大問題。它們都經過基因定序，這確實有幫助，因為現在，就我們的成長目標而言，我們在每個國家都有相同的目標，力爭在兩年內達到 60% 的市佔率。

It is a really big stretch. It's a really big goal, but even getting close to it means that the launch has gone really, really well. But in terms of trajectory, I think we need a quarter or so after launch to kind of determine, but there is quite a bit of existing demand to get on drugs, both in Germany and in France.

這確實是一個很大的挑戰。這是一個非常大的目標，但即使接近目標也意味著發布會進展得非常非常順利。但就發展軌跡而言，我認為我們需要在推出後一個季度左右的時間才能確定，但無論是在德國還是法國，對毒品的需求都相當大。

Excellent. Thanks. Congrats for the quarter

出色的。謝謝。恭喜本季

Ritu Baral, TD Cowen.

Ritu Baral，TD Cowen。

Good morning guys, thanks for taking the question. On the increase in Salesforce, Krish, by how much are you increasing headcount and are these sort of boots on the ground reps or are they sort of back office helping with reimbursement and patient support and how much of this new initiative essentially for increasing the Salesforce is related to rising DDEB? How much is potential increasing competition coming up in the next 12 months?

大家早安，謝謝你們回答這個問題。關於 Salesforce 的成長，Krish，您計劃增加多少員工人數？這些是實地代表嗎？還是後台辦公室幫忙報銷和病患支援？這項旨在增加 Salesforce 的新措施與 DDEB 的成長有多少關係？未來 12 個月內競爭可能會加劇多少？

Jen, you want to take the first step?

Jen，你想踏出第一步嗎？

Yes, I'll take us out of this. So we started our efforts here in Q1 based on, as mentioned, as we get deeper in the community, it takes more educational efforts of both the HCPs as well as to work to engage the patients into the HCP offices.

是的，我會帶我們離開這裡。因此，我們在第一季就開始了我們的努力，正如前面提到的，隨著我們在社區中的深入，我們需要對 HCP 進行更多的教育，並努力讓患者參與 HCP 辦公室。

So as a result of that, we did enhance our field force efforts starting in Q1. We're still monitoring the impact of that and then evaluating how we want to proceed from there. But it's really about our goal is to achieve and strive to reach every DEB patient. And in doing that, it's taking more time so we're adding efforts to support that.

因此，我們從第一季開始確實加強了現場力量的投入。我們仍在監測其影響，然後評估我們希望如何繼續進行。但我們的目標其實是努力實現並惠及每一位 DEB 患者。而這樣做需要花費更多時間，因此我們正在加強來支持這一點。

I just want to -- it's not a function of a competitive situation at all. It's more in terms of trying to get a certain level of demand in a particular quarter as the time to get a PSF is taking longer as we go further into the community.

我只是想——這根本不是競爭情勢的結果。這更多的是為了在特定季度獲得一定程度的需求，因為隨著我們進一步深入社區，獲得 PSF 的時間會變得更長。

And how much of this, Krish, is related to DDEB? In our last tracking survey, we were seeing rapid uptake in DDEB patients and intent to treat by clinicians in more DDEB. So we're just wondering how that impacts numbers, return to treatment, whether these patients resolve their lesions faster, et cetera.

那麼，Krish，這與 DDEB 有多少關係？在我們上次的追蹤調查中，我們看到 DDEB 患者數量迅速增加，臨床醫生有意治療更多的 DDEB。所以我們只是想知道這對數字、恢復治療有何影響，這些患者是否能更快解決病變等等。

Yes, I mean, our percentage of DDEB patients is definitely on the rise. DDEB patients, because they're not severe, need a little bit more education in terms of getting Vyjuvek. We make a strong case. We have seen a lot of dominant patients, not a lot, but a percentage of dominant patients.

是的，我的意思是，我們的 DDEB 患者比例肯定在上升。由於 DDEB 患者的病情並不嚴重，因此需要對服用 Vyjuvek 進行更多的教育。我們提出了強而有力的論點。我們見過很多占主導地位的病人，不是很多，但佔了一定比例。

So just as severe as recessive, sometimes they learn to live with the disease. And so to pull them through requires education on the part of the physician, education with respect to how the disease can potentially get, there's always a chance of getting squamous cell.

