Revance Therapeutics Inc (RVNC) 2022 Q2 法說會逐字稿

Welcome to the Revance Therapeutics Second Quarter 2022 Financial Results and Corporate Update Conference Call. (Operator Instructions) As a reminder, this call is being recorded today, Tuesday, August 9, 2022.

歡迎來到 Revance Therapeutics 2022 年第二季度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 2022 年 8 月 9 日，星期二，此電話正在錄音。

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

我現在想將電話會議轉交給 Revance 的投資者關係和 ESG 主管 Jessica Serra。請繼續。

Thank you, Bella. 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，貝拉。今天與我們一起參加 Revance 電話會議的是首席執行官 Mark Foley；總裁，達斯汀·斯朱茨；和首席財務官 Toby Schilke。

During this conference call, management will make forward-looking statements, including statements related to the regulatory process and potential approval for DaxibotulinumtoxinA for Injection in glabellar lines and in therapeutic indications, potential indications for RHA Redensity and OPUL platform, consumer preferences, the benefits to us, practices and patients of our products and services, our financial performance, 2022 guidance, expected cash runway, strategic priorities, and capital allocation plans, our market and revenue opportunity, our potential growth and our business strategy, planned operations and commercialization plans. Our actual results and the timeliness could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties.

在本次電話會議期間，管理層將發表前瞻性聲明，包括與監管程序和大西肉毒毒素 A 注射液在眉間線和治療適應症中的潛在批准、RHA Redensity 和 OPUL 平台的潛在適應症、消費者偏好、對我們、我們的產品和服務的實踐和患者、我們的財務業績、2022 年指導、預期的現金跑道、戰略重點和資本分配計劃、我們的市場和收入機會、我們的潛在增長和我們的業務戰略、計劃的運營和商業化計劃。由於這些風險和不確定性，我們的實際結果和及時性可能與此類前瞻性陳述中的預期存在重大差異。

Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in our quarterly report on Form 10-Q filed with the SEC today, August 9, 2022. 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.

可能導致結果與這些陳述不同的因素包括公司在我們於 2022 年 8 月 9 日向美國證券交易委員會提交的 10-Q 表格季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導致的任何前瞻性陳述。

With that, I will turn the call over to Mark Foley, Chief Executive Officer of Revance. Mark?

有了這個，我將把電話轉給 Revance 的首席執行官 Mark Foley。標記？

Thank you, Jessica. Good afternoon, everyone, and thank you for joining our second quarter 2022 financial results conference call. We're very pleased with our performance in the second quarter, highlighted by our best RHA quarter-to-date and solid account growth across our fillers, and OPUL relational commerce platform. These results reflect the continued success of our launch and also the strength and resilience of the facial injectables market.

謝謝你，傑西卡。大家下午好，感謝您參加我們的 2022 年第二季度財務業績電話會議。我們對第二季度的表現感到非常滿意，這突出體現在我們迄今為止最好的 RHA 季度以及我們的灌裝機和 OPUL 關係商務平台的穩健客戶增長。這些結果反映了我們推出的持續成功以及面部注射劑市場的實力和彈性。

We also decided to announce the launch of RHA Redensity, the first and only FDA-approved dermal filler for dynamic perioral for lip lines. Redensity is the latest innovation to our RHA Collection which now includes 4 distinct pillars that meets a broad range of consumer and practice needs. As a result of the progress we've made in the first half of the year, including the re-submission and acceptance of our BLA DaxibotulinumtoxinA injection and our strong commercial traction, we look forward to our September 8 PDUFA date and the prospect of entering the new growth pace.

我們還決定宣布推出 RHA Redensity，這是第一個也是唯一一個獲得 FDA 批准的用於唇線動態口周的皮膚填充劑。 Redensity 是我們 RHA 系列的最新創新，它現在包括 4 個不同的支柱，可滿足廣泛的消費者和實踐需求。由於我們在上半年取得的進展，包括我們的 BLA DaxibotulinumtoxinA 注射液的重新提交和接受以及我們強大的商業牽引力，我們期待 9 月 8 日的 PDUFA 日期和進入的前景新的增長速度。

As a reminder, the FDA designated our BLA as a Class II resubmission which has a 6-month review period and includes a required re-inspection of our manufacturing facility. As we previously communicated, we did not intend to provide details regarding our ongoing interactions with the agency. However, it might have the information we received this morning regarding the likelihood that the agency could satisfy portfolio requests on our manufacturing inspection. Prior to our PDUFA date, we would like to provide everyone with a regulatory update, so that all investors have access to the same information.

提醒一下，FDA 將我們的 BLA 指定為 II 類重新提交，其審查期為 6 個月，包括對我們的製造設施進行必要的重新檢查。正如我們之前所傳達的，我們不打算提供有關我們與該機構正在進行的互動的詳細信息。但是，它可能有我們今天早上收到的關於該機構可能滿足我們對製造檢查的投資組合要求的信息。在我們的 PDUFA 日期之前，我們希望為每個人提供監管更新，以便所有投資者都可以訪問相同的信息。

First, I am pleased to report that the FDA completed their inspection of our manufacturing facility from July 11 to July 15. Next, the corrective and preventive actions completed in response to the 5 observations from the previous Form 483 that we received in July 2021 related to our preapproval inspection, have been reviewed by the FDA and are considered closed. Lastly, as the conclusion of the reinspection of our manufacturing facility in July, the agency provided us with The Form 483, that included 3 observations. For transparency and reference, we've included a summary of the observations in our earnings press release in Form 10-Q.

首先，我很高興地報告，FDA 於 7 月 11 日至 7 月 15 日完成了對我們製造設施的檢查。接下來，針對我們在 2021 年 7 月收到的上一份 483 表中的 5 項意見，完成了糾正和預防措施。經我們的批准前檢查，已通過 FDA 審查並被視為已關閉。最後，作為 7 月份對我們製造設施的重新檢查的結論，該機構向我們提供了 483 表，其中包括 3 項觀察結果。為了透明度和參考，我們在表格 10-Q 的收益新聞稿中包含了觀察結果的摘要。

A couple of points I would like to make about the 3 observations on Form 483 we received on July 15, 2022. First, it does not include any of the 5 observations that were outstanding from our previous Form 483 related to our pre-approval inspection. You'll recall that these observations were the focus of our resubmission and as previously stated are considered close.

關於我們在 2022 年 7 月 15 日收到的關於 483 表的 3 項意見，我想提出幾點意見。首先，它不包括我們之前的 483 表中與我們的批准前檢查有關的 5 項意見中的任何一項。 .您會記得這些觀察是我們重新提交的重點，並且如前所述被認為是接近的。

Second, we are confident in our responses which we have already provided to the FDA and I'm proud of our team for the timely turnaround. We continue to expect a decision from the agency by our PDUFA date of September 8th, which is just one month away. Obtaining approval remains our top corporate priority for 2022 and our team is prepared and eager to launch our flagship drug product once approved. As a reminder on approval, we will have the opportunity to expand our access to the $3.2 billion U.S. facial injectables market which according to the latest Decision Resources Group report includes neuromodulator sales of $1.7 billion and dermal filler sales of $1.5 billion. Further, according to the American Society of Plastic Surgeons, neuromodulators and dermal fillers remain the top 2 most performed minimally invasive aesthetic procedures.

其次，我們對我們已經向 FDA 提供的回應充滿信心，我為我們的團隊及時周轉感到自豪。我們繼續期待該機構在我們的 PDUFA 日期 9 月 8 日之前做出決定，這距離我們只有一個月的時間。獲得批准仍然是我們 2022 年的首要任務，我們的團隊已準備好並渴望在獲得批准後推出我們的旗艦藥物產品。作為批准的提醒，我們將有機會擴大我們對 32 億美元的美國面部注射劑市場的准入，根據最新的決策資源集團報告，該市場包括 17 億美元的神經調節劑銷售額和 15 億美元的真皮填充劑銷售額。此外，根據美國整形外科醫生協會的數據，神經調節劑和真皮填充劑仍然是執行次數最多的前 2 位微創美容手術。

Historically, the market has grown in high-single to low double-digits and has held up well against macroeconomic headwinds, such as the economic recession in 2008 to 2009. Even with the COVID pandemic in 2020, we saw a B-shaped recovery in the following year when practices reopened. Over the mid to long term, the U.S. market is expected to grow at a compound annual growth rate of 8% to $4.7 billion by 2026.

