TG Therapeutics Inc (TGTX) 2025 Q2 法說會逐字稿

Greetings. Welcome to TG Therapeutics' second quarter earnings call and Webcast. (Operator Instructions) Please note, this conference is being recorded.

問候。歡迎參加 TG Therapeutics 第二季度收益電話會議和網路廣播。（操作員指示）請注意，本次會議正在錄音。

At this time, I'll turn the conference call over to Jenna Bosco, Chief Communications Officer. Jenna, you may now begin.

現在，我將把電話會議轉給首席通訊官詹娜·博斯科 (Jenna Bosco)。詹娜，你現在可以開始了。

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the second quarter 2025 financial results are Michael Weiss, our Chairman and Chief Executive Officer; Adam Waldman, our Chief Commercial 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 年第二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)、我們的首席商務官亞當·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 development. Adam will share an update on our commercial 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。亞當 (Adam) 將分享我們商業努力的最新進展，肖恩 (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 would 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. 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.

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。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。

This conference call is being recorded for audio rebroadcast on TG's website at www.tgtherapeutics.com, where will be available for the next 30 days.

此次電話會議將被錄音，並在 TG 的網站 www.tgtherapeutics.com 上重播，該網址將在未來 30 天內提供。

Now I would 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。

Thank you, Jenna, and good morning, everyone, and thank you for joining us on today's call. I'm pleased to share that we delivered another strong quarter with solid performance across all aspects of our business, highlighted by the continued momentum of our flagship product BRIUMVI. The ongoing enthusiasm from the MS community has been both gratifying and energizing and our commercial performance has exceeded expectations.

謝謝你，珍娜，大家早安，謝謝你們參加今天的電話會議。我很高興地告訴大家，我們又度過了一個強勁的季度，業務的各個方面都表現穩健，其中旗艦產品 BRIUMVI 的持續增長勢頭尤為突出。多發性硬化症 (MS) 患者群體的持續熱情令人欣慰且振奮，我們的商業表現也超出了預期。

At TG, our mission is to bring forward therapies that truly improve the lives of those living with multiple sclerosis, hearing real-world stories from individuals on BRIUMVI is both validating and deeply inspiring. I encourage you to visit briumvi.com to hear some of these patient experiences firsthand.

在 TG，我們的使命是提供真正改善多發性硬化症患者生活的治療方法，聽到 BRIUMVI 上個人的真實故事既令人欣慰又深受啟發。我鼓勵您訪問 briumvi.com 來直接了解一些患者的經歷。

Our commercial team remains disciplined and highly effective in executing our multiyear launch strategy. As a result, adoption continues to grow, now approximately 2.5 years into launch, we estimate that nearly 1 in every three new IV anti-CD20 patients are prescribed BRIUMVI. This represents meaningful progress for our long-term goal of making BRIUMVI the most prescribed anti- CD20 therapy for relapsing MS as measured by dynamic market share.

我們的商業團隊在執行多年發布策略時依然嚴謹且有效率。因此，採用率持續成長，目前距離推出約 2.5 年，我們估計每三名新的 IV 抗 CD20 患者中就有近 1 人被處方 BRIUMVI。這代表著我們的長期目標取得了有意義的進展，即使 BRIUMVI 成為以動態市場份額衡量的複發性 MS 最常用的抗 CD20 療法。

And as adoption continues to grow, we remain focused on expanding choice and flexibility for patients and providers through the development of subcu BRIUMVI in our ENHANCE study. The development of subcu BRIUMVI represents a strategic opportunity to further build a leadership role in the anti-CD20 space. If approved, subcu BRIUMVI would significantly expand our addressable market by unlocking access to the 35% to 40% of the anti-CD20 dynamic market segment that currently prefers a self-administered option, of which only one is available today. We believe subcu BRIUMVI has the potential to offer a highly valued alternative for both patients and providers.

隨著採用率的不斷增長，我們將繼續致力於透過在 ENHANCE 研究中開發皮下 BRIUMVI 來擴大患者和提供者的選擇和靈活性。subcu BRIUMVI 的發展代表著進一步在抗 CD20 領域建立領導地位的策略機會。如果獲得批准，subcu BRIUMVI 將顯著擴大我們的目標市場，讓我們能夠進入 35% 至 40% 的抗 CD20 動態市場，該市場目前傾向於自我管理選項，而目前只有一種可供選擇。我們相信，subcu BRIUMVI 有潛力為患者和提供者提供高度有價值的替代方案。

Moreover, it would uniquely position TG as the only company offering both an IV and a self-administered option, potentially simplifying the treatment decision for patients and providers and positioning BRIUMVI as the anti-CD20 therapy of choice.

