Spectral AI Inc (MDAI) 2025 Q4 法說會逐字稿

Good afternoon, and welcome to the Spectral AI Fourth Quarter and Full Year 2025 Financial Results Conference Call. Please -- please note, this event is being recorded. I would now like to turn the conference over to Devin Sullivan, Managing Director of the Equity Group. Please go ahead.

各位下午好，歡迎參加 Spectral AI 2025 年第四季暨全年財務業績電話會議。請——請注意，本活動正在錄音。我現在想把會議交給 Equity Group 董事總經理 Devin Sullivan。請開始。

Thank you, Gary. Good afternoon, everyone, and thank you for joining us today for Spectral AI's 2025 Fourth Quarter and Full Year Financial Results Conference Call. Our speakers for today will be Vincent Capone, the company's Chief Executive Officer; and Thomas Speith, our Corporate Controller. Before we begin, I'd like to remind everyone that during this call, certain statements made are forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the company's strategy, plans, objectives, initiatives and financial outlook.

謝謝你，Gary。各位下午好，感謝各位今天參加 Spectral AI 2025 年第四季暨全年財務業績電話會議。今天的講者為公司執行長 Vincent Capone，以及公司財務控制主管（Corporate Controller）Thomas Speith。在開始之前，我想提醒各位，本次電話會議中所作的某些陳述，屬於 1995 年《美國私人證券訴訟改革法》（United States Private Securities Litigation Reform Act of 1995）安全港條款所定義的前瞻性陳述，包括關於公司策略、計畫、目標、倡議與財務展望的陳述。

When used in this call, the words estimates, projected, expects, anticipates, forecasts, plans, intends, believes, seeks, may, will, should, future, propose and variations of these words or similar expressions or the negative versions of such words or expressions are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the company's control that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements.

在本次電話會議中，使用「估計（estimates）」、「預測（projected）」、「預期（expects）」、「預料（anticipates）」、「預報（forecasts）」、「計畫（plans）」、「意圖（intends）」、「相信（believes）」、「尋求（seeks）」、「可能（may）」、「將（will）」、「應（should）」、「未來（future）」、「提議（propose）」及其變化形式或類似表達，或上述詞語／表達的否定形式，旨在識別前瞻性陳述。這些前瞻性陳述並非對未來績效、狀況或結果的保證，且涉及多項已知與未知的風險、不確定性、假設及其他重要因素，其中許多因素不在公司控制範圍內，可能導致實際結果或結局與前瞻性陳述中所討論者存在重大差異。

As such, listeners are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the Risk Factors section of the company's filings with the SEC, including the registration statement and other documents filed by the company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. With that, I'd now like to turn the call over to Vincent Capone, Spectral AI's Chief Executive Officer. Vince, please go ahead.

因此，提醒聽眾不要對任何前瞻性陳述過度依賴。投資人應審慎考量前述因素，以及公司向美國證券交易委員會（SEC）提交之文件（包括註冊聲明及公司提交的其他文件）中「風險因素」章節所描述的其他風險與不確定性。這些申報文件識別並說明了其他重要風險與不確定性，可能導致實際事件與結果與前瞻性陳述所載內容存在重大差異。接下來，我想把電話會議交給 Spectral AI 執行長 Vincent Capone。Vince，請開始。

Thanks, Devin, and thank you all for joining us today. We issued our earnings release this afternoon, which contains additional details of our operating results. We will also file our 10-K with the SEC later this evening. Today, I will focus my remarks on our year-end review and corporate developments, and our Controller, Tom Spieth, will take us through our key financial metrics. We will then open the conference call up for questions.

謝謝你，Devin，也感謝各位今天加入我們。我們今天下午已發布財報新聞稿，其中包含我們營運結果的更多細節。我們也將在今晚稍晚向 SEC 提交 10-K。今天我將把重點放在年終回顧與公司發展動態，而我們的控制主管 Tom Spieth 將帶領大家檢視關鍵財務指標。之後我們將開放提問。

2025 was a pivotal year for Spectral AI, in which we made great progress along a number of fronts in support of achieving our primary goal of commercializing the Deep U system for the burn indication. The DeepView system is a diagnostic tool that empowers medical personnel to make quick data-driven decisions regarding whether a burn wound will heal on its own or if it requires significant medical intervention. This currently unmet clinical need is dramatically magnified in the event of a mass casualty burn incident. -- where the ability to triage burn patients rapidly and properly would be crucial in allocating valuable resources and managing the surgical burden. Our DeepView system is designed to assist the U.S. government in preparing for any such mass casualty event.

2025 年對 Spectral AI 而言是關鍵的一年；我們在多個面向取得重大進展，以支持達成我們的主要目標——將 Deep U 系統用於燒燙傷適應症的商業化。DeepView 系統是一項診斷工具，可協助醫護人員快速做出以數據為基礎的決策，判斷燒燙傷傷口是否能自行癒合，或是否需要重大醫療介入。當發生大規模傷亡的燒燙傷事件時，這項目前尚未被滿足的臨床需求會被大幅放大——在那種情況下，能否快速且正確地分級檢傷（triage）燒燙傷病患，對於分配寶貴資源與管理手術負荷至關重要。我們的 DeepView 系統旨在協助美國政府為任何此類大規模傷亡事件做好準備。

As many of you may be aware, a hallmark event for our company was the June 2025 submission of our de novo application to the FDA. This submission was the culmination of years of work by our talented, hard-working and dedicated team. Following our submission and as anticipated, we received an additional information notification letter from the FDA, which we timely and completely responded to just earlier this month. We are maintaining an active dialogue with the FDA and its feedback has been consistent with our expectations. We are hopeful for a positive response from the FDA before the end of the second quarter of this year.

