Arcutis Biotherapeutics Inc (ARQT) 2025 Q1 法說會逐字稿

Good day, and welcome to Arcutis Biotherapeutics 2025 first-quarter financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the call over to Amanda Sheldon. Please go ahead.

大家好，歡迎參加 Arcutis Biotherapeutics 2025 年第一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。現在我想把電話交給阿曼達·謝爾頓。請繼續。

Thank you, Heidi. Good afternoon, everyone, and thank you for joining us today to review our first quarter 2025 financial results and business update. Slides for today's call are available on the Investors section of the Arcutis website. 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. I would like to remind everyone that we will be making forward-looking statements during this call.

謝謝你，海蒂。大家下午好，感謝您今天加入我們，回顧我們 2025 年第一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。參加今天電話會議的有總裁兼首席執行官 Frank Watanabe；帕特里克·伯內特 (Patrick Burnett)，首席醫療官；托德·愛德華茲（Todd Edwards），首席商務官；和首席財務官 Latha Vairavan。我想提醒大家，我們將在本次電話會議中做出前瞻性陳述。

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.

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。

Thank you, Amanda, and thank you to everyone for joining us today. Before I delve into the quarterly details, I want to take a moment to thank David Topper, who will retire in a couple of weeks, for his many important contributions to Arcutis, both in his time as our CFO and during his many years as a consultant to our company. We wish him all the best in this next stage of life. And I am very pleased to welcome Latha Vairavan to our first earnings call as our CFO, a role she officially assumed this morning. Latha has been an integral part of our team for many years, and she is fully prepared to step up to this new role.

謝謝你，阿曼達，也感謝今天與我們一起的所有人。在深入探討季度細節之前，我想花點時間感謝幾週後退休的 David Topper，感謝他在擔任我們的財務長期間以及擔任我們公司顧問的多年期間為 Arcutis 做出的許多重要貢獻。我們祝福他在人生的下一個階段一切順利。我非常高興地歡迎 Latha Vairavan 以首席財務官的身份參加我們的首次財報電話會議，她今天早上正式上任這一職位。多年來，Latha 一直是我們團隊不可或缺的一部分，她已做好充分準備擔任這個新角色。

I could not be more excited about her joining our senior leadership team. Turning to our results. If you take nothing else away from our call today, I want to highlight four key points. First, our team continues to execute exceptionally well, most notably our commercial and R&D teams, as evidenced by yet another strong quarter performance across our portfolio and our continued progress in advancing our pipeline.

我對她加入我們的高階領導團隊感到非常興奮。談談我們的結果。如果您對我們今天的通話沒有其他任何收穫，我想強調四個要點。首先，我們的團隊繼續表現出色，最引人注目的是我們的商務和研發團隊，這從我們整個投資組合在本季度的又一次強勁表現以及我們在推進產品線方面的持續進展中可以看出。

Second, with multiple upcoming catalysts and expanding markets, we are confident in our ability to sustain our growth throughout 2025 and beyond. Third, the most important of these market expansion opportunities is the conversion from the very large top of the steroid market, and we are seeing tangible signs of growing momentum in that shift. And fourth, we are very pleased with our progress in Q1 in protecting our intellectual property.

其次，隨著多種催化劑的出現和市場的不斷擴大，我們有信心在 2025 年及以後保持成長。第三，這些市場擴張機會中最重要的是從類固醇市場非常龐大的頂部轉變，我們看到了這種轉變中成長動能的明顯跡象。第四，我們對第一季在保護智慧財產權方面的進展感到非常滿意。

I am grateful to work with such a dedicated and stellar team who are building the leading topical franchise, one that is outperforming historical precedents in dermatology. ZORYVE is endowed with a unique combination of attributes, including efficacy and safety, rapid onset, reliability and the ease of use for both clinicians and patients that has allowed us to build a segment-leading franchise.

我很榮幸能與這樣一支敬業而出色的團隊合作，他們正在打造領先的外用特許經營權，其表現超越了皮膚病學的歷史先例。ZORYVE 具有獨特的屬性組合，包括功效和安全性、快速起效、可靠性以及對臨床醫生和患者的易用性，這使我們能夠打造出領先行業的特許經營權。

Let's turn now to slide 5 of the deck. We had a robust start to 2025, and our first quarter performance was very much in line with our expectations. As our results indicate, commercial execution continues to be a key strength of our business, and we expect sustained growth of the ZORYVE portfolio this year and beyond. In the first quarter, we reported revenues of $63.8 million, representing nearly a doubling of revenues year-over-year, excluding the non-recurring reduction in reserves for product returns of $4.1 million, as reported in Q4 of 2024.

現在我們來看投影片的第 5 張。 2025 年我們有一個強勁的開局，第一季的業績非常符合我們的預期。正如我們的結果所顯示的，商業執行仍然是我們業務的主要優勢，我們預計今年及以後 ZORYVE 產品組合將持續成長。第一季度，我們報告的營收為 6,380 萬美元，年增近一倍，不包括 2024 年第四季報告的 410 萬美元的非經常性產品退貨準備金減少。

As is typical for any retail pharmaceutical product, revenues were down compared to the fourth quarter due to the typical first quarter deductible resets and insurance changes. It's really quite remarkable that despite those typical headwinds, our sales were nearly flat, with only a 2% decline versus the prior quarter, which is very unusual compared to other branded topicals, or frankly, nearly every other product on the market where substantial drops Q4 and Q1 are typical.

與任何零售醫藥產品的典型情況一樣，由於第一季典型的免賠額重置和保險變化，收入與第四季度相比有所下降。非常值得注意的是，儘管面臨這些典型的不利因素，我們的銷售額卻幾乎持平，僅比上一季度下降了 2%，這與其他品牌外用藥相比非常不尋常，或者坦率地說，與市場上幾乎所有其他產品相比，第四季度和第一季度的大幅下降都是很常見的。

Impressively, we delivered prescription demand growth of 10% compared to Q4, despite the typical pull forward of demand into Q4 as patients filled prescriptions early in anticipation of their copay resets. Blended gross to nets have remained relatively steady as expected with some minor anticipated quarterly fluctuations related to the reset of patient deductibles and plan changes. And as Q1 progressed, we saw our GTNs quickly trend back down towards steady state.

令人印象深刻的是，儘管由於患者預期共同支付額度重置而提前取藥，導致第四季度的需求提前，但我們的處方需求與第四季度相比仍增長了 10%。正如預期的那樣，混合總額與淨額保持相對穩定，預計與患者免賠額的重置和計劃變更有關的季度波動會有一些小幅波動。隨著第一季的進展，我們看到 GTN 迅速回落至穩定狀態。

The vast majority of patients with psoriasis, AD and seb derm are currently treated with topical steroids, so there is an immense opportunity for future growth of ZORYVE across our indications. And as Patrick and Todd will discuss more in just a few minutes, during Q1, we saw clear and growing momentum in that shift.

目前，絕大多數牛皮癬、阿茲海默症和脂漏性皮膚炎患者都使用外用類固醇治療，因此 ZORYVE 在未來適應症領域的成長潛力巨大。正如帕特里克和托德幾分鐘後將進一步討論的那樣，在第一季度，我們看到了這種轉變的明顯且不斷增長的勢頭。

We expect to further expand ZORYVE's approved indications in 2025, beginning with the anticipated May 22 approval of ZORYVE foam for scalp and body psoriasis. We are also eagerly anticipating another approval for ZORYVE cream, this time a 0.05% concentration for atopic dermatitis in children ages two to five, with an expected approval in October.

我們預計將在 2025 年進一步擴大 ZORYVE 的核准適應症，首先是預計於 5 月 22 日批准用於治療頭皮和身體牛皮癬的 ZORYVE 泡沫。我們也熱切期待 ZORYVE 乳膏再次獲得批准，此次的濃度為 0.05%，適用於 2 至 5 歲兒童的異位性皮膚炎，預計 10 月獲得批准。

Finally, we announced in April that at the request of Padagis, we had agreed to a joint stipulation to stay the ongoing patent litigation with them over their topical roflumilast ANDA. We agreed to this because it extends the 30-month stay we are entitled to under Hatch-Waxman for as long as the Padagis requested stay in the case remains in place, and it also allows us to delay or even avoid the cost of litigation and the distraction of litigation.

最後，我們在四月份宣布，應Padagis的要求，我們已同意一項聯合協議，暫停與他們就外用羅氟司特ANDA進行的專利訴訟。我們同意這樣做，因為只要帕達吉斯要求的案件中止期限仍然有效，它就可以延長我們根據《哈奇-瓦克斯曼法案》享有的 30 個月的中止期限，而且它還可以讓我們延遲甚至避免訴訟費用和訴訟幹擾。

Let me be clear, we are not and have not previously been in any settlement discussions with Padagis. We have not wavered in our confidence in the strength and breadth of our patent portfolio that reflects the innovations we have generated since our company's inception. We are confident in our legal position against Padagis. If and when the stay is lifted, we will continue to fight against Padagis' attempts to circumvent our legally issued patents on our psoriasis cream.

讓我明確一點，我們現在沒有與 Padagis 進行任何和解談判，之前也沒有。我們對我們的專利組合的實力和廣度的信心從未動搖，它反映了我們自公司成立以來所創造的創新。我們對自己對抗帕達吉斯的法律地位充滿信心。如果禁令解除，我們將繼續打擊 Padagis 試圖規避我們牛皮癬藥膏合法頒發的專利的行為。

Now turning to slide 6, touching again on the immensity of our target market of 17 million patients. The size of this opportunity, coupled with ZORYVE's unique and compelling value proposition, provides us with strong conviction in our ability to continue to grow our product portfolio beyond what has historically been typical with other topical brands.

現在翻到第 6 張投影片，再次觸及我們 1,700 萬名患者的龐大目標市場。這一機會的規模，加上 ZORYVE 獨特且引人注目的價值主張，使我們堅信我們有能力繼續擴大我們的產品組合，超越其他主題品牌歷史上的典型水平。

Patrick, Todd, and I were out visiting clinicians all last week, and the feedback we heard from them on ZORYVE's performance is outstanding, only adding to our confidence in ZORYVE's future potential. As we've shared in the past, half of the treated patients in our targeted indications are treated in the derm setting and the other half are being treated outside of the dermatology office, primarily by primary care physicians and pediatricians.

