TG Therapeutics Inc (TGTX) 2024 Q2 法說會逐字稿

Greetings. Welcome to TG Therapeutics second-quarter 2024 earnings call. (Operator Instructions) Please note this conference is being recorded. I'll now turn the conference over to Jenna Bosco. Jenna, you may now begin.

問候。歡迎參加 TG Therapeutics 2024 年第二季財報電話會議。（操作員說明）請注意，本次會議正在錄製中。我現在將會議交給珍娜‧博斯科 (Jenna Bosco)。珍娜，你現在可以開始了。

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the second-quarter 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. Adam will share an update on our commercialization efforts, and Sean will give an overview of our financial results before turning the call over to the operator to begin the Q&A session.

謝謝。歡迎大家，感謝您今天早上加入我們。我是 Jenna Bosco，今天與我一起討論 2024 年第二季財務業績的是我們的董事長兼執行長 Michael Weiss； Adam Waldman，我們的首席商業化長；以及我們的財務長 Sean Power。在我們的安全港聲明之後，麥克將概述我們最近的公司發展。Adam 將分享我們商業化工作的最新情況，Sean 將概述我們的財務業績，然後將電話轉交給營運商以開始問答環節。

Before we begin, I'd like to remind everyone that we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected regulatory or clinical 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.

在開始之前，我想提醒大家，我們將根據 1995 年《私人證券訴訟改革法案》的規定做出前瞻性陳述。這些前瞻性陳述包括有關我們預期未來營運和財務表現的陳述，包括銷售業績、預期監管或臨床里程碑、收入指導、開發計劃和對我們上市產品的預期。TG 警告說，這些前瞻性陳述存在風險，可能導致我們的實際結果與所示結果有重大差異。可能影響 TG Therapeutics 營運的因素包括我們向 SEC 提交的文件中可以找到的各種風險因素。此外，本次電話會議中所做的任何前瞻性陳述僅代表我們今天的觀點，不應被視為代表我們以後任何日期的觀點。

We specifically 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.tgtherapeutics.com, where it will be available for the next 30 days. With that, I'd like to turn the call over to Mike Weiss, our CEO.

我們特別聲明不承擔更新或修改任何前瞻性陳述的義務。本次電話會議正在錄製並在 TG 網站 www.tgtherapeutics.com 上進行音訊重播，並將在未來 30 天內提供。說到這裡，我想將電話轉給我們的執行長 Mike Weiss。

Thank you, Jenna, and good morning, everyone, and thank you for joining us for our quarterly earnings call. I'm pleased to report that we had another quarter of outperformance across all aspects of our business, marked by the continued successful launch of our flagship drug BRIUMVI, which was approved about 18 months ago for patients with relapsing forms of multiple sclerosis. The market response has been overwhelmingly positive and our sales performance has exceeded our initial projections. Let me start by highlighting some key achievements for the second quarter of 2024. First, on the commercial front, I'm pleased to share that we achieved $72.6 million in BRIUMVI net sales in the United States, exceeding our target of approximately $65 million, leading us to raise our full year guidance to approximately $290 million to $300 million.

謝謝珍娜，大家早安，謝謝您參加我們的季度財報電話會議。我很高興地向大家報告，我們業務的各個方面又實現了一個季度的優異表現，其標誌是我們的旗艦藥物BRIUMVI 的持續成功上市，該藥物於大約18 個月前被批准用於治療復發型多發性硬化症患者。市場反應非常積極，我們的銷售表現超出了我們最初的預測。首先我要強調 2024 年第二季的一些關鍵成就。首先，在商業方面，我很高興地告訴大家，我們的BRIUMVI 在美國的淨銷售額達到了7260 萬美元，超過了我們約6500 萬美元的目標，這使我們將全年指導提高到約2.9 億至3 億美元。

That's up from $270 million to $290 million from last quarter, which was already raised from our preliminary guidance of $220 million to $260 million provided at the beginning of the year. Our commercial team has done an outstanding job and executing our launch strategy resulting in strong initial adoption. This early success reinforces our confidence in BRIUMVI's long-term potential to reach our goal of becoming the leading treatment for relapsing forms of multiple sclerosis on a dynamic market share basis. On the R&D front, we also had a very productive quarter. While commercialization of BRIUMVI remains our core focus, we continue to explore ways to improve upon the delivery of BRIUMVI, explore potentially new indications for BRIUMVI and advance our newly acquired allogeneic off-the-shelf CD19 CAR-T for autoimmune diseases.

這一數字比上季度的 2.7 億美元增加到 2.9 億美元，這已經比我們年初提供的 2.2 億美元到 2.6 億美元的初步指引有所提高。我們的商業團隊做得非常出色，並執行了我們的發布策略，從而獲得了廣泛的初步採用。這一早期成功增強了我們對 BRIUMVI 長期潛力的信心，以實現我們的目標，即在動態市場份額的基礎上成為複發性多發性硬化症的領先治療藥物。在研發方面，我們也度過了一個非常有成效的季度。雖然BRIUMVI 的商業化仍然是我們的核心重點，但我們將繼續探索改進BRIUMVI 交付的方法，探索BRIUMVI 的潛在新適應症，並推進我們新獲得的同種異體現成CD19 CAR-T 用於自身免疫性疾病。

At the same time, we continue to evaluate opportunities to expand our pipeline. Specifically some R&D highlights for the quarter included our ENHANCE study, which is evaluating ways to streamline the switch to BRIUMVI from other anti-CD20s, continued [into] robust enrollment. We were also able to present preliminary data from the study at the ACTRIMS conference showing that patients can safely be transitioned from other anti-CD20 to BRIUMVI without the [use] for the first dose of 150 milligram over four hours in those patients that enter the study with low B cell counts. We'll look forward to sharing additional data from the ENHANCE trial in the coming months. Another highlight was that we treated our first MS patients with subcutaneous BRIUMVI in a newly launched Phase I study to assess bio-equivalents of subcu versus IV BRIUMVI.

同時，我們繼續評估擴大管道的機會。具體來說，本季的一些研發亮點包括我們的 ENHANCE 研究，該研究正在評估簡化從其他抗 CD20 藥物轉向 BRIUMVI 的方法，並繼續保持強勁的入組率。我們還能夠在 ACTRIMS 會議上提供該研究的初步數據，表明患者可以安全地從其他抗 CD20 過渡到 BRIUMVI，而無需在進入治療階段的患者中在四個小時內[使用]第一劑 150 毫克。 B 細胞計數低的研究。我們期待在未來幾個月分享 ENHANCE 試驗的更多數據。另一個亮點是，我們在一項新啟動的 I 期研究中使用皮下 BRIUMVI 治療了第一批 MS 患者，以評估 subcu 與 IV BRIUMVI 的生物等效性。

This was a high priority for the team and I'm proud of their efforts to get this study initiated quickly. As mentioned in the past, we believe the subcu and IV CD20 markets are distinct and believe this could represent a significant additional opportunity for the BRIUMVI franchise. We believe we will be in a position to share data from this study early next year, and we are still targeting starting a pivotal trial for subcutaneous BRIUMVI by mid-2025. And finally, related to another high priority R&D program, we were excited to report that the US FDA has cleared our investigational new drug application or IND for azer-cel and off-the-shelf allogeneic CD19 CAR-T cell therapy for the treatment of autoimmune diseases.

這是團隊的首要任務，我為他們為快速啟動這項研究所做的努力感到自豪。正如過去所提到的，我們認為 subcu 和 IV CD20 市場是截然不同的，並相信這可能為 BRIUMVI 特許經營權帶來重要的額外機會。我們相信，我們將能夠在明年初分享這項研究的數據，而我們的目標仍然是在 2025 年中期開始皮下 BRIUMVI 的關鍵試驗。最後，與另一個高度優先的研發計劃有關，我們很高興地報告，美國 FDA 已批准我們的 azer-cel 和現成同種異體 CD19 CAR-T 細胞療法的研究性新藥申請或 IND，用於治療自身免疫性疾病。

As a reminder, earlier this year, we entered into a partnership with Precision Biosciences to acquire a worldwide license to azer-cel for indications outside of cancer. With an active IND now in hand, we believe we are on track to launch a Phase I in autoimmune diseases initially in patients with progressive MS by the end of this year. Next, I'd like to highlight our financial position and discuss the share repurchase program we announced this morning. The strong launch of BRIUMVI has positively impacted our financial results, including leading to our first operationally cash flow positive quarter. Sean Power, our CFO, will join shortly to discuss our financial performance in more detail, but I wanted to touch on our newly established 5-year $250 million credit facility with HealthCare Royalty and Blue Owl Capital.