如各位所知，我們公司的一個里程碑事件，是於 2025 年 6 月向 FDA 提交 de novo 申請。這次提交是我們才華洋溢、勤奮且投入的團隊多年努力的成果。提交後且如預期，我們收到 FDA 的補充資訊通知函，我們也在本月稍早即時且完整地回覆。我們與 FDA 持續保持積極對話，其回饋與我們的預期一致。我們希望在今年第二季結束前能收到 FDA 的正面回覆。

Now to give a review of the 2025 year. In March 2025, we completed our burn validation study. This 15-month study represented one of the largest burn trials ever conducted in the United States with data obtained from 164 adult and pediatric patients across 15 burn centers and emergency departments in the United States. In this study, the DeepView system significantly outperformed the clinical judgment of burn physicians. Following our anticipated FDA clearance, we will initiate an outcome study to measure the real-world impact of the DeepView system within the hospital setting.

接下來回顧 2025 年。2025 年 3 月，我們完成了燒燙傷驗證研究。這項為期 15 個月的研究，是美國迄今規模最大的燒燙傷試驗之一，資料來自美國 15 家燒燙傷中心與急診部門的 164 名成人與兒科病患。在該研究中，DeepView 系統的表現顯著優於燒燙傷醫師的臨床判斷。在預期取得 FDA 核准後，我們將啟動一項結果研究（outcome study），以衡量 DeepView 系統在醫院環境中的真實世界影響。

This study will focus on the benefits across patients' journeys and clinician workflows. The results of the burn validation study were submitted as part of our de novo application to the FDA. More broadly, the use of our DeepView system in these burn centers and emergency departments raised awareness of the technology among a larger set of likely users of the device if approval from the FDA is ultimately obtained. By way of scale, in the United States, there are approximately 125 burn centers, 700 trauma centers and 5,400 federal and community hospitals with emergency rooms where the burn patients are most likely to present upon injury.

該研究將聚焦於病患就醫旅程與臨床人員工作流程的效益。燒燙傷驗證研究的結果已作為我們向 FDA 提交 de novo 申請的一部分。更廣泛而言，在這些燒燙傷中心與急診部門使用 DeepView 系統，也提升了更大範圍潛在使用者對該技術的認知——前提是最終取得 FDA 核准。就規模而言，在美國約有 125 家燒燙傷中心、700 家創傷中心，以及 5,400 家設有急診室的聯邦與社區醫院；燒燙傷病患受傷後最可能首先前往這些機構就診。

Let me next turn to a discussion regarding our BARDA contract. We have had a long-term significant and strong partnership with the Biomedical Advanced Research and Development Authority since 2013. Its support has been instrumental in our product development to date and most notably related to the Project BioShield contract that we signed in September of 2023 with a value of up to $150 million, $55 million of which were awarded at that time as part of the contract's base phase. This BARDA funding has supported product development as well as funding extensive U.S.-based studies to validate our DeepView technology and our AI algorithm in emergency departments, trauma and burn centers.

接著我談談我們的 BARDA 合約。我們自 2013 年起即與生物醫學先進研究與發展管理局（Biomedical Advanced Research and Development Authority, BARDA）建立長期、重要且穩固的合作關係。BARDA 的支持對我們迄今的產品開發至關重要，尤其是我們於 2023 年 9 月簽署的 Project BioShield 合約，總價值最高可達 1.5 億美元，其中 5,500 萬美元在當時作為合約基礎階段（base phase）的一部分即已授予。這筆 BARDA 資金支持了產品開發，並資助在美國進行的大量研究，以在急診部門、創傷中心與燒燙傷中心驗證我們的 DeepView 技術與 AI 演算法。

Last week, as we announced, BARDA reaffirmed its commitment to the development of the DeepView system by awarding Spectral AI $31.7 million of advanced funding to accelerate and support additional feature aspects of our innovative AI-driven diagnostic device. In connection with this award, we have also committed to provide an additional $9.7 million to the total overall development costs associated with these advancements. The acceleration of the second phase of our BARDA contract will enable us to expedite further development of the Deep U system, most notably with our total body surface area measurement tool and our EHR integration.

如我們上週所公告，BARDA 透過授予 Spectral AI 3,170 萬美元的預先資金（advanced funding），重申其對 DeepView 系統開發的承諾，以加速並支持我們這款創新 AI 驅動診斷裝置的額外功能面向。配合此項授予，我們也承諾就與這些改進相關的整體開發成本，額外投入 970 萬美元。BARDA 合約第二階段的加速推進，將使我們能加快 Deep U 系統的進一步開發，尤其是我們的全身表面積（total body surface area）測量工具，以及與 EHR 的整合。

Our contract with BARDA upon an FDA approval of our device also includes a provision that will allow BARDA to subsidize an initial sale and distribution of up to 30 Deep U systems in burn centers in key regions across the United States. This contract also allows a further subsidy by BARDA for an additional 140 DepU systems in burn centers and trauma Level 1 emergency departments across the United States.

