Cvrx, Inc (CVRX) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Greetings, and welcome to the CVRx Q1 2026 earnings call. (Operator Instructions) As a reminder, this conference is being recorded.

    各位好,歡迎參加 CVRx 2026 年第一季財報電話會議。(接線員指示) 提醒各位,本次會議將被錄音。

  • It is now my pleasure to introduce your host, Mike Vallie, from ICR Healthcare. Thank you. You may begin.

    現在我很榮幸介紹今天的主持人,來自 ICR Healthcare 的 Mike Vallie。謝謝。您可以開始了。

  • Mike Vallie - Analyst

    Mike Vallie - Analyst

  • Good afternoon. Thank you for joining us today for CVRx's first quarter 2026 earnings conference call. Joining me on today's call are the company's President and Chief Executive Officer, Kevin Hykes; and Chief Financial Officer, Jared Oasheim.

    各位下午好。感謝各位今天參加 CVRx 2026 年第一季財報電話會議。今天與我一同出席的有公司總裁兼執行長 Kevin Hykes,以及財務長 Jared Oasheim。

  • The remarks today will contain forward-looking statements, including statements about financial guidance. These statements are based on plans and expectations as of today, which may change overtime. In addition, actual results could differ materially due to a number of risks and uncertainties, including those identified in the earnings release issued prior to this call and in the company's SEC filings.

    今天的發言將包含前瞻性陳述,包括關於財務指引的陳述。這些陳述係基於截至今日的計畫與預期,且可能隨時間而改變。此外,由於多項風險與不確定性,實際結果可能與前述陳述存在重大差異,其中包括在本次電話會議前發布的財報新聞稿以及公司向 SEC 提交之文件中所揭露者。

  • I would now like to turn the call over to CVRx's President and Chief Executive Officer, Kevin Hykes.

    現在我想把電話交給 CVRx 總裁兼執行長 Kevin Hykes。

  • Kevin Hykes - President, Chief Executive Officer, Director

    Kevin Hykes - President, Chief Executive Officer, Director

  • Thanks, Mike. Good afternoon, and thank you for joining our first-quarter 2026 earnings call. We delivered a strong start to 2026, exceeding the high end of our guidance range, driven by 22% growth in the United States. The investments we made throughout 2025 are beginning to positively impact our results. Last year, we worked deliberately to strengthen our sales organization, refine our go-to-market approach, advance critical reimbursement initiatives, and to secure approval for our landmark clinical trial.

    謝謝你,Mike。各位下午好,感謝各位參加我們 2026 年第一季財報電話會議。我們在 2026 年取得強勁開局,業績超越指引區間上緣,主要由美國市場 22% 的成長所帶動。我們在 2025 年所做的投資正開始對業績產生正面影響。去年,我們有計畫地強化銷售組織、精進上市策略、推進關鍵的給付(reimbursement)倡議,並取得我們具里程碑意義之臨床試驗的核准。

  • This quarter shows early evidence that the foundation we have built is translating into results. As we move through 2026, we remain focused on executing against the same three strategic priorities that have guided our work to date, building a world-class sales organization, driving deep adoption in targeted centers, and continuing to reduce the barriers to adoption of Barostim therapy.

    本季已初步顯示,我們所建立的基礎正在轉化為成果。隨著我們推進 2026 年,我們仍專注於執行迄今指引我們工作的同樣三項策略優先事項:打造世界級銷售組織、在目標中心推動深度採用,以及持續降低 Barostim 治療的採用障礙。

  • Starting with our sales organization, we're pleased with the progress we're seeing from the team. We're seeing meaningful contributions from a broader and more experienced sales team, reflecting the quality of talent we've been able to attract, the discipline we've brought to onboarding and training, and the program-focused selling approach that the team is increasingly comfortable executing. We continue to expand both our active in-planning center base and our territory footprint during the quarter, and we expect to maintain this cadence of expansion through the balance of the year.

    先從銷售組織談起,我們對團隊目前的進展感到滿意。我們看到更廣泛且更有經驗的銷售團隊帶來實質貢獻,反映出我們所吸引的人才品質、我們在到職導入與訓練上所建立的紀律,以及團隊愈來愈能熟練執行的以專案為導向的銷售方式。本季我們持續擴大正在規劃中的活躍中心基礎以及我們的區域覆蓋範圍,並預期在今年剩餘期間維持此一擴張節奏。

  • Our second priority is driving deep adoption in the centers we've targeted. Our program-focused playbook emphasizes intentional targeting, building a redundant network of clinical and administrative stakeholders, and establishing a defined Barostim workflow. In the accounts where all of these elements are in place, we're seeing Barostim becoming part of how heart failure is routinely managed, rather than an episodic consideration, resulting in higher utilization. This remains the foundation for the long-term growth of our business.

    我們的第二項優先事項,是在我們鎖定的中心推動深度採用。我們以專案為導向的作戰手冊強調有意識的目標鎖定、建立臨床與行政利害關係人的冗餘網絡,以及建立明確的 Barostim 工作流程。在上述要素都到位的帳戶中,我們看到 Barostim 正逐步成為心衰竭日常常規管理的一部分,而非偶發性的考量,因而帶來更高的使用量。這仍是我們業務長期成長的基礎。

  • Our third priority is continuing to address the three fundamental barriers to the adoption of Barostim therapy: patient access, therapy awareness, and clinical evidence. We made meaningful progress on all three fronts in the first quarter. Starting with patient access, the transition to Category I CPT codes, which took effect on January 1, is the most significant reimbursement advancement in our company's history, and we're already beginning to see its impact.

    我們的第三項優先事項,是持續解決 Barostim 治療採用的三大根本障礙:病患可近性、治療認知度,以及臨床證據。第一季我們在這三個面向都取得實質進展。先談病患可近性,自 1 月 1 日生效的 Category I CPT 代碼轉換,是公司史上最重大的給付進展,我們已開始看到其影響。

  • Our 30-day Medicare Advantage prior authorization approval rate for submissions managed by our in-house market access team was 46% for the first quarter of 2026, as compared to 31% in 2024 and 44% in 2025. Within the quarter, our approval rate was 50% through the first two months before declining in March.

    2026 年第一季,由我們內部市場准入團隊管理之送件的 30 天 Medicare Advantage 事前授權核准率為 46%,相較之下,2024 年為 31%,2025 年為 44%。就本季內部而言,前兩個月核准率為 50%,但在 3 月有所下滑。

  • While we are encouraged by the underlying year-over-year improvement tied to the new Category I code, the March softening reflects the impact of simultaneous changes in the broader reimbursement environment that are affecting our company and others across the medical device industry.

    雖然我們對與新的 Category I 代碼相關、年對年改善的基本趨勢感到鼓舞,但 3 月的走弱反映了更廣泛給付環境中同步變動的影響,這些變動正影響我們公司以及醫療器材產業中的其他公司。

  • Effective January 1, new regulations require Medicare Advantage payers to respond with a decision to a prior authorization request within three or seven days, depending on urgency, as compared to the previous 14-day requirement. As a result, certain payers implemented new automated review processes beginning in late February in response to these compressed timeline requirements.

