Catalyst Pharmaceuticals Inc (CPRX) 2024 Q1 法說會逐字稿

Greetings, and welcome to the Catalyst Pharmaceuticals first quarter 2024 financial results conference call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. (Operator Instructions)

您好，歡迎您參加 Catalyst Pharmaceuticals 2024 年第一季財務業績電話會議。此時，所有參與者都處於只聽模式。正式演講後將舉行簡短的問答環節。（操作員說明）

As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Kalb, Chief Financial Officer. Thank you, sir. You may begin.

提醒一下，本次會議正在錄製中。現在我很高興向您介紹主持人，財務長邁克·卡爾布。謝謝你，先生。你可以開始了。

Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst first quarter 2024 financial results and business highlights. Richard Daly, President and CEO, will be leading the call today. Jeff Del Carmen, Chief Commercial Officer, and I will also be presenting. Additionally, Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer. We'll be available for the Q&A.

謝謝。大家早安，感謝您參加我們的電話會議，討論 Catalyst 2024 年第一季的財務表現和業務亮點。總裁兼執行長理查德·戴利 (Richard Daly) 將主持今天的電話會議。我和首席商務官 Jeff Del Carmen 也將出席演講。此外，我們的營運長兼首席科學官 Steven Miller 博士。我們將接受問答。

Before we begin, I would like to remind you that in our remarks this morning and in the Q&A session, we will make statements about expected future results, which may be forward-looking statements for purposes of Federal Securities Laws.

在開始之前，我想提醒您，在今天早上的演講和問答環節中，我們將做出有關預期未來結果的聲明，這些聲明可能是聯邦證券法規定的前瞻性聲明。

These statements relate to our current expectations, estimates and projections and are not guarantees of future performance. They involve risks, uncertainties and assumptions that are difficult to predict and may not prove to be accurate.

這些陳述涉及我們目前的預期、估計和預測，並非對未來績效的保證。它們涉及難以預測且可能不準確的風險、不確定性和假設。

As actual results may vary from the expectations contained in our forward-looking statements. These forward-looking statements should be considered only in conjunction with the detailed information contained in our SEC filings, including the risk factors described in our 2023 Annual Report on Form 10-K filed with the SEC on February 28, 2024, and in our first quarter 2024 quarterly report on Form 10-Q, which was filed yesterday with the SEC. At this time, I'll turn the call over to Rich

由於實際結果可能與我們前瞻性陳述中包含的預期有所不同。這些前瞻性陳述僅應與我們向SEC 提交的文件中包含的詳細資訊結合考慮，包括我們於2024 年2 月28 日向SEC 提交的2023 年年度報告10-K 表格中描述的風險因素，以及我們在第一份報告中所述的風險因素。這時候我會把電話轉給Rich

Welcome to the Catalyst Q1 2024 fourth-quarter results call. Today, we will discuss our excellent performance in the first quarter as well as our continued focus on execution, provide an update on clinical and regulatory milestones delve into our portfolio diversification approach, and finally provide insight into our continued delivery on financial discipline.

歡迎參加 Catalyst 2024 年第一季第四季業績電話會議。今天，我們將討論我們在第一季度的出色表現以及我們對執行的持續關注，提供臨床和監管里程碑的最新信息，深入研究我們的投資組合多元化方法，最後深入了解我們在財務紀律方面的持續交付。

In Q1 2024, we delivered another quarter of strong performance with total revenues of $98.5 million. This performance, along with our January equity raise, enhanced our substantial cash position, which totaled $310.4 million as of March 31, 2024.

2024 年第一季度，我們又一個季度表現強勁，總營收達到 9,850 萬美元。這項業績，加上我們 1 月的股權融資，增強了我們大量的現金頭寸，截至 2024 年 3 月 31 日，現金頭寸總計 3.104 億美元。

During the quarter, our agility and focus on execution enabled our team to respond to opportunities in the market and drive continued growth in FIRDAPSE, successfully launch AGAMREE and deliver on consistent performance for FYCOMPA.

在本季度，我們的敏捷性和對執行的專注使我們的團隊能夠應對市場機會並推動 FIRDAPSE 的持續成長，成功推出 AGAMREE 並為 FYCOMPA 提供一致的業績。

I want to congratulate our team for continuing to meet the challenging targets we set for them. We are poised for promising growth as demonstrated by the significant milestones achieved, FYCOMPA continues to deliver strong double digit growth, a tremendous testament to our ability to drive the sustained success of the brand for more than five years.

我要祝賀我們的團隊繼續實現我們為他們設定的具有挑戰性的目標。正如所實現的重要里程碑所證明的那樣，我們已做好了充滿希望的增長準備，FYCOMPA 繼續實現強勁的兩位數增長，這有力地證明了我們有能力推動該品牌在五年多的時間裡持續取得成功。

Additionally, we successfully launched AGAMREE for Duchenne's muscular dystrophy or DMD on March 13. At just over two weeks of launch performance are included in our Q1 financials we are very excited by AGAMREE performance and potential when reviewing AGAMREE uptake trends.

此外，我們於 3 月 13 日成功推出了用於治療杜氏肌肉營養不良症 (DMD) 的 AGAMREE。我們第一季的財務數據中包含了兩週多的發布業績，在回顧 AGAMREE 的採用趨勢時，我們對 AGAMREE 的表現和潛力感到非常興奮。

Based on physician and patient response, we are experiencing a great deal of momentum, and this speaks to the tremendous market conditioning we did prior to the launch as well as our ability to successfully integrate AGAMREE into our Catalyst Pathways, patient services infrastructure.

根據醫生和患者的反應，我們正在經歷巨大的動力，這說明了我們在推出之前所做的巨大市場調節，以及我們將 AGAMREE 成功整合到我們的 Catalyst Pathways、患者服務基礎設施中的能力。

Although it's early in the launch we believe AGAMREE is positioned for a significant step-up in Q2 and beyond. Jeff will provide further details about product performance during his discussion.

儘管現在還處於發布初期，但我們相信 AGAMREE 已做好準備，將在第二季及以後取得重大進展。Jeff 將在討論中提供有關產品性能的更多詳細資訊。

Let's transition to product development and regulatory. For AGAMREE , we are preparing to launch our previously reported long-term registry study of AGAMREE , which we have rebranded as the SUMMIT study. This study aims to gather long-term patient safety and quality of life data offering a deeper understanding of the product's potential long term benefits for patients.

讓我們轉向產品開發和監管。對於 AGAMREE ，我們正準備啟動先前報告的 AGAMREE 長期註冊研究，我們已將其重新命名為 SUMMIT 研究。這項研究旨在收集長期患者安全和生活品質數據，以便更深入地了解該產品對患者的潛在長期益處。

We recognize that a fundamental challenge in the traditional steroid use in treating DMD is in the safety impact for the long term use of these steroids. Long-term effects can cause doctors and patients to number one, delay initiation of steroids. Number two, dose to load accrued the therapeutic benefits of steroids and number three discontinue steroid use too early.