我們與 BARDA 的合約在裝置獲 FDA 核准後，也包含一項條款，允許 BARDA 補助在美國關鍵地區的燒燙傷中心，初期最多 30 套 Deep U 系統的銷售與配送。該合約亦允許 BARDA 進一步補助，在全美各地的燒燙傷中心與創傷第一級（Level 1）急診部門，再額外提供最多 140 套 DepU 系統。

Internationally, the Deep U systems that we have placed in the United Kingdom have generated positive user feedback. As previously shared, we have obtained U.K. CA authorization for the burn indication in 2024. In 2026, following a positive FDA determination of our de novo submission, we will be updating our U.K. CA authorization to include the improved DeepView system as we have submitted it to the FDA. Thereafter, we anticipate initial sales in the U.K., Australia or the Gulf Cooperation Council nations to begin in late 2026 following such U.K. CA expanded authorization.

在國際方面，我們部署於英國的 Deep U 系統已獲得正面的使用者回饋。如先前所分享，我們已於 2024 年取得英國 U.K. CA 對燒燙傷適應症的授權。2026 年，在 FDA 對我們的 de novo 提交作出正面決定後，我們將更新 U.K. CA 授權，納入我們已提交給 FDA 的改良版 DeepView 系統。其後，我們預期在取得該 U.K. CA 擴增授權後，於 2026 年底開始在英國、澳洲或海灣合作委員會（Gulf Cooperation Council）國家進行初期銷售。

While there will be a transition phase following our anticipated FDA approval, we will begin commercial activities in earnest in 2026 with our existing manufacturing relationships and expanding our sales team to facilitate the first commercial sales in our company's history. We believe we have a clear strategy to drive rapid market adoption, both inside and outside of our BARDA relationship. I would also like at this time to share some additional information about our handheld device, which we continue to develop as part of our Department of Defense contract through the contracting consortium called MTEC.

雖然在我們預期獲得 FDA 核准後將會有一段過渡期，但我們將在 2026 年憑藉既有的製造合作關係並擴編銷售團隊，正式啟動商業化活動，以促成公司史上首次商業銷售。我們相信，無論是在 BARDA 合作關係之內或之外，我們都有清晰的策略來推動市場快速採用。此外，我也想在此分享一些關於我們手持式裝置的補充資訊；該裝置是我們透過名為 MTEC 的承包聯盟、在國防部合約之下持續開發的一部分。

In late 2025, we signed a no-cost extension of our current Phase II contract to extend it through June 30, 2026. Consistent with our current contract requirement, we anticipate delivering a fully functioning prototype of our handheld device by the end of the second quarter of 2026. After such time, we will also determine if there are any additional scope items that we can complete as part of that contract before the end of the third quarter of 2026.

在 2025 年底，我們簽署了目前第二期（Phase II）合約的零成本展延（no-cost extension），將合約延長至 2026 年 6 月 30 日。依照現行合約要求，我們預期在 2026 年第二季末前交付一台可完全運作的手持式裝置原型。其後，我們也將評估在 2026 年第三季末前，是否還有任何可在該合約範圍內完成的額外工作項目。

Phase II of the MTEC contract is scheduled to be reviewed and awarded by the end of the fourth quarter of 2026, and and we are hopeful that we will be asked to bid on such work. We also anticipate leveraging any approvals at the FDA for our cart-based DeepView system as a predicate to our handheld device. At such time, we will look to obtain a 510(k) approval of our handheld device after receiving approvals for the cart-based DeepView system, currently under review by the FDA.

MTEC 合約的第二期預計將於 2026 年第四季末前完成審查並授標，而我們也希望能被邀請就該工作投標。我們亦預期，將以我們推車式（cart-based）DeepView 系統在 FDA 取得的任何核准作為手持式裝置的前置依據（predicate）。屆時，在推車式 DeepView 系統（目前正由 FDA 審查中）取得核准後，我們將尋求為手持式裝置取得 510(k) 核准。

Before turning things over to Tom, I am happy to say that we entered 2026 in the strongest liquidity and financial position in our recent history, and certainly during my tenure with our company. Our cash position of more than $15 million at year-end tripled from December 31, 2024, and we have aligned our operating expense profile with our strategic priorities. This allows us to pursue our growth objectives, both preapproval and hopefully, post approval from a position of strength and with a sufficient cash runway.

在把時間交給 Tom 之前，我很高興地表示，我們以近年來、且確實是在我任職期間最強的流動性與財務狀況進入 2026 年。我們在年末的現金部位超過 1,500 萬美元，較 2024 年 12 月 31 日增加至三倍，且我們已將營運費用結構與策略優先事項對齊。這使我們能在核准前、以及希望在核准後，以更強的基礎並具備充足的現金續航力（cash runway）來追求成長目標。

While I have participated on numerous calls in the past, I also want to recognize that this is my first call as the company's Chief Executive Officer; I want to thank the Board for their continued confidence in me as well as the amazing team of people I am fortunate to work with every day. They are driving our success. I am grateful to lead Spectral to bigger and better things.

