Arcutis Biotherapeutics Inc (ARQT) 2022 Q4 法說會逐字稿

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  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by, and welcome to Arcutis Biotherapeutics, Inc. Fourth Quarter 2022 Earnings Conference Call. (Operator Instructions) Please note that today's conference is being recorded.

    女士們,先生們,感謝您的支持,歡迎來到 Arcutis Biotherapeutics, Inc. 2022 年第四季度收益電話會議。 (操作員說明)請注意,今天的會議正在錄製中。

  • I will now hand the conference over to your speaker host, Eric McIntyre, Head of Investor Relations. Please go ahead.

    我現在將把會議交給您的演講主持人,投資者關係主管 Eric McIntyre。請繼續。

  • Eric McIntyre - Head of IR

    Eric McIntyre - Head of IR

  • Thank you, Olivia. Good afternoon, everyone, and thank you for joining Arcutis's fourth quarter and full year 2022 earnings call. Slides are available on the Investors section of our website.

    謝謝你,奧利維亞。大家下午好,感謝您參加 Arcutis 的第四季度和 2022 年全年財報電話會議。幻燈片可在我們網站的投資者部分獲取。

  • On today's call, we have Frank Watanabe, President and CEO; Scott Burrows, Chief Financial Officer; Ken Lock, Chief Commercial Officer; and Patrick Burnett, Chief Medical Officer. During this call, I'd remind everyone that we will be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. We encourage you to review the information disclosed in our latest SEC filings.

    在今天的電話會議上,我們有總裁兼首席執行官 Frank Watanabe; Scott Burrows,首席財務官;首席商務官 Ken Lock;和首席醫療官 Patrick Burnett。在這次電話會議中,我要提醒大家,我們將做出前瞻性陳述。這些陳述受某些風險和不確定因素的影響,我們的實際結果可能存在重大差異。我們鼓勵您查看我們最新提交給美國證券交易委員會的文件中披露的信息。

  • With that, I'll hand the call to Frank.

    有了這個,我會把電話交給弗蘭克。

  • Todd Franklin Watanabe - President, CEO & Director

    Todd Franklin Watanabe - President, CEO & Director

  • Thanks, Eric. So I'm on Slide 5 in the deck, which is on our website, if you folks haven't downloaded yet. So 2022 was really a year of exceptional execution for Arcutis and really set us up for great success in 2023 and beyond.

    謝謝,埃里克。如果你們還沒有下載的話,我在我們網站上的幻燈片 5 上。因此,2022 年對於 Arcutis 來說確實是執行力非凡的一年,並真正為我們在 2023 年及以後取得巨大成功做好了準備。

  • Just to recap, we had 4 successful pivotal Phase III trials read out. We had an on-time approval for ZORYVE in plaque psoriasis. We raised over $300 million to secure a strong balance sheet to support our continued commercialization and advancing of our pipeline, and we continue to progress in building our pipeline.

    回顧一下,我們讀出了 4 項成功的關鍵 III 期試驗。 ZORYVE 用於斑塊狀銀屑病的準時獲批。我們籌集了超過 3 億美元來確保強大的資產負債表,以支持我們繼續商業化和推進我們的管道,我們繼續在建設我們的管道方面取得進展。

  • On Slide 6, we're making steady progress towards our vision of building one of the biotechnologies leading dermatology companies, some highlights from Q4 and other recent developments.

    在幻燈片 6 上,我們正在穩步朝著建立生物技術領先的皮膚病學公司之一的願景邁進,第四季度的一些亮點和其他近期發展。

  • With ZORYVE, we've got an innovative product that's really well-positioned for a long-term success with clinically meaningful benefits over alternative treatments. We're seeing very encouraging script growth as physicians gain positive real-world experience with ZORYVE and we're also having great success in obtaining broad high-quality access. We're delighted today to announce that we've received coverage from the second of the 3 large major national PBMs effective tomorrow.

    借助 ZORYVE,我們獲得了一種創新產品,該產品非常適合長期成功,與替代療法相比具有臨床意義的益處。隨著醫生使用 ZORYVE 獲得積極的現實世界經驗,我們看到了非常令人鼓舞的腳本增長,並且我們在獲得廣泛的高質量訪問方面也取得了巨大成功。我們今天很高興地宣布,我們已經收到明天生效的三大主要國家 PBM 中的第二個的報導。

  • And Ken's going to comment a little bit more about the access situation, but we're really happy with our rapid [ph] prior and obtaining broad high-quality coverage for his REIT ph . We also continue to advance additional indications for topical roflumilast capitalizing on what is really turning into a unique pipeline in a product. We had the positive readouts from INTEGUMENT-1 and 2 in atopic dermatitis.

    Ken 將對訪問情況發表更多評論,但我們對我們的快速 [ph] 優先和獲得廣泛的高質量覆蓋他的 REIT ph 感到非常滿意。我們還繼續推進外用 roflumilast 的其他適應症,利用真正變成產品中獨特管道的東西。我們從 INTEGUMENT-1 和 2 中獲得了特應性皮炎的陽性讀數。

  • Very excited about the clinical profile in AD and the approvability of the product in a large and rapidly growing market. We also just recently submitted the NDA for topical roflumilast foam and seborrheic dermatitis. And that sets us up for a potential approval late this year or very early part of 2024. And we also already submitted a supplemental NDA for ZORYVE in plaque psoriasis down to the age of 2, which will further read on the safety profile of ZORYVE in plaque psoriasis

    對 AD 的臨床概況以及該產品在龐大且快速增長的市場中的認可度感到非常興奮。我們最近還提交了外用羅氟司特泡沫和脂溢性皮炎的 NDA。這使我們有可能在今年晚些時候或 2024 年初獲得批准。我們還已經提交了 ZORYVE 用於 2 歲以下斑塊狀銀屑病的補充 NDA,這將進一步閱讀 ZORYVE 在斑塊狀銀屑病

  • We also continue to progress our early pipeline with the acquisition of ARQ-234, our first biologic for atopic dermatitis and the Phase 1b initiation of ARQ-255 in alopecia areata, which leverages our unique 4D technology and potentially could be the only topical treatment for alopecia areata.

    我們還通過收購 ARQ-234 繼續推進我們的早期產品線,這是我們的第一個治療特應性皮炎的生物製劑,以及 ARQ-255 在斑禿中的 1b 期啟動,它利用我們獨特的 4D 技術,可能是唯一的局部治療藥物斑禿。

  • And finally, not only what we accomplish matters, but how we accomplish it matters to us as well. And so we're very proud that we issued our first ESG report in the fourth quarter, highlighting the progress that we're making on these important topics.

    最後,不僅我們完成了什麼很重要,我們如何完成它對我們也很重要。因此,我們非常自豪我們在第四季度發布了第一份 ESG 報告,強調了我們在這些重要主題上取得的進展。

  • If you move on to Slide #7, just a reminder of our broad and deep medical dermatology pipeline and the progress that we've made recently since the last call on 3 programs, in particular, I call your attention to the 3 red arrows, highlighting some of our recent progress in advancing the pipeline with the NDA and seb derm the initiation of the Phase Ib in for ARQ-255 and the acquisition of and progress on ARQ-234.

    如果您轉到幻燈片 #7,這只是提醒我們廣泛而深入的醫學皮膚病學管道以及自上次召集 3 個項目以來我們最近取得的進展,特別是,我提請您注意 3 個紅色箭頭,強調了我們最近在推進管道與 NDA 和 seb derm 的一些進展,啟動了 ARQ-255的 Ib 階段,以及 ARQ-234的收購和進展。

  • Turning to Slide #8. There really are 4 keys to our strategy for the long-term success of ZORYVE. One is positioning ZORYVE to replace a significant percentage of topical steroids, which we're going to spend some time talking about today. Secondly, providing a positive clinical experience for doctors and patients when they use ZORYVE. Third is obtaining broad, high-quality coverage, and lastly, is ensuring profitable growth through a rapid stabilization of our gross to net.

    轉到幻燈片#8。我們的 ZORYVE 長期成功戰略確實有 4 個關鍵。一種是將 ZORYVE 定位為替代相當大比例的外用類固醇,我們今天將花一些時間討論這一點。其次,在使用 ZORYVE 時為醫生和患者提供積極的臨床體驗。第三是獲得廣泛、高質量的覆蓋,最後是通過快速穩定我們的毛淨值來確保盈利增長。

  • If you turn to Slide 9, I want to spend just a couple of minutes talking about the first of these 4 elements of our strategy, the important -- and I think it's really important for investors to understand that the key to realizing ZORYVE's real potential is the conversion of a significant percentage of topical steroids over to ZORYVE.

    如果你翻到幻燈片 9,我想花幾分鐘談談我們戰略的這 4 個要素中的第一個,重要的是——我認為對投資者來說,了解實現 ZORYVE 真正潛力的關鍵是非常重要的是很大比例的局部類固醇轉化為 ZORYVE。

  • To give you some context, there are about 12 million prescriptions a year for topical steroids. That's something like 25 million every week versus 5,000 prescriptions, maybe 6,000 per week for ZORYVE and the other new non-oil [ph 0:05:20] combined. So we're really just tracking the surface in terms of the opportunity for ZORYVE.

    為了給您一些背景信息,每年大約有 1200 萬份外用類固醇的處方。 ZORYVE 和其他新的非油 [ph 0:05:20] 加起來每周大約有 2500 萬,而 5,000 個處方,每周可能有 6,000 個。因此,就 ZORYVE 的機會而言,我們實際上只是在跟踪表面。

  • We believe that there are 3 critical elements for making that conversion happen. The first one is that prescribers need to see a need, a reason to change and move away from topical steroids. The second is that ZORYVE needs to provide a product profile that satisfies the needs of prescribers and patients and the third one is it needs to be as easy to write ZORYVE as it is for that next topical steroid.

    我們認為實現這種轉變有 3 個關鍵因素。第一個是開處方者需要看到一種需要,一個改變和遠離局部類固醇的理由。第二個是 ZORYVE 需要提供滿足處方者和患者需求的產品簡介,第三個是 ZORYVE 需要像下一個外用類固醇一樣容易編寫。

  • That all sounds great, but is that possible? If you go to the next slide, to Slide 10. We're showing here several different markets where you had a stable, mature and generic market and then an introduction of a new class of drugs. And what you can see in each one of these instances is that there is a very significant conversion over time as well as some significant market growth actually in a couple of instances with the introduction of that new class of drugs.

