Journey Medical Corp (DERM) 2023 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to Journey Medical's second quarter 2023 financial results and corporate update conference call. (Operator Instructions) Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. (Operator Instructions)

女士們先生們，謝謝你們的支持。下午好，歡迎參加征程醫療 2023 年第二季財務表現及公司更新電話會議。 （操作員說明）本次電話會議的參與者請注意，本次電話會議的音訊正在透過網路進行現場直播，並且也被錄製用於回放。 （操作員說明）

I would like now to turn the call over to Mr. Matt Blazei of CoreIR, the company's Investor Relations firm. Please go ahead, sir.

我現在想將電話轉給該公司投資者關係公司 CoreIR 的 Matt Blazei 先生。請繼續，先生。

Good afternoon, and thank you for participating in today's conference call. Joining me from Journey Medical Corporation's leadership team are Claude Maraoui, Co-Founder, President, and Chief Executive Officer; Joe Benesch, Interim Chief Financial Officer; Dr. Srinivas Sidgiddi, Vice President, Research and Development. And joining us for the Q&A session will be Dr. Neal Bhatia, Director of Clinical Dermatology at Therapeutics Clinical Research.

下午好，感謝您參加今天的電話會議。與我一起加入 Journey Medical Corporation 領導團隊的還有共同創辦人、總裁兼執行長 Claude Maraoui； Joe Benesch，臨時財務長； Srinivas Sidgiddi 博士，研發副總裁。治療臨床研究臨床皮膚科主任 Neal Bhatia 博士將加入我們的問答環節。

During this call, management will be making forward-looking statements, including statements that address, among other things, Journey Medical's expectations for future performance, operational results, financial condition, and receipt of regulatory approvals. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements.

在本次電話會議中，管理層將做出前瞻性聲明，其中包括涉及 Journey Medical 對未來業績、營運業績、財務狀況和獲得監管批准的預期等的聲明。前瞻性陳述涉及風險和其他因素，可能導致實際結果與這些陳述有重大差異。

For more information about these risks, please refer to the risk factors described in Journeys Medical's most recently filed periodic reports on Form 10-K and Form 10-Q, the Form 8-K filed with the SEC today and the company's press release that accompanies this call, particularly the cautionary statements in it.

有關這些風險的更多信息，請參閱 Journeys Medical 最近提交的表格 10-K 和表格 10-Q 定期報告、今天向 SEC 提交的表格 8-K 以及公司隨附的新聞稿中描述的風險因素這一呼籲，特別是其中的警告性聲明。

Today's conference call includes non-GAAP financial measures that Journey Medical believes can be useful in evaluating its performance. You should not consider this additional information in isolation or as a substitute for results prepared in accordance with GAAP. For a reconciliation of this non-GAAP financial measure to net loss, its most directly comparable GAAP financial measure, please see the reconciliation table located in the company's earnings press release.

今天的電話會議包括非公認會計準則財務指標，Journey Medical 認為這些指標有助於評估其表現。您不應孤立地考慮此附加信息，也不應將其視為根據 GAAP 準備的結果的替代品。有關此非公認會計原則財務指標與淨虧損（其最直接可比較的公認會計原則財務指標）的調節表，請參閱公司收益新聞稿中的調節表。

The content of this call contains time-sensitive information that is accurate only as of today, August 8, 2023. Except as required by law, Journey Medical disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

本次電話會議的內容包含時效性信息，僅截至今天（2023 年 8 月 8 日）準確。除非法律要求，否則 Journey Medical 不承擔公開更新或修改任何信息以反映此後發生的事件或情況的義務。稱呼。

It is now my pleasure to turn the call over to Claude Maraoui, Co-founder, President, and Chief Executive Officer of Journey Medical.

現在我很高興將電話轉接給 Journey Medical 聯合創始人、總裁兼執行長 Claude Maraoui。

Thanks, Matt. Good afternoon. And thanks to everyone for joining our second quarter 2023 conference call and corporate update. This is an exciting time for Journey Medical. Our commercial business has seen a strong rebound this quarter. And as we recently announced, our Phase 3 trials for DFD-29 treatment for rosacea achieved the co-primary and all secondary endpoints with no significant safety issues.

謝謝，馬特。午安.感謝大家參加我們的 2023 年第二季電話會議和公司動態。對於 Journey Medical 來說，這是一個令人興奮的時刻。我們的商業業務本季出現強勁反彈。正如我們最近宣布的，我們的 DFD-29 治療紅斑痤瘡的 3 期試驗實現了共同主要終點和所有次要終點，且沒有重大安全問題。

I will begin by making some brief comments on the clinical trials and will then be joined by our Vice President of Research and Development, Dr. Srini Sidgiddi, who will present this clinical data in greater detail. Immediately following the presentation, we will review our second quarter results and open the line for questions.

我將首先對臨床試驗做一些簡短的評論，然後我們的研發副總裁 Srini Sidgiddi 博士將加入其中，他將更詳細地介紹這些臨床數據。演示結束後，我們將立即回顧第二季的業績並開放提問。

For the benefit of those on the call who are following our slides, please note that those slides will only be used in the section of the call where Dr. Sidgiddi is reviewing the data from the Phase 3 trials.

為了那些正在觀看我們幻燈片的電話會議人員的利益，請注意，這些幻燈片將僅在 Sidgiddi 博士審查 3 期試驗數據的電話會議部分使用。

We are very pleased with the positive results of our two Phase 3 clinical trials evaluating DFD-29 for the treatment of rosacea, which demonstrated statistical superiority over both Oracea and placebo. This is a significant milestone for Journey Medical and potentially the broader dermatology community.

我們對評估 DFD-29 治療紅斑痤瘡的兩項 3 期臨床試驗所取得的積極結果感到非常滿意，該試驗證明了其優於 Oracea 和安慰劑的統計學優勢。對於 Journey Medical 甚至更廣泛的皮膚病學界來說，這是一個重要的里程碑。

There were approximately 4 million prescriptions written for rosacea in 2022 according to Symphony Health prescription data. Based on these positive study results, we plan on submitting a new drug application for DFD-29 in the second half of 2023. If approved by the FDA, we believe that DFD-29 has annual peak sales potential of $300 million globally. With these clinically meaningful outcomes, DFD-29 has the potential to become the new treatment paradigm for the millions of patients suffering from rosacea, as the lowest dose oral minocycline on the market.