雖然我過去曾參與多次電話會議，但我也想特別說明，這是我以公司執行長身分主持的第一次電話會議；我要感謝董事會持續對我的信任，也感謝我每天有幸與之共事的優秀團隊。他們正推動我們的成功。我很感激能帶領 Spectral 邁向更大、更好的未來。

With that said, I'll now turn over the conference call to Tom for a review of our financial results.

話不多說，我現在把電話會議交給 Tom，請他回顧我們的財務結果。

Thanks, Vince. As Vince noted, we had a strong year and believe that we have the financial performance in place to continue our R&D efforts and evolve into commercial business. Beginning with the fourth quarter. Research and development revenue for Q4 2025 was $3.8 million, compared to $7.6 million, reflecting the anticipated reduction in research direct labor, clinical trial and other reimbursed study costs relative to 2024, as the company moved closer to completion of the base phase under our contract with BARDA, we call the BARDA PBS contract. Gross margin for Q4 2025 was 39.8% compared to $44.0, due primarily to a lower percentage of reimbursed direct labor as a component of overall revenue from the BARDA PBS contract.

謝謝你，Vince。正如 Vince 所提到的，我們今年表現強勁，並相信我們已具備足夠的財務表現來持續推進研發工作，並逐步演進為商業化企業。先從第四季開始。2025 年第四季研發收入為 380 萬美元，較 760 萬美元下降，反映出相較 2024 年，隨著公司更接近完成與 BARDA 合約下的基礎階段（base phase）（我們稱之為 BARDA PBS 合約），研究直接人力、臨床試驗及其他可報銷研究成本如預期降低。2025 年第四季毛利率為 39.8%，相較於 44.0%，主要係因 BARDA PBS 合約收入中，可報銷直接人力占整體收入的比例較低所致。

General and administrative expenses in Q4 2025 were $4.0 million, down from $4.5 million in Q4 of 2024, and reflecting lower spend on third-party accounting and legal providers. Net income for Q4 2025 was $0.6 million, or $0.02 per diluted share compared to a net loss of $7.7 million, or a negative $0.41 per diluted share in the fourth quarter of 2024. Net income in Q4 2025 included a $4 million gain in the fair value of the company's warrant liability as compared to a net loss of $5.4 million.

2025 年第四季一般及行政費用為 400 萬美元，較 2024 年第四季的 450 萬美元下降，反映對第三方會計與法律服務供應商的支出降低。2025 年第四季淨利為 60 萬美元，或稀釋後每股盈餘 0.02 美元；相較之下，2024 年第四季為淨損 770 萬美元，或稀釋後每股虧損 0.41 美元。2025 年第四季淨利包含公司認股權證負債公允價值變動帶來的 400 萬美元利益；相較之下，先前為淨損 540 萬美元。

Now we turn to the full year. Research and development revenue decreased to $19.7 million from $29.6 million reflecting the anticipated overall reduction in the company's reimbursed costs associated with the BARDA PBS contract during 2025, following the company's submission of this de novo application to the FDA. Gross margin was stable at 45.4%, compared to 44.9%, reflecting a consistent mix of direct labor as a percentage of the total work performed on the BARDA PBS contract from the prior year.

接著看全年。研發收入由 2,960 萬美元下降至 1,970 萬美元，反映公司在向 FDA 提交此 de novo 申請後，2025 年與 BARDA PBS 合約相關之可報銷成本如預期整體降低。毛利率維持穩定於 45.4%，相較於 44.9%，反映直接人力占 BARDA PBS 合約總工作量的比例與前一年一致。

G&A declined to $17.5 million from $19.9 million, reflecting a continued focus on operating efficiencies at the company. Our net loss for the year was $7.6 million, or a negative $0.29 per diluted share compared to a net loss of $15.3 million, or a negative $0.85 per diluted share, primarily due to the change in the fair value of the company's warrant likely. Reduced borrowing related costs of $1.5 million net of amortization of debt discount and improved operating efficiencies.

一般及行政費用由 1,990 萬美元降至 1,750 萬美元，反映公司持續聚焦營運效率。全年淨損為 760 萬美元，或稀釋後每股虧損 0.29 美元；相較之下，前一年淨損為 1,530 萬美元，或稀釋後每股虧損 0.85 美元，主要係因公司認股權證公允價值變動，以及借款相關成本減少 150 萬美元（扣除債務折價攤銷後），並且營運效率提升。

As of December 31, 2025, we had approximately 30.7 million shares outstanding. With respect to our financial condition, as of December 31, 2025, cash improved to $15.4 million from $5.2 million in December 31, 2024, reflecting previously announced debt equity financings completed during the year as well as warrant stock option exercises. Total debt was $8.5 million. I will now turn the call back to Vince.

截至 2025 年 12 月 31 日，我們約有 3,070 萬股流通在外。就財務狀況而言，截至 2025 年 12 月 31 日，現金由 2024 年 12 月 31 日的 520 萬美元提升至 1,540 萬美元，反映公司於年度內完成先前已公告的債務與股權融資，以及認股權證與員工股票選擇權的行使。總負債為 850 萬美元。我現在把電話會議交回給 Vince。

Thanks, Tom. Before turning things over for questions, I would like to address our 2026 outlook. For 2026, we are forecasting revenue of approximately $18.5 million, which includes the effect of the new BARDA funding. This guidance does not include any significant contributions from the sale of the DPU system. With that, I will open up the floor to any questions.

