Arcutis Biotherapeutics Inc (ARQT) 2024 Q1 法說會逐字稿

Good day and welcome to Arcutis Biotherapeutics 2024 first-quarter financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

美好的一天，歡迎參加 Arcutis Biotherapeutics 2024 年第一季財務業績電話會議。（操作員指示）請注意，今天的會議正在錄製中。

I would now like to hand the call over to Latha Vairavan, Vice President of Finance and Investor Relations. Please go ahead.

我現在想將電話轉交給財務和投資者關係副總裁 Latha Vairavan。請繼續。

Thank you. Good afternoon, everyone, and thank you for joining us today to review our first-quarter 2024 financial results and business update. Slides for today's call are available on the investors section of the Arcutis website.

謝謝。大家下午好，感謝您今天加入我們回顧我們 2024 年第一季的財務表現和業務更新。今天電話會議的幻燈片可在 Arcutis 網站的投資者部分查看。

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.

今天參加電話會議的是總裁兼執行長 Frank Watanabe；派崔克‧伯內特，首席醫療官；托德·愛德華茲，首席商務官；財務長戴維‧托珀 (David Topper)。

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

我想提醒大家，我們將在這次電話會議中做出前瞻性聲明。這些陳述存在一定的風險和不確定性，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，包括對我們業務和風險因素的描述。

With that, let me hand the call over to Frank.

現在，讓我把電話轉給弗蘭克。

Thanks, Latha, and thank you all for joining us today. You all know the other executives on the call, but I'm really excited today to welcome David Topper, our new Chief Financial Officer.

謝謝拉莎，也謝謝大家今天加入我們。你們都認識其他參加電話會議的主管，但我今天非常高興歡迎我們新任財務長 David Topper。

Well, David is new to his executive position here at Arcutis. He has been an adviser to us for more than four years. I expect many of you are already familiar with David and his exceptional experience and track record in the financial and biopharma world, and we could not be more pleased that he's decided to join us at this exciting time at Arcutis.

大衛是 Arcutis 的新高階主管。他擔任我們的顧問已有四年多了。我想你們中的許多人已經熟悉 David 以及他在金融和生物製藥領域的非凡經驗和業績記錄，我們非常高興他決定在 Arcutis 的這個激動人心的時刻加入我們。

As David joins us, I would also like to express my and the entire organization's thanks and gratitude to John Smither for his incredible service to Arcutis over the past five years. He served as our first CFO, guiding us through a successful initial public offering and has brought an incredible depth and breadth of both financial acumen and dermatology experience from his 25-plus-year career in the pharmaceutical industry. His contribution to the success of Arcutis at a critical time cannot be overstated, and we wish him well in his future endeavors and family time.

在 David 加入我們之際，我也想向 John Smither 表達我和整個組織的謝意和謝意，感謝他在過去五年中為 Arcutis 提供的出色服務。他擔任我們的第一位首席財務官，指導我們成功完成首次公開募股，並從他25 年多的製藥行業職業生涯中帶來了令人難以置信的深度和廣度的財務敏銳度和皮膚病學經驗。他在關鍵時刻對 Arcutis 的成功做出的貢獻怎麼強調都不為過，我們祝福他在未來的事業和家庭時光一切順利。

So with that, let me turn to slide 5 of the deck. We sustained our strong performance since our last earnings call, and I remain delighted with the Arcutis team and our execution during this quarter, and I'm thrilled about the momentum we are building towards a successful 2024.

那麼，讓我轉向投影片 5。自上次財報電話會議以來，我們保持了強勁的業績，我對 Arcutis 團隊和我們在本季度的執行情況仍然感到高興，我對我們為 2024 年取得成功而建立的勢頭感到興奮。

Once again, we saw strong growth during the quarter in our expanding ZORVYE portfolio as health care providers and their patients see how ZORVYE cream and ZORVYE foam address real needs in the treatment of psoriasis and seborrheic dermatitis, respectively.

隨著醫療保健提供者及其患者看到 ZORVYE 霜和 ZORVYE 泡沫如何分別滿足治療牛皮癬和脂漏性皮膚炎的實際需求，我們再次看到我們不斷擴大的 ZORVYE 產品組合在本季度出現強勁增長。

Solid growth in prescriptions for both the cream and the foam, coupled with additional gross-to-net improvements during the quarter, drove strong revenue growth in the first quarter, both versus Q4 and year over year with net revenues of $21.6 million, 70% of which was for the cream and 30% for the foam, which is still very early in the stages of launch.

乳霜和泡沫處方的穩健增長，加上本季總淨值的進一步改善，推動第一季收入強勁增長，與第四季度相比和同比均實現強勁增長，淨收入為 2160 萬美元，增長 70%其中乳霜佔30%，泡沫佔30%，目前仍處於發布的早期階段。

We've now generated more than 255,000 prescriptions for the cream and the foam combined from over 12,500 unique prescribers to date as our product delivers positive clinical experiences for HCPs and their patients.

到目前為止，我們已經從超過 12,500 名獨特的處方者那裡產生了超過 255,000 個乳膏和泡沫處方，因為我們的產品為 HCP 及其患者提供了積極的臨床體驗。

Our progress in improving GTN this past quarter, resulting in a blended GTN in the low 60%s across both products for the first quarter is particularly noteworthy, given the typical co-pay resets every product experiences in Q1 each year, in addition to the fact that we launched a new product during the quarter. Todd will provide some more color about how we achieved this remarkable accomplishment in just a few minutes.

上個季度我們在改進 GTN 方面取得的進展尤其值得注意，因為除事實上，我們在本季度推出了一款新產品。托德將在短短幾分鐘內提供更多關於我們如何實現這一非凡成就的資訊。

We also continue to successfully execute against our clinical and regulatory milestones, about which Patrick will go into more detail. Most important is the upcoming FDA PDUFA target date of July 7 for our sNDA for atopic dermatitis.

我們也繼續成功執行我們的臨床和監管里程碑，帕特里克將對此進行更詳細的介紹。最重要的是即將到來的 FDA PDUFA 目標日期，也就是我們針對異位性皮膚炎的 sNDA 的 7 月 7 日。

We also continue to progress our pipeline programs, in particular ARQ-234 for AD and ARQ-255 for alopecia areata. In February, we completed a secondary offering that raised $172 million gross proceeds, which along with net product revenues and our existing balance sheet puts us in a very strong financial position to sustain our investments in the ongoing launches in plaque psoriasis and Seb Derm, as well as the potential atopic dermatitis launch later this year while advancing our pipeline.

我們也繼續推進我們的管道項目，特別是用於 AD 的 ARQ-234 和用於斑禿的 ARQ-255。2 月份，我們完成了二次發行，籌集了1.72 億美元的總收益，加上淨產品收入和我們現有的資產負債表，使我們處於非常強大的財務狀況，以維持我們對斑塊牛皮癬和Seb Derm 正在進行的推出的投資，因為以及今年稍後可能推出的異位性皮膚炎產品，同時推進我們的產品線。

Also in February, we entered into a licensing agreement with Sato Pharmaceutical company, which grant Sato to an exclusive license for topical roflumilast for Japan. Arcutis received upfront payments of $20 million in the quarter, $25 million from Japan, with potential additional Japan milestones up to $40 million, as well as low double-digit to mid-teen double-digit percentage royalties. We also received $3 million from Huadong for our China partnership.

同樣在二月份，我們與佐藤製藥公司簽訂了許可協議，授予佐藤製藥在日本的外用羅氟司特獨家許可。Arcutis 在本季收到了 2,000 萬美元的預付款，其中 2,500 萬美元來自日本，潛在的日本里程碑高達 4,000 萬美元，以及低兩位數到中兩位數百分比的特許權使用費。我們還從華東獲得了 300 萬美元用於我們在中國的合作夥伴關係。

Moving on to slide 6. As we've mentioned on prior calls, a major reason why we're so excited for this year is that we are in the midst of a very significant expansion in the opportunity for topical roflumilast, which we expect will translate into substantial acceleration of our revenue trajectory. From the initial approval for psoriasis, the total addressable market for ZORYVE could grow tenfold from the end of 2023 to over 15 million patients in the United States.