根據 Symphony Health 處方數據，2022 年約有 400 萬張治療紅斑痤瘡的處方。基於這些正面的研究結果，我們計劃在2023年下半年提交DFD-29的新藥申請。如果獲得FDA批准，我們相信DFD-29在全球的年高峰銷售潛力將達到3億美元。憑藉這些具有臨床意義的結果，DFD-29 作為市場上最低劑量的口服米諾環素，有可能成為數百萬紅斑痤瘡患者的新治療範例。

The success of the program is a direct result of the exceptional collaboration between Journey Medical, Dr. Reddy's, the investigators, and all the others that have been involved. We believe the potential approval of DFD-29 will be a transformational event for Journey.

該計劃的成功是 Journey Medical、Dr. Reddy's、研究人員以及所有其他參與者之間卓越合作的直接結果。我們相信 DFD-29 的潛在批准將成為 Journey 的轉型事件。

At this point, I would like to turn the call over to Dr. Sidgiddi to discuss the results of the Phase 3 data in more detail. I will follow up to discuss this market opportunity and our strategy on becoming the market leader in this space.

此時，我想將電話轉給 Sidgiddi 博士，更詳細地討論第三階段數據的結果。我將跟進討論這個市場機會以及我們成為該領域市場領導者的策略。

Thank you, Claude. I would like to begin by reviewing the highlights from this Phase 3 for DFD-29 line data readout. I would also like to refer investors to the investor presentation on our website, which we'll have slides supporting my comments here in more detail.

謝謝你，克勞德。我想先回顧一下 DFD-29 線資料讀出第 3 階段的亮點。我還想請投資者參閱我們網站上的投資者演示文稿，我們將在其中提供幻燈片來更詳細地支持我的評論。

Journey Medical, in collaboration with Dr. Reddy's, has conducted two Phase 3 studies for DFD-29. The Phase 3 studies had the following key design elements: each study enrolled approximately 20 patients with moderate to severe papulopustular rosacea in a 3:3:2 randomization to DFD-29, Oracea, placebo. The first study, MVOR-1 enrolled all patients in the USA, while the second study MVOR-2 enrolled patients in a ratio of approximately 70:30 in the US and Germany.

Journey Medical 與 Dr. Reddy's 合作，針對 DFD-29 進行了兩項 3 期研究。 3 期研究有以下關鍵設計要素：每項研究納入約 20 名中度至重度丘疹膿皰性紅斑痤瘡患者，以 3:3:2 隨機分配至 DFD-29、Oracea、安慰劑組。第一項研究 MVOR-1 在美國招募了所有患者，而第二項研究 MVOR-2 在美國和德國以大約 70:30 的比例招募了患者。

Of the total of approximately 640 patients in the two trials, approximately 540 patients were white Caucasians, while approximately 100 patients were of darker skin colors. All the subjects had an IGA grade of three or four and an inflammatory lesion count of 15 to 60 at study entry. Subjects were adequately washed out of any previous medication they were taking before starting this study treatment. Thus, the efficacy seen in these studies can be attributed to this study medication and not to any confounding or previous medication.

兩項試驗總共約 640 名患者，其中約 540 名患者為白人，約 100 名患者為深色膚色。所有受試者在研究開始時的 IGA 等級均為三級或四級，發炎病灶計數為 15 至 60 個。在開始本研究治療之前，受試者已充分清除先前服用的任何藥物。因此，這些研究中看到的療效可歸因於本研究藥物，而不是任何混雜藥物或先前的藥物。

The study treatments were assessed on two co-primary endpoints. First, proportion of subjects with IGA treatment success. Second, reduction in total inflammatory lesion count. The results showed that the DFD-29 was statistically significantly superior to both placebo and Oracea with 16 weeks treatment duration.

研究治療根據兩個共同主要終點進行評估。首先，IGA 治療成功的受試者比例。其次，減少發炎病變總數。結果顯示，在 16 週的治療時間內，DFD-29 在統計上顯著優於安慰劑和 Oracea。

The proportion of subjects that showed IGA treatment success was 65% for DFD-29, 46.1% for Oracea, and 31.2% for placebo in MVOR-1. The p-value for the difference between DFD-29 and Oracea was 0.014, while it was less than 0.001 against placebo.

在 MVOR-1 中，DFD-29 組 IGA 治療成功的受試者比例為 65%，Oracea 組為 46.1%，安慰劑組為 31.2%。 DFD-29 和 Oracea 之間差異的 p 值為 0.014，而與安慰劑相比小於 0.001。

In MVOR-2, the proportion of subjects that showed IGA treatment success was 60.1% for DFD-29, 31.4% for Oracea and 26.8% for placebo. The p-values were less than 0.001 for the DFD-29 against both Oracea and placebo. In MVOR-1, the reduction in total inflammatory lesion count was 21.3 lesions for DFD-29, 15.9 for Oracea and 12.2 lesions for placebo. The p-values were less than 0.001 for DFD-29 against both Oracea and placebo.

在 MVOR-2 中，顯示 IGA 治療成功的受試者比例，DFD-29 組為 60.1%，Oracea 組為 31.4%，安慰劑組為 26.8%。 DFD-29 相對於 Oracea 和安慰劑的 p 值均小於 0.001。在 MVOR-1 中，DFD-29 的總發炎病變計數減少了 21.3 個病變，Oracea 減少了 15.9 個病變，安慰劑減少了 12.2 個病變。 DFD-29 相對於 Oracea 和安慰劑的 p 值均小於 0.001。

In MVOR-2, to the reduction in total inflammatory lesion count was 18.4 lesions for DFD-29, 14.9 lesions for Oracea and 11.1 lesions for placebo. The p-values were less than 0.001 for DFD-29 against both Oracea and placebo. As can be seen from the data, DFD-29 has consistently outperformed both Oracea and placebo on the two key endpoints in both studies, the DFD-29 has shown statistically significant reduction of erythema in both studies compared to placebo. The DFD-29 has also demonstrated statistically significant improvement in quality of life against placebo with regards to two very commonly used quality of life tools: the DLQI: dermatology quality of life index, which is a general quality of life tool used across dermatology trials; and the rosacea specific quality of life tool, RosaQoL, that is rosacea quality of life.

