Catalyst Pharmaceuticals Inc (CPRX) 2025 Q1 法說會逐字稿

Good day everyone and welcome to today's Catalyst Pharmaceuticals1st quarter 2025 financial results conference call.

大家好，歡迎參加今日的 Catalyst Pharmaceuticals 2025 年第一季財務業績電話會議。

(Operator Instructions)

（操作員指示）

It is now my pleasure to turn today's program over to Michael Kalb, CFO. Please begin.

現在我很高興將今天的節目交給財務長 Michael Kalb。請開始。

Good morning, everyone and thank you for joining our conference call to discuss Catalyst's first quarter 2025 financial results and business highlights.

大家早安，感謝您參加我們的電話會議，討論 Catalyst 2025 年第一季的財務表現和業務亮點。

Leading the call today is Richard Daly, Catalyst's President and Chief Executive Officer.

今天主持電話會議的是 Catalyst 總裁兼執行長理查德戴利 (Richard Daly)。

We are also joined by Jeff Del Carmen, our Chief Commercial Officer.

我們的首席商務長 Jeff Del Carmen 也加入了我們。

For further for the Q&A session, Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer, will be available for questions.

在問答環節中，我們的營運長兼首席科學官 Steven Miller 博士將回答您的提問。

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.

在我們開始之前，我想提醒大家，在今天早上的演講和問答環節中，我們將對預期的未來結果做出陳述，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 not prove to be accurate.

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

Actual results may vary from the expectations contained in our forward-looking statements.

實際結果可能與我們的前瞻性陳述中的預期有所不同。

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 recent 2024 annual report on Form 10k filed with the SEC on February 26, 2025.

這些前瞻性陳述應僅與我們向美國證券交易委員會 (SEC) 提交的文件中包含的詳細資訊結合考慮，包括我們於 2025 年 2 月 26 日向美國證券交易委員會提交的最新 2024 年 10k 表格年度報告中所述的風險因素。

And our first quarter, 2025 quarterly report on Form 10Q, which was filed yesterday, May 7, 2025, with the SEC. At this time, I'll turn the call over to Rich. Rich.

我們的 2025 年第一季 10Q 表季度報告已於昨天（2025 年 5 月 7 日）向美國證券交易委員會提交。現在，我將把電話轉給里奇。富有的。

Thanks, Mike. Good morning, everyone, and thanks for joining us.

謝謝，麥克。大家早安，感謝大家的參與。

Catalyst delivered an outstanding start to 2025 with continued excellent execution, strong demand for our rare disease therapies, and continued progress on key strategic priorities.

Catalyst 在 2025 年取得了出色的開局，繼續保持出色的執行力，市場對罕見疾病療法的需求強勁，並且在關鍵戰略重點上繼續取得進展。

These results highlight our sustained momentum and growing impact in the patient communities we serve.

這些結果凸顯了我們在所服務的患者群體中持續的發展勢頭和日益增長的影響力。

Total net revenues grew 43.6% year over year to $141.4 million with meaningful contributions from each of our products.

總淨收入年增 43.6% 至 1.414 億美元，我們的每種產品都做出了有意義的貢獻。

These results highlight the strength of our portfolio and the effectiveness of our commercial execution.

這些結果凸顯了我們產品組合的實力和商業執行的有效性。

With a strong cash position of $580.7 million and disciplined operational management, we are well positioned to drive long-term growth while advancing our strategic priorities.

憑藉 5.807 億美元的強勁現金狀況和嚴謹的營運管理，我們完全有能力推動長期成長，同時推進我們的策略重點。

Let's turn to the specifics of our commercial performance, beginning with FIRDAPSE.

讓我們來看看我們的商業表現的具體情況，從 FIRDAPSE 開始。

FIRDAPSE continues to demonstrate outstanding performance, maintaining its position as the only evidence-based approved product in the US for Lebert-Eaton Myasthenic syndrome or LEMS.

FIRDAPSE 繼續表現出色，保持其作為美國唯一獲得循證批准的治療 Lebert-Eaton 肌無力症候群（LEMS）的產品的地位。

In the first quarter of 2025, the brand delivered another strong quarter of organic growth, generating revenue of $83.7 million an increase of 25.3% year over year.

2025 年第一季度，該品牌再次實現強勁的有機成長，營收達 8,370 萬美元，較去年同期成長 25.3%。

Performance was driven by continued adoption among newly diagnosed patients and a modest tailwind from normalized prescription activity following temporary disruptions related to the changed healthcare cybersecurity incident in Quarter 1 2024.

績效成長的動力來自於新診斷患者的持續採用，以及在 2024 年第一季醫療網路安全事件發生變化導致暫時中斷之後，處方活動恢復正常帶來的適度推動。

The effect of which we expect to level out in Q2 2025. Mike will discuss the impact of James House's cybersecurity incident in more detail in his remarks.

我們預計其影響將在 2025 年第二季趨於穩定。麥克將在演講中更詳細地討論詹姆斯·豪斯網路安全事件的影響。

In addition, since the 100 mg label expansion for FIRDAPSE approved in May 2024, we've seen an increase in the average daily dose of FIRDAPSE.

此外，自 2024 年 5 月批准 FIRDAPSE 100 毫克標籤擴展以來，我們看到 FIRDAPSE 的平均每日劑量有所增加。

The 100 mg enhancement offers providers greater flexibility to individualized therapy based on patient needs. We expect the average daily dose to increase in the near term.

100 毫克的增強劑量為醫療服務提供者提供了更大的靈活性，可以根據患者需求進行個人化治療。我們預計短期內平均每日劑量會增加。

As we have stated in the past, approximately 50% of all LEMS diagnoses are associated with cancer, in particular small cell lung cancer. We continue to work with the National Comprehensive Cancer Network to improve the understanding of the relationship between LEMS and cancer.

正如我們過去所說，大約 50% 的 LEMS 診斷與癌症有關，尤其是小細胞肺癌。我們繼續與國家綜合癌症網絡合作，以加深對 LEMS 與癌症之間關係的理解。

The role of EGCC testing and the benefits of treating LEMS associated cancer patients with FIRDAPSE.

EGCC 測試的作用以及使用 FIRDAPSE 治療 LEMS 相關癌症患者的益處。

These initiatives reflect our strategic approach to extending FIRDAPSE market leadership and positioning the brand for durable long-term growth.

這些舉措體現了我們擴大 FIRDAPSE 市場領導地位和定位品牌實現長期持久成長的策略方針。

This continued performance reinforces our confidence in delivering FIRDAPSE 2025 net product revenue forecast of between $355 million and $360 million.

這一持續表現增強了我們實現 FIRDAPSE 2025 年淨產品收入預測 3.55 億美元至 3.6 億美元的信心。

Now turning to a AGAMREE.

現在轉向 AGAMREE。

AGAMREE delivered a solid performance in Q1 2025, marking its first full year of commercial availability following a March 13, 2024 US launch.

AGAMREE 在 2025 年第一季表現穩健，這是其自 2024 年 3 月 13 日在美國推出以來第一個完整的商業化年份。

Net product revenues totalled $22 million compared with $1.2 million in Q1 2024, reflecting the impact of a full quarter of sales compared to the prior year, sustained organic uptake and increased confidence in the AGAMREE potential as a differentiated corticosteroid treatment for Duchenne's muscular dystrophy, or DMD.

淨產品收入總計 2,200 萬美元，而 2024 年第一季度為 120 萬美元，這反映了與上年相比整個季度的銷售額增長的影響、持續的有機吸收以及對 AGAMREE 作為杜氏肌肉營養不良症 (DMD) 的差異化皮質類固醇治療的潛力的信心增強。

AGAMREE continues to source patients from branded and generic competitors in a balanced manner as it has since launched.

自成立以來，AGAMREE 一直以平衡的方式從品牌藥和仿製藥競爭對手中招募患者。

And the patient retention rate remains robust. We believe these are indications of the market sensing a AGAMREE potential benefits.

患者保留率依然強勁。我們相信，這些表明市場已經感受到 AGAMREE 的潛在利益。

Prescriber engagement continues to build, supported by the full deployment of our dedicated AGAMREE field team in April 2025.

