TG Therapeutics Inc (TGTX) 2024 Q3 法說會逐字稿

Greetings and welcome to the TG Therapeutics third quarter conference call and webcast. At this time, all participants are in listen-only mode.

問候並歡迎參加 TG Therapeutics 第三季度電話會議和網路廣播。此時，所有參與者都處於只聽模式。

If anyone should require operator assistance, please press star zero on your telephone keypad.

如果有人需要接線生的幫助，請按電話鍵盤上的星號零。

A question-and-answer session will follow the formal presentation. You may be placed in the question queue at any time by pressing star one on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Jenna Bosco. Please go ahead.

正式演講結束後將進行問答環節。您可以透過按下電話鍵盤上的星號 1 隨時加入到提問佇列。提醒一下，本次會議正在錄音。現在我很高興將電話轉給詹娜·博斯科 (Jenna Bosco)。請繼續。

Thank you, welcome everyone and thanks for joining us this morning. I'm Jenna Bosco and with me today to discuss the third quarter, 2024 financial results are Michael Weiss, our Chairman and Chief Executive Officer, Adam Waldman, our Chief Commercialization Officer and Sean Power, our Chief Financial Officer following our safe harbor statement. Mike will provide an overview of our recent corporate developments.

謝謝，歡迎大家，謝謝大家今天早上加入我們。我是詹娜·博斯科 (Jenna Bosco)，今天與我一起討論 2024 年第三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)，遵循我們的安全港聲明。麥克將概述我們最近的公司發展。

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 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 1,995. 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 product. 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.

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，然後在我們開始之前將電話轉給接線員開始問答環節。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有關我們預期的未來營運和財務表現的陳述，包括銷售業績、預計的里程碑、收入指導、發展計劃和對我們行銷產品的期望。TG 警告稱，這些前瞻性聲明存在風險，可能會導致我們的實際結果與可能影響 TG 治療的因素有重大差異。營運包括各種風險因素，可以在我們的證券交易文件中找到。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。

We specifically disclaim, disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on tg's website www dot TG therapeutics dotcom where it will be available for the next 30 days. With that. I'd like to turn the call over to Michael Weiss, our CEO.

我們明確否認、不承擔更新或修改任何前瞻性陳述的義務。本次電話會議將被錄音，並在 tg 的網站 www.tgtherapy.com 上重播，並將在接下來的 30 天內提供。就這樣。我想將電話轉給我們的執行長邁克爾·韋斯。

Thank you, Jenna and good morning, everyone and thank you for joining us for our quarterly earnings call. We're excited to share with you the results of another quarter of growth and execution of our Bonni. Launch the positive feedback and uptake for BRIUMVI in the marketplace continues to outpace our expectations and the strong data presented during the annual meeting from the ultimate one and two trials and the enhanced phase three B trial, both evaluating BRIUMVI and individuals with relapsing forms of MS continues to strengthen our belief in the long-term value of Ryam.

謝謝你，詹娜，大家早安，謝謝你們參加我們的季度財報電話會議。我們很高興與您分享 Bonni 另一個季度的成長和執行成果。市場上對 BRIUMVI 的正面回饋和接受度繼續超出我們的預期，而年度會議上呈現的最終一期和二期試驗以及增強型三期 B 試驗的強有力數據（均對 BRIUMVI 和復發型 MS 患者進行評估）繼續增強了我們對 Ryam 長期價值的信心。

We remain highly focused on the commercial success am excited to share with you our current progress as well as our future plans to continue to grow and shareholder value.

我們仍然高度關注商業成功，並很高興與您分享我們目前的進展以及我們未來的持續成長和股東價值計劃。

Let's kick things off with a brief review of the quarterly sales. I'm happy to report that we on the third quarter US net sales were $83.3 million.

讓我們先簡單回顧一下季度銷售情況。我很高興地報告，我們第三季美國淨銷售額為 8,330 萬美元。

Adam Waldman, our Chief Commercialization Officer will join shortly to write a full commercial update and hearing guidance. But I wanted to say that I'm extremely pleased with the continued commercial launch effort. The team continues to execute on our phased launch plan setting us on what we believe is a path for continued growth and strong momentum heading into the end of the year and into 2025 and further toward our long term goal of becoming the number one prescribed anti CD 20 in terms of dynamic market share.

我們的首席商業化長 Adam Waldman 很快就會加入並撰寫完整的商業更新和聽證指導。但我想說的是，我對持續的商業發布努力感到非常高興。團隊繼續執行我們的分階段發布計劃，我們相信這將使我們走上一條持續增長和強勁發展勢頭的道路，並預計在年底和 2025 年繼續朝著我們的長期目標邁進，即成為動態市場份額排名第一的抗 CD 20 處方藥。

To that end. Let's discuss some of the BRIUMVI, the data presented at the recent REMS annual meeting.

為了這個目的。讓我們討論一下 BRIUMVI，也就是最近的 REMS 年會上提出的一些數據。

As I alluded to earlier, we presented two important data sets during the meeting. The first was the long term follow up data from our open label extension study from the ultimate one and two phase three trials, which as a reminder for the core trials that supported the approval of riom for individuals with relapsing forms of MS after five years of re retreatment, 92% of patients were free from disability progression. And in the 5th year of treatment, an annualized relapse rate of 0.02 was observed, which is equivalent to one relapse occurring every 50 years of treatment.

正如我之前提到的，我們在會議上展示了兩組重要的數據。第一個是來自最終一期和二期三期試驗的開放標籤擴展研究的長期隨訪數據，作為支持批准 RIOM 用於復發型 MS 患者的核心試驗的提醒，經過五年的重新治療，92% 的患者沒有出現殘疾進展。在治療的第5年，年復發率為0.02，相當於每50年治療就會復發一次。

And importantly, the overall safety profile remained consistent over five years of continuous free on the treatment with no new safety signals emerging with prolonged usage.

重要的是，在五年的持續治療中，整體安全性保持一致，長期使用後沒有出現新的安全訊號。

As we've stated previously, we believe we have set the standard for convenience and IV CD 20 therapy, and we continue to look for ways to further streamline the patient experience at ERMS. We updated data previously presented a in April from our enhanced study showing that individuals with the lapsing forms of MS who are B cell depleted on their current anti CD 20 therapy and were switched to Brim V were able to tolerate the one-hour Brim infusion without first receiving the four-hour introductory dose.

正如我們之前所說，我們相信我們已經為便利性和 IV CD 20 治療設定了標準，並且我們將繼續尋找進一步簡化 ERMS 患者體驗的方法。我們更新了 4 月增強研究中提供的先前數據，該數據表明，患有復發性多發性硬化症 (MS) 且在目前接受抗 CD 20 治療時 B 細胞耗竭的患者在改用 Brim V 後能夠耐受一小時的 Brim 輸注，而無需先接受四小時的入門劑量。

Currently, all IV used to treat MS require two infusions in the first two weeks to initiate therapy.

目前，所有用於治療 MS 的靜脈注射都需要在開始治療的前兩週進行兩次輸液。

This approach would only require one visit to start additionally electrons. We presented data for the first time on a faster 30-minute rev infusion from our enhanced trial data presented while still preliminary. So that the first maintenance dose of given as a 30-minute infusion as opposed to one hour was well tolerated with all infusion related reactions being mild grade one and resolved completely.

這種方法只需要一次訪問即可啟動額外的電子。我們首次從初步階段提出的增強試驗數據中展示了有關更快的 30 分鐘轉速輸注的數據。因此，首次維持劑量以 30 分鐘輸注而不是 1 小時輸注的方式給藥，耐受性良好，所有輸注相關反應均為輕度一級，並可完全緩解。

We have now treated over 50 individuals with RMS with 30minute Rey and look forward to presenting updated data at a future medical conference.

我們現在已經使用 30 分鐘 Rey 治療了超過 50 名 RMS 患者，並期待在未來的醫學會議上展示更新的數據。

As you can imagine, more testing including randomized trials will be needed to incorporate these potential updates into our label. But hopefully this highlights our longer-term vision to continually seek to improve the patient journey with bribe and maintain what we believe is a best-in-class profile.

