TG Therapeutics Inc (TGTX) 2025 Q3 法說會逐字稿

Greetings, and welcome to the TG Therapeutics' third quarter earnings call and webcast. (Operator Instructions) Please note, this conference is being recorded.

大家好，歡迎參加 TG Therapeutics 第三季財報電話會議和網路直播。（操作員說明）請注意，本次會議正在錄音。

I will now turn the conference over to your host, Jenna Bosco, Chief Communications Officer. Please go ahead.

現在我將把會議交給主持人，首席傳播官 Jenna Bosco。請繼續。

Thank you. Welcome, everyone, and thank you for joining us this morning. I'm Jenna Bosco, and with me to discuss TG Therapeutics' third 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. Following our Safe Harbor statement, Mike will begin with an overview of our recent corporate developments. Adam will provide an update on our commercial efforts, and Sean will review our financial results before we open the call for Q&A.

謝謝。歡迎各位，感謝大家今天早上的參與。我是 Jenna Bosco，今天與我一起討論 TG Therapeutics 2025 年第三季度財務業績的有：董事長兼首席執行官 Michael Weiss；首席商務官 Adam Waldman；以及首席財務官 Sean Power。在我們的安全港聲明之後，Mike 將首先概述我們最近的公司發展。Adam 將介紹我們商業方面的最新進展，Sean 將回顧我們的財務業績，之後我們將開放問答環節。

Before we begin, I would like to remind everyone that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may include expectations regarding our future operating and financial performance, including sales trends, revenue guidance, projected milestones, development plans and the outlook for our marketed products.

在開始之前，我想提醒大家，今天的討論將包含1995年《私人證券訴訟改革法案》所界定的前瞻性陳述。這些聲明可能包括對我們未來營運和財務表現的預期，包括銷售趨勢、收入指引、預期里程碑、發展計畫以及我們上市產品的前景。

Please note that these statements are subject to risks and uncertainties that could cause our actual results to differ materially from those indicated. These risks are detailed in our SEC filings. Additionally, any forward-looking statements made today reflect our views only as of this date, and we disclaim any obligation to update or revise them. As a reminder, this conference call is being recorded and will be available for replay for the next 30 days on our website at www.tgtherapeutics.com.

請注意，這些聲明存在風險和不確定性，可能導致我們的實際結果與所示結果有重大差異。這些風險已在我們的美國證券交易委員會文件中詳細說明。此外，今天所做的任何前瞻性陳述僅反映我們截至目前為止的觀點，我們不承擔更新或修改這些陳述的任何義務。再次提醒各位，本次電話會議正在錄音，錄音將在我們網站 www.tgtherapeutics.com 上提供 30 天的回放。

With that, I'll turn the call over to Mike Weiss, our CEO. Mike?

接下來，我將把電話交給我們的執行長麥克·韋斯。麥克風？

Thank you, Jenna, and good morning, everyone. I'm pleased to report that TG delivered another strong quarter. Our flagship product, BRIUMVI for relapsing MS continues to outperform, exemplifying what happens when innovation meets execution. We've always believed BRIUMVI had a best-in-class profile, and we've built what we believe is the best-in-class team around it. That combination, great product, great people tends to work out pretty well in most businesses, and it seems to be working out pretty well for us, too.

謝謝你，珍娜，大家早安。我很高興地報告，TG 迎來了一個強勁的季度業績。我們的旗艦產品 BRIUMVI 用於治療復發型多發性硬化症，其表現持續優異，充分體現了創新與執行相結合所帶來的效果。我們一直認為 BRIUMVI 擁有同類最佳的品質，並且我們圍繞它組建了我們認為同類最佳的團隊。優秀的產品和優秀的人才這種組合在大多數企業中往往都能取得不錯的成效，而且對我們來說似乎也效果很好。

We're equally committed to continuing to innovate to improve outcomes for those living with MS. That's what's driving the two pivotal studies we launched last quarter. The first, ENHANCE, explores in a randomized cohort whether we can consolidate the BRIUMVI day 1 and day 15 doses into a single day 1 infusion while maintaining bioequivalent exposure, making treatment easier for patients and more efficient for centers. The response from sites and patients has been tremendous, so much so that we've already completed enrollment. If all goes as planned, we should have data by the middle of next year and potentially a launch of this new simplified dosing schedule in 2027.

我們同樣致力於不斷創新，以改善多發性硬化症患者的治療效果。這就是我們上個季度啟動的兩項關鍵研究的驅動力。第一項研究 ENHANCE 在隨機隊列中探索我們是否可以將 BRIUMVI 第 1 天和第 15 天的劑量合併為第 1 天的單次輸注，同時保持生物等效的暴露，從而使患者更容易接受治療，並使治療中心更有效率。來自各研究中心和患者的反應非常熱烈，以至於我們已經完成了招募工作。如果一切按計畫進行，我們應該在明年年中就能獲得數據，並有可能在 2027 年推出這種新的簡化給藥方案。

The second is our Phase III subcutaneous ublituximab study, what I'd like to call a true subcu product, short push, auto-injector compatible and designed for self-administration. We're testing two dosing schedules, once every other month and once quarterly. Enrollment is going quite well, and we believe we're on track to finish enrollment in the first half of next year, deliver top line pivotal data in late '26 or early '27 and if positive, setting the stage for potential approval and launch in '28. We view subcutaneous ublituximab as a major opportunity that can nearly double the total addressable market for BRIUMVI. And if approved, it would make TG the only company offering both IV and self-administered CD20 options, we believe providing us with a unique competitive advantage.

