Orthofix Medical Inc (OFIX) 2025 Q1 法說會逐字稿

Thank you for standing by. My name is Tina, and I will be your conference operator today. At this time, I would like to welcome everyone to Orthofix's first-quarter 2025 earnings call. (Operator Instructions) I will now turn the call over to Julie Dewey. Please go ahead.

感謝您的支持。我叫蒂娜，今天我將擔任您的會議接線生。現在，我歡迎大家參加 Orthofix 2025 年第一季財報電話會議。（操作員指示）現在我將把電話轉給朱莉·杜威。請繼續。

Thank you, operator, and good morning, everyone. Welcome to Orthofix's first-quarter 2025 earnings call. We appreciate you joining us. I'm Julie Dewey, Orthofix's Chief IR and Communications Officer. Joining me on the call today are President and CEO, Massimo Calafiore; and Chief Financial Officer, Julie Andrews.

謝謝接線員，大家早安。歡迎參加 Orthofix 2025 年第一季財報電話會議。感謝您的加入我們。我是 Julie Dewey，Orthofix 的首席投資者關係和通訊官。今天與我一起參加電話會議的還有總裁兼執行長 Massimo Calafiore；以及財務長朱莉·安德魯斯 (Julie Andrews)。

Before we get started, please note that our earnings release and the supplemental presentation accompanying this call are available on the Events and Presentations page of the Investors section of our corporate website at orthofix.com. Also, this call is being broadcast live over the Internet to all interested parties, and an archived copy of this webcast will be available in the Investors section of our corporate website shortly after the conclusion of this call.

在我們開始之前，請注意，我們的收益報告和本次電話會議的補充簡報可在我們公司網站 orthofix.com 的投資者部分的活動和簡報頁面上找到。此外，本次電話會議將透過網路向所有相關方進行現場直播，會議結束後不久，我們公司網站的「投資者」部分將提供本次網路直播的存檔副本。

During this call, we will be making forward-looking statements that involve risks and uncertainties. All statements other than those of historical facts are forward-looking statements. We do not undertake any obligation to revise or update such forward-looking statements. Factors that could cause actual results to differ materially are discussed in our most recent filings with the SEC and may be included in our future filings with the SEC.

在本次電話會議中，我們將做出涉及風險和不確定性的前瞻性陳述。除歷史事實之外的所有陳述均為前瞻性陳述。我們不承擔修改或更新此類前瞻性陳述的任何義務。我們最近向美國證券交易委員會提交的文件中討論了可能導致實際結果大不相同的因素，並可能將其納入我們未來向美國證券交易委員會提交的文件中。

In addition, on today's call, we will refer to various non-GAAP financial measures. Please refer to today's news release announcing our first quarter 2025 results for information regarding our non-GAAP results, including our reconciliations of these non-GAAP financial measures to our US GAAP results. Additionally, and unless otherwise stated, all net sales percentage changes discussed will be on a pro forma same sales day, constant currency, year-over-year basis excluding the impact from the discontinuation of the M6 artificial disc product lines and all results of operations that we will refer to will be on a non-GAAP as adjusted basis.

此外，在今天的電話會議上，我們將參考各種非公認會計準則財務指標。請參閱今天宣布我們 2025 年第一季業績的新聞稿，以了解有關我們的非 GAAP 業績的信息，包括我們將這些非 GAAP 財務指標與美國 GAAP 業績進行對帳。此外，除非另有說明，所有討論的淨銷售額百分比變化都將以同一銷售日、固定匯率、同比為基礎，不包括 M6 人工椎間盤產品線停產的影響，並且我們將參考的所有經營業績都將以非 GAAP 調整後為基礎。

Moving to today's agenda. Massimo will open with comments on our performance and business updates. Julie Andrews will then review the specifics of our first quarter results and our 2025 financial guidance. With that, I will now turn the call over to Massimo.

轉到今天的議程。Massimo 將首先對我們的業績和業務更新發表評論。朱莉安德魯斯隨後將回顧我們第一季業績的具體情況和 2025 年財務指導。說完這些，我現在將電話轉給馬西莫。

Thank you, Julie. Good morning, everyone, and thank you for joining us for our first quarter earnings call. I'll spend some time providing business updates and information about our key initiatives before I turn it over to Julie Andrews, to cover the specifics of our Q1 results and 2025 guidance. During the first quarter, we continued to execute the priorities that we outlined in our three-year plan to transform our business and deliver on our commitment to drive disciplined profitable growth. On a same sales day basis, our first-quarter pro forma net sales of $189.2 million represent year-over-year constant currency growth of 6%.

謝謝你，朱莉。大家早安，感謝大家參加我們的第一季財報電話會議。在將時間交給朱莉·安德魯斯 (Julie Andrews) 之前，我會花一些時間提供業務更新和有關我們主要舉措的信息，以介紹我們第一季度業績和 2025 年指引的具體細節。在第一季度，我們繼續執行三年計劃中概述的優先事項，以轉變我們的業務並履行推動有紀律的盈利增長的承諾。以同日銷售計算，我們第一季的預測淨銷售額為 1.892 億美元，以固定匯率計算年增 6%。

I'm also pleased to report that we delivered another quarter of excellent progress in adjusted EBITDA margin expansion that exceeded expectations. As we move forward in 2025, I'm confident we are well positioned for profitable growth as our efforts to further optimize our spine commercial channel begin to bear fruit and we continue to build on our financial foundation and prudent depo capital to create long-term value for our shareholders.

我還很高興地報告，我們在調整後 EBITDA 利潤率擴張方面又取得了超乎預期的出色進展。隨著我們邁向 2025 年，我相信我們已為實現盈利增長做好了準備，因為我們進一步優化主幹商業管道的努力開始取得成果，而且我們將繼續鞏固我們的財務基礎和審慎的存款資本，為股東創造長期價值。

Our excitement continues to build in our orthopedics business and the greenfield opportunity we have to redefine the category of limber construction, which I'll discuss in more detail shortly as well as prospect we have in our Bone Growth Therapies business to further capitalize on cross-selling opportunities and drive penetration in the tractor market with AccelStim. Now I'd like to provide additional detail for each of our businesses.

我們對骨科業務和重新定義肢體構造類別的綠地機會的興奮感不斷增加，我將很快詳細討論這一點，以及我們在骨骼生長療法業務中的前景，以進一步利用交叉銷售機會並通過 AccelStim 推動拖拉機市場的滲透。現在我想為我們的每個業務提供更多細節。

Our US Spinal Succession business grew 5.4% on a same sales day basis. We are successfully accelerating targeted distributor transition in a few US territories in order to maximize our growth opportunity and more closely align with our strategic focus. As a result, we did experience some short-term incremental softness in Biologics and Spine Fixation. This transition won't be completed until later this year, and will require some time to take full effect, but is expected to result in a stronger, more scalable commercial organization as we shift into our next phase of growth.