提醒一下，今年早些時候，我們與 Precision Biosciences 建立了合作夥伴關係，以獲得 azer-cel 用於癌症以外適應症的全球許可。有了活躍的 IND，我們相信我們有望在今年年底前針對進展性多發性硬化症患者啟動自體免疫疾病的 I 期臨床試驗。接下來，我想強調我們的財務狀況並討論我們今天早上宣布的股票回購計劃。BRIUMVI 的強勢推出對我們的財務業績產生了積極影響，包括導致我們第一個營運現金流為正的季度。我們的財務長肖恩·鮑爾(Sean Power) 很快就會加入，更詳細地討論我們的財務業績，但我想談談我們與HealthCareRoyalty 和Blue Owl Capital 新建立的5 年期2.5 億美元信貸安排。

The proceeds will first be used to repay, essentially refinance our approximately $170 million of indebtedness and accrued interest owed to Hercules Capital Partners, which was set to mature in tranches from mid-2025 to January of 2026. Another $100 million of proceeds has been allocated to fund up to a $100 million share repurchase plan, which was recently authorized by our Board of Directors. The remainder will simply be added to working capital, providing us with additional operational flexibility. We've been talking about the potential for a share buyback publicly and we're excited to establish this credit facility, which allows us to accelerate our ability to repurchase shares. We see TG as a growth story setting up for possible significant cash flows in the future, and we're committed to sharing that value with our shareholders.

所得款項將首先用於償還，主要是為我們欠Hercules Capital Partners 的約1.7 億美元債務和應計利息進行再融資，這些債務和應計利息原定於2025 年中期至2026 年1 月分批到期。另外 1 億美元的收益已分配用於資助最多 1 億美元的股票回購計劃，該計劃最近獲得了我們董事會的批准。其餘的將簡單地添加到營運資金中，為我們提供額外的營運彈性。我們一直在公開討論股票回購的潛力，我們很高興建立這種信貸安排，這使我們能夠加快回購股票的能力。我們將 TG 視為一個成長故事，為未來可能帶來大量現金流，我們致力於與股東分享這一價值。

This repurchase program is just the first step in that process. Importantly, this new credit facility enables us to repurchase shares without utilizing our current cash, which is dedicated to continuing to build out our commercial infrastructure and footprint, growing our marketing efforts, including growing our direct to patient initiatives and finally investing in our R&D programs. In closing, I want to thank the entire TG team for their dedication and hard work in making this quarter a success. We're excited about the positive impact we're making in patients' lives and the value we're creating for our shareholders. With that, I'll hand the call over to Adam Waldman, our Chief Commercialization Officer, to walk you through our commercial performance in more detail.

此次回購計畫只是過程的第一步。重要的是，這項新的信貸安排使我們能夠在不使用現有現金的情況下回購股票，這些現金致力於繼續建立我們的商業基礎設施和足跡，並加大我們的行銷力度，包括加強我們直接面向患者的舉措，並最終投資於我們的研發項目。最後，我要感謝整個 TG 團隊的奉獻和辛勤工作，使本季取得成功。我們對我們對患者生活產生的積極影響以及我們為股東創造的價值感到興奮。接下來，我會將電話轉交給我們的首席商業化長 Adam Waldman，讓您更詳細地了解我們的商業表現。

Adam, go ahead, please.

亞當，請繼續。

Thank you, Mike, and good morning, everyone. I'm thrilled to share our commercial progress for the second quarter of 2024. Building on the momentum from the first quarter, we have once again delivered strong performance across all key metrics, continuing our commitment to bringing BRIUMVI to patients with relapsing forms of MS. As Mike mentioned, we achieved second quarter net sales of $72.6 million, exceeding our target of $65 million and reflecting approximately 45% growth quarter-over-quarter and 350% growth from the same quarter last year. We saw strong growth in patient enrollments with over 1,400 new patient scripts processed through the TG hub, marking a 12% increase from the previous quarter.

謝謝你，麥克，大家早安。我很高興分享我們 2024 年第二季的商業進展。在第一季的勢頭基礎上，我們再次在所有關鍵指標上取得了強勁的表現，繼續致力於將 BRIUMVI 帶給復發性多發性硬化症患者。正如 Mike 所提到的，我們第二季的淨銷售額達到 7,260 萬美元，超出了 6,500 萬美元的目標，環比成長約 45%，比去年同期成長 350%。我們看到患者註冊人數強勁成長，透過 TG 中心處理了 1,400 多個新患者腳本，比上一季成長了 12%。

We have now had approximately 5,850 new patient prescriptions written to our hub across 525 centers from over 950 prescribers launched to date. We are very pleased with the rate of adoption, but also remember that since not all new prescriptions go to our TG hub, these numbers underestimate the total new patient scripts for BRIUMVI. For the second quarter, we estimate that the hub captured only about 80% to 85% of total new scripts, and as more and more academic centers and independent infusion centers adopt BRIUMVI, this hub capture rate could go down further as these types of centers are less likely to utilize our TG hub services. BRIUMVI continues to gain share in a large and rapidly-growing anti-CD20 market in the RMS. Strong share growth and patient adherence is leading to significant revenue growth for the CD20 class overall year-over-year.

到目前為止，我們已經在 525 個中心向我們的中心開出了約 5,850 張新的患者處方，來自超過 950 名處方者。我們對採用率感到非常滿意，但也請記住，由於並非所有新處方都會進入我們的 TG 中心，因此這些數字低估了 BRIUMVI 的新患者處方總數。對於第二季度，我們估計該中心僅捕獲了新腳本總數的約80% 至85%，並且隨著越來越多的學術中心和獨立輸液中心採用BRIUMVI，該中心捕獲率可能會進一步下降，因為這些類型的中心不太可能使用我們的 TG 中心服務。BRIUMVI 繼續在 RMS 龐大且快速成長的抗 CD20 市場中獲得份額。強勁的市場份額成長和患者的依從性導致 CD20 類別的整體收入同比大幅增長。

The class now represents an approximately $2 billion quarterly revenue opportunity in the US with IV therapies capturing approximately 70% of that. We would expect that the class will continue to grow going forward and BRIUMVI will continue to grow within it. We have seen our prescriber base continue to expand, adding approximately 150 new prescribers and over 70 new accounts in quarter 2. Many of these new prescribers are coming from leading academic centers, further establishing BRIUMVI's presence in the MS treatment landscape.

該類別目前在美國代表約 20 億美元的季度收入機會，其中靜脈注射療法約佔其中的 70%。我們預計該班級將繼續發展，BRIUMVI 將在其中繼續發展。我們看到我們的處方者基礎繼續擴大，第二季增加了約 150 名新處方者和 70 多個新帳戶。這些新處方醫生中有許多來自領先的學術中心，進一步確立了 BRIUMVI 在多發性硬化症治療領域的地位。

Some have also started to come from the VA. As previously announced, we successfully expanded our market reach by securing a contract with the Department of Veteran Affairs making BRIUMVI the preferred anti-CD20 treatment for relapsing forms of MS among veterans. This strategic partnership, which went into effect on June 17th, not only broadens our patient base, but also reinforces BRIUMVI's value proposition. We believe this partnership creates access not only to a new group of patients, but also treating physicians that in many cases have dual appointments at the VA and in academia. Overall, we continue to see strong new patient accumulations, reflecting our effective commercial strategies and operational excellence.

有些也開始來自退伍軍人管理局。正如先前宣布的，我們透過與退伍軍人事務部簽訂合同，成功擴大了我們的市場範圍，使 BRIUMVI 成為退伍軍人中治療復發性多發性硬化症的首選抗 CD20 治療藥物。這項策略性合作關係於 6 月 17 日生效，不僅擴大了我們的病患基礎，也強化了 BRIUMVI 的價值主張。我們相信，這種夥伴關係不僅可以接觸到新的患者群體，還可以接觸到在許多情況下在退伍軍人管理局和學術界擁有雙重預約的治療醫生。總體而言，我們繼續看到強勁的新患者積累，反映了我們有效的商業策略和卓越的營運。

We believe our strategic investments in field force expansion and patient marketing initiatives are yielding high returns, contributing to our overall growth trajectory. Patient access to BRIUMVI remains our top priority. Our comprehensive patient support programs have been instrumental in assisting patients with accessing BRIUMVI and working to ensure they receive the treatment they need. We have received very positive feedback from both patients and healthcare providers about the support and resources available to get patients started on therapy, and our patient adherence at week 24 remains strong. The diversity of patient types being treated with BRIUMVI remains consistent.