我們認識到，使用傳統類固醇治療 DMD 的一個根本挑戰是長期使用這些類固醇的安全性影響。長期影響可能會導致醫生和患者的第一個反應是延遲開始使用類固醇。第二，劑量負荷會產生類固醇的治療效果，第三，過早停止使用類固醇。

We have initiated the SUMMIT study designed in accordance with FDA guidance for the use of real-world data to evaluate the long-term safety and quality of life benefits of The AGAMREE. AGAMREE may offer patients and physicians the opportunity to start therapy sooner, optimize the effective dose and stay on therapy longer. With the goal of potentially improving the care of patients with DMD.

我們已經啟動了根據 FDA 指南設計的 SUMMIT 研究，使用真實世界數據來評估 AGAMREE 的長期安全性和生活品質益處。AGAMREE 可以為患者和醫生提供更快開始治療、優化有效劑量並延長治療時間的機會。目標是潛在地改善 DMD 患者的照護。

Moving on to FIRDAPSE, we are eagerly awaiting the June 4, 2024 for PDUFA date of our supplemental new drug application seeking to increase the FIRDAPSE maximum daily dose from 80 milligrams to 100 milligrams. If our SNDA is approved, we believe that it creates the potential to provide increased therapeutic flexibility for patients and the physicians who treat them.

接下來是 FIRDAPSE，我們熱切等待 2024 年 6 月 4 日我們補充新藥申請的 PDUFA 日期，尋求將 FIRDAPSE 每日最大劑量從 80 毫克增加到 100 毫克。如果我們的 SNDA 獲得批准，我們相信它有可能為患者和治療他們的醫生提供更高的治療靈活性。

Internationally. We continue to work with our partner in Japan, DyDo pharma, as they await word from Japanese regulatory authorities on the FIRDAPSE Japan NDA that they filed late last year and with a decision expected around the end of Q3 beginning of Q4 this year.

國際上。我們繼續與我們在日本的合作夥伴 DyDo pharma 合作，他們正在等待日本監管機構就去年年底提交的 FIRDAPSE Japan NDA 發出的消息，預計將於今年第三季末第四季度初左右做出決定。

Next regarding business development and portfolio diversification. We are working on three fronts to increase our BD opportunities. First, expanding our portfolio. We are aggressively exploring opportunities to expand our portfolio in this orphan CNS and orphan adjacent spaces. We are taking a comprehensive approach to approach this decision-making, ensuring alignment with our overarching strategy for optimal success and our long-term vision.

接下來是關於業務發展和投資組合多元化。我們正在三個方面努力增加我們的業務發展機會。首先，擴大我們的投資組合。我們正在積極探索機會，擴大我們在這個孤兒中樞神經系統和孤兒鄰近空間的投資組合。我們正在採取全面的方法來進行這項決策，確保與我們實現最佳成功的整體策略和我們的長期願景保持一致。

Second, we are working to expand our partnerships. We are actively pursuing opportunities to expand the partnerships for FIRDAPSE in the APAC region beyond Japan and looking for to enter agreements in Lat-Am, There is a recognized need for lens treatment options like Firdapse in both regions.

其次，我們正在努力擴大我們的合作關係。我們正在積極尋找機會擴大 FIRDAPSE 在日本以外的亞太地區的合作夥伴關係，並尋求在拉丁美洲簽訂協議。

Additionally, we are pursuing partnerships for AGAMREE with ex-US partners in North America. Third, we are exploring opportunities to diversify and expand the use of our existing products through lifecycle management. Our teams are fully immersed in developing in a guaranteed lifecycle plan seeking to open up new avenues for growth for this product and we expect to provide an update on this project during the second half of this year.

此外，我們正在尋求與北美的前美國合作夥伴建立 AGAMREE 合作夥伴關係。第三，我們正在探索透過生命週期管理實現現有產品多樣化和擴大用途的機會。我們的團隊完全沉浸在有保障的生命週期計劃中，尋求為該產品開闢新的成長途徑，我們預計在今年下半年提供該專案的最新資訊。

Our accomplishments in the first quarter reflect our strong performance with steady product revenue contributions and a promising product launch, further adding to our financial strength and driving our growth. We are grateful to our team for delivering excellent results this quarter, which gives us further confidence as we reaffirm our full year 2024 total revenue guidance in the range of $455 million to $475 million.

我們第一季的成就反映了我們的強勁業績、穩定的產品收入貢獻和充滿希望的產品發布，進一步增強了我們的財務實力並推動了我們的成長。我們感謝我們的團隊在本季度取得了出色的業績，這讓我們在重申 2024 年全年總收入指導值在 4.55 億美元至 4.75 億美元之間時更加充滿信心。

Mike will provide additional details on our financial performance during his discussion today. Since the outset of 2024, we have surge forward with formidable momentum, laying down solid groundwork to drive short and long-term value. We remain excited about the journey ahead.

麥克將在今天的討論中提供有關我們財務業績的更多詳細資訊。2024年伊始，我們以強勁的勢頭奮勇向前，為驅動短期和長期價值奠定了堅實的基礎。我們對未來的旅程仍然感到興奮。

I'll now turn over the call to Jeff Del Carmen, who will provide an overview of our commercial performance.

我現在將把電話轉給 Jeff Del Carmen，他將概述我們的商業表現。

Jeff?

傑夫？

Thanks, Rich, and good morning, everyone. Fueled by the successful execution of our strategic growth initiatives across our entire commercial portfolio. We are exceedingly pleased with our first quarter 2024 performance. As Rich mentioned, Catalyst had an excellent start to 2024, driven by the combination of sustained organic growth of FIRDAPSE , stable revenues from by FYCOMPA in the strong initial commercial launch of AGAMREE’s.

謝謝里奇，大家早安。在我們整個商業投資組合中成功執行策略成長計畫的推動下。我們對 2024 年第一季的業績非常滿意。正如 Rich 所提到的，在 FIRDAPSE 持續有機成長、FYCOMPA 穩定收入以及 AGAMREE 首次商業推出的強勁推動下，Catalyst 在 2024 年取得了良好的開局。

Q1 total net product revenues of $98.4 million, positions Catalyst well to achieve our 2024 full year total revenue guidance. First, let me start with FIRDAPSE. Q1 2024 net sales were $66.8 million, representing a 16% increase over the same quarter last year. In line with our forecasted growth projections, a direct result of a sustained cadence of new patient starts, high compliance and consistent low discontinuation rates.

