Journey Medical Corp (DERM) 2024 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to Journey Medical's first quarter 2024 financial results and corporate update conference call. (Operator Instructions) A webcast replay of the call will be available approximately one hour after the end of the call for approximately 30 days.

女士們先生們，謝謝你們的支持。下午好，歡迎參加旅程醫療 2024 年第一季財務表現及公司更新電話會議。（操作員說明）電話會議的網路廣播重播將在電話會議結束後約一小時內提供，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. Jaclyn, please go ahead.

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

Good afternoon and thank you for participating in today's conference call. Joining me from Journey Medical's leadership team are Claude Maraoui, Co-Founder, President and Chief Executive Officer; Joseph Benesch, 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 領導團隊的還有共同創辦人、總裁兼執行長 Claude Maraoui；約瑟夫‧貝內施 (Joseph Benesch)，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 to 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.

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 10-K 表格和 10-Q 表格定期報告、今天向 SEC 提交的 8-K 表格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, Monday, May 13, 2024. 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訊息，僅截至今天（2024 年 5 月 13 日星期一）準確。除法律要求外，Journey Medical 不承擔公開更新或修改任何資訊以反映本次電話會議後發生的事件或情況的義務。

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, Jaclyn, and good afternoon to everyone on the call today. I am pleased to report on the progress that we've made at Journey Medical. I will begin with the positive results that we delivered in Q1.

謝謝賈克琳，今天參加電話會議的每個人都下午好。我很高興地報告我們在 Journey Medical 的進展。我將從我們在第一季取得的積極成果開始。

During the period, we generated revenue of $13 million, which is a 7% increase over the first quarter of last year. This growth was driven primarily by strong revenues of Qbrexza and Accutane. These two products together contributed over $10.8 million in revenue in Q1 2024 versus $8.7 million in Q1 2023. This represents year-over-year growth of 24%.

在此期間，我們創造了1,300萬美元的收入，比去年第一季成長了7%。這一成長主要是由 Qbrexza 和 Accutane 的強勁收入推動的。這兩款產品在 2024 年第一季合計貢獻了超過 1,080 萬美元的收入，而 2023 年第一季為 870 萬美元。這意味著同比增長 24%。

Looking at the TRxs, Qbrexza grew by approximately 1,800 prescriptions when compared to Q1 of 2023, and Accutane grew by 29,000 prescriptions when compared to Q1 2023, showing strong progress for both brands. Additionally, both Qbrexza and Accutane gained market share in their respective categories. This was achieved through a combination of efforts by our sales and marketing team and our trade and access group.

從 TRx 來看，與 2023 年第一季相比，Qbrexza 增加了約 1,800 個處方，Accutane 與 2023 年第一季相比增加了 29,000 個處方，這表明兩個品牌都取得了強勁的進步。此外，Qbrexza 和 Accutane 都在各自類別中獲得了市場份額。這是透過我們的銷售和行銷團隊以及貿易和准入團隊的共同努力實現的。

Particularly, our reach has expanded both with prescriber adoption of our brands and the expansion of our pharmacy network. Our expectation is for these brands to continue to grow throughout the remainder of 2024.

特別是，隨著處方者採用我們的品牌和擴大我們的藥房網絡，我們的影響力不斷擴大。我們期望這些品牌在 2024 年剩餘時間內持續成長。

Our strategic pivot has significantly reduced SG&A expenses during 2023 in order to achieve profitability has shown to be a success. This was most recently evidenced by our performance during the first quarter, where we were able to achieve 7% revenue growth and profitability in our base business with only 35 territories versus the 59 territories that we had in Q1 of 2023.

我們的策略重點在 2023 年大幅減少了銷售、管理和行政費用，以實現盈利，這已被證明是成功的。我們第一季的業績證明了這一點，我們的基礎業務僅在 35 個地區就實現了 7% 的收入增長和盈利能力，而 2023 年第一季我們有 59 個地區。

Looking at the performance of our four core commercial brands during the quarter, Qbrexza, Accutane, Amzeeq, and Zilxi make up more than 90% of our revenue. And importantly, these brands generated a positive contribution given our optimized commercial infrastructure. Simply put, the revenues generated from these products have surpassed our SG&A expenses, with the exception of one-time occurrences, such as our NDA filing fee for DFD-29. Historically, Q1 is typically our softest quarter as we are affected by seasonality in our business as well as insurance deductible resets that take place throughout the first quarter of each year.

