Arcutis Biotherapeutics Inc (ARQT) 2024 Q4 法說會逐字稿

Good day. And welcome to Arcutis Biotherapeutics 2024 fourth quarter and full-year financial results conference call. (Operator Instructions)

再會。歡迎參加 Arcutis Biotherapeutics 2024 年第四季和全年財務業績電話會議。（操作員指令）

Please be advised after today's conference is being recorded. I will hand the call over to Latha Vairavan, Vice President of Finance and Corporate Controller. Please go ahead.

今天的會議正在錄製中，敬請期待。我將把電話轉給財務副總裁兼公司財務長 Latha Vairavan。請繼續。

Thank you. Good afternoon, everyone. And thank you for joining us today to review our fourth quarter and full-year 2024 financial results and business update.

謝謝。大家下午好。感謝您今天加入我們，回顧我們的 2024 年第四季和全年財務表現和業務更新。

Slides for today's call are available on the investor 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 David Topper, Chief Financial Officer.

今天的電話會議幻燈片可以在 Arcutis 網站的投資者部分找到。今天參加電話會議的有總裁兼執行長 Frank Watanabe；伯內特 (Patrick Burnett)，首席醫療官；首席商務官 Todd Edwards；以及財務長 David Topper。

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 certainties. 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。這些聲明受一定的風險和確定性的影響。我們的實際結果可能會有所不同。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, Latha. And thank you to everyone for joining us today. Before we get started, I want to highlight three key themes that we're going to focus on throughout the call today. First of all, we had very strong execution throughout 2024.

謝謝你，拉莎。感謝大家今天的出席。在我們開始之前，我想強調一下我們今天在電話會議上要關注的三個關鍵主題。首先，我們在整個 2024 年的執行力非常強。

Second, we believe we are nicely set up to continue growing ZORYVE in 2025 and beyond. And third, the key to our success going forward is going to be driving the shift away from topical steroids.

其次，我們相信我們已經做好了在 2025 年及以後繼續發展 ZORYVE 的準備。第三，我們未來成功的關鍵是推動不再使用外用類固醇。

So with that, let me turn to slide 5 of the deck, closing out a very strong fourth quarter and full year for 2024, we are optimistic about the strong foundation we have established for the entire ZORYVE portfolio and for continued growth of our franchise this coming year and beyond.

因此，讓我轉到幻燈片的第 5 頁，結束了非常強勁的 2024 年第四季度和全年，我們對為整個 ZORYVE 產品組合建立的堅實基礎以及我們特許經營權在來年及以後的持續增長感到樂觀。

I want to take this moment to thank the entire Arcutis team for their hard work and exceptional execution in 2024. We are building a leading topical brand, one that we believe will outperform historical predicates based on its remarkable efficacy and safety, rapid onset, unique formulation, and the ease of use for both clinicians and patients.

我想藉此機會感謝整個 Arcutis 團隊在 2024 年的辛勤工作和出色表現。我們正在建立一個領先的主題品牌，我們相信，憑藉其卓越的功效和安全性、快速起效、獨特的配方以及對臨床醫生和患者的易用性，該品牌將超越歷史預期。

This past year, we launched ZORYVE foam for seborrheic dermatitis and ZORYVE foam 0.15% cream for atopic dermatitis and also broadened patient access across indications.

去年，我們推出了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 泡沫 0.15% 乳膏，並擴大了不同適應症患者的治療使用範圍。

In 2025, we'll further expand ZORYVE's approved indications, continue to expand our prescriber base beyond dermatology, further penetrate the government payer segment, and focus on taking market share from topical steroids.

2025 年，我們將進一步擴大 ZORYVE 的核准適應症，繼續擴大皮膚病學以外的處方藥基礎，進一步滲透政府付款人領域，並專注於搶佔外用類固醇的市場份額。

We're especially excited about our May 22 PDUFA date for an expected indication in scalp and body psoriasis, which will provide another opportunity for doctors to prescribe ZORYVE foam to meet a substantial unmet medical need.

我們對 5 月 22 日的 PDUFA 日期感到特別興奮，預計該藥物將用於治療頭皮和身體牛皮癬，這將為醫生提供另一個機會來開出 ZORYVE 泡沫來滿足大量未滿足的醫療需求。

We continued our strong sequential revenue growth. For the quarter, we had revenues of $71 million with $69 million of that coming from the ZORYVE franchise. This includes a non-recurring adjustment of $4 million that David will address in detail later.

我們的收入持續保持強勁成長。本季度，我們的營收為 7,100 萬美元，其中 6,900 萬美元來自 ZORYVE 特許經營權。其中包括 400 萬美元的非經常性調整，David 稍後將詳細介紹。

On an annual basis, we had total revenues of $197 million with three product sales of $167 million, 471% growth year over year. And we are just scratching the surface of this very large and attractive market.

從年度來看，我們的總收入為 1.97 億美元，其中三種產品的銷售額為 1.67 億美元，年增 471％。而我們僅僅觸及了這個非常龐大且具吸引力的市場的表面。

We expect substantial continued momentum in 2025. And Todd will provide further detail on how we view revenue and script growth trends evolving throughout 2025.

我們預計 2025 年將持續保持強勁發展勢頭。托德將進一步詳細說明我們如何看待 2025 年的收入和劇本成長趨勢。

Blended gross to net has reached steady state in the 50s, although we expect to see some quarterly fluctuations related to patient deductibles, particularly in the first quarter, as is typical for nearly every product.

混合毛利與淨利已達到 50 左右的穩定狀態，儘管我們預計與患者免賠額相關的季度波動會加劇，尤其是在第一季度，這幾乎是每種產品的典型特徵。

Regardless, we expect gross to net to remain in the 50s. And Todd will provide some additional color on what we expect for gross to net as the brand matures.

無論如何，我們預計毛利與淨利比率將保持在 50 左右。隨著品牌的成熟，Todd 還將對我們預期的毛利潤與淨利潤進行一些額外的說明。

Looking towards 2025, we believe we are well positioned to achieve future -- further strong growth revenue -- strong revenue growth. Our psoriasis and Seb Derm indications continue to grow. We're still very much in new launch mode for atopic dermatitis. And we expect to add further indications and label expansions in the coming year, providing us with significant growth opportunities ahead.

展望 2025 年，我們相信我們已準備好實現未來進一步強勁的營收成長。我們的牛皮癬和脂漏性皮症適應症持續成長。我們對於異位性皮膚炎的治療仍處於全新的研發階段。我們預計在來年將增加更多適應症和標籤擴展，這將為我們提供未來巨大的成長機會。

Turning to slide 6, I want to emphasize the sizable growth opportunity we have in our target markets. We've shared this slide with you before. But we've now updated the slide to include the opportunity in 80 patients, ages two to five, based on our supplemental NDA with an anticipated PDUFA sometime in Q4 of 2025.

轉到第 6 張投影片，我想強調我們在目標市場中擁有的巨大成長機會。我們之前曾與你們分享過這張幻燈片。但現在我們已經更新了幻燈片，根據我們的補充 NDA 以及預計在 2025 年第四季度的某個時候簽訂的 PDUFA，將這一機會納入 80 名 2 至 5 歲患者中。

Dermatologists treat well over 8 million patients across our approved indications. And we've already secured broad access to the roughly 4.5 million commercially insured patients treated by derms.

皮膚科醫師已治療了我們核准適應症範圍內超過 800 萬名患者。而且我們已經確保了大約 450 萬名接受皮膚科治療的商業保險患者的廣泛使用。

We're now making great progress in gaining Medicare and Medicaid coverage, which is expanding ZORYVE usage into the almost 4 million dermatologists-treated patients with government insurance.

我們在獲得醫療保險和醫療補助覆蓋方面取得了巨大進展，這將使 ZORYVE 的使用範圍擴大到近 400 萬名接受政府保險的皮膚科醫生治療的患者。

Furthermore, our Kowa commercial partnership permits us to simultaneously pursue the more than 8.5 million patients being treated outside of the dermatology office for these indications. This includes primary-care physicians and pediatricians for whom ZORYVE represents an ideal, easy-to-use topical, anti-inflammatory agent.

此外，我們與 Kowa 的商業合作關係使我們能夠同時為 850 多萬名在皮膚科診所外接受這些適應症治療的患者提供服務。其中包括初級保健醫生和兒科醫生，對他們來說，ZORYVE 是一種理想的、易於使用的外用抗發炎藥物。

Within each of these large segments outlined on the slide, the vast majority of patients are currently treated with topical steroids. But clinicians are starting to shift away from these products, although we're only in the very early stages of this transition in medical practice. And Patrick's going to talk more about the shift away from steroids in just a few minutes.

在投影片上勾勒出的每個大片段中，絕大多數患者目前都接受局部類固醇治療。但儘管我們才處於醫療實踐轉變的早期階段，臨床醫生已經開始不再使用這些產品。帕特里克將在幾分鐘後進一步談論擺脫類固醇的話題。

Moving to slide 7, we are confident in our ability to sustain our growth because of four significant tailwinds that are going to propel ZORYVE forward in the years to come. Let's dig into those tailwinds a little bit further.

第 7 頁，我們對維持成長的能力充滿信心，因為四個重要的順風將在未來幾年推動 ZORYVE 向前發展。讓我們進一步深入探討這些順風。

First, we continue to educate physicians on our three approved indications while continuing to expand the ZORYVE product label. As mentioned, we have an expected approval in scalp-and-body psoriasis in May, as well as an anticipated expanded indications for pediatric patients in both atopic dermatitis and eventually, psoriasis.

首先，我們繼續向醫生介紹我們批准的三種適應症，同時繼續擴大 ZORYVE 產品標籤。如上所述，我們預計該藥物在五月獲得頭皮和身體牛皮癬治療領域的批准，並且預計其適應症將擴大到兒童異位性皮膚炎和牛皮癬患者。

These expanded pediatric indications are especially important for our commercial partner, Kowa and reinforce ZORYVE as a first-line topical agent to a broad prescriber base that now encompasses primary care physicians and pediatricians.

這些擴大的兒科適應症對我們的商業夥伴 Kowa 來說尤其重要，並強化了 ZORYVE 作為廣泛處方人群的一線外用藥物的地位，目前該人群包括初級保健醫生和兒科醫生。

Second, with our commercial coverage established, we are now engaging with government payers across both Medicare and Medicaid, which encompass approximately 3.7 million incremental patients in dermatology offices, and many more in primary care and pediatrics.

