TG Therapeutics Inc (TGTX) 2023 Q4 法說會逐字稿

Greetings, and welcome to the TG Therapeutics Fourth Quarter and Year-End 2023 Financial Results and Business Update Call. (Operator Instructions). As a reminder, this conference is being recorded.

您好，歡迎參加 TG Therapeutics 2023 年第四季和年底財務業績和業務更新電話會議。（操作員說明）。提醒一下，本次會議正在錄製中。

It is now my pleasure to introduce your host, Jenna Bosco. Thank you. Please go ahead.

現在我很高興向大家介紹你們的主持人珍娜‧博斯科 (Jenna Bosco)。謝謝。請繼續。

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the fourth quarter and year-end 2023 financial results are Michael Weiss, our Chairman and Chief Executive Officer; Adam Waldman, our Chief Commercialization Officer; and Sean Power, our Chief Financial Officer.

謝謝。歡迎大家，感謝您今天早上加入我們。我是 Jenna Bosco，今天與我一起討論第四季和 2023 年年底財務表現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。

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.

在我們的安全港聲明之後，麥克將概述我們最近的公司發展，亞當將分享我們商業化工作的最新情況，肖恩將概述我們的財務業績，然後將電話轉交給運營商開始問答環節。

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 milestones, revenue guidance, development plans and expectations for our marketed products. 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 filing. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any later date. We specifically disclaim any obligation to update or revise any forward-looking statement.

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績效的陳述，包括銷售業績、預期監管里程碑、收入指導、開發計劃和對我們銷售產品的預期。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在 SEC 備案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。我們特別聲明不承擔更新或修改任何前瞻性聲明的義務。

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.

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。

Now, I'd like to turn the call over to Mike Weiss, our CEO.

現在，我想將電話轉給我們的執行長 Mike Weiss。

Thanks, Jenna, and good morning, everyone. Thanks for joining us on today's call. 2023 was a transformational year for TG. We kicked off the year with the launch of BRIUMVI for relapsing forms of multiple sclerosis toward the end of January and saw a nice sales momentum carried throughout the year, resulting in approximately $90 million in US BRIUMVI net revenue for our first partial year of sales.

謝謝，珍娜，大家早安。感謝您參加今天的電話會議。 2023 年對 TG 來說是轉型的一年。我們在1 月底推出了用於治療復發型多發性硬化症的BRIUMVI，拉開了新的一年的序幕，並看到全年的良好銷售勢頭，導致我們第一部分銷售年度的美國BRIUMVI 淨收入約為9000 萬美元。

We believe these first-year revenues speak to the high level of early interest and strong underlying demand for BRIUMVI, and we look forward to continued carry-through in 2024, where we are targeting $220 million to $260 million in US sales revenue. The feedback from physicians, patients, nurses and infusion centers continues to be very positive, and drives our confidence in both the short-term revenue ramp, as well as the long-term blockbuster potential of BRIUMVI. Our team remains focused on our ultimate goal of becoming the number one prescribed CD20 by dynamic market share perspective, and the early uptake supports our belief that that is possible.

我們相信，這些第一年的收入說明了人們對BRIUMVI 的高水平早期興趣和強勁的潛在需求，我們期待在2024 年繼續實現這一目標，我們的目標是美國銷售收入達到2.2 億至2.6 億美元。來自醫生、患者、護士和輸液中心的回饋仍然非常積極，這增強了我們對 BRIUMVI 的短期收入增長以及長期重磅炸彈潛力的信心。我們的團隊仍然專注於我們的最終目標，即從動態市場份額的角度成為排名第一的處方 CD20，早期的採用支持了我們的信念，即這是可能的。

Having said that, this is a competitive market and BRIUMVI is the newest entry, so differentiation matters. One obvious difference is that BRIUMVI is the only anti-CD20 monoclonal antibody that can be given as a one-hour infusion every six months after the starting dose, which may be an attractive profile for both patients who want to get back to their daily lives and for healthcare practices seeking to increase the efficiency within their infusion suites. Beyond the one-hour infusion, we are excited to continue to explore biological-based differences that may not be as readily apparent, but are perhaps clinically relevant.

話雖如此，這是一個競爭激烈的市場，而 BRIUMVI 是最新的進入者，因此差異化很重要。一個明顯的區別是，BRIUMVI 是唯一一種可以在起始劑量後每六個月輸註一小時的抗CD20 單株抗體，這對於想要恢復日常生活的患者來說可能是一個有吸引力的配置以及尋求提高輸液套件效率的醫療保健實踐。除了一小時的輸注之外，我們很高興繼續探索基於生物學的差異，這些差異可能不那麼明顯，但可能與臨床相關。

As a reminder, BRIUMVI is differentiated by design, having been glycoengineered for enhanced immune effector cell engagement and efficient B-cell depletion. Preclinical data demonstrates that compared to the other anti-CD20s approved or used to treat MS, BRIUMVI has the highest binding affinity to CD20. The target for these types of drugs found on B-cells, and through its glycoengineering has the ability to induce the highest level of antibody-dependent cellular cytotoxicity regardless of patient-specific polymorphisms. Whether or not these biological attributes of BRIUMVI have clinical relevance in patients with MS has not yet been determined, as no head-to-head trials have been conducted for BRIUMVI versus the other anti-CD20s.

需要提醒的是，BRIUMVI 的設計與眾不同，經過糖基工程改造，可增強免疫效應細胞的參與並有效消除 B 細胞。臨床前數據表明，與其他已批准或用於治療 MS 的抗 CD20 藥物相比，BRIUMVI 對 CD20 具有最高的結合親和力。在 B 細胞上發現的此類藥物的靶標，透過其糖工程，能夠誘導最高水平的抗體依賴性細胞毒性，無論患者特異性多態性如何。BRIUMVI 的這些生物學特性對於 MS 患者是否具有臨床意義尚未確定，因為尚未對 BRIUMVI 與其他抗 CD20 進行頭對頭試驗。

However, what has been well-established is that BRIUMVI is the only anti-CD20 monoclonal antibody to achieve an annualized relapse rate of less than 0.1 in Phase 3 trials. Also, in clinical trials, BRIUMVI rapidly depleted B-cells with a median of 96% reduction within 24 hours and 95% on-time infusion completion rate, which we believe speaks to the tolerability profile of BRIUMVI.

然而，已經確定的是，BRIUMVI 是唯一一種在 3 期試驗中年復發率低於 0.1 的抗 CD20 單株抗體。此外，在臨床試驗中，BRIUMVI 迅速耗盡 B 細胞，24 小時內平均減少 96%，按時輸注完成率為 95%，我們相信這說明了 BRIUMVI 的耐受性。

As we move forward, we are eager to explore to what degree the design attributes of BRIUMVI may be contributing to the robust activity scene. We plan to do more work to evaluate some of these unique attributes and to understand whether the molecular and non-clinical differentiation translates into clinical differences. And we look forward to sharing more on that when available.

隨著我們的前進，我們渴望探索 BRIUMVI 的設計屬性在多大程度上對強大的活動場景做出了貢獻。我們計劃做更多的工作來評估其中一些獨特的屬性，並了解分子和非臨床差異是否會轉化為臨床差異。我們期待在可用時分享更多相關內容。

I also wanted to highlight another recent exciting development. We were pleased to share yesterday that in addition to our current BRIUMVI patent and US Biologics exclusivity, the US Patent and Trademark Office recently issued three additional patents for BRIUMVI, including a composition of matter, patent related to the glycoengineered attributes of BRIUMVI. With these additional patents, our patent protection now extends through 2042, providing us a nice long runway to continue to explore the full potential of BRIUMVI, including expanding the potential reach of BRIUMVI in MS, as well as into other autoimmune diseases, which is a good segue to discuss what is next for BRIUMVI and TG.