從本季我們四個核心商業品牌的表現來看，Qbrexza、Accutane、Amzeeq 和 Zilxi 占我們營收的 90% 以上。重要的是，這些品牌為我們優化的商業基礎設施做出了積極貢獻。簡而言之，這些產品產生的收入已經超過了我們的銷售、管理和行政費用（SG&A 費用），但一次性事件除外，例如我們的 DFD-29 的 NDA 申請費。從歷史上看，第一季通常是我們最疲軟的季度，因為我們受到業務季節性以及每年第一季發生的保險免賠額重置的影響。

Looking ahead into 2024, we continue to expect growth from our core brands and further expect to benefit from additional incremental expense reductions as a result of our cost optimization efforts that took place in 2023. We believe that these dynamics position us to achieve sustained profitability on an adjusted EBITDA basis and highlight the potential future leverage of our business, particularly with the anticipated launch of DFD-29. From a macro perspective, our primary emphasis as an organization is to continue preparing for the impending launch of our DFD-29 product candidate. DFD-29 is a novel oral therapy for the treatment of Rosacea, with best-in-class potential. There are approximately 16.5 million patients that suffer from Rosacea in the United States.

展望 2024 年，我們繼續預期我們的核心品牌將實現成長，並進一步預期我們將受益於 2023 年成本優化工作帶來的額外增量費用削減。我們相信，這些動態使我們能夠在調整後的 EBITDA 基礎上實現持續盈利，並凸顯我們業務未來的潛在槓桿作用，特別是在 DFD-29 的預期推出之後。從宏觀角度來看，我們作為一個組織的首要重點是繼續為即將推出的 DFD-29 候選產品做好準備。DFD-29 是一種治療紅斑痤瘡的新型口服療法，具有同類最佳的潛力。在美國約有 1650 萬名患者患有紅斑痤瘡。

In 2023, there were over 4 million total prescriptions written for Rosacea, which is a 5% increase over 2022. We believe that DFD-29 provides a significant growth opportunity for the company as well as for our shareholders. The clinical trial results for both our Phase 3 studies were positive on both of the co-primary endpoints, IGA success, which is investigator global assessment, and the reduction of inflammatory lesions associated with Rosacea.

2023 年，紅斑痤瘡處方總數超過 400 萬張，比 2022 年增加了 5%。我們相信 DFD-29 為公司和我們的股東提供了重要的成長機會。我們兩項 3 期研究的臨床試驗結果在兩個共同主要終點、IGA 成功（研究者的整體評估）以及與紅斑痤瘡相關的發炎病變的減少方面均呈陽性。

DFD-29 demonstrated statistical superiority to both Placebo and Oracea, current standard of care, and market leading oral treatment for Rosacea. To provide color around the DFD-29 market opportunity, Oracea had over $300 million in annual TRx sales in 2023. We believe that based on DFD-29's superior efficacy as demonstrated in our Phase 3 clinical trials, there is a significant opportunity to take market share from Oracea, as well as from other topical treatments that are commonly prescribed to treat Rosacea.

DFD-29 表現出優於安慰劑和 Oracea、目前的護理標準以及市場領先的紅斑痤瘡口服治療藥物的統計優勢。為了圍繞 DFD-29 市場機會提供色彩，Oracea 到 2023 年的 TRx 年銷售額將超過 3 億美元。我們相信，基於 DFD-29 在我們的 3 期臨床試驗中所證明的卓越功效，有很大的機會從 Oracea 以及通常用於治療紅斑痤瘡的其他局部治療藥物中奪取市場份額。

Additionally, DFD-29 demonstrated the ability to significantly reduce Erythema, or the skin redness associated with Rosacea. We believe this is a meaningful clinical result from our Phase 3 clinical trials that can differentiate DFD-29's product profile if approved and can help accelerate both prescriber and patient adoption. The Phase 3 results also demonstrated a favorable safety and tolerability profile for DFD-29, with safety results that were similar to placebo.

