TG Therapeutics Inc (TGTX) 2025 Q1 法說會逐字稿

Greetings and welcome to TG Therapeutics first quarter conference call and webcast. (Operator Instructions) As a reminder, this conference is being recorded.

問候並歡迎參加 TG Therapeutics 第一季度電話會議和網路廣播。（操作員指示）提醒一下，本次會議正在錄音。

It is now my pleasure to introduce your host Jenna Bosco, Chief Communications Officer. Thank you. You may begin.

現在我很高興向大家介紹主持人、首席通訊官詹娜·博斯科 (Jenna Bosco)。謝謝。你可以開始了。

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the first quarter 2025 financial results are Michael Weiss, our Chairman and Chief Executive Officer; Adam Waldman, our Chief Commercialization Officer; and Sean Power, our Chief Financial Officer.

謝謝。歡迎大家，感謝你們今天早上加入我們。我是詹娜·博斯科 (Jenna Bosco)，今天與我一起討論 2025 年第一季度財務業績的有我們的董事長兼首席執行官邁克爾·韋斯 (Michael Weiss)、我們的首席商業化官亞當·沃爾德曼 (Adam Waldman) 和我們的首席財務官肖恩·鮑爾 (Sean Power)。

Following our Safe Harbor Statement, Mike will provide an overview of our recent corporate developments. Adam will share an update on our commercialization efforts and Sean will give a summary of our financial results before turning the call over to the operator to begin the Q&A session.

在我們的安全港聲明之後，麥克將概述我們最近的公司發展。Adam 將分享我們商業化努力的最新進展，Sean 將總結我們的財務業績，然後將電話轉給接線員開始問答環節。

Before we begin, I'd like to remind everyone that we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected milestones, revenue guidance, development plans and expectations for our marketed products.

在我們開始之前，我想提醒大家，我們將根據 1995 年《私人證券訴訟改革法案》的規定做出前瞻性陳述。這些前瞻性陳述包括我們預期的未來營運和財務表現的陳述，包括銷售業績、預期的里程碑、收入指導、發展計劃和對我們行銷產品的期望。

TG cautions that these forward-looking statements are subject to risks that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics' operations include various risk factors that can be found in our SEC filings.

TG 警告稱，這些前瞻性陳述存在風險，可能導致我們的實際結果與所述的結果有重大差異。可能影響 TG Therapeutics 營運的因素包括可以在我們的 SEC 文件中找到的各種風險因素。

In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any later date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for rebroadcast on TG's website at www.tgtherapeutics.com, where it will be available for the next 30 days.

此外，本次電話會議中所做的任何前瞻性陳述僅代表我們截至今天的觀點，不應被視為代表我們在任何以後日期的觀點。我們明確否認有更新或修改任何前瞻性陳述的義務。此次電話會議將被錄製並在 TG 的網站 www.tgtherapeutics.com 上重播，並將在接下來的 30 天內在該網站上提供。

Now I'd like to turn the call over to Mike Weiss, our CEO.

現在我想將電話轉給我們的執行長麥克·韋斯。

Thanks, Jenna, and good morning, everybody, and thanks for joining us on today's call. It's a pleasure to be here with you and to provide an update on TG's continued progress, both in the successful launch of BRIUMVI and in building a company committed to improving the lives of those living with multiple sclerosis.

謝謝，珍娜，大家早安，謝謝你們參加今天的電話會議。我很高興能和大家在一起，並向大家介紹 TG 在成功推出 BRIUMVI 和建立一家致力於改善多發性硬化症患者生活的公司方面取得的持續進展。

I'm excited to share that we kicked off 2025 with another strong quarter of performance, underscoring the sustained momentum behind BRIUMVI. As you may have seen in the press release this morning, BRIUMVI US net sales reached nearly $120 million in the first quarter, once again exceeding our expectations.

我很高興地告訴大家，我們在 2025 年迎來了又一個強勁的季度業績，這凸顯了 BRIUMVI 持續的發展勢頭。正如您可能在今天早上的新聞稿中看到的那樣，BRIUMVI 美國淨銷售額在第一季達到近 1.2 億美元，再次超出了我們的預期。

This growth reflects both the increasing adoption by health care providers and a rising tide of patient interest and confidence in BRIUMVI. Over the past month, I spent a significant amount of time in the field, meeting with prescribers and it's energizing to see firsthand of BRIUMVI's becoming the go-to anti-CD20 therapy for many of them.

這種增長既反映了醫療保健提供者的日益普及，也反映了患者對 BRIUMVI 的興趣和信心不斷增長。在過去的一個月裡，我花了大量時間在現場，與處方醫生會面，親眼看到 BRIUMVI 成為許多醫生的首選抗 CD20 療法，我感到非常振奮。

But what's even more gratifying is hearing directly from people living with MS. At a recent MS walk, I spoke with two individuals who shared their experiences switching to BRIUMVI from another approved IV anti-CD20 therapy. They both described how they previously felt unwell for days or more after each infusion but not with BRIUMVI.

但更令人欣慰的是直接聽到多發性硬化症患者的聲音。在最近的 MS 步行活動中，我與兩位患者進行了交談，他們分享了從另一種獲批的 IV 抗 CD20 療法轉換到 BRIUMVI 的經歷。他們都描述了以前每次輸液後都會感到不適幾天或更長時間，但使用 BRIUMVI 後不會出現這種情況。

Their stories echo findings from a recent paper in Frontiers in Immunology which highlighted seven case reports of people with MS who switched to BRIUMVI from a prior anti-CD20 due to issues like tolerability, disease activity, wearing off effects or incomplete B-cell depletion.

