Abeona Therapeutics Inc (ABEO) 2026 Q2 法說會逐字稿

Good morning, everyone, and welcome to Abeona Therapeutics 2Q 2026 conference call. (Operator Instructions) Please note this conference is being recorded.

各位早安，歡迎參加 Abeona Therapeutics 2026 年第二季（2Q 2026）電話法說會。(接線員指示) 請注意，本次會議將被錄音。

I will now turn the conference over to your host, Gregory Gin, Vice President, Investor Relations and Corporate Development. Greg, the floor is yours.

現在我將把會議交給本次主持人——投資人關係與企業發展副總裁 Gregory Gin。Greg，交給你了。

Thank you, Jenny. Good morning, and thank you, everyone, for joining us on our second quarter 2026 results conference call. During this call, we will refer to the press release issued this morning announcing the financial results. It's available on our corporate website at www.abeonatherapeutics.com.

謝謝你，Jenny。各位早安，也感謝大家參加我們 2026 年第二季財報電話會議。在本次會議中，我們將引用今天早上發布、公告財務結果的新聞稿。新聞稿可於我們公司網站 www.abeonatherapeutics.com 取得。

Joining me on today's call are Dr. Vish Seshadri, Chief Executive Officer; Dr. Madhav Vasanthavada, Chief Commercial Officer; Joe Vazzano, Chief Financial Officer; and Dr. Brian Kevany, Chief Technical Officer. We anticipate making projections and forward-looking statements during today's call, which are made pursuant to the safe harbor provisions of the federal securities laws.

今天與我一同出席的有：執行長 Vish Seshadri 醫師；商務長 Madhav Vasanthavada 醫師；財務長 Joe Vazzano；以及技術長 Brian Kevany 醫師。我們預期在今天的電話會議中將提出預測與前瞻性陳述，該等陳述係依據聯邦證券法的「安全港」條款作出。

These forward-looking statements are based on current expectations and are subject to change. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those outlined in our Form 10-K and periodic reports filed with the Securities and Exchange Commission. These documents are available on our website at www.abeonatherapeutics.com.

這些前瞻性陳述係基於目前的預期，且可能變動。由於各種因素，實際結果可能與前瞻性陳述中明示或暗示者存在重大差異，包括但不限於我們在 Form 10-K 與向美國證券交易委員會（SEC）提交的定期報告中所列之因素。上述文件可於我們網站 www.abeonatherapeutics.com 查閱。

And with that, I will now turn the call over to Vish Seshadri to please start. Vish?

接下來，我將把電話交給 Vish Seshadri 開場。Vish？

Thank you, Greg, and good morning, everyone. I'll begin today with an overview of our commercial progress before turning the call over to Madhav for operational details. Our commercial experience to date reinforces our confidence in ZEVASKYN's substantial commercial opportunity.

謝謝你，Greg，各位早安。我今天將先概述我們的商業化進展，之後再把電話交給 Madhav 說明營運細節。截至目前的商業化經驗，進一步強化我們對 ZEVASKYN 具備龐大商業機會的信心。

During the second quarter, we advanced our rollout by expanding our qualified treatment center network and progressing more patients through the treatment pathway. With the recent addition of Cincinnati Children's, which is one of the largest epidermolysis bullosa treatment centers in the country, we now have seven activated QTCs nationwide. Importantly, CHOP and UTMB are biopsying patients and CHOP has completed its first treatment.

在第二季期間，我們透過擴大合格治療中心（QTC）網絡並推動更多病患完成治療流程，持續推進上市推廣。隨著近期新增 Cincinnati Children's（辛辛那提兒童醫院）——該院為全美最大的表皮分離性水皰症（EB）治療中心之一——我們目前在全美已啟動七家 QTC。重要的是，CHOP 與 UTMB 已在為病患進行活檢取樣，且 CHOP 已完成其首例治療。

We have treated 12 patients since launch, including five in the second quarter of 2026 and three additional patients in the third quarter to date. As Madhav will discuss further, a couple of these treatments did not generate revenue. As our commercial footprint expands, we're refining how we report progress to the investment community.

自上市以來我們已治療 12 位病患，其中 2026 年第二季治療 5 位，第三季迄今另治療 3 位。如 Madhav 稍後將進一步說明，其中有幾例治療未產生營收。隨著我們的商業版圖擴大，我們也在精進向投資社群報告進展的方式。

Over the past quarter, we have seen that leading indicators such as scheduled biopsies or biopsies in manufacturing are subject to external variables outside our control and have limited utility in predicting revenue-generating treatments. Later on the call, Joe will outline the specific reporting updates we're making to eliminate this uncertainty and to align with standard practices of commercial stage companies.

過去一季我們觀察到，諸如已排定活檢或活檢樣本已進入製造等領先指標，會受到我們無法控制的外部變數影響，因此對於預測可產生營收的治療，其效用有限。稍後 Joe 將說明我們將進行的具體揭露更新，以消除這些不確定性，並與商業化階段公司的標準作法一致。

With that, I'll turn the call over to Madhav Vasanthavada, our Chief Commercial Officer, to detail our commercial execution and network expansion. Madhav?

接下來，我將把電話交給我們的商務長 Madhav Vasanthavada，說明我們的商業執行與網絡擴張。Madhav？

Thank you, Vish, and good morning, everyone. We are making progress in executing the launch with clear priorities, advancing identified patients through the treatment journey, strategically expanding the QTC footprint by onboarding leading EB centers and raising ZEVASKYN awareness across the EB community.

謝謝你，Vish，各位早安。我們正以明確的優先事項推進上市執行：推動已辨識病患完成治療旅程、策略性擴大 QTC 版圖以導入領先的 EB 中心，並在 EB 社群中提升 ZEVASKYN 的認知度。

Let me start with EB community engagement since we just attended back-to-back meetings, the Debra Care Conference, which is a flagship meeting for EB patients hosted by Debra of America, a patient advocacy group, and the Society of Pediatric Dermatology, SPD, Annual Meeting, where we interacted with dozens of highly engaged patients, caregivers and physicians.

我先從 EB 社群互動談起，因為我們剛連續參加兩場會議：Debra Care Conference（由病患倡議團體 Debra of America 主辦、為 EB 病患的重要旗艦會議），以及小兒皮膚科學會（Society of Pediatric Dermatology，SPD）年會；在這些活動中，我們與數十位高度投入的病患、照護者與醫師互動。

Patient ambassadors from our Strong Together Network which is a group of patients who received ZEVASKYN in clinical trials, engaged with families and physicians throughout these events, fostering meaningful dialogue, sharing the impact ZEVASKYN has had on their lives and helping connect patients and caregivers with ZEVASKYN resources and support.

我們「Strong Together Network」的病患大使——這是一群在臨床試驗中接受過 ZEVASKYN 的病患——在活動期間與家庭與醫師持續交流，促成有意義的對話，分享 ZEVASKYN 對其生活帶來的影響，並協助病患與照護者連結至 ZEVASKYN 的資源與支持。

Following these interactions and the many that we have been having in the recent months, we are energized by the opportunity and the fundamental role ZEVASKYN can play in healing RDEB wounds today and for the years to come.

在這些互動以及我們近幾個月來的多次交流之後，我們對於這項機會感到振奮，也更堅信 ZEVASKYN 能在當下以及未來多年，在癒合 RDEB 傷口方面扮演關鍵角色。

Based on our interactions with patients and caregivers, we continue to believe that the distinct value of ZEVASKYN is deeply resonating with the RDEB community. We see clinical conviction building across our QTC network and the community practices of other RDEB physicians. While we are thrilled with the patient community's interest in ZEVASKYN, our recent experience has revealed bottlenecks that we are working through in the journey from patient identification to ZEVASKYN treatment.

