TG Therapeutics Inc (TGTX) 2023 Q2 法說會逐字稿

Greetings, and welcome to the TG Therapeutics Second Quarter 2023 Financial Results and Business Update Call. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco. Thank you, Ms. Bosco, you may begin.

您好，歡迎參加 TG Therapeutics 2023 年第二季度財務業績和業務更新電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。現在我很高興向大家介紹你們的主持人珍娜·博斯科 (Jenna Bosco)。謝謝博斯科女士，您可以開始了。

Thank you. Welcome, everyone, and thanks for joining us this morning. I am Jenna Bosco and with me today to discuss this morning's news of our ex-U.S. commercialization partner as well as the results for the second quarter of 2023 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。我是珍娜·博斯科，今天和我一起討論今天早上我們前美國的新聞。商業化合作夥伴以及 2023 年第二季度的業績由我們的董事長兼首席執行官 Michael Weiss 負責； Adam Waldman，我們的首席商業化官；以及我們的首席財務官 Sean Power。

Following our safe harbor statement, Mike will provide an overview of today's news as well as our corporate development. Adam will give 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，邁克將概述今天的新聞以及我們的公司發展。 Adam 將介紹我們商業化工作的最新情況，Sean 將簡要概述我們的財務業績，然後將電話轉交給運營商以開始問答環節。

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 milestones and expectations for our marketed and pipeline 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運營和財務業績的聲明，包括銷售業績、預計里程碑以及對我們已上市和管道產品的期望。 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 subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. Today's 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. Now I would like to turn the call over to Mike Weiss, our CEO.

此外，本次電話會議中所做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更新或修改任何前瞻性陳述的義務。今天的電話會議正在錄製並在 TG 網站 www.tgtherapeutics.com 上進行音頻重播，並將在未來 30 天內提供。現在我想將電話轉給我們的首席執行官邁克·韋斯 (Mike Weiss)。

Thanks, Jenna, and good morning, everyone, and thanks for joining us on today's call. We are excited to present to you our second quarter 2023 financial results, representing the first full quarter of Briumvi sales, which, like the first quarter of 2023 exceeded our expectations. But before I do, I want to kick off today's call by highlighting this morning's news relating to our agreement for ex-U.S. commercialization of Briumvi.

謝謝珍娜，大家早上好，感謝您參加今天的電話會議。我們很高興向您展示 2023 年第二季度的財務業績，代表 Briumvi 第一個完整季度的銷售額，與 2023 年第一季度一樣，超出了我們的預期。但在此之前，我想在今天的電話會議開始前強調一下今天早上與我們達成的協議有關的新聞。 Briumvi 的商業化。

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. Today, we are very happy to announce that we've entered into an ex-U.S. commercialization agreement for Briumvi with Neuraxpharm, a leading European specialty pharmaceutical company focused on the treatment of central nervous system disorders or CNS disorders. We are very excited to be partnering with them to launch Briumvi in Europe. The neurology-focused approach, broad European platform and entrepreneurial organization really resonated with us as an attractive partner for Briumvi and TG.

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。今天，我們非常高興地宣布，我們已經進入了前美國市場。 Briumvi 與 Neuraxpharm 達成商業化協議，Neuraxpharm 是一家歐洲領先的專業製藥公司，專注於治療中樞神經系統疾病或中樞神經系統疾病。我們非常高興能與他們合作在歐洲推出 Briumvi。作為 Briumvi 和 TG 有吸引力的合作夥伴，以神經病學為中心的方法、廣泛的歐洲平台和創業組織確實引起了我們的共鳴。

Neuraxpharm has over 35 years of experience in the CNS space, a direct presence in 20 European countries and an extensive commercial CNS team. And in addition, they have committed to add over 100 additional field-based commercial and medical MS specialists dedicated to Briumvi. Moreover, they have the backing of one of the preeminent global private equity firm is Permira. For all of these reasons, we are confident in their ability to succeed and make Briumvi a leading treatment for patients with RMS worldwide.

Neuraxpharm 在 CNS 領域擁有超過 35 年的經驗，在 20 個歐洲國家設有直接辦事處，並擁有廣泛的 CNS 商業團隊。此外，他們還承諾增加 100 多名專門為 Briumvi 提供現場服務的商業和醫學 MS 專家。此外，他們還得到了全球傑出私募股權公司之一 Permira 的支持。出於所有這些原因，我們對他們的成功能力充滿信心，並使 Briumvi 成為全球 RMS 患者的領先治療方法。

From a deal perspective, the terms provide us with many important benefits that we were seeking when evaluating potential ex-U.S. partnerships including a meaningful upfront payment, which together with a near-term milestone, total over $150 million, solidifying our balance sheet. We're also eligible to receive to an additional $500 million in milestone payments based on the achievement of certain launch and commercial objectives for a total deal value at up to approximately $650 million.