從歷史上看，市場一直以高個位數到低兩位數增長，並且很好地抵禦了宏觀經濟逆風，例如 2008 年至 2009 年的經濟衰退。即使在 2020 年發生 COVID 大流行，我們也看到了 B 型複蘇次年，實踐重新開放。從中長期來看，預計到 2026 年，美國市場將以 8% 的複合年增長率增長至 47 億美元。

Given the current economic environment and questions surrounding its potential impact on facial injectables market, I'd like to make a few comments.

鑑於當前的經濟環境以及圍繞其對面部注射劑市場的潛在影響的問題，我想發表一些評論。

Today, based on the accounts that we are calling on, we haven't seen an impact on activity that would be beyond typical seasonality trends. You'll recall that the second and fourth quarters are usually the busiest times of the year for procedures compared to the first and third quarters. However, should macroeconomic factors begin to impact consumer spending in our target accounts, we take comfort in the resilience of the facial injectables market prior downturns, and more importantly, our unique re-positioned in the market versus other manufacturers.

今天，根據我們呼籲的賬戶，我們沒有看到對活動的影響超出典型的季節性趨勢。您會記得，與第一季度和第三季度相比，第二季度和第四季度通常是一年中程序最繁忙的時間。然而，如果宏觀經濟因素開始影響我們目標賬戶中的消費者支出，我們對面部注射劑市場在低迷之前的彈性感到欣慰，更重要的是，我們在市場上的獨特重新定位與其他製造商相比。

First, we are still in our launch phase with RHA Collection. Second, we are bringing new innovations to the market, including today's launch of RHA Redensity and the launch of our next-generation neuromodulator approved. And third, we have a differentiated go-to-market strategy that is focused on the prestige segment.

首先，我們仍處於 RHA Collection 的發布階段。其次，我們正在為市場帶來新的創新，包括今天推出的 RHA Redensity 和我們批准的下一代神經調節劑的推出。第三，我們有一個專注於高端市場的差異化市場戰略。

Now let me turn to therapeutics. The approval of DaxibotulinumtoxinA for Injection for glabellar lines will allow us to unlock opportunity in muscle movement disorders. We have a strong pipeline in this category with our completed Phase 3 program for cervical dystonia and our completed Phase 2 program for upper limb spasticity. The clinical data in both of these programs demonstrated DaxibotulinumtoxinA for Injection efficacy and median duration of effect of up to 24 weeks. We will be ready to file supplemental BLA for cervical dystonia shortly after the FDA's approval of our long-acting neuromodulator in glabellar lines.

現在讓我談談治療。 DaxibotulinumtoxinA 用於眉間線注射的批准將使我們能夠釋放肌肉運動障礙的機會。我們已經完成了針對頸肌張力障礙的第 3 期計劃和針對上肢痙攣的第 2 期計劃。這兩個項目的臨床數據都證明了 DaxibotulinumtoxinA 的注射效果和長達 24 週的中位持續時間。在 FDA 批准我們在眉間線的長效神經調節劑後不久，我們將準備好為頸肌張力障礙提交補充 BLA。

As a reminder, cervical dystonia would be our entry point into the over $900 million U.S. muscle movement disorder category that is expected to grow to $1.4 billion in the U.S. by 2026.

提醒一下，頸肌張力障礙將成為我們進入價值超過 9 億美元的美國肌肉運動障礙類別的切入點，預計到 2026 年美國將增長到 14 億美元。

In summary, we feel very good about the growth of our base business, our expanding RHA Collection and our pipeline in aesthetics and therapeutics, pending approval of DaxibotulinumtoxinA for Injection for glabellar lines.

總之，我們對我們的基礎業務的增長、我們不斷擴大的 RHA 系列以及我們在美學和治療方面的管道感到非常滿意，等待批准用於眉間線注射的 DaxibotulinumtoxinA。

With that, I'll turn the call over to Dustin, who will cover our performance in the second quarter. Dustin?

有了這個，我會把電話轉給達斯汀，他將在第二季度報導我們的表現。達斯汀？

Thank you, Mark. We're very proud and have delivered our best quarter of RHA sales in Q2 totaling $25.5 million, a 50% increase year-over-year. This brings our first half 2022 RHA sales, $46.3 million and cumulative sales since launch over $130 million. These are solid results, independent of neuromodulator telling us that RHA the product that stands on its own.

謝謝你，馬克。我們非常自豪，並在第二季度實現了 RHA 銷售額最好的一個季度，總計 2550 萬美元，同比增長 50%。這為我們帶來了 2022 年上半年 RHA 銷售額，4630 萬美元，自推出以來的累計銷售額超過 1.3 億美元。這些都是可靠的結果，獨立於神經調節劑告訴我們 RHA 是獨立存在的產品。

During the second quarter, we saw healthy demand and productivity across our accounts. Awareness and adoption continue to be driven by our targeted sales and marketing initiatives, world-class training and education programs and most importantly, high injector and consumer satisfaction. At the quarter end, we have over 4,000 accounts across our portfolio representing a strong base of practice partners all anticipating a PDUFA date of September 8th for DaxibotulinumtoxinA for Injection.

在第二季度，我們的客戶看到了健康的需求和生產力。我們有針對性的銷售和營銷計劃、世界一流的培訓和教育計劃，最重要的是，高噴油器和消費者滿意度繼續推動意識和採用。在本季度末，我們在我們的投資組合中擁有超過 4,000 個賬戶，代表了強大的實踐合作夥伴基礎，他們都預計 PDUFA 日期為 9 月 8 日，用於注射用 DaxibotulinumtoxinA。

We are also excited to continue to bring new innovation to market with the launch of our RHA Redensity. Redensity was approved by the FDA to a partner Teoxane SA and is the first and only FDA-approved dermal filler for both superficial dermal and dermal injection of perioral rhytids or lip line. It has the most stretch compared to RHA 2, RHA 3 and RHA 4 and a shallow of injection depth, allowing it to adapt to the highly dynamic moving areas of the lip. With Redensity, injectors can softer or fine tune the appearance of lip line, a challenging area to treat prior to the introduction of Redensity. And like the rest of the RHA Collection, the product is designed to closely resemble the natural HA found in the skin, results look natural and can last through 12 months.

隨著 RHA Redensity 的推出，我們也很高興能夠繼續將新的創新推向市場。 Redensity 獲得了 FDA 的合作夥伴 Teoxane SA 的批准，是第一個也是唯一一個獲得 FDA 批准的皮膚填充劑，用於表面皮膚和口周皺紋或唇線的真皮注射。與 RHA 2、RHA 3 和 RHA 4 相比，它具有最大的伸展性，並且注射深度較淺，使其能夠適應唇部的高動態移動區域。使用 Redensity，注射器可以軟化或微調唇線的外觀，這是在引入 Redensity 之前需要處理的具有挑戰性的區域。與 RHA 系列的其他產品一樣，該產品的設計與皮膚中的天然 HA 非常相似，效果看起來很自然，可以持續 12 個月。

Presenting now in the market, we have 4 dynamic formulations of fillers offer a wide range of injection depths across the continuum of consumer needs. RHA Redensity for fine tuning lips, RHA 2 for softening facial lines, RHA 3 for refined smoothing of wrinkles and folds, and RHA 4 for natural volume for severe folds, deeper deficits. In fact, we are the only company to have introduced 4 fillers to market within 2 years.

現在在市場上展示，我們有 4 種動態填充劑配方，可根據消費者需求的連續性提供廣泛的注射深度。 RHA Redensity 用於微調雙唇，RHA 2 用於柔化面部線條，RHA 3 用於精細撫平皺紋和褶皺，RHA 4 用於自然豐盈，用於嚴重褶皺和更深的缺陷。事實上，我們是唯一一家在 2 年內向市場推出 4 種填料的公司。

Consistent with the launch of RHA 2, RHA 3 and RHA 4, we complete the preview, our early training and education program with practice partners and we're very encouraged by the positive feedback we've received. Injectors said Redensity is different than anything they have had on their shelves. It's easy to inject and its ability to correct very fine lines around the mouth, fills the wait in existing products. They believe the product is essential and excited to have Redensity complement filler line. Consumer feedback has also been very positive and love the smooth and natural look with Redensity.

隨著 RHA 2、RHA 3 和 RHA 4 的推出，我們與實踐合作夥伴一起完成了預覽、早期培訓和教育計劃，我們對收到的積極反饋感到非常鼓舞。注射器說，再密度與他們貨架上的任何東西都不同。它易於注射，並且能夠糾正嘴巴周圍的細紋，填補了現有產品的等待期。他們相信該產品是必不可少的，並且很高興擁有 Redensity 補充填充線。消費者的反饋也非常積極，他們喜歡 Redensity 的流暢自然外觀。

RHA Redensity is also currently being evaluated in a clinical trial by our partner Teoxane SA for the correction of infraorbital hollows or tear troughs. This is another delicate area of the face and is challenging to treat and we're excited about the prospects of a potential label expansion of RHA Redensity.