    聽起來不錯,但這可能嗎?如果你轉到下一張幻燈片,到幻燈片 10。我們在這裡展示了幾個不同的市場,你有一個穩定、成熟和通用的市場,然後介紹了一種新的藥物。在這些實例中的每一個實例中,您都可以看到,隨著時間的推移,隨著新型藥物的引入,轉化率非常顯著,而且實際上在一些實例中市場也出現了顯著增長。

  • And so you're looking at examples here from the anticoagulation market, the conversion from warfarin over to Factor Xa's, the schizophrenia market, the conversion of neuroleptics over atypical antipsychotics, the GERD market with conversion of H2 to PPI. And then most recently, the conversion of the oral migraine market from triptans over to the oral CGRPs, which is still very early days, but you can see a very rapid conversion trend even in that market.

    所以你在這裡看到的例子來自抗凝劑市場,從華法林到 Xa 因子的轉換,精神分裂症市場,抗精神病藥從非典型抗精神病藥的轉換,GERD 市場從 H2 到 PPI 的轉換。最近,口服偏頭痛市場從曲坦類藥物轉變為口服 CGRPs,這還處於早期階段,但即使在該市場中,您也可以看到非常快速的轉變趨勢。

  • If you go to Slide 11, as you look across all these markets, and we're actually -- we were showing also the antidepressant market and the conversion of TCA to SSRI. What you can see is over time, there is a very dramatic shift to the new class of drugs, and that growth that shift continues throughout the life cycle of the product. And on average, about 50% of these markets all converted by year 7 or year 8 after the introduction of a new class of drugs. And when you think about those 12 million prescriptions I talked about is 50% of that market converted over to new novel nonsteroidal, I think that gives you some sense of the true opportunity for ZORYVE.

    如果您轉到幻燈片 11,當您查看所有這些市場時,我們實際上 - 我們還展示了抗抑鬱藥市場和 TCA 向 SSRI 的轉化。你可以看到隨著時間的推移,新型藥物發生了非常顯著的轉變,並且這種轉變的增長在產品的整個生命週期中持續存在。平均而言,這些市場中約有 50% 在新藥上市後的第 7 年或第 8 年全部轉變。當你想到我談到的那 1200 萬個處方時,50% 的市場轉化為新的非甾體類藥物,我認為這讓你對 ZORYVE 的真正機會有所了解。

  • So if you move on to Slide 11 -- sorry, I'm on Slide 12. So I want to take just a moment and have Patrick comment on the first of these 3 elements around what we're hearing from the dermatology community about the need to shift away from topical steroids. Patrick?

    所以,如果你繼續看幻燈片 11——抱歉,我在看幻燈片 12。所以我想花點時間讓 Patrick 就我們從皮膚病學界聽到的關於這三個要素中的第一個發表評論需要遠離局部類固醇。帕特里克?

  • Patrick E. Burnett - Senior VP & Chief Medical Officer

    Patrick E. Burnett - Senior VP & Chief Medical Officer

  • Yes. As Frank mentioned, one key to moving dermatologists from topical steroids to new or nonsteroidal alternatives is the recognition within the specialty that a change is needed.

    是的。正如 Frank 提到的,將皮膚科醫生從外用類固醇轉移到新的或非類固醇替代品的一個關鍵是在專業內認識到需要改變。

  • Recall last year at our Investor Day held during the AAD, we noted a change in the field regarding the surging interest in topical nonsterile treatments. This has continued to build fueled by multiple approvals, including ZORYVE across both psoriasis and atopic dermatitis.

    回想一下去年在 AAD 期間舉行的投資者日,我們注意到該領域發生了一個變化,即對局部非無菌治療的興趣激增。這在多項批准的推動下繼續建立,包括 ZORYVE 治療牛皮癬和特應性皮炎。

  • The derm community with KOLs leading from the front is educating that steroids were fine when there were no other acceptable options, but this has changed with the introduction of the new novel nonsteroidals. They've noted the changing standard of care and raised questions about the clinical appropriateness of using topical steroids to manage these conditions chronically in the current environment.

    以 KOL 為首的真皮社區正在教育,當沒有其他可接受的選擇時,類固醇是好的,但隨著新型非甾體類藥物的引入,這種情況發生了變化。他們注意到不斷變化的護理標準,並對在當前環境下長期使用局部類固醇來控制這些病症的臨床適宜性提出了疑問。

  • Another aspect is patient expectations. This is something we're hearing from the podium, but I'm also hearing it frequently from doctors talking to doctors out in the field. Many patients are challenging doctors when they're presented with a prescription for topical steroids. Finally, we know that there is a movement to update treatment guidelines to reflect the new nonsteroidal treatment options, and this is a favorable change as well.

    另一方面是患者的期望。這是我們從講台上聽到的,但我也經常從醫生與外地醫生交談中聽到。當醫生開出外用類固醇的處方時,許多患者都在挑戰醫生。最後,我們知道有更新治療指南以反映新的非類固醇治療選擇的運動,這也是一個有利的變化。

  • So taken together, we are a leading dermatologists and key opinion leaders saying from the podium that it's now become hard to justify the chronic use of steroids given the well-documented risk of steroid side effects such as striae atrophy or bone fracture. I'll turn you over now to Ken Lock to update on the commercial progress.

    綜上所述,我們是領先的皮膚科醫生和主要意見領袖,他們在講台上說,現在很難證明長期使用類固醇是合理的,因為類固醇副作用(如皮紋萎縮或骨折)的風險已得到充分證明。我現在將您轉交給 Ken Lock 以更新商業進展。

  • Kenneth A. Lock - Chief Commercial Officer

    Kenneth A. Lock - Chief Commercial Officer

  • All right. Thank you, Patrick. And let me pivot now to talk a little bit about launch progress and the commercial highlights in the fourth quarter of 2022.

    好的。謝謝你,帕特里克。現在讓我談談 2022 年第四季度的發布進度和商業亮點。

  • So moving on to Slide 14. You can see our ZORYVE launch continues to build with steady and sustainable weekly prescription growth for our first full quarter of launch. And we've continued to build in the first quarter of 2023 here through the typical noise and choppiness related to insurance and deductible resets and a multitude of holiday shortened weeks. We've now attained well over 20,000 prescriptions launched to date with plenty of headroom for continued growth, as Frank mentioned, and our confidence continues to grow every week that we're providing the best topical treatment solution to plaque psoriasis patients.

    所以繼續看幻燈片 14。您可以看到我們的 ZORYVE 發布繼續以穩定和可持續的每周處方增長為我們發布的第一個完整季度。我們在 2023 年第一季度繼續在這裡建設,通過與保險和免賠額重置相關的典型噪音和波動以及大量假期縮短週。正如 Frank 提到的那樣,我們現在已經推出了超過 20,000 種處方,並且有足夠的空間繼續增長,而且我們每週都在為斑塊狀銀屑病患者提供最佳的局部治療解決方案。

  • Now as it relates to a core element of driving the conversion from steroids, the ZORYVE profile continues to satisfy the needs of prescribers and patients with exceptional feedback thus far. In particular, prescribers have been favorably impressed by the speed of onset, the ability to treat the toughest plaques not only on elbows and knees, but even on the palms and souls and the world-class tolerability profile that is playing out even more strongly in the real world versus what we saw in our trials.

    現在,由於它涉及到驅動類固醇轉化的核心要素,因此 ZORYVE 概況繼續滿足處方醫生和患者的需求,迄今獲得了出色的反饋。特別是,開處方者對起效速度、治療肘部和膝蓋上最堅硬斑塊的能力、甚至手掌和靈魂上最堅硬的斑塊的能力以及世界級的耐受性概況印象深刻真實世界與我們在試驗中看到的對比。

  • Physicians and patients need to see that a new product is worthy enough to truly become a viable replacement to topical corticosteroids through repeating a robust trial. And we continue to be confident that ZORYVE can deliver on that promise. Remembering the prior attempts to replace steroid [ph 0:10:27] agents has disappointed for one reason or another, including lack of sufficient efficacy, tolerability concerns or both.

    醫生和患者需要看到一種新產品的價值足以通過重複強有力的試驗真正成為外用皮質類固醇的可行替代品。我們繼續相信 ZORYVE 能夠兌現這一承諾。記住先前嘗試替代類固醇 [ph 0:10:27] 藥物因某種原因而感到失望,包括缺乏足夠的療效、耐受性問題或兩者兼而有之。

  • Moving on to Slide 15, our physician intent to prescribe continues to be very strong. This is data from our recent physician ATU fielded a few months into launch, reflecting prescriber intent and prior behavior contrasted to expected behavior across patient severities and psoriasis. ZORYVE intended use is expected to increase two to threefold across patients severity types in the next 6 months, all coming at the expense of decreased utilization of the mid and high potency steroids that are associated with psoriasis treatment.

    轉到幻燈片 15,我們的醫生開處方的意願仍然非常強烈。這是我們最近的醫生 ATU 在發布幾個月後提供的數據,反映了處方者的意圖和先前的行為與患者嚴重程度和牛皮癬的預期行為形成對比。在接下來的 6 個月中,ZORYVE 的預期用途預計將在嚴重程度類型的患者中增加兩到三倍,所有這些都是以減少與銀屑病治療相關的中高效類固醇的使用為代價的。

  • This is exactly what we want to see and emblematic of the march toward realizing our full potential. The willingness and intent to move away from the topical standard of care is indicative that ZORYVE is solving real challenges in topical psoriasis treatment, tolerability, efficacy, the ability to be used long term and the ability to be used everywhere are hallmarks.

    這正是我們希望看到的,也是實現我們全部潛力的征程的象徵。擺脫局部護理標準的意願和意圖表明 ZORYVE 正在解決局部銀屑病治療中的真正挑戰,耐受性、療效、長期使用的能力和在任何地方使用的能力都是標誌。

  • Moving to Slide 16. This slide gives a glimpse into what types of prior therapies are being switched from to ZORYVE and a view into the types of patients adopting therapy. ZORYVE is currently playing a broad role and at the left, you can see that the majority are almost 2/3 of switches to switched are from a topical corticosteroid or steroid combination product as expected as well as an increasing amount from other branded therapies as you can see in the chart as well as replacing older inferior nonsteroidal agents such as calcineurin inhibitors and vitamin D analogs.

    轉到幻燈片 16。這張幻燈片讓您可以一瞥哪些類型的先前療法正在從 ZORYVE 轉變為 ZORYVE,以及哪些類型的患者正在接受治療。 ZORYVE 目前發揮著廣泛的作用,在左側,您可以看到大多數將近 2/3 的轉換來自外用皮質類固醇或類固醇組合產品,正如預期的那樣,以及越來越多的其他品牌療法可以在圖表中看到以及替代舊的劣質非甾體藥物,如鈣調神經磷酸酶抑製劑和維生素 D 類似物。

  • As with any switching behavior, the satisfaction with the clinical profile for the -- for reasons of efficacy, safety or tolerability remain the key driver of therapeutic switch and it's becoming increasingly apparent from our position and patient feedback that this is driving this period-over-period.

