Arcutis Biotherapeutics Inc (ARQT) 2025 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Arcutis Biotherapeutics 2025 second quarter financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker, Brian Schoelkopf, Head of Investor Relations. Please go ahead.

您好，感謝您的支持。歡迎參加 Arcutis Biotherapeutics 2025 年第二季財務業績電話會議。（操作員指示）請注意，今天的會議正在錄音。現在，我想將會議交給第一位發言人，投資者關係主管 Brian Schoelkopf。請繼續。

Thank you, Michelle. Good afternoon, everyone, and thank you for joining us today to review our second quarter 2025 financial results and business update. Slides for today's call are available on the Investors section of the Arcutis website.

謝謝你，米歇爾。大家下午好，感謝您今天加入我們，回顧我們 2025 年第二季的財務表現和業務更新。今日電話會議的幻燈片可在 Arcutis 網站的「投資者」部分找到。

On the call today are Frank Watanabe, President and CEO; Patrick Burnett, Chief Medical Officer; Todd Edwards, Chief Commercial Officer; and Latha Vairavan, Chief Financial Officer.

參加今天電話會議的有總裁兼執行長 Frank Watanabe、首席醫療官 Patrick Burnett、首席商務官 Todd Edwards 和財務長 Latha Vairavan。

I would like to remind everyone that we will be making forward-looking statements during this call. These statements are subject to certain risks and uncertainties, and our actual results may differ. We encourage you to review all of the company's filings with the Securities and Exchange Commission, including descriptions of our business and risk factors. With that, let me hand the call over to Frank.

我想提醒大家，我們將在本次電話會議中做出前瞻性陳述。這些聲明受一定風險和不確定性的影響，我們的實際結果可能有所不同。我們鼓勵您查看公司向美國證券交易委員會提交的所有文件，包括我們的業務和風險因素的描述。說完這些，讓我把電話交給法蘭克。

Thanks, Brian, and thank you to everyone for joining us today. I'm pleased to report that in the second quarter, we continued to see strong sales and demand growth with our ZORYVE franchise, demonstrating continued adoption by health care providers and patients and consistent execution by our commercial team.

謝謝，布萊恩，也謝謝大家今天加入我們。我很高興地報告，在第二季度，我們的 ZORYVE 特許經營權繼續保持強勁的銷售和需求成長，表明醫療保健提供者和患者的持續採用以及我們的商業團隊的一致執行。

During today's call, we will review in detail the results for the quarter, but we'll also spend time talking in more depth about our plans to sustain our growth into the future, including the next wave of growth for ZORYVE, how we intend to leverage our best-in-class development and commercialization capabilities to address the unmet urgent needs of patients living with immune-mediated dermatologic diseases and our capital allocation framework to enable this next growth phase.

在今天的電話會議中，我們將詳細回顧本季度的業績，但我們也將花時間更深入地討論我們未來維持增長的計劃，包括 ZORYVE 的下一波增長，我們打算如何利用我們一流的開發和商業化能力來滿足免疫介導皮膚病患者未滿足的緊急需求，以及我們的資本配置框架來實現下一階段的增長。

Before I dive in, I want to thank the exceptional team at Arcutis that is dedicated to and instrumental in advancing our efforts to serve the needs of people living with serious skin diseases.

在深入探討之前，我想感謝 Arcutis 的優秀團隊，他們致力於並幫助我們努力滿足患有嚴重皮膚病的人的需求。

So on slide 5, honing in on the second quarter, we saw another quarter of strong revenue growth as patients and clinicians continue to adopt ZORYVE for the treatment of a range of inflammatory dermatosis. For the quarter, we reported net product revenues of $81.5 million, representing 28% quarter-on-quarter growth and 164% growth compared to the same quarter 2024. This substantial sequential growth reflects the continuously increasing demand for ZORYVE with TRx volume increasing for all products.

因此，在第 5 張幻燈片中，我們回顧第二季度，看到隨著患者和臨床醫生繼續採用 ZORYVE 治療一系列發炎性皮膚病，我們迎來了一個強勁的收入增長季度。本季度，我們報告的淨產品收入為 8,150 萬美元，較上季成長 28%，與 2024 年同期相比成長 164%。這一大幅連續增長反映了對 ZORYVE 的需求不斷增長，所有產品的 TRx 數量都在增加。

In May, we received approval from the FDA for the use of ZORYVE foam 0.3% for the treatment of plaque psoriasis of the scalp and body, our fifth FDA approval for ZORYVE in the last three years. We believe this new indication for our foam will provide an important and much-needed new treatment option for the over half of plaque psoriasis patients who have scalp involvement.

5 月份，我們獲得了 FDA 批准使用 0.3% ZORYVE 泡沫治療頭皮和身體的斑塊性乾癬，這是我們三年來第五次獲得 FDA 對 ZORYVE 的批准。我們相信，我們泡沫的這種新適應症將為超過一半的頭皮受累的斑塊狀銀屑病患者提供重要且急需的新治療選擇。

In the quarter, we continue to make progress against a core objective that is the progressive conversion of topical steroid prescriptions to ZORYVE. We see growing evidence that dermatology clinicians are appreciating the risks associated with extended steroid use and as such, are increasing their use of alternative nonsteroid topical agents.

本季度，我們繼續朝著核心目標邁進，即逐步將外用類固醇處方轉換為 ZORYVE。我們看到越來越多的證據表明，皮膚科臨床醫生意識到長期使用類固醇的風險，因此，他們正在增加使用替代非類固醇外用藥物。

We also saw strengthening in our business fundamentals in the second quarter. As we continue to grow ZORYVE sales while remaining disciplined with our expense base, we are increasing our operating leverage. Latha will go into more detail on our operating results and improving cash burn profile.

我們也看到第二季我們的業務基本面有所加強。隨著我們繼續增加 ZORYVE 的銷售額，同時嚴格控制開支基礎，我們的營運槓桿也不斷提高。Latha 將更詳細地介紹我們的經營業績和改善現金消耗狀況。

As we progress towards reaching cash flow breakeven in 2026, we are rapidly approaching a point where we will have additional resources to invest in future growth. And today, we will begin to lay out our plans, including the next wave of ZORYVE expansion, additional pipeline opportunities and our disciplined capital allocation strategy that underpins it all. Okay.

隨著我們逐步實現 2026 年現金流收支平衡，我們很快就能擁有更多資源來投資未來成長。今天，我們將開始製定計劃，包括下一波 ZORYVE 擴張、額外的管道機會以及支撐這一切的嚴謹的資本配置策略。好的。

Turning now to slide 6. We have been intently focused on clinical, regulatory and commercial execution for ZORYVE over the last several years as evidenced by our results. And so as I introduce our framework for near, medium and long-term growth today, I will start by saying that we will continue to see substantial opportunities for sales and profit expansion from our current ZORYVE indications and those in late-stage development.

現在翻到幻燈片 6。我們的成果證明了，過去幾年我們一直專注於 ZORYVE 的臨床、監管和商業執行。因此，當我今天介紹我們的近期、中期和長期成長框架時，我首先要說的是，我們將繼續從目前的 ZORYVE 適應症和後期開發中看到巨大的銷售和利潤擴張機會。

While non-steroidal topicals are making inroads in the treatment of immune-mediated inflammatory skin diseases, there is still a tremendous amount of potential conversion to be had. As patients and prescribers continue to understand how ZORYVE can serve as the foundational long-term therapy for psoriasis, atopic dermatitis and seborrheic dermatitis, topical steroids will increasingly be reserved for acute treatment.

儘管非類固醇用藥物在免疫介導發炎性皮膚病的治療中取得了進展，但仍有大量的潛在轉化空間。隨著患者和處方者不斷了解 ZORYVE 如何作為牛皮癬、異位性皮膚炎和脂漏性皮膚炎的基礎長期治療，外用類固醇將越來越多地用於急性治療。

To dimensionalize the size of this opportunity, last year, over 69% of all topical prescriptions in our approved indications were written for steroids. So the progressive conversion from steroids will be a sustainable growth driver for ZORYVE for many years to come. Our expected label expansion for pediatric atopic dermatitis and development efforts for infant AD, which Patrick will further detail shortly, will be another component of this continued growth.

為了具體說明這個機會的規模，去年，我們批准的所有外用處方中超過 69% 都是針對類固醇的。因此，類固醇的逐步轉換將成為未來許多年 ZORYVE 永續成長的動力。我們預計將擴大兒童異位性皮膚炎的標籤範圍，並努力開發嬰兒異位性皮膚炎，帕特里克將在稍後詳細介紹，這將是這一持續增長的另一個組成部分。

Other commercial opportunities such as further access improvements and the development of the PCP and pediatric channel that we previously detailed will also support our continued momentum with ZORYVE. These cumulative near-term opportunities will power ZORYVE growth throughout 2025, 2026 and beyond.

其他商業機會，例如進一步改善訪問以及我們先前詳述的 PCP 和兒科管道的開發，也將支持我們與 ZORYVE 繼續保持發展勢頭。這些累積的近期機會將推動 ZORYVE 在 2025 年、2026 年及以後的成長。

Beyond our current ZORYVE portfolio, we see a next wave of growth being driven by effective and efficient life cycle management for the ZORYVE franchise. This has been enabled by the various formulations and concentrations available for ZORYVE, which has, in essence, create a Swiss Army knife for inflammatory skin conditions. Patrick will expand on our approach to ZORYVE life cycle management, but I will highlight that a core principle is to be data-driven and disciplined, matching investment to clinical promise and opportunity size.

除了我們目前的 ZORYVE 產品組合之外，我們還看到下一波成長將由 ZORYVE 特許經營的有效和高效的生命週期管理所推動。這是因為 ZORYVE 擁有多種配方和濃度，從本質上來說，它就是一把治療發炎性皮膚病的瑞士軍刀。派崔克將詳細說明我們對 ZORYVE 生命週期管理的方法，但我要強調的是，核心原則是以數據為導向並遵循紀律，將投資與臨床前景和機會規模相匹配。

Longer term, our current development pipeline shows promise in addressing areas of high unmet needs for these patients. We will also continue to evaluate external sources of innovation based on our conviction that our core competencies gives us the ability to leverage the research and early development efforts of other companies and to drive those innovations through later stages of development, regulatory approval and commercialization.

從長遠來看，我們目前的開發管道有望解決這些患者尚未滿足的巨大需求。我們也將繼續評估外部創新來源，因為我們堅信，我們的核心競爭力使我們能夠利用其他公司的研究和早期開發成果，並推動這些創新進入後期開發、監管部門批准和商業化階段。

We are at an exciting point at Arcutis, approaching profitability that will underwrite both the next stage of expansion for the ZORYVE franchise and subsequent waves of innovation. And while we are eager to apply our expertise in dermatological development and commercialization, I will again underscore that we will continue to be thoughtful and disciplined in our deployment of capital.

Arcutis 正處於一個激動人心的時刻，即將實現盈利，這將為 ZORYVE 特許經營的下一階段擴張和後續的創新浪潮提供保障。雖然我們渴望將我們的專業知識應用於皮膚病學開發和商業化，但我要再次強調，我們將繼續在資本配置方面深思熟慮並保持紀律。

We will continue to be stringent in our internal capital allocation by being data-driven in our pipeline management decisions. As you will hear from Patrick shortly in that vein, we have made the difficult decision to halt the development of ARQ-255 following the readout from our Phase Ib trial.

