AtriCure, Inc. (ATRC) 2026 Q1 法說會逐字稿

Good afternoon, and welcome to AtriCure’s first-quarter 2026 earnings conference call. This call is being recorded for replay purposes, and at this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session following prepared remarks from AtriCure’s management.

下午好，歡迎參加 AtriCure 2026 年第一季財報電話會議。本次電話會議將錄音以供重播，目前所有與會者皆處於僅收聽模式。在 AtriCure 管理團隊完成事先準備的發言後，我們將進行問答環節。

I would now like to turn the call over to Marissa Bych from the Gilmartin Group for a few introductory comments.

現在我想把電話交給 Gilmartin Group 的 Marissa Bych，請她先做幾點開場說明。

Great, thank you. By now, you should have received a copy of the earnings press release. If you have not received a copy, please call 513-644-4484 to have one emailed to you.

好的，謝謝。此時各位應已收到本次財報新聞稿的副本。若您尚未收到，請致電 513-644-4484，我們將以電子郵件寄送給您。

Before we begin today, let me remind you that the company’s remarks include forward-looking statements. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond AtriCure’s control, including risks and uncertainties described from time to time in AtriCure’s SEC filings.

在我們今天開始之前，提醒各位公司發言包含前瞻性陳述。前瞻性陳述受到眾多風險與不確定性影響，其中許多超出 AtriCure 的控制範圍，包括 AtriCure 不時在向美國證券交易委員會（SEC）提交的文件中所描述的風險與不確定性。

These statements include, but are not limited to, financial expectations and guidance, expectations regarding the potential market opportunity for AtriCure's franchises and growth initiatives, future product approvals and clearances, competition, reimbursement, and clinical trial enrollment and outcome. AtriCure’s results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statement.

這些陳述包括但不限於：財務預期與指引、對 AtriCure 各產品線與成長計畫之潛在市場機會的預期、未來產品核准與許可、競爭、給付/報銷，以及臨床試驗收案與結果。AtriCure 的實際結果可能與預測有重大差異。AtriCure 不承擔公開更新任何前瞻性陳述之義務。

Additionally, we will refer to non-GAAP financial measures, specifically constant currency revenue, adjusted EBITDA, and adjusted loss per share. A reconciliation of these non-GAAP financial measures with the most directly comparable GAAP measures is included in our press release, which is available on our website.

此外，我們將提及非 GAAP 財務衡量指標，具體包括：固定匯率營收（constant currency revenue）、調整後 EBITDA，以及調整後每股虧損。這些非 GAAP 財務衡量指標與最直接可比的 GAAP 指標之調節表已包含於我們的新聞稿中，並可於公司網站取得。

And with that, I would like to turn the call over to Mike Carrel, President and Chief Executive Officer.

接下來，我想把電話交給總裁兼執行長 Mike Carrel。

pGreat. Good afternoon, everyone, and welcome to our call. AtriCure is off to a strong start in 2026, with worldwide revenue of $140 million in the first quarter, reflecting 14% growth year over year. We are building on momentum we established in 2025 from new product launches, with this quarter marking an acceleration in our worldwide growth rate from the preceding quarter and comparable quarter last year. Fueling this acceleration is our US business which drove approximately 15% growth in the quarter from expanding adoption of AtriClip FLEX-Mini and PRO-Mini devices, cryoSPHERE MAX Probe, and continued strength from our EnCompass clamp.

p太好了。各位下午好，歡迎參加本次電話會議。AtriCure 在 2026 年開局強勁，第一季全球營收達 1.40 億美元，年增 14%。我們延續 2025 年新產品上市所建立的動能；本季全球成長率較前一季以及去年同期皆呈現加速。推動此加速成長的是我們的美國業務：受惠於 AtriClip FLEX-Mini 與 PRO-Mini 裝置、cryoSPHERE MAX 探針的採用擴大，以及 EnCompass 夾鉗持續強勁的表現，本季約帶動 15% 的成長。

In addition, we generated $17 million in adjusted EBITDA, nearly double the first quarter of last year. Our results this quarter once again demonstrate our ability to deliver durable double-digit revenue growth and expand profitability. Beyond our financial results, we have made exceptional progress in our Box-NoAF clinical trial. Since initiating trial enrollment in the fourth quarter of last year, we have enrolled approximately 300 total patients to date in this 960-patient randomized controlled trial.

此外，我們創造了 1,700 萬美元的調整後 EBITDA，幾乎是去年第一季的兩倍。本季業績再次展現我們具備實現穩健的兩位數營收成長並提升獲利能力的實力。除財務表現外，我們在 Box-NoAF 臨床試驗方面也取得卓越進展。自去年第四季啟動收案以來，截至目前我們已在這項 960 名患者的隨機對照試驗中累計收案約 300 名患者。

We are tracking well ahead of our original timeline and now expect complete enrollment around the end of this year, nearly one year ahead of plan. The pace of enrollment in this trial reflects an extremely high level of engagement from surgeons who experience firsthand the impact postoperative AFib has on their patients. As a reminder, up to 50% of cardiac surgery patients without preexisting AFib will develop postoperative AFib, which is the most common complication of cardiac surgery. Because there is no established treatment today, postoperative AFib is a substantial burden on healthcare spending, with estimates exceeding $2 billion annually in the US alone.

我們的進度明顯超前原先時程，現預期可在今年年底左右完成收案，較原計畫提前近一年。本試驗的收案速度反映外科醫師高度投入，因為他們親眼見證術後心房顫動（AFib）對患者造成的影響。提醒各位，最高可達 50% 原本沒有既存 AFib 的心臟手術患者會出現術後 AFib，而這是心臟手術最常見的併發症。由於目前尚無既定治療方式，術後 AFib 對醫療支出造成沉重負擔，僅在美國的年度支出估計就超過 20 億美元。

We are confident that our Box-NoAF clinical trial, utilizing our EnCompass clamp and AtriClip device, has the potential to meaningfully change treatment outcomes for this patient population and address the significant unmet clinical need. Box-NoAF is also highly complementary to our LeAAPS clinical trial, studying stroke reduction benefit of left atrial appendage management in cardiac surgery patients without atrial fibrillation. We expect both of our landmark clinical trials to generate robust clinical evidence in support of preventative treatments for cardiac surgery patients, unlocking a massive global market opportunity for AtriCure while establishing new standards of care in cardiac surgery. We at AtriCure are well positioned to realize these significant catalysts for our business in the coming years.

我們有信心，Box-NoAF 臨床試驗使用我們的 EnCompass 夾鉗與 AtriClip 裝置，具備顯著改善此患者族群治療結果的潛力，並可回應重大的未被滿足臨床需求。Box-NoAF 也與我們的 LeAAPS 臨床試驗高度互補；LeAAPS 研究在無心房顫動的心臟手術患者中，左心耳處置對降低中風的效益。我們預期這兩項里程碑式臨床試驗將產出強而有力的臨床證據，以支持對心臟手術患者的預防性治療，為 AtriCure 開啟龐大的全球市場機會，同時建立心臟手術的新照護標準。AtriCure 已做好充分準備，在未來幾年把握這些對公司業務具有重大推動力的催化因素。

Now on to updates covering franchise performance in the first quarter. Pain Management once again led our portfolio growth, increasing 28% year over year. The cryoSPHERE MAX Probe continues to be the primary driver of growth, contributing roughly 70% of our Pain Management sales this quarter. Surgeons across both new and existing accounts recognize the significant time savings and clinical effectiveness it provides, leading to more patients having their postoperative pain managed effectively.

接下來更新第一季各產品線的表現。疼痛管理（Pain Management）再次領先我們的產品組合成長，年增 28%。cryoSPHERE MAX 探針仍是主要成長動能，本季約貢獻疼痛管理銷售額的 70%。無論是新客戶或既有客戶的外科醫師，都認可其帶來的顯著節省時間與臨床療效，使更多患者的術後疼痛得以有效管理。

Building on our legacy of innovation, we are also pleased that our cryoXT probe for amputation procedures is beginning to gain traction. We continue to receive outstanding feedback from each new surgeon that uses this device and, through our registries, are capturing clinical outcomes for this therapy. We are still in the early innings for the cryoXT for the cryotherapy development and adoption. However, we remain confident in cryoXT contributing more meaningfully as we move to the back half of 2026.

