Revance Therapeutics Inc (RVNC) 2022 Q4 法說會逐字稿

Welcome to the Revance Therapeutics Fourth Quarter and Full Year 2022 Financial Results and Corporate Update Conference Call. (Operator Instructions) As a reminder, this call is being recorded today, Tuesday, February 28, 2023.

歡迎來到 Revance Therapeutics 第四季度和2022年全年財務業績和公司更新電話會議。 （操作員說明）提醒一下，今天，即 2023 年 2 月 28 日，星期二，正在錄製此電話。

I would now like to turn the conference over to Jessica Serra, Head of Investor Relations and ESG for Revance. Please go ahead.

我現在想把會議轉交給 Revance 的投資者關係和 ESG 主管 Jessica Serra。請繼續。

Thank you, Jack. Joining us on the call today from Revance are Chief Executive Officer, Mark Foley; President, Dustin Sjuts; and Chief Financial Officer, Toby Schilke.

謝謝你，傑克。今天與我們一起參加 Revance 電話會議的還有首席執行官 Mark Foley； Dustin Sjuts 總裁；和首席財務官 Toby Schilke。

During this conference call, management will make forward-looking statements, including statements related to 2023 guidance, cash flow breakeven and future revenue and expenses, our value creation and growth potential, the efficacy and duration of DAXXIFY, our ability to draw on our debt, our regulatory submissions and approvals, our entry into the therapeutics market, our commercial success, consumer preferences and behavior that benefits to us, practices and consumers of our products and services, consumer outcomes, the supply and manufacturing of DAXXIFY, sales team growth and our strategy, plant operations, services strategy and commercialization plans and timing.

在本次電話會議中，管理層將做出前瞻性陳述，包括與 2023 年指導、現金流盈虧平衡和未來收入和支出、我們的價值創造和增長潛力、DAXXIFY 的功效和持續時間、我們利用債務的能力相關的陳述、我們的監管提交和批准、我們進入治療市場、我們的商業成功、消費者偏好和對我們有利的行為、我們產品和服務的實踐和消費者、消費者結果、DAXXIFY 的供應和製造、銷售團隊的成長和我們的戰略、工廠運營、服務戰略以及商業化計劃和時間安排。

Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in our Annual Report on Form 10-K filed with the SEC today, February 28, 2023. Revance undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events or changes in its expectations.

由於這些風險和不確定性，我們的實際結果和事件發生的時間可能與此類前瞻性陳述中的預期存在重大差異。可能導致結果與這些陳述不同的因素包括公司在我們於今天（2023 年 2 月 28 日）向美國證券交易委員會提交的 10-K 表格年度報告中標題為風險因素的部分中描述的因素。Revance 不承擔更新的義務或義務由於新信息、未來事件或預期變化而產生的任何前瞻性陳述。

With that, I will turn the call over to Mark Foley, Chief Executive Officer of Revance. Mark? Thank you, Jessica, and good afternoon, everyone, and thank you for joining our fourth quarter and full year 2022 financial results conference call. 2022 was a landmark year for Revance. With strong execution on our strategic priorities, we not only delivered outstanding financial results for the year, but also positioned ourselves for significant value creation going forward, highlighting our many achievements with the approval of DAXXIFY.

有了這個，我將把電話轉給 Revance 的首席執行官 Mark Foley。標記？謝謝杰西卡，大家下午好，感謝您參加我們的第四季度和 2022 年全年財務業績電話會議。 2022 年對 Revance 來說是具有里程碑意義的一年。憑藉對戰略重點的有力執行，我們不僅在本年度取得了出色的財務業績，而且為未來創造重大價值做好了準備，突出了我們在 DAXXIFY 批准下取得的諸多成就。

The approval makes DAXXIFY the first and only peptide-formulated neuromodulator with long-lasting results and the first true innovation in neuromodulator formulation in over 30 years. Moreover, the product's efficacy and median duration of 6 months has been achieved by using a similar amount of core active ingredient as that of the leading competitor. DAXXIFY's approval not only enhances our competitive positioning in the facial aesthetics market, but also lays the foundation for our entry into therapeutics.

該批准使 DAXXIFY 成為第一個也是唯一一個具有持久效果的肽配製神經調節劑，也是 30 多年來神經調節劑配方的第一個真正創新。此外，該產品的療效和 6 個月的中位持續時間是通過使用與主要競爭對手相似數量的核心活性成分實現的。 DAXXIFY 的獲批不僅提升了我們在面部美容市場的競爭地位，也為我們進入治療學領域奠定了基礎。

As previously communicated, we initiated the introduction of DAXXIFY to the aesthetics market through our planned early experience PrevU program in December. Thus far, we've been very pleased with the strong initial uptake and positive feedback from both injectors and consumers. Our strategic priority for 2022 -- our second strategic priority for 2022 was to drive the top line growth of our RHA collection of dermal fillers. Through our focused execution and with the introduction of new innovation, RHA redensity, we increased adoption, enhanced account productivity and are very pleased to report a 51% revenue increase from last year.

正如之前所傳達的那樣，我們在 12 月通過我們計劃的早期體驗 PrevU 計劃開始將 DAXXIFY 引入美學市場。到目前為止，我們對注射器和消費者的強烈初步接受和積極反饋感到非常高興。我們 2022 年的戰略重點——我們 2022 年的第二個戰略重點是推動我們的 RHA 真皮填充劑系列的收入增長。通過我們專注的執行和引入新的創新，RHA redensity，我們提高了採用率，提高了客戶生產力，並且非常高興地報告收入比去年增長了 51%。

Turning to our third strategic priority, we made meaningful progress in enhancing our customer relationships through our Services segment. Our core belief is that by complementing our products with value-added services, we can develop deeper and lasting relationships with our practice partners. Over the past few years, we've taken important steps to become an authorized payment facilitator so that the OPUL platform can support meaningful features and functionalities. Practices are currently using OPUL to process payments at competitive rates, customized checkout options through a catalog of over 7,000 SKUs and generate data insights.

談到我們的第三個戰略重點，我們在通過服務部門加強客戶關係方面取得了有意義的進展。我們的核心信念是，通過用增值服務補充我們的產品，我們可以與我們的實踐合作夥伴發展更深入和持久的關係。在過去的幾年裡，我們採取了重要步驟成為授權的支付服務商，以便 OPUL 平台能夠支持有意義的特性和功能。實踐目前正在使用 OPUL 以具有競爭力的價格處理付款，通過 7,000 多個 SKU 的目錄定制結賬選項並生成數據洞察力。

What has taken us longer than expected to get to this stage of our platform's development, which led to an impairment charge that was recorded in Q4, we are making progress, and we'll continue to develop our services offering as part of our long-term strategy to unlock additional value for our aesthetics portfolio. In Q4, we ended the year with over 5,000 accounts across our aesthetics portfolio, up from 3,000 accounts from 1 year ago.

我們花了比預期更長的時間才達到我們平台發展的這個階段，這導致了第四季度記錄的減值費用，我們正在取得進展，我們將繼續開發我們的服務產品，作為我們長期的一部分 -為我們的美學產品組合釋放附加價值的術語策略。在第四季度，我們的美容產品組合在年底擁有超過 5,000 個賬戶，高於一年前的 3,000 個賬戶。

Prudent capital allocation was our fourth priority, and I'm pleased to report that the combination of effective cash management and strategic financings have allowed us to execute on our priorities and launch DAXXIFY from a position of strength despite the challenging financial market backdrop. Finally, investing in our people and culture is always a priority for Revance, so much so that our initiatives in these areas continue to be reflected in our annual company goals for which a portion of our executive and corporate bonuses are based. To that end, we're very pleased to achieve over 100% of our diversity and inclusion on people goals, which covered talent attraction, culture assessment, [Deana] educational programs and women and leadership. We're also looking forward to publishing our second ESG report shortly.

謹慎的資本配置是我們的第四個優先事項，我很高興地報告，有效的現金管理和戰略融資的結合使我們能夠執行我們的優先事項，並在充滿挑戰的金融市場背景下從強勢地位推出 DAXXIFY。最後，投資於我們的員工和文化始終是 Revance 的優先事項，以至於我們在這些領域的舉措繼續反映在我們的年度公司目標中，我們的部分高管和公司獎金正是基於這些目標。為此，我們很高興實現超過 100% 的多元化和包容性目標，其中包括人才吸引、文化評估、[Deana] 教育計劃以及女性和領導力。我們也期待很快發布我們的第二份 ESG 報告。

In addition to all these important accomplishments and our strong financial results for the quarter and year, we continue to make progress across several areas of the business in the early months of 2023. The FDA recently accepted our sBLA for DAXXIFY for the treatment of cervical dystonia, and we were provided with a PDUFA date of August 19, 2023. This new indication, if approved, would be our first step towards unlocking DAXXIFY's potential in therapeutics. On approval, we look forward to launching an early experience program similar to the DAXXIFY and RHA PrevU programs, followed by full commercial launch in 2024. We expect to leverage these learnings to inform our launch plans and DAXXIFY pipeline strategy in therapeutics.

除了所有這些重要成就和我們在本季度和年度的強勁財務業績外，我們在 2023 年的前幾個月繼續在多個業務領域取得進展。FDA 最近接受了我們用於治療頸肌張力障礙的 DAXXIFY 的 sBLA ，我們獲得了 PDUFA 日期為 2023 年 8 月 19 日。這一新適應症如果獲得批准，將是我們釋放 DAXXIFY 在治療學方面潛力的第一步。獲得批准後，我們期待啟動類似於 DAXXIFY 和 RHA PrevU 項目的早期體驗項目，然後在 2024 年全面商業化啟動。我們希望利用這些經驗為我們的啟動計劃和 DAXXIFY 管道戰略提供信息。

On the corporate side, I'll touch on a few Board and management changes. Earlier today, we announced the appointment of Dr. Vlad Coric, Chairman and CEO of Biohaven, as an independent director with an effective date of March 1. Vlad is the seasoned pharmaceutical executive who brings a 22-plus-year track record in biotech value creation, particularly in the area of neurology. His appointment will further enhance the collective skill set of our strong and diverse Board and will help support our innovation and market expansion efforts.

在公司方面，我將談及一些董事會和管理層的變動。今天早些時候，我們宣布任命 Biohaven 董事長兼首席執行官 Vlad Coric 博士為獨立董事，生效日期為 3 月 1 日。Vlad 是一位經驗豐富的製藥業高管，在生物技術價值方面擁有超過 22 年的業績記錄創造，特別是在神經病學領域。他的任命將進一步增強我們強大而多元化的董事會的集體技能，並將有助於支持我們的創新和市場擴張工作。

Vlad's appointment also coincides with the retirement of Phil Vickers prior to the company's 2023 annual meeting. Phil has been instrumental in shaping our scientific progress over the past 8 years, and on behalf of both management and the Board, I would like to thank him for his service and wish him all the best in the future.

Vlad 的任命也恰逢 Phil Vickers 在公司 2023 年年會之前退休。過去 8 年來，Phil 一直在推動我們的科學進步，我謹代表管理層和董事會感謝他的服務，並祝愿他未來一切順利。

I'd also like to welcome Amie Krause as our Chief People Officer, effective March 13. Amie brings over 25 years of experience in human capital management and will be stepping into this critical role as Justin Ford, our Senior Vice President, Human Resources and Head of People retires. Amie will build on the great work and progress that Justin and his team have made over the past 6 years. I'd like to thank Justin for his invaluable leadership in supporting our rapid growth as a company, attracting great talent and in shaping our inclusive and diverse workplace culture.