此外，DFD-29 還表現出顯著減少紅斑或與酒渣鼻相關的皮膚發紅的能力。我們相信，這是我們 3 期臨床試驗的一個有意義的臨床結果，如果獲得批准，可以區分 DFD-29 的產品概況，並有助於加速處方者和患者的採用。第三階段結果也證明了 DFD-29 具有良好的安全性和耐受性，安全性結果與安慰劑相似。

Based on the full set of clinical trial results, we recently conducted and completed a fresh round of market research, which focused on two critical groups. First was a survey conducted with prescribers of Rosacea treatments to measure the likelihood of adoption of DFD-29. Second was a survey of the payers that represent a majority of commercial insurance plans to measure their willingness to include DFD-29 on their formulary.

基於全套臨床試驗結果，我們最近進行並完成了新一輪的市場研究，重點是兩個關鍵群體。首先是與酒渣鼻治療處方者進行的調查，以衡量採用 DFD-29 的可能性。其次是對代表大多數商業保險計劃的付款人進行的調查，以衡量他們將 DFD-29 納入其處方集的意願。

I am pleased to report that the feedback was positive for both sets of participants. Favorable responses were driven by statistical superiority of DFD-29 when compared head-to-head versus Oracea in reducing inflammatory lesions and IGA success, as well as statistical significant reduction in clinicians' Erythema assessment score of DFD-29 versus placebo.

我很高興地報告，兩組參與者的回饋都是正面的。與 Oracea 相比，DFD-29 在減少發炎病灶和 IGA 成功方面具有統計優勢，以及 DFD-29 與安慰劑相比臨床醫師紅斑評估評分的統計顯著降低，推動了良好的反應。

Healthcare prescribers overwhelmingly confirmed their willingness to adopt and prescribe DFD-29 for the Rosacea patients, and a adoption rate of 79%. In our industry, this is an astoundingly high rate and translates into an approximate 8 out of 10 Rosacea prescriptions going to DFD-29. This rate exceeded even our own internal expectations and gives us the confidence in a successful DFD-29 launch.

絕大多數醫療保健處方者確認願意為紅斑痤瘡患者採用和開立 DFD-29，採用率為 79%。在我們的行業中，這是一個驚人的高比例，大約十分之八的紅斑痤瘡處方會使用 DFD-29。這個速度甚至超出了我們自己的內部預期，讓我們對成功發射 DFD-29 充滿信心。

Given the 16.5 million Rosacea sufferers in the United States and over 4 million prescriptions written annually, the prescriber adoption rate captured in our market research makes us even more excited about DFD's market potential. With respect to the payer market research results, the data shows most, if not almost all PBMs, GPOs, and other managed care organizations are likely to contract with us to provide coverage for DFD-29 for over 200 million lives.

鑑於美國有 1650 萬紅斑痤瘡患者以及每年超過 400 萬張處方，我們的市場研究中獲得的處方者採用率讓我們對 DFD 的市場潛力更加興奮。關於付款人市場研究結果，數據顯示大多數（如果不是幾乎所有）PBM、GPO 和其他管理式醫療組織都可能與我們簽訂合同，為超過 2 億人提供 DFD-29 保險。

As a result of this market research, we are even more confident that DFD-29 will have high acceptance among prescribers and that negotiations with payers for formulary inclusion and reimbursement will be favorable after DFD-29 is approved. We will provide additional details on pre-launch activities later in the year as we finalize the launch plans, pricing, and product positioning for DFD-29.