在我們專門的 AGAMREE 現場團隊於 2025 年 4 月全面部署的支持下，處方醫生的參與度不斷提高。

These early commercial indicators position a AGAMREE for broader market reach as a foundational complementary corticosteroid therapy within the evolving DMD treatment landscape.

這些早期的商業指標使 AGAMREE 成為不斷發展的 DMD 治療領域中的基礎補充皮質類固醇療法，從而涵蓋更廣泛的市場。

This momentum continues to support our full year 2025 net revenue forecast for a AGAMREE of between $100 million and $110 million. On the clinical front, we're advancing the summit study, our 5-year real world evidence-based study evaluating long term outcomes in DMD patients treated with a AGAMREE.

這一勢頭繼續支持我們對 2025 年全年 AGAMREE 淨收入的預測，即 1 億美元至 1.1 億美元之間。在臨床方面，我們正在推動高峰會研究，這是我們為期 5 年的真實世界實證研究，評估接受 AGAMREE 治療的 DMD 患者的長期結果。

During the first quarter of 2025, the summit study advanced with the activation of additional sites and continued progress in patient enrolment. We hope that the results of the summit study will provide long term real world evidence of the benefits of the treatment of the AGAMREE.

2025 年第一季度，高峰會研究隨著更多站點的啟動和患者招募的持續進展而取得進展。我們希望高峰會研究的結果能為 AGAMREE 治療的益處提供長期的現實世界證據。

And finally, FYCOMPA.

最後是FYCOMPA。

FYCOMPA delivered solid results in this quarter, driven by steady demand and disciplined execution to maximize near-term value ahead of the anticipated generic entry on or after May 23, 2025.

FYCOMPA 本季度取得了穩健的業績，這得益於穩定的需求和嚴格的執行，旨在在 2025 年 5 月 23 日或之後預計的仿製藥上市之前實現近期價值最大化。

Net product revenue for the period was $35.6 million representing a year over year growth of 17.1% driven by sustained performance.

本期間淨產品收入為 3,560 萬美元，受持續業績的推動，年增 17.1%。

Strong patient preference, and the product's well established clinical role in seizure control.

患者強烈偏好，且該產品在癲癇控制方面具有良好的臨床作用。

As we approach the end of exclusivity, we remain focused on ensuring continuity of care and managing the brand's value through well planned transition.

隨著獨家經營期即將結束，我們仍將專注於確保護理的連續性，並透過精心策劃的過渡來管理品牌價值。

As discussed previously, we expect a measured revenue decline post patent expiry.

如前所述，我們預計專利到期後收入將出現一定程度的下降。

Our teams are fully prepared and executing against a defined strategy to manage this evolution effectively.

我們的團隊已做好充分準備，並按照既定策略執行，以有效地管理這一演變。

We believe that FYCOMPA remains on track to deliver on our 2025 full year net product revenue forecast of between $90.95 million dollars as we continue to maximize near-term value.

我們相信，隨著我們繼續最大化近期價值，FYCOMPA 仍有望實現我們對 2025 年全年淨產品收入 9,095 萬美元的預測。

In parallel, we remain committed to expanding access to our rare disease therapies in markets outside the US. In January, our sub licensee Daidopharma successfully launched FIRDAPSE in Japan, making it the first approved treatment for LEMS.

同時，我們仍致力於擴大美國以外市場對罕見疾病療法的覆蓋範圍。今年 1 月，我們的分證持有者 Daidopharma 在日本成功推出了 FIRDAPSE，使其成為首個獲準的 LEMS 治療藥物。

This important milestone expands access for an estimated 1,200 LEMS patients and addresses an important unmet need in the Japanese rare disease patient community.

這一重要里程碑擴大了約 1,200 名 LEMS 患者的治療機會，並解決了日本罕見疾病患者群體中一個重要的未滿足需求。

In Canada, our sub licensee, Kai Pharmaceuticals, which also markets furs in Canada, is advancing regulatory plans for AGAMREE.

在加拿大，我們的分證持有者 Kai Pharmaceuticals 也在加拿大銷售毛皮，目前正在推動 AGAMREE 的監管計畫。

In April of 2025, Health Canada accepted the new drug submission under priority review.

2025年4月，加拿大衛生部接受了該新藥的優先審查申請。

With potential of approval by year end.

有可能在年底前獲得批准。

If approved, a AGAMREE would be the first authorized treatment for DMD in Canada, addressing a patient population of more than 800 individuals and making a meaningful advancement in care of this underserved DMD community.

如果獲得批准，AGAMREE 將成為加拿大首個獲得授權的 DMD 治療方法，可惠及 800 多名患者，並為這一醫療資源匱乏的 DMD 群體的護理帶來重大進步。

While these license agreements are not expected to contribute materially to revenue, they are aligned with our broader mission to advance health equity by expanding access to our therapies for underserved patient populations.

雖然這些許可協議預計不會對收入產生實質貢獻，但它們符合我們更廣泛的使命，即透過擴大醫療資源不足的患者群體獲得我們的治療的機會來促進健康公平。

Continue to take strategic action to safeguard the long term value of the FAs franchise.

繼續採取策略行動來維護 FA 特許經營權的長期價值。

In January, we reached a favorable settlement with Teva restricting US generic entry until February 25, 2035, subject to certain conditions.

今年 1 月，我們與 Teva 達成了一項有利的協議，限制仿製藥進入美國市場的時間截止到 2035 年 2 月 25 日，但須遵守某些條件。

Litigation with the two remaining first remains ongoing, and we remain confident in our strength, the strength of our intellectual property portfolio.

與剩餘兩家公司的訴訟仍在進行中，我們對我們的實力、我們的智慧財產權組合的實力仍然充滿信心。

However, there could be no assurances that we will prevail in this litigation.

然而，我們無法保證在這場訴訟中獲勝。

Business development continues to be a core growth lever for Catalyst. We remain disciplined in our approach, prioritizing opportunities with strategic synergy, clinical differentiation, and the potential to drive long-term value.

業務發展持續成為 Catalyst 的核心成長槓桿。我們始終堅持嚴謹的方法，優先考慮具有策略協同、臨床差異化和推動長期價值潛力的機會。

With a robust pipeline of evaluations underway, we believe that we are well positioned to execute transactions that further enhance our leadership in rare disease.

隨著一系列強有力的評估正在進行，我們相信我們已做好準備，執行進一步增強我們在罕見疾病領域領導地位的交易。

As we advance through 2025, we remain firmly focused on executing our strategic priorities and sustaining operational excellence with a strong foundation, a high performing team, and a clear path to value creation.

隨著我們邁向 2025 年，我們將繼續堅定地專注於執行我們的策略重點，並透過強大的基礎、高效的團隊和清晰的價值創造路徑保持卓越的營運。

We believe that we are well positioned to deliver durable growth while continuing to elevate care for patients living with rare diseases.

我們相信，我們有能力實現持久增長，同時繼續提高對罕見疾病患者的照護。

We are reaffirming our full year total product revenue guidance of between $545 million to $565 million.

我們重申全年總產品收入預期在 5.45 億美元至 5.65 億美元之間。

We believe Catalyst is well positioned to create a meaningful value for patients, healthcare providers, and our stakeholders.

我們相信 Catalyst 有能力為病患、醫療保健提供者和我們的利害關係人創造有意義的價值。

With that, I'll now turn the call up to Jeffrey Del Carmen, our Chief Commercial Officer.

說完這些，我現在將電話轉給我們的商務長 Jeffrey Del Carmen。

Thanks, Rich. Good morning, everyone. Q1 marked another record quarter for our commercial organization, reflecting strong execution across the portfolio in continued demand for our innovative therapies.

謝謝，里奇。大家早安。第一季是我們商業組織的另一個創紀錄的季度，反映出我們整個產品組合的強勁執行力以及市場對我們創新療法的持續需求。

As Rich mentioned, Catalyst had an excellent start to 2025, driven by the combination of sustained organic growth of FIRDAPSE, stable revenues from FYCOMPA, and the steady adoption of a gaming.

正如 Rich 所提到的，Catalyst 在 2025 年取得了良好的開端，這得益於 FIRDAPSE 的持續有機成長、FYCOMPA 的穩定收入以及遊戲的穩步採用。

Q1 total net revenues of 141.4 million positions Catalyst well to achieve our combined 2025 total revenue guidance of $545 million and $565 million.