其次，隨著我們商業覆蓋範圍的建立，我們現在正在與醫療保險和醫療補助的政府付款人合作，這涵蓋了皮膚科診所約 370 萬新增患者，以及初級保健和兒科的更多患者。

We have been rapidly gaining winds in Medicaid with ZORYVE already available for 1 in 2 Medicaid patients. And Todd will provide some more color on that front.

我們在醫療補助方面進展迅速，每 2 名醫療補助患者中就有 1 名可以使用 ZORYVE。托德將在這方面提供更多細節。

Third, our partners at Kowa, are now promoting ZORYVE to high-potential primary care doctors and pediatricians. And we expect them to gain growing traction as 2025 progresses. We look forward to meaningful contribution from this co-promote beginning this year and growing from there.

第三，我們在 Kowa 的合作夥伴現在正在向具有高潛力的初級保健醫生和兒科醫生推廣 ZORYVE。我們預計，隨著 2025 年的到來，它們將獲得越來越大的吸引力。我們期待此次聯合推廣從今年開始就能夠做出有意義的貢獻並不斷成長。

And finally, with our broad product offerings, comprehensive patient access, and differentiated product profile for both doctors and patients, Arcutis is now well positioned to take meaningful market share from the16 million topical steroid prescriptions written by dermatologists for our approved indication each year. There has been growing momentum in that direction. And Todd and Patrick will delve into this further.

最後，憑藉我們廣泛的產品系列、全面的患者訪問管道以及針對醫生和患者的差異化產品組合，Arcutis 現已準備好從皮膚科醫生每年為我們批准的適應症開出的 1600 萬張外用類固醇處方中奪取有意義的市場份額。這方面的勢頭日益增強。托德和派崔克將進一步深入探討這個問題。

Taken together this immense market size, coupled with the excellent efficacy and safety of ZORYVE and its ease of use and access, make us highly optimistic regarding our future prospects and committed to grow ZORYVE to its peak-sales potential.

綜合考慮這一巨大的市場規模，再加上 ZORYVE 出色的功效和安全性以及其易於使用和獲取的特點，讓我們對未來前景充滿信心，並致力於將 ZORYVE 發展到其高峰銷售潛力。

With that, let me turn it over to Todd to provide some further commentary around our launch progress, reimbursement, and the outlook for 2025.

接下來，讓我將主題交給 Todd，讓他就我們的發布進度、報銷以及 2025 年的前景提供進一步的評論。

Thank you, Frank. We're extremely enthusiastic about the growth from the expansion of our product portfolio, the strong response from HCPs and patients, and the immense opportunities that lie ahead.

謝謝你，弗蘭克。我們對產品組合的擴大、HCP 和患者的強烈反應以及未來的巨大機會所帶來的成長感到非常興奮。

This quarter, we achieved $69.4 million, $65.4 million before the non-recurring adjustment in net product revenue for ZORYVE, reflecting 46% growth over the third quarter.

本季度，ZORYVE 的淨產品收入實現 6,940 萬美元，扣除非經常性調整前為 6,540 萬美元，較第三季增長 46%。

Without our non-recurring adjustment for product return reserves and $166.5 million in net product revenue for the full year, a growth of 471% over last year. The strong performance continued the robust quarter-over-quarter growth trend that we have seen throughout the year.

除去我們對產品退貨準備金的非經常性調整，全年淨產品收入1.665億美元，較去年同期成長471%。強勁的表現延續了我們全年看到的強勁的季度成長趨勢。

This robust revenue growth was driven primarily by prescription growth across the portfolio of ZORYVE products, along with a slight gross-to-net percentage improvement with the blended gross to net remaining in the low 50s for Q4.

強勁的營收成長主要得益於 ZORYVE 產品組合的處方成長，以及毛利與淨利百分比的略有改善，第四季混合毛利與淨利百分比仍維持在 50% 以下。

Looking forward to 2025 in the first quarter, we expect the typical gross-to-net impact, driven by deductible resets and insurance plan changes for the new year. As we know well, this phenomenon negatively impacts sales of many products across the pharmaceutical space. But as is typical, we expect gross to net to quickly trim back the steady state in subsequent quarters.

展望 2025 年第一季度，我們預期新年免賠額重置和保險計畫變更將帶來典型的總保額對淨保額的影響。眾所周知，這種現象對醫藥產業許多產品的銷售產生了負面影響。但正如通常情況一樣，我們預計毛利率與淨利率將在隨後的幾季迅速降至穩定狀態。

Turning to volume, we anticipate sustained growth and are encouraged by the trends, so far, this year. It is common to see a decline in prescription volume growth for products in January, following the end of year demand pull forward. And we are seeing such a decline for many of the other branded topical non-steroidals.

談到銷量，我們預計會持續成長，並對今年迄今為止的趨勢感到鼓舞。隨著年底需求的提前，1 月產品處方量增加是很常見的。我們也看到許多其他品牌外用非類固醇藥物的銷售量也出現了類似的下降。

While the typical Q1 gross-to-net fluctuation will affect total net product revenue, we're encouraged that we've been able to sustain and even expand the number of scripts written to date in 2025 compared to Q4 '24.

雖然第一季的典型總收入與淨收入波動將影響總淨產品收入，但我們很高興看到，與 2024 年第四季相比，我們能夠維持甚至擴大 2025 年迄今編寫的腳本數量。

Speaking of Q4 prescription volume, on slide 10, you can see that ZORYVE prescription volume has reached another record high at 16,000 weekly scripts. Quarter-over-quarter prescription growth was 44% over Q3. And prescriptions grew 334% on a year-over-year basis.

說到第四季的處方量，在投影片 10 上，您可以看到 ZORYVE 的處方量再創歷史新高，達到每週 16,000 份處方。與第三季相比，處方量較上季增加了 44%。處方量年增334%。

You can clearly see the inflections and growth during 2024 due to the launches of the ZORYVE foam and Seb Derm and 0.15% cream for atopic dermatitis.

隨著 ZORYVE 泡沫和 Seb Derm 以及 0.15% 異位性皮膚炎乳膏的推出，您可以清楚地看到 2024 年的變化和增長。

However, in Q4, I want to emphasize that we deliver growth across our entire product portfolio. Every indication has grown. And we expect this key trend to persist as we continue to take share from the enormous topical steroid market. I will delve into the drivers of this phenomenal growth next.

然而，在第四季度，我想強調的是，我們整個產品組合都實現了成長。各項跡象均有所增長。我們預計，隨著我們繼續從龐大的外用類固醇市場中搶佔份額，這一關鍵趨勢將持續下去。接下來我將深入探討這驚人成長的驅動因素。

On slide 11, I want to discuss the factors that led to the exceptional growth we achieved in Q4 and that we expect to continued growth and success in 2025. The first of these is our atopic dermatitis launch, which is still generating an inflection in prescriptions as you saw on the prior slide.

在第 11 張投影片上，我想討論一下導致我們在第四季度實現卓越成長的因素，以及我們預計在 2025 年將繼續實現成長和成功。其中第一個是我們的異位性皮膚炎產品的推出，正如您在上一張幻燈片中看到的那樣，它仍然在處方中產生變化。

Quite simply, physicians are recognizing that our once daily, non-steroidal anti-inflammatory can be used safely and effectively anywhere on the body affected by ectopic dermatitis for any duration and are appreciating the ease of reimbursement and prescription fulfillment established by our team.

很簡單，醫生們認識到我們每天一次的非類固醇抗發炎藥物可以在任何時間安全有效地用於受異位性皮膚炎影響的身體任何部位，並讚賞我們團隊建立的報銷和處方履行的便利。

The second growth factor is our salesforce expansion that occurred in late June, which has significantly enhanced our shared voice across Durham clinicians. With the multiple indications and formulations, we have created a unique portfolio versatility effect, which allows dermatologists multiple approaches to treating complex skin conditions using one or more ZORYVE products.

第二個成長因素是我們六月底發生的銷售團隊擴張，這大大增強了我們在達勒姆臨床醫師中的共同聲音。透過多種適應症和配方，我們創造了獨特的產品組合多功能效果，使皮膚科醫生可以使用一種或多種 ZORYVE 產品以多種方式治療複雜的皮膚病。

This is the third growth growth driver and creates an amplification effect upon each of the individual strengths of the cream as well as the foam formulation. By this, I mean that doctors now have a spectrum of options with respect to which ZORYVE's strength and formulation is tailored to each specific indication.

這是第三個成長動力，對乳霜的各個強度以及泡沫配方產生了放大效應。我的意思是，醫生現在擁有一系列的選擇，ZORYVE 的強度和配方可以根據每種特定的適應症進行量身定制。

This optionality and flexibility drive an overall increase in the use of the entire ZORYVE portfolio, which is rapidly becoming the go-to solution for dermatologists.

這種可選性和靈活性推動了整個 ZORYVE 產品組合的使用率的全面提升，該產品組合正迅速成為皮膚科醫生的首選解決方案。

We expect this to be a sustainable advantage into 2025 and beyond and should be further amplified by the addition of a new foam indication for body-and-scalp psoriasis in the second half of 2025 and the subsequent pediatric label expansion.

我們預計這將成為 2025 年及以後的可持續優勢，隨著 2025 年下半年增加針對身體和頭皮牛皮癬的新泡沫適應症以及隨後的兒科標籤擴展，這一優勢將進一步擴大。

Lastly, I want to highlight the strong execution of our entire commercial organization, which has been steadily picking up commercial and government coverage, delivering effective and targeted messages, and beginning our drive to convert over a meaningful percentage of the topical steroid market.

最後，我想強調我們整個商業組織的強大執行力，該組織一直在穩步提升商業和政府報道，傳遞有效和有針對性的信息，並開始努力轉化相當大比例的局部類固醇市場。

Slide 12 is an important slide where I want to make two key points. One is that our commercial coverage is quite good. And overall portfolio grows to net, as we said last quarter, has reached steady state. We expect the portfolio grows to net to be in the 50s throughout 2025.

投影片 12 是一張重要的投影片，我想在其中強調兩點。一是我們的商業覆蓋率比較好。正如我們上個季度所說，整體投資組合淨成長已達到穩定狀態。我們預計，2025 年投資組合的淨成長率將達到 50%。

First, to the left, you can see we have a strong position with prescriptions covered by insurance. We are at a steady state and an optimal point for psoriasis and Seb Derm 80%. And we are continuing to improve cover prescriptions for atopic dermatitis, currently at 65%.

