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Operator
Operator
Greetings, and welcome to the TG Therapeutics Third Quarter Earnings Update Call.
您好,歡迎參加 TG Therapeutics 第三季財報更新電話會議。
(Operator Instructions) As a reminder, this conference is being recorded.
(操作員指示)謹此提醒,本次會議正在錄製中。
It is now my pleasure to introduce your host, Jenna Bosco. Thank you, Jenna. You may begin.
現在我很高興向大家介紹你們的主持人珍娜‧博斯科 (Jenna Bosco)。謝謝你,珍娜。你可以開始了。
Jenna Bosco - SVP of Corporate Communications
Jenna Bosco - SVP of Corporate Communications
Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the third quarter of 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 2023 年第三季財務業績的是我們的董事長兼執行長 Michael Weiss; Adam Waldman,我們的首席商業化長;以及我們的財務長 Sean Power。
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。 Adam 將分享我們商業化工作的最新情況,Sean 將概述我們的財務業績,然後將電話轉交給營運商以開始問答環節。
Before we begin, I'd like to remind everyone that we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected regulatory milestones, revenue guidance, clinical development plans and expectations for our future -- 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 filings.
在開始之前,我想提醒大家,我們將做出 1995 年《私人證券訴訟改革法案》含義內的前瞻性聲明。這些前瞻性聲明包括有關我們預期未來營運和財務業績的聲明,包括銷售業績、預計監管里程碑、收入指導、臨床開發計劃以及對我們未來的預期——對於我們銷售的產品。 TG 警告說,這些前瞻性陳述存在風險,可能導致我們的實際結果與所示結果有重大差異。可能影響 TG Therapeutics 營運的因素包括我們向 SEC 提交的文件中可以找到的各種風險因素。
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 statements. This conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where it will be available for the next 30 days.
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陳述的義務。本次電話會議正在錄製並在 TG 網站 www.tgtherapeutics.com 上進行音訊重播,並將在未來 30 天內提供。
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。
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Thanks, Jenna, and good morning, everyone, and thanks for joining us on today's call. It was another good quarter for TG, and I'm happy to share that our net revenue for the third quarter was $166 million, which includes $140 million that we received as an upfront licensing fee from our ex U.S. partner, and also includes over $25 million of Briumvi net sales in the U.S.
謝謝珍娜,大家早安,謝謝您參加今天的電話會議。對於TG 來說,這又是一個不錯的季度,我很高興地告訴大家,我們第三季度的淨收入為1.66 億美元,其中包括我們從前美國合作夥伴那裡收到的1.4 億美元預授權費,還包括超過25 美元百萬 Briumvi 在美國的淨銷售額
Today, I am pleased with the launch and our team's execution of our launch strategy would be an understatement. We continue to outperform our internal expectations and all external revenue expectations set at or prior to our launch. I believe we're in a great position to close out the year strong, and I'm excited for the next year and for the future of Briumvi and TG.
今天,我對發布感到很高興,我們團隊對發布策略的執行是輕描淡寫的。我們繼續超越我們的內部預期以及我們推出時或之前設定的所有外部收入預期。我相信我們處於有利位置,能夠強勁地結束這一年,我對明年以及 Briumvi 和 TG 的未來感到興奮。
Just to remind everybody, Briumvi is the first and only anti-CD20 monoclonal antibody approved to treat patients with relapsing forms of multiple sclerosis that can be administered in the 1-hour fusion twice per year following the starting dose. In clinical trials, Briumvi provided robust efficacy with a safety profile consistent with what is expected of the CD20 class. It's worth noting that while all anti-CD20s target the same protein, they are not all created the same. Epitope binding and potency of that binding as well as our ability to engage immunofactor cells are different. And we're seeing these differences begin to resonate amongst health care providers.
只是提醒大家,Briumvi 是第一個也是唯一一個被批准用於治療復發性多發性硬化症患者的抗 CD20 單株抗體,可以在起始劑量後每年兩次進行 1 小時融合給藥。在臨床試驗中,Briumvi 提供了強大的療效,其安全性符合 CD20 類別的預期。值得注意的是,雖然所有抗 CD20 都針對相同的蛋白質,但它們的產生方式並不相同。表位結合和該結合的效力以及我們與免疫因子細胞結合的能力是不同的。我們看到這些差異開始在醫療保健提供者中引起共鳴。
Putting the whole package together, we see Briumvi as a differentiated anti-CD20 with best-in-class attributes and believe BRIUMVI's differentiated profile has supported our early and meaningful market share gains. I don't need to remind you that we're only in our second full quarter of sales. So still very early days here for our Briumvi launch, and we believe that we are well positioned for future share gains, ultimately driving us toward our goal to be the #1 prescribed anti-CD20 based on dynamic market share.
將整個方案放在一起,我們將 Briumvi 視為具有一流屬性的差異化抗 CD20,並相信 BRIUMVI 的差異化特徵支持了我們早期有意義的市場份額成長。我不需要提醒您,我們剛剛進入第二個完整季度的銷售。因此,我們的 Briumvi 發布還處於早期階段,我們相信我們已經為未來的份額增長做好了充分準備,最終推動我們實現成為基於動態市場份額的排名第一的處方抗 CD20 藥物的目標。
I'd like to spend a few minutes talking about the recent ECTRIMS conference in Milan. ECTRIMS is the premier global MS Conference, and TG had a significant presence there this year. For me personally, it was great to interact with many health care providers and the real-world feedback was overwhelmingly positive. It was really gratifying to hear anecdotes about the tolerability and convenience people experiencing with the use of Briumvi, as well as stories about patients that were early depleters on other anti-CD20s and are now doing well on Briumvi.
我想花幾分鐘談談最近在米蘭舉行的 ECTRIMS 會議。 ECTRIMS 是首屈一指的全球 MS 會議,TG 今年在該會議上發揮了重要作用。就我個人而言,與許多醫療保健提供者互動非常高興,並且現實世界的反饋非常積極。聽到人們使用 Briumvi 體驗到的耐受性和便利性的軼事,以及早期服用其他抗 CD20 藥物的患者現在服用 Biumvi 情況良好的故事,真的很令人欣慰。
In addition to interacting with the health care providers at the conference, we had the opportunity to present additional exploratory analysis from the ULTIMATE I and II Phase III trials of Briumvi in relapsing forms of MS as well as the first data from our ENHANCE Phase IIIb trial, evaluating patients who switch from another IV anti-CD20 therapy to Briumvi. One of the goals of this trial is to understand the safety profile of a patient switching from another IV CD20 to Briumvi without the need for the 150-milligram starting dose as well as to evaluate the speed at which the first infusion before 450-milligram dose may be given safely.
除了在會議上與醫療保健提供者互動外,我們還有機會介紹Briumvi 針對復發型多發性硬化症的ULTIMATE I 和II III 期試驗的其他探索性分析,以及我們的ENHANCE IIIb 期試驗的首批數據,評估從另一種 IV 抗 CD20 療法轉為 Briumvi 的患者。該試驗的目標之一是了解患者在不需要 150 毫克起始劑量的情況下從另一種 IV CD20 轉為 Briumvi 的安全性,以及評估 450 毫克劑量之前第一次輸注的速度可以安全地給予。
The early data presented was very encouraging, demonstrating in 12 patients that we could safely skip the 150-milligram introductory dose and go straight to the 450-milligram dose. In the first cohort, that was given as a 2-hour infusion, and demonstrated there were no infusion-related reactions reported nor any dose interruptions or delays.
早期提供的數據非常令人鼓舞,在 12 名患者中證明我們可以安全地跳過 150 毫克的初始劑量,直接使用 450 毫克的劑量。在第一組中,進行了 2 小時的輸注,結果顯示沒有報告輸注相關反應,也沒有任何劑量中斷或延遲。
The second cohort is now enrolling and is evaluating the 450-milligram dose administered in the ordinary 1-hour infusion. Again, without the need for the 150-milligram introductory dose and we look forward to sharing more data from this trial next year.
第二組現在正在招募並正在評估在普通 1 小時輸注中施用的 450 毫克劑量。同樣,不需要 150 毫克的初始劑量,我們期待明年分享該試驗的更多數據。
Interestingly, about 60% of the patients who entered this study, reported to have experienced a wearing off effect or what some people refer to as the crap gap while on their prior IV CD20. So that's something we're going to continue to look out for. While we're in Milan, we also had the opportunity to meet our colleagues from Neuraxpharm, our ex-U.S. partner. As you may recall, in June, Briumvi was approved in the European Union to treat adult patients with relapsing forms of MS who have active disease defined by clinical or imaging features.
有趣的是,大約 60% 參與這項研究的患者表示,在先前的 IV CD20 治療中經歷了逐漸消失的效果,或者有些人稱之為「垃圾間隙」。所以這是我們將繼續關注的事情。在米蘭期間,我們還有機會見到了來自 Neuraxpharm(我們的前美國公司)的同事。夥伴。您可能還記得,今年 6 月,Briumvi 在歐盟獲得批准,用於治療患有復發性多發性硬化症的成年患者,這些患者的臨床或影像學特徵為活動性疾病。
Our team has been working closely with the Neuraxpharm team and we continue to be confident in their ability to bring Briumvi to the market in Europe. With their extensive experience in the CNS space, their broad presence in all major European countries and an extensive and growing team dedicated to the Briumvi launch, we believe Briumvi is positioned for success in Europe. We are anxiously awaiting the Briumvi launch, which we believe is still on track for early 2024.