從交易的角度來看，這些條款為我們提供了許多重要的好處，這些好處是我們在評估潛在的美國以外地區時所尋求的。合作夥伴關係包括一筆有意義的預付款，加上近期的里程碑，總額超過 1.5 億美元，鞏固了我們的資產負債表。根據某些發布和商業目標的實現情況，我們還有資格獲得額外 5 億美元的里程碑付款，交易總價值高達約 6.5 億美元。

We will also receive tiered double-digit royalties on net product sales, up to 30%, which we think provide significant participation in the success of Briumvi in Europe and the rest of the world. And lastly and very importantly, as part of the deal, we retained strategic flexibility in the event of an acquisition of TG within the next 2 years with an option to buy back all rights under the commercialization agreement.

我們還將獲得產品淨銷售額的兩位數分級特許權使用費，最高可達 30%，我們認為這對 Briumvi 在歐洲和世界其他地區的成功起到了重要作用。最後也是非常重要的是，作為交易的一部分，如果在未來兩年內收購 TG，我們保留了戰略靈活性，並可以選擇回購商業化協議下的所有權利。

As we noted previously, retaining this type of strategic flexibility was core to our considering an ex-U.S. transaction and Neuraxpharm in their backers appreciated that need. In exchange, Neuraxpharm will have the exclusive right to commercialize Briumvi in territories outside the United States, Canada and Mexico, which we have retained and excluding certain Asian countries, which we had previously partnered.

正如我們之前指出的，保留這種戰略靈活性是我們考慮退出美國市場的核心。交易和 Neuraxpharm 的支持者都意識到了這種需求。作為交換，Neuraxpharm 將擁有在美國、加拿大和墨西哥以外地區商業化 Briumvi 的專有權，我們保留了這些地區，但不包括我們之前合作過的某些亞洲國家。

As I said earlier, we are very excited to partner with Neuraxpharm and believe they are well positioned to successfully launch Briumvi in Europe, which we expect to commence in Germany in the next 6 months. With that, let me touch upon the U.S. Briumvi launch efforts, which remains our primary focus. As a reminder, Briumvi received U.S. FDA approval late last year and officially launched at the end of January of this year as the first and only anti-CD20 monoclonal antibody to treat patients with relapsing forms of MS that can be administered in a 1-hour infusion twice per year following the starting dose.

正如我之前所說，我們非常高興與 Neuraxpharm 合作，並相信他們有能力在歐洲成功推出 Briumvi，我們預計將在未來 6 個月內在德國啟動。接下來，讓我談談美國 Briumvi 的發射工作，這仍然是我們的首要關注點。需要提醒的是，Briumvi 去年年底獲得美國FDA 批准，並於今年1 月底正式上市，是第一個也是唯一一個可在1 小時內給藥的治療復發性多發性硬化症患者的抗CD20 單克隆抗體。起始劑量後每年輸注兩次。

I'm delighted to share that we experienced significant growth in revenues and prescriptions over the first quarter of this year, illustrating what we believe is strong early demand for Briumvi. Equally noteworthy is the breadth of centers and providers willing to embrace this new treatment option, demonstrating the trust and confidence they have in Briumvi and TG.

我很高興地告訴大家，今年第一季度我們的收入和處方數量顯著增長，這說明我們認為對 Briumvi 的早期需求強勁。同樣值得注意的是願意接受這種新治療選擇的中心和提供者的範圍廣泛，這表明了他們對 Briumvi 和 TG 的信任和信心。

Our early performance is a testament to the dedication and passion of our entire TG team who have relentlessly worked to bring Briumvi to patients with RMS. The enthusiasm for Briumvi continues to build and the feedback we have received continues to encourage us that the unique attributes of Briumvi are supportive of its best-in-class potential, including its glycoengineering for efficient B-cell depletion, lowest reported annualized relapse rates of any CD20 monoclonal antibody in MS Phase III trials and a rapid and reliable 1-hour infusion.

我們早期的表現證明了整個 TG 團隊的奉獻精神和熱情，他們堅持不懈地努力將 Briumvi 帶給 RMS 患者。人們對 Briumvi 的熱情不斷高漲，我們收到的反饋繼續鼓勵我們，Briumvi 的獨特屬性支持其一流的潛力，包括其用於高效 B 細胞耗竭的糖工程、報告的最低年復發率MS III 期試驗中的任何CD20 單克隆抗體以及快速可靠的1 小時輸注。

As we move into the third quarter, we believe we are building a solid foundation for future Briumvi growth. We continue to see adoption from both major academic centers and community centers and believe that, that adoption will continue to grow, especially now that we have a permanent J-Code in place and improving insurance coverage for Briumvi. All of these factors, along with the continuing growth of the CD20 market within the overall MS treatment landscape, further strengthen our confidence in the future potential of Briumvi.

