Shockwave Medical Inc (SWAV) 2021 Q4 法說會逐字稿

Good afternoon, and welcome to the ShockWave's Fourth Quarter and Year-end 2021 Earnings Conference Call. (Operator Instructions)

下午好，歡迎參加 ShockWave 2021 年第四季度和年終收益電話會議。 （操作員說明）

As a reminder, this call is being recorded for replay purposes.

謹此提醒，本次通話將被錄音以供重播。

I would now like to turn the call over to Debbie Kaster, Vice President of Investor Relations at ShockWave, for a few introductory comments.

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, Chief Commercial Officer; and Dan Puckett, Chief Financial Officer.

感謝大家參加今天的電話會議。今天與我一起參加 ShockWave Medical 的是總裁兼首席執行官 Doug Godshall；艾薩克·扎卡里亞斯 (Isaac Zacharias)，首席商務官；和首席財務官 Dan Puckett。

Earlier today, ShockWave released financial results for the quarter and year ended December 31, 2021. A copy of the press release is available on ShockWave's website.

今天早些時候，ShockWave 發布了截至 2021 年 12 月 31 日的季度和年度財務業績。該新聞稿的副本可在 ShockWave 的網站上獲取。

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.

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。

Any statements contained in this call that relate to the expectations or predictions of future events, results or performance 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 and future product development and approvals are based upon our current estimates of various assumptions. These statements involve material risks and uncertainties, including the impact of the COVID-19 pandemic, that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

本次電話會議中包含的任何與未來事件、結果或業績的預期或預測相關的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、財務和收入預期以及未來產品開發和批准有關的陳述，均基於我們當前對各種假設的估計。這些陳述涉及重大風險和不確定性，包括 COVID-19 大流行的影響，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存在重大差異。

Accordingly, you should not place any 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.

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。

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 17, 2022.

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（2022 年 2 月 17 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 fourth quarter and full year of 2021.

謝謝，黛比。大家下午好，感謝您抽出時間與我們一起回顧 ShockWave 2021 年第四季度和全年的業績。

The past year has been full of ups and downs for all of us, but the ShockWave team has persisted through the many challenges as we continue to pursue our mission to improve outcomes for patients with calcified vascular disease.

過去的一年對我們所有人來說都是風風雨雨，但 ShockWave 團隊堅持克服了許多挑戰，繼續追求改善鈣化血管疾病患者治療結果的使命。

We achieved quarterly revenue of $84.2 million in the fourth quarter of 2021, which was 271% above the fourth quarter of 2020, and annual revenue of $237.1 million in 2021, an increase of 250% above the full year 2020.

我們在 2021 年第四季度實現了 8420 萬美元的季度收入，比 2020 年第四季度增長了 271%，2021 年的年度收入為 2.371 億美元，比 2020 年全年增長了 250%。

Our strong global growth confirms how significant the clinical need has been for a better calcium treatment and how well our team is hitting the mark with IVL. Despite the ongoing impact of COVID, as Delta transitioned into Omicron, our business and our team continued to outperform our expectations. Isaac will touch on more specifics in a moment, but at a high level, while coronary led the quarter once again, we also saw a nice uptick from the third quarter in both our international business and our U.S. peripheral franchises.

我們強勁的全球增長證實了臨床對更好的鈣治療的需求有多麼重要，以及我們的團隊在 IVL 方面取得了多大的成功。儘管新冠疫情的影響持續存在，但隨著達美航空轉型為 Omicron，我們的業務和團隊的表現仍然超出了我們的預期。艾薩克稍後將談到更多細節，但在高水平上，雖然冠狀病毒再次領先本季度，但我們也看到我們的國際業務和美國周邊特許經營權較第三季度有了良好的增長。

2022 is shaping up to be another strong year for the company with 3 main drivers: continued coronary growth as we add new accounts and better penetrate existing accounts; accelerated peripheral growth due to the combination of the upcoming launch of the -- our M5 catheter and the improved peripheral reimbursement for our above-the-knee codes and continued strengthening of our international business, led by a full year's benefit of the transition from distributor to direct sales in France and the U.K.

2022 年將是該公司又一個強勁的一年，有 3 個主要驅動力：隨著我們增加新客戶並更好地滲透現有客戶，實現持續的冠狀增長；由於我們即將推出的 M5 導管和我們膝上代碼的外周補償的改善以及我們國際業務的持續加強（由分銷商轉型帶來的全年收益帶動），外周業務的增長加速在法國和英國直接銷售

While Omicron will be a downdraft on the first quarter for ShockWave and most of med tech, we have high hopes for the post first quarter recovery, and as a result, we expect our full year 2022 revenue to fall in the range of $405 million to $425 million, representing growth of 71% to 79% from 2021.

雖然 Omicron 將在第一季度對 ShockWave 和大多數醫療技術造成影響，但我們對第一季度後的複蘇寄予厚望，因此，我們預計 2022 年全年收入將下降到 4.05 億美元至 4.05 億美元之間。 4.25 億美元，較 2021 年增長 71% 至 79%。

To provide more color on the commercial front, I will now turn the call over to Isaac. Then Dan and I will share more detail on the broader business and financial results.

為了在商業方面提供更多的色彩，我現在將把電話轉給艾薩克。然後丹和我將分享有關更廣泛的業務和財務業績的更多細節。

Thank you, Doug.

謝謝你，道格。

Despite the increased number of COVID cases in the latter part of Q4, our team put up great numbers to finish out 2021. U.S. coronary sales continue to be strong as we near the anniversary of that launch. Further, our U.S. peripheral and our international businesses reported strong sequential and year-on-year growth. With these solid numbers, it is hard for us to parse out the specific impact that COVID had on our Q4 business. That said, we did start to see an increasing number of restrictions on elective procedures and staffing issues as we exited the year. This has continued in Q1 with staffing shortages causing postponement of cases even when elective procedures are not being restricted by the hospital.

儘管第四季度下半年新冠肺炎病例數量有所增加，但我們的團隊在 2021 年結束時仍取得了巨大的成績。隨著上市週年紀念日的臨近，美國冠狀動脈的銷售仍然強勁。此外，我們的美國周邊地區和國際業務呈現強勁的環比和同比增長。有了這些可靠的數字，我們很難分析出新冠疫情對我們第四季度業務的具體影響。也就是說，隨著今年的結束，我們確實開始看到對選舉程序和人員配置問題的限制越來越多。這種情況在第一季度持續存在，人員短缺導致病例推遲，即使醫院沒有限制擇期手術。

On balance, the situation seems to be getting better globally as Q1 progresses. In the absence of a new strain or some unforeseen situation, we remain cautiously optimistic that there will not be significant COVID-related disruptions to our business for the balance of 2022.

總的來說，隨著第一季度的進展，全球形勢似乎正在好轉。在沒有出現新的壓力或出現一些不可預見的情況的情況下，我們仍然謹慎樂觀地認為，在 2022 年剩餘時間裡，我們的業務不會受到與新冠病毒相關的重大干擾。

We continue to be pleased with the performance of our U.S. sales team and their ability to service customers effectively with the peripheral and coronary products in one bag. As expected, more accounts are using both coronary and peripheral as customers increasingly adopt IVL for the variety of indications.

我們仍然對美國銷售團隊的表現以及他們通過一袋外周產品和冠狀動脈產品有效服務客戶的能力感到滿意。正如預期的那樣，隨著客戶越來越多地採用 IVL 來治療各種適應症，越來越多的客戶同時使用冠狀動脈和外周血管。

In the fourth quarter, 58% of our U.S. accounts purchased both coronary and peripheral products, 20% purchased only coronary and 22% purchased only peripheral. Our goal remains to eventually have all of our customers using both coronary and peripheral IVL.

第四季度，我們 58% 的美國賬戶同時購買了冠狀動脈和外周產品，20% 的賬戶僅購買了冠狀動脈，22% 的賬戶僅購買了外周產品。我們的目標仍然是最終讓所有客戶同時使用冠狀動脈和外周 IVL。

Dialing in on some of the U.S. coronary metrics from the fourth quarter, C2 reorders represented 83% of the quarterly revenue, continuing the solid trend we have seen throughout the year. And we expect this to keep growing as the number of new accounts decreases throughout the year. While U.S. coronary growth was driven by launched accounts, new account openings were strong in Q4 as we added an average of 1 new coronary count per territory per month. This number has trended downward as expected as we continue to steadily penetrate the total account base and selectively add new territories.