延續我們的創新傳統，我們也很高興看到用於截肢手術的 cryoXT 探針開始獲得市場動能。我們持續從每位使用該裝置的新外科醫師收到極佳回饋，並透過登錄研究（registries）蒐集此療法的臨床結果。就冷凍治療（cryotherapy）的開發與採用而言，cryoXT 仍處於早期階段。然而，我們仍有信心，隨著進入 2026 年下半年，cryoXT 將做出更具實質性的貢獻。

Within our cardiac ablation franchises worldwide, open ablation revenue grew 15% in the first quarter, led by steady adoption of EnCompass Clamp in the United States and Europe. EnCompass is delivering growth from both new and existing accounts, even as we approach the four-year anniversary of our US full market launch. As mentioned in our fourth-quarter earnings call, our efforts to drive treatment of AFib in cardiac surgery patients was validated with the recent announcement from the Society of Thoracic Surgeons annual meeting, including concomitant AFib treatment as a quality metric. There is strong precedent for the impact of quality metrics in cardiac surgery, and we believe this change will support increased adoption for surgical AFib ablation and appendage management, serving as a durable tailwind for growth for years ahead.

在我們全球的心臟消融（cardiac ablation）產品線中，第一季開胸消融（open ablation）營收成長 15%，主要由 EnCompass 夾鉗在美國與歐洲的穩定採用所帶動。即使我們即將迎來美國全面上市四週年，EnCompass 仍同時在新客戶與既有客戶中帶來成長。如同我們在第四季財報電話會議中提到的，我們推動心臟手術患者 AFib 治療的努力，已在近期胸腔外科醫師學會（Society of Thoracic Surgeons）年會的公告中獲得驗證：將合併（concomitant）AFib 治療納入品質指標。品質指標在心臟手術領域的影響已有強力先例；我們相信此變更將支持外科 AFib 消融與左心耳處置的採用提升，並在未來多年成為持久的成長順風。

Our minimally invasive ablation franchise continued to face headwinds in the first quarter. We believe there’s a role for hybrid therapy in the current and future treatment landscape, and remain committed to providing a solution for the unmet need for patients with longstanding persistent AFib.

我們的微創消融（minimally invasive ablation）產品線在第一季仍持續面臨逆風。我們相信混合療法（hybrid therapy）在目前與未來的治療版圖中仍有其角色，並將持續致力於為長期持續性 AFib 患者的未被滿足需求提供解決方案。

Finally, turning to our appendage management franchise which saw 16% growth worldwide driven by both our open and minimally invasive appendage management products, our open left atrial appendage management business benefited from strong adoption of AtriClip FLEX-Mini in the United States, where we exited the quarter with FLEX-Mini contributing approximately 40% of our open appendage management revenue. More importantly, we believe our FLEX-Mini device has been impactful in driving share gains in this market.

最後，談到我們的左心耳處置（appendage management）產品線：在開胸與微創左心耳處置產品的共同帶動下，全球年增 16%。我們的開胸左心耳處置業務受惠於 AtriClip FLEX-Mini 在美國的強勁採用；本季結束時，FLEX-Mini 約貢獻我們開胸左心耳處置營收的 40%。更重要的是，我們相信 FLEX-Mini 裝置已在推動我們於該市場的市占提升方面發揮了顯著影響。

Surgeons using our or are trialing competitive devices are impressed by the small form factor of AtriClip FLEX-Mini, along with robust clinical evidence and superior product performance of our AtriClip devices. In minimally invasive procedures, AtriClip PRO-Mini is building upon that adoption in the US, providing a pricing uplift that offsets pressure of our hybrid AF therapy procedure volumes. It remains clear that differentiated innovation plays an important role in maintaining our position as the leader in appendage management in cardiac surgery, and we continue to prioritize investments in this platform. In our international markets, we are growing adoption across our legacy left atrial appendage management devices. Following the first quarter, we received CE mark under EU MDR in Europe for both AtriClip FLEX-Mini and PRO-Mini devices, and expect to launch both products in Europe later this year.

使用我們的產品或正在試用競品裝置的外科醫師，對 AtriClip FLEX-Mini 的小巧外形印象深刻，同時也肯定我們 AtriClip 裝置具備扎實的臨床證據與優異的產品表現。在微創手術中，AtriClip PRO-Mini 正在美國延續並擴大此一採用趨勢，帶來的價格提升可抵消我們混合式 AF 治療手術量所承受的壓力。我們仍然清楚，具差異化的創新在維持我們於心臟外科左心耳管理領域的領導地位方面扮演重要角色，因此我們持續優先投入此平台。在國際市場方面，我們的既有左心耳管理裝置正持續提升採用率。第一季結束後，我們在歐洲取得 AtriClip FLEX-Mini 與 PRO-Mini 兩款裝置的 EU MDR CE 認證，並預期於今年稍晚在歐洲推出這兩項產品。

New product launches in Europe, the United States, China, and Japan, coupled with the future of LeAAPS clinical trial outcomes, provide a long runway for growth in our appendage management franchise. In closing, the performance we delivered this quarter underscores the power of our innovation and focus on execution. While the rapid progress in our BoxX-NoAF clinical trial reinforces the significant opportunity ahead at AtriCure. We remain committed to advancing standards of care, scaling responsibly, and delivering durable growth with improving profitability for our shareholders.

在歐洲、美國、中國與日本的新產品上市，加上未來 LeAAPS 臨床試驗結果，為我們的左心耳管理產品線提供了長期的成長跑道。最後，本季的表現凸顯我們創新能力與執行聚焦所帶來的力量。同時，我們 BoxX-NoAF 臨床試驗的快速進展也再次印證 AtriCure 未來可觀的機會。我們仍致力於推動照護標準提升、負責任地擴張規模，並在獲利能力持續改善的同時，為股東帶來可持續的成長。

And with that, I’ll turn the call over to Angie Wirick, our Chief Financial Officer. Angie?

接下來，我把電話會議交給我們的財務長 Angie Wirick。Angie？

Thanks, Mike. Worldwide revenue for the first quarter of 2026 was $141.2 million, up 14.3% on a reported basis and 12.8% on a constant currency basis versus the first quarter of 2025. Our performance reflects substantial growth driven by the continued adoption of key new products in the United States and many regions throughout the world. On a sequential basis, worldwide revenue increased approximately 1% compared to the fourth-quarter 2025. First-quarter 2026 US revenue was $116.2 million, a 14.9% increase from the first quarter of 2025.

謝謝你，Mike。2026 年第一季全球營收為 1.412 億美元，按報告基礎年增 14.3%，按固定匯率基礎年增 12.8%，相較於 2025 年第一季。我們的表現反映出強勁成長，主要由美國及全球多個地區持續採用關鍵新產品所帶動。按季比較，全球營收較 2025 年第四季約增加 1%。2026 年第一季美國營收為 1.162 億美元，較 2025 年第一季成長 14.9%。

Open Ablation product sales grew 17.3% to $39.1 million, fueled by the strong and sustained adoption of our EnCompass Clamp across new and existing accounts. US sales of Appendage Management products were $48.4 million, up 14.9% over the first quarter of 2025, driven primarily by increasing adoption of our AtriClip FLEX-Mini and PRO-Mini devices. US MIS Ablation sales were $6.4 million, a decline of approximately 25% over the first quarter of 2025.

開胸消融（Open Ablation）產品銷售成長 17.3% 至 3,910 萬美元，主要受惠於我們 EnCompass Clamp 在新舊客戶中強勁且持續的採用。美國左心耳管理（Appendage Management）產品銷售為 4,840 萬美元，較 2025 年第一季成長 14.9%，主要由 AtriClip FLEX-Mini 與 PRO-Mini 裝置採用率提升所帶動。美國微創消融（MIS Ablation）銷售為 640 萬美元，較 2025 年第一季約下滑 25%。

And finally, US Pain Management sales were $22.4 million, up 29.5% over the first quarter of 2025, led by the cryoSPHERE MAX probe which contributed approximately 70% of Pain Management sales in the quarter, driving increased adoption in both thoracic and sternotomy procedures. International revenue totaled $25 million for the first quarter of 2026, up 11.5% on a reported basis and up 3.3% on a constant currency basis as compared to the first quarter of 2025. European sales were $16.1 million, up 13.2%, and Asia Pacific and other international market sales were $8.9 million, up 8.4%. International growth was tempered by continued uncertainty in the UK, as well as lower distributor sales in Asia. Offsetting these headwinds, we saw significant growth across franchises in other major geographies largely driven by our direct markets.