第一季總淨收入 1.414 億美元，使 Catalyst 預計將實現我們對 2025 年總營收的預期，即 5.45 億美元和 5.65 億美元。

Also, I am pleased to report that we successfully completed the commercial field team restructuring, establishing dedicated sales teams for AGAMREE and FIRDAPSE.

此外，我很高興地報告，我們成功完成了商業領域團隊重組，為 AGAMREE 和 FIRDAPSE 建立了專門的銷售團隊。

This realignment strengthens our focus within each therapeutic area and sets a strong foundation for future growth.

這項調整加強了我們在每個治療領域的重點，並為未來的發展奠定了堅實的基礎。

Let me walk through key performance highlights by product. First, I'll start with FIRDAPSE performance.

讓我來逐一介紹一下產品的主要性能亮點。首先，我將從 FIRDAPSE 效能開始。

Q1 FIRDAPSE net product revenue of 83.7 million represents a 25.3% increase quarter over the same quarter last year, a direct result of strong new patient starts and a low annual discontinuation rate of approximately 15%.

Q1 FIRDAPSE 淨產品收入為 8,370 萬美元，比去年同期增長 25.3%，這直接得益於強勁的新患者開始治療以及約 15% 的低年停藥率。

Prescription approval rates were greater than 90% across all payers, government or private commercial insurers.

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%。

We continue to see strong leading indicators in April, furthering our confidence in achieving FIRDAPSE full year net product revenue guidance of $355 million and $360 million in 2025.

4 月我們繼續看到強勁的領先指標，這進一步增強了我們對實現 FIRDAPSE 全年淨產品收入預期 3.55 億美元和 2025 年 3.6 億美元的信心。

As we look ahead, our strategic growth initiatives remain a key driver for organic growth. We continue to maintain a pipeline of greater than 500 potential LEMS patients in various stages of their diagnostic journey who have not yet started treatment with FIRDAPSE, representing roughly 50% of our new patient enrolments each quarter.

展望未來，我們的策略成長計劃仍然是有機成長的主要驅動力。我們繼續維護著一支由 500 多名處於診斷各個階段的潛在 LEMS 患者組成的隊伍，這些患者尚未開始接受 FIRDAPSE 治療，約占我們每季度新入組患者的 50%。

Furthermore, we are particularly excited about the opportunity in cancer associated LEMS, where we are expanding our focus to the community oncology channel, which manages the majority of cancer care in the US.

此外，我們對癌症相關的 LEMS 的機會感到特別興奮，我們正在將重點擴展到社區腫瘤學管道，該管道管理著美國的大部分癌症治療。

We are confident that potential BGCC antibody screening arrangements with GPOs in the second half of 2025 will help accelerate LEMS diagnosis rates in the approximately 90% of small cell lung cancer LEMS patients who are currently undiagnosed.

我們相信，2025 年下半年與 GPO 進行的潛在 BGCC 抗體篩檢安排將有助於加速目前未確診的約 90% 小細胞肺癌 LEMS 患者的 LEMS 診斷率。

Next, I would like to discuss a gaming. We are proud of the continued early market momentum of a AGAMREE and its growing presence in the market as a breakthrough treatment for DMD, as evidenced by Q1 net product revenue of $22 million.

接下來我想討論一下遊戲。我們為 AGAMREE 持續的早期市場發展勢頭及其作為 DMD 突破性治療藥物在市場上的不斷增長的份額感到自豪，第一季淨產品收入達到 2200 萬美元就是明證。

Since the commercial launch of AGAMREE in March 2024, 93% of the TOP45 DMD centres of excellence and 224 unique healthcare providers have submitted an enrolment form for a gari.

自 2024 年 3 月 AGAMREE 商業推出以來，93% 的 TOP45 DMD 卓越中心和 224 家獨特的醫療保健提供者已提交了 gari 的報名表。

We continue to see transitions to a AGAMREE from both corticosteroid segments 44% from prednisone and 44% from Emflaza. Approximately 85% of shipments are successfully reimbursed, which is aligned with our forecast.

我們繼續看到兩種皮質類固醇藥物向 AGAMREE 的轉變，其中 44% 來自潑尼松，44% 來自 Emflaza。約有 85% 的貨物成功報銷，這與我們的預測一致。

In addition, our dedicated Gamry sales force is actively executing targeted educational initiatives to reinforce a AGAMREE potential for differentiated value, driving durable patient uptake and strengthening our competitive position.

此外，我們專業的 Gamry 銷售團隊正在積極執行有針對性的教育計劃，以強化 AGAMREE 的差異化價值潛力，推動患者持久接受並增強我們的競爭地位。

AGAMREE net product revenue for 2025 is expected to be between 100 million and $110 million reflecting its continued market adoption and commercial momentum.

AGAMREE 2025 年的淨產品收入預計將達到 1 億至 1.1 億美元之間，這反映了其持續的市場應用和商業發展勢頭。

Lastly, I would like to provide a brief overview of FYCOMPA.

最後，我想簡單介紹一下FYCOMPA。

BCAA delivered solid Q1 net product revenues of 35.6 million, further fortifying our revenue diversification.

BCAA 在第一季實現了 3,560 萬美元的穩健淨產品收入，進一步加強了我們的收入多元化。

Looking ahead, we are closely managing the upcoming FYCOMPA loss of exclusivity.

展望未來，我們正在密切管理即將到來的 FYCOMPA 獨家經營權的喪失。

While we anticipate revenue impact in the second half, we have mitigation plans in place to appropriately minimize brand erosion.

雖然我們預計下半年的收入會受到影響，但我們已經制定了緩解計劃，以適當減少品牌侵蝕。

We remain confident in our full year 2025 net product revenue forecast for FYCOMPA of between 90 million and $95 million. To summarize, our commercial organization continues to execute with precision, supported by a strong field force and focused strategies across our portfolio.

我們仍然對 FYCOMPA 2025 年全年淨產品收入預測充滿信心，該收入將在 9,000 萬至 9,500 萬美元之間。總而言之，我們的商業組織在強大的現場力量和整個投資組合的重點策略的支持下，繼續精準執行。

Following a strong first quarter and sustained momentum across the business, we are confident in reaffirming our full year 2025 total revenue guidance.

由於第一季的強勁表現和整個業務的持續成長勢頭，我們有信心重申 2025 年全年總營收預期。

We believe that we are well positioned to seize the growth opportunities ahead, and we remain focused on driving operational excellence, enhancing patient access, and scaling our commercial impact across our entire product portfolio.

我們相信，我們已準備好抓住未來的成長機遇，並且我們將繼續專注於推動卓越營運、增強患者可及性以及擴大我們整個產品組合的商業影響力。

I will now turn the call back over to Mike.

我現在將電話轉回給麥克。

Thanks Jeff. Our performance during the first quarter of 2025 has set us on pace for another strong year.

謝謝傑夫。2025 年第一季的業績為我們迎來另一個強勁的一年奠定了基礎。

Driven by our solid financial performance, financial discipline, and strong execution.

由我們穩健的財務表現、財務紀律和強有力的執行力推動。

With the continued success from the launch of AGAMREE in mid-March of 2024, along with the continued performance of FIRDAPSE and FYCOMPA, we have set the groundwork for what promises to be yet another strong year in 2025, and we reaffirm our 2025 full year total revenue guidance that we provided in February.

隨著 2024 年 3 月中旬 AGAMREE 的推出不斷取得成功，以及 FIRDAPSE 和 FYCOMPA 的持續表現，我們為 2025 年又一個強勁的一年奠定了基礎，我們重申我們在 2 月份提供的 2025 年全年總收入指導。

We remain steadfast in our commitment to driving growth, leveraging strategic arrangements, and expanding our portfolio to capitalize on emerging opportunities throughout the year.

我們堅定不移地致力於推動成長、利用策略安排和擴大投資組合，以利用全年新興機會。

Our total revenues for the first quarter of 2025 were $141.4 million a 43.6% increase when compared to total revenues of $98.5 million for the first quarter of 2024.

我們 2025 年第一季的總營收為 1.414 億美元，與 2024 年第一季的總營收 9,850 萬美元相比成長了 43.6%。

Product revenue net for our lead product FIRDAPSE was $83.7 million a 25.3% increase year over year compared to $66.8 million in Q1 2024.