我們的美國 Spinal Succession 業務在同一天的銷售額上成長了 5.4%。我們正在成功地加速美國一些地區的目標經銷商轉型，以最大限度地擴大我們的成長機會，並更緊密地與我們的策略重點保持一致。因此，我們確實在生物製劑和脊椎固定方面經歷了一些短期增量軟化。這一轉變要到今年稍後才能完成，並且需要一些時間才能全面生效，但隨著我們進入下一階段的成長，預計這將帶來更強大、更具可擴展性的商業組織。

Once our optimization efforts are completed, we expect growth to return to historical levels. During the quarter, we continued to gain in product categories where we recently launched new products, including our ELF, MIS and cervical fusion portfolios all of which significantly outperformed the market. Beginning in Q2, we have several product launches planned, including the full launch of [LLIF L] lateral lumbar interbody and additional solution in our Meridian ALIF portfolio.

一旦我們的優化工作完成，我們預計成長將恢復到歷史水平。在本季度，我們最近推出的新產品的產品類別持續成長，包括我們的 ELF、MIS 和頸椎融合產品組合，所有這些產品的表現都遠遠優於市場。從第二季開始，我們計劃推出多款產品，包括全面推出 [LLIF L] 側腰椎椎間盤突出症以及 Meridian ALIF 產品組合中的附加解決方案。

This new interbody design features our proprietary advanced surface technologies and expand our portfolio of lumbar interbody fusion products to address varying surgeon preference and patient anatomies. In parallel, we will integrate our hardware products with access and navigation, creating a comprehensive procedural solution to enhance efficiencies and predictabilities in the OR.

這種新的椎間設計採用了我們專有的先進表面技術，並擴展了我們的腰椎椎間融合產品組合，以滿足不同外科醫生的偏好和患者的解剖結構。同時，我們將把我們的硬體產品與存取和導航相結合，創建一個全面的程序解決方案，以提高手術室的效率和可預測性。

At the same time, we continue to leverage our differentiated 7D flash navigation platform to create long-standing relationships with our surgeon partners. With continued investment, we expect that our next-generation advancements in enabling technology, and our hardware portfolio will build upon this unique foundation and establish us as the partner of choice for surgeons seeking real-time data-driven interoperative solution in the OR.

同時，我們繼續利用我們差異化的 7D 閃光導航平台與我們的外科醫生合作夥伴建立長期關係。透過持續投資，我們期望我們在支援技術方面的下一代進步以及我們的硬體產品組合將建立在這個獨特的基礎之上，並使我們成為尋求手術室實時數據驅動的手術間解決方案的外科醫生的首選合作夥伴。

We believe that our comprehensive portfolio of spinal hardware, biologics and enabling technologies and steady cadence of innovation will enable us to attract top sales talent, increase exclusive distributor relationships and drive sticky relationships with surgeons and hospital accounts, which we expect to result in incidental product pull-through as well as ASP lift from mix benefits.

我們相信，我們全面的脊椎硬體、生物製劑和使能技術產品組合以及穩定的創新節奏將使我們能夠吸引頂尖銷售人才、增加獨家經銷商關係並與外科醫生和醫院帳戶建立緊密關係，我們預計這將帶來偶然的產品拉動以及混合效益帶來的平均售價提升。

Now turning to Bond Growth Therapies. On a same sales day basis, BGT net sales grew 7% overall in Q1 and investments in the structured market sales channel drove 8% growth in BGT structure with AccelStim bond growth therapy device to continuing to outperform the market. Our BGT business is focused on maximizing our market-leading position with the most comprehensive portfolio and the most indications on bone growth stimulation devices in the market. We will continue to focus on cross-selling with orthopedic spine, adding new market channels with established sales representative and driving penetration in the fracture market with AccelStim.

現在轉向債券增長療法。以同日銷售計算，BGT 第一季淨銷售額整體成長 7%，結構化市場銷售通路的投資推動 BGT 結構成長 8%，AccelStim 債券成長治療設備持續跑贏市場。我們的 BGT 業務致力於透過市場上最全面的產品組合和最多的骨骼生長刺激設備適應症來最大限度地鞏固我們的市場領先地位。我們將繼續專注於骨科脊椎的交叉銷售，透過現有的銷售代表增加新的市場管道，並透過 AccelStim 推動骨折市場的滲透。

Speaking of AccelStim, we received an earlier-than-anticipated FDA approval for our AccelStim 2.0 in the first quarter. This approval reinforces Orthofix's position as the market leader in bond growth simulation and represents a significant advancement in low-intensity post ultrasound technology as the first and only such device to incorporate remote therapeutic visibility through integration with the STIM onTrack mobile app and physician portal. AccelStim 2.0 is expected to be available later this year.

說到 AccelStim，我們在第一季就比預期更早獲得了 FDA 對 AccelStim 2.0 的批准。此次批准鞏固了 Orthofix 在鍵合生長模擬領域的市場領先地位，並代表了低強度後超音波技術的重大進步，Orthofix 是第一款也是唯一一款透過與 STIM onTrack 行動應用程式和醫生入口網站整合來實現遠端治療可視性的裝置。AccelStim 2.0 預計將於今年稍後上市。

I continue to be impressed by the commercial execution of the BGT team. Our global orthopedic business had a strong start to the year, delivering constant currency growth of 13% on a same sales day basis in Q1 compared to prior year. US Orthopedics benefited from strong execution and grew 12%, also on a same sales day basis. Growth was led by the combination of our TrueLok and FITBONE products as well as growth in the Galaxy Fixation product family and OSCAR bone cement removal products.

BGT 團隊的商業執行力繼續給我留下深刻的印象。我們的全球骨科業務今年開局強勁，第一季以同日銷售額計算，與去年同期相比，固定匯率成長率達 13%。美國骨科業務受益於強勁的執行力，銷售額年增 12%，且與同日銷售額持平。成長主要得益於我們的 TrueLok 和 FITBONE 產品組合以及 Galaxy Fixation 產品系列和 OSCAR 骨水泥去除產品的成長。

As we covered in our last earnings call, Orthofix is redefining the category of limber construction with a unique portfolio solutions that empower surgeons to excel a limb preservation, deformity correction, limb lengthening and complex structure management. Together, these segments represent a market opportunity in excess of $1.7 billion, one of the fastest-growing categories in orthopedics.