他們的故事與《免疫學前沿》最近一篇論文的研究結果相呼應，該論文重點介紹了 7 例 MS 患者病例報告，他們由於耐受性、疾病活動性、療效減退或 B 細胞耗竭不完全等問題，從之前的抗 CD20 轉而使用 BRIUMVI。

In each case, the unwanted effect either resolved or did not recur with BRIUMVI. These real-world experiences support the idea that not all CD20s are the same, and that switching within the class may make a difference.

在每種情況下，不良反應都會透過 BRIUMVI 解決或不再復發。這些現實世界的經驗支持了這樣的觀點：並非所有 CD20 都是相同的，並且在類別內切換可能會有所不同。

This point is reinforced by another recent publication in CNS drugs, which explores how structural and mechanistic differences among CD20 therapies may drive variations in efficacy and tolerability. Word of mouth within the MS community is powerful, and we believe these success stories are helping to drive continued growth and enthusiasm.

《中樞神經系統藥物》雜誌上的另一篇近期出版物也強化了這一觀點，該出版物探討了 CD20 療法之間的結構和機制差異如何導致療效和耐受性的變化。多發性硬化症 (MS) 社群內的口碑具有強大的力量，我們相信這些成功故事有助於推動持續的成長和熱情。

As I often say, more people who start BRIUMVI, the more people will start BRIUMVI. And even in a highly competitive market, our team and BRIUMVI's unique profile are rising to the challenge, I couldn't be more proud of how our team has executed our multiphase launch strategy and the strong start we've made in 2025 as we pursue our long-term goal of making BRIUMVI the number one prescribed anti-CD20 as measured by dynamic market share.

正如我常說的，啟動 BRIUMVI 的人越多，啟動 BRIUMVI 的人就越多。即使在競爭激烈的市場中，我們的團隊和 BRIUMVI 的獨特形像也在迎接挑戰，我對我們的團隊如何執行多階段發布策略以及我們在 2025 年取得的強勁開局感到無比自豪，因為我們追求我們的長期目標，即讓 BRIUMVI 成為以動態市場份額衡量的頭號處方抗 CD20 藥物。

In a moment, Adam Waldman, our Chief Commercialization Officer, will walk you through the commercial performance in more detail. As well as our investment priorities and updated guidance for Q2 and full year 2025. But first, I'd like to highlight our pipeline and efforts to enhance the BRIUMVI experience.

稍後，我們的首席商業化長 Adam Waldman 將向您更詳細地介紹商業表現。以及我們對 2025 年第二季和全年的投資重點和最新指導。但首先，我想強調我們的管道和為增強 BRIUMVI 體驗所做的努力。

Our core focus of our innovation strategy is simplifying the patient experience. Our enhanced clinical trial is designed to help us evaluate a number of these strategies and has already yielded some encouraging results.

我們的創新策略的核心重點是簡化患者體驗。我們的強化臨床試驗旨在幫助我們評估其中一些策略，並且已經取得了一些令人鼓舞的結果。

We previously presented the data from this study, demonstrating the safety and tolerability of a 30-minute maintenance infusion as well as initiating BRIUMVI treatment with a single full dose 450-milligram fusion for patients switching from another CD20 who had low B-cell counts.

我們之前曾展示過這項研究的數據，證明了 30 分鐘維持輸注的安全性和耐受性，以及對於從另一種 CD20 轉換且 B 細胞計數低的患者，以單次全劑量 450 毫克融合啟動 BRIUMVI 治療。

And most recently at AAN last month, we shared new data showing the safety and tolerability of starting all patients on BRIUMVI with a single 600-milligram dose on day one effectively eliminating the need for a day 15 dose. Feedback on this streamlined approach has been very positive.

最近，我們在上個月的 AAN 上分享了新數據，顯示了所有患者在第一天開始服用 BRIUMVI 的安全性和耐受性，即單次 600 毫克劑量，從而有效地消除了第 15 天服用劑量的需要。對這種簡化方法的回饋非常積極。

We believe patients will appreciate the simplicity of starting treatment with just one infusion visit, making BRIUMVI a true twice-a-year therapy from day one. We are now preparing to advance this regimen into its registration directed trial.

我們相信患者會喜歡只需一次輸液即可開始治療的簡單性，這使得 BRIUMVI 從第一天起就成為真正的一年兩次的治療方法。我們現在正準備推進該方案的註冊指導試驗。

Another exciting initiative is the development of a self-administered subcu BRIUMVI. While the vast majority of patients continue to prefer to receive their anti-CD20 as an IV infusion, there is a growing minority we're now choosing a self-administered subcutaneous option of which there is only one available today. We see a clear opportunity to expand access and choice with a self-administered subcu BRIUMVI.

另一個令人興奮的舉措是開發自我管理的皮下注射 BRIUMVI。儘管絕大多數患者仍傾向於透過靜脈輸注接受抗 CD20 治療，但越來越多的少數患者現在選擇自行注射皮下注射，而目前只有一種可供選擇的方案。我們看到了透過自我管理的皮下注射 BRIUMVI 來擴大訪問和選擇的明顯機會。

Our ongoing Phase 1 safety and bioclobin study is showing promising results. The subcu injection appears to be well tolerated with bioavailability that appears to support every other month or even potentially quarterly dosing. We're pleased with the progress so far and are on track to launch a pivotal trial this year.

我們正在進行的第一階段安全性和 bioclobin 研究顯示出了令人鼓舞的結果。皮下注射似乎具有良好的耐受性，其生物利​​用度似乎支持每隔一個月甚至每季給藥。我們對目前的進展感到滿意，並有望在今年啟動一項關鍵試驗。

We also believe the subcu formulation may open new doors for us in new indications. One area that we are currently exploring is the potential for subcu BRIUMVI and myasthenia gravis, and we're evaluating potential additional indications as well.

