使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good afternoon, and welcome to SIâBONEâs first-quarter 2026 earnings conference call. At this time, all participants are in a listenâonly mode. We will be facilitating a questionâandâanswer session toward the end of todayâs call. As a reminder, this call is being recorded for replay purposes.
下午好,歡迎參加 SIâBONE 2026 年第一季財報電話會議。目前所有與會者皆處於僅收聽模式。我們將在今日電話會議接近尾聲時進行問答環節。提醒各位,本次電話會議將錄音以供重播。
I would now like to turn the call over to Saqib Iqbal, Vice President, FP&A and Investor Relations at SI-BONE for a few introductory comments.
現在我想把電話會議交給 SI-BONE 財務規劃與分析(FP&A)暨投資人關係副總裁 Saqib Iqbal,請他先做幾點開場說明。
Saqib Iqbal - Vice President, Financial Planning & Analysis and Investor Relations
Saqib Iqbal - Vice President, Financial Planning & Analysis and Investor Relations
Earlier today, SIâBONE released financial results for the quarter ended March 31, 2026. A copy of the press release is available on the companyâs website.
今天稍早,SIâBONE 已公布截至 2026 年 3 月 31 日止季度的財務結果。新聞稿副本可於公司網站取得。
Before we begin, Iâd like to remind you that managementâs remarks today may include forwardâlooking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forwardâlooking statements are subject to a number of risks and uncertainties, including those set forth in our SEC filings, such as our most recent Form 10âK, and actual results may differ materially from any forwardâlooking statements that we make today. Accordingly, you should not place undue reliance on these statements. These forwardâlooking statements speak only as of the date that they are made, and we do not assume any obligation to update any forwardâlooking statements, except as required by law.
在開始之前,我想提醒各位,管理層今天的發言可能包含依據聯邦證券法所定義的前瞻性陳述,並係依據 1995 年《私人證券訴訟改革法》(Private Securities Litigation Reform Act of 1995)的安全港條款作出。這些前瞻性陳述受到多項風險與不確定性影響,包括我們向美國證券交易委員會(SEC)提交之文件(例如最近一期 Form 10âK)中所載者;實際結果可能與我們今天所作的任何前瞻性陳述存在重大差異。因此,您不應過度依賴這些陳述。這些前瞻性陳述僅反映其作出當日的情況,除法律要求外,我們不承擔更新任何前瞻性陳述的義務。
During the call, management may also discuss certain nonâGAAP measures, including adjusted EBITDA and free cash flow. Unless otherwise noted, any reference to profitability is in terms of positive adjusted EBITDA. For a reconciliation of these nonâGAAP measures to GAAP accounting, please see the companyâs full earnings release issued earlier today. Unless otherwise noted, all results are compared to the comparable period in the prior year.
在本次電話會議中,管理層也可能討論若干非 GAAP 指標,包括調整後 EBITDA 與自由現金流。除非另有說明,任何對獲利能力的提及均係以調整後 EBITDA 為正為準。如需將這些非 GAAP 指標與 GAAP 會計口徑進行調節,請參閱公司今天稍早發布的完整財報新聞稿。除非另有說明,所有結果均與去年同期的可比期間相比。
With that, Iâll return the call over to Laura.
接下來,我把電話會議交回給 Laura。
Laura Francis - Chief Executive Officer, Director
Laura Francis - Chief Executive Officer, Director
Thanks, Saqib. Good afternoon, and thank you for joining us. In the first quarter, we advanced our platform strategy on multiple fronts. Underpinning these strategic priorities is our clear focus on developing disruptive technologies that address unmet clinical needs for our surgeons and interventionalists when treating patients with compromised bone. Our technologies are differentiated in how they uniquely adhere to lowâdensity bone to enable more durable fusion and better outcomes relative to the current standards of care.
謝謝你,Saqib。下午好,感謝各位加入我們。在第一季,我們在多個面向推進了平台策略。支撐這些策略重點的是我們明確聚焦於開發顛覆性技術,以滿足外科醫師與介入治療醫師在治療骨質受損患者時尚未被滿足的臨床需求。相較於現行照護標準,我們的技術差異化在於能以獨特方式附著於低密度骨,從而實現更持久的融合並帶來更佳的治療結果。
We have never been better positioned as we accelerate growth through 2026 and into 2027. Our raised fullâyear outlook reflects that confidence. To better frame our progress in the quarter, let me connect our recent activities around product launches and commercial partnerships to our overarching strategy. We are focused on expanding into highâvalue clinical segments, extending our leadership position across global markets, and doing so efficiently through our hybrid commercial model, including strategic collaborations.
在我們加速成長、貫穿 2026 年並延伸至 2027 年之際,我們的定位從未如此有利。我們上調的全年展望反映了這份信心。為了更好地呈現本季的進展,讓我把我們近期在產品上市與商業合作夥伴關係方面的活動,與我們的整體策略連結起來。我們聚焦於拓展高價值臨床細分領域、在全球市場延伸我們的領導地位,並透過混合式商業模式(包含策略性合作)以更高效率達成上述目標。
INTRA Ti, which was launched in the quarter, is not just an expansion of our SI joint portfolio. It's a deliberate focus to further build the interventional segment with a solution that aligns with the physician workflow and site of care while also providing another compelling solution for surgeons. In Europe, the introduction of TNT TORQ expands our pelvic trauma portfolio and builds on the success we're seeing with TORQ. In Australia, the launch of TORQ extends our leadership in SI joint fusion and gives us a beachhead in pelvic fixation. The recently announced partnership with Smith+Nephew enables us to broaden our access to trauma while keeping our direct team focused on driving depth and density in spine and interventional.
本季推出的 INTRA Ti,不僅是我們 SI 關節產品組合的擴充。這是我們有意識地聚焦於進一步打造介入治療領域:提供一項符合醫師工作流程與照護場域的解決方案,同時也為外科醫師提供另一個具吸引力的方案。在歐洲,TNT TORQ 的導入擴大了我們的骨盆創傷產品組合,並延續我們在 TORQ 上看到的成功。在澳洲,TORQ 的上市延伸了我們在 SI 關節融合的領導地位,並讓我們在骨盆固定領域建立灘頭堡。近期宣布與 Smith+Nephew 的合作夥伴關係,使我們得以擴大在創傷領域的觸及,同時讓我們的直營團隊持續專注於推動脊椎與介入治療領域的深度與密度。
In the quarter, our worldwide revenue was $52.6 million, representing over 11% growth. In the US, revenue was $49.3 million reflecting approximately 10% growth. International revenue for the quarter was $3.3 million, representing an impressive 34% growth. Our twoâyear stacked worldwide and US revenue growth of 18% highlights the durability of demand for our solutions. Importantly, this growth was delivered with strong operating discipline.
本季我們的全球營收為 5,260 萬美元,成長超過 11%。在美國,營收為 4,930 萬美元,約成長 10%。本季國際營收為 330 萬美元,呈現亮眼的 34% 成長。我們全球與美國市場兩年疊加的營收成長率為 18%,凸顯市場對我們解決方案需求的持久性。重要的是,這項成長是在強勁的營運紀律下達成的。
Our operating expenses grew just over 4%, significantly below revenue growth, reflecting nearly 2.5 times operating leverage. This demonstrates our ability to drive growth while progressing toward sustained profitability and cash flow generation. Before I provide an update on our strategic priorities, let me provide insight into the recently announced reimbursement proposal.
我們的營業費用僅成長略高於 4%,顯著低於營收成長,反映出接近 2.5 倍的營運槓桿。這顯示我們在推動成長的同時,也正朝向可持續的獲利能力與現金流創造邁進。在我更新我們的策略重點之前,先就近期宣布的給付(reimbursement)提案提供一些說明。
This will positively impact our spinopelvic market opportunity with Granite if finalized as proposed. As you may recall, last year, we have requested CMS to assign pelvic fixation procedures incorporating Granite to a higher severity level within existing DRGs. Based on analysis of the complexity and cost profile of these procedures, CMS has instead proposed creating a new DRG family for supporting extensive or complex spinal fusion procedures, including those that incorporate Granite. We appreciate the acknowledgment by CMS of the higher procedure complexity in cases where Granite is used. Overall, we believe the proposal more appropriately aligns reimbursement with the cost of these procedures.
若最終按提案內容定案,這將對我們以 Granite 為核心的脊椎—骨盆(spinopelvic)市場機會帶來正面影響。各位或許記得,去年我們曾要求 CMS 將納入 Granite 的骨盆固定手術,在既有 DRG 中歸類至更高嚴重度等級。基於對這些手術複雜度與成本結構的分析,CMS 反而提議建立一個新的 DRG 家族,用於支援廣泛或複雜的脊椎融合手術,其中包括納入 Granite 的手術。我們感謝 CMS 認可在使用 Granite 的案例中,手術複雜度更高。整體而言,我們認為該提案能更適切地使給付與這些手術的成本相匹配。
The increase in the average hospital payments under the proposed new DRGs could be as high as $50,000 per procedure, depending upon specifics of the patientâs diagnosis and severity. This reimbursement change would be effective October 1 of this calendar year. We believe this incremental reimbursement would support continued adoption of our differentiated technology and ensure patients, surgeons, and hospitals maintain longâterm access to Granite. It will remove cost as a potential objection and further substantiate Granite as the standard of care in spinopelvic procedures. Taken together, we made significant progress toward building a durable growth engine with record physician engagement, broadening procedural footprint, expanding commercial scale, and favorable reimbursement backdrop. This gives us confidence that we are positioned to accelerate our revenue growth going forward.
在所提議的新 DRG 下,平均每例手術的醫院給付增加幅度可能高達 50,000 美元,視患者診斷與嚴重程度等具體情況而定。此項給付變更將於本曆年 10 月 1 日生效。我們相信,這項增量給付將支持我們差異化技術的持續採用,並確保患者、外科醫師與醫院能長期取得 Granite。這將消除成本作為潛在反對理由,並進一步鞏固 Granite 作為脊椎—骨盆手術照護標準的地位。綜合而言,我們在打造可持續成長引擎方面取得了顯著進展,包括創紀錄的醫師參與度、擴大手術適用範圍、擴張商業規模,以及有利的給付環境。這讓我們有信心,相信我們已具備條件在未來加速營收成長。
Now I will highlight the progress we have made on our four key priorities: innovation and market development, physician engagement, commercial execution, and operational excellence. Starting with innovation and market development, we are a category leader in developing and commercializing differentiated procedural solutions for patients with compromised bone. To date, our focus on the sacroiliac joint across three distinct disease states has resulted in nearly 150,000 procedures and has established our deep competencies around enabling fixation and fusion of lowâdensity bone. We are now leveraging this biomechanical leadership and our proprietary technology to expand beyond the sacroiliac joint into high-value clinical adjacencies in musculoskeletal care with a focus on patients with compromised, often osteoporotic bone.