我還想強調最近另一個令人興奮的發展。昨天我們很高興地與大家分享，除了我們目前的BRIUMVI 專利和美國生物製品獨家專利之外，美國專利商標局最近還為BRIUMVI 頒發了三項額外專利，其中包括與BRIUMVI 糖工程屬性相關的物質組合物專利。有了這些額外的專利，我們的專利保護現在可以延長到2042 年，為我們提供了一條良好的長跑道，繼續探索BRIUMVI 的全部潛力，包括擴大BRIUMVI 在MS 以及其他自體免疫疾病中的潛在影響範圍，這是一種很好地繼續討論 BRIUMVI 和 TG 的下一步。

First, let me say that the US BRIUMVI launch and commercialization is and will remain our highest priority. That said, our drug development team is poised and ready to potentially drive additional value through BRIUMVI lifecycle management activities, as well as new drug development. More specifically, we are focused in four key areas.

首先，我要說的是，美國 BRIUMVI 的啟動和商業化現在是、將來仍然是我們的首要任務。也就是說，我們的藥物開發團隊已做好準備，透過 BRIUMVI 生命週期管理活動以及新藥開發潛在地推動附加價值。更具體地說，我們專注於四個關鍵領域。

First, in making IV BRIUMVI even more convenient. Last year, we presented the first data from the enhanced Phase 3b trial, of which the goal is to evaluate the safety and efficacy of eliminating the four-hour BRIUMVI 150-milligram starting dose for patients who are switching from a prior CD20 and have a pre-specified low level of B-cells. Early safety data from this study is encouraging, and we look forward to presenting additional safety and efficacy data this year, including at the ECTRIMS Conference, which is happening later this week.

首先，讓 IV BRIUMVI 更方便。去年，我們提供了增強型 3b 期試驗的第一個數據，該試驗的目標是評估對於從先前的 CD20 轉換為現有 CD20 的患者取消 4 小時 BRIUMVI 150 毫克起始劑量的安全性和有效性。預先指定的低水平B 細胞。這項研究的早期安全性數據令人鼓舞，我們期待今年提供更多的安全性和有效性數據，包括在本週稍後舉行的 ECTRIMS 會議上。

A second key area for us is developing subcu BRIUMVI. We have completed our preliminary subcu formulation and are preparing to enter human bioequivalent studies this year. We believe this subcu market could represent a significant new market opportunity for us, as the IV and subcu CD20 markets within RMS are rather distinct. Given the known profile of the currently available subcu and the profile of the other one under development, we believe there is plenty of room to strive to develop a potentially best-in-class subcu CD20 product.

我們的第二個關鍵領域是開發 subcu BRIUMVI。我們已經完成了初步的 subcu 配方，並準備今年進入人體生物等效性研究。我們相信這個 subcu 市場對我們來說可能代表著一個重要的新市場機會，因為 RMS 內的 IV 和 subcu CD20 市場相當不同。鑑於目前可用的 subcu 的已知概況以及正在開發的另一種 subcu 的概況，我們相信有足夠的空間來努力開發潛在的同類最佳 subcu CD20 產品。

Third, we are looking forward to expanding BRIUMVI beyond MS. There are multiple other disease indications where CD20s have proven to have utility. We look forward to launching our first autoimmune trial outside of MS this year.

第三，我們期待將 BRIUMVI 擴展到 MS 之外。CD20 已被證明在多種其他疾病適應症中具有實用性。我們期待今年在多發性硬化症之外啟動第一個自體免疫試驗。

And fourth and finally, we are focused on new drug development and are extremely excited by our recent portfolio expansion. Last month, we entered into a partnership with Precision BioSciences to acquire a worldwide license to Precisions azer-cel, allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications.

第四，也是最後一點，我們專注於新藥開發，並對我們最近的產品組合擴張感到非常興奮。上個月，我們與Precision BioSciences 建立了合作夥伴關係，獲得了Precisions azer-cel 的全球許可，這是一種用於自體免疫疾病和所有其他非腫瘤適應症的同種異體CD19 CAR T 細胞治療專案.

We believe azer-cel has the potential to be a first-in-class, best-in-class treatment for certain autoimmune diseases. As an allogeneic off-the-shelf product, we think azer-cel may offer benefits over autologous CAR T treatments. Overall, we believe azer-cel is a great fit for us and an important addition to our current pipeline. Azer-cel has been used to treat over 80 cancer patients and we look forward to hopefully treating the first autoimmune patients with azer-cel as soon as possible with an IND filing targeted for mid-year.

我們相信 azer-cel 有潛力成為治療某些自體免疫疾病的一流、最佳療法。作為一種同種異體現成產品，我們認為 azer-cel 可能比自體 CAR T 治療更有優勢。總的來說，我們相信 azer-cel 非常適合我們，也是我們目前產品線的重要補充。Azer-cel 已被用於治療 80 多名癌症患者，我們期待盡快用 azer-cel 治療第一批自體免疫患者，並在年中提交 IND 申請。

As you can see, we have put together a thoughtful and exciting development plan for 2024 and beyond that we believe can add significant value to our shareholders. We have been and will continue to be measured in our approach to R&D from a capital allocation perspective, included in our approximately $250 million and projected 2024 operating budget of the dollars required to expand our BRIUMVI field teams, increase our marketing spend, as well as moving forward, all of the current development plans we've just discussed.

正如您所看到的，我們為 2024 年及以後製定了深思熟慮且令人興奮的發展計劃，我們相信該計劃可以為我們的股東增加巨大的價值。我們已經並將繼續從資本分配的角度衡量我們的研發方法，包括在我們約 2.5 億美元和預計 2024 年營運預算中，擴大我們的 BRIUMVI 現場團隊、增加我們的行銷支出以及展望未來，我們剛才討論的所有當前發展計劃。

With that, as I bring my prepared remarks to a close, I'd like to say how incredibly proud I am of the team and the progress we've made in 2023. We built a top-notch MS-focused commercial team that enabled us to rapidly integrate TG and BRIUMVI into the MS ecosystem. We will continue to build upon this foundation with TG as a trusted partner to the MS community as we strive to serve the patients we treat to the best of our ability.

至此，在我準備好的發言結束時，我想說我對我們的團隊以及我們在 2023 年的進步感到無比自豪。我們建立了一支以 MS 為中心的一流商業團隊，使我們能夠將 TG 和 BRIUMVI 快速整合到 MS 生態系統中。我們將繼續在此基礎上與 TG 作為多發性硬化症社區值得信賴的合作夥伴，努力盡最大努力為我們治療的患者提供服務。

Finally, I also want to congratulate our ex-US partner Neuraxpharm on the official launch of BRIUMVI in Europe, which took place this week in Germany. We look forward to hearing more about their progress as they endeavor to commercialize BRIUMVI in Europe and the rest of the world.

最後，我還要祝賀我們的前美國合作夥伴 Neuraxpharm 本週在德國正式在歐洲推出 BRIUMVI。我們期待更多地了解他們在歐洲和世界其他地區努力將 BRIUMVI 商業化的進展。

With that, let me hand the call over to Adam Waldman, our Chief Commercialization Officer, to provide a detailed update of the BRIUMVI US commercial launch. Adam?