此外，它將使 TG 成為唯一一家同時提供靜脈注射和自我給藥選項的公司，這可能簡化患者和提供者的治療決策，並將 BRIUMVI 定位為首選的抗 CD20 療法。

Supporting this vision, the team has executed exceptionally well on our clinical development goals this quarter, putting us on track to initiate patient enrollment into our pivotal Phase III trial for subcu BRIUMVI in the coming weeks. This study will evaluate two dosing schedules every other month and quarterly. Compared to IV BRIUMVI in patients with relapsing forms of MS. The primary endpoint is to demonstrate non-inferior exposure between subcu dosing and our approved IV dosing.

為了支持這個願景，團隊本季出色地完成了我們的臨床開發目標，使我們能夠在未來幾週內開始招募患者參與皮下 BRIUMVI 的關鍵 III 期試驗。這項研究將每隔一個月和每季評估兩種給藥方案。與復發型 MS 患者的 IV BRIUMVI 相比。主要終點是證明皮下給藥與我們批准的靜脈給藥之間的非劣效暴露。

We anticipate completing enrollment in 2026, filing a BLA in 2027 and pending approval, launching a subcu BRIUMVI in 2028. At the same time, we're focused on enhancing the patient experience with IV BRIUMVI. I'm pleased to report that within the ENHANCE trial, we have begun enrollment into a randomized, double-blind Phase III cohort evaluating the potential to consolidate the day 1 and day 15 infusions into a single 600-milligram infusion on day one.

我們預計將於 2026 年完成註冊，2027 年提交 BLA 並等待批准，然後在 2028 年推出子課程 BRIUMVI。同時，我們致力於透過 IV BRIUMVI 提升患者體驗。我很高興地報告，在 ENHANCE 試驗中，我們已經開始招募隨機、雙盲 III 期隊列，評估將第 1 天和第 15 天的輸液合併為第一天的單次 600 毫克輸液的可能性。

The goal of this study is to establish comparable exposure between the two dosing schedules. If successful, a simplified approach would eliminate the need for a second infusion in the first two weeks, offering what we believe would be a meaningful convenience benefit for patients and infusion centers. We look forward to pivotal data in 2026 with the goal of an updated label in 2027.

本研究的目的是確定兩種給藥方案之間的可比較暴露量。如果成功的話，簡化的方法將消除前兩週第二次輸液的需要，我們相信這將為患者和輸液中心帶來有意義的便利。我們期待 2026 年獲得關鍵數據，並目標是 2027 年更新標籤。

Turning briefly to our pipeline. We are also pleased to share that we have dosed our first patient with progressive MS using azer-cel our investigational allogeneic CD19-directed CAR-T therapy. In parallel, we continue to explore the use of BRIUMVI in myasthenia gravis as we consider additional opportunities to expand the uses of BRIUMVI.

簡要介紹一下我們的管道。我們也很高興地告訴大家，我們已經為我們的第一位患有進行性 MS 的患者使用了我們研究性的同種異體 CD19 導向 CAR-T 療法 azer-cel。同時，我們將繼續探索 BRIUMVI 在重症肌無力中的應用，並考慮擴大 BRIUMVI 用途的更多機會。

This is an exciting time at TG. Our results this quarter reflect strong execution across both commercial and clinical fronts and a growing confidence in BRIUMVI from physicians and patients alike. With continued progress on our subcu program, enhancements to the IV experience and the advancement of our CD19 CAR-T into the clinic, we're laying the groundwork for sustained leadership in the MS space.

這是 TG 激動人心的時刻。本季的業績反映了我們在商業和臨床方面的強勁執行力，以及醫生和患者對 BRIUMVI 的信心日益增強。隨著我們的皮下注射計劃不斷取得進展、靜脈注射體驗的增強以及 CD19 CAR-T 進入臨床，我們正在為在 MS 領域的持續領導地位奠定基礎。

With that, I'll now turn the call over to Adam Waldman, our Chief Commercial Officer, who will provide additional insights into our commercial performance and updated guidance for the second half of the year. Adam, go ahead.

現在，我將把電話轉給我們的商務長亞當‧沃爾德曼 (Adam Waldman)，他將對我們的商業表現提供更多見解，並為下半年提供最新指導。亞當，繼續吧。

Thank you, Mike, and good morning, everyone. I'm excited to report that Q2 2025 was another strong quarter for TG Therapeutics, marked by continued commercial momentum, executional excellence and the highest number of new patient enrollments into our hub since launch. We're now seeing the tangible results of our strategic investments as the foundation we've built continues to scale.

