TG Therapeutics, Inc. (TGTX) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Greetings, and welcome to the TG Therapeutics first quarter conference call and webcast. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce Jenna Bosco, Chief Communications Officer. Thank you. You may begin.

    各位好,歡迎參加 TG Therapeutics 2026 年第一季財報電話會議與網路直播。(接線員指示)提醒各位,本次會議將被錄音。現在我很榮幸介紹首席傳播長 Jenna Bosco。謝謝。您可以開始了。

  • Jenna Bosco - Chief Commercial Officer

    Jenna Bosco - Chief Commercial Officer

  • Thank you. Welcome, everyone, and thank you for joining us this morning. I'm Jenna Bosco, and with me to discuss TG Therapeutics first quarter 2026 financial results are Michael Weiss, our Chairman and Chief Executive Officer; Adam Waldman, our Chief Commercial Officer; and Sean Power, our Chief Financial Officer.

    謝謝。歡迎各位,也感謝各位今天早上加入我們。我是 Jenna Bosco。與我一同討論 TG Therapeutics 2026 年第一季財務業績的有:我們的董事長兼執行長 Michael Weiss;首席商務長 Adam Waldman;以及首席財務長 Sean Power。

  • 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.

    在我們的安全港聲明之後,Mike 將先概述近期的公司發展。Adam 將提供商業推進的最新進展,Sean 將回顧財務結果,之後我們將開放問答。

  • Before we begin, I'd 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 outlook for our marketed products and our pipeline products.

    在開始之前,我想提醒各位,今天的討論將包含《1995 年私人證券訴訟改革法》所定義的前瞻性陳述。這些陳述可能包括對我們未來營運與財務表現的預期,包括銷售趨勢、營收指引、預計里程碑、開發計畫,以及我們已上市產品與研發管線產品的展望。

  • Please note that these statements are subject to risks and uncertainties that can 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.

    請注意,這些陳述受到風險與不確定性影響,可能導致我們的實際結果與所述內容存在重大差異。相關風險已在我們向 SEC 提交的文件中詳述。此外,今天所作的任何前瞻性陳述僅反映截至本日的觀點,我們不承擔更新或修訂的任何義務。

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

    提醒各位,本次電話會議將被錄音,並將在未來 30 天於我們的網站 www.tgtherapeutics.com 提供重播。接下來我將把電話交給我們的執行長 Mike Weiss。

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Jenna, and good morning, everyone. We appreciate you joining us. The first quarter of 2026 was, in my view, exceptional, not because of any single milestone, but because of the consistency and durability we're now seeing across the business. Let me start with the commercial side.

    謝謝你,Jenna,各位早安。感謝各位加入我們。我認為 2026 年第一季表現非常出色,不是因為某一個單一里程碑,而是因為我們現在在整體業務上看到的穩定性與持久性。先從商業面談起。

  • At a high level, Q1 was a record-setting quarter across nearly every metric we track. The momentum puts us in a very strong position as we move through the rest of the year. From a revenue standpoint, we delivered approximately $195 million in US, BRIUMVI net product revenue in quarter one, ahead of our guidance of $185 million to $190 million. On a global basis, revenue exceeded $200 million for the quarter, marking another important milestone.

    整體而言,第一季在我們追蹤的幾乎每一項指標上都創下紀錄。這股動能讓我們在接下來的年度進程中處於非常有利的位置。就營收而言,我們第一季在美國的 BRIUMVI 淨產品營收約為 1.95 億美元,高於我們 1.85 億至 1.90 億美元的指引。以全球來看,本季營收超過 2 億美元,達成另一個重要里程碑。

  • And as we move toward $1 billion annualized run rate expected before year-end, we continue to believe we are still early in the BRIUMVI adoption curve, making peak revenue from the IV franchise alone still years ahead of us and multiples of where we are today.

    隨著我們朝向在年底前達到年化 10 億美元的運行率(run rate)目標邁進,我們仍然相信 BRIUMVI 的採用曲線仍處於早期階段,僅 IV 特許經營(franchise)的峰值營收仍在數年之後,且將是目前水準的數倍。

  • Physicians are increasingly recognizing the value of BRIUMVI, not just on efficacy, but on the overall treatment experience, thus translating into durable, repeatable growth. And importantly, the data continues to support that differentiation.

    醫師愈來愈認可 BRIUMVI 的價值,不僅在療效上,也在整體治療體驗上,進而轉化為可持續、可重複的成長。更重要的是,數據持續支持這項差異化。

  • Earlier this year, we were pleased to see our five-year follow-up data from the ULTIMATE I and II open-label extension study published in JAMA Neurology, reinforcing sustained efficacy of BRIUMVI along with a consistent safety and tolerability profile over time.

    今年稍早,我們很高興看到 ULTIMATE I 與 II 開放標籤延伸研究的五年追蹤數據發表於《JAMA Neurology》,再次強化 BRIUMVI 的持續療效,以及隨時間維持一致的安全性與耐受性特徵。

  • At AAN earlier this month, we continue to build on that story with real-world data demonstrating sustained and rapid B-cell depletion, low annualized relapse rates maintained over time and continued evidence of a favorable infusion experience and tolerability profile.

    在本月稍早的 AAN 會議上,我們以真實世界數據延續這個故事,顯示 B 細胞可持續且快速耗竭、低年化復發率可隨時間維持,並持續證實良好的輸注體驗與耐受性特徵。

  • And for the first time, we presented prospective data from patients who switched from a prior anti-CD20 therapy to BRIUMVI, which showed improvement in patient-reported wearing off symptoms, sometimes referred to as the clot gap after switching to BRIUMVI. Given that meaningful number of patients report this wearing off effect, the potential to address it represents a clear and differentiated use case. Turning to the pipeline.

    此外,我們首次發表前瞻性數據,來自先前使用抗 CD20 治療後轉換至 BRIUMVI 的患者;結果顯示患者自述的「藥效消退(wearing off)」症狀有所改善,這種現象在改用 BRIUMVI 後有時也被稱為「clot gap」。鑑於有相當比例的患者回報此類藥效消退效應,能夠加以改善代表一個明確且具差異化的使用情境。接下來談研發管線。

  • This is where we continue to invest in both strengthen and extend the franchise. First, our Phase 2 ENHANCE study, evaluating initiation of BRIUMVI therapy with a single 600-milligram IV infusion as compared to the currently approved schedule of 600 milligrams divided into two infusions, on day one and on day 15. I'm pleased to report that based on current timelines; we expect top line data from this Phase 3 study in the coming weeks.

