Arcutis Biotherapeutics Inc (ARQT) 2023 Q3 法說會逐字稿

Good day and welcome to the Arcutis Biotherapeutics Third-Quarter 2023 earnings conference call. (Operator Instructions)

美好的一天，歡迎參加 Arcutis Biotherapeutics 2023 年第三季財報電話會議。 （操作員說明）

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Eric McIntyre, Head of Investor Relations. Please go ahead.

請注意，今天的會議正在錄製中。現在，我想將會議交給今天的發言人，投資者關係主管 Eric McIntyre。請繼續。

Thank you, Abigail, good morning everyone, and thank you for joining us this morning to discuss our Q3 2023 financial results. Slides for today are available on the Investors section of our website. On the call this morning we have Frank Watanabe, President, and CEO; Todd Edwards, our Chief Commercial Officer; Patrick Burnett Chief Medical Officer, and John Smither, our Chief Financial Officer.

謝謝阿比蓋爾，大家早上好，感謝您今天早上加入我們討論我們 2023 年第三季的財務業績。今天的幻燈片可在我們網站的投資者部分找到。今天早上的電話會議有總裁兼首席執行官弗蘭克·渡邊 (Frank Watanabe) 主持。托德·愛德華茲，我們的首席商務官； Patrick Burnett 首席醫療官和 John Smither 是我們的財務長。

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

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。現在，讓我把電話轉給弗蘭克。

Thanks. Eric So I'm on slide 5 of the deck now. We're really pleased with the Arcutis team in our execution in the quarter, we made remarkable progress since last time we spoke regarding our Q2 earnings, starting off with the ZORYVE launch in psoriasis that continues to gain momentum, and we now have over 110,000 prescriptions and about 9,000 unique prescribers launched to date as our product delivers positive clinical experience for health care providers and their patients.

謝謝。艾瑞克（Eric）所以我現在在幻燈片 5 上。我們對Arcutis 團隊在本季度的執行情況感到非常滿意，自上次談論第二季度收益以來，我們取得了顯著進展，從針對銀屑病的ZORYVE 推出開始，該藥物繼續獲得勢頭，現在我們擁有超過110,000迄今為止，我們推出了約 9,000 個獨特的處方，因為我們的產品為醫療保健提供者及其患者提供了積極的臨床體驗。

This positive tailwinds sets us up to launch our future topical roflumilast formulations as well from a position of strength. We also saw significant gross net improvements in the quarter averaging in the low 70s for the quarter. Once again, we had solid execution against our clinical and regulatory milestones with a steady flow of successes this past quarter. Patrick will go in a lot more detail in his remarks, but during the quarter.

這種積極的推動力使我們能夠以優勢地位推出未來的外用羅氟司特製劑。我們也看到本季毛淨值顯著改善，平均值在 70 左右。我們再次堅定地執行了臨床和監管里程碑，並在上個季度取得了穩定的成功。帕特里克將在本季的演講中提供更多細節。

We received FDA approval for an expanded psoriasis indication down to the age of six, we filed a supplemental NDA for atopic dermatitis down to the age of six with an expected approval in early Q3 of 2024.

我們獲得 FDA 批准將銀屑病適應症擴大到 6 歲，我們提交了針對 6 歲以下異位性皮膚炎的補充 NDA，預計將於 2024 年第三季初獲得批准。

We announced positive pivotal Phase 3 data for AD in the 2-5year old range and that we really some really exciting the long-term data in AD that demonstrated efficacy continues with and actually improved with treatment with [favorable] of long term out to 52 weeks, along with a very favorable long-term safety independent of these disease control.

我們宣布了2-5 歲範圍內AD 的積極關鍵3 期數據，並且我們確實有一些非常令人興奮的AD 長期數據，這些數據表明，長期[有利] 治療的療效持續有效，並且實際上有所改善，直至52數週，以及獨立於這些疾病控制的非常有利的長期安全性。

We also have also strengthened our capital position with follow-on raise. We completed in October as well as the upfront from the out-licensing deal we executed in Huadong for Greater China and Southeast Asia, and John, will go into more details in just a minute.

我們也透過後續融資加強了我們的資本狀況。我們於 10 月完成了我們在華東針對大中華區和東南亞執行的對外許可交易的預付款，約翰將在一分鐘內詳細介紹更多細節。

John will also talk about some more positive news around positive revisions in our SLR, our debt agreement that we've recently concluded, and we expect to; we continue to expand our intellectual property estate with the receipt of a new formulation patent in October, which is already listed in the Orange Book, very importantly, and we have a number of additional pending applications that we expect that we'll issue soon and which will further build on the breadth and depth of our patent protection.

約翰也將談論有關我們的 SLR 的積極修訂的一些更積極的消息，我們最近達成的債務協議，我們預計會這樣做；非常重要的是，我們在10 月獲得了一項新配方專利，繼續擴大我們的智慧財產權範圍，該專利已被列入橙皮書，並且我們還有許多其他待決申請，我們預計很快發布這將進一步擴大我們專利保護的廣度和深度。

But moving on to slide 6, we're also very excited about 2024 as we are on the cusp of a very significant expansion of the opportunity for topical roflumilast in the coming year, which will translate into a substantial acceleration in our revenue trajectory.

但轉到幻燈片 6，我們對 2024 年也感到非常興奮，因為我們正處於明年局部羅氟司特機會大幅擴展的風口浪尖，這將轉化為我們收入軌蹟的大幅加速。

In the next 12 months, roughly, we will expand the total addressable market for ZORYVE, potentially about tenfold, expanding our patient opportunity in the US from roughly 1.3 million commercial psoriasis patients today to over 13 million patients as we add about 1.2 million patients commercial patients with seborrheic dermatitis and about 1.4 million commercial patients with atopic dermatitis treated by dermatologists following the anticipated approval for those indications.

大致而言，在接下來的12 個月內，我們將擴大ZORYVE 的總潛在市場，可能擴大十倍左右，將我們在美國的患者機會從目前的約130 萬商業銀屑病患者擴大到超過1300萬患者，因為我們增加了約120 萬名商業患者脂漏性皮膚炎患者和約 140 萬異位性皮膚炎商業​​患者在這些適應症預期獲得批准後接受皮膚科醫生治療。

We could also add another 3 million patients across the same indications who have Medicare or Medicaid coverage and who are also treated by dermatologists. And then finally, we are actively working towards a strategic partnership that could allow us to expand into the roughly 6 million patients treated with print by primary care or pediatrics across those indications.

我們還可以增加另外 300 萬名具有相同適應症的患者，他們擁有 Medicare 或 Medicaid 承保範圍，並且也接受皮膚科醫生的治療。最後，我們正在積極努力建立策略合作夥伴關係，使我們能夠擴展到約 600 萬名透過初級保健或兒科接受列印治療的患者，涵蓋這些適應症。

We know there's been some questions about the pace of conversion from topical steroids to the newer non-steroidal, and we talked about this back in Q1 about other similar markets with established generic standard of care and how those conversions to newer class of drugs occurred over time.

我們知道，對於從局部類固醇轉換為新型非類固醇的速度存在一些疑問，我們在第一季度就已建立通用護理標準的其他類似市場討論了這一點，以及這些藥物向新型藥物的轉換是如何發生的時間。

And the topical dermatology market is right on track with these earlier prior examples, with roughly 5% conversion one year in. And we remain optimistic that the topical market will continue to convert and will eventually reach roughly 50% conversion.

外用皮膚科市場與這些早期的例子一樣，正步入正軌，一年後的轉換率約為 5%。我們仍然樂觀地認為外用市場將繼續轉變，並最終達到約 50% 的轉換率。

I'm also delighted to have Todd Edwards on board as our new Chief Commercial Officer and his leadership and proven credentials in the topical dermatology market will only further enhance our commercial execution. Under Todd's leadership, we have a robust plan to further accelerate the rate of growth and are investing in our commercial operations to drive that growth. With that, let me turn it over to Todd to provide some further commentary around the psoriasis launch.

我也很高興 Todd Edwards 擔任我們的新任首席商務官，他的領導能力和在局部皮膚病學市場上久經考驗的資歷只會進一步增強我們的商業執行力。在托德的領導下，我們制定了一項穩健的計劃，以進一步加快成長速度，並投資於我們的商業營運以推動成長。接下來，讓我將其轉交給托德，以提供有關牛皮癬發布的進一步評論。

Thanks, Frank. I'm very enthusiastic about joining our Peter's team and looking forward to the tremendous opportunity ahead. It's great to be speaking with all of you today to provide a brief commercial update.

謝謝，弗蘭克。我非常熱衷於加入我們 Peter 的團隊，並期待未來的巨大機會。很高興今天能與大家交談並提供簡短的商業更新。

Moving to slide 8, ZORYVE psoriasis launch continues to progress nicely, and we have specific plans to further accelerate the launch trajectory, laying a solid foundation for sustained growth in psoriasis and further growth in new indications as I come on board, I see healthy steady demand that is driven by the strength of the clinical profile.

