Catalyst Pharmaceuticals Inc (CPRX) 2025 Q3 法說會逐字稿

Greetings and welcome to the Catalyst Pharmaceuticals 3rd quarter 2025 financial results conference call and webcast. At this time, all participants are in listen-only mode. A question-and-answer session will follow a formal presentation. You may be placed in the question queue at any time by pressing 1 on your telephone keypad. We ask that you please ask one question, one follow-up, then return to the queue. If anyone should require operator assistance, please press 0. As a reminder, this conference is being recorded. It's not my pleasure to turn the call over to Chief Financial Officer Mike Kub. Mike, please go Ahead.

各位好，歡迎參加 Catalyst Pharmaceuticals 2025 年第三季財務業績電話會議和網路直播。目前，所有參與者均處於只聽模式。正式演講結束後將進行問答環節。您隨時可以按下電話鍵盤上的 1 鍵加入提問佇列。請您先提一個問題，再提一個後續問題，然後再返回佇列。如果有人需要操作員協助，請按 0。再次提醒，本次會議正在錄影。我不樂意把電話轉給財務長麥克·庫布。麥克，請繼續。

Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's 3rd quarter 2025 financial results and business highlights.

謝謝。各位早安，感謝各位參加我們的電話會議，討論 Catalyst 2025 年第三季的財務表現和業務亮點。

Richard Daley, President and CEO will lead the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also present.

今天，總裁兼執行長理查德·戴利將主持電話會議，首席商務官傑弗裡·德爾·卡門和我也會進行演講。

Additionally, Doctor Steven Miller, our Chief Operating Officer and Chief Scientific Officer, and Doctor Will Andrews, our Chief Medical Officer, will be available for the Q&A.

此外，我們的營運長兼首席科學官史蒂文·米勒博士和首席醫療官威爾·安德魯斯博士將出席問答環節。

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

在開始之前，我想提醒各位，在今天上午的演講和問答環節中，我們將對預期的未來業績做出陳述，這些陳述可能構成聯邦證券法意義上的前瞻性陳述。

These statements reflect our current expectations, estimates, and projections and do not guarantee future performance.

這些聲明反映了我們目前的預期、估計和預測，並不能保證未來的表現。

They involve risks, uncertainties, and assumptions that are difficult to predict and may not prove to be accurate.

它們涉及難以預測且可能不準確的風險、不確定性和假設。

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

實際結果可能與我們前瞻性聲明中所述的預期有所不同。

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

這些前瞻性聲明只能結合我們向美國證券交易委員會提交的文件中所包含的詳細資訊來考慮，包括我們在 2025 年 2 月 26 日向美國證券交易委員會提交的 2024 年 10-K 表格年度報告中描述的風險因素。

And in our subsequent filings with the SEC, including our 3rd quarter 2025 quarterly report on Form 10, which was filed yesterday, November 5th, 2025 with the SEC.

隨後，我們在向美國證券交易委員會提交的文件中，包括我們於昨天（2025 年 11 月 5 日）向美國證券交易委員會提交的 2025 年第三季 10 表格季度報告。

At this time I'll turn the call over to Rich. Rich.

現在我將把電話轉給里奇。富有的。

Thanks, Mike. Good morning, everyone, and thank you for joining us.

謝謝你，麥克。各位早安，感謝各位的參與。

Today's call will begin with an overview of our portfolio highlights and key strategic growth initiatives, followed by a detailed discussion of our commercial performance and financial results for the quarter.

今天的電話會議將首先概述我們的投資組合亮點和關鍵策略成長舉措，然後詳細討論我們本季的商業表現和財務表現。

Catalyst delivered outstanding 3rd quarter 2025 results with accelerating momentum, strong demand for our rare disease therapies, and continued progress on key strategic growth priorities.

Catalyst 2025 年第三季業績表現出色，發展勢頭強勁，罕見病療法需求旺盛，關鍵策略成長重點領域持續取得進展。

These results highlight our growing positive impact on the patient communities we serve and demonstrate our unwavering commitment to operational excellence and delivering long-term value.

這些成果凸顯了我們對所服務的患者群體日益增長的正面影響，並展現了我們對卓越營運和提供長期價值的堅定承諾。

Catalyst reported another record quarter in Q3 2025, with total revenue reaching $148.4 million.

Catalyst 公佈了 2025 年第三季的另一個創紀錄季度業績，總收入達到 1.484 億美元。

An increase of 15.3% year over year.

年增15.3%。

These results were driven primarily by outstanding performance of Fertaps and the growing success of Agamri.

這些成果主要得益於 Fertaps 的出色表現和 Agamri 的日益成功。

Along with extended patient preference for kappa following generic entry.

隨著仿製藥上市，患者對 kappa 的偏好也隨之增強。

We ended the third quarter of 2025 with a cash position of $689.9 million and no debt, further reinforcing our ability to invest strategically for long-term growth.

截至 2025 年第三季末，我們擁有 6.899 億美元的現金儲備，且無任何債務，這進一步鞏固了我們為實現長期成長而進行策略性投資的能力。

Last month we announced that our board of directors authorized a new share buyback program to repurchase up to $200 million of shares of Catalyst's outstanding common stock between October 1st, 2025 and December 31, 2026.

上個月，我們宣布董事會批准了一項新的股票回購計劃，將在 2025 年 10 月 1 日至 2026 年 12 月 31 日期間回購 Catalyst 已發行普通股的至多 2 億美元股份。

As mentioned, we believe that we can execute this share repurchase program without impairing the advancement of our business development strategy.

如前所述，我們相信我們可以在不損害公司業務發展策略推進的情況下執行這項股票回購計畫。

Further, we believe that this repurchase program will enable us to provide value to our shareholders, and we are increasingly confident in our long-term outlook.

此外，我們相信這項回購計畫將使我們能夠為股東創造價值，我們對公司的長期前景也越來越有信心。

With our strong performance over the first three quarters of the year, we are raising our 2025 total revenue guidance to between $565 million and $585 million.

鑑於我們今年前三個季度的強勁表現，我們將 2025 年總營收預期上調至 5.65 億美元至 5.85 億美元之間。

Let's start with FER apps.

我們先從 FER 應用開始。

Birdaps continues to demonstrate outstanding performance, maintaining its position as the only evidence-based approved product in the US for the treatment of Lambert-Eaton Myasthenic syndrome.

Birdaps 繼續展現出卓越的性能，保持著其作為美國唯一獲得循證醫學批准用於治療蘭​​伯特-伊頓肌無力綜合徵的產品的地位。

The brand delivered another strong quarter of sustained growth, generating revenue of $92.2 million an increase of 16.2% year over year.

該品牌又迎來了一個強勁的季度，實現了持續成長，營收達到 9,220 萬美元，較去年同期成長 16.2%。

We are confident that Firdapse remains well positioned for sustained organic growth across both idiopathic and cancer associated limbs markets.

我們相信，Firdapse 在特發性肢體疾病和癌症相關肢體疾病市場中仍將保持良好的有機成長動能。

Supported by a robust pool of patients and individuals progressing through their diagnostic journey.

得到了大量患者和正在經歷診斷過程的個體的支持。

This strong and visible demand underscores the durability of the franchise and reinforces our leadership in addressing the needs of the Lens community.

這種強勁而明顯的需求凸顯了品牌的持久性，並鞏固了我們在滿足 Lens 社群需求方面的領導地位。

Jeff will go into more detail about our growth strategy in these distinct markets in his remarks.

傑夫將在發言中更詳細地闡述我們在這些不同市場的成長策略。

Since we believe that potentially 90% of cancer associated LES patients remain undiagnosed, we see a meaningful opportunity to expand our reach in this high potential underserved population.

由於我們認為可能有 90% 的癌症相關下食道括約肌 (LES) 患者仍未得到診斷，因此我們看到了一個有意義的機會，可以擴大我們在這一極具潛力但服務不足的人群中的服務範圍。

We expect momentum to build in the months ahead, setting the stage for sustained growth in 2026 and beyond.

我們預計未來幾個月成長動能將持續增強，為 2026 年及以後的持續成長奠定基礎。

We remain confident that we'll meet our full year total net product revenue guidance for apps of between $355 million and $360 million.

我們仍有信心實現全年應用程式淨產品總收入目標，即 3.55 億美元至 3.6 億美元。

Jeff will cover the specifics in his section of the call.

傑夫將在電話會議的他的部分詳細介紹情況。

Moving on to a gamma ray While Firdaps continues to perform incredibly well, we're equally encouraged by the market potential and performance of the Gamma.

接下來是伽瑪射線。雖然 Firdaps 的表現依然非常出色，但我們同樣對 Gamma 的市場潛力和性能感到鼓舞。

A gamri continues to outperform expectations, generating $32.4 million in net product revenue in Q3 2025, a 115.2% increase year over year from Q3 2024.

gamri 繼續超越預期，在 2025 年第三季創造了 3,240 萬美元的淨產品收入，比 2024 年第三季年增 115.2%。

These results are largely driven by steady conversion from both prednisone and Emflaza.

