Abeona Therapeutics Inc (ABEO) 2025 Q4 法說會逐字稿

Good morning, everyone, and welcome to the Abeona Therapeutics full-year 2025 results conference call. (Operator Instructions) Please note, this conference is being recorded.

各位早安，歡迎參加 Abeona Therapeutics 2025 全年業績電話會議。(接線員指示) 請注意，本次會議將被錄音。

During this call, we will refer to the press release issued this morning announcing the financial results, which is available on our corporate website at www.abeonatherapeutics.com. 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 law.

在本次電話會議中，我們將提及今早發布、公告財務結果的新聞稿，該新聞稿可於我們公司網站 www.abeonatherapeutics.com 取得。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，且可能變更。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有重大差異，包括但不限於我們在 Form 10-K 及向美國證券交易委員會提交的定期報告中所列之因素。這些文件可於我們網站 www.abeonatherapeutics.com 取得。

Joining us on today's call with prepared remarks are Dr. Vish Seshadri, Chief Executive Officer; and Dr. Madhav Vasanthavada, Chief Commercial Officer; Joe Vazzano, Chief Financial Officer; and Brian Kevany, Chief Technical Officer. After the prepared remarks, we will conduct a question and answer session.

今天與我們一同出席並發表準備講稿的有：執行長 Vish Seshadri 博士；商務長 Madhav Vasanthavada 博士；財務長 Joe Vazzano；以及技術長 Brian Kevany。在準備講稿之後，我們將進行問答環節。

So with that, I will now turn the call over to Vish Seshadri to lead us off. Vish, over to you.

那麼，接下來我把電話交給 Vish Seshadri 開場。Vish，交給你。

Thank you, Jenny, and good morning, everyone. We continue to see growing patient demand for ZEVASKYN, the first and only autologous cell-based gene therapy for the treatment of adult and pediatric patients with recessive dystrophic epidermolysis bullosa or RDEB.

謝謝你，Jenny，各位早安。我們持續看到患者對 ZEVASKYN 的需求日益增加；ZEVASKYN 是首個且目前唯一的自體細胞基因療法，用於治療患有隱性營養不良型表皮分離性水皰症（recessive dystrophic epidermolysis bullosa，RDEB）的成人與兒科患者。

As a reminder, ZEVASKYN was approved in April 2025, but our launch was delayed to quarter four, 2025 as we optimized a sterility test that was required for product release. Treating our first commercial patient this past December was a significant milestone for Abeona, but 2026 is where the launch execution ramps up. We aren't just looking at one-off successes anymore. We're focused on building a consistent cadence of biopsies, product delivery and treatments.

提醒各位，ZEVASKYN 於 2025 年 4 月獲准，但由於我們為產品放行而優化一項所需的無菌檢測，上市推進延後至 2025 年第四季。去年 12 月治療我們第一位商業患者是 Abeona 的重要里程碑，但 2026 年才是上市執行加速推進的一年。我們不再只看單次成功。我們專注於建立穩定的節奏：活檢、產品交付與治療。

Since resuming manufacturing in late January after our annual shutdown, we've treated one patient this quarter, biopsied three additional patients with treatment scheduled over the coming weeks and expect to perform additional biopsies this month. All patient treatments and biopsies performed to date have come from the first two of our four qualified treatment centers, Lurie Children's Hospital in Chicago and Lucile Packard Children's Hospital at Stanford.

自 1 月下旬在年度停工後恢復製造以來，我們本季已治療 1 名患者，並為另外 3 名患者進行活檢，預計在未來幾週內安排治療，且我們預期本月將進行更多活檢。截至目前為止，所有患者治療與活檢皆來自我們四個合格治療中心（QTC）中的前兩個：芝加哥的 Lurie 兒童醫院與史丹佛的 Lucile Packard 兒童醫院。

As our third and fourth QTCs, which are Children's Hospital of Colorado and UTMB at Galveston, Texas, also begin to schedule their patients into upcoming biopsy slots, we anticipate a healthy cadence of patient biopsies in the coming months. This momentum provides Abeona the opportunity to demonstrate that the operational machine behind ZEVASKYN works at scale from initial biopsy through final delivery.

隨著我們第三與第四個 QTC——科羅拉多兒童醫院以及德州加爾維斯頓的 UTMB——也開始為其患者安排即將到來的活檢時段，我們預期未來數月患者活檢將維持健康的節奏。這股動能讓 Abeona 有機會證明，支撐 ZEVASKYN 的營運體系能以規模化方式運作，從最初活檢到最終交付皆然。

At the same time, we are hyper-focused on ensuring a seamless experience for every patient in the ZEVASKYN treatment journey, and we are building a foundation of operational excellence that resonates with this closed-knit RDEB community. We recognize that in this patient-driven market, providing a smooth journey is the most effective way to catalyze the organic demand needed to scale ZEVASKYN in 2026 and beyond.

同時，我們高度專注於確保每位患者在 ZEVASKYN 治療旅程中都能獲得無縫的體驗，並建立能與這個緊密連結的 RDEB 社群產生共鳴的卓越營運基礎。我們認知到，在這個由患者驅動的市場中，提供順暢的就醫旅程，是催化 2026 年及其後擴大 ZEVASKYN 所需自然需求的最有效方式。

To further elaborate on how our launch is gathering momentum, I'll now hand the call to our Chief Commercial Officer, Dr. Madhav Basantavada, to review the commercial update. Madhav?

為進一步說明我們的上市如何累積動能，我現在把電話交給我們的商務長 Madhav Basantavada 博士，請他說明商業最新進展。Madhav？

Thank you, Vish, and hello, everyone. Demand for ZEVASKYN continues to grow. We previously had reported that nearly 50 potentially eligible patients were identified across our initial qualified treatment centers and community-based physicians. Starting this year, we have deployed a field team that has been engaging with community physicians and the number of identified eligible ZEVASKYN patients has now grown to more than 100.

謝謝你，Vish，各位好。ZEVASKYN 的需求持續成長。我們先前曾報告，在我們最初的合格治療中心以及社區醫師之間，已辨識出近 50 名可能符合資格的患者。自今年起，我們部署了一支外勤團隊與社區醫師互動，目前已辨識出的符合 ZEVASKYN 資格患者人數已成長至超過 100 名。

While demand continues to grow, the speed at which identified patients receive ZEVASKYN treatment has significantly varied during these initial months of launch, but the momentum is picking up. Since our launch in Q4 2025, two patients have been treated with ZEVASKYN. Three additional patients have been biopsied for treatment over the coming weeks, and we expect to biopsy additional patients this month.

儘管需求持續成長，但在上市初期的這幾個月中，已辨識患者實際接受 ZEVASKYN 治療的速度差異相當大，不過動能正在提升。自 2025 年第四季上市以來，已有 2 名患者接受 ZEVASKYN 治療。另有 3 名患者已完成活檢，預計在未來幾週內接受治療，我們也預期本月將為更多患者進行活檢。

Currently, we also know of at least 10 more patients who are advancing through the administrative process and targeting a second quarter 2026 biopsy. As Vish mentioned, the patient treatments and biopsies until now have all come from the first two QTCs that were activated in the middle of last year.

