Surmodics Inc (SRDX) 2024 Q2 法說會逐字稿

Welcome, everyone, to Surmodics' Second Quarter of Fiscal Year 2024 Earnings Call. Please note that this call is being webcast. The webcast is accessible through Investor Relations section of the Surmodics website at www.surmodics.com, where an audio replay will be archived for future reference. An earnings press release disclosing Surmodics' quarterly and full year results was issued earlier today and is available on the company website as well.

歡迎大家參加 Surmodics 的 2024 財年第二季財報電話會議。請注意，本次電話會議正在進行網路直播。該網路廣播可透過 Surmodics 網站 www.surmodics.com 的投資者關係部分進行訪問，音訊重播將存檔以供將來參考。今天稍早發布了披露 Surmodics 季度和全年業績的收益新聞稿，該新聞稿也可在公司網站上查看。

Before we begin, I would like to remind everyone that remarks in response to your questions on today's call may contain forward-looking statements. These forward-looking statements are covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements regarding Surmodics' future financial and operating results or other statements that are not historical facts.

在開始之前，我想提醒大家，在今天的電話會議上回答大家提問的言論可能包含前瞻性陳述。這些前瞻性陳述受 1995 年《私人證券訴訟改革法案》的安全港條款管轄，包括有關 Surmodics 未來財務和經營業績的陳述或其他非歷史事實的陳述。

Please be advised that actual results could differ materially from those stated or implied by Surmodics' forward-looking statements resulting from certain risks and uncertainties, including those described in the company's SEC filings. Surmodics disclaims any duty to update or revise these forward-looking statements as a result of new information, future events, developments or otherwise. This call will also include references to non-GAAP measures because Surmodics believes they provide useful information for investors.

請注意，由於某些風險和不確定性（包括該公司向 SEC 文件中描述的風險和不確定性），實際結果可能與 Surmodics 前瞻性陳述中明示或暗示的結果有重大差異。 Surmodics 不承擔因新資訊、未來事件、事態發展或其他原因而更新或修改這些前瞻性聲明的義務。這次電話會議也將提及非公認會計原則措施，因為 Surmodics 認為它們為投資者提供了有用的信息。

Today's earnings release contains reconciliation tables to GAAP results.

今天的收益發布包含 GAAP 結果的調整表。

I would now like to turn the call over to Mr. Gary Maharaj, Surmodics' President and Chief Executive Officer. Please go ahead, sir.

我現在想將電話轉給 Surmodics 總裁兼執行長 Gary Maharaj 先生。請繼續，先生。

Thank you, Kat, and welcome, everyone, to our second quarter fiscal year 2024 earnings call. Let me provide you with a brief overview of what we plan to cover today. I will review our quarterly financial performance at a high level and discuss the operational progress we've made with respect to our key strategic objectives for fiscal 2024. Tim will then walk through our financial results in further detail and review our financial guidance, which we updated in our earnings press release earlier this morning. I'll then share some concluding thoughts on our outlook before opening the call for questions.

謝謝 Kat，歡迎大家參加我們的 2024 財年第二季財報電話會議。讓我向您簡要概述我們今天計劃討論的內容。我將在高水準上回顧我們的季度財務業績，並討論我們在實現2024 財年關鍵戰略目標方面所取得的營運進展。 ，我們今天早上早些時候我們的收益新聞稿中更新了。然後，在開始提問之前，我將分享一些關於我們前景的結論性想法。

With that as a backdrop, let's begin with a review of our quarterly financial results. Our team achieved impressive revenue performance in our second fiscal quarter, culminating in total revenue growth of 18% year-over-year to $32 million. We grew 19%, excluding license fee revenue related to our SurVeil drug-coated balloon, which represented a headwind of approximately 240,000 year-over-year.

以此為背景，讓我們先回顧一下我們的季度財務表現。我們的團隊在第二財季取得了令人印象深刻的營收業績，最終總收入年增 18%，達到 3,200 萬美元。我們成長了 19%，不包括與 SurVeil 藥物塗層氣球相關的許可費收入，這代表著同比約 24 萬的逆風。

Our team's performance handily exceeded our expectations for the quarter, coming in $2.5 million above the range of expectations that we shared on our last earnings call. Looking at the revenue year-over-year performance of our 2 business segments. Revenue from our in Vitro Diagnostics or IVD segment decreased 5% to $7.1 million, which was consistent with our expectations given the high comparable of the prior year quarter. Our revenue growth in the second quarter was exclusively driven by the Medical Device segment revenue, which increased 26% to $24.8 million and 29% excluding the headwind I mentioned related to the SurVeil DCB license fee revenue.

我們團隊的業績輕鬆超出了我們對本季的預期，比我們在上次財報電話會議上分享的預期範圍高出 250 萬美元。看看我們兩個業務部門的營收年增。我們的體外診斷或 IVD 部門的收入下降 5% 至 710 萬美元，考慮到去年同期的高可比性，這與我們的預期一致。我們第二季的營收成長完全由醫療設備部門營收推動，該部門營收成長了 26%，達到 2,480 萬美元，排除我提到的與 SurVeil DCB 授權費收入相關的不利因素，成長了 29%。

Within our Medical Device segment, our year-over-year performance was fueled primarily by product sales, which increased by 40% year-over-year generating $3.2 million of growth. I'm pleased to report that nearly all of the $3.2 million in medical device product sales growth was driven by sales of our Vascular Interventions portfolio, which includes our SurVeil DCB, Pounce thrombectomy and Sublime radial access products. We were pleased with the performance of each of these 3 product platforms that I'll discuss in detail later.

在我們的醫療器材領域，我們的年比業績主要由產品銷售推動，年增 40%，實現 320 萬美元的成長。我很高興地報告，幾乎所有 320 萬美元的醫療器材產品銷售成長都是由我們的血管介入產品組合的銷售推動的，其中包括我們的 SurVeil DCB、Pounce 血栓切除術和 Sublime 橈動脈通路產品。我們對這 3 個產品平台的性能都很滿意，我將在稍後詳細討論。

We also saw impressive contributions from royalties and license fee revenue related to our medical device performance coatings, which increased 27% year-over-year, generating $2.2 million of growth driven in part by a $1.4 million in catch-up payments reported to us by our customers. Importantly, both of these areas of our Medical Device segment exceeded our expectations driving the $2.5 million of total revenue outperformance that we saw relative to our stated range of expectations for the quarter.

我們也看到與我們的醫療器材高性能塗料相關的特許權使用費和許可費收入的貢獻令人印象深刻，同比增長 27%，產生 220 萬美元的增長，部分原因是由我們的客戶。重要的是，我們醫療器材部門的這兩個領域都超出了我們的預期，推動總收入達到 250 萬美元，超出了我們對本季規定的預期範圍。

In addition to our strong revenue performance, we achieved notable year-over-year improvements in our profitability profile, including an $8 million improvement from a GAAP net loss to GAAP net income and a $6.3 million increase in our adjusted EBITDA. And we generated significantly $7.4 million in cash flow from operations in the quarter to further strengthen our balance sheet. Our cash flow performance exceeded our expectations this quarter, driven in part by the royalty catch-up payments I just mentioned as well as a $3.4 million cash tax refund that we secured from the IRS during the second quarter, which Tim will discuss. All in all, we were quite pleased with our second quarter financial results across the Board.

除了強勁的營收表現外，我們的獲利能力也取得了顯著的年比改善，包括從 GAAP 淨虧損變為 GAAP 淨利潤 800 萬美元，調整後 EBITDA 增加 630 萬美元。本季我們從營運中產生了 740 萬美元的現金流，進一步強化了我們的資產負債表。本季我們的現金流表現超出了我們的預期，部分原因是我剛才提到的特許權使用費追繳，以及我們在第二季度從國稅局獲得的340 萬美元現金退稅，蒂姆將討論這一點。總而言之，我們對第二季的整體財務表現非常滿意。

Shifting to a discussion of our recent operational performance. I'm excited to report that our team's achievements in recent months enabled us to deliver strong progress with respect to each of our 3 stated strategic objectives for fiscal '24. Let's begin with our first objective. To capitalize on the key near-term growth catalysts in our vascular interventions portfolio. By facilitating the adoption and utilization of our SurVeil DCB, Pounce thrombectomy and Sublime radial access products. Our success with respect to this initiative is reflected in part by the strong product revenue growth in the Medical Device segment.

轉向討論我們最近的營運績效。我很高興地向大家報告，我們團隊最近幾個月的成就使我們能夠在 24 財年的 3 個既定策略目標方面取得強勁進展。讓我們從第一個目標開始。利用我們血管幹預產品組合中的關鍵近期增長催化劑。透過促進我們的 SurVeil DCB、Pounce 血栓切除術和 Sublime 徑向通路產品的採用和利用。我們在這項措施方面的成功部分反映在醫療器材領域產品收入的強勁成長。

As I mentioned earlier, growth in sales of these products fueled the 40% increase in product revenue and accounted for nearly all of the $3.2 million of product sales growth in the segment. Most notably, we saw consistent demand for our SurVeil drug-coated balloon from our commercial partner, Abbott, following the initial stocking order placed in our fiscal first quarter. As we shared on our last earnings call, we were pleased to see Abbott initiate the commercialization of our SurVeil DCB in late January. As (inaudible) has progressed through the initial months of commercialization, we have been focused on satisfying their demand for product and providing technical information to support their sales, marketing and clinical training activities.

正如我之前提到的，這些產品的銷售成長推動了產品收入成長 40%，並且幾乎佔該細分市場 320 萬美元產品銷售成長的全部。最值得注意的是，繼第一財季的初始庫存訂單之後，我們的商業合作夥伴 Abbott 看到對 SurVeil 藥物塗層氣球的持續需求。正如我們在上次財報電話會議上分享的那樣，我們很高興看到 Abbott 在 1 月底啟動了 SurVeil DCB 的商業化。隨著（聽不清楚）商業化最初幾個月的進展，我們致力於滿足他們對產品的需求並提供技術資訊以支援他們的銷售、行銷和臨床培訓活動。

Since the fulfillment of the initial SurVeil stocking order during the first quarter, we have received orders and updated forecasts from Abbott on a monthly basis, and our team has been continuously building and shipping products to meet these monthly orders. From a manufacturing standpoint, I'm pleased with our successful transition to a steady state of operations following the initial stocking order. As I've said before, drug portable is some of the most difficult interventional devices to make in the industry, and we take pride in our ability to efficiently manufacture the SurVeil DCB to an exacting standard.

自從第一季履行初始 SurVeil 庫存訂單以來，我們每月收到雅培的訂單和更新的預測，我們的團隊一直在不斷建立和運輸產品以滿足這些每月訂單。從製造的角度來看，我很高興我們在最初的庫存訂單之後成功過渡到穩定的營運狀態。正如我之前所說，便攜式藥物是業界最難製造的介入設備之一，我們對能夠按照嚴格標準高效製造 SurVeil DCB 感到自豪。

While our commercial partner remains in the first few months of commercialization, the initial feedback garnered from physician users has been positive. Based on this feedback, we believe SurVeil's ability to achieve uniform targeted transfer and retention of paclitaxel at the treatment area with a highly deliverable balloon platform and ultimately achieved clinical outcomes consistent with the market-leading IN.PACT Admiral device which carries a 75% higher drug load of the cytotoxic drug.

