Catalyst Pharmaceuticals Inc (CPRX) 2024 Q4 法說會逐字稿

Greetings and welcome to the Catalyst Pharmaceuticals fourth quarter in full year 2024 financial results conference call. (Operator Instructions).

問候並歡迎參加 Catalyst Pharmaceuticals 2024 年全年第四季財務業績電話會議。（操作員指令）。

As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Tow. Thank you, and you may begin.

提醒一下，本次會議正在錄音。現在我很高興介紹您的主持人 Mike Tow。謝謝您，您可以開始了。

Good morning everyone and thank you for joining our conference call to discuss Catalyst's fourth quarter and full year 2024 financial results and business highlights. Leading the call today is Richard Daly; Catalyst's President and Chief Executive Officer.

大家早安，感謝您參加我們的電話會議，討論 Catalyst 2024 年第四季和全年財務業績和業務亮點。今天主持電話會議的是理查德戴利 (Richard Daly)； Catalyst 的總裁兼執行長。

We're also joined by Jeff Del Carmen; our Chief Commercial Officer. Further for the Q&A session, Dr. Jeff Del Carmen; our Chief Operating Officer and Chief Scientific Officer, and Dr. Gary Ingenito; our chief medical and regulatory officer, will be available for questions. 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.

我們也邀請了 Jeff Del Carmen；我們的首席商務長。接下來是問答環節，Jeff Del Carmen 博士；我們的營運長和首席科學官以及 ​​Gary Ingenito 博士；我們的首席醫療和監管官將回答您的問題。在我們開始之前，我想提醒您，在我們今天早上的演講和問答環節中，我們將對預期未來結果做出陳述，這些陳述可能是聯邦證券法所指的前瞻性陳述。

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 prove not to be accurate.

這些聲明與我們目前的預期、估計和預測有關，但並不能保證未來的表現。它們涉及難以預測且可能被證明不準確的風險、不確定性和假設。

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 2024 annual report on Form 10k. At this time, I'll turn the call over to Rich.

實際結果可能與我們的前瞻性陳述中的預期有所不同。這些前瞻性陳述僅應與我們提交給美國證券交易委員會 (SEC) 的詳細資訊結合考慮，包括我們 2024 年 10k 表年度報告中所述的風險因素。現在，我將把電話轉給里奇。

Thanks, Mike. Good morning, everyone, and thank you for joining us today. 2024 was an exceptional year marked by record revenue growth and a strong fourth quarter that showcased our scalability and financial strength, reinforcing the success of our strategy. For the full year 2024, total revenues grew by 23.5% year over year to $491.7 million exceeding the upper end of our previous guidance and highlighting our ability to capitalize on market opportunities while maintaining operational excellence.

謝謝，麥克。大家早安，感謝大家今天的參與。 2024 年是個特別的一年，營收成長創紀錄，第四季表現強勁，展現了我們的可擴展性和財務實力，鞏固了我們策略的成功。2024 年全年總收入年增 23.5% 至 4.917 億美元，超過了我們先前預期的上限，並突顯了我們在維持卓越營運的同時利用市場機會的能力。

Full year net product revenue for 2024 reached $489.3 million an exceptional 23.4% increase over 2023, fueled in part by our continued successful launch of Agamri which began on March 13, 2024. In Q4 2024, total revenues and net product revenues reached a record $141.8 million an increase of 28.3% and 30% over Q4 2023 respectively.

2024 年全年淨產品收入達到 4.893 億美元，比 2023 年成長 23.4%，部分原因是我們於 2024 年 3 月 13 日開始成功推出 Agamri。2024 年第四季，總營收和淨產品收入達到創紀錄的 1.418 億美元，分別比 2023 年第四季成長 28.3% 和 30%。

The increase was driven by the continued organic growth of FirdApps, steady contributions of FICOMPA, and new revenue from a Agamri, which accounted for a portion of the year over year increase. Looking ahead, we expect this momentum to continue with 2025 total revenue forecasted to be between $545 million and $565 million. We ended the year with a robust cash position of $517.6 million and no debt, providing an enhanced capacity to invest in strategic growth opportunities.

這一增長主要得益於 FirdApps 的持續有機增長、FICOMPA 的穩定貢獻以及來自 Agamri 的新收入，這佔了同比增長的一部分。展望未來，我們預計這股動能將持續下去，2025 年總營收預計在 5.45 億美元至 5.65 億美元之間。截至今年年底，我們的現金狀況強勁，達到 5.176 億美元，且沒有債務，這增強了我們投資策略成長機會的能力。

Catalyst's competitive advantage is built on the commitment of our outstanding team and the strength of our patient engagement services such as Catalyst pathways. Additionally, our strong relationship with healthcare and rare disease communities drives meaningful stakeholder engagement. Together our holistic approach enables the patients we serve to streamline access. Identify appropriate therapy, receive timely treatment, and remain compliant with their care.

Catalyst 的競爭優勢建立在我們優秀團隊的承諾以及我們的病患參與服務（例如 Catalyst 途徑）的實力之上。此外，我們與醫療保健和罕見疾病社區的牢固關係推動了有意義的利害關係人參與。我們採用的整體方法能夠簡化我們服務的病人就醫流程。確定適當的治療方法，及時接受治療，並堅持護理。

Sustained momentum reflects the strength of this approach, delivering 14 consecutive quarters of 15% or more growth year over year. As the only evidence-based treatment for lens in the US, we believe that F FirdApps is well positioned to maintain this trajectory for the foreseeable future. Given the incredible benefits FirdApps offers to patients and the opportunity for continued growth, we remain committed to building this therapy. Jeff will discuss this in greater detail later in the call.

持續的勢頭反映了這種方法的優勢，連續 14 個季度實現了同比增長 15% 或更高。作為美國唯一以證據為基礎的晶狀體治療方法，我們相信 F FirdApps 在可預見的未來有能力維持這一發展軌跡。鑑於 FirdApps 為患者提供的巨大益處和持續成長的機會，我們將繼續致力於開發這種療法。傑夫將在稍後的通話中更詳細地討論這一點。

In January 2025, we secured a favorable resolution to the TeVA patent litigation prohibiting Teva's generic entry until February 2035 absent other occurrences and reinforcing FirdApps's intellectual property strength. The litigation between the remaining two generic first filers is ongoing. And we remain fully committed to doing everything we can to protect the long-term value of our franchise.

2025 年 1 月，我們對 TeVA 專利訴訟達成了有利的解決方案，除非發生其他情況，否則禁止 Teva 在 2035 年 2 月之前進入仿製藥市場，並增強了 FirdApps 的智慧財產權實力。其餘兩家通用藥物首次申請人之間的訴訟仍在進行中。我們將繼續全力致力於盡一切努力保護我們特許經營的長期價值。

Turning to Agamri Since its launch in March 2024, Agamri has gained significant traction, securing share from both branded and generic sides of the market. This is a true testament to the market's recognition of a Agamri's potential differentiation. We've had great success and broad acceptance in many DMV centers of excellence, and we now turn our efforts to going deeper into the COEs to help more patients experience the potential benefits of this unique steroid.

轉向 Agamri 自 2024 年 3 月推出以來，Agamri 獲得了顯著的關注，並獲得了品牌和仿製藥市場的份額。這真實證明了市場對 Agamri 潛在差異化的認可。我們在許多 DMV 卓越中心取得了巨大的成功和廣泛的認可，現在我們將努力深入 COE，以幫助更多患者體驗這種獨特類固醇的潛在益處。

As the Agamri enters its second year, we expect the adoption momentum to evolve to a sustained growth trajectory, reinforcing confidence in the long-term growth potential. The summit study is up and running, enrolling patients. This is a key long term initiative to provide insight into a Agamri's unique therapeutic profile and strengthen its market position.

隨著阿加姆裡 (Agamri) 進入第二年，我們預計採用動能將演變為持續成長軌跡，從而增強對長期成長潛力的信心。高峰會研究正在進行中，正在招募患者。這是一項重要的長期舉措，旨在深入了解 Agamri 獨特的治療特性並加強其市場地位。

This five year open label study aims to provide real world data versus historic control. We look forward to working with the participating centers on enrollment and future data analyses. Phi Kappa has established strong patient preference due to its proven efficacy and benefits and seizure control. We are proactively implementing targeted strategies to manage FICOMPA's life cycle ahead of its expected patent breed in May of 2025.

這項為期五年的開放標籤研究旨在提供真實世界數據與歷史對照。我們期待與參與中心就招生和未來的數據分析展開合作。Phi Kappa 憑藉其公認的療效和益處以及對癲癇的控製而贏得了患者的強烈青睞。我們正在積極實施有針對性的策略，以便在 FICOMPA 預計於 2025 年 5 月獲得專利之前管理其生命週期。

We anticipate a gradual revenue decline in the second half of 2025 as physicians and patients prioritize clinical stability with a continued decline in 2026 and beyond as payer-driven transitions accelerate. Jeff will provide an overview of our commercial performance followed by Mike's financial update later in the call. As we execute our strategic priorities, our buy and build approach remains a core pillar of our long-term growth driven by disciplined business development.

我們預計，由於醫生和患者優先考慮臨床穩定性，2025 年下半年收入將逐漸下降；而隨著付款人驅動的轉型加速，2026 年及以後收入將繼續下降。傑夫將在電話會議中概述我們的商業表現，隨後麥克將介紹財務最新情況。在我們執行策略重點時，我們的購買和建設方式仍然是我們由嚴謹的業務發展推動的長期成長的核心支柱。

We are actively evaluating several accretive and near accretive rare disease opportunities, prioritizing strong clinical differentiation and a clear commercialization potential. While we have not yet found the right opportunity, we continue to make significant progress on this front, leveraging our rigorous due diligence process in an effort to secure the right assets at the right time to drive sustainable success.