目前，我們也知道至少還有 10 名患者正在推進行政流程，目標是在 2026 年第二季進行活檢。如 Vish 所提到，截至目前的患者治療與活檢皆來自去年年中啟動的前兩個 QTC。

While it has taken a long time to move the very first patients through the funnel to treatment, we have not seen patient attrition during this process and no payers so far have denied insurance coverage for ZEVASKYN, reflecting the strong value ZEVASKYN offers to this patient community.

雖然將最初的患者從漏斗推進到治療花了很長時間，但我們在此過程中未見患者流失，且迄今沒有任何付款方拒絕 ZEVASKYN 的保險給付，反映出 ZEVASKYN 對此患者社群所提供的強勁價值。

As QTCs and payers treat more patients and gain experience with the overall process, we expect the speed of patient treatment to go faster. Additionally, as the remaining two QTCs treat patients, we anticipate that the number of ZEVASKYN treatments will grow in the coming quarters.

隨著 QTC 與付款方治療更多患者並累積整體流程經驗，我們預期患者治療的速度將加快。此外，隨著其餘兩個 QTC 開始治療患者，我們預期未來幾季 ZEVASKYN 的治療人數將成長。

Now regarding activating additional QTCs for ZEVASKYN, becoming a QTC is a multistep process that starts with a dermatologist who is an EB specialist, championing ZEVASKYN at their institution and requires a buy-in and sign-off from various functions and committees all the way to the level of CEO or CFO of that institution.

接著談到為 ZEVASKYN 啟動更多 QTC：成為 QTC 是一個多步驟流程，起始於一位身為 EB 專科的皮膚科醫師在其機構內倡議推動 ZEVASKYN，並需要各項職能與委員會的支持與簽核，一路到該機構的執行長或財務長層級。

Once the decision is made to become a QTC, several moving parts, including a master service agreement, trade policy, clinical training for biopsy and treatment and registry protocols with IRB approvals must be put into place. That makes QTC onboarding a several month process.

一旦決定成為 QTC，就必須到位多個環節，包括主服務協議、交易政策、活檢與治療的臨床訓練，以及取得 IRB 核准的登錄研究（registry）方案等。因此，QTC 的導入（onboarding）通常需要數個月。

Once the site is activated, it may then begin patient consultations for ZEVASKYN, work with insurers to secure clinical authorizations and financial commitment for that individual patient and then schedule patients for biopsy. As mentioned earlier, we have four QTCs activated, two have started treating patients and the other two have patients that are moving through the administrative process to schedule a biopsy.

當據點啟動後，即可開始為 ZEVASKYN 進行患者諮詢，與保險方合作以取得該名患者的臨床授權與財務承諾，並接著安排患者進行活檢。如先前所述，我們已啟動 4 個 QTC，其中 2 個已開始治療患者，另外 2 個則有患者正在推進行政流程以安排活檢。

In addition to the four current QTCs, we are actively working toward onboarding five additional centers and are in various stages of the site onboarding process. To ensure a geographically expansive footprint, our goal is to have at least seven QTCs active by the end of 2026.

除目前的 4 個 QTC 外，我們也正積極推進另外 5 個中心的導入，且正處於據點導入流程的不同階段。為確保具備地理上廣泛的佈局，我們的目標是在 2026 年底前至少啟動 7 個 QTC。

Lastly, on the market access front, I would like to reiterate that all major commercial payers, including UnitedHealthcare, Cigna, Aetna, Anthem and most Blue Cross Blue Shield plans have published coverage policies for ZEVASKYN, representing roughly 80% of commercially covered lives.

最後，在市場准入方面，我想重申，所有主要商業保險支付方，包括 UnitedHealthcare、Cigna、Aetna、Anthem 以及多數 Blue Cross Blue Shield 計畫，均已發布 ZEVASKYN 的給付涵蓋政策，約涵蓋 80% 的商業保險承保人群。

ZEVASKYN also has baseline coverage across all Medicaid programs for all 50 states. In addition, CMS has established a permanent HCPCS J-code for ZEVASKYN effective January 1, 2026. We expect the J-code to be an important enabler for streamlined billing and reimbursement for QTCs.

ZEVASKYN 也在全美 50 州的所有 Medicaid 計畫中具備基礎給付涵蓋。此外，CMS 已為 ZEVASKYN 建立永久性的 HCPCS J-code，自 2026 年 1 月 1 日起生效。我們預期該 J-code 將成為 QTCs 簡化開立帳單與給付報銷流程的重要推動因素。

Ultimately, every step forward, every biopsy, every treatment, every positive patient story strengthens our confidence in the impact ZEVASKYN can have. We are energized by the early momentum and remain committed to delivering a seamless ZEVASKYN experience.

最終而言，每向前一步、每一次活檢、每一次治療、每一則正向的病患故事，都強化了我們對 ZEVASKYN 可能帶來影響的信心。我們對早期動能感到振奮，並將持續致力於提供順暢無縫的 ZEVASKYN 體驗。

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

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。Joe？

I would like to remind everyone that you can find additional details on our financial results for the year ended December 31, 2025, in our most recent Form 10-K. Starting with statements of operations. Total revenue for the year ending December 31, 2025, was $5.8 million. Total revenue includes $3.4 million in license and other revenues and $2.4 million in net product revenue.

我想提醒各位，關於截至 2025 年 12 月 31 日止年度的財務結果更多細節，可在我們最新的 Form 10-K 中查閱。先從損益表開始。截至 2025 年 12 月 31 日止年度的總營收為 580 萬美元。總營收包含 340 萬美元的授權及其他收入，以及 240 萬美元的產品淨收入。

License and other revenues were primarily driven by a clinical milestone of $3 million achieved in the fourth quarter of 2025 under our sublicense agreement for Rett syndrome with Taysha Gene Therapies. Net product revenue reflects the patient treatment in December. The patient treated was a Medicaid patient.

授權及其他收入主要來自我們與 Taysha Gene Therapies 就 Rett 氏症候群簽訂的再授權協議中，於 2025 年第四季達成的一項 300 萬美元臨床里程碑。產品淨收入反映了 12 月的病患治療。該名接受治療的病患為 Medicaid 病患。

We expect our average net revenues to normalize over time as the payer mix expands to include commercially insured patients. We received payment for this treatment in the first quarter of 2026. Cost of sales for 2025 was $1.5 million, primarily driven by the first commercial ZEVASKYN treatment in December.

隨著支付方組合擴大並納入商業保險病患，我們預期平均淨收入將隨時間推移而趨於正常化。我們已於 2026 年第一季收到該次治療的款項。2025 年銷貨成本為 150 萬美元，主要由 12 月首例商業化 ZEVASKYN 治療所帶動。

Cost of sales also includes the cost from the August production batch that was not released due to technical challenges related to an FDA-mandated rapid sterility lot release assay. As more patients are treated, we expect our gross margins to increase significantly with better economies of scale related to production costs.

