Journey Medical Corp (DERM) 2023 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by and good afternoon, and welcome to Journey Medical's third-quarter 2023 financial results and corporate update conference call. (Operator Instructions)

女士們、先生們，感謝大家的耐心等待，下午好，歡迎參加 Journey Medical 2023 年第三季財務業績和公司最新情況電話會議。 （操作員說明）

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. A webcast replay of the call will be available approximately one hour after the end of the call for approximately 30 days.

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。通話結束後約 1 小時將提供通話的網路廣播重播，持續約 30 天。

I would now like to turn the call over to Jaclyn Jaffe, the company's Senior Director of Corporate Operations. Please go ahead, Jaclyn.

我現在想將電話轉給該公司企業營運資深總監 Jaclyn Jaffe。請繼續，傑克琳。

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; Joseph Benesch, Interim Chief Financial Officer; Dr. Srinivas Sidgiddi, Vice President of Research and Development; and Ramsey Alloush, General Counsel and Corporate Secretary, who will be joining for the Q&A portion of the call.

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； Joseph Benesch，臨時財務長； Srinivas Sidgiddi 博士，研發副總裁；總法律顧問兼公司秘書 Ramsey Alloush 將參加電話會議的問答部分。

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 the receipt of regulatory approvals. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors described in Journey Medical's most recently filed periodic report 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.

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。有關這些風險的更多信息，請參閱 Journey 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 以及該公司的新聞稿中描述的風險因素伴隨這一呼籲，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, November 7, 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 11 月 7 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, Jacqueline. Good afternoon and thanks to everyone for joining our third-quarter 2023 conference call and corporate update. Let me begin by saying that Q3 2023 continues to be a very positive and evolving time for Journey Medical. Our focus during our second year as a public company is to achieve profitability from our commercial operations.

謝謝，杰奎琳。下午好，感謝大家參加我們的 2023 年第三季電話會議和公司動態。首先我要說的是，2023 年第三季對 Journey Medical 來說仍然是一個非常積極且不斷發展的時期。作為上市公司的第二年，我們的重點是從商業營運中實現盈利。

To achieve this, we have been working with three critical factors. The first is driving net revenue for our four core brands: Qbrexza, Accutane, Amzeeq, and Zilxi. The second is optimizing and reducing our SG&A. And the third is building out our portfolio through licensing and acquisition, while advancing our DFD-29 product candidate for rosacea.

為了實現這一目標，我們一直在努力解決三個關鍵因素。首先是推動我們四個核心品牌的淨收入：Qbrexza、Accutane、Amzeeq 和 Zilxi。第二是優化和減少我們的 SG&A。第三是透過授權和收購來建立我們的產品組合，同時推進我們針對紅斑痤瘡的 DFD-29 候選產品。

In the third quarter of 2023, our total net revenues, which included the Maruho out-licensing upfront payment, was $34.5 million, which is an increase of 101% from $17.2 million in the second quarter and an increase of 114% from $16.1 million in the third quarter of 2022.

2023 年第三季度，我們的總淨收入（包括 Maruho 對外許可預付款）為 3,450 萬美元，比第二季度的 1,720 萬美元增長 101%，比去年同期的 1,610 萬美元增長 114%。2022 年第三季。

As evidenced by our most recent transaction, we believe that Qbrexza as well as our patented products, including DFD-29, are extremely attractive near-term opportunities for those companies looking to exclusively in-license our products in other countries.

正如我們最近的交易所證明的那樣，我們相信 Qbrexza 以及我們的專利產品（包括 DFD-29）對於那些希望在其他國家獨家授權我們產品的公司來說是極具吸引力的近期機會。

We previously gave guidance in March of this year that we expected our SG&A expense to be reduced by $12 million for 2023 compared to 2022. Through our financially disciplined approach, we are raising our guidance to reduce SG&A expense by approximately $17 million for 2023 compared to 2022.

我們先前曾在今年3 月給予指導，預計2023 年的SG&A 費用將比2022 年減少1200 萬美元。透過我們嚴格的財務紀律方法，我們正在提高指導，將2023 年的SG&A 費用比2022 年減少約1700 萬美元。 2022 年。

Regarding our clinical development asset that is being evaluated for the treatment of rosacea, DFD-29, we are encouraged by the recent positive top-line results, demonstrating statistically superior efficacy over rosacea and placebo in the two Phase 3 clinical trials.