    與任何轉換行為一樣,出於療效、安全性或耐受性的原因,對臨床概況的滿意度仍然是治療轉換的關鍵驅動因素,而且從我們的立場和患者反饋來看,這越來越明顯地推動了這一時期的發展-時期。

  • Now touching on the third condition that Frank mentioned regarding what's needed to satisfy a full transition away from topical corticosteroid, I'll now turn to access and reimbursement. On Slide 17, we previously stated that one of the key concepts for one's product to be as easy to write and obtain as a next steroid is really the minimization of physician hassle including step edits and prior authorizations. And we're pleased to bring you progress along the lines of our stated goal of broad and high-quality access.

    現在談到 Frank 提到的第三個條件,即滿足從局部皮質類固醇完全過渡需要什麼,我現在將轉向獲取和報銷。在幻燈片 17 上,我們之前說過,要使產品像下一個類固醇一樣易於編寫和獲取,關鍵概念之一實際上是最大限度地減少醫生的麻煩,包括步驟編輯和事先授權。我們很高興能按照我們既定的廣泛和高質量訪問目標為您帶來進展。

  • Now at the onset, we said that these things, including high-quality coverage, faster formulary adoption, preservation of long-term gross-to-net and optimization for our volume and franchise value are important. Remember that this is the first of 4 launches for roflumilast and that our decisions are being made with the lens of enabling strong access across that portfolio of launches, product presentations and patient types.

    現在開始,我們說這些事情,包括高質量的覆蓋範圍、更快的處方採用、保持長期毛淨值以及優化我們的數量和特許經營價值都很重要。請記住,這是 roflumilast 的 4 次發布中的第一個,我們的決定是在考慮在發布組合、產品展示和患者類型中實現強大訪問的鏡頭下做出的。

  • We've now secured formulary coverage, not just a contract with coverage at our second -- or second of the 3 large national PBMs effective March 1, building on the coverage with ESI that we announced at the end of 2022 and at a preferred Tier 2 coverage throughout with no preauthorizations and a single step to a topical corticosteroid [ph 0:13:32], which represents a gold standard quality of coverage.

    我們現在已經獲得了處方覆蓋,而不僅僅是我們的第二個覆蓋範圍的合同 - 或者 3 月 1 日生效的 3 個大型國家 PBM 中的第二個,建立在我們在 2022 年底宣布的 ESI 的覆蓋範圍和首選層2 次覆蓋,沒有預授權,一步到外用皮質類固醇 [ph 0:13:32],代表了黃金標準的覆蓋質量。

  • Moving to Slide 18, taking a deeper dive into the current nonsteroidal topical product coverage. And at the time of this call, based on our sources, this chart depicts the high-quality differentiated access that compares favorably on both time to coverage relative to launch date and quality in terms of step edit and prior authorizations versus recently other recently launched products.

    轉到幻燈片 18,更深入地了解當前的非類固醇外用產品覆蓋範圍。在本次電話會議期間,根據我們的消息來源,這張圖表描繪了高質量的差異化訪問,與最近推出的其他最近推出的產品相比,在步驟編輯和事先授權方面,與發布日期相關的覆蓋時間和質量方面都有優勢.

  • Importantly, this for us represents 2 of the 3 major national PBMs within roughly 6 months post launch, a first-in-category pace and importantly, with no prior authorization, a key tenant of our access strategy. This brings us another step closer toward making ZORYVE as easy to write and obtain as the next topical corticosteroid product, which is key to fitting in the everyday treatment algorithm of dermatologists.

    重要的是,這對我們來說代表了啟動後大約 6 個月內 3 個主要國家 PBM 中的 2 個,這是同類產品中首屈一指的速度,而且重要的是,在沒有事先授權的情況下,這是我們訪問策略的關鍵租戶。這使我們更接近於使 ZORYVE 像下一個外用皮質類固醇產品一樣易於編寫和獲取,這是適應皮膚科醫生日常治療算法的關鍵。

  • In conclusion, on Slide 20, I spoke from our Investor Day last year on the 3 core pillars to commercial success, anchored by the unparalleled product profile as the foundation. In terms of driving prescriber awareness and use, we're on the path with over 4,000 unique writers since launch and an aided awareness well over 90% for ZORYVE as per our survey field in November.

    總之,在幻燈片 20 上,我在去年的投資者日談到了商業成功的 3 個核心支柱,以無與倫比的產品概況為基礎。在提高開處方者的意識和使用方面,自推出以來,我們已經擁有超過 4,000 名獨特的作者,根據我們 11 月份的調查領域,ZORYVE 的輔助意識遠遠超過 90%。

  • In terms of patient engagement and driving patient positive experience, we already spoke to the testimonials daily on the overwhelmingly positive experience at ZORYVE. But in addition, we've been continuing to think about how to appropriately accelerate patient engagement in terms of awareness, consideration and request, especially now as access is coming more fully online, and we want to drive into that.

    在患者參與和推動患者積極體驗方面,我們已經每天就 ZORYVE 壓倒性的積極體驗與推薦人交談。但除此之外,我們一直在繼續思考如何在意識、考慮和請求方面適當地加快患者的參與,尤其是現在訪問越來越完全在線,我們希望推動這一點。

  • Now we currently have a very active digital social media and DTC campaign in place, but we are vigorously evaluating whether and when a highly focused connected TV campaign could make sense for ZORYVE. And like any other business, repeat business is the greatest sign of customer satisfaction and our refills continue to escalate, which is a validation of that positive experience.

    現在,我們目前開展了非常活躍的數字社交媒體和 DTC 活動,但我們正在積極評估高度集中的聯網電視活動是否以及何時對 ZORYVE 有意義。與任何其他業務一樣,回頭客是客戶滿意度的最大標誌,我們的續訂量不斷增加,這是對這種積極體驗的驗證。

  • Lastly, broad high-quality access is coming into focus as discussed, with coverage secured at 2 of the 3 major PBMs in just 6 months post product availability, remember that the benchmarks suggest 12 to 18 months to secure broad commercial coverage typically.

    最後,正如所討論的那樣,廣泛的高質量訪問正在成為焦點,在產品上市後的短短 6 個月內,3 個主要 PBM 中的 2 個獲得了覆蓋,請記住,基準建議通常需要 12 到 18 個月才能確保廣泛的商業覆蓋。

  • Importantly, the quality of one step, no prior authorization formulary coverage of our most recent announcement is highly aligned with our goals of obtaining as much prior authorization to free access as possible to speed the flow of conversion of legacy products to ZORYVE and making it very easy to fit into the flow of prescribers today.

    重要的是,一步的質量,我們最近發布的沒有事先授權的處方集覆蓋範圍與我們的目標高度一致,即盡可能多地獲得免費訪問的事先授權,以加快遺留產品向 ZORYVE 的轉換流程,並使其非常很容易適應今天的處方者流動。

  • I'll hand it over now to Patrick for an R&D update.

    我現在將其交給 Patrick 進行研發更新。

  • Patrick E. Burnett - Senior VP & Chief Medical Officer

    Patrick E. Burnett - Senior VP & Chief Medical Officer

  • Thanks, Ken. Starting on Slide 21. Within the psoriasis community, excitement continues to grow for ZORYVE. I want to start with some compelling data that we presented at the Winter Clinical Meeting in January, which was very well received by physicians and KOLs. These are data from our 52-week open-label psoriasis study showing durable efficacy with patients maintaining clear or almost clear. That's an IGA of 0 or 1 for a median duration of about 10 months.

    謝謝,肯。從幻燈片 21 開始。在銀屑病社區內,ZORYVE 的興奮度持續增長。我想從我們在 1 月份的冬季臨床會議上展示的一些令人信服的數據開始,這些數據受到了醫生和 KOL 的好評。這些是我們為期 52 週的開放標籤銀屑病研究的數據,顯示患者保持清除或幾乎清除的持久療效。這是 0 或 1 的 IGA,平均持續時間約為 10 個月。

  • Also worth noting is that 57% of patients achieved an IGA of 01 at any point in this 2-week trial. I'm really excited about these data. They've been very easy to interpret for docs and are particularly important to build momentum as patients are coming back to physicians' offices with positive experience that gives them a clear picture of what to expect as they continue with their treatment.

    同樣值得注意的是,在為期 2 週的試驗中,57% 的患者在任何時候的 IGA 都達到了 01。我對這些數據感到非常興奮。對於醫生來說,它們非常容易解釋,並且對於建立勢頭尤為重要,因為患者帶著積極的經驗回到醫生辦公室,讓他們清楚地了解在繼續治療時會發生什麼。

  • On Slide 22 now, physician feedback on AD, the data have been very positive. What continues to jump out is the speed of onset in our trials across both psoriasis and atopic dermatitis, which gives an early indication that the drug is working in the disease and, of course, the ever important safety and tolerability profile, which has been consistent across all of our programs.

    現在在幻燈片 22 上,醫生對 AD 的反饋,數據非常積極。繼續跳出的是我們在牛皮癬和特應性皮炎試驗中的發病速度,這提供了該藥物在疾病中起作用的早期跡象,當然還有重要的安全性和耐受性概況,這一直是一致的在我們所有的項目中。

  • Recall triamcinolone, a mid-potency topical steroid is a standard of care in AD. And then taking it 1 and 2, ZORYVE demonstrated comparable efficacy within the safety concerns from -- considerable efficacy without the safety concerns from chronic use of topical steroids.

    回想一下去炎松,一種中等效力的外用類固醇,是 AD 的標準治療方法。然後將它作為 1 和 2,ZORYVE 在安全問題方面表現出相當的療效——相當大的療效,而沒有長期使用局部類固醇的安全問題。

  • Taking a closer look at the EASI-75 data from INTEGUMENT-1 and INTEGUMENT-2 on Slide 22. We showed statistical significance at week 1 with clear separation already from vehicle. Then at week 2, about 30% of patients achieved a 75% clearance already, and this continued to increase to over 40% at week 4, which was the end of treatment.

    仔細查看幻燈片 22 上來自 INTEGUMENT-1 和 INTEGUMENT-2 的 EASI-75 數據。我們在第 1 周顯示了統計顯著性,並且已經與車輛明顯分離。然後在第 2 週,大約 30% 的患者已經達到 75% 的清除率,並且在治療結束的第 4 周繼續增加到 40% 以上。

  • Keep in mind, steroids work quickly. So these data are exactly what physicians want to see. This gets back to the point about driving physician interest and uptake once this product is approved in atopic dermatitis.

    請記住,類固醇起效很快。所以這些數據正是醫生們希望看到的。一旦該產品被批准用於特應性皮炎,這又回到了驅動醫生興趣和吸收的問題上。

  • Turning to Slide 23. It's just a critical element for patients. It's the most early -- most important early indicator for AD patients for them to know whether or not the drug is working. And here again, we showed statistical significance in separation already at week 1, building nicely to nearly 1/3 of patients by week 4.

