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
Sam Bentzinger - Investor Relations
Sam Bentzinger - Investor Relations
Good afternoon, and thank you for joining the call today. With me from Tactile's management team are Sheri Dodd, Chief Executive Officer; and Elaine Birkemeyer, Chief Financial Officer.
各位下午好,感謝您今天參加本次電話會議。與我一同出席的 Tactile 管理團隊成員包括:執行長 Sheri Dodd,以及財務長 Elaine Birkemeyer。
Before we begin, I'd like to remind everyone that our remarks and responses to your questions today may contain forward-looking statements that are based on the current expectations of management and involve inherent risks and uncertainties. These could cause actual results to differ materially from those indicated, including those identified in the Risk Factors section of our annual report on Form 10-K, as well as our most recent 10-Q filing to be filed at the Securities and Exchange Commission.
在開始之前,我想提醒各位,我們今天的發言以及對您提問的回覆可能包含前瞻性陳述,該等陳述係基於管理層目前的預期,並涉及固有風險與不確定性。這些因素可能導致實際結果與所示結果出現重大差異,包括我們 Form 10-K 年度報告之「風險因素」章節所識別者,以及我們最近向美國證券交易委員會提交(或將提交)的 Form 10-Q 季報文件中所載者。
Such factors may be updated from time to time in our filings with the SEC, which are available on our website. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events, or otherwise.
相關因素可能會不時在我們向 SEC 提交的文件中更新,該等文件可於我們網站取得。除非法律另有規定,因新資訊、未來事件或其他原因,我們不承擔公開更新或修訂任何前瞻性陳述之義務。
This call will also include references to certain financial measures that are not calculated in accordance with generally accepted accounting principles or GAAP. We generally refer to these as non-GAAP financial measures. Reconciliations of those non-GAAP financial measures to most comparable measures calculated and presented in accordance with GAAP are available in the earnings press release on the Investor Relations portion of our website.
本次電話會議亦將提及若干並非依一般公認會計原則(GAAP)計算之財務衡量指標。我們通常將其稱為非 GAAP 財務衡量指標。該等非 GAAP 財務衡量指標與依 GAAP 計算並呈列之最可比衡量指標之調節表,已刊載於我們網站「投資人關係」專區的財報新聞稿中。
With that, I'll now turn the call over to Sheri.
接下來,我將把電話會議交給 Sheri。
Sheri Dodd - Chief Executive Officer, Director
Sheri Dodd - Chief Executive Officer, Director
Thanks, Sam. Good afternoon, everyone, and welcome to our first-quarter 2026 earnings call. Here with me is Elaine Birkemeyer, our Chief Financial Officer.
謝謝你,Sam。各位下午好,歡迎參加我們 2026 年第一季財報電話會議。與我一同出席的是我們的財務長 Elaine Birkemeyer。
We are pleased to report a strong start to 2026, with first-quarter results reflecting focused execution of our three strategic priorities, continued strength and durability of our commercial action plan, and operational excellence, including preparing for recent changes regarding the introduction of prior authorization for Medicare fee-for-service patients.
我們很高興報告 2026 年開局強勁,第一季業績反映我們對三項策略優先事項的聚焦執行、商業行動計畫持續展現的強度與韌性,以及營運卓越表現,其中包括為近期針對 Medicare 傳統按服務計費(fee-for-service)患者導入事前授權(prior authorization)的變更做好準備。
Specifically, in Q1, we delivered total revenue of $75.3 million, representing growth of 23% year over year. By business line, lymphedema revenue grew 23% year over year to $62.2 million and airway clearance revenue increased 22% year over year to $13 million. Q1 results include a minimal contribution from our recent acquisition, LymphaTech.
具體而言,第一季我們達成總營收 7,530 萬美元,年增 23%。按業務線別,淋巴水腫營收年增 23% 至 6,220 萬美元;呼吸道清除(airway clearance)營收年增 22% 至 1,300 萬美元。第一季結果僅包含我們近期收購案 LymphaTech 的極小貢獻。
Our revenue performance reflects continued strategy and execution against key revenue drivers: our phase technology and people go-to-market investments, which drive referrals and market share; NCD-related tailwinds, which drive favorable advanced pump product mix; depth and breadth of our DME relationships, which drive market expansion and share; and not to be understated, disciplined operational execution across the enterprise.
我們的營收表現反映持續的策略與對關鍵營收驅動因素的執行:我們在 phase 技術與人員的市場推進(go-to-market)投資,帶動轉介與市占;與 NCD 相關的順風因素,推動有利的高階幫浦產品組合;我們 DME 關係的深度與廣度,帶動市場擴張與市占提升;以及同樣不可忽視的,全企業範圍內嚴謹的營運執行。
Further, top-line strength drove meaningful margin expansion. Gross margins increased 250 basis points to 76.5% and adjusted EBITDA increased $4 million year over year to $3.7 million. We ended the first quarter with approximately $75 million in cash, maintaining substantial financial flexibility as we continue to invest for long-term growth.
此外,營收端的強勁表現帶動顯著的毛利率擴張。毛利率提升 250 個基點至 76.5%,調整後 EBITDA 年增 400 萬美元至 370 萬美元。我們在第一季末持有約 7,500 萬美元現金,維持充足的財務彈性,以持續投入長期成長。
For 2026, we are updating our full-year revenue guidance to a range of $360 million to $368 million. This update reflects the inclusion of LymphaTech and our increased confidence in commercial execution while maintaining a disciplined approach as prior authorization outcomes under new Medicare requirements for our category continue to mature.
針對 2026 年,我們將全年營收指引更新至 3.60 億至 3.68 億美元區間。此更新反映納入 LymphaTech 的影響,以及我們對商業執行的信心提升;同時,在新 Medicare 規定下、針對本類別的事前授權結果仍在逐步成熟之際,我們仍維持審慎且有紀律的做法。
For the remaining of the call, I will review our Q1 performance by business line and then provide updates on our ongoing strategic priorities. Elaine will follow with a review of our first full quarter financial results and an update on our outlook for 2026.
在接下來的會議中,我將先按業務線回顧第一季表現,並就我們持續推進的策略優先事項提供最新進展。之後 Elaine 將回顧我們第一個完整季度的財務結果,並更新 2026 年展望。
Turning first to lymphedema. Revenue grew 23% year over year in Q1. We are pleased to see this significant growth compared to last year, which was expected given the momentum of our field and back-office strategy execution.
首先談淋巴水腫業務。第一季營收年增 23%。我們很高興看到相較去年如此顯著的成長,這也符合預期,主要來自我們前線與後勤策略執行所累積的動能。
Our go-to-market investments are delivering. Our sales organization is fully resourced, with broad geographic coverage and a well-balanced staffing model of approximately one account manager for every product specialist. With those resources in place, we are shifting our focus from capacity investment and onboarding to productivity and operating leverage.
我們的市場推進投資正在產生效果。我們的銷售組織已全面到位,具備廣泛的地理覆蓋,且人力配置模式均衡,約為每一位客戶經理(account manager)對應一位產品專員(product specialist)。在資源到位後,我們正將重心從產能投資與新人導入,轉向提升生產力與營運槓桿。
Territory productivity increased meaningfully in Q1 year over year. Robust CRM utilization, combined with continued enhancements including workflow tools, is increasingly supporting referral management, prioritization, and account development, and we expect continued territory optimization and sustained productivity gains over time.
第一季各區域(territory)生產力較去年同期顯著提升。強勁的 CRM 使用率,加上持續的強化(包括工作流程工具),正日益支援轉介管理、優先順序設定與客戶開發;我們預期隨時間推進,區域最佳化將持續,生產力也將維持提升。
From a products perspective, overall lymphedema growth in the quarter was supported by both Nimbl and Flexitouch, with Flexitouch growth outpacing Nimbl.
從產品面來看,本季整體淋巴水腫成長同時受 Nimbl 與 Flexitouch 帶動,其中 Flexitouch 的成長速度高於 Nimbl。
As expected, this dynamic was largely tied to our decision in October of 2025 to align our advanced pump documentation criteria with the Medicare NCD. While this alignment had always been planned, the timing reflected our increasing confidence that the max administration of the NCD had stabilized.
如同預期,這一動態主要與我們在 2025 年 10 月所做的決策有關:將我們高階幫浦(advanced pump)的文件標準與 Medicare 的 NCD 對齊。雖然此對齊原本就已規劃,但時點反映我們對 NCD 的管理已趨於穩定的信心提升。
Importantly, the NCD has created a more direct and clinically aligned pathway for patients who require advanced pump therapy compared to the prior LCV policy. This will continue to be a tailwind for Flexitouch volume as we continue to educate providers on the policy change and drive the right patient, right pump messaging.
重要的是,相較於先前的 LCV 政策,NCD 為需要高階幫浦治療的患者建立了更直接且更符合臨床的途徑。隨著我們持續教育醫療提供者了解政策變更,並推動「對的病人、對的幫浦」訊息,這將持續成為 Flexitouch 銷量的順風因素。
Notably, the NCD policy language also allows for advanced pump coverage for patients with head and neck lymphedema, and we are pleased to see increasing clinical adoption of Flexitouch for these underserved patients who have no other pneumatic or non-pneumatic compression device options.