繼續看投影片 6。正如我們在之前的電話會議中提到的，我們今年如此興奮的一個主要原因是，我們正在大力擴大外用羅氟司特的機會，我們預計這將轉化為我們的業務的大幅加速。從最初批准治療牛皮癬開始，到 2023 年底，ZORYVE 的潛在市場總量可能會增長十倍，在美國患者數量將超過 1500 萬。

I would add, that we are feeling increasingly bullish about our ability to begin gaining Medicare and Medicaid coverage this year. And we are making steady progress on a partnership in primary care. As our results this quarter reaffirm, we have the right commercial team in place for success, and we have an excellent plan to execute against these opportunities.

我想補充一點，我們對今年開始獲得醫療保險和醫療補助覆蓋的能力越來越樂觀。我們在初級保健領域的合作夥伴關係方面正在穩步取得進展。正如我們本季的業績所證實的那樣，我們擁有合適的商業團隊來取得成功，並且我們有一個出色的計劃來執行這些機會。

With that, let me turn it over to Todd to provide some further commentary around ZORYVE cream and foam launches in psoriasis and Seb Derm.

說到這裡，讓我把它交給 Todd，對 ZORYVE 霜和泡沫在牛皮癬和 Seb Derm 中的推出提供一些進一步的評論。

Thank you, Frank, and I'm extremely enthusiastic about the expansion of our commercial portfolio, HCP and patient response to bolster the products and the immense opportunities that lie ahead.

謝謝弗蘭克，我對擴大我們的商業產品組合、HCP 和患者反應非常熱衷，以支持產品和未來的巨大機會。

Moving to slide 8. The psoriasis TRx performance is continuing to show strength and these results demonstrate that we can push the trajectory in psoriasis. These efforts also lay a solid foundation for the brand and the building of a portfolio. Anyone search changes and deductible resets typically create a dip in prescription trends in the first week of the year.

轉到投影片 8。銀屑病 TRx 的表現繼續顯示出實力，這些結果表明我們可以推動銀屑病的發展軌跡。這些努力也為品牌和產品組合的建立奠定了堅實的基礎。任何搜尋變化和免賠額重置的人通常都會在一年的第一周導致處方趨勢下降。

As you can see, the TRx trend has rebounded from that. Further, it is notable that many patients push refills at the end of the year in anticipation of insurance disruption. So to see the growth in Q1 of 8% over Q4, 120% growth compared to first quarter 2023 highlights and encouraging trend line for ZORYVE cream. I'm now on slide 9. We continue to hear of a growing preference further even relative to other non-steroidal competitors.

正如您所看到的，TRx 趨勢已從中反彈。此外，值得注意的是，許多患者因預計保險中斷而在年底推動續保。因此，第一季較第四季成長 8%，較 2023 年第一季成長 120%，凸顯了 ZORYVE 霜的令人鼓舞的趨勢線。我現在在幻燈片 9 上。我們不斷聽說，相對於其他非類固醇競爭對手，人們對它的偏好也越來越高。

The value propositions retreat resonate with prescribers and aim to resolve plaque that can affect many different parts of the body, hard-to-treat areas like elbows and knees, but also the sensitive areas like the face, growing and under arms. The elements of efficacy, speed of response, the tolerability profile and the preservation of the skin barrier are becoming well recognized by dermatologists as differentiating factors.

這些價值主張引起了處方醫生的共鳴，旨在解決可能影響身體許多不同部位的斑塊，包括肘部和膝蓋等難以治療的區域，以及面部、生長區和腋下等敏感區域。功效、反應速度、耐受性和皮膚屏障的保護等要素正被皮膚科醫生廣泛認為是差異化因素。

Moving to slide 10. As a reminder, the ZORYVE was approved for Seb Derm patients in mid-December 2023, with a commercial launch in late January 2024. As read, seborrheic launch is off to a phenomenal start with over with over 46,000 TRx's in less than three months. In the beginning, we anticipated a large psoriasis patients either waiting the foam.

轉到投影片 10。需要提醒的是，ZORYVE 於 2023 年 12 月中旬獲準用於 Seb Derm 患者，並於 2024 年 1 月下旬上市。如所讀，脂溢性產品的推出取得了驚人的開端，在不到三個月的時間內就推出了超過 46,000 個 TRx。一開始，我們預計會有大量牛皮癬患者等待泡沫。

To quickly receive the prescription after approval. As we have pointed out before, seborrheic has been a space with a large unmet need without any innovation in the past 20 years. We anticipate the growth trajectory of the foam will likely moderate in the future. But with continued growth, we expect this growth trend to be well along to the large Seb Derm market with over 4.4 million prescription treated patients in the US Derm office and no other competitive treatment options.

批准後快速收到處方。正如我們之前指出的，在過去 20 年裡，脂溢性一直是一個有大量未滿足需求且沒有任何創新的領域。我們預計未來泡沫的成長軌跡可能會放緩。但隨著持續成長，我們預計這種成長趨勢將與龐大的 Seb Derm 市場一致，該市場在美國 Derm 辦公室有超過 440 萬名處方治療患者，並且沒有其他競爭性治療選擇。

On the right side of this slide, you can see the products that patients starting on foam are switched from. As expected, 80% are from topical steroids, but antifungals and there is a small portion of patients being switched from ZORYVE cream to foam.

在這張投影片的右側，您可以看到開始使用泡棉的患者所更換的產品。如預期，80% 的患者使用外用類固醇，但使用抗真菌藥物，還有一小部分患者從 ZORYVE 乳膏改用泡沫。

Moving on to slide 11, as we have shared previously, the dermatology prescriber base for PsO and Seb Derm are well lined. ZORYVE cream has already been used by most prescribers, we target and so far 40% of the ZORYVE cream writers have also written the foam after only three months. This highlights the potential for growth as we continue to convert existing cream writers to also writing foam and for foam further opens new interest is refrain for targets from not previously prescribed the cream.

繼續看投影片 11，正如我們之前分享的，PsO 和 Seb Derm 的皮膚科處方者基礎已經很豐富了。ZORYVE 霜已被大多數處方者使用，我們的目標是，到目前為止，40% 的 ZORYVE 霜作者也僅在三個月後就開出了泡沫。這凸顯了成長的潛力，因為我們繼續將現有的奶油書寫器轉變為書寫泡沫，並且泡沫進一步開啟了新的興趣，即避免以前未指定奶油的目標。

Now on slide 12. Clinician feedback about the ZORYVE foam has been extremely positive. These quotes from actual community dermatologists are typical of the comments we continue to hear about the unmet need for patients whose only option for decades have been steroids and antifungals. Likewise, the happiness of the patient when they experience relief in a more efficient and convenient manner. And for the dermatology practices, a smooth coverage experienced that enables ongoing usage.

現在在投影片 12 上。臨床醫生對 ZORYVE 泡沫的回饋非常積極。這些來自社區皮膚科醫生的引述是我們不斷聽到的關於患者需求未被滿足的典型評論，幾十年來，患者的唯一選擇是類固醇和抗真菌藥物。同樣，當患者以更有效、更方便的方式體驗緩解時，他們也會感到幸福。對於皮膚科實踐，平滑的覆蓋體驗可以持續使用。

Moving to slide 13. We were able to obtain coverage for ZORYVE foam from all three large PBMs very quickly. We are now working to secure the downstream plans. We expect home coverage to quickly catch up to that scene with the cream. We look at the percent of prescriptions being covered by insurers. We see an encouraging trend in ZORYVE cream was roughly three out of four [Rxs] are now covered by insurance.