我還要歡迎 Amie Krause 擔任我們的首席人力資源官，將於 3 月 13 日生效。Amie 帶來了超過 25 年的人力資本管理經驗，並將擔任我們的人力資源高級副總裁 Justin Ford 和人民領袖退休。 Amie 將在 Justin 和他的團隊在過去 6 年中取得的出色工作和進步的基礎上再接再厲。我要感謝賈斯汀在支持我們公司的快速發展、吸引優秀人才以及塑造我們包容和多元化的工作場所文化方面發揮的寶貴領導作用。

In summary, I'm proud of all that we were able to accomplish in 2022, setting the stage for another exciting and important year. We look forward to growing our U.S. aesthetics franchise by successfully launching DAXXIFY and driving deeper adoption of the RHA collection while also continuing to enhance our services offerings. At the same time, we are eagerly awaiting our first anticipated therapeutics approval and are actively preparing for our market entry.

總之，我為我們在 2022 年取得的所有成就感到自豪，為又一個激動人心且重要的一年奠定了基礎。我們期待通過成功推出 DAXXIFY 和推動更深入地採用 RHA 系列來發展我們的美國美學特許經營權，同時繼續增強我們的服務產品。與此同時，我們熱切等待我們的第一個預期療法批准，並積極準備我們的市場進入。

With that, I'll turn the call over to Dustin. Dustin?

有了這個，我會把電話轉給達斯汀。達斯汀？

Thank you, Mark. I'm very pleased to see the progress our entire organization has made, specifically our strong sales results underscored by our commercial strategy and our consistent execution. Starting with the RHA Collection, we saw strong demand in Q4, resulting from numerous training events in Nashville focused on the unique rheologic properties of the RHA Collection, targeted consumer activation campaigns and the benefit of RHA Redensity in further customer engagements and adoptions. These efforts were also amplified by DAXXIFY's approval and resulted in $34.8 million of revenue in Q4, up 46% from last year. For the year, total RHA sales were $107 million, up 51%.

謝謝你，馬克。我很高興看到我們整個組織取得的進步，特別是我們的商業戰略和我們始終如一的執行突顯了我們強勁的銷售業績。從 RHA 系列開始，我們在第四季度看到了強勁的需求，這是由於在納什維爾舉辦的許多培訓活動都集中在 RHA 系列的獨特流變特性、有針對性的消費者激活活動以及 RHA Redensity 在進一步的客戶參與和採用方面的好處。這些努力也因 DAXXIFY 的批准而得到加強，並在第四季度實現了 3480 萬美元的收入，比去年增長了 46%。全年，RHA 總銷售額為 1.07 億美元，增長 51%。

The RHA Collection is currently the fastest-growing HA filler brand in the competitive U.S. filler market. Our success is a function of both our targeted strategy and the uniqueness of the product. From the way it's manufactured to its performance profile, RHA offers injectors important versatility in treating a wide range of patient needs and, as a result, has become a product that can stand on its own, independent of a neuromodulator. The approval and launch of DAXXIFY will, therefore, introduce a new dynamic for the RHA Collection. We're excited to begin seeing synergies from our differentiated suite of products and services.

RHA 系列是目前在競爭激烈的美國填料市場中增長最快的 HA 填料品牌。我們的成功取決於我們的目標戰略和產品的獨特性。從其製造方式到其性能概況，RHA 為註射器提供了重要的多功能性，可以滿足廣泛的患者需求，因此，它已成為一種可以獨立存在、獨立於神經調節劑的產品。因此，DAXXIFY 的批准和推出將為 RHA 系列帶來新的活力。我們很高興開始看到我們差異化的產品和服務套件的協同效應。

We ended the quarter with over 5,000 accounts across our aesthetics portfolio. Further, our fintech platform generated $179 million of gross processing volume, or GPV, for the quarter and $665 million of GPV for the year. On the infrastructure side, our prior approval supplement for Ajinomoto Bio-Pharma Services remains on track, and we continue to anticipate potential approval in 2023. Once approved, Aji will serve as a fill/finish contract manufacturer, an important part of our supply chain, to meet the anticipated demand for DAXXIFY.

截至本季度末，我們的美學產品組合中擁有超過 5,000 個賬戶。此外，我們的金融科技平臺本季度產生了 1.79 億美元的總處理量 (GPV)，全年產生了 6.65 億美元的 GPV。在基礎設施方面，我們對 Ajinomoto Bio-Pharma Services 的事先批准補充仍在進行中，我們繼續預計 2023 年可能獲得批准。一旦獲得批准，Aji 將作為灌裝/精加工合同製造商，這是我們供應鏈的重要組成部分, 以滿足 DAXXIFY 的預期需求。

Turning to DAXXIFY. We are very pleased with the progress of our PrevU program, our early experience program, which kicked off in December and included approximately 400 practices. These select partners were extremely engaged and excited about the exclusive opportunity to be one of the first to experience DAXXIFY. After being selected to participate in PrevU, many of them leveraged the busiest time of the year for aesthetic procedures to pre-schedule injection events to capitalize on the pent-up demand for this new innovation and to accelerate the opportunity to gain real-world clinical insights. We continue to be very encouraged by the high level of engagement surrounding DAXXIFY from both the PrevU group and our broader Revance partners. And with thousands of patients treated thus far, we feel very good about the feedback we've received and are encouraged by the high interest among injectors and consumers to experience DAXXIFY.

轉向 DAXXIFY。我們對 PrevU 計劃的進展感到非常滿意，這是我們的早期體驗計劃，該計劃於 12 月啟動，包括大約 400 次實踐。這些精選的合作夥伴對成為第一批體驗 DAXXIFY 的獨家機會感到非常投入和興奮。在被選中參加 PrevU 後，他們中的許多人利用一年中美容程序最繁忙的時間來預先安排注射活動，以利用對這項新創新的被壓抑的需求，並加快獲得現實世界臨床的機會見解。 PrevU 集團和我們更廣泛的 Revance 合作夥伴圍繞 DAXXIFY 的高度參與讓我們繼續感到鼓舞。迄今為止，已有數千名患者接受了治療，我們對收到的反饋感到非常滿意，並因注射器和消費者對體驗 DAXXIFY 的高度興趣而感到鼓舞。

Since DAXXIFY is the first and only peptide stabilized neuromodulator, in addition to being the only aesthetic neuromodulator to receive U.S. approval prior to any international or therapeutic approvals, PrevU is essential in delivering on our prelaunch objectives: #1, delivering optimized outcomes for consumers by generating real-world clinical experience with DAXXIFYY; #2, enhance the injector's ability to switch patients to DAXXIFY by ensuring seamless integration into ther current practice routine. Each are core to ensuring we understand how to best meet the needs of our practice partners and to unlock the true potential for DAXXIFYY. Unique to Revance, our commercial strategy is focused on the practice and provider first.

由於 DAXXIFY 是第一個也是唯一一個肽穩定的神經調節劑，除了是唯一一個在任何國際或治療批准之前獲得美國批准的美學神經調節劑，PrevU 對於實現我們的上市前目標至關重要：#1，通過以下方式為消費者提供優化的結果使用 DAXXIFYY 生成真實世界的臨床經驗； #2，通過確保無縫集成到當前的實踐程序中，增強注射器將患者轉換為 DAXXIFY 的能力。每一項都是確保我們了解如何最好地滿足我們實踐合作夥伴的需求並釋放 DAXXIFYY 真正潛力的核心。 Revance 的獨特之處在於，我們的商業戰略首先關注實踐和供應商。

We continue to believe that these providers have the power to drive consumer choice and, ultimately, the adoption of our portfolio. There's an increasing opportunity for Revance to shape provider behavior by pursuing a stronger and deeper partnership. To do this, our goal is to break the current product commoditization with our innovation, value proposition and no advertising pricing policy, all designed to arm our partners with what they need to optimize aesthetic outcomes and, at the same time, enhance their profitability.

我們仍然相信，這些供應商有能力推動消費者選擇，並最終採用我們的產品組合。 Revance 有越來越多的機會通過尋求更強大和更深入的合作夥伴關係來塑造供應商的行為。為此，我們的目標是通過我們的創新、價值主張和無廣告定價政策打破當前的產品商品化，所有這些都旨在為我們的合作夥伴提供他們優化審美效果所需的東西，同時提高他們的盈利能力。

Picking the right partner at the right time is critical to accelerating adoption of our portfolio within the highly competitive U.S. aesthetics marketplace. With our deep versus wide strategy, we've leveraged our PrevU program, first with the RHA Collection and now with DAXXIFY. Following the completion of DAXXIFY PrevU, we expect to kick off our elite partner launch phase in late March, which focuses on a thoughtful rollout to existing customers, leveraging live training and education programs to be held at our Nashville headquarters. Over the past 2 years, we've learned that our Nashville Experience Center has been a valuable and differentiated asset for driving early product adoption, strong customer engagement and continued partnership. For this reason, Nashville remains central to our commercial strategy, and we are continuing to invest in expanding our training and education facility to support our commercialization efforts.

在正確的時間選擇正確的合作夥伴對於在競爭激烈的美國美容市場加速採用我們的產品組合至關重要。通過我們的深度與廣泛戰略，我們利用了我們的 PrevU 程序，首先是 RHA 系列，現在是 DAXXIFY。在 DAXXIFY PrevU 完成後，我們預計將在 3 月下旬啟動我們的精英合作夥伴啟動階段，重點是對現有客戶進行深思熟慮的推出，利用將在我們納什維爾總部舉辦的現場培訓和教育計劃。在過去的 2 年裡，我們了解到我們的納什維爾體驗中心一直是推動早期產品採用、強大的客戶參與和持續合作夥伴關係的寶貴和差異化資產。出於這個原因，納什維爾仍然是我們商業戰略的核心，我們將繼續投資擴大我們的培訓和教育設施，以支持我們的商業化努力。

We plan to also augment our onboarding process by evaluating virtual training options as well as a forum for sharing best practice insights. To further capitalize on our market opportunity across the aesthetics portfolio, we are on our way to adding approximately 50 additional sales roles in late Q1, early Q2 with the expectation that they will be productive by Q3. Throughout the rollout of DAXXIFY, we expect to adhere to our strategy of building meaningful partnerships with our customers by going deep into accounts versus wide in order to optimize product adoption and penetration. As you may know, there are roughly over 40,000 aesthetic practices in the U.S. and no shortage of new entrants. -- and not all accounts behave the same.

我們還計劃通過評估虛擬培訓選項以及分享最佳實踐見解的論壇來增強我們的入職流程。為了進一步利用我們在整個美學產品組合中的市場機會，我們正準備在第一季度末和第二季度初增加大約 50 個額外的銷售職位，預計他們將在第三季度發揮作用。在 DAXXIFY 的整個推出過程中，我們希望通過深入客戶而不是廣泛客戶來堅持我們與客戶建立有意義的合作夥伴關係的戰略，以優化產品採用和滲透。如您所知，美國大約有 40,000 多家美容機構，而且不乏新進入者。 -- 並非所有帳戶的行為都相同。

Past aesthetic launch experience, coupled with our learnings of the RHA Collection prove our greatest return is from targeted accounts that are willing to quickly switch patients to our product portfolio and align with our broader prestige value proposition versus the large number of accounts that focus on sampling, dabbling or primarily making decisions driven by deal of the day pricing programs. This approach aligns with our prestige strategy, optimizes our leverage and unlock our ability to scale. We are looking forward to furthering our track record of success in commercial execution with our introduction of DAXXIFY and the continued growth of our comprehensive Revance aesthetics portfolio.