我們相信，我們在現場人員擴張和患者行銷計劃方面的策略性投資正在產生高回報，為我們的整體成長軌跡做出貢獻。患者獲得 BRIUMVI 仍然是我們的首要任務。我們全面的患者支援計劃有助於幫助患者獲得 BRIUMVI 並努力確保他們獲得所需的治療。我們從患者和醫療保健提供者那裡收到了關於為患者開始治療提供的支持和資源的非常積極的反饋，並且我們的患者在第 24 週的依從性仍然很強。接受 BRIUMVI 治療的患者類型的多樣性保持一致。

We continue to see a balance mix of patients who are treatment naive, those switching from non-CD20 therapies and those switching from other CD20 therapies. This broad adoption is a testament to BRIUMVI's compelling clinical profile and its differentiation in the marketplace. Looking ahead, we are optimistic about the continued growth and potential of BRIUMVI. Based on current trends in both new patient accumulations and persistence, we are raising our full year guidance, which was $270 million to $290 million to $290 million and $300 million for the year. We expect the quarters to continue to build and have considered the seasonality we saw last year in Q3.

我們繼續看到未接受治療的患者、從非 CD20 療法轉為轉用其他 CD20 療法的患者和轉為其他 CD20 療法的患者的平衡組合。這種廣泛的採用證明了 BRIUMVI 引人注目的臨床特徵及其在市場中的差異化。展望未來，我們對 BRIUMVI 的持續成長和潛力持樂觀態度。根據目前新患者累積和堅持的趨勢，我們將全年指導方針上調，從 2.7 億美元至 2.9 億美元至 2.9 億美元至 3 億美元。我們預計這些季度將繼續成長，並考慮了去年第三季的季節性因素。

We therefore would expect more modest growth from Q2 to Q3 with stronger growth from Q3 to Q4. In conclusion, I want to extend my gratitude to our dedicated team for their relentless efforts in driving the success of BRIUMVI. Their hard work and commitment has been crucial in achieving these remarkable results. I also want to thank the healthcare providers and patients for their trust in TG Therapeutics. Together we're making significant strides in improving outcomes for individuals living with MS.

因此，我們預計第二季至第三季的成長將更為溫和，而第三季至第四季的成長將更為強勁。最後，我要感謝我們的敬業團隊為推動 BRIUMVI 的成功所做的不懈努力。他們的辛勤工作和奉獻精神對於這些卓越成果至關重要。我還要感謝醫療保健提供者和患者對 TG Therapeutics 的信任。我們共同努力，在改善多發性硬化症患者的治療結果方面取得了重大進展。

We're excited about the future and remain focused on our mission to bring BRIUMVI to more patients, helping them live better lives. Thank you. And with that, I'll hand the call over to Sean Power, our CFO. Sean?

我們對未來感到興奮，並繼續專注於我們的使命，將 BRIUMVI 帶給更多患者，幫助他們過上更好的生活。謝謝。接下來，我會將電話轉交給我們的財務長 Sean Power。肖恩？

Thank you, Adam, and thanks, everyone, for joining us. Earlier this morning, we reported our detailed second quarter 2024 financial results, which can be viewed on the Investors and Media section of our website. Before I get into the results for the quarter, I'd like to begin by briefly discussing the accounting matter we described in 8-K filed earlier this morning. During our second quarter review, we identified an error which was deemed to be immaterial related to the expense recognition of a single restricted stock grant from 2021. This error was isolated to 2021 and 2022 and does not impact results of operations in any other or subsequent period.

謝謝你，亞當，也謝謝大家加入我們。今天早些時候，我們報告了 2024 年第二季的詳細財務業績，您可以在我們網站的投資者和媒體部分查看該業績。在介紹本季度的業績之前，我想先簡要討論一下我們在今天早上提交的 8-K 中描述的會計問題。在第二季審查期間，我們發現了一個錯誤，該錯誤被認為與 2021 年起單筆限制性股票授予的費用確認無關。該錯誤僅發生在 2021 年和 2022 年，不會影響任何其他或後續期間的營運結果。

Although the error was determined to be immaterial to all relevant financial statements, it was determined that this represented material weakness in the company's internal control over financial reporting related to controls around non-routine stock awards, which will require some disclosure in our 10-Q this quarter and an amendment to our 2023 10-K that will be filed later this week. We are already in the process of updating our internal controls relative to these equity grants and expect the material weakness will be fully remediated before December 31 of this year. Now, let's turn to the financial results for the quarter. We are pleased to report that we were both cash flow positive and generated net income in the second quarter of '24. We ended the quarter with approximately $217 million in cash, cash equivalents and investment securities, up $7 million from Q1 and flat from year end.

儘管該錯誤被確定對所有相關財務報表無關緊要，但確定這代表了公司對與非常規股票獎勵控制相關的財務報告的內部控制存在重大缺陷，這將需要在我們的 10 季度報告中進行一些披露本季度以及將於本週稍後提交的2023 年10-K 修正案。我們已經在更新與這些股權授予相關的內部控制，並預計重大缺陷將在今年 12 月 31 日之前完全糾正。現在，讓我們來看看本季的財務表現。我們很高興地報告，我們在 2024 年第二季度實現了正現金流並產生了淨利潤。本季末，我們的現金、現金等價物和投資證券約為 2.17 億美元，比第一季增加 700 萬美元，與年底持平。

This was of course made possible by the strong quarter of BRIUMVI with $72.6 million of US BRIUMVI net product revenue, which is up more than 350% over the comparable quarter in '23. Our OpEx excluding non-cash items during the second quarter came in below guided ranges at approximately $47 million, roughly in line with Q1 '24 when excluding the one-time charges seen during Q1 2024. Our OpEx for the first six months of 2024 is approximately $105 million. We're averaging just over $50 million per quarter, again below our guided range.

當然，這得益於 BRIUMVI 季度的強勁表現，美國 BRIUMVI 產品淨收入為 7,260 萬美元，比 2023 年同期增長了 350% 以上。我們第二季的營運支出（不包括非現金項目）低於指引範圍，約 4,700 萬美元，大致與 24 年第一季（不包括 2024 年第一季的一次性費用）一致。我們 2024 年前六個月的營運支出約為 1.05 億美元。我們的平均每季略高於 5000 萬美元，再次低於我們的指導範圍。

As discussed briefly earlier, our GAAP net income for the three months ended was $6.9 million or $0.04 per diluted share. When excluding non-cash items, net income for the period was approximately $16.4 million. And finally, I'll close by touching briefly on today's announcement of a new $250 million debt facility with Healthcare Royalty and Blue Owl Capital. We were pleased to be able to refinance our existing debt to a facility with a longer term duration and attractive financial terms. As Mike discussed, this will provide us with sufficient resources to execute on our share repurchase program also announced today as well as continue to invest in the BRIUMVI commercial opportunity.

正如之前簡要討論的那樣，我們截至三個月的 GAAP 淨利潤為 690 萬美元，即稀釋後每股收益 0.04 美元。排除非現金項目後，該期間淨利潤約為 1,640 萬美元。最後，我將簡要介紹今天宣布的與 Healthcare Royal 和 Blue Owl Capital 達成的 2.5 億美元新債務融資協議。我們很高興能夠將我們現有的債務再融資到期限較長且財務條款有吸引力的機構。正如麥克所討論的，這將為我們提供足夠的資源來執行今天宣布的股票回購計劃，並繼續投資 BRIUMVI 商業機會。

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

現在，我將把電話轉回給會議接線員以開始問答。

(Operator Instructions) Roger Song, Jefferies.

（操作員說明） Roger Song，Jefferies。

Maybe the first one, Mike, you can comment on the current dynamic market share? As we recall, [we] have been seeing you're getting around 10%, just curious about this quarter? And then also what's the near term goal for the dynamic market share understanding you want to become the number one dynamic market share in the future?

也許是第一個，麥克，您可以評論一下當前動態的市場份額嗎？我們記得，[我們] 看到您的收益約為 10%，只是對這個季度感到好奇？然後，對於動態市場份額的理解，您希望成為未來動態市場份額第一的近期目標是什麼？

Yes, of course, our goal is to get to that number one position. We're working hard at it. We got to have a goal, so we're going to keep driving at it. Yes, I mean, look, I don't know, with 1,400 out of 10,000 approx -- I mean, again, remember we're using approximate numbers, but we assume again, about 10,000 patients will start a new therapy. So that's the dynamic share per quarter.

是的，當然，我們的目標是達到第一名的位置。我們正在努力。我們必須有一個目標，所以我們將繼續努力實現它。是的，我的意思是，看，我不知道，大約10,000 名患者中有1,400 名——我的意思是，再次記住我們使用的是近似數字，但我們再次假設，大約10,000 名患者將開始新的治療。這就是每季的動態份額。

If we had 1,400 enrollments into the hub, which as Adam said, probably represents only about 80%, 85% of the total prescriptions, we are tracking toward sort of into that 15%-ish range give or take. But again, it's not fully baked. But yes, I think we're doing great. I mean, the team is out there hustling, they're working hard. The drug is performing well and we're going to continue to push toward our goal.