因此，儘管隱性遺傳疾病很嚴重，但有時患者還是會學會與疾病共存。因此，要幫助他們度過難關，就需要醫生對他們進行教育，讓他們了解這種疾病的潛在發展方式，總是有可能患上鱗狀細胞病。

And so, yes, so you're right, Ritu. I think as we go into the community, as we start to get more dominant patients, the cycle time of getting a PSF is taking longer. And by having additional reps and having reps cover a territory that was not as big as prior will definitely help bring it forward.

是的，你是對的，Ritu。我認為，隨著我們進入社區，隨著我們開始接收更多主要患者，獲得 PSF 的週期會變得更長。透過增加銷售代表並讓銷售代表涵蓋之前沒有那麼大的領域，肯定有助於推動這一進程。

Great, thank you.

太好了，謝謝。

Gavin Clark-Gartner, Evercore ISI.

Gavin Clark-Gartner，Evercore ISI。

Hey guys, thanks for taking the questions. On the compliance side, so the figure you report is still reported as since launch. I was curious how it's tracking on more of a quarterly or a run rate type of basis?

嘿夥計們，感謝你們回答問題。在合規方面，您報告的數字仍是自發布以來報告的。我很好奇它是怎樣以季度或運行率類型為基礎進行追蹤的？

Look, Gavin, I'll answer. Look, we've been consistent in mentioning compliance since launch. It has served well over the last 12, 15 months or so, but definitely will paint a slightly different picture than what happens in a quarterly basis. And I'll turn it over to Jen to describe the quarterly behavior. The only point I'll make, the reason we're not putting up another stat in terms of your answer, as I mentioned in the call, it's tough to predict pausing, right?

聽著，加文，我會回答的。你看，自推出以來，我們一直在提到合規性。在過去的 12 到 15 個月左右的時間裡，它發揮了良好的作用，但肯定會與季度情況略有不同。我將把時間交給 Jen 來描述季度行為。我唯一要說的一點是，我們沒有在您的回答中提出另一個統計數據，正如我在電話中提到的那樣，很難預測暫停，對嗎？

Let's say it was a particular number and they all come back over the next quarter. And all of a sudden you're in this wavy pattern again. So we're being cautious about trying to put a number out that we don't have enough history on, but with that, we'll send it over.

假設這是一個特定的數字，它們都會在下個季度回來。突然間你又回到了這種波浪形的模式。因此，我們對於嘗試提供我們沒有足夠歷史記錄的數字持謹慎態度，但只要有這個數字，我們就會將其發送過去。

I think one thing that we can be solid on is that patients are compliant to weekly therapy. That is not an issue. The convenience around at home dosing allows that weekly application with no issue at all. So as prescribed weekly to open wound, we're 100% confident on and patients are not concerned about that at all.

我認為我們可以確信的一件事是患者遵守每週的治療。那不是問題。由於在家中給藥十分方便，因此每週使用一次都不會有任何問題。因此，對於每週對開放性傷口進行治療，我們 100% 有信心，患者根本不擔心這一點。

And I mentioned in my speech around persistence, that's the combination that we're trying to evaluate as Krish mentioned. So on a quarterly basis, patients are extremely compliant in that high range because they're taking it week-to-week. It's the persistence when we look at like a one year mark or an 18 month mark that we're being cautious on as we try to understand the wounding behaviors and how we segment patients potentially based on their disease severity.

我在演講中提到了堅持，正如克里希 (Krish) 所提到的，這就是我們試圖評估的組合。因此，按季度計算，患者的依從性非常高，因為他們每週都在服用藥物。當我們觀察一年或 18 個月的標記時，我們會保持謹慎，因為我們試圖了解傷害行為以及如何根據病情嚴重程度對患者進行細分。

Got it. That makes sense. And just to follow-up on the same topic, I believe the way you do the calculation, if a patient has been completely off drug for a certain amount of time, I think they get excluded from the denominator of the calculation. Is that right? And what's that period of time again?

知道了。這很有道理。為了跟進同一主題，我相信您進行計算的方式，如果患者已經完全停藥一段時間，我認為他們會被排除在計算的分母之外。是嗎？那段時間又是什麼呢？

No, actually it's while they're on therapy. So if they do come back, then we look at that start date, end date from the entire time that they had experience with Vyjuvek. So they would always be in the denominator. We don't take them out. So if they come back on, like I said, their compliance percentage would go down. It's when they stay off that it just maintains where they were at while they were on therapy.

