(NVRO) 2023 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Hello. My name is Chris, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Nevro Third Quarter 2023 Financial Results Conference Call.

    你好。我叫克里斯,今天我將擔任你們的會議操作員。現在,我歡迎大家參加 Nevro 2023 年第三季財務業績電話會議。

  • (Operator Instructions) Thank you. Ian Tolle, you may begin.

    (操作員說明)謝謝。伊恩·托爾,你可以開始了。

  • Ian Tolle

    Ian Tolle

  • Good afternoon, and welcome to Nevro's Third Quarter 2023 Earnings Conference Call. With me today are Kevin Thornal, CEO & President and Rod MacLeod, Chief Financial Officer. On today's call, Kevin will discuss third quarter business results, and Rod will conclude with detailed financials and guidance before we open up the call for questions.

    下午好,歡迎參加 Nevro 2023 年第三季財報電話會議。今天與我在一起的有執行長兼總裁凱文·索納爾 (Kevin Thornal) 和財務長羅德·麥克勞德 (Rod MacLeod)。在今天的電話會議上,凱文將討論第三季的業務業績,羅德將在我們開始提問之前提供詳細的財務數據和指導。

  • Please note there are also slides available related to Nevro's third quarter performance on their Investor Relations website in the Events and Presentations section. Earlier today, Nevro released its financial results for the third quarter ended September 30, 2023. A copy of the earnings release is available on the Investor Relations section of the Nevro website at nevro.com.

    請注意,在其投資者關係網站的「活動和簡報」部分中還提供了與 Nevro 第三季業績相關的幻燈片。今天早些時候,Nevro 發布了截至 2023 年 9 月 30 日的第三季財務業績。收益報告的副本可在 Nevro 網站 nevro.com 的投資者關係部分取得。

  • This call is being broadcast live over the Internet to all interested parties on November 1, 2023, and an archived copy of this webcast will be available on Nevro's Investor Relations website.

    此次電話會議將於 2023 年 11 月 1 日透過網路向所有有興趣的各方進行直播,並且該網路廣播的存檔副本將在 Nevro 的投資者關係網站上提供。

  • 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. Results could differ materially from those expressed or implied as a result of certain risks and uncertainties. Please refer to Nevro's SEC filings, including its annual report on Form 10-K, filed on February 21, 2023, for a detailed presentation of risks. The forward-looking statements in this call speak only as of today, and the company undertakes no obligation to update or revise any of these statements.

    在開始之前,我想提醒大家,今天電話會議中發表的評論可能包括聯邦證券法含義內的前瞻性陳述。由於某些風險和不確定性,結果可能與明示或暗示的結果有重大差異。請參閱 Nevro 向 SEC 提交的文件,包括 2023 年 2 月 21 日提交的 10-K 表格年度報告,以了解詳細的風險介紹。本次電話會議中的前瞻性陳述僅代表今天的情況,本公司不承擔更新或修改任何這些陳述的義務。

  • In addition, management will refer to adjusted EBITDA, a non-GAAP measure used to help investors understand Nevro's ongoing business performance. Non-GAAP adjusted EBITDA excludes interest, taxes, non-cash items such as stock-based compensation, depreciation and amortization, litigation-related expenses, certain litigation charges and credits, and other adjustments such as restructuring charges. Please refer to the GAAP to non-GAAP reconciliation tables within the earnings release.

    此外,管理層將參考調整後的 EBITDA,這是一種非 GAAP 衡量標準,用於幫助投資者了解 Nevro 的持續業務績效。非公認會計準則調整後的 EBITDA 不包括利息、稅項、非現金項目(例如股票薪酬)、折舊和攤提、訴訟相關費用、某些訴訟費用和抵免以及重組費用等其他調整。請參閱收益報告中的 GAAP 與非 GAAP 調整表。

  • And now, it's my pleasure to turn the call over to Kevin.

    現在,我很高興將電話轉給凱文。

  • Kevin R. Thornal - President, CEO & Director

    Kevin R. Thornal - President, CEO & Director

  • Thanks, Ian, and good afternoon, everyone. We appreciate you joining us. On today's call, I'd like to discuss our progress on our 3 pillars of growth, our third quarter results, the overall SCS market, and our updated 2023 revenue guidance. I will then turn the call over to Rod to discuss the details of our Q3 financials.

    謝謝伊恩,大家下午好。我們感謝您加入我們。在今天的電話會議上,我想討論我們在三大成長支柱、第三季業績、整體 SCS 市場以及更新的 2023 年收入指引方面取得的進展。然後我會將電話轉給羅德,討論我們第三季財務狀況的細節。

  • As we discussed during our second quarter earnings call, we believe focusing on commercial execution, market penetration and profit progress is essential to moving our business forward to the next level.

    正如我們在第二季財報電話會議上所討論的那樣,我們相信專注於商業執行、市場滲透和利潤進展對於將我們的業務推向新的水平至關重要。

  • Starting with our first pillar of growth, commercial execution. In mid-June, Greg Siller was appointed Senior Vice President and Chief Commercial Officer and was given the mandate of increasing sales productivity, improving physician education, and maximizing the growth opportunity of Nevro. While changes don't happen overnight, Greg has hit the ground running and has quickly made his mark, guided by the philosophy and approach of talent, strategy and culture.

    從我們的第一個成長支柱—商業執行開始。 6 月中旬,Greg Siller 被任命為高級副總裁兼首席商務官,其任務是提高銷售效率、改善醫生教育並最大限度地提高 Nevro 的成長機會。雖然變化不會在一夜之間發生,但格雷格在人才、策略和文化的理念和方法的指導下,已經開始行動並迅速取得了自己的成績。

  • During the third quarter, Greg implemented several key changes, including: realigning our sales force to improve rep performance, filling and rightsizing our sales territories, and enhancing the compensation plan to align the sales force at the customer level. In the third quarter, Greg and his team turned their focus to our marketing department.

    在第三季度,格雷格實施了幾項關鍵變革,包括:重新調整我們的銷售團隊以提高銷售代表績效,充實和調整我們的銷售區域,以及加強薪酬計劃以在客戶層面調整銷售團隊。在第三季度,格雷格和他的團隊將重點轉向了我們的行銷部門。

  • While the ongoing commercial changes will be dynamic for both sales and marketing, we are driving focus and execution on areas of the business that will move the needle from both a growth and leverage perspective; for instance, new product introductions and expanded indications of the current portfolio.

    雖然持續的商業變化對於銷售和行銷來說都是動態的,但我們正在推動業務領域的重點和執行,這將從成長和槓桿的角度推動發展;例如,新產品的推出和目前產品組合的擴展適應症。

  • Another area of focus is to increase our physician education and training, specifically fellowship programs. All chronic pain patients deserve our best-in-class, high-frequency, paresthesia-free therapy, and we must continually educate implanting physician on why it's superior and differentiated. Best practice dictate that multiple physician touch points in training are essential, despite having the best-in-class technology. Over the past 90 days, we trained over 100 fellows on the implementation -- implantation and use of the unique capabilities of our HFX iQ system.

    另一個重點領域是加強我們的醫生教育和培訓,特別是獎學金計劃。所有慢性疼痛患者都應該接受我們一流的、高頻的、無感覺異常的治療,並且我們必須不斷地教育植入醫生為什麼它是優越的和與眾不同的。最佳實踐表明,儘管擁有一流的技術,但培訓中的多個醫生接觸點仍然至關重要。在過去的 90 天裡,我們對 100 多名研究員進行了 HFX iQ 系統獨特功能的實施、植入和使用的培訓。

  • These 3 Cadaver Skill Lab, held in 3 different areas of the country, allow physicians in their fellowship program to learn more about the benefits of our HFX iQ system and why it is technologically superior to other SCS offerings. In addition to these training sessions, we held many targeted local events to provide additional knowledge and training to physicians nationwide.

