TG Therapeutics Inc (TGTX) 2023 Q1 法說會逐字稿

Greetings, and welcome to the TG Therapeutics First Quarter 2023 Earnings Call. (Operator Instructions)

問候，歡迎來到 TG Therapeutics 2023 年第一季度收益電話會議。 （操作員說明）

As a reminder, this conference is being recorded. I would now like to turn the call over to Jenna Bosco. Thank you, you may begin.

提醒一下，這次會議正在錄製中。我現在想把電話轉給 Jenna Bosco。謝謝，可以開始了。

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

謝謝。歡迎大家，並感謝今天早上加入我們。我是 Jenna Bosco，今天和我一起討論 2023 年第一季度財務業績並提供業務更新的是我們的董事長兼首席執行官 Michael Weiss； Adam Waldman，我們的首席商業化先生；和我們的首席財務官 Sean Power。

Following our safe harbor statement, Mike will provide an overview of our recent corporate development. Adam will provide an update on our commercialization efforts and Sean will provide a brief 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，邁克將概述我們最近的公司發展。 Adam 將提供我們商業化工作的最新情況，Sean 將簡要概述我們的財務結果，然後將電話轉給接線員開始問答環節。

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 and expectations for our marketed and pipeline products.

在我們開始之前，我想提醒大家，我們將根據 1995 年《私人證券訴訟改革法案》做出前瞻性陳述。這些前瞻性陳述包括關於我們預期未來經營和財務業績的陳述，包括銷售業績、預計的監管里程碑以及對我們上市和管道產品的期望。

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.

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存在重大差異。可能影響 TG Therapeutics 運營的因素包括可以在我們的 SEC 文件中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 subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements.

此外，在此次電話會議上做出的任何前瞻性陳述僅代表我們截至今天的觀點，不應被視為代表我們在任何後續日期的觀點。我們特別聲明不承擔任何更新或修改任何前瞻性陳述的義務。

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.

此電話會議正在錄製，以便在 TG 的網站 www.tgtherapeutics.com 上進行音頻重播，未來 30 天將在該網站上播放。

With that, I would like to turn the call over to Mike Weiss, our CEO.

有了這個，我想把電話轉給我們的首席執行官 Mike Weiss。

Thanks, Jenna, and good morning, everyone, and thanks for joining us on today's call. 2023 is off to an excellent start for us at TG, with the U.S. approval and commercial launch of BRIUMVI. And we are excited to be able to offer patients the first and only anti-CD20 monoclonal antibody approved for relapsing forms of MS that can be administered in a one-hour fusion, twice a year following the starting dose. We believe that BRIUMVI's clinical profile has best-in-class potential in the treatment of multiple sclerosis and offers an exciting value proposition for all key constituents, including patients, providers and payers.

謝謝珍娜，大家早上好，感謝您參加今天的電話會議。隨著 BRIUMVI 在美國的批准和商業發布，2023 年對我們 TG 來說是一個良好的開端。我們很高興能夠為患者提供第一個也是唯一一個被批准用於復髮型 MS 的抗 CD20 單克隆抗體，這種抗體可以在一小時的融合中給藥，起始劑量後每年兩次。我們相信 BRIUMVI 的臨床資料在治療多發性硬化症方面具有一流的潛力，並為包括患者、提供者和付款人在內的所有關鍵組成部分提供令人興奮的價值主張。

Today, we are pleased to share the results of our first partial quarter of sales commencing on January 26, 2023. As such, we are essentially reporting on the first 2 months of BRIUMVI commercial availability. Our Chief Commercialization Officer, Adam Waldman, will join us shortly to provide some detailed metrics surrounding the first quarter results.

今天，我們很高興分享我們從 2023 年 1 月 26 日開始的第一個部分銷售季度的結果。因此，我們基本上報告了 BRIUMVI 商業可用性的前兩個月。我們的首席商業化官 Adam Waldman 將很快加入我們，提供有關第一季度業績的一些詳細指標。

Accordingly, I will keep my comments regarding the launch at a high level and touch on a few other topics that may be of interest to investors. With respect to the launch, we have said for some time that the profile of BRIUMVI has been well received by health care providers, and we are pleased to see such enthusiasm carrying through to the launch phase.

因此，我將保持對發布的高水平評論，並觸及投資者可能感興趣的其他幾個話題。關於上市，我們已經說過一段時間了，BRIUMVI 的形象受到了醫療保健提供者的好評，我們很高興看到這種熱情延續到上市階段。

Early adoption has come from both major academic centers and community practices. Geographically, all of our territories have seen HCPs prescribing BRIUMVI, and we have seen nice adoption within our target accounts. In terms of patients, we are also seeing a nice distribution of those that are new to MS treatment, new to CD20 treatment and also switches from other CD20, which we believe further underscores the attractiveness of the BRIUMVI profile.

早期採用來自主要學術中心和社區實踐。在地理上，我們所有的地區都看到 HCP 開出 BRIUMVI 的處方，並且我們在目標客戶中看到了很好的採用。在患者方面，我們也看到了 MS 治療新手、CD20 治療新手以及從其他 CD20 轉換而來的患者的良好分佈，我們認為這進一步強調了 BRIUMVI 概況的吸引力。

Overall, I believe our commercial teams and medical teams are doing a fantastic job introducing BRIUMVI to and educating health care providers on the attributes of BRIUMVI as well as building payer access. And I'm very pleased with the launch thus far.

總的來說，我相信我們的商業團隊和醫療團隊在將 BRIUMVI 介紹給醫療保健提供者並就 BRIUMVI 的屬性對醫療保健提供者進行教育以及建立付款人渠道方面做得非常出色。到目前為止，我對發布感到非常滿意。

With that, I'll move on, and I want to briefly talk about our European marketing authorization application and our ex U.S. launch plans. At the end of March, about a month ago, we announced that the committee from Medicinal Products for Human Use of the European Medicines Agency (inaudible) EMA, issued a positive opinion recommending the approval of BRIUMVI for the treatment of adult RMS patients with active disease defined by clinical or imaging features. With this opinion, we expect to hear a final decision from the EMA by early June.