第一季產品淨收入總額為 9,840 萬美元，使 Catalyst 能夠很好地實現我們的 2024 年全年總收入指引。首先，讓我從 FIRDAPSE 開始。2024 年第一季淨銷售額為 6,680 萬美元，較去年同期成長 16%。與我們預測的成長預測一致，這是新患者開始持續的節奏、高依從性和持續的低停藥率的直接結果。

Net new patients in Q1 2024 were the highest total since Q1 2022. We believe that these facts demonstrate that our underlying FIRDAPSE business is solid. Prescription approval rates are greater than 90% across all payers, government or private commercial insurers.

2024 年第一季的淨新患者總數是 2022 年第一季以來的最高水準。我們相信這些事實表明我們的 FIRDAPSE 基礎業務是穩固的。所有付款人、政府或私人商業保險公司的處方批准率均超過 90%。

As expected net product revenues in the first quarter reflected the typical Q1 seasonality in the reset of deductibles and co-pays at the beginning of the year. In addition, some new patient and refill prescription adjudications were temporarily impacted by the Change Healthcare cyber attack, particularly in February.

正如預期的那樣，第一季的淨產品收入反映了年初重置免賠額和共付額中典型的第一季季節性。此外，一些新患者和補充處方裁決暫時受到 Change Healthcare 網路攻擊的影響，特別是在 2 月。

Given the intensely symptomatic nature of LEMS, we exercised catalyst no patient left behind approach and provided five days of free drug to any FIRDAPSE patient who could not fill their prescription. It is our mission to ensure continuity of care for the patients we serve, and we believe that what we did supports that commitment. I am also glad to report that at the end of the day, we subsequently received reimbursement for all the five day bridge prescriptions provided.

鑑於 LEMS 的嚴重症狀性質，我們採取了「催化劑不讓患者掉隊」的方法，並向任何無法配藥的 FIRDAPSE 患者提供五天的免費藥物。我們的使命是確保為我們服務的患者提供持續的護理，我們相信我們所做的一切都支持了這項承諾。我還很高興地報告，最終，我們隨後收到了所提供的所有五天過渡處方的報銷。

FIRDAPSE refill rate was temporarily affected in February, but we saw a rapid rebound in filled prescriptions in March back to historic norms. Our strategic growth initiatives will continue to drive organic growth moving forward, we maintain a pipeline of approximately 500 lenders patients in various stages of their diagnostic journey that are not yet on FIRDAPSE.

2 月 FIRDAPSE 續配率暫時受到影響，但我們看到 3 月的配藥量迅速反彈，回到歷史正常水平。我們的策略性成長計畫將繼續推動有機成長，我們維持著大約 500 名處於診斷旅程不同階段但尚未加入 FIRDAPSE 的貸方患者的管道。

Tracking these LEMS patients and up is a prime reason for our ability to consistently deliver 15% to 20% annual growth as half our new patient enrollments typically come from this group. Furthermore, LEMS education programs targeting health care providers have already resulted in consistently higher voltage gave the calcium channel antibody testing rates, which will shorten the diagnostic journey for lens patients and lead to more patients being eligible for treatment with FIRDAPSE.

追蹤這些 LEMS 患者及以上患者是我們能夠持續實現 15% 至 20% 年增長率的主要原因，因為我們的新入組患者有一半通常來自這一群體。此外，針對醫療保健提供者的 LEMS 教育計劃已導致鈣通道抗體檢測率持續升高，這將縮短晶狀體患者的診斷旅程，並使更多患者有資格接受 FIRDAPSE 治療。

Now let me provide an update on FYCOMPA . We achieved solid Q1 net revenues of $30.4 million, further fortifying our revenue diversification. We expect continued stable net revenues for the rest of 2024. Further, all epilepsy regional account managers have been trained on FIRDAPSE and LEMS. And moving forward, these ramps will conduct secondary calls with health care providers that account for the 45% overlap in five FYCOMPA and FIRDAPSE physician call points, further increasing FIRDAPSE as share of voice in the ability to identify new LEMS patients.

現在讓我提供 FYCOMPA 的最新情況。第一季我們實現了 3,040 萬美元的穩健淨收入，進一步加強了我們的收入多元化。我們預計 2024 年剩餘時間淨收入將持續穩定。此外，所有癲癇區域客戶經理都接受過 FIRDAPSE 和 LEMS 訓練。展望未來，這些坡道將與醫療保健提供者進行二次呼叫，這些呼叫佔五個 FYCOMPA 和 FIRDAPSE 醫生呼叫點重疊的 45%，進一步提高 FIRDAPSE 在識別新 LEMS 患者的能力方面的話語權份額。

Let's turn to a AGAMREE. We successfully commercially launched again, Marie on March 13. Early indicators of new patient enrollments show strong interest, exceeding initial expectations. This is primarily due to penetration of both the Emflaza and the prednisone patient segments. Payer approval rates are greater than 90%, averaging less than 30 days to approval based on our experience with FIRDAPSE.

讓我們轉向 AGAMREE。我們於 3 月 13 日再次成功商業推出 Marie。新患者入組的早期指標顯示出濃厚的興趣，超出了最初的預期。這主要是由於 Emflaza 和潑尼松患者部位的滲透。根據我們在 FIRDAPSE 方面的經驗，付款人批准率超過 90%，平均批准時間不到 30 天。

We expect this to improve over time. Further to date, 63% of the DMD centers of excellence have enrolled at least one patient on AGAMREE since most of the prescriptions for DMD patients are written by doctors who practice in these centers of excellence. We believe this is a very positive sign for the acceptance of again, right.

我們預計這種情況會隨著時間的推移而改善。迄今為止，63% 的 DMD 卓越中心已在 AGAMREE 上招募了至少一名患者，因為大多數 DMD 患者的處方都是由在這些卓越中心執業的醫生開出的。我們相信，這是一個非常積極的信號，可以再次接受，對吧。

In summary, we believe that we are making meaningful progress on sustained organic growth for FIRDAPSE, continuing to generate stable net revenues for FYCOMPA and exceeding our expectations for our revenues for AGAMREE .

總之，我們相信我們在 FIRDAPSE 的持續有機成長方面正在取得有意義的進展，繼續為 FYCOMPA 創造穩定的淨收入，並超越我們對 AGAMREE 收入的預期。

We are highly focused on continued commercial execution excellence and leveraging our strategies to maximize our demonstrated capabilities. I want to thank the entire team at catalyst for their unwavering commitment to patients and look forward to continuing with a successful 2024.

我們高度關注持續卓越的商業執行，並利用我們的策略來最大限度地發揮我們所展示的能力。我要感謝 Catalyst 的整個團隊對患者堅定不移的承諾，並期待在 2024 年繼續取得成功。

I will now turn the call back over to Mike.