我們將繼續嚴格執行內部資本配置，並在管道管理決策中以數據為驅動力。正如您很快就會從帕特里克口中聽到的那樣，我們在第一階段試驗的結果出來後做出了艱難的決定，停止 ARQ-255 的開發。

Finally, in the context of these promising opportunities for capital deployment, I will reaffirm that we are committed to generating positive free cash flow. We remain on track to achieve this milestone with our current business in 2026.

最後，在這些充滿希望的資本配置機會的背景下，我重申我們致力於創造正的自由現金流。我們仍有望在 2026 年憑藉現有業務實現這一里程碑。

It is our intention that future clinical development spend to advance our existing pipeline will be funded by cash flows from our ZORYVE franchise, although we do acknowledge that a potential acquisition of some external innovation might require incremental capital.

我們的意圖是，未來用於推進現有產品線的臨床開發支出將由我們的 ZORYVE 特許經營權的現金流資助，儘管我們承認，對一些外部創新的潛在收購可能需要增量資本。

Okay. On slide 7, I want to take just a minute to expand on why we believe that pursuing further label expansion for ZORYVE is a smart investment and a judicious use of our capital. First, as one of the most successful drug franchises of all time, the story of HUMIRA's incredible success is well known. But the details of how that success was achieved, in particular, the steady indication expansion for the franchise provides a sense of the power of a well-executed life cycle management program.

好的。在第 7 張投影片上，我想花一點時間來詳細說明為什麼我們認為進一步擴大 ZORYVE 的品牌規模是一項明智的投資，也是對我們資本的明智使用。首先，作為有史以來最成功的藥品特許經營之一，HUMIRA 的驚人成功故事眾所周知。但成功實現的細節，特別是特許經營的穩定擴張，讓人感受到執行良好的生命週期管理計畫的力量。

HUMIRA first launched in 2022 with initial indication in rheumatoid arthritis, which produced the majority of the brand's early revenues. But as we can see in the chart on the left-hand side of the slide, it was not only the growth of that indication that powered HUMIRA's success, but also the consistent addition of new indications and label expansions. And by the time HUMIRA reached its peak sales in 2022, AbbVie had added 11 indications for this drug and fully 68% of sales were derived from indications beyond rheumatoid arthritis.

HUMIRA 於 2022 年首次推出，最初用於治療類風濕性關節炎，這為該品牌的早期收入貢獻了大部分。但正如我們在投影片左側的圖表中所看到的，推動 HUMIRA 成功的不僅是該適應症的成長，還有新適應症的不斷增加和標籤的擴展。而到 2022 年 HUMIRA 銷售達到頂峰時，艾伯維已為該藥物增加了 11 種適應症，並且 68% 的銷售額均來自類風濕性關節炎以外的適應症。

A more recent and developing example of effective life cycle management can be found in Sanofi and Regeneron's Dupixent. Dupixent launched in 2017 with an initial indication of adult atopic dermatitis. Since 2018, 10 additional indications for the brand have been approved. While atopic dermatitis remains the most significant revenue driver, accounting for about 74% of sales as of 2024, approximately $3.7 billion in sales was generated by these subsequently added indications such as asthma and nasal polyps.

賽諾菲 (Sanofi) 和再生元 (Regeneron) 的 Dupixent 是有效生命週期管理的一個較新且正在發展的例子。Dupixent 於 2017 年上市，最初用於治療成人異位性皮膚炎。自 2018 年以來，該品牌又有 10 項適應症獲得批准。雖然異位性皮膚炎仍然是最重要的收入驅動因素，截至 2024 年約佔銷售額的 74%，但隨後增加的氣喘和鼻息肉等適應症創造了約 37 億美元的銷售額。

The progressive expansion of our label for ZORYVE is not a new story either. Since launching in adult plaque psoriasis in 2022, we've expanded to cover three diseases and won four label expansions. In the second quarter, the sales contribution from these new indications and label expansion exceeded two-thirds of our total sales. And it is our strong belief that continued pursuit of new patient populations who may benefit from ZORYVE will sustain the brand's growth.

我們為 ZORYVE 品牌進行的逐步擴張也不是什麼新鮮事。自 2022 年推出成人斑塊狀乾癬治療產品以來，我們的產品範圍已擴大到涵蓋三種疾病，並獲得了四次標籤擴展。在第二季度，這些新適應症和標籤擴展帶來的銷售貢獻超過了我們總銷售額的三分之二。我們堅信，持續尋找可能受益於 ZORYVE 的新患者群體將維持該品牌的成長。

And with that, let me turn it over to Todd to provide some more color on the quarter. Todd?

接下來，請容許我把時間交給托德，讓他為本季提供更多細節。托德？

Thank you, Frank. I'm on slide 9. In the second quarter, we achieved $81.5 million in net product revenue for ZORYVE, reflecting 164% growth year-over-year and sequential growth of 28% compared to the first quarter. Importantly, growth during this period was driven by increased demand across all strengths and indications. highlighting the robust performance of the franchise and the continued adoption of ZORYVE across its approved indications.

謝謝你，弗蘭克。我在第 9 張投影片。第二季度，ZORYVE 的淨產品收入達到 8,150 萬美元，年增 164%，季增 28%。重要的是，這一時期的增長是由所有強度和適應症的需求增長推動的，突顯了特許經營的強勁表現以及 ZORYVE 在其獲批適應症中的持續採用。

The meaningful revenue expansion in the quarter was a result of strong volume growth supported by stable gross to net rates ZORYVE, driven by the high percentage of prescriptions being reimbursed. An additional factor driving product revenue growth in the quarter was the recovery of inventory levels in our distribution channels back to normal levels following a drawdown in the first quarter.

本季營收的顯著成長得益於強勁的銷售成長，這得益於 ZORYVE 穩定的毛利率和淨利率，而這又得益於高比例的處方報銷。推動本季產品收入成長的另一個因素是，我們的分銷管道的庫存水準在第一季下降之後恢復到正常水準。

Looking ahead to the remainder of 2025, we anticipate steady sales growth driven by new indication launches, increased contribution from the PCP and pediatric channel through our partnership with COA and continued share gains in a sizable topical market, primarily coming from steroid conversion.

展望 2025 年剩餘時間，我們預計銷售額將穩步增長，這得益於新適應症的推出、透過與 COA 合作增加 PCP 和兒科通路的貢獻以及在相當大的外用市場的持續份額增長（主要來自類固醇轉化）。

That said, ZORYVE is not exempt from the seasonality that typically affects prescription topical products. As a result, we anticipate a moderation in our sequential growth rate in the third quarter before returning to robust growth in the fourth quarter. I'll provide additional detail on this shortly.

話雖如此，ZORYVE 也不能免受通常影響處方外用產品的季節性影響。因此，我們預計第三季的環比成長率將放緩，然後在第四季恢復強勁成長。我很快就會提供更多詳細資訊。

As shown on slide 10, ZORYVE prescription volume reached a record high of 16,000 weekly scripts on a rolling 4-week average basis. The nearly 200,000 total prescriptions in the quarter reflect a year-over-year volume increase of 117% and a quarter-over-quarter increase of 13%.

如投影片 10 所示，ZORYVE 的處方量在連續 4 週的平均值上達到了每週 16,000 份的歷史新高。本季處方總數接近 20 萬張，年增 117%，季增 13%。

This strong performance is enabled by the substantial breadth of adoption across prescribers with over 18,000 health care providers have written prescriptions in the second quarter and 26,000 since launch. This quarterly figure represents a 7% increase in the number of total prescriptions quarter-over-quarter and nearly 70% increase year-over-year.

這一強勁表現得益於處方醫生的廣泛採用，第二季度已有超過 18,000 名醫療保健提供者開出了處方，自推出以來已有 26,000 名開出了處方。本季數據顯示，處方總數較上季成長 7%，年增近 70%。

We continue to see an erosion of topical steroid share within the topical market. In Q2 2025, branded non-steroidal volume grew by 40% versus prior year, while topical steroid volume was effectively flat. ZORYVE is playing a key role in driving the shift as prescribers continue to appreciate its potential for sustained treatment of chronic inflammatory skin conditions compared to the intermittent use of that is appropriate with topical steroids.

我們持續看到外用類固醇在外用市場的份額不斷下降。2025 年第二季度，品牌非類固醇類藥物銷量較上年增長 40%，而外用類固醇藥物銷量則基本持平。ZORYVE 在推動這一轉變中發揮關鍵作用，因為與間歇性使用局部類固醇相比，處方醫生繼續認識到其對慢性發炎性皮膚病的持續治療潛力。

We are in the early stages of launching ZORYVE foam 0.3% for patients with scalp and body psoriasis following FDA approval in May. We expect this launch, along with the anticipated approval of ZORYVE cream 0.05% for patients aged two- to five years old in October to drive further volume growth in the second half of this year.

繼 5 月獲得 FDA 批准後，我們正處於推出 0.3% ZORYVE 泡沫的早期階段，該產品可用於治療頭皮和身體牛皮癬患者。我們預計，此次產品的上市，以及預計於 10 月批准的適用於 2 至 5 歲患者的 0.05% ZORYVE 乳膏，將推動今年下半年銷售的進一步成長。

While we continue to expect strong overall growth for ZORYVE in 2025, including in the third quarter, the pace of growth in Q3 will reflect the typical seasonality of the topical market. This is influenced by nonmedical factors such as summer vacations and medical factors, including reduced flaring of inflammatory skin conditions during the summer months. As a result, we anticipate some moderation of growth in Q3 before returning to a more robust trajectory in Q4.

雖然我們繼續預期 ZORYVE 在 2025 年（包括第三季）將實現強勁的整體成長，但第三季的成長速度將反映出外用市場的典型季節性。這是受到非醫療因素（例如暑假）和醫療因素（包括夏季發炎性皮膚病發作減少）的影響。因此，我們預計第三季經濟成長將放緩，然後在第四季度恢復更強勁的軌跡。

Let's now turn to our recent approval for ZORYVE on slide 11. In May, we received FDA approval for ZORYVE foam 0.3% for the treatment of plaque psoriasis for scalp and body. As Frank mentioned, more than half of plaque psoriasis patients have scalp involvement. Historically, these patients have managed their condition with a combination of topical steroids and other treatments, depending on plaque location, resulting in a frustrating polypharmacy approach.

現在讓我們來看看第 11 張投影片上我們最近對 ZORYVE 的批准。5 月份，我們獲得 FDA 批准，可使用 0.3% ZORYVE 泡沫治療頭皮和身體的斑塊性乾癬。正如弗蘭克所提到的，超過一半的斑塊狀乾癬患者的頭皮受到影響。從歷史上看，這些患者根據斑塊的位置採用外用類固醇和其他治療方法相結合的方式來控制病情，從而導致令人沮喪的多藥物治療。

The ability to use a single product once daily across all affected areas offers a meaningful reduction in treatment burden. ZORYVE foam 0.3% delivers reliable plaque clearance and rapid itch relief in a formulation specifically designed for hair-bearing areas and appropriate for use near the eyes and other sensitive areas.