過去的美學發布經驗，加上我們對 RHA 系列的了解，證明我們最大的回報來自於有針對性的客戶，這些客戶願意快速將患者轉換為我們的產品組合，並與我們更廣泛的聲望價值主張相一致，而不是大量專注於抽樣的客戶，涉足或主要由每日交易定價程序驅動的決策。這種方法符合我們的聲望戰略，優化了我們的影響力並釋放了我們的擴展能力。我們期待通過引入 DAXXIFY 和我們全面的 Revance 美學產品組合的持續增長，進一步鞏固我們在商業執行方面的成功記錄。

With that, I'll turn the call over to Toby to cover our fourth quarter and full year financials.

有了這個，我會把電話轉給托比來報導我們第四季度和全年的財務狀況。

Thank you, Dustin. Total revenue for the fourth quarter 2022 was $49.9 million, representing a 92% increase from the same period last year due to increased sales of the RHA Collection and sales of DAXXIFY during the PrevU program. Total revenue for the full year 2022 was $132.6 million, representing a 70% increase from the same period last year, primarily due to higher RHA Collection sales. Revenue for the fourth quarter included $34.8 million of RHA Collection revenue, $11 million of DAXXIFY revenue, $2.9 million of service revenue and $1.2 million of collaboration revenue.

謝謝你，達斯汀。 2022年第四季度的總收入為4990萬美元，較去年同期增長92%，這是由於在 PrevU 計劃期間 RHA Collection 和 DAXXIFY 的銷售額增加。 2022 年全年總收入為 1.326 億美元，比去年同期增長 70%，這主要是由於 RHA Collection 銷售額的增加。第四季度的收入包括 3480 萬美元的 RHA Collection 收入、1100 萬美元的 DAXXIFY 收入、290 萬美元的服務收入和 120 萬美元的合作收入。

Before I cover our operating expenses, I'd like to take note of a few items on our cost of product revenue. Recall, in accordance with GAAP that we have been expensing manufacturing costs related to DAXXIFY as a [period] R&D item until the product was approved. When our prior approval inventory is used, we expect our cost of product revenue for DAXXIFY to increase. In addition, our cost of product revenue for the fourth quarter reflected an increase in the purchase price of the RHA Collection associated with a onetime charge for 2022 and other manufacturing, royalty and distribution costs related to DAXXIFY.

在我支付我們的運營費用之前，我想記下我們產品收入成本的一些項目。回想一下，根據 GAAP，我們一直將與 DAXXIFY 相關的製造成本作為[期間]研發項目進行支出，直到產品獲得批准。當使用我們事先批准的庫存時，我們預計 DAXXIFY 的產品收入成本會增加。此外，我們第四季度的產品收入成本反映了與 2022 年一次性收費相關的 RHA 系列購買價格的上漲以及與 DAXXIFY 相關的其他製造、特許權使用費和分銷成本。

Turning to OpEx. GAAP OpEx for the fourth quarter and full year 2022 were 194.3 and $474.5 million, respectively, compared to 87.6 and $352.5 million for the same period in 2021. GAAP OpEx for the year exceeded our previously announced guidance range of $375 million to $400 million, primarily due to 2 noncash charges that were recorded in the fourth quarter. The first charge was an impairment loss to our Services segment of $69.8 million. The charge resulted from a reduction in the internal segment forecast and growth rates, driven by the performance of the Service segment and the delay in the development of certain platform features and functionalities. The analysis also reflected the decrease in current valuation of the broader payment sector. The second charge was a onetime accelerated amortization expense of $11.7 million for our legacy HintMD developed technology assets. This expense was associated with the sunsetting of the platform following the migration of customers to OPUL.

轉向運營支出。 2022 年第四季度和全年的 GAAP 運營支出分別為 194.3 和 4.745 億美元，而 2021 年同期為 87.6 和 3.525 億美元。全年的 GAAP 運營支出超過了我們先前宣布的 3.75 億美元至 4 億美元的指導範圍，主要是由於第四季度記錄的 2 項非現金費用。第一項費用是我們服務部門的減值損失 6980 萬美元。該費用是由於服務部門的業績以及某些平台特性和功能的開發延遲所導致的內部部門預測和增長率的下降。該分析還反映了更廣泛的支付行業當前估值的下降。第二筆費用是我們遺留的 HintMD 開發的技術資產的一次性加速攤銷費用 1170 萬美元。這筆費用與客戶遷移到 OPUL 後平台的停用有關。

Excluding the cost of revenue depreciation, amortization, stock-based compensation and our impairment charge, non-GAAP OpEx were $72.8 million for the fourth quarter and $267 million for the year, which was in line with the midpoint of our previously announced guidance range of $260 million to $280 million. While we recognize an impairment charge to our Services segment, we continue to believe that services offerings such as OPUL will further enhance our competitive positioning and align with our prestige market strategy.

不包括收入折舊、攤銷、基於股票的薪酬和我們的減值費用，第四季度的非美國通用會計準則運營支出為 7280 萬美元，全年為 2.67 億美元，這與我們之前宣布的指導範圍的中點一致2.6 億至 2.8 億美元。雖然我們認識到服務部門的減值費用，但我們仍然相信 OPUL 等服務產品將進一步提升我們的競爭地位，並與我們的聲望市場戰略保持一致。

Looking ahead, we expect our 2023 GAAP OpEx to be $460 million to $480 million and non-GAAP OpEx, which excludes cost of revenue, depreciation, amortization and stock-based compensation, to be $320 million to $340 million. Our 2023 non-GAAP research and development expense is expected to be $80 million to $90 million. Our guidance for non-GAAP OpEx primarily reflects increased investments in our aesthetics commercial infrastructure, including sales team expansion, DAXXIFY and RHA commercial investments and biosimilar partnership investments.

展望未來，我們預計 2023 年 GAAP 運營支出為 4.6 億美元至 4.8 億美元，非 GAAP 運營支出（不包括收入成本、折舊、攤銷和基於股票的薪酬）為 3.2 億美元至 3.4 億美元。我們 2023 年的非 GAAP 研發費用預計為 8000 萬至 9000 萬美元。我們對非 GAAP 運營支出的指導主要反映了我們對美學商業基礎設施的投資增加，包括銷售團隊擴張、DAXXIFY 和 RHA 商業投資以及生物仿製藥合作夥伴投資。

Turning to our balance sheet. We took important steps to strengthen our financial position and our flexibility over the course of the year through strategic financings. We ended Q4 with $340.7 million in cash, cash equivalents and short-term investments. As we previously indicated, with our current cash position, the committed $100 million Tranche 2 of purchasing agreement and our anticipated revenues and expenditures, we believe our U.S. aesthetics portfolio will be funded to breakeven.

轉向我們的資產負債表。在這一年裡，我們通過戰略融資採取了重要步驟來加強我們的財務狀況和靈活性。我們以 3.407 億美元的現金、現金等價物和短期投資結束了第四季度。正如我們之前指出的那樣，根據我們目前的現金狀況、承諾的 1 億美元第二批採購協議以及我們預期的收入和支出，我們相信我們的美國美學投資組合將獲得資金以實現收支平衡。

Finally, revamping shares of common stock outstanding as of February 16, 2023, were approximately 83 million with 92 million fully diluted shares, excluding the impact of convertible debt. And with that, I'll turn the call back over to Mark.

最後，截至 2023 年 2 月 16 日，已發行普通股的重組股約為 8300 萬股，其中 9200 萬股完全稀釋，不包括可轉換債務的影響。有了這個，我會把電話轉回給馬克。

Thank you, Toby. In closing, I'd like to take this opportunity to express my deep appreciation to the entire Revance organization for all their hard work and dedication in getting us to this important point in the company's history. We continue to believe that we have the potential to annually deliver at least $1 billion of revenue over time in the U.S. aesthetic market with the assets we've assembled and that DAXXIFY will be the cornerstone for our revenue growth. We look forward to another eventful year as we launch DAXXIFY into the U.S. aesthetics market and begin our journey into therapeutics.

謝謝你，托比。最後，我想藉此機會對整個 Revance 組織表示深深的感謝，感謝他們為讓我們走到公司歷史上的這一重要時刻所做的辛勤工作和奉獻。我們仍然相信，隨著時間的推移，我們有潛力利用我們收集的資產在美國美容市場每年提供至少 10 億美元的收入，DAXXIFY 將成為我們收入增長的基石。我們期待著又一個多事的一年，因為我們將 DAXXIFY 推向美國美容市場並開始我們的治療之旅。

With that, I will now open the call up for questions. Operator?

有了這個，我現在將打開問題的電話。操作員？

(Operator Instructions) David Amsellem with Piper Sandler.

（操作員說明）David Amsellem 和 Piper Sandler。

So, yes, just a couple. So, first, as you're thinking about the landscape for DAXXIFY, can you just talk about how you're thinking about the evolution of pricing, particularly to the extent that we see another entry that's the (inaudible) product? How you're thinking about that? I know you're thinking about DAXXIFY more in the prestige practice arena, maybe (inaudible) is looking at it differently. But how are you thinking about competitive dynamics, particularly pricing? So that's number one.

所以，是的，只有一對。所以，首先，當你在考慮 DAXXIFY 的前景時，你能談談你是如何考慮定價的演變的，特別是我們看到另一個條目是（聽不清）產品的程度嗎？你是怎麼想的？我知道你在聲望實踐領域更多地考慮 DAXXIFY，也許（聽不清）以不同的方式看待它。但是您如何看待競爭動態，尤其是定價？所以這是第一。

And then secondly, it might be an obvious question, but to the extent that we see sort of a bounce back at some point in the filler space, what does that mean for RHA in terms of its trajectory considering you've been at least so far fairly insulated from the headwinds. Can you talk about that?

其次，這可能是一個顯而易見的問題，但就我們在填充空間的某個點看到某種程度的反彈而言，考慮到你至少已經如此，這對 RHA 的軌跡意味著什麼遠離逆風。你能談談嗎？

Sure. So, first, on your question about evolution of pricing and as other competitors come into the market, how do we think about that interplay. We've taken a little bit of a differentiated approach from the standpoint that we've got transparent pricing. We don't find anybody to contract. They, at the time of their purchase, can decide which of the tiers they want to purchase. And we heard this from practices when we were talking to them about what would they like to see from a partnership perspective. We've done that with our RHA product line. We've also launched DAXXIFY with that same sort of pricing tier. And as a reminder, we have no advertise pricing policy. So, we're trying to find ways that we can break the commoditization of the facial injectable market and put the injector back at the center and let them have a discussion with their patient about what's the best outcome for their patient, less driven by necessarily price and more about the outcome.