不，實際上是在他們接受治療的時候。因此，如果他們確實回來，那麼我們會查看他們使用 Vyjuvek 的整個時間的開始日期和結束日期。所以它們總是在分母中。我們不把它們帶出去。所以如果他們回來，就像我說的，他們的遵守率就會下降。當他們停止治療時，它只是維持他們在接受治療時的狀態。

Okay. So in other words, if someone comes off drug, they don't get counted until they come back on?

好的。換句話說，如果有人戒毒了，那麼直到他們再次吸毒之前，都不會被統計在內？

Well, they stay in the calculation of where they were at while they were on therapy.

嗯，他們繼續計算他們接受治療時的情況。

Okay. Got it. Thank you.

好的。知道了。謝謝。

Sami Corwin, William Blair.

薩米·科溫、威廉·布萊爾。

Hey guys, congrats on the progress and thanks for taking my question. I was wondering if you could talk a bit more about the EU launch and how we should think about the cadence a patient starts and the first dose needs to be administered in an office by a physician. And then kind of going back to the patient start-stops. I mean, any stats you could really provide us on patients that have stopped therapy and not restarted? Thank you.

嘿，大家好，祝賀你們取得的進展，感謝你們回答我的問題。我想知道您是否可以再多談談歐盟的啟動情況，以及我們應該如何考慮患者開始接種疫苗的節奏，以及第一劑疫苗需要由醫生在辦公室注射。然後回到病人的開始和停止。我的意思是，您能否向我們提供關於已停止治療且未重新開始治療的患者的任何統計數據？謝謝。

With respect to the EU launch, Sami, I think if there were to be a gaining factor which we are proactively addressing, it's the time it takes for the first appointment with the physician and how many can a center or a doctor accommodate in the early stages of launch.

關於在歐盟的啟動，薩米，我認為如果有一個我們正在積極解決的獲取因素，那就是與醫生的第一次預約所需的時間，以及在啟動初期一個中心或一位醫生可以容納多少人。

But if we can figure that part out, once they have actually had met with the physician, there's an opportunity for the patient to quickly transfer it into a home dosing situation where they can actually have care given administration or in some cases, self-administration.

但是如果我們能夠解決這個問題，一旦他們真正與醫生會面，患者就有機會快速將其轉移到家庭用藥情況，他們實際上可以進行護理給藥，或者在某些情況下進行自我給藥。

So -- and the rate of which, I mean, how quickly can you get an appointment? It varies by country. But we have anticipated this issue over the last six months or so. Laurent, who's the General Manager of Europe is working pretty aggressively to facilitate this.

那麼——我的意思是，您多快可以預約？它因國家而異。但我們在過去六個月左右的時間裡已經預見了這個問題。歐洲總經理 Laurent 正在積極努力地推動這項進程。

We'll know more after the first one or two months of launch how quickly this is happening and provide color. But we feel good in the sense that, I mean, this is probably the best question with respect to launch and we talked through it and are taking steps towards mitigating that.

在發布後的一兩個月內，我們將更清楚地了解這一進程的進展情況，並提供詳細資訊。但我們感覺很好，因為這可能是關於發布的最佳問題，我們已經討論過這個問題，並且正在採取措施緩解這個問題。

I can add, our MSOs have already reached out to the centers. They've educated the physicians. Everybody's pretty excited, because keep in mind there was no corrective therapy for any of these patients. So I think the most of the physicians that get educated about the drug, now that it's approved, they see the label. So obviously now, I mean, hopefully they will prioritize getting these patients in.

我可以補充一點，我們的 MSO 已經聯繫了這些中心。他們已經對醫生進行了教育。每個人都非常興奮，因為請記住這些患者都沒有接受過矯正治療。因此我認為，大多數了解該藥物的醫生都會看到該藥物的標籤，因為該藥物現在已獲得批准。所以現在顯然，我的意思是希望他們會優先接收這些病人。

And on your second question, Sami, on starts and stops. Look, there are a very small percentage of patients who do not come back on drug. And most of the time, the rationale is they are undergoing a complication that's more severe than the nature of DEB itself, which is a skin manifestation.