關於我們正在評估用於治療紅斑痤瘡的臨床開發資產DFD-29，我們對最近積極的頂線結果感到鼓舞，在兩項3 期臨床試驗中顯示出在統計學上優於紅斑痤瘡和安慰劑的療效。

We remain on track to submit a new drug application to the FDA for DFD-29 around the end of this year. We believe that the opportunity to enhance patient care for those who suffer from rosacea with a potentially best-in-class therapy will be appealing to both patients as well as medical providers who treat this type of condition.

我們仍有望在今年底左右向 FDA 提交 DFD-29 新藥申請。我們相信，透過潛在的最佳療法來加強對紅斑痤瘡患者的患者護理的機會對於患者以及治療此類疾病的醫療提供者都有吸引力。

In terms of prescription market size, there were approximately $4 million prescriptions written for rosacea in 2022, according to Symphony Health prescription data. If approved by the FDA, we believe that DFD-29 has annual peak net sales potential in excess of $300 million globally.

根據 Symphony Health 處方數據，就處方市場規模而言，2022 年紅斑痤瘡處方約為 400 萬美元。如果獲得 FDA 批准，我們相信 DFD-29 在全球的年高峰淨銷售潛力將超過 3 億美元。

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 well as the lowest dose oral minocycline on the market. We believe that the potential approval and commercial launch of DFD-29 will be a transformational event for both Journey and the broader dermatology community.

憑藉這些具有臨床意義的結果，DFD-29 有潛力成為數百萬紅斑痤瘡患者的新治療範例，以及市場上最低劑量的口服米諾環素。我們相信，DFD-29 的潛在批准和商業推出對於 Journey 和更廣泛的皮膚病學界來說都將是一次變革性事件。

At this point, I would like to turn the call over to Dr. Srinivas Sidgiddi to discuss our DFD-29 clinical program in greater detail.

此時，我想將電話轉給 Srinivas Sidgiddi 博士，更詳細地討論我們的 DFD-29 臨床計劃。

Thank you, Claude, and hello, everyone. I would like to begin by reviewing the highlights from the Phase 3 studies for DFD-29. I'd also like to refer investors to the investor presentation on our website, which contains the slides supporting my remarks here in more detail.

謝謝克勞德，大家好。我想先回顧一下 DFD-29 第三階段研究的亮點。我還想請投資者參閱我們網站上的投資者演示文稿，其中包含更詳細地支持我的言論的幻燈片。

Journey Medical, in collaboration with Dr. Reddy's, has recently conducted and completed two pivotal Phase 3 studies for the DFD-29. Both studies had the following key design elements. Each study enrolled approximately 320 patients with moderate to severe rosacea in a 3:3:2 randomization for DFD-29 Oracea or placebo.

Journey Medical 與 Dr. Reddy's 合作，最近進行並完成了 DFD-29 的兩項關鍵的 3 期研究。這兩項研究都有以下關鍵設計要素。每項研究均以 3:3:2 隨機分組方式招募了大約 320 名中度至重度紅斑痤瘡患者，接受 DFD-29 Oracea 或安慰劑治療。

The first study, MVOR-1, enrolled patients solely in the US. While the second study, MVOR-2, enrolled patients in a ratio of approximately 70:30 in the US and Germany. All subjects had moderate to severe rosacea at entry.

第一項研究 MVOR-1 僅在美國招募病患。第二項研究 MVOR-2 在美國和德國以約 70:30 的比例入組患者。所有受試者在進入時均患有中度至重度酒渣鼻。

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 the study medication and not to any confounding or previous medication.

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. The first, proportion of subjects with IGA treatment success; the second, reduction in total inflammatory lesion count. In addition, the study had bio secondary endpoints that were adjusted for multiplicity, meaning that there is a possibility of being included in the label upon FDA approval if the results are statistically superior to placebo.