派崔克、陶德和我上週一直在拜訪臨床醫生，他們對 ZORYVE 的表現給予了非常出色的回饋，這更增強了我們對 ZORYVE 未來潛力的信心。正如我們過去所分享的，我們針對的適應症中有一半接受治療的患者在皮膚科接受治療，另一半在皮膚科診所外接受治療，主要由初級保健醫生和兒科醫生接受治療。

Our launches thus far, along with our upcoming launches if approved, continuously expanding coverage and the Kowa commercial partnership enable us to access the entire 17 million patient opportunity, another unique feature in the branded topical space. But as shown on the chart on the right, 94% of topical prescriptions written for our target patients are still for topical steroids, topical calcineurin inhibitors, antifungals and vitamin D analogs. Our long-term growth relies on shifting this use to ZORYVE as the go-to topical treatment.

我們迄今為止推出的產品以及即將推出的產品（如果獲得批准）、不斷擴大的覆蓋範圍以及與 Kowa 的商業合作夥伴關係使我們能夠獲得全部 1700 萬患者的機會，這是品牌外用領域的另一個獨特之處。但如右圖所示，我們為目標患者開立的外用處方中 94% 仍然是外用類固醇、外用鈣調神經磷酸酶抑制劑、抗真菌藥物和維生素 D 類似物。我們的長期成長依賴於將這種用途轉變為 ZORYVE 作為首選的局部治療方法。

Encouragingly, we are seeing growing evidence that dermatology clinicians are starting to shift away from these products, and as the leading branded non-steroidal, ZORYVE is positioned to be the primary beneficiary of that shift. Todd and Patrick will delve deeper into the evidence we are seeing of this growing shift, and Todd will go into further detail on how we view revenue and script growth trends evolving throughout 2025. Arcutis as a company has had the good fortune to be presented with a rare opportunity, combining an immense market with a strong and well-recognized brand, which can create significant value for all of our stakeholders. Our team recognizes the uniqueness of our compelling position and remains highly focused on growing ZORYVE to its peak sales potential.

令人鼓舞的是，我們看到越來越多的證據表明皮膚科臨床醫生開始遠離這些產品，而作為領先的非類固醇品牌，ZORYVE 將成為這種轉變的主要受益者。托德和帕特里克將深入探討我們看到的這種日益增長的轉變的證據，托德將進一步詳細說明我們如何看待 2025 年全年的收入和腳本增長趨勢。 Arcutis 作為一家公司，很榮幸獲得了一個難得的機會，將巨大的市場與強大且知名的品牌結合起來，這可以為我們所有的利益相關者創造巨大的價值。我們的團隊認識到我們引人注目的地位的獨特性，並高度專注於將 ZORYVE 發展到其最高的銷售潛力。

With that, let me turn it over to Todd to provide some more color on where we are in our launch and how we will continue to execute on our vision.

接下來，讓我將時間交給 Todd，讓他進一步介紹我們目前的發布情況以及我們將如何繼續實現我們的願景。

Thank you, Frank. In Q1, once again, we delivered strong sales results, leveraging the strength of our product portfolio, and are pleased by the continued positive response to ZORYVE from HCPs and patients, and excited by the growth opportunities ahead of us. On slide 8, this quarter, we achieved $68.3 million in net product revenue for ZORYVE, reflecting a 196% growth year-over-year. Importantly, we saw strong sequential volume growth, and our blended gross to net remained in the 50% range, even with the typical temporary reversion and gross to net compared to Q4 2024.

謝謝你，弗蘭克。在第一季度，我們再次取得了強勁的銷售業績，得益於我們產品組合的優勢，我們對 HCP 和患者對 ZORYVE 的持續積極響應感到高興，並對我們未來的成長機會感到興奮。在第 8 張投影片中，本季度，ZORYVE 的淨產品收入達到 6,830 萬美元，年增 196%。重要的是，我們看到了強勁的連續交易量成長，即使與 2024 年第四季相比出現了典型的暫時性回歸和總淨額成長，我們的混合總淨額仍保持在 50% 的範圍內。

All commercial stage companies face challenges in the first quarter due to deductible resets, changes in patient insurance plans and prescription refills pulled forward into December. ZORYVE is not exempt from these challenges, and we did see some impact on Q1 revenue, but we are delighted that these had minimal impact on our Q1 performance with only a slight decline in net sales compared to Q4. We are particularly pleased that despite these customary headwinds, ZORYVE unit demand grew 10% quarter-over-quarter. Encouragingly, prescription trends in Q2 point to sustained growth continuing from Q1 and foretell solid performance for the remainder of the year with expected volume and revenue growth throughout 2025.

由於免賠額重置、患者保險計劃的變化以及處方續藥提前至 12 月，所有商業階段公司在第一季都面臨挑戰。 ZORYVE 也未能免受這些挑戰的影響，我們確實看到第一季的營收受到了一些影響，但我們很高興看到這些影響對我們第一季的業績影響甚微，淨銷售額與第四季相比僅略有下降。我們特別高興的是，儘管面臨這些常見的不利因素，ZORYVE 的單位需求仍較上季增加了 10%。令人鼓舞的是，第二季度的處方趨勢表明，成長勢頭將推遲第一季度，並預示著今年剩餘時間的穩健表現，預計 2025 年全年的銷量和收入都將增長。

On slide 9, you can see that ZORYVE prescription volume has reached another record high at 17,000 weekly scripts on a rolling four-week average basis. In 2024, growth inflections were driven by the launches of ZORYVE foam for seborrheic dermatitis and ZORYVE cream 0.15% for atopic dermatitis.

在投影片 9 上，您可以看到 ZORYVE 的處方量已創下新高，四周平均每週處方量達到 17,000 份。2024 年，用於治療脂漏性皮膚炎的 ZORYVE 泡沫和用於治療異位性皮膚炎的 ZORYVE 0.15% 乳膏的推出推動了成長拐點。

Looking towards 2025, later this month, we anticipate the addition of a psoriasis body and scalp indication for the foam formulation, pending approval. We expect this additional indication will reinforce our strong growth trend, although we would not anticipate the same magnitude of growth acceleration as with the seb derm launch. Furthermore, we anticipate another label expansion in October, adding atopic dermatitis in ages two to five, which should be an additional catalyst for growth.

展望 2025 年，本月晚些時候，我們預計泡沫配方將增加牛皮癬身體和頭皮適應症，等待批准。我們預計這一額外適應症將加強我們強勁的成長趨勢，儘管我們預計其成長加速不會達到與 Seb Derm 上市時相同的幅度。此外，我們預計 10 月將再次擴展標籤，增加 2 至 5 歲兒童的異位性皮膚炎，這將成為成長的額外催化劑。

As expected, prescription volume declined from December to January due to the expected pull-forward of refills into December. However, ZORYVE quickly rebounded within weeks, recovering from the early dip and delivering growth across the entire portfolio. We expect this positive trend to continue as we gain share in the large topical steroid market.

正如預期的那樣，由於預計續藥時間將提前至 12 月，因此 12 月至 1 月的處方量有所下降。然而，ZORYVE 在幾週內迅速反彈，從早期的下跌中恢復過來，並實現了整個投資組合的成長。我們預計，隨著我們在大型外用類固醇市場的份額不斷增加，這種積極趨勢將會持續下去。

On slide 10, we highlighted our strong and robust insurance coverage. On the left, you'll see that we've achieved a remarkable position in terms of insurance reimbursement with approximately 80% of total ZORYVE prescriptions being reimbursed, a steady state and optimal level across the portfolio. Since our last update, we've further broadened payer access for atopic dermatitis, which is now largely in line with psoriasis and seb derm coverage, and we expect to see further improvement in gross to net for this indication. In addition, we have secured expanded Medicaid coverage and established a strong presence.

在第 10 張投影片上，我們強調了我們強大而穩健的保險覆蓋範圍。在左側，您會看到我們在保險報銷方面取得了顯著的成績，ZORYVE 處方總額的約 80% 都得到了報銷，整個產品組合都處於穩定狀態和最佳水平。自上次更新以來，我們進一步擴大了異位性皮膚炎的付款人管道，目前已基本與牛皮癬和脂漏性皮膚炎的覆蓋範圍一致，我們預計該適應症的毛收入與淨收入將進一步改善。此外，我們還確保擴大醫療補助覆蓋範圍並建立了強大的影響力。

ZORYVE is now covered with a single step through a steroid or better for 53% of state Medicaid lives, and we've seen strong quarter-over-quarter unit growth in this channel. The other point I want to highlight on this slide is that the profitability of our ZORYVE franchise continues to improve, driven by the high rate of reimbursed prescriptions across the portfolio. This positions us well for the future as we continue to grow prescription volume in 2025 and beyond, and we expect revenue to scale proportionately with that growth.

目前，53% 的州醫療補助受益者只需使用類固醇或更好的藥物即可獲得 ZORYVE 的保障，而且我們看到該管道的季度環比增長強勁。我想在這張投影片上強調的另一點是，我們的 ZORYVE 特許經營權的獲利能力持續提高，這得益於整個產品組合中高報銷處方率的推動。這為我們的未來做好了準備，因為我們將在 2025 年及以後繼續增加處方量，並且我們預計收入將隨著這種增長成比例地擴大。

Our commercial partner, Kowa, continues to make steady progress within the targeted primary care and pediatric segments. As expected, the primary care selling cycle requires more frequent engagements to build familiarity, given that many providers have limited exposure to topical non-steroidal treatments and historically default the steroid use.

我們的商業合作夥伴 Kowa 在目標初級保健和兒科領域繼續取得穩步進展。正如預期的那樣，由於許多供應商對局部非類固醇類藥物治療的接觸有限，並且歷史上默認使用類固醇，因此初級保健銷售週期需要更頻繁的接觸來建立熟悉度。

Physician feedback has been encouraging as education efforts increase, highlighting ZORYVE's unique profile as a safe, effective non-steroidal option that they can be used anywhere on the body for any duration with exceptional tolerability. Importantly, with recent changes to the prescription process, the ease and reliability of prescription fulfillment will be a key differentiator with both physicians and staff. We remain confident in Kowa's ability to expand adoption in primary care. And we're already seeing positive indicators from early prescriber uptake, an encouraging signal for growth in this large and relatively untapped segment.