轉到投影片8，ZORYVE 乾癬的上市繼續進展順利，我們有具體計劃進一步加快上市軌跡，為銀屑病的持續增長和新適應症的進一步增長奠定堅實的基礎，當我加入時，我看到健康穩定由臨床特徵的強度驅動的需求。

After spending the last several weeks in meetings with dermatologists NPs and PAs currently using ZORYVE, the feedback I received about the product is exceptional. The prescriber spoke to me about the patient's been delighted by the results achieved with ZORYVE, the NRx and TRx prescription volume is growing every quarter. And as I read has over 100,000 TRxs launch-to-date.

在過去幾週與目前使用 ZORYVE 的皮膚科醫生 NP 和 PA 進行會議後，我收到的有關該產品的反饋非常好。處方醫生告訴我，病人對 ZORYVE 所取得的效果感到很高興，NRx 和 TRx 處方量每季都在成長。據我所知，迄今為止已推出超過 100,000 個 TRx。

We are starting to see a preference for ZORYVE relative to nonsteroidal competitor and eight intends riders are increasing their utilization of facilities. The new pediatric label expansion down to six years of age incrementally expands our opportunities for growth and further strengthens our ease safety and tolerability profile.

我們開始看到相對於非類固醇競爭對手，人們更喜歡 ZORYVE，並且八名意向騎手正在增加他們對設施的利用率。新的兒科標籤擴展到六歲，逐步擴大了我們的成長機會，並進一步增強了我們的安全性和耐受性。

We expect demand growth as we capitalize on our investments in the launch and strengthen our field execution. One very large incremental opportunity to accelerate prescription growth is expansion into Medicaid and Medicare beginning in early 2024, roughly a third of psoriasis patients and nearly a half of Seb Derm topic dermatitis patients are on Medicare or Medicaid. ZORYVE is pricing falls below the Sienna, especially threshold, unlike other branded topicals. So, we are much better positioned to access these patient segments.

隨著我們利用我們在發布中的投資並加強我們的現場執行力，我們預計需求將會成長。加速處方成長的一個非常大的增量機會是從 2024 年初開始擴展到醫療補助和醫療補助，大約三分之一的牛皮癬患者和近一半的 Seb Derm 主題皮膚炎患者正在享受醫療補助或醫療補助。與其他品牌主題不同，ZORYVE 的定價低於 Sienna，尤其是門檻。因此，我們能夠更好地接觸這些患者群體。

I am now on slide 9, so we differentiated pricing and access strategy continues to resonate with payers with over 130 million commercial lives covered 90% without a prior authorization. It was great to see the Arcutis team have secured coverage with all three large PBMs in the US within 12 months of the launch.

我現在在投影片 9 上，因此我們的差異化定價和存取策略繼續引起付款人的共鳴，在未經事先授權的情況下覆蓋了 90% 的超過 1.3 億商業生活。很高興看到 Arcutis 團隊在發布後 12 個月內就涵蓋了美國所有三個大型 PBM。

And most recently, Express Scripts modified the criteria for ZORYVE coverage removing that double set of data for patients who have interchanges plaques and recognition as a reach unique indication for treating these patients. We anticipate further improvements in our commercial coverage as we go into 2024 as well as accelerated commercial coverage for the foam at launch with top two of the top three PBMs, expected to cover the product at approval as line extensions.

最近，Express Scripts 修改了 ZORYVE 覆蓋範圍的標準，刪除了具有互換斑塊的患者的兩組數據，並將其視為治療這些患者的獨特適應症。我們預計，進入 2024 年，我們的商業覆蓋範圍將進一步改善，並且在推出時，前三名 PBM 中的前兩名將加快泡沫的商業覆蓋範圍，預計將在批准作為產品線延伸時覆蓋該產品。

We will continue to build upon the improvements seen in gross to net for Q3 and Q4 and expect that progress to continue in subsequent quarters where that's approaching our target gross-to-net for the psoriasis indication by the second half of 2024. From my experience, I'm confident in the opportunity to improve gross to net with derm products.

我們將繼續在第三季和第四季的毛淨值改善的基礎上繼續努力，並預計在接下來的幾個季度中將繼續取得進展，到2024 年下半年接近我們的銀屑病指標毛淨值目標。根據我的經驗，我對透過皮膚產品提高​​毛淨值的機會充滿信心。

We are already seeing very encouraging trends. The percentage of prescriptions being covered by insurers with a clear opportunity to expand on its financing, a collaboration that contracted pharmacy partners to ensure willingness to improve coverage rates.

我們已經看到了非常令人鼓舞的趨勢。保險公司承保的處方藥百分比有明確的機會擴大其融資，這是與藥房合作夥伴簽約的合作，以確保提高承保率的意願。

I'm now on slide 10. The team has been focused on three pillars of commercial success for sustaining and service growth. Firstly, driving health care provider awareness and use that prescriber base is growing steadily with now about 9,000 unique prescribers since launch.

我現在正在看投影片 10。該團隊一直專注於商業成功的三大支柱，以維持和服務成長。首先，提高醫療保健提供者的認識和使用，自推出以來，處方者群體正在穩步增長，目前約有 9,000 名獨特的處方者。

And we just completed a 15% increase in field force size focused on high volume geographies that [field] team will drive a broad efficacy messaging to move physicians along the adoption curve. Our initial trial in specific regions of the body expanded use for patients who have psoriasis plaques across a larger body surface area.

我們剛剛完成了將現場人員規模增加 15%，並專注於高容量地區，[現場]團隊將推動廣泛的功效訊息傳遞，以推動醫生沿著採用曲線前進。我們在身體特定區域的初步試驗擴大了對較大體表面積有牛皮癬斑塊的患者的使用。

Secondly, patient engagement as refills continue to be an important driver of long-term growth. The number of refills in the third quarter increased by 50% versus the second quarter, which continues to be encouraging and in line with what we want and expect to see even the positive experience patients had a history.

其次，患者參與續藥仍是長期成長的重要驅動力。與第二季度相比，第三季的續藥數量增加了 50%，這仍然令人鼓舞，並且符合我們想要和期望看到的情況，甚至患者有過積極的體驗。

As mentioned, we also went live in September with a targeted DTC campaign to drive further branded requests. And finally, the broad high-quality access in both commercial and incremental Medicare and Medicaid coverage creates the opportunity for more patients to experience.

如前所述，我們也在 9 月推出了有針對性的 DTC 活動，以推動進一步的品牌需求。最後，商業和增量醫療保險和醫療補助覆蓋範圍的廣泛高品質訪問為更多患者創造了體驗機會。

We also looking forward to upcoming launches and new indications. And so I'll hand it over to Patrick to cover that.

我們也期待即將推出的產品和新的適應症。所以我會把它交給派崔克來解決這個問題。

Thank you, Todd. And I'm now on Slide 12. As Frank highlighted, it's been a very busy quarter, and I'm extremely proud of the team's performance and delivering on the promise of topical roflumilast to the dermatology community and hitting all of our timelines with regard to regulatory milestones.

謝謝你，托德。我現在在投影片12 上。正如Frank 所強調的，這是一個非常繁忙的季度，我對團隊的表現感到非常自豪，並兌現了對皮膚病學界外用羅氟司特的承諾，並滿足了我們所有的時間表達到監管里程碑。

So starting with psoriasis first, here, we announced the approval down the age of six. This expands our current indication and the overall opportunity in pediatrics. And we look forward to adding two- to five-year-olds in psoriasis, which will be the subject of a future FDA review pending some additional data.

因此，我們首先從牛皮癬開始，在這裡，我們宣佈在六歲以下就獲得批准。這擴大了我們目前的適應症和兒科的整體機會。我們期待將患有牛皮癬的兩到五歲兒童納入其中，這將是 FDA 未來審查的主題，等待一些額外的數據。

Moving on to Seb Derm, which should be the first indication for the foam, where we have an upcoming to do for on December 16, with it early 2024 launch being planned. Physician excitement for Seb Derm is palpable driven both by our unprecedented efficacy with this once-a-day moment and an area where there has been no innovation in decades and no branded competition, all this in a market as big as psoriasis.

接下來是 Seb Derm，這應該是該泡沫的第一個適應症，我們將於 12 月 16 日進行這項工作，並計劃於 2024 年初推出。醫生對Seb Derm 的興奮是顯而易見的，這既是因為我們在這個每天一次的時刻所具有的前所未有的功效，也是因為幾十年來沒有創新，也沒有品牌競爭的領域，所有這一切都發生在像牛皮癬這樣大的市場上。

Moving on to slide 13, where I want to highlight a few points on efficacy and Seb Derm on the left, I'm showing now 80% of patients got the IGA success. This means that they reached clear or almost clear on the IGA scale in eight weeks and they started from a baseline of moderate or severe.

轉到幻燈片 13，我想在其中強調關於功效和左側 Seb Derm 的幾點，我展示了現在 80% 的患者獲得了 IGA 成功。這意味著他們在八週內達到了 IGA 量表的明確或幾乎明確，並且他們從中度或嚴重的基線開始。

But what's really generated a lot of excitement is on the right where we show that we've got 50% of patients to completely clear. This means they had no erythema, no scaling, no evidence of disease not shown on this slide. But also, we saw improvement in itch in as little as 48 hours after initiating treatment is a primary symptom of Seb Derm and really drives an impact on quality of life.