根據我們與病患及照護者的互動，我們仍相信 ZEVASKYN 的獨特價值正深刻引起 RDEB 社群共鳴。我們看到在 QTC 網絡以及其他 RDEB 醫師的社區診所中，臨床信心正在建立。雖然我們對病患社群對 ZEVASKYN 的興趣感到非常振奮，但近期經驗也揭示了從病患辨識到接受 ZEVASKYN 治療之旅程中存在的瓶頸，而我們正努力加以克服。

Because ZEVASKYN is the first surgically applied autologous cell therapy in dermatology and is operationally very different from traditional topical therapies, QTCs have a steep learning curve to client. As a result, the time from patient identification to patient treatment can vary considerably site to site and be influenced by a broad range of factors that are beyond the control of individual stakeholders.

由於 ZEVASKYN 是皮膚科領域首個以手術方式施作的自體細胞治療，且在作業上與傳統外用療法截然不同，QTC 需要面對陡峭的學習曲線。因此，從病患辨識到實際治療的時間，會因各中心而有顯著差異，並可能受到多種超出個別利害關係人可控範圍的因素影響。

Executing the launch has provided us with several real-world learnings, of which I'd like to highlight three important ones. First, administering ZEVASKYN, which has an 84-hour shelf life, requires a QTC to execute seamless real-time coordination across multiple stakeholders.

在執行上市推廣的過程中，我們獲得了若干真實世界的學習，我想重點分享其中三項重要發現。第一，施作 ZEVASKYN（保存期限為 84 小時）需要 QTC 在多方利害關係人之間進行無縫、即時的協調。

Well before requesting a biopsy slot, dermatologists, surgical specialists, anesthesiologists and hospital staff must lock in precise dates for biopsy appointments for operating room reservations and for surgeon and medical teams. These unique operational dynamics require even greater planning, particularly when patient and physician availability can be limited with holidays and back-to-school planning, and we have seen this lead to scheduling disruptions for biopsy and treatment dates.

在提出活檢時段需求之前，皮膚科醫師、外科專科醫師、麻醉科醫師與院方人員必須先敲定精確日期，用於活檢門診安排、手術室預約，以及外科醫師與醫療團隊的排班。這些獨特的作業動態需要更周延的規劃，尤其在假期與開學規劃期間，病患與醫師的可用時間可能受限；我們也看到這會導致活檢與治療日期的排程中斷。

Second learning, on the clinical side, we have observed that the health of harder patients can sometimes change unexpectedly, which can lead to unavoidable biopsy delays or cancellations. In the second quarter, patient health deterioration resulted in two last-minute cancellations of scheduled biopsies. Because of the amount of coordination required at the QTC with payer and patient schedules well before booking the treatment slot, a last-minute cancellation means that the slot cannot be filled by another patient.

第二項學習是在臨床端：我們觀察到病情較嚴重的病患，其健康狀況有時會出現不可預期的變化，進而導致無可避免的活檢延後或取消。在第二季，病患健康惡化造成兩次已排定活檢的臨時取消。由於在預訂治療時段之前，QTC 需提前與付款方及病患時程進行大量協調，臨時取消意味著該時段無法由其他病患遞補。

Lastly, on the supply side, as our patient sample size has continued to grow, we have learned that manufacturing yields can be influenced by variability in the incoming biopsy material. These factors resulted in one low-yield batch in Q2 and one out of specification batch in Q3, for which no revenue was recognized. Despite these challenges, we are gratified that both patients received treatment.

最後，在供應端，隨著我們的病患樣本數持續增加，我們了解到製造產率可能會受到進廠活檢材料差異性的影響。這些因素在第二季導致一批低產率批次，在第三季導致一批不符合規格的批次，兩者皆未認列營收。儘管面臨這些挑戰，我們仍欣慰兩位病患都已接受治療。

While the launch has highlighted these complexities, they have provided valuable operational and commercial learnings that continue to strengthen execution by both Abeona and its QTC partners. Importantly, despite these complexities, we have maintained a steady quarterly growth and 12 patients have now been treated with ZEVASKYN since launch. As we apply these launch learnings, our focus remains on ensuring more patients enter the top of the funnel to help offset patient attrition that can occur for reasons beyond our control.

雖然此次上市凸顯了這些複雜性，但也帶來了寶貴的營運與商業層面的學習，持續強化 Abeona 與其 QTC 合作夥伴的執行力。重要的是，儘管存在這些複雜性，我們仍維持穩健的季度成長，自上市以來目前已有 12 名患者接受 ZEVASKYN 治療。在我們運用這些上市經驗之際，我們的重點仍是確保有更多患者進入漏斗頂端，以協助抵銷因我們無法控制的原因而可能發生的患者流失。

A key component of that strategy is continued expansion of our qualified treatment center network, continued engagement with the EB community and improving patient access. Towards that end, during the second quarter, we activated two leading institutions, New York-Presbyterian, Columbia University Irving Medical Center and Children's Hospital of Philadelphia, CHOP.

該策略的一個關鍵組成部分，是持續擴大我們的合格治療中心（QTC）網絡、持續與 EB 社群互動並改善患者可近性。為此，在第二季期間，我們啟用兩家領先機構：紐約長老會醫院（New York-Presbyterian）、哥倫比亞大學歐文醫學中心（Columbia University Irving Medical Center）以及費城兒童醫院（Children's Hospital of Philadelphia, CHOP）。

More recently, Cincinnati Children's Hospital, one of the largest ED centers in the US has come on board. Activating treatment sites has taken significant time and commitment from QTCs and Abeona teams, and I want to thank everyone involved who helped achieve our stated goal of activating seven QTCs by the end of this year.

更近期，辛辛那提兒童醫院（Cincinnati Children's Hospital）——美國最大的 ED 中心之一——也已加入。啟用治療據點需要 QTC 與 Abeona 團隊投入大量時間與承諾，我要感謝所有參與並協助我們達成今年年底前啟用 7 家 QTC 既定目標的夥伴。

With our expanded QTC network, about 40% of our addressable market now has in-state access to a QTC based on claims analysis. In addition, our QTCs also provide specialized care for a sizable portion of patients traveling from out of state, which enables even broader patient access.

隨著我們擴大的 QTC 網絡，根據理賠分析，目前約 40% 的可觸及市場已可在州內取得 QTC 服務。此外，我們的 QTC 也為相當比例的外州就醫患者提供專科照護，進一步擴大患者可近性。

That said, we are getting requests from additional EB centers to onboard ZEVASKYN, and we plan to work with those centers to further our expansion of the QTC network. While site activation is a critical milestone, it is only a first step that allows a QTC to initiate ZEVASKYN treatment process, including consultation, patient workup and payer engagement.

話雖如此，我們也收到更多 EB 中心希望導入 ZEVASKYN 的需求，我們計畫與這些中心合作，進一步擴張 QTC 網絡。雖然據點啟用是一個關鍵里程碑，但它只是第一步，使 QTC 得以啟動 ZEVASKYN 的治療流程，包括諮詢、患者評估與保險支付方（payer）溝通。

Our commercial and medical teams continue to communicate regularly with each activated center as they build treatment readiness and administrative planning, including pharmacy and therapeutics committee review, prior authorization and payer agreement processes and planning for surgery and logistics.

