Shockwave Medical Inc (SWAV) 2023 Q4 法說會逐字稿

Good afternoon, and welcome to Shockwave's Fourth Quarter and Full Year 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 Debbie Kaster, Vice President of Investor Relations at Shockwave for a few introductory comments.

下午好，歡迎參加 Shockwave 2023 年第四季和全年財報電話會議。 （操作員說明）謹此提醒，此通話正在錄音以供重播之用。我現在想將電話轉給 Shockwave 投資者關係副總裁 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 Renee Gaeta, Chief Financial Officer. Earlier today, Shockwave released financial results for the quarter and year ended December 31, 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 的還有總裁兼執行長 Doug Godshall；艾薩克‧扎卡里亞斯 (Isaac Zacharias)，總裁兼商務長；和財務長 Renee Gaeta。今天早些時候，Shockwave 發布了截至 2023 年 12 月 31 日的季度和年度財務業績。新聞稿的副本可在 Shockwave 網站上取得。

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 statements of historical fact are forward-looking statements.

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。

All forward-looking statements, including, without limitation, statements relating to our sales and operating trends, business and hiring prospects, financial and revenue expectations, clinical trials, reimbursement proposals and future product development and approvals are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties, including the impact of global business, political and macroeconomic conditions that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

所有前瞻性陳述，包括但不限於與我們的銷售和營運趨勢、業務和招聘前景、財務和收入預期、臨床試驗、報銷建議以及未來產品開發和批准有關的陳述，均基於我們當前的估計和各種假設。這些陳述涉及重大風險和不確定性，包括全球商業、政治和宏觀經濟狀況的影響，這些影響可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件有重大差異。

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. On today's call, we will refer to both GAAP financial measures and adjusted EBITDA, a non-GAAP financial measure. Please refer to today's press release for a reconciliation of net income to adjusted EBITDA and additional disclosures regarding this non-GAAP financial measure.

因此，您不應過度依賴這些陳述。有關與我們業務相關的風險和不確定性的清單和描述，請參閱我們向SEC 歸檔並可在EDGAR 上取得的10-K 表格年度報告中的風險因素部分，以及我們定期向SEC 提交的其他報告中的風險因素部分。美國證券交易委員會。在今天的電話會議上，我們將提及 GAAP 財務指標和調整後 EBITDA（非 GAAP 財務指標）。請參閱今天的新聞稿，以了解淨利潤與調整後 EBITDA 的調節表以及有關此非公認會計原則財務指標的其他揭露。

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, February 15, 2024. And with that, I'll turn the call over to Doug.

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，無論是由於新資訊、未來事件或其他原因。本次電話會議包含時間敏感信息，並且僅截至今天（2024 年 2 月 15 日）直播時準確。接下來，我會將電話轉給 Doug。

Thanks, Debbie. Good afternoon, everyone, and thank you for taking the time to join us to review Shockwave's results for the fourth quarter and the full year of 2023, which proved to be another banner one for the company.

謝謝，黛比。大家下午好，感謝您抽出時間與我們一起回顧 Shockwave 第四季度和 2023 年全年的業績，事實證明，這是該公司的另一個旗幟性業績。

During the year, we launched C2 in Japan. We converted to direct sales forces in Spain, Portugal, Italy and Canada. We launched 2 new products, L6 for peripheral vessels and C2+ for the coronaries. We were granted DRG codes specific to coronary IVL in the inpatient hospital setting, which pay on average about $9,000 more than codes for PCIs without IVL. We acquired and integrated Neovasc and the Reducer product, which is the first device that addresses refractory angina, an often debilitating condition that impacts a large patient population that has no good treatment options, and we raised $750 million in a convertible debt offering.

年內，我們在日本推出了 C2。我們在西班牙、葡萄牙、義大利和加拿大轉變為直銷隊伍。我們推出了 2 個新產品，用於週邊血管的 L6 和用於冠狀動脈的 C2+。我們在住院醫院環境中獲得了針對冠狀動脈 IVL 的 DRG 代碼，比沒有 IVL 的 PCI 代碼平均多支付約 9,000 美元。我們收購並整合了Neovasc和Reducer產品，這是第一個解決難治性心絞痛的設備，難治性心絞痛是一種經常使人衰弱的疾病，影響大量沒有良好治療選擇的患者群體，我們通過可轉換債券發行籌集了7.5億美元。

We achieved record revenue of $203 million in the fourth quarter, which was a 41% increase from a year ago, and a 9% sequential increase from the third quarter of 2023. Our revenue for the full year of 2023 was $730.2 million, a 49% increase from 2022 revenue. We witnessed excellent performance in all areas of the business, with U.S. peripheral and coronary businesses growing 47% and 41%, respectively, and our international IVL business growing 75% compared to 2022. Really stellar performance.

我們在第四季實現創紀錄的營收 2.03 億美元，比去年同期成長 41%，比 2023 年第三季季增 9%。我們 2023 年全年的營收為 7.302 億美元，比去年同期成長 49%。較2022 年營收成長%。我們在各個業務領域都取得了出色的業績，與 2022 年相比，美國外周血和冠狀動脈業務分別增長了 47% 和 41%，國際 IVL 業務增長了 75%。表現非常出色。

The team continues to execute at a high level, and we now have over 1,500 global employees. Our products are approved in 70 countries, and we are pleased that we now have EU MDR certification for M5+, S4 and C2+ catheters and our generator. The MDR process was a long journey and required a major effort by the team.

團隊持續保持高水準執行力，目前我們在全球擁有超過 1,500 名員工。我們的產品在 70 個國家/地區獲得批准，我們很高興現在 M5+、S4 和 C2+ 導管以及發生器獲得了歐盟 MDR 認證。 MDR 過程是一個漫長的過程，需要團隊付出巨大的努力。

Our U.S. coronary business continues to shine, and we have a couple of meaningful reimbursement tailwinds that will support continued adoption. The new hospital inpatient DRGs for coronary went into effect in the fourth quarter of last year and additionally, physicians are now being paid when they use coronary IVL thanks to the CPT code that became effective on January 1 of this year. As we have witnessed in the past, reimbursement takes time to influence customer behavior, but we anticipate that the combination of these new payments will have a positive impact on our U.S. coronary business and will help lower the economic friction that has historically been the biggest constraint on increased utilization of IVL.

我們的美國冠狀動脈業務繼續表現出色，我們有一些有意義的報銷優勢，將支援繼續採用。新的冠狀動脈住院患者 DRG 於去年第四季度生效，此外，由於今年 1 月 1 日生效的 CPT 代碼，醫生在使用冠狀動脈 IVL 時現在可以獲得報酬。正如我們過去所見，報銷需要時間來影響客戶行為，但我們預計這些新付款的結合將對我們的美國冠狀動脈業務產生積極影響，並將有助於減少歷史上最大的限制因素的經濟摩擦增加IVL 的利用率。

We anticipate that physicians will increasingly use C2+ whenever they feel it's clinically appropriate, versus feeling pressured to only use it selectively or after exhausting all other options. We believe an IVL-first strategy is optimal for patients and is now even better economically for customers. Also on the coronary topic, we are continuing the launch of C2+, which has 50% more pulses than its predecessor C2. Isaac will talk a bit more about this later in the call, but early reception from our customers has been very positive.

我們預計，只要醫生認為 C2+ 在臨床上合適，他們就會越來越多地使用 C2+，而不是因為有壓力而選擇性地使用它或在用盡所有其他選擇後才使用它。我們相信 IVL 優先策略對患者來說是最佳選擇，現在對客戶來說更經濟。同樣在冠狀動脈主題上，我們將繼續推出 C2+，其脈衝數比其前身 C2 多 50%。艾薩克稍後將在電話中詳細討論這一點，但我們客戶的早期反應非常積極。

On the U.S. peripheral side, the prior authorization issue appears to have stabilized as our customers are learning how to navigate Aetna's increased scrutiny on peripheral procedures, and we have not seen any other payers follow Aetna's practices. Meanwhile, multiple medical societies have come together to form a working group, and they have been applying pressure on Aetna in hopes of getting them to reconsider their policy.

在美國外圍地區，事先授權問題似乎已經穩定下來，因為我們的客戶正在學習如何應對 Aetna 對外圍程序加強的審查，並且我們沒有看到任何其他付款人遵循 Aetna 的做法。與此同時，多個醫學協會聯合起來成立了一個工作小組，他們一直在向 Aetna 施加壓力，希望讓他們重新考慮他們的政策。

There also has been considerable attention paid to Medicare Advantage recently. At the federal level, CMS recently announced new rules, which will make it harder to pursue prolonged prior authorization practices. There also has been some predictive recent movement among commercial payers specific to Shockwave, as HUMANA, the second largest Medicare Advantage payer, issued a positive coverage decision for IVL for their Medicare Advantage plans effective January 1, 2024.

最近，醫療保險優勢也受到了相當多的關注。在聯邦層面，CMS 最近宣布了新規則，這將使長期的事先授權做法變得更加困難。最近，特定於Shockwave 的商業付款人也出現了一些預測性的變化，因為第二大Medicare Advantage 付款人HUMANA 為其Medicare Advantage 計劃發布了一項積極的IVL 承保決定，該決定於2024 年1 月1日生效。

Staying on the topic of U.S. peripheral reimbursement, we are pleased to see that CMS improved hospital reimbursement by assigning peripheral IVL to new MS-DRGs. These new DRGs increased inpatient hospital payment by $4,000 to $10,000 over previous levels. Most peripheral interventions are performed in an outpatient setting. However, a majority of the hospital-based below-the-knee procedures are for the more severe chronic limb-threatening ischemia or CLTI, which makes them more likely to be performed on an inpatient basis than other procedures.

繼續討論美國外圍設備報銷的話題，我們很高興看到 CMS 透過將外圍設備 IVL 分配給新的 MS-DRG 來改善醫院報銷。這些新的 DRG 使住院費用比之前的水平增加了 4,000 美元至 10,000 美元。大多數的週邊介入都是在門診環境中進行。然而，大多數醫院的膝下手術都是針對更嚴重的慢性肢體威脅性缺血或 CLTI，這使得它們比其他手術更有可能在住院患者中進行。

This reimbursement uplift nicely complements the upcoming advances in our below-the-knee product offering that starts later this year. While on the topic of new products, we will be focusing back on peripheral in the second half of this year with 2 launches. First, we will introduce an upgraded version of L6, which will go from 1 pulse per second to 2. We witnessed a very positive response from our customers when we made this same upgrade going from M5 to M5+.

此次報銷的提高很好地補充了我們今年稍後開始的膝以下產品系列即將推出的進步。在談到新產品的話題時，我們將在今年下半年將注意力重新集中在外圍設備上，推出 2 款產品。首先，我們將推出 L6 的升級版本，從每秒 1 個脈衝增加到 2 個脈衝。當我們從 M5 升級到 M5+ 時，我們看到了客戶的非常積極的反應。

Shortly after the L6 rollout, we plan to launch the E8 peripheral catheter. E8 has an 8-centimeter long treatment zone, which is twice as long as our current S4 offering and is specifically designed to treat longer diffuse lesions that are common and below-the-knee cases. We look forward to seeing our customers' response to E8. We think they're going to love it. Rounding out our future BTK offering, we anticipate the approval of our JAVELIN peripheral catheter in the latter part of the year and look forward to starting the limited market release of that product prior to an expected full market release in early 2025.

