Journey Medical Corp (DERM) 2024 Q2 法說會逐字稿

Good day, and welcome to Journey Medical second-quarter 2024 financial results and corporate update conference call. (Operator instructions) Participants on 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 this call will be available approximately one hour after the end of the call for approximately 30 days.

美好的一天，歡迎參加征途醫療 2024 年第二季財務表現和公司更新電話會議。（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，並且也被錄製以供回放之用。本次電話會議的網路直播重播將在電話會議結束後約一小時內進行，持續約 30 天。

I would like to turn the conference over to Ms. Jaclyn Jaffe, the company's Senior Director of Corporate Operations. Please go ahead, ma'am.

我想將會議轉交給該公司企業營運資深總監 Jaclyn Jaffe 女士。請繼續，女士。

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.

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 Journey Medical's most recently filed periodic reports on Form 10-K and Form 10-Q and 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 Journey Medical 最近向 SEC 提交的表格 10-K 和表格 10-Q 以及表格 8-K 定期報告中描述的風險因素以及隨附的公司新聞稿這一呼籲，特別是其中的警告性聲明。

Today's conference call includes non-GAAP financial measures that Journey Medical's 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, the 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 GAAP 財務指標與淨虧損（最直接可比較的 GAAP 財務指標）的調整表，請參閱公司收益新聞稿中的調整表。

The content of this call contains time-sensitive information that is accurate only as of today, Monday, August 12, 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 8 月 12 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。

Thank you, Jaclyn, and good afternoon to everyone on the call today. I am pleased to report on the ongoing progress that we are making at Journey Medical. Our second-quarter results were solid with $14.9 million in net product revenue. We believe that our second-quarter performance demonstrates that we remain on track to meet our 2024 annual revenue guidance range of $55 million to $60 million.

謝謝你，賈克琳，祝今天參加電話會議的每個人下午好。我很高興地報告我們 Journey Medical 正在取得的進展。我們第二季的業績表現穩健，淨產品收入為 1,490 萬美元。我們相信，第二季的業績顯示我們仍有望實現 2024 年 5,500 萬美元至 6,000 萬美元的年度收入指導範圍。

We also believe that our second-quarter results highlight the strength of our base business as we await the November 4, producer date for DFD-29, our product candidate for rosacea. With our core portfolio of prescription dermatology brands, generating operating cash in our direct commercial organization already calling on physicians that generate greater than 90% of prescriptions written in our dermatology network, we believe we are well prepared to leverage the DFD-29 opportunity.

我們也相信，在我們等待 11 月 4 日 DFD-29（我們的紅斑痤瘡候選產品）的生產日期之際，我們的第二季度業績凸顯了我們基礎業務的實力。憑藉我們的核心處方皮膚科品牌組合，在我們的直接商業組織中產生運營現金，已經呼籲醫生在我們的皮膚科網絡中生成超過90% 的處方，我們相信我們已做好充分準備，利用DFD- 29 機會。

Looking at the TRXs for our top brands, Qbrexza grew by approximately 4,000 prescriptions when compared to Q2 of 2023, and Accutane grew by 17,000 prescriptions during the same period. Qbrexza and Accutane together contributed $12.6 million in net product revenue for Q2 this year. Additionally, we are pleased to report that both to 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 groups.

從我們頂級品牌的 TRX 來看，與 2023 年第二季相比，Qbrexza 的處方數量增加了約 4,000 個，Accutane 同期的處方數量增加了 17,000 個。今年第二季度，Qbrexza 和 Accutane 合計貢獻了 1,260 萬美元的產品淨收入。此外，我們很高興地報告，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。

In particular, our reach has expanded with both prescriber adoption of our brands and the expansion of our pharmacy network. Looking at the quarterly performance of our four core commercial brands to Qbrexza, Accutane, Amzeeq and Zilxi. succeed during this quarter, these products accounted for more than 90% of our revenue. Importantly, we generated a positive contribution from our core product portfolio with the support of our optimized commercial infrastructure.