首先，在左邊，您可以看到我們在保險覆蓋的處方方面佔有強勢地位。我們目前處於穩定狀態，且牛皮癬和脂漏性皮膚炎的治療效果達到 80% 的最佳點。我們正在繼續提高異位性皮膚炎的覆蓋處方，目前已達到 65%。

I'm delighted to report that since our last update, we have secured Medicaid coverage in two additional states, Ohio and Illinois. We have now secured Medicaid coverage in states that represent approximately 1 in 2 Medicaid beneficiaries. And we expect to add further states through 2025.

我很高興地報告，自上次更新以來，我們已在另外兩個州（俄亥俄州和伊利諾伊州）獲得了醫療補助。現在，我們已經在大約一半的醫療補助受益人所在的州獲得了醫療補助覆蓋。我們預計到 2025 年將增加更多州。

Importantly, the quality of Medicaid coverage is very strong. We're also making progress in our negotiations with Medicare Part D programs.

重要的是，醫療補助的覆蓋品質非常好。我們與聯邦醫療保險 D 部分計劃的談判也取得了進展。

Now moving to gross to net. In the chart on the right, we highlight the progressive improvements in our blended gross to net over time.

現在從毛額轉為淨額。在右側的圖表中，我們重點介紹了混合毛利與淨利隨時間推移的逐步改善。

Our [landic] gross to net across all three indications in Q4 was similar to Q3 in the low 50s. Our gross to net has reached a steady state and will be in the 50s throughout 2025.

我們第四季所有三個指標的毛利與淨利與第三季相似，都在 50 以下。我們的毛利與淨利潤之比已達到穩定狀態，到 2025 年將維持在 50% 左右。

As Frank stated earlier, we do expect some variability in the first quarter due to a reset of patient deductibles and changes of insurance plans, which both occur early during each year across all covered drugs. As we have reiterated, we expect that Q1 gross to net will be at the higher end of the 50s range but will quickly return to steady state and remain in the 50s throughout the year.

正如弗蘭克之前所說，我們確實預計第一季會出現一些變化，因為患者免賠額的重新設定和保險計劃的變化，這兩項變化每年年初都會發生在所有承保藥品中。正如我們曾經重申的那樣，我們預計第一季的毛利率與淨利率比率將處於 50% 左右的高端，但很快就會恢復穩定狀態，並全年保持在 50% 左右。

I am extremely excited to share some market research data with you on slide 13. We recently conducted research to assess unaided awareness of ZORYVE, as well as the most effective ZORYVE messages that doctors are hearing and remembering.

我非常高興在第 13 張投影片上與大家分享一些市場研究數據。我們最近進行了研究，以評估對 ZORYVE 的無輔助認知度，以及醫生聽到和記住的最有效的 ZORYVE 資訊。

We were extremely pleased both with the overall brand awareness of ZORYVE, as well as with the magnitude of improvement we have achieved over time. In psoriasis, unaided awareness grew from 55% in the second quarter to 63% in the fourth quarter.

我們對 ZORYVE 的整體品牌知名度以及我們隨著時間的推移所取得的進步幅度感到非常滿意。對於牛皮癬，無輔助認知度從第二季的 55% 成長到第四季的 63%。

Our foam formulation used in Seb Derm is even more widely recognized and unaided awareness, grew from 75% in Q2 to 88% in Q4. This means that just about every dermatologist is aware of ZORYVE and can rapidly recall it when prescribing to an appropriate patient.

我們在Seb Derm中使用的泡沫配方得到了更廣泛的認可和無人知曉，從第二季度的75％增長到第四季度的88％。這意味著幾乎每個皮膚科醫生都知道 ZORYVE，並且可以在給合適的患者開處方時快速記住它。

For the atopic dermatitis, 0.5 -- 0.15% is cream formulation, which launched in mid 2024, unaided awareness grew from 2% in Q2 to 44% in Q4. This is an impressive gain since we are still early in the launch.

對於異位性皮膚炎，0.5 – 0.15% 是乳膏配方，於 2024 年中期推出，獨立認知度從第二季的 2% 成長到第四季的 44%。由於我們仍處於發布初期，因此這是一個令人印象深刻的進步。

Tolerability and ease of use are really the standout messages for ZORYVE. Doctors remember that we are the only topical, non-steroidal agent, approved across three inflammatory skin indications. Additionally, the most motivating message for dermatologists focuses on ZORYVE's ease of use, which we view as a clear differentiator for our products.

耐受性和易用性確實是 ZORYVE 的突出特徵。醫生記得，我們​​是唯一獲得核准用於治療三種發炎皮膚病的外用非類固醇藥物。此外，對皮膚科醫生來說，最激勵人心的信息集中在 ZORYVE 的易用性上，我們認為這是我們產品的明顯差異化因素。

Earlier this month, we were delighted to announce a partnership with Odell Beckman Jr. or OBJ, an iconic professional football player who was affected by seborrheic dermatitis and who is a current ZORYVE foam user.

本月初，我們很高興宣布與 Odell Beckman Jr. 或 OBJ 建立合作夥伴關係，他是一位標誌性的職業足球員，患有脂漏性皮膚炎，目前是 ZORYVE 泡沫的用戶。

In the past 20 years, patients with Seb Derm had no innovation available to them. As a result, many retreated from care, resigning themselves to their condition. They were frustrated that nothing was available to help them. They lived with the embarrassing, itchy, flakey redness on their scalp, face, and body, and had to endure repeated shampoos and steroids, causing more frustration.

在過去的 20 年裡，脂漏性皮膚炎患者一直沒有得到任何創新治療。結果，許多人放棄了治療，接受了自己的狀況。由於沒有任何東西可以幫助他們，他們感到沮喪。她們忍受著頭皮、臉部和身體上令人尷尬的搔癢、片狀紅斑，還得忍受反覆洗髮和使用類固醇，這給她們帶來了更多的煩惱。

We believe that increasing patient awareness of Seb Derm and destigmatizing the disease will prompt a return to treatment for many of these patients. This important next step in the ZORYVE foam promotion strategy aligns well with the high level of unaided awareness for ZORYVE and positive clinical experience for the dermatologist, as well as the strong coverage position.

我們相信，提高患者對脂漏性皮膚炎的認識並消除對該疾病的恥辱感將促使許多患者重返治療。ZORYVE 泡沫推廣策略的這一重要下一步與 ZORYVE 的高無輔助知名度、皮膚科醫生的積極臨床體驗以及強大的覆蓋範圍相一致。

OBJ will be key in the coming year to executing our ZORYVE foam patient awareness initiatives. OBJ's personal story of struggling with Seb Derm, his symptoms, and all the treatments he tried will resonate with these patients. And as a ZORYVE foam patient himself, he will share the meaningful difference using ZORYVE foam has made on his life.

OBJ 將在來年執行我們的 ZORYVE 泡沫患者意識計劃的關鍵。OBJ 與脂漏性皮膚炎鬥爭的個人故事、他的症狀以及他嘗試過的所有治療方法都會引起這些患者的共鳴。作為 ZORYVE 泡沫患者，他將分享使用 ZORYVE 泡沫為他的生活帶來的有意義的變化。

We are ecstatic at the early reception from this new partnership. Not only does OBJ have a massive social media following of more than 17 million followers, but in the first week alone, interviews with him in mass media outlets like People, Prevention, Cosmopolitan, and Forbes have generated well over 1.5 billion media impressions.

我們對這項新合作關係的早期進展感到非常高興。OBJ 不僅在社交媒體上擁有超過 1700 萬粉絲，而且僅在第一周，《人物》、《預防》、《時尚》和《福布斯》等大眾媒體對他的採訪就產生了超過 15 億的媒體曝光量。

I would be remiss if I didn't also point out that at this time, we do not anticipate launching broadcast TV DTC advertisements as part of the OBJ partnership. Rather, we will rely on his celebrity reach, social media presence, digital advertising, and publicity to generate public awareness.

如果我不指出這一點，那我就是失職了，目前，我們並不打算在 OBJ 合作中推出廣播電視 DTC 廣告。相反，我們將依靠他的名人影響力、社交媒體影響力、數位廣告和宣傳來提高公眾知名度。

Thus, while there is some incremental SG&A spending associated with this partnership, we're talking low double-digit millions, not tens or hundreds of millions in incremental spend.

因此，雖然與此合作相關的銷售、一般及行政管理費用（SG&A）支出有一些增加，但我們談論的是低兩位數的數百萬美元，而不是數千萬或數億美元的增量支出。

On slide 15, I want to reiterate the majority of prescriptions across all three ZORYVE indications are for topical steroids. Of the 24 million topical prescriptions written by dermatology clinicians, there are three current indications during 2024, roughly 16 million were for topical steroids.

在第 15 張投影片上，我想重申 ZORYVE 三種適應症中的大多數處方都是局部類固醇。在皮膚科臨床醫師開立的 2,400 萬張外用藥物處方中，到 2024 年目前有三種適應症，其中約 1,600 萬張為外用類固醇。

When in contrast, 1.4 million prescriptions were for branded topical non-steroidals and around half a million were for ZORYVE, highlighting the immense growth opportunity as clinicians transition away from steroids to newer topical agents, which we will expect them to do as Patrick will discuss shortly.

相較之下，有 140 萬張處方是針對品牌外用非類固醇藥物，約有 50 萬張處方是針對 ZORYVE，這凸顯了隨著臨床醫生從類固醇轉向較新的外用藥物而出現的巨大增長機會，我們預計他們會這樣做，Patrick 很快就會討論這一點。

Our greatest opportunity is steroid conversions to ZORYVE for any of the entire brand of a topical marketplace. As we are already the leading brand of topical in inner [access], we believe that by focusing our energy on steroid conversion, we can impact more patients and continue to grow ZORYVE.

我們最大的機會是將類固醇轉化為 ZORYVE，用於任何外用藥物市場的整個品牌。由於我們已經是內服外用藥的領導品牌，我們相信，透過將精力集中在類固醇轉化上，我們可以影響更多的患者並繼續發展 ZORYVE。

Slide 16 highlights the strength of the ZORYVE, differentiated offering which encompasses three formulations of ZORYVE and expect the fourth indication of scalp-and-body psoriasis with the PDUFA upcoming in May 2025.

幻燈片 16 重點介紹了 ZORYVE 的優勢，其差異化產品涵蓋 ZORYVE 的三種配方，預計第四種適應症為頭皮和身體牛皮癬，PDUFA 將於 2025 年 5 月推出。

ZORYVE's differentiation is rapid relief on any part of the body for any duration, high tolerability, and quick onset of itch relief. Additionally, it is a simple-to-use, once daily treatment and it is easily accessible to patients with the same predictable reimbursement process and co-pay card across our entire portfolio. With that, I would now like to turn it over to Patrick to provide a brief R&D update. Patrick?