我們的團隊一直與 Neuraxpharm 團隊密切合作,我們仍然對他們將 Briumvi 推向歐洲市場的能力充滿信心。憑藉他們在 CNS 領域的豐富經驗、在歐洲所有主要國家的廣泛影響力以及致力於 Briumvi 發布的龐大且不斷壯大的團隊,我們相信 Briumvi 已做好在歐洲取得成功的準備。我們正在焦急地等待 Briumvi 的發布,我們相信它仍有望在 2024 年初發布。
We are also happy to share that we just received approval for Briumvi in the United Kingdom. This is another exciting step forward for Briumvi and for MS patients in the U.K. looking for a new treatment alternative. As we look forward, we are evaluating additional potential indications for Briumvi and our pipeline candidates as well as new product opportunities in MS and autoimmune diseases.
我們也很高興地告訴大家,我們剛剛在英國獲得了 Briumvi 的批准。對於 Briumvi 和英國尋求新治療替代方案的多發性硬化症患者來說,這是另一個令人興奮的進步。展望未來,我們正在評估 Briumvi 和我們的候選產品的其他潛在適應症,以及 MS 和自體免疫疾病領域的新產品機會。
Also, as I've mentioned before, we're evaluating the suitability of Briumvi as a subcutaneous injection. And we expect to be able to provide an update early next year as to whether we believe we have a suitable subcu formulation that could be brought forward into the clinic. Based on the current anti-CD20 subcu landscape, we do believe there is room for a more convenient, more tolerable option. We continue to view the subcu market as distinct from the IV market and thus as a potentially attractive expansion opportunity for Briumvi.
此外,正如我之前提到的,我們正在評估 Briumvi 作為皮下注射的適用性。我們預計能夠在明年初提供最新消息,說明我們是否相信我們有合適的 subcu 配方可以投入臨床。根據目前的抗 CD20 subcu 情況,我們確實相信有更方便、更耐受的選擇。我們仍然認為 subcu 市場與 IV 市場不同,因此對 Briumvi 來說是一個具有潛在吸引力的擴張機會。
Finally, let me discuss some financial matters. Our CFO, Sean Power, will join us in a bit to provide a more detailed financial update, but I just wanted to discuss some revenue expectations and our cash position. First, with respect to revenue expectations, many of you have witnessed the market effects associated with analysts changing their revenue forecast for Briumvi. Some of those changes have been driven by prior quarter sales but some have been driven by intra-quarter sales reporting from distributors, which despite our warnings about the usefulness of this data, has become a source of confusion and price volatility. To address this, beginning on November 1, our distributors will no longer be sharing distributor-level data with third-party companies.
最後,讓我討論一些財務問題。我們的財務長 Sean Power 將與我們一起提供更詳細的財務更新,但我只想討論一些收入預期和我們的現金狀況。首先,關於收入預期,你們中的許多人都見證了分析師改變 Briumvi 收入預測所帶來的市場影響。其中一些變化是由上一季的銷售推動的,但另一些則是由分銷商的季度內銷售報告推動的,儘管我們對這些數據的有用性提出了警告,但這些變化已成為混亂和價格波動的根源。為了解決這個問題,從 11 月 1 日開始,我們的經銷商將不再與第三方公司分享經銷商層級的資料。
With that, as promised, I'd like to provide some guidance for the fourth quarter of 2023. At this time, we are targeting revenues of approximately $33 million to $37 million. That should put us on target for approximately $82 million to $86 million for our first partial year of sales, which is a bit ahead of the current '23 consensus of $80 million and well above the consensus of $72 million set around the time of our launch.
因此,正如承諾的那樣,我想為 2023 年第四季提供一些指導。目前,我們的目標收入約為 3300 萬至 3700 萬美元。這應該使我們的第一個部分年度銷售額目標約為8200 萬至8600 萬美元,這比當前'23 年的共識8000 萬美元提前了一點,也遠高於我們推出時設定的7200 萬美元的共識。
Now turning to our cash position. As of the end of the third quarter, we had approximately $229 million in cash. As I mentioned on our last quarterly call as our revenues grow, and we continue to operate with a relatively stable OpEx, our cash burn is trending down. And from here, we believe we have a reasonable line of sight to profitability in the near term. All in all, we feel really confident with our cash position and our ability to execute on our business plan.
現在轉向我們的現金狀況。截至第三季末,我們擁有約 2.29 億美元現金。正如我在上個季度的電話會議上提到的,隨著我們的收入成長,並且我們繼續以相對穩定的營運支出運營,我們的現金消耗呈下降趨勢。從這裡開始,我們相信我們對短期內的獲利能力有合理的預期。總而言之,我們對我們的現金狀況和執行業務計劃的能力充滿信心。
With that, let me turn the call over to our Chief Commercialization Officer, Adam Waldman, who will provide more detailed information about our Briumvi launch. Adam?
接下來,讓我將電話轉給我們的首席商業化長 Adam Waldman,他將提供有關我們的 Briumvi 發布的更多詳細資訊。亞當?
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Thank you, Mike, and good morning, everyone. I'm pleased to be with you today to share another strong quarter of execution for our Briumvi launch. We continue to deliver results that exceed expectations and set the foundation for future success.
謝謝你,麥克,大家早安。我很高興今天能與大家分享我們推出的 Briumvi 的另一個強勁季度執行情況。我們繼續提供超越預期的成果,並為未來的成功奠定基礎。
The third quarter net sales for Briumvi were $25.1 million, representing 57% growth quarter-over-quarter. This growth was primarily driven by increases in new patient infusions, reduced logistical barriers and continued steady growth in patient demand as represented by over 900 prescriptions into our hub. That brings our launch to date total to approximately 2,200 new patient scripts. And as we have mentioned in the past, we believe this figure is capturing about 80% to 90% of the total new Briumvi scripts written.
Briumvi 第三季淨銷售額為 2,510 萬美元,季增 57%。這一增長主要是由於新患者輸液的增加、後勤障礙的減少以及患者需求的持續穩定增長(以我們中心的 900 多個處方為代表)。這使得我們迄今為止推出的新患者腳本總數達到約 2,200 個。正如我們過去提到的,我們相信這個數字佔新編寫的 Briumvi 腳本總數的 80% 到 90% 左右。
As Mike mentioned, with approximately 40,000 MS patients starting at CD20 each year in the U.S., our patient accumulation remains on target. And based on scripts to our hub, we are now capturing a nice portion of the new anti-CD20 patient share at this early point in our launch. And we do believe the CD20 market is growing and will continue to expand going forward.
正如 Mike 所提到的,美國每年約有 4 萬名從 CD20 開始的多發性硬化症患者,我們的患者累積仍達到目標。根據我們中心的腳本,我們現在在發布的早期階段捕獲了新的抗 CD20 患者份額的很大一部分。我們確實相信 CD20 市場正在成長並將繼續擴大。
Additionally, in Q3, we saw for the first time patients returning for their week 24 infusions, and we anticipate the number of week 24 infusions will increase significantly in Q4 as more patients are expected to return.
此外,在第三季度,我們首次看到患者返回進行第 24 週的輸注,我們預計隨著更多患者返回,第 24 週的輸注次數將在第四季度顯著增加。
From an execution perspective, we remain focused on our initial priorities to drive adoption in the high-volume targeted accounts, provide best-in-class patient support, enable access and educate patients. And we have made great progress across all of these priorities. The cumulative effects of what we've accomplished are certainly helping to drive the momentum we saw from Q2 to Q3, and we expect to see that momentum carry forward into Q4 and into next year.
從執行的角度來看,我們仍然專注於我們的最初優先事項,以推動大容量目標帳戶的採用,提供一流的患者支持,實現訪問和教育患者。我們在所有這些優先事項上都取得了巨大進展。我們所取得的成就的累積效應肯定有助於推動我們從第二季度到第三季度看到的勢頭,我們預計這種勢頭將延續到第四季度和明年。
We continue to believe the Briumvi profile is best-in-class, and will eventually be the IV therapy of choice for the relapsing MS market. BRIUMVI's unique 1-hour infusion every 6 months delivers on patient convenience, reduces health care resource burdens and helps to address the needs of both private practice infusion centers and busy academic centers. The real-world experience with Briumvi continues to grow and the feedback we received is overwhelmingly positive.
我們仍然相信 Briumvi 是同類最佳的,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。 BRIUMVI 獨特的每 6 個月一次的 1 小時輸液為患者帶來了便利,減輕了醫療保健資源負擔,並有助於滿足私人執業輸液中心和繁忙的學術中心的需求。 Briumvi 的實際體驗不斷增長,我們收到的回饋非常正面。
As we continue to progress towards our goal of making Briumvi the go to IV CD20 therapy, there is nothing more valuable than positive physician and nurse and patient experience. We believe their growing experience will help reinforce the differentiation of Briumvi and lead to expanded utilization in the future. Encouragingly, we are seeing increases in both breadth and depth with our prescribers. We are seeing more and more prescribers and centers getting their initial experience with the drug and we are now up to approximately 500 total prescribers at more than 325 centers that have used Briumvi.
隨著我們繼續朝著使 Briumvi 成為 IV CD20 治療首選的目標邁進,沒有什麼比積極的醫生、護士和患者體驗更有價值的了。我們相信,他們的成長經驗將有助於增強 Briumvi 的差異化,並在未來擴大使用率。令人鼓舞的是,我們看到我們的處方醫生在廣度和深度上都在增加。我們看到越來越多的處方者和中心獲得了該藥物的初步經驗,現在超過 325 個中心的大約 500 名處方者已經使用過 Briumvi。
Importantly, the adoption rate at top centers of excellence continues to increase with now 90% of the top 50 centers and 80% of the top 100 centers having utilized Briumvi. Depth is also increasing from early adopters with significant increases in physicians that now have multiple patients on Briumvi. We view increases in repeat users as an important metric as we believe it likely represents a positive experience using the product.
