Elutia Inc (ELUT) 2026 Q1 法說會逐字稿

Thank you for standing by and welcome to Elutia's first-quarter 2026 earnings conference call. (Operator Instructions) I would now like to hand the call over to Bernadine Cherniak. Please go ahead.

感謝各位稍候，歡迎參加 Elutia 2026 年第一季財報電話會議。（接線員指示）現在我想把電話交給 Bernadine Cherniak。請開始。

Thank you, operator, and thank you all for participating in today's call. Earlier today, Elutia released financial results for the first quarter ended March 31, 2026. A copy of the press release is available on the company's website.

謝謝您，接線員，也感謝各位參與今天的電話會議。今天稍早，Elutia 公布了截至 2026 年 3 月 31 日止第一季的財務結果。新聞稿副本可於公司網站取得。

Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the Federal Securities laws, which are pursuant to the Safe Harbor provision of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that do not relate to matters of historical facts or relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements include without limitation, those relating to our operating trends and future financial performance are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

在開始之前，我想提醒各位，管理層在本次電話會議中將發表的部分內容，可能構成聯邦證券法所定義的前瞻性陳述，並受 1995 年《私人證券訴訟改革法》安全港條款之規範。本次電話會議中任何不涉及歷史事實，或涉及對未來事件、結果或績效之預期或預測的陳述，均屬前瞻性陳述。所有前瞻性陳述（包括但不限於與我們的營運趨勢及未來財務表現相關者）均係基於我們目前的估計及各項假設。這些陳述涉及重大風險與不確定性，可能導致實際結果或事件與這些前瞻性陳述所預期或暗示者存在重大差異。

Accordingly, you should not place undue reliance on these statements. For a list and descriptions of the risks and uncertainties associated with our business, please refer to the risk factors section of our public filings with the SEC, including Elutia's annual report on Form 10-K for the year ended December 31, 2025, and on our subsequent periodic reports on Form 10-Q and 10-K accessible on the SEC's website at www.sec.gov. Such factors may be updated from time to time in Elutia's other filings with the SEC.

因此，您不應過度依賴這些陳述。關於與我們業務相關之風險與不確定性的清單及說明，請參閱我們向美國證券交易委員會（SEC）提交之公開文件中的風險因素章節，包括 Elutia 截至 2025 年 12 月 31 日止年度的 Form 10-K 年報，以及其後定期提交的 Form 10-Q 與 10-K 報告；上述文件可於 SEC 網站 www.sec.gov 查閱。相關因素可能會不時在 Elutia 向 SEC 提交的其他文件中更新。

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 14, 2026. Elutia disclaims any intention or obligation, except those as required by law, to update or revise any financial projections or forward-looking statements because of new information, future events, or otherwise. Also during this presentation, we refer to gross margin excluding intangible assets and amortization, which is a non-GAAP financial measure. A reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure is available on the company's financial results released for the first quarter end in March 31, 2026. This is accessible on the SEC's website and posted on the investors page of the Elutia website at www.elutia.com.

本次財報電話會議包含具時效性的資訊，且僅以今日（2026 年 5 月 14 日）直播時點為準。除法律要求外，Elutia 不承擔亦無意因新資訊、未來事件或其他原因更新或修訂任何財務預測或前瞻性陳述之義務。此外，在本次簡報中，我們提及「不含無形資產及攤銷的毛利率」，此為一項非 GAAP 財務衡量指標。該非 GAAP 財務衡量指標與最直接可比之 GAAP 財務衡量指標的調節表，已載於公司公布之截至 2026 年 3 月 31 日止第一季財務結果中，可於 SEC 網站查閱，亦已張貼於 Elutia 網站 www.elutia.com 的投資人頁面。

And with that, I will turn over the call to Elutia's CEO, Randy Mills.

接下來，我將把電話交給 Elutia 的執行長 Randy Mills。

Thank you, Bernadine, and thank you, everyone, for joining us today. The first quarter of 2026 was an important quarter for Elutia. We continued to sharpen our strategic focus. We advanced our NXT-41 regulatory program. We brought our automated manufacturing platform online and we further strengthened our confidence in the commercial opportunity ahead of us in breast reconstruction.

謝謝你，Bernadine，也謝謝各位今天加入我們。2026 年第一季對 Elutia 而言是重要的一季。我們持續聚焦並精煉策略重點。我們推進了 NXT-41 的法規計畫。我們讓自動化製造平台上線，並進一步強化我們對乳房重建領域未來商業機會的信心。

Here's how we'll spend our time today. I'll walk you through the headlines of the quarter and where we're headed. Matt will take you through the financials and close with a few thoughts on what's ahead. Then we'll open the line up for questions.

今天我們將這樣安排時間。我會帶各位回顧本季重點以及我們的前進方向。Matt 會帶各位檢視財務表現，並以對未來的幾點看法作結。之後我們將開放提問。

Today, Elutia is increasingly becoming a pure play, drug-eluting biometrix company focused on one of the largest and most underserved opportunities in reconstructive surgery. Four things I would like to highlight from the quarter.