我們的商業與醫療團隊持續與每一家已啟用中心定期溝通，協助其建立治療就緒度與行政規劃，包括藥事與治療委員會審查、事前授權、與支付方協議流程，以及手術與物流規劃。

As an example of exceptional operational efficiency, CHOP completed its first ZEVASKYN treatment in July, shortly after its activation in May. UTMB recently completed its first patient biopsy, representing another important step towards future treatments and overall, reflecting growth in the number of QTCs that are treating patients.

以卓越的營運效率為例，CHOP 在 5 月啟用後不久，於 7 月完成其首例 ZEVASKYN 治療。UTMB 近期完成首位患者的活檢，代表邁向未來治療的另一項重要步驟；整體而言，也反映出正在治療患者的 QTC 數量持續增加。

Next, as we think about the long-term adoption curve for ZEVASKYN, we know that physician confidence and learning builds over time. Our QTC physicians rely heavily on multicenter real-world experience shared through peer-to-peer dialogue before transitioning a new therapy like ZEVASKYN into standard practice.

接下來，當我們思考 ZEVASKYN 的長期採用曲線時，我們知道醫師的信心與學習會隨時間累積。在將 ZEVASKYN 這類新療法轉為常規實務之前，我們的 QTC 醫師高度仰賴透過同儕對話分享的多中心真實世界經驗。

As we actively facilitate best practice sharing amongst QTCs and the early treaters observe positive post-treatment outcomes and share them with their peers, we believe that this growing clinical conviction will trigger the tipping point that bridges initial experience to broad clinical adoption and routine prescribing across our entire QTC network.

隨著我們積極促進 QTC 之間的最佳實務分享，且早期治療者觀察到正向的治療後結果並與同儕分享，我們相信這股日益增強的臨床信念將觸發臨界點，銜接初期經驗與廣泛臨床採用，並在整個 QTC 網絡中形成常態處方。

Based on recent discussions with RDEB physicians, we expect that enthusiasm for ZEVASKYN will continue to build as RDEB physicians see and share even more examples of positive treatment outcomes. Equally important for adoption is ensuring economic alignment and reimbursement for our treatment centers across all payer channels. To that end, we achieved a significant milestone from CMS, granting new technology add-on payment or NTAP status for ZEVASKYN effective October 1, 2026, for fiscal year 2027.

根據近期與 RDEB 醫師的討論，我們預期隨著 RDEB 醫師看到並分享更多正向治療結果案例，對 ZEVASKYN 的熱忱將持續升溫。同樣重要的是，必須確保我們的治療中心在所有支付方通路上具備經濟一致性與可獲得報銷。為此，我們自 CMS 取得一項重大里程碑：核准 ZEVASKYN 取得新技術加成給付（new technology add-on payment, NTAP）資格，自 2026 年 10 月 1 日起生效，適用於 2027 財政年度。

NTAP is a CMS program that provides hospitals with supplemental reimbursement for eligible new high-cost and innovative therapies during inpatient stays, helping to cover the costs beyond standard DRG payments. For fiscal year 2027, CMS had received 15 new applications under the traditional pathway, and ZEVASKYN was one of only three to achieve NTAP status.

NTAP 是 CMS 的一項計畫，於住院期間為符合資格的新型高成本創新療法提供醫院補充性報銷，以協助支付超出標準 DRG 給付之外的成本。在 2027 財政年度，CMS 透過傳統途徑共收到 15 件新申請，而 ZEVASKYN 是僅有的 3 項獲得 NTAP 資格者之一。

The other 12 either did not meet the requirements or withdrew their applications or were denied. We are pleased that CMS has granted ZEVASKYN a new technology add-on payment. This is a significant recognition that comes after months of clinical -- rigorous clinical review and public commentary. And it is an external validation of the newness, cost criterion and substantial clinical improvement that ZEVASKYN offers over existing treatment options for RDEB.

其餘 12 件則因未符合要求、撤回申請或遭到否決。我們很高興 CMS 已授予 ZEVASKYN 新技術加成給付。這是一項重要的肯定，歷經數月的臨床——嚴謹的臨床審查與公開意見徵詢後取得。同時，這也是外部對 ZEVASKYN 相較於現有 RDEB 治療選項所具備的新穎性、成本標準與顯著臨床改善的驗證。

While Medicare represents about 10% of RDEB payer mix, NTAP now provides a mechanism for hospitals to seek a substantial add-on reimbursement and facilitate patient access. In closing, we remain encouraged by the demand we see and are focused on ensuring eligible patients can receive ZEVASKYN. Our approach is to achieve this by building robust access, expanding our QTC networks and further improving patient and QTC treatment experiences, which is exactly what we are doing.

雖然 Medicare 約占 RDEB 支付方組合的 10%，但 NTAP 現在提供一項機制，使醫院得以申請可觀的加成報銷並促進患者可近性。最後，我們仍對所見需求感到鼓舞，並專注於確保符合資格的患者能接受 ZEVASKYN。我們的做法是透過建立健全的可近性、擴大 QTC 網絡，並進一步改善患者與 QTC 的治療體驗來達成，而這正是我們正在做的事。

With that, I'll now pass the call to our Chief Financial Officer, Joe Vazzano, to discuss our financial results.

接下來，我將把電話會議交給我們的財務長 Joe Vazzano，請他說明我們的財務結果。

Thanks, Madhav. Let me start by reviewing the reporting changes we're making to provide maximum transparency and align with standard commercial stage practices. We will anchor future quarterly disclosures around completed operational achievements, specifically patients treated during the quarter and net revenue recognized. Consequently, going forward, we will report treatment activity solely within the designated quarter.

謝謝你，Madhav。我先從我們正在進行的報導變更談起，以提供最大透明度並與商業化階段的標準作法一致。未來我們將以已完成的營運成果作為季度揭露的核心，具體包括當季接受治療的患者數以及已認列的淨營收。因此，往後我們將僅在指定季度內報告治療活動。

Before reviewing the financial results, I would like to remind everyone that you can find additional details for the quarter ended June 30, 2026, in our most recent Form 10-Q. Starting with the statements of operations.

在檢視財務結果之前，我想提醒各位，關於截至 2026 年 6 月 30 日止季度的更多細節，可在我們最新的 Form 10-Q 中查閱。先從營運報表（statements of operations）開始。

For the quarter ended June 30, 2026, Abeona reported net ZEVASKYN revenue of $11.4 million, representing a quarter-over-quarter increase of 31% or $2.7 million compared to $8.7 million in the first quarter of 2026. While five patients were treated with ZEVASKYN during the second quarter of 2026, we recognized revenue for four treatments as one batch had cell yield that was below the thresholds for revenue recognition.

截至 2026 年 6 月 30 日止季度，Abeona 報告 ZEVASKYN 淨營收為 1,140 萬美元，較 2026 年第一季的 870 萬美元季增 31%，增加 270 萬美元。雖然 2026 年第二季共有 5 名患者接受 ZEVASKYN 治療，但我們僅就其中 4 次治療認列營收，因其中一批次的細胞產量低於營收認列門檻。

Research and development expenses were $5 million for the second quarter of 2026 compared to $9.6 million in the first quarter of 2026. R&D expenses in the first quarter of 2026 included a one-time upfront cost of $7 million for in-licensing ABO-701. Selling, general and administrative expenses were $15.8 million for the second quarter of 2026 compared to $19.5 million for the first quarter of 2026. The decrease primarily reflects fewer engineering runs and less manufacturing training costs in the second quarter of 2026.