隨著教育力度的加大，醫生的回饋令人鼓舞，強調了 ZORYVE 作為一種安全、有效的非類固醇藥物的獨特特性，它們可以在身體的任何部位使用任意時間，並具有出色的耐受性。重要的是，隨著處方流程的最新變化，處方執行的簡易性和可靠性將成為醫生和工作人員的關鍵區別因素。我們仍然對 Kowa 擴大初級保健應用的能力充滿信心。我們已經看到了早期處方醫生的積極跡象，這對這個龐大且相對尚未開發的領域的增長來說是一個令人鼓舞的信號。

On slide 12, I'd like to draw your attention to the left side of the slide. We are on a mission to convert steroid prescriptions to ZORYVE and to expand the overall branded topical market. As you can see, the immense topical steroid market has declined by 200 basis points over the past year, with that share being captured by branded topicals led by ZORYVE. This is an early but meaningful sign of our success, and Patrick will delve into the drivers behind this in a moment.

在第 12 張投影片上，我想請大家注意投影片的左側。我們的使命是將類固醇處方轉換為 ZORYVE，並擴大整體品牌外用藥市場。如您所見，龐大的外用類固醇市場在過去一年中下降了 200 個基點，而這一份額被以 ZORYVE 為首的品牌外用藥物所佔據。這是我們成功的早期但有意義的標誌，帕特里克稍後將深入探討背後的驅動因素。

Keep in mind, branded topicals still represent only a small portion of the overall market, which highlights the immense opportunity ahead for ZORYVE as clinicians continue to transition from steroids to non-steroid treatments, a trend we expect to accelerate. I'm excited to share tangible evidence of our momentum.

請記住，品牌外用藥物仍然只佔整個市場的一小部分，這凸顯了 ZORYVE 未來的巨大機遇，因為臨床醫生繼續從類固醇治療轉向非類固醇治療，我們預計這一趨勢將會加速。我很高興與大家分享我們發展勢頭的實際證據。

ZORYVE has continued to expand its leadership as the #1 branded non-steroidal topical. In the most recent week, ZORYVE captured a 41% share of that segment. On the right side of the slide, you'll see how ZORYVE is consistently gaining share, further validating our growth trajectory.

ZORYVE 作為第一品牌非類固醇用藥，繼續擴大其領導地位。最近一周，ZORYVE 佔據了該領域 41% 的份額。在幻燈片的右側，您將看到 ZORYVE 如何持續獲得份額，進一步驗證我們的成長軌跡。

On slide 13, as we've emphasized over the past several quarters, ZORYVE is uniquely positioned in the topical arena with multiple formulations to treat three major inflammatory skin conditions, and a fourth indication for foam scalp and body psoriasis is pending with the PDUFA date set for May 22. ZORYVE stands out for its rapid, reliable relief, its ability to be applied anywhere on the body, used for any duration and its exceptional tolerability.

在第 13 張投影片上，正如我們在過去幾季所強調的那樣，ZORYVE 在外用領域具有獨特的地位，擁有多種配方，可治療三種主要發炎性皮膚病，第四種適應症為泡沫頭皮和身體牛皮癬，PDUFA 日期定於 5 月 22 日。ZORYVE 因其快速、可靠的緩解、可應用於身體任何部位、可使用任意時間以及卓越的耐受性而脫穎而出。

It offers a simple once-daily regimen with predictable patient access through consistent reimbursement and copay support. This growing portfolio effect allows dermatologists to take a personalized, multifaceted approach to managing complex skin conditions, making ZORYVE their go-to treatment solution across indications.

它提供簡單的每日一次治療方案，透過持續的報銷和共同支付支持，患者可以進行可預測的治療。這種不斷增長的產品組合效應使皮膚科醫生能夠採取個人化、多方面的方法來管理複雜的皮膚狀況，使 ZORYVE 成為各種適應症的首選治療方案。

On slide 14, I'd like to delve into a recent analysis we conducted on prescribing behavior among clinicians. Unsurprisingly, we found that clinicians who prescribe ZORYVE across multiple indications write significantly more prescriptions overall. But what is remarkable is the evidence of the portfolio effect that I mentioned previously.

在第 14 張投影片上，我想深入探討我們最近對臨床醫生的處方行為進行的分析。毫不奇怪，我們發現，針對多種適應症開立 ZORYVE 的臨床醫生總體上開出的處方明顯更多。但值得注意的是我之前提到的投資組合效應的證據。

As these healthcare providers recognize the value ZORYVE brings to patients, they're able to expand its use across a broader portion of their practice. For example, clinicians treating only one indication averaged three prescriptions per prescriber, while those prescribing for all three indications averaged 31 prescriptions per prescriber, a ten-fold increase. We expect this amplification to increase further with the potential approval of our foam formulation for body and scalp psoriasis.

隨著這些醫療保健提供者認識到 ZORYVE 為患者帶來的價值，他們能夠將其用途擴展到更廣泛的實踐領域。例如，僅治療一種疾病的臨床醫生平均每位開立 3 張處方，而治療所有三種疾病的臨床醫生平均每位開立 31 張處方，增加了 10 倍。我們預計，隨著我們的泡沫配方用於治療身體和頭皮牛皮癬的潛在批准，這種放大效應將進一步增強。

With that, I'll now turn it over to Patrick for an R&D update.

說完這些，我現在將把研發更新交給派崔克。

Thank you, Todd. I'm on slide 16. We're now approaching several key milestones in 2025. And first, we have the FDA PDUFA target action date for ZORYVE foam for plaque psoriasis of the scalp and body down to the age of 12 on May 22, 2025, and we're highly optimistic about an on-time approval there. Second, we have an anticipated approval in October for ZORYVE cream 0.05%, a dose specifically developed for the treatment of mild to moderate AD in 2- to 5-year olds.

謝謝你，托德。我在第 16 張投影片。我們即將迎來 2025 年的幾個關鍵里程碑。首先，FDA PDUFA 規定的 12 歲以下頭皮和身體斑塊性乾癬的 ZORYVE 泡沫的目標作用日期為 2025 年 5 月 22 日，我們對按時獲得批准非常樂觀。其次，我們預計將於 10 月批准 ZORYVE 0.05% 乳膏，該劑量專門用於治療 2 至 5 歲兒童的輕度至中度 AD。

We also continue to generate the necessary additional data that should ultimately support expanding the psoriasis indication down to the age of two as well. In our early stage pipeline, we look forward to the Phase 1b readout for ARQ-255, our topical JAK in alopecia areata, around the middle of 2025. We expect to file the IND for ARQ-234, our biologic CD200 receptor agonist for atopic dermatitis, in the second half of 2025.

我們也將繼續產生必要的附加數據，最終支持將牛皮癬的適應症擴大到兩歲。在我們的早期研發管線中，我們期待在 2025 年中期獲得 ARQ-255（我們的斑禿局部 JAK）的 1b 期讀數。我們預計將於 2025 年下半年提交用於治療異位性皮膚炎的生物 CD200 受體激動劑 ARQ-234 的 IND。

Now moving on to slide 17. We've been talking to you for several quarters about the growing momentum among clinicians for a shift away from steroids toward non-steroidal topical agents that are safer for long-term use for these chronic conditions, and in Q1, there were a number of notable events that really prove out and highlight that trend. For example, in January, a panel of some of the leading dermatology experts in the US published consensus guidelines on the use of topical steroids as well as recommendations for the incorporation of advanced targeted topicals into the treatment regimen.

現在翻到第 17 張投影片。幾個季度以來，我們一直在與您討論臨床醫生越來越傾向於從類固醇轉向更安全的長期用於治療慢性疾病的非甾體外用藥物，而在第一季度，發生了許多值得注意的事件，真正證明並突顯了這一趨勢。例如，今年一月，美國一些頂尖皮膚病學專家組成的專家小組發布了關於使用外用類固醇的共識指南，並提出了將先進的有針對性的外用藥物納入治療方案的建議。

I would call your attention to that group's conclusions shown on the lower left of the slide. Similarly during Q1, a journal targeted to dermatology NPs and PAs published an extensive review on steroid safety concerns. And again, I would point you to the conclusions of that paper shown on the lower right. These are powerful calls to action from dermatology clinicians directed toward their dermatology colleagues. And these are only two of several recent research reports and publications highlighting the risk and cumulative effect of steroids.

我想請大家注意幻燈片左下角顯示的該小組的結論。同樣，在第一季度，針對皮膚科 NP 和 PA 的期刊發表了一篇關於類固醇安全​​問題的廣泛評論。再次，我想向大家指出右下角顯示的該論文的結論。這是皮膚科臨床醫師向皮膚科同事發出的強而有力的行動呼籲。這只是最近幾份強調類固醇的風險和累積效應的研究報告和出版物中的兩份。

Last month, new Canadian consensus guidelines for the topical treatment of atopic dermatitis were published, recommending that steroids be reserved for short-term use due to greater risk of adverse events, including skin atrophy, hypopigmentation and other systemic effects. And in March, the NIH published research that identified for the first time the pathophysiology of topical steroid withdrawal, also called TSW. This is a condition caused by long-term steroid use that leads to redness, itching and scaling, which can be difficult to distinguish from the underlying skin disease that was originally being treated by the steroid. As more evidence emerges for how the cessation of long-term topical steroid use can result in TSW, as well as criteria to help distinguish this condition from eczema, we expect more opportunities for the treatment of this condition will emerge as well.

上個月，加拿大發布了針對異位性皮膚炎局部治療的新共識指南，建議將類固醇保留用於短期使用，因為類固醇的不良事件風險較大，包括皮膚萎縮、色素減退和其他全身性影響。今年 3 月，美國國立衛生研究院發表了一項研究，首次確定了局部類固醇戒斷（也稱為 TSW）的病理生理學。這是長期使用類固醇引起的疾病，會導致發紅、搔癢和脫屑，很難與最初使用類固醇治療的潛在皮膚病區分開來。隨著越來越多的證據表明停止長期局部使用類固醇會導致 TSW，以及有助於區分這種疾病和濕疹的標準，我們預計治療這種疾病的更多機會也會出現。

Now on slide 18, turning to our expected upcoming indication for scalp and body psoriasis. I wanted to share with you some impactful images of the benefits of our investigational ZORYVE foam in treating psoriasis of the scalp and body from our ARRECTOR clinical trial. In the top row, you can see a female patient with significant scalp and neck plaques that were initially rated a score of three, or moderate, on the Investigator Global Assessment, or IGA scale. These lesions were then significantly improved after only two weeks of treatment, and the patient was subsequently rated as an IGA score of zero or clear by eight weeks.