我們正在積極評估幾種增值型和接近增值的罕見疾病機會，優先考慮強大的臨床差異化和明確的商業化潛力。雖然我們還沒有找到合適的機會，但我們在這方面繼續取得重大進展，利用我們嚴格的盡職調查流程，努力在合適的時間獲得合適的資產，以推動可持續的成功。

Our international strategy has two core elements. First, we are building a sustainable network of outlicensing partners with whom we can rapidly transact in the future, a plug and play strategy. Second As with our approach in the US, we seek markets where our products can make a difference, ones in which our products would represent a differentiated offering.

我們的國際戰略有兩個核心要素。首先，我們正在建立一個可持續的對外授權合作夥伴網絡，未來我們可以與他們快速進行交易，這是一種即插即用策略。第二，與我們在美國採取的策略一樣，我們尋求我們的產品能夠發揮作用的市場，在這些市場中我們的產品能夠代表差異化的產品。

Enhance access to care and improve health equity. In January 2025, our sub licensee Dido Pharma successfully launched FirdEPS in Japan, expanding access for lens patients in this key market. Meanwhile, Kai Pharmaceuticals, our licensee in Canada, remains on track to submit a new drug submission for Agamri to Health Canada in early 2025. As part of our strategic focus, we remain vigilant in navigating market and regulatory challenges, including evolving healthcare policies and a shifting competitive landscape.

增強獲得醫療服務的機會並改善健康公平。2025 年 1 月，我們的分許可證持有者 Dido Pharma 在日本成功推出了 FirdEPS，擴大了這個關鍵市場的晶狀體患者獲得治療的機會。同時，我們在加拿大的授權商 Kai Pharmaceuticals 仍計劃於 2025 年初向加拿大衛生部提交 Agamri 的新藥申請。作為我們策略重點的一部分，我們始終保持警惕，以應對市場和監管挑戰，包括不斷變化的醫療保健政策和不斷變化的競爭格局。

By staying agile and adapting to industry changes, we are well positioned to manage risks and drive growth. Leveraging our rare disease expertise and operational excellence, we believe that we are well positioned to drive sustained growth and capitalize on emerging opportunities for long term value. Now I'd like to turn the call over to Jeff Del Carmen, our Chief Commercial Officer. Jeff.

透過保持敏捷並適應行業變化，我們能夠更好地管理風險並推動成長。利用我們在罕見疾病方面的專業知識和卓越的運營，我們相信我們有能力推動持續成長並利用新興機會實現長期價值。現在我想將電話轉給我們的商務長傑夫德爾卡門 (Jeff Del Carmen)。傑夫。

Thanks, Rich, and good morning everyone. We are thrilled with our exceptional performance in 2024, marked by full year net product revenue of $489.3 million in total revenues of $491.7 million surpassing the upper end of our 2024 full year total revenue guidance of $475 million to $485 million.

謝謝，Rich，大家早安。我們對 2024 年的出色表現感到非常高興，全年淨產品收入為 4.893 億美元，總收入為 4.917 億美元，超過了我們 2024 年全年總收入預期的上限 4.75 億美元至 4.85 億美元。

This outstanding achievement was driven by FirdApps's full year revenue, reaching a record high of $306 billion. The successful US commercial launch of a Agamri and the continued strong contribution from FICOMPA. Let's start by reviewing our advancements with FirdApps, the only evidence-based FDA approved treatment for Lambert-Eaton Myasthenic syndrome. In the fourth quarter, net product revenue amounted to $82.5 million, showcasing a remarkable 18.3% year over year growth.

這項傑出成就的推動因素是 FirdApps 全年營收達到創紀錄的 3,060 億美元。Agamri 在美國成功商業上市，FICOMPA 持續做出強勁貢獻。讓我們先回顧一下我們在 FirdApps 方面取得的進展，這是唯一獲得 FDA 批准的基於證據的 Lambert-Eaton 肌無力症候群治療方法。第四季度，淨產品收入達8,250萬美元，年增18.3%。

Furthermore, FIA's net product revenue for 2024 showed strong 18% growth year over year, driven by a steady influx of new patient initiations and a low annual discontinuation rate of under 15%, exceeding internal expectations. Prescription approval rates exceeded 90% for all types of payers, including government and private commercial insurers. Patients enrolled in Catalyst pathways, including those with Medicare coverage, accessing third party foundation assistance, experienced an average monthly co-pay of less than $2.

此外，由於新患者的穩定湧入和低於 15% 的年停藥率，FIA 2024 年的淨產品收入同比強勁增長 18%，超出了內部預期。包括政府和私人商業保險公司在內的各類付款人的處方批准率均超過 90%。參加 Catalyst 途徑的患者（包括享有醫療保險的患者）獲得第三方基金會的援助後，平均每月自付費用不到 2 美元。

Now I'd like to turn to a Agamri. We are proud of a Agamri's successful commercial launch and its growing recognition as a breakthrough treatment for Duchenne muscular dystrophy. Full year 2024 net product revenue reached $46 million surpassing the revised guidance of $40 million to $45 million. In Q4 2024, Agamri delivered strong net sales of $21.1 million driven by increasing adoption.

現在我想談談阿加姆裡 (Agamri)。我們為 Agamri 的成功商業化上市和其作為杜氏肌肉營養不良症突破性治療方法日益受到認可而感到自豪。2024 年全年淨產品收入達到 4,600 萬美元，超過了修訂後的 4,000 萬美元至 4,500 萬美元的預期。2024 年第四季度，由於採用率不斷提高，Agamri 實現了 2,110 萬美元的強勁淨銷售額。

Adoption has been robust, with 93% of the top 45 DMD centers of excellence and 209 unique healthcare providers submitting enrollments for a Agamri. We continue to see strong transitions from both corticosteroid segments, with 44% coming from prednisone and 43% coming from En Plaza. Additionally, 85% of shipments were reimbursed with an average approval time of approximately nine business days after we received a completed enrollment form.

採用情況一直很強勁，全球排名前 45 位的 DMD 卓越中心中有 93% 和 209 家獨特的醫療保健提供者均已提交 Agamri 的註冊申請。我們繼續看到皮質類固醇兩個領域的強勁轉變，其中 44% 來自潑尼松，43% 來自 En Plaza。此外，我們收到填寫完整的登記表後，85％的貨物運費得到了報銷，平均審批時間為約九個工作天。

We anticipate further reductions in approval time as payers finalize their policies in the coming months. Lastly, I would like to provide a brief overview of FICOMPA. For the fourth quarter of 2024, FICOMPA delivered strong results supported by steady demand that reinforced its market position. Q4 2024 net product revenue of $38.2 million further strengthened our revenue diversification. FICOMPA's full year 2024 net product revenue reached $137.3 million, surpassing our guidance range of $130 million to $135 million.

隨著付款人在未來幾個月內最終確定其政策，我們預計審批時間將進一步縮短。最後，我想簡單介紹 FICOMPA。2024 年第四季度，在穩定的需求支持下，FICOMPA 取得了強勁的業績，鞏固了其市場地位。2024 年第四季的淨產品收入為 3,820 萬美元，進一步加強了我們的收入多樣化。FICOMPA 2024 年全年淨產品收入達到 1.373 億美元，超過了我們 1.3 億美元至 1.35 億美元的預期範圍。

To enhance our focus on the markets for FirdApps and Agamri, we have made a strategic decision to divide our commercial field-based team into two dedicated units. The FirdApps field force will consist of 16 regional account managers, while the Agamri field force will include 12 regional account managers. We anticipate implementing this focused approach by early Q2 with most of the additional headcount filled by internal personnel.

為了加強對 FirdApps 和 Agamri 市場的關注，我們做出了一項策略決策，將我們的商業領域團隊劃分為兩個專門部門。FirdApps 現場團隊將由 16 名區域客戶經理組成，而 Agamri 現場團隊將包括 12 名區域客戶經理。我們預計將在第二季初實施此重點方法，大部分額外員工將由內部人員填補。

We are confident that FirdApps's organic growth in 2025 will exceed 15%, driven by several key factors. The continued conversion of a portion of the 500 plus identified lens patients to [FIRAF's] treatment will be a significant contributor. Additionally, the approval of the expanded 100 mg label in June 2024 enables patients to access a higher daily dose when appropriate, further supporting growth.

我們相信，在幾個關鍵因素的推動下，FirdApps 在 2025 年的有機成長將超過 15%。將 500 多名已確診的晶狀體患者中的一部分繼續轉為接受 [FIRAF] 治療將發揮重要作用。此外，2024 年 6 月批准擴大 100 毫克標籤，使患者能夠在適當的時候獲得更高的每日劑量，從而進一步支持成長。

Furthermore, we are well positioned to capitalize on the cancer associated lens opportunity by shifting our focus to community-based oncology physicians who we estimate treat approximately 85% of all cancer patients. We expect that this strategic pivot will allow us to more effectively target the approximately 90% of small cell lung cancer lens patients who remain undiagnosed. Our efforts will center on implementing BGCC antibody screening programs with major GPOs accelerating lens diagnosis rates.

