Shockwave Medical Inc (SWAV) 2023 Q2 法說會逐字稿

Good afternoon, and welcome to Shockwave's Second Quarter 2023 Earnings Conference Call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host, Debbie Kaster, Vice President of Investor Relations at Shockwave, for a few introductory comments.

下午好，歡迎參加 Shockwave 2023 年第二季度收益電話會議。 （操作員說明）謹此提醒，此通話正在錄音以供重播之用。現在我想將電話轉給主持人 Shockwave 投資者關係副總裁黛比·卡斯特 (Debbie Kaster)，請其發表一些介紹性評論。

Thank you all for participating in today's call. Joining me today from Shockwave Medical are Doug Godshall, President and Chief Executive Officer; Isaac Zacharias, President and Chief Commercial Officer; and Dan Puckett, Chief Financial Officer. Earlier today, Shockwave released financial results for the quarter ended June 30, 2023. A copy of the press release is available on Shockwave's website.

感謝大家參加今天的電話會議。今天與我一起參加 Shockwave Medical 的還有總裁兼首席執行官 Doug Godshall；艾薩克·扎卡里亞斯 (Isaac Zacharias)，總裁兼首席商務官；和首席財務官 Dan Puckett。今天早些時候，Shockwave 發布了截至 2023 年 6 月 30 日的季度財務業績。該新聞稿的副本可在 Shockwave 網站上獲取。

Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call other than the statement of historical fact are forward-looking statements. All forward-looking statements, including, without limitation, statements relating to our sales and operating trends, business and hiring prospects, financial and revenue expectations, reimbursement proposals, future product development and approvals and the integration of Neovasc and its technologies into our business are based upon our current estimates and various assumptions.

在我們開始之前，我想提醒您，管理層將在本次電話會議期間發表聲明，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明是根據1995 年《私人證券訴訟改革法案》的安全港條款制定的除歷史事實陳述外，本次電話會議中包含的任何陳述均為前瞻性陳述。所有前瞻性陳述，包括但不限於與我們的銷售和運營趨勢、業務和招聘前景、財務和收入預期、報銷建議、未來產品開發和批准以及Neovasc 及其技術與我們業務的整合有關的陳述，均屬於前瞻性陳述。基於我們當前的估計和各種假設。

These statements involve material risks and uncertainties, including the impact of macroeconomic conditions and global events such as the COVID-19 pandemic that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our annual report on Form 10-K on file with the SEC and available on EDGAR and in our other reports filed periodically with the SEC. Shockwave disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 7, 2023.

這些陳述涉及重大風險和不確定性，包括宏觀經濟狀況和 COVID-19 大流行等全球事件的影響，可能導致實際結果或事件與這些前瞻性陳述的預期或暗示存在重大差異。因此，您不應過分依賴這些陳述。有關與我們業務相關的風險和不確定性的列表和描述，請參閱我們向SEC 存檔的10-K 表格年度報告中的風險因素部分，該報告可在EDGAR 上獲取，以及我們定期向SEC 提交的其他報告。除法律要求外，Shockwave 不承擔任何更新或修改任何財務預測或前瞻性陳述的意圖或義務，無論是由於新信息、未來事件還是其他原因。本次電話會議包含時效性信息，僅截至今天（2023 年 8 月 7 日）直播時準確。

And with that, I'll turn the call over to Doug.

然後，我會將電話轉給道格。

Thanks, Debbie. Good afternoon, everyone, and thank you for taking the time to join us to review Shockwave's results for the second quarter of 2023. Our businesses continue to experience solid growth across the board in the U.S. and internationally in both peripheral and coronary franchises. Second quarter revenues of $180.2 million represented a 49% increase from the second quarter of 2022. We're pleased with the continued acceptance and penetration of our products and are particularly encouraged by the traction we've seen with our 2 newly released lease products, the L6 peripheral product in the U.S. and the C2+ coronary product internationally. In both cases, the enhanced capabilities of these new designs have resonated with customers are a testament to the ability of our organization to understand customer needs and work together efficiently to design and launch products that successfully address those needs.

謝謝，黛比。大家下午好，感謝您抽出時間與我們一起回顧 Shockwave 2023 年第二季度的業績。我們的業務在美國和國際外圍及冠狀動脈特許經營業務中繼續全面穩健增長。第二季度收入為 1.802 億美元，較 2022 年第二季度增長 49%。我們對我們產品的持續接受和滲透感到高興，尤其對我們新發布的 2 款租賃產品的吸引力感到鼓舞，美國的L6外周產品和國際的C2+ 冠狀動脈產品。在這兩種情況下，這些新設計的增強功能都引起了客戶的共鳴，這證明了我們的組織有能力了解客戶需求並有效地合作設計和推出成功滿足這些需求的產品。

This past quarter, we closed our acquisition of Neovasc and we quickly got to work integrating the Reducer product and team into Shockwave. The lean resource profile and creative financing structure at Neovasc made for a complex integration process and was a heavy workload for our team, but they did a stellar job on our first such project together and proved they were up to the top.

上個季度，我們完成了對 Neovasc 的收購，並迅速開始將Reducer 產品和團隊集成到 Shockwave 中。 Neovasc 精益的資源配置和創造性的融資結構導致了一個複雜的整合過程，給我們的團隊帶來了繁重的工作量，但他們在我們的第一個此類項目中表現出色，並證明了他們的能力。

Over the last few months, we have begun to infuse additional resources into the Reducer program, which we are confident will help up-regulate performance and execution. Much of the future value of Reducer hinges on clinical data generation, particularly the COSIRA II Study, we have overhauled the approach to clinical operations and are adding resources to existing -- to the existing team, which should lead to a tightly executed study as we have become accustomed to a Shockwave.

在過去的幾個月裡，我們已經開始向Reducer 計劃注入額外的資源，我們相信這將有助於提高性能和執行力。 Reducer 的未來價值很大程度上取決於臨床數據生成，特別是 COSIRA II 研究，我們已經徹底修改了臨床操作方法，並向現有團隊添加資源，這應該會導致一項嚴格執行的研究，因為我們已經習慣了衝擊波。

Our principal focus right now will be to activate more sites since having more shots on goal is a critical component of enrollment. As a reminder, COSIRA II is a sham-controlled, double-blind, randomized IDE trial to evaluate the Reducer system for safety and effectiveness in patients with refractory angina due to obstructive coronary disease that is not amenable to conventional revascularization.

我們現在的主要重點是激活更多站點，因為更多射門次數是註冊的關鍵組成部分。提醒一下，COSIRA II 是一項假對照、雙盲、隨機IDE 試驗，旨在評估Decreer 系統對因阻塞性冠狀動脈疾病（不適合常規血運重建）導致的難治性心絞痛患者的安全性和有效性。

The study will include approximately 380 patients in up to 50 centers. The primary endpoint is change in exercise tolerance testing time. Now that we have begun to get our arms around the clinical and regulatory program, we are projecting U.S. approval in 2027.

該研究將包括多達 50 個中心的約 380 名患者。主要終點是運動耐量測試時間的變化。現在我們已經開始著手臨床和監管計劃，預計 2027 年獲得美國批准。

Sticking with the subject of the Reducer for the moment, the energy we saw around this product at EuroPCR was rather remarkable as evidenced by a standing room only symposium in multiple very well-attended training sessions. The strong global interest in Reducer has us even more enthusiastic about this acquisition and further increases our confidence the Reducer is well positioned to address a significant unmet need and has great attention to becoming a meaningful contributor to our business once COSIRA II data is available.

暫時先討論一下Reducer 的主題，我們在 EuroPCR 上看到的圍繞該產品的能量是相當引人注目的，這一點可以從多次參加人數眾多的培訓課程中只有站著的研討會上得到證明。全球對Reducer 的濃厚興趣使我們對此次收購更加熱情，並進一步增強了我們的信心，Reducer 能夠很好地解決未滿足的重大需求，並且一旦COSIRA II 數據可用，我們將高度重視成為我們業務的有意義的貢獻者。

EuroPCR was a fantastic conference for us across the board. Many of our customers referred to it as the Shockwave Congress. We had our official international launch at C2+ and at the same time, we celebrated the 5-year anniversary of our initial commercial launch of coronary IVL at PCR 2018.

EuroPCR 對我們來說都是一次精彩的會議。我們的許多客戶將其稱為衝擊波大會。我們在 C2+ 上正式進行了國際發布，同時，我們在 PCR 2018 上慶祝了冠狀動脈 IVL 首次商業發布 5 週年。

The IVL presentations at PCR consistently highlighted the outcomes achieved with IVL in real-world environments, including data presented from the Lilly and [Replica] registries from France and Spain, respectively. That together included almost 1,000 patients and strongly reinforced the safety and efficacy of coronary IVL.

PCR 上的 IVL 演示始終強調 IVL 在現實環境中取得的成果，包括分別來自禮來公司和法國和西班牙的[複製品]註冊中心提供的數據。這總共包括近 1,000 名患者，有力地增強了冠狀​​動脈 IVL 的安全性和有效性。

It is remarkable that in just 5 years, we have transitioned from IVL being a relative unknown to becoming a standard of care. The follow includes several strong conferences for Shockwave, and we are particularly looking forward to TCT in October in San Francisco, where we have many events, including several symposia, more real-world evidence and one of our favorite events, the top shock competition, which will focus on best practices with IVL in decentric and nodular calcium. We had roughly 100 commissions from our global customers this year.