值得注意的是,NCD 的政策文字亦允許頭頸部淋巴水腫患者獲得高階幫浦給付;我們也很高興看到 Flexitouch 在這些長期服務不足的患者族群中臨床採用率提升,因為他們沒有其他氣動或非氣動壓縮裝置的選擇。
This NCD-driven Flexitouch strength was also evident in our Q1 payer mix, with sales in our Medicare channel growing 40% year over year. To a smaller extent, Medicare's strength also reflects some order acceleration ahead of the April 13 effective date for the new prior authorization requirements for PCDs billed under traditional Medicare fee-for-service. Importantly, underlying demand remains healthy. And as the new prior authorization process settles, we expect quarterly ordering patterns to normalize.
這項由 NCD 驅動的 Flexitouch 強勁表現,也反映在我們第一季的付款方組合中:Medicare 通路銷售年增 40%。在較小程度上,Medicare 的強勁也反映部分訂單在 4 月 13 日新事前授權要求(適用於在傳統 Medicare 按服務計費下申報的 PCD)生效前提前下單。重要的是,基本需求仍然健康。隨著新的事前授權流程逐步穩定,我們預期各季度的下單型態將回歸常態。
As a reminder, the inclusion of the prior authorization process for basic and advanced PCDs for Medicare patients was announced in January of 2026 and aligns with Medicare's prior authorization decisions in other growing D&E categories.
提醒各位,針對 Medicare 患者之基本與高階 PCD 納入事前授權流程,已於 2026 年 1 月宣布,並與 Medicare 在其他成長中的 D&E 類別所做的事前授權決策一致。
During our Q4 call, we discussed our expectation that this new requirement will add additional steps to the order process, such as assembling and submitting a prior authorization documentation packet and checking the status of each submission in order to process the claim. Additionally, these new requirements require patients to have face-to-face clinical visits with a treating physician, not just therapists, to establish and document medical necessity.
在第四季電話會議中,我們曾討論預期此新要求將為訂單流程增加額外步驟,例如彙整並提交事前授權文件包,以及查核每次提交的狀態以便處理理賠。此外,這些新要求也規定患者必須與治療醫師進行面對面臨床就診,而不僅是治療師,以建立並記錄醫療必要性。
To be ready for the go-live date, we accelerated the prior authorization module in our AI portfolio, which had originally been planned for launch in 2027. In the weeks leading up to April 13, we demonstrated operational agility in validating the technology and systems, training and staffing our teams, and successfully deploying a new process on schedule.
為了準備上線日期,我們加速推出 AI 產品組合中的事前授權模組,該模組原本規劃於 2027 年上市。在 4 月 13 日前的數週,我們展現營運敏捷性,完成技術與系統驗證、團隊訓練與人力配置,並成功按期部署新流程。
The Medicare PCD prior authorization requirement has been in place for just three weeks. We are actively managing early transition dynamics as both we and the MACs adjust our respective processes. As an industry leader and a DME provider with extensive experience operating in other prior authorization environments across Medicare Advantage and commercial plans, we believe we are well-positioned to support patients through this transition.
Medicare 的 PCD 事前授權要求實施至今僅三週。我們正積極管理早期轉換期的動態,因為我們與 MACs 皆在調整各自流程。作為產業領導者,以及在 Medicare Advantage 與商業保險等其他事前授權環境中具備豐富營運經驗的 DME 供應商,我們相信自身具備良好條件,能在此轉換期間支援患者。
Turning to our other payer channels, our commercial business remains healthy and is demonstrating quarter-over-quarter consistency. In the VA channel, performance reflects a different operating and growth profile than Medicare and commercial. Unlike those channels where reimbursement policies are more dynamic and have driven more pronounced year-over-year comparisons, the VA reimbursement environment is notably more stable, which naturally results in less quarter-to-quarter volatility.
再看其他付款方通路,我們的商業保險業務仍維持健康,並展現季度對季度的一致性。在 VA 通路方面,其表現反映與 Medicare 與商業保險不同的營運與成長輪廓。不同於那些通路的給付政策較為動態、因而帶來更明顯的年對年比較,VA 的給付環境顯著更為穩定,因此自然呈現較低的季度波動。
From a commercial execution standpoint, the VA call point spans a diverse set of specialties, including vascular, oncology, and therapy practices, with success driven by sustained relationship-based engagement and navigation of local VA systems. As our recently expanded field organization continues to deepen engagement, establish workflows, and build trusted relationships within these accounts, we expect the VA to become a more meaningful contributor over time.
從商業執行的角度來看,VA 的拜訪觸點涵蓋多元專科,包括血管、腫瘤與治療相關診所;成功的關鍵在於持續以關係為基礎的互動,以及對各地 VA 系統的導引與運作熟悉。隨著我們近期擴編的前線組織持續深化互動、建立工作流程,並在這些客戶中建立受信任的關係,我們預期 VA 將隨時間推移成為更具意義的貢獻來源。
We view the VA as a strategic long-term opportunity that is well-aligned with our evolving portfolio and an incremental growth contributor alongside our Medicare and commercial channels, with growth unfolding in a deliberate and durable manner.
我們將 VA 視為一項具策略性的長期機會,與我們持續演進的產品組合高度契合,並可在 Medicare 與商業通路之外,帶來額外的增量成長貢獻;其成長將以審慎且可持續的方式逐步展開。
Turning now to airway clearance. Sales of AffloVest increased 22% year over year in the first quarter. The key drivers of our robust performance remain consistent with what I have shared previously. Our relationships with the top respiratory DMEs remain strong, including at the C-Suite, and AffloVest continues to be well-placed across these accounts.
接著談到氣道清除(airway clearance)。第一季 AffloVest 的銷售額年增 22%。我們強勁表現的關鍵驅動因素,與我先前分享的內容一致。我們與頂尖呼吸類 DME(耐用醫療設備)業者的關係依然穩固,包括在高階管理層(C-Suite)層級;AffloVest 也持續在這些客戶中維持良好佈局。
There are additional opportunities to deepen engagement within our top 10 DME partners, given the breadth and scale of their national footprints and alignment of individual branch performance goals. We are committed to delivering high-quality medical education and training for providers and DME staff, supporting sales skills of AffloVest and airway clearance therapies at the DME national and area sales meetings, manufacturing a superior airway clearance product, and providing AffloVest account manager continuity to our DME partners, all of which we believe are critical inputs to driving consistent growth and valued partner status.
鑑於我們前 10 大 DME 合作夥伴具備廣泛且具規模的全國據點,以及各分支機構績效目標的一致性,我們仍有進一步深化合作的機會。我們致力於提供高品質的醫學教育與訓練給醫療提供者與 DME 人員,在 DME 全國與區域銷售會議中支持 AffloVest 與氣道清除療法的銷售技能,製造更優異的氣道清除產品,並為 DME 合作夥伴提供 AffloVest 客戶經理的延續性;我們相信,這些都是推動穩定成長並成為受重視合作夥伴的關鍵投入。
As the market leader in airway clearance therapy, we remain focused on serving the millions of diagnosed and undiagnosed bronchiectasis patients in the US. We expect our commercial strategy, clinical education efforts, and strong DME partnerships to continue driving growth throughout the year, in addition to the launch of our next-generation AffloVest product, which I'll touch on shortly.
作為氣道清除療法的市場領導者,我們仍專注於服務美國數以百萬計已確診與未確診的支氣管擴張症患者。我們預期商業策略、臨床教育投入,以及強健的 DME 夥伴關係,將在全年持續帶動成長;此外,我們也將推出下一代 AffloVest 產品,我稍後會再提及。
We are committed to evolving our lymphedema strategy for growth from that of a product company to an integrated solutions leader for lymphatic dysfunction, and the acquisition of LymphaTech is an important milestone in this exciting evolution. LymphaTech sits squarely within our strategy to support patients across the full continuum of care, which begins with getting an accurate, timely, and objective lymphedema diagnosis. LymphaTech's 3D measurement and monitoring platform addresses this need directly, replacing traditional manual measurement methods that are time-consuming, highly variable, and dependent on clinician technique.
我們致力於推動淋巴水腫策略的成長轉型,從單純的產品公司,進一步成為淋巴功能障礙的整合式解決方案領導者;而收購 LymphaTech 是這項令人振奮演進的重要里程碑。LymphaTech 完全契合我們支持患者全照護連續體的策略,而這一切始於取得準確、及時且客觀的淋巴水腫診斷。LymphaTech 的 3D 測量與監測平台可直接滿足此需求,取代傳統手動量測方式;後者不僅耗時、變異性高,且高度依賴臨床人員的操作技術。
Currently, the LymphaTech platform is FDA-cleared and commercially available as a SaaS-based solution. As we shared last quarter, a key element of this acquisition is broadening our R&D capabilities to support next-generation approaches to disease assessment and treatment, and we look forward to sharing updates on our progress in the quarters ahead.
目前,LymphaTech 平台已取得 FDA 核准(cleared),並以 SaaS(軟體即服務)解決方案形式商業化提供。如同我們上季所分享,此次收購的一項關鍵要素,是擴大我們的研發能力,以支持下一代疾病評估與治療方法;我們也期待在未來幾季分享進展更新。
The integration is progressing as planned since closing in February. The LymphaTech co-founders and team are actively contributing to both the go-to-market commercialization strategy as well as helping to identify the capabilities and integration points across the diagnostic and therapy product development road maps. We are being deliberate and strategic in our approach to maximizing the provider, clinician, and patient experience.