現在在第 18 張投影片上，介紹我們預期即將出現的頭皮和身體牛皮癬適應症。我想與大家分享一些來自我們的 ARRECTOR 臨床試驗的、關於我們正在研究的 ZORYVE 泡沫在治療頭皮和身體牛皮癬方面的益處的有影響力的圖像。在最上面一行，您可以看到一位頭皮和頸部有明顯斑塊的女性患者，其在研究者總體評估（IGA）量表上的初始評分為三分，即中等。僅經過兩週的治療，這些病變就得到顯著改善，且患者的 IGA 評分在八週內被評為零或清晰。

Similar efficacy can be seen in the bottom images of another patient with extensive body psoriasis with thick, brightly erythematous lesions on the back who was likewise treated with ZORYVE foam and dramatically improved from a baseline of moderate psoriasis to also be clear, an IGA of zero, by eight weeks. Now this degree of improvement is quite remarkable and it highlights the strength of ZORYVE foam on both the scalp and the body. And when combined with its ease of use and broad patient access, makes ZORYVE highly compelling to healthcare providers. These results are highly representative of our Phase III trial results in which about two in three individuals achieved scalp IGA success and nearly half achieved body IGA success.

在下圖中可以看到類似的療效，另一名患有廣泛性身體牛皮癬、背部有厚而鮮豔的紅斑病變的患者也接受了 ZORYVE 泡沫治療，並且在八週內從中度牛皮癬的基線顯著改善，並且 IGA 為零。現在這種程度的改善非常顯著，它凸顯了 ZORYVE 泡沫對頭皮和身體的強度。並且，結合其易用性和廣泛的患者可近性，ZORYVE 對醫療保健提供者來說極具吸引力。這些結果高度代表了我們的 III 期試驗結果，其中大約三分之二的個體實現了頭皮 IGA 成功，近一半的個體實現了身體 IGA 成功。

With that, I'll pass it over to Latha.

說完這些，我就把它交給拉莎 (Latha)。

Thank you, Patrick. Before I begin, I want to thank David Topper for his guidance and mentorship over the past year and especially during this transition. I am honored to step into the CFO seat during a very exciting period of Arcutis' commercial growth.

謝謝你，派崔克。在開始之前，我要感謝 David Topper 在過去一年中，特別是在這次過渡期間的指導和輔導。我很榮幸能夠在 Arcutis 商業成長非常令人興奮的時期擔任財務長。

I'm on slide 20, showing financial results both year-over-year and quarter-over-quarter for the first quarter of 2025. We generated net product revenues in the quarter of approximately $63.8 million, which is up 196% from Q1 of 2024. Recall that Q4 2024 number included a non-recurring $4.1 million adjustment for reduction in reserves for product returns.

我現在看到的是第 20 張投影片，展示的是 2025 年第一季的年比和季比財務表現。我們本季的淨產品收入約為 6,380 萬美元，較 2024 年第一季成長 196%。回想一下，2024 年第四季的數字包括一項 410 萬美元的非經常性調整，用於減少產品退貨準備金。

Last quarter, we noted that this number should be excluded from forward-looking calculations. Without this non-recurring revenue, net product revenues only declined by 2% quarter-over-quarter, reflecting the healthy state of our launches. I will remind you that in Q1 2024, we executed an out-license deal in Japan with Sato, which brought in $25 million of non-dilutive capital, and we also received $3 million milestone payment from our Chinese partner, Huadong. This quarter, we received another milestone payment from Huadong of $2 million.

上個季度，我們注意到這個數字應該被排除在前瞻性計算之外。如果沒有這筆非經常性收入，淨產品收入僅比上一季下降 2%，這反映了我們產品發布的健康狀況。我要提醒您的是，2024 年第一季度，我們與日本佐藤公司簽訂了一項對外許可協議，帶來了 2500 萬美元的非稀釋性資本，同時我們還從中國合作夥伴華東公司獲得了 300 萬美元的里程碑付款。本季度，我們又收到華東的 200 萬美元里程碑付款。

Cost of sales in the first quarter were $8.8 million compared to $3.3 million in 2024, primarily due to catch-up amortization of the $10 million owed to AstraZeneca for reaching a sales milestone of $250 million of cumulative net sales. For the first quarter of 2025, our R&D expenses were $17.5 million, which is down 24% from $23.1 million in the first quarter of 2024 due to decreases in the development cost of topical roflumilast programs and approximately 21% compared to the fourth quarter of 2024. Recall that Q4 2024 benefited from a onetime $3 million credit we received related to a closeout of our roflumilast study.

第一季的銷售成本為 880 萬美元，而 2024 年為 330 萬美元，這主要是由於累計淨銷售額達到 2.5 億美元的銷售里程碑而欠​​阿斯利康的 1000 萬美元的補繳攤銷。2025 年第一季度，我們的研發費用為 1,750 萬美元，較 2024 年第一季的 2,310 萬美元下降 24%，原因是外用羅氟司特專案的開發成本下降，與 2024 年第四季相比下降約 21%。回想一下，2024 年第四季我們獲得了與羅氟司特研究結束相關的一次性 300 萬美元信貸。

SG&A expenses were $64 million for the first quarter of 2025 versus $54.8 million in the same period last year, up 17% as we invested in our commercial organization and our current and future launches. SG&A expenses were also up approximately 11% as compared to the fourth quarter of 2024, primarily due to higher promotional spend for our current and upcoming ZORYVE launches.

2025 年第一季的銷售、一般及行政費用為 6,400 萬美元，而去年同期為 5,480 萬美元，成長 17%，因為我們對商業組織以及當前和未來的推出進行了投資。與 2024 年第四季相比，銷售、一般及行政費用也增加了約 11%，這主要是由於我們目前和即將推出的 ZORYVE 的促銷支出增加。

Our SG&A spend in Q2 will be higher than Q1 associated with the scalp and body psoriasis launch and then normalize in the second half of the year. We expect this stable level to carry into 2026. This expense stabilization, combined with the tremendous growth potential of our ZORYVE portfolio, gives us continued confidence that we can reach cash breakeven in 2026. I want to take a moment to comment on the impact of tariffs on our business.

由於頭皮和身體牛皮癬產品的推出，我們第二季度的銷售、一般及行政開支將高於第一季度，然後在下半年恢復正常。我們預計這一穩定水準將持續到 2026 年。這種費用穩定，加上我們 ZORYVE 產品組合的巨大成長潛力，使我們有信心在 2026 年實現現金收支平衡。我想花點時間評論一下關稅對我們業務的影響。

We are a global operation with sales in the United States and Canada. All of our intellectual property for ZORYVE is domiciled in the United States. We currently manufacture the majority of our product in the U.S., and our API is sourced from Spain. We have also started manufacturing at a facility in Canada to mitigate any supply chain risks. As we have previously mentioned, our cost of sales is pharma-like. And if a tariff were applied to our entire unit cost, it would be immaterial, estimated to be less than a 1 percentage point impact on our cost of sales.

我們是一家全球性企業，銷售範圍涵蓋美國和加拿大。 ZORYVE 的所有智慧財產權均位於美國。目前，我們大部分產品都在美國生產，API 來自西班牙。我們也開始在加拿大的一家工廠進行生產，以減輕供應鏈風險。正如我們之前提到的，我們的銷售成本與製藥業類似。如果對我們的整個單位成本徵收關稅，那將無關緊要，估計對我們的銷售成本的影響不到 1 個百分點。

The impact of tariffs on Arcutis will likely be no greater than on any other pharma company and substantially less than many. So we do not anticipate there will be a significant issue for Arcutis, particularly compared to our peers with extensive non-US manufacturing networks and/or a significant portion of their intellectual property held overseas.

關稅對 Arcutis 的影響可能不會比對其他製藥公司的影響更大，而且比許多公司的影響要小得多。因此，我們預計 Arcutis 不會遇到重大問題，尤其是與擁有廣泛的非美國製造網絡和/或其大部分智慧財產權在海外的同行相比。

I am now on slide 21. You can see we had cash and marketable securities of $198.7 million on our balance sheet as of March 31, 2025, which translates to a cash burn from operations in the quarter of approximately $30 million. Q4 2024 had several onetime anomalies that benefited our cash burn for the quarter, for we are back to a more typical use of cash. Q1 burn was still lower than that of Q3 2024, and we expect our quarterly cash burn to continue trending downward as our revenues grow and we approach cash flow breakeven sometime in 2026.

我現在在第 21 張投影片。您可以看到，截至 2025 年 3 月 31 日，我們的資產負債表上有 1.987 億美元的現金和有價證券，這意味著本季營運現金消耗約為 3,000 萬美元。 2024 年第四季出現了幾次一次性異常，這對我們本季的現金消耗有利，因為我們又回到了更典型的現金使用方式。第一季的現金消耗仍低於 2024 年第三季的現金消耗，我們預計，隨著收入的增長以及我們在 2026 年某個時候接近現金流盈虧平衡，我們的季度現金消耗將繼續呈下降趨勢。

We have total debt of $107.6 million and have the option to withdraw $100 million, in whole or in part, at our discretion through the middle of 2026, providing us with significantly enhanced flexibility. The success of our 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.

我們的總債務為 1.076 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 1 億美元，這為我們提供了大大增強的靈活性。ZORYVE 產品組合的成功以及我們正在產生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 will hand it back to Frank for some closing comments.

說完這些，我將把話題交還給法蘭克，請他發表一些結束語。

Thanks, Latha. I will finish up where I began. Arcutis continues to execute exceptionally well, driving growth of ZORYVE and advancing our pipeline. We are confident in our ability to sustain our growth throughout 2025 and beyond, considering all of the opportunities ahead of us.

謝謝，拉莎。我將完成我開始的地方。Arcutis 繼續表現出色，推動了 ZORYVE 的成長並推進了我們的產品線。考慮到我們面臨的所有機遇，我們有信心在 2025 年及以後保持成長。

We are seeing tangible evidence of an accelerating shift from topical steroids to newer non-steroidals, and we are delighted with our progress in protecting our intellectual property. Our growing revenues, coupled with the strength of our balance sheet, puts us in a strong position to continue investing for the future, and we remain optimistic about achieving cash breakeven in 2026. And with that, we'll open up the call for Q&A.