透過這項市場研究，我們更有信心 DFD-29 將得到處方者的高度認可，並且在 DFD-29 獲得批准後，與付款人就處方納入和報銷進行的談判將是有利的。我們將在今年稍後確定 DFD-29 的發射計劃、定價和產品定位時提供有關發射前活動的更多詳細資訊。

To recap on our regulatory activities in Q1, we submitted our new drug application for DFD-29 on January 4th, and the application was accepted by the FDA on March 13, whereby FDA provided us with key timelines of the review process and a PDUFA date of November 4th of this year. Given the impressive efficacy and safety data generated from the DFD Phase 3 head-to-head clinical trial program, we remain highly confident that FDA will provide us with an approval by the PDUFA date.

回顧第一季的監管活動，我們於 1 月 4 日提交了 DFD-29 新藥申請，該申請於 3 月 13 日被 FDA 接受，FDA 向我們提供了審查過程的關鍵時間表和 PDUFA 日期今年11月4日。鑑於 DFD 第 3 期頭對頭臨床試驗計劃產生的令人印象深刻的療效和安全性數據，我們仍然非常有信心 FDA 將在 PDUFA 日期之前向我們提供批准。

Regarding intellectual property, DFD-29 has a robust patent profile. We currently have three orange book listable patents to provide exclusivity until 2039. As a result, we anticipate having market exclusivity without generic intrusion for the foreseeable future.

在智慧財產權方面，DFD-29 擁有強大的專利概況。目前，我們擁有三項橙皮書列出的專利，可在 2039 年之前提供排他性。因此，我們預計在可預見的未來將擁有市場獨佔權，而不會受到一般性入侵。

To conclude on our discussion of DFD-29, we believe the achievement of superior efficacy and safety results will pave the way for a new Rosacea treatment paradigm, which would significantly enhance the value of our company, as well as the value that we bring to the dermatology prescribers and patients alike.

最後，我們對DFD-29 的討論得出結論，我們相信卓越的療效和安全性結果的實現將為新的紅斑痤瘡治療範例鋪平道路，這將顯著提高我們公司的價值以及我們為客戶帶來的價值皮膚科醫生和病人都一樣。

Moving into our business development efforts, we continue to evaluate opportunities to enhance shareholder value. A primary focus for the company is to continue to out-license our intellectual property and related technologies to interested and capable companies outside of the United States.

在我們的業務發展工作中，我們持續評估提高股東價值的機會。該公司的主要重點是繼續將我們的知識產權和相關技術授權給美國以外感興趣且有能力的公司。

In 2023, we entered into an out-licensing agreement with Maruho, which resulted in a $19 million upfront licensing payment for the rights to develop and commercialize Qbrexza in certain Asian countries. We will continue to explore opportunities to exploit and monetize our IP and technologies globally for Qbrexza, Amzeeq , and Zilxi , as well as DFD-29.

2023 年，我們與 Maruho 簽訂了一項外包授權協議，為 Qbrexza 在某些亞洲國家的開發和商業化權利支付了 1,900 萬美元的預付款授權。我們將繼續探索在全球範圍內為 Qbrexza、Amzeeq 和 Zilxi 以及 DFD-29 利用我們的智慧財產權和技術並實現貨幣化的機會。

Second, we continue to survey the dermatology landscape for new product opportunities that we can acquire or in-license FDA-approved products as well as late-stage product candidates. That would allow us to leverage our focused commercial infrastructure. In this regard, our first priority would be to bring in commercially available FDA-approved prescription dermatology products that would fit directly into our existing commercial footprint.

其次，我們繼續調查皮膚病學領域，尋找我們可以獲得或授權 FDA 批准的產品以及後期候選產品的新產品機會。這將使我們能夠利用我們專注的商業基礎設施。在這方面，我們的首要任務是引入經 FDA 批准的市售處方皮膚科產品，這些產品將直接適合我們現有的商業足跡。

As a secondary focus, we will continue evaluating late-stage product candidates that have demonstrated strong clinical trial results in therapeutic areas in dermatology, where there are unmet treatment needs that we believe we can best serve patients. Executing on one or more of these opportunities would allow us to bring in additive revenue with minimal investment in our infrastructure, adding to both our top and bottom lines.