正如我們在上次收益電話會議上所述，Orthofix 正在透過獨特的產品組合解決方案重新定義肢體建構的類別，使外科醫生能夠出色地進行肢體保存、畸形矯正、肢體延長和複雜結構管理。這些領域合計代表超過 17 億美元的市場機會，是骨科領域成長最快的類別之一。

We are particularly excited about the upcoming full market release of the TrueLok Elevate TBT system, which is indicated to correct nonunion and bone or soft tissue deformities or defects, which could include non-healing wounds, ulcers and deep tissue wounds. According to the American Diabetes Association, over 160,000 amputations occur each year in the US. As a result, of diabetic-related complication, representing a sizable market opportunities of approximately $1.2 billion.

我們對即將全面上市的 TrueLok Elevate TBT 系統感到特別興奮，該系統用於糾正不癒合和骨骼或軟組織畸形或缺陷，其中可能包括不癒合的傷口、潰瘍和深層組織傷口。根據美國糖尿病協會的數據，美國每年有超過 16 萬例截肢手術。因此，糖尿病相關併發症代表著約 12 億美元的巨大市場機會。

The TrueLok Elevate TBT system is currently a limited market release at select centers in the US and Europe. Surgeons participating in the limited release are witnessing firsthand that the transformative potential of this product in treating condition that previously would have almost certainly resulted in limb amputation and drastically reduce patients' quality of life and their life expectancy. TrueLok Elevate is already making a real difference. We are continuing to prepare for a full market launch of TrueLok Elevate in Q3.

TrueLok Elevate TBT 系統目前在美國和歐洲的部分中心進行有限上市。參與限量發布的外科醫生親眼目睹了該產品在治療以前幾乎肯定會導致截肢並大幅降低患者生活品質和預期壽命的疾病方面的變革潛力。TrueLok Elevate 已經發揮了真正的作用。我們正在繼續為第三季全面推出 TrueLok Elevate 做準備。

These include confirming reimbursement cutting and actively gathering feedback from surgeons involved in the initial rollout. This feedback will be crucial for successful full launch in the coming months. With over 90 TrueLok Elevate cases completed so far, surgeon response has been overwhelmingly positive, and interest from the orthopedic community continues to grow rapidly.

這些措施包括確認削減報銷金額並積極收集參與初步推廣的外科醫生的回饋。這些回饋對於未來幾個月的成功全面發布至關重要。到目前為止，已經完成了 90 多例 TrueLok Elevate 病例，外科醫生的反應非常積極，骨科界的興趣也持續快速增長。

TrueLok Elevate now enables surgeons to effectively address challenging condition in a patient's extremity by allowing for an efficient and reproducible method to create a bond segment in the tibia that can be gradually destructed over a period of several days. Published clinical research has shown that this approach improves [bone] circulation to the affected limb and promote wound healing in diabetic food, potentially reducing the need for an amputation, lowering associated mortality risk and alleviating the long-term health care cost linked to limb loss.

TrueLok Elevate 現在使外科醫生能夠有效地解決患者肢體的棘手狀況，透過一種高效且可重複的方法在脛骨中創建一個可以在幾天內逐漸破壞的粘合段。已發表的臨床研究表明，這種方法可以改善患肢的骨循環並促進糖尿病患者傷口癒合，從而可能減少截肢的需要，降低相關的死亡風險並減輕與肢體缺失相關的長期醫療保健費用。

Thus, TrueLok Elevate offers the potential to not only be a limb and cost-saving device but most importantly, a life-saving solution to a challenging patient population. In addition to TrueLok Elevate, orthopedics growth in 2025 will be fueled by a number of new product introductions that we expect to capture additional market share with existing and new customers. These include the FITBONE transport and lengthening nail, the only bone transport nail available in the United States and the FITBONE (inaudible) We expect all of this product to be in full market release in the second half of 2025.

因此，TrueLok Elevate 不僅可以成為一種節省肢體和成本的設備，最重要的是，它可以成為具有挑戰性的患者群體的救生解決方案。除了 TrueLok Elevate 之外，2025 年骨科業務的成長也將受到一系列新產品的推動，我們預計這些產品將在現有客戶和新客戶中佔據更多市場份額。其中包括 FITBONE 運輸和延長釘、美國唯一可用的骨運輸釘和 FITBONE（聽不清楚）我們預計所有這些產品將於 2025 年下半年全面上市。

Our focus on limb reconstruction is yielding significant results, particularly in the USA market. And we anticipate this will be a key growth driver for Orthofix for many years to come. Overall, we are in great position to capitalize on our recent product launch successes and deliver meaningful innovation to improve outcomes and efficiencies for our surgeon customers and their patients.

我們對肢體重建的關注正在取得顯著成果，尤其是在美國市場。我們預計這將成為未來許多年 Orthofix 的主要成長動力。總體而言，我們處於有利地位，可以利用我們最近的產品發布成功並提供有意義的創新，以改善我們的外科醫生客戶及其患者的治療結果和效率。

We have a healthy commercial pipeline that we believe is poised to deliver substantial revenue growth in the coming months. Importantly, the breadth and depth of Orthofix Spine and Orthopedic offerings provide multiple paths to grow the business as sustained above market rates. We remain the market leader in bone growth therapies, have a comprehensive market-leading biologic portfolio and differentiated products in several specialized orthopedic markets such as complex (inaudible) reconstruction and limb deformity correction.

我們擁有健康的商業管道，相信它將在未來幾個月帶來可觀的收入成長。重要的是，Orthofix 脊椎和骨科產品的廣度和深度提供了多種途徑來維持業務成長並維持高於市場的速度。我們仍然是骨骼生長療法市場的領導者，擁有全面的市場領先生物製劑產品組合，並在復雜（聽不清楚）重建和肢體畸形矯正等多個專業骨科市場擁有差異化產品。

Additionally, our broadened spine portfolio is world-class and is fully supported by a highly differentiated and compelling enabling technology. Looking ahead, we are focused on three strategic priorities: first, further sharpening our commercial execution to drive deeper market penetration through our comprehensive portfolio offering, including the adoption of our 7D FLASH navigation system. Second, implementing projects to improve our gross margin and finally, focus on a disciplined capital allocation, adjusted EBITDA expansion and positive free cash flow generation.

此外，我們擴展的脊椎產品組合是世界一流的，並得到高度差異化和引人注目的支援技術的全面支持。展望未來，我們專注於三個策略重點：首先，進一步加強我們的商業執行力，透過我們全面的產品組合推動更深層的市場滲透，包括採用我們的 7D FLASH 導航系統。其次，實施專案以提高我們的毛利率，最後，專注於嚴格的資本配置、調整後的 EBITDA 擴張和正向自由現金流的產生。

In short, we are well positioned to create long-term value for our shareholders in 2025 and beyond. At the same time, we are confident that our emphasis on responsible capital deployment within our businesses and deemphasizing areas where we have less scale or share will also drive our transformation, support profitable growth and increased penetration of our technology and product platforms in areas where we can win.