有了這個，我將繼續，我想簡要談談我們的歐洲營銷授權申請和我們在美國的前發射計劃。大約一個月前的 3 月底，我們宣佈歐洲藥品管理局（聽不清）EMA 的人用藥品委員會發表了積極意見，建議批准 BRIUMVI 用於治療患有活性的成年 RMS 患者由臨床或影像學特徵定義的疾病。有了這個意見，我們希望在 6 月初之前聽到 EMA 的最終決定。

We continue to evaluate the best commercial pathway for us in Europe, either go to alone or partner, and we will seek to answer that question in the coming months to enable a European launch later this year, if approved. Whatever pathway we select, we see Europe as another opportunity to create additional shareholder value by making BRIUMVI available internationally.

我們將繼續評估我們在歐洲的最佳商業途徑，無論是單獨還是合作，我們將在未來幾個月內尋求回答該問題，以便在今年晚些時候在歐洲推出（如果獲得批准）。無論我們選擇何種途徑，我們都將歐洲視為通過在國際上銷售 BRIUMVI 來創造額外股東價值的另一個機會。

Finally, let me discuss TG's cash position. As reported, we ended the quarter with approximately $160 million in cash when you include that $20 million of additional capacity available to us under our Hercules facility. We continue to believe our current cash and associated incremental Hercules capacity, along with the modest assumptions of revenue, will be sufficient to take us into mid-2024. Of course, if revenues continue to exceed those in our cash model, our current cash should last even longer.

最後，讓我談談 TG 的現金狀況。據報導，當您將 2000 萬美元的額外產能包括在我們的 Hercules 設施下時，我們在本季度結束時獲得了大約 1.6 億美元的現金。我們仍然相信，我們目前的現金和相關的增量 Hercules 產能，以及適度的收入假設，將足以讓我們進入 2024 年年中。當然，如果收入繼續超過我們現金模式的收入，我們目前的現金應該會持續更長時間。

With our growing revenues and relatively stable burn, it is not clear how much, if any amount we would need to raise prior to cash flow breakeven. Accordingly, we are quite comfortable with our current cash position and with our many options for adding to the balance sheet in nondilutive or minimally dilutive ways.

隨著我們不斷增長的收入和相對穩定的消耗，目前尚不清楚在現金流盈虧平衡之前我們需要籌集多少資金（如果有的話）。因此，我們對目前的現金狀況以及我們以非攤薄或最低攤薄方式增加資產負債表的多種選擇感到非常滿意。

With that, let me turn the call over to Adam Waldman, our Chief Commercialization Officer, to share some additional color on our first quarter of launch. Adam?

有了這個，讓我把電話轉給我們的首席商務官 Adam Waldman，分享我們第一季度發布的一些額外顏色。亞當？

Yes. Thank you, Mike, and good morning, everybody. I'm excited to provide an update on our first quarter commercial performance. As Mike noted, BRIUMVI was approved at the end of 2022, and drug first became available at the end of January 2023. We are pleased with the initial adoption of BRIUMVI by the MS community, highlighted by net sales of $7.8 million in just the first 2 months of commercial launch, exceeding our internal expectations.

是的。謝謝邁克，大家早上好。我很高興提供我們第一季度商業業績的最新情況。正如 Mike 指出的那樣，BRIUMVI 於 2022 年底獲得批准，藥物於 2023 年 1 月底首次上市。我們對 MS 社區最初採用 BRIUMVI 感到高興，僅在第一個階段就實現了 780 萬美元的淨銷售額2 個月的商業發布，超出了我們的內部預期。

We believe our commercial teams executed exceptionally well in the first quarter, successfully engaging with nearly 100% of our initial targeted accounts, educating on BRIUMVI's product profile, proper infusion techniques and helping activate accounts to be ready to prescribe. We invested heavily to build on what we believe is a best-in-class patient support program, and the team is operating effectively to support our accounts and help patients to navigate the access and insurance process and the hurdles that are common in the first stages of the launch.

我們相信我們的商業團隊在第一季度的表現非常出色，成功地與我們最初目標客戶的近 100% 進行了接觸，對 BRIUMVI 的產品簡介、正確的輸液技術進行了教育，並幫助激活了準備開處方的客戶。我們投入巨資建立我們認為一流的患者支持計劃，該團隊正在有效運作以支持我們的客戶並幫助患者駕馭准入和保險流程以及第一階段常見的障礙發射。

The feedback from our customers on the responsiveness of our team has been positive. And I believe we've made a lot of progress in a short period of time establishing TG as a committed partner in the MS community. Based on the feedback from customers, we continue to believe that the BRIUMVI profile is attractive. Many of our health care providers have let us know that the one-hour infusion, combined with the lowest ARR seen in the Phase III trial are important and relevant differentiators in the competitive space.

客戶對我們團隊響應能力的反饋是積極的。我相信我們在短時間內取得了很大進展，將 TG 確立為 MS 社區的忠實合作夥伴。根據客戶的反饋，我們仍然相信 BRIUMVI 的配置文件具有吸引力。我們的許多醫療保健提供者都讓我們知道，一小時輸液以及 III 期試驗中出現的最低 ARR 是競爭領域中重要且相關的差異化因素。

We believe an important indicator of early success is measured by both breadth and depth of use. Accordingly, we were pleased to see that over 165 physicians or more than 125 centers in the U.S. prescribed BRIUMVI in the first partial quarter of our launch. Additionally, we believe prescriptions leading to registration in our patient support hub are a strong leading indicator of demand for BRIUMVI.