    這 3 個屍體技能實驗室在全國 3 個不同的地區舉行,讓參加獎學金計劃的醫生能夠更多地了解我們的 HFX iQ 系統的優點以及它在技術上優於其他 SCS 產品的原因。除了這些培訓課程之外,我們還舉辦了許多有針對性的當地活動,為全國的醫生提供更多的知識和培訓。

  • Moving to our second pillar of growth, market penetration. Nevro can expand the market in several ways. For example, through our PDN indication. In August, we announced the publication of 24-month data from the SENZA Painful Diabetic Neuropathy, PDN; randomized controlled trial, RCT in Diabetes Research and Clinical Practice. These data, which were also presented during the American Diabetes Association 83rd Scientific Sessions demonstrated high-frequency 10-kilohertz SCS long-term efficacy in treating refractory PDN.

    轉向我們的第二個成長支柱:市場滲透。 Nevro 可以透過多種方式拓展市場。例如,透過我們的 PDN 指示。 8 月,我們宣布發布 SENZA 疼痛性糖尿病神經病變 (PDN) 的 24 個月數據;隨機對照試驗,糖尿病研究和臨床實踐中的隨機對照試驗。這些數據也在美國糖尿病協會第 83 屆科學會議上公佈,證明了高頻 10 kHz SCS 在治療難治性 PDN 方面的長期療效。

  • The data shows that patients who received a high-frequency 10-kilohertz SCS implant and conventional medical management CMM, compared to CMM alone, experienced durable pain relief with a 90.1% responder rate and significant improvements in both human-related quality of life and sleep at 24 months post implementation.

    數據顯示,與單獨使用CMM 相比,接受高頻10 kHz SCS 植入和傳統醫療管理CMM 的患者經歷了持久的疼痛緩解,反應率為90.1%,並且與人類相關的生活品質和睡眠品質均顯著改善實施後 24 個月。

  • These robust data are critical and set Nevro apart from its competition, as our technology demonstrates durable pain relief and significant improvements without paresthesia. This is so important because a large portion of PDN patients suffer from numbness, which is how products from our competitors mask PDN pain. Using paresthesia as the mechanism of action may increase the overall numbness a patient already experiences. These robust data, combined with health plan coverage of over 205 million lives for PDN gives us an excellent opportunity to expand the market for our best-in-class technology.

    這些可靠的數據至關重要,使 Nevro 從競爭對手中脫穎而出,因為我們的技術展示了持久的疼痛緩解和顯著的改善,且沒有感覺異常。這一點非常重要,因為很大一部分 PDN 患者都患有麻木症,這就是我們競爭對手的產品如何掩蓋 PDN 疼痛的原因。使用感覺異常作為作用機制可能會增加患者已經經歷的整體麻木感。這些可靠的數據,加上 PDN 覆蓋超過 2.05 億人的健康計劃,為我們提供了絕佳的機會來擴大我們一流技術的市場。

  • Regarding our new PDN Sensory study, the enrollment now stands at almost 50 patients. We're very excited about this study as it is the first prospective RCT specifically designed to evaluate changes in pain and neurological function using high-frequency 10-kilohertz SCS therapy in patients with chronic intractable lower limb pain associated with PDN. We will keep you updated on the enrollment progression of this important clinical trial.

    關於我們新的 PDN Sensory 研究,目前入組的患者人數接近 50 名。我們對這項研究感到非常興奮,因為它是第一個專門設計用於評估使用高頻 10 kHz SCS 治療與 PDN 相關的慢性頑固性下肢疼痛患者的疼痛和神經功能變化的前瞻性隨機對照試驗。我們將隨時向您通報這項重要臨床試驗的註冊進度。

  • Last quarter, we mentioned the potential of augmenting our product portfolio through strategic opportunities. We've received many questions on this topic, so I'd like to briefly expand how we think about a potential acquisition. We have a large global field force that interacts with treating physicians, and we believe we can leverage those call points to: one, strengthen our physician relationships; two, increase our growth; and three, accelerate our path to profitability.

    上個季度,我們提到了透過策略機會擴大我們產品組合的潛力。我們收到了許多有關此主題的問題,因此我想簡要闡述我們對潛在收購的看法。我們擁有一支龐大的全球現場隊伍,與治療醫生互動,我們相信我們可以利用這些呼籲:第一,加強我們的醫生關係;二、增加我們的成長;第三,加速我們的獲利之路。

  • There are many potential adds to our sales bag that we are currently evaluating to take advantage of the synergies with our best-in-class SCS therapy that will be accretive to our margin and growth, but we will be thoughtful as we explore opportunities and will only expend our capital if a potential target meets all of our criteria. We will be a disciplined buyer.

    我們目前正在評估許多潛在的銷售內容,以利用與我們一流的 SCS 療法的協同效應,這將增加我們的利潤和增長,但我們在探索機會時會深思熟慮,並將僅當潛在目標符合我們的所有標準時,我們才會花費我們的資金。我們將成為一個有紀律的買家。

  • And finally, profit progress. We continue to invest in our Costa Rica manufacturing plant and have other initiatives ongoing as we drive towards profitability. The manufacturing ramp at our Costa Rica plant is proceeding as 46% of our iQ volumes were manufactured in our Costa Rica plant in Q3, and we continue to evaluate our internal processes, looking for additional ways to improve our operational efficiencies.

    最後,利潤進展。我們繼續投資哥斯達黎加製造工廠,並在努力實現盈利的過程中採取其他舉措。我們的哥斯達黎加工廠的生產進度正在加快,第三季度我們的 iQ 產量的 46% 是在我們的哥斯達黎加工廠生產的,我們將繼續評估我們的內部流程,尋找其他方法來提高我們的營運效率。

  • Turning now to our third quarter results. For the 3 months ending September 30, 2023, Nevro reported revenue of $103.9 million, an increase of 3% on both a reported and constant currency basis compared to prior year results. Our permanent procedure growth was 7% year-over-year and PDN had another strong quarter, increasing revenue by 56% compared to last year.

    現在轉向我們的第三季業績。截至 2023 年 9 月 30 日的三個月,Nevro 報告營收為 1.039 億美元,與去年業績相比,按報告和固定匯率計算增長了 3%。我們的永久性手術年增 7%,PDN 又一個強勁的季度,收入比去年增加了 56%。

  • In the third quarter, HFX iQ accounted for roughly 43% of our permanent implant procedures, up 1,300 basis points over the previous quarter, and we expect this trend to continue. The feedback for HFX iQ and its ability to deliver personalized pain relief continues to be very positive, and we are confident that the combination of our superior high-frequency, paresthesia-free SCS technology and our HFX algorithm will enable us to outpace our competitors.

    第三季度,HFX iQ 約占我們永久植牙手術的 43%,比上一季上升 1,300 個基點,我們預計這一趨勢將持續下去。對 HFX iQ 及其提供個人化疼痛緩解的能力的反饋仍然非常積極,我們相信,我們卓越的高頻、無感覺異常 SCS 技術與 HFX 演算法的結合將使我們超越競爭對手。

  • While we believe we held share in new implants this quarter, we are obviously not content as it is our moral obligation to win for patients to receive the superior pain relief from the only high-frequency SCS provider in the world. Additionally, with 3 of the leading players having now reported growth for the quarter, we remain confident that the SCS market continues on the road to recovery and showing consistent growth.

    雖然我們相信本季度我們在新植入物中佔有份額,但我們顯然並不滿足,因為讓患者從世界上唯一的高頻 SCS 提供者那裡獲得卓越的疼痛緩解是我們的道德義務。此外,由於 3 家領先企業現已報告本季的成長,我們仍然相信 SCS 市場繼續走上復甦之路並顯示出持續成長。

  • Turning now to our PDN business,. PDN trials represented approximately 24% of our total U.S. trial volume, an increase of 41% from Q3 of last year. Among our permanent implant procedures, PDN represented 20% of total worldwide procedures, resulting in approximately $21 million in PDN indication sales.