謝謝你，麥克，大家早安。我很高興地報告，2025 年第二季度對於 TG Therapeutics 來說又是一個強勁的季度，其特點是持續的商業勢頭、卓越的執行力以及自推出以來我們中心新患者登記數量最多。隨著我們建立的基礎不斷擴大，我們現在看到了策略投資的實際成果。

US net sales for BRIUMVI in Q2 totaled approximately $139 million, ahead of our internal expectations and building on the robust growth we achieved in Q1, positioning us for a strong second half of 2025. Several key performance drivers reinforce our confidence in the brand's continued trajectory. We saw a meaningful increase in both new prescribers and new accounts, reflecting deeper penetration across academic institutions and community neurology practices.

BRIUMVI 在美國第二季度的淨銷售額總計約為 1.39 億美元，超出了我們的內部預期，並基於我們在第一季度實現的強勁增長，為我們在 2025 年下半年的強勁表現奠定了基礎。幾個關鍵的業績驅動因素增強了我們對該品牌持續發展軌蹟的信心。我們發現新開處方者和新帳戶數量都有顯著增長，這反映了學術機構和社區神經病學實踐的更深層滲透。

Q2 marked our highest volume of new patient enrollments to date, a clear indicator that our reach is expanding and that awareness among providers and patients is accelerating.

第二季度是我們迄今為止新患者登記量最高的季度，這清楚地表明我們的覆蓋範圍正在擴大，醫療服務提供者和患者的認知度正在提高。

We also continue to observe strong persistence and repeat prescribing, which we view as a validation of BRIUMVI's differentiated clinical profile and its value in real-world practice. Today, the CD20 class generates over $8 billion in annual US MS sales and continues to grow. BRIUMVI is steadily increasing its share within this expanding market.

我們也繼續觀察到強大的持久性和重複處方，我們認為這是對 BRIUMVI 差異化臨床特徵及其在現實世界實踐中的價值的驗證。如今，CD20 類藥物每年為美國多發性硬化症 (MS) 患者帶來超過 80 億美元的銷售額，並且持續成長。BRIUMVI 正在穩步增加其在這個不斷擴大的市場中的份額。

As Mike mentioned earlier, we estimate that nearly one-third of new patients initiating IV anti-CD20 therapy are being prescribed BRIUMVI. We believe there remains significant headroom for continued growth for the class and for BRIUMVI within it.

正如 Mike 之前提到的，我們估計，在開始接受靜脈注射抗 CD20 治療的新患者中，有近三分之一的人被處方了 BRIUMVI。我們相信，該類別以及其中的 BRIUMVI 仍有很大的持續成長空間。

Our competitive advantage remains clear, a convenient twice a year, 1-hour infusion, combined with 5-year safety and efficacy data collectively offers a compelling treatment option for RMS patients. These differentiators continue to resonate strongly across care settings from large academic centers to private practices to the VA system, where we continue to be the preferred anti-CD20 therapy.

我們的競爭優勢依然明顯，每年兩次、每次 1 小時的便捷輸液，加上 5 年的安全性和有效性數據，為 RMS 患者提供了引人注目的治療選擇。這些差異化因素繼續在從大型學術中心到私人診所到 VA 系統的醫療環境中產生強烈共鳴，在這些系統中，我們仍然是首選的抗 CD20 療法。

A major milestone this quarter was the launch of our first-ever national television campaign. This initiative is part of a broader multichannel strategy that will ramp throughout the second half of the year with the goal of driving patient awareness.

本季的一個重要里程碑是我們首次啟動全國電視宣傳活動。這項措施是更廣泛的多通路策略的一部分，該策略將在今年下半年逐步實施，目的是提高患者意識。

While it's still early, we're seeing promising signs of the investment is having an impact. Our latest market research shows a measurable uptick in patient awareness of BRIUMVI. Website traffic, branded organic search impressions, branded paid search impressions and qualified visitors to the website have all increased meaningfully.

雖然現在還為時過早，但我們看到了投資正在產生影響的跡象。我們最新的市場調查顯示，患者對 BRIUMVI 的認知度顯著提高。網站流量、品牌自然搜尋印象、品牌付費搜尋印象和網站合格訪客數量均有顯著增加。

And importantly, physicians are reporting more patients requesting BRIUMVI by name. We are closely tracking key performance indicators across media channels, and we'll continue to monitor performance, but early signals are encouraging.

重要的是，醫生報告說，越來越多的患者指名請求 BRIUMVI。我們正在密切追蹤各個媒體管道的關鍵績效指標，並將繼續監控其表現，但早期訊號令人鼓舞。

I also want to highlight the efforts of our commercial team. We believe we have a highly effective field team and our recent surveys backed that up with consistently high ratings when compared to our peers in the MS space. Their ability to clearly incredibly communicate BRIUMVI's value proposition is a key part of our strategy and their daily commitment is making a real difference.