當然。因此，首先，關於定價演變以及其他競爭對手進入市場的問題，我們如何看待這種相互作用。從透明定價的角度來看，我們採取了一些差異化的方法。我們找不到任何人簽約。他們在購買時可以決定要購買哪一層。當我們與他們討論他們希望從合作夥伴關係的角度看到什麼時，我們從實踐中聽到了這一點。我們已經通過 RHA 產品線做到了這一點。我們還推出了具有相同定價等級的 DAXXIFY。提醒一下，我們沒有廣告定價政策。因此，我們正在努力尋找可以打破面部注射市場商品化的方法，將注射器重新置於中心位置，讓他們與患者討論什麼是對患者最好的結果，而不是必然的驅動價格和更多關於結果。

And David, as you pointed out, we're very focused on this prestige strategy, which doesn't have to be everything to everybody. We're going after those accounts that, again, don't necessarily depend on driving patient volume solely on price and that appreciate the ability to offer premium products and differentiation. So we don't necessarily see the introduction of new competitors into the market in terms of changing our philosophy. There's already a price segment in the market that exists. And thus far, we feel like the strategy that we've taken and the ability to offer consumers with a differentiated product offering and practice as an opportunity to recapture some additional margin is the right strategy. Of course, we'll continue to be mindful of the market dynamics. But now that we also have DAXXIFY in the market, we have the ability to create some additional programs tied to our broader product portfolio. So we'll continue to evaluate that. But our strategy at launch is very similar to what we've done with the RHA product line.

大衛，正如你所指出的，我們非常關注這種聲望戰略，它不一定是每個人的一切。我們正在追查那些不一定僅僅依靠價格來推動患者數量並且欣賞提供優質產品和差異化能力的客戶。因此，就改變我們的理念而言，我們不一定會看到新的競爭對手進入市場。市場上已經存在一個價格段。到目前為止，我們認為我們採取的戰略以及為消費者提供差異化產品和實踐的能力是重新獲得一些額外利潤的機會是正確的戰略。當然，我們會繼續關注市場動態。但現在我們在市場上也有 DAXXIFY，我們有能力創建一些與我們更廣泛的產品組合相關的額外程序。因此，我們將繼續對此進行評估。但我們在發佈時的策略與我們對 RHA 產品線所做的非常相似。

In terms of the bounce back in the filler space, we continue to get asked on each call whether or not we're seeing any macroeconomic impact in our business. And thus far, we haven't. And again, we are targeted or very focused on a much smaller group of providers. And thus far, we have not seen an impact of the economy on the facial injectable usage in the accounts that we're calling on. And we continue to monitor that. Certainly, it's possible we could face that sometime in the future. But a bounce back to us, given that we're not seeing really an impact in terms of volumes in accounts, I'm not sure would have a meaningful impact on us at this point.

就填充空間的反彈而言，我們繼續在每次電話中被問及我們是否看到我們的業務受到任何宏觀經濟影響。到目前為止，我們還沒有。同樣，我們的目標是或非常關註一小部分提供者。到目前為止，我們還沒有看到經濟對我們所拜訪的賬戶中面部注射劑使用的影響。我們將繼續對此進行監控。當然，我們有可能在未來的某個時候面對這種情況。但是反彈給我們，鑑於我們沒有看到對賬戶數量的真正影響，我不確定此時會對我們產生有意義的影響。

Chris Shibutani with Goldman Sachs.

Chris Shibutani 與高盛。

This is Roger on for Chris. So, our question kind of pertains to the patient volume mix that you're seeing and anticipate in the future. You mentioned earlier that the greatest amount of value you guys are deriving is coming from practices that are willing to switch quickly as opposed to those with more capturing deal-of-the-day type events. So, as you think about the future, do you think the dynamics are going to influence that in terms of you'll be focusing more on patients for switching from BOTOX or how do you think about capturing the patients who are new starters?

這是克里斯的羅傑。因此，我們的問題與您在未來看到和預期的患者數量組合有關。您之前提到過，你們獲得的最大價值來自於願意快速轉換的實踐，而不是那些更多捕捉每日交易類型事件的實踐。因此，當您考慮未來時，您是否認為動態會影響您將更多地關注從 BOTOX 轉換的患者，或者您如何考慮吸引新手患者？

So, I think, Roger, our strategy, as we've articulated before, is really targeted at prestige segment. We set up the 40,000 accounts that we estimate in the U.S. that do facial injectables that about 1/3 of those really fit into our strategy. As of the end of Q4, we said that we're in roughly 5,000 accounts out of that, call it, 12,000 to 15,000 account level. So, we are very focused on targeting those injector accounts that we believe are aligned with our strategy. And so, ours is less about going out and trying to capture consumers with more about treating the consumers that reside in those prestige practices. We believe strongly that these leading injectors and practices heavily influence the choice that these consumers make when they come into the practices. So, the profile of consumer that we're going to end up switching over to DAXXIFY is going to be reflected in who the existing consumers are that are already within those practices.

所以，我認為，羅傑，正如我們之前闡明的那樣，我們的戰略確實是針對聲望細分市場的。我們估計在美國建立了 40,000 個進行面部注射的賬戶，其中約 1/3 真正符合我們的戰略。截至第四季度末，我們說我們大約有 5,000 個帳戶，稱之為 12,000 到 15,000 個帳戶級別。因此，我們非常專注於針對那些我們認為符合我們戰略的注射器帳戶。因此，我們的重點不是走出去並試圖吸引消費者，而是更多地對待那些享有盛譽的消費者。我們堅信，這些領先的注射器和做法會嚴重影響這些消費者在接受這些做法時做出的選擇。因此，我們最終將切換到 DAXXIFY 的消費者概況將反映在已經在這些實踐中的現有消費者是誰。

There's no doubt that any time new innovation comes into the market, it sparks and it stirs consumer interest. But we would think that the practices that provide DAXXIFY are going to end up getting a number of new patients that come in because they've heard about it. But again, our strategy is much more focused on arming these practices with all the information they need to provide a really good experience and outcome with DAXXIFY and to let consumers know that that's an option that they provide.

毫無疑問，每當新的創新進入市場時，它都會激發消費者的興趣。但我們認為，提供 DAXXIFY 的做法最終會吸引大量新患者，因為他們聽說過它。但同樣，我們的戰略更側重於為這些實踐提供他們需要的所有信息，以便通過 DAXXIFY 提供真正好的體驗和結果，並讓消費者知道這是他們提供的一種選擇。

Seamus Fernandez with Guggenheim Securities. (technical difficulty) Annabel Samimy with Stifel.

古根海姆證券公司的 Seamus Fernandez。 （技術難度）Annabel Samimy 與 Stifel。

So, I guess, going back to, I guess, the strategy of going deeper as opposed to wider, so I guess -- we've spoken in the past and you mentioned that could be a potential headwind. Do you really see that as a headwind if you're going to be going deeper in these accounts, first of all? And second then, you mentioned also that in the -- you started getting orders -- you've got orders from the 400 participants in the PrevU. Have you started seeing reorders from them? And you also mentioned maybe some other partners and people started ordering outside of this PrevU yet because of some level of desire to get ahead of the whole DAXI trend. So maybe you can just start with that.

所以，我想，我想，回到更深入而不是更廣泛的戰略，所以我想——我們過去談過，你提到這可能是一個潛在的逆風。首先，如果您要深入研究這些帳戶，您真的認為這是不利因素嗎？其次，您還提到，在您開始獲得訂單時，您已經從 PrevU 的 400 名參與者那裡獲得了訂單。您是否開始看到他們的重新訂購？你還提到，也許其他一些合作夥伴和人們開始在這個 PrevU 之外訂購，因為在某種程度上想要領先於整個 DAXI 趨勢。所以也許你可以從那開始。

Sure. The deeper versus wider strategy is something that we've been very consistent with going back to the RHA. If you look at it, the onboarding pace of new customers on the RHA fillers has been pretty consistent over time, where we've added roughly 500 new accounts per quarter, all with the goal of let's make sure that when we introduce somebody to our products that they get trained the right way, they get the right information to be successful. And that again, we can drive stickiness. And so that's been a long-term part of our prestige strategy. And so it's very consistent with what we plan to do with DAXXIFY.And as we've stated previously, we plan to target those accounts that we have an existing RHA relationship with first because we have a relationship with them. And we think any time you're introducing a new product, making sure that, that onboarding process is robust, engaged and that we are working to get it integrated into the practice versus just the sampling thing is the right strategy.

當然。更深層次與更廣泛的策略是我們一直非常支持回到 RHA 的東西。如果你看一下，新客戶在 RHA 填充器上的入職速度隨著時間的推移一直非常一致，我們每季度增加大約 500 個新客戶，所有這些都是為了確保當我們向我們的客戶介紹某人時他們以正確的方式接受培訓的產品，他們獲得了成功的正確信息。再一次，我們可以提高粘性。因此，這是我們聲望戰略的長期組成部分。因此，這與我們計劃對 DAXXIFY 所做的非常一致。正如我們之前所說，我們計劃首先針對那些與我們現有 RHA 關係的帳戶，因為我們與他們有關係。我們認為，無論何時您推出新產品，確保入職流程穩健、參與，並且我們正在努力將其整合到實踐中，而不僅僅是抽樣是正確的策略。

And so, if you look at our PrevU program, it was really designed to give us additional insights into practice integration, clinical outcome, real-world usage so that when we did go to full commercial launch, which we will kick off later this quarter towards the end of March, that we can take some of those learnings and make tweaks or modifications to the information that we share. And so, we're very pleased with how PrevU is going, the learnings that we have, and we continue to be very much on target for our overall launch plan and strategy.

因此，如果您看一下我們的 PrevU 計劃，它的真正目的是讓我們對實踐整合、臨床結果、實際使用情況有更多的了解，這樣當我們真正進入全面商業發佈時，我們將在本季度晚些時候啟動到 3 月底，我們可以吸取其中的一些經驗，並對我們共享的信息進行調整或修改。因此，我們對 PrevU 的進展情況、我們所學到的知識以及我們的整體發布計劃和戰略的目標非常滿意。

With regards to the -- and I don't know that we've ever said that that's a headwind. I just think that that's always been the strategy and fits very well in that prestige of targeting those accounts. With regards to the PrevU, as you're aware, we rolled out the PrevU program to approximately 400 accounts in December. These accounts are accounts that were very anxious and eager to get DAXXIFY, had a lot of patients ready to use the product when they brought it in. And we've certainly had a fair bit of reorders on those accounts. But it's really provided that platform for learning and education to inform the broader market launch, which we plan to roll out again in late March.

關於 - 我不知道我們是否曾經說過這是一個逆風。我只是認為這一直是策略，並且非常適合針對這些客戶的聲望。關於 PrevU，如您所知，我們在 12 月向大約 400 個帳戶推出了 PrevU 計劃。這些賬戶是非常焦慮和渴望獲得 DAXXIFY 的賬戶，有很多患者在引入該產品時準備好使用該產品。我們當然對這些賬戶進行了相當多的重新訂購。但它確實提供了學習和教育平台，為更廣泛的市場發布提供信息，我們計劃在 3 月下旬再次推出。

Great. And will you be giving us for order measures going forward?

偉大的。你會為我們提供未來的秩序措施嗎？

We haven't historically done that with RHA. We've talked more about account side of it. We're very early in that side of it. And so we'll continue to assess what we think makes sense as we have more data to inform that process. But if we look at what we've historically done, we've given the number of accounts that we have from an aesthetics portfolio standpoint. So, I think that's a good baseline. And then, as we get more information, but we're super early. We really like what we're seeing and it's very consistent with the strategy that we've mapped out. And so as we have information that we think is informative going forward, we'll look to share that.