您可以想像，需要進行更多測試（包括隨機試驗）才能將這些潛在更新納入我們的標籤中。但希望這能凸顯我們的長期願景，即不斷尋求透過賄賂改善病患旅程，並保持我們認為一流的形象。

And further to achieving that goal, I'd like to remind everyone that we are also developing a version of Brown V.

為了實現這一目標，我想提醒大家，我們還在開發 Brown V 版本。

While the majority of individuals with MS choose IV CD 20 delivered every six months, which is how Ryam is currently offered. And we expect that to continue the at home self-administered subsidy market is meaningful accordingly. We believe that offering an at home self, a self-administered subcu brim would open up a new market opportunity for us.

而大多數 MS 患者則選擇每六個月注射一次 CD 20，這也是 Ryam 目前提供的方式。因此，我們預期繼續發展家庭自營補貼市場具有重大意義。我們相信，提供一個在家就能自行管理的皮下注射裝置，為我們開闢新的市場機會。

We expect to be able to provide an update from our privi subcu bioequivalent study by early next year. And if all goes well, we'd be targeting a pivotal trial commencing in the middle of 2025.

我們期望能夠在明年初提供我們的 privi subcu 生物等效性研究的最新消息。如果一切順利，我們將計劃在 2025 年中期開始一項關鍵試驗。

And finally, beyond BRIUMVI on the R&D front, we previously shared that the US FDA has cleared our investigational new drug application IND for Azure cell and off the shelf allogeneic CD 19 car T cell therapy for the treatment of autoimmune diseases.

最後，除了研發方面的 BRIUMVI，我們之前分享過，美國 FDA 已批准我們用於治療自體免疫疾病的 Azure 細胞和現成的同種異體 CD 19 CAR T 細胞療法的新藥研究申請 IND。

The team has been working hard to move this forward and we are targeting, launching a phase one study around the end of this year or early next year, starting in individuals with progressive MS. There is an exciting new opportunity that we believe may offer a new treatment for individuals with progressive MS who have few options, switching gears a little bit. I want to highlight a recent transaction related to manufacturing and supply. As you may be aware from our public filings, we currently manufacture Briony at Samsung Biologics in South Korea who are recognized as the global leaders in biologics manufacturing and who have been and continue to be a great partner to TG.

團隊一直在努力推動這一進程，我們的目標是在今年年底或明年年初啟動第一階段的研究，首先從患有進行性 MS 的患者開始。我們相信這是一個令人興奮的新機會，它能為那些沒有太多選擇的漸進性 MS 患者提供一種新的治療方法，只需稍微改變一下方式。我想強調最近與製造和供應相關的交易。您可能從我們的公開文件中了解到，我們目前在韓國三星生物製劑公司生產 Briony，該公司被公認為生物製劑製造領域的全球領導者，並且一直是 TG 的重要合作夥伴。

As Brie continues to grow, as we continue to believe the Blockbuster potential of from a risk management standpoint, we felt it was time to engage a secondary manufacturer of accordingly. We are happy to announce we have secured Fuji film biotechnologies as a second manufacturer, Brioni at the facility based here in the United States.

隨著 Brie 的不斷發展，我們繼續從風險管理的角度相信 Blockbuster 的潛力，我們覺得是時候與之合作的二級製造商了。我們很高興地宣布，我們已確定富士膠片生物技術公司為第二家製造商，Brioni 位於美國的工廠。

As we continue to expand our commercialization efforts in MS and think about the future of privi.

隨著我們繼續擴大在 MS 的商業化努力並思考 privi 的未來。

We believe this is an important next step that will continue to support our growth plans and provide additional security for our drug supply.

我們相信這是下一步的重要舉措，它將繼續支持我們的成長計劃並為我們的藥品供應提供額外的保障。

In closing, I want to thank all of our TG for their hard work and commitment to people living with MS.

最後，我要感謝我們所有的 TG 為 MS 患者所做的努力和承諾。

Our progress is a testament to our collective efforts and I'm excited about the path forward through your efforts. TG is poised to become a new leader in the MS market focused on developing and delivering innovative therapies for multiple sclerosis.

我們的進步證明了我們共同的努力，我對透過你們的努力所取得的進步感到興奮。TG 預計將成為 MS 市場的新領導者，專注於開發和提供多發性硬化症的創新療法。

With that. I'll hand the call over Adam Waldman, our Chief Commercialization Officer to walk you through our commercial performance in more detail. Thank you, Adam. Go ahead.

就這樣。我將把電話交給我們的首席商業化官亞當·沃爾德曼 (Adam Waldman)，讓他更詳細地向您介紹我們的商業表現。謝謝你，亞當。前進。

Yeah, thank you, Mike. I'm excited to share the continued commercial success with experience with and the steps we're taking to drive future long-term growth since its launch, BRIUMVI has consistently exceeded our expectations with Q3 marking another strong quarter of sequential revenue growth.

是的，謝謝你，麥克。我很高興與大家分享我們持續的商業成功經驗以及自推出以來我們為推動未來長期增長而採取的措施，BRIUMVI 一直超出我們的預期，第三季度又一個季度實現了強勁的連續收入增長。

As Mike mentioned, we achieved second quarter net sales of $83.3 million reflecting approximately 15% quarter over quarter growth and over 230% growth from the same quarter last year, solidifying Briony is the fastest growing DMT in the US MS market.

正如 Mike 所提到的，我們第二季的淨銷售額達到 8,330 萬美元，環比成長約 15%，比去年同期成長超過 230%，鞏固了 Briony 作為美國 MS 市場成長最快的 DMT 的地位。

And while we did observe some expected summer dynamics in the third quarter where new patient visits tend to slow, particularly during July and August enrollments into our hub rebounded in September. And that momentum continued until October where we saw a record enrollment month.

雖然我們確實觀察到第三季度出現了一些預期的夏季動態，即新患者就診量趨於放緩，尤其是在 7 月和 8 月，但 9 月份我們中心的就診量有所反彈。這種勢頭一直持續到十月份，我們的入學人數創下了歷史新高。

We continue to see steady growth in new prescribers and treatment centers. Now reaching nearly 1,100 prescribers across approximately 600 centers including 95% of the TOP100 MS centers since launch.

我們繼續看到新開處方人員和治療中心的數量穩步增長。自推出以來，現已涵蓋約 600 個中心的近 1,100 名處方人員，其中包括 95% 的 TOP100 MS 中心。

Encouragingly, two thirds of the new prescribers in Q3 came from the hospital setting, which is now our fastest growing segment and accounts for approximately 55% of our overall business.

令人鼓舞的是，第三季三分之二的新處方來自醫院，醫院是目前我們成長最快的領域，約占我們整體業務的 55%。

We continue to believe in BRIUMVI best in class profile, including its high level of advocacy, well established safety profile and a one-hour infusion every six months attributes which we believe strongly resonate with health care providers looking for a convenient yet highly effective treatment option.

我們繼續相信 BRIUMVI 具有一流的品質，包括其高度的宣傳性、完善的安全性和每六個月一小時的輸液特性，我們相信這些特性會與尋求便捷而又高效治療方案的醫療保健提供者產生強烈共鳴。

We were particularly excited to see the overwhelming positive response to BRIUMVI at the Act conference in September. As Mike mentioned, BRIUMVI was featured prominently in the clinical data we presented garnered strong interest from health care providers and thought leaders in the M community. Several key takeaways emerged from the conference from a commercial perspective.

我們特別高興地看到，在 9 月的 Act 會議上，BRIUMVI 獲得了壓倒性的積極回應。正如 Mike 所說，BRIUMVI 在我們展示的臨床數據中佔據突出地位，引起了 M 社區醫療保健提供者和思想領袖的濃厚興趣。從商業角度來看，這次會議得出了幾個關鍵結論。

First, we believe the enhanced trial which showed the potential for BRIUMVI to have a rapid 30-minute infusion could represent a significant enhancement to our profile.