值得注意的是，在短短 5 年的時間裡，我們已經從相對陌生的 IVL 轉變為一種護理標準。以下包括幾個有關Shockwave 的強大會議，我們特別期待10 月份在舊金山舉行的TCT，在那裡我們有很多活動，包括幾次研討會、更多真實世界的證據以及我們最喜歡的活動之一，頂級Shock 競賽，重點關注 IVL 在偏心鈣和結節鈣方面的最佳實踐。今年我們從全球客戶那裡獲得了大約 100 個佣金。

And of course, we're looking forward to the U.S. launch of C2+ TCT and to our Investor Innovation Day on October 23. Our IVL clinical work continues to ramp up after a quieter 2022, and last quarter, we were pleased to announce the first enrollment in our groundbreaking EMPOWER study, which is the first of its kind, all female study, assessing the performance of IVL in a population that is almost always underrepresented in cardiovascular research.

當然，我們期待著C2+ TCT 在美國的推出以及10 月23 日的投資者創新日。在經歷了平靜的2022 年之後，我們的IVL 臨床工作繼續加速，上個季度，我們很高興地宣布了第一個我們開創性的 EMPOWER 研究的入組人數，這是此類研究中的第一個，所有女性研究，評估 IVL 在心血管研究中幾乎總是代表性不足的人群中的表現。

Our BTK study is enrolling at a healthy pace, and we anticipate the last patient will be enrolled by the middle of 2024. We have a full pipeline of other studies in the very near future, which we will discuss at our Innovation Day. Overall, our investment in IVL clinical studies will be roughly 50% higher in the second half of this year than it was at the same period last year.

我們的 BTK 研究正在以健康的速度招募，我們預計最後一名患者將在 2024 年中期招募。在不久的將來，我們將進行一系列其他研究，我們將在創新日討論這些研究。總體而言，今年下半年我們對IVL臨床研究的投入將比去年同期增加約50%。

Regarding U.S. reimbursement, we continue to make great progress and are very encouraged by how we see CMS transitioning coronary IVL from temporary innovation programs like the NTAP to more permanent reimbursement structures such as those -- as those programs conclude. As you may recall, the duration of the NTAP program for coronary IVL is 2 years and is set to expire on September 30, at the end of CMS's fiscal year.

關於美國的報銷，我們繼續取得巨大進展，並且我們對 CMS 如何將冠狀動脈 IVL 從 NTAP 等臨時創新計劃轉變為更永久的報銷結構（如這些計劃的結論）感到非常鼓舞。您可能還記得，冠狀動脈 IVL 的 NTAP 計劃的持續時間為 2 年，將於 CMS 財政年度結束時的 9 月 30 日到期。

Consistent with their procedures, CMS analyzed the relevant data collected on coronary IVL under the NTAP program in order to determine how to best structure and pay for coronary IVL going forward. In April, CMS proposed the creating 3 new MS-DRG for coronary IVL as being the most appropriate long-term structure coming out of NTAP. We are extremely pleased to see that the final inpatient rule issued last week confirmed the creation of the 3 new DRGs for coronary IVL. This is a watershed event because this is the first time CMS has created new DRGs in the field of PCI in over 20 years. We think this is good for the field of interventional cardiology and for patients suffering from complex calcified coronary artery disease.

按照他們的程序，CMS 分析了 NTAP 計劃下收集的冠狀動脈 IVL 的相關數據，以確定如何最好地構建和支付未來冠狀動脈 IVL 的費用。 4 月份，CMS 提議為冠狀動脈 IVL 創建 3 個新的 MS-DRG，這是 NTAP 中最合適的長期結構。我們非常高興地看到上週發布的最終住院規則確認了為冠狀動脈 IVL 創建 3 個新的 DRG。這是一個分水嶺事件，因為這是 20 多年來 CMS 首次在 PCI 領域創建新的 DRG。我們認為這對於介入心髒病學領域和患有復雜鈣化冠狀動脈疾病的患者來說是有好處的。

The new DRGs capture the use of coronary IVL whether it's with or without a stent. The vast majority of coronary IVL cases involve a stent implantation. So I'd like to focus on those DRGs, which will pay on average $20,785 to $28,987 if major complications or comorbidities are present. For comparison, the other PCI DRGs involving stent implantation without IVL, we'll pay $12,767 and $20,187 respectively.

新的 DRG 捕獲了冠狀動脈 IVL 的使用，無論是否有支架。絕大多數冠狀動脈 IVL 病例涉及支架植入。因此，我想重點關注那些 DRG，如果存在重大並發症或合併症，平均將支付 20,785 至 28,987 美元。相比之下，其他涉及不帶 IVL 的支架植入的 PCI DRG，我們將分別支付 12,767 美元和 20,187 美元。

So in summary, effective October 1, 2023, payments for coronary IVL in the new DRG structure will be approximately $8,000 more than the non IVL PCI procedures and $4,000 more than was paid by the NTAP program. We believe this will help alleviate economic pressure on hospitals and enable physicians to make the best clinical decision for their patients.

總之，自 2023 年 10 月 1 日起，新 DRG 結構中的冠狀動脈 IVL 支付費用將比非 IVL PCI 手術多出約 8,000 美元，比 NTAP 計劃多出 4,000 美元。我們相信這將有助於減輕醫院的經濟壓力，並使醫生能夠為患者做出最佳的臨床決策。

On the hospital outpatient front, the transitional pass-through program will continue through June 30, 2024. And while CMS has not given any early signs of how they plan to transition from temporary or permanent, we remain very optimistic about our prospects of landing in the highest APC. As you have seen in the hospital inpatient side with the conclusion of the coronary IVL NTAP, CMS follows the process, and we remain confident in what we are seeing from the data.

在醫院門診方面，過渡性轉遞計劃將持續到 2024 年 6 月 30 日。雖然 CMS 尚未給出任何早期跡象表明他們計劃如何從臨時或永久過渡，但我們對落地的前景仍然非常樂觀最高的APC 。正如您在醫院住院部看到的冠狀動脈 IVL NTAP 的結論，CMS 遵循該流程，我們對從數據中看到的結果仍然充滿信心。

To date, additional remuneration for physicians, be it professional fees or RVUs have not been available for any of our therapies. We are excited to report that this will change as of January -- at January 1, 2024, when a new Category I CPT add-on code will go into effect. We will not know the amount that physicians will receive starting in 2024 until the final calendar year 2024 physician fee schedule is released in November. We are pleased with CMS' 2024 draft schedule issued last month which proposed up to 30% additional remuneration for physicians when coronary IVL is performed.

迄今為止，我們的任何療法都沒有向醫生提供額外報酬，無論是專業費用還是 RVU。我們很高興地報告，這一情況將從 2024 年 1 月 1 日起發生變化，屆時新的 I 類 CPT 附加代碼將生效。在 11 月發布 2024 年最終醫生費用表之前，我們無法得知從 2024 年開始醫生將收到的金額。我們對 CMS 上個月發布的 2024 年時間表草案感到滿意，該草案提議在進行冠狀動脈 IVL 時為醫生提供高達 30% 的額外報酬。

Turning now to operations. We continue to make significant investments to support and sustain our growth. We are accelerating our investment in Costa Rica, where we have a strong leadership team in place and have hired over 50 employees, many of whom are spending significant time in Santa Clara for training to ensure that the new site starts operating at a high level for day 1. Based on our global momentum and pipeline, we believe we will need even more capacity in the future than our combined Santa Clara and Costa Rica facilities will be able to provide, so we have exercised an option for a second phase in Costa Rica earlier than we had initially planned, which will nearly triple our clean room space there by 2025.

現在轉向運營。我們繼續進行大量投資以支持和維持我們的增長。我們正在加快在哥斯達黎加的投資，我們在哥斯達黎加擁有強大的領導團隊，並僱傭了 50 多名員工，其中許多人在聖克拉拉花費了大量時間接受培訓，以確保新工廠開始高水平運營。第一天。基於我們的全球勢頭和管道，我們相信未來我們將需要比聖克拉拉和哥斯達黎加聯合設施所能提供的更多的產能，因此我們選擇在哥斯達黎加進行第二階段比我們最初計劃的要早，到2025 年，我們的潔淨室空間將增加近兩倍。

Our strategy of using Costa Rica as our primary production location and Santa Clara as our innovation center is coming to fruition as we had hoped. Our intention is to develop new designs and therapies in Santa Clara, pilot them to optimize processes and then transfer most of them to Costa Rica in order to make room for the next wave of innovations. Next year, we're anticipating having 7 products in pilot production, which is a considerable step up and would once again leave us out of space. So we have also exercised an option on a fourth building in Santa Clara, which we will occupy towards the middle of next year.