根據第四季度的一些美國冠狀動脈指標，C2 再訂購量佔季度收入的 83%，延續了我們全年看到的穩健趨勢。我們預計，隨著全年新賬戶數量的減少，這一數字將繼續增長。雖然美國冠狀病毒的增長是由新開戶賬戶推動的，但第四季度新開戶數量強勁，因為我們每個地區每月平均增加 1 例新冠狀病毒計數。隨著我們繼續穩步滲透總客戶群並有選擇地添加新區域，這一數字已按預期呈下降趨勢。

We will continue adding accounts throughout 2022, while at the same time, increasing C2 use within our existing customer base. Our initial order quantity continues to average 5 units per new account, and we don't expect this to change for the accounts that will launch this year.

我們將在 2022 年繼續增加賬戶，同時增加現有客戶群中 C2 的使用。我們的初始訂單數量仍然是每個新帳戶平均 5 件，我們預計今年推出的帳戶不會發生變化。

The team delivered solid growth in the peripheral products in the quarter. As you are aware, this is a hospital-based business for us, and the solid performance in the quarter is a reasonable indicator that despite the challenges our customers have with COVID and staffing, they will see the value in treating heavily calcified lesions with IVL.

該團隊在本季度的外圍產品方面實現了穩健增長。如您所知，這對我們來說是一項以醫院為基礎的業務，本季度的穩健業績是一個合理的指標，表明儘管我們的客戶在新冠肺炎和人員配備方面面臨挑戰，但他們將看到使用 IVL 治療嚴重鈣化病變的價值。

In the fourth quarter, nearly half of our U.S. territory managers sold more than $1 million of IVL products. This is a testament to their ability to deliver on both the coronary and peripheral side of the business. We don't have a target number for how large a territory should be in terms of sales, but we are pleased with the growth we have seen and expect this will continue to grow.

第四季度，我們近一半的美國地區經理銷售了超過 100 萬美元的 IVL 產品。這證明了他們在業務的核心和外圍方面提供服務的能力。我們沒有關於銷售區域應有多大的目標數字，但我們對所看到的增長感到滿意，並預計這種增長將繼續增長。

Turning to the international business, where we are selling products in almost 60 countries, we saw healthy sales growth as the team finished the year strong. Our international team expanded from 19 to 40 people in 2021 as we continue to add to our sales and marketing teams. We now have employees based in 11 countries, including Japan, India and across Europe. The global presence of ShockWave employees helps us stay close to our customers and make sure we are able -- we are being responsive to their feedback and needs. The team also works closely with our distribution partners, and we are pleased with that side of the business.

談到國際業務，我們在近 60 個國家/地區銷售產品，隨著團隊在這一年的強勁表現，我們看到了健康的銷售增長。隨著我們不斷擴大銷售和營銷團隊，我們的國際團隊人數在 2021 年從 19 人擴大到 40 人。目前，我們的員工遍布 11 個國家/地區，包括日本、印度和整個歐洲。 ShockWave 員工遍布全球，幫助我們與客戶保持密切聯繫，並確保我們能夠響應他們的反饋和需求。該團隊還與我們的分銷合作夥伴密切合作，我們對這方面的業務感到滿意。

Q4 was the first full quarter of direct sales in the U.K. and France. Our team's engagement with customers had an immediate impact, resulting in new accounts and increasing penetration in existing accounts. Revenue from the U.K. and France in the fourth quarter increased 90% compared to the fourth quarter of 2022. Of this increase, 63% was attributable to increased unit volume. Our direct team is also able to focus more on the peripheral business in those countries, and we expect to see solid growth for peripheral IVL albeit off of a small base.

第四季度是英國和法國第一個完整的直銷季度。我們團隊與客戶的互動產生了立竿見影的效果，帶來了新客戶並提高了現有客戶的滲透率。與 2022 年第四季度相比，第四季度來自英國和法國的收入增長了 90%。其中 63% 歸因於單位數量的增加。我們的直接團隊也能夠更多地關注這些國家的外圍業務，我們預計外圍IVL將實現穩健增長，儘管基數較小。

Turning to Asia. We remain on track to receive PMDA approval for C2 in Japan in late Q1 or early Q2 2022. We expect to have reimbursement in place in Q4 at which time, we will begin launching C2 in Japan. We have also begun working with KOLs and the PMDA on a strategy to bring our peripheral products to the Japanese market.

轉向亞洲。我們仍有望在 2022 年第一季度末或第二季度初在日本獲得 PMDA 對 C2 的批准。我們預計將在第四季度獲得報銷，屆時我們將開始在日本推出 C2。我們還開始與 KOL 和 PMDA 合作制定將我們的周邊產品推向日本市場的戰略。

In China, we have made excellent progress with our joint venture and now expect to have approval for the ShockWave import, coronary and peripheral catheters later this year.

在中國，我們與合資企業取得了巨大進展，現在預計今年晚些時候將獲得 ShockWave 進口、冠狀動脈和外周導管的批准。

Finally, we are pleased to have started enrollment in a 1,000-patient post-market registry for our C2 product in India. Together with our distribution partner in India, we will gather high-quality data in what will be the biggest real-world registry for coronary IVL.

最後，我們很高興在印度開始為我們的 C2 產品進行 1,000 名患者的上市後登記。我們將與我們在印度的分銷合作夥伴一起，在現實世界最大的冠狀動脈 IVL 登記處收集高質量數據。

In closing, I'd like to thank our global commercial team and distribution partners for another strong year as they continue to bring IVL to more customers while dealing with the day-to-day challenges from COVID.

最後，我要感謝我們的全球商業團隊和分銷合作夥伴又一個強勁的一年，他們繼續為更多客戶帶來 IVL，同時應對新冠疫情帶來的日常挑戰。

Back to you, Doug.

回到你身上，道格。

Thanks, Isaac.

謝謝，艾薩克。

I will now touch on some other updates and highlights for the ShockWave business in 2021. Our success in securing reimbursement for both peripheral and coronary applications were, of course, some of our more important accomplishments in 2021.

現在，我將談談 2021 年 ShockWave 業務的一些其他更新和亮點。當然，我們在外周和冠狀動脈應用報銷方面取得的成功是我們 2021 年取得的一些更重要的成就。

On the coronary side, we were pleased to be granted a new technology add-on payment, or NTAP, for coronary IVL performed in the hospital inpatient setting as well as a transitional pass-through code for coronary IVL in the outpatient setting. And then in November, we had a big win for our peripheral business when the Centers for Medicare and Medicaid Services, or CMS, reassigned the payment for peripheral IVL procedures performed on above-the-knee arteries in the hospital outpatient setting. This rule, which became effective January 1, 2022, increases payments that hospitals receive when IVL is performed by itself or inductively with drug-coated balloons, stents or atherectomy in iliac, femoral and public teal arteries. Above-the-knee procedures are the large majority of peripheral cases and IVL procedures in hospitals are now paid on parity with atherectomy, which puts us on a level economic playing field for the first time. This uplift in payment was certainly excellent news, and we anticipate it will have a progressive positive impact on our above-the-knee business over time.

在冠狀動脈方面，我們很高興獲得針對在醫院住院患者中進行的冠狀動脈 IVL 的新技術附加付款 (NTAP) 以及針對在門診患者中進行的冠狀動脈 IVL 的過渡傳遞代碼。然後在 11 月份，當醫療保險和醫療補助服務中心 (CMS) 重新分配了在醫院門診環境中對膝上動脈進行的外圍 IVL 手術的付款時，我們的外圍業務取得了巨大的勝利。該規則於 2022 年 1 月 1 日生效，增加了醫院在自行進行 IVL 或在髂動脈、股動脈和公共青色動脈中使用藥物塗層球囊、支架或斑塊切除術誘導進行 IVL 時收到的費用。膝上手術佔絕大多數外圍病例，醫院中 IVL 手術的費用現在與斑塊旋切術相同，這使我們第一次處於公平的經濟競爭環境中。付款的增加無疑是個好消息，我們預計隨著時間的推移，這將對我們的膝上業務產生逐步的積極影響。

Also on the peripheral front, we are increasingly enthusiastic about the upcoming launch of M5+. We had briefly described this new product a few months back when we were commencing our limited market release.

同樣在外設方面，我們對即將推出的 M5+ 的熱情也越來越高。幾個月前，當我們開始有限的市場發佈時，我們曾簡要描述過這款新產品。

So as a reminder, compared to M5, M5+ has 3 meaningful upgrades. First, M5+ has a longer catheter shaft, which enables it to reach below the knee when using a femoral access or to reach the iliac and common femoral artery from the radial approach. Second, the plus version also comes in an 8-millimeter diameter size. A large percentage of iliac arteries are 8 millimeters. So having this larger size will help us further strengthen both our symptomatic iliac procedures as well as the large bore access segment of our business. And third, the feature that is resonating most in our limited release is the doubling of the pulse rate, sort of a double tap. Instead of taking 30 seconds to complete a cycle, it will now take 15 seconds with M5+. One physician told me a couple of weeks ago that he refuses to go back to M5 slow. He only wants to use M5 fast.