銷貨成本亦包含 8 月生產批次的成本；該批次因與 FDA 要求的快速無菌放行批次檢測（lot release assay）相關之技術挑戰而未能放行。隨著更多病患接受治療，我們預期在生產成本規模經濟改善下，毛利率將顯著提升。

Total research and development or R&D spending for 2025 decreased $7.6 million to $26.8 million compared to $34.4 million in 2024. This reduction was primarily driven by the April 2025 FDA approval of ZEVASKYN, which resulted in certain production costs being capitalized into inventory and engineering runs that are no longer classified as R&D expense.

2025 年研發（R&D）總支出較 2024 年的 3,440 萬美元減少 760 萬美元至 2,680 萬美元。此一下降主要由 2025 年 4 月 FDA 核准 ZEVASKYN 所致，使得部分生產成本得以資本化計入存貨，且工程批次（engineering runs）不再被歸類為研發費用。

Selling, general and administrative or SG&A expenses for 2025 were $65 million, an increase of $35.1 million over 2024. This increase primarily reflects Abeona's commercial transition following the April 2025 FDA approval of ZEVASKYN, including $18.6 million in personnel and stock-based compensation and $2.3 million in direct commercialization costs.

2025 年銷售、一般及行政（SG&A）費用為 6,500 萬美元，較 2024 年增加 3,510 萬美元。此一增加主要反映 Abeona 在 2025 年 4 月 FDA 核准 ZEVASKYN 後的商業化轉型，包括 1,860 萬美元的人員與股份基礎給付，以及 230 萬美元的直接商業化成本。

Additionally, certain engineering and training expenses previously classified as R&D were transitioned to SG&A post approval. In May of 2025, we sold our rare pediatric disease priority review voucher awarded following the FDA approval of ZEVASKYN. The company recorded a $152.4 million gain on sale from this transaction after receiving payment in June of 2025.

此外，部分先前歸類為研發的工程與訓練費用，在核准後轉列為 SG&A。2025 年 5 月，我們出售了因 ZEVASKYN 獲 FDA 核准而取得的罕見兒科疾病優先審查憑證（priority review voucher）。公司於 2025 年 6 月收到款項後，就此交易認列 1.524 億美元的出售利益。

Net income was $71.2 million for the year ended December 31, 2025, or $1.34 per basic and $1.01 per diluted common share. Net loss in 2024 was $63.7 million or $1.55 loss per basic and diluted common share. As of December 31, 2025, cash, cash equivalents and short-term investments totaled $191.4 million.

截至 2025 年 12 月 31 日止年度，淨利為 7,120 萬美元，或每股基本普通股盈餘 1.34 美元、每股稀釋普通股盈餘 1.01 美元。2024 年淨損為 6,370 萬美元，或每股基本及稀釋普通股虧損 1.55 美元。截至 2025 年 12 月 31 日，現金、約當現金及短期投資合計為 1.914 億美元。

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

接下來，我將把電話會議交回給 Vish，在開放問答前補充說明。

Thank you, Joe. In closing, I want to reiterate that while 2025 gave us our first commercial proof of concept, 2026 is about solidifying our commercial blueprint. I'm incredibly proud of the entire Abeona team from our manufacturing and quality groups, ensuring every lot meets our highest standards to our commercial and clinical teams supporting our treatment centers.

謝謝你，Joe。最後我想再次強調，雖然 2025 年為我們帶來首個商業化概念驗證（proof of concept），但 2026 年的重點在於鞏固我們的商業化藍圖。我為 Abeona 全體團隊感到無比自豪，從製造與品質團隊確保每一批次都符合我們最高標準，到商業與臨床團隊支援我們的治療中心。

Every person in this company is focused on ensuring that RDEB community's experience with ZEVASKYN is nothing short of excellent. We are doing the heavy lifting now to get these foundations right, and I'm confident that this collective focus on execution today is what will allow us to scale aggressively and deliver meaningful value in the quarters and years to come.

公司每一位成員都專注於確保 RDEB 社群對 ZEVASKYN 的體驗絕對出色。我們現在正投入大量心力把這些基礎打牢，我相信今日對執行力的集體專注，將使我們能在未來幾季與幾年積極擴張並交付具意義的價值。

We look forward to providing updates on our continued progress on our first quarter 2026 conference call. With that, I'll turn the call over to Jenny to open it up for Q&A. Thanks, Jenny.

我們期待在 2026 年第一季電話會議中，提供我們持續進展的最新資訊。接下來，我將把電話會議交給 Jenny 以開放問答。謝謝，Jenny。

(Operator Instructions) Ram Selvaraju, H.C. Wainwright.

(接線員指示) Ram Selvaraju，H.C. Wainwright。

Congratulations on all the recent progress. I was wondering if you could comment on the cadence with which qualified treatment centers are likely to be stood up in the coming months? And any specific factors that might influence the speed with which that occurs, if you expect that pace to increase? And if so, what might be the specific contributing factors to that?

恭喜近期取得的各項進展。我想請問，未來幾個月內合格治療中心（QTCs）預計會以何種節奏陸續建置到位？以及是否有任何特定因素可能影響建置速度、您是否預期該節奏會加快？若會加快，可能的具體促成因素是什麼？

Secondly, I was wondering if you could comment on the specific drivers of R&D spending over the course of 2026 and beyond. And if we should expect R&D spend to modulate somewhat over the course of the coming quarters or if, in fact, you expect any noteworthy increases over the remainder of 2026?

第二個問題，我想請您談談 2026 年及之後研發支出的具體驅動因素。我們是否應預期未來幾季研發支出會有所調整，或是您預期在 2026 年剩餘期間會出現任何值得注意的增加？

Thank you for the questions. Regarding the cadence with the QTCs and the speed of ramp-up, right? I think there are a lot of factors that go in. We have some preliminary viewpoint just beginning this quarter. I'll turn it over to Madhav to articulate and knowing that our projections are based on the first two sites just about ramping up, right? So Madhav, why don't you take that one?

謝謝你的提問。關於 QTCs 的節奏與爬坡速度，對吧？我認為其中牽涉很多因素。我們在本季才剛開始有一些初步觀點。我把問題交給 Madhav 來說明；也請理解，我們的預測是以前兩個站點剛開始爬坡為基礎，對吧？所以 Madhav，你來回答這題吧？

Yeah. Thanks, Ram, for the question. So with regard to QTCs, as I mentioned, we are working with five centers, one of whom is imminent, and we expect to hopefully announce it in this coming quarter. And then centers are in varying stages of their onboarding process. Our goal is to have seven in total active by the end of the year.