我們以前沒有用 RHA 這樣做過。我們已經更多地討論了它的帳戶方面。我們在這方面還很早。因此，我們將繼續評估我們認為有意義的事情，因為我們將有更多數據來為該過程提供信息。但如果我們看看我們過去做過的事情，我們已經從美學投資組合的角度給出了我們擁有的賬戶數量。所以，我認為這是一個很好的基準。然後，隨著我們獲得更多信息，但我們還為時過早。我們真的很喜歡我們所看到的，它與我們制定的戰略非常一致。因此，當我們擁有我們認為對未來有用的信息時，我們將分享這些信息。

Okay. And then, 1 last question, if I can switch to therapeutics. So obviously, you're going to be approaching potential approval this year. Can you talk about some of the commercial and specifically payer efforts that you have underway on how you will be, I guess, pitching a premium product to a market that doesn't always use logic and pharmacoeconomics when they're making their access decisions. So, if you could just help us understand?

好的。然後，最後一個問題，我是否可以轉向治療學。很明顯，你今年將接近潛在的批准。你能談談你正在進行的一些商業和特別是付款人的努力嗎？我想，將優質產品推向一個在做出准入決定時並不總是使用邏輯和藥物經濟學的市場。所以，如果你能幫助我們理解？

Sure. So, absolutely. Yes. We tried to cover some of that in our prepared comments. So with our PDUFA date in August this year, our hope is that we'll get approved on our PDUFA date, and we will launch something very similar to the PrevU program that we've done with RHA and with DAXXIFY, all with this goal of trying to really figure out what's going to be the best way to drive depth and penetration. And this will give us an opportunity to engage with payers. It will give us an opportunity to get a lot of real-world clinical use. Obviously, there's a compelling value proposition to be made with a longer-lasting toxin in these debilitating conditions. And we think this collective body of information will help inform the details of our go-to-market strategy and, probably more importantly, even our pipeline strategy in terms of what other trials do we invest in from an indication expansion. And so, we'll learn a lot through our PrevU phase later this year, assuming approval, and then we'll use that to inform our 2024 commercial launch strategy.

當然。所以，絕對。是的。我們試圖在準備好的評論中涵蓋其中的一些內容。因此，隨著我們今年 8 月的 PDUFA 日期，我們希望我們能在 PDUFA 日期獲得批准，並且我們將推出與我們與 RHA 和 DAXXIFY 一起完成的 PrevU 計劃非常相似的東西，所有這些都是為了這個目標試圖真正弄清楚什麼是推動深度和滲透的最佳方式。這將使我們有機會與付款人互動。這將使我們有機會獲得大量真實世界的臨床應用。顯然，在這些令人虛弱的條件下，使用更持久的毒素具有令人信服的價值主張。我們認為，這一集體信息將有助於告知我們進入市場戰略的細節，甚至可能更重要的是，甚至是我們的管道戰略，即我們從適應症擴展中投資的其他試驗。因此，假設獲得批准，我們將在今年晚些時候的 PrevU 階段學到很多東西，然後我們將使用它來為我們的 2024 年商業發布戰略提供信息。

Seamus Fernandez with Guggenheim Securities.

古根海姆證券公司的 Seamus Fernandez。

Just a couple of quick questions. I was just hoping that if you might, obviously the consensus after the impressive fourth quarter uptake that I think really surprised relative to expectations, maybe it surprised you guys as well. But I wanted to just get a sense, obviously consensus numbers have risen. What is your comfort with sort of the revenue range that sits out there today? I think, given the initial uptake, there definitely is a bias to get quite excited about that early launch trajectory. Just wanted to get a better sense of how to think about, I guess, some would say, the rhythm of the numbers as we move through the balance of the year? And maybe if you could just provide a little context on the importance of really coming online and the timing of Aji coming online to the contribution to the revenue potential for DAXI this year?

只是幾個簡單的問題。我只是希望，如果你們可以的話，很明顯，在令人印象深刻的第四季度接受之後達成的共識，我認為相對於預期來說真的很驚訝，也許它也讓你們感到驚訝。但我只是想了解一下，顯然共識數字已經上升。您對今天的收入範圍感到滿意嗎？我認為，鑑於最初的接受度，肯定存在對早期發布軌跡感到非常興奮的偏見。只是想更好地了解如何思考，我猜，有些人會說，隨著我們度過一年的平衡，數字的節奏？也許您能否提供一些背景信息，說明真正上線的重要性以及 Aji 上線的時間對今年 DAXI 收入潛力的貢獻？

Yes. Thanks, Seamus. It's hard, obviously, to give guidance at this point. We're at 2 quarters -- or 2 months into our PrevU launch. And so, it's very early. But there's nothing that we've seen in the PrevU launch strategy that changes our optimism for the opportunity going forward for our strategy. And if we kind of take a step back, when we look at it, we've talked about the fact that we think with the collection of assets that we have in the aesthetics franchise, between our RHA-DAXXIFY and Services segment that we can get to $1 billion of revenue in the U.S. aesthetics market.

是的。謝謝，西默斯。顯然，此時很難給出指導。 PrevU 發布已經過去了 2 個季度或 2 個月。所以，現在還很早。但我們在 PrevU 發布戰略中沒有看到任何改變我們對未來戰略機遇的樂觀態度。如果我們退後一步，當我們審視它時，我們已經談到了一個事實，即我們認為我們在美學特許經營中擁有的資產集合，在我們的 RHA-DAXXIFY 和服務部門之間，我們可以在美國美容市場獲得 10 億美元的收入。

So, we feel very good about where we are in that journey. It's just -- it's hard to give any guidance right now given that we are so early in this journey. What I will tell you is that we have a significant number of accounts who are very interested in getting trained and getting onboarded with DAXXIFY. We know that they have, within those practices, a number of consumers who are very interested in getting DAXXIFY treatment. And that's before we've really amplified the awareness that's out there. So we feel like we're very well positioned in the PrevU program. We've been encouraged by the learnings that we've had and the experience that we've seen from both the injectors and from the consumers. So, I just think it's a little early for us to give any commentary about how we feel about guidance given where we are in that phase.

因此，我們對自己在這段旅程中所處的位置感到非常滿意。只是 - 鑑於我們在這個旅程中還處於早期階段，現在很難給出任何指導。我要告訴您的是，我們有大量客戶非常有興趣接受培訓並開始使用 DAXXIFY。我們知道，在這些實踐中，他們有許多對獲得 DAXXIFY 治療非常感興趣的消費者。那是在我們真正增強人們的意識之前。所以我們覺得我們在 PrevU 計劃中處於非常有利的位置。我們從注射器和消費者那裡學到的知識和經驗讓我們深受鼓舞。所以，我認為現在就我們所處階段的指導意見發表任何評論還為時過早。

On the Aji side, we've long talked about what our supply chain strategy is. Newer California, where we make both our drug substance and limited drug product, we said is not configured to meet the expected demand of DAXXIFY. So we early on signed a partnership with Ajinomoto down in San Diego as a fill/finish contract manufacturer. The post-approval supplement was filed in 2022. We feel very good about where we are in that process and approval in 2023. They have been making product all along the journey prior to their approval. We do need them to come online in 2023, but we feel very good about where they are in that process today.

在 Aji 方面，我們一直在談論我們的供應鏈戰略是什麼。新加利福尼亞州，我們在那裡生產我們的原料藥和有限的藥物產品，我們說配置不滿足 DAXXIFY 的預期需求。因此，我們很早就與位於聖地亞哥的 Ajinomoto 簽署了合作夥伴關係，作為填充/表面處理合同製造商。批准後補充文件於 2022 年提交。我們對我們在該過程中所處的位置和 2023 年的批准感到非常滿意。他們在批准之前的整個過程中一直在生產產品。我們確實需要它們在 2023 年上線，但我們對它們今天在該過程中所處的位置感到非常滿意。

We've also signed an agreement with lyophilization services of New England because we believe that in order to meet the longer-term demand that we're going to need them to come online as well. And so, we need them to come online in 2025, and we continue to be encouraged by the progress that they're making. So, we feel very good about where we're positioned right now. We've got a fair bit of inventory that we built in advance of our approval in the new work site, and we also feel good about where Aji is in terms of their process as well.

我們還與新英格蘭的凍乾服務簽署了一項協議，因為我們相信，為了滿足長期需求，我們也需要他們上線。因此，我們需要它們在 2025 年上線，我們繼續為他們所取得的進步感到鼓舞。所以，我們對我們現在的定位感覺非常好。我們在新工作地點獲得批准之前已經建立了相當多的庫存，我們也對 Aji 在他們的流程方面所處的位置感到滿意。

Great. And if I could just ask a follow-up question, if you don't mind, could you just provide maybe a little bit of color on where the ASP is and sort of the unit-to-unit match up relative to BOTOX and -- or at least where it was in the fourth quarter? And if you can continue to provide updates with regard to where the ASP sits on a relative basis going forward?

偉大的。如果我可以問一個後續問題，如果你不介意的話，你能不能提供一點顏色說明 ASP 的位置以及相對於 BOTOX 的單位對單位匹配以及 - - 或者至少是第四季度的情況？您是否可以繼續提供有關 ASP 未來相對位置的更新信息？

Sure. So, maybe I'll start with the second part, the unit to unit. So, on the unit to unit side, if you look at our labeled indication for glabellar line treatment, it's 40 units of DAXI in the glabella, which is the indicated dose. And that has a core amount of active neurotoxin of 0.18 nanograms. And if you compare that to, example, for BOTOX, their labeled indication for glabellar lines is 20 units, which also has 0.18 nanograms. And so, what we have seen in practices is that they are looking to deliver basically the same amount of core neurotoxin that they're used to with other neuromodulators. And so, if you compare it again to the market leader, we're about a 2-to-1.

當然。所以，也許我將從第二部分開始，逐個單元。因此，在單位到單位方面，如果您查看我們標記的眉間線治療適應症，眉間有 40 個 DAXI 單位，這是指示劑量。它的核心活性神經毒素含量為 0.18 毫微克。如果將其與 BOTOX 進行比較，眉間紋的標記指示為 20 個單位，也有 0.18 毫微克。因此，我們在實踐中看到的是，他們正在尋求提供與其他神經調節劑基本相同數量的核心神經毒素。因此，如果您再次將其與市場領導者進行比較，我們大約是 2 比 1。

If you look at our pricing of 2 vials to every 1 vial of the market leader, we believe our pricing probably to the practice comes in at anywhere from maybe a 10% premium to a 40% premium depending on where they are, or 2 vials to their 1 vial. And that depends on what they buy for and what level they buy. We've got 4 different levels that practices can buy at with our product, and it has to do with the volume that they purchase at any given point in time. And so, our internal ASP will fluctuate based on the mix of how these practices buy. But it's the same pricing for everybody based on how they choose to buy. And again, that volume purchase is going to vary probably on a quarterly basis.