    在這方面,我們持續投資以強化並延伸特許經營。首先,我們的第 2 期 ENHANCE 研究,評估以單次 600 毫克 IV 輸注啟動 BRIUMVI 治療,相較於目前核准的給藥時程:600 毫克分兩次輸注,分別在第 1 天與第 15 天。我很高興報告,依照目前時程,我們預期將在未來幾週取得此第 3 期研究的主要(top line)數據。

  • Assuming a positive outcome and regulatory approval, we believe this positions us to launch the consolidated dosing schedule next year. This is about simplicity, fewer infusions, same efficacy. And feedback on eliminating the day 15 infusion continues to be very positive from both patients and providers.

    若結果正向並獲得主管機關核准,我們相信這將使我們能在明年推出合併給藥時程。這關乎簡化:更少的輸注、相同的療效。而對於取消第 15 天輸注,來自患者與醫療提供者的回饋持續非常正面。

  • Now turning to our subcutaneous program. We are developing a self-administered at-home version of BRIUMVI, expected to be delivered via an auto-injector and a pen-like device. This program is designed to expand optionality and importantly, expand the number of patients we can reach. The program began with a Phase 1 dose escalation bioavailability study, evaluating subcu dosing relative to our approved IV schedule. Based on encouraging preliminary results, we advanced directly into our Phase 3 program.

    接著談我們的皮下(subcutaneous)計畫。我們正在開發可由患者在家自行施打的 BRIUMVI 版本,預計透過自動注射器與類筆式裝置給藥。此計畫旨在擴大選擇性,更重要的是擴大我們可觸及的患者數。該計畫起始於第 1 期劑量遞增生體可用率研究,評估皮下給藥相對於我們已核准的 IV 給藥時程。基於令人鼓舞的初步結果,我們直接推進至第 3 期計畫。

  • In Phase 3, we are evaluating two subcu dosing schedules, every two months and quarterly dosing with the primary endpoint being non-inferiority to IV based on drug exposure over 24 weeks. We are pleased to report in April that the study is now fully enrolled, and we expect top line data around year-end or early next year, putting us on track for a potential 2028 launch of subcu BRIUMVI, assuming a positive outcome and regulatory approval.

    在第 3 期中,我們評估兩種皮下給藥時程:每兩個月一次與每季一次;主要終點為以 24 週的藥物暴露量為基礎,證明相較 IV 的非劣性。我們很高興在 4 月宣布研究已完成全數收案,並預期在年底或明年初取得主要數據;若結果正向並獲得主管機關核准,我們將有望在 2028 年推出皮下 BRIUMVI。

  • And I know many of you have been waiting for the Phase 1 bioavailability data. We now expect to share those results in the coming weeks. Strategically, it's important to understand what subcu represents. This is not about incremental growth, and it's not about building a new infrastructure or entering a new indication.

    我知道許多人一直在等待第 1 期生體可用率數據。我們目前預期將在未來幾週分享這些結果。從策略面來看,理解皮下給藥所代表的意義很重要。這不是為了些微的增量成長,也不是為了建立新的基礎設施或進入新的適應症。

  • This is about expanding our reach within the same disease with largely the same physicians and commercial footprint, creating significant operating leverage. By enabling us to compete across both infusion and self-administered settings, we move from participating in a portion of the market to potentially participating across the entire anti-CD20 landscape.

    這是要在同一疾病領域內、面向大致相同的醫師群與商業覆蓋範圍,擴大我們的觸及,從而創造顯著的營運槓桿。透過讓我們能同時在輸注與自行施打場景中競爭,我們將從只參與部分市場,轉變為有機會參與整個抗 CD20 版圖。

  • And as a result, we believe this has the potential to nearly double our addressable market with relatively limited incremental operating expense. Beyond relapsing MS, we are expanding the reach of BRIUMVI in additional autoimmune indications.

    因此,我們相信在相對有限的新增營運費用下,這有潛力使我們的可服務市場(addressable market)幾乎倍增。除了復發型 MS 之外,我們也正在將 BRIUMVI 的觸及擴展至其他自體免疫適應症。

  • We view BRIUMVI as a pipeline within a product with a long runway supported by patent protection into the 2040s. Myasthenia Gravis, we've completed our Phase 1 work and expect to initiate a Phase 2 potentially registration-directed study this quarter. We're also initiating an exploratory study in treatment-resistant schizophrenia. There is emerging evidence suggesting an autoimmune component in a subset of these patients. It's early, but have validated the implications could be significant.

    我們將 BRIUMVI 視為「產品中的研發管線」,在專利保護支持下可延伸至 2040 年代,具備長期成長跑道。重症肌無力方面,我們已完成第 1 期工作,並預期在本季啟動第 2 期、可能以註冊為導向的研究。我們也將啟動一項針對治療抗性思覺失調症的探索性研究。越來越多證據顯示,這些患者中的一部分可能存在自體免疫成分。雖然仍在早期,但若其意涵獲得驗證,可能具有重大影響。

  • And finally, azer-cel, our allogeneic anti-CD19 CAR-T continues to advance in progressive MS. Importantly, trial sites are identifying more patients than we currently have slots available and additional sites continue to express interest in participating. This further highlights the unmet medical need in progressive MS.

    最後,azer-cel——我們的同種異體(allogeneic)抗 CD19 CAR-T——在進行性 MS 的開發持續推進。重要的是,試驗中心正在辨識出比我們目前可提供名額更多的患者,且更多中心持續表達參與意願。這進一步凸顯進行性 MS 的未被滿足醫療需求。

  • We look forward to sharing updates from this study later this year. Finally, I'd like to make a few remarks on our capital allocation. During the quarter, we expanded our relationship with Blue Owl, enhancing our financial flexibility. This gives us the ability to continue repurchasing shares and pursue strategic business development opportunities.

    我們期待在今年稍晚分享此研究的最新進展。最後,我想就資本配置做幾點說明。本季我們擴大了與 Blue Owl 的合作關係,提升了我們的財務彈性。這讓我們能夠持續回購股份,並追求策略性商業開發機會。

  • We've been clear. `We view our stock as undervalued, and we're acting on that. This quarter alone, we repurchased $100 million of our stock. At the same time, our approach to capital allocation is straightforward.

    我們已經說得很清楚:「我們認為公司股價被低估,並且正在採取行動。」僅在本季,我們就回購了 1 億美元的公司股票。同時,我們的資本配置方法很直接。

  • We will continue to deploy capital where we see the best risk-adjusted long-term return, whether that's in the business, repurchasing shares or pursuing external opportunities or investments. With that, let me turn the call over to Adam Waldman, our Chief Commercialization Officer, for more detailed commercial update. Adam, please go ahead.

    我們將持續把資本投入到我們認為具備最佳風險調整後長期報酬的地方,無論是投入業務本身、回購股份,或是追求外部機會或投資。接下來,我把電話交給我們的首席商業化長 Adam Waldman,請他提供更詳細的商業更新。Adam,請開始。

  • Adam Waldman - Chief Commercialization Officer

    Adam Waldman - Chief Commercialization Officer

  • Thanks, Mike, and good morning, everyone. I'll pick up on a few themes that Mike just laid out, particularly around consistency, durability and execution because that's exactly what we're seeing on the commercial side of the business. We delivered approximately $195 million in US net revenue in Q1, exceeding our guidance range and growing 63% year-over-year, our 12 consecutive quarter of sequential growth since launch.