每天只需使用一種產品覆蓋所有受影響區域一次，即可顯著減輕治療負擔。ZORYVE 泡棉 0.3% 提供可靠的牙菌斑清除和快速止癢效果，其配方專為毛髮區域設計，適合在眼睛附近和其他敏感區域使用。

We are confident this label expansion will drive incremental demand for ZORYVE, particularly as the foam displaces other treatment options for scalp psoriasis. Since the foam formulation for Seb derm and psoriasis are on the same SKU across both indications, it will take additional time to accumulate sufficient longitudinal data to accurately parse out contributions by disease.

我們相信，此次標籤擴展將推動對 ZORYVE 的需求增加，特別是當泡沫取代頭皮牛皮癬的其他治療方案時。由於脂漏性皮膚炎和牛皮癬的泡沫製劑在兩種適應症中都屬於同一 SKU，因此需要更多時間來累積足夠的縱向數據，以準確分析出疾病的貢獻。

However, we have seen an acceleration in foam growth with a 9% increase in volume in the 6 weeks since launch compared to the prior 6 weeks. As previously noted, our analysis indicates that clinicians who prescribe ZORYVE across multiple indications tend to generate significantly higher prescription volumes overall as they recognize the meaningful disease management benefits ZORYVE delivers for patients. With the introduction of ZORYVE foam for this new indication, we expect this effect to compound further.

然而，我們看到泡沫成長加速，與前 6 週相比，自推出以來的 6 週內泡沫體積增加了 9%。如前所述，我們的分析表明，在多種適應症中開出 ZORYVE 的臨床醫生往往會產生更高的處方量，因為他們認識到 ZORYVE 為患者帶來的有意義的疾病管理益處。隨著 ZORYVE 泡沫針對這項新適應症的推出，我們預計這種效果將進一步增強。

Moving to slide 12. A long-standing objective at Arcutis has been to drive reimbursed prescriptions, not just any prescriptions as they directly impact top line revenue. We continue to benefit from strong insurance coverage for ZORYVE across approved indications with approximately 80% of all prescriptions being reimbursed. This favorable coverage landscape supported the revenue growth achieved during the quarter with gross to net rates remaining stable.

移至投影片 12。Arcutis 的一個長期目標是推動報銷處方，而不是任何處方，因為它們直接影響營業收入。我們繼續受益於 ZORYVE 在核准適應症方面的強大保險覆蓋，其中約 80% 的處方可獲得報銷。這種良好的覆蓋前景支持了本季實現的收入成長，總淨利率保持穩定。

We also made meaningful progress with Medicaid with well over half of all Medicaid recipients now having access to ZORYVE and the majority of covered lives only require a single step through a steroid. This advancement contributed to strong quarter-over-quarter unit growth from the Medicaid channel.

我們在醫療補助方面也取得了有意義的進展，現在超過一半的醫療補助受益人可以使用 ZORYVE，並且大多數受保人只需使用類固醇即可獲得治療。這項進步促進了醫療補助管道單位數量的環比強勁增長。

We remain actively engaged in negotiations with Medicare Part D plans and are committed to expand access for these patients even as payers continue to navigate financial disruptions due to the implementation of the Inflation Reduction Act. The IRA introduced changes to the Part D benefit structure, including a shift in cost sharing responsibilities between CMS, Part D plans and manufacturers.

我們仍然積極參與與 Medicare D 部分計劃的談判，並致力於擴大這些患者的就醫機會，即使付款人繼續因《通貨膨脹削減法案》的實施而面臨財務混亂。IRA 對 D 部分福利結構進行了修改，包括 CMS、D 部分計劃和製造商之間的成本分攤責任的轉變。

These changes are creating both operational and financial complexities for Part D plans as they work to update their systems, adjust risk models and align on formulary strategies. This environment has led to a more protracted process to cover decisions for all new pharmaceuticals.

這些變化為 D 部分計劃帶來了營運和財務上的複雜性，因為它們需要更新系統、調整風險模型並調整處方集策略。這種環境導致所有新藥的決策過程變得更加漫長。

Moving to slide 13. The expanded utilization of ZORYVE in the primary care and pediatric setting remains a key component of our growth strategy, and we continue to make progress through our partnership with Kowa. From the outset, we recognize that the primary care selling cycle requires more frequent and sustained engagement to build familiarity. Many providers in this setting have limited exposure to topical nonsteroid treatments and tend to default to prescribing steroids.

移至幻燈片 13。ZORYVE 在初級保健和兒科環境中的擴大利用仍然是我們成長策略的關鍵組成部分，我們將繼續透過與 Kowa 的合作取得進展。從一開始，我們就認識到初級保健銷售週期需要更頻繁、更持續的參與來建立熟悉度。在這種情況下，許多提供者很少接觸局部非類固醇治療，並且傾向於預設開立類固醇處方。

Kowa's field team continues to execute targeted high-frequency outreach to drive initial trial and ultimately, adoption of ZORYVE among these providers and their patients. This process will further be supported by recent enhancements made to streamline the prescribing and fulfillment experience of these providers.

Kowa 的現場團隊繼續執行有針對性的高頻外展活動，以推動初步試驗，並最終在這些提供者及其患者中採用 ZORYVE。近期採取的改進措施將進一步支持此流程，從而簡化這些提供者的處方和履行體驗。

In the second quarter, we implemented a dedicated national pharmacy with improved capabilities for this channel. This pharmacy will play a pivotal role in appropriately helping offices navigate the fulfillment process that is often less familiar to primary care providers compared to dermatologists who are more accustomed to prescribing branded topicals.

在第二季度，我們設立了專門的國家藥房，並提升了該管道的功能。這家藥局將在適當幫助診所完成履行流程方面發揮關鍵作用，與更習慣於開品牌外用藥的皮膚科醫生相比，初級保健提供者通常不太熟悉這一流程。

The key advantage of this new dedicated pharmacy is its ability to integrate directly with EHR systems, enabling seamless incorporation of ZORYVE prescribing into existing workflows. Given the diversity and volume of patients in primary care setting, tools that reduce administrative burden and streamline access are instrumental in driving broader adoption.

這家新專用藥房的主要優勢在於它能夠直接與 EHR 系統集成，從而能夠將 ZORYVE 處方無縫整合到現有的工作流程中。鑑於初級保健環境中患者的多樣性和數量，減少管理負擔和簡化訪問的工具對於推動更廣泛的採用至關重要。

I'm now on slide 14. The future of ZORYVE is incredibly bright. With multiple formulations and concentrations, we are equipping health care providers with the flexibility to meet patients where they are in their treatment journey by providing a treatment option suitable for long-term use and the ability to better support the management of chronic inflammatory skin conditions.

我現在在第 14 張投影片。ZORYVE 的未來無比光明。憑藉多種配方和濃度，我們為醫療保健提供者提供了靈活性，透過提供適合長期使用的治療選擇和更好地支持慢性發炎皮膚病管理的能力，滿足患者在治療過程中的不同需求。

This versatility, combined with ZORYVE's well-established efficacy and safety profile continues to reinforce its position as the most prescribed brand topical across three major inflammatory skin conditions. With that, I'll now turn the call over to Patrick for an update on R&D.

這種多功能性，加上 ZORYVE 成熟的功效和安全性，繼續鞏固了其作為治療三大發炎性皮膚病最常用的品牌外用藥的地位。說完這些，我現在將電話轉給派崔克，讓他介紹研發的最新進展。

Thanks, Todd. I'm on slide 16. In the quarter, as you come to expect from us, we made significant progress against our clinical and regulatory objectives as we received FDA approval for ZORYVE foam 0.3% for scalp and body plaque psoriasis, initiated our Phase II trial for ZORYVE cream 0.05% in infants with atopic dermatitis and submitted our IND application for ARQ-234 in atopic dermatitis.

謝謝，托德。我在第 16 張投影片。在本季度，正如您對我們的期望，我們在臨床和監管目標方面取得了重大進展，因為我們獲得了 FDA 批准，將 0.3% 的 ZORYVE 泡沫用於治療頭皮和身體斑塊性牛皮癬，啟動了針對患有特應性皮膚炎的嬰兒的 0.05% 的 ZORYVE IND 的 II 期試驗，並提交了 ARQ-2 4 IND IND 4 4 IND 4 4 IND 4 4 434 4 4 的 IND 4 特應

Today, I'll spend time describing our efforts in developing ZORYVE for pediatric AD patients, outlining our approach to ZORYVE life cycle management and give an update on ARQ-255.

今天，我將花時間介紹我們為兒童 AD 患者開發 ZORYVE 的努力，概述我們對 ZORYVE 生命週期管理的方法，並介紹 ARQ-255 的最新情況。

First, I want to acknowledge the important milestone that our IND submission for ARQ-234 represents. We continue to believe that CD200 receptor modulation has the potential to be a powerful mechanism for the control of atopic dermatitis and other inflammatory conditions. We further believe that as a fusion protein with high selectivity for CD200, ARQ-234 has the potential to be a class-leading program. We look forward to sharing more detail on this program at a later date.

首先，我要承認我們提交的 ARQ-234 IND 代表著重要的里程碑。我們仍然相信 CD200 受體調節有可能成為控制異位性皮膚炎和其他發炎狀況的強大機制。我們進一步相信，作為一種對 CD200 具有高選擇性的融合蛋白，ARQ-234 有潛力成為一流的專案。我們期待稍後分享有關該計劃的更多細節。

Turning now to slide 17. Unlike other inflammatory skin conditions, atopic dermatitis often presents at early ages for patients. Nearly 10 million children in the US are impacted by atopic dermatitis with roughly 60% developing symptoms in their first year of life. AD presents unique challenges in these younger age groups, not only because the skin is more sensitive, but also because the condition often covers a greater percentage of their total body surface area compared to adolescents and adults.

現在翻到第 17 張投影片。與其他發炎性皮膚病不同，異位性皮膚炎通常在患者早期就會出現。美國有近 1,000 萬名兒童患有異位性皮膚炎，其中約 60% 在出生第一年出現症狀。阿茲海默症對這些較年輕的年齡層來說意味著獨特的挑戰，這不僅是因為他們的皮膚更加敏感，而且與青少年和成年人相比，這種疾病通常覆蓋他們身體總表面積的更大比例。

Parents of these pediatric patients are highly sensitive to potential negative side effects of topical steroids. These concerns range from the impact of chronic steroid use on the child's growth and bone development to more immediate complications like application to the child's face or contact with the eyes and mouth can be difficult to control.

這些兒科患者的父母對外用類固醇的潛在負面副作用非常敏感。這些問題包括長期使用類固醇對兒童生長和骨骼發育的影響，以及更直接的併發症，例如塗抹在兒童臉上或接觸眼睛和嘴巴可能會難以控制。

Given the size of the patient population and the need for safer and more tolerable therapeutic intervention, we've been enthusiastically pursuing label expansion for ZORYVE to younger ages of atopic dermatitis patients where we see a great fit for the ZORYVE clinical profile.

考慮到患者群體的規模以及對更安全、更耐受的治療幹預的需求，我們一直積極尋求將 ZORYVE 的標籤擴展到更年輕的異位性皮膚炎患者，我們認為這非常適合 ZORYVE 的臨床特徵。

In February, we submitted our sNDA for ZORYVE cream 0.05% for the treatment of children aged two- to five years old with atopic dermatitis, population of roughly 1.8 million patients. The submission was supported by data from the INTEGUMENT-PED Phase III trial, which demonstrated efficacy and a safe and tolerable profile in this age group, highlighted by 39% of children treated with ZORYVE achieving a 75% improvement in EASI score, also called an EASI-75, and this was done in just 4 weeks.