首先，我們相信，增強型試驗顯示 BRIUMVI 具有 30 分鐘快速輸注的潛力，這可能對我們的產品線產生重大影響。

Second, the enhanced trial showed the potential to switch from a CD 20 to BRIUMVI without requiring a loading dose. We believe this will make switching potentially easier for many patients who may not be satisfied with their current CD 20 therapy.

其次，增強試驗表明，無需負荷劑量即可從 CD 20 轉換為 BRIUMVI。我們相信，對於許多對目前的 CD 20 療法不滿意的患者來說，這將使轉換療法變得更容易。

And finally, the open label extension presentation underscored Bri's long-term efficacy and safety reinforcing its potential best in class profile. The data demonstrated an impressive, annualized relapse rate of just 0.02% at five years equivalent to one relapse for 50 patient years along with consistent five-year safety data.

最後，開放標籤擴展演示強調了 Bri 的長期有效性和安全性，增強了其潛在的同類最佳性能。數據顯示，五年內年復發率僅 0.02%，相當於 50 名患者年復發一次，且五年安全性數據一致。

We believe this information reinforces brims value proposition and will particularly resonate with physicians and patients who seek established long term data. Before adopting new therapies, the visibility and recognition we received at X has certainly strengthened our confidence in its long term positioning as the preferred anti CD 20 therapy in relapsing forms of MS.

我們相信這些資訊強化了邊緣價值主張，並將特別引起尋求建立長期數據的醫生和患者的共鳴。在採用新療法之前，我們在 X 獲得的知名度和認可無疑增強了我們對其作為複發性 MS 首選抗 CD 20 療法的長期定位的信心。

Another contributing factor to Bri's growing success is the expansion of our commercial infrastructure.

Bri 日益成功的另一個因素是我們商業基礎設施的擴張。

Excuse me. Over the last two years, we have nearly doubled our commercial field team ensuring that we can adequately support the rising demand for BMV and increase our reach within key MS treatment centers. This expansion has allowed us to increase our presence across the US market. As a result, we've been able to engage and educate more physicians on the BMV product profile.

打擾一下。在過去的兩年中，我們的商業現場團隊規模幾乎擴大了一倍，以確保我們能夠充分支持不斷增長的 BMV 需求，並擴大我們在主要 MS 治療中心的影響力。此次擴張使我們在美國市場的市佔率得以擴大。因此，我們能夠吸引更多的醫生並讓他們了解 BMV 產品概況。

Alongside the commercial team expansion. We have also started to increase our investments in patient awareness. Recognizing that informed patients are often key drivers in treatment decisions. We have launched targeted awareness campaigns aimed at educating patients on the benefits of brandy.

隨著商業團隊的擴大。我們也開始加大對患者意識的投資。認識到知情的患者通常是治療決策的關鍵驅動因素。我們發起了有針對性的宣傳活動，旨在讓患者了解白蘭地的好處。

These campaigns are aimed at aimed at empowering patients to have informed discussions with their health care providers.

這些活動的目的是為了讓患者能夠與他們的醫療保健提供者進行知情的討論。

We believe that by raising awareness directly among patients, we can further accelerate adoption and ensure that more individuals living with relapsing forms of MS can benefit from Mbas unique profile. Our patient centric strategy will remain a focal point as we continue expanding our outreach efforts in 2024 and we plan to significantly increase investment in these activities in 2025 and beyond what since launch, we've made significant strides in assurance in ensuring BRIUMVI's availability and access. As I mentioned previously, this has always been a prioritized area for us, and we are pleased that we maintain 95% coverage with national and regional payers.

我們相信，透過直接提高患者的認識，我們可以進一步加快採用速度，並確保更多患有復發型 MS 的個人可以從 Mbas 的獨特功能中受益。隨著我們在 2024 年繼續擴大外展工作，我們以患者為中心的策略仍將是我們關注的焦點，我們計劃在 2025 年大幅增加對這些活動的投資，自推出以來，我們在確保 BRIUMVI 的可用性和可訪問性方面取得了重大進展。正如我之前提到的，這一直是我們優先考慮的領域，我們很高興能夠保持 95% 的國家和地區付款人覆蓋率。

Additionally, our team is doing an exceptional job facilitating the reimbursement process and working with customers and patients to make sure patients can access BRIUMVI.

此外，我們的團隊在促進報銷流程和與客戶和患者合作以確保患者能夠使用 BRIUMVI 方面做得非常出色。

We have worked diligently to streamline the patient journey ensuring that BRIUMVI is accessible with minimal delay, which has helped sustain our patient inherence and satisfaction. Our time to infusion continues to decrease and our persistent and our persistence at week 24 continues to exceed our expectations.

我們一直努力簡化患者的就診流程，確保能夠以最少的延遲獲得 BRIUMVI，這有助於維持患者的忠誠度和滿意度。我們的輸液時間持續減少，並且我們的持久性和第 24 週的持久性繼續超出我們的預期。

Our performance this quarter reinforces our belief that Bri's profile continues to resonate in the market and our commercial organization is very capable of continuing to to deliver results as we look to Q4 and beyond, we expect to see continued growth and accordingly. We are raising our full year guidance for beyond the net us sales to $300 to $305 million.

本季的表現強化了我們的信念，即 Bri 的形象將繼續在市場上引起共鳴，我們的商業組織完全有能力繼續取得成果，展望第四季度及以後，我們預計將繼續成長。我們將全年美國以外地區淨銷售額預期上調至 3 億至 3.05 億美元。

We continue to exceed our expectations and have raised this number substantially from our original full year guidance of $220 to $260 million provided in early 2024.

我們繼續超越我們的預期，並將這一數字從我們最初全年預期的 2.2 億美元大幅提高到 2024 年初提供的 2.6 億美元。

We continue to be excited about what lies ahead. Our foundation is strong. We're poised to capture more growth in the coming quarters and we are, we believe we are well positioned to grow Brioni into a Blockbuster brand.

我們繼續對未來充滿興奮。我們的基礎十分牢固。我們準備在未來幾季實現更多成長，我們相信我們已經準備好將 Brioni 發展成為 Blockbuster 品牌。

In conclusion, I want to thank our team for their dedication and hard work. Their outstanding efforts are contributing to the positive experience with BRII and confidence in our organization. I also want to thank the health care providers and their patients for their trust in TG therapeutics together, we will continue to improve outcomes for those in need. We certainly have more work to do but we're focused and extremely motivated, continue to work every day to bring the B to those living with MS and their families with that. I'll turn the call over to Sean Power Our co.

最後，我要感謝我們團隊的奉獻和辛勤工作。他們出色的努力為 BRII 帶來了積極的體驗，並增強了我們組織的信心。我還要感謝醫療保健提供者和他們的患者對 TG 療法的信任，我們將繼續為有需要的人改善治療結果。我們當然還有更多工作要做，但我們會集中精力、積極性極高，繼續每天努力為 MS 患者及其家人帶來 B。我會將電話轉給我們公司的 Sean Power。

Thank you, Adam and thanks, again to everyone for joining us earlier this morning. We reported our detailed third quarter 2024 financial results which can be viewed on the investors and media section of our website this morning. I'll start by highlighting our Q3 revenue as Adam detailed earlier, we are pleased to report third quarter MV, net product revenue of $83.3 million for the three-month period, bringing our year-to-date nine-month BMV net product revenue to $206.4 million.

謝謝你，亞當，也再次感謝大家今天早上加入我們。我們報告了 2024 年第三季的詳細財務業績，您可以在今天早上我們網站的投資者和媒體部分查看。我首先要重點介紹我們的第三季收入，正如亞當之前詳細介紹的那樣，我們很高興地報告第三季的 MV，三個月期間的淨產品收入為 8330 萬美元，使我們今年迄今為止的九個月的 BMV 淨產品收入達到 2.064 億美元。

Turning now to our income statement for the period. We are pleased to report that we generated net income in both the three- and nine-month, nine-month periods ending September 2024 for the three months ended September 30th, 2024. Our GAAP net income was approximately $3.9 million or 2¢ per diluted share when excluding non-cash items. Net income for the three-month period was approximately $15.7 million.