重要的是,頂級卓越中心的採用率持續增加,目前前 50 名中心中的 90% 和前 100 名中心中的 80% 都使用了 Briumvi。早期採用者的深度也在增加,現在有多名患者使用 Briumvi 的醫生顯著增加。我們將重複使用者的增加視為一個重要指標,因為我們認為它可能代表了使用該產品的正面體驗。
We have always known that the process of accessing Briumvi was going to be critical -- a critical success factor for this launch. And we are very pleased with the feedback we've received from customers on their interactions with both our people and our patient support services to date. We are very proud of the patient hub programs that we have built to support patients and our field teams have done a tremendous job engaging with our customers. We believe our efforts here are contributing to the positive experience with Briumvi and building confidence in our organization in general.
我們一直都知道,造訪 Briumvi 的過程至關重要——這是此次發布成功的關鍵因素。我們對客戶迄今為止與我們的員工和患者支援服務互動的回饋感到非常滿意。我們為支持患者而建立的患者中心計劃感到非常自豪,我們的現場團隊在與客戶的互動方面做了巨大的工作。我們相信,我們在這裡所做的努力有助於為 Briumvi 帶來積極的體驗,並在整體上建立對我們組織的信心。
We continue to focus on moving patients from the hub to the infusion as quickly possible -- as possible. And we are seeing improvements here over time. Continued improvement in payer coverage is facilitating our ability to do that. We are now up to 95% coverage for commercial and Medicare lives, exceeding our corporate goal for the year, and we believe this will enhance access to Briumvi moving forward.
我們繼續專注於盡快將患者從中心轉移到輸液處。隨著時間的推移,我們看到了這裡的改進。付款人覆蓋範圍的持續改善正在增強我們做到這一點的能力。現在,我們的商業和醫療保險覆蓋率高達 95%,超出了我們今年的企業目標,我們相信這將進一步提高 Briumvi 的覆蓋率。
In addition, the permanent J-Code has now been loaded in the payer systems and our average selling price has been published, all of which should help build confidence in reimbursement. We have made progress -- we have also made progress in the quarter with major institutions and health systems. We have secured an increased number of institutional formulary wins for Briumvi. And importantly, we have seen our first scripts in infusion this quarter from several of the top academic institutions and highest volume MS centers. We are confident prescribing at these institutions will expand moving forward as they gain more and more experience and fully integrate Briumvi into their systems.
此外,永久 J 代碼現已加載到付款人系統中,我們的平均售價也已公佈,所有這些都將有助於建立報銷信心。我們已經取得了進展——本季度我們在主要機構和衛生系統方面也取得了進展。我們為 Briumvi 贏得了越來越多的機構處方勝利。重要的是,我們已經看到本季度從幾個頂級學術機構和數量最多的 MS 中心注入了我們的第一個腳本。我們相信,隨著這些機構獲得越來越多的經驗並將 Briumvi 完全整合到他們的系統中,這些機構的處方將不斷擴大。
Finally, our research indicates that patients play an important role in selecting their therapy for MS. With that in mind and now that we've made great progress on building awareness with our health care providers and gaining broad insurance coverage, we have significantly increased our patient activation tactics and are starting to see the impacts of those efforts.
最後,我們的研究表明,患者在選擇多發性硬化症治療方法方面發揮重要作用。考慮到這一點,現在我們在提高醫療保健提供者的意識和獲得廣泛的保險覆蓋方面取得了巨大進展,我們顯著增加了患者激活策略,並開始看到這些努力的影響。
In September and October, we generated substantial increases in overall impressions through our digital media efforts and we are already seeing the impact in website visits and increases in patient requests for Briumvi. I can say with certainly -- with certainty that our team has built a strong foundation for success, and we are determined to build upon this.
9 月和 10 月,我們透過數位媒體努力大幅提高了整體印象,並且我們已經看到了網站訪問量的影響以及患者對 Briumvi 的請求的增加。我可以肯定地說,我們的團隊已經為成功奠定了堅實的基礎,我們決心在此基礎上再接再厲。
Going into the fourth quarter, we have solid momentum behind us, 95% coverage in place, decreasing logistical barriers, positive -- growing positive experience with Briumvi and an increasing number of patients coming back for the week 24 infusions.
進入第四季度,我們的勢頭強勁,覆蓋率達到 95%,後勤障礙減少,Briumvi 的積極體驗不斷增加,並且第 24 週輸液的患者數量不斷增加。
We remain confident in the short run, we'll see deepening utilization with our current base, and we'll continue to unlock more and more accounts going forward. We are also confident that in the long term that Briumvi will become the IV CD20 of choice for patients with relapsing forms of MS. We certainly have more work to do but we continue to make progress, and we are ahead of where we thought we'd be at this point and we are extremely motivated to continue to work every day to bring Briumvi to those people living with MS and their families.
我們在短期內仍然充滿信心,我們將看到現有基礎的使用率不斷加深,並且我們將繼續解鎖越來越多的帳戶。我們也相信,從長遠來看,Briumvi 將成為復發性多發性硬化症患者的首選 IV CD20。當然,我們還有更多工作要做,但我們會繼續取得進展,目前我們已經領先於我們的預期,我們非常有動力繼續每天工作,將 Briumvi 帶給那些患有多發性硬化症和他們的家人。
With that, I'll now turn the call over to Sean Power, our CFO.
現在,我將把電話轉給我們的財務長 Sean Power。
Sean A. Power - CFO, Corporate Secretary & Treasurer
Sean A. Power - CFO, Corporate Secretary & Treasurer
Thank you, Adam, and thanks, everyone, for joining us. Earlier this morning, we reported our detailed third quarter 2023 financial results, which can be viewed on the Investors & Media section of our website.
謝謝你,亞當,也謝謝大家加入我們。今天早些時候,我們報告了詳細的 2023 年第三季財務業績,您可以在我們網站的投資者與媒體部分查看該業績。
I'll start today's call by recapping some of the financial highlights from this morning's release. For the third quarter, we are pleased to report total net revenue of approximately $166 million, which is comprised of $25.1 million in Briumvi net product sales and $140 million in license revenue, stemming from the upfront payment for our ex-U.S. commercialization agreement with Neuraxpharm. This brings our total net revenue for the 9-month year-to-date period to approximately $190 million, which includes approximately $49 million in Briumvi net product sales.
我將透過回顧今天上午發布的一些財務亮點來開始今天的電話會議。我們很高興地報告第三季的總淨收入約為 1.66 億美元,其中包括 2,510 萬美元的 Briumvi 淨產品銷售額和 1.4 億美元的授權收入,這些收入來自我們在美國以外地區的預付款。與 Neuraxpharm 簽訂商業化協議。這使得我們今年迄今 9 個月的總淨收入達到約 1.9 億美元,其中包括約 4,900 萬美元的 Briumvi 淨產品銷售額。
On the back of the reported revenues, we were able to report net income in both the 3- and 9-month periods. Net income for the 3-month period was approximately $114 million or $0.73 per share -- per diluted share and net income of $27 million or $0.19 per diluted share for the 9-month period.
根據報告的收入,我們能夠報告 3 個月和 9 個月期間的淨利潤。 3 個月期間的淨利潤約為 1.14 億美元,即每股攤薄收益 0.73 美元;9 個月期間的淨利潤為 2,700 萬美元,即每股攤薄收益 0.19 美元。
Our OpEx during the period has remained well controlled and within previously guided range -- ranges. For the third quarter, our R&D and SG&A operating expenses totaled approximately $48 million and approximately $38 million when excluding noncash compensation. Over the course of the year, we have continued to invest in Briumvi inventory, with approximately $34 million now on our balance sheet, of which $24 million is reflected in the current quarter cash burn.
在此期間,我們的營運支出保持了良好的控制,並在先前指導的範圍內。第三季度,我們的研發和銷售、一般行政費用營運費用總計約為 4,800 萬美元,不包括非現金薪酬時約為 3,800 萬美元。在這一年中,我們繼續投資於 Briumvi 庫存,目前我們的資產負債表上約有 3,400 萬美元,其中 2,400 萬美元反映在本季的現金消耗中。
And finally, from a cash standpoint, we ended the quarter with approximately $229 million in cash, cash equivalents and investment securities. As Mike touched on earlier, we feel comfortable that our existing cash when coupled with modest Briumvi revenue assumptions, provides us with sufficient capital to fund our operations to cash flow positivity.
最後,從現金的角度來看,本季末我們擁有約 2.29 億美元的現金、現金等價物和投資證券。正如 Mike 早些時候提到的,我們感到放心的是,我們現有的現金加上適度的 Briumvi 收入假設,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 back over to the conference operator to begin the Q&A.
現在,我將把電話轉回給會議接線員以開始問答。
Operator
Operator
We will now be conducting a question-and-answer session.
我們現在將進行問答環節。
(Operator Instructions) Our first question is from Ed White with H.C. Wainright.
(操作員說明)我們的第一個問題來自 Ed White 和 H.C.溫賴特。
Edward Patrick White - MD of Equity Research & Senior Healthcare Analyst
Edward Patrick White - MD of Equity Research & Senior Healthcare Analyst
Congratulations on a great quarter.
恭喜您度過了一個美好的季度。
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Thanks, Ed.
謝謝,艾德。
Edward Patrick White - MD of Equity Research & Senior Healthcare Analyst
Edward Patrick White - MD of Equity Research & Senior Healthcare Analyst
So Mike, I just wanted to get your thoughts on the anti-CD20 market penetration within the overall MS treatment landscape and your thoughts on infusion versus subcu injections going forward?
Mike,我只是想了解您對整個 MS 治療領域中抗 CD20 市場滲透率的看法,以及您對未來輸注與 subcu 注射的看法?
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Yes. So I'll do a little bit about subcu. I'll let Adam take the first half of that question about the growing CD20 market.
是的。所以我會做一些關於 subcu 的事情。我將讓 Adam 回答關於不斷增長的 CD20 市場的問題的前半部分。
But yes, I mean my impression of the infusion versus subcu market, the infusion market is growing but the overall market is probably growing faster, and that's probably because the subcu market is expanding into areas in which the IV market never penetrated. So I think we're seeing subcu penetrating out into more general neurologists. Again, it's centers that probably were not already using or very limited use potentially of IV CD20.