此外，我們將把重點轉移到社區腫瘤科醫生身上，充分利用癌症相關的鏡片機會，我們估計社區腫瘤科醫生治療了大約 85% 的癌症患者。我們預計，這項策略轉變將使我們能夠更有效地針對約 90% 未確診的小細胞肺癌晶狀體患者。我們的努力將集中在實施 BGCC 抗體篩檢計劃，並與主要 GPO 一起加速晶狀體診斷率。

In 2025, the dedicated field force will create deeper adoption of a Agamri in the approximately 100 DMDCOEs, allowing for continued growth following the initial surge of early adopters. The crowded DMD landscape has created a competition for share of voice within these institutions. In addition, we believe there is a queuing effect for patients as they are evaluated for treatment. Of new therapies delaying initiation of a Agamri for some patients.

2025 年，專門的現場團隊將在約 100 個 DMDCOE 中更深入地採用 Agamri，從而實現在早期採用者激增之後的持續成長。擁擠的 DMD 市場環境導致了這些機構內部對話語權的競爭。此外，我們認為患者在接受治療評估時存在排隊效應。對於某些患者來說，新的療法可以延遲開始使用 Agamri 藥物。

However, we remain confident that our dedicated Agamri field force will continue to expand Agamri's adoption across both prednisone and plaza segments. Finally, as we mentioned by Compaluza's exclusivity in May 2025, we will continue to leverage personal promotion through LOE due to the promotional sensitivity with anti-seizure medications.

然而，我們仍然相信，我們敬業的 Agamri 現場團隊將繼續擴大 Agamri 在潑尼松和廣場領域的應用。最後，正如我們在 2025 年 5 月 Compaluza 的獨家經營權中所提到的那樣，由於抗癲癇藥物的促銷敏感性，我們將繼續透過 LOE 進行個人促銷。

In summary, our exceptional performance in 2024 reflects the strength of our product portfolio and our ability to meet the needs of diverse patient populations. Strategic investments in marketing, education, and patient support have been pivotal to this success, and we are committed to building on this momentum. We look forward to driving sustained commercial execution and making a meaningful impact on the patient communities we serve.

總而言之，我們在 2024 年的卓越表現反映了我們產品組合的實力以及滿足不同患者群體需求的能力。在行銷、教育和患者支援方面的策略性投資對這一成功至關重要，我們致力於繼續保持這一勢頭。我們期待推動持續的商業執行並對我們服務的患者群體產生有意義的影響。

I expressed sincere appreciation to the entire Catalyst team for their unwavering dedication to patients. I eagerly look forward to a prosperous year ahead. I will now turn the call back over to Mike.

我對整個 Catalyst 團隊為患者所做的不懈奉獻表示誠摯的感謝。我熱切期盼新的一年繁榮昌盛。我現在將電話轉回給麥克。

Thank you, Jeff. As Rich and Jeff mentioned, Catalyst's fourth quarter and full year 2024 financial performance resulted in another record breaking year driven by exceptional execution by all facets of our business.

謝謝你，傑夫。正如 Rich 和 Jeff 所提到的，Catalyst 第四季和 2024 年全年的財務表現再創紀錄，這得益於我們業務各個方面的出色執行。

In addition to our outstanding results, I would like to highlight the incredible work done by the Catalyst team with the commercial launch of Agamri in March of 2024. Now on to 2024 results. Our total revenues for 2024 were $491.7 million a 23.5% increase when compared to total revenues of $398.2 million for 2023. Product revenue net for 2024 from our lead product for apps was $306 million and 18.4% increase year over year compared to $258.4 million for 2023.

除了我們出色的成果之外，我還想強調一下 Catalyst 團隊在 2024 年 3 月推出 Agamri 商業版本時所做的出色工作。現在來看看 2024 年的結果。我們 2024 年的總營收為 4.917 億美元，與 2023 年的 3.982 億美元總營收相比成長了 23.5%。2024 年，我們主打應用程式產品的產品淨收入為 3.06 億美元，與 2023 年的 2.584 億美元相比成長 18.4%。

Product revenue net for Agamri was $46 million for the period from the commercial launch on March 13, 2024 through year end. Product revenue net for FICOMPA was $137.3 million compared to $138.1 million for 2023. As mentioned previously, 2024 FICOMPA net product revenue was adversely affected by gross to net changes compared to 2023 when our gross to net for FICOMPA was booked under Assad's more favorable arrangements with distributors and government agencies.

從 2024 年 3 月 13 日商業發佈到年底，Agamri 的產品淨收入為 4,600 萬美元。FICOMPA 的產品淨收入為 1.373 億美元，而 2023 年為 1.381 億美元。如前所述，與 2023 年相比，2024 年 FICOMPA 淨產品收入受到毛利與淨利變化的不利影響，當時 FICOMPA 的毛利與淨利是根據阿薩德與分銷商和政府機構達成的更有利的安排入賬的。

Starting in 2024, all such costs have been tied to arrangements between us and those distributors and government agencies. Since our costs under these arrangements are higher than the size costs, we were impacted by an increase in gross to net deductions for FICOMPA therapy, causing a corresponding decrease in FICOMPA net product revenue.

從 2024 年開始，所有此類成本都與我們與這些經銷商和政府機構之間的安排掛鉤。由於我們在這些安排下的成本高於規模成本，我們受到 FICOMPA 治療的總扣除額至淨扣除額增加的影響，導致 FICOMPA 淨產品收入相應減少。

During 2024 we recognized approximately $2.4 million in license and other revenue which consisted primarily of a $2.1 million milestone payment earned upon Dido receiving product approval to commercialize [furaps] for the treatment of patients with [lims] in Japan. 2023 license and other revenue was approximately $1.7 million which included a $1.4 million milestone earned as a result of data submitting a Japan NDA preferred apps to the Pharmaceutical and Medical Devices Agency in Japan.

2024 年，我們確認了約 240 萬美元的許可和其他收入，其中主要包括 Dido 獲得產品批准將 [furaps] 商業化用於在日本治療 [lims] 患者時獲得的 210 萬美元里程碑付款。 2023 年許可證和其他收入約為 170 萬美元，其中包括向日本藥品和醫療器材管理局提交日本 NDA 首選應用程式資料所獲得的 140 萬美元里程碑收入。

For 2025 we are forecasting FDA's net product revenue to be between $355 million and $360 million which also reflects an increase in the US gross to net driven by the Inflation Reduction Act, or IRA impact on our Medicare Part DRA sales. We expect that the IRA impact will continue to increase annually. We are forecasting a Gambi 2025 in net product revenue to be between $100 million and $110 million and we are forecasting FICOMPA 2025 net product revenue to be between $90.95 million dollars.

我們預測，到2025年，FDA 的淨產品收入將在3.55億美元至3.6億美元之間，這也反映了受通膨削減法案推動的美國毛收入與淨收入的成長，或 IRA 對我們的 Medicare Part DRA 銷售的影響。我們預計 IRA 的影響力將逐年增加。我們預測 Gambi 2025 年的淨產品收入將在 1 億美元至 1.1 億美元之間，而我們預測 FICOMPA 2025 年的淨產品收入將在 9,095 萬美元之間。

In 2025, FICOMPA net product revenue will be impacted by the loss of exclusivity in the anticipated generic entrance into the FICOMPA market. Finally, based on Dido's commercialization of FirdApps in Japan, we expect to record some revenue which is included in the FirdApps's guidance based on the sale of FirdApps to Dido in lieu of receiving royalties.

2025 年，預計仿製藥將進入 FICOMPA 市場，而其獨佔權的喪失將對 FICOMPA 淨產品收入產生影響。最後，基於 Dido 在日本對 FirdApps 的商業化，我們預計將記錄一些收入，這些收入包含在 FirdApps 的指導中，基於將 FirdApps 出售給 Dido 而不是收取版稅。

While we do not expect our 2025 revenue from sales to Dido to be material, we believe that our global expansion to make our product available to LEMS patients in other jurisdictions to be an important element of our business plan.

雖然我們並不預期 2025 年從對 Dido 的銷售中獲得可觀的收入，但我們相信，全球擴張，讓其他司法管轄區的 LEMS 患者也能使用我們的產品，是我們商業計劃的重要組成部分。

We reported US GAAP net income for 2024 of $163.9 million or $1.38 per basic and $1.31 per diluted share, an increase of 130% year over year compared to GAAP net income for 2023 of $71.4 million or $0.67 per basic and $0.63 per diluted share. The increase in net income year over year is attributable to growth in FirdApps's net product revenue and the addition of net product revenue resulting from the launch of a gaming.

我們報告稱，2024 年美國 GAAP 淨收入為 1.639 億美元，即基本每股 1.38 美元，稀釋每股 1.31 美元，較 2023 年 GAAP 淨收入 7,140 萬美元，即基本每股 0.67 美元，稀釋每股 0.63 美元同比增長 130%。淨收入年增率歸因於 FirdApps 淨產品收入的成長以及遊戲推出帶來的淨產品收入的增加。

Additionally, in 2023, we recorded the one-time Agamri related $81.5 million dollar acquisition-related IP R&D expense. Non-gap net income for 2024 was $276.3 million or $2.33 per basic and $2.21 per diluted share. Which excludes the income tax provision of $52.4 million amortization of intangible assets related to our acquisitions of reserveifi comp and Agamri of $37.4 million stock-based compensation expense of $22.3 million and depreciation of $397,000 from GAAP net.