但真正令人興奮的是右側，我們顯示我們有 50% 的患者需要完全清除。這意味著它們沒有紅斑，沒有鱗屑，沒有這張幻燈片上未顯示的疾病證據。而且，我們發現在開始治療後短短 48 小時內搔癢症狀有所改善，這是 Seb Derm 的主要症狀，確實對生活品質產生了影響。

And moving on to slide 14, now here, patient surveys highlight the significant negative impact that Seb Derm has on every day. Anxiety have a very negative impact on both social and work life with over three and four patients expressing anxiety about their disease. Over 90%, say it negatively impact their social lives.

轉到幻燈片 14，這裡的患者調查強調了 Seb Derm 對日常生活的重大負面影響。焦慮對社交和工作生活都有非常負面的影響，超過三到四名患者表達了對其疾病的焦慮。超過 90% 的人表示這對他們的社交生活產生了負面影響。

In addition, HCPs have expressed to me that they feel like they're failing their patients in many instances, these patients keep returning and docs don't have anything to offer beyond the same topical steroids and antifungals that they've been treating them with previously.

此外，醫護人員向我表示，他們覺得在很多情況下他們都讓患者失望了，這些患者不斷回來，除了他們一直在治療的相同外用類固醇和抗真菌藥物之外，醫生沒有什麼可以提供的之前。

We also recently reported quality of life data at the AMC. P-Com conference, which showed the meaningful benefit roflumilast foam had and improving patient quality of life as measured by the Dermatology Life Quality Index or DOQI.

我們最近也報告了 AMC 的生活品質數據。 P-Com 會議，展示了羅氟司特泡沫的有意義的益處，並改善了透過皮膚病生活品質指數（DOQI）衡量的患者生活品質。

Moving on to slide 15, I see some Seb Derm is having some dynamics that are favorable for rapid adoption. We have significant pent-up demand for this novel nonsteroidal foam offering, primarily due to lack of brand competition and lack of innovation, but also higher patient dissatisfaction and what we see in psoriasis and a greater need for better treatment options as many patients are on impractical treatment regimens, composed of topical corticosteroids and antifungals that have significant limitations of use.

轉到幻燈片 15，我看到一些 Seb Derm 正在發揮一些有利於快速採用的動力。我們對這種新型非類固醇泡棉產品有大量被壓抑的需求，這主要是由於缺乏品牌競爭和創新，而且患者的滿意度更高，以及我們在牛皮癬中看到的情況，以及由於許多患者正在接受治療，因此更需要更好的治療選擇不切實際的治療方案，由外用皮質類固醇和抗真菌藥物組成，其使用具有很大的局限性。

We also have an opportunity to leverage the positive experience in psoriasis with those already prescribing and deleverage foam to further expand this of prescriber base. As Todd mentioned, the benefits of accelerated commercial coverage for this film and approval will also help with HCP confidence in prescribing.

我們還有機會利用那些已經開處方的人在牛皮癬方面的積極經驗，並減少泡沫，以進一步擴大處方者基礎。正如托德所提到的，加速這部電影的商業報告和批准的好處也將有助於增強 HCP 對處方的信心。

Finally, moving on to atopic dermatitis. We made our submission of a supplemental NDA down to the age of six with an anticipated approval in early Q3 2024, and also released a positive key and taking that key readout for patients ages 2-5 in September.

最後，轉向異位性皮膚炎。我們提交了一份針對6 歲以下患者的補充NDA，預計將於2024 年第三季初獲得批准，並且還發布了積極密鑰，並於9 月份為2-5 歲的患者讀取了該密鑰。

On slide 16, we're highlighting our recent release of some very exciting long-term data in atopic dermatitis that demonstrated efficacy continues to improve with long term use, meaning four weeks in the pivotal trial and then an additional 52 weeks for a total of 56 weeks.

在投影片16 上，我們重點介紹了我們最近發布的一些非常令人興奮的異位性皮膚炎長期數據，這些數據表明，長期使用效果會持續改善，這意味著關鍵試驗需要4 週，然後再進行52 週，總共56 週。

Here, we're showing EASI-75, which is a very clinically relevant endpoint, where the proportion of responders grows from about 43% at week four, which is the end of the pivotal to roughly 66% of patients, achieving a 75 improvement at the end of treatment, which is 56 weeks.

在這裡，我們展示了 EASI-75，這是一個與臨床非常相關的終點，其中響應者的比例從第四週（關鍵終點）的約 43% 增長到大約 66% 的患者，實現了 75 的改善治療結束時，即56 週。

This is really exciting because you see an increased benefit over time and disease under better control. But what makes these data even more impactful is that we achieve disease control was a less frequent and maintenance regimen where patients were switched to twice weekly treatment if they were completely clear, very happy with this response, it fits nicely with clinical practice and it's been very well received by dermatologists.

這確實令人興奮，因為隨著時間的推移，您會看到益處不斷增加，並且疾病得到了更好的控制。但使這些數據更具影響力的是，我們實現疾病控制是一種不太頻繁的維持方案，如果患者完全清楚，對這種反應非常滿意，則轉為每週兩次治療，它非常適合臨床實踐，並且已經得到了證實。深受皮膚科醫生的好評。

I'm very excited about roflumilast cream clinical profile and the significant opportunity in this large growing market. The dynamics here are favorable also for the rapid adoption showing some of the same positive tailwinds as Seb Derm, in particular, in pediatric patients, there's a propensity to adopt nonsteroidals, which is higher than in psoriasis, but this is driven largely by the desire of patients to avoid topical steroids. With that, I'll hand it over to John.

我對羅氟司特乳膏的臨床概況以及這個不斷增長的龐大市場中的重大機會感到非常興奮。這裡的動態也有利於快速採用，顯示出一些與Seb Derm 相同的積極推動力，特別是在兒科患者中，有採用非類固醇的傾向，這種傾向高於銀屑病患者，但這主要是由願望驅動的患者避免使用局部類固醇。這樣，我就把它交給約翰了。

Thank you, Patrick. Good morning, everybody. I'm beginning on slide 18, for the third quarter, we reported net product revenue of $8.1 million, reflecting a 70% growth quarter-over-quarter on top of the about 70% growth in Q2. This was largely driven by substantial gross to net percentage improvements down to the lower 70s, particularly with the CVS coverage win and the team's execution to ensure for prescriptions are covered by insurers.

謝謝你，派崔克。大家早安。我從投影片 18 開始，第三季我們報告的淨產品收入為 810 萬美元，反映出在第二季約 70% 的成長基礎上環比成長 70%。這主要是由於毛淨百分比大幅提高至 70 左右，特別是 CVS 承保範圍的勝利以及團隊確保保險公司承保處方藥的執行力。

We also saw healthy demand growth in the quarter. Looking forward to Q4, we expect further or even demand growth and gross to net improvement versus Q3.

本季我們也看到需求的健康成長。展望第四季度，我們預計需求將進一步甚至成長，毛淨比將比第三季度有所改善。

On Slide 19, I'll walk you through the rest of the P&L. We reported total revenues of $38 million for the quarter, which included in other revenues, the upfront payment, a payment we received from [WHO data], collaboration and license agreement.

在投影片 19 上，我將向您介紹損益表的其餘部分。我們報告的本季總收入為 3800 萬美元，其中包括其他收入、預付​​款、我們從[世界衛生組織數據]收到的付款、合作和授權協議。

R&D expenses of $26.2 million were down significantly from Q3 2022, due to the upfront milestone payment for the Ducentis acquisition, as well as continued decrease of development costs of topical roflumilast programs.

由於 Ducentis 收購的前期里程碑付款以及局部羅氟司特專案開發成本的持續下降，研發費用為 2,620 萬美元，較 2022 年第三季大幅下降。

We expect Q4 R&D to be on par with Q3 and expect fiscal year 2024 R&D expense to decline versus fiscal year 2023. SG&A is a result of higher commercialization expense year-over-year, which reflects our continued investment in our ZORYVE launch and upcoming launches and Seb Derm in atopic dermatitis. As Todd mentioned, additional sales force will drive modest incremental SG&A growth in Q4 versus Q3. Lastly, net loss per share of $0.73 improved by over $1.15 per share year over year.

我們預計第四季度的研發將與第三季持平，並預計2024 財年的研發費用將比2023 財年有所下降。SG&A 是商業化費用同比增加的結果，這反映了我們對ZORYVE 的推出和即將推出的產品的持續投資和 Seb Derm 治療異位性皮膚炎。正如托德所提到的，與第三季相比，額外的銷售人員將推動第四季的銷售及管理費用（SG&A）適度增量成長。最後，每股淨虧損 0.73 美元，年減 1.15 美元以上。

Moving on to slide 20, on the balance sheet, cash, and marketable securities of $228 million as of the end of the quarter, which obviously does not include the recent raise of $100 million that we completed in early October. That raise provides a path to expand our psoriasis launch as well as capitalize on the significant expansion and market opportunity for topical roflumilast into Seb Derm and AD.

轉到投影片 20，截至本季末，資產負債表、現金和有價證券為 2.28 億美元，這顯然不包括我們在 10 月初完成的近期融資 1 億美元。此次融資為擴大我們的銀屑病產品上市以及利用外用羅氟司特進入 Seb Derm 和 AD 的重大擴張和市場機會提供了一條途徑。

We also recently undertook a reorganization to resize all not commercial efforts to align with R&D prioritization. You can expect us to continue to refine and sharpen our efforts around cash burn as we make continued progress on expanding or even all indications. The net proceeds of the capital raised recently in October, plus our existing cash plus what we believe to be our forecasted revenue provides runway into 2025. We also remain confident in progressing them an out-license deal in Japan potentially by the end of 2013 to bring in additional non-dilutive capital, which would further extend our runway.