但是,是的,我的意思是我對輸液與 subcu 市場的印象,輸液市場正在成長,但整體市場可能會成長得更快,這可能是因為 subcu 市場正在擴展到 IV 市場從未滲透的領域。所以我認為我們正在看到 subcu 滲透到更普通的神經科醫生。同樣,這些中心可能尚未使用或使用 IV CD20 的可能性非常有限。
So we think that the IV market will continue to grow. Our focus continues to be on centers that are involved in IV therapy. And I think we're leaving for the bigger players here to work on the general neurologists. And as they expand, they're using to CD20 and into subcu and potentially into IV, we could then tag along and introduce Briumvi in those centers.
因此我們認為 IV 市場將持續成長。我們的重點仍然是參與靜脈注射治療的中心。我認為我們將離開這裡,讓更大的參與者從事普通神經科醫生的工作。隨著他們的擴張,他們正在使用 CD20 和 subcu,並可能進入 IV,然後我們可以跟隨並在這些中心引入 Briumvi。
Adam, do you want to talk about CD20 as a part of the overall MS treatment landscape?
Adam,您想談談 CD20 作為 MS 整體療程格局的一部分嗎?
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Sure. Yes. So Ed, we estimate about 80,000 patients is about the dynamic market. Those are patients that are either initiating a new treatment for the first time or they are switching from another therapy in a given year. And about 50% of those or about 40,000 patients are going on a CD20. And we believe, as Mike said, that market is -- the CD20 market is growing and expanding but that's where we get -- that's our assumption for the MS market and where CD20s play in that market.
當然。是的。 Ed,我們估計大約有 80,000 名患者是一個充滿活力的市場。這些患者要不是第一次開始新的治療,就是在某一年從另一種治療轉向。其中約 50% 或約 40,000 名患者正在接受 CD20 治療。正如麥克所說,我們相信這個市場 - CD20 市場正在成長和擴大,但這就是我們所得到的 - 這是我們對 MS 市場以及 CD20 在該市場中發揮作用的假設。
Edward Patrick White - MD of Equity Research & Senior Healthcare Analyst
Edward Patrick White - MD of Equity Research & Senior Healthcare Analyst
Okay. And perhaps you can comment on -- you mentioned the ENHANCE trial. I'm just wondering if we can get your thoughts on the real-world number of patients that are switching from other CD20s to Briumvi?
好的。也許你可以評論一下——你提到了 ENHANCE 試驗。我只是想知道我們是否可以了解您對從其他 CD20 轉向 Briumvi 的實際患者數量的看法?
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Sure. Adam, can you take that one?
當然。亞當,你能拿走那個嗎?
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Yes. So we have seen -- I think we've said before on this call that we did not expect a lot of patients to be switching from either IV CD20 or subcu CD20. That was not part of our initial estimates or thought process but we have seen it and we've said, actually, it surprised us at how much we are seeing. And I will say that a lot of the reasons that we hear from physicians as to why they are doing it is -- one is the 1-hour shorter infusion. Of course, that's the most often referred to attribute of Briumvi that causes a switch.
是的。所以我們已經看到——我想我們之前在這次電話會議上說過,我們預計不會有很多患者從 IV CD20 或 subcu CD20 轉換。這不是我們最初的估計或思考過程的一部分,但我們已經看到了它,我們說過,實際上,我們對所看到的數量感到驚訝。我想說的是,我們從醫生那裡聽到的很多原因是——其中之一是輸液時間縮短了 1 小時。當然,這是 Briumvi 最常提到的導致切換的屬性。
But we also increasingly hear about this wearing off effect or crap gap that it's called by patients, where there's an early wearing off effect with other CD20s, and physicians are willing to get Briumvi a try to see if they can get a better response with Briumvi. So we're seeing that and I guess it has surprised us at how much we are seeing.
但我們也越來越多地聽到患者所說的這種磨損效應或廢話間隙,其他 CD20 會出現早期磨損效應,醫生願意嘗試 Biumvi,看看他們是否可以用 Briumvi 獲得更好的反應。所以我們看到了這一點,我想我們對所看到的數量感到驚訝。
Edward Patrick White - MD of Equity Research & Senior Healthcare Analyst
Edward Patrick White - MD of Equity Research & Senior Healthcare Analyst
And perhaps my last question would just be how much free drug through Quick Start -- the Quick Start program did you see this quarter? And what are your expectations for that going forward?
也許我的最後一個問題是,本季您透過「快速啟動」—「快速啟動」計畫獲得了多少免費藥物?您對此有何期望?
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Sure. Yes, free goods remained at around 20% this quarter, very similar to last quarter. The majority of that is Quick Start. So we do expect now that we have 95% coverage in place, that we will see a drop in free goods going into the fourth quarter and continuing forward. So I can't exactly tell you how much of a drop but we do think it will be less than what we're seeing in the first 3 quarters so far.
當然。是的,本季免費商品的比例保持在 20% 左右,與上季非常相似。其中大部分是快速入門。因此,我們確實預計,現在我們已經實現了 95% 的覆蓋率,我們將看到免費商品的下降進入第四季度並持續下去。因此,我無法準確告訴您下降了多少,但我們確實認為下降幅度將小於迄今為止前三個季度的下降幅度。
Operator
Operator
Our next question is from Roger Song with Jefferies.
我們的下一個問題來自 Jefferies 的 Roger Song。
Roger Song - Equity Associate
Roger Song - Equity Associate
Great. And my congrats for the good quarter. A couple of questions from us. Yes -- the first question may be a drill down for the patient composition you have been seeing for your -- for the patient to use Briumvi. So like how many of them are -- what's the breakdown between new patient versus switch patients and the renewed patients? Because I believe you start to see some renewed patients. But maybe more interesting is how the recent month in 4Q, you start to see those patients?
偉大的。我祝賀這個季度的良好表現。我們有幾個問題。是的,第一個問題可能是深入了解您所看到的患者成分,以便患者使用 Briumvi。那麼,他們中有多少人——新患者與轉換患者以及新患者之間的細分是什麼?因為我相信你開始看到一些新的病人。但也許更有趣的是最近一個月的第四季度,您是如何開始看到這些患者的?
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Yes. Adam, you want to tackle that one? So it's -- you're saying the composition of new versus returning patients for their infusions?
是的。亞當,你想解決這個問題嗎?所以,你是說新病人和回訪病人輸液的成分?
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Is that the question, Roger? Or is it visit how many new versus switch patients? Can you just clarify the question before I answer.
羅傑,是這個問題嗎?或是看訪多少新患者與轉換患者?在我回答之前你能先澄清一下問題嗎?
Roger Song - Equity Associate
Roger Song - Equity Associate
Yes, sure. So basically, we have 3 categories of the patients. New patients, new to the CD20, switch from other CD20 and also the renew for the Briumvi patient. Maybe just qualitatively how you will characterize those 3 categories?
是的,當然。基本上,我們有 3 類患者。新患者,即新使用 CD20 的患者,從其他 CD20 更換,並且更新了 Briumvi 患者。也許只是定性地描述這 3 個類別的特徵?
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Got it. Sorry, I misunderstood you. Go ahead, Adam.
知道了。抱歉,我誤會你了。繼續吧,亞當。
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Sure. So we've seen a nice balance between all those 3 groups, right? So we are seeing a good percentage from new to therapy. We are seeing probably the biggest percentage from switches from non-CD20 and we are seeing a decent amount from -- as I mentioned before, decent and more than expected from existing CD20s. So relatively balanced across those 3 groups, probably a little bit more in the switching from non-CD20 therapy.
當然。所以我們已經看到這 3 組之間取得了很好的平衡,對嗎?所以我們看到從新到治療的比例很高。我們看到的可能是來自非 CD20 的轉換所佔的比例最大,而且我們看到相當多的比例來自——正如我之前提到的,相當多,並且超出了現有 CD20 的預期。因此,這 3 組之間相對平衡,從非 CD20 治療的轉換可能會更多。
Roger Song - Equity Associate
Roger Song - Equity Associate
Got it. And another also related to the revenue question is the -- you report the prescription you're getting and also the revenue. From the prescription to the revenue, what are the key factors to play into the final net revenue, because the prescription you're getting are maybe those patients will have the compliance rate to get -- to fulfill those revenue. And of course, we'll have this free drug and gross to net. Are those are the key factors to convert from prescription to the revenue?
知道了。另一個也與收入相關的問題是——你報告你得到的處方以及收入。從處方到收入,影響最終淨收入的關鍵因素是什麼,因為您獲得的處方可能是那些患者將獲得的合規率——以實現這些收入。當然,我們會得到這種免費的藥物和毛淨值。這些是從處方轉化為收入的關鍵因素嗎?
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Adam, you want to keep going? You're on a roll here.
亞當,你想繼續嗎?你在這裡很順利。
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Sure. Yes. So those are the factors. I would also say it's important to understand that there is a time lag from the hub to the infusion, right? So there is time that goes on from when a patient comes into our hub and when a patient gets infusion. There's also -- you mentioned compliance but there are also -- we know that there are some patients that go into the hub that actually never get to an infusion. So those are the factors in addition to the ones that you mentioned. Yes, that's all I can think of.
當然。是的。這些就是因素。我還想說,重要的是要了解從中心到輸液存在時間滯後,對嗎?因此,從患者進入我們的中心到患者接受輸液,需要一段時間。還有──你提到了依從性,但也有──我們知道有些進入中心的病人其實從未接受過輸液。因此,除了您提到的因素之外,還有這些因素。是的,我只能想到這些。
Does that answer your question, Roger?
這能回答你的問題嗎,羅傑?