2026 年第二季研發費用為 500 萬美元，較 2026 年第一季的 960 萬美元下降。2026 年第一季的研發費用包含一次性 700 萬美元的 ABO-701 授權引進（in-licensing）預付成本。2026 年第二季銷售、一般及行政費用為 1,580 萬美元，較 2026 年第一季的 1,950 萬美元下降。下降主要反映 2026 年第二季工程批次（engineering runs）較少，以及製造訓練成本降低。

We reported a net loss of $20.2 million or a loss of $0.35 per basic and diluted common share for the quarter ended June 30, 2026. Net loss for the first quarter of 2026 was $17.1 million or $0.30 per basic and diluted common share.

截至 2026 年 6 月 30 日止季度，我們報告淨損為 2,020 萬美元，或每股基本及稀釋普通股虧損 0.35 美元。2026 年第一季淨損為 1,710 萬美元，或每股基本及稀釋普通股虧損 0.30 美元。

As of June 30, 2026, we maintained a strong balance sheet with cash, cash equivalents and short-term investments totaling $146.8 million. Our focus remains on disciplined capital allocation as we drive toward a sustainable cash flow positive business model, which we believe is achievable by maintaining a consistent cadence of patient treatments.

截至2026年6月30日，我們維持強健的資產負債表，現金、約當現金及短期投資合計1.468億美元。在我們邁向可持續的現金流轉正商業模式之際，我們的重點仍放在嚴謹的資本配置；我們相信，只要維持穩定的病患治療節奏，這一目標是可達成的。

And with that, I will pass the call back to Vish for additional remarks before opening the call for Q&A.

接下來，我會把電話交回給Vish，在開放問答之前請他補充幾點。

Thank you, Joe. In closing, we're proud of the dedication shown by our commercial, medical, manufacturing and quality teams, and we look forward to bringing ZEVASKYN to many more families. While we continue to learn to overcome the unique launch challenges associated with the logistically complex product delivery, each learning helps us lay a strong foundation to deliver sustained long-term value to both the RDEB community and our shareholders.

謝謝你，Joe。最後，我們為商業、醫療、製造與品質團隊所展現的投入與奉獻感到自豪，也期待將ZEVASKYN帶給更多家庭。儘管我們仍在學習如何克服與物流高度複雜的產品交付相關之獨特上市挑戰，但每一次學習都在幫助我們奠定堅實基礎，為RDEB社群與股東創造可持續的長期價值。

With that, I will hand the call back to the operator to open the line for your questions.

接下來，我會把電話交回給接線員，開放各位提問。

(Operator Instructions) Maury Raycroft, Jefferies.

(接線員指示) Jefferies的Maury Raycroft。

This is [Amin] on for Maury. A couple of questions from us. First on -- you previously mentioned one patient per month per QTC is a reasonable near-term cadence. Just wanted to know when do you expect your existing QTCs, more specifically the leading ones like Lurie and Stanford to get there? And then I have a follow-up.

我是[Amin]，代替Maury發言。我們有幾個問題。首先，關於——你們先前提到，每個QTC每月一位病患是合理的近期治療節奏。想請問你們預期現有的QTC，尤其是像Lurie與Stanford這些領先中心，何時能達到這個節奏？我之後還有一個追問。

Thank you, Amin, for that question. Yes, I think Madhav is best positioned to answer this question.

謝謝你，Amin，提出這個問題。是的，我想Madhav最適合回答這個問題。

Thanks, Amin. I think, yes, we continue to hear about one patient per month from QTCs on average. And this is something that we will have once all of these centers are reaching a steady state. As we now know, earlier, Lurie and Stanford were the ones treating. Now we have biopsy from UTMB and CHOP has treated a patient.

謝謝，Amin。我想，是的，我們持續聽到QTC平均每月一位病患的說法。而當所有這些中心都達到穩態運作時，我們就會看到這樣的情況。如同我們先前所知，早期是Lurie與Stanford在進行治療。現在我們已收到UTMB的活檢樣本，且CHOP也已治療了一位病患。

So we're just waiting for other centers also to open up to be able to say when we reach a steady state. But once we are in the steady state is when we believe that one patient per month cadence is something that we continue to hear from the QTCs.

因此，我們正在等待其他中心也陸續啟動，才能更明確地說明何時會達到穩態。但一旦進入穩態，我們相信每月一位病患的節奏，仍是我們持續從QTC聽到的預期。

Okay. And given you've now seen both a low-yield batch and an out-of-spec batch, how should we think about the long-term success rate for manufacturing? Do you view this as like isolated incidents? Or do you think this could be something that we will see in future as well?

好的。另外，鑑於你們現在已經遇到一批低產量批次以及一批規格外批次，我們應該如何看待長期製造成功率？你們認為這是孤立事件嗎？還是你們認為未來也可能會再發生？

Thank you for that question. I mean, it's a little early. As you recall, our manufacturing experience in the clinical trials was a total of 11 patients treated, right? It's a very small data set. The -- and between the clinical trial as well as the subsequent clinical studies of Phase 3b and our manufacturing experience to date, the low-yield batch is the first time we've encountered.

謝謝你的問題。我的意思是，現在下結論還有點早。如你所記得，我們在臨床試驗中的製造經驗總共是治療了11位病患，對吧？這是一個非常小的資料集。而在臨床試驗以及後續的3b期臨床研究，加上我們迄今的製造經驗中，低產量批次是我們第一次遇到。

So up until this point, it looks like a low probability event. And there are several variables that cause such events that are related to variations in the incoming biopsy material. It could be related to the anatomic locations where biopsies are taken or a particular patient status or just the cellular yield that the growth characteristics that we derive out of any given biopsy.

因此截至目前，看起來這是一個低機率事件。造成此類事件有若干變數，與進廠活檢材料的差異有關。可能與取樣的解剖部位、特定病患狀態，或是我們從任何一份活檢中取得的細胞產量及其生長特性有關。

And given the limited experience, this is a rare event that we've seen that the cell yield was low. And fortunately, for us, whatever sheets were manufactured were used for patient treatment. It's just that it's below the threshold of billable unit.

在有限的經驗下，這是我們所見到的罕見事件——細胞產量偏低。幸運的是，無論製造出多少片（sheets），都已用於病患治療。只是其數量低於可計費單位的門檻。

Having said that, we continue to -- we're running a lot of process science on every manufacturing run that we conduct. And hopefully, with enough experience, we'll be able to point towards positive reasons why this may happen and how we can improve upon that.

話雖如此，我們仍持續——對我們進行的每一次製造批次都做大量的製程科學分析。希望累積足夠經驗後，我們能指出造成此情況的正向原因，並找出可改進之處。

But it's very hard to predict what such ratios could be. And since you asked about the out of spec, just wanted to take the opportunity to also mention what it was about. You may recall that there was one test that we never had in clinical development, which is the identity test which relates to the Pan-CK marker expression on keratinocytes.

但要預測這類比率會是多少非常困難。既然你問到規格外（out of spec），我也想藉此機會說明其內容。你可能記得，在臨床開發期間我們從未做過的一項檢測，是身分鑑別（identity）測試，與角質形成細胞上的Pan-CK標記表現有關。

And we -- since there was no clinical experience, the way in which thresholds or specifications were set for this test was based on six samples of five being healthy volunteers and one frozen RDEB samples that we had at the time of BLA review. This was not based on true GMP manufacturing run experience to set such specifications. And that was the test that failed. This has nothing to do with either the safety of the product or the potency of the product.