最後，美國疼痛管理（Pain Management）銷售為 2,240 萬美元，較 2025 年第一季成長 29.5%，主要由 cryoSPHERE MAX 探針帶動；該探針本季約占疼痛管理銷售的 70%，推動其在胸腔與正中開胸（sternotomy）手術中的採用增加。2026 年第一季國際營收合計 2,500 萬美元，按報告基礎年增 11.5%，按固定匯率基礎年增 3.3%，相較於 2025 年第一季。歐洲銷售為 1,610 萬美元，成長 13.2%；亞太及其他國際市場銷售為 890 萬美元，成長 8.4%。國際成長受到英國持續不確定性以及亞洲經銷商銷售較低的影響而有所抑制。抵消上述逆風的是，我們在其他主要地區的各產品線皆見到顯著成長，主要由我們的直營市場所帶動。

Gross margin for the first quarter of 2026 was 77.4%, up 246 basis points from the first quarter of 2025. The increase was driven primarily by favorable product and geographic mix, with strong US performance propelled by our new product launches and adoption. Transitioning to operating expenses for the quarter, total operating expenses increased $10.2 million, or 10.3%, from $98.6 million in the first quarter of 2025 to $108.8 million in the first quarter of 2026. Rapid enrollment in our Box-NoAF clinical trial, which offsets a decrease in LeAAPS clinical trial costs, along with increased headcount focused on product development initiatives, resulted in a 7.6% increase in Research and Development expense from the first quarter of 2025. SG&A expense increased 11.2% from the first quarter of 2025 as we continue to support growth while driving leverage across the organization.

2026 年第一季毛利率為 77.4%，較 2025 年第一季提高 246 個基點。此一提升主要由有利的產品與地區組合所驅動；美國市場表現強勁，受惠於新產品上市與採用率提升。轉至本季營業費用，總營業費用由 2025 年第一季的 9,860 萬美元增加 1,020 萬美元（或 10.3%）至 2026 年第一季的 1.088 億美元。Box-NoAF 臨床試驗快速收案（抵消 LeAAPS 臨床試驗成本下降），加上聚焦產品開發計畫的人力增加，使研發費用較 2025 年第一季增加 7.6%。銷售、一般及行政（SG&A）費用較 2025 年第一季增加 11.2%，因我們在支持成長的同時，持續推動組織槓桿效益。

Completing the P&L, first-quarter 2026 adjusted EBITDA was $17.1 million compared to $8.8 million for the first quarter of 2025, representing a 95% increase. We recorded net income of approximately $100,000 compared to a net loss of $6.7 million in the first quarter of 2025. Earnings per share and adjusted earnings per share were both break even at $0.00 compared to a loss per share and adjusted loss per share of $0.14 in the first quarter of 2025. Our results reflect a balanced approach to allocating capital toward areas we believe will sustain and accelerate growth, all while continuing to improve profitability.

完成損益表部分，2026 年第一季調整後 EBITDA 為 1,710 萬美元，較 2025 年第一季的 880 萬美元增加 95%。我們錄得淨利約 10 萬美元，相較於 2025 年第一季淨損 670 萬美元。每股盈餘與調整後每股盈餘皆為損益兩平（$0.00），相較於 2025 年第一季每股虧損與調整後每股虧損為 $0.14。我們的結果反映出在資本配置上採取平衡策略，將資本投入我們認為可維持並加速成長的領域，同時持續提升獲利能力。

Now turning to our balance sheet, we ended the first quarter with approximately $146 million in cash and investments. Cash burn for the quarter was slightly improved from the first quarter of 2025 and reflects our normal pattern of cash usage driven by share vesting, variable compensation, and operational needs. As we move through the remainder of the year, we expect positive cash flow results and full year cash generation that is moderately higher than 2025. Our balance sheet remains healthy and supports both current operations and our investment in strategic initiatives that we believe will drive long-term value creation.

接著看資產負債表，我們在第一季末持有約 1.46 億美元的現金與投資。本季現金消耗較 2025 年第一季略有改善，並反映我們因股票歸屬、變動薪酬與營運需求所驅動的正常現金使用模式。隨著今年剩餘期間的推進，我們預期將呈現正向現金流，且全年現金創造將較 2025 年中度提高。我們的資產負債表仍維持健康，足以支撐目前營運以及我們對策略性計畫的投資；我們相信這些投資將驅動長期價值創造。

And now onto our outlook for 2026. We are reiterating our expectations for full-year revenue of $600 million to $610 million, reflecting growth of approximately 12% to 14% over full-year 2025 results. Consistent with our first-quarter results, we expect performance over the remainder of the year to be driven by our Pain Management, Appendage Management, and Open Ablation franchises, and partially offset by continuation of headwinds from our MIS Ablation franchise along with certain international markets.

接下來談 2026 年展望。我們重申全年營收預期為 6.00 億至 6.10 億美元，反映相較 2025 年全年結果約 12% 至 14% 的成長。與第一季結果一致，我們預期今年剩餘期間的表現將由疼痛管理、左心耳管理與開胸消融三大產品線帶動，並部分被微創消融產品線的逆風以及部分國際市場的逆風所抵消。

For the second quarter, we anticipate typical seasonality translating to mid single-digit sequential growth. Our gross margin, while our first quarter 2026 results were exceptional as a result of extremely favorable mix, we continue to expect modest improvement in full-year 2026 gross margin over full year 2025. Product and geographic mix are expected to be favorable in the near term. However, we will bring our expanded manufacturing facilities online in the second half of 2026, which will increase manufacturing cost burden, moderating the full-year gross margin outlook.

就第二季而言，我們預期典型季節性因素將帶來中個位數的季增成長。關於毛利率，雖然 2026 年第一季因產品組合極為有利而表現出色，但我們仍預期 2026 年全年毛利率將較 2025 年全年小幅改善。短期內，產品與地區組合預期仍將有利。然而，我們將於 2026 年下半年啟用擴增後的製造設施，這將提高製造成本負擔，進而使全年毛利率展望趨於溫和。

Turning to operating expenses, as Mike mentioned, the accelerated timing for full enrollment in our BoxX-NoAF clinical trial has placed us significantly ahead of schedule, and we now expect full enrollment of the trial around the end of this year. As a result, over the next three quarters, we expect additional R&D investment. While the cost of BoxX-NoAF acceleration is incremental to our plan, we continue to drive strong gross margins and operating leverage reflecting discipline across our business. With that in mind, we are reiterating our expectations for full-year 2026 adjusted EBITDA of $80 million to $82 million and full year net income translating to earnings per share of approximately $0.00 to $0.04, and adjusted earnings per share of approximately $0.09 to $0.15.

談到營運費用，如同 Mike 提到的，我們 BoxX-NoAF 臨床試驗加速完成全面收案的時程，使我們的進度大幅超前，目前預期可在今年年底左右完成試驗全面收案。因此，在接下來三個季度，我們預期將增加額外的研發投資。雖然 BoxX-NoAF 加速所產生的成本屬於相較原計畫的增量，但我們仍持續推動強勁的毛利率與營運槓桿，反映出我們在整體業務上的紀律。基於此，我們重申對 2026 全年調整後 EBITDA 為 8,000 萬至 8,200 萬美元的預期，以及全年淨利換算每股盈餘約為 0.00 至 0.04 美元，調整後每股盈餘約為 0.09 至 0.15 美元。

Consistent with our 2025 performance, our quarterly outlook for adjusted EBITDA is largely informed by normal top-line cadence and the timing of R&D spend. As a reminder, 2025 R&D spending included LeAAPS enrollment costs for the first half of 2025 only. Therefore, we expect a slightly higher increase in R&D spending in the second half of 2026.