研究治療根據兩個共同主要終點進行評估。第一，IGA 治療成功的受試者比例；第二，減少發炎病變總數。此外，該研究的生物次要終點已針對多重性進行了調整，這意味著如果結果在統計上優於安慰劑，則有可能在 FDA 批准後被納入標籤中。

The results for the co-primary and all five secondary endpoints demonstrated that DFD-29 was statistically significantly superior to both placebo and Oracea with 16 weeks treatment duration. 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.

共同主要終點和所有五個次要終點的結果表明，DFD-29 在 16 週的治療持續時間內在統計學上顯著優於安慰劑和 Oracea。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 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。

In MVOR-1, the reduction in total inflammatory lesion count was minus 21.3 of DFD-29, minus 15.9 for Oracea, and minus 12.2 for placebo. The p-values were less than 0.001 for DFD-29 against both Oracea and placebo.

在 MVOR-1 中，DFD-29 的總發炎病灶計數減少了負 21.3，Oracea 為負 15.9，安慰劑為負 12.2。 DFD-29 相對於 Oracea 和安慰劑的 p 值均小於 0.001。

In MVOR-2, the reduction in total inflammatory lesion count was minus 18.4 for DFD-29, minus 14.9 for Oracea, and minus 11.1 for placebo. The p-values with less than 0.001 for DFD-29 against both Oracea and placebo.

在 MVOR-2 中，DFD-29 的總發炎病灶計數減少為負 18.4，Oracea 為負 14.9，安慰劑為負 11.1。 DFD-29 相對於 Oracea 和安慰劑的 p 值小於 0.001。

As can be seen from the data, DFD-29 consistently outperformed both Oracea and placebo on the two co-primary endpoints in both studies. One of the important secondary endpoints was erythema reduction. Because erythema, that is redness, happens to be one of the important signs relevant to both providers and their patients.

從數據中可以看出，在兩項研究的兩個共同主要終點上，DFD-29 始終優於 Oracea 和安慰劑。重要的次要終點之一是紅斑減少。因為紅斑，即發紅，恰好是與提供者及其患者相關的重要徵兆之一。

The proportion of subjects that showed [EE] success, that is erythema success, was 31.7% for DFD-29 and 13.8% for placebo in MVOR-1. The p-value for the difference between DFD-29 and placebo was 0.006.

在 MVOR-1 中，DFD-29 組顯示 [EE] 成功（即紅斑成功）的受試者比例為 31.7%，安慰劑組為 13.8%。 DFD-29 和安慰劑之間差異的 p 值為 0.006。

In MVOR-2, the proportion of subjects that showed EE success was 24.5% for DFD-29 and 12% for placebo. The p-value was 0.023 for the difference between DFD-29 and placebo.

在 MVOR-2 中，DFD-29 組顯示 EE 成功的受試者比例為 24.5%，安慰劑組為 12%。 DFD-29 和安慰劑之間差異的 p 值為 0.023。

If approved, the significant impact on erythema reduction is expected to result in a unique differentiator on the label. And DFD-29 is likely to be the first oral therapy with an indication for the treatment of inflammatory lesions and erythema of rosacea. While most other therapies approved for rosacea have either treatment of inflammatory lesions or treatment of erythema on their labels, but not both.

如果獲得批准，對減少紅斑的顯著影響預計將在標籤上產生獨特的差異化優勢。而DFD-29很可能是第一個適應症為治療紅斑性痤瘡發炎病變和紅斑的口服療法。雖然大多數批准用於紅斑痤瘡的其他療法在其標籤上要么治療炎症病變，要么治療紅斑，但不是兩者兼而有之。

DFD-29 has also demonstrated statistically significant improvement in quality of life against placebo with regards to both DLQI and RosaQoL, two widely accepted tools for quality of life assessment in dermatology. We are encouraged by the DFD-29 safety profile that was demonstrated in both of the studies with the adverse event rate being close to placebo.

DFD-29 也證明，與安慰劑相比，在 DLQI 和 RosaQoL 方面，DFD-29 在統計上顯著改善了生活質量，這兩種廣泛接受的皮膚科生活品質評估工具。我們對兩項研究中證明的 DFD-29 安全性感到鼓舞，不良事件發生率接近安慰劑。

These results indicate the possibility of DFD-29 being the new standard of care in rosacea and also being the best-in-class therapy with head-to-head superiority for the current standard scale. Additionally, it is likely to be perceived as a potentially safer minocycline compared to other oral minocycline therapies because of the low and fixed daily dose.