所以提醒一下，相比M5，M5+有3個有意義的升級。首先，M5+ 具有更長的導管軸，這使其能夠在使用股動脈入路時到達膝蓋下方，或從橈動脈入路到達髂動脈和股總動脈。其次，plus版本還有8毫米直徑的尺寸。大部分髂動脈的長度為 8 毫米。因此，擁有更大的尺寸將有助於我們進一步加強我們的症狀性髂骨手術以及我們業務的大口徑手術部分。第三，在我們的限量版中最引起共鳴的功能是脈衝頻率加倍，有點像雙擊。 M5+ 完成一個循環的時間不再是 30 秒，而是 15 秒。幾週前，一位醫生告訴我，他拒絕慢慢回到 M5。他只想快速使用M5。

Customers have responded to all these upgrades even more positively than we had anticipated. Our plan is now to switch from a limited release to a full launch of M5+ globally in the second quarter of this year.

客戶對所有這些升級的反應比我們預期的更加積極。我們現在的計劃是今年第二季度從有限發布轉為在全球全面發布 M5+。

As the pioneers of intravascular lithotripsy, we are constantly receiving feedback about what features and designs our customers are looking for, and we incorporate that into what is becoming an increasingly substantial product pipeline. The extremely positive initial response our customers have had to M5+ suggests that our team is doing a very good job of hearing what enhanced features our customers want. We have not described our portfolio in detail, but we are targeting 2 launches each year with a blend of meaningful performance and feature upgrades such as with M5+ as well as new configurations and designs that will expand the addressable patient population our customers are able to treat.

作為血管內碎石術的先驅，我們不斷收到有關客戶正在尋找的功能和設計的反饋，並將其納入日益豐富的產品線中。我們的客戶對 M5+ 的最初反應非常積極，這表明我們的團隊在傾聽客戶想要哪些增強功能方面做得非常好。我們尚未詳細描述我們的產品組合，但我們的目標是每年推出 2 款產品，融合有意義的性能和功能升級（例如 M5+）以及新的配置和設計，以擴大我們的客戶能夠治療的目標患者群體。

By 2025, we expect to have at least 6 different designs that our customers will be able to plug into our generator. And everything we will be selling then will be different and better than what we are selling today. Being first has its advantages.

到 2025 年，我們預計將擁有至少 6 種不同的設計，我們的客戶將能夠將其插入我們的發電機中。那時我們將銷售的所有產品都將與我們今天銷售的產品不同並且更好。成為第一有它的優勢。

To ensure we have the capacity to execute on the steady stream of products on our to-do list, we are well on our way towards more than doubling our R&D team from 40 talented individuals at the beginning of last year to what will likely be more than 100 by the end of this year.

為了確保我們有能力源源不斷地執行我們的待辦事項清單上的產品，我們正在努力將我們的研發團隊規模從去年初的 40 名優秀人員增加到一倍多，這一數字可能會更多到今年年底已超過100家。

And as our pipeline has advanced, so has our portfolio of intellectual property. We've continued to expand our patent estate, including continuations related to the 2 patents that were recently invalidated. Notably, the patent office issued these continuations after reviewing all the materials from the IPR process, which we included with the submission.

隨著我們的產品線不斷進步，我們的知識產權組合也在不斷進步。我們繼續擴大我們的專利範圍，包括與最近無效的兩項專利相關的延續。值得注意的是，專利局在審查了知識產權流程中的所有材料（我們將其包含在提交材料中）後發布了這些續訂。

There are many other apparatus and method claims in our portfolio of over 50 U.S. and over 70 foreign patents, the collective breadth of which gives us confidence that we have a very formidable patent position that is more than sufficient to protect our technology. We won't win just because we have a substantial patent estate, but we certainly won't lose because of patents either. Of course, we are constantly trying to stay one step ahead, serving our customers better than anyone else, creating unique new products that wow them and strengthen our patent portfolio as we innovate.

我們的 50 多項美國專利和 70 多項外國專利組合中還有許多其他設備和方法權利要求，這些專利的總廣度使我們相信我們擁有非常強大的專利地位，足以保護我們的技術。我們不會僅僅因為擁有大量專利而獲勝，但我們當然也不會因為專利而失敗。當然，我們不斷努力保持領先一步，比其他任何人都更好地為我們的客戶提供服務，創造出讓他們驚嘆的獨特新產品，並在我們創新的同時加強我們的專利組合。

We have also continued to advance the science around IVL, which has supported the expansion of calcium modification both in the peripheral and coronary vessels. We had multiple very impactful clinical presentations and publications over the quarter.

我們還繼續推進有關 IVL 的科學，這支持了外周血管和冠狀血管中鈣修飾的擴展。本季度我們發表了多項非常有影響力的臨床演示和出版物。

In October, at TCT, one year results from the DISRUPT CAD III clinical study of coronary IVL were presented for the first time and were subsequently published demonstrating the consistency of ShockWave coronary IVL outcomes over time across a wide spectrum of calcium morphologies and between genders.

10 月，在 TCT 上，首次公佈了 DISRUPT CAD III 冠狀動脈 IVL 臨床研究為期一年的結果，並隨後發表，證明了 ShockWave 冠狀動脈 IVL 結果隨著時間的推移在廣泛的鈣形態和性別之間的一致性。

Then earlier this month, results from the gender analysis of CAD III were highlighted in the new expert consensus statement in the journal of the Society for Cardiovascular Angiography and Interventions or SCAI. The consensus opinion was that due to the strength of the results, IVL may emerge as the first-line therapy for plaque modification in women. This is quite humbling coming from such an influential group.

本月早些時候，心血管造影和乾預協會 (SCAI) 雜誌上的新專家共識聲明強調了 CAD III 的性別分析結果。共識是，由於結果的強度，IVL 可能成為女性斑塊修飾的一線療法。來自這樣一個有影響力的團體，這是相當令人謙卑的。

Also in October, at the VIVA21 conference, a presentation of an interim analysis of our DISRUPT PAD III observational arm confirmed that IVL safely, effectively and consistently modifies calcium in complex calcified lesions across multiple peripheral vessel beds with a low need for bailout stenting, even in these very complex real-world cases. And in November, we enrolled the first patient in our DISRUPT BTK II global post-market study that is designed to assess the long-term benefit of peripheral IVL on the most challenging calcified below-the-knee lesions.

同樣是在 10 月，在 VIVA21 會議上，我們的 DISRUPT PAD III 觀察組的中期分析報告證實，IVL 可以安全、有效和一致地改變多個外周血管床複雜鈣化病變中的鈣，並且不需要緊急支架置入，甚至在這些非常複雜的現實案例中。 11 月，我們在 DISRUPT BTK II 全球上市後研究中招募了第一位患者，該研究旨在評估外周 IVL 對最具挑戰性的膝下鈣化病變的長期益處。

2021 was clearly an exceptional year for the company on the commercial front and things are lining up to make 2022 another excellent growth year. But none of this would have been possible without the stellar execution of our broader operational team. In the middle of COVID waves, supply chain chaos and nearly quadrupling of our sales in a single year, we never had a hint of a backorder or quality issue. That's pretty rare. And our team deserves an immense amount of credit for staying focused on doing everything they could for our customers and their patients.

2021 年對於該公司在商業方面顯然是不平凡的一年，一切都將使 2022 年成為另一個出色的增長年。但如果沒有我們更廣泛的運營團隊的出色執行力，這一切都是不可能實現的。在新冠疫情浪潮、供應鏈混亂以及我們的銷售額在一年內幾乎翻了兩番的情況下，我們從未出現過任何缺貨或質量問題的跡象。這是相當罕見的。我們的團隊專注於為我們的客戶及其患者竭盡全力，值得高度讚揚。

Commercially, we'll be in over 1,300 U.S. cath labs in the very near future, which means we will have successfully navigated our way through 1,300 VAC committees, no small feat. And on top of that, we opened a new clean room, leased a new building, so we can double our R&D lab, started shipping M5 catheters from our contract manufacturing partner and passed multiple audits, including MDR and MDSAP, rather remarkable that the team pulled all that off without a hitch.

從商業角度來看，我們將在不久的將來出現在超過 1,300 個美國導管實驗室中，這意味著我們將成功通過 1,300 個 VAC 委員會，這是一個不小的壯舉。最重要的是，我們開設了一個新的潔淨室，租了一座新大樓，這樣我們就可以將我們的研發實驗室擴大一倍，開始從我們的合同製造合作夥伴那裡運送 M5 導管，並通過了多項審核，包括 MDR 和 MDSAP，這對團隊來說是相當了不起的順利地完成了這一切。

With that, I will turn the call to Dan.

這樣，我就把電話轉給丹。

Thank you, Doug. Good afternoon, everyone.