    謝謝你,Mike,各位早安。我想延續 Mike 剛才提出的幾個主題,特別是關於一致性、持久性與執行力,因為這正是我們在商業端所看到的表現。我們在第一季實現約 1.95 億美元的美國淨營收,超出我們的指引區間,年增 63%,也是自上市以來連續第 12 個季度的逐季成長。

  • We saw record new patient enrollments in the quarter, and March was our highest month ever. As a result of the strong first quarter, we're raising full year US revenue guidance to $885 million to $900 million, and we're providing Q2 guidance targeting approximately $220 million in US, BRIUMVI net revenue. And importantly, we've now reached a meaningful milestone. More than 25,000 patients have been prescribed BRIUMVI globally.

    本季我們看到創紀錄的新病患入組,且 3 月是我們有史以來表現最強的一個月。受惠於第一季的強勁表現,我們將全年美國營收指引上調至 8.85 億至 9.00 億美元,並提供第二季指引,目標為約 2.20 億美元的美國 BRIUMVI 淨營收。更重要的是,我們已達成一個具意義的里程碑:全球已有超過 25,000 名病患被開立 BRIUMVI。

  • That's important because at this point, we're no longer talking about early adoption. We're talking about a growing installed base of patients being treated in the real world. At its core, this is a recurring treatment model. Patients who start BRIUMVI are typically treated every six months, and we continue to see strong persistence over time, stronger than what we originally modeled.

    這很重要,因為在此時點,我們談的已不再是早期採用,而是正在真實世界中接受治療、且持續擴大的既有病患基礎。其核心是一種經常性治療模式。開始使用 BRIUMVI 的病患通常每六個月治療一次,而我們持續看到隨時間推移的高留存率,甚至高於我們原先的模型假設。

  • That means our revenue base doesn't reset each year, it builds. Each cohort of new patients adds to an expanding base of recurring demand. As that base grows, we're developing greater visibility into underlying demand and growth becomes more predictable over time.

    這表示我們的營收基礎不會每年重置,而是持續累積。每一批新增病患都會為不斷擴大的經常性需求基礎增添動能。隨著這個基礎成長,我們對底層需求的能見度提高,成長也會隨時間變得更可預測。

  • The outperformance we saw in Q1 and the raise in guidance reflects both that growing base, including better-than-expected persistence and stronger-than-expected new patient demand. Importantly, we guide conservatively on that new patient growth layer, and we raise when the data supports it.

    第一季的超預期表現以及指引上調,反映了這個持續擴大的基礎,包括優於預期的留存率與強於預期的新病患需求。重要的是,我們對新病患成長這一層的指引一向保守,並在數據支持時才上調。

  • That combination is what's driving the business today. And as we said before, the more patients that go on BRIUMVI, the more patients will go on BRIUMVI, and we're seeing that dynamic take hold. Let me be direct about the competitive environment.

    這樣的組合正是當前推動業務的關鍵。正如我們先前所說,越多病患開始使用 BRIUMVI,就會有越多病患開始使用 BRIUMVI,而我們正看到這種動態開始成形。讓我直接談談競爭環境。

  • We compete against established products backed by large organizations, and we don't underestimate that. At the same time, in Q1, we continued to grow sequentially while outpacing both competitors and the broader MS market. We've been growing IV share consistently, and we're now the number one CD20 by dynamic share in private practices with infusion capabilities. Why is that happening? Because we're delivering on the factors that matter most to physicians, a compelling clinical profile, operational simplicity and a consistent treatment experience.

    我們與由大型組織支持的既有產品競爭,我們不會低估這一點。同時,在第一季,我們在逐季成長的同時,增速也超越兩個競品以及整體多發性硬化症(MS)市場。我們的靜脈注射(IV)市占率持續提升,且在具備輸注能力的私人診所中,我們已成為以動態市占率計算的第一大 CD20。為什麼會這樣?因為我們在醫師最重視的因素上交付成果:具吸引力的臨床特性、營運上的簡便性,以及一致的治療體驗。

  • The one-hour infusion, twice yearly dosing and long-term data all contribute to that. And when physicians put a patient on BRIUMVI and that patient has a positive outcome, that physician becomes a repeat prescriber. Since November, we've seen consistent increases in total monthly prescribers with March setting a new high. And most importantly, we're increasing uptake with treatment-naive patients, patients starting their CD20 journey on BRIUMVI, not switching to it.

    一小時輸注、每年兩次給藥以及長期數據都促成了這一點。當醫師讓病患使用 BRIUMVI 且病患獲得良好結果時,該醫師就會成為重複開立者。自 11 月以來,我們看到每月總開立醫師數持續增加,且 3 月創下新高。最重要的是,我們正在提升治療初始(treatment-naive)病患的使用率,也就是病患在其 CD20 治療旅程一開始就選擇 BRIUMVI,而不是從其他藥物轉換過來。

  • The share of naive patients in our mix continues to rise, which we view as the strongest leading indicator of long-term market position. The momentum we're seeing comes down to execution and doing a few things consistently well. We've reduced friction across the treatment journey, improving time to start and conversion rates. We've expanded our reach and deepened our presence across accounts. And our DTC efforts are helping to increase patient awareness with more patients entering the office already informed about BRIUMVI.

    在我們的組合中,初始病患的占比持續上升,我們將其視為長期市場地位最強的領先指標。我們看到的動能歸結於執行力,以及持續把幾件事做對、做穩。我們降低了整個治療旅程中的摩擦,改善啟動治療所需時間與轉換率。我們擴大觸及範圍並加深在各帳戶的存在感。我們的直接面向消費者(DTC)推廣也在提升病患認知,讓更多病患在進診間前就已了解 BRIUMVI。

  • This is exactly what we set out to build, a commercial engine that can deliver consistent execution, support long-term growth and scale over time. And importantly, we're doing this while still early in the life cycle. As Mike outlined, we have two programs that help explain why we believe the long-term opportunity is meaningfully larger than what is reflected today.

    這正是我們想打造的:一個能夠穩定執行、支持長期成長並可隨時間擴張的商業引擎。重要的是,我們仍處於產品生命週期的早期階段。正如 Mike 所概述,我們有兩個計畫可說明為何我們相信長期機會顯著大於目前所反映的水準。

  • First, ENHANCE. This is about simplifying the initiation process by eliminating the day 15 infusion. If successful, we would expect it to enhance operational efficiency and make it easier for physicians and infusion centers to get patients started on BRIUMVI. We view this as an incremental improvement to an already strong IV offering, one that can further support adoption.