這些結果表明 DFD-29 有可能成為紅斑痤瘡的新治療標準，並且也成為當前標準量表中具有頭對頭優勢的同類最佳療法。此外，由於每日劑量低且固定，與其他口服米諾環素療法相比，它可能被認為是一種潛在更安全的米諾環素。

We anticipate DFD-29 to capture significant market share upon this launch based on the significant differentiators demonstrated in the Phase 3 study.

基於第 3 階段研究中所顯示的顯著差異化因素，我們預期 DFD-29 在此次推出後將佔據重要的市場份額。

The most recent update on DFD-29 is from October 2023, where we had a product to pre-NDA meeting with the FDA for DFD-29. We expect to provide an update following receipt of the FDA meeting minutes.

DFD-29 的最新更新是從 2023 年 10 月開始，當時我們與 FDA 就 DFD-29 舉行了 NDA 前會議。我們希望在收到 FDA 會議記錄後提供最新情況。

Thank you very much. And now I'll hand it to Joe to discuss our third-quarter financial results in greater detail.

非常感謝。現在我將把它交給喬更詳細地討論我們第三季的財務表現。

Thank you, Dr. Sidgiddi, and hello, everyone. I will now review the third-quarter financial results for 2023. Total net revenues for the third quarter were $34.5 million, 101% increase from $17.2 million in the second quarter and an $18.4 million or 114% increase from the prior-year quarter due to our most recent out-licensing agreement with Maruho.

謝謝西吉迪博士，大家好。我現在回顧一下2023 年第三季的財務表現。第三季的總淨收入為3,450 萬美元，比第二季的1,720 萬美元成長101%，比去年同期成長1,840 萬美元，成長114%，原因是我們最近與 Maruho 簽訂的對外授權協議。

Net product sales were $15.3 million for the third quarter, a slight decrease of $800,000 from $16 million in the third quarter of 2022. The decrease is primarily due to lower net revenue from [Ximino] resulting from lower unit volumes due to the winding down of the product during the third quarter. We discontinued selling the Ximino on September 29th, 2023.

第三季產品淨銷售額為1,530 萬美元，比2022 年第三季的1,600 萬美元小幅減少80 萬美元。這一下降主要是由於[Ximino] 的淨收入下降，這是由於[Ximino] 的停業而導致單位銷售量下降。第三季的產品。我們於 2023 年 9 月 29 日停止銷售 Ximino。

The decrease was partially offset by an increase in net product revenues from Accutane, Amzeeq, and Zilxi due to our continued sales and marketing emphasis on these products. Our four core products: Qbrexza, Accutane, Amzeeq, and Zilxi all acquired and launched since 2022 represent approximately 90% or $13.8 million of our total net product revenue for the third quarter of 2023.

由於我們持續重視 Accutane、Amzeeq 和 Zilxi 的銷售和行銷，這些產品的淨收入增加部分抵消了這一下降。我們自 2022 年以來收購和推出的四種核心產品：Qbrexza、Accutane、Amzeeq 和 Zilxi 約占我們 2023 年第三季產品總淨收入的 90% 或 1,380 萬美元。

Cost of goods sold decreased by $800,000 or 11% to $6.4 million for the third quarter of 2023 from $7.2 million for the third quarter of 2022. The decrease is substantially due to the contractual royalty percentage reduction on Qbrexza net sales from period to period.

銷售成本從2022 年第三季的720 萬美元下降到2023 年第三季的640 萬美元，下降了80 萬美元，即11%。這一下降主要是由於Qbrexza 淨銷售額的合約特許權使用費百分比在不同時期下降。

Research and development expenses decreased by $600,000 compared to the prior-year quarter due to lower DFD-29 expenses as the clinical development activities continue to wind down. SG&A expenses decreased by $7 million or 45% from the prior-year quarter. The decrease is mainly due to our expense reduction efforts primarily in sales and marketing.