簡而言之，我們已做好準備，在 2025 年及以後為股東創造長期價值。同時，我們相信，我們強調在業務中負責任地部署資本，並減少對規模或份額較小的領域的重視，這也將推動我們的轉型，支持盈利增長，並提高我們的技術和產品平台在我們能夠獲勝的領域的滲透率。

In summary, after one year with this new management team, Orthofix is operating with greater discipline, executing priorities and strengthening our balance sheet. I believe we are very well positioned to deliver on our commitment to drive profitable growth and innovation while increasing long-term shareholder value.

總而言之，在新的管理團隊的帶領下，Orthofix 的營運更加規範，執行優先事項並加強了我們的資產負債表。我相信，我們完全有能力履行我們的承諾，推動獲利成長和創新，同時提高長期股東價值。

With that, I'll now turn the call over to Julie to review our first quarter financial results and our 2025 guidance.

現在，我將把電話交給朱莉，讓她回顧我們的第一季財務表現和 2025 年的指引。

Thank you, Massimo, and good morning, everyone. As we get started, all net sales growth rates that I referred to in my prepared comments will be on a pro forma constant currency same sales day basis over the prior year quarter and exclude the impact of net sales related to the discontinuation of the M6 artificial cervical and lumbar disc that we previously announced. These pro forma comparisons are non-GAAP financial measures as described by Julie during the introduction of our call.

謝謝你，馬西莫，大家早安。首先，我在準備好的評論中提到的所有淨銷售額成長率都將基於去年同期的同日銷售額的預測固定匯率，並且不包括我們先前宣布的停產 M6 人工頸椎和腰椎間盤相關的淨銷售額的影響。這些形式比較是非 GAAP 財務指標，正如朱莉在我們電話會議介紹期間所描述的那樣。

As a reminder, this quarter had 63 selling days, which was one less selling day than Q1 2024. Please refer to the non-GAAP reconciliations in our press release, and I strongly encourage you to review the information posted on our website. We have provided you with information to assist you with your modeling and to provide you with pro forma information through the first quarter of 2025.

提醒一下，本季的銷售天數為 63 天，比 2024 年第一季少一天。請參閱我們新聞稿中的非公認會計準則對帳表，我強烈建議您查看我們網站上發布的資訊。我們已向您提供資訊以協助您進行建模，並為您提供截至 2025 年第一季的備考資訊。

During the first quarter, we continued to prioritize investment in innovation, rigorously allocating resources to high-return opportunities to further sustain our share capture in US Spine and US Orthopedics and focus on improving margins and cash, positioning the company for near- and long-term profitable growth. Global Spinal Implants, Biologics and enabling Technology's first quarter pro forma net sales of $104.3 million with year-over-year growth of 4% on a pro forma same sales day basis.

在第一季度，我們繼續優先投資於創新，嚴格將資源分配給高回報機會，以進一步維持我們在美國脊椎和美國骨科的份額，並專注於提高利潤率和現金，為公司實現近期和長期盈利增長做好準備。全球脊椎植入物、生物製劑和支援技術第一季的備考淨銷售額為 1.043 億美元，以備考當日銷售額計算年增 4%。

These results were slightly below our expectations, primarily due to some incremental softness in Biologics and Spine Fixation. In our US Spine Fixation business, procedure volume growth on a same sales day basis was 7%, which was partially offset by the outsized impact of a price decrease due to a joint venture between one of our largest hospital accounts in the Midwest and a large regional group purchasing organization that already had an Orthofix pricing agreement in place. We will be working through this for the remainder of the year.

這些結果略低於我們的預期，主要是由於生物製劑和脊椎固定方面的一些增量軟化。在我們的美國脊椎固定業務中，以同日銷售計算的手術量增加了 7%，但由於我們中西部最大的醫院客戶之一與一家已經簽訂了 Orthofix 定價協議的大型區域集團採購組織成立了合資企業，導致價格下降，從而產生了巨大的影響，但這一增長被部分抵消了。我們將在今年剩餘時間內繼續努力解決這個問題。

Moving now to Bone Growth Therapies. BGT revenue grew 7% on a same sales day basis to $55.1 million in Q1, driven by above-market performance in both the spine and fracture channels. BGT fracture growth was 8% on a same sales day basis driven by investments in the fracture market sales channel. We do expect our BGT growth to remain above market growth rates, currently estimated to be 2% to 3% and continue to moderate somewhat as we move forward in 2025 due to our number one market position in the BGT Spine business and lapping the gains from surgeons acquired last year.

現在轉向骨骼生長療法。由於脊椎和骨折通路表現優於市場，BGT 第一季營收以當日銷售額計算成長 7%，達到 5,510 萬美元。受裂縫市場銷售通路投資的推動，BGT 裂縫銷售額年增 8%。我們確實預計我們的 BGT 成長率將保持高於市場成長率，目前估計為 2% 至 3%，隨著我們在 2025 年的發展，成長率將繼續放緩，這得益於我們在 BGT 脊椎業務中的第一市場地位以及去年從外科醫生那裡獲得的收益。

We will continue to focus on adding new surgeons and competitive surgeon conversions in BGT Spine and continue our commercial focus in the BGT fracture market, where we currently have a lower market penetration and see a substantial opportunity to drive new business with orthopedic surgeons.

我們將繼續致力於在 BGT 脊椎部門增加新的外科醫生和有競爭力的外科醫生轉換，並繼續將我們的商業重點放在 BGT 骨折市場，目前我們在該市場的市場滲透率較低，並且看到了與骨科外科醫生開展新業務的巨大機會。

The global Orthopedics business grew 13% to $29.8 million in the first quarter, led by 12% growth in the US as a result of strong performance across our portfolio as well as distributor expansion and sales channel investments. The International Orthopedics business grew 14% versus prior year. As we've previously said, due to the nature of this business, particularly around the timing and volume of stocking distributor and tender orders, we expect to see variability from quarter-to-quarter in the growth rate.

第一季度，全球骨科業務成長 13%，達到 2,980 萬美元，其中美國業務成長 12%，這得益於我們產品組合的強勁表現以及經銷商擴張和銷售通路投資。國際骨科業務較前一年成長了 14%。正如我們之前所說，由於這項業務的性質，特別是在庫存分銷商和招標訂單的時間和數量方面，我們預計成長率會逐季度變化。

Pro forma non-GAAP adjusted EBITDA, excluding the impact of the discontinuation of the M6 was $11.4 million with pro forma adjusted EBITDA margin expanding approximately 200 basis points compared to reported non-GAAP adjusted EBITDA for the first quarter of 2024. The discontinuation of M6 which has been a negative drag on our profitability in prior periods, drove the majority of the improvement in the quarter.