Roger Song - Equity Associate
Roger Song - Equity Associate
No, that's great. Okay. Final question, a quick one. Mike, you have the guidance for 4Q and the overall year for 2023. Maybe when you will provide the 2024 revenue guidance? And how should we think about the trajectory from 2023 to 2024?
不,那太好了。好的。最後一個問題,一個快速的問題。麥克,您有第四季和 2023 年全年的指導。也許您什麼時候會提供 2024 年的收入指引?我們該如何思考2023年到2024年的軌跡?
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Yes. Thanks, Roger. So yes, we have not given any guidance on '24 yet. We're still getting our feet wet here and trying to work on how do we produce guidance. So still early days for us in that standpoint. But our goal would be to again, to the extent possible, to try to get some guidance out as early as possible next year. Again, to avoid people trying to guess what it's going to look like. So we are trying to close the information gap.
是的。謝謝,羅傑。所以,是的,我們還沒有就 '24 給任何指導。我們仍在嘗試如何制定指導。從這個角度來看,我們還處於早期階段。但我們的目標是盡可能在明年儘早制定一些指導。再次強調,避免人們試圖猜測它會是什麼樣子。因此,我們正在努力縮小資訊差距。
So again, people don't use sources of information that we don't believe as reliable as what -- at least what we hope we're seeing and looking at is creating the forecast. So yes. So hopefully, we can get something out early next year and give some guidance to get people on the right track.
再說一次,人們不會使用我們認為不可靠的資訊來源——至少我們希望我們看到和關注的是創造預測。所以是的。因此,希望我們能在明年初拿出一些成果,並提供一些指導,讓人們走上正確的道路。
Operator
Operator
Our next question is from Mayank Mamtani with B. Riley Securities.
我們的下一個問題來自 B. Riley Securities 的 Mayank Mamtani。
Mayank Mamtani - MD, Senior Biotech Research Analyst & Group Head of Healthcare
Mayank Mamtani - MD, Senior Biotech Research Analyst & Group Head of Healthcare
Team, congrats also on strong execution. So maybe just continuing on Roger's sort of follow-up questions on understanding prescription volume to revenues. So Adam, when you refer prescription volume, for example, if you have 2 loading doses, is that basically 1 prescription volume? And then the 24-week return patient, is that sort of another prescription number that basically, just from a process standpoint, is that how it works?
團隊,也祝賀他們強大的執行力。因此,也許只是繼續羅傑關於了解處方量與收入的後續問題。那麼 Adam,當您提到處方量時,例如,如果您有 2 個負荷劑量,那麼這基本上是 1 個處方量嗎?那麼 24 週返回的患者,是不是另一個處方編號,基本上,僅從流程的角度來看,就是這樣運作的?
And then sorry if I missed that, did you say the number for your new patient share info within the anti-CD20 class? It looks like you have some mature data now to be able to say what your market share is for new patients?
如果我錯過了,抱歉,您是否說出了抗 CD20 類別中新患者共享資訊的號碼?看起來您現在已經有了一些成熟的數據,可以說明您對新患者的市場佔有率是多少?
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Yes. Mayank, just to be clear, the only number we're reporting is new prescriptions and they're not separate scripts. So we're not reporting week 24 scripts. We're not reporting day 15 scripts. The numbers we're giving you are new scripts for new patients coming into our hub.
是的。 Mayank,需要澄清的是,我們報告的唯一數字是新處方,它們不是單獨的處方。所以我們不會報告第 24 週的劇本。我們不會報告第 15 天的腳本。我們為您提供的數字是針對進入我們中心的新患者的新腳本。
Mayank Mamtani - MD, Senior Biotech Research Analyst & Group Head of Healthcare
Mayank Mamtani - MD, Senior Biotech Research Analyst & Group Head of Healthcare
Super helpful. And then on the new...
超有幫助。然後在新...
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Yes, the market share, yes, I think we're just taking the calculation of 40,000 patients in the year. Approximately it's about 10,000 a quarter. And if you get 900 new into the hub. And again, we're basing that just on folks coming into our hub. That gives you a good sense of the share of the anti-CD20 market that we're getting.
是的,市場份額,是的,我想我們只是以今年40,000名患者來計算。大約是一個季度10,000左右。如果你有 900 個新人進入中心。再說一次,我們只是根據進入我們中心的人來確定這一點。這讓您可以很好地了解我們所獲得的抗 CD20 市場份額。
Mayank Mamtani - MD, Senior Biotech Research Analyst & Group Head of Healthcare
Mayank Mamtani - MD, Senior Biotech Research Analyst & Group Head of Healthcare
Got it. And then your point on the hub to infusion time and percent rate conversion to infusion, like this trend wise, how is that evolving? If you could comment on that. And I don't know if you commented on gross to net, if you could comment on that, too.
知道了。然後,您對輸注時間和輸注轉換百分比的中心的觀點,就像這種趨勢一樣,它是如何演變的?如果你能對此發表評論的話。我不知道你是否對毛網發表了評論,你是否也可以對此發表評論。
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Sure. So as I mentioned in the prepared remarks, we are seeing improvements in time to -- from hub to infusion, which we would expect as insurance coverage gets better. So that's good that we're seeing that and we're doing everything we can to decrease that time as much as possible. There are some things that we can control and there are certainly some things that are outside of our control. But we think that that's an important thing to focus on and we are seeing improvements in that area.
當然。因此,正如我在準備好的發言中提到的那樣,我們看到從中心到輸液的時間有所改善,隨著保險覆蓋範圍的擴大,我們預計會發生這種情況。因此,我們看到這一點是件好事,我們正在盡一切努力盡可能地減少這個時間。有些事情是我們可以控制的,當然有些事情是我們無法控制的。但我們認為這是值得關注的重要事情,我們正在看到該領域的改進。
As far as the gross to net question, yes, I think what we said was in the first quarter, it was 77%. And in Q2, we said it was in line with that. And I think it's a good number to use from a modeling perspectives across the year but we're not going to update the gross demand on a quarterly basis.
至於毛淨比問題,是的,我認為我們所說的是第一季的情況,為 77%。在第二季度,我們表示這與此一致。我認為從全年建模的角度來看,這是一個很好的數字,但我們不會按季度更新總需求。
Mayank Mamtani - MD, Senior Biotech Research Analyst & Group Head of Healthcare
Mayank Mamtani - MD, Senior Biotech Research Analyst & Group Head of Healthcare
Understood. And final question about your sort of guidance, thinking you would give a little bit more color on new versus prior anti-CD20 switch, how should we think about that? And then also baking in the return patients, the 24 week return patients, could you just maybe comment on how to think about 4Q and into first half given what you're seeing?
明白了。關於您的指導的最後一個問題,您認為您會為新的抗 CD20 開關與先前的抗 CD20 開關提供更多的色彩,我們應該如何考慮?然後,考慮到返回的患者,即 24 週返回的患者,考慮到您所看到的情況,您能否評論一下如何思考第四季度和上半年?
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Sure. I think I covered the distribution of patients. I'll give a couple of things to think about with regards to revenue from week 24 infusions. So just a couple of things to think about. One is that and you mentioned this, a patient that starts therapy is going to get that initial loading dose or 150 milligrams followed by 450 milligrams. So that's 4 vials, right? The vials are 150 milligrams each, so that's 4 vials. A patient coming back for week 24 is getting 3 vials, right? So that's a 25% reduction if -- when that patient comes back and just from a revenue standpoint.
當然。我想我已經涵蓋了患者的分佈。關於第 24 週輸注的收入,我將給予一些需要考慮的事項。因此,有幾件事需要考慮。其一,您提到過,開始治療的患者將接受初始負荷劑量,即 150 毫克,然後是 450 毫克。那是 4 瓶,對嗎?每瓶 150 毫克,所以有 4 瓶。第 24 週回來的患者會拿到 3 瓶,對嗎?因此,僅從收入角度來看,如果該患者回來,就會減少 25%。
The other thing that's important to think about just in terms of revenue from repeat versus new is you have to take into account that not everyone will return from week 1 to week 24. We still know what that -- obviously, it's still way too early for us to tell you what we think that, that will be for Briumvi. But we do know that looking at other IV CD20s, that they lose about 15% of patients from drug initiation to their 6-month dosing. And then that drop-off rate seems to decrease at a slower rate from there, right? With the average duration for an IV CD20 seems to be about 5 years and growing. But they do lose about 15%, is our understanding of the data, about 15% from the first infusions to the second infusion, which is the largest drop off. And then as I mentioned, it's sort of even drop from there. So those are 2 things to think about when you're thinking about return revenue. Hopefully, that answers the question.
就重複收入與新收入而言,需要考慮的另一件事是,你必須考慮到,並不是每個人都會從第1 周到第24 週回歸。我們仍然知道這一點- 顯然,現在還為時過早點讓我們告訴你我們對 Briumvi 的看法。但我們確實知道,看看其他 IV CD20,從藥物開始到 6 個月給藥,它們失去了大約 15% 的患者。然後,下降率似乎會以較慢的速度下降,對嗎? IV CD20 的平均持續時間似乎約為 5 年,而且還在成長。但他們確實損失了大約15%,這是我們對數據的理解,從第一次輸注到第二次輸注大約有15%,這是最大的下降。然後正如我所提到的,它從那裡開始甚至下降。因此,當您考慮退貨收入時,您需要考慮兩件事。希望這能回答問題。
Operator
Operator
Our next question is from Eric Joseph with JPMorgan.
我們的下一個問題來自摩根大通的埃里克約瑟夫。
Eric William Joseph - VP & Senior Analyst
Eric William Joseph - VP & Senior Analyst
I appreciate the guidance that you guys laid out for the fourth quarter and full year. Can you talk a little bit about your internal targets, I guess, to delivering on that expectation. I'm wondering sort of if the charge is to add new centers or expand share within existing centers or perhaps even lean a little bit more to this CD20 switch opportunity that is a bit surprising.