在 MVOR-2 中，DFD-29 的總發炎病變計數減少了 18.4 個病變，Oracea 減少了 14.9 個病變，安慰劑減少了 11.1 個病變。 DFD-29 相對於 Oracea 和安慰劑的 p 值均小於 0.001。從數據中可以看出，DFD-29在兩項研究中的兩個關鍵終點上始終優於Oracea和安慰劑，與安慰劑相比，DFD-29在兩項研究中都顯示出統計上顯著的紅斑減少。 DFD-29 也證明，在兩種非常常用的生活品質工具方面，與安慰劑相比，DFD-29 在統計上顯著改善了生活品質：DLQI：皮膚科生活品質指數，這是皮膚科試驗中使用的通用生活品質工具；以及紅斑痤瘡特定生活品質工具 RosaQoL，即紅斑痤瘡生活品質。

Finally, we are pleased to say that DFD-29 also has shown rapid onset of action. That is, it has shown statistically superior efficacy or placebo on both IGA success and lesion count reduction from week two onwards, which is a very significant achievement considering these were monotherapy studies. On the safety front, DFD-29 was found to be safe and well-tolerated in both the studies with the adverse event rates being close to placebo.

最後，我們很高興地說 DFD-29 也顯示出快速起效。也就是說，從第二週開始，它在 IGA 成功和病灶計數減少方面顯示出統計上優於安慰劑的療效，考慮到這些是單一療法研究，這是一個非常重大的成就。在安全性方面，兩項研究均發現 DFD-29 是安全的且耐受性良好，不良事件發生率接近安慰劑。

These results indicate the possibility of the DFD-29 being the new standard of care in rosacea and also being the best-in-class therapy. It is likely to be perceived as a safe minocycline formulation compared to other formulations, because of the low and fixed dose. We anticipate DFD-29 to capture significant market share upon its launch based on the significant differentiators it brings to the table.

這些結果表明 DFD-29 有可能成為紅斑痤瘡的新護理標準，也是同類最佳的療法。與其他製劑相比，由於劑量低且固定，它可能被認為是安全的米諾環素製劑。基於 DFD-29 帶來的顯著差異化優勢，我們預期 DFD-29 在推出後將佔據重要的市場份額。

I will now hand it back to Claude to discuss our second fiscal quarter results in more detail. Thank you.

我現在將把它交還給克勞德，更詳細地討論我們第二財季的業績。謝謝。

Thank you, Dr. Sidgiddi. I would like now to turn our attention to the improving results in our commercial operations for the second quarter. As discussed on our last call with investors, our objective was to see continued sequential growth in revenues throughout this year, and to achieve positive non-GAAP adjusted EBITDA for fiscal year 2023. The key metrics for the second quarter surpassed our internal expectations, generating $17.2 million in net revenue, which corresponds to a remarkable 41% sequential gain over Q1 2023.

謝謝你，西吉迪博士。現在我想將注意力轉向第二季商業營運的改善結果。正如我們上次與投資者電話會議中討論的那樣，我們的目標是今年全年收入持續環比增長，並在2023 財年實現非GAAP 調整後EBITDA 為正值。第二季度的關鍵指標超出了我們的內部預期，產生了淨收入為 1,720 萬美元，比 2023 年第一季環比增長 41%。

Some key highlights to note, worthy of mentioning: our leading core product, Qbrexza, led the way with net sales of $8 million in Q2 compared to $4 million in Q1, which is an outstanding 97% increase in addition to achieving a new quarterly all-time high for the brand.

值得注意的一些關鍵亮點，值得一提的是：我們領先的核心產品Qbrexza 在第二季度以800 萬美元的淨銷售額領先，而第一季為400 萬美元，除了實現新的季度總銷售額外，也實現了97% 的驚人增長。- 該品牌的歷史新高。

Accutane, currently our second highest volume core product in our portfolio, had an impressive gain as well. Accutane had net sales of $5.5 million in Q2 versus net sales of $4.6 million in Q1 of 2023, which is a 20% increase. In our third and fourth position of priority, we saw sequential increases in Amzeeq's net revenue of 15% and Zilxi of 82% versus their Q1 results. We expect these trends to continue as we build momentum.

目前我們產品組合中產量第二高的核心產品 Accutane 也取得了令人印象深刻的成長。 Accutane 在第二季的淨銷售額為 550 萬美元，而 2023 年第一季的淨銷售額為 460 萬美元，成長了 20%。在我們的第三和第四個優先位置上，我們看到 Amzeeq 的淨收入比第一季的業績連續成長了 15%，Zilxi 的淨收入成長了 82%。我們預計，隨著我們勢頭的增強，這些趨勢將持續下去。

Our legacy brands, which are Exelderm, Targadox, and Ximino continue to see anticipated erosion and combined only account for 8% of our total revenue in Q2 2023. I'd like to congratulate our commercial sales and marketing teams for remaining focused and executing our strategic plan.

我們的傳統品牌 Exelderm、Targadox 和 Ximino 繼續遭受預期的侵蝕，在 2023 年第二季度合計僅占我們總收入的 8%。我要祝賀我們的商業銷售和營銷團隊保持專注並執行我們的計劃戰略計劃。

Journey continues making great strides towards the guidance that we gave during our 2022 10-K earnings call, in which, is achieving non-GAAP adjusted EBITDA positive for calendar year 2023. Our entire organization has taken the necessary steps and becoming more efficient and optimizing our business goals. A key example of this effort is limiting our SG&A spend. Journey has successfully reduced SG&A expenses in Q2 2023 by over $3 million compared to Q2 2022.

Journey 繼續朝著我們在2022 年10-K 財報電話會議中給出的指導方向邁進，其中，2023 年將實現非GAAP 調整後EBITDA 為正值。我們的整個組織已採取必要的步驟，變得更加高效和優化我們的業務目標。這項努力的一個重要例子是限制我們的銷售、管理和行政費用。與 2022 年第二季相比，Journey 在 2023 年第二季成功減少了 SG&A 費用超過 300 萬美元。

We remain steadfast in our efforts and are well on track of achieving a projected reduction of over $12 million in SG&A spend this calendar year. Important to note, not only have we been able to implement the appropriate expense reduction efforts, we also were able to achieve revenue growth in parallel. We are certainly trending towards meeting our financial objectives and continue to expect this trend to continue into the second half of 2023.

我們仍然堅定不移地努力，並有望實現今年 SG&A 支出預計減少超過 1200 萬美元。值得注意的是，我們不僅能夠實施適當的費用削減措施，而且還能夠同時實現收入成長。我們當然傾向於實現我們的財務目標，並繼續預計這一趨勢將持續到 2023 年下半年。

Finally, I am pleased to announce that we have paid off the entire debt facility we had with East West Bank. Journey now has zero bank debt.

最後，我很高興地宣布，我們已經還清了華美銀行的全部債務融資。 Journey 現在的銀行債務為零。

With that, I'll now turn the call over to Jo, who will review our financial results for the second quarter.