好的。謝謝你，Ram，這個問題。關於 QTCs，如我提到的，我們正與五個中心合作，其中一個即將到位，我們希望能在本季宣布。而其他中心則處於導入（onboarding）流程的不同階段。我們的目標是在年底前總計有七個中心正式啟用。

In terms of the aspects that drive the speed with which the centers come on board, there are various ones. Some centers wanted to obviously wait for ZEVASKYN approval to take place before they invested additional resources. Some started looking at their payer mix like of the individual sort of patients that are in their treatment sort of pool to see what kind of payer mix exist, how many are commercially insured patients and if Medicaid, what sort of is the out-of-state Medicaid nuances there.

就推動各中心上線速度的面向而言，因素有很多。有些中心顯然希望等到 ZEVASKYN 獲批之後，才投入額外資源。有些中心則開始檢視其付款方組合，也就是其治療患者池中的個別患者類型，看看付款方組合是什麼樣子、有多少是商業保險患者；若是 Medicaid，則還要看跨州 Medicaid 的各種細微差異。

And they essentially were also waiting to see coverage established. But now we have covered significant ground with regard to market access, having established coverage and these payer policies are also in place. So that has given great confidence for these sites to initiate their process and speed that up.

而且他們基本上也在等待看到保險給付被建立起來。但現在我們在市場准入方面已經取得了相當大的進展，已建立給付，且這些付款方政策也已到位。因此，這讓這些據點更有信心啟動流程並加快速度。

And then there are other factors with regard to institutional bureaucracies that exist with every institution, people getting to understand the cell and gene therapy units because in the dermatology space, this is the first engineered cell therapy that we are moving to treatment space.

另外還有一些因素與各機構都存在的制度性官僚流程有關，例如讓大家理解細胞與基因治療單位；因為在皮膚科領域，這是我們推進到治療端的第一個工程化細胞療法。

And so that requires greater cross-functional interaction. But we have learned a lot in onboarding the previous four centers, and our teams are doing a tremendous job in helping the upcoming centers to navigate that pathway and bring them to speed.

因此這需要更高程度的跨職能互動。但我們在先前四個中心的導入過程中學到很多，而我們的團隊也做得非常出色，協助即將上線的中心走完這條路徑並快速到位。

So we think we are confident about having seven in total. And if additional centers move faster, then yes, of course, we will be able to help them stand up sooner. I hope that gives some flavor.

所以我們對總計達到七個中心很有信心。如果有其他中心進展更快，那當然，我們也能協助他們更早建置並上線。希望這能讓你有一些概念。

Yeah. And just to add to that, right, Ram, you said at steady state, what we anticipate is sites have communicated to us that one patient a month is kind of a cadence that we can definitely do. Some sites are saying perhaps two patients a month. So I think it's just a matter of -- we're projecting based on what we are hearing from the sites in terms of their plans and their patient visibility. We need to see that come through, right?

是的。再補充一下，對吧，Ram，你提到在穩態下，我們預期各據點已向我們表示，每月一位患者是我們肯定能做到的節奏。有些據點則說也許每月兩位患者。所以我認為這只是——我們是根據據點告訴我們的計畫與其患者能見度來做預測。我們需要看到這些實際落地，對吧？

I think we'll be able to give more evidence-based cadence and the speed of getting there once we start seeing that steady state. We need to see three consecutive months of delivering that consistently. I think that's really what we're looking to get to by midyear. But as also we articulated, two of our four sites are yet to reach the point where they start layering their patients because the upfront setup time is what they're taking right now.

我想一旦我們開始看到那個穩態，我們就能提供更以證據為基礎的節奏與達成速度。我們需要連續三個月都能穩定交付。我想這正是我們希望在年中前達到的。但如同我們也說過的，我們四個據點中有兩個尚未到開始疊加患者的階段，因為他們目前正在投入前期建置時間。

Hopefully, that comes through in the second quarter, and we're able to show with data that, okay, sites are reaching their kind of cruise control level of speed, and therefore, this is more predictable. So I hope that helps there.

希望第二季能看到進展，並且我們能用數據證明：好，據點已達到某種「定速巡航」的速度水準，因此可預測性更高。希望這能有所幫助。

Regarding your second question about R&D spending, right? Let me open it up to Joe first to just give a little bit because we're so focused on ZEVASKYN launch right now that our R&D spend is almost insignificant. But Joe, why don't you go ahead?

關於你第二個問題，也就是研發支出，對吧？我先請 Joe 簡單說明一下，因為我們現在非常專注於 ZEVASKYN 的上市推進，所以我們的研發支出幾乎可以說微不足道。不過 Joe，你來說吧？

Sure. Thanks, Vish. Yes, Ram, I believe the question was just drivers of R&D spend for 2026 and going forward. As you may recall, we have to do the registry study that was part of the FDA approval so that they the registry study costs go into R&D and then also the pipeline development costs will go into R&D.

好的。謝謝你，Vish。是的，Ram，我理解你的問題是 2026 年以及往後研發支出的驅動因素。如你所記得的，我們必須進行登錄研究（registry study），這是 FDA 核准的一部分，因此登錄研究的成本會計入研發，另外管線開發成本也會計入研發。

And again, as I mentioned on the prepared remarks, there's a shift from R&D to SG&A just with the evolution of transitioning to a commercial company. But those two items that I mentioned are going to be the main drivers of R&D spend for 2026 and outer years.

另外，如我在事先準備的發言中提到，隨著我們轉型為商業化公司，費用結構會從研發轉向銷售、一般及行政費用（SG&A）。但我提到的這兩項將會是 2026 年及更長期年度研發支出的主要驅動因素。

Sorry, go ahead, Ram.

抱歉，你繼續，Ram。

Go. No, go ahead, please.

你說。沒有，你請繼續。

I was just going to say, as you know, we do have some preclinical programs that we're not spending a lot of energy and resources on those. It's kind of running in the background. We do not see preclinical programs to stack up R&D expenses in a significant way, at least in 2026.

我只是想說，如你所知，我們確實有一些臨床前項目，但我們沒有在那些項目上投入太多精力與資源。它有點像是在背景運行。我們不認為臨床前項目會在 2026 年以顯著方式推高研發費用。

2027 is a different story. And I think a lot of it is going to depend on the ramp-up speed of ZEVASKYN and what we can bite into, right? So I think that's going to be a story that will evolve through the rest of the year.

2027 年則是另一回事。我認為很大一部分將取決於 ZEVASKYN 的放量速度，以及我們能承接多少，對吧？所以我想這會是一個在今年剩餘時間逐步演進的故事。

Just with respect to the qualified treatment centers, I was wondering if you could comment on the relative coalescing or concentration of patients around those centers. And if you expect on a go-forward basis, the bulk of new patients coming in to go through the first two treatment centers to be stood up or if you expect some of the other treatment centers to be just as significant contributors to the overall number of patients coming on to ZEVASKYN.

就合格治療中心（qualified treatment centers）而言，我想請你評論一下患者在這些中心之間相對的聚集或集中程度。以及你是否預期未來新增患者的大多數會透過最先建置的前兩個治療中心，或是你預期其他治療中心也會對 ZEVASKYN 的整體新增患者數做出同等重要的貢獻。

Yeah, that's --

是的，那是--

Go ahead, Madav.