與我們 2025 年的表現一致，我們對每季調整後 EBITDA 的展望主要取決於正常的營收節奏，以及研發支出的時點。提醒一下，2025 年的研發支出僅在 2025 年上半年包含 LeAAPS 的收案成本。因此，我們預期 2026 年下半年的研發支出增幅會略高一些。

In conclusion, our first-quarter results highlight the durability of AtriCure innovation and continued improvement in our financial profile while funding investments in growth catalysts for the future. We remain energized by the opportunities in front of us and the exceptional AtriCure team who will make 2026 a success.

總結來說，我們第一季的結果凸顯了 AtriCure 創新的韌性，以及在投入未來成長催化劑的同時，我們的財務體質仍持續改善。我們對眼前的機會以及傑出的 AtriCure 團隊感到振奮，他們將讓 2026 年取得成功。

With that, I will turn the call back to Mike.

接下來，我把電話交回給 Mike。

Thanks, Angie. 2026 is off to a good start and our team is fully committed to our patients, our partners, and our shareholders. As we look ahead, we are confident in our ability to execute with discipline, sustain operational excellence, and build on the momentum that we have created. We look forward to delivering meaningful progress throughout 2026 and well beyond.

謝謝，Angie。2026 年開局良好，我們的團隊全力投入服務病患、合作夥伴與股東。展望未來，我們對自身以紀律執行、維持卓越營運並延續既有動能的能力充滿信心。我們期待在 2026 年以及更長遠的未來，持續交付具意義的進展。

And with that, I will turn it over to the Operator for any questions.

接下來，我把時間交給接線員，進行提問。

(Operator Instructions) Bill Plovanic, Canaccord Genuity.

(接線員指示) Bill Plovanic，Canaccord Genuity。

Hey, guys, it’s Zachary. Can you talk about the progress you are making on PFA integration, any milestones that we should be on the lookout for this year, and then can you talk quickly about the RF enhancements you are making to come with the next generation catheter?

嗨，各位，我是 Zachary。能否談談你們在 PFA 整合方面的進展、今年有哪些我們應該留意的里程碑？另外也請簡要說明一下，你們為下一代導管所做的 RF 強化。

Sure, I will take that on and appreciate the question. On the PFA, we are making great progress on that. We have done our first-in-human over in Australia so far. We are now starting first-in-human in Europe as well. It is not really first-in-human anymore, but we're going to be doing an additional 30 to 40 patients in Europe, and so that will obviously lead to our submission for the trial we expect to start running sometime next year.

好的，我來回答，也謝謝這個問題。關於 PFA，我們在這方面進展非常順利。我們目前已在澳洲完成首次人體試驗。我們也正開始在歐洲進行首次人體試驗。嚴格來說已不算真正的首次人體試驗，但我們將在歐洲再做額外 30 到 40 位病患，這顯然會推進我們的試驗申請，我們預期該試驗將在明年某個時間開始進行。

And so we are on pace doing great. No additional commentary at this point in time, but we are really pleased with the results we've seen so far and feel like there aren’t any specific milestones other than really submission to the FDA later on this year, acceptance of the IDE, and then beginning to enroll, as we kind of look into 2027 at some point in time. So we’ll give more details as we kind of get forward on that. We really wanted to focus today’s effort on obviously the great progress we’ve made on the BoxX-NoAF clinical trial because we’re so far ahead of plan that we wanted to make sure that we got that out there.

因此我們進度如期、表現很好。目前沒有更多補充，但我們對迄今看到的結果非常滿意；我們認為除了今年稍晚向 FDA 提交申請、IDE 獲受理，以及之後在某個時間點（展望 2027 年）開始收案之外，並沒有其他特定里程碑。我們會在進一步推進後提供更多細節。今天我們也希望把重點放在 BoxX-NoAF 臨床試驗的重大進展上，因為我們的進度大幅超前原計畫，所以想確保把這點對外說明。

300 patients in a very short period of time put us well over a year ahead of plan, and we thought that was just a big milestone for us as we kind of close out this year being able to finish up enrollment around the end of the year. That’s something we’re super excited about. As for the RF advancements, they are embedded in there. We’ve got both the RF and also the dual energy combined in some of those first in-human playbooks, and that’ll all be indicated and looking forward to kind of seeing that in trials sometime next year.

在很短的時間內完成 300 位病患收案，使我們的進度比原計畫超前超過一年；我們認為這是重要里程碑，因為我們有望在今年接近尾聲時、約在年底完成收案。這讓我們非常振奮。至於 RF 的進展，相關改良已包含在其中。在部分首次人體試驗的方案中，我們同時納入 RF 以及雙能量的組合；這些都會在試驗中呈現，我們也期待在明年某個時間於試驗中看到相關結果。

Matthew O’Brien, Piper Sandler. Your line is open.

Matthew O’Brien，Piper Sandler。您的線路已開通。

Afternoon. Thanks so much for taking the question. The first one, Mike, I know you can't grow this Pain Management business 30% every quarter, but just talk about what you saw in the quarter from a growth perspective in terms of new accounts, existing accounts with cryoSPHERE MAX, and then also on the ortho side of things. Just maybe the contributions that you got from those different buckets and how we should think about the growth trajectory for that business. Then I do have a follow-up.

下午好。非常感謝讓我提問。第一個問題，Mike，我知道你們不可能讓疼痛管理業務每季都成長 30%，但請談談本季從成長角度你們觀察到的情況：包括新客戶、既有客戶採用 cryoSPHERE MAX 的情形，以及骨科端的表現。也請談談這些不同來源的貢獻，以及我們應如何看待該業務的成長軌跡。我之後還有一個追問。

Yeah. I’ll start and just say that the cryo business, the pain business, as we talked about in our Analyst Day about a year ago, this is something that’s got multiple billion dollars of opportunity. Obviously, thoracic is an area that we’ve been established in for a long period of time. We’re now starting to see some traction on the sternotomy side, and we’re just starting on this, obviously below-the-knee amputation area. We’re just scratching the surface in my mind in all the areas that people undergo surgery and have a lot of pain afterwards, both from other parts of the body and other types of surgeries to looking into and researching the impact that you can have on actually phantom limb pain, which affects over 3 million people.

好的。我先說，冷凍消融業務、疼痛管理業務，正如我們大約一年前在分析師日所談到的，這是一個具備數十億美元機會的領域。顯然，胸腔領域是我們長期深耕的市場。我們現在也開始在胸骨正中切開（sternotomy）相關領域看到一些進展，而在膝下截肢這個領域，我們也才剛起步。在我看來，我們只是剛觸及表面：凡是人們接受手術且術後疼痛明顯的領域，不論是身體其他部位、其他類型的手術；我們也在探索與研究你能對幻肢痛（phantom limb pain）造成的影響，而這影響超過 300 萬人。

I mean, these are big, big numbers when you look at it. So we’ve got decades worth of growth in my mind here. Whether or not we can grow 30% for decades, obviously, the numbers get bigger and that becomes more difficult. But the good news is we’ve got multiple places to actually grow this market for many, many years to come.

我的意思是，從數字來看，這些都是非常、非常龐大的規模。因此在我看來，這裡有數十年的成長空間。至於是否能在數十年內都維持 30% 成長，顯然隨著基數變大會更困難。但好消息是，我們有多個方向可以實際推動這個市場在未來很多很多年持續成長。

With that, I’ll turn it over to Angie to give you some of the specifics on the numbers.

接下來，我把時間交給 Angie，請她提供一些數字上的細節。

Yeah, Matt, from an account perspective, we are about 70% of our Pain Management accounts have adopted cryoSPHERE MAX, and we continue to see every quarter since we’ve launched, we continue to see nice uptake. It was about 10% growth in the cryoSPHERE MAX accounts within the quarter. This is clearly becoming the dominant device that’s being used. I think surgeons are very compelled by the quick freeze times that they’re seeing and just exceptional outcomes for their patients.

好的，Matt，就帳戶面來看，我們約有 70% 的疼痛管理客戶已採用 cryoSPHERE MAX；自我們推出以來，每一季都持續看到良好的採用提升。本季 cryoSPHERE MAX 帳戶數約成長了 10%。這顯然正成為主要使用的裝置。我認為外科醫師對他們所看到的快速冷凍時間以及病患的卓越療效非常有感。

Got it. Thanks. That is great to hear. On BoxX-NoAF, in my experience, Mike or Angie, when these things enroll faster, it’s because doctors are seeing good outcomes. That’s why they’re doing more of these cases. Can you just talk about any kind of anecdotal feedback you’re getting from the clinicians as far as outcomes here, or kind of what’s expected from these outcomes? And then given the timeline for finishing enrollment, could we see -- because I think the follow-up’s pretty short, could we see data at ACC or HRS next year?