第二項是我們的 III 期皮下注射 ublituximab 研究，我稱之為真正的皮下注射產品，注射距離短，兼容自動注射器，專為自我給藥而設計。我們正在測試兩種給藥方案，一種是每兩個月一次，另一種是每季一次。招募工作進展順利，我們相信我們能夠按計劃在明年上半年完成招募工作，在 2026 年末或 2027 年初提供關鍵性數據，如果結果積極，將為 2028 年的潛在批准和上市奠定基礎。我們認為皮下注射ublituximab是一個重大機遇，可以讓BRIUMVI的潛在市場規模幾乎翻倍。如果獲得批准，這將使 TG 成為唯一一家同時提供靜脈注射和自我注射 CD20 方案的公司，我們相信這將為我們帶來獨特的競爭優勢。

Subcu ublituximab may also open up new opportunities for us. For example, we continue to explore the potential of BRIUMVI in MG and have treated a small number of patients with encouraging results. Beyond BRIUMVI, we're developing azer-cel, our allogeneic CAR T therapy for individuals with progressive MS. It's still early, but for people living with progressive MS, this type of therapy could be life-changing. Looking across our pipeline, I can envision the possibility of meaningful new launches in '27, '28 and '29, each with the potential to drive continued growth into the next decade.

皮下注射ublituximab也可能為我們開闢新的機會。例如，我們繼續探索 BRIUMVI 在 MG 中的潛力，並已對少量患者進行了治療，結果令人鼓舞。除了 BRIUMVI 之外，我們還在開發 azer-cel，這是一種用於治療進行性多發性硬化症患者的同種異體 CAR T 療法。現在下結論還為時過早，但對於患有進行性多發性硬化症的人來說，這種療法可能會改變他們的生活。縱觀我們的產品線，我預見到在 2027 年、2028 年和 2029 年可能會推出意義重大的新產品，每一款產品都有可能推動公司在未來十年持續成長。

While we innovate, we also remain financially disciplined. We've seen a lot of deals in the market lately. Some look tempting, but we've chosen to stay patient and true to our principles. And when we can't deploy capital better inside the business, we return it to shareholders. During the quarter, we completed our initial $100 million share repurchase program, buying back 3.5 million shares at an average price of about $28.50.

在不斷創新的同時，我們也保持著財務上的自律。最近市場上出現了許多交易。有些誘惑看起來很誘人，但我們選擇保持耐心，堅守我們的原則。當我們無法在企業內部更好地利用資金時，我們會將資金回饋給股東。本季度，我們完成了最初的 1 億美元股票回購計劃，以平均每股約 28.50 美元的價格回購了 350 萬股股票。

The Board has now authorized another $100 million program, giving us flexibility to keep doing what makes sense. Operationally, we continue to be profitable and growing and expect that trend to continue, barring any onetime business development moves that might change the picture temporarily, but strengthen it in the long term. In closing, Q3 was another quarter of strong execution and meaningful progress. We're delivering on our commercial goals, advancing our development programs and maintaining financial discipline, all while keeping patients at the center of everything we do.

董事會現已批准另一項 1 億美元的計劃，使我們能夠靈活地繼續進行合理的事情。從營運角度來看，我們持續獲利並不斷成長，預計這一趨勢將持續下去，除非出現任何可能暫時改變現狀但從長遠來看會加強現狀的一次性業務發展舉措。總而言之，第三季依然是執行力強勁、進展顯著的季度。我們正在實現商業目標，推進研發項目，並保持財務紀律，同時始終將患者放在我們一切工作的中心。

Now I'll hand the call over to Adam Waldman, our Chief Commercial Officer, to provide a detailed BRIUMVI launch update. Adam, go ahead.

現在我將把電話交給我們的商務長亞當·沃爾德曼，讓他詳細介紹 BRIUMVI 的發射情況。亞當，你繼續。

Thank you, Mike, and good morning, everyone. I'm excited to share our third quarter commercial performance. As Mike mentioned, TG continues to execute exceptionally well across both our clinical and commercial fronts. And that progress is clearly reflected in another strong quarter for BRIUMVI. US net sales for BRIUMVI in Q3 totaled approximately $153 million, extending our track record of strong sequential and year over year growth. BRIUMVI’s performance once again exceeded both our internal targets and the Street's expectation, underscoring the depth and consistency of demand we continue to see across the marketplace. We continue to see favorable dynamics across key commercial indicators.

謝謝你，麥克，大家早安。我很高興與大家分享我們第三季的商業業績。正如麥克所提到的，TG 在臨床和商業方面都繼續表現出色。這一進展在 BRIUMVI 又一個強勁的季度業績中得到了充分體現。BRIUMVI 第三季在美國的淨銷售額約為 1.53 億美元，延續了我們強勁的環比和同比增長記錄。BRIUMVI 的業績再次超越了我們內部的目標和華爾街的預期，凸顯了我們在整個市場中持續看到的強勁且穩定的需求。我們持續看到各項關鍵商業指標呈現正向態勢。

Demand remains strong, supported by sustained physician engagement and increasing patient awareness. Persistence and repeat prescribing both exceeded expectations, reinforcing our confidence in BRIUMVI’s clinical profile and the positive real-world experiences being reported by physicians and patients.

在醫生持續參與和患者意識不斷提高的推動下，市場需求仍然強勁。持續用藥和重複處方均超出預期，增強了我們對 BRIUMVI 臨床表現以及醫生和患者所報告的積極真實世界體驗的信心。

We also continue to add new prescribers and accounts, broadening our base across academic centers and community neurology practices. We believe the anti-CD20 class will continue to expand as more physicians and patients choose the efficacy, safety and convenience of this treatment approach. The CD20 class now represents nearly $10 billion in annual US. MS sales and yet approximately half of all patients remain on other types of disease-modifying therapies, underscoring the significant opportunity that still exists for CD20s and BRIUMVI. The BRIUMVI value proposition is stronger than ever, a convenient twice yearly 1-hour infusion backed by six years of data showing consistent efficacy, durable safety and proven real-world performance.

我們也不斷增加新的處方醫生和客戶，擴大我們在學術中心和社區神經科診所的客戶基礎。我們相信，隨著越來越多的醫生和患者選擇這種治療方法的有效性、安全性和便利性，抗 CD20 藥物類別將繼續擴大。CD20階級目前在美國的年產值接近100億美元。儘管 MS 銷售額有所增長，但仍有大約一半的患者繼續接受其他類型的疾病修飾療法，這凸顯了 CD20 和 BRIUMVI 仍然存在的巨大機會。BRIUMVI 的價值主張比以往任何時候都更加強大，它只需每年兩次、每次 1 小時的便捷輸注，並有六年的數據支持，證明其具有持續的療效、持久的安全性和經證實的真實世界性能。

At the 2025 ACTRIMS Conference, data further validated BRIUMVI's long-term benefits and captured significant attention across the MS community. Results from the open-label extension of the ULTIMATE I and II trials showed that after six years of continuous treatment, nearly 90% of patients remain free from disability progression with an annualized relapse rate in the sixth year of treatment of just 0.012, equivalent to one relapse every 83 years of patient treatment.