我們看到了從外用類固醇到新型非類固醇藥物加速轉變的實際證據，我們對在保護智慧財產權方面取得的進展感到高興。我們不斷增長的收入，加上我們強勁的資產負債表，使我們處於有利地位，可以繼續為未來進行投資，並且我們仍然對 2026 年實現現金收支平衡持樂觀態度。有了這些，我們將開始問答環節。

(Operator Instructions)

（操作員指示）

Vikram Purohit, Morgan Stanley.

摩根士丹利的維克拉姆·普羅希特（Vikram Purohit）。

We have two. So first, thinking about the cadence of ZORYVE performance throughout the rest of the year. Is there anything you'd point out on seasonality, cyclicality that we should keep in mind that could impact kind of quarter-over-quarter trends?

我們有兩個。因此，首先，考慮一下 ZORYVE 在今年剩餘時間內的表現節奏。您能否指出一些關於季節性、週期性的問題，我們應該牢記這些問題可能會影響季度環比趨勢？

And then secondly, for the alopecia areata readout expected in the middle of this year, what would you set in terms of expectations for what we can learn and what you hope to see for the product profile?

其次，對於預計在今年年中公佈的斑禿數據，您對於我們可以了解到什麼以及您希望看到什麼樣的產品概況有何期望？

Vikram, good to hear from you. Yes, Todd, can you maybe address the cadence quarter-over-quarter, and then, Patrick, if you could address the 255 readout?

維克拉姆，很高興收到你的來信。是的，托德，你能否解決季度環比節奏問題，然後，帕特里克，你能否解決 255 讀數問題？

Yes. As we experienced last year over the summer months, we do expect a modest seasonal impact to our performance. However, I think what's very important to point out here is that, as mentioned, we'll be launching foam for scalp and body psoriasis.

是的。正如我們去年夏季所經歷的那樣，我們確實預計季節性因素會對我們的業績產生適度的影響。然而，我認為這裡需要指出的非常重要的一點是，正如所提到的，我們將推出用於頭皮和身體牛皮癬的泡沫。

Not only that, we continue to see a positive impact about this portfolio effect that I mentioned earlier, which continues to provide us an opportunity to convert, say, in the steroid market, which is a significant opportunity for us, which will continue to drive revenue growth in 2025. So yes, we will see some seasonality, but we continue to be very positive relative to these other value drivers that we're providing in the market.

不僅如此，我們繼續看到我之前提到的這種投資組合效應的正面影響，這繼續為我們提供了在類固醇市場進行轉變的機會，這對我們來說是一個重要的機會，這將繼續推動2025年的收入成長。所以是的，我們會看到一些季節性，但相對於我們在市場上提供的其他價值驅動因素，我們仍然非常樂觀。

Okay. So picking up on the question, Vikram, for ARQ-255. So this is a Phase 1b trial that we conducted, and it's primarily focused on evaluating safety, tolerability and then pharmacodynamics. We also looked at the PK and had some biomarker work in addition to some kind of early responses that we were looking for clinical response for hair growth. So this is a three-month trial.

好的。那麼，維克拉姆，我們來回答關於 ARQ-255 的問題。這是我們進行的 1b 期試驗，主要著重於評估安全性、耐受性和藥效學。除了尋找毛髮生長的臨床反應的一些早期反應外，我們還研究了 PK 並進行了一些生物標記研究。這是一個為期三個月的試驗。

The primary endpoint for most pivotal trials is six months. So what we're really focused on is just getting an early read on what might be able to be achieved with ARQ-255. So we're really looking forward to reading out the data from this in the middle of 2025.

大多數關鍵試驗的主要終點是六個月。因此，我們真正關注的只是儘早了解 ARQ-255 可以實現什麼目標。因此，我們非常期待在 2025 年中期讀出這些數據。

Seamus Fernandez, Guggenheim Securities.

古根漢證券公司的謝默斯·費爾南德斯。

So Todd, just wanted to get a sense for how the additional scalp psoriasis and body psoriasis opportunity can accelerate and expand the use of ZORYVE foam. Obviously, that's kind of a standout product within the portfolio at this point and continues to be so. Just trying to get a better understanding of how that can potentially expand utilization of the foam more broadly. And is it your view that it will cannibalize cream or expand the market and the overall penetration?

所以托德，只是想了解額外的頭皮牛皮癬和身體牛皮癬機會如何加速和擴大 ZORYVE 泡沫的使用。顯然，這是目前產品組合中出類拔萃的產品，並將繼續如此。只是想更了解如何才能更廣泛地擴大泡沫的利用。您認為它會蠶食奶油市場還是擴大市場和整體滲透率？

Then the second question is actually just help us understand where we are in the lifecycle of ZORYVE as it relates to potential impacts of seasonality, whether or not we would see anything like that, given the mild to moderate treatment opportunity that you have in atopic dermatitis where sometimes in the summer months, we could see some seasonality. But it seems pretty early in the lifecycle of ZORYVE to see an impact there, but just wanted to get your thoughts.

那麼第二個問題實際上只是幫助我們了解我們在 ZORYVE 生命週期中的位置，因為它與季節性的潛在影響有關，我們是否會看到類似的情況，考慮到您在特應性皮膚炎中擁有輕度到中度的治療機會，有時在夏季，我們可能會看到一些季節性。但似乎在 ZORYVE 的生命週期中還處於早期階段，看不到其影響，只是想聽聽您的想法。

Yes. Thank you for the question. So we don't anticipate any meaningful cannibalization of ZORYVE cream 0.3%. And let me be a little bit more specific about that is that we expect a broader and increased utilization of ZORYVE for the psoriasis patient. And specifically what I mean is that ZORYVE offers something that no other competitor can offer relative to the differentiation that I think that both patients and providers will value.

是的。謝謝你的提問。因此，我們預計 ZORYVE 0.3% 乳霜不會出現任何重大蠶食現象。讓我更具體地說，我們期望 ZORYVE 在牛皮癬患者中的應用範圍更廣泛、應用範圍更廣。具體來說，我的意思是，ZORYVE 提供了其他競爭對手無法提供的東西，就差異化而言，我認為患者和提供者都會重視這一點。

And that is that we're going to offer optionality and choice, meaning that once a psoriasis patient is seen by the dermatologists, based upon where that psoriasis is located, as an example, if it's in a hair-bearing area, that that clinician will probably prefer to use the foam given the unique formulation for hair-bearing areas, whether it be the scalp or for -- such as genital psoriasis. If it's on the body, they may select to use the 0.3% cream psoriasis.

這就是我們將提供可選性和選擇性，這意味著一旦牛皮癬患者被皮膚科醫生看診，根據牛皮癬的位置，例如，如果它在有毛髮的區域，那麼臨床醫生可能會更喜歡使用泡沫，因為泡沫具有針對有毛髮區域的獨特配方，無論是頭皮還是 - 例如生殖器牛皮癬。如果是身體上的，他們可能會選擇使用0.3%的牛皮癬藥膏。

But nonetheless, we expect broader, more significant utilization of ZORYVE across the two products given that unique value proposition that we will offer. I will point out though with psoriasis patients, the data suggests that 80% of those patients do have scalp involvement. So we do anticipate increased utilization of the foam for those patients with either scalp or hair involvement.

但儘管如此，鑑於我們將提供的獨特價值主張，我們預計 ZORYVE 在兩款產品中的應用範圍將更加廣泛、更加顯著。不過我要指出的是，對於牛皮癬患者來說，數據顯示 80% 的患者確實有頭皮問題。因此，我們確實預計，對於頭皮或頭髮受到影響的患者，泡沫的使用率會增加。

Moving to your second question relative to seasonality in atopic dermatitis. As mentioned earlier, we will expect some seasonality impact to the product. But nonetheless, we continue to see strong growth of ZORYVE demand across atopic dermatitis and other aspects of the portfolio. But I think what's important to mention that I mentioned on my opening comments is this portfolio effect.

轉到您關於異位性皮膚炎季節性的第二個問題。如前所述，我們預計產品會受到一些季節性的影響。但儘管如此，我們仍然看到 ZORYVE 在異位性皮膚炎和其他產品組合方面的需求強勁成長。但我認為，我在開場白中提到的重要一點是投資組合效應。

We continue to see as more prescribers prescribe across the portfolio, they prescribe more of ZORYVE. And what's important about that is the provider has more experience as they write this product, which creates more efficiencies in their writing, more predictability, not only for the provider but also for the staff, where they can become more efficient and effective in processing those prescriptions. And I believe this portfolio effect that will be compounded by the ZORYVE foam launch for psoriasis will continue to drive strong demand growth over 2025.

我們繼續看到，隨著越來越多的處方者在整個產品組合中開出處方，他們開出的 ZORYVE 處方也越來越多。重要的是，提供者在編寫此產品時擁有更多的經驗，這不僅對提供者而且對工作人員來說，在編寫時創造了更高的效率和更多的可預測性，他們可以更有效率、更有效地處理這些處方。我相信，這種投資組合效應以及用於治療牛皮癬的 ZORYVE 泡沫的推出將在 2025 年繼續推動強勁的需求成長。

Let me just maybe expound just a little bit more on the first point because we get this question a lot. I think it's very unlikely that patients will get switched from the cream to the foam once the foam is approved. So that's cannibalization. I think going forward, what we probably will see is an increased use of the foam in new starts for psoriasis patients, keeping in mind that, as Todd mentioned, about half the patients with psoriasis have scalp involvement.

讓我再稍微闡述第一點，因為我們常常被問到這個問題。我認為，一旦泡沫獲得批准，患者就不太可能從乳膏換成泡沫。這就是蠶食。我認為，展望未來，我們可能會看到泡沫在牛皮癬患者的新治療中的使用增加，請記住，正如托德提到的，大約一半的牛皮癬患者都有頭皮問題。

But I think what's really more important is that none of the other non-steroidal options have a formulation that's suitable for treatment of the scalp. And it's quite challenging to treat scalp psoriasis even with steroids, A, because of safety concerns around proximity to the face and especially the eyes, and B, because there aren't a lot of good steroid formulations that are suitable for the scalp either. So if you're a clinician who's treating a large number of patients who have scalp involvement, ZORYVE foam now being approved, or soon to be approved for scalp psoriasis, gives you a great new option and a great new reason to choose ZORYVE over the other non-steroidals and over the topical steroids that you've historically been using.