    自 1 月 1 日起,新法規要求 Medicare Advantage 付款方必須在 3 天或 7 天內(視緊急程度而定)對事前授權申請做出決定,相較於先前 14 天的要求。因此,部分付款方為因應這些縮短的時程要求,自 2 月下旬起導入新的自動化審查流程。

  • This has resulted in a higher rate of initial denials, particularly in March, on the basis of an experimental designation, even for therapies with established Category I codes and well-documented clinical evidence. Importantly, this is not a reflection of a change in the clinical or coverage rationale for Barostim. This is a new administrative dynamic that is being seen broadly across the device industry, which is not unique to our therapy.

    這導致初次拒絕的比例上升,特別是在 3 月,拒絕理由多以「實驗性」標示為主,即便是已具 Category I 代碼且臨床證據充分的治療亦然。重要的是,這並不代表 Barostim 的臨床或給付依據有所改變。這是一種新的行政面動態,正廣泛出現在整個器材產業,並非我們療法所獨有。

  • We believe that this is simply a timing issue and not a change to the ultimate approval rates, because when our market access team appeals these decisions with additional clinical documentation, most of the initial denials are overturned successfully. While the underlying coverage position for Barostim has never been stronger, our goal is to adapt to this changing environment and to ensure that every submission meets this increasing administrative scrutiny on the front end.

    我們認為這只是時點問題,而非最終核准率的改變,因為當我們的市場准入團隊以額外臨床文件提出申覆時,多數初次拒絕都能成功被推翻。雖然 Barostim 的基本給付立場從未如此強勁,我們的目標是因應這個變動中的環境,並確保每一份送件在前端就能符合日益提高的行政審查要求。

  • Our market access team is implementing this approach with patients and providers through our in-house prior authorization service, as well as supporting physician practices with their independent prior authorization efforts to ensure that they effectively navigate this changing environment.

    我們的市場准入團隊正透過公司內部的事前授權服務,與病患及醫療提供者落實此一作法,同時也支援醫師診所自行進行的事前授權作業,以確保他們能有效因應這個變動中的環境。

  • We believe the long-term trajectory for patient access remains strongly positive, and we expect these payer processes to continue to normalize as the industry adjusts to the new regulatory framework. As it relates to therapy awareness, we continued to expand our medical education efforts during the quarter, with a particular focus on the advanced practice providers who manage most of our indicated heart failure patients in the community.

    我們相信病患可近性的長期走勢仍將維持強勁正向,我們也預期隨著產業適應新的法規框架,這些付款方流程將持續回歸常態。在治療認知度方面,本季我們持續擴大醫學教育工作,特別聚焦於在社區中管理我們多數適應症心衰竭病患的進階執業提供者(advanced practice providers)。

  • We also had a meaningful presence at several important cardiology meetings during the quarter, including multiple presentations at the THT and ACC meetings that reflect the growing body of clinical evidence supporting Barostim. These engagements continue to drive strong interest in Barostim therapy among the clinicians who are best positioned to identify candidates for treatment. Additionally, shortly after the first quarter, we piloted our first educational symposium focused on nurses in community cardiology practices, extending our outreach beyond advanced practice providers to the registered nurse coordinators who also play a key role in managing heart failure patients in the community.

    本季我們也在數個重要的心臟科會議上有顯著參與,包括在 THT 與 ACC 會議上的多場發表,反映支持 Barostim 的臨床證據持續累積。這些互動持續推動對 Barostim 治療的高度興趣,特別是在最有能力辨識治療候選人的臨床醫師族群中。此外,在第一季結束後不久,我們試辦了首場以社區心臟科診所護理人員為主的教育研討會,將觸及範圍從進階執業提供者延伸至同樣在社區心衰竭病患管理中扮演關鍵角色的註冊護理師協調員。

  • In terms of clinical evidence, the recently initiated BENEFIT-HF trial is a landmark randomized controlled trial evaluating Barostim in an expanded population of heart failure patients with ejection fractions up to 50% and NT-proBNP levels up to 5,000. If successful, this trial would expand our prevalence-based addressable market from approximately 339,000 patients today to over 980,000 patients, effectively tripling our market opportunity to approximately $30 billion.

    在臨床證據方面,近期啟動的 BENEFIT-HF 試驗是一項具里程碑意義的隨機對照試驗,評估 Barostim 在擴大之心衰竭病患族群中的效果,納入射出分率最高至 50%、且 NT-proBNP 最高至 5,000 的病患。若試驗成功,將使我們以盛行率為基礎的可觸及市場,從目前約 339,000 名病患擴大至超過 980,000 名病患,等同將我們的市場機會有效提升至約三倍、約 300 億美元。

  • I'm pleased to share that we activated the first site in our BENEFIT-HF trial in the first quarter and enrolled our first patient last week. The feedback from the heart failure community on the rigor and scale of the trial design has been very positive. Beyond the clinical objectives of the trial, we're seeing meaningful engagement from centers that are interacting with us for the first time because of BENEFIT-HF, which we believe will contribute to broader awareness and visibility for Barostim therapy.

    我很高興分享,我們在第一季於 BENEFIT-HF 試驗中啟動了第一個研究中心,並於上週納入了第一位受試者。心衰竭領域對此試驗設計的嚴謹性與規模所給予的回饋非常正面。除試驗的臨床目標之外,我們也看到一些中心因 BENEFIT-HF 而首次與我們互動並展現實質參與,我們相信這將有助於提升 Barostim 治療的更廣泛認知與能見度。

  • To wrap up, the first quarter reflects positive momentum across every part of our business. Our sales team is executing, the reimbursement environment is improving, and our clinical evidence program is advancing on schedule. We remain focused on continuing to execute through the balance of 2026, and we're confident in the path ahead.

    總結來說,第一季反映出我們業務各個面向的正向動能。我們的銷售團隊執行到位、給付環境正在改善,而我們的臨床證據計畫也按進度推進。我們仍專注於在 2026 年剩餘期間持續落實執行,並對未來的發展路徑充滿信心。

  • Now, I'd like to turn the call over to Jared for a financial review.

    現在,我想把電話會議交給 Jared 進行財務回顧。

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • Thanks, Kevin. Unless otherwise stated, year-over-year comparisons are for the three months ended March 31, 2026, compared to the three months ended March 31, 2025. In the first quarter, total revenue generated was $14.8 million, an increase of $2.4 million, or 20%. Revenue generated in the US was $13.7 million, an increase of $2.5 million, or 22%.

    謝謝,Kevin。除非另有說明,年對年比較係指截至 2026 年 3 月 31 日止三個月,與截至 2025 年 3 月 31 日止三個月相比。第一季總營收為 1,480 萬美元,增加 240 萬美元,增幅 20%。美國地區營收為 1,370 萬美元,增加 250 萬美元,增幅 22%。

  • Revenue units in the US totaled 429 and 359 for the three months ended March 31, 2026, and 2025, respectively. The increases were primarily driven by continued growth in the US heart failure business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim.