接下來我將重點說明我們在四項關鍵優先事項上的進展:創新與市場開發、醫師參與、商業執行,以及營運卓越。先從創新與市場開發談起,我們是為骨質受損患者開發並商業化差異化手術解決方案的類別領導者。迄今為止,我們聚焦於薦髂關節(sacroiliac joint),涵蓋三種不同疾病狀態,已累計近 150,000 例手術,並建立了在低密度骨上實現固定與融合的深厚核心能力。我們正運用這項生物力學領導地位與專有技術,將版圖從薦髂關節延伸至肌肉骨骼照護中高價值的相鄰臨床領域,聚焦於骨質受損、且往往為骨質疏鬆的患者。
With nearly 300,000 annual target procedures, fixation and fusion to treat SI joint dysfunction remains our largest opportunity. As we know, the sacrum has relatively low-density bone. We are the undisputed leader with multiple RCTs that demonstrate the effectiveness of our technologies in treating this disease state. We have the most comprehensive platform that includes technologies and placement trajectories to address patient concerns and physician preferences across all sites of service. The recent launch of INTRA Ti, our 3D titanium solution, further extends our leadership by combining the clinical benefits of metal implants with the speed and simplicity of what we call our intraâ or posterior approachâbased workflow.
每年近30萬例目標手術中,針對薦髂(SI)關節功能障礙的固定與融合仍是我們最大的機會。如我們所知,薦骨的骨質密度相對較低。我們憑藉多項隨機對照試驗(RCT)證實我們的技術在治療此疾病狀態上的有效性,穩居無可爭議的領導地位。我們擁有最全面的平台,涵蓋多種技術與植入軌跡,可在所有服務場域中回應病患疑慮並符合醫師偏好。近期推出的 INTRA Ti(我們的3D鈦金屬解決方案),透過結合金屬植入物的臨床效益與我們所稱的 intra(或後路入徑)為基礎之工作流程的速度與簡便性,進一步鞏固並延伸我們的領導地位。
Our intra platform is a crucial enabler of our strategy to drive strong adoption among our fastâgrowing base of interventionalists and accelerating our penetration in the ASC and OBL sites of care. With the ongoing migration of procedures to these settings of care, we see a significant untapped market opportunity and a long runway for sustained growth. Spinopelvic fusion is our fastestâscaling market. As life spans increase, we expect a rise in spinopelvic procedures for patients with boneâcompromising conditions like osteoporosis or osteopenia.
我們的 intra 平台是推動策略落地的關鍵推手,可在我們快速成長的介入治療醫師(interventionalists)基礎中帶動強勁採用,並加速我們在 ASC 與 OBL 照護場域的滲透。隨著手術持續移轉至這些照護場域,我們看見顯著的未被開發市場機會,以及可支撐長期持續成長的長跑道。脊柱—骨盆融合是我們擴張速度最快的市場。隨著壽命延長,我們預期針對骨質受損狀況(如骨質疏鬆或骨質減少)的病患,脊柱—骨盆相關手術將增加。
Building on the success of Granite, we're leveraging our expertise to develop targeted and competitively differentiated solutions that will complement Granite, address other areas of procedural failures, thereby improving outcomes for this growing patient population. Since the launch of Granite, our spinal pelvic revenue growth has meaningfully outpaced the broader deformity market growth rate, supported by strong physician adoption and compelling clinical outcomes. The superiority of Granite was reaffirmed in the 160-patient PAULA study published in March. The study demonstrated zero Granite breakage or pullout while delivering clinically meaningful improvements in both pain and disability scores at 12 months. Granite benefits from favorable reimbursement dynamics, including the existing transitional pass-through with zero device offset in the outpatient and ASC settings.
在 Granite 成功的基礎上,我們正運用專業能力開發具針對性且在競爭上差異化的解決方案,以補強 Granite、解決其他手術失敗環節,從而改善這個成長中病患族群的治療結果。自 Granite 上市以來,在強勁的醫師採用與具說服力的臨床結果支持下,我們的脊柱—骨盆營收成長顯著超越整體脊柱畸形市場的成長率。今年3月發表的160名病患 PAULA 研究再次確認了 Granite 的優越性。研究顯示 Granite 零斷裂、零拉出(pullout),並在12個月時於疼痛與失能評分上帶來具臨床意義的改善。Granite 亦受惠於有利的給付動態,包括在門診與 ASC 場域既有的過渡性加成給付(transitional pass-through),且裝置不需抵減(zero device offset)。
The new DRGs proposed by CMS also reinforce Granite's economic attractiveness in inpatient settings by providing enduring reimbursement for our hospital customers and providing a framework for our commercial payers to follow suit. With nearly 130,000 target procedures, intuitive surgeon workflow, superior clinical outcomes, and highly supported reimbursement, we believe that Granite, as well as our future platform technologies can potentially make the spinal pelvic fusion market our largest revenue contributor in the coming years. In pelvic trauma, the majority of our approximately 60,000 target procedures are to treat low-intensity sacral insufficiency fractures. Our iFuse TORQ TNT system is well-aligned with existing surgeon workflows, benefits from favorable reimbursement, including NTAP of over $4,000, and is supported by our strategic partnership with Smith+Nephew. With the strong reception for TNT in Europe, we expect the pelvic trauma market to be an attractive contributor to global growth.
CMS 提出的新 DRG 亦透過為我們的醫院客戶提供可持續的給付,並提供商業保險支付方可依循的框架,進一步強化 Granite 在住院場域的經濟吸引力。憑藉近13萬例目標手術、直覺的外科工作流程、優異的臨床結果,以及高度支持的給付環境,我們相信 Granite 以及我們未來的平台技術,可能在未來幾年使脊柱—骨盆融合市場成為我們最大的營收貢獻來源。在骨盆創傷方面,我們約6萬例目標手術中的大多數用於治療低能量的薦骨不全性骨折。我們的 iFuse TORQ TNT 系統與既有外科醫師工作流程高度契合,並受惠於有利的給付,包括超過4,000美元的 NTAP,且有我們與 Smith+Nephew 的策略合作夥伴關係支持。隨著 TNT 在歐洲獲得強勁回響,我們預期骨盆創傷市場將成為全球成長的具吸引力貢獻者。
Finally, our multi-year pipeline is also advancing ahead of plan, reinforcing our position as an innovation leader. Our third breakthrough device is advancing on schedule, verification and validation are nearing completion, and we're targeting a 510(k) submission in the early third quarter. We have clear line of sight to a commercial launch, which we expect to meaningfully expand our total addressable market, deepen engagement with our spine surgeons, and represent a significant new revenue driver over the next several years. This technology addresses a significant unmet need in spine surgery and is designed to deepen our platform's utility in procedures our surgeons are already performing.
最後,我們多年期的產品研發管線也正超前計畫推進,進一步鞏固我們作為創新領導者的地位。我們的第三項突破性器械正按進度推進,驗證與確效(verification and validation)接近完成,目標在第三季初提交 510(k)。我們對商業化上市有清晰可見的路徑,預期將顯著擴大我們的整體可服務市場(TAM)、深化與脊椎外科醫師的互動,並在未來數年成為重要的新營收驅動力。此技術針對脊椎手術中一項重大的未被滿足需求,並旨在提升我們平台在外科醫師既有手術中的實用性。
Now let's move on to physician engagement. We had over 1,650 active physicians in the quarter, representing more than 17% growth. This extends our track record of another quarter of double-digit growth across all call points, including spine, interventional, and trauma. Our expanding platform positions us to build cross-procedure relationships and increase the number of procedures performed per physician.
接下來談醫師互動。本季我們有超過1,650位活躍醫師,成長超過17%。這延續了我們在所有拜訪重點(call points)上又一季的雙位數成長紀錄,涵蓋脊椎、介入治療與創傷。我們持續擴張的平台使我們能建立跨手術的合作關係,並提高每位醫師執行的手術數量。
In the first quarter, physicians active in the current quarter and prior year grew faster than the overall base, reinforcing our ability to retain physician engagement while expanding their use of our platform. These physicians generated 3 times the case volume of new users, reinforcing the value of long-term deep engagement. We're also seeing continued progress in cross-procedure adoption. The number of physicians performing more than one procedure type increased 10% in the quarter compared to the prior-year period.
第一季中,本季與前一年皆為活躍的醫師,其成長速度快於整體基礎,強化了我們在擴大其平台使用的同時,仍能維持醫師黏著度的能力。這些醫師所帶來的病例量是新使用者的3倍,凸顯長期深度互動的價值。我們也持續看到跨手術採用的進展。本季執行超過一種手術類型的醫師人數,較去年同期增加10%。
Today, only 25% of physicians performing SI joint fusion utilize our platform across additional indications, highlighting a significant opportunity to expand within our existing base. With Granite and our upcoming technologies, we're well-positioned to accelerate that expansion.
目前,執行 SI 關節融合的醫師中,僅有25%會將我們的平台用於其他適應症,顯示在既有客戶基礎內仍有顯著的擴張機會。憑藉 Granite 與我們即將推出的技術,我們已具備加速擴張的有利位置。
Now let's turn to commercial execution. We ended the quarter with 89 quota-carrying territory managers. Annual revenue per territory was $2.2 million, reflecting 11% year-over-year growth. This marked the 14th consecutive quarter of double-digit territory productivity growth. Our hybrid sales model, which is comprised of the territory managers, territory representatives, and over 300 third-party agents, continues to be a competitive advantage. Our hybrid sales model has been particularly effective in expanding the reach of our direct sales force, especially in the spinal pelvic and pelvic trauma markets.