謝謝你，Tom。在進入提問之前，我想談談我們對 2026 年的展望。就 2026 年而言，我們預估營收約為 1,850 萬美元，其中包含新增 BARDA 資金的影響。此一指引未包含 DPU 系統銷售所帶來的任何重大貢獻。接下來，我將開放現場進行提問。

(Operator Instructions) Our first question is from Ryan Zimmerman with BTIG.

（接線員指示）我們的第一個問題來自 BTIG 的 Ryan Zimmerman。

Let me just start by saying congrats on the BARDA funding, and Vince for new role. Maybe as we think about your transition into a commercial organization, this year, Vince, you could talk to us a little bit about kind of how you're thinking about preparing for commercialization, what you need to do to get the organization ready to be a commercial organization and so forth. And then I have a few follow-ups.

我先說聲恭喜獲得 BARDA 資金，也恭喜 Vince 擔任新職務。或許在你們轉型為商業化組織的過程中，今年 Vince 你可以跟我們談談，你如何思考商業化準備工作、需要做哪些事情讓組織具備商業化公司的能力等等。之後我還有幾個追問。

Good to hear from you, Ryan. So I mean, there's a few things that we're working on in preparation for what we believe will be hopefully, FDA approval. Some of that is, we've already started our search for a new Chief Commercial Officer. We have also engaged delayed consulting to help us with our strategic plan for commercialization moving forward, both in the U.S. and overseas, that is already underway.

很高興聽到你的聲音，Ryan。就我們而言，為了我們相信、也希望能取得 FDA 核准，我們正在做幾件準備工作。其中之一是，我們已經開始尋找新的首席商務長（Chief Commercial Officer）。我們也已聘請 Delayed Consulting 協助我們制定未來的商業化策略計畫，涵蓋美國與海外市場；這項工作已經在進行中。

We continue to have plans in place to expand our sales team. I'd like to do that in concert with the hiring of a new Chief Commercial Officer and that should get us in a position where we're ready to see sales inside and outside of BARDA in late 2026.

我們持續有計畫擴編銷售團隊。我希望能配合聘任新的首席商務長（Chief Commercial Officer）一併推進，這應該能讓我們在 2026 年底做好準備，看到 BARDA 內外的銷售進展。

And just to be clear, let's assume that the approval comes on time, the 30 systems that are distributed to burn centers around the U.S. How do you think about the commercial activity that is generated from that? Because if you're not necessarily selling those systems, maybe because, again, BARDA's streaming them. Just how do you think about kind of what that does to the business model? Or how should investors think about that over time?

另外，為了釐清一點，假設核准如期到來，那 30 套系統會分配到全美各地的燒傷中心。你如何看待由此帶來的商業活動？因為如果你們不一定是在銷售那些系統，可能是因為（再次強調）BARDA 在提供/配置它們。你怎麼看這對商業模式的影響？投資人應該如何隨時間推移來理解這件事？

We're -- well, so ultimately, each health system will make its own determination on really how they want to treat the device, if we can install it into their facilities, right? Whether it's purchase or lease, it's a different -- it's different from us. It's a different revenue recognition from a company perspective, but we foresee an opportunity for us to be in place with each center that we can place a device at. Hopefully, with a 3-year contract for both improvements in the software, the software licensing and then the delivery of the device maintenance. So you package that whole thing together.

我們——嗯，最終每個醫療體系都會自行決定他們究竟想如何處理這台設備、我們是否能把它安裝到他們的院內設施中，對吧？不論是購買或租賃，對我們而言是不同的——從公司角度來看，收入認列也會不同。但我們預期有機會在每一家我們能放置設備的中心都能進駐。希望能以 3 年合約的形式，涵蓋軟體改良、軟體授權，以及設備維護的交付，把整套方案打包在一起。

Again, it's going to depend on the health system on how we, as a company, treat that revenue stream, but we think that we're well positioned to see. I don't see that adding a lot to our revenue number for 2026, but that will be obviously significant in 2027. And clearly much so -- much more so in 2028, where you have the layer on of the different -- of all the different levels of installations.

同樣地，這將取決於醫療體系，我們公司會如何處理那條收入來源，但我們認為我們已具備良好條件。我不認為這會在 2026 年為我們的營收數字增加很多，但在 2027 年會很明顯地重要。而且在 2028 年會更是如此——因為你會疊加上不同——所有不同層級的安裝所帶來的貢獻。

Okay. And then with this new BARDA contract, which was great to see, we didn't expect -- we certainly did not expect this kind of guidance, which is great, again, very positive to see for 2026. What kind of things are you going to be working on with this additional money from BARDA to enhance DeepView that allows, like I imagine you have to be speeding up some things, maybe pulling forward some opportunities just given the development revenue that you're getting now as part of this contract. And so what does that do for DeepView for sitting here a year from now looking at some of the capabilities and some of the investments you've made over 2026?

好的。接著談到這份新的 BARDA 合約，很高興看到這個消息；我們原本沒預期——我們確實沒預期會有這樣的指引，這很棒，再次強調，對 2026 年來說非常正面。你們打算用 BARDA 這筆額外資金做哪些工作來強化 DeepView？我想你們必須加速一些事情，或把一些機會提前，因為這份合約現在帶來了開發收入。所以，從現在往後一年來看，到了那時 DeepView 的能力以及你們在 2026 年所做的一些投資，會呈現什麼樣的樣貌？

Yes, I love that question. We have so many things that we see as kind of line of sight. We're going to be doing a label expansion. I think that's probably going to be one of the first things you see where we're going to pick up different areas of the body. We'll look to do a label of expansion.