    美國地區的營收單位數分別為截至 2026 年 3 月 31 日止三個月的 429,以及截至 2025 年 3 月 31 日止三個月的 359。成長主要來自美國心衰竭業務的持續擴張,原因包括拓展至新的銷售區域、開發新客戶,以及醫師與病患對 Barostim 的認知提升。

  • We ended the quarter with a total of 257 active implanting centers, as compared to 252 as of December 31, 2025. We had 56 sales territories in the US at the end of the quarter, compared to 53 at the end of 2025, and 45 on March 31, 2025. Revenue generated in Europe was $1.1 million, a decrease of $27,000, or 2%. Total revenue units in Europe decreased to 56 from 59 in the prior year period. The number of sales territories in Europe remained consistent at 5.

    本季結束時,我們共有 257 家活躍植入中心,相較於 2025 年 12 月 31 日的 252 家。本季末美國共有 56 個銷售區域,較 2025 年底的 53 個增加,亦高於 2025 年 3 月 31 日的 45 個。歐洲地區營收為 110 萬美元,減少 2.7 萬美元,降幅 2%。歐洲地區總營收單位數由去年同期的 59 降至 56。歐洲的銷售區域數維持不變,仍為 5 個。

  • Gross profit was $12.9 million for the three months ended March 31, 2026, an increase of $2.6 million, or 25%. Gross margin increased to 87% compared to 84% a year ago. Gross margin was higher due to an increase in the average selling price and a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies.

    截至 2026 年 3 月 31 日止三個月,毛利為 1,290 萬美元,增加 260 萬美元,增幅 25%。毛利率提升至 87%,高於一年前的 84%。毛利率提高主要因平均售價上升及單位成本下降,單位成本下降主要來自製造效率提升。

  • R&D expenses increased $0.6 million, or 23%, to $3.1 million compared to the prior-year period. This change was driven by an increase in consulting expenses, compensation expenses, and non-cash stock-based compensation expenses, partially offset by a decrease in clinical trial expenses.

    研發費用較去年同期增加 60 萬美元(增幅 23%)至 310 萬美元。此變動主要由顧問費用、薪酬費用及非現金股份基礎給付費用增加所致,部分被臨床試驗費用下降所抵銷。

  • SG&A expenses increased $0.7 million, or 3%, to $22 million, compared to the prior year period. This change was primarily driven by an increase in compensation expenses and non-cash stock-based compensation expenses partially offset by a decrease in consulting expenses and advertising expenses. Interest expense increased $94,000 to $1.6 million compared to a year ago. This increase was driven by the increased borrowings under the term loan agreement with Innovatus Capital Partners.

    銷售、一般及行政(SG&A)費用較去年同期增加 70 萬美元(增幅 3%)至 2,200 萬美元。此變動主要由薪酬費用及非現金股份基礎給付費用增加所致,部分被顧問費用及廣告費用下降所抵銷。利息費用較一年前增加 9.4 萬美元至 160 萬美元。此增加係因依 Innovatus Capital Partners 的定期貸款協議之借款增加所致。

  • Other income net was $0.6 million compared to $1.1 million. These balances consisted of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance. Net loss was $13.1 million or $0.50 per share for the first quarter of 2026, compared to a net loss of $13.8 million or $0.53 per share for the first quarter of 2025.

    其他收益(淨額)為 60 萬美元,去年同期為 110 萬美元。上述金額主要為我們計息帳戶的利息收入。下降主要由現金餘額較低所致。2026 年第一季淨損為 1,310 萬美元(每股 0.50 美元),相較 2025 年第一季淨損 1,380 萬美元(每股 0.53 美元)。

  • Net loss per share was based on 26.4 million weighted average shares outstanding for the first quarter of 2026 and 25.9 million weighted average shares outstanding for the first quarter of 2026. As of March 31, 2026, cash and cash equivalents were $72.3 million. Net cash used in operating and investing activities was $12.3 million for the three months ended March 31, 2026, as compared to $12.9 million for the three months ended March 31, 2025.

    每股淨損係以 2026 年第一季加權平均流通股數 2,640 萬股,以及 2026 年第一季加權平均流通股數 2,590 萬股計算。截至 2026 年 3 月 31 日,現金及約當現金為 7,230 萬美元。截至 2026 年 3 月 31 日止三個月,營運及投資活動使用之淨現金為 1,230 萬美元,相較截至 2025 年 3 月 31 日止三個月為 1,290 萬美元。

  • Now turning to guidance. For the full year of 2026, we continue to expect total revenue between $63 million and $67 million. We now expect full-year gross margin between 85% and 87%. We continue to expect operating expenses to be between $103 million and $107 million. For the second quarter of 2026, we expect to report total revenue between $15.1 million and $16.1 million.

    接著談指引。對於 2026 全年,我們仍預期總營收介於 6,300 萬至 6,700 萬美元。我們目前預期全年毛利率介於 85% 至 87%。我們仍預期營業費用介於 1.03 億至 1.07 億美元。對於 2026 年第二季,我們預期總營收介於 1,510 萬至 1,610 萬美元。

  • With that, I'll now turn the call back over to Kevin for closing remarks.

    接下來,我把電話會議交回 Kevin 進行結語。

  • Kevin Hykes - President, Chief Executive Officer, Director

    Kevin Hykes - President, Chief Executive Officer, Director

  • Thank you, Jared. The first quarter reflects a strong start to the year and gives us confidence in the path ahead. Our sales organization is maturing, the reimbursement environment is improving, and the initiation of BENEFIT-HF opens a meaningful new chapter for our company and for the heart failure patients that we serve. We have more work to do, and we remain focused on execution as we continue to advance Barostim toward becoming a standard of care for the treatment of heart failure.

    謝謝你,Jared。第一季反映出今年強勁的開局,並讓我們對未來的道路更有信心。我們的銷售組織日益成熟,給付/報銷環境正在改善,而 BENEFIT-HF 的啟動為公司以及我們服務的心衰竭病患開啟了重要的新篇章。我們仍有更多工作要做,並將持續專注於執行,推動 Barostim 朝向成為心衰竭治療的標準照護。

  • Now, I'd like to open the line for questions. Operator?

    現在,我想開放提問。接線員?

  • Operator

    Operator

  • (Operator Instructions) Brandon Vazquez, William Blair.

    (接線員指示) Brandon Vazquez,William Blair。

  • Max Kruszeski - Analyst

    Max Kruszeski - Analyst

  • Hey, guys. It's Max on for Brandon. Thanks for taking the questions. Kevin, I just wanted to start with one on the prior authorization stuff. I understand that the dip in March was due to some of the automation that you mentioned. Can you just touch on how some of the practices you guys have put into place to address this have trended thus far? And higher level, what's included in 2026 guidance for any potential ongoing headwinds in that case?