我們最近也進行了重組，調整所有非商業工作的規模，以與研發優先順序保持一致。隨著我們在擴大甚至所有適應症方面不斷取得進展，您可以期待我們繼續完善和加強圍繞現金消耗的努力。最近 10 月籌集的資金淨收益，加上我們現有的現金以及我們認為的預測收入，為 2025 年提供了跑道。我們仍然有信心在 2013 年底前與他們在日本達成一項向外許可協議引入額外的非稀釋性資本，這將進一步延長我們的跑道。

I also want to provide some important updates on our amended loan terms, which we recently agreed to with our lender SLR. As many of you are aware, on the existing $200 million we have on the balance sheet that we've drawn down. There were two, in particular financial covenants in place of market cap covenant and a revenue covenant.

我還想提供有關我們最近與貸方 SLR 達成協議的修訂貸款條款的一些重要更新。正如你們許多人所知，我們已經提取了資產負債表上現有的 2 億美元資金。有兩個契約，特別是代替市值契約的財務契約和所得契約。

I'm glad to report that the market cap, the market cap covenant has been removed and has been replaced with a capital covenant where the company has to obtain $31 million by the end of Q1 2024, which could largely come from an upfront payment that I just mentioned around the Japanese out-license.

我很高興地報告，市值、市值契約已被取消，並已被資本契約所取代，其中該公司必須在 2024 年第一季末之前獲得 3100 萬美元，這主要來自於預付款我剛剛提到了日本的外許可。

The revenue covenant has been modified requiring us to achieve at least 75% of our agreed-upon product revenue forecast, which replaces the previous minimum net product revenue table. For year-end 2023, this has an effect of reducing the 30 million trailing revenue requirements to below 25 million.

收入契約已修改，要求我們至少實現商定的產品收入預測的 75%，這取代了先前最低的淨產品收入表。到 2023 年底，這將 3,000 萬的追蹤收入要求減少到 2,500 萬以下。

Finally, the final loan tranche of 25 million has been eliminated. We appreciate SLRs continued partnership and are delighted with these changes and feel they provide the company's significant operating flexibility going forward. With that, I will hand back to Frank to speak and for some closing comments, and then we will open for Q&A session.

最終，最後一筆2500萬的貸款已經被取消。我們讚賞 SLR 持續的合作夥伴關係，並對這些變化感到高興，並認為它們為公司未來的營運提供了顯著的靈活性。接下來，我將交回弗蘭克發言並發表一些結束語，然後我們將開始問答環節。

Thanks John. As John mentioned, we continue to evaluate all of our activities as we transition from a development stage to a commercial stage company in order to effectively manage our expenses. Back in Q1, we announced a deprioritization of a number of our R&D programs and then based on those changes and as our ongoing large Phase 3 trials are winding down.

謝謝約翰。正如約翰所提到的，當我們從開發階段過渡到商業階段的公司時，我們將繼續評估我們的所有活動，以便有效地管理我們的費用。早在第一季度，我們就宣布取消一些研發計劃的優先級，然後根據這些變化以及我們正在進行的大型第三階段試驗逐漸結束。

Earlier this quarter, we completed a limited restructuring to better align our organization with our ongoing activities. Today with the expected approval of roflumilast foam and the successful submission of the AD. [NDA]. We're announcing some further changes in our leadership to further align our organization with our priorities

本季度早些時候，我們完成了有限的重組，以更好地使我們的組織與我們正在進行的活動保持一致。今天，羅氟司特泡沫如期獲得批准，並成功提交了 AD。 [保密協議]。我們宣布對領導層進行一些進一步調整，以進一步使我們的組織與我們的優先事項保持一致

Patricia turning will be stepping down as our Senior Vice President of Operations, and David Osborne will be retiring as our Chief Technical Officer. Both Patricia and David will continue on as consultants to the company to facilitate this organizational transition and to lend their extensive expertise in the future.

帕特里夏·特恩 (Patricia Turning) 將辭去我們的高級營運副總裁職務，大衛·奧斯本 (David Osborne) 將辭去我們的首席技術官職務。派翠西亞和大衛都將繼續擔任公司顧問，以促進這項組織轉型，並在未來提供他們廣泛的專業知識。

We will be merging our technical operations and product development organizations and Bethany Dudek is being promoted to the role of Chief Technical Officer overseeing the range of these activities. We're excited to have Stephanie taking over our technical operations. She has been with our tutors for the past three years, as the head of quality and has done an outstanding job, I would add I've worked with Bethany off and on for the past 15 years, she's an outstanding executive, and I feel very confident about it.

我們將合併我們的技術營運和產品開發組織，Bethany Dudek 將晉升為首席技術官，負責監督這些活動的範圍。我們很高興史蒂芬妮接管我們的技術營運。她在過去的三年裡一直和我們的導師一起工作，擔任品質主管，工作非常出色，我想補充一點，在過去的15 年裡，我斷斷續續地與Bethany 一起工作，她是一位出色的高管，我覺得對此非常有信心。

She brings to her new position, extensive experience across product development, quality and manufacturing build over a 28 year career at Arcutis, Kite, Novartis and Amgen. So, with the ongoing ZORYVE launch and all of the additional opportunities ahead of us, I believe we are incredibly well positioned to execute on our mission of building the preeminent immunodermatology company and continuing to build shareholder value. And with that, we'll open it up for Q&A.

她將在 Arcutis、Kite、Novartis 和 Amgen 28 年職業生涯中積累的產品開發、品質和製造方面的豐富經驗帶到了新職位。因此，隨著 ZORYVE 的不斷推出以及我們面前的所有額外機會，我相信我們處於非常有利的位置，能夠履行我們的使命，即建立卓越的免疫皮膚病學公司並繼續創造股東價值。接下來，我們將開放它進行問答。

Thank you. (Operator Instructions)

謝謝。 （操作員說明）

Tyler Van Buren, TD Cowen.

泰勒·範布倫，TD·考恩。

Hey, guys. Good morning and congratulations on all the progress during the quarter. I have a couple for you related to Seb Derm. So for the potential topical fumas approval for Seb Derm, can you elaborate on where you are with the regulatory review and if you've started labeling discussions?

大家好。早上好，恭喜本季取得的所有進展。我為您準備了一些與 Seb Derm 相關的產品。那麼，對於 Seb Derm 潛在的外用 fumas 批准，您能否詳細說明一下您在監管審查方面的進展情況以及您是否已經開始標籤討論？

And then the second question, just regarding the launch trajectory and the coverage relative to ZORYVE, I think you mentioned that, two of the three major PBMs expect to approve it as a line extension. So, does that happen immediately upon approval? Or what's the timeframe and logistics? And then also, how long do you think it will take to get the third PBM online?

然後是第二個問題，關於 ZORYVE 的發射軌跡和覆蓋範圍，我想您提到過，三個主要 PBM 中的兩個希望批准它作為產品線延伸。那麼，批准後會立即發生嗎？或是時間安排和物流是怎麼樣的？另外，您認為第三個 PBM 上線需要多長時間？

Yes, that's great. That's great to hear from you. With regard to the Seb Derm as a policy, we don't comment on ongoing reviews with the FDA. So, I don't feel it would be appropriate for me to make any comments on the process. I will say that I think we feel very confident about the upcoming [Purdue for] date, and we think that the data speaks for itself.

是的，那太好了。很高興收到你的來信。關於 Seb Derm 作為一項政策，我們不對 FDA 正在進行的審查發表評論。因此，我認為我不適合對該過程發表任何評論。我想說的是，我認為我們對即將到來的[普渡大學]日期非常有信心，我們認為數據不言自明。

With regard to the coverage, I think I'd ask Todd to respond to that one, if you could both to clarify on the first two and then timing on the third --

關於報道，我想我會請托德對此做出回應，如果你們能澄清前兩個問題，然後澄清第三個問題的時間——

Yeah, absolutely correct. Thank you and good question. Relative to the two contracts in September with two of the as mentioned, with two of the large PBMs within our contracts today, the Seb Derm launch will be treated as a line extension.

是的，絕對正確。謝謝你，好問題。相對於 9 月的兩份合約（其中提到的兩份），以及我們今天合約中的兩份大型 PBM，Seb Derm 的推出將被視為產品線的延伸。

So, what that translates to is that we're starting to launch at a position of strength, meaning that at launch those two PBMs will cover Seb Derm as a covered product, which will help us also within a strong good start to our gross to net. The third PBM, we are currently in negotiations with, and those negotiations are very positive right now. So, we look to the further those conversations with the ambition of having coverage at launch with that third PBM.

因此，這意味著我們開始以強勢地位推出產品，這意味著在推出時，這兩個 PBM 將涵蓋 Seb Derm 作為涵蓋產品，這也將幫助我們為我們的總收入提供一個良好的開端。網。我們目前正在與第三個 PBM 進行談判，這些談判目前非常積極。因此，我們希望進一步開展這些對話，並希望在發佈時涵蓋第三個 PBM。

Thanks, Abigail, we can go to the next session.