如果您查看我們對市場領導者每 1 瓶 2 瓶的定價，我們相信我們的定價可能會從 10% 到 40% 的溢價不等，具體取決於它們所在的位置，或 2 瓶到他們的 1 小瓶。這取決於他們購買什麼以及他們購買的級別。我們有 4 個不同的級別，實踐可以購買我們的產品，這與他們在任何給定時間點購買的數量有關。因此，我們的內部 ASP 將根據這些做法的購買方式而波動。但根據他們選擇購買的方式，每個人的定價都是一樣的。同樣，批量購買可能會按季度變化。

Okay. Great. Maybe if I could just ask one final question. As we think about the sort of opportunity in therapeutics, how do you expect sort of the launch in therapeutics to compare to the launch in aesthetics? I presume it will be 1quite a bit slower, a little bit more paced than aesthetics, but just wanted to get maybe a little bit of color on how you're thinking about the uptake in the therapeutics market. And I'll jump back in the queue.

好的。偉大的。也許我可以問最後一個問題。當我們考慮治療學的機會時，您如何看待治療學的推出與美學的推出相比？我認為它會比美學慢一點，節奏快一點，但只是想了解一下您如何考慮治療市場的吸收。我會跳回到隊列中。

Sure. I've got Dustin here with me. Maybe I'll throw that one over to him.

當然。我有達斯汀和我一起。也許我會把那個扔給他。

Yes. I think there'll be a lot of similarities in terms of how we look at learning from our providers in that space and ensuring that we have the key opinion leaders aligned with key clinical insights. So like with cervical dystonia, we will have a PrevU launch period, which will allow KOLs to kind of hone in on what is that retreatment interval that they'd like to bring back that cervical dystonia patient. As you know, with that disease state, there's a variety of disease progressions that also participate in different units, different -- excuse me, different dosages, different treatment intervals, and I think we'll use our PrevU strategy similarly in cervical dystonia to kind of leverage those.

是的。我認為，在我們如何看待向該領域的提供者學習以及確保我們擁有與關鍵臨床見解保持一致的關鍵意見領袖方面，會有很多相似之處。因此，就像頸椎肌張力障礙一樣，我們將有一個 PrevU 啟動期，這將使 KOL 能夠了解他們希望讓頸椎肌張力障礙患者恢復的再治療間隔是多少。如您所知，對於這種疾病狀態，有多種疾病進展也參與不同的單位，不同的 - 對不起，不同的劑量，不同的治療間隔，我認為我們將類似地使用我們的 PrevU 策略治療頸肌張力障礙有點影響那些。

I think what's unique about, obviously, therapeutics, but specifically cervical dystonia is obviously the use is fairly concentrated, right? So we'll be able to get it in the hands of the KOLs early in PrevU, build that data set that's required to continue to kind of increase the confidence in the larger population. And with cervical dystonia, 1,000 CD injectors really make up nearly 70% of the overall volume. So it's highly concentrated and we'll focus on those areas first with our deep strategy as well.

我認為很明顯，治療學有什麼獨特之處，但特別是頸椎肌張力障礙顯然使用相當集中，對吧？因此，我們將能夠在 PrevU 的早期將其交到 KOL 手中，構建繼續增加對更大人群的信心所需的數據集。而對於頸椎肌張力障礙，1000 個 CD 注射器確實佔了總體積的近 70%。所以它高度集中，我們也將首先通過我們的深度戰略關注這些領域。

Stacy Ku with Cowen.

Stacy Ku 和 Cowen。

Congratulations on the progress. So, our first question is around the very early any anecdotal feedback. We understand it's very early, but we appreciate any commentary from the PrevU program clinicians. We know it's still early for longevity, but any specific commentary on the onset of efficacy or aesthetic feel. Appreciate some details? And then for the second question, we're wondering if you could add any additional details regarding the pacing on how you get to each level of aesthetic accounts, maybe provide some timing or metrics around how you expand focus from the 5,000 accounts to the target 10,000 to 15,000 potential aesthetic accounts? What are the logistics as you move through the initial bolus of demand?

祝賀你的進步。因此，我們的第一個問題是圍繞早期的任何軼事反饋。我們知道現在還為時過早，但我們感謝 PrevU 計劃臨床醫生的任何評論。我們知道現在還為時過早，但對療效或美感的開始有任何具體評論。欣賞一些細節？然後對於第二個問題，我們想知道你是否可以添加任何關於你如何到達每個審美賬戶級別的節奏的額外細節，也許提供一些關於你如何將重點從 5,000 個賬戶擴展到目標的時間或指標10,000 到 15,000 個潛在的審美賬戶？當你通過最初的需求量時，物流是什麼？

Sure. So, Stacy, on the anecdotal feedback, we've been very encouraged by what we're hearing from the injectors and from the patients. As you pointed out, we are early. We're 2 months into the PrevU program. And so it's probably early to get any duration feedback per se. But thus far, the patient response has been very consistent with what we would expect and what we've seen in the clinical trials. And given the size and the scope of our clinical trial program and some of the Phase 2 work that we've done in the area, we would expect that to be very representative of what we're seeing. And so, again, it's early, but we're encouraged and it's continued to reinforce that the strategy we've put in place is the right strategy.

當然。所以，Stacy，關於軼事反饋，我們對從注射器和患者那裡聽到的消息感到非常鼓舞。正如您所指出的，我們來得早。我們已經進入 PrevU 計劃 2 個月了。因此，現在獲得任何持續時間反饋本身可能還為時過早。但到目前為止，患者的反應與我們的預期以及我們在臨床試驗中看到的非常一致。考慮到我們臨床試驗計劃的規模和範圍以及我們在該地區所做的一些第 2 階段工作，我們預計這將非常能代表我們所看到的情況。因此，再一次，現在還為時過早，但我們感到鼓舞，並且繼續強化我們實施的戰略是正確的戰略。

In terms of the pacing and the timing and the metrics, we're going to be a little bit more cautious in terms of what we share for competitive purposes. As you can imagine, it's a very competitive market that is out there. But what we did say is, we would go into this PrevU program for a quarter and then we would initiate our full commercial launch. And so, we do expect to kick that off in late March. And as we've talked previously, we do think that there's a better experience or onboarding process that we can deliver here in our Nashville headquarters. And so, we're going to have a bias and an affinity to drive people into Nashville as we think that that's going to yield more stickiness over time. And so, that process will start this quarter.

在節奏、時間和指標方面，我們將在出於競爭目的共享內容時更加謹慎。可以想像，這是一個競爭非常激烈的市場。但我們確實說過，我們將進入這個 PrevU 計劃一個季度，然後我們將啟動我們的全面商業發布。因此，我們確實希望在 3 月下旬開始。正如我們之前所說，我們確實認為我們可以在納什維爾總部提供更好的體驗或入職流程。因此，我們將有一種偏見和親和力來驅使人們進入納什維爾，因為我們認為這會隨著時間的推移產生更多的粘性。因此，該過程將從本季度開始。

And then, I think as we get into kind of our Q1 earnings, we'll be able to give a little bit more information as we'll have a bigger body of evidence. But at this time, we're not going to get into any more specifics around the timing and the metrics other than to say that we're tracking as planned and as we previously communicated and that we're going to kick off our full commercial launch with a bias towards those RHA customers starting in late March with the training here in Nashville.

然後，我認為當我們進入第一季度收益時，我們將能夠提供更多信息，因為我們將擁有更多證據。但此時，我們不會就時間和指標詳細說明，只是說我們正在按計劃進行跟踪，正如我們之前溝通的那樣，我們將開始我們的全面商業活動從 3 月下旬開始在納什維爾進行培訓，偏向那些 RHA 客戶。

Balaji Prasad with Barclays.

Balaji Prasad 與巴克萊銀行。

A couple from me. Firstly, with regard to the guidance, can you help me understand if you still have limited visibility to provide guidance at least on the filler side. I thought we would see some color around there, and maybe your account penetration expectations for DAXI for the year, one. Two, with regard to the sales force hire, I mean, we know last year that widespread challenges across industries to hire labor, do you still see those challenges? And if so, does it mean that you're paying more than the current market prices for these hires? If so, that could help explain some of the OpEx for this year, which seems to be higher than what we had expected earlier.

我的一對。首先，關於指導，你能否幫助我理解你是否至少在填充方面提供指導的能見度有限。我想我們會在那裡看到一些顏色，也許你對 DAXI 今年的賬戶滲透率預期，一個。第二，關於銷售人員的招聘，我的意思是，我們去年知道各行業在招聘勞動力方面普遍存在挑戰，您是否仍然看到這些挑戰？如果是這樣，這是否意味著您為這些僱員支付的費用高於當前市場價格？如果是這樣，這可能有助於解釋今年的部分運營支出，這似乎高於我們之前的預期。

Sure. So I'll take the first one and then maybe I'll kick the second one over to Dustin to talk about the sales force hire and then maybe even Toby on some of the OpEx and what's underpinning that. But on the guidance for the fillers, and listen, we hear you that we're about 2 years into our filler launch and that we certainly have a lot more visibility. We've been onboarding about 500 accounts a quarter. And so, we've been very pleased with the traction and the growth that we've seen in that market, taking into account seasonality. I think the challenge that we have is we know that DAXXIFY is going to introduce yet another new dynamic when the reps were only selling RHA was much easier to estimate and forecast what we thought additional growth might look like. But now those same reps are going to circle back and they're going to be the ones that will be introducing DAXXIFY into those accounts.

當然。所以我會接受第一個，然後也許我會把第二個踢給達斯汀來談論銷售人員的聘用，然後甚至可能是托比的一些 OpEx 以及支撐它的東西。但是關於填充劑的指導，聽著，我們聽到你說我們的填充劑發布已經有 2 年了，我們當然有更多的知名度。我們每個季度都在加入大約 500 個帳戶。因此，考慮到季節性因素，我們對該市場的牽引力和增長感到非常滿意。我認為我們面臨的挑戰是我們知道 DAXXIFY 將在銷售代表只銷售 RHA 時引入另一種新動力，這更容易估計和預測我們認為額外增長可能是什麼樣子。但現在那些相同的代表將轉回，他們將成為將 DAXXIFY 引入這些賬戶的人。

And so, in the near term, we may -- although we're not sure, we may see a slowdown in new account adds, for example. However, there's certainly also some accounts that we've not been successful in getting a foothold in, but DAXXIFY might open that door. So we might see some of that as well. And we have roughly 50 new salespeople that we're going to be adding in Q2 that we expect to be fully up and running by Q3. And so, we have a couple of crosscurrents this year that's just really hard for us to know exactly what we think that, that RHA profile is going to look like. But again, at the up level, we feel very good about our ability to grow RHA this year. We feel very good about our ability to launch DAXXIFY into the market. We believe we've got the right strategy. And as I mentioned earlier, we believe that we can drive our U.S. aesthetics franchise with the products and services that we have to over $1 billion in revenue over time on an annual basis.

因此，在短期內，我們可能 - 儘管我們不確定，但我們可能會看到新帳戶添加速度放緩，例如。然而，當然也有一些我們未能成功立足的賬戶，但 DAXXIFY 可能會打開這扇門。所以我們也可能會看到其中的一些。我們將在第二季度增加大約 50 名新銷售人員，我們預計將在第三季度全面啟動並運行。因此，今年我們有一些橫流，我們真的很難確切地知道我們的想法，即 RHA 概況會是什麼樣子。但同樣，在上層，我們對今年增長 RHA 的能力感到非常滿意。我們對我們將 DAXXIFY 推向市場的能力感到非常滿意。我們相信我們的戰略是正確的。正如我之前提到的，我們相信我們可以通過產品和服務推動我們的美國美學特許經營權，隨著時間的推移，我們每年的收入將超過 10 億美元。

Dustin, why don't you comment on the hiring process?