自 2 月完成交割以來,整合工作正按計畫推進。LymphaTech 的共同創辦人與團隊正積極投入上市(go-to-market)商業化策略,同時協助辨識診斷與治療產品開發藍圖之間的能力與整合切入點。我們以審慎且具策略性的方式,致力於最大化醫療提供者、臨床人員與患者的整體體驗。
Beyond the team and the technology, LymphaTech also recently earned selection as a funding recipient under a new federal research program focused on lymphatic disease. Specifically, the Advanced Research Project Agency for Health recently announced two landmark programs, LIGHT and GUIDE, committing a combined more than $290 million across all awardees over five years to advance lymphatic diagnosis and therapeutics.
除團隊與技術之外,LymphaTech 近期也獲選為一項聚焦淋巴疾病的新聯邦研究計畫之資助受款者。具體而言,健康先進研究計畫署(Advanced Research Project Agency for Health)近期宣布兩項具里程碑意義的計畫 LIGHT 與 GUIDE,承諾在五年內對所有獲獎單位合計投入超過 2.9 億美元,以推進淋巴診斷與治療技術。
LymphaTech was selected as one of seven GLIDE funding recipients and is focusing its research on the development of a new responsive garment using bioimpedance feedback to deliver adaptive compression with Bluetooth-enabled remote monitoring. We believe this program has the potential to extend personalized treatment to millions of diagnosed patients.
LymphaTech 獲選為七家 GLIDE 資助受款者之一,其研究重點為開發一款新的反應式衣物,透過生物阻抗(bioimpedance)回饋來提供自適應加壓,並搭配具藍牙功能的遠端監測。我們相信,該計畫有潛力將個人化治療延伸至數以百萬計的已確診患者。
Along with the first US clinical practice guidelines for lower extremity lymphedema presented in March, which validated PCD therapy, we believe awareness of lymphatic disease and evidence-supported therapies is reaching a historic inflection point for the category.
隨著 3 月發布的美國首份下肢淋巴水腫臨床實務指引(其中驗證了 PCD 治療),我們認為,對淋巴疾病以及具實證支持之療法的認知,正迎來此類別歷史性的拐點。
As an industry leader, Tactile Medical is well-positioned at the center of this momentum, further bolstered by our three ongoing strategic priorities focused on improving access to care, expanding treatment options, and enhancing lifetime patient value. Let me now provide a few updates on each of these.
作為產業領導者,Tactile Medical 具備優勢,能站在這股動能的核心;同時,我們三項持續推進的策略重點——改善照護可近性、擴大治療選項、提升患者終身價值——也進一步強化了我們的定位。接下來我將分別就這三項提供幾點更新。
Beginning with improving access to care, where we are focused on several internal and external-facing initiatives. Internally, we continue to transform each step of the order process with new technology infrastructure and more efficient workflows. AI-enabled technology is playing an increasingly meaningful role in our back-office transformation.
首先是改善照護可近性,我們正聚焦多項內部與對外的倡議。在內部方面,我們持續以新的技術基礎設施與更高效率的工作流程,改造訂單流程的每一個步驟。AI 賦能技術在我們後台轉型中正扮演愈來愈重要的角色。
Over the past several months, we have been leveraging AI capabilities in our order intake processes and parts of our medical record review and have been pleased with both the technology performance and the enhanced workflow efficiencies it's enabling.
在過去幾個月,我們已在訂單受理流程,以及部分病歷審查環節中運用 AI 能力;我們對技術表現與其帶來的工作流程效率提升都感到滿意。
As I shared earlier, this quarter, we successfully accelerated and launched the prior authorization component of our AI platform for Medicare fee-for-service orders ahead of the April 13 deadline.
如我先前所述,本季我們已成功加速並在 4 月 13 日截止日前,提前推出 AI 平台中針對 Medicare 按服務計費(fee-for-service)訂單的事前授權(prior authorization)模組。
Looking ahead, we remain on track to further expand the use of AI capabilities across the entire order process, including patient eligibility and verification of benefits, and full medical record review. With the rollout of these expanded features, we believe we will accelerate speed to therapy, reduce revenue impacting human errors, and improve operational efficiency, each of which should support margin expansion over time.
展望未來,我們仍按計畫進一步擴大 AI 能力在整體訂單流程中的應用,包括患者資格判定與給付福利驗證,以及完整病歷審查。隨著這些擴充功能的上線,我們相信將加速患者進入治療的速度、降低影響營收的人為錯誤,並提升營運效率;上述各項也應可在時間推移下支持毛利率擴張。
Externally, improving market access conditions is supported by clinical evidence generation, guideline dissemination, and engagement with government and commercial payers. For commercial payers, we continue to make steady progress on head and neck coverage and are working to align certain commercial policies to the NCD rather than their current alignment to the retired LCD. As part of that work, our head and neck clinical evidence program continues to advance, with data progressing through the peer-reviewed and publication process.
在外部方面,改善市場准入條件仰賴臨床證據產出、指引推廣,以及與政府與商業保險支付方的互動。就商業支付方而言,我們在頭頸部給付涵蓋方面持續取得穩健進展,並正努力使部分商業保單的對齊基準改為 NCD,而非目前仍對齊已退役的 LCD。作為該項工作的一部分,我們的頭頸部臨床證據計畫持續推進,相關數據正進入同儕審查與發表流程。
Payer engagement is a continued patient advocacy commitment we make for all patients, operationalized through payer education, appealing denials, and activating clinical support with medical directors as needed.
與支付方的互動,是我們對所有患者所做的持續性病患倡議承諾,並透過支付方教育、對拒付提出申訴,以及在需要時與醫療主任啟動臨床支援等方式加以落實。
Next, on expanding treatment options, we are excited to share we recently received FDA 510 clearance for our next-generation AffloVest product. Key enhancements with this next-generation device are focused on improving the patient experience and include further weight reduction, new digital connectivity, and improved size adjustability to allow for a more customized fit.
接著談擴大治療選項。我們很高興分享,近期已取得下一代 AffloVest 產品的 FDA 510(k) 核准(clearance)。此一下一代裝置的主要強化重點在於提升患者體驗,包括進一步減重、新增數位連線功能,以及改善尺寸可調性,以提供更客製化的貼合度。
Additionally, the clearance maintains our indication for use across the full patient age spectrum, from pediatrics through geriatric populations, reinforcing AffloVest's position as a versatile airway clearance solution for bronchiectasis patients at every stage of life. We remain on track for commercial launch this year to ensure the product is available for the 2026 through 2027 winter respiratory season, and we look forward to sharing more updates with respect to timing as we get closer.
此外,此次核准也維持我們在全齡層患者的適應症使用範圍,從兒科到老年族群皆涵蓋在內,進一步鞏固 AffloVest 作為支氣管擴張症患者各生命階段皆適用之多功能氣道清除解決方案的定位。我們仍按計畫於今年進行商業上市,以確保產品可供 2026 至 2027 年冬季呼吸道季節使用;隨著時程更接近,我們也期待分享更多關於時間點的更新。
Our second innovation area is focused on the advanced pump category. As we shared last quarter, our product roadmap includes the introduction of incremental features and product enhancements for Flexitouch focused on the patient experience. These include a new controller, reduced external housing, and remote control functionality through our Kylie Patient Engagement application. We anticipate go-to-market readiness in 2027 for these features.
我們第二個創新領域聚焦於進階幫浦(advanced pump)類別。如同我們上季所分享,我們的產品藍圖包含為 Flexitouch 導入漸進式功能與產品強化,重點同樣在患者體驗。這些強化包括新的控制器、縮小外部機殼,以及透過我們的 Kylie Patient Engagement 應用程式提供遠端控制功能。我們預期這些功能將於 2027 年達到上市(go-to-market)準備就緒。
Beyond these innovation updates, we are also focused on identifying integration points across the combined LymphaTech and Tactile product development portfolios. While it's too early to share specific details of a LymphaTech-integrated product portfolio, we are excited by the expansion of diagnostic and therapy delivery opportunities.
除上述創新更新之外,我們也專注於辨識 LymphaTech 與 Tactile 兩者合併後產品開發組合之間的整合切入點。雖然目前仍言之過早,尚無法分享整合 LymphaTech 的具體產品組合細節,但我們對診斷與治療交付機會的擴大感到振奮。
Finally, our third strategic priority of enhancing the lifetime patient value, which encompasses more efficient and personalized engagement before, during, and after the order and delivery process. As we shared last quarter, we are continuing to focus on targeted care navigation pilots designed to provide clearer guidance to patients earlier in the process and reduce administrative friction.
最後,我們的第三項策略優先事項是提升患者終身價值,涵蓋在下單與交付流程之前、期間及之後,更高效率且更個人化的互動。如同我們在上一季分享的,我們持續聚焦於具針對性的照護導航試點計畫,旨在於流程更早期為患者提供更清晰的指引,並降低行政摩擦。
Results to date continue to support our thesis that patients value clearer communication and guidance earlier in the process. We are refining these pilots to optimize touchpoints, and we are evaluating how to expand their impact in a measured and scalable way. We believe this work will reduce patient leakage, enhance the patient experience, and over time, decrease the need for sales rep involvement in the order process, supporting both growth and operating leverage.