我們利用哥斯達黎加作為我們的主要生產基地和聖克拉拉作為我們的創新中心的戰略正在如我們所希望的那樣取得成果。我們的目的是在聖克拉拉開發新的設計和療法，進行試點以優化流程，然後將其中大部分轉移到哥斯達黎加，以便為下一波創新騰出空間。明年，我們預計將有 7 種產品進入試生產，這是一個相當大的進步，但我們將再次陷入困境。因此，我們還對聖克拉拉的第四棟大樓行使了選擇權，我們將在明年年中入住。

We are fortunate that we have the bandwidth and financial wherewithal to expand our commercial footprint, continue ramping R&D and clinical activities, forward to invest in a high-quality margin expanding production facility and layer in a very promising future growth stimulus and reducer. These investments should bear fruit for years to come. We now anticipate top line revenue in the range of $725 million to $730 million for the full year of 2023. Representing growth of 48% to 49% from 2022. This number includes less than $5 million of Reducer sales for the full year of 2023.

我們很幸運，我們擁有足夠的帶寬和財力來擴大我們的商業足跡，繼續加大研發和臨床活動，投資於高質量的利潤擴大生產設施，並在非常有前途的未來增長刺激和減速器中進行投資。這些投資應該會在未來幾年取得成果。目前，我們預計2023 年全年的營收將在7.25 億美元至7.3 億美元之間。較2022 年增長48% 至49%。這一數字包括2023 年全年不到500 萬美元的減速器銷售額。

With that, I will turn the call over to Isaac to provide more detail on the commercial front. Isaac?

這樣，我會將電話轉給艾薩克，以提供有關商業方面的更多詳細信息。艾薩克？

Thank you, Doug. I am pleased with the team's efforts and results in Q2. Our U.S. peripheral business grew 13% sequentially from Q1 and 65% compared to the prior year, driven by increased usage across all sizes of catheters and strength from our newly launched L6 catheter. We were pleased to be able to showcase the L6 at several conferences, including multiple live cases in the quarter, which generated a lot of energy and enthusiasm. Customers love the device and the power profile of L6 and see it as the ideal treatment for iliac and large common femoral arteries. Our customers believe L6 provides improved angiographic results due to larger sizes and power profile.

謝謝你，道格。我對團隊在第二季度的努力和成果感到滿意。由於各種尺寸導管的使用量增加以及我們新推出的 L6 導管的強度增加，我們的美國外周血管業務比第一季度連續增長 13%，與上一年相比增長 65%。我們很高興能夠在多個會議上展示 L6，包括本季度的多個現場案例，這產生了很大的能量和熱情。客戶喜歡該設備和 L6 的功率曲線，並將其視為治療髂動脈和大股總動脈的理想方法。我們的客戶相信，L6 由於尺寸更大、功率分佈更佳，可以提供更好的血管造影結果。

During the quarter, we launched L6 in more than half of our peripheral accounts and we are seeing solid reorder patterns. We're also encouraged that approximately 2/3 of the L6 sales were in the 9, 10 and 12-millimeter sizes. These are cases that would likely have not been IVL cases with the 8-millimeter M5+. We plan to get the vast majority of our remaining peripheral customers launched on L6 in Q3.

在本季度，我們在超過一半的外圍設備帳戶中推出了 L6，並且我們看到了可靠的重新訂購模式。令我們感到鼓舞的是，大約 2/3 的 L6 銷量是 9、10 和 12 毫米尺寸。這些箱子很可能不是使用 8 毫米 M5+ 的 IVL 箱子。我們計劃在第三季度讓絕大多數剩餘的外圍設備客戶在 L6 上推出。

U.S. coronary revenue grew 9% sequentially from Q1 and 37% compared to the prior year driven primarily by increased penetration in our existing accounts as we continue to see healthy same-store sales growth. Nearly all of our revenue in Q2 came from accounts that were open in prior quarters. While new account growth has slowed, units per account are increasing, and we are seeing solid growth in high-volume accounts. We are on plan to grow the U.S. sales force to over 110 territories by the end of this year, and we'll have about 2 clinical specialists per territory.

美國冠狀動脈收入比第一季度連續增長 9%，比上一年增長 37%，這主要是由於我們繼續看到健康的同店銷售增長，從而提高了現有客戶的滲透率。我們第二季度的幾乎所有收入都來自前幾個季度開設的賬戶。雖然新帳戶增長放緩，但每個帳戶的數量卻在增加，而且我們看到大容量帳戶的穩步增長。我們計劃到今年年底將美國銷售隊伍擴大到 110 多個地區，每個地區將擁有大約 2 名臨床專家。

With the growing sales team, we are looking forward to the launch of C2+ in Q4, coupled with the tailwind of the improved inpatient reimbursement starting in October and the additional physician fee for coronary IVL starting in January. On the international side, we posted record revenue that was up 20% from last quarter and was over 70% higher than the year ago quarter. The headline of the quarter was Germany, where the increased reimbursement that took effect in January drove a doubling of coronary IVL revenue from a year ago. We expanded from 6 to 10 territories in Germany during Q2 of 2023 and expect to add more salespeople in the second half of the year to support increased demand.

隨著銷售團隊的不斷壯大，我們期待在第四季度推出 C2+，再加上從 10 月份開始改善住院報銷以及從 1 月份開始增加冠狀動脈 IVL 醫生費用。在國際方面，我們公佈了創紀錄的收入，比上季度增長 20%，比去年同期增長 70% 以上。本季度的頭條新聞是德國，該國 1 月份生效的報銷增加使冠狀動脈 IVL 收入比一年前翻了一番。 2023 年第二季度，我們將德國的地區從 6 個擴大到 10 個，預計下半年將增加更多銷售人員，以支持不斷增長的需求。

In Japan, the team posted great results in Q2. The revenue in Q2 more than doubled from Q1, and the momentum is increasing in the current Q3. We are encouraged by the physician response and are exceeding our expectations for penetration in the launched accounts. We expect that Japan will become a significant contributor to our global revenue in the coming years. We were pleased to see peripheral sales account for nearly 20% of our international sales in Q2. We've been adding headcount and focus to our peripheral efforts outside the U.S. and have expanded peripheral marketing programs and our KOL network in Europe. It is nice to see the hard work of the team pay off and bolster our non-U.S. peripheral business.

在日本，該團隊在第二季度取得了不錯的成績。 Q2的收入較Q1增長了一倍多，目前Q3的勢頭還在增強。我們對醫生的反應感到鼓舞，並且在已推出的賬戶中的滲透率超出了我們的預期。我們預計日本將在未來幾年成為我們全球收入的重要貢獻者。我們很高興看到第二季度外圍設備銷售額占我們國際銷售額的近 20%。我們一直在增加人員數量並重點關注美國以外的外圍工作，並擴大了歐洲的外圍營銷計劃和 KOL 網絡。很高興看到團隊的辛勤工作得到回報並支持我們的非美國周邊業務。

We also transitioned from distributor to direct sales in Canada, Spain and Portugal during the second quarter. Our distributors in those countries were good partners, but as we have typically seen, our direct teams can drive increased penetration due to their ability to focus exclusively on Shockwave products. While these changes caused some small disruptions in revenue and an increase in operating expense, we have seen that the investment quickly generates higher penetration in gross margin, more than offsetting the increased costs. We will transition to a direct sales model in Italy in Q4 of this year.

第二季度，我們還在加拿大、西班牙和葡萄牙從分銷商轉型為直銷。我們在這些國家的經銷商是很好的合作夥伴，但正如我們通常看到的那樣，我們的直接團隊可以提高滲透率，因為他們有能力專注於 Shockwave 產品。雖然這些變化對收入造成了一些小幅干擾並增加了運營費用，但我們看到投資很快就產生了更高的毛利率滲透率，足以抵消增加的成本。今年第四季度，我們將在意大利轉型為直銷模式。

On the Reducer side, we made good progress to rationalize the distribution network with the intent to focus resources on countries and centers that can both afford the product and build a solid practice treating underserved refractory angina patients. While the revenue contribution of Reducer will be relatively small this year, we are more optimistic than ever that we can build a sustained business. That said, we will do so methodically and are not in a hurry to generate revenue. We prefer at this point to continue building clinical evidence and partnering with centers of excellence in those countries to learn how to establish patient care pathways and achieve excellent outcomes for those patients.

在Reducer方面，我們在合理化分銷網絡方面取得了良好進展，旨在將資源集中在既能負擔得起產品又能為治療服務不足的難治性心絞痛患者建立可靠實踐的國家和中心。雖然今年Reducer的收入貢獻相對較小，但我們比以往任何時候都更加樂觀，我們可以建立一個可持續的業務。也就是說，我們將有條不紊地這樣做，並不急於創收。目前，我們更願意繼續建立臨床證據並與這些國家的卓越中心合作，以了解如何建立患者護理途徑並為這些患者取得優異的結果。

With that, I will turn the call to Dan to review the financials.

這樣，我就會打電話給丹來審查財務狀況。

Thank you, Isaac. Good afternoon, everyone. Shockwave Medical's revenue for the second quarter ended June 30, 2023, was $180.2 million, a 49% increase from $120.7 million in the second quarter of 2022. U.S. revenue was $144.9 million in the second quarter of 2023, an increase of 45% from $100.1 million in the second quarter of 2022.