我們認為，早期成功的一個重要指標是通過使用的廣度和深度來衡量的。因此，我們很高興地看到美國超過 165 名醫生或超過 125 個中心在我們推出的第一部分處方中開出了 BRIUMVI。此外，我們認為導致在我們的患者支持中心註冊的處方是 BRIUMVI 需求的一個強有力的領先指標。

Accordingly, we were pleased to see that in our first partial quarter, more than 400 patients were prescribed BRIUMVI and enrolled in our hub, which we believe captures approximately 80% to 90% of total prescriptions in the quarter as not all prescriptions will lead to registration at the hub. It was also nice to see that there was significant acceleration of prescriptions in March over February and we continue to see the acceleration of prescriptions in April.

因此，我們很高興地看到，在我們的第一個部分季度，超過 400 名患者接受了 BRIUMVI 處方並註冊到我們的中心，我們認為這佔該季度總處方的大約 80% 至 90%，因為並非所有處方都會導致在中心註冊。很高興看到 3 月份的處方藥比 2 月份顯著加速，我們繼續看到 4 月份處方藥的加速增長。

Overall, we believe this represents strong demand for BRIUMVI in the early stages of launch which we believe is being driven by BRIUMVI's highly attractive therapeutic profile.

總體而言，我們認為這代表了在上市初期對 BRIUMVI 的強勁需求，我們認為這是受到 BRIUMVI 極具吸引力的治療方案的推動。

In terms of patient access, our pricing strategy was aimed at providing broad and fast access to BRIUMVI, and we believe that strategy is working as we continue to track ahead of our internal estimates on payer coverage. I'm pleased to share that we now have coverage policies in place for over 50% of covered lives across the U.S., which puts us well ahead of our midyear goal and in good position to be able to hit our corporate goal of achieving broad access to BRIUMVI with greater than 80% coverage by the end of 2023.

在患者訪問方面，我們的定價策略旨在提供廣泛和快速的 BRIUMVI 訪問，我們相信該策略正在發揮作用，因為我們繼續提前對付款人覆蓋率進行內部估計。我很高興地與大家分享，我們現在已經為全美 50% 以上的受保人制定了保險政策，這使我們遠遠領先於我們的年中目標，並且處於能夠實現我們實現廣泛訪問的公司目標的有利位置到 2023 年底，覆蓋率超過 80%。

We also recently announced that the U.S. Centers for Medicare and Medicaid Services, or CMS, has issued a permanent J-Code for BRIUMVI, which will become effective on July 1, 2023. This is great news and in addition to streamlining the reimbursement process, we believe this will facilitate additional patient access as there are many accounts that await to use BRIUMVI until the J-Code becomes effective on July 1.

我們最近還宣布，美國醫療保險和醫療補助服務中心 (CMS) 已為 BRIUMVI 發布永久性 J 代碼，該代碼將於 2023 年 7 月 1 日生效。這是個好消息，除了簡化報銷流程外，我們相信這將促進更多患者的訪問，因為在 J-Code 於 7 月 1 日生效之前，有許多賬戶等待使用 BRIUMVI。

Additionally, some of our largest academic institutions in the country are not yet prescribing BRIUMVI, as they have formulary processes that can take up to 6 months or more.

此外，我們國內一些最大的學術機構尚未開出 BRIUMVI 處方，因為它們的處方流程可能需要長達 6 個月或更長時間。

Accordingly, we see BRIUMVI accelerating in the second half of the year once the permanent J-Code is effective. And as these larger centers gain formulary approval, and we continue to expand our payer coverage. So to conclude, we feel as though we are off to a solid start on the BRIUMVI launch. We believe we have right team focused in the right places with the drug that we believe provides an attractive profile for physicians, patients and payers.

因此，一旦永久 J-Code 生效，我們預計 BRIUMVI 將在今年下半年加速發展。隨著這些較大的中心獲得處方批准，我們將繼續擴大我們的付款人覆蓋範圍。因此總而言之，我們感覺好像我們在 BRIUMVI 的發布上有了一個堅實的開端。我們相信我們有合適的團隊專注於正確的地方，我們相信這些藥物為醫生、患者和付款人提供了有吸引力的形象。

We are seeing strong early demand and willingness to try BRIUMVI from the top volume MS Centers and top-tier physicians across the country in both the academic and private practice settings. Payer coverage is ahead of schedule and we believe operational hurdles such as the J-Code and institutional formulary access will continue to improve throughout the year.

我們看到來自全國學術和私人診所的頂級 MS 中心和頂級醫生對嘗試 BRIUMVI 的強烈早期需求和意願。付款人的覆蓋範圍提前，我們相信 J-Code 和機構處方准入等運營障礙將在全年繼續改善。

With that, let me turn the call over to Sean Power, our CFO, to discuss the quarterly financial results.

有了這個，讓我把電話轉給我們的首席財務官肖恩鮑爾，討論季度財務業績。

Thanks, Adam, and thanks, everyone, for joining us. Earlier this morning, we reported our detailed first quarter 2023 financial results, which can be viewed on the Investors & Media section of our website.

謝謝亞當，也謝謝大家加入我們。今天早上早些時候，我們報告了 2023 年第一季度的詳細財務業績，可以在我們網站的投資者和媒體部分查看。

I'd like to begin today's call by again highlighting that we are pleased to report $7.8 million of BRIUMVI net product revenue in the first quarter. As for our broader financial results, our net loss for the first quarter of 2023, excluding noncash items, was approximately $32.6 million. down more than 50% from the first quarter of 2022, where we saw a net loss, excluding noncash items of approximately $67 million.

在今天的電話會議開始之際，我想再次強調，我們很高興地報告 BRIUMVI 第一季度的淨產品收入為 780 萬美元。至於我們更廣泛的財務業績，我們 2023 年第一季度的淨虧損（不包括非現金項目）約為 3260 萬美元。與 2022 年第一季度相比下降了 50% 以上，我們在第一季度看到了淨虧損，不包括約 6700 萬美元的非現金項目。

The year-over-year decrease is primarily the result of our disciplined and focused approach to spending and the streamlining of our R&D programs. Our GAAP net loss for the first quarter of 2023 was $39.4 million or $0.28 per share compared to a GAAP net loss of $69 million or $0.51 per share in the first quarter of 2022.