    第一個是 ENHANCE。其目標是透過取消第 15 天輸注來簡化起始流程。若成功,我們預期可提升營運效率,並讓醫師與輸注中心更容易讓病患開始使用 BRIUMVI。我們將其視為對既有強勢 IV 方案的增量改進,可進一步支持採用。

  • Second, our subcutaneous patient administered formulation. This is a much more significant strategic opportunity. Today, the subcutaneous patient-administered segment represents roughly 35% of the anti-CD20 market, a segment we are not participating in today. So this is not about taking share within our existing IV business. This is about opening up a new segment of the market.

    第二個是我們的皮下(subcutaneous)病患自我給藥劑型。這是一個更重大的策略性機會。目前,皮下病患自我給藥的區隔約占整體抗 CD20 市場的 35%,而我們目前尚未參與這個區隔。因此,這不是在我們既有 IV 業務內搶市占,而是要開啟市場中的一個新區隔。

  • If successful, subcu BRIUMVI would allow us to reach patients who prefer or require at-home self-administration, compete directly in a large and growing segment of the market and meaningfully expand the overall addressable opportunity. And when you look at this holistically, IV plus subcu is not just incremental expansion.

    若成功,皮下 BRIUMVI 將使我們能觸及偏好或需要在家自我給藥的病患,直接在一個龐大且成長中的市場區隔中競爭,並顯著擴大整體可服務市場機會。從整體來看,IV 加上皮下並不只是增量擴張。

  • It has the potential to redefine the scale of the BRIUMVI franchise over time. Importantly, the current business is already performing at a high level. We don't need these programs to deliver on our near-term expectations. But over time, they have the potential to meaningfully expand both the reach and long-term value of BRIUMVI. So to summarize, we've outperformed expectations in Q1, driven by strong underlying demand.

    它有潛力隨時間重新定義 BRIUMVI 產品線的規模。重要的是,現有業務已在高水準運作。我們不需要這些計畫來達成短期預期;但隨時間推移,它們有潛力顯著擴大 BRIUMVI 的觸及範圍與長期價值。總結而言,我們在第一季表現超出預期,主要由強勁的底層需求所驅動。

  • We're seeing continued expansion in both patients and prescribers. Our execution is translating into durable, increasingly predictable growth, and we're significantly raising our 2026 outlook. We now have over 25,000 patients globally, and that base continues to grow.

    我們看到病患數與開立者數持續擴張。我們的執行正轉化為具持久性、且愈來愈可預測的成長,並且我們大幅上調 2026 年展望。目前全球已有超過 25,000 名病患,而這個基礎仍在持續成長。

  • We're approaching a $1 billion annualized run rate, supported by a model that is becoming more scalable over time. And with IV and subcu, we're building a franchise that has the potential to compete across the full spectrum of the anti-CD20 market.

    我們正接近年化約 10 億美元的運行率(run rate),並由一個隨時間愈發可擴展的模式所支撐。透過 IV 與皮下兩種形式,我們正在打造一個有潛力在抗 CD20 市場全光譜競爭的產品線。

  • When you consider the size of the IV market, the portion we'll be able to access with subcutaneous and the trajectory we're seeing today, we believe the long-term opportunity for BRIUMVI is well above where consensus peak estimate sales sit today and ultimately more consistent with the leading assets in the category. Let me now turn the call over to Sean Power, our CFO, for a detailed financial update.

    當你考量 IV 市場的規模、我們透過皮下可觸及的部分,以及我們目前看到的成長軌跡,我們相信 BRIUMVI 的長期機會遠高於目前市場共識的峰值銷售預估,並最終更接近該類別中的領先資產。接下來我把電話交給我們的財務長 Sean Power,進行更詳細的財務更新。

  • Sean Power - Chief Financial Officer, Treasurer, Corporate Secretary

    Sean Power - Chief Financial Officer, Treasurer, Corporate Secretary

  • Thanks, Adam. A few things to highlight on the financial side. As Mike and Adam highlighted, we came in ahead of expectations. US net product revenue in Q1 was approximately $195 million, up 63% versus the same quarter last year.

    謝謝你,Adam。我先強調幾個財務面重點。如 Mike 與 Adam 所提到,我們的表現優於預期。第一季美國淨產品營收約為 1.95 億美元,較去年同期成長 63%。

  • Total net product revenue was $201 million when including product sales to Neuroxpharm, our ex-US partner. Add in $3.6 million of license, royalty and other revenue and total revenue for the quarter was $205 million on the expense side, OpEx, which we define as R&D and SG&A, excluding stock-based comp, was approximately $117 million for the quarter. That year-over-year increase reflects continued investment across the business.

    若包含對 Neuroxpharm(我們的美國以外合作夥伴)的產品銷售,總淨產品營收為 2.01 億美元。再加上 360 萬美元的授權、權利金及其他收入,本季總營收為 2.05 億美元。費用面方面,我們所定義的營運費用(OpEx)為研發(R&D)與銷售、一般及行政(SG&A),不含股票基礎薪酬,本季約為 1.17 億美元。年增主要反映我們持續在各業務面向投入。

  • On the R&D side, a milestone expense under our Precision Biosciences agreement and higher clinical costs, partially offset by lower subcutaneous manufacturing and development spend. And on the SG&A side, expanded marketing and media investment supporting BRIUMVI's continued growth. Even with that investment, revenue growth continues to outpace expense growth, and that dynamic drove operating income of $34.8 million compared to $8.6 million in Q1 of last year.

    研發方面,包含我們與 Precision Biosciences 協議下的一筆里程碑費用,以及較高的臨床成本,部分被較低的皮下製造與開發支出所抵銷。SG&A 方面,則是擴大行銷與媒體投資,以支持 BRIUMVI 的持續成長。即便有這些投資,營收成長仍持續快於費用成長,而這一動態使營業利益達到 3,480 萬美元,相較去年第一季的 860 萬美元。

  • One item worth flagging below the operating line was a onetime $9.2 million charge related to the refinancing of our Blue Owl facility, of which approximately 50% was noncash. All that net income for the quarter of $19.8 million or $0.12 per diluted share compared to $5.1 million or $0.03 per diluted share a year ago.

    在營業利益以下有一項值得提醒的項目:與我們 Blue Owl 融資安排再融資相關的一次性 920 萬美元費用,其中約 50% 為非現金。綜合以上,本季淨利為 1,980 萬美元,或稀釋後每股 0.12 美元,相較一年前為 510 萬美元,或稀釋後每股 0.03 美元。

  • On the balance sheet, we ended the quarter with approximately $573 million in cash, cash equivalents and investment securities, up from roughly $200 million at year-end, reflecting primarily the proceeds from the expanded Blue Owl facility. From a capital allocation standpoint, we repurchased over 3 million shares during the quarter at an average price of roughly $30.