我現在將把電話轉回給麥克。

Thank you, Jeff. As Rich noted, our performance during the first quarter of 2024 has set us on pace for another strong year, driven by our solid financial performance, financial discipline and strong execution. We remain steadfast in our commitment to driving growth, leveraging strategic partnerships and expanding our portfolio to capitalize on emerging opportunities throughout the year.

謝謝你，傑夫。正如 Rich 指出的那樣，在我們穩健的財務業績、財務紀律和強有力的執行力的推動下，我們 2024 年第一季的業績使我們有望再創強勁的一年。我們仍然堅定地致力於推動成長、利用策略合作夥伴關係並擴大我們的產品組合，以利用全年的新機會。

We intend to continue our commitment to growth through strategic partnerships and portfolio expansion in 2024 to support this objective in January 2024 Catalyst sold 10 million shares of its authorized, but on issued common stock to raise net proceeds of approximately $140.7 million for the purposes of funding potential future acquisitions. And for general corporate purposes.

我們打算在2024 年繼續致力於透過策略合作夥伴關係和投資組合擴張來實現成長，以支持這一目標。籌集了約1.407 億美元的淨收益，用於融資目的未來潛在的收購。並用於一般企業目的。

Our total revenues for the first quarter of 2024 were $98.5 million, an approximate 15% increase when compared to total revenues of $85.4 million for the first quarter of 2023. Product revenue net for our lead product, FIRDAPSE were $66.8 million, a 16% increase year-over-year compared to $57.5 million in Q1 2023.

我們 2024 年第一季的總營收為 9,850 萬美元，與 2023 年第一季的總營收 8,540 萬美元相比成長了約 15%。我們的主導產品 FIRDAPSE 的產品淨收入為 6,680 萬美元，與 2023 年第一季的 5,750 萬美元相比，年增 16%。

Product revenue net for the first quarter of 2024 FYCOMPA increased to $30.4 million compared to $27.8 million for the portion of the first quarter of 2023 in which we recognized revenue following our acquisition of the product rights in late January of 2023.

FYCOMPA 2024 年第一季的產品淨收入增至 3,040 萬美元，而 2023 年第一季的產品收入為 2,780 萬美元，我們在 2023 年 1 月下旬收購產品權利後確認了收入。

As a reminder, we anticipate that 2024 revenue for FYCOMPA will be affected by differences in variable consideration compared to 2023 when revenues were booked under sized cost arrangements with distributors and government agencies effective January 1, of this year. These costs are tied to arrangements between the Company and those distributors and agencies which are higher.

提醒一下，我們預計FYCOMPA 2024 年的收入將受到與2023 年相比可變對價差異的影響，2023 年收入是根據與分銷商和政府機構的大規模成本安排入賬的，自今年1 月1 日起生效。這些成本與公司與較高的經銷商和代理商之間的安排有關。

Finally, we launched gamma in mid-March and for the short time during the first quarter that the product was commercially available product revenue that was $1.2 million. In the first quarter of the calendar year. Like many companies in our industry we are impacted by the reset of patient insurance deductibles. Further, in the first quarter of 2024, we reported expenses related to our annual commitment to make charitable contributions to foundations that fund LEMS patient support programs throughout the year.

最後，我們在 3 月中旬推出了 gamma，並在第一季的短時間內，該產品實現了商業化，產品收入為 120 萬美元。在日曆年的第一季。與我們行業的許多公司一樣，我們受到患者保險免賠額重置的影響。此外，在 2024 年第一季度，我們報告了與我們年度承諾向全年資助 LEMS 患者支持計劃的基金會進行慈善捐款相關的費用。

Cost of sales was approximately $12.5 million in the first quarter of 2024 compared to $9.9 million in the first quarter of 2023 and consisted principally of royalties. As a reminder, royalties for FIRDAPSE increased by 3% when net product sales exceed $100 million in any calendar year.

2024 年第一季的銷售成本約為 1,250 萬美元，而 2023 年第一季的銷售成本為 990 萬美元，主要包括特許權使用費。提醒一下，當任何日曆年產品淨銷售額超過 1 億美元時，FIRDAPSE 的特許權使用費就會增加 3%。

As a result, we expect cost of sales to trend higher as this year progresses. Additionally, I would like to note that again, we also carries a royalty in the range of low double digits to mid-20%, depending on sales achievements within a calendar year. Further details on our royalty obligations for AGAMREE are reported in our Q1 2024 form 10-Q.

因此，我們預計隨著今年的進展，銷售成本將呈現上升趨勢。此外，我想再次指出，我們還收取低兩位數到中 20% 範圍內的特許權使用費，具體取決於日曆年內的銷售業績。有關我們對 AGAMREE 的特許權使用費義務的更多詳細信息，請參閱我們的 2024 年第一季度 10-Q 表格。

Research and development expense was $2.6 million in the first quarter of 2024, slightly down from $3.6 million in the first quarter of 2023. At this point, as noted in the 2024 guidance we provided earlier this year, we believe that R&D expense for 2024 will be similar to 2022.

2024 年第一季的研發費用為 260 萬美元，略低於 2023 年第一季的 360 萬美元。目前，正如我們在今年稍早提供的 2024 年指導中指出的那樣，我們認為 2024 年的研發費用將與 2022 年類似。

SG&A expenses for the first quarter of 2024 totaled $46.9 million compared to $29.7 million in Q1 2023. As SG&A expenses moderately increased as a percentage of total operating expenses to 66% for Q1 2024 compared to 60% for Q1 2023.

2024 年第一季的銷售管理及行政費用總計 4,690 萬美元，而 2023 年第一季為 2,970 萬美元。2024 年第一季度，SG&A 費用佔總營運費用的比例略有上升，達到 66%，而 2023 年第一季為 60%。

The overall difference in SG&A expenses in the first quarter of 2024 was principally due to the incremental selling and marketing expenses to support the launch of The AGAMREE and operating expenses for five comp of being present for a full quarter in Q1 2024 when compared to approximately two thirds of Q1 2023,

2024 年第一季SG&A 費用的整體差異主要是由於支持The AGAMREE 推出的增量銷售和行銷費用以及2024 年第一季整個季度存在的五家公司的營運費用（相比之下，大約有兩家公司） 2023 年第一季的三分之一，

As well as the non-cash stock-based compensation charges of $3.9 million relating to the retirement of the company's former CEO and CFO. Based on the terms of their respective separation agreements with the company,

以及與公司前執行長和財務長退休相關的 390 萬美元非現金股票補償費用。根據他們各自與公司簽訂的離職協議的條款，

Our effective tax rate for the first quarter of 2024 was 20% compared to 20.8% for the first quarter of 2023. Although lower in the first quarter of 2024. We still expect our annualized effective tax rate to be slightly higher than the annual effective tax rate in full year 2023 of 24.4%.