作為次要重點，我們將繼續評估已在皮膚科治療領域表現出強大臨床試驗結果的後期候選產品，這些領域存在未滿足的治療需求，我們相信我們可以最好地為患者服務。抓住這些機會中的一個或多個將使我們能夠以最少的基礎設施投資帶來額外的收入，從而增加我們的收入和利潤。

And with that, I will now turn the call over to our Chief Financial Officer, Joe Benesch, to review our financial results for the first quarter of 2024.

現在，我將把電話轉給我們的財務長 Joe Benesch，以審查我們 2024 年第一季的財務表現。

Thank you, Claude. Good afternoon to everyone on the call. Our total net revenue for the first quarter of 2024 was $13 million, compared to $12.2 million for the first quarter of 2023. The increase is primarily due to increases in net product revenues for Qbrexza and Accutane, as we continue to focus our marketing efforts on these products.

謝謝你，克勞德。各位來電的人下午好。我們 2024 年第一季的總淨收入為 1,300 萬美元，而 2023 年第一季為 1,220 萬美元。這一成長主要是由於 Qbrexza 和 Accutane 的淨產品收入增加，因為我們繼續將行銷工作重點放在這些產品上。

Our gross profit margin increased slightly year-over-year, driven by higher sales. R&D expense increased by $5.9 million from the prior year quarter, driven by a $4.1 million DFC-29 application fee payment to the FDA in January and the $3 million expense for a contractual milestone payment, triggered by the FDA's acceptance of our DFC-29 application in March. These one-time expenses were offset by lower DFC-29 clinical trial expenses, as the project winds down and eventually concludes.

在銷售額增加的推動下，我們的毛利率較去年同期略有成長。研發費用比去年同期增加了 590 萬美元，因為 1 月份向 FDA 支付了 410 萬美元的 DFC-29 申請費，以及 FDA 接受我們的 DFC-29 申請引發的合約里程碑付款的 300 萬美元費用三月。隨著計畫逐漸結束並最終結束，這些一次性費用被較低的 DFC-29 臨床試驗費用所抵消。

Looking now to our SG&A expenses. SG&A decreased by $4.7 million or 35% from the prior year quarter, as a result of our continued expense management efforts. This is in addition to the $15.6 million reduction in SG&A in 2022 and 2023 that we reported at year end.

現在看看我們的 SG&A 費用。由於我們持續進行費用管理，SG&A 比去年同期減少了 470 萬美元，即 35%。這還不包括我們在年底報告的 2022 年和 2023 年 SG&A 減少 1,560 萬美元的情況。

Continuing to our net loss for the periods. Net loss to common shareholders were $10.4 million or $0.53 per share basic and diluted for the first quarter of 2024 compared to a net loss to common shareholders of $10.1 million or $0.57 per share basic and diluted for the first quarter of 2023. The loss of the period was substantially due to one-time charges for the FDA application fee and the milestone payment discussed previously.

繼續我們的期間淨虧損。2024 年第一季普通股股東淨虧損為1,040 萬美元，即基本虧損和稀釋每股虧損0.53 美元，而2023 年第一季普通股股東淨虧損為1,010 萬美元，即基本虧損和稀釋每股虧損0.57 美元。這段期間的損失主要是由於 FDA 申請費的一次性收費和先前討論的里程碑付款。

Starting now to our non-GAAP results. Our non-GAAP adjusted EBITDA for the first quarter of 2024 resulted in income of positive $11,000, reflecting our third consecutive non-GAAP adjusted EBITDA positive quarter.

現在開始我們的非公認會計準則績效。我們 2024 年第一季的非 GAAP 調整後 EBITDA 營收為正 11,000 美元，反映出我們連續第三個非 GAAP 調整後 EBITDA 為正季。

This compares to a non-GAAP adjusted EBITDA loss of $5.3 million for the first quarter 2023. While the first quarter was only slightly positive, we do expect non-GAAP adjusted EBITDA to increase more significantly throughout the remainder of 2024.