    轉到幻燈片 23。它只是患者的關鍵要素。它是 AD 患者了解藥物是否有效的最早——也是最重要的早期指標。在這裡,我們在第 1 週就已經顯示出分離的統計顯著性,到第 4 週時,將近 1/3 的患者很好地建立起來。

  • Looking forward, we'll showcase some exciting daily itch data at the AAD in a few weeks, which will really nicely characterize the early onset of action of this drug within the itch of atopic dermatitis.

    展望未來,我們將在幾週後在 AAD 上展示一些令人興奮的日常瘙癢數據,這將很好地描述這種藥物在特應性皮炎瘙癢中的早期起效特徵。

  • On Slide 24, I want to touch briefly on safety because safety and tolerability are so critical for this disease, which has a substantial proportion of pediatric patients. This table shows rates for the adverse events in either of our 2 Phase III trials to have a 2% or greater incidence in any arm.

    在幻燈片 24 上,我想簡要談談安全性,因為安全性和耐受性對於這種在兒科患者中佔很大比例的疾病至關重要。此表顯示了我們的 2 項 III 期試驗中任何一項的不良事件發生率在任何一組中的發生率為 2% 或更高。

  • Not looking to go into any detail here. These are just data that we have shown previously. Just key takeaway is to highlight the favorable safety profile, which is consistent with our other programs, including psoriasis and given that AD is a disease with a skin barrier defect as a key part of the pathophysiology. These patients tend to be sensitive to local adverse events with topicals and many agents irritate the skin in individuals with atopic dermatitis. Here, again, I think we're reaping some benefits from our formulation, which avoids contact irritants like propylene glycol.

    不想在這裡詳細介紹。這些只是我們之前展示的數據。關鍵要點是強調良好的安全性,這與我們的其他項目一致,包括牛皮癬,並且考慮到 AD 是一種皮膚屏障缺陷疾病,是病理生理學的關鍵部分。這些患者往往對局部不良事件敏感,許多藥物會刺激特應性皮炎患者的皮膚。在這裡,我認為我們再次從我們的配方中獲得了一些好處,它避免了丙二醇等接觸刺激物。

  • Finally, turning to Slide 25. I have some of our accomplishments and upcoming milestones. You can see significant sustained long-term growth potential with additional approvals, label expansions, both within the U.S. and outside as well. I'm very excited to highlight our seb derm NDA submission earlier this month, which puts us with a potential approval in late 2023 for the seb derm foam formulation.

    最後,轉到幻燈片 25。我有一些我們的成就和即將到來的里程碑。您可以看到顯著的持續長期增長潛力,包括美國境內外的額外批准、標籤擴展。我很高興地強調我們本月早些時候提交的 seb derm NDA,這使我們有可能在 2023 年底獲得 seb derm 泡沫配方的批准。

  • Here, physician excitement is palpable for the foam formulation. We're hearing a lot about it when we're talking to derms out in the field, but largely, this is being underappreciated, we think, by Wall Street. Coming back around to our most near-term milestones, we have the action date with Health Canada at the end of April for psoriasis.

    在這裡,醫生對泡沫配方的興奮是顯而易見的。當我們在現場與皮膚科醫生交談時,我們聽到了很多關於它的信息,但我們認為,在很大程度上,華爾街沒有充分認識到這一點。回到我們最近的里程碑,我們在 4 月底與加拿大衛生部就銀屑病採取了行動日期。

  • Then next, we have a lot going on in atopic dermatitis in the second half of 2023, the submission of our sNDA for ages 6 and above in AD as well as top line data readout for the INTEGUMENT-PED study. Again, very excited about the roflumilast cream clinical profile MAD [ph 0:20:24], which I shared with you today, especially the rapid onset of action, and we see this as a significant opportunity for ZORYVE in this large and growing market. Q4 is the anticipated approval date for the sNDA in psoriasis in children down to the age of 2, which Frank mentioned earlier.

    接下來,我們在 2023 年下半年在特應性皮炎方面有很多進展,我們提交了 6 歲及以上 AD 的 sNDA 以及 INTEGUMENT-PED 研究的頂線數據讀出。再次,對我今天與大家分享的羅氟司特乳膏臨床資料 MAD [ph 0:20:24] 感到非常興奮,尤其是起效迅速,我們認為這是 ZORYVE 在這個不斷增長的龐大市場中的重要機會.第 4 季度是 sNDA 用於 2 歲以下兒童銀屑病的預期批准日期,Frank 之前提到過。

  • And finally, we plan a submission for foam for the scalp psoriasis in the first quarter of 2024 after an anticipated seb derm approval. On that note, I'll turn it over to Scott.

    最後,我們計劃在預期的 seb derm 批准後,於 2024 年第一季度提交用於治療頭皮牛皮癬的泡沫。關於這一點,我會把它交給斯科特。

  • Scott L. Burrows - CFO & Principal Accounting Officer

    Scott L. Burrows - CFO & Principal Accounting Officer

  • Thanks, Patrick. Turning to Page 27 of the slide deck. Net product revenues were $3 million for our first full quarter of launch driven by ZORYVE steady growth in unit demand. Our gross to net discount rate improved modestly in the quarter and continues to be meaningfully better than other recent branded topical launches at similar time points.

    謝謝,帕特里克。翻到幻燈片的第 27 頁。在 ZORYVE 單位需求穩步增長的推動下,我們推出的第一個完整季度的淨產品收入為 300 萬美元。我們的毛淨折扣率在本季度略有改善,並且繼續明顯好於類似時間點最近推出的其他品牌主題產品。

  • Looking ahead to the first quarter of 2023, we are very pleased with the continued steady week-over-week growth that we can all see in the weekly script data and today's new payer formulary coverage announcement bodes well for further volume growth. We do expect first quarter revenues to be impacted by the typical higher copay program cost at most commercial products experienced in the first quarter of every year, leading to temporary erosion mid-Q1 versus net discount rate.

    展望 2023 年第一季度,我們對每週腳本數據中都可以看到的持續穩定的每週增長感到非常高興,而今天新的付款人處方覆蓋公告預示著進一步的銷量增長。我們確實預計第一季度的收入將受到每年第一季度大多數商業產品的典型較高的共付額計劃成本的影響,導致第一季度中期相對於淨貼現率的暫時侵蝕。

  • Given this dynamic, first quarter net sales may not be meaningfully higher than the fourth quarter as our continued demand growth is offset by the higher gross to net. We believe that this is just early launched noise. As I just mentioned, we have been growing script nicely. And beyond Q1, we expect the additional formulary coverage we announced today, combined with the earlier Express Scripts announcement to drive continued volume growth as well as improved gross to net.

    鑑於這種動態,第一季度淨銷售額可能不會明顯高於第四季度,因為我們持續的需求增長被較高的毛淨銷售額所抵消。我們認為這只是早期推出的噪音。正如我剛才提到的,我們一直在很好地發展腳本。在第一季度之後,我們預計我們今天宣布的額外處方覆蓋範圍,結合早些時候的 Express Scripts 公告,將推動持續的銷量增長以及毛淨值的提高。

  • We continue to believe that we will achieve a steady-state gross to net around 50% and potentially sooner than is typical. This will translate into more meaningful revenue realization through the balance of the year and into future years.

    我們仍然相信,我們將實現穩態毛淨比 50% 左右,而且可能比通常情況更快。這將在今年餘下時間和未來幾年轉化為更有意義的收入實現。

  • Turning to the fourth quarter P&L on Slide 28. Research and development expenses were $34 million in the quarter. The decrease year-over-year is primarily due to lower clinical development costs for our topical roflumilast programs. We expect R&D to tick up slightly in Q1 versus Q4 and then be relatively stable for the balance of 2023.

    轉到幻燈片 28 上的第四季度損益表。本季度的研發費用為 3400 萬美元。同比下降主要是由於我們的外用羅氟司特項目的臨床開發成本較低。我們預計研發在第一季度相對於第四季度略有上升,然後在 2023 年餘下時間保持相對穩定。

  • SG&A expenses were $37 million for the quarter, increasing largely due to higher commercialization expenses for the ZORYVE launch. We expect some sequential growth in SG&A as we continue to invest in the psoriasis launch and prepare for our potential launches in seborrheic dermatitis and atopic dermatitis. Net loss was $72 million for the quarter, flat to Q4 2021.

    本季度的 SG&A 費用為 3700 萬美元,增加的主要原因是 ZORYVE 發布的商業化費用增加。隨著我們繼續投資於牛皮癬的推出並為我們在脂溢性皮炎和特應性皮炎方面的潛在推出做準備,我們預計 SG&A 會出現一些連續增長。本季度淨虧損為 7200 萬美元,與 2021 年第四季度持平。

  • Turning to our final slide on Page 29. We provide some key balance sheet and cash flow items. As a result of the financing Frank mentioned, our balance sheet remains strong with cash of approximately $410 million as of December 31. Our capital allocation priorities remain very targeted in 2023 prioritizing, of course, this ZORYVE launch in plague psoriasis as well as preparations for the upcoming potential launches in seborrheic dermatitis and atopic dermatitis.

    轉到第 29 頁的最後一張幻燈片。我們提供了一些關鍵的資產負債表和現金流量項目。由於 Frank 提到的融資,截至 12 月 31 日,我們的資產負債表仍然強勁,現金約為 4.1 億美元。我們的資本分配優先事項在 2023 年仍然非常有針對性,當然,優先考慮 ZORYVE 在鼠疫銀屑病中的推出以及準備即將推出的脂溢性皮炎和特應性皮炎的潛在產品。

  • And finally, the continued advancement of our pipeline, specifically our topical JAK program in alopecia areata and our CD200R program in atopic dermatitis. This concludes the financial update.

    最後,我們管道的持續推進,特別是我們在斑禿中的局部 JAK 程序和在特應性皮炎中的 CD200R 程序。財務更新到此結束。

  • I'll now turn the call back to Frank to wrap up our prepared remarks.

    我現在將電話轉回弗蘭克,以結束我們準備好的發言。

  • Todd Franklin Watanabe - President, CEO & Director

    Todd Franklin Watanabe - President, CEO & Director

  • Okay. So I want to thank everyone for joining. I know we covered a lot of material in very short order. So at this point, we're going to transition to a Q&A, and I'll turn it over to Eric.

    好的。所以我要感謝大家的加入。我知道我們在很短的時間內涵蓋了很多材料。所以在這一點上,我們將過渡到問答環節,我會把它交給埃里克。

  • Eric McIntyre - Head of IR

    Eric McIntyre - Head of IR

  • Olivia, we can open the line, please.