如今，Elutia 正日益成為一家純粹的藥物釋放型生物基質公司，聚焦於重建外科中規模最大且服務最不足的機會之一。本季我想強調四點。

First, our FDA review of NXT-41 is progressing through productive interactions with the agency, and the dialogue has increased our confidence in the planned NXT-41x submission. We continue to anticipate NXT-41x clearance in the fourth quarter of 2026 and NXT-41x clearance in the first half of 2027.

第一，我們的 NXT-41 FDA 審查正透過與主管機關的有效互動而持續推進，相關對話也提升了我們對既定 NXT-41x 送件計畫的信心。我們仍預期 NXT-41x 將於 2026 年第四季取得核准，並於 2027 年上半年取得 NXT-41x 核准。

Second, we brought our automated manufacturing platform online this quarter. That platform supports a target gross margin in excess of 80% at scale, enabling a differentiated value proposition at competitive pricing.

第二，我們在本季讓自動化製造平台上線。該平台在規模化後可支撐超過 80% 的目標毛利率，使我們能在具競爭力的定價下提供差異化的價值主張。

Third, direct surgeon engagement by our commercial team is confirming what we have believed all along, a $1.5 billion US market, post-operative infection rates of 15% to 20%, and no meaningful innovation in standard of care.

第三，我們商業團隊與外科醫師的直接互動，正在印證我們一直以來的判斷：美國市場規模為 15 億美元、術後感染率為 15% 至 20%，且標準照護並無實質創新。

And fourth, the end of the quarter with a strong balance sheet. $36.5 million in cash and escrow, and we are actively engaged in two strategic processes. The SimpliDerm divestiture we previously announced and a newly disclosed inbound acquisition interest in our Cardiovascular product line. It is increasingly clear that within the $1.5 billion breast surgery market, NXT-41x has the potential to be a blockbuster and to meaningfully improve outcomes for women with breast cancer.

第四，我們在季末維持強健的資產負債表：現金與託管款合計 3,650 萬美元，且我們正積極推進兩項策略流程：先前已宣布的 SimpliDerm 出售案，以及新近揭露、針對我們心血管產品線的外部併購意向。愈來愈清楚的是，在 15 億美元的乳房手術市場中，NXT-41x 具備成為重磅產品（blockbuster）的潛力，並可實質改善乳癌女性的治療結果。

For anyone new to the Elutia story, here is the short version of what we do. Our approach is simple but differentiated. We combine a proven biologic matrix platform with sustained local antibiotic delivery designed to prevent bacterial colonization and the cascade of complications like infection that can follow.

對於第一次接觸 Elutia 的朋友，以下是我們業務的精簡版。我們的方法簡單但具差異化：將經驗證的生物基質平台，與可在局部持續釋放抗生素的機制結合，以預防細菌定殖，以及其後可能引發的感染等一連串併發症。

Importantly, we have done this before. Our first generation drug eluting product, EluPro, was the first FDA-cleared Antibiotic-Eluting BioEnvelope. We developed it, we cleared it, we commercialized it, and last October, we sold that business to Boston Scientific for $88 million. That prior success gives us confidence not only in the technology itself, but also in our ability to develop, make, and commercialize differentiated drug-eluting products. NXT-41x takes that same validated platform into a much larger market with a much larger unmet medical need.

重要的是，我們以前就做過。我們第一代藥物釋放產品 EluPro，是第一個獲 FDA 核准的抗生素釋放型 BioEnvelope。我們完成研發、取得核准並推向商業化，而在去年 10 月，我們以 8,800 萬美元將該業務出售給波士頓科學（Boston Scientific）。先前的成功不僅讓我們對技術本身有信心，也讓我們對自身開發、製造與商業化差異化藥物釋放產品的能力更有把握。NXT-41x 將同一個已驗證的平台帶入更大的市場，對應更龐大的未滿足醫療需求。

We believe the opportunity in front of us is transformational for three reasons: one, it's a big market. A $1.5 billion in the US alone; two, it's a big problem. 15% to 20% of patients develop post-operative infection after a mastectomy. And if anything, that number's conservative; and three, we already have a proven solution. The $88 million that Boston Scientific paid for our first generation product tells you that it works.

我們認為眼前的機會具有轉型意義，原因有三：第一，市場很大——僅美國就有 15 億美元；第二，問題很大——乳房切除術後有 15% 至 20% 的病患出現術後感染，而且若有差別，這個數字可能還偏保守；第三，我們已經有經驗證的解決方案——波士頓科學為我們第一代產品支付的 8,800 萬美元，說明它確實有效。

Let me put the market into concrete numbers.

我用具體數字來說明這個市場。

Approximately, 168,000 breast reconstruction procedures last year were performed in the United States. Biologic mesh is utilized in more than 85% of those implant-based reconstructions, biologics account for roughly 65% of the total procedural spend, and human biologic mesh today sells for somewhere between $7,500 and $9,500 per breast. Put that all together, and you have a $1.5 billion US market opportunity.