特別是，隨著處方者採用我們的品牌和我們藥房網路的擴展，我們的影響力不斷擴大。看看我們的四個核心商業品牌 Qbrexza、Accutane、Amzeeq 和 Zilxi 的季度業績。在本季度取得成功後，這些產品占我們收入的 90% 以上。重要的是，在優化的商業基礎設施的支持下，我們的核心產品組合做出了積極貢獻。

Simply put, the revenues generated from these products have surpassed our operating expenses, excluding one-time prelaunch expenses for DFD-29 such as the NDA filing fee of $4.1 million and the recent milestone payment that we made to Dr. Reddy's of $3 million for NDA acceptance. In addition to our solid top line results, we delivered non-GAAP adjusted EBITDA of $300,000 in the second-quarter. I am very pleased to report that this is the fourth consecutive quarter that we achieved positive adjusted EBITDA results.

簡而言之，這些產品產生的收入已經超過了我們的營運支出，不包括DFD-29 的一次性上市前費用，例如410 萬美元的NDA 申請費以及我們最近向Reddy 博士支付的300 萬美元的里程碑付款。除了穩健的營收業績外，我們第二季的非 GAAP 調整後 EBITDA 為 300,000 美元。我很高興地向大家報告，這是我們連續第四個季度實現調整後 EBITDA 的正值。

Our strategic initiative to significantly reduce SG&A expenses, including the rationalization of our sales and marketing headcount, has been a key factor in improving our profitability while maintaining our product revenue base from 2023. Since the beginning of 2023, when this initiative began, we have reduced our total expenses by approximately $22 million, enabling us to contain our costs and retain more cash generated from our sales. Importantly, our financial discipline puts us in a strong position to leverage the anticipated launch of DFD-29 with the goal to become sustainably cash flow positive in the coming quarters and EBITDA positive in 2025.

我們大幅減少 SG&A 費用（包括銷售和行銷人員數量的合理化）的策略性舉措，是提高獲利能力、同時從 2023 年起維持產品收入基礎的關鍵因素。自 2023 年初該計劃開始以來，我們已將總費用減少了約 2,200 萬美元，使我們能夠控製成本並保留更多銷售產生的現金。重要的是，我們的財務紀律使我們處於有利地位，可以利用 DFD-29 的預期推出，目標是在未來幾個季度實現可持續的正現金流，並在 2025 年實現正 EBITDA。

Given that we remain focused in our two main objectives for the year. First, achieving our financial guidance and continuing to improve our profitability. And second, preparing for the anticipated approval and launch of DFD-29, with approximately 16.5 million people suffering from rosacea and more than 4 million prescriptions filled in the United States alone each year to treat this condition.

鑑於我們仍然專注於今年的兩個主要目標。第一，實現財務指引，持續提升獲利能力。其次，為 DFD-29 的預期批准和上市做準備，僅在美國每年就有大約 1650 萬人患有紅斑痤瘡，並且有超過 400 萬張處方用於治療這種疾病。

We believe that DFD-29 provides a significant growth opportunity for the company. As many of you recall, the clinical trial results for both our Phase 3 DFD-29 studies were very positive and clinically compelling. On both co-primary endpoints, IGA success and reduction of inflammatory lesions associated with rosacea.

我們相信 DFD-29 為公司提供了重要的成長機會。正如你們許多人所記得的那樣，我們的 3 期 DFD-29 研究的臨床試驗結果非常積極且具有臨床說服力。在兩個共同主要終點上，IGA 成功以及與紅斑性痤瘡相關的發炎病變減少。

DFD-29 demonstrated statistical superiority to both Placebo and Oracea current standard of care and market-leading oral treatment for rosacea. We believe that the head-to-head superiority demonstrated in our Phase 3 clinical trials will carry significant weight with prescribers and health plans as we initially position DFD-29 against store ratio, which had over $300 million in annual TRX sales in 2023.

DFD-29 在統計學上優於安慰劑和 Oracea 目前的紅斑痤瘡護理標準和市場領先的口服治療。我們相信，我們的3 期臨床試驗中所展示的頭對頭優勢將對處方者和健康計劃產生重大影響，因為我們最初將DFD-29 與Store Ratio 進行對比，該公司2023 年TRX 年銷售額超過3億美元。

Additionally, in our Phase three trials, DFD-29 demonstrated the ability to significantly reduce erythema or skin redness associated with rosacea. We believe this is meaningful clinical results from our Phase 3 program that can differentiate DFD-29 product profile if approved, and can help accelerate both prescriber and patient adoption. The market for Rosacea treatments in the United States for both oral and topical products is approximately $1.2 billion annually. With the anticipated indication of erythema and DFD-29 label, we believe DFD-29 will be positioned to take share of the broader realization treatment market.

