Nevro Corp (NVRO) 2022 Q4 法說會逐字稿

Good afternoon. My name is Brent, and I will be your conference operator today. At this time, I would like to welcome everyone to Nevro's Fourth Quarter 2022 Financial Results Conference Call. (Operator Instructions) Thank you.

下午好。我叫布倫特，今天我將擔任你們的會議接線員。此時，我想歡迎大家參加 Nevro 2022 年第四季度財務業績電話會議。 （操作員說明）謝謝。

I would now like to turn the call over to Julie Dewey for introductory remarks. Please go ahead.

我現在想把電話轉給 Julie Dewey 做介紹性發言。請繼續。

Good afternoon, and welcome to Nevro's fourth quarter and full year 2022 earnings conference call. We appreciate you joining us. I'm Julie Dewey, Nevro's Chief Corporate Communications and IR Officer. With me today are Keith Grossman, Chairman, CEO and President; and Rod MacLeod, Chief Financial Officer.

下午好，歡迎來到 Nevro 的第四季度和 2022 年全年收益電話會議。感謝您加入我們。我是 Nevro 的首席企業傳播和 IR 官 Julie Dewey。今天和我在一起的有董事長、首席執行官兼總裁 Keith Grossman；和首席財務官 Rod MacLeod。

The format of our call today will be a discussion of fourth quarter business results from Keith, followed by detailed financials and guidance from Rod, and then we'll open up the call for question. Please note, there are also slides available related to our fourth quarter performance on the Nevro Investor Relations website on the Events and Presentations page.

我們今天電話會議的形式將是討論 Keith 的第四季度業務結果，然後是 Rod 的詳細財務和指導，然後我們將開始提問。請注意，在 Nevro 投資者關係網站的活動和演示頁面上，還有與我們第四季度業績相關的幻燈片。

Earlier today, Nevro released its financial results for the fourth quarter ended December 31st, 2022. A copy of our earnings release is available on our IR section of our website at nevro.com. This call is being broadcast live over the Internet to all interested parties on February 16, 2023, and an archived copy of this webcast will be available on our IR website.

今天早些時候，Nevro 發布了截至 2022 年 12 月 31 日的第四季度財務業績。我們的收益發布副本可在我們網站 nevro.com 的 IR 部分獲取。該電話會議將於 2023 年 2 月 16 日通過互聯網向所有感興趣的各方直播，我們的 IR 網站上將提供該網絡廣播的存檔副本。

Before we begin, I'd like to remind everyone that comments made on today's call may include forward-looking statements within the meaning of federal securities laws. Our results could differ materially from these expressed or implied as a result of certain risks and uncertainties. Please refer to our SEC filings, including our Annual Report on Form 10-K to be filed, for a detailed presentation of risks. The forward-looking statements in this call speak only as of today, and we undertake no obligation to update or revise any of these statements.

在我們開始之前，我想提醒大家，在今天的電話會議上發表的評論可能包括聯邦證券法意義上的前瞻性陳述。由於某些風險和不確定性，我們的結果可能與這些明示或暗示的結果存在重大差異。請參閱我們向美國證券交易委員會提交的文件，包括我們將提交的 10-K 表格年度報告，以詳細介紹風險。本次電話會議中的前瞻性陳述僅適用於今天，我們不承擔更新或修改任何此類陳述的義務。

In addition, we will refer to adjusted EBITDA, which is a non-GAAP measure that is used to help investors understand Nevro's ongoing business performance. Non-GAAP adjusted EBITDA excludes certain litigation related expenses and credits, interest, taxes and noncash items such as stock-based compensation and depreciation and amortization. Please refer to the GAAP to non-GAAP reconciliation tables within our release.

此外，我們將參考調整後的 EBITDA，這是一種非 GAAP 衡量標準，用於幫助投資者了解 Nevro 的持續經營業績。非 GAAP 調整後 EBITDA 不包括某些與訴訟相關的費用和信貸、利息、稅收和非現金項目，例如基於股票的補償和折舊及攤銷。請參閱我們發布的 GAAP 與非 GAAP 調節表。

And now it's my pleasure to turn the call over to Keith.

現在我很高興將電話轉給基思。

Thank you, Julie, and good afternoon, everyone, and thank you for joining us. I'm going to focus my comments today on our fourth quarter results, the current state of our business and recovery, the progress of our PDN launch, and the limited market release of our new HFX iQ system. Now, following my comments, Rod will cover the specifics of our Q4 results and our '23 first quarter and full year guidance.

謝謝你，朱莉，大家下午好，感謝你加入我們。我今天的評論重點是我們的第四季度業績、我們的業務和復甦的現狀、我們 PDN 發布的進展，以及我們新的 HFX iQ 系統的有限市場發布。現在，根據我的評論，Rod 將介紹我們第四季度業績的細節以及我們的 23 年第一季度和全年指導。

Overall, we continue to move our business forward in Q4, and we're entering '23 with I think some real positive momentum. Our revenue was at the high end of our guidance. U.S. procedure growth rates grew double digits and adjusted EBITDA results were within our guidance range, excluding onetime charges.

總的來說，我們在第四季度繼續推動我們的業務向前發展，我們正在進入 23 世紀，我認為有一些真正的積極勢頭。我們的收入處於我們指導的高端。美國程序增長率增長了兩位數，調整後的 EBITDA 結果在我們的指導範圍內，不包括一次性費用。

I'm really pleased with the building blocks that are now in place for attractive growth and leverage going forward and believe the challenges to our market will gradually but steadily continue to improve throughout '23 and beyond. There were a number of encouraging elements of our progress in the fourth quarter. Global revenue growth was 12% over prior year on a constant currency basis, while U.S. revenue growth came in at 13% and U.S. trial activity delivered 9% year-over-year growth. In fact, October, November, and December were all-time record months for daily trial rates in the U.S. with Q4 U.S. trials, in fact, about 6% ahead of 2019, which, of course, was our last pre-COVID comparable period.

我對現在為有吸引力的增長和槓桿作用而建立的基石感到非常高興，並相信我們市場面臨的挑戰將在整個 23 世紀及以後逐漸但穩步地繼續改善。我們在第四季度取得的進展有許多令人鼓舞的因素。按固定匯率計算，全球收入同比增長 12%，而美國收入增長 13%，美國試驗活動同比增長 9%。事實上，10 月、11 月和 12 月是美國每日試驗率的歷史最高月份，美國第四季度的試驗實際上比 2019 年提前了約 6%，當然，這是我們在 COVID 之前的最後一個可比時期.

Based on reported competitive revenues thus far for Q4, we continued to gain market share in the quarter and full year '22 as well. PDN continues to be a significant driver of growth with impressive performance quarter over quarter throughout 2022. And finally, our new AI-powered HFX iQ system is performing really well in our limited market release with positive feedback from physicians and patients regarding the ability to deliver personalized pain relief using our big data backed HFX Algorithm. And more on iQ later in my remarks. But I think this technology really has the opportunity to further differentiate our competitive position in this space.

根據迄今為止報告的第 4 季度有競爭力的收入，我們在本季度和 22 年全年也繼續獲得市場份額。 PDN 將繼續成為增長的重要推動力，在整個 2022 年每個季度都有令人印象深刻的表現。最後，我們新的 AI 驅動的 HFX iQ 系統在我們有限的市場發布中表現非常好，醫生和患者對提供能力的積極反饋使用我們的大數據支持的 HFX 算法進行個性化止痛。稍後在我的評論中還有更多關於 iQ 的內容。但我認為這項技術確實有機會進一步區分我們在這個領域的競爭地位。

All of this progress builds, of course, on our superior high-frequency paresthesia-free SCS technology, and we're confident that we're well positioned for '23. We see continued signs of market recovery as the recent challenges in our market are beginning to recede, and we continue to believe that the underlying fundamentals of the addressable market and the opportunity for growth remain largely intact. We continue to see encouraging growth in trials and permanent implants. And we're starting to see the recovery that we expected to see as the impacts of the pandemic begin to wane.

當然，所有這些進步都建立在我們卓越的高頻無感覺異常 SCS 技術之上，我們相信我們已經為 23 年做好了準備。隨著我們市場近期的挑戰開始消退，我們看到市場復甦的持續跡象，我們仍然相信潛在市場的基本面和增長機會基本完好。我們繼續看到試驗和永久植入物的令人鼓舞的增長。隨著大流行的影響開始減弱，我們開始看到我們預期會看到的複蘇。

We think, by the way, that that is going to continue throughout '23, though we know it's likely -- though it's unlikely, rather, to be linear in nature. Of course, lingering staffing challenges and capacity congestion do continue to put pressure on the scheduling of procedures, but these also seemed to improve a little during the fourth quarter, and we believe this trend will continue throughout '23 as well. Our guidance takes this into account and implies year-over-year revenue growth for the first quarter of 9% to 11% on a constant currency basis. Of course, this assumes the typical sequential seasonality we usually see from Q4 to Q1. Our previous research indicated that patient engagement with pain specialists has been improving and as the market's capacity to handle pre-COVID volumes is more fully restored, we expect to see market growth return over time to historical CAGRs.

順便說一句，我們認為這將在整個 23 年持續下去，儘管我們知道這很可能——儘管它不太可能在本質上是線性的。當然，揮之不去的人員配置挑戰和產能擁堵確實繼續給程序的安排帶來壓力，但這些在第四季度似乎也有所改善，我們相信這種趨勢也將在整個 23 年持續下去。我們的指引考慮到了這一點，並暗示在固定匯率基礎上第一季度收入同比增長 9% 至 11%。當然，這是假設我們通常從 Q4 到 Q1 看到的典型連續季節性。我們之前的研究表明，患者與疼痛專家的接觸一直在改善，隨著市場處理 COVID 前數量的能力得到更充分的恢復，我們預計隨著時間的推移，市場增長將恢復到歷史 CAGR。

Turning now to our PDN business. Our progress with referring clinicians, payers, and the clinical societies exceeded our expectations in 2022, and we're looking forward to continuing to develop this exciting growth platform in 2023. During the quarter, PDN trials represented approximately 20% of our total U.S. trial volume. That's up from 18% of our total U.S. trial volume in Q3 and that actually improved throughout the course of the quarter. Among our permanent implant procedures, PDN represented around 16% of the total worldwide procedures, resulting in approximately $17.3 million in PDN indication sales. And that's an increase of 29% sequentially compared to $13.4 million in the third quarter, which we attributed in the large measure to the PDN referral sales organization expansion that was completed in June as well as our outreach initiatives with both physicians and patients.