接下來，讓我將電話轉交給我們的首席商業化官 Adam Waldman，以提供 BRIUMVI 美國商業發布的詳細更新資訊。亞當？

Thank you, Mike, and good morning, everyone. I'm pleased to share with you the results from the fourth quarter and cover the highlights from our BRIUMVI commercial launch performance in 2023.

謝謝你，麥克，大家早安。我很高興與您分享第四季度的業績，並介紹我們 2023 年 BRIUMVI 商業發布業績的亮點。

Launching BRIUMVI last year was a transformational event for our company. We've built a strong commercial infrastructure that delivered exceptional results, exceeded expectations on the launch, and now provides a solid platform for which to build potential blockbuster products in MS and capitalize on other autoimmune disease opportunities going forward. And more importantly, we made a positive difference in the lives of thousands of people living with MS.

去年推出 BRIUMVI 對我們公司來說是個轉型事件。我們已經建立了強大的商業基礎設施，取得了卓越的成果，超越了發佈時的預期，現在提供了一個堅實的平台，可以在多發性硬化症領域構建潛在的重磅產品，並利用未來其他自身免疫性疾病的機會。更重要的是，我們為成千上萬多發性硬化症患者的生活帶來了積極的改變。

As reported at the JP Morgan Conference last month, fourth quarter net sales for BRIUMVI were $39.9 million, representing 60% growth quarter-over-quarter and bringing our full year 2023 revenues in at $89 million. The fourth quarter number exceeded our guidance and reflects the growing demand we are seeing for BRIUMVI. We saw an increasing number of repeat prescribers and incremental gains in new prescribers and new centers adopting BRIUMVI.

根據上個月摩根大通會議報道，BRIUMVI 第四季淨銷售額為 3,990 萬美元，季增 60%，使我們 2023 年全年營收達到 8,900 萬美元。第四季度的數字超出了我們的指導，反映出我們對 ​​BRIUMVI 的需求不斷增長。我們看到重複處方者的數量不斷增加，並且採用 BRIUMVI 的新處方者和新中心的數量不斷增加。

We also started seeing increasing prescribing from major academic centers in the fourth quarter as the logistical barriers at these centers continue to decrease. In fact, the fourth quarter was the first time we saw more scripts from academic centers than in a private practice setting, which we view as positive progress given that 60% to 65% of patients are being seen by MS specialists in the academic setting, and this has been a focus for our team as we headed into the end of the year.

隨著主要學術中心的後勤障礙不斷減少，我們在第四季也開始看到這些中心的處方量增加。事實上，第四季度是我們第一次看到來自學術中心的腳本比私人診所的腳本多，我們認為這是積極的進展，因為60% 至65% 的患者正在學術環境中接受多發性硬化症專家的診治，當我們進入年底時，這一直是我們團隊的焦點。

Overall, in 2023 we saw approximately 3,200 new patient prescriptions come through our hub, which we believe translates into about 3,500 total new patient scripts as not all new prescriptions will come into our hub. We're also pleased to see a wide distribution of use with new prescriptions coming from over 400 centers and 640 unique prescribers.

總體而言，2023 年，我們看到大約 3,200 個新患者處方通過我們的中心，我們相信這意味著總共大約 3,500 個新患者處方，因為並非所有新處方都會進入我們的中心。我們也很高興看到來自 400 多個中心和 640 名獨特處方者的新處方被廣泛使用。

Encouragingly, we also saw a diverse mix of patient types, including those that were naive to all treatments and those that were previously treated and switched from both non-CD20 and CD20 agents. This mix of patient types remained fairly consistent throughout the year, with the largest group consisting of patients that were previously treated, but naive to anti-CD20 therapy. We were also highly encouraged by the persistence of returning patients, which so far appears to be consistent with our assumptions, which was based on what had been seen with the other IV anti-CD20 on the market.

令人鼓舞的是，我們也看到了各種各樣的患者類型，包括那些從未接受過所有治療的患者以及之前接受過非 CD20 和 CD20 藥物治療並轉用的患者。這種患者類型的組合在全年中保持相當一致，其中最大的組別由先前接受過治療但未接受過抗 CD20 治療的患者組成。我們也對返回患者的持續存在感到非常鼓舞，到目前為止，這似乎與我們的假設一致，我們的假設是基於市場上其他 IV 抗 CD20 的觀察結果。

From an execution perspective, our teams did an exceptional job delivering on our launch plan in 2023. We had a well-designed and targeted launch strategy, efficiently focusing our resources on driving adoption at high-volume, targeted accounts where we saw the vast majority of our business.

從執行角度來看，我們的團隊出色地完成了 2023 年的發布計畫。我們制定了精心設計且有針對性的啟動策略，有效地將我們的資源集中在推動大批量、目標客戶的採用上，而我們的絕大多數業務都在這些客戶中。

At this point, approximately 90% of the top 100 centers in the US have utilized BRIUMVI. And with the lowest price of any branded medicine for MS, we prioritized gaining early access and coverage, and were able to achieve coverage for 95% of commercial and Medicare lives within the first nine months of launch.

目前，美國排名前 100 的中心中約有 90% 都使用了 BRIUMVI。憑藉所有 MS 品牌藥物中價格最低的優勢，我們優先考慮獲得早期使用和覆蓋，並能夠在推出的前 9 個月內實現 95% 的商業和醫療保險覆蓋。

We built a best-in-class patient support team, and our highly experienced and well-networked field teams have done an incredible job establishing TG as a respected partner in the MS community. We are very proud of our teams and believe their outstanding efforts are contributing to the positive experience with BRIUMVI and continue to build confidence in our organization.

我們建立了一支一流的患者支援團隊，我們經驗豐富、網路良好的現場團隊做了令人難以置信的工作，使 TG 成為 MS 社群中受人尊敬的合作夥伴。我們為我們的團隊感到非常自豪，並相信他們的傑出努力正在為 BRIUMVI 帶來積極的體驗，並繼續建立對我們組織的信心。

The cumulative effects of what we've accomplished certainly helped to drive momentum that we saw in 2023, and we expect to see that momentum carry forward this year. Looking forward, we see the CD20 market continuing to grow. This class of drugs has transformed the way that MS is treated over the last five years, with the CD20 share continuing to grow and now capturing approximately 50% to 55% share of new patients every year. And we would expect that that will expand even further going forward.

我們所取得的成就的累積效應無疑有助於推動我們在 2023 年看到的勢頭，我們預計今年將看到這種勢頭繼續下去。展望未來，我們看到 CD20 市場持續成長。在過去五年中，此類藥物改變了多發性硬化症的治療方式，CD20 的份額持續成長，目前每年約佔新患者的 50% 至 55%。我們預計這種情況將進一步擴大。

We believe this is a continued tailwind for our business. We also expect that most patients and centers will continue to prefer an every-six-month IV dosing schedule, where patients don't have to think about their disease every day or every month, and providers have the confidence that their patients are being compliant receiving their medication.

我們相信這對我們的業務來說是持續的推動力。我們也預期大多數患者和中心將繼續更喜歡每六個月一次的靜脈注射給藥方案，這樣患者不必每天或每月考慮自己的疾病，並且提供者有信心他們的患者會遵守規定接受他們的藥物。

We estimate there are approximately 40,000 patients going on a CD20 therapy each year, or about 10,000 patients per quarter. And in the fourth quarter of 2023, we had approximately 1,000 prescriptions come into the TG Hub, which would reflect approximately a 10% market share if all these patients were infused.