關於你的第二個問題，薩米，關於開始和停止。你看，只有極少數的病人不再服用藥物。大多數情況下，原因是他們正在經歷比 DEB 本身（一種皮膚表現）更嚴重的併發症。

Squamous cell carcinoma, mortality, and in terms of coming back, we, outside of that factors, I don't want to call them the beyond, that had nothing to do with the safety of the drug or the efficacy of the drug or the convenience, patients come back on drugs.

鱗狀細胞癌、死亡率以及復發率，除了這些因素之外，我不想稱它們為超越，這些與藥物的安全性、藥物的功效或便利性無關，患者會復發。

Some come back in 30, some come back in 60, some come in 90, some 120 plus. It all depends on, it's highly individual, depends on where the wound is, if they're recessive, if they're dominant, but we honestly have had no concern at all with respect to them coming back on drug.

有的 30 分鐘後回來，有的 60 分鐘後回來，有的 90 分鐘後回來，有的 120 多分鐘後回來。這完全取決於個人情況，取決於傷口的位置，是隱性遺傳還是顯性遺傳，但說實話，我們根本不擔心他們會再次吸毒。

And we actually like that pattern because that's the tail on the top that we believe will continue for a very long time. But Jen and her team, they do a great job of managing the patient experience while on drug and it's really served us well.

我們實際上喜歡這種模式，因為我們相信這種頂部尾部將會持續很長時間。但是 Jen 和她的團隊在管理患者用藥體驗方面做得非常出色，這確實為我們提供了良好的服務。

Got it. I appreciate the color.

知道了。我很欣賞這個顏色。

Andrea Newkirk, Goldman Sachs.

高盛的安德里亞紐柯克 (Andrea Newkirk)。

Good morning, thank you for taking the question. Krish, in the context of the approval of a competitor product last week, just curious based off of your market research, how you're thinking about Vyjuvek utilization on the forward and how those two products can coexist?

早上好，感謝您回答這個問題。Krish，在上週批准競爭對手產品的背景下，根據您的市場調查，我很好奇，您如何看待 Vyjuvek 在未來的應用，以及這兩種產品如何共存？

And then Suma, just quickly, if you could speak a little bit more about what we should be looking for at ASCO, how many more patients or extent of follow-up will be included? Thank you.

然後，Suma，您能否簡單談談我們在 ASCO 上應該尋找什麼，將包括多少患者或多少範圍的追蹤？謝謝。

Look, I'll start on the recent approval question. Look, when Krystal was founded in 2016, it was founded on the principle that Suma felt that an autologous way of treating DEB is not sustainable. That was the premise of Krystal founding. And I'll turn it over. There are issues on this. I mean, there's so many differences on safety side, efficacy side, convenience side.

瞧，我將從最近的批准問題開始。你看，當 Krystal 於 2016 年成立時，它建立在這樣的原則上：Suma 認為自體治療 DEB 的方式是不可持續的。這就是 Krystal 創立的前提。我會把它翻過來。這方面存在一些問題。我的意思是，在安全性、功效和便利性方面存在著許多差異。

Suma, if you can quickly (multiple speakers)

Suma，如果你能快點（多位發言者）

I mean, as you said, we don't consider the product competition at the moment because of the differences. Obviously, it's indicated for just our DEB and clearly there are safety differences, as you can see on oncogenesis, anaphylaxis and also the graft is not sterile.

我的意思是，正如你所說，由於存在差異，我們目前不考慮產品競爭。顯然，它僅適用於我們的 DEB，並且顯然存在安全性差異，正如您所看到的致癌性、過敏性休克以及移植物不是無菌的。

So that itself can cause infection in these patients. So there are a lot of safety issues from an efficacy perspective. There is a controlled study, not blinded, and it's done at just majority of the patients came out of Stanford. So it's an unblinded study, unlike us. We are randomized, blinded, multi-site study.

這本身就會導致這些患者感染。因此，從功效角度來看，存在著許多安全問題。有一項對照研究，不是盲法研究，而且該研究針對的是來自史丹佛大學的大多數患者。所以這是一項非盲研究，與我們不同。我們進行的是隨機、盲法、多地點研究。

And if you look at efficacy, the efficacy is, I mean, pretty robust for us, 100% closure at six months. There's 50% at six months. I mean, though they say there's improvement in pain, adverse event if you have pain-induced during surgery, the patient has to be biopsied.