但我認為更重要的是，其他非類固醇藥物都沒有適合頭皮治療的配方。即使使用類固醇，治療頭皮牛皮癬也是相當困難的，A，因為靠近臉部，特別是眼睛，存在安全問題，B，因為也沒有很多適合頭皮的優質類固醇配方。因此，如果您是臨床醫生，正在治療大量頭皮受累的患者，現在已獲批或即將獲批用於治療頭皮牛皮癬的 ZORYVE 泡棉將為您提供一個絕佳的新選擇，並且有一個很好的新理由選擇 ZORYVE，而不是其他非類固醇類藥物和您過去一直在使用的外用類固醇。

So we really believe that this is going to be an important element of our continued ability to grow the franchise.

因此，我們確實相信，這將是我們繼續發展特許經營能力的重要因素。

Uy Ear, Mizuho.

尤伊·厄爾，瑞穗。

Congrats on the solid quarter. So maybe first question. Just help us understand the cadence of the gross to net as we go through the year. Understandably that the first half of the year, I think on the fourth quarter, you're expecting sort of maybe on the higher end of the 50s.

恭喜本季業績穩健。所以這可能是第一個問題。只需幫助我們了解全年總額與淨額的變化節奏即可。可以理解的是，我認為今年上半年，也就是第四季度，預計銷售額可能會達到 50 多億美元。

Should we expect that to decline towards the middle and then towards the low end as we approach the end of the year? So that's the first question.

隨著年底的臨近，我們是否應該預期這一數字會下降至中間水平，然後再下降至低端？這是第一個問題。

And the second question is, on one of your slides, I think it's slide 12 where you showed a 4% growth in the topical branded product in first quarter of 2024 and then 6% in this quarter. Given that like VTAMA and ZORYVE cream 0.3% and other products, Opzelura and stuff like that have been in the market at least for the last 4 years, what is it that drove this significant market share?

第二個問題是，在您的一張投影片中，我認為是第 12 張投影片，其中您展示了主題品牌產品在 2024 年第一季的成長率為 4%，而本季的成長率為 6%。鑑於 VTAMA 和 ZORYVE 0.3% 乳膏以及其他產品、Opzelura 等產品至少在過去 4 年內都已在市場上銷售，那麼是什麼推動瞭如此大的市場份額呢？

Todd, do you want to talk about the gross to net trend?

托德，你想談談總額與淨額的趨勢嗎？

Yes, I'll talk about the gross to net trend. As mentioned in the opening comments, we did see some impact on gross to net early in the first quarter due to the deductible resets. But since that time, have seen improvements and are in the steady state of the 50%. We anticipate to remain within the 50% gross to net, although we will see improvement through the year as those deductible resets continue to decrease as we roll through the second, third and fourth quarter of the year and are confident that we'll remain in the 50% range for gross to net.

是的，我將談論總額與淨額的趨勢。正如開篇評論中所提到的，由於免賠額重置，我們確實看到第一季初的總額對淨額產生了一些影響。但從那時起，情況已經有所改善，並且處於 50% 的穩定狀態。我們預計總收入與淨收入的比率將保持在 50% 以內，但隨著我們進入第二、第三和第四季度，這些可扣除額的重置將繼續減少，我們將在全年看到改善，並且有信心我們將總收入與淨收入的比率保持在 50% 以內。

And then with regard to your question about the trend in conversion, I think first of all, it's important to remember that Opzelura has been out for about four years. ZORYVE for psoriasis has only been out for three, and VTAMA's been out for about three. ZORYVE for seb derm has only been out a year, and AD has only been out for about six months. So we're still in very early stages of the process. I think also if you go back to 2021 when Opzelura was approved, the branded non-steroidal market, as I recall, was around 1%.

然後關於你關於轉換趨勢的問題，我認為首先，重要的是要記住 Opzelura 已經推出大約四年了。治療牛皮癬的 ZORYVE 僅問世三年，而 VTAMA 也問世約三年。用於治療脂漏性皮膚炎的 ZORYVE 僅推出一年，而 AD 僅推出約六個月。因此我們仍處於該過程的早期階段。我認為，如果追溯到 2021 年 Opzelura 獲得批准時，我記得品牌非類固醇藥物市場約為 1%。

So you've seen a really dramatic growth in that market over the last four years with the addition of new products and as doctors adopt these products more. I think a 50% increase in a 12-month period is really pretty remarkable and I think speaks to the acceleration of the trend that Patrick and Todd talked about. Clearly, we are working against a fairly ingrained habit, which is the use of topical steroids. But as Patrick mentioned, what we are increasingly hearing is clinicians telling each other that they really need to rethink their use of topical steroids and adopt these newer agents. And so we think that that trend will only continue as they have better options and new options like ZORYVE foam for plaque psoriasis and the expansion of our AD label down to the age of two.

因此，隨著新產品的增加以及醫生越來越多地採用這些產品，您會看到過去四年該市場出現了顯著的成長。我認為 12 個月內成長 50% 確實非常了不起，我認為這說明了 Patrick 和 Todd 所談論的趨勢的加速。顯然，我們正在努力戒除一種根深蒂固的習慣，使用外用類固醇。但正如帕特里克所提到的，我們越來越多地聽到臨床醫生互相告知，他們確實需要重新考慮使用外用類固醇並採用這些較新的藥物。因此，我們認為，這種趨勢將會持續下去，因為他們有更好的選擇和新的選擇，例如用於治療斑塊狀乾癬的 ZORYVE 泡沫，以及將我們的 AD 標籤擴展到兩歲。

Is it just the new -- the addition of the new product that's accelerating this trend, or is it also something else? I guess I just wanted to get a better sense of why all of a sudden, I guess, we see this significant acceleration when other non-topical's been on the market for quite a while as well.

是只是新產品的推出加速了這個趨勢，還是還有其他因素？我想我只是想更好地理解為什麼我們突然看到這種顯著的加速，而其他非主題產品也已經在市場上銷售了很長一段時間。

Yes. Well, I think you have to look at the clinical profile of those non-steroidals. Remember back when the TCIs launched in 2020 -- sorry, in 2000, excuse me. Those two products rapidly ramped up to $600 million in annual sales in their fourth year on the market, and then they got the boxed warning, which has been and continues to be a major impediment to the use of TCIs, especially in children with atopic dermatitis. Those drugs also do have some local tolerability issues, and they're twice a day.

是的。嗯，我認為你必須看看這些非類固醇類藥物的臨床特徵。回想一下 TCI 是在 2020 年推出的——抱歉，是在 2000 年。這兩種產品在上市第四年，年銷售額就迅速攀升至 6 億美元，但隨後卻出現了黑框警告，這一直是 TCI 使用的主要障礙，尤其是對於患有異位性皮膚炎的兒童而言。這些藥物也確實存在一些局部耐受性問題，而且每天服用兩次。

And then you had Eucrisa come out in 2017, as I recall. Clearly, not an optimal non-steroidal that has never been very successful, particularly because of the local tolerability but also fairly limited efficacy and an ointment that's twice a day. So that wasn't a great option either. So it really wasn't until the emergence of Opzelura and then ZORYVE and tapinarof that doctors had really reasonable non-steroidal options that could compete with topical steroids. And I think that's why you've seen this growth from, as I said, about 1% prior to the emergence of the newer advanced topical therapies to 7% in about four years.

我記得，Eucrisa 是在 2017 年推出的。顯然，這不是一種最佳的非類固醇藥物，而且從未取得過很好的效果，特別是因為局部耐受性，而且療效也相當有限，而且每天需要使用兩次藥膏。所以這也不是一個好選擇。因此，直到 Opzelura 以及隨後的 ZORYVE 和 tapinarof 出現後，醫生才有了真正合理的非類固醇類藥物選擇，可以與外用類固醇競爭。我想這就是為什麼你會看到這種增長，正如我所說，在新的先進局部療法出現之前，這一比例約為 1%，但在大約四年內卻增長了 7%。

So really, I think it's all being driven by the clinical profile. And prior to the emergence of these new advanced topical therapies, the only option that doctors really had that were good drugs were topical steroids. It was only thing that's really worked.

所以實際上，我認為這都是由臨床特徵決定的。在這些新的先進局部療法出現之前，醫生唯一真正有效的藥物選擇是局部類固醇。這是唯一真正有效的東西。

Tyler Van Buren, TD Cowen.

泰勒範布倫 (Tyler Van Buren)，TD Cowen。

Can you guys please elaborate on the current split of patients, ZORYVE patients being treated in the derm office versus primary care? And I know you mentioned the 50/50 of the addressable patient population, but is that ultimately where you expect the split of patients to end up? And the second question is, as we think about the Kowa efforts, just maybe you could elaborate on some of the barriers to PCPs prescribing that are different from derms and what tactics Kowa is employing to knock them down in order to contribute to revenues meaningfully this year.

你們能否詳細說明一下目前患者的分佈情況，ZORYVE 患者是在皮膚科診所接受治療還是在初級保健機構接受治療？我知道您提到了可尋址患者群體的比例是 50/50，但這是否是您預期患者比例的最終結果？第二個問題是，當我們思考 Kowa 的努力時，也許您可以詳細說明 PCP 開處方時面臨的一些與皮膚科醫生不同的障礙，以及 Kowa 正在採用哪些策略來消除這些障礙，以便在今年為收入做出有意義的貢獻。

Yes. Thanks, Tyler. Good to hear from you, too. So in terms of the split, the patients split about 50/50 across derm and non-derm settings. And the non-derm settings are primarily primary care and pediatrics.

是的。謝謝，泰勒。我也很高興收到你的來信。因此，就分組而言，皮膚科和非皮膚科的患者分組比例約為 50/50。非皮膚科環境主要是初級保健和兒科。

Today, our business is overwhelmingly dermatology. Remember, our primary care and pediatric efforts are fairly nascent, and it's going to take a little time. Todd will mention -- go into more detail about that in just a minute. I think it's hard to say where we ultimately land. I do think that primary care and pediatrics will over time become major contributors to growth for the franchise.

如今，我們的業務主要集中在皮膚病學領域。請記住，我們的初級保健和兒科工作還處於起步階段，還需要一點時間。托德將會提到——稍後會更詳細地討論這一點。我認為很難說我們最終會落到哪裡。我確實認為初級保健和兒科將隨著時間的推移成為特許經營成長的主要貢獻者。

But I don't know that we'll get to a 50/50 split because there are any number of other dynamics like payer mix that also could factor into it. But I do think it will be an important contributor to growth over the long term. Todd, do you want to talk a little bit about Kowa?