此外，在我們的第三階段試驗中，DFD-29 證明能夠顯著減少與紅斑痤瘡相關的紅斑或皮膚發紅。我們相信，這是我們 3 期計劃的有意義的臨床結果，如果獲得批准，可以區分 DFD-29 產品概況，並有助於加速處方者和患者的採用。在美國，紅斑性痤瘡治療的口服和外用產品市場每年約為 12 億美元。憑藉預期的紅斑適應症和 DFD-29 標籤，我們相信 DFD-29 將佔據更廣泛的實現治療市場份額。

Our Phase 3 results also demonstrated a favorable safety and tolerability profile for DFD-29, with results that were similar to placebo. This gives us high confidence in the DFD-29 clinical and regulatory package, as well as the potential for market approval later this year.

我們的 3 期結果也證明了 DFD-29 具有良好的安全性和耐受性，結果與安慰劑相似。這讓我們對 DFD-29 臨床和監管方案以及今年稍後獲得市場批准的潛力充滿信心。

As you may recall, earlier this year, we conducted market research in which we surveyed prescribers of authorization treatments and leading commercial insurance plans to assess the adoption potential of DFD-29. The feedback was very positive for both sets of participants given the statistical significant Phase 3 results against Placebo and and ratio as well as the positive erythema results.

您可能還記得，今年早些時候，我們進行了市場調查，調查了授權治療的處方者和領先的商業保險計劃，以評估 DFD-29 的採用潛力。鑑於相對於安慰劑和比率的統計顯著性第三階段結果以及陽性紅斑結果，兩組參與者的回饋都是非常正面的。

Health care prescribers expressed a strong willingness to prescribe DFD-29 for their rosacea patients with an adoption rate of 79%. This was a compelling result which exceeded our own internal expectations. For our survey of payers, which collectively represented over 200 million covered lives the interviews showed that most, if not all, PBMs, GPOs and other managed care organizations are likely to contract with us to provide coverage for DFD-29. We believe that this market research demonstrates that DFD-29 will have high acceptance among prescribers and the negotiations with payers for formulary inclusion and reimbursement, it will be favorable assuming DFD-29 is approved.

醫療保健處方者表示強烈願意為紅斑痤瘡患者開立 DFD-29，採用率達 79%。這是一個令人信服的結果，超出了我們內部的預期。我們對總共代表超過 2 億受保人的付款人進行的調查顯示，大多數（如果不是全部）PBM、GPO 和其他管理式醫療組織可能會與我們簽訂合同，提供 DFD-29 的承保。我們相信，這項市場研究表明 DFD-29 將在處方者中獲得較高的接受度，並且與付款人就處方納入和報銷進行談判，如果 DFD-29 獲得批准，這將是有利的。

A key component of our value creation strategy has been to focus on building a portfolio of specialty dermatology products with strong intellectual property. As a result of our patent litigation settlements in 2022 and 2023, we have a strong runway of patent exclusivity for Qbrexza with current patent exclusivity to 2030 Amzeeq with current patent exclusivity to 2031 and Zilxi with current patent exclusivity to 2027.

我們價值創造策略的關鍵組成部分是專注於建立具有強大智慧財產權的專業皮膚科產品組合。由於我們在2022 年和2023 年達成專利訴訟和解，我們擁有強大的專利獨佔權，包括Qbrexza 的當前專利獨佔權至2030 年、Amzeeq 的當前專利獨佔權至2031 年以及Zilxi 的當前專利獨佔權至2027年。

Importantly, DFD-29 will also add to our portfolio providing exclusivity until 2039. As a result, we anticipate having market exclusivity without generic intrusion for the foreseeable future. With our focus on the prescription dermatology segment, we have a strong presence and track record in the business development community for dermatology products.

重要的是，DFD-29 也將添加到我們的產品組合中，並在 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性，而不會受到一般藥物的入侵。由於我們專注於處方皮膚科領域，我們在皮膚科產品的業務開發社群中擁有強大的影響力和良好的記錄。

As a result, we have a robust effort for evaluating 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, similar to the Maruho transaction for the rights to Qbrexza in certain Asian countries.