L6 推出後不久，我們計劃推出 E8 外周導管。 E8 具有 8 公分長的治療區，是我們目前 S4 產品的兩倍，專為治療常見和膝蓋以下病例的較長瀰漫性病變而設計。我們期待看到客戶對 E8 的反應。我們認為他們會喜歡它。為了完善我們未來的 BTK 產品，我們預計 JAVELIN 外周導管將在今年下半年獲得批准，並期待在 2025 年初全面市場發布之前開始該產品的有限市場發布。

That makes 3 significant new peripheral launches within the next year. And finally, on the operations front. Our facility in Costa Rica has gone from first shovel in the ground in June of 2022 to a validated clean room and C2+ line in December of 2023. Amazing progress, frankly. We'll be hosting regulatory audits starting this month and anticipate shipping finished product into inventory in the third quarter of this year. 2023 was a great year for Shockwave, and we are even more excited about what lies ahead in 2024.

這使得明年將推出 3 款重要的新周邊。最後，在營運方面。我們在哥斯達黎加的工廠已從 2022 年 6 月的第一把鏟子落地到 2023 年 12 月經過驗證的無塵室和 C2+ 生產線。坦白說，這是驚人的進展。我們將從本月開始進行監管審計，並預計在今年第三季將成品運送到庫存中。 2023 年對 Shockwave 來說是偉大的一年，我們對 2024 年的前景更加興奮。

We expect revenue between $910 million to $930 million for the full year of 2024, representing growth of 25% to 27% over 2023. Before I turn the call over to Isaac to provide more color on the commercial front, I want to take a minute to thank our outgoing CFO, Dan Puckett, for the tremendous job he has done in his 8 years at Shockwave. During his time here, he was instrumental in our growth from a small pre-revenue private company to a public company with over $700 million in revenue.

我們預計2024 年全年收入將在9.1 億至9.3 億美元之間，比2023 年增長25% 至27%。在我將電話轉給艾薩克提供更多商業方面的信息之前，我想花一點時間感謝我們即將離任的財務長 Dan Puckett 在 Shockwave 的 8 年裡所做的出色工作。在他任職期間，他幫助我們從一家尚未獲利的小型私人公司成長為一家收入超過 7 億美元的上市公司。

Dan is not only a fantastic CFO, but he is a joy to work with. He's been the biggest cheerleader for all of us, always supportive and inspiring to everyone around him and he will be sorely missed. We wish Dan well in his retirement and are pleased to introduce our new CFO, Renee Gaeta, who is jumping right in today, and will present the financials a bit later in the call. And if he gets anything wrong, it's all Dan's fault. With that, I'll turn the call over to Isaac.

Dan 不僅是一位出色的財務官，而且與他共事很愉快。他是我們所有人最大的啦啦隊長，總是支持和激勵他周圍的每個人，我們將非常想念他。我們祝福 Dan 退休後一切順利，並很高興地介紹我們的新任財務長 Renee Gaeta，她今天即將加入，並將在稍後的電話會議中介紹財務數據。如果他做錯了什麼，那都是丹的錯。這樣，我就把電話轉給艾薩克。

Thank you, Doug. Our record results in both the fourth quarter and the full year of 2023 reflect outstanding contributions from our businesses and teams around the globe. Q4 2023 was strong for our U.S. coronary business. Revenue grew 40% compared to Q4 of 2022, 11% sequentially from Q3 of 2023 and 15% sequentially on an average daily sales basis.

謝謝你，道格。我們第四季和 2023 年全年的創紀錄業績反映了我們全球業務和團隊的傑出貢獻。 2023 年第四季我們的美國冠狀動脈業務表現強勁。營收較 2022 年第四季成長 40%，較 2023 年第三季較上季成長 11%，以日均銷售額計算較上季成長 15%。

The C2+ launch is proceeding well. We launched over 1,000 accounts and the product has been very well received. What is particularly appreciated is the utility of more pulses in longer diffuse lesions, eccentric lesions and calcified nodules. We expect continued momentum in the coronary business as our sales team focuses on the C2+ launch and on communicating both the favorable reimbursement changes and additional physician fees for using coronary IVL.

C2+ 的發布進展順利。我們推出了 1,000 多個帳戶，產品廣受好評。特別值得讚賞的是更多脈衝在較長的瀰漫性病變、偏心性病變和鈣化結節的效用。我們預計冠狀動脈業務將繼續保持成長勢頭，因為我們的銷售團隊專注於 C2+ 的推出，並傳達有利的報銷變更和使用冠狀動脈 IVL 的額外醫生費用。

Revenue from our U.S. peripheral business in Q4 2023 was up 19% from a year ago, flat sequentially compared to Q3 and up 3% sequentially on an average daily sales basis. As Doug mentioned, we are seeing a stabilization of the prior authorization dynamic as providers are getting better at navigating the additional steps required for some patients. We continue to expect modest growth in the U.S. peripheral business in the first half of 2024 as we maintained a strong focus on the U.S. coronary business. We did anticipate accelerated U.S. peripheral growth in the second half of 2024 with the L6 and E8 product launches.

2023 年第四季度，我們的美國週邊業務營收年增 19%，與第三季持平，以每日平均銷售額計算，季增 3%。正如 Doug 所提到的，我們看到事先授權的動態趨於穩定，因為醫療服務提供者在處理某些患者所需的額外步驟方面做得越來越好。由於我們繼續高度關注美國冠狀動脈業務，我們繼續預計 2024 年上半年美國週邊業務將溫和成長。我們確實預計，隨著 L6 和 E8 產品的推出，美國週邊地區的成長將在 2024 年下半年加速。

Turning to our international business. We had another record quarter of IVL sales as revenue was up 67% from a year ago, and 14% sequentially compared to Q3. We are now direct in all 5 major European markets: Germany, the U.K., Spain, Italy and France. Sales in Germany doubled during 2023 due to the improved coronary reimbursement. We are starting to see increased usage in some of the smaller German accounts, which can now afford IVL. Germany is the largest market in Europe, and we think there is tremendous upside for coronary penetration from the current level of just over 2%.

轉向我們的國際業務。我們的 IVL 銷售季度再創新高，營收比去年同期成長 67%，比第三季季增 14%。我們現在直營歐洲所有 5 個主要市場：德國、英國、西班牙、義大利和法國。由於冠心病報銷的改善，德國的銷售額在 2023 年翻了一番。我們開始看到一些較小的德國帳戶的使用量增加，這些帳戶現在可以負擔 IVL。德國是歐洲最大的市場，我們認為冠狀動脈滲透率比目前略高於 2% 的水平有巨大的上升空間。

We had our first full quarter of direct sales in Italy and are very pleased with the execution by that team. It feels good to see such strong and seamless execution from the direct selling teams in Europe. We continue to drive penetration with the focus of the Shockwave sales team and the support of our marketing and physician education programs.

我們在義大利實現了第一個完整季度的直銷，對團隊的執行感到非常滿意。看到歐洲直銷團隊如此強大且無縫的執行力真是太好了。在 Shockwave 銷售團隊的關注以及我們的行銷和醫生教育計劃的支持下，我們繼續推動滲透率。

In Japan, we completed our first year of coronary sales. We exceeded our goals for the number of accounts launched, the penetration in the launched accounts and revenue. We have initiated efforts to develop clinical data that will support using IVL in conjunction with atherectomy and drug-coated balloons. We are working closely with CVIT, the interventional cardiology society in Japan, to ensure that IVL is available and appropriately used throughout Japan.

在日本，我們完成了冠狀動脈銷售的第一年。我們在啟動帳戶數量、啟動帳戶滲透率和收入方面超出了目標。我們已開始努力開發臨床數據，以支援將 IVL 與斑塊旋切術和藥物塗層球囊結合使用。我們正在與日本介入性心臟病學會 CVIT 密切合作，以確保 IVL 在日本各地可用並適當使用。

In China, we are still experiencing the impact of the ongoing anti-corruption campaign, which is slowing IVL adoption at new centers. On the positive side, adoption within centers that had IVL on the pricing list before the anti-corruption campaign started is growing nicely. That said, we expect very little revenue from China in the first half of 2024.

在中國，我們仍在經歷持續的反腐敗運動的影響，這減緩了新中心對 IVL 的採用。從積極的一面來看，在反腐敗運動開始之前將 IVL 列入定價清單的中心的採用率增長良好。儘管如此，我們預計 2024 年上半年來自中國的收入很少。

Finally, the European Reducer team posted a very nice quarter. The teams in Germany and France are being rebuilt, and along with the established U.K. team, continue to generate revenue while testing different market development strategies and sales models. We are very pleased with the integration of Neovasc and are starting 2024 with strong teams in place to both accelerate enrollment in the COSIRA-II trial and build the international Reducer business. With that, I will turn the call to Renee to review the financials.

最後，歐洲Reducer團隊發布了非常好的季度報告。德國和法國的團隊正在重建，並與已建立的英國團隊一起繼續創造收入，同時測試不同的市場開發策略和銷售模式。我們對 Neovasc 的整合感到非常高興，並從 2024 年開始組建強大的團隊，以加快 COSIRA-II 試驗的註冊速度並建立國際減速器業務。這樣，我就會打電話給蕾妮，讓她審查財務狀況。

Thank you, Isaac, and good afternoon, everyone. I am thrilled to have joined the Shockwave team and look forward to working with all of you. Shockwave Medical's revenue for the fourth quarter ended December 31, 2023, was $203 million. a 41% increase from $144 million in the fourth quarter of 2022. U.S. revenue was $158.1 million in the fourth quarter of 2023, an increase of 34% from $118.3 million in the fourth quarter of 2022.

謝謝你，艾薩克，大家下午好。我很高興加入 Shockwave 團隊，並期待與大家合作。 Shockwave Medical 截至 2023 年 12 月 31 日的第四季營收為 2.03 億美元。較 2022 年第四季的 1.44 億美元成長 41%。2023 年第四季 美國營收為 1.581 億美元，較 2022 年第四季的 1.183 億美元成長 34%。

Coronary products contributed $115.2 million to U.S. revenue in the fourth quarter of 2023, an increase of 40% from $82.1 million in the fourth quarter of 2022. U.S. revenue from our peripheral products was $42.8 million in the fourth quarter of 2023, an increase of 19% from $36 million in the fourth quarter of 2022. The growth in U.S. revenue during the quarter was driven primarily by increased utilization at existing accounts, supported by our continued sales force expansion.

冠脈產品在2023 年第四季為美國貢獻了1.152 億美元的收入，比2022 年第四季的8,210 萬美元成長了40%。2023 年第四季我們的外圍產品在美國的收入為4,280 萬美元，成長了19%與 2022 年第四季的 3,600 萬美元相比，成長了 %。本季美國收入的成長主要是由於現有帳戶利用率的提高，以及我們持續的銷售隊伍擴張的支持。

International revenue was $44.8 million in the fourth quarter of 2023, representing a 74% increase from $25.7 million in the fourth quarter of 2022. Coronary products contributed $37.7 million to international revenue in the fourth quarter of 2023, an 83% increase from $20.6 million in the fourth quarter of 2022. International revenue from our peripheral products was $5.3 million in the fourth quarter of 2023, an increase of 19% from $4.5 million in the fourth quarter of 2022.