雖然我們的商業合作夥伴仍處於商業化的最初幾個月，但從醫生用戶那裡獲得的初步回饋是正面的。基於此回饋，我們相信SurVeil 能夠透過高度可輸送的球囊平台在治療區域實現紫杉醇的均勻靶向轉移和保留，並最終實現與市場領先的IN.PACT Admiral 裝置一致的臨床結果，該裝置的性能提高了75%細胞毒性藥物的藥物負載。

This represents a compelling clinical advantage for physicians seeking to optimize treatment of peripheral artery disease. Our TRANSCEND randomized controlled trial, which demonstrated excellent safety and effectiveness of our SurVeil DCB at 12, 24 and 36 months post procedure represents important clinical evidence for the Abbott team that can leverage these to articulate the compelling advantages while engaging potential physician users.

對於尋求優化週邊動脈疾病治療的醫生來說，這代表了引人注目的臨床優勢。我們的TRANSCEND 隨機對照試驗證明了SurVeil DCB 在術後12、24 和36 個月時具有出色的安全性和有效性，為Abbott 團隊提供了重要的臨床證據，雅培團隊可以利用這些證據來闡明其引人注目的優勢，同時吸引潛在的醫生用戶。

We look forward to Abbott's continued efforts in the market as they work to facilitate adoption of the SurVeil DCB by raising awareness among key accounts, education and navigating the approval and contracting process associated (inaudible). Aside from the strong demand for our SurVeil DCB from our commercial partner, direct sales of our Pounce thrombectomy products were the most important driver of the 40% or $3.2 million of product sales growth we achieved in the Medical Device segment in the second quarter.

我們期待 Abbott 在市場上繼續努力，透過提高關鍵客戶的意識、教育以及引導相關審批和簽約流程（聽不清楚）來促進 SurVeil DCB 的採用。除了我們的商業合作夥伴對 SurVeil DCB 的強勁需求外，我們的 Pounce 血栓切除術產品的直接銷售是第二季度我們在醫療器材領域實現 40% 或 320 萬美元產品銷售成長的最重要推動力。

The size of our direct sales team has remained consistent throughout the first half of the year with 23 territory managers at the end of the second quarter. As a result of our team's efforts to develop existing accounts expand our active customer base, our Pounce thrombectomy and Sublime radial access products both continue to gain traction in the marketplace. Sales of both products exceeded our expectations during the quarter, driven by strong commercial uptake from new and existing customers.

我們的直銷團隊規模在上半年保持穩定，截至第二季末有 23 位區域經理。由於我們團隊努力開發現有客戶，擴大了我們的活躍客戶群，我們的 Pounce 血栓切除術和 Sublime 徑向通路產品都繼續在市場上獲得關注。在新舊客戶強勁的商業需求推動下，本季這兩種產品的銷售量超出了我們的預期。

Specifically, we saw strong growth in both of our active customer base and in the average revenue per existing customer. In addition, we also saw contributions from our new products, which I'll discuss now. In addition to driving adoption and utilization of our existing Pounce and Sublime products, our team continued to advance the limited market valuations for new additions to our vascular interventions portfolio, including both Pounce Venous for the venous vasculature and Pounce Low Profile for the arterial vasculature. These efforts enable us to achieve considerable progress with respect to our second strategic objective for fiscal '24, which is to facilitate our long-term growth by developing and introducing new products and line extensions to enhance our existing Pounce, Sublime and medical device performance coatings portfolio. Let's begin with an update on Pounce Venous.

具體來說，我們的活躍客戶群和每個現有客戶的平均收入都出現了強勁成長。此外，我們還看到了我們的新產品的貢獻，我現在將討論這一點。除了推動現有Pounce 和Sublime 產品的採用和利用外，我們的團隊還繼續提高血管幹預產品組合新產品的有限市場估值，包括用於靜脈脈管系統的Pounce Venous 和用於動脈脈管系統的Pounce Low Profile。這些努力使我們能夠在24 財年的第二個策略目標方面取得重大進展，即透過開發和推出新產品和產品線擴展來增強我們現有的Pounce、Sublime 和醫療設備性能塗料，從而促進我們的長期增長資料夾。讓我們從 Pounce Venous 的更新開始。

During our second quarter, we completed our limited market evaluation or LME for the Pounce Venous device. Pounce Venus is a 10-French mechanical thrombectomy system designed for mechanical declotting in the peripheral vasculature without the need for capital equipment. During the LME, we were able to evaluate clinical performance in over 75 venous procedures, representing a considerable variety of clinical cases across a broad range of clot morphologies with a large number of physician operators. Pounce Venous has been used throughout the peripheral anatomy ranging from iliac, iliofemoral, femoral popliteal, and subclavian veins. The devices low profile has enabled flexibility in access sites ranging from popliteal, internal jugular brachial veins to as far as the patient's calf.

在第二季度，我們完成了 Pounce Venous 設備的有限市場評估或 LME。 Pounce Venus 是一款 10-French 機械血栓切除系統，設計用於在外周脈管系統中進行機械解凝，無需固定設備。在 LME 期間，我們能夠評估超過 75 個靜脈手術的臨床表現，這些手術代表了大量醫師操作員提供的大量涉及廣泛血栓形態的臨床病例。 Pounce Venous 已用於整個周圍解剖結構，包括髂靜脈、髂股靜脈、股膕靜脈和鎖骨下靜脈。此設備外型小巧，可靈活進入從膕窩、頸內臂靜脈到患者小腿的接入部位。

Clinically, the dual action design of Pounce Venous has shown the ability to remove large volumes of acute and subacute thrombus via its Archimedes Screw technology while the device basket is designed to remove chronic clot. Physician feedback has been invaluable as we work to better understand a broad array of clinical user and product dynamics. Our LME physician users have highlighted some key differentiating features, which make this product unique in the venous thrombectomy space. For example, the device's dynamically adjustable basket automatically adapts to changes in vessel size while applying consistent radial force even within smaller vessels.

臨床上，Pounce Venous 的雙重作用設計顯示出能夠透過阿基米德螺旋技術去除大量急性和亞急性血栓，而裝置籃則設計用於去除慢性血栓。當我們努力更了解廣泛的臨床使用者和產品動態時，醫生的回饋非常寶貴。我們的 LME 醫師使用者強調了一些關鍵的差異化特徵，這些特徵使該產品在靜脈血栓切除術領域中獨一無二。例如，該裝置的動態可調籃子可自動適應容器尺寸的變化，同時即使在較小的容器內也能施加一致的徑向力。

Given the goal of minimizing vessel trauma, physicians have appreciated the ability to expand and retract the basket to spot treat only the areas of need versus repeatedly dragging a mechanical device through the entire vasculature between every pass. Pounce can be resheated, readvanced and deployed within the Clark region if the physician decides and the basket is retracted during removal in non-target treatment zones.

考慮到最大限度地減少血管創傷的目標，醫生們已經意識到能夠擴展和縮回籃子以僅對需要的區域進行定點治療，而不是在每次通過之間重複拖動機械裝置穿過整個脈管系統。如果醫生決定，Pounce 可以在克拉克區域內重新加熱、重新推進和部署，並且在非目標治療區域移除時籃子會縮回。

In addition to this positive feedback on March 4th, we are pleased to see the publication of a multicenter study in the Journal of Vascular Surgery by Dr. Stephen Black at AL, which evaluated the safety and performance of Pounce Venous in 19 patients with acute iliofemoral deep vein thrombosis. The study met its primary endpoint of complete or near complete thrombus removal achieved in all patients with a median treatment time of 23 minutes. All safety endpoints were achieved as well with no major bleeding nor device-related events.

In addition to this positive feedback on March 4th, we are pleased to see the publication of a multicenter study in the Journal of Vascular Surgery by Dr. Stephen Black at AL, which evaluated the safety and performance of Pounce Venous in 19 patients with acute iliofemoral深層靜脈栓塞.該研究達到了主要終點，即所有患者的血栓全部或接近完全清除，中位數治療時間為 23 分鐘。所有安全終點均已實現，沒有發生大出血或設備相關事件。

Based on these findings, the research has concluded that Pounce Venus is both safe and effective for the removal of thrombus in patients with acute iliofemoral deep vein thrombosis. While our FDA 510(k) clearance for Pounce Venous currently does not include a specific clinical indication for the treatment of deep vein thrombosis, we are pleased to see the results of this study.

基於這些發現，研究得出結論，Pounce Venus 對於急性髂股深部靜脈血栓患者的血栓清除既安全又有效。雖然我們對 Pounce Venous 的 FDA 510(k) 許可目前不包括治療深部靜脈血栓形成的具體臨床適應症，但我們很高興看到這項研究的結果。

More broadly, the study in our LME further demonstrated Pounce Venous is safe and effective for removing a variety of different types of thrombus, including chronic clots in a single treatment session, one that can enable physicians to enhance the efficiency and vesatility while minimizing vessel trauma during use.

更廣泛地說，我們LME 的研究進一步證明Pounce Venous 可以安全有效地去除各種不同類型的血栓，包括單次治療中的慢性血栓，這可以使醫生提高效率和靈活性，同時最大限度地減少血管創傷使用過程中。

The devices low-profile dual action technology, combined with the physician controllable basket, ease of use and incredibly low learning curve are likely to be key drivers of product adoption. Like the rest of the Pounce Thrombectomy platform, Pounce Venous also provides additional compelling advantages for physician, and that requires no capital equipment and helps to minimize the need for overnight thrombolytic therapy. On the heels of this important progress, we are excited to announce in our earnings release this morning, the Pounce Venous has now transitioned to a full commercial launch in March.

該設備低調的雙作用技術，結合醫生可控制的籃子、易用性和極低的學習曲線可能是產品採用的關鍵驅動因素。與 Pounce 血栓切除術平台的其他產品一樣，Pounce Venous 也為醫生提供了額外的引人注目的優勢，並且不需要固定設備，有助於最大限度地減少隔夜溶栓治療的需要。繼這一重要進展之後，我們很高興在今天早上的財報中宣布，Pounce Venous 現已過渡到 3 月的全面商業發布。

Given the attractive features and advantages I just outlined, our team is energized and ready to bring this new treatment option to our physician customers, providing with the new tools to enhance the capabilities and outcomes for these patients. Tuning to a Pounce Low Profile Thrombectomy System. As a reminder, Pounce Low Profile or LP features the same mechanism of action as our original Pounce Mid Profile Thrombectomy System. Pounce LP expands the capabilities of our existing offering with a specific clinical indication to treat smaller diameter peripheral arterial vessels, ranging from 2 to 4 millimeters such as those found below the knee.

鑑於我剛才概述的有吸引力的功能和優勢，我們的團隊充滿活力，準備將這種新的治療選擇帶給我們的醫生客戶，並提供新工具來增強這些患者的能力和結果。調整至 Pounce 薄型血栓切除系統。提醒一下，Pounce Low Profile 或 LP 具有與我們原來的 Pounce Mid Profile 血栓切除系統相同的作用機制。 Pounce LP 擴展了我們現有產品的功能，具有特定的臨床適應症，可治療直徑較小的周邊動脈血管，範圍為 2 至 4 毫米，例如膝蓋以下的血管。

On our earnings call in February, I mentioned that the clinical outcomes and feedback from our initial 10 LME cases have been overwhelmingly positive. I'm now pleased to report that the LME continued to surpass our expectations with simply impressive clinical and product performance as we progress through the quarter, and we were equally pleased with the strong positive feedback we obtained. As a reminder, vasculature below the knee tends to be narrow and delicate. Physicians currently have really limited options for removing clot and debris in below-the-knee vessels, which greatly heightens the level of concern for embolic events that can occur during any endovascular procedure.