迄今為止的結果持續支持我們的論點:患者重視在流程早期獲得更清楚的溝通與指引。我們正在精進這些試點以最佳化接觸點,並評估如何以審慎且可擴展的方式擴大其影響。我們相信這項工作將降低患者流失、提升患者體驗,並隨時間推移降低訂單流程對銷售代表介入的需求,同時支持成長與營運槓桿。
Taken together, our progress across these strategic priorities reinforces our confidence in the durability of our commercial momentum. Our Q1 results reflect strong execution across both business lines, meaningful progress and agility in our operation transformation initiatives, and the expected return on our go-to-market people technology investments.
綜合而言,我們在這些策略優先事項上的進展,強化了我們對商業動能持久性的信心。我們第一季的成果反映出兩大業務線的強勁執行力、營運轉型計畫的實質進展與敏捷性,以及我們在上市策略(go-to-market)的人才與科技投資所帶來的預期回報。
Intentionality and discipline are key constructs in the way we are operationalizing our strategy, and as a result, the business performance is there. This approach is supported by a strong balance sheet and a thoughtful capital allocation strategy that balances growth investments with shareholder returns.
在我們落實策略的方式上,「有意識的規劃」與「紀律」是關鍵要素,因此業務表現得以展現。此一做法有賴於強健的資產負債表,以及審慎的資本配置策略,在成長投資與股東回報之間取得平衡。
We are confident in the trajectory of our business and the multiple catalysts ahead as we move through 2026 and beyond.
隨著我們邁向 2026 年及更長遠的未來,我們對業務發展軌跡以及前方多項催化因素充滿信心。
With that, I'll now have Elaine review our Q1 financial results in more detail and provide an update on our outlook for 2026.
接下來,我將請 Elaine 更詳細地回顧我們第一季的財務結果,並更新我們對 2026 年的展望。
Elaine Birkemeyer - Chief Financial Officer
Elaine Birkemeyer - Chief Financial Officer
Thanks, Sheri. Unless noted otherwise, all references to first-quarter financial results are on a GAAP and year-over-year basis.
謝謝你,Sheri。除非另有說明,所有對第一季財務結果的提及皆以 GAAP 及年對年為基礎。
Total revenue in the first quarter increased by $14 million or 23% to $75.3 million. Our product line sales and rentals of lymphedema products, which includes our Flexitouch, Entre, Nimbl, and LymphaTech systems, increased $11.7 million or 23% to $62.2 million. And sales of our airway clearance products, which includes our AffloVest system, increased $2.3 million or 22% to $13 million.
第一季總營收增加 1,400 萬美元(年增 23%),達 7,530 萬美元。我們淋巴水腫產品線(包含 Flexitouch、Entre、Nimbl 與 LymphaTech 系統)的銷售與租賃收入增加 1,170 萬美元(年增 23%),達 6,220 萬美元。而我們氣道清除產品(包含 AffloVest 系統)的銷售增加 230 萬美元(年增 22%),達 1,300 萬美元。
Growth was broad-based and reflected strength across both volume and revenue per unit, including higher shipments, strong collections, and a favorable mix across payer and product categories.
成長動能廣泛,反映出出貨量與單位收入(revenue per unit)雙雙走強,包括出貨量提升、回款表現強勁,以及付款方與產品類別組合有利。
Continuing down the P&L. Gross margin was 76.5% of revenue compared to 74% in the first quarter of 2025. The increase in gross margin was attributable primarily to lower manufacturing costs, stronger collections, and favorable product and payer mix reflected in our revenue. Importantly, these improvements reflect structural enhancements in the business rather than temporary cost actions.
接著看損益表。毛利率為營收的 76.5%,相較於 2025 年第一季的 74%。毛利率提升主要歸因於較低的製造成本、更強勁的回款,以及反映在營收中的有利產品與付款方組合。重要的是,這些改善反映的是業務結構性的提升,而非暫時性的成本措施。
First-quarter operating expenses increased $9.3 million or 19% to $59.1 million. The change in GAAP operating expenses reflected a $5.2 million increase in sales and marketing expenses, a $1 million increase in research and development expenses, and a $3 million increase in reimbursement general and administrative expenses.
第一季營業費用增加 930 萬美元(年增 19%),至 5,910 萬美元。GAAP 營業費用的變動反映:銷售與行銷費用增加 520 萬美元、研發費用增加 100 萬美元,以及報銷相關的一般與行政費用增加 300 萬美元。
As we discussed previously, we are annualizing investments made in 2025, while continuing to invest in IT infrastructure and automation to support long-term growth. Despite these ongoing investments, operating loss decreased $3 million to 66% to $1.5 million.
如先前所述,我們正在把 2025 年的投資年化,同時持續投資於 IT 基礎設施與自動化,以支持長期成長。儘管持續投資,營業損失仍減少 300 萬美元(降幅 66%),至 150 萬美元。
Interest income decreased $0.2 million or 26% to $0.7 million due to our decreased cash position. Interest expense decreased $0.4 million or 93% to $28,000.
由於現金部位下降,利息收入減少 20 萬美元(年減 26%),至 70 萬美元。利息費用減少 40 萬美元(年減 93%),至 2.8 萬美元。
Income tax expense was $0.9 million compared to an income tax benefit of $1.1 million. Net loss decrease to $1.2 million or 41% to $1.8 million or $0.08 per diluted share compared to $3 million or $0.13 per diluted share.
所得稅費用為 90 萬美元,相較之下去年同期為 110 萬美元的所得稅利益。淨損減少 120 萬美元(降幅 41%),至 180 萬美元,或稀釋後每股 0.08 美元;相較去年同期為 300 萬美元,或稀釋後每股 0.13 美元。
Adjusted EBITDA increased to $3.7 million compared to an adjusted EBITDA loss of $0.3 million in the prior year, with margin expanding to 4.9% from negative 0.4%, reflecting a meaningful improvement in operating leverage.
調整後 EBITDA 增至 370 萬美元,相較去年同期調整後 EBITDA 為虧損 30 萬美元;利潤率由負 0.4% 擴大至 4.9%,反映營運槓桿的顯著改善。
With respect to our balance sheet, we had $75 million in cash and cash equivalents and no outstanding borrowings at quarter end. This compares to $83.4 million in cash and no outstanding borrowings as of December 31, 2025. The change in cash during the quarter primarily reflects the LymphaTech acquisition, share repurchases, and normal seasonal items such as bonus payments. We continue to see improvement in working capital efficiency, including a meaningful reduction in days sales outstanding.
就資產負債表而言,季末我們持有 7,500 萬美元的現金及約當現金,且無任何未償借款。相較於 2025 年 12 月 31 日,我們持有 8,340 萬美元現金且同樣無未償借款。本季現金變動主要反映 LymphaTech 併購、庫藏股回購,以及獎金支付等正常季節性項目。我們持續看到營運資金效率改善,包括應收帳款週轉天數(DSO)的顯著下降。
Turning to review of our 2026 outlook. For the full year of 2026, we are raising our guidance and now expect total revenue in the range of $360 million to $368 million, representing growth of approximately 9% to 12% year over year. This guidance assumes both our lymphedema and airway clearance businesses will grow in a similar overall range with airway growing modestly faster.
接著回顧我們對 2026 年的展望。針對 2026 全年,我們上調指引,現預期總營收介於 3.60 億至 3.68 億美元,年增約 9% 至 12%。此指引假設淋巴水腫與氣道清除兩項業務的整體成長區間相近,其中氣道清除成長略快。
The increase in guidance is driven by three primary factors. First, we continue to expect strength in the commercial execution across the business. Second, we have included the contribution from LymphaTech. Third, we have incremental early confidence in how the MACs are navigating the new prior authorization requirements we discussed on our last call.
指引上調主要由三項因素驅動。第一,我們仍預期全公司商業執行力將維持強勁。第二,我們已納入 LymphaTech 的貢獻。第三,對於我們在上次電話會議中提到的新事前授權(prior authorization)要求,MACs 的因應與運作方式,我們在早期已獲得額外信心。
More broadly, we believe underlying demand remains durable, and our tools and processes designed to support prior authorizations are tracking well against plans. While prior authorization approval data is still early and continuing to take shape, our outlook appropriately reflects discipline until we have a longer track record of consistent outcomes.
更廣泛而言,我們認為基礎需求仍具韌性,而我們為支持事前授權所設計的工具與流程,正按計畫推進。雖然事前授權核准數據仍屬早期且仍在成形中,我們的展望在取得更長期且一致的結果紀錄之前,仍適度反映審慎與紀律。
For modeling purposes for the full year 2026, we expect our GAAP gross margins to be 76% to 77%, our GAAP operating expenses to increase 10% to 12% year over year, the increase relative to our prior outlook reflects one-time acquisition and legal-related costs, net interest income of approximately $3 million, a tax rate of 28%, and a fully diluted weighted average share count of approximately 22 million to 23 million shares.
就 2026 全年建模而言,我們預期 GAAP 毛利率為 76% 至 77%,GAAP 營業費用年增 10% 至 12%;相較先前展望的增幅,反映一次性的併購與法律相關成本;淨利息收入約 300 萬美元;稅率 28%;以及完全稀釋加權平均股數約 2,200 萬至 2,300 萬股。
We continue to expect to generate adjusted EBITDA of approximately $49 million to $51 million in 2026. This outlook reflects the annualization of 2025 investments and continued strategic investments in 2026, which we believe are important to support long-term and operating leverage.