接著談商業執行。本季末我們共有89位具業績配額的區域經理(quota-carrying territory managers)。每個區域的年營收為220萬美元,年增11%。這是連續第14季區域生產力維持雙位數成長。我們的混合式銷售模式由區域經理、區域代表,以及超過300位第三方代理組成,持續是我們的競爭優勢。此混合式銷售模式在擴大我們直銷團隊觸及範圍方面特別有效,尤其是在脊柱—骨盆與骨盆創傷市場。
Our territory managers are considered clinical experts and thought leaders, and the hybrid approach allows them to prioritize engagement activities and maximize their impact in the field. With Smith+Nephew, we completed the first phase of field rollout in April and expect training and surgical capacity rollout to be substantially complete by the end of the second quarter. We anticipate revenue contribution to begin building in the third quarter and accelerate into the fourth quarter. This is consistent with how trauma volume seasonally concentrates in the back half of the year. While it's still early, the initial physician and field reception has been encouraging and will provide more specific updates as the partnership matures.
我們的區域經理被視為臨床專家與意見領袖,而混合式做法使他們能優先安排互動活動,並在第一線將影響力最大化。與 Smith+Nephew 合作方面,我們已於4月完成第一階段的前線推廣(field rollout),並預期訓練與手術量能的推進將在第二季末前大致完成。我們預期營收貢獻將自第三季開始逐步建立,並在第四季加速。這也符合創傷手術量在季節性上集中於下半年之特性。雖然目前仍在早期階段,但初期醫師與前線回饋令人鼓舞;隨著合作關係成熟,我們將提供更具體的更新。
Finally, we remain on track to expand to approximately 100 territories over the next 12 months, aligning our commercial capacity with our strategy to bring several unique platform technologies to the market in the coming years.
最後,我們仍按計畫在未來12個月內將版圖擴展至約100個區域,使我們的商業量能與策略一致,以在未來幾年將多項獨特的平台技術推向市場。
Before I turn the call over to Anshul, I want to thank our employees for their continued focus and execution. We built one of the fastest-growing differentiated technology platforms with deep expertise in addressing the needs of patients with compromised bone. That focus continues to guide our innovation and expansion into new indications that will improve the lives of hundreds of thousands of patients over the next several years. The fundamentals of this business across physician engagement, commercial productivity, and a broadening innovation pipeline give us real conviction in the trajectory ahead.
在我把電話會議交給 Anshul 之前,我要感謝我們的員工持續專注並確實執行。我們打造了業界成長最快之一、具差異化的技術平台,並在滿足骨質受損病患需求方面擁有深厚專業。這份專注持續引導我們創新,並拓展至新的適應症,預期在未來幾年改善數十萬名病患的生活。在醫師互動、商業生產力,以及日益擴大的創新研發管線等面向的基本面,讓我們對未來發展軌跡具備堅定信心。
Anshul will now take you through the fourth priority of operational excellence, as well as provide financial details and our updated guidance, which reflects that confidence.
接下來 Anshul 將帶各位說明第四項優先事項:營運卓越,同時提供財務細節與我們更新後的財測指引,以反映這份信心。
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Thanks, Laura. Good afternoon, everyone. My comments today will focus on first quarter revenue growth, profitability, and liquidity. All of the comparisons provided will be versus the same period in the prior year, unless noted otherwise. Starting with revenue growth, our worldwide revenue was $52.6 million, representing growth of 11.2%. US revenue was $49.3 million, increasing 10%, even with the stronger priorâyear comparison that benefited from three product launches.
謝謝你,Laura。各位下午好。我今天的評論將聚焦於第一季營收成長、獲利能力與流動性。除非另有說明,以下所有比較皆以去年同期為基準。先從營收成長談起,我們的全球營收為5,260萬美元,成長11.2%。美國營收為4,930萬美元,成長10%,即使去年同期的比較基期較強,且受惠於三項產品上市。
The first quarter performance was modestly impacted by weatherârelated disruptions early in the quarter and our decision to deliberately pace from distributor onboarding while finalizing the Smith+Nephew partnership. Revenue momentum accelerated as the quarter progressed, driven by expanding adoption of the portfolio by a record number of physicians across all sites of service. International revenue was $3.3 million, increasing an impressive 33.9%, reflecting accelerating demand for iFuse TORQ across Europe and Australia. This trend, combined with the early enthusiasm for iFuse TORQ TNT in Europe, reinforces our confidence in the significant longâterm opportunity across our international markets.
第一季表現受到季初天候相關干擾的些微影響,以及我們在完成Smith+Nephew合作夥伴關係之際,決定刻意放慢經銷商導入節奏。隨著季度推進,營收動能加速,主要由於在所有服務場域中,創紀錄數量的醫師擴大採用我們的產品組合所帶動。國際營收為330萬美元,大幅成長33.9%,反映iFuse TORQ在歐洲與澳洲的需求加速。此趨勢,加上歐洲市場對iFuse TORQ TNT的早期熱烈反應,強化了我們對國際市場長期重大機會的信心。
Moving to profitability, our gross profit was $41.9 million, an increase of $4.2 million, or 11.3%. Our gross margin for the quarter was flat year over year at 79.8% and remains among the best in the industry. Betterâthanâanticipated ASP from a favorable procedure mix, alongside the sustained impact of our operational efficiency initiatives, contributed to the strong gross margins in the quarter. Operating expenses were $47.0 million, representing 4.1% growth.
接著談獲利能力,我們的毛利為4,190萬美元,增加420萬美元,或成長11.3%。本季毛利率年對年持平為79.8%,仍為業界最佳之一。受惠於有利的手術組合帶來優於預期的平均銷售價格(ASP),以及我們營運效率提升措施的持續成效,共同支撐本季強勁的毛利率表現。營業費用為4,700萬美元,成長4.1%。
The modest increase was driven by higher commissions tied to revenue growth, as well as targeted investments in training, marketing investment to support the INTRA Ti launch, and ongoing investment in the product pipeline. The combination of strong revenue growth and operating discipline continues to drive meaningful operating leverage in the business. Our net loss narrowed to $4.3 million, or $0.10 per diluted share, compared to a net loss of $6.5 million, or $0.15 per diluted share, representing strong yearâoverâyear progress. Adjusted EBITDA was $2.5 million in the quarter, representing over 440% improvement compared to $0.5 million in the first quarter of 2025. We are pleased with the expanding profitability, even as we prioritize investments in innovation and commercial expansion.
這項溫和的增加主要來自與營收成長連動的較高佣金,以及在訓練、支援INTRA Ti上市的行銷投入,與產品研發管線的持續投資等精準投資。強勁的營收成長與營運紀律的結合,持續為公司帶來顯著的營運槓桿。我們的淨損收斂至430萬美元,或每股稀釋後虧損0.10美元;相較去年同期淨損650萬美元,或每股稀釋後虧損0.15美元,年對年進展顯著。本季調整後EBITDA為250萬美元,較2025年第一季的50萬美元改善超過440%。即使我們仍優先投入創新與商業擴張,我們對獲利能力的擴張感到滿意。
Turning to liquidity, we exited the quarter with $144.7 million in cash and marketable securities, providing us with significant financial flexibility. Free cash flow in the first quarter was only negative $3.4 million, representing a 50.7% improvement compared to the priorâyear period. As a reminder, firstâquarter cash usage reflects the seasonal impact of fourthâquarter commission trueâups and annual bonus payouts. We do expect to see higherâthanânormal cash flow variability in the second and third quarters, driven by the timing of payments for buildout of a new headquarters which is expected in the second quarter and the timing of tenant improvement allowance reimbursements.
再來談流動性,我們在季度末持有現金與有價證券1億4,470萬美元,為我們提供了顯著的財務彈性。第一季自由現金流僅為負340萬美元,較去年同期改善50.7%。提醒各位,第一季的現金使用反映第四季佣金結算調整(true-ups)與年度獎金發放的季節性影響。我們預期第二與第三季的現金流波動將高於正常水準,主要受新總部建置付款時點(預計在第二季)以及租戶裝修補助(tenant improvement allowance)報銷時點的影響。
Our balance sheet, combined with progress toward free cash flow breakâeven, positions us well to both invest and scale profitably. We have the liquidity to accelerate R&D investments and expand our commercial infrastructure to support multiple product launches over the next five years.
我們的資產負債表,加上朝向自由現金流損益兩平的進展,使我們具備良好條件,既能投資也能以獲利方式擴張規模。我們具備充足流動性,可加速研發投資並擴大商業基礎建設,以支援未來五年多項產品上市。
Now, turning to our updated outlook for 2026, we are increasing our fullâyear revenue guidance to a range of $230 million to $233 million. The updated guidance implies yearâoverâyear growth of approximately 14% to 16%. We expect quarterly yearâoverâyear revenue growth to accelerate as we progress through the year driven by the impact of the strategic innovation, commercial expansion, and geographic initiatives we highlighted today. We are still in the early stages of realizing the full benefit of these efforts, which we believe could represent a meaningful source of potential outperformance in the second half of 2026 and going into 2027. As their impact increases, we appropriately reflect that upside in our guidance.
接著談我們對2026年的最新展望,我們將全年營收指引上調至2億3,000萬至2億3,300萬美元。更新後的指引意味著年對年成長約14%至16%。我們預期隨著年度推進,季度年對年營收成長將加速,主要由我們今天強調的策略性創新、商業擴張與地理布局措施所帶動。我們仍處於充分實現這些努力效益的早期階段;我們相信,這些措施可能在2026年下半年及進入2027年時,成為具意義的潛在超預期來源。隨著其影響力提升,我們也在指引中適度反映這項上行空間。
We are also raising our annual gross margin expectations to approximately 79%, up 100 basis points from our prior guidance. This reflects the favorable procedure mix and the sustained impact of our operational efficiency initiatives. Taken together, both raises reinforce our conviction that the business is performing at a high level and that our path to expanding profitability is on track. We expect full-year operating expenses to grow approximately 12.5% at the midpoint of our revenue guidance. We believe this disciplined investment will further strengthen our competitive position and facilitate sustained longâterm growth.
我們也將全年毛利率預期上調至約79%,較先前指引提高100個基點。這反映有利的手術組合,以及我們營運效率提升措施的持續成效。綜合而言,這兩項上調強化了我們的信念:公司營運表現維持高水準,且擴大獲利能力的路徑正按計畫推進。我們預期全年營業費用在營收指引中位數下約成長12.5%。我們相信這種有紀律的投資將進一步強化競爭地位,並促進可持續的長期成長。
With that, I will turn the call over to Laura.