    資產負債表方面,我們在季末持有約 5.73 億美元的現金、約當現金與投資證券,高於年末約 2.00 億美元,主要反映擴增後的 Blue Owl 融資安排所帶來的資金進帳。就資本配置而言,我們在本季以約 30 美元的平均價格回購超過 300 萬股。

  • Since launching the program, we bought back approximately 6.8 million shares at an average price of approximately $29, nearly 5% of shares outstanding, leaving us with 153 million shares outstanding today. Turning to guidance. We're raising our full year total global revenue guidance to approximately $925 million.

    自該計畫啟動以來,我們已以約 29 美元的平均價格回購約 680 萬股,約占流通在外股份的 5%,使我們目前流通在外股份為 1.53 億股。接著談指引。我們將全年全球總營收指引上調至約 9.25 億美元。

  • On expenses, we continue to expect full year operating costs of approximately $350 million, excluding stock-based comp, plus approximately $100 million for subcutaneous manufacturing and secondary manufacturer start-up activities. As we've noted previously, those manufacturing costs are expensed through R&D as incurred.

    在費用方面,我們仍預期全年營運成本約為 3.5 億美元(不含以股份為基礎的薪酬),另加約 1 億美元用於皮下製造以及第二製造商啟動活動。正如我們先前所提,這些製造成本在發生時會透過研發費用認列。

  • So if the programs are successful, the related inventory would be sold in future periods with little to no associated cost of goods. All in all, it was a strong quarter. Revenue ahead of expectations, operating income up meaningfully year-over-year and a balance sheet that gives us real flexibility going forward.

    因此,若這些計畫成功,相關庫存將在未來期間出售,且幾乎不會有相應的銷貨成本。總體而言,這是一個強勁的季度。營收優於預期,營業利益較去年同期顯著成長,且資產負債表讓我們在未來具備真正的彈性。

  • With that, I'll turn the call back over to the conference operator to begin the Q&A.

    接下來,我將把電話交回給會議主持人,開始問答環節。

  • Operator

    Operator

  • (Operator instructions)

    (主持人指示)

  • Corinne Johnson, Goldman Sachs.

    Corinne Johnson,高盛。

  • Corinne Johnson - Analyst

    Corinne Johnson - Analyst

  • Thanks, and good morning, guys. Maybe could you just speak to the market opportunity for the subcutaneous product? If you're able to bring a 12-week versus eight-week formulation to the market, do you see that as going to meaningfully different in terms of your ability to gain share in that currently untapped population?

    謝謝,大家早安。或許你們能談談皮下產品的市場機會?如果你們能把 12 週、而非 8 週的劑型推向市場,你們是否認為這會在你們於目前尚未觸及的人群中取得市占方面,帶來顯著不同的能力?

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Sure. Adam, do you want to tackle that one?

    當然。Adam,你要回答這題嗎?

  • Adam Waldman - Chief Commercialization Officer

    Adam Waldman - Chief Commercialization Officer

  • Sure. Yes. Thanks for the question, Corinne. As we mentioned that segment represents about 35% of the CD20 market today. One, we do not compete in and our perspective is this is expanding into a new patient population rather than shifting patients within our existing base. We think of these as largely distinct segments with different patients and physician preferences. And importantly, I think, as Mike mentioned, puts us in position to compete across both the IV and subcu space across the entire CD20 landscape.

    好的。是的。謝謝你的問題,Corinne。如我們提到的,該細分市場目前約占 CD20 市場的 35%。第一,我們目前並未在該領域競爭;我們的觀點是,這是在擴展到新的病患族群,而不是在既有基礎內移轉病患。我們認為這些大多是不同的細分市場,病患與醫師偏好也不同。更重要的是,我想如 Mike 所提,這讓我們有能力在整個 CD20 版圖中,同時在靜脈注射(IV)與皮下(subcu)領域競爭。

  • We think that Q3 -- to your question about dosing -- we think Q3 obviously would be better than incrementally better. I think both are going to be great. But I think we subscribe to less is more. But I think both would be a very strong profile, and we feel good about the opportunity for both whichever way it works out.

    至於你問到的給藥間隔,我們認為 Q3(每季一次)顯然會比僅僅小幅改善更好。我覺得兩者都會很棒,但我們相信「越少越好」。不過我認為兩種方案都會是非常強的產品特徵,我們對兩者的機會都很有信心,最終取決於結果如何。

  • Operator

    Operator

  • Brian Cheng, JPMorgan.

    Brian Cheng,摩根大通。

  • Brian Cheng - Analyst

    Brian Cheng - Analyst

  • Hey, guys. Thanks for taking our questions this morning. Just first, can you talk a little bit about the cadence of data from the ENHANCE trial and the Phase 1 bioavailability data? In your prepared remarks, you said both data will be coming in the coming weeks. So which one should we expect first? Are both data coming at the same time? And I have a follow-up. Thank you.

    嗨,各位。謝謝今天早上回答我們的問題。首先,你們能談談 ENHANCE 試驗數據與第一期生體可用率數據的發布節奏嗎?在你們的準備講稿中提到,兩項數據都會在接下來幾週出爐。那我們應該先期待哪一項?兩項會同時出來嗎?我還有一個追問。謝謝。

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Yeah, in terms of timing, we don't have the exact timing. We just know that things are coming in soon. So we just basically thought we'd let people know that, that data was coming.

    是的,就時間點而言,我們沒有確切的時程。我們只知道很快就會出來。所以我們基本上只是想讓大家知道,數據即將公布。

  • Brian Cheng - Analyst

    Brian Cheng - Analyst

  • Earlier during you talked about the dynamics of persistence, and you talked about how persistence is stronger than you have anticipated. Can you provide a little bit more color to that? And how much does the DTC campaign so far in driving patients coming to physician practice and asking for BRIUMVI?

    先前你談到治療持續性(persistence)的動態,並提到持續性比你們預期更強。你能再多補充一些細節嗎?另外,目前 DTC(直接面向消費者)宣傳活動在推動病患到診所並主動詢問 BRIUMVI 方面,影響有多大?

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Thanks for the question, Brian. Adam, do you want to tackle this one?

    謝謝你的問題,Brian。Adam,你要回答這題嗎?

  • Adam Waldman - Chief Commercialization Officer

    Adam Waldman - Chief Commercialization Officer

  • Sure. I mean on the persistent side, obviously, we're encouraged, given my remarks, we're encouraged by what we're seeing on the persistence, particularly as patients move into the second year of treatment where trends have been better than expected. And we think these patterns that we're seeing are supportive of the durability of the patient experience, which obviously reflects the tolerability and efficacy of BRIUMVI. That said, still early, and we will continue to monitor it, but we're growing in confidence as we continue to build as the data matures. And it comes down to sustainability of efficacy and tolerability.