相較之下，2023 年第一季非 GAAP 調整後 EBITDA 虧損為 530 萬美元。雖然第一季僅略有成長，但我們預計非 GAAP 調整後 EBITDA 在 2024 年剩餘時間內將出現更顯著的成長。

We ended the first quarter of 2024 with $24.1 million in cash compared to $27.4 million at December 31, 2023. Cash spent for the quarter reflects our cash outlay for the one-time FDA application fee payment of $4.1 million offset by positive cash flow from operations.

截至 2024 年第一季末，我們的現金為 2,410 萬美元，而 2023 年 12 月 31 日為 2,740 萬美元。本季的現金支出反映了我們支付一次性 FDA 申請費的現金支出 410 萬美元，並被營運產生的正現金流所抵銷。

Lastly, we are on track to meet and potentially exceed the financial guidance that we communicated at year end, which is to achieve net revenues in the range of $55 million to $60 million, SG&A expense in the range of $39 million to $42 million, and R&D expense in the range of $9 million to $10 million.

最後，我們預計將達到並可能超過我們在年底傳達的財務指導，即實現淨收入在 5500 萬美元至 6000 萬美元範圍內，SG&A 費用在 3900 萬美元至 4200 萬美元範圍內，以及研發費用在900萬美元到1000萬美元之間。

Thank you very much. I will now turn the call back over to Claude.

非常感謝。我現在將把電話轉回給克勞德。

Thank you, Joe. The first quarter results demonstrate the strength of our base business as we delivered year-over-year growth and generated our third consecutive quarter of positive non-GAAP adjusted EBITDA.

謝謝你，喬。第一季的業績證明了我們基礎業務的實力，我們實現了同比增長，並連續第三個季度實現了非 GAAP 調整後 EBITDA 的正值。

By strengthening the IP around our portfolio, right-sizing our operating expenses, advancing DFD-29 towards US market approval, and bringing in non-dilutive capital from our business development initiatives, I believe that the company is now stronger than ever, and we are ready for the next growth phase in our journey.

透過加強我們產品組合的智慧財產權、合理調整我們的營運支出、推動DFD-29 獲得美國市場批准，以及從我們的業務發展計劃中引入非稀釋資本，我相信公司現在比以往任何時候都更強大，我們為我們旅程的下一個成長階段做好準備。

Thank you. Operator, we are now ready to open the lines for Q&A.

謝謝。接線員，我們現在準備開通問答線路。

(Operator Instructions) Scott Henry, Alliance Global Partners.

（操作員說明）Scott Henry，Alliance Global Partners。

Thank you, and good afternoon. First, Joe, congratulations on losing the interim title of CFO.

謝謝你，下午好。首先，喬，祝賀您失去財務長的臨時頭銜。

Thanks, Scott.

謝謝，斯科特。

So starting on the numbers, COGS was a little higher relative to Q4. I thought we were going to start to see more consistent numbers there. Was there a reason, or is there a reset in the COGS line that we should still be factoring in?

因此，從數字開始，COGS 相對於第四季度略高。我認為我們將開始看到更一致的數字。是否有我們仍應考慮的原因，或者 COGS 行是否有重置？

Yeah. Thanks, Scott, and thanks for the congrats. I really appreciate it.

是的。謝謝斯科特，也謝謝你的祝賀。對此，我真的非常感激。

Really the margins were a little bit lower due to product mix. That's the first piece. Product mix to the higher margin products was pretty prevalent in the first quarter. And also, we had some isolated freight costs, isolated testing costs, and we had some raw material obsolescence that came through the first quarter. Moving to the second quarter, third quarter, things should go back to normal.

事實上，由於產品組合的原因，利潤率有點低。這是第一塊。第一季度，高利潤產品的產品組合相當普遍。此外，我們還有一些單獨的貨運成本、單獨的測試成本，而且第一季我們還有一些原料過時。進入第二季、第三季度，情況應該會恢復正常。

Okay. And by normal, we should get a 40% or I guess a 60% plus gross margin?

好的。正常情況下，我們應該獲得 40% 或我猜 60% 以上的毛利率？

Exactly, back where we were in the December realm, or the fourth quarter realm.