而我們——由於沒有臨床經驗，這項測試的門檻或規格設定方式，是基於在BLA審查時我們手上六個樣本：其中五個來自健康志願者，一個是當時我們持有的冷凍RDEB樣本。這並非基於真正的GMP製造批次經驗來設定這些規格。而失敗的就是這項測試。這與產品的安全性或效力（potency）完全無關。

So we are working with the agency to revisit whether the specifications that were set during the BLA review were appropriate or should we even relook at that, right? So some of these things will take some time and more experience to get concrete numbers to put on what should be our assumed rate of nonbillable units.

因此，我們正與主管機關合作，重新檢視在BLA審查期間所設定的規格是否適當，或是否應該重新評估，對吧？所以其中一些事情需要時間，也需要更多經驗，才能提出具體數字，來界定我們對不可計費單位比率的假設。

But if you look at overall numbers to date, for any autologous therapy that has been launched in the past, you will see such examples. And we'll continue to keep refining numbers and probabilities as we gain more experience there.

但如果你看截至目前的整體數據，任何過去已上市的自體療法（autologous therapy）都能看到類似案例。我們也會在累積更多經驗後，持續精煉相關數字與機率。

Stephen Willey, Stifel.

Stifel的Stephen Willey。

Can you remind us of the manufacturing yields that you're seeing in the commercial setting? I know you have the capacity for 12 sheets on a per patient basis, but what's the average number of sheets you've been able to manufacture for the patients you've treated thus far? And I guess, how does this differ, if at all, from the prior clinical trial experience? And I just have a follow-up.

你能提醒我們在商業化情境下看到的製造產量（yields）嗎？我知道你們每位病患的產能是12片（sheets），但就目前已治療的病患而言，平均能製造出多少片？另外，這與先前臨床試驗的經驗相比，有沒有任何差異？我也有一個追問。

Steve, the manufacturing yields from our commercial experience are actually -- they are very favorable when you compare it to what the clinical trial experience was. You may recall that for VIITAL, our Phase 3 trial, the maximum number of sheets that were allowed to be put on patients was six per patient. And in reality, it was about five sheets across the trial.

Steve，我們在商業化的製造產量其實——與臨床試驗經驗相比是非常有利的。你可能記得，在我們的3期試驗VIITAL中，每位病患允許貼用的最大片數是6片。而實際上，整個試驗平均大約是5片。

And right now, we are around nine sheets average per lot, which is a pretty healthy rate compared to what our clinical trial experience was. And therefore, which is why we're calling this an anomalous or a rare event that you had a low yield.

而目前我們每個批次（lot）的平均大約是9片，與臨床試驗經驗相比是相當健康的水準。因此，我們才會把你提到的低產量視為異常或罕見事件。

And of course, 12 is the maximum that we can supply, but we're learning from every batch and making sure that any indicators that tell us that you could have a certain type of yield, we're learning from that to adopt our process and put best practices in real time. So we're actually pleased by averaging nine sheets, which is a pretty substantial body area coverage.

當然，12 片是我們能供應的上限，但我們會從每一批次中學習，並確保任何顯示可能出現某種產率的指標，我們都會據此調整流程，並即時導入最佳實務。因此，我們其實對平均九片感到滿意，這代表相當可觀的體表面積覆蓋。

And then can you say what that low-yield number is that triggers your inability to not recognize revenue?

那麼你能否說明，觸發你們無法認列營收的那個低產率數字是多少？

Yes. Anything that is lesser than four sheets in a batch is a low-yield batch. So that's really our threshold. So three, two or one as per NDC is still on label, but it's -- for billing purposes, we will not recognize revenue for those batches.

可以。任何一個批次少於四片都屬於低產率批次。所以那就是我們的門檻。因此，依 NDC 規定，三片、兩片或一片仍符合標示（on label），但——就計費目的而言，我們不會對那些批次認列營收。

Okay. And then just with respect to the pan-CK marker assay that you mentioned on the keratinocyte side, where are you now in terms of engaging the agency around, I guess, either changing that number with a larger sample size or widening the confidence intervals?

了解。另外，關於你提到在角質形成細胞端的 pan-CK 標記檢測（marker assay），你們目前在與主管機關溝通方面進展到哪一步？我想是指，是否會在更大的樣本數下調整那個數值，或是放寬信賴區間？

Yes. We have had some interactions with the agency. The first thing was -- the first step was to make sure that we could treat the patient, which is why we had to go through some communications with the agency, and we were successful in treating the patient.

是的。我們已經與主管機關有過一些互動。第一件事——第一步——是確保我們能夠治療病人，這也是為什麼我們必須與主管機關進行一些溝通，而我們也成功完成了對病人的治療。

And I think from -- we should have more updates on where we are with the revision of the spec by the next quarterly update because we're still gathering the type of data. We're confident that the data that we have from our manufacturing runs in the GMP setting now justifies a lower specification from real-world experience versus something that was arbitrarily set based on limited experience during BLA review.

我認為，關於規格修訂（spec revision）的進展，我們應該會在下一次季度更新時提供更多資訊，因為我們仍在蒐集相關類型的數據。我們有信心，目前在 GMP 環境下製造運行所取得的數據，已能以真實世界經驗支持較低的規格要求，相較於在 BLA 審查期間基於有限經驗而任意設定的規格。

So it's a TBD how quickly this can be implemented because there are some mechanisms that are beyond our control and have with the FDA. So that's all I have for you at this point in time, but we will update you as in our subsequent quarters on this particular topic.

因此，這能多快落地仍待定（TBD），因為其中有一些機制超出我們的控制範圍，且涉及 FDA。目前我能提供的就到這裡，但我們會在後續季度就此特定議題向各位更新。

Ram Selvaraju, H.C. Wainwright.

Ram Selvaraju，H.C. Wainwright。

Congrats on all the progress made this quarter. I wanted to ask about last-minute cancellations, arbitrary withdrawals of patients from the process of ZEVASKYN treatment and how often you see that specifically occurring? So this has nothing to do with failures in manufacturing or inability to qualify of that.

恭喜本季度取得的所有進展。我想詢問關於臨近最後一刻的取消、病人從 ZEVASKYN 治療流程中任意退出的情況，以及你們具體看到這種情況發生的頻率如何？這與製造失敗或無法符合資格無關。

This specifically has to do with patients being unwilling to ultimately go through the treatment process, what we might call the arbitrary attrition rate. Just maybe you could give us some sense of how often that occurs based on current experience.

這特別是指病人最終不願意完成治療流程的情況，我們可以稱之為任意流失率（arbitrary attrition rate）。也許你們可以根據目前的經驗，讓我們了解這種情況大概多常發生。

Thanks for the question. Madhav?

謝謝你的提問。Madhav？

Yes. Well, so far, we have had two such events, right, as we mentioned, that has happened in terms of our record. So it's hard to predict, but if you look at the willingness for these patients to undergo the procedures, there's definitely a very strong willingness.

是的。到目前為止，我們確實發生過兩次這樣的事件，正如我們提到的，這是我們的紀錄。所以很難預測，但如果你看這些病人接受相關處置的意願，確實是非常強烈的。

But it's -- some of these things are -- if they are not able to make it because of illness or some health deterioration reasons, then we are talking about moving the biopsy date to some other date. It's not that the patients don't want to or are just backing off of the procedure itself.