謝謝你，道格。大家下午好。

ShockWave Medical's revenue for the fourth quarter ended December 31, 2021, was $84.2 million, a 271% increase from $22.7 million in the fourth quarter of 2020. U.S. revenue was $69.6 million in the fourth quarter of 2021, growing 449% and $12.7 million in the fourth quarter of 2020. The increase included $50.7 million from the coronary product, ShockWave C2, which was launched in the U.S. in February of 2021. The growth in the U.S. was also enhanced by continued sales force expansion.

ShockWave Medical 截至 2021 年 12 月 31 日的第四季度收入為 8420 萬美元，較 2020 年第四季度的 2270 萬美元增長 271%。 2021 年第四季度美國收入為 6960 萬美元，增長 449%，較 2020 年第四季度增長 1270 萬美元。 2020 年第四季度。這一增長包括來自 2021 年 2 月在美國推出的冠狀動脈產品 ShockWave C2 的 5070 萬美元。持續的銷售隊伍擴張也促進了美國的增長。

International revenue was $14.6 million in the fourth quarter of 2021, representing a 45% increase from $10 million in the fourth quarter of 2020. The increase in international revenue over the prior year reflects continued growth in customer demand and the expansion of our direct sales force in Europe.

2021 年第四季度國際收入為 1,460 萬美元，比 2020 年第四季度的 1,000 萬美元增長 45%。國際收入較上年增長反映了客戶需求的持續增長和我們直銷隊伍的擴張在歐洲。

Looking at our product lines, our peripheral products, ShockWave M5 and ShockWave S4 accounted for $21.4 million of total revenue in the fourth quarter of 2021 compared to $14.1 million in the fourth quarter of 2020, a 52% increase.

從我們的產品線來看，我們的外設產品 ShockWave M5 和 ShockWave S4 佔 2021 年第四季度總收入的 2140 萬美元，而 2020 年第四季度為 1410 萬美元，增長了 52%。

Our coronary product, ShockWave C2, accounted for $62.3 million of total revenue in the fourth quarter of 2021 compared to $8.2 million in the fourth quarter of 2020, representing a 661% increase. In addition, the sales of generators contributed $0.5 million in revenue in the fourth quarter of 2021, which is the same as the fourth quarter of 2020.

我們的冠脈產品 ShockWave C2 在 2021 年第四季度的總收入中佔 6230 萬美元，而 2020 年第四季度為 820 萬美元，增長了 661%。此外，發電機的銷售在2021年第四季度貢獻了50萬美元的收入，與2020年第四季度持平。

Gross profit for the fourth quarter of 2021 was $71.5 million compared to $16.2 million in the fourth quarter of 2020.

2021 年第四季度的毛利潤為 7150 萬美元，而 2020 年第四季度的毛利潤為 1620 萬美元。

Gross margin for the fourth quarter of 2021 was 85% as compared to 72% in the fourth quarter of 2020. The improvement in gross margin was partly driven by product mix as well as continued improvement in productivity and process efficiencies.

2021 年第四季度的毛利率為 85%，而 2020 年第四季度為 72%。毛利率的改善部分歸功於產品組合以及生產力和流程效率的持續改善。

Total operating expenses for the fourth quarter of 2021 were $57.5 million, a 79% increase from $32.1 million in the fourth quarter of 2020.

2021 年第四季度的總運營費用為 5750 萬美元，比 2020 年第四季度的 3210 萬美元增長 79%。

Sales and marketing expenses for the fourth quarter of 2021 were $33.2 million compared to $16.4 million in the fourth quarter of 2020. The increase was primarily driven by sales force expansion.

2021 年第四季度的銷售和營銷費用為 3320 萬美元，而 2020 年第四季度為 1640 萬美元。這一增長主要是由銷售隊伍擴張推動的。

R&D expenses for the fourth quarter of 2021 were $14.7 million compared to $9 million in the fourth quarter of 2020. The increase was primarily driven by headcount growth.

2021 年第四季度的研發費用為 1,470 萬美元，而 2020 年第四季度的研發費用為 900 萬美元。這一增長主要是由員工數量增長推動的。

General and administrative expenses for the fourth quarter of 2021 were $9.6 million compared to $6.6 million in the fourth quarter of 2020. The increase was primarily driven by higher headcount to support the growth of the business.

2021 年第四季度的一般及管理費用為 960 萬美元，而 2020 年第四季度為 660 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所致。

Net income for the fourth quarter of 2021 was $12.9 million compared to a net loss of $15.9 million in the fourth quarter of 2020. Basic net income per share for the period was $0.37. Diluted net income per share for the period was $0.34. We ended the fourth quarter of 2021 with $201 million in cash, cash equivalents and short-term investments.

2021 年第四季度淨利潤為 1290 萬美元，而 2020 年第四季度淨虧損為 1590 萬美元。該期間每股基本淨利潤為 0.37 美元。該期間稀釋後每股淨利潤為 0.34 美元。截至 2021 年第四季度末，我們的現金、現金等價物和短期投資為 2.01 億美元。

Finally, I'd like to briefly recap some highlights from our full year 2021 results. Total ShockWave revenue for the full year 2021 was $237.1 million, an increase of 250% compared to full year 2020 revenues of $67.8 million. Revenue from the U.S. for the full year 2021 was $186.3 million, representing a 402% increase over 2020 revenue of $37.1 million.

最後，我想簡要回顧一下我們 2021 年全年業績的一些亮點。 ShockWave 2021 年全年總收入為 2.371 億美元，比 2020 年全年收入 6780 萬美元增長 250%。 2021 年全年來自美國的收入為 1.863 億美元，比 2020 年的 3710 萬美元收入增長 402%。

International revenue was $50.8 million for the full year 2021 compared to $30.7 million in 2020, representing a 66% increase. The gross margin for the full year 2021 was 83% compared to 69% in 2020. Total operating expenses were $196.6 million in 2021, an increase of 75% compared to operating expenses of $112.5 million in 2020. Total net loss for the full year 2021 was $9.1 million compared to a net loss of $65.7 million in 2020.

2021 年全年國際收入為 5,080 萬美元，較 2020 年的 3,070 萬美元增長 66%。 2021 年全年毛利率為 83%，而 2020 年為 69%。2021 年總運營費用為 1.966 億美元，比 2020 年運營費用 1.125 億美元增長 75%。2021 年全年淨虧損總額2020 年淨虧損為 910 萬美元，而淨虧損為 6570 萬美元。

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。

Thanks, Dan.

謝謝，丹。

As I look back at what our team accomplished in 2021, the list is both long and impressive, particularly given the extraordinary challenges that have faced all of us for the past 2 years. It's such a privilege to be part of this team and to be associated with such a game-changing technology.

當我回顧我們團隊在 2021 年取得的成就時，這份清單既長又令人印象深刻，特別是考慮到我們所有人在過去兩年中面臨的非凡挑戰。能夠成為這個團隊的一員並與這種改變遊戲規則的技術聯繫在一起真是一種榮幸。

Thank you all for joining us today and for your continued support.

感謝大家今天加入我們並繼續支持。

(Operator Instructions) Our first question comes from 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。

I wanted to start with the full year guidance that you provided and just drill down there a little bit. Would love to get some additional color by segments. I think if I heard correctly, I think you made the comment, Doug, that ATK -- or I'm sorry, peripheral growth rather should accelerate next year. Did I hear that right behind the reimbursement change? So maybe just talk a little bit about peripheral versus coronary.

我想從您提供的全年指導開始，然後再深入研究一下。希望通過分段獲得一些額外的顏色。我想如果我沒聽錯的話，我想你說過，道格，ATK——或者我很抱歉，外圍的增長明年應該會加速。我是在報銷變更後聽到的嗎？所以也許只是談談外周血管和冠狀動脈。

And then also kind of how you're contemplating additional items like any potential staffing or capacity issues and just broader, pace of procedure volume recovery? And then I have a follow-up.

然後，您還如何考慮其他項目，例如任何潛在的人員配備或容量問題以及更廣泛的程序量恢復速度？然後我有一個後續行動。

Yes. Thanks, Adam, and I'll tag team with Isaac on this. So the -- we're -- we think the combination of M5+ and improved reimbursement along with the expansion of our staffing in the field and sort of maturation of the launch on coronary are all factors that augur towards an acceleration in peripheral growth this year in the U.S. The response to M5+ has been, frankly, more positive. We were excited about the product, and we're more excited about it now after seeing how much our -- how positive our customers respond to it.

是的。謝謝，亞當，我將在這方面與艾薩克合作。因此，我們認為，M5+ 和改善報銷的結合，以及我們在該領域的人員配備的擴大以及冠狀動脈的推出的成熟，都是預示著今年周邊地區增長加速的因素坦率地說，美國對 M5+ 的反應更為積極。我們對這個產品感到很興奮，在看到我們的客戶對此有多麼積極的反應後，我們更加興奮了。

The above-the-knee uplift in payment, which is tremendous for us is -- we think, is likely to be a steadier, multi-quarter positive impact. I certainly saw it in the field when I spent a week, 1.5 weeks in the field, visiting with customers. It doesn't sink in right away with them, particularly the physicians that we essentially just doubled the payment level for -- or the hospitals payment level has just doubled for the standard ShockWave as a stand-alone procedure.