這些結果主要得益於潑尼松和恩弗拉扎的穩定轉化。

A strong 90% patient retention rate and growing adoption across virtually all of the DMD centers of excellence around the United States.

高達 90% 的患者留存率，並且在美國幾乎所有 DMD 卓越中心都得到了越來越廣泛的採用。

Agamri's commercial execution continues to track well with strong patient retention and increasing prescriber engagement, further supported by recent full deployment of our dedicated field team back in April.

Agamri 的商業執行情況持續保持良好勢頭，患者留存率高，處方醫生參與度不斷提高，這得益於我們於 4 月份全面部署的專門現場團隊。

Continued transitions from both branded and generic therapies along with growing market receptivity and pair alignment due to an increased appreciation for Agamri's potential differentiation from the current standard of care, reinforce our confidence in raising full year outlook to between $105 and $115 million.

品牌藥和仿製藥的持續轉型，以及市場接受度的提高和對 Agamri 與當前標準療法之間潛在差異化的日益認可，增強了我們對全年預期上調至 1.05 億至 1.15 億美元的信心。

Catalyst continues to actively enroll patients in the Summit study, an open label five-year follow-up study designed to evaluate the long-term clinical safety profile of a gamy, including potential benefits on behavior, stature, bone health, and cardiovascular health.

Catalyst 繼續積極招募患者參與 Summit 研究，這是一項為期五年的開放標籤追蹤研究，旨在評估 gamy 的長期臨床安全性，包括對行為、身高、骨骼健康和心血管健康的潛在益處。

Finally, let's take a look at Phi Kappa.

最後，我們來看看 Phi Kappa 榮譽學會。

BICApa delivered higher than anticipated results in the third quarter of 2025 with revenue of $23.8 million which reflects a year over year decrease of 25.8%. This performance was driven in part by patients electing to stay on their existing treatment plan following generic entry for fikampa tablets in Q2 2025.

BICApa 2025 年第三季業績超出預期，營收為 2,380 萬美元，年減 25.8%。這項業績的部分原因是，在2025年第二季fikampa片劑的仿製藥上市後，患者選擇繼續使用他們現有的治療方案。

Although we anticipate the impact of generic entry to increase going forward as other entrants eventually come to the market, We are raising our full year net product revenue guidance for this product to between $100 and $110 million.

儘管我們預計隨著其他競爭者最終進入市場，仿製藥進入市場的影響將會持續增加，但我們仍將該產品的全年淨產品收入預期上調至 1 億至 1.1 億美元之間。

Now I'd like to reiterate what we believe sets us apart.

現在我想重申一下我們認為讓我們與眾不同的地方。

Catalyst's competitive advantage is built on the strength of not only our field efforts from both our sales and medical teams, but also our patient engagement services that we offer through Catalyst pathways for patients taking FRAs and Agamri.

Catalyst 的競爭優勢不僅建立在我們銷售和醫療團隊的現場努力之上，還建立在我們透過 Catalyst 途徑為服用 FRA 和 Agamri 的患者提供的患者參與服務之上。

Catalyst Pathways is our personalized treatment support program for patients who are enrolled in the program and serves as a single source for personalized treatment support, education, and guidance to the dosing and titration regimen required to reach an effective therapeutic dose for each patient's therapy.

Catalyst Pathways 是我們為參與該計劃的患者提供的個人化治療支援計劃，它為每位患者提供個人化的治療支援、教育和指導，幫助他們確定達到有效治療劑量所需的劑量和滴定方案。

We believe that navigating the healthcare system with this support is far better for patients needing treatment for their rare diseases and for the healthcare community in general.

我們相信，在這種支持下，患者在醫療保健系統中尋求幫助，對於需要治療罕見疾病的患者以及整個醫療保健界來說，都將是更好的選擇。

Finally, our strong relationship with healthcare and rare disease communities continues to drive meaningful stakeholder engagement.

最後，我們與醫療保健和罕見疾病群體之間的牢固關係繼續推動有意義的利害關係人參與。

Together, our single source approach enables the patients we serve to streamline access, identify appropriate therapy, receive timely treatment, and remain compliant with their care.

我們採用一站式服務模式，使我們服務的患者能夠簡化就醫流程，確定合適的治療方案，及時接受治療，並堅持完成治療。

We believe these differentiating differentiating capabilities will enhance prospects for creating uncommon value for our current patients and for other rare disease patients in the future.

我們相信，這些差異化能力將增強我們為現有患者以及未來其他罕見疾病患者創造非凡價值的前景。

Let's turn to business development.

接下來我們來談談業務拓展。

We remain highly disciplined in our business development strategy, and we continue to actively evaluate a broad range of opportunities, many of which are inbounds.

我們在業務發展策略方面保持高度自律，並繼續積極評估各種機會，其中許多是入境機會。

Reflecting growing awareness of the value we create for patients in need.

這反映出人們越來越意識到我們為有需要的患者創造的價值。

We also have an aggressive outreach initiative resulting in over 100 assessments since January. The support services that we have developed through Catalyst Pathways for patients who are taking Vertex and Agamri are industry leading and can be applied to any rare therapeutic area.

我們也積極進行推廣活動，自一月以來已進行了 100 多次評估。我們透過 Catalyst Pathways 為服用 Vertex 和 Agamri 的患者開發的支援服務是業界領先的，可以應用於任何罕見疾病治療領域。

So we remain therapeutic area agnostic.

因此，我們保持治療領域中立。

We believe our integrated infrastructure with our sales teams identifying potential patients and catalyst pathways providing direct support to patients, getting the patients on therapy, keeping them on therapy, and ensuring the patient receives the optimum dose are important components of our continued success and our core capabilities that we see as not universally available through other companies serving patients living with rare diseases.

我們相信，我們整合的基礎設施，包括銷售團隊識別潛在患者和催化途徑，為患者提供直接支持，幫助患者接受治療，堅持治療，並確保患者獲得最佳劑量，這些都是我們持續成功和核心能力的重要組成部分，而我們認為其他服務於罕見病患者的公司並不普遍具備這些能力。

Now for an update on IP.

現在來了解IP的最新情況。

We continue continue to advance initiatives to protect long-term value for our portfolio.

我們將繼續推動各項舉措，以保護我們投資組合的長期價值。

On August 20th, we announced the settlement of our pending for Epps patent litigation with Lupin.

8 月 20 日，我們宣布與 Lupin 就 Epps 專利訴訟達成和解。

As part of the settlement, Lupin received a license to market generic faps beginning in February of 2035.

作為和解協議的一部分，Lupin 獲得了從 2035 年 2 月開始銷售仿製藥的許可。

On the same market entry date as Teva Pharmaceuticals had previously agreed to in their settlement.

與梯瓦製藥先前在和解協議中約定的市場准入日期相同。

This settlement leaves only one patent case still pending against Hetero USA Incorporated.

這項和解協議使得針對 Hetero USA Incorporated 的專利訴訟案僅剩一起待決案件。

The trial date has been set for March of 2026, which is prior to the expiration of the automatic 30 month stay.

審判日期定於 2026 年 3 月，這早於 30 個月自動中止期的到期日。

Set for May 20th of 2026.

預定2026年5月20日。

I'd like to reiterate my previous comment, as we have consistently stated, we will vigorously defend our IP for all of our products.

我想重申我先前的評論，正如我們一直聲明的那樣，我們將堅決捍衛我們所有產品的智慧財產權。

With that, I'll turn the call over to Jeff, who can provide additional insights into our commercial performance. Jeff.

接下來，我將把電話交給傑夫，他可以提供更多關於我們商業表現的見解。傑夫。

Thanks, Rich. Q3 2025 marked another record setting quarter for a commercial organization, generating net product revenue of $148.4 million, a 17.4% increase compared to Q3, 2024.

謝謝你，里奇。2025 年第三季度，商業機構再次創下季度紀錄，淨產品收入達 1.484 億美元，比 2024 年第三季成長 17.4%。

These results highlight continued strong execution across our portfolio and sustained demand for our differentiated therapies, as Rich noted, Catalyst again delivered organic growth from Ferdas, continued adoption of a gammari, and stronger than expected revenue from PCampa.

這些結果凸顯了我們產品組合的持續強勁執行力以及對我們差異化療法的持續需求，正如 Rich 指出的那樣，Catalyst 再次從 Ferdas 實現了內生增長，繼續採用 gammari，並且 PCampa 的收入也高於預期。

Our Q3 2025 net product revenue underscores the strength and resilience. Of our rare disease platform.

我們 2025 年第三季的淨產品收入凸顯了公司的實力和韌性。我們的罕見疾病平台。

FRAs continues to deliver sustained organic growth. Q3 2025 revenue, results of $92.2 million reflect its robust growth trajectory driven by durable demand and continued execution of our growth strategy, resulting in 16.2% growth in Q3 2025 compared to Q3 2024.