我們的合作夥伴 Teoxane SA 目前也在一項臨床試驗中對 RHA Redensity 進行評估，以矯正眶下空洞或淚溝。這是面部的另一個敏感區域，治療起來具有挑戰性，我們對 RHA Redensity 潛在標籤擴展的前景感到興奮。

Turning to OPUL. We continue to make progress in driving adoption and building membership capabilities during the second quarter. Gross processing volume or GPV for Q2 was $166 million, up 23.2% year-over-year. On a trailing 12-month basis, GPV totaled over $600 million at the end of Q2. As a reminder, we believe GPV is an important indicator of our future revenue potential in the U.S. aesthetics payment processing market and opportunity to exceed $0.5 billion per year.

轉向歐普。我們在第二季度繼續在推動採用和建立會員能力方面取得進展。第二季度的總處理量或 GPV 為 1.66 億美元，同比增長 23.2%。在過去 12 個月的基礎上，截至第二季度末，GPV 總計超過 6 億美元。提醒一下，我們認為 GPV 是我們未來在美國美容支付處理市場的收入潛力和每年超過 5 億美元的機會的重要指標。

We will continue to focus on new features and account growth for OPUL, it not only deepens our relationships with our practice partners, but also unlock additional revenue potential for Revance.

我們將繼續關注 OPUL 的新功能和客戶增長，這不僅加深了我們與實踐合作夥伴的關係，還為 Revance 釋放了額外的收入潛力。

In summary, we feel really good about how our aesthetics portfolio is poised for additional growth. Particularly with the addition of DaxibotulinumtoxinA for Injection in glabellar line if approved. Our attention is focused on our September 8th PDUFA date. We are very much looking forward to introducing a differentiated performance profile of our next generation neuromodulator to the U.S. aesthetic market. Consistent with our approach to the launch of the RHA Collection, the commercial launch of DaxibotulinumtoxinA for Injection will be preceded by our preview program with lead practice partners.

總而言之，我們對我們的美學產品組合如何準備好實現額外增長感到非常滿意。如果獲得批准，尤其是在眉間線中添加註射用 DaxibotulinumtoxinA。我們的注意力集中在 9 月 8 日的 PDUFA 日期。我們非常期待將我們的下一代神經調節劑的差異化性能配置文件引入美國美容市場。與我們推出 RHA 系列的方法一致，在商業推出注射用 DaxibotulinumtoxinA 之前，我們將與主要實踐合作夥伴進行預覽計劃。

Finally, recently participated in the 2022 TOXINS International Conference, we presented data on DaxibotulinumtoxinA for Injection that includes new data demonstrating the unique properties of our novel excipient peptide. Our poster showcase how the -- positively charged excipient peptide combined directly to the core neurotoxin and can enhance the binding of the neurotoxin to [cell]. The new data underscore DaxibotulinumtoxinA for Injection, innovative formulation and our commitment to the advancement of research of neurotoxin in both aesthetics and therapeutic indications.

最後，在最近參加的 2022 TOXINS 國際會議上，我們展示了注射用 DaxibotulinumtoxinA 的數據，其中包括展示我們新型賦形劑肽的獨特性質的新數據。我們的海報展示了帶正電荷的賦形劑肽如何直接與核心神經毒素結合，並可以增強神經毒素與 [細胞] 的結合。新數據強調了注射用大西肉毒桿菌毒素A、創新配方以及我們對推進神經毒素在美學和治療適應症研究方面的承諾。

With that, I will turn the call over to Toby to cover our second quarter financials.

有了這個，我將把電話轉給托比來報導我們第二季度的財務狀況。

Thank you, Dustin. Total revenue for the second quarter of 2022 increased 51% from the same period in 2021 to $28.4 million, primarily driven by increased sales of the RHA Collection. Revenue for the second quarter included $25.5 million of product revenue, $1.7 million of collaboration revenue and $1.2 million of service revenue.

謝謝你，達斯汀。 2022 年第二季度的總收入較 2021 年同期增長 51% 至 2840 萬美元，主要受 RHA Collection 銷售額增長的推動。第二季度的收入包括 2550 萬美元的產品收入、170 萬美元的協作收入和 120 萬美元的服務收入。

Turning to operating expenses. We continue to execute on our corporate priority of disciplined cash, capital allocation in addition to our ongoing cash preservation measures. GAAP operating expenses for the second quarter were $86.2 million compared to $89.1 million for the same period last year. Excluding depreciation, amortization and stock-based compensation, our non-GAAP operating expenses were $62.0 million, an 8% decline over the same period last year due to lower SG&A expenses and lower R&D costs related to clinical trial and regulatory activities. For the 6 months ended June 30, 2022, non-GAAP operating expenses were down 7% compared to the same period last year.

轉向運營費用。除了我們正在進行的現金保全措施外，我們將繼續執行我們的公司優先事項，即有紀律的現金、資本分配。第二季度的 GAAP 運營費用為 8620 萬美元，而去年同期為 8910 萬美元。不計折舊、攤銷和股票補償，我們的非公認會計原則運營費用為 6200 萬美元，比去年同期下降 8%，原因是與臨床試驗和監管活動相關的 SG&A 費用和研發成本降低。截至 2022 年 6 月 30 日的 6 個月，非美國通用會計準則運營費用與去年同期相比下降了 7%。

As a reminder, we project R&D expense in 2022 to be primarily driven by manufacturing costs for DaxibotulinumtoxinA for Injection which according to GAAP accounting standards, our expense to the period costs until the drug product is approved. As for our operating expense outlook, we maintain our previously announced GAAP and non-GAAP expense guidance for 2022.

提醒一下，我們預計 2022 年的研發費用將主要由注射用大西肉毒桿菌毒素 A 的製造成本驅動，根據 GAAP 會計準則，我們在藥品獲得批准之前的期間費用。至於我們的運營費用前景，我們維持之前公佈的 2022 年 GAAP 和非 GAAP 費用指引。

Turning to our balance sheet. Our total cash, cash equivalents and short-term investments as of June 30, 2022 were $233.8 million. Recall that we enhance our financial flexibility earlier this year with the closing of a $300 million note purchase agreement with Athyrium Capital. We issued the first $100 million note payable on the closing of the agreement in March 2022. Pending the approval of DaxibotulinumtoxinA for Injection, we will have the option to initiate issue another $100 million note until September 2023. An additional option of uncommitted borrowings of up to $100 million is available on commercial revenue target achievement.

轉向我們的資產負債表。截至 2022 年 6 月 30 日，我們的現金、現金等價物和短期投資總額為 2.338 億美元。回想一下，我們在今年早些時候與 Athyrium Capital 達成了 3 億美元的票據購買協議，從而提高了我們的財務靈活性。我們在 2022 年 3 月協議結束時發行了第一張 1 億美元的票據。在註射用大西肉毒桿菌毒素 A 獲得批准之前，我們可以選擇在 2023 年 9 月之前再開始發行 1 億美元的票據。未承諾借款的額外選擇權達到 1 億美元可用於實現商業收入目標。

We believe, we have the cash runway into 2024 with the additional $100 million in committed notes available subject to the FDA approval of our neuromodulator.

我們相信，我們擁有到 2024 年的現金跑道，另外還有 1 億美元的承諾票據可用，但須經 FDA 批准我們的神經調節劑。

Finally, Revance's shares of common stock outstanding as of July 29, 2022, were approximately 73.1 million with 80.7 million fully diluted shares, excluding the impact of convertible debt.

最後，截至 2022 年 7 月 29 日，Revance 的已發行普通股約為 7310 萬股，其中不包括可轉換債務的影響，其中 8070 萬股完全攤薄。

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

有了這個，我會把電話轉回給馬克。

Thank you, Toby. Our commercial track record since launching 2 years ago continues to give me confidence in our people, strategy and our innovative portfolio of products and services. Importantly, it also gives me confidence in our ability to successfully launch DaxibotulinumtoxinA for Injection get approved and to begin realizing our therapeutic potential post-approval.