現在來看看我們本期的損益表。我們很高興地報告，在截至 2024 年 9 月 30 日的三個月內，我們在截至 2024 年 9 月的三個月和九個月期間均創造了淨收入。不包括非現金項目，我們的 GAAP 淨收入約為 390 萬美元或每股稀釋收益 2 美分。三個月期間的淨收入約為1570萬美元。

Our OpEx during the quarter, excluding noncash items came in at the low end of our guided range at approximately $50 million.

本季度，我們的營運支出（不包括非現金項目）處於我們指導範圍的低端，約為 5,000 萬美元。

Our OpEx for the first nine months of 2024 is approximately $155 million.

我們 2024 年前九個月的營運支出約為 1.55 億美元。

And for the full year, we expect our OpEx to come in well below the guidance of approximately $250 million.

我們預計全年營運支出將遠低於約 2.5 億美元的指導價。

And finally, I'll close by touching briefly on our cash position.

最後，我將簡要地談談我們的現金狀況。

We ended the third quarter with approximately $341 million in cash, cash equivalents and investment securities, which we believe provides us with a strong financial position to support the brim V commercialization, our research and development efforts and our continued business operations for the foreseeable future.

截止第三季度，我們擁有約 3.41 億美元的現金、現金等價物和投資證券，我們相信這為我們提供了強大的財務狀況，以支持 Brim V 的商業化、我們的研發工作以及可預見的未來持續的業務運營。

On a related note, I'd like to briefly touch on our share repurchase program which we commenced during the third quarter.

與此相關，我想簡單談談我們在第三季開始實施的股票回購計畫。

We began slowly buying shares back during the third quarter and we will continue with a measured approach for the foreseeable future.

我們從第三季開始緩慢回購股票，並且在可預見的未來我們將繼續採取審慎的做法。

Although the share amounts, we purchased during the third quarter were minimal. We do expect this program to continue throughout the remainder of the year and into 2025.

儘管我們在第三季購買的股票數量很少。我們確實預計該計劃將持續到今年剩餘時間和 2025 年。

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

說完這些，我現在將把電話轉回給會議接線員，開始問答環節。

Thank you and I'll be conducting a question and answer session if you'd like to be placed into the question. Q please press star one on your telephone keypad. We ask you, please ask one question. One follow up, then return to the queue once again, that's star one to be placed into question Q and please ask one question and one follow up. Then return to the queue for participants using speaker equipment may be necessary to take yourself off speaker phone before pressing star one.

謝謝您，如果您願意回答這個問題，我將進行問答環節。Q 請按電話鍵盤上的星號鍵。我們請您問一個問題。一個後續問題，然後再次返回佇列，將星號一放入問題 Q，然後請提出一個問題和一個後續問題。然後返回佇列，對於使用揚聲器設備的參與者，可能需要在按下星號鍵之前關閉揚聲器電話。

Our first question today is coming from Edward White from H.C. Wainwright & Co. Your line is now live.

今天的第一個問題來自 H.C. 的 Edward White。 Wainwright & Co. 您的線路現已通電。

Good morning. Thanks for taking my questions. First, I wanted to ask a big picture question. You mentioned in the press release that you expect to see continued growth in 2025. I just wanted to get your thoughts on the size of the anti-CD 20 market in MS in 2025 and your thoughts on market share, not only for BriamD but also IV versus sub-Q.

早安.感謝您回答我的問題。首先，我想問一個大問題。您在新聞稿中提到，預計 2025 年將持續成長。我只是想了解一下您對 2025 年 MS 中抗 CD 20 市場規模的看法，以及對市場份額的看法，不僅是對於 BriamD，還包括 IV 與 sub-Q。

Thanks, Edward, for the question, Adam, you want to take a crack at that one.

謝謝，愛德華，亞當，你這個問題，你想嘗試嗎？

Sure, good morning. Sure. For so big picture. I mean, we see CD 20s continuing to grow.

當然，早安。當然。為了這麼大的圖景。我的意思是，我們看到 CD 20 持續成長。

You know, it's in the low 50% of dynamic shared today. We see no reason that that can't continue to grow to mid 50 s to even 60%.

您知道，目前它的動態共享率還不到 50%。我們認為沒有理由不能繼續成長至 50% 左右甚至 60%。

You know, I think that the momentum continues behind the class. You know, as far as our market share growth. I mean, we're, we're about 15% of the you know, CD 20 market today. And then, and you know, we think we have a lot of room to grow.

你知道，我認為班級後面的勢頭會持續下去。您知道，就我們的市場佔有率成長而言。我的意思是，我們目前佔據了 CD 20 市場的 15% 左右。然後，你知道，我們認為我們還有很大的成長空間。

Okay, thanks. And just a question on the announced Fuji Film, secondary us based manufacturing, your gross margins have been pretty consistent this year quarter over quarter. Will this agreement have any impact on gross margin.

好的，謝謝。關於富士軟片宣布的美國二級製造業，今年你們的毛利率與上一季相比保持了相當穩定的狀態。該協議會對毛利率產生影響嗎？

Going forward?

繼續前進？

Sean will talk about that.

肖恩將會談論這個問題。

Thanks for the question in the, in the near term, Absolutely not. And we'll have some up upfront expenditures associated with that, but that will of course run through R&D. And in the, in the long term, we think gross margins would, would remain consistent. So short answer to your question is no, no real impact on gross.

感謝您提出這個問題，從短期來看，絕對不會。我們將會產生一些與此相關的前期支出，但這當然會透過研發支出。從長遠來看，我們認為毛利率將保持一致。所以對你的問題的簡短回答是“不”，對總量沒有實際影響。

Margin.

利潤。

Yeah.

是的。

Yeah.

是的。

And I forgot to answer one part of your question, which was the IV to subcu you know, we, we, we believe it's around 70% IV to subcu in terms and, and we do still believe it is as Mike said in his remarks, the clear patient preference today and, and we see that continue.

我忘了回答你問題的一部分，即靜脈注射到皮下注射，我們認為靜脈注射到皮下注射的比例約為 70%，而且我們仍然相信，正如邁克在他的評論中所說的那樣，當今患者明顯偏好這種注射方式，而且我們看到這種情況仍在繼續。

Great. Thanks Adam and thanks to everyone. Congratulations.

偉大的。謝謝亞當，也謝謝大家。恭喜。

On the quarter.

按季度。

Makes sense.

有道理。

And this question is coming from Michael DiFiore from EVERCORE ISI is now live.

這個問題是來自 EVERCORE ISI 的 Michael DiFiore 提出的，現在正在直播。

Hey guys, thanks so much for taking my question. And congrats on the quarter two for me. Were there any inventory channel dynamics during three Q and separately? What was the TRX script count in three Q? And, and how many new patient scripts have been received in the hub? I noticed that wasn't included in your, in your print this morning. Thank you.

嘿夥計們，非常感謝您回答我的問題。恭喜我第二季取得的成績。在三個季度以及單獨季度中，庫存管道動態是否有所變化？三 Q 中 TRX 腳本數量是多少？而且，中心收到了多少份新的病人處方？我注意到你今天早上的印刷品中沒有包括這一點。謝謝。

Thanks for the question. Adam, you want to tackle those, the inventory and TX.

謝謝你的提問。亞當，你想解決這些問題，庫存和 TX。

Yeah, first question, Michael. There's, there are no change, no, no changes in inventory in the quarter. All distributors are at normal inventory levels.