遠期匯率協議持續實現內生成長。2025 年第三季營收為 9,220 萬美元，反映了公司強勁的成長勢頭，這得益於持續的需求和成長策略的持續執行，與 2024 年第三季相比，2025 年第三季成長了 16.2%。

New patient enrollments exceeded forecast. Prescription approval rates remained above 90% across both government and commercial payers, and discontinuation rates were in line with expectations, tracking below an annualized rate of 20%.

新患者登記人數超乎預期。政府和商業支付方的處方批准率均維持在 90% 以上，停藥率符合預期，年化率低於 20%。

These indicators reflect strong patient adherence and reinforce the foundation for sustained performance.

這些指標反映了患者良好的依從性，並為持續的療效奠定了基礎。

Leading indicators, including new patient starts and refill volumes through October, continue to trend positively, reinforcing our confidence in achieving our full year 2025 FERDA's net product revenue guidance of between $355 million and $360 million.

包括截至 10 月的新患者開戶量和續藥量在內的領先指標持續呈現正面趨勢，增強了我們對實現 2025 年全年 FERDA 淨產品收入指導目標（3.55 億美元至 3.6 億美元）的信心。

Our next phase of growth for FERS will come from both idiopathic limbs and cancer associated limbs. For idiopathic limbs, we continue to advance our patient identification efforts by augmenting data sources, further expanding the pool of over 500 LEMs patients in active diagnostic stages.

FERS 的下一階段增長將來自特發性肢體和癌症相關肢體。對於特發性肢體，我們透過增加資料來源來繼續推進患者識別工作，進一步擴大了處於活躍診斷階段的 500 多名 LEM 患者的數量。

With a dedicated sales force of 16 regional account managers and enhanced lead optimization efforts that better target patients most likely to initiate Verap's treatment, these patients now represent over 50% of new starts each quarter, strengthening our confidence in sustaining future organic growth.

我們擁有一支由 16 名區域客戶經理組成的專業銷售團隊，並加強了潛在客戶優化工作，以更好地鎖定最有可能開始接受 Verap 治療的患者。這些患者現在佔每季新開始治療患者的 50% 以上，增強了我們對未來持續自然成長的信心。

In addition, we have intensified efforts to expand VGCC antibody testing among patients often misdiagnosed with myasthenia gravis, which remains the most common misdiagnosis for LEMS patients. We have seen sustained VGCC antibody testing growth of 9% quarter on quarter over the last two years, with only approximately 30% penetration on the idiopathic side of the lens market opportunity.

此外，我們加強了對常被誤診為重症肌無力的患者進行VGCC抗體檢測的力度，重症肌無力仍是LEMS患者最常見的誤診。在過去的兩年裡，我們看到 VGCC 抗體檢測持續成長，每季成長 9%，但在特發性晶狀體市場機會方面，滲透率僅約為 30%。

We have clearly identified the potential sustainable growth.

我們已經明確了潛在的可持續成長點。

Our expansion strategy for cancer associated LEMS is sharply focused on multiple critical levers, broadening access to BGCC antibody testing and streamlining the diagnostic pathway, now further reinforced by the recent NCCN small cell lung cancer guideline update on July 25th, and our efforts to update the oncology care pathways and expanding HCP education. On those updated pathways, as Rich mentioned, we are continuing to execute on those fronts.

我們針對癌症相關 LEMS 的擴展策略重點關注多個關鍵槓桿，擴大 BGCC 抗體檢測的覆蓋範圍並簡化診斷途徑，而 7 月 25 日 NCCN 小細胞肺癌指南的更新進一步強化了這一戰略，同時我們也在努力更新腫瘤護理途徑並擴大 HCP 教育。正如 Rich 所提到的，我們正在繼續推進這些更新後的路徑。

First, we have launched a frictionless testing model designed to remove referral bottlenecks and accelerate the time to diagnosis.

首先，我們推出了一種無摩擦檢測模式，旨在消除轉診瓶頸，並加快診斷速度。

Second, the updated NCCN guidelines now include VGCC antibody testing and recommend amifarinine, the only evidence-based approved treatment for patients with LEMS, potentially providing a strong tailwind for market adoption.

其次，更新後的 NCCN 指南現在包括 VGCC 抗體檢測，並推薦阿米法林，這是唯一獲得實證醫學批准的 LEMS 患者治療方法，這可能為市場採用提供強大的推動力。

Third, we are pursuing new collaborations with leading oncology networks to integrate these updated NCCN guidelines into their care pathways.

第三，我們正在尋求與領先的腫瘤網絡進行新的合作，將這些更新的 NCCN 指南整合到他們的護理路徑中。

Lastly, we continue to expand our footprint across the community to educate those concentrated oncology centers on the updated care pathways.

最後，我們將繼續擴大在社區的影響力，向那些集中治療腫瘤的中心普及最新的治療方案。

With over 90% of cancer LEMS patients still undiagnosed, the unmet need remains significant. We see a clear opportunity to drive awareness, increase access, and deliver meaningful impact across the LEMS community.

超過 90% 的癌症 LEMS 患者仍未確診，未滿足的需求仍然很大。我們看到了一個明確的機會，可以提高人們對 LEMS 群體的認識，增加獲取途徑，並產生有意義的影響。

As we move forward, we're executing with precision to accelerate diagnosis, increase adoption, and position FERTDAs for sustained momentum through 2026 and beyond.

展望未來，我們將精準執行，加快診斷速度，提高普及率，並使 FERTDA 在 2026 年及以後保持持續發展勢頭。

Turning to Agamri continues to demonstrate strong market momentum as a differentiated therapy for Duchenne muscular dystrophy.

轉向 Agamri 繼續展現出強勁的市場勢頭，成為治療杜氏肌肉營養不良症的差異化療法。

In the third quarter of 2025, we generated net product revenue of $32.4 million a 115.2% increase over the third quarter of 2024.

2025 年第三季度，我們的淨產品收入為 3,240 萬美元，比 2024 年第三季度成長了 115.2%。

Adoption is expanding steadily across key treatment centers. To date, each of the TOP45 DMD centers of excellence have enrolled at least one patient on a gammari, and 255 unique healthcare providers have submitted enrollment forms reflecting broad and growing engagement across the community.

在各主要治療中心，採用率正穩定提高。迄今為止，TOP45 DMD 卓越中心均已招募至少一名患者參加 gammari 計劃，255 位不同的醫療保健提供者已提交註冊表格，這反映出社區參與度的廣泛性和不斷提高。

Since launch, approximately 43% of patients being treated with Agamri transitioned from prednisone and 41% from Enflaza, highlighting Agamri's broad clinical relevance across established treatment segments.

自上市以來，約 43% 的 Agamri 治療患者是從潑尼松過渡而來，41% 的患者是從 Enflaza 過渡而來，這凸顯了 Agamri 在已建立的治療領域中廣泛的臨床相關性。

Reimbursement performance remains robust with success rates above 85% in line with our expectations. Our commercial team continues to execute effectively, driving targeted provider education and deepening payer engagement to support durable uptake and sustained market expansion.

報銷情況依然穩健，成功率超過 85%，符合我們的預期。我們的商業團隊繼續有效執行，推動有針對性的供應商教育，並加深與支付方的合作，以支持持久的市場接受度和持續的市場擴張。

Given the continued strength of these trends, we are raising our full year net product revenue guidance for Agamri to a range of between $105 million and $115 million.

鑑於這些趨勢的持續強勁，我們將 Agamri 的全年淨產品收入預期上調至 1.05 億美元至 1.15 億美元之間。

Finally, FICApa delivered Q3 2025 net product revenue of $23.8 million, reflecting continued demand following the first generic entry for tablets in late May.

最後，FICApa 公佈了 2025 年第三季淨產品收入為 2,380 萬美元，反映出自 5 月下旬首個片劑仿製藥上市以來持續的需求。

We remain cautiously optimistic on FY Kapa brand loyalty and based on stronger than expected performance in the 1st 9 months, we are raising full year 2025 FCampa revenue guidance to between $100 and $110 million.

我們對 Kapa 品牌忠誠度的前景保持謹慎樂觀，並且基於前 9 個月強於預期的表現，我們將 2025 年全年 FCampa 收入預期上調至 1 億至 1.1 億美元之間。

As previously noted, we do expect continued revenue erosion from generic competition to impact FO performance in Q4 and beyond as more generics enter the market.

如前所述，隨著更多仿製藥進入市場，我們預計仿製藥競爭帶來的持續收入侵蝕將在第四季度及以後對 FO 的業績產生影響。

In summary, our commercial team continues to execute with strong discipline and focus, delivering robust portfolio performance and advancing our next phase of growth.