同比下降主要是由於我們嚴格和集中的支出方式以及精簡研發計劃的結果。我們 2023 年第一季度的 GAAP 淨虧損為 3940 萬美元或每股 0.28 美元，而 2022 年第一季度的 GAAP 淨虧損為 6900 萬美元或每股 0.51 美元。

And finally, on our cash position. We ended the first quarter with approximately $140 million in cash, cash equivalents and investment securities, which includes $25 million of capital drawn in the first quarter under our existing Hercules facility.

最後，關於我們的現金狀況。第一季度結束時，我們擁有大約 1.4 億美元的現金、現金等價物和投資證券，其中包括第一季度在我們現有的 Hercules 設施下提取的 2500 萬美元資金。

Additionally, we recently amended our Hercules facility and now have the ability to draw $20 million at our discretion into September of this year, leaving us with available capital of approximately $160 million. We believe our available capital when coupled with modest BRIUMVI revenue assumptions will take us out into mid-2024.

此外，我們最近修改了我們的 Hercules 設施，現在我們可以自行決定在今年 9 月提取 2000 萬美元，使我們的可用資本約為 1.6 億美元。我們相信，我們的可用資本加上適度的 BRIUMVI 收入假設將使我們進入 2024 年年中。

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

有了這個，我現在將把電話轉回給會議接線員開始問答。

(Operator Instructions)

（操作員說明）

Our first questions come from the line of Eric Joseph with JPMorgan.

我們的第一個問題來自摩根大通的 Eric Joseph。

Nice trends on the quarter. Maybe, Adam, can you elaborate a little bit more on sort of the mix you're seeing between sort of new to CD20 versus switches? Is it sort of more or less than you anticipated? And then I'm also curious about any, I guess, feedback you're getting on infusion times in the commercial setting beyond that initial dose, right, I guess, is -- are you seeing any -- at all any deviation, I guess, from the anticipated one-hour infusion time for folks getting their follow-up treatment -- follow-up in fusion?

本季度趨勢不錯。也許，亞當，你能詳細說明一下你在 CD20 和開關之間看到的混合類型嗎？它比你預期的多還是少？然後我也很好奇任何，我想，你在商業環境中獲得的輸液時間超過初始劑量的反饋，我想，是 - 你是否看到任何 - 任何偏差，我猜猜，從人們接受後續治療的預期一小時輸液時間——融合後續？

Adam, go ahead.

亞當，繼續。

Yes, yes, thanks, Eric, for the question. Yes, as Mike noted, we're seeing a mix of both naive and switch patients. And we're seeing -- with the switch patients, we're seeing a distribution of patients coming from a broad set of disease modifying therapies, including CD20s TYSABRI in the orals and injectables. So we're seeing a nice mix across all of that. It's a little too early to give more specifics here. We'll wait a little bit on that.

是的，是的，謝謝埃里克提出的問題。是的，正如 Mike 指出的那樣，我們看到既有天真的患者也有轉換患者。我們看到 - 對於轉換患者，我們看到來自廣泛的疾病改善療法的患者分佈，包括口服和注射劑中的 CD20s TYSABRI。所以我們看到了所有這些的完美結合。在這裡給出更多細節還為時過早。我們會稍等片刻。

As far as the infusion experience, all as expected, I think we're -- we don't -- we have good feedback on what we're seeing right now is as expected. We're not seeing any unexpected adverse events and the feedback on the infusion so far has been largely positive.

就輸液體驗而言，一切都符合預期，我認為我們——我們沒有——我們對我們現在看到的情況有很好的反饋，正如預期的那樣。我們沒有看到任何意外的不良事件，到目前為止對輸液的反饋基本上是積極的。

I'll just add -- I'll just end on top of that. I've obviously been out in the field myself and everything I've heard is that the infusion time is on target.

我只是補充 - 我將在此結束。很明顯，我自己也去過現場，我所聽到的一切都是輸液時間達到了目標。

Okay. Great. And just -- and Mike, can you unpack print a little bit. Is there an inventory component here or a channel component we should be thinking about? And to the extent there is, I guess, how should we be thinking about that sort of building or not going forward?

好的。偉大的。只是 - 邁克，你能拆開印刷品嗎？這裡是否有我們應該考慮的庫存組件或渠道組件？在某種程度上，我想，我們應該如何考慮這種建築或不繼續進行？

Yes, Adam, go ahead. Adam, can you reach in?

是的，亞當，繼續。亞當，你能進去嗎？

Yes, I'm here, sorry. We did not see a lot of stocking at the distributors in the first quarter, Eric. Inventory is what you would expect in a launch and the vast majority of sales was demand-driven.

是的，我在這裡，對不起。埃里克，我們在第一季度沒有看到經銷商有大量庫存。庫存是您在發佈時所期望的，絕大多數銷售都是需求驅動的。

Our next questions come from the line of Ed White with H.C. Wainwright.

我們的下一個問題來自 Ed White with H.C.溫賴特。

Congratulations on the sales number. Perhaps you can give us a few comments on percentage of free drug. What percentage of patients you're seeing take advantage of the patient access programs?

恭喜銷量上號。也許你可以給我們一些關於免費藥物百分比的評論。您看到的患者中有多少百分比利用了患者訪問計劃？

Sure. Adam?

當然。亞當？

Yes. We saw -- thanks for the question. We saw about 10% to 15% of free goods on top of the sales that we saw. So 10% to 15%. The majority of that was through our Quick Start program. We do expect that those patients will convert to commercial drug in the second half of the year.

是的。我們看到了——謝謝你的提問。除了我們看到的銷售額之外，我們還看到了大約 10% 到 15% 的免費商品。所以 10% 到 15%。其中大部分是通過我們的快速啟動程序實現的。我們確實預計這些患者將在下半年轉為使用商業藥物。

Great. And just a question on expenses. R&D was dramatically lower in the first quarter versus the fourth quarter of last year and the SG&A was much higher as you're proceeding with the launch. I'm just wondering if there's any guidance you can give us on what those expenses are going to look like quarter-over-quarter throughout the year and how to ramp?