在 2025 年 ACTRIMS 大會上，數據進一步證實了 BRIUMVI 的長期益處，並引起了 MS 界的廣泛關注。ULTIMATE I 和 II 試驗的開放標籤擴展結果顯示，經過六年的持續治療，近 90% 的患者病情未惡化，第六年的年復發率僅為 0.012，相當於每 83 年患者治療僅復發一次。

The safety profile remains stable with no new safety signals identified, reaffirming BRIUMVI's long-term tolerability and consistency. Complementing these clinical findings, there was real-world data from the ENABLE observational study, which demonstrated that BRIUMVI's efficacy and infusion tolerability are translating into meaningful measurable outcomes for people living with MS in everyday practice. Together, these data strengthen BRIUMVI's differentiated position as a therapy that we believe combines best-in-class efficacy, a proven safety record and unmatched infusion convenience.

安全性概況保持穩定，未發現新的安全訊號，再次證實了 BRIUMVI 的長期耐受性和一致性。除了這些臨床發現之外，ENABLE 觀察性研究的真實世界數據也表明，BRIUMVI 的療效和輸注耐受性正在轉化為 MS 患者在日常實踐中有意義的可衡量結果。這些數據共同鞏固了 BRIUMVI 作為一種療法的獨特地位，我們相信它結合了同類最佳的療效、可靠的安全記錄和無與倫比的輸注便利性。

This powerful combination continues to resonate with healthcare providers across all settings from large academic centers to community practices and the VA system, where BRIUMVI remains the preferred anti-CD20 therapy. Another key driver of our ongoing success has been the strategic expansion of our commercial field organization.

這種強大的組合持續受到從大型學術中心到社區診所和退伍軍人事務部等各種醫療機構的醫護人員的歡迎，在這些機構中，BRIUMVI 仍然是首選的抗 CD20 療法。我們持續成功的另一個關鍵驅動因素是我們商業現場組織的策略擴張。

As outlined in our launch plan, we have methodically grown the team over the last two years to align with the market opportunity, ensuring the right reach, capabilities and expertise as adoption of BRIUMVI continues to build, while maintaining the discipline and the precision that defines TG's commercial approach. This strategy has proven highly effective, expanding our reach and helping us drive continued growth. We will continue to expand selectively as opportunities arise, maintaining a balanced focus on coverage, productivity and operational efficiency.

正如我們在發布計劃中概述的那樣，在過去的兩年裡，我們有條不紊地壯大了團隊，以適應市場機遇，確保隨著 BRIUMVI 的採用不斷增加，我們擁有合適的覆蓋面、能力和專業知識，同時保持 TG 商業方法所體現的紀律性和精確性。事實證明，這項策略非常有效，擴大了我們的業務範圍，並幫助我們實現了持續成長。我們將繼續根據機會選擇性地進行擴張，同時保持對覆蓋範圍、生產力和營運效率的平衡關注。

We believe our approach have resulted in one of the most capable and experienced commercial teams in the MS industry, a team that executes with professionalism, consistency and a clear commitment to educating both patients and providers. Complementing our strategic growth, Q3 also marked the first full quarter of our national television campaign, supported by expanded digital streaming and social media initiatives.

我們相信，我們的方法造就了 MS 行業中最有能力、最有經驗的商業團隊之一，該團隊以專業精神、一致性和對患者及醫療服務提供者的明確承諾來執行任務。為了配合我們的策略性成長，第三季度也是我們全國電視廣告宣傳活動的第一個完整季度，並得到了擴大的數位串流媒體和社交媒體舉措的支持。

These efforts are designed to work together to drive awareness, engagement and patient activation, hopefully sparking meaningful conversations between patients and their healthcare providers about treatment options. Early indicators that these efforts are working are encouraging. Branded search activity, website traffic and quality website visits and overall brand -- a patient brand awareness are all elevated relative to pre-campaign baselines.

這些努力旨在共同提高公眾意識、參與度和患者積極性，希望能夠引發患者及其醫療保健提供者之間關於治療方案的有意義的對話。初步跡象顯示這些努力正在奏效，令人鼓舞。與活動進行前的基線相比，品牌搜尋活動、網站流量、高品質網站流量以及整體品牌——患者品牌認知度均有所提升。

And as we move into Q4, we plan to grow and optimize this investment to continue to build awareness and support long-term growth. Looking ahead, we remain confident in our trajectory. Based on the strong year-to-date performance, continued new patient growth and positive persistence trends, we are again raising our full year 2025 US BRIUMVI net revenue guidance from $570 million to $575 million to now approximately $585 million for the full year 2025. This updated guidance reflects favorable demand trends and consistent execution by our commercial team.

隨著我們進入第四季度，我們計劃擴大和優化這項投資，以繼續提高知名度並支持長期成長。展望未來，我們對自身的發展軌跡依然充滿信心。基於今年迄今為止的強勁業績、持續的新患者成長和積極的持續趨勢，我們再次將 2025 年全年美國 BRIUMVI 淨收入預期從 5.7 億美元至 5.75 億美元上調至約 5.85 億美元。此次更新後的指導意見反映了良好的市場需求趨勢以及我們銷售團隊的持續執行力。

Looking beyond 2025, we remain highly confident in BRIUMVI’s long-term potential. With a growing prescriber base, expanding patient engagement, a proven commercial infrastructure and continued investment in our product life cycle, we believe BRIUMVI is on track to become a multibillion-dollar brand in RMS.