我們 2024 年第一季的有效稅率為 20%，而 2023 年第一季的有效稅率為 20.8%。儘管 2024 年第一季較低。我們仍預期年化有效稅率將略高於 2023 年全年的年有效稅率 24.4%。

For 2024 the difference to the statutory federal income tax rate of 21%. This driven primarily was primarily driven by the state by state income taxes and anticipated annual permanent differences. Effective tax rate is affected by many factors, including the number of stock options exercised in any given period and is likely to fluctuate in future periods.

2024 年，與法定聯邦所得稅稅率的差異為 21%。這主要是由州所得稅和預期的年度永久性差異所推動的。有效稅率受到許多因素的影響，包括在任何特定時期內行使的股票選擇權數量，並且在未來期間可能會發生波動。

Net income before income taxes for the first quarter of 2024 was $29.1 million, a 22% decrease year-over-year compared to $37.3 million for the first quarter of 2023. We reported GAAP net income for the first quarter of 2024 of $23.3 million or $0.2 per basic and $0.19 per diluted share, a decrease of 21% year-over-year compared to GAAP net income for the first quarter of 2023 of $29.6 million, or $0.28 per basic and $0.26 per diluted share.

2024 年第一季所得稅前淨利為 2,910 萬美元，較 2023 年第一季的 3,730 萬美元年減 22%。我們公佈的2024 年第一季GAAP 淨利為2,330 萬美元，即每股基本收益0.2 美元，每股稀釋收益0.19 美元，與2023 年第一季GAAP 淨利潤2,960 萬美元相比，年減21% ，或每股基本股 0.28 美元，每股稀釋股 0.26 美元。

The decrease in both net income before income taxes and GAAP net income reflects a full quarter of operating expenses pertaining to FYCOMPA as well as substantial incremental operating expenses to prepare for the launch of AGAMREE. It also includes one time non-cash stock-based compensation expense that I mentioned earlier.

所得稅前淨利潤和 GAAP 淨利潤的下降反映了與 FYCOMPA 相關的整個季度的營運支出以及為準備推出 AGAMREE 而增加的大量營運支出。它還包括我之前提到的一次性非現金股票補償費用。

Non-GAAP net income for the first quarter of 2024 was $46.8 million, or $0.4 per basic and $0.38 per diluted share, which excludes from GAAP net income, amortization of intangible assets related to our acquisitions of FYCOMPA, AGAMREE and reserved fee of $9.3 million, stock-based compensation expense of $8.2 million, income tax provision of $5.8 million and depreciation of $86,000.

2024 年第一季的非GAAP 淨利為4,680 萬美元，即每股基本收益0.4 美元，稀釋每股0.38 美元，其中不包括GAAP 淨利潤、與我們收購FYCOMPA、AGAMREE 相關的無形資產攤銷以及930萬美元的保留費用，股票補償費用為 820 萬美元，所得稅撥備為 580 萬美元，折舊為 86,000 美元。

This compares to non-GAAP net income in the first quarter of 2023 of $46.8 million, or $0.44 per basic and $0.41 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FYCOMPA and resurgence of $6.5 million, stock-based compensation expense of $2.9 million. The income tax provision of $7.7 million and depreciation of $69,000.

相較之下，2023 年第一季的非GAAP 淨利為4,680 萬美元，即每股基本收益0.44 美元，稀釋每股0.41 美元，其中不包括與我們收購FYCOMPA 和中興相關的GAAP 無形資產攤銷650 萬美元，股票補償費用為 290 萬美元。所得稅準備金為 770 萬美元，折舊為 69,000 美元。

As previously reported, we ended the first quarter of 2024 with cash and cash equivalents of $310.4 million compared to $137.6 million at December 31, 2023. The increase in cash of $172.8 million was largely driven by our January 2024 capital raise, which added approximately $140.7 million in net cash proceeds. The remaining increase in cash is driven primarily by $31.9 million in cash generated from business operations.

正如先前報導的那樣，截至 2024 年第一季度，我們的現金和現金等價物為 3.104 億美元，而截至 2023 年 12 月 31 日為 1.376 億美元。現金增加 1.728 億美元，主要是因為我們 2024 年 1 月的融資，增加了約 1.407 億美元的淨現金收益。其餘現金成長主要由業務營運產生的 3,190 萬美元現金推動。

We believe our current funds continue to allow us the financial flexibility to fund our existing R&D programs, meet our potential contractual obligations and support our strategic initiatives, business development and portfolio expansion efforts, leading to long-term growth and value creation.

我們相信，我們現有的資金將繼續為我們提供財務靈活性，為我們現有的研發項目提供資金，履行我們潛在的合約義務，並支持我們的策略舉措、業務發展和投資組合擴張工作，從而實現長期成長和價值創造。

More detailed information and analysis of our first quarter 2024 financial performance may be found in our quarterly report on Form 10-Q, which was filed with the Securities and Exchange Commission yesterday, May 8 and can be found in our Investor Relations page on our website at www.catalystpharma.com.

有關我們2024 年第一季財務業績的更多詳細資訊和分析，請參閱我們於5 月8 日向美國證券交易委員會提交的10-Q 表格季度報告，也可在我們網站上的投資者關係頁面中找到網址：www.catalystpharma.com。

And with that, I will turn the call back over to Rick.

然後，我會將電話轉回給里克。

Thanks, Mike. And Catalyst our mission is resolute to pioneer first-in-class innovative medicines for patients with rare and difficult-to-treat diseases with an expanding portfolio of commercial products and a track record of operational excellence. We are prime for ongoing success in delivering transformative therapies to the market. We look forward to providing updates on our continued progress at this time.

謝謝，麥克。Catalyst 的使命是堅決透過不斷擴大的商業產品組合和卓越營運記錄，為罕見和難治性疾病患者開發一流的創新藥物。我們在向市場提供變革性療法方面取得了持續成功。我們期待此時提供有關我們持續進展的最新資訊。

I'll turn the call back over to the operator, and we look forward to answering your questions. Thank you.

我會將電話轉回給接線員，我們期待回答您的問題。謝謝。

Thank you. We will now be conducting a question and answer session.(Operator Instructions)

謝謝。我們現在將進行問答環節。

Joon Lee, Truist Securities. .

李俊，Truist 證券公司。。

Hi, this is Jeremy on for Joon. Thanks for taking our questions. Can you just share any specific doc or patient feedback on the garmenting experience? And then any further updates on your BD plan telephonic far along? Are you in that search and is there a specific therapeutic area you're targeting such as epilepsy?