達斯汀，你為什麼不評論一下招聘過程？

Yes. Thanks, Mark. And if we look back at kind of the hiring we've had to do in the past, right, 2 years ago, we were hiring a large sales force for a new product, a dermal filler in the middle of COVID without kind of a track record for success, commercial execution, so a new entrant into the market. We're successfully able to hire that and recruit the individuals that were able to deliver outstanding results in the past 2 years. And now, we're in a very different situation with the approval of DAXXIFY, the progression of our Services strategy, alongside the success of RHA, we have been very, very pleased with the talent that is coming in for the kind of the hiring both for the managers as well as the hiring events for the sales force. We've been excited about those that have had experience in the space as well as those outside that are encouraged about the opportunity we have in front of us. And from a compensation perspective, we are at market rates. We haven't had to, as you mentioned, significantly increase the package based off of the environment. We obviously have competitive rates with the market.

是的。謝謝，馬克。如果我們回顧一下過去我們必須做的招聘工作，對吧，2 年前，我們正在為一種新產品招聘大量銷售人員，一種在 COVID 中間使用的真皮填充劑，沒有一種成功的記錄，商業執行，所以一個新進入市場的人。我們成功地能夠聘用並招募到能夠在過去 2 年中取得出色成果的個人。現在，隨著 DAXXIFY 的批准、我們服務戰略的進展以及 RHA 的成功，我們處於非常不同的境地，我們對即將到來的招聘人才感到非常非常滿意既適用於經理，也適用於銷售人員的招聘活動。我們對那些在這個領域有經驗的人以及那些對我們面前的機會感到鼓舞的人感到興奮。從薪酬的角度來看，我們按市場價格計算。正如您所提到的，我們不必根據環境顯著增加軟件包。我們顯然在市場上有競爭力的價格。

So, I don't know, Mark, if you want to turn it over to Toby on the OpEx side?

所以，我不知道，馬克，你是否想把它交給運營支出方面的托比？

Yes. Toby?

是的。托比？

Sure thing. As we talked about during the prepared remarks, our non-GAAP OpEx was $267 million for 2022, and that was in line with the midpoint of our guidance range of $260 million to $280 million for 2022. If there is any additional compensation for the sales reps, it's earned compensation for overdelivery on their commissions. So, we feel pretty good about the guidance we gave and the delivery. And when we exceeded our GAAP OpEx, that was related to the noncash charges that we talked about in the prepared remarks.

當然可以。正如我們在準備好的評論中談到的那樣，我們 2022 年的非 GAAP 運營支出為 2.67 億美元，這符合我們 2022 年 2.6 億美元至 2.8 億美元的指導範圍的中點。如果有任何額外的銷售補償代表，它因超額交付他們的佣金而獲得補償。因此，我們對我們提供的指導和交付感到非常滿意。當我們超過我們的 GAAP 運營支出時，這與我們在準備好的評論中談到的非現金費用有關。

Yes. I mean, Balaji, as it relates to this year versus last year, we've got, obviously, therapeutic that we're starting to ramp up for -- we've got some supply chain investments that we're making. We've got the biosimilar to BOTOX. And so, we have a number of initiatives that are outside of the standard normal aesthetics operating model. But we think those are the right investments to be making at this point. We feel we're in a very good cash position to launch DAXXIFY and have the right priorities. But those are some of the things that are driving -- and certainly, sales force expansion is adding to that, but it's some of those other factors that are driving the increased spend.

是的。我的意思是，Balaji，就今年與去年的對比而言，很明顯，我們已經開始加大治療力度——我們正在進行一些供應鏈投資。我們有 BOTOX 的生物仿製藥。因此，我們有許多超出標準正常美學運營模式的舉措。但我們認為這些是目前進行的正確投資。我們覺得我們的現金狀況非常好，可以推出 DAXXIFY 並且有正確的優先事項。但這些是正在推動的一些因素——當然，銷售隊伍的擴張正在增加這一因素，但也是其他一些因素推動了支出的增加。

Tim Lugo with William Blair.

蒂姆·盧戈與威廉·布萊爾。

This is Lachlan on for Tim. I guess I was wondering if you could just elaborate on the Q4 numbers. And was that purely just the sales to the 400 accounts in Q4? Or were there any onetime events that added to that? Just trying to think about setting my expectation for sort of a run rate heading into early 2023. And then, I may have missed this in the prepared remarks, but can you just talk about the plans for hiring the therapeutic sort of field team and when you would expect to be doing that? And how big it is?

這是蒂姆的拉克蘭。我想我想知道你是否可以詳細說明第四季度的數字。這僅僅是第四季度 400 個賬戶的銷售額嗎？或者是否有任何一次性事件增加了這一點？只是想考慮設定我對 2023 年初運行率的期望。然後，我可能在準備好的發言中錯過了這一點，但你能談談僱傭治療性現場團隊的計劃以及何時你會期望這樣做嗎？它有多大？

Sure. So I'll take the first and maybe kick the second one over to Dustin. So, on the Q4 numbers, most of the DAXXIFY revenue that we generated, I think that's what you're referring to, came as a result of the 400 PrevU accounts that we onboarded in December. And that group bought the product to take advantage of what was one of the busiest times of the year, and the fact that they were going to be some of the early ones to actually get the product and, therefore, had sort of a window of time to be one of the few people in their area that had it. And so, it's hard to know given that we're only 2 months into the launch with that group to know how that's going to settle out in terms of overall usage going forward.

當然。所以我會拿第一個，也許把第二個踢給達斯汀。因此，在第四季度的數字上，我們產生的大部分 DAXXIFY 收入，我認為這就是你所指的，來自我們在 12 月加入的 400 個 PrevU 賬戶。那群人購買該產品是為了利用一年中最繁忙的時期之一，事實上他們將成為最早實際獲得該產品的人之一，因此，有一個窗口是時候成為他們所在地區為數不多的擁有它的人之一了。因此，很難知道我們與該小組一起發布僅 2 個月，就未來的整體使用情況而言，這將如何解決。

And so, I know we got a lot of questions when we did our pre-announcement in early January around, is it stocking, is this usage. It's not stocking in the traditional sense that there was no middleman or third party, it reflects what those accounts thought that they were going to be able to use in whatever time frame they thought. There are incentives in our purchasing program, where if you buy more volume at the time of purchase, you do get better pricing. So there might have been some folks that were trying to get better pricing. But it's still early. Again, I come back to -- we're very encouraged by what we're seeing in the market, but it's hard to really know with that initial 400 group how that's going to inform the behavior of the future accounts going forward.

因此，我知道我們在 1 月初發布預公告時遇到了很多問題，這是庫存嗎，這是用法嗎？這不是沒有中間人或第三方的傳統意義上的庫存，它反映了這些賬戶認為他們將能夠在他們認為的任何時間範圍內使用的東西。我們的採購計劃中有激勵措施，如果您在購買時購買更多數量，您確實可以獲得更優惠的價格。所以可能有些人試圖獲得更好的定價。但現在還早。再一次，我回到——我們對市場上看到的情況感到非常鼓舞，但很難真正知道最初的 400 組將如何影響未來賬戶的行為。

I'll take the therapeutic side. We currently have the GM of Therapeutics, the Market Access head and the Head of Marketing in place. If you look at kind of as we progress towards that PDUFA date and anticipated approval, we'll continue to expand kind of the market access efforts as well as our medical affairs efforts aligned with our PrevU strategy and look forward to kind of updating you more on the field sales, sizing and others as we get closer to that date.

我會採取治療方面。我們目前有治療學總經理、市場准入負責人和營銷負責人。如果您看到我們在 PDUFA 日期和預期批准方面取得進展，我們將繼續擴大市場准入工作以及與我們的 PrevU 戰略一致的醫療事務工作，並期待為您提供更多更新隨著日期的臨近，我們將討論現場銷售、尺碼和其他方面的問題。

Terence Flynn with Morgan Stanley.

特倫斯弗林與摩根士丹利。

Great. I guess the first one is, I'm just trying to understand the comments around the Nashville training center in terms of the second phase of the rollout here. Are you implying that there's going to be a bottleneck in terms of the number of people that you can actually bring to Nashville and flow through that site? And then, the second question was, I know in the past, you've talked a lot about it having a differentiated strategy because you have both RHA filler and that now DAXXIFY. So, any latest thoughts or color on a potential bundling strategy and how that might be rolled out over the course -- back half course of the year?

偉大的。我想第一個是，我只是想了解納什維爾培訓中心對這裡推出的第二階段的評論。你是在暗示你實際可以帶到納什維爾並流經該網站的人數會出現瓶頸嗎？然後，第二個問題是，我知道過去，你已經談論了很多關於它有差異化戰略的事情，因為你既有 RHA 填充劑，又有 DAXXIFY。那麼，關於潛在捆綁策略的任何最新想法或顏色，以及如何在課程中推出這些策略 - 回到一年中的一半？

So, Terence, on your first question around Nashville and bottleneck, I mean, we think there's a proper way to onboard accounts, which is to engage them at a deep level to make sure that we've shared all the learnings that we have from some of the folks around how they message this to patients and what they go, and we think Nashville is the right way to do that. There's no doubt that we have a limit to how many people that we can ultimately run through Nashville on any given training standpoint, but we are investing and building out more capacity here in Nashville.

所以，特倫斯，關於你關於納什維爾和瓶頸的第一個問題，我的意思是，我們認為有一種正確的方式來吸引客戶，那就是讓他們深入參與，以確保我們已經分享了我們從中獲得的所有經驗教訓一些人圍繞他們如何向患者傳達這一信息以及他們去了哪裡，我們認為納什維爾是做到這一點的正確方法。毫無疑問，從任何給定的培訓角度來看，我們最終可以通過納什維爾訓練的人數是有限的，但我們正在納什維爾投資和建設更多的能力。

And we are also going to explore virtual training options as well with a bias towards Nashville. And so, I would look at this more of a thoughtful, measured rollout versus necessarily having any bottlenecks that we don't think we can work our way through. And I think that the first phase, given that we're just kicking off the commercial launch with a focus on Nashville is the right way to go, and it's the right long-term strategy. And again, we'll continue to look at ways that we can [build] a lot more capacity here in Nashville, and then, like I said, also with the virtual training options.

我們還將探索偏向納什維爾的虛擬培訓選項。因此，我會更多地考慮這是一個深思熟慮的、有計劃的推出，而不是必然存在我們認為我們無法解決的任何瓶頸。我認為第一階段是正確的方式，因為我們剛剛開始以納什維爾為重點的商業發布，這是正確的長期戰略。再一次，我們將繼續研究我們可以在納什維爾這裡[建立]更多能力的方法，然後，就像我說的，還有虛擬培訓選項。

And as we get deeper into launch, I think the collective learnings will allow, hopefully, for more of a rapid onboarding and realize too that exposing somebody to DAXXIFY is step 1. The step 2 is the field salespeople need to schedule time to go into that practice, bring samples, set up a DAXXIFY. And so there's some logistics as well that will play into this on the back end with our sales reps and why we think it's important to add to that group. And so, we look at this less of a bottleneck and more is what we think is a very thoughtful and responsible way to onboard accounts with the goal of driving longer-term stickiness.