我們也相信皮下製劑可能為我們在新適應症領域打開新的大門。我們目前正在探索的一個領域是皮下 BRIUMVI 和重症肌無力的潛力，我們也在評估潛在的其他適應症。

Finally, on the pipeline front, we continue to be excited about azer-cel, our allogeneic CD19 CAR-T cell therapy. It's early days for CAR-Ts and autoimmune diseases, but we see great potential across multiple indications. We are excited to launch our Phase 1 for azer-cel in progressive forms of MS a segment of the MS population with limited treatment options and poor prognosis.

最後，在管道方面，我們繼續對我們的同種異體 CD19 CAR-T 細胞療法 azer-cel 感到興奮。CAR-T 和自體免疫疾病還處於早期階段，但我們看到了多種適應症的巨大潛力。我們很高興啟動 azer-cel 針對進展型 MS 的 1 期臨床試驗，該類型 MS 患者是治療選擇有限且預後不良的群體。

In closing, 2025 is off to a very strong start. We're executing on our commercial strategy, advancing our clinical programs after expanding our manufacturing capacity to meet the growing demand. I want to thank the entire TG team for their dedication and hard work is our commitment to our mission that enables us to deliver meaningful progress for individuals with relapsing forms of MS.

總而言之，2025 年開局非常強勁。我們正在執行我們的商業策略，在擴大我們的生產能力以滿足不斷增長的需求之後推進我們的臨床專案。我要感謝整個 TG 團隊的奉獻和辛勤工作，這是我們對使命的承諾，使我們能夠為復發型 MS 患者帶來有意義的進展。

And now I'll turn the call over to Adam Waldman, our Chief Commercialization Officer. Adam, go ahead.

現在我將把電話轉給我們的首席商業化官亞當·沃爾德曼 (Adam Waldman)。亞當，繼續吧。

Thanks, Mike, and good morning, everyone. I'm excited to share the details of another strong quarter of commercial execution, delivering meaningful growth and further validating our belief in the long-term potential of BRIUMVI in the RMS market.

謝謝，麥克，大家早安。我很高興與大家分享另一個強勁的商業執行季度的細節，實現了有意義的成長，並進一步驗證了我們對 BRIUMVI 在 RMS 市場長期潛力的信心。

US net sales for BRIUMVI in the first quarter of 2025 were approximately $119.7 million, exceeding our internal expectations and reflecting a strong start to the year with 137% year over year growth and 16% sequential quarter over quarter growth. Based on this performance and the strength of leading indicators, we are increasing our full year 2025 BRIUMVI US net revenue guidance, which I will detail at the end of my remarks.

2025 年第一季度，BRIUMVI 在美國的淨銷售額約為 1.197 億美元，超出了我們的內部預期，並反映了今年強勁的開局，同比增長 137%，環比增長 16%。基於這項表現和領先指標的強勁表現，我們將上調 2025 年全年 BRIUMVI 美國淨收入預期，我將在發言結束時詳細說明。

We continue to see strength across our key performance drivers. The first three months of the year marked our highest months of total new patient enrollments since launch, a clear indication that demand continues to accelerate. This is despite the headwinds typically seen in the first quarter and an ongoing competitive product launch. Importantly, March was also our highest month ever for repeat prescribers with physicians coming back to prescribe BRIUMVI again, a strong signal of growing prescriber confidence and satisfaction.

我們持續看到關鍵績效驅動因素的強勁表現。今年前三個月是我們自成立以來新增患者總數最高的月份，這清楚地表明需求持續加速成長。儘管第一季通常會出現逆風，並且競爭性產品不斷推出，但情況仍然如此。重要的是，三月也是我們重複開藥人數最多的一個月，醫生們再次開出 BRIUMVI，這強烈表明開藥者的信心和滿意度不斷增強。

Further, we saw continued strength in the hospital setting, which contributed approximately 60% of enrollments in March, the highest percent to date, highlighting our deepening footprint among institutional accounts.

此外，我們看到醫院環境持續保持強勁勢頭，3 月份醫院環境的入院人數約佔總入院人數的 60%，為迄今為止的最高比例，凸顯了我們在機構帳戶中日益加深的影響力。

With discontinued growth for the first time repeat prescriptions have now surpassed new prescriptions, a key inflection point in BRIUMVI's life cycle demonstrating strong persistence trends at week 24 and week 48. While we remain in a competitive marketplace, BRIUMVI continues to stand out. Our five year data, consistent real-world safety and efficacy profile combined with our unique one hour twice-a-year infusion, remain highly compelling to both physicians and patients.

隨著首次停止成長，重複處方現已超過新處方，這是 BRIUMVI 生命週期的關鍵轉折點，在第 24 週和第 48 週表現出強勁的持久趨勢。儘管我們仍處於競爭激烈的市場中，但 BRIUMVI 仍然脫穎而出。我們的五年數據、一致的真實世界安全性和有效性概況，加上我們獨特的每年兩次、每次一小時的輸液，對醫生和患者來說仍然具有很強的吸引力。

Importantly, we are seeing both an expansion of the CD20 market overall and continued dynamic market share gains for BRIUMVI and the anti-CD20 IV segment, driven by both newly diagnosed patient starts and an increasing volume of switch patients.

重要的是，我們看到 CD20 市場整體擴張，BRIUMVI 和抗 CD20 IV 領域的市場份額持續動態增長，這得益於新診斷患者的開始和轉換患者數量的增加。

Additionally, from my point of view, the field team has executed with excellence. We've deepened our reach among high-volume infusion centers, community neurologists and leading academic institutions, and we continue to receive positive feedback on our team from our customers.