謝謝阿比蓋爾，我們可以參加下一場會議了。

Thank you.

謝謝。

Seamus Fernandez, Guggenheim Securities.

謝默斯·費爾南德斯，古根漢證券公司。

Great. Thanks for the questions. So, maybe just as a first discussion point, would you guys mind sort of comparing and contrasting the launch of ZORYVE and where you are in the launch relative to the impact of the sort of [Vitiligo] launch, for the brands that you used to work with.

偉大的。感謝您的提問。因此，也許作為第一個討論點，你們是否介意比較和對比 ZORYVE 的發布以及你們在發布中相對於[白斑]發布的影響的情況，對於你們曾經使用過的品牌與. 一起工作。

I think it's sort of an important and interesting comparison relative to the coverage dynamics as well as the opportunity for warehousing and sort of accelerated growth. So, just trying to get a relative sense of where you feel awareness is as a comparison, what this could mean for the overall brand, because unique indications really do seem to accelerate brands overall.

我認為，相對於覆蓋動態以及倉儲和加速成長的機會，這是一個重要且有趣的比較。因此，只是想透過比較來相對了解您的認知度，這對整個品牌意味著什麼，因為獨特的跡象確實似乎確實加速了品牌的整體發展。

And then just maybe, if you can provide us a little bit of color on how you see this sort of extension of coverage impacting gross-to-net. Should we be thinking about overall gross-to-net having a step down or even a slight movement down in the fourth quarter to kind of accommodate in that case.

然後也許，如果您能為我們提供一些關於您如何看待這種覆蓋範圍擴大對毛淨額影響的資訊。我們是否應該考慮在第四季度整體毛淨值下降甚至小幅下降以適應這種情況。

And then just a question for John. What does state in terms of the covenants, the 75% of can you just clarify, the 75% of revenue target, is that just for this year? Or is it the sort of sequential targets that are laid out. So, 75%, all of the targets that are laid out, in that sort of revenue of planning phase? Thanks.

然後問約翰一個問題。契約方面的規定是什麼？您能否澄清一下，75% 的收入目標，只是今年的嗎？或者它是那種被安排的連續目標。那麼，75% 是在規劃階段的收入中所訂定的所有目標？謝謝。

So, Seamus is always good to hear from you. So, just so we're clear you're asking, Todd about ZORYVE and sort of the dynamics between psoriasis and Seb Derm and how that compares to [Abslura] and the dynamics with atopic dermatitis and vitiligo.

因此，Seamus 很高興收到您的來信。所以，我們很清楚，Todd，您在問 ZORYVE 以及牛皮癬和 Seb Derm 之間的動態，以及與 [Abslura] 相比如何，以及與異位性皮膚炎和白斑的動態。

Yes, I just didn't name the product.

是的，我只是沒有命名該產品。

Yeah, yeah, that's okay. I can say that. Go head, Todd.

是啊是啊，沒關係。我可以這麼說。走吧，托德。

Yes, great. No, thank you. So, first thing relative to ZORYVE launch. So, I'm So currently, we're working on some disease state awareness activity for both patients and dermatologists. That's a targeted education, which will likely be focused, obviously, prelaunch with the emphasis on the frustration of the condition, the impact on quality of life as well as the [poly pharmacy] that occurs here.

對，很好。不，謝謝。那麼，第一件事就是 ZORYVE 的推出。所以，目前我們正在為患者和皮膚科醫生進行一些疾病狀態意識活動。這是一種有針對性的教育，顯然，它可能會在啟動前重點關注病情的挫折、對生活品質的影響以及這裡發生的[多藥房]。

We're talking about five to six treatments per patient and often it takes 15 to 30 minutes a day spent with this regiment. So, it's a very frustrating situation for patients. There's been no innovation branded products within this space for over two decades. And if you think about the number of available patients that you talked about a warehouse of patients.

我們討論的是每位患者接受 5 到 6 次治療，通常每天需要 15 到 30 分鐘進行此治療。因此，這對患者來說是一個非常令人沮喪的情況。二十多年來，這個領域一直沒有創新品牌產品。如果您考慮一下可用患者的數量，您就談到了患者倉庫。

So, there is a ready full of patients that are yearning for a product like ZORYVE that provides a very unique value proposition because this product you can use once-a-day product that you can use this one product versus poly pharmacy and delivers long-term disease control. As you think about it, there's about 10 million patients that are diagnosed with ZORYVE dermatitis.

因此，有很多患者都渴望像ZORYVE 這樣的產品，它提供了非常獨特的價值主張，因為這種產品您可以使用一天一次的產品，與多藥房相比，您可以使用這種產品，並提供長期-術語疾病控制。想想看，大約有 1000 萬患者被診斷出患有 ZORYVE 皮膚炎。

Of that, about 7 million of them are treated with TRx. If you continue to break it down, about 4 million are treated with [TRx derm] setting. And of that 3.2 million are treated with the TCS. And if you drop it into our treatment zone, 2.2 million of those are moderate to severe patients they're currently taken at TCS. So, there's significant opportunity here to really bring the story to life. Furthermore, we're starting from a position of strength with this formulary position as mentioned, were two to three. PBMs will cover as a line extension at launch.

其中，約 700 萬人接受了 TRx 治療。如果繼續細分，大約有 400 萬人接受了 [TRx derm] 設定治療。其中 320 萬人接受 TCS 治療。如果你將其放入我們的治療區，其中 220 萬名中度至重度患者目前正在 TCS 接受治療。因此，這裡有一個重要的機會來真正將這個故事變成現實。此外，我們從一個有實力的位置開始，如上所述，這個公式位置是二到三個。 PBM 在發佈時將作為產品線延伸。

And you asked a question about gross-to-net. So, we expect that on with the ZORYVE launch. We're not starting from ground zero, launching a new asset into the market to where you have to provide a free goods program is going to have an adverse impact on your gross to net will have coverage with the two PBMs, those will be reimbursed claims at a positive gross to net.

你問了一個關於總淨值的問題。因此，我們預計 ZORYVE 的推出也會實現這一點。我們不是從零開始，向市場推出一項新資產，您必須提供免費商品計劃，這將對您的毛淨額產生不利影響，這將受到兩個 PBM 的覆蓋，這些將得到報銷索賠總額與淨額為正。

So, the gross-to-net will Seb Derm at launch will be higher relative to the gross to net that we have in psoriasis. But nonetheless, we believe that gap will rapidly close over time in 2024, as we bring on that third PBM coverage and maximized our covered claims.

因此，Seb Derm 在推出時的淨毛比將高於我們在牛皮癬領域的毛淨比。但儘管如此，我們相信隨著時間的推移，這一差距將在 2024 年迅速縮小，因為我們將推出第三次 PBM 承保範圍並最大限度地擴大我們的承保索賠範圍。

it�s done?

完成了嗎？

Yes.

是的。

Hi, Seamus, this is John to answer your question on the covenants. The 75% applies to the year-end number for 2023, year plan number. And then it's a monthly calculation in 2024, with a six-month lagging average. So, whatever that number is you fly 75% if we're above, were good. And that's measured each month in 2024.

你好，西莫，我是約翰，我要回答你關於聖約的問題。 75%適用於2023年年末數、年度計畫數。然後是2024年的月度計算，滯後六個月的平均值。所以，無論這個數字是多少，如果我們高於 75%，那就很好了。這是 2024 年每個月的測量。

Great, thank you. And maybe just as well, just a quick final follow-up in terms of the stocking necessary to really have this be executed as a robust launch, when should we anticipate the sort of official launch of the foam, regardless of the sort of producer approval time lines, is this a, day of kind of [Pedufa] hitting the ground running?

太好了謝謝。也許還好，只是在庫存方面進行快速的最後跟進，以真正將其作為一次強有力的發布來執行，我們應該何時預期泡沫的正式發布，無論生產商的批准如何時間線，這是[ Pedufa] 立即行動的一天嗎？

Or should we think about this as more of a potential sort of stocking the pharmacies event in the last few weeks of the year, followed by maybe a mid-January to kind of February launch time frame. Just trying to get a little bit of incremental granularity before we get too excited to track the Seb Derm scripts? Thanks.

或者我們是否應該將其視為今年最後幾週的潛在的藥房備貨活動，然後可能是一月中旬到二月的發佈時間框架。只是想在我們太興奮而無法跟踪 Seb Derm 腳本之前獲得一點增量粒度嗎？謝謝。

Yes, absolutely. So, as mentioned, yeah, the Pedufa December 16, with a full commercial launch anticipated to be mid to late January. So, we want to make certain we have ample time to be able to stock the channel, make certain pharmacies have product on shelf as we launch this and drive demand.

是的，一點沒錯。所以，如前面提到的，是的，Pedufa 將於 12 月 16 日發布，預計將於 1 月中下旬全面商業發布。因此，我們希望確保我們有足夠的時間能夠為通路備貨，讓某些藥局在我們推出此產品並推動需求時有貨架上的產品。

And maybe just to put a fine point on that kind of a,, Seamus, as with topicals, it's a little challenging because of labeling and more challenging than pills or biologic. So, I don't think you should anticipate to see any stocking in Q4.