現在轉向我們的 PDN 業務。我們在 2022 年與轉診臨床醫生、付款人和臨床協會的進展超出了我們的預期，我們期待在 2023 年繼續開發這個令人興奮的增長平台。在本季度，PDN 試驗約占我們美國試驗總數的 20%體積。這高於我們第三季度美國總試用量的 18%，並且在整個季度中實際上有所改善。在我們的永久植入手術中，PDN 約佔全球手術總數的 16%，導致 PDN 適應症銷售額約為 1730 萬美元。與第三季度的 1340 萬美元相比，環比增長了 29%，這在很大程度上歸因於 6 月份完成的 PDN 轉診銷售組織擴張以及我們與醫生和患者的外展計劃。

In the month of December, approximately, 16% of our U.S. PDN trial procedures came from leads generated by our own DTC programs. And we continue to test new direct-to-patient media channels and programs to drive awareness and interest with patients directly. In addition to the existing payer coverage policies in place for PDN, we continue to see a high level of case-by-case approvals through the prior authorization process and the appeal of payer denials, including with payers who don't have a [physician] or rather a positive PDN coverage policy. For those PDN cases that have come through our own access group, our cumulative approval rate as of the end of December continued to trend around 80% and that was up from about 62% at the end of 2021.

在 12 月，大約 16% 的美國 PDN 試驗程序來自我們自己的 DTC 程序產生的線索。我們繼續測試新的直接面向患者的媒體渠道和計劃，以直接提高患者的意識和興趣。除了針對 PDN 的現有付款人覆蓋政策外，我們繼續看到通過事先授權流程和付款人拒絕的上訴獲得高水平的個案批准，包括沒有[醫生]的付款人] 或者更確切地說是積極的 PDN 覆蓋政策。對於那些通過我們自己的訪問組的 PDN 案例，截至 12 月底，我們的累計批准率繼續保持在 80% 左右的趨勢，高於 2021 年底的約 62%。

Finally, the complete 24-month PDN RCT trial data and the 12-month Quality of Life RCT data were presented in January at the NANS Conference in 2 separate podium presentations by Dr. Erika Petersen. These strong results confirmed the long-term durability of pain relief as well as clinically meaningful improvement in neurological function and quality of life achieved with 10 kilohertz therapy. We expect to submit this data in the coming months for publication.

最後，完整的 24 個月 PDN RCT 試驗數據和 12 個月生活質量 RCT 數據在 1 月份的 NANS 會議上由 Erika Petersen 博士在 2 個獨立的講台上發表。這些強有力的結果證實了 10 赫茲療法能夠長期持久地緩解疼痛，並在神經功能和生活質量方面實現具有臨床意義的改善。我們希望在未來幾個月內提交這些數據以供發布。

In addition, we're also looking forward to enrolling our first patient next quarter in our new PDN sensory study, which will be the first prospective RCT specifically powered to assess restoration of neurological function as a primary endpoint in patients with intractable PDN. We plan to enroll up to 236 patients at multiple sites across the U.S. Patients will be randomized to conventional medical management or 10 kilohertz SCS plus conventional medical management, with optional crossover to the other treatment arm at 6 months if those criteria are met.

此外，我們還期待下個季度在我們新的 PDN 感覺研究中招募第一位患者，這將是第一個專門用於評估神經功能恢復作為難治性 PDN 患者主要終點的前瞻性隨機對照試驗。我們計劃在美國多個地點招募多達 236 名患者。患者將被隨機分配接受常規醫療管理或 10 赫茲 SCS 加常規醫療管理，如果滿足這些標準，則可選擇在 6 個月時交叉到另一個治療組。

This sensory study is groundbreaking really for several reasons. Diabetes and peripheral neuropathy pose a staggering socioeconomic burden. There is no available disease-modifying treatment option available for patients with PDN. In fact, every 20 seconds in the U.S., there is a diabetes-related amputation, according to the American Limb Preservation Society, and many of these amputations are preventable. Insensate or numb feet contribute to unrecognized injuries and foot ulcers as patients lack protective sensation. Foot ulcer treatment and associated amputation surgeries are costly, both economically and, of course, psychosocially. By restoring sensation in the feet, 10 kHz SCS may alleviate this tremendous disease burden, prevent amputations, and enable patients to be more active, all of which would improve overall health and quality of life and, of course, reduce healthcare costs.

由於幾個原因，這項感官研究確實具有開創性。糖尿病和周圍神經病變造成了驚人的社會經濟負擔。目前還沒有適用於 PDN 患者的疾病緩解治療方案。事實上，根據美國肢體保護協會的數據，在美國每 20 秒就有一例與糖尿病相關的截肢，其中許多截肢是可以預防的。由於患者缺乏保護性感覺，無感覺或麻木的腳會導致無法識別的損傷和足部潰瘍。足部潰瘍治療和相關的截肢手術在經濟上和社會心理上都是昂貴的。通過恢復腳部的感覺，10 kHz SCS 可以減輕這種巨大的疾病負擔，防止截肢，並使患者更加活躍，所有這些都將改善整體健康和生活質量，當然還會降低醫療保健成本。

This study also affords a path forward to building clinical evidence for slowing the progression of or improving sensory loss of lower limbs in patients with chronic intractable pain and builds on the significant outcomes we saw in our landmark 10 kilohertz SCS RCT with powered study endpoints targeting the disease-modifying benefits of improved neurological function and pain relief. And you'll recall that the observed neurological improvements we saw in the original SENZA-PDN study are unique to 10 kHz SCS and have not been reported for any other competitive SCS modality. Not only do we anticipate that this study will provide additional confirmatory evidence of the benefits of Nevro's proprietary 10 kHz therapy in these PDN patients, but we also believe that the additional Level 1 data generated will be very helpful as we continue to work with payers to expand PDN coverage generally.

這項研究還為建立臨床證據以減緩慢性頑固性疼痛患者下肢感覺喪失的進展或改善其感覺喪失提供了一條途徑，並以我們在具有里程碑意義的 10 赫茲 SCS RCT 中看到的顯著結果為基礎，該研究終點針對改善神經功能和緩解疼痛的疾病緩解益處。您會記得，我們在最初的 SENZA-PDN 研究中看到的觀察到的神經學改善是 10 kHz SCS 獨有的，並且尚未報告任何其他競爭性 SCS 模式。我們不僅預計這項研究將提供更多證實性證據證明 Nevro 專有的 10 kHz 療法對這些 PDN 患者的益處，而且我們還相信，隨著我們繼續與付款人合作，產生的額外 1 級數據將非常有幫助普遍擴大 PDN 覆蓋範圍。

I'm pleased to announce that the FDA has granted breakthrough device designation for the PDN Sensory study and this potential device indication. This designation by the FDA provides for an expedited review for a marketing application to expand Nevro's FDA labeling. And as I said earlier, we look forward to enrolling our first patient next quarter, and we're really excited about the opportunity for this target patient group. Following our strong progress in '22, PDN is expected to be a significant growth driver for us once again this year. As another example of the growing interest in PDN, as of the end of December, over 70% of Nevro-implanting physicians had consulted with 1 or more PDN patients in their practice. Our '23 revenue guidance includes a $75 million to $85 million contribution from PDN. That's an increase of 56% to 77% over '22. As we said, over time we think PDN is going to be one of the more significant parts of spinal cord stimulation, and perhaps growing to as much as 1/3 of the U.S. SCS market.

我很高興地宣布，FDA 已授予 PDN 感官研究和該潛在設備適應症的突破性設備指定。 FDA 的這一指定為擴大 Nevro 的 FDA 標籤的營銷申請提供了加速審查。正如我之前所說，我們期待著在下個季度招募我們的第一位患者，我們對這個目標患者群體的機會感到非常興奮。繼我們在 22 年取得的強勁進展之後，預計 PDN 今年將再次成為我們的重要增長動力。作為對 PDN 日益增長的興趣的另一個例子，截至 12 月底，超過 70% 的 Nevro 植入醫生在他們的實踐中諮詢了一名或更多 PDN 患者。我們的 23 年收入指引包括來自 PDN 的 7500 萬至 8500 萬美元的貢獻。這比 22 年增加了 56% 到 77%。正如我們所說，隨著時間的推移，我們認為 PDN 將成為脊髓刺激中更重要的部分之一，並且可能增長到美國 SCS 市場的 1/3。

Our guidance for '23 implies this patient segment will already be about 15% to 20% of our own business in just its second full year. Moving now to nonsurgical back pain. After receiving FDA approval of this indication last January, we began commercial activities to expand access to HFX therapy for this patient population by focusing on the identification and education of patients already at existing pain practices who have not had prior surgery and who are not a candidate for surgery. Unlike PDN, we've always viewed the NSBP patient population as sort of a rising tide for the entire SCS industry and pain specialty. We continue to lead the charge in generating NSBP clinical data, but it was encouraging to see our competitors also begin to report their own data at NANS this year, which helps to build the foundation of clinical evidence supporting this indication. As our competitors continue to join us in the generation of NSBP data, we believe more payers will continue to cover SCS therapy for these patients who have exhausted all other options for which they're candidates. We believe this will help to grow the market for SCS therapy for back and leg pain patients in the coming years.

我們對 23 年的指導意味著，僅在其第二個完整年度，該患者部分就已經占我們自身業務的 15% 至 20%。現在轉向非手術背痛。在去年 1 月獲得 FDA 對該適應症的批准後，我們開始開展商業活動，通過重點識別和教育已經接受現有疼痛治療但既往未接受過手術且不是候選者的患者，擴大該患者群體獲得 HFX 治療的機會用於手術。與 PDN 不同，我們一直將 NSBP 患者群體視為整個 SCS 行業和疼痛專業的上升趨勢。我們繼續帶頭生成 NSBP 臨床數據，但令人鼓舞的是，看到我們的競爭對手今年也開始在 NANS 上報告他們自己的數據，這有助於為支持該適應症的臨床證據奠定基礎。隨著我們的競爭對手繼續加入我們生成 NSBP 數據的行列，我們相信更多的付款人將繼續為這些已經用盡所有其他選擇的患者提供 SCS 治療。我們相信，這將有助於在未來幾年發展用於背部和腿部疼痛患者的 SCS 治療市場。

Speaking of that, our clinical investigators presented positive 2-year follow-up data for our SENZA-NSBP trial at NANS, which included clinically important and stable pain relief in patients treated with 10 kHz SCS as well as strong durable improvement in reported function and a significant quality-of-life improvement. These results were seen in patients with refractory chronic low-back pain who were evaluated by a spine surgeon for surgical candidacy and who had exhausted all appropriate nonoperative medical management.