此外，從我的角度來看，現場團隊的表現非常出色。我們已加深與高容量輸液中心、社區神經病學專家和領先學術機構的聯繫，並且我們團隊不斷收到客戶的正面回饋。

As we look ahead to the remainder of 2025, we are focused on several key growth drivers. First, continuing to accelerate uptake among community neurologists, academic and broader practice types. Second, we will be launching our first ever direct-to-patient BRIUMVI television commercial campaign, including full digital surround sound strategy, to educate, inspire and activate eligible patients to seek out BRIUMVI treatment. Third, our teams will continue to build and leverage a real-world evidence to support BRIUMVI's position as a differentiated and trusted anti-CD20 option.

展望 2025 年剩餘時間，我們將重點放在幾個關鍵的成長動力。首先，繼續加速社區神經病學家、學術界和更廣泛的實踐類型的吸收。其次，我們將推出首個直接面向患者的 BRIUMVI 電視商業廣告活動，包括全數位環繞聲策略，以教育、啟發和鼓勵符合條件的患者尋求 BRIUMVI 治療。第三，我們的團隊將繼續建立和利用真實世界的證據來支持 BRIUMVI 作為差異化和值得信賴的抗 CD20 選項的地位。

And fourth, we will start preparing for life cycle innovations, including our subcutaneous formulation, which we believe represents a significant long-term growth opportunity. In summary, we are off to a strong start in 2025.

第四，我們將開始為生命週期創新做準備，包括我們的皮下製劑，我們相信這代表著一個重要的長期成長機會。總而言之，我們在 2025 年取得了良好的開端。

Our Q1 results reflect growing demand, increasing prescriber confidence, growing patient awareness and broad commercial execution. Looking ahead, we are optimistic about the continued growth and potential of BRIUMVI. As I mentioned, based on current trends in both new patient accumulations and persistence, we are raising our full year 2025 US net revenue guidance for $525 million, which we highlighted at JPMorgan in January to $560 million for the full year 2025.

我們的第一季業績反映出需求不斷增長、處方醫生信心不斷增強、患者意識不斷增強以及商業執行範圍不斷擴大。展望未來，我們對 BRIUMVI 的持續成長和潛力持樂觀態度。正如我所提到的，基於目前新病患累積和持續性的趨勢，我們將 2025 年全年美國淨收入預期上調至 5.25 億美元，我們在 1 月份在摩根大通強調的這一目標為 2025 年全年 5.6 億美元。

Additionally, Q2 was already off to a strong start with April being another record month for enrollments into our hub. And while we are still early into the quarter, we're currently targeting $135 million for the second quarter.

此外，第二季已經取得了強勁的開局，四月成為我們中心註冊人數創下新高的月份。雖然本季仍處於初期階段，但我們目前的目標是第二季實現 1.35 億美元的銷售額。

With a robust foundation in place, multiple catalysts on the horizon and a highly differentiated product, we believe BRIUMVI is well positioned to become a market-leading therapy in RMS. I want to thank our commercial team for their tireless commitment to drive. Your work is making a meaningful impact on the lives of people living with MS. We're proud of the momentum we've built, and I'm more excited than ever about what lies ahead.

憑藉著堅實的基礎、即將出現的多種催化劑和高度差異化的產品，我們相信 BRIUMVI 有能力成為 RMS 領域的市場領先療法。我要感謝我們的商業團隊不懈的努力。您的工作對多發性硬化症患者的生活產生了重大影響。我們為已經取得的進展感到自豪，並且對未來感到比以往任何時候都更加興奮。

And with that, I'll turn the call over to Sean to walk through our financials. Sean?

說完這些，我會把電話轉給肖恩，讓他介紹我們的財務狀況。肖恩？

Thank you, Adam, and good morning, everyone. Earlier this morning, we reported our detailed first quarter 2025 financial results in a press release, which is available on the investors and media section of our website.

謝謝你，亞當，大家早安。今天早些時候，我們在新聞稿中報告了我們 2025 年第一季的詳細財務業績，該新聞稿可在我們網站的投資者和媒體部分查閱。

I'd like to start today with a quick overview of our first quarter revenue, something Adam and Mike both already touched on briefly. We're very pleased to report US net product revenue of $119.7 million for the first quarter of 2025.

今天，我想先簡單介紹一下我們第一季的收入，亞當和麥克都已經簡單地談到了這一點。我們非常高興地報告，2025 年第一季美國淨產品收入為 1.197 億美元。

This reflects 137% growth compared to the same period last year and a 16% increase over the fourth quarter of 2024. This continued momentum underscores the strong demand that we're seeing for BRIUMVI.

與去年同期相比成長了 137%，與 2024 年第四季相比成長了 16%。這種持續的勢頭凸顯了我們對 BRIUMVI 的強勁需求。

Turning to operating expenses. Excluding noncash items, our total OpEx for the quarter, which includes both R&D and SG&A expenses came in at approximately $82 million for the quarter. That's tracking slightly ahead of our full year guidance of approximately $300 million. This increase during the quarter was primarily driven by about $20 million in manufacturing investments for subcutaneous BRIUMVI.

談到營運費用。不包括非現金項目，本季我們的總營運支出（包括研發和銷售、一般及行政費用）約為 8,200 萬美元。這略高於我們全年約 3 億美元的預期。本季的成長主要得益於對皮下 BRIUMVI 約 2,000 萬美元的製造投資。

We expect these costs charged to R&D to fluctuate from quarter to quarter. But importantly, we remain confident in our full year OpEx guidance of approximately $300 million. On the bottom line, thanks to the continued strong performance of BRIUMVI, we reported GAAP net income of approximately $5 million or $0.03 per diluted share for the quarter ended March 31, 2025.