偉大的。只是關於費用的問題。與去年第四季度相比，第一季度的研發費用大幅降低，而隨著產品的推出，SG&A 的費用要高得多。我只是想知道您是否可以就全年這些支出的季度環比情況以及如何增加提供任何指導？

Sure. Sean, do you want to tackle that one?

當然。肖恩，你想解決這個問題嗎？

Yes. Sure. One thing to note on the R&D front is prior to approval the manufacturing of BRIUMVI could have run through R&D. That will now run through inventory. So that is, of course, part of the decrease there as well as sort of the streamlining of our broader R&D programs. So I would say I'd expect R&D to remain pretty consistent with what you saw in the first quarter over the remainder of '23. And I would express the same sentiment for SG&A as well.

是的。當然。在研發方面需要注意的一件事是，在獲得批准之前，BRIUMVI 的製造可以通過研發進行。現在將通過庫存運行。因此，這當然是減少的一部分，也是我們更廣泛的研發計劃的精簡。所以我想說，我希望研發在 23 年剩餘時間裡與你在第一季度看到的情況保持一致。我也會對 SG&A 表達同樣的看法。

Our next questions come from the line of Prakhar Agrawal with Cantor Fitzgerald.

我們的下一個問題來自 Prakhar Agrawal 與 Cantor Fitzgerald 的對話。

Congrats on the great quarter. So firstly, maybe a clarification. Out of the greater than 400 prescriptions, how many patients were infused in the first quarter and had a follow-up.

祝賀這個偉大的季度。所以首先，也許需要澄清一下。在這400多張處方中，有多少患者在第一季度輸液並進行了隨訪。

Yes, sure. I'll take a crack and then Adam may want to talk. So we don't know exactly how many patients get infused. We don't have access to that information. So we only actually know when the script is written and only the scripts that go through the hub, right? So we don't have perfect information on total scripts. And we don't have very much information other than anecdotal from the field on what actually gets infused and when it gets infused. So -- and I think the 400 plus up to maybe another 50 to 100 perhaps, we don't know exactly -- prescriptions were written during the quarter. Most or some of those will be fulfilled in the quarter, we don't know. Some will be fulfilled in the next quarter, perhaps, but -- and perhaps someone won't get filled at all, to be honest.

是的，當然。我先吃點東西，然後 Adam 可能想談談。所以我們不知道究竟有多少患者接受了輸液。我們無權訪問該信息。所以我們實際上只知道腳本何時編寫，並且只知道通過集線器的腳本，對嗎？所以我們沒有關於所有腳本的完美信息。除了來自該領域的關於實際注入什麼以及何時注入的軼事，我們沒有太多信息。所以——我認為 400 多到 50 到 100 可能，我們不確切地知道——處方是在本季度寫的。我們不知道，其中大部分或部分將在本季度完成。有些人可能會在下個季度完成，但是 - 老實說，也許有些人根本不會被填滿。

So I think the demand, as Adam mentioned in his prepared remarks, was quite strong, and we'll see those conversions into final infusions over time. And we'll get some of them. We will, I think, over time, be able to capture the infusions that occur for people who went to the hub, but that's -- and that's basically just our reps going to the sites and actually collecting the information. And so at this point, it's way too early for us to have a good number on that. Adam, any thoughts there?

所以我認為，正如亞當在準備好的發言中提到的那樣，需求非常強勁，隨著時間的推移，我們將看到這些轉化為最終輸液。我們會得到其中的一些。我認為，隨著時間的推移，我們將能夠捕捉到前往中心的人們的輸液情況，但這基本上只是我們的代表前往現場並實際收集信息。所以在這一點上，我們現在就得出一個好的數字還為時過早。亞當，有什麼想法嗎？

No, you're right. I mean we just don't have the accurate information at this point.

不，你是對的。我的意思是我們目前還沒有準確的信息。

Got it. And -- my second question, consensus for the full year is around $65 million to $70 million, which, based on my math would imply 2,000 to 2,500 patients on BRIUMVI depending on how gross to net discounts pan out. So I know you guys are not giving guidance right now, but if you can comment on your comfort level on where the Street is at based on the trends you are seeing right now?

知道了。而且——我的第二個問題，全年的共識是大約 6500 萬到 7000 萬美元，根據我的數學計算，這意味著 BRIUMVI 有 2000 到 2500 名患者，具體取決於總折扣到淨折扣的結果。所以我知道你們現在沒有給出指導，但是你是否可以根據你現在看到的趨勢評論你對華爾街所處位置的舒適程度？

Adam, would you like to say to that?

亞當，你想說嗎？

Yes. I think it's still too early. We're still early in this launch. I think we'd like another quarter of time to give you guidance on that.

是的。我認為現在還為時過早。我們還處於此次發布的早期階段。我想我們還需要四分之一的時間來為您提供這方面的指導。

I guess if I can have one more question. How do you expect the gross to net discounts to track over the course of the year? And what was the gross to net for this quarter?

我想我是否可以再問一個問題。您預計全年的毛折扣與淨折扣的關係如何？本季度的毛淨收入是多少？

Yes. Yes -- yes, gross to net in the quarter was 77%. We do expect that to fluctuate quarter-to-quarter. Source of business will change. There will be some fluctuations. So in the first quarter, it was 77%. We're not going to give any guidance yet at the full year. As we get more information, we'll continue to update you.

是的。是的——是的，本季度的毛淨比為 77%。我們確實預計這會按季度波動。業務來源將發生變化。會有一些波動。所以在第一季度，它是 77%。我們不會在全年給出任何指導。隨著我們獲得更多信息，我們將繼續為您更新。

Our next questions come from the line of Matt Kaplan with Ladenburg Thalmann.

我們的下一個問題來自 Matt Kaplan 和 Ladenburg Thalmann。

Congrats on the quarter. I guess just starting off a little bit. Can you elaborate a little bit more on your ex U.S. plans. And how you're thinking about partnering versus going alone?