ZORYVE 的特色在於能夠在任意時間範圍內快速緩解身體任何部位的瘙癢，耐受性高，並且能快速緩解瘙癢。此外，它是一種易於使用、每日一次的治療方法，患者可以透過我們整個產品組合中相同的可預測的報銷流程和共同支付卡輕鬆獲得它。現在，我想讓派崔克簡要介紹研發進度。派崔克？

After a strong series of accomplishments in 2024. First, we have an upcoming FDA PDUFA action date for ZORYVE foam and scalp-and-body psoriasis, down to the age of 12 on May 22, 2025, and all aspects of the submission remain on track.

在 2024 年取得一系列強勁成就之後。首先，我們即將為 ZORYVE 泡沫和頭皮及身體牛皮癬制定 FDA PDUFA 行動日期，即 2025 年 5 月 22 日，即 12 歲以下，並且提交的所有方面仍在按計劃進行。

Second, we have an anticipated approval in Q4 2025 for ZORYVE cream 0.05%. It's a dose specifically developed for the treatment of mild to moderate AD in two- to five-year-olds. We expect to initiate an additional trial of ZORYVE cream at the 0.05% dose in mild to moderate AD patients ages 3 to 24 months during 2025.

其次，我們預計 0.05% ZORYVE 乳膏將於 2025 年第四季獲得批准。這是專門為治療兩至五歲兒童輕度至中度 AD 而研製的劑量。我們預計將於 2025 年對 3 至 24 個月大的輕度至中度 AD 患者啟動 0.05% 劑量 ZORYVE 乳膏的額外試驗。

Moreover, we continue to generate the necessary additional data that should ultimately support expanding the psoriasis syndication, down to the age of two. In our early-stage pipeline, we look forward to the phase 1B readout for ARQ-255, our topical jack and alopecia areata in the first half of 2025.

此外，我們將繼續產生必要的附加數據，這些數據最終將支持將牛皮癬聯合研究擴大到兩歲。在我們的早期研發管線中，我們期待在 2025 年上半年獲得 ARQ-255、我們的外用傑克和斑禿藥物的 1B 期讀數。

We expect to file the IND for ARQ-234, our biologic CD-200 receptor agonist for atopic dermatitis later in 2025. However, we do acknowledge that [Lilly] has deprioritized their CD-200R program and will continue to evaluate our own asset as we progress this program.

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 CD-200 受體激動劑 ARQ-234 的 IND。然而，我們確實承認 [禮來] 已經降低了他們的 CD-200R 計劃的優先級，並將在推進該計劃的同時繼續評估我們自己的資產。

Now on slide 19, we can see that the dermatology community is coalescing around increased awareness of the challenges of managing patients with chronic inflammatory skin diseases like psoriasis, AD, and seborrheic dermatitis with topical steroids.

現在在投影片 19 上，我們可以看到皮膚病學界正在團結起來，提高對使用外用類固醇治療牛皮癬、AD 和脂漏性皮膚炎等慢性發炎性皮膚病患者的挑戰的認識。

These include local tolerability issues, safety concerns, and limitations on duration of dosing for more potent steroids. This view is being expressed more and more frequently, both in published literature and at important medical conferences attended by dermatologists as evidence against steroid overutilization miles.

這些問題包括局部耐受性問題、安全性問題以及更有效的類固醇的給藥時間限制。這種觀點在出版的文獻中和皮膚科醫生參加的重要醫學會議上越來越多地被表達，作為反對過度使用類固醇的證據。

For example, the Journal of Clinical Aesthetic Dermatology, NPPA journal, recently ran a lengthy article, reviewing the concerns of managing inflammatory skin diseases with topical steroids and recommending clinicians move toward greater use of non-steroidal agents like ZORYVE.

例如，《臨床美容皮膚病學雜誌》（NPPA 雜誌）最近發表了一篇長篇文章，回顧了使用外用類固醇治療發炎性皮膚病的問題，並建議臨床醫生更多地使用非類固醇藥物，如 ZORYVE。

We're also now in the busiest season for DERMIS with several major meetings just wrapping up and the AAD a week away. So I want to share some of what we're hearing.

我們現在也處於 DERMIS 最繁忙的季節，幾個重要會議剛剛結束，而 AAD 會議還有一周就要舉行了。所以我想分享一些我們聽到的消息。

Indicative of this evolution in the thinking are statements such as those two that we've included at the bottom of slide 19, reflecting the stance from the podium at Maui Durham, about topical steroids going away as a mainstay of AD, as well as a response from a Durham provider after a recent presentation on steroid overuse and its impact on her practice and her communication with patients.

這種思維演變的標誌是我們在幻燈片 19 底部所列的兩條陳述，它們反映了毛伊達勒姆中心的立場，即外用類固醇將不再是 AD 的主要治療手段，同時也反映了達勒姆中心一位醫療服務提供者在最近一次關於類固醇過量使用及其對她的實踐和與患者溝通的影響的演講後的回應。

I've been in dermatology for over 20 years, and this is not a conversation that I've heard before. It is reminiscent of what took place when biologics came on the scene and old-school immunosuppressors were set aside in the long-term management of psoriasis and AD.

我從事皮膚科工作超過 20 年，我從未聽過這樣的對話。這讓人想起生物製劑出現後的情況，老式免疫抑制劑在牛皮癬和阿茲海默症的長期治療中被擱置一旁。

Now importantly, the profile of ZORYVE is perfectly positioned to step into this space this opening. In our clinical trials, we studied patients who previously used topical steroids and were able to demonstrate that ZORYVE is well positioned both as first-line treatment, as well as for those patients who've already tried and failed topical steroids.

現在重要的是，ZORYVE 的形象完美地定位於進入這個領域的空間。在我們的臨床試驗中，我們研究了先前使用過局部類固醇的患者，並能夠證明 ZORYVE 既可以作為第一線治療，也可以適用於那些已經嘗試過但失敗的局部類固醇患者。

Now, we did this across all of our development programs. So taking AD as an example and looking at the right side of slide 19. In our integument studies, we showed that ZORYVE cream 0.15%, has excellent clinical improvement for atopic dermatitis patients, even in those who have previously failed topical steroids.

現在，我們在所有開發專案中都做到了這一點。以 AD 為例，請查看投影片 19 的右側。在我們的外皮研究中，我們發現 0.15% ZORYVE 乳膏對異位性皮膚炎患者有極佳的臨床改善作用，即使對於先前使用外用類固醇失敗的患者也是如此。

We believe that data like this, combined with the changing consensus on steroid use, should drive a prolonged shift away from steroids that will benefit patients and our brand. With that, I'll pass it over to David.

我們相信，這樣的數據，加上對類固醇使用不斷變化的共識，應該會推動人們長期擺脫類固醇，這將有利於患者和我們的品牌。說完這些，我會把它交給大衛。

Thanks, Patrick. I'm on slide 21, showing financial results both year over year and quarter over quarter for the fourth quarter.

謝謝，派崔克。我現在在第 21 張投影片上，展示的是第四季的年比和季比財務表現。

We generated net product revenues in the quarter of approximately $69.4 million, which is up 413% from Q4 of 2023 and 55% from Q3 of this year. For all the reasons outlined by Frank and Todd, we believe we are still very much in the early stages of our growth with significant upside remaining.

我們本季的淨產品收入約為 6,940 萬美元，較 2023 年第四季成長 413%，較今年第三季成長 55%。基於弗蘭克和托德所概述的所有原因，我們相信我們仍處於成長的早期階段，並且仍具有巨大的上升空間。

In January, ahead of the JPM conference, we pre-announced unaudited product sales of approximately $63 million. While we outpaced that estimate a bit in terms of actual sales in Q4, the amount by which we beat it, was principally due to a reduction in reserves we were holding for product returns of $4.1 million excluding this non-recurring adjustment.

今年 1 月，在 JPM 會議召開之前，我們預先宣布了未經審計的產品銷售額約為 6,300 萬美元。雖然我們第四季度的實際銷售額略微超出了預期，但超出的金額主要是由於我們為產品退貨持有的儲備金減少了 410 萬美元（不包括這項非經常性調整）。

We had net product revenues of $65.3 million for the fourth quarter. That non-recurring amount should be excluded for forward-look calculations.

我們第四季的淨產品收入為 6,530 萬美元。此非經常性金額應排除在前瞻性計算之外。

For the fourth quarter, our R&D expenses were $14.5 million which is down 39% from $23.8 million in the fourth quarter of 2023, due to decreases in the development cost of topical Roflumilast programs, and down approximately 26% compared to the third quarter of '24 this year.

第四季度，我們的研發費用為 1,450 萬美元，較 2023 年第四季的 2,380 萬美元下降 39%，原因是外用羅氟司特專案開發成本下降，與今年 24 年第三季相比下降約 26%。

The reduction in R&D expenses was also due in part to a one-time Q4 credit of $3 million we received related to a closeout of our Roflumilast studies.

研發費用的減少也部分歸因於我們收到的與羅氟司特研究結束相關的第四季度一次性 300 萬美元信貸。

SG&A expenses were $57.6 million for the fourth quarter and -- of 2024 versus $48.7 million in the same period last year, up 18% as we invested in our commercial organization in our current and future launches. SG&A expenses were essentially flat as compared to last quarter.

2024 年第四季的銷售、一般及行政支出為 5,760 萬美元，而去年同期為 4,870 萬美元，成長 18%，原因是我們在當前和未來推出的商業組織上進行了投資。銷售、一般及行政開支與上一季相比基本持平。

Our continued strong revenue growth supports our belief that we are investing appropriately in the tremendous growth potential of our ZORYVE portfolio. And we continue to believe that we will reach cash breakeven in 2026.

我們持續強勁的營收成長支持了我們的信念，即我們正在對 ZORYVE 產品組合的巨大成長潛力進行適當的投資。我們仍然相信，我們將在 2026 年實現現金收支平衡。

On slide 22, for the full year '24, we generated net product revenues of $166.5 million, which is up 471% year over year. Total revenues in 2024 were $196.5 million, up 230% year over year. Based on the ZORYVE revenue run rate we saw in Q4, we ended the year at an annual run rate of approximately $250 million in product sales.

在投影片 22 上，24 年全年，我們創造的淨產品收入為 1.665 億美元，年增 471%。2024 年總營收為 1.965 億美元，年增 230%。根據我們在第四季度看到的 ZORYVE 收入運行率，我們今年年底的產品銷售額年運行率約為 2.5 億美元。

Frank and Todd have highlighted the tailwinds for the full-year 2025 and beyond, that should allow us to build on this impressive growth, including new indications, expansion into government payers, broadening of our prescriber base, and our efforts to take meaningful share from topical steroids.