展望 2025 年後，我們仍對 BRIUMVIâm 的長期潛力充滿信心。憑藉不斷增長的處方醫生群體、不斷擴大的患者參與度、成熟的商業基礎設施以及對產品生命週期的持續投資，我們相信 BRIUMVI 預計將成為 RMS 領域價值數十億美元的品牌。

In summary, Q3 was another strong quarter of execution, consistent performance and continued strategic progress. We're proud of what the team has accomplished this year and look forward to carrying that momentum into year-end and beyond. I want to thank our team for their ongoing dedication and professionalism. Your commitment continues to drive meaningful results for people living with MS and for TG.

總而言之，第三季執行力強勁，業績穩定，策略進展持續。我們為團隊今年的成就感到自豪，並期待將這種勢頭保持到年底及以後。我要感謝我們團隊一直以來的奉獻和專業。您的付出持續為多發性硬化症患者和TG帶來有意義的成果。

With that, I'll turn it over to Sean to walk through the financials.

接下來，我將把發言權交給肖恩，讓他來分析財務狀況。

Thank you, Adam, and good morning, everyone. Earlier this morning, we released our detailed third quarter 2025 financial results via press release, which is available on the Investors and Media section of our website. Let's begin with a closer look at our revenue performance. Our third quarter results reflect sustained commercial strength with total revenue reaching $161.7 million, an increase of 93% compared to Q3 '24 and 15% over Q2 '25. Product revenue totaled $159.3 million, driven primarily by $152.9 million in US BRIUMVI net sales.

謝謝你，亞當，大家早安。今天早些時候，我們透過新聞稿發布了 2025 年第三季的詳細財務業績，該新聞稿可在我們網站的投資者和媒體版塊中找到。讓我們先來仔細看看我們的營收表現。我們第三季的業績反映了持續的商業實力，總收入達到 1.617 億美元，比 2024 年第三季成長 93%，比 2025 年第二季成長 15%。產品收入總計 1.593 億美元，主要得益於美國 BRIUMVI 產品淨銷售額 1.529 億美元。

Turning to expenses. Our total operating expenses, defined as R&D and SG&A, excluding noncash compensation, totaled approximately $86.6 million in the third quarter and approximately $239 million for the nine months ended September 30. While the quarterly figure is up compared to the second quarter of '25, which came in at approximately $71 million, we remain on track to meet our full year OpEx guidance of approximately $300 million to $320 million. The quarter over quarter increase in OpEx was primarily driven by continued investment in R&D for subcutaneous BRIUMVI as well as higher SG&A spend to support the continued expansion of the BRIUMVI commercial footprint.

接下來談談費用。第三季度，我們的總營運支出（定義為研發和銷售、一般及行政費用，不包括非現金補償）總計約為 8,660 萬美元；截至 9 月 30 日的九個月，該支出總計約為 2.39 億美元。雖然本季數字比 2025 年第二季的約 7,100 萬美元有所成長，但我們仍有望實現全年營運支出目標，約 3 億至 3.2 億美元。營運支出較上季成長主要是由於皮下注射 BRIUMVI 的研發持續投入，以及為支援 BRIUMVI 商業版圖的持續擴張而增加的銷售、管理及行政支出。

On the balance sheet side of things, as Mike mentioned, we completed our initial share repurchase program. During the third quarter, we repurchased approximately $78 million of shares at an average price of approximately $28. Following this activity, we ended the third quarter with approximately $178 million in cash, cash equivalents and investment securities. 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. On the bottom line, we are pleased to report GAAP net income of $390.9 million or $2.43 per diluted share for the third quarter of 2025.

在資產負債表方面，正如麥克所提到的，我們已經完成了首次股票回購計畫。第三季度，我們以平均每股約 28 美元的價格回購了約 7,800 萬美元的股票。完成上述活動後，我們在第三季末持有約 1.78 億美元的現金、現金等價物和投資證券。我們相信，雄厚的資本實力使我們能夠繼續執行長期策略，同時保持靈活性，以便未來對我們的產品線和營運進行投資。綜上所述，我們很高興地宣布，2025 年第三季 GAAP 淨收入為 3.909 億美元，即每股攤薄收益 2.43 美元。

This compares to $3.9 million or $0.02 per diluted share in the same period last year. Our third quarter results include a nonrecurring income tax benefit of approximately $365 million, driven by the release of our deferred tax asset valuation allowance. For reference, a valuation allowance is recorded against deferred tax assets when it is more likely than not that those assets will not be realized. Given our track record of profitability, projected operating income and positive outlook, we concluded that a release of the valuation allowance was appropriate as of September 30, 2025. While this release impacts reported GAAP net income and earnings per share, it does not affect our cash position or our day-to-day operating performance.

相比之下，去年同期為 390 萬美元，即每股攤薄收益 0.02 美元。我們第三季的業績包括約 3.65 億美元的非經常性所得稅收益，這是由於我們釋放了遞延所得稅資產估值準備金。作為參考，當遞延所得稅資產極有可能無法實現時，應針對這些資產提列估價準備。鑑於我們以往的獲利記錄、預計的營業收入和積極的前景，我們認為從 2025 年 9 月 30 日起釋放估值準備金是合適的。雖然此次發表會影響報告的 GAAP 淨收入和每股收益，但不會影響我們的現金狀況或日常經營業績。

This represents our sixth consecutive quarter of profitability, driven by BRIUMVI revenue growth and disciplined expense management. In summary, the third quarter was a meaningful step forward for TG. We delivered strong commercial performance, continued to invest in long-term growth opportunities and achieved our sixth consecutive quarter of profitability.

這標誌著我們連續第六個季度實現盈利，這主要得益於 BRIUMVI 的收入成長和嚴格的費用管理。總而言之，第三季對TG來說是意義重大的一步。我們取得了強勁的商業業績，繼續投資於長期成長機會，並實現了連續第六個季度獲利。

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

接下來，我將把通話交給會議接線員，開始問答環節。

(Operator Instructions)

（操作說明）

Tara Bancroft, TD Cowen.

塔拉·班克羅夫特，TD Cowen。

So my question is regarding the guidance. So this updated figure, it implies just a slight slowing of sequential growth in this Q4 versus what we've seen in prior Q4 reports in previous years. So I'm curious to get your thoughts on what kind of headwinds that you're expecting this quarter compared to prior years and maybe also a discussion of which tailwinds from here that can support maybe better-than-expected growth like the DTC efforts, the ENHANCE data, et cetera?