接下來,我把電話交給Laura。
Laura Francis - Chief Executive Officer, Director
Laura Francis - Chief Executive Officer, Director
Thanks, Anshul. Before we go to Q&A, let me leave you with a few proof points that define our stellar execution track record: 20 consecutive quarters of doubleâdigit physician growth and a record 1,650 active physicians in the first quarter, 14 consecutive quarters of doubleâdigit territory productivity growth, improving profitability and free cash flow trajectory, guidance raised after the first quarter with revenue growth accelerating as we progress through the year, and a third breakthrough device on track for launch in the fourth quarter. We have built something durable and scalable here, and we are excited about what comes next.
謝謝你,Anshul。在進入問答之前,我想用幾個佐證重點來說明我們卓越的執行紀錄:醫師數連續20個季度維持雙位數成長,且第一季活躍醫師數創紀錄達1,650位;區域生產力連續14個季度維持雙位數成長;獲利能力與自由現金流走勢持續改善;第一季後上調指引,且隨著年度推進營收成長加速;以及第三項突破性器械按計畫將於第四季上市。我們在此建立了具耐久性且可擴展的事業,我們也對接下來的發展感到振奮。
With that, we are happy to answer your questions. Operator?
那麼,我們很樂意回答各位的問題。接線員?
Operator
Operator
(Operator Instructions) Matthew OâBrien, Piper Sandler.
(接線員指示) Matthew O’Brien,Piper Sandler。
Matthew OâBrien - Analyst
Matthew OâBrien - Analyst
Just Anshul, can you quantify the weather impact in the quarter? Then I guess the top end of the guide was only raised by about $500,000. The bottom end came up by $1.5 million. Why not take it up a little bit more? Just is there anything to read into that? Then I do have a follow-up.
Anshul,能否量化一下本季天候影響?另外我想,指引上緣只上調了大約50萬美元。下緣則上調了150萬美元。為什麼不再多上調一些?這當中是否有什麼訊息可以解讀?我還有一個追問。
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
One, we're really pleased with how the business performed in the quarter. We saw, like I said in my prepared remarks, the acceleration in revenue as we progressed through the quarter. And that trend continued into April, so very, very encouraged there. In terms of the weather-related impact in January, I would say it's circa in the $0.5 million range, but a lot of that gets recaptured. If you go back in time, even during the pandemic or other disruptions, it generally takes about 60 days or so for those procedures to get rescheduled. So I'd say the impact for the quarter was pretty muted. It was just timing between month one and later, so that's there.
第一,我們對本季業務表現非常滿意。正如我在事先準備的發言中提到的,我們看到營收隨著季度推進而加速。而且這個趨勢延續到四月,所以我們非常、非常受到鼓舞。就一月的天候相關影響而言,我會說大約在50萬美元左右,但其中相當一部分會被追回。如果回顧過去,即便在疫情或其他干擾期間,通常大約需要60天左右,這些手術就會被重新安排。因此我會說本季的影響相當有限。主要只是第一個月與之後月份之間的時點差異,就是這樣。
In terms of our guidance, look, again, we raised the lower end of the guide by a $1.5 million, the upper end by $0.5 million, so the midpoint's going up about $1 million. That's pretty consistent with our disciplined approach to guidance, especially this early in the year. Laura highlighted several of the initiatives that we've been focused on in Q1, and we know that there is potential upside there, especially when you think about the potential opportunity for our INTRA Ti product as we expand into interventional. The potential for Smith+Nephew partnership as it gets seasoned in the back half of the year. And then you've got a couple other nice tailwinds around the potential higher DRG reimbursement that could go into effect on October 1.
就我們的財測指引而言,你看,再次強調,我們把指引下緣上調了150萬美元、上緣上調了50萬美元,因此中點大約上升了100萬美元。這與我們對指引採取的審慎、紀律化作法相當一致,尤其是在年度這麼早的時點。Laura 已經強調了我們在第一季聚焦的幾項舉措,我們也知道其中存在潛在上行空間,特別是當你想到我們的 INTRA Ti 產品在我們擴展至介入式領域時所帶來的潛在機會。以及 Smith+Nephew 合作夥伴關係在今年下半年逐步成熟後的潛力。另外,還有幾個不錯的順風因素,包括可能提高的 DRG 給付補償,可能會在 10 月 1 日生效。
That could be a really nice tailwind for our Granite business, which has been scaling really well. And then you've got a full third BDD product that we're going to launch out in the fourth quarter. So there's a lot of tailwinds in the business, but given that we're early in the year, a lot of these tailwinds are still preliminary. We want to grow into those and then reflect that upside in our updated guidance as we go through the year.
這可能會成為我們 Granite 業務非常好的順風因素,而該業務的規模化進展非常順利。此外,我們還有第三個 BDD 產品,預計在第四季推出。所以業務上有很多順風因素,但鑑於現在仍在年初,這些順風因素多數仍屬初期階段。我們希望先把這些順風因素轉化為實際成長,並在年度推進過程中,於更新指引時反映這些上行空間。
Matthew OâBrien - Analyst
Matthew OâBrien - Analyst
Got it. Appreciate that. And then Laura, thanks for the update on the new product that's coming out, relatively soon that has Breakthrough Device Designation. You said Q2 filing. Is it too aggressive to think that we may be able to see that at NASS this year, or NASS/see it/launch it, or should we really expect more of a launch '27?
了解。謝謝你的說明。另外 Laura,謝謝你更新即將推出、且獲得「突破性醫療器材認定」(Breakthrough Device Designation)的新產品進度。你提到第二季送件申請。如果我們期待今年在 NASS 看到它,或在 NASS 亮相/並推出,這樣會不會太積極?還是我們應該更預期在 2027 年才會推出?
Laura Francis - Chief Executive Officer, Director
Laura Francis - Chief Executive Officer, Director
What we said is that we will have a Q3 filing, and that we expect for the product to launch sometime in the fourth quarter based on based on that timing. As soon as we have a product, we will be bringing that product to various conferences. NASS may be a little bit early in the year for us to talk about it, but regardless, we're very excited. It is our third breakthrough device. We believe that we're addressing the largest unmet clinical need with our spine surgeons, and so we really think that we're on a good trajectory with that product.
我們說的是第三季送件申請,並且基於這個時程,我們預期產品會在第四季的某個時間點上市。一旦我們有了產品,我們就會把它帶到各種會議上展示。NASS 對我們來說可能稍微早了一點,未必適合在那時談太多,但無論如何,我們都非常興奮。這是我們第三個突破性器材。我們相信,我們正在針對脊椎外科醫師所面臨的最大未被滿足的臨床需求,因此我們認為這個產品的發展軌跡非常良好。
Also, we think it's going to provide a really nice opportunity for us to increase surgeon density as well. Last year, we had over 2,400 physicians who did at least one case with us, and so we have a very significant size customer base in order to utilize that product. And we believe that that product may be used in the same cases as Granite as well. And given the new DRG as well and that product being used in those cases, it provides this opportunity not just to open up a new TAM for us, but also to increase our surgeon density in a significant way. As soon as we have a clearance, you're going to know about it and you're going to see the product, but we're incredibly excited about it and what it can bring to us late this year and certainly into 2027.
另外,我們也認為這將為我們提供一個很好的機會,進一步提升外科醫師密度。去年有超過 2,400 位醫師至少與我們合作完成過一例手術,因此我們擁有相當可觀的客戶基礎可用來導入該產品。我們也相信,該產品可能會在與 Granite 相同的病例中使用。再加上新的 DRG,以及該產品在這些病例中的使用,這不僅讓我們有機會開拓新的 TAM(可服務市場),也能以顯著方式提升我們的外科醫師密度。一旦取得核准,你們就會知道、也會看到產品;我們對它以及它在今年稍晚、並且延伸到 2027 年能帶來的貢獻感到非常興奮。
Operator
Operator
Young Li, Jefferies.
Young Li,Jefferies。
Young Li - Analyst
Young Li - Analyst
I guess to start, just curious, I mean, there's a lot of momentum in the business. There's going to be a new product launching that's going to be impacting growth next year. There's reimbursement tailwinds. You're adding new territories and expanding commercial scale. I guess the question is, can '27 growth be higher than '26 growth or exit rate growth?
我想先從一個問題開始:我很好奇,業務動能看起來很強。明年會有一個新產品上市,將影響成長。也有給付補償的順風因素。你們正在新增銷售區域並擴大商業化規模。問題是:2027 年的成長是否可能高於 2026 年的成長,或高於退出時的成長率?
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Happy to take that. Just even thinking about how we've set expectations for the rest of the year 2026, we do believe there is potential for significant upside as those tailwinds start having a more meaningful impact as we progress through the year. That's embedded in our statement around year-over-year growth acceleration in each of the subsequent quarters. We feel very good about that now.
我很樂意回答這個問題。即便只看我們對 2026 年剩餘期間的預期設定,我們確實認為,隨著這些順風因素在年度推進中開始產生更具實質的影響,仍存在顯著上行空間。這也反映在我們所提到的:後續每一季的年對年成長都將加速。我們目前對此感到非常有信心。
In terms of talking about exit growth rates, again, as revenue growth accelerates, I think that would be a nice off-ramp for 2027, and that's just seeing the initial impact of these tailwinds. So I'm not going to provide context on where 2027 could go, but let me just provide some quantitative color that will help you understand the secular tailwinds in the business, which are actually long-term, not specific to just 2026.
至於談退出時的成長率,再次強調,隨著營收成長加速,我認為這會為 2027 年提供一個不錯的銜接坡道,而那只是這些順風因素初步影響的開始。因此我不會提供 2027 年可能走向的具體情境,但我可以補充一些量化資訊,幫助你理解業務中的結構性順風因素;這些其實是長期的,不僅僅是 2026 年。
Within SI joint fusion, our interventional strategy is in the early innings with the increase in reimbursement for OBL, our IntraX products doing really well there. Intra Ti just launched, and we're seeing rapid pace of adoption across our Intra family and which should only accelerate going into 2027. On the pelvic fixation side, Granite has scaled up really well with the potential for the new DRGs going into effect on October 1. You obviously will have an impact in the fourth quarter, but a more pronounced impact as you go into next year as well.