    嗨,各位。我是 Max,代 Brandon 發問。謝謝讓我提問。Kevin,我想先問一個關於事前授權(prior authorization)的問題。我理解 3 月的下滑是因為你提到的一些自動化所致。你能否談談你們為解決此問題而採取的一些做法,到目前為止的趨勢如何?以及更高層次地說,2026 年指引中是否已納入此情況下任何可能持續的逆風?

  • Kevin Hykes - President, Chief Executive Officer, Director

    Kevin Hykes - President, Chief Executive Officer, Director

  • Sure. Thanks. Appreciate the question, Max. So I'll let Jared address the guidance piece. But upfront, as I mentioned, this was an unexpected and inadvertent effect of some new federal regulations that went into place on January 1.

    當然。謝謝。Max,感謝你的提問。指引的部分我會讓 Jared 來回答。但先說明一下,如我提到的,這是一些於 1 月 1 日生效的新聯邦法規所造成的意外且非預期的影響。

  • We first saw this in late February, and what we saw was an increase in kind of immediate denials, often for, again, experimental reasons, but in fact, because of administrative gaps in the prior authorizations or effectively missing signatures or they're using AI, as we can best tell, to find any missing data they possibly can to serve as a grounds for immediately denying a prior authorization request, which then buys them the additional time they now need under the new rules to properly evaluate.

    我們在 2 月下旬首次看到這個情況;我們看到的是即時拒絕的情形增加,且往往是以「實驗性」等理由拒絕,但實際上是因為事前授權在行政流程上有缺口,或是缺少簽名;或者據我們所能判斷,他們使用 AI 去找出任何可能缺漏的資料,作為立即拒絕事前授權申請的依據,藉此在新規則下爭取他們現在所需要的額外時間來進行適當評估。

  • So we have responded, working closely, obviously, with an in-house team that does this day in and day out. We have lots of physicians who do it themselves, but have begun using our own AI tools to ensure that every possible T is crossed and I is dotted in these very lengthy prior authorization requests so that we can defeat this attempt to buy time, which is what we believe it effectively is. Importantly, what we're seeing, and this has been corroborated with partners across the industry through the back channels, we see a very healthy overturn rate.

    因此我們已做出回應,並且顯然與一個日常專責處理此事的內部團隊密切合作。我們有許多醫師會自行處理,但我們也開始使用自有的 AI 工具,確保在這些非常冗長的事前授權申請中,每一個細節都完整無誤,讓每個「T」都劃上、每個「I」都點上,以便破解我們認為其本質上是在爭取時間的作法。重要的是,我們所看到的情況——也已透過產業內合作夥伴的非正式管道獲得印證——是撤銷拒絕(overturn)的比率非常健康。

  • So we think this is really -- if it's a surprise, it's that these are taking a little longer than we thought they would. But the ultimate approval rates, we think, will be as good or better as the prior chapter under Category III. So I think it's a temporary situation. We're all working our way through it. But I think it's something that will not affect, ultimately, the approval rates for the therapy.

    所以我們認為這真的——如果說有什麼出乎意料,那就是這些流程花的時間比我們原先預期稍長。但我們認為最終核准率會與先前在第三類(Category III)階段一樣好,甚至更好。因此我認為這是暫時性的情況。我們都正在逐步克服它。但我認為這件事最終不會影響該療法的核准率。

  • Jared, do you want to cover the second part of the question?

    Jared,你想回答問題的第二部分嗎?

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • Yeah, happy to. And Max, just to clarify as well, one of the things that we're watching really closely is that 30-day approval rate. And so we just received that 30-day approval rate for March at the end of April, noting a slight decline from what we had seen in the January and February data. So I just wanted to clarify that piece.

    好啊,很樂意。另外 Max,我也想再澄清一下,我們正在非常密切關注的一件事是 30 天核准率。因此,我們在 4 月底收到了 3 月份的 30 天核准率數據,注意到相較於 1 月與 2 月的數據略有下滑。所以我只是想把這一點說清楚。

  • And then as for the guidance, we didn't really know what was going to happen with Category I. We assumed it would lead to more or higher approval rates for our prior authorizations that we're supporting in 2026, but we didn't want to bank on that as we were setting up the guidance for 2026. And so to hit the numbers that we had put in the initial guide, we assumed very consistent 30-day and 60-day approval rates for cases that required prior authorization support.

    至於財測指引,我們其實不太確定 Category I 會發生什麼。我們原本假設它會讓我們在 2026 年所支援的事前授權(prior authorization)帶來更多或更高的核准率,但在制定 2026 年指引時,我們不想把這點當作既定前提。因此,為了達到我們在初始指引中提出的數字,我們假設對於需要事前授權支援的案件,其 30 天與 60 天核准率會非常一致、維持穩定。

  • And so I think Kevin mentioned it in the prepared remarks, last year, we saw 30-day approval rates of roughly 44%. So far in Q1, we're at 46%, so doing slightly better year-to-date. And so if that continues, then we shouldn't see any issues as far as hitting the guide that we had initially set.

    所以我想 Kevin 在事先準備的講稿裡有提到,去年我們看到的 30 天核准率大約是 44%。到目前為止在第一季,我們是 46%,所以年初至今表現略好一些。因此如果這個趨勢持續下去,那麼在達成我們最初設定的指引方面,應該不會有任何問題。

  • Although, I'll just add, Kevin mentioned, longer-term, we're still expecting this to just be a timing issue. We do expect the appeals approval rate to be greater for these Category I cases as the documentation is refined. So we still expect there to be a greater final or terminal approval rate for these prior authorizations under Category I, but we're not going to bake that into guidance until we actually see it play through, play out.

    不過我再補充一下,Kevin 提到從較長期來看,我們仍預期這主要只是時間點(timing)的問題。隨著文件資料逐步完善,我們確實預期這些 Category I 案件的申訴(appeals)核准率會更高。因此,我們仍預期在 Category I 之下,這些事前授權的最終或終局核准率會更高,但在我們真正看到它實際發生、落地之前,我們不會把這點納入指引假設。

  • Max Kruszeski - Analyst

    Max Kruszeski - Analyst

  • That's helpful. And then just for a follow-up, congrats on enrolling the first patient BENEFIT-HF. How should we think about that progressing as the year moves on? And Kevin, I believe you mentioned in your prepared remarks that it was helping you guys get your foot in the door with some new centers that may not have been familiar with Barostim. Can you just talk to us about that dynamic specifically and then broader, how we should think about the ramp of the trial throughout the rest of the year? Thanks.

    這很有幫助。接著追問一下,恭喜在 BENEFIT-HF 納入第一位病人。隨著今年往後推進,我們應該如何看待這件事的進展?另外 Kevin,我記得你在事先準備的講稿裡提到,這有助於你們在一些可能不熟悉 Barostim 的新中心「打開大門」。你能否特別談談這個動態,以及更廣泛地說,我們應該如何看待今年剩餘時間試驗的招募爬坡(ramp)?謝謝。

  • Kevin Hykes - President, Chief Executive Officer, Director

    Kevin Hykes - President, Chief Executive Officer, Director

  • Sure. I'll maybe cover the second part first and let Jared cover your initial question. But as we've mentioned, this is a landmark trial in heart failure. It's a landmark trial for our company, the largest, we believe, therapeutic device trial ever done. There's kind of two ways to think about it.