謝謝你，托比。自 2 年前推出以來，我們的商業記錄繼續讓我對我們的人員、戰略以及我們創新的產品和服務組合充滿信心。重要的是，這也讓我對我們成功推出注射用大西肉毒桿菌毒素 A 獲得批准並開始實現我們批准後的治療潛力的能力充滿信心。

I'd like to thank the clinical, manufacturing, operations, and regulatory team for the successful resubmission of our BLA and for their hard work in preparing for the recent re-inspection of our manufacturing facility.

我要感謝臨床、製造、運營和監管團隊成功重新提交了我們的 BLA，並感謝他們為最近重新檢查我們的製造設施所做的辛勤工作。

I'd also like to thank the commercial team for their excellent performance in the first half of the year. We look forward to the tremendous opportunities ahead and to updating you on our progress along the way.

我還要感謝商業團隊上半年的出色表現。我們期待著未來的巨大機遇，並在此過程中向您通報我們的進展。

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) And our first question comes from the line of Seamus Fernandez with Guggenheim Partners.

（操作員說明）我們的第一個問題來自古根海姆合作夥伴 Seamus Fernandez 的台詞。

Thanks for all the detail on the manufacturing and FDA updates, guys. So just a couple of quick questions there. As you review the additional observations and first off, congrats on closing the 5 observations. I'm sure that was challenging and a great relief to see that closed out. But on the 3 additional observations, they strike us as minor as we kind of read those observations. But what does your consultants kind of say about those observations and can you just give us any color on your thoughts? It obviously seems like you feel quite good heading into the PDUFA date on September 8.

感謝您提供有關製造和 FDA 更新的所有詳細信息，伙計們。所以這裡只是幾個簡單的問題。當您查看其他觀察結果時，首先，恭喜您關閉了 5 個觀察結果。我敢肯定，看到它結束，這是一個挑戰，也是一種極大的解脫。但是在另外 3 個觀察結果中，它們對我們的影響很小，就像我們閱讀這些觀察結果一樣。但是你的顧問對這些觀察有什麼看法？你能告訴我們你的想法嗎？顯然，您在 9 月 8 日進入 PDUFA 日期時感覺很好。

And the second question, just wanted to get a little bit of the color as we speak with physicians, some experts basically talk about their experience in clinical trials with DAXI seeing a little bit of a different sort of spreading dynamic versus what one might experience with BOTOX. How are you guys, how do you think about that? Is that sort of a clinical advantage from your perspective or is it something that will become a clinical advantage once the physicians are actually experienced with the product?

第二個問題，只是想在我們與醫生交談時獲得一點色彩，一些專家基本上談論他們在 DAXI 的臨床試驗中的經驗，看到一點不同的傳播動態與人們可能經歷的不同肉毒桿菌。你們好嗎，你們怎麼看？從您的角度來看，這是一種臨床優勢，還是一旦醫生對產品有實際經驗，它就會成為臨床優勢？

Thanks, Seamus. So first off, you mentioned we're very pleased with our ability to retire the 5 observations from the original Form 483 observations. And to your point, it was great work by the team to quit the resubmission package together to address sort of the outstanding items that were agreed upon with the agency where we needed to re-qualify that cell banks. So again, it's certainly heartening to us and the team to close out those 5 observations.

謝謝，西莫。所以首先，你提到我們很高興我們能夠從最初的 483 表中刪除 5 個觀察結果。就您的觀點而言，團隊一起退出重新提交包以解決與機構商定的未完成項目，我們需要重新認證細胞庫，這是一項了不起的工作。再說一次，結束這 5 個觀察結果對我們和團隊來說無疑是令人振奮的。

It's probably not appropriate for us to comment on kind of on the 3 observations that we got this latest go around just because of where we are with the agency that we said normally we wouldn't be commenting on these things. But given the news that we received this morning that a redacted version of our Form 483 may become public prior to our PDUFA date, we thought was important that all shareholders have the same information. But we feel very good about the responses that we pulled together. They were complete, they were comprehensive. There is nothing else in outstanding related to the responses to those 3 observations and we continue to feel very good that we'll get a response from the agency on our application by the PDUFA date of September 8.

我們可能不適合對我們最近得到的 3 個觀察結果發表評論，因為我們在該機構工作，我們通常說我們不會對這些事情發表評論。但鑑於我們今天早上收到的消息，即我們的 483 表格的編輯版本可能會在我們的 PDUFA 日期之前公開，我們認為所有股東都擁有相同的信息很重要。但我們對我們匯總的響應感覺非常好。它們是完整的，它們是全面的。對這 3 項意見的答复沒有其他未解決的問題，我們仍然感到非常高興，我們將在 9 月 8 日的 PDUFA 日期之前收到該機構對我們申請的答复。

In terms of your second question regarding color on DAXI and does it spread differently or anything like that. We long talked about sort of a staged rollout that we're going to go through, but I'd like to hand it over to Dustin, so he can provide a little bit more commentary on that.

關於你關於 DAXI 顏色的第二個問題，它的傳播方式是否不同或類似。我們一直在談論我們將要進行的分階段推出，但我想把它交給達斯汀，這樣他就可以提供更多的評論。

Yes. Thanks, Seamus for your question. I think if we look at the majority of the study work that was done with DAXI within glabellar line and it was very, very well received by those injector sites. We've got to remind the DAXI is the first and ever unique formulation that is stabilized with our proprietary peptide. So it will act a bit differently with other products.

是的。謝謝，Seamus 的問題。我認為，如果我們看看在眉間線內使用 DAXI 完成的大部分研究工作，這些注射部位都非常非常好地接受了它。我們必須提醒一下，DAXI 是第一個使用我們專有的肽進行穩定的獨特配方。因此，它與其他產品的作用會有所不同。

As it relates to specific spreading or different characteristics relative to that, I'm not aware of any data that is able to compare with that. It's actually some of the data that we actually just released at Toxins Talks about the positive charge the finding and anchoring of how that peptide stays attached to the DaxibotulinumtoxinA molecule, once it's been reconstituted. So you ultimately would think that there is actually a different effect and that you would have more of an anchoring effect around those areas.

由於它與特定的傳播或與之相關的不同特徵有關，我不知道有任何數據可以與之進行比較。這實際上是我們剛剛在 Toxins Talks 上發布的一些數據，這些數據是關於正電荷的發現和錨定，一旦它被重組，該肽如何保持附著在 DaxibotulinumtoxinA 分子上。因此，您最終會認為實際上存在不同的效果，並且您會在這些區域周圍產生更多的錨定效果。

Obviously, as Mark mentioned, this is a different product and it will take a little bit of time for the practices to find their specific recipe. We're really happy with the results that they have in clinical trials. Once they go into real world setting, they would like to tweak things based off of look that they have. And so, we look forward to providing them the opportunity with our preview program. But all in all, we've been very pleased with both the efficacy, duration profile, and the safety profile DAXI across both glabellar line and then with our upper facial lines, lateral canthal lines, and ultimately forehead lines Phase 2 data.

顯然，正如馬克所提到的，這是一種不同的產品，實踐需要一點時間才能找到它們的具體配方。我們對他們在臨床試驗中的結果感到非常滿意。一旦他們進入現實世界的設置，他們會想根據他們所擁有的外觀來調整事物。因此，我們期待通過我們的預覽計劃為他們提供機會。但總而言之，我們對 DAXI 跨越眉間線、上面部線、外眥線以及最終的前額線第 2 階段數據的療效、持續時間和安全性都非常滿意。

And your next question comes from the line of Ken Cacciatore with Cowen.

您的下一個問題來自 Ken Cacciatore 和 Cowen 的台詞。

Maybe I'll just try to follow-up and see if I can get a bit of a different answer. Is there any sense as you look at these observations, whether there would be a need to actually on-site, inspect? And then maybe part of that, can you talk about whether we're engaged in label discussions? Just wondering if you can give any more detail. And then in terms of the rollout, I know previously we talked about wanting to be a bit selective as we rolled out DAXI with the hopeful approval. Mark, if you can give us a little bit of sense, is it going to be necessary for you to actually train a clinician? Do they have to kind of get through a bit of a process? Can you just talk about how you're going to come to roll this out in the 4,000 accounts that you currently have? Can you give us any sense about the volume that they do, this is a situation where these accounts are 50% of the botulinum toxin volume or I'm throwing out a random number to see if you'll contextualize for us kind of the initial account basin and what their current volume is in terms of botulinum toxin?