    當然。就持續性而言,顯然如我剛才所說,我們對目前看到的持續性表現感到鼓舞,特別是當病患進入治療第二年時,趨勢優於預期。我們認為這些模式支持病患體驗的持久性,而這顯然反映了 BRIUMVI 的耐受性與療效。不過目前仍屬早期,我們會持續追蹤;隨著數據成熟、累積更多資料,我們的信心也在提升。歸根結底在於療效與耐受性的可持續性。

  • And then generally, when patients do well, they stay on therapy and that drives persistence. As far as DTC, we're encouraged. We've been putting effort into DTC over the last year or so. We've been encouraged with the markers and indicators of success. We'll continue to invest in the space. We think this is a patient driven.

    一般而言,當病患治療效果好,就會持續用藥,這會帶動持續性。至於 DTC,我們感到鼓舞。過去一年左右我們在 DTC 上投入了不少努力,從成功的各項指標與訊號來看,我們受到鼓舞。我們會持續在這個領域投資。我們認為這是由病患驅動的。

  • They do have shared decision-making in this market. And so we're going to continue to focus on it, and we are encouraged by what we're seeing so far.

    在這個市場中,病患確實會參與共同決策。因此我們會持續聚焦於此,而且就目前所見,我們感到鼓舞。

  • Operator

    Operator

  • Tara Bancroft, TD Cowen.

    Tara Bancroft,TD Cowen。

  • Tara Bancroft - Analyst

    Tara Bancroft - Analyst

  • Hi. Congrats on the quarter, and thanks for taking my question. This is Greg on for Tara. So you reiterated top line Phase 3 data for the subcu BRIUMVI around year-end 2026 or early next year. Can you provide any additional color on the cadence from data readout to filing? And how quickly the subcu formulation become commercially available, assuming a favorable outcome?

    嗨。恭喜本季表現,也謝謝讓我提問。我是代 Tara 發問的 Greg。你們重申皮下 BRIUMVI 的第三期頂線數據將在 2026 年底或明年初公布。你們能否就從數據讀出到申報之間的節奏提供更多說明?另外,在結果有利的前提下,皮下劑型多快能夠商業化上市?

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Sure. So our target is to have the subcu available sometime in 2028. In terms of the cadence of filing after the completion of that study, our goal is to get that filed as soon as we can. We've got a few other studies we'll need to do in the interim to get the filing package complete, including the bridge to the auto-injector. But yes, I mean, for '28, as soon as early as possible, '27, we're going to get that filing done.

    好的。我們的目標是在 2028 年某個時間點讓皮下劑型上市。至於該研究完成後的申報節奏,我們的目標是盡快完成申報。我們在此期間還需要做幾項其他研究,才能把申報資料包補齊,包括與自動注射器(auto-injector)的橋接研究。不過是的,為了 2028 年,我們會盡可能早地在 2027 年完成申報。

  • That's the goal for '28 approval. Again, it's -- the one thing we can't control is the -- about a 12-month review process. So that's the timing of that. Was there a last part of that question, I'm sorry. No, that covers my question.

    目標是 2028 年獲批。再次強調——我們唯一無法控制的是大約 12 個月的審查流程,這就是時間點。你剛才問題最後一部分是什麼,不好意思。沒有的話,那就涵蓋了。

  • Tara Bancroft - Analyst

    Tara Bancroft - Analyst

  • No, that covers my question. Thank you.

    沒有了,已經回答我的問題。謝謝。

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Roger Song, Jefferies.

    Roger Song,Jefferies。

  • Roger Song - Equity Analyst

    Roger Song - Equity Analyst

  • Hi, this is Chucky Yang on for Roger. Thanks for taking my question. So I was wondering if you could speak to what you think the impact of remibrutinib's potential approval in MS would be on BRIUMVI, but also on the CD20 class as a whole?

    嗨,我是代 Roger 發問的 Chucky Yang。謝謝讓我提問。我想請教,你們認為 remibrutinib 若在多發性硬化症(MS)獲得潛在核准,對 BRIUMVI 以及對整個 CD20 類別會有什麼影響?

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Yeah, thanks for the question. So we continue to await product profiles for all the BTKs as they've come through the clinical trials. Each one in turn has had some difficulties, I would say, in producing data that is convincing of a clinical benefit over risk. We'll see how fenebrutinib does at the agency and remibrutinib is yet to come.

    是的,謝謝你的問題。我們仍在等待所有 BTK 藥物在臨床試驗中逐步揭露的產品特徵。就目前來看,我會說每一個在產出能令人信服、且臨床效益大於風險的數據方面,都遇到了一些困難。我們會看看 fenebrutinib 在主管機關那邊的表現,而 remibrutinib 還要再等等。

  • So I think we just have to wait. I mean, overall, we've maintained our position that there's certainly a home for these drugs in certain patient populations, particularly patients who are potentially secondary -- nonactive secondary progressive where we're not labeled.

    所以我認為我們只能等待。整體而言,我們維持一貫立場:這些藥物在某些病患族群中確實有其定位,特別是可能屬於次發性——非活動性次發進行型(nonactive secondary progressive)的病患,而我們目前並未取得該適應症標示。

  • So I think there's room for -- remember, there's still a big oral market. I think there's room for a BTK with the right profile to participate in that oral marketplace. But we don't think it's a drug class that will have a material impact on the CD20 class.

    因此我認為仍有空間——請記得,口服市場仍然很大。我認為具備合適產品特徵的 BTK,有機會參與那個口服市場。但我們不認為這個藥物類別會對 CD20 類別造成實質性的影響。

  • Operator

    Operator

  • Michael DiFiore, Evercore ISI.

    Michael DiFiore,Evercore ISI。

  • Michael DiFiore - Analyst

    Michael DiFiore - Analyst

  • Hi, guys. Thanks so much for taking my questions. Just one for me. Just given Roche's potential twice yearly home OCREVUS device and KESIMPTA's longer interval work, what dosing profile does subcu guy need to have in order to be meaningfully differentiated? Is every two-month dosing enough? Or is quarterly dosing really the commercial bar given where we're headed? Thank you.

    嗨,各位。非常感謝回答我的問題。我只有一題。考量 Roche 可能推出一年兩次、可在家使用的 OCREVUS 裝置,以及 KESIMPTA 正在研究更長給藥間隔,你們認為皮下產品需要什麼樣的給藥特徵,才能形成有意義的差異化?每兩個月一次的給藥夠嗎?還是以我們未來的趨勢來看,每季一次才是商業上的門檻?謝謝。

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Sure. Thanks for the question, Michael. Look, as Adam mentioned, it's a competitive market. Everyone is trying to do their best to improve their product profile to meet the needs and challenges that these individuals with MS face, and we're certainly doing our part. Obviously, we've said before, we feel that -- and Adam said it earlier, the market is large.