與去年同期相比，研發費用減少了 60 萬美元，因為隨著臨床開發活動繼續減少，DFD-29 費用減少。 SG&A 費用比去年同期減少 700 萬美元，即 45%。減少的主要原因是我們主要在銷售和行銷方面努力削減開支。

As we have discussed in prior quarter calls, during the last quarter of 2022, we implemented a cost reduction initiative designed to improve operational efficiencies, optimize expenses, and reduce overall costs. As demonstrated by SG&A expense in Q3, our efforts have proven to be effective.

正如我們在上一季度電話會議中討論的那樣，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、優化費用並降低總體成本。正如第三季的 SG&A 費用所證明的那樣，我們的努力被證明是有效的。

Our efforts have proven to be effective. The impact of these cost reduction initiatives is expected to result in a reduction of approximately $17 million of annual SG&A expenses, surpassing our earlier target of $12 million.

事實證明，我們的努力是有效的。這些成本削減措施的影響預計將導致年度 SG&A 費用減少約 1,700 萬美元，超過我們先前 1,200 萬美元的目標。

The company recorded GAAP net income of $16.8 million or $0.91 per share basic and $0.80 per share diluted for the third quarter of 2023 compared to a GAAP net loss of $8.4 million or $0.46 per share, basic and diluted, for the second quarter of 2023. And a GAAP net loss of $10.1 million or $0.57 per share basic and diluted for the third quarter of 2022. As you can see, the company has made significant strides and continues to improve its operating performance.

該公司2023 年第三季的GAAP 淨利為1,680 萬美元，即基本每股收益0.91 美元，稀釋每股收益0.80 美元，而2023 年第二季的GAAP 淨虧損為840 萬美元，即基本每股收益和稀釋每股收益 0.46 美元。2022 年第三季的GAAP 淨虧損為1010 萬美元，即基本虧損和稀釋每股虧損0.57 美元。如您所見，該公司已取得重大進展，並繼續改善其經營業績。

The company's non-GAAP adjusted EBITDA for the third quarter of 2023 resulted in income of $20.8 million or $1.13 per share basic and $0.99 per share diluted compared to an adjusted EBITDA net loss of $600,000, or $0.04 per share basic and diluted for the second quarter of 2023. And an adjusted EBITDA net loss of $4 million or $0.23 per share basic and diluted for the third quarter of 2022. We expect that the company will be non-GAAP adjusted EBITDA positive for the full-year 2023.

該公司2023 年第三季的非GAAP 調整後EBITDA 營收為2,080 萬美元，即基本每股收益1.13 美元，稀釋每股收益0.99 美元，而第二季調整後EBITDA 淨虧損為60 萬美元，即基本每股收益和稀釋每股收益0.04 美元2023 年的調整後EBITDA 淨虧損為400 萬美元，即2022 年第三季基本虧損和稀釋後每股虧損0.23 美元。我們預計，該公司2023 年全年將實現非GAAP 調整後EBITDA 為正值。

At September 30, 2023, we had $24.8 million in cash and cash equivalents compared to $32 million of cash and cash equivalents at December 31, 2022. As a result of our recent payoff of the EWB debt facility, the company no longer has any debt obligations.

截至2023 年9 月30 日，我們擁有2,480 萬美元的現金和現金等價物，而截至2022 年12 月31 日，我們擁有3,200 萬美元的現金和現金等價物。由於我們最近還清了EWB 債務融資，該公司不再有任何債務義務。

Thank you very much. And now I will turn it back to Claude.

非常感謝。現在我將把它轉回給克勞德。

Thank you, Joe. The positive momentum is evident and is expected to continue into the final quarter of 2023. We believe that this momentum is further reflected by our stock price performance, which, as of yesterday, is up approximately 70% year to date.

謝謝你，喬。這種積極勢頭是顯而易見的，預計將持續到 2023 年最後一個季度。我們相信，這種勢頭進一步反映在我們的股價表現上，截至昨天，今年迄今已上漲約 70%。

I'd like to close the call by reminding everyone that November is Hyperhidrosis Awareness Month. A key initiative at Journey is to continue to build disease state awareness, education, and the treatment options that Qbrexza offers for patients suffering from this condition.