    奧利維亞,我們可以開通電話了。

  • Operator

    Operator

  • (Operator Instructions) And our first question coming from the line of Vikram Purohit from Morgan Stanley.

    (操作員說明)我們的第一個問題來自摩根士丹利的 Vikram Purohit。

  • Vikram Purohit - Equity Analyst

    Vikram Purohit - Equity Analyst

  • So 2 from our side. So you provided some color about the profile of patients being prescribed ZORYVE. But I was wondering if you could speak about, how they're receiving the treatment from what you're seeing? Has it mostly been monotherapy so far or are they getting it in combination with other options?

    所以我們這邊有 2 個。所以你提供了一些關於接受 ZORYVE 處方的患者概況的顏色。但我想知道你是否可以談談,從你所看到的情況來看,他們是如何接受治療的?到目前為止,它主要是單一療法還是他們將其與其他選擇結合使用?

  • And then secondly, pivoting to atopic dermatitis, assuming approval in that indication for roflumilast cream, how do you think gross to net could trend in that indication? And how would you kind of compare and contrast the trend line for gross to net there versus what you're seeing with psoriasis?

    然後其次,轉向特應性皮炎,假設羅氟司特乳膏的適應症獲得批准,您認為該適應症的毛淨值趨勢如何?您如何比較和對比那裡的總淨值趨勢線與您在牛皮癬上看到的趨勢線?

  • Kenneth A. Lock - Chief Commercial Officer

    Kenneth A. Lock - Chief Commercial Officer

  • Hey, Vikram. This is Ken. So as it relates to specifically patient types or mono and combination therapy. So from the source of business lines, you can see that primarily, it seems that though the predecessor therapy is a single therapy. However, in the field, we also see lots of instances where physicians are doing what they normally do with topicals, which is adding them on to the back of a biologic. And while not specifically indicated for that use case, we're obviously not contraindicated for that either. So we're seeing a mix of that.

    嘿,維克拉姆。這是肯。因此,因為它涉及特定的患者類型或單一療法和聯合療法。所以從業務線的源頭上,大家可以看出,主要是,雖然前身療法好像是一個單一的療法。然而,在該領域,我們也看到很多情況下,醫生正在做他們通常對局部用藥所做的事情,即將它們添加到生物製劑的背面。雖然沒有具體說明該用例,但我們顯然也沒有禁忌。所以我們看到了兩者的混合。

  • Now remember, biologics and systemic use is only a fraction of the overall market. So anywhere between about 20%, 25% at most patients are on a systemic and that would represent the maximal combination use, but monotherapy is largely the situation in which people come from topical corticosteroid and/or alternative onto our products. So I'd say we don't have the data to put in front of you quite yet in terms of the exact monotherapy combination or combination percentages, but monotherapy would be – to based on my knowledge, the most common use case.

    現在請記住,生物製劑和全身使用僅佔整個市場的一小部分。因此,大約 20% 之間的任何地方,最多 25% 的患者是全身性的,這將代表最大的聯合使用,但單一療法主要是人們來自局部皮質類固醇和/或替代我們產品的情況。所以我想說,就確切的單一療法組合或組合百分比而言,我們還沒有數據可以擺在你面前,但單一療法是——根據我的知識,最常見的用例。

  • Scott L. Burrows - CFO & Principal Accounting Officer

    Scott L. Burrows - CFO & Principal Accounting Officer

  • We’re talking about AD gross to net.

    我們談論的是廣告總淨值。

  • Kenneth A. Lock - Chief Commercial Officer

    Kenneth A. Lock - Chief Commercial Officer

  • No. We expect AD gross to net trends to come on with coverage. Sorry, I thought that was a question Scott. So I'm sorry, the question regarding AD, gross to net. So one of the things as we're negotiating and you'll see is that we do expect, with some payers, obviously, synergistic relationships between current coverage for psoriasis and future indications. So while not consistent across every payer within each agreement, there are stipulations in which, in some cases, the assets would transpose onto the next indication, but other instances would require new negotiations.

    不會。我們預計 AD 總收入與淨收入的趨勢會隨著覆蓋面的增加而出現。抱歉,我認為這是 Scott 的問題。所以我很抱歉,關於 AD 的問題,從粗到淨。因此,我們正在談判並且您會看到的一件事是,我們確實期望與一些付款人顯然在當前的銀屑病覆蓋範圍和未來適應症之間存在協同關係。因此,雖然每個協議中的每個付款人並不一致,但有一些規定,在某些情況下,資產將轉移到下一個適應症,但其他情況則需要新的談判。

  • Now that being said, one of the benefits of those coming downstream of psoriasis and having done the legwork going into the psoriasis launch is that the familiarity and some of the clinical performance of the product are already understood. And so a lot of that time being spent kind of socializing that with payers, demonstrating the value proposition, et cetera, we'll have already been accomplished, and then we'll be talking about sort of the new indication. So I expect there should be some truncating of that overall lead time as we move from indication to indication.

    話雖這麼說,那些進入牛皮癬下游並完成牛皮癬發布前的工作的人的好處之一是已經了解了該產品的熟悉度和一些臨床性能。因此,很多時間都花在了與付款人的社交上,展示了價值主張,等等,我們已經完成了,然後我們將討論某種新的適應症。因此,我希望隨著我們從一個指示轉移到另一個指示,總的提前期應該會有所縮短。

  • Operator

    Operator

  • And our next question coming from the line of Seamus Fernandez from Guggenheim.

    我們的下一個問題來自古根海姆的 Seamus Fernandez。

  • Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

    Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

  • Just wanted to get a better sense of, obviously, congratulations on bringing forward an additional contract. It sounds like gross to net from the trajectory over the balance of this year is going to improve substantially quarter-to-quarter.

    只是想更好地了解,顯然,祝賀你提出一份額外的合同。從今年餘下的軌跡來看,毛淨值似乎將逐季大幅改善。

  • Just wondering, if there will also potentially from your perspective, be a bit of a release in prescribing capacity as physicians really write scripts for ZORYVE as the confidence improves that with each script written, they've got kind of a 2/3 chance of having a fully reimbursed prescription. Just wanted to get a general sense of that.

    只是想知道,從您的角度來看,是否也有可能在處方能力上有所釋放,因為醫生真的為 ZORYVE 編寫腳本,因為隨著編寫的每個腳本的信心提高,他們有 2/3 的機會有全額報銷的處方藥。只是想大致了解一下。

  • And then incremental to that, just would love to know how you're thinking about the trajectory of the business, particularly with regard to seborrheic dermatitis and how the new foam formulation is likely to slot into those coverage opportunities.

    然後是增量,只是想知道你是如何考慮業務軌蹟的,特別是在脂溢性皮炎方面,以及新的泡沫配方如何可能進入這些覆蓋範圍的機會。

  • Kenneth A. Lock - Chief Commercial Officer

    Kenneth A. Lock - Chief Commercial Officer

  • I think both of those are for me, right? So I'll start with the sort of confidence and kind of the 2/3 or 60% shot which I like that thinking. So we would expect, as coverage improves to obviously be capitalizing on this through targeted messaging to the offices in which those patients -- where those patients reside, we do know kind of geographically where these plans and PBMs impact. And so we're able to target those offices and make sure that they're aware of these updates.

    我想這兩個都適合我,對吧?所以我將從我喜歡那種想法的那種自信和那種 2/3 或 60% 的投籃開始。因此,我們預計,隨著覆蓋率的提高,顯然可以通過向這些患者所在的辦公室發送有針對性的消息來利用這一點——這些患者所在的辦公室,我們確實知道這些計劃和 PBM 影響的地理區域。因此,我們能夠針對這些辦公室並確保他們了解這些更新。

  • I think in the big picture, you're absolutely right, which is as you're writing the more you write, the more you get kind of covered the confidence sort of builds upon itself, and that's the intent when we talked about the idea of sort of the faster and better coverage leading to ultimate conversion is one has to have that sort of underlying confidence with respect to, if I'm going to do this, is it worth my time and is the patient going to end up on the therapy.

    我認為從大局來看,你是絕對正確的,當你寫的越多,你就越有信心建立在自己身上,這就是我們談論這個想法的意圖一種更快更好的覆蓋導致最終轉化的一種方式是必須有那種潛在的信心,如果我要這樣做,是否值得我花時間,病人是否會最終接受治療治療。

  • And so that is the sentiment, and we would expect that to improve I think I would say 2/3 is probably more of a tipping point than 1/3 with respect to having just one onboard previously. And I would expect that should help in terms of really changing the habits that we see. And ultimately, when we do achieve our access goals of bringing on kind of all 3 major payers, the messaging will be just that, which is have confidence with this doctor in terms of writing and you're very likely to get it if your patient is commercially insured, not to mention the fact that for our uninsured patients, we do have a program as well.

    這就是情緒,我們希望這種情況有所改善,我想我會說 2/3 可能比之前只有一個船員的 1/3 更像是一個轉折點。我希望這有助於真正改變我們所看到的習慣。最終,當我們確實實現了引入所有 3 個主要付款人的訪問目標時,信息就是這樣,這就是對這位醫生在寫作方面有信心,如果你的病人,你很可能會得到它有商業保險,更不用說對於我們沒有保險的患者,我們也有一個計劃。

  • So we're trying to really take that pressure off the decision-making in terms of thinking about that as almost a criteria for writing, it really should be kind of second nature just like it is a topical corticosteroids. So that would be the desired state with respect to what we're seeing. So I do believe that the confidence will start building and thus the pace.

    所以我們試圖真正減輕決策的壓力,將其視為寫作的標準,它真的應該是一種第二天性,就像它是一種外用皮質類固醇一樣。因此,就我們所看到的而言,這將是理想的狀態。所以我相信信心會開始建立,因此步伐也會加快。

  • Todd Franklin Watanabe - President, CEO & Director

    Todd Franklin Watanabe - President, CEO & Director

  • I think -- this is Frank. Just quickly, I think in addition to the 2/3 coverage, the other key piece to that is the lack of a prior authorization, right? Because if doctors are putting in prescriptions and they're getting kicked back from the pharmacies for additional paperwork, that's not as bad as a denial, but it certainly adds to the friction and having obtained coverage now for 2 of the 3 big PBMs without a prior authorization, I think, will be another important facet of prescriber confidence.

    我想——這是弗蘭克。很快,我認為除了 2/3 的覆蓋範圍之外,另一個關鍵因素是缺乏事先授權,對吧?因為如果醫生開了處方,他們被藥房踢回額外的文書工作,這並不像拒絕那麼糟糕,但它肯定會增加摩擦,並且現在已經獲得了 3 大 PBM 中的 2 家的保險而沒有我認為,事先授權將是處方者信心的另一個重要方面。

  • Kenneth A. Lock - Chief Commercial Officer

    Kenneth A. Lock - Chief Commercial Officer

  • So then pivoting back to your question regarding seb derm Seamus [ph 0:31:34]. So I think a couple of things in play here. So recognizing that the population of patients and sort of skews older, it invokes a slightly different insurance mix, right? So we're thinking about a little bit more government-pay patients, a little bit less commercial pay patients. So first and foremost, we need to be thinking about that and sort of our aspirations for government pay insurance types.