此外，2023 年，我們記錄了與 Agamri 相關的一次性 8,150 萬美元收購相關 IP 研發費用。2024 年非缺口淨收入為 2.763 億美元，即每股基本收入 2.33 美元，每股稀釋收入 2.21 美元。這並不包括所得稅準備金 5,240 萬美元、與我們收購 Reserveifi Comp 和 Agamri 相關的無形資產攤銷 3,740 萬美元、股票薪資費用 2,230 萬美元以及 GAAP 淨值的 397,000 美元折舊。

This compares to non-gap net income for 2023 of $141.6 million or $1.33 per basic and $1.25 per diluted share, which excludes the income tax provision of $23.1 million. Amortization of intangible assets of $32.6 million stock-based compensation expense of $14.3 million and depreciation of $316,000 from GAAP net income. These non-gap results represent an approximate 95% increase of non-gap net income year over year.

相較之下，2023 年的非缺口淨收入為 1.416 億美元，即每股基本收入 1.33 美元，每股稀釋收入 1.25 美元，不包括 2,310 萬美元的所得稅準備金。無形資產攤提 3,260 萬美元，股票薪酬費用 1,430 萬美元，折舊 316,000 美元，來自 GAAP 淨收入。這些無差距結果顯示無差距淨收入年增約 95%。

As a reminder in Q3 2023, we acquired a Agamri commercial rights in advance of US FDA approval, which required that the company expense the acquired IPR&D at the time of the acquisition. Our cost of sales in 2024 was approximately $68.8 million compared to $52 million in 2023 and consisted principally of royalties. Agamri royalties paid to the product license are increased based on different net sales criteria.

提醒一下，在 2023 年第三季度，我們在美國 FDA 批准之前收購了 Agamri 商業權利，這要求公司在收購時將獲得的 IPR&D 作為費用。我們 2024 年的銷售成本約為 6,880 萬美元，而 2023 年為 5,200 萬美元，主要由特許權使用費組成。Agamri 支付給產品許可的特許權使用費會根據不同的淨銷售額標準而增加。

For 2025, we expect the Agamri royalties to increase as a percentage of net sales compared to 2024 based on our net product revenue guidance of $100 million to $110 million. The Company is also required to make a $12.5 million dollar milestone payment to our product licensor once the Agamri's net product revenue in a calendar year reaches $100 million.

根據我們 1 億至 1.1 億美元的淨產品收入預期，我們預計 2025 年 Agamri 特許權使用費佔淨銷售額的百分比將比 2024 年增加。一旦 Agamri 在一個日曆年內的淨產品收入達到 1 億美元，公司還需要向我們的產品授權人支付 1,250 萬美元的里程碑付款。

Further, we are required to pay royalties based on net product revenue to the product licensor for FICOMPA following the loss of exclusivity, which will occur in May 2025 for the tablets and in November 2025 for the oral suspension. The royalty rates are higher if there is no generic entry following loss of patent exclusivity than they are once generics enter the market. Research and development expenses were $12.6 million in 2024 compared to $93.2 million in 2023.

此外，在失去獨佔權後，我們需要根據淨產品收入向 FICOMPA 的產品授權人支付特許權使用費，對於片劑，我們將在 2025 年 5 月支付特許權使用費，對於口服混懸劑，我們將在 2025 年 11 月支付特許權使用費。如果在專利獨佔權喪失後沒有仿製藥進入市場，則專利費率會高於仿製藥進入市場後的專利費率。2024 年研發費用為 1,260 萬美元，而 2023 年為 9,320 萬美元。

As previously mentioned, the driver behind the decrease in research and development expenses relates to a one-time Agamri IPR&D expense of approximately $81.5 million during the third quarter of 2023. Relative to the normal course of business, absent another acquisition, we are forecasting research and development costs in 2025 to be between $15 million and $20 million dollars.

如前所述，研發費用下降的原因與 2023 年第三季約 8,150 萬美元的一次性 Agamri IPR&D 費用有關。相對於正常業務流程，如果沒有其他收購，我們預測 2025 年的研發成本將在 1,500 萬美元至 2,000 萬美元之間。

We anticipate that our R&D expenses in future years may become more significant if we seek to execute on the development of additional indications for FirdApps and Agamri or if we acquire additional products still in development. SNA expenses for 2024 totaled $177.7 million compared to $133.7 million in 2023.

我們預計，如果我們尋求開發 FirdApps 和 Agamri 的更多適應症或收購仍在開發中的其他產品，未來幾年我們的研發費用可能會變得更加巨大。2024 年 SNA 支出總計 1.777 億美元，而 2023 年為 1.337 億美元。

The increase in SGNA year over year is principally due to expenses related to Agamri , including commercial support expenses, selling and marketing expenses, and an increase in corporate headcount required to support the expanding company infrastructure.

SGNA 的同比增長主要是由於與 Agamri 相關的費用，包括商業支援費用、銷售和行銷費用，以及支持不斷擴大的公司基礎設施所需的公司員工人數的增加。

We anticipate 2025 SGNA expenses to increase compared to 2024, primarily driven by increased headcount, including full year costs for individuals hired throughout 2024 in certain functional areas to support the growth of our business and our overall strategy as we focus on expanding our product portfolio and the launch of separate commercial and medical field forces for apps and Agamri, which is scheduled to commence at the beginning of the second quarter.

我們預計 2025 年 SGNA 費用將較 2024 年增加，主要原因是員工人數增加，包括 2024 年全年在某些職能領域僱用的個人的全年成本，以支持我們業務的增長和我們的整體戰略，因為我們專注於擴大我們的產品組合和為應用程序和 Agamri 推出單獨的商業和醫療領域力量，於第二季度初開始。

Our effective tax rate for 2024 was 24.2% compared to 24.4% for 2023. 2024, the difference to the statutory federal income tax rate of 21% was primarily driven by state income taxes and anticipated annual permanent differences. We anticipate that our effective tax rate for 2025 will be relatively consistent with our 2024 and 2023 tax rates. It is important to note that our tax rate is affected by many factors, including the number of stock options exercised, state tax rates impacting our business, and other items in any given period and is likely to fluctuate in future periods.

我們 2024 年的有效稅率為 24.2%，而 2023 年為 24.4%。 2024 年，與法定聯邦所得稅率 21% 的差異主要是由州所得稅和預期的年度永久性差異造成的。我們預計 2025 年的有效稅率將與 2024 年和 2023 年的稅率相對一致。值得注意的是，我們的稅率受多種因素影響，包括行使的股票選擇權數量、影響我們業務的州稅率以及任何特定期間的其他項目，並且可能在未來期間內波動。

I would like to emphasize that this is an annualized effective tax rate which is not directly correlated to quarterly net income before income taxes and may be higher or lower on a quarter to quarter basis depending on how the company is trending against annualized net income before income taxes. As we reported, we ended 2024 with cash and cash equivalents of $517.6 million compared to $137.6 million at December 31, 2023.

我想強調的是，這是一個年度有效稅率，與季度稅前淨收入沒有直接關係，並且可能根據公司相對於年度稅前淨收入的趨勢而逐季度升高或降低。正如我們所報告的，截至 2024 年，我們的現金和現金等價物為 5.176 億美元，而 2023 年 12 月 31 日為 1.376 億美元。

The increasing cash of approximately $380 million was largely driven by approximately $240 million in cash provided by operating activities, as well as approximately $141 million raised in the January 2024 capital raise. We believe that our current funds continue to allow us the financial flexibility to fund our existing R&D activities, meet our potential contractual obligations. And support our strategic initiatives, business development, and portfolio expansion efforts leading to long term growth and value creation.

約 3.8 億美元的現金增加主要得益於經營活動提供的約 2.4 億美元現金，以及 2024 年 1 月融資中籌集的約 1.41 億美元。我們相信，我們目前的資金可以繼續讓我們擁有財務靈活性，為現有的研發活動提供資金，並履行我們潛在的合約義務。並支持我們的策略計劃、業務發展和投資組合擴展努力，從而實現長期成長和價值創造。

More detailed information and analysis of our full year 2024 financial performance may be found in our annual report on Form 10k, which was filed with the Securities and Exchange Commission yesterday, February 26, 2025, and can be found on the investor relations page of our website at www.catalystpharma.com And with that, I will turn the call back over to Rich.

有關我們 2024 年全年財務表現的更多詳細資訊和分析，請參閱我們昨天（2025 年 2 月 26 日）向美國證券交易委員會提交的 10k 表年度報告，也可在我們網站 www.catalystpharma.com 的投資者關係頁面上找到。說完這些，我會把電話轉回給 Rich。

As we embark on 2025, we are energized by the opportunities ahead and remain focused on delivering meaningful advancements for patients with rare diseases. Our passion, expertise, and unwavering commitment will continue to drive us forward as we execute our strategic priorities and expand our impact. I want to extend my gratitude to our employees, partners, and stakeholders for their dedication and support.

當我們邁入 2025 年時，我們對未來的機會充滿期待，並將繼續致力於為罕見疾病患者帶來有意義的進步。在我們執行策略重點和擴大影響力的過程中，我們的熱情、專業知識和堅定不移的承諾將繼續推動我們前進。我要向我們的員工、合作夥伴和利害關係人的奉獻和支持表示感謝。

Your contributions are instrumental in our success, and I look forward to what we will accomplish together in the year ahead. I'd like to turn the call back to the operator.

您的貢獻對我們的成功至關重要，我期待著我們在新的一年裡共同取得成就。我想把電話轉回接線生。

Thank you.

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。（操作員指令）

Our first question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your questions.