說到這一點，我們的臨床研究人員為我們在 NANS 進行的 SENZA-NSBP 試驗提供了積極的 2 年隨訪數據，其中包括在接受 10 kHz SCS 治療的患者中具有臨床意義且穩定的疼痛緩解以及報告的功能和功能的持久改善顯著改善生活質量。這些結果見於難治性慢性腰痛患者，這些患者由脊柱外科醫生評估是否適合手術，並且已經用盡了所有適當的非手術治療方法。

On the reimbursement front, to date, we've not experienced any noticeable impact on our revenue from UnitedHealthcare's decision to exclude coverage for NSBP patients, which became effective on December 1. We also don't expect this coverage decision to have a material impact on our go-forward revenue opportunity as we said previously. And we believe our continued generation of high-quality clinical evidence will ultimately carry the day, just as it has thus far with the PDN indication.

在報銷方面，到目前為止，UnitedHealthcare 決定排除 NSBP 患者的承保範圍對我們的收入沒有任何明顯影響，該決定於 12 月 1 日生效。我們也不認為這一承保決定會產生實質性影響正如我們之前所說，關於我們未來的收入機會。我們相信，我們不斷產生的高質量臨床證據最終將取得成功，就像迄今為止在 PDN 適應症方面所做的那樣。

Now I'd like to turn to our new Senza HFX iQ system. Following FDA approval last quarter, we initiated a limited U.S. market release, which has been very well received. iQ is the first big data-backed, AI-powered spinal cord stimulation system that gets smarter over time by learning from each patient's pain experience and that patient's interaction with the device and the therapy. iQ is powered by something no other SCS system has, big data. In fact, over a decade of longitudinal patient data from our HFX Cloud patient database. Our HFX Algorithm, which is based on over 20 million clinical data points from over 80,000 patients in this database, drives the iQ product. This algorithm starts patients on the stimulation program most likely to provide relief based on their specific profile. iQ is Bluetooth enabled and connected to a patient app and learns each patient's individual inputs to personalized therapy recommendations designed to progress the patient along their pain relief journey. This combination of big data, AI, and direct patient engagement and input is intended to optimize and maintain pain relief on an individualized basis, giving patients more control over their pain relief based on their personal experience and at a time that suits them.

現在我想談談我們新的 Senza HFX iQ 系統。在上個季度獲得 FDA 批准後，我們啟動了有限的美國市場發布，受到了廣泛好評。 iQ 是第一個由大數據支持、人工智能驅動的脊髓刺激系統，它通過從每位患者的疼痛經歷以及患者與設備和治療的互動中學習，隨著時間的推移變得更加智能。 iQ 由其他 SCS 系統所沒有的大數據提供支持。事實上，我們的 HFX Cloud 患者數據庫中有超過十年的縱向患者數據。我們的 HFX 算法基於該數據庫中來自 80,000 多名患者的超過 2000 萬個臨床數據點，驅動 iQ 產品。該算法使患者開始接受最有可能根據其特定情況提供緩解的刺激計劃。 iQ 支持藍牙並連接到患者應用程序，並了解每個患者的個人輸入以提供個性化治療建議，旨在使患者在緩解疼痛的過程中取得進步。這種大數據、人工智能和患者直接參與和輸入的結合旨在在個性化的基礎上優化和維持疼痛緩解，讓患者根據自己的個人經驗在適合自己的時間更好地控制疼痛緩解。

IQ is a powerful supplement to our field team, our HFX coaches, and our cloud database that provides physicians with both detailed and summary outcomes data. We believe the iQ will lessen the burden on our patients and our customers and expect this launch to support our growth prospects in '23 and well beyond. By the way, the iQ product line is the next logical step in allowing us to drive more profitable growth as it enables our existing team to scale more effectively over a larger base of patients and revenue going forward. I believe this, combined with the ramp-up of our Costa Rica manufacturing facility, is really going to help us with the earnings productivity of our revenue growth in the coming years. At the NANS meeting, we had an opportunity to feature the HFX iQ system at our exhibit booth and several other events, including a well-attended physician education launch. We're preparing for a full U.S. launch very soon and expect a meaningful shift in mix to the HFX iQ product throughout the rest of the year.

IQ 是對我們的現場團隊、我們的 HFX 教練和我們的雲數據庫的有力補充，為醫生提供詳細和摘要結果數據。我們相信 iQ 將減輕我們患者和客戶的負擔，並期望此次發布能夠支持我們在 23 世紀及以後的增長前景。順便說一句，iQ 產品線是使我們能夠推動更多利潤增長的下一個合乎邏輯的步驟，因為它使我們現有的團隊能夠更有效地擴展到更大的患者群和未來的收入。我相信，這與我們哥斯達黎加製造工廠的擴大相結合，將真正幫助我們提高未來幾年收入增長的盈利生產力。在 NANS 會議上，我們有機會在我們的展台和其他幾項活動中展示 HFX iQ 系統，包括參加人數眾多的醫師教育發布會。我們正在為很快在美國全面推出做準備，並預計在今年餘下的時間裡，HFX iQ 產品的組合將發生有意義的轉變。

In addition to the U.S. approval for iQ, we've already submitted for approval in Europe and Australia. In summary, the HFX iQ reflects our continued commitment to deliver comprehensive life-changing solutions for patients with chronic pain, and it comes at an exciting time as we've now impacted the lives of more than 100,000 implanted patients globally with our technology. We think what we're doing with the iQ represents the future of SCS therapy, and it keeps Nevro firmly at the forefront of innovation as we continue to bring new technology, new data, and new indications to our customers and our patients. We're also very proud to announce that we recently received our certification to the new European regulatory standard for medical device companies known as EUMDR. This certification is a strong validation of the strength of our internal quality management system, and it follows several years of work and preparation by our team. I should mention that only about 25% of the applications received by European notified bodies have undergone regulatory assessment and received a certificate according to this new and more robust regulatory framework. And I'm really pleased that Nevro is among the first wave of medical device companies to achieve certification to this new standard.

除了美國對 iQ 的批准外，我們已經提交了歐洲和澳大利亞的批准。總而言之，HFX iQ 反映了我們為慢性疼痛患者提供全面改變生活的解決方案的持續承諾，它出現在一個激動人心的時刻，因為我們現在已經用我們的技術影響了全球超過 100,000 名植入患者的生活。我們認為我們對 iQ 所做的工作代表了 SCS 治療的未來，它使 Nevro 在我們繼續為我們的客戶和患者帶來新技術、新數據和新適應症時堅定地處於創新的前沿。我們還非常自豪地宣布，我們最近獲得了針對醫療設備公司的新歐洲監管標準（稱為 EUMDR）的認證。該認證是對我們內部質量管理體系實力的有力驗證，是我們團隊多年工作和準備的結果。我應該提一下，歐洲公告機構收到的申請中只有約 25% 根據這個新的、更強大的監管框架進行了監管評估並獲得了證書。我真的很高興 Nevro 是第一批獲得這一新標準認證的醫療設備公司之一。

So, in closing, we made encouraging progress in the fourth quarter with what we believe will be continued recovery in our markets, important new products like the HFX iQ platform, entirely new patient populations like PDN and NSBP, and the opportunity for attractive operating leverage on future growth as a result of our intense focus on the scalability of our expense structure, I think the outlook for Nevro is increasingly bright.

因此，最後，我們在第四季度取得了令人鼓舞的進展，我們相信我們的市場將持續復甦，HFX iQ 平台等重要的新產品，PDN 和 NSBP 等全新的患者群體，以及有吸引力的經營槓桿的機會關於由於我們高度關注費用結構的可擴展性而導致的未來增長，我認為 Nevro 的前景越來越光明。

And with that, I'll pass the call over to Rod to provide further details on our fourth quarter results and on our guidance.

有了這個，我會把電話轉給羅德，提供有關我們第四季度業績和指導的更多細節。

Thanks, Keith, and good afternoon. I'll begin with our worldwide revenue for the fourth quarter of 2022 which was $113.8 million, an increase of 11% as reported and 12% on a constant currency basis, compared to $102.8 million in the fourth quarter of 2021. PDN represented 16% of worldwide permanent implant procedures, which resulted in approximately $17.3 million in PDN indication sales in the fourth quarter of 2022. As a reminder, this quarter included one less selling day in Q4 of 2021. U.S. revenue in the fourth quarter of 2022 is $99.8 million, an increase of 13% compared to $88.4 million in the fourth quarter of 2021. International revenue was $14.1 million, a decrease of 2% as reported, but an increase of 9% constant currency compared to $14.3 million in the fourth quarter of 2021.

謝謝，基思，下午好。我將從我們 2022 年第四季度的全球收入為 1.138 億美元開始，與 2021 年第四季度的 1.028 億美元相比，報告增長 11%，按固定匯率計算增長 12%。PDN 佔 16%全球永久性植入手術，導致 2022 年第四季度 PDN 適應症銷售額約為 1730 萬美元。提醒一下，本季度包括 2021 年第四季度的銷售日減少。2022 年第四季度美國收入為 9980 萬美元，與 2021 年第四季度的 8840 萬美元相比增長了 13%。國際收入為 1410 萬美元，據報導下降了 2%，但與 2021 年第四季度的 1430 萬美元相比增長了 9%。

Now moving on to some detail below the top line. Gross profit for the fourth quarter of 2022 was $75.2 million, an increase of 9% compared to $69.1 million in the fourth quarter of 2021. Gross margin was 66.1% in the fourth quarter of '22 compared to 67.3% in the fourth quarter of 2021. As Keith said, the limited market release of the HFX iQ system continues to progress well, and the company continues to anticipate a full market launch very soon with a meaningful shift in mix to the HFX iQ product following the full market launch. As a result, we recognized charges to cost of goods sold in the fourth quarter of '22 of approximately $2 million related to the write-off of a portion of our legacy product inventory. Without these charges, margins would have been 68%.