大家好，我是 Joon 的 Jeremy。感謝您回答我們的問題。能分享一下醫生或病人對服裝體驗的具體回饋嗎？那麼您的 BD 計劃是否有進一步的電話更新？您是否正在進行該搜尋？

Thanks for the question. Jeff, do you want to handle first part?

謝謝你的提問。傑夫，你想處理第一部分嗎？

It's a little early to come to get some specific feedback about physicians and the efficacy that their patients are seeing with the AGAMREE, what we can tell you is the physicians and the patients are extremely happy with the process to get on off AGAMREE and to get a drug. So that's first and foremost on, but we do anticipate feedback about their patients here shortly.

現在獲得有關醫生及其患者使用 AGAMREE 所看到的療效的一些具體反饋還為時過早，我們可以告訴您的是，醫生和患者對脫離 AGAMREE 並獲得治療的過程非常滿意一種藥物。所以這是首要的，但我們確實預計很快就會收到有關他們的患者的回饋。

And as a second part of the question. So we are aggressively pursuing opportunities, as we mentioned on the call in the orphan space and what we call the orphan adjacent. So we believe our infrastructure is one that really supports patient care. So when you think about what we did in the quarter and really making sure that our patients had on an uninterrupted care.

作為問題的第二部分。因此，我們正在積極尋求機會，正如我們在孤兒空間和我們所說的孤兒相鄰的電話會議中提到的那樣。因此，我們相信我們的基礎設施能夠真正支持患者護理。因此，當您考慮我們在本季所做的事情並真正確保我們的患者獲得不間斷的護理時。

I think it really speaks to the strategic advantage we have as a company. So we believe that our infrastructure supports them essentially any orphan opportunity. And so we are out aggressively seeking opportunities across the orphan space. We believe what we're seeing our success, our continued success, our ongoing success with FIRDAPSE and our burgeoning success with the AGAMREE really supports that.

我認為這確實說明了我們作為一家公司所擁有的策略優勢。因此，我們相信我們的基礎設施基本上支持他們的任何孤兒機會。因此，我們正在孤兒藥領域積極尋找機會。我們相信，我們所看到的成功、持續的成功、FIRDAPSE 的持續成功以及 AGAMREE 的快速成功確實支持了這一點。

So we are looking pretty far and wide on the or in the orphan space. So we're I would say we're pretty essentially agnostic because we believe that our infrastructure would support just about any orphan opportunity.

因此，我們對孤兒空間進行了非常廣泛的研究。所以我想說我們基本上是不可知論的，因為我們相信我們的基礎設施將支持幾乎任何孤兒機會。

Charles Duncan, Cantor Fitzgerald.

查爾斯鄧肯，坎托菲茨杰拉德。

Hey, good morning team. Thanks for taking the question and congratulations on a nice quarter.

嘿，早上好，團隊。感謝您提出問題，並祝賀您度過了一個愉快的季度。

Start the year. I had a couple of them, one on AGAMREE, one on FIRDAPSE and then one BD. So on a AGAMREE, you mentioned new patient enrollment. Very good to hear. Can you give us some color on where you're taking patients from? Is it more Emflaza or is it more prednisone? And any color on that as well as the pacing of information from the new SUMMIT study?

開始新的一年。我有幾張，一張在 AGAMREE，一張在 FIRDAPSE，然後是一張 BD。在 AGAMREE 上，您提到了新患者入組。很高興聽到。您能給我們一些關於您從哪裡接收患者的資訊嗎？是 Emflaza 更多還是潑尼松更多？新的 SUMMIT 研究中的資訊以及資訊節奏有什麼不同嗎？

Great. Charles, great. Thanks for the questions. And not.

偉大的。查爾斯，太棒了。感謝您的提問。並不是。

Jeff, do you want to handle the first part of the question, and we'll have Steve handle the second part.

傑夫，你想解決問題的第一部分嗎？

Good morning, Charles. When we look at enrollments that we're getting so far for AGAMREE, 47% of our new enrollments are from patients that were currently on Emflaza, 43% of our patients were coming from patients that were on prednisone and there are just a handful or a smaller percentage that were naive patients to any corticosteroids.

早上好，查爾斯。當我們查看迄今為止 AGAMREE 的入組情況時，我們的新入組患者中有 47% 來自目前正在使用 Emflaza 的患者，43% 的患者來自正在使用潑尼鬆的患者，並且只有少數或較小比例的患者是未接受任何皮質類固醇治療的患者。

And then, Charles, your second question, I believe you said the pacing of information from the SUMMIT study. Is that correct?

然後，查爾斯，你的第二個問題，我相信你提到了 SUMMIT 研究中的資訊節奏。那是對的嗎？

Thank you, Charles. The SUMMIT study is scheduled to be a five year study. We anticipate doing analyses approximately once a year, but it would depend on the nature and significance of findings that we observed during the course of the study. At the very least the information will be published and made available to the medical information staff. And at the most it will be submitted to the FDA under the FDA's guidance for real-world data and its use for updating product labeling.

謝謝你，查爾斯。SUMMIT 研究計畫為期五年。我們預計大約每年進行一次分析，但這取決於我們在研究過程中觀察到的發現的性質和意義。至少這些資訊將被公佈並提供給醫療資訊工作人員。最多將在 FDA 對真實世界數據及其用於更新產品標籤的指導下提交給 FDA。

Okay. That's helpful. And then quickly on FIRDAPSE, you're looking forward to the PDUFA date possible dose expansion. Could you remind us of call it roughly what percentage of patients are at maximum dose and how that decision if it is positive to expand dosing might impact demand for further?

好的。這很有幫助。然後很快在 FIRDAPSE 上，您就會期待 PDUFA 日期可能會擴大劑量。您能否提醒我們，粗略地說，接受最大劑量的患者比例是多少？

So Charles, currently 40% of FIRDAPSE patients, active FIRDAPSE patients are on an daily dose of 80 milligrams, which is the maximum there. There are another 4% of patients that are on a dose greater than 80 milligrams, which they work directly with the specialty pharmacy to get that approved.

Charles，目前 40% 的 FIRDAPSE 患者，活躍的 FIRDAPSE 患者每天服用的劑量為 80 毫克，這是那裡的最大劑量。還有 4% 的患者服用的劑量超過 80 毫克，他們直接與專業藥房合作以獲得批准。

And so we do think that there's a significant upside there for patients to find their optimal dose. And over time, we expect the average daily dose, which is currently at around 61 milligrams a day to go up to approximately 65 milligrams or 66 milligrams. That is over time, we expect for a maybe the next the following 12-months post expansion of the label to get to that average daily dose increase.