也許只是為了強調一點，Seamus，就像外用藥物一樣，由於標籤的原因，它有點具有挑戰性，而且比藥丸或生物製劑更具挑戰性。因此，我認為您不應該期望在第四季度看到任何庫存。

Perfect. Thanks so much. (multiple speakers)

完美的。非常感謝。 （多個發言者）

Vikram Purohit, Morgan Stanley.

維克拉姆‧普羅希特，摩根士丹利。

Hi, good morning. Thanks for taking our questions. We had two, first on the ZORYVE psoriasis specifically, could you just unpack for us in a bit more detail? What drove the quarter to quarter gross-to-net change we saw from 2Q to 3Q and then and specifically what needs to happen from here on out to compress gross-to-net from where it is now to kind of steady state.

早安.感謝您回答我們的問題。我們有兩個，第一個是 ZORYVE 牛皮癬，您能為我們詳細介紹一下嗎？我們從第二季到第三季看到了是什麼推動了季度毛淨值變化，然後具體是從現在開始需要發生什麼才能將毛淨值從現在的水平壓縮到某種穩定狀態。

And I think you mentioned second half of next year? And then secondly, on seborrheic dermatitis , apologies if you mentioned this in our response to a previous question and I missed it, but how do you think the actual uptake and script trajectory excuse me, for Seb Dermfor the initial couple of quarters could compare to what we saw with ZORYVE psoriasis post. So, the launch of that product? Thanks

我想你提到了明年下半年？其次，關於脂漏性皮膚炎，如果您在我們對上一個問題的回答中提到這一點而我錯過了，我深表歉意，但是您認為實際的吸收和腳本軌跡如何，對不起，對於Seb Derm 來說，最初的幾個季度可以與我們在 ZORYVE 牛皮癬貼上看到的情況。那麼，該產品的推出呢？謝謝

Yeah. So, I think this probably are both for Todd.

是的。所以，我認為這可能都是托德的。

Yeah, absolutely. So let me first cover off on relative to the gross-to-net and what drove the change in gross-to-net, what we need to continue to do to add to amplify improvement. So, the improvement in coverage, as we saw in Q2, obviously accelerating Q3. So, on, we saw an improvement in the percentage of covered prescriptions across all the major PBMs in Q3 with CVS driving the most dramatic improvements.

是的，絕對是。因此，讓我先介紹一下毛淨值的相關情況，以及推動毛淨值變化的因素，以及我們需要持續採取哪些措施來擴大改善。因此，正如我們在第二季度看到的那樣，覆蓋範圍的改善明顯加速了第三季的發展。因此，我們看到第三季所有主要 PBM 承保處方的百分比有所改善，其中 CVS 推動的改善最為顯著。

Also seen improvement across the other two large PBMs. You think about it, this translates into reduced co-pay expenses and provides us a springboard to continue to improve gross-to-net and leverage this progress further. We expect our field force execution and to be a continued focus on points through our coverage to produce improved gross-to-net in Q4 and beyond.

其他兩個大型 PBM 也有所改善。你想一想，這意味著共同支付費用的減少，並為我們提供了一個跳板，以繼續提高毛淨值並進一步利用這一進展。我們期望我們的現場人員執行力，並透過我們的覆蓋範圍繼續關注點，以在第四季度及以後提高毛淨值。

And as we roll forward, we're going to be building and working at developing partnerships with the dermatology pharmacies, which reinforces our conviction that we can achieve our target gross-to-net. So through food coverage through our partnerships with these independent derm pharmacies will translate into further improvements as we go forward with our gross-to-net.

隨著我們的前進，我們將建立並努力發展與皮膚科藥房的合作夥伴關係，這增強了我們的信念，即我們能夠實現毛淨比目標。因此，隨著我們繼續推進毛淨比，我們與這些獨立皮膚藥房的合作夥伴關係所提供的食品覆蓋範圍將轉化為進一步的改善。

And then the other question was --

然後另一個問題是——

Seb Derm uptake relative to psoriasis.

Seb Derm 吸收與牛皮癬有關。

Yeah, Seb Derm uptake relative to psoriasis, as I mentioned, there's a ready pool of patients that are dirty for new treatment options with Seb Derm There's no branded competition within the market. No innovation in the market for over two decades. And so, I would anticipate a robust uptake at launch with Seb Dermwhereas compared to the psoriasis market. It's a highly competitive market multiple competing products within there, which Seb Derm is very much unlike that.

是的，Seb Derm 相對於牛皮癬的吸收，正如我所提到的，有很多患者對 Seb Derm 的新治療方案不感興趣。市場上沒有品牌競爭。二十多年來市場上沒有任何創新。因此，與牛皮癬市場相比，我預計 Seb Derm 在推出時會受到強勁的歡迎。這是一個競爭激烈的市場，其中有多種競爭產品，而 Seb Derm 與此截然不同。

And Vikram, I just remind you to Todd's point, we picked up at CVS coverage [seven one] so right at the beginning, Q3. So, that was certainly major contributor, but not the only contributor to the improvements in gross-to-net.

Vikram，我只是提醒您托德的觀點，我們在第三季一開始就在 CVS 報導中了解到了 [七一]。因此，這肯定是主要貢獻者，但不是毛淨值改善的唯一貢獻者。

Understood. Thank you.

明白了。謝謝。

Our next question comes from Uy Ear with Mizuho.

我們的下一個問題來自 Uy Ear 和 Mizuho。

Hey guys, congrats on the good quarter and all the progress. I guess my question is for Todd, you've been there for a little while now? And just wondering, what are some of the changes that are different that you're looking into executing?

嘿夥計們，祝賀這個季度的良好表現和所有的進步。我想我的問題是問托德的，你已經在那裡待了一段時間了？只是想知道，您正在考慮執行哪些不同的變更？

I know that you've already added some sales force increased the sales force size, but what are some other changes that you might put in play to improve scrip uptakes for psoriasis and maybe, you know, as well as on for the Seb Derm upcoming launch? Thanks.

我知道您已經增加了一些銷售人員，增加了銷售人員規模，但是您可能會採取哪些其他改變來提高牛皮癬的代用券吸收率，也許，您知道，以及即將推出的 Seb Derm發射？謝謝。

Yeah, absolutely. And you have just done a few things on, after many years in dermatology, I see a tremendous opportunity to change the treatment paradigm in these three largest disease areas that we've been talking about here today to include psoriasis, eventually, Seb Derm and atopic dermatitis. If you think about it, the dermatology communities, they have been yearning for nonsteroidal options that still fit with their (inaudible),

是的，絕對是。您剛剛做了一些事情，經過多年的皮膚病學研究，我看到了改變我們今天在這裡討論的這三個最大疾病領域的治療模式的巨大機會，最終包括銀屑病，Seb Derm 和特應性皮膚炎。如果你想一想，皮膚病學界，他們一直渴望仍然適合他們（聽不清楚）的非類固醇選擇，

I'll call their topical first mentality terms are oriented towards the local treatment. You think about the ZORYVE data package, especially the long-term data appear. So, for Seb Derm or AD, and it's exceptional in my view, and it really hits the outcomes of dermatologists and patients are looking for. So, I see a ready opportunity, advancing the competitive share a voice or messaging, which of course, are no levers that can drive utilization within the dermatology community.

我將他們的主題第一心態稱為局部治療。你想想ZORYVE資料包，特別是長期資料的出現。因此，對於 Seb Derm 或 AD，在我看來這是特殊的，它確實達到了皮膚科醫生和患者所尋求的結果。因此，我看到了一個現成的機會，可以推動語音或訊息傳遞的競爭共享，當然，這並不是可以推動皮膚病學社群內利用的槓桿。

In addition to that, if you look at the perceptions of efficacy, they're very encouraging and differentiating attributes as a reef or resonating with prescribers. And as mentioned that the long-term data, I think is extremely meaningful and really differentiates that long-term value of ZORYVE, but dermatologists that well and grain are creatures of habit and it takes time to get them to critical mass of patients that have firms or is placed within the treatment paradigm and by creating depth within our current prescriber base, moving them along the adoption curve and moving up the average number of ZORYVE patients per prescriber will continue to accelerate the uptake in ZORYVE.

除此之外，如果你看看對功效的看法，它們作為珊瑚礁或與處方者產生共鳴的屬性是非常令人鼓舞和差異化的。正如前面提到的，我認為長期數據非常有意義，並且真正區分了 ZORYVE 的長期價值，但皮膚科醫生認為，良好和穀物是習慣的產物，需要時間才能讓他們接觸到臨界數量的患者公司或被置於治療範式中，並透過在我們目前的處方者基礎中建立深度，沿著採用曲線移動他們並提高每個處方者的ZORYVE 患者的平均數量，將繼續加速ZORYVE 的採用。

And as mentioned, we've hired the representatives to amplify our share a voice in September, we launched a targeted direct-to-consumer campaign, which we will continue to move forward, and we're going to have an expansion on the efficacy message to dermatologists to include a broader target patient with a higher BSA.

正如前面提到的，我們在 9 月聘請了代表來擴大我們的分享聲音，我們發起了一項有針對性的直接面向消費者的活動，我們將繼續推進該活動，並且我們將擴大功效向皮膚科醫生傳達的訊息是，要納入具有更高BSA 的更廣泛的目標患者。

And then I think, as mentioned earlier, there's an exceptional opportunity for expansion within Medicare, Medicaid. And that's also to mention that the expanded pediatric indication down to the age of six will provide us with our expansion opportunity in psoriasis.