所以我的問題是關於指導意見的。因此，根據更新後的數據，與往年第四季報告相比，本季環比成長速度略有放緩。所以我很想知道，與往年相比，您預計本季會面臨哪些不利因素？另外，能否討論哪些有利因素可以支持成長，使其超出預期，例如 DTC 計劃、ENHANCE 數據等等？

Thanks for the question. Adam, do you want to tackle that one?

謝謝你的提問。亞當，你想處理這個問題嗎？

Sure. A number of factors in Tara. I think the growth that we assumed in Q4 is actually quite good, 14% quarter over quarter in the third year here. I think that's a pretty good growth rate. And the guidance is based on a number of factors. Probably most is patient retention at this point and better-than-expected patient retention that is helping us see demand growth. But as I mentioned, field expansion is also helping us. And hopefully, those media investments will start to see some demand increases as we go forward here, too.

當然。塔拉的許多因素。我認為我們在第四季度預期的成長實際上相當不錯，第三年實現了 14% 的季度環比增長。我認為這是一個相當不錯的成長率。此指導意見是基於多種因素制定的。目前來看，最重要的可能是病患留存率，而高於預期的病患留存率也幫助我們看到了需求成長。但正如我所提到的，領域拓展也對我們有幫助。希望隨著時間的推移，這些媒體投資也能開始看到需求成長。

Brian Cheng, JPMorgan.

Brian Cheng，摩根大通。

Just curious if you're starting to see additional demand coming from the permanent J-code that's in place in April? And then I have a quick follow-up.

我只是好奇，您是否開始看到4月生效的永久性J代碼帶來的額外需求？然後我還有一個簡短的後續問題。

Adam?

亞當？

I think maybe you have the wrong product. We've had a J-code for several years at this point.

我想你可能買錯產品了。我們已經使用 J 代碼好幾年了。

And then when you think about the expansion of your field operation, where is the focus of expansion specifically as we turn into fourth quarter and into next year? And how are you measuring the return here?

那麼，當您考慮擴大現場營運規模時，隨著我們進入第四季度和明年，具體的擴張重點是什麼？那麼，你們是如何衡量這裡的回報的呢？

Adam, you're on a roll, keep going.

亞當，你狀態正佳，繼續加油。

Sorry. So the question was expansion of the field force. Is that what you're getting at?

對不起。所以問題在於場力的擴展。你是這個意思嗎？

Yeah, the expansion of the field force. How are we thinking about the focus here as you think about fourth quarter and into next year? Where is the focus? Where are you expanding specifically?

是的，場力的擴張。展望第四季以及明年，我們目前的重點工作是什麼？重點在哪裡？具體來說，你們計劃在哪些地區擴張？

Sure. Yeah. I mean we're seeing growth across all segments, but we're focused on continuing to drive the hospital business. In Q3, we saw hospital demand growth continue to outpace actually the private practice setting. And the addition of our new sales reps has certainly expanded our reach, and we believe that's having a positive impact on the growth that we're seeing. We continue to add new prescribers and new accounts on a very consistent basis. And so we think all that is having an impact. And we think, as I mentioned in the prepared remarks here, I think that's certainly contributing to the growth that we're seeing.

當然。是的。我的意思是，我們看到所有業務部門都在成長，但我們專注於繼續推動醫院業務的發展。第三季度，我們看到醫院的需求成長持續超過私人診所的需求成長。新銷售代表的加入無疑擴大了我們的業務範圍，我們相信這對我們所看到的成長產生了積極的影響。我們持續不斷增加新的處方醫生和新的帳戶。所以我們認為所有這些都產生了影響。正如我之前在準備好的演講稿中提到的，我認為這無疑有助於我們所看到的成長。

Corinne Johnson, Goldman Sachs.

科琳·約翰遜，高盛集團。

You mentioned in the prepared remarks that the subcutaneous products could double the market opportunity for BRIUMVI and MS. Maybe if you could just provide some color on the factors that are underpinning that estimate.

您在準備好的演講稿中提到，皮下注射產品可能會讓 BRIUMVI 和 MS 的市場機會翻倍。或許您能詳細解釋一下支撐這項估算的因素就好了。

Yeah, I'll lead off. Thanks for the question. I'll lead off, Adam, and you can certainly jump right in. But Corinne, just using some real simple math is how we're getting there. So right now, we think that the subcu portion of the market is about 35% closer to 40% now and growing. So at that level, that would almost double the market opportunity for us again. And if that subcu continues to grow as a percentage of the new starts, so this is -- just to take one step ahead, this is based on dynamic share. So not total share, but dynamic share.

好的，我先來。謝謝你的提問。我先來，亞當，當然也可以馬上加入。但是科琳，我們只需要運用一些非常簡單的數學知識就能得出結論。所以目前，我們認為子帳戶市佔率約為 35% 到 40%，而且還在成長。所以，如果達到那個水平，我們的市場機會幾乎會再次翻倍。如果該子用戶繼續佔新用戶的比例成長，那麼——為了更進一步，這是基於動態份額的。所以不是總份額，而是動態份額。

So on a dynamic share basis, subcu -- self-administered subcu is approximately 35% closer probably to 40% at this point, potentially growing 3 years, 2.5 years or so before we'll be on the market for three years, whatever it is, give or take. So we think there's a chance that it will continue to grow. Obviously, 50% of new starts, that would double the opportunity. So we're somewhere approximately in that range. That's how we're getting to that number. Adam, anything to add on top?

因此，從動態份額來看，子帳戶——自主管理的子帳戶目前約佔 35%，可能接近 40%，並且可能在未來 3 年或 2.5 年左右增長，之後我們將進入市場三年左右，不管怎樣，上下浮動一些。所以我們認為它有可能會繼續成長。顯然，如果新開工率達到 50%，那麼機會就會翻倍。所以，我們大致在這個範圍內。我們就是這樣得出這個數字的。亞當，還有什麼要補充的嗎？

No.