因此，我們大力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智慧財產權和相關技術授權給美國以外有興趣且有能力的公司，類似於 Maruho 在某些亞洲國家獲得 Qbrexza 權利的交易。

This out-licensing transaction resulted in $19 million of nondilutive capital to the company last year. We will continue to explore to monetize our IP and technologies globally for Qbrexza, Amzeeq and Zilxi as well as DFD-29 in the future.

去年，這項對外許可交易為公司帶來了 1,900 萬美元的非稀釋資本。未來，我們將繼續探索在全球範圍內將 Qbrexza、Amzeeq 和 Zilxi 以及 DFD-29 的智慧財產權和技術貨幣化。

Additionally, we will continue to survey the dermatology landscape for revenue-generating product opportunities that we can acquire or in-license to leverage our focused commercial infrastructure. And we will also continue to evaluate late-stage product candidates that have demonstrated strong clinical trial results in dermatology indications and where we can satisfy unmet market needs for our physician customers and their patients.

此外，我們將繼續調查皮膚病學領域，尋找我們可以獲得或獲得許可以利用我們專注的商業基礎設施的創收產品機會。我們還將繼續評估在皮膚科適應症方面表現出強大臨床試驗結果的後期候選產品，以及我們可以滿足醫生客戶及其患者未滿足的市場需求的產品。

We believe that executing on one or more of these product opportunities would allow us to bring in additional revenue with minimal investments adding to both our top and bottom line. And with that, I will now turn the call over to our CFO, Joe Benesch, to review our financial results for the second-quarter.

我們相信，執行其中一個或多個產品機會將使我們能夠以最少的投資帶來額外的收入，從而增加我們的收入和利潤。現在，我將把電話轉給我們的財務長 Joe Benesch，以審查我們第二季的財務業績。

Thank you, Claude, and good afternoon to everyone on the call. Our net product revenue for the second quarter of 2024 with $14.9 million compared to $17 million for the second-quarter of 2023. The decrease from the prior year period was primarily due to the timing of customer orders due to Qbrexza, continued generic competition for target docs and our decision to discontinue the middle at the end of the third quarter of 2023. Keep in mind, we started 2023 with 70 sales territories, doctor or adjustments. We began 2024 with 35 sales territories.

謝謝你，克勞德，祝所有參加電話會議的人下午好。我們 2024 年第二季的產品淨收入為 1,490 萬美元，而 2023 年第二季為 1,700 萬美元。與去年同期相比下降的主要原因是 Qbrexza 導致客戶訂單的時間安排、目標文件的通用競爭持續以及我們決定在 2023 年第三季末停止中間業務。請記住，2023 年伊始，我們有 70 個銷售區域、醫生或調整。2024 年伊始，我們的銷售地區達到了 35 個。

Sequentially net product revenue for the second-quarter increased by $1.8 million compared to the first quarter of 2024, driven by higher volume for Qbrexza and continued growth of Accutane. These results suggest that we remain on track to meet or exceed our revenue guidance for the year.

受 Qbrexza 銷量增加和 Accutane 持續成長的推動，第二季產品淨收入較 2024 年第一季增加了 180 萬美元。這些結果表明我們仍有望達到或超過我們今年的收入指引。

Our gross profit margin increased slightly from the prior year quarter driven primarily by product mix and the contractual royalty decrease due to Qbrexza that occurred in May of 2023.

我們的毛利率較上年同期略有增加，這主要是由於產品組合以及 2023 年 5 月發生的 Qbrexza 導致的合約特許權使用費減少所致。

R&D. expense decreased by $900,000 from the prior year quarter Due to lower DFD-29 clinical trial expenses as the clinical phase of the project has concluded.

研發。費用較去年同期減少 90 萬美元，原因是隨著計畫臨床階段的結束，DFD-29 臨床試驗費用降低。

Looking now to our SG&A expenses, SG&A decreased by $1.8 million or 15% from the prior year quarter, as a result of our continued expense management efforts decrease in addition to the $4.7 million reduction in SG&A expenses that were reported in Q1 of this year and the $15.6 million reduction that we realized in 2023.