謝謝你，艾薩克。大家下午好。 Shockwave Medical 截至2023 年6 月30 日的第二季度收入為1.802 億美元，比2022 年第二季度的1.207 億美元增長49%。 2023 年第二季度美國收入為1.449 億美元，比100.1 美元增長45 % 2022年第二季度將達到100萬美元。

The coronary products contributed $99 million to U.S. revenue in the second quarter of 2023, an increase of 37% from $72.1 million in the second quarter of 2022. The U.S. revenue from our peripheral products was $45.7 million in the second quarter of 2023, an increase of 65% from $27.7 million in the second quarter of 2022. The U.S. generated revenue was $0.2 million in the second quarter of 2023. The growth in U.S. revenue during the quarter reflects increased utilization of existing accounts, new account adoption of IVL and continued sales force expansion.

2023年第二季度，冠脈產品為美國貢獻了9900萬美元的收入，比2022年第二季度的7210萬美元增長了37%。2023年第二季度，我們的外圍產品在美國的收入為4570萬美元，增幅較2022 年第二季度的2770 萬美元增長65%。2023 年第二季度美國收入為20 萬美元。本季度美國收入的增長反映了現有賬戶利用率的提高、新賬戶採用IVL以及持續銷售力膨脹。

International revenue was $35.2 million in the second quarter of 2023, representing a 70% increase from $20.7 million in the second quarter of 2022. Coronary products contributed $26.7 million to international revenue in the second quarter of 2023, an increase of 70% from $15.7 million in the second quarter of 2022. International revenue from our peripheral products was $6.6 million in the second quarter of 2023, an increase of 57% from $4.2 million in the second quarter of 2022.

2023年第二季度國際收入為3520萬美元，比2022年第二季度的2070萬美元增長70%。冠脈產品為2023年第二季度國際收入貢獻2670萬美元，比1570萬美元增長70% 2022年第二季度。2023 年第二季度我們的外圍產品的國際收入為660 萬美元，比2022 年第二季度的420 萬美元增長57%。

The revenue from our Reducer product, which we acquired through the Neovasc acquisition that closed in April of this year, contributed $1.2 million to international revenue in the second quarter of 2023. Generators contributed $0.7 million to international revenue in the second quarter of 2023. The increase in the international revenue over the prior year period reflects continued geographic expansion, including China and Japan, the increased productivity of our direct selling teams in Europe and the strength of coronary sales in Germany.

我們通過今年 4 月完成的 Neovasc 收購獲得的減速器產品的收入為 2023 年第二季度的國際收入貢獻了 120 萬美元。發電機為 2023 年第二季度的國際收入貢獻了 70 萬美元。國際收入較上年同期增長反映了包括中國和日本在內的持續地域擴張、歐洲直銷團隊生產力的提高以及德國冠狀動脈銷售的實力。

Looking at product lines, our peripheral products, Shockwave M5, Shockwave M5+, Shockwave S4 and Shockwave L6 accounted for $52.3 million of total revenue in the second quarter of 2023 compared to $31.9 million in the second quarter of 2022, a 64% increase. Our coronary products, Shockwave C2, and Shockwave C2+ accounted for $125.8 million of total revenue in the second quarter of 2023, compared to $87.8 million in the second quarter of 2022, representing a 43% increase. Revenue from our Reducer product accounted for $1.2 million of total revenue in the second quarter of 2023. The sales of generators contributed $0.9 million in revenue in the second quarter of 2023.

從產品線來看，我們的外設產品Shockwave M5、Shockwave M5+、Shockwave S4和Shockwave L6在2023年第二季度的總收入中佔5230萬美元，而2022年第二季度為3190萬美元，增長了64%。我們的冠脈產品 Shockwave C2 和 Shockwave C2+ 在 2023 年第二季度的總收入中佔 1.258 億美元，而 2022 年第二季度為 8780 萬美元，增長了 43%。我們的減速機產品的收入佔 2023 年第二季度總收入的 120 萬美元。發電機的銷售在 2023 年第二季度貢獻了 90 萬美元的收入。

Gross profit for the second quarter of 2023 was $155.7 million compared to $104 million in the second quarter of 2022. Gross margin was 86.4% for the second quarter of 2023, which was slightly above the gross margin of 86.1% for the second quarter of 2022. Total operating expenses for the second quarter of 2023 were $123.3 million, a 66% increase from $74.4 million in the second quarter of 2022.

2023年第二季度的毛利潤為1.557億美元，而2022年第二季度的毛利潤為1.04億美元。2023年第二季度的毛利率為86.4%，略高於2022年第二季度86.1%的毛利率2023年第二季度的總運營費用為1.233億美元，比2022年第二季度的7440萬美元增長66%。

The sales and marketing expenses for the second quarter of 2023 were $56.7 million compared to $40.5 million in the second quarter of 2022. The increase was primarily driven by sales force expansion. R&D expenses for the second quarter of 2023 were $36.8 million compared to $20.8 million in the second quarter of 2022.

2023 年第二季度的銷售和營銷費用為 5670 萬美元，而 2022 年第二季度為 4050 萬美元。這一增長主要是由銷售隊伍擴張推動的。 2023 年第二季度的研發費用為 3680 萬美元，而 2022 年第二季度的研發費用為 2080 萬美元。

The increase was primarily driven by headcount growth, higher clinical-related expenses and facility expansion to sport R&D. General and administrative expenses for the second quarter of 2023 were $29.7 million compared to $13.2 million in the second quarter of 2022. The increase was primarily driven by higher headcount to support the growth of the business and legal and other acquisition-related expenses associated with the acquisition of Neovasc.

這一增長主要是由於人員數量增長、臨床相關費用增加以及體育研發設施擴建所致。 2023 年第二季度的一般和管理費用為2970 萬美元，而2022 年第二季度為1320 萬美元。這一增長主要是由於支持業務增長的員工人數增加以及與業務相關的法律和其他收購相關費用所致。收購 Neovasc。

We do not expect that the full year operating expense from Neovasc will exceed our prior full year forecast of approximately $32 million despite the higher-than-expected upfront nonrecurring spend in Q2 of 2023. We expect to continue to make significant investments to support and sustain our growth and anticipate full year 2023 operating margin in the range of 20% to 22%.

儘管 2023 年第二季度的前期非經常性支出高於預期，但我們預計 Neovasc 的全年運營費用不會超過我們之前約 3200 萬美元的全年預測。我們預計將繼續進行大量投資以支持和維持我們的增長並預計2023 年全年營業利潤率在20% 至22% 之間。

Excluding Neovasc, our operating margin range is expected to be 24% to 26%. Net income for the second quarter of 2023 was $28.9 million compared to net income of $25.6 million in the second quarter of 2022. Basic net income per share for the period was $0.79, diluted net income per share for the period was $0.76. We ended the second quarter of 2023 with $258.6 million in cash, cash equivalents and short-term investments.

不包括 Neovasc，我們的營業利潤率預計為 24% 至 26%。 2023 年第二季度淨利潤為 2890 萬美元，而 2022 年第二季度淨利潤為 2560 萬美元。該期間每股基本淨利潤為 0.79 美元，該期間稀釋每股淨利潤為 0.76 美元。截至 2023 年第二季度末，我們的現金、現金等價物和短期投資為 2.586 億美元。

At this point, I'd like to turn the call back to Doug for closing comments.

此時，我想將電話轉回道格以徵求結束意見。

Thank you, Dan, and thank you all for joining us today. We had a great quarter at Shockwave as we continue to execute and grow our existing businesses, while at the same time, paving an exciting path for our future.

謝謝丹，也謝謝大家今天加入我們。我們在 Shockwave 度過了一個美好的季度，我們繼續執行和發展現有業務，同時為我們的未來鋪平令人興奮的道路。

With that, I will open the call to questions.

接下來，我將開始提問。

(Operator Instructions) Our first question comes from Bill Plovanic with Canaccord Genuity.

（操作員說明）我們的第一個問題來自 Canaccord Genuity 的 Bill Plovanic。

Doug, I was wondering if you could help us understand just, you gave us some general time lines, but maybe some processing key dates as we look at the OPPS reimbursement and kind of how that kind of next things to look out for there? And then just any other color on the Investor Day at TCT, kind of major themes or topics you may cover?

道格，我想知道您是否可以幫助我們理解，您給了我們一些一般時間表，但也許在我們查看 OPPS 報銷時處理一些關鍵日期，以及接下來要注意的事情？然後，TCT 投資者日的任何其他顏色、您可能涉及的主要主題或主題是什麼？

Sure. And Thanks, Bill. And I'll tag team with Rob Fletcher, who is also on the call and who I think you guys are all familiar with now. So OPPS, there will be a final rule out this fall. We are not anticipating that IVL, will -- there will be any change or mention of IVL in the final rule. We think it's more likely that we'll see something in the proposed rule next summer, so that we'd go from tangential pass-through sunsetting at the end of June. And then early in July, we'd see a how we would map to what we believe will be APC 51.94 starting January of 2025. And Rob, I don't know if you want to add color on that.