2023 年第四季的國際營收為4,480 萬美元，比2022 年第四季的2,570 萬美元成長74%。冠脈產品在2023 年第四季為國際營收貢獻了3,770 萬美元，比2022 年第四季季度的2,060 萬美元成長了83%。2022 年第四季。2023 年第四季我們的外圍產品的國際營收為 530 萬美元，比 2022 年第四季的 450 萬美元成長 19%。

Our Reducer product contributed $1.8 million to international revenue in the fourth quarter of 2023. The increase in international revenue over the prior year period was driven by a continued geographic expansion, particularly in Japan, the increased productivity of our direct selling teams in Europe and the momentum from our C2+ launch.

我們的Reducer產品在2023年第四季為國際收入貢獻了180萬美元。國際收入較上年同期的成長是由於持續的地理擴張（特別是在日本）、我們在歐洲的直銷團隊的生產力提高以及我們的C2+ 發布帶來的動力。

Looking at product lines, our peripheral products, Shockwave M5, Shockwave M5+, Shockwave S4 and Shockwave L6, accounted for $48.1 million of total revenue in the fourth quarter of 2023 compared to $40.5 million in the fourth quarter of 2022, a 19% increase. Our coronary products, Shockwave C2 and Shockwave C2+, accounted for $152.9 million of total revenue in the fourth quarter of 2023 compared to $102.7 million in the fourth quarter of 2022, representing a 49% increase. Revenue from our Reducer product accounted for $1.8 million of total revenue in the fourth quarter of 2023.

從產品線來看，我們的周邊產品Shockwave M5、Shockwave M5+、Shockwave S4和Shockwave L6在2023年第四季的總營收中佔4,810萬美元，而2022年第四季為4,050萬美元，成長了19%。我們的冠脈產品 Shockwave C2 和 Shockwave C2+ 在 2023 年第四季的總營收中佔 1.529 億美元，而 2022 年第四季為 1.027 億美元，成長了 49%。 2023 年第四季度，Reducer 產品的營收佔總營收 180 萬美元。

Gross profit for the fourth quarter of 2023 was $177.7 million compared to $126.5 million in the fourth quarter of 2022. Gross margin was 88% for the fourth quarter of 2023, consistent with gross margin of 88% for the fourth quarter of 2022. Total operating expenses for the fourth quarter of 2023 were $134.4 million, a 60% increase from $84.1 million in the fourth quarter of 2022.

2023 年第四季的毛利為 1.777 億美元，而 2022 年第四季為 1.265 億美元。2023 年第四季的毛利率為 88%，與 2022 年第四季的毛利率 88% 一致。2023年第四季的支出為1.344億美元，比2022年第四季的8,410萬美元成長60%。

Sales and marketing expenses for the fourth quarter of 2023 were $67.2 million compared to $43.4 million in the fourth quarter of 2022. The increase was primarily driven by sales force expansion. R&D expenses in the fourth quarter of 2023 were $42.3 million compared to $23.7 million in the fourth quarter of 2022. The increase was primarily driven by head count growth, higher clinical-related expenses, including Reducer, and the facility expansion to support R&D.

2023 年第四季的銷售和行銷費用為 6,720 萬美元，而 2022 年第四季為 4,340 萬美元。這一成長主要是由銷售隊伍擴張所推動的。 2023 年第四季的研發費用為4,230 萬美元，而2022 年第四季為2,370 萬美元。這一增長主要是由於人員數量增長、包括Reducer 在內的臨床相關費用增加以及支持研發的設施擴建所致。

General and administrative expenses for the fourth quarter of 2023 were $24.9 million compared to $17 million in the fourth quarter of 2022. The increase was primarily driven by higher head count to support the growth of the business. Operating margin was 21% for the fourth quarter of 2023. Net income in the fourth quarter of 2023 was $44.3 million compared to net income of $140.9 million in the fourth quarter of 2022.

2023 年第四季的一般及管理費用為 2,490 萬美元，而 2022 年第四季為 1,700 萬美元。這一成長主要是由於支持業務成長的員工人數增加所致。 2023 年第四季的營業利潤率為 21%。2023 年第四季的淨利潤為 4,430 萬美元，而 2022 年第四季的淨利潤為 1.409 億美元。

In the fourth quarter of 2022, we released a valuation allowance, which resulted in a tax benefit of $99 million in that quarter. Basic net income per share for the period was $1.20. Diluted net income per share for the period was $1.16. Adjusted EBITDA was $68.2 million for the fourth quarter of 2023, a 20% increase compared to adjusted EBITDA of $56.6 million in the fourth quarter of 2022.

2022 年第四季度，我們發布了估值津貼，該季度帶來了 9,900 萬美元的稅收優惠。該期間每股基本淨利潤為 1.20 美元。該期間稀釋後每股淨利潤為 1.16 美元。 2023 年第四季調整後 EBITDA 為 6,820 萬美元，比 2022 年第四季調整後 EBITDA 5,660 萬美元成長 20%。

Finally, I'd like to briefly recap some highlights from our full year 2023 results. Total revenue for the full year 2023 was $730.2 million, an increase of 49% compared to full year 2022 revenue of $489.7 million. U.S. revenue for the full year 2023 was $581.5 million, representing a 43% increase over 2022 revenue of $407.4 million. International revenue was $148.7 million for the full year of 2023 compared to $82.3 million in 2022, representing an 81% increase. Gross margin for the full year 2023 was 87%, consistent with 87% for the full year 2022.

最後，我想簡要回顧一下我們 2023 年全年業績的一些亮點。 2023 年全年總營收為 7.302 億美元，較 2022 年全年營收 4.897 億美元成長 49%。 2023 年美國全年營收為 5.815 億美元，比 2022 年 4.074 億美元的營收成長 43%。 2023 年全年國際營收為 1.487 億美元，較 2022 年的 8,230 萬美元成長 81%。 2023 年全年毛利率為 87%，與 2022 年全年毛利率 87% 一致。

Total operating expenses were $475.7 million in 2023, an increase of 58% compared to operating expenses of $300.6 million in 2022. Operating margin was 22% for the full year 2023. Total net income for the full year 2023 was $147.3 million compared to $216 million for the full year 2022. Net income in 2022 included the $99 million tax benefit from the aforementioned release of our valuation allowance. Basic net income per share was $4.01 for the full year 2023. Diluted net income per share was $3.85 for the full year 2023. Adjusted EBITDA was $242.7 million for the full year 2023, a 40% increase from adjusted EBITDA of $173.9 million for the full year 2022.

2023 年總營運費用為4.757 億美元，與2022 年營運費用3.006 億美元相比成長58%。2023 年全年營運利潤率為22%。2023 年全年淨利潤總額為1.473 億美元，而2022 年為2.16 億美元2022 年全年。2022 年的淨利潤包括上述我們的估值津貼發布帶來的 9,900 萬美元稅收優惠。 2023 年全年每股基本淨利為4.01 美元。2023 年全年稀釋每股淨利為3.85 美元。2023 年全年調整後EBITDA 為2.427 億美元，較2023 年全年調整後EBITDA 1.739 億美元成長40% 2022 年。

Looking forward to 2024, we expect to continue to make significant investments to support and sustain our growth and anticipate full year 2024 operating margin expansion of up to 100 basis points from the full year of 2023. Similar to the pattern we saw in 2023, we do expect a step-down in Q1 operating margin from the prior Q4, reflecting compensation and benefits costs, which reset at the beginning of the year as well as the timing and increased costs related to our global sales meeting held in March. We ended the fourth quarter of 2023 with $990.6 million in cash, cash equivalents and short-term investments.

展望2024 年，我們預計將繼續進行重大投資，以支持和維持我們的成長，並預計2024 年全年營業利潤率將比2023 年全年增長100 個基點。與我們在2023 年看到的模式類似，我們確實預計第一季的營業利潤率將較上一季度有所下降，這反映出年初重置的薪酬和福利成本以及與 3 月份舉行的全球銷售會議相關的時間安排和成本增加。截至 2023 年第四季度，我們的現金、現金等價物和短期投資為 9.906 億美元。

At this point, I'd like to turn the call back over 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, Renee, and thank you all for joining us today. 2023 was another great year at Shockwave. The team continues to execute at the highest level as we achieve our mission to help treat underserved patient populations around the globe with our innovative solutions, and we're excited to continue this work in 2024. With that, I'd like to open the call to questions.

謝謝你，蕾妮，也謝謝大家今天加入我們。 2023 年對 Shockwave 來說又是偉大的一年。團隊繼續以最高水準執行任務，以實現我們的使命，透過我們的創新解決方案幫助治療全球服務不足的患者群體，我們很高興能夠在 2024 年繼續開展這項工作。就此，我想開啟致電提問。

(Operator Instructions) Our first question comes from the line of Adam Maeder with Piper Sandler.

（操作員說明）我們的第一個問題來自 Adam Maeder 和 Piper Sandler。

Nice quarter, and congrats on a fantastic year and welcome, Renee, on the new role. I wanted to start on the guidance construction, the top line, $910 million to $930 million. Maybe just talk about what's embedded for some of the different pieces of the business? Coronary versus peripheral versus Reducer?

美好的季度，恭喜您度過了美好的一年，並歡迎蕾妮擔任新職務。我想從指導建設開始，即頂線，9.1 億至 9.3 億美元。也許只是談談業務的一些不同部分嵌入了什麼？冠狀動脈、週邊血管還是減速機？

And if I heard correctly, you said modest U.S. peripheral growth in the first half of '24, then accelerate in the back half with new product launches. Hoping you could flesh that out some. I'm assuming that's assuming some continued headwinds from Aetna, but wanted to, I guess, kind of understand what's baked in to the guide for Aetna prior auths as well as China anti-corruption. Any potential impact from the step-down in outpatient reimbursement on the coronary side in the back half of the year? I'm sorry for the long-winded question.

如果我沒聽錯的話，您說美國外圍國家在 24 年上半年出現溫和成長，然後在下半年隨著新產品的推出而加速成長。希望你能充實一些。我假設這是假設安泰保險持續存在一些阻力，但我想，我想了解安泰保險先前授權以及中國反腐敗指南中包含的內容。下半年冠心病門診報銷的下調有何潛在影響？我很抱歉問了這個冗長的問題。

Yes. So -- and we'll probably tag team on this. We are anticipating modest growth on peripheral particularly in the first couple of quarters while we concentrate on coronary. And then as we start launching L6 and E8 and turn our focus back to peripheral, we'll start seeing a step up in peripheral growth. The year will be another really strong year we anticipate for U.S. coronary contribution as a percent of the business. We anticipate U.S. coronary will be actually a larger percent of the total business than it was end of -- throughout the 2023.