是的，我很喜歡這個問題。我們有很多事情都已經看得到方向、幾乎是近在眼前。我們會做適應症標示（label）擴增。我想這可能會是你最先看到的事情之一，也就是我們會涵蓋身體的不同部位。我們會著手進行標示擴增。

We're going to do further work on our TBSA, total body surface area, offering to make it better for the doctors, better for the physician assistants, better for the nurses. That is a process that we've worked on significantly to get it to this point and it's part of our FDA submission. But the next iteration of that is going to be much better, and the next iteration after that, if there is one, will be even better.

我們也會在 TBSA（total body surface area，全身體表面積）方案上做進一步工作，讓它對醫師更好用、對醫師助理更好用、對護理師也更好用。這是一個我們投入大量心力、一路做到現在的流程，也是我們 FDA 送件的一部分。但它的下一個版本會好很多；再下一個版本（如果還有的話）會更好。

So add that into improved EHR integration, I mean, at a minimum, we're also working on things that are -- we've heard from other users. We're going to improve the battery. We're going to improve some of the user interfaces. This refinement, I think, is going to make our device even that much more valuable in a burn center.

再加上更好的 EHR 整合，我的意思是，至少我們也在做一些——我們從其他使用者那裡聽到的改進。我們會改善電池續航。我們會改善一些使用者介面。我認為這些精進會讓我們的設備在燒傷中心變得更有價值。

The next question is from Carl Byrnes with Northland Capital Markets.

下一個問題來自 Northland Capital Markets 的 Carl Byrnes。

Congratulations again on the BARDA advance, particularly prior to DeepView's approval here, and also Vince your promotion and your new role, congrats there. But with respect to the 31.7 BARDA advance, I'm wondering if you can kind of tell us a bit how you expect that to hit in '26 and '27. And the same with respect to the $63 million remaining on the contract or thereabouts in terms of filling, I would call them obligations, but the buckets there over fiscal '26, '27 and '28. I know that's a lot. But any sort of visibility you can give would be awesome.

再次恭喜 BARDA 的提前撥款，尤其是在 DeepView 尚未獲批之前就拿到，另外也恭喜 Vince 升職、擔任新職務。但就 3,170 萬美元的 BARDA 提前撥款而言，我想請你談談你預期它會如何在 2026 年與 2027 年反映出來。同樣地，關於合約剩餘約 6,300 萬美元的部分，就我所稱的履約——我會稱之為義務，但也就是那些資金桶（buckets）——在 2026、2027、2028 財年之間的分配/填補情況。問題很多，但你能提供任何可見度都會非常棒。

Well, I think we're clearly pleased that BARDA was able to accelerate the second phase of the contract for us in advance of FDA approval. They've been a valued and frankly, a very supportive partner for us. This does a number of things for us. It's going to open up the opportunity for us to really begin in -- if we can gain FDA approval to really begin to start manufacturing devices with the new de novo system in place, really started in earnest with hospital systems for the placement of these devices, and that's part of the contract acceleration. I can't get into too many weeds on the terms of the contract as to what it will do in 2028.

嗯，我想我們顯然很高興 BARDA 能在 FDA 核准之前，為我們加速合約的第二階段。他們一直是我們珍視、坦白說也非常支持我們的合作夥伴。這對我們有多方面的幫助。如果我們能取得 FDA 核准，這將為我們開啟機會，讓我們能真正開始——用新的 de novo 系統到位後，開始製造設備；也能真正開始與醫療體系認真推進這些設備的布署/放置，而這正是合約加速的一部分。至於合約條款在 2028 年會帶來什麼影響，我不能談得太深入。

But have economic outcome studies that we plan on doing. We have an expanded label work that we're going to do internally for expanding our label on what the indication is for, there's outcome studies that we were going to start in earnest sooner rather than later. All of this is great for us as an acceleration and providing us with getting to the part where we can provide better patient outcomes to burn patients and providing a better alternative so that we can help the health care system be in a position to really treat these patients in a more timely and more efficient manner.

但我們規劃要做經濟結果（economic outcome）研究。我們也會在內部進行擴大標示的工作，以擴增我們標示所涵蓋的適應症範圍；還有一些結果研究，我們會希望盡快、越早越好地正式啟動。這一切對我們而言都很棒，因為它加速了進程，讓我們能更快走到能為燒傷病患帶來更好治療結果的階段，並提供更好的替代方案，協助醫療體系能以更即時、更有效率的方式來治療這些病患。

The next question is from Ram Selvaraju with H.C. Wainwright.

下一個問題來自 H.C. Wainwright 的 Ram Selvaraju。

Just three quick ones. Firstly, can you just remind us of the time frame within which you anticipate the entirety of the BARDA funds to ultimately be disbursed. Secondly, I was wondering how you're looking to approach the fine-tuning or revising of revenue guidance as and when the DeepView system achieves FDA licensure. And then lastly, with respect to the potential optimization of DeepView's value outside of the United States. I was wondering if you could perhaps say a few words on that.