轉到投影片 13。我們能夠非常快速地從所有三個大型 PBM 中獲得 ZORYVE 泡沫的覆蓋範圍。我們現在正在努力確保下游計劃。我們預計家庭覆蓋將很快趕上奶油場景。我們查看保險公司承保的處方藥百分比。我們看到 ZORYVE 霜的一個令人鼓舞的趨勢是大約四分之三的 [Rxs] 現在已納入保險範圍。

And for foam, slightly more than half of scripts are already covered by insurance. This is very positive considering we are still early in the launch. I would add that we expect the contribution to revenue growth coming from further gross-to-net improvements will likely moderate in coming quarters as we inch closer to our expected steady-state gross to net in the 50s.

對於泡沫來說，略多於一半的腳本已經有保險承保。考慮到我們仍處於發布初期，這是非常積極的。我想補充一點，隨著我們逐漸接近 50 年代預期的穩態總淨值，我們預計未來幾季毛淨值將進一步改善對營收成長的貢獻可能會減弱。

Going forward, most revenue growth will likely come from prescription demand growth in psoriasis, Seb Derm and if approved, atopic dermatitis. As Frank mentioned earlier, we were quite pleased that we were able to improve our gross-to-net in Q1, unlike what is typically seen due to co-pay resets and insurance change.

展望未來，大部分收入成長可能來自牛皮癬、Seb Derm 以及異位性皮膚炎（如果獲得批准）的處方需求成長。正如弗蘭克之前提到的，我們非常高興能夠在第一季提高毛淨值，這與通常因自付費用重置和保險變更而出現的情況不同。

As a part of our continued effort to optimize product access, we have implemented a program at our contracted pharmacy partners to support our commercially insured patients for whom our product is not covered by their insurance. With the new program, we are now directly providing these pharmacies with a unit for each non-covered unit of pharmacy dispenses. This unburden the high expense of not covered units resulting in improvement in our gross-to-net enables and ensures that patients have seamless access to our products.

作為我們不斷優化產品取得的努力的一部分，我們在簽約藥局合作夥伴實施了一項計劃，以支持我們的產品不在其保險範圍內的商業保險患者。透過新計劃，我們現在直接為這些藥房提供每個非承保單位的藥房配藥單位。這減輕了未承保單位的高額費用，從而改善了我們的毛淨值，使患者能夠無縫地使用我們的產品。

Now on slide 14. With a ZORYVE foam launch and approaching an anticipated approval in mild to moderate atopic dermatitis, we are creating a portfolio of options for dermatologists that will sustain the brand growth. The benefits of is there a portfolio of products that will address three different dermatology diseases with the current standard of care is topical steroids is unprecedented and creates simplicity for the dermatology, prescriber and patient management.

現在在投影片 14 上。隨著 ZORYVE 泡沫的推出以及治療輕度至中度異位性皮膚炎的預期即將獲得批准，我們正在為皮膚科醫生創建一系列選擇，以維持品牌的成長。外用類固醇的好處是，有一系列產品可以在當前的護理標準下解決三種不同的皮膚科疾病，這是前所未有的，並且為皮膚科、處方者和患者管理創造了簡單性。

The common clinical attributes of as I read across all indications will make prescribing simpler and when paired with the common market access co-pay card in an efficient and predictable fulfillment pathway, further simplifies dermatology practice operations as well. We are well on our way to becoming the preferred topical brand in dermatology. Turning it over to you, Patrick.

正如我所讀到的所有適應症的共同臨床屬性將使處方更加簡單，並且當與共同市場准入共同支付卡以高效且可預測的履行途徑配合使用時，也進一步簡化了皮膚科實踐操作。我們正在努力成為皮膚科首選的局部品牌。交給你了，派崔克。

Thank you, Todd. I'm now on slide 16. I'm extremely proud of the team's performance in delivering on the promise of topical roflumilast to the dermatology community in the clinic and hitting all of our timelines with regard to regulatory milestones. HCP excitement around the ZORYVE cream for atopic dermatitis continues to grow as we release more data and based on their own clinical experience with ZORYVE in psoriasis and Seb Derm.

謝謝你，托德。我現在在幻燈片 16 上。我對團隊的表現感到非常自豪，他們在臨床上兌現了局部羅氟司特對皮膚病學界的承諾，並達到了我們在監管里程碑方面的所有時間表。隨著我們發布更多數據並基於他們自己使用 ZORYVE 治療牛皮癬和 Seb Derm 的臨床經驗，HCP 對用於治療異位性皮膚炎的 ZORYVE 霜的興奮持續增長。

They finds ZORYVE product profile to be well suited to what they in their atopic dermatitis patients are looking for. Our PDUFA from mild to moderate AD down to the age of six is coming up quickly on July 7. Moving on to the approval of foam for Seb Derm. Here again, we're looking for some great feedback from dermatology providers.

他們發現 ZORYVE 產品簡介非常適合他們對異位性皮膚炎患者的需求。我們的 PDUFA 從輕度到中度 AD 到六歲的範圍很快就會在 7 月 7 日到來。接下來是 Seb Derm 泡沫的批准。在這裡，我們再次尋求皮膚科提供者的一些很好的回饋。

Unprecedented efficacy with a once-a-day foam in a market is the biggest psoriasis with no innovation in decades and no branded competition. Todd, Frank and I were recently out meeting with community dermatologists and the feedback on ZORYVE foam for their Seb Derm patients was very strong. We're also looking already looking to expand the indications for ZORYVE foam expecting to file another sNDA with the FDA in scalp and body psoriasis in the third quarter of 2024.

每天一次的泡沫在市場上前所未有的功效是幾十年來沒有創新、沒有品牌競爭的最大牛皮癬。托德、弗蘭克和我最近與社區皮膚科醫生會面，他們的 Seb Derm 患者對 ZORYVE 泡沫的反饋非常強烈。我們也正在尋求擴大 ZORYVE 泡沫的適應症，預計於 2024 年第三季向 FDA 提交另一份頭皮和身體牛皮癬的 sNDA。

Looking now on slide 17, some of the INTEGUMENT-PED data that we presented at the AAD meeting in March. As a reminder, this trial was conducted in mild to moderate AD patients ages two to five years old. Here, we're showing a side-by-side comparison of EASI 75. So that's the proportion of subjects who AD improved by 75% compared to baseline and WI-NRS success, that's Worst Itch Numeric Rating Scale which is an improvement of at least four points on the Worst Itch Numeric Rating Scale.

現在看投影片 17，我們在 3 月的 AAD 會議上展示了一些 INTEGUMENT-PED 數據。提醒一下，這項試驗是在 2 至 5 歲的輕度至中度 AD 患者中進行的。在這裡，我們展示了 EASI 75 的並排比較。因此，與基線和 WI-NRS 成功相比，AD 改善了 75% 的受試者比例，即最嚴重搔癢數值評估量表，比最嚴重搔癢數值評估量表至少提高了 4 分。

In both of these endpoints, we can see a rapid response already at week one with 19% of patients reaching EASI 75. And that number doubling by week four when we're coming in just under 40% of patients with a 75% improvement. On the right side, we have WI-NRS with a similar pattern of response for the Itch. That's the major symptom reported in AD patients and a significant driver of impact on quality of life.

在這兩個終點中，我們可以看到第一週就出現了快速反應，19% 的患者達到 EASI 75。到了第四周，這個數字就翻了一番，當時我們有不到 40% 的患者病情改善了 75%。在右側，我們有 WI-NRS，其對癢的反應模式類似。這是 AD 患者報告的主要症狀，也是影響生活品質的重要驅動因素。

With WI-NRS response, we jump out to 15% responders at week one over quarter, responding at week two and then continued to increase through week four at 35%. Turning to slide 18, I want to highlight the consistency of our data across different age groups. With our INTEGUMENT-PED data in two to five year olds on the left, and the POOLED data from ages six and above and INTEGUMENT 1 and INTEGUMENT 2 on the right.