總而言之，我們的商業團隊繼續以高度的紀律性和專注度執行，實現了穩健的投資組合業績，並推進了我們下一階段的成長。

We are confident that our diversified portfolio, best in class commercial capabilities, and focused execution position us well to capture the significant growth opportunities ahead.

我們相信，憑藉我們多元化的產品組合、一流的商業能力和專注的執行力，我們能夠很好地掌握未來巨大的成長機會。

As we look to close 2025, our priorities remain clear.

展望2025年，我們的工作重點依然明確。

Driving commercial excellence, broadening patient access, and maximizing the value of our portfolio to deliver sustainable growth and long-term shareholder value.

推動商業卓越發展，擴大患者獲取途徑，並最大限度地發揮我們產品組合的價值，以實現可持續增長和長期股東價值。

I would like to thank the entire Catalyst team for their continued dedication and commitment to performance, execution, and the patients we serve.

我要感謝 Catalyst 團隊全體成員，感謝他們一直以來對績效、執行力和我們所服務的患者所做的奉獻和承諾。

At this time, I would like to turn the call back over to Mike.

此時，我想把電話轉回給麥克。

Thank you, Jeff. Our performance during the 3rd quarter of 2025 has kept us on pace for another strong year, driven by our solid financial performance, financial discipline, and strong execution.

謝謝你，傑夫。在穩健的財務表現、財務紀律和強有力的執行力的推動下，我們在 2025 年第三季的出色表現使我們有望再創佳績。

Our total revenues for the third quarter of 2025 were $148.4 million an approximate 15.3% increase when compared to total revenues of $128.7 million for the third quarter of 2024.

2025 年第三季總營收為 1.484 億美元，與 2024 年第三季總營收 1.287 億美元相比，成長約 15.3%。

The third quarter of 2024 included approximately $2.3 million of license and other revenue, which consisted principally of a milestone payment that we earned from our sub licensee, Dido Pharma, upon its receiving regulatory approval to commercialize Firdapse for the treatment of patients with LEMS in Japan, compared to license and other revenue in the third quarter of 2025 of $27,000.

2024 年第三季包括約 230 萬美元的許可和其他收入，其中主要包括我們從分許可方 Dido Pharma 獲得的一筆里程碑付款，該付款是 Dido Pharma 獲得監管部門批准在日本將 Firdapse 商業化用於治療 LEMS 患者後支付的。相比之下，2025 年第三季的授權和其他收入為 2.7 萬美元。

Net income before income taxes for the third quarter of 2025 were $71.0 million a 24.2% increase year over year compared to $57.2 million for the third quarter of 2024.

2025 年第三季稅前淨收入為 7,100 萬美元，比 2024 年第三季的 5,720 萬美元成長了 24.2%。

We reported GAAP net income for the third quarter of 2025 of $52.8 million or $0.42 per diluted share.

我們公佈了 2025 年第三季的 GAAP 淨收入為 5,280 萬美元，即每股攤薄收益 0.42 美元。

GAAP net income increased by 20.3% year over year compared to GAAP net income for the third quarter of 2024 of $43.9 million or $0.35 per diluted share.

與 2024 年第三季 GAAP 淨利 4,390 萬美元或每股攤薄收益 0.35 美元相比，GAAP 淨利潤年增 20.3%。

Non-GAAP net income for the third quarter of 2025 was $86.1 million or $0.68 per diluted share, which excludes firm GAAP net income, amortization of intangible assets related to our acquisitions of FCampa, Agamri and Resergi of $9.3 million stock based compensation expense of $5.7 million the income tax provision of $18.3 million and depreciation of $100,000.

2025 年第三季非 GAAP 淨收入為 8,610 萬美元，即每股攤薄收益 0.68 美元，不包括公司 GAAP 淨收入、與收購 FCampa、Agamri 和 Resergi 相關的無形資產攤銷 930 萬美元、股票選擇權費用 570 萬美元、所得稅費用 1,830 萬美元。

This compares to non-GAAP net income for the third quarter of 2024 of $71.1 million or $0.57 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of PCampa, Agari, and Resurgi of $9.3 million stock-based compensation expense of $4.4 million the income tax provision of $13.3 million and depreciation of $100,000.

相比之下，2024 年第三季的非 GAAP 淨收入為 7,110 萬美元，即每股攤薄收益 0.57 美元。 GAAP 淨收入不包括與我們收購 PCampa、Agari 和 Resurgi 相關的無形資產攤銷 930 萬美元、股票選擇權費用 440 萬美元、所得稅準備金 1,330 萬美元和折舊 10 萬美元。

Our year-to-date effective tax rate through the first nine months of 2025 was 23.6% compared to 24.0% through the first nine months of 2024.

截至 2025 年前九個月，我們的實際稅率為 23.6%，而截至 2024 年前九個月，我們的實際稅率為 24.0%。

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.

實際稅率受多種因素影響，包括特定期間內行使的股票選擇權數量，並且未來可能會出現波動。

Costs of sales expense was approximately $22.7 million in the third quarter of 2025 compared to $19.3 million in the third quarter of 2024 and consisted principally of royalties.

2025 年第三季的銷售成本約為 2,270 萬美元，而 2024 年第三季為 1,930 萬美元，主要包括特許權使用費。

As a reminder, the Gambi royalties paid to the product licensor equal 5% of net sales up to $100 million for 2025. And 7% of net sales in excess of $100 million and up to $200 million with additional increases as net sales increase.

提醒一下，Gambi 向產品授權人支付的版稅相當於淨銷售額的 5%，最高可達 1 億美元（2025 年）。淨銷售額超過 1 億至 2 億美元部分的 7%，隨著淨銷售額的成長，該比例還會增加。

The company is also required to make a $12.5 million sales-based milestone payment once the GAR's net product revenue for a fiscal year reaches $100 million. When this occurs, this milestone payment will be capitalized and advertised over the estimated remaining useful life of the asset.

當 GAR 的財政年度淨產品收入達到 1 億美元時，該公司還需支付 1,250 萬美元的銷售里程碑付款。當這種情況發生時，這筆里程碑付款將被資本化，並在資產的預計剩餘使用壽命內進行揭露。

Further Further details on our royalty obligations for GAR, as well as Firdapse and FCampa, are disclosed in our third quarter Form 10 Q.

有關我們對 GAR 以及 Firdapse 和 FCampa 的特許權使用費義務的更多詳細信息，請參閱我們第三季度的 10-Q 表格。

Research and development expenses were $2.7 million in the third quarter of 2025 compared to $3.3 million in the third quarter of 2024.

2025 年第三季的研發費用為 270 萬美元，而 2024 年第三季為 330 萬美元。

Our R&D spending in the third quarter of 2025 was comprised mainly of costs to support our two ongoing AAAR studies.

我們在 2025 年第三季的研發支出主要包括支持我們正在進行的兩項 AAAR 研究的成本。

Selling general and administrative or SG&A expenses for the third quarter of 2025 totaled $47.5 million as compared to $45.9 million in Q3 2024, reflecting in part an increase in our cancer associated LEMs and activities.

2025 年第三季銷售一般及行政費用或 SG&A 費用總計 4,750 萬美元，而 2024 年第三季為 4,590 萬美元，部分原因是與癌症相關的 LEM 和活動增加。

As reported, we ended the third quarter of 2025 with cash in cash equivalents of $689.9 million compared to $517.6 million at December 31, 2024.

據報道，截至 2025 年第三季末，我們的現金及現金等價物為 6.899 億美元，而截至 2024 年 12 月 31 日為 5.176 億美元。

This increase in cash of $172.3 million between the end of 24 and September 30, 2025 was largely driven by $163.8 million in cash generated from operations of the business.

從 2024 年底到 2025 年 9 月 30 日，現金增加了 1.723 億美元，這主要是由於公司經營活動產生的現金增加了 1.638 億美元。

This highlights our continued focus on profit optimization and cash flow generation.

這凸顯了我們對利潤優化和現金流創造的持續關注。

We believe our current funds, along with our expected continued generation of cash from operations 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 ex expansion efforts leading to long-term growth and value creation.

我們相信，我們目前的資金，加上我們預期持續從營運中產生的現金，將繼續使我們擁有財務靈活性，為現有的研發項目提供資金，履行潛在的合約義務，並支持我們的戰略舉措、業務發展和投資組合擴張工作，從而實現長期增長和價值創造。

More detailed information and analysis of our 3rd quarter 2025 financial performance may be found in our quarterly report on Form 10 Q, which was filed with the Securities and Exchange Commission yesterday, November 5th, and can be found on the investor relations web page of our website.

有關我們 2025 年第三季財務業績的更詳細資訊和分析，請參閱我們昨天（11 月 5 日）向美國證券交易委員會提交的 10-Q 表格季度報告，該報告可在我們網站的投資者關係網頁上找到。

At this time, I will turn the call back over to Rich.

此時，我將把通話轉回給里奇。

Rich, thanks, Mike. As you heard on today's call, Catalyst is closing 2025 with strong momentum and an unwavering commitment to deliver value for the patients we serve.