確切地說，回到我們在十二月領域或第四季領域的位置。

Okay, great. There were also some comments as to Qbrexza and Accutane being the main growth drivers of the current product portfolio. Do you have any thoughts on which one of those two would be the larger growth asset? I would think it would be Qbrexza, but the script numbers were pretty strong for Accutane. Just want to get your sense on that.

好的，太好了。還有一些評論認為 Qbrexza 和 Accutane 是當前產品組合的主要成長動力。您對這兩項資產中哪一項是更大的成長資產有什麼想法嗎？我認為會是 Qbrexza，但 Accutane 的劇本數量相當強勁。只是想了解您對此的感覺。

Sure. Yeah. Hi, Scott. It's Claude. I'll start out.

當然。是的。嗨，斯科特。是克勞德。我就開始吧。

Accutane and Qbrexza are certainly key drivers for us as we continue to move forward. Like you said, approximately 29,000 prescription increase year over year, same quarter. So just tremendous growth there. We had just a little shy of 2,000 prescriptions in growth with Qbrexza.

Accutane 和 Qbrexza 無疑是我們不斷前進的關鍵驅動力。正如您所說，同一季度約 29,000 份處方藥年增。所以那裡有巨大的成長。我們的 Qbrexza 處方數量增加了接近 2,000 個。

So I'll start out with Accutane first since it had the largest demand increase. This ISO treatment known market is growing. We're penetrating more and more into the market share area. We're looking at now close to 17% plus market share. So that's a very good sign.

因此，我將首先從維他命A酸開始，因為它的需求增加最大。這種已知的 ISO 處理市場正在不斷成長。我們正在越來越多地滲透到市場份額領域。我們目前的目標是接近 17% 以上的市場份額。所以這是一個非常好的跡象。

We don't anticipate hitting a ceiling with that. I think if you take a look at our best quarter ever, it was about 75,000, 73,000 prescriptions, and here we are at 93,000. So if you just take a run rate of that, you're still showing strong double-digit growth moving into this year here with Accutane.

我們預計不會達到上限。我想如果你看我們有史以來最好的季度，大約有 75,000 個、73,000 個處方，而這裡我們是 93,000 個。因此，如果您只看運行率，您會發現今年 Accutane 仍呈現強勁的兩位數成長。

With Qbrexza in terms of market share gains, we are -- it is a seasonal drug. The winter is typically a slower time for us in terms of picking up demand. So as we get into the warmer months that we're into right now in this calendar year, our momentum seems to be picking up with that and having stronger demand.

隨著 Qbrexza 市場份額的增長，我們——它是一種季節性藥物。冬季對我們來說通常是需求成長較慢的時期。因此，當我們進入今年的溫暖月份時，我們的勢頭似乎正在增強，需求也更加強勁。

So I think our sales team as well as our marketing promotion is working very effectively. This is all about getting awareness out there with the product as well as just constant education. So most people still don't have the full understanding and that there's a benefit for what they're ailing with.

所以我認為我們的銷售團隊以及我們的行銷推廣工作非常有效。這一切都是為了提高人們對產品的認識以及不斷的教育。所以大多數人仍然沒有完全理解，也不知道這對他們所遇到的問題有好處。

So yeah, more growth. I would tell you that Qbrexza should be in the mid to high single digits as we keep going and could venture into the double digits. So both those will drive our growth.

所以是的，更多的成長。我想告訴你，隨著我們繼續前進，Qbrexza 應該處於中高個位數，並且可能會達到兩位數。因此，這兩者都將推動我們的成長。

Okay, great. Thank you, Claude. And then just shifting over quickly to DFD-29, I heard a lot of great color on the surveys that you have run with clinicians. I mean, should we look for that to be published somewhere or perhaps you'll include some slides in your presentation? I'm just wondering how you're going to disseminate some of that data.