在結束這通電話時，我想提醒大家，十一月是多汗症意識月。 Journey 的一項關鍵舉措是繼續提高疾病狀態意識、教育以及 Qbrexza 為患有這種疾病的患者提供的治療選擇。

Thank you and have a good day. I will now turn the call back over to the operator.

謝謝你，有美好的一天。我現在將把電話轉回給接線生。

(Operator Instructions)

（操作員說明）

Scott Henry, Roth Capital.

史考特·亨利，羅斯資本。

Thank you. Good afternoon and congratulations. A lot of progress on the income statement, a lot of progress in the pipeline, so great job there.

謝謝。下午好，恭喜你。損益表取得了許多進展，管道中也取得了許多進展，工作非常出色。

A couple of questions. And when we think about Q4, Q3, just trying to get a sense of how we should think about that, both from a revenue standpoint, and as well that SG&A, do you think you can cut it? I mean it was 8.6 in Q3. Is there more? Is it going lower than that? Or are we kind of at a steady state at this point?

有幾個問題。當我們考慮第四季度、第三季時，只是想了解我們應該如何考慮這一點，無論是從收入的角度還是從銷售管理費用的角度來看，你認為你可以削減它嗎？我的意思是第三季是 8.6。還有更多嗎？會比這個更低嗎？或者我們目前處於穩定狀態嗎？

Hey, Scott, good to hear your voice. I'll take a part of this question in terms of Q4 and how that's going to reflect comparing it to a Q3 here. We're one month into the fourth and final quarter of the year; we've got good momentum. The prescriptions look solid and I would expect a very strong quarter similar to what you see in Q3 so far.

嘿，斯科特，很高興聽到你的聲音。我將從第四季度的角度來回答這個問題，以及如何將其與第三季進行比較。今年第四季也是最後一個季度已經過了一個月；我們勢頭良好。這些處方看起來很可靠，我預計季度會非常強勁，與迄今為止第三季的情況類似。

And then in terms of our SG&A efforts and operating efficiencies, I'm going to have Joe jump in here and give you this take.

然後就我們的銷售、一般行政費用（SG&A）工作和營運效率而言，我將請喬（Joe）跳到這裡來為您做這個。

Sure. Thanks, Claude. And how you doing, Scott? So from an SG&A standpoint, Scott, we should be pretty even with the third quarter. There's a chance we could be a little bit better. But from our expectations now, I would definitely keep it even with the third quarter.

當然。謝謝，克勞德。你好嗎，斯科特？因此，從 SG&A 的角度來看，斯科特，我們第三季的業績應該相當平衡。我們有機會做得更好一點。但從我們現在的預期來看，即使是第三季度，我也肯定會保持它。

Okay. Great.

好的。偉大的。

Our guidance fix with our -- that's $17 million.

我們的指導方針是 1700 萬美元。

Okay. Fantastic. And then any color on Accutane and Qbrexza? I know you mentioned if you combine them all together, but any surprises there? Or did they -- I mean, I would guess it looked kind of similar to last year, but just any color on those two?

好的。極好的。那麼 Accutane 和 Qbrexza 有顏色嗎？我知道你有提到如果你把它們結合在一起，但是有什麼驚喜嗎？或者他們——我的意思是，我猜它看起來和去年有點相似，但那兩個只是任何顏色？

Yeah. In terms of Accutane, I think we're very pleased with how the product is performing. I think from a sales and marketing end, the message is getting out there. I think more and more patients and physicians are turning to the brand Accutane.

是的。就維他命A酸而言，我認為我們對該產品的表現非常滿意。我認為從銷售和行銷的角度來看，訊息正在傳播出去。我認為越來越多的患者和醫生正在轉向 Accutane 品牌。

So we like where we are. Right now, we have approximately a 14.5% market share. So in no ways have we come close to hitting our ceiling. And we've got a lot of emphasis with the sales force right now on that particular brand.

所以我們喜歡我們現在的處境。目前，我們的市佔率約為 14.5%。因此，我們還遠遠沒有達到上限。現在我們的銷售人員非常重視這個特定的品牌。

So in terms of Qbrexza, there is seasonality for this brand. We're heading into the winter right now, so there can be some offsets with that. But generally, I would anticipate a very similar solid quarter in Q4 as you've seen in the Q3 here with Qbrexza.