現在轉到頂行下方的一些細節。 2022 年第四季度的毛利潤為 7520 萬美元，與 2021 年第四季度的 6910 萬美元相比增長了 9%。2022 年第四季度的毛利率為 66.1%，而 2021 年第四季度為 67.3% . 正如 Keith 所說，HFX iQ 系統的有限市場發布繼續進展順利，公司繼續預計很快將全面上市，並在全面上市後向 HFX iQ 產品進行有意義的組合轉變。因此，我們在 2022 年第四季度確認了與註銷部分遺留產品庫存相關的約 200 萬美元的銷售成本費用。如果沒有這些費用，利潤率將達到 68%。

Operating expenses for the fourth quarter of 2022 were $94.6 million, down 1% compared to $95.3 million in the fourth quarter of 2021 and, in fact, were up less than 2% over the fourth quarter of 2019. Litigation-related legal expenses were $1.2 million for the fourth quarter of '22 compared to a $6.1 million in the fourth quarter of 2021. The company also incurred restructuring charges of approximately $700,000 in the fourth quarter of 2022 and expects to incur an additional approximate $300,000 of restructuring charges in the first quarter of 2023. Net loss from operations for the fourth quarter of '22 was $19.4 million compared to a loss of $26.2 million in the fourth quarter of 2021. Non-GAAP adjusted EBITDA for the fourth quarter of '22 was a loss of $1.4 million compared to a loss of $7.5 million in the fourth quarter of 2021. Without the $2 million inventory charge, adjusted EBITDA would have finished at a positive $600,000 for the quarter. Cash, cash equivalents, and short-term investments totaled $374.4 million as of December 31st, 2022. This represents a decrease during the fourth quarter of '22 of $12.5 million. We continue to manage our working capital and are very comfortable with our balance sheet to fund operations.

2022 年第四季度的運營費用為 9460 萬美元，與 2021 年第四季度的 9530 萬美元相比下降了 1%，實際上比 2019 年第四季度增長了不到 2%。與訴訟相關的法律費用為 1.2 美元22 年第四季度為 610 萬美元，而 2021 年第四季度為 610 萬美元。該公司還在 2022 年第四季度產生了約 700,000 美元的重組費用，並預計在第一季度額外產生約 300,000 美元的重組費用2023 年第四季度的運營淨虧損為 1940 萬美元，而 2021 年第四季度為虧損 2620 萬美元。2022 年第四季度的非公認會計原則調整後 EBITDA 為虧損 140 萬美元，相比之下到 2021 年第四季度虧損 750 萬美元。如果沒有 200 萬美元的庫存費用，調整後的 EBITDA 本季度將達到正值 600,000 美元。截至 2022 年 12 月 31 日，現金、現金等價物和短期投資總計 3.744 億美元。這比 22 年第四季度減少了 1250 萬美元。我們繼續管理我們的營運資金，並對我們的資產負債表為運營提供資金感到非常滿意。

Turning now to guidance. It's important to note that we will be using non-GAAP financial measures to describe our outlook for the business. Please see the financial tables in our press release issued today for GAAP to non-GAAP reconciliations. Keep in mind is the guidance that we are providing today assumes that full year of 2023 will see steady improvement in provider capacity due primarily to a decrease in healthcare facility staffing challenges as well as no changes in macroeconomic factors that would materially impact a patient's willingness or ability to seek elective care. The trial-to-perm conversion curve has improved just slightly, but it is still a bit slower than historical norms. In Q4, despite the slight improvement, we saw small impact due to this lengthened trial-to-perm curve relative to historical norms. Our guidance assumes that this trial-to-perm curve remains at current levels for the balance of the year and doesn't improve or worsen.

現在轉向指導。重要的是要注意，我們將使用非 GAAP 財務指標來描述我們的業務前景。請參閱我們今天發布的新聞稿中的財務表格，了解 GAAP 與非 GAAP 對賬。請記住，我們今天提供的指導假設 2023 年全年供應商能力將穩步提高，這主要是由於醫療機構人員配置挑戰的減少以及宏觀經濟因素沒有變化會嚴重影響患者的意願或尋求選擇性護理的能力。從試用到燙髮的轉換曲線略有改善，但仍比歷史標準慢一些。在第 4 季度，儘管略有改善，但由於相對於歷史規範的這種延長的試用-燙髮曲線，我們看到了很小的影響。我們的指導假設這條從試用到燙髮的曲線在今年餘下時間保持在當前水平，既沒有改善也沒有惡化。

Given this backdrop, we are guiding to first quarter worldwide revenue of approximately $94 million to $96 million, which represents 9% to 11% growth on a constant currency basis and reflects the typical seasonal stepdown in revenue from Q4 to Q1. All of these market factors related to recovery apply equally to PDN case volumes as well, and we expect PDN to reflect similar Q1 seasonality to the larger SCS market. Thus, PDN indication sales in the first quarter of 2023 are expected to be approximately 15% to 20% below the fourth quarter of 2022 and then expected to grow sequentially each quarter for the remainder of 2023, given the strong underlying momentum in this indication. We expect first quarter of 2023 non-GAAP adjusted EBITDA to be a loss of approximately $19 million to $20 million.

鑑於這種背景，我們預計第一季度全球收入約為 9400 萬美元至 9600 萬美元，按固定匯率計算增長 9% 至 11%，反映了從第四季度到第一季度收入的典型季節性下降。所有這些與復蘇相關的市場因素同樣適用於 PDN 案例量，我們預計 PDN 將反映與更大的 SCS 市場類似的第一季度季節性。因此，預計 2023 年第一季度的 PDN 適應症銷售額將比 2022 年第四季度低約 15% 至 20%，然後預計在 2023 年剩餘時間內每個季度都將連續增長，因為該適應症的潛在勢頭強勁。我們預計 2023 年第一季度非 GAAP 調整後的 EBITDA 將虧損約 1900 萬至 2000 萬美元。

As we've seen historically, Q1 experiences a disproportionate amount of annual expenses due to the NANS Conference, our global sales meeting, as well as certain other Q1-heavy expenses such as payroll taxes and 401(k) matching that we set in the new calendar year. This year's Q1 expenses are more in line with our normal Q1 pace as a percent of total spending for the year. They also represent a bigger difference over prior year because of our global sales meeting, robust NANS presence, and increased PDN investment. We do want to point out that current consensus does not reflect this step-up in operating expenses that we normally see in Q1.

正如我們從歷史上看到的那樣，由於 NANS 會議、我們的全球銷售會議以及我們在新的日曆年。今年第一季度的支出佔全年總支出的百分比更符合我們正常的第一季度步伐。由於我們的全球銷售會議、強大的 NANS 存在以及增加的 PDN 投資，它們也比上一年有更大的差異。我們確實想指出，目前的共識並沒有反映出我們通常在第一季度看到的運營費用的增加。

To help you with timing, in the second and third quarters of this year, we expect to be at around breakeven from an adjusted EBITDA perspective and moving toward a positive adjusted EBITDA range in the fourth quarter. We continue to expect worldwide revenue for full year 2023 of approximately $445 million to $455 million, an increase of 10% to 12% over prior year, or 10% to 13% on a constant currency basis. This full year 2023 guidance includes approximately $75 million to $85 million of PDN indication sales, an increase of 56% to 77% over prior year.

為了幫助您把握時機，在今年第二和第三季度，我們預計從調整後的 EBITDA 角度來看將達到盈虧平衡，並在第四季度朝著正的調整後 EBITDA 範圍邁進。我們繼續預計 2023 年全年全球收入約為 4.45 億美元至 4.55 億美元，比上年增長 10% 至 12%，或按固定匯率計算增長 10% 至 13%。這一 2023 年全年指導包括約 7500 萬至 8500 萬美元的 PDN 適應症銷售額，比上年增長 56%至 77%。

For full year 2023, gross margin is expected to be approximately 68%. The Costa Rica manufacturing plant is producing meaningful volumes to date in 2023, and we remain encouraged by the volume potential of production as well as the high quality of and cost reductions in our manufactured products. However, 2023 gross margins will experience some headwinds in the first 3 quarters of the year due to recent pricing increases from some of our contract manufacturers and heavier-than-anticipated 2023 projected mix of contract manufacturer products. We expect to see improvements in gross margins beginning in Q4 and then believe that Costa Rica facility will deliver gross margin expansion to the mid-70% range over the next 3 to 5 years, assuming no material pricing changes.

預計 2023 年全年毛利率約為 68%。到 2023 年為止，哥斯達黎加製造工廠的產量非常可觀，我們仍然對產量潛力以及我們製造的產品的高質量和成本降低感到鼓舞。然而，2023 年的毛利率將在今年前 3 季度遇到一些不利因素，原因是我們的一些合同製造商最近的價格上漲以及 2023 年合同製造商產品的預期組合超出預期。我們預計從第四季度開始毛利率將有所改善，然後相信哥斯達黎加工廠將在未來 3 至 5 年內將毛利率擴大至 70% 左右，假設沒有重大價格變化。

Operating expenses are expected to be approximately $391 million to $393 million for 2023, including combined litigation expenses and ongoing investment in PDN market development of approximately $40 million. We expect full year 2023 non-GAAP adjusted EBITDA to be in the range of negative $5 million to negative $10 million, which compares to a non-GAAP adjusted EBITDA loss of $23.8 million in 2022. We do want to provide you with the expected cadence of our business to assist you in modeling our quarterly performance during 2023. We expect high-single to double-digit constant currency growth for the first half of the year over prior year. The 2 quarters in the back half of the year are expected to grow in mid-teens over Q3 and Q4 of 2022 as we assume we will benefit from an improving market environment, the launch of HFX iQ, and continued progress in our PDN business.