我們估計每年約有 40,000 名患者接受 CD20 治療，或每季約有 10,000 名患者。2023 年第四季度，我們有大約 1,000 個處方進入 TG Hub，如果所有這些患者都接受輸液，這將反映約 10% 的市場份額。

Since not all these patients prescribed BRIUMVI will actually be infused, these prescriptions through the Hub will not translate precisely into market share. But nevertheless, we do believe this is an indicator of strong early demand for BRIUMVI, especially in our first year of launch.

由於並非所有開出 BRIUMVI 的患者都會真正接受輸注，因此透過中心開出的這些處方不會準確地轉化為市場份額。但儘管如此，我們確實相信這是對 BRIUMVI 早期需求強勁的一個指標，尤其是在我們推出的第一年。

We also believe we have significant room to grow in what is a large and growing and expanding market. Based on our market research and extensive interaction with neurologists, we continue to believe BRIUMVI's profile remains very compelling and will eventually be the IV therapy of choice in the relapsing MS market. This will of course take us time to achieve, but that's very much what we're focused on doing.

我們也相信，在這個龐大且不斷成長和擴大的市場中，我們有巨大的成長空間。根據我們的市場研究以及與神經科醫生的廣泛互動，我們仍然相信 BRIUMVI 的形象仍然非常引人注目，並且最終將成為復發性多發性硬化症市場的首選靜脈注射療法。當然，這需要我們花一些時間才能實現，但這正是我們重點要做的事情。

In 2024 we'll expand our targets and continue to work on educating our customers on the BRIUMVI difference. We'll also continue to ramp up our efforts to increase patient awareness, which we believe can be an important driver in this market. So far, this year is off to a really strong start, where we have seen record enrollments into our Hub in January. And we believe we are tracking towards the upper end of our first quarter guidance range of $41 million to $46 million, and potentially higher if demand trends persist over the next month.

2024 年，我們將擴大我們的目標，並繼續努力讓我們的客戶了解 BRIUMVI 的差異。我們也將持續加強提高患者意識，我們相信這將成為該市場的重要驅動力。到目前為止，今年已經有了一個非常強勁的開局，我們在一月份的中心註冊人數創下了紀錄。我們相信，我們正在朝著第一季指導範圍 4,100 萬美元至 4,600 萬美元的上限邁進，如果下個月需求趨勢持續下去，可能會更高。

We also feel very good about our full year guidance of $220 million to $260 million, which we provided at JP Morgan. We certainly have work to do, but we are focused and extremely motivated to continue to work every day to bring BRIUMVI to those people living with MS and their families.

我們也對摩根大通提供的 2.2 億至 2.6 億美元的全年指引感到非常滿意。我們當然還有工作要做，但我們專注並非常積極地繼續每天工作，將 BRIUMVI 帶給那些多發性硬化症患者及其家人。

With that, I'll turn the call over to Sean Power, our CFO.

接下來，我會將電話轉給我們的財務長 Sean Power。

Thank you, Adam, and thanks again to everyone for joining us. Earlier this morning we reported our detailed fourth quarter and full year 2023 financial results, which can be viewed on the investors and media section of our website.

謝謝你，亞當，再次感謝大家加入我們。今天早些時候，我們報告了詳細的第四季度和 2023 年全年財務業績，您可以在我們網站的投資者和媒體部分查看該業績。

This morning, I'll start with a discussion of our revenue for the fourth quarter and full year of 2023. As previously mentioned, we are pleased to report US BRIUMVI net product revenue of $39.9 million during the fourth quarter.

今天早上，我將首先討論我們 2023 年第四季和全年的收入。如前所述，我們很高興地報告第四季度美國 BRIUMVI 產品淨收入為 3,990 萬美元。

Also included in our total net product revenue for the fourth quarter is approximately $3.2 million of revenue for products sold to Neuraxpharm in support of the ex-US commercial launch, and $800,000 of other revenue, taking total revenue for the fourth quarter to approximately $44 million as reported.

我們第四季的總淨產品收入還包括出售給 Neuraxpharm 以支持在美國以外商業上市的產品的約 320 萬美元收入，以及 80 萬美元的其他收入，使第四季度的總收入達到約 4,400 萬美元據報道。

For the full year, we reported total revenue of approximately $234 million, which is predominantly comprised of $88.8 million in US BRIUMVI net product sales, $140 million in license revenue stemming from the upfront payment for our ex-US commercialization agreement with Neuraxpharm, and $3.2 million in product revenue for products sold to Neuraxpharm, as previously mentioned.

我們報告的全年總收入約為2.34 億美元，其中主要包括8,880 萬美元的美國BRIUMVI 產品淨銷售額、1.4 億美元的授權收入（來自我們與Neuraxpharm 的美國前商業化協議的預付款）以及3.2美元。如前所述，出售給 Neuraxpharm 的產品帶來了 100 萬美元的產品收入。

Our OpEx during the fourth quarter and full year has remained well controlled and in line with previously discussed ranges. For the fourth quarter and full year 2023, our operating expenses were $56 million and $213 million respectively, which includes COGS of $7.8 million and $14.1 million in the respective periods. When excluding on cash compensation, our cash operating expenditures during the fourth quarter and full year 2023 were approximately $47 million and $175 million respectively.

我們第四季和全年的營運支出保持良好控制並符合先前討論的範圍。2023 年第四季和全年，我們的營運費用分別為 5,600 萬美元和 2.13 億美元，其中包括相應期間的銷貨成本 (COGS) 780 萬美元和 1,410 萬美元。在排除現金補償後，我們在 2023 年第四季和全年的現金營運支出分別約為 4,700 萬美元和 1.75 億美元。

On the back of the reported revenues and well-controlled OpEx, we were able to report net income of $12.7 million or $0.09 per diluted share during the full year of 2023. For the fourth quarter of 2023, we reported a net loss of $14.4 million or $0.09 per diluted share.

在報告的收入和良好控制的營運支出的支持下，我們在 2023 年全年報告淨利潤為 1,270 萬美元，即稀釋後每股收益 0.09 美元。2023 年第四季度，我們報告淨虧損 1,440 萬美元，即稀釋後每股虧損 0.09 美元。

And finally, from a cash standpoint, we ended the year with approximately $217.5 million in cash, cash equivalents and investment security. And we believe our current cash position, coupled with our previously guided revenue and expense guidance, provides us with sufficient capital to fund our operations to cash flow positivity.

最後，從現金的角度來看，我們在年底擁有約 2.175 億美元的現金、現金等價物和投資擔保。我們相信，我們目前的現金狀況，加上我們先前指導的收入和支出指導，為我們提供了足夠的資本來為我們的營運提供現金流積極性。

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

現在，我將把電話轉給會議接線員以開始問答。

Thank you. The floor is now open for questions. (Operator Instructions). Michael DiFiore, Evercore.

謝謝。現在可以提問。（操作員說明）。邁克爾·迪菲奧裡，Evercore。

Hi. This is Jessica, on for Mike. My first question is, in the past you guys have said that you've heard anecdotal reports of patients not petering out in the days and weeks leading up to their subsequent BRIUMVI dose, which is not always the case with competitor anti-CD20s. So what's been the feedback on this front, and how much do you see BRIUMVI's consistent treatment duration as a key differentiating factor?