祝賀這個季度。我想剛開始一點點。你能詳細說明一下你之前在美國的計劃嗎？您如何考慮合作與單獨行動？

Yes. So I mean, again, we're just continuing to do the analysis of what the ex U.S. market looks like. I mean we've kind of narrowed it down that if we're going alone, we'd probably focus primarily in Germany, where we think the vast majority of the ex U.S. market resides. There's obviously more global opportunity than that. But again, if it's going to be a go-it-alone strategy, we'll probably be more focused and we start there. And obviously, there's other European countries we could add on pretty easily.

是的。所以我的意思是，我們只是繼續分析前美國市場的情況。我的意思是，我們已經縮小了範圍，如果我們單獨行動，我們可能會主要關注德國，我們認為除美國以外的絕大多數市場都位於德國。顯然還有比這更多的全球機會。但同樣，如果這將是一個單打獨鬥的戰略，我們可能會更加專注並從那裡開始。顯然，我們可以很容易地加入其他歐洲國家。

On the partnership side, look, we continue to evaluate potential partners. Obviously, one of the biggest concerns we have is doing a partnership when we recognize the value we can achieve for a partnership is going to be less than we probably get for the ex U.S. rights in a strategic relationship. So it's important to us to manage that, make sure we have flexibility with the ex U.S. territory. So I think, again, we're looking into and we're evaluating the opportunities available to us, both alone and with partners.

在夥伴關係方面，看，我們繼續評估潛在的合作夥伴。顯然，我們最大的擔憂之一是建立夥伴關係，因為我們認識到我們可以為夥伴關係實現的價值將低於我們在戰略關係中可能獲得的前美國權利。因此，管理這一點對我們來說很重要，確保我們在前美國領土上具有靈活性。因此，我再次認為，我們正在研究並評估我們可以單獨和與合作夥伴一起獲得的機會。

And we're getting close. Hopefully, we're going to make that decision in the coming months. And again, like we said in the prepared remarks, hopefully, to be prepared to launch later this year.

我們越來越接近了。希望我們將在未來幾個月內做出該決定。再次，就像我們在準備好的發言中所說的那樣，希望能為今年晚些時候推出做好準備。

Okay. And then in terms of -- maybe a question for Adam, how your messaging and specifically, I guess the infusion times and the current label of the product is initially resonating with prescribers out there in the field? What type of feedback are you getting?

好的。然後就-也許是亞當的問題，你的消息傳遞方式，具體來說，我猜輸液時間和產品的當前標籤最初是如何引起現場處方的共鳴的？你得到什麼類型的反饋？

Matt. I think we're focused on the feedback that we've gotten from our customers is that it's really the efficacy combined with the efficiency. So the efficacy of the drug is important to all physicians that are taking care of patients. But what BRIUMVI adds is the efficiency of a faster infusion and overall infusion experience. So that's what's resonating with customers. And of course, the overall experience that they have with the infusion itself will certainly be tracking and watching as we noted before, and we think the consistency of being able to -- in our trial, if you remember, 95% of the infusions were delivered in without interruption. And that's an important thing for us to continue to watch in the real world and make sure that, that's consistent with the trial results.

馬特。我認為我們關注的是我們從客戶那裡得到的反饋，即它確實是功效與效率的結合。因此，藥物的療效對於所有照顧患者的醫生來說都很重要。但 BRIUMVI 增加的是更快輸液的效率和整體輸液體驗。這就是與客戶產生共鳴的原因。當然，他們對輸液本身的整體體驗肯定會像我們之前提到的那樣進行跟踪和觀察，我們認為能夠的一致性——如果你還記得的話，在我們的試驗中，95% 的輸液是不間斷地交付。這對我們來說很重要，需要繼續在現實世界中觀察並確保與試驗結果一致。

But if that does play out, that will also be a very important thing to physicians and infusion centers going forward.

但如果真的成功了，那對於未來的醫生和輸液中心來說也將是一件非常重要的事情。

Okay. That's helpful. And then last question in terms of IMS and Symphony databases. How should we think about the capture rate there kind of now and going forward and the usefulness of those sources?

好的。這很有幫助。然後是關於 IMS 和 Symphony 數據庫的最後一個問題。我們應該如何考慮現在和未來的捕獲率以及這些資源的用途？

Yes. I'll jump in for a quick commentary, and then Adam provides some more. I think in the early days, people should use those resources with severe caution. I don't think they track very well early on. I assume at some point, later on in the launch, probably closer to third, fourth quarter into next year, there'll be an established pattern, and we can get a sense of where -- what they're actually capturing versus what's actually happening. But I think personally, I would use those numbers with extreme caution.

是的。我會插話進行快速評論，然後 Adam 會提供更多內容。我認為在早期，人們應該非常謹慎地使用這些資源。我不認為他們早期跟踪得很好。我假設在某個時候，在發布的後期，可能接近明年的第三、第四季度，將會有一個既定的模式，我們可以了解他們實際捕獲的內容與實際捕獲的內容發生。但我個人認為，我會極其謹慎地使用這些數字。

Adam, any thoughts?

亞當，有什麼想法嗎？

Yes. I mean the only thing I would add is that we do have a direct distribution program that is not captured in the Symphony data, which makes it even more difficult to interpret those numbers. So I agree with Mike's comments.

是的。我的意思是，我唯一要補充的是，我們確實有一個未在 Symphony 數據中捕獲的直接分發程序，這使得解釋這些數字更加困難。所以我同意邁克的意見。

Our next questions come from the line of Mayank Mamtani with B. Riley.

我們的下一個問題來自 Mayank Mamtani 與 B. Riley 的對話。

Congrats also on the progress. So maybe just at a higher level, if you could kind of talk about the distribution network and maybe specifically the prescription trends that you may have visibility from the institutional buyers versus the direct purchase by clinics? And what sort of revenue recognition mix exist, given patient support programs may apply more to one channel versus the other end? And if you could comment on how that trend may evolve over the course of the year? Then I have a follow-up.