所以就Qbrexza而言，這個品牌是有季節性的。我們現在正進入冬天，所以可能會有一些抵消。但總的來說，我預計第四季度會有一個非常相似的穩定季度，就像您在 Qbrexza 的第三季度中看到的那樣。

Okay. Great. Final question just on DFD-29. The rosacea data was pretty compelling, pretty big potential product particularly relative to the size of the company, Journey, is today. Although a lot more today than three months ago.

好的。偉大的。關於 DFD-29 的最後一個問題。紅斑痤瘡數據非常引人注目，是相當大的潛在產品，特別是相對於 Journey 公司今天的規模。雖然今天比三個月前多了許多。

The question is: do you get incoming calls on that asset? I mean, is it possible that someone may do an offer you couldn't refuse that you would look at partnering that and perhaps in bigger hands? Or do you even consider that? Thanks.

問題是：您是否接到該資產的來電？我的意思是，是否有人可能會提出一個你無法拒絕的要約，你會考慮與之合作，也許是在更大的手中？或者你甚至考慮過這一點嗎？謝謝。

Sure. Yes, Scott. Great question. You know, with the results that came out, the Phase 3 results that came out in early July, it certainly has caught a lot of attention from the industry as well as a lot of interested parties and potentially licensing the asset from us outside of the country here in the US.

當然。是的，斯科特。很好的問題。你知道，隨著結果的公佈，7月初公佈的第三階段結果，它肯定引起了業界以及許多感興趣的各方的廣泛關注，並有可能在外部許可我們的資產。美國這裡的國家。

In terms of would we ever entertain any sort of potential offer for the asset? You know, I think it's all in what the offers look like. We're always open. We're very opportunistic when it comes to business development. And we've always got an open ear.

我們是否會接受任何形式的潛在資產報價？你知道，我認為這一切都取決於報價的樣子。我們始終保持開放。在業務發展方面，我們非常注重機會主義。我們始終保持開放的態度。

But right now, we are really focused on continuing to execute and make sure we have all the launch plans ready to really hit the door running once we get the approval hopefully in the latter half of 2024. So all hands are on deck and that's as much as I could say.

但現在，我們真正專注於繼續執行，並確保我們已準備好所有發射計劃，一旦我們希望在 2024 年下半年獲得批准，就能真正開始運行。所以，所有人都準備好了，那就是我能說的就這麼多。

Okay, great. Thank you for taking the questions.

好的，太好了。感謝您提出問題。

Andrew Fleszar, B. Riley.

安德魯·弗萊斯扎，B.萊利。

Hey, good afternoon and thank you for taking questions. A few from us. Starting with DFD-29, what market research may be emerging ahead of the NDA and the potential launch there? And have you sampled prescribers to get a better understanding of the drug's potential positioning in the market?

嘿，下午好，感謝您提出問題。我們的一些。從 DFD-29 開始，在 NDA 和潛在發布之前可能會出現哪些市場研究？您是否對處方者進行了抽樣調查，以便更好地了解該藥物在市場上的潛在定位？

Sure, Andy, thanks for the question. Yeah. Previously, we've already conducted some market research specifically with payers to really examine the price sensitivity, for example, and potential contracting requirements that would be needed.

當然，安迪，謝謝你的提問。是的。此前，我們已經專門針對付款人進行了一些市場研究，以真正檢查價格敏感性，例如，以及可能需要的潛在合約要求。

Now we want to revalidate that and we've got additional research that's being conducted as we speak. Some of the areas are -- in terms of looking at Oracea where it's contracted, potential generics to ratio, and what that means to the marketplace, as well as considerations of the perceptions of our providers.

現在我們想重新驗證這一點，並且我們正在進行更多研究。其中一些領域是——就 Oracea 的簽約地點、潛在的仿製藥比例、這對市場意味著什麼，以及對我們供應商看法的考慮而言。

So how does DFD-29, this modified minocycline release, once a day, that will have hopefully a very unique indication for anti-inflammatory and erythema associated to Oracea? And we want to get aided and unaided qualifications from our customers.