我們預計這些研發成本每季都會有所波動。但重要的是，我們仍然對全年約 3 億美元的營運支出指引充滿信心。總而言之，由於 BRIUMVI 持續強勁的表現，我們報告稱，截至 2025 年 3 月 31 日的季度，GAAP 淨收入約為 500 萬美元或每股攤薄收益 0.03 美元。

And finally, a quick note on our balance sheet. We closed the quarter with $276 million in cash, cash equivalents and investment securities. We believe this puts us in a strong financial position to continue executing our commercial strategy, advancing our pipeline and supporting our operations for the foreseeable future.

最後，簡單介紹一下我們的資產負債表。本季結束時，我們擁有 2.76 億美元的現金、現金等價物和投資證券。我們相信，這將使我們擁有強大的財務狀況，能夠在可預見的未來繼續執行我們的商業策略、推進我們的產品線並支持我們的營運。

Before concluding, I'd like to offer some initial perspectives on the recent discussions regarding potential tariffs. As you may know, BRIUMVI is currently manufactured in South Korea. Given our relatively low cost of goods, we do not anticipate that the currently proposed tariffs will have a material impact on our gross margins or overall financial performance. Nonetheless, we are actively monitoring developments and evaluating all of our options.

在結束之前，我想就最近有關潛在關稅的討論發表一些初步看法。您可能知道，BRIUMVI 目前在韓國製造。鑑於我們的商品成本相對較低，我們預計目前提出的關稅不會對我們的毛利率或整體財務表現產生重大影響。儘管如此，我們正在積極監測事態發展並評估我們所有的選擇。

With that, I will now turn the call over to the conference operator to begin the Q&A.

現在，我將把電話轉給會議接線員，開始問答環節。

(Operator Instructions)

（操作員指示）

Tara Bancroft, TD Cowen.

塔拉·班克羅夫特（Tara Bancroft），TD Cowen。

Hi, good morning, and thanks for taking the question. So I was hoping maybe you could provide a little bit more color on competitive dynamics, especially with Ocrevus de novo? And like what are you seeing with new patient share there. I asked because Roche had a small but meaningful miss this quarter. So I'm wondering what you're hearing, if anything, on preferred uptake of BRIUMVI in new patients versus other treatments. Thanks so much.

大家好，早安，謝謝您回答這個問題。所以我希望您能提供更多關於競爭動態的信息，特別是關於 Ocrevus de novo？您在那裡看到新病人分享的情況如何？我之所以問這個問題，是因為羅氏公司本季出現了一個小但意義重大的失誤。因此，我想知道您是否聽說了有關新患者優先採用 BRIUMVI 而非其他治療方法的資訊。非常感謝。

Adam, do you want to go ahead and take that one?

亞當，你想繼續拿那個嗎？

Yeah, sure. I think, as I mentioned in my comments, Tara, that we saw the highest three months ever on patient enrollments. We saw a really strong month in April. So we believe we'll continue to drive market share gains. We sat back at JPMorgan, we think we're getting about 25% of the IV segment.

是的，當然。塔拉，正如我在評論中提到的那樣，我認為我們經歷了患者入院人數最高的三個月。四月份確實表現強勁。因此我們相信我們將繼續推動市場份額的成長。我們回顧摩根大通，我們認為我們將獲得 IV 細分市場的 25% 左右。

We assume that's up from there, and we continue to see good traction in the marketplace. So we're really encouraged by what we're seeing. On the question on de novo, but what we can tell, we've seen zero impact on BRIUMVI.

我們假設從那時起，市場就會繼續呈現良好勢頭。我們對所看到的情況感到非常鼓舞。關於從頭開始的問題，但我們可以說，我們沒有看到對 BRIUMVI 的任何影響。

Great. Thank you so much.

偉大的。太感謝了。

Thank you.

謝謝。

Michael DiFiore, Evercore ISI.

Michael DiFiore，Evercore ISI。

Hey guys, hope all is well. Thanks for taking my question. Just two for me. Just any update on gross to net trends this quarter, a figure in how the Part D redesign that may have affected this. And any comments on how this may affect gross net for the balance of the year.

嘿夥計們，希望一切都好。感謝您回答我的問題。對我來說只要兩個。只是本季總額與淨額趨勢的任何更新，以及 D 部分重新設計可能對此產生的影響的數字。以及關於這將如何影響今年餘額的總淨額的任何評論。

And also with regards to gross margin, when can we expect you to fully deplete, I guess, the prelaunch reserves in gross margin? And perhaps when could we expect maybe kind of a decrease there. Thank you.

另外關於毛利率，我猜我們什麼時候可以預期你們的毛利率會完全耗盡？也許什麼時候我們才能預期到那裡會出現某種程度的下降。謝謝。

Adam, let's take the GTM and maybe, Sean, on the gross margin?

亞當，我們來看看 GTM，肖恩，也許可以看一下毛利率？

Sure. On the gross to net question, no material change in gross to net in the quarter. Part D redesign is not really relevant for our drug, which we look like Part B drugs. Sean?

當然。關於總額與淨額的問題，本季總額與淨額沒有實質變動。D 部分的重新設計與我們的藥物並不真正相關，它看起來像 B 部分藥物。肖恩？

Yeah, sure. Thanks, Mike. So we fully depleted that pretty that pre-commercial inventory reserve that you're seeking at. So the margins you're seeing this quarter and going forward to be the fully big number and consistent quarter to quarter.

是的，當然。謝謝，麥克。因此，我們完全耗盡了您所尋求的相當多的商業前庫存儲備。因此，您看到本季及未來的利潤率將是一個相當大的數字，並且每個季度都保持一致。

Thanks.