如果我們有 1,400 個註冊中心，正如 Adam 所說，這可能只佔處方總數的 80%、85% 左右，我們正在追蹤到 15% 左右的範圍。但同樣，它還沒有完全烘烤。但是，是的，我認為我們做得很好。我的意思是，團隊正在忙碌，他們正在努力工作。該藥物表現良好，我們將繼續努力實現我們的目標。

Excellent. Thank you. And then in terms of the allo CD19 CAR, your first indication of progressive MS, just biologically, can you comment on how you think about the CD19 versus CD20 for this particular sub population of the MS? And then also, when you start the trial, what are the targeted population for the progressive MS if you are targeting certain severity or any baseline characteristics you want to do the initial study?

出色的。謝謝。然後，就 allo CD19 CAR 而言，您對進行性 MS 的第一個跡象，從生物學角度來說，您能否評論一下您如何看待 CD19 與 CD20 對於 MS 的這個特定亞群的看法？另外，當您開始試驗時，如果您的初始研究目標是特定的嚴重程度或任何基線特徵，那麼進行性多發性硬化症的目標群體是什麼？

Thanks, Roger. So yes, I mean, CD20 versus CD19, I don't know that there's a huge difference in MS specifically. I mean, CD19 has a broader coverage in pre-B cells and short-lived plasma cells, which has some advantages in some areas, potentially some disadvantage in others. And that might be disadvantageous in MS if you were constantly treating these patients given that we think this will be a one-time treatment, or if it's not one-time, it'll be separated by a significant amount of time. I think the CD19 is quite a good approach for MS.

謝謝，羅傑。所以，是的，我的意思是，CD20 與 CD19，我不知道 MS 方面是否存在巨大差異。我的意思是，CD19 在前 B 細胞和短命漿細胞中具有更廣泛的覆蓋範圍，這在某些領域具有一些優勢，但在其他領域可能存在一些劣勢。如果您不斷地治療這些患者，那麼這對多發性硬化症可能是不利的，因為我們認為這將是一次性治療，或者如果不是一次性治療，則相隔很長一段時間。我認為CD19對於MS來說是一個非常好的方法。

And again, the goal for this treatment would be to have a very deep and robust B cell depletion across tissues within the systemic system. But of course, in the central that would create potentially a best-in-class treatment. And then you release and you hopefully let the B cells come back. Hopefully they're reset to be non-immunogenic B cells and that would be ideal. And of course, you'd be able to then leave long gaps, potentially use it as a one-time treatment or very long gaps between treatment.

再說一次，這種治療的目標是在全身系統內的組織中進行非常深入且強大的 B 細胞消除。但當然，在中央，這可能會創造出一流的治療方法。然後釋放，希望 B 細胞能回來。希望它們能被重置為非免疫原性 B 細胞，那就太理想了。當然，您可以留下很長的間隙，可能會將其用作一次性治療或治療之間很長的間隙。

So I think generally speaking, CD20 probably -- if you're going to be repeating treatments, probably CD20 a little bit better for MS. If you're looking at something that has a one-time treatment, CD19 may have some advantages in that case. You had a second part to that question, Roger, which of course, I lost myself in the answer, but is there more to that question?

所以我認為一般來說，CD20 可能 - 如果您要重複治療，CD20 可能對 MS 更好一些。如果您正在尋找一次性治療的藥物，CD19 在這種情況下可能有一些優勢。羅傑，你對這個問題還有第二部分，當然，我在答案中迷失了自己，但是這個問題還有更多嗎？

Yes, just curious about the progressive MS, any specific baseline population or baseline patient characteristics you want to target in your initial clinical trial?

是的，只是對進行性多發性硬化症感到好奇，您希望在初始臨床試驗中針對任何特定的基線人群或基線患者特徵？

Not really. No. I mean, I think we're open to all progressive patients, so that is definitely the unmet medical need in MS right now. So yes, we're excited to get into those patients. So it could be primary progressive, it could be secondary progressive, secondary progressive that are inactive, secondary progressive that are active.

並不真地。不。我的意思是，我認為我們對所有進展的患者開放，所以這絕對是多發性硬化症目前未滿足的醫療需求。所以，是的，我們很高興能接觸到這些患者。因此，它可能是原發性進行性，也可能是繼發性進行性，次要進行性是不活躍的，次要進行性是活躍的。

We're sort of agnostic to that group. We just want to make sure we're hitting progressive patients and hopefully, like I said, deep tissue penetration and CNS penetration would be great for that disease.

我們對這個群體有點不可知。我們只是想確保我們治療的是進展性患者，希望像我說的那樣，深層組織滲透和中樞神經系統滲透對治療這種疾病很有幫助。

Got it. Thank you. Thanks a lot.

知道了。謝謝。多謝。

Matt Kaplan, Ladenburg Thalmann.

馬特卡普蘭，拉登堡塔爾曼。

I guess a few questions. First on the pipeline you mentioned that you started the subcu program. Can you give us a little bit more sense in terms of potential profile of your subcu from a frequency and delivery point of view?

我想有幾個問題。首先在管道上您提到您啟動了 subcu 程式。您能否從頻率和交付的角度讓我們更了解您的 subcu 的潛在概況？

Yes. So there is one subcu on the market. It's currently dosed once per month in a, I'd say, relatively elegant auto injector format. But it still needs to be taken once a month, and you still have to deal with getting that drug to the patient once a month. So there's definitely logistical issues that can arise.

是的。所以市面上就有一種subcu。目前，它每月一次，我想說，是一種相對優雅的自動注射器形式。但它仍然需要每月服用一次，而且您仍然必須每月一次將這種藥物送給患者。所以一定會出現後勤問題。

The other that is not yet in the market, but potentially could be here in September, is a subcu version of Ocrevus. That one is a bit more clunky. You need to either have it pushed over 10 minutes to 15 minutes by a healthcare provider or used with a pump format where they attach a pump, but it will cause some bruising, some swelling, some reaction. So I think that's a bit more clunky than the elegance of a subcu auto injector. Our goal is to find ourselves somewhere in the middle, something that's less frequent than -- and the subcu Ocrevus will be every six months if it's approved.

另一個尚未上市，但可能會在 9 月上市，是 Ocrevus 的 subcu 版本。那個有點笨重。您需要由醫療保健提供者將其推壓 10 分鐘到 15 分鐘，或與附有泵的泵形式一起使用，但這會導致一些瘀傷、一些腫脹和一些反應。所以我認為這比優雅的 subcu 自動注射器更笨重。我們的目標是找到自己處於中間的某個位置，頻率低於——如果獲得批准，subcu Ocrevus 將每六個月一次。

The goal is to have something that's less frequently than once a month and more elegant than large volume subcu that is seen with the Ocrevus. So yes, I mean, look, we think the elegance of subcu auto injector is the gold standard. And we'd like to get ourselves there, and we'd just like it to be less frequently than once a month.

我們的目標是擁有頻率低於每月一次且比 Ocrevus 所見的大容量 subcu 更優雅的東西。所以是的，我的意思是，我們認為 subcu 自動注射器的優雅是黃金標準。我們希望自己能做到這一點，而且我們只是希望頻率低於每月一次。

Okay, that's helpful. Thank you. In your prepared remarks, you mentioned along with your guidance -- increased guidance, some seasonality to expect between second quarter to third quarter versus third to fourth. Can you talk a little bit about that, how we should think about that? And then also congrats on your first quarter in terms of achieving profitability from your underlying business. Is that something we should expect kind of going forward?

好的，這很有幫助。謝謝。在您準備好的演講中，您提到了您的指導意見——增加的指導意見，以及第二季到第三季與第三季到第四季之間預期的一些季節性因素。您能談談我們應該如何思考這個問題嗎？然後也祝賀您第一季從基礎業務中實現盈利。這是我們該期待的事嗎？

Sure. Adam, you want to take that seasonality question and then we'll come back to the profitability question?

當然。Adam，您想回答季節性問題，然後我們再回到獲利能力問題嗎？

Sure, yes. Historically, we have seen the MS market does tend to slow down [touching] -- in the summer months you have both patients and physicians taking vacations. So you have seen that historically, and we saw it last year, so we would expect to see it this year. You also have the added -- with this year being a little bit unique in the ACTRIMS conference has moved into quarter three versus quarter four last year. And we did see some softening around ACTRIMS last year with a lot of physicians from the US.