Rich，謝謝你，Mike。正如您在今天的電話會議上聽到的那樣，Catalyst 將在 2025 年末保持強勁的發展勢頭，並堅定不移地致力於為我們服務的患者創造價值。

This confidence is reflected in our updated guidance which we raised after careful consideration and with respect to market conditions.

這種信心體現在我們經過仔細考慮並結合市場狀況後發布的最新業績指引中。

This quarter's exceptional results reflect the strength of our commercial execution, the resilience of our business model, and the depth of talent across our organization.

本季取得的優異業績反映了我們強大的商業執行力、我們商業模式的韌性以及我們整個組織深厚的人才儲備。

I want to thank our employees, partners, and shareholders for their continued support and dedication.

我要感謝我們的員工、合作夥伴和股東們一直以來的支持和奉獻。

As we finish 2025 with ongoing momentum, we look forward to continued success.

2025 年即將結束，我們將繼續保持強勁的發展勢頭，期待未來能取得更大的成功。

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

感謝您參加今天的電話會議，現在我將把電話轉回給接線員，回答您的問題。

(Operator instruction)

（操作說明）

Samantha Semenko from Citi group.

來自花旗集團的 Samantha Semenko。

Hi, good morning. Thanks very much for taking our questions. And congratulations on the great quarter. 1st question is on Fred apps. I'm wondering, as you start to penetrate and really put a lot of effort into the oncology portion of the lens business, are you able to share any anecdotes or data points that you have thus far that can really help us begin to quantify how those efforts are progressing? And then on Fcompa, do you have a sense of what proportion of the patients are expected to stay loyal to branded Fycompa?

您好，早安。非常感謝您回答我們的問題。恭喜你們本季業績出色。第一個問題是關於Fred應用程式的。我想問的是，隨著您開始深入並真正投入大量精力到隱形眼鏡業務的腫瘤學領域，您能否分享一些您迄今為止掌握的軼事或數據點，以便真正幫助我們開始量化這些努力的進展情況？那麼，關於 Fcompa，您認為預計有多少比例的患者會繼續忠於品牌藥 Fycompa 呢？

You're just trying to figure out if these additional generics come to the market, and how much erosion we're looking at for this 4th quarter.

你只是想弄清楚這些額外的仿製藥是否會進入市場，以及第四季度我們將面臨多大的市場份額下滑。

Thanks very much.

非常感謝。

Thanks for the question, SAM. For the first one, I'll turn it over to Jeff. Jeff, you want to give us some update.

謝謝你的提問，SAM。第一個問題，我交給傑夫回答。傑夫，你想為我們報告一下最新情況嗎？

Hi SAM. Good morning. As far as the cancer associated lens and providing maybe some anecdotes or leading indicators on how performance is going, we will do that in future quarters. What we're, continuing to do is, like we mentioned on the earnings call, the, our first goal was really to get that testing in place, which we were successful. Secondly, the updates to the NCCN guidelines, which, again, we were also very successful in doing that. Last July, so very pleased with that. Currently, what we're doing is we're educating and working on, educating physicians in group practices and, hopefully, partnering with them to change their care pathways and also, have screening arrangements put in place. Moving forward, when we are successful with those discussions and those partnerships, we will share some of the leading indicators.

嗨，SAM。早安.至於與癌症相關的分析，以及提供一些軼事或有關業績進展的先行指標，我們將在未來的幾個季度進行探討。正如我們在財報電話會議上提到的那樣，我們將繼續努力，我們的首要目標是落實測試工作，而我們已經成功地做到了這一點。其次，我們對 NCCN 指南進行了更新，在這方面我們也取得了巨大的成功。去年七月，所以對此非常滿意。目前，我們正在對團體診所的醫生進行教育和培訓，並希望與他們合作，改變他們的護理路徑，並制定篩檢安排。展望未來，當我們成功地進行這些討論並建立這些合作關係時，我們將分享一些領先指標。

So, to build on that, as well, Oncology is a highly structured and complex marketplace and so since the NCCN guidelines, which actually gives us the opportunity or license if you will, to begin those discussions, we got that back at the end of July. And we're really excited about the conversations we're having with the decision makers in the oncology marketplace. It is a process. We are working through it and we expect, as we've said in the past, that that will deliver results in 2026.

因此，在此基礎上，腫瘤學是一個高度結構化和複雜的市場，自 NCCN 指南發布以來，我們獲得了開始這些討論的機會或許可，我們在 7 月底收到了該指南。我們非常高興能與腫瘤市場決策者進行對話。這是一個過程。我們正在努力解決這個問題，正如我們過去所說，我們預計這將在 2026 年取得成果。

Okay, I'm just going to move on to your next question, if that's okay.

好的，那我直接跳到你的下一個問題了，可以嗎？

Yes, so Jeff, the Phi Kappa stickiness, any thoughts on that? Sure.

是的，傑夫，關於Phi Kappa的黏性問題，你有什麼看法？當然。

So as you see by the revenue, numbers that we've reported, Phi Kappa is, continues to perform very well.

正如您從我們公佈的收入數據中看到的那樣，Phi Kappa 的表現仍然非常出色。

And we do believe a lot of that is from brand loyalty and the stickiness. As, additional generics enter the market later this year, we do expect, additional erosion to revenue. However, we do also expect some patients to remain loyal to the brand. As far as a specific percentage, we haven't really provided guidance on that. And we're very confident in our guidance that we did provide for That.

我們相信這很大程度源自於品牌忠誠度和用戶黏性。隨著更多仿製藥在今年稍後進入市場，我們預計收入將進一步下降。然而，我們也預期部分患者會繼續忠於該品牌。至於具體的百分比，我們還沒有給出明確的指導意見。我們對我們所提供的指導非常有信心。

very helpful. Thanks for taking the questions.

很有幫助。謝謝您回答問題。

June Lee from Trua Security.

來自 Trua Security 的 June Lee。

Congrats on a strong quarter and thanks for taking the questions. This is an awesome one for June, just a couple from us, just on the 5 comppa stickiness, why are patients choosing to stay on Fycompa longer? What are you hearing from them? And, can you remind us how many generics are currently in the market and how many we could expect by year end? And then just on for that, are you actively seeing oncology practices following the updated NCCN guidelines, or would you say that's more of a 2026 story?

恭喜你們本季業績出色，感謝你們回答問題。這是六月的一篇很棒的文章，我們只寫了兩篇，關於 5 號 Comppa 的粘性，為什麼患者選擇繼續服用 Fycompa 更長時間？你從他們那裡聽到了什麼消息？另外，您能否提醒我們一下目前市場上有多少種仿製藥，以及到年底我們預計會有多少種？那麼，就這一點而言，您是否積極看到腫瘤科實踐遵循更新後的 NCCN 指南，還是您認為這更像是 2026 年才會發生的事情？

Thank you.

謝謝。

I'm sorry, could you just repeat the second question? I just lost you for a second.

抱歉，您能再說一次第二個問題嗎？我剛才沒看到你。

Yeah, just on for apps, are you actively seeing oncology practices following the updated guidelines, or is that more of a 2026 Story?

是的，就應用程式而言，您是否積極看到腫瘤科診所遵循更新後的指南，還是說這更像是 2026 年才會發生的事情？

Thank you. Jeff, on the stickiness, obviously, P Kapa is a one of one. In the marketplace, and then we have one generic in there. So, do you want to speak to the potential stickiness?

謝謝。Jeff，說到黏性，顯然，P Kapa 是獨一無二的。在市場上，我們有一種仿製藥。那麼，你想談談潛在的黏性問題嗎？

Sure. So, when you take a look at, the generic, competition right now for Vikampa, there's one, and that's Teva. That, Teva's generic is at about a 17 plus, discount to Vikompa. So, it's a relatively, good market for us, when competing against Tevas, Product. The stickiness, a lot of patients, are afraid that, to switch medications for, antiseizure medications. What they don't want is something where a generic, one month and then, it's different, so that they have a breakthrough seizure. So, one of the things that they like to do is stay on the brand that they've been on for the last 10-12 plus years. So, That lends to the stickiness of the product. Also, we still have, field personnel, for Vikampa that are out there talking to many of the physicians that prescribe antiseizure medications and financial resources, to help patients that are on Vikampa. So, I think all those things contribute to the stickiness, and that's what we've seen in our, in the revenue that we reported. Does that answer your question about Viampa?