    那麼回到你關於 seb derm Seamus [ph 0:31:34] 的問題。所以我認為這裡有幾件事在起作用。因此,認識到患者人數和年齡偏大,它會調用一種略有不同的保險組合,對吧?所以我們正在考慮多一點政府支付的患者,少一點商業支付的患者。因此,首先,我們需要考慮這一點以及我們對政府支付保險類型的期望。

  • I think the second thing is that, as I mentioned to Vikram, we should assume that there will be some carryover or transposition of some of our coverage, so to speak, into seb derm, However, just as we think about government pay and securing things like Medicare coverage, in general, the rebid expectations are higher than that of commercial pay. So I'm not 100% sure quite yet how that will play out. It's obviously going to be a mix in terms of overall gross to net.

    我認為第二件事是,正如我對 Vikram 提到的,我們應該假設我們的某些保險範圍會有一些結轉或轉移,可以這麼說,進入 seb derm,但是,正如我們考慮政府支付和保障像 Medicare 保險這樣的東西,一般來說,再投標的預期要高於商業薪酬。所以我還不能 100% 確定結果會怎樣。就總體毛淨額而言,這顯然是一個混合體。

  • But the price to pay, so to speak, with the government payers is typically higher than that of a commercial pay. But however, in seb derm overall, from a net perspective -- I'm sorry, from a total competition standpoint, it's still majority commercial, but the percentage of government pay is about, let's call it, 45% versus what we see in something like a psoriasis, which is about 1/3. Olivia, can we go to the next one?

    但可以說,政府付款人支付的價格通常高於商業支付的價格。但是,然而,在整個 seb derm 中,從淨角度來看——對不起,從總體競爭的角度來看,它仍然主要是商業性的,但政府支付的百分比大約是,我們稱之為 45%,而我們在有點像牛皮癬,大約是 1/3。奧利維亞,我們可以去下一個嗎?

  • Operator

    Operator

  • Our next question coming from the line of Ken Cacciatore with Cowen.

    我們的下一個問題來自 Ken Cacciatore 與 Cowen 的對話。

  • Kenneth Charles Cacciatore - MD & Senior Research Analyst

    Kenneth Charles Cacciatore - MD & Senior Research Analyst

  • Congratulations on all the progress. I know just Frank and Ken, stepping back, there's many ways to launch a drug, and I know there's multiple ways to be successful in it. But can you talk about some of the differences from your perspective on how you're approaching this? And you're giving very detailed, but maybe you could juxtapose that against your competitor because unfortunately, on Wall Street, especially when we're nearly simultaneously launching products, you get compared in terms of the Rx and the trajectory of your launch and their launch.

    祝賀所有的進步。我只知道弗蘭克和肯,退一步說,有很多方法可以推出一種藥物,而且我知道有多種方法可以成功。但是你能從你的角度談談你是如何處理這個問題的一些不同之處嗎?你提供了非常詳細的信息,但也許你可以將其與你的競爭對手並列,因為不幸的是,在華爾街,尤其是當我們幾乎同時推出產品時,你會根據 Rx 和你的發布軌跡以及他們的產品進行比較發射。

  • But maybe you could bring out some of the subtle nuances to your approach and why we seem to be sticking with it and ultimately, why we're going to be successful. And I'll say one thing before you answer. We have done a lot of doc checks, and I just need to say exactly mirroring what you're hearing. They definitely are giving us great feedback on the product. But with that, I'll let you answer that question.

    但也許你可以提出你的方法的一些細微差別,以及為什麼我們似乎堅持它,最終,為什麼我們會成功。在你回答之前我要說一件事。我們已經做了很多文件檢查,我只需要準確地反映你所聽到的。他們肯定給了我們很好的產品反饋。但是有了這個,我會讓你回答這個問題。

  • Kenneth A. Lock - Chief Commercial Officer

    Kenneth A. Lock - Chief Commercial Officer

  • Sure, Ken. I'll take a stab at that. So thanks for teeing it up. Obviously, to the naked eye, I think the trajectories look very different. And I think we've said in the past that we're comfortable with the sort of a steady progression that's focused on disciplined financials. We aren't subduing, if you will, any of the prescriptions by sort of putting out temporary offers or buy-downs, which then kind of -- I think I read recently, there was a comment about when the honeymoon period ends, right?

    當然,肯。我會嘗試一下。所以謝謝你準備好了。顯然,肉眼看來,軌跡看起來非常不同。我認為我們過去曾說過,我們對專注於紀律嚴明的財務狀況的穩步發展感到滿意。如果你願意,我們不會通過提供臨時報價或回購來製服任何處方,然後有點——我想我最近讀到,有一條關於蜜月期何時結束的評論,對吧?

  • So when companies start pulling back their introductory offers and some of the reality set in. So we've typically -- we've generally refrained from kind of going out with offers that are too good to believe or too good to be true, very typically, those tend to be sustainable and then start morphing. And then actually, that only works in one direction, which is to disappoint your customers and your patients. So we want to keep that sustained sort of approach in a disciplined way. That's why you're seeing the trajectory that you're seeing. And it's not, again, like boosted by kind of artificial instruments or anything that would make that look the way it looks. So those are fundamental differences in terms of that.

    因此,當公司開始撤回他們的介紹性報價時,一些現實就會出現。所以我們通常 - 我們通常會避免提供好得令人難以置信或好得令人難以置信的報價,非常通常,那些往往是可持續的,然後開始變形。然後實際上,這只會在一個方向上起作用,那就是讓您的客戶和患者失望。因此,我們希望以一種有紀律的方式保持這種持續的方法。這就是為什麼你看到你所看到的軌跡。再次強調,這不像是通過某種人造儀器或任何可以使它看起來像它的樣子的東西來增強。因此,就此而言,這些是根本差異。

  • And the second thing is that with this sort of disciplined approach and, of course, our pricing coming into play, you would expect then the type of -- the velocity at which we're getting our coverage to ultimately be the sort of throttle or the rate limiter on kind of how we take off in the market. So I get the question a lot, "Hey, are you going to see an inflection all of a sudden based on getting coverage. The short answer is no, because with coverage, it takes time, obviously, for those patients to work their way back into the offices. They're not all sort of waiting to rush in the second we get coverage. So I would anticipate the trajectory to kind of continue to grow and build steadily.

    第二件事是,通過這種有紀律的方法,當然還有我們的定價發揮作用,你會期望我們獲得報導的速度最終會成為一種節流閥或我們如何在市場上起飛的速率限制器。所以我經常收到這樣的問題,“嘿,你會不會因為獲得保險而突然看到一個拐點?簡短的回答是否定的,因為有了保險,這些病人顯然需要時間才能按照自己的方式工作回到辦公室。他們並沒有在我們得到報導的那一刻就等著衝進去。所以我預計軌跡會繼續增長並穩步建立。

  • And importantly, the type of access that we have, which is hopefully as easy as possible for physicians such that it's, again, as easy to or sort of second nature to write our product. That's what I believe we'll continue our sustained growth. So those are some of the key differences I would say, with respect to kind of how we're doing things. And we intend to sort of keep those offers that we have in the market, sort of steady, sustainable, predictable, I think these are very important for the credibility of both the company as well as the physician who ends up kind of articulating this to a patient because coming back 3 weeks later and saying, well, I thought it was this and it's not that. That's something that I think is it's a great deal of frustration and the offices and at the patient level, that's not what we're doing.

    重要的是,我們擁有的訪問類型,希望這對醫生來說盡可能簡單,這樣,編寫我們的產品同樣容易或成為第二天性。這就是我相信我們將繼續持續增長的原因。因此,關於我們做事的方式,這些是我要說的一些關鍵差異。我們打算在某種程度上保持我們在市場上的報價,穩定的、可持續的、可預測的,我認為這些對公司和最終闡明這一點的醫生的信譽都非常重要一個病人,因為 3 週後回來說,好吧,我以為是這個而不是那個。我認為這是一件令人沮喪的事情,在辦公室和患者層面,這不是我們正在做的事情。

  • Todd Franklin Watanabe - President, CEO & Director

    Todd Franklin Watanabe - President, CEO & Director

  • Yes. Ken, good to hear from you. The only thing I would add, I think, is beyond the access piece that Ken talked about. We talked about the product profile. I think it's critical that early clinical experience with the product be consistent with what the doctor and the patient have been told, right? The efficacy needs to be consistent with the data and the tolerability and safety needs to be consistent with the data. And I would say that what we have heard and I think what you and some of the analysts have also heard from your doctor (inaudible) is that ZORYVE is matching up to those expectations in terms of both efficacy and tolerability. And we think that, that's really building a solid foundation. You know from your many years in the field, when doctors are disappointed or patients are disappointed with their experience with a product that can very quickly turn the sentiment on a product, and we've seen any number of examples of that in the past. So we think it's critical that the product is delivering on the promise, and that's what we're hearing from our customers.

    是的。肯,很高興收到你的來信。我認為,我唯一要補充的是 Ken 談到的訪問部分之外的內容。我們談到了產品概況。我認為產品的早期臨床經驗與醫生和患者被告知的一致是至關重要的,對吧?療效需要和數據一致,耐受性和安全性需要和數據一致。我想說的是,我們所聽到的,我想你和一些分析師也從你的醫生那裡聽到的(聽不清)是 ZORYVE 在療效和耐受性方面符合這些期望。我們認為,這確實是在建立堅實的基礎。從您在該領域的多年經驗中,您知道當醫生或患者對他們對產品的體驗感到失望時,這種產品會很快改變人們對產品的看法,過去我們已經看到過很多這樣的例子。因此,我們認為產品兌現承諾至關重要,而這正是我們從客戶那裡聽到的。

  • Operator

    Operator

  • And our next question coming from the line of Gregory Fraser with Truist.

    我們的下一個問題來自 Gregory Fraser with Truist。

  • Gregory Daniel Fraser - Research Analyst

    Gregory Daniel Fraser - Research Analyst

  • Congrats on progress. The conversion analogs that you discussed are notable not just for the uptake of the new differentiated class, but also for overall market growth. Do you see the potential for significant volume growth for the topical psoriasis market is or even other nonsteroidal gain traction or do you think the dynamics for the psoriasis market will be more about conversion from steroids and not necessarily significant growth in topical psoriasis [ph]?