當然，是的。從歷史上看，我們看到多發性硬化症市場確實趨於放緩[感人]——在夏季，患者和醫生都會休假。所以你在歷史上已經看到了這一點，我們去年也看到了這一點，所以我們預計今年也會看到這一點。您還需要補充一點——今年的 ACTRIMS 會議有點獨特，與去年的第四季相比，今年的 ACTRIMS 會議已經進入了第三季。去年我們確實看到許多來自美國的醫生對 ACTRIMS 的態度有所軟化。

attending that conference. So those two things we think will contribute to the guidance that we provided. But overall, we're very confident, obviously in the long-term. We've raised our full year guidance and that's just more of a seasonality (inaudible).

參加那次會議。因此，我們認為這兩件事將有助於我們提供的指導。但總的來說，我們非常有信心，尤其是從長遠來看。我們提高了全年指導，這更多的是季節性的（聽不清楚）。

And then on the profitability side I'll take a crack and Sean's here to help and correct me if I get this wrong. But I think on an operating basis, we should maintain profitability going forward. Again, those are impacted -- on a GAAP basis that will be impacted, or net income will be impacted by things like non-cash comp. Our cash flow profitability will be impacted by things like inventory build. So we're in that sort of fringe area where some of those things will affect.

然後在盈利方面，我會嘗試一下，如果我弄錯了，肖恩會在這裡幫助和糾正我。但我認為，從營運角度來看，我們未來應該保持獲利能力。同樣，這些都會受到影響——按照公認會計準則計算，淨利潤將受到非現金補償等因素的影響。我們的現金流獲利能力將受到庫存建設等因素的影響。所以我們處於那種邊緣區域，其中一些事情會產生影響。

But I assume, as we get further into the year, we'll get closer and closer to both, regardless of whether we're buying inventory or regardless of the non-GAAP -- or non-cash stuff, we'll maintain both positive net income and cash flow. But certainly on an operations basis, as you can see, the expenses, as Sean mentioned, are even lower than expected. We're trying to spend it, we've added to our team, we're increasing our marketing budget, we're continuing to do that, we will continue to do that. But certainly we don't expect that the expenses could outpace the revenue growth at this point. Sean, anything to add on top of that?

但我認為，隨著今年的深入，我們將越來越接近兩者，無論我們是否購買庫存，無論非公認會計準則或非現金內容，我們都會維持兩者淨利潤和現金流為正。但當然，正如您所看到的，在營運基礎上，正如肖恩所提到的那樣，費用甚至低於預期。我們正在努力花掉它，我們已經增加了我們的團隊，我們正在增加我們的行銷預算，我們將繼續這樣做，我們將繼續這樣做。但我們當然預期目前支出的成長速度不會超過收入的成長速度。肖恩，除此之外還有什麼要補充的嗎？

No, I think you nailed it, Mike. I think that's perfect.

不，我想你已經成功了，麥克。我認為這很完美。

Thanks. Thanks, Mike.

謝謝。謝謝，麥克。

Michael DiFiore, Evercore ISI.

邁克爾·迪菲奧裡，Evercore ISI。

A few questions from me. Number one, like how do you perceive the initial launch of subcu Ocrevus impacting account penetration for the balance of the year? I mean, you've obviously increased guidance, but I was wondering if you're hearing anything from the field that may have helped boost your outlook in this regard? And I have two follow ups.

我有幾個問題。第一，您如何看待 subcu Ocrevus 的首次推出對今年剩餘時間的帳戶滲透率的影響？我的意思是，您顯然增加了指導，但我想知道您是否從該領域聽到了任何可能有助於提高您在這方面的前景的信息？我有兩個後續行動。

Sure. Adam, you want to go ahead and talk a little about what we're expecting from the launch of subcu Ocrevus?

當然。Adam，您想繼續談談我們對 subcu Ocrevus 的推出有何期待嗎？

Sure. Our teams are obviously -- will be prepped and ready for the launch of the product [extension] there for Ocrevus. But honestly, we haven't detected a lot of enthusiasm for this product with our customer base. We've heard concerns around complex administration nurse training required, potential side effect profile. So our interpretation today is we don't think it will have a significant impact in the US.

當然。顯然，我們的團隊已經做好準備，為 Ocrevus 推出產品[擴展]。但老實說，我們還沒有發現我們的客戶群對產品有很大的熱情。我們聽說過對複雜的管理護士培訓所需的擔憂以及潛在的副作用。所以我們今天的解釋是我們認為它不會對美國產生重大影響。

market. But that's today we sit here and that's our view from talking to many, many customers.

市場。但這就是我們今天坐在這裡，這是我們與許多客戶交談後的觀點。

That's helpful. Second question is just, any update on gross-to-net dynamics in Q2, any outlook for the balance of the year, as well as if you could comment on any inventory dynamics in Q2?

這很有幫助。第二個問題是，第二季總淨值動態有什麼更新嗎？

Sorry, Mike, could you repeat the first part of that question?

抱歉，麥克，你能重複這個問題的第一部分嗎？

Yes, I was wondering if you could just clarify or -- any gross-to-net dynamics in Q2 and the outlook on gross-to-net for the balance of the year, as well as comment on whether there was any inventory dynamics to be noted in 2Q?

是的，我想知道您是否可以澄清或 - 第二季度的總淨值動態以及今年剩餘時間的總淨值展望，以及評論是否存在任何庫存動態2Q要注意什麼？

Yes. Gross-to-net was similar to previous quarters and no material change, and inventory, nothing to note. Nothing that was unexpected.

是的。毛淨值與前幾季相似，沒有重大變化，庫存也沒有什麼值得注意的。沒有什麼是出乎意料的。

My final question to you, any update on the [EU] launch? I mean, any feedback from large academic centers there, and have you noticed any notable differences compared to the initial rollout of BRIUMVI in the US?

我問你的最後一個問題是，[EU] 發布有任何更新嗎？我的意思是，來自那裡的大型學術中心的任何反饋，以及與 BRIUMVI 在美國最初推出相比，您是否注意到任何顯著差異？

Yes. Mike, you want me take that one?

是的。麥克，你想讓我拿那個嗎？

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

亞當，你進展順利。繼續前進。

So [as you know], Mike, they launched it in Germany. We're still preparing for the launch, waiting for reimbursement on several other countries. But the feedback has been very positive. They are gaining momentum both in the academic centers, but also interestingly in the community centers as well. They're getting feedback that the 1-hour infusion is particularly attractive in those centers from an efficiency standpoint.

[如你所知]，麥克，他們在德國推出了它。我們仍在為發布做準備，等待其他幾個國家的退款。但反饋非常正面。他們在學術中心和社區中心都獲得了發展動力。他們得到的回饋表明，從效率的角度來看，1 小時輸液在這些中心特別有吸引力。

So overall, it's been going well. As far as the comparison to the US launch, I think similar in that there is good uptake and enthusiasm for the product profile. And we'll see how they continue to go there and we're looking forward to seeing more countries launch in -- later this year or early next year.

所以總的來說，一切進展順利。就與在美國推出的產品相比，我認為相似之處在於產品簡介受到了良好的接受和熱情。我們將看到他們如何繼續去那裡，我們期待看到更多的國家在今年晚些時候或明年初推出。

Eric Joseph, JPMorgan.

艾瑞克‧約瑟夫，摩根大通。

Congrats on a great quarter and thanks for taking the questions. I guess just first on the updated guidance, I guess, what does that anticipate [in terms of] pull through via the VA contract, I guess any sort of range you can kind of put around that? And then, I'm also curious to know what kind of incremental visibility you had this quarter on [inter] CD20 switching to BRIUMVI? How much switches contributed to BRIUMVI uptake, and also where you think that might go with additional data from the enhanced trial? And then secondly Mike, you commented on sort of additional expenditure to support the launch here. I guess, how should we be thinking about sort of the build and SG&A the next couple of quarters, and I guess ultimately looking long-term, I guess, how should be thinking about sort of the commercial margin, the profitability of the BRIUMVI franchise?

恭喜您度過了一個出色的季度，並感謝您提出問題。我想首先是關於更新後的指導，我想，透過 VA 合約預計會實現什麼，我想你可以圍繞它制定任何類型的範圍？然後，我也很想知道本季你們對 [inter] CD20 切換到 BRIUMVI 的了解程度如何？有多少開關對 BRIUMVI 的採用做出了貢獻，您認為這可能與增強試驗中的其他數據有關？其次，麥克，您評論了支持此處發布的額外支出。我想，我們應該如何考慮接下來幾季的建設和銷售管理費用，我想最終要著眼於長期，我想，應該如何考慮商業利潤，BRIUMVI 特許經營權的盈利能力？

Sure. Thanks, Eric, [for] the three-part questionnaire. I think Adam, if you want, maybe the first one was updated guidance, how it may be impacted by the VA? Do you want to start there?