了解。謝謝。很高興聽到這個消息。關於 BoxX-NoAF，以我的經驗來看，Mike 或 Angie，當這些案子入組更快時，通常是因為醫師看到了良好的結果。這也是為什麼他們會做更多這類病例。你們能否談談臨床醫師那邊就結果（outcomes）所提供的任何軼事性回饋，或是這些結果大致上預期會是什麼樣子？另外，考量完成入組的時間表，我想追蹤期相當短，我們是否可能在明年 ACC 或 HRS 看到數據？

Yeah. Great question. I think you’re right that that is kind of what you said, we don’t have any specific information because it’s obviously a blinded trial. I don’t know exactly what’s happening within the trial relative to the individual patients, or the randomization on that front. That being said, we do know sites that have utilized this technology for their postoperative pain. We’ve seen it in all the preliminary work that went into going into the trial, and what we saw was significant reductions as a result of that. So much in fact that we have several sites, and it’s even more. We’ve got 5-plus sites or so that have decided to adopt this and will not come into the trial because they’re seeing such good results relative to using the EnCompass Clamp plus the AtriClip to see significant reductions in that.

是的。好問題。我想你說得對，正如你所提到的，我們沒有任何特定資訊，因為這顯然是一項盲性試驗。我不清楚試驗內個別病人的具體情況，或在隨機分派方面的狀況。不過，我們確實知道有些中心已經將這項技術用於術後疼痛管理。我們在進入試驗前的所有前期工作中都看到了這一點，而我們看到的是因此帶來顯著的降低。事實上，顯著到我們有好幾個中心，甚至更多。大約有 5 個以上的中心已決定採用這套方案，並且不會加入試驗，因為他們看到使用 EnCompass Clamp 搭配 AtriClip 能帶來顯著的降低效果。

If you look at the STS database, what you see is it’s about 35%-40% of all patients that undergo cardiac surgery, go into post-op AFib. Sometimes you’ll see up to 50% in some studies where you’ll see it as high as that. We’re seeing in the trials in different areas that it’s less than 10%. We don’t need that to win the trial, though, and to have a meaningful clinical impact on it. We feel really confident and really good about where this is going, and the result that we’ll wind up seeing. In terms of timing of results, you’re correct. We think it’s going to be around the end of the year based on the pace of enrollment we’re seeing right now.

如果你看 STS 資料庫，你會看到大約有 35%–40% 的心臟手術病人會在術後出現房顫（AFib）。有時在某些研究中甚至會看到高達 50%。而我們在不同領域的試驗中看到的比例低於 10%。不過，我們不需要達到那樣的數字也能贏得試驗，並對臨床產生有意義的影響。我們對這項進展以及最終會看到的結果感到非常有信心、也很樂觀。就結果時程而言，你說得沒錯。依照目前看到的入組速度，我們認為大約會在年底左右。

I said around because it could be sometime at the end of December or early January timeframe that we might have full enrollment in place. Then you’re right. We’ve got about 30 days of follow-up from that last patient. And then we’ll have to obviously adjudicate all of that data. So if you start to do the math as you just described, probably not HRS, more likely a surgical congress that we would do some sort of late breaker. The surgical congress that is out that late is AATS next year. If we got the data earlier, STS is in the January, February timeframe.

我說「左右」是因為可能會落在 12 月底或 1 月初左右，我們才會完成全部入組。然後你也說得對。從最後一位病人起算，我們大約有 30 天的追蹤期。接著當然還需要對所有資料進行判讀/裁定（adjudicate）。所以如果照你剛才那樣計算，可能趕不上 HRS，更可能是在某個外科年會做所謂的 late breaker 發表。明年時間較晚的外科年會是 AATS。如果我們更早拿到數據，STS 則是在 1 月、2 月左右。

Obviously, that is highly unlikely to make it that quickly, but we’re hopeful that we can conclude the trial, get those initial results, and get some data out there as a late breaker sometime at the AATS, which is around the same time as HRS next year.

顯然，要那麼快趕上是非常不可能的，但我們希望能完成試驗、取得初步結果，並在 AATS 的某個時間點以 late breaker 形式釋出一些數據；AATS 的時間大約也和明年的 HRS 差不多。

Marie Thibault, ETIG.

Marie Thibault，ETIG。

Hi, good evening. Wanted to spend a minute here on your international business. I think you called out some uncertainty on the UK side, which I know isn’t brand new, and also some lower distributor sales from APAC. So can you tell us a little bit more about what’s going on behind the scenes there, and any visibility on when things might start to improve? And then it sounds like the direct markets, OUS have been healthy, so just any more color on those markets as well.

嗨，晚安。我想花一點時間談談你們的國際業務。我記得你提到英國那邊有一些不確定性，我知道這不是什麼新消息，另外亞太地區（APAC）經銷商銷售也比較低。所以你能否多談一些背後實際發生了什麼，以及對於何時可能開始改善，你們是否有任何能見度？另外，聽起來你們的直營市場（OUS）表現健康，也請再多補充一些這些市場的情況。

Yeah, Marie, you called out the two kind of headwinds that we’re facing within our international business. The UK within Europe, we had anticipated that being a drag and talked, I think, at length within our guidance that we baked in a run rate that looks very similar to how we exited 2025. That held true for the first quarter of 2026 as we started the year. And just with our larger distributors in Asia, inherently distributor orders can be lumpy. We expect that pressure to be transient as we think about the rest of 2026. You mentioned it, but I’ll remind everybody, I’d say outside the headwinds, we saw really good growth in our franchises in our direct markets in Europe, Australia, and Canada.

是的，Marie，你點出了我們國際業務目前面臨的兩個主要逆風。英國在歐洲區域內，我們原本就預期會形成拖累，而且我想我們在財測指引中也談了不少：我們把一個與 2025 年底退出時相當類似的 run rate 納入假設。在 2026 年第一季、年初開始時，情況確實如預期。至於亞洲較大的經銷商，經銷商下單本來就可能有波動（lumpy）。我們認為，展望 2026 年其餘時間，這個壓力會是短暫的。你也提到了，我再提醒大家：撇除這些逆風之外，我們在歐洲、澳洲與加拿大等直營市場的各產品線（franchises）都看到非常不錯的成長。

We continue to be excited about bringing new products into each of those markets and seeing the progress that the teams are making there, and continue to focus on the NHS and making sure that our pain management device and then kind of any other budgetary pressures, what we can control that we are addressing quickly to get this market to a rebound. So guidance does not assume any kind of recovery in the UK, and then strong business other areas within Europe and the distributors in Asia that that’s expected to be transient again.

我們仍然很期待把新產品導入這些市場，也看到團隊在當地推進的進展；同時也會持續聚焦 NHS，確保我們的疼痛管理裝置，以及其他任何預算壓力中我們能掌控的部分，都能快速處理，讓這個市場回到反彈軌道。因此，我們的指引並未假設英國會有任何復甦；而歐洲其他地區的業務維持強勁，亞洲經銷商的波動則預期仍會是短暫的。

Okay, great detail. And then maybe my follow-up on the Convergent procedure side, I just wanted to understand how your view of that market has been evolving. Obviously, the PFA landscape has evolved quickly, so would just love an update on what you are seeing there on the ground.

好的，細節很清楚。接著我想追問 Convergent 手術（procedure）這一塊，我想了解你們對該市場的看法是如何演變的。顯然 PFA 的競爭態勢變化很快，所以很希望你能更新一下你們在第一線看到的情況。

Yeah, on the ground, we kind of talked about it very briefly during my remarks. There’s definitely a continued headwind in that area. What we’re seeing is the data is still incredibly strong, and these patients benefit from using the Convergent platform. That being said, they’re getting multiple PFA catheters first. They’re trying one, then another. Some are going up to three. That’s obviously delaying that pipeline and those patients coming through. That’s why it becomes tough to predict exact timing for us on that.