我們主打產品 FIRDAPSE 的產品淨收入為 8,370 萬美元，與 2024 年第一季的 6,680 萬美元相比年增 25.3%。

Primarily driven by an increase in sales volumes, a portion of which is attributed to a delay in patient claims to certain non-Meddicare payers in certain states resulting from the changed healthcare cybersecurity incident that occurred in the 1st quarter of 2024 and was resolved in the 2nd quarter of 2024.

主要受銷售量成長推動，部分原因是 2024 年第一季發生的醫療保健網路安全事件導致某些州的某些非醫療保險支付方的患者索賠延遲，該事件已於 2024 年第二季度得到解決。

The first quarter of 2025 also reflects a small amount of revenue for shipments to sub licensees outside of the US. Product revenue net for the first quarter of 2025 for AGAMREE was $22 million compared to $1.2 million in the first quarter of 2024.

2025 年第一季也反映了向美國境外分證持有者出貨的少量收入。AGAMREE 2025 年第一季的產品淨收入為 2,200 萬美元，而 2024 年第一季為 120 萬美元。

As mentioned earlier, AGAMREE was made commercially available in mid-March 2024.

如前所述，AGAMREE 於 2024 年 3 月中旬投入商業使用。

The results underscore continued growth and increasing prescriber engagement.

結果強調了持續的成長和處方者參與度的提高。

Product revenue net for the first quarter of 2025 for FYCOMPA was $35.6 million compared to $30.4 million in the first quarter of 2024, which included a reduction in variable consideration or gross net resulting from a decrease in wholesaler distribution fees in 2025.

FYCOMPA 2025 年第一季的產品收入淨額為 3,560 萬美元，而 2024 年第一季為 3,040 萬美元，其中包括 2025 年批發商分銷費減少導致的變動對價或淨收入減少。

We expect that product revenue net for FYCOMPA will likely decrease once the patent protection expires, which occurs on May 23, 2025, for the tablets, and on December 15, 2025, for the oral suspension.

我們預計，一旦專利保護到期，FYCOMPA 的產品收入淨額可能會減少，片劑的專利保護到期日為 2025 年 5 月 23 日，口服混懸液的專利保護到期日為 2025 年 12 月 15 日。

Net income before income taxes for the first quarter of 2025 was $71.3 million a 145% increase year over year compared to $29.1 million for the first quarter of 2024.

2025 年第一季的稅前淨收入為 7,130 萬美元，與 2024 年第一季的 2,910 萬美元相比成長 145%。

We reported GAAP net income for the first quarter of 2025 of $56.7 million or $0.47 per basic and $0.45 per diluted share, an increase of 144% year over year compared to GAAP net income for the first quarter of 2024 of $23.3 million or $0.20 per basic and $0.19 per diluted share.

我們報告的 2025 年第一季 GAAP 淨收入為 5,670 萬美元，即基本每股 0.47 美元，稀釋每股 0.45 美元，與 2024 年第一季 GAAP 淨收入 2,330 萬美元或基本每股 0.20 美元和稀釋每股 0.19 美元相比同比增長 144%。

As a reminder, in the 1st quarter of the calendar year, like many companies in our industry, we are impacted by the reset of patient insurance deductibles.

提醒一下，在日曆年的第一季度，與我們行業中的許多公司一樣，我們受到患者保險免賠額重置的影響。

Cost of sales expense was approximately $17.9 million in the first quarter of 2025 compared to $12.5 million in the first quarter of 2024 and consisted principally of royalties.

2025 年第一季的銷售費用約為 1,790 萬美元，而 2024 年第一季為 1,250 萬美元，主要包括特許權使用費。

The gari royalties paid to the product license or increased by 2% when a AGAMREE net product revenue exceeds $100 million in any calendar year.

當 AGAMREE 淨產品收入在任何日曆年超過 1 億美元時，支付給產品許可證的 gari 特許權使用費將增加 2%。

The company is also required to make a $12.5 million dollar milestone payment once the AGAMREE net product revenue reaches $100 million which will be capitalized once achieved and advertised as part of cost of goods sold over the remaining estimated useful life of the intangible asset.

一旦 AGAMREE 淨產品收入達到 1 億美元，該公司還需要支付 1,250 萬美元的里程碑付款，這筆款項將在實現後資本化，並在無形資產剩餘的預計使用壽命內作為銷售成本的一部分進行宣傳。

Non-gap net income for the first quarter of 2025 was $86.6 million or $0.71 per basic and $0.68 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FYCOMPA, AGAMREE, and Resurgi of $9.3 million.

2025 年第一季的非缺口淨收入為 8,660 萬美元，即基本每股 0.71 美元，稀釋每股 0.68 美元，不包括與我們收購 FYCOMPA、AGAMREE 和 Resurgi 相關的 930 萬美元的 GAAP 淨收入無形資產攤銷。

Stock-based compensation expense of $5.9 million the income tax provision of $14.5 million and depreciation of $115,000.

股票型薪資費用為 590 萬美元，所得稅準備金為 1,450 萬美元，折舊費為 115,000 美元。

That this compares to non-gap net income in the first quarter of 2024 of $46.8 million or $0.40 per basic and $0.38 per diluted share.

相比之下，2024 年第一季的非差距淨收入為 4,680 萬美元，即每股基本收入 0.40 美元，每股稀釋收入 0.38 美元。

Which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FYCOMPA, AGAMREE, and Resurgi of $9.3 million stock-based compensation expenses of $8.2 million the income tax provision of $5.8 million and depreciation of $86,000.

其中不包括與我們收購 FYCOMPA、AGAMREE 和 Resurgi 相關的 GAAP 淨收入無形資產攤銷 930 萬美元、股票薪酬費用 820 萬美元、所得稅準備金 580 萬美元和折舊 86,000 美元。

Our effective tax rate for the first quarter of 2025 was 20.4% compared to 20% for the first quarter of 2024.

我們 2025 年第一季的有效稅率為 20.4%，而 2024 年第一季的有效稅率為 20%。

We expect the 2025 annualized effective tax rate to be relatively consistent with the 2024 annual rate of 24.2%. For the first quarter of 2025, the difference to the statutory federal income tax rate of 21% was primarily driven by state income taxes, fluctuations in the value of investments, and anticipated annual permanent differences.

我們預期 2025 年年化有效稅率將與 2024 年 24.2% 的年稅率相對一致。2025 年第一季度，與法定聯邦所得稅率 21% 的差異主要受州所得稅、投資價值波動和預期年度永久性差異的影響。

The 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.

有效稅率受多種因素影響，包括任何特定期間內行使的股票選擇權數量，並且可能在未來期間內波動。

Further, we are required to pay royalties based on net product revenue to the product license or for FYCOMPA following the loss of exclusivity, which will occur later this month for tablets and in December 2025 for the oral suspension.

此外，我們需要根據淨產品收入向產品許可證或 FYCOMPA 支付特許權使用費，因為在失去獨佔權之後，片劑的特許權使用費將於本月晚些時候支付，口服混懸液的特許權使用費將於 2025 年 12 月支付。

The royalty rates are higher if there is no generic entry following loss of patent exclusivity than they are once generics enter the market. As a reminder, royalties preferred apps increased by 3% when net product sales exceed $100 million in any calendar year.

如果在專利獨佔權喪失後沒有仿製藥進入市場，則專利費率會比仿製藥進入市場後的專利費率更高。提醒一下，當任何日曆年的淨產品銷售額超過 1 億美元時，優先應用程式的版稅將增加 3%。

As a result, we expect the cost of sales to trend higher as the year progresses. Additionally, I would like to note that again we also carries the royalty in the range of low double digit to mid-20%.

因此，我們預期隨著時間的推移，銷售成本將呈現上升趨勢。此外，我想再次指出，我們的版稅也處於低兩位數到 20% 左右的範圍內。

Depending on sales achievements within a calendar year.

取決於一個日曆年內的銷售業績。

Further details on our royalty obligations for gay are disclosed in our Q120 25 Form 10Q and are expanded upon within the MDNA section. Research and development expense was $3.9 million in the first quarter of 2025, up from $2.6 million in the first quarter of 2024.