透過 WI-NRS 響應，我們在第一周躍升至 15%，在第二週響應，然後在第四週繼續增加至 35%。轉向投影片 18，我想強調不同年齡層數據的一致性。左邊是 2 至 5 歲兒童的 INTEGUMENT-PED 數據，右邊是 6 歲及以上兒童的 POOLED 數據以及 INTEGUMENT 1 和 INTEGUMENT 2。

And all of these studies in just four weeks, we are getting about 40% of subjects to an EASI 75 and just shy of 35% of patients demonstrating a clinically meaningful improvement in Itch very consistent across the different age groups and ensuring that both the signs and symptoms of AD improve quickly. These data paired with our INTEGUMENT-OLE data, we presented previously round out the profile of ZORYVE where patients respond quickly and then continue to improve over time with long-term treatment when we extend treatment up to 52 weeks in our INTEGUMENT-OLE trial.

所有這些研究僅用了四個星期，我們就讓大約40% 的受試者達到了EASI 75，接近35% 的患者表現出臨床上有意義的瘙癢改善，在不同年齡組中非常一致，並確保這兩個跡象AD 症狀改善很快。這些數據與我們的INTEGUMENT-OLE 數據相結合，我們之前介紹了ZORYVE 的概況，其中患者反應迅速，然後當我們在INTEGUMENT-OLE 試驗中將治療延長至52 週時，隨著時間的推移，通過長期治療繼續改善。

On slide 19 now, I want to touch briefly on some new data in February seborrheic dermatitis coming out of the collaborative research project with Emma Guttman and Benji Ungar at Mount Sinai in New York. The team at Mount Sinai was able to using noninvasive tape-stripping technique to do gene expression profiling of patients with Seb Derm to provide us with the first real look at the path of physiology of this disease.

現在，在第 19 張投影片上，我想簡單介紹一下 2 月脂漏性皮膚炎的一些新數據，這些數據來自與 Emma Guttman 和 Benji Ungar 在紐約西奈山的合作研究計畫。西奈山的團隊能夠使用非侵入性膠帶剝離技術對 Seb Derm 患者進行基因表現譜分析，為我們提供了第一次真正了解這種疾病的生理學路徑。

The study firmly establishes Seb Derm as a unique disease distinct from psoriasis and atopic dermatitis, which is driven primarily by Th1, and Th17 Th22 inflammation. Otherwise the skin barrier defect specific alterations are clearly distinct from atopic dermatitis disease Seb Derm does not show any of the Th2 dysregulation, that's the hallmark of atopic dermatitis.

研究證實 Seb Derm 是一種不同於牛皮癬和異位性皮膚炎的獨特疾病，後者主要由 Th1 和 Th17 Th22 發炎驅動。否則，皮膚屏障缺陷的特異性改變與異位性皮膚炎疾病明顯不同。

I'm really proud of the Arcutis contribution to this effort, and I think it highlights the scientific benefits to the field when new therapeutic option is developed for an indication. This is similar to how the IL17 and IL23 dependency of psoriasis was defined by new therapeutics and similarly for IL4 and IL13 in atopic dermatitis. I think these new data also paint a very clear picture of why ZORYVE as a highly potent PDE4 inhibitor formulated in skin friendly formulation is so well suited for the treatment of Seb Derm. We know that many of the pathways identified here are modulated by PDE4.

我對 Arcutis 對這項工作的貢獻感到非常自豪，我認為它突顯了當針對適應症開發新的治療選擇時對該領域的科學益處。這與新療法定義乾癬的 IL17 和 IL23 依賴性相似，也類似於異位性皮膚炎中的 IL4 和 IL13 依賴性。我認為這些新數據也非常清楚地說明了為什麼 ZORYVE 作為一種以皮膚友好配方配製的高效 PDE4 抑制劑非常適合治療 Seb Derm。我們知道，此處確定的許多途徑均受 PDE4 調節。

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

這樣，我會把它交給大衛。

Thanks, Patrick. I first wanted to say how thrilled I am to be at Arcutis and working with this team. It's certainly an exciting quarter to be joining the company. I'm on slide 21. As you've heard by now, we achieved $21.6 million in net product revenues for ZORYVE for the first quarter of 2024, reflecting a 59% growth over Q4.

謝謝，派崔克。我首先想說的是，我很高興能夠加入 Arcutis 並與這個團隊一起工作。加入公司無疑是一個令人興奮的季度。我在投影片 21 上。正如您現在所聽說的，我們 ZORYVE 2024 年第一季的產品淨收入為 2,160 萬美元，比第四季成長 59%。

This was driven by substantial gross to net percentage improvement down to the low 60%s. The team's success in pulling through cover prescriptions and our processing of non-covered scripts through our preferred pharmacies. We also saw healthy prescription growth in the quarter. For the remainder of 2024, we expect continued prescription growth and some further gross to net improvement for both cream and foam.

這是由於毛淨百分比大幅下降至 60% 的低水平所推動的。團隊成功地透過我們的首選藥局取得承保處方以及我們對非承保處方的處理。本季我們也看到處方藥的健康成長。在 2024 年剩餘時間內，我們預計乳霜和泡沫的處方量將持續成長，並且總淨值將進一步改善。

On slide 22, you can see the strong financial performance in the first quarter. Again, net revenues for the first quarter of $21.6 million, up 675% from Q1 of '23 and 59% from the previous quarter. R&D expenses for the first quarter were $23.8 million, which is down significantly from Q1 2023 due to continued decreases in the development cost of topical roflumilast, but flat as Q4 2023 due to slightly elevated at one-time costs for ARQ-234 as we continue to advance it to IND.

在投影片 22 上，您可以看到第一季強勁的財務表現。同樣，第一季的淨收入為 2,160 萬美元，比 23 年第一季成長 675%，比上一季成長 59%。第一季的研發費用為2,380 萬美元，由於外用羅氟司特的開發成本持續下降，較2023 年第一季大幅下降，但與2023 年第四季持平，因為隨著我們繼續研究，ARQ- 234 的一次性成本略有上升將其推進到 IND 階段。

Recall that R&D includes our research operations and medical affairs expenses. SG&A expenses were $54.8 million for the first quarter, higher both sequentially and versus the same period last year. As we continue to invest in both our current and future launches. I'd like to emphasize that the team has made concerted efforts to make appropriate adjustments to our operating expense profile and to be good stewards of the capital that our investors have entrusted us with.

回想一下，研發包括我們的研究業務和醫療事務費用。第一季的 SG&A 費用為 5,480 萬美元，環比和去年同期均有所上升。隨著我們繼續投資於當前和未來的發布。我想強調的是，我們的團隊齊心協力，對我們的營運費用狀況進行了適當的調整，並做好了投資者託付給我們的資本的管家。

As we transition from a pre-commercial company to a commercial stage business with additional assets and development. We are endeavoring to ensure that we invest appropriately in both our current and future launches to avoid any risk of disrupting the trajectory of our products are demonstrating.

隨著我們從預商業公司過渡到擁有額外資產和發展的商業階段企業。我們正在努力確保對當前和未來的發布進行適當的投資，以避免任何擾亂我們產品展示軌蹟的風險。

On our final slide 23, on the balance sheet. We had total cash and marketable securities of $404 million at the end of the quarter. As I mentioned on the previous slide, we believe our current capital, together with product revenues enable us to continue operating the business and invest sufficient capital in commercial launches.

在我們最後一張投影片 23 上的資產負債表上。截至本季末，我們的現金和有價證券總額為 4.04 億美元。正如我在上一張投影片中提到的，我們相信我們現有的資本以及產品收入使我們能夠繼續經營業務並在商業發布中投入足夠的資本。

As Frank mentioned, in addition to the equity raise in February, we executed an out-license deal in Japan, which brought an additional non-dilutive capital of $25 million. The combined money raise enabled us to successfully address the capital requirement covenant with our lender. We also received the $3 million milestone payment from our Chinese partner Huadong based on their progress in China.