    當然。我可能先回答第二部分,然後讓 Jared 回答你最初的問題。但如同我們提過的,這是一項心衰竭領域的里程碑試驗。對我們公司而言也是里程碑;我們相信這是史上規模最大的治療性器械試驗。大致可以用兩種方式來看待它。

  • If you think about the barriers to the adoption of therapy, which are awareness, evidence, and patient access, this trial touches on all three of those, and it's driven significant awareness for us. It will be a foundational element of our long-term evidence portfolio.

    如果你從治療採用(adoption)的障礙來看,也就是認知(awareness)、證據(evidence)與病人可近性(patient access),這項試驗同時涵蓋這三者,並且為我們帶來了顯著的認知提升。它也將成為我們長期證據組合(evidence portfolio)的基礎性要素。

  • And number three, the Category B designation effectively creates a national coverage decision for patients enrolled in this trial. And that's a population that's 3 times bigger than our current population. So it sort of checks all three boxes in terms of helping us further reduce barriers.

    第三,Category B 的指定實質上為參與此試驗的病人建立了一項全國性給付決定(national coverage decision)。而這個族群的規模是我們目前族群的 3 倍。因此就進一步降低障礙而言,它等於同時勾選了三個面向。

  • On a more practical level, it is indeed, for those ultraconservative centers that perhaps haven't yet been ready to adopt Barostim, it is an excellent engagement tool, and many of them are, in fact, willing to implant Barostim under the auspices of a trial like this.

    在更務實的層面上,確實如此:對於那些極度保守、可能尚未準備好採用 Barostim 的中心而言,這是一個非常好的互動與切入工具(engagement tool),而且其中許多中心確實願意在此類試驗的框架之下植入 Barostim。

  • For those that have already adopted Barostim, it's an equally interesting engagement tool because it allows them to treat many more patients, often patients they're turning away for Barostim today. So I think there are a number of different tailwinds. We've not necessarily baked those into our data yet, but we think and have already seen evidence that this is seen as a leadership, confidence-boosting signal from the company, and a project that many of our physicians want to be part of.

    對於已經採用 Barostim 的中心而言,這同樣是一個很有吸引力的互動工具,因為它讓他們能治療更多病人,往往是他們今天因 Barostim 適用條件而不得不婉拒的病人。所以我認為有多種不同的順風因素(tailwinds)。我們不一定已把這些反映到我們的數據裡,但我們認為、也已看到一些證據顯示,外界把這視為公司展現領導力、提升信心的訊號,且是許多醫師希望參與的專案。

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • Yeah. And Max, to address the ramp question. So we are really happy to see the first couple of sites activated, that first patient enrolled in the trial so early in the year. But we are still being a little cautious as far as what we're going to bake into expectations for 2026.

    是的。Max,針對你問的爬坡問題。我們很高興看到年初就有前幾個站點(sites)完成啟動,並且這麼早就有第一位病人納入試驗。但就 2026 年我們要納入預期(expectations)的內容而言,我們仍會稍微保守一些。

  • So we're going to need a little bit more experience with our site activation process before we start setting expectations on how many new sites could be activated each month and therefore by the end of this year. So we're starting to think about this. In terms of multiple quarters, maybe multiple years to get all of these sites up and running. It could take 12 to 24 months to get to that target of 150 sites activated and fully starting to enroll this trial.

    因此,在我們開始設定每月可啟動多少新站點、以及因此到今年年底可啟動多少站點的預期之前,我們需要在站點啟動流程上累積更多經驗。所以我們開始把這件事視為以多個季度、甚至多年的尺度來推進,才能讓所有站點上線運作。要達到 150 個站點完成啟動並全面開始招募此試驗的目標,可能需要 12 到 24 個月。

  • Max Kruszeski - Analyst

    Max Kruszeski - Analyst

  • That's helpful. Thanks, guys.

    這很有幫助。謝謝各位。

  • Kevin Hykes - President, Chief Executive Officer, Director

    Kevin Hykes - President, Chief Executive Officer, Director

  • John Young, Canaccord Genuity.

    John Young,Canaccord Genuity。

  • John Young - Equity Analyst

    John Young - Equity Analyst

  • Hey, Kevin and Jared, thanks for taking the question and congratulations on the quarter. I just wanted to start off on the reiteration of the revenue guidance. You guys had a solid Q1 beat. And I'm wondering, the reiteration itself, is that just Q1 conservatism or are you seeing anything maybe beyond the reimbursement dynamics that you already highlighted as we sit here in May?

    嗨,Kevin 和 Jared,謝謝你們回答問題,也恭喜本季表現。我想先從你們重申營收指引談起。你們第一季表現強勁、優於預期。我想問,這次重申本身,是只是第一季偏保守的作法,還是截至 5 月、除了你們已提到的報銷(reimbursement)動態之外,你們還看到其他因素?

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • Yeah, happy to take that one, John. So yeah, I mean, one quarter in at this point, this is a year where we are reaccelerating our growth rate after doing a lot of team building and rebuilding kind of the ground floor of the company over the last couple of years. And so we just simply didn't want to get ahead of ourselves from a guide perspective.

    好的,John,我很樂意回答。是的,我的意思是,目前才剛過第一季;今年是在過去幾年做了大量團隊建置與重建、把公司的基礎打好之後,我們正在讓成長率重新加速的一年。因此從指引角度來看,我們只是單純不想操之過急。

  • With updating the full-year number after just the first quarter. So we're really happy with the results of seeing that reacceleration get back to 20% growth, but just don't want to get ahead of ourselves by updating guide too early in the year.

    在只有第一季數據之後就去更新全年數字。所以我們對於看到成長重新加速、回到 20% 的成長率感到非常滿意,但也不想在年初就太早更新指引、走在自己前面。

  • John Young - Equity Analyst

    John Young - Equity Analyst

  • Great. Thanks, Jared. And to also just touch on the MA prior authorization. When they get close to 50%, can you just remind us again of willingness of MA payers to create policies? And can you also remind us again, do you need prior authorization for patients enrolled in BENEFIT-HF?

    了解。謝謝,Jared。另外也想談一下 MA(Medicare Advantage)事前授權。當核准率接近 50% 時,你能再提醒我們一次 MA 付款方(payers)制定政策(policies)的意願如何嗎?也請再提醒我們一次,BENEFIT-HF 試驗中納入的病人是否需要事前授權?

  • Kevin Hykes - President, Chief Executive Officer, Director

    Kevin Hykes - President, Chief Executive Officer, Director

  • Sure. Thanks, John. So I'll take the second first. The short answer is no, we don't, which is obviously a benefit. So patients that are eligible and enrolled in the trial will be treated almost as traditional Medicare patients, no prior authorization required. So that's a positive. As it relates to the first question, can you remind me?

    當然。謝謝,John。我先回答第二個。簡短答案是不需要,這顯然是一項好處。因此,符合資格並納入試驗的病人,幾乎會被視同傳統 Medicare 病人來治療,不需要事前授權。所以這是正面的。至於第一個問題,你可以再提醒我一下嗎?