    好的,謝謝你的問題,Michael。正如 Adam 提到的,這是一個競爭激烈的市場。每家公司都在盡力改善其產品特徵,以滿足 MS 病患所面臨的需求與挑戰,我們當然也在盡我們的努力。顯然,我們之前也說過,我們認為——而 Adam 先前也提到——市場規模很大。

  • It can probably get larger on the subcu side. We'll continue to obviously have a very big presence in the IV sector, whereas I don't think the other -- I don't think OCREVUS' long-term plan is to participate much longer in the IV marketplace. And as you mentioned, they're working on their own at-home on-body device. So like I said, from the standpoint of the patient, this is all great.

    在皮下端,市場規模可能還會更大。我們顯然會持續在 IV 領域維持非常大的存在感;而我不認為其他——我不認為 OCREVUS 的長期計畫會繼續在 IV 市場參與太久。正如你提到的,他們正在開發自家的居家穿戴式(on-body)裝置。所以如我所說,從病患角度來看,這些都是好事。

  • And as Adam mentioned earlier, every two months or every three months will be a really strong offering. Again, it's BRIUMVI still loaded into the auto-injector, which means that all the differentiation that we have on the IV side, on the molecule itself will continue to exist as we go into the marketing effort on the subcu side. So convenience is one thing. Obviously, as Adam said, quarterly is going to be incrementally better than every other month.

    正如 Adam 先前提到的,每兩個月或每三個月一次都會是非常有力的給藥方案。再次強調,仍然是將 BRIUMVI 裝載於自動注射器中,這意味著我們在靜脈注射(IV)端、以及分子本身所具備的所有差異化優勢,在我們推進皮下(subcu)端的行銷工作時仍將持續存在。因此,便利性是一個因素。顯然,如 Adam 所說,按季(每季一次)會比隔月一次在便利性上更進一步。

  • We feel obviously very confident in our ability to deliver a quarterly product, but I think we'll let the data speak for itself as it solely comes out. But yes, I think we're going to do great. I mean we've done quite well in the IV space. Again, BRIUMVI is a molecule and the convenience factors all come together. So I think it's a package of competitive products and ours is going to be, I think, highly competitive in this marketplace and like I said, we think we're going to do really, really well in this space.

    我們對於交付一個按季產品的能力顯然非常有信心,但我想我們會讓數據在逐步釋出時自行說明。不過是的,我認為我們會做得很好。我們在 IV 領域的表現一直相當不錯。再次強調,BRIUMVI 是一個分子,而便利性因素也都匯聚在一起。因此我認為這是一套具競爭力的產品組合,而我們的產品在這個市場中將會非常有競爭力;如我所說,我們認為我們會在這個領域表現得非常、非常好。

  • Operator

    Operator

  • Emily Bodnar, H.C. Wainwright.

    Emily Bodnar,H.C. Wainwright。

  • Emily Bodnar - Equity Analyst

    Emily Bodnar - Equity Analyst

  • Thanks for seeing the questions. Maybe one on the updated guidance. Obviously, quite an uptick from the fourth quarter guidance. So maybe just talk a bit more on your confidence for why you think the growth you saw in Q1 might be sustained for the rest of the year? And also on operating expenses, it looks like that was up quite a bit in the first quarter. So maybe just touch on expectations.

    謝謝讓我提問。想問一個關於更新後的財測指引。顯然,相較於第四季的指引有相當大的上修。能否再多談談你們為何有信心認為第一季看到的成長可以在今年剩餘時間持續?另外關於營運費用,第一季看起來上升不少。也請談談你們的預期。

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Sure. Adam, do you want to start on the updated guidance?

    好的。Adam,你要先談更新後的指引嗎?

  • Adam Waldman - Chief Commercialization Officer

    Adam Waldman - Chief Commercialization Officer

  • Yeah, sure. Thanks for the question, Emily. Q1 performance, as I mentioned, was driven by strength across all key drivers, including record number of new patient starts and better-than-expected persistence. I think we're seeing that momentum continue into Q2. And as I outlined in my prepared remarks, the model really has two components to it.

    好,當然。謝謝你的問題,Emily。第一季的表現,如我提到的,是由所有關鍵驅動因素的強勁表現所帶動,包括創紀錄的新病患啟動數,以及優於預期的治療持續性。我認為我們看到這股動能延續到第二季。正如我在事先準備的發言中所概述的,模型其實有兩個組成部分。

  • It's a growing recurring base with continued new patient demand. And so the strength of Q1 reflects both of these working together and gives us confidence in the updated full year guidance.

    一個是持續成長的經常性基礎(recurring base),另一個是持續的新病患需求。因此,第一季的強勁反映了這兩者共同作用,也讓我們對更新後的全年指引更有信心。

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Sean, do you want to talk about the OpEx?

    Sean,你要談談營運費用(OpEx)嗎?

  • Sean Power - Chief Financial Officer, Treasurer, Corporate Secretary

    Sean Power - Chief Financial Officer, Treasurer, Corporate Secretary

  • Thanks, Emily. Yes, on the OpEx front, as we said in our prepared remarks, we expect full year OpEx, again, which we define as R&D and SG&A, excluding stock-based comp, to be roughly $350 million, plus an additional $100 million for subcutaneous manufacturing work and secondary manufacturer preparation. So yes, Q1 was up a little bit higher than perhaps that range would guide, but we are still reiterating that guidance for the full year.

    謝謝,Emily。是的,關於 OpEx,如我們在事先準備的發言中所說,我們預期全年 OpEx——我們將其定義為研發(R&D)與銷售、一般及行政費用(SG&A),不含以股票為基礎的薪酬——約為 3.5 億美元,另外再加上約 1 億美元用於皮下製造工作以及第二供應商的準備。因此,是的,第一季可能比該區間所暗示的水準略高一些,但我們仍重申全年指引不變。

  • Operator

    Operator

  • Prakhar Agrawal, Cantor Fitzgerald.

    Prakhar Agrawal,Cantor Fitzgerald。

  • Prakhar Agrawal - Analyst

    Prakhar Agrawal - Analyst

  • Hi, This is Jennifer on behalf of Cantor. Congrats on the quarter. I have two quick questions. One on the capital allocation and share buyback versus meaningful BD. Since you have quite a lot of cash. What's the plan on that? And then quickly on the gross to net discount for Q1, how do you expect that for the rest of the year?

    嗨,我是 Jennifer,代表 Cantor。恭喜本季表現。我有兩個簡短問題。第一個關於資本配置與庫藏股回購相較於有意義的商務開發(BD)。你們手上現金很多,這方面的計畫是什麼?第二個快速問一下,第一季的毛額到淨額(gross-to-net)折扣,預期今年剩餘時間會如何?

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Sure. Adam, why don't you or Sean handle the gross to net, and I'll talk about the use of cash.