我們仍預期 2026 年可產生約 4,900 萬至 5,100 萬美元的調整後 EBITDA。此展望反映 2025 年投資的年化,以及 2026 年持續的策略性投資;我們相信這些投資對於支持長期成長與營運槓桿至關重要。
Our adjusted EBITDA expectation assumes certain non-cash items, including a stock compensation expense of approximately $9 million, intangible amortization of approximately $3.6 million, depreciation expense of approximately $3.2 million, litigation-related expenses of approximately $1 million, and one-time acquisition-related and integration cost of $1.3 million.
我們的調整後 EBITDA 預期包含若干非現金項目,包括:約 900 萬美元的股票薪酬費用、約 360 萬美元的無形資產攤銷、約 320 萬美元的折舊費用、約 100 萬美元的訴訟相關費用,以及 130 萬美元的一次性併購相關與整合成本。
With that, I'll turn the call back to Sheri for the closing remarks. Sheri?
接下來,我把電話會議交回 Sheri 做結語。Sheri?
Sheri Dodd - Chief Executive Officer, Director
Sheri Dodd - Chief Executive Officer, Director
Thank you, Elaine. We are encouraged by a strong balanced start to the year and the trajectory of our business. Our Q1 results demonstrated broad-based performance and reflect disciplined execution, improving productivity from a fully built commercial organization and the increasing benefits from investments we have made in technology and infrastructure.
謝謝你,Elaine。我們對今年強勁且均衡的開局以及業務發展軌跡感到振奮。我們第一季的結果展現廣泛的表現,並反映出紀律性的執行、完整建置的商業組織所帶來的生產力提升,以及我們在科技與基礎設施投資所帶來的效益日益顯現。
As we look ahead, our focus remains on the fundamentals that matter most: expanding access to care, innovating across our product portfolio, and enhancing lifetime patient value. While we remain mindful of near-term adjustments related to Medicare prior authorization, ultimately, we believe this change reinforces our emphasis on clinical rigor, access durability, and long-term reimbursement stability, and we are well-positioned to navigate it.
展望未來,我們的重點仍聚焦於最重要的基本面:擴大照護可近性、在產品組合上持續創新,以及提升患者終身價值。儘管我們仍留意與 Medicare 事前授權相關的短期調整,但我們最終相信這項變更強化了我們對臨床嚴謹性、可近性的持久性與長期報銷穩定性的重視,而我們也已做好充分準備加以因應。
We are operating from a position of strength, supported by a resilient balance sheet, multiple growth levers in motion, and a clear strategy to translate consistent execution into sustained growth over time.
我們正以強勁的態勢營運,背後有具韌性的資產負債表支撐、多項成長動能同步推進,並且有清晰的策略,將一貫的執行力轉化為長期且可持續的成長。
With that, operator, we'll now open the call for questions.
接下來,接線員,我們現在開放提問。
Operator
Operator
(Operator Instructions) Ryan Zimmerman, BTIG.
(接線員指示)Ryan Zimmerman,BTIG。
Ryan Zimmerman - Analyst
Ryan Zimmerman - Analyst
Good afternoon, and congrats on a nice start to the year here. I want to ask about some of the dynamics that are starting to occur in second quarter.
各位下午好,也恭喜今年開局表現不錯。我想請教一些第二季開始出現的動態。
Sheri, I think you called out some pull-forward dynamic with lymphedema sales ahead of 2Q. And so one, I think if I look at the beat versus kind of where you're raising guidance came in, there's about a $1.7 million difference there. I just want to understand if that was the pull-forward effect.
Sheri,我想你提到在第二季之前,淋巴水腫(lymphedema)銷售有一些提前發生的動態。所以第一點,如果我看實際優於預期(beat)相較於你們上調財測(guidance)的幅度,兩者之間大約有 170 萬美元的差異。我想了解那是否就是提前發生的影響。
And then just anecdotally, kind of what you're seeing with the MAC in 2Q, how they're responding to this, how physicians are responding to this. And the cadence of sales, we should think about, I apologize, there's a lot here, but the cadence sales we should think about over the balance of the year because you've historically seen kind of 1Q step up or -- excuse me, 2Q step up from 1Q. So is there a bit of a pause or dynamic in the market we need to think about for 2Q? Sorry for the multi-part question there.
另外,就你們在第二季看到的 MAC(Medicare Administrative Contractor,醫療保險行政承包商)反應、他們如何回應這件事、醫師如何回應,以及銷售節奏方面的觀察。不好意思,問題有點多,但我們應該如何看待今年剩餘期間的銷售節奏?因為你們過去通常會看到第一季到第二季有一個上台階——呃,抱歉,是第二季相較第一季上台階。所以第二季是否會有一些暫停或市場動態需要我們納入考量?抱歉這是個多段式問題。
Sheri Dodd - Chief Executive Officer, Director
Sheri Dodd - Chief Executive Officer, Director
No, that's okay. Let's take it kind of layer by layer here. So what I'll first say is I want to kind of reorient this kind of concept of a pull forward because it wasn't really a pull forward.
不會,沒關係。我們一層一層來看。首先我想先重新釐清「提前拉貨(pull forward)」這個概念,因為它其實不太算是提前拉貨。
What we did is we had patients that their orders were in process, initially, they were not all the way completed by that date. They would have been exposed to an overall denial. And so what we did is a little bit of an acceleration of that, but not necessarily stealing orders, if you will, from Q2 and shipments from Q2 into Q1.
我們做的是:有些病患的訂單正在處理中,一開始在那個日期之前並沒有全部完成;如果照原本進度,他們可能會面臨整體性的拒付(denial)。因此我們做的是稍微加速流程,但不一定是把第二季的訂單或第二季的出貨「挪」到第一季。
So I wouldn't characterize it necessarily as a pull forward. But what we have been doing and what we have been seeing truly is great on our side in terms of our systems and our processes are working really pleased. We accelerated what we were going to do next year and got it all in place by that go-live date. So very pleased with that.
所以我不會把它定義為提前拉貨。不過我們一直在做、也確實看到的是:就我們這邊而言非常好,代表我們的系統與流程運作順暢,我們也很滿意。我們把原本預計明年才要做的事情提前加速,並在上線(go-live)日期前全部到位,所以對此非常滿意。
So what you're seeing in terms of our positioning on the prior authorization doesn't have anything to do with our readiness. It really has to do with some early variability. We're seeing within the MACs. And again, Ryan, we're only three weeks into this entire process. So it's still new.
因此,你看到我們在事前授權(prior authorization)上的布局,與我們的準備度無關;主要是因為我們在 MAC 之間看到一些早期的差異性。而且 Ryan,我們才進入整個流程的第三週,所以一切都還很新。
Orders are flowing through. We're seeing what those denial and approval rates are, but we are seeing some difference between the MACs. And so, there shouldn't be variability between the MACs.
訂單正在流轉,我們也在觀察拒付與核准(approval)比率,但確實看到不同 MAC 之間存在差異。而理論上,MAC 之間不應該有差異。
If you are in one state and you're a Medicare patient and you have the exact same criteria, you shouldn't be denied based on where you live. And so we're seeing a little bit of variability. This is not uncommon because MACs are trying to make sure their interpretation is the same, that their -- how the data and information is rolling through on their side, training and education.
如果你在某個州、你是 Medicare 病患、且符合完全相同的條件,就不應該因為居住地不同而被拒付。所以我們看到一些差異性。這並不罕見,因為 MAC 需要確保他們的解讀一致、他們那端資料與資訊的流轉方式一致,以及訓練與教育到位。
So everything we're seeing, we don't think is anything other than administrative. And we're going to have an opportunity of talking to the MACs about this. We also don't see any of this as being longstanding. We believe we're going to be able to adjust. And with more experience in the prior authorization, we believe that our confidence in what that true process time is, as well as those approval rates, we'll have a lot more confidence.
所以我們看到的一切,我們認為除了行政面因素之外沒有其他原因。我們也會有機會與 MAC 討論這些狀況。我們也不認為這會是長期問題;我們相信可以調整。隨著事前授權經驗累積,我們對於實際流程所需時間以及核准率會更有把握,信心也會更高。
So from a guidance standpoint, we did pull through what would be the LymphaTech revenue went into there, as well as some of our overall business deliver confidence. And then we are going to hold a little bit until we have a few more weeks.
就財測(guidance)而言,我們把原本會實現的 LymphaTech 營收納入其中,同時也反映我們對整體業務交付的信心。接下來我們會先稍微保守一點,等再多幾週的數據。
It's not going to be the full year. Until we start to see what that prior auth process looks like, again, more from the MAC side than on our side.
不會等到全年結束;我們會等到開始更清楚看到事前授權流程的樣貌——再次強調,更多是從 MAC 端,而不是我們這邊。
I think I answered majority of your questions, but anything that I forgot, or Elaine, do you want to weigh in on anything?
我想我回答了你大部分的問題,但如果我有漏掉什麼,或 Elaine 你想補充嗎?
Ryan Zimmerman - Analyst
Ryan Zimmerman - Analyst
You did a great job.
你回答得很好。
Elaine Birkemeyer - Chief Financial Officer
Elaine Birkemeyer - Chief Financial Officer
Yeah, I think, Ryan, you had a question a little bit on sequencing and kind of Q2 to Q3. So we do continue to expect to see growth in Q2 or Q2 unlike we always have. I will say kind of the Q2, Q3 this year will look a little bit different. I think together, those two quarters will be the same, but I would say we'll see a little bit of a lighter step up in Q2 than some of the years past and probably a bigger step up in Q3 as it starts to normalize just as that went into effect. It just created a little bit of a delay as that prior off, we had to wait for those responses and for the whole new process to get going. So I would say collectively, those two quarters are going to be the same, but there'll be a little bit of a difference between the two.