你先說，Madav。

Yeah. We expect them to have a decent pool of patients similar to the currently stood up centers. And our strategy right now, just to expand on your question, is very clear. It's a three-pronged approach that we are taking. One is to have patients that are in these qualified treatment centers. We want to place them on ZEVASKYN therapy as soon as possible.

好的。我們預期它們會有一個相當規模的患者池，與目前已建置的中心類似。而我們目前的策略——也就是針對你問題的延伸——非常清楚。我們採取三管齊下的方法。第一是讓已在這些合格治療中心的患者，我們希望盡快讓他們接受 ZEVASKYN 治療。

The second is to focus on the community physicians who already have indicated they have patients that are motivated and would be eligible for ZEVASKYN treatment. We want those referrals to be the second tranche. And in parallel, as we look to stand up these additional centers, that is going to pancake on top of the first two-pronged approach to have their own pool of patients.

第二是聚焦於社區醫師；他們已表示手上有意願高、且符合 ZEVASKYN 治療資格的患者。我們希望這些轉介成為第二批（tranche）。同時，隨著我們建置這些新增中心，這將在前述雙管齊下策略之上再疊加，讓新增中心也能擁有其自身的患者池。

Our approach is to make sure that these centers are as geographically spread as possible because that also obviously will help with the travel, et cetera, for the patients and their families, let alone the payer barriers that we will be easier to overcome once you have more centers that are geographically spread.

我們的方法是確保這些中心在地理分布上盡可能分散，因為這顯然也能幫助患者及其家屬在旅行等方面的負擔；更不用說，一旦有更多地理分散的中心，我們也更容易克服付款方障礙。

So we do anticipate some of these centers who have the infrastructure, who have the EB centers of excellence, et cetera, to bring their own set of patients as they get activated.

因此，我們確實預期其中一些具備基礎設施、擁有 EB 卓越中心等條件的中心，在啟動後會帶來其自身的一批患者。

Maury Raycroft, Jefferies.

Maury Raycroft，Jefferies。

Congrats on the progress. I had a question on the QTCs as well. So it sounds like currently, the QTCs are able to manage about one or two patients per month. Just wanted to clarify that. And what do you expect the cruise control state to look like?

恭喜進展。我也有一個關於 QTC 的問題。所以聽起來目前 QTC 每月大約能管理一到兩位患者。我想確認一下這點。另外，你們預期所謂「定速巡航」狀態會是什麼樣子？

I guess, how many patients per QTC do you think you're going to be able to get at a sort of a maximum capacity at these initial sites? And I'll start with that one.

我想問的是，在這些初期站點，在接近最大產能的情況下，您認為每個 QTC 每月大概能收治多少位病患？我先從這個問題開始。

Go ahead, Madhav.

請說，Madhav。

That's correct, Maury. One or two patients a month. We think that their ability to ramp up, it's really dependent on the sites. Certain institutions have done their pro formas to be able to have a greater number, even go up to three patients a month, which will really depend on what their experience has been like with regard to their resource allocation and the nursing staff that have to care for the patient post operating procedures.

沒錯，Maury。每月一到兩位病患。我們認為他們提升量能的能力，確實取決於各個站點。某些機構已經做了他們的預估模型（pro forma），能夠承接更多人數，甚至可達每月三位病患；這將非常取決於他們在資源配置方面的經驗，以及術後需要照護病患的護理人力配置。

But for the most part, we expect one or two patients a month in the foreseeable future. We'll have to see how that ramps up as the experience -- what their overall process experience looks like. But even with five centers, one or two patients a month, we are looking at a really good rate.

但就大多數情況而言，在可預見的未來，我們預期每月一到兩位病患。我們還得觀察隨著經驗累積，量能會如何爬升——也就是他們整體流程經驗會呈現什麼樣貌。不過即使只有五個中心、每月一到兩位病患，我們看到的也是非常不錯的速度。

Okay. And can you also just comment on the current time line from receipt of start form to treatment initiation? Just what does that time line look like? And then could that become more efficient over time as well?

好的。另外也請您評論一下，目前從收到 start form 到開始治療的時間軸是多久？這個時間軸大概長什麼樣子？以及隨著時間推進，這個流程是否也能變得更有效率？

Right. The current time lines are very variable. It depends on various factors. But if I were to just kind of average ballpark, it's more like four- to five-month process, of which 25 days is manufacturing time. That's very much a hard fix there.

是的。目前的時間軸差異很大。取決於多種因素。但如果我用平均的概略估計，大概是四到五個月的流程，其中 25 天是製造時間。這部分基本上是硬性固定的。

So four to five months, that includes one month, roughly one month of manufacturing. And we expect that to improve over time.

所以四到五個月，其中包含大約一個月左右的製造時間。我們預期這會隨著時間而改善。

Yeah, I'm glad you asked this question, Maury, because another factor here is you mentioned start form. I would say from the point of identifying a patient to when they receive treatment because the start form is something that we are seeing has a lot of variation in when a site that form to us. Some sites do it soon after an identified patient has either referred or they have had a consult and some sites wait until the entire payer process takes place and then put a start form.

是的，我很高興你問這個問題，Maury，因為這裡還有另一個因素：你提到 start form。我會說應該從「辨識出病患」到「病患接受治療」這個時間點來看，因為我們看到各站點把那份表單交給我們的時間差異很大。有些站點在病患被轉介或完成門診諮詢後不久就會提交；有些站點則會等到整個付款方（payer）流程完成後才提交 start form。

So it's a very variable input as to what point in the patient's journey we receive that. So I think it adds one more layer of confounding variables to calculate that time.

因此，我們在病患旅程的哪個時間點收到表單，本身就是非常不一致的輸入。所以我認為這又增加了一層混雜變數，使得計算那個時間變得更困難。

But what Madhav is describing here as this approximate five months is when there is a consult that happens and patient intends to get ZEVASKYN and that conversation has happened, then the first few patients took about five months all the way to get to the treatment, whereas we are seeing that process is going to shorten over time because the administrative part of this is getting more efficient as a given site has been through two or three patients.

但 Madhav 這裡描述的約五個月，是指當諮詢已經發生、且病患打算接受 ZEVASKYN、也已經完成那段溝通之後，最初幾位病患從頭到尾到實際治療大約花了五個月；而我們也看到這個流程會隨時間縮短，因為當某個站點已經處理過兩到三位病患後，行政作業會變得更有效率。

I hope that makes sense.

希望這樣說得通。

Yes, that makes sense, and that's helpful. Maybe last quick question, and then I'll hop back in the queue. Just if you can comment on -- based on the demand ramp that you're seeing, how confident are you in achieving profitability first half this year?

是的，說得通，也很有幫助。也許最後一個快問，然後我就回到排隊。就您目前看到的需求爬升情況，您對於今年上半年達成獲利有多大信心？

We believe that we have a pretty good chance of achieving profitability. I think profitability, if you define it as an entire company level profitability, I think there's numerous factors, as you already know, we've mentioned that anything north of three patients a month takes us to the profitable zone, which is $100 million, give or take, is about the company burn in a given year, right?