因此，我們確實認為，患者找到最佳劑量有很大的好處。隨著時間的推移，我們預計平均每日劑量（目前約為每天 61 毫克）將增加至約 65 毫克或 66 毫克。隨著時間的推移，我們預計標籤擴展後的 12 個月內可能會達到平均每日劑量的增加。

Then a final question. BD, going back to the prior question, it seems like you're busy with a AGAMREE launch. I guess, you know, despite the interest in additional assets? Is there a goal for doing that in 2024 or is that really and then on the opportunities?

然後是最後一個問題。BD，回到上一個問題，您似乎忙於 AGAMREE 的發布。我想，你知道，儘管對額外資產感興趣？是否有在 2024 年實現這一目標的目標，或者是否真的有機會實現這一目標？

It's a great question, Charles. We will continue under our under previous leadership to consider a number of opportunities I would say primarily is to get AGAMREE off the launch pad, which I think we're doing a great job getting it off the launch pad, but we want to be sure we have the right opportunity.

這是一個很好的問題，查爾斯。我們將在之前的領導下繼續考慮一些機會，我想說的主要是讓 AGAMREE 離開發射台，我認為我們在讓它離開發射台方面做得很好，但我們想確保我們有合適的機會。

We want to build on the CNS franchise. We want to see some look and see where the opportunities are in the marketplace and do the right deal at the right time. And we want to be sure that we take advantage of those opportunities that come our way and I think we can do additional deals, but the timing and the right deal has to be right for us.

我們希望以 CNS 專營權為基礎。我們希望看看市場上的機會在哪裡，並在正確的時間做出正確的交易。我們希望確保我們能夠利用這些機會，我認為我們可以進行更多交易，但時機和正確的交易必須適合我們。

So we're going to we're going to play it play it smart to benefit the patients, take advantage of the talent in the organization and obviously benefit the shareholders.

因此，我們將巧妙地發揮作用，使患者受益，利用組織中的人才，並明顯地使股東受益。

Jason Gerberry, Bank of America.

傑森‧格伯里，美國銀行。

Hey, guys, thanks for taking my question. One BD question for me and then one AGAMREE question. Just on the BD front. I'm just curious if there's a general profile range in terms of size of deals on stage development that you look at. Would you be willing to bring in an asset that wouldn't deliver sales and profit in the short term?

嘿，夥計們，謝謝你提出我的問題。我先問一個 BD 問題，然後再問一個 AGAMREE 問題。就在BD前面。我只是好奇您所關注的舞台開發交易規模是否有一個總體範圍。您是否願意引入短期內無法帶來銷售和利潤的資產？

And how far down litigation outcomes sort of shape your M&A aperture and then on again, AGAMREE , maybe a little surprised just to hear your lifecycle management discussion this early in the launch. Is this something that you update in the second half could be beneficial within the IP window of AGAMREE or, what are the regulatory exclusivity window of the AGAMREE or something that's kind of a longer term IP. extending approach? If you can comment on that would be great. Thank you.

訴訟結果會在多大程度上影響你的併購孔徑，然後再說一遍，AGAMREE，可能會有點驚訝在發布之初聽到你的生命週期管理討論。您在下半年更新的內容是否可能在 AGAMREE 的智慧財產權窗口內有益，或者 AGAMREE 的監管排他性窗口是什麼，或者是某種較長期的智慧財產權。擴充方法？如果您能發表評論那就太好了。謝謝。

Say thanks for the for the questions. So on the BD side, an opportunity. So we would look for things at this point in our company's life cycle for things that are immediately accretive or nearly immediately accretive. We would want to take advantage of the balance sheet that Mike talked about in the call.

感謝您提出的問題。所以在BD方面，這是一個機會。因此，我們會在公司生命週期的這個階段尋找那些立即增值或幾乎立即增值的東西。我們希望利用麥克在電話中談到的資產負債表。

So when we think about size and opportunity, and we would want to be very thoughtful. We want to look at things that we could add to the company's balance sheet immediately. So I think we would stay within our within ourselves, if you will. I don't want to commit to a size at this point in time.

因此，當我們考慮規模和機會時，我們需要深思熟慮。我們希望研究可以立即添加到公司資產負債表中的內容。所以我認為，如果你願意的話，我們應該留在自己的內心。我現在不想承諾尺寸。

I think we would again assess, but really looking at those things that are very close to market or are on market and again, to continue to build the breadth of our of our capabilities so that we can continue to build and look at larger opportunities in the future as a buy-and-build company.

我認為我們會再次評估，但真正專注於那些非常接近市場或市場上的東西，並再次繼續擴大我們的能力範圍，以便我們能夠繼續建立和尋找更大的機會未來將成為一家購買並建造的公司。

That's what we want to do. We want to build our presence in the market on the how the FIRDAPSE litigation colors, our thought on that. Right now, Steve can speak to the timing of that, but and we assume that we're going to have a significant runway with FIRDAPSE and FIRDAPSE sales. And so we can we have an opportunity to build our portfolio and we're going to take full advantage of that as we can do that for the time being.

這就是我們想做的事。我們希望根據 FIRDAPSE 訴訟的色彩以及我們對此的想法來建立我們在市場上的地位。現在，史蒂夫可以談論這個時機，但我們假設我們將在 FIRDAPSE 和 FIRDAPSE 銷售方面擁有重要的跑道。因此，我們有機會建立我們的投資組合，我們將充分利用這個機會，因為我們暫時可以做到這一點。

Regarding lifecycle management, we believe now is the time to be looking at opportunities for a AGAMREE to build a portfolio of applications for the product in rare and orphan conditions that require a steroid. We want to be that steroid of choice and the companies I've worked in in the past. Typically companies wait too long to think about those things. And so to your point about is it going to be something that's applicable within the window of IP for a AGAMREE?

關於生命週期管理，我們認為現在是時候為 AGAMREE 尋找機會，為需要類固醇的罕見和孤兒疾病建立產品應用組合。我們希望成為我過去工作過的公司和選擇的類固醇。通常情況下，公司會等太久才考慮這些事情。那麼您的觀點是，這是否會適用於 AGAMREE 的 IP 視窗內？

That's exactly the point. That's what we're trying to do is make sure that we can get the studies done, identify those opportunities, get the studies done and then take advantage of it and create value for patients and end and create value for shareholders as well.

這正是重點。我們正在努力做的就是確保我們能夠完成研究，識別這些機會，完成研究，然後利用它為患者創造價值，最終也為股東創造價值。

Samantha Cementbouw with Citi.

Samantha Cementbouw 的花旗銀行。

Good morning. This is Eric on for Sam. Thanks for taking our questions. What do you think is driving the high percentage of patients switching from prednisone in the early launch? And how do you see that evolving as this progresses?