2 月份，我們提交了 ZORYVE 0.05% 乳膏的 sNDA，用於治療 2 至 5 歲患有異位性皮膚炎的兒童，患者人數約為 180 萬人。此項申請得到了 INTEGUMENT-PED III 期試驗數據的支持，該試驗證明了該藥物在該年齡組中的有效性和安全性和耐受性，其中 39% 接受 ZORYVE 治療的兒童的 EASI 評分提高了 75%，也稱為 EASI-75，而這僅在 4 週內就完成了。

In June, we presented new results from the INTEGUMENT-OLE long-term open-label study that demonstrated children ages two- to five who achieved disease clearance and switched to a proactive twice-weekly application of ZORYVE cream 0.5% were on average, able to maintain disease control for 238 days or nearly 8 months without the need to return to daily dosing.

6 月份，我們公佈了 INTEGUMENT-OLE 長期開放標籤研究的新結果，該研究表明，2 至 5 歲的兒童在疾病痊癒後改為每週兩次主動使用 0.5% ZORYVE 乳膏，平均能夠維持疾病控制 238 天或近 8 個月，而無需恢復每日服藥。

And we believe that the potential to control AD without disease flares with less frequent dosing may be a particularly compelling benefit for patients in this age range and their caregivers and speaks to the differentiated profile of ZORYVE as a foundational treatment for chronic inflammatory skin conditions.

我們相信，以較低的給藥頻率控制 AD 而不引發疾病的潛力可能對這個年齡層的患者及其照護者特別有益，也體現了 ZORYVE 作為慢性發炎性皮膚病基礎治療的差異化優勢。

We look forward to our target PDUFA date for this application in October of this year. We're also actively pursuing development of ZORYVE cream 0.05% in patients ages 3- to 24 months and enrolled the first patient in the INTEGUMENT infant trial for this population in June.

我們期待今年 10 月該申請的 PDUFA 目標日期。我們也積極致力於開發適用於 3 至 24 個月大患者的 0.05% ZORYVE 乳膏，並於 6 月招募了針對該族群的 INTEGUMENT 嬰兒試驗的第一位患者。

We're seeing brisk enrollment in the trial, which confirms our belief that amongst these young, vulnerable atopic dermatitis patients, there is an acute desire for alternative treatments to current therapies, most of which are topical corticosteroids. Pursuing these potential expansions into younger AD patient populations delivers on a core principle for Arcutis to deliver innovation that solves everyday challenges that significantly impact the lives of patients and their families.

我們看到試驗的報名人數正在迅速增加，這證實了我們的信念：在這些年輕、脆弱的異位性皮膚炎患者中，他們迫切需要替代當前療法的治療方法，其中大多數是外用皮質類固醇。將這些潛在的擴展擴展到更年輕的 AD 患者群體，實現了 Arcutis 的核心原則，即提供創新，解決對患者及其家人的生活產生重大影響的日常挑戰。

Now moving on to slide 18. As Frank remarked at the beginning of this call, pursuing new patient populations that may benefit from ZORYVE has been a core tenet of our clinical development strategy. This is evidenced by the 4 label expansions we have secured across plaque psoriasis, seborrheic dermatitis and atopic dermatitis following our initial approval in 2022.

現在翻到第 18 張投影片。正如弗蘭克在本次電話會議開始時所說，尋找可能受益於 ZORYVE 的新患者群體一直是我們臨床發展策略的核心原則。我們從 2022 年首次獲得批准後，在斑塊狀乾癬、脂漏性皮膚炎和異位性皮膚炎領域獲得的 4 個標籤擴展就可以看出這一點。

We believe that there are additional skin diseases that may respond to and more patients who may benefit from ZORYVE. This belief is not only supported by our understanding of ZORYVE's broadly applicable anti-inflammatory and antipruritic properties, but also by our feedback we've received from health care providers in the field. As part of our obligation to sponsor, our medical team monitors this feedback.

我們相信，還會有更多皮膚病對 ZORYVE 有反應，也會有更多患者受益。這一信念不僅得到了我們對 ZORYVE 廣泛適用的抗炎和止癢特性的理解的支持，也得到了我們從該領域的醫療保健提供者那裡收到的反饋的支持。作為我們贊助義務的一部分，我們的醫療團隊會監控這些回饋。

To date, we've identified more than 40 case reports from clinicians who have used ZORYVE in a multitude of other inflammatory dermatosis and see signs of efficacy. These clinicians have experienced the safe, tolerable, versatile and effective profile of ZORYVE in their psoriasis, AD and seb derm patients and have chosen to investigate novel applications of the therapy. These case reports are listed on the left side of the slide and include many diseases, which are not well managed by topical steroids and therefore, present a challenge for dermatology providers.

迄今為止，我們已經從臨床醫生那裡獲得了 40 多份病例報告，這些臨床醫生使用 ZORYVE 治療多種其他發炎性皮膚病並看到了療效跡象。這些臨床醫生已經體驗到了 ZORYVE 在牛皮癬、阿茲海默症和脂漏性皮病患者的安全性、耐受性、多功能性和有效性，並選擇研究該療法的新應用。這些病例報告列在幻燈片的左側，其中包括許多無法透過局部類固醇很好控制的疾病，因此對皮膚科醫生來說是一個挑戰。

Our approach to assessing these potential opportunities is stepwise and resource efficient. As indications of interest come to light, we'll engage in a collaborative research, conducting Phase II proof-of-concept studies where appropriate to evaluate the degree of response and understand potential safety and efficacy. Based on the results of these initial studies, our analysis of the addressable patient population for a given disease and feedback received by regulatory agencies, we may then identify additional indications for which a registrational trial conducted by Arcutis is a prudent investment.

我們評估這些潛在機會的方法是逐步的並且資源高效。隨著興趣跡象的出現，我們將進行合作研究，在適當的情況下進行第二階段概念驗證研究，以評估反應程度並了解潛在的安全性和有效性。根據這些初步研究的結果、我們對特定疾病的目標患者群體的分析以及監管機構收到的反饋，我們可以確定其他適應症，對於這些適應症，Arcutis 進行的註冊試驗是一項審慎的投資。

We're already pursuing this strategy with efforts underway to begin enrolling Phase II studies in vitiligo and hidradenitis suppurativa, and we anticipate initiating additional Phase II proof-of-concept studies going forward. This evaluation of new indications and program planning will be comprehensive and evolve over time, and each project will be carefully assessed relative to potential return on investment. Our progress in this process is another topic that we plan to detail further at a future date.

我們已經在實施這項策略，並正在努力開始招募白斑症和化膿性汗腺炎的 II 期研究，並且我們預計將來啟動更多的 II 期概念驗證研究。對新適應症和專案規劃的評估將是全面的，並將隨著時間的推移而發展，每個專案都將根據潛在投資回報進行仔細評估。我們在過程中取得的進展是我們計劃在未來進一步詳述的另一個主題。

Now moving on to slide 19. As Frank mentioned in his remarks and as you've heard throughout this call, Arcutis is fortunate to have multiple opportunities for clinical investment to pave the way for our future growth. As we evaluate our current and future portfolio of clinical programs, we will continue to be data-driven and apply a high bar for advancement.

現在翻到第 19 張投影片。正如弗蘭克在演講中提到的以及大家在整個電話會議中所聽到的，Arcutis 很幸運能夠獲得多個臨床投資機會，為我們未來的發展鋪平道路。在評估我們目前和未來的臨床項目組合時，我們將繼續以數據為導向，並設定高標準的進步標準。

In line with this rigorous portfolio management approach, we've announced today our decision to halt further development of ARQ-255 following our review of the results from our Phase Ib trial. We've always known that the ARQ-255 program was a high-risk endeavor.

本著這種嚴格的投資組合管理方法，我們在審查了 Ib 階段試驗的結果後，今天宣布決定停止 ARQ-255 的進一步發展。我們一直都知道 ARQ-255 計畫是一項高風險的事業。

Multiple other topical JAK inhibitors had previously failed in alopecia areata, but preclinical studies suggested that our novel 4D technology might be able to overcome the challenges of treating alopecia areata topically. The study demonstrated a trend for positive efficacy in both the clinical endpoint of salt change from baseline and salt improvement to 50% or greater, suggesting that, in fact, 4D is able to deliver drug to the site of inflammation.

多種其他局部 JAK 抑制劑先前在治療斑禿方面都失敗了，但臨床前研究表明，我們新穎的 4D 技術可能能夠克服局部治療斑禿的挑戰。研究表明，無論是臨床終點的鹽分從基線變化還是鹽分改善至 50% 或更高，都呈現出積極療效的趨勢，這表明 4D 實際上能夠將藥物輸送到發炎部位。

But unfortunately, the magnitude of improvement was not sufficiently large to justify a continuation of the program. Here, we show the efficacy data alongside that from other independent clinical trials conducted with oral JAK inhibitors in alopecia areata.

但不幸的是，改進的幅度並不足以證明該計畫值得繼續實施。在這裡，我們展示了針對斑禿的其他獨立口服 JAK 抑制劑臨床試驗的療效數據。

Although we were pleased to see the favorable trend that validates our topical formulation approach after extensive consideration of the potential profile relative to alternatives, we decided that this level of efficacy we observed with ARQ-255 would not be a meaningful addition to the treatment options for patients with alopecia areata.

儘管我們很高興看到有利趨勢，在廣泛考慮了相對於替代方案的潛在概況後，驗證了我們的局部製劑方法，但我們認為，我們在 ARQ-255 中觀察到的這種療效水平不會對斑禿患者的治療選擇產生有意義的補充。

We look forward to finding other opportunities outside of ARQ-255 to expand our pipeline and provide meaningful innovation in dermatology. I want to thank the investigators, our advisers and the patients who participated in this program as well as the excellent Arcutis team that conducted a very well-run study. And with that, I'll turn it over to Latha.

我們期待在 ARQ-255 之外尋找其他機會來擴大我們的產品線並在皮膚病學領域提供有意義的創新。我要感謝研究人員、我們的顧問和參與該計劃的患者，以及進行非常順利的研究的優秀的 Arcutis 團隊。說完這些，我就把麥克風交給拉莎 (Latha)。

Thank you, Patrick. I want to start by reiterating the strength of this quarter. Our improved operating leverage allowed the strong top line growth to translate to a reduction in cash burn and reemphasizes that our disciplined approach to capital allocation has us on a path to cash flow breakeven in 2026. I'm on slide 21, showing financial results both year-over-year and quarter-over-quarter for the second quarter of 2025.

謝謝你，派崔克。首先我想重申本季的強勁表現。我們提高的經營槓桿使強勁的營收成長轉化為現金消耗的減少，並再次強調，我們嚴謹的資本配置方法使我們在 2026 年實現現金流收支平衡。我現在看到的是第 21 張投影片，展示的是 2025 年第二季的年比財務表現。

As Todd has stated earlier, we generated net product revenues in the quarter of approximately $81.5 million, which is up 164% from Q2 of 2024 and 28% from Q1 of this year. Cost of sales in the second quarter were $7.5 million compared to $3.5 million in 2024, primarily driven by increased ZORYVE sales volume.