不包括 M6 停產的影響，備考非 GAAP 調整後 EBITDA 為 1140 萬美元，備考調整後 EBITDA 利潤率與 2024 年第一季報告的非 GAAP 調整後 EBITDA 相比擴大了約 200 個基點。M6 的停產對我們前期的獲利能力產生了負面影響，但卻推動了本季業績的大部分改善。

In addition, we continued our efforts to optimize our shared service functions executing actions to deliver annual savings of $3 million. We remain encouraged by these results as we see our ability to drive leverage on sales growth materializing as we continue to focus on disciplined profitable growth. From a cash standpoint, our total cash balance including restricted cash at the end of Q1 totaled $60.5 million.

此外，我們持續努力優化共享服務功能，採取行動實現每年節省 300 萬美元。這些結果讓我們感到鼓舞，因為我們看到，隨著我們繼續專注於有紀律的獲利成長，我們推動銷售成長的能力正在實現。從現金角度來看，我們第一季末（包括受限現金）的總現金餘額為 6,050 萬美元。

As a reminder, the first quarter of each year is always a high cash outflow quarter primarily due to the payment of the prior year's annual bonuses and Q4 commissions. In addition, we had higher than normal cash severance payments related to the discontinuation of M6 and the rightsizing of our shared service functions. Excluding these items, uses of cash were in line with normal business operations and slightly better than the company's projections.

提醒一下，每年的第一季總是現金流出較高的季度，這主要是因為支付了去年的年度獎金和第四季的佣金。此外，由於 M6 的停產和共享服務功能的調整，我們支付的現金遣散費高於正常水準。除這些項目外，現金使用情況與正常業務運作一致，略優於公司的預期。

As we said on our last earnings call, Q1 was expected to be the lowest cash flow quarter of the year. While we continue to expect to generate positive free cash flow, excluding the impact of restructuring charges related to M6 discontinuation for the full year 2025, we do not expect it to generate positive free cash flow in every quarter.

正如我們在上次收益電話會議上所說，預計第一季將是今年現金流最低的季度。雖然我們仍然預計會產生正的自由現金流（不包括與 2025 年全年 M6 停產相關的重組費用的影響），但我們並不預期它每個季度都會產生正的自由現金流。

As we announced on our Q4 earnings call, we are discontinuing the M6C artificial disc and the M6L artificial lumbar disc product lines. It is important to note that the M6 product lines were a headwind to the company's top line revenue growth rate, gross margin, adjusted EBITDA and free cash flow. This product phaseout is in line with our commitment to direct resources to more profitable growth opportunities. We have posted a pro forma P&L for M6 on our website to assist you with updating your models. We will update it on a quarterly basis for the remainder of 2025.

正如我們在第四季度收益電話會議上宣布的那樣，我們將停止生產 M6C 人工椎間盤和 M6L 人工腰椎間盤產品線。值得注意的是，M6 產品線對公司的營業收入成長率、毛利率、調整後 EBITDA 和自由現金流產生了阻力。該產品的逐步淘汰符合我們將資源用於更有利可圖的成長機會的承諾。我們在網站上發布了 M6 的備考損益表，以協助您更新模型。我們將在 2025 年剩餘時間內每季更新一次。

We expect to have onetime cash restructuring charges of approximately $8 million, primarily due to the closure of the dedicated M6 manufacturing facility in Sunnyvale, California. We expect most of the charges to be incurred during 2025. We will continue to support customer demand in the US market as we burn through remaining inventory. In addition, we intend to fulfill all requirements related to post-market surveillance activities and meet our obligations with respect to premarket approval of the M6 devices, including completion of the IDE study in the United States, which we expect to have an annual cost in the range of $2 million.

我們預計一次性現金重組費用約為 800 萬美元，主要原因是關閉位於加州桑尼維爾的專用 M6 製造工廠。我們預計大部分費用將在 2025 年產生。在消耗剩餘庫存的同時，我們將繼續滿足美國市場的客戶需求。此外，我們打算滿足與上市後監測活動相關的所有要求，並履行與 M6 設備上市前批准相關的義務，包括完成美國的 IDE 研究，我們預計每年的成本將在 200 萬美元左右。

Overall, we continue to be confident in our ability to drive profitable revenue growth moving forward. We remain focused on pursuing the vital few initiatives in our long-range plan and prudently deploying capital and resources to areas where we have a differentiated advantage, all of which we believe will support the achievement of our three-year financial targets and propel our business forward.

整體而言，我們仍然對未來推動獲利收入成長的能力充滿信心。我們將繼續專注於長期計劃中少數重要的舉措，並審慎地將資本和資源部署到我們具有差異化優勢的領域，我們相信所有這些都將支持我們實現三年財務目標並推動我們的業務向前發展。

Moving on to 2025 full year guidance. First, regarding tariffs. Recognizing that this is still a fluid situation, we have exposure to tariffs in the EU, Canada, China and Taiwan. We now estimate our annual exposure to be approximately $3 million to $4 million, which is better than our original estimate of $5 million. This estimate includes currently applicable tariffs as well as the additional tariffs that were announced on April 2 by the US that would take effect following the 90-day pause and assume such tariffs remain in place.

繼續制定 2025 年全年指導。第一，關於關稅。我們意識到這仍然是一個不穩定的情況，我們面臨歐盟、加拿大、中國和台灣的關稅風險。我們現在估計我們每年的風險敞口約為 300 萬至 400 萬美元，這比我們最初估計的 500 萬美元要好。這項估計包括目前適用的關稅以及美國於 4 月 2 日宣布的將在 90 天暫停期後生效的額外關稅，並假設這些關稅繼續有效。

This exposure is very manageable primarily reflected in cost of goods sold and are already contemplated in our guidance. We now expect full year net sales of $808 million to $816 million which excludes sales from the discontinued M6 product lines, representing implied constant currency growth of 5% year-over-year at the midpoint of the range.

這種風險非常易於管理，主要反映在銷售成本上，並且已在我們的指導中考慮到。我們現在預計全年淨銷售額為 8.08 億美元至 8.16 億美元，其中不包括已停產的 M6 產品線的銷售額，這意味著按該範圍的中點計算，隱含的恆定貨幣增長率為 5%。

While we no longer expect foreign exchange rates to have a negative impact, our updated guidance reflects the anticipated short-term impact from the targeted distributor transitions that Massimo discussed earlier, which we believe will set us up for success and generate significant future returns. Our guidance also assumes a $5 million negative impact from US funded nongovernmental organization; NGO business as compared to the full year 2024.