現在看看我們的 SG&A 費用，SG&A 比去年同期減少了 180 萬美元，即 15%，這是由於我們持續的費用管理努力減少，加上今年第一季報告的 SG&A 費用減少了 470 萬美元，我們在2023 年實現了1560 萬美元的削減。

Continuing now to our GAAP net loss for the periods. GAAP net loss to common shareholders was $3.4 million, or $0.17 per share, basic and diluted for the second-quarter of 2024. This compares to a GAAP net loss to common shareholders of $8.4 million or $0.46 per share basic and diluted for the second-quarter of 2023.

現在繼續我們的公認會計原則淨虧損。2024 年第二季基本和稀釋後的 GAAP 普通股股東淨虧損為 340 萬美元，即每股 0.17 美元。相較之下，2023 年第二季普通股股東的 GAAP 淨虧損為 840 萬美元，或每股基本虧損和攤薄虧損 0.46 美元。

Turning now to our non-GAAP results. Our non-GAAP adjusted EBITDA for the second-quarter of 2024 resulted in income of $300,000, reflecting our fourth consecutive quarter of positive non-GAAP adjusted EBITDA, this compares to a non-GAAP adjusted EBITDA loss $6 million for the second-quarter of 2023. We ended the second-quarter of 2024 with $23.9 million in cash compared to $24.1 million at March 31, 2024.

現在轉向我們的非公認會計準則績效。我們2024 年第二季的非GAAP 調整後EBITDA 營收為300,000 美元，反映出我們連續第四個季度實現非GAAP 調整後EBITDA 正值，相較之下，2024 年第二季非GAAP 調整後EBITDA 虧損600 萬美元。截至 2024 年第二季末，我們的現金為 2,390 萬美元，而截至 2024 年 3 月 31 日，我們的現金為 2,410 萬美元。

Our cash balance includes the $3 million milestone payment that we made to Dr. Reddy's upon the FDA's acceptance of our DFD-29 NDA application as well as the $5 million drawdown on our SWK credit facility, both of which took place in the second-quarter.

我們的現金餘額包括在FDA 接受我們的DFD-29 NDA 申請後我們向Dr. Reddy's 支付的300 萬美元里程碑付款，以及我們在SWK 信貸額度中提取的500 萬美元，這兩項都發生在第二季度。

Lastly, we are on track to meet and potentially exceed the financial guidance that we communicated at year end, which is to achieve net product 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，即實現產品淨收入在 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，研發費用在900萬至1000萬美元之間。

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

非常感謝。現在我將把電話轉回給克勞德。

Thank you, Joe. The second-quarter results demonstrate the strength of our base business as we delivered revenue results on track with our annual guidance range and generated our fourth consecutive quarter of positive non-GAAP adjusted EBITDA. We've strengthened the IP position around our core dermatology portfolio established a productive business development platform and right sized our operations, positioning us well strategically and financially in advance of an anticipated DFD-29 launch, which has transformative potential for our business.

謝謝你，喬。第二季的業績證明了我們基礎業務的實力，我們的營收業績符合我們的年度指引範圍，並連續第四個季度實現了非 GAAP 調整後 EBITDA 的正值。我們圍繞著核心皮膚科產品組合加強了知識產權地位，建立了高效的業務發展平台，並調整了我們的營運規模，在預期的DFD-29 上市之前在戰略和財務上為我們做好了定位，這對我們的業務具有變革潛力。

Thank you, operator. We are now ready to open the lines for Q&A.

謝謝你，接線生。我們現在已準備好開放問答線路。

(Operator instructions)

（操作員說明）

Kalpit Patel, B. Riley Securities.

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

Yes, hey, good afternoon and thanks for taking the questions. Maybe one for, one related to DFD-29 looks like for Asia, there was a generic entry a little sooner than we had anticipated, and it looks like there's a launch in April May timeframe. So I have a question for you is, does that in any sense impact your internal forward estimates for DFD-29 launch?

是的，嘿，下午好，感謝您提出問題。也許一個與 DFD-29 相關的一個看起來像亞洲，有一個通用條目比我們預期的要早一點，而且看起來像是在 4 月 5 月的時間範圍內發布。所以我有一個問題要問你，這是否會影響你對 DFD-29 發射的內部前瞻性預測？

Yes, Hi, Kelly. This is Claude. So yes, Lupin came out in April of this year on they have a very similar, if not identical price to the Oracea AG that's out there. And in terms of our moving forward and negotiations with the payers, we do not see this as a critical factor and any headwinds.