我們的第一個問題來自 Cantor Fitzgerald 的 Charles Duncan。請繼續提出您的問題。

Thank you. Morning, Rich and team. Congrats on a great year of progress and thanks for taking our question. I had a question about FirdApps and really the guidance. I'm wondering if Jeff can provide a little bit more color on the new patient ads as well as the low discontinuation rate that you're seeing. And then with regard to guidance for FirdApps, it's fairly narrow, 355 to 360 versus, for example, Agamri which is broader and and I I'm kind of wondering why you have so much precision on the guidance at this at this stage with regard to FirdApps. Thanks.

謝謝。早上好，Rich 和團隊。恭喜您在過去一年中取得的巨大進步，並感謝您回答我們的問題。我對 FirdApps 及其指導確實有疑問。我想知道傑夫是否可以提供更多關於新患者廣告以及您所看到的低停藥率的詳細資訊。然後關於 FirdApps 的指導，它相當狹窄，355 到 360，而例如 Agamri 的範圍更廣，而且我有點好奇為什麼您在現階段對 FirdApps 的指導如此精確。謝謝。

Well, thanks for the question. Obviously, we have a lot more experience with FirdApps and I think Jeff, I'll turn the call over to Jeff, but the pool of patience that we have and the continued confidence that we have in the in the brand and the uptake, I think Jeff can speak to that more.

嗯，謝謝你的提問。顯然，我們在 FirdApps 方面擁有更多的經驗，我想傑夫，我會把電話轉給傑夫，但我們擁有的耐心以及對品牌和接受度的持續信心，我想傑夫可以更多地談談這一點。

More clearly than I can. So Jeff.

比我清楚得多。所以傑夫。

Thanks Rich and good morning, Charles.

謝謝 Rich，早上好，Charles。

As we've mentioned, we have over 500 plus pipeline leads, and those are those patients that are diagnosed with lens but not yet on FirdApps. Those patients typically contribute about 50% to our new enrollments each month or any given quarter, so we have a good handle on that. What's what we have. Front of us and how when we can help those patients transition onto therapy. So that gives us confidence in that sense. Also, the discontinuation rate has been very steady since we launched this back in 2019 and actually in 2024 full year, the annual discontinuation rate was 15%.

正如我們所提到的，我們有超過 500 條管道線索，這些線索都是被診斷患有晶狀體但尚未使用 FirdApps 的患者。這些患者通常為我們每月或每季的新入院人數貢獻約 50%，因此我們對此有很好的把握。我們有什麼。我們面臨的問題是，我們如何幫助這些患者過渡到治療階段。從這個意義上來說，這給了我們信心。此外，自 2019 年推出以來，停產率一直非常穩定，實際上 2024 年全年的年停產率為 15%。

So that was very strong. So we're very confident about that and as rich mentioned our experience with this product and what we've seen it, it's what you see typically with rare disease products in this sense is that you have a for a while you get a steady state of enrollments. You know what, how many enrollments you're going to get every given month. So that allows us and gives us confidence as to how we project or forecast 2025.

所以這非常強大。因此，我們對此非常有信心，正如 Rich 提到的我們對該產品的經驗以及我們所看到的，這通常是罕見疾病產品的特點，從這個意義上講，您會在一段時間內獲得穩定的註冊狀態。您知道每個月會招收多少名學生嗎？這讓我們對 2025 年的預測充滿信心。

Is that helpful, Charles?

這有幫助嗎，查爾斯？

Yeah, it is helpful, and I had just one follow-up, and this is more of a strategy question with regard to the deployment of cash. You're building cash nicely in the last year, and I guess I'm thinking about FICOMPA and perhaps revenue being reduced in 206. Is it your plan to try to replace that revenue with another?

是的，這很有幫助，我只想問一個後續問題，這更像是一個關於現金部署的策略問題。您去年的現金累積很不錯，但我想，FICOMPA 和 206 年的收入可能會減少。你的計劃是嘗試用其他收入來取代這部分收入嗎？

Effort in epilepsy or are you not so concerned about epilepsy specifically and investing further in that, but what would you like to do in terms of FICOMPA [revs] in 206? Thanks.

您是在癲癇方面所做的努力，還是您並不特別關心癲癇，也沒有在該領域進一步投入，但是您想在 206 年的 FICOMPA [revs] 方面做些什麼？謝謝。

So from a business development standpoint, we remain open to orphan and differentiated products that we think can make a difference for patients. If it's epilepsy, we we stand behind the FICOMPA acquisition as something that helped us build our war chest, if you will, but we want to stay in the orphan space. Retail is not a place we want to spend a lot more time in the future. If it's epilepsy and it's orphan, we would be interested in that, but we have a very wide aperture for acquisitions or partnerships for products.

因此，從業務發展的角度來看，我們仍然對那些我們認為可以為患者帶來改變的孤兒產品和差異化產品持開放態度。如果是癲癇病，我們支持收購 FICOMPA，因為這幫助我們累積了資金，但我們希望繼續留在孤兒藥領域。未來我們不想在零售業上花太多時間。如果是癲癇症並且是孤兒病，我們會對此感興趣，但我們在產品收購或合作方面有非常廣泛的選擇。

It's helpful. Thank you.

這很有幫助。謝謝。

Thank you.

謝謝。

Thank you. Our next question comes from the line of Jason G Gerberry with Bank of America. Please proceed with your question.

謝謝。我們的下一個問題來自美國銀行的 Jason G Gerberry。請繼續回答您的問題。

Hey guys, this is Bobbin on for Jason. Congrats on the quarter. First question, I wanted to ask you guys what the new indication that you're pursuing with the Agamri is, which we noted on the PR. And then the second question may be on M&A, is the company looking at gene therapy, which has proven challenging for others in biopharma. And just wanted to get your thoughts on, continued efforts towards revenue diversification. Thank you.

嘿夥計們，這是 Jason 的 Bobbin。恭喜本季取得佳績。第一個問題，我想問你們，你們對 Agamri 所追求的新適應症是什麼，我們在公關中提到了這一點。第二個問題可能是關於併購，該公司是否正在考慮基因療法，這對其他生物製藥公司來說是一個挑戰。只是想聽聽你對繼續努力實現收入多元化的看法。謝謝。

Well thanks for the question. Regarding the new indications, so in the 10K we did speak to some of the work that we're doing to further classify how we might go forward with Agamri. I'll turn that over to Gary, our Chief Medical Officer. Gary, do you want to address the work that we're doing there?

嗯，謝謝你的提問。關於新的適應症，在 10K 中我們確實談到了我們正在進行的一些工作，以進一步確定我們如何推進 Agamri 的進展。我將把這個任務交給我們的首席醫療官加里 (Gary)。加里，你想談談我們在那裡所做的工作嗎？

Sure, thank you. Yes, of course our focus has been on the successful launch of Agamri , and we continue to look at rare diseases which can benefit from a unique corticosteroid in that. And in terms of that, we're further characterizing Agamri in terms of its ability to provide immunosuppression. And look at the characteristics of the product that will allow us to better assess it for all the potential possibilities in the rare disease space.

當然，謝謝。是的，我們的重點當然是成功推出 Agamri，我們將繼續研究可以從獨特的皮質類固醇中受益的罕見疾病。就這一點而言，我們將進一步根據 Agamri 提供免疫抑制的能力對其進行描述。透過查看產品的特性，我們可以更好地評估其在罕見疾病領域的所有潛在可能性。

And to your question about gene therapy, obviously when we look at the opportunity within the orphan space, we see the vast majority of orphan conditions have a gene component. So this is something we track very closely. We think about it in very similar ways that we think about our other opportunities, non-gene therapy opportunities. However, we look at it with a little bit.

關於基因治療的問題，顯然，當我們研究孤兒病領域內的機會時，我們會發現絕大多數孤兒病都與基因有關。因此，這是我們密切關注的事情。我們對此的思考方式與我們對其他機會、非基因治療機會的思考方式非常相似。然而，我們稍微看一下它。

Maybe a little bit more closely in a couple of components. Obviously the opportunity has to be close to market. It has to be immediately creative or nearly immediately creative. The CMC has to be very clean because we think this is incredibly challenging. I think you all know I come from a cell therapy background, obviously different from gene, but closely aligned on the CMC component. So we look at that, we really want to be sure that we truly understand the CMC component of it, and there has to be a clear need.

可能在某些組件上更加接近。顯然，機會必須貼近市場。它必須是立即有創意的或幾乎立即有創意的。CMC 必須非常乾淨，因為我們認為這極具挑戰性。我想你們都知道我來自細胞治療領域，顯然與基因治療不同，但在 CMC 成分上密切相關。因此，我們看一下，我們確實想確保我們真正理解它的 CMC 元件，並且必須有明確的需求。

We've seen the uptake of gene therapy products be incredibly challenged, so we really want to understand the different differentiated nature of the product with the therapy, and we want to understand what's going on in the market space. So we would consider it. However, we want to be really careful in understanding how the product might perform given the performance of past gene therapy products. Is that helpful?

我們看到基因療法產品的普及面臨著巨大的挑戰，因此我們確實想了解產品與療法的不同差異化性質，並且我們想了解市場領域的現狀。所以我們會考慮。然而，我們希望非常謹慎地了解該產品的表現，以及過去基因療法產品的表現。這樣有幫助嗎？

Yes, that was great. Thank you guys. I really appreciate the help. Sure.

是的，非常棒。謝謝你們。我非常感謝你的幫助。當然。

Thank you. Our next question comes in the mind of June Lee with Druid Securities. Please proceed with your question.