是的，第一個問題，麥可。本季庫存沒有變動。所有分銷商的庫存水平均正常。

And as far as the the enrollments, you know, we, we're going to move away from providing that number. I think as we continue to grow our hospital business, the our capture rate continues to go down in terms of, you know, because hospitals are just less likely to use our hub. So we, we just don't think that this is going to be a, an accurate measure going forward. I think directionally it, it can help. Certainly, but I think in, in sort of using it as a way to sort of garner whether we're growing or not growing. It's just with the capture rate fluctuating and more and more hospitals coming into play that are, that are certainly just not using it. We've decided to focus more on the revenue guidance as we've done over the past several quarters and we'll continue to do going forward, but we just don't think hub enrollments are, are it was good in the beginning, I think certainly in the beginning when we had a much higher percentage of our business coming from private practices that use the hub much more consistently. It was a good measure as we continue to go out here as, as more, you know, I said in our remarks about 55% of our business that was coming from hospitals. It's the fastest growing of our segment and they're just less likely to use our hub and, and that, that creates some, some difficulty in, in, in interpreting the information out of the hub enrollment data.

至於入學人數，你知道，我們將不再提供該數字。我認為，隨著我們醫院業務的不斷發展，我們的捕獲率會持續下降，因為醫院不太可能使用我們的中心。所以我們只是不認為這會是一個準確的未來衡量標準。我認為從方向上看，它可以提供幫助。當然，但我認為，可以用它來判斷我們是成長還是不成長。只是，捕獲率正在波動，而且越來越多的醫院開始發揮作用，但肯定沒有使用它。我們決定更專注於收入指導，就像我們過去幾季所做的那樣，而且我們將繼續這樣做，但我們只是不認為中心註冊在開始時是好的，我認為當然在開始的時候，我們的業務中有很大一部分來自更持續使用中心的私人診所。這是一個很好的舉措，因為我們會繼續走出去，正如我在評論中所說，我們 55% 的業務來自醫院。這是我們領域中成長最快的部分，但他們不太可能使用我們的中心，這就為解讀中心註冊資料中的資訊帶來了一些困難。

Got it very helpful. Thank you.

非常有幫助。謝謝。

The next question is coming from Eric Joseph from JP Morgan. Your line is now live.

下一個問題來自摩根大通的 Eric Joseph。您的線路現已通電。

Hi, good morning. Just, just picking up on the the, the plan to adapt for a faster infusion time. Just coming out of the the enhance updated XS. Can I get you to elaborate a little bit more on sort of what you, what might be needed to support a label indication for either a shorter infusion or skipping a loading dose for switch patients? You mentioned, you know, possibly needing randomized data. Would the focus there be exclusively on safety? And would you need to assess more than one infusion per patient as part of that as part of a trial like that?

嗨，早安。只是，只是接受了這個計劃，以適應更快的輸液時間。剛推出增強更新的 XS。我能否請您更詳細地說明一下，對於轉換患者，需要哪些條件來支持標籤上的指示，即縮短輸注時間或跳過負荷劑量？您提到過，可能需要隨機資料。那裡的重點會只放在安全上嗎？作為這樣的試驗的一部分，您是否需要對每位患者進行多次輸液評估？

Yeah, thanks for the question, Eric. So the answer to the last part of your question. Will we need more than one infusion? Is probably unclear today, but I, I don't think so. I don't think we'll need more than one infusion per patient to, to tell on the safety and, and yes, it's primarily a safety study. You know, for, for faster infusions historically, when you've been done before with other companies and they do require randomized trials and they usually are looking at safety and tolerability. I think that's what we're, our expectations are.

是的，謝謝你的提問，艾瑞克。這就是你問題最後一部分的答案。我們是否需要多次輸液？今天可能還不清楚，但我不這麼認為。我認為我們不需要對每個患者進行超過一次輸液來判斷其安全性，是的，這主要是一項安全性研究。您知道，從歷史上看，對於更快的輸液，當您之前與其他公司合作時，他們確實需要隨機試驗，通常會考慮安全性和耐受性。我想這就是我們的期望。

Okay, great. And maybe a follow up if I could with respect to the subcu initiative, can you talk a little bit about sort of what you are tracking in addition to safety to kind of verify or, or sort of assess how long of a dosing interval you could ultimately move forward with a pivotal study.

好的，太好了。如果可以的話，我可以就 subcu 計劃進行跟進，您能否除了談論安全性之外，還談論您正在跟踪什麼，以驗證或評估您最終可以通過關鍵研究推進多長的給藥間隔。

Yeah, so again, with the, with sub two, we're looking at primarily the, the bioequivalent. So again, it's just the amount of material required to match the PK. And yes, that will determine the tolerability of the materials you have to put too much in. You would at some point start to see a deterioration in tolerability at the injection site. But the primary focus is, you know, the B availability that will tell you how much material you need to load into the into the injection. That will ultimately, as you mentioned impact how tolerable it is. So it's all of those pieces will come together at some point soon. We're hoping like I said, to be able to share that data early next year, but those are basically three pieces that have to come together.

是的，所以再說一次，對於第二部分，我們主要關注的是生物等效性。所以再說一遍，這只是匹配 PK 所需的材料數量。是的，這將決定您放入過多材料的耐受性。在某個時候，你會開始看到注射部位的耐受性下降。但主要的關注點是 B 的可用性，它將告訴您需要在註射中裝入多少材料。正如您所說，這最終將影響其可容忍程度。所以所有這些部分很快就會在某個時刻整合在一起。正如我所說的，我們希望能夠在明年初分享這些數據，但基本上需要將這三個部分結合在一起。

Is there APD component? Are you looking at a sort of a B cell decline?

有APD元件嗎？您是否正在觀察 B 細胞衰退的情況？

Yeah, I I could, I could share with you that you saw decline is not an issue in any real dose level.

是的，我可以，我可以告訴你，你看到的下降在任何實際劑量水平上都不是問題。

Okay.

好的。

Thanks for taking the questions.

感謝您回答這些問題。

No, thank you.

不，謝謝。

The next question is coming from Tara Bancroft from TD Cowen. Is that right?

下一個問題來自 TD Cowen 的 Tara Bancroft。是嗎？

Hi, good morning. Thanks for taking the questions. So thinking about your guidance, it assumes just over or I guess just under 20% sequential growth and that's, that's incrementally higher than, than, you know, the 15% from Q3. But I was wondering, looking ahead now, should we assume steady growth like this from here on out or a similar cadence of growth like in, in 2025 like you saw this year and last year with a heavy Q2 and, and, and seasonal impacts. Just, just a bit on how you would vision near near term dynamics here would be really helpful. Thanks.

嗨，早安。感謝您回答這些問題。因此，考慮到您的指導，它假設連續成長率略高於或略低於 20％，而這比第三季的 15％ 略高。但我想知道，展望未來，我們是否應該假設從現在開始會出現這樣的穩定增長，或者像 2025 年那樣出現類似的增長節奏，就像今年和去年看到的那樣，第二季度和季節性的影響很大。只是，稍微談談您對近期動態的展望，這將非常有幫助。謝謝。

Sure, thanks. Adam, you want to talk about one?

當然，謝謝。亞當，你想討論一下嗎？

Sure. Yeah, thanks for the question, Tara. I mean, you know, we, we, we try to provide the best information we have when, when we have it, I think the guidance is strong and, and show sequential revenue growth. We're continuing to do some things here and, and make some investments. And as I mentioned in my remarks around, you know, patient awareness and, and other things that, you know, we we are hoping will continue to fuel the trajectory of the growth of this product. As I mentioned, we think we're poised to make this a Blockbuster brand. And that trajectory, I think there are seasonal.

當然。是的，謝謝你的提問，塔拉。我的意思是，你知道，我們，我們，我們試圖提供我們所擁有的最佳信息，當我們擁有它時，我認為指導是強有力的，並且顯示出連續的收入增長。我們將繼續在這裡做一些事情並進行一些投資。正如我在評論中提到的那樣，我們希望患者意識和其他因素能夠繼續推動產品的成長軌跡。正如我所提到的，我們認為我們已準備好將其打造為百視達品牌。我認為該軌跡具有季節性。

If you look at the MS market in general, there are some quarterly season dynamics that that are in place. You know, as I mentioned in Q3, there were, there were some in, in just the summer months. You know, that can affect the exact line, but I, but I think we are poised to grow more. We're doing things in the market that are, that are getting traction and, and we're, we're very excited about what the future is for brandy.