是的，嗨，凱利。這是克勞德.所以，是的，Lupin 於今年 4 月推出，因為它們的價格與 Oracea AG 的價格非常相似，甚至完全相同。就我們的前進以及與付款人的談判而言，我們不認為這是一個關鍵因素和任何阻力。

Okay. And then assuming you guys get FDA approval here in November, what early metrics would you recommend investors to focus on in the first few quarters of launch? That might be useful.

好的。然後假設你們在 11 月獲得 FDA 批准，您會建議投資者在發布的前幾季關注哪些早期指標？這可能有用。

Well, sure. Just to sort of take one step back, we're anticipating an approval on November 4, our producer date. At that time we're anticipating having product delivered and hopefully into our 3PL for product distribution. We are targeting sometime in late Q1 for that to take place. If anything helps us from a label printing. It could put us into April, but we are counting towards March right now.

嗯，當然。退一步來說，我們預計 11 月 4 日（即我們的生產日期）獲得批准。屆時，我們預計產品已交付，並希望進入我們的 3PL 進行產品分銷。我們的目標是在第一季末的某個時間實現這一目標。如果標籤列印對我們有幫助的話。它可能會讓我們進入四月，但我們現在正在指望三月。

So we'll get distribution moving in March, and then the sales and marketing team will execute on the pull through with the product beginning in Q2. Some of the metrics I would certainly look for if I was an investor is after the first full month is just where our prescriptions landed and what sort of volume that we've created there. So one would be prescriptions.

因此，我們將在三月開始分銷，然後銷售和行銷團隊將從第二季開始執行產品的拉動工作。如果我是投資者，我肯定會在第一個完整月之後尋找一些指標，這些指標就是我們的處方到達的地方以及我們在那裡創造的交易量。所以其中之一就是處方。

I think another metric that one should follow is to see the uptick in physician adoption. So how many unique prescribers begin to prescribe DFD-29 and the market share that we start to share in the field with Oracea and the other generic that you just mentioned. I think those are three basic areas, but I would look to early on in a launch.

我認為人們應該遵循的另一個指標是看到醫生採用率的上升。那麼有多少獨特的處方者開始開立 DFD-29 處方，以及我們開始與 Oracea 和您剛才提到的其他仿製藥在該領域分享的市場份額。我認為這是三個基本領域，但我會在發布初期就關注這一點。

Okay. Got it. And how should we think about the SG&A ramp for fiscal year 2025? And as a follow-up, do you expect to give forward guidance maybe starting next year when you're launch phase?

好的。知道了。我們該如何看待 2025 財年的 SG&A 成長？作為後續行動，您是否期望從明年啟動階段開始提供前瞻性指導？

Sure. Yes, we have been preparing for DFD and the marketing and everything that comes along with executing a flawless launch early next year in the first half of next year. So in terms of marketing spend SG&A spend, I think, you know, for pre approval, you're seeing a few million dollars already put into play here in 2025.

當然。是的，我們一直在為 DFD 和行銷以及明年初、明年上半年完美發布所帶來的一切做準備。因此，就行銷支出、SG&A 支出而言，我認為，為了預先批准，您會看到 2025 年已經投入了數百萬美元。

We'll certainly meet that and exceed that to execute our launch for DFD. In terms of the forecast that we will give, as we get closer to the launch next year. We'll plan on giving some sort of guidance as we have done this year in 2024. I just think it's a bit early, right now for us to comment on that Kalpit.

我們一定會滿足並超越這個目標來執行我們的 DFD 發布。就我們將給出的預測而言，隨著我們距離明年的推出越來越近。我們將計劃在 2024 年提供某種指導，就像我們今年所做的那樣。我只是認為現在對卡爾皮特發表評論還為時過早。

Okay. Makes sense. Thank you very much for taking the questions.

好的。有道理。非常感謝您接受提問。

Sure.

當然。

Scott Henry, Alliance Global Partners.

史考特亨利，聯盟全球合作夥伴。

Thank you and good afternoon. Couple of questions. For starters, gross margins as expected picked up in 2Q relative to first quarter, would you expect a continued increase in gross margins in the third-quarter and fourth-quarter of the year?

謝謝你，下午好。有幾個問題。首先，第二季的毛利率較第一季有所回升，您是否預計今年三季和第四季的毛利率會持續成長？

Joe, would you like to take?