現在，我將把電話轉給喬，他將審查我們第二季的財務表現。

Thank you, Claude, and hello, everyone. I will now review the second quarter financial results for 2023. As Claude mentioned, total net revenues for the second quarter of 2023 were $17.2 million, 41% increase from $12.2 million in the first quarter and a slight decrease of $1.1 million from the prior year quarter. The decrease from the prior year quarter is primarily due to lower unit volumes from our legacy products: Targadox, Ximino, and Exelderm; substantially driven by continued generic competition for Targadox. These results were offset by an increase in net product revenues from our four core products: Qbrexza, Accutane, Amzeeq, and Zilxi. Primarily due to increased unit volumes as a result of our focused sales and marketing emphasis on these products, which led to 19% growth for these products combined from the prior year quarter.

謝謝克勞德，大家好。 I will now review the second quarter financial results for 2023. As Claude mentioned, total net revenues for the second quarter of 2023 were $17.2 million, 41% increase from $12.2 million in the first quarter and a slight decrease of $1.1 million from the prior year四分之一.與去年同期相比下降的主要原因是我們傳統產品的單位銷售減少：Targadox、Ximino 和 Exelderm；很大程度上是由 Targadox 的仿製藥持續競爭推動的。這些結果被我們四個核心產品的淨產品收入的成長所抵消：Qbrexza、Accutane、Amzeeq 和 Zilxi。主要是由於我們對這些產品的集中銷售和行銷重視導致單位銷售增加，這導致這些產品的總銷售量比去年同期增加了 19%。

These products combined reflect approximately 92% or $15.6 million of the company's total product revenues for the second quarter of 2023. R&D expenses decreased by 32% from the prior year quarter related to lower clinical trial expenses for DFD-29 as the project winds down.

這些產品合計約占公司 2023 年第二季產品總收入的 92%（即 1,560 萬美元）。隨著計畫結束，DFD-29 的臨床試驗費用減少，研發費用比去年同期下降了 32%。

SG&A expenses decreased by 20% from the prior year quarter. The decrease is mainly due to our expense reduction efforts, primarily in sales and marketing. During the last quarter of 2022, we implemented a cost reduction initiative designed to improve operational efficiencies, optimize expenses, and reduce overall costs. The initiative is intended to reduce SG&A expenses to better align costs with revenues being generated.

SG&A 費用較去年同期下降 20%。減少的主要原因是我們努力削減開支，主要是在銷售和行銷方面。在 2022 年最後一個季度，我們實施了一項成本削減計劃，旨在提高營運效率、優化費用並降低整體成本。該計劃旨在減少銷售、管理和行政費用，以更好地調整成本與產生的收入。

In connection with this cost reduction initiative, we executed a headcount reduction to our sales force and implemented marketing and other cost cuts. The impact of this cost reduction initiative is expected to result, as Claude mentioned, in a reduction of greater than $12 million of annual SG&A expenses.

為了配合這項降低成本的舉措，我們削減了銷售人員的人數，並實施了行銷和其他成本削減。正如 Claude 所提到的，這項成本削減措施的影響預計將導致年度 SG&A 費用減少超過 1,200 萬美元。

In the second quarter of 2023, we recorded $3.1 million noncash impairment loss towards Ximino intangible asset. Based on Ximino's current net product revenue and gross profit levels, we revised the financial outlook for Ximino, resulting in lower projected sales and net cash flows for future periods. We assess this revised forecast and determine that the revision constituted a triggering event. We reviewed the undiscounted future cash flows identified for Ximino, and the results of the analysis indicated that the carry amount of the Ximino intangible asset on our balance sheet is not expected to be recovered.

2023 年第二季度，我們對 Ximino 無形資產記錄了 310 萬美元的非現金減損損失。根據 Ximino 目前的淨產品收入和毛利水平，我們修訂了 Ximino 的財務前景，從而降低了未來期間的預期銷售額和淨現金流量。我們評估了這項修訂後的預測，並確定該修訂構成了觸發事件。我們審查了 Ximino 確定的未折現未來現金流量，分析結果表明，我們資產負債表上的 Ximino 無形資產的帳面金額預計不會收回。

GAAP net loss to common shareholders was $8.4 million or $0.46 per share, basic and diluted for the second quarter of 2023, compared to a GAAP net loss of $10.1 million or $0.57 per share, basic and diluted for the first quarter of 2023, from $7.5 million $0.43 per share, basic and diluted for the second quarter of 2022.

2023 年第二季普通股股東的GAAP 淨虧損為840 萬美元，即基本和稀釋後每股0.46 美元，而2023 年第一季GAAP 淨虧損為1,010 萬美元，即基本和稀釋後每股0.57 美元，較7.5 美元2022 年第二季的基本和稀釋每股收益為 0.43 美元。

Our non-GAAP adjusted EBITDA for the second quarter of 2023 resulted in a net loss of $600,000 or $0.04 per share basic and diluted, compared to an adjusted EBITDA net loss of $5.3 million or $0.30 per share basic and diluted for the first quarter of 2023, and an adjusted EBITDA net loss of $2.6 million or $0.15 per share basic and diluted for the second quarter of 2022. We are well on our way to becoming non-GAAP adjusted EBITDA positive in 2023.

2023 年第二季的非GAAP 調整後EBITDA 淨虧損為60 萬美元，即基本和稀釋每股虧損0.04 美元，而2023 年第一季調整後EBITDA 淨虧損為530 萬美元，即基本和稀釋每股虧損0.30 美元，2022 年第二季調整後 EBITDA 淨虧損為 260 萬美元，即每股基本虧損和攤薄虧損 0.15 美元。我們正朝著 2023 年非 GAAP 調整後 EBITDA 為正值的目標邁進。

At June 30, 2023, we had $17 million in cash and cash equivalents and restricted cash, as compared to $26.1 million at March 31, 2023. At December 31, 2022, we had $32 million in cash and cash equivalents. From the cash burn perspective, in May 2023, we paid down $10 million of our term loan and our $3 million revolver with East West Bank.

截至2023年6月30日，我們擁有1700萬美元的現金和現金等價物以及限制性現金，而2023年3月31日為2610萬美元。截至2022年12月31日，我們擁有3200萬美元的現金和現金等價物。從現金消耗的角度來看，2023 年 5 月，我們償還了華美銀行 1,000 萬美元的定期貸款和 300 萬美元的左輪手槍。

Subsequently, in July of 2023, we voluntarily paid off the entire $10 million outstanding East West bank term loan, effectively terminating the entire East West Bank facility. We therefore have no further obligations to East West Bank. We were able to pay off all of our East West Bank debt without any additional dilution to the company. Thank you very much, and now I'll turn it back to Claude.