去年在美國約進行了 168,000 例乳房重建手術。在這些以植入物為基礎的重建中，超過 85% 會使用生物網片；生物材料約占整體手術支出的 65%；而目前人源性生物網片每側乳房的售價約在 7,500 至 9,500 美元之間。綜合以上，即可得出美國約 15 億美元的市場機會。

This is not a market we have to create. It already exists. Biologic matrices are already deeply embedded into the standard of care. Surgeons use them in the vast majority of these procedures. Our job is simpler than building a new category. We just have to give them a better version of what they're already using.

這不是我們必須去創造的市場；它已經存在。生物基質已深度嵌入標準照護。外科醫師在絕大多數此類手術中都會使用。我們的工作比建立一個新類別更簡單：只要提供他們一個比現有使用產品更好的版本。

In breast reconstruction, the unmet need for this is severe. 1 in 3 women suffer a serious complication after reconstruction, 15% to 20% develop a post-operative infection, up to 21% experienced implant loss, and the average hospital cost of a single infection ends up being more than $48,000.

在乳房重建領域，這方面的未滿足需求非常嚴重。每 3 位女性就有 1 位在重建後遭遇嚴重併發症；15% 至 20% 會出現術後感染；高達 21% 會發生植入物喪失；而單次感染的平均住院成本最終超過 48,000 美元。

But remember why this woman is in the operating room in the first place. She was diagnosed with cancer. Her number one goal is to beat that cancer. And when infection takes hold, chemotherapy stops, radiation stops, everything stops until the infection is resolved.

但請記住，這位女性之所以進入手術室的原因。她被診斷出癌症。她的首要目標是戰勝癌症。而一旦感染發生，化療停止、放療停止，一切都會停止，直到感染被控制與解決。

This is not a minor complication. This is a cancer treatment derailing events, and the standard of care today does not solve it. NXT-41x is not a passive support mechanism. It is an active partner in recovery.

這不是小問題。這是會使癌症治療偏離軌道的事件，而現行標準照護並未解決它。NXT-41x 不是被動的支撐機制；它是復原過程中的主動夥伴。

It is easy to use. It fits the surgical workflow the surgeon already knows. It's cost-neutral to the hospital. There were places legacy products that they're already buying, and it delivers powerful, sustained, uniform antibiotic coverage right at the surgical site where a systemic antibiotics struggle to reach.

它容易使用，符合外科醫師已熟悉的手術流程；對醫院而言成本中性。它可取代他們已在採購的既有產品，並在手術部位提供強效、持續且均勻的抗生素覆蓋，而全身性抗生素往往難以有效到達該處。

Unlike legacy biologic matrix with -- that have little functional differentiation, our goal is to deliver differentiated functionality at a competitive economic profile. We believe that matters.

不同於幾乎沒有功能性差異的既有生物基質產品，我們的目標是在具競爭力的經濟條件下，提供差異化功能。我們相信這很重要。

With that backdrop, let me walk you through the work we did this quarter to advance the program. Let me first start with the FDA review. We continue to have productive interactions with the FDA regarding the NXT-41 submission. As a reminder, NXT-41 is the base biologic matrix and it serves as the foundation for NXT-41x drug-eluting version that will follow.

在上述背景下，讓我帶各位回顧我們本季為推進該計畫所完成的工作。我先從 FDA 審查談起。我們持續就 NXT-41 送件與 FDA 進行富有成效的互動。提醒各位，NXT-41 是基礎生物基質，並作為後續 NXT-41x 藥物釋放版本的基礎。

Well, we're not going to comment on every detail of the review process. What I can say is that our dialogue with FDA has increased our confidence in the plan and NXT-41x submission strategy. The discussions have helped clarify what FDA views as an important from a submission standpoint.

嗯，我們不會對審查流程的每個細節都加以評論。我能說的是，我們與 FDA 的對話提升了我們對該計畫以及 NXT-41x 送件策略的信心。這些討論有助於釐清從送件角度來看，FDA 認為哪些事項是重要的。

We continue to anticipate NXT-41x clearance in the first quarter of 2026, and expect NXT-41x clearance in the first half of 2027. The point I want you to take from this slide is our confidence has increased.

我們仍預期 NXT-41x 將於 2026 年第一季獲得核准，並預期 NXT-41x 將於 2027 年上半年獲得核准。我希望你從這張投影片帶走的重點是：我們的信心提高了。

Let me shift to manufacturing. One of the most important accomplishments this quarter was bringing our automated manufacturing platform all operationalized, the core automated production equipment intended to support NXT-41x manufacturing at scale.

接著我轉到製造面。本季最重要的成果之一，是讓我們的自動化製造平台全面投入運作，也就是用於支援 NXT-41x 規模化製造的核心自動化生產設備。

This is strategically important for several reasons. First, the robotic coating system enables precise and reproducible application of the drug eluting layer onto the biologic matrix.

這在策略上之所以重要有幾個原因。第一，機器人塗佈系統可將藥物釋放層精準且可重複地塗佈於生物基質上。

Second, the integrated in-house approach is designed to support scalability, efficiency, and quality control.