雖然我們不再預期外匯匯率會產生負面影響，但我們更新後的指引反映了 Massimo 先前討論過的目標分銷商轉型預期的短期影響，我們相信這將為我們的成功奠定基礎並產生可觀的未來回報。我們的指導也假設美國資助的非政府組織將造成 500 萬美元的負面影響；與 2024 年全年相比，非政府組織業務。

This guidance range is based on the current foreign currency exchange rates and do not take into account any additional potential exchange rate changes that may occur this year. We expect the majority of the impact from our revised net sales guidance to be reflected in the second quarter due to the timing of international stocking orders, the anticipated short-term effect of the targeted distributor transitions and the quarterly impact from the reduction of US funded NGO revenue.

該指導範圍基於當前外幣匯率，並未考慮今年可能發生的任何額外潛在匯率變化。我們預計，修訂後的淨銷售額指引的大部分影響將反映在第二季度，這是由於國際庫存訂單的時間、目標分銷商轉型的預期短期影響以及美國資助的非政府組織收入減少的季度影響。

We continue to expect full year 2025 non-GAAP adjusted EBITDA of $82 million to $86 million, this range includes the anticipated impact from the discontinuation of the M6 product line that was previously announced in February 2025 and represents 190 basis points of EBITDA margin expansion at the midpoint of the range compared to 2024. We also continue to expect to generate positive free cash flow for the full year 2025 excluding the impact of restructuring charges related to the discontinuation of the M6 product lines.

我們繼續預計 2025 年全年非 GAAP 調整後 EBITDA 為 8,200 萬美元至 8,600 萬美元，這一範圍包括了先前於 2025 年 2 月宣布的 M6 產品線停產的預期影響，與 2024 年相比，該範圍中點的 EBITDA 利潤率擴大了 190 個基點。我們也預計，2025 年全年將產生正自由現金流（不包括與 M6 產品線停產相關的重組費用的影響）。

Now for some specifics on individual line items for the P&L for 2025. We expect our gross margin to be approximately 71%, consistent with previous estimates and in line with 2024. We now expect our operating expenses to improve by 200 basis points this year versus 2024 compared to the 100 basis points of improvement we previously communicated. This improvement is expected to come from our continued focus on disciplined investments as well as lower stock-based compensation and depreciation and amortization.

現在來看看 2025 年損益表中各個項目的具體細節。我們預計毛利率約為 71%，與先前的估計一致，也與 2024 年持平。我們現在預計，今年的營運費用將比 2024 年改善 200 個基點，而我們先前傳達的改善幅度是 100 個基點。預計這項改善將來自於我們對嚴格投資的持續關注以及更低的股票薪酬和折舊及攤提。

Stock-based compensation is now expected to be in the range of $29 million to $30 million while depreciation and amortization is expected to decrease to $37 million to $39 million for the full year 2025. We still expect interest and other expenses to be approximately $5 million per quarter. Throughout 2025, we will maintain a heightened focus on disciplined, profitable growth and free cash flow generation to build on our financial foundation and prudently deploy capital to create long-term value for our shareholders.

目前預計股票薪酬將在 2,900 萬美元至 3,000 萬美元之間，而 2025 年全年折舊和攤提預計將降至 3,700 萬美元至 3,900 萬美元。我們仍然預計每季利息和其他支出約為 500 萬美元。在整個2025年，我們將繼續高度關注有紀律的獲利成長和自由現金流的產生，以鞏固我們的財務基礎並審慎地部署資本，為我們的股東創造長期價值。

Now before we open the call for questions, let me turn it back to Massimo for concluding comments. Massimo?

現在，在我們開始提問之前，請允許我把主題轉回給馬西莫，請他發表總結性評論。馬西莫？

Thanks, Julie. I want to thank our Orthofix team and our committed commercial partners for their efforts in Q1. We believe our focused commercial strategy and broad differentiated technology combined with a robust innovation pipeline and our pace setting, enabling technologies position us well to drive commercial execution and operational excellence, deliver on our financial commitments and create long-term sustainable value for shareholders.

謝謝，朱莉。我要感謝我們的 Orthofix 團隊和我們忠誠的商業合作夥伴在第一季所做的努力。我們相信，我們專注的商業策略和廣泛的差異化技術，加上強大的創新管道和領先的技術，使我們能夠很好地推動商業執行和卓越運營，履行我們的財務承諾並為股東創造長期可持續的價值。

I'm excited and energized about the path we have set for ourselves and the opportunities for the business to deliver exceptional value to our surgeons their patient and our shareholders in 2025 and beyond. Operator, let's now open the line for questions.

我對我們為自己設定的道路以及企業在 2025 年及以後為我們的外科醫生、他們的患者和股東提供卓越價值的機會感到興奮和充滿活力。接線員，現在讓我們開始回答問題。

(Operator Instructions)

（操作員指示）

Ryan Zimmerman, BTIG.

Ryan Zimmerman，BTIG。

Hi, good morning, everyone. This is Izzy on for Ryan. Thank you for taking the questions. So to start out, Massimo, I was wondering if you could talk about the rationale for the optimization within the spine channel. What prompted the decision to take this on right now?

大家好，早安。這是 Izzy 為 Ryan 表演的。感謝您回答這些問題。首先，Massimo，我想知道您是否可以談談脊椎通道內優化的理由。是什麼促使您做出現在這項決定？

And if you could put a little bit of a fine point as to how long the process might take? This is a bit of a multipart, so sorry about that. But are there any chance that these impacts could lead into next year or any implications that we should keep in mind for the long-range plan as a result of optimization?

您能否詳細說明一下這個過程可能需要多長時間？這是一個多部分的內容，對此我很抱歉。但是這些影響是否有可能延續到明年，或者在製定優化後的長期計劃時，我們需要牢記哪些影響？

No, definitely not. To give you more color, we're entering -- when we enter the second year of our tenure, we believe that we are a much stronger footing than when we started. Our balance sheet is very strong. We are making a lot of progress on our EBITDA expansion, BTG keep performing, we're redefining the orthopedics and where we are -- as you see, we start to achieve sustainable growth. So for us, it was the moment to really think about our Spine business, and we want to start to be much more deliberate and intentional and how we see how we go to market.

不，絕對不是。為了給你們更多的信息，我們正在進入——當我們進入任期的第二年時，我們相信我們比開始時更加強大。我們的資產負債表非常強勁。我們的 EBITDA 擴張取得了很大進展，BTG 繼續表現出色，我們正在重新定義骨科以及我們所處的位置——正如您所見，我們開始實現永續成長。因此對我們來說，現在是真正思考我們的 Spine 業務的時候了，我們希望開始更加謹慎和有目的性地考慮我們如何進入市場。

So given our strengths, we realized that our current distribution network was already at capacity from the growth standpoint. So we are accelerating our transformation by investing in larger, much more capital-efficient commercial partner to drive the long-term growth that we are expecting to create shareholder value. And I can tell you that the commercial pipeline is already primed and ready to deliver substantial revenue growth starting later this year. It's coming with some pain point short term. But again, we believe that we can create a higher growth business now investing in the right partner.