當然。謝謝艾瑞克（Eric）提供的三部分的問卷。我想 Adam，如果你願意的話，也許第一個指南是更新的指南，它可能會受到 VA 的影響嗎？你想從那裡開始嗎？

Yes. So the guidance includes the VA, but I would say that the VA, I think we mentioned on the call last time, would not be a material impact in 2024. We're in the early stages of the launch at the VA. It's been about a month since the contract went into place. At this point, I would say 10% to 15% perhaps of the VA centers of excellence have utilized BRIUMVI.

是的。因此，指導意見包括 VA，但我認為我們上次在電話會議中提到的 VA 不會對 2024 年產生重大影響。我們正處於 VA 推出的早期階段。距離合約生效已經過去一個月了。在這一點上，我想說，也許 10% 到 15% 的 VA 卓越中心已經使用了 BRIUMVI。

It's -- The contract is specifically for new patients. And so I don't expect -- although our guidance includes, it's not a major driver of the overall guidance. And then your second question was on switches from CD20. Switches from CD20 remain consistent quarter-to-quarter. We've seen a good amount of our overall patient population being switched from CD20.

該合約是專門針對新患者的。所以我不認為——儘管我們的指導包括在內，但這並不是整體指導的主要驅動力。然後你的第二個問題是關於 CD20 的開關。CD20 的轉換每季都保持一致。我們已經看到我們的整體患者群體中有很大一部分從 CD20 轉為使用。

And yes, we would expect with more data in the ENHANCE trial and making it easier to switch patients. We know that there are many patients that complain of crap-gap and other issues around tolerability of other CD20s. And we believe it's an attractive market, and it's been nice to see it stay consistent since launch in terms of percentage of patients switching over from CD20. And then I don't remember the third part.

是的，我們期望 ENHANCE 試驗中能提供更多數據，並使更換患者更容易。我們知道，有許多患者抱怨其他 CD20 的耐受性差和其他問題。我們相信這是一個有吸引力的市場，很高興看到它自推出以來在從 CD20 轉換的患者百分比方面保持穩定。然後我不記得第三部分了。

Yes, I've got that one. That one was directed at me, so -- although you could help him, so could Sean probably. But -- so the question was on the launch, build and SG&A and then sort of long-term where we see that going. So, yes, I mean, look, we had a very focused strategy when we started the launch and we sized the team for that strategy. And we always said that we will grow the team and basically reinvest the revenues to build out the team.

是的，我有那個。那是針對我的，所以——雖然你可以幫助他，肖恩也可能可以。但是，問題在於發布、建立和銷售、一般行政管理費用，以及我們看到的長期發展方向。所以，是的，我的意思是，看，當我們開始發佈時，我們有一個非常集中的策略，並且我們根據該策略調整了團隊規模。我們總是說我們將發展團隊，並將收入重新投資來建立團隊。

The SG&A and total OpEx for this year of $250 million baked in a growth of the team. Over the course of the year, like I said, I think since the launch, certainly in like the core field teams themselves versus sort of management level positions, we've close to doubled, I think, our field force, or at least grown more than 50% the field force and that continues to grow. I mean, I get requests for new hires in the field nearly every day, certainly once or twice a week. So the team is growing, but that's, again, all baked into that that OpEx number of -- again, it's about $250 million, I'm not going to say exact, and obviously we've been running a little bit below for the year so far. But I think we're just going to still stick with approximately $250 million in OpEx for the year.

今年的 SG&A 和總營運支出為 2.5 億美元，這得益於團隊的成長。在這一年裡，就像我說的，我認為自啟動以來，當然就像核心現場團隊本身與管理級別職位一樣，我認為我們的現場人員幾乎增加了一倍，或者至少增長了超過50%的現場人員，而且這一數字還在持續增長。我的意思是，我幾乎每天都會收到該領域招募新員工的請求，當然每週一到兩次。因此，團隊正在成長，但這又全部融入了營運支出的數字中——同樣，大約是 2.5 億美元，我不會說確切的數字，顯然我們的營運支出略低於營運支出。 。但我認為今年我們仍將維持約 2.5 億美元的營運支出。

As we move into next year, I'm confident the OpEx that we target will be higher, I think incrementally higher. We're certainly -- like I said, the team will continue to grow our marketing budget. Again, we were very specific early on that we wanted to focus on clinician awareness, HCP awareness, and that was really a field-based endeavor. We're going to obviously continue to do that, and as we said, we're growing that. But Phase II of the launch, we've talked about this a bit, and we've already increased, again, which is already in this year's budget, our online direct to patient marketing efforts.

當我們進入明年時，我相信我們的目標營運支出將會更高，我認為會逐步提高。正如我所說，我們的團隊肯定會繼續增加行銷預算。同樣，我們很早就非常明確地表示，我們希望專注於臨床醫生的意識、HCP 的意識，這確實是一項基於現場的努力。顯然，我們將繼續這樣做，正如我們所說，我們正在擴大這一點。但是在啟動的第二階段，我們已經對此進行了一些討論，並且我們已經再次增加了我們的在線直接面向患者的營銷工作，這已經在今年的預算中。

And we're going to continue to grow that budget as we get into next year. Long-term, again, I can see we'll continue to incrementally -- at some point the team is probably fully maxed out. So that will cap out and then the marketing budget will be the marketing budget that we think is appropriate. But like I said, my hope and expectation is that our incremental spend in OpEx and SG&A over time is measured and incremental whereas the revenue should be relatively gapping up every year, and we have a really nice accumulation effect as we continue, hopefully to build our market share and grow that out. The new starts will continue to build as well.

進入明年，我們將繼續增加預算。從長遠來看，我再次看到我們將繼續逐步前進——到了某個時候，團隊可能已經完全耗盡了。因此，這將達到上限，然後行銷預算將是我們認為合適的行銷預算。但就像我說的，我的希望和期望是，隨著時間的推移，我們在OpEx 和SG&A 上的增量支出是可衡量的和增量的，而收入每年應該相對缺口，並且隨著我們的持續，我們會產生非常好的累積效應，希望能夠建立我們的市場份額並不斷擴大。新的開工項目也將繼續建設。

So all of that on top of -- itself is why I quoted earlier that I could potentially see significant cash flows as we move forward. But yes, I mean, I think long-term the margins should be solid. I mean, I've looked at some of the best operating margins in biotech out there. I've seen, I think Vertex, Regeneron have done an amazing job in keeping their OpEx high. There's a few other companies out there.

因此，所有這些本身就是我之前引用的原因，隨著我們的前進，我可能會看到大量現金流。但是，是的，我的意思是，我認為從長遠來看，利潤率應該是穩固的。我的意思是，我研究了生物技術領域中一些最好的營業利潤率。我認為 Vertex 和 Regeneron 在保持高營運支出方面做得非常出色。還有其他一些公司。

I think we could be in a leading position in terms of OpEx to revenue, so OpEx margins.

我認為我們在營運支出與收入之比以及營運支出利潤率方面可能處於領先地位。

Right. Great. Thanks for taking all the questions and again, congrats on the quarter.

正確的。偉大的。感謝您提出所有問題，再次恭喜本季。

Thanks, Eric. Appreciate it.

謝謝，埃里克。欣賞它。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley 證券。

Congrats on a solid quarter. So quick 2-part on commercial metrics. Adam, if you could update on the persistence rate you're seeing, and if you guys can qualitatively talk to an year-end market share target, be it within new-to-class or intra class sort of switch segments? And then I have a quick follow up.

恭喜季度業績穩健。關於商業指標的快速兩部分。Adam，您是否可以更新您所看到的持續率，並且您是否可以定性地討論年終市場份額目標，無論是在新類別還是內部類別的開關細分市場中？然後我會進行快速跟進。

Yes, the persistence rate at week 24 continues to be solid. And as expected, what we've said before is we expected it to be around high 80s. And that's what we saw -- at least what Ocrevus saw and we're [laid] in that ballpark. So the range is very strong there. In terms of market share, I'm not going to give a specific market share that we think we're going to hit by the end of the year.

是的，第 24 週的持續率持續保持穩定。正如預期的那樣，我們之前說過我們預計它會在 80 左右。這就是我們所看到的——至少是奧克雷弗斯所看到的，我們就在那個球場上。所以那裡的範圍非常強大。就市場佔有率而言，我不會給出我們認為到今年年底我們將達到的具體市場份額。

I just think to reiterate what Mike has said and what we said in the call, we're going to continue to add more and more prescribers and we're going to continue to grow in a growing market. And that's what we're focused on every day and we continue to see that we're getting traction and we'll continue to focus on doing that. And like I said, our goal is to be the number one prescribed MS therapy in terms of dynamic care.