我們認為，膝蓋以上的付款增長對我們來說是巨大的，這可能會產生更穩定的、多個季度的積極影響。當我花了一周（1.5 週）在現場拜訪客戶時，我確實在現場看到了這一點。他們並沒有立即接受這一點，特別是我們基本上只是將支付水平提高了一倍的醫生，或者將標準 ShockWave 作為獨立程序的醫院支付水平剛剛提高了一倍。

And to some extent, that's really a positive. We want to have a steady incremental impact over time, not like a light switch that happens one week and then is behind them. And so I think in that area, it's going to take a little bit longer to sort of remind folks regularly, make sure the physicians and administrators are all aware of the fact that ShockWave is -- above-the-knee is now actually both incredibly positive clinically, but now positive economically as well for the center.

在某種程度上，這確實是積極的。我們希望隨著時間的推移產生穩定的增量影響，而不是像電燈開關一周發生一次然後就過去了。所以我認為在這個領域，需要更長的時間來定期提醒人們，確保醫生和管理人員都意識到 ShockWave 的事實——膝蓋以上現在實際上是令人難以置信的臨床上是積極的，但現在該中心的經濟上也是積極的。

In terms of staffing, Isaac, maybe you want to just talk a little bit philosophically about how you're thinking about the field.

在人員配置方面，艾薩克，也許你只想從哲學角度談談你對這個領域的看法。

Yes. I think it should be a very positive year for the peripheral business, particularly above-the-knee with the product launch and reimbursement change, as Doug said. And we expect that momentum to build throughout the year. The comps in '21 were a little off in places due to heavier COVID impact in '20. And then we'll -- as we got -- if you're looking at '22, at least what we're seeing so far is staffing shortages, and that's a global phenomenon. And likely, though, we think those cases will be there when staffing is there. And so there might be a little shift back and forth. But I think early in the year here, we've seen staffing shortages, coupled with Omicron causing some challenges coming into the year. But it looks to be getting better, I think. And I'd say that's true on a global perspective with -- from a major country standpoint, with Germany may be being a little behind the curve still in terms of where they're at with COVID sweeping through.

是的。正如 Doug 所說，我認為對於外圍設備業務來說，今年應該是非常積極的一年，特別是在產品推出和報銷變化的膝蓋以上業務。我們預計這一勢頭將在全年持續增強。由於 20 年受新冠疫情影響較重，21 年的比較在某些地方略有偏差。然後，正如我們所得到的那樣，如果你關注 22 年，至少到目前為止我們看到的是人員短缺，這是一個全球現象。不過，我們認為，當人員配備到位時，這些案例很可能就會出現。因此可能會有一些來回的轉變。但我認為今年年初，我們已經看到人員短缺，再加上 Omicron 給今年帶來了一些挑戰。但我認為，情況似乎正在好轉。我想說，從全球角度來看，這是事實——從一個主要國家的角度來看，德國在新冠疫情席捲全球方面可能仍然有點落後。

What I don't -- I'm not sure about yet, at least in my sort of small sample size in the field, the -- one of the centers I was in was lamenting how incredibly sick their peripheral patients were that were coming in, sort of biased more severe, which may accrue to our benefit since we treat the more severe stuff. But these are patients who had been kept out of the hospital longer than they should have. So by the time they came in, they went from leg pain to open wounds and much more severe disease.

我還不確定，至少在我所在領域的小樣本量中，我所在的一個中心正在感嘆他們的外圍病人即將到來，病情有多麼嚴重在某種程度上，偏向更嚴重，這可能會給我們帶來好處，因為我們治療的是更嚴重的東西。但這些患者的住院時間超出了應有的時間。因此，當他們進來時，他們的腿痛已經變成了開放性傷口和更嚴重的疾病。

So that may be one of the things we see is a tendency over the next quarter or so as you're catching up on cases, you may get the sicker people who were, once again, being kept out of the hospital because of COVID restrictions and staffing shortages.

因此，這可能是我們看到的趨勢之一，即下個季度的趨勢，或者當你趕上病例時，你可能會發現病情較重的人，因為新冠病毒的限制，他們再次被排除在醫院之外。和人員短缺。

Okay. Got it. That's a very helpful fulsome response. And maybe I'll just pivot to the second question, and it's on the pipeline. And I think, Doug, you talked about having 6 different catheter designs that you can plug into the generator by 2025, if I heard you right. I know you're being close to the vest here intentionally. But wondering if you're willing to at least say if these are going to kind of be in the same areas where you're already playing in that being coronary and peripheral artery disease. Or if you anticipate you'll be playing in kind of adjacent markets by that time as well. Just any additional color there that you're willing to provide would be great.

好的。知道了。這是一個非常有幫助且充實的回應。也許我會轉向第二個問題，它正在醞釀之中。我想，Doug，您談到了 6 種不同的導管設計，如果我沒聽錯的話，您可以在 2025 年之前將它們插入發電機中。我知道你是故意保守秘密的。但想知道您是否願意至少說一下這些是否會與您已經從事的冠狀動脈和外周動脈疾病領域相同。或者，如果您預計到那時您也將涉足鄰近市場。只要您願意提供任何額外的顏色就可以了。

Yes. Commercially, by 2025, I would expect it will be in the peripheral and coronary segments, longer-term, TBD.

是的。從商業角度來看，到 2025 年，我預計它將應用於外周和冠狀動脈部分，從長遠來看，待定。

And I'd just add importantly, to be clear, they won't be interchangeable products. For instance, there won't be 2 products that could -- you could use either/or in a specific vessel or clinical situations. They'll be 6 distinct products, distinct applications, distinct indications.

我想補充一點，需要明確的是，它們不會是可互換的產品。例如，不會有兩種產品可以——您可以在特定的血管或臨床情況下使用其中之一/或。它們將是 6 種不同的產品、不同的應用、不同的適應症。

Next question comes from Larry Biegelsen with Wells Fargo.

下一個問題來自富國銀行的拉里·比格爾森。

And I'll echo Adam's congratulations, a pretty remarkable year for you guys. So Doug, I wanted to start on international. Is there any revenue in the 2022 guide for Japan? And in China, I thought that was a new update that you slipped in there. Correct me if I'm wrong, but -- that you have approval for peripheral and coronary of the imported product by the end of this year. So can you confirm that that's the timing's move forward and how you see that opportunity? And I had a follow-up.

我也向 Adam 表示祝賀，對你們來說這是非常了不起的一年。所以道格，我想從國際比賽開始。 2022年日本指南有收入嗎？在中國，我認為這是您插入的新更新。如果我錯了，請糾正我，但是——今年年底你們已經批准了進口產品的外周和冠狀動脈。那麼您能否確認這就是時間的推移以及您如何看待這個機會？我有一個後續行動。

Yes. So working backwards, China, good catch. We did pull it in a year or 2 because we had -- up until today, we had been saying 2023, 2024. So we -- our team in concert with Genesis has done a really good job. It's still a little bit unclear exactly when this year it will be approved. Like any regulatory body, it's a little bit murky in China or -- hard to pin down with precision.

是的。所以倒著來說，中國，做得很好。我們確實在一兩年內就實現了這一目標，因為直到今天，我們一直在說 2023 年、2024 年。因此，我們的團隊與 Genesis 合作，做得非常好。目前還不清楚今年何時會獲得批准。與任何監管機構一樣，中國的情況有點模糊，或者說很難精確確定。

PMDA, on the other hand, we feel pretty confident that best case, end of March worse -- sort of less best case, maybe sometime in May. So sometime in the next few months, we have a high degree of confidence that we will be approved but to really get any commercial traction in Japan that would be worth changing our numbers for, you really need reimbursement. And we won't have -- we will not have reimbursement until the end of the year. So once approved, we'll apply to MHLW to get to -- to figure out what the reimbursement level will be, and then we'll be able to start fully commercializing essentially in 2023.

另一方面，PMDA 我們非常有信心，最好的情況是 3 月底，情況會更糟——不太理想的情況可能是 5 月的某個時候。因此，在接下來幾個月的某個時候，我們對獲得批准充滿信心，但要真正在日本獲得任何值得改變我們的數字的商業吸引力，你確實需要報銷。直到今年年底我們才會得到報銷。因此，一旦獲得批准，我們將向 MHLW 申請確定報銷水平，然後我們基本上可以在 2023 年開始全面商業化。

Yes. So Larry, the guidance contemplates a small amount of revenue contribution from Japan and China this year. And that's, as Doug said, uncertainty on timing in China and just blocking and tackling time line in Japan to get reimbursement and then launch.