    現在轉向我們的 PDN 業務。 PDN 試驗約占美國總試驗量的 24%,比去年第三季增加了 41%。在我們的永久性植入手術中,PDN 佔全球手術總量的 20%,PDN 適應症銷售額約為 2,100 萬美元。

  • In Q3, approximately 21% of our U.S. PDN trial procedures came from leads generated from our direct-to-consumer marketing program. We believe that patient and physician education is imperative to drive awareness of the proven clinical benefits for patients that suffer from debilitating painful diabetic neuropathy.

    在第三季度,我們約 21% 的美國 PDN 試驗程序來自我們的直接面向消費者的行銷計畫所產生的銷售線索。我們相信,患者和醫生的教育對於提高對患有令人衰弱、痛苦的糖尿病神經病變的患​​者的已證實的臨床益處的認識至關重要。

  • I would now like to say a few words about our updated guidance. First, while we exceeded our Q3 expectations, we know we can accelerate our top line growth. We have made many changes to our marketing and commercial teams over the past several months, and it will take time for these changes to translate into meaningful financial results.

    我現在想就我們更新的指南說幾句話。首先,雖然我們超出了第三季的預期,但我們知道我們可以加速營收成長。在過去的幾個月裡,我們對行銷和商業團隊進行了許多改變,這些改變需要時間才能轉化為有意義的財務表現。

  • The positive enhancements we have driven in our culture over the last 7 months have been significant, and we believe these changes will lead to a stronger Nevro. We are confident in the direction of our company and look forward to executing our current strategies, driving growth and taking advantage of the meaningful leverage opportunities we have to drive towards profitability and deliver shareholder value.

    在過去 7 個月裡,我們在文化方面取得了顯著的積極進步,我們相信這些變化將帶來更強大的 Nevro。我們對公司的發展方向充滿信心,並期待執行當前的策略,推動成長並利用有意義的槓桿機會來推動獲利並創造股東價值。

  • Before turning the call over to Rod, I would like to briefly discuss our thoughts on GLP-1s and proactively explain why these therapies will not adversely impact our PDM business. There has been a lot of noise regarding how GLP-1s will affect the market for medical devices. We acknowledge that these therapies can help many people with obesity lose weight and patients with diabetes lower their A1c.

    在將電話轉給 Rod 之前,我想簡要討論一下我們對 GLP-1 的想法,並主動解釋為什麼這些療法不會對我們的 PDM 業務產生不利影響。關於 GLP-1 將如何影響醫療器材市場存在著許多爭議。我們承認這些療法可以幫助許多肥胖症患者減肥,並幫助糖尿病患者降低 A1c。

  • This is not our target patient population, however, and GLP-1s were never intended to, nor do they address PDN. Many PDN patients have been using GLP-1s for years to control their glucose level. And importantly, these drugs have never been shown to reduce the incidence of PDN or the severity of its symptoms.

    然而,這不是我們的目標患者群體,GLP-1 從來沒有打算這樣做,也沒有解決 PDN。許多 PDN 患者多年來一直使用 GLP-1 來控制血糖水平。重要的是,這些藥物從未被證明可以降低 PDN 的發生率或其症狀的嚴重程度。

  • In fact, a large number of patients that were included in our SENZA PDN study were already taking GLP-1s or similar types of drugs for years, and unfortunately, still suffered from painful diabetic neuropathy. These patients responded very well to our high-frequency SCS therapy.

    事實上,我們的 SENZA PDN 研究中納入的大量患者已經服用 GLP-1 或類似類型的藥物多年,但不幸的是,他們仍然患有痛苦的糖尿病神經病變。這些患者對我們的高頻 SCS 治療反應良好。

  • PDN is not simply a result of a patient's A1c or their weight, and even patients with normal BMI and controlled A1c levels experience PDN. We continue to believe that there remains a large addressable refractory PDN market around 2 million to 3 million patients, and penetration rates are very low in that market today.

    PDN 不僅僅是患者 A1c 或體重的結果,甚至 BMI 正常且 A1c 水平受控的患者也會經歷 PDN。我們仍然相信,仍有一個龐大的難治性 PDN 市場,約有 200 萬至 300 萬患者,但目前該市場的滲透率非常低。

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

    接下來,我會將電話轉接給羅德,以提供有關我們第三季業績和指導的更多詳細資訊。

  • Roderick H. MacLeod - Senior VP & CFO

    Roderick H. MacLeod - Senior VP & CFO

  • Thanks, Kevin, and good afternoon. I'll begin with our worldwide revenue for the third quarter of 2023, which increased 3% as reported and on a constant currency basis compared to the third quarter of 2022. PDN represented 20% of permanent implant procedures worldwide, resulting in approximately $21 million in PDN indication sales in the third quarter of 2023. This quarter included 1 less selling day than Q3 of 2022.

    謝謝,凱文,下午好。我將從2023 年第三季的全球收入開始,以固定匯率計算,與2022 年第三季相比,該收入增長了3%。PDN 佔全球永久植入手術的20%,帶來約2,100 萬美元的收入2023 年第三季的 PDN 指示銷售額。本季的銷售天數比 2022 年第三季少 1 個。

  • U.S. revenue in the third quarter of 2023 was $89.8 million, an increase of 4% compared to the third quarter of 2022. International revenue in the third quarter of '23 was $14.1 million, down 2% as reported and down 6% on a constant currency basis.

    2023 年第三季美國營收為 8,980 萬美元,較 2022 年第三季成長 4%。2023 年第三季國際營收為 1,410 萬美元,報告下降 2%,較常量下降 6%貨幣基礎。

  • Now, moving on to some detail below the top line. Gross margin was 66.9% in the third quarter of 2023 compared to 69% in the third quarter of '22. The full market release of the HFX iQ system continues to progress well, and we are capturing a pricing uplift on our HFX iQ product. Our legacy products, which still represent over 50% of our mix, continue to experience pricing erosion.

    現在,繼續討論頂線下方的一些細節。 2023 年第三季的毛利率為 66.9%,而 2020 年第三季的毛利率為 69%。 HFX iQ 系統的全面市場發布繼續進展順利,我們正在抓住 HFX iQ 產品的定價上漲。我們的傳統產品仍占我們產品組合的 50% 以上,價格繼續受到侵蝕。

  • This pricing pressure along with regulatory delays of selling iQ into Europe and the reduction in second half guidance on volumes, continue to cause us to sell off our higher cost iQ products sourced from contract manufacturers. We are still optimistic on our long-run margin expansion opportunities with our Costa Rica sourced products, assuming pricing remains stable.

    這種定價壓力以及向歐洲銷售 iQ 的監管延遲以及下半年銷售指導的減少,繼續導致我們出售來自合約製造商的成本較高的 iQ 產品。假設價格保持穩定,我們仍然對哥斯達黎加採購產品的長期利潤擴張機會持樂觀態度。

  • Looking at operating expenses, the total for the third quarter of 2023 was $95.1 million compared to $92.2 million in the third quarter of 2022, excluding the $105 million of certain litigation credits in the third quarter of 2022. The increase in OpEx was primarily due to litigation and personnel-related costs, partially offset by a decrease in stock-based compensation. Litigation related legal expenses were $4.3 million for the third quarter of 2023 compared to $1.9 million in the third quarter of 2022.

    從營運支出來看,2023 年第三季的營運支出總額為9,510 萬美元,而2022 年第三季為9,220 萬美元,不包括2022 年第三季的1.05 億美元的某些訴訟信貸。營運支出的增加主要是由於訴訟和人事相關成本,部分被股票薪酬的減少所抵銷。 2023 年第三季訴訟相關法律費用為 430 萬美元,而 2022 年第三季為 190 萬美元。

  • Non-GAAP adjusted EBITDA for the third quarter of 2023 was a loss of $5.8 million compared to a loss of $3.8 million in the third quarter of 2022. Cash, cash equivalents and short-term investments totaled $320.3 million as of September 30, 2023. This represents a decrease during the third quarter of 2023 of $9.7 million. Uses of cash were in line with normal business operations as well as our projections. We continue to manage our working capital and are very comfortable with our balance sheet to fund operations.