三個簡短問題。第一，能否提醒我們，你們預期 BARDA 資金最終全數撥付的時間範圍是多久？第二，我想了解當 DeepView 系統取得 FDA 許可時，你們打算如何著手微調或修訂營收指引。最後，關於在美國以外地區優化 DeepView 價值的潛力，能否也請你簡單談幾句？

Sure. Happy to do so. Three pretty broad questions, but let's kind of walk through that. The BARDA contract in and of itself, I believe, extends until 2030. But if you take a look at the acceleration that really runs mostly through 2028.

當然，可以。三個問題都很廣，我們逐一說明。BARDA 合約本身，我相信會延續到 2030 年。但如果你看這次加速的部分，主要會一路延伸到 2028 年。

So that contract is going to help us with revenue earlier rather than later. And that's the time line for the entire BARDA contract. Ultimately, as things progress, that timeline may be moved up, but that's the terms of the BARDA contract in and of itself, but you're going to see an acceleration through 2028.

因此，這份合約會讓我們更早而不是更晚取得營收，這就是整份 BARDA 合約的時間軸。最終，隨著事情推進，那個時間軸可能會提前，但就 BARDA 合約本身的條款而言，你會看到一路加速到 2028 年。

Refining and revising our forecast on revenue. As I said to Ryan, some of this is dependent upon health systems and how they want to treat the actual deployment of the device. However, they treat it is going to really impact our revenue recognition. But for us, the installation to burn centers is obviously a pivotal event even if it -- even if the revenue is recognized, say, over a 36-month period. But you layer that on with the software licensing piece that is going to benefit them as we make improvements you're going to see that kind of stacking of installations in '27 and 2028 as we move along the continuum of installations, both in burn centers and EDs and level 1 trauma centers.

精煉並修訂我們對營收的預測。正如我對 Ryan 所說，其中一部分取決於醫療體系以及他們希望如何處理該設備的實際部署方式。無論他們如何處理，都將真正影響我們的營收認列。不過對我們而言，將設備安裝到燒傷中心顯然是一個關鍵事件，即使——即使營收是例如在 36 個月期間內認列。但再加上軟體授權的部分，隨著我們持續改進，這將使他們受益；當我們沿著安裝的連續體推進、在燒傷中心以及急診室（ED）與第一級創傷中心部署時，你會看到在 2027 年與 2028 年出現那種安裝量的堆疊。

And that's within and without BARDA. And I'd like to make that point pretty clear. I mean we look to commercialize this in the United States with BARDA's assistance, but not solely exclusively through BARDA's assistance. And that's the same thing with respect to our U.K., our GCC and our Australian international sale opportunities, we're going to modify our U.K. CA authorization to expand it to what is in the current DeepView system that's under de novo review with the FDA.

而這包含 BARDA 之內與之外。我想把這點講得很清楚。我們確實希望在 BARDA 的協助下於美國推動商業化，但並非僅且完全依賴 BARDA 的協助。至於我們在英國、GCC 與澳洲的國際銷售機會也是同樣的情況；我們將修改英國的 CA 授權，將其擴展至目前正在接受 FDA de novo 審查的現行 DeepView 系統所涵蓋的內容。

And at that point, then we will pivot and look to deploy those devices overseas. And that revenue model may be different, as those health systems and some of them are nationalized and how they wish to treat the sale of the DeepView systems abroad. Again, I put little stock in those numbers for 2026, they may be larger, but you'll see more of that as a larger component of revenue clearly in 2027 and in 2028.

到那個時點，我們就會轉向並著手在海外部署這些設備。而營收模式可能會不同，因為那些醫療體系——其中一些是國家化體系——以及他們希望如何處理 DeepView 系統在海外的銷售。再次強調，我對 2026 年的那些數字不太看重，它們可能更大，但你會在 2027 年與 2028 年更清楚看到海外作為營收更大組成部分的貢獻。

The next question is from John Vandermosten with Zacks.

下一個問題來自 Zacks 的 John Vandermosten。

Vince, what does the training force look like? And how will you go about training the trainers for this? Because I assume you're going to have a group go out and get everybody up to speed on how to use them when you do the implementations.

Vince，訓練團隊的規模會是什麼樣子？你們將如何訓練訓練者（train the trainers）？因為我假設在你們進行導入時，會有一個團隊出去讓所有人都熟悉如何使用。

John, good to hear from you. We have a group, fairly decent staff of BMEs currently in place here. And we're going to expand there. We have that in the budget for 2026 on expanding both our sales reps and our biomedical engineers here at Spectral. And it's going to be kind of -- it's going to be in concert with both the BMEs and our sales force to make sure we get out there and train many of these centers when they take the device, how to use it.

John，很高興聽到你的聲音。我們目前已在這裡配置了一個相當不錯的生醫工程師（BME）團隊。我們也會擴編。我們在 2026 年的預算中已納入擴增 Spectral 的銷售代表與生醫工程師人力。這將會——將會由 BME 與我們的銷售團隊協同合作，確保當許多中心接收設備時，我們能到現場訓練他們如何使用。

The device -- and I know you've seen it, but I'm just going to say it for others that haven't, it's intuitive. And so we have a Q4 to make sure that the image capture is the right distance. And we're working on a number of different additional features to it to make it even more user-friendly.