是的。所以——我們可能會在這方面標記團隊。我們預計週邊疾病將出現適度增長，特別是在前幾個季度，而我們將重點關注冠狀動脈。然後，當我們開始推出 L6 和 E8 並將重點轉向外圍設備時，我們將開始看到外圍設備成長的步伐。我們預計，今年美國冠狀動脈貢獻佔業務的百分比將是另一個非常強勁的一年。我們預計，到 2023 年，美國冠狀動脈業務實際上在總業務中所佔的比例將比年底更大。

We obviously had a very strong international performance last year. We anticipate another strong year, although we have the China deficit. So ex China, international is going to do very well, but we'll be losing over $10 million in -- somewhere between $10 million and $20 million in revenue that we would have -- that we had last year in China that we're not going to get this year. So we're anticipating sort of very low single-digit revenue out of China. So ex China, another strong contribution year from the international business. And I kind of know...

顯然，去年我們在國際上的表現非常強勁。儘管我們對中國存在逆差，但我們預計將迎來強勁的一年。因此，除中國外，國際業務將會做得很好，但我們將損失超過 1000 萬美元——我們去年在中國的收入將在 1000 萬美元到 2000 萬美元之間。今年不會得到。因此，我們預計中國的收入將非常低，僅為個位數。除中國外，今年是國際業務做出強勁貢獻的另一年。我有點知道...

Last point, Adam, you asked about was on the outpatient -- for coronary U.S. in the second half, the outpatient payment? We don't anticipate. I mean we're aware of the situation, obviously. We still expect baseline is that the TPT will -- is set to expire July 1, and it will expire July 1.

Adam，你問的最後一點是關於門診的——對於美國冠狀病毒下半年來說，門診費用是多少？我們不預測。我的意思是，顯然我們已經了解情況。我們仍然預期 TPT 的基線是定於 7 月 1 日到期，並且將於 7 月 1 日到期。

We still anticipate the up leveling to 5194 will occur Jan 1 of 2025, but what we've seen typically with reimbursement in the U.S. is it takes time to move behavior and change behavior patterns and what -- so we've not been on this kind of good, good run in coronary, and we have a really strong coronary business and momentum right now, with the inpatient reimbursement continue to be a tailwind, the physician fee continue to be a tailwind, the C2+ launch is a tailwind, and we just don't anticipate that having the TPT expire in the middle of the year will be much of a headwind, TBD, but that's kind of what we've seen in our -- that's what we've baked into our guidance.

我們仍然預計 2025 年 1 月 1 日將升級至 5194，但我們在美國的報銷中通常看到的是，改變行為和改變行為模式需要時間，所以我們還沒有關注這個問題冠狀動脈業務運作良好，我們現在擁有非常強大的冠狀動脈業務和勢頭，住院報銷繼續是順風，醫生費用繼續是順風，C2+的推出是順風，我們只是不要預期TPT 在年中到期會帶來很大的阻力，待定，但這就是我們在我們的指導中看到的情況——這就是我們納入指導的內容。

Yes. That's good color, guys. And for the follow-up, we'll stick with the guidance topic and switch over to margins. If I heard correctly, you're expecting up to 100 basis points of operating margin expansion for full year '24 over '23 levels. That's a little bit below kind of where The Street is pre-call.

是的。夥計們，這個顏色很好。對於後續行動，我們將堅持指導主題並切換到邊距。如果我沒聽錯的話，您預計 24 年全年營業利潤率將比 23 年水準提高 100 個基點。這比《華爾街日報》預審的情況要低一些。

Maybe I would just love to hear a little bit more about kind of what's embedded in that assumption. Should we be orienting models to kind of 50 basis points kind of the midpoint of that range? Or should we start at 100 basis points kind of coming out of the Q4 call here? And yes, I just would love to hear a little bit more about the philosophy on the leverage piece.

也許我只是想聽聽更多關於該假設的內容。我們是否應該將模型調整為 50 個基點（即該範圍的中點）？或者我們應該從第四季電話會議中得出的 100 個基點開始？是的，我只是想聽聽更多關於槓桿原理的資訊。

So we -- as usual, we're going to continue investing in aggressively in our pipeline, both on the sort of hardcore product development side, and increasingly, the clinical trial expenses, which whether it's the trial for Reducer, the COSIRA-II study or the various trials such as DUO that we're running now, or EMPOWER.

因此，像往常一樣，我們將繼續在我們的產品線中積極投資，無論是在硬核產品開發方面，還是在臨床試驗費用方面，無論是Reducer、COSIRA-II 的試驗研究或各種試驗，例如我們現在正在運行的DUO 或EMPOWER。

We initiated multiple trials next year and they're becoming more expensive -- last year. And this year, we'll spend even more on those trials. So big step-up in clinical spend. We'll continue to augment our global sales footprint, but the U.S. team will not be growing at the same rate that it has historically. We've -- we're not done building out that team, but the rate of change will be lower.

我們明年啟動了多項試驗，去年它們變得更昂貴。今年，我們將在這些試驗上投入更多。臨床支出大幅增加。我們將繼續擴大我們的全球銷售足跡，但美國團隊的成長速度將不會像歷史上那樣。我們還沒有完成該團隊的建設，但變化的速度會更低。

So the -- so you'll probably see a little leverage on sales, sort of not incremental leverage on R&D. We shouldn't see much deleveraging on R&D, but that will probably be static relative to the top line. We're still spending money right now. We're still having to expense Costa Rica, and that does not convert into inventory until later in the year. And so we're still having to absorb Costa Rica costs, which are not insignificant.

因此，您可能會看到對銷售的一點影響，而不是對研發的增量影響。我們不應該看到研發方面出現太多去槓桿化，但這可能相對於營收來說是靜態的。我們現在還在花錢。我們仍然需要花費哥斯達黎加的費用，而這要到今年稍後才會轉化為庫存。因此，我們仍然必須承擔哥斯達黎加的成本，這並不是微不足道的。

I got it. And just one clarification, Doug, no change to the 500 basis points operating margin expansion over '23 levels that you outlined at the Innovation Day last year. I just wanted to confirm that's still the case.

我得到了它。道格，我只想澄清一下，您在去年創新日上概述的 23 個水平上營業利潤率擴張 500 個基點的情況沒有變化。我只是想確認情況仍然如此。

Yes. We've been -- we've articulated previously that it's going to be '25, '26. We're pleased that -- if this plan delivers as expected, we're very pleased with a up to 100 basis point improvement. If you want to model 50, I'm perfectly okay with that. And we'll obviously try to do better, but we're targeting top line growth, as our objective, not -- we think the margin improvement is really an output of the business versus the specific objective of the business.

是的。我們之前已經明確表示，這將是「25」、「26」。我們很高興 - 如果該計劃按預期交付，我們對高達 100 個基點的改進感到非常高興。如果你想要 50 的模型，我完全可以接受。顯然，我們會努力做得更好，但我們的目標是營收成長，而不是——我們認為利潤率的提高實際上是業務的產出與業務的具體目標的比較。

Our next question comes from the line of Bill Plovanic with Canaccord.

我們的下一個問題來自 Bill Plovanic 與 Canaccord 的對話。

Great. Just a couple of things here. you gave us a little granularity on what you're seeing from Aetna. And just what do you think in terms of when this comes back? Is this just like a 3-, 6-, 9-month delay? Or does this take patients out of the funnel? Or does it come back at some point in time? How should we think about just Aetna going forward?

偉大的。這裡只有幾件事。您向我們詳細介紹了您從 Aetna 看到的情況。當這種情況再次出現時，您有何看法？這就像延遲 3、6、9 個月嗎？或者這會讓患者脫離漏斗？或者它會在某個時間點回來嗎？我們該如何看待 Aetna 的未來？

Yes, I'm going to answer this and bring in Rob Fletcher as well to add color. What's unknowable for us is, is a patient -- is an Aetna Shockwave patient that got treated today somebody who would have been treated 4 months ago, 2 months ago, 1 month ago? Don't know. It's impossible for us to have that level of granularity. And maybe Rob can talk a bit more about sort of what he's seeing more broadly on -- from our team and from societies on this prior auth.

是的，我要回答這個問題，並請羅布·弗萊徹來增添色彩。我們不知道的是，今天接受治療的 Aetna Shockwave 患者是否是 4 個月前、2 個月前、1 個月前接受治療的患者？不知道。我們不可能達到這種程度的粒度。也許羅伯可以更多地談論他從我們的團隊和先前的認證中更廣泛地看到的東西。

Yes, that's right, Bill. I think what typically happens after a change in practice from one of the payers that are out there is what you see is at the provider level, at the hospital level, there's often a reaction to that. They have to do more documentation or they have to take additional measures or steps or allow for more time to go through a prior authorization process.

是的，沒錯，比爾。我認為，在付款人之一的做法發生變化後，通常會發生什麼，你看到的是在提供者層面、在醫院層面，通常會對此做出反應。他們必須做更多的文件記錄，或必須採取額外的措施或步驟，或留出更多的時間來完成事先的授權流程。

So typically, what we see is over time after some initial sort of temporal disruption, people figure out how to start working within this and then they plan for it. And then it kind of becomes -- back to a steady state. It's kind of a new normal, but you wind up with more of a steady state type of effect. And I think that's what we're seeing and hearing now from customers is that, that has really sort of stabilized. People have figured out how to work within that.

因此，通常情況下，我們看到的是，隨著時間的推移，在一些最初的時間中斷之後，人們會弄清楚如何開始在此範圍內工作，然後他們會制定計劃。然後它就變成了——回到穩定狀態。這是一種新常態，但最終會產生更多穩態類型的效果。我認為這就是我們現在從客戶那裡看到和聽到的情況，情況確實已經穩定下來。人們已經弄清楚瞭如何在其中工作。

Meanwhile, we do see action being taken from the medical societies, for example, who did, over the course of this period, come together. Jointly, there was multiple medical societies, and did issue an additional letter to Aetna that covered a bunch of different things, including this prior authorization practice. So you are starting to see some pushback, and I expect that Aetna will take that under consideration under many other things. But for the time being, I think it's -- I'd describe it as what appears to be more a stable situation at a new normal.

同時，我們確實看到醫學界正在採取行動，例如，醫學界在這段時期確實走到了一起。多個醫學協會共同向 Aetna 發出了一封額外的信函，其中涵蓋了許多不同的內容，包括這種事先授權做法。因此，您開始看到一些阻力，我希望 Aetna 會在許多其他事情中考慮這一點。但就目前而言，我認為這是——我將其描述為新常態下似乎更穩定的情況。

Great. And then as a follow-up, I don't want to leave Renee out on our first conference call. Welcome, Renee. Is -- your other income was significant in the quarter, well above. Can you kind of call out any onetimes there for us?

偉大的。作為後續行動，我不想在我們的第一次電話會議上錯過蕾妮。歡迎，蕾妮。是——你的其他收入在本季很可觀，遠高於。您能隨時幫我們打電話嗎？

Wouldn't necessarily be onetime, but certainly, interest income is within that number and then, of course, our interest expense out on the convertible debt. So that number is going to be nice, given interest rates currently. And thank you for the question.

不一定是一次性的，但可以肯定的是，利息收入在這個數字之內，然後，當然，我們的可轉換債務的利息支出。考慮到目前的利率，這個數字將是不錯的。謝謝你的提問。

So $15.3 million, is that something we should model in going forward?

那麼 1530 萬美元是我們未來應該效法的嗎？

$15.3 million might be a little high. There's probably some FX in there. Yes. So it's slightly high, but there's -- just because of the FX for the period, but it is largely interest income.