如果你看一下療效，我的意思是，對我們來說，療效是相當強勁的，六個月內 100% 就能痊癒。六個月就有50%。我的意思是，儘管他們說疼痛有所改善，但如果手術過程中出現疼痛，患者就必須接受活檢。

The biopsies can fail, they have to repeat, administer. And if you look at their dose, it's just 40 centimeters spare of graft. Often these wounds are not exactly shape of a graft. So they have to use this in their label. They have to debride these wounds, open the wounds to administer the duct. So there is additional burden to these patients.

活檢可能會失敗，他們必須重複進行。如果你看他們的劑量，你會發現移植的長度只剩下 40 公分。這些傷口通常並不完全是移植的形狀。所以他們必須在標籤中使用它。他們必須清創這些傷口，打開傷口來放置導管。因此這些患者承受著額外的負擔。

So once, I mean, there's apples and oranges, whereas us, its home administered, easy to compare label-to-label, we don't consider this as a competition. So now, I mean, our second question was an ASCO. We are absolutely excited about our ASCO poster. It's going to be a poster talk. Many of the physicians are, I mean, it's novel, because we can administer cytokines directly to the lungs in a safe, effective manner. We have already demonstrated that. I mean, safety is one of the biggest concerns. We have overcome that burden.

所以，我的意思是，有蘋果和橘子，而我們，它是家庭管理的，很容易比較標籤與標籤，我們不認為這是一場比賽。所以現在，我的意思是，我們的第二個問題是 ASCO。我們對我們的 ASCO 海報感到非常興奮。這將是一場海報演講。許多醫生都認為這是新穎的，因為我們可以以安全有效的方式將細胞激素直接注入肺部。我們已經證明了這一點。我的意思是，安全是最大的擔憂之一。我們已經克服了這個負擔。

And in December, we presented the data in 11 patients in NMCCL. And at that time, we had data cut of November, now we have additional, I mean, three or four months data on the same patients that we presented. So you will see revised numbers on advocacy, safety, as well as you will see images of the scans, where you saw shrinking of the tumor. So we're very, very excited about the poster.

12 月，我們公佈了 NMCCL 11 名患者的數據。當時，我們有 11 月的數據，現在我們有關於我們所呈現的相同患者的另外三到四個月的數據。因此，您將看到關於宣傳、安全的修訂數字，同時您還將看到掃描影像，其中您將看到腫瘤縮小。所以我們對這張海報感到非常興奮。

Debjit Chattopadhyay, Guggenheim Securities.

古根漢證券的 Debjit Chattopadhyay。

Hey, good morning, and thank you for taking the questions. I have a couple. So, number one, could you elaborate on the subpoena with respect to the genetic testing? And does that impact prior revenue recognition or future implications?

嘿，早上好，感謝您回答問題。我有一對。那麼，第一，您能詳細說明一下有關基因檢測的傳票嗎？這是否會影響先前的收入確認或未來的影響？

Hey, on that, we're fully cooperating with the DOJ, and we have no further comment on that at the moment.

嘿，關於這一點，我們正在全力配合司法部，目前我們對此沒有進一步的評論。

And the second question, just to clarify, the 83% compliance rate that is being reported, that includes the patients who are, let's say one week on, one week off, right? I mean, your 83% assumes that there is going to be partial compliance, at least in the patients who are on therapy for the longest?

第二個問題，需要澄清的是，報告的 83% 的遵從率，包括了治療一週、休息一週的患者，對嗎？我的意思是，83% 的人認為至少在接受治療時間最長的患者中，治療將會部分順利完成？

Correct.

正確的。

That's right. It includes any missed dose, like while they're on therapy. So that's how it gets adjusted lower. If somebody misses and then comes back, it would calculate as missed doses.

這是正確的。其中包括任何錯過的劑量，例如在接受治療期間。這就是它如何被調低的。如果有人錯過然後又回來，則會被視為錯過劑量。

And one last follow-up. In the patients who are still being treated or managed at the community centers who you still don't have on therapy, did we assume that off the bat, these are milder patients and compliance to start off is going to be on the lower end of what you currently have versus the more severe or DEB patients? Thank you.