當然。所以，當你查看 Vikampa 目前的主要競爭對手時，你會發現只有一個，那就是 Teva。Teva 的仿製藥比 Vikompa 便宜約 17 倍以上。所以，在與 Tevas 產品競爭時，這對我們來說是一個相對不錯的市場。很多患者都害怕藥物黏性，擔心換用抗癲癇藥物。他們不希望看到的是，一種通用藥物，服用一個月後，情況就不同了，導致癲癇發作復發。所以，他們喜歡做的一件事就是繼續使用他們過去 10 到 12 年甚至更長的時間來品牌。所以，這導致了產品的黏性。此外，我們還有 Vikampa 的現場工作人員，他們正在與許多開立抗癲癇藥物的醫生交談，並提供經濟資源，以幫助正在服用 Vikampa 的患者。所以，我認為所有這些因素都有助於提高用戶黏性，而這正是我們在公佈的收入中所看到的。這樣回答了你關於Viampa的問題嗎？

Yeah okay, great. And as far as the NCCN guidelines and, the adoption of those, we, it is more of a, 2026, part of our 2026, that's when we'll see more of the adoption. But it is, significant in our discussions with these group practices in, getting the care pathways changed and to adopt, the NCCN guidelines. So we're starting to see those discussions pay off, but again, our, Goal for 2025 and the remainder of this year is really to accelerate screening, for these patients, which will turn into hopefully patients that will be diagnosed with small cell lung cancer LEMS next year and then also transition to com, or, to, BRAS.

好的，太好了。至於 NCCN 指南及其採納，我們預計到 2026 年，也就是我們 2026 年的一部分時間，屆時我們將看到更多採納。但對於我們與這些團體診所的討論而言，改變護理路徑並採納 NCCN 指南具有重要意義。所以我們開始看到這些討論取得了成效，但是，我們2025年和今年剩餘時間的目標是真正加快對這些患者的篩檢，希望明年能診斷出患有小細胞肺癌LEMS的患者，然後過渡到治療BRAS。

Thanks, Jeff.

謝謝你，傑夫。

Leland Gerel from Oppenheimer.

奧本海默的利蘭·傑雷爾。

Hey guys, it's Rohan on for Leland. Congrats on another strong quarter. I wanted to ask on agamri if you've seen any changes in the prescriber base. It's been talked about before how as people get more acquainted with longer-term data from agamri and, real world data.

大家好，我是羅漢，今天替利蘭上線。恭喜又一個季度業績出色。我想在 agamri 上詢問一下，你們是否發現處方醫生群體有任何變化。之前已經討論過，隨著人們越來越熟悉 agamri 的長期數據和真實世界數據，情況會如何變化。

More prescribers may be inclined to come on and, give their patients agamre. Have you seen any change in the breakdown? There are any, new prescribers and more so on a gamri.

可能會有更多處方醫生傾向於加入，並給他們的病人開阿加姆雷。你發現故障率有任何變化嗎？有很多新的處方醫生，而且在 gamri 上更是如此。

Just given the scope of what the differentiated steroid can do, are you exploring any other opportunities outside of Duchenne?

鑑於這種差異化類固醇的作用範圍之廣，您是否正在探索杜氏肌肉營養不良症以外的其他治療機會？

And yeah, that's all for me.

好了，我今天就說這些。

Well, thanks for the question. Jeff, do you want to handle first? Sure. So.

謝謝你的提問。傑夫，你想先處理嗎？當然。所以。

For a GAR, we're extremely pleased with how the launch has gone thus far, over the last year and a half plus. And we have seen strong adoption. And like I mentioned, the TOP45 centers of excellence for Duchenne muscular dystrophy make up about 80% of the steroid prescriptions for, boys living with DMD. And each of the TOP40, have enrolled at least one patient on a gamma. So, that's strong adoption there. When you take a look at the TOP100 centers of excellence, we have over 95% penetration in those markets, in those centers of excellence. So, again, broad adoption. And then also we've talked about the adoption across both segments of prednisone as well as Imflaza. So, very confident and pleased with that performance, Thus far, and also the 257 healthcare providers that have prescribed, Agamray, at least one patient on agamray. So, again, strong adoption. Now what our focus is to continue to deepen that adoption, so that we can get more and more patients within each center on a gamy as these physicians see the differentiation of a gammaray versus the other steroids. So, that, that's our goal moving forward.

對於一家全球汽車零售商 (GAR) 來說，我們對過去一年半以來的上市情況感到非常滿意。我們看到了強勁的市場接受度。正如我之前提到的，杜氏肌肉營養不良症排名前 45 名的卓越中心為患有 DMD 的男孩開出了約 80% 的類固醇處方。前 40 名中的每家都至少招募了一名患者參與伽瑪療法。所以，那裡的市場接受度很高。當你查看前 100 名卓越中心時，你會發現我們在這些市場和這些卓越中心的滲透率超過 95%。所以，再次強調，廣泛採用至關重要。此外，我們也討論了潑尼松和英夫利西單抗在兩個細分市場中的應用。所以，我對目前的表現非常有信心和滿意，而且已有 257 位醫療保健提供者為至少一位患者開立了 Agamray 處方。所以，再次證明，市場接受度很高。現在我們的重點是繼續深化這種應用，以便讓每個中心越來越多的患者接受伽瑪射線治療，因為這些醫生看到了伽瑪射線與其他類固醇的差異。所以，這就是我們接下來的目標。

On the second question, regarding additional opportunities beyond Duchenne's, first, we'll turn it over to Will Andrews, our Chief Medical Officer. Will?

關於第二個問題，即除了杜氏肌肉營養不良症之外的其他機會，首先，我們將把這個問題交給我們的首席醫療官威爾·安德魯斯來回答。將要？

Yes, hello, thank you, Rich.

是的，你好，謝謝你，里奇。

We are evaluating life cycle management opportunities for consideration of add-on indications for a gamri, and as an example You Can Imagine We look at disorders that have muscle inflammation that significantly affect function in patients and even other inflammatory disorders. So we are actively evaluating life cycle management opportunities.

我們正在評估生命週期管理機會，以考慮為 gamri 添加適應症，例如，您可以想像，我們研究肌肉發炎嚴重影響患者功能的疾病，甚至其他發炎性疾病。因此，我們正在積極評估生命週期管理的機會。

Thanks, and I would just emphasize that our life cycle opportunities are focused in the rare space, so we want to continue with the profile that we have with the product. So we're really excited about the things we're exploring right now, and, we'll probably be addressing those in future, on future calls.

謝謝，我只想強調一下，我們的生命週期機會集中在稀有領域，所以我們希望繼續保持我們目前的產品定位。所以，我們對目前正在探索的事物感到非常興奮，而且，我們可能會在未來的電話會議上討論這些問題。

Thank you.

謝謝。

Pavi Patel from Bank of America.

來自美國銀行的帕維·帕特爾。

Hey guys, thanks for taking my questions. The first one is Ana Gamry.

各位好，感謝你們回答我的問題。第一個是安娜·加姆裡。

I believe you mentioned that you've reached nearly all of the DMD centers of excellence. So maybe if you can provide some more color on the depth of prescribing versus breadth, and what feedback are you getting from physicians and payers about the profile and what do you see as the main hurdle to full conversion, in this patient population.

我相信您曾經提到您已經拜訪過幾乎所有的DMD卓越中心。所以，如果您能更詳細地說明處方深度與廣度之間的關係，以及您從醫生和支付方那裡得到的關於該概況的反饋，以及您認為在這個患者群體中實現完全轉化的主要障礙是什麼，那就太好了。

And then on for apps just, the growth is pretty strong on a year over year basis, and you reaffirmed your full year guidance for that product rather than raising it so. That sort of implies a sequential, slowdown. Just wondering if this reflects conservatism or are you anticipating, that true slowdown in 4Q? And can you elaborate on which growth driver, whether it's new patients, enhanced dosing, or persistence is contributing the most to your year over year growth?

至於應用程式方面，其年增長相當強勁，你們重申了該產品的全年業績預期，而不是上調預期。這暗示著一種循序漸進的放緩。我想知道這反映的是保守主義，還是您預計第四季會出現真正的放緩？您能否詳細說明一下，無論是新患者、劑量增加或患者堅持治療，哪一項成長驅動因素對貴公司逐年成長的貢獻最大？

Thank you.

謝謝。

Thanks,

謝謝，

Yes, for, yeah.

是的，沒錯。

So, I'm sorry, I just, we were just clarifying your second question, and we'll come back to that. Jeff, do you want to handle the first one on centers of excellence and depth and breadth?

抱歉，我們剛才只是在澄清你的第二個問題，稍後我們會再討論這個問題。傑夫，你想負責第一個關於卓越中心、深度和廣度的議題嗎？

Sure. So, very good question. And it truly does vary across, all the centers of excellence. What's very unique about Duchenne muscular dystrophy is one center of excellence, is, far different from the next one. So, There's not one uniform way that they prescribe, steroids for their boys living with DMD. So, we have, many of these centers with multiple patients on it, like 10-20, and in some cases, many more than that, or much more than that. And then we have, other centers that, only have a handful of patients. So, that's what our goal is, we have to look, These as a unique center of excellence. One, center, it means that you know one center of excellence. So, we have to identify, a variety of ways to help provide, education on the differentiation for a gamma rate for that center that's, pertinent to them. So, hopefully that answers your question, but it varies across ALL40, TOP45 and the TOP100. And then as far as the payers, when we look at the payer, reception for agamry, I mentioned it on the call, over 85%, of the patients are reimbursed, and it's much more than that. So, it's a very strong reception by the pa, and the payer landscape we're very pleased with and we don't anticipate it changing here in the.