也許我會嘗試跟進，看看我是否能得到一些不同的答案。當您查看這些觀察結果時，是否有任何意義，是否需要實際現場檢查？然後也許是其中的一部分，你能談談我們是否參與了標籤討論嗎？只是想知道您是否可以提供更多詳細信息。然後在推出方面，我知道之前我們談到希望在推出 DAXI 時有所選擇，並獲得了有希望的批准。馬克，如果你能給我們一點感覺，你是否有必要實際培訓臨床醫生？他們是否必須經歷一些過程？您能否談談您將如何在您目前擁有的 4,000 個帳戶中推出此功能？你能告訴我們他們所做的數量嗎？在這種情況下，這些賬戶佔肉毒桿菌毒素數量的 50%，或者我拋出一個隨機數，看看你是否會為我們提供最初帳戶盆地及其當前的肉毒桿菌毒素量是多少？

Thanks, Ken. So in regards to your first question, do we expect with the 3 observations that we summarized in the recent Form 483 to expect reinspection? We provided comprehensive responses to the observations. There is no additional data that we're waiting on. I mean not appropriate for us to comment exactly on how the FDA will receive the responses. But we feel very good in terms of what we were able to put in the responses and felt that we were able to provide a comprehensive response to the -- for identifying. And so we continue to believe that this September 8, PDUFA date is a good day, and again, going back to kind of the comment earlier, we feel really good that we were able to close out the 5 observations from the original Form 483.

謝謝，肯。因此，關於您的第一個問題，我們是否期望我們在最近的 483 表中總結的 3 個觀察結果期待重新檢查？我們對觀察結果提供了全面的回應。沒有我們正在等待的其他數據。我的意思是，我們不適合就 FDA 將如何收到回复做出確切評論。但就我們能夠在回復中提供的內容而言，我們感覺非常好，並且認為我們能夠對 - 進行識別提供全面的回复。因此，我們繼續相信今年 9 月 8 日 PDUFA 日期是個好日子，再次回到之前的評論，我們能夠結束原始 483 表中的 5 個觀察結果，我們感到非常高興。

On the label itself, again when we received sort of the CRL last time, we communicated at that point in time that we -- everything else had already been wrapped up at that point. The only thing was outstanding with the inspection of our facility and so there is no new updates there. We believe that the FDA label negotiations were already included. And so there is no update to that.

在標籤本身上，當我們上次收到某種 CRL 時，我們在那個時間點傳達了我們 - 那時其他所有東西都已經包裝好了。唯一值得一提的是我們的設施檢查，所以那裡沒有新的更新。我們認為 FDA 的標籤談判已經包括在內。所以沒有更新。

So the last one in regards to sort of the rollout of DAXI, I'll hand this over to Dustin in a second, but we often sort of characterize the market is roughly 40,000 accounts of which you know we're targeting the top third as part of our prestige strategy. So this call 13,000 to 15,000 accounts really in 4,000 of those. They were still in a subset of those accounts. And so we still have ways to go. I don't know that we're in a position to be able to comment in terms of the percent of the toxin market that those 4,000 accounts occupy. But I'll let him speak to sort of the rollout on strategy in greater detail.

所以最後一個關於 DAXI 的推出，我會在一秒鐘內把它交給達斯汀，但我們通常將市場定性為大約 40,000 個賬戶，你知道我們的目標是前三分之一我們聲望戰略的一部分。所以這調用了 13,000 到 15,000 個帳戶，其中有 4,000 個。他們仍然在這些賬戶的一個子集中。所以我們還有很長的路要走。我不知道我們是否能夠就這 4,000 個帳戶所佔據的毒素市場百分比發表評論。但我會讓他更詳細地談談戰略的推出。

Yes. And thank you, Mark. So as it relates to DAXI, we're going to follow the proven track record we've had for rolling out products with our preview program. Although this will bring some of our providers to our Nashville headquarters. We were able to rollout a significant training program focused really on 3 areas.

是的。謝謝你，馬克。因此，由於它與 DAXI 相關，我們將遵循我們通過預覽計劃推出產品的可靠記錄。儘管這會將我們的一些供應商帶到我們的納什維爾總部。我們能夠推出一個真正專注於 3 個領域的重要培訓計劃。

First, clinical. As you know we need to go through the clinical duration profile of DAXI from an efficacy perspective and safety perspective, both across all of our clinical trial Phase 3 and Phase 2. We will also talk about our formulation. Mentioned earlier, this is the first and ever formulated product with the peptide that delivers efficacy in duration with similar amount of API and other products in the markets. We'll go through that.

一是臨床。如您所知，我們需要從療效和安全性的角度了解 DAXI 的臨床持續時間概況，包括我們所有的臨床試驗 3 期和 2 期。我們還將討論我們的配方。前面提到過，這是第一個也是有史以來第一個含有肽的產品，可以在持續時間內提供與市場上類似數量的 API 和其他產品的功效。我們會經歷那個。

And then lastly practice integration. We see often it's important for practices to understand, not only the profile, how to inject the product, but how to actually integrate into practice, how to charge and how to convince consumers it's the right product for them. So focus on all of that will also get those key learnings through that period of time around the minor fleets that injectors will make around kind of the recipe for exactly how they like to utilize DAXI in a real world setting. And then we'll go broader into our practice partners. The RHA, folks that have leaned in without RHA, as well as with OPUL.

然後最後練習整合。我們經常看到，實踐很重要，不僅要了解概況、如何注入產品，還要了解如何實際融入實踐、如何收費以及如何說服消費者這是適合他們的產品。因此，專注於所有這些也將在一段時間內圍繞小型車隊獲得那些關鍵的學習，這些小型車隊將圍繞他們喜歡如何在現實世界環境中使用 DAXI 的配方。然後我們將更廣泛地涉及我們的實踐合作夥伴。 RHA，那些在沒有 RHA 和 OPUL 的情況下靠攏的人。

And then, just a comment on your final question. We felt like the prestige category represents roughly 50% of the aesthetic marketplace. And so we feel very good that the foundation for the accounts that we're in will be a great foundation to start for DaxibotulinumtoxinA for Injection.

然後，只是對您的最後一個問題發表評論。我們覺得聲望類別代表了大約 50% 的審美市場。因此，我們感到非常高興，我們所擁有的賬戶的基礎將成為開始注射用 DaxibotulinumtoxinA 的良好基礎。

And your next question comes from the line of Annabel Samimy with Stifel.

你的下一個問題來自 Annabel Samimy 和 Stifel 的台詞。

Just a follow-up on the rollout. Can you just confirm that the rollout that you plan, is it already full overlap with those accounts that are using RHA filler or are you reaching out to different accounts who may have not adopted RHA filler but were very, very close, like KOLs or clinical trialers who had already used DAXI. So I'm just curious about that.

只是對推出的後續行動。您能否確認您計劃的推出，是否已經與使用 RHA 填充物的那些帳戶完全重疊，或者您是否正在聯繫可能沒有採用 RHA 填充物但非常非常接近的不同帳戶，例如 KOL 或臨床已經使用過DAXI的試用者。所以我只是對此感到好奇。

And the second question I have is, you know, we've all done surveys regarding the reception to long-acting products and clearly they are viewed as very differentiated and they would have strong reception, strong penetration. But there are some view still in the market that this would still be niche, because if you drill down a little further, they may not use it as broadly -- in the broad population as typical. So what are you finding when you drill down with your -- in your market research today? Do they receive and expect penetration of broadly is what we're receiving in our surveys that we do probably unless detailed forecasting you do? Thanks.

我的第二個問題是，你知道，我們都做過關於長效產品接受度的調查，很明顯它們被認為是非常差異化的，它們會有很強的接受度和滲透力。但是市場上仍有一些觀點認為這仍然是利基市場，因為如果你再深入一點，他們可能不會像典型的那樣廣泛使用它——在廣泛的人群中。那麼，當您在今天的市場研究中深入研究時，您會發現什麼？他們是否接受並期望廣泛的滲透是我們在調查中收到的，除非您進行詳細的預測，否則我們可能會這樣做？謝謝。

I'll take first those, then Mark can add on if he feels appropriate. So on the rollout, no, I'm not in a position to go specific physician-by-physician, injector-by-injector. But our first and primary focus is on outcomes. Who are going to be those that are going to help us through this process and focus on getting great outcomes and also those that have leaned in with us will be a combination of those groups.

我會先拿那些，然後如果馬克覺得合適，他可以補充。因此，在推出時，不，我無法逐個醫生，逐個注射器進行特定的醫生。但我們的首要重點是結果。誰將成為那些將幫助我們完成這個過程並專注於獲得偉大成果的人，而那些與我們合作的人將是這些群體的組合。

It's important to look at how providers learn from each other in today's environment, both from a podium perspective, but also from a hands-on perspective and also those that are willing to work with us on this journey of how do we maximize that practice integration, learn from those launches that happened previously. So it'll be a combination of those groups.