我也想強調一下我們商業團隊的努力。我們相信我們擁有一支高效的現場團隊，我們最近的調查也證實了這一點，與 MS 領域的同行相比，我們的評分始終很高。他們能夠清晰、令人難以置信地傳達 BRIUMVI 的價值主張，這是我們策略的關鍵部分，而他們每天的承諾正在產生真正的影響。

Looking ahead, we are confident in the continued growth of BRIUMVI revenues. Based on current trends in both new patient prescriptions and persistence of existing patients, we are again raising our full year US BRIUMVI net revenue guidance which was $560 million to $570 million to $575 million for the full year 2025.

展望未來，我們對 BRIUMVI 收入的持續成長充滿信心。根據新患者處方和現有患者的堅持情況的當前趨勢，我們再次上調美國 BRIUMVI 全年淨收入預期，即 2025 年全年為 5.6 億美元至 5.7 億美元至 5.75 億美元。

Similar to last year, given expected Q3 seasonality we would expect stronger growth Q3 to Q4 than Q2 to Q3. With multiple growth drivers in place, expanding patient and prescriber bases, increasing brand recognition and the momentum of our media investments, we believe BRIUMVI is on track to become a multibillion- dollar brand in relapsing MS.

與去年類似，考慮到預期的第三季季節性，我們預計第三季至第四季的成長將比第二季至第三季更加強勁。隨著多種成長動力的到位、患者和處方者基礎的擴大、品牌知名度的提高以及媒體投資的勢頭，我們相信 BRIUMVI 有望成為復發性 MS 領域價值數十億美元的品牌。

To summarize, Q2 was another quarter of commercial strength, execution and strategic progress. We expect a strong second half of the year. With that, I'll turn it over to Sean to walk through the financials.

總而言之，第二季又是一個商業實力、執行力和策略進展的季度。我們預計今年下半年業績將表現強勁。說完這些，我會把問題交給肖恩來介紹財務狀況。

Thank you, Adam, and good morning, everyone. Earlier this morning, we reported our detailed second quarter 2025 financial results via 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，我們透過新聞稿報告了 2025 年第二季的詳細財務業績，該新聞稿可在我們網站的「投資者和媒體」部分查閱。

Let's start by taking a closer look at our revenue performance, which continues to demonstrate strong growth and commercial momentum. We're very pleased to report total revenue of $141.1 million for the second quarter of 2025, which includes US net product revenue of $138.8 million, representing a 91% increase compared to the same period last year, and 16% growth over the first quarter of this year.

首先讓我們仔細看看我們的收入表現，它繼續表現出強勁的成長和商業勢頭。我們非常高興地報告 2025 年第二季的總收入為 1.411 億美元，其中包括美國淨產品收入 1.388 億美元，比去年同期增長 91%，比今年第一季增長 16%。

This strong performance reflects the continued uptake and demand for BRIUMVI and highlights our team's success and execution across the commercial landscape. Additionally, we recorded $2.3 million in license, milestone and royalty revenue this quarter.

這一強勁表現反映了對 BRIUMVI 的持續接受和需求，並凸顯了我們團隊在整個商業領域的成功和執行力。此外，本季我們獲得了 230 萬美元的許可、里程碑和特許權使用費收入。

Turning to our expenses. Our total OpEx defined as R&D and SG&A costs, excluding noncash compensation, totaled approximately $71 million for the second quarter of 2025. This represents an increase from $46.9 million in Q2 of '24, but a decrease of about $10 million compared to the first quarter of this year. The year-over-year increase was primarily driven by ongoing investments in R&D, particularly related to the development of a subcutaneous formulation of BRIUMVI, as well as our continued commercial efforts on the SG&A side.

談到我們的開支。我們的總營運支出定義為研發及銷售、一般及行政費用（SG&A），不包括非現金補償，2025 年第二季總計約 7,100 萬美元。這比 24 年第二季的 4,690 萬美元有所增加，但與今年第一季相比減少了約 1,000 萬美元。年比成長主要得益於持續的研發投資，特別是與 BRIUMVI 皮下製劑開發相關的投資，以及我們在銷售、一般及行政費用 (SG&A) 方面的持續商業努力。

In contrast, the sequential decline from Q1 was largely due to the timing of subcutaneous BRIUMVI development activities, which we expect will continue to have some quarter-to-quarter variability. With all that said, we continue to expect full year operating expenses to be in the range of approximately $300 million in line with our prior guidance.

相較之下，第一季的環比下降主要是由於皮下 BRIUMVI 開發活動的時間安排，我們預計活動將繼續出現一些季度間差異。儘管如此，我們仍然預計全年營運費用將在約 3 億美元左右，與我們先前的預期一致。

On the bottom line, we're pleased to report GAAP net income of $28.2 million, or $0.17 per diluted share for the quarter ended June 30, 2025, as compared to $6.9 million in net income or $0.04 per diluted share for the second quarter of '24.