我們相信達成獲利的機會相當大。我想如果把獲利定義為整個公司層級的獲利，會有許多因素；如你所知，我們也提過，每月超過三位病患就能讓我們進入獲利區間；以一年來看，公司現金消耗（burn）大約是 1 億美元上下，對吧？

So if you use your gross to net calculations, 3.5 or more per month is taking us to the profitable zone. I think this is a very achievable target. It's more -- there are some uncertain factors as to how the third and the fourth sites are going to achieve their speed and reach the cruise control and also how quickly we're bringing additional sites even on board and up and running.

所以如果用你的 gross-to-net 計算，每月 3.5 位或以上就能把我們帶到獲利區間。我認為這是非常可達成的目標。更大的不確定性在於第三與第四個站點能以多快的速度達到穩定運轉（cruise control），以及我們能多快把更多站點納入並啟動營運。

So I think these are a couple of variables, but we feel this is a pretty reasonable goal.

所以我認為這是幾個變數，但我們覺得這是一個相當合理的目標。

Stephen Willey, Stifel.

Stephen Willey，Stifel。

On the progress. Has the target number of QTCs that you want to bring online over the longer term, has that increased at all? I know you have some early experience on the referral front. I'm just curious if you're finding that it might be logistically easier to activate more of these centers as opposed to trying to increase the band of referrals.

關於進展。你們希望在較長期內上線的 QTC 目標數量，有沒有增加？我知道你們在轉介方面已經有一些早期經驗。我只是好奇，你們是否發現，相較於試圖提高轉介量，啟動更多這類中心在物流上可能更容易？

Go ahead, Mike.

請說，Mike。

Right. Our target QTC number, Steve, has been five to seven, and we do think that seven this year is a realistic goal. That does help with certainly the bandwidth within the qualified treatment centers as well as just increasing the footprint overall. We think we'll have more outlets for patients to get treated. So we're going to be working towards bringing these centers on board.

好的。Steve，我們的 QTC 目標數一直是五到七個，而且我們確實認為今年達到七個是現實的目標。這當然有助於合格治療中心內部的承載量（bandwidth），也能擴大整體覆蓋範圍。我們認為病患會有更多管道可以接受治療。所以我們會持續推進讓這些中心加入。

But in the meantime, also, of course, as the various community physicians have patients, we want that healthy awareness and healthy enthusiasm from all of the other physicians also so that in the longer term, that's really where we will rely on these community physicians to funnel their patients into the qualified centers.

但同時，當然，隨著各社區醫師手上有病患，我們也希望所有其他醫師都能有健康的認知與正向的熱度；因為從長期來看，我們確實會依賴這些社區醫師把病患導入合格中心。

So that's really our approach. So our target centers right now is seven. And as I said, we have more centers that are working with us and would like to be activated. So if we have more treatment centers, then certainly that only adds more to the process and even the logistics.

這就是我們的做法。所以我們目前的目標中心數是七個。如我所說，還有更多中心正在與我們合作並希望被啟動。因此，如果我們有更多治療中心，當然只會讓流程與物流面更有助益。

Go ahead.

請說。

Just one clarification is also, as Madhav explained, the QTC onboarding process itself can take several months. So while we talked about five additional centers beyond the four that we're working -- which are already activated, gives you a bigger number. We anticipate that some of those may spill over to even next year, right, because it's a lengthy process. But we are definitely looking to have seven activated sites this year.

再補充一點釐清：如 Madhav 所解釋，QTC 的導入（onboarding）流程本身可能需要好幾個月。所以雖然我們談到在目前已在合作、且已啟動的四個中心之外，再增加五個中心——這會讓數字更大。我們預期其中一些可能會延續到明年，對吧，因為這是一個漫長的流程。但我們確實希望今年能有七個站點完成啟動。

Okay. So when you say you're actively onboarding five additional centers, that does not include the two that have recently signed up, Colorado Children's and UTMB.

好的。所以當你說你們正在積極導入另外五個中心時，這不包含最近剛加入的兩個——Colorado Children's 和 UTMB。

Correct.

正確。

Understood. And then is there just anything you can talk about on the reimbursement side, specifically as it pertains to preauthorization just curious if payers are kind of pegging themselves to inclusion/exclusion criteria from the Phase 3? Is it pegged to the label? Just any color there would be helpful.

了解。另外，在給付（reimbursement）方面，特別是事前授權（preauthorization），你們是否能談談？我好奇付款方是否會把自己對齊到第三期試驗的納入／排除標準。還是會對齊到標籤（label）？任何補充說明都會很有幫助。

Yeah. We are seeing a mix definitely to inclusion/exclusion criteria given the high-cost nature of the product. They want to make sure that their initial set of patients are guided to the inclusion/exclusion. But then we also have major plan like UnitedHealthcare and many of the Medicaid states also looking to have coverage that are favorable to the label criteria. So it really depends on the plans.

是的。鑑於該產品的高成本特性，我們確實看到在納入/排除標準上出現不同的組合。他們希望確保最初那一批患者能依照納入/排除標準來引導。但同時，我們也看到像 UnitedHealthcare 這樣的大型保險計畫，以及許多 Medicaid 州，也在考慮提供更符合標籤適應症標準的給付。所以這真的取決於各個保險計畫。

But regardless of the criteria, what we are seeing is with letters of medical necessities, physicians have been able to overturn sort of the requirements. So for instance, if there is an age, age is one major aspect that you're seeing in the sense six years and above was our inclusion criteria. But for patients that are less than six, physicians have been able to overturn that.

但不論標準如何，我們看到的是，透過醫療必要性函（letters of medical necessities），醫師已能夠在某種程度上推翻這些要求。例如，如果有年齡限制，年齡是你們看到的一個主要面向，因為我們的納入標準是六歲以上。但對於未滿六歲的患者，醫師已能夠推翻該限制。

Also with regard to squamous cell carcinoma and their presence in the body location, that is also one other factor that physicians have been able to overturn and get the patients onto the product. So as more patients go through the process in terms of the overall timing, that's also improving because letters of medical necessities and the templates that are required, those templates are getting populated, right?

另外，關於鱗狀細胞癌以及其在身體部位的存在，這也是醫師能夠推翻的另一個因素，並讓患者使用該產品。因此，隨著更多患者走完整個流程，在整體時程方面也在改善，因為醫療必要性函以及所需的範本正在被填寫完善，對吧？

So for future and subsequent patients, for processes that are unique to ZEVASKYN, we are seeing that time also to improving at the QTCs that are already treating patients. So that's really the reimbursement process.

因此，對於未來及後續患者，針對 ZEVASKYN 特有的流程，我們也看到在已經治療患者的 QTC，那段時間也在改善。這就是整個給付/報銷流程。

The bottom line, though, is that these inclusion/exclusion criteria do not prevent a patient from getting reimbursed eventually with all these additional steps that we're taking. So even if the plan has that kind of restriction, we're able to work through that and get patients reimbursed.