好的，太好了。謝謝你，克勞德。然後快速轉向 DFD-29，我在與臨床醫生進行的調查中聽到了很多精彩的內容。我的意思是，我們是否應該尋找在某個地方發布該內容，或者您​​可能會在簡報中包含一些幻燈片？我只是想知道你們將如何傳播其中一些數據。

Yeah, sure. Scott, we used a third-party independent market research company, Indegene, you probably will know it. And we certainly will have some slides in the very near future included in our deck as we go that will be posted on our website.

好，當然。Scott，我們使用了第三方獨立市場研究公司Indegene，你可能會知道。在不久的將來，我們肯定會在我們的幻燈片中包含一些幻燈片，並將其發佈在我們的網站上。

Okay, great. Well, thank you for taking the questions.

好的，太好了。好的，謝謝您提出問題。

Kalpit Patel, B. Riley Securities.

卡爾皮特‧帕特爾 (Kalpit Patel)，B. 萊利證券 (Riley Securities)。

Yeah. Hey, good afternoon. Thanks for taking the questions. Maybe starting with DFD-29, have you had any initial conversations with peers on the drug's profile? I know you probably need to wait until the drug is approved to have any official contract signed, but just wanted to know if you had any color on preliminary dialogue with peers.

是的。嘿，下午好。感謝您提出問題。也許從 DFD-29 開始，您是否與同行就該藥物的概況進行初步對話？我知道您可能需要等到藥物獲得批准才能簽署正式合同，但只是想知道您在與同行的初步對話中是否有任何意見。

Yeah, absolutely, Kalpit. We certainly have done the market research that was also done recently. So it's fresh and new.

是的，絕對是，卡爾皮特。我們當然已經完成了最近也完成的市場調查。所以它是新鮮的和新的。

We looked at over the payers that included lives of over 220 million covered lives nationally, so a very good broad sample. They looked at the Phase 3 clinical trials. We offered all the various product attributes, the proposition value and overwhelmingly in terms of acceptance and being able to negotiate and get that covered. That way, we have the access and ability to do the pull through with our sales and marketing promotion.

我們調查了支付者，其中包括全國超過 2.2 億人的生命，所以這是一個非常廣泛的樣本。他們研究了第三階段臨床試驗。我們提供了所有不同的產品屬性、主張價值以及壓倒性的接受度、談判能力和覆蓋範圍。這樣，我們就有機會和能力來完成我們的銷售和行銷推廣。

Overwhelming response is very, very positive. We will be able to get good coverage on DFD-29. And as you mentioned, we won't be able to negotiate with payers until after the approval.

壓倒性的反應是非常非常積極的。我們將能夠對 DFD-29 進行良好的覆蓋。正如您所提到的，在獲得批准之前，我們無法與付款人進行談判。

Okay. Got it. All right. And then you previously guided that you would potentially break even, or you've been turned cash flow positive in fiscal year 2024. Can you comment if this guidance is still unchanged as of today?

好的。知道了。好的。然後您之前預測，您可能會實現收支平衡，或在 2024 財年實現正現金流。如果截至今天該指導意見仍然沒有變化，您能發表評論嗎？

Yeah. Joe, would you like to handle that please?

是的。喬，你願意處理嗎？

Sure. So thanks, Kalpit. The guidance is definitely unchanged. Basically, we have some DFD-29 launch costs in our budget. As you pull all those launch costs out, pull some of the non-cash stuff out.

當然。所以謝謝，卡爾皮特。指導方針肯定沒有改變。基本上，我們的預算中有一些 DFD-29 的發射成本。當你去掉所有這些啟動成本時，也去掉一些非現金的東西。

The core business is contribution positive at this time. So we continue to work towards that. And by year end, we believe we're going to be non-GAAP EBITDA positive as we suspected.

此時的核心業務是貢獻正值。因此，我們將繼續為此努力。到年底，我們相信我們將如我們所懷疑的那樣實現非公認會計準則 EBITDA 為正值。

Okay, perfect. Thank you very much.

好的，完美。非常感謝。

Thank you very much. Seeing no further lines in the queue, this concludes our question-and-answer session. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines and have a great day.

非常感謝。看到隊伍中不再有隊伍，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。您現在可以斷開線路並度過美好的一天。