也祝賀你的進步。所以也許只是在更高的層次上，如果你能談談分銷網絡，也許特別是你可能從機構買家那裡看到的處方趨勢與診所直接購買的情況？鑑於患者支持計劃可能更多地應用於一個渠道而不是另一端，存在什麼樣的收入確認組合？如果你能評論一下這一趨勢在這一年中可能會如何演變？然後我有一個後續行動。

Go ahead, Adam.

去吧，亞當。

Yes, Mike, if I understood the question, we have -- I mean the way we set this up was to make sure that we're meeting customers where they want to be. We have a -- we are selling at all the major distributors for BRIUMVI. We also have our own direct distribution program. I'm not going to get into the percentages at each at this point, but that's the general way out of our distribution program.

是的，邁克，如果我理解這個問題，我們有 - 我的意思是我們設置它的方式是確保我們在他們想要的地方會見客戶。我們有——我們在 BRIUMVI 的所有主要經銷商處銷售。我們也有自己的直接分銷計劃。在這一點上，我不打算討論每一個的百分比，但這是我們分配計劃的一般方式。

Okay. And how you expect to see this evolve through the course of the year? Are there -- with academic centers coming on board and also the impact of J-Code and -- are you able to comment on how this mix may evolve through 2023 and beyond?

好的。您希望在這一年中看到這種情況如何演變？是否有 - 隨著學術中心的加入以及 J-Code 的影響 - 你能否評論這種組合在 2023 年及以後可能如何演變？

Yes. I think we've been consistent in saying that we do believe this launch will gradually accelerate as some of these operational challenges alleviate throughout the year. The J-Code is one very good news that we got the J-Code that will become effective on July 1. And as I mentioned in the prepared remarks, we'll continue to see formulary wins at major academic centers. So that will continue to increase our academic prescribing. So we do expect an acceleration in the second half of the year, as these operational hurdles continue to alleviate. And yes, that's -- I hope that answers your question.

是的。我認為我們一直在說，我們確實相信隨著全年這些運營挑戰中的一些挑戰的緩解，此次發布將逐漸加速。 J-Code 是一個非常好的消息，我們獲得了將於 7 月 1 日生效的 J-Code。正如我在準備好的評論中提到的，我們將繼續在主要學術中心看到處方集的勝利。因此，這將繼續增加我們的學術處方。因此，隨著這些運營障礙繼續緩解，我們確實預計今年下半年會加速增長。是的，那是——我希望這能回答你的問題。

Yes.

是的。

I could add -- if you want, I'll add on to that a little bit. I mean I think -- as Adam mentioned in his remarks, I mean, we've had a really nice distribution between community and academic, probably slightly skewed towards the community side, which, again, getting back to the cautionary notes on IMS or Symphony, the community is more likely to use the direct channel, which does not get captured. So that's one portion of the distribution. I think to Adam's point, as we knock down these hurdles, each side will open up a little bit more, right? So community side, the J-code is probably more of a problem than formulary access because they're smaller and they do their own formula and they don't have a big bureaucracy.

我可以補充——如果你願意，我會補充一點。我的意思是我認為——正如 Adam 在他的評論中提到的，我的意思是，我們在社區和學術界之間的分佈非常好，可能略微偏向社區方面，這再次回到關於 IMS 或Symphony，社區更有可能使用不會被捕獲的直接渠道。這就是分發的一部分。我認為亞當的觀點是，當我們克服這些障礙時，每一方都會開放一點，對嗎？因此，在社區方面，J 代碼可能比公式訪問更成問題，因為它們規模較小，他們有自己的公式，而且沒有大的官僚作風。

On the academic side, it's going to be the formulary, which will open up more access to a lot more academic centers. My guess is -- if I have a guess, my guess is the blend later in the year, probably goes back towards the academic side. But again, it's hard to really know at this point. We're seeing great demand from both sides. And you know that there's a lot of pent-up potential from both sides. So I'm looking forward to seeing how that all plays out myself actually.

在學術方面，它將成為處方集，這將打開更多進入更多學術中心的途徑。我的猜測是——如果我有猜測的話，我的猜測是今年晚些時候的融合，可能會回到學術方面。但同樣，在這一點上很難真正知道。我們看到雙方都有很大的需求。你知道雙方都有很多被壓抑的潛力。所以我很期待看到這一切實際上是如何發揮作用的。

Got it. And then on you just quickly, I know it's a little early. You're not in the market yet, but we know that anti-CD20 penetration may not have been that prolific that we've seen in the U.S. So I was just curious to hear your thoughts on whether -- what your understanding is the reason for that? And if at all, you expect that you could participate in that increased penetration of anti-CD20 drug class in EU. If there's any incremental color there?

知道了。然後你很快，我知道現在有點早。你還沒有進入市場，但我們知道抗 CD20 的滲透可能沒有我們在美國看到的那麼多所以我只是想听聽你的想法——你的理解是什麼原因為了那個原因？如果有的話，您希望您可以參與抗 CD20 藥物類別在歐盟的滲透率增加。如果那裡有任何增量顏色？

And then lastly, in your cash burn estimate, are you incorporating any EU revenues? And also on the cost side, doing additional clinical trials, for example, the subcu study is something, Mike, you talked about in the prior call, if that -- if there's been any progress on making a decision on that or if you're just waiting for the low shape through readout in that quarter?

最後，在您的現金消耗估算中，您是否將任何歐盟收入納入其中？還有在成本方面，進行額外的臨床試驗，例如，subcu 研究，Mike，你在之前的電話中談到過，如果 - 如果在做出決定方面有任何進展，或者如果你'您只是在等待那個季度的低位讀數嗎？

Yes. So on the EU revenue front, I don't think we have anything incremental other than we do see nice growth ex U.S. for CD20. And I think as you noted, there's a lot of potential to grow the CD20 class. And again, we think with BRIUMVI's best-in-class profile potential, we think that it's a nice offering. We've had really good discussions with some KOLs in Germany.