是的。拉里，該指南考慮了今年日本和中國的少量收入貢獻。正如道格所說，這就是中國時間安排的不確定性，而日本只是阻止和解決獲得報銷然後啟動的時間表。

Got it. Just one for Dan and then and one for Doug. Just Dan, on the P&L, how should we think about operating margin in '22? And Doug, obviously, there was a lot of noise this quarter on competition. Maybe just a little bit more color on how you protect your first-mover advantage and when you expect competition in Europe and the U.S.

知道了。只給丹一份，然後給道格一份。 Dan，關於損益表，我們應該如何考慮 22 年的營業利潤率？顯然，道格本季度有很多關於競爭的噪音。也許只是關於如何保護先發優勢以及何時預計歐洲和美國的競爭有更多的色彩。

Sure. We're going to continue to invest in the business. As Doug alluded to, we're going to invest heavily in R&D, and we're excited about that. With that said, we're still expecting to get some more leverage out of the business as the year moves on, given the revenue ramp. So things are -- the trend is good for this year and into next year, I'd say.

當然。我們將繼續投資該業務。正如道格提到的，我們將在研發方面投入大量資金，我們對此感到興奮。話雖如此，考慮到收入的增長，我們仍然預計隨著時間的推移，我們將從業務中獲得更多的槓桿作用。所以，我想說，今年和明年的趨勢都是好的。

In terms of potential competition in the future, as you and Isaac talked when we talked about publicly, we anticipated given the extremely positive response we've had from our customers that we would have competition as soon as 2024. So nothing has really changed from our perspective other than people have stated publicly that they intend to compete. While we are extremely bullish about our patent portfolio in the electrohydraulic lithotripsy arena, and we'll certainly assert that against anybody who tries to copy what we're doing, we are by no means sort of sitting back and waiting and intending to win through litigation. That's sort of a foolish strategy and that doesn't do anything to make things better for our customers.

就未來的潛在競爭而言，正如您和 Isaac 在我們公開談論時所說的那樣，鑑於我們從客戶那裡得到的極其積極的回應，我們預計我們最早將在 2024 年面臨競爭。所以，從我們的觀點以外的人都公開表示他們打算競爭。雖然我們非常看好我們在電液碎石領域的專利組合，並且我們肯定會斷言，反對任何試圖複製我們正在做的事情的人，但我們絕不是坐以待斃，並打算贏得勝利訴訟。這是一種愚蠢的策略，並且無助於為我們的客戶帶來更好的生活。

So I think what you heard today was a more public commentary on how intensely we've been approaching our product development activities because we think hiring the best engineers is as important as hiring the best salespeople and in some ways, more important because they're the ones who create these great problem-solving technologies to feed to the sales team. And we have more than doubled the number of projects in our product pipeline over the past 12 months. And we're quite bullish based on the feedback we've been getting from customers who've been sort of helping us think through what we ought to be prioritizing.

因此，我認為您今天聽到的是關於我們如何積極開展產品開發活動的更公開的評論，因為我們認為僱用最好的工程師與僱用最好的銷售人員一樣重要，並且在某些方面更重要，因為他們那些創造出這些偉大的解決問題技術並為銷售團隊提供幫助的人。在過去 12 個月裡，我們的產品線中的項目數量增加了一倍多。根據我們從客戶那裡得到的反饋，我們非常樂觀，他們幫助我們思考了應該優先考慮的事情。

So we're -- we intend to win by innovating and creating better products for our customers. And we think it will be helpful that if and when competition shows up, we will have multiple things to plug into our generator that will be better than what we're selling today. So whatever product people think they're going to be competing with, it will probably be actually different than what they will be competing with when they do try to enter the market.

因此，我們打算通過創新和為客戶創造更好的產品來贏得勝利。我們認為，如果競爭出現，我們將有多種東西可以插入我們的發電機，這些東西將比我們今天銷售的更好，這將是有幫助的。因此，無論人們認為他們將與什麼產品競爭，它實際上可能與他們嘗試進入市場時將要競爭的產品不同。

Our next question comes from Bill Plovanic with Canaccord.

我們的下一個問題來自 Canaccord 的 Bill Plovanic。

First of all, congratulations, I don't think I've ever seen a company outperform initial expectations by over $100 million in a year at this size. So that's pretty impressive in my career.

首先，恭喜你，我認為我還沒有見過一家公司在一年內的業績超出最初預期超過 1 億美元（以這種規模）。所以這在我的職業生涯中是相當令人印象深刻的。

My questions are, first, in terms of guidance, how should we think of first quarter '22 -- given the commentary as it relates to the fourth quarter? I mean, I think last year, you were up 40% sequentially. I don't think that's realistic because of the C2 launch, but I just wonder if you could help us understand that.

我的問題是，首先，就指導而言，考慮到與第四季度相關的評論，我們應該如何看待 22 年第一季度？我的意思是，我認為去年您的業績環比增長了 40%。由於 C2 的推出，我認為這是不現實的，但我只是想知道您是否可以幫助我們理解這一點。

Second question is M5 as a percent of U.S. sales. And then just a broader question on what -- in terms of the usage today, how much of the use is in severely calcified lesions and what do you think percentage you're starting to see in moderately calcified lesions?

第二個問題是 M5 占美國銷售額的百分比。然後是一個更廣泛的問題，就目前的使用情況而言，有多少使用量用於嚴重鈣化病變，以及您認為在中度鈣化病變中開始看到的百分比是多少？

So -- thanks, by the way, for the kind words. The first quarter is going to be an interesting one. I mean, I was talking to a doc who one of the top TAVR centers. And in January, they would have expected to do like 60 or 70 TAVRs, and they did 3. Now that's a more severe downdraft than we've seen in our business, but it's representative of how severely some hospital shutdown procedures. Because if they shut down TAVRs, they're certainly shutting down like procedures in a lot of the coronaries.

所以——順便說一句，謝謝你的客氣話。第一季度將是一個有趣的季度。我的意思是，我正在和一位頂級 TAVR 中心之一的醫生交談。一月份，他們預計會進行 60 或 70 例 TAVR，結果他們做了 3 例。現在，這是比我們在業務中看到的更嚴重的下滑，但它代表了一些醫院關閉程序的嚴重程度。因為如果他們關閉 TAVR，他們肯定會關閉很多冠狀動脈手術。

So that was loosening up end of January, even in the most severely shut down. But it's a little earlier for us to say with certainty that there's going to be -- how much of a catch-up there will be in March because you also have the staffing constraints that kind of prevent you from an overshoot. So we think all those old cases will get cleaned out. It's just going to be cleaned out over time.

因此，即使是在最嚴重的封鎖時期，這種情況在一月底也有所放鬆。但我們現在就可以肯定地說，三月份會有多少追趕，還為時過早，因為人員配備方面的限制也防止了超調。所以我們認為所有這些舊病例都會被清除。隨著時間的推移，它就會被清理掉。

So you are right to assume that the kind of quarter-on-quarter growth that we saw a year ago when we had a product launch is not achievable, given the fact that we had a product launch in the middle there and we have the COVID downdraft in the first 6-ish weeks of the quarter as we're anticipating will be. So as you're modeling, I think probably modeling the whole sector, you probably want to model a lighter Q1 than you otherwise would have, had it not been for Omicron. Because I think Omicron affected Q1 more than it affected Q4 probably.

因此，你的假設是正確的，考慮到我們在中間推出了產品，而且我們有新冠病毒，我們一年前推出產品時看到的那種季度環比增長是不可能實現的。正如我們預期的那樣，本季度的前 6 週左右會出現下滑。因此，當您進行建模時，我認為可能是對整個部門進行建模，如果沒有 Omicron，您可能想要建模一個比原本更輕的 Q1。因為我認為 Omicron 對第一季度的影響可能比對第四季度的影響更大。

In terms of M5's role in our U.S. peripheral business, it's most of it. We have a nice S4 business. Don't want to lose it. M5 is the business by and large. It's a preponderance of our U.S. and even more so, it's the preponderance of our global business. So the fact that we're launching M5+ globally is going to be a meaningful upgrade for all of our peripheral customers and probably for future as yet not converted to peripheral customers.

就M5在我們美國周邊業務中的作用而言，它是大部分。我們有很好的 S4 業務。不想失去它。總的來說，M5 是一家企業。這是我們美國的優勢，更是我們全球業務的優勢。因此，我們在全球範圍內推出 M5+，對於我們所有的外設客戶來說都是一次有意義的升級，而且可能對於未來尚未轉換為外設客戶的客戶來說也是一次有意義的升級。

In terms of the mix of severe and moderate, most -- less than 10% of the docs in the U.S. do intervascular imaging. And the only way to really quantify how much calcium is there is, is to do IVUS or CT. If you look at an X-ray image or fluoroimage, they say to look at whether you see calcium on both sides of the vessels. So you see this looks -- it looks like rails, so these white lines outside on the sides of the vessel. And that tells you if you have severe calcium or not, kind of objective. Yes, you're looking at an image, but it's not like you take a blood test and say, "Oh, Doug has severe and Isaac has mild.