然後我認為，正如前面提到的，醫療保險、醫療補助領域存在著絕佳的擴張機會。另外值得一提的是，將兒科適應症擴大到六歲將為我們提供擴大牛皮癬治療範圍的機會。

And maybe I'll just add because Todd is modest. We ran a very extensive search for our new Chief Commercial Officer. And it was very clear to me that time was the right person to join this team. I believe that leadership matters and we chose Todd, because look, he has a proven track record, he's done this before, he successfully launched other topical products in this space very recently has very effectively driven demand and has also very effectively managed gross-to-nets.

也許我會補充一點，因為托德很謙虛。我們對新任首席商務官進行了非常廣泛的搜尋。我很清楚，現在是加入這個團隊的合適人選。我相信領導力很重要，我們選擇了托德，因為看，他有良好的業績記錄，他以前做過這件事，他最近在這個領域成功推出了其他主題產品，非常有效地推動了需求，並且還非常有效地管理了總銷售額-網。

And I have complete confidence in him and his ability to lead our commercial team. We also did announce the promotion of Aisha Jeter to add both marketing and market access. You had been previously was she was the interim chief commercial officer and had been running market access. And I think along with Todd, I have real confidence in their ability to launch these additional indications and continue to drive the growth is there even psoriasis?

我對他和他領導我們商業團隊的能力充滿信心。我們還宣布了對 Aisha Jeter 的晉升，以增加行銷和市場准入。你之前是因為她是臨時首席商務官並且一直在管理市場准入。我認為與托德一起，我對他們推出這些額外適應症並繼續推動增長的能力充滿信心，甚至還有牛皮癬嗎？

Can I follow up with just a question on gross-to-net. So, I guess your view of your target is to reach steady state somewhere sometime in the second half of next year. It sort of implies that the quarterly pace improvement is pretty significant. I was just wondering if you can sort of just talk a bit and perhaps help us quantify, what the improvement could be in the fourth quarter, at least? Thanks.

我可以繼續問一個關於總淨值的問題嗎？所以，我猜你對目標的看法是在明年下半年的某個時候達到穩定狀態。這在某種程度上意味著季度速度的改善相當顯著。我只是想知道您是否可以稍微談談，也許可以幫助我們量化，至少在第四季度可以有哪些改進？謝謝。

I think (laugh) we intend not to give forward guidance on gross sense, I would say we saw a very significant improvement in Q3 over Q2. We saw a nice improvement Q2 or Q1, I think we will see further improvement in Q4 versus Q3. I will commit that it will be of a similar magnitude as what we saw in Q3 because that was it was a pretty big move.

我認為（笑）我們不打算就整體意義提供前瞻性指導，我想說我們看到第三季比第二季有了非常顯著的改善。我們看到第二季或第一季有了很大的改進，我認為我們將看到第四季相對於第三季的進一步改進。我承諾，這將與我們在第三季看到的情況類似，因為這是一個相當大的舉措。

But I think Q4, you may see a little bit of noise in Q1 with the co-pay resets, but we'll continue to make progress there in Q2 next year as well. I think it's not a miracle occurs here sort of phenomenon for us to get to our target gross to net with continued execution against the programs we already have in place and the coverage we have in place.

但我認為第四季度，隨著自付額重置，您可能會在第一季看到一些噪音，但我們也將在明年第二季度繼續取得進展。我認為，透過繼續執行我們已經制定的計劃和我們已有的覆蓋範圍，我們能夠達到我們的目標總收入，這並不是什麼奇蹟。

Okay, thank you.

好的謝謝。

Chris Shibutani, Goldman Sachs.

克里斯·澀谷，高盛。

Thank you very much. Good morning. On the commercialization effort on the increase in the sales footprint that you have. Can you give us a sense for how maybe more specifically the composition of its group might be able to be impactful? And what's the appropriate way to think about the timing for a potential inflection from.

非常感謝。早安.關於增加您所擁有的銷售足跡的商業化努力。您能否讓我們了解一下，更具體地說，其團隊的組成如何產生影響力？考慮潛在變化的時機的適當方法是什麼？

And then, Frank, I think historically you've acknowledged how AD is a market, certainly quite vast into market to primary care type potential markets that you would contemplate a partnership for that market specifically. Can you talk about what your latest thinking is there? Thank you.

然後，弗蘭克，我認為從歷史上看，您已經認識到AD是一個市場，當然對於初級保健類型的潛在市場來說，您會考慮專門針對該市場建立合作夥伴關係。能談談您的最新想法嗎？謝謝。

Yes, sure. And maybe I'll take the second question first and then I'll ask Todd to talk about the sales force.

是的，當然。也許我會先回答第二個問題，然後我會請托德談談銷售隊伍。

Yeah, yes, you are absolutely correct. You recall correctly our previous comments about half of the atopic dermatitis market and also about half on the seborrheic dermatitis market exist out of dermatology, a lesser portion of the psoriasis market.

是的，是的，你說得完全正確。您正確地記得我們之前關於一半異位性皮膚炎市場和大約一半脂漏性皮膚炎市場存在於皮膚科（牛皮癬市場的較小部分）的評論。

There's not insignificant number of psoriasis patients also treated outside of dermatology. The challenge for the primary care and pediatrics markets, which is where most of those patients said, is just the breadth of the prescriber base. You're talking 250,000 prescribers versus 13,000 prescribers. It's not economically viable for a company like ours to build a primary care sales force.

在皮膚科以外接受治療的乾癬患者也不少。大多數患者表示，初級保健和兒科市場面臨的挑戰只是處方者基礎的廣度。您說的是 25 萬名處方者與 13,000 名處方者。對於像我們這樣的公司來說，建立初級保健銷售團隊在經濟上是不可行的。

And so, we have been saying all along, our intention was to find a partner that had an existing primary-care sales force that could do a co-promote for us in those markets that continues to be our plan. And I would just say at this point that we're in active discussions with potential partners to trying and strike an agreement. We also have said in the past that from a timing standpoint, ideally, we want to have that partnership in place sometime around the atopic dermatitis approval.

因此，我們一直在說，我們的目的是尋找一個擁有現有初級保健銷售團隊的合作夥伴，可以在這些市場上為我們進行共同促銷，這仍然是我們的計劃。我只想說，目前我們正在與潛在合作夥伴進行積極討論，試圖達成協議。我們過去也說過，從時間角度來看，理想情況下，我們希望在異位性皮膚炎獲批前後的某個時間點建立這種夥伴關係。

And I say around because the PCPs are going to be looking to the dermatologist for guidance and so we have to win with the dermatologist first. I don't think we need to have that PCP partnership in place at launch, but you would want to have it sometime shortly after that launch or there wouldn't be any downside to having it before either.

我說左右是因為 PCP 將尋求皮膚科醫生的指導，所以我們必須先贏得皮膚科醫生的支持。我認為我們不需要在發佈時建立 PCP 合作夥伴關係，但您可能希望在發布後不久的某個時間建立這種夥伴關係，否則在此之前建立 PCP 夥伴關係也不會有任何不利影響。

Right. So, I think you should really be thinking it about us hoping to have that in place in the second half of 2022, 2024, excuse me. And then Todd, do you want to talk a little bit the sales force expansion?

正確的。所以，我認為您真的應該考慮一下我們希望在 2022 年下半年、2024 年實現這一目標，對不起。然後托德，您想談談銷售團隊的擴張嗎？

Yeah, relative to the sales force expansion, the 15% increase in share of voice, so that 15%, we picked up 15% and we overlaid the current sales force. What we did is look at the high prescribing geographies to make certain that, we can continue to obtain the desired frequency and reach and engagement with those high-prescribing physicians.

是的，相對於銷售隊伍的擴張，聲音份額增加了 15%，所以 15%，我們提高了 15%，覆蓋了目前的銷售團隊。我們所做的是研究高處方地區，以確保我們能夠繼續獲得所需的頻率、覆蓋率以及與那些高處方醫生的接觸。

So, we overlaid that 15% into those geographies. In addition to that, as we move through 2024, and we, and then the atopic dermatitis launch will at that time give consideration to potentially in another expansion to make certain that we have the share of voice required to be able to engage across the three indications. And don't forget the 2023, Arcutis aligned, a group called the pharmacy access managers within the field.

因此，我們將 15% 覆蓋到這些地區。除此之外，當我們進入 2024 年時，我們以及異位性皮膚炎的推出將在那時考慮可能進行另一次擴展，以確保我們擁有能夠參與這三個領域所需的話語權。跡象。不要忘記 2023 年，Arcutis 共同成立了一個名為該領域藥房准入管理人員的組織。

This team engages directly with the independent or follow pharmacies as well as the staff with the dermatology offices to ensure that we get an appropriate prescription fulfillment. So, I feel that the organizations that are at a very good place right now to have the appropriate share of voice that we need to be able to continue the acceleration of ZORYVE psoriasis and make certain we start from a position of strength and a quick start to the Seb Derm launch.