不過，重點是，透過我們正在採取的這些額外步驟，這些納入/排除標準並不會阻止患者最終獲得報銷。所以即使保險計畫有那類限制，我們也能夠加以處理並讓患者獲得報銷。

Okay. And then just lastly, I think you mentioned that there's, I believe, another 10 patients or so that are targeting biopsies for next quarter. Can you just speak to how those patients are distributed against the two QTCs that are already treating patients versus Colorado and UTMB that you'll be activating here shortly?

好的。最後，我想你提到，應該還有大約另外 10 位患者，目標是在下個季度進行活檢。你能否談談這些患者在已經治療患者的兩個 QTC，與你們即將啟用的科羅拉多以及 UTMB 之間的分布情況？

It's across all of the four QTCs.

分布在全部四個 QTC。

Kristen Kluska, Cantor Fitzgerald.

Kristen Kluska，Cantor Fitzgerald。

I wanted to ask about the dialogue or the relationship between the QTCs themselves. It sounds like Stanford and Chicago being the first two are kind of paving the way here, having a little bit of additional time to get things on board. Are they working with the additional two QTCs just to kind of be a sounding board help as everybody familiarizes themselves with this process?

我想問的是 QTC 彼此之間的對話或關係。聽起來史丹佛和芝加哥作為最先的兩個中心，算是在這裡鋪路，因為他們有多一點時間把事情導入到位。他們是否有與另外兩個 QTC 合作，作為一個意見交流的對象，協助大家熟悉這個流程？

They -- not that we are directly aware of. We certainly -- it's a tight physician community. So they do talk to each other in terms of the sharing of the best practice as well as administrative steps. Plus our teams are also actively working with them in helping them cross-pollinate the best practices.

他們——就我們直接所知並沒有。我們當然——這是一個緊密的醫師社群。所以他們確實會彼此交流，分享最佳實務以及行政步驟。此外，我們的團隊也在積極與他們合作，協助把最佳實務相互移植與擴散。

Okay. And then just as we think about the fact that some additional biopsies are already scheduled and we have two weeks left in 1Q, should we be conservatively modeling that these are more likely to come in 2Q versus the current quarter?

好的。另外，考量到一些額外的活檢已經排程，而第一季只剩兩週，我們是否應該保守地建模，認為這些更可能在第二季入帳，而不是在本季？

We expect one -- yes, no, for this month, Christine. But of course, until the biopsy is done, it's not -- we don't know. We don't see a reason why there should be any attrition or a drop off, but it is for this month that we expect additional biopsy.

我們預期有一例——是的，不，會在這個月，Christine。但當然，在活檢完成之前，這並不是——我們也不知道。我們看不出有任何理由會出現流失或中途退出，但我們預期本月會有額外的活檢。

Okay. And then it sounds like we'll get one more QTC pretty quickly and another two maybe before the end of the year. How are you thinking just about dispersing throughout the geography in the country? And how has that played an impact so far about getting patients on board, ability to travel to these sites, et cetera?

好的。另外，聽起來我們會很快再新增一個 QTC，而另外兩個可能在年底前。你們如何思考在全國地理上的分布？到目前為止，這對於讓患者加入、前往這些中心的旅行能力等等，產生了什麼影響？

We -- our goal is to have a geographically dispersed. I mean, clearly, you can see that Eastern Seaboard is an important area for us. So if we have a center in that region, I think that will certainly help with patient access. And these patients for other reasons with their other comorbidities, they do have travel. They do travel significant distances to get therapies.

我們——我們的目標是做地理上分散的布局。我的意思是，很明顯你可以看到，美國東岸對我們而言是重要區域。所以如果我們在那個地區有一個中心，我認為這肯定會有助於患者可近性。而這些患者因為其他原因、伴隨其他共病，他們確實需要旅行。他們會長距離旅行來接受治療。

So we don't really think that even five or seven is going to be -- is going to impede their ability to travel really for ZEVASKYN. But of course, as more centers come on board, that's definitely going to be a positive thing.

所以我們不太認為，即使只有五個或七個中心——會——會妨礙他們為了 ZEVASKYN 旅行的能力。但當然，隨著更多中心加入，這肯定會是正面的。

And also the flexibility that it offers right now, certain patients, I'm not saying this is true for every patient, some patients crossing state borders have extra paperwork to go through Medicaid, right? There's more bureaucratic steps. Those things will also be streamlined a little bit by offering more choice and flexibility on where they can get treated. So that's really what we are also excited about.

另外，目前它所提供的彈性是，某些患者——我不是說每位患者都如此——有些患者跨州時，透過 Medicaid 需要額外的文件流程，對吧？會有更多官僚程序。透過提供更多選擇與彈性，讓他們可以在更多地點接受治療，這些事情也會稍微被簡化。所以這也是我們感到興奮的地方。

Jeff Jones, Oppenheimer.

Jeff Jones，Oppenheimer。

Maybe the first one on manufacturing. How comfortable are you at this point that the sterility testing is well behind you now? And just a reminder, if you would, on current production capacity and the expansion plan of that capacity through the year.

第一個可能是關於製造。到目前為止，你們對無菌測試已經完全成為過去式有多有信心？另外也請你提醒一下，目前的產能，以及今年內擴充產能的計畫。

And then the second one, maybe on patient and physician feedback now that you've treated patients out in the commercial setting. What is the feedback you've been getting from physicians and patients on the overall experience?

第二個可能是關於患者與醫師的回饋，現在你們已在商業環境中治療了患者。你們從醫師與患者那裡收到的整體體驗回饋是什麼？

Thank you, Jeff. So your first question is about manufacturing the sterility test. Is that behind us and how we're ramping up capacity. We do have our CTO, Dr. Brian Kevany on the call. Brian, can you take that one, please?

謝謝你，Jeff。所以你的第一個問題是關於製造端的無菌測試。是否已經解決，以及我們如何提升產能。我們的 CTO Brian Kevany 博士也在線上。Brian，你可以回答這題嗎？

Yeah. As a reminder, we had a very healthy dialogue with the agency around the sterility assay issue. And that was a very productive conversation with the agency, and we do feel very confident that the resolution that came out of that is a solution going forward. We'll continue to always look to ways to improve our manufacturing and testing process, but we do feel very confident that the resolution that came out of those discussions is going to support us going forward.

可以。提醒一下，我們就無菌檢測（sterility assay）議題與主管機關進行了非常良好的溝通。那次與主管機關的對話非常有成效，我們也非常有信心，從中得到的解決方案將可作為未來的長期方案。我們會持續尋找改善製造與檢測流程的方法，但我們確實非常有信心，這些討論所產出的解決方案將能支持我們往前推進。

And as it relates to production capacity, currently, we're running at a cadence of 6 patients per month within the facility and continue to develop the space to be capable of reaching that 10 patient per month capacity that we have previously discussed throughout the rest of this year. And all of those activities are on track to meet that goal. And it's actually lining up very well with the onboarding the additional QTCs to maintain a steady level of supply for those sites as they come on board.