有關我們對同性戀的版稅義務的更多詳細資訊已在我們的 Q120 25 表格 10Q 中披露，並在 MDNA 部分中進行了詳細說明。2025 年第一季的研發費用為 390 萬美元，高於 2024 年第一季的 260 萬美元。

During the three months ended March 30, 2025, research and development expenses consisted of costs for company sponsored research and development activities. Support for selected investigator sponsored research and support for our commercial activities.

在截至 2025 年 3 月 30 日的三個月內，研發費用包括公司贊助的研發活動的成本。支持選定的研究者贊助的研究並支持我們的商業活動。

The company anticipates full year 2025 research and development expenses to range between $15 million and $20 million excluding the impact of any additional acquisitions, reflecting investments in the summit study and the start of initiatives to investigate the potential for a gas label to be expanded in the future.

該公司預計，2025 年全年研發費用將在 1500 萬美元至 2000 萬美元之間（不包括任何額外收購的影響），這反映了對峰會研究的投資以及啟動調查未來擴大氣體標籤潛力的計劃。

As GA expenses for the first quarter of 2025 totalled $46.9 million flat as compared to $46.9 million in Q1 2024. However, at this point, SG&A expenses are expected to increase modestly over the remainder of the year, reflecting personnel additions during 2024 and the strategic alignment of dedicated commercial teams supporting FYCOMPA and AGAMREE, which became effective in the start of the 2025 2nd quarter.

2025 年第一季的 GA 費用總計 4,690 萬美元，與 2024 年第一季的 4,690 萬美元持平。不過，目前，預計銷售、一般及行政費用 (SG&A) 在今年剩餘時間內將小幅增加，這反映了 2024 年人員的增加以及支持 FYCOMPA 和 AGAMREE 的專門商業團隊的戰略調整，該調整於 2025 年第二季度初生效。

As reported, we ended the first quarter of 2025 with cash and cash equivalents of $580.7 million compared to $517.6 million at December 31, 2024.

據報道，截至 2025 年第一季度，我們的現金和現金等價物為 5.807 億美元，而 2024 年 12 月 31 日為 5.176 億美元。

The increase in cash of $63.1 million was largely driven by $60 million in cash generated from operations of our business.

現金增加 6,310 萬美元，主要是由於我們業務營運產生的 6,000 萬美元現金。

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，我們目前的資金將繼續使我們能夠靈活地資助現有的研發項目，履行潛在的合約義務，並支持我們的策略計劃、業務發展和投資組合擴展工作，從而實現長期成長和價值創造。

More detailed information and analysis of our first quarter 2025 financial performance may be found in our quarterly report on Form 10Q, which was filed with the Securities and Exchange Commission yesterday, May 7, and can be found in our investor relations page on our website at www.catalystpharma.com.

有關我們 2025 年第一季財務業績的更多詳細資訊和分析，請參閱我們昨天（5 月 7 日）向美國證券交易委員會提交的 10Q 表季度報告，也可在我們網站 www.catalystpharma.com 的投資者關係頁面上找到。

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

說完這些，我會把電話轉回給里奇。

As you heard throughout today's call, Catalyst enters the remainder of 2025 with strong momentum, strategic focus, and a clear commitment to delivering value across the rare disease portfolio.

正如您在今天的電話會議中所聽到的，Catalyst 將以強勁的勢頭、戰略重點和在罕見疾病產品組合中創造價值的明確承諾進入 2025 年剩餘時間。

We're executing with discipline, advancing initiatives that support near term performance, taking steps to create long term value and growth.

我們嚴格執行紀律，推進支持近期業績的舉措，採取措施創造長期價值和成長。

The quarter's results reflect the strength of our execution, the resilience of our model, and the depth of the talent across the organization.

本季的業績反映了我們的執行力、我們模式的彈性以及整個組織的人才深度。

I want to thank our employees, partners, and stakeholders for their continued dedication. As we look ahead, I'm confident in our abilities to drive meaningful impact and sustain value.

我要感謝我們的員工、合作夥伴和利害關係人的持續奉獻。展望未來，我相信我們有能力產生有意義的影響力並維持價值。

Thank you for joining us today. I'll now turn the call back over to the operator for questions.

感謝您今天加入我們。我現在將把電話轉回給接線員以回答問題。

Thank you.

謝謝。

Thank you, at this time, if you would like to ask a question, (Operator Instructions)

謝謝，現在如果你想問一個問題，（操作員指示）

And our first question will come from Joon Lee with Truist Securities. Please go ahead.

我們的第一個問題來自 Truist Securities 的 Joon Lee。請繼續。

Congrats on the quarter and the beat. This is Asumrano on for Joon. Thanks for taking the question, just a couple from us. FIRDAPSE saw a 25% growth from last year. How much of that would you say is strength in this quarter versus weakness in last year's 12 due to the change in healthcare impact?

恭喜本季和本季的業績。這是 Asumrano 為 Joon 表演的。感謝您回答這個問題，我們只提幾個問題。FIRDAPSE 比去年成長了 25%。您認為由於醫療保健影響的變化，本季的強勁表現與去年 12 季的疲軟表現相比，在多大程度上有所體現？

And then as a follow up, can you remind us what proportion of like FIRDAPSE patients on the tablet formulation versus the oral suspension formulation.

然後作為後續問題，您能否提醒我們，服用片劑和口服混懸液製劑的 FIRDAPSE 患者的比例是多少。

Thank you.

謝謝。

Thanks for the for the question. As we alluded to, there was some shift in the business due to the change healthcare. I'm going to turn it to Jeff to address the question and then Jeff will also address the Phi Copa question as well.

感謝您的提問。正如我們所提到的，由於醫療保健的變化，業務發生了一些轉變。我將讓傑夫來回答這個問題，然後傑夫也會回答 Phi Copa 的問題。

Sure, and for regarding the strength of the business, we always say 15 to 20% growth is what we aim for apps, and that's the range that we fell, in 1, so it's about 15 to 20%. We saw strong enrollments though. Continuation rates and we continue to see great leading indicators in.

當然，就業務實力而言，我們總是說 15% 到 20% 的成長是我們應用程式的目標，而這正是我們 1 月的成長率範圍，大約是 15% 到 20%。不過，我們看到入學人數強勁。延續率和我們繼續看到出色的領先指標。

So just to really put a bow on that, if you were to back out the effect of change health care, you'd still be in that 15 to 20% range. Is that right? Yeah.

因此，為了真正解決這個問題，如果你放棄改變醫療保健的影響，你仍然會處於 15% 到 20% 的範圍內。是嗎？是的。

Asma, is that clear?

阿斯瑪，明白了嗎？

Very clear. Thank you. And then just on the proportion of my complications that are on the tablets, the oral suspension formulation.

非常清楚。謝謝。然後僅討論藥片和口服混懸液製劑引起的併發症的比例。

Tablet versus. It's probably about, I'm sorry, yeah. It's about 15, I'm sorry, it's about 98%.

平板電腦對比。可能是這樣，對不起，是的。大概是15左右吧，對不起，大概是98%左右。

Tablet okay.

平板電腦還可以。

Thank.

感謝。

You. Very helpful.

你。非常有幫助。

Thank you.

謝謝。

Our next question will come from Samantha Seminatko with Citi. Please go ahead.

我們的下一個問題來自花旗銀行的 Samantha Seminatko。請繼續。

Hello.

你好。

This is Benjamin Paluch for Samantha. Thanks for taking the questions. How is the uptake of FIRDAPSE's among small cell lung cancer patients trending? Are you seeing an impact from your patients' green efforts in this population, and how should we think about growth from small cell lung cancer versus idiopathic patients over the next several quarters?

我是本傑明·帕魯克 (Benjamin Paluch)，為您介紹薩曼莎 (Samantha)。感謝您回答這些問題。小細胞肺癌患者對 FIRDAPSE 的接受趨勢如何？您是否看到患者的綠色努力對這一人群產生了影響？我們該如何看待未來幾季小細胞肺癌患者與特發性肺癌患者的成長？

Thanks for the question, Benjamin. I can turn it over to Jeff.

謝謝你的提問，班傑明。我可以把它交給傑夫。

So our current mix, for all our patients currently on furs, about 20 to 25.