你好。我是傑西卡，替麥克發言。我的第一個問題是，你們過去曾說過，你們聽說過一些軼事報道稱，患者在接受後續BRIUMVI 劑量之前的幾天或幾週內病情並未逐漸消失，而競爭對手的抗CD20藥物的情況並非總是如此。那麼這方面的回饋是什麼？您認為 BRIUMVI 的持續治療持續時間在多大程度上是關鍵的差異化因素？

And then also, if I can sneak in another question, what can we expect on growth-to-net cadence for the balance of the year? Thank you.

另外，如果我可以偷偷提出另一個問題，我們對今年剩餘時間的淨成長節奏有何期望？謝謝。

Got it. Thanks for the question. Adam, you want to field the first one, and then I'll have Sean take the second.

知道了。謝謝你的提問。亞當，你想派第一個，然後我請肖恩派第二個。

Persistence, I assume you mean the discontinuation rate for patients going from first or second infusion to third infusion. As you know, it's still early, but what I said in my remarks is true so far that the trends seem positive and around what we expected based on what we saw with the other IV CD20. So it's right in that range.

持久性，我認為您指的是患者從第一次或第二次輸注到第三次輸注的停藥率。如您所知，現在還為時過早，但到目前為止，我在發言中所說的都是正確的，趨勢似乎是積極的，並且與我們根據我們在其他IV CD20 上看到的情況所預期的一致。所以它就在這個範圍內。

I don't have any information right now to say that it's better. I certainly don't have any information to say that it's worse, but its right where we expected, and we'll continue to look at it. Certainly, if it's more positive than we think, certainly that will be an accelerator going forward.

我現在沒有任何資訊可以說它更好。我當然沒有任何資訊表明情況更糟，但它正是我們所期望的，我們將繼續關注它。當然，如果它比我們想像的更積極，那肯定會成為未來的加速器。

Hi. And on the growth-to-net front, we have not provided going forward guidance on what to expect. There will be some variability quarter-to-quarter, but again, we haven't provided precise guidance on what 2024 will look like.

你好。在淨成長方面，我們尚未提供有關預期的未來指導。每個季度都會有一些變化，但同樣，我們還沒有就 2024 年的情況提供準確的指導。

Great. Thank you.

偉大的。謝謝。

Thank you.

謝謝。

Ed White, H.C. Wainwright.

懷特，H.C.溫賴特。

So just wondering if you have any numbers on the switches from prior therapies and how that's impacting your sales growth.

因此，我想知道您是否有關於先前療法的轉變的任何數據，以及這對您的銷售成長有何影響。

Yeah. So I'll start there, and Adam can jump in. We haven't provided anything new. I mean, what we've said previously, and it still holds true, is that in terms of distribution of patients, we have three buckets. Just to be clear, there's patients that are naive to all treatment. There's patients that switch from non-CD20 products to CD20, so there's the non-CD20 and there's the CD20 switches.

是的。所以我將從這裡開始，亞當可以介入。我們沒有提供任何新內容。我的意思是，我們之前說過，現在仍然有效，那就是，就患者的分佈而言，我們有三個桶子。需要明確的是，有些患者對所有治療都很幼稚。有些患者從非 CD20 產品轉向 CD20，因此有非 CD20 和 CD20 轉換。

What we've said is that the largest group coming on to BRIUMVI are those that were naive to CD20 but were pretreated with something else. And then the other two buckets, while they are not equal to each other, are relatively similar and they are reasonably close to the first bucket. So there's usually -- there's a nice distribution across all the buckets.

我們所說的是，進入 BRIUMVI 的最大群體是那些對 CD20 沒有了解但接受過其他治療的人。然後，其他兩個桶子雖然彼此不相等，但相對相似，並且相當接近第一個桶。所以通常所有的桶子都有一個很好的分佈。

Okay. Thanks Mike. And on Europe, congratulations on getting the launch in Germany. Can you give us your thoughts on the launch in Germany and in other countries and perhaps the cadence of future milestone payments?

好的。謝謝邁克。至於歐洲，恭喜您在德國推出。您能否告訴我們您對在德國和其他國家推出該產品以及未來里程碑付款節奏的想法？

Yeah. Adam, you've been a lot closer. You want to take a crack?

是的。亞當，你離我們更近了。你想嘗試嗎？

Sure. Hi Ed. So yeah, as you know and as we've spoken about before, getting BRIUMVI launched in Germany was really important. It's the biggest market by far in Europe. So getting that going out of the start was important and we are right on track with that, which is great.

當然。嗨艾德。所以，是的，正如您所知，正如我們之前談到的，在德國推出 BRIUMVI 非常重要。這是迄今為止歐洲最大的市場。因此，從一開始就做到這一點很重要，我們正在朝著這個方向前進，這很棒。

The other countries will start to come in the later part of this year into next year, including the UK, France, Spain, Italy, and they are continuing to work with the reimbursement authorities and getting through the process they need to in making sure the drug can be accessed.

其他國家將於今年下半年到明年開始實施，包括英國、法國、西班牙、義大利，他們正在繼續與報銷機構合作，並完成所需的流程，以確保可以獲得藥物。

They are working diligently on that. They have a lot of experience doing it and will continue to work through the process. But Germany is by far the largest opportunity and the one that we prioritized first.

他們正在為此努力。他們在這方面擁有豐富的經驗，並將繼續完成整個過程。但德國是迄今為止最大的機會，也是我們首先優先考慮的機會。

Yeah. And then just on the cadence of future milestones, we are not expecting any additional milestones this year. There's a chance we would see a milestone toward the end of next year, an additional milestone, but we'll get more on that later. But I wouldn't expect any additional milestones this year. As we reported to Morgan, obviously it's a launch year for these folks and we're not expecting a whole lot in royalty revenues as well.

是的。然後就未來里程碑的節奏而言，我們預計今年不會有任何額外的里程碑。我們有可能在明年年底看到一個里程碑，一個額外的里程碑，但我們稍後會得到更多資訊。但我預計今年不會有任何額外的里程碑。正如我們向摩根報告的那樣，顯然今年對這些人來說是一個啟動年，我們預計特許權使用費收入不會很高。

Okay. Thanks Mike. And just lastly, Adam had mentioned adding to the sales force and expanding your reach. How should we be thinking about that as far as the growth or the ramp of SG&A expenses? Are you currently adding? Is this something that we should see in the second half of the year or just any guidance that you can give us on how you are expanding your sales force?

好的。謝謝邁克。最後，亞當提到增加銷售團隊並擴大影響力。就銷售、管理及行政費用的成長或增加而言，我們應該如何考慮這一點？您目前正在新增嗎？這是我們應該在下半年看到的事情，還是您可以向我們提供有關如何擴大銷售團隊的任何指導？

Yeah. So I'll chime in, and Adam and Sean could jump in afterwards. Yeah, so as it stands today, even in the fourth quarter, some of that expansion -- actually, most of that expansion is already included of the current expansion process. So it's already probably built in most of it into the fourth quarter and there'll probably be a little bit more that trickles into the first quarter.

是的。所以我會插話，然後 Adam 和 Sean 也可以插話。是的，就目前情況而言，即使在第四季度，部分擴張 - 實際上，大部分擴張已經包含在當前的擴張過程中。因此，大部分內容可能已經在第四季度完成，並且可能會有更多內容進入第一季。

And then it's possible over the course of the year, there'll be a slow additional build. But most of its already incorporated and for sure it's incorporated in our OpEx estimate of approximately $250 million for the year. So that's all built into what we are guiding already.