但是——有些情況是——如果他們因為生病或健康惡化而無法如期進行，那我們談的是把活檢日期改到其他時間。並不是病人不想做，或是單純退出這個處置本身。

So I just want to be very clear with that, especially coming out from this Debra conference and SPD that I mentioned, we were just so energized. Literally seeing the number of patients that we've engaged with who were at our booth who are talking about ZEVASKYN. Some of them had the concern about what does the biopsy look like and what does the procedure look like.

所以我想把這點說得非常清楚，尤其是我提到的這次 Debra 會議與 SPD 之後，我們真的非常振奮。我們親眼看到與我們互動的病人數量，他們到我們的攤位、談論 ZEVASKYN。其中一些人會擔心活檢看起來是什麼樣子、處置流程是什麼樣子。

But we've had our people from the Strong Together Network who went through this procedure in clinical trials, sharing their own experiences, right? The product theater that we presented was also packed. We had room for more than 160 people, and there was a lot of interest in these product theaters to learn about the procedures and the outcome.

但我們有 Strong Together Network 的成員——他們在臨床試驗中接受過這個處置——分享他們自己的經驗，對吧？我們展示的產品劇場（product theater）也座無虛席。我們的場地可容納超過 160 人，而大家對這些產品劇場非常有興趣，想了解處置流程與結果。

So even if patients are dropping out for health deterioration reasons, we have not seen that these patients saying, oh, I don't want ZEVASKYN. It's a matter of rescheduling the biopsy to another date. And when that happens, especially in a quarterly report like this, when we talk about the number of slots with the number of patients, we are going to have different numbers for that particular finite period of time. And that's really how this current model is.

因此，即使病人因健康惡化而退出，我們也沒有看到病人說「噢，我不要 ZEVASKYN」。這只是把活檢改期到另一個日期。而當這種情況發生時，特別是在像這樣的季度報告中，當我們談到名額數與病人數時，在那個特定且有限的期間內，數字就會有所不同。這就是目前這個模型的運作方式。

So we are not saying that there is a patient attrition forever. We haven't seen that even with these two health reasons that we've talked about. And it's, therefore, what we reiterated our strategy. The more centers we have active, the more patients that are going through this process, the greater shots we will have a goal to be able to have these more number of patients treated in a given period of time.

所以我們不是在說病人會永久流失。即便是我們提到的這兩個健康因素案例，我們也沒有看到那樣的情況。因此，我們也再次強調我們的策略：越多中心啟動、越多病人進入這個流程，我們就越有機會在特定期間內讓更多病人完成治療。

So I just hope that offers a bit more clarity. I know you were asking about our ability to predict such movements, but it's hard to tell so far we've had two.

希望這能提供更清楚的說明。我知道你在問我們預測這類變動的能力，但目前很難判斷——到現在為止我們遇到兩次。

And then with respect to maximizing patient accessibility and convenience. You said during your prepared remarks that at this point, I believe you said almost half of the addressable patient population has in-state access to a qualified treatment center. So I was wondering if you could elaborate on this from two perspectives.

另外，關於最大化病人可近性與便利性。你在事先準備的發言中提到，目前我記得你說，幾乎有一半的可觸及病人族群在其所在州內就能取得合格治療中心的服務。所以我想請你從兩個角度進一步說明。

Firstly, how necessary you feel it needs to be for a patient to have in-state access to a qualified treatment center? And secondly, in order for the company to be able to provide this to the majority of patients or, say, 80% of the addressable patient population, how large would the qualified treatment center network theoretically have to be?

第一，你認為病人必須在州內就能取得合格治療中心的服務，這件事有多必要？第二，若公司要讓多數病人——例如可觸及病人族群的 80%——都能享有這樣的服務，理論上合格治療中心網絡需要多大規模？

Yes. Yes, great question. So the first question, importance of having a QTC in state. Earlier, we were talking about the payer mix, right?

是的。是的，這是個很好的問題。先回答第一個問題：在州內設有 QTC 的重要性。先前我們談到付款方組合（payer mix），對吧？

So one of the things here is when you have Medicaid, especially and when you have an in-state Medicaid patient, the access there is much faster relative to a patient traveling from an out of state and a physician needs to be enrolled in the host Medicaid state. So it actually helps to have a patient in the same state where you have a QTC just from an access standpoint.

其中一點是，當你面對 Medicaid，尤其是州內的 Medicaid 病人時，相較於病人跨州就醫，取得治療的速度會快得多；而且醫師還需要在接收州的 Medicaid 進行註冊。因此，從可近性角度來看，若病人與 QTC 在同一州，確實更有利。

The way we are saying that you have about 40% of our addressable patients are in state is based on our claims data when you count the number of claims that we have seen for patients in these states divided by the total number of claims across the country.

我們所說「約 40% 的可觸及病人在州內」的計算方式，是根據我們的理賠（claims）數據：以我們在這些州看到的病人理賠件數，除以全國總理賠件數。

It's not necessary to have a QTC in all of the states, and we will never have such scenario. We'll have so many QTCs because this is such a sided community, and we know patients travel from out of state. In fact, about, again, 40% roughly of the patient mix that a QTC has for some of our QTCs are coming from out of state. They are traveling 300, 400 miles away. And hence, we are dealing with leading EB centers.

並非有必要在所有州都設立 QTC，我們也不會出現那樣的情況。我們會有很多 QTC，因為這是一個相當集中的社群，而且我們知道病患會從外州前來就醫。事實上，再次強調，對於我們部分 QTC 而言，其病患組成中約有 40% 左右是來自外州。他們會遠行 300、400 英里。因此，我們正在與領先的 EB 中心合作。

So to get to that like 80% a number that you mentioned, we will still be able to get that. It's a matter of prioritization. Some of these in-state patients might get faster access as the centers are working to have clearance for out-of-state travels.

因此，要達到你提到的約 80% 這個數字，我們仍然能做到。這取決於優先順序的安排。在各中心努力取得外州旅行核准的同時，部分州內病患可能會更快獲得治療機會。

So far in the patients we have treated, as we mentioned on our prior quarterly call, we've actually had quite a few patients traveling from out of state already. So that mechanism already exists for people to travel and get treated.

截至目前我們已治療的病患，如同我們在上一季電話會議中提到的，我們其實已經有不少病患從外州前來。所以，人們跨州旅行接受治療的機制已經存在。

And then lastly, I was just wondering if you could just give us a sense of when you anticipate NTAP status to be reflected on two levels. Firstly, the revenue cadence and secondly, if you expect it to show up on the margin front? And if so, how?

最後，我想請你們談談你們預期 NTAP 身分會在兩個層面何時反映出來。第一是營收節奏，第二是你們是否預期會在毛利率/利潤率面反映？若會的話，會如何呈現？

On the revenue cadence, it really will depend on the payer of the patient. I mean, I think for Medicare beneficiaries because NTAP is going to really apply to Medicare beneficiaries, whether they are pure Medicare or dual eligible, sometimes you have patients that are Medicaid, Medicare.

就營收節奏而言，這確實取決於病患的付款方。我的意思是，對於 Medicare 受益人而言，因為 NTAP 主要適用於 Medicare 受益人，不論是純 Medicare 或同時符合雙重資格者；有時也會有病患同時具備 Medicaid、Medicare 身分。

So for those patients is where revenue actually is going to come in through. And in the absence of NTAP, these patients would have had really very limited access, if any. And now NTAP actually opens up that vital reimbursement for the centers. And then Vish, you have to.