對,我想 Ryan 你也問到一些關於時序安排,像是第二季到第三季的節奏。我們仍然預期第二季會成長,第二季也會像以往一樣。我會說今年第二季、第三季看起來會有點不同:合在一起看,這兩季的表現會相同,但第二季的上台階幅度會比過去幾年稍微小一些,而第三季可能會有更大的上台階,因為隨著新規生效後逐步回到常態。這只是造成了一點延遲,因為事前授權(prior auth)需要等待回覆,整個新流程也需要啟動時間。所以我會說合計來看這兩季會一樣,但兩季之間會有些差異。
Ryan Zimmerman - Analyst
Ryan Zimmerman - Analyst
Okay, very helpful. And then I'm going to sneak one more, and I'll get back in queue because I probably have asked too many now. But just on the LymphaTech contribution, so I appreciate you guys calling that out. When do you expect that to be meaningful in the year, number one, so how should we think about when it really starts to contribute?
好的,很有幫助。那我再偷偷問一個,然後我會回到排隊,因為我可能問太多了。關於 LymphaTech 的貢獻:謝謝你們特別提到。第一,你們預期它在今年什麼時候會變得有意義?我們應該如何看待它何時真正開始貢獻?
And then two, as we think about kind of what it can do over time, how are you thinking about what LymphaTech can offer in terms of a contribution to the business as we look out further into '27 and beyond? Thanks for taking the question.
第二,從長期來看,它能做什麼?你們如何看待 LymphaTech 對業務的貢獻潛力,尤其是展望到 2027 年及之後?謝謝讓我提問。
Sheri Dodd - Chief Executive Officer, Director
Sheri Dodd - Chief Executive Officer, Director
Yeah. You bet. So on the LymphaTech , so the grants that we discussed, super excited about the LIGHT and the GUIDE grants, that actually comes through as revenue, which is why now it's in the overall guidance that we put forward.
好的,沒問題。關於 LymphaTech,我們提到的補助(grants),我們對 LIGHT 與 GUIDE 兩項補助非常興奮;那其實會以營收形式入帳,這也是為什麼現在它被納入我們提出的整體財測(guidance)之中。
But prior to that, when we did our original guidance, we did not see any real growth happening from LymphaTech or any big contributions. So what you're seeing now is really a result of the grants coming through as revenue.
但在此之前,當我們最初提出財測時,我們並沒有預期 LymphaTech 會帶來任何實質成長或重大貢獻。所以你現在看到的,主要是補助以營收形式入帳所帶來的結果。
Where we're most excited about LymphaTech is not going to transpire this year. I mean, we did the acquisition on multiple fronts. But that ability of the R&D capabilities that LymphaTech brings will be a big part of how we're thinking about our go-forward, not just as a Flexitouch next gen, but if you think about therapy in general.
我們對 LymphaTech 最興奮的部分不會在今年發生。我的意思是,我們進行這項收購有多個面向;但 LymphaTech 帶來的研發(R&D)能力,將會是我們思考未來布局的重要一環,不僅是 Flexitouch 下一代產品(next gen),如果你從整體治療(therapy)的角度來看也是如此。
And when you kind of see the details, and as I describe the details of that guide, actually looking at garments that are using bioimpedance and delivering on a personalized care, we're very excited about that. Just can't share any timelines on when -- what that R&D portfolio looks like right now, but we'll be able to share that much more in the quarters to come as that gets further defined in our overall strategy for therapy delivery.
當你看到細節、以及我描述 GUIDE 的細節時——它其實是在看使用生物電阻抗(bioimpedance)的衣物(garments),並提供個人化照護(personalized care)——我們對此非常期待。只是目前還不能分享任何時間表,也就是現在研發產品組合(R&D portfolio)長什麼樣子;但在接下來幾個季度,隨著它在我們整體治療交付策略中被更明確定義,我們會分享更多。
On the diagnostic side, one of the big drivers we -- from LymphaTech is actually getting the FDA approval for more of that diagnostic indication and then getting through the CPT codes that actually enable a payment for the diagnostic. So that is going to take a little bit of time. But on the here and now, super excited to have the federal funded government grants helping support the R&D efforts that we know are going to fit directly into our future portfolio.
在診斷(diagnostic)方面,LymphaTech 的一個重要驅動因素,是取得更多診斷適應症(diagnostic indication)的 FDA 核准,並推進 CPT 代碼(CPT codes),以便真正讓診斷能夠獲得給付(payment)。這會需要一些時間。但就眼前而言,我們非常高興能有聯邦政府資助的補助來支持研發投入,而我們也知道這些研發成果將會直接納入我們未來的產品組合。
Ryan Zimmerman - Analyst
Ryan Zimmerman - Analyst
Thank you.
謝謝。
Sheri Dodd - Chief Executive Officer, Director
Sheri Dodd - Chief Executive Officer, Director
Ryan, the last thing I say, you had a great question, but I kind of want to bookend it about, the guidance and the flow-through. And it's a great question, but our approach to how we're thinking about it, again, we said it's only three weeks in, but we saw and we held on the NCD when it converted from the LCD to the NCD because we knew there were going to be changes in interpretation and time needed to get progressing before we felt super confident about what we could do to lean into that.
Ryan,我最後想說的是,你問了一個很好的問題,但我想把它前後呼應一下,聚焦在指引(guidance)與流量轉換(flow-through)上。這確實是個好問題;而我們在思考這件事的做法是——再次強調,我們才剛過三週——但我們在 NCD 從 LCD 轉為 NCD 時選擇按兵不動、先觀望,因為我們知道解釋上會有變動,也需要一些時間讓流程推進,等到我們對於可以如何更積極投入(lean into)這件事有十足把握。
And so everything we're doing now is really based on precedent and what we've done before, and it worked well. And we're super confident that this administrative pieces in this early days of the prior auth will flow through and we're in the best position to handle it. So it's a real thing, but we don't sit here with a lot of concern. We just want more time to be able to fully articulate what that benefit will be.
因此,我們現在所做的一切其實都是基於先例與我們過去做過、且效果良好的做法。我們非常有信心,在事前授權(prior auth)初期這些行政面的事項會逐步反映出來(flow through),而我們也處於最佳位置來應對。這確實是真實存在的議題,但我們並沒有太多擔憂;我們只是希望有更多時間,才能把這項效益會帶來什麼更完整地表述清楚。
So the question you didn't ask, but I wanted kind of bookend it based on the questions that you did ask.
所以這是你沒有問、但我想根據你剛才問的問題,做個前後呼應的補充。
Ryan Zimmerman - Analyst
Ryan Zimmerman - Analyst
Thank you.
謝謝。
Operator
Operator
Brandon Vasquez, William Blair.
Brandon Vasquez,William Blair。
Brandon Vazquez - Analyst
Brandon Vazquez - Analyst
Hey, everyone. Thanks for taking the question, and congrats on a nice quarter. I hate to do this, but can we stick for a second on this concept of the pull-forward versus accelerated? I'm not sure I fully understand it, and I want to make sure it's clear, because I think it'll be important to understand kind of one, the strength in the quarter; and two, the sequential changes from here. So maybe just spend a second specifically on the nuances between why a pull-forward isn't -- or sorry, why accelerated sales isn't necessarily a pull-forward of sales from Q2.
各位好。謝謝讓我提問,也恭喜本季表現不錯。我不太想一直追問這個,但能不能再花一點時間談談「拉貨(pull-forward)」相對於「加速(accelerated)」這個概念?我不確定我是否完全理解,我想確認它很清楚,因為我認為這對理解:第一,本季的強勁表現;第二,接下來的逐季變化,會很重要。所以也許請具體說明一下其中的細微差異:為什麼「加速銷售」不一定等同於把原本 Q2 的銷售「拉」到 Q1(pull-forward)?
Sheri Dodd - Chief Executive Officer, Director
Sheri Dodd - Chief Executive Officer, Director
Yes. So we did the order acceleration for patient benefit, not to cover revenue. I would say that typically a pull-forward is because you're trying to cover revenue. You're trying to accelerate what you would have received in revenue in the next quarter, and you try to bring it into this quarter.
好的。我們做訂單加速(order acceleration)是為了病患利益,而不是為了補營收。我會說,一般所謂的拉貨(pull-forward)通常是因為你想補營收——你想把原本下個季度會認列的營收加速到本季度來。
When we talk about order acceleration, we really did this for the patient benefit. So, i.e., those patients that had an order in process, if they didn't clear the order by that April 13 date, it would have had to go all the way back and be resubmitted into a prior auth. So we had some orders. This is not a material amount. We had some orders that were going to fall on that kind of magic date of April 13. So we put extra resources to help make sure that that order went through, but we weren't taking an order from Q2 in order to book the revenue into Q1.