因此，對於所有使用毛皮的患者，我們目前的混合毛皮種類大約是 20 到 25 種。

Are cancer associated LEMS patients. Our goal for this year is to really focus on our VGCC antibiotic screening arrangements with GPOs and community oncologists. So, with that, again, we want to focus on screening and helping these patients that about 90% of small cell lung cancer patients with LEMS are currently undiagnosed. So, our goal is to help them get diagnosed and in 200. In 206 that's when we'll be able to help patients transition onto therapy.

是癌症相關的 LEMS 患者。我們今年的目標是真正專注於與 GPO 和社區腫瘤學家進行 VGCC 抗生素篩檢安排。因此，我們再次強調，要專注於篩檢和幫助這些患者，因為目前大約 90% 的 LEMS 小細胞肺癌患者尚未被診斷出來。因此，我們的目標是幫助他們在 200 歲時得到診斷。到 206 年，我們將能夠幫助患者過渡到治療階段。

So that's our goal in the long term we expect that 20 to 25% to grow to, potentially 30-35%.

所以這是我們的長期目標，我們預期成長率為 20% 至 25%，甚至可能達到 30% 至 35%。

Thank you

謝謝

Thank you.

謝謝。

Okay, great.

好的，太好了。

Our next question will come from Joel Beaty with Baird. Please go ahead.

我們的下一個問題來自貝爾德公司的喬爾貝蒂。請繼續。

Hey, congrats on the quarter and thanks for taking the questions.

嘿，恭喜本季取得佳績，感謝您回答問題。

The first one is on business development activities in the past you've put a lot of focus on that.

第一個是過去的業務發展活動，您對此非常重視。

I guess we're currently in what a lot of people are describing as a rapidly changing macro environment.

我想我們目前正處於許多人所描述的快速變化的宏觀環境中。

So what are your current thoughts on business development and are there any recent impacts on that?

那麼您目前對業務發展有何想法？最近有什麼影響嗎？

Thanks for the question, Joel. So, we remain focused on our strategy, which is looking at immediately creative or nearly immediately creative opportunities. So, the dynamics in the market are manyfold, as you point out.

謝謝你的提問，喬爾。因此，我們仍然專注於我們的策略，即尋找立即創造或幾乎立即創造的機會。因此，正如您所指出的，市場動態是多方面的。

We see this as a really beneficial opportunity for us. We continue to see inbounds at about 80%, so the opportunities that come to us are.

我們認為這對我們來說是一個非常有利的機會。我們繼續看到約 80% 的入站量，因此我們面臨的機會是。

Or the opportunities we're assessing, 80% of them are coming to us de novo, so we like that.

或者說，我們正在評估的機會中有 80% 都是從頭開始出現的，所以我們喜歡這樣。

The capital markets, while they're in turmoil, we think present an opportunity for us, which we like as well. And then because of our strategy looking at opportunities that are near the finish line and going commercial.

我們認為，儘管資本市場處於動盪之中，但這也為我們帶來了機遇，我們也對此感到高興。然後，由於我們的策略著眼於接近終點線並實現商業化的機會。

We think this remains relatively unaffected by the regulatory environment and changes in the regulatory environment, so we see this again as beneficial for us in the strategy that we have. So, while it's unsettling, I think in general for our strategy, I think it reinforces our strategy. So, we feel good about where we stand as a company and the strategy that we have.

我們認為這相對不受監管環境和監管環境變化的影響，因此我們再次認為這對我們的策略有利。因此，雖然這令人不安，但我認為就我們的策略而言，它總體上強化了我們的策略。因此，我們對公司現狀和現有策略感到滿意。

Great, that's helpful to hear. And then as a follow up on FIRDAPSE's for cancer associated LEMS, any anecdotes or on things that you've seen working at a smaller scale perhaps that helps give you confidence in the strategy that you're taking to increase the diagnosis rates with the antibody and see that lead to treatment.

太好了，聽到這很有幫助。然後，作為對癌症相關 LEMS 的 FIRDAPSE 的後續研究，任何軼事或您在較小範圍內看到的工作也許可以幫助您對所採取的策略充滿信心，以提高抗體的診斷率並看到其導致治療。

So when you say smaller scale, can you clarify?

那麼當您說規模較小時，您能解釋一下嗎？

Is this something that you've maybe been able to kind of test in certain locations and trying to get into the antibody test? Are we still kind of early in these efforts, but this is a, or maybe another way to ask is that you've had a lot of success in non-cancer associated lumps marketing, but this is this is a different approach, so what kind of gives you confidence that you can be successful in this setting as well.

您是否可以在某些地方進行此類測試並嘗試進行抗體測試？我們是否仍處於這些努力的早期階段，或者換句話說，您在非癌症相關腫塊行銷方面已經取得了很大成功，但這是一種不同的方法，那麼什麼讓您有信心您也可以在這種情況下取得成功。

Great. Okay. So, I think let me let me start and then I'll turn it over to Jeff. So, I think what you're asking is, have we, in our dialogue with the oncology community, have we seen interest in this?

偉大的。好的。所以，我想讓我先開始，然後我會把它交給傑夫。所以，我想你想問的是，在我們與腫瘤學界的對話中，我們是否看到了對此的興趣？

And the answer is a definite yes. We're talking to these larger groups, and you know there's been a consolidation of these oncology practices in larger groups, and our dialogue with these oncology groups, we're seeing a definite interest in this because they realized that as Jeff has alluded to in previous discussions, 90% of the patients with small cell lung cancer.

答案是肯定的。我們正在與這些更大的團體進行交流，您知道，這些腫瘤學實踐已經在更大的團體中得到整合，而且我們與這些腫瘤學團體的對話中，我們看到了對此的明確興趣，因為他們意識到，正如 Jeff 在之前的討論中提到的那樣，90％ 的患者患有小細胞肺癌。

Associated LEMS are not getting treated and so they see the dynamic. They see the unmet clinical and medical need and so when we talk to them about it and the ability to diagnose and then thus treat with a definitive treatment, there is a definite interest. But Jeff, you're closer to the subject. You want to Absolutely.

相關的 LEMS 沒有得到治療，因此他們看到了這種動態。他們看到了未滿足的臨床和醫療需求，因此當我們與他們談論這一點以及診斷能力並因此採取明確的治療方法時，他們表現出了明顯的興趣。但是傑夫，你更接近主題了。你當然想要。

There have been significant ad boards that have been done with these thought leaders over the last year or 2 years.

在過去的一兩年裡，我們與這些思想領袖合作製作了大量廣告看板。

So like Rich mentioned, significant interest among these key opinion leaders and also, our goal is to help provide frictionless testing for these patients so that these 90% of patients that are undiagnosed can get tested and hopefully diagnosed. And in our, in those discussions, these physicians again, they see the unmet need for these small cell lung cancer patients. So, there's significant interest out there in the oncology community.

因此，正如 Rich 所提到的，這些關鍵意見領袖對此非常感興趣，而且我們的目標是幫助為這些患者提供無摩擦檢測，以便 90% 未確診的患者能夠接受檢測並有望得到診斷。在我們的討論中，這些醫生再次看到了小細胞肺癌患者尚未滿足的需求。因此，腫瘤學界對此表現出濃厚的興趣。

So is that helpful?

這樣有幫助嗎？

Yeah. I just want to correct one thing. I believe I misspoke before when the question came up about the split between and solid tablets. It's actually 85%, so I apologize.

是的。我只想糾正一件事。我認為，當問題涉及和固體片劑之間的區別時，我之前說錯了。實際上是 85%，所以我很抱歉。

So it's 85% are tablets and 15% is oral solution on FYCOMPA, so my apologies to the group.

因此，FYCOMPA 中的 85% 是片劑，15% 是口服溶液，因此我向小組表示歉意。

Thank you.

謝謝。

Our next question will come from Charles Duncan with Cantor Fitzgerald. Please go ahead.

我們的下一個問題來自 Cantor Fitzgerald 的 Charles Duncan。請繼續。

A morning rich and team.

富有團隊的早晨。

First of all, congratulations on the first quarter performance. Secondly, thanks for taking our question. I had a question on FIRDAPSE and in the guidance that you've given, it's uncommonly tight, and I guess I'm wondering, you've been tracking like 500 patients for several years.