該團隊直接與獨立或後續藥房以及皮膚科辦公室的工作人員合作，以確保我們獲得適當的處方履行。因此，我認為目前處於非常有利位置的組織能夠擁有適當的話語權，我們需要能夠繼續加速 ZORYVE 牛皮癬的發展，並確保我們從一個強大的位置開始并快速啟動Seb Derm 發布。

And that expansion, we completed October one. So, I mean, I think we'll see some impact even in the fourth quarter, and that will continue on into '24

我們在 10 月完成了這次擴展。所以，我的意思是，我認為即使在第四季度我們也會看到一些影響，而這種影響將持續到 24 年

Yes, absolutely.

是的，一點沒錯。

Great. Thank you. Look forward to the momentum from that new sales force.

偉大的。謝謝。期待新銷售團隊的動力。

Sean Kim, Jones Trading.

肖恩金，瓊斯貿易公司。

Yeah. Hi, congratulations on the quarter and thank you for taking my questions. I guess, so just a few quick questions on my end. So, first question is that's you look to move into government Medicare, Medicaid patient populations. Can you comment on the potential additional operational efforts and maybe financial burden that will be required and to tap into that market and maybe potential sales opportunities there?

是的。您好，恭喜本季取得成功，感謝您回答我的問題。我想，所以我只想問幾個簡單的問題。因此，第一個問題是您希望進入政府醫療保險、醫療補助患者群體。您能否評論一下潛在的額外營運工作以及可能需要的財務負擔以及進入該市場以及那裡潛在的銷售機會？

And my second question is about the sales force expansion, as we look to launch that pyramid. Also, atopic dermatitis. I believe you mentioned about 9,000 unique prescribers that has been prescribed and ZORYVE, so far just wanted to, I hear your thoughts on the efficiency of the sales force (inaudible) It's about a little over 10 prescriptions per prescriber.

我的第二個問題是關於銷售團隊的擴張，因為我們希望推出金字塔。還有異位性皮膚炎。我相信您提到了大約9,000 名已開出處方的獨特處方者和ZORYVE，到目前為止我只是想，我聽到您對銷售人員效率的想法（聽不清）每個處方者大約有10 多張處方。

I'm just wondering, if there's some opportunities to expand the number of prescriptions per prescriber and also the potential expansion to reach that 30,000 target that you mentioned last time around. And that's my last question is about their sale, our loan agreement, the modifications to the financial covenant. I just wanted to make sure that I understand correctly that the original threshold or minimum threshold remains for a year 2025 and 2026. Thank you.

我只是想知道是否有機會擴大每位處方者的處方數量，以及是否有可能擴大到您上次提到的 30,000 份處方。我的最後一個問題是關於他們的出售、我們的貸款協議、財務契約的修改。我只是想確保我正確理解原始閾值或最低閾值在 2025 年和 2026 年仍然有效。謝謝。

Maybe, let me take your second question and then I'll have Todd address your first question and John address the third question. So yes, look, I think with regard to our breadth and depth, we've talked about this for, there are about 13,000 targets that we are targeting with our sales force. They represent over 90% of the relevant prescriptions in dermatology. Out of that 13,000, about 9,000 are currently writing.

也許，讓我回答你的第二個問題，然後我會讓托德回答你的第一個問題，約翰回答第三個問題。所以，是的，看，我認為就我們的廣度和深度而言，我們已經討論過這個問題，我們的銷售人員瞄準了大約 13,000 個目標。它們佔皮膚科相關處方的 90% 以上。在這 13,000 人中，約有 9,000 人目前正在寫作。

So, they're clearly is an opportunity to expand the breadth of our prescribing base, I don't think we will ever get all 13,000 of them because, you have some doctors who are just in ultra conservative and are never going to change from using their old topical steroids. But I think we'll eventually get very high penetration and we've been adding roughly about 500 doctors a month for quite some time now to that prescribing base, I think we were sitting at 7,000.

所以，它們顯然是擴大我們處方基礎廣度的機會，我認為我們永遠不會得到全部 13,000 個處方，因為，有些醫生非常保守，永遠不會改變使用他們的舊外用類固醇。但我認為我們最終會獲得非常高的滲透率，並且在相當長的一段時間內，我們每個月都會增加大約 500 名醫生，以增加處方基礎，我認為我們的醫生數量是 7,000 名。

I think last in the last quarter, right? Something like that. So, we will continue to expand the prescribing base. I'm confident of that. And I think as Todd mentioned, I think the foam could actually help us with that broadening of the prescriber base. And then I think you also are correct that there is an opportunity for a lot of deepening of the prescribing base, if you look at the topical steroid market today compared to the topical nonsteroidal market, the topical steroid market is about 20 times the size of the nonsteroidal market, right?

我認為最後是在最後一個季度，對嗎？類似的事情。因此，我們將繼續擴大處方基礎。我對此很有信心。我認為正如托德所提到的，我認為泡沫實際上可以幫助我們擴大處方者基礎。然後我認為你也是正確的，即有機會深化處方基礎，如果你看看今天的外用類固醇市場與外用非類固醇市場相比，外用類固醇市場的規模約為 20 倍非類固醇市場，對嗎？

So, even doctors who are writing [10s] or eve scrips are probably writing 20 times than in topical steroids. And so there's immense opportunity for us to continue to expand that market and that really gets back to my earlier comment about the conversion.

因此，即使是寫 [10s] 或 eve 筆記的醫生也可能比使用外用類固醇寫了 20 倍。因此，我們有巨大的機會繼續擴大該市場，這確實回到了我之前關於轉換的評論。

We're in early stages of the conversion process, but we're exactly where we'd expect, we would be in terms of conversion and if you look at any number of other markets, you can get a pretty good sense of how that's going to progress in the coming quarters and coming years. And we feel very confident that that conversion will happen as it's happened in other markets just because of the new non steroidal offer doctors and patients so many benefits.

我們正處於轉換過程的早期階段，但我們正是在轉換方面達到了我們的預期，如果您查看許多其他市場，您可以很好地了解這是如何進行的將在未來幾個季度和未來幾年取得進展。我們非常有信心這種轉變將會發生，就像在其他市場發生的那樣，因為新的非類固醇為醫生和患者提供瞭如此多的好處。

Todd, do you want to maybe talk about what sort of the lift looks like for us getting into Medicare and Medicaid, both financially and operationally?

托德，您是否想談談我們進入醫療保險和醫療補助計劃在財務和營運方面有何提升？

Yeah, well Medicare and Medicaid, as I mentioned in the opening remarks, there's approximately 3 million patients that are in play here. And if you think about Seb Derm, it's more so on the Medicare side and an atopic dermatitis on the Medicaid side. We've been actively engaging in the Medicaid space to be able to secure coverage for patients in 2024 preparation for the atopic dermatitis launch.

是的，醫療保險和醫療補助，正如我在開場白中提到的，大約有 300 萬名患者在這裡發揮作用。如果你想到 Seb Derm，它更多的是在醫療保險方面，而異位性皮膚炎則在醫療補助方面。我們一直在積極參與醫療補助領域，以便能夠在 2024 年為異位性皮膚炎推出做準備，為患者提供保險。

In addition to that, on we're having conversations with the big three PBMs relative to the Part D plans in Medicare, with the ambition to secure that coverage in the first half of 2024. I think what's very important to note here, especially with the Medicare, is that or is the Arcutis is a repricing strategy given where our price point is and it's below the CMS specialty tier, we will very likely be able to gain this coverage in Medicare with a nominal impact on our gross-to-net. So, we're actively engaged and others, those conversations are progressing.

除此之外，我們正在與三大 PBM 就 Medicare 的 D 部分計劃進行對話，目標是在 2024 年上半年確保覆蓋範圍。我認為這裡需要注意的非常重要，尤其是Medicare 是或者是Arcutis 是一種重新定價策略，考慮到我們的價格點並且低於CMS 專業級別，我們很可能能夠在Medicare 中獲得此保險，並對我們的毛淨值產生名義上的影響。因此，我們正在積極參與，其他方面的對話也在取得進展。

Let me take that.

讓我來吧。

Yeah. And then if you -- On the SLR covenant, the way it works is, if you were to look at it today. There is a table with specific revenue targets that prior to the amendment we were held to with respect to the loan agreement that's been replaced with an agreement around a plan which we do every year as due course. And there's agreement and approval of that plan by our Board and SLR. And whatever that plan is you apply this 75%. And if we're above the 75% we've met, the covenants is how it mechanically works.

是的。然後如果你——在單反契約上，它的工作方式是，如果你今天看看它。有一個包含具體收入目標的表格，在修訂之前，我們對貸款協議進行了遵守，該目標已被圍繞我們每年按計劃執行的計劃的協議所取代。我們的董事會和 SLR 已同意並批准該計劃。無論那個計劃是什麼，你都應用這 75%。如果我們超過了我們所達到的 75%，契約就是它的機械運作方式。

That concludes the question-and-answer session.

問答環節到此結束。

At this time, I would like to turn the call back to Frank Watanabe for closing remarks.

此時，我想將電話轉回給 Frank Watanabe，讓其致閉幕詞。

Okay. Well, I appreciate everyone making the time to call into our earnings call this quarter, and we look forward to talking to you all, in another quarter with an update on further progress at our Arcutis. Thanks again.

好的。好吧，我感謝大家抽出時間參加本季的財報電話會議，我們期待在下一個季度與大家交談，介紹我們 Arcutis 的進一步進展的最新情況。再次感謝。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝您參加今天的會議。這確實結束了該程式。您現在可以斷開連線。