謝謝。

Thanks, Michael.

謝謝，麥可。

Roger Song, Jefferies.

傑富瑞 (Jefferies) 的羅傑宋 (Roger Song)。

Great. Congrats for the quarter and then thank you for taking our questions. So maybe the question related to the subcu of BRIUMVI, you said you will start pivotal this year. So just curious what is current thinking about how many doses you will move forward and then when we will start to see the PK data second half. Thank you.

偉大的。恭喜本季取得的成績，並感謝您回答我們的問題。所以也許這個問題與 BRIUMVI 的 subcu 有關，您說您將在今年開始關鍵的行動。所以我很好奇您目前考慮的是要推進多少劑量，然後我們什麼時候才能開始看到 PK 數據的後半部分。謝謝。

Sure. Thanks, Roger. Yeah, I mean we're still leaning toward having two dosing regimens in there. So the every other month and the quarterly as part of the pivotal. Obviously got a little time to make a final decision, but that's definitely where we're leaning today.

當然。謝謝，羅傑。是的，我的意思是我們仍然傾向於採用兩種給藥方案。因此，每隔一個月和每季都是關鍵的一部分。顯然還需要一點時間來做出最終決定，但這絕對是我們今天的傾向。

And in terms of PK data coming out probably later this year, you just haven't been focused and we continue to collect more data. So I think we're continuing to work on that study. It's going to lead us right into the trial, and then we'll figure out when we present some of the data. But again, I think we're being super conservative in having to dosing regimens in the pivotal trial, if we do that. And if we don't do that, it's because we're so confident in one or the other.

就今年稍後發布的 PK 數據可能而言，您還沒有集中註意力，我們會繼續收集更多數據。所以我認為我們會繼續進行這項研究。它將直接引導我們進入試驗階段，然後我們會弄清楚何時提供一些數據。但是，我認為如果我們這樣做的話，我們在關鍵試驗中對給藥方案的採用就過於保守了。如果我們不這樣做，那是因為我們對其中一個太有信心了。

Thank you.

謝謝。

Thanks, Roger.

謝謝，羅傑。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley 證券。

Yes, good morning. Thanks for taking our questions and congrats on the quarter. On the 30-minute infusion data that also we saw at AAN an update, Mike, could you touch on the physician feedback there? And also, how might your data be tracking in depleting -- depleted and non-depleted patients as you obviously try to understand the switch profile in ENHANCE broadly about your Phase 3 trial, scale and scope. If you could comment on that, that would be helpful.

是的，早安。感謝您回答我們的問題，並祝賀本季取得的成績。關於我們在 AAN 更新中看到的 30 分鐘輸液數據，Mike，您能談談那裡的醫生回饋嗎？而且，當您顯然試圖廣泛了解 ENHANCE 中有關您的 3 期試驗、規模和範圍的切換概況時，您的數據如何在藥物耗盡和未耗盡的患者中進行追蹤。如果您能對此發表評論，那將會很有幫助。

Sure. So with respect to the 30-minute infusion, the feedback has been positive. Actually, maybe, Adam, you've talked to a lot of folks about that as well. Maybe you want to touch on the 30-minute infusion, any thoughts there?

當然。因此，對於 30 分鐘的輸液，回饋是正面的。事實上，亞當，也許你也和很多人談論過這個問題。也許您想談談 30 分鐘的輸液，有什麼想法嗎？

Yeah. I think there's been very positive feedback on the 30-minute infusion. Physicians think it's a convenience for their busy infusion centers. Patients think it's a much more convenient option. And the data so far is showing that it's well tolerated. So it's been a very positive and physicians have encouraged us to continue to develop.

是的。我認為 30 分鐘輸液得到了非常正面的回饋。醫生們認為這為他們繁忙的輸液中心帶來了便利。患者認為這是一個更方便的選擇。到目前為止的數據表明它具有良好的耐受性。所以這是一個非常積極的進展，醫生鼓勵我們繼續發展。

Thanks, Adam. Yeah. So -- sorry, did I cut you off, Mayank?

謝謝，亞當。是的。那麼——抱歉，我打斷你了嗎，Mayank？

No, no, go ahead. You were going to comment on Phase 3. And my question, the second part was actually around the R&D spend also, which seems like it's tracking higher yes, if you could factor in the Phase 3 comments there that would stand this year, for example? And then also, as you thought kind of commented on the SG&A spend, for second half, given the DTC spend commitment if you could comment on how you're thinking about profitability going forward?

不不不，繼續吧。您原本要對第三階段發表評論。我的問題是，第二部分實際上也與研發支出有關，似乎支出正在走高，是的，如果您能將今年的第三階段評論考慮在內，那會怎麼樣？然後，正如您所想的那樣，對於下半年的銷售、一般和行政費用 (SG&A) 支出，考慮到 DTC 支出承諾，您是否可以評論一下您對未來盈利能力的看法？

Yeah, Mayank, you've got a lot in there. So I'll try to take it in a few steps, and you can follow up if you like. But the -- just in terms of the pivotal program, so I'll just be clear, there's two pivotal programs that we're planning.

是的，Mayank，你有很多東西。因此，我將嘗試分幾個步驟進行，如果您願意，可以跟進。但是 — — 就關鍵項目而言，我要明確一點，我們正在計劃兩個關鍵項目。

One is for the combined day 1 and day 15 dose, that study again should simplify the onboarding of patients. So we're looking at the 600-milligram dose on day 1 and day 15, and that study should start hopefully in the next one, two, three months a little late.