重要的是要看看提供者在當今環境中如何相互學習，無論是從講台的角度，還是從實踐的角度，以及那些願意與我們合作，我們如何最大限度地實現實踐整合的人，從以前發生的那些發射中學習。所以它將是這些組的組合。

As it relates to kind of our market research, we feel very good that the consumer uptake and the practice uptake of this product will be well received. It's got a unique value proposition that it is the first product. It offers something different to botulinum toxin patients both from an efficacy perspective and a duration perspective. All others are formally more similar to the same. With this peptide and our clinical profile, we believe that whether they're getting toxin 4 times a year or more likely, most of them getting toxin 1.8 times a year. This is going to have a value if they get injected with DaxibotulinumtoxinA for Injection twice a year, that aesthetic looked at they will receive with DAXI, will be different than anything that they have had with other toxins. And so we feel really good that it can add value across a variety of segments.

由於它與我們的市場研究有關，我們感到非常高興的是，該產品的消費者接受度和實踐接受度將受到好評。它有一個獨特的價值主張，它是第一個產品。從療效的角度和持續時間的角度來看，它都為肉毒桿菌毒素患者提供了一些不同的東西。所有其他的在形式上都更相似。憑藉這種肽和我們的臨床概況，我們相信無論他們每年獲得 4 次或更可能的毒素，他們中的大多數人每年獲得 1.8 次毒素。如果他們每年兩次注射 DaxibotulinumtoxinA 進行注射，這將是有價值的，他們將收到 DAXI 的審美，將不同於他們使用其他毒素的任何東西。因此，我們對它可以為各個細分市場增加價值感到非常高興。

Yes. And I'll just still add to that, Annabel. So we certainly don't see this as a niche market. Certainly, it will have its place and we long talked about the nice thing about having a long-acting alternative is it gives practices and consumers a choice. And so it doesn't need to be a one size fits all, but we'll provide, we believe the valuable alternative for both patients and practice. Our market research suggests that both consumers and injectors identifying the lack of duration is being the number one unmet need and that's reported out at over 80% in both of those categories, which toxins is kind of amazing that you've got these procedures that are being done millions of times a year. And despite that, they continue to express disappointment with the duration of the existing products. And so, we believe that this will be a really nice add to the armamentarium of the practices and the providers and an alternative for consumers and we don't expect it to be everything to everybody, but we do expect it's going to resonate and that will be a large portion of patients and injectors that look to this is an alternative.

是的。我還要補充一點，安娜貝爾。所以我們當然不認為這是一個利基市場。當然，它會佔有一席之地，我們長期以來一直在談論擁有長效替代品的好處是它為實踐和消費者提供了選擇。因此，它不需要千篇一律，但我們會提供，我們相信對患者和實踐都有價值的替代方案。我們的市場研究表明，消費者和注射者都發現缺乏持續時間是第一個未滿足的需求，據報導，這兩個類別中的比例都超過了 80%，哪些毒素有點令人驚訝，因為你有這些程序是每年完成數百萬次。儘管如此，他們仍然對現有產品的持續時間表示失望。因此，我們相信這將是對實踐和提供者的軍備庫的一個非常好的補充，也是消費者的替代品，我們不希望它對每個人都適用，但我們確實希望它會引起共鳴，並且將有很大一部分患者和注射器認為這是一種替代方案。

And your next question comes from the line of David Amsellem from Piper Sandler.

您的下一個問題來自 Piper Sandler 的 David Amsellem。

So just couple of questions. Just going back to the Form 483, I guess maybe I'll sort of take a different angle and ask you, Mark, if you were surprised at getting additional observation. Is this something where you were caught flat-footed or there is something that you had an inkling might happen. Just wanted to see if we can gain any insights there?

所以只是幾個問題。回到 483 表，我想也許我會換個角度問你，馬克，你是否對得到額外的觀察感到驚訝。這是您措手不及的事情，還是您有預感的事情可能會發生。只是想看看我們是否可以在那裡獲得任何見解？

And then secondly, on RHA. You talked about consumer behavior and you're not seeing anything beyond seasonality. I mean, I guess the question is going forward as the footprint of the product grows to the extent there is still, these macroeconomic pressures. Do you look at 4Q, which is the strongest season in this phase as potentially a trouble spot, if you will? I -- to get your thoughts on how you think that part of the year might play out, given the backdrop that we've been talking about.

其次，在 RHA 上。你談到了消費者行為，除了季節性之外，你沒有看到任何東西。我的意思是，我想隨著產品的足跡增長到仍然存在這些宏觀經濟壓力的程度，這個問題正在向前發展。如果您願意的話，您是否將 4Q 這個階段中最強的季節視為潛在的麻煩點？鑑於我們一直在談論的背景，我 - 想知道你認為今年那部分時間可能會如何發展。

Yes, thanks, David. So first question, were we surprised or disappointed? I mean clearly, when you prepare for an inspection, you're hoping that you all can have any observations, right. So but I'll say, but the team did an amazing job and they're going to come back to the fact that we closed out the 5 observations from the first Form 483. So I think the team did a great job there.

是的，謝謝，大衛。所以第一個問題，我們是驚訝還是失望？我的意思很清楚，當你準備檢查時，你希望大家能有任何觀察，對吧。所以，但我會說，但團隊做得很棒，他們將回到我們關閉第一個表格 483 中的 5 個觀察的事實。所以我認為團隊在那裡做得很好。

As you'll see from the summary that we provided Items 1 and 2 related to single development batches, where we get a follow kind of a procedure or in SOP, hence you're talking about a single batch where that was the case. We provided very comprehensive responses, there is nothing else that's outstanding. And so certainly everybody would love not to had any observations, but we liking it sometimes to home inspection. You kind of get prepared and you're ready and the findings. But again, I think our team did a great job. And again, I'll come back to very proud and pleased with sort of the timeliness and the comprehensiveness of the response that was put forward.

正如您從總結中看到的那樣，我們提供了與單個開發批次相關的第 1 項和第 2 項，我們在其中獲得了一種遵循程序或在 SOP 中，因此您在談論的是單個批次。我們提供了非常全面的回應，沒有什麼特別突出的。所以當然每個人都希望不要有任何觀察，但我們有時喜歡家庭檢查。你有點準備好了，你已經準備好和調查結果了。但同樣，我認為我們的團隊做得很好。再說一次，我會再次對所提出的響應的及時性和全面性感到非常自豪和滿意。

In terms of consumer behavior, I think there's a few things that are worth noting. First off going into Q4, we'll have to wait until we are closer to that to make any commentary on the Q4 side of things, but you know, as you're aware, this is a market segment that has proven to be fairly resilient through other economic downturns 2008-2009 coming out of the pandemic these are procedures, certainly, the facial injectables that start to become a little bit more integrated into lifestyle and so they're less sort of discretionary and more conventional for these patients. And so, maybe it's that we're calling on a smaller subset of practices that we are kind of lumping into this prestige category.

在消費者行為方面，我認為有幾點值得注意。首先進入第四季度，我們將不得不等到我們更接近第四季度才能對第四季度的事情發表任何評論，但你知道，正如你所知，這是一個已被證明是公平的細分市場在 2008-2009 年因大流行而出現的其他經濟衰退中具有彈性，這些程序當然是面部注射劑，它們開始更加融入生活方式，因此對於這些患者來說，它們不那麼隨意，更傳統。因此，也許我們正在呼籲一小部分實踐，我們將其歸為這一聲望類別。

But thus far, or at least today, we're just not seen sort of a softening and even if you go back over time, and you look at periods of time where macroeconomic conditions did plan it did have an impact, but it was certainly more muted than other discretionary spending items. And as we pointed out before, we're also in kind of a launch base with re-density, having just launched on the RHA side, we're still early in 4,000 accounts and for our neuromodulator, if approved that's going to give us yet another new innovation to bring into the market. And so, we're going to have some things that counterbalance any macroeconomic conditions should they, and to be more pronounced in Q4 going forward.

但到目前為止，或者至少在今天，我們只是沒有看到某種軟化，即使你隨著時間的推移而回溯，你看看宏觀經濟狀況確實計劃它確實產生影響的時期，但它肯定是比其他可自由支配的支出項目更加低調。正如我們之前指出的那樣，我們也處於一種重新密度的發射基地，剛剛在 RHA 方面發射，我們仍處於早期的 4,000 個帳戶中，對於我們的神經調節器，如果獲得批准，這將給我們又一項新的創新將帶入市場。因此，我們將採取一些措施來抵消任何宏觀經濟狀況，並在未來的第四季度更加明顯。

And your next question comes from the line of Tim Lugo with William Blair.