在 SI 關節融合方面,我們的介入式策略仍在早期階段;隨著 OBL 給付補償提高,我們的 IntraX 產品在那裡表現非常好。Intra Ti 剛上市,我們看到 Intra 產品家族的採用速度很快,而這在邁向 2027 年時應該只會進一步加速。在骨盆固定方面,Granite 的規模化進展非常順利,且新的 DRG 有可能在 10 月 1 日生效。這顯然會在第四季產生影響,但進入明年後影響會更為明顯。
And then when you layer on that new product Laura just talked about, it also provides an opportunity for a higher procedure ASP because that new product alongside Granite can go into the same product. And then on the pelvic trauma side, with Smith+Nephew, as we go through the year and we start seeing that relationship mature, we're going to continue to put surgical capacity out there in 2027 as well, given the breadth of trauma, level 1, level 2 trauma sites we're targeting. So I think that should be a nice tailwind too.
此外,當你把 Laura 剛提到的新產品也納入考量,它也帶來提高單次手術 ASP(平均銷售價格)的機會,因為該新產品可與 Granite 一起用於同一個手術中。再來在骨盆創傷方面,與 Smith+Nephew 的合作,隨著年度推進、關係逐步成熟,我們在 2027 年也會持續擴充手術量能,因為我們鎖定的創傷中心涵蓋廣泛,包括第一級、第二級創傷醫院。所以我認為這也會是一個不錯的順風因素。
And then there's international. You've got TNT that just got commercialized in Europe. That's about, I'd say, nine months ahead of schedule. We were hoping to commercialize it in 2027. So as that gets seasoned, that will be a nice tailwind as well.
另外還有國際市場。TNT 剛在歐洲完成商業化。我會說這大約比原計畫提前了九個月。我們原本希望在 2027 年才完成商業化。因此,隨著它逐步成熟,這也會成為一個不錯的順風因素。
So I think there's a lot of positive long-term secular tailwinds in the business that extend beyond '26 into '27. But again, consistent with how we think about the business, we want to execute through 2026, grow into those tailwinds, and then be able to articulate what that exit ramp translates into 2027 growth.
所以我認為,業務中有很多正向、長期的結構性順風因素,會從 2026 年延伸到 2027 年。但再次強調,依照我們看待業務的方式,我們希望先在 2026 年把執行做好、把這些順風因素轉化為成長,然後再能清楚說明這個退出坡道在 2027 年會轉化為怎樣的成長。
Young Li - Analyst
Young Li - Analyst
All right. That's very helpful. Just on the revenue per rep or trailing 12 months, still seeing pretty solid double-digit growth there. Just curious where do you think that can continue to grow to? Where does it cap out at, especially with the contributions from the Smith+Nephew relationship as well as the new territories you are adding?
好的。這非常有幫助。關於每位業務代表的營收或過去 12 個月(TTM),目前仍看到相當穩健的雙位數成長。我想請教你認為這還能持續成長到什麼程度?它的上限大概在哪裡,特別是考量 Smith+Nephew 合作關係的貢獻,以及你們正在新增的新銷售區域?
Laura Francis - Chief Executive Officer, Director
Laura Francis - Chief Executive Officer, Director
You're right. We have continued to see those productivity gains over the last three years. I think that we've doubled in terms of sales rep productivity. A lot of that did come from the hybrid model that we have in place, where it's the territory managers that carry the quota, those 89 people that we ended with at the end of Q1, supported by our more junior territory reps, but then also the over 300 third-party agents that we're working with. With that said, the $2.2 million, I do not think that that's a cap. Our largest territories are more than double that size. So we have examples where we have much higher productivity in the field, so those are the examples that we're using for best practices.
你說得對。過去三年我們持續看到這些生產力提升。我認為就銷售代表生產力而言,我們已經翻倍。其中很大一部分確實來自我們目前採行的混合模式:由負責配額的區域經理承擔(第一季末我們共有89位),並由較資淺的區域業務代表支援,另外還有我們合作的300多位第三方代理商。話雖如此,我不認為220萬美元是一個上限。我們最大的區域規模是其兩倍以上。因此我們有一些例子顯示外勤端的生產力更高,這些就是我們用來作為最佳實務的範例。
With that said, we do target to get to nearly 100 territories over the next 12 months. We want to capitalize on the current demand that we have and also all of the discussion that we just had around upcoming launches at the end of 2026 and then into 2027 is really important. But you're also right that the growth is not solely dependent on the territory count. The expected ramp with Smith+Nephew, that partnership there is going to provide an opportunity for us specifically in trauma while allowing our sales reps to focus on spine and interventional.
話雖如此,我們的目標是在未來12個月內將區域數提升到接近100個。我們希望把握目前的需求,同時我們剛才討論到的、在2026年底以及2027年將推出的新產品,確實非常重要。但你也說得對,成長並不完全取決於區域數量。與Smith+Nephew的預期爬坡(ramp)以及該合作夥伴關係,將特別在創傷領域為我們帶來機會,同時讓我們的銷售代表能專注於脊椎與介入式業務。
So overall, I think the way that we're growing the territories, as you can see, we've gotten significant operating leverage, but our goal is to continue to drive growth and penetration with our current customers and potential new customers.
總體而言,我認為從我們擴增區域的方式來看,如你所見,我們已取得顯著的營運槓桿;但我們的目標是持續推動成長,並提升在現有客戶與潛在新客戶中的滲透率。
Operator
Operator
Matt Blackman, TD Cowen.
Matt Blackman,TD Cowen。
Drew Ranieri - Analyst
Drew Ranieri - Analyst
It's Drew on for Matt tonight. Laura, maybe just for you to start, I think in your prepared remarks, you said the spinopelvic fusion market or opportunity could be your largest contributor over the next few years. Can you maybe dive into that a little bit more? Do you need the breakthrough? Does it need the device, the third one, to really drive the bulk of that aspiration? Or is there more in the pipeline that's really needed for that to occur? Maybe just help us size the Granite revenue contribution today so we might be able to better appreciate the opportunity ahead.
今晚由Drew代替Matt發問。Laura,先請教你:我記得你在事先準備的發言中提到,脊骨盆融合(spinopelvic fusion)市場或機會在未來幾年可能會成為你們最大的貢獻來源。你能否再深入說明一下?你們是否需要那個突破性產品?是否需要那個裝置(第三個產品)才能真正推動你們所期望的大部分成長?或者還需要更多產品管線才能實現?另外,也請協助我們了解Granite目前的營收貢獻規模,讓我們能更好地評估未來的機會。
Laura Francis - Chief Executive Officer, Director
Laura Francis - Chief Executive Officer, Director
Yes, we are pretty excited about the opportunity in spinopelvic. As I mentioned, we worked with over 2,400 physicians last year, most of those spine surgeons, and they're doing SI joint fusion procedures, and more and more often they're doing Granite procedures. So in terms of the comment that was made that this could be our largest market, it does take into consideration the continued growth opportunity with Granite, especially supported by the new DRGs effective in October of this year. We think that's going to have a significant impact, taking cost away from the conversation that we have with hospitals, and really helping to support Granite as the standard of care in spinopelvic fixation. That's number one.
是的,我們對脊骨盆領域的機會感到相當興奮。如我提到的,我們去年與超過2,400位醫師合作,其中多數是脊椎外科醫師;他們在做SI關節融合手術,而且越來越常進行Granite相關手術。因此,關於這可能成為我們最大市場的說法,是把Granite持續成長的機會納入考量,尤其是在今年10月生效的新DRG支持之下。我們認為這將帶來顯著影響,讓我們與醫院溝通時能把成本因素從討論中移開,並真正協助支持Granite成為脊骨盆固定(spinopelvic fixation)的照護標準。這是第一點。
Number two is also that breakthrough device as well. I did mention that that's targeted towards spine surgeons as well. It does fall into the spinopelvic market category as well, and it is a procedure that they're doing already. It is a product that they may use in the same cases as they're using Granite. So it provides an opportunity to engage new physicians, but also to significantly increase density with our existing physicians, whether it's using that product on its own or whether it's in combination with Granite, where it's going to increase the ASP for that particular case.
第二點也包括那個突破性裝置。我確實提到過,它同樣是針對脊椎外科醫師。它也屬於脊骨盆市場的範疇,而且這是一項他們已經在做的手術。這也是一個他們可能會在同樣病例中、與使用Granite相同情境下使用的產品。因此,它提供了接觸新醫師的機會,也能顯著提高我們既有醫師的使用密度:不論是單獨使用該產品,或與Granite搭配使用,都將提高該病例的ASP(平均銷售單價)。
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Yeah. The other thing I would say, Drew, is we have a pretty active R&D pipeline right now. Laura's talked about it in the past, where we want to get into a regular cadence of launching products. The strategy has been on ensuring that we're going after large unmet markets, but that are also synergistic, both at a procedure level and a call point level. That's what gives us confidence, not just these two products, but the other products that are in the hopper, which we're not going to talk about right now, but we will start talking about as we get closer to FDA clearance or submissions or things like that, consistent with what we've done in the past.
是的。Drew,我還想補充的是,我們目前的研發(R&D)管線相當活躍。Laura過去也談過,我們希望建立規律的產品上市節奏。我們的策略是確保我們鎖定的是尚未被滿足、規模龐大的市場,同時在手術層級與拜訪對象(call point)層級也具有協同效益。這也是我們有信心的原因:不僅是這兩項產品,還包括其他正在籌備中的產品;我們現在不會談,但會在更接近FDA核准(clearance)、送件(submissions)或類似里程碑時開始對外說明,並延續我們過去一貫的做法。
Drew Ranieri - Analyst
Drew Ranieri - Analyst
Got it. I definitely don't want to give the revenue contribution for granted today.
了解。我當然不想把今天的營收貢獻視為理所當然。
All right. Well, next question actually, Anshul, for you. Just you were talking a bit about capital spending in the second and third quarter. It looked like first quarter was the lowest CapEx that you've had over the past several quarters. Just how do we balance that with your commentary about putting more surgical capacity in the field for Smith+Nephew, and more product launches coming throughout the year and into next year? Thanks.