是的，就第一線來看，我在發言時其實很簡短地提過。那個領域確實仍有持續的逆風。我們看到的是，數據依然非常強勁，這些病人使用 Convergent 平台確實能受益。但話說回來，他們往往會先使用多支 PFA 導管。他們會先試一支，再試另一支。有些甚至會用到三支。這顯然會延後那條管線（pipeline）以及病人進入我們這邊的進程。這也是為什麼對我們而言，很難去精準預測其確切時點。

That being said, if you talk to most people that are actually using it, they actually do believe in it. They’re just seeing fewer patients, or they’re trying the catheter out one more time before they actually send that patient on. That’s the reality that we’re dealing with right now.

話雖如此，如果你去跟大多數實際在使用的人聊，他們其實是相信它的。他們只是看診的病人變少了，或者在真正把病人轉送出去之前，會再多嘗試一次導管。這就是我們目前正在面對的現實。

It’s why we’ve set the expectations as we have. But we really feel like those that are utilizing technology are getting incredible benefit, and we’re having lots of -- we continue to have lots of good conversations with the EPs, and we do think that it’s a solution that matters, and we have to continue to support.

這也是為什麼我們把預期設定成現在這樣。但我們確實覺得，那些正在使用這項技術的人獲得了極大的效益；而且我們也有很多——我們持續與電生理醫師（EPs）進行許多良好的對話，我們也確實認為這是一個重要的解決方案，我們必須持續支持。

Lilia‑Celine Lozada, JPMorgan.

Lilia‑Celine Lozada，摩根大通（JPMorgan）。

Hi, this is Henry on for Lilia. I just wanted to pivot a little bit to talk about the guidance. You were able to beat on the top line, and you reiterated the revenue guide. Can you talk a little bit more about why that’s not flowing through into the full year guide? And are there any headwinds in particular you’d like to call out for the remainder of 2026?

嗨，我是代替 Lilia 的 Henry。我想稍微轉個方向談一下財測指引。你們營收端表現優於預期，但仍重申了營收指引。能否再多談談，為什麼這沒有反映到全年指引上？另外，對於 2026 年剩餘期間，有沒有任何特別想點出的逆風因素？

I think that on the top line guide, we came in ahead of our expectations, both top and bottom line, a positive start to the year, but it is still early in the year and want to see continued outperformance before we revisit the guidance. I think that’s very much in line with our philosophy in tracking impact years. We are guiding to numbers that we feel very confident that we can achieve and look to beat and raise throughout the year. The headwinds we just touched on is primarily within our international business and then in our hybrid ablation business in the US, and in the areas of outperformance, very similar to what you saw in the first-quarter results, expecting continued really strong growth within our Pain Management franchise, our Open Ablation franchise, and Appendage Management as well.

我認為在營收指引方面，我們的表現確實高於預期，無論是營收端或獲利端；這是今年一個正向的開局，但現在仍是年初，我們希望在重新檢視指引之前，先看到持續的超預期表現。我想這非常符合我們在追蹤「影響年」（impact years）時的一貫理念。我們給出的指引數字，是我們非常有信心能達成，並且希望在全年過程中持續超越、上調的。至於剛剛提到的逆風，主要是在我們的國際業務，以及美國的混合消融（hybrid ablation）業務；而在超預期表現的領域，與你在第一季結果中看到的非常類似，我們預期疼痛管理（Pain Management）事業群、開放式消融（Open Ablation）事業群，以及心耳管理（Appendage Management）也將持續呈現非常強勁的成長。

Michael Matson, Needham.

Michael Matson，Needham。

Hi, Mike, Angie. Hope you two are doing well. This is Joseph on for Mike. Maybe just one on international first, China and Japan. I was wondering if you guys could just maybe give a broad overview on where you are now with the portfolio in terms of approvals or launches and maybe where that portfolio could sit in China and Japan by the end of this year.

嗨，Mike、Angie。希望你們兩位都一切順利。我是代替 Mike 的 Joseph。先問一個關於國際市場的問題，聚焦中國和日本。想請你們大致概述一下，目前產品組合在核准或上市進度上走到哪裡，以及到今年年底在中國與日本的產品組合可能會是什麼樣子。

Yeah, pretty comparable between both our China and Japan markets. You have the basic RF ablation devices. Neither market has EnCompass at this point in time. We just recently put our AtriClip in China, so that’s a newer product launch in that market.

好的，中國與日本兩個市場其實相當類似。你們有基本的射頻（RF）消融裝置。目前兩個市場都還沒有 EnCompass。我們最近才在中國導入 AtriClip，所以那是在該市場較新的產品上市。

And then within Japan, we’ve had different versions of our AtriClip on market and got expanded clearances for the Mini devices more recently there and are working on other product launches. I think with any market that you enter into, you’re looking at the product set and what the market can absorb given economic considerations, so on and so forth. But it is a subset of the overall products that we’ve got launched and are selling within the US market.

至於日本，我們先前已經有不同版本的 AtriClip 在市場上，最近也取得 Mini 裝置的擴大核准，並且正在推進其他產品上市。我認為進入任何市場時，你都會看產品組合，以及在經濟因素等考量下市場能吸收多少。但整體而言，這只是我們在美國市場已上市並銷售的全產品線中的一個子集合。

Okay, great. Makes sense. And then one on Appendage Management. So obviously a very strong year in 2025, and with new products, it’s looking good as well. But with the increased competition, it’s just, I guess, trying to get a handle on basically where they are, where your competitors are with trialing and incentives. Has that kind of steadied off? Are you seeing increased incentives for them to trial the product from your customers? Just trying to understand how these new entrants are affecting your sales or not affecting.

好的，很棒。了解。再問一個關於心耳管理（Appendage Management）的問題。顯然 2025 年表現非常強勁，而隨著新產品推出，看起來也很不錯。但在競爭加劇的情況下，我想掌握的是：基本上你們與競爭對手在試用（trialing）與誘因（incentives）方面目前各自處於什麼狀態。這種情況是否已經趨於穩定？你們是否看到客戶要求提供更多誘因來試用他們的產品？想了解這些新進者是否、以及如何影響你們的銷售。

Yeah. Just right now there’s only one entrant in the market, that’s Medtronic. They do have a product that we compete with today. And as I mentioned in my comments, what we saw was they kind of peaked in market share back in the kind of summer timeframe, late summer, early fall timeframe. And we’ve seen with FLEX Mini gaining more and more adoption at more and more sites that we’re actually gaining some of that share back. We still have the predominant market share in the United States.

是的。目前市場上其實只有一個新進者，就是美敦力（Medtronic）。他們確實有一個我們目前正在競爭的產品。如同我在評論中提到的，我們看到他們的市占率大概在夏季那段時間、也就是晚夏到初秋左右達到高峰。而隨著 FLEX Mini 在越來越多院所獲得採用，我們其實正在把其中一部分市占拿回來。我們在美國仍然擁有主導性的市占率。

We feel like the innovations that we put out there with FLEX-Mini, with PRO-Mini, with obviously clinical evidence that we’ll generate that will be very specific to our product, that we’re going to be in a very good place, both in terms of who we’re competing with right now and also, if Edwards does come into the market. Obviously they’ve mentioned that they’re gonna be coming into the market later on this year, and we will be ready for that. Again, the way that we know how to compete is to build the best products that are -- what the market really wants to meet those needs. We continue to innovate.

我們認為，透過 FLEX‑Mini、PRO‑Mini 所推出的創新，以及我們將產出的、非常針對我們產品的臨床證據，我們會處於非常有利的位置——不論是面對目前的競爭對手，或是如果 Edwards 真的進入市場。顯然他們已提到將在今年稍晚進入市場，而我們會做好準備。再次強調，我們知道的競爭方式，就是打造市場真正想要、能滿足需求的最佳產品。我們會持續創新。

On top of that, we’ve invested heavily in clinical evidence that’s very specific to our product, both in the LeAAPS and in the BoxX trial, which both include the appendage, looking for the benefits that we can get for stroke reduction on that that will be very specific to our product and our product only. And putting that level of evidence is something that none of the competition has actually started a trial down that pathway, and these are long trials, so it gives us a great deal of confidence in terms of the future for that.