隨後，我們於 2023 年 7 月自願償還了華美銀行未償還的全部 1000 萬美元定期貸款，有效終止了整個華美銀行貸款。因此，我們對華美銀行沒有進一步的義務。我們能夠償還華美銀行的所有債務，而不會對該公司造成任何額外的稀釋。非常感謝，現在我將把它轉回給克勞德。

Thank you, Jo. In summary, I'd like to recap the highlights discussed on today's call. First, DFD-29 achieved outstanding results. DFD-29 showed superiority to current standard of treatment or ratio. We met all primary and secondary endpoints. The NDA filing in Q4 2023 is on schedule. Our Phase 1 sub anti-microbial data suggests suitable long term usage. And if approved, DFD-29 has sales potential over $300 million globally.

謝謝你，喬。總之，我想回顧一下今天電話會議討論的要點。首先，DFD-29取得了突出的成績。 DFD-29 顯示優於目前的治療或比率標準。我們達到了所有主要和次要終點。 2023 年第四季的新藥申請 (NDA) 申請如期進行。我們的第一階段亞抗菌數據顯示適合長期使用。如果獲得批准，DFD-29 在全球的銷售潛力將超過 3 億美元。

Second, our Q2 2023 financial results rebounded from Q1. In Q2, we were up 41% over Q1, net sales. Over 90% of revenue in our core four promoted products. Third, the East West Bank full debt payoff happened in July. We are confident in our ability to have enough cash to see DFD-29 through approval.

其次，我們 2023 年第二季的財務表現較第一季反彈。第二季度，我們的淨銷售額比第一季成長了 41%。超過90%的收入來自我們的四大核心推廣產品。第三，華美銀行7月全額償債。我們有信心有能力擁有足夠的現金來讓 DFD-29 獲得批准。

Fourth, we are targeting operational profitability, non-GAAP adjusted by end of this year, 2023. The R&D expenses winding down with completion of our Phase 3 studies.

第四，我們的目標是到 2023 年底調整非 GAAP 營運獲利能力。隨著第三階段研究的完成，研發費用逐漸減少。

And finally in fifth, our BD team continues to be opportunistic in looking at various commercial stage assets to add to our portfolio. Plus, we look forward and continuing to work on out-licensing efforts with our current product portfolio and as well as with DFD-29 and its successful Phase 3 trials. We look forward to sharing our ongoing progress for both our commercial and clinical business when we report our third quarter results in November.

最後，我們的 BD 團隊繼續機會主義地尋找各種商業階段資產以添加到我們的投資組合中。此外，我們期待並繼續致力於我們目前的產品組合以及 DFD-29 及其成功的第 3 階段試驗的對外許可工作。我們期待在 11 月報告第三季業績時分享我們商業和臨床業務的持續進展。

Thank you, and have a good day.

謝謝你，有美好的一天。

We will now begin the question and answer session. (Operator Instructions)

我們現在開始問答環節。 （操作員說明）

Scott Henry, Roth Capital.

史考特·亨利，羅斯資本。

Thank you. Good afternoon. Tremendous improvement from the first quarter. I'm sure it was tough making a lot of those cuts, but I do think it was instrumental to making the company viable in the long term. So I commend you and your team on that, Claude.

謝謝。午安.較第一季有龐大進步。我確信進行大量裁員是很困難的，但我確實認為這對於使公司長期生存至關重要。所以我讚揚你和你的團隊，克勞德。

Shifting gears, and I'm going to start with the quarter, then I do have some DFD-29 questions. First, my assumption would be that when you paid off the loan, that was all out of restricted cash. Is that correct?

換個主題，我將從本季開始，然後我確實有一些 DFD-29 問題。首先，我的假設是，當你還清貸款時，所有的資金都是受限的。那是對的嗎？

Joe, would you like to take that, please?

喬，你願意接受這個嗎？

Yeah. Hi, Scott. We had $8.75 million of restricted cash on the books, and it was definitely paid off with that.

是的。嗨，斯科特。我們帳上有 875 萬美元的限制性現金，而且肯定已經得到了回報。

Okay. Excellent. And then, your target of being EBITDA positive for the year still requires a lot of work because you got to make money in the second half, but you also have to work down some of the loss you started with in the first quarter. To do that, do you expect that to be driven by higher revenues or lower expenses or a little bit of both?

好的。出色的。然後，你今年實現 EBITDA 為正值的目標仍然需要做很多工作，因為你必須在下半年賺錢，但你還必須減少第一季開始時的一些虧損。為此，您預計這將由收入增加或費用減少或兩者兼而有之推動？

Yeah, (multiple speakers) Go ahead, Joe, please.

是的，（多個發言者）請繼續，喬。

It's going to be a little bit of both, Scott. The second quarter still had some residual expenses in there from the cuts, right? So April and May still had some higher expenses in there. So third quarter, fourth quarter are going to show the true cuts. And also from a revenue standpoint, we expect to be sequentially better.

斯科特，兩者都有一點。第二季仍有一些削減帶來的剩餘費用，對嗎？所以四月和五月仍然有一些較高的費用。所以第三季、第四季將顯示真正的削減。而且從收入的角度來看，我們預計會持續更好。

Okay, great. I now just want to shift to DFD-29. You told us what your peak sales would be. Could you comment on how long you expect it to take to reach peak sales? This category, does it tend to be rapid uptake? Or what kind of trajectory do you typically see?

好的，太好了。我現在只想轉向 DFD-29。您告訴我們您的峰值銷售額是多少。您能否評論一下您預計需要多長時間才能達到銷售高峰？這個品類是否會被快速吸收？或者你通常看到什麼樣的軌跡？

Sure, Scott. Yeah. In terms of uptake and launching DFD-29, we plan on doing that in early 2025, a few months after we get approval, hopefully from the FDA. In terms of how quickly to the peak sales numbers, typically you're going to be looking between two to three years as the peak annual sales ramp up.

當然，斯科特。是的。在 DFD-29 的採用和上市方面，我們計劃在 2025 年初，也就是我們獲得 FDA 批准的幾個月後進行。就達到銷售高峰的速度而言，通常您需要兩到三年的時間才能達到年度銷售高峰。

We're going to be looking at this asset going head-to-head using what we hope to be a very rich package insert that the FDA has approved will be able to go, and start to change the habits of utilizing Oracea as the gold standard and starts to switch that over to DFD-29.