當然。謝謝，比爾。我將與 Rob Fletcher 合作，他也在電話會議中，我想你們現在都熟悉他了。所以，OPPS，今年秋天將會有最終的排除。我們預計 IVL 不會在最終規則中發生任何變化或提及 IVL。我們認為明年夏天我們更有可能在提議的規則中看到一些東西，這樣我們就可以在六月底從切向通過日落開始。然後在 7 月初，我們將看到如何映射到我們認為從 2025 年 1 月開始的 APC 51.94。Rob，我不知道你是否想對此添加顏色。

Well said, Doug, the next thing from CMS, Bill, that we'll see as Doug stated, it was on November 1 when the final OPPS for calendar year 2024 is issued -- on approximately November 1.

說得好，道格，CMS 的下一件事，比爾，正如道格所說，我們將在 11 月 1 日看到 2024 日曆年的最終 OPPS 發布——大約在 11 月 1 日。

And then for Investor Day, we'll see, obviously, the spectrum of our pipeline, peripheral, coronary, structural heart and the Reducer should see several new products that we've not talked about previously. And looking forward to folks participation. We're excited about our pipeline. Our customers are incredibly excited about our pipeline. And hopefully, our investors are too once they get a glimpse of it.

然後在投資者日，我們顯然會看到我們的管道、外周、冠狀動脈、結構心臟和減速器的範圍應該會看到一些我們之前沒有討論過的新產品。並期待大家的參與。我們對我們的管道感到興奮。我們的客戶對我們的管道感到非常興奮。希望我們的投資者在看到它後也會如此。

It will truncate it to things that we think are appropriate to share at this time. We have some very interesting things under the cover, but put no need to preview things for our competition that we wouldn't be launching until sort of after 2026. So we're still going to keep it to a reasonably near-term pipeline other than things that have already been disclosed previously, such as our structural heart platform.

它將把它截斷為我們認為此時適合分享的內容。我們有一些非常有趣的東西，但沒有必要為我們的競爭對手預覽一些我們要到 2026 年之後才會推出的東西。所以我們仍然會將其保留在合理的近期管道中比之前已經披露的東西，例如我們的結構心臟平台。

Great. And then on guidance, just what are you contemplating in the high end in the low end of that range that you're giving? And then -- just I don't know how -- if Dan, why don't you say how many onetime costs kind of we saw in that quarter that won't be reproduced kind of in Q2 and Q3 and operating? And we'll see it this week at our conference.

偉大的。然後根據指導，您在給出的範圍的高端和低端中考慮了什麼？然後 - 只是我不知道如何 - 如果丹，你為什麼不說我們在該季度看到的一次性成本有多少不會在第二季度和第三季度和運營中重現？我們將在本週的會議上看到它。

So Dan -- we can go back and forth. As we look to the back end of this year, obviously, you've got as we have expanded our footprint and our -- over 1,500 cath labs in the U.S. and obviously, lots of cath labs internationally will -- we feel seasonality in the summer in the Northern Hemisphere as other companies do. And as Isaac elucidated, we are continuing to add accounts, but at -- not at the same clip as we did a couple of years ago, obviously. So we'll -- we see the year progressing with substantial growth in the back half, but weighted more in the fourth quarter.

所以丹——我們可以來回討論。展望今年年底，顯然，隨著我們擴大業務範圍，以及我們的——美國超過 1,500 個導管實驗室，顯然，國際上的許多導管實驗室也會——我們感受到了季節性和其他公司一樣，在北半球夏季。正如艾薩克所闡明的，我們正在繼續添加帳戶，但顯然與幾年前的速度不同。因此，我們預計今年下半年將出現大幅增長，但第四季度的權重會更大。

And Dan, I don't know if you want to add into that?

丹，我不知道你是否想補充一下？

Sure. It was about $6 million nonrecurring for Neovasc and that was mainly changing control, severance.

當然。 Neovasc 的非經常性費用約為 600 萬美元，主要用於控制權變更和遣散費。

Our next question is from Travis Steed with Bank of America.

我們的下一個問題來自美國銀行的 Travis Steed。

Just wanted to follow up on the margin question. The $6 million nonrecurring, was that in G&A because I was going to ask about the $10 million step-up in G&A. And then the op margin guidance for the year, just want to be clear, it looks like it was at 22% to 23% at the beginning of the year, and now you're guiding to 20% to 22%. You've got Neovasc in there. I just want to see what else changed in the full year op margin guide versus 3 months ago? And how to think about margin expansion kind of beyond that in '24, if we should be closer to a couple of hundred basis points of margin expansion or not, if you can continue to expand margins?

只是想跟進保證金問題。 600 萬美元的非經常性費用是 G&A 中的費用，因為我要詢問 G&A 中 1000 萬美元的增量。然後是今年的運營利潤率指導，我想澄清一下，年初的運營利潤率指導為 22% 至 23%，現在指導為 20% 至 22%。裡面有 Neovasc。我只是想看看全年運營利潤率指南與 3 個月前相比還有哪些變化？如何考慮超出 24 年的利潤率擴張，我們是否應該接近幾百個基點的利潤率擴張，是否可以繼續擴大利潤率？

Sure. So most of that $6 million nonrecurring was in G&A. We're still expecting about $32 million in OpEx for Reducer, as I noted earlier, it was most -- we had a bigger chunk than expected in Q2. So if you looked at the combined margin, it's at 18%. If we look just at the base business, the operating margin is 25.6%. So a slight improvement over Q1 even with our kind of pickup in investment that Doug alluded to.

當然。因此，這 600 萬美元的非經常性支出大部分用於一般管理費用。正如我之前指出的，我們仍然預計Reducer 的運營支出約為 3200 萬美元，這是最多的——我們在第二季度的支出比預期的要大。所以如果你看一下綜合利潤率，它是 18%。如果我們只看基礎業務，營業利潤率為 25.6%。因此，儘管道格提到的投資有所回升，但比第一季度略有改善。

As far as this year, we did give -- in the past, we had given like 26%, 27% without Neovasc. So we've knocked that down to 24% to 26%. We're feeling very good about some R&D programs. So the decrease is really kind of driven by probably a little more spend in R&D programs, a little more spend in clinical, we're accelerating some Costa Rica activities to get that plant up and running, which will help our margin down the road and that's hitting R&D right now, and then we also increased the footprint.

就今年而言，我們確實給予了——過去，我們在沒有 Neovasc 的情況下給予了 26%、27%。所以我們把這個比例降低到了 24% 到 26%。我們對一些研發項目感覺非常好。因此，這種減少實際上是由於研發項目的支出增加了一點，臨床支出增加了一點，我們正在加快哥斯達黎加的一些活動，以使該工廠啟動並運行，這將有助於我們的利潤率和現在正在影響研發，然後我們也增加了足跡。

So we've always said we're going to spend what we need to spend to grow the business in near and long term. So that's where you get a little bit of 100, 200 basis points of potential hit to the margin from what we said 3 months ago. But I think it's smart money.

因此，我們總是說我們將花費我們需要的資金來發展近期和長期的業務。因此，與我們 3 個月前所說的相比，利潤率可能會受到 100、200 個基點的潛在影響。但我認為這是明智的投資。

Longer term, we expect -- like I said, this is a big investment year. '25, '26, we'll be back up. We'll absorb and get some scale and be back to where we've kind of always guided, which was the upper 20s.

從長遠來看，我們預計——就像我說的那樣，這是一個大投資的一年。 25、26，我們會回來的。我們將吸收並獲得一定的規模，然後回到我們一直引導的位置，即 20 歲以上。

Okay. Great. And Doug, on the 6-month GAAP scenario, just curious if your customers are talking about that yet or it's too early and your willingness to kind of help customers through that and how you think about the impact on kind of the overall revenue, if any at all?

好的。偉大的。道格，關於6 個月的GAAP 情景，只是好奇您的客戶是否正在談論這個問題，或者現在還為時過早，您是否願意幫助客戶解決這個問題，以及您如何看待這對整體收入的影響，如果有嗎？

Yes. No, customers are just now becoming aware of the inpatient reimbursement well, barely aware of the reimbursement because it's not even coming into fruition here for a few months. So that's -- that will be the next order of business is making sure they're aware of that, then comes physician, the physician fees, which will be finalized in the fall and then go into effect in January. The outpatient transition from NTAP to permanent is so far in the future that no, that's not really getting any airtime.

是的。不，客戶現在才開始意識到住院報銷，幾乎不知道報銷，因為它甚至幾個月後才在這裡實現。所以，下一個任務是確保他們意識到這一點，然後是醫生、醫生費用，這將在秋季敲定，然後在一月份生效。從 NTAP 到永久的門診過渡是遙遠的未來，不，這並沒有真正得到任何播出時間。

And at this juncture, we're -- as we've said before, we think the assuming the transition is from that July until January, we're not really anticipating and impact on our business. You've got the other 2 very favorable outcomes on the reimbursement side between physicians and outpatient -- physician fee and outpatient, inpatient. And there's so much momentum, clinical momentum behind in our device, so we're not anticipating a change in utilization rates.