因此，營收實際上會主要透過這些病患進來。而在沒有 NTAP 的情況下，這些病患即使有機會，能獲得的治療可近性也會非常有限。現在 NTAP 實際上為中心端打開了那項關鍵的給付。然後 Vish，你得……

Yes. So one more thing I wanted to add, Ram, about the NTAP status is it has two effects, right? The direct effect is, of course, for the 10% of our patient mix that is dependent on the Medicare reimbursement. So it's a small sliver of our TAM, so to speak.

是的。Ram，關於 NTAP 身分我還想補充一點：它有兩個影響，對吧？直接影響當然是針對我們病患組合中約 10% 依賴 Medicare 給付的部分。所以就某種意義而言，這只是我們 TAM（可服務總市場）中的一小塊。

However, the fact that we've built through this clinical rigor and gotten that NTAP status for those patients is also going to have a halo effect with other types of payers on how they view the technology because you have a validation here.

不過，我們透過這樣的臨床嚴謹性建立證據並取得這些病患的 NTAP 身分，對其他類型的付款方在看待這項技術時也會產生光環效應，因為這裡有一個驗證。

So that is definitely going to make it easier for centers, even for other types of patients to get the paperwork done. So we're hoping that, that will aid their payer negotiations and things like that.

因此，這肯定會讓中心端更容易完成文件作業，即使是針對其他類型的病患也是如此。所以我們希望這能協助他們與付款方的談判等事項。

In terms of -- you asked about the margin front. For us, it's not so much of a margin place more for the QTCs on are they going to be whole -- made whole. And that's where the NTAP plays a big role because currently for Medicare patients, as you know from the CAR-T world, without NTAP, it's a big P&L loss for a treating institution. And NTAP fills a big hole there. So that's what we hope will debottleneck treatment for some of these patients in these centers.

至於——你問到利潤率面。對我們而言，這與其說是我們的利潤率問題，不如說是對 QTC 而言，他們是否能「補足缺口」——也就是能否收支打平。而這正是 NTAP 扮演重要角色之處，因為目前對於 Medicare 病患，如同你從 CAR-T 領域所知，若沒有 NTAP，對治療機構而言會是很大的損益表虧損。而 NTAP 能補上那個很大的缺口。因此，我們希望這能在這些中心端為部分病患的治療去瓶頸。

Kristen Kluska, Cantor Fitzgerald.

Kristen Kluska，Cantor Fitzgerald。

So you mentioned in your prepared remarks that you want to have more patients enter the top of the funnel in case some of these situations arrive. I guess, which parts or issues could having more patients at the top of the tunnel potentially mitigate? And then which ones would this disruption still continue?

你在事先準備的發言中提到，你希望讓更多病患進入漏斗頂端，以防出現某些情況。我想問的是，漏斗頂端有更多病患，可能有助於緩解哪些環節或問題？另外，哪些問題即使如此仍會持續造成干擾？

Yes, I mean, I think it's top of the funnel. So things that are outside of our control, Kristen, is where we anticipate that, that's going to help mitigate, right? So for example, all of the topics we mentioned, if there is a movement of a biopsy date that needs to happen, if you have multiple patients across multiple centers that are aiming to have a biopsy, then that will help to offset and have more patients come through.

是的，我的意思是，關鍵在漏斗頂端。Kristen，對於那些我們無法控制的事情，我們預期這會有助於緩解，對吧？例如，我們提到的所有議題，如果需要調整活檢日期；若你在多個中心有多位病患都計畫進行活檢，這就能幫助抵消影響，讓更多病患能夠進入流程。

And it's essentially, it's having more shots at filling those manufacturing slots, which are finite in number. So that's really the whole purpose, plus also having more qualified treatment centers helps with the patient access, the travel, the amount of distance that they have to travel, these patients trust certain institutions, right, more than others.

本質上，這等於有更多機會去填滿那些製造產能時段（manufacturing slots），而這些時段的數量是有限的。所以這就是主要目的；此外，擁有更多合格治療中心也有助於病患可近性、旅行安排，以及他們必須移動的距離——病患對某些機構的信任度通常高於其他機構，對吧。

So we, therefore, want to increase that footprint. We also want physicians and actually, we're already seeing that. We recently engaged at the SPD through advisory meetings and the cross-pollination of best practices.

因此，我們希望擴大這個覆蓋範圍。我們也希望醫師——而且我們其實已經看到這點。我們最近在 SPD 透過諮詢會議以及最佳實務的交叉交流來進行互動。

The number of treatments, as we have more treatment centers come on board to bring the physicians together and have that cross-pollination is just helping greater dissemination of information. And that also helps with overall raising awareness and clinical conviction in ZEVASKYN. So it helps on multiple fronts, and that's exactly what we are currently in the process of doing.

隨著更多治療中心加入、把醫師聚集在一起並進行這種交叉交流，治療數量也在提升，因為這有助於更廣泛地傳播資訊。這也有助於整體提升對 ZEVASKYN 的認知與臨床信心。所以它在多個面向都有幫助，而這正是我們目前正在推進的事情。

Okay. Appreciate that. And given that some of these windows are very limited, is there -- like does it make any sense to do like patient screening when they come in for biopsies or anything, make sure that they're healthy? I know you can't prevent 100% of the time them from getting sick and potentially meaning to cancel, but can this mitigate it at all?

好的。感謝說明。鑑於其中一些時間窗口非常有限，是否——例如在病患來做活檢時進行病患篩檢之類的，確認他們身體狀況良好，這樣做有意義嗎？我知道你們不可能 100% 防止他們生病而可能需要取消，但這能在某種程度上降低風險嗎？

Potentially, right, these examples that we gave for the two patients that had to cancel their biopsies happen very close to their biopsy. In fact, one was on the day of biopsy that they said, I can't travel to the site and very sick. And the other example was like a day or two.

有可能，對吧？我們舉的那兩位必須取消活檢的病患案例，都是在非常接近活檢時間點才發生。事實上，其中一位是在活檢當天表示自己無法前往中心，且病得很重。另一個案例則大概是提前一兩天。

You have that close to the biopsy date last minute, it's very hard to make adjustments. Whereas if you have this information like two, three weeks in advance, that's definitely something else and that's where to your first question, if you have more patients on the top of the funnel, you have more flexibility or shots on goal that you may be able to move some patients and adjust date.

如果是在如此接近活檢日期的最後一刻，就很難做出調整。相較之下，如果你能提前兩到三週掌握這些資訊，那就完全不同；也回到你第一個問題，如果漏斗頂端有更多病患，你就有更大的彈性或更多「射門機會」，可能可以調整部分病患並更改日期。

If you only have one or two, those idiosyncratic examples will just take over, we don't have reaction time to make amend. So that's really where it is, and we'll continue to monitor and hopefully, they are all not last-minute cancellations, and we learned some ways to mitigate it as we go through more such examples.

如果只有一兩位病患，這些個別的特殊情況就會主導結果，我們沒有反應時間去做修正。所以重點就在這裡；我們會持續監測，並希望不會都是最後一刻取消，同時也會在遇到更多類似案例的過程中學到一些降低風險的方法。

David Bautz, Zacks Small-Cap Research.

David Bautz，Zacks 小型股研究。

So my first one is just about clearing up the revenue recognition. So if I understand correctly, you said that two of the patients you didn't record revenue for, but I believe those two patients were still treated. So is this a case where the company is just going to incur the full treatment of manufacturing costs? Or is there going to be a chance to recognize revenue for those two patients at a later date, the former.