第二，整合式的內部作業模式旨在支援可擴充性、效率與品質控管。

And third, we believe this process creates a meaningful, competitive advantage. The integrated process supports a targeted gross margin of above 80% at scale and an 80% plus gross margin gives us real pricing room against incumbent products that sell for between $7,500 to over $9,500 per breast, while still delivering best in class margins. Said differently, NXT-41x is designed to compete both on outcomes and cost. That is a hard combination for an incumbent to respond to.

第三，我們相信這項流程能創造具意義的競爭優勢。該整合流程在規模化後可支援超過 80% 的目標毛利率，而 80% 以上的毛利率讓我們在定價上相較於既有產品（每側乳房售價約 7,500 美元至超過 9,500 美元）仍有實質空間，同時仍能提供同級最佳的利潤率。換句話說，NXT-41x 的設計目標是在療效與成本上同時競爭。這種組合讓既有業者很難回應。

Now, let me turn to commercialization, which I'm particularly excited about. Our commercial readiness work continues to increase our confidence in the market opportunity. Since joining Elutia, our Chief Commercial Officer, Pete Ligotti, has spent a substantial amount of time in the field speaking directly with surgeons and hospital stakeholders, and the feedback has been remarkably consistent.

現在我來談商業化，這部分我特別興奮。我們的商業化就緒工作持續提升我們對市場機會的信心。自加入 Elutia 以來，我們的首席商務長 Pete Ligotti 花了大量時間在第一線，直接與外科醫師及醫院利害關係人交流，而回饋出奇地一致。

The clinical need is real and it is significant. Surgeons describe postoperative infection in downstream complications as one of the most frustrating challenges they face in breast reconstruction; second, there remains a clear lack of meaningful innovation anywhere within this category; and third, the commercial opportunity appears to be highly concentrated. Look at this funnel.

臨床需求是真實且顯著的。外科醫師形容術後感染及其後續併發症，是乳房重建中他們面臨最令人挫折的挑戰之一；第二，在此類別中仍明顯缺乏具意義的創新；第三，商業機會似乎高度集中。請看這個漏斗圖。

As we discussed, the US breast reconstruction market is $1.5 billion, and there are about 168,000 procedures performed last year. About 1,800 US hospitals perform reconstruction, but only 585 of those hospitals account for three quarters of the entire market and the Top 50 centers alone represent over $300 million in spends.

如我們所討論，美國乳房重建市場規模為 15 億美元，去年約進行 168,000 例手術。美國約有 1,800 家醫院進行重建手術，但其中僅 585 家醫院就占了整體市場的四分之三，而前 50 大中心單獨就代表超過 3 億美元的支出。

Here's the insight. This is a billion dollar plus US market, but the real volume is concentrated at a few 100 hospitals. This is not a market that requires thousands of accounts or a massive sales infrastructure to establish meaningful penetration. We believe targeted engagement with high volume centers can create substantial leverage, and that is exactly the team Pete is putting together.

這裡的洞見是：這是美國超過 10 億美元的市場，但真正的量集中在數百家醫院。這不是一個需要數千個客戶或龐大銷售基礎設施才能建立有意義滲透率的市場。我們相信，針對高量中心的精準互動可以創造可觀的槓桿效益，而這正是 Pete 正在組建的團隊所要做的。

Before Matt walks you through the financials, let me briefly address our strategic process. As we have previously discussed, we continue to evaluate opportunities to further focus the company around NXT-41x and its platform.

在 Matt 帶各位看財務數字之前，我先簡要說明我們的策略流程。如先前所述，我們持續評估進一步聚焦公司於 NXT-41x 及其平台的機會。

With SimpliDerm, interest is strong and the process is going well. SimpliDerm is a high-quality business, $2.1 million in revenue in this quarter at a 57% gross margin. We have strong reimbursement coverage with approximately 100 million covered lives across United Healthcare, Anthem, and nine regional plans, and it has a differentiated patent-protected manufacturing process.

就 SimpliDerm 而言，市場興趣強勁，流程進展順利。SimpliDerm 是一項高品質業務，本季營收 210 萬美元、毛利率 57%。我們擁有強勁的給付覆蓋，涵蓋 United Healthcare、Anthem 以及九個區域性方案，合計約 1 億名受保人，且其製造流程具差異化並受專利保護。

But separately, we have received inbound acquisition interest in our related Cardiovascular product line. For context, that business did a million dollars in revenue this quarter at an 85% gross margin that's up from $300,000 just a year ago. These are strong products with differentiated clinical profiles and tractive gross margins.

另外，我們也收到與我們相關的心血管產品線之主動併購意向。作為背景，該業務本季營收 100 萬美元、毛利率 85%，較一年前的 30 萬美元大幅成長。這些都是具差異化臨床特性且毛利率具吸引力的強勢產品。

However, as we evaluate the company strategically, our priority is ensuring that capital, resources, and management attention are aligned with the largest long-term opportunity for value creation, which is NXT-41x. So we are going to provide further updates on both processes as appropriate.