謝謝。我們的下一個問題來自 Druid Securities 的 June Lee。請繼續回答您的問題。

Congrats on the quarter and thanks for taking the questions. This is Asim Ranul on for June Lee. Just a question on the gross net. So you mentioned the gross net changed for FirdApps in 2025. How much of a change should we expect from '24, and then, what proportion of FirdApps patients are currently on the 100 mg dose? Thank you.

恭喜本季取得的成績，並感謝您回答問題。這是 June Lee 的 Asim Ranul。我只想問一下關於總淨值的問題。所以您提到了 FirdApps 2025 年的總淨收入發生了變化。我們應該預期 24 年會發生多大的變化，然後，目前有多少比例的 FirdApps 患者服用 100 毫克劑量？謝謝。

Thanks. First question we'll turn over to Mike, and then the second question we'll turn over to Jeff. Mike, do you want to take that one? Sure.

謝謝。第一個問題我們將交給麥克，第二個問題我們將交給傑夫。麥克，你想拿那個嗎？當然。

Thanks. 2024, we saw a very small impact from the IRA, less than 1% if you look at the gross net. We're thinking that based on the book of business that could be in the 3% to 3.5% range for 2025 and we'll continue to increase as a reminder we're under the small manufacturers, so there's a phased in approach.

謝謝。 2024 年，我們看到 IRA 的影響非常小，如果從總淨值來看，影響不到 1%。我們認為，根據業務情況，到 2025 年，該比例可能會在 3% 到 3.5% 之間，我們還將繼續增加，提醒我們，我們屬於小型製造商，因此需要分階段實施。

Over years, right

多年來，對吧

over the coming years, yes.

是的，在未來幾年。

And I'll answer the question about the dosing. What I can give you right now is our average daily dose has increased. We saw since the label expansion in June.

我將回答有關劑量的問題。我現在能告訴你的是，我們的平均每日劑量已經增加了。自六月以來我們就看到了標籤擴充。

The average daily dose increased about 2 mg, and we have forecasted for 2025 because of the increased availability or flexibility to physicians to optimize treatment for these patients, an additional 2 mg built in to the forecast for that. At this time also, there are about 20% of our patients that are at about 100 mg.

平均每日劑量增加約 2 毫克，我們預測到 2025 年，由於醫生為這些患者優化治療提供了更多的可用性或靈活性，因此在預測中將額外增加 2 毫克。目前，我們約有 20% 的患者劑量約為 100 毫克。

Thank you.

謝謝。

Thank you. Our next question comes from the line of Samantha Simcoe with Citi. Please proceed with your question.

謝謝。我們的下一個問題來自花旗銀行的 Samantha Simcoe。請繼續回答您的問題。

Hello, this is Benjamin Pellu for Sam. Thanks for taking our questions. Maybe starting with the Agamri, can you speak to the factors that you expect to drive demand for in 2025 and that support your 2025 guidance of $100 million to $110 million? How should we think about the cadence of the launch throughout the year?

大家好，我是 Sam 的 Benjamin Pellu。感謝您回答我們的問題。也許從阿加姆裡 (Agamri) 開始，您能談談您預計在 2025 年推動需求的因素以及支持您在 2025 年實現 1 億至 1.1 億美元目標的因素嗎？我們應該如何考慮全年發布的節奏？

Thanks, Benjamin. I'll turn it over to Jeff for the demand question.

謝謝，本傑明。我將把需求問題交給傑夫。

Thanks for the question. And regarding Agamri, we mentioned the percent mix of the transition, so the boys living with DND 44% coming from the prednisone segment, and about 43% coming from [M plaza], and that gives us extreme confidence in the continued growth because we're seeing transitions across both segments.

謝謝你的提問。關於 Agamri，我們提到了轉變的百分比組合，因此患有 DND 的男孩中 44% 來自潑尼松細分市場，約 43% 來自 [M plaza]，這讓我們對持續成長充滿信心，因為我們看到了兩個細分市場的轉變。

Initially when we launched, we expected more of our transitions to come from [NFplaza] for a variety of reasons. So having that gives again gives us confidence. We continue to expect transitions from both segments moving forward at a steady pace. I did mention the the competitive landscape that we're seeing. So, what we expect is over time over this year we'll see some of that effect of the queuing effect that I mentioned will be playing itself through so probably in the middle of the year and we'll start seeing more acceleration in enrollments, which is built into the forecast that we provided. Does that help at all?

最初當我們推出時，由於各種原因，我們預計更多的轉變來自 [NFplaza]。因此，這項舉措再次給了我們信心。我們繼續期待兩個部門的轉型能夠穩步推進。我確實提到了我們所看到的競爭格局。因此，我們預計，隨著時間的推移，今年我們將看到我提到的排隊效應的部分影響將逐漸顯現，所以很可能在年中，我們將開始看到入學人數加速成長，這已經包含在我們提供的預測中。這樣有幫助嗎？

Yeah, that's helpful.

是的，這很有幫助。

Thank you so much. And then maybe, moving over to FirdApps, can you speak to your expectations for revenue contribution from small cell lung cancer patients over 2025? How much growth are you expecting from this segment over the next several quarters?

太感謝了。然後也許，請到 FirdApps，您能談談您對 2025 年小細胞肺癌患者收入貢獻的預期嗎？您預計未來幾季該部門將實現多少成長？

Yeah, Jeff will take that one as well. At this time.

是的，傑夫也會接受這個。此時。

We see about 20% of our revenue or our patients are from the small cell lung cancer lens or cancer associated limbs segment. And we expect in 25 to really focus on initiating or getting screening programs implemented. So it's really about helping those 90% of undiagnosed small cell lung cancer lens patients get diagnosed. So that's where our focus. So as far as contributions this year are growth from the small cell lung cancer lens segment, it's going to be very minimal in 2025, but we expect that to grow in our years.

我們發現大約 20% 的收入或患者來自小細胞肺癌水晶體或癌症相關肢體部分。我們預計在 25 年內將真正專注於啟動或實施篩檢計畫。因此，這實際上是為了幫助 90% 未確診的小細胞肺癌晶狀體患者得到診斷。這就是我們的重點。因此，就今年來自小細胞肺癌晶狀體領域的成長貢獻而言，到 2025 年這一數字將非常小，但我們預計在未來幾年內將會成長。

Yes, so I'll just add to that. We've done we've had a really thoughtful approach here in developing the KOL community around this in academic institutions. Jeff and the team have done a really good job making sure we will work. We work closely with the KOLs to get the opportunity for understanding of how this.

是的，我只想補充一點。我們已經採取了非常周到的方法來在學術機構中發展 KOL 社區。傑夫和他的團隊做得非常出色，確保了我們能夠順利工作。我們與 KOL 密切合作以獲得了解這一情況的機會。

Would work and now pivoting that effort now to the community where as Jeff said, the majority, the vast majority of small cell lung cancer is treated. The KOLs are in position. I think our messaging is in position and so we can pivot now and begin to work with those physicians in the community. So we're really excited about this opportunity.

會起作用，現在將努力轉向社區，正如傑夫所說，大多數、絕大多數小細胞肺癌都得到了治療。KOL已到位。我認為我們的訊息傳遞已經到位，因此我們現在可以轉變方向並開始與社區中的醫生合作。所以我們對這個機會感到非常興奮。

Great, thank you so much.

太好了，非常感謝。

Thank you. Our next question comes from the line of Joe Kansasaro with Piper Sandler. Please proceed with your question.

謝謝。我們的下一個問題來自派珀·桑德勒 (Piper Sandler) 的喬·堪薩薩羅 (Joe Kansasaro)。請繼續回答您的問題。

Great. Hey everybody, thanks for taking my questions. Maybe first one following up on those recent comments you made, Jeff, on the queuing effect you're seeing in DMD. Wondering if you could elaborate a little bit more on what you mean by the queuing effect and anything you guys can do to shorten the time a patient spends in that queue and maybe somewhat relatedly what you've seen or heard that has sort of led you to make the decision to separate the sales force. FirdApps and Agamri later this year. Thanks and I have maybe a quick follow up.

偉大的。大家好，謝謝你們回答我的問題。傑夫，也許這是你最近發表的關於 DMD 中看到的排隊效應的評論的第一個跟進。想知道您是否可以更詳細地解釋一下排隊效應的含義，以及您可以做些什麼來縮短患者在排隊中花費的時間，也許在某種程度上與您看到或聽到的情況有關，這促使您做出分離銷售團隊的決定。FirdApps 和 Agamri 將於今年稍後上市。謝謝，我可能會快速跟進。

Sure, thanks for the question. And first thing is a competitive landscape within the [Duchenne] space is a great thing for the patients and we want to acknowledge that. In June of last year, Elebius, as had an expansion of their label, so that allowed for boys four years of age and older, regardless of ambulatory status to be eligible or considered for a Leviduss treatment.

當然，謝謝你的提問。首先，我們希望承認杜氏肌肉營養不良症領域的競爭格局對患者來說是件好事。去年 6 月，Elebius 擴大了其標籤範圍，允許 4 歲及以上的男孩，無論是否能夠行走，都有資格或考慮接受 Leviduss 治療。

When that happened, a lot of patients and their families and healthcare providers wanted to see if they could be evaluated or are they a fit for a Levious treatment. So this is just an example. So when that happens, these patients in this treatment team, they do not want to change their treatment.