總而言之，我們很高興地報告，截至 2025 年 6 月 30 日的季度，GAAP 淨收入為 2820 萬美元，即每股攤薄收益 0.17 美元，而 2024 年第二季度的淨收入為 690 萬美元，即每股攤薄 0.04 美元。

And finally, a quick note on our balance sheet. We closed the quarter with approximately $279 million in cash, cash equivalents and investment securities, which is essentially flat from the first quarter. We believe this strong capital position enables us to continue executing on our long-term strategy while preserving flexibility for future investments in our pipeline and operations.

最後，簡單介紹一下我們的資產負債表。本季末，我們持有約 2.79 億美元的現金、現金等價物和投資證券，與第一季基本持平。我們相信，強大的資本狀況使我們能夠繼續執行我們的長期策略，同時為未來在管道和營運方面的投資保留靈活性。

In summary, the second quarter was a success on multiple fronts with strong results, both operationally and financially. With that, I will now turn the call over to the conference operator to begin the Q&A.

總而言之，第二季度在多個方面都取得了成功，營運和財務方面都取得了強勁的業績。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。

So I'm curious about guidance. It implies a little bit of leveling off of growth in the back half of the year. So I'm curious to get your thoughts a little bit more elaboration on what various headwinds and tailwinds that we could expect in Q3 and Q4 to get a better idea of cadence for the rest of the year.

所以我對指導感到好奇。這意味著下半年經濟成長將略微趨於平穩。因此，我很好奇，想進一步了解您對第三季和第四季可能遇到的各種不利因素和有利因素的看法，以便更好地了解今年剩餘時間的節奏。

Sure. Adam, do you want to take that one?

當然。亞當，你想拿那個嗎？

Sure. Thanks for the question, Tara. We're raising guidance here. And as I mentioned in the prepared remarks, we do see seasonality in the summer. We accounted for that in the guidance and we expect stronger growth from Q3 to Q4. And I think the success we've had in the first year with increased enrollments and persistence in week '24 and week 48 are driving our need to increase the overall guidance for the year.

當然。謝謝你的提問，塔拉。我們在此提高指導。正如我在準備好的演講中提到的那樣，我們確實看到了夏季的季節性。我們在指導下考慮到了這一點，我們預計第三季至第四季的成長將更加強勁。我認為，我們在第一年取得的成功，入學人數的增加以及第 24 週和第 48 週的堅持，促使我們需要提高今年的整體指導。

Michael DiFiore with Evercore ISI.

Evercore ISI 的 Michael DiFiore。

Congrats on the strong quarter. Just two for me. I was wondering if you could expand upon comments you recently made at a broker conference where you said that 40% of CD20 new starts now opt for an at-home subcu. My question is, how would you say the remaining 60% is broken down in terms of those opting for BRIUMVI versus the other competitors, IV and subcu formulations?

恭喜本季業績強勁。對我來說只要兩個。我想知道您是否可以詳細說明您最近在經紀人會議上發表的評論，您說現在 40% 的 CD20 新創公司選擇在家中進行皮下注射。我的問題是，對於選擇 BRIUMVI 而不是其他競爭對手的 IV 和皮下製劑的人群，您認為剩下的 60% 是如何分佈的？

And second question is just given the growing payer push for lower-cost at-home therapies, like are you seeing any early signs that the demand for subcu could actually outpace IV? And do you think that payers could accelerate that shift in the next year or two?

第二個問題是，鑑於越來越多的付費用戶要求採用低成本的家庭療法，您是否看到任何早期跡象表明皮下注射的需求實際上可能超過靜脈注射？您是否認為付款人可以在未來一兩年內加速這種轉變？

Thank you.

謝謝。

Thanks, Mike. Adam, do you want to give a crack here and I could always add on, but I think this one is right in your warehouse.

謝謝，麥克。亞當，你想在這裡試試看嗎？我可以隨時添加，但我認為這個就在你的倉庫裡。

Yes. Sure. Thanks for the question, Michael. So the first question on the 60% that are IV, as I mentioned, we believe in the IV segment or physician-administered segment. We're capturing about 1 out of every three patients today. And the other competitors are getting the other part of that market.

是的。當然。謝謝你的提問，麥可。因此，第一個問題是關於 60% 的 IV，正如我所提到的，我們相信 IV 部分或醫生管理的部分。今天我們接診了大約三分之一的患者。其他競爭對手正在佔領該市場的另一部分。

As far as the payer questions, we're not seeing it today, but certainly, we could see it. It's certainly possible. Hence, the reason we are actively developing our own subcu to participate in that segment of the market.