在這個節骨眼上，正如我們之前所說，我們認為假設過渡是從七月到一月，我們並沒有真正預期對我們業務的影響。在醫生和門診病人之間的報銷方面，你還得到了另外兩個非常有利的結果——醫生費用和門診病人、住院病人。我們的設備背後有如此多的動力、臨床動力，所以我們預計利用率不會發生變化。

Next question is from Adam Maeder with Piper Sandler.

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

I wanted to start with one on the top line guidance. Healthy guidance raised here, I think, $17.5 million at the midpoint beat Q2 by $6 million and change. So maybe just talk about kind of what's giving the confidence to raise by the larger amounts, are you able to kind of bridge us with specific components in that guidance increase? And what's being contemplated for Reducer in that updated number? And I have a follow-up.

我想從最重要的指導開始。我認為，這裡提出了健康的指導，中間點為 1750 萬美元，比第二季度高出 600 萬美元，並且發生了變化。因此，也許只是談談是什麼給了我們增加更多資金的信心，您是否能夠為我們提供引導增加中的具體組成部分？更新後的數字中對Reducer 有何考慮？我有一個後續行動。

Yes. I'll -- maybe I'll let Isaac just chime in a little bit on sort of what he's seeing in the market that gives us confidence. So on Reducer, we're -- as we said on our last call, in aggregate, it's going to be less than $5 million for the year. We did $1.2 million last quarter. We're very focused on understanding the model, how do you impact referrals for these patients, and we're focusing on a small handful of countries as we transition from the former Neovasc team, many of whom will stay with us on the commercial side and others we'll be adding to in some countries.

是的。我會——也許我會讓艾薩克插話一下他在市場上看到的一些給我們信心的事情。因此，在Reducer 上，正如我們在上次電話會議上所說，今年的總成本將低於 500 萬美元。上個季度我們賺了 120 萬美元。我們非常專注於了解該模型，如何影響這些患者的轉診，並且在我們從前 Neovasc 團隊過渡時，我們將重點放在少數國家，其中許多人將在商業方面留在我們身邊我們將在某些國家/地區添加其他內容。

But the focus is not on taking that $1.2 million and making it $2 million, the focus is how do we take that commercial experience so that we are poised once we have COSIRA-II data which we think will be helpful -- well, necessary for U.S. approval, but incredibly helpful for driving global adoption. We want to really understand the model well, which is what we're working on now. And then, Isaac, maybe a bit of what you're seeing in the field.

但重點不是把那120 萬美元變成200 萬美元，重點是我們如何利用這種商業經驗，以便一旦我們擁有COSIRA-II 數據，我們就可以做好準備，我們認為這些數據會有所幫助——好吧，對於美國的批准，但對推動全球採用非常有幫助。我們想要真正很好地理解這個模型，這就是我們現在正在做的事情。然後，艾薩克，也許是你在現場看到的一些情況。

Yes, sure. I think if you look at what we see for revenue in the second half and the increased guidance, we're -- Q3 will be seasonal as it is for everybody. We'll still be able to grow through that, but probably modest growth quarter-on-quarter in Q3 versus Q2. And particularly with the international business really being much more seasonal in Q3. And then as we go into Q4, we'll have Japan, we expect, obviously, quarter-on-quarter growth throughout the year, but you're getting a bigger contribution from Japan in Q4, and we're pleased with what we saw in Japan in Q2 compared to what our expectations were.

是的，當然。我認為，如果你看看我們下半年的收入情況以及增加的指導，我們會發現第三季度將是季節性的，因為它對每個人來說都是季節性的。我們仍然能夠實現增長，但第三季度與第二季度相比可能會出現溫和的季度增長。特別是第三季度的國際業務確實更具季節性。然後，當我們進入第四季度時，我們將看到日本，顯然，我們預計全年將實現季度環比增長，但日本在第四季度將做出更大的貢獻，我們對我們的表現感到滿意與我們的預期相比，第二季度日本的情況。

We'll have the U.S. coronary business, in particular, with a new product launch of C2+ in the fourth quarter, and that will be coupled with the story for our customers on the inpatient reimbursement that's taken effect in October.

我們將特別關注美國的冠狀動脈業務，並在第四季度推出 C2+ 新產品，同時還將向我們的客戶介紹 10 月份生效的住院報銷的故事。

And then generally, with the international businesses, we've seen some really strong performance this year. We'll have a nice tailwind in Germany that's going to continue to build. We'll have direct selling organizations now in Spain and Canada, which will be nice contributors incrementally as they go, and then we'll have Italy going direct in Q4. So we think there's a nice momentum going into the second half, and that kind of builds on itself as we come out of the seasonal Q3 with the growth drivers mentioned in Q4.

總的來說，對於國際業務，我們今年看到了一些非常強勁的表現。我們將在德國獲得良好的順風，並將繼續增強。我們現在將在西班牙和加拿大設立直銷組織，隨著它們的發展，它們將逐漸成為很好的貢獻者，然後我們將在第四季度讓意大利直銷。因此，我們認為下半年將出現良好的勢頭，並且當我們帶著第四季度提到的增長動力走出第三季度時，這種勢頭就會自行建立。

That's a great color.

這是一個很棒的顏色。

And we also think -- we also -- we have 2 additional stimuli in the U.S. in the fourth quarter with C2+ launch and then inpatient reimbursement. So we're -- and I think we're -- we continue to see building momentum and benefit from the physician education investments we've done this year, which is quite substantial relative to prior years. And the work we've done to continue building out our sales and clinical specialist teams. So that continues to bear fruit, it bore fruit last quarter, it will bear fruit through the end of this year.

我們還認為，第四季度我們在美國還有兩項額外的刺激措施，即 C2+ 的推出以及住院報銷。因此，我們——我認為我們——我們繼續看到我們今年所做的醫生教育投資的勢頭和受益，這與前幾年相比是相當可觀的。我們為繼續建設我們的銷售和臨床專家團隊所做的工作。這樣就繼續取得成果，上個季度取得成果，並將在今年年底取得成果。

Very helpful color. I guess just one quick clarification. So in the previous guidance range, were you assuming roughly $5 million for Reducer? I guess I want to understand that? Or is that added into the updated guidance this go around? And then I have a follow-up.

非常有用的顏色。我想只需快速澄清一下即可。那麼在之前的指導範圍內，您是否假設Reducer 的成本約為 500 萬美元？我想我想明白這一點？或者這是否已添加到本次更新的指南中？然後我有一個後續行動。

Yes, we -- so at beginning of the year, obviously, no Reducer because we didn't have it. But as we look in our last commentary, Reducer was incorporated into our expectations. Not everybody's model on the street incorporated Neovasc into either the spend or the revenue. So there's a little bit of a mixed bag on the street, but we did include it.

是的，我們——所以在今年年初，顯然沒有Reducer，因為我們沒有它。但正如我們在上一篇評論中看到的那樣，Reducer 已納入我們的期望之中。並不是街上每個人的模型都將 Neovasc 納入支出或收入中。所以街上有一些魚龍混雜的東西，但我們確實把它包括在內。

Okay. Perfect. And then for the follow-up, Doug, both you and Isaac touched on it in your last response, but C2+ just was hoping to get a little bit more color in terms of the U.S. launch in terms of pricing strategy, how quickly will that roll out? And I guess, how much of a potential growth lever is for that business?

好的。完美的。接下來，Doug，您和 Isaac 在上次回復中都談到了這一點，但 C2+ 只是希望在定價策略方面獲得更多有關美國發布的信息，具體要多快才能實現推出？我猜想，該業務的潛在增長槓桿有多大？

Yes. Go ahead, Isaac.

是的。繼續吧，艾薩克。

Sure. Yes, good question. So in the U.S., we'll bring C2+ with price parity on C2 so same price point. The launch strategy is really coupling the message of the improvements that you can get with C2+ compared to C2. And then really -- we feel very good about those based on what we've seen with the launch in the international markets, a couple of that message with an in-service and the reimbursement message for inpatient, the inpatient change on October 1. So we'll launch kind of a typical -- we've got more territories than we have in the past. So I expect this launch will go more quickly than prior launches, the product C2+ compared to C2, it's reasonably simple to explain. You could basically get 50% more power, more pulses.

當然。是的，好問題。因此，在美國，我們將推出 C2+，其價格與 C2 相同，因此價格點相同。發布策略實際上結合了與 C2 相比，C2+ 可以獲得的改進信息。然後真的 - 我們對這些基於我們在國際市場上的推出所看到的信息感到非常好，其中有一些關於在職信息和住院患者報銷信息，以及 10 月 1 日住院患者的變化。因此，我們將推出一種典型的方式——我們擁有比過去更多的地區。因此，我預計這次發布將比之前的發布更快，產品 C2+ 與 C2 相比，解釋起來相當簡單。您基本上可以獲得 50% 以上的功率、更多的脈衝。

And oh, by the way, you're now getting this incremental reimbursement that did not exist before on the inpatient side of your business, and we'll kind of do a -- we're still contemplating the specific tactics, but I expect the launch to go reasonably quickly and kind of roll it up in the next probably 2 quarters, so kind of be through most of the launch by the end of Q1 of '24. And part of the reason for that is we need to -- as we launch 2 products a year, we need the teams kind of clearing the launch in roughly 6 months, they can get ready for the next launch.