弗蘭克和托德強調了 2025 年全年及以後的順風趨勢，這將使我們能夠在這一令人印象深刻的增長基礎上再接再厲，包括新的適應症、擴展到政府付款人、擴大我們的處方者基礎，以及努力從外用類固醇中奪取有意義的份額。

For the full-year 2024, our R&D expenses were $76.4 million, down 31% from 2023, due to decreases in development costs of topical Roflumilast programs. Recall that a large portion of the expenses included in the R&D line item are comprised of medical affairs activities supporting ZORYVE commercialization, which will not decline over time.

2024 年全年，我們的研發費用為 7,640 萬美元，較 2023 年下降 31%，原因是外用羅氟司特專案的開發成本下降。回想一下，研發項目中的大部分費用是支持 ZORYVE 商業化的醫療事務活動，這些費用不會隨著時間的推移而減少。

In 2025, we expect a similar level in R&D as in 2024, a year in which we will advance ARQ-234 and 255 with minimal spend for our topical Roflumilast programs and continued investment in our medical affairs activities.

2025 年，我們預期研發水準與 2024 年相似，這一年我們將推進 ARQ-234 和 255，盡量減少對局部羅氟司特計畫的支出，並繼續投資於我們的醫療事務活動。

SG&A expenses were $229.4 million for the full-year 2024 versus $185.1 million in the same period last year, up 24% to support a significantly higher level of revenue growth.

2024 年全年銷售、一般及行政支出為 2.294 億美元，而去年同期為 1.851 億美元，成長 24%，以支持更高水準的營收成長。

In 2025, we do expect an increase in SG&A expenses, considering our launch in scalp-and-body psoriasis, the annualized cost of the increased sales force, and sustained marketing efforts supporting all ZORYVE indications.

考慮到我們在頭皮和身體牛皮癬領域的推出、增加銷售隊伍的年化成本以及支持所有 ZORYVE 適應症的持續營銷努力，我們確實預計 2025 年銷售、一般及行政費用會增加。

On slide 23, you can see we had cash and marketable securities of $228.6 million on our balance sheet as of December 31, 2024, which translates to a cash burden from operations in the quarter of less than $1 million.

在投影片 23 上，您可以看到，截至 2024 年 12 月 31 日，我們的資產負債表上有 2.286 億美元的現金和有價證券，這意味著本季的經營現金負擔不到 100 萬美元。

We had great revenue growth in Q4 and lower expenses through the R&D credit I noted earlier. And some of our expenses rolling over into 2025. This, along with a few working capital items led to our low cash burn.

我們第四季的收入大幅成長，而且透過我之前提到的研發信貸，我們的支出也降低了。我們的部分開支將延續至 2025 年。這一因素加上一些營運資金項目導致我們的現金消耗較低。

Q4 was a bit of an anomaly. But moving forward, we expect higher SG&A and modestly higher cash burn in the first quarter. And as Frank indicated previously, we expect our quarterly cash burn to continue trending down in the long run as our revenues grow and we reach cash flow breakeven sometime in 2026.

Q4 有點異常。但展望未來，我們預期第一季銷售、一般及行政開支將增加，現金消耗也將小幅增加。正如弗蘭克之前所說，隨著我們收入的增長並在 2026 年某個時候達到現金流盈虧平衡，我們預計我們的季度現金消耗將在長期內繼續呈下降趨勢。

In October, we repaid $100 million of debt facility, which will significantly lower our interest expense in 2025. We have the option to redraw that $100 million in whole or in part at our discretion in the middle of 2026, providing us with significantly enhanced flexibility.

10月份，我們償還了1億美元的債務，這將大大降低我們2025年的利息支出。我們可以選擇在 2026 年中期自行決定全部或部分重新提取這 1 億美元，從而大大提高我們的靈活性。

We believe our current capital, together with the available $100 million in debt, our growing revenue stream and improving economies of scale, will allow the company to reach cash flow breakeven in 2026, even as we continue to invest in the business for continued growth and long-term durability.

我們相信，我們目前的資本，加上可用的 1 億美元債務、不斷增長的收入來源和不斷提高的規模經濟，將使公司在 2026 年實現現金流收支平衡，即使我們繼續投資於業務以實現持續增長和長期持久性。

To reiterate what we have said previously, we do not expect to return to the equity market to support our existing business. With that, I'll hand it back to Frank for some closing comments.

重申我們之前所說的話，我們不希望重返股票市場來支持我們現有的業務。說完這些，我將把話題交還給弗蘭克，請他做一些結束語。

Thanks, David. So in closing, let me reiterate our three key messages. Our business is strong as we wrap up a stellar 2024. We look forward to continued growth of the ZORYVE portfolio in 2025 and beyond. And the key to that continued growth is the growing shift from topical steroids to non-steroidals in our large target market of 17 million patients.

謝謝，大衛。最後，讓我重申我們的三個關鍵訊息。我們即將迎來輝煌的 2024 年，業務發展勢頭強勁。我們期待 ZORYVE 產品組合在 2025 年及以後繼續成長。而持續成長的關鍵在於，在我們擁有 1,700 萬名患者的龐大目標市場中，外用類固醇藥物逐漸轉向非類固醇藥物。

After our significant efforts last year, ZORYVE is now the number one, branded topical product. But as you saw, this is just a drop in the bucket of the enormous topical steroid market.

經過我們去年的巨大努力，ZORYVE 現已成為排名第一的品牌外用產品。但正如你所看到的，這只是龐大的外用類固醇市場的滄海一粟。

We're excited about the opportunity ahead of us and in 2025, we will continue to tackle it comprehensively, using multiple levers like our new indications and label expansions, our primary care partner, our consumer outreach with OBJ, and our continuous -- continuously improving reimbursement coverage.

我們對眼前的機會感到興奮，並在 2025 年繼續全面應對這一機遇，利用多種手段，例如我們的新適應症和標籤擴展、我們的初級保健合作夥伴、我們與 OBJ 的消費者拓展以及我們持續不斷的——不斷改善的報銷覆蓋範圍。

Lastly, as David said, we have line of sight to break even in 2026, which will further improve the overall characteristics of our business and create optionality for even more growth.

最後，正如大衛所說，我們預計在 2026 年實現收支平衡，這將進一步改善我們業務的整體特徵，並為進一步的成長創造選擇權。

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

接下來，我們將結束本次電話會議並開始問答環節。

(Operator Instructions)

（操作員指令）

Chrome Prohead with Morgan Stanley Hill and is now open.

Chrome Prohead 與 Morgan Stanley Hill 合作，現已開幕。

Hi, good afternoon. Thank you for taking our questions. So we have two, just one on the quarterly release.

嗨，下午好。感謝您回答我們的問題。因此，我們有兩個，只有一個是季度發布。

So you clarified a big chunk of the delta between the pre-announcement and the actual 4Q results of roughly $69 million. But for the residual roughly $2 million, was that related to inventory or another factor if you could clarify? That would be helpful.

所以你澄清了預先公告和實際第四季度結果之間的很大一部分差額，大約 6900 萬美元。但對於剩餘的約 200 萬美元，是否與庫存有關，還是與其他因素有關，您能澄清一下嗎？那將會很有幫助。

And then secondly, set a question for you on IP. There's been some investor interesting questions in the upcoming claim construction hearing, in your ongoing IP lawsuits. So I just wanted to ask if you could speak to your kind of confidence in protecting the IP for a refranchise going forward? And how you feel about that process? Thank you.

其次，為你設定一個關於 IP 的問題。在你們正在進行的智慧財產權訴訟中，即將舉行的權利要求解釋聽證會上，投資人提出了一些有趣的問題。所以我想問一下，您是否可以談談您對未來保護 IP 以進行再特許經營的信心？您對這個過程有何感受？謝謝。

Okay. Sure, Vikram. Thanks for your questions. So, David, maybe can you go in a little more detail around the delta between what we had pre-announced for Q4 and this final Q4 print and what was driving that?

好的。當然，維克拉姆。感謝您的提問。那麼，大衛，您能否更詳細地介紹一下我們預先宣布的第四季度業績與最終第四季度業績之間的差異，以及造成這種差異的原因是什麼？

Sure. A couple of things I'd say. First of all, as I mentioned, we did make an adjustment for the reserves we had accumulated for product returns. That total adjustment was essentially a bit over $5 million. But a million in change of that was due to the fourth quarter of 2024 itself.

當然。我想說幾件事。首先，正如我所提到的，我們確實對產品退貨累積的儲備進行了調整。總調整額基本上略高於 500 萬美元。但其中一百萬的變化是由於 2024 年第四季本身造成的。

So we can't refer to that as an adjustment. So that's a part of it. The other part I would chalk up to us being conservative when we pre-announced revenue, simple as that.

所以我們不能稱之為調整。這是其中的一部分。另一部分原因我認為是我們在預先公佈收入時比較保守，就這麼簡單。

And then Vikram, with regard to your second question, I think it's a completely understandable question when we get a lot. What I can say at this point is you made reference to the upcoming Markman hearing, that's scheduled to occur in April 2025.

然後維克拉姆，關於你的第二個問題，我認為當我們得到很多東西時，這是一個完全可以理解的問題。我現在可以說的是，您提到了即將舉行的馬克曼聽證會，該聽證會定於 2025 年 4 月舉行。

You can review what's publicly available on the court docket. But we can't comment beyond that specifically [vis-a-vis] the Markman hearing. What I will say is that as we have said before, we are very confident in the strength of our IP portfolio and our ability to maintain exclusivity of ZORYVE. And we intend to vigorously defend our intellectual property rights as appropriate.

您可以查看法庭檔案中公開的內容。但我們無法就馬克曼聽證會發表進一步具體評論。我想說的是，正如我們之前所說的，我們對我們的 IP 組合的實力以及保持 ZORYVE 獨家權的能力非常有信心。我們打算適當地大力捍衛我們的智慧財產權。

Fair enough. Thank you.

很公平。謝謝。

Tyler Van Buren, Cowen.

泰勒·範布倫，考恩。

Hey, guys. Thanks and congratulations on the exceptional execution of commercial front heading into the year end.

嘿，大家好。感謝並祝賀您在年底前商業戰線的出色表現。

So I think many people were surprised by the growth in weekly prescriptions that we saw with ZORYVE cream, heading into year end and quarter over quarter in Q4, relative to what we saw in Q3 versus Q2.