預計 2023 年的運營費用約為 3.91 億美元至 3.93 億美元，其中包括合併訴訟費用和對 PDN 市場開發的持續投資約 4000 萬美元。我們預計 2023 年全年非 GAAP 調整後 EBITDA 將在負 500 萬美元至負 1000 萬美元之間，而 2022 年非 GAAP 調整後 EBITDA 虧損為 2380 萬美元。我們確實希望為您提供預期的節奏我們的業務，以幫助您對我們 2023 年的季度業績進行建模。我們預計今年上半年與上一年相比將實現高個位數到兩位數的恆定貨幣增長。由於我們認為我們將受益於市場環境的改善、HFX iQ 的推出以及 PDN 業務的持續進步，因此預計今年下半年的兩個季度將在 2022 年第三季度和第四季度中期增長。

Finally, I think it's important to review our progress on our journey to drive growth and scale profitably in our core business. For example, let's take a quick look at our operating expenses as a percent of revenue. Over the years, operating expenses, excluding litigation and PDN, have gone from 91% of revenue in 2019 to 84% of revenue in 2022 and are expected to finish 2023 in the high 70s. Many of the changes we continue to invest in, including our Costa Rica facility and development of the PDN market are designed to provide continued improvement in our financial leverage as we grow. We believe that with these investments, we can create even greater leverage in the coming years. But please keep in mind that even including all of these investments I've just mentioned, our full year 2023 operating expenses will only be about 7% higher than those in the full year of 2019.

最後，我認為重要的是要回顧我們在推動核心業務增長和擴大盈利方面取得的進展。例如，讓我們快速看一下我們的運營費用佔收入的百分比。多年來，不包括訴訟和 PDN 在內的運營支出佔收入的比例已從 2019 年的 91% 上升到 2022 年的 84%，預計到 2023 年將達到 70 年代的高位。我們繼續投資的許多變化，包括我們的哥斯達黎加設施和 PDN 市場的開發，旨在隨著我們的成長不斷改善我們的財務槓桿。我們相信，通過這些投資，我們可以在未來幾年創造更大的影響力。但請記住，即使包括我剛才提到的所有這些投資，我們 2023 年全年的運營支出也只會比 2019 年全年高出 7% 左右。

In closing, we made good progress in the fourth quarter and remain on track to drive growth and scale profitably in our core business in the years ahead. We are in a great position strategically with best-in-class SCS technologies, remaining share gain opportunity, future growth opportunities in PDN, NSBP, and our new HFX iQ platform, superior clinical data and a strong commercial organization. We look forward to aggressively attacking the significant opportunities to drive the performance of the business the rest of the year.

最後，我們在第四季度取得了良好進展，並在未來幾年繼續推動我們核心業務的增長和盈利規模。我們在戰略上處於有利地位，擁有一流的 SCS 技術、剩餘的份額增長機會、PDN、NSBP 和我們新的 HFX iQ 平台的未來增長機會、卓越的臨床數據和強大的商業組織。我們期待在今年餘下時間裡積極抓住重要機會來推動業務績效。

That concludes our prepared remarks, and I'll turn the call back over to Julie to moderate the Q&A session.

我們準備好的發言到此結束，我會將電話轉回給 Julie 主持問答環節。

Thanks, Rod. In order to get through the question queue efficiently and take as many questions as we can, we ask that you please limit yourself to one question and one brief related follow-up question. You can then rejoin the queue, and if time allows, we'll take additional questions. Operator, we're ready for the Q&A instructions.

謝謝，羅德。為了有效地通過問題隊列並儘可能多地回答問題，我們要求您將自己限制在一個問題和一個簡短的相關後續問題上。然後您可以重新加入隊列，如果時間允許，我們將回答其他問題。接線員，我們準備好了問答說明。

(Operator Instructions) Your first question comes from Joanne Wuensch with Citibank.

（操作員說明）您的第一個問題來自花旗銀行的 Joanne Wuensch。

I'm a little bit curious about a couple of things. I'm just going to throw them out there in no particular order. Number one, it sounds like you completed the PDN sales force build, and I'm just curious how that is going. Number two, when you talk about historical CAGRs, what's historical CAGRs? And then last but not least, if you can give us an update on the CEO search.

我對一些事情有點好奇。我只是打算把它們扔出去，沒有特定的順序。第一，聽起來你已經完成了 PDN 銷售隊伍的建設，我很好奇進展如何。第二，當你談論歷史 CAGR 時，什麼是歷史 CAGR？最後但並非最不重要的是，如果你能給我們提供有關 CEO 搜索的最新信息。

Okay. Why don't I take the PDN sales force build and the search, and I'll let Rod take the CAGR question. So the PDN referral sales force build is sort of an ongoing process. We tend to go in tranches once or couple times a year in the past. And I think this year, it will be more of a continual building. So we've come into this year with a referral sales team of a little more than 50 individuals. I think we'll probably exit this year with something closer to 80 to 90. And that will be a gradual building in probably a couple of different chunks. That effort, I think, continues to not only go well, but get better and better over time as we learn the backgrounds of those who have been successful, where to put them, how to pair them with our existing SCS sales force, messaging, targeting, et cetera. So I think the point on that particular spear has gotten sharper and sharper.

好的。為什麼我不接受 PDN 銷售隊伍建設和搜索，而我會讓 Rod 回答 CAGR 問題。因此，PDN 推薦銷售隊伍的建立是一個持續的過程。過去，我們傾向於每年分批進行一次或幾次。我認為今年，它將更像是一座持續的建築。因此，我們進入了今年，擁有一支由 50 多人組成的推薦銷售團隊。我認為今年我們可能會以接近 80 到 90 的比例退出。這可能會在幾個不同的塊中逐步構建。我認為，隨著我們了解成功人士的背景、將他們放在哪裡、如何將他們與我們現有的 SCS 銷售團隊、消息傳遞、消息傳遞、瞄準等等。所以我認為那支長矛的尖端變得越來越尖銳。

In terms of the CEO search, Joanne, really, there's not much to add. We obviously just made that announcement pretty recently. I can tell you that we are heavily in the midst of that process. There's a lot of activity. I'm very encouraged by where we are and where I think we'll end up. And when we know more, you will know more. But we continue to be on a path to conclude this, obviously, in calendar year '23, which is our direction. You want to take the CAGR question.

在 CEO 搜索方面，喬安妮，真的，沒有太多要補充的。我們顯然是最近才宣布的。我可以告訴你，我們正處於這個過程中。有很多活動。我對我們所處的位置以及我認為我們最終會達到的位置感到非常鼓舞。當我們知道得更多時，您就會知道得更多。但是，顯然，我們將繼續在 23 日曆年得出結論，這是我們的方向。您想回答 CAGR 問題。

Sure. And Joanne, I think you're referencing the historical sales CAGRs and market CAGRs. In the past, what we've talked about is prior to the pandemic, the market consistently grew in that mid-to-high single-digit compounded annual growth rate on a year-over-year basis. And we've continued to assert that we believe that there's no reason why the core market can't return to those sorts of levels in the near future.

當然。喬安妮，我認為你指的是歷史銷售複合年增長率和市場複合年增長率。過去，我們談論的是在大流行之前，市場一直以中高個位數的複合年增長率同比增長。我們繼續斷言，我們相信核心市場沒有理由不能在不久的將來恢復到那種水平。

Your next question is from the line of Chris Pasquale with Nephron.

您的下一個問題來自 Chris Pasquale 與 Nephron 的合作。

A couple of questions. One on iQ. Just curious whether you have any plans to quantify the clinical benefits of that platform in some trial setting. And then, Keith, you mentioned that you thought that PDN could eventually become 1/3 of the U.S. SCS market. I guess why that number? The opportunity here would seem to be potentially even larger in terms of the number of patients than the core opportunity. So why set that ceiling at 1/3?

幾個問題。一個在 iQ 上。只是好奇您是否有任何計劃在某些試驗環境中量化該平台的臨床益處。然後，基思，你提到你認為 PDN 最終會成為美國 SCS 市場的 1/3。我想為什麼這個數字？就患者數量而言，這裡的機會似乎比核心機會更大。那麼為什麼將上限設置為 1/3？

Okay. Let me take both of those. From an iQ standpoint, keep in mind that what the iQ is doing is automating the patient's journey and progression along an algorithm that's already established. So if you look at all of the clinical data out there in the literature on the performance of high-frequency SCS therapy, pain relief metrics and many other things. That all applies to iQ. The whole idea is to make that journey for the patient because it is something that takes a little bit of time once they go on the therapy is to make that journey quicker, more predictable, and more in the control of the patient.

好的。讓我把這兩個都拿走。從 iQ 的角度來看，請記住 iQ 正在做的是根據已經建立的算法自動完成患者的旅程和進展。因此，如果您查看文獻中關於高頻 SCS 治療、疼痛緩解指標和許多其他內容的所有臨床數據。這一切都適用於 iQ。整個想法是讓患者踏上這段旅程，因為一旦他們開始治療，這會花費一些時間，目的是讓這段旅程更快、更可預測，並且更多地由患者控制。

So we've been generating data now for well over a decade, and it all supports iQ. Now having said that, we are going to continue to gather data specifically on the iQ capabilities and its ability to do what we've said it can do, which is get the patient to relief with more engagement quicker and to keep them there. So we'll continue to gather data, both real-world data, and you'll probably see some more prospective clinical trial activity out of us as well, so stay tuned.

十多年來，我們一直在生成數據，而且都支持 iQ。話雖如此，我們將繼續專門收集有關 iQ 功能的數據及其執行我們所說的功能的能力，即讓患者更快地通過更多參與來緩解壓力並讓他們保持在那裡。因此，我們將繼續收集數據，包括真實世界的數據，您可能還會從我們那裡看到一些更多的前瞻性臨床試驗活動，敬請期待。

In terms of PDN, we're not applying a cap to that market, Chris. I don't think we said anything even close to that. I think what we're trying to do is give you a sense of as we look out over the next 3 to 5 years, and we think about how does the core SCS market grow over that timeframe and what do we think is in the center of the possible, we place it around that area. Look, it's a very large market with patients who are in a great deal of need without any other really good option. So could it be 50% of the SCS market, could it double the SCS market? Of course, those outcomes are possible. The TAM would justify all of them and then some. We're just trying to communicate to you what we think is maybe the center case of our various scenarios. It's not a cap.