    2023 年第三季非 GAAP 調整後 EBITDA 虧損 580 萬美元,而 2022 年第三季虧損 380 萬美元。截至 2023 年 9 月 30 日,現金、現金等價物和短期投資總額為 3.203 億美元。這意味著2023 年第三季減少了970 萬美元。現金的使用符合正常業務運作以及我們的預測。我們繼續管理我們的營運資金,並對我們的資產負債表為營運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.

    現在轉向指導。值得注意的是,我們將使用非公認會計準則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有關 GAAP 與非 GAAP 調整的財務表格。

  • We expect fourth quarter worldwide revenue of approximately $108 million to $110 million, which represents a decrease of 4% to 6% on a constant currency basis. We expect fourth quarter of 2023 non-GAAP adjusted EBITDA to be a gain of approximately $1 million to $2 million.

    我們預計第四季度全球營收約為 1.08 億至 1.1 億美元,以固定匯率計算下降 4% 至 6%。我們預計 2023 年第四季非 GAAP 調整後 EBITDA 將實現約 100 萬至 200 萬美元的收益。

  • We expect worldwide revenue for full year 2023 of approximately $417 million to $419 million, an increase of 3% over prior year on both an as-reported and constant currency basis. We expect full year 2023 non-GAAP adjusted EBITDA to be in the range of negative $24 million to negative $25 million, which compares to a non-GAAP adjusted EBITDA loss of $23.8 million in 2022.

    我們預計 2023 年全年全球營收約為 4.17 億至 4.19 億美元,按報告和固定匯率計算均較上年增長 3%。我們預計 2023 年全年非 GAAP 調整後 EBITDA 將在負 2,400 萬美元至負 2,500 萬美元之間,而 2022 年非 GAAP 調整後 EBITDA 虧損為 2,380 萬美元。

  • In closing, we continue to make good progress and remain on track to drive growth and scale profitably in our core business in the years ahead. We are strategically positioned with best-in-class SCS technologies. And with the changes we are making to our commercial and marketing functions, we expect to outpace our competitors and expand the overall market. Our strategic plan is in place, and now it's time to execute it.

    最後,我們繼續取得良好進展,並繼續走在未來幾年推動核心業務成長和獲利規模的軌道上。我們的策略定位是擁有一流的 SCS 技術。隨著我們對商業和行銷職能的改變,我們期望超越競爭對手並擴大整體市場。我們的策略計劃已經到位,現在是執行它的時候了。

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

    我們準備好的演講到此結束。我會將電話轉回伊恩主持問答環節。

  • Ian Tolle

    Ian Tolle

  • 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 a brief related follow-up question. You can then rejoin the queue, and if time allows, we will take additional questions.

    謝謝,羅德。為了有效地完成問題隊列並回答盡可能多的問題,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。

  • Operator, we are ready for Q&A instructions.

    接線員,我們已準備好接受問答說明。

  • Operator

    Operator

  • (Operator Instructions) Our first question is from Shagun Singh with RBC Capital.

    (操作員說明)我們的第一個問題來自 RBC Capital 的 Shagun Singh。

  • Shagun Singh Chadha - Research Analyst

    Shagun Singh Chadha - Research Analyst

  • I just wanted to touch on Q4 revenue guidance. It looks like it's slightly below consensus, and it implies sales down 4% to 6%. Should we view it as conservative, since you have indicated that you would rather be on a trajectory to beat-and-raise? And then also, what does the exit rate imply for 2024? Perhaps you can share more broadly with us your view of the SCS market recovery, competition, uptake of PDN; if you can just help us frame 2024, that would be really helpful.

    我只想談談第四季的營收指引。看起來略低於共識,這意味著銷售額下降 4% 至 6%。既然您已經表示您寧願走在擊敗和加註的軌道上,我們是否應該將其視為保守?另外,2024 年的退出率又意味著什麼?也許您可以與我們更廣泛地分享您對 SCS 市場復甦、競爭、PDN 吸收的看法;如果您能幫助我們制定 2024 年框架,那將非常有幫助。

  • Kevin R. Thornal - President, CEO & Director

    Kevin R. Thornal - President, CEO & Director

  • Yes. Thank you for the questions there, and I'll take a crack at the first ones, then I hand it over to Rod for the second part. So, for guidance, obviously, there's a lot of things going on in the world from a macro level right now. We're also still underway with our transition of Greg coming in and the changes in our commercial organization, and so, we want to make sure that we continue down and make the right decisions we need to for the business to set us up for the future. And so, those things play into our guidance for Q4.

    是的。謝謝你們提出的問題,我會先解決第一部分,然後將第二部分交給羅德。因此,作為指導,顯然,從宏觀層面來看,目前世界上正在發生很多事情。我們仍在進行格雷格的過渡以及我們商業組織的變化,因此,我們希望確保我們繼續下去並做出我們需要的正確決策,以便業務為我們做好準備未來。因此,這些因素都會影響我們對第四季的指引。

  • Also, just thinking through from a competitive standpoint, we do now have -- 3 of us have now reported on SCS and all 3 reported growth, albeit a little bit lower from a couple of us in the low-single-digits, and we'll see what our fourth competitor or the fourth player in the market here in a few weeks will report. And so, yes, we still feel confident on the recovery. We feel good that now this is multiple quarters where all 4 players have shown some growth or 1 quarter that 1 player didn't, but pretty consistent growth now, but definitely not to the levels where we were prior to COVID. And so that plays into that as well.

    另外,從競爭的角度考慮,我們現在確實有——我們中的3 個人已經報告了SCS,並且所有3 個人都報告了增長,儘管比我們中的幾個人的低個位數要低一些,而且我們我們將在幾週內看到我們的第四個競爭對手或市場上的第四個參與者將報告什麼。因此,是的,我們仍然對復甦充滿信心。我們感覺很好,現在是多個季度,所有4 名玩家都表現出了一定的增長,或者有1 個季度1 名玩家沒有出現增長,但現在的增長相當一致,但絕對沒有達到新冠疫情爆發之前的水平。這也起到了作用。

  • And I'll turn it over to Rod to talk about exit rates and any other guidance.

    我會將其交給羅德討論退出率和任何其他指導。

  • Roderick H. MacLeod - Senior VP & CFO

    Roderick H. MacLeod - Senior VP & CFO

  • Yes. Shagun, thanks for the question. And then, just to add a little bit on Q4. We've got our typical Q4 seasonality built in there, which is showing the sequential ramp up from Q3 into Q4 as well. We don't normally -- we're not providing guidance on 2024 at this point, and we generally don't get so granular to provide exit rates.

    是的。沙貢,謝謝你的提問。然後,在第四季度添加一點內容。我們在那裡建立了典型的第四季季節性,這也顯示了從第三季到第四季的連續成長。我們通常不會——目前我們不會提供 2024 年的指導,而且我們通常不會如此詳細地提供退出率。

  • Kevin spoke generally about where the market has been performing over the last 3 quarters, and we remain optimistic that that sort of growth is trending in the right direction. But beyond that, there's not a whole lot more color in terms of what our exit rate will be going into next year.

    凱文概括地談到了過去三個季度市場的表現,我們仍然樂觀地認為這種成長正在朝著正確的方向發展。但除此之外,就明年的退出率而言,並沒有更多的色彩。

  • Operator

    Operator

  • The next question is from Anthony Petrone with Mizuho Securities.

    下一個問題來自瑞穗證券的 Anthony Petrone。

  • Bradley Thomas Bowers - Senior Associate

    Bradley Thomas Bowers - Senior Associate

  • Great. Just one follow-up here, kind of on the 4Q guide. This is Brad, by the way, on for Anthony. Just looking at, I guess, what you're kind of implying from the core business, it seems the trend we're looking at in the fourth quarter, at least per guidance, is actually one of the worst, I guess, core -- quarters since the back half of 2021, I guess, when we first saw Nevro revenue kind of falling in the core business. So just kind of wanted to hear what the thought process was on that trend. What you're seeing, I guess, within the core business at those practices.