因此，我認為許多人都對 ZORYVE 乳膏的每週處方量增長感到驚訝，相對於第三季度與第二季度相比，第四季度的處方量環比增長也令人吃驚。

So can you elaborate on the impact? I mean you talked about multiple drivers, but can you elaborate on the impact that the salesforce expansion had? How much it was expanded by and whether you'll continue to expand it as sales increase moving forward?

那麼您能詳細說明一下其影響嗎？我的意思是您談到了多個驅動因素，但您能詳細說明一下銷售隊伍擴張的影響嗎？擴大了多少？

Yeah. So Tyler, just to clarify, are you asking specifically about the growth of the cream or the 0.3 cream? Or you're just asking generally about the growth that we're seeing across the board in prescriptions?

是的。所以泰勒，只是想澄清一下，你具體問的是奶油的增長還是 0.3 奶油的增長？或者您只是一般性地詢問我們看到的處方藥總體增長情況？

I generally about the growth, I'd be curious to hear about the cream and psoriasis if you have any additional color there since there was really significant quarter-over-quarter growth for Q4 versus Q3 as opposed to Q3 versus Q2.

我通常會談論增長情況，如果您有其他詳細信息，我很想听聽有關面霜和牛皮癬的情況，因為與第三季度相比，第四季度與第二季度相比，環比增長確實非常顯著。

Sure. Yeah, Todd, can you maybe go into a little more detail about our views specifically with regard to Q4 and the growth at both the portfolio level and then maybe if you have any color around each of the individual SKUs?

當然。是的，Todd，你能否更詳細地介紹一下我們的看法，特別是關於第四季度以及產品組合層面的增長，然後你是否能對每個單獨的 SKU 進行詳細說明？

Portfolio growth as mentioned, portfolio growth is primarily driven by volume growth, the slide on net revenue, a slight increase with with gross the net.

如上所述，投資組合成長主要受銷量成長、淨收入下滑以及毛收入和淨收入略有增加的推動。

But nonetheless, as mentioned, we did see a growth across the entire product portfolio, which we're very encouraged by more specific to ZORYVE cream for psoriasis. We think about the -- what I'll call the versatility effect that I mentioned earlier within my script.

但儘管如此，正如前面提到的，我們確實看到整個產品組合的增長，尤其是針對牛皮癬的 ZORYVE 乳膏，我們對此感到非常鼓舞。我們思考——我將其稱為我之前在腳本中提到的多功能性效果。

Providers are now being able to get a clinical experience with ZORYVE across three different products across, one for Seb Derm, one for atopic dermatitis, and now psoriasis. And that's amplifying the increased utilization of these products across the portfolio to include increased utilization of the ZORYVE cream for psoriasis.

現在，服務提供者可以透過 ZORYVE 的三種不同產品獲得臨床體驗，一種用於治療脂漏性皮膚炎，一種用於治療異位性皮膚炎，現在還有牛皮癬。這擴大了這些產品在整個產品組合中的使用率，包括增加了用於治療牛皮癬的 ZORYVE 乳膏的使用率。

So we're very encouraged by that. In reference to the salesforce expansion that we had on June 1, increasing the share of voice. That was definitely a driver of the increased prescription growth that we saw in Q4. And we believe that we are currently right sized for the dermatology market with the portfolio that we're managing today.

因此我們對此感到非常鼓舞。關於我們 6 月 1 日進行的銷售團隊擴張，增加了話語權。這無疑是我們在第四季度看到的處方藥成長的一個驅動因素。我們相信，憑藉我們今天管理的產品組合，我們目前的規模適合皮膚病學市場。

Seamus Fernandez, Guggenheim.

古根漢的謝默斯·費爾南德斯。

Thanks for the question. So just wanted to circle up on the momentum in the business, can you just give us a little bit of color on fourth quarter, how the refills were sort of coming in?

謝謝你的提問。所以只是想概括一下業務的發展勢頭，您能否給我們介紹一下第四季度的情況，補充情況如何？

Was there clear proof from your perspective that there was an increase in the refill rate? And just wondering how the sort of the estimate of the tubes per year is actually coming in relative to your expectations on a go-forward basis as we think about the growth in the overall market?

從您的角度來看，是否有明確證據顯示補貨率增加？我只是想知道，當我們考慮整個市場的成長時，每年管道的估計產量實際上與您的預期相比如何？

And then the second question is just very quickly, the consensus is kind of between [280 million to 285 million] this year. Just wondering how you guys are thinking about the opportunity for sustained growth and the opportunities to see the scripts, perhaps, maintain this very strong linear trajectory that we saw through the balance of 2024. Thanks.

然後第二個問題很簡單，今年的共識是在 [2.8 億到 2.85 億] 之間。只是想知道你們如何看待持續成長的機會以及看到劇本的機會，也許可以保持我們在 2024 年平衡中看到的非常強勁的線性軌跡。謝謝。

Sure. Okay. If the Arcutis team, if you guys could pause just a second before you start answering your question, I think the very front end of your question, answers are getting clipped off.

當然。好的。如果 Arcutis 團隊，如果你們可以在開始回答問題之前停頓一秒鐘，我認為你們問題的最前端的答案被截斷了。

So Todd, if you could comment maybe on the momentum in Q4 and particularly around what we're seeing with refills, the indicators of the pull forward that we believe happened. And then also, maybe comment on our current thinking around two-per-year consumption.

所以 Todd，你能否評論一下第四季度的勢頭，尤其是我們看到的補充情況，以及我們認為已經發生的提前拉動的指標。然後，也許可以對我們目前關於每年兩次的消費的想法發表一些評論。

And then also, if you could maybe touch on the opportunity for sustained growth again. And then David, I think it'd be helpful if you can give maybe some color around our current thinking around consensus for 2025.

另外，您是否可以再次談談持續成長的機會。然後大衛，我認為如果你能對我們目前對 2025 年共識的想法進行一些闡述的話會很有幫助。

Yeah, Frank. I'll start. Relative to the the twos per year as we've communicated before, we expect ZORYVE cream 0.3% for psoriasis on the average tubes per patient per year to be around two tubes per year. And for ZORYVE foam, for Seb Derm, likely around two to three cans per year.

是的，弗蘭克。我先開始。相對於我們之前溝通過的每年兩支，我們預計用於治療牛皮癬的 0.3% ZORYVE 乳膏平均每位患者每年的用量約為兩支。對於 ZORYVE 泡沫和 Seb Derm，每年大概需要兩到三罐。

For atopic dermatitis, it's still early within the launch. But we expect on average two- to three-year for an atopic dermatitis patient.

對於異位性皮膚炎來說，現在還處於起步階段。但我們預期異位性皮膚炎患者的存活期平均為兩到三年。

And then in reference to Q4 and refills, we're very encouraged by the refill rates with ZORYVE cream for psoriasis, which was around 40% of the total volume as refills. And then for the ZORYVE for Seb Derm, it was around 38% refills. And atopic dermatitis, still early in the launch and for the refills, but nonetheless, once we mature that product, it will likely be similar to ZORYVE cream and psoriasis around 40% within the refills.

然後參考第四季和補充量，我們對 ZORYVE 牛皮癬霜的補充率感到非常鼓舞，其補充量約佔總補充量的 40%。對於 ZORYVE for Seb Derm，其補充量約為 38%。至於異位性皮膚炎，仍處於推出和補充的早期階段，但儘管如此，一旦我們成熟該產品，它可能會與 ZORYVE 乳霜和牛皮癬在補充裝中的相似度約為 40%。

As Frank mentioned, we did see some pull forward in December from Q1 due to patients wanting to get their prescriptions refilled prior to their deductibles being resets. So we did see some pull forward into December.

正如弗蘭克所提到的，我們確實看到 12 月的費用較第一季有所提前，因為患者希望在自付額重置之前重新配藥。因此我們確實看到了 12 月的一些拉動。

But nonetheless, we're very encouraged with the prescription trends and growth here in Q1, albeit, that we still that we had that pull forward from January into December. We continue to see robust prescription growth.

但儘管如此，我們對第一季的處方趨勢和成長感到非常鼓舞，儘管我們仍然認為這種趨勢從 1 月提前到了 12 月。我們繼續看到處方藥的強勁成長。

Despite some of the typical disruption that we see in the first quarter with patients, switching insurances have to be recertified for product like ZORYVE and we fully expect to continue this momentum throughout 2025.

儘管我們在第一季看到了患者面臨的一些典型中斷，但像 ZORYVE 這樣的產品必須重新認證保險轉換，我們完全預計這一勢頭將在 2025 年繼續保持。

I hope I'm not being cut off. As for the estimates that are out there, we are very comfortable with the consensus out there for the full year of 2025, definitely comfortable. I think it's important to think a lot about how those revenues will be distributed across quarters for the year.

我希望我沒有被切斷。至於現有的估計，我們對 2025 年全年的共識非常滿意，絕對滿意。我認為認真思考這些收入在一年中各個季度間的分配是十分重要的。

You've heard Todd say a couple of times now that first quarter for the products like many, many other products can be affected by a slight change and gross to net as deductibles get reset, and so forth. So well, obviously, prescription growth is extremely robust, that there can be an impact on revenue. I'll just think about how to distribute that [280] to [285] across the four quarters.

您可能已經聽過托德說過幾次了，由於免賠額的重置等，這些產品的第一季就像許多其他產品一樣，可能會受到輕微變化以及毛利與淨額的影響。顯然，處方藥成長非常強勁，這可能會對收入產生影響。我只會考慮如何將 [280] 到 [285] 分配到四個季度。

Serge Belanger, Needham.

塞爾吉·貝朗格，尼德漢姆。

Hi. Good afternoon. A couple of questions. The first one, I guess a follow up to the guidance or the consensus number and how we should model 2025.

你好。午安.幾個問題。第一個，我想是跟進指導或共識數字，以及我們應該如何模擬 2025 年。

On slide 6, you highlighted about 4 million patients are covered by Medicare and Medicaid, just curious how many of them had coverage at the start of the year and when you expect that they will have coverage throughout the year?

在第 6 張投影片上，您強調了大約 400 萬患者享受醫療保險和醫療補助，您只是好奇其中有多少人在年初享受了保險，以及您預計他們何時會在全年享受保險？

And then, second question, more of a broader strategy question. David highlighted how well the company's capitalized, and the near-term breakeven point is on the horizon in 2026.

然後，第二個問題，更多的是一個更廣泛的策略問題。David 強調了公司​​的資本充足率，並且近期的損益平衡點將在 2026 年實現。

So I was just curious, how much of a priority in the near to medium term is profitability for the company, given that you do have a pipeline, and you've discussed [BD] in the past? Thanks.