我只是想重申麥克所說的話以及我們在電話中所說的話，我們將繼續增加越來越多的處方者，我們將在不斷增長的市場中繼續成長。這就是我們每天關注的重點，我們繼續看到我們正在獲得牽引力，我們將繼續專注於這樣做。正如我所說，我們的目標是成為動態護理方面排名第一的多發性硬化症治療藥物。

And then at ACTRIMS, I see you're presenting an update to ENHANCE study results. Maybe just talk to what's new and incremental there and what sort of the healthcare provider feedback to -- the data you've generated to date? And also, I noticed there's a deliberative Phase III [late] breaker, Gemini and Hercules program data coming also at ACTRIMS. Would love to hear your latest thoughts on how you are thinking -- the BTK drug class impact on your sort of long range plan, recognizing the results have been relatively mixed recently?

然後在 ACTRIMS 上，我看到您正在介紹 ENHANCE 研究結果的更新。也許只是談談那裡有什麼新的和增量的東西，以及醫療保健提供者對什麼樣的反饋——您迄今為止生成的數據？而且，我注意到 ACTRIMS 上也有一個經過深思熟慮的第三階段[晚期]突破者、雙子座和大力神計劃數據。很想聽聽您的最新想法—BTK 藥物類別對您的長期計劃的影響，並認識到最近的結果相對好壞參半？

Thanks for the questions. So obviously, we can't talk anything about ACTRIMS. The notifications and abstracts have not been released yet, so can't say anything about that. But I can answer your second part of your question about HCP feedback to the results we have presented previously. And I think the feedback has been extremely positive.

感謝您的提問。顯然，我們不能談論 ACTRIMS。通知和摘要尚未發布，因此無法對此發表任何評論。但我可以回答您關於 HCP 對我們之前提出的結果的回饋問題的第二部分。我認為反饋非常正面。

I think people -- intuitively, if they have a CD20 patient that walks in the door who's already relatively well B cell depleted but is having some other issue, whether it's crap-gap or had some relapse, they don't feel that there's a need to go through the 150 milligram dose, which is in some respects a de-bulking dose where we take down the B cells so we can give a full proper dose two weeks later at 450 milligrams in one hour. So yes, I think that the people are happy to see that -- happy and not surprised to see that you can safely transition those patients to do that. So, yes, I think that's a net positive thus far. And like I said, in the coming months, we'd like to present more data from that trial. In terms of BTK, I mean, look, I think most folks would believe at this point, regardless of whether one or several of the BTKs are successful in relapsing forms of MS, it's more likely than not to be an inferior profile to CD20.

我認為人們——直覺上，如果他們有一個 CD20 患者走進門，他的 B 細胞已經相對較好地耗盡，但有一些其他問題，無論是垃圾間隙還是有一些復發，他們不會覺得有需要接受150 毫克的劑量，從某些方面來說，這是一種減量劑量，我們可以減少B 細胞，這樣我們就可以在兩週後在一小時內給予完整的適當劑量，即450 毫克。所以，是的，我認為人們很高興看到這一點 - 很高興看到你可以安全地將這些患者轉移到這樣做，並且並不感到驚訝。所以，是的，我認為到目前為止這是一個淨積極的結果。正如我所說，在接下來的幾個月中，我們希望提供該試驗的更多數據。就 BTK 而言，我的意思是，看，我認為大多數人此時都會相信，無論一個或多個 BTK 是否成功治癒了 MS 的複發形式，它很可能比 CD20 遜色。

I don't think anyone believes that they are -- that BTKs in relapsing forms of MS will be more active, more convenient, less side effects than the CD20 gives at this point. So again, I think that's probably now a foregone conclusion, assuming that the studies in relapsing forms of MS are successful. Obviously, we've had some failures and some toxicity that's been seen along the way. So we sit and we'll wait and we'll see what the data looks like. But again, I think optimism is relatively low for these drugs and relapsing forms of MS.

我認為沒有人相信 BTK 在復發性多發性硬化症中會比 CD20 更有效、更方便、更副作用。再說一次，我認為，假設復發型多發性硬化症的研究取得成功，這可能已成定局。顯然，我們在過程中遇到了一些失敗和一些毒性。所以我們坐下來等待，看看數據是什麼樣的。但我再次認為，對於這些藥物和復發性多發性硬化症的樂觀情緒相對較低。

On the other side, I do think that there's a lot of excitement for the potential for these drugs in progressive forms of MS. I think in theory, if they would work in progressive MS, that would be phenomenal, right? As I mentioned earlier, we're looking at azer-cel and progressive forms of MS because that is the unmet medical need. That's the area that is most concerning and is least well-treated at this point. So I think there's excitement and enthusiasm for it.

另一方面，我確實認為這些藥物在治療進展型多發性硬化症的潛力令人興奮。我認為從理論上講，如果它們能在進展型多發性硬化症中發揮作用，那將是驚人的，對嗎？正如我之前提到的，我們正在研究 azer-cel 和進行性多發性硬化症，因為這是未滿足的醫療需求。這是目前最令人擔憂且處理最少的領域。所以我認為人們對此感到興奮和熱情。

If it works -- I think there's certainly a fair amount of pessimism that it will work. But again, anytime you have an unmet medical need, people are enthusiastic about the potential. So we shall see -- again, would be a very nice thing for patients if these work in progressive forms of MS. I think in relapsing forms of MS, it's not a concern of ours.

如果它有效的話——我認為肯定會有相當多的悲觀情緒認為它會有效。但同樣，每當您有未滿足的醫療需求時，人們都會對其潛力充滿熱情。因此，我們將再次看到，如果這些藥物對進展型多​​發性硬化症有效，那麼對患者來說將是一件非常好的事情。我認為對於復發性多發性硬化症，這不是我們關心的問題。

I understood, Mike. Thanks for that comprehensive answer. And congrats again on all the progress.

我明白了，麥克。感謝您的全面回答。再次恭喜所有的進展。

Prakhar Agrawal, Cantor Fitzgerald.

普拉哈·阿格拉沃爾，坎托·菲茨杰拉德。

Congrats on the quarter. So following up on the subcu Ocrevus uptake, based on your conversations in the field, do you expect the uptake to be similar or different between academic and community centers? And for the 1,000 or so physicians who have prescribed BRIUMVI, do you know whether the split of their IV versus subcu CD20 is similar or different than the overall market? And I had a follow up.

恭喜本季。那麼，根據您在該領域的對話，跟進 subcu Ocrevus 的採用情況，您預計學術中心和社區中心之間的採用情況是相似還是不同？對於 1,000 名左右開立 BRIUMVI 處方的醫生，您是否知道他們的 IV 與 subcu CD20 的比例與整體市場相似還是不同？我進行了跟進。

Yes. Adam, do you want to start on the first one?

是的。亞當，你想從第一個開始嗎？

Yes, so the first one -- Thanks for the question, Prakhar. The first one is where do we think the subcu pickup will be, right? So at this point, we can go by where [Roche] has guided, which is in places that don't have IV infrastructure. It's tough for us to tell exactly where this will be picked up. I don't know, and as I said earlier, we just don't detect a lot of overall enthusiasm for the product.

是的，第一個——謝謝你的提問，Prakhar。第一個是我們認為 subcu 皮卡會在哪裡，對嗎？因此，在這一點上，我們可以按照[羅氏]的指導，即那些沒有 IV 基礎設施的地方。我們很難確切地知道這些資訊將在哪裡被獲取。我不知道，正如我之前所說，我們只是沒有發現人們對該產品有很大的整體熱情。

So tough to say on that. And then you asked about what the IV versus subcu share -- could you just repeat that second part of the question? I want to make sure I get it right.

對此很難說。然後你問 IV 與 subcu 有什麼共同點──你能重複問題的第二部分嗎？我想確保我做對了。

Yes. So for the 1,000 physicians who have prescribed BRIUMVI so far, what's their share of IV versus subcu CD20?

是的。那麼，對於迄今為止開過 BRIUMVI 處方的 1,000 名醫生來說，他們靜脈注射與 subcu CD20 的比例是多少？

Yes Prakhar, I don't know that, but we are focused on prescribers that have significant IV share. So I don't know the exact answer to your question, but I guess that our prescribers have a higher IV share than subcu.

是的，Prakhar，我不知道，但我們關注的是擁有大量靜脈注射份額的處方者。所以我不知道你問題的確切答案，但我猜我們的處方者的靜脈注射份額比 subcu 更高。

And just as a follow up on BRIUMVI uptake and maybe mixed by academic and community centers, if you can provide more details around the uptake by these segments and maybe which segments are seeing the most growth right now for BRIUMVI and which segments are starting to moderate?