    偉大的。這裡只是一個後續行動,有點像 4Q 指南。順便說一句,這是安東尼的布拉德。我想,看看你從核心業務中暗示的內容,我們在第四季度看到的趨勢,至少根據指導,實際上是最糟糕的趨勢之一,我想,核心 - - 我猜想是自2021 年下半年以來的幾個季度,當時我們第一次看到Nevro 核心業務的收入有所下降。所以只是想聽聽關於這個趨勢的思考過程。我想,您在這些實踐的核心業務中所看到的。

  • Kevin R. Thornal - President, CEO & Director

    Kevin R. Thornal - President, CEO & Director

  • Thanks, Brad. Again, starting off with the macro environment, right? I mean, we've got 2 wars going on right now, and I'm watching all of my colleagues at other medical device companies, what they're saying right now. And so, obviously, want to make sure in this environment that we're thinking through anything that could happen from a macro trend level.

    謝謝,布拉德。還是從宏觀環境開始吧?我的意思是,我們現在正在進行兩場戰爭,我正在觀察其他醫療設備公司的所有同事,他們現在在說什麼。因此,顯然,我們希望確保在這種環境下,我們正在考慮從宏觀趨勢層面可能發生的任何事情。

  • As far as the core market itself, again, we posted a 3% growth. One of our competitors was probably 2% to 3% growth in the core market, and then one had an outlier replacement of batteries and that's not new patients as we talked through. So we are a little bit cautiously optimistic about the market returning back to where it was before. But obviously, with this macro environment overhang, it's a little bit affecting capital markets probably more than it would for implants, but we also wanted to be a little bit cautious with what's going on in the world.

    就核心市場本身而言,我們再次實現了 3% 的成長。我們的一位競爭對手可能在核心市場實現了 2% 到 3% 的成長,然後一位競爭對手更換了異常的電池,正如我們所說,這並不是新患者。因此,我們對市場回到之前的水平持謹慎樂觀的態度。但顯然,在這種宏觀環境懸而未決的情況下,它對資本市場的影響可能比植入更大,但我們也希望對世界上正在發生的事情保持謹慎。

  • Rod, anything to add there?

    羅德,還有什麼要補充的嗎?

  • Roderick H. MacLeod - Senior VP & CFO

    Roderick H. MacLeod - Senior VP & CFO

  • Yes. Just one thing to reiterate is that we are still early in this -- in the changes on the commercial side of the business. We do have to give them a little bit of time to implement and give them a little bit of time and room to maneuver the way they think is the right to set us up for 2024 and beyond.

    是的。需要重申的一件事是,我們仍處於業務商業方面變革的早期階段。我們確實必須給他們一點時間來實施,並給他們一點時間和空間,讓他們按照他們認為正確的方式為 2024 年及以後做好準備。

  • Kevin R. Thornal - President, CEO & Director

    Kevin R. Thornal - President, CEO & Director

  • Yes, I'll just add into that Rod is that we had 2 of our largest training classes ever come through here in Redwood City over the last quarter. So those reps are getting out in the field, coming back in for additional training and then getting back out in the field to being able to get out there and do what salespeople do best.

    是的,我要補充一點的是,上個季度我們在雷德伍德城舉辦了兩期規模最大的訓練課程。因此,這些銷售代表要走出現場,回來接受額外的培訓,然後再回到現場,以便能夠走出去,做銷售人員最擅長的事情。

  • Bradley Thomas Bowers - Senior Associate

    Bradley Thomas Bowers - Senior Associate

  • Okay, great. And then just one quick follow-up here. You now have, I guess, all of the competitors in the PDN market with the final one getting their approval recently. So just wanted to give you the opportunity, now we don't have to worry about what's going to happen once those competitors are in the market. So how the conversations are going with the PDN salesforce and how Nevro is continuing to win those conversations.

    好的,太好了。然後這裡只是一個快速跟進。我想,現在 PDN 市場上的所有競爭對手都已經具備,最後一個競爭對手最近也獲得了批准。所以只是想給你機會,現在我們不必擔心一旦這些競爭對手進入市場會發生什麼事。那麼與 PDN 銷售人員的對話進展如何,以及 Nevro 如何繼續贏得這些對話。

  • Kevin R. Thornal - President, CEO & Director

    Kevin R. Thornal - President, CEO & Director

  • Yes. No problem. Thanks, Brad. Yes, we are still the only paresthesia free SCS player on the market, the only high frequency on the market. And as we've said all along, and it resonates with the endocrinologists that refer patients in to our implanting physicians, and it makes sense to our implanting physicians that you would desire paresthesia-free option for patients that are already experiencing numbness in their feet and their legs, why would you want to add even more to that, right?

    是的。沒問題。謝謝,布拉德。是的,我們仍然是市場上唯一無感覺異常的SCS播放器,市場上唯一的高頻。正如我們一直以來所說的,這引起了將患者轉診給我們的植入醫生的內分泌科醫生的共鳴,並且對於我們的植入醫生來說,您希望為已經出現腳部麻木的患者提供無感覺異常的選擇,這是有道理的還有他們的腿,你為什麼要添加更多,對吧?

  • So, the whole goal is to get up -- is to get people pain-free enough and ambulating so they can walk around. And when they walk around, obviously, then they're going to have better results in lowering their A1c and their body weight, which we have now data showing that the implanted patients with SCS 10-kilohertz high frequency, do reduce weight and A1c. And that's because, obviously, we don't know for sure the method of action, but we do know those patients get up and walk around, and we do have clinical results showing they do better. No one else has that kind of clinical data and no one else can do paresthesia-free high frequency. So we still feel very optimistic that we're going to continue to win there.

    所以,整個目標是站起來——讓人們足夠無痛地走動,這樣他們就可以四處走動。顯然,當他們四處走動時,他們在降低 A1c 和體重方面會有更好的效果,我們現在的數據顯示,植入 SCS 10 kHz 高頻的患者確實可以減輕體重和 A1c。這是因為,顯然,我們不確定具體的治療方法,但我們確實知道這些患者會站起來走動,而且我們確實有臨床結果表明他們的情況有所改善。沒有人擁有這樣的臨床數據,也沒有人可以做到無感覺異常的高頻。所以我們仍然對我們將繼續在那裡獲勝感到非常樂觀。

  • Now, I'll also say that in any type of medical devices that I've been in for well over 20 years, all companies do well when rising tides happen for all, right? So, I do think that having more players in the market to help educate and have increased the awareness is good for patients and good for implanting physicians as well.

    現在,我還要說,在我從事了 20 多年的任何類型的醫療設備中,當所有人都漲潮時,所有公司都會表現良好,對吧?因此,我確實認為市場上有更多的參與者來幫助教育並提高意識,這對患者有好處,對植入醫生也有好處。

  • Operator

    Operator

  • The next question is from William Plovanic with Canaccord Genuity.

    下一個問題來自 Canaccord Genuity 的 William Plovanic。

  • Caitlin Cronin - Associate

    Caitlin Cronin - Associate

  • Hi, this is Caitlin Cronin on for Bill Plovanic. Congrats on a good quarter. Just wondering, more broadly, to what extent you're seeing increased competition and share gains or losses from the private competitors in the market.

    大家好,我是比爾普洛瓦尼克 (Bill Plovanic) 的凱特琳克羅寧 (Caitlin Cronin)。恭喜季度表現良好。只是想知道,更廣泛地說,您在多大程度上看到競爭加劇並分享市場上私人競爭對手的收益或損失。

  • Kevin R. Thornal - President, CEO & Director

    Kevin R. Thornal - President, CEO & Director

  • Yes. We're really not seeing that much. We do look at a couple of the models that are out there. We do see some of the expected results that are there. We obviously still are the only high-frequency player in the market. I do believe that they're probably going after some of the other low frequency competitors that are out there.