當這種情況發生時，許多患者、他們的家人和醫療保健提供者都想看看他們是否可以接受評估或是否適合接受 Levious 治療。這只是一個例子。因此當這種情況發生時，這個治療團隊中的這些患者不想改變他們的治療方法。

Their steroids, if they're on prednisone, they stay on prednisone until they're evaluated and either treated or decided that it's not the right fit for them. If they are treated, then typically what they'll do is they'll wait about 60 days post a Levi's treatment before they will consider switching their their steroid.

他們的類固醇藥物（如果正在服用潑尼松）會一直服用，直到經過評估並接受治療或決定該藥物不適合他們為止。如果他們接受治療，那麼通常他們會在 Levi's 治療後等待大約 60 天，然後才會考慮更換類固醇。

So it's that type of queuing effect. It's not just those patients that are on a new product. It's as they're being evaluated for treatment on any of these new products. So that's why it may delay, just delay the initiation of a Agamri. But this happened in June and we've seen it playing through and we expect it to work its way through probably by the middle of this year. So we don't anticipate this being a long term challenge for Agamri. We just see it as a slight delay for initiation to a Agamri for some patients.

這就是那種排隊效應。不只是那些患者在使用新產品。就像他們正在接受針對任何新產品的治療效果的評估一樣。所以這就是為什麼它可能會延遲，只是延遲 Agamri 的啟動。但這件事在六月就發生了，我們已經看到它的進展，我們預計它可能會在今年年中得到解決。因此我們預計這對阿加姆裡來說不會是一個長期挑戰。我們只是認為對於某些患者來說，開始使用 Agamri 藥物會稍微延遲。

Is that helpful, Joe?

這樣有幫助嗎，喬？

Yeah, that's helpful. Maybe my follow up on FICOMPA. I know historically you guys have said that, the epilepsy market could be resilient to generics. I'm wondering if your your guidance for 2025 factors some of that resiliency in, and I think you alluded to this a little bit, but any new efforts that you'll employ to maybe slow that that erosion trajectory. Thanks.

是的，這很有幫助。也許是我對 FICOMPA 的後續行動。我知道你們過去曾說過，癲癇市場可能對仿製藥具有抵禦能力。我想知道您對 2025 年的指導是否考慮到了其中的一些彈性，我想您稍微提到了這一點，但您採取的任何新舉措都可能減緩這種侵蝕軌跡。謝謝。

So we see the resiliency there. Obviously we have the opportunity to sell the products under the patent through the end of May on the solid dose and then the suspension through the end of November. So we're excited about that and we'll continue to make those efforts.

所以我們看到了那裡的彈性。顯然，我們有機會在 5 月底之前以固體劑量的形式銷售專利產品，然後在 11 月底之前暫停銷售。我們對此感到非常興奮，並將繼續努力。

The resiliency is there in the fact that there's that stickiness that we continually talk about. However, once the generics come on the market.

事實上，我們不斷談論的黏性就體現出了彈性。然而，一旦仿製藥上市。

We will see price erosion and volume erosion, so we expect to have that opportunity to continue to work with the payers, and we are working with the payers right now to continue to get favorable position in the marketplace and hold it. We do expect the patients to want the brand, a significant portion of them want the brand and the payers to want to work with us to hold that favorable position. So unlike traditional products, traditional retail products that lose the majority of their volume in eight weeks post patent spree, we expect to hold on to a considerable amount of our volume throughout the year.

我們將看到價格和銷售量的下降，因此我們希望有機會繼續與付款人合作，我們現在正在與付款人合作，以繼續在市場上獲得有利地位並保持下去。我們確實希望患者想要這個品牌，他們中的很大一部分想要這個品牌，而付款人希望與我們合作以保持這一有利地位。因此，與傳統產品不同，傳統零售產品在專利熱潮過後的八週內就會失去大部分銷量，而我們預計全年仍能保持相當一部分銷量。

And I wanted to respond. I forgot to Joe, I forgot to respond to your message about splitting up the sales force. So what we're doing by having a dedicated sales force, it's allowing us more of a focused approach. I I mentioned earlier the really crowded competitive landscape for Duchenne specifically. And when you look at that. A dedicated sales force for a Agamri will allow us to optimize engagement with the treating HCP team so that team across any center of excellence and support the continued growth.

我想做出回應。我忘了喬，我忘了回覆你關於拆分銷售隊伍的消息。因此，我們透過擁有一支專門的銷售隊伍，讓我們能夠採取更集中的方法。我之前提到過，杜氏肌肉營養不良症的競爭環境確實非常激烈。當你看到它的時候。Agamri 的專業銷售團隊將使我們能夠優化與治療 HCP 團隊的合作，以便任何卓越中心的團隊能夠支持持續成長。

So that's why we made that decision. Now also for FirdApps, when you evaluate the lens opportunity with FirdApps, we've talked about this. We We see significant opportunity for organic growth into the future and by allowing this dedicated or special specialized approach for a Agamri or for FirdApps also that will allow us for those deeper relationships to help find these patients and help these patients get diagnosed and transition to treatment.

這就是我們做出這個決定的原因。現在對於 FirdApps，當您評估使用 FirdApps 的鏡頭機會時，我們已經討論過這一點。我們看到了未來有機成長的巨大機會，透過為 Agamri 或 FirdApps 提供這種專用或特殊的專業方法，我們也將建立更深層的關係，以幫助找到這些患者，幫助這些患者得到診斷並過渡到治療。

Great, thank you. Appreciate you circling back on that. Thanks for taking my questions.

太好了，謝謝。感謝您再次討論此問題。感謝您回答我的問題。

Thanks Joe.

謝謝喬。

Thank you. Our next question comes from the line of Joel Beattie with Bayer. Please proceed with your question.

謝謝。我們的下一個問題來自拜耳公司的喬爾·比蒂。請繼續回答您的問題。

Hi, thanks for taking the questions. The first one is related to a Agamri in a competitive DMD marketplace. What are you seeing in terms of the generic erosion for [MFplaza] and how much could that impact the opportunity for Agamri to grow?

嗨，感謝您回答這些問題。第一個與競爭激烈的 DMD 市場中的 Agamri 有關。您認為 [MFplaza] 的普遍侵蝕情況如何？這對 Agamri 的成長機會有多大影響？

Thanks for your question. We have not seen much generic entrant into this or conversion from and branded and Plaza at this point from what we've seen, we haven't seen much, and we don't see that impacting a Agamri, and we have not really factored that into or made assumptions based on that into our forecast for a Agamri in 2025. We haven't seen any changes to payers and how they've reacted to Agamri because of generic implaza, so that that's what gives us confidence that we have minimal impact to a Agamri in 2025.

感謝您的提問。從目前的情況來看，我們還沒有看到太多普通企業進入這一領域，也沒有看到太多品牌和廣場的轉變，我們認為這不會對阿加姆裡產生影響，我們也沒有真正考慮到這一點，也沒有在對 2025 年阿加姆裡進行預測時做出基於此的假設。我們尚未看到付款人發生任何變化，也沒有看到他們對 Agamri 的反應因為仿製藥的衝擊而發生變化，因此我們有信心，我們對 2025 年 Agamri 的影響微乎其微。

So Joel, remember [implasa] has been on the market for a couple of years. Patients, if they're doing step therapy, if they've tried prednisone, they've tried branded [emplaza], making them step back to a generic [inflaza]. Not likely to happen. So right now and for the foreseeable future with the steadiness of the patient population.

所以喬爾，記住 [implasa] 已經上市幾年了。如果患者正在接受分步治療，如果他們嘗試過潑尼松，他們也嘗試過品牌藥物（emplaza），那麼他們就會回到通用藥物[發炎]。不太可能發生。因此，目前以及可預見的未來患者人數將保持穩定。

It's not likely to happen, not likely to have a large effect on on the ability to take that patient who's already been on prednisone or a version of M plaza. It's just not likely to happen at this time and again for the foreseeable future. Does that make sense?

這不太可能發生，也不太可能對已經服用潑尼鬆或 M plaza 的患者產生很大的影響。在可預見的未來，這種情況不太可能再次發生。這樣有道理嗎？

Yeah, that does make sense. Thank you. And then maybe one last question related to SGNA in 2025 in the prepared remarks you mentioned an increase this coming year. Could you quantify that at all?

是的，這確實有道理。謝謝。然後也許最後一個問題與 2025 年 SGNA 有關，在準備好的演講中您提到了今年將會增加。您能量化這一點嗎？

Oh, thanks. We haven't quantified, if you recall, we did not quantify last year either, are expecting the increase as we laid out and we'll give a little bit more clarity as the year progresses, in part, how long does it take to fill up the positions, etc.

哦，謝謝。我們還沒有量化，如果你還記得的話，去年我們也沒有量化，我們預計會有成長，隨著時間的推移，我們會給出更清晰的信息，例如需要多長時間才能填補這些職位，等等。

Makes sense. Thank you.

有道理。謝謝。

Thank you.

謝謝。

Thank you.

謝謝。

Our next question comes to the line of Levin Dershowitz with Oppenheimer. Please proceed with your question.

我們的下一個問題來自奧本海默的萊文·德肖維茨。請繼續回答您的問題。

[Hey Leeland. Hey, this] is Rowan on for Leland. Thanks for your question. [How are you doing?] Good. How are you? Just a couple questions for me. Now that we have greater clarity on the FirdApps IP protections moving forward, how does that shape further investment into the franchise and also how do you think about the extended commercial runway and how it changes the approach to business development when evaluating different size and structured deals.