不。

Michael DiFiore, Evercore ISI.

Michael DiFiore，Evercore ISI。

Congrats on the continued progress. A few for me. Any notable inventory channel dynamics to note in 3Q as well as gross to net changes? And also, any color that you care to offer on the competitive dynamics versus the current at-home subcu competitor, which seems to be growing? And I have a follow-up.

恭喜你們持續進步。給我幾個。第三季庫存管道有哪些值得注意的動態變化？毛利與淨利的變化又有哪些？另外，您能否就目前家用子晶片市場的競爭格局，以及該市場似乎正在崛起的競爭對手，提供一些見解？我還有一個後續問題。

Adam, I think those both probably fall directly on you.

亞當，我覺得這兩件事可能都直接歸你負責。

Yeah. Yeah. The first part, Michael, thanks for the question. No inventory changes or gross to net changes in the quarter. Gross to net is still within the range that we've provided.

是的。是的。第一部分，邁克爾，謝謝你的提問。本季庫存無變化，毛利與淨利無變化。總利潤與淨利潤之比仍在我們提供的範圍內。

And then the second question was on subcu. Can you repeat the question on subcu?

第二個問題是關於亞膀胱的。你能再問一次關於亞銅的問題嗎？

Just any color you could offer on the competitive dynamics versus the current at-home subcu competitor, which seems to be growing.

請您就目前家用子母杯競爭對手（似乎正在發展壯大）的競爭動態提供一些看法。

Yeah. As Mike mentioned, the subcu that's in the market today does appear to be growing. They had a good quarter. And that segment of the market is overall has been growing over the last few years, probably faster than the IV market. But it seems to have settled right here, about 65-35 IV to subcu.

是的。正如麥克所提到的，目前市場上的次級晶片似乎確實在成長。他們本季業績不錯。而且，過去幾年裡，該細分市場整體上一直在成長，可能比靜脈注射市場成長得更快。但似乎已經穩定在這裡了，大約是 65-35 IV 到 subcu。

In the future, it's hard to predict how that will change. But certainly, with more subcu products in the market, it's possible you could see continued growth in the subcu section or segment of the market. But today, it looks like things have pretty much settled out in the 65-35, 60-40 IV to subcu. It's not stagnant. It can go up and down a little bit between quarters. But that's generally where it has been and has settled out over the last 12 months -- 12 to 18 months or so.

未來情況會如何變化，很難預測。但可以肯定的是，隨著市場上更多的壓克力產品，亞克力市場或細分市場可能會持續成長。但如今看來，65-35、60-40 IV 到皮下注射的比例似乎基本上已經穩定下來了。它並非停滯不前。節間可能會有小幅波動。但過去 12 個月（大約 12 到 18 個月）以來，情況基本上一直如此，並且趨於穩定。

Very helpful. And my last one is just on BRIUMVI subcu. Any update to when we could possibly see initial PK or exposure data from Phase I?

很有幫助。我最後一個是關於 BRIUMVI 子晶片的。請問何時能看到I期臨床試驗的初步藥物動力學或暴露量數據？

Yeah. So the hope is that we'll be able to get that presented sometime in the first half of next year. Yeah, I think we're targeting first half. I think the team, as you recall, I've been saying for a while, the team has been sort of overwhelmed getting these studies up and running. They haven't really sat down to do the presentation yet, but I think they're now preparing for that. So I think we'll hopefully see something in the first half of next year.

是的。所以我們希望能夠在明年上半年某個時候把它展示出來。是的，我認為我們的目標是上半年。我認為，正如你記得的，我之前也說過，團隊在啟動和運行這些研究方面有點應接不暇。他們還沒有真正坐下來做演示，但我認為他們現在正在為此做準備。所以我認為我們預計在明年上半年看到一些成果。

(Operator Instructions)

（操作說明）

Emily Bodnar, H.C. Wainwright.

艾米莉·博德納，H.C. 溫賴特。

I was wondering if you can walk us through a bit on the ex-US sales of $6.4 million and just general accounting of the Neuraxpharm collaboration?

我想請您詳細介紹一下 640 萬美元的美國以外銷售額以及與 Neuraxpharm 合作的整體會計情況？

Broke up a little bit for me in the middle of that question. But Sean, it sounds like it's -- if you heard it, it's for you.

這個問題問到一半，我有點哽咽了。但是肖恩，聽起來像是——如果你聽到了，那就是給你的。

Yeah, I heard it. Thanks, Emily. So the accounting for ex-US sales has been consistent since we entered into the deal with NXP. When we sell products through to them, that's recorded to product revenue. And then, of course, royalties show up on the license milestone and royalty line.

是的，我聽到了。謝謝你，艾米麗。因此，自從我們與恩智浦達成協議以來，美國以外地區的銷售額的會計處理一直保持一致。當我們透過他們銷售產品時，這筆收入會被計入產品收入。當然，版稅也會出現在授權里程碑和版稅行中。

Prakhar Agrawal, Cantor Fitzgerald.

普拉哈·阿格拉沃爾，坎托·菲茨杰拉德。

Congrats on another strong quarter. So maybe firstly, any initial thoughts on 2026 trends? What could be the positives and negatives that we should be keeping an eye out for?

恭喜又一個季度業績出色。那麼首先，大家對2026年的趨勢有什麼初步想法嗎？我們應該關注哪些正面和負面方面？

And then secondly, I think, Mike, you talked about in the introductory remarks that about deals that look tempting. Can you talk about what were the reasons not to pursue these transactions? Was it the price or something else? And even if you decide to do BD, any details on what stage, therapeutic area or size of the deal would make sense?

其次，我想，麥克，你在開場白中談到了那些看起來很誘人的交易。能談談當初為何沒有進行這些交易嗎？是價格問題還是其他原因？即使您決定進行業務拓展，關於交易的階段、治療領域或規模等細節，您認為哪些是合理的？

Sure. Adam, do you want to tackle the first part in terms of any thoughts on '26, positives or negatives you can envision today?