喬，你願意帶嗎？

Sure, Scott. Our margins definitely will continue to grow, right now, we're at the lowest level of royalty for for Qbrexza. A lot of the one-time expenses are behind us. So you'll definitely see more growth in the margins going forward.

當然，斯科特。我們的利潤肯定會繼續成長，目前，我們處於 Qbrexza 的最低特許權使用費水準。很多一次性費用已經過去了。因此，您肯定會看到未來利潤率有更多成長。

Okay and then on SG&A, it looks like about $8.4 million in first-quarter, $10.3 million in second-quarter and which one of those numbers do you think is more reflective of what we should expect going forward?

好的，然後在 SG&A 方面，第一季約為 840 萬美元，第二季約為 1,030 萬美元，您認為其中哪個數字更能反映我們對未來的預期？

Scott, I think you're going to see you're right in between probably in the $9 million mark in Q2 and are in line with our guidance and expectations for the total SG&A line for the year.

史考特，我想你會發現第二季你的收入可能在 900 萬美元之間，並且符合我們對今年 SG&A 總額的指導和預期。

Okay, great. And then with regards to DFD-29, the erythema, the data, they're strong and you want to get it in the label. When we think about that in the label, should we think about the data being in the label? Or could this potentially be a claim within the indications?

好的，太好了。然後關於 DFD-29，紅斑，數據，它們很強烈，你想把它寫在標籤上。當我們在標籤中考慮這一點時，我們是否應該考慮標籤中的資料？或者這可能是適應症範圍內的聲明？

Yes, Dr. Sidgiddi, would you like to take that one, please?

是的，Sidgiddi 博士，您想拿走那個嗎？

Sure Claude. Thank you. Hey Scott. So the erythema, we have two things over there, one is the claim the indication itself, which would be and it might in addition to inflammatory lesions, we also have data that we have in the proposed PI and we expect data for erythema to be there in the label as well.

當然是克勞德。謝謝。嘿斯科特。所以紅斑，我們有兩件事，一是聲稱適應症本身，這可能是除了發炎性病變之外，我們還有建議的 PI 中的數據，我們預期紅斑的數據是標籤上也有。

Okay, great. Thank you for that color. And final question, Amzeeq, Zilxi, was there how did they perform relative to the first-quarter? Was there some growth there?

好的，太好了。謝謝你的那個顏色。最後一個問題，Amzeeq、Zilxi，他們相對於第一季的表現如何？那裡有一些增長嗎？

Yes, Scott, there was some growth there with both of the brands combined. Absolutely.

是的，斯科特，這兩個品牌的合併帶來了一些成長。絕對地。

Okay. And I guess even though that was supposed to be the last question. I guess Accutane, we'll see the numbers when I look at the filing, but it sounds like that was a new record quarter for revenues there. Is that an accurate statement?

好的。我想即使這應該是最後一個問題。我想Accutane，當我查看文件時我們會看到這些數字，但聽起來那是該季度收入的新紀錄。這是一個準確的說法嗎？

Yeah, I think that probably Joe can give more specific split you'll see revenue for Q2 with that Accutane match up being relatively equal to what you saw in Q1 of this year, so maybe a little bit higher.

是的，我認為喬可能可以給出更具體的分配，您會看到第二季的收入與 Accutane 的收入相對等於您今年第一季看到的收入，所以可能會高一點。

Okay. Thank you for taking the questions.

好的。感謝您提出問題。

Jason Wittes, Roth.

傑森·維茨，羅斯。

Hi, thank you taking questions. On DFD-29 the center expertise of external pull you took of purchasers and reimbursers. What does it what kind of confidence that give you out of the gate in terms of where you might be with reimbursement and the purchasers and in terms of how many years that you think it might take to get full penetration of the DFD-29 opportunity?

你好，謝謝你提出問題。在 DFD-29 上，您吸收了購買者和報銷者的外部拉力的中心專業知識。什麼樣的信心可以讓您在報銷和購買者方面以及您認為可能需要多少年才能充分利用 DFD-29 機會方面走出大門？

Yes, sure, Jason. First of all, the survey that we took was a third party independent from us looked at about 220 million lives in total. We feel like a benchmark for us to really go out there and shoot for could be close to that 200 million lives in coverage.