哦，順便說一句，您現在獲得了以前在您的業務住院方面不存在的增量報銷，我們會做 - 我們仍在考慮具體策略，但我預計發布將相當快地進行，並在接下來的兩個季度內完成，因此在24 年第一季度末之前將完成大部分發布。部分原因是我們需要——當我們每年推出 2 個產品時，我們需要團隊在大約 6 個月內完成發布，他們可以為下一次發布做好準備。

Our next question is from Michael Polark with Wolfe Research.

我們的下一個問題來自 Wolfe Research 的 Michael Polark。

I will continue the thread on C2+ maybe as to ask a very specific question. From the Europe launch thus far, the analogy there. Kind of what have you seen in same-store sales impact from C2+ kind of how much more productive does it make these accounts? Would you hazard a number of framework?

我將繼續 C2+ 主題，也許會問一個非常具體的問題。從歐洲推出至今，類比就在那裡。您在 C2+ 的同店銷售影響中看到了什麼？它使這些帳戶的生產力提高了多少？你會冒險使用一些框架嗎？

That's a good question. I don't have a good number for you, Matt, right at this moment. I think we do think there's an incremental uptick. It's a little hard to divorce that from just the base momentum. If we -- if we didn't put C2+ and we were still growing same-store sales at a pretty good clip, at least to the extent we can see the same-store sales in our direct selling markets.

這是個好問題。馬特，我現在沒有合適的電話號碼給你。我認為我們確實認為存在增量上升。很難將其與基本動力分開。如果我們——如果我們沒有採用 C2+，並且我們的同店銷售額仍然以相當不錯的速度增長，至少在我們的直銷市場中可以看到同店銷售額。

But we do think there's from an anecdotal perspective, if you -- when do you pull IVL versus something else or take your shot without using IVL and I think C2+ with the additional pulses addresses some of those anecdotal question marks that customers have about when to use IVL and that's longer, more diffuse lesions where they don't want to -- they don't want be able to treat the whole lesion with 1 catheter. We think C2+ is a benefit for that. And that's what our customers are telling us as we've launched internationally.

但我們確實認為，從軼事的角度來看，如果你——什麼時候拉IVL 與其他東西相比，或者在不使用IVL 的情況下進行射擊，我認為帶有額外脈衝的C2+ 解決了客戶關於何時使用IVL 的一些軼事問號。使用 IVL 會導致更長、更彌散的病變，而他們不想這樣做——他們不希望能夠用 1 個導管治療整個病變。我們認為 C2+ 對此有好處。當我們在國際上推出產品時，這就是我們的客戶告訴我們的。

And then also for nodular and eccentric calcium, and we've done a lot of good work on the publication, clinical trial and publication standpoint on that this year, educating on how IVL works in those really difficult nodular or eccentric coronary lesions. And we think the additional pulses help that story and help the results in those lesions even more. So I think kind of -- both of those aspects are where our customers are telling us they're getting better results and they feel more comfortable pulling IVL with the 120 pulse catheter than the [80] pulse catheter.

然後還有結節性和偏心性鈣，今年我們在出版物、臨床試驗和出版立場方面做了很多出色的工作，教育IVL 如何在那些真正困難的結節性或偏心性冠狀動脈病變中發揮作用。我們認為額外的脈衝有助於這個故事，並且對這些病變的結果更有幫助。所以我認為，在這兩個方面，我們的客戶都告訴我們，他們獲得了更好的結果，並且他們感覺使用 120 脈衝導管拉動 IVL 比使用 [80] 脈衝導管更舒服。

So the follow-up question on Reducer, and maybe my note on this was sufficiently squishy such that, that's the answer. But I had a wide range for potential U.S. approval, 2025, 2026, 2027. I heard on the prepared remarks Doug, 2027 now is the target. So kind of -- to the extent that was a range in your mind as well before, why the back end of the range, what have you learned that kind of wants you to position a little more runway there before it could come to market?

所以關於Reducer 的後續問題，也許我對此的註釋足夠軟弱，這就是答案。但我對美國批准的可能性有很寬的範圍，2025 年、2026 年、2027 年。我聽到 Doug 準備好的講話，現在的目標是 2027 年。那麼，就某種程度上來說，這也是您以前腦海中的一個範圍，為什麼要在該範圍的後端，您學到了什麼，希望您在它進入市場之前在那裡放置更多的跑道？

Yes. Neovasc had been publicly saying 2025, and when we inherited it, we inherited a trial that had really slowed down to a crawl at best, which we are now switching from crawl to walk and then probably run next year. And so we weren't sure when we bought it, how quickly we'd be able to stimulate enrollment. So we were cautious about sort of being leaning in too heavily on when we -- how long we expected the trial to take to enroll. And now that we understand it, it's a fascinating sophisticated complex trial in terms of enrollment. And so we think we're going to have a significant impact, but there's sort of only so much we can do from where we stand today. And so we thought it better to make sure everybody understands that it's going to take a bit of time to enroll.

是的。 Neovasc 一直公開宣稱要到 2025 年，當我們繼承它時，我們繼承了一項試驗，該試驗最多只能慢到爬行，我們現在從爬行切換到步行，然後可能在明年運行。因此，我們不確定何時購買它，也不確定能夠以多快的速度刺激入學。因此，我們對過於依賴我們預計試驗需要多長時間才能入組持謹慎態度。現在我們明白了，就註冊而言，這是一項令人著迷的複雜試驗。因此，我們認為我們將產生重大影響，但從目前的情況來看，我們能做的就只有這麼多。因此，我們認為最好確保每個人都明白註冊需要一些時間。

And we didn't want to have models still sort of landing in 2025 approval because, we don't think that's at all likely and hard to even imagine how we could get enrollment done fast enough to get a 2025 approval. There are -- on the back end, there are things that might offer some upside on approval time lines, like do you or do you not have a panel, but we think it's safest to just assume a 2027 approval at this juncture.

我們不希望模型在 2025 年獲得批准，因為我們認為這根本不可能，甚至很難想像我們如何能夠足夠快地完成註冊以獲得 2025 年批准。在後端，有些事情可能會在批准時間表上帶來一些好處，比如你是否有一個小組，但我們認為此時假設 2027 年獲得批准是最安全的。

Our next question comes from Larry Biegelsen with Wells Fargo.

我們的下一個問題來自富國銀行的拉里·比格爾森。

A couple of quick ones for me, Doug. The Investor Day, TCT, is there a plan to give any kind of long-term financial guidance or any kind of -- anything directional?

道格，給我幾個快速的。投資者日，TCT，是否有計劃提供任何長期財務指導或任何方向性的指導？

We will let you know when we get there, Larry. We're calling it an Innovation Day. We want to focus on technology, but we appreciate that at a lot of these Investor Days that folks are looking for a bit of a view into the future. So we'll be thoughtful about what we share for sort of future financial outlook.

拉里，我們到達那里後會通知你。我們稱之為創新日。我們希望專注於技術，但我們很高興在投資者日的很多日子裡，人們都在尋求對未來的一些看法。因此，我們將認真考慮我們所分享的未來財務前景。

That's helpful. And I was also surprised by the Reducer 2027 date. So I wanted to just understand what that assumes, Doug. So Gregg Stone said they had 42 patients enrolled last year at TCT. They hope to complete by the end of '23 enrollment. It's an adaptive design. So what are you assuming? Is the first interim analysis at 380 and you can roll up to 760. Just help us understand kind of what you're assuming to get to that 2027 U.S. approval?

這很有幫助。我對Reducer 2027 的日期也感到驚訝。所以我想了解一下假設是什麼，道格。 Gregg Stone 表示，去年 TCT 招收了 42 名患者。他們希望在 23 年底前完成註冊。這是一種自適應設計。那麼你假設什麼呢？第一個中期分析是 380，您可以增加到 760。請幫助我們了解您認為 2027 年美國批准的情況是什麼？

Yes. So you've got to get one of the ways that the trial had been characterized in the past was focusing on enrollment. What really matters is randomization. So they didn't have 40-some-odd randomized, and that's what we need 380 randomized. And so where we stand today with sort of less than half of the sites, well, frankly, fewer than 20 had been initiated -- had been activated when we bought the company out of that 50 that we'll eventually get to.

是的。因此，你必須了解過去試驗的特點之一就是關注入組。真正重要的是隨機化。所以他們沒有 40 多個隨機樣本，而我們需要 380 個隨機樣本。因此，我們今天的情況是，只有不到一半的網站，嗯，坦率地說，只有不到20 個網站已經啟動——當我們最終收購的50 個網站中，只有不到20 個網站是在我們收購該公司時激活的。

So we're now adding sites -- activating sites at a better clip. And yet enrollment, you got to get the site activated for the randomizations to happen, et cetera. So we're anticipating that the final randomized patient will be sometime in 2025, probably back half of 2025 based on what we're seeing in the trajectory so far, which then you got to follow the patients, submit, et cetera, which is how we kind of realistically landed in 2027.