當然。亞當，關於“26”，你有什麼想法？你現在能想到哪些正面或負面的面向？你想先談談第一部分嗎？

Yeah. I mean the things that we would be looking for, obviously, is continued growth in new patients. As I mentioned, people coming back now represent a larger and increasingly large part of our business. So the rate at which patients continue to come back at weeks 48, 72, 96 and out will be important. As I mentioned, that continues to look very strong right now and continues to drive the growth that we're seeing and better than expected.

是的。我的意思是，我們顯然會關注新患者數量的持續成長。正如我之前提到的，回頭客現在在我們業務中所佔的比例越來越大。因此，患者在第 48 週、第 72 週、第 96 週及以後的複診率將非常重要。正如我之前提到的，目前來看，這一趨勢仍然非常強勁，並繼續推動我們所看到的成長，而且比預期的還要好。

Obviously, we're going to continue to monitor and see how our direct-to-consumer efforts has an effect and impact on overall patient conversions on to treatment and whether that's continuing to work. Like I said in my prepared remarks, the key indicators at this point are very encouraging, but we'll continue to see how that plays out in 2026 as well.

顯然，我們將繼續監測並觀察我們的直接面向消費者的努力對整體患者接受治療的轉換率有何影響，以及這種努力是否繼續有效。正如我在準備好的演講稿中所說，目前的關鍵指標非常令人鼓舞，但我們將繼續觀察2026年的情況如何。

Thanks, Adam. And in terms of deals, look, we've been quite candid in that we've been looking to increase our portfolio, looking for opportunities. I think we've seen every announced deal that you think is within reason of something that we'd be interested in, we've obviously evaluated and looked at extensively. I think for us, we have a high standard for ROI. We have revenue. We're using our money. We're making investments. We've got a pretty high hurdle to get over the hump. It's all about risk reward and potential ROI as we see it and as we calculate it. So I think we've got a lot of good things in the portfolio already.

謝謝你，亞當。至於交易方面，我們一直很坦誠，我們一直在尋求擴大投資組合，尋找機會。我認為，所有你認為我們可能感興趣的、已公佈的交易，我們都進行了廣泛的評估和研究。我認為，我們對投資報酬率的要求很高。我們有收入。我們在用自己的錢。我們正在進行投資。我們要跨越的障礙相當高。在我們看來和計算中，一切都與風險回報和潛在投資回報率有關。所以我覺得我們目前投資組合裡已經有很多不錯的項目了。

Like I said, we're looking to expand, but we're not -- we don't have any desperation to do so, so we have a lot of flexibility to pick and choose what we want to do and how we want to do it and make sure it makes sense. So for us, it's all about ROI and risk reward. And I think the ones that we passed on just didn't meet the threshold as far as we see it. But like I said in the prepared remarks, we continue to look for opportunities. And if we do something, we'll be sure that we believe in it. And in any event, we're always looking to manage our risk versus the reward. It's always a very important concept for us.

正如我所說，我們正在尋求擴張，但我們並不迫切需要這樣做，所以我們有很大的靈活性來選擇我們想做的事情以及我們想怎麼做，並確保這樣做是合理的。所以對我們來說，一切都關乎投資報酬率和風險報酬。我認為我們否決的人，就我們看來，只是沒有達到標準而已。但正如我在準備好的演講稿中所說，我們將繼續尋找機會。如果我們做某件事，我們一定會相信這件事。總之，我們始終都在尋求權衡風險與報酬。這對我們來說始終是一個非常重要的概念。

William Wood, B. Riley Securities.

威廉·伍德，B. Riley 證券公司。

Really nice quarter. Maybe one and one follow-up. I was just curious if you could provide a little bit more clarification on how, when and maybe expectations for fiscal year 2026 guidance on -- maybe not guidance per se, but expectations on where you sort of see the revenues and trying to really understand -- you mentioned that a lot of this was -- a lot of your growth was sort of pegged to maintenance. And maybe if you could just speak to what you're seeing on sort of maintenance drop-offs or switches away from BRIUMVI? And then I have a follow-up.

非常棒的季度。或許一次，再後續一次。我只是好奇您能否就 2026 財年的業績指引（也許不是具體的指引，而是您對收入的預期）提供一些更詳細的說明，並嘗試真正了解——您提到很多增長都與維護有關。或許您可以談談您在維護中斷或從 BRIUMVI 切換出去的過程中看到的情況？然後我還有一個後續問題。

Sure. Thanks. Adam, go ahead.

當然。謝謝。亞當，你繼續。

Sure. Not to -- we're not going to get specific here on 2026 guidance quite yet, but patient persistence remains above expectations. And my comment was that, that's an increasingly bigger and will become an increasingly bigger part of our business going forward. Obviously, we continue to expect new patient growth. We continue to expect market share gains and as we continue to expand our field force and with the DTC efforts that we're having.

當然。不，我們暫時不會具體討論 2026 年的指導方針，但患者的堅持率仍然高於預期。我的評論是，這在我們業務中所佔的比重越來越大，未來還會越來越大。顯然，我們預期新患者數量將持續成長。我們預計市場佔有率將繼續成長，隨著我們不斷擴大銷售團隊以及開展直接面向消費者 (DTC) 的行銷活動，這一目標也將實現。

So both things work together in driving growth over the long term. And I think the DTC investments, as I said, remains to be seen. We're encouraged by what we're seeing so far. We're looking to optimize the investment and really refine our targeting and making sure that we're getting the right message to the right patient. And it's something that we want to continue to lean into. We'll be strategic about it. We'll be thoughtful about it, but we think it can help meaningfully into the future. It remains to be seen. But of course, we think so far, what we're seeing is encouraging.

因此，這兩者共同作用，能夠推動長期成長。正如我所說，我認為 DTC 投資還有待觀察。我們目前所看到的進展令人鼓舞。我們希望優化投資，真正改善目標定位，確保將正確的訊息傳遞給正確的患者。這也是我們希望繼續努力的方向。我們會採取策略性措施。我們會認真考慮，但我們認為它對未來會有很大的幫助。此事尚待觀察。當然，我們認為目前為止我們看到的情況令人鼓舞。

Appreciate it. And then maybe just thinking about the Roche data in SLE from Gazyva this morning. I was curious how much read-through you may -- you sort of see in terms of that going to your BRIUMVI program? And then also if there's anything specifically from the BRIUMVI MG data that shows potential outside of MS in autoimmune?