正如BRIUMVI 吸收率的後續行動，可能由學術和社區中心混合，如果您可以提供有關這些細分市場吸收率的更多詳細信息，也許哪些細分市場目前BRIUMVI 增長最快，哪些細分市場開始放緩？

Sure. Yes, as we've said in previous calls, we've seen the initial uptake was in the private practices as academic centers took longer from a formulary perspective and logistics. But we've seen significant growth in all segments. And particularly in the academic centers, we continue recently in the last two quarters to add -- to see more and more adds from a prescriber perspective within the hospital segment. In Q2, the BRIUMVI hospital segment saw its highest ever quarter-over-quarter growth in terms of absolute vials.

當然。是的，正如我們在之前的電話會議中所說的那樣，我們看到最初的採用是在私人診所中，因為學術中心從規範的角度和後勤方面花費了更長的時間。但我們看到所有細分市場都出現了顯著成長。特別是在學術中心，我們最近在過去兩個季度繼續增加——從醫院部門的處方者角度看到越來越多的增加。第二季度，BRIUMVI 醫院部門的絕對瓶數出現了有史以來最高的季度環比增長。

And now the hospital segment is the largest segment of our business today. But we're still seeing growth in both segments. And I think that's a testament to the profile of the drug and the success that we're seeing.

現在，醫院部門是我們當今業務中最大的部門。但我們仍然看到這兩個領域的成長。我認為這證明了該藥物的概況以及我們所看到的成功。

Ed White, H.C. Wainwright.

懷特，H.C.溫賴特。

So I just wanted to come back to the question on the VA contract. Adam had mentioned that it's not going to be really material in 2024. I was just wondering if you can give us your thoughts on the opportunity it represents in 2025 and beyond?

所以我想回到關於退伍軍人管理局合約的問題。Adam 曾提到，到 2024 年，這不會變得真正重要。我只是想知道您是否可以告訴我們您對 2025 年及以後所代表的機會的看法？

Sure. Thanks for the question. Yes, I mean what we said was this is a -- the contract is for new patients. And that will grow over time. I think the contract overall value was estimated about $187 million for the 5-year contract.

當然。謝謝你的提問。是的，我的意思是我們所說的是這是一份針對新患者的合約。隨著時間的推移，這種情況將會成長。我認為這份為期 5 年的合約總價值估計約為 1.87 億美元。

I think we'll see. I think we're determined to try to get every new patient that is available, and we'll continue to see how that will grow over time. We don't think -- Compared to our overall business, we don't think it's a huge percentage. But as I mentioned, the value there is -- there are a lot of physicians that are in the VA that also work in academia. Our hope is that, that will help to have a halo effect overall in the academic setting and also reinforce the overall profile of BRIUMVI and the value proposition that BRIUMVI brings.

我想我們會看到的。我認為我們決心嘗試吸引每位可用的新患者，我們將繼續觀察隨著時間的推移，這種情況會如何增長。我們認為—與我們的整體業務相比，我們認為這個比例並不大。但正如我所提到的，它的價值是——退伍軍人管理局的許多醫生也在學術界工作。我們希望，這將有助於在學術界產生整體光環效應，並強化 BRIUMVI 的整體形象和 BRIUMVI 帶來的價值主張。

And Adam, as the size of that business grows over the next couple of years, is there any impact to gross-to-net?

Adam，隨著未來幾年該業務規模的成長，對毛淨值有什麼影響嗎？

Sure. There'll be an impact to gross-to-net, for sure, given that it's public what we offered the drug at a discount. So that will affect gross-to-net. Yes.

當然。考慮到我們以折扣價提供的藥物是公開的，這肯定會對毛淨值產生影響。這將影響毛淨值。是的。

And perhaps my last question is just on the share repurchase program. Do you have any timelines for that? When are you going to start and any expectations of how long that program will continue to get to the $100 million?

也許我的最後一個問題只是關於股票回購計劃。有這方面的時間表嗎？您打算什麼時候開始？

Yes. So we expect to get started soon. I think we'll be measured in how we do it. So we'll be in open market purchases, sort of like a, I think a [10B 51] style of plan. And there is no fixed duration of time in which we will spend the $100 million in the repurchase.

是的。所以我們希望盡快開始。我認為我們將根據我們的做法來衡量。因此，我們將進行公開市場購買，我認為有點像 [10B 51] 風格的計劃。而且我們回購這1億美元的時間並沒有固定的期限。

And some of it we'll probably build in some share price targets so we can buy more at different levels. So yes, I think we're going to just think about it and try to buy back as many shares as we can with the money we have for the moment. Obviously, we expect that over time we'll get to reload and buy more shares, so as the revenues and cash flow continues. So I think for the moment we're going to just start the buying as soon as we can and we'll see how it goes.

其中一些我們可能會設定一些股價目標，這樣我們就可以在不同水準上購買更多股票。所以，是的，我認為我們會考慮一下，並嘗試用目前擁有的資金回購盡可能多的股票。顯然，我們預計隨著時間的推移，我們將重新加載並購買更多股票，以便收入和現金流持續成長。所以我認為目前我們將盡快開始購買，然後看看進展如何。

Okay, great. Thanks for taking my questions. Thanks, Ed.

好的，太好了。感謝您回答我的問題。謝謝，艾德。

Corinne Jenkins, Goldman Sachs.

科琳·詹金斯，高盛。

This is Palak [on] for Corinne. Just one question for us here. You touched upon seasonality for the business into the second half of the year, but could you also highlight where you see room for potential upside to your revenue guidance?

我是 Corinne 的 Palak。這裡只有一個問題想問我們。您談到了下半年業務的季節性，但您能否也強調一下您認為收入指引有哪些潛在上升空間？

Adam, can you take that one?

亞當，你能拿走那個嗎？

Yes, for sure. Yes, seasonality was -- as I mentioned, was limited to Q3. As I mentioned, that is -- historically affects the entire MS market and probably disproportionately affects IV therapies just given vacation and so on and so forth. As we've noted also, we've raised the full year guidance for the year, which shows that we're confident in the overall growth story here. And I think upside would be continued growth and pick up both on the new patient side and as patients come back, we're going to start seeing the repeat prescriptions continue to grow as new patients continue to grow.

是的，當然。是的，正如我所提到的，季節性僅限於第三季。正如我所提到的，這在歷史上影響了整個多發性硬化症市場，並且可能不成比例地影響剛休假的靜脈注射療法等等。正如我們也指出的那樣，我們提高了今年的全年指導，這表明我們對這裡的整體成長故事充滿信心。我認為好處是新患者的持續增長和回升，隨著患者回來，我們將開始看到重複處方隨著新患者的持續增長而繼續增長。

And if that grows faster than we would expect, I think there's certainly potential upside.

如果成長速度快於我們的預期，我認為肯定有潛在的上升空間。

We've reached the end of the question-and-answer session. I'll now turn the call over to Mike Weiss for closing remarks.

我們的問答環節已經結束。現在我將把電話轉給邁克·韋斯 (Mike Weiss) 致閉幕詞。

Great. Thank you, and thanks, everyone, again for joining us on today's call. We look forward to continuing the positive momentum into the second half of 2024. And as discussed today, we'll continue to be focused on several key priorities. First, expanding BRIUMVI's reach to ensure all eligible patients can benefit from this innovative medicine.

偉大的。謝謝大家，再次感謝大家加入我們今天的電話會議。我們期待在 2024 年下半年繼續保持積極勢頭。正如今天所討論的，我們將繼續關注幾個關鍵優先事項。首先，擴大 BRIUMVI 的覆蓋範圍，確保所有符合條件的患者都能從這種創新藥物中受益。

That includes building out our commercial footprint and increasing our spending on marketing efforts. Next, advancing our BRIUMVI expansion initiatives through our subcutaneous development, our ENHANCE switch study and exploring new indications for BRIUMVI. Finally, commencing our Phase I for azer-cel and progressive MS, as well as looking at opportunities to expand our pipeline. With that, I'd like to close by thanking the patients and clinicians that put their trust in TG and BRIUMVI and our loyal shareholders for their support and once again, the whole TG team for making it happen. Have a nice day.

這包括擴大我們的商業足跡並增加我們的行銷支出。接下來，透過我們的皮下開發、我們的 ENHANCE 開關研究和探索 BRIUMVI 的新適應症來推進我們的 BRIUMVI 擴張計劃。最後，開始 azer-cel 和漸進式 MS 的第一階段，並尋找機會擴大我們的產品線。最後，我要感謝信任 TG 和 BRIUMVI 的患者和臨床醫生以及我們忠誠的股東的支持，並再次感謝整個 TG 團隊讓這一切成為現實。祝你今天過得愉快。

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

今天的會議到此結束。現在讓我斷開你們的線路。感謝您的參與。