至於付款人的問題，我們今天沒有看到，但當然，我們可能會看到。這當然是有可能的。因此，我們積極開發自己的子系統以參與該細分市場。

Thank you.

謝謝。

Corinne Jenkins, Goldman Sachs.

高盛的科琳‧詹金斯 (Corinne Jenkins)。

Good morning. Maybe could you talk a little bit more about the administration of the subcutaneous product you're developing, will it be auto-injector or prefilled syringe? And what additional work do you need to do on the device side in terms of getting that -- the development through to outperform? Thanks.

早安.也許您可以再多談談您正在開發的皮下產品的管理，它是自動注射器還是預充式註射器？為了實現這一目標，您還需要在設備方面做哪些額外的工作—實現超越？謝謝。

Yes, sure. Thanks for the question. So yes, so as typical for these kinds of programs, the main study will be conducted with the -- basically a syringe pulls from a vial to get the bioequivalent. And then there's usually a bridging study to either a prefilled syringe and, or to an auto-injector. I think our plan is probably just go straight to the auto-injector.

是的，當然。謝謝你的提問。是的，對於這類計畫來說，主要研究將採用——基本上是用注射器從小瓶中抽取生物等效物來進行。然後通常會對預充式註射器或自動注射器進行橋接研究。我認為我們的計劃可能就是直接使用自動注射器。

And so there'll be a bridging study that's part of the program. But that's all sort of in the time lines that we provided in terms of our target for a filing in '27 and hopefully, an approval in '28. But yes, it starts off as injections from a vial and then bridges to the auto-injector.

因此，該計劃中將會有一項銜接研究。但這一切都在我們設定的時間表內，我們的目標是在 27 年提交申請，並希望在 28 年獲得批准。但是的，它首先從小瓶注射，然後橋接到自動注射器。

The auto-injector we're using is a, call it, relatively standard. It's been in tens of thousands of patients in multiple drug launches, multiple major drug launches. So it's a pretty well known, pretty well-accepted auto-injector. And I think there's the basic development that goes along with that. But I don't think we're expecting any technical challenges with the auto-injector.

我們使用的自動注射器是一種相對標準的注射器。在多次新藥發布、多次重大新藥發布中，已有數萬名患者使用了該藥物。所以它是一種非常知名、廣為接受的自動注射器。我認為這是伴隨而來的基本發展。但我認為我們不會遇到任何自動注射器的技術挑戰。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley 證券。

Yes. Congrats on the progress. One more on the second half revenue guidance. Could you touch on how you're assuming the anti- CD20 IV overall market trends, including your belief on how new patient starts might be trending for ZUNOVO OCREVUS? And then I have a quick follow-up.

是的。恭喜你取得進展。再談一下下半年的收入預期。您能否談談您如何看待抗 CD20 IV 的整體市場趨勢，包括您對 ZUNOVO OCREVUS 新患者開始趨勢的看法？然後我有一個快速的跟進。

Adam, do you want to go ahead on this one, too?

亞當，你也想繼續這個嗎？

Sure. Yes. Thanks for the question, Mike. We're not seeing a lot of enthusiasm for the ZUNOVO product in the US We continue -- I think the biggest point here is that we continue to grow new patient enrollments. We've continued to grow through the launch. We've continued to grow through the ASP or the -- sorry, the J-code -- the permanent J-code that was granted in April. So we're not really seeing any impact on us in terms of the ZUNOVO product, and we're seeing overall limited enthusiasm for that drug.

當然。是的。謝謝你的提問，麥克。我們在美國沒有看到人們對 ZUNOVO 產品的熱情，我們繼續下去——我認為這裡最重要的一點是我們繼續增加新患者的註冊數量。透過產品發布，我們繼續成長。我們透過 ASP 或說——抱歉，是 J 代碼——四月授予的永久 J 代碼——繼續發展。因此，我們實際上並沒有看到 ZUNOVO 產品對我們產生任​​何影響，而且我們對該藥物的熱情總體有限。

The overall market, you think is stable for IV and steadily growing or it's just flat? Can you comment on that, Adam?

您認為整體市場對於 IV 是穩定的並且穩定成長還是持平？亞當，您能對此發表評論嗎？

Yes, sure. It's about -- I think it's leveled out here at about 60 -- 60-40, 65-35.

是的，當然。大約是——我認為這裡的穩定度大約是 60——60-40，65-35。

Okay. And then on ECTRIMS, I believe in the same session, we are getting the 6-year ULTIMATE I and II trial data set, we're also getting the anti-CD19 CAR T, I believe, a single center, primary progressive early data set. Mike, any thoughts on what your expectations are with some of the early human data that could inform your own azer-cel development?