您的下一個問題來自 Tim Lugo 和 William Blair。

I guess regarding the third observation mentioned in the press release about not adding redundant sites, the storage of the working cell bank, I think the last form for a degree mentioned the lack of having a working cell bank, can you just remind us what are the issues with having a working cell bank and how difficult is it to add this redundant sites and the fact that may be the working cell bank if it doesn't seem to be repeating again now that within this 3 new observation. Can you just kind of, I guess, when I'm talking through this and clarify as much as you can?

我想關於新聞稿中提到的關於不添加冗餘站點的第三個觀察，工作細胞庫的存儲，我認為學位的最後一種形式提到缺乏工作細胞庫，你能提醒我們什麼是擁有工作細胞庫的問題以及添加這些冗餘站點的難度以及如果在這 3 個新觀察中它似乎不再重複的話，它可能是工作細胞庫的事實。我想，當我談論這個並儘可能多地澄清時，你能不能有點？

Sure, Tim. So, we use sort of third-party redundant facilities to store and maintain some of our cell bank material for kind of more disaster purposes. This is a third-party signed that is already registered with us that we already used. And so, the issue for number 3 was that in our BLA filing, we had not updated that site to include the newly qualified working cell banks. So, we took care of that, we did in our filing address the addition of the new working cell bank to that third-party redundant storage facility, which is already under registration with us.

當然，蒂姆。因此，我們使用某種第三方冗餘設施來存儲和維護我們的一些細胞庫材料，以用於更多的災難目的。這是已在我們這裡註冊且我們已經使用的第三方簽名。因此，第 3 項的問題是，在我們的 BLA 文件中，我們沒有更新該站點以包含新合格的工作細胞庫。因此，我們處理了這一點，我們在提交地址中將新的工作單元庫添加到了已經在我們註冊的第三方冗餘存儲設施中。

Okay. That sounds easy enough. I guess from a 10,000-foot perspective, I know, none of this is easy when it comes to manufacturing, but the lack the kind of on validated working cell bank was raised again does that -- are we able to kind of jump ahead and think that was all of those issues have been mitigated from the last Form 483?

好的。這聽起來很容易。我想從 10,000 英尺的角度來看，我知道，在製造方面，這一切都不是一件容易的事，但是缺乏經過驗證的工作細胞庫再次被提出來做到這一點——我們能夠向前跳躍嗎？認為所有這些問題都已從上一份 483 表格中得到緩解？

Yes, that's what we tried to communicate in sort of our prepared remarks. So, the lack of a qualified cell bank at the time the FDA showed up the last time was part of one of the 5 observations and we indicated that after our Type A meeting, the FDA was clear in terms of what they needed to see from us in order for us to resubmit our BLA and provide them with the necessary information and ultimately what they wanted with the qualification of the new cell bank with 3 consecutive drug substance batches in one drug product app. So, we provided all that information in our resubmission and at the recent inspection of our facility, they indicated that we have successfully addressed the 5 observations in the original Form 483.

是的，這就是我們試圖通過準備好的評論來傳達的內容。因此，FDA 上次出現時缺乏合格的細胞庫是 5 項觀察之一的一部分，我們表示，在我們的 A 類會議之後，FDA 很清楚他們需要從哪些方面看到我們為了讓我們重新提交我們的 BLA 並向他們提供必要的信息，並最終提供他們想要的新細胞庫的資格，在一個藥品應用程序中具有 3 個連續的原料藥批次。因此，我們在重新提交時提供了所有這些信息，並且在最近對我們設施的檢查中，他們表示我們已經成功解決了原始表格 483 中的 5 個觀察結果。

So we feel very good and those have been closed after. There is nothing open right now as it relates to the cell bank or the qualification of the cell bank. The summary that we provided of the Form 483 is that we're recently provided are the only things that are outstanding. And again as I mentioned, we have provided all of the responses to those 3 questions with nothing that remains us any piece from our end.

所以我們感覺很好，之後那些已經關閉了。目前沒有任何開放的內容，因為它與細胞庫或細胞庫的資格有關。我們提供的 483 表格的摘要是，我們最近提供的是唯一未完成的事情。再次正如我提到的，我們已經提供了對這 3 個問題的所有答复，沒有任何東西可以從我們的最終結果中保留下來。

Your next question comes from the line of Douglas Tsao from H.C. Wainwright.

您的下一個問題來自 H.C. 的 Douglas Tsao。溫賴特。

Just going back to the 483, I just want to clarify this one point. So, it sounds like both these observations were related to a single lot but it sounds like this lot was boarded. So, with this lot -- this lot to clarify or confirm was not used to satisfy the requirements of the original Complete Response Letter?

回到483，我只想澄清這一點。所以，聽起來這兩個觀察結果都與一個批次有關，但聽起來這個批次被登機了。那麼，對於這批——這批澄清或確認不是用來滿足原始完整回复信的要求？

That's correct, Doug. So, these are 2 individual development lots. The one was awarded based on sort of the league that be summarized, there. The other one with a separate development block neither then used for any sort of clinical trials for sort of our validation process. These were independent development loss.

沒錯，道格。因此，這是 2 個單獨的開發批次。一個是根據那裡總結的聯賽類型授予的。另一個具有單獨的開發模塊，既不用於任何類型的臨床試驗，也用於我們的驗證過程。這些是獨立的發展損失。

Okay, great. And so they don't, just to confirm again they don't affect BLA in any way or sort of the meet of the BLA besides just addressing these process issues, which I know are important, but they don't have implicate -- broader implications for the FDA's evaluation of the BLA?

好，太棒了。所以他們沒有，只是為了再次確認他們不會以任何方式或某種方式影響 BLA，除了解決這些流程問題之外，我知道這些問題很重要，但他們沒有暗示——對 FDA 評估 BLA 的更廣泛影響？

Yes. I mean, I don't want to go so far as to speak on behalf of the FDA on that side. But yes, I mean these were not lots or batches that were included in our validation of our new working cell bank. These were sort of one-off observations related to drug substance, single drug substance lots that were development launched.

是的。我的意思是，我不想在那邊代表 FDA 發言。但是，是的，我的意思是這些不是我們對新工作細胞庫的驗證中包含的批次。這些是與原料藥相關的一次性觀察，即開發中的單一原料藥批次。

Okay, great. And again, wasn't far enough to speak for the FDA and I understand that sensitivity. And then just maybe stepping back, I just want to -- congrats on the performance of the RHA line. You know, your key competitor in the filler market didn't have nearly as good performance in the second quarter. You were up I think 22% sequentially and they were sort of down meaningfully on a year-on-year basis. So I'm just curious if you saw anything in the market. I know there has been some concerns about the sort of macro environment just given the broader sort of an economic environment. I was just curious if you saw anything, is there anything that might have spoken to what your largest competitor saw?

好，太棒了。再一次，不足以代表 FDA 發言，我理解這種敏感性。然後也許退後一步，我只是想 - 祝賀 RHA 產品線的表現。您知道，您在填料市場的主要競爭對手在第二季度的表現幾乎沒有那麼好。我認為您連續上漲了 22%，並且同比下降了一些。所以我很好奇你是否在市場上看到了什麼。我知道，考慮到更廣泛的經濟環境，人們對這種宏觀環境存在一些擔憂。我只是好奇你是否看到了什麼，有沒有什麼可以和你最大的競爭對手看到的有什麼關係？

I'll head it to the beginning and then hand it over to Dustin if he's got any additional color to add. I'd say that really again we're in launch phase to really are mean sort of focus is finding accounts that are willing to sort of try and evaluate RHA filler line and then obviously trying to drive deeper kind of fit penetration in those accounts and we're doing that through training and education, peer influencers that are sharing their experiences and outcomes. And I think with the methodical approach that we've taken, we're seeing nice uptake.

如果他有任何額外的顏色要添加，我會從頭開始，然後把它交給達斯汀。我想說的是，我們真的再次處於啟動階段，真正的重點是尋找願意嘗試和評估 RHA 填充線的客戶，然後顯然試圖在這些客戶中推動更深層次的適合滲透和我們通過培訓和教育來做到這一點，同行有影響力的人分享他們的經驗和成果。而且我認為通過我們採取的有條不紊的方法，我們看到了很好的吸收。

RHA Collection is a great collection. So I think you're seeing it as a product line that adding something that's incremental to what they have due to sort of the natural way that the product moves there. And I also think it's a reflection of the strategy that we've taken.