此外，我們也在非常針對我們產品的臨床證據上投入大量資源，包括 LeAAPS 與 BoxX 試驗，兩者都涵蓋心耳，目標是證明我們在降低中風方面能取得的效益，而這些將會非常專屬於我們的產品、且僅限於我們的產品。而建立這種等級的證據，是目前沒有任何競爭對手真正沿著這條路徑啟動試驗的；而且這些都是長期試驗，因此讓我們對未來非常有信心。

So continue with the innovation, continue with the clinical evidence, gives us confidence that when competition comes in, whether it’s the ones that are out there, the ones that are talking about coming into the market, and there may be more in the future, that we are going to be incredibly well-positioned.

因此，持續創新、持續累積臨床證據，讓我們有信心：當競爭進入時——不論是已在市場上的、正在談論要進入市場的，或未來可能出現更多——我們都會處於極佳的競爭位置。

We also believe, as I’ve mentioned on this call before, that competition coming into the market means it’s a big market. It means that it's a multi-billion dollar market that can take on competition like this. All great markets in medical devices typically have several players in there, and we believe that that’s actually a really good sign that this is a big and robust market on the international scale.

我們也相信，正如我之前在這通電話會議中提到的，競爭者進入市場代表這是一個大市場。這意味著這是一個可容納此類競爭的、數十億美元規模的市場。醫療器材領域所有優質市場通常都會有多家業者參與，而我們相信這其實是一個非常好的訊號，顯示這在國際尺度上是一個龐大且具韌性的市場。

John McAulay, Stifel.

John McAulay，Stifel。

Hi, Mike and Angie. Just want to put a finer point on the 2026 guidance commentary you gave. Reiterating the top-line range and adjusted EBITDA range. Just want to understand the intention there as you beat on both. Would you expect that we let numbers for the rest of the year stay where they are to reflect the strength in the quarter or the hybrid and international headwinds you called out, will you expect that those sort of offset the $2 million of upside as we look ahead to the rest of 2026?

嗨，Mike 和 Angie。我想針對你們對 2026 年指引評論再更精準地追問一下。你們重申了營收區間與調整後 EBITDA 區間。因為你們兩者都超出表現，我想了解你們這麼做的用意。展望 2026 年剩餘期間，你們會預期讓全年其餘時間的數字維持在目前水準，以反映本季的強勁表現；還是你們提到的混合（hybrid）與國際業務逆風，會在我們看向 2026 年其餘時間時，抵銷那約 200 萬美元的上行空間？

Yeah, John, no different from our philosophy on guiding. We are putting out numbers that we believe we can not only meet, but that we’ve got a pathway to beat. I think with one quarter in, you’re still early in the year. Specific to the top line, felt like the right and prudent thing to do at this point in the year was just to hold the guide and expect that we’ve got the ability to outperform, no different than when we started the first quarter.

是的，John，這跟我們一貫的指引哲學沒有不同。我們給出的數字，是我們相信不僅能達成，而且有路徑可以超越的。我認為現在才第一季結束，年初仍然算早。就營收而言，在這個時間點，採取維持指引、並預期我們有能力優於指引，是正確且審慎的作法，這跟第一季一開始時的做法並無不同。

On the bottom line, I’d say more of a shift in we are with the pace of enrollment on BoxX-NoAF, those costs are incremental. Pulling enrollment in by a year into 2026, that is incremental to our plan in 2026 for the full year. We had a very strong margin, gross margin in the first quarter. Expect for there to be improvement over 2025.

至於獲利端，我會說更多是因為 BoxX-NoAF 的收案（enrollment）進度所帶來的變化，那些成本是增量成本。把收案提前一年拉到 2026 年，對我們 2026 全年的原先計畫而言是額外增加的。我們第一季的毛利率表現非常強勁。預期相較 2025 年會有所改善。

But that being said, some of the favorability on the margin side is transient, again, with the mix of the international business primarily. You take that kind of whole calculus, and the diligence that we’re seeing across the business to see improvement in leverage, that positioned us really well to be able to absorb the additional trial costs and hold the bottom line guide where it’s at. And again, no different are putting numbers out there we expect not only to meet, but to beat.

但即便如此，毛利率端的一些有利因素是短暫的，主要仍與國際業務的組合（mix）有關。把這些因素整體納入考量，再加上我們在全公司看到為改善槓桿（leverage）所做的嚴謹管理，讓我們能夠很好地吸收額外的試驗成本，同時把獲利端指引維持在目前水準。同樣地，我們給出的數字不僅預期能達成，也預期能超越。

That’s helpful. And just make sure I’m understanding the dynamics of OUS. So in the quarter you highlighted 3.3% constant currency growth. Is that what we should be expecting for the year ahead, or what are the drivers of acceleration or re-acceleration we should be looking at in that business?

這很有幫助。另外我想確認我對 OUS（美國以外）動能的理解。所以本季你們提到以固定匯率計算成長 3.3%。這會是我們對未來一年應該預期的水準嗎？或者在那個業務中，我們應該關注哪些會帶來加速或再加速的驅動因素？

Yeah. Good question. I’d say, we are expecting our international business to grow on a reported basis closer in line to the overall company guide, so that’d be kind of double-digit growth for our international business. You saw more favorability from a currency in the first quarter. Expect for that to wane a bit as we think about the rest of the year. You know, strength in our direct markets in Europe, we expect for that to be a continued driver there. You’ve got newer product launches in that market, EnCompass is a big driver in our European market, and then a bit of a rebound in our Asia distributors. Again, I think ordering patterns can be kind of lumpy there, so expecting that to rebound as well.

是的。好問題。我會說，我們預期國際業務以報表口徑（reported basis）來看，成長會更接近公司整體指引，也就是國際業務大約會是雙位數成長。你在第一季看到匯率帶來較多的有利影響。我們預期隨著進入今年剩餘期間，這個影響會稍微減弱。你知道，在歐洲的直營市場表現強勁，我們預期這會持續成為驅動因素。該市場也有較新的產品上市，EnCompass 是我們歐洲市場的一個重要驅動因素，另外我們在亞洲的經銷商也會有一些回升。同樣地，我認為那邊的下單型態可能會比較不均勻（lumpy），所以也預期會回升。

And that’s the calculus to get to kind of that mid double-digit growth expectation for the year.

而這些因素綜合起來，就形成我們對全年約中段雙位數成長的預期。

Thanks, Angie. Appreciate it.

謝謝你，Angie。感謝。

Danny Stauder, Citizens.

Danny Stauder，Citizens。

Yeah. Great. Thanks for the questions. This first one on pain management. Great to see the strong quarter. You noted improved market penetration in thoracic and sternotomy. Just on the latter of the two, it’s nice to hear you’re starting to see traction, but was just curious what was driving this of late. We’ve talked about sternotomy and that opportunity for a bit now, so I just wanted to see if there was any newer developments that’s leading to this.

是的。很好。謝謝讓我提問。第一個問題關於疼痛管理。很高興看到本季表現強勁。你們提到在胸腔（thoracic）與胸骨正中切開術（sternotomy）的市場滲透率提升。就後者而言，很高興聽到你們開始看到進展，但我想了解最近是什麼在驅動這件事。我們談 sternotomy 這個機會已經一段時間了，所以我想看看是否有任何較新的進展促成了這樣的結果。

Yeah. Great question. I think what you’re seeing here, Danny, is that you’re seeing it works in sternotomy. It just takes a little bit longer to get there. With the Max product that has reduced the time in half, that really has improved adoption and the willingness of somebody to even try it. Once they try it, they see really good results pretty quickly, it becomes a lot more sticky at that point in time. I’d say that’s really what you’re seeing. It’s not something that you’ll ever get a hockey stick curve off of, I don’t believe, but I think that you’re gonna continue to see nice, robust growth within this area as we add more and more accounts. We’ve got many accounts that are actually doing this now.

是的。好問題。Danny，我認為你在這裡看到的是：它在 sternotomy 上確實有效。只是需要更長一點時間才能達到那個程度。Max 產品把時間縮短了一半，這確實提升了採用率，也提高了人們願意嘗試的意願。一旦他們嘗試後，很快就能看到非常好的結果，到了那個時點就會變得更具黏著度。我會說你看到的主要就是這些。我不認為它會出現所謂的「曲棍球棒」式爆發成長，但我認為隨著我們新增越來越多的客戶，你會持續看到這個領域良好且強勁的成長。我們現在其實已經有很多客戶在做這件事了。

It’s no longer just a handful across the country. People are talking to each other. They’re talking about the results, whether it’s at trade shows or other places like that, or peer-to-peer conversations. That’s really what’s driving it.