然而，當我們從策略面評估公司時，我們的優先事項是確保資本、資源與管理層注意力，能與長期價值創造的最大機會一致，也就是 NXT-41x。因此，我們將在適當時機就兩項流程提供進一步更新。

Now with that I'd like to turn the call over to Matt.

接下來，我想把電話會議交給 Matt。

Okay. Thanks, Randy. I'll begin with a review of our first quarter financial results from continuing operations, which exclude the divested BioEnvelope business that we sold to Boston Scientific in October of last year. Total net sales for the first quarter were $3.1 million compared to $3.0 million in the prior year period. Growth of approximately 6% year over year.

好的，謝謝你，Randy。我先回顧我們第一季持續營運的財務結果，該結果不包含我們去年 10 月出售給 Boston Scientific 的已剝離 BioEnvelope 業務。第一季總淨銷售額為 310 萬美元，較去年同期的 300 萬美元增加，年增約 6%。

SimpliDerm revenue is $2.1 million compared to $2.6 million a year ago. Cardiovascular revenue was $1.0 million compared to $300,000 in the prior year period. The increase in Cardiovascular was primarily driven by a return to direct distribution, but also to improved procedural volume.

SimpliDerm 營收為 210 萬美元，較一年前的 260 萬美元下降。心血管營收為 100 萬美元，較去年同期的 30 萬美元增加。心血管業務的成長主要來自恢復直營通路分銷，同時也受惠於手術量提升。

Turning to profitability. GAAP gross margin for the quarter was 58% compared to 47% in the prior year period. Adjusted gross margin, which excludes amortization of acquired and tangible assets, was 67% compared to 56%. The year over year improvement reflects favorable product mix and price improvements.

接著看獲利能力。本季 GAAP 毛利率為 58%，去年同期為 47%。調整後毛利率（排除併購取得之無形與有形資產攤銷）為 67%，去年同期為 56%。年對年改善反映了有利的產品組合與價格提升。

Total operating expenses were $8.2 million essentially flat year over year. Inside that number, we reallocated meaningfully. Litigation costs declined by approximately $2 million as we work through legacy matters and we redeployed that capacity to achieve the substantial R&D progress and commercial readiness for NXT-41x.

總營業費用為 820 萬美元，年對年基本持平。在這個數字之內，我們做了顯著的重新配置。隨著我們處理歷史遺留事項，訴訟成本約下降 200 萬美元，我們並將這部分資源重新投入，以推動 NXT-41x 的重大研發進展與商業化就緒。

Net loss order was $7.5 million compared to a net loss of $3.9 million in the prior year period. Adjusted EBITDA was a loss of $4.4 million compared to a loss of $2.8 million a year ago. Importantly, the increase in net loss was driven primarily by non-cash items and other expense, specifically, the revaluation of warrant liabilities and not by any deterioration in the underlying operating business.

淨損失為 750 萬美元，去年同期淨損失為 390 萬美元。調整後 EBITDA 為虧損 440 萬美元，去年為虧損 280 萬美元。重要的是，淨損失增加主要由非現金項目與其他費用所驅動，具體而言是認股權證負債的重估，而非基礎營運業務惡化所致。

From a liquidity perspective, we ended the quarter with $28.5 million in cash on hand, plus the $8 million dollar escrow associated with the BioEnvelope divestiture, which we expect to be released in the fourth quarter of this year. Combine that represents approximately $36.5 million in cash and escrowed receivables.

就流動性而言，本季末我們持有現金 2,850 萬美元，另加上與 BioEnvelope 剝離相關的 800 萬美元託管款，我們預期將於今年第四季解除託管。合計約為 3,650 萬美元的現金與託管應收款。

We believe our current capital position provides the resources necessary to support our planned regulatory and operational milestones. For shares outstanding at quarter end, the company had approximately $44.2 million common shares outstanding, and $3.2 million pre-funded warrants representing 47.4 million common equivalents outstanding.

我們相信目前的資本部位足以支援我們規劃中的法規與營運里程碑。就季末流通在外股數而言，公司約有 4,420 萬股普通股流通在外，以及 320 萬份預先出資認股權證，合計代表 4,740 萬股普通股等值。

Now, let's look ahead at the catalyst calendar. We continue to actively work towards our strategic transactions. The SimpliDerm and Cardiovascular processes that Randy discussed. Each of these would further bolster the balance sheet. We continue to anticipate NXT-41x FDA clearance in the fourth quarter of 2026. And in the first half of 2027, we anticipate FDA clearance of NXT-41x.

現在，讓我們展望未來的催化劑時程。我們持續積極推進策略交易，也就是 Randy 所提到的 SimpliDerm 與心血管業務流程。這兩項交易各自都將進一步強化資產負債表。我們仍預期 NXT-41x 將於 2026 年第四季取得 FDA 核准。而在 2027 年上半年，我們預期 NXT-41x 取得 FDA 核准。

In the second half of 2027, we anticipate commercialization and the focused NXT-41x soft launch. Overall, we believe the first quarter reflects continued execution against our strategic priorities. We are maintaining financial discipline while investing in the core capabilities required to support the NXT-41x opportunity.