RHA Collection 是一個很棒的收藏。因此，我認為您將其視為一條產品線，由於產品移動到那裡的自然方式，它添加了一些與現有產品相比有所增加的東西。我也認為這反映了我們所採取的策略。

We've taken a very deliberate strategy focused on prestige accounts, where we've got transparent pricing, we're trying to help make sure that they're getting the right outcomes and that this is a profitable and value-added service for us. And so, we did in the quarter, we just sort of steady issue goes, continuing to drive more account growth in a little bit deeper penetration. But Dustin, I don't know if you want to add anything to that?

我們採取了一個非常謹慎的策略，專注於信譽賬戶，我們有透明的定價，我們正在努力幫助確保他們獲得正確的結果，這對我們來說是一項有利可圖的增值服務.因此，我們在本季度做了，我們只是有點穩定的問題，繼續以更深的滲透率推動更多的賬戶增長。但是達斯汀，我不知道你是否想補充什麼？

So I think you hit the fact that it's a differentiated strategy not built around couponing and not built around programs at certain point in time. I think you heard the commentary from that organization around how they had program in certain time to drive certain behaviors and we have built our business on this product being uniquely formulated, uniquely adding value to both the injector and the consumer. And we're going to continue to leverage that. And so, we've got a nice opportunity in front of us with 4 different SKUs that allows us to go deeper into accounts, but also as Mark mentioned, we've got an opportunity to expand our account base.

因此，我認為您遇到了這樣一個事實，即這是一種差異化策略，不是圍繞優惠券建立的，也不是圍繞特定時間點的計劃建立的。我想你聽到了該組織關於他們如何在特定時間制定程序來推動特定行為的評論，我們的業務建立在這種產品的獨特配方上，為註射器和消費者帶來獨特的增值。我們將繼續利用這一點。因此，我們面前有一個很好的機會，有 4 個不同的 SKU 可以讓我們更深入地了解帳戶，而且正如 Mark 所提到的，我們有機會擴大我們的帳戶基礎。

So we're in a very unique and different position in some of those competitors and we feel good about that employees continue to leverage that. And so, we've got a nice opportunity in front of us with 4 different SKUs that allows us to go deeper into accounts. But also as Mark mentioned, we've got an opportunity to expand our account base. So we're in a very unique and different position in some of those competitors and we feel good about that and poised to launch the portfolio.

因此，我們在其中一些競爭對手中處於非常獨特和不同的位置，我們對員工繼續利用這一點感到滿意。因此，我們面前有一個很好的機會，有 4 個不同的 SKU，可以讓我們更深入地了解帳戶。但正如馬克所提到的，我們有機會擴大我們的客戶群。因此，我們在其中一些競爭對手中處於非常獨特和不同的位置，我們對此感覺良好，並準備推出該產品組合。

Congratulations on the progress.

祝賀取得進展。

And your last question comes from the line of Serge Belanger from Needham & Company.

您的最後一個問題來自 Needham & Company 的 Serge Belanger。

I guess I'll get in on the topic is your -- in terms of new Form 483 observations, Now that you've submitted your responses, are you expecting any kind of feedback from the FDA if they close the issues out or provide additional suggestive actions to rectify these observations?

我想我要討論的主題是你的——就新的 483 表意見而言，既然你已經提交了你的回复，你是否期待 FDA 的任何形式的反饋，如果他們關閉問題或提供額外的糾正這些意見的建議性行動？

It's certainly possible we could hear something back. At this point, we've not heard anything back. We provided our comprehensive responses to the agency and it's quite likely that we won't hear anything back other than sort of their final decision on the PDUFA date.

我們當然有可能聽到回音。在這一點上，我們還沒有收到任何回复。我們向該機構提供了全面的回复，除了他們對 PDUFA 日期的最終決定之外，我們很可能不會聽到任何回复。

And if you hear some back would that be something you would disclose or it depends on the nature of the response?

如果你聽到一些回复，那是你會透露的，還是取決於回應的性質？

Yes. I mean, I think you say never again, our bias is towards not providing ongoing interaction with the agency could imagine there is a variety of flavors at that takes and that's our normal protocol. Unfortunately, had to break from that a few times due to the redacted Form 483 that were put out there in our awareness this morning that we would likely get another 483 put out there prior to our PDUFA date. So unless we thought it was something that significantly compromise our approvability, we would not be commenting on that.

是的。我的意思是，我想你再也不會說，我們的偏見是不提供與該機構的持續互動，可以想像有各種各樣的口味，這是我們的正常協議。不幸的是，由於今天早上我們意識到我們可能會在我們的 PDUFA 日期之前收到另一份 483 表，因此不得不放棄幾次。因此，除非我們認為這會嚴重影響我們的認可度，否則我們不會對此發表評論。

Okay, fair enough. And then just a broader market question. Based on the earnings reports of other toxin companies, this is a market that, at least in the last 2 or 3 quarters is significantly outpaced its usual high single-digit to low double-digit growth rates. Just curious how that changes your pricing in following strategies for DAXI?

好吧，夠公平的。然後只是一個更廣泛的市場問題。根據其他毒素公司的收益報告，這是一個至少在過去 2 或 3 個季度顯著超過其通常的高個位數至低兩位數增長率的市場。只是好奇這如何改變您在 DAXI 的以下策略中的定價？

Yes. Serge, this is Dustin. I think, first side, right. The more growth, the more opportunities for all players here especially one that has the first innovation in 30 years. And so we feel really good about our capitalization on that opportunity. And in any market, especially when that's growing, innovation comes at a premium. And so we feel good about our pricing strategy. We feel good about both is the premium opportunity that we have in launching something. This innovation that provides value to both the injector and the consumers.

是的。塞爾吉，這是達斯汀。我認為，第一方面，對。增長越多，這裡所有參與者的機會就越多，尤其是 30 年來首次創新的參與者。因此，我們對利用這個機會感到非常滿意。在任何市場中，尤其是在市場增長的情況下，創新都是非常寶貴的。所以我們對我們的定價策略感覺很好。我們對兩者都感覺良好，這是我們推出某些東西的絕佳機會。這項創新為噴油器和消費者提供了價值。

So I don't think anything we've seen really kind of changes our launch strategy today just the more the merrier, we're happy that the market continues to grow and we look forward to capitalize on that.

因此，我認為我們今天看到的任何事情都不會真正改變我們今天的發布策略，越多越好，我們很高興市場繼續增長，我們期待著利用這一點。

Got it. One last one, you talked about your plans to submit the sBLA for cervical dystonia. But what about plans to re-initiate development of other therapeutic indications, upper limb spasticity is the obvious one. But you know on the past, you've also talked about migraine indication?

知道了。最後一個，您談到了您為頸肌張力障礙提交 sBLA 的計劃。但是，如果計劃重新啟動其他治療適應症的開發，上肢痙攣是顯而易見的。但是你知道過去，你也談到過偏頭痛的跡象嗎？

Yes. Serge, I think, we want to get through approval and into the market and then revisit that based on sort of our capital allocation and sort of where we want to focus our dollars. But clearly, the be filing our sBLA for cervical dystonia will represent our first foray into therapeutic. And more particularly, the muscle movement disorder category, which is sizable and we're encouraged about that.

是的。 Serge，我認為，我們希望獲得批准並進入市場，然後根據我們的資本配置和我們想要集中資金的地方重新審視它。但顯然，提交我們的 sBLA 治療頸肌張力障礙將代表我們首次涉足治療領域。更具體地說，肌肉運動障礙類別相當大，我們對此感到鼓舞。

So I think about this is that these are markets that continue to grow and expand and we believe that the promise of a long-acting neuromodulator in the category will still resonate over time and so we'll get back to you. We feel we've got more clarity around what's the right time to advance the therapeutic program beyond cervical dystonia.

因此，我認為這些市場將繼續增長和擴大，我們相信該類別中長效神經調節劑的承諾仍會隨著時間的推移而引起共鳴，因此我們會回复您。我們覺得我們已經更清楚地知道什麼是推進治療計劃超越頸肌張力障礙的正確時機。

This ends our Q&A session and today's conference call. Thank you for your participation. You may disconnect at this time. Goodbye.

我們的問答環節和今天的電話會議到此結束。感謝您的參與。此時您可以斷開連接。再見。