1530 萬美元可能有點高。裡面可能有一些FX。是的。所以它有點高，但只是因為這段期間的外匯，但主要是利息收入。

Our next question comes from the line of Patrick Wood with Morgan Stanley.

我們的下一個問題來自帕特里克·伍德與摩根士丹利的對話。

Amazing. Maybe just to hop off on that point. The amount of cash on the balance sheet, I mean you're approaching $1 billion, so it's nearly as much as is in my checking account. And so I got to ask like what do you like -- updated thoughts? I know there was like a willingness to be sort of strategically footed around M&A., so obviously, it's like nearly an eighth of your market cap. How are you thinking about capital allocation?

驚人的。也許只是為了跳到那個點。資產負債表上的現金金額，我的意思是，接近 10 億美元，所以它幾乎與我的支票帳戶中的現金數量一樣多。所以我必須問你喜歡什麼——更新的想法？我知道人們願意圍繞併購進行策略性佈局，所以顯然，這相當於你市值的近八分之一。您如何考慮資本配置？

And if you want to Venmo me, Patrick, I'm receptive. I'll give you my numbers. So yes, we continue to be very receptive to smart strategic external opportunities. Maybe emphasis on smart or trying to be smart, at least. We raised the convert with the -- recognizing that there was a window where valuations for private companies were down, and they still are. It's very hard to raise money for small companies.

如果你想給我打電話，派崔克，我很樂意接受。我會給你我的號碼。所以，是的，我們仍然非常樂於接受明智的策略外部機會。至少可能強調聰明或試圖變得聰明。我們認識到私人公司的估值曾經有一個下降的窗口，而且現在仍然如此，因此我們提高了轉換率。小公司籌集資金非常困難。

And valuations have said private companies were -- and willingness of boards sort of had changed over a 12-, 24-month period. And we didn't -- at middle of last year, we did not have the cash wherewithal to make offers on some -- on properties that we might be interested or thought we might be interested in, and we realized that the convert structure and terms were just so attractive that having a 1% coupon in a period where we can -- we're netting a nice interest income relative to our interest expense right now.

估值顯示，私人公司的董事會意願在 12 至 24 個月期間發生了一定程度的變化。去年年中，我們沒有足夠的現金來對我們可能感興趣或認為我們可能感興趣的一些房產提出報價，我們意識到轉換結構和條款是如此有吸引力，以至於我們可以在一段時間內獲得1 % 的票面利率－相對於我們現在的利息支出，我們獲得了可觀的利息收入。

And we didn't raise the money so that we could invest the money, we raised the money so that we could be opportunistic if something came along. That said, the worst thing you could do is just because you have cash, run out and buy something that is not smart to buy. And so if at the end of the day, we don't see anything that we think is going to be accretive to our growth and accretive to our shareholder value, then we'll sit on the cash until we find something that is worth investing in.

我們籌集資金並不是為了投資，我們籌集資金是為了在出現情況時我們可以投機取巧。也就是說，你能做的最糟糕的事情就是因為你有現金，然後用完併購買一些不明智的東西。因此，如果最終我們看不到任何我們認為能夠促進我們的成長和股東價值的東西，那麼我們將坐擁現金，直到找到值得投資的東西。

That gives us tremendous amount of strategic flexibility that we're -- we feel really fortunate to have for a company at our stage, to be growing at our rate, to be profitable and have this much cash on the books is really -- we recognize the unique position we're in. But we don't feel obligated to run out and spend that money on something because then we would be more likely to do something that wasn't smart.

這給了我們巨大的戰略靈活性，我們感到非常幸運，對於我們這個階段的公司來說，能夠以我們的速度增長，能夠盈利，賬面上有這麼多現金，我們真的很幸運。認識到我們所處的獨特地位。但我們並不覺得有義務把錢花在某些事情上，因為那樣我們就更有可能做一些不明智的事情。

Totally. And maybe as a quick follow-up, the -- slightly more bigger picture, and I know we don't talk about OUS that much, but when do you think you're going to get to a point of a body of clinical evidence that can kind of help unlock some of the penetration in some of the other markets? Obviously, Germany went your way recently, and I know in the U.K., nice sort of reformulated that language around peripheral. But just kind of -- is there like a critical mass of evidence that you feel is needed to unlock the markets? Or is it something else?

完全。也許作為一個快速的後續行動，稍微更大一些的圖景，我知道我們不會太多地談論 OUS，但是你認為你什麼時候才能達到臨床證據的一個點這可以幫助解鎖其他一些市場的滲透率嗎？顯然，德國最近走了你的路，我知道在英國，很好地圍繞外圍重新表達了這種語言。但只是——是否有足夠的證據表明您認為需要解鎖市場？還是別的什麼？

I'll take a shot at that. I think in many of the markets, it's unlikely that at least with our coronary and our peripheral IVL that will amass enough evidence that those systems, kind of the National Health Systems will increase or give extra payment for IVL. I think it's -- those are generally going to need to be large, randomized studies, showing cost effectiveness compared to other products.

我會嘗試一下。我認為在許多市場中，至少對於我們的冠狀動脈和周邊 IVL 來說，不太可能收集足夠的證據來證明這些系統（例如國家衛生系統）將增加或為 IVL 提供額外費用。我認為這些通常需要進行大型隨機研究，以顯示與其他產品相比的成本效益。

And we just don't see those studies being necessary, really, one, but also, we're not -- we talked about this a lot internally. We don't know what to randomize against. Because we don't -- randomizing against the balloon, we don't think is an appropriate study, randomizing against atherectomy, we don't think it's an appropriate study. There are different tools for different clinical situations.

我們只是認為這些研究沒有必要，真的，但是，我們也沒有——我們在內部討論了很多這個問題。我們不知道要隨機化什麼。因為我們不——針對氣球進行隨機化，我們認為這不是一項合適的研究，針對斑塊切除術進行隨機化，我們認為這不是一項合適的研究。針對不同的臨床情況有不同的工具。

So we're working on it. We have -- Japan, we're in a good spot. Obviously, Germany, we're in a good spot. Hopefully continue to get better. Our JV is working on regional reimbursement in China, and we'll make progress there. But I think generally, it's going to be -- IVL is going to be paid for out of kind of hospital funds and the budgets they have to treat to treat patients without any incremental payment for IVL.

所以我們正在努力。我們——日本，我們處於有利位置。顯然，德國，我們處於有利位置。希望繼續變得更好。我們的合資公司正在中國進行區域報銷工作，我們將在那裡取得進展。但我認為一般來說，IVL 將從醫院資金和治療患者的預算中支付，而無需額外支付 IVL。

What will be interesting to see is with COSIRA-II, assuming success in that study. That's exactly the kind of study that the sham-controlled randomized study, again, assuming it works, it will be undeniable that, that product does what it was designed to do and actually increases the chances that Reducer could be -- could get reimbursement in some of those systems.

假設研究取得成功，COSIRA-II 將會很有趣。這正是假對照隨機研究的類型，假設它有效，不可否認的是，該產品達到了其設計目的，並且實際上增加了Reducer可能獲得報銷的機會其中一些系統。

And it's a stand-alone procedure versus IVL that drops into existing procedures that are already paid for, so it's harder outside of certain discrete markets like Germany and Japan and the U.S., it's harder to get an incremental payment in those systems because they're kind of not structured to pay more per device, whereas a small subset of countries do pay differentially based on the way they code for different device utilization.

與IVL 相比，它是一個獨立的程序，它會納入已付費的現有程序中，因此在德國、日本和美國等某些離散市場之外更難，在這些系統中獲得增量付款也更困難，因為它們是某種程度上來說，並不是為每台設備支付更多費用，而一小部分國家確實根據針對不同設備使用情況的編碼方式而支付不同的費用。

Our next question comes from the line of Travis Steed with Bank of America.

我們的下一個問題來自美國銀行的 Travis Steed。

Welcome, Renee. Doug, maybe a little bit more color on what modest peripheral growth means. Is that still in the 10% to 15% range? Or is it more low single digits? And is that modest growth every quarter of the year?

歡迎，蕾妮。道格，也許對外圍適度增長意味著什麼有更多的了解。仍然在 10% 到 15% 的範圍內嗎？還是更低的個位數？每年每季都會有適度的成長嗎？

More modest early. So low -- we think probably low singles for the first half of the year, stepping up to probably low doubles to teens in the back half of the year.

早期比較謙虛。這麼低——我們認為今年上半年的單打可能會很低，下半年的雙打到十幾歲可能會很低。

Okay. Helpful. And then in Q1 -- or sorry, just like in January and February so far, anything to call out on trends in coronary and peripheral? And I'm curious if the total revenue for Q1's still picking up sequentially a little bit.

好的。有幫助。然後在第一季——或者抱歉，就像到目前為止的一月和二月一樣，冠狀動脈和周邊血管的趨勢有什麼值得關注的嗎？我很好奇第一季的總收入是否仍會繼續略有上升。

Yes on the latter. Up a bit sequentially. It was a strong fourth quarter, obviously. We were pleased with the fourth quarter. We're relieved -- not surprised, but encouraged that the contagion fear was not realized. We weren't afraid of contagion from Aetna, but I know a lot of folks who are probably listening to this call we were a little worried that it was going to be multiple payers were going to do what Aetna was doing, and we certainly aren't seeing that. I'd say procedure volumes appear sound. We're not -- we're pleased with what we're hearing from the field.

是的，後者。依序向上一點。顯然，第四季表現強勁。我們對第四季感到滿意。我們鬆了一口氣——並不感到驚訝，而是感到鼓舞，因為人們對傳染的恐懼並未成為現實。我們不害怕來自 Aetna 的傳染，但我知道很多人可能正在聽這個電話，我們有點擔心會有多個付款人會做 Aetna 正在做的事情，我們當然不會沒看到那個。我想說的是，程式音量看起來不錯。我們對從現場聽到的消息感到滿意。

Our next question comes from the line of Larry Biegelsen with Wells Fargo.

我們的下一個問題來自拉里·比格爾森 (Larry Biegelsen) 與富國銀行 (Wells Fargo) 的對話。

Starting, Doug, in the U.S. U.S. coronary accelerated in Q4. How much do you think the new DRGs are helping already? And on peripheral, sales were flattish sequentially. Aetna is only 10% to 12% of covered lives, I believe. U.S. peripheral was a growth driver for you. So help us understand how Aetna has had so much of an impact? And I had one follow-up.

道格，首先在美國，美國的冠狀動脈在第四季加速。您認為新的 DRG 已經發揮了多大作用？在外圍設備方面，銷售額環比持平。我相信 Aetna 只佔受保人的 10% 到 12%。美國週邊國家是您的成長動力。那麼請幫助我們了解 Aetna 為何產生如此大的影響？我有一個後續行動。

Yes. Aetna was the phenomenon that was the real change that we noted after the sort of mid -- it really took place in September, so end of Q3. carried through into Q4. And when we first -- when we did our call last year, I don't know that we described the underlying sort of slowness of procedures that we were seeing in the third quarter into the fourth quarter for peripheral. So it would have been -- we would have been a little soft on peripheral, and then you compounded that with Aetna.