然後，在這一年中，可能會出現緩慢的額外建設。但其中大部分已經納入其中，並且肯定已納入我們預計的今年約 2.5 億美元的營運支出中。因此，這一切都已納入我們已經指導的內容中。

Okay. Thanks Mike.

好的。謝謝邁克。

You got it, Ed. Thanks.

你明白了，艾德。謝謝。

Roger Song, Jefferies.

羅傑·宋，杰弗里斯。

Hi. This is Kambiz, on for Roger. Hi, Mike and team. Good morning. What timeframe do you think it's possible to achieve the number one prescribed IV CD20 for BRIUMVI by dynamic share? And as a second question, are there any remaining gating factors for you to enter the human bioequivalence studies for subcu formulations of BRIUMVI there?

你好。這是卡姆比茲，代表羅傑發言。嗨，麥克和團隊。早安.您認為在什麼時間範圍內可以透過動態共享實現 BRIUMVI 的第一規定 IV CD20？第二個問題，是否還有任何剩餘的限制因素可以讓您進入 BRIUMVI subcu 製劑的人體生物等效性研究？

Yeah, you broke up a little bit at the end there, but I think I got it. In terms of timeframe to be number one, we haven't set a timeframe yet, so I can't share one. It's a goal that we have and we're going to keep working toward it. But certainly, as we get further along, I mean, I don't anticipate ‘24 will be the year that we do that. So I think that's pretty sure about that, but we are working toward that, and we'll keep you posted.

是的，你們最後分手了一點，但我想我明白了。就成為第一的時間表而言，我們還沒有設定時間表，所以我無法分享。這是我們的目標，我們將繼續努力實現這一目標。但當然，隨著我們的進一步進展，我的意思是，我預計 24 年不會是我們這樣做的一年。所以我認為這是非常確定的，但我們正在努力實現這一目標，我們會隨時向您通報最新情況。

In terms of the subcu development, we do have our preliminary subcu formulation that we want to take into the clinic. We don't think that there's anything in our way to do that. We've got some filings to do, but it should be pretty straightforward, and we're hoping to have patients on, hopefully by mid-year.

在 subcu 開發方面，我們確實有初步的 subcu 配方，我們希望將其應用於臨床。我們認為沒有什麼可以阻止我們做到這一點。我們需要提交一些文件，但應該非常簡單，我們希望能夠在年中之前讓患者接受治療。

Excellent. And then maybe as a couple of follow-up questions, is there any preparatory work required to enter BRIUMVI into studies outside of MS? And as a last question, we've noticed there's still a small number of scripts in third-party trackers. Some investors are still curious about the trends. Maybe we could put this topic to bed for once and all. Do you see any value at all in a third-party script tracker going to data?

出色的。然後也許作為幾個後續問題，將 BRIUMVI 納入 MS 之外的研究是否需要任何準備？作為最後一個問題，我們注意到第三方追蹤器中仍然存在少量腳本。一些投資者仍然對趨勢感到好奇。也許我們可以暫時擱置這個話題。您認為第三方腳本追蹤器取得資料有任何價值嗎？

Yeah, I would certainly love that. Adam, you want to hit that one on the third party?

是的，我當然會喜歡這樣。亞當，你想向第三方發動攻擊嗎？

Yeah sure. From what I understand, Roger -- or it wasn't Roger, but -- sorry, so what I understand is, the data you are seeing is SP data, which is a very small portion of our business, less than 10%. So yes, to put it to bed, I would say it is absolutely not something I would look at.

好，當然。據我了解，羅傑——或者不是羅傑，但是——抱歉，所以我的理解是，你看到的數據是SP數據，它只占我們業務的一小一部分，不到10%。所以，是的，為了把它放在床上，我想說這絕對不是我會看的東西。

Great. Thank you.

偉大的。謝謝。

And then your last question about moving outside of MS. I don't think there's any pre-work that we need to do. I think it's just logistics of getting it done within the context of all the other things that we have on our plate for this year.

然後是關於離開 MS 的最後一個問題。我認為我們不需要做任何前期工作。我認為這只是在我們今年要做的所有其他事情的背景下完成它的後勤工作。

So that's probably a later-in-the-year event than an earlier year. I think we've got -- the higher priority projects will be the stuff I talked about where we are trying to make IV BRIUMVI even more convenient. The subcu and the azer-cel stuff is probably on a higher priority setting for the earlier part of the year. But yeah, I don't see any barriers to going outside of MS.

因此，這可能是今年稍後的事件，而不是早年的事件。我認為我們已經--更高優先事項的項目將是我談到的我們正在努力使 IV BRIUMVI 更加方便的項目。subcu 和 azer-cel 的東西可能在今年早些時候處於更高的優先級設定。但是，是的，我認為走出 MS 沒有任何障礙。

Thanks Mike. I appreciate it.

謝謝邁克。我很感激。

You got it. Thank you.

你說對了。謝謝。

Matt Kaplan, Ladenburg Thalmann.

馬特卡普蘭，拉登堡塔爾曼。

Hey, good morning, guys, and congrats on the progress. Just to stay on the enhanced -- yeah, good morning. Just to stay on the enhanced Phase 3b switching trial, can you provide a little bit more information in terms of what we should be looking for from that data as it's released at, I guess, ACTRIMS and at later conferences this year?

嘿，早安，夥計們，祝賀你們取得的進展。只是為了繼續增強——是的，早安。為了繼續進行增強型 3b 期轉換試驗，您能否提供更多信息，說明我們應該從 ACTRIMS 以及今年晚些時候的會議上發布的數據中尋找什麼內容？

Matt, it's like a day or two away, really? (laughter) You want me to give it all away? Yeah, I mean, look, so what are we trying to accomplish? I think it's a fair question. So we want to make it as easy as possible for folks to be able to switch seamlessly from another CD20 on to BRIUMVI.

馬特，大約有一兩天的時間，真的嗎？（笑聲）你想讓我把一切都放棄嗎？是的，我的意思是，看，我們要達成什麼目標？我認為這是一個公平的問題。因此，我們希望讓人們盡可能輕鬆地從另一個 CD20 無縫切換到 BRIUMVI。

It's no secrets. Doing an extra four-hour infusion is not the ideal situation for that patient population who already are B-cell depleted. So the goal is -- step one is, can you safely take a patient who's on another drug, they are B-cell depleted, and put them on another CD20 without this initial conditioning with a regimen that we have for the starting dose? So that's step one. So safety is the utmost importance, and that's what we wanted to do.

這不是什麼秘密。對於 B 細胞已經耗盡的患者群體來說，額外進行四小時的輸注並不是理想的情況。所以我們的目標是——第一步是，你能否安全地讓正在服用另一種藥物的患者（他們的B 細胞已耗盡），並讓他們接受另一種CD20 治療，而無需使用我們的起始劑量方案進行初步調節？這是第一步。因此，安全是最重要的，這就是我們想要做的。

Partly we wanted to get that done too, because we had heard in the field that people were just switching people straight through to one-hour BRIUMVI. So we wanted to make sure we have safety.

部分原因是我們也想做到這一點，因為我們在現場聽到人們只是直接將人員切換到一小時的 BRIUMVI。所以我們想確保我們的安全。

The next part is, look, I think we would love to get it into the label. We are eliminating 150 milligrams of drug, so there will be an efficacy question. I don't think it's a material efficacy question, but it has to be answered. So I think as we move forward, one, what are we looking for? Make sure it's safe and well-tolerated to switch people directly to a one-hour BRIUMVI from another CD20. And if there's any signal that we'd somehow be losing some activity by eliminating the 150 milligrams.