    是的。我們確實沒有看到那麼多。我們確實研究了一些現有的模型。我們確實看到了一些預期的結果。顯然我們仍然是市場上唯一的高頻參與者。我確實相信他們可能會追趕其他一些低頻競爭對手。

  • And we continue on our path of explaining and using the clinical studies that we have to show the superiority of the paresthesia-free, high-frequency SCS. So, we're not thinking that we're losing share to any of those smaller players. And obviously, it doesn't mean we're not losing a few cases here or there, but we believe we held share in the quarter.

    我們繼續解釋和使用臨床研究,以證明無感覺異常、高頻 SCS 的優越性。因此,我們並不認為我們的市佔率會被那些規模較小的公司奪走。顯然,這並不意味著我們不會在這裡或那裡失去一些案件,但我們相信我們在本季度保持了份額。

  • Operator

    Operator

  • The next question is from Adam Maeder with Piper Sandler.

    下一個問題是 Adam Maeder 和 Piper Sandler 提出的。

  • Simran Kaur - Research Analyst

    Simran Kaur - Research Analyst

  • Hi, Kevin. Hi, Rod. This is Simran on for Adam. I just wanted to start off on a comment that you guys made on the HFX iQ launch. I think you said iQ represented 43% of implants in Q3. We're now over 6 months into the iQ launch. And I think previously, the team had said it would take 6 to 9 months for the launch to represent 75% to 80% of the mix. So, just any further color on how that launch has trended relative to your expectations? Any learnings that you can share from reps in the field?

    嗨,凱文。嗨,羅德。這是西姆蘭(Simran)為亞當(Adam)發言。我只是想從你們對 HFX iQ 發布的評論開始。我想你說過 iQ 佔第三季植入物的 43%。 iQ 發布至今已有 6 個多月了。我認為之前,團隊曾表示需要 6 到 9 個月的時間才能完成 75% 到 80% 的發布。那麼,關於這次發布的趨勢與您的預期相比,還有什麼進一步的看法嗎?您可以從該領域的代表分享什麼經驗教訓嗎?

  • Roderick H. MacLeod - Senior VP & CFO

    Roderick H. MacLeod - Senior VP & CFO

  • Yes, hi, Simran. This is Rod. Yes, so we're a touch behind the curve where we would have thought that we would be at this point. And there have been a couple of things that have impacted the launch, although we still continue to see a trajectory that is going up into the right. But as we mentioned before, we did -- as Kevin just mentioned, we had a large training class. We had some open territories and we're making the changes within the sales force to bring them up to speed, get the new folks trained. That probably had a little bit of an impact there.

    是的,嗨,西姆蘭。這是羅德。是的,所以我們有點落後於我們原本以為我們會在這一點上的情況。儘管我們仍然看到一條向右上升的軌跡,但有幾件事影響了發射。但正如我們之前提到的,我們做到了——正如凱文剛才提到的,我們舉辦了一個大型培訓課程。我們有一些開放的領域,我們正在銷售團隊中進行變革,讓他們跟上進度,對新員工進行培訓。這可能對那裡產生了一點影響。

  • Some of the larger contracts that took us a little bit longer to get on contract with those, but we had some pretty good successes in Q3 that we should start to see some of the results of that. And then, we also thought that we would be selling iQ internationally with BSI approval, and we're -- I think we're not the only ones in saying that we've had experienced some delays out of BSI on that. But that's certainly delayed -- that entering into the mix as well in terms of the iQ launch. But those are some of the bigger areas that have maybe slowed it down a little bit from where we thought we would be. But as I said, we are still continuing to go up that ramp.

    一些較大的合約讓我們花了更長的時間才與這些合約簽訂合同,但我們在第三季度取得了一些相當好的成功,我們應該開始看到其中的一些結果。然後,我們也認為我們將在獲得 BSI 批准的情況下在國際上銷售 iQ,而且我們——我認為我們並不是唯一說我們在這方面經歷過 BSI 延遲的人。但這肯定被推遲了——就 iQ 的發布而言,這也被推遲了。但這些更大的領域可能比我們想像的要慢一些。但正如我所說,我們仍在繼續走上坡道。

  • Simran Kaur - Research Analyst

    Simran Kaur - Research Analyst

  • Okay, very helpful. And just a quick follow-up on the initiatives that you guys have implemented regarding the sales force. I guess I just want to fully understand, are those initiatives completely implemented and digested? Or do you still have some open territories here and there that you kind of need to rightsize? And then, how should we think about the sales force over the remainder of the year and in 2024 in terms of size and productivity?

    好的,非常有幫助。快速跟進你們針對銷售人員所實施的措施。我想我只是想充分了解,這些措施是否得到了充分實施和消化?或者您仍然存在一些需要調整大小的開放區域?那麼,我們該如何考慮今年剩餘時間和 2024 年的銷售團隊規模和生產力?

  • Kevin R. Thornal - President, CEO & Director

    Kevin R. Thornal - President, CEO & Director

  • Yes, pretty much -- thanks for those questions. Pretty much the open territories are [onesie-twosies] at this point. We filled most of those the last couple of quarters. And as I said, they've been in and out of their training courses that have been here. So that's good.

    是的,非常感謝您提出這些問題。此時,幾乎所有開放區域都是[連體雙人]。我們在過去幾個季度填補了其中的大部分。正如我所說,他們已經進出這裡的培訓課程。所以這樣很好。

  • The implementation and the enhancement of the comp plan is all done. The reps have the numbers that they're marching towards to finish up their year as we head into the end of the year. And obviously, we'll continue to tweak everything as we head into 2024. But in large, everything that was the big initiatives are behind us and absorbed, and the team is running hard out in the field.

    補償計劃的實施和改進已經全部完成。當我們進入年底時,代表們已經完成了他們今年的目標。顯然,進入 2024 年,我們將繼續調整一切。但總的來說,所有重大舉措都已被我們拋在腦後並被吸收,團隊正在該領域努力奮鬥。

  • Operator

    Operator

  • The next question is from Robbie Marcus with J.P. Morgan.

    下一個問題來自摩根大通的羅比·馬庫斯。

  • Unidentified Analyst

    Unidentified Analyst

  • Hey, this is actually [Rohan] on for Robbie. Just a question on gross margin. It came in a bit softer in the quarter, and I was hoping you could just talk more about your expectations for fourth quarter in light of the HFX ramp and what a reasonable assumption is for margin expansion next year and longer term, given all the puts and takes from the legacy pricing HFX in Costa Rica?

    嘿,這實際上是為羅比準備的[Rohan]。只是一個關於毛利率的問題。本季的表現有點疲軟,我希望您能根據 HFX 的成長,更多地談談您對第四季度的預期,以及考慮到所有看跌期權,明年和更長期的利潤率擴張的合理假設是什麼並借鑒了哥斯達黎加HFX 的傳統定價?

  • Roderick H. MacLeod - Senior VP & CFO

    Roderick H. MacLeod - Senior VP & CFO

  • Yes. And you're hitting the -- this is Rod. Thanks for the question. You're hitting the 2 big things. We have a confluence of an iQ launch and a transfer of manufacturing to Costa Rica. And as we've talked about in the past, as iQ ramps, we also have pricing pressure on our legacy products. And in Q3, legacy products still represented over 50% of our mix. And as we've reported over the last couple of quarters and continuing into this quarter, continue to have some pricing pressure there.

    是的。你正在擊中——這是羅德。謝謝你的提問。你正在觸及兩件大事。我們將 iQ 的推出和製造轉移到哥斯達黎加結合起來。正如我們過去談到的,隨著 iQ 的提升,我們的傳統產品也面臨定價壓力。在第三季度,傳統產品仍然占我們產品組合的 50% 以上。正如我們在過去幾個季度和本季所報告的那樣,那裡繼續面臨一些定價壓力。

  • Similarly, as we are a little bit behind that curve as we answered in one of the previous questions and don't have that BSI approval to sell into Europe, our volumes are a little bit lower, which also means we have to continue to sell through contract manufactured products at a higher rate than we would have anticipated. So we kind of have the confluence of those 2 things happening in Q3, which obviously put some pressures on the margins, as you noted. That should -- we should get better. Going into Q4, our mix on iQ will improve. We will still have to sell some of our contract manufactured products in Q4. But over time, we do anticipate transitioning more and more to the Costa Rica sourced products, and that will certainly help margins.