那麼，DFD-29（這種改良的米諾環素每天釋放一次）如何有望為 Oracea 相關的抗發炎和紅斑提供非常獨特的適應症？我們希望從客戶那裡獲得有幫助和無幫助的資格。

So we want to look at all sorts of factors. And like I said, we really want to understand and validate our adoption and our peak demand for this particular product and then how long it will take for that peak to come.

所以我們要考慮各種因素。就像我說的，我們真的想了解和驗證我們對這個特定產品的採用和高峰需求，以及該高峰到來需要多長時間。

So we have great assumptions. We've already validated a lot of this with previous market research. But now with the studies conducted and complete, and now we're doing additional research.

所以我們有很好的假設。我們已經透過先前的市場研究驗證了這一點。但現在隨著研究的進行和完成，我們正在做更多的研究。

Okay, great. We'll look forward to some of the results there, and that's in your prepared remarks. It sounds like erythema may be included in the label. Can you elaborate on that at all?

好的，太好了。我們期待那裡的一些結果，這在你準備好的評論中。聽起來紅斑可能包含在標籤中。能詳細說明一下嗎？

Sure. I'm going to have Dr. Srinivas talk about that a little bit.

當然。我將請斯里尼瓦斯博士談談這個問題。

Thanks, Claude, and thanks, Andy, for that question. That's a very good question. The thing that I would like to say about erythema is that erythema happens to be one of the secondary endpoints that we had on the Phase 3 studies.

謝謝克勞德，也謝謝安迪提出這個問題。這是一個非常好的問題。關於紅斑，我想說的是，紅斑恰好是我們第三階段研究的次要終點之一。

And the secondary endpoints were adjusted for multiplicity, which means that if there is statistical superiority to placebo, there is a very high chance of that endpoint ending up on the label. So since it was a multiplicity of secondary endpoint and it was agreed with the FDA in terms of where it would be placed in the hierarchy, we believe that we have a good chance of getting that on the label.

次要終點根據多重性進行了調整，這意味著如果在統計上優於安慰劑，則該終點最終出現在標籤上的可能性非常高。因此，由於它是多個次要終點，並且就其在層次結構中的位置與 FDA 達成了一致，我們相信我們有很好的機會將其放在標籤上。

Excellent. That's very helpful. And now switching gears, one final question for me on Accutane. It sounds like you're having continued growth in market share at 14.5%. But I know that we had a bit of a slowdown in isotretinoin market overall last year.

出色的。這非常有幫助。現在換個話題，這是我關於Accutane 的最後一個問題。聽起來您的市佔率持續成長，達到 14.5%。但我知道去年異維A酸市場整體放緩。

Have they kind of return to the expected long-term growth rate there? And any additional color you can provide on the overall market?

他們是否已經恢復到預期的長期成長率？您可以在整個市場上提供任何其他顏色嗎？

Sure. Yeah. Andy, just to give you some market background on the isotretinoin market, in 2021, and that's all isotretinoins included. There is about 2,075,000 prescriptions. And in 2022, about the same amount. And now in 2023 through the first three quarters, we're at about 1.5 million and change.

當然。是的。安迪，我只是向您介紹 2021 年異維A酸市場的一些市場背景，其中包括所有異維A酸。大約有 2,075,000 個處方。到 2022 年，數量大約相同。現在到 2023 年前三個季度，我們的人數約為 150 萬，並且會有所改變。

So it looks like is going to be up close to that 2 million prescription market. There was a touch of a slowdown. But I think we're starting to see that ramp back up. So it's holding very strongly. I think we saw some good single digits year over year. That's just backed off a bit, but it's very nominal.

因此，看起來將接近 200 萬份處方藥市場。有一點放緩的感覺。但我認為我們開始看到這種勢頭有所回升。所以它的持有力非常強。我認為我們逐年看到了一些不錯的個位數。這只是稍微退縮了一點，但這是非常名義上的。

Great. Thanks for the additional color, and thank you for taking the questions.

偉大的。感謝您提供額外的顏色，並感謝您提出問題。

Sure. Absolutely.

當然。絕對地。

This concludes our question-and-answer session as well as our call for today. Thank you for attending today's presentation. You may now disconnect.

我們的問答環節和今天的呼籲到此結束。感謝您參加今天的演講。您現在可以斷開連線。