首先恭喜第一季的業績。其次，感謝您回答我們的問題。我對 FIRDAPSE 有一個疑問，在您給予的指導中，它異常嚴格，我想知道，您已經追蹤了 500 名患者好幾年了。

And about half of them, or I guess the new to brand or new patient starts come from that pool. I'm wondering if you could give us some color on, how you're setting that guidance. If I, if I look at, call it a 15% growth, thus far this year, that's closing in on 390, not 360. So I'm wondering what is the source of your conservativism with regard to FIRDAPSE guidance?

我猜其中大約有一半的新品牌或新患者都來自這個群體。我想知道您是否可以向我們詳細說明您是如何制定該指導的。如果我將其稱為 15% 的增長，那麼今年到目前為止，這個數字接近 390，而不是 360。所以我想知道您對 FIRDAPSE 指導持保守態度的原因是什麼？

The source of our conservatism, Charles.

我們的保守主義的源頭，查爾斯。

Yeah, well, yeah, I mean, in terms of new patient ads or persistence or growth in average daily dosing, we, where do you, where do you stand on what the most important trigger there is?

是的，嗯，是的，我的意思是，就新病患廣告或平均每日劑量的持久性或成長而言，您認為最重要的觸發因素是什麼？

Okay, Jeff, you want to take that? Yeah, hey, Charles, good.

好的，傑夫，你想接受這個嗎？是的，嘿，查爾斯，很好。

Morning. As far as what I can talk about are the leading indicators for us in our core business, and we've seen it over the last, 15 quarters now that 15% growth. And like you mentioned, the 500 patients or so that are pipeline, patients that are somewhere in their diagnostic journey for LEMS, we have significant resources or sources to find, continue to backfill the patients after they get on therapy to find new leads so that we always have about 500.

早晨。就我所能談論的是我們核心業務的領先指標，我們已經看到過去 15 個季度的成長率達到 15%。正如您所提到的，大約有 500 名患者正在接受 LEMS 診斷，我們擁有大量的資源或來源，在患者接受治療後，我們會繼續補充這些患者，以尋找新的線索，這樣我們就能一直有大約 500 名患者。

Our discontinuation rates remain low at 15%, over time, we see what our trend is for our net new patients each month, any given quarter. So that's what helps inform us about where our growth is. In our confidence. So, this is our 6th year out. So, we kind of understand where the trend is and where we're headed.

我們的停藥率仍然保持在 15% 的低水平，隨著時間的推移，我們可以看到每個月、每季淨新增患者的趨勢。這有助於我們了解我們的成長方向。我們有信心。這是我們離開的第六年了。因此，我們大概了解趨勢在哪裡以及我們的發展方向。

So that's what gives us the confidence. Hopefully that that helps, Charles. I don't know if there's any follow-up question that you can ask that can point me in the in the direction that you want me to go.

這就是讓我們充滿信心的原因。希望這能有所幫助，查爾斯。我不知道您是否可以提出任何後續問題來為我指明您希望我去的方向。

No, I think that that's good. I understand the confidence, but I definitely think it's conservative, my perspective. Maybe we'll move on to FYCOMPA, and that is you mentioned measured revenue decline, and that makes sense for an epilepsy indication. You said that this year you have measures in place.

不，我認為那很好。我理解這種信心，但我確實認為這是保守的觀點。也許我們會轉向 FYCOMPA，這就是您提到的衡量收入下降，這對於癲癇症的適應症來說是有意義的。您說今年已經採取措施了。

Could those measures also apply to next year? I know you're not guiding to next year, but is it inherent in the use of FYCOMPA that use may continue for those patients in the next year?

這些措施明年也適用嗎？我知道您沒有指導明年的情況，但是 FYCOMPA 的使用是否意味著這些患者明年可以繼續使用？

Charles, there tends to be stickiness, for lack of better terms, for anti-seizure medications.

查爾斯，由於缺乏更好的術語，抗癲癇藥物往往會具有黏性。

So there is an opportunity there for patients to, or to, minimize brand erosion over time.

因此，患者有機會隨著時間的推移盡量減少品牌的侵蝕。

We haven't given that guidance, as you mentioned, for next year. But yeah, I mean, there is an opportunity to, minimize brand erosion continuing into the next Year.

正如您所說，我們還沒有給出明年的指導。但是的，我的意思是，有機會將品牌侵蝕的勢頭降至最低，並持續到明年。

I think the challenge with that, Charles, is that the 6-month exclusivity period ends at the end of this year, and then while we don't know it, we would expect additional generics to enter the market. And at that point, while we haven't, as Jeff has alluded to, we haven't given guidance for 2026. We all know the way that Price is inversely proportional to the number of players in the generic market, so I think it just becomes tougher to control.

查爾斯，我認為其中的挑戰在於，六個月的獨佔期將在今年年底結束，然後，雖然我們不知道，但我們預計會有更多的仿製藥進入市場。而目前，正如傑夫所暗示的，我們還沒有給出 2026 年的指導。我們都知道，價格與仿製藥市場的參與者數量成反比，所以我認為控制起來會變得更加困難。

Okay, last question on biz dev, helpful color so far, but in terms of the market and the environment, it does seem like it Favors your approach and your task position. I'm wondering if you have specific goals for this year to get a transaction done, or is that something you don't want to commit to at this point?

好的，關於業務開發的最後一個問題，到目前為止很有幫助，但就市場和環境而言，它似乎確實有利於您的方法和任務定位。我想知道您今年是否有完成交易的具體目標，或者這是您目前不想承諾的事情？

I would, I wouldn't say we have a specific goal to get a transaction done. We have a specific goal to get the right transaction done or right transactions done.

我不會說我們有一個完成交易的特定目標。我們有一個特定的目標，就是完成正確的交易。

I think we've been very good as a company in bringing in the appropriate assets, and we want to continue that trend. We want to make sure we bring in the right assets.

我認為我們公司在引進適當資產方面做得非常好，我們希望繼續保持這種趨勢。我們希望確保引入正確的資產。

We've looked at a lot of opportunities and for a number of reasons they don't fit us, and they don't make sense for us. It would be Unfortunate for us to bring in an opportunity that didn't fit us culturally, financially, structurally, and so all of those things have to fit, and we are, I think, a very discriminating buyer of assets and acquirer of assets, and we want to continue that because we think that's beneficial for shareholders and beneficial for us as a company. And so I'm not trying to parse words, but we have a goal to do the right deal.

我們考慮過很多機會，但由於種種原因，它們並不適合我們，對我們來說沒有意義。如果我們引入的機會在文化、財務和結構上不適合我們，那將是不幸的，所以所有這些都必須適合，我認為，我們是一個非常有辨別力的資產買家和資產收購者，我們希望繼續這樣做，因為我們認為這對股東有利，對我們公司也有利。因此，我並不是想分析這些詞語，但我們的目標是達成正確的交易。

Okay, thanks for taking all my questions.

好的，感謝您回答我的所有問題。

Thanks for your support too as well.

也感謝您的支持。

Thank you.

謝謝。

Our next question will come from Rohan Mathur with Oppenheimer Please go ahead.

我們的下一個問題來自 Oppenheimer 的 Rohan Mathur。請繼續。

Hey, this is Rohan on for Leland Gershell. Thanks for taking the question and congrats on another really strong quarter. Just one for me on a Gammy.

嘿，我是 Leland Gershell 的 Rohan。感謝您回答這個問題，並祝賀您又一個非常強勁的季度。對我來說，Gammy 上只有一個。

As you see the STUMET study progress, what aspects of the AGAMREE profile do you think will resonate most with prescribers, especially those who have yet to incorporate it into their own practice?

正如您所看到的 STUMET 研究進展，您認為 AGAMREE 概況的哪些方面最能引起處方者的共鳴，尤其是那些尚未將其納入自身實踐的處方者？

Thank you.

謝謝。

Thanks. Gary, we have Gary Ingenito, our Chief Medical Officer on the line. Gary, do you want to take that question?

謝謝。加里，我們的首席醫療官加里·英吉尼托 (Gary Ingenito) 接聽了電話。加里，你想回答這個問題嗎？

Thank you, Rich. Yes, Rohan. I think that the demonstration of bone health, bone density, and the effects on cardiac will be some of the key findings that confirm the differentiation of a AGAMREE which we see based upon our preliminary data. And we'll do it again in the long term with the real-world evidence.