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • Yeah. If you get greater than a 50% --

    可以。如果你超過 50% --

  • Kevin Hykes - President, Chief Executive Officer, Director

    Kevin Hykes - President, Chief Executive Officer, Director

  • Yeah. No. So John, the way this works, and we've described it sort of as a war of attrition. But effectively, roughly 10% of all denials are ever appealed. Those that are appealed across the spectrum, 80%-plus of them are ultimately approved. So it's really about -- it's about not giving up and being tenacious in the way that we appeal each and every denial. And the number we've quoted, if you push it all the way to the end of the process, which is the administrative law judge review.

    是的。不是。所以,John,這個運作方式,我們把它形容得有點像一場消耗戰。但實際上,大約只有所有拒賠中的約10%會被提出申訴。而在各類被申訴的案件中,最終有超過80%會獲得核准。所以重點其實在於——在我們對每一筆拒賠逐一提出申訴時,不要放棄並且要堅持到底。而我們引用的那個數字,是指如果你把流程一路推到最後,也就是行政法官(ALJ)審查。

  • The industry data would suggest once the payers begin losing not even 50% of those -- high 40%s, they will then begin to approve without having to go to ALJ because the ALJ process is expensive and they bear that cost. So that's maybe the number you're referring to. It's about 48% from what we understand.

    產業數據顯示,一旦付款方開始在那些案件中輸掉的比例甚至不到50%——大概是40%後段,他們就會開始在不必走到ALJ的情況下直接核准,因為ALJ流程成本很高,而且那個成本由他們承擔。所以那可能就是你指的那個數字。就我們了解,大約是48%。

  • John Young - Equity Analyst

    John Young - Equity Analyst

  • And just to follow-up on that, is there any expectations on your end of when we could approach that number?

    再追問一下,你們這邊是否預期何時能接近那個數字?

  • Kevin Hykes - President, Chief Executive Officer, Director

    Kevin Hykes - President, Chief Executive Officer, Director

  • We are starting to see -- we're in that neighborhood with a number of payers already. And I guess I didn't answer the part of your question. Once you cross that threshold, you then ideally move into a situation where you often have silent coverage. So they don't yet have a written policy, but they are in fact approving.

    我們已經開始看到——對於一些付款方,我們已經在那個區間附近了。而我想我沒有回答你問題的另一部分。一旦你跨過那個門檻,理想情況下就會進入一種狀態:你常常會有「默示給付範圍」。也就是他們還沒有書面政策,但實際上確實在核准。

  • Eventually, then you move on to a written coverage policy through a number of different mechanisms. So that's still some years away, but we're pleased with what we're seeing as we move through this process, and we're pleased with the number of these administrative law appeals that we ultimately win.

    接著最終,你會透過多種不同機制,進一步走向書面給付政策。所以那可能還要好幾年,但我們對於在這個流程中所看到的進展感到滿意,也對我們最終贏得這些行政法申訴案件的數量感到滿意。

  • John Young - Equity Analyst

    John Young - Equity Analyst

  • Great. Thank you.

    很好。謝謝。

  • Operator

    Operator

  • Matt O'Brien, Piper Sandler.

    Matt O'Brien,Piper Sandler。

  • Unidentified Participant

    Unidentified Participant

  • Hi, this is Sam on for Matt. Thank you so much for taking our question. I guess firstly, I just wanted to touch on that ASP in the quarter, which looks really nice. It's a little bit different than historical seasonality, where we see a dip in Q1. Can you talk about your expectations for ASP the rest of the year? And is this related to the Cat I code and any other details there would be great.

    嗨,我是代替Matt的Sam。非常感謝讓我們提問。我想首先想談一下本季的ASP,看起來非常不錯。這跟過去的季節性有點不同,因為我們通常會在第一季看到下滑。你能談談你們對今年剩餘時間ASP的預期嗎?這是否與Cat I代碼有關?若能提供其他細節也很棒。

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • Yeah, happy to take that one, Sam. So I think we're seeing close to $32,000 ASPs on the US business for the first quarter, a nice step up again from the average that we saw in 2025, closer to $31,500. I'm still a little reluctant to bake that into expectations throughout 2026 at this point in time, kind of expecting that number to be around $31,000 or maybe $31,500 throughout the year. But we are. Incentivizing the sales team to go out and capture as high of an ASP as possible. So the team will continue to push on that to see that number potentially grow over time, just not baking that into expectations for '26.

    好的,Sam,我很樂意回答。所以我想我們看到美國業務第一季的ASP接近32,000美元,相較於我們在2025年看到的平均值(更接近31,500美元)又有不錯的提升。但就目前而言,我仍有點不太願意把這個水準納入2026年全年的預期;我比較預期今年大概會在31,000美元或31,500美元左右。不過我們確實——在激勵銷售團隊盡可能爭取更高的ASP。因此團隊會持續推動,讓這個數字隨時間有機會成長,只是我們不把它直接寫進對2026年的預期。

  • Unidentified Participant

    Unidentified Participant

  • Okay, that's helpful. Thank you. And then also going back and touching on BENEFIT-HF, how long do you anticipate this trial to enroll? And any expectations on ultimately when you think potentially the TAM could triple?

    好的,這很有幫助。謝謝。另外再回到BENEFIT-HF,你們預期這項試驗需要多久才能完成收案?以及你們是否預期最終TAM可能在何時成長到三倍?

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • Yeah, it's a good question. As we laid out this trial, we talked about a timeline of five to seven years, knowing that once we fully enroll the trial, there's going to be a two-year follow-up period for that final patient. So if we kind of hit the middle of that target, it would take about four years to enroll the 2,500 patients. And then two years afterwards to follow them up. So you're talking six years from the beginning of the trial this year out into the early 2030s before we could potentially see that FDA approval?

    是的,這是個好問題。在我們規劃這項試驗時,我們談到的時間軸是5到7年,因為我們知道一旦完成全數收案,最後一位受試者還需要兩年的追蹤期。所以如果我們取目標區間的中間值,大約需要4年才能收滿2,500名患者。然後再用兩年做追蹤。所以你說的是,從今年試驗開始算起大約6年,直到2030年代初期,我們才可能看到FDA核准?

  • Unidentified Participant

    Unidentified Participant

  • Got it. Thank you.

    了解。謝謝。

  • Operator

    Operator

  • Frank Takkinen, Lake Street Capital Markets.

    Frank Takkinen,Lake Street Capital Markets。

  • Frank Takkinen - Senior Research Analyst

    Frank Takkinen - Senior Research Analyst

  • Great. Thank you for taking the questions. I was hoping to start with a conversation around some higher utilization sites. I think previously you've spoke to top 20% of sites averaging in the neighborhood of 1.5 procedures per month. Can you maybe speak to that top 20% cohort, what their utilization rates are looking like today? And then any commentary towards kind of the opposite of that question of more sites graduating into that 1.5 per month rate?