所以我很好奇，考慮到你們確實有管道，而且過去也討論過 [BD]，從近期到中期來看，公司的盈利能力有多大的優先考慮事項？謝謝。

Sure. So Todd, if you could maybe address the -- and so you're asking about the amount of Medicare and Medicaid patients had coverage at the beginning of 2025 or the beginning of 2024?

當然。那麼托德，你能否回答一下這個問題——你問的是 2025 年初或 2024 年初有多少醫療保險和醫療補助患者受到覆蓋？

'25.

'25。

Okay. Yeah. So Todd, if you could maybe talk a little bit more about where we stand with regard to Medicare and Medicaid as of the beginning of this year and how that will translate into the patient opportunity for 2025. And then, when you're done talking about that, I'll come back to the question around profitability and the pipeline.

好的。是的。所以托德，你能否再多談一下今年年初我們在醫療保險和醫療補助方面的現狀，以及這將如何轉化為 2025 年的患者機會。然後，當你談完這個問題後，我會回到有關獲利能力和管道的問題。

Yeah. Thank you, Frank, for the question. And specifically to Medicaid, we're very pleased with the Medicaid coverage that we've been able to secure up to the start of 2025. And that would be that 1 in 2 Medicaid beneficiaries now have access to ZORYVE.

是的。謝謝弗蘭克提出的問題。具體到醫療補助，我們對能夠確保到 2025 年初的醫療補助覆蓋範圍感到非常滿意。這意味著每 2 名醫療補助受益人中就有 1 名現在可以使用 ZORYVE。

And one of the things, very important to highlight, is not only the improved access we've had relative to Medicaid, but the quality of that access. And what I mean by that, if you, as an example, if you look at the state of California with Medi-Cal, there is no step edit for ZORYVE. So it's a first-line therapy within the state of California.

其中非常重要的一點是，我們不僅獲得了比醫療補助更好的醫療服務，而且醫療服務的品質也得到了提升。我的意思是，舉個例子，如果你看看加州的 Medi-Cal，你會發現 ZORYVE 沒有步驟編輯。所以它是加州的一線治療方法。

If we look at the state of Florida, you have to step through ZORYVE to be able to access the VTAMA within psoriasis. So high-quality Medicaid coverage and 1 in 2 Medicaid beneficiaries have access to ZORYVE.

如果我們看看佛羅裡達州，您必須通過 ZORYVE 才能訪問牛皮癬內的 VTAMA。因此，高品質的醫療補助覆蓋和一半的醫​​療補助受益人可以使用 ZORYVE。

Specifically to Medicare Part B, we can continue to have our discussions and negotiations with the Medicare Part B PBMs as they navigate the implementation of the IRA, the Inflation Reduction Act.

具體來說，對於 Medicare B 部分，我們可以繼續與 Medicare B 部分的 PBM 進行討論和談判，幫助他們實施 IRA，即《通貨膨脹削減法案》。

Implementation of the IRA has operationally slowed those discussions down in that process with the PBM. But nonetheless, we're very optimistic that we'll be able to accelerate these discussions and continue to improve on our Part D access as we navigate through 2025.

IRA 的實施在操作上減緩了與 PBM 在此過程中的討論。但儘管如此，我們非常樂觀地認為，我們將能夠加快這些討論，並在 2025 年到來之際繼續改善我們的 D 部分訪問權限。

And then Serge, with regard to your question around profitability, this is obviously something that that the leadership team thinks a lot about at Arcutis. I think getting the cash break even is very important because it gives us a degree of operational flexibility as we think about running the business for the future.

然後 Serge，關於您提到的盈利能力問題，這顯然是 Arcutis 領導團隊非常重視的問題。我認為實現現金收支平衡非常重要，因為當我們考慮未來業務營運時，它為我們提供了一定程度的營運彈性。

The first priority has to continue to be investing in the growth of ZORYVE. And as I think Todd mentioned during the call, we feel like we have the right level of investment. It's something that we constantly evaluate whether there are incremental opportunities or whether there are opportunities to save money in terms of ZORYVE investment.

首要任務是繼續投資 ZORYVE 的發展。我認為托德在通話中提到，我們覺得我們的投資水準是適當的。我們不斷評估 ZORYVE 投資方面是否存在增量機會或是否存在省錢的機會。

But we feel we're at the right point right now in terms of investing in ZORYVE growth. We do have a number of pipeline programs as Patrick outlined. And those will hopefully progress, but they're fairly early stage, so we don't expect really significant burn on those programs in the near term.

但我們認為，就投資 ZORYVE 發展而言，現在正處於正確的時機。正如帕特里克所概述的，我們確實有許多管道項目。希望這些項目能夠取得進展，但現在還處於相當早期的階段，因此我們預期短期內這些項目不會產生太大的損失。

But they eventually will impact our spend. And then, with regard to business development, I would say that we remain very opportunistic. We're always looking at interesting opportunities. And opportunities where we feel like we can grow shareholder value. But we don't believe that that business development is something that we have to do, right?

但它們最終會影響我們的支出。然後，關於業務發展，我想說我們仍然非常具有機會主義精神。我們一直在尋找有趣的機會。我們覺得我們還有機會增加股東價值。但我們不認為業務發展是我們必須要做的事情，對嗎？

It's not an imperative given the strength of our existing franchise and our internal pipeline. So it's sort of an odd question as a biotech company to think about profitability. We're really focused on driving revenue growth and driving shareholder value first.

考慮到我們現有特許經營權和內部管道的實力，這並不是必要的。因此，對於一家生技公司來說，考慮獲利能力是一個有點奇怪的問題。我們真正關注的是首先推動收入成長和推動股東價值。

And I think, us paying dividends is probably not the right way to do that, at least not for the foreseeable future. So we'll continue to be very judicious in our investments, whether that's vis-a-vis [rev] or the pipeline or business development.

我認為，支付股利可能不是正確的做法，至少在可預見的未來不是。因此，我們將繼續非常審慎地進行投資，無論是相對於[rev]還是管道或業務發展。

But if we do see opportunities to use the capital that we have to grow shareholder value, then we'll certainly take advantage of those opportunities.

但如果我們確實看到利用現有資本來增加股東價值的機會，那麼我們肯定會利用這些機會。

Thank you.

謝謝。

Mizuho Group.

瑞穗集團。

Hey guys, thanks for taking your questions. So I have two questions. First one is with the upcoming approval of the foam and the psoriasis, just wondering, what is the indication that you're expecting? Is it psoriasis in general or is it like psoriasis with scalp involvement?

嘿夥計們，謝謝你們回答問題。我有兩個問題。首先是泡沫和牛皮癬即將獲得批准，只是想知道，您期待的跡像是什麼？它是一般的牛皮癬嗎？

And how do you think that this -- what's the strategy for? This indication for this foam product, you -- do you think that they'll probably candalize the more of the cream? Or you expect more patients to convert to the foam, just wondering what your thoughts are there? And secondly, what do you expect from the phase 1b data for ARQ-255? Thanks.

您認為這 — — 策略是什麼？對於這種泡沫產品，您認為他們可能會生產更多的乳霜嗎？或者您希望更多的患者轉而使用泡沫，只是想知道您的想法是什麼？其次，您對 ARQ-255 的 1b 階段資料有何期待？謝謝。

Sure. So Patrick, maybe if you could start out by addressing the 255 question and what we expect from our phase 1 study? And then, if you could also maybe comment on what we what we filed for and what we expect in terms of the indication for the expanded indication for ZORYVE foam?

當然。那麼派崔克，您能否先回答第 255 個問題以及我們對第一階段研究的期望？然後，您是否可以評論一下我們所提交的內容以及我們對 ZORYVE 泡沫擴大適應症的期望？

And then Todd, if you could go into the strategy for the foam launch in scalp. And how we see that playing with the with the 0.3 cream?

然後 Todd，您能不能講講頭皮泡沫發射的策略。我們如何看待 0.3 奶油的使用？

Absolutely. Thanks. Yeah. So starting with 255, this is a phase 1b study, we have -- we had 12 healthy volunteers. Then we had a 30-plus alopecia areata patients that were treated for three months.

絕對地。謝謝。是的。因此從 255 開始，這是一項 1b 期研究，我們有 12 名健康志願者。當時我們有30多位斑禿患者接受了三個月的治療。

Our goal with this is really to understand the kind of pKa exposure safety and tolerability first in this early-stage trial. And then also, with the inclusion of the alopecia areata patients, to get an understanding from both a biomarker and an early clinical response, whether or not there's some indication that we were getting an engagement of the target, which has been a challenge for topical treatment of alopecia areata.

我們的目標是在早期試驗中首先了解 pKa 暴露的安全性和耐受性。然後，同時納入斑禿患者，從生物標記和早期臨床反應中了解是否有跡象表明我們正在參與目標，這對斑禿的局部治療來說是一個挑戰。

And so, we're really going to be focusing on those safety and tolerability data primarily, and keep in mind this is a three-month treatment and the pivotal timeline for a [LB Gerry] trial is typically six months of therapy.

因此，我們實際上將主要關注那些安全性和耐受性數據，請記住這是一個為期三個月的治療，而 [LB Gerry] 試驗的關鍵時間表通常是六個月的治療。

So we would really try, just be seeing the first evidence of efficacy in that readout. Now moving on to the scalp-and-body indication for psoriasis with the foam. In our pivotal trial, we had co-primary endpoints of body IGA as well as scalp IGA. And so we anticipate the indication to be inclusive of all psoriasis.

因此我們會認真嘗試，只是在讀數中看到療效的第一個證據。現在讓我們來談談使用泡沫治療頭皮和身體牛皮癬的情況。在我們的關鍵試驗中，我們將身體 IGA 和頭皮 IGA 作為共同主要終點。因此我們預計該適應症將涵蓋所有牛皮癬。

But then also, specifically, calling out scalp in a similar way reminiscent of what we saw with the cream indication, where we had a broad indication for the treatment of psoriasis. But then, it specifically called out inclusive of those patients with [intravenous] disease. So we would anticipate that kind of broad indication for the foam as well.

但是然後，具體地，以類似的方式呼喚頭皮，讓人想起我們在乳霜適應症中看到的，我們對治療牛皮癬有廣泛的適應症。但隨後，它特別呼籲包括那些患有 [靜脈] 疾病的患者。因此，我們預期泡沫也會有這種廣泛的適應症。

Yeah. And then, I'll respond relative to the strategy for the ZORYVE foam for scalp-and-body psoriasis. We're incredibly excited about this upcoming approval because we want to be able to differentiate our offering to both dermatologists and patients.