在 2027 年下半年，我們預期將進行商業化並推動聚焦的 NXT-41x 軟性上市。整體而言，我們認為第一季反映了我們持續依策略優先事項執行。我們在維持財務紀律的同時，也投資於支援 NXT-41x 機會所需的核心能力。

Now taking a step back, we believe Elisha today represents a unique combination of attributes. We have an established, drug-eluting biomatrix platform. We have prior experience successfully commercializing and monetizing products developed on this technology, most notably the sale of EluPro to Boston Scientific for $88 million.

現在退一步來看，我們認為 Elisha 目前具備獨特的多項特質組合。我們擁有成熟的藥物釋放生物基質平台。我們也有過往成功商業化並將基於此技術開發的產品變現的經驗，其中最具代表性的是以 8,800 萬美元將 EluPro 出售給 Boston Scientific。

We have existing GMP manufacturing infrastructure that is now online. We have growing regulatory clarity from our productive dialogue with FDA. And we are pursuing a large market opportunity, $1.5 billion in the US, with a meaningful and well-documented unmet medical need. All the pieces are coming together and most importantly, we have a company capable of creating meaningful value for surgeons, for hospitals, for shareholders, and most importantly, for patients. We have the platform, we have the market, we have the team, and we have the resources to make it happen.

我們現有的 GMP 製造基礎設施如今已上線。我們也透過與 FDA 的富有成效對話，獲得更清晰的法規路徑。同時，我們正追求一個龐大的市場機會：美國 15 億美元市場，且存在具意義且有充分文獻記載的未被滿足醫療需求。所有拼圖正在到位；更重要的是，我們擁有一家能為外科醫師、醫院、股東，最重要的是為病患創造實質價值的公司。我們有平台、有市場、有團隊，也有資源把它實現。

Operator, we're now ready to open the line for questions.

接線員，我們現在準備開放提問。

(Operator Instructions) Frank Takkinen, Lake Street Capital Markets.

（接線員指示）Lake Street Capital Markets 的 Frank Takkinen。

Great. Thank you for taking the questions. Congrats on all the progress. I was hoping to start with one on the follow-up. I know you said you wouldn't divulge too much detail on it, but I'd be remiss if I didn't ask. So maybe how I will ask is, if I heard you correctly, you said incrementally more confident.

很好，謝謝讓我提問。恭喜各項進展。我想先從追問的一題開始。我知道你說不會透露太多細節，但如果我不問就說不過去了。所以也許我會這樣問：如果我沒聽錯的話，你說你們是「逐步更有信心」。

So maybe the way for us to understand it is no surprises with perhaps a more detailed roadmap for 41x. Is that a fair way to think about it? And any other detail you would provide.

所以，也許我們理解它的方式是：不會有意外，並且可能會提供一份更詳細的 41x 路線圖。這樣想是否合理？以及你還能提供任何其他細節嗎？

Yeah. The way I would describe it is one, any time that you submit something to the FDA, you submit to a particular group. And so while it's the same regulatory pathway that we use with EluPro, we went from cardiovascular with EluPro over to plastic and reconstructive surgery. And what we found with the review team in plastic reconstructive surgery, which is unique than the one in cardiovascular, is a group that is significantly more collaborative and engaging and very proactive in the review process.

是的。我會這樣描述：第一，任何時候你向 FDA 提交資料，你都是提交給某一個特定的審查小組。因此，雖然我們在 EluPro 上使用的是同一條監管途徑，但我們從 EluPro 的心血管領域轉到整形與重建外科。我們發現，整形重建外科的審查團隊（這點與心血管領域的團隊不同）是一個明顯更具協作性、更投入，且在審查過程中非常主動的團隊。

And so given how sort of early on we are in the review, we've had a tremendous amount of dialogue back and forth, substantive communication, direct communication with the agency on this. Not just the perfunctory type of letters and initial things that might go back and forth at this stage, but real, serious, meaningful conversations in a productive and collaborative fashion. And that's obviously been helpful in 41 and 41 is moving along the way we anticipated 41 would move along,

因此，鑑於我們目前仍處於審查的相對早期階段，我們已經有大量來回的對話、實質性的溝通，並且就此與主管機關進行直接溝通。不只是這個階段可能會出現的那種例行性信函與初步往來，而是真正嚴肅、重要且有意義的對話，以具建設性與協作性的方式進行。這顯然對 41 很有幫助，而 41 也正如我們預期地推進中，

But sort of keep in mind, as we do, I would hope, Frank, that our eye is actually on the prize and the prize is 41x. And what we're really doing with 41 is making sure that our 41x submission is the highest quality submission. We can have it, that it's on time, and most importantly, that 41x gets approved when we anticipated it. And the interactions we've had so far in the 41 process have given us a lot of confidence in where we're going with 41x.