當然。問得好。而且，各個卓越中心的情況確實各不相同。杜氏肌肉營養不良症的獨特之處在於，各個卓越中心之間存在著很大的差異。所以，對於患有 DMD 的男孩，醫生並沒有統一的類固醇處方方法。所以，我們有很多這樣的中心，每個中心都有多名患者，例如 10-20 名，有些情況下，患者人數甚至更多。還有一些中心，只有寥寥幾個病人。所以，這就是我們的目標，我們必須把這裡視為一個獨特的卓越中心。一，中心，意味著你了解一個卓越中心。因此，我們必須找到各種方法來幫助提供教育，使之與中心相關的伽馬率差異化。希望這能解答你的疑問，但具體情況在 ALL40、TOP45 和 TOP100 中有所不同。至於付款方，當我們查看付款方時，就 Agamry 而言，我在電話中提到過，超過 85% 的患者獲得了報銷，而且實際報銷比例遠不止這個數字。因此，PA對此反應非常熱烈，我們對支付方的現狀非常滿意，並且預期這種情況不會改變。

So your second question, we just want to clarify was about the year over year strength and then what are the growth drivers that we anticipate that you mentioned new patients, dosing. I think there was third one you mentioned as well.

所以你的第二個問題，我們想澄清一下，是關於同比實力，以及你提到的新患者和劑量等成長驅動因素。我想你也提到了第三個。

The last one was persistence of patients, persistence.

最後一個是患者的堅持，堅持。

Okay.

好的。

Yeah, and then also on the sequential like slowdown implied by the guidance if you can explain that.

是的，還有指南中提到的類似順序減速的問題，如果你能解釋一下就更好了。

Okay.

好的。

Just to make sure we're talking about that's correct. Right. Okay, so, Yeah, and what I want to talk about here is, I did mention this, that the growth from FERS will come from multiple segments, both idiopathic limbs as well as the cancer associated lens. What we're seeing now is, the 500 or so patients that, the pool of patients that we have that are somewhere in their diagnostic journey for lens, we are able to help these patients or convert these patients onto treatment appropriately, Much more quickly and we're doing that by helping focus our field force, our dedicated field force of 16 Rams now on the right, leads to help these patients get on therapy. So, that's one thing. Another thing is, we are, we have many initiatives in place to get BGCC antibody testing added to panels, like, an example is, myasthenia gravis. So, once that's, added, we'll also see a growth in the number of patients that are tested and hopefully diagnosed with LEMS, which we can then focus on and help these patients get on therapy.

為了確保我們說的是正確的。正確的。好的，是的，我想在這裡談談的是，我之前提到過，FERS 的生長將來自多個部分，包括特發性肢體以及與癌症相關的晶狀體。我們現在看到的是，在我們大約 500 名處於晶狀體診斷過程中的患者群體中，我們能夠幫助這些患者或讓他們更快地接受適當的治療，我們正在透過集中我們的現場團隊（我們現在由 16 名 Rams 組成的專門現場團隊，如圖所示）來幫助這些患者接受治療。這是其中一件事。另外，我們已經制定了許多舉措，將 BGCC 抗體檢測添加到檢測項目中，例如重症肌無力。所以，一旦加上這些，我們也會看到接受檢測並有望確診患有 LEMS 的患者人數增加，這樣我們就可以專注於幫助這些患者接受治療。

Another thing is we've identified additional data sources that are providing, more lens, perspective lens patients, to us, which, will then turn into leads that, and increase our pool of patients.

還有一點是，我們已經確定了其他數據來源，這些來源為我們提供更多潛在的鏡片患者，這將轉化為潛在客戶，從而擴大我們的患者群體。

We also utilize machine learning that helps triangulate claims data. So, here's a quick example is we've noticed that patients that have a negative ACHR test as well as a positive EGCC test, those patients are more likely to get on FRA's treatment. And get on treatment sooner. So, then we provide those leads to our team to help those patients, accelerate their time to get on product. So, that's been very beneficial. Couple of other things, the pharmacy intervention program, what we're doing is we noticed that in some cases it takes patients a little longer to titrate than the label to get onto their, optimal, appropriate optimal, dose. And our pharmacy outreach and the intervention program, And, we've seen benefits from that program that have accelerated that time to get on, their appropriate optimal maintenance dose more efficiently. So, a lot of those things are helping contribute to today's growth and we are confident we'll continue to, provide, leverage for us to grow in the future. And then in 2026, we expect CAs to, more, contribute more to the growth

我們也利用機器學習來幫助對理賠資料進行三角驗證。舉個簡單的例子，我們注意到，ACHR 檢測結果為陰性但 EGCC 檢測結果為陽性的患者更有可能接受 FRA 治療。儘早開始治療。然後，我們將這些線索提供給我們的團隊，以幫助這些患者加快獲得產品治療的速度。所以，這非常有益。還有幾件事，關於藥房幹預計劃，我們注意到，在某些情況下，患者需要比標籤上建議的時間更長才能達到最佳、合適的劑量。我們的藥房外展和乾預計劃，以及我們已經看到的計劃帶來的益處，都加快了患者達到適當最佳維持劑量所需的時間，並提高了他們的治療效率。因此，許多因素都有助於我們今天的成長，我們有信心，這些因素將繼續為我們未來的發展提供助力。然後，我們預計到2026年，CAs將對成長做出更大貢獻。

That Pavon, does that address your Question?

帕馮，這回答你的問題了嗎？

Yeah, that addresses the question pretty well, and then I guess just like in terms of like the guidance, why not take it up on for apps at the product level, given the strength thus far, just what's the rationale behind that? Is that just conservatism or is there something that you expect, in 4Q, whether there was a one timer in 3Q or something like that?

是的，這很好地回答了這個問題。然後我想，就指導方針而言，鑑於目前為止的優勢，為什麼不在產品層面上將其應用於應用程式？這樣做的理由是什麼？這僅僅是保守主義嗎？還是說你對第四季有什麼預期，例如第三季是否出現過一次性的銷售業績之類的？

So we know this product really well. For 7 years it's been on the market, so we're confident in our ability to forecast the product.

我們對這款產品非常了解。該產品已上市7年，因此我們對預測該產品的市場表現有信心。

Jeff, do you want to speak at a high level to the performance of new enrollees in the 3rd quarter, just at a high level?

傑夫，你想大致談談第三季新學員的表現嗎？就簡單概括一下就好。

Sure, new enrollees were very strong and much higher than we had forecasted. So it's, it was the highest month that we've had in, two years. Yeah. So.

沒錯，新入學人數非常強勁，遠遠超出我們的預期。所以，這是我們兩年來最高的單月銷售量。是的。所以。

So, but those patients, obviously, we don't get a full year from those patients. So, we're looking forward to that growth continuing as we go into 2026. So, we, we're seeing very positive trends. We like what we see. We like what we see on the testing growth as well. And, there's a touch of, I want to say a touch of seasonality in the 4th quarter. So, We can look at sequentials or we can look at year over year, but we're confident in our continued growth.

所以，很顯然，我們無法從這些患者身上獲得一整年的數據。因此，我們期待這種成長勢頭在2026年繼續保持下去。所以，我們看到了一些非常正面的趨勢。我們很喜歡我們所看到的。我們也對測試業務的成長感到滿意。而且，我想說，第四季還帶有一點季節性因素。所以，我們可以看環比成長，也可以看同比數據，但我們對未來的持續成長充滿信心。

Great, thank you so much. Super helpful. Thank.

太好了，非常感謝。非常有用。感謝。

You.

你。

Luke Herman from Robert W. Berger.

來自羅伯特·W·伯傑的盧克·赫爾曼。

Hi guys, congrats on the quarter and thanks for the question. First, on a gamy, given this week's outcome of confirmatory data from the approved PMOs, which is obviously just really unfortunate for the community, but do you think this can sort of emphasize the importance of an optimal steroid regimen for, physicians and patients and their families?

大家好，恭喜你們本季取得佳績，感謝你們的提問。首先，就本週已獲批准的處方藥機構的確認數據而言，這顯然對整個行業來說非常不幸，但您認為這是否可以強調為醫生、患者及其家人制定最佳類固醇治療方案的重要性？

That's a great question. This is a community that's very tight. They know, they see everything and they're really engaged with us, and obviously all the companies we think about the use of a product like a Gamry.