一項是針對第 1 天和第 15 天的合併劑量，研究應再次簡化患者的入院治療。因此，我們正在研究第 1 天和第 15 天的 600 毫克劑量，研究預計將在未來一、二、三個月內開始，儘管稍晚。

So that's ongoing 30-minute infusion is probably something we're going to look at getting going later in the year or early next year. There's a little more logistics involved in that program than the 600 milligram.

因此，我們可能會考慮在今年稍後或明年年初開始進行持續的 30 分鐘輸液。該計劃涉及的後勤工作比 600 毫克稍微多一些。

In terms of the R&D spend that Sean mentioned, again, I think the only delta is just the materials that we have to produce to make the subcu that hit the R&D line instead of the CMC manufacturing line. So I think in terms of our overall R&D spend, we're right on target to what we thought would be.

關於 Sean 提到的研發支出，我認為唯一的差異就是我們必須生產的材料，以製造進入研發線而不是 CMC 生產線的子模組。因此，我認為就我們的整體研發支出而言，我們完全達到了預期的目標。

And in terms of profitability, I'll let Sean discuss two or three things you can add. But I don't think we're highly focused on profitability this year. And I think in terms of the way we view the world, we're not using cash, we should be driving cash through the business.

在盈利能力方面，我會讓肖恩討論您可以添加的兩三件事。但我認為我們今年並不會高度關注獲利能力。我認為，從我們看待世界的角度來說，我們不使用現金，而應該透過業務來推動現金。

But I don't think we're prepared to start targeting profitability and earnings per share on an ongoing basis. I think we'll stick to revenue guidance for now and some OpEx guidance that we do have plans to not use cash during the course of the year, that's for sure. Is there something else I missed in there, Mayank, you had a few points.

但我認為我們還沒有準備好開始持續追求獲利能力和每股盈餘。我認為我們現在會堅持收入指導和一些營運支出指導，我們確實計劃在今年不使用現金，這是肯定的。我是否還遺漏了什麼，Mayank，您提到了幾點。

You discovered it all. Thank you, Mike. And lastly, on -- I have to ask a traffic question. How far along is your North Carolina plant in being able to produce commercial scale manufacturing, if you could just update on that. And thanks for taking my questions.

你發現了一切。謝謝你，麥克。最後，我想問一個有關交通的問題。您能否更新一下您的北卡羅來納州工廠在商業規模生產方面進展如何？感謝您回答我的問題。

Yeah, you got it. Yeah. So moving manufacturing is not an easy task. And so I think we've said only several years before we'd be able to manufacture out of that North Carolina facility. So for the moment, I don't think it's a near-term event. It will take several years, I know the group is he's working processes to get there, including potentially even starting out in Europe to perfect it while they're actually working on the facility here.

是的，你明白了。是的。因此，轉移製造業並不是一件容易的事。所以我認為我們說過只需幾年時間我們就能在北卡羅來納州的工廠進行生產。因此就目前而言，我認為這不會是短期事件。這將需要幾年的時間，我知道他的團隊正在努力實現這一目標，包括甚至可能從歐洲開始完善它，同時他們實際上正在這裡的設施上工作。

So it's a long-term process. It was never really meant that all occurred as everyone may remember before any of this tariff talk. It was not a design program for avoiding tariffs. Or is it a design program to have backup manufacturing. So we're working on it as quickly as we can. But again, as Sean mentioned, I don't think we feel that we're going to be impacted too much from any of the tariff stuff. I don't know what the final outcome is.

所以這是一個長期的過程。正如大家可能記得的，在這次關稅談判之前，這一切都不是真的發生了。這不是一個為避免關稅而設計的計劃。或者它是一個具有備用製造的設計程序。因此我們正在盡快開展工作。但正如肖恩所提到的那樣，我認為我們不會受到任何關稅的太大影響。我不知道最終結果是什麼。

Understood. Thank you, Mike.

明白了。謝謝你，麥克。

Eric Joseph, JP Morgan.

艾瑞克‧約瑟夫，摩根大通。

Hi guys. This is Ron on for Eric. Congrats on the quarter. And just wanted to ask, I believe you previously cited expectations with about 20% product adherence between biannual infusions. Do you have a sense of that matter in Q1 and any anticipated fluctuations going forward? Thanks.

嗨，大家好。這是羅恩 (Ron) 代替埃里克 (Eric) 上場。恭喜本季取得佳績。我只是想問一下，我相信您之前提到過，每半年輸液一次，產品依從率大約是 20%。您對第一季的情況以及未來預計會出現的波動有什麼看法？謝謝。

Sure. Adam, you want to grab that one?

當然。亞當，你想抓住那個嗎？

Yeah, sure. Can you just clarify the question? I didn't care the first you said -- did you -- what was the percentage you said?

是的，當然。你能澄清一下這個問題嗎？我不在乎你先說了什麼——你說過——你說的百分比是多少？

70% adherence between biannual infusions.

每兩年輸註一次的依從率為 70%。

Yeah. I don't remember saying that. But what I would say is the persistence trends, as I said in my remarks, remain very much very positive and persistence remains strong and above our expectations.

是的。我不記得我說過那句話。但我想說的是，正如我在發言中所說，持久性趨勢仍然非常積極，持久性仍然強勁，超出了我們的預期。

Thank you, guys.

謝謝你們。

Prakhar Agrawal, Cantor Fitzgerald.

普拉哈·阿格拉沃爾，坎托·菲茨杰拉德。

Hi, thank you for taking my questions and congrats on the quarter. So firstly, on subcu BRIUMVI, when is the phase pivotal trial expected to start. I think previously, you had mentioned targeting midyear 2025 as the time line. Is that still on track?