我們將使用 FDA 批准的非常豐富的包裝說明書來研究這項資產，並開始改變使用 Oracea 作為黃金的習慣標準並開始將其切換到 DFD-29。

What's key with this asset is, the ability of us not just sticking in the oral systemic marketplace, but this drug candidate, DFD-29 has the ability to go into the topical market, which has a much greater potential. So you're looking at 4 million prescriptions written last year; oral and topical. And that market is right in our sweet spot. We call on doctors that prescribe Oracea. We already cover 90% of those that are currently prescribing Oracea in the last 12 months, to give you some background.

這項資產的關鍵在於，我們不僅有能力堅持口服系統市場，而且這種候選藥物 DFD-29 有能力進入具有更大潛力的局部市場。所以你會看到去年開出的 400 萬張處方；口服和局部。這個市場正是我們的最佳選擇。我們呼籲開 Oracea 處方的醫生。我們已經涵蓋了過去 12 個月內正在服用 Oracea 的 90% 的患者，為您提供一些背景資訊。

Okay. And just following up on that, because I think you're correct. I believe the rosacea market about 90% topical and maybe 10% oral, which is Oracea. In the acne market, orals have done very well. If we think about the acne market, what percent is oral versus topical, so we get a sense of the ability to expand into that topical market with a better product offering.

好的。並繼續跟進，因為我認為你是對的。我相信紅斑痤瘡市場大約 90% 是外用的，也許 10% 是口服的，即 Oracea。在痤瘡市場上，口服藥做得非常好。如果我們考慮痤瘡市場，口服與外用的比例是多少，這樣我們就會感覺到有能力透過提供更好的產品擴展到外用市場。

Yeah. In terms of the number off the top of my head, I can get back to you on the exact size of oral versus topical in the acne arena. But you're right about that the percentage holds true on the rosacea side. So about 360,000 prescriptions, 400,000 prescriptions for Oracea last year and about 3.6 million of the topicals. So very close to those percentages.

是的。就我頭頂上的數字而言，我可以告訴你口服與外用在痤瘡領域的確切大小。但你說得對，這個百分比在紅斑痤瘡方面也是正確的。去年大約有 36 萬個處方，其中 40 萬個 Oracea 處方，以及約 360 萬個外用藥。非常接近這些百分比。

Okay. And then just the final question on the balance sheet. How comfortable are you with your cash balance? Obviously, at the right time, you would probably consider raising some more equity. But I'm trying to get a sense of how flexible are you? Are you comfortable that you don't have to raise it down here and you may have a path to get pretty close to breakeven from here as well?

好的。然後是資產負債表上的最後一個問題。您對現金餘額感到滿意嗎？顯然，在適當的時候，您可能會考慮籌集更多股權。但我想了解你的靈活性如何？您是否感到放心，您不必在此處提高價格，並且您也有可能從這裡開始接近盈虧平衡？

Yeah, I'll start with this one, Joe. Yeah. So far, like you said, we've had an exceptional second quarter. We've really cut our losses dramatically. Adjusted EBITDA at $600,000. So the breakeven is within a throw away. So we expect to be able to continue with operations. We're not looking to raise any equity funding whatsoever. We are looking at debt facilities. Certainly I think that would be proper to do. But right now, in terms of being operationally profitable, we're at that point where our revenues and where our SG&As falling allows us the ability to go for all the way through the end of 2024 as a matter of fact, Scott.

是的，我將從這個開始，喬。是的。到目前為止，正如您所說，我們的第二季度表現非常出色。我們確實大幅減少了損失。調整後 EBITDA 為 600,000 美元。因此，盈虧平衡已近在咫尺。因此，我們希望能夠繼續運作。我們不打算籌集任何股權融資。我們正在考慮債務融資。當然，我認為這樣做是正確的。但目前，就營運獲利而言，我們正處於收入和銷售管理費用下降的階段，事實上，我們有能力一直持續到 2024 年底，史考特。

Okay, great. I'll jump back in the queue. Thank you for taking the questions.

好的，太好了。我會跳回到隊列中。感謝您提出問題。

Kalpit Patel, B. Riley.

卡爾皮特·帕特爾，B.萊利。

Yeah. Hey. Good afternoon. And congrats on clearing the Phase 3 studies for DFD-29.

是的。嘿。午安.恭喜 DFD-29 的三期研究順利通過。

Maybe I'll start with a couple of questions on this asset. You obviously beat both placebo and Oracea in the Phase 3 studies. Maybe give us a sense of how reflective were the patients enrolled in the trial compared to the real-world population and that gets Oracea today.

也許我會先問幾個關於這個資產的問題。在 3 期研究中，您顯然擊敗了安慰劑和 Oracea。也許可以讓我們了解參與試驗的患者與現實世界人群相比的反思程度如何，這就是今天奧拉西亞的情況。

Sure. I'll tell you, I think Dr. Sidgiddi could take that and talk about the inclusion criteria of real world types of patients. And we also have a guest investigator dermatologist, Dr. Neal Bhatia, and perhaps he can follow up to Dr. Srini's comments.

當然。我告訴你，我認為 Sidgiddi 博士可以接受這一點並談論現實世界類型患者的納入標準。我們還有一位客座研究員皮膚科醫生 Neal Bhatia 博士，也許他可以跟進 Srini 博士的評論。

Thanks, Claude. And that's a great question, Kalpit. The inclusion exclusion criteria that we had on these studies were very much reflective of the real world population for rosacea. The kind of IGA grades and the lesion counts at baseline that we used, those are the common kind of patients that providers see when they have to describe an oral drug.

謝謝，克勞德。這是一個很好的問題，卡爾皮特。我們對這些研究的納入排除標準在很大程度上反映了現實世界中的紅斑痤瘡族群。我們使用的 IGA 分級類型和基線病變計數是提供者在描述口服藥物時遇到的常見患者類型。

Having said that, I will transfer the question to Neal. Neal, could you please explain it a little more?

話雖如此，我會把問題轉給尼爾。尼爾，你能再解釋一下嗎？

Yeah, hi there. Can you guys hear me okay?

是的，你好。你們聽得到我說話嗎？

Yes, we can.

我們可以。

Hai everybody. Scott. I'm Dr. Neal Bhatia. I am in San Diego. I was one of the investigators for the study. I've worked with Journey as well as Dr. Reddy's Labs for many years just as a side. I think commercially, as a dermatologist, we have not been seeing much support of Oracea from Galderma, neither their generic nor their branded in the past year or so due to their inability to cover the market. That in turn led to a downturn in the amount of oral treatments for rosacea that have been considered to be safe or effective.