這是一個很好的問題。這是一個關係非常緊密的社區。他們了解一切，他們目睹一切，並且與我們保持著密切的聯繫，顯然，所有我們認為會使用像 Gamry 這樣的產品的公司也都了解這一點。

It's obviously the first product that a patient gets on. It's recommended. It's foundational therapy, and these news, these stories are unfortunate for the community, but as we gain further and further strength and momentum in the market, we believe that we can fill the necessary gaps that might be coming out about as a result of some of these conversations. Jeff, do you want to speak to what we might have heard so far about some of these issues?

這顯然是患者使用的第一種產品。值得推薦。這是基礎療法，這些新聞、這些故事對社區來說很不幸，但隨著我們在市場上獲得越來越大的力量和勢頭，我們相信我們可以填補因這些討論而可能出現的必要空白。傑夫，你想談談我們目前為止聽到的一些關於這些問題的看法嗎？

Surrounding the studies, yeah.

是的，圍繞著這些研究。

Sure. I mean, I'll stick to the Agamri and steroids, I mean, I think what Rich was, mentioning too is that steroids are the foundation of treatment. Hum.

當然。我的意思是，我會堅持使用阿加姆里和類固醇，我的意思是，我認為里奇也提到過，類固醇是治療的基礎。哼。

For PMD. And so that we know that having that is the biggest part of this and and regardless of what other products that that come out, the steroids will always be the first thing that that that they will treat their patients with.

針對 PMD。因此我們知道，擁有類固醇是其中最重要的部分，無論未來推出什麼其他產品，類固醇始終是他們治療患者的首選藥物。

So yeah, and I think our patient advocacy and then patient support really helps us to kind of weather that those those bumps in the market that don't necessarily affect us directly. And the support that we give to the patients through, Catalyst pathways is really a strong, opportunity for the patients to get past some of these, situations.

是的，我認為我們的患者權益倡議和患者支持確實能幫助我們度過那些不一定直接影響我們的市場波動。我們透過 Catalyst 途徑為患者提供的支持，確實為患者克服其中一些困境提供了強有力的機會。

So, we think we can continue to perform well.

所以，我們認為我們能夠繼續保持良好的表現。

Great. And then I just had one on the financials, and some commentary on payment timing in relation to the cash balance. I think you noted a lower gross to net expense. Is that material, for gross net going forward and was that a benefit in 3Q?

偉大的。然後我做了一個關於財務狀況的報告，並就付款時間與現金餘額的關係發表了一些評論。我想您已經注意到毛支出與淨支出比率有所下降。這是否對未來的毛利淨利產生實質影響？這是否是第三季的收益？

Sure, thanks for the question. It's not insignificant.

當然，謝謝你的提問。這並非微不足道。

So, from a materiality perspective, certainly, we thought it was noteworthy, and then, sorry, what was the second part of that question?

所以，從物質層面來看，我們當然認為這值得注意，然後，抱歉，問題的第二部分是什麼來著？

Was, so is this an impact on a go forward basis or did it affect through you as well?

那麼，這種影響是會持續下去的，還是也透過你受到了影響？

It is in Q3 and impacts the future as well. This is a permanent change to our Our contract terms.

它發生在第三季度，並且會對未來產生影響。這是對我們合約條款的永久性變更。

Right, I just want to emphasize that it's a permanent change we experienced this one timer mostly because if you think about a shift. We renegotiate a very important, very large contract with a buyer, and they used to pay twice a month. Now they only pay once a month, so we received their payment October.

沒錯，我只想強調，這是一個永久性的變化，我們這次經歷的主要是因為如果你想想換班。我們與買方重新協商了一份非常重要、數額巨大的合同，他們以前是每月付款兩次。現在他們每月只支付一次，所以我們在十月收到了他們的付款。

October second we received approximately $24.9 million that under the old terms would have been by September 30th.

10 月 2 日，我們收到了大約 2,490 萬美元，根據舊條款，這筆款項本應在 9 月 30 日之前收到。

So for this issue specifically, because you're asking about. We don't expect this one to repeat. That's right, yeah, so this is a one timer and that's why we called it out in the queue. We wanted to be sure that we were clear about how it might affect Q3, but we expect the customer to continue to pay once a month, and we think that's accommodated for or will be accommodated for on a go forward basis.

所以具體來說，就是你問的這個問題。我們預計這種情況不會再發生。沒錯，是的，這是一次性的，所以我們才在隊列裡把它喊出來。我們希望確保大家清楚這可能會對第三季產生怎樣的影響，但我們預期客戶將繼續每月支付一次，我們認為這一點已經解決，或者將來會得到解決。

All right, thank you.

好的，謝謝。

Thanks.

謝謝。

Thank you.

謝謝。

Sudan Loganson from Stevens Inc.

來自 Stevens 公司的 Sudan Loganson

Hey, good morning, Catalyst team. This is, Key Salvo for Sudan.

嘿，Catalyst團隊，早安。這是對蘇丹的關鍵一擊。

Congrats on the great quarter. My first question is just like, roughly with the 17% off the WAC when Tia came in, what's the expected discount on Phi Kappa after more tablet and suspension generics enter later this year, and how does that discount curve look? And then, my second one is kind of just on bird apps.

恭喜你們本季業績出色。我的第一個問題是，Tia 上市時 WAC 大約有 17% 的折扣，那麼今年晚些時候，隨著更多片劑和懸浮劑仿製藥的上市，Phi Kappa 的預期折扣是多少？折扣曲線是什麼樣的？然後，我的第二個目標就是關於鳥類應用程式的。

With hetero moving to trial slated for March 2026, what was the general sentiment during the Markman hearing considering that TA and Lupin kind of decided to settle?

鑑於異性戀者案的審判定於 2026 年 3 月進行，考慮到 TA 和 Lupin 已經決定和解，Markman 聽證會期間的普遍情緒是什麼？

Thank you.

謝謝。

Thanks. So on the first part of the first question, what we see is a mixed shift as you would expect. So in when a generic enters the market, especially one that's so heavily influenced here by Medicaid, we're not affected in the Medicaid on a volume basis. So we did not, we have not given price, but as we forecasted, we would lose volume. And then there's a mixed shift. So there's By as a percentage, a higher percentage of Medicaid, a lower percentage of commercial, and so that's what causes the price to go down. So the volume changes and it shifts, and then we have an impact on price. So does that answer your question?

謝謝。所以對於第一個問題的第一部分，我們看到的是一種混合變化，正如你所預期的那樣。所以，當仿製藥進入市場時，尤其是像我們這裡受醫療補助計劃影響如此之大的仿製藥，我們在醫療補助計劃方面不會受到銷售上的影響。所以我們沒有給出價格，但正如我們預測的那樣，銷量會下降。然後還有一種混合轉變。所以，從百分比來看，醫療補助的比例較高，商業保險的比例較低，這就是導致價格下降的原因。所以成交量會發生變化，然後就會對價格產生影響。這樣回答了你的問題嗎？

Yeah, it does.

是的，確實如此。

Thank you. Okay, great. Now your second question about hetero and where we stand, I'm going to turn it over to Steve Miller. Steve.

謝謝。好的，太好了。現在，關於異性戀以及我們目前的處境，你的第二個問題，我將交給史蒂夫·米勒來回答。史蒂夫。

Thank you.

謝謝。

With regard to the hearing, it was relatively routine. There was a number of items that were simply pushed off to trial judge who said simply that's a matter for trial.

至於聽證會，過程相對來說比較例行。有很多事項被直接推給了審判法官，而法官只是簡單地說，那是審判的問題。

There was no Dramatic change the view of the enforceability of the patents for either side and the strength of their cases. We continue to remain confident that our intellectual property is strong and we're going to vigorously defend it. I also want to point out that like all the litigants of the past, we continue to have discussions with all of them, including hetero, and if this last litigant has something to say that we think is in the best interest of the shareholders.

雙方對專利可執行性的看法以及各自案件的強弱並沒有發生重大變化。我們依然堅信我們的智慧財產權實力雄厚，並將全力捍衛它。我還想指出，與過去所有訴訟當事人一樣，我們繼續與他們所有人進行討論，包括Hetero，如果這位最後的訴訟當事人有什麼我們認為符合股東最佳利益的意見，我們會予以採納。

Thank you.

謝謝。

Thank you.

謝謝。

Thank you. We've reached the end of our question-and-answer session. I'd like to turn the floor back over for any further closing comments.

謝謝。我們的問答環節到此結束。我想把發言權交還給各位，請大家再做總結發言。

We're really appreciative of the support that we've received from the market, and we're really appreciative of the work that our employees have done in support of patients, and thank you again for your participation in the call today.

我們非常感謝市場給予的支持，也非常感謝我們的員工為支持患者所做的工作，再次感謝您今天參加電話會議。

Thank you. That does conclude today's teleconference and webcast, and we disconnect your line at this time and have a wonderful day. We thank you for your participation today.

謝謝。今天的電話會議和網路直播到此結束，我們現在斷開您的線路，祝您度過美好的一天。感謝您今天的參與。