好。那下一個問題其實是給你的,Anshul。你剛才談到第二季與第三季的資本支出。看起來第一季是你們過去幾季以來最低的CapEx。那麼,這要如何與你提到的:為Smith+Nephew在外勤端增加更多手術產能,以及今年到明年將陸續推出更多產品上市的說法相互平衡?謝謝。
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
That's a good question. In terms of CapEx in the business, Drew, I would think the run rate CapEx, just from an instrument tray surgical capacity standpoint, that $9 million-$10 million. We've been in that $8 million-$10 million range given the year when you launch a product, so we believe that that's going to be the right range. There's two offsets to that.
這是個好問題。Drew,就業務的CapEx而言,我認為以器械托盤(instrument tray)的手術產能角度來看,常態化的CapEx大約是900萬到1,000萬美元。在有產品上市的年度,我們一直落在800萬到1,000萬美元的區間,因此我們相信這會是合適的範圍。其中有兩個抵銷因素。
One is new products. We're putting out more capacity for Smith+Nephew. You're going to put out more surgical capacity for the new product that we want to commercialize. But the offset to that also is we're making sure we're driving utilization higher of existing surgical capacity, so you're going to see leverage there. That's number one.
第一是新產品。我們會為Smith+Nephew投放更多產能。我們也會為我們想要商業化的新產品投放更多手術產能。但相對地,我們也會確保提高既有手術產能的使用率,因此你會看到那裡的槓桿效益。這是第一點。
Number two is now that we have a broad expertise in terms of launching multiple products, we're taking a lot of those learnings and making sure we drive the cost of these instrument trays lower as we launch new products. So even though we'll put out more products, those two things will be allowing us to offset some of the capital footprint that we need to grow. So that's one. Now, we do have our new headquarters being built. It's an eight-year lease, so we're in the midst of doing the construction there. So you'll have a bit of one-time spend between Q2 and Q3. But even with that, even with the investment we want to make in the business, we feel very good about our target to get to free cash flow breakeven.
第二點是,現在我們在多產品上市方面已累積廣泛的專業能力,我們會把許多經驗教訓導入,確保在推出新產品時把這些器械托盤的成本降得更低。因此,即使我們會投放更多產品,這兩件事也將讓我們得以抵銷部分成長所需的資本規模。這是一點。另外,我們的新總部正在興建中。這是一份八年期租約,因此我們正處於施工階段。所以在第二季到第三季之間會有一些一次性支出。但即便如此,即便我們希望在業務上進行投資,我們對達成自由現金流損益兩平(free cash flow breakeven)的目標仍然非常有信心。
Operator
Operator
Travis Steed, Bank of America Securities.
Travis Steed,美國銀行證券。
Travis Steed - Analyst
Travis Steed - Analyst
Start out with maybe ask a little bit more about the Smith+Nephew partnership, how that's ramping. You've given a lot of qualitative color, any way to think about the quantitative contribution to growth in 2026 and assumptions in that guide raise?
先從 Smith+Nephew 的合作夥伴關係談起,想再多問一點目前的推進情況。你們已提供很多定性的說明;是否有方式可以思考 2026 年對成長的量化貢獻,以及在該指引上調中所採用的假設?
Laura Francis - Chief Executive Officer, Director
Laura Francis - Chief Executive Officer, Director
We're really excited about the partnership with Smith+Nephew. It covers level 1 and level 2 trauma centers, and it's going to allow our trauma surgeons to gain access to our TNT product as well as TORQ to treat sacral insufficiency fractures. We actually had the Smith+Nephew trauma leadership team here last week in our offices, talking about moving forward our collaboration. The excitement is clear, the commitment is clear, and that's in the field as well as with physicians as well.
我們對與 Smith+Nephew 的合作夥伴關係感到非常興奮。它涵蓋第一級與第二級創傷中心,並將讓我們的創傷外科醫師能夠使用我們的 TNT 產品以及 TORQ 來治療薦骨不全性骨折。其實 Smith+Nephew 的創傷領導團隊上週才到我們辦公室,討論如何推進我們的合作。興奮之情很明顯、承諾也很明確,這不僅在第一線,也同樣體現在醫師端。
We think that our TNT solution is very synergistic with their portfolio, and we're still working through rep training and the rollout should be complete by the end of the second quarter. Given a normal ramp timeline, it would be a few months between training and first case, but we should start to see the revenue contribution here coming in the second half of the year.
我們認為我們的 TNT 解決方案與他們的產品組合具有很強的協同效應;我們仍在進行業務代表訓練,並且預計在第二季末完成上線推廣。依照一般的爬坡時程,從訓練到第一例手術之間通常會有幾個月的間隔,但我們應該會在下半年開始看到營收貢獻。
In terms of providing more information on the opportunity, if you think about the TAM, it's around 60,000 patients in total. It's around $300 million per year is the opportunity that we're targeting here. We'll give more information as the relationship develops, and we'll bake more into our guidance as we see that momentum.
就提供更多機會相關資訊而言,如果你從 TAM(總可服務市場)來看,總計約 60,000 名病患。我們鎖定的機會約為每年 3 億美元。隨著合作關係的發展我們會提供更多資訊,並且在看到動能後,會把更多內容納入我們的財測指引。
Travis Steed - Analyst
Travis Steed - Analyst
Great. That's helpful. Just a quick follow-up. Maybe what you're seeing in the second quarter already in terms of procedure volumes or trends in the spine market more broadly?
很好。這很有幫助。再快速追問一下。你們在第二季目前已經看到的手術量或更廣泛脊椎市場的趨勢是什麼?
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Yeah. So we're not going to provide specific context on what we're seeing in the quarter. We did talk about in our prepared remarks around acceleration as we progress through the first quarter trend we saw in April. The way we are thinking about our business is not even on a quarterly basis, but an annual, multi-annual, multi-year basis. Because a lot of the tailwinds that we've talked about on this call are indeed secular. They're going to be over a few years. You're going to continue to see the impact of that. That confidence is reflected in our guidance.
好的。我們不會就本季所看到的情況提供具體細節。我們在事先準備的講稿中確實提到,隨著第一季推進,我們在 4 月看到的趨勢呈現加速。我們看待業務的方式不是以季度為單位,而是以年度、跨年度、長期多年的角度。因為我們在這通電話中談到的許多順風因素確實是結構性的。它們會持續好幾年。你們會持續看到其影響。這份信心也反映在我們的指引中。
Operator
Operator
Caitlin Roberts, Canaccord Genuity.
Caitlin Roberts,Canaccord Genuity。
Caitlin Roberts - Analyst
Caitlin Roberts - Analyst
Just to start with Europe and OUS, it seems like TNT that you noted was launched earlier than expected in Europe, and then along with the Australian launch of TORQ, do you see these changes as changing the potential OUS growth expectations for this year?
先從歐洲與 OUS(美國以外)談起:看起來你們提到的 TNT 在歐洲的上市時間早於預期;再加上 TORQ 在澳洲的上市,你們是否認為這些變化會改變今年 OUS 的成長預期?
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Yeah, happy to take that, Caitlin. On the international side, yeah, really pleased with how the business did, both in Q4, which was the first full quarter of TORQ being available in Europe, but also what we're seeing in Q1, with TORQ and then the early commercialization of TORQ in Australia and also TNT in broader Europe. It is still 5% or 6% of our business, but it's tracking really well. Given that we're in the early stages of launch we want to be very thoughtful about how those two markets scale for us before we start incorporating upside there.
好的,Caitlin,我很樂意回答。在國際市場方面,是的,我們對業務表現非常滿意:不僅是第四季(那是 TORQ 在歐洲可供使用的第一個完整季度),也包括我們在第一季看到的情況——TORQ、TORQ 在澳洲的早期商業化,以及 TNT 在更廣泛歐洲市場的推進。國際業務目前仍僅占我們業務的 5% 或 6%,但進展非常順利。鑑於仍處於上市初期,我們希望在把潛在上行納入之前,先非常審慎地評估這兩個市場對我們的擴張規模。
We are very confident that Europe, with these two new products, continued with the strength of our SI joint business with the Triangle product, which is what they've had for the longest time, should actually be accretive to worldwide growth, which it hasn't been for the last few years. We like the trajectory of the business, and we like what potential upside could come from it. We're also looking at other international markets where we're seeing physician interest to be able to deploy TNT, TORQ, and potentially even Granite.
我們非常有信心,歐洲在這兩項新產品的帶動下,再加上我們 SI 關節業務(Triangle 產品)持續強勁——這也是他們最早、使用最久的產品——實際上應該會對全球成長帶來增益,而過去幾年並非如此。我們喜歡業務的發展軌跡,也看好其可能帶來的上行空間。我們也在觀察其他國際市場,看到醫師對於導入 TNT、TORQ,甚至可能是 Granite 的興趣。
Caitlin Roberts - Analyst
Caitlin Roberts - Analyst
That's great. Just on the S&N partnership Smith+Nephew is continuing to go through its own efforts in the US, particularly as it works to launch its next-gen knee later this year. I mean, any risk for the ramp for you guys to be slower given the focus for Smith+Nephew, or are these areas mainly separate?
很好。再談 Smith+Nephew(S&N)合作:Smith+Nephew 也正在美國推進自身的工作,尤其是今年稍晚將推出下一代膝關節產品。我的意思是,考量 Smith+Nephew 的重點投入,你們這邊的爬坡是否有變慢的風險?還是這些領域基本上是分開的?
Laura Francis - Chief Executive Officer, Director
Laura Francis - Chief Executive Officer, Director
No, for the most part, these are actually separate areas. We're working specifically with the trauma team there at Smith+Nephew. As I said, the products are very synergistic with one another. They are focusing on the pelvis later this year, and this product is supportive of that.
不會,大多數情況下其實是分開的領域。我們是與 Smith+Nephew 的創傷團隊進行特定合作。如我所說,這些產品彼此之間具有很強的協同效應。他們今年稍晚會聚焦骨盆領域,而這項產品也能支援那個方向。
The fact that it's a breakthrough device, the fact that it has an NTAP of over $4,000, the typical ASP is significantly higher than what Smith+Nephew is used to seeing in their own portfolio. All of these things, I think bode very well for the product and for the uptake with the folks at Smith+Nephew. As I said, we are working with them from a training perspective right now.
它是突破性器材(breakthrough device),而且 NTAP 超過 4,000 美元;其典型 ASP(平均售價)也顯著高於 Smith+Nephew 在其自有產品組合中習慣看到的水準。我認為這些因素都非常有利於產品本身,以及 Smith+Nephew 團隊的採用速度。如我所說,我們目前正與他們進行訓練方面的合作。
We're deploying assets into the field with them. And also it's getting some of these trauma hospitals on the approved list too. So there's a number of things that are more administrative in nature that are going on right now, but we feel that Smith+Nephew is going to be a great partner for us, and we're seeing that commitment from them.