是的。因此，在歐盟收入方面，除了我們確實看到 CD20 在美國以外的良好增長之外，我認為我們沒有任何增量。我認為正如你所指出的，CD20 類有很大的發展潛力。再一次，我們認為 BRIUMVI 具有一流的潛力，我們認為這是一個不錯的產品。我們與德國的一些 KOL 進行了很好的討論。

So we do feel very good about the potential opportunity, and we agree with you that there's plenty of room for growth of CD20s outside the U.S. So I don't have much more for you on that, but I do take your point. In terms of cost of goods, the clinical trials. So the -- in terms of clinical trial expenses, yes, I don't see a major increase during the course of this year. In terms of the subcu development, right now, it's a CMC project.

因此，我們確實對潛在的機會感覺非常好，我們同意你的看法，即美國以外的 CD20 有很大的增長空間。所以我沒有更多關於這方面的信息，但我同意你的觀點。在商品成本方面，臨床試驗。所以——就臨床試驗費用而言，是的，我認為今年期間不會有大幅增加。就subcu開發而言，目前，它是一個CMC項目。

So we need to understand exactly what the properties of -- physical, chemical properties of that subcu will look like. So that's not going to really hit probably from a clinical trial perspective significantly this year. We have some other clinical trials that we're working on that are not going to be costing that much, and we continue to lower the burn from the legacy trial.

因此，我們需要準確了解子單元的物理、化學性質。因此，今年從臨床試驗的角度來看，這可能不會真正受到影響。我們正在進行其他一些臨床試驗，這些試驗不會花費那麼多，而且我們會繼續降低遺留試驗的成本。

So there's still room to save money on clinical trials that we've had to carry on and carry forward some for ethical reasons, but we're winding those things down at this point. So I think as those come down, some of the new clinical stuff that we're doing will come in. But as Sean mentioned, I think our R&D line should be pretty stable throughout the year.

因此，出於道德原因，我們不得不進行和推進一些臨床試驗，但仍有節省資金的空間，但我們目前正在結束這些事情。所以我認為隨著這些下降，我們正在做的一些新的臨床工作將會出現。但正如肖恩提到的，我認為我們的研發線全年應該非常穩定。

Our next question is come from the line of Josh Schimmer with Evercore.

我們的下一個問題來自 Evercore 的 Josh Schimmer。

Apologies if I missed this, but the cost of goods line is relatively low considering that you do a royalty. Was there a capitalized cost of goods that you're working through? And if so, how much? And what do you expect the normalized cost of goods as a percentage of sales to be going forward?

如果我錯過了這一點，我深表歉意，但考慮到您收取版稅，商品線的成本相對較低。您是否正在處理商品的資本化成本？如果是這樣，多少錢？您預計商品的標準化成本佔銷售額的百分比是多少？

Yes. So that's a great point. I'm going to let Sean handle that. But yes, we did capitalize from the inventory that we built up prior to launch, but go ahead, Sean -- add some more detail there.

是的。所以這是一個很好的觀點。我要讓肖恩處理這件事。但是，是的，我們確實利用了我們在發布之前建立的庫存，但是繼續，肖恩——在那裡添加更多細節。

Yes, exactly right, Mike. Any goods that we produced prior to approval were expensed through R&D. So the early part of the launch will work through that stack of goods, if you will. I don't want to call it inventory, but it's not done. In the first quarter, we did capitalize some inventory on the balance sheet that amounted to about $25 million. And that will likely be the sole campaign in 2023, and then we'll see some again in '24.

是的，完全正確，邁克。我們在批准之前生產的任何商品都通過研發支出。因此，如果您願意的話，發布的早期部分將處理這些貨物。我不想稱之為庫存，但還沒有完成。第一季度，我們確實將資產負債表上的一些存貨資本化，總計約 2500 萬美元。這可能是 2023 年的唯一活動，然後我們將在 24 年再次看到一些活動。

Thank you. That is all the time we have for questions today. I would now like to turn the call back over to Michael Weiss for any closing comments.

謝謝。這就是我們今天提問的全部時間。我現在想將電話轉回給 Michael Weiss 以徵求任何結束意見。

Great. Thank you. So again, as I believe you've heard today, we are quite pleased with the launch to date. We remain confident that BRIUMVI offers patients a differentiated CD20 option in a growing class. We believe the BRIUMVI profile, along with the convenient one-hour infusion administered twice a year at the lowest price of any branded MS treatment together affirm our belief that BRIUMVI has a best-in-class potential.

偉大的。謝謝。因此，正如我相信您今天已經聽到的那樣，我們對迄今為止的發布感到非常滿意。我們仍然相信 BRIUMVI 為不斷增長的患者提供差異化的 CD20 選擇。我們相信 BRIUMVI 簡介以及每年兩次以任何品牌 MS 治療的最低價格進行的方便的一小時輸液一起證實了我們的信念 BRIUMVI 具有一流的潛力。

I want to thank everyone at TG for a fabulous effort. In addition to the commercial medical teams that are on the front lines, our clinical, our regulatory, safety, manufacturing, supply chain quality, legal and compliance and finance teams, have all performed at the highest levels to make this early launch possible. Everyone at TG remains committed to serving the MS Community and everything we do, we do with a focus on improving the lives of those living with MS.

我要感謝 TG 的每一個人，感謝他們付出的巨大努力。除了處於前線的商業醫療團隊外，我們的臨床、監管、安全、製造、供應鏈質量、法律和合規以及財務團隊都以最高水平開展工作，使這一早期發布成為可能。 TG 的每個人都致力於為 MS 社區和我們所做的一切服務，我們所做的一切都是為了改善 MS 患者的生活。

Thank you again for joining us today, and have a great day.

再次感謝您今天加入我們，祝您度過愉快的一天。

Thank you. That does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.

謝謝。今天的電話會議到此結束。感謝您的參與。此時您可以斷開線路。享受你剩下的一天。