你好，感謝您回答我的問題，並祝賀本季取得佳績。那麼首先，關於皮下 BRIUMVI，關鍵階段試驗預計何時開始。我想您之前曾提到將 2025 年中期作為時間表。這仍然在進行中嗎？

And secondly, a question on BRIUMVI outside of MS, what do you need to see for BRIUMVI's profile and indications like myasthenia gravis to make the decision to invest further, especially given you have some income interesting data from the CD19 drugs in this space, especially Amgens.

其次，關於 BRIUMVI 在 MS 之外的應用，您需要了解 BRIUMVI 的哪些概況和適應症（如重症肌無力）才能做出進一步投資的決定，尤其是考慮到您從該領域的 CD19 藥物（尤其是安進公司）獲得了一些有趣的收入數據。

Yeah. Thanks, Prakhar. So in terms of subcu, yeah, still on track, as we said in the prepared remarks, still on track with the subcu timelines. And in terms of MG data. Yeah, I mean, we're definitely moving cautiously forward in that area.

是的。謝謝，普拉卡爾。因此，就 subcu 而言，是的，仍在按計劃進行，正如我們在準備好的評論中所說的那樣，仍在按照 subcu 時間表進行。就 MG 數據而言。是的，我的意思是，我們肯定會在該領域謹慎地前進。

We've been speaking to lots of KOLs, I will keep you here in the data, we'll get a chance to see how the CD19 is received in the marketplace. So I think we're not prepared to go diving into the pool just yet, but we've got more than a toe in, and we'll continue to evaluate.

我們已經與許多 KOL 進行了交談，我會在這裡向您提供數據，我們將有機會了解 CD19 在市場上的接受度。所以我認為我們還沒有準備好跳入游泳池，但我們已經邁出了第一步，並將繼續評估。

I don't think it's one piece of information. I think there's an aggregate of information. And I don't think most of that information is necessarily related to our drug and the performance of our drug. I think it's more related to the marketplace and how things evolve. So we are going to stay on top of it, we're going to keep pushing forward. in a moderate basis were an ability to accelerate at any moment, we feel the time is right.

我不認為這只是一條訊息。我認為這是一個資訊的集合。我不認為大部分資訊一定與我們的藥物及其性能有關。我認為這與市場以及事物的發展更加相關。因此，我們將保持領先地位，繼續前進。在適度的基礎上，我們隨時都有可能加速，我們認為時機已經成熟。

Got it. And maybe just one last question. What percentage of BRIUMVI patients right now are switches from Ocrevus? And is this a trend that you're seeing more of an inflection this year? And if so, why is that the case?

知道了。也許還有最後一個問題。目前，有多少比例的 BRIUMVI 患者是從 Ocrevus 轉換過來的？您認為今年這趨勢是否會有更大轉變？如果是這樣，為什麼會這樣？

Adam, you want to go ahead?

亞當，你想繼續嗎？

Yeah. We haven't seen -- I wouldn't say we've seen material changes in the percent of which is we still see a healthy amount of switches from Ocrevus. And that trend has stayed consistent since launch. So no material change, and I'm sorry, I don't remember the second part of the question. (multiple speakers)

是的。我們還沒有看到——我不會說我們已經看到了百分比的實質變化，但我們仍然看到了來自 Ocrevus 的健康數量的轉換。自推出以來，這一趨勢一直保持一致。所以沒有實質的變化，抱歉，我不記得問題的第二部分。（多位發言者）

Okay, thanks.

好的，謝謝。

At this time, I would like to turn the floor back over to Mr. Weiss for closing comments.

現在，我想把發言權交還給韋斯先生，請他發表最後評論。

Great. Thank you, operator, and everyone, thanks for joining us. As you can see, we're off to a very strong start in 2025. And we're looking forward to keeping that momentum positive going forward into the rest of the year.

偉大的。謝謝接線員，謝謝大家，謝謝你們的加入我們。如您所見，我們在 2025 年取得了非常強勁的開局。我們期待在今年剩餘時間繼續保持這種積極勢頭。

We've got a number of key objectives that we're still looking to achieve and we discussed on today's call, of course, meeting our revenue targets that we've set, commencing pivotal trials for a simplified starting dose for IV BRIUMVI and for subcu BRIUMVI as well as executing on our Phase 1 trials for BRIUMVI patients with myasthenia gravis and for azer-cel patients with progressive forms of MS.

我們還有一些關鍵目標需要實現，當然，我們在今天的電話會議上討論了實現我們設定的收入目標、開始對 IV BRIUMVI 和皮下 BRIUMVI 進行簡化起始劑量的關鍵試驗以及對患有重症肌無力的 BRIUMVI 患者和患有進行性 MS 的 azer-cel 患者進行 1 期試驗。

Beyond that, we continue to evaluate opportunities to expand our portfolio of product opportunities across autoimmune and autoinflammatory diseases and we'll continue our share buyback program.

除此之外，我們將繼續評估擴大自體免疫和自體發炎疾病產品組合的機會，並將繼續我們的股票回購計畫。

In closing, I want to extend a heartfelt thank you to all the individuals living with MS and health care providers to place their trust in TG and BRIUMVI. It their courage that inspires everything that we do here at TG. So we really do appreciate it. And again, thanks, everyone, for joining us today and have a nice day.

最後，我要向所有患有 MS 的個人和醫療保健提供者表示衷心的感謝，感謝他們對 TG 和 BRIUMVI 的信任。他們的勇氣激勵著我們在 TG 所做的一切。因此我們真的很感激。再次感謝大家今天的參與，祝福大家有愉快的一天。

Ladies and gentlemen, this concludes today's event. You may disconnect your lines or log off the webcast at this time, and enjoy the rest of your day.

女士們、先生們，今天的活動到此結束。現在您可以斷開線路或退出網路直播，享受剩餘的一天。