正如 Frank 所提到的，除了 2 月的股權融資之外，我們還在日本執行了一項向外許可交易，這帶來了 2500 萬美元的額外非稀釋資本。合併後的資金籌集使我們能夠成功滿足與貸方的資本要求契約。基於中國合作夥伴華東在中國的進展，我們也收到了 300 萬美元的里程碑付款。

With that, I'll hand it back to Frank for some closing remarks, and then we'll open it up for Q&A.

這樣，我會將其交還給弗蘭克進行一些結束語，然後我們將打開它進行問答。

Thanks, David. Our intent and vision are to make a positive and meaningful impact on the lives of people afflicted with chronic dermatologic diseases with ZORYVE now launched in two indications and potentially adding the atopic dermatitis launch later this year. We are proud to be helping millions of medical dermatology patients allowing us to create additional shareholder value.

謝謝，大衛。我們的目的和願景是對患有慢性皮膚病的人們的生活產生積極而有意義的影響，ZORYVE 目前已推出兩種適應症，並可能在今年稍後推出異位性皮膚炎。我們很自豪能夠幫助數百萬醫學皮膚科患者，使我們能夠創造額外的股東價值。

We are confident that Q1 2024, it lays the foundation for our sustained growth for the rest of 2024 and beyond. And with that, we'll open it up for Q&A.

我們相信 2024 年第一季將為我們在 2024 年剩餘時間及以後的持續成長奠定基礎。接下來，我們將開放它進行問答。

(Operator Instructions)

（操作員說明）

Serge Belanger, Needham.

塞爾吉·貝蘭格，李約瑟。

Good afternoon, and congrats on the progress, and solid quarter. First one, I guess for Todd, regarding the expansion in Medicaid and Medicare coverage. Maybe you can just give us an update and where you expect to be by the end of the year or starting 2025. And then secondly, Frank, you previously talked about the relatively low risk of the label approval for AD in July. Then maybe just talk about the label you're expecting, if it will include some of the Itch data and be broad enough to cover the mild, moderate and severe disease? Thanks.

下午好，恭喜您取得的進展和紮實的季度表現。第一個，我想是托德，關於醫療補助和醫療保險覆蓋範圍的擴大。也許您可以向我們提供最新情況以及您預計在今年年底或從 2025 年開始的情況。其次，Frank，您之前談到 7 月 AD 標籤批准的風險相對較低。然後也許只是談談您期望的標籤，它是否包含一些癢數據並且足夠廣泛以涵蓋輕度、中度和重度疾病？謝謝。

Sure, Todd, you want to take that and then maybe, Patrick, actually, you're probably best positioned to answer the question around the label.

當然，托德，你想接受這個，然後也許，帕特里克，實際上，你可能最適合回答圍繞標籤的問題。

Yeah, fantastic, Frank. First, I'll touch off on Medicaid. We continue to make good progress with Medicaid and I'll give you an example, it's very recent. Just recently, we picked up coverage at Florida state Medicaid and not only did we pick up the coverage there, but relative to the step edits have been in place for ZORYVE cream and ZORYVE foam.

是的，太棒了，弗蘭克。首先，我要談談醫療補助。我們在醫療補助方面繼續取得良好進展，我舉個例子，這是最近發生的。就在最近，我們獲得了佛羅裡達州醫療補助的承保範圍，我們不僅獲得了那裡的承保範圍，而且還對 ZORYVE 霜和 ZORYVE 泡沫進行了相對應的步驟編輯。

A single step edit for ZORYVE cream through a steroid and for ZORYVE foam, a single step edit through either or a steroid or antifungals. So we see this as a very positive movement as we continue to garner access in Medicaid. And we continue to be able to do that as we roll through the back half of 2024. Relative specifically to Medicare Part D, we continue to have positive discussions with the Part D PBMs and expect that we will pick up some of those Part D plans in the back half of 2024.

透過類固醇對 ZORYVE 霜進行單步驟編輯，對 ZORYVE 泡沫透過類固醇或抗真菌劑進行單步編輯。因此，隨著我們繼續獲得醫療補助，我們認為這是一項非常積極的舉措。到 2024 年下半年，我們將繼續做到這一點。具體相對於 Medicare D 部分，我們繼續與 D 部分 PBM 進行積極討論，並預計我們將在 2024 年下半年採納其中一些 D 部分計劃。

And in addition to that, likely some other coverage in Part D that would likely be effective January 1, 2025. So we are making good progress on all fronts with Medicaid and Medicare.

除此之外，D 部分中的其他一些保險可能將於 2025 年 1 月 1 日生效。因此，我們在醫療補助和醫療保險的各個方面都取得了良好進展。

Yes, and I can take the question about the label. Obviously, we're in the middle of a review by the FDA for our atopic dermatitis data for ages six and above. But what I can say is that this is an expansion of our existing cream label. Obviously, at a different concentration that will be added to that cream label.

是的，我可以回答有關標籤的問題。顯然，FDA 正在審查我們六歲及以上兒童的異位性皮膚炎數據。但我可以說的是，這是我們現有奶油標籤的擴展。顯然，奶油標籤上會添加不同的濃度。

So our expectation with regard to what will be included is kind of similar to what our clinical trials were conducted in. I think that if you look at the psoriasis 0.3% cream label going to give you a pretty good idea of where we expect demand in atopic dermatitis. And notably, you asked about the Itch. The Itch data were included in that to cream data as it goes and understanding within the last couple of years of the importance of being able to communicate these kind of symptom data like Itch.

因此，我們對所包含內容的期望與我們進行的臨床試驗類似。我認為，如果您查看 0.3% 牛皮癬藥膏的標籤，您就能很好地了解我們對異位性皮膚炎的需求預期。值得注意的是，你問到了癢癢的問題。搔癢數據包含在其中，以奶油數據，並在過去幾年內了解能夠傳達此類症狀數據（如搔癢）的重要性。

And so they've been included in our earlier label and in some others as well. So I think that's a good direction for the FDA to be taking with topicals. So yeah, we're looking forward to getting the PDUFA coming up here in July and being able to speak with you at that point about what exactly our label will includes.

因此，它們已包含在我們早期的標籤和其他一些標籤中。所以我認為這是 FDA 在外用藥物方面採取的一個很好的方向。所以，是的，我們期待 PDUFA 於 7 月來到這裡，並能夠在那時與您討論我們的標籤到底包含哪些內容。

(Operator Instructions)

（操作員說明）

Seamus Fernandez, Guggenheim Securities.

謝默斯·費爾南德斯，古根漢證券公司。

Great. Thanks for the questions, and congrats on the quarterly results. Wanted to ask a couple of questions here. So first, Todd, great execution with the foam and moving forward from the gross to net and having that really be seamless. when we think about the atopic dermatitis opportunity can you help us understand how you expect that market to evolve, just given the growing comfort that physicians already have with Opzelura and where you see them in ZORYVE cream really standing out in the AD space specifically?

偉大的。感謝您的提問，並對季度業績表示祝賀。想在這裡問幾個問題。首先，托德，泡沫的出色執行力，從總體到淨值的進展，並且真正做到了無縫。當我們考慮到異位性皮膚炎機會時，考慮到醫生已經對 Opzelura 越來越滿意，以及您在 ZORYVE 霜中看到它們在 AD 領域真正脫穎而出，您能否幫助我們了解您期望該市場如何發展？

Second question is, Frank, I think we've talked about where the gross-to-net may be able to go sort of towards the end of this year and then hopefully maybe a steady-state gross to net at some point. Just hoping you could remind us where you see those numbers headed to overtime as the growth of the asset improves.

第二個問題是，弗蘭克，我想我們已經討論過今年年底毛淨比可能會達到什麼水平，然後希望在某個時候毛淨比達到穩定狀態。只是希望您能提醒我們，隨著資產成長的改善，您認為這些數字將在哪裡超時。

Maybe you can also help us understand that in context where you see pricing headed in that regard. Obviously, other folks can go very aggressive on price, but you've price hikes, you've taken a different strategy as it relates to sort of remaining comfortably within the subspecialty tier. So just interested to know how to think about price increases and then gross-to-net overtime? Thanks.