我感謝你們為第四季和全年制定的指導。我想,您能否談談您的內部目標,以實現這一期望。我想知道收費是否是為了增加新的中心或擴大現有中心的份額,或者甚至可能更傾向於這個有點令人驚訝的 CD20 轉換機會。
And maybe just one follow-up to that -- to your last comment, Adam, on repeat for week 24 infusion expectations, that 15% drop off, that's kind of a hard final number? Or is that -- or is it just sort of a time shifted, where you might sort of catch the patient but not quite exactly on a 24-week schedule?
也許只是一個後續行動 - Adam,您最後的評論,重複第 24 週的輸液預期,下降了 15%,這是一個硬性的最終數字嗎?或者是——或者只是時間上的轉移,你可能會抓住病人,但不完全按照 24 週的時間表?
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Yes. So let me -- I guess I can take -- You want me to go, Mike?
是的。那麼讓我——我想我可以——你想讓我走嗎,麥克?
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Yes, go ahead. Yes. Go ahead.
好,去吧。是的。前進。
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Okay. Yes. So to the first part of your question, yes, our strategy is to continue to increase enrollments and continue to find new business, adding new centers and new prescribers, obviously, is important. But at the same time, deepening experience seems to be something that's leading to more experience. I will say in this market that as physicians are getting used to the product or they want to try it, they want to see how it goes. They want to see how reimbursement goes and then they'll -- once they have that experience they -- and it goes well, then they will continue to add. So we're getting to the point here now where many, many physicians have had that experience now, they've gotten reimbursed and now they're willing to expand their base. So I think that's -- we'll continue to lean in there.
好的。是的。因此,對於你問題的第一部分,是的,我們的策略是繼續增加註冊人數並繼續尋找新業務,增加新中心和新處方者顯然很重要。但同時,加深經驗似乎會帶來更多經驗。我想說的是,在這個市場上,隨著醫生習慣該產品或他們想嘗試它,他們想看看它的效果如何。他們想看看報銷的情況如何,然後他們——一旦他們有了這種經驗——如果進展順利,他們就會繼續增加。所以我們現在已經到了這樣的地步,很多很多醫生現在都有過這種經歷,他們已經得到了報銷,現在他們願意擴大他們的基礎。所以我認為我們將繼續努力。
But I think there's plenty of opportunity here for us to expand usage into new centers and new prescribers. We've made great progress but there's plenty of opportunity for us to continue to grow both in academic centers as we've mentioned, is an area that has been slightly slower to adopt. It's increasing but it's been slightly slower. We think there's plenty of room in academic centers to increase. And then just in general, I mean, we're -- again, we're making good progress on penetration with our top prescribers but there's a lot of room for us to continue to grow.
但我認為我們有很多機會將其使用範圍擴大到新的中心和新的處方醫生。我們已經取得了巨大的進步,但正如我們所提到的,我們有很多機會繼續在學術中心發展,這是一個採用速度稍慢的領域。它正在增加,但速度略有放緩。我們認為學術中心還有很大的發展空間。總的來說,我的意思是,我們再次在頂級處方醫生的滲透率方面取得了良好進展,但我們還有很大的空間繼續增長。
And then the second part of your question was the 15%. Yes, I'm just -- what we're doing there is just -- we don't know obviously what our drop-off rate is going to look like. But we -- there is published data out there with the other IV CD20. We've looked at it and it's about a 15% that they're losing between dose 1 and -- the first dose and the week or the 6-month dose.
然後你問題的第二部分是15%。是的,我只是 - 我們正在做的只是 - 我們顯然不知道我們的下降率會是什麼樣子。但我們已經發布了其他 IV CD20 的數據。我們已經研究過,在第 1 劑和第 1 劑以及一周或 6 個月的劑量之間,他們的體重損失約為 15%。
Eric William Joseph - VP & Senior Analyst
Eric William Joseph - VP & Senior Analyst
Okay. In your hub, do you have visibility on week 24 prescriptions versus starting prescriptions? And is that sort of a metric that you anticipate providing or updating the [Street] on going forward?
好的。在您的中心,您是否了解第 24 週的處方與起始處方的情況?您期望在未來提供或更新 [Street] 的這種指標嗎?
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Yes, we don't get those. No, we don't necessarily get those. We get the first ones to come in. And then once they're in our hub then we are -- what we're doing is we're -- as they come up for their week 24 dose, we're reaching out to them. There's no requirement to come back into our hub at that point. But we're reaching out to them to see what we can do to help with the reverification of insurance benefits and so on and so forth. But note that we don't have access or visibility to the week 24 scripts.
是的,我們不明白這些。不,我們不一定能得到這些。我們讓第一批進來。然後,一旦他們到達我們的中心,我們 - 我們正在做的就是 - 當他們來接受第 24 週的劑量時,我們正在聯繫他們。屆時無需返回我們的中心。但我們正在聯繫他們,看看我們能做些什麼來幫助重新驗證保險福利等等。但請注意,我們無法存取或查看第 24 週的腳本。
Eric William Joseph - VP & Senior Analyst
Eric William Joseph - VP & Senior Analyst
All right. Great. Congrats on the quarter.
好的。偉大的。恭喜本季。
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Thanks, Eric.
謝謝,埃里克。
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Thank you, Eric.
謝謝你,埃里克。
Operator
Operator
Our next question is from Prakhar Agrawal with Cantor Fitzgerald.
我們的下一個問題來自普拉哈·阿格拉瓦爾和坎托·菲茨杰拉德。
Prakhar Agrawal - Senior Biotech Analyst
Prakhar Agrawal - Senior Biotech Analyst
Thank for taking my questions and congrats on the quarter. Maybe first question on the switches from Ocrevus, is this a trend that you think versus into next year? Or is there some sort of a bolus of Ocrevus patients wanting to switch initially maybe due to tolerability issues? Any color for -- would be appreciated?
感謝您回答我的問題並祝賀本季。也許關於 Ocrevus 的轉變的第一個問題是,您認為這是否是明年的趨勢?或者是否有一些 Ocrevus 患者最初由於耐受性問題而想要更換?任何顏色 - 將不勝感激?
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Yes, I'll take a crack at that, Adam, you could join in. I mean, based on my interactions with health care providers and even with our own folks, I would say that, that's something that would at least stay constant, if not grow over time. I think the more patients who go on Briumvi, the more patients will be interested in going on Briumvi. So if you're reasonably satisfied or somewhat unsatisfied but not horribly unsatisfied with your current CD20, you still may consider changing, you just want to see more utilization. So we've heard that from HCPs.
是的,我會嘗試一下,亞當,你可以加入。我的意思是,根據我與醫療保健提供者甚至與我們自己的人的互動,我會說,這至少會保持不變,如果不隨著時間的推移而增長。我認為使用 Biumvi 的患者越多,就會有越多的患者對使用 Biumvi 感興趣。因此,如果您對目前的 CD20 相當滿意或有些不滿意但不是非常不滿意,您仍然可以考慮更改,您只是想看到更多的利用率。我們從 HCP 那裡聽到了這一點。
I'll talk to some of the [Ocra] patients who are potentially candidates and they'll say, "Hey, I just want to wait a little longer to see more on market experience, hear more stories from you and your patients and how things are going." So I don't think it's -- it was about any sort of bolus. I do think it's about organic demand that will occur over time as more and more people see the potential benefits of switching over.
我會與一些潛在候選人的[Ocra] 患者交談,他們會說:「嘿,我只是想再等一會兒,看看更多的市場經驗,從您和您的患者那裡聽到更多故事,以及如何事情正在進展。”所以我不認為這與任何類型的推注有關。我確實認為這是隨著時間的推移,隨著越來越多的人看到轉換的潛在好處而出現的有機需求。
Adam, any further thoughts on that?
亞當,對此還有什麼進一步的想法嗎?
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
No, I think you covered it, Mike. Thanks.
不,我想你已經涵蓋了,麥克。謝謝。
Prakhar Agrawal - Senior Biotech Analyst
Prakhar Agrawal - Senior Biotech Analyst
Got it. And second question on expenses. So the expenses for 3Q were at the lower end of your OpEx guidance, excluding share comp and inventory build. So any one-offs for this quarter we should be aware of has been more of 4Q?
知道了。第二個問題是關於費用的。因此,第三季的費用處於營運支出指引的下限,不包括股份補償和庫存建設。那麼,我們應該注意的本季度的任何一次性事件都更多地發生在第四季度嗎?
And as a follow-up, any initial thoughts whether you expect a significant infection and expense growth trajectory for next year? Or is it more about steady growth?
作為後續行動,您是否預計明年會出現顯著的感染和費用成長軌跡?還是更注重穩定成長?
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Yes. I'll take the second part of that and Sean, maybe hit the expense question.
是的。我將討論第二部分,肖恩,也許會涉及費用問題。
In terms of any inflection in expenses, no, I think the short answer there is no. We do anticipate that the burn will creep up a bit. We've talked about that we've always had a plan to modestly expand our team. We're doing more what I refer to as their support or advertising initiatives, mostly online and social. So we are definitely creeping up on the burn but nothing too dramatic at all.
就費用的任何變化而言,不,我認為簡短的答案是沒有。我們確實預計燃燒會稍微加劇。我們已經討論過,我們一直有一個計劃來適度擴大我們的團隊。我們正在做更多我所說的支援或廣告活動,主要是線上和社交活動。因此,我們確實正在逐漸陷入困境,但並沒有太大的戲劇性。
And you've also talked about getting more aggressive on the R&D side. But again, nothing that will dramatically change or show any sort of major inflection in expenses. We've been saying that our operating burn is between $40 million and $50 million. But in fact, it's been slightly lower than that over the last 2 quarters in terms of true operating. So we have room to be within the $40 million to $50 million and should be pretty unnoticeable from a financial standpoint.