不再只是全國少數幾家而已。大家彼此在交流。他們在談論結果，不管是在展會或其他場合，或是同儕之間的一對一交流。這才是真正的驅動因素。

Okay, great. Then just one follow-up on the STS quality metric update. Could you give us a little more color on this? You know, first one, we’ll start, should we be thinking of this more as a longer tail of growth over the next few years versus a more near-term uptick? Just any more information on how we should think about this in terms of incremental adoption or just frame the potential revenue opportunity here would be really helpful.

好的，很好。接著追問一個關於 STS 品質指標更新的問題。你能否再提供一些細節？首先，我們應該把這視為未來幾年較長尾的成長，還是較偏向短期的上升？任何更多資訊，關於我們應如何看待這在增量採用上的影響，或是如何框架這裡潛在的營收機會，都會非常有幫助。

Sure. I’ll start by saying, just a reminder to everybody that in the US, about 35% of all patients that have AFib that undergo cardiac surgery actually get an ablation. So that is obviously a very low number. You still have 65% left to go. The quality metric is meant to address that.

當然。我先提醒大家，在美國，大約只有 35% 的房顫（AFib）患者在接受心臟手術時，實際上會進行消融（ablation）。所以這顯然是一個非常低的比例。還有 65% 的空間。品質指標就是要處理這件事。

It’s meant to say that what they put out there was that there’d be 70% of the patients actually get treated. That number will likely grow. That was the commentary that was at STS back in January of this year. They anticipate that they’ll put some teeth into it. They wanted to roll out that this is becoming a quality metric, and that quality metric will go into effect sometime in 2027, at which point in time there’ll be some teeth in it in terms of they’ll be measured on it. It will be recorded in the STS database.

它的用意是：他們提出的目標是讓 70% 的患者實際接受治療。那個數字很可能還會提高。這是他們在今年 1 月的 STS 上所做的評論。他們預期會讓它更具約束力。他們希望先推出「這將成為一項品質指標」，而該品質指標會在 2027 年的某個時間點生效，屆時在「會被用來衡量」這件事上就會更具約束力。它也會被記錄在 STS 資料庫中。

How that all -- the specifics behind that are still not disclosed yet by STS, but that is coming out. To give you some perspective, I mentioned in the call that previously, the last time they did any kind of therapeutic view like this, it was the LIMA to the LAD, and that when they made it a quality metric, it went from about 10% adoption up to 99.8% adoption or so today.

至於其運作方式——背後的具體細節目前 STS 仍尚未披露，但之後會公布。給各位一些背景，我在電話會議中提到，先前他們上一次做出這類治療觀點的指引時，是針對 LIMA 接到 LAD；而當他們把它納入品質指標後，採用率就從約 10% 提升到如今大約 99.8% 左右。

So quality metrics matter. They make a difference. People look at them. Hospitals look at them. They affect their ratings.

所以品質指標很重要。它們會帶來差異。大家會看這些指標。醫院也會看。它們會影響醫院的評等。

So we do anticipate that on the AFib side of things, we should see some uplift relative to the AFib side in 2027 as they’re kind of rolling this out. Obviously, that will continue into 2028 and beyond. We think that’s going to be a big boon and positive force on the ablation side to improve that penetration from 35% in the US to hopefully, obviously, getting it closer to 80%, 90% or so at some point over the next three to five years. So we’ve got a lot of room for growth. This is a little bit of, I don’t know, you can call it a carrot or a stick, depending on how you wanna look at it, but it’s an incentive either way for people to do the treatment.

因此我們預期，在房顫（AFib）這一端，隨著他們在 2027 年逐步推行，我們應該會看到相對於房顫端的一些提升。顯然，這也會延續到 2028 年及之後。我們認為這將成為一股重大助力與正向力量，推動消融治療端的滲透率提升，從美國目前的 35% 希望在未來三到五年某個時間點，顯然能把它拉近到 80%、90% 左右。所以我們還有很大的成長空間。這有點像——我不知道，你可以稱之為胡蘿蔔或棍子，取決於你怎麼看，但不管怎樣，對大家去做這項治療都是一種誘因。

On top of that, obviously, we’re going to have data that comes out on the non-AFib patients, and we believe you combine that with the quality metrics and the fact that the EnCompass Clamp is so easy to use, that we will start to see some really nice adoption overall over the next three to five years in a big way.

此外，顯然我們也會有針對非房顫患者的數據出爐；我們相信把這些數據與品質指標結合，再加上 EnCompass Clamp 非常容易使用，我們將在未來三到五年看到整體採用率以很大的幅度出現相當不錯的提升。

Keith Hinton, Freedom Capital Markets.

Keith Hinton，Freedom Capital Markets。

Great. Just have a quick one on AtriClip. Can you just talk a little bit -- and I apologize if I missed this, I’m jumping around a little bit, but can you talk a little bit about the use of Flex Mini versus the prior generations in open appendage? More broadly, can you just talk about the current ASP for AtriClip in the US and how we should think about those dynamics going forward as uptake continues for Flex and PRO-Mini?

很好。我有一個關於 AtriClip 的簡短問題。你能否稍微談一下——如果我漏聽了先說聲抱歉，我有點跳著問——在開放式心耳（appendage）手術中，Flex Mini 相較於前幾代產品的使用情況？更廣泛地說，你能否談談目前 AtriClip 在美國的平均銷售價格（ASP），以及隨著 Flex 和 PRO-Mini 的採用持續提升，我們應該如何看待未來這些動態？

Yeah, I’ll take this one. The AtriClip FLEX-Mini, what we are seeing is pretty steady conversion from our last generation AtriClip device, the AtriClip FLEX-V, less so from the original AtriClip device, which is still on the market. Between the three products, you’ve got different price points, and you’ve also got the ability for a surgeon to choose depending on the approach that they wanna take for managing the appendage. Exiting the first quarter 2026, we were up to about 40% of the revenue in the US in open appendage management in the FLEX-Mini clip. We exited last year a little over 35%, so we continue to see steady share gains by that new product launch.

好的，這題我來回答。AtriClip FLEX-Mini 方面，我們看到從上一代 AtriClip 裝置（AtriClip FLEX-V）轉換過來的趨勢相當穩定；相較之下，從最初代 AtriClip 裝置（目前仍在市場上）轉換的比例較少。這三個產品之間有不同的價格帶，同時也讓外科醫師可以依其想採取的心耳處置方式來選擇。截至 2026 年第一季結束時，在美國的開放式心耳管理業務中，FLEX-Mini 夾的營收占比約提升到 40%。去年年底我們略高於 35%，因此我們持續看到這項新產品上市帶來穩定的市占提升。

And from an ASP perspective, we’re well-positioned by offering a range here as low as $1,100 with the original AtriClip device for accounts where pricing is a sensitivity, and the FLEX-Mini clip up to $2,250.

就 ASP 而言，我們透過提供一個區間而具備良好布局：對於對價格較敏感的客戶，我們有最初代 AtriClip 裝置，最低可到 1,100 美元；而 FLEX-Mini 夾最高可到 2,250 美元。

I am showing no further questions at this time. I would now like to turn the call back to Mike Carrel for closing remarks.

目前沒有其他問題。現在我想把電話交回給 Mike Carrel 作結語。

Great. Well, just wanted to thank everybody for joining for the call today after an exciting Q1, and what’s starting to be a great 2026 overall. Thank you for joining. We appreciate it, and we look forward to talking to you again in July. Talk to you soon.

很好。在第一季表現令人振奮之後，我只想感謝各位今天加入這場電話會議，也看到 2026 年整體正開始成為非常出色的一年。感謝各位參與。我們非常感激，也期待在七月再次與各位交流。我們很快再談。

This concludes the question and answer session. This concludes today’s conference call as well. Thank you for participating. You may now disconnect.

問答環節到此結束。今天的電話會議也到此結束。感謝各位參與。您現在可以掛線。