就 PDN 而言，我們不會對該市場應用上限，Chris。我認為我們甚至沒有說過任何接近這一點的話。我認為我們正在嘗試做的是讓您了解我們對未來 3 到 5 年的展望，我們會考慮核心 SCS 市場在該時間段內如何增長以及我們認為的核心是什麼在可能的情況下，我們將其放置在該區域周圍。看，這是一個非常大的市場，有大量需要的患者沒有任何其他真正好的選擇。那麼它是否可以佔 SCS 市場的 50%，是否可以使 SCS 市場翻一番？當然，這些結果是可能的。 TAM 會證明所有這些都是合理的，然後是一些。我們只是想向您傳達我們認為可能是我們各種場景的中心案例。這不是帽子。

Your next question is from the line of Larry Biegelsen with Wells Fargo.

你的下一個問題來自富國銀行的 Larry Biegelsen。

This is Vik Chopra in for Larry. A couple of questions from us. So you expect Q1 sales to be down about 17% sequentially, which is a steeper decline than what we saw in 2022, which had the Omicron effect. It's also your easiest comp. Just trying to figure out if this is conservatism or if there's something you're seeing in the market that leads to a greater-than-expected sequential decline in 2023? And then I had a follow-up.

這是拉里的 Vik Chopra。我們有幾個問題。因此，您預計第一季度銷售額將連續下降約 17%，這比我們在 2022 年看到的具有 Omicron 效應的下降幅度更大。這也是您最簡單的組合。只是想弄清楚這是保守主義還是你在市場上看到的某些東西會導致 2023 年的環比下降幅度大於預期？然後我進行了跟進。

Vik, yes, it's definitely within the line of what we've seen historically in other years. So there isn't anything particular to point out. It's the way that as we look at our trialing and perm activity over the months leading up to it, and it leads us to that $94 million to $96 million range that we spoke about. There's really not a whole lot more than that to speak about. And then we do start to see sequential growth throughout the rest of the year to get you to that annual guidance.

Vik，是的，這絕對在我們在其他年份所看到的歷史範圍內。所以沒有什麼特別要指出的。這就是我們查看之前幾個月的試驗和燙髮活動的方式，它使我們達到了我們所說的 9400 萬至 9600 萬美元的範圍。真的沒有太多可談的了。然後我們確實開始看到今年剩餘時間的連續增長，讓你達到年度指導。

The only thing I would add to that, Vik, is that if you look at the comparable period that you're talking about, the pandemic had an impact in the fourth quarter as well, in the last half or 2/3 of the month of December had a pretty dramatic impact. So it's not -- at least in our business. And it's -- so it's not quite as simple as saying, hey, we had a pandemic impact with Omicron in Q1, so why the difference.

維克，我唯一要補充的是，如果你看看你正在談論的可比時期，大流行病也在第四季度產生了影響，在本月的後半個月或 2/3十二月產生了相當大的影響。所以它不是 - 至少在我們的業務中。而且它——所以它並不像說，嘿，我們在第一季度對 Omicron 產生了大流行影響，所以為什麼會有不同。

Got it. Helpful. And then my follow-up is you've talked about pricing pressure in Q4. Just curious what you're seeing now and what you're assuming for 2023.

知道了。有幫助。然後我的後續行動是你談到了第四季度的定價壓力。只是好奇你現在看到了什麼以及你對 2023 年的假設。

Yes. So remember, we're in limited launch of iQ, and we're on the tail end of Omnia. And so yes, we've continued to see some pricing pressure in Q4. As we go throughout the year, we haven't provided any guidance so far on pricing on iQ. We have spoken generally about how with a new product release, we do anticipate that we should be able to get a little bit of a bump in price, but it's a little bit of a complex equation as we roll throughout the year in terms of the mix shifting to iQ and away from Omnia. So we're anticipating overall that pricing roughly holds for the year. But beyond that, we're not providing a lot of specifics on the iQ pricing.

是的。所以請記住，我們正在有限地推出 iQ，我們正處於 Omnia 的尾端。所以是的，我們在第四季度繼續看到一些定價壓力。在我們全年進行的過程中，到目前為止，我們還沒有就 iQ 的定價提供任何指導。我們已經大致談到瞭如何通過新產品發布，我們確實預計我們應該能夠在價格上有所上漲，但隨著我們全年滾動，這有點複雜混合轉向 iQ 並遠離 Omnia。因此，我們總體上預計今年的定價大致會保持不變。但除此之外，我們沒有提供有關 iQ 定價的很多細節。

Your next question comes from the line of Brandon Vazquez with William Blair.

你的下一個問題來自 Brandon Vazquez 和 William Blair 的對話。

Just one quickly on the clinical data that you guys have read out recently, you have 2-year positive datasets for PDN and NSRBP, both strong data in randomized controlled trials. So I assume maybe you guys will start to engage with payers either if you haven't already, you will in the near future, especially in the NSRBP side to try and firm up those coverage decisions. So just curious status on that end and if there's any expectations for updates in the next year.

關於你們最近讀出的臨床數據，你們有 2 年的 PDN 和 NSRBP 陽性數據集，這兩個數據都是隨機對照試驗中的有力數據。所以我假設你們可能會開始與付款人接觸，如果你們還沒有的話，你們會在不久的將來，特別是在 NSRBP 方面嘗試並確定這些覆蓋範圍的決定。所以只是好奇這方面的狀態，以及是否對明年的更新有任何期望。

Well, you're right. The 2-year data is important and it's to some payers very important in terms of follow-up. Now a lot of times, 2-year data in the minds of a payer means a 2-year publication. So while the data now are in and they've been presented, they will be submitted here shortly for peer review and publication in a journal. That doesn't mean we wait for that to communicate with payers. I think as soon as that dataset becomes available, we have them in front of payers, and we're engaging in those discussions now, by the way, on an almost constant basis. Our communications with payers aren't really episodic. They're just ongoing. And we have a strategy for each payer, and it's multiple communication points throughout the year. So we're talking to payers now that the 2-year datasets have been presented. We have to be a little bit careful. We don't want to jeopardize publication. So we don't spend too much time on the details our investigators presented to their peers. So the publication will make it a lot easier for us to do that from a couple of standpoints. And that will come a little bit later this year, hopefully, in the middle part of the year.

嗯，你是對的。 2 年的數據很重要，對於一些付款人而言，它在後續行動方面非常重要。現在很多時候，付款人心目中的 2 年數據意味著 2 年的出版。因此，雖然數據現在已經存在並且已經呈現，但它們將很快提交到這裡進行同行評審並在期刊上發表。這並不意味著我們等待與付款人溝通。我認為一旦該數據集可用，我們就會將它們放在付款人面前，順便說一下，我們現在幾乎一直在參與這些討論。我們與付款人的溝通並不是偶然的。他們只是在進行中。我們為每個付款人制定了一個策略，並且全年都有多個溝通點。所以我們現在正在與付款人交談，因為已經提供了 2 年的數據集。我們必須小心一點。我們不想危及出版。所以我們不會花太多時間在我們的研究人員向他們的同行展示的細節上。因此，從兩個角度來看，該出版物將使我們更容易做到這一點。這將在今年晚些時候出現，希望是在今年年中。

Your next question comes from the line of Robbie Marcus with JPMorgan.

你的下一個問題來自摩根大通的 Robbie Marcus。

I want to start, the guide feels very similar to the guide for 2022 with a depressed first half and a much better second half with mid-teens growth. That didn't end up playing out last year despite a pretty good MedTech environment. So what gives you confidence that the market can accelerate to those mid-teens levels in the back part of the year?

我想開始，該指南感覺與 2022 年的指南非常相似，上半場表現不佳，下半場表現更好，青少年成長。儘管 MedTech 環境非常好，但去年並沒有結束。那麼是什麼讓你有信心市場可以在今年下半年加速到十幾歲的水平呢？

Yes. Look, every year is different. And we based the guidance that we gave during the beginning of the year based on the available data to us at the time. So what happens in 1 year has little read, I think, on what's likely to happen in next. As we look at guidance for this year, Robbie, we're looking at exit velocities of procedures. We're looking at claims data, reported sales, we're looking at a bunch of our own market research with both patients and doctors. And we're making some what we think are probably pretty conservative core market assumptions. And assuming that things like iQ and NSBP data give us the ability to grab a little bit of share in the core back and leg market, although even those assumptions are not what I would call too aggressive.

是的。你看，每年都不一樣。我們根據當時提供給我們的可用數據，在年初給出了指導。因此，我認為，很少有人了解 1 年內發生的事情，以了解下一年可能發生的事情。當我們查看今年的指導時，羅比，我們正在查看程序的退出速度。我們正在查看索賠數據、報告的銷售額，我們正在查看我們自己對患者和醫生進行的大量市場調查。我們正在做一些我們認為可能非常保守的核心市場假設。並假設像 iQ 和 NSBP 數據這樣的東西讓我們有能力在核心背部和腿部市場上搶占一點份額，儘管即使是這些假設我也不會稱之為過於激進。

And then a lot of the growth assumption is based on what we think the trajectory of PDN looks like. We have a lot more data on PDN, obviously, coming into this year than we did last year. It's guidance. It could be wrong on either direction. But I feel like we've got a little bit more illumination this year on what's happening in the market than we did last. And it is our best estimate of where we think this year is at.

然後很多增長假設都是基於我們認為 PDN 的軌跡。顯然，與去年相比，今年我們有更多關於 PDN 的數據。是指導。任何一個方向都可能是錯誤的。但我覺得今年我們對市場上發生的事情比去年有了更多的了解。這是我們對今年情況的最佳估計。

Great. Appreciate it, Keith. And maybe just one follow-up along those lines. The PDN sales for first quarter came in a bit below where the Street was thinking. I think, in general, we weren't expecting that much seasonality during the launch year. So maybe talk to what you're seeing, why PDN seasonality in line with the base business is the right way to start the year and expected. And also, as it ramps, it ends in the low-to-mid 20s, I would imagine, millions to get to the guidance range. How are you thinking about competition in PDN, if at all?