也許您也可以幫助我們了解您認為這方面的定價趨勢的背景。顯然，其他人可能會在價格上非常激進，但你提高了價格，你採取了不同的策略，因為這與在子專業級別中保持舒適有關。所以只是想知道如何考慮價格上漲以及毛淨加班費？謝謝。

Sure. Todd, you want to take the first question on AD?

當然。托德，你想回答關於 AD 的第一個問題嗎？

Yeah. I'll take the first question on AD and as I am I firmly believe that we have a significant opportunity in atopic dermatitis. First, relative to access -- I do anticipate that ZORYVE foam the PBMs and payers will treat ZORYVE cream in atopic dermatitis as a line extension, which will enable us to garner a quick access and quick improvements in our gross to net for atopic dermatitis.

是的。我將回答關於 AD 的第一個問題，我堅信我們在異位性皮膚炎方面有很大的機會。首先，相對於取得——我確實預計 ZORYVE 泡棉 PBM 和付款人會將 ZORYVE 霜治療異位性皮膚炎作為產品線延伸，這將使我們能夠快速獲得特應性皮膚炎的毛淨值并快速改善。

Furthermore, when you look across the ZORYVE portfolio, the feedback we receive from ZORYVE cream and ZORYVE foam relative to its uniquely formulated vehicle, which likewise will translate into atopic dermatitis as well as the tolerability as of the asset. Furthermore, if our label is similar to that of ZORYVE cream in psoriasis and ZORYVE foam.

此外，當您查看 ZORYVE 產品組合時，我們從 ZORYVE 霜和 ZORYVE 泡沫相對於其獨特配方的載體收到的反饋，這同樣會轉化為異位性皮膚炎以及資產的耐受性。此外，如果我們的標籤類似於ZORYVE牛皮癬霜和ZORYVE泡沫的標籤。

After approval is likely will have no limitations of use on location, body surface area, duration or concomitant use with immunosuppressants, which will be a strategic advantage for us within the market. In addition to that, being a once-a-day and topical likewise resonate with patients.

批准後可能不會限制使用部位、體表面積、持續時間或與免疫抑制劑合併使用，這將是我們在市場上的策略優勢。除此之外，每天一次的局部用藥也能引起患者的共鳴。

And then I will say one big strategic lever that we'll have with the addition and approval of a topic dermatitis business, a portfolio approach that we're having because you think three products that are distinct formulated across three significant dermatologic conditions that dermatologists are treating every day throughout the day and by having three formulations, the simplicity of prescribing and the ability to swiftly explain the treatment to their patients

然後我要說的是，隨著主題皮膚炎業務的增加和批准，我們將擁有一個重要的戰略槓桿，這是我們正在採用的一種組合方法，因為你認為三種產品的配方不同，針對皮膚科醫生的三種重要皮膚病狀況全天每天進行治療，採用三種配方，處方簡單，能夠快速向患者解釋治療方法

And on the back end, a very predictable fulfillment process across those three products, I think will really give us a better advantage in the market. So I think it's a great opportunity for us, and I look forward to that PDUFA date and the eventual launch in atopic dermatitis.

在後端，這三種產品的非常可預測的履行流程，我認為確實會為我們帶來更好的市場優勢。所以我認為這對我們來說是一個很好的機會，我期待著 PDUFA 的日期以及最終在異位性皮膚炎領域的推出。

Thanks, Todd. Yes, So Seamus, thanks for your question around gross to net as well. So let me break this down a little bit in terms of gross to net evolution. We continue to feel very good that we are going to get to a steady state, in the 50s. And I think the fact that we were able to get down to the low 60s during Q1 in spite of the annual resets and in spite of the fact that we launched a new drug.

謝謝，托德。是的，Seamus，也感謝您提出有關毛淨值的問題。因此，讓我從整體到淨演化的角度對此進行一些分解。我們仍然感覺非常好，我們將在 50 年代達到穩定狀態。我認為，儘管我們進行了年度重置，並且推出了一種新藥，但我們在第一季仍能夠將銷售額降至 60 多歲。

I think really speaks to our ability to get gross-to-nets down and I think it also speaks to the value of our overall pricing strategy. We would expect that we'll get to steady-state on the psoriasis cream by probably by the end of this year and we're getting very close already. The foams, probably going to be a little bit lagging behind that, just because it's a new product and we have to get downstream insurance coverage.

我認為這確實說明了我們降低毛淨值的能力，而且我認為這也說明了我們整體定價策略的價值。我們預計銀屑病霜的使用可能會在今年年底達到穩定狀態，而且我們已經非常接近了。泡沫可能會有點滯後，因為它是新產品，我們必須獲得下游保險。

But as Todd mentioned, already, we're already over 50% covered prescriptions for the foam and so we think that foam will catch up with 0.3% cream very quickly and then we'll have to go through the same sort of evolution when we launch atopic dermatitis. But again, I think what we've been able to achieve with the foam getting to over 50% coverage very quickly and not having really a meaningful negative impact on gross net with the foam launch, I think you would expect to see something very similar with atopic dermatitis.

但正如托德所提到的，我們已經覆蓋了超過 50% 的泡沫處方，因此我們認為泡沫將很快趕上 0.3% 的奶油，然後當我們使用泡沫時，我們將不得不經歷同樣的演變。異位性皮膚炎。但我再次強調，我們很快就透過泡沫覆蓋率達到 50% 以上，並且泡沫的推出沒有對總淨值產生真正有意義的負面影響，我認為您會期望看到非常類似的東西患有異位性皮膚炎。

Again, payers view this. These is line extensions that are covered by the existing contracts. And so that really facilitates and speeds up, frankly, our ability to get coverage. In terms of where prices headed, we did price differentially than other branded topicals when we launched. And that really got back primarily to a question of Medicare and Medicaid access and we were delighted with the recent Florida win that Todd just mentioned.

付款人再次看到了這一點。這些是現有合約涵蓋的產品線延伸。坦白說，這確實促進並加快了我們獲得保險的能力。就價格走向而言，我們推出時的定價與其他品牌主題有所不同。這實際上主要回到了醫療保險和醫療補助的問題，我們對托德剛才提到的最近佛羅裡達州的勝利感到高興。

I think that's another proof point that our pricing and access strategy is working, and we expect to have more proof throughout the year as we garner access through Medicaid and hopefully Medicare as Todd mentioned by the end of the year. In terms of our ability to price hike up, frankly, the contracts these days with all the PBMs limits any company's ability to price hikes. There are price protection clauses in there and we don't think that we are disadvantaged versus the other companies in that respect.

我認為這是我們的定價和准入策略正在發揮作用的另一個證據，隨著我們通過醫療補助計劃獲得准入機會，並希望在年底前通過托德提到的醫療保險獲得准入機會，我們預計全年都會有更多的證據。就我們提價的能力而言，坦白說，目前與所有 PBM 簽訂的合約限制了任何公司提價的能力。其中有價格保護條款，我們認為我們在這方面與其他公司相比並不處於劣勢。

The only thing that we do need to be mindful of is that Medicare, Medicaid specialty threshold, which all the other branded topicals are well above and we are actively trying to keep below and we have headroom there. So I would anticipate that in the future, there may be some price increases. We do have that ability. But I don't think that we're really impaired in our ability to take price increases in line with inflation any more than any other company is as long as we stay under that CMS threshold.

我們唯一需要注意的是醫療保險、醫療補助的專業門檻，所有其他品牌主題都遠高於該門檻，我們正在積極努力保持在以下水平，並且我們還有空間。所以我預計未來價格可能會有一些上漲。我們確實有這個能力。但我認為，只要我們保持在 CMS 閾值以下，我們根據通貨膨脹調整價格上漲的能力就不會比其他公司受到更大的損害。

Great. Then maybe just as one follow-up. As you think about that rapid uptake that we saw with regard to Seb Derm. How should we be thinking about atopic dermatitis, it seems like with product on market, there won't necessarily be that same level of pent-up demand, but perhaps this feels a little bit more likely on the sort of psoriasis uptake curve. Although again, when a lot of free drug was given away and the psoriasis curves, those were also accelerated to some degree.