就嚴重和中度的情況而言，美國大多數（不到 10%）的醫生進行了血管間成像。真正量化鈣含量的唯一方法是進行 IVUS 或 CT。他們說，如果您查看 X 射線圖像或熒光圖像，請查看血管兩側是否看到鈣。你看，它看起來像鐵軌，所以這些白線位於容器的側面。這可以客觀地告訴您您的鈣含量是否嚴重。是的，你正在看一張圖像，但這並不像你在進行血液檢查時說，“哦，道格患有嚴重的，而艾薩克患有輕微的。

So it's unknowable what percent of our cases are "moderate" now. Certainly, we are treating moderate patients or our customers are treating modern patients because they probably put an inflated balloon. It doesn't inflate well and they stop and they put in ShockWave and it works really well. So it's -- I don't know if we'll ever know what percent is severe and what percent is moderate. I think it's almost all of our cases are cases where the doctor has either failed something else or so sure they're going to fail something else that they ShockWave. And so it's severe enough is the way I would look at it.

所以現在不知道我們的病例中有多少是“中等”的。當然，我們正在治療中度患者，或者我們的客戶正在治療現代患者，因為他們可能放了一個充氣的氣球。它充氣不好，他們停下來，放入 ShockWave，效果非常好。所以，我不知道我們是否會知道什麼百分比是嚴重的，什麼百分比是中等的。我認為幾乎我們所有的病例都是醫生要么在其他事情上失敗了，要么確信他們會在其他事情上失敗，以至於他們使用了 ShockWave。所以我認為這已經足夠嚴重了。

Okay. And then when we think of the BTK, DISRUPT BTK II study, when can IVL replace mechanical atherectomy devices? And -- but when will also atherectomy still be needed? And if you kind of look at the cases, I know we've seen 5% penetration, I think it's something like that with atherectomy today, especially BTK, but maybe it's higher. But what do you think it -- you could displace there? That's my question.

好的。然後當我們想到BTK、DISRUPT BTK II研究時，IVL什麼時候可以取代機械斑塊切除設備？而且——但是什麼時候還需要進行旋切術呢？如果你看一下這些案例，我知道我們已經看到了 5% 的滲透率，我認為這與今天的斑塊切除術類似，尤其是 BTK，但也許更高。但你覺得怎麼樣——你可以取代那裡嗎？這就是我的問題。

Yes, Bill, thanks for the question. I think like we see -- like we've talked about, ultimately, I think we view atherectomy as a complementary technology, whether that's below the knee, above-the-knee or in the coronaries. When you get below the knee, I think there's larger lumens, again, where you can get -- you can get a balloon, an IVL balloon. These tend to have, I think, we can benefit a lot from having a very atraumatic IVL below-the-knee that's not going to cause severe dissections, and can crack the medial calcium and help the vessel expand ultimately.

是的，比爾，謝謝你的提問。我認為，正如我們所看到的，就像我們所討論的，最終，我認為我們將斑塊切除術視為一種補充技術，無論是在膝蓋以下、膝蓋以上還是在冠狀動脈中。當你到達膝蓋以下時，我認為有更大的管腔，再次，你可以在那裡 - 你可以得到一個氣球，一個 IVL 氣球。我認為，我們可以從膝蓋以下的非常無創傷的 IVL 中受益匪淺，這種 IVL 不會導致嚴重的解剖，並且可以破裂內側鈣並最終幫助血管擴張。

I think with atherectomy, if you got tighter lesions, you get a wire across then -- and you can't get a balloon across, then you got to open that up with atherectomy. And I think a lot of times in doing that, that might be a definitive prep for the vessel and you'll follow it with a balloon or maybe someday a DCB. So I don't think there's a conversion that we have. I think what we're looking for is demonstrating through data and with improved products that we are a good solution for a lot of below-the-knee calcified lesions, but not a solution that necessarily does away with that atherectomy.

我認為，通過斑塊旋切術，如果病變部位較緊，則需要用一根導線穿過，而氣球無法穿過，那麼您必須通過斑塊旋切術將其打開。我認為很多時候這樣做，這可能是對船隻的明確準備，你會用氣球或者也許有一天用 DCB 來跟隨它。所以我不認為我們有任何轉變。我認為我們正在尋找的是通過數據和改進的產品來證明我們是許多膝下鈣化病變的良好解決方案，但不是必然消除斑塊切除術的解決方案。

(Operator Instructions) Our next question comes from Cecilia Furlong with Morgan Stanley.

（操作員說明）我們的下一個問題來自摩根士丹利的塞西莉亞·弗隆。

I'll echo everyone else's congrats on another strong execution quarter for the team. I wanted to ask, Doug, just on coronary, with NTAP now in place, what have you seen from an inpatient outpatient procedure volume mix? And as you look beyond the COVID impacted type of environment, where do you see this going longer term?

我將響應其他所有人的祝賀，祝賀團隊又一個強勁的執行季度。我想問道格，就冠狀動脈而言，NTAP 現已就位，您從住院門診手術量組合中看到了什麼？當您超越受新冠疫情影響的環境類型時，您認為這種情況的長期發展會如何？

We don't have data on the macro coronary inpatient outpatient mix outside of ShockWave and probably won't for another, I don't know, a year. Because it usually takes a little while for [our panel] to get to collect it. And in our own cases, we kind of don't care. So we don't care. The doctor often doesn't know, am I going to keep the patient overnight, not to keep the patient overnight. It's not really part of our conversation. We may meet with the -- well, we do meet with the administrative folks at the hospital who do the coding to make sure that they know how to code NTAP and how to code transitional pass-through. I think the effect that both transitional pass-through in July and NTAP in November had was that they -- and predominantly, it was when transition pass-through came through, they drastically, dramatically reduced the economic anxiety that cath lab directors and physicians had when using ShockWave.

我們沒有 ShockWave 之外的宏觀冠狀動脈住院門診組合的數據，並且可能再過一年（我不知道）也不會。因為[我們的小組]通常需要一段時間才能收集它。就我們自己的情況而言，我們並不關心。所以我們不在乎。醫生常常不知道，我是要讓病人過夜，還是不要讓病人過夜。這並不是我們談話的一部分。我們可能會與醫院的管理人員會面，他們負責編碼，以確保他們知道如何編碼 NTAP 以及如何編碼過渡傳遞。我認為 7 月的過渡傳遞和 11 月的 NTAP 所產生的影響是，主要是當過渡傳遞發生時，它們極大地減少了導管實驗室主任和醫生的經濟焦慮使用 ShockWave 時。

Prior to that, certainly, we couldn't get through some VAC committees and pricing and cost was a constant, constant topic because we did not have an incremental payment on top of the standard PCI payments levels. And while there's still conversation about price and budgets and the like, the fact that we do have add-on payments, we have something to address that economic anxiety, which we didn't have before July. So I don't -- what's quite evident to me and maybe Isaac will have something to correct me on, but I don't think anybody said, "Oh, well, now that you have NTAP, I'm going to do more inpatient procedures." I think they are now able to treat the patient in any way they see fit. And if they think the best way to treat a patient is using ShockWave, they don't feel guilty using ShockWave or they don't have to be reluctant to ShockWave, which they probably would have been particularly over time if we did not get these extra payments, they probably would have been under more pressure from administration, which now they should be under less pressure.

當然，在此之前，我們無法通過一些 VAC 委員會的審查，定價和成本是一個持續不斷的話題，因為我們沒有在標準 PCI 付款水平之上進行增量付款。雖然仍在討論價格和預算等問題，但事實上我們確實有附加付款，但我們有一些東西可以解決七月份之前我們沒有的經濟焦慮。所以我不認為——這對我來說是很明顯的，也許艾薩克會糾正我，但我不認為有人會說，“哦，好吧，既然你有了 NTAP，我會做更多的事情住院程序。”我認為他們現在能夠以他們認為合適的任何方式治療患者。如果他們認為治療患者的最佳方法是使用 ShockWave，他們不會對使用 ShockWave 感到內疚，或者他們不必不願意使用 ShockWave，如果我們沒有得到這些，隨著時間的推移，他們可能會特別不願意使用 ShockWave額外的付款，他們可能會受到來自政府的更大壓力，而現在他們應該受到更少的壓力。

Yes, I think that's right, Doug. I think the -- with where the payments are at now and the transitional pass-through an NTAP, there is no kind of overhang either way on what the physician does and what the patient needs for treatment. I do think if you think about it from a patient physician perspective, if you're going in for an elective PCI, let's say, and the physician thinks you should be able to go home that day with an outpatient procedure, the best thing for that patient and the physician is that the patient gets out of the hospital and goes home. And what really, I think the way we think about it from an IVL standpoint, is it's a safe procedure. It doesn't create complications during the procedure. And so more likely than not, if that patient was intended to go home, you're not -- IVL is going to help make sure that patient goes home that day, which is a great thing.