偉大的。欣賞它，基思。也許只是沿著這些思路進行一次跟進。第一季度的 PDN 銷售額略低於華爾街的預期。我認為，總的來說，我們並沒有預料到發布年份會有那麼多的季節性。因此，也許可以談談您所看到的，為什麼與基礎業務一致的 PDN 季節性是今年開始和預期的正確方式。而且，隨著它的上升，它會在 20 年代中期結束，我想，數百萬將達到指導範圍。如果有的話，您如何看待 PDN 中的競爭？

Yes. No, I think the seasonality question is a good one. We actually did some work on that ourselves. Went back and looked at our initial ramp as a company, we looked at some of the initial ramps of other earlier stage, high-growth neuromodulation companies. Seasonality shows up pretty early, and seasonality is, in general, a pretty strong factor in this sector and maybe a little more so than other MedTech sectors that I've been around. And I think generally, what we've seen is seasonality shows up pretty quickly. Once you get past sales growth rates that are not, say, a multiple of prior year, but something sub-100% growth rate, seasonality, at least in the Q4 to Q1 cycle, shows up pretty early. It did for us and it has for other companies. So I don't think we're terribly surprised. I don't think we think it has much bearing on our guidance for the balance of the year. I think PDN is one of those areas of our guidance where we have actually a fairly high degree of -- maybe relatively higher degree of confidence.

是的。不，我認為季節性問題是一個很好的問題。我們實際上自己做了一些工作。回頭看看我們作為一家公司的初始爬坡，我們研究了其他早期階段、高增長的神經調節公司的一些初始爬坡。季節性很早就出現了，總的來說，季節性是這個行業的一個非常重要的因素，而且可能比我去過的其他醫療技術行業更重要一些。而且我認為一般來說，我們所看到的是季節性很快就會出現。一旦你獲得了過去的銷售增長率，比如不是上一年的倍數，而是低於 100% 的增長率，季節性，至少在第四季度到第一季度的周期中，就會很早就出現。它對我們有用，對其他公司也有用。所以我認為我們並不感到非常驚訝。我認為我們認為這對我們對今年餘下時間的指導沒有太大影響。我認為 PDN 是我們的指導領域之一，我們實際上有相當高的信心——也許相對更高的信心。

In terms of competitive approvals, Medtronic's been approved for a while. We've had a pretty good long chance here to see what they've done in the market and how they've changed share or market growth. I think we've talked about this a little bit in the past. We do see them out there. And we're hopeful over time they'll have maybe a bit more impact on the growth of the overall market. But to date, it hasn't been a big impact and certainly hasn't been a big impact in terms of share. Abbott, of course, is now approved. We talked about this before as well. We knew this was coming, especially since Medtronic got their approval based in part on Abbott data. And I think Abbott has made it clear that they submitted virtually the same Medtronic and Abbott data that Medtronic submitted.

在競爭性審批方面，美敦力已經獲批一段時間了。我們在這裡有很好的機會看到他們在市場上做了什麼，以及他們如何改變份額或市場增長。我想我們過去已經談過這個了。我們確實看到他們在那裡。我們希望隨著時間的推移，它們可能會對整個市場的增長產生更大的影響。但到目前為止，它並沒有產生太大的影響，而且在份額方面當然也沒有產生太大的影響。當然，雅培現在已獲得批准。我們之前也談過這個。我們知道這即將到來，特別是因為美敦力部分基於雅培數據獲得了他們的批准。我認為 Abbott 已經明確表示，他們提交的 Medtronic 和 Abbott 數據幾乎與 Medtronic 提交的數據相同。

So we expected this to come. The data that Abbott has out there it isn't new. It's the same data set Medtronic put forward. It's 2014 trials that were never used for a submission before, that never moved the needle with payers or patient referrals before, and we don't really expect them to have a big impact now. Now we hope that Abbott has some impact on awareness of the therapy, awareness among societies, referring doctors, et cetera. But we don't know yet. That's a very new approval. It remains to be seen how much they invest in that, what they do with it, and what impact they have. I think we probably expect it to be, at least this year, relatively minimal.

所以我們預料到了這一點。雅培提供的數據並不新鮮。這與美敦力提出的數據集相同。這是 2014 年的試驗，以前從未用於提交，以前從未對付款人或患者轉診產生過影響，我們真的不希望它們現在產生重大影響。現在我們希望雅培對治療的認識、社會意識、轉診醫生等方面產生一些影響。但我們還不知道。這是一個非常新的批准。他們在這方面投入了多少，用它做了什麼，以及它們產生了什麼影響，還有待觀察。我認為我們可能預計它至少在今年會相對最小。

Your next question is from the line of Rich Newitter with Truist Securities.

你的下一個問題來自 Truist Securities 的 Rich Newitter。

This is Dave Rescott in for Rich. Rod, I wanted to follow up first on a comment you made related to Joanne's question about returning to these historical mid-single-digit to high-single-digit growth rates. Wondering if that comment or that market growth is inclusive of PDN or if that's specifically relevant just to the core SCS market in the U.S. And I guess based on that answer, if guidance for 2023 does assume that there is a return to that historical CAGR? And if so, when?

我是里奇的戴夫·雷斯科特。羅德，我想先跟進你對喬安妮關於恢復到這些歷史性的中個位數到高個位數增長率的問題所做的評論。想知道該評論或市場增長是否包含 PDN，或者它是否僅與美國的核心 SCS 市場特別相關，我想根據這個答案，2023 年的指導是否假設會恢復到歷史 CAGR？如果是這樣，什麼時候？

Yes. Thanks. So when we've talked about the CAGR in the market, we've generally spoken about it from a core back and leg perspective. So we do believe that this market has the potential to return to those sorts of historical year-over-year growth levels that we saw in the 2010 to 2018, 2010 to 2019 sort of period. So we are talking excluding PDN in that case.

是的。謝謝。因此，當我們談論市場上的 CAGR 時，我們通常是從核心背部和腿部的角度來談論它。因此，我們確實相信這個市場有可能恢復到我們在 2010 年至 2018 年、2010 年至 2019 年期間看到的歷史同比增長水平。因此，在這種情況下，我們正在討論排除 PDN。

As far as this year, we're still assuming pretty modest core back and leg market growth on the year with a slower first half and a little bit of a stronger growth period in the second half of the year from a market perspective. So overall, we're anticipating low single digits for the market on the year.

就今年而言，我們仍然假設今年的核心背部和腿部市場增長相當溫和，從市場角度來看，上半年較慢，下半年增長期略強。總的來說，我們預計今年的市場將出現低個位數。

Okay. That's helpful. And then I guess on the -- based on the full year and Q1 adjusted EBITDA guidance, there does appear to be a pretty steep acceleration curve implied between Q2 and Q4. So I'm just wondering if we should be thinking about that improvement as more gradual, more back-end loaded? And then if at all, that more profitable growth you're getting out of HFX iQ, is that product contributing to any of the improvements in the EBITDA profile in 2023?

好的。這很有幫助。然後我猜——基於全年和第一季度調整後的 EBITDA 指導，第二季度和第四季度之間確實存在一條非常陡峭的加速曲線。所以我只是想知道我們是否應該將這種改進視為更漸進、更多的後端加載？然後，如果有的話，您從 HFX iQ 獲得的利潤增長更多，該產品是否有助於 2023 年 EBITDA 概況的任何改善？

Yes. So when you're talking about that acceleration, are you primarily talking revenue, or are you talking adjusted EBITDA?

是的。因此，當您談論這種加速時，您主要是在談論收入，還是在談論調整後的 EBITDA？

Just adjusted EBITDA.

剛剛調整的 EBITDA。

Okay. Yes. So as we mentioned, Q1 historically carries a disproportionate amount of operating expenses. We also mentioned that the first 3 quarters of the year that we're going to have some headwinds from a margin perspective with Costa Rica as we're bringing that manufacturing plant up to scale. We'll start to see some of the expansion, and that's related to iQ as well as Costa Rica getting to sufficient scale in the fourth quarter. So we'll see some of that expansion or I think what you call acceleration in the fourth quarter as a result of that margin expansion, but also with a disproportionate amount of operating expenses in Q1 and then less so in the next 3 quarters. It's driving that adjusted EBITDA expansion you're talking about.

好的。是的。因此，正如我們所提到的，從歷史上看，第一季度的運營費用不成比例。我們還提到，今年前三個季度，隨著我們將該製造廠擴大規模，從利潤率的角度來看，我們將在哥斯達黎加遇到一些不利因素。我們將開始看到一些擴張，這與 iQ 以及哥斯達黎加在第四季度達到足夠規模有關。因此，由於利潤率擴張，我們將在第四季度看到一些擴張，或者我認為你所謂的加速，但第一季度的運營費用不成比例，然後在接下來的三個季度減少。它正在推動您正在談論的調整後的 EBITDA 擴張。

Okay. And just is there any contribution to that margin from the HFX iQ launch? I know you discussed that can drive more profitable growth. Just wondering if there's any contemplation about that in 2023 or if that's more longer term?

好的。 HFX iQ 的發布對利潤率有何貢獻？我知道你討論過這可以推動更有利可圖的增長。只是想知道 2023 年是否對此有任何考慮，或者是否有更長期的考慮？

Yes. So we'll see some expansion from iQ. So there's a couple of factors there. One is it will start to be a significant portion of our product mix later in the year. And we do anticipate that we'll receive some pricing increase as it relates to iQ. We're also manufacturing that product out of Costa Rica. So when we get into Q4, we'll start to see some favorability from iQ being out in the field, both from a price and a cost perspective, and that's driving some of that margin expansion.

是的。所以我們會看到 iQ 的一些擴展。所以那裡有幾個因素。一是它將在今年晚些時候開始成為我們產品組合的重要組成部分。我們確實預計我們會收到一些與 iQ 相關的價格上漲。我們還在哥斯達黎加生產該產品。因此，當我們進入第四季度時，我們將開始看到 iQ 在該領域的一些優勢，無論是從價格還是成本的角度來看，這在一定程度上推動了利潤率的增長。

Well, I would add one more -- maybe one more element to that, and that's the operating expense dimension of iQ. I think when you -- there's a disproportionate amount of support given to patients in their first 3 to 12 months of support on our technology. And so I think when we get to the point where a substantial percentage of all of our new patients are going on to iQ that the promise of less intensive support needed for those patients should start to contribute to our ability to scale a little bit differently. And I think -- so I think where that part of the cost story starts to show up is probably in '24, mostly in '24, where the incremental growth driven by the iQ should be -- should require a little bit less field support and make our field team more efficient in driving that growth.