下一部分是，看，我想我們很樂意將其納入標籤中。我們正在消除 150 毫克藥物，因此會有療效問題。我不認為這是一個物質功效問題，但它必須得到答案。所以我認為，隨著我們前進，第一，我們在尋找什麼？確保將人們從另一台 CD20 直接切換到一小時 BRIUMVI 是安全且耐受性良好的。如果有任何訊號表明我們會因減少 150 毫克而失去一些活性。

So I think we're still probably in the safety phase of this trial. So I think in ACTRIMS we'll be looking for more safety information. Probably by the time we get to ECTRIMS, we should be able to have some additional efficacy. Again, its single-arm, so the efficacy information will be, pretty straightforward, looking at MRIs and just making sure that there's nothing going on that would be surprising.

所以我認為我們可能仍處於該試驗的安全階段。因此，我認為我們將在 ACTRIMS 中尋找更多安全資訊。也許當我們使用 ECTRIMS 時，我們應該能夠獲得一些額外的功效。再說一遍，它是單臂的，所以功效資訊將非常簡單，查看 MRI 並確保沒有發生任何令人驚訝的事情。

Okay. That's really helpful. Thank you. And then in terms of your plans for BRIUMVI outside of the MS opportunity, can you help us think about how you prioritize the different indications that you are potentially looking at?

好的。這真的很有幫助。謝謝。然後，就您在 MS 機會之外的 BRIUMVI 計劃而言，您能否幫助我們考慮如何優先考慮您可能關注的不同適應症？

Yeah. I mean, I think -- look, we want to get started probably somewhere in the RA Lupus arena with it. I can't promise that that's what's going to happen, but we do think that there's an interesting opportunity. It also will dovetail nicely as we look to get azer-cel and some of those indications as well. There's a nice synergy of clinical resources, so that's an angle that we're looking at, but I can't promise as the year goes on. We may have additional thoughts and we may start someplace else.

是的。我的意思是，我想——看，我們可能想在 RA 狼瘡領域的某個地方開始使用它。我不能保證這將會發生，但我們確實認為這是一個有趣的機會。當我們希望得到 azer-cel 和其中一些適應症時，它也會很好地吻合。臨床資源有很好的協同作用，所以這是我們正在考慮的角度，但隨著時間的推移，我無法保證。我們可能有更多的想法，我們可能會從其他地方開始。

But we do believe that BRIUMVI is designed well for large market indications and right behind it, azer-cel is designed for the more smaller, sicker patient populations, potentially within the same indications.

但我們確實相信 BRIUMVI 專為大型市場適應症而設計，緊隨其後，azer-cel 專為更小、病情更重的患者群體而設計，可能屬於相同的適應症。

Okay. Great. And then lastly, in terms of the recent patents that you announced, can you provide us some more detail in terms of what they cover and providing the protection after, was it 2042?

好的。偉大的。最後，就您最近宣布的專利而言，您能否向我們提供更多有關它們涵蓋的內容以及在 2042 年之後提供保護的詳細資訊？

Yeah. I mean, there's a lot of detail in those patents, but I think the sum in some sense is that in addition to a new composition of matter patent that covers the glycosylation profile of BRIUMVI plus some use patents within that, we feel good about the 2042 patent protection. So we feel that we've got a really nice runway here, but the forms are issued, they are out there. People can read them. But the overriding concept is that it's a composition of matter plus some use patents. 2042 is a nice new place for our exclusivity to run to.

是的。我的意思是，這些專利中有很多細節，但我認為從某種意義上說，總和是，除了涵蓋 BRIUMVI 糖基化特徵的新物質組合物專利以及其中的一些使用專利外，我們對2042 專利保護。所以我們覺得我們這裡有一條非常好的跑道，但是表格已經發出了，它們就在那裡。人們可以閱讀它們。但最重要的概念是它是物質的組合物加上一些使用專利。 2042 是我們的專屬跑去的一個不錯的新地方。

Okay. Thanks a lot.

好的。多謝。

Eric Joseph, JPMorgan.

艾瑞克‧約瑟夫，摩根大通。

Hi, guys. This is Noah, on for Eric. Thanks for taking our question. Our question is with regard to subcu BRIUMVI? How important to drive uptake would it be to demonstrate efficacy via relapse rate compared to demonstrating comparability on bioequivalence? Thanks.

嗨，大家好。這是諾亞，替艾瑞克發言。感謝您提出我們的問題。我們的問題是關於 subcu BRIUMVI？與證明生物等效性的可比較性相比，透過復發率證明療效對於推動吸收有多重要？謝謝。

So the current competitor that's moving from their IV to subcu did a bioequivalence study. We're hoping that we'll be able to follow a similar pathway. So I don't think we're going to need to do a full efficacy study to bring the subcu forward. But that will be definitely subject to more conversations with the FDA. But as of now, the competitor subcu that's moving from IV conducted a bioequivalence study and we think that's an appropriate pathway.

因此，目前從 IV 轉向 subcu 的競爭對手進行了生物等效性研究。我們希望能夠走類似的路。因此，我認為我們不需要進行全面的功效研究來推動 subcu 的發展。但這肯定需要與 FDA 進行更多對話。但截至目前，從 IV 轉向的競爭對手 subcu 進行了生物等效性研究，我們認為這是一個合適的途徑。

Thank you.

謝謝。

You got it.

你說對了。

Prakhar Agrawal, Cantor Fitzgerald.

普拉哈·阿格拉沃爾，坎托·菲茨杰拉德。

Hi. Good morning and congrats on the progress. And thanks for taking my question. So number one, Adam, you said 1Q is tracking at the top end of the guidance range. So maybe if you can give some more details on the January and February trends. Where is the demand growth coming from in terms of patient segments, as well as physician segments, academic versus community?

你好。早上好，祝賀取得的進展。感謝您提出我的問題。第一，亞當，你說 1Q 正在追蹤指導範圍的上限。也許您可以提供有關一月和二月趨勢的更多詳細資訊。病患群、醫師群、學術界與社群的需求成長來自哪裡？

Yeah. Hi, Prakhar. Thanks for the question. I'm not going to get into too many details beyond what I said in the prepared remarks. We got off to a really strong start to the quarter. And as I said, we're feeling really good about our guidance to the higher end of that range, and then any other details we'll discuss on the next quarter call.

是的。嗨，普拉哈爾。謝謝你的提問。除了我在準備好的發言中所說的內容之外，我不會透露太多細節。我們本季的開局非常強勁。正如我所說，我們對該範圍高端的指導感到非常滿意，然後我們將在下個季度的電話會議上討論任何其他細節。

Got it. And do you have a sense of what's the split of academic courses, community patient segments for BRIUMVI, and how do you expect that to trend over time?

知道了。您是否了解 BRIUMVI 的學術課程、社區患者群體的劃分？您預計這種情況隨著時間的推移會如何發展？

Sure. So in the beginning of the year, as I mentioned, it was probably 60-40 private practice to academics. In the most recent quarters, it's more 50-50 academic to private practice. And we are seeing, as I mentioned in the remarks, growth coming from academic centers in the latter half of the year and especially in the fourth quarter.