我們也正與他們一起把資源部署到第一線。同時也在把一些創傷醫院納入核准名單。因此目前有不少偏行政性的事項正在進行,但我們認為 Smith+Nephew 會是我們很棒的合作夥伴,而且我們也看到他們的承諾。
Operator
Operator
David Saxon, Needham & Company.
David Saxon,Needham & Company。
David Saxon - Equity Analyst
David Saxon - Equity Analyst
Great. good afternoon, Laura, Anshul. Thanks for taking my questions, and congrats on the quarter. I wanted to ask on just the path to 100 territories over the next year. Just looking back, I mean, that would represent the fastest pace of hiring, you've seen since, I believe, 2021. I guess, like, what's the confidence in getting there, and how important is it to the organization in the context of this upcoming BDD launch?
很好。下午好,Laura、Anshul。謝謝回答我的問題,也恭喜本季表現。我想問一下未來一年拓展到 100 個銷售區域的路徑。回頭看,這將代表你們自我記得是 2021 年以來最快的招募速度。我想問的是,你們對達成這個目標的信心來源是什麼?以及在即將到來的 BDD 上市背景下,這對組織有多重要?
Laura Francis - Chief Executive Officer, Director
Laura Francis - Chief Executive Officer, Director
Yeah, I think actually the last part of your question was the most important part. Since 2021, a lot of our focus in terms of expanding the sales force has been utilizing our hybrid model. We grew from a very small number of third-party agents in 2021 and up until today, where we're over 300 at this point. That has been a very significant way that we've grown the business and gained significant operating leverage on the business. The Smith+Nephew relationship is another part of that particular strategy. Why do we think it's important to grow to those nearly 100 territories over the next 12 months?
是的,我認為你問題的最後一部分其實最重要。自 2021 年以來,我們在擴大銷售團隊方面的重點,很大一部分是運用我們的混合模式。我們從 2021 年非常少量的第三方代理,成長到今天已超過 300 位。這一直是我們擴大業務、並在營運上取得顯著槓桿的一個非常重要方式。Smith+Nephew 的合作關係也是該策略的另一個部分。為什麼我們認為在未來 12 個月內成長到接近 100 個銷售區域很重要?
It does get at this next product that we're going to be launching, a breakthrough device, that we think that has very significant potential to gather yet more surgeons as customers beyond the record that we had this last quarter of 1,650, over 17% growth. Typically, we even see a little bit of a fallback between Q4 and Q1 in terms of the number of surgeons that are using the product, but that was not the case for us in Q1. It is important for us to ramp to get to those 100 territories to be prepared for the launch of this next product from the perspective of adding surgeons. Also, I mentioned the surgeon density, that we think is incredibly important.
這確實切中我們接下來要推出的下一項產品——一款突破性的裝置——我們認為它具有非常顯著的潛力,能在上季創下1,650名外科醫師、年增逾17%的紀錄之外,吸引更多外科醫師成為客戶。通常在使用該產品的外科醫師人數方面,我們甚至會看到Q4到Q1之間略有回落,但我們在Q1並沒有出現這種情況。對我們而言,為了從增加外科醫師的角度為下一項產品的上市做好準備,把版圖擴張、提升到那100個銷售區域是很重要的。另外,我也提到外科醫師密度,我們認為這點極其重要。
We have a tremendous asset in our customer base, and this product will give us the ability to meet the needs of those physicians, whether it's in SI joint fusion, pelvic fixation, or the new indication that we're working on with the next product.
我們的客戶基礎是一項極為重要的資產,而這項產品將使我們有能力滿足這些醫師的需求,無論是在SI關節融合、骨盆固定,或是我們正與下一項產品一同推進的新適應症。
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
And then David, you brought up a really good point on going back to 2021. If you look at what our strategy has been, and you look at what the performance was since in 2021 once we built out the sales force, it was very quickly followed by four new product launches. You launched TORQ, you launched Granite, you launched TNT, and then you launched the Intra family. And what you saw between 2021 and 2025 is growth really inflect in the 22% range on a cumulative -- on a CAGR basis, right? So what you're seeing is a similar playbook now, except we're at a much larger scale.
然後David,你提出了一個很好的觀點,回到2021年來看。如果你看我們的策略,以及自2021年我們擴建銷售團隊之後的表現,很快就接續推出了四項新產品。你們推出了TORQ、推出了Granite、推出了TNT,然後又推出了Intra系列。而你在2021到2025年間看到的是,成長在累計——以CAGR口徑——大約在22%的區間出現明顯加速(拐點),對吧?所以你現在看到的是類似的作戰手冊,只是我們的規模已經大得多。
We still expect to launch new products. We still expect to get a lot more operating scale on the business or operating leverage on the business. But this is an anticipation of what we know is going to be a pretty aggressive innovation cycle for us over the next five years.
我們仍然預期會推出新產品。我們仍然預期業務會獲得更大的營運規模效益或營運槓桿。但這是基於我們知道未來五年我們將進入一個相當積極的創新週期的預期。
David Saxon - Equity Analyst
David Saxon - Equity Analyst
Okay. That was super helpful. Maybe for my second question, Anshul, just on gross margins, obviously really strong performance here in the first quarter. Like, what's driving that? Is that just kind of better leverage on higher revenue or anything from an operational perspective? And then, Anshul, can you just remind us what the latest assumption is in terms of pricing on guidance?
好的。這非常有幫助。也許我的第二個問題,Anshul,關於毛利率,顯然第一季表現非常強勁。是什麼在驅動這個表現?這只是因為營收更高帶來更好的槓桿效應,還是有任何營運面的因素?另外,Anshul,你能否提醒我們,在指引中對定價的最新假設是什麼?
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Sure. On the gross margin side, David, again, really pleased with the nearly 80% margins. It's 79.8%, nearly 80% margin, which look, we're really proud of. They are industrial leading, they're ahead of our expectations. That's why we reflected that in our increased guidance by increasing gross margins by 100 basis points for the year. A lot of that is driven by the better-than-expected execution, both on the procedure mix side, the ASP came in a bit better. Also, we are seeing the incremental impact of the supply chain efficiencies and cost optimization initiatives that we've put in place. So we feel really good about the trend there.
當然。在毛利率方面,David,我們同樣對接近80%的毛利率感到非常滿意。是79.8%,接近80%的毛利率,坦白說,我們非常自豪。這是業界領先的水準,也高於我們的預期。因此我們在上調指引時也反映了這點,把全年毛利率上調了100個基點。其中很大一部分來自於執行優於預期,包含手術組合(procedure mix)方面,ASP也略優於預期。此外,我們也看到我們已推動的供應鏈效率與成本優化措施帶來的增量影響。所以我們對這個趨勢感覺非常好。
Now, as we launch new products, including the rollout of additional surgical capacity to support Smith+Nephew, we do expect some non-cash impact, i.e., depreciation of those instrument trays, in the back half of the year, and that's incorporated in our updated guidance sell of 79% for the year.
另外,隨著我們推出新產品,包括擴增額外的手術產能以支援Smith+Nephew,我們預期在下半年會有一些非現金影響,也就是那些器械托盤的折舊,而這已納入我們更新後的全年指引,全年約79%。
In terms of ASP, we're still maintaining a conservative position on ASP. We started the year at mid-single-digit ASP decline. Now we've done better than that. Granite's been a big contributor to that because of more four-implant cases than we had in our initial guidance. We're still assuming low single-digit ASP degradation. Now, we think we can do better than that, but the reason for that assumption is for our interventional with the Intra family, you generally have fewer implants used.
在ASP方面,我們仍維持對ASP的保守立場。我們在年初的假設是ASP中個位數(mid-single-digit)的下滑。目前我們的表現優於該假設。Granite是主要貢獻者,因為四植入物(four-implant)病例比我們最初指引中假設的更多。我們仍假設ASP低個位數(low single-digit)下滑。我們認為可以做得更好,但之所以這樣假設,是因為在我們的介入性(interventional)業務、也就是Intra系列中,一般使用的植入物數量較少。
Within trauma, again, you might have anywhere between one and two implants used in a procedure. We're embedding that as potential pressure on ASP. What we're still not incorporating is the upside of Granite continuing to see more four-implant cases and the continued strength in the SI joint business where you use three implants.
在創傷(trauma)領域,同樣地,一台手術可能只會使用一到兩個植入物。我們把這點納入為對ASP的潛在壓力。我們仍未把Granite持續出現更多四植入物病例,以及SI關節業務持續強勁(通常使用三個植入物)所帶來的上行空間納入。
Operator
Operator
David Turkaly, Citizens.
David Turkaly,Citizens。
David Turkaly - Analyst
David Turkaly - Analyst
Hey, good evening. Just quickly, Anshul, I know you mentioned the headquarters. Did you put a dollar amount on that? Then, I just wanted to check from a capital allocation standpoint, you have a lot of cash, your priorities there and has a buyback ever been considered?
嗨,晚安。Anshul,我想快速問一下,我知道你提到了新總部。你有提到那部分的金額嗎?另外我想從資本配置的角度確認一下,你們有很多現金,你們在這方面的優先順序是什麼?以及是否曾考慮過庫藏股回購?
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
From a CapEx perspective, like I said, on just traditional surgical capacity, it's around $9 million to $10 million for the year, and then you've got another $4 million-plus on CapEx for the new headquarters. Now some of that will get reimbursed as part of the TI allowance. It's just the timing is TBD based on the way the contract's structured. That's where the CapEx sits.
從資本支出(CapEx)的角度,如我所說,僅就傳統的手術產能而言,全年大約是900萬到1,000萬美元,另外新總部還有400萬美元以上的資本支出。其中一部分會作為TI allowance的一部分獲得補償。只是時間點仍待定(TBD),取決於合約結構的安排方式。這就是CapEx的水位。
And your next question was around buybacks. Yeah, look, when we think about capital allocation our focus remains on making investments in R&D, in new product innovation, on clinical data, especially as we look at the number of products that we have in the hopper that we want to commercialize. Supporting that will be surgical capacity. And the last piece is building the commercial infrastructure to continue to support that growth. Now we do like the way the business is positioned with the growth in gross margin dollars, the continued inflection on operating leverage, but our focus remains on growth and investing in growth-accretive opportunities within the business.