正如托德之前所說，我們本季的淨產品收入約為 8,150 萬美元，比 2024 年第二季成長 164%，比今年第一季成長 28%。第二季的銷售成本為 750 萬美元，而 2024 年為 350 萬美元，主要得益於 ZORYVE 銷售的成長。

Cost of sales decreased 15% sequentially versus the first quarter of 2025 despite increasing sales volume due to an expense recognized in the first quarter for the catch-up amortization of a $10 million sales milestone owed to AstraZeneca for reaching $250 million in cumulative net sales.

儘管銷售量有所增加，但銷售成本與 2025 年第一季相比仍環比下降了 15%，這是由於第一季度確認了一項費用，用於彌補阿斯特捷利康因累計淨銷售額達到 2.5 億美元而欠下的 1000 萬美元銷售里程碑的追補攤銷。

For the second quarter of 2025, our R&D expenses were $19.5 million versus $19.3 million for the corresponding period in 2024. Our R&D spend has remained consistent year-on-year as decreased development costs for roflumilast in adult atopic dermatitis and plaque psoriasis were partially offset by an increase in development costs for pediatric atopic dermatitis.

2025 年第二季度，我們的研發費用為 1,950 萬美元，而 2024 年同期為 1,930 萬美元。我們的研發支出與去年同期保持一致，因為羅氟司特在成人異位性皮膚炎和斑塊狀乾癬方面的開發成本下降被兒童異位性皮膚炎開發成本的增加部分抵消。

SG&A expenses were $69.2 million for the second quarter of '25 versus $58.2 million in the same period last year. up 19% as we invested in our commercial organization to support our current and upcoming launches. Recall, we expanded our sales force in the second half of 2024. SG&A expenses were also up approximately 9% as compared to the first quarter of '25, primarily due to increased sales and marketing costs related to our launch in scalp and body psoriasis.

2025 年第二季的銷售、一般及行政費用為 6,920 萬美元，去年同期為 5,820 萬美元。成長 19%，因為我們投資了商業組織以支持我們目前和即將推出的產品。回想一下，我們在 2024 年下半年擴大了銷售團隊。與 25 年第一季相比，銷售、一般及行政費用也上漲了約 9%，這主要是由於我們推出頭皮和身體牛皮癬產品相關的銷售和行銷成本增加。

Net loss for the quarter decreased by $36.4 million compared to the same period last year and $9.2 million versus the first quarter of 2025. While this rate of improvement in operating results will fluctuate across quarters in line with sales, it clearly demonstrates that we are making substantial progress towards reaching cash flow breakeven in 2026 and that the foundation of our business is strong and getting stronger.

本季淨虧損與去年同期相比減少 3,640 萬美元，與 2025 年第一季相比減少 920 萬美元。雖然經營業績的改善率會隨著銷售額的變化而各個季度波動，但它清楚地表明，我們在實現 2026 年現金流收支平衡的道路上取得了實質性進展，而且我們業務的基礎堅實且日益強大。

Now I'm on slide 22. You can see that we had cash and marketable securities of $191.1 million on our balance sheet as of June 30, 2025, and we were slightly cash flow positive from operating activities this quarter.

現在我講的是第 22 張投影片。您可以看到，截至 2025 年 6 月 30 日，我們的資產負債表上擁有 1.911 億美元的現金和有價證券，本季我們的經營活動現金流略為正值。

This positive net cash flow from operating activities of $325,000 was due in part to our increased gross profit driven by our top line revenue growth, a highly encouraging signal of our progress towards cash flow positivity, but also in part due to timing changes in net working capital that reduced cash used in operations. This is a good example of the type of factors that lead to the quarter-to-quarter fluctuations I mentioned earlier and that we expect to see on occasion in the future.

經營活動產生的 325,000 美元正淨現金流部分歸因於我們的營業收入增長帶動毛利潤增加，這是我們在實現現金流正向增長方面取得進展的一個非常令人鼓舞的信號，但也部分歸因於淨營運資本的時間變化，從而減少了經營活動所用的現金。這是導致我之前提到的季度波動的因素類型的一個很好的例子，我們預計未來偶爾會看到這種波動。

We expect our quarterly cash burn to continue trending down as our revenues grow and we approach stable positive cash flow from operations sometime in 2026. We have total debt of $108 million and have the option to withdraw another $100 million in whole or in part at our discretion through the middle of 2026, providing us with significantly enhanced flexibility. The success of ZORYVE portfolio and the economies of scale we are generating will permit us to invest in the business for continued growth and long-term durability.

我們預計，隨著收入的成長，我們的季度現金消耗將繼續呈下降趨勢，並且我們將在 2026 年某個時候實現穩定的正營運現金流。我們的總債務為 1.08 億美元，並且可以選擇在 2026 年中期自行決定全部或部分提取另外 1 億美元，這為我們提供了大大增強的靈活性。ZORYVE 產品組合的成功和我們正在創造的規模經濟將使我們能夠投資於業務，以實現持續成長和長期持久性。

With that, I'm going to hand it back to Frank for some closing remarks.

說完這些，我將把發言權交還給法蘭克，請他做最後的總結發言。

Thanks, Latha. As you've heard throughout today's call, we built a strong and sustainable foundation for our business and our prospects for continued near, medium and long-term growth at Arcutis are strong. As we continue to execute our multifaceted plans to sustain this growth, we look forward to sharing updates on our progress.

謝謝，拉莎。正如您在今天的電話會議中所聽到的，我們為我們的業務建立了強大而可持續的基礎，並且 Arcutis 持續實現近期、中期和長期增長的前景十分強勁。隨著我們繼續執行多方面的計劃以維持這一增長，我們期待分享我們的進展更新。

And to that end, we will be holding an R&D Day in the fourth quarter of this year to go into greater detail on several key aspects of our clinical development plans and corporate strategy.

為此，我們將在今年第四季舉辦研發日活動，更詳細地討論我們的臨床開發計畫和公司策略的幾個關鍵面向。

And with that, we'll open up the call to Q&A.

接下來，我們將開始問答環節。

(Operator Instructions)

（操作員指示）

Seamus Fernandez, Guggenheim Securities.

古根漢證券公司的謝默斯·費爾南德斯。

Congrats on the great quarter and reaching at least for this quarter, cash flow positivity. A couple of questions here. maybe just to start off, as we think about the sort of progression of revenue from second quarter to third quarter, it sounds like we should think about this as a little bit of a perhaps even a slightly down quarter? Or should we think about it more as a sort of flat progression or moderating growth as we think about third quarter?

恭喜本季度取得了出色的成績，至少本季度實現了現金流正增長。這裡有幾個問題。也許只是開始，當我們考慮從第二季到第三季的營收成長時，聽起來我們應該認為這是一個甚至略有下降的季度？或者，當我們考慮第三季時，我們應該將其更多地視為一種平穩進展或適度增長？

And then, Frank, I think it's very obvious the opportunity to continue to really pursue the switch from topical steroids more broadly, especially considering the range of areas where topical steroids are utilized. But I wanted to just get a better sense of how far reaching you feel the opportunity is to move beyond the 4 initial indications here.

然後，弗蘭克，我認為，繼續更廣泛地尋求從外用類固醇轉換的機會非常明顯，特別是考慮到外用類固醇的使用範圍。但我只是想更好地了解，您認為超越這裡的 4 個初始跡象的機會有多大。

Obviously, there's a number of indications that were listed on the slide on the R&D side. But you also mentioned potential business development pursuits moving forward beyond the existing pipeline. What do you feel would be kind of a good right fit for the company as you look beyond this? Is it to be able to scale the business with on-market assets? Or is it more to really release your R&D organization given the sort of clinical excellence that's been demonstrated so far?

顯然，研發方面的幻燈片上列出了許多跡象。但您也提到了超越現有通路的潛在業務發展追求。從這個角度來看，您認為什麼才是最適合公司的？是否能夠利用市場資產擴大業務規模？或者，考慮到迄今為止所展現的臨床卓越性，這是否更能真正釋放您的研發組織？

Yes. So Seamus, maybe I'll answer your second question first, and then I'll ask Todd to address the question around revenue. I think that -- from a clinical standpoint, it's pretty clear that ZORYVE has very broad applicability across a whole range of diseases, I think potentially even some non-inflammatory conditions. But they're not probably all worth us pursuing an indication for. I think we will look to generate data to inform the dermatology community where it's appropriate.

是的。所以 Seamus，也許我會先回答你的第二個問題，然後我會請 Todd 回答有關收入的問題。我認為——從臨床角度來看，很明顯 ZORYVE 在一系列疾病中具有非常廣泛的適用性，我認為甚至可能適用於一些非發炎疾病。但它們可能不都值得我們去追求。我認為我們將尋求產生數據，以便在適當的情況下告知皮膚病學界。

And then we'll look at those opportunities and determine is the market big enough? Is the magnitude of clinical improvement versus existing therapies big enough that it justifies pursuing an indication. And so we'll be very rigorous and selective in choosing those diseases where we think it's worth spending the money to do a full registrational program.

然後我們會研究這些機會並確定市場是否足夠大？與現有療法相比，臨床改善的幅度是否足夠大，足以證明追求某一適應症是合理的。因此，我們將非常嚴格和有選擇性地選擇那些我們認為值得花錢進行全面註冊計劃的疾病。

But I'm pretty confident that there are going to be other diseases that it makes sense for us to pursue an indication. particularly given how stringent insurance companies have become about the off-label reimbursement of drugs. It's very different than it was 10 years ago even. So I think there's a lot of upside opportunity for us. There are a lot of steroid prescriptions for diseases other than our currently approved indications. And so we'll just need to be very rigorous and methodical in choosing which ones we just generate data on which ones we pursue an indication for.

但我非常有信心，對於其他疾病來說，尋求其適應症也是有意義的。特別是考慮到保險公司對藥品非說明書報銷的嚴格程度。這與 10 年前相比有很大不同。所以我認為我們有很多上行機會。除了我們目前批准的適應症外，還有很多針對其他疾病的類固醇處方。因此，我們只需要非常嚴格和有條理地選擇哪些是我們要產生的數據，哪些是我們要追求的指示。

Turning to the business development side, I would say that our primary focus is really on development stage assets Patrick and his team and Bethany and her team on the tech up side have, I think, proven that they are really outstanding, I would even say, best-in-class in dermatology and their ability to complete clinical development, regulatory approval.

談到業務發展方面，我想說我們的主要關注點實際上是開發階段的資產，帕特里克和他的團隊以及貝瑟尼和她的技術團隊已經證明他們確實非常出色，我什至會說，他們是皮膚病學領域中最好的，他們有能力完成臨床開發和監管審批。

And then Todd and his team have shown how they can effectively operate commercially as well. So we think that's probably the best area for us to focus on the -- in terms of creating value for shareholders. We are not a spec pharma company. I'm not interested in going around and just buying revenue and adding that to the pipeline. I don't think that's a good way for us to create shareholder value. But leveraging the development expertise of this company, I think, is a great opportunity.

然後托德和他的團隊展示了他們如何有效地進行商業運作。因此，我們認為，就為股東創造價值而言，這可能是我們最應該關注的領域。我們不是一家特種製藥公司。我對到處購買收入並將其添加到管道中不感興趣。我認為這不是我們創造股東價值的好方法。但我認為，利用這家公司的開發專業知識是一個很好的機會。

And we continue to focus primarily on drugs where there is biological validation of the target. So we're not taking on too much biologic risk. where there's a large unmet need and where we find an asset that is really differentiated from other assets, we're not going to be pursuing a bunch of me-too assets. So hopefully, that addresses your question. And well, again, we'll talk about this a lot more at the R&D Day. And then I'll turn it over to Todd to talk about Q3 and the rest of the year.