當然。因此，正如我所提到的，今年年初，學術界可能有 60-40 名私人執業者。最近幾個季度，從學術到私人診所的數量增加了 50-50 人。正如我在發言中提到的，我們看到下半年，特別是第四季學術中心的成長。

Got it. And lastly, what percentage of patients who are getting a prescription actually end up getting the infusion? Do you have any additional details on the trend there? And what's the time lag between getting a prescription to getting an infusion right now, and how does it track relative to Ocrevus?

知道了。最後，獲得處方的患者中實際最終接受輸液的比例是多少？您有關於那裡趨勢的更多詳細資訊嗎？現在取得處方與接受輸液之間的時間間隔是多少？相對於 Ocrevus 的追蹤情況如何？

Yeah. So the conversion rate, we have it's still pretty early, and we have not given a number on that. It's encouraging, but we haven't given a specific number. Perhaps in future calls, we'll look at it, but we still think it's very early to be giving that number. And then Prakhar, can you repeat the second part of that question?

是的。因此，就轉換率而言，我們還處於早期階段，我們還沒有給出具體數字。這是令人鼓舞的，但我們沒有給出具體數字。也許在未來的電話會議中，我們會考慮這個問題，但我們仍然認為現在給出這個數字還為時過早。然後普拉哈爾，你能重複這個問題的第二部分嗎？

Right. So what's the time lag between a prescription and getting the infusion, and how does that trend versus Ocrevus?

正確的。那麼，開處方和接受輸液之間的時間間隔是多少？與 Ocrevus 相比，這一趨勢如何？

Yeah. So I think what I've said in the past, it's about a six-week timeframe from enrollment into the hub into the first infusion, approximately. And from what we understand and from what we -- it's very similar to what you see with Ocrevus. There are a lot of things you can control in that process, and there's things that are outside your control. We continue to see a trend in the direction, we continue to shorten it over time, and so we'd like to see that trend, and we think it's very much in line with what's the competitor product.

是的。所以我想我過去說過，從註冊到中心到第一次輸注大約需要六週的時間。根據我們的理解和我們的了解，這與您在 Ocrevus 身上看到的非常相似。在這個過程中，有很多事情是你可以控制的，也有很多事情是你無法控制的。我們繼續看到這個方向的趨勢，隨著時間的推移，我們繼續縮短它，所以我們希望看到這種趨勢，我們認為它與競爭對手的產品非常一致。

Thank you. And Congrats on the quarter.

謝謝。恭喜本季。

Thanks.

謝謝。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley 證券。

Thank you so much. This is actually William Wood, on for Mayank Mamtani. Congratulations on the past year and thank you for taking our questions.

太感謝了。這實際上是威廉·伍德（William Wood），代表 Mayank Mamtani。恭喜過去的一年，感謝您回答我們的問題。

In terms of the cash and the OpEx burn for 2024, how should we be thinking about the spend allocation between your trials and what's been factored so far into the subcu trial? And then additionally, on the subcu trial, do you have any view of frequency of administration or the kind of device that you'll be using for the formulation? And then one follow-up. Thank you.

就 2024 年的現金和營運支出消耗而言，我們應該如何考慮試驗之間的支出分配以及迄今為止 subcu 試驗中考慮的因素？另外，在 subcu 試驗中，您對給藥頻率或配方中使用的設備類型有什麼看法嗎？然後是一個後續行動。謝謝。

Yeah, so on the subcu, we don't know yet in terms of the frequency of dosing. I think part of that is just going to be let's look at what the conversion is between the two from IV to subcu, and from there we'll be able to design the appropriate dosing interval.

是的，所以在 subcu 上，我們還不知道給藥頻率。我認為其中一部分是讓我們看看兩者之間從 IV 到 subcu 的轉換是什麼，然後我們就能夠設計適當的給藥間隔。

Our goal, obviously, we know what the goalposts are. We've got once a month from one of the subcu products, and the other is once every six months with a pretty clunky product, as far as we can tell and so somewhere in between we think we'd be very successful. So we're going to try to get there. We won't know if we can until we put the material into people and see how it does and see how they react to it.

顯然，我們的目標是，我們知道球門柱是什麼。我們每個月都會使用一種 subcu 產品，而另一種則是每六個月使用一種相當笨重的產品，據我們所知，因此我們認為介於兩者之間的產品會非常成功。所以我們將努力實現這一目標。我們不知道是否可以，直到我們將這些材料放入人們體內，看看它的效果如何，看看他們對此有何反應。

Alright. And on the OpEx guidance, obviously we've guided $250 million in OpEx for ‘24. We haven't provided a detailed breakdown of how that shakes out, but everything that Mike and the team discussed today is obviously included in that $250 million guidance number.

好吧。在營運支出指引方面，顯然我們已經指導 24 月的營運支出為 2.5 億美元。我們尚未詳細說明這一情況如何發生，但麥克和團隊今天討論的所有內容顯然都包含在 2.5 億美元的指導數字中。

Appreciate that. And then just one last question. You obviously reported multiple new patents providing protection in the 2042, including COM as you just noted, as well as the recent launch in the EU. How should we be thinking about this in terms of potential external parties viewing these events and maybe spurring additional interest in TG?

感謝。最後一個問題。您顯然報告了 2042 年提供保護的多項新專利，包括您剛才提到的 COM，以及最近在歐盟推出的專利。我們應該如何考慮潛在的外部各方觀看這些事件並可能激發對 TG 的額外興趣？

Yeah, our goal is to build our business. We're not too worried about external parties. I think if you are referring to external parties being investors, I would hope they'd be updating their models to understand the significance of patent protection through 2042 and what that means to the overall NPV of the SAP. Other outside parties I'm not too worried about.

是的，我們的目標是建立我們的業務。我們不太擔心外部各方。我認為，如果您指的是作為投資者的外部各方，我希望他們能夠更新模型，以了解 2042 年之前專利保護的重要性以及這對 SAP 的整體 NPV 意味著什麼。我不太擔心其他外在聚會。

I appreciate that. And thank you for taking our questions.

我很感激。感謝您回答我們的問題。

Great. Thank you.

偉大的。謝謝。

Thank you. At this time, I'd like to turn the floor back over to Mr. Weiss for closing comments.

謝謝。現在，我想把發言權交還給韋斯先生結束發言。

Great. And thank you. And again, thanks to everyone for joining us this morning. As reported, we had a great launch year, and year two while early is taking shape, and we're excited about our target guidance for this year of $220 million to $260 million in US net sales revenue.

偉大的。謝謝你。再次感謝大家今天早上加入我們。根據報道，我們的推出年表現出色，而第二年的早期階段也已初具規模，我們對今年美國淨銷售收入 2.2 億至 2.6 億美元的目標指導感到興奮。

Our pipeline and lifecycle management activities are in full swing and believe these activities could translate into significant future value for TG, and our recent patent issuance will ensure a long runway to explore the full potential of BRIUMVI.

我們的管道和生命週期管理活動正在如火如荼地進行，相信這些活動可以為 TG 帶來巨大的未來價值，而我們最近頒發的專利將確保有一個漫長的跑道來探索 BRIUMVI 的全部潛力。

Finally, I want to thank again the whole TG team for their dedication to serving the MS community and for their incredible efforts on behalf of TG. Hope everyone has a very nice day.

最後，我要再次感謝整個 TG 團隊為 MS 社區服務的奉獻精神以及他們為 TG 所做的令人難以置信的努力。希望每個人都有美好的一天。

Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines at this time or log off the webcast and enjoy the rest of your day.

女士們、先生們，感謝您的參與。今天的活動到此結束。此時您可以斷開線路或退出網路廣播並享受剩下的一天。