您也談到了在研發方面更加積極進取。但同樣,沒有任何事情會顯著改變或顯示支出的任何重大變化。我們一直說我們的營運消耗在 4000 萬至 5000 萬美元之間。但事實上,就真實營運而言,略低於過去兩季。因此,我們的空間在 4000 萬至 5000 萬美元之間,從財務角度來看應該相當不引人注目。
Sean, do you want to answer the question on the expense side?
Sean,你想回答一下費用方面的問題嗎?
Sean A. Power - CFO, Corporate Secretary & Treasurer
Sean A. Power - CFO, Corporate Secretary & Treasurer
Yes. Prakhar, would you mind just clarifying your question as early...
是的。 Prakhar,你介意儘早澄清你的問題嗎?
Prakhar Agrawal - Senior Biotech Analyst
Prakhar Agrawal - Senior Biotech Analyst
Right. So yes, for 3Q, it was at the lower end of your OpEx guidance, $40 million to $50 million for 3 -- for the quarter. So maybe any color on whether there were any one-offs or you -- and how should we think about the 4Q number?
正確的。所以,是的,對於第三季來說,它處於營運支出指引的下限,即第三季 4,000 萬至 5,000 萬美元。那麼,也許有關於是否有一次性或你的任何顏色——我們應該如何看待第四季度的數字?
Sean A. Power - CFO, Corporate Secretary & Treasurer
Sean A. Power - CFO, Corporate Secretary & Treasurer
Yes. No one-offs in the quarter. And I think Mike covered it pretty well as it relates to sort of the fourth quarter next year. So no one-offs in the quarter that really drove things being on the lower end of the range.
是的。本季沒有一次性事件。我認為麥克講得很好,因為它與明年第四季有關。因此,本季度沒有任何一次性事件真正推動事情處於範圍的低端。
Prakhar Agrawal - Senior Biotech Analyst
Prakhar Agrawal - Senior Biotech Analyst
Okay. Got it. And last question. There's some interesting data from the BTK drugs in MS. So how do you see those drugs impacting the CD20 class? And I know you had a BTK in the pipeline. Is there any plan to take that forward into MS?
好的。知道了。最後一個問題。 BTK 藥物治療多發性硬化症有一些有趣的數據。那麼您如何看待這些藥物對 CD20 類別的影響?我知道您正在醞釀一個 BTK。有沒有計劃將其推進到 MS 領域?
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Sure. So yes, the BTKs look interesting, I'd say, at this point from a far until we get the Phase III data, which I think is possible that we may see some first Phase III data before the end of this year. We won't really have a good sense of the exact profile. So I think I'll reserve too much judgment other than, I'll say, from a market standpoint, what we do here as folks are more excited about the potential for BTKs in primary progressive MS, where glial cell activation may be or inactivation through BTK could be a really nice mechanism for slowing the progression in the absence of active disease.
當然。所以,是的,我想說,從長遠來看,BTK 看起來很有趣,直到我們獲得第三階段數據,我認為我們有可能在今年年底之前看到一些第一個第三階段數據。我們無法真正了解確切的概況。因此,我認為我會保留太多的判斷,而不是從市場的角度來看,我們在這裡所做的事情,因為人們對BTK 在原發性進行性多發性硬化症中的潛力更加興奮,其中神經膠質細胞可能活化或失活透過 BTK 可能是在沒有活動性疾病的情況下減緩進展的非常好的機制。
RMS is primarily characterized by active disease, which is well served by the CD20 class and the convenience of once every 6 months doesn't seem to fit most people's high end of convenience factor. So unless something remarkable happens in the RMS patients, I think most people are looking at it for RMS patients as another oral option, which will compete with the current oral therapies but shouldn't really compete very much with the CD20s.
RMS 的主要特徵是活動性疾病,CD20 類藥物可以很好地滿足這一需求,每 6 個月一次的便利性似乎不符合大多數人的高端便利因素。因此,除非 RMS 患者發生顯著變化,否則我認為大多數人都會將其視為 RMS 患者的另一種口服選擇,它將與目前的口服療法競爭,但實際上不應與 CD20 競爭太多。
For primary progressive, again, on the other hand, that could be a potential competitor to CD20s if it performs at a high level. So it's all data dependent. We'll see how it looks. So certainly going to reserve judgment. We do have our own BTK. We've been hanging back. We have a lot of information in cancer patients about the profile of our drug. So we know what it looks like, we can move pretty quickly once we decide to pull the trigger. But we're going to sit back, let's see some data come out. Let's identify if there's an opportunity to fit in to the space, and we'll go from there. So we're all waiting on the data for the moment. Thanks, Prakhar.
另一方面,對於初級漸進式來說,如果它表現出色,它可能會成為 CD20 的潛在競爭對手。所以這一切都取決於數據。我們會看看它看起來如何。所以一定會保留判斷力。我們確實有自己的BTK。我們一直在猶豫。我們有大量關於癌症患者的藥物概況資訊。所以我們知道它是什麼樣子,一旦我們決定扣動扳機,我們就可以很快採取行動。但我們要坐下來,看看一些數據的公佈。讓我們確定是否有機會融入這個空間,然後我們就從那裡開始。所以我們現在都在等待數據。謝謝,普拉哈爾。
Prakhar Agrawal - Senior Biotech Analyst
Prakhar Agrawal - Senior Biotech Analyst
Thank you and congrats again.n
謝謝你,再次恭喜。n
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Thank you.
謝謝。
Operator
Operator
Our next question is from Matt Kaplan with Ladenburg Thalmann.
我們的下一個問題來自馬特·卡普蘭和拉登堡·塔爾曼。
Matthew Lee Kaplan - MD & Head of Healthcare Equity Research
Matthew Lee Kaplan - MD & Head of Healthcare Equity Research
Congrats on the strong quarter. Maybe -- can you give us a little bit more color? You said the momentum -- you're seeing the momentum continue past the end of the third quarter. Can you give us a little bit more color in terms of what you're seeing in October? And I guess maybe more broadly, do you expect to see any seasonality to the business at all?
恭喜季度表現強勁。也許——你能給我們多一點色彩嗎?你提到了這種勢頭——你看到這種勢頭持續到第三季末。您能為我們介紹一下您在 10 月看到的情況嗎?我想也許更廣泛地說,您預計業務會出現季節性嗎?
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Sure. Adam, do you want to go ahead and take that one?
當然。亞當,你想繼續接受那個嗎?
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Sure. Yes. Thanks, Matt. I appreciate the question. I think we've given guidance for the quarter. And at this point, I'm not going to get into any fourth quarter trends. I think the guidance will speak for itself there.
當然。是的。謝謝,馬特。我很欣賞這個問題。我認為我們已經給出了本季度的指導。在這一點上,我不打算討論任何第四季度的趨勢。我認為該指南將不言而喻。
In terms of seasonality, yes. I mean we did see some seasonality -- and we talked about this a little bit on the last call, we did see some seasonality over the summer months. In fact, when we looked at it, there is a sort of a dampening across the entire MS market in the summer months. We saw a slower July, followed by stronger months in August and September. But we do see -- at least we saw in early July and into July, a slowdown. And I think as people go on vacations, people go out of the office, it's natural, especially for infusion-based therapies and we are seeing that again with other IV CD20s as well.
從季節性來看,是的。我的意思是,我們確實看到了一些季節性——我們在上次電話會議上對此進行了一些討論,我們確實在夏季看到了一些季節性。事實上,當我們觀察時,整個微軟市場在夏季都出現了某種程度的抑制。我們看到 7 月成長放緩,隨後 8 月和 9 月成長強勁。但我們確實看到——至少我們在七月初和七月看到了經濟放緩。我認為當人們去度假時,人們會離開辦公室,這是很自然的,特別是對於基於輸注的療法,我們在其他 IV CD20 上也再次看到了這種情況。
So we did see that seasonality there. We're just launching, so we're continuing to look at the trends and trying to figure out what we might see from season to season. So hard to say what the future will bring. Of course, around holidays, when people don't want to get infused, that's a natural time where you'll see slowdowns. But other than that, I think we remains to be seen as we continue to move forward.
所以我們確實看到了季節性。我們剛剛推出,因此我們將繼續關注趨勢並試圖找出每個季節我們可能會看到的內容。很難說未來會帶來什麼。當然,在假期期間,當人們不想輸液時,自然會看到速度放緩。但除此之外,我認為我們繼續前進還有待觀察。
Matthew Lee Kaplan - MD & Head of Healthcare Equity Research
Matthew Lee Kaplan - MD & Head of Healthcare Equity Research
Adam, that's really helpful. And then, Mike, I think you commented on this in terms of in your prepared remarks. But can you talk a little bit more about the anticipated impact of the subcu, specifically subcu accretives into or on the anti-CD20 space in MS. And how important it is -- is it for you to have a subcu offering?
亞當,這真的很有幫助。然後,邁克,我認為您在準備好的發言中對此進行了評論。但您能否多談談 subcu 的預期影響,特別是 subcu 增生進入 MS 中的抗 CD20 空間或在 MS 中的抗 CD20 空間上的影響。提供 subcu 產品對您來說有多重要?
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Sure. Thanks, Matt. So yes, so if you take developers of subcu at their word in their last teleconference, they made it, I thought, pretty clear that they were going to use subcu to expand the market for the drug. So I don't think that it's a major competitive threat to IV CD20. I think their primary goal, again, I can only base it on what I heard and when I guess how I interpreted what they said. So I don't think it's going to have a major impact. I think they are going after that part of the market that has been reserved for subcu. One company has a monopoly in that area today. And I think the new subcu will try to compete for the extra convenience of a 1 on an every 6-month infusion. So I do think that it's going to have limited impact on the IV marketplace.