我們將繼續專注於那些已通過生物學驗證的藥物。因此，我們不會承擔太多生物的風險。當存在大量未滿足的需求並且我們發現一種與其他資產真正有區別的資產時，我們不會追求一堆模仿資產。希望這能解答您的問題。好吧，我們會在研發日上更詳細地討論這個問題。然後我將把話題交給托德來談論第三季和今年剩餘時間的情況。

Yes. Great. Thank you, Frank. And Seamus, we still anticipate sequential growth in the third quarter as we expect continued growth across all indications. The rate of growth in the third quarter will be slightly moderated due to the seasonality that we spoke about. But nonetheless, we remain very optimistic about the growth. I'll just frame it that we continue to want to see sustained momentum within this franchise and will in Q3 and beyond.

是的。偉大的。謝謝你，弗蘭克。西莫斯，我們仍然預計第三季將實現環比成長，因為我們預計所有指標都將繼續成長。由於我們所說的季節性因素，第三季的成長率將略有放緩。但儘管如此，我們仍然對成長非常樂觀。我只是想說，我們希望看到這個系列繼續保持持續的發展勢頭，並將在第三季度及以後繼續保持。

Tyler Van Buren, TD Cowen.

泰勒範布倫 (Tyler Van Buren)，TD Cowen。

This is Yena on for Tyler. I had a question about the Kowa partnership. And you guys also mentioned that you set up a national dedicated pharmacy. I was wondering what the early utilization of that looked like. And again, could you elaborate on the contribution of the Kowa partnership to date?

這是 Yena 代替 Tyler 上場。我有一個關於 Kowa 合作關係的問題。你們也提到設立了全國性專營藥局。我想知道它的早期利用情況是什麼樣的。您能否再次詳細說明 Kowa 合作夥伴關係迄今為止所做出的貢獻？

Yes. This is Todd. Yes, thank you for the question. And as discussed before, we anticipated a slower adoption of ZORYVE in the primary care market versus the dermatology market due to the longer selling cycle that's required, also with primary care physicians not being as familiar with nonsteroidal topicals. And we are seeing that slower adoption of ZORYVE within the primary care market.

是的。這是托德。是的，謝謝你的提問。如同先前所討論的，我們預期 ZORYVE 在初級保健市場中的採用速度會比皮膚病學市場慢，因為所需的銷售週期更長，而且初級保健醫生對非類固醇用藥不太熟悉。我們發現 ZORYVE 在初級保健市場的採用速度正在放緩。

However, Kowa is taking the right actions to make certain that we have the right frequency on the right targets with the right messaging and also making certain that they continue to educate primary care physicians and other opportunities like peer-to-peer programs, speaker programs and such.

然而，Kowa 正在採取正確的行動，以確保我們以正確的頻率向正確的目標傳達正確的訊息，並確保他們繼續教育初級保健醫生和其他機會，如點對點計劃、演講者計劃等。

Relative to the national pharmacy, we're seeing very positive signals with the early launch of that national pharmacy. And as mentioned, it's critical that we provide a dedicated pharmacy that will appropriately enable and support the primary care physicians relative to the fulfillment process with ZORYVE. And once again, we're seeing positive signals with that and are encouraged by Kowa is continuing to adapt and execute on the right targets with the right frequency and what we expect from this national pharmacy.

相對於全國性藥局，我們看到了全國性藥局早期推出的非常正面的訊號。如同前面所提到的，至關重要的是，我們要提供一個專門的藥房，為初級保健醫生提供與 ZORYVE 履行流程相關的適當支援。我們再次看到了積極的信號，並受到 Kowa 的鼓舞，該公司將繼續以正確的頻率調整和執行正確的目標，實現我們對這家全國性藥局的期望。

Uy Ear, Mizuho.

尤伊·厄爾，瑞穗。

Congrats on the quarter. So maybe just first question is, could you maybe just help us understand the gross to net dynamics in the quarter was better than what we expected, particularly for each of the individual products, if possible or just the foam?

恭喜本季取得佳績。所以也許第一個問題是，您能否幫助我們了解本季的毛利與淨利動態是否比我們預期的要好，特別是對於每種單獨的產品（如果可能的話）還是僅僅是泡沫？

Do you have additional questions? Do you want to finish them off?

您還有其他問題嗎？你想消滅他們嗎？

No, no, that's fine. I'll follow up.

不不不，沒關係。我會跟進。

Okay. So in regards to gross to net, as Todd commented, we -- gross to net has been stable for the quarter and in the 50s. And beyond that, we haven't quite ever commented on the products. So I'm going to leave it at the 50s.

好的。因此，關於毛利與淨利的比率，正如托德所評論的那樣，本季度毛利與淨利的比率一直保持穩定，在 50 左右。除此之外，我們從未對這些產品發表過評論。所以我要把它保持在 50 年代。

Gross to net is not changing very much anymore, and I wouldn't expect that it would.

總額與淨額的比率不再有太大變化，而且我也不認為會有太大變化。

Okay. And I guess in the press release, you guys commented on 3 patents that was allowed, I guess, in the quarter. Could you sort of elaborate on that?

好的。我想，在新聞稿中，你們評論了本季批准的 3 項專利。能詳細說明一下嗎？

We had -- yes, we had three additional patents that were issued in the quarter from the US Patent Office. None of those extended the LOE for the product. But I think they are further expand the strength of our IP portfolio. We now have 24 issued US patents and many of those listed in the Orange Book. And I just think that it speaks to the further -- the continued strength of our intellectual property portfolio around ZORYVE.

是的，我們在本季獲得了美國專利局頒發的另外三項專利。這些都沒有延長產品的 LOE。但我認為他們正在進一步擴大我們的知識產權組合的實力。我們目前擁有 24 項已頒發的美國專利，其中許多專利已列入橙皮書。我認為這進一步說明了我們圍繞 ZORYVE 的智慧財產權組合的持續強勁。

Okay. And sorry, last question. You mentioned two studies, two Phase II studies that are ongoing. And I guess one of them is the atopic study in pediatric three months to two years old. What's the other one?

好的。抱歉，這是最後一個問題。您提到了兩項研究，兩項正在進行的第二階段研究。我想其中之一就是針對 3 個月至 2 歲兒童的過敏性研究。另一個是什麼？

So we talked about initiation of a 3- to 24-month study in atopic dermatitis with ZORYVE, that's the 0.05%. That is a sponsored clinical trial that's part of a post-marketing commitment that we have in order to continue to step the age down that we are conducting as a sponsored registrational clinical trial. The other two Phase II studies that we're talking about are collaborative research trials, which are being done to get an early understanding of the potential efficacy in two of these indications, which are not currently approved indications, but where we have seen some evidence of efficacy coming from case reports.

因此，我們討論了使用 ZORYVE（即 0.05%）進行為期 3 至 24 個月的異位性皮膚炎研究。這是一項贊助臨床試驗，也是我們上市後承諾的一部分，我們旨在繼續降低我們作為贊助註冊臨床試驗所進行的年齡。我們正在討論的另外兩項 II 期研究是合作研究試驗，旨在儘早了解其中兩種適應症的潛在療效，這兩種適應症目前尚未獲得批准，但我們已從病例報告中看到了一些療效證據。

And so that will give us a kind of quick and early understanding of what the efficacy might and safety might be in that disease state to help us to then make decisions on whether or not to pursue a registrational program for one of these indications.

這樣，我們就能快速、儘早地了解該藥物在相應疾病狀態下的療效和安全性，從而幫助我們決定是否針對其中一種適應症開展註冊計劃。

And just to clarify, those Phase II studies are in HS and vitiligo, I believe both of them are posted on clintrials.gov now.

需要澄清的是，這些 II 期研究是針對 HS 和白斑的，我相信它們現在都已發佈在 clintrials.gov 上。

Andrew Tsai, Jefferies.

安德魯·蔡（Andrew Tsai），傑富瑞（Jefferies）。

Congrats on the execution. Maybe a bigger question. Can you give us your latest and greatest thinking on how you're thinking about the peak sales opportunity across your 3 current indications and how that's changed compared to your original thinking?

恭喜執行。也許是一個更大的問題。您能否為我們提供您最新和最棒的想法，即您如何看待當前 3 個適應症的峰值銷售機會，以及與您最初的想法相比有何變化？

So Andrew, we have not given peak sales guidance for quite some time. I think it was 2022 last time. At that point, we had said that we thought that each one of the indications, i.e., psoriasis, AD and seb derm could be in the range of $700 million to $1.2 billion per indication. I think we have not dramatically changed that view of the opportunity.

所以安德魯，我們已經有一段時間沒有給出峰值銷售指導了。我認為上次是 2022 年。當時，我們曾表示，我們認為每一種適應症，即牛皮癬、AD 和脂漏性皮膚炎，其治療費用可能在 7 億美元至 12 億美元之間。我認為我們並沒有徹底改變對這一機會的看法。

If you just sit down and do some quick back of the envelope calculations, we're sitting at something like 2.5% market share in the total topical market. If that grows to 10%, you're well north of $1 billion. And I think that 10% of the topical market is very achievable and probably is a low bar given the clinical profile that we see and particularly if we expand beyond the three initial indications, as Patrick just mentioned.

如果您只是坐下來做一些快速的粗略計算，我們在整個主題市場中的市佔率約為 2.5%。如果這數字成長至 10%，那麼你的營收將遠遠超過 10 億美元。我認為 10% 的局部用藥市場是非常有可能實現的，而且考慮到我們看到的臨床情況，這可能是一個較低的門檻，特別是如果我們擴展到最初的三個適應症之外，正如帕特里克剛才提到的那樣。

What I will say is that we continue to evaluate this. And I think you can expect some further guidance from us in the future about what we think the peak sales potential is. But clearly, we are really just scratching the surface in the total commercial opportunity for ZORYVE.

我想說的是，我們會繼續評估這一點。我認為，未來您可以期待我們提供進一步的指導，了解我們認為的高峰銷售潛力。但顯然，我們只是觸及了 ZORYVE 整體商業機會的表面。

Agreed. And then a follow-up to the last question on vitiligo and HS. Is it possible that we get initial data from the IST studies in 2026? Or is it sometime later? Just wanted to gauge your news flow.

同意。然後是關於白斑症和 HS 的最後一個問題的後續問題。我們有可能在 2026 年獲得 IST 研究的初步資料嗎？還是要過一段時間？只是想了解你的新聞流。

Yes. I mean, right now, we're not putting out any expected time line for those trials. As we get engaged into our collaborative research that we're pursuing for these Phase II trials, we'll have a more clear understanding of what that might be. So we would expect to provide some guidance as we get further into them. But at the current time, we're not able to give a milestone or expected time line.

是的。我的意思是，目前我們還沒有公佈這些試驗的任何預期時間表。隨著我們參與這些第二階段試驗的合作研究中，我們將對這可能是什麼有更清晰的了解。因此，我們希望在進一步研究這些問題時提供一些指導。但目前我們還無法給出一個里程碑或預期的時間表。

Judah Frommer, Morgan Stanley.