    很好。謝謝讓我提問。我想先從一些使用量較高的據點談起。我記得你們之前提到,前20%的據點平均大約每月1.5例手術。你能談談目前這個前20%族群的使用率看起來如何嗎?另外也想請你評論一下相反的問題:是否有更多據點正在「升級」到每月1.5例的水準?

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • Yeah, I appreciate the question, Frank. We were trying to draw a line in the sand for investors and the outside community to understand what is possible with these centers. And so we pulled that as an ad hoc analysis in the fourth quarter for our top 20% of centers to note that they were doing more than one patient per center per month to show what is possible for these centers as we continue to build out our programs.

    好的,Frank,謝謝你的問題。我們當時是想為投資人和外部社群畫出一條界線,讓大家理解這些中心能做到什麼程度。因此我們在第四季做了一個臨時分析,針對我們前20%的中心,指出它們每個中心每月做超過一位患者,以展示在我們持續建置計畫的過程中,這些中心的潛力。

  • I don't think it's going to be a metric that we're going to share on a quarterly basis because we do know that there is some seasonality that plays in as we look to the results from Q4 then going into Q1. But maybe on an annual basis, doing a reflection of how many more of those centers are now reaching that threshold of hitting one patient a month. So maybe given a refresh on that number in Q4 this year.

    我不認為這會成為我們每季都會分享的指標,因為我們知道從第四季到第一季的結果來看,確實會受到一些季節性影響。但也許我們會以年度為基礎回顧:有多少中心現在達到每月一位患者的門檻。所以可能會在今年第四季更新這個數字。

  • Frank Takkinen - Senior Research Analyst

    Frank Takkinen - Senior Research Analyst

  • Okay, fair enough. And then maybe I'll try another one that you may be reluctant to answer, but can you speak to prior auth rates in April by chance? And just trying to understand if we had 50% in the first two months and then ended at 46%, I think that implies that March was maybe high 30s, and just curious if it was kind of up or down from that prior auth rate.

    好的,合理。那我再試問一個你可能不太願意回答的問題:你能談談4月的事前授權(prior auth)核准率嗎?我只是想了解,如果前兩個月是50%而最後落在46%,我想這意味著3月可能是30%後段;我好奇4月相較於那個事前授權核准率是上升還是下降。

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • Yeah, I don't think March was quite that bad, Frank. There is a little bit of just how many prior offs were being processed in the month of March compared to January and February. We did have a bit of a bolus coming through in the month of January. That help drive that rate a little bit higher.

    是的,Frank,我不認為3月有那麼糟。其中有一點是3月處理的事前授權件數,和1月、2月相比的差異所造成的影響。我們在1月確實有一波較大量的案件進來。那有助於把核准率拉高一些。

  • But as for April, we are seeing it bounce back. But again, we don't have 30-day rates yet for the month of April. All we have is about 11 days worth of data for all of the prior authorizations that were submitted in the month of April at this point in time. What we are seeing in those early rates is seeing a little bit of a bounce back closer to the January-February approval rates than what we saw in the month of March.

    至於4月,我們看到它正在回升。但同樣地,我們目前還沒有4月的30天核准率數據。我們現在只有截至目前為止,4月所提交的所有事前授權申請中,大約11天的數據。從這些早期數據來看,核准率有些回升,更接近1月與2月的核准率,而不是3月的水準。

  • So again, we're expecting this to be a little bit of up and down as we implement new tools and other payers implement new tools to adapt to this new regulation that was issued at the beginning of the year. But we are seeing it bounce back a little bit in the early data for the month of April.

    所以再次強調,隨著我們導入新工具、以及其他付款方也導入新工具以因應年初發布的新規範,我們預期這會有些上下波動。但就4月的早期數據而言,我們確實看到有些回升。

  • Frank Takkinen - Senior Research Analyst

    Frank Takkinen - Senior Research Analyst

  • Got it. Okay. That is helpful. Thank you.

    了解。好的。這很有幫助。謝謝。

  • Operator

    Operator

  • Chase Knickerbocker, Craig-Hallum Capital Group.

    Chase Knickerbocker,Craig-Hallum Capital Group。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Great. Thank you for taking the questions. Maybe just to follow-up on a couple on the dynamic here with Medicare Advantage. Can you just remind us the mix between Part B and Medicare Advantage as far as within your Medicare business?

    很好。謝謝你們接受提問。我想就醫療保險優勢計畫(Medicare Advantage)這邊的動態再追問幾點。能否提醒我們,在你們的醫療保險業務中,Part B 與 Medicare Advantage 的組合占比大概是多少?

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • I think I can take that one, Frank. So the traditional Medicare -- or sorry, Chase, I'm sorry, the traditional Medicare patients represent about a third of our overall patient population, Medicare Advantage patients represent another third. The remaining third of the patient population are private payers, VA, maybe uncovered patients included in that population. So two-thirds are covered by Medicare, but it's split 50-50 traditional Medicare and Medicare Advantage.

    我想這題我可以回答,Frank。所以傳統 Medicare——抱歉,Chase,不好意思——傳統 Medicare 病患約占我們整體病患族群的三分之一,Medicare Advantage 病患另外占三分之一。剩下三分之一的病患族群是商業保險、VA(退伍軍人事務部),也可能包含未投保病患。所以有三分之二由 Medicare 覆蓋,但在傳統 Medicare 與 Medicare Advantage 之間是 50-50 的分布。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • And that reflects your kind of current business mix?

    而這反映的是你們目前的業務組合嗎?

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • Yeah. We're basically in line, if not a little bit heavier weighted towards these Medicare patients.

    是的。我們基本上與此一致,甚至在這些 Medicare 病患上的比重可能還略高一些。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Got it. And just to follow-up on Frank's question. Your guidance assumes that kind of approval rate that you saw in '25. Can you just maybe speak to your comfortability? Is it what you've seen in April as far as kind of that rate in March kind of recovering, or did it really not impact revenue trajectory in March? Just maybe speak to kind of the comfortability around that trend.

    了解。再追問一下 Frank 的問題。你們的指引假設採用你們在 2025 年看到的那種核准率。能否談談你們的信心程度?這是基於你們在 4 月看到的情況(例如 3 月的比率回升),還是 3 月其實並未影響營收走勢?請談談你們對這個趨勢的信心。

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • Yeah, it's the latter, Chase. Yeah, we're feeling good about the guidance that we provided top line. We're at a point where we believe the MA approval rates at 30 days or even the terminal rates are going to be as good or better than what we've seen in 2025, but we want to see this play out a little bit further before we would tighten the range on the guidance.

    是的,是後者,Chase。是的,我們對所提供的營收(top line)指引感覺良好。我們目前認為,MA 在 30 天的核准率,甚至最終核准率,將會與我們在 2025 年看到的一樣好或更好,但在我們收集更多進展之前,還不會收緊指引區間。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Got it. Just the last one for me. As we just think about July approaching and the OPPS proposed rule, have there been any conversations that are notable or any sort of anything you can share as far as any conversations that have happened around your APC placement or any additional thoughts that you guys have there?