至於產能方面，目前我們在該設施的生產節奏是每月 6 位患者，並持續開發空間，以在今年其餘時間達到我們先前討論過的每月 10 位患者產能。而所有這些活動都按計畫進行，以達成該目標。而且這也與新增 QTC 的導入節奏非常吻合，能在各中心加入時維持穩定的供應水準。

Yeah. And I just wanted to also add on the sterility thing, right, Jeff, which is we've done a lot of work trying to minimize the probability that, that problem occurs again. Whether we can go, say, 40 runs or 50 runs and never saw this problem happen again, that's only going to be empirically proven. But all our feasibility studies point out that the probability is significantly reduced by at least a log order or more. So that's what gives us the strength, but we're not stopping at that.

是的。我也想補充一下無菌性這件事，對吧，Jeff，我們已經做了大量工作，試圖把這個問題再次發生的機率降到最低。至於我們是否能做到例如連續40次或50次生產批次都不再看到這個問題發生，這只能透過經驗來證明。但我們所有的可行性研究都指出，發生機率已顯著降低，至少降低了一個對數級或更多。所以這就是我們的底氣所在，但我們不會止步於此。

Whatever we've implemented as an improvement to reduce those false positives, we're not stopping at that. We're also doing the next-generation rapid sterility development alongside this so that we can get to an even better level. So this is part of -- when you say R&D, we're always thinking about pipeline. There's a lot of life cycle management R&D that goes into optimizing ZEVASKYN. That's really where some of our teams and the quality function are focused on.

無論我們已經實施了哪些改進來降低那些偽陽性，我們都不會止步於此。我們也在同步推進下一代快速無菌檢測的開發，讓我們能達到更好的水準。所以這也是——當你說到研發（R&D）時，我們一直在思考產品管線。有大量的生命週期管理研發投入在優化ZEVASKYN上。這正是我們部分團隊以及品質職能所聚焦的地方。

And as Brian said, we're already operating at six manufacturing runs a month cadence. So this is -- right now, with the current demand, it's keeping up, and that's going to be ramped up to about 10 a month by second half of the year. So that's also coming.

而且如Brian所說，我們目前已經以每月六次製造批次的節奏在運作。所以——以目前的需求來看，現在是跟得上的，而且今年下半年會把產能提升到每月大約10次。所以這也正在推進中。

The second question that you asked was about the patient and HCP feedback on the current treatment. I'll just preface this by saying that there's only two patients that have been treated and there's not enough time that has passed along because if you remember, even our endpoints and assessments and things like that happen in six months. This is a therapy with a durability play, right? So I don't know if we have enough feedback, but I'll just open it up to Madhav to see what he has on that.

你問的第二個問題是關於病患以及醫療照護專業人員（HCP）對目前治療的回饋。我先說明一下，目前只有兩位病患接受治療，而且時間也還不夠長；因為如果你記得，我們的終點指標、評估等都是在六個月時進行。這是一種主打持久性的療法，對吧？所以我不確定我們是否有足夠的回饋，但我先把問題交給Madhav，看看他對此有什麼補充。

Nothing more to add, Vish, to what you have said at this point.

目前沒有更多要補充的，Vish，就如你剛才所說。

Overall, yes, because when we talk to doctors, they say, oh, that patient is doing well. What does that really mean? I mean, does it -- are you talking about wound healing or are you talking about general health of the patient? These are things that we don't really know. So it's too premature to comment on that.

整體而言，是的，因為當我們和醫師交談時，他們會說，喔，那位病患狀況很好。但那到底代表什麼？我的意思是——你是在說傷口癒合，還是在說病患的整體健康狀況？這些其實我們並不清楚。所以現在評論還太早。

David Bautz, Zacks Small Cap Research.

David Bautz，Zacks Small Cap Research。

So I got a couple of questions about the patients that you've already treated. First off, are you aware if they were also simultaneously being treated with VYJUVEK, say, maybe for their smaller wounds if they had any. Do you anticipate the need to retreat either of those patients later in 2026? And then are you aware if there are any exclusions for retreatment, say, if any of the payers have restrictions on the ability to get retreated?

我有幾個關於你們已經治療過的病患的問題。首先，你們是否知道他們是否也同時使用VYJUVEK治療，例如如果他們有較小的傷口的話。你們是否預期在2026年稍晚需要對其中任何一位病患進行再次治療？另外，你們是否知道在再次治療方面是否有任何排除條件，例如某些付款方是否對再次治療的可行性有所限制？

Go ahead, Madhav.

Madhav，你來回答。

Yes. So we don't know the VYJUVEK related question. What we do know is that these patients were not simultaneously on VYJUVEK. That's the information we have. But with regard to their prior history of VYJUVEK, we think that most of these patients have received VYJUVEK at some point in their journey.

是。關於VYJUVEK相關的問題，我們不清楚。我們知道的是，這些病患並沒有同時使用VYJUVEK。這是我們掌握的資訊。但就他們過去使用VYJUVEK的病史而言，我們認為這些病患中的大多數在其治療歷程中的某個階段都曾接受過VYJUVEK。

Your second question with regard to retreatment -- based on the physician feedback, these patients have significantly large wound areas and that they have said that, yes, these patients would require a second round of ZEVASKYN treatment.

你第二個關於再次治療的問題——根據醫師回饋，這些病患的傷口面積非常大，他們表示，是的，這些病患將需要第二輪的ZEVASKYN治療。

We don't know if that is going to be this year or if this is going to be next year or some other point, because these initial set of patients and to the foreseeable future, these patients have large areas of their body that require several areas to be treated.

我們不知道會是在今年、明年或其他時間點，因為這一批最初的病患，以及在可預見的未來，這些病患身體有很大範圍需要在多個部位進行治療。

The third one with regard to exclusion, no, we don't see exclusion criteria with regard to a retreatment of a patient, which is really something we are very pleased to see that payers are not blocking like ZEVASKYN for once in their lifetime. So that is encouraging.

第三個關於排除條件的問題，不，我們沒有看到針對病患再次治療的排除標準；我們很高興看到付款方並沒有把ZEVASKYN限制為一生只能用一次。所以這是令人鼓舞的。

If we do have a patient that requires a retreatment of a previously treated ZEVASKYN area, then it really depends on what the payer policies there would look like, but we are not seeing any kind of a blockade or anything of that sort based on the policies that have been published.

如果確實有病患需要對先前已治療過的ZEVASKYN部位進行再次治療，那就真的要看付款方的政策會是什麼樣子；但就已公布的政策來看，我們沒有看到任何形式的阻擋或類似情況。

Well, we have now reached the end of our question-and-answer session. I will now turn the call back over to Vish for his closing remarks.

好的，我們現在已到達問答環節的結束。我現在把電話交回給Vish，請他做結語。

Thank you, Jenny, and thank you, everyone, for joining us today for the earnings call. We'll talk to you again soon.

謝謝你，Jenny，也謝謝各位今天參加我們的財報電話會議。我們很快再與各位交流。

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。