大家好。斯科特.我是尼爾‧巴蒂亞博士。我在聖地牙哥。我是這項研究的調查員之一。我作為輔助人員與 Journey 以及 Dr. Reddy's Labs 合作了很多年。我認為在商業上，作為一名皮膚科醫生，我們在過去一年左右的時間裡沒有看到 Galderma 對 Oracea 的太多支持，無論是他們的仿製藥還是他們的品牌，因為他們無法覆蓋市場。這反過來又導致了被認為安全或有效的紅斑痤瘡口服治療藥物數量的下降。

By contrast, we've seen an upturn in the amount of topical products like Epsolay, [demise of] Soolantra and metronidazole. But even though sales are flat. And I think to the point that commercially, we see a lot of rosacea patients who are tired of applying bad vehicles to their face, which is already hypersensitive. They're concerned about the photosensitivity of higher doses of antibiotics like doxycycline. And minocycline, until now, unfortunately, a lot of the brands have fell by the wayside.

相較之下，我們看到 Epsolay、Soolantra 和甲硝唑等外用產品的數量增加。但儘管銷量持平。我認為，在商業上，我們看到很多紅斑痤瘡患者厭倦了在臉上使用劣質的車輛，而臉部已經非常敏感。他們擔心高劑量抗生素（如強力黴素）的光敏感性。而米諾環素，不幸的是，到目前為止，很多品牌都已經被淘汰了。

So seeing this dose of minocycline come to fruition as well as what we saw in the trials, I think this could actually have a very strong foothold in gaining that spot for oral treatment as a standard. I think the other component to rosacea patients is, many of them are otherwise healthy. They're not on other medications. They again would prefer a pill and something orally to minimize the labor involved with treating topically. So I think some of those would fit very well into the potential for the rosacea market. I know that a lot of our trial patients did not want to let this drug go out of their hands. They were so pleased with the way things turned out for them that they were actually sad the trial ended.

因此，看到這種劑量的米諾環素取得成果以及我們在試驗中看到的結果，我認為這實際上可以為獲得口服治療標準奠定了堅實的基礎。我認為紅斑痤瘡患者的另一個組成部分是，他們中的許多人在其他方面都很健康。他們沒有服用其他藥物。他們再次更喜歡藥物和口服藥物，以盡量減少局部治療所需的勞力。所以我認為其中一些非常適合酒渣鼻市場的潛力。我知道我們的許多試驗患者都不想讓這種藥物失控。他們對事情的結果非常滿意，以至於審判結束後他們實際上感到悲傷。

Okay, understood. And Dr. Bhatia, since we have you here today, I guess, can you give us an understanding of how minocycline capsules maybe used today in the market for rosacea, are there they used commonly as an off-label treatment? And is it more or less reserved just for Oracea?

好的，明白了。 Bhatia 博士，既然您今天來到這裡，我想您能否讓我們了解一下目前市場上如何使用米諾環素膠囊來治療紅斑痤瘡，它們是否通常用作標籤外治療？它或多或少是專門為奧拉西亞保留的嗎？

Yeah. I mean the -- let me set back -- tetracycline family as a whole impacts a number of processes that start the inflammatory cascade of rosacea. That's been understood for many years in terms of different proteins that get cleaved, the [taxicyclin] pathway and without getting too scientific, a lot of the cell lines that are progressing the process of rosacea.

是的。我的意思是——讓我回顧一下——四環素家族作為一個整體會影響許多引發紅斑痤瘡發炎級聯的過程。多年來，人們已經透過裂解的不同蛋白質、[紫杉環素]途徑來了解這一點，並且在沒有太科學的情況下，許多正在進展為紅斑痤瘡過程的細胞系。

So both doxycycline and minocycline have been proven effective at an optimal dose; because for one, there's no bacterial targets. So there's no action as an antibiotic. It's more an anti-inflammatory dose. But the problem is above a certain threshold, the medication, whether it's doxycycline or minocycline, can have antibiotic properties which can lead to consequence down the road, which is what led to the cultivation of Oracea at that dosage.

因此，多西環素和米諾環素均已被證明在最佳劑量下有效。因為一方面，沒有細菌目標。所以沒有抗生素的作用。它更像是一種抗炎劑量。但問題是超過了一定的閾值，藥物，無論是多西環素還是米諾環素，都可能具有抗生素特性，這可能會導致後果，這就是導致以該劑量種植 Oracea 的原因。

Now the way minocycline will work at this dosage in the DFD-29 product will be in a very similar directed fashion against the process that makes rosacea, and the safety of it will allow it to be used -- again, your lung if you will, whatever indication comes from it. The long-term study is for 52 weeks. And everything else that goes along with this class of drugs tells us that we have a safety profile we can rely on.

現在，米諾環素在DFD-29 產品中的這種劑量的作用方式將以非常相似的定向方式對抗紅斑痤瘡的產生過程，並且它的安全性將允許它被使用——再說一次，如果你願意的話，你的肺，無論從中得到什麼指示。長期研究為期52週。與此類藥物相關的所有其他資訊都告訴我們，我們擁有值得信賴的安全性。

So I think in the end, rosacea patients -- you think about your average 30-some-year old, they have a high co-pay, high deductible. I'd rather treat them with something that I know will work for the long run, and not have to see them back in the office to fine tune them, and let them do well on the medication that's going to serve the purpose of treating the process of their disease, not just the symptoms.

所以我認為最後，紅斑痤瘡患者——想想普通的 30 歲左右的人，他們有很高的共付額、高免賠額。我寧願用我知道會長期有效的方法來治療他們，而不必看到他們回到辦公室對他們進行微調，並讓他們在藥物治療上表現良好，從而達到治療的目的他們的疾病過程，而不僅僅是症狀。

I hope that makes sense. I didn't want to make it too scientific for you.

我希望這是有道理的。我不想讓它對你來說太科學。

No, that's helpful. And this one, I believe, is an extended release or a special formulation of minocycline. Do you see any advantages here in terms of the safety profile or tolerability profile versus just using a generic immediate release minocycline tablets or capsules?

不，這很有幫助。我相信，這是米諾環素的緩釋劑或特殊製劑。與僅使用通用速釋米諾環素片劑或膠囊相比，您認為在安全性或耐受性方面有什麼優勢嗎？

Minocycline is a synthetic drug compared to doxycycline, which is natural. So doxycycline's effects are more immediate. They cause headaches, photosensitivity, GI distress. Minocycline, over the long term, at high doses can cause vertigo, and lupus like effects, and kidney issues and things that are dose limiting at higher doses. So with this dose, we are less likely to see any long-term chronic issues that were once a stigma related to higher doses of minocycline.