但請記住，就像我們一樣，我也希望，Frank，我們的目光其實是放在最終目標上，而那個目標就是 41x。我們在 41 上真正做的，是確保我們的 41x 申請是最高品質的申請：能準時提交，更重要的是，41x 能在我們預期的時間獲得核准。而我們迄今在 41 流程中的互動，讓我們對 41x 的推進方向更有信心。

I hope that adds sort of the color and commentary around what's going on.

希望這能為目前的進展提供一些背景與說明。

No, that's perfect. I appreciate that very much. Maybe on the -- some of the new commercial comments. Thanks for that color. It's very educational. I was hoping to ask about maybe a question that's a little bit too far out right now to be thinking about, but I'm sure you're starting to sketch it up.

不，這非常好。我非常感謝。也許談談——一些新的商業化評論。謝謝你提供的背景，這很有教育意義。我想問一個問題，可能現在想還有點太早，但我相信你們已經開始勾勒了。

How do you think about rep hiring? Obviously, a very concentrated call point. I think in the past you've used a hybrid of kind of internal as well as 1099s. Maybe talking about that split and when you start to maybe bring on some of that early talent.

你們如何看待業務代表的招募？顯然，拜訪對象非常集中。我記得過去你們採用過一種混合模式，既有內部人員也有 1099 合約人員。能否談談這個比例，以及你們何時開始引進一些早期人才？

Right. So it's certainly a little too early to lay out the full plan. We'll be doing that more now that Pete's on, but I do have a couple of comments on it.

對。所以現在確實還有點早，還無法完整攤開整體計畫。我們會在 Pete 到位後更深入推進，但我可以先分享幾點看法。

So the first -- one of the thing Pete's doing is Pete's doing a really nice job of going out and assessing the market both qualitatively and quantitatively, Frank. And I mean, it's when you bring a sophisticated guy in house, right? This is what they do.

首先——Pete 正在做的一件事，是他在質性與量化兩個層面對市場進行評估，做得非常好，Frank。我的意思是，當你把一位成熟老練的人才延攬進公司，對吧？這就是他們會做的事。

Quantitatively, it's great to know, hey, what's the actual infection rate? Where are all the procedures done? How -- what are the kinds of infections and complications are they seeing at different hospitals and centers and things like that. The qualitative side of it is what are the surgeons think is going on? I mean, you're --- anyone that's spent any time with a surgeon is their perception of the problem can oftentimes be very different than the actual problem.

在量化方面，能知道例如：實際感染率是多少？所有手術都在哪些地方進行？——不同醫院與中心看到的是哪些類型的感染與併發症等等，這些都很重要。質性方面則是：外科醫師認為發生了什麼？我的意思是，你——任何跟外科醫師相處過一段時間的人都知道，他們對問題的感受與認知，往往可能與實際問題非常不同。

And the gap between those two is actually where the real marketing plan and genius and opportunity come about and take shape. So what we're seeing and what Pete's already uncovered is when you start looking for -- when you start looking at the high concentration center -- so I think it was 585. I account for 75% of the market, and then even that ends up being super concentrated. We have $300 billion of market opportunity in just 50 accounts, right?

而這兩者之間的落差，正是實際行銷計畫、洞見、以及機會真正形成並成形的地方。所以我們看到、而且 Pete 已經挖掘出來的是：當你開始尋找——當你開始看那些高度集中中心——我想是 585 家，佔了 75% 的市場，而即便如此，市場仍然是高度集中。僅僅 50 個客戶帳戶，就有 3,000 億美元的市場機會，對吧？

I mean, let's put that into perspective with what we did with EluPro. We took 12 direct reps with EluPro. Paired them up with a handful of 1099s and in nine months, they activated 193 VAC accounts, right? (inaudible) submission is a 193 accounts. That would be like, I don't know, a $0.5 billion of market opportunity in breast reconstruction, right? It's absolutely incredible what's going on here.

我的意思是，把這放到我們在 EluPro 上做的事情來看。我們用 EluPro 配置了 12 位直營業務代表，搭配少數 1099 合約人員，在九個月內就啟動了 193 個 VAC 帳戶，對吧？（聽不清）提交的是 193 個帳戶。若換算到乳房重建領域，那大概就是——我不知道——5 億美元的市場機會，對吧？這裡正在發生的事情真的令人難以置信。

And then just up -- just to go on, I get really excited about this as you can tell, Frank. But another thing that Pete uncovered is if you look at the postoperative complications that are happening. And we mentioned in the press release that he's confirmed the sort of the market size and its concentration effect that we're seeing, but also the severity. It's really interesting because when you look at the complication rates of these high volume centers, they are really high.

然後再補充——如你所見，我對此非常興奮，Frank。但 Pete 另外挖掘到的一點是：如果你看正在發生的術後併發症。我們在新聞稿中提到，他已確認我們看到的市場規模與集中效應，但也包括嚴重程度。這非常有意思，因為當你看這些高量中心的併發症發生率時，真的非常高。

You're looking easily at 30% complication rates at these high volume centers and so it's kind of nice that the earliest places to go to get some big wins are actually also the ones that need the most help. And intuitively, if you sort of think about it, that's not too surprising because these are the big centers where people are getting referred with the more complicated cases that are -- that have the comorbidity that lead to infection that require the more radical mastectomies that -- and all of those factors that lead to post-operative and infection. But it's really, really gratifying to see it come together.