如果你大致上看 MS 市場，你會發現存在一些季度季節動態。你知道，正如我在第三季度提到的，僅在夏季就有一些。你知道，這可能會影響確切的路線，但我認為我們準備好實現更大的成長。我們在市場上所做的事情正在獲得關注，我們對白蘭地的未來感到非常興奮。

Okay, great. Thanks. And just a quick follow up on, on the previous question about sub Q. You know, I understand you, you mentioned a lot of expectations there, which was helpful, but can you tell us what volume and, and perhaps dosing interval that you're ideally targeting with, with the subcu formulation?

好的，太好了。謝謝。我只是想快速跟進一下之前關於 sub Q 的問題。

Sure. Yeah. So I mean, ideally it would be as less frequently as possible. I think sort of a minimum bar, would be certainly, every other month I think is the minimum bar that we're targeting. And anything less frequent than that, I think would be fantastic. And it would be obviously working towards that, of course. But, you know, no promises. But, yeah, that, that's the minimum profile I think would be every other month is the target for that.

當然。是的。所以我的意思是，理想情況下，它發生的頻率應該越少越好。我認為最低標準肯定是每隔一個月，我認為這是我們所針對的最低標準。如果頻率低於這個數字，我認為就太棒了。當然，我們顯然會朝著這個方向努力。但你知道，沒有任何承諾。但是，是的，我認為那是最低限度的要求，每隔一個月就是這個目標。

Great. Thanks so much.

偉大的。非常感謝。

You got it.

你明白了。

Your next question today is coming from Matthew Kaplan from Ladenburg Thalmann & Co. and your line is now live.

今天的下一個問題來自 Ladenburg Thalmann & Co. 的 Matthew Kaplan，您的線上提問現已直播。

Hey, good morning.

嘿，早安。

Guys and congrats on the quarterly results. I guess for Adam, can you expand on the rates of persistence you're seeing and how it compares to other therapies in the space?

大家好，恭喜你們取得的季度業績。我想對於亞當來說，您能否詳細說明您所看到的持久率以及它與該領域的其他療法相比如何？

Yeah. Hi, Matt. Thanks for the question. You know, we, we you know, the, the only compliance numbers that we have or that we've seen that are published are with the other IB CD 20 competitor. And we're doing, you know, so that, that's been sort of our, our benchmark. And you know what we were expecting and, and we continue, it looks like and again, you know, we're continuing to collect data, but it looks like we're, we're doing at least as good if not better on the week 24 compliance than, than what's out there and published.

是的。你好，馬特。謝謝你的提問。您知道，我們，您知道，我們所擁有的或所看到的已發布的唯一合規數字是與其他 IB CD 20 競爭對手的合規數字。我們正在這樣做，你知道，這就是我們的基準。您知道我們的預期是什麼，而且我們還會繼續收集數據，但看起來，我們在第 24 週的合規性方面做得至少與已經公佈的數據一樣好，甚至更好。

Okay, great. And just to follow up on the enhanced data and the questions with respect to when you could see that incorporated into clinical practice. When, when do you think you could complete the studies necessary to have that available and, and, and update the label?

好的，太好了。只是為了跟進增強的數據和何時可以將其納入臨床實踐的問題。您認為何時才能完成必要的研究，並提供該標籤並更新？

Yeah, thanks Matt. So the goal would be to get those studies started sometime next year, the studies, you know, again, with enrollment into a randomized trial of reasonable size, let's say give or take 200 to 300 subjects. It's going to take at least a year or so. We got a year of enrollment. Follow up should be short. So we should be able to follow the patients and get that data put together pretty quickly and get a filing. And so I think we're even in the best case scenario, it's probably a 2 to 3 year process to get it into the label.

是的，謝謝馬特。因此，我們的目標是在明年某個時候開始這些研究，再次強調，這些研究將招募合理規模的隨機試驗，比如說大約 200 到 300 名受試者。這至少需要一年左右的時間。我們有一年的入學時間。後續行動應該簡短。所以我們應該能夠追蹤患者並很快匯總數據並進行歸檔。所以我認為，即使在最好的情況下，也可能需要 2 到 3 年的時間才能將其貼入標籤。

All right, thanks. Bye.

好的，謝謝。再見。

You got it.

你明白了。

Thank you. Next question. Today is coming from my Mayank Mamtani from B. Riley Securities. Your line is now live.

謝謝。下一個問題。今天，我邀請了 B. Riley Securities 的 Mayank Mamtani 來演講。您的線路現已通電。

Good morning to you. Congrats on a strong quarter and thanks for taking a question. So on, the revenue split, if you are able to share between maintenance and maybe new degree on the patients. And, and if, if you are able to confirm, you know, at what juncture, you know, the maintenance patients overwhelmingly take, take care with the, the new two BMD patients. And, and did you comment by any chance on the share for new two CD 20 versus newly diagnosed, I MS patients. And, and would love to hear any, any color you're seeing in the marketplace on within the intra city 20 class switches you know what percent patients set up for grabs. We'd, we'd love to hear any perspective on that.

早安.恭喜您本季業績表現強勁，感謝您的提問。因此，收入分配方面，如果你能夠在維護費用和患者可能的新學位之間進行分配。並且，如果您能夠確認，在什麼時候，維持治療患者絕大多數需要接受治療，照顧新的兩名 BMD 患者。並且，您是否對新的兩個 CD 20 與新診斷的 I MS 患者的份額做出評論。並且，我很想聽聽您在市場上看到的任何顏色，在市內 20 類交換機中，您知道患者設定了多少百分比的爭奪。我們很樂意聽到對此的任何看法。

Sure, thanks ma'am. Adam Mona, can you crack?

當然，謝謝女士。亞當莫納，你能破解嗎？

Yeah. Yeah. As far as the first question, the revenue split is still mostly new versus repeat, but we do expect in the next several quarters that that will turn upside down, right? Repeat prescriptions will start to be the lion's share of the, of the infusions going, you know, in the next couple of quarters as we continue to stack the stacking effect, and we continue to get patients coming back for week 48 and so on and so forth. So, but today it's still news that majority, but in the next several quarters, we do expect repeat to increase and become the dominant amount of from a revenue split perspective.

是的。是的。就第一個問題而言，收入分成仍然主要是新的而不是重複的，但我們預計在接下來的幾個季度裡這種情況會發生顛倒，對嗎？你知道，在接下來的幾個季度裡，隨著我們繼續疊加效應，重複處方將開始成為輸液的最大份額，我們將繼續讓患者在第 48 週回來等等。因此，但今天這仍然是大多數的新聞，但在接下來的幾個季度中，我們確實預計重複會增加，並從收入分成的角度成為主導。

The I think the second question was share of CD newly diagnosed. Is that, is that right? Mayak?

我認為第二個問題是新診斷的 CD 的比例。是嗎，是嗎？瑪雅克？

Yes. Yes, that's, that's accurate.

是的。是的，非常準確。

Yeah. Yeah. We haven't provided shares in, in newly diagnosed or, you know, new to CD 20. We haven't provided those shares and then your, you know, your third question was about, you know, switching. And we do see, you know, we, we continue to see a sizeable portion of our, of our brandy business coming from switches from both Revi and Kinta. And that has remained pretty steady and consistent since launch.

是的。是的。我們還沒有為新診斷的患者或新 CD 20 患者提供股份。我們還沒有提供這些股份，然後你的第三個問題是關於轉換。我們確實看到，我們白蘭地業務的很大一部分繼續來自 Revi 和 Kinta 的轉換。自推出以來，這項數據一直保持相當穩定且一致。

They asked that because one of our recent surveys indicated, you know, up to 20% of those patients might be up for grabs. So hence the question and, and then lastly on the biologics manufacturing expansion implication, are you able to comment on any long term supply goals that that you may have in mind between the Korea and us facilities in any way to quantify that would be, would be very helpful, Mike. Thanks again for taking the question.