在 2 月的財報電話會議上，我提到我們最初 10 個 LME 病例的臨床結果和回饋非常正面。我現在很高興地向大家報告，隨著本季度的進展，LME 憑藉令人印象深刻的臨床和產品表現繼續超出我們的預期，我們對獲得的強烈積極反饋也同樣感到滿意。提醒一下，膝蓋以下的脈管系統往往狹窄而脆弱。目前，醫生用於清除膝下血管中的血塊和碎片的選擇非常有限，這大大提高了對任何血管內手術期間可能發生的栓塞事件的關注程度。

While hospitalized treatment likely will include overnight thrombolytic therapy, and it may have some usefulness in treating soft acute clots, it's a costly option. Thrombolytic therapy is also often contraindicated in patients with elevated risk of bleeding. Similarly, the performance of aspiration-based technology is quite limited given that aspiration can be less effective, especially in the smaller diameter harder-to-reach vessels.

雖然住院治療可能包括隔夜溶栓治療，它可能對治療軟急性血栓有一定作用，但這是一種昂貴的選擇。對於出血風險較高的患者，溶栓治療也常常是禁忌的。同樣，基於抽吸的技術的性能也相當有限，因為抽吸效果可能較差，尤其是在直徑較小、難以到達的血管中。

In addition, aspiration technology runs the risk of inadvertently driving costs further down the vessel, further complicating the procedure. The stakes are quite high and vascular interventions often have struggled to address harder, subacute and chronic clots in this area without resorting to open surgery. Performing surgery on tibial arteries is typically quite challenging and often season as an approach to avoid for patients in poor health. With this in mind, a single session on the table and the vascular approach like Pounce LP can completely transform how below the knee and small arterial vessel clot is viewed and treated.

此外，抽吸技術存在無意中進一步降低血管成本的風險，使手術更加複雜。風險相當高，血管介入通常很難在不訴諸開放性手術的情況下解決該區域較硬的、亞急性和慢性的血栓。對脛骨動脈進行手術通常非常具有挑戰性，對於健康狀況不佳的患者來說，通常是一種避免的方法。考慮到這一點，在手術台上進行一次治療和像 Pounce LP 這樣的血管方法可以完全改變膝蓋以下和小動脈血管血栓的觀察和治療方式。

I'd like to repeat that, it can completely transform how below-the-knee vessels are treated. With this as a backdrop, it's difficult to overstate the level of positive feedback to Pounce LP has received from physicians involved in our LME. In contrast to the challenges I just described with expensive overnight thrombolytic therapy, aspiration and open surgery, our early physician users have found that Pounce LP can be deployed past clots all the way down into the ankle with relative ease. Pounce LP's baskets that have expanded and the devices retracted to quickly pull out clots regardless of their morphology restoring fluid to the patient's limb with the entire process taking just a few minutes.

我想重複一遍，它可以徹底改變膝蓋以下血管的治療方式。在此背景下，參與 LME 的醫生對 Pounce LP 的正面回饋程度怎麼強調都不為過。與我剛才描述的昂貴的隔夜溶栓治療、抽吸和開放手術所面臨的挑戰相比，我們的早期醫生用戶發現，Pounce LP 可以相對輕鬆地穿過血栓，一直深入到腳踝。 Pounce LP 的籃子已經展開，設備縮回，可以快速拉出凝塊，無論其形態如何，將液體恢復到患者的肢體，整個過程只需幾分鐘。

In view of the success of these cases and the consistency of the feedback received, I'm excited to announce today that we have also initiated the full commercial Pounce LP, which began in April. We began -- we're looking forward to providing physicians this new nonsurgical solution that fills an important critical gap in existing thrombectomy toolkits.

鑑於這些案例的成功以及收到的回饋的一致性，我今天很高興地宣布，我們也啟動了全面的商業化 Pounce LP，該計劃於 4 月開始。我們開始——我們期待為醫生提供這種新的非手術解決方案，填補現有血栓切除工具包中的一個重要空白。

In addition to this progress with respect to our thrombectomy platform, we continue to be pleased with the market's response to Preside the latest and most advanced hydrophilic coating technology in our Medical Device Performance Coatings business. As we discussed in detail on our last earnings call, Preside hydrophilic coatings impact both industry-leading lubricity and enhanced coating durability to coat the devices. After securing early 510(k) clearances and initiating the commercial launch of Preside hydrophilic coatings during our first quarter, we have seen significant interest from both new and existing customers interested in integrating Preside into their next generation of neurovascular, coronary and peripheral vascular devices.

除了我們的血栓切除平台方面的進展之外，我們繼續對市場對我們醫療器材高性能塗料業務中最新、最先進的親水性塗層技術的反應感到滿意。正如我們在上次財報電話會議上詳細討論的那樣，Preside 親水塗層不僅影響業界領先的潤滑性，還提高了設備塗層的耐用性。在獲得早期510(k) 許可並在第一季啟動Preside 親水塗層的商業推出後，我們看到新舊客戶都對將Preside 整合到下一代神經血管、冠狀動脈和外周血管設備中表現出極大的興趣。

Per our typical process, we are actively working with our customers to conduct feasibility studies for each device and the coating application so they can proceed to securing necessary regulatory approvals. With both our Preside and Serene hydrophilic coatings in the market, we will continue to enhance and strengthen our position as the industry-leading provider of performance coating technologies.

根據我們的典型流程，我們正在積極與客戶合作，對每個設備和塗層應用進行可行性研究，以便他們可以繼續獲得必要的監管批准。憑藉我們在市場上推出的 Preside 和 Serene 親水塗料，我們將繼續增強和鞏固我們作為業界領先的高性能塗料技術提供者的地位。

Lastly, we continue to deliver on our third and final strategic objective by driving durable revenue growth and cash flow generation across our core medical device, Performance Coatings offerings and IVD businesses. Revenue from these 2 areas of our business increased 8% year-over-year on a combined basis. This performance is driven by strong growth in Medical Device Performance Coatings, where we saw a lot of royalty and license fee revenue that exceeded our expectations benefiting from the $1.4 million in catch-up payments reported by our customers and continued growth in customer utilization of our Serene hydrophilic coatings.

最後，我們透過推動核心醫療器材、高性能塗料產品和 IVD 業務的持續收入成長和現金流生成，繼續實現我們的第三個也是最後一個策略目標。我們這兩個業務領域的營收合計年增 8%。這項業績是由醫療器材高性能塗料的強勁成長所推動的，我們看到大量的特許權使用費和許可費收入超出了我們的預期，這得益於我們的客戶報告的140 萬美元的追趕付款以及客戶使用我們的產品的持續成長。

This performance more than offset the performance in our Diagnostics business, where we saw revenue decreased 5% against our largest fiscal quarter of 2023 driven primarily by lower sales of substrate products. As I mentioned earlier, the performance of IVD business was consistent with our expectations for the quarter. The incremental revenue generated by these 2 core business on a combined basis yielded significant contributions to our adjusted EBITDA growth on a year-over-year basis enhancing our profitability profile.

這一業績遠遠抵消了我們診斷業務的業績，我們的診斷業務收入比 2023 年最大的財政季度下降了 5%，這主要是由於基質產品銷量下降所致。正如我之前提到的，IVD 業務的表現與我們對本季的預期一致。這兩個核心業務產生的增量收入對我們調整後的 EBITDA 年成長做出了重大貢獻，增強了我們的獲利能力。

So stepping back. We're quite proud of our recent piece of execution in fiscal 2024. And this has translated to strong financial performance in the first half of the year and meaningful progress with respect to all of our stated objectives. Looking at our year-over-year results in the first half of our fiscal year, our team's execution has enabled us to achieve product sales growth of 41% in our Medical Device segment.

於是退了一步。我們對 2024 財年最近的執行情況感到非常自豪。從我們上半財年的年比業績來看，我們團隊的執行力使我們在醫療器材領域實現了41%的產品銷售成長。

In combination with the strong contribution from our core businesses, this performance accelerated our total revenue growth to 20% on a year-over-year basis in the first half of fiscal '24, 22% growth excluding the SurVeil licensee revenue. In combination with our continued focus on controlling our expenses, our strong revenue performance enabled us to achieve significant year-over-year enhancements to our profitability profile. In the first half of fiscal 2024, we will essentially breakeven on a GAAP net income basis. We generated $8.7 million of adjusted EBITDA and reported $1.4 million in cash used in operating activities.

結合我們核心業務的強勁貢獻，這一業績使我們 2024 財年上半年的總收入同比增長 20%，其中不包括 SurVeil 被許可人收入的增長為 22%。結合我們對控制開支的持續關注，我們強勁的收入表現使我們的獲利能力逐年顯著提高。 2024 財年上半年，以 GAAP 淨利計算，我們將基本達到損益平衡。我們產生了 870 萬美元的調整後 EBITDA，並報告經營活動使用的現金為 140 萬美元。

With $41 million in cash and investments on our balance sheet and access to approximately $65 million of additional debt capital at quarter end, we are well capitalized to support our operations and future growth objectives.

我們的資產負債表上有 4,100 萬美元的現金和投資，並在季度末獲得約 6,500 萬美元的額外債務資本，我們擁有充足的資本來支持我們的營運和未來的成長目標。

Lastly, let me thank every Surmodics' team member for what you have made possible in the first half of this fiscal year. The commercialization of 4 new products to date, our SurVeil DCB, Pounce Venous, Pounce LP, and our Preside coating. It is your dedication, perseverance and belief that makes a difference in lives of patients with the commercial availability of these innovative devices and technologies.

最後，讓我感謝每一位 Surmodics 團隊成員在本財年上半年所做的一切。迄今為止，我們已實現 4 種新產品的商業化：我們的 SurVeil DCB、Pounce Venous、Pounce LP 和我們的 Preside 塗層。正是您的奉獻、毅力和信念使這些創新設備和技術的商業化改變了患者的生活。

We look forward to capitalizing on these important growth catalysts as we tap the significant incremental cost opportunity that they collectively address.

我們期待利用這些重要的成長催化劑，利用它們共同解決的重大增量成本機會。

With that said, I'll turn it over to Tim. I know you've been excited to wait for what Tim has to say here. He will discuss our second quarter financial results and fiscal '24 guidance in detail. Tim?

話雖如此，我會把它交給提姆。我知道您很高興等待蒂姆在這裡說的話。他將詳細討論我們第二季的財務表現和 24 財年指引。提姆？

Thank you, Gary. Unless noted, all references to second quarter results are on a GAAP and year-over-year basis. Total revenue for the second quarter of fiscal 2024 increased $4.8 million or 18% to $32 million. Excluding SurVeil DCB license fee revenue, total revenue increased $5 million or 19% to $30.9 million. Our earnings press release includes detailed reconciliations of total revenue, excluding SurVeil DCB license fee revenue. Product revenue increased $2.7 million or 18% to $18.1 million. Medical Device product revenue increased $3.2 million or 40% to $11.1 million, the second consecutive quarter of 40% or higher growth in our Medical Device business.