    好的。Adam 或 Sean,你們來回答毛額到淨額(gross-to-net)的部分,我來談現金的運用。

  • Adam Waldman - Chief Commercialization Officer

    Adam Waldman - Chief Commercialization Officer

  • Sure, yes. As I mentioned in the Q4 call, we did have gross to net dynamics in Q1, but these were largely in line with our expectations. As I've mentioned before, gross to net can vary from quarter-to-quarter. But for the year, we expect it to average out around 65%.

    好的,是的。如我在第四季電話會議中提到的,我們在第一季確實有 gross-to-net 的動態變化,但大致符合我們的預期。正如我之前提過,gross-to-net 可能會在各季之間波動。但就全年而言,我們預期平均大約落在 65% 左右。

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • And then in terms of use of cash and capital allocation and share buybacks versus BD. Look, we continue to be highly selective in our BD efforts. We've seen some interesting things. We like some stuff. We're disciplined about what we're willing to pay for programs and assets.

    接著談現金運用、資本配置,以及庫藏股回購相較於 BD。你看,我們在 BD 的推進上仍然非常審慎挑選。我們看到一些有趣的機會,也喜歡其中一些項目。我們對於願意為計畫與資產支付的價格保持紀律。

  • And of course, we're always happy to buy our shares if others are not willing to value them at fair value. So we'll continue to buy back shares. I think that's -- until we see some significant price reassessment, we'll continue to be buying shares back with our cash. And like I said, yes, we're out there looking at new opportunities quite aggressively. And like I said, we've been disciplined about executing and certainly disciplined about price.

    當然,如果市場其他人不願意以合理價值來評價我們的股票,我們也一直樂於回購自家股票。因此我們會持續進行庫藏股回購。我認為——在我們看到股價出現顯著的重新評價之前——我們會繼續用現金回購股票。並且如我所說,是的,我們也在市場上相當積極地尋找新機會;同時也如我所說,我們在執行上保持紀律,尤其在價格上更是如此。

  • Operator

    Operator

  • William Wood, B. Riley Securities.

    William Wood,B. Riley Securities。

  • William Wood - Analyst

    William Wood - Analyst

  • Hi. Yes. Thanks for taking that question. Just thinking about in terms of sort of apart from BRIUMVI, you've got the earlier stage Azer-cel running in your open-label in PPMS. I'm just curious with that trial readout coming up later this year, if there's anything that you could sort of provide at a top level on what you might be seeing, what gives you confidence with advancing that? And then any -- yeah, I'll stop there.

    嗨,是的,謝謝讓我提問。從 BRIUMVI 以外的角度來看,你們還有較早期的 Azer-cel,在 PPMS 的開放標籤試驗中進行。我想請教,隨著該試驗的讀出將在今年稍晚公布,你們是否能在高層次上分享一下目前可能看到的情況、以及是什麼讓你們有信心推進它?然後——是的,我先問到這裡。

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Thanks. Appreciate it. Yeah, for Azer-cel, it's still early. We are excited to be moving up in the dose escalation, but it's a challenging study logistically to get to a point where we can open up enrollment. So we'll continue to push forward. I think we're just about on the pen ultimate dose.

    謝謝,感謝你的提問。是的,關於 Azer-cel,目前仍屬早期。我們很興奮能在劑量遞增上持續往上推進,但在後勤與執行上,這是一項相當具挑戰性的研究,要到能夠開放收案(enrollment)的階段需要一些時間。因此我們會持續推進。我想我們差不多到了倒數第二個劑量。

  • I think we'll be able to start that in the next one to two weeks. So we're getting close. We're getting warm, but there's a significant delay between each individual patient while we strive to get to the dose that we're targeting. Safety, of course, is going to be the most important piece. Secondarily, of course, there's going to be some biomarkers of activity, whether we're deleting B cells, oligoclonal bands in the CNS.

    我想我們在接下來一到兩週內就能開始下一個劑量,所以我們已經很接近、也逐漸進入狀態了,但在我們努力達到目標劑量的過程中,每位個別病患之間都會有顯著的時間延遲。安全性當然會是最重要的部分。其次,當然也會有一些活性生物標記(biomarkers),例如我們是否在刪除 B 細胞、以及中樞神經系統(CNS)中的寡克隆帶(oligoclonal bands)。

  • So we are hopeful to be able to present some of that data. But again, it's still early, but we're enthusiastic about it. We think the -- again, the rationale for these drugs has not subsided, and we do think that there's a real opportunity, but it's still early.

    因此我們希望能夠呈現其中一些數據。但再次強調,仍然很早期,不過我們對此感到振奮。我們認為——再次強調——這些藥物的科學理據並未減弱,我們確實認為存在真正的機會,但目前仍屬早期階段。

  • Operator

    Operator

  • I would like to turn the floor over to Michael Weiss for closing remarks.

    我想把時間交給 Michael Weiss 做結語。

  • Michael Weiss - Chairman of the Board, President, Chief Executive Officer

    Michael Weiss - Chairman of the Board, President, Chief Executive Officer

  • Great. Thank you, operator, and thanks again, everyone, for joining us this morning. Let me just briefly recap. We outperformed expectations commercially with strong revenue and record patient starts. We advanced two key life cycle programs, both with the near-term catalysts. We're expanding development efforts beyond MS into new indications, and we are allocating capital with discipline and intent. We've said this before, and it's worth repeating, we do not see BRIUMVI simply as a successful product.

    很好。謝謝接線員,也再次感謝各位今天早上加入我們。我簡要回顧一下。我們在商業表現上超出預期,營收強勁且病患啟動數創新高。我們推進了兩個關鍵的產品生命週期計畫,且兩者在短期內都有催化劑。我們正將開發工作從 MS 擴展到新的適應症,同時以紀律與明確目的進行資本配置。我們以前說過,值得再重申一次:我們不把 BRIUMVI 只視為一個成功的產品。

  • We see it as a multibillion-dollar franchise with a long runway, supported by patent protection into the 2040s and importantly, even as we approach $1 billion run rate, we believe we're still early in realizing that full potential. We remain focused on executing the business and maximizing long-term value.

    我們將其視為一個具備長期成長跑道的數十億美元級特許經營(franchise),在專利保護支持下可延伸至 2040 年代。更重要的是,即便我們接近 10 億美元的年化營收速度(run rate),我們仍相信距離完全實現其全部潛力還在早期。我們將持續專注於業務執行並最大化長期價值。

  • I want to thank our shareholders for their continued support, our TG team for their commitment to our mission and the patients we serve and of course, to the patients and health care providers for their trust in us. We take that responsibility very seriously. Thank you all again for joining us and have a great day.

    我要感謝股東們持續的支持,感謝我們 TG 團隊對使命與所服務病患的投入,當然也要感謝病患與醫療照護提供者對我們的信任。我們非常嚴肅地看待這份責任。再次感謝各位的參與,祝各位有美好的一天。

  • Operator

    Operator

  • This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.

    今天的電話會議到此結束。您現在可以掛線,感謝您的參與。