你下一個問題是關於回購。是的,當我們思考資本配置時,我們的重點仍然是投資於研發(R&D)、新產品創新、臨床數據,特別是考量到我們有多項正在管線中、希望商業化的產品。支援這些的會是手術產能。最後一塊是建立商業化基礎設施,以持續支援成長。我們確實喜歡目前業務的定位:毛利美元額成長、營運槓桿持續出現拐點;但我們的重點仍是成長,以及投資於公司內部能增厚成長的機會。
Operator
Operator
Richard Newitter, Truist Securities.
Richard Newitter,Truist Securities。
Richard Newitter - Analyst
Richard Newitter - Analyst
Maybe just on the cadence of the revenue guide, I know you said you expect acceleration moving through the year. It looks like consensus is right around 15%-16% growth, so 2Q or about $55 million. I guess, that would imply maybe something like 2.5% year-over-year acceleration in year-over-year increases moving through the year. Is that about right? Can you comment on that cadence and the 2Q number at all?
也許就營收指引的節奏來問一下,我知道你說你預期全年會逐季加速。看起來市場一致預期大約是15%到16%的成長,所以2Q大概是5,500萬美元左右。我想,這可能意味著在全年推進過程中,同比增速大概會逐步加快約2.5個百分點左右。大概是這樣嗎?你能否評論一下這個節奏,以及2Q的數字?
Just on that topic as well, you maintained your operating expense growth guidance. I guess, you're coming out of the gates here at almost 3 times your top line growth versus your OpEx growth. I'm just curious to know is there what's behind that? Where are the expenses getting pushed out if that's the case, or is that just conservatism right now?
同樣在這個主題上,你們維持了營業費用(operating expense)的成長指引。我想,你們現在一開始的狀態是,營收成長幾乎是OpEx成長的3倍。我只是好奇這背後的原因是什麼?如果真是如此,費用是被往後遞延到哪裡了,還是說目前只是比較保守?
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Anshul Maheshwari - Chief Financial Officer, Chief Operating Officer
Yeah. Happy to take both those questions, Richard. In terms of trending by quarters, as you know, we don't provide quarterly guidance, and we like to manage the business on a full-year, multi-year basis. And we do expect year-over-year growth to accelerate. Now our current assumption is the acceleration is going to be more pronounced in the second half of the year. Part of that is just timing of scaling of this new product with an interventional. But also, as Laura talked about, the Smith+Nephew partnership, the expectation that you really start seeing a meaningful contribution in the third and the fourth quarter. So you might see some timing shift between Q2 and Q3, mostly because of the Smith+Nephew partnership.
是的。Richard,很樂意回答這兩個問題。就按季度的趨勢而言,如你所知,我們不提供季度指引,我們也傾向以全年、跨年度的方式來管理業務。我們確實預期年對年成長將會加速。目前我們的假設是,加速會在下半年更為明顯。其中一部分只是與這項新產品搭配介入式(interventional)推進擴量的時點有關。但同時,如Laura提到的,Smith+Nephew 的合作夥伴關係,預期你會在第三與第四季開始看到有意義的貢獻。因此你可能會看到Q2與Q3之間有一些時點上的移轉,主要是因為Smith+Nephew的合作。
But for the year, we feel really good about where the growth is going, and more importantly, the exit ramp from fourth quarter going into 2027. That's there. On the spend side, you're right. We like the operating leverage we saw in the business. From an expense standpoint, when you are at our scale, timing can have a big impact. We are in the second and third quarter, right in the midst of our V&V testing and a lot of our work on FDA regulatory submissions, as well as marketing activities, both for Intra Ti, which was launched, but also for this new product we want to commercialize in the fourth quarter. So you're going to see a bulk of that spend there.
但就全年而言,我們對成長走向感到非常有信心,更重要的是,從第四季結束一路延伸到進入2027年的退出斜率(exit ramp)。那是存在的。在支出方面,你說得對。我們喜歡在業務中看到的營運槓桿。從費用角度來看,當你處於我們這樣的規模時,時點可能會產生很大的影響。我們在第二與第三季,正處於V&V測試以及大量FDA法規申報工作的進行中,同時也有行銷活動,既包括已推出的Intra Ti,也包括我們希望在第四季商業化的這項新產品。因此你會看到大部分支出集中在那裡。
We're also embedding R&D spend that is going to have an impact on products we want to launch in 2027. So you're seeing an OpEx expense growth rate embedding a lot of the spend that could contribute to revenue upside as we progress to the back half of the year. So that might mean there's some upside on the operating leverage too. We believe it's better to be conservative, incorporate the spend, and then let the growth speak for itself as we progress through the year.
我們也在納入將影響我們希望於2027年推出之產品的研發支出。因此你看到的營運費用(OpEx)成長率,包含了大量支出;隨著我們進入下半年,這些支出可能會帶來營收上行的貢獻。所以這也可能意味著營運槓桿方面也有一些上行空間。我們認為更好的做法是保守一些,把支出納入,然後在一年推進過程中讓成長自行證明。
Richard Newitter - Analyst
Richard Newitter - Analyst
That's really helpful. And then maybe just on this DRG proposal or the upcode tailwind. This seems like a really big potential tailwind for you. I guess, one, is this something that you were expecting, that you'd been lobbying for or not lobbying, but the kind of you were expecting this outcome? Why wouldn't this just be a really enormous tailwind for you next year?
這非常有幫助。接著也許談談這個DRG提案或上調編碼(upcode)的順風。這看起來對你們而言是一個非常大的潛在順風。我想,第一,這是你們原本就預期會發生的嗎?你們是否一直在遊說,或不是遊說,但你們是否預期會有這樣的結果?為什麼這不會在明年成為你們一個非常巨大的順風?
Laura Francis - Chief Executive Officer, Director
Laura Francis - Chief Executive Officer, Director
Richard, it's a great question, we quite frankly do think this is a very significant and underappreciated tailwind. Granted, first of all, it has been one of our fastest scaling products in the history of the company. We addressed this unmet clinical need in terms of fixation failure and multi-level constructs. We have a fair amount of clinical data that actually shows the benefit of the technology, and it really should become the standard of care in 130,000 cases per year in the US, I think number one is just the product itself is an incredibly important product to these patients and surgeons who are working with patients that need multi-level constructs.
Richard,這是個很好的問題;坦白說,我們確實認為這是一個非常顯著且被低估的順風。首先,這一直是公司歷史上擴量最快的產品之一。我們在固定失敗(fixation failure)與多節段構建(multi-level constructs)方面滿足了未被滿足的臨床需求。我們有相當多的臨床數據實際顯示這項技術的效益,而且我認為它確實應該成為美國每年13萬例手術的照護標準;第一點就是,產品本身對這些病患以及為需要多節段構建病患進行治療的外科醫師而言,是一個極其重要的產品。
When you get into the rule itself, the inpatient rule created a new DRG group for complex and extensive spine surgeries, and under the proposal, granite is one of only two technologies for which those procedures automatically map to the new DRGs. The proposal is actually significantly better than what we had requested from CMS. We've been in discussions with CMS for not one year, but two years. Our initial request was a reassignment of granite cases to higher severity levels within the existing DRGs. When CMS actually looked at the data, they concluded that the reassignment actually wouldn't fully address the cost differential, instead of moving cases around within the existing structure, they created the new DRG family.
談到這項規則本身,住院規則為複雜且廣泛的脊椎手術建立了一個新的DRG群組;在該提案下,Granite是僅有的兩項技術之一,這些手術會自動對應到新的DRG。這項提案實際上顯著優於我們向CMS所提出的請求。我們與CMS的討論不是一年,而是兩年。我們最初的請求,是將Granite病例在既有DRG內重新分派到更高嚴重度等級。當CMS實際檢視數據後,他們的結論是,這樣的重新分派並不能充分反映成本差異;因此他們不是在既有架構內移動病例,而是建立了新的DRG家族。
The improvement in the hospital payment under the proposed new DRGs could be as high as $50,000. I mentioned that in my pre-prepared remarks. Although it depends on the specifics of the patient diagnosis and severity. What's interesting about this too is that these new DRGs are more durable than an NTAP. They're not a temporary fix. The NTAP also was only limited to Medicare patients, and if finalized, we expect commercial payers to broadly adopt the new DRGs alongside CMS.
在所提議的新DRG下,醫院給付的改善幅度最高可能達到50,000美元。我在事先準備的發言中提到過。當然這取決於病患診斷與嚴重度的具體情況。另外有趣的是,這些新的DRG比NTAP更具持久性。它們不是暫時性的修補。NTAP也僅限於Medicare病患;若最終定案,我們預期商業保險支付方將會在CMS之外廣泛採用新的DRG。
In summary, we do strongly believe the new DRGs are going to have a positive impact on the spinal pelvic market opportunity that we're going after with Granite, assuming that they're finalized as proposed. We think the incremental reimbursement is going to support the adoption of our Granite technology, and it's going to remove cost as a potential objection. I hope that helps.
總結來說,若新的DRG如提案所述最終定案,我們確實強烈相信它們將對我們以Granite所瞄準的脊椎—骨盆市場機會帶來正面影響。我們認為新增的給付將支持我們Granite技術的採用,並且會消除成本作為潛在反對理由。希望這能有所幫助。
Operator
Operator
Thank you. I'm showing no further questions at this time. I would now like to turn it back to Laura Francis for closing remarks.
謝謝。我目前顯示沒有其他問題。我現在想把時間交回給Laura Francis作結語。
Laura Francis - Chief Executive Officer, Director
Laura Francis - Chief Executive Officer, Director
Yeah, I just wanted to say thank you to everybody for participating in today's call. We really appreciate your interest in SI-BONE, and we look forward to seeing you all at upcoming conferences as well as non-deal roadshows. Goodbye.
是的,我只是想對今天參與電話會議的各位說聲謝謝。我們非常感謝大家對SI-BONE的關注,也期待在即將到來的各項會議以及非交易路演(non-deal roadshows)上與各位見面。再見。
Operator
Operator
This concludes today's conference call. Thank you for participating. You may now disconnect.
今天的電話會議到此結束。感謝各位參與。您現在可以斷線。