是的，當然，傑森。首先，我們進行的調查是獨立於我們的第三方，總共調查了約 2.2 億人的生活。我們覺得這是我們真正走出去並爭取接近覆蓋 2 億人生命的基準。

So that's really what we're going to strive for once we get approval and once negotiations begin in terms of the uptake and when we would expect to have that full lives in terms of our coverage on that could take anywhere from 6 months to 12 months, perhaps a little bit longer, but that's pretty much the guidance we're giving here.

因此，一旦我們獲得批准，一旦我們就採用情況開始談判，並且我們預計我們的覆蓋範圍可能需要 6 個月到 12 個月不等，這就是我們真正要努力的目標。就是我們在這裡給出的指導。

Okay. That's very helpful. And then in terms of, maybe a question about this before. But in terms of SG&A and specifically sales force build, it sounds like roughly $9 million is the right SG&A number for this year. My understanding was there might be a little bit of growth in that next year with the launch of DFD-29, specifically, you may add additional salespeople. Is that the right way to think about it or sort of this rate kind of the rate we should anticipate even going into next year?

好的。這非常有幫助。然後就而言，也許之前有過一個關於這個的問題。但就 SG&A，特別是銷售團隊建設而言，聽起來大約 900 萬美元是今年正確的 SG&A 數字。我的理解是，隨著 DFD-29 的推出，明年可能會有一點成長，具體來說，您可能會增加更多的銷售人員。這是思考這個問題的正確方式嗎？

Yeah. In terms of looking at the sales force, I think we're in a really solid place with our platform as is if I give you a few points here, 92% of all voracious prescriptions come from dermatology, and that's over 300,000 prescriptions in a year. When we look at those physicians and profile them, we have 90% of those prescribers have been writing Journey Medical products are already.

是的。就銷售團隊而言，我認為我們的平台處於非常穩固的地位，就好像我在這裡給你幾點意見一樣，所有貪婪的處方中92% 來自皮膚科，而這在一個醫學領域有超過300,000 個處方。當我們查看這些醫生並對他們進行分析時，我們發現其中 90% 的處方者已經在編寫 Journey Medical 產品。

So we are calling on the right people. And then 93% of the coverage has written specifically or ratio page prescriptions as well. So with our current 35 sales configuration, I think you're going to see us stay at the same amount moving into launch, depending on our hockey stick ramp up and what our needs are, we will continue to analyze and see if we want to fill other territories that make sense, but we're going to wait and launch with this current configuration.

所以我們正在召集合適的人。然後93%的報告也寫了具體的或比率的頁面處方。因此，根據我們目前的35 種銷售配置，我認為您將看到我們在推出時保持相同的數量，具體取決於我們的曲棍球棒的增長和我們的需求是什麼，我們將繼續分析並看看我們是否想要填補其他有意義的領域，但我們將等待並使用當前配置啟動。

So from a headcount, I think you'll see very minimal. If anything, you'll see perhaps maybe five sales additions towards the end of 2025. If that and then in 2026 we'll reassess. In terms of our marketing spend for its part in SG&A. I think we're well set with what we have already configured. So Joe, I'll give you the mic over here on SG&A for anything else you wanted to add on it.

因此，從人數來看，我認為您會看到的人數非常少。如果有的話，到 2025 年底，您可能會看到銷量增加 5 倍。如果是這樣，我們將在 2026 年重新評估。就我們在 SG&A 中的行銷支出而言。我認為我們已經配置好了。喬，我會將 SG&A 上的麥克風交給您，以便您可以添加任何其他內容。

Sure. Thanks, Claude. So to answer your question now that you're not going to see a huge ramp up in SG&A from year over year, going to be pretty consistent. You will see some marketing expenses come through. We will see some inflationary cost increase, but you're not going to see anything enormous come through any kind of big swings.

當然。謝謝，克勞德。所以現在回答你的問題，你不會看到SG&A逐年大幅成長，而是相當一致的。您會看到一些行銷費用的產生。我們會看到通貨膨脹成本增加，但你不會看到任何巨大的波動。

Great. Thank you for the clarifications and answers here. I'll jump back in queue.

偉大的。感謝您在這裡的澄清和回答。我會插回隊列。

This concludes our question-and-answer session, as well as our conference call for today. Thank you for attending today's presentation.

我們的問答環節以及今天的電話會議到此結束。感謝您參加今天的演講。