但我們談的訂單加速,確實是為了病患利益。也就是說,那些正在處理中的訂單,如果沒有在 4 月 13 日那個日期前完成,就必須全部退回並重新提交,進入事前授權(prior auth)流程。我們有一些訂單——金額並不重大——會落在 4 月 13 日這個「關鍵日期」附近。因此我們投入額外資源,確保這些訂單能順利通過;但我們並不是把 Q2 的訂單提前到 Q1 來認列營收。
Brandon Vazquez - Analyst
Brandon Vazquez - Analyst
Okay, got it. That's clear. Thank you. Maybe follow-up here, a little bit of a broader picture. There's a lot of commercial investments you guys have that have gone through 2025 and are ramping into this year. Maybe help characterize where some of these are in terms of maturing. Should the benefits still be growing? Are we kind of reaching maturity for some of them, like the commercial team, things like that? So maybe just talk to us about what inning we are in some of these real more meaningful commercial investments. Thanks.
了解,這樣就清楚了,謝謝。接著我想追問一個更宏觀的問題。你們有不少商業化投資在 2025 年一路推進,並在今年持續爬坡。能否協助描述一下其中一些投資目前成熟到什麼程度?效益是否仍會持續成長?還是像商業團隊之類的部分已接近成熟期?所以想請你們談談,這些更具意義的商業化投資目前大概進行到第幾局(inning)了。謝謝。
Sheri Dodd - Chief Executive Officer, Director
Sheri Dodd - Chief Executive Officer, Director
Yeah, certainly. So we're really pleased at where we sit right now in terms of our headcount. And as I stated in the prepared remarks, we're moving from capacity building and onboarding to true productivity. And so we now feel that we're at a place where we have fully resourced sales organization on that one-to-one ratio of our territory managers to our account specialists, so we feel in a really good place.
當然可以。我們對目前的人力配置位置非常滿意。正如我在事先準備的發言中提到的,我們正從「擴充產能與新人到位(onboarding)」轉向真正的「生產力提升」。因此我們現在覺得,我們已經建立起完整配置的銷售組織,在區域經理(territory managers)與客戶專員(account specialists)之間達到一對一的配置比例,所以我們覺得狀態很好。
As far as our CRM tool, our reps are continuing to use that tool, including workflow tools that really help support their activity. And that is also going very well, and we expect that revenue per rep year-on-year growth to turn positive as we progress throughout the year.
至於我們的 CRM 工具,業務代表持續使用該工具,包括能實際支援其活動的工作流程工具(workflow tools)。這方面進展也很順利;我們預期隨著今年推進,每位業務的人均營收(revenue per rep)年對年成長將轉為正成長。
So I think net-net, we're certainly transitioning from what was build and bring the tool to actually having a fully resourced field organization that productivity is stepping up and continues to step up. And so we are seeing that increase in overall referrals per rep and feel in a really good place with that.
所以整體而言,我們確實正從「建置並導入工具」的階段,轉向「外勤組織已完整到位、且生產力正在提升並持續提升」的階段。我們也看到每位業務的整體轉介量(referrals per rep)增加,對此我們感到非常有信心。
Operator
Operator
(Operator Instructions) Adam Maeder, Piper Sandler.
(接線員指示)Adam Maeder,Piper Sandler。
Unidentified Participant
Unidentified Participant
Yeah. Hi, this is Kyle on for Adam. Thanks for taking the questions, and congrats on a good start to the year.
你好,我是 Kyle,代 Adam 提問。謝謝讓我提問,也恭喜今年開局不錯。
Maybe I'll ask on the EBITDA guidance. The Q1 results beat expectations and then you raised revenue guidance. So just trying to kind of help understand or maybe you could help us unpack keeping the EBITDA guidance kind of where it is.
我想問一下 EBITDA 指引(guidance)。Q1 結果優於預期,且你們也上調了營收指引。所以我想了解一下,為什麼 EBITDA 指引仍大致維持原先水準;也許你們可以幫我們拆解一下。
I know you mentioned some of the acquisition costs and some of the one-time expenses there. And I noticed the uplift in OpEx spend for the year. So is that -- should we just understand a lot of that as kind of part of this acquisition or is it more of this robust R&D pipeline? Can you just help us a little bit there?
我知道你們提到一些併購成本與一次性費用。我也注意到今年營業費用(OpEx)支出上調。所以我們是否應該把其中很大一部分理解為併購相關?還是更多是因為強勁的研發(R&D)管線?能否請你們多說明一下?
Elaine Birkemeyer - Chief Financial Officer
Elaine Birkemeyer - Chief Financial Officer
Yeah. In terms of that, I think there's probably two factors. I think one is a portion of the increases due to LymphaTech, as Sheri mentioned. That is really related to the grant work we're doing, where it's really service-based work that is on that lower margin side. Again, this is not the broader business model, but it happens to be in our revenue this year. And so that's one of the reasons why.
好的。就這點而言,我認為大概有兩個因素。第一,部分增加來自 LymphaTech,如 Sheri 所提。這主要與我們正在進行的補助金(grant)工作有關,那基本上是以服務為主的工作,毛利率相對較低。再次強調,這不是我們更廣泛的商業模式,但它剛好會反映在我們今年的營收中;這是原因之一。
And then secondarily, as you said, we did have some in-period one-time cost and as far as in our OpEx as well. But I would say that the biggest driver of that is really just the type of revenue lift that is coming from with the tech and just the nature of that revenue.
第二,如你所說,我們在本期也確實有一些一次性成本,包含在營業費用(OpEx)中。但我會說,最大的驅動因素其實是來自該技術相關的營收增量類型,以及那類營收本身的特性。
Unidentified Participant
Unidentified Participant
Okay, got it. That's helpful. And then congrats on the clearance for the next-gen AffloVest. I know that was exciting to get through. So just wanted to ask on that specifically, it sounds like you will be able to have this launched for this winter season, as you discussed. So just curious how we should think about that in terms of the growth with that product, with the next-gen system, with the advanced features. And then is there very much of that baked into the guidance for the full year, maybe just a little bit towards the end of the year, or is it kind of just an upside lever at this point?
了解,這很有幫助。另外也恭喜下一代 AffloVest 獲得核准,我知道那很令人振奮。我想就此具體請教:聽起來你們如先前所說,能在今年冬季呼吸道季節前推出。那我們應該如何看待這項產品(下一代系統、進階功能)對成長的影響?另外,全年指引中是否已納入相當程度的貢獻——也許只在年底稍微反映——還是說目前它更像是一個上行選項(upside lever)?
Sheri Dodd - Chief Executive Officer, Director
Sheri Dodd - Chief Executive Officer, Director
Yes, thanks for the question. And we're super excited to have gotten the FDA approval for this product and really excited to have these features that are going to help drive that patient experience.
是的,謝謝你的問題。我們對這項產品取得 FDA 核准感到非常興奮,也很期待這些功能能幫助提升病患體驗。
Just as a reminder, so the reimbursement, the payment is exactly the same for our current generation as well as the AffloVest 6 generation. So there's no additional reimbursement that's in place for that. And it definitely will be available, and we're currently going to be working with our DMEs on the timing of that to make sure that they pull down the inventory that they currently have on the Gen 5 and that the training and education is all done in time for that respiratory season at the end of this year and will come into the end of next year.
提醒一下,在給付方面,無論是我們現行世代產品或 AffloVest 第 6 代,報銷/給付金額完全相同;因此並沒有針對它額外增加的報銷。它確實會上市,而我們目前會與 DME(耐用醫療設備供應商)合作確認時程,確保他們先把現有第 5 代(Gen 5)的庫存出清,同時在今年底的呼吸道季節前完成所有訓練與教育,並延續到明年年底。
From an overall guidance standpoint, our guidance assumes both lymphedema and airway clearance are going to grow in a similar overall range, with airway clearance growing slightly faster. And so that's already been built into our guide. We anticipated to have the product this year. And again, with no incremental dollars out there on the reimbursement, it simply is a better patient experience and we'll continue to drive penetration and adoption within our DMEs.
就整體指引而言,我們的指引假設淋巴水腫(lymphedema)與氣道清除(airway clearance)都會在相近的區間成長,其中氣道清除會略快一些;這已經反映在我們的指引中。我們原本就預期今年會有這項產品。再者,由於報銷端沒有額外增量金額,它本質上就是帶來更好的病患體驗,我們也將持續推動在 DME 端的滲透與採用。
Unidentified Participant
Unidentified Participant
That's great. Thank you, guys.
太好了。謝謝各位。
Operator
Operator
Ben Haynor, Lake Street Capital.
Ben Haynor,Lake Street Capital。
Benjamin Haynor - Analyst
Benjamin Haynor - Analyst
Good afternoon. Thanks for taking the questions. First off for me, I'm wondering on the guidelines for lower limb, any more color you can kind of share there on what the initial reaction has been from clinicians? And then just maybe some commentary overall on mix of the lymphedema market is 52% of cases lower limb. Any color you can provide for investors there would be helpful.
下午好。感謝接受提問。首先我想請教關於下肢的臨床指引,您能否再多分享一些臨床醫師的初步反應?另外,整體來看,淋巴水腫市場的病例中有 52% 是下肢。若能就此提供一些資訊給投資人,將非常有幫助。
Sheri Dodd - Chief Executive Officer, Director
Sheri Dodd - Chief Executive Officer, Director
Sure. On the guideline standpoint, we're really pleased to have the guidelines presented at AVS in February, and it is anticipated that those guidelines will be published this summer.
當然。就指引方面而言,我們很高興這些指引已於 2 月在 AVS 上發表,並預期將於今年夏天正式刊登發表。
So as always, Ben, it's great to have the guidelines in terms of the dissemination of the guidelines down and training clinicians. That's something that our teams are going to be prepared for and help with the overall education about that.