因此，考慮到我們的優勢，我們意識到從成長的角度來看，我們目前的分銷網絡已經達到了容量上限。因此，我們正在透過投資規模更大、資本效率更高的商業合作夥伴來加速我們的轉型，以推動我們期望創造股東價值的長期成長。我可以告訴你們，商業通路已經準備就緒，並將從今年稍後開始帶來可觀的收入成長。短期內它會帶來一些痛點。但我們再次相信，透過投資合適的合作夥伴，我們現在可以創造更高成長的業務。

That's helpful. Thank you. And Julie, I heard your comments on the 2025 guidance, but I was curious what is enabling you guys to maintain our adjusted EBITDA while lowering the top line?

這很有幫助。謝謝。朱莉，我聽到了你對 2025 年指引的評論，但我很好奇是什麼讓你們能夠在降低營收的同時維持調整後的 EBITDA？

Yeah. So as we mentioned, we've been very focused on making sure that we're making investments that have a return. We did do some rightsizing of care service organization at the beginning of the year as well, which was kind of delivering more on our synergies. As you remember, we had about $10 million going into the year remaining on synergies, and we've kind of now taken actions for about an additional $6 million of that. And so a combination of continuing to deliver on our synergies as well as looking at all of our costs and investing in what we're going to get the highest return on.

是的。正如我們所提到的，我們一直非常注重確保我們所進行的投資能帶來回報。我們在今年年初也對護理服務組織進行了一些調整，這在某種程度上提高了我們的綜效。您還記得，我們​​今年還剩下大約 1000 萬美元用於協同效應，現在我們已經採取行動，額外投入了其中的大約 600 萬美元。因此，我們既要繼續發揮協同效應，又要考慮所有成本，並投資於能夠獲得最高回報的領域。

Understood. Thanks for taking the questions.

明白了。感謝您回答這些問題。

Matthew Blackman, Stifel.

馬修布萊克曼，Stifel。

Good morning, everybody. Thanks for taking our questions. Maybe to start, Julie, you mentioned one less selling day. I just want to make sure I get the simple math. That have amounted to something like 1.5% growth headwind or about, call it, $2 million or $3 million of a year-over-year drag in the first quarter. Is that the right ballpark? And then I've got some follow-ups.

大家早安。感謝您回答我們的問題。也許首先，朱莉，你提到了少了一天的銷售時間。我只是想確保我理解簡單的數學知識。這相當於第一季成長受到 1.5% 左右的阻力，或者說同比去年同期的拖累約為 200 萬或 300 萬美元。這是正確的估計嗎？然後我還有一些後續事宜。

Yeah. It was a little bit over 1.5% of headwind on the quarter growth rate.

是的。這對季度成長率來說略微不利，為 1.5% 多一點。

Okay. I appreciate that. Any -- and I guess, are there any other quarters this year that we should be sensitive to in terms of days selling days versus last year?

好的。我很感激。我想，與去年相比，今年還有哪些季度的銷售天數值得我們關注？

No, the remaining quarters all have the same days as prior years.

不，其餘季度的天數都與前幾年相同。

Okay. Thank you for that. And then I just want to make sure I wrap my head, arms, whatever you want to use around the moving pieces on the updated guide as well as the first quarter. So revenue for the full year comes down about $10 million at the midpoint, $5 million, I think very clearly, federal funding being cut, the remaining $5 million because you obviously mentioned the channel optimization initiatives. But then you also mentioned the pricing headwind in spine from one particular customer. Can you just maybe put a little bit more detail against each of those buckets.

好的。謝謝你。然後我只想確保我用我的頭、手臂以及任何你想用的東西包裹住更新指南以及第一季的移動部件。因此，全年收入在中點下降了約 1000 萬美元，其中 500 萬美元，我認為很明顯，是因為聯邦資金被削減了，剩下的 500 萬美元是因為您顯然提到了渠道優化計劃。但隨後您也提到了來自某位特定客戶的定價阻力。您能否針對每個儲存桶提供更多細節？

I guess the last piece is of all these disruptions you mentioned some in the first quarter in the Spine and Biologics business and then there's the channel optimization and the pricing. Did we see any of this impact in the first quarter? So for instance, that $10 million, I know you said a lot of it in the second quarter, but do we already absorb some of that $10 million headwind here in the first quarter? That's -- those are my three questions. Sorry about all that.

我想最後一點就是您在第一季提到的脊椎和生物製劑業務中遇到的所有這些中斷，然後是通路優化和定價。我們在第一季看到過這種影響嗎？舉例來說，那 1000 萬美元，我知道您在第二季度說了很多，但是我們是否已經在第一季吸收了其中的一部分 1000 萬美元的逆風？這就是──我的三個問題。我很抱歉。

That's fine. Yeah. So let me try to unpack that. So out of the takedown, yes, $5 million is related to the US funded NGO business. The remainder is really Spine and Biologics, I would say, channel disruption. The price we primarily had included in our original guidance. It's a little steeper than we originally, but I would say that was in our original guide. We did see -- yeah, we did take some of that in Q1, both the price and the softness in the distributor channel. We did see some of that in Q1, but we expect the majority of it to be in Q2.

沒關係。是的。那麼讓我試著解釋一下。因此，在此次打擊行動中，有 500 萬美元與美國資助的非政府組織業務有關。我想說，剩下的其實是脊椎和生物製劑渠道中斷。該價格主要包含在我們最初的指導中。它比我們原來的要陡峭一些，但我想說這是我們原來的指南中的內容。我們確實看到了——是的，我們確實在第一季採取了一些措施，包括價格和分銷管道的疲軟。我們確實在第一季看到了一些這樣的情況，但我們預計大部分情況將出現在第二季。

And then if you think about the $5 million from NGO that was -- they generally placed a quarterly order, so that's going to spread evenly throughout the year. So we had $1.5 million or so of that in Q1, and you'll see that throughout the remainder of each year, each quarter of this year for that as well as far as we are aware at this point.

然後，如果你想想非政府組織提供的 500 萬美元——他們通常按季度下訂單，所以這筆錢會均勻分佈在全年。因此，我們在第一季獲得了大約 150 萬美元的收入，並且您將在今年剩餘時間、今年每個季度以及據我們目前所知的情況下看到這一數字。

Okay. And if I could just add, just to make sure I'm doing all that math right. I mean it sounds like the first quarter, if you add back the selling day difference, which I don't think we had contemplated and then some of those moving pieces, you're sort of excluding M6 still in the low 190s. Is that sort of the right way to think about it, if I just add back some of that.