    祝賀進步。您討論的轉換類似物不僅在新的差異化類別的採用方面引人注目,而且在整體市場增長方面也很引人注目。您是否認為局部牛皮癬市場或什至其他非類固醇獲得牽引力的顯著銷量增長潛力,或者您是否認為牛皮癬市場的動態將更多地與類固醇的轉化有關,而不一定是局部牛皮癬 [ph] 的顯著增長?

  • Todd Franklin Watanabe - President, CEO & Director

    Todd Franklin Watanabe - President, CEO & Director

  • Certainly, I think there's an opportunity for growth in the market from a couple of aspects. The first one is, if you look at the epidemiology, there are clearly a lot of patients who are not currently on prescription treatment. And that may be a variety of reasons, lack of insurance coverage. But we know that one of those factors is frustration with existing treatment choices. And so having a product like ZORYVE out there that is efficacious is safe and well tolerated and is readily available may bring some of those patients back off of their couches and back into the dermatologist office.

    當然,我認為市場有幾個方面的增長機會。第一個是,如果你看看流行病學,顯然有很多患者目前沒有接受處方治療。這可能是多種原因,缺乏保險範圍。但我們知道,其中一個因素是對現有治療選擇感到沮喪。因此,擁有像 ZORYVE 這樣有效且安全且耐受性良好且易於獲得的產品,可能會讓一些患者從沙發上回來,回到皮膚科醫生辦公室。

  • I think the other thing is that topical steroids are very effective in treating plague psoriasis, but they can't really be used chronically safely. And so there's a natural limit on consumption of topical steroids and the non-steroid alternatives historically have not been very effective nor have they been very well tolerated. So having a drug that's as efficacious and is safe and well tolerated as here, there may be some opportunity for volume growth even amongst existing patients based on that as well.

    我認為另一件事是局部類固醇在治療鼠疫牛皮癬方面非常有效,但它們不能真正安全地長期使用。因此,外用類固醇的消耗存在自然限制,非類固醇替代品歷來不是很有效,也沒有很好的耐受性。因此,擁有一種像這裡一樣有效、安全且耐受性良好的藥物,即使在現有患者中也可能有一些增長的機會。

  • I think -- sorry, I think the other point I would make, too, is that outside of psoriasis, I think as we add these additional indications as well, those are further opportunities to grow the overall opportunity for non-steroidals. Ken, do you have any additional thoughts or Patrick.

    我想 - 抱歉,我想我還要提出的另一點是,在牛皮癬之外,我認為當我們也添加這些額外的適應症時,這些是增加非甾體類藥物整體機會的進一步機會。肯,你還有什麼其他想法嗎?帕特里克。

  • Kenneth A. Lock - Chief Commercial Officer

    Kenneth A. Lock - Chief Commercial Officer

  • No.

    不。

  • Patrick E. Burnett - Senior VP & Chief Medical Officer

    Patrick E. Burnett - Senior VP & Chief Medical Officer

  • No.

    不。

  • Todd Franklin Watanabe - President, CEO & Director

    Todd Franklin Watanabe - President, CEO & Director

  • Maybe can we move to the next question?

    也許我們可以轉到下一個問題?

  • Operator

    Operator

  • Our next question coming from the line of Louise Chen with Cantor.

    我們的下一個問題來自 Louise Chen 與 Cantor 的對話。

  • Louise Alesandra Chen - Senior Research Analyst & MD

    Louise Alesandra Chen - Senior Research Analyst & MD

  • So first question I have for you is, how do you think the uptake for atopic dermatitis, if approved, will be compared to what you see for psoriasis and why? And then secondly, what do you think the read through is from the adult psoriasis data -- sorry, the adult AD data to the pediatric AD data? How should we think about that? And then last question is just thinking about the potential competitive advantages of ARQ-234 and when that might enter the clinic?

    所以我要問你的第一個問題是,如果獲得批准,你如何看待特應性皮炎的吸收與你所看到的牛皮癬的吸收,為什麼?其次,您認為從成人銀屑病數據中讀出什麼——抱歉,成人 AD 數據到兒科 AD 數據?我們應該如何考慮?最後一個問題是考慮 ARQ-234 的潛在競爭優勢以及它何時可能進入臨床?

  • Todd Franklin Watanabe - President, CEO & Director

    Todd Franklin Watanabe - President, CEO & Director

  • So I'm going to take the first one, and then I'll ask Patrick to talk about the AD read through than the 234 question. So I think that with regard to uptake, I think there certainly is a potential that atopic dermatitis could have a faster uptake for a couple of reasons. The first one is, as Ken mentioned, there could be some acceleration in access decisions for atopic dermatitis just based on psoriasis. The second one is, we have the advantage that doctors are going to have a great deal of familiarity with topical roflumilast when we get the approval in atopic dermatitis.

    所以我要拿第一個,然後我會請帕特里克談談 AD 通讀而不是 234 問題。所以我認為關於吸收,我認為特應性皮炎肯定有可能由於幾個原因而有更快的吸收。第一個是,正如 Ken 提到的,僅基於牛皮癬的特應性皮炎的訪問決策可能會有所加速。第二個是,當我們獲得特應性皮炎的批准時,我們的優勢在於醫生將非常熟悉外用羅氟司特。

  • And I think that's particularly important because we know that when we launched ZORYVE, there was a certain degree of skepticism about topical PDE4s based on prior experience with the other topical PDE4 inhibitor. And it's taken doctors a little while to dispel some of those anxieties. None of that will be an obstacle to the adoption in atopic dermatitis. And so I think when you pull all of those together, we certainly could see a faster initial uptake in atopic dermatitis. Ken, any other thoughts from your side? And then -- so Patrick, can you maybe talk about the read through from INTEGUMENT-1 and 2 to INTEGUMENT-PED then ARQ-234 and some of its advantages in the clinic?

    我認為這特別重要,因為我們知道,當我們推出 ZORYVE 時,根據之前使用其他外用 PDE4 抑製劑的經驗,人們對外用 PDE4 存在一定程度的懷疑。醫生花了一些時間才消除了其中的一些焦慮。這些都不會成為在特應性皮炎中採用的障礙。所以我認為當你把所有這些放在一起時,我們當然可以看到特應性皮炎的初始吸收更快。肯,你還有其他想法嗎?然後——帕特里克,你能談談從 INTEGUMENT-1 和 2 到 INTEGUMENT-PED 然後是 ARQ-234 的閱讀及其在臨床上的一些優勢嗎?

  • Patrick E. Burnett - Senior VP & Chief Medical Officer

    Patrick E. Burnett - Senior VP & Chief Medical Officer

  • Yes. With regard to the read through from INTEGUMENT-1 and INTEGUMENT-2 to the INTEGUMENT-PED trial, keep in mind that 1 and 2 enrolled patients ages 6 and above and the INTEGUMENT-PED trial is ages 2 to 5. I think that reading out 2 successful Phase III studies in atopic dermatitis, where we're not really seeing within our data or looking across other data in atopic dermatitis, a really significant difference in how patients are responding based on their age and especially considering the fact that INTEGUMENT-1 and 2 included a lot of pediatric patients from the ages of 6 all the way up and including adolescents up to the age of 17. So we're seeing a very strong read through from INTEGUMENT-1 and 2 over to the pediatric trial that we're planning to read out in the second half of this year.

    是的。關於從 INTEGUMENT-1 和 INTEGUMENT-2 到 INTEGUMENT-PED 試驗的通讀,請記住 1 和 2 登記的患者年齡在 6 歲及以上,而 INTEGUMENT-PED 試驗是 2 到 5 歲。我認為閱讀在特應性皮炎的 2 項成功的 III 期研究中,我們並沒有真正在我們的數據中看到或查看特應性皮炎的其他數據,根據患者的年齡,患者的反應方式確實存在顯著差異,特別是考慮到 INTEGUMENT- 1 和 2 包括很多 6 歲以上的兒科患者,包括 17 歲以下的青少年。所以我們看到從 INTEGUMENT-1 和 2 到兒科試驗的非常有力的閱讀我們計劃在今年下半年宣讀。

  • With regard to 234, we haven't released any time lines with regard to that program right now. We'll probably be in a place later this year to say a little bit more about them. But we do see based off of just the mechanism of action of CD200R as well as some of the clinical data that's out there, not with ours with another CD200R agonist. What we're seeing is that we're seeing the potential ability of these of this pathway to have an extended effect on the immune system, not specifically by suppressing the immune system, but by adjusting the response so that it's targeting specifically those pathways that may have been activated.

    關於 234,我們目前尚未發布有關該計劃的任何時間表。我們可能會在今年晚些時候在某個地方多談一些關於他們的事情。但我們確實看到了 CD200R 的作用機制以及一些現有的臨床數據,而不是我們的另一種 CD200R 激動劑。我們所看到的是,我們正在看到該通路中的這些通路對免疫系統產生長期影響的潛在能力,不是特別通過抑制免疫系統,而是通過調整反應,使其專門針對那些通路可能已被激活。

  • And in the case of diseases like atopic dermatitis, these are pathways that would have been activated, not in response to a signal that needs to be managed, but more kind of pathologically activated is the potential to be able to have a more long-term response than what you might be seeing with IL-4 and 13, which needs to be dosed quite frequently as well as an ability maybe to manage this disease without creating any kind of immune suppression. So these are some of the aspects of CD200R that made it very interesting to us, and we're looking forward to giving you more information about that program as we progress it internally.

    在特應性皮炎等疾病的情況下,這些途徑本來會被激活,而不是響應需要管理的信號,但更多的病理激活是有可能有更長期的反應比你可能看到的 IL-4 和 13 的反應要高,IL-4 和 13 需要非常頻繁地給藥,並且可能在不產生任何免疫抑制的情況下控制這種疾病。因此,這些是 CD200R 的一些方面,讓我們對它非常感興趣,我們期待在我們內部推進該程序時為您提供更多有關該程序的信息。

  • Operator

    Operator

  • (Operator Instructions) And our next question. And our next question coming from the line of Rohit Besson [ph] with Miham & Company ph .

    (操作員說明)我們的下一個問題。我們的下一個問題來自 Rohit Besson [ph] 和 Miham & Company ph 的台詞。

  • Unidentified Analyst

    Unidentified Analyst

  • This is Rohan on for (inaudible). Can you talk about any particular trends you're seeing in terms of new Rxs versus refills? And then in terms of the OpEx, I know you mentioned you expect SG&A to increase, but can you provide any additional color there?

    這是 Rohan(聽不清)。你能談談你在新 Rxs 與筆芯方面看到的任何特定趨勢嗎?然後就 OpEx 而言,我知道你提到你希望 SG&A 增加,但你能提供任何額外的顏色嗎?