是的。然後，我將針對 ZORYVE 泡沫治療頭皮和身體牛皮癬的策略做出回應。我們對即將獲得的批准感到非常興奮，因為我們希望能夠為皮膚科醫生和患者提供差異化的產品服務。

And what I mean by that is we want to be able to create and present optionality and choice, mean that we're going to provide a ZORYVE foam formulation for psoriasis and a ZORYVE cream to where the provider and the patient have the choice, what is best suited for that patient to be determined by their dermatologist.

我的意思是，我們希望能夠創造和提供可選性和選擇，這意味著我們將提供用於治療牛皮癬的 ZORYVE 泡沫配方和 ZORYVE 乳膏，讓供應商和患者可以選擇，由皮膚科醫生決定最適合患者的方案。

And you have to remember relative to psoriasis. And this pertains to the ZORYVE foam is that for psoriasis patients, approximately 50% of them have some type of scalp involvement.

你必須記住與牛皮癬有關的事情。這與 ZORYVE 泡沫有關，對於牛皮癬患者來說，大約 50％ 的人有某種類型的頭皮問題。

So we believe by offering that type of choice and optionality, we can drive significant conversions from the steroid market over to ZORYVE foam or to ZORYVE cream. And this will accelerate the entire market as far as the uptake of these products and the conversion from steroids over to the two, differentiate offerings that we'll have for providers and patients in psoriasis.

因此，我們相信，透過提供這種選擇和可選性，我們可以推動類固醇市場向 ZORYVE 泡沫或 ZORYVE 乳膏的重大轉變。這將加速整個市場對這些產品的吸收以及從類固醇到兩種產品的轉變，我們將為牛皮癬的提供者和患者提供差異化產品。

If I could maybe just -- add just a little bit more color cause we continue to get this question. I think that it is wrong to think about the foam cannibalizing the cream.

如果我可以的話——再添加一點顏色，因為我們會繼續得到這個問題。我認為泡沫會蠶食奶油的想法是錯的。

What I think might happen is that there will be a shift in the growth pattern in psoriasis from cream to foam. But I think it's very unlikely that the patient that's on the cream is actually going to switch then to the foam.

我認為可能會發生的是，牛皮癬的生長模式將從乳霜轉變為泡沫。但我認為，使用乳膏的患者其實不太可能改用泡沫藥物。

So cannibalization is probably not the right way to think about this. And ultimately what matters to us and what matters to shareholders is the growth of total ZORYVE 0.3 in the psoriasis market.

因此，蠶食可能不是思考這個問題的正確方式。最終對我們和股東來說重要的是 ZORYVE 0.3 在牛皮癬市場的整體成長。

And we're quite confident that the addition of the foam and the addition of the scalp-and-body indication is going to accelerate the growth of 0.3 cream and foam in psoriasis and put us in a very strong position.

我們非常有信心，泡沫的加入以及頭皮和身體適應症的增加將加速 0.3 牛皮癬霜和泡沫的增長，並使我們處於非常有利的地位。

Okay, thank you.

好的，謝謝。

Kambiz Yazdi, Jeffries.

坎比茲·亞茲迪，傑弗里斯。

Hey, team. Thanks for the questions. Just a couple for me. What proportion of 4Q sales are attributable to the Kowa PCP partnership? And the second question I have is do you expect one Q OpEx to remain roughly in line with 4Q excluding commissions to Kowa? Will commissions Kowa be included in the SG&A line of [0.2op]? Thank you.

嘿，團隊。感謝您的提問。對我來說只有一對。第四季的銷售額中，有多少比例歸功於與 Kowa PCP 的合作？我的第二個問題是，您是否預計第一季的營運支出（不包括支付給 Kowa 的佣金）將與第四季大致持平？佣金 Kowa 是否會納入銷售、一般及行政費用[0.2op]？謝謝。

Sure. I think probably David, you can address both of those. If you could address what contribution from Kowa was in what the contribution from Kowa was in Q4. And then, also our thoughts around Q1 OpEx with and without the Kowa commission.

當然。我認為大衛也許可以解決這兩個問題。如果您可以解釋一下 Kowa 在第四季度的貢獻是什麼的話。然後，我們還討論了在有和沒有 Kowa 委員會的情況下第一季的營運支出的想法。

Sureas. As we've been saying for several months now, the Kowa sales force and their efforts really got started in September. And so, at no time, did we really expect a meaningful contribution from them in 2024.

當然。正如我們幾個月來一直在說的那樣，Kowa 銷售團隊及其工作真正開始於 9 月。因此，我們從來沒有真正期望過他們會在 2024 年做出有意義的貢獻。

And in fact, while it was not certainly a non-zero number, it was not a significant amount. We do expect a meaningful contribution in 2025. The commission that we pay Kowa is will be in the SG&A line. So you will see an increase there.

事實上，雖然它肯定不是一個非零數字，但它不是一個很大的數字。我們確實期待在 2025 年做出有意義的貢獻。我們支付給 Kowa 的佣金將屬於銷售、一般及行政開支項目。因此你會看到那裡有所增長。

And what we've committed to is that when that contribution becomes meaningful, that we will give information as we report quarterly results. We will give information on volumes and commissions, and so forth. So that people understand the magnitude of that contribution.

我們承諾，當這種貢獻變得有意義時，我們將在報告季度業績時提供資訊。我們將提供有關數量和佣金等的資訊。以便人們了解這項貢獻的重要性。

[Doug Sam, HC Renmar]

[道格·薩姆，HC Renmar]

Hi. Good afternoon. Thanks for taking the questions. And congrats on the progress on the corner. Just one question for me, you spoke about sort of the feedback you're getting in terms of clinicians wanting to move away from steroids.

你好。午安.感謝您回答這些問題。並祝賀角落的進展。我只想問一個問題，您談到了關於臨床醫生希望擺脫類固醇的回饋。

Obviously, I presume payers will continue to sort of want that as a first-line option. So I'm just curious from a reimbursement standpoint how you potentially see that playing out. Do you think that physicians will just try steroids more briefly? Or do you think outright that ZYROVE can become first-light therapist? Thank you.

顯然，我認為付款人將繼續希望將其作為一線選擇。所以我只是好奇，從報銷的角度來看，您可能會如何看待這一結果。您是否認為醫生只會更短暫嘗試使用類固醇？或者您直接認為 ZYROVE 可以成為第一道光治療師？謝謝。

Sure. Yeah. I think that's an important point, probably to clarify. Yeah, I think. And Todd can comment on this too. But I think it's likely that we will continue to see a single step edit through a generic steroid to get to ZYROVE.

當然。是的。我認為這是一個重要的觀點，可能需要澄清一下。是的，我認為。托德也可以對此發表評論。但我認為我們很可能會繼續看到透過通用類固醇進行單步編輯以獲得 ZYROVE。

The numbers that we were talking about on the call represent people who are already on a steroid and therefore have already met the step requirement, right? So this issue of stepping through a topical steroid really is only relevant for the very small percentage of patients who are newly diagnosed or who have not been on any treatment for quite some period of time.

我們在電話中討論的數字代表那些已經服用類固醇並因此已經滿足步數要求的人，對嗎？因此，使用局部類固醇的問題實際上只與極少數新診斷或相當長一段時間未接受任何治療的患者有關。

Typically, the insurance companies will look at any treatment in the last 6 to 12 months, depending on the insurance company. So what I think investors really need to focus on are the 16 million prescriptions out there already for topical steroids, right?

通常，保險公司會審查過去 6 至 12 個月內的任何治療情況，具體取決於保險公司。所以我認為投資人真正需要關注的是目前已有的 1,600 萬張外用類固醇處方，對嗎？

Those are all patients who have met the requirement for the step and the step is irrelevant. And that's where we think the growth opportunity is going to come. And Patrick, maybe you can talk a little bit more as well about the paradigm of steroids in an acute treatment for a chronic disease and how ZYROVE fits into that picture.

這些都是滿足該步驟要求的患者，而該步驟無關緊要。我們認為，成長機會就在這裡。派崔克，也許您還可以再多談談類固醇在慢性病急性治療中的範例，以及 ZYROVE 如何適應這種情況。

Yeah. I think that that's one of the parts of the conversation that I think is going on right now, is about what is the role that steroids have in the management of these diseases. And a lot of the conversation is about the chronic treatment of these chronic diseases.

是的。我認為這是目前正在進行的討論的一部分，即類固醇在這些疾病的治療中發揮什麼作用。很多討論都是關於這些慢性疾病的慢性治療。

And the fact that in the absence of having non-steroidals, steroids were trying to fill that gap even though they're not really well suited for chronic management of the diseases.

事實上，在沒有非類固醇藥物的情況下，類固醇藥物試圖填補這一空白，儘管它們並不十分適合疾病的慢性治療。

So I think this idea of having a steroid step through, isn't really such a hurdle for patients for the reasons that Frank just said, which is that oftentimes when patients come in, they may get a steroid before it's realized that they're really going to have a need for a long-term management of the condition.

因此，我認為使用類固醇這一方法對患者來說並不是什麼障礙，原因正如弗蘭克剛才所說，即患者往往在入院時，可能會在意識到自己確實需要長期治療之前就使用類固醇。

And that's the appropriate time, anyway, from a medical management perspective to shift them over to a non-steroidal product like ZYROVE. They will be able to kind of carry them the distance from there. So I don't really see that the utilization management criteria are too out of sync with clinical practice and how it's evolving right now.

無論如何，從醫療管理的角度來看，現在是轉向使用 ZYROVE 等非類固醇產品的適當時機。他們將能夠從那裡運送這些物品到很遠的地方。因此，我並不認為利用管理標準與臨床實務以及目前的發展有太大的脫節。

Great. That's very helpful. Thank you.

偉大的。這非常有幫助。謝謝。

Thank you. And I said there are no further questions in the queue at this time. I will turn the call back over to Mr. Frank Watanabe for any closing remarks.

謝謝。我說現在沒有其他問題了。我將把電話轉回給 Frank Watanabe 先生，請他做最後發言。

Okay. Well, I think we've covered everything. I just want to thank everyone again for making the time to call in for the earnings call. And we look forward to talking to you all again in the not-too-distant future when we have Q1 results. Thanks a lot.

好的。好吧，我想我們已經討論完了所有內容。我只想再次感謝大家抽出時間參加收益電話會議。我們期待在不久的將來獲得第一季業績後再次與大家交談。多謝。

Just going to end today's conference call. Thank you for your participation and you may not disconnect.

今天的電話會議就此結束。感謝您的參與，您不能斷開連線。