猶大‧弗洛默，摩根士丹利。

On the quarter. Just a couple for us. I guess, first, we're hoping you can maybe elaborate a little bit on the pediatric opportunity in atopic derm, kind of what penetration ramp could look like there relative to in adults given kind of potentially arguably greater unmet need or safety concerns there for those patients?

按季度計算。對我們來說只是一對。我想，首先，我們希望您能詳細說明一下兒科異位性皮膚病的機會，考慮到這些患者可能存在更大的未滿足需求或安全問題，相對於成人，兒科的滲透坡度會是什麼樣的？

And then separately, I think this week, we saw a second joint status update on the Padagis litigation. Just curious if there was anything you could add there? Is the case just stayed and we're waiting for an update? Or was there more to that?

然後另外，我想本週，我們看到了有關 Padagis 訴訟的第二次聯合狀態更新。只是好奇您是否可以添加一些內容？案件就這樣擱置了，我們等待最新消息嗎？或是還有更多事情發生？

Yes. Patrick, do you want to maybe take the first of those questions?

是的。派崔克，你想回答第一個問題嗎？

Yes. We're really excited about the opportunity in 2- to 5-year-olds that's upcoming with the 0.05% when that's the approval that has a PDUFA in October. Out of the 9.6 million patients -- pediatric patients with AD, about 1.8 million of them are in this 2- to 5-year-old age range that are being topically treated. And so we were just at the Society for Pediatric Dermatology meeting in Seattle and really got a very good understanding of just how important this age group is to them. I think because many of these are kind of difficult to manage patients.

是的。我們對即將在 10 月獲得 PDUFA 批准的 0.05% 劑量的疫苗在 2 至 5 歲兒童中應用的機會感到非常興奮。在 960 萬名患有 AD 的兒科患者中，約有 180 萬名年齡在 2 至 5 歲之間，正在接受局部治療。因此，我們剛剛參加了在西雅圖舉行的兒童皮膚病學會會議，並真正了解這個年齡層對他們的重要性。我認為這是因為其中很多病人都很難管理。

As I mentioned, this is a disease that comes on early in life, and there's a lot of avoidance of topical steroids from parents. So what we're looking to be able to do is to present an option into these deeper age ranges. And 2- to 5-year-olds is the first step for us. And as we mentioned, we're getting started with the 3- to 24-month old trial as well with the same concentration. And I think it's just a very good fit between the need and the expectation of parents to be able to manage their kids without topical steroids and the profile that we've been able to show so far. So we're really excited about the upcoming approval.

正如我所提到的，這是一種在生命早期就發病的疾病，父母通常會避免使用外用類固醇。因此，我們希望能夠為這些更深層的年齡範圍提供一種選擇。2至5歲的兒童是我們踏出的第一步。正如我們所提到的，我們也將以同樣的重點開始 3 至 24 個月的試驗。我認為，這非常符合父母的需求和期望，即能夠在不使用外用類固醇的情況下照顧他們的孩子，而且我們迄今為止已經展示了這種效果。因此，我們對即將獲得的批准感到非常興奮。

Yes. And Patrick and I were both just at the Society of Pediatric Derm two weeks ago. Do you want to maybe just give some color about the tenor of the conversations at SPD?

是的。兩週前，派崔克和我剛參加了兒童皮膚病學會。您是否想簡單介紹一下 SPD 對話的基調？

Yes. I mean there are conversations were about a very large patient flow in their offices for this age range because of the challenges of topical corticosteroid use. And it's common for a patient to be seen in a pediatrician's office, they might get one topical corticosteroid as their kind of start off.

是的。我的意思是，由於局部使用皮質類固醇的挑戰，他們的辦公室裡這個年齡層的患者流量非常大。對於在兒科醫生辦公室就診的患者來說，他們通常會接受一種外用皮質類固醇治療作為開始治療。

And then if that's not able to completely manage the disease, then they're looking to be referred oftentimes either to a pediatric dermatologist if one is available. But dermatologists, it's very common for them, even if they are seen as adult dermatologists to be seeing patients down into the age of two and sometimes even younger than that.

如果這還不能完全控制病情，那麼他們通常需要轉診給兒科皮膚科醫生（如果有的話）。但對於皮膚科醫生來說，即使他們被視為成人皮膚科醫生，他們也經常會診到兩歲甚至更小的患者。

So not all of these patients are managed by pediatric derms. But pediatric derms definitely represent kind of the core for education within this age group, and they influence a lot pediatrician prescribing and pediatrician openness to being able to use a new therapy. So we think our contact points within both the pediatric dermatology community are really important. And that's what we were seeing when we were at the Society for Pediatric Dermatology, but also the adult dermatology health care providers are a really important point for managing these patients also.

因此，並非所有這些患者都接受兒科皮膚科醫師的治療。但兒科皮膚科絕對代表了這個年齡教育的核心，它們對兒科醫生的處方和兒科醫生對使用新療法的開放程度有很大影響。因此我們認為我們在兒科皮膚病學界的聯繫點非常重要。這就是我們在兒童皮膚病學會看到的情況，但成人皮膚病保健提供者對於管理這些患者也非常重要。

And then just with regard to the Padagis case, recall that there is a requirement in the litigation stay that the two parties jointly provide periodic updates to the court. The first one of those updates has just recently been provided. those updates are confidential. In fact, even I don't see them, but it was provided for in the stay. And I think the one relevant data point that all of us should be aware of was is that everyone agreed that the stay should and will remain in place.

然後就帕達吉斯案而言，回想一下，訴訟中止時有一項要求，即雙方共同向法院定期提供最新情況。其中第一個更新最近剛剛提供。這些更新是保密的。事實上，即使我也沒有看到它們，但這是住宿期間提供的。我認為我們所有人都應該知道的一個相關數據點是，每個人都同意暫停措施應該並且將繼續實施。

Serge Belanger, Needham.

塞爾日·貝朗格，尼德漢姆。

Congrats on a great quarter. First question, regarding the 2Q performance, I think you mentioned that sales were up 28% quarter-over-quarter. I believe scripts were up 13%. So maybe just reconcile the difference. Was it just a bump up in gross to nets from Q1? And I guess the follow-up to that is, I think you mentioned you expect gross to nets to be stable for the rest of the year.

恭喜本季取得優異成績。第一個問題，關於第二季的業績，我記得您提到銷售額環比成長了 28%。我認為劇本數量上漲了 13%。所以也許只是調和差異。這僅僅是第一季總收入與淨收入之間的一個成長嗎？我想接下來的問題是，我想您提到過，您預計今年剩餘時間內的毛收入與淨收入之比將保持穩定。

So should we expect script growth to be the main driver for sales over the remainder of 2025? Second question, I think Todd talked a little bit about the issues regarding Medicare Part D. Can you remind us what part of the TAM Medicare Part D represents for ZORYVE? And when do you think you'll be in a position to kind of capture that opportunity and get coverage from those plants?

那麼，我們是否應該預期劇本成長將成為 2025 年剩餘時間內銷售的主要驅動力？第二個問題，我認為 Todd 談到了一些關於 Medicare Part D 的問題。您能否提醒我們，對於 ZORYVE 來說，Medicare Part D 代表 TAM 的哪一部分？您認為什麼時候才能抓住這個機會並獲得這些工廠的覆蓋範圍？

Todd, do you want to maybe address the bridge on sales?

托德，你想談談銷售上的橋樑問題嗎？

Yes, address the bridge on sales. The main driver of the product revenue growth over demand growth was a recovery in distribution inventory levels back to normal following a drawdown in the first quarter. What I want to be clear about is that we did not see abnormal inventory stocking levels in the second quarter. This was simply recovery back to normal levels as a result of the drawdown in the first quarter.

是的，解決銷售方面的橋樑問題。產品收入成長超過需求成長的主要驅動力是分銷庫存水準在第一季下降之後恢復正常。我想明確的是，我們在第二季度沒有看到異常的庫存水準。這只是第一季下降後恢復到正常水平。

In reference to gross to net, as mentioned and as Latha reinforced, we expect gross to net to be stable for the remainder of the year. So yes, that will -- the primary growth driver will be volume and demand. We're very encouraged in what we see across the portfolio. We recently launched ZORYVE foam 0.3% for scalp and body psoriasis that will continue to be a growth driver. And then as Patrick mentioned, with the pending approval in October for ZORYVE 0.05% two to five, we continue to be very optimistic and encouraged by future growth in our demand.

關於總額與淨額的比率，正如所提到的以及 Latha 所強調的，我們預計今年剩餘時間內總額與淨額的比率將保持穩定。是的，主要的成長動力將是產量和需求。我們對整個投資組合的表現感到非常鼓舞。我們最近推出了用於治療頭皮和身體牛皮癬的 0.3% ZORYVE 泡沫，這將繼續成為成長動力。正如帕特里克所提到的，隨著 10 月份 ZORYVE 0.05% 2 至 5 的批准，我們繼續對未來的需求成長感到非常樂觀和鼓舞。

Yes. And then just with regard to Serge, your question around Part D, across the three diseases, keep in mind, let's say, roughly about half of those patients across our three indications are government pay, either Medicare or Medicaid. And the relative split between Medicare and Medicaid really varies by disease. Atopic dermatitis is much more heavily Medicaid because of the age of the patients. Seb derm is much more heavily Medicare because of the age of the patients.

是的。然後就 Serge 而言，您關於 D 部分的問題，涉及這三種疾病，請記住，我們三種適應症中大約有一半的患者是由政府支付的，無論是醫療保險還是醫療補助。醫療保險和醫療補助之間的相對差距確實因疾病而異。由於患者的年齡，異位性皮膚炎的醫療補助費用較高。由於患者的年齡，脂漏性皮膚炎的醫療保險負擔要重得多。

And psoriasis is somewhere in between, although less psoriasis patients are government than with Seb derm or AD. So I think in totality, again, it's about half are government. We're rapidly penetrating into Medicaid, slightly less than half of that half is Medicare. Does that address your question around the Medicare piece?

牛皮癬介於兩者之間，儘管牛皮癬患者中，政府介入的人數比脂漏性皮膚炎或阿茲海默症患者少。所以我認為總體而言，大約有一半的政府乾預。我們正在快速滲透到醫療補助計劃，其中略少於一半的是醫療保險。這是否解答了您關於醫療保險的問題？

Yes. I guess the other part of that question was, when do you think you'll be in a position to start capturing that coverage?

是的。我想這個問題的另一部分是，您認為什麼時候才能開始獲得這種報道？

Yes. That is hard to say because, unfortunately, it's completely outside of our control, right? As Todd mentioned, the dynamic that we're seeing is -- and you all probably have seen this if you cover the insurance companies, with the changes in the IRA that were adopted January 1 of this year, the insurance companies are losing a substantial amount of money on their Part D book of business and a number of them have had to issue earnings warnings even as a result of that. And that disruption then is leading them to be, I think, very conservative and to be looking at their businesses.

是的。這很難說，因為不幸的是，這完全超出了我們的控制範圍，對吧？正如托德所提到的，我們看到的動態是——如果你關注保險公司，你可能已經看到了這一點，隨著今年 1 月 1 日實施的 IRA 變化，保險公司在其 D 部分業務上損失了大量資金，其中一些公司甚至因此不得不發布盈利預警。我認為，這種混亂導致他們變得非常保守，並開始審視自己的業務。

To the best of our knowledge, I don't think any new drugs have been added this year to the Medicare Part D formularies across all indications. So that tells you just sort of how perturbed they are. we don't know when things are going to settle out and they're going to start moving forward again. We continue to have, I think, constructive dialogues with the Medicare Part D plans.