早安.這是埃里克為薩姆發言。感謝您回答我們的問題。您認為是什麼原因導致在早期推出期間大量患者放棄潑尼松？您如何看待隨著事態的發展而演變的情況？

Thanks for your question. We do think that the conversion from prednisone over to a rate is basically because of the safety profile and many of these patients have been on prednisone for a significant amount of time and have seen or experienced those side effects and they're looking to turn they transitioned over to AGAMREE to benefit from the hub, more positive safety profile.

謝謝你的提問。我們確實認為，從潑尼松到速率的轉換基本上是因為安全性，其中許多患者已經服用潑尼鬆很長一段時間，並且已經看到或經歷過這些副作用，他們正在尋求轉變過渡到AGAMREE，以受益於樞紐的更積極的安全狀況。

So on overtime, we do expect this of this mix to be about what it is today, our which is very encouraging initially during our planning and forecasting, we expected the initial launch to be primarily from the influx of patients or those patients that were used to being on a branded cortical steroid. We are encouraged by this because now we've now opened up to the entire cortical steroid market for boys living with DMD. And that's what we're saying. And that's what we expect moving forward.

因此，在加班時，我們確實希望這種組合能夠達到今天的水平，這在我們的規劃和預測過程中最初是非常令人鼓舞的，我們預計最初的啟動將主要來自患者的湧入或使用過的患者服用品牌皮質類固醇。我們對此感到鼓舞，因為現在我們已經向患有 DMD 的男孩開放了整個皮質類固醇市場。這就是我們所說的。這就是我們對未來的期望。

Joe Catanzaro, Piper Sandler.

喬·卡坦扎羅，派珀·桑德勒。

Everybody, thanks so much for taking my questions. Have a view on Dounreay, if I recall correctly, I think you had said there were about 28 patients in the EAP program. Wondering if you could just sort of speak to what percent of those patients have been able to transition to commercial reimbursed drug.

大家，非常感謝您回答我的問題。對Dounreay有一個看法，如果我沒記錯的話，我想你說過EAP計畫中有大約28名患者。想知道您是否可以談談這些患者中有多少百分比能夠過渡到商業報銷藥物。

And then maybe if you could also sort of speak to the current cadence of intake forms, maybe how the current rate compares to your prelaunch experience where you indicated there was a sort of indication of significant and the demand. So wondering if current cadence of intake forms or continues to point to that pent-up demand.

然後，也許您也可以談談當前的接收表格節奏，也許當前的速度與您在啟動前的經歷相比如何，您表示存在某種重要的跡象和需求。所以想知道目前的攝取節奏是否形成或繼續指向被壓抑的需求。

Thanks. And I have maybe one follow-up.

謝謝。我可能還有一個後續行動。

So I can point to first talk about the cadence of the enrollments. We started accepting our pre-commercial launch enrollments in December, and we saw significant pent-up demand. We also knew at that time that there were the centers of excellence that were waiting for an announcement of the official commercial launch date.

所以我可以先談談招生的節奏。我們從 12 月開始接受商業發布前的註冊，我們看到了巨大的被壓抑的需求。當時我們也知道有一些卓越中心正在等待正式商業發布日期的宣布。

So they were holding some enrollments until that announcement post announcement, we started really seeing volume increase that validated our confidence in the launch. And since the commercial launch, we continue to see steady enrollments that Kate, that are hot, steady at a high level higher than what we had forecasted, which is very encouraging. And Joe, can you remind me of your first question about, AGAMREE?

因此，他們保留了一些註冊，直到公告發布後，我們開始真正看到數量的增加，這證實了我們對發布的信心。自商業推出以來，我們繼續看到熱門凱特的入學人數穩定在高於我們預測的高水平，這是非常令人鼓舞的。喬，你能提醒我你關於 AGAMREE 的第一個問題嗎？

Correct, of the 28, over half of those patients are on reimbursed shipments right now, and the rest are still in process?

是的，在這 28 名患者中，超過一半的患者目前正在接受報銷的運送，其餘的患者仍在處理中？

Okay, great. And then maybe my follow-up on still on AGAMREE. You guys had mentioned a step up and 2Q that you're expecting. Maybe you could just help contextualize that a little bit. How much of that will be driven by your patients already on drug seeing a full three months of treatment versus expectations around new patient starts?

好的，太好了。也許我的後續行動仍在 AGAMREE 上。你們提到了你們所期待的升級和第二季。也許你可以幫助我們了解一下具體情況。其中有多少是由已經接受藥物治療的患者接受了整整三個月的治療以及對新患者開始治療的預期所推動的？

Tom, thanks again for taking my question.

湯姆，再次感謝您提出我的問題。

Sure. So just to start off as Jeff mentioned, we saw this nice curve of patients enrolling prior to launch and physicians were waiting. And then with the announcement of the launch, we did see an increased enrollment which was great. So we expect this rollover to happen.

當然。因此，正如傑夫所提到的，我們首先看到了患者在啟動前註冊的良好曲線，而醫生則在等待。隨著發布的宣布，我們確實看到了註冊人數的增加，這非常棒。因此，我們預計會發生這種翻轉。

And as Jeff mentioned in his comments, it takes about currently taking about four weeks to convert these patients from enrollment to reimbursed. So that's going to roll over into the second quarter. So we're really excited about that. And you know, these physicians waiting to further launch. Obviously, now we're going to see that impact in the second quarter. But Jeff, do you want to take the rest of it?

正如傑夫在評論中提到的，目前將這些患者從入組轉為報銷大約需要四個星期的時間。所以這將延續到第二季​​。所以我們對此感到非常興奮。你知道，這些醫生正在等待進一步的啟動。顯然，現在我們將在第二季度看到這種影響。但是傑夫，你想拿走剩下的嗎？

Well said, and we'll have stated Rich. And just to add on to that, we do expect some fee current positive payer landscape too improved even more over time. So that four weeks that Rich mentioned, we expect that to reduce from within six months. We do potentially see it to about one to two weeks from time of complete enrollment to reimburse shipments. That's our expectation. And then the other part, it's balanced by a significant volume of enrollments that we continue to see. So on both ends is where we have to go and why we have confidence in that step-up in Q2.

說得好，我們會說里奇。除此之外，我們確實預計，隨著時間的推移，當前的積極付款人格局也會進一步改善。因此，里奇提到的四個星期，我們預計會在六個月內減少。從完成註冊到報銷運費，我們可能需要大約一到兩週的時間。這是我們的期望。另一方面，我們繼續看到大量的註冊人數來平衡。因此，攻防兩端都是我們必須努力的方向，也是我們對第二季的進步充滿信心的原因。

Thank you. (Operator Instructions)

謝謝。（操作員說明）

Thank you. We have reached the end of our question-and-answer session.

謝謝。我們的問答環節已經結束。

And with that concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。