但我不知道我們是否會達到 50/50 的比例，因為還有許多其他動態因素（例如付款人組合）也可能影響這一點。但我確實認為，從長遠來看，它將成為經濟成長的重要動力。托德，你想談談 Kowa 嗎？

Yes, absolutely. Relative to Kowa, Kowa does continue to make steady progress to what I'll call the dynamics of the PCP selling cycle. And we do expect them to have a positive impact to our revenue in 2025. But like all new sales forces or new product launches, especially within primary care, it takes a high level of engagement and frequency with that primary care physician to initiate a trial of the product. So we're confident that Kowa will continue to progress and have that type of impact.

是的，絕對是。相對於 Kowa，Kowa 確實繼續朝著我所說的 PCP 銷售週期動態穩步前進。我們確實希望它們能對我們 2025 年的收入產生正面影響。但與所有新銷售團隊或新產品發布一樣，特別是在初級保健領域，需要與初級保健醫生進行高水準的接觸和頻繁的交流才能啟動產品的試用。因此，我們相信 Kowa 將繼續進步並產生這種影響。

But you think about within the primary care or ped market, there's been no promotion of non-steroidals. Kowa is the first to do it within these two market segments. And so it does take a little bit of extra time in that selling cycle to be able to educate not only the provider, but also to educate the staff relative to the process of fulfilling that prescription. But Kowa continues to engage there, create interest, and we are seeing positive signals as we move forward.

但想想看，在初級保健或兒科市場中，非類固醇藥物並沒有被推廣。Kowa 是第一家在這兩個細分市場中做到這一點的公司。因此，在銷售週期中確實需要花費一些額外的時間來不僅培訓供應商，還要培訓與履行處方流程相關的員工。但 Kowa 繼續參與其中，創造興趣，我們在前進的過程中看到了積極的信號。

Kambiz Yazdi, Jefferies.

坎比茲·亞茲迪（Kambiz Yazdi），傑富瑞（Jefferies）。

A few on my end. What are the next steps after litigation stay? Or you do a joint status update at some point? And then separately, maybe on ARQ-255, what are the key learnings from ARQ-252 and oral baricitinib? And then as a third and last question, kind of what's the white space in alopecia areata for a new topical treatment?

我這邊有幾個。訴訟中止後下一步該怎麼做？或者你們在某個時候進行聯合狀態更新？然後分別來說，也許就 ARQ-255 而言，從 ARQ-252 和口服巴瑞替尼中可以學到什麼關鍵知識？然後作為第三個也是最後一個問題，斑禿的空白處適合新的局部治療方法嗎？

Sure. Let me address the IP question, and then Patrick, maybe you can talk about 255 in alopecia areata. So with regard to the patent litigation, the stay is an indefinite stay. The reason that Padagis requested the stay is not something I could discuss. That's something that you would need to discuss with them.

當然。讓我來回答一下 IP 問題，然後帕特里克，也許你可以談談斑禿中的 255。因此，就專利訴訟而言，該中止是無限期的中止。我無法討論帕達吉斯請求暫緩執行的原因。這是你需要與他們討論的事情。

But I think that it is not unreasonable for one to conclude that they must have had some problem with their development or with the FDA. They filed in February of 2024 with the FDA, their ANDA. Under the GDUFA guidelines, which are the same as PDUFA, they should have received a conditional approval in November of 2024. To the best of our knowledge, they did not receive that. So I can't -- I don't know what the issue is, but clearly they've had some issue.

但我認為，人們得出這樣的結論並非不合理：他們的開發或 FDA 一定存在一些問題。他們於 2024 年 2 月向 FDA 提交了 ANDA。根據與 PDUFA 相同的 GDUFA 指南，他們應該在 2024 年 11 月獲得有條件批准。據我們所知，他們沒有收到該訊息。所以我不能——我不知道問題是什麼，但顯然他們遇到了一些問題。

The quarterly updates that we are to provide jointly to the court really are just to update the court on the status of the dispute, let's say, between the two companies. They are also required to share with us their FDA correspondence so that we can see if that program is moving forward and when. And at such a time as we feel that it's necessary to move forward with litigation again, we have that option. We also will benefit from the remainder of our 30-month Hatch-Waxman stay should the litigation restart.

我們每季向法院聯合提交的最新消息其實只是為了向法院通報糾紛的現狀，比如說兩家公司之間的糾紛。他們還必須與我們分享其與 FDA 的通信，以便我們了解該計劃是否正在推進以及何時推進。當我們覺得有必要再次提起訴訟時，我們有這個選擇。如果訴訟重新開始，我們也將受益於剩餘的 30 個月 Hatch-Waxman 中止期。

But honestly, I don't know whether the litigation will ever progress, whether their program will ever progress. You really have to talk about that with Padagis. And then Patrick, do you want to address the questions around 255 in alopecia areata?

但說實話，我不知道訴訟是否會取得進展，他們的計畫是否會取得進展。你確實必須與帕達吉斯討論這個問題。然後派崔克，你想解答有關斑禿 255 的問題嗎？

Yes, absolutely. So I think most importantly, it's important to note that ARQ-255 is a completely unrelated formulation to ARQ-252. So we had the challenge of being able to get sufficient drug with 252 into the skin. With 255, this is not a solution. The drug's not dissolved.

是的，絕對是。因此我認為最重要的是，需要注意的是 ARQ-255 與 ARQ-252 是完全不相關的公式。因此，我們面臨的挑戰是如何將足夠的 252 藥物注入皮膚。對於 255 來說，這不是一個解決方案。藥物尚未溶解。

It's actually a suspension of the JAK inhibitor. And it's designed to be able to deliver the drug down the hair follicle and to overcome, I would say, what has been the biggest challenge for any topical approach for alopecia areata, which is just the depth of the hair follicle, which is where the relevant inflammation is which is where the target is for this treatment. And so we took a unique approach with that. Now with regard to the oral, we know that the oral actually works in alopecia areata. It's a very potent JAK inhibitor.

它實際上是JAK抑制劑的懸浮液。它的設計目的是將藥物輸送到毛囊，並克服任何局部治療斑禿的最大挑戰，也就是毛囊的深度，也就是相關發炎所在的地方，也是這種治療的目標。因此我們採取了獨特的方法。現在關於口服，我們知道口服實際上對斑禿有效。它是一種非常有效的JAK抑制劑。

So that's important. And the key issue is just to overcome getting the drug to where it needs to go. With regard to the second part of your question and the white space in alopecia areata, we know that the oral systemic administration of JAK inhibitors for patients with extensive alopecia areata can be a treatment option, and many patients have benefited from that. I think the white space is really in several different places for that patient journey. One of them would be patients leading up to where they get to their 50% scalp involvement that would make them a candidate for systemic treatment.

這很重要。關鍵問題是如何將藥物運送到需要去的地方。關於您問題的第二部分以及斑禿的白斑問題，我們知道，對於大面積斑禿患者，口服JAK抑制劑系統性治療可以作為一種治療選擇，並且許多患者已經從中受益。我認為，在患者的旅程中，空白確實存在於幾個不同的地方。其中一種情況是，患者的頭皮受累面積達到 50%，因此適合接受全身性治療。

And many patients, even when they get there, aren't very keen on being long term on the JAK inhibitor and being -- because many of these patients are younger and may not be wanting to go on to a systemic immune suppressant for a long period of time. And then the other one is once a patient may have had a good benefit from being on a JAK inhibitor, what's the long-term potential for managing that patient? You would at some point want to think about withdrawing that immune suppression and seeing if the disease is resolved kind of while the patient was on treatment. That would be another opportunity for being able to have a topical option. So I think there are many different places where a topical would be appropriate for use even in an environment where we have systemic JAK inhibitors that work.

而且許多患者即使到達那裡，也不太熱衷於長期服用 JAK 抑制劑——因為這些患者中有許多比較年輕，可能不想長期服用全身免疫抑制劑。另一個問題是，一旦患者可能從使用 JAK 抑制劑中獲益，那麼治療該患者的長期潛力是什麼？在某些時候，您可能會考慮停止免疫抑制，並觀察患者在接受治療期間疾病是否已解決。這將是獲得主題選擇的另一個機會。因此我認為，即使在我們有全身性 JAK 抑制劑發揮作用的環境中，外用藥物也適用於許多不同的地方。

Serge Belanger, Needham.

塞爾日·貝朗格，尼德漢姆。

A couple for Frank and Todd. Going back to the 1Q performance, it looks like you were able to avoid the usual seasonality or not see the typical seasonality. Just curious if that was a function of strong growth that allowed you to avoid it, or there was something more specific in terms of a better reauthorization process that minimized the seasonality. And then secondly, I think on slide 10, you highlighted that 80% of ZORYVE franchise prescriptions are currently covered by insurance. Curious if we should expect some additional improvements on that number over time.

弗蘭克和托德的一對。回顧第一季的表現，看起來您能夠避免通常的季節性或看不到典型的季節性。只是好奇這是否是強勁增長的功能，可以讓你避免這種情況，或者在更好的重新授權流程方面有更具體的東西，可以最大限度地減少季節性。其次，我認為在第 10 張投影片上，您強調了 80% 的 ZORYVE 特許經營處方目前都由保險承保。好奇的是，隨著時間的推移，我們是否應該期待這個數字會有一些額外的改善。

Yes. Todd, do you want to take this?

是的。托德，你想接受這個嗎？

Yes. Relative to Q1, let me just take a step back, specifically. First, let me address the revenue, as mentioned in the opening comments. We did see some impact on our gross to net early in the quarter. And of course, that was due to the patients change in insurance as well as the deductible resets that typically occur during that time.

是的。相對於第一季度，具體來說，讓我回顧一下。首先，讓我談談開篇評論中提到的收入問題。我們確實看到本季初我們的毛利率對淨利率產生了一些影響。當然，這是由於患者的保險發生變化以及在此期間通常發生的免賠額重置。

But nonetheless, we were able to swiftly improve on our gross to net in Q1 to where we made sure that we stayed within the steady state of the 50%, which is very encouraging and will -- could be a positive signal as we roll forward into the year. Relative to demand, as mentioned earlier, we had 10% quarter-over-quarter growth, Q1 versus Q4. I think there's a direct correlation relative to the momentum that we have built with this franchise. When you think about ZORYVE's differentiation relative to other options within the market, being able to offer three unique ZORYVE products for three unique skin inflammatory diseases really makes ZORYVE a one-stop solution for both the provider and the patient, and I think that portfolio effect continues to resonate with both providers and patients. And we expect that only to be amplified once we get the foam scalp and body launch, and we'll continue that momentum as we roll through 2025.