隨著我們更深入地啟動，我認為集體學習將有望允許更多的快速入職，並且也意識到讓某人接觸 DAXXIFY 是第一步。第二步是現場銷售人員需要安排時間進入那次練習，帶上樣品，成立了DAXXIFY。因此，還有一些後勤工作將在後端與我們的銷售代表一起發揮作用，以及為什麼我們認為加入該小組很重要。因此，我們認為這不是一個瓶頸，更多的是我們認為以推動長期粘性為目標的一種非常周到和負責任的方式來註冊賬戶。

In terms of -- now that we've got both a toxin and a filler and bundling and different things, we will, of course, look at ways over time to reward customers that lean in more with us. Right now, our strategy is very much giving accounts sort of a democratic way to buy and get best pricing whenever they purchase our product. But certainly, over time, we will look at ways to find partnerships that make sense because we do have both a toxin and the filler. And we think in the near term, having both of those will open doors for us and give us an opportunity to ask for more business, either on the toxin side or on the filler side, if, for example, we have strength in one of those areas, but not the other.

就-現在我們已經有了毒素和填充物以及捆綁和不同的東西，我們當然會隨著時間的推移尋找方法來獎勵更多地依賴我們的客戶。現在，我們的策略是為客戶提供一種民主的購買方式，並在他們購買我們的產品時獲得最優惠的價格。但可以肯定的是，隨著時間的推移，我們將研究尋找有意義的合作夥伴關係的方法，因為我們確實既有毒素又有填充劑。我們認為在短期內，擁有這兩者將為我們打開大門，讓我們有機會在毒素方面或填料方面尋求更多業務，例如，如果我們在其中一個方面有實力這些領域，而不是其他領域。

Douglas Tsao with H.C. Wainwright.

Douglas Tsao 與 H.C.溫賴特。

So, maybe as a starting point on therapeutics, Mark, should we think that the addition of Vlad Coric to the Board is a signal of renewed interest in starting a migraine program?

因此，作為治療學的起點，Mark，我們是否應該認為 Vlad Coric 加入董事會是對開始偏頭痛計劃重新產生興趣的信號？

Yes. I wouldn't overly read into it. I mean, we're looking at continuing to add expertise to the Board that we think is going to be really good for our overall business. If you look at Vlad's background and the experience that he has, he is an MD. So adding an MD to the Board makes a lot of sense. He comes out of clinical practice, and then he's got extensive experience in the overall pharma space with a focus on neurology. So, I think he can help us think through a lot of our strategy around indication expansion, go-to-market strategy in those markets and a variety. So I wouldn't overly read into it. I just think we're fortunate to have Vlad join the Board, of note too is, his wife is a dermatologist. So he also will get the aesthetic side of the business. But obviously somebody with his experience and the success that he's had in the market is going to be another important voice around the Board table, and we're excited to have him as part of the team.

是的。我不會過度閱讀它。我的意思是，我們正在考慮繼續向董事會增加我們認為對我們的整體業務非常有益的專業知識。如果您查看 Vlad 的背景和經驗，就會發現他是一名醫學博士。因此，在董事會中增加一名常務董事非常有意義。他來自臨床實踐，然後在整個製藥領域積累了豐富的經驗，重點是神經病學。所以，我認為他可以幫助我們思考很多圍繞適應症擴張的戰略，這些市場的上市戰略以及各種。所以我不會過度閱讀它。我只是認為我們很幸運 Vlad 加入了董事會，值得注意的是，他的妻子是一名皮膚科醫生。所以他也將獲得業務的審美方面。但顯然，擁有他的經驗和他在市場上取得的成功的人將成為董事會會議上的另一個重要聲音，我們很高興他能成為團隊的一員。

Yes. No. I mean, I think, his experience [would help] and is a great addition. Also on therapeutics, maybe just talk about the planned sort of rollout of [NCD]. Obviously, it's a much more concentrated market, but it sounds like you're still sort of going to go through a PrevU process. I guess, maybe talk a little bit about how it will sort of differ from -- or similar as well as differ from what you've done in aesthetics?

是的。不，我的意思是，我認為他的經驗 [會有所幫助] 並且是一個很好的補充。同樣在治療方面，也許只是談論 [NCD] 的計劃推出。顯然，這是一個更加集中的市場，但聽起來您仍然需要經歷 PrevU 流程。我想，也許可以談談它與您在美學方面所做的工作有何不同或相似以及不同之處？

Yes. This is Dustin. I'll kind of handle that a little bit. I think it's a little early to go into too many specifics on it. So I think the similarities are, it will be the key KOLs that are going to drive kind of that -- our ability to build that faculty base to educate the broader market. In terms of the setup in terms of what we'll be looking for in that disease state, you're going to be looking at retreatment intervals, right? When would they like to bring those patients back? How are they handling different patient disease states, just like they did in the clinical trial with a real-world setting, which allows us to have a little bit more freedom for the provider to do what they currently do, right? So, as you'll remember, in our clinical trials, you had specific doses that they were using, where in clinical practice, they may assess the patient. They may know that they've been on a certain toxin and now they're going to move them to DAXI so they have more freedom. And so, we'll leverage that opportunity for real-world insights to inform our broader rollout and to educate the faculty.

是的。這是達斯汀。我會稍微處理一下。我認為現在討論太多細節還為時過早。所以我認為相似之處在於，關鍵的 KOL 將推動這一點——我們建立教師基礎以教育更廣泛市場的能力。就我們將在該疾病狀態下尋找的設置而言，您將查看再治療間隔，對嗎？他們什麼時候想把那些病人帶回來？他們如何處理不同的患者疾病狀態，就像他們在真實世界環境下的臨床試驗中所做的那樣，這讓我們有更多的自由讓提供者做他們目前所做的事情，對吧？所以，你會記得，在我們的臨床試驗中，你有他們使用的特定劑量，在臨床實踐中，他們可能會評估患者。他們可能知道他們一直在服用某種毒素，現在他們要把他們轉移到 DAXI，這樣他們就有更多的自由。因此，我們將利用這個機會獲得真實世界的見解，為我們更廣泛的推廣提供信息並教育教職員工。

We have time for one final question. Serge Belanger with Needham & Company.

我們有時間問最後一個問題。 Needham & Company 的 Serge Belanger。

I guess, the first question on the DAXXIFY PrevU program. You had a great start with the initial training of 400 providers in December. Just curious if you kept that pace up through January and February. And I guess, how many providers do you expect to -- will have been trained by the time you launch late in the first quarter? And then, secondly, in terms of therapeutic indications, are there still plans to run a Phase 3 program in upper limb spasticity and when could that get underway?

我想，DAXXIFY PrevU 程序的第一個問題。您在 12 月對 400 名提供者進行了初步培訓，開局良好。只是好奇您是否在 1 月和 2 月保持這種速度。而且我想，您希望在第一季度末啟動時有多少提供商接受過培訓？然後，其次，就治療適應症而言，是否仍計劃運行上肢痙攣的第 3 階段計劃，何時可以進行？

Great, Serge. So, on the DAXXIFY PrevU program, hopefully, we didn't miscommunicate on this, but the plan all along was to run the PrevU program for a quarter with a select small group of injectors, and that's 400. So we've not added any additional accounts since we did the program in December where we onboarded the roughly 400 accounts as part of PrevU. And the whole goal there was to get experience in a very controlled setting to figure out what insights we can glean from, again, how they're positioning this with patients, how they're pricing it, how they're using the product, all those things. So there have not been any additional adds as part of the PrevU program. The full commercial launch will now commence in late March, again, with a focus on in-person [natural] training. So that will kick off now the full commercial launch. And we look forward to getting that underway in late March with a focus on our existing RHA accounts.

太好了，塞爾吉。因此，在 DAXXIFY PrevU 程序中，希望我們沒有在這方面傳達錯誤，但一直以來的計劃是使用一小部分注射器運行 PrevU 程序四分之一，即 400。所以我們沒有添加自從我們在 12 月執行該計劃以來的任何其他帳戶，作為 PrevU 的一部分，我們加入了大約 400 個帳戶。整個目標是在一個非常受控的環境中獲得經驗，以弄清楚我們可以從中收集到哪些見解，再次，他們如何對患者進行定位，他們如何定價，他們如何使用該產品，所有這些東西。因此，作為 PrevU 計劃的一部分，沒有任何額外的添加。完整的商業發布將於 3 月下旬開始，同樣，重點是面對面的 [自然] 培訓。因此，現在將開始全面的商業發布。我們期待著在 3 月下旬將重點放在我們現有的 RHA 賬戶上。

On the therapeutic indication side, we've mentioned in our prepared remarks that our goal is to use the cervical dystonia approval to build clinical experience that will help inform our future therapeutic strategy. So we think we'll learn a lot in the small number of concentrated accounts that are used to dealing with a number of these muscle movement diseases. Cervical dystonia will inform a lot around, again, what Dustin was mentioning previously, what is the patient response? How often do they bring them back? Are they seeing greater symptom relief during that time frame between when they bring them back? And how we think that plays? And based on that information, I think that will give us a lot more clarity about what other indications we want to prioritize, how aggressively we want to go after them, also the payer engagement and experience is going to influence that as well.

在治療適應症方面，我們在準備好的評論中提到，我們的目標是利用頸肌張力障礙的批准來積累臨床經驗，這將有助於為我們未來的治療策略提供信息。因此，我們認為我們將從用於處理許多這些肌肉運動疾病的少數集中賬戶中學到很多東西。宮頸肌張力障礙會影響很多，同樣，達斯汀之前提到的，患者的反應是什麼？他們多久帶一次回來？在將他們帶回來之間的這段時間裡，他們是否看到了更大的症狀緩解？我們認為它如何發揮作用？基於這些信息，我認為這將使我們更清楚地了解我們想要優先考慮的其他跡象，我們想要多積極地追求它們，以及付款人的參與和經驗也會影響這一點。

Okay. One last one. I know the focus is on the U.S. launch, but have you given any more thoughts to European plans for DAXXIFY?

好的。最後一張。我知道重點是在美國推出，但你是否對 DAXXIFY 的歐洲計劃有更多想法？

Yes. Right now, we feel like we've got more than we can bite off with the U.S. launch. It's the biggest market. We've got an established field force. We've got over 5,000 accounts. We've got relationships with. The pricing is the best in this market. And so, that's going to be our focus for now. There's no doubt that the international market opportunity provides us with additional growth opportunities as we go forward. And so, we'll be very thoughtful about how we move into some of those markets as we move our way through. So, stay tuned. But for now, and certainly for 2023, our primary focus is going to be on the U.S.

是的。現在，我們覺得在美國推出時我們已經得到了更多的東西。這是最大的市場。我們有一支固定的現場部隊。我們有超過 5,000 個帳戶。我們有關係。定價是這個市場上最好的。所以，這將是我們現在的重點。毫無疑問，隨著我們前進，國際市場機會為我們提供了額外的增長機會。因此，在我們前進的過程中，我們將非常仔細地考慮如何進入其中一些市場。所以，敬請期待。但就目前而言，當然到 2023 年，我們的主要重點將放在美國。

Go ahead, operator.

來吧，接線員。

This concludes the Revance Therapeutics' fourth quarter and full year 2022 financial results and corporate update conference call. We thank you for your participation. You may now disconnect.

Revance Therapeutics 的第四季度和 2022 年全年財務業績和公司更新電話會議到此結束。我們感謝您的參與。您現在可以斷開連接。