據我們所知，我認為今年醫療保險 D 部分處方集中並未添加任何適用於所有適應症的新藥。所以這告訴你他們有多不安。我們不知道什麼時候事情會平息下來，他們才會再次開始向前發展。我認為，我們將繼續與聯邦醫療保險 D 部分計劃進行建設性對話。

But when your boat is sinking, the last thing you're thinking about is picking up new passengers. And I think that's a little bit how they feel right now. I expect it will stabilize. We think Medicare is still an important opportunity for us and will contribute to our growth in the future. I just -- it's very difficult at this point for us to call the ball on what the timing would be for that.

但當你的船正在下沉時，你最不想考慮的就是搭載新的乘客。我想他們現在的感受也差不多是這樣。我預計它會穩定下來。我們認為醫療保險對我們來說仍然是一個重要的機會，並將為我們未來的成長做出貢獻。我只是──現在我們很難判斷什麼時候會發生這種事。

Okay. Maybe one last one. Obviously, your sales force has executed well, growing sales here in the second quarter. And it sounds like Kowa had -- still has little contribution so far. So with the additional approvals coming up later this year, is there a case to be made to continue expanding your own sales force to continue executing well and growing the piece within the derm offices?

好的。也許是最後一個。顯然，您的銷售團隊表現出色，第二季的銷售額有所成長。聽起來，Kowa 到目前為止的貢獻仍然很小。那麼，隨著今年稍後將獲得更多批准，是否有理由繼續擴大自己的銷售隊伍，以繼續良好地執行並發展皮膚科辦公室的業務？

So I don't think we see or see at this point any need to expand in dermatology. We have a very well-sized dermatology sales force, and we have good coverage, good frequency on our dermatology targets. What we will have to continue to evaluate is opportunities outside of dermatology and think about how we address those opportunities.

因此我認為我們目前還看不到皮膚病學方面有任何擴張的必要。我們擁有一支規模龐大的皮膚病學銷售隊伍，我們的皮膚病學目標覆蓋率高，銷售頻率高。我們必須繼續評估皮膚病學以外的機會，並思考如何抓住這些機會。

We felt that the Know partnership was a smart way, an economical way for us to access the primary care and pediatric opportunities. But at this point in the game, we don't have any plans for any further sales force expansions on the Arcutis sales force.

我們認為與 Know 的合作是一種明智且經濟的方式，讓我們獲得初級保健和兒科機會。但就目前情況而言，我們還沒有進一步擴大 Arcutis 銷售團隊的計畫。

Douglas Tsao, H.C. Wainwright.

Douglas Tsao、H.C. Wainwright。

Congrats on the progress. I'm just curious, when we look at -- I think it's slide 11, and you obviously -- as writers or as doctors write more for more indications, you sort of get a real economy of scale or sort of logarithmic effect in terms of the scripts that they're writing.

恭喜你取得進展。我只是很好奇，當我們看——我想是第 11 張幻燈片，你顯然——作為作家或醫生，為了更多的適應症寫更多的東西，你會在他們所寫的腳本方面獲得真正的規模經濟或對數效應。

How long does it typically take for docs to write for multiple scripts? Are they sort of coming at it sort of incrementally? And are there things that you can do or have started to do to sort of increase the indications that an individual doc is writing for?

編寫多個腳本的文檔通常需要多長時間？他們是在逐步實現這個目標嗎？您是否可以做一些事情或已經開始做一些事情來增加個人文件所寫的指示？

Yes. Thank you for the question. Arcutis is in a very good position with ZORYVE. And what I mean by that is that with the recent launches that we've had with indications, the dermatology prescribers have already had experience with ZORYVE, whether it be with the cream 0.3% for psoriasis or the own formulation for seborrheic dermatitis. This drives rapid uptake relative to the other indications or formulations that we've launched.

是的。謝謝你的提問。Arcutis 與 ZORYVE 合作處於非常有利的地位。我的意思是，隨著我們最近推出適應症的產品，皮膚科處方人員已經對 ZORYVE 有了經驗，無論是用於治療牛皮癬的 0.3% 乳膏還是用於治療脂漏性皮膚炎的自身配方。與我們推出的其他適應症或配方相比，這推動了其快速發展。

And we do see that within the data that a good portion of our prescribing base has adopted the full formulary. This creates efficiencies with their prescribing, both with the patient, but also on the fulfillment side, given that's the same co-pay card, same pharmacy, same process.

我們確實從數據中看到，我們處方基礎的很大一部分已經採用了完整的處方集。由於使用的是相同的共同支付卡、相同的藥房和相同的流程，因此這不僅提高了患者的處方效率，也提高了履行方面的效率。

So that it's a differentiation - excuse me, ZORYVE as an asset, meaning that across the different formulations and products, you can write the product relative to any duration time anywhere on the body. We have a proven efficacy, proven safety. So this type of differentiation really compels the providers to continue to adopt the new formulations and indications we put into the market.

所以這是一種差異化 - 對不起，ZORYVE 是一種資產，意味著在不同的配方和產品中，您可以根據身體任何部位的任何持續時間來編寫產品。我們已經證明其功效和安全性。因此，這種差異化確實迫使供應商繼續採用我們進入市場的新配方和新適應症。

And I'm just curious, if I can, a follow-up just to the extent that some doctors might only still be writing for one indication, is it your sense that perhaps they don't have awareness of the breadth of the label? Or is it perhaps unique to their practice where they just might see sort of have a concentration into one of the indications?

我很好奇，如果可以的話，我進行後續跟進，發現有些醫生可能仍然只針對一種適應症開藥，您是否認為他們可能沒有意識到標籤的廣度？或者這是否是他們實踐中獨有的，他們可能只是集中精力於其中一種症狀？

Yes. Within our dermatology target universe, the dermatologists that have only adopted one indication is truly the exception. And usually, that's something that's unique to their practice or to their patient population. We continue to engage with dermatologists, educate them on the ZORYVE differentiation and opportunity and expect that over time, they will have adoption of the portfolio.

是的。在我們的皮膚病學目標領域中，僅採用一種適應症的皮膚科醫生確實是例外。通常，這是他們的實踐或患者群體所獨有的。我們繼續與皮膚科醫生合作，向他們介紹 ZORYVE 的差異化和機遇，並期望隨著時間的推移，他們會採用該產品組合。

Richard Law, Goldman Sachs.

高盛的理查德·勞 (Richard Law)。

Congrats on the progress. A couple of questions from us. So following up on the Medicare discussion, what drug classification would ZORYVE fall into in your Medicare coverage discussions or negotiations? Is it classified along with topical steroid? Or can you get your own separate classes of topical PDE for? And also, what is the progress in Medicaid over the last quarter?

恭喜你取得進展。我們有幾個問題。那麼，在醫療保險討論之後，ZORYVE 在您的醫療保險覆蓋範圍討論或談判中屬於哪種藥物分類？它與外用類固醇屬於同一類嗎？或者您可以獲得自己單獨的主題 PDE 類別嗎？另外，上個季度醫療補助計劃取得了哪些進展？

Relative to with regard to Medicare relative to the class, the market basket, if you will, we would be within the dermatology topical basket as how Medicare would position ZORYVE. In reference to Medicaid, we've had exceptional success in expanding our Medicaid access.

相對於醫療保險的類別、市場籃子，如果你願意的話，我們將在皮膚科外用籃子內，就像醫療保險如何定位 ZORYVE 一樣。關於醫療補助，我們在擴大醫療補助覆蓋範圍方面取得了非凡的成功。

If you think about it, and as mentioned, more than half of Medicaid patients now have access to ZORYVE. And most often, that's only a single step through a steroid. And we continue to be steadfast in expanding that access, ensuring that Medicaid recipients continue to have an expanded access to ZORYVE.

如果你仔細想想，如前面提到的，現在超過一半的醫療補助患者可以使用 ZORYVE。而大多數情況下，這只是透過類固醇的一個步驟。我們將繼續堅定不移地擴大這種訪問管道，確保醫療補助的接受者能夠繼續擴大對 ZORYVE 的訪問。

Okay. Just kind of follow-up on that. So basically, is there a way to get a separate classes like a topical PDE4 or just the broad basket that you mentioned?

好的。只是對此進行跟進。所以基本上，有沒有辦法獲得單獨的類別，例如主題 PDE4 或僅僅是您提到的廣泛的籃子？

Yes. It would be difficult to get just a PD4 class. They want to keep the topical products in the same market basket. And actually, that's advantageous for us given ZORYVE's differentiation, not only from an asset, but how we strategically price the product within the market. So you take that strategic pricing within the market and you also take into consideration the average utilization of tubes per patient per year is two to three. We're a great value proposition to the Part D plans as well as the beneficiaries.

是的。僅獲得 PD4 課程將會很困難。他們希望將主題產品放在同一個市場籃子裡。實際上，考慮到 ZORYVE 的差異化，這對我們來說是有利的，不僅在於資產，還在於我們如何在市場中策略性地為產品定價。因此，您要在市場中採取策略性定價，同時也要考慮到每位患者每年平均使用兩到三根導管。我們對 D 部分計劃以及受益人而言都具有很大的價值。

I see. Great. And then just one more question. Any new thinking around the ex-US opportunity, especially in Europe based on how Opzelura is performing?

我懂了。偉大的。還有一個問題。根據 Opzelura 的表現，您對美國以外的機會有什麼新想法，尤其是歐洲的機會嗎？

I would say at this point, no change. I think that Opzelura is really a distinct situation, especially because of the label they have in Europe and the lack of comparators for that indication in Europe. I think for ZORYVE and some of the other advanced topical therapies, the reimbursement landscape in Europe is particularly challenging.

我想說，目前為止，沒有改變。我認為 Opzelura 的情況確實很獨特，特別是因為他們在歐洲的標籤以及歐洲缺乏針對該適應症的比較器。我認為對於 ZORYVE 和其他一些先進的局部療法來說，歐洲的報銷情況尤其具有挑戰性。

And you lay on top of that some of the potential domestic risks around MSN pricing, and we feel that the business case right now in Europe isn't compelling enough for us to pursue that.

除此之外，您也提到了 MSN 定價方面的一些潛在國內風險，我們認為目前歐洲的商業案例還不足以讓我們追求這一目標。

Thank you. And I would now like to hand the conference back over to Frank Watanabe for closing remarks.

謝謝。現在我想將會議交還給弗蘭克·渡邊（Frank Watanabe）作閉幕發言。

Okay. Well, as always, we appreciate all the great questions and appreciate you guys making the time to join us on the call today. I know it's a very, very busy time of the year. So we look forward to talking to you all again in another quarter and hopefully putting up another great number next quarter. Thanks again.

好的。好吧，和往常一樣，我們感謝大家提出的所有重要問題，也感謝你們今天抽出時間來參加我們的電話會議。我知道這是一年中非常非常忙碌的時刻。因此，我們期待在另一個季度再次與大家交談，並希望在下個季度再創佳績。再次感謝。

This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。祝大家有個愉快的一天。