所以我們現在正在添加站點——以更好的剪輯激活站點。然而，註冊時，你必須激活網站才能進行隨機化，等等。因此，我們預計最終的隨機患者將在 2025 年的某個時候，根據我們迄今為止所看到的軌跡，可能是 2025 年下半年，然後你必須跟踪患者、提交等等，這就是我們如何真正實現2027 年的目標。

I'll just add on to that, Larry. It's -- where we've landed is not frankly, is about right where we thought we would land as we looked at this and then peeled it back after the acquisition. We sort of have a what we thought were overly rosy and optimistic expectations from previous management on that trial enrollment. We were hopeful that they were right. But as we've integrated and spent the last 3, 4 months, get our arms around it and putting new plans in place, it's landing about where we thought it would. So that's sort of the bid ask, I think, is what did previous management think and was that realistic compared to what we think now.

我會補充一點，拉里。坦率地說，我們所到達的地方並不是我們認為我們會到達的地方，因為我們看到了這一點，然後在收購後將其剝離。我們認為以前的管理層對試驗註冊的期望過於樂觀和樂觀。我們希望他們是對的。但隨著我們在過去的三、四個月裡進行整合、全力以赴並製定新的計劃，它已經達到了我們預期的水平。我認為，這就是以前的管理層的想法，並且與我們現在的想法相比，這是現實的。

Our next question is from Imron Zafar with Deutsche Bank.

我們的下一個問題來自德意志銀行的伊姆龍·紮法爾。

I wanted to focus on the international business first. It sounds like the launch is in all the big 3 OUS markets, China, Japan and Germany are all going -- played well. I was just wondering if you can talk about the relative growth contribution from those 3 geographies in the back half and especially in 2024?

我想首先專注於國際業務。聽起來，美國三大市場（中國、日本和德國）的發布都進展順利——進展順利。我只是想知道您是否可以談談這 3 個地區在下半年、特別是 2024 年的相對增長貢獻？

Yeah, go ahead. Go ahead.

是的，繼續吧。前進。

Yes. I mean we probably would not gonna say, we anticipate they're all going to continue to be healthy growth. If from a dollar growth perspective, I haven't really scrubbed down 2024 yet, but if -- just based on what -- and we're 2 quarters in Japan. So that's pretty early. And we are 2 quarters into the improved reimbursement situation in Germany, which is already having a substantial effect on revenue growth compared to the last 4 years that we've had in Germany.

是的。我的意思是我們可能不會說，我們預計它們都將繼續健康增長。如果從美元增長的角度來看，我還沒有真正取消 2024 年的目標，但如果——僅基於什麼——我們在日本已經有兩個季度了。所以這還很早。德國的報銷狀況已經改善了兩個季度，與德國過去四年相比，這已經對收入增長產生了重大影響。

So I would expect that as we go through this year and into next year, you're going to see kind of largest dollar growth coming out of Japan, and then Germany and China. It's a little early to tell yet for Germany, but Germany is looking strong right now.

因此，我預計，今年和明年，您將看到最大的美元增長來自日本，然後是德國和中國。對於德國來說現在下結論還為時過早，但德國目前看起來很強大。

Okay. And then on this top of the relative growth rates, it looks like Street is looking for pretty similar growth in 2024 for coronary and peripheral, sort of the mid-20s. Is that consistent with your thinking for next year?

好的。然後，在相對增長率的基礎上，Street 似乎正在尋找 2024 年冠狀動脈和外周血管的增長非常相似，大約在 20 多歲左右。這與你明年的想法一致嗎？

We've not -- we certainly expect next year to be a very strong growth year, but we've not characterized what we think top line is going to be. So I think I'll shy away from that until we until we have a chance to put a number out there.

我們當然預計明年將是一個非常強勁的增長年，但我們還沒有描述我們認為的頂線將會是什麼。所以我想我會迴避這個問題，直到我們有機會公佈一個數字。

Our next question is from Mike Matson with Needham & Company.

我們的下一個問題來自 Needham & Company 的 Mike Matson。

Just a couple on the peripheral business. So just wondering if you could maybe compare kind of what you're seeing in terms of adoption trends, customer objections, et cetera, in peripheral versus what you've seen in coronary? And then just the international peripheral business you commented, I know it's small, but maybe just talk about what -- where you're seeing some traction there, I guess, what countries?

只是一些外圍業務的夫婦。所以想知道您是否可以將您在外周血管中所看到的採用趨勢、客戶反對意見等方面所看到的情況與您在冠狀動脈中所看到的情況進行比較？然後就是你評論的國際外圍業務，我知道它很小，但也許只是談論什麼 - 你在那裡看到了一些吸引力，我猜是哪些國家？

Yes. So Isaac, I'll tag team this one, too. The peripheral market and the coronary market, obviously dramatically different. The sort of sales model in peripheral across the industry, not just Shockwave is a little bit more labor intensive and we think one of the real benefits that we're seeing from the expansion of our clinical specialist team is that we have better wear with all to both support our coronary business, but more importantly, support the sort of the case coverage that is expected and from which sales benefit on in the peripheral lab.

是的。所以艾薩克，我也會給這個團隊貼上標籤。外圍市場和冠狀市場，顯然有很大不同。整個行業的外圍銷售模式（不僅僅是 Shockwave）有點勞動密集型，我們認為，我們從臨床專家團隊的擴張中看到的真正好處之一是，我們可以更好地穿戴所有產品。既支持我們的冠狀動脈業務，但更重要的是，支持預期的病例覆蓋範圍，並從中受益於外圍實驗室的銷售。

There is certainly -- I think we do benefit from the peripheral coronary synergy in our bag because we have one team in a territory that can sell to the cardiologists, who does both practices peripheral and coronary interventions and a very high percentage of our customers do both, which is why -- one of the reasons of very high percentage of our hospitals use both coronary and peripheral. But we also will have a larger portfolio, as we already do on peripheral with L6 and M5+, S4 and a couple of our next product launches are also going to be in peripheral. So we'll have a more complex and more sophisticated bag because you're covering a much broader spectrum of vessels versus on coronary, we have C2 and then we'll have C2+.

當然，我認為我們確實受益於我們包裡的外周冠狀動脈協同作用，因為我們在一個地區有一個團隊可以向心髒病專家出售產品，他們同時進行外周和冠狀動脈介入治療，而且我們的客戶中很大一部分都進行外周和冠狀動脈介入治療。兩者兼而有之，這就是為什麼——我們醫院中有很高比例同時使用冠狀動脈和外周血管的原因之一。但我們也將擁有更大的產品組合，就像我們已經在外設領域所做的那樣，包括 L6 和 M5+、S4，並且我們接下來發布的一些產品也將在外設領域。因此，我們將有一個更複雜、更先進的袋子，因為與冠狀動脈相比，您覆蓋的血管範圍更廣，我們有 C2，然後我們將有 C2+。

In the future, we'll have 2 or 3 coronary products that we'll be selling simultaneously. But for now, it's a little bit more sort of targeted with the C2 version depending on where you're selling. And Isaac, I don't know if you want to jump in on the international aspect.

將來，我們將同時銷售 2 或 3 種冠狀動脈產品。但目前，C2 版本的針對性更強，具體取決於您的銷售地點。艾薩克，我不知道你是否想參與國際方面的工作。

Sure. Yes. The international peripheral, as you mentioned, it's a small number, but it's -- we've started as we've gone and had more focus in some of the large European countries with the direct sales force. That sales force and some marketing or horsepower that we put behind it has really done a nice job of really introducing the peripheral product to many customers because the distributors -- with a lot of work and relatively a lot of effort for a relatively small juice for the distributors to focus on peripheral internationally.

當然。是的。正如您提到的，國際外圍國家的數量很少，但我們已經開始，並且更加關註一些擁有直銷隊伍的歐洲大國。我們在其背後投入的銷售隊伍和一些營銷或馬力確實做得很好，確實向許多客戶介紹了外圍產品，因為分銷商付出了大量的工作和相對大量的努力，以獲得相對較小的果汁分銷商專注於國際外圍設備。

But as our team has gotten on it, we've gets just a nice incremental growth driver, and we're seeing good patterns of vascular surgery, primarily vascular surgery adoption in the European countries.

但隨著我們團隊的不斷努力，我們獲得了良好的增量增長動力，並且我們看到了血管手術的良好模式，主要是歐洲國家血管手術的採用。

We've reached the end of the question-and-answer session. I'd now like to turn the call back over to Doug Godshall for closing comments.

我們的問答環節已經結束了。我現在想將電話轉回 Doug Godshall 以徵求結束意見。

Thanks, everybody, for your time and attention and continued interest in Shockwave. We're obviously incredibly enthusiastic about the next 6 months and multiple years ahead of us. Thanks for your time, everybody.

感謝大家的時間和關注以及對 Shockwave 的持續關注。顯然，我們對未來 6 個月和未來幾年充滿了極大的熱情。謝謝大家抽出時間。

This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.

今天的會議到此結束。此時您可以斷開線路，我們感謝您的參與。