好的。然後在 ECTRIMS 上，我相信在同一次會議上，我們將獲得 6 年 ULTIMATE I 和 II 試驗數據集，我們還將獲得抗 CD19 CAR T，我相信，這是一個單中心、原發性進展早期數據集。麥克，對於一些可以用於您自己的 azer-cel 開發的早期人類數據，您有何期望？

Probably not so much. I mean I think all the data is going to be extremely early, and we'll see. I think those programs and our program are early. There's a lot of time to develop them. And I think in MS, it's not going to be a short-term kind of development program. So if any of the things they're going to do something relatively quickly there. They're probably maybe off pace. But we'll see.

可能沒那麼多。我的意思是，我認為所有數據都將非常早期，我們拭目以待。我認為那些計劃和我們的計劃都還為時過早。有很多時間來開發它們。我認為在 MS，這不會是一個短期的發展計劃。因此，如果他們要做任何事情，他們都會相對快速地採取行動。他們可能已經落後了。但我們會看到。

But anyway, yes, I don't think there's going to be too much that's going to change how we think about how we're developing the drug. I think we've got a pretty clear focus on what we want to achieve, and we'll see if we can get there.

但無論如何，是的，我認為不會有太多事情改變我們對如何開發藥物的看法。我認為我們已經非常明確地專注於我們想要實現的目標，我們將看看是否能夠實現它。

Roger Song, Jefferies.

傑富瑞 (Jefferies) 的羅傑宋 (Roger Song)。

This is Cha Cha Yang on for Roger. I had a question about whether you could touch on product adherence versus the biannual infusions. And then my second question is, maybe I missed this, if you could give 3Q guidance, perhaps I missed that at the beginning of your call.

這是 Cha Cha Yang 為 Roger 表演的。我有一個問題，您是否可以談談產品依從性與每半年一次的輸液。我的第二個問題是，也許我錯過了這一點，如果您能給出第三季度指導，也許我在通話開始時錯過了這一點。

Yes. Adam, you want to go ahead --

是的。亞當，你想繼續--

Can you please repeat the second half of that question?

您能重複一下這個問題的後半部嗎？

So about 3Q guidance?

那麼關於第三季的指導呢？

Yes. Sorry, I didn't hear the last part of it.

是的。抱歉，我沒有聽到最後部分。

I was just wondering, potentially I missed it, but did you guys give Ry guidance, if not, could you give some color on that?

我只是想知道，我可能錯過了，但你們有沒有給過 Ry 指導，如果沒有，你能提供一些說明嗎？

Yes. No, we did not give 3Q guidance or Q3 guidance. We are giving full year guidance similar to what we did last year. We gave you insight into what we feel is the growth trend from Q2 to Q3. And in Q3 to Q4, but we're not giving specific Q3 guidance here.

是的。不，我們沒有提供第三季指引或第三季指引。我們給出的全年指引與去年類似。我們向您介紹了我們認為的第二季到第三季的成長趨勢。在第三季度到第四季度，但我們在這裡沒有給出具體的第三季度指引。

Okay. And then can you give some color on the product adherence part versus the infusions.

好的。然後，您能否對產品依從性部分與輸注部分進行一些說明。

Sure. I mean what we've seen is that our persistence continues to be good, both at week 24, and we're getting preliminary data here at week 48, continues to be above our expectations and slightly above where we would expect it to be based on published data that's out there for other CD20s that is.

當然。我的意思是，我們看到我們的持久性繼續保持良好，無論是在第 24 週，還是我們在第 48 週獲得的初步數據，都繼續超出我們的預期，並且略高於我們根據其他 CD20 的已發布數據所預期的水平。

Prakhar Agrawal with Cantor Fitzgerald.

普拉哈·阿格拉瓦爾和康托·菲茨杰拉德。

Congrats on the quarter again. So firstly, on the subcu BRIUMVI, it seems that you're also comfortable with the quarterly dosing here. Maybe if you can comment what you saw in Phase I for the quarterly dosing frequency? And what will the injection volume for both quarterly and every other month dosing? Also, when can we see the subcu Phase I data? And I have a follow-up.

再次恭喜本季取得佳績。首先，關於皮下注射 BRIUMVI，您似乎也對這裡的季度劑量感到滿意。也許您可以評論一下您在第一階段看到的季度給藥頻率的情況？每季和每隔一個月注射的注射量是多少？另外，我們什麼時候可以看到 subcu 第一階段的資料？我還有一個後續問題。

And you have a follow-up. Okay. Thanks, Prakhar for the question. On the subcu dosing, yes, I mean, look, in terms of quarterly dosing and monthly -- and every other monthly dosing, we've got preliminary bioavailability information that leads us to believe that both are achievable, certainly every other month and quarterly as well. We haven't provided that information just yet.