所以一如既往,Ben,有了指引之後,接下來就是把指引向下傳播並訓練臨床醫師。這是我們團隊會做好準備並協助推動的,也會在整體教育上提供支持。
And what we're really pleased about the guidelines is they specifically called out pneumatic compression devices as being part of guideline-based care, which is differentiating from non-PCD products. So excited to have us positioned well within the overall evidence-based care guidelines, and we'll roll that out and help communicate that, yeah.
而我們對這些指引特別滿意的一點是,它們明確指出氣動加壓裝置(pneumatic compression devices)屬於依循指引的照護的一部分,這也使其與非 PCD 產品有所區隔。因此我們很期待能在整體循證照護指引中占據有利位置;我們也會推動落地並協助對外溝通,是的。
Elaine Birkemeyer - Chief Financial Officer
Elaine Birkemeyer - Chief Financial Officer
Yeah, and then in terms of kind of mix of kind of what is lower versus upper extremity, I think the best way to think about this is really what causes lymphedema for patients. So we've said about a third of patients get lymphedema due to cancer, while the remainder are different -- other different causes, with a big one being CDI.
是的,至於下肢與上肢的占比,我認為最好的理解方式是回到:患者的淋巴水腫是由什麼原因造成的。我們曾提到,大約三分之一的患者是因癌症而罹患淋巴水腫,其餘則是其他不同原因,其中一個很大的原因是 CDI。
The cancer often can be upper body. If you think about breast cancer, head and neck cancer, there could still be some lower extremities, with any type of pelvic cancer, but that's where you tend to see the upper extremity where the other drivers, typically CVI, happen to be lower extremities.
癌症往往可能發生在上半身。以乳癌、頭頸癌來看,確實也可能出現下肢(例如任何骨盆腔癌症),但通常你會看到上肢;而其他驅動因素,通常是 CVI,則多發生在下肢。
So that probably gives you a little bit of a sense of that, but it really has to do with what is the underlying cause or driver, which is what causes where the area of lymphedema is in the body.
所以這大概能讓你對此有一些概念;但本質上還是取決於其根本原因或驅動因素,而這也決定了淋巴水腫在身體的哪個部位出現。
Benjamin Haynor - Analyst
Benjamin Haynor - Analyst
That's definitely helpful. And would you expect additional clinical guidelines to be forthcoming for upper extremities, upper areas of the body?
這確實很有幫助。那您是否預期未來也會針對上肢、或身體上半部位,推出更多臨床指引?
Sheri Dodd - Chief Executive Officer, Director
Sheri Dodd - Chief Executive Officer, Director
There certainly is, as Elaine said, that that's largely in the oncology area. So there are definitely some white papers positioned in this area, and so that could definitely transpire.
確實有可能。正如 Elaine 所說,這主要是在腫瘤科領域。因此在這個領域確實已有一些白皮書的布局,所以確實可能會發生。
I'm not aware of anything specifically that's in the work on the upper extremity side, but we're really pleased at how well-positioned and the adoption of pneumatic compression therapy in upper extremity patients, particularly with therapists and oncology is not -- it's well understood, if you will, where lymphedema in the lower extremity, it's almost a process of elimination. You're looking for the secondary as a secondary.
我不清楚上肢端是否有任何特定正在進行中的工作,但我們對於氣動加壓治療在上肢患者中的定位與採用情況感到非常滿意,尤其是在治療師與腫瘤科領域——可以說這點已被充分理解。相較之下,下肢淋巴水腫幾乎是「排除法」的診斷流程;你是在找次發性原因,把它當作次要因素來判斷。
Certainly, with patients that have cancer, you know that you have removed a lymph node or you know that you've done something with the lymphatic system during a surgical procedure that's different than lower extremity. So we tend to see that in the oncology space and with lymphedema therapists, there's more understanding of the lymphatic disruption that's happened with the specific oncology intervention.
當然,對於癌症患者,你知道已切除淋巴結,或你知道在手術過程中對淋巴系統做了某些處置;這與下肢情況不同。因此我們在腫瘤領域與淋巴水腫治療師族群中,看到對於特定腫瘤介入所造成的淋巴系統破壞,有更高的理解程度。
So guidelines could be helpful, but it isn't as much of a disconnect, if you will, than we've seen in the lower extremity.
所以指引可能會有幫助,但相較於我們在下肢看到的情況,這裡的落差(disconnect)並沒有那麼大。
Benjamin Haynor - Analyst
Benjamin Haynor - Analyst
So numerically, you have not only more patients, but less penetration, if you will, amongst that group. So it's kind of a double whammy, theoretically, for you guys.
所以從數字上來看,不僅患者更多,而且在那個族群中的滲透率也更低。理論上,這對你們而言算是「雙重利多」。
Sheri Dodd - Chief Executive Officer, Director
Sheri Dodd - Chief Executive Officer, Director
Can you say that again? I wasn't sure what --
你可以再說一次嗎?我不太確定你指的是——
Benjamin Haynor - Analyst
Benjamin Haynor - Analyst
There are more patients with lower limb lymphedema, but they're also less penetrated. So it provides a bit of a double whammy for the benefit as these guidelines get published and more clinicians are inclined to push patients towards PCDs.
下肢淋巴水腫的患者更多,但滲透率也更低。因此,隨著這些指引發表、更多臨床醫師更傾向把患者導向 PCD,對你們的效益會有點像「雙重利多」。
Elaine Birkemeyer - Chief Financial Officer
Elaine Birkemeyer - Chief Financial Officer
I think maybe -- I think it's accurate that the lower extremity is the larger population. I think what Sheri is saying is that the guidelines are more meaningful for this population because there's not an obvious trigger to this lymphatic disruption. And so these guidelines really help if they get discovered earlier versus an upper extremity, there is an obvious trigger. And so, patients and clinicians are more likely to watch out for it in absence of guidelines.
我想——我認為下肢確實是較大的族群。我想 Sheri 的意思是,這些指引對這個族群更有意義,因為這裡沒有一個明顯的觸發因素導致淋巴系統受損。因此,這些指引若能讓疾病更早被發現,就會很有幫助;相較之下,上肢有明顯的觸發因素,所以即使沒有指引,患者與臨床醫師也更可能提高警覺並留意。
Benjamin Haynor - Analyst
Benjamin Haynor - Analyst
I think we're on the same page. Perfect. And lastly, for me, if I could sneak in one more, is there any call you can provide on this new pharmaceutical out there for bronchiectasis? Is there any impact that you guys find notable on the airway clearance side of things?
我想我們理解一致。很好。最後我再偷問一題:針對目前市面上這個治療支氣管擴張症的新藥,您能否分享一些看法?在氣道清除(airway clearance)這一端,你們是否看到任何值得注意的影響?
Sheri Dodd - Chief Executive Officer, Director
Sheri Dodd - Chief Executive Officer, Director
Certainly. I mean, we have said and believe that the introduction of the pharmaceutical products specifically for patients with bronchiectasis is helping awareness for the broader category. So it's been a nice category lift.
當然。我們一直表示並且相信,針對支氣管擴張症患者所推出的藥物產品,有助於提升更廣泛類別的疾病認知。因此這對整個類別帶來了不錯的拉抬。
The airway clearance, though, and they call it the vicious vortex, is that you have issues of inflammation, and you've got mucus, and then you have infection. And so what the pharmaceutical product does is it helps support inflammation, but inflammation is just one part of this whole vicious vortex associated with bronchiectasis.
不過,氣道清除——他們稱之為「惡性渦旋(vicious vortex)」——是因為你會有發炎問題,接著有黏液,然後又有感染。因此藥物產品所做的是協助處理發炎,但發炎只是支氣管擴張症這整個惡性渦旋中的一部分。
So there's still going to be inflammation, and with inflammation, you're still going to have mucus, and with mucus, you're still going to have opportunity for infection. So that need to actually clear the airway is still very relevant for this patient population. And this is what we're hearing from our clinicians, and this is the positioning with the product as well, is not to say it replaces airway clearance. It's actually alongside, could be used alongside an adjacent tube, but it is not one versus the other.
所以仍然會有發炎;有發炎就仍會有黏液;有黏液就仍會有感染的機會。因此,實際清除氣道的需求對這個患者族群仍然非常重要。這也是我們從臨床醫師那裡聽到的;產品的定位也是如此——並不是說它取代氣道清除。它其實是並行的,可以與(例如)相鄰的管路一起使用,但不是二選一。
So happy that it's helping grow awareness, happy that it's creating education around the disease of bronchiectasis, but not seeing this not only is the product portfolio and properties allowing for it to change the actual care pathway for these patients is just an option to be used alongside of an airway clearance product.
所以我們很高興它有助於提升認知,也很高興它在支氣管擴張症的疾病教育上有所助益;但我們並不認為它會對這些患者的實際照護路徑造成改變——它只是可與氣道清除產品並用的一個選項。
Benjamin Haynor - Analyst
Benjamin Haynor - Analyst
Makes sense. Thanks for taking the questions, and congrats on the quarter.
了解。謝謝接受提問,也恭喜本季表現。
Operator
Operator
And ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines, and have a wonderful day.
各位女士、先生,感謝各位的參與。今天的電話會議到此結束。您可以掛斷電話,祝您有美好的一天。