最後再跟進一下。對於仍在社區中心接受治療或管理且尚未接受治療的患者，我們是否從一開始就假設這些是病情較輕的患者，並且與病情較重或 DEB 患者相比，其依從性一開始就會處於您目前水平的較低水平？謝謝。

Look, early on, irrespective of whether you're RDEB or DDEB in the community or a COE, your compliance is pretty good. Where the line DBA is the wound completely -- one of the reasons for patients stopping on drugs, the biggest reason is all wounds are healed.

你看，早期，無論你是社區中的 RDEB 還是 DDEB，還是 COE，你的依從性都相當不錯。DBA 所在的線是傷口完全癒合——患者停止用藥的原因之一，最大的原因是所有傷口都癒合了。

And all wounds are healed, happens faster in a dominant patient, much faster than in a recessive patient. And then in terms of comeback times, dominant patients take a bit longer on the repeat than the RDEB patients who are much more sensitive, much more focused on their wounds.

所有傷口都會癒合，顯性患者癒合得更快，比隱性患者快得多。就恢復時間而言，顯性患者需要比 RDEB 患者更長的時間，因為 RDEB 患者更敏感，並且更關注自己的傷口。

But outside of that, besides one being -- and then there's a spectrum, right? There's a severe, there's a moderate, there's a mild, but the nature of getting on being so early on, the compliance is no different between recessive and dominant for an extended period.

但除此之外，除了一個存在之外──還有一個範圍，對嗎？有嚴重的，有中度的，有輕微的，但由於發病時間太早，長期來看，隱性和顯性之間的依從性並沒有什麼不同。

Yigal Nochomovitz, Citigroup.

花旗集團的 Yigal Nochomovitz。

Hi, Krish and team. I had a question on the Japan market with the upcoming approval there. Can you just discuss how the Japan market will contribute to the global revenue picture for Vyjuvek ? And do you have any numbers in terms of the identified patients there in Japan based on genetic testing, as well as the overall prevalence compared to Europe and the United States? Thanks.

嗨，Krish 和他的團隊。我對即將獲得批准的日本市場有一個疑問。您能否討論一下日本市場將如何為 Vyjuvek 的全球收入做出貢獻？？您能否提供日本透過基因檢測確診的患者數量，以及與歐洲和美國相比的整體盛行率數據？謝謝。

Yes, you should look the overall prevalence, and I'm giving a number that could be off 10%, is about 500, north of 200, 225, some of that range are fully identified. We just had the inspection, which went pretty well. So it's a pretty attractive market. And pricing tends to be -- no, I wouldn't say comparable to the US, but somewhere between US and Europe price is where Japan price ends, if we do a good job of making a strong value proposition.

是的，你應該看看整體盛行率，我給出的數字可能有 10% 的偏差，大約是 500，在 200、225 以北，其中一些已經完全確定。我們剛剛進行了檢查，一切進展順利。所以這是一個相當有吸引力的市場。而且定價往往是——不，我不會說與美國相當，但如果我們能很好地提出強有力的價值主張，那麼美國和歐洲價格之間的某個地方就是日本價格的終點。

And if you look at some of the other companies in the rare disease market, Japan's been very attractive compared to some European countries. And so we look forward to launching in Japan, hopefully by the end of this year, if not early next year.

如果你看看罕見疾病市場中的其他一些公司，你會發現與一些歐洲國家相比，日本非常有吸引力。因此，我們期待在日本推出該產品，希望是在今年年底，如果不是明年年初的話。

And you mentioned you just had the inspection, what was the outcome of that?

您提到剛剛進行了檢查，結果如何？

I mean, this was, we had both the clinical and the CMC inspection because we did study, we did have Japanese particular study, and obviously the manufacturing facility at Encoris was inspected (inaudible) for the drug.

我的意思是，我們進行了臨床和 CMC 檢查，因為我們確實進行了研究，我們確實進行了日本的特定研究，顯然 Encoris 的製造工廠也接受了該藥物的檢查（聽不清楚）。

Yeah, look without getting because we don't have (inaudible).I mean, I can broadly say inspection went well there were no--

是的，看而不得到，因為我們沒有（聽不清楚）。我的意思是，我可以大致說檢查進行得很順利，沒有——

No Binding.

無約束力。

Okay, thank you.

好的，謝謝。

Thank you. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.

謝謝。今天的電話會議到此結束。現在您可以斷開電話線並享受美好的一天。感謝您的參與。