是的。 Aetna 是我們在中期之後注意到的真正變化的現象 - 它確實發生在 9 月份，所以是第三季末。延續到第四季。當我們去年第一次打電話時，我不知道我們是否描述了我們在第三季度到第四季度看到的外圍設備程序的潛在緩慢情況。所以，我們在外圍設備上會有點軟弱，然後你又與 Aetna 結合。

I'd say, on balance, peripheral procedures appear to be somewhat less soft, but it's -- so I think we feel more bullish about growth, particularly as we turn focus back to peripheral. Right now, we're -- for good reason, with 2 reimbursement changes, a new product launch, we really want to maximize on our coronary opportunity. And then when we have 3 product launches in a row in peripheral we'll be spending a lot of time on peripheral.

我想說，總的來說，外圍程序似乎不太軟，但它是 - 所以我認為我們對增長更加樂觀，特別是當我們將焦點重新轉向外圍時。現在，我們有充分的理由，透過兩次報銷變更、推出新產品，我們真的希望最大限度地利用我們的冠狀機會。然後，當我們在周邊方面連續推出 3 個產品時，我們將在外部設置上花費大量時間。

So we're anticipating peripheral will contribute much more nicely to growth end of '24 into '25, and high hopes for JAVELIN to be a major contributor to that end as well. So we're -- you're not wrong. Aetna is a 10% to 20% player on the -- in the matrix of all the private payers. So it wasn't just an Aetna phenomenon, but Aetna, clearly, was a meaningful -- had a meaningful impact, but it wasn't the entirety of the impact on the peripheral volume in the back end of last year.

因此，我們預計外圍設備將為 24 世紀末到 25 世紀的成長做出更大的貢獻，並且對 JAVELIN 也寄予厚望，成為這一目標的主要貢獻者。所以我們——你沒有錯。 Aetna 在所有私人付款人矩陣中只佔 10% 到 20%。因此，這不僅僅是 Aetna 現象，而且 Aetna 顯然是一種有意義的——產生了有意義的影響，但這並不是去年年底對外圍交易量的全部影響。

And Doug, sorry, the first part of the question was the acceleration in U.S. coronary. Was this -- the strength in the quarter came from U.S. coronary. Have you started to see an impact from the new DRGs already? And I'll ask my follow-up, Doug. There's a late breaker at ACC on Neovasc this ORBITA-COSMIC. How is it different from COSIRA-II? And is there any read-through from that trial to what we might see in COSIRA-II?

道格，抱歉，問題的第一部分是美國冠心病的加速發展。是這樣的嗎——本季的強勢來自美國冠狀動脈。您是否已經開始看到新 DRG 的影響？我會問我的跟進者，道格。在這個 ORBITA-COSMIC 的 Neovasc 上，ACC 有一個遲來的破壞者。它與 COSIRA-II 有什麼不同？從該試驗中我們可以看到 COSIRA-II 中的內容嗎？

It's really hard to -- well, generally, as we say consistently on reimbursement because it's what we've observed, it's a dimmer switch not an on and off switch, so it has an effect gradually over time. And we launched C2+ and we got the uplift simultaneously. It certainly doesn't -- it did not hurt at all. It will always be impossible to disaggregate new product launch and reimbursement that happened simultaneously, and it's now going to be even harder because now we've got the CPT goods.

這真的很難——嗯，一般來說，正如我們在報銷方面一貫所說的那樣，因為這是我們觀察到的，它是一個調光開關而不是開關，所以隨著時間的推移它會逐漸產生影響。我們推出了 C2+，同時也得到了提升。當然不會——一點也不痛。將同時發生的新產品發布和報銷分開始終是不可能的，而且現在變得更加困難，因為現在我們有了 CPT 商品。

Yes. I'll just pile on to that, Larry. What we talked about in the past, what the inpatient -- I think especially the inpatient uplift in the DRG, what it does ultimately is as the hospitals see the income coming in, it helps the cath lab budget get relaxed. And so the cath lab then puts less pressure on physicians to moderate their use.

是的。我會繼續說下去，拉里。我們過去談到的住院病人的情況——我認為特別是 DRG 中住院病人的增加，它最終的作用是當醫院看到收入進來時，它有助於放鬆導管實驗室預算。因此，導管實驗室對醫生限制其使用的壓力較小。

They can -- physicians then feel like they use IVL when it's appropriate and they're not getting pushback from cath lab administrators. And that takes time. I was at an account earlier this week in Santa Cruz, and that was the input from them. They just don't -- they're not getting push back from the administration anymore.

他們可以－醫生會覺得他們在適當的時候使用 IVL，並且不會受到導管實驗室管理員的反對。這需要時間。本週早些時候我去了聖克魯斯的一個帳戶，這是他們的意見。他們只是不這樣做——他們不再受到政府的壓制。

And on ORBITA-COSMIC, it's -- we certainly are delighted to see multiple data sets for Reducer at ACC. That's encouraging. We don't know the results from that study. It's small, 50-ish patients, so it's not going to be powered to make any conclusions about it. They use MRI as an endpoint, so really unclear if that's a -- I see that as a feasibility of that tool versus something that's going to be just positive about the Reducer.

在 ORBITA-COSMIC 上，我們當然很高興看到 ACC 上的多個Reducer 資料集。這令人鼓舞。我們不知道該研究的結果。它的規模很小，只有 50 名左右的患者，所以它沒有能力對此做出任何結論。他們使用 MRI 作為終點，所以真的不清楚這是否是一個——我認為這是該工具的可行性，而不是對減速器來說只是積極的東西。

I won't be surprised if you see that patients' symptoms are better because that's what we see consistently in the various studies that have been done on Reducer and what we see anecdotally from all the users in Europe. Whether you really learn anything, that is a read-through to COSIRA-II because we don't use MRI as an endpoint in COSIRA-II, so I don't know that that's going to really be informative on potential outcome of the COSIRA-II study. If the patients feel better in the treatment arm, that bodes well for COSIRA-II, I guess, could be the one takeaway.

如果您看到患者的症狀有所改善，我不會感到驚訝，因為這是我們在對Reducer 進行的各種研究中一致看到的情況，也是我們從歐洲所有用戶那裡看到的軼事。無論您是否真的學到了任何東西，這都是對 COSIRA-II 的通讀，因為我們不使用 MRI 作為 COSIRA-II 的終點，所以我不知道這是否真的會對 COSIRA 的潛在結果提供資訊-II研究。如果患者在治療組中感覺更好，我想這對 COSIRA-II 來說是個好兆頭，這可能是一個要點。

Our next question comes from the line of Michael Polark with Wolfe Research.

我們的下一個問題來自沃爾夫研究中心的邁克爾·波拉克（Michael Polark）。

I want to ask on the outpatient coronary reimbursement topic with an eye towards the map to 5194. Kind of 2-parter. The event path from here, and then a question on coding. So is this event path simply we wake up in July, we see the proposal and we see what we see? Or do you have an opportunity to engage with CMS here through this spring that might give you a better feel for how they're looking at this?

我想詢問門診冠狀動脈報銷的話題，著眼於 5194 的地圖。有點像 2 方。事件路徑從這裡開始，然後是一個關於編碼的問題。那麼這個事件路徑只是我們在七月醒來，我們看到提案並看到我們所看到的嗎？或者今年春天您是否有機會與 CMS 合作，這可能會讓您更了解他們如何看待這個問題？

And the second piece is on coding. I think we're operating under the assumption that this winds up getting solved with the complexity adjustment using the new CPT code that was in effect Jan 1, '24. Is that correct? Or is there potentially another to-be-determined coating solution here?

第二部分是關於編碼。我認為我們的運作假設是，這個問題最終可以透過使用 24 年 1 月 1 日生效的新 CPT 程式碼進行複雜性調整來解決。那是對的嗎？或者這裡是否還有另一種有待確定的塗層解決方案？

It would be a waste if I try to answer this one. Rob's sitting right next to me, so I'll let Rob take this one.

如果我嘗試回答這個問題那就太浪費了。羅布坐在我旁邊，所以我請羅布拿這個。

Yes. I think the -- so as part of normal course of business, we do get on CMS' calendar as they start to make -- they get into their rule-making cycle. And so certainly, we have met with CMS, again, about this issue and the issue of the transitional pass-through and so on and so forth. So I think your first question was what's the normal course of business and the sort of things that happen.

是的。我認為，作為正常業務流程的一部分，當他們開始製定規則時，我們確實會進入 CMS 的日曆，他們會進入規則制定週期。當然，我們再次與 CMS 會面，討論這個問題以及過渡傳遞等問題。所以我認為你的第一個問題是正常的業務流程是什麼以及會發生哪些事情。

And the first thing that happens is that you sort of talk with CMS prior to them making the rule, drafting the rule, about your issue at hand. And so that's happened. I think the things that we see from here, yes, I would mainly point the next sort of public available information is likely going to be the proposed rule, which happens in early July. So we won't sort of see or hear much in the public domain between now and then. So hopefully, Mike, that got that part of the question.

首先發生的事情是，在 CMS 制定規則、起草規則之前，您先與 CMS 討論您手邊的問題。事情就這樣發生了。我認為我們從這裡看到的事情，是的，我主要指出下一種公開可用資訊可能是擬議的規則，該規則將於 7 月初發生。因此，從現在到那時，我們不會在公共領域看到或聽到太多。希望麥克能解答這部分問題。

I think your second part of the question, or your second question, was just around the mechanism that would proceed here. And I think you've identified it correctly that here, what we're talking about as a complexity adjustment that's based on an add-on code, a procedure add-on code, and that's the normal vehicle by which if you have an add-on code in structure, that's how you get increased payment, is then you then sort of qualify -- certain combinations of code qualify for complexity adjustment, and that's exactly sort of what we're looking at here.

我認為你問題的第二部分，或是你的第二個問題，只是圍繞著這裡將要進行的機制。我認為您已經正確地識別了這一點，我們在這裡談論的是基於附加代碼、過程附加代碼的複雜性調整，如果您有附加代碼，那麼這是正常的工具- 在結構上的代碼上，這就是您獲得增加付款的方式，然後您就符合資格- 代碼的某些組合符合複雜性調整的資格，而這正是我們在這裡所看到的。

And as (inaudible) on this call and others, this is where we have a very large volume of data associated with that. We have sort of strong confidence in these combinations of codes and then qualifying for complexity adjustment.

就像本次電話會議和其他電話會議（聽不清楚）一樣，我們擁有大量與之相關的數據。我們對這些程式碼組合以及複雜性調整的資格有很強的信心。

That was a great, Rob, on both fronts. And the brief follow-up is maybe back to Doug. I think, Doug, on several instances, you've suggested maybe 95% confidence in the outcome here of kind of achieving 5194 in 2025 and beyond. Is 95% still how you feel about this?

羅布，這在兩個方面都是偉大的。簡短的後續行動可能會回到道格。道格，我認為，在某些情況下，您表示對 2025 年及以後實現 5194 的結果有 95% 的信心。 95%的人仍然這麼認為嗎？

I do not feel less confident. I wish CMS, when Rob met with them, said, you're right, we're going to do it. But they don't say those things. They just look blankly at Rob. And every time we meet, and usually, we get a good outcome. And this time, I think the facts are pretty clearly pointing in the direction of moving to 5194.