謝謝你，加里。除非另有說明，所有對第二季業績的引用均以公認會計準則和年比計算。 2024 財年第二季總營收增加 480 萬美元，成長 18%，達到 3,200 萬美元。不包括 SurVeil DCB 授權費收入，總收入增加 500 萬美元，即 19%，達到 3,090 萬美元。我們的收益新聞稿包括總收入的詳細調節，不包括 SurVeil DCB 許可費收入。產品收入增加 270 萬美元，即 18%，達到 1,810 萬美元。醫療器材產品收入成長 320 萬美元，即 40%，達到 1,110 萬美元，這是我們的醫療器材業務連續第二個季度實現 40% 或更高的成長。

Medical Device product revenue growth was primarily driven by monthly shipments of our SurVeil drug-coated balloon to Abbott and increased sales of our Pounce Thrombectomy device platform. IVD product revenue decreased $440,000 or 6% to $7 million, primarily driven by lower sales of our substrate products. We were pleased with this performance as the prior year quarter was the highest revenue quarter during fiscal 2023 for our IVD business.

醫療器材產品收入的成長主要得益於每月向 Abbott 發貨的 SurVeil 藥物塗層球囊以及 Pounce 血栓切除術設備平台銷售的成長。 IVD 產品收入減少 44 萬美元或 6% 至 700 萬美元，主要是由於我們的基質產品銷售下降。我們對此業績感到滿意，因為上一季是我們 IVD 業務在 2023 財年收入最高的季度。

Royalty and license fee revenue increased $2 million or 21% to $11.4 million. Performance coating royalty and license fee revenue increased $2.2 million or 27% to $10.3 million. Royalty revenue benefited from $1.4 million in catch-up payments in the normal course of our customers reporting sales-based royalties. Royalty revenue growth was also driven by customer reported royalties in excess of estimated royalty as well as continued growth in customer utilization of our Serene hydrophilic coating.

版稅和授權費收入增加 200 萬美元，即 21%，達到 1,140 萬美元。高性能塗料特許權使用費和許可費收入增加 220 萬美元，即 27%，達到 1,030 萬美元。特許權使用費收入受益於我們的客戶報告基於銷售的特許權使用費的正常過程中的 140 萬美元的追加付款。客戶報告的特許權使用費超過估計的特許權使用費以及客戶對我們的 Serene 親水塗層的使用率持續增長也推動了特許權使用費收入的增長。

SurVeil DCB license fee revenue decreased $240,000 or 18% to $1.1 million, corresponding to the decrease in transient clinical study costs incurred. R&D services revenue was $2.4 million and was consistent with the prior year period.

SurVeil DCB 許可費收入減少了 24 萬美元，即 18%，至 110 萬美元，這與所產生的暫時性臨床研究成本的減少相對應。研發服務收入為 240 萬美元，與去年同期持平。

Moving down the P&L. Product gross margin was 60.8% compared to 62.6% in the prior year period. As we shared last quarter, sales of our near-term growth catalysts, our SurVeil drug-coated balloon, Pounce and Sublime products are increasing as a proportion of total company product sales. These device products are not yet at scale and product gross margins are impacted by the associated under absorption and production inefficiencies.

損益表向下移動。產品毛利率為60.8%，去年同期為62.6%。正如我們在上季度分享的那樣，我們的近期成長催化劑、SurVeil 藥物塗層氣球、Pounce 和 Sublime 產品的銷售額占公司產品總銷售額的比例正在增加。這些設備產品尚未形成規模，產品毛利率受到相關吸收不足和生產效率低下的影響。

R&D expense decreased $2.7 million or 21% to $10.2 million. This was primarily driven by lower SurVeil DCB related costs, the timing of development and commercialization of our thrombectomy devices and the benefits from the spending reduction plan we implemented during the second quarter of fiscal 2023. SG&A expense increased $130,000 or 1% to $13.1 million. Lastly, in the prior year quarter, we reported $1.3 million in severance-related restructuring expense from the workforce restructuring implemented last year.

研發費用減少 270 萬美元，即 21%，至 1,020 萬美元。這主要是由於SurVeil DCB 相關成本降低、血栓切除設備的開發和商業化時機以及我們在2023 財年第二季度實施的支出削減計劃帶來的好處。萬美元。最後，在上一季度，我們報告了去年實施的勞動力重組中與遣散費相關的重組費用為 130 萬美元。

We were pleased to generate GAAP operating income in both our Medical Device and IVD businesses during the quarter. Our Medical Device business reported operating income of $300,000 compared to a loss of $7.1 million in the prior year period, primarily reflecting our strong revenue growth and lower R&D expenses. Two items I discussed earlier, the $1.4 million in royalty revenue catch-up payments recognized this quarter and the $1.3 million restructuring expense in the prior year provided tailwinds to our performance as well.

我們很高興本季我們的醫療器材和 IVD 業務均產生了 GAAP 營業收入。我們的醫療器材業務報告營業收入為 30 萬美元，而去年同期虧損 710 萬美元，主要反映了我們強勁的收入成長和較低的研發費用。我之前討論過的兩個項目，本季確認的 140 萬美元的特許權使用費收入補足付款和上一年的 130 萬美元的重組費用也為我們的業績提供了動力。

Our IVD business reported operating income of $3.4 million or 47% of IVD revenue compared to $3.6 million or 49% of IVD revenue in the prior year period reflecting the decrease in IVD revenue.

我們的 IVD 業務報告營業收入為 340 萬美元，佔 IVD 收入的 47%，而去年同期為 360 萬美元，佔 IVD 收入的 49%，反映出 IVD 收入的下降。

Turning to income taxes. We reported income tax benefit of $80,000 compared to income tax expense of $370,000 in the prior year period. GAAP net income was $250,000 or $0.02 per diluted share compared to a net loss of $7.7 million or a loss of $0.55 per diluted share in the prior year period.

轉向所得稅。我們報告的所得稅優惠為 80,000 美元，而上一年期間的所得稅支出為 370,000 美元。 GAAP 淨利潤為 250,000 美元，即稀釋後每股虧損 0.02 美元，去年同期淨虧損為 770 萬美元，即稀釋後每股虧損 0.55 美元。

Non-GAAP net income was $1.1 million or $0.07 per diluted share compared to a net loss of $5.6 million or a loss of $0.40 per diluted share in the prior year period. Non-GAAP adjusted EBITDA was $4.8 million compared to adjusted EBITDA loss of $1.5 million in the prior year period. Our earnings press release includes detailed reconciliations of GAAP to non-GAAP measures.

非 GAAP 淨利潤為 110 萬美元，即稀釋後每股虧損 0.07 美元，去年同期淨虧損為 560 萬美元，即稀釋後每股虧損 0.40 美元。非 GAAP 調整後 EBITDA 為 480 萬美元，而去年同期調整後 EBITDA 虧損為 150 萬美元。我們的收益新聞稿包括 GAAP 與非 GAAP 指標的詳細調整。

Moving to the balance sheet. During the second quarter, we reported cash provided by operating activities of $7.4 million and capital expenditures of $1.3 million. Cash provided by operating activities in the second quarter benefited from the receipt of a $3.4 million cash tax refund from the IRS associated with the Cares Act employee retention credit which we have discussed in our prior earnings calls and which we were pleased to receive during this period.

轉向資產負債表。第二季度，我們報告經營活動提供的現金為 740 萬美元，資本支出為 130 萬美元。第二季經營活動提供的現金受益於從美國國稅局收到的340 萬美元現金退稅，該退稅與關懷法案員工保留信貸相關，我們在之前的財報電話會議中已經討論過，我們很高興在此期間收到這筆退稅。

We ended the second quarter with $40.9 million in total cash and cash equivalents and investments and available for security investments, an increase of $5.8 million during the quarter. Long-term debt of $29.5 million was unchanged during the quarter. At quarter end, we had access to approximately $65 million in additional borrowing capacity under our existing credit agreement.

在第二季末，我們的現金、現金等價物和投資以及可用於證券投資的總額為 4,090 萬美元，本季增加了 580 萬美元。本季長期債務維持不變，為 2,950 萬美元。截至季末，我們根據現有信貸協議獲得了約 6,500 萬美元的額外借款能力。

Turning now to fiscal 2024 guidance, which we updated in our earnings release today to reflect both our outperformance in the second quarter as well as our improved outlook for the remainder of fiscal 2024. We now expect fiscal 2024 total revenue to range from $122 million to $124 million, representing a decrease of 8% to 6%. Excluding SurVeil DCB license fee revenue, we expect revenue to range from $118 million to $120 million, representing an increase of 15% to 17%. This compares to our prior range of $113 million to $117 million or an increase of 10% to 14% over the prior year.

現在轉向2024 財年指引，我們在今天的收益發布中更新了該指引，以反映我們第二季度的優異表現以及我們對2024 財年剩餘時間的展望的改善。 1.22 億美元到1.22 億美元之間1.24億美元，下降8%至6%。排除 SurVeil DCB 授權費收入，我們預計收入範圍為 1.18 億美元至 1.2 億美元，增幅為 15% 至 17%。相比之下，我們之前的範圍為 1.13 億美元至 1.17 億美元，比前一年增加了 10% 至 14%。

SurVeil DCB license fee revenue is expected to be approximately $4 million in fiscal 2024 compared to $29.6 million in fiscal 2023. We now expect fiscal 2024 GAAP loss per diluted share to range from a loss of $0.90 to a loss of $0.70 compared to our prior range of a loss of $1.40 to a loss of $1.10. Non-GAAP loss per diluted share is expected to range from a loss of $0.67 to $0.47 per share compared to our prior range of a loss of $1.17 to a loss of $0.87 per share.

SurVeil DCB 許可費收入預計在2024 財年約為400 萬美元，而2023 財年為2960 萬美元。的範圍相比損失 1.40 美元到損失 1.10 美元。非公認會計原則每股攤薄虧損預計為每股虧損 0.67 美元至 0.47 美元，而我們先前的每股虧損為 1.17 美元至 0.87 美元。

I'll now share a few additional considerations for modeling purposes. With respect to our fiscal 2024 total revenue guidance, product revenue is expected to be approximately 60% of total revenue, driven largely by contributions from our product growth catalysts. Specifically, we now expect combined product revenue from our SurVeil, Pounce and Sublime products of at least $15.5 million, an increase from the $14 million we communicated last quarter. Revenue associated with our Medical Device performance coating offerings and IVD business is expected to grow in the low to mid-single digits from the $88.3 million of combined revenue generated in fiscal 2023.

現在，我將分享一些出於建模目的的其他注意事項。就我們 2024 財年的總收入指引而言，產品收入預計將佔總收入的 60% 左右，這主要是由我們產品成長催化劑的貢獻所推動的。具體來說，我們現在預計 SurVeil、Pounce 和 Sublime 產品的綜合產品收入至少為 1550 萬美元，高於我們上季度公佈的 1400 萬美元。與我們的醫療器材高性能塗層產品和 IVD 業務相關的收入預計將從 2023 財年產生的 8,830 萬美元的合併收入中低至中個位數成長。

Our fiscal 2024 diluted loss per share guidance reflects the following assumptions for the full fiscal year. Product gross margin is expected to be in the mid- to high 50s, we expect operating expenses, excluding product costs to decrease in the mid-single digits. We expect R&D expense to range from $39.5 million to $40.5 million, representing a decrease of 15% to 13%. We expect SG&A expense to range from $53 million to $54 million, representing an increase of 2% to 4% as we invest in our commercial organization. Interest expense is expected to be approximately $3.5 million, consistent with the prior year.