是的，我認為是對的，道格。我認為，根據目前的付款情況以及 NTAP 的過渡傳遞，醫生的工作和患者的治療需求都不存在任何懸而未決的情況。我確實認為，如果您從患者醫生的角度考慮，如果您打算進行選擇性 PCI，比方說，醫生認為您應該能夠在當天接受門診手術回家，這對您來說是最好的選擇病人和醫生的關係就是病人出院回家。事實上，我認為從 IVL 的角度來看，這是一個安全的程序。它不會在手術過程中造成並發症。因此，如果該患者打算回家，您很可能不會 - IVL 將幫助確保患者當天回家，這是一件好事。

And if I could ask a few questions just on your international business as well. How you're thinking about U.K. and France contributions to international sales in 2022. What you contemplated in your guidance just directionally?

我也可以問一些有關您的國際業務的問題嗎？您如何看待英國和法國對 2022 年國際銷售的貢獻？您在指導中的方向性考慮是什麼？

And then looking to 2023 as well, how you view the ramp in Japan versus China? Just any comments on a relative basis, how you view those 2 markets ramping beginning really in 2023?

然後展望 2023 年，您如何看待日本與中國的增長？只是相對而言，您如何看待這兩個市場在 2023 年真正開始增長？

Yes, sure. So the dynamic in the U.K. and France is a bit different because in the U.K., we had a sales agent that was -- where we recognized the revenues that were sold at kind of full ASP. So as we switch to a direct sales team, the benefit in the U.K. will be volume. And that will be predominantly, I think near-term volume on coronary as they get more penetration in the existing accounts because there's more focus on the product, and there's more focus on teaching physicians, more physicians. And longer term, on peripheral as the team will actually focus on using IVL for pre TAV, using IVL for iliacs and the appropriate peripheral situations.

是的，當然。因此，英國和法國的動態有點不同，因為在英國，我們有一個銷售代理，在那裡我們確認以全價銷售的收入。因此，當我們轉向直銷團隊時，在英國的好處將是數量。我認為，這將主要是冠狀動脈的近期交易量，因為它們在現有賬戶中獲得更多滲透，因為人們更加關注產品，並且更加關注教導醫生、更多醫生。從長遠來看，在外周方面，團隊實際上將重點放在使用 IVL 進行 TAV 前、使用 IVL 進行髂肌和適當的外周情況。

In France, there's a benefit, twofold benefit, right? There's the ASP uplift you get because we will from a distributor margin to a direct sell. And on the -- and then you get the same focus benefit we're going to get in the U.K. And I think based on how things were going between the U.K. and France, there's more upside in France on volume as well because it was -- relative U.K.'s lower penetration of IVL in coronary. And again, almost very little penetration of IVL and peripheral. So I think as we look at '22, we'll get good contribution year-on-year from U.K. and France. It will be a volume and an ASP contribution. And that won't be done in '22. There's a lot of opportunity there. And I'm really proud and impressed with the team just coming out of the gate strong and their ability to start driving activity and awareness of IVL beyond where it was.

在法國，有一個好處，雙重好處，對嗎？你會得到平均售價的提升，因為我們將從分銷商利潤轉向直銷。然後你會得到我們將在英國獲得的同樣的重點優勢。我認為，根據英國和法國之間的情況，法國的銷量也有更多的上行空間，因為它是 - - 相對英國，IVL 在冠狀動脈中的滲透率較低。再次強調，IVL 和外周的滲透幾乎很少。因此，我認為，當我們展望 22 年時，我們將從英國和法國獲得同比良好的貢獻。這將是一個捲和一個 ASP 貢獻。這不會在 22 年完成。那裡有很多機會。我對剛剛走出大門的團隊以及他們開始推動 IVL 活動和 IVL 意識超越原來水平的能力感到非常自豪和印象深刻。

And then in terms of '23 for Asia, we're -- certainly, we have our internal modeling that we have a range of possible outcomes, which are also influenced by when we get approved and what our reimbursement level looks like in Japan. We see this year very much -- one of the key activities this year is really to set ourselves up for Asia to become one of our growth drivers next year. We're not -- whatever we get this year is great, but we want to make sure what we do this year is more of an eye towards 2023, 2024 significant contribution.

然後就亞洲的“23”而言，我們當然有內部模型，我們有一系列可能的結果，這些結果也受到我們何時獲得批准以及我們在日本的報銷水平的影響。我們對今年非常看重——今年的關鍵活動之一確實是讓亞洲成為我們明年的增長動力之一。我們今年所做的一切都不是很好，但我們希望確保今年所做的更多是著眼於 2023 年、2024 年的重大貢獻。

And so we're -- obviously, we're not guiding to 2023, but we have -- given that Japan has 250,000 PCIs, which is about 1/4 of the U.S. market, a very high percentage of imaging, a very, very significant reluctance to do anything that causes adverse events more than any other country that I have sold into. It's like the perfect country for ShockWave sort of the fit in terms of the safety, ease of use and identification of calcium. So we're quite optimistic about the role that ShockWave will play in Japan. And last I heard, China was a pretty big country with a lot of patients and 1.5 million PCIs so that should be a nice opportunity for us, too.

所以我們 - 顯然，我們不會指導到 2023 年，但我們已經 - 考慮到日本有 250,000 個 PCI，大約占美國市場的 1/4，成像比例非常高，非常，與我銷售過的任何其他國家相比，我非常不願意做任何會導致不良事件的事情。在鈣的安全性、易用性和識別方面，它就像是 ShockWave 的完美國家。所以我們對ShockWave 在日本扮演的角色相當樂觀。最後我聽說，中國是一個相當大的國家，有很多患者和 150 萬例 PCI，所以這對我們來說也應該是一個很好的機會。

Yes. Maybe I'll just throw a little more color on that. One thing about Japan, if you look at the CAD IV data set, it was the cleanest acute 30-day data set we've seen of any of the CAD trials. I mean they just excellent PCI operators. And it's -- they really value safety and predictability in their practices. So that is favorable for IVL generally. I think the other thing that our leadership team in Japan has done and our General Manager, particularly has really worked closely with the society, the cardiovascular society in Japan, CVIT, to help create together with the cardiovascular leadership in Japan, how is the -- what is the appropriate way to roll this product out.

是的。也許我會對此多加一點色彩。關於日本的一件事是，如果您查看 CAD IV 數據集，您會發現它是我們所見過的所有 CAD 試驗中最乾淨的急性 30 天數據集。我的意思是他們只是優秀的 PCI 運營商。他們確實非常重視實踐中的安全性和可預測性。因此，這總體上有利於 IVL。我認為我們在日本的領導團隊所做的另一件事，特別是我們的總經理，與社會、日本心血管學會、CVIT 密切合作，幫助與日本心血管領導層共同創建，情況如何—— - 推出該產品的適當方式是什麼？

So there's been 18 months of commercial preparation on how to roll this product out in Japan. And -- so I think we'll be ready and we'll do that in conjunction with all the leadership -- cardiovascular leadership in Japan, and that should help.

因此，為了在日本推出該產品，我們進行了 18 個月的商業準備。所以我認為我們會做好準備，我們將與日本心血管領導層的所有領導層一起做到這一點，這應該會有所幫助。

And one of the thing about China -- one of the reasons we like the JV aspect in China is instead of just importing product to a distributor, we're importing product to a JV. And that helps us drive focus. And as you -- as we saw with the unit volume uplift in the U.K. and France, and if we can get focus through a distributor and in China, it's through a JV, which really helps us keep focus on the product, I think we'll do a really nice job in China relative to kind of a typical distribution arrangement.

關於中國的一件事——我們喜歡中國合資企業的原因之一是，我們不只是向經銷商進口產品，而是向合資企業進口產品。這有助於我們集中註意力。正如我們在英國和法國看到的單位銷量的增長，如果我們可以通過經銷商和在中國獲得關注，那就是通過合資企業，這確實有助於我們保持對產品的關注，我認為我們相對於典型的分銷安排，在中國會做得非常好。

And I'm not showing any further questions at this time. So ladies and gentlemen, this does conclude today's presentation. You may now disconnect, and have a wonderful day.

目前我不會提出任何進一步的問題。女士們、先生們，今天的演講到此結束。您現在可以斷開連接，並度過美好的一天。