我並沒有感到信心不足。我希望 CMS 在 Rob 與他們見面時說，你是對的，我們會這麼做。但他們不說那些話。他們只是茫然地看著羅布。每次我們見面，通常都會得到好的結果。這一次，我認為事實非常清楚地指向了轉向 5194 的方向。

Our next question comes from the line of Mike Kratky with Leerink Partners.

我們的下一個問題來自 Leerink Partners 的 Mike Kratky。

You called out 2% penetration in Germany. Can you just give us a sense of where you are in terms of penetration within key accounts? And what have you seen in terms of how utilization has scaled early on, and what procedure volumes look like in some of the top accounts?

您聲稱德國的滲透率為 2%。您能否讓我們了解一下您在大客戶中的滲透率？您在早期使用率如何擴展方面看到了什麼，以及一些頂級帳戶中的程式量是什麼樣的？

Sure. We have -- I think even in the top accounts in Germany, the penetration is still relatively low. What happens in Germany when there isn't sufficient payment to cover the cost of a product, there's a very tight linkage between the hospital administration and the physician's behavior in Germany, tighter than I think anywhere else except Japan. The -- so what happens is the physicians will use the product until the administration tells them to stop and then they stop.

當然。我認為即使在德國的頂級帳戶中，滲透率仍然相對較低。當沒有足夠的付款來支付產品成本時，在德國會發生什麼，德國的醫院管理和醫生的行為之間存在非常緊密的聯繫，比我想像的除日本以外的其他任何地方都要緊密。 - 所以發生的情況是，醫生會使用該產品，直到政府告訴他們停止，然後他們就停止使用。

So you'd get the cyclical -- an account using the product, and then it would just turn off in September. Or they'd use the product and then the administration will come back the next year and say, "Hey, you use [50], you only get [25] this year." And so the product utilization will get curtailed. And then at smaller accounts, it would essentially be zero because they just didn't have enough money within the hospital system to cover these extra costs and the administration would clamp down.

所以你會得到一個週期性的——一個使用該產品的帳戶，然後它就會在九月關閉。或者他們會使用該產品，然後政府會在明年回來說：“嘿，你使用 [50]，今年你只能得到 [25]。”因此產品的利用率將會受到限制。然後，對於較小的帳戶，它基本上為零，因為他們只是在醫院系統內沒有足夠的資金來支付這些額外費用，而政府將予以壓制。

So we really have a lot of headroom in Germany, not just gaining adoption in smaller accounts, which is kind of a zero base in those accounts but then really driving appropriate use and adoption at the larger accounts where it was being curtailed by the administration. Does that answer your question?

因此，我們在德國確實有很大的發展空間，不僅在較小的帳戶中獲得採用，這在這些帳戶中是零基數，而且在政府限制的較大帳戶中真正推動了適當的使用和採用。這是否回答你的問題？

Yes, it's perfect. I mean just one separate follow-up. It looks like on COSIRA-II, the CT.gov is giving you a primary completion date of June 2024, but I just wanted to double check on how we should think about the timing there and when we could see those results.

是的，它很完美。我的意思是只有一個單獨的後續行動。在 COSIRA-II 上，CT.gov 給出的主要完成日期是 2024 年 6 月，但我只是想仔細檢查我們應該如何考慮該時間表以及何時可以看到這些結果。

Yes, we need to update that.

是的，我們需要更新它。

I don't think we've touched that since the acquisition, so that was not a realistic time line ever.

我認為自收購以來我們還沒有觸及過這個問題，所以這不是一個現實的時間表。

Yes. That was the prior company's time line. Yes. Right now, if you recall, we're forecasting approval in '27. You got to back up from there for submission and review of a PMA, and then that puts your enrollment completion somewhere second half of '25 is a much more realistic time line. And the team is doing a really exceptional job of getting sites up. There was a paucity of sites that had been started, and many of those sites weren't really probably the right sites to choose to get rapid enrollment.

是的。這是前一家公司的時間表。是的。現在，如果您還記得的話，我們預計將在 27 年獲得批准。您必須從那裡備份並提交 PMA 並進行審核，然後您的註冊完成時間將在 25 年下半年，這是一個更現實的時間表。該團隊在網站建立方面做得非常出色。已經啟動的網站很少，而且其中許多網站可能不是真正適合選擇快速註冊的網站。

So our team, once they took over, have gotten the trial on the rails, but it's a sham-controlled trial with a really rigorous enrollment criteria, inclusion criteria, which is why every time we show clinicians the trial design, they universally say if, and we would say when, when that study is successful, it's -- it will be irrefutable that, that device works. So rigorous trial makes it hard to enroll. A rigorous trial also results in much more valuable data for market creation and -- inclusive of reimbursement.

因此，我們的團隊一旦接手，就已經讓試驗步入正軌，但這是一項假對照試驗，具有非常嚴格的入組標準、納入標準，這就是為什麼每次我們向臨床醫生展示試驗設計時，他們都普遍說如果，我們會說，當該研究成功時，該設備將發揮作用，這是無可辯駁的。如此嚴格的篩選，導致入學困難重重。嚴格的試驗還可以為市場創建和報銷提供更有價值的數據。

Our next question comes from the line of 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 new peripheral products, so E8 and JAVELIN. I can't remember if you had said anything about the pricing on those products at the Investor Day you did in the fall, but can you give us any sense there on where those things would be priced?

僅介紹一些新的外圍產品，例如 E8 和 JAVELIN。我不記得您在秋季的投資者日上是否說過有關這些產品定價的任何信息，但您能否告訴我們這些產品的定價？

And then with JAVELIN, I mean, am I thinking about it the right way that, that's something that could drive more revenue per procedure, because they would likely use that to kind of cross a lesion and then you follow that up with one of the regular catheter -- or sorry, balloons?

然後對於標槍，我的意思是，我是否以正確的方式思考它，這可以為每個程序帶來更多收入，因為他們可能會用它來跨越病變，然後你用其中之一來跟進普通導管——或者抱歉，氣球？

We -- if we said anything about price, it would have been something along the lines of we will determine the price when we get closer to launching the product, and that would still be what I would say now. Thus far, we try to make sure that we deliver really clinically meaningful new devices to our customers and price them in a way that we think is -- enables the customers to have a good financial outcome and for us to reflect the value of the technology.

我們——如果我們說任何關於價格的事情，那就是我們將在接近推出產品時確定價格，這仍然是我現在要說的。到目前為止，我們努力確保向客戶提供真正具有臨床意義的新設備，並以我們認為的方式定價——使客戶能夠獲得良好的財務成果，並使我們能夠體現技術的價值。

In terms of JAVELIN, there likely will be some cases where you use JAVELIN plus, JAVELIN plus E8, JAVELIN plus M5+, but we -- what we've witnessed thus far is that the power of the lithotripsy shock waves is not just cracking in a sort of forward effect to get you through the difficult to cross lesions, but it also has a radial effect, which enables you to then follow JAVELIN with standard balloon angioplasty.

就 JAVELIN 而言，在某些情況下您可能會使用 JAVELIN plus、JAVELIN plus E8、JAVELIN plus M5+，但我們 - 迄今為止我們所目睹的是，碎石沖擊波的力量不僅僅是破解一種向前效應，可以幫助您穿過難以穿越的病變，但它也具有徑向效應，使您能夠跟隨JAVELIN 進行標準球囊血管成形術。

And so our expectation is that the vast majority of cases will be JAVELIN plus POBA versus JAVELIN plus another IVL product. At some juncture, you start to get yourself in a challenging situation with your customers if you load too many IVL products into a single procedure. It just becomes less economically attractive for them. So we're -- our expectation is that, for the most part, JAVELIN is going to be a JAVELIN plus other, JAVELIN plus balloon.

因此，我們的預期是，絕大多數病例將是 JAVELIN 加 POBA，而不是 JAVELIN 加另一種 IVL 產品。在某些時候，如果您將太多 IVL 產品加載到單一程式中，您就會開始讓自己與客戶陷入困境。它對他們來說在經濟上的吸引力變得越來越小。所以我們——我們的期望是，在很大程度上，標槍將是標槍加其他、標槍加氣球。

That makes sense. And then just as far as Costa Rica goes, I understand that there's some kind of start-up costs and whatnot in the near term, but is that something that you expect to have a material benefit to your gross margins over time?

這就說得通了。就哥斯達黎加而言，我知道短期內會有某種啟動成本等等，但您希望隨著時間的推移，這會對您的毛利率產生實質的好處嗎？

We have chosen to date to manufacture in one of the highest cost places in America, in Santa Clara. So we do expect that our cost of goods will come down in Costa Rica. So we've not forecast how many points will pick up out of Costa Rica, but cost of doing business there in every respect is going to be lower than -- other than materials cost, is going to be lower in every respect than what we have right now in Santa Clara.

迄今為止，我們選擇在美國成本最高的地方之一聖克拉拉進行製造。因此，我們確實預期哥斯達黎加的商品成本將會下降。因此，我們還沒有預測哥斯達黎加會上升多少分，但在那裡開展業務的各方面成本都將低於——除了材料成本之外，在各方面都將低於我們的水平。現在在聖克拉拉。

Just important to remember, though, that for 2024, the product we sell will be manufactured in Santa Clara, so we won't see any benefit to gross margin in 2024.

但重要的是要記住，到 2024 年，我們銷售的產品將在聖克拉拉製造，因此我們不會看到 2024 年毛利率有任何好處。

Yes. We'll put product into inventory this year, but it won't hit customers until '25.

是的。我們今年會將產品放入庫存，但要到 25 年才會上市。

Yes, I understand. So there'll definitely be a benefit yet to be quantified, I guess, for '25 and beyond.

是的我明白。因此，我想，25 年及以後肯定會有尚未量化的好處。

Do you agree?

你同意？

Correct. Yes. I would certainly expect gross margins to be steady for this year. And then in the long run, we will see an improvement given the structure set up.

正確的。是的。我當然預計今年的毛利率將保持穩定。從長遠來看，我們會看到所建立的結構有所改善。

Our next question comes from the line of 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（Imron Zafar）。

First, on Japan, I'm wondering if you can just sort of give us any sort of metrics on where you are in that launch in terms of what percentage of the 1,200 or so cath labs there that you're in now at this stage of the launch?

首先，關於日本，我想知道您是否可以向我們提供有關您在該啟動中所處位置的任何指標，即您在該階段目前所在的 1,200 多個導管實驗室中所佔的百分比發射的？

Sure. So the -- again, very, very good year for the team in Japan. It's a relatively small team, and they were incredibly productive in 2023. Based on the guidelines that we worked with, that Shockwave worked with CVIT, the cardiovascular society in Japan, to establish, we are currently limited to hospitals that do a certain number of atherectomy procedures. So those tend to be larger hospitals, obviously, with surgical backup.

當然。所以對日本隊來說，這又是非常非常好的一年。這是一個相對較小的團隊，但他們在 2023 年的生產力非常高。根據我們與 Shockwave 與日本心血管協會 CVIT 合作制定的指導方針，我們目前僅限於進行一定數量的手術的醫院斑塊旋切手術。顯然，這些醫院往往是較大的醫院，有手術支援。

There's also some limitations on, because of the way the trial data we have, we don't have trial data of Shockwave followed by de novo DCB, and de novo DCB is approved in Japan. We don't have trial data of Shockwave after atherectomy, Rota-Shock, for instance. So part of the work we're doing, it started last year and we'll be going on in earnest this year and the following years, is to create clinical data to support the use of Shockwave with de novo DCB, to support the use of Rota-Shock, Shockwave with atherectomy.