你還有後續行動。好的。謝謝 Prakhar 提出這個問題。關於皮下注射劑量，是的，我的意思是，就每季度和每月的劑量以及每隔一個月的劑量而言，我們已經獲得了初步的生物利用度信息，這使我們相信兩者都是可以實現的，當然每隔一個月和每季度也是如此。我們尚未提供該資訊。

In terms of volume, typical auto injectors, max, basically two mls of volume, so we'll probably be pretty close to that. But yes, I think for the moment, what we've said is we're comfortable that what we've seen with the bioavailability it should support every other month, and as I said in the per pared remarks, potentially quarterly as well.

就容量而言，典型的自動注射器的最大容量基本上是兩毫升，所以我們可能非常接近這個數字。但是的，我認為目前，我們所說的是，我們對所看到的生物利用度感到滿意，它應該每隔一個月支持一次，並且正如我在準備好的評論中所說的那樣，也可能每季度支持一次。

And you had a follow-up?

你有後續行動嗎？

Yes. Got it. So on the second quarter sequential growth of 16%, how much is volume versus pricing? And if you can comment on the gross net trends for the rest for the year.

是的。知道了。那麼，第二季連續 16% 的成長中，銷量與價格的比率是多少？您是否可以評論一下今年剩餘時間的總淨趨勢？

Thank you so much.

太感謝了。

Sure. Yes. I think that's one for Adam.

當然。是的。我想這對亞當來說就是這樣的。

Sure. Thanks for the question, Prakhar. On the gross to net, I'll take that first. We've guided 70% to 75% for the year and that still remains intact. I would say this quarter, it was probably closer to 70%. And the reason for that is that we -- our fastest-growing segment is the hospital segment, and we continue to see growth in that segment of the market. And with that comes a mandated government discounting or more exposure to government mandated discounting, like 340B discounting, which kind of affect your gross to net.

當然。謝謝你的提問，Prakhar。就總收入與淨收入而言，我首先會考慮這一點。我們預計今年的成長率將達到 70% 至 75%，而這一目標仍保持不變。我想說本季，這個比例可能接近 70%。原因在於，我們成長最快的部分是醫院部分，我們繼續看到該部分市場的成長。隨之而來的是政府強制折扣或更多的政府強制折扣，例如 340B 折扣，這會影響您的毛利與淨利。

So we did see gross to net probably closer to 70% in this quarter, but the guidance that I've given for the year between 70% and 75% is still accurate. But in this quarter, it was probably closer to 70%. And was that the -- was there any -- what was the second part of that question?

因此，我們確實看到本季的毛利率可能接近 70%，但我對全年 70% 至 75% 之間的預測仍然準確。但本季度，這一比例可能接近 70%。那是——有——這個問題的第二部分是什麼？

Yes. How much of the 16% sequential growth is volume versus price?

是的。16% 的環比成長中有多少是銷量成長，有多少是價格成長？

Yes. I don't have that exactly broken down, but mostly volume.

是的。我沒有將其精確地分解，但主要是體積。

At this time, we've reached the end of the question-and-answer session. I'll turn the call over to Mike Weiss for closing remarks.

至此，問答環節已經結束。我將把電話轉給邁克·韋斯 (Mike Weiss) 做最後發言。

Thank you very much, operator, and thank you all again for joining us today. As you've heard, this quarter highlights the strength of our commercial execution, the growing demand for BRIUMVI and a significant opportunity ahead as we continue to expand our

非常感謝，接線員，再次感謝大家今天加入我們。正如您所聽到的，本季度凸顯了我們商業執行的實力、對 BRIUMVI 不斷增長的需求以及我們繼續擴大業務的重大機遇

presence in MS. We believe TG is well positioned to drive meaningful near-term growth while also shaping the future of MS care through differentiated options across IV, subcu and potentially cell therapy, laying the foundation for sustained growth and long-term shareholder value.

存在於 MS 中。我們相信，TG 完全有能力推動有意義的短期成長，同時透過靜脈注射、皮下注射和潛在細胞療法的差異化選擇塑造 MS 照護的未來，為持續成長和長期股東價值奠定基礎。

Most importantly, our focus remains firmly on delivering for patients and we look forward to keeping you updated on our continued progress in the quarters ahead. Thanks again for joining us, and have a great day.

最重要的是，我們的重點始終是為患者提供服務，我們期待在未來幾季向您通報我們持續取得的進展。再次感謝您的加入，祝您有個愉快的一天。

Thank you. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.

謝謝。今天的會議到此結束。現在您可以斷開線路。感謝您的參與。