偉大的。然後也許只是作為一項後續行動。當您想到我們看到的 Seb Derm 的快速普及時。我們應該如何考慮異位性皮膚炎，似乎市面上的產品不一定有同樣程度的被壓抑的需求，但也許在牛皮癬的吸收曲線上感覺更有可能。不過，當大量免費藥物被贈送時，牛皮癬曲線也在一定程度上加速了。

Although that's not the path that's Arcutis took. So just trying to get a better sense of how to think about the trajectory of the uptake curve for cream as atopic derm comes on?

儘管那不是Arcutis所走的路。那麼，只是想更了解如何考慮異位性皮膚出現時乳霜吸收曲線的軌跡嗎？

Yes, sure. I think it's a great question too, Seamus. I think that it would not be realistic to expect to see something and uptake comparable to Seb Derm for atopic dermatitis. As you mentioned, it has been 20 years since there's been any innovation in Seb Derm. And as Todd mentioned, we thought think that there was a pretty good size pool of ready patients just waiting for the ZORYVE foam to be approved.

是的，當然。我認為這也是一個很好的問題，Seamus。我認為期望看到與 Seb Derm 相媲美的治療異位性皮膚炎的藥物和吸收是不現實的。正如您所提到的，Seb Derm 已經有 20 年沒有任何創新了。正如托德所提到的，我們認為有相當多的準備就緒的患者正在等待 ZORYVE 泡沫獲得批准。

That really drove that very rapid uptake that we saw right out of the gate. So I wouldn't expect that kind of growth with AD out of the gate. On the other hand, I think compared to the psoriasis launch, I think that AD could outperform psoriasis for a number of reasons. One of them, I think Todd alluded to, which is -- when we launched ZORYVE in psoriasis, nobody really knows ZORYVE and they didn't really know our Arcutis all that well.

這確實推動了我們一開始就看到的非常快速的採用。所以我不希望 AD 出現這種增長。另一方面，我認為與牛皮癬的推出相比，我認為 AD 的表現可能優於牛皮癬，原因有很多。其中之一，我想 Todd 提到過，那就是——當我們推出 ZORYVE 治療牛皮癬時，沒有人真正了解 ZORYVE，而且他們也不太了解我們的 Arcutis。

By the time we launch in atopic dermatitis, pretty much all of the dermatologists will have used the cream and a high percentage will use the foam. So we're going to be launching with that positive tailwind of experience with the efficacy of the ZORYVE, the safety tolerability of ZORYVE. And also, as Todd mentioned, the ease of the process for getting patients fulfilled.

當我們推出異位性皮膚炎治療時，幾乎所有皮膚科醫生都會使用該霜，並且很大比例會使用泡沫。因此，我們將憑藉 ZORYVE 的功效、ZORYVE 的安全耐受性的正面經驗推出產品。而且，正如托德所提到的，讓患者滿意的過程很容易。

So I think that will aid the uptake in atopic dermatitis. It's a much more competitive market, so I wouldn't expect to have a large warehouse of patients just waiting when we launch the atopic dermatitis. So yes, I think the uptakes probably going to fall somewhere in between the last two launches.

所以我認為這將有助於異位性皮膚炎的吸收。這是一個競爭更加激烈的市場，所以我不認為當我們推出異位性皮膚炎時會有大量患者在等待。所以，是的，我認為使用量可能會落在最近兩次發布之間的某個位置。

Great. Thanks so much.

偉大的。非常感謝。

(Operator Instructions)

（操作員說明）

Vikram Purohit, Morgan Stanley.

維克拉姆‧普羅希特，摩根士丹利。

Hi, good afternoon. Thanks for taking our questions. So we have two, one on Seb Derm and then one on the potential AD launch. So for Seb Derm, understanding that it's still pretty early in the launch trajectory, what is your current sense on duration and the annual number of candidate product, a customer or patient rather might work through over the course of a year?

嗨，下午好。感謝您回答我們的問題。所以我們有兩個，一個是 Seb Derm，另一個是潛在的 AD 發布。因此，對於 Seb Derm 來說，了解它仍處於發布軌蹟的早期階段，您目前對候選產品、客戶或患者可能在一年內完成的持續時間和年度數量有何看法？

And then for AD, you previously mentioned entering a partnership to exit the primary care setting. So I just wanted to see how those discussions are going, what you currently see as the time line to establishing a partnership and what you would see as the, I guess, the ideal economics in terms of the collaboration here? Thank you.

對於AD，您之前提到建立合作夥伴關係以退出初級保健機構。所以我只是想看看這些討論進展如何，您目前認為建立合作夥伴關係的時間表是什麼，以及我想您認為這裡合作的理想經濟效益是什麼？謝謝。

Sure. So around duration and consumption I think it's very early still to be able to assess that. We are seeing some refills come through -- I don't actually have the latest numbers. Todd may have that but we are seeing some of it yet. But, you know, it's not a significant driver of growth just given how early we are in the launch. Seborrheic dermatitis covers less body surface area than psoriasis and atopic dermatitis. May be that patients consume fewer cans throughout the year.

當然。因此，關於持續時間和消耗，我認為現在評估還為時過早。我們看到一些補充品出現了——我實際上沒有最新的數字。托德可能有這樣的情況，但我們還沒有看到其中的一些。但是，您知道，考慮到我們的推出時間還很早，這並不是成長的重要推動力。脂漏性皮膚炎覆蓋的體表面積小於牛皮癬和異位性皮膚炎。可能是患者全年消耗的罐頭較少。

I think what we've previously stated was that we thought that was probably something like one to two cans a year for Seb Derm. We don't have anything at this point to revise that guidance. So I would say that we would expect that it to be something similar to that until we learn otherwise and we'll update you guys if we do get information on that.

我想我們之前說過的是，我們認為 Seb Derm 每年可能會喝一到兩罐。目前我們沒有任何內容可以修改該指南。所以我想說，我們希望它與此類似，直到我們了解到其他情況為止，如果我們確實獲得了相關信息，我們會向大家通報最新情況。

In terms of the atopic dermatitis partnership. What we have been saying all along is that we would like to have that done sometime around the launch. I don't think we need to have it done by the launch necessarily because you really have to win with the dermatologists first, the PCPs will be looking to the derms for an example.

在異位性皮膚炎夥伴關係方面。我們一直在說的是，我們希望在發布前後的某個時間完成這項工作。我認為我們不一定需要在發布前完成它，因為你確實必須先贏得皮膚科醫生的支持，PCP 將以皮膚科醫生為例。

And so I don't think it's critical necessarily being primary care right at the launch. But I think it's very likely that we'll have that deal done. We will have a deal done still this year. We're feeling very good about how the discussions been going with potential partners. Then in terms of economics, you know, it'll really come down to the negotiation with a potential partner.

因此，我認為在推出時提供初級保健不一定是至關重要的。但我認為我們很有可能完成這筆交易。今年我們仍將達成協議。我們對與潛在合作夥伴的討論進展感到非常滿意。然後就經濟而言，你知道，這實際上取決於與潛在合作夥伴的談判。

They will have obviously a considerable expense just given how large primary care sales forces are. But we've obviously invested a lot in the product. We do have a preference for some sort of a revenue-sharing arrangement rather than a fee for service because I think that that aligns the interests of the two partners, which is aligned with the interest of shareholders, right.

考慮到初級保健銷售人員的規模，他們顯然將承擔相當大的費用。但我們顯然在產品上投入了大量資金。我們確實更傾向於某種收入分享安排，而不是服務費，因為我認為這符合兩個合作夥伴的利益，也符合股東的利益，對吧。

As opposed to fee for service where maybe you get what you pay for. But we'll have to negotiate that with whoever ends up being the final choice of a partner and then we'll let investors know what the economics are around the deal.