我們的 2024 財年攤薄每股虧損指引反映了整個財年的以下假設。產品毛利率預計在 50 多歲左右，我們預計不計產品成本的營運費用將下降中個位數。我們預計研發費用將在 3,950 萬美元至 4,050 萬美元之間，下降 15% 至 13%。我們預計 SG&A 費用將在 5,300 萬美元至 5,400 萬美元之間，隨著我們對商業組織的投資，將增加 2% 至 4%。利息支出預計約 350 萬美元，與前一年持平。

Finally, our EPS guidance reflects full year tax expense of $3.5 million to $4.5 million. With respect to our revenue growth in the third quarter, we expect third quarter total revenue to range from approximately $29.5 million to $30.5 million, representing a decrease of approximately 44% to 42%. Excluding SurVeil drug-coated balloon license fee revenue, we expect third quarter revenue to range from $28.5 million to $29.5 million, representing an increase of 7% to 11%. As a reminder, in the third quarter of fiscal 2023, we recognized $25.9 million of SurVeil drug-coated balloon license fee revenue, the majority of which was related to the PMA milestone payment achieved in the period.

最後，我們的 EPS 指引反映了 350 萬至 450 萬美元的全年稅收支出。關於第三季的營收成長，我們預期第三季總營收約為2,950萬美元至3,050萬美元，下降約44%至42%。排除 SurVeil 藥物塗層球囊許可費收入，我們預計第三季收入將在 2,850 萬美元至 2,950 萬美元之間，增幅為 7% 至 11%。提醒一下，在 2023 財年第三季度，我們確認了 2,590 萬美元的 SurVeil 藥物塗層球囊許可費收入，其中大部分與該期間實現的 PMA 里程碑付款有關。

Lastly, with respect to cash utilization. At the end of fiscal 2023, we had $45.4 million of cash and investments, which included $3.9 million of available-for-sale securities. We now expect to finish fiscal 2024 with approximately $35 million to $38 million in cash and investments, representing a year-over-year decrease of $10 million to $7 million. Our updated expectation represents an improvement of $6 million to $7 million compared to the expectation shared on our first quarter earnings call, driven by improved operating performance.

最後，關於現金使用。截至 2023 財年末，我們擁有 4,540 萬美元的現金和投資，其中包括 390 萬美元的可供出售證券。我們現在預計 2024 財年結束時將擁有約 3,500 萬至 3,800 萬美元的現金和投資，年減 1,000 萬至 700 萬美元。由於營運業績改善，我們更新後的預期比第一季財報電話會議的預期提高了 600 萬至 700 萬美元。

As we have discussed in detail on recent earnings calls during fiscal 2023, cash and investments increased $26 million, reflecting an influx of cash from the $27 million milestone payment on receiving PMA for the SurVeil drug-coated balloon as well as $19.3 million in net debt proceeds from our term loan and revolving credit facility. Setting aside these items, cash and investments decreased by approximately $20 million in fiscal 2023. With this in mind, our updated expectations for fiscal 2024 year in cash and investments reflects an improvement in cash use of $10 million to $13 million compared to the $20 million in fiscal 2023 I just mentioned.

正如我們在最近的2023 財年財報電話會議上詳細討論的那樣，現金和投資增加了2600 萬美元，反映出收到SurVeil 藥物塗層氣球PMA 的2700 萬美元里程碑付款以及1930 萬美元的淨債務帶來的現金湧入來自我們的定期貸款和循環信貸額度的收益。撇開這些項目不談，2023 財年現金和投資減少了約2000 萬美元。萬美元。

Our expectations for fiscal 2024 year-end cash and investments continue to reflect the following assumptions. Capital expenditures of up to $5 million compared to $2.9 million in fiscal 2023, which includes certain investments postponed last year as part of our spending reduction plan and payments totaling $2.7 million to satisfy obligations related to previous acquisitions, of which $930,000 was paid during the second quarter.

我們對 2024 財年年底現金和投資的預期繼續反映以下假設。 Capital expenditures of up to $5 million compared to $2.9 million in fiscal 2023, which includes certain investments postponed last year as part of our spending reduction plan and payments totaling $2.7 million to satisfy obligations related to previous acquisitions, of which $930,000 was paid during the second四分之一.

We remain focused on disciplined expense management and optimization of working capital and importantly, our fiscal 2024 guidance continues to assume no borrowings under our credit agreement.

我們仍然專注於嚴格的費用管理和營運資金優化，重要的是，我們的 2024 財年指導繼續假設我們的信貸協議項下沒有借款。

With that, I'll turn the call back to Gary for closing remarks.

之後，我將把電話轉回給加里，讓他作結束語。

Thanks, Tim. As Tim mentioned, we're pleased to reach our financial guidance today for the second time this year, which reflects both our recent outperformance and our increased outlook for the balance of the year. Importantly, I want to emphasize that the low end of our guidance range now calls for total revenue growth of at least 15% year-over-year, excluding the headwinds related to the SurVeil DCB license fee revenue.

謝謝，蒂姆。正如提姆所提到的，我們很高興今天第二次達成我們的財務指引，這不僅反映了我們最近的優異表現，也反映了我們對今年剩餘時間的展望。重要的是，我想強調的是，我們指導範圍的低端現在要求總收入同比增長至少 15%，不包括與 SurVeil DCB 許可費收入相關的不利因素。

We expect this growth to be fueled by revenue from our vascular interventional products of at least $15.5 million compared with our initial expectation of $15.5 million. Looking ahead, our team is energized by our recent success and remains focused on executing our growth strategy to continue our recent momentum as we enter the second half of fiscal 2024. With steady growth and cash flow generation from our core businesses, demonstrated commercial traction from our existing products and an expanded portfolio of innovative vascular interventional devices addressing large and underpenetrated markets, we believe Surmodics is exceptionally well positioned to deliver strong, sustained revenue growth.

我們預計這一增長將由至少 1550 萬美元的血管介入產品收入推動，而我們最初的預期為 1550 萬美元。展望未來，我們的團隊因最近的成功而充滿活力，並繼續專注於執行我們的成長策略，以在進入2024 財年下半年時繼續我們最近的勢頭。的產生，展示了來自憑藉我們現有的產品和擴大的創新血管介入設備產品組合，解決大型且滲透不足的市場問題，我們相信 Surmodics 處於非常有利的地位，能夠實現強勁、持續的收入增長。

By accelerating our growth while continuing to control our expenses, and allocate capital dynamically and strategically, we remain committed to delivering sustained improvements in our underlying profitability profile. Surmodics is focused on delivering value for the benefit of our patients, our customers, our employees and investors. And it's important that you know we have the courage and the commitment to continue to pursue our mission to improve the detection and treatment of disease.

透過加速我們的成長，同時繼續控制我們的費用，並動態和策略性地分配資本，我們仍然致力於持續改善我們的基本獲利狀況。 Surmodics 致力於為患者、客戶、員工和投資者的利益創造價值。重要的是，您知道我們有勇氣和承諾繼續追求我們改善疾病檢測和治療的使命。

I'd like to conclude my prepared remarks today by thanking all of these important stakeholders for their support of our company and our continued pursuit of this mission. We really need more companies like Surmodics.

在結束今天準備好的演講時，我想感謝所有這些重要的利害關係人對我們公司的支持以及我們對這項使命的持續追求。我們確實需要更多像 Surmodics 這樣的公司。

Operator, we will now open the call for questions.

接線員，我們現在開始提問。

(Operator Instructions) Our first question will come from Brooks O'Neil from Lake Street Capital Markets.

（操作員說明）我們的第一個問題將來自 Lake Street Capital Markets 的 Brooks O'Neil。

As usual, you guys operate a very thorough and complete overview. But I think it's offensive that you talk about all this detail, and then you say we can ask 1 question and 1 follow-up, but I'll try my best to stick to your requirements here. So first, I'm just curious, if you could help us to calibrate the TAM for SurVeil today and the second part of question one, could you give us a sense for whether the level of revenue the product is beginning to generate is sufficient to maintain Abbott's long-term interest in this product in this market?

像往常一樣，你們進行了非常徹底和完整的概述。但我認為你談論所有這些細節，然後你說我們可以問 1 個問題和 1 個後續行動，這是令人反感的，但我會盡力在這裡堅持你的要求。首先，我很好奇，如果您今天能幫助我們校準 SurVeil 的 TAM 以及問題一的第二部分，您能否讓我們了解該產品開始產生的收入水平是否足以保持雅培對該產品在該市場的長期興趣？

Yes. Brook, I'll start with the second part there. We -- I don't want to speculate about what Abbott needs, but I can tell you that the partnership is strong, and they're excited about getting going in its very early innings. As far as their portfolio and their strategy and numbers and stuff, I don't have the information to speculate now what I want to. I'll turn over some of the TAM component to Tim here. But think of it -- it's a bit of a dynamic TAM. Since the FDA unwounded the label warning on paclitaxel a year ago, I guess, it was last year.

是的。布魯克，我將從第二部分開始。我們——我不想猜測雅培需要什麼，但我可以告訴你，雙方的合作關係很牢固，他們對在早期階段就開始感到興奮。至於他們的投資組合、策略、數字等，我現在沒有資訊來推測我想要的內容。我將在這裡將一些 TAM 組件移交給 Tim。但想想——它有點像動態 TAM。自從一年前 FDA 取消了紫杉醇的標籤警告以來，我想那是去年。

Every patient who is going to be treated with balloon angioplasty procedure in the periphery, in my opinion, is a candidate for a drug-coated balloon. I mean with so many randomized, I don't know, we have 7 randomized controlled trials culminating with the TRANSCEND trial, which I will say is the best one -- the best ever run trial in this space because it was head-to-head, but really clearly demonstrates the durability and impartment of anti-restenotic drug on a balloon. And that durability, as I said, the data is quite compelling.

在我看來，每位要接受週邊球囊血管成形術治療的患者都是藥物塗層球囊的候選者。我的意思是，有這麼多隨機試驗，我不知道，我們有7 項隨機對照試驗，最終是TRANSCEND 試驗，我會說這是最好的一個——這個領域有史以來最好的試驗，因為它是正面對-頭，但確實清楚地展示了氣球上抗再狹窄藥物的耐久性和傳遞性。正如我所說，這種持久性的數據非常引人注目。

So if you want to prevent restenosis rates on plain old balloon, the mandate should be you always use a drug-coated balloon, not just for difficult lesions. So I would say the TAM is much, much larger than the current market. But I know, Tim, we've been tracking the IMS data and seeing the rebound of the market. So I'll turn that over to Tim.

因此，如果您想防止普通舊球囊的再狹窄率，那麼您應該始終使用藥物塗層球囊，而不僅僅是針對困難的病變。所以我想說 TAM 比目前市場大得多。但我知道，蒂姆，我們一直在追蹤 IMS 數據並看到市場的反彈。所以我會把它交給蒂姆。

That's right. TAM really hasn't changed, Brooks. There's over 500,000 above-the-knee cases that are performed in the U.S. annually. Given kind of the cases leverage multiple balloons, I've heard anywhere from 1.3 north of 1.3 balloons per procedure, you're looking at ASPs from a list perspective that are greater than 1,500, obviously, there's some discounts, but that gets you to about $1 billion TAM. I think 1 of the reasons Abbott was interested in negotiating an agreement for distribution rights back in 2018 was because of the TAM and how they viewed it, as Gary mentioned, a technology that could really provide a lot of benefit to patients that were suffering from peripheral vascular disease.