    同樣,正如我們在之前的一個問題中回答的那樣,我們有點落後於曲線,並且沒有 BSI 批准向歐洲銷售,因此我們的銷量有點低,這也意味著我們必須繼續銷售通過合約製造產品的速度比我們預期的要高。因此,我們在第三季度發生了這兩件事,這顯然給利潤率帶來了一些壓力,正如您所指出的。那應該——我們應該變得更好。進入第四季度,我們的 iQ 組合將會有所改善。我們仍然需要在第四季度銷售一些合約製造的產品。但隨著時間的推移,我們確實預計將越來越多地轉向哥斯達黎加採購的產品,這肯定有助於提高利潤。

  • I would anticipate that -- we're not providing guidance for 2024, but we do expect that over time, we have a pathway still to kind of that mid 70s that we've talked about. It's just going to take a little bit of time in terms of us getting there both from a cost and a price perspective.

    我預計,我們不會提供 2024 年的指導,但我們確實預計,隨著時間的推移,我們仍然有一條通往我們所討論的 70 年代中期的道路。從成本和價格的角度來看,我們需要一點時間才能實現這一目標。

  • Unidentified Analyst

    Unidentified Analyst

  • Great. That was super helpful. I just had a quick follow-up on PDN. And apologies if someone may have already touched on this, but are you seeing any competitive pressures here specifically? And do you have any thoughts qualitative on 2024 and your expectations for the market as well as competition next year?

    偉大的。這非常有幫助。我剛剛在 PDN 上進行了快速跟進。如果有人可能已經觸及這一點,我深表歉意,但您是否特別看到這裡有任何競爭壓力?您對2024年有什麼定性的想法以及對明年的市場和競爭的期望嗎?

  • Kevin R. Thornal - President, CEO & Director

    Kevin R. Thornal - President, CEO & Director

  • Yes. So we did answer the PDN one, but I'll just wrap it up again. Yes, we do know that all of our competitors have indications. However, that's obviously FDA approval. You still need to have clinical studies to show to doctors to convince them to try that, and that's continually where we are the only company that has a large RCT that's out there that shows the benefits of high-frequency, paresthesia-free.

    是的。我們確實回答了 PDN 問題,但我將再次總結一下。是的,我們確實知道我們所有的競爭對手都有跡象。然而,這顯然是 FDA 的批准。你仍然需要向醫生展示臨床研究,說服他們嘗試這一點,而我們一直是唯一一家擁有大型隨機對照試驗的公司,該試驗顯示了高頻、無感覺異常的好處。

  • And like I said just earlier before, why would you want to put a patient into paresthesia who is already experiencing numbness and tingling in their legs? So, we feel very confident about our leadership there in PDN, and we talk about it every day. And I use the word moral obligation or the words moral obligation because we know when we win, that means patients get the best therapy that's been clinically proven in the PDN space.

    就像我之前說過的,為什麼要讓一個腿部已經麻木和刺痛的病人進入感覺異常?因此,我們對 PDN 的領導地位非常有信心,我們每天都會談論這一點。我使用「道德義務」一詞或「道德義務」一詞是因為我們知道,當我們獲勝時,這意味著患者可以獲得 PDN 領域臨床證明的最佳治療。

  • So, we feel good that we'll continue to maintain our leadership there. We are -- it is a benefit to have other competitors in this space because all boats rise with the rising tide, of course. So that will help from an education standpoint. And on the 2024, we're just -- we're a month into Q4, so we need to get a few more months underneath our belt and the transition with our commercial teams before we provide anything for 2024. So we're not going to provide any guidance at this time.

    因此,我們很高興我們將繼續保持在那裡的領導地位。我們——在這個領域有其他競爭對手是有好處的,因為當然,所有的船都會隨著潮水的上漲而上升。因此,從教育的角度來看,這將有所幫助。就 2024 年而言,我們距離第四季度還有一個月的時間,因此我們需要再花幾個月的時間與商業團隊進行過渡,然後才能為 2024 年提供任何服務。所以我們不會此時將提供任何指導。

  • Operator

    Operator

  • The next question is from Richard Newitter with Truist Securities.

    下一個問題來自 Truist Securities 的 Richard Newitter。

  • Samuel E. Brodovsky - Associate

    Samuel E. Brodovsky - Associate

  • This is Sam on for Rich. Just quick one, just to follow-up on gross margin there. And I know we're not going to provide guidance for '24 yet. But just directionally, is there any way you could speak to, with all those moving parts going forward and hopefully getting resolved, should '24 on a quarter-to-quarter basis, see better gross margin than 4Q? Can 4Q basically be a taking off point for gross margin next year?

    這是山姆為里奇辯護的人。只是快一點,只是為了跟進那裡的毛利率。我知道我們還不會為 '24 提供指導。但就方向而言,隨著所有這些活動的進展並希望得到解決,您有什麼辦法可以談談,24 年按季度計算的毛利率應該比第四季度更好嗎?明年4Q基本上可以成為毛利率的起飛點嗎?

  • Roderick H. MacLeod - Senior VP & CFO

    Roderick H. MacLeod - Senior VP & CFO

  • Yes. Appreciate the question, but like I said, we're not providing guidance into '24 for the full year, let alone for quarters at this point. What I will say, though, is that we continue to be excited about the costs that are coming out of our Costa Rica plant, and we believe that we've got a good pathway to continue to drive those costs down, and that should help with margins. And as we do move forward, we anticipate that we'll receive pricing benefit from our iQ product as that mix increases. So, not going to get a whole lot more granular than that at this point, but that's the sort of color that we can provide at this time.

    是的。感謝這個問題,但就像我說的,我們不會提供 24 週年的全年指導,更不用說目前的季度指導了。不過,我要說的是,我們仍然對哥斯達黎加工廠的成本感到興奮,我們相信我們有一個很好的途徑來繼續降低這些成本,這應該會有所幫助有邊距。隨著我們向前邁進,我們預計隨著產品組合的增加,我們將從 iQ 產品中獲得定價優勢。因此,目前不會得到比這更細粒度的顏色,但這就是我們目前可以提供的顏色。

  • Samuel E. Brodovsky - Associate

    Samuel E. Brodovsky - Associate

  • Great, that's helpful. And then just a more qualitative one. As we think about maybe some of the regions where the commercial structure was more just realigned as opposed to having turnover in the sales force. Can you give us any color as to what the performance in 3Q will look like for those regions versus some of the ones where there was more disruption?

    太好了,很有幫助。然後是一個更定性的。正如我們所想,也許在某些地區,商業結構只是重新調整,而不是銷售團隊的流動。您能否告訴我們這些地區與一些中斷較多的地區在第三季的表現如何?

  • Kevin R. Thornal - President, CEO & Director

    Kevin R. Thornal - President, CEO & Director

  • Yes. I don't think we'll get into territory by territory, but I'll just say, in general, we feel really great about the -- bringing Greg in and ensuring that we have A+ talent at every single position, whether that's someone who's been here for 10 years or 10 days. The expectations for our sales organization is extremely high. The bar to get in is extremely high. And once here, the expectations continue to be extremely high.

    是的。我不認為我們會逐個領域進入,但我只想說,總的來說,我們對引進格雷格並確保我們在每個職位上都擁有 A+ 人才感到非常高興,無論是某人誰已經在這裡呆了10年或10天了。對我們銷售組織的期望非常高。進入的門檻非常高。一旦來到這裡,人們的期望仍然非常高。

  • And so, a typical turnover in med device that's highly competitive would be 10% to 20%. And we definitely -- we're in that range previously. With our enhanced comp plan, with the alignment of the teams that we have closer to the customer, working together with the management responsibilities occurring closer to the customer and giving power to those that are closest to the customer, we're seeing not only pockets, but obviously, our expectations for this quarter, we did better than what we would have thought.