這個設備——我知道你看過，但我還是要對其他沒看過的人說——它很直覺。因此我們在第四季（Q4）要確保影像擷取的距離正確。我們也正在開發多項額外功能，讓它更易於使用。

So yes, we're going to need to expand our training force. We plan on that. We plan on expanding our sales force. I'm just excited about where the company ended in 2025. Our cash number is significant. I think, we're in the best financial position we've ever been in, especially during my tenure here, which is now into my fifth year. And so I'm excited with what we have and where we're going, and we'll marry our training force to meet the expansion of where we're going.

所以是的，我們需要擴編訓練團隊，我們有這個規劃。我們也計畫擴編銷售團隊。我對公司在 2025 年的收官狀況感到振奮。我們的現金水位相當可觀。我認為我們處於有史以來最佳的財務狀況，尤其是在我任內——現在已進入第五年——更是如此。因此我對我們目前擁有的資源與未來方向感到興奮，我們也會讓訓練團隊的配置與我們的擴張步伐相匹配。

And do you have a number in mind in terms of how many individuals that might be for to train?

那你心中有沒有一個大概的數字，可能需要多少人來做訓練？

I don't. I mean I have an estimate in my head. We're talking we're talking -- we're not talking hundreds. We're talking a much smaller number than that. But I'm pleased that we're working in concert with Deloitte Consulting to make sure that we have the right path forward.

我沒有。我是說，我腦中有個估算。我們談的是——我們談的不是幾百人，而是遠小於那個數字。不過我很高興我們正與 Deloitte Consulting 協同合作，確保我們有正確的前進路徑。

Okay. And how much time after clearance do you think you'll need to place the first units.

好的。那你認為在獲得核准後，需要多久才能放置第一批設備？

John, I wish I had a crystal ball, right? All I know is it's going to take us a little while to manufacture the devices. But my hope, and as we've said this before, my hope is that we place devices in late 2026 and you'll see a significant pivot in 2027.

John，我希望我有水晶球，對吧？我只知道我們需要一些時間來製造這些設備。但我的希望——而且我們之前也說過——我的希望是我們在 2026 年底開始放置設備，並且你會在 2027 年看到顯著的轉折。

And last question is just on looking forward in terms of the allocation of R&D spend. I know you've got snapshot. There are some indications outside of burn. And then also, you've talked about the future evolution of the DeepView cart. And then perhaps, I guess, development of AI technology or just the AI ML side of things, how do you see that breaking down going over the next year, 2027, perhaps and beyond in terms of that R&D spend.

最後一個問題是關於未來研發支出的配置。我知道你們有 snapshot。除了燒傷之外還有一些適應症的跡象。另外你也談到 DeepView 推車的未來演進。再者，或許還包括 AI 技術的開發，或只是 AI/ML 這一塊；你如何看待未來一年、到 2027 年甚至更往後，研發支出在這些項目之間會如何拆分？

Well, I will tell you that we're definitely going to do a label expansion with head hands and feet. I mean that's definitely going to be there. we look at a different -- a number of different opportunities for us. A number are being presented to us from third parties. I think the lowest paying fruit will be the label expansion to work on that.

嗯，我可以告訴你，我們肯定會做標籤擴展，涵蓋頭部、手部與足部。這肯定會做。我們也在評估——對我們而言有多種不同的機會，其中不少是由第三方提出的。我認為最容易、最先能取得成果的會是推進標籤擴展。

There may be another indication, whether it is critical in ischemia and things related to that, whether it's amputations or whether we partner with, maybe a wound bed - a wound company to check biofilm markers or wound bed preparedness we continue to see that as a near-term additional indication. But look, we're excited on where we ended up 2025. We're excited about BARDA's commitment to us with an additional 30 -- almost $32 million. We're excited to bring this to the burn community and then expanding thereafter.

可能還會有另一個適應症，不論是重症缺血及其相關領域，不論是截肢，或是我們與某家——也許是傷口床（wound bed）——傷口公司合作，去檢測生物膜（biofilm）標記或傷口床準備度；我們持續將其視為短期內可新增的適應症。不過你看，我們對 2025 年的收官成果感到振奮。我們也對 BARDA 對我們的承諾感到振奮，新增了 3,000 萬——接近 3,200 萬美元。我們很期待把這項產品帶給燒傷社群，並在此之後持續擴展。

This concludes our question-and-answer session. I would like to turn the conference back over to Vince Capone for any closing remarks.

問答環節到此結束。我想把電話會議交回給 Vince Capone，請他做結語。

Gary, thanks. In closing, I would like to again thank our investors for their continued support of our company. I'm excited to deliver on our commitment to develop and commercialize our DeepView system, which we believe will significantly improve patient outcomes. With our strong cash position and continued advances in our product development, I am pleased with where we are to date and where we are going in the near future. Thank you all for your attendance and interest in our company.

Gary，謝謝。最後，我想再次感謝投資人持續支持我們公司。我很期待履行我們開發並商業化 DeepView 系統的承諾；我們相信這將顯著改善病患的治療結果。憑藉我們強勁的現金部位以及產品開發的持續進展，我對我們目前的進度與不久的將來要前往的方向感到滿意。感謝各位出席並關注我們公司。

Have a good evening.

祝各位晚安。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

本次電話會議到此結束。感謝各位參加今天的簡報。您現在可以掛線。