他們之所以問這個問題，是因為我們最近的一項調查顯示，其中多達 20% 的患者可能會被搶走。所以問題是，最後關於生物製劑生產擴張的影響，您能否評論一下您可能想到的韓國和美國工廠之間的長期供應目標，以任何方式量化這一點，會非常有幫助，邁克。再次感謝您回答這個問題。

Yeah, so I don't think we have a good answer for you on that at this moment on my end. But obviously we're, we're securing what we think is what is required for a long term supply between both of Samsung and, and Dyson V.

是的，所以我認為目前我們無法給你一個好的答案。但顯然，我們正在確保三星和戴森 V 之間長期供應所需的一切。

Understood. Thank.

明白了。感謝。

You.

你。

Thank you. Next question is coming from Cory Johnson from Goldman Sachs. Your line is now live.

謝謝。下一個問題來自高盛的科里約翰遜。您的線路現已通電。

Good morning guys. Maybe a couple from us. You talked about the bulk of growth in your, you know, patient patients coming from the hospital setting, I guess, remind us what portion of MS patients are taking care of there and, and why do you think that's been such a good source of new patient growth for you? And then my second question is if you think about 2025 could we see study or even maybe accelerating new patient growth on an absolute basis into year three as you get kind of like, well into the launch here?

大家早安。也許是我們中的一對。您談到了患者數量增長的大部分來自醫院，我想，請讓我們想起有多少比例的多發性硬化症患者在那裡接受治療，以及您為什麼認為這對您來說是一個新患者增長的良好來源？然後我的第二個問題是，如果您考慮 2025 年，我們是否可以看到研究甚至可能在第三年看到絕對基礎上的新患者增長加速，因為您已經進入了這裡的發布階段？

Sure. I'll start with the second question. Yeah, I mean, certainly we do believe that we can have accelerating new patient starts as we get into 2025. We've always felt that, just generally speaking, you know, the more patients that go on, more patients will go on beyond. So there's definitely sort of a inflection point that comes with that when we have enough people on it and have the critical mass. So we think that's part of it, as Adam mentioned is preparing in March, we are taking steps to push as hard as we can to get to that inflection point, whatever whenever and how many patients that may be. We've expanded the size of our commercial team, we're expanding our our marketing efforts coming into 2025. So, yeah, I mean, is it possible, I can't promise it, I mean, I don't think the 15 to 20% quarter over quarter of steady growth that we've had thus far is, is, is, is problematic. I think it's pretty darn good and, and we will continue to bring us to a Blockbuster within a short amount of time. But yes, I think it is also possible that the growth rate could accelerate as we get into 2025. I want to talk with the one about the hospital setting and the percentage of business six months from hospitals.

當然。我先問第二個問題。是的，我的意思是，我們確實相信，到 2025 年，我們可以加速接收新患者。我們一直認為，一般來說，住院的病人越多，繼續住院的病人就越多。所以當我們擁有足夠多的人並達到臨界質量時，肯定會出現某種轉折點。因此，我們認為這是其中的一部分，正如亞當在三月所提到的準備工作，我們正在採取措施，盡最大努力達到那個轉折點，無論何時，無論有多少患者。我們擴大了商業團隊的規模，並將在 2025 年加強行銷。所以，是的，我的意思是，這可能嗎？我認為它非常好，我們將在短時間內繼續將其帶入百視達。不過是的，我認為進入 2025 年時成長率也可能會加速。我想和大家談談醫院環境以及六個月內醫院業務的百分比。

Yeah. So, Corinne it's, it's probably 60 to 65% of patients are being seen in the hospital setting. That's why we're, we we think having continued expansion into that hospital segment is encouraging. And it is now the fastest growing segment that as I mentioned in my prepared remarks. And it is where the the majority of the patients in the US today are being treated.

是的。因此，科琳，大概有 60% 到 65% 的患者是在醫院就診的。這就是為什麼我們認為繼續擴展到醫院領域是令人鼓舞的。正如我在準備好的發言中提到的，它是目前成長最快的領域。目前，美國大多數病人都在這裡接受治療。

Helpful. Thank you guys.

很有幫助。謝謝你們。

Okay, thank you. Next question. Today is coming from Prakhar Agrawal from Cantor Fitzgerald. Is that right?

好的，謝謝。下一個問題。今天，嘉賓是 Cantor Fitzgerald 的 Prakhar Agrawal。是嗎？

Hi, good morning. And thank you for taking my questions and congrats on the quarter. Maybe firstly, now that subcu has launched, what are you seeing on the ground in terms of where it's gaining more share from even qualitatively? And the second question, you'll start generating obviously a lot of cash over the next few years, maybe on the broader capital allocation priorities. Is there any plans to expand the share buyback program or any any other mechanisms you can explore on the capital allocation front?

嗨，早安。感謝您回答我的問題，並祝賀本季取得的成績。首先，既然 subcu 已經推出，您在實際應用中看到了什麼，就其在哪些方面獲得了更多的份額，甚至在品質方面？第二個問題是，未來幾年你顯然會開始產生大量現金，也許是在更廣泛的資本配置優先事項上。有沒有擴大股票回購計畫的計畫或是在資本配置方面您可以探索的其他機制？

Sure, thanks Parker. I want talk about what we've seen in competitive dynamics in the market recently.

當然，謝謝帕克。我想談談我們最近看到的市場競爭動態。

Sure.

當然。

Yeah. So Prakhar, thanks for the question. You know, we've seen no impact from Okin Novo to date.

是的。Prakhar，謝謝你的提問。您知道，到目前為止我們還沒有看到 Okin Novo 的影響。

You know, we, we had, as I mentioned the prepared remarks we had the best month of enrollments ever in October. So, no impact as, as far as we can tell right now.

你知道，正如我在準備好的發言中提到的，十月是我們入學人數最多的一個月。所以據我們目前所知，沒有影響。

And in terms of allocation of cash. Yeah, I mean, well, Sean did mention we've been, we started off, conservatively with the Share Buyback program. It is something that we're, we're committed to continuing on an ongoing basis. So, yeah, we do believe we'll be allocating over time, more cash to share buybacks. But in addition, you know, as Adam again, in his prepared remarks, and I said, alluded to in a prior answer, you know, we're, we're committed to expanding the use .So obviously, we're going to be allocating cash toward continuing to, to build and grow our team, continuing to build and grow our marketing efforts, which, you know, as, as everyone has followed us closely knows, we, we start out with a pretty modest marketing budget when we launch in 23. And I think by the time we get to 25 we'll have a pretty healthy marketing budget. So again, I think we're, we're leaning into the opportunity. We see Briam V as a, as a Blockbuster brand and, and we're going to make sure we try to get there as quickly as we can. So we will be using cash and investing in, in those activities.

以及現金分配方面。是的，我的意思是，肖恩確實提到過，我們已經開始謹慎地實施股票回購計畫。這是我們致力於持續進行的事情。所以，是的，我們確實相信，隨著時間的推移，我們將撥出更多現金用於股票回購。但此外，正如亞當在他的準備好的發言中再次提到的，我之前也說過，我們致力於擴大使用.所以顯然，我們將分配現金用於繼續建立和發展我們的團隊，繼續建立和發展我們的行銷工作，正如每個密切關注我們的人都知道的那樣，當我們在 23 年推出時，我們一開始的營銷預算相當適中。我認為，到 25 歲時，我們將擁有相當健康的行銷預算。因此，我再次認為，我們正在抓住這個機會。我們將 Briam V 視為一個百視達品牌，我們將確保盡快實現這一目標。因此我們將使用現金並投資於這些活動。

And as part of that, again, we'll be investing in these clinical programs that you heard about earlier, right? So we're going to be running more likely than not several randomized trials commencing in 2025 for, you know, faster infusions, skipping the doses, cream one on the front end. And, and of course, sub two, which is obviously the, the highest of the priorities of, of that grouping. So we're going to make investments in those as well. So that's where some of the excess cash goes. Obviously, as you mentioned, Azure sales moving forward and we're excited about the potential there. And then lastly, you know, our, our eyes are, are peeled and, and our business development program is active and if we see something that we think really augments and complements what we're doing, we're going to, we're going to make investments there as well. So I think we've got plenty of potential uses for the excess cash. Although we're, we're not dogmatic about how it gets spent, except I'd say on the front end with the investment in making sure BRIUMVI gets as quickly as possible to that Blockbuster level.