謝謝。然後，也許只是在思考今天早上羅氏公司發布的 Gazyva 治療 SLE 的數據。我很好奇你閱讀的量有多大——你覺得這和你的 BRIUMVI 計畫有什麼關係？此外，BRIUMVI MG 數據中是否有任何具體資訊表明其在多發性硬化症以外的自體免疫疾病方面具有潛在應用價值？

Yeah. Thanks for that, William. I actually haven't had a chance to review the SLE data very carefully this morning as we're preparing for this call. So I apologize for not being fully briefed on that at the moment. But in terms of MG, yes, I mean, CD20s have applicability across multiple indications. We think MG is one of them. We've certainly seen the CD19 data. We wouldn't expect to see too many differences between CD19 and CD20 in terms of its ability to perform in a certain indication. So we think that MG is interesting. We've treated a handful of patients with some encouraging results.

是的。謝謝你，威廉。今天早上因為要準備這場電話會議，我其實還沒有機會仔細查看 SLE 數據。因此，對於目前我對此事了解不夠全面，我深感抱歉。但就 MG 而言，是的，我的意思是，CD20 適用於多種適應症。我們認為MG就是其中之一。我們當然已經看到了CD19的數據。我們預期 CD19 和 CD20 在特定適應症的療效方面不會有太大差異。所以我們認為MG很有意思。我們已經治療了一些患者，並且取得了一些令人鼓舞的結果。

So I think there's something there. We're still tiptoeing around it for the moment. But if we dive in, we'll certainly let you know. And again, now that's part of our same risk-reward ROI analysis we're doing in terms of how we want to invest our money. So -- but yes, we do think that MG is potentially interesting for us still, and we'll keep everyone posted on that if we do move forward.

所以我認為這裡面一定有蹊蹺。我們目前仍在小心翼翼地迴避這個問題。但如果我們真的要深入研究，一定會通知你們的。再次強調，這也是我們進行風險回報投資報酬率分析的一部分，也是我們決定如何投資資金的一部分。所以——是的，我們仍然認為MG對我們來說可能很有吸引力，如果我們繼續推進，我們會及時向大家通報。

Cha Cha Yang, Jefferies.

Cha Cha Yang，傑富瑞。

This is Cha Cha on for Roger Song. I was hoping that you can give some color on how you expect the simplified dosing regimen for BRIUMVI to expand the market share. Do you have any numbers that you can put on that like you did for the subcutaneous product?

這是 Roger Song 的 Cha Cha 節目。我希望您能詳細說明您認為簡化的 BRIUMVI 給藥方案將如何擴大市場份額。您能否像之前對皮下注射產品一樣，提供一些相關數據？

Yeah. I mean I'll jump in and save Adam from this one. I don't know that there's an easy way to put numbers on top of it. I think this is -- this one doesn't have a clearly different addressable market. So this is within our current addressable market.

是的。我的意思是，我會挺身而出，把亞當從這件事中解救出來。我不知道有沒有簡單的方法可以在上面標註數字。我認為－這款產品並沒有明顯不同的目標市場。所以這屬於我們目前的目標市場範圍。

We do think that it's through market research that we've done that people are attracted to this and interested. And we think the enrollment -- the rapidity of the enrollment is also a clue that people are excited about this potential update to the dosing schedule. But I think it's more challenging to put numbers to it like we're able to do for the subcu, which again is really a separate TAM. Adam, anything you want to add on top of that?

我們認為，正是透過我們所做的市場調查，人們才會被這個產品吸引並產生興趣。我們認為，報名人數——尤其是報名人數的快速增長——也顯示人們對此次劑量方案的潛在更新感到興奮。但我認為，要像對子客戶一樣對它進行量化更具挑戰性，因為子客戶實際上又是一個獨立的TAM（目標市場）。亞當，你還有什麼要補充的嗎？

No, just other than reiterating that there seems to be customer excitement about the simplified regimen, and we've heard this consistently from customers.

不，只是想重申一下，顧客似乎對簡化後的治療方案感到興奮，我們也一直從顧客那裡聽到這樣的回饋。

And this now concludes our question-and-answer session. I would like to turn the floor back over to Mike Weiss for closing comments.

我們的問答環節到此結束。現在我把發言權交還給麥克‧韋斯，讓他做總結發言。

Thank you, and thanks, everyone, again, for joining us today. As we look ahead to the remainder of 2025, our priorities are clear: continue to grow BRIUMVI sales, execute on our subcu and ENHANCE Phase III trials, drive enrollment into our azer-cel program and position TG for long-term leadership in MS and beyond. Our progress to date, I believe, speaks volumes to the value BRIUMVI delivers to patients, healthcare providers and MS centers alike and reflects the dedication of the entire TG team who wake up every day focused on one simple idea, helping those with MS live better lives. I want to thank the entire TG team for their hard work and dedication as well as the HCPs and people living with their MS who continue to place their trust in BRIUMVI and TG.

謝謝大家，再次感謝各位今天蒞臨。展望 2025 年剩餘時間，我們的優先事項很明確：繼續發展 BRIUMVI 的銷售，執行我們的皮下注射和 ENHANCE III 期試驗，推動 azer-cel 項目的招募，並使 TG 在 MS 及其他領域保持長期領導地位。我認為，我們迄今為止的進展充分體現了 BRIUMVI 為患者、醫療保健提供者和 MS 中心帶來的價值，也反映了整個 TG 團隊的奉獻精神，他們每天醒來都專注於一個簡單的想法，那就是幫助 MS 患者過上更好的生活。我要感謝整個 TG 團隊的辛勤工作和奉獻精神，以及繼續信任 BRIUMVI 和 TG 的 HCP 和 MS 患者。

Thanks again for joining us, everyone, and have a great day.

再次感謝各位的參與，祝福大家今天過得愉快。

Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines and have a wonderful day.

女士們、先生們，感謝各位的參與。今天的電話會議到此結束。您可以斷開線路，祝您有美好的一天。