還有一些限制，由於我們掌握的試驗數據方式，我們沒有 Shockwave 和 de novo DCB 的試驗數據，而 de novo DCB 在日本獲得批准。例如，我們沒有旋切術後衝擊波（Rota-Shock）的試驗數據。因此，我們去年開始做的部分工作，今年和接下來的幾年我們將認真進行，就是創建臨床數據來支持 Shockwave 與 de novo DCB 的使用，支持使用Rota-Shock、衝擊波與旋切術。

And then as we gather more and more data, work with CVIT to show that the product can be safely used in smaller centers, in centers without surgical backup. And as you'll recall, we have that kind of stamp of approval in the U.S. from SCAI already. So there is -- there's basically a certain number of centers that we have agreed with CVIT that we cannot access until we generate more data, and we're generating those data now. So with the centers that we really can access, which account for probably 75% of the PCI in Japan, we're over 50% launched. Or sorry, we've launched over 50% of those centers, and we'll launch the remaining ones in 2024.

然後，隨著我們收集越來越多的數據，與 CVIT 合作，證明該產品可以在較小的中心、沒有手術支援的中心安全使用。您可能還記得，我們​​已經在美國獲得了 SCAI 的批准印章。因此，我們已經與 CVIT 達成一致，基本上有一定數量的中心，在我們產生更多數據之前我們無法存取這些中心，而我們現在正在產生這些數據。因此，對於我們真正可以訪問的中心（可能佔日本 PCI 的 75%），我們已經啟動了超過 50% 的中心。或者抱歉，我們已經推出了超過 50% 的中心，我們將在 2024 年推出剩餘的中心。

Okay. And what about the peripheral IVL side in Japan? What's the latest time line there?

好的。那麼日本週邊的IVL方面又如何呢？那裡最晚的時間是多少？

We haven't disclosed the time line yet. We're working right now with the PMDA to establish the regulatory path, and then once that's done kind of first half of this year, we hope to have the path established, then we'll start lining out the timing and the -- or the steps and the timing to get there. And at some point, we'll tell you what that is.

我們還沒有透露時間表。我們現在正在與 PMDA 合作建立監管路徑，然後一旦在今年上半年完成，我們希望建立路徑，然後我們將開始製定時間表和——或者到達那裡的步驟和時間。在某個時候，我們會告訴你那是什麼。

Okay. And then one more international question on India. Obviously, a massive PCI market. Can you just remind us where you are there at this stage and how you're thinking about that opportunity over the next few years?

好的。然後還有一個關於印度的國際問題。顯然，PCI 市場龐大。您能否提醒我們您目前所處的階段以及您如何看待未來幾年的機會？

Sure. We have a distributor in India. We established the distributor in 2020. We launched coincident with coronavirus in February 2020, so the -- as that country has kind of gone through some ups and downs like the rest of the world, we've gotten a good footprint in India through a distributor. We've generated really nice post-market data in India, post-market registry over 1,000 patients, all comers, core lab adjudicated. Those were presented at -- those data were presented at TCT last fall, and we continue to have really nice momentum, particularly on coronary in India.

當然。我們在印度有經銷商。我們於 2020 年建立了經銷商。我們於 2020 年 2 月推出了與冠狀病毒同時進行的產品，因此，由於該國像世界其他地方一樣經歷了一些起伏，我們透過經銷商。我們在印度產生了非常好的上市後數據，上市後登記了超過 1,000 名患者，所有患者都是來者，並由核心實驗室裁定。這些數據是在去年秋天的 TCT 上公佈的，我們仍然擁有非常好的勢頭，特別是在印度的冠狀動脈方面。

Okay. And then just one very quick pipeline question. Have you guys started human cases with the aortic lithotripsy product yet?

好的。然後就是一個非常快速的管道問題。你們已經開始使用主動脈碎石產品進行人體案例了嗎？

We have not. No.

我們還沒有。不。

Any estimated timeline on that?

有大概的時間表嗎？

This year.

今年。

Our next question comes from the line of Danielle Antalffy.

我們的下一個問題來自 Danielle Antalffy。

Doug, I was going to ask about C2+. How are you seeing that being adopted? I know it's early days. You said feedback has been good, but are you seeing it motivate more physicians to pick up IVL and do vessel prep in their patients? Or is it right now more about existing users, treating more patients and accessing those tougher to treat patients?

道格，我想問有關 C2+ 的問題。您如何看待它被採用？我知道現在還為時過早。您說回饋很好，但是您是否看到它會激勵更多的醫生接受 IVL 並為患者進行血管準備？或者現在更多的是現有使用者、治療更多患者、接觸那些更難治療的患者？

Yes, I'd say it's more adoption existing users versus new users. And that's -- and more adoption is going to be the -- with all of the different tailwinds we have, reimbursement and technology tailwinds followed by another technology upgrade next year, it's really finding ways to help people who use -- shift from 4% to 10% and from 10% to 20%, helping give them a good reason to use Shockwave more than they already do. Those who don't use the device yet are in the minority and less of a -- sort of much less opportunity for us to drive growth with, because they're probably also pretty low volume operators.

是的，我想說的是，與新用戶相比，現有用戶的採用率更高。這就是——而且將會有更多的採用——隨著我們擁有的所有不同的推動因素，報銷和技術推動因素以及明年的另一次技術升級，它確實在尋找方法來幫助使用的人從4 % 轉變為 10% 以及從 10% 到 20%，這為他們提供了比現在更多地使用 Shockwave 的充分理由。那些尚未使用該設備的人只是少數，而且我們推動成長的機會也更少，因為他們可能也是產量相當低的營運商。

And that was kind of my -- one of my follow-up questions. You already touched on it, on existing users who both do IVL and (inaudible) that there is a large number of patients (inaudible) treating all of them (inaudible). Why are they...

這是我的後續問題之一。您已經談到了現有的 IVL 使用者（聽不清楚），並且有大量患者（聽不清楚）正在治療他們所有人（聽不清楚）。為什麼他們...

So your phone made it tricky to interpret your question, but I'm going to -- I'll restate your question as best I can, and you tell me if I'm wrong. So what is the impediment to increase use of IVL or physicians?

所以你的手機讓解釋你的問題變得很棘手，但我會——我會盡我所能重述你的問題，你告訴我我是否錯了。那麼增加 IVL 或醫師使用的障礙是什麼？

Sorry about that.

對於那個很抱歉。

No, that's okay. It's, it just makes it a little more challenging. So the biggest reason historically has been, a, is the economic concern. We have a premium device that we priced at a level that we thought both reflected the value and would ultimately lead to a strong reimbursement position that would be beneficial to the hospital. Thankfully, the work Rob and team did was successful. We were successful in securing our own DRGs, which were shocking, on the coronary side, CPT code, and we think ultimately will also yield sort of landing in the highest APC level for coronaries.

不，沒關係。它只是讓它變得更具挑戰性。因此，歷史上最大的原因是，a，是經濟關切。我們擁有一款優質設備，我們的定價水平我們認為既反映了價值，又最終帶來了強大的報銷地位，這對醫院有利。值得慶幸的是，Rob 和團隊所做的工作非常成功。我們成功地確保了我們自己的 DRG，在冠狀動脈方面，CPT 代碼令人震驚，我們認為最終也將實現冠狀動脈最高 APC 水平的著陸。

So -- but the initial reaction to the price was, oh, this is a high-priced device, and there was a lot of anxiety with TPT. That's a little unusual in terms of a reimbursement mechanism, and so there's always been a perception amongst physicians that we're not really reimbursed even though we have been. So there's always been a reluctance in many physicians' hands and minds to -- like I'll only use Shockwave when I absolutely have to because it's an expensive device.

所以 - 但對價格的最初反應是，哦，這是一個高價設備，並且對 TPT 有很多焦慮。就報銷機製而言，這有點不尋常，因此醫生們一直認為我們並沒有真正得到報銷，儘管我們已經報銷了。因此，許多醫生的手和頭腦總是不願意——就像我只會在絕對必要時使用衝擊波，因為它是一種昂貴的設備。

So now that the first 2 of the 3 building blocks for eliminating that economic anxiety with the DRGs and CPT code are in place, we think this year will be the first year where a lot of that economic anxiety is ameliorated. The second, another reason why they have been reluctant historically is I've got this long diffuse lesion. You're going to -- I'm going to have to pull 2 catheters to treat it. Maybe I'll just use atherectomy instead of Shockwave. C2+ addresses that long diffuse reluctance. It also helps diffuse the sort of misperception that Shockwave is less effective on eccentric or nodular calcium.

因此，既然 DRG 和 CPT 代碼消除經濟焦慮的 3 個構建模組中的前 2 個已經到位，我們認為今年將是經濟焦慮得到很大程度緩解的第一年。第二個，也是他們歷史上一直不情願的另一個原因是我有這麼長的瀰漫性病變。你將--我將不得不拔出兩根導管來治療它。也許我會使用旋切術而不是衝擊波。 C2+ 解決了長期以來普遍存在的不情願問題。它還有助於消除衝擊波對偏心或結節鈣效果較差的誤解。

So now we give you more power, you can treat those eccentric lesions with 1 catheter. So those are really 2 of the big headwinds we had faced, the biggest being the economics. And then ultimately, the -- I think the last -- one of the sort of next hurdles that we'll knock down is the our device is very deliverable, but it's not as deliverable as physicians would like.

所以現在我們給你更多的力量，你可以用導管治療那些偏心的病變。因此，這確實是我們面臨的兩大阻力，其中最大的是經濟因素。最終，我認為是最後一個，我們要克服的下一個障礙之一是我們的設備非常可交付，但它並不像醫生希望的那樣可交付。

So there are times when they choose not to pull it because it's bulkier than a regular angioplasty balloon. So I'll just use something else. That's a 2025 fix that we'll have with [Arrow]. So we've got -- each year, we'll be knocking down the remaining -- some of the remaining pressure points that have capped utilization, and we think we'll just keep uncapping utilization each year.

因此，有時他們選擇不拉動它，因為它比普通的血管成形術球囊笨重。所以我就用別的東西吧。這是我們將在 2025 年透過 [Arrow] 進行的修復。因此，我們每年都會消除剩餘的一些限制利用率的壓力點，我們認為我們每年都會繼續取消利用率上限。

There are no further questions in the queue. I'd like to hand it back to Doug Godshall for closing remarks.

隊列中沒有其他問題。我想把它交還給 Doug Godshall 作結束語。

Thanks so much, and thanks, everybody, for your time and attention. Looking forward to another great year in 2024, and delighted to have Renee on board. Look forward to chatting with you all as the year progresses.

非常感謝，也感謝大家的時間和關注。期待 2024 年又一個美好的一年，很高興 Renee 加入。隨著這一年的進展，期待與大家聊天。

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.

女士們、先生們，今天的電話會議到此結束。感謝您的參與。此時您可以斷開線路，度過美好的一天。