好的。如果我可以補充的話，只是為了確保我所做的所有數學計算都是正確的。我的意思是，聽起來第一季度，如果你加上銷售日差異（我不認為這是我們曾經考慮過的），然後再加上一些變動部分，你就會排除仍然在 190 年代初期的 M6。如果我再添加一些內容，這是正確的思考方式嗎？

Yeah, that would be the right way to think about it, Matt.

是的，這是正確的思考方式，馬特。

Okay. Thank you very much. I'll get back in queue.

好的。非常感謝。我會回到隊列中。

Caitlin Conan, Canaccord Genuities.

凱特琳柯南 (Caitlin Conan)，Canaccord Genuities。

(inaudible) taking the questions. I guess just to start off, just a quick clarifying question for the NGL impact, where is that going to hit specifically within the different segments? And then just with the guidance change, really, any thoughts on the longer-term guidance and the risk to that staying the same?

（聽不清楚）回答問題。我想首先，我們來快速澄清一下關於 NGL 影響的問題，它對不同細分市場的具體影響是什麼？那麼，隨著指導方針的改變，對於長期指導方針以及保持不變的風險，您有什麼看法？

Yeah. So the NGO business is ortho. So it will be in the international ortho business is where you would see that. And then we are not updating our long-term guidance at this point. we'll provide an update on our Q4 call.

是的。因此，非政府組織的業務是正統的。因此，您將在國際正畸業務中看到這一點。目前我們不會更新我們的長期指導。我們將在第四季電話會議上提供最新消息。

Okay. Great. And then just a follow-up. Any more color on 7D this quarter and kind of the capital environment?

好的。偉大的。然後只是後續行動。關於本季 7D 和資本環境還有什麼消息嗎？

Yeah. I mean we're still continuing to make progress with 7D. We're focused -- our focus is really on earn-out because we believe that is the best return for us in the long term with the [poultry] to our spine business but no specific updates as it relates to the capital environment.

是的。我的意思是我們仍在繼續推動 7D 的發展。我們專注於獲利，因為我們相信，從長遠來看，這是從家禽到脊椎業務的最佳回報，但沒有與資本環境相關的具體更新。

Great. Thanks.

偉大的。謝謝。

(Operator Instructions)

（操作員指示）

Jeffrey Cohen, Ladenburg.

傑弗裡·科恩，拉登堡。

Good morning. Thanks for taking our questions. I guess two for me. I guess firstly, could you talk about AccelStim 2.0 a little bit. We're particular on timing, but could you talk about some of the functionality that's available on the unit? And could you talk about the form factor and manufacturing (inaudible) Thanks.

早安.感謝您回答我們的問題。我想對我來說是兩個。首先，您能否簡單談談 AccelStim 2.0。我們對時間很講究，但您能談談該設備上的一些功能嗎？您能談談外形尺寸和製造嗎（聽不清楚）謝謝。

Look, AccelStim 2.0, what it does, it pretty much connections to our -- our physician portal STIM onTrack. So it's going to do what all of the other systems that we sell -- do. So give the opportunity to the surgeon to keep follow the patient during the utilization of the device to make sure that the patient is compliant and the monitor progress. So I think that this one is going to help us because it give -- like it's something that also the physician can bill, it can -- given that there is a DRG code for it. So I get the opportunity for us to keep pushing into the specific market segment.

看看 AccelStim 2.0，它的作用是，它與我們的——我們的醫生門戶 STIM onTrack 緊密相連。因此它將實現我們銷售的所有其他系統所實現的功能。因此，讓外科醫生有機會在使用該設備期間持續追蹤患者，以確保患者順從並監測進展。所以我認為這對我們有幫助，因為它可以提供——就像它是醫生可以計費的東西，它可以——因為它有一個 DRG 代碼。因此，我獲得了我們繼續進入特定細分市場的機會。

So there won't be any change as far as the functionality in the settings of the actual unit?

那麼就實際單元的設定功能而言不會有任何變化嗎？

No. It's just the integration with STIM onTrack.

不。它只是與 STIM onTrack 的整合。

Got it. Perfect. Okay. And (inaudible) you talk about the TrueLok system a little bit as far as the cases that's been done. What's being measured as far as data and outcomes? And how many SKUs would you ambition having when launching this year?

知道了。完美的。好的。而且（聽不清楚）您就已完成的案例稍微談一下 TrueLok 系統。就數據和結果而言，要測量什麼？今年推出時您希望有多少個 SKU？

Yeah. So the SKUs of the TrueLok TBT is pretty much similar to all our other systems. So it pretty much is one SKU with some accessories. And right now, we are in a limited clinical release that is doing very well. So we are having a lot of interest of surgeons that are going to help us to collect data to demonstrate the benefit of our -- of this new -- of this technique. There are already a good amount of literature available about the benefit.

是的。因此，TrueLok TBT 的 SKU 與我們所有其他系統非常相似。因此它基本上是一個帶有一些配件的 SKU。目前，我們正在進行有限的臨床發布，並且進展順利。因此，我們吸引了大量外科醫生的關注，他們將幫助我們收集數據，以證明這項新技術的益處。目前已有大量關於該益處的文獻。

But of course, we want to make sure that we keep pushing this highly differentiable procedure that can help us to enter a market segment that is pretty large. And also, as said, there are 160,000 amputations that are happening in United States because of diabetes, because of diabetic food. And we think that this procedure can be game changing. So something that we are very excited about. And like I said, already, we did that in cases just in a very limited market release. So a great opportunity for us.

但當然，我們希望確保繼續推動這個高度差異化的程序，以幫助我們進入一個相當大的細分市場。而且，正如所說，美國有 16 萬例截肢手術是因糖尿病和糖尿病食品而發生的。我們認為這一程序可以改變遊戲規則。所以我們對此感到非常興奮。正如我所說的，我們只是在非常有限的市場發布中做到了這一點。這對我們來說是一個很好的機會。

Perfect. Thank you for taking my questions.

完美的。感謝您回答我的問題。

There are no further questions at this time. I will now turn the call back over to Julie Dewey for closing remarks.

目前沒有其他問題。現在我將把電話轉回給朱莉·杜威 (Julie Dewey) 做結束語。

Thanks, everybody, for joining us today. We appreciate your time and interest. If you have more questions, please reach out, and we look forward to talking to you next quarter. This concludes our call.

感謝大家今天加入我們。我們感謝您的時間和關注。如果您有更多問題，請聯絡我們，我們期待下個季度與您交談。我們的通話到此結束。

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝大家的加入。您現在可以斷開連線。