  • Unidentified Company Representative

    Unidentified Company Representative

  • Sure, Rohit. So I think you probably are seeing the same trends as we are. NRx remains strong. And one of the things that's tricky about TRx is because this is a chronic condition in the topical space though, the therapy seems to be used acutely, and that's why we see kind of overall expectations for adherence to be in the neighborhood of 3 to 4. So it was a little bit tricky to see kind of patients are continuously using because they're coming in at all different levels of clarity and all different levels of body surface area. I will say though, we are seeing positive trends with respect to some patients coming back for tubes, 3 and 4 already.

    當然,羅希特。所以我認為您可能看到了與我們相同的趨勢。 NRx 仍然堅挺。 TRx 的棘手之處之一是,儘管這是局部領域的慢性病,但該療法似乎被敏銳地使用,這就是為什麼我們看到對依從性的總體期望在 3 到 4 左右. 因此,看到一些患者持續使用有點棘手,因為他們的清晰度和體表面積各不相同。不過,我要說的是,我們已經看到一些患者返回接受試管 3 和 4 的積極趨勢。

  • So certainly, a good sign with respect to overall patient satisfaction and adherence. But the ratios, if you will, that you can kind of see them in the weeklies are pretty representative of what's happening. What I'm enthused about is that our NRx trends appear to be quite strong. And again, the TRxs the refills that are sporadic because it's not a 1:1. -- a patient might pick up a refill now for our prescription they got in August, for example. So it's a little bit trickier there. But the NRx trends for us, I think, look good and the more awareness and confidence that the community builds additionally with the additional coverage, I would expect that to continue to grow.

    因此,對於患者的總體滿意度和依從性而言,這無疑是一個好兆頭。但是,如果你願意的話,你可以在周報中看到它們的比率非常能代表正在發生的事情。令我興奮的是,我們的 NRx 趨勢似乎非常強勁。再一次,TRxs 是零星的筆芯,因為它不是 1:1。 -- 例如,患者現在可能會為他們在 8 月份拿到的處方藥取藥。所以那裡有點棘手。但我認為,對我們而言,NRx 趨勢看起來不錯,並且社區通過額外的覆蓋範圍建立更多的意識和信心,我預計它會繼續增長。

  • Scott L. Burrows - CFO & Principal Accounting Officer

    Scott L. Burrows - CFO & Principal Accounting Officer

  • Yes. And then a question on SG&A trajectory. I would say that we're still obviously quite early in the launch of psoriasis. You can expect that to grow a little bit as we bring on new sales and marketing tactics over time. And then importantly, we just had our NDA accepted a couple of weeks ago for seborrheic dermatitis. And so we want to make sure we're well prepared for that launch. So we'll be investing ahead of that launch that could come as early as late this year or early next year. So we'll start investing in the launch there.

    是的。然後是關於 SG&A 軌蹟的問題。我想說的是,我們顯然還處於牛皮癬的早期階段。隨著我們隨著時間的推移引入新的銷售和營銷策略,您可以期待它會有所增長。然後重要的是,幾週前我們剛剛接受了脂溢性皮炎的 NDA。因此,我們要確保我們為這次發布做好了充分準備。因此,我們將在最早可能在今年年底或明年初推出的產品之前進行投資。所以我們將開始投資那裡的發射。

  • Operator

    Operator

  • And our next question coming from the line of Uy Ear with Mizuho Group.

    我們的下一個問題來自 Uy Ear 與瑞穗集團的合作。

  • Uy Sieng Ear - VP

    Uy Sieng Ear - VP

  • I was wondering, I think you guys indicated that there's some 4,000 physicians that have already run prescription. Just curious to know, how many physicians have your sales reps reach out to? And yes, so that's the -- and I guess, why what would it take for the rest of these physicians to write a prescription. And the second question I have is, could you help characterize the opportunity for plaque psoriasis in pediatrics, I guess? And would you need -- would you launches on your own? Or do you think you need a partner?

    我想知道,我想你們表示已經有大約 4,000 名醫生開了處方。只是想知道,您的銷售代表聯繫了多少醫生?是的,這就是——我想,為什麼其他這些醫生需要什麼才能開出處方。我的第二個問題是,你能幫助描述兒科斑塊狀銀屑病的機會嗎?你會需要——你會自己發射嗎?或者你認為你需要一個合作夥伴?

  • Scott L. Burrows - CFO & Principal Accounting Officer

    Scott L. Burrows - CFO & Principal Accounting Officer

  • Sure, Uy. So let's first start with the 4,000 vis-a-vis the targeted. So at this point, we think of the target universe in total between 12,000 and 13,000 physicians are targeted. We've reached or spoken to about 10,000 of those thus far. And so gaining momentum in both awareness as well as trial. As for the specifics of why they would or wouldn't -- I can't pinpoint exactly those reasons. Obviously, sometimes we need to reach out to them several times in a row where they need to get some additional confidence one direction or another, whether clinically, from a colleague, by patient request ultimately kind of seeing or reading about the product a little bit more. But it takes several cycles.

    當然,Uy。因此,讓我們首先從目標 4,000 開始。所以在這一點上,我們認為目標宇宙總共有 12,000 到 13,000 名醫生是目標。到目前為止,我們已經接觸或與其中大約 10,000 人進行了交談。因此在意識和試驗中都獲得了動力。至於他們願意或不願意的具體原因——我無法準確指出這些原因。顯然,有時我們需要連續多次聯繫他們,他們需要從一個方向或另一個方向獲得一些額外的信心,無論是臨床上的,從同事那裡,根據患者的要求,最終有點看到或閱讀有關產品的信息更多的。但是需要幾個週期。

  • In other words, one conversation is typically not enough to get a prescription to secured. We obviously are driving as hard as we can, and we continue to look to evaluate other instruments to improve our reach and more importantly, our frequency of those physicians. So that's all I can really say. I don't really know sort of the absolute by physician [ph] reasons. But for those that have adopted, clearly, they've adopted robustly, and we're happy to see that.

    換句話說,一次對話通常不足以確保獲得處方。顯然,我們正在盡我們所能地努力駕駛,並且我們將繼續尋求評估其他工具以提高我們的覆蓋範圍,更重要的是,我們會增加這些醫生的頻率。所以這就是我真正能說的。我真的不知道醫生 [ph] 的絕對原因。但對於那些已經採用的人來說,很明顯,他們已經堅定地採用了,我們很高興看到這一點。

  • On the second question, you mentioned the -- I think the pediatric psoriasis opportunity, is that what you were asking? So that opportunity remains to be -- it's pretty small actually in terms of absolute prevalence, sort of single-digit percentage prevalence for that group. And so first and foremost, we wouldn't be looking to expand into pediatrics as a result of this particular opportunity? What this confers for us is really an additional halo or additional sort of confidence signal in terms of the safety profile of the product.

    關於第二個問題,你提到了——我認為小兒牛皮癬的機會,這是你要問的嗎?所以這個機會仍然存在——就絕對流行率而言,它實際上很小,該群體的個位數百分比流行率。因此,首先,我們不會因為這個特殊機會而尋求擴展到兒科領域?就產品的安全性而言,這實際上給我們帶來了額外的光環或額外的信心信號。

  • As with, for example, other like biologics and such typically, you see that with psoriasis, well they'll go all the way down to 2, recognizing that, really, that's more of a marker and sign a signal of safety than it is a sort of absolute market opportunity. Where we would do that, obviously, for atopic dermatitis with the sort of the prevalence of that is significantly higher in pediatrics and we've spoken before about how we would do that, which is largely through a partnership mechanism with a company that would have a footprint in pediatrics already. I don't know that we would expand our team that much because it's a very large footprint to get into primary care.

    例如,與其他類似生物製劑等典型情況一樣,您會看到牛皮癬,它們會一直下降到 2,認識到,實際上,這更像是一個標記,比它更安全一種絕對的市場機會。顯然,對於特應性皮炎,我們會在哪裡做這件事,這種病在兒科的患病率要高得多,我們之前已經說過我們會怎麼做,這主要是通過與一家公司的合作機制已經在兒科領域留下了足跡。我不知道我們會擴大我們的團隊那麼多,因為進入初級保健需要很大的空間。

  • Todd Franklin Watanabe - President, CEO & Director

    Todd Franklin Watanabe - President, CEO & Director

  • I might just add with regard to the pediatric psoriasis topic, it is a small population, but there are very, very few options for those patients -- approved options for young children. Most products aren't even approved on the 12, which is what we're currently proved down to. And one of the things that we've talked about in the past with the investment community was that our decision to study – to read down to the age of 2 was actually at the best of the FDA, I think, which was probably a reflection of their confidence in the safety of PDE4 as a target. They really encouraged us to study this down to the age of 2, and we agreed because we felt that it was an important question to answer and important data for doctors to have, which is what led us to do it even though we knew it would not be a large source of business for us.

    關於小兒牛皮癬的話題,我可能只是補充一下,它的人口很少,但這些患者的選擇非常非常少——已批准的適合幼兒的選擇。大多數產品甚至在 12 日都沒有獲得批准,這正是我們目前所證明的。我們過去與投資界討論過的一件事是,我們決定學習 - 閱讀到 2 歲實際上是 FDA 的最佳選擇,我認為,這可能是反映了他們對 PDE4 作為目標的安全性的信心。他們真的鼓勵我們研究這個直到 2 歲,我們同意了,因為我們覺得這是一個需要回答的重要問題,也是醫生需要擁有的重要數據,這就是促使我們這樣做的原因,即使我們知道它會對我們來說不是一個大的業務來源。

  • Operator

    Operator

  • Thank you. And I'm showing no further questions at this time. I would now like to turn the call back over to Mr. Frank Watanabe for any closing remarks.

    謝謝。我現在沒有進一步提問。現在,我想將電話轉回給 Frank Watanabe 先生,聽取任何結束語。

  • Todd Franklin Watanabe - President, CEO & Director

    Todd Franklin Watanabe - President, CEO & Director

  • Okay. So let me first off, thank everyone on the Arcutis team. '22, as I think you all have seen was an exceptional year. That didn't happen by chance, there was a huge amount of work done by what I think is just a phenomenal team of individuals, and I'm delighted to be working with each and every one of them. And secondly, I want to thank our investors for continuing to support us. And then lastly, I want to thank all of you for joining in on the call today. So with that, we look forward to talking to you all in another 3 months.

    好的。首先,讓我感謝 Arcutis 團隊的每一個人。 22 年,我認為你們都看到了非凡的一年。這不是偶然發生的,我認為這只是一個非凡的個人團隊完成了大量的工作,我很高興能與他們中的每一個人一起工作。其次,我要感謝我們的投資者繼續支持我們。最後,我要感謝大家參加今天的電話會議。因此,我們期待在接下來的 3 個月內與大家交談。

  • Operator

    Operator

  • Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.

    女士們,先生們,我們今天的會議到此結束。感謝您的參與。您現在可以斷開連接。