    了解。我最後一題。隨著 7 月將近以及 OPPS 擬議規則(proposed rule),是否有任何值得注意的對話,或你們能分享的內容,例如關於你們的 APC 分類(placement)的討論,或你們對此有任何額外想法?

  • Kevin Hykes - President, Chief Executive Officer, Director

    Kevin Hykes - President, Chief Executive Officer, Director

  • Sure. Thanks, Chase. I'll take that one. And it's time for Groundhog Day, I guess, again. The good news is we've been working on this, as we have in past years since January, very constructive engagement with CMS. Our data is better than it's ever been, as is the combined data of this coalition of five companies.

    當然。謝謝,Chase。這題我來回答。我想又到了「土撥鼠日」的時候了。好消息是,我們自 1 月起就一直在推進這件事,和 CMS 的互動非常具建設性,這也和過去幾年的做法一致。我們的數據比以往任何時候都更好,這個由五家公司組成的聯盟的合併數據也是如此。

  • Importantly, all five companies this year are starting in 1,580, which has not been the case in the past. So we think that bodes well for this year's cycle, and we're hopeful that this will be the year that we can finally put this issue to bed. But no specifics right now or commitments, obviously, from CMS, but lots and lots of engagement.

    重要的是,今年五家公司全部都是從 1,580 開始,過去並非如此。因此我們認為這對今年的周期是利多,我們也希望今年終於能把這個議題畫下句點。但目前沒有任何具體內容或來自 CMS 的承諾(顯然),不過互動非常非常頻繁。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Got it. Thank you.

    了解。謝謝。

  • Operator

    Operator

  • Robbie Marcus, JPMorgan.

    Robbie Marcus,JPMorgan。

  • Unidentified Participant

    Unidentified Participant

  • Hi, this is Allen on for Robbie. Thanks for the question. I just had a quick one on your expectations for center adds this year. I think you had previously talked to an average of, say, high single-digit centers per quarter. I think first quarter was relative to our expectations, a little bit on the lower side.

    嗨,我是代替 Robbie 的 Allen。謝謝提問。我有個關於你們今年新增中心(center adds)預期的簡短問題。我記得你們之前提到平均每季大概是高個位數的中心數。我想第一季相較於我們的預期,略偏低一些。

  • But I was curious about the commentary that you had said about the trials potentially bringing in new centers that hadn't historically been CVRx customers. So understanding that the onboarding process for these centers is a longer process, how should we think about that expectation for high-single-digits? Could there be potentially some upside pressure as some of these newer accounts are brought in through the trials rather than maybe your the standard base commercial efforts?

    但我想了解你們提到試驗(trials)可能會帶來一些過去並非 CVRx 客戶的新中心的評論。考量這些中心的導入(onboarding)流程較長,我們該如何看待高個位數的預期?若部分新客戶是透過試驗導入,而不是你們標準的商業拓展,是否可能帶來一些上行壓力?

  • Jared Oasheim - Chief Financial Officer

    Jared Oasheim - Chief Financial Officer

  • Hi, Allen, happy to take that question. Thank you. So our expectation is that the vast majority of the centers that will be activated in BENEFIT-HF will have experience with Barostim already. So we don't believe that this is going to be a significant driver to the new center adds near term. Over time, as we engage some of those new centers and they start to treat patients, they will be included in the active implanting center totals.

    嗨,Allen,我很樂意回答這個問題。謝謝。我們的預期是,將在 BENEFIT-HF 中啟用的中心絕大多數都已經有 Barostim 的使用經驗。因此我們不認為這會在短期內成為新增中心數的重大驅動因素。隨著時間推進,當我們與部分新中心互動、他們開始治療病患後,這些中心會被納入活躍植入中心(active implanting center)的總數中。

  • But I don't think that that's going to have an impact over the next few quarters throughout 2026. As far as expectations go for the new center ads on a quarterly basis, we are still setting the expectation for high single-digits on a net basis on a quarter to quarter, but we may see some variability like we did in the first quarter where we were plus five here in the first quarter. So maybe one quarter we get to low double-digits, other quarters, we're hovering around five or six new center ads on a quarterly basis.

    但我不認為這會在接下來幾季、直到 2026 年期間造成影響。至於每季新增中心數的預期,我們仍以淨新增(net basis)每季高個位數為目標,但可能會像第一季一樣出現一些波動;第一季我們是淨增加 5 家。所以可能某一季會到低雙位數,其他季度則大概在每季新增 5 或 6 家左右。

  • Robbie Marcus - Analyst

    Robbie Marcus - Analyst

  • Got it. And then just a quick follow-up on the Medicare Advantage dynamic. When we think about having to have your market access team appeal these decisions and in light of your, I think, reiterated operating expense guidance, is there a chance -- does this factor in potentially having to expand that team to have to address this higher rate of denials, potentially investment more to make sure that you are continuing to go on the offensive while also addressing these denials? Or is that something that you don't think is something you think you can handle with your current team as is?

    了解。再就 Medicare Advantage 的動態快速追問一下。當我們想到你們需要市場准入團隊(market access team)去申訴這些決定,並且考量你們(我想)重申的營運費用指引,是否有可能——這是否已納入你們可能需要擴編團隊以因應更高拒賠率、可能增加投資以確保你們持續主動出擊同時處理拒賠?或者你們認為以目前團隊就能應付,不需要擴編?

  • Kevin Hykes - President, Chief Executive Officer, Director

    Kevin Hykes - President, Chief Executive Officer, Director

  • Yeah. Thanks, Allen. That's a great question. The short answer is no, we do not. We are deploying AI to respond to AI in effect. And so we don't believe that our team will be any less efficient or that the burden on them will change dramatically. We're sort of responding to a new tool or trick that's being deployed against us, and we're confident we can respond appropriately and that that team can continue to support prior auths in roughly the same with the same efficiency that they have historically.

    是的。謝謝,Allen。這是個很好的問題。簡短答案是不會,我們不會。我們正在部署 AI 來回應 AI,某種程度上是如此。因此我們不認為團隊效率會降低,或他們的負擔會出現顯著變化。我們是在回應一個對我們採用的新工具或新手法,我們有信心能妥善應對,而該團隊也能以大致相同、且與過往一致的效率持續支援事前授權(prior auths)。

  • Operator

    Operator

  • This concludes the question-and-answer session. I would like to turn the floor back over to Kevin Hykes for closing comments.

    問答環節到此結束。我想把時間交回給 Kevin Hykes 作結語。

  • Kevin Hykes - President, Chief Executive Officer, Director

    Kevin Hykes - President, Chief Executive Officer, Director

  • Thank you, operator, and thanks to everyone for joining us today. We appreciate your continued support and look forward to updating you on our progress next quarter. Thank you.

    謝謝,接線員,也謝謝各位今天加入我們。我們感謝各位持續的支持,並期待在下個季度向各位更新我們的進展。謝謝。

  • Operator

    Operator

  • This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

    今天的電話會議到此結束。您現在可以掛斷電話線。感謝您的參與。