這是正確的。 TAM 確實沒有改變，布魯克斯。美國每年進行超過 50 萬例膝上手術。考慮到利用多個氣球的情況，我聽說每個程序使用 1.3 個氣球以上 1.3 個以上，您從列表的角度來看 ASP 大於 1,500，顯然，有一些折扣，但這讓您約10 億美元TAM 。我認為雅培在 2018 年有興趣就分銷權談判協議的原因之一是因為 TAM 以及他們如何看待它，正如加里所提到的，這項技術確實可以為患有癌症的患者提供許多好處周圍血管疾病。

But to be clear, it's very early in Abbott's launch. They launched in late January. We're here on May 1. We're 3 months into it. I'll just refer you back to our prepared remarks. Every month, we've been receiving orders from Abbott -- every month Brooks. As Gary mentioned, they've been consistent. We're pleased with the orders. We're manufacturing, we're shifting. We're recognizing revenue. So let's make sure we don't forget to ask the question again next quarter or maybe even the quarter after. But we're pleased with what we're seeing right now.

但要先明確的是，雅培的推出還處於早期階段。他們於一月下旬推出。我們在 5 月 1 日到達這裡。我只想請您回顧一下我們準備好的發言。每個月，我們都會收到雅培（Abbott）的訂單——每個月都有布魯克斯（Brooks）的訂單。正如加里所提到的，他們一直保持一致。我們對訂單很滿意。我們正在製造，我們正在轉變。我們正在確認收入。因此，我們要確保不要忘記在下個季度甚至下個季度再次提出這個問題。但我們對現在所看到的感到滿意。

Just the 1 question, though.

不過，只有第一個問題。

So just as a follow-up, sorted to that related to Abbott, I saw an announcement the other day that they got approval for dissolving drug-coated stent for below-the-knee (inaudible) that they probably put that in, unless they have a catheter to open the vessel a little bit. Are they showing any new or renewed interest in your products that are developed for below the knee?

因此，作為與雅培相關的後續行動，我前幾天看到一則公告，他們獲得了批准溶解膝蓋以下的藥物塗層支架（聽不清楚），他們可能會將其放入，除非他們用導管稍微打開血管。他們是否對您為膝蓋以下開發的產品表現出新的或新的興趣？

We haven't had any discussions with them about that, but the (inaudible) standards by resorbable -- and I believe it specifically got PMA approval this week. It's specifically for below-the-knee vessels. So as far as our Sundance, we have -- we continue to make progress in looking for parties of interest, and we have conversations with multiple parties there. Sundance requires some investment and allocation of capital to get it to an IDE level.

我們還沒有與他們就此進行任何討論，但可吸收的（聽不清楚）標準 - 我相信它本週特別獲得了 PMA 批准。它專門用於膝蓋以下的血管。就我們的聖丹斯電影節而言，我們在尋找感興趣的各方方面繼續取得進展，並且我們與那裡的多方進行了對話。聖丹斯電影節需要一些投資和資金分配才能達到 IDE 等級。

At this point, we would choose not to move much more on that without a partner helping the funding of that. But we are in that...

在這一點上，如果沒有合作夥伴提供資金協助，我們將選擇不再採取更多行動。但我們在那...

Okay. You are in discussions Okay? I'm just going to ask 1 more, which is, obviously, over the past 5 years, R&D spending has been in the range of 50% of revenue. It's been a very productive investment, and it shows tremendous promise. Do you expect to continue spending at that dollar level or that percent of revenue level now that we're, let's say breaking into the clear here?

好的。你們正在討論好嗎？我只想再問一個問題，很明顯，過去5年裡，研發支出一直在收入的50%左右。這是一項非常富有成效的投資，並顯示出巨大的前景。既然我們已經進入了透明狀態，您是否預計會繼續以該美元水平或收入水平的百分比進行支出？

Right. And I'll give you a little bit of the strategy and Tim will follow up with some of the actual hot edges. So if you don't have a pipeline, you have to develop a pipeline, right? And so pipeline stuffing requires, as you know, accelerated R&D investments. Eventually, the pipeline gets into equilibrium. What's going in and what's coming out, generating cash in an equilibrium and those help offset each other.

正確的。我將向您介紹一些策略，蒂姆將跟進一些實際的熱點。所以如果你沒有管道，你就必須開發管道，對嗎？因此，如您所知，管道填充需要加速研發投資。最終，管道達到平衡。進來的和出去的，在均衡中產生現金，並且這些有助於相互抵消。

So the clinical trial costs are coming out. We have multiple year follow-up. We have a couple more years of follow-up in some of them. Revenue is going up, but the level of R&D spending that we are contemplating right now are really A, on the vascular inventions portfolio, making sure the platforms we have, thrombectomy and radial access -- venous and arterial thrombectomy and radial access, that we fill out those platforms with the complete product line so that we could be compellingly -- compelling competitive advantage. That's still in process. We still have Pounce Excel. We still have things like Pounce Over The Wire. We have many things in that pipeline within that box of current platforms.

那麼臨床試驗費用就出來了。我們有多年的追蹤。我們對其中一些還需要幾年的跟進。收入正在上升，但我們現在正在考慮的研發支出水平確實是 A，在血管發明組合上，確保我們擁有的平台、血栓切除術和橈動脈通路——靜脈和動脈血栓切除術和橈動脈通路，我們用完整的產品線填充這些平台，以便我們能夠獲得令人信服的競爭優勢。這仍在進行中。我們仍然有 Pounce Excel。我們仍然有像“Pounce Over The Wire”這樣的東西。我們在當前平台的盒子裡有很多東西。

We also want to make sure on the Performance Coatings business. We have Preside and our teams just a remarkably sounded chemical engineering team of how we further advance that technology. So we can make the game over. I mean, Surmodics is going to lead this field and we're not seeding that leadership advantage in our Performance Coatings business.

我們還想確定高性能塗料業務。我們有主席，我們的團隊是一支非常健全的化學工程團隊，負責我們如何進一步推進這項技術。這樣我們就可以結束遊戲了。我的意思是，Surmodics 將引領這一領域，但我們並沒有在高性能塗料業務中播種這種領先優勢。

Apart from that, Tim, I'll turn it over to you. I would expect some (inaudible).

除此之外，提姆，我會把它交給你。我希望有一些（聽不清楚）。

Thank you, Brooks. We're really pleased that we're starting to see the product revenue grow the way it's been growing as -- as Gary and I have mentioned in the prepared remarks, we're expecting at least $15.5 million of revenue this year, and we keep increasing our guidance every quarter with regard to these products. This is a combination of that -- those investments in R&D over several years.

謝謝你，布魯克斯。我們真的很高興我們開始看到產品收入以這種方式增長——正如加里和我在準備好的發言中提到的那樣，我們預計今年的收入至少為 1550 萬美元，而且我們每個季度不斷增加我們對這些產品的指導。這是多年來對研發的投資的組合。

As you mentioned, 50% of our revenue in the past had been invested in R&D. There's -- clearly, this year, you heard in my remarks in terms of some of the modeling considerations, we're having a lower spend in R&D this fiscal year versus the prior fiscal year, that's really attributable to the R&D spend that had gone into SurVeil and other drug-coated balloon platforms. That's really what the driver is. We've continued to invest, obviously, in some of the vascular intervention products with regard to Pounce and Sublime of which notably we've launched a few and commercialized if you hear just within the last quarter. So I wouldn't drive you or guide you to thinking that we'd get back to 50% of revenue would be spent on R&D.

正如您所提到的，我們過去50%的收入都投入了研發。顯然，今年，你在我的演講中聽到了一些建模方面的考慮，我們本財年的研發支出比上一財年要低，這實際上是因為研發支出已經消失了。塗層氣球平台。這才是真正的司機。顯然，我們繼續投資一些與 Pounce 和 Sublime 相關的血管介入產品，其中值得注意的是，如果您在上個季度聽說過，我們已經推出了一些產品並已商業化。因此，我不會促使您或引導您認為我們將恢復 50% 的收入用於研發。

At least we don't see that in the near and intermediate term by any means. And certainly, as our revenue continues to jump and Brooks, you go back several years ago, we were in the mid-70s in terms of millions of dollars of revenue generated annually, here we are talking about $122 million to $124 million. So there is -- it would be very unlikely that we'd get back to 50%. But we feel very confident that we're making the appropriate level of investments in R&D at this point.

至少我們在近期和中期看不到這種情況。當然，隨著我們的收入持續成長，布魯克斯，你可以追溯到幾年前，就每年產生的數百萬美元的收入而言，我們正處於70 年代中期，這裡我們談論的是1.22 億至1.24 億美元。所以，我們不太可能回到 50%。但我們非常有信心，我們目前正在對研發進行適當水準的投資。

Perfect. That's very helpful. Congratulations on all you've accomplished.

完美的。這非常有幫助。祝賀您所取得的一切成就。

Our next question comes from Mike Matson from Needham & Company.

我們的下一個問題來自 Needham & Company 的 Mike Matson。

This is Joseph on for Mike. Just from us. The 14 -- or I guess, $15.5 million guide for Pounce, SurVeil, Sublime, I was just wondering if we could maybe get a little bit more color on those numbers, not necessarily asking for a split, but if there is any more upside to that, any raises, wondering if you could call out where you think those would come from? Whether it be a specific product? And then I don't know if you said that in the prepared remarks, but the raise today, is that driven by the launches of LP and -- in Pounce LP and Pounce Venous? Or just a little bit more color on that would be great.

這是麥克的約瑟夫。就來自我們。 14——或者我猜，Pounce、SurVeil、Sublime 的 1550 萬美元指南，我只是想知道我們是否可以在這些數字上獲得更多的色彩，不一定要求分割，但是否還有更多的上漲空間對此，任何加薪，想知道你是否可以說出你認為這些加薪來自哪裡？是否為特定產品？然後我不知道你是否在準備好的發言中說過這一點，但今天的加薪是由 LP 的推出以及 Pounce LP 和 Pounce Venous 的推出推動的嗎？或者再加一點顏色就更好了。

Sure. It's a great question, and I'm sure a lot of people are thinking and wanting to ask the same question. So thanks for putting it out there. Yes, I would tell you that our view today on the at least $15.5 million is at least $15.5 million. Justin, let's be really clear on the question with regard to the raise and what's coming -- what's coming from Pounce LP and Pounce Venous, we're very measured on that. It's very early stages. We've completed the limited market evaluations, they went very well. But as you can imagine, we're going to be appropriately conservative in terms of including in our guidance any real significant revenue increases until we validate and get traction. So the $15.5 million, although it does include some revenue from these recent product launches, it's not what's driving it entirely. It's a portion of the increase.

當然。這是一個很好的問題，我相信很多人都在思考並想問同樣的問題。所以謝謝你把它放在那裡。是的，我想告訴你，我們今天對至少 1550 萬美元的看法是至少 1550 萬美元。 Justin，讓我們明確一下有關加薪和即將發生的事情的問題 - Pounce LP 和 Pounce Venous 會帶來什麼，我們對此非常謹慎。現在還處於非常早期的階段。我們已經完成了有限的市場評估，進展非常順利。但正如您可以想像的那樣，在我們驗證並獲得牽引力之前，我們將在將任何真正的顯著收入增長納入我們的指導方面採取適當的保守態度。因此，1550 萬美元雖然確實包括了最近發布的產品的一些收入，但這並不是其全部驅動力。這是增量的一部分。

You had asked about could we provide a bit more context and color between the products. And we're not in a position here and nor do we believe it's all that helpful for investors to be getting a lot of product level detail on revenue at the current stage of these products, they're pretty modest still, even though we're guiding to $15.5 million, there is noise. And I don't think it is very helpful from a modeling perspective or helping provide any real perspective that will be of use.