但儘管如此，我們還是能夠在第一季迅速提高毛利率與淨利率的比率，確保保持在 50% 的穩定狀態，這是非常令人鼓舞的，並且可能對我們進入新的一年產生積極信號。相對於需求，如前所述，第一季與第四季相比，我們的環比成長了 10%。我認為這與我們透過該系列建立的勢頭有直接的關聯。當您考慮 ZORYVE 相對於市場上其他選擇的差異化時，能夠為三種獨特的皮膚發炎疾病提供三種獨特的 ZORYVE 產品確實使 ZORYVE 成為提供者和患者的一站式解決方案，我認為投資組合效應將繼續引起提供者和患者的共鳴。我們預計，一旦我們推出泡沫頭皮和身體產品，這一勢頭將會進一步增強，我們將在 2025 年繼續保持這一勢頭。

You want to address the coverage?

您想解決覆蓋範圍問題嗎？

Yes. Relative to the coverage rate, we mentioned that we're kind of in an optimal steady state relative to 80% covered or reimbursed prescriptions. We anticipate that we will stay -- relative to the improvement, we'll stay within that 80% range. We have very good coverage of ZORYVE across all three products now, which is leading to those reimbursed rates that we see, which I think was a contributor relative to maintaining a positive gross to net during Q1. So we expect minimal change, and we'll stay within that steady state of 80% covered reimbursed prescriptions.

是的。相對於覆蓋率，我們提到，相對於 80% 的覆蓋或報銷處方，我們處於最佳穩定狀態。我們預計，相對於改善，我們將保持在 80% 的範圍內。目前，我們對 ZORYVE 的所有三種產品的覆蓋率都非常好，這導致了我們看到的報銷率，我認為這是在第一季保持正毛利與淨利之比的一個因素。因此，我們預計變化很小，並且我們將保持在 80% 報銷處方的穩定狀態。

And let me just touch a little bit on the demand point, too. Again, I think some investors maybe aren't used to this dynamic. But Q4 is typically very strong as patients pull forward demand before the deductible resets. We certainly saw that if you look at slide 9 in our deck, there is a very clear demand spike in Q4.

我也來稍微談談需求點。再次，我認為一些投資者可能不習慣這種動態。但第四季通常非常強勁，因為患者在免賠額重置之前提前提出需求。我們當然看到，如果你看一下我們簡報中的第 9 張投影片，你會發現第四季的需求明顯激增。

And many brands experience actually a decline in demand then in Q1 because the patients aren't filling scripts in January that they filled in December. So the fact that we were able to grow quarter-over-quarter in spite of that demand pull forward, I think it's really pretty notable. And if you look at many of the other branded topicals, they have been largely flat in the quarter compared to Q4, whereas we've been able to deliver yet another strong quarter of demand growth in Q1. And I think that bodes well for us going forward as well.

許多品牌在第一季的需求實際上都出現了下降，因為患者在一月份開的處方數量不如在十二月份開的那麼多。因此，儘管需求提前，我們仍能達到環比成長，我認為這是非常值得注意的。如果你看一下其他品牌的外用藥，你會發現本季與第四季相比，它們基本上持平，而我們在第一季又實現了強勁的需求成長。我認為這對我們未來的發展也是個好兆頭。

And if I could mention one other dynamic. If you think about what Frank mentioned relative to the pull forward of the refills into December, when you look at that demand increase that we had in Q1, those are NBRxs. That means they're new-to-brand Rxs. And so we're driving new growth of new prescriptions in January, which is going to lead to incremental refills, say in Q2, Q3 and Q4 this year. So once again, a very positive signal relative to the health of the business.

如果我可以提及另一個動態。如果您想想弗蘭克提到的關於將補充量提前到 12 月的內容，當您看到我們在第一季的需求增長時，這些都是 NBRxs。這意味著它們是新品牌 Rxs。因此，我們將在一月推動新處方的成長，這將導致今年第二季、第三季和第四季的續藥量增加。因此，這再次表明，這對於企業的健康發展是一個非常積極的信號。

Douglas Tsao, H.C. Wainwright.

曹德華，H.C.溫賴特。

I'm just curious, as we look ahead to the approval for the foam into scalp and body psoriasis, I'm just curious because when we first saw the foam get approved to the market, we saw a very rapid adoption. We've obviously seen as you've added additional indications some incremental growth, but perhaps less dramatically. What is your expectation? And how should we think about the trajectory from the addition of that indication fairly soon?

我只是很好奇，當我們展望泡沫用於治療頭皮和身體牛皮癬的批准時，我很好奇，因為當我們第一次看到泡沫獲得市場批准時，我們看到了非常迅速的採用。隨著您添加額外的跡象，我們顯然看到了一些增量增長，但可能不那麼顯著。你的期望是什麼？我們應該如何考慮很快增加該指示後的軌跡？

Yes. So Douglas, that's really an important question. The launch of the foam in seborrheic dermatitis was a very, very unique unicorn kind of situation, one that I have never experienced in three decades in the business, and I don't think Todd has either. That was a disease that where there had been no innovation in over two decades. A very large population, very high level of dissatisfaction with existing therapies.

是的。所以道格拉斯，這確實是一個重要的問題。推出用於治療脂漏性皮膚炎的泡沫藥物是一種非常非常獨特的情況，是我在三十年從業生涯中從未經歷過的，我想托德也沒有經歷過。那是一種二十多年來沒有任何創新的疾病。人口數量非常龐大，對現有療法的不滿程度非常高。

And I can tell you from -- I know for a fact that I spoke with a number of clinicians early last year who had literally hundreds of patients lined up waiting to go on the foam. So the minute we got approved, there was a vertiginous uptake of the foam, the likes of which I have never seen before. And certainly, we actually honestly hadn't expected when we launched it, not that pace. I don't think that scalp is of that same degree of unmet need. There are options.

我可以告訴你們——我知道一個事實，去年年初我與一些臨床醫生交談過，他們有數百名患者排隊等待接受泡沫治療。因此，我們一獲得批准，泡沫就迅速膨脹起來，這是我以前從未見過的。當然，我們在推出它的時候確實沒有想到會有這樣的速度。我不認為頭皮有同樣程度的未滿足需求。有多種選擇。

You can use biologics, which some of them are very, very good. The scalp is one area that maybe doesn't respond as well, but it does respond. There are steroid options for use on the hair. So you don't have this complete absence of good options, I think, in scalp, although ZORYVE is a very, very competitive option. So I wouldn't expect to see that sort of almost vertical trajectory in scalp psoriasis.

您可以使用生物製劑，其中一些非常非常好。頭皮可能是反應不太好的部位之一，但它確實有反應。有可用於頭髮的類固醇選擇。因此，我認為，在頭皮方面，你並不完全沒有好的選擇，儘管 ZORYVE 是一個非常非常有競爭力的選擇。所以我不希望看到頭皮牛皮癬出現這種幾乎垂直的軌跡。

I think that there probably are some doctors who are using the foam already, although I don't think that's probably widespread because they need to code it as seb derm to get it reimbursed. So I think what we're likely to see is the scalp indication allowing us to continue our growth trajectory. If you go again back to Slide 9, how do we continue to grow that franchise at a fairly continuous rate? I think foam is going to be an important contributor to that as will be AD in 2 to 5s. But I wouldn't expect to see a sudden spike in our demand after the approval.

我認為可能有些醫生已經在使用這種泡沫了，儘管我認為這種泡沫可能還沒有普及，因為他們需要將其編碼為脂漏性皮膚炎才能獲得報銷。因此，我認為我們可能會看到的是頭皮跡象，讓我們能夠繼續我們的成長軌跡。如果您再次回到投影片 9，我們如何繼續以相當連續的速度發展該特許經營權？我認為泡沫將成為其中的重要貢獻者，就像 2 到 5 秒內的 AD 一樣。但我預計批准後我們的需求不會突然激增。

And if I can with just a follow-up. How much education and how much promotional sensitivity do you expect to see with the scalp and body indication with the foam?

如果可以的話我再跟進一下。您希望看到多少有關泡沫對頭皮和身體的教育和促銷敏感性？

Well, I mean, all of these diseases are highly promotionally sensitive. And I think that the scalp data, as Patrick showed you in the photographs and also the IGA success data, that the data is very, very compelling. So it will be important for our reps to get out and educate clinicians on the effectiveness of ZORYVE and the safety and tolerability of ZORYVE in scalp psoriasis, which there has not been any promotional educational efforts to date.

嗯，我的意思是，所有這些疾病都具有高度的宣傳敏感性。我認為頭皮數據（正如帕特里克在照片中向您展示的那樣）以及 IGA 成功數據非常非常引人注目。因此，我們的代表必須走出去，向臨床醫生宣傳 ZORYVE 的有效性以及 ZORYVE 在治療頭皮牛皮癬方面的安全性和耐受性，但迄今為止還沒有任何宣傳教育活動。

So I think that there will be some -- there will be incremental upside from the scalp indication as we get out and start promoting this data and also because it will help streamline the reimbursement process for using the foam in scalp psoriasis as well. Todd, I don't know if you have any other additional thoughts you want to add?

因此我認為，隨著我們開始推廣這些數據，頭皮適應症將帶來一些增量上行空間，同時也因為它將有助於簡化使用泡沫治療頭皮牛皮癬的報銷流程。托德，我不知道您是否還有其他想法要補充？

No, you covered it very well.

不，你講得很好。

This concludes today's question-and-answer session. I'll now hand back for closing remarks.

今天的問答環節到此結束。我現在將發言交回，以便發表結束語。

Well, I'll just once again thank everyone for calling in. I know this is a very, very busy time of the year with quarterly earnings, so we appreciate you guys making the time and appreciate all the great questions, and we look forward to talking to you all next quarter. Thanks.

好吧，我再次感謝大家的來電。我知道現在是一年中非常非常繁忙的季度收益期，所以我們感謝你們抽出時間並感謝你們提出的所有重要問題，我們期待著下個季度與你們交談。謝謝。

This concludes today's conference call. Thank you for participating. You may now disconnect.

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。