與收取服務費相反，在服務費中，您可能會得到一分錢一分貨。但我們必須與最終選擇的合作夥伴進行談判，然後我們會讓投資者知道這筆交易的經濟效益。

Understood. Thank you.

明白了。謝謝。

(Operator Instructions)

（操作員說明）

Tyler Van Buren, TD Cowen.

泰勒·範布倫，TD·考恩。

Hey guys, good afternoon. Regarding the primary care partnership, is that something that you would like to happen soon? And what would it look like in how many additional patients do you believe you could reach via the strategy?

嘿夥計們，下午好。關於初級保健合作夥伴關係，您希望很快發生這種情況嗎？您認為透過該策略可以接觸到多少額外的患者？

Sure. First of all, has the presidential campaign going. So around for those of you who weren't at the conference -- that was an inside joke. On the PCP partnership, as I just said to the group, I think we'd like to have this done sometime around the launch, which is probably going to be in the August time frame. I feel very confident about our ability to get it done before the end of the year.

當然。首先，總統競選是否正在進行。對於那些沒有參加會議的人來說，這是一個內部笑話。關於 PCP 合作夥伴關係，正如我剛才對小組所說的那樣，我認為我們希望在發布前後的某個時間完成這項工作，這可能是在 8 月的時間範圍內。我對我們有能力在年底前完成它感到非常有信心。

So that's kind of I would put it as bookends. In terms of the opportunity size in about 50% of atopic dermatitis and about 50% of each of seborrheic dermatitis. Patients are treated outside of dermatology. They're not all in primary care or pediatrics, but a very large percentage of those patients are sitting in the PCP or pediatricians office, both Seb Derm and AD.

所以我會把它當作書擋。就機會大小而言，異位性皮膚炎約佔 50%，脂漏性皮膚炎約佔 50%。患者在皮膚科以外接受治療。他們並不全都在初級保健或兒科，但其中很大一部分患者坐在 PCP 或兒科醫生辦公室，包括 Seb Derm 和 AD。

More pediatricians for AD, more PCP for Seb Derm, just because the ages of some onset of the disease? So we're looking for a partner that has good coverage primarily of the PCP and the pediatric specialties. If they had coverage in allergy, that would probably be also a benefit, although that's a very small community, but it's a pretty sizable additional opportunity, but tapping into primary care and pediatrics just because that's where the patients are sitting.

更多的兒科醫生治療 AD，更多的 PCP 治療 Seb Derm，僅僅是因為某些疾病發病的年齡？因此，我們正在尋找一個主要覆蓋 PCP 和兒科專業的合作夥伴。如果他們有過敏保險，那可能也是一個好處，雖然這是一個非常小的社區，但這是一個相當大的額外機會，但利用初級保健和兒科只是因為那是病人坐的地方。

Okay, thank you.

好的謝謝。

(Operator Instructions)

（操作員說明）

Uy Ear, Mizuho.

Uy Ear，瑞穗。

Hi, guys. Congrats on the quarter on. My first question is, I think you said you're expecting gross-to-net to reach steady-state towards the end of the year. But you're going to have Medicaid and or more Medicare's coming online towards the end of the year as well.

嗨，大家好。恭喜本季。我的第一個問題是，我想您說過預計毛淨比將在今年年底達到穩定狀態。但醫療補助和/或更多醫療保險也將在今年年底上線。

Just are you kind of saying that the Medicare and Medicaid will not have an impact on gross-to-net to be in 2025 or like how should we sort of think about the interplay with Medicare and Medicaid in terms of gross-to-net? And secondly, could you perhaps elaborate on your new program, your distribution programs where I think you said that you were for every unit, the specialty pharma get one unit for uncovered patient? I didn't quite understand it. Thanks.

您只是說 Medicare 和 Medicaid 不會對 2025 年的毛淨值產生影響，或者我們應該如何考慮 Medicare 和 Medicaid 在毛淨值方面的相互作用？其次，您能否詳細說明您的新計劃，您的分配計劃，我認為您說過您為每個單位，專業製藥公司為未覆蓋的患者提供一個單位？我不太明白。謝謝。

Sure. Good to hear from you. I'll answer your first one and then Todd, I'll ask you to talk about them, the pharmacies. Yes. So I did say that we thought I think we will get to our steady-state or around our steady-state gross to net this year on the psoriasis book of business. And yes, it does factor in Medicare and Medicaid coverage.

當然。很高興聽到你的消息。我會回答你的第一個問題，然後托德，我會請你談談藥局。是的。所以我確實說過，我們認為今年的銀屑病業務淨額將達到穩態或接近穩態總收入。是的，它確實考慮了醫療保險和醫療補助覆蓋範圍。

Couple of things to keep in mind. One is Medicare, Medicaid is a less important contributor to the psoriasis business. Than it is SEB Derm and AD, just because of the demographics of the patient population is quite a bit smaller. But secondly, as we've said previously, we with our pricing and access strategy, we don't anticipate having to give outsized rebates for Medicare and Medicaid coverage.

有幾點要記住。一是醫療保險，醫療補助對牛皮癬業務的貢獻較小。它比SEB Derm和AD，只是因為患者人口的人口統計要小得多。但其次，正如我們之前所說，根據我們的定價和准入策略，我們預計不會為醫療保險和醫療補助保險提供巨額回扣。

And I think when you look at it all in the Medicare and Medicaid book of business is probably going to be similarly profitable to the commercial book of business. So we don't see -- we don't expect that to have a really meaningful negative impact on our gross-to-net. Todd, do you want to maybe talk about the pharmacies?

我認為，當你看看醫療保險和醫療補助業務帳簿中的所有內容時，它可能會與商業業務帳簿中獲得類似的利潤。因此，我們預計這不會對我們的毛淨值產生真正有意義的負面影響。托德，你想談談藥局的事嗎？

Yes, fantastic, I will. Just to mention the relative to improving our gross to net, we took a multipronged approach in the program that I'll talk about here in just a minute was only one lever that we pull to improve our gross to net. Specifically to that program, do you think about it prior to implementing the current program when a commercially insured non-covered ZORYVE prescription was dispensed from the pharmacy.

是的，太棒了，我會的。只是提一下相對於提高淨毛額而言，我們在該計劃中採取了多管齊下的方法，我將在一分鐘內討論這只是我們提高淨毛額的一個槓桿。具體到該計劃，在實施當前計劃之前，當您從藥房配發商業保險的非承保 ZORYVE 處方時，您是否考慮過這一點。

What happened is that prescription was process and then the cost of that unit was charged to our co-pay card. Then under the new current program, where non-covered prescription is dispensed by a contract that pharmacy then our Arcutis directly provides the pharmacy with a unit for every unit they used from their inventory to fill that non-covered script versus charged it to the co-pay card, which you're unburdened by the impact of a co-pay card and non-covered scripts are gross to net.

發生的情況是，處方正在處理中，然後該單位的費用從我們的自付卡中扣除。然後，根據目前的新計劃，非承保處方是透過藥房的合約進行配發的，然後我們的Arcutis 直接向藥房提供一個單位，用於他們從庫存中使用的每個單位來填充非承保處方，而不是向公司收取費用- 支付卡，您不會受到共同支付卡的影響，並且未覆蓋的腳本對淨值來說是很噁心的。

Okay, thanks.

好的謝謝。

Thank you, and I'm showing no further questions. I would now like to turn the call back to Frank for closing remarks.

謝謝你，我不會再問任何問題了。現在我想將電話轉回給弗蘭克，讓他發表結束語。

Okay. I'll be very brief as well. I really appreciate everyone calling in for the call today and the great questions we've had and we look forward to talking to you all in about another quarter. Thanks a lot. Bye.

好的。我也會非常簡短。我非常感謝今天撥打電話的每個人以及我們提出的重要問題，我們期待在下一個季度與大家交談。多謝。再見。

This concludes today's conference call and 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。