好吧，我會再添加一個——也許再添加一個元素，那就是 iQ 的運營費用維度。我認為當你 - 在我們的技術支持的前 3 到 12 個月內，為患者提供了不成比例的支持。因此，我認為，當我們達到我們所有新患者中有相當大比例的人繼續使用 iQ 的地步時，這些患者所需的強度較低的支持的承諾應該開始有助於我們擴大規模的能力有所不同。而且我認為 - 所以我認為成本故事的那部分開始出現的地方可能是在 24 世紀，主要是在 24 世紀，iQ 驅動的增量增長應該是 - 應該需要更少的現場支持並使我們的現場團隊更有效地推動這種增長。

Your next question comes from the line of Adam Maeder with Piper Sandler.

你的下一個問題來自 Adam Maeder 和 Piper Sandler 的台詞。

This is Simran on for Adam. Just 2 quick ones from me. So the first one, on NSRBP, have you seen any progress with the payer community? I think you presented the 2-year follow-up data at NANS last month. So I'm just curious how this opportunity is trending both from a reimbursement and patient awareness standpoint? And maybe just specifically, have you seen any impact in the marketplace from the United no-coverage policy that went into effect? I think it was announced at the end of last year. So just if you've seen any impact there.

這是亞當的西姆蘭。我只有 2 個快速的。那麼第一個，關於 NSRBP，您是否看到付款人社區有任何進展？我想你上個月在 NANS 上展示了 2 年的隨訪數據。所以我很好奇這個機會從報銷和患者意識的角度來看是如何發展的？也許只是具體而言，您是否看到生效的美聯航無承保政策對市場產生了任何影響？我認為它是在去年年底宣布的。所以只要你在那裡看到任何影響。

And then just my second question is on the topic of competition in the core SCS market. There is a new entrant coming to the market this year with a closed loop system. So any thoughts on potential impact there and any new dynamics worth highlighting?

然後我的第二個問題是關於核心 SCS 市場競爭的話題。今年有一個新進入者帶著閉環系統進入市場。那麼對那裡的潛在影響有什麼想法，有什麼值得強調的新動態嗎？

Okay. Okay, that's a ton, so let me try and be efficient here. In terms of impact on the payers, yes, we've begun -- we think, to get traction with payers and with patients on an individual basis, getting them approved in the NSBP category, we have been pretty consistent from the very beginning, saying this would play out over time, and it would require ongoing follow-up from the study and other studies, and it would require our competitors jumping in and driving this as well. And we continue to believe that. But we have begun to see some impact. I think having the 24 months data out there and ultimately published will give us a bit more leverage in our payer conversations. But I think this is something that will be a gradual tailwind to the core back and leg market over the next 2, 3, 5 years as we see more data, more patients, and more pressure to treat these patients who don't have an option.

好的。好的，那是一噸，所以讓我在這裡嘗試提高效率。在對付款人的影響方面，是的，我們已經開始——我們認為，在個人基礎上吸引付款人和患者，讓他們在 NSBP 類別中獲得批准，我們從一開始就非常一致，說這會隨著時間的推移而發揮作用，並且需要研究和其他研究的持續跟進，並且需要我們的競爭對手也加入並推動它。我們繼續相信這一點。但我們已經開始看到一些影響。我認為擁有 24 個月的數據並最終發布將使我們在與付款人的對話中有更多的影響力。但我認為這將在未來 2、3、5 年逐漸成為核心背部和腿部市場的順風，因為我們看到更多數據、更多患者以及治療這些沒有選項。

On the UnitedHealthcare decision, we did speak to that in the script a few moments ago. We haven't seen an impact from that to date, and we don't expect to see a material impact this year, which is, I think, is what we said a few months ago, and we reiterated that today. And finally, on the new competitive entry to the market, I think you're referring to Saluda. And they are FDA approved as we understand it for a product they don't intend to broadly launch, and they are waiting for FDA approval for a version of their product that they do hope and intend to broadly launch. And so they're really in a very small limited market release in the U.S. So we're not seeing much of an impact. We're hearing different things. You should ask them, of course, but we're hearing different things. Most frequently, we're hearing sometime later this year for an approval and a market launch.

關於 UnitedHealthcare 的決定，我們剛才在劇本中確實談到了這一點。到目前為止，我們還沒有看到這方面的影響，我們預計今年不會產生實質性影響，我認為這就是我們幾個月前所說的，我們今天重申了這一點。最後，關於新的競爭性進入市場，我認為你指的是 Saluda。據我們了解，他們已獲得 FDA 批准，用於他們不打算廣泛推出的產品，並且他們正在等待 FDA 批准他們希望並打算廣泛推出的產品版本。所以他們在美國的市場發行量非常小，所以我們沒有看到太大的影響。我們聽到了不同的聲音。當然，你應該問他們，但我們聽到的是不同的事情。最常見的是，我們會在今年晚些時候聽到批准和上市的消息。

I'd refer you back to 1 or maybe 2 quarters ago in our transcript, and Julie I'm sure can get it to you. We spoke at great length to the comparison of what we're doing with the iQ product to low-frequency ECAPs closed loop. They are entirely different things. we think we're really well positioned. And I won't go through all that again today because we really spent quite a lot of time on it. And I don't think the fundamental comparison has much changed since then. So anybody who would like to be referred to the proper part of the transcript and the right quarter, just contact Julie Dewey, and she'll get that to you. But I think we feel like we're very well positioned.

我會在我們的成績單中向您推薦 1 個或 2 個季度前，我相信 Julie 可以把它交給您。我們詳細討論了我們使用 iQ 產品與低頻 ECAP 閉環所做的比較。它們是完全不同的東西。我們認為我們確實處於有利地位。今天我不會再講一遍，因為我們真的花了很多時間在這上面。而且我認為從那時起基本比較沒有太大變化。因此，任何想要參考抄本的正確部分和正確四分之一的人，只需聯繫 Julie Dewey，她就會給你。但我認為我們覺得我們的定位非常好。

I think this may be a bit of a pitch battle between low-frequency competitors that do or don't have ECAPs closed loop. I certainly think we have customers that will want to try anything that's new. But the idea of going back to paresthesia, which everyone's been trying to get away from, back to mapping patient to the OR, waking them up to do so, in the face of everything we have to offer, with high frequency and now AI-driven iQ, it seems unlikely to us that it will happen in large numbers. So I like our position, actually, I like the way we're set up in the market with our current offering.

我認為這可能是具有或不具有 ECAP 閉環的低頻競爭對手之間的一場激烈競爭。我當然認為我們的客戶會想要嘗試任何新事物。但是回到每個人都試圖擺脫的感覺異常，回到將患者映射到手術室，喚醒他們這樣做，面對我們必須提供的一切，高頻和現在的 AI-驅動智商，我們似乎不太可能大量發生這種情況。所以我喜歡我們的位置，實際上，我喜歡我們目前的產品在市場上的設置方式。

Your next question is from William Plovanic with Canaccord Genuity.

您的下一個問題來自 William Plovanic 和 Canaccord Genuity。

It's John on for Bill tonight. To go back on the NSBP insurer coverage, Keith. You announced the PDN trial today, which you said could help with reimbursement. Do you think the company should sponsor another clinical trial in NSBP to also (inaudible) those noncoverage policies?

今晚由約翰接替比爾。回到 NSBP 保險公司的保險範圍，基思。你今天宣布了 PDN 試驗，你說這可以幫助報銷。您認為公司是否應該贊助 NSBP 的另一項臨床試驗以也（聽不清）那些未覆蓋的政策？

Sure. I think it could. I think in this case, we assume that our competitors, as they already have started doing, will begin publishing some data on NSBP as well, and we think that will help with payers. I think the payers will tend to look at data as an industry and not make company-by-company distinctions in this area. So I think further trials will help. I think they always help. And I think that's what we'll see both, frankly, from Nevro and from our competitors.

當然。我認為可以。我認為在這種情況下，我們假設我們的競爭對手，正如他們已經開始做的那樣，也將開始在 NSBP 上發布一些數據，我們認為這將有助於付款人。我認為付款人傾向於將數據視為一個行業，而不是在這個領域對公司進行區分。所以我認為進一步的試驗會有所幫助。我認為他們總是有幫助。坦率地說，我認為這就是我們將從 Nevro 和我們的競爭對手那裡看到的。

NSBP is a little bit different. Payers are well aware that these PDN patients have no other options, that they pose a unique and difficult problem for not only the patient but for the payers themselves. And I think they've been very receptive to what we've given them, which has been very high-quality evidence of a new solution. I think in the case of NSBP, payers are probably over the years in the habit of thinking of SCS being end-of-care pathway option, and we are asking them to flex a little different muscle here to think about patients who don't have a surgical option, and therefore, SCS gets moved up a little bit in front of an option that doesn't exist, but they're just not used to thinking of it of the care algorithm that way.

NSBP 有點不同。付款人很清楚這些 PDN 患者別無選擇，他們不僅給患者而且給付款人本身帶來了獨特而困難的問題。而且我認為他們非常接受我們提供給他們的東西，這是新解決方案的高質量證據。我認為就 NSBP 而言，付款人多年來可能習慣於將 SCS 視為護理結束途徑選項，我們要求他們在這裡展示一些不同的肌肉來考慮那些不這樣做的患者有一個手術選項，因此，SCS 在一個不存在的選項前面移動了一點，但他們只是不習慣以這種方式考慮它的護理算法。

So I think we've always viewed NSBP as being a little bit tougher conversation with payers as they get used to a different care pathway for a certain category of patients who aren't surgical candidates. And I think that's exactly what we're seeing. But I think the conversations we've had with payers have been productive. I think they've been completely rational. I think high-quality evidence usually ends up carrying the day, and we believe it will here as well.

因此，我認為我們一直認為 NSBP 與付款人的對話有點艱難，因為他們習慣於對不適合手術的特定類別患者採用不同的護理途徑。我認為這正是我們所看到的。但我認為我們與付款人的對話是富有成效的。我認為他們是完全理性的。我認為高質量的證據通常最終會佔上風，我們相信它也會在這裡。

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

目前沒有其他問題。我現在將把電話轉回給基思格羅斯曼先生作結束語。

Thank you, everyone, for joining us, for taking the time today. I'm sure some of you will have questions after this call, and we'll look forward to taking them. Otherwise, we'll talk to you next quarter.

感謝大家今天抽出時間加入我們。我相信你們中的一些人在這次電話會議後會有疑問，我們期待著回答他們。否則，我們將在下個季度與您交談。

This concludes today's conference call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連接。