謝謝你，里奇。是的，羅翰。我認為，骨骼健康、骨密度和對心臟的影響的證明將是一些關鍵發現，這些發現證實了我們根據初步數據所看到的 AGAMREE 的分化。我們將利用現實世界的證據長期再次這樣做。

Got it. And just a follow up, how do you sort of plan to quantify that in summit?

知道了。接下來的問題是，您計劃如何在峰會上量化這一點？

So in Summit, we will be looking at fracture rates, bone age, bone density and development or prevention of cardiomyopathy

因此在高峰會上，我們將關注骨折率、骨齡、骨密度以及心肌病變的發展或預防

Thank you.

謝謝。

Our next question will come from Jason Gerberry with Bank of America. Please go ahead.

我們的下一個問題來自美國銀行的 Jason Gerberry。請繼續。

Oh hey guys, sorry, I joined late and missed everything so far on the call, so apologies if this has been addressed, but just, can you remind me with the strength of the FIRDAPSE quarter just wondering if there's any pull forward at all just trying to think through the quarterly progression of sales and, furthermore if you can speak to whether you're starting to see strength and performance of the small cell on adoption on the LEMS side there thanks.

哦，嘿夥計們，抱歉，我加入晚了，錯過了電話會議到目前為止的所有內容，如果這個問題已經解決了，請見諒，但是，您能否提醒我一下 FIRDAPSE 季度的強勁表現，只是想知道是否有任何拉動，只是想思考一下季度銷售進展，此外，如果您可以談談您是否開始看到小型基站在 LEMS 方面採用的強勁表現，謝謝。

Jason, thanks. So, we'll turn that first part of the question over to Mike, and then we'll turn the second part of the question over to Jeff

傑森，謝謝。因此，我們將問題的第一部分交給 Mike，然後我們將問題的第二部分交給 Jeff

Hey Jason, thanks for the questions. Thanks for the support, on FIRDAPSE Q1, and we did note it, I would look at it as let's start with we've said consistently 15 to 20% growth. And we maintain that notwithstanding the strong growth in Q1. Some of the Q1 2025 compared to Q1 2024 is actually the Q124 change healthcare cybersecurity incident and that impact timing into Q2.

嘿傑森，謝謝你的提問。感謝您對 FIRDAPSE Q1 的支持，我們確實注意到了這一點，我將其視為我們首先所說的持續 15% 到 20% 的增長。儘管第一季成長強勁，我們仍堅持這一觀點。2025 年第一季與 2024 年第一季相比，部分原因實際上是 Q124 醫療網路安全事件的變化，這對第二季的時間產生了影響。

So if you back that out, Jason, just to clarify, if you back out what happened in 2025,Q1 2024, we are still in the range of a growth of 15 to 20%. Is that helpful?

因此，傑森，如果您回顧一下，只是為了澄清一下，如果您回顧一下 2025 年、2024 年第一季度發生的事情，我們仍然處於 15% 到 20% 的增長範圍內。這樣有幫助嗎？

Yeah, great. And then you just ask the second question so we're all clear on where we stand for your second question.

是的，很棒。然後你只要問第二個問題，這樣我們就都清楚我們對你的第二個問題的立場了。

Yeah, just, how 1 may have been impacted at all like sort of the momentum you're seeing on small cell lung LEMS pick up relative to I guess baseline or year on year comp.

是的，只是，1 可能受到了怎樣的影響，就像您看到的小細胞肺 LEMS 相對於基線或同比的上升勢頭一樣。

Sure. So, Jason, let me get you the baseline where we're at. It's about 20 to 25% of our current FIRDAPSE's patients are cancer associated LEMS patients. Our main focus this year is to get BGCC antibody screening arrangements in place with community oncologists, GPOs. And where we expect to see growth in the percentage of our patients to be cancer associated LEMS patients will be in 2026 and beyond.

當然。那麼，傑森，讓我來為你介紹一下我們現在的狀況。我們目前的 FIRDAPSE 患者中約有 20% 到 25% 是癌症相關的 LEMS 患者。我們今年的主要重點是與社區腫瘤學家、GPO 一起制定 BGCC 抗體篩檢安排。我們預計，到 2026 年及以後，癌症相關 LEMS 患者的比例將會成長。

So that's where we expect the opportunity to be realized more. So again, this year we're hopeful that we can help those 90% of patients that are currently undiagnosed, the small cell lung cancer, LEMS patients that are undiagnosed. We want to help them get tested and diagnosed.

因此，我們期望機會能夠更多地實現。因此，我們今年再次希望能夠幫助目前未確診的 90% 患者，即未確診的小細胞肺癌和 LEMS 患者。我們希望幫助他們接受檢測和診斷。

Got it. Okay, thanks so much.

知道了。好的，非常感謝。

Thanks.

謝謝。

Thank you.

謝謝。

Our last question will come from Sudan Logenin with Stevens. Please go ahead.

我們的最後一個問題來自史蒂文斯的蘇丹洛根寧。請繼續。

Stan, please make sure that you're not muted.

斯坦，請確保你沒有被靜音。

I'm sorry, congrats on the call. This is Felix for Sudan, Loganathan. I have a quick question on FIRDAPSE. Given the high percentage of the undiagnosed LEMS patients.

抱歉，恭喜您接通了電話。我是蘇丹的菲利克斯，洛加納森。我對 FIRDAPSE 有一個簡單的問題。鑑於未確診的 LEMS 患者比例很高。

Can you please give us color in terms of the Proportion of the penetration that you have so far on Fed up.

您能否向我們詳細說明您目前在 Fed up 上的滲透比例？

And what will contribute The percent penetration to increase given that you have initiative to increase diagnosis.

如果您主動增加診斷，什麼有助於增加滲透率？

Thanks for the question. So, we've said recently, JP Morgan in our conference, we said we believe that the size of the market is about $1.2 billion. In today's prices, so no price increases, etc.

謝謝你的提問。因此，我們最近在摩根大通的會議上表示，我們相信市場規模約為 12 億美元。以今天的價格，所以不漲價等等。

If you just look at our sales last year, about $300 that would mean we have about a 25% market penetration across the board. So we believe there's significant upside in this market for us, and this consistent growth that Jeff alluded to the 15 to 20% we've experienced for some time, we believe that we can sustain that and given this cancer associated LEMS initiative and continuing to push.

如果你看看我們去年的銷售額，大約 300 美元，這意味著我們的市場滲透率約為 25%。因此，我們相信這個市場對我們來說具有巨大的上升空間，而且 Jeff 提到的持續增長（我們在一段時間內經歷了 15% 到 20%），我們相信我們可以維持這種增長，並考慮到這項與癌症相關的 LEMS 計劃並繼續推動。

On the idiopathic side or noncancer associated LEMS. We believe that there is a significant opportunity to continue to grow this market, and we're really excited about it. Jeff, any comments?

關於特發性或非癌症相關的 LEMS。我們相信這個市場具有持續成長的巨大機遇，我們對此感到非常興奮。傑夫，有什麼意見嗎？

So like Rich mentioned, I mean, significant opportunity on both in both segments of the LEMS prevalence.

因此，就像 Rich 提到的那樣，LEMS 流行的兩個領域都存在著重大機會。

We expect to see more opportunity to help the small cell lung cancer LEMS patients moving forward. Right now, the idiopathic LEMS , the penetration is strong. However, there's still plenty of opportunity, the 500 or so pipeline patients, those patients that are somewhere in their diagnostic journey, the vast majority of those patients are idiopathic LEMS patients, so we plenty of opportunity to help them in the short term as well. So, both segments, significant opportunity remaining.

我們期待看到更多機會幫助小細胞肺癌 LEMS 患者取得進展。目前，特發性LEMS的滲透力很強。然而，仍然有很多機會，大約 500 名管道患者，那些處於診斷旅程中的患者，絕大多數患者都是特發性 LEMS 患者，因此我們也有很多機會在短期內幫助他們。因此，這兩個領域都存在著巨大的機會。

Thanks, Alex. Appreciate it. Any other questions?

謝謝，亞歷克斯。非常感謝。還有其他問題嗎？

Thank you.

謝謝。

No questions from my side.

我這邊沒有問題。

Thank you very Much

非常感謝

Thank you.

謝謝。

Ladies and gentlemen, this does conclude today's program, and we appreciate your participation. You may disconnect at any time.

女士們、先生們，今天的節目到此結束，感謝你們的參與。您可以隨時斷開連線。