在這些高量中心，你很容易看到 30% 的併發症發生率，所以某種程度上很不錯的是，最早能取得重大成果的地方，恰恰也是最需要幫助的地方。直覺上，如果你稍微想一想，這也不太令人意外，因為這些大型中心會接收轉診而來、病情更複雜的個案——有共病而導致感染、需要更激進乳房切除術的個案——以及所有那些導致術後併發症與感染的因素。但看到這一切逐步整合起來，真的非常令人欣慰。

So we will have more -- just to go back to your actual question, Frank. We will have more on the launch structure coming up. I think probably by the next conference call, we'll be laying that out a little more clearly with a little more sophistication.

所以回到你真正的問題，Frank，我們之後會提供更多——關於上市（launch）架構的資訊。我想大概到下一次電話會議時，我們會以更清楚、也更成熟的方式把它說明得更完整一些。

But boy, in 60 days, the man has hit the ground running and has confirmed what we know and then has taken it really to the next level with this. And it's super exciting, particularly when you put it in the context of what we're able to accomplish with little old EluPro. And now you talk about game-changing 41x and we're -- we can't wait.

不過，短短 60 天，他就已經全速展開並確認了我們所知道的事情，並且把它真正提升到下一個層次。這非常令人振奮，尤其是把它放在我們用小小的 EluPro 就能達成的成果背景下來看。現在再談到具有顛覆性的 41x——我們等不及了。

Very helpful. Maybe again just my last one. How do you think about maybe timelines around SimpliDerm and Cardiovascular understanding? It's always challenging to predict, but any wide goal posts you'd provide?

非常有幫助。也許再問最後一個。你們如何看待 SimpliDerm 與心血管（Cardiovascular）方面的時程？這總是很難預測，但你能否提供一些大致的時間範圍？

Well, we started the SimpliDerm process -- we announced that on our last call, interest was very robust. I think we had something like 38 targets engaged in it. I would say we have confidence -- we have pretty good confidence that a transaction is coming together, Frank.

嗯，我們已經啟動 SimpliDerm 的流程——我們在上一次電話會議上宣布過，市場興趣非常強勁。我想我們大概有 38 個目標方參與。我會說，我們有信心——我們相當有信心，一筆交易正在成形，Frank。

I just -- it's like trying to pick the final four or enrollment in the clinical trial. Like trying to time when a deal, like a divestiture is going to happen. Just leads to bad promises and expectations. I will say we are very pleased with how the SimpliDerm process is going. We're looking for a high-quality deal and we think we're on track to get one. But until it's done, it's not done.

只是——這就像要猜 NCAA 最終四強，或是臨床試驗的入組進度一樣。試圖去精準抓一筆交易、例如資產剝離（divestiture）何時會發生，只會導致不好的承諾與預期。我可以說，我們對 SimpliDerm 流程的進展非常滿意。我們在尋找一筆高品質的交易，也認為我們正朝著取得它的方向前進。但在完成之前，一切都還不算完成。

And then on the Cardiovascular side, the air was pretty much just a lot of surprise from the upside because we got actually a number of inbound requests on the Cardiovascular side. And they're -- there's high-quality interest in that product as well. And as we think about strategic positioning of the company, and you could probably tell, right, we're really, really convinced in the 41x opportunity that lies ahead.

至於心血管方面，情況幾乎是——我們在上行端感到相當意外，因為我們其實收到了不少心血管產品的主動洽詢。而且——對該產品也有高品質的興趣。當我們思考公司的策略定位時，你大概也看得出來，對吧，我們對前方的 41x 機會非常、非常有信心。

Not just the capital that this would add to our balance sheet and strengthen our balance sheet even further than where it is, but also the strategic focus and the alignment and the management attention and all of those other things. These are two great product lines that are used surgically every day and patients benefit from them every day. But they're just not where we're going as a company, and it will -- I think both of these will have a meaningful impact to our balance sheet and to our strategic focus. So did that help?

不只是這些交易能為我們的資產負債表增加資本、讓資產負債表比現在更強健，也包括策略聚焦、方向一致性、管理層注意力，以及所有其他因素。這兩條產品線都很棒，每天都在手術中使用，病患每天也都從中受益。但它們並不是我們公司未來要走的方向；我認為這兩者都將對我們的資產負債表與策略聚焦帶來實質影響。所以這樣有幫助嗎？

Yep. Very helpful. Thank you. I appreciate the color as always.

有。非常有幫助。謝謝。如往常一樣，我很感謝你提供的背景說明。

Thank you. Ladies and gentlemen, that does end our Q&A session and concludes today's conference call. Thank you for participating. You may now disconnect.

謝謝。各位女士先生，我們的問答環節到此結束，也結束今天的電話會議。感謝各位參與。您現在可以掛線。