作為其中的一部分，我們將再次投資您之前聽說過的這些臨床項目，對嗎？因此，我們很可能會在 2025 年開始進行幾項隨機試驗，以加快輸液速度、跳過劑量並在前端使用乳霜。當然，第二個子項顯然是該分組中優先順序最高的。因此我們也將對這些領域進行投資。部分多餘現金就流向了這裡。顯然，正如您所說，Azure 的銷售正在向前發展，我們對其潛力感到非常興奮。最後，你知道，我們的眼光是敏銳的，我們的業務發展計劃是積極的，如果我們發現某些東西真的可以增強和補充我們正在做的事情，我們也會在那裡進行投資。所以我認為我們有很多潛在用途來利用這些多餘的現金。雖然我們對如何使用這筆錢並不教條，但我想說的是，在前端的投資要確保 BRIUMVI 盡快達到 Blockbuster 的水平。

Thank you. Next question is coming from Roger Song from Jefferies. Your line is now live.

謝謝。下一個問題來自 Jefferies 的 Roger Song。您的線路現已通電。

Great. Congrats for the quarter and thank you for taking my question. Most of my questions relate to Brown has been on and then maybe just a follow up on the capital allocation for those additional pipeline. So one is in terms of the brain, the expanding to MS indication when you start the trial later this year. And then would you be able to give us provide some proof of concept data to support the plan? Number one, number two is in terms of the allogenics and cell therapy.

偉大的。恭喜本季取得的成績，感謝您回答我的問題。我的大部分問題都與布朗有關，然後也許只是對這些額外管道的資本分配的跟進。因此，一個方面是從大腦角度而言的，當您在今年稍後開始試驗時，將擴展到 MS 指徵。然後您能否向我們提供一些概念證明數據來支持該計劃？第一、第二是關於同種異體治療和細胞療法。

Do you expect to give us some data update next year? And then what will be the, what will be the principle to share the data in terms of the number of patients and then the maturity of the data? Thank you.

您是否預計明年向我們提供一些數據更新？那麼，就病患數量和資料成熟度而言，資料共享的原則是什麼？謝謝。

Yeah, thanks Roger. So I'll start second since it's the first question and I'll work backwards. So the aer cell question yeah, I mean, look, we're, we're hopeful to get that study started later this year. So we've got two months left to, to put our first patient in. If not, it'll be early next year.

是的，謝謝羅傑。由於這是第一個問題，所以我將從第二個問題開始，然後我將倒著做。所以關於空氣細胞的問題是，是的，我的意思是，看，我們希望在今年晚些時候開始這項研究。所以我們還有兩個月的時間來接收我們的第一位病人。如果沒有的話，那就要等到明年年初了。

The cadence of of data coming out of that trial I think is, is yet to be determined. You know, let's hopefully get some patients on as quickly as we can. It's, you know, the logistics of these trials and the ability to put patients on rapidly is, is not the same as as working with other biologics. So, but if we can get, you know, a decent number of patients on as quickly as we can hopefully we can get some data out sometime next year, but I wouldn't anticipate, you know, any available data until the second half and more likely than not second half of the year. But again, it's hard to really tell how fast we can enroll.

我認為該次試驗得出的數據節奏尚未確定。你知道，我們希望能夠盡快接收一些病人。您知道，這些試驗的後勤工作以及快速讓患者接受治療的能力與其他生物製劑不同。所以，如果我們能盡快獲得相當數量的患者，我們希望能在明年某個時候獲得一些數據，但我預計要到下半年才會有任何可用數據，而且更有可能是下半年。但同樣，我們很難真正知道招生速度有多快。

Although again, historically, these studies have been enrolled slowly. So, let's, let's keep a hopeful eye on that because I do think it has a lot of promise in, in the areas in which we intend to study particularly progressive MS and some other areas that we have slated to, to look into. So, TBD on that one, Roger, we'll keep you posted. And in terms of the on the outside MS plans, you know, I could say, you know, from the beginning of the year, we, we did note that that was probably the, the lowest of our, of our near-term interest and priorities. I think we are working toward getting some patients on non-MS indications before the end of this year still. And we can report on that.

儘管從歷史上看，這些研究的進行速度一直很慢。所以，讓我們對此保持樂觀，因為我確實認為它在我們打算研究的領域，特別是進行性 MS 以及我們計劃研究的其他一些領域，有著很大的前景。所以，羅傑，這個問題還有待解決，我們會及時向你通報。就微軟的外部計劃而言，我可以說，從今年年初開始，我們確實注意到，這可能是我們近期興趣和優先事項中最低的。我認為我們仍在努力在今年年底之前讓一些患者獲得非 MS 適應症。我們可以對此進行報道。

If and when it happens, I think part of the challenge in our, in our plants outside of MS right now are really, you know, evaluating all the options. I mean, there's been so much new CD 20 B cell data that's come out across multiple disease areas that we've been really taking our time. And I know we've said this before but with the new information, gives us more options to, to look at and to decide. And it's also, you know, the thought of whether it's an IV opportunity or potentially subcu opportunity as you move into some of these other indications.

如果這種情況發生，我認為我們目前在密蘇裡州以外的工廠面臨的挑戰實際上是評估所有的選擇。我的意思是，已經有這麼多新的 CD 20 B 細胞數據出現在多個疾病領域，我們確實花了不少時間。我知道我們之前說過這個，但有了新的訊息，我們就有了更多的選擇，可以去查看和決定。而且，您知道，當您轉向其他一些適應症時，也要考慮它是否是靜脈注射機會或潛在的皮下注射機會。

So, I don't I don't have any specifics to discuss today, but it is definitely on the radar screen. The team is working on, on putting non MS patients into trials this year. And the, the commercial team certainly is helping us to evaluate what the the next best indications are going to be. And I'm assuming 2025 we, we'll talk more about that and we'll get that up and running.

所以，我今天沒有任何具體內容要討論，但它肯定是在關注的範圍內。該團隊今年正在致力於讓非 MS 患者參與試驗。而且，商業團隊肯定會幫助我們評估下一個最佳跡像是什麼。我預計到 2025 年，我們會對此進行更多討論，並使其付諸實施。

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

謝謝。我們的問答環節結束了。我想將發言權轉回給大家，以便大家可以發表進一步的評論或結束語。

Great. Thank you and thanks again everyone for joining us on today's call. We look forward to continuing the positive momentum into the end of the year and into next year. And as discussed today, we'll continue to be focused on several key priorities. First, expanding our brionte launch effort including building out our commercial footprint and increasing our spend in marketing. Next, advancing our brioni expansion initiatives through our subcutaneous development, our enhanced switch study and exploring new indications for BRI MV. And finally commencing our phase one A cell and progressive MS as well as looking at opportunities to expand our pipeline with that I'd like to close by thanking those with MS and their health care providers to put their trust in TG and Brown V and our loyal shareholders for their support. And once again, the whole team at TG for making it all happen. Have a great day.

偉大的。謝謝大家，再次感謝大家參加今天的電話會議。我們期待這種積極勢頭能延續到今年年底和明年。正如今天討論的那樣，我們將繼續關注幾個關鍵優先事項。首先，擴大我們的 brionte 推出力度，包括擴大我們的商業足跡和增加我們的行銷支出。接下來，我們將透過皮下開發、增強開關研究和探索 BRI MV 的新適應症來推進我們的 brioni 擴張計劃。最後，我們開始第一階段 A 細胞和進行性 MS 的治療，並尋找機會擴大我們的產品線，最後，我想感謝 MS 患者及其醫療保健提供者對 TG 和 Brown V 的信任，並感謝我們忠實的股東的支持。再次感謝 TG 整個團隊讓這一切成為可能。祝你有美好的一天。

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

謝謝。其中包括今天的電話會議網路直播。我現在就斷開您的線路，祝您有美好的一天。我們感謝您今天的參與。