    因此,競爭激烈的醫療器材的典型營業額為 10% 到 20%。我們肯定——我們之前就在這個範圍內。透過我們增強的薪酬計劃,透過與我們更接近客戶的團隊進行協調,與更接近客戶的管理職責一起工作,並將權力交給那些最接近客戶的人,我們看到的不僅僅是口袋但顯然,我們對本季的預期,我們做得比我們想像的要好。

  • So, while we're not declaring victory, I do like where we're going. We have another quarter here that is absorbing some of these changes, but I feel good about Greg and his team and what they've done to be able to set us up for success, not only for this quarter, but also really as we head into 2024.

    因此,雖然我們沒有宣布勝利,但我確實喜歡我們的前進方向。我們還有一個季度正在吸收其中的一些變化,但我對格雷格和他的團隊以及他們為使我們取得成功所做的一切感到滿意,不僅是本季度的成功,而且是我們前進的方向到2024年。

  • Operator

    Operator

  • There are no further questions at this time. We'll turn it back to the presenters. My apologies, we do have one more question from Dave Turkaly with JMP Securities.

    目前沒有其他問題。我們會將其轉回給演示者。抱歉,我們還有 JMP 證券戴夫圖卡利 (Dave Turkaly) 提出的一個問題。

  • David Louis Turkaly - MD & Equity Research Analyst

    David Louis Turkaly - MD & Equity Research Analyst

  • Kevin, I might just want to press a little bit on the M&A side. Do you think you'd stay focused on the core pain markets or are you open to other areas, let's say, in the neuromod or bioelectronic medicine arena?

    凱文,我可能只是想在併購方面稍微強調一下。您認為您會繼續專注於核心疼痛市場,還是對其他領域持開放態度,例如神經調節或生物電子醫學領域?

  • Kevin R. Thornal - President, CEO & Director

    Kevin R. Thornal - President, CEO & Director

  • Yes, thanks, Dave. Great question. As I alluded to in the prepared remarks, the biggest asset we have in this organization, outside of our technology, our biggest expense is our sales force. And what we want to do is ensure that we keep them focused on the same call points where they're headed today.

    是的,謝謝,戴夫。很好的問題。正如我在準備好的發言中提到的,我們在這個組織中擁有的最大資產,除了我們的技術之外,我們最大的支出是我們的銷售團隊。我們想要做的是確保我們讓他們專注於他們今天要去的相同呼叫點。

  • The last thing we wanted to do is add more places they have to go to new doctors they don't already know. So the focus has been on dropping something into the bag that they can leverage those relationships they already have and spend more time at each of those locations before getting in the car and spending windshield time between the next physician.

    我們最不想做的就是增加更多他們必須去不認識的新醫生那裡就診的地方。因此,重點是把一些東西放進包包裡,這樣他們就可以利用他們已經擁有的關係,在上車之前在每個地點花更多的時間,並在下一位醫生之間度過擋風玻璃的時間。

  • I'd just say it a little bit more clearly, what would be great is each of our sales reps, when they show up at a physician's office in the morning, can look at the staff and say, "Boy, this is going to be a great morning. I'll be with you all morning doing XYZ procedures with you, and then we'll have lunch and then I'll head on to the next place," versus bouncing from one SCS case to another doctor to doctor, right? I mean, our sales force whenever they're in front of a windshield, they're not in front of a customer or in front of a patient. And so leveraging the sales force and dropping something to the call point they already have is the #1 priority and the targets that we're looking at.

    我只想說得更清楚一點,最好的是我們的每個銷售代表早上出現在醫生辦公室時,可以看著工作人員說:「男孩,這將是一個美好的早晨。整個早上我都會和你一起做XYZ 手術,然後我們吃午飯,然後我會前往下一個地方,」而不是從一個SCS 病例跳到另一個醫生到另一個醫生, 正確的?我的意思是,我們的銷售人員只要站在擋風玻璃前,他們就不是在客戶或病人面前。因此,利用銷售隊伍並將某些東西放到他們已有的呼叫點是第一要務,也是我們正在考慮的目標。

  • David Louis Turkaly - MD & Equity Research Analyst

    David Louis Turkaly - MD & Equity Research Analyst

  • Got it. And one quick follow-up on the GLP. I mean, it sounds like you literally said that you expect 0 impact and that -- and I think I heard that and that many of your patients in the trial were already on it. I mean is that like half or could you provide like a percent there? And did I hear that correctly?

    知道了。以及 GLP 的快速跟進。我的意思是,聽起來你確實說過你期望零影響,而且我想我聽說了這一點,並且試驗中的許多患者已經接受了治療。我的意思是,大約是一半還是您能提供大約百分比嗎?我沒聽錯嗎?

  • Kevin R. Thornal - President, CEO & Director

    Kevin R. Thornal - President, CEO & Director

  • Yes. So, yes, I will provide -- it's about 1/3 -- a little less than 1/3 of the patients in the PDN study were already on GLP-1s or the class of drugs. And so, they obviously have been on those for years. I mean, it's not a new drug, so they've been on those for years, and they still met the inclusion criteria; that meant they had painful diabetic neuropathy despite taking those drugs. So that's what gives us the confidence.

    是的。所以,是的,我會提供——大約 1/3——略低於 1/3 的 PDN 研究中的患者已經在服用 GLP-1 或此類藥物。因此,他們顯然多年來一直致力於這些。我的意思是,這不是一種新藥,所以他們已經使用這些藥物多年了,而且仍然符合納入標準;這意味著儘管服用了這些藥物,他們還是患有痛苦的糖尿病神經病變。這就是給我們信心的原因。

  • And then, I'll reiterate in the prepared remarks as well, I mean, we are in the very, very early innings. We're probably still in batting practice in the full launch of PDN with 2 million to 3 million patients. And obviously, you can do the math. I mean, we're very, very little penetration. So, even if a big portion of that market happened to go away, we're still well within our ability to grow for a really long period of time.

    然後,我也會在準備好的發言中重申,我的意思是,我們正處於非常非常早期的階段。我們可能仍處於 PDN 全面推出、面向 200 萬至 300 萬患者的練習階段。顯然,你可以計算一下。我的意思是,我們的滲透率非常非常低。因此,即使該市場的很大一部分碰巧消失,我們仍然有能力在很長一段時間內實現成長。

  • But the confidence is not only the patients who were already in our PDN study that still had the benefit and had great results, but also, we obviously talked with some of the top leading endocrinologists in the world that are part of our KOL, key opinion leader group. And so we take the guidance from them as well because they're the experts to see the patients every day.

    但我們的信心不僅在於那些已經參與我們的 PDN 研究的患者仍然受益並取得了良好的結果,而且我們顯然與一些世界頂級內分泌學家進行了交談,他們是我們 KOL 的一部分,關鍵意見領導小組。因此,我們也接受他們的指導,因為他們是每天為患者看診的專家。

  • Operator

    Operator

  • The next question is from Rich Newitter with Truist. Rich Newitter with Truist, your line is open. Okay, it appears that there are no further questions. I'll turn it back to the presenters for any closing remarks.

    下一個問題來自 Rich Newitter 和 Truist。 Rich Newitter 與 Truist,您的線路已開通。好吧,看來沒有其他問題了。我會將其轉回給主持人以供結束語。

  • Kevin R. Thornal - President, CEO & Director

    Kevin R. Thornal - President, CEO & Director

  • All right. Thank you, operator. Appreciate it. And thanks, everyone, for joining us today, and I look forward to reporting on our progress on our next call. Talk to everyone soon. Thank you.

    好的。謝謝你,接線生。欣賞它。感謝大家今天加入我們,我期待在下次電話會議上報告我們的進展。快和大家聊聊吧。謝謝。

  • Operator

    Operator

  • Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

    女士們、先生們,今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。