您曾詢問我們能否在產品之間提供更多背景資訊和顏色。我們不處於這個位置，我們也不相信在這些產品的現階段獲得大量產品層面的收入詳細信息對投資者有幫助，儘管我們的收入仍然相當有限，重新引導至 1550 萬美元時，存在噪音。我認為從建模的角度來看，或幫助提供任何有用的真實視角，這並不是很有幫助。

But what I will say is we have communicated that SurVeil, if you go back to the prepared remarks, was an important contributor, significant contributor, along with Pounce. And as you know, there was no Pounce or no SurVeil product revenue in fiscal '23. So you can imagine that a lot of that growth over $3 million of product revenue growth in med device business. We did see some of that coming from SurVeil and a paramount coming from Pounce. But we're going to provide some color and context but we're just not going to be providing specificity in terms of the numbers at this point. So hopefully, that's helpful. The prepared remarks are intended to help give you what you're looking for. And I'm sure we'll have more to say as we kind of go through the coming quarters in terms of the performance from these recently launched products and the continued performance from SurVeil as well.

但我要說的是，我們已經傳達過，如果你回顧一下準備好的言論，SurVeil 是一個重要的貢獻者，與 Pounce 一起。如您所知，23 財年沒有 Pounce 或 SurVeil 產品收入。因此，您可以想像，超過 300 萬美元的成長大部分來自醫療設備業務的產品收入成長。我們確實看到其中一些來自 SurVeil，而最重要的是來自 Pounce。但我們將提供一些顏色和背景，但目前我們不會提供具體的數字。希望這會有所幫助。準備好的評論旨在幫助您找到所需的內容。我相信，當我們在未來幾季了解這些最近推出的產品的性能以及 SurVeil 的持續性能時，我們會有更多話要說。

And Tim has very long legs, so he can kick me under the table, but I'll give you 1 nugget that, that will help. It wasn't too long ago we were talking about the direct sales of vascular interventions product is without SurVeil, we're getting to $1 million -- over $1 million a quarter consistently. What I will share and this is 1 nugget is Pounce Arterial by itself is over $1 million a quarter. So I can't give you any more than that, but I just -- I wanted to make sure people understood the magnitude of the growth we are experiencing in some of these areas.

提姆的腿很長，所以他可以在桌子底下踢我，但我會給你 1 個金塊，這會有所幫助。不久前，我們還在談論不使用 SurVeil 的血管介入產品的直接銷售，我們的銷售額將達到 100 萬美元——每季持續超過 100 萬美元。我要分享的是，這是一個金塊，Pounce Arterial 本身每季就超過 100 萬美元。所以我不能給你更多的信息，但我只是——我想確保人們理解我們在其中一些領域正在經歷的成長的規模。

Okay. Yes. No, all of that is really helpful, much appreciated. I guess maybe let's see. Maybe 1 on Abbott and SurVeil. Just maybe wondering how long maybe rough time line or something when you guys believe you can get to kind of a reasonable medical device gross margin somewhere 60%, 80% with the relationship or I guess -- I guess, how high did the transfer payments seem to get to really realize that -- just I guess, adding 2 kind of subquestions on that. Do you expect any capacity increase in the future? And excluding this milestone payment last year, do you guys expect any gross margin benefit or improvement this year?

好的。是的。不，所有這些都非常有幫助，非常感謝。我想也許讓我們看看吧。也許是 Abbott 和 SurVeil 上的 1。只是想知道大概的時間線要多長，或者當你們相信你們可以透過這種關係達到 60%、80% 的合理醫療器械毛利率，或者我猜——我猜，轉移支付有多高似乎真正意識到這一點——只是我猜，在上面添加了兩種子問題。您預計未來產能是否會增加？排除去年的里程碑付款，你們預計今年的毛利率會提高或改善嗎？

I'll turn over to Tim for the final point. But just when you -- and this will apply to all of our -- the VI (inaudible) inventions products as well. So when you launch a product, and the first thing you want to know is you get a stable product performing in the marketplace. And any product is small tweaks and engineering change orders. So until we have a stable product, we don't like to commit it to a low-cost environment that makes thousands of them in 1 -- just in a specific operation.

我將把最後一點交給蒂姆。但就在您——這將適用於我們所有的——VI（聽不清楚）發明產品時。因此，當您推出產品時，您想知道的第一件事就是您的產品在市場上表現穩定。任何產品都是小的調整和工程變更單。因此，在我們擁有穩定的產品之前，我們不希望將其投入到低成本環境中，將數千個產品合而為一——僅在特定操作中進行。

So some of these products are achieving stability right now, like the first portion of Pounce Arterial. Then, when the product is stable and we're satisfied stable, then we can really drive cost out. And there are 2 things helping us there. One is the cost volume profit relationship that helps absorb overhead. That really does that. And then the second 1 is we can lean out those lines specifically because we know we're making it in that exact variance forever more.

因此，其中一些產品目前正在實現穩定，例如 Pounce Arterial 的第一部分。然後，當產品穩定並且我們對穩定感到滿意時，我們就可以真正降低成本。有兩件事可以幫助我們。一是有助於吸收管理費用的本量利關係。確實是這樣的。然後第二個 1 是我們可以專門精簡這些線，因為我們知道我們將永遠以更精確的變異數來製作它。

As far as SurVeil goes, as Tim has mentioned in the past, and all of these products, we built the fixed infrastructure to scale. So we don't see need for huge capital equipment when we do scale. And so Tim will talk about that. But in the early days, we're just overhead is not our friend. Volume is our friend to overcome that overhead absorption. Tim?

就 SurVeil 而言，正如 Tim 過去提到的，以及所有這些產品，我們建造了可擴展的固定基礎設施。因此，當我們擴大規模時，我們認為不需要龐大的資本設備。蒂姆將談論這個問題。但在早期，我們只是架空並不是我們的朋友。成交量是我們克服開銷吸收的朋友。提姆？

I really like the question. And if you go back and take a look at what the product gross margin was for the quarter, it was just under 61%. And I'm quite sure and convinced that it's significantly higher than the consensus estimate. But you'll have heard me comment during the modeling considerations portion of the script that we now expect product gross margins to range from mid-50s to high 50s. If you go back and compare to what we said during the February call, we said mid-50s.

我真的很喜歡這個問題。如果你回頭看看該季度的產品毛利率是多少，你會發現它略低於 61%。我非常確定並確信它明顯高於共識估計。但您會在腳本的建模考慮部分聽到我評論說，我們現在預計產品毛利率在 50 多歲到 50 多歲之間。如果你回顧我們在 2 月電話會議中所說的內容，我們說的是 50 年代中期。

So there's a reason why we're migrating favorably on the product gross margins, and that's because we're seeing the benefits of scale. Clearly, we had a really strong Q2. Product revenue outperformed our expectations and consensus. We're pushing that through the rest of the year. Justin, as you mentioned, you highlighted that there's a couple of new products. Obviously, we've got that reflected in on a modest level, but scale helps. And we're also becoming more efficient in the manufacturing.

因此，我們在產品毛利率上取得有利的進展是有原因的，那是因為我們看到了規模的好處。顯然，我們的第二季非常強勁。產品收入超出了我們的預期和共識。我們將在今年剩餘時間內推動這項進程。賈斯汀，正如您所提到的，您強調了有幾種新產品。顯然，我們已經在一定程度上反映了這一點，但規模有所幫助。我們的製造效率也越來越高。

As Gary mentioned, it's 1 thing to have a small number of products that you're manufacturing on a monthly basis or a quarterly basis, and that grows. But our teams are becoming more efficient in the manufacturing environment. And so we're getting the benefit of improved yields and being able to manufacture these products more effectively and efficiently. And that's what's driving the guidance there. In terms of when we can get to med tech like gross margins, I would say we've made a substantial step-wise function, higher improvement in product gross margins for the likes of SurVeil and Pounce over the last quarter.

正如加里所提到的，每月或每季生產少量產品是一回事，而且這種情況會不斷增長。但我們的團隊在製造環境中變得更有效率。因此，我們受益於產量的提高，並能夠更有效和高效地製造這些產品。這就是推動那裡的指導的原因。就我們何時能夠達到像毛利率這樣的醫療技術而言，我想說我們已經做出了實質性的逐步調整，SurVeil 和 Pounce 等產品的毛利率在上個季度有了更高的改善。

And we continue to have scale. I think we'll continue to do that. We'll continue to be more efficient. But I won't be so bold to tell you precisely when we think we'll get there. But I will tell you that if we continue to grow at the rate that we're growing, it should probably be a couple of years, but if even -- but, again, we're very pleased with the performance and a lot of the credit goes to the ops team.

我們繼續保持規模。我想我們會繼續這樣做。我們將繼續提高效率。但我不會如此大膽地告訴你我們何時能實現這一目標。但我會告訴你，如果我們繼續以現在的速度成長，可能需要幾年的時間，但即使如此——但是，我們對我們的表現和很多方面感到非常滿意這要歸功於營運團隊。

Yes. I mean, there are scenarios where we can get there in calendar '25, but we don't want to give -- we don't want to give the guidance for FY '25 quite yet.

是的。我的意思是，在某些情況下我們可以在 25 年日曆中實現這一目標，但我們不想給出 - 我們還不想給出 25 財年的指導。

Sure, sure. All right. Well, thank you very much for all the details, super helpful. And congrats on the quarter.

當然，當然。好的。嗯，非常感謝您提供的所有詳細信息，非常有幫助。恭喜本季。

Our next question comes from Jim Sidoti from Sidoti & Company.

我們的下一個問題來自 Sidoti & Company 的 Jim Sidoti。

First one, a quick one. Other than that $1.4 million of catch-up revenue, was there anything in the quarter you would consider onetime that added to revenue?

第一個，很快的。除了 140 萬美元的追趕收入之外，本季還有什麼事情您會考慮一次性增加收入嗎？

No. That $1.4 million catch-up payment is really the 1 thing that was unique to the quarter that would -- could be considered to be more of a onetime.

不。

Okay. And I know you're reluctant to give any product-specific guidance, but I'm sure you have internal projections for SurVeil. Can you just give us a sense, are you exceeding those internal projections and by approximately how much? on a percentage basis?

好的。我知道您不願意提供任何特定於產品的指導，但我確信您對 SurVeil 有內部預測。您能否告訴我們，您是否超出了這些內部預測以及大約超出了多少？以百分比計算？

I like the question, Jim. I'll restrain myself from giving you an answer other than to say it's -- it's -- obviously, we had a really strong quarter in Q2, exceeded our expectations, exceeded consensus. You saw that we raised past the beat, which implies that we have confidence in the second half of the year. We have not changed our guidance with regard to the IVD and Coatings business.

我喜歡這個問題，吉姆。我會克制自己不給你一個答案，只是說，顯然，我們在第二季度的季度表現非常強勁，超出了我們的預期，超出了共識。你看到我們已經超越了節奏，這意味著我們對下半年有信心。我們沒有改變對 IVD 和塗料業務的指導。

So I think that probably gives you the insight that I want you to take away. We are very pleased with the performance with SurVeil, Pounce, and Sublime.

所以我認為這可能會給你帶來我希望你帶走的見解。我們對 SurVeil、Pounce 和 Sublime 的表現非常滿意。

Okay. And then just a question on the sales team. I know you've made some changes to that last year. Is it time to expand again? And can you talk a little bit about international? You don't have any sales there now. Have you considered distribution for sales outside the United States?