[嘿，Leeland。嘿，這是羅文 (Rowan) 代替利蘭 (Leland) 上場。感謝您的提問。[你好嗎？ ] 很好。你好嗎？我只想問幾個問題。現在我們對 FirdApps 的智慧財產權保護有了更清晰的認識，這將如何影響對特許經營的進一步投資，您如何看待延長的商業運行時間，以及在評估不同規模和結構化交易時，它如何改變業務發展方式。

Great question. Thank you for the questions.

好問題。感謝您的提問。

So remember there are still two other litigants out there, right? So we're still working to defend the entire estate, and we want to be sure that we're doing that. But the question is a really good one. As we look at the opportunity, should we end up with a full 10 year opportunity?

所以請記住，還有另外兩名訴訟當事人，對嗎？因此，我們仍在努力保衛整個莊園，並且我們希望確保我們正在做到這一點。但這個問題確實很好。當我們審視這個機會時，我們是否應該獲得整整 10 年的機會？

We would look at it as if it's a brand that's going to be on the market for 10 years and you would continue to look and seek opportunities to invest. And as we talked about with an earlier question, you can see us working a bit more aggressively on the oncology side because if there's an opportunity to build that part of the business, which is about 50% of the business, we will continue to do that.

我們會將其視為一個將在市場上銷售 10 年的品牌，並將繼續尋找並尋求投資機會。正如我們之前在回答問題時提到的，您可以看到我們在腫瘤學方面做得更積極一些，因為如果有機會發展這部分業務（約佔業務的 50%），我們將繼續這樣做。

We want we may go back and look at some other research opportunities as well. There may be opportunities there. We have to fully vet those opportunities as well, but we'll continue to look at the opportunities and see if there's a way to continue to build a business.

我們希望我們可以回顧並看看其他一些研究機會。那裡可能有機會。我們也必須充分審查這些機會，但我們會繼續尋找機會，看看是否有辦法繼續發展業務。

Life cycle management has many forms. It could be through research, it could or development of a product, I should say, or it could be through, further commercialization efforts as well. So we're going to consider all avenues to fully optimize the value of the asset.

生命週期管理有多種形式。這可以透過研究來實現，或者我應該說，可以透過開發產品來實現，或者也可以透過進一步的商業化努力來實現。因此，我們將考慮所有途徑來充分優化資產價值。

Got it. And we saw that the guidance for FICOMPA reflects some expectations of possible generic erosion. I mean, in patients in the states tend to see greater brand adherence than in others, and can you speak about maybe what you're seeing commercially that is driving the lower guidance?

知道了。我們看到，FICOMPA 的指導反映了對仿製藥可能受到侵蝕的一些預期。我的意思是，美國的患者比其他地區的患者對品牌的依從性更高，您能否談談從商業角度來看是什麼導致了較低的指導價格？

So what will happen, so we'll drive the lower guidance is we'll be able to maintain the trend that we're on. The product is my standard comment is it's like the mailman, it delivers. It just keeps delivering. It'll deliver through the end of May.

那麼會發生什麼事呢？因此，我們將降低指導價，以便能夠維持我們所處的趨勢。我對產品的標準評價是，它就像郵差一樣，可以送貨。它只是持續不斷地傳遞訊息。將於五月底交付。

Should a generic come on the market in June, it'll be fine, but Once it goes off pat, some patients are price sensitive. That's the nature of patients. Some patients are brand sensitive. They'll want to maintain, and that's especially true in the generic, I'm sorry, in the epilepsy market.

如果仿製藥在六月上市，那就沒問題，但一旦仿製藥上市，有些患者就會對價格很敏感。這就是病人的本質。有些患者對品牌很敏感。他們想要維持，尤其是在仿製藥，對不起，在癲癇藥市場中尤其如此。

There will be some contracting we'll do with payers to to maintain our position. That will be an erosion of price and we will lose some volume, so there'll be a mix of price and volume. But as I said in response to an earlier question, It will be much more sustainable than you would see with a typical retail product. That is the nature of epilepsy products. So that's our expectation at this point in time, and we will continue to give updated guidance as the market evolves.

我們將與付款人簽訂一些合約來維持我們的地位。這會導致價格下跌，我們也會損失一些銷量，所以會出現價格和銷量參差不齊的情況。但正如我在回答之前的問題時所說的那樣，它將比典型的零售產品更具可持續性。這就是癲癇產品的本質。這是我們目前的預期，我們將隨著市場的發展繼續提供更新的指導。

Thank you. Congrats on another great quarter.

謝謝。恭喜您又度過了一個出色的季度。

Oh thanks, thank you.

哦，謝謝，謝謝。

Thank you. Our next question comes from a line of Sudan Logan [Undone] with Steven. Please proceed with your question.

謝謝。我們的下一個問題來自蘇丹洛根（Sudan Logan）[Undone] 和史蒂文 (Steven) 的提問。請繼續回答您的問題。

Congrats on the call. This is Felix. I'm from for Sudan Logan [Undone]. I have two questions, one on FirdApps. Given the fact that the product has done very well in the marketplace, how well have you penetrated the lens market? If you can give color on the percent, that would be very helpful. And then one other question is on the Summit trail for Agamri.

恭喜你接通了電話。這是菲利克斯。我來自蘇丹 Logan[未完成]。我有兩個問題，一個是關於 FirdApps 的。鑑於該產品在市場上表現非常好，您在鏡頭市場的滲透程度如何？如果您能給出百分比的顏色，那將會非常有幫助。還有一個問題是關於阿加姆裡的登頂之路。

If you can give us potentially expansion opportunities that you can, it's out there, that would be helpful for us to model the company very well.

如果您能為我們提供潛在的擴張機會，這對我們來說將非常有幫助，可以很好地塑造公司形象。

So, the second part of the question was summit, was it summit? Okay.

那麼，問題的第二部分是峰會，是峰會嗎？好的。

Yeah.

是的。

So in January at JPMorgan we gave a market valuation for lems over and this is I just want to be really clear, this is at today's prices, and a conservative view of the market, assuming there are 3,600 patients in the market and the addressable size of the market, not the total 100% of the market, addressable patients within the market. The market is valued at over a billion dollars.

因此，今年 1 月，摩根大通對 lems 進行了市場估值，我只是想非常清楚地說明，這是按今天的價格計算的，是對市場的保守看法，假設市場上有 3,600 名患者，市場可尋址規模，而不是整個市場的 100%，即市場內可尋址患者。該市場價值超過 10 億美元。

The lens market is valued at over a billion dollars. So to just give a very simple answer, what's our market penetration? Last year we sold $306 million so our market penetration would be about 30%. We believe there's tremendous upside in this market, and given that the settlement with Teva, should we prevail in the other two suits, we have a runway prevail in a similar way with the other two suits. We have a runway of 10 years and we're all alone. So we think there's tremendous upside in this market, and we intend to invest appropriately to see that upside come to fruition.

鏡頭市場價值超過10億美元。那麼，我只想給一個非常簡單的答案，我們的市場滲透率是多少？去年我們的銷售額為 3.06 億美元，因此我們的市場滲透率約為 30%。我們相信這個市場有巨大的上升空間，鑑於與 Teva 達成的和解，如果我們在另外兩起訴訟中獲勝，那麼我們將以類似的方式在另外兩起訴訟中獲勝。我們的跑道有 10 年了，但我們都是孤身一人。因此，我們認為這個市場具有巨大的上升空間，並且我們打算進行適當的投資，以實現這個上升空間。

On summit, we intend to use the summit study to see if we can make it clarify the differentiation of Agamri from other steroids in the market. We believe it's a unique steroid and we will invest appropriately in that study. Whether or not that can result in a label change, I'll let Gary address that, but there's obviously opportunities to publish, whether it's posters or publications in in journals or not. But Gary, do you want to take the question?

在高峰會上，我們打算利用峰會研究來看看我們是否可以使其明確 Agamri 與市場上其他類固醇的區別。我們相信它是一種獨特的類固醇，我們將對該研究進行適當的投資。這是否會導致標籤改變，我會讓加里來解決這個問題，但顯然有出版的機會，無論是海報還是期刊出版物。但是加里，你想回答這個問題嗎？

Sure, thank you. The, as Rich said, we really are looking to get the long term safety information that we expect to generate with Summit out into the public. The fastest way to do that is through posters, presentations, abstracts, publications. Label expansion depends upon the overall strength and amount of data.

當然，謝謝。正如里奇所說，我們確實希望將我們期望透過 Summit 產生的長期安全資訊公之於眾。最快的方法是透過海報、簡報、摘要和出版物。標籤擴展取決於整體強度和資料量。

We certainly have planned and look forward to the study, but having that potential, the way it is designed. But it will depend upon what we see as we go along. However, I believe that the information to be generated on the different parameters of bone health, growth velocity, cardiac safety, fractures, cataract formation will all be very important data to make available as soon as it is ready. To the prescribing population.

我們確實已經計劃並期待這項研究，但它的設計方式具有這種潛力。但這將取決於我們在前進過程中看到的情況。然而，我相信，一旦準備就緒，有關骨骼健康、生長速度、心臟安全、骨折、白內障形成等不同參數的資訊都將是非常重要的數據。對於開處方的人群。

Thank you. Thank you very much.

謝謝。非常感謝。

Thank you.

謝謝。

Thank you.

謝謝。

We have reached the end of the question and answer session, and this also concludes today's conference.

問答環節到此結束，今天的記者會也結束了。

(Operator Instructions)

（操作員指令）