我第一個問題是想釐清營收認列。如果我理解正確，您說有兩位病患您們沒有認列營收，但我相信那兩位病患仍然接受了治療。所以這是否代表公司將承擔完整治療的製造成本？或者是否有機會在日後對那兩位病患認列營收（前者）？

We will not be recognizing revenue for those two treatments because that is our agreement, right? I mean whether it's a low yield or if it's an out of spec, we basically eat up the COGS.

我們不會為那兩次治療認列營收，因為那是我們的協議，對吧？我的意思是，不論是低產出（low yield）或是不符合規格（out of spec），基本上我們會自行吸收銷貨成本（COGS）。

Okay. So the Q2 gross margins look like they were about 63%. So as the manufacturing process becomes a bit more predictable, where do you see the normalized gross margin settling?

了解。所以第二季的毛利率看起來大約是 63%。隨著製造流程變得更可預測，您認為正常化的毛利率會落在什麼水準？

Yes. So our gross margins are heavily dependent on the number of patients that get treated in a given quarter, mainly because most of our manufacturing costs are fixed. So with higher volumes, then our margins will improve. And we think standard state would be probably about 85% to 90% once we reach full operating capacity.

是的。所以我們的毛利率高度取決於某一季接受治療的病患人數，主要是因為我們大部分的製造成本是固定的。因此，量越高，我們的毛利率就會改善。我們認為在達到滿載營運產能後，穩態大概會在 85% 到 90% 左右。

Okay. Great. And then lastly, can you give any additional details on the patient funnel where it stands today? How many patients use ID or even biopsy or treat in to QTCs? Any of those type of numbers would be really helpful.

好的。很好。最後，您能否提供更多關於目前病患漏斗（patient funnel）的細節？有多少病患使用 ID、甚至已做活檢或已進入 QTC 接受治療？任何這類數字都會非常有幫助。

Yes. David, I mean, definitely, patients are interested. We know that there are identified patients on our prior calls, we had mentioned about more than 100 patients that have been identified by their community physicians and QTCs that are considered clinically eligible. There are certainly multiple other steps, right, downstream steps about consultation and funneling these patients. So that's all happening.

可以。David，我的意思是，病患確實有興趣。我們知道有已辨識出的病患；在先前的電話會議中我們提到，社區醫師與 QTC 已辨識出超過 100 位被認為臨床上符合資格的病患。當然，後續還有多個步驟，對吧，包括諮詢以及將這些病患導入漏斗的流程。所以這些都正在進行中。

I think for us, like we mentioned on this call, the -- really the rate-limiting step is at the qualified treatment center and advancing these patients through the treatment process. So as that continues to happen, we continue to believe there are patients that are going to move through, especially in light of some of the more recent interactions we've had with patients and physicians. So I'm not able to provide any particular numbers, but we see that movement happening.

我想對我們而言，如同我們在這通電話中提到的——真正的瓶頸是在合格治療中心（QTC），以及推進這些病患完成治療流程。因此，隨著這件事持續發生，我們仍然相信會有病患往前推進，特別是考量到我們近期與病患及醫師的一些互動。所以我無法提供任何具體數字，但我們確實看到這種進展正在發生。

(Operator Instructions) Fanyi Zhong, Oppenheimer.

(接線員指示) Oppenheimer 的 Fanyi Zhong。

This is Fanyi for Jeff Jones from Oppenheimer. Maybe a clarification question. When you indicated you had a low yield, so revenue was not recognized for two patients. Does that mean the patient is unable to receive any treatment or there is sufficient material for partial treatment? So what happens in that scenario?

我是 Oppenheimer 的 Fanyi，代替 Jeff Jones 提問。可能是一個釐清問題。當您提到出現低產出，因此兩位病患未認列營收時，這是否表示病患無法接受任何治療，或是有足夠材料可進行部分治療？在那種情況下會怎麼處理？

And the second question is, do you have a view for how long for new QTCs to begin treating patients?

第二個問題是，您對新的 QTC 需要多久才能開始治療病患，有沒有看法？

Just wanted to clarify that the two cases where we did not recognize revenue were two different cases. One was a low-yield issue and the other one was an out of spec. They're slightly different in nature. But in -- just to be clear, revenue was not recognized for either of those, but the patient was treated. Whatever sheets we produced and provided to the treatment center, the patients were treated.

想先釐清一下，我們未認列營收的兩個案例其實是兩種不同情況。一個是低產出問題，另一個是不符合規格（out of spec）。性質略有不同。但為了清楚起見，這兩個案例都沒有認列營收，不過病患都有接受治療。我們製作並提供給治療中心的任何片材（sheets），病患都用來接受治療了。

So they received treatment, and we're hoping that the patients receive the clinical benefit and that experience will grow with these treatments. But revenue has not been recognized and will not be recognized for those two particular treatments.

所以他們確實接受了治療，我們也希望病患能獲得臨床效益，而這些治療的經驗會持續累積。但那兩次特定治療的營收沒有認列，且未來也不會認列。

Your second question was about how much time does it take to activate a QTC and get to patient treatment. And we had previously indicated this is about an average four to six months, but then the problem is with averages are not useful when the variance is so high.

您的第二個問題是，啟用一個 QTC 並開始治療病患需要多久時間。我們先前曾表示平均約四到六個月，但平均值的問題在於，當變異度很高時其實不太有用。

And you have examples we just gave you today where CHOP was activated in May, and they treated a patient in July. So that was a very quick turnaround, whereas we have had other sites that have 12 months since activation and not treated a single patient. So just because of this variability, it's very hard to predict.

例如我們今天剛給的例子：CHOP 在 5 月啟用，並在 7 月就治療了一位病患。那是非常快的周轉；但我們也有其他據點，啟用後已經 12 個月仍未治療任何一位病患。因此，由於這種差異性，很難預測。

And the reasons are manyfold. It has got to do with the types of payer mixes in certain states and the paperwork that patients have to go through and various such factors. So it will take us a little bit more time to try to thematize and put any numbers to what is a reasonable time that you can expect that a site will take between getting active and treating a patient.

原因有很多。包括某些州的付款方組合（payer mix）類型、病患必須完成的文件流程，以及各種這類因素。因此，我們還需要一些時間來嘗試歸納主題，並量化一個合理的時間範圍：從據點啟用到治療第一位病患，通常需要多久。

However, we are learning from these experiences and the more recent activations that we're seeing, sites are already talking to patients and trying to line up every part of the process that can be pre-lined up before even activation. So that is something that we're seeing sites starting to do, but we'll have to wait and see how much that accelerates this time period.

不過，我們正在從這些經驗中學習；而且從近期的啟用情況來看，各據點在正式啟用前就已經開始與病患溝通，並嘗試把流程中所有能事先安排的部分先行到位。所以我們看到據點開始這麼做，但仍需觀察這能在多大程度上加速整體時間。

I hope that answers your question?

希望這回答了您的問題？

Thank you very much. Well, we appear to have reached the end of our question-and-answer session. I will now turn the call back over to Vish for any closing comments.

非常感謝。看起來我們已經到了問答環節的尾聲。我現在把電話交回給 Vish，請他做結語。

Thank you, Jenny. I'd like to thank everyone for joining us for today's business update, and we'll talk to you again soon.

謝謝你，Jenny。感謝各位參加今天的業務更新，我們很快會再與各位通話。

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

非常感謝。今天的電話會議到此結束。您現在可以掛斷電話線，祝您有美好的一天。感謝您的參與。