好的。然後是關於銷售團隊的問題。我知道你去年對此做了一些改變。是時候再次擴張了嗎？能談談國際化嗎？你那裡現在沒有任何銷售。您是否考慮過在美國境外進行銷售分銷？

We -- the short answer is, we have considered all options internationally, but like the Roman Empire, we want to be able to make sure we secure the U.S. market first. And we're trying to be quite disciplined on where we allocate investments on capital, especially given the show returns over the short-term horizon here versus too many long-term deep passes. So the short answer is no, not at this point, but it is not off the table. It will only be on the table if it doesn't impact our cash utilization. We don't want to spend more cash at this point to go to other geographies. But if there's a partner and a capability where we can demonstrate it's not the use of cash, we'll consider it.

我們——簡短的回答是，我們已經考慮了國際上的所有選擇，但像羅馬帝國一樣，我們希望確保我們首先確保美國市場的安全。我們正在努力嚴格控制資本投資的分配，特別是考慮到該劇的短期回報與太多長期深度通行證的回報。所以簡短的回答是否定的，目前還不行，但也不是不可能的。只有在不影響我們的現金利用率的情況下，它才會被擺在桌面上。我們現在不想花更多的錢去其他地區。但如果我們有合作夥伴並且有能力證明這不是使用現金，我們就會考慮。

And the first part of the question was, was that it I think that was?

問題的第一部分是，我認為是這樣嗎？

on the U.S. sales force, are you happy with...

對於美國的銷售隊伍，您對...感到滿意嗎？

Yes. So look, we -- I'll tell you, we have concentrated and curated an amazing sales team here. And they continue to impress me, they're building territories from scratch, and that's never easy. Finally, people are not just saying Surmodics who people realizing us. We made a Morgan Stanley report recently on a KOL (inaudible) Morgan Stanley doesn't even cover us. But the short answer is, we will continue to look for opportunities to grow but it's not just a mass sprinkling of territories. We're really being quite selective with our sales leadership, where the heat maps are and where the opportunities lie.

是的。所以，我告訴你，我們在這裡集中並組建了一支出色的銷售團隊。他們繼續給我留下深刻的印象，他們從頭開始建立領土，這絕非易事。最後，人們不只是說 Surmodics，而是人們認識到我們。我們最近做了一份摩根士丹利關於 KOL（聽不清楚）的報告，摩根士丹利甚至沒有涵蓋我們。但簡短的答案是，我們將繼續尋找成長機會，但這不僅僅是大量分散的領土。我們對銷售領導確實非常挑剔，熱圖在哪裡，機會在哪裡。

Now Pounce venous and how that goes in the next couple of quarters could change our allocation of that because to cover territories expenses, which were salaries, commissions and expenses, Pounce Venous is a very high ASP product as is Pounce Arterial as well. And so if that allows us to start covering territory expenses at an accelerated fashion, then we still use the term go as we grow or grow as we go. We can see the territories we want. So we're not too far ahead of cash utilization. Cash is very important to us, as you can tell.

現在，Pounce venous 以及接下來幾季的情況可能會改變我們的分配，因為為了支付地區費用，即薪水、佣金和費用，Pounce Venous 是一種 ASP 非常高的產品，Pounce Arterial 也是如此。因此，如果這使我們能夠開始以加速的方式支付領土費用，那麼我們仍然使用術語“go as we go”或“row as we go”。我們可以看到我們想要的領土。因此，我們在現金利用方面並沒有領先太多。如您所知，現金對我們非常重要。

Right. Right. And it doesn't appear that you're going to need to raise cash anytime soon that the cash you have on the balance sheet is more than enough to fund the growth.

正確的。正確的。而且，您似乎不需要很快籌集現金，因為資產負債表上的現金足以為成長提供資金。

Yes. And I hope investors get the point of what we're seeing in this quarter is how we have managed cash looking forward and also how we've done it in this quarter.

是的。我希望投資者明白我們在本季看到的重點是我們如何管理未來的現金以及我們在本季的表現。

Our next question comes from Mike Petusky from Barrington Research.

我們的下一個問題來自 Barrington Research 的 Mike Petusky。

Tim, I may have missed this. Did you say whether the profit-sharing piece for SurVeil, like has that started? Are you guys participating in that at this point? Or is that not been calculated yet on these first orders?

提姆，我可能錯過了這個。您是否說過 SurVeil 的利潤分享部分是否已經開始？你們現在參與其中嗎？或是這些第一批訂單還沒計算過嗎？

Yes. Thank you for the question, Mike. Yes, we've communicated on this topic in the past. Probably weren't very clear on it here during our prepared remarks. But yes, the way the profit sharing works, it's not unlike what we have to do with our royalties. For those of you who followed the story for a while, you appreciate that given the accounting standards, we have to make an estimation of what our customers sell and what our royalty will be on the coatings part of the business.

是的。謝謝你的提問，麥克。是的，我們過去曾就這個話題進行過交流。在我們準備好的發言中可能對此不太清楚。但是，是的，利潤分享的運作方式與我們處理版稅的方式沒有什麼不同。對於那些關注這個故事一段時間的人來說，您會意識到，考慮到會計標準，我們必須估計我們的客戶銷售的產品以及我們在塗料業務部分的特許權使用費。

It's not unlike that with regard to the profit sharing with SurVeil. So when we ship product to Abbott, we calculate based upon the unit shift what the profit sharing will be based upon a number of assumptions, including the selling price and including the number of units that are actually sold. So we have to take into consideration units that are used for promotional or samples that aren't charged as well as units that might expire. Recall, we have a 2-year shelf life.

這與 SurVeil 的利潤分享沒有什麼不同。因此，當我們將產品運送到雅培時，我們會根據單位變動計算利潤分成，具體基於許多假設，包括銷售價格和實際銷售的單位數量。因此，我們必須考慮用於促銷的單位或不收費的樣品以及可能過期的單位。回想一下，我們的保存期限為 2 年。

So we're pretty conservative in these assumptions at the moment. We have yet to receive the first profit sharing report from Abbott. We'll have a little bit more insight on the first 1 when we get together for the August call. But there is an amount that's included in the product revenue, which obviously impacts the product gross margins, but we've not made any changes to our assumptions from what we included in Q1 relative to what we booked in Q2 and how we forecast for the full year. So no changes there.

所以目前我們對這些假設相當保守。我們尚未收到雅培的第一份利潤分享報告。當我們聚在一起參加八月的電話會議時，我們將對第一個問題有更多的了解。但產品收入中包含了一定金額，這顯然會影響產品毛利率，但我們沒有對第一季度中包含的內容相對於第二季度預訂的內容以及我們對未來的預測做出任何改變全年。所以那裡沒有變化。

Okay. So essentially, you're saying you could come back and say, okay, well, we did a reconciliation with Abbott and there's a disagreement so we have to sort of back off although it sounds like you're being -- you're trying to be conservative with this.

好的。所以本質上，你是說你可以回來說，好吧，好吧，我們與雅培達成了和解，但存在分歧，所以我們必須退縮，儘管聽起來你正在——你正在嘗試對此持保守態度。

Yes. I think the probability of that risk without having perfect clarity would be low. I think that there's -- the probability, in my view would be that it would be favorable versus unfavorable. But I'm sitting here today on May 1st, not having received any reports from Abbott with regard to the key assumptions that we've modeled. We've gotten a little feedback in some insights that we've used in some market data, but I feel comfortable with regard to what we've included in our assumptions to derive or come up with our estimated profit sharing, Mike.

是的。我認為，如果沒有完全明確的情況，這種風險的可能性就會很低。我認為，在我看來，可能性是有利的還是不利的。但我今天 5 月 1 日坐在這裡，沒有收到雅培關於我們建模的關鍵假設的任何報告。我們在一些市場數據中使用的一些見解得到了一些回饋，但我對我們在推導或提出估計利潤分享的假設中所包含的內容感到滿意，麥克。

Okay. All right. Very good. And then I haven't heard this talked about, I don't think, in a while. In terms of of Abbott's plans for SurVeil OUS, have they communicated anything there as far as timing or even plans to do it?

好的。好的。非常好。然後我想，我已經有一段時間沒有聽到有人談論這個話題了。就 Abbott 的 SurVeil OUS 計劃而言，他們是否就時間甚至計劃進行了溝通？

There's no change. What they have communicated is that they want to really make sure they fill out this U.S. market first. And at some point, if they get to that, we'll have that discussion and an appropriate point if it's reportable, we will. But so far, no.

沒有任何變化。他們傳達的訊息是，他們希望真正確保首先填補美國市場。在某個時候，如果他們做到了這一點，我們將進行討論，並提出一個適當的觀點（如果可以報告的話），我們會的。但到目前為止，還沒有。

Okay. So not even like sort of like, hey, we sort of run this business for 6 quarters in the U.S. and then we start -- like there's nothing on the drawing board in terms of longer-term plan there?

好的。所以，甚至不像，嘿，我們在美國經營這項業務 6 個季度，然後我們就開始了——好像那裡沒有任何長期計劃？

Yes. We have not had those discussions yet.

是的。我們還沒有進行這些討論。

We wouldn't have visibility to that at this point, Mike. They've not commented on that, nor have we asked quite frankly. But we're -- I think we're all focused on making sure that we're able to supply not only product, but technical data information that's useful for their marketing and selling and training purposes. We certainly would welcome the opportunity to produce more units for Abbott for sale in other international markets. But that's not what we're manufacturing today. It's only U.S.

麥克，我們現在還看不到這一點。他們沒有對此發表評論，我們也沒有坦率地詢問。但我認為我們都專注於確保我們不僅能夠提供產品，而且能夠提供對他們的營銷、銷售和培訓目的有用的技術數據資訊。我們當然歡迎有機會為雅培生產更多產品並在其他國際市場銷售。但這不是我們今天製造的。這只是美國

Okay. And just last question. Obviously, the first couple of quarters of this fiscal have come in really strongly. I think a lot of people -- people we've talked to are sort of interested in what '25 could look like -- and I'm just curious, I mean, is there any chance that you guys may give sort of a little bit of a preview on that, say, before the fourth quarter conference call. Like is there a chance that maybe after the third quarter or something towards the end of this...

好的。最後一個問題。顯然，本財年的前幾季的表現非常強勁。我認為很多人——我們採訪過的人都對 25 歲的樣子感興趣——我只是很好奇，我的意思是，你們有沒有機會給予一點幫助例如，在第四季度電話會議之前對此進行一些預覽。就像有沒有可能在第三季之後或接近尾聲的時候...

I want to say more likely not. And not because we're trying to be coy only. We have multiple hypotheses and assumptions that we're validating. And some of those data points, again, we're just launching a couple of products right now. So the way we look at fiscal '25 is we have hypothesis where those products get to. If it's above the low and then we then change our assumptions before that. And given the fact that we're so close to the end of the fiscal year, even then we wouldn't have as many data points as that would typically like to have. So I would say June until the November fourth quarter earnings call.

我想說更有可能不是。並不是因為我們只是想含糊其辭。我們正在驗證多個假設和假設。其中一些數據點再次表明，我們現在剛剛推出了幾種產品。因此，我們看待 25 財年的方式是假設這些產品的去向。如果它高於最低點，那麼我們就改變先前的假設。考慮到我們已經如此接近財政年度結束的事實，即使如此，我們也不會擁有通常希望擁有的那麼多數據點。所以我想說的是 6 月到 11 月的第四季財報電話會議。

We are currently seeing no remaining questions at this time. That does conclude our conference for today. Thank you for your participation.

目前我們沒有發現任何剩餘問題。我們今天的會議到此結束。感謝您的參與。