米諾環素是一種合成藥物，而多西環素是天然藥物。因此強力黴素的效果更為直接。它們會引起頭痛、光過敏、胃腸道不適。從長遠來看，高劑量的米諾環素會引起眩暈、狼瘡樣作用、腎臟問題以及高劑量時劑量限制的問題。因此，在這個劑量下，我們不太可能看到任何長期慢性問題，而這些問題曾經是與高劑量米諾環素相關的恥辱。

So minocycline by nature, is better absorbed in the fat and the pilosebaceous unit and the middle layers of the skin, which is why it was always a better drug for acne than doxycycline. From a logistics standpoint, and this might sound selfish, as dermatologists always looked at minocycline as our drug, because a lot of the primary care physicians and others who were treating rosacea and acne, they were sending the patients to us on doxy and we'd say, well, let's switch it up. So there's going to be a little bit of possession that dermatologists will feel when they get their hands on this.

因此，米諾環素本質上可以更好地被脂肪、毛囊皮脂腺單位和皮膚中層吸收，這就是為什麼它始終是比多西環素更好的治療痤瘡的藥物。從後勤的角度來看，這可能聽起來很自私，因為皮膚科醫生總是將米諾環素視為我們的藥物，因為許多初級保健醫生和其他治療紅斑痤瘡和痤瘡的醫生，他們將患者送到我們這裡使用多西，我們'我會說，好吧，我們換個方式吧。因此，當皮膚科醫生拿到這個產品時，他們會有一點佔有欲。

Got it. And maybe one last market opportunity related question here for you, doctor. Assuming this drug gets approved, what proportion of your rosacea patients would you prescribe this drug? And what proportion will you continue to use Oracea?

知道了。醫生，也許還有最後一個與市場機會相關的問題。假設這種藥物獲得批准，您會給多少比例的紅斑痤瘡患者開這種藥？您將繼續使用 Oracea 的比例是多少？

Well, sure. I mean, I'll be honest, I'm an early adopter. So when I get something new and I get my hands on something, I pretty much flood everybody with it. There are going to be those who might be tied to Oracea, there are going to be others who will take a chance on minocycline. And in all fairness, there's probably going to be a few dermatologists who say, no, I'm not comfortable with minocycline.

嗯，當然。我的意思是，說實話，我是早期採用者。因此，當我得到一些新東西並得到一些東西時，我幾乎會用它淹沒每個人。將會有一些人可能與奧拉西亞有關，也會有其他人會冒險服用米諾環素。平心而論，可能會有一些皮膚科醫生說，不，我對米諾環素感到不舒服。

So all of that will be up to Journey to bring all those mindsets forward and approach the marketing that way. I'm an educator myself, I speak at conferences on rosacea and published textbooks. I would have no problem talking about safety first, and talking about here's an efficacious approach to the process of rosacea with an oral route, and I would probably work on convincing my colleagues to maybe get off the ledge rather than be concerned with what we used to know about your father's minocycline, if you want to call it that.

因此，這一切都將取決於 Journey 能否將所有這些思維方式向前推進並以這種方式進行行銷。我自己也是一名教育家，我在紅斑痤瘡會議和出版的教科書中發表演講。我毫無疑問地先談論安全，並談論這是一種透過口服途徑治療紅斑痤瘡的有效方法，我可能會努力說服我的同事擺脫困境，而不是擔心我們使用的東西了解你父親的米諾環素（如果你想這麼稱呼的話）。

Okay. And maybe one question for the company. The clinical trial itself, how did erythema fare in both of your studies? I believe in Oracea's pivotal studies back in the day, we saw a statistically significant improvement, at least in one of those two studies for erythema. Could we see that here as well?

好的。也許還有一個問題想問公司。臨床試驗本身，紅斑在你們的兩項研究中表現如何？我相信在 Oracea 當年的關鍵研究中，我們看到了統計上顯著的改善，至少在這兩項紅斑研究中的一項是如此。我們在這裡也能看到這一點嗎？

Srini, can you take that one, please?

斯里尼，你能拿走那個嗎？

Sure, Claude. Kalpit, you are right. Back in those days, Oracea had a statistical significance against placebo on erythema in one of their studies, while the other one didn't show this significance. But during the NDA review process, I think the FDA did find out from their own end that there was no significance on both the studies. Now coming back to our studies, we did study the impact on erythema as an important secondary endpoint, and we found that both the studies have shown statistical significance against placebo for DFD-29. But that's going to be one of our key messages on the NDA filing.

當然，克勞德。卡爾皮特，你是對的。當時，在他們的一項研究中，Oracea 與安慰劑相比在紅斑方面具有統計顯著性，而另一項研究則沒有顯示出這種顯著性。但在NDA審查過程中，我認為FDA確實從自己的角度發現這兩項研究沒有任何意義。現在回到我們的研究，我們確實研究了對紅斑的影響作為重要的次要終點，我們發現這兩項研究都顯示出 DFD-29 相對於安慰劑的統計顯著性。但這將是我們在 NDA 備案中傳達的關鍵訊息之一。

Okay.

好的。

And if I could add to that just real quick. All of that is correct. The clinical erythema assessment that is done when you walk in the door as an investigator is often a marker of overall success. Keep in mind that's -- the patient, their number one concern is looking less red. So when you're looking at them, when you walk in the door to assess their grading. the erythema assessment is included in your overall grade of improvement, even though the papulo and pustular count is still one of the more objective measures.

如果我能很快補充的話。所有這些都是正確的。當您作為調查員走進大門時進行的臨床紅斑評估通常是整體成功的標誌。請記住，對於患者來說，他們最關心的問題是看起來不那麼紅。因此，當您看著他們時，當您走進門評估他們的評分時。儘管丘疹和膿皰數仍然是更客觀的衡量標準之一，但紅斑評估仍包含在您的整體改善等級中。

So keep in mind, if people are not getting less red as a result of the post-inflammatory erythema or the background erythema, they're going to let you know.

因此請記住，如果人們沒有因發炎後紅斑或背景紅斑而變得不那麼紅，他們會讓您知道。

Okay. Thank you very much for taking the questions.

好的。非常感謝您接受提問。

(Operator Instructions) With no further questions, this will conclude our question-and-answer session. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

（操作員說明）沒有其他問題，我們的問答環節就結束了。會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。