當然。謝謝,馬特。所以,是的,如果你相信 subcu 開發者在上次電話會議上所說的話,我認為他們非常明確地表明他們將使用 subcu 來擴大該藥物的市場。所以我不認為這對 IV CD20 構成重大競爭威脅。我認為他們的主要目標,我只能基於我所聽到的以及當我猜測我如何解釋他們所說的話時。所以我認為這不會產生重大影響。我認為他們正在爭奪為 subcu 保留的那部分市場。如今,有一家公司在該領域擁有壟斷地位。我認為新的 subcu 將嘗試競爭每 6 個月輸注 1 次的額外便利。所以我確實認為這對 IV 市場的影響有限。
In terms of the importance of us having a subcu. Again, it's not important from a primary goal for us, right? So our primary goal is to make Briumvi the #1 prescribed dynamic share IV CD20. That's what everyone in the company is working toward. So that's -- and I don't think a subcu Ocrevus is going to impact the overall IV market and our ability to potentially achieve that goal.
就我們擁有 subcu 的重要性而言。再說一次,從我們的主要目標來看,這並不重要,對吧?因此,我們的主要目標是使 Briumvi 成為排名第一的指定動態共享 IV CD20。這也是公司每個人都在努力的方向。所以,我認為 subcu Ocrevus 不會影響整個 IV 市場以及我們實現這一目標的能力。
Is it a potential area for us to expand and create a new market for Briumvi? Sure. And if we get to a point where we think we can develop a subcu that has a profile that is competitive with what's out there and available, we do think that, again, the subcu market is growing. We think they're building into general neurologists and other neurology practices that have not historically used a lot of IV CD20s.
這是我們為 Briumvi 拓展和創造新市場的潛在領域嗎?當然。如果我們認為我們可以開發出一種與現有產品具有競爭力的 subcu,那麼我們確實認為 subcu 市場正在成長。我們認為他們正在將其納入普通神經科醫生和其他神經病學實踐中,而這些實踐歷史上並未使用大量 IV CD20。
So again, we do think there's a market opportunity. We think there's something there. When you look at the 2 products that are available -- sorry, one product is available and one product that we expect will be available at some point, we think there is room for a more tolerable, more convenient product opportunity. So not sure that we'll get there but we think there's an opening. We'll just have to see if we can fit the gap.
再說一遍,我們確實認為有市場機會。我們認為那裡有東西。當您查看可用的 2 種產品時——抱歉,一種產品可用,另一種產品我們預計在某個時候將可用,我們認為還有空間提供更可容忍、更方便的產品機會。所以不確定我們能否到達那裡,但我們認為有一個空缺。我們只需要看看是否能夠彌補這個差距。
Matthew Lee Kaplan - MD & Head of Healthcare Equity Research
Matthew Lee Kaplan - MD & Head of Healthcare Equity Research
Congrats again on a good quarter.
再次恭喜季度表現良好。
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Yes, thank you.
是的,謝謝。
Operator
Operator
Our last question is from Mike DiFiore with Evercore ISI.
我們的最後一個問題來自 Evercore ISI 的 Mike DiFiore。
Michael Gennaro DiFiore - Equity Research Analyst
Michael Gennaro DiFiore - Equity Research Analyst
Congrats on the great quarter. Two for me, and I may have missed this, but regarding the J-Code, now that it's fully established at most intuitions, can we expect more of a gradual ramp? Or have we hit like a maximal establishment as far as the J-Code goes? And then I have a follow-up.
恭喜這個偉大的季度。對我來說有兩個,我可能錯過了這一點,但是關於 J 代碼,既然它在大多數直覺上已經完全建立,我們是否可以期待更多的逐步提升?或者說,就 J 程式碼而言,我們已經達到最大程度的建立了嗎?然後我有一個後續行動。
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Adam, do you want to go ahead with that one?
亞當,你想繼續那個嗎?
Adam Waldman - Chief Commercialization Officer
Adam Waldman - Chief Commercialization Officer
Yes. I mean I think the J-Code is a positive thing. I think we're going to continue to see a steady growth and continued adds. But in general, it's a good thing, provides confidence in reimbursement. And it's a positive milestone to reach and now it has been fully sort of loaded into payer systems and ASP has been established. So we're in good shape there, and we would expect to see continued steady growth.
是的。我的意思是,我認為 J 程式碼是一件正面的事情。我認為我們將繼續看到穩定成長和持續增加。但總的來說,這是一件好事,為報銷提供了信心。這是一個積極的里程碑,現在它已經完全加載到付款系統中,並且 ASP 已經建立。因此,我們的狀況良好,我們預計會看到持續穩定的成長。
Michael Gennaro DiFiore - Equity Research Analyst
Michael Gennaro DiFiore - Equity Research Analyst
Got it. Got it. And then just to go back to the whole BTK competitiveness question. I thought your comments were interesting on how based on your research so far, physicians, they seem like they view BTKs as just another oral option for relapsing remitting MS but if the first -- if Phase III data pans out and their efficacy is really good, either equal or on par to the anti-CD20 therapies. Why wouldn't KOLs use these oral BTKs options instead? I mean, any color would be helpful there.
知道了。知道了。然後回到整個 BTK 競爭力問題。我認為您的評論很有趣,根據您迄今為止的研究,醫生們似乎將BTK 視為復發緩解型多發性硬化症的另一種口服選擇,但如果第一個- 如果III 期數據成功並且其療效真的很好,與抗 CD20 療法相同或相當。為什麼 KOL 不使用這些口頭 BTK 選項?我的意思是,任何顏色都會有幫助。
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Yes. I mean, look, I think they will give them as options for patients. I think what we've heard and seen in the research is that patients do resonate toward an every 6-month treatment option. When I've talked to clinicians about our BTK in particular, and I've said, look, let's say It's just as good as the CD20 basis. So what, then they have to take a pill every day or twice a day? That's not as attractive as an every 6-month infusion. The other thing is compliance, right? Orals have historically poor compliance. So in terms of real-world experience at BTKs, even if they look phenomenal in clinical trials, compliance will be a problem. It's been for every oral drug.
是的。我的意思是,看,我認為他們會給他們作為病人的選擇。我認為我們在研究中聽到和看到的是,患者確實對每 6 個月一次的治療方案產生了共鳴。當我與臨床醫生特別談論我們的 BTK 時,我說,看,我們可以說它與 CD20 基礎一樣好。那又怎麼樣,那麼他們必須每天吃一粒藥或一天兩次嗎?這並不像每 6 個月注射一次那麼有吸引力。另一件事是合規性,對嗎?歷史上,口服藥物的依從性較差。因此,就 BTK 的實際經驗而言,即使它們在臨床試驗中看起來非常出色,但合規性仍將是一個問題。每種口服藥物都是如此。
There's some research that's kind of (inaudible) at UT Southwestern with Dr. Darin Okuda, who collects unused oral meds for MS, and I think it's collected. I'm going to make up a number and I could be wrong but anywhere from 25 million to 50 million of unused oral meds. So it is a major issue, compliance. So again, I just don't see it's going to go in the oral class, I assume. Again, I could be wrong but based on the conversations that I've had with folks, unless it's dramatically better than the CD20 even comparable activity to CD20 will just drop it into the oral bucket because for most of them, there's nothing more convenient and nothing more assured than a 6-month IV infusion.
UT 西南大學的 Darin Okuda 博士進行了一些(聽不清楚)研究,他收集了未使用的多發性硬化症口服藥物,我認為這些研究已經收集完畢。我要編一個數字,我可能是錯的,但有 2500 萬到 5000 萬未使用的口服藥物。所以這是一個主要問題,合規性。再說一次,我認為它不會出現在口語課上。再說一次,我可能是錯的,但根據我與人們的對話,除非它比CD20 顯著更好,否則即使與CD20 相當的活動也只會將其放入口頭桶中,因為對於大多數人來說,沒有什麼比CD20 更方便和更方便的了。沒有什麼比 6 個月的靜脈注射更放心的了。
So I believe that was the last question. Is that correct, operator?
所以我相信這是最後一個問題。這是正確的嗎,操作員?
Operator
Operator
Yes. There are no further questions at this time.
是的。目前沒有其他問題。
Michael S. Weiss - Chairman, CEO & President
Michael S. Weiss - Chairman, CEO & President
Excellent. Well, we've got 2 minutes to the market open. So I think we should bring this call to a conclusion.
出色的。距離開市還有 2 分鐘。所以我認為我們應該結束這通通話。
I just want to thank everyone again for joining us today. We feel really great about the launch and what we've done so far. Our team is really working super hard. They're sincere about really helping folks with MS. I would say the feedback we've gotten from the patients has been really heartwarming, and also really provides the fuel for everyone at TG to do what we do every day.
我想再次感謝大家今天加入我們。我們對此次發布以及迄今為止所做的事情感到非常高興。我們的團隊真的非常努力。他們真誠地希望真正幫助多發性硬化症患者。我想說,我們從患者那裡得到的回饋非常暖心,也確實為 TG 的每個人提供了每天所做工作的動力。
I think it's also important that we recognize the HCPs who put their trust in TG and Briumvi. We really do believe it's a best-in-class medicine and can offer real benefit to patients. As we close out the year, we'll continue to work hard to drive adoption. We need the revenue targets we have set and build value in TG for our shareholders and our employees.
我認為同樣重要的是,我們要認同那些信任 TG 和 Briumvi 的 HCP。我們確實相信它是一流的藥物,可以為患者帶來真正的好處。在這一年即將結束之際,我們將繼續努力推動採用。我們需要設定收入目標,並為我們的股東和員工創造 TG 的價值。
With that, I'd like to conclude the call. Have a great day, everybody. Thank you.
我想結束這通通話。祝大家有美好的一天。謝謝。
Operator
Operator
This concludes today's call. You may disconnect your lines at this time. Thank you for your participation.
今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。