隨著進入第三季度，我們相信我們正在為未來的 Briumvi 增長奠定堅實的基礎。我們繼續看到主要學術中心和社區中心的採用，並相信這種採用將繼續增長，特別是現在我們已經制定了永久性 J 代碼並改善了 Briumvi 的保險範圍。所有這些因素，加上 CD20 市場在整個 MS 治療領域的持續增長，進一步增強了我們對 Briumvi 未來潛力的信心。

I'll stop there as our Chief Commercialization Officer, Adam Waldman will join us shortly to provide more detailed launch metrics. But as you can hear, I'm extremely impressed with the progress the team has made to date and look forward to an impactful second half of 2023. Before I turn the call over to Adam, I just want to touch briefly on TG's cash position.

我就講到這裡，作為我們的首席商業化官，Adam Waldman 很快就會加入我們，提供更詳細的發布指標。但正如您所聽到的，我對團隊迄今為止取得的進展印象深刻，並期待著 2023 年下半年的發展。在將電話轉給 Adam 之前，我只想簡單談談 TG 的現金狀況。

Following the Neuraxpharm transaction, we have pro forma cash balance of approximately $285 million. Given our relatively stable OpEx and growing revenues, we believe we now have sufficient capital to fund our operations into the foreseeable future without the need to raise additional capital. Of course, this projection is subject to many variables, but suffice to say, as of today, we are confident with our cash position.

Neuraxpharm 交易後，我們的預計現金餘額約為 2.85 億美元。鑑於我們相對穩定的運營支出和不斷增長的收入，我們相信我們現在有足夠的資本來為可預見的未來的運營提供資金，而無需籌集額外資本。當然，這一預測受到許多變量的影響，但足以說明的是，截至今天，我們對我們的現金狀況充滿信心。

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

接下來，讓我將電話轉給我們的首席商業化官 Adam Waldman，分享我們第一個完整季度發布的一些額外信息。亞當？

Yes. Thank you, Mike, and good morning, everybody. Before I jump into the quarter results in the U.S., let me start by saying how excited I am to be partnering Neuraxpharm, to launch Briumvi in Europe and other markets around the world. They share our entrepreneurial mindset and urgency and will undoubtedly make Briumvi a top priority. From a commercial perspective, I am very impressed with their capabilities, expertise and presence in the neurology space. And I believe they will do an excellent job accelerating the launch and quickly bringing Briumvi to patients around the world.

是的。謝謝你，邁克，大家早上好。在我開始討論美國季度業績之前，我首先要說的是，我很高興能與 Neuraxpharm 合作，在歐洲和世界其他市場推出 Briumvi。他們與我們有著相同的創業心態和緊迫感，毫無疑問，他們將使 Briumvi 成為重中之重。從商業角度來看，他們在神經病學領域的能力、專業知識和存在給我留下了深刻的印象。我相信他們將出色地完成工作，加速上市進程，並迅速將 Briumvi 帶給世界各地的患者。

As far as the U.S. performance in the second quarter, which as Mike mentioned, is our first full quarter in the market. We are very pleased with the progress we're seeing with Briumvi and we continue to exceed our internal expectations. We have built positive momentum in the first half of the year and encouraged by the launch trajectory to date. With second quarter net sales for Briumvi of $16 million, representing over 100% growth quarter-over-quarter. Key highlights from the quarter include increases in patient demand growth where we saw daily average hub enrollment nearly double quarter-over-quarter with greater than 800 Briumvi prescriptions coming through our hub in the second quarter, bringing our launch to date total to more than 1,200 new patient scripts.

至於美國第二季度的表現，正如邁克提到的，這是我們在市場上的第一個完整季度。我們對 Briumvi 所取得的進展感到非常滿意，並且我們將繼續超越我們的內部期望。我們在上半年建立了積極的勢頭，並對迄今為止的發布軌跡感到鼓舞。 Briumvi 第二季度淨銷售額為 1600 萬美元，環比增長超過 100%。本季度的主要亮點包括患者需求增長的增長，我們發現中心的每日平均註冊人數比上一季度幾乎翻了一番，第二季度我們的中心收到了超過800 份Briumvi 處方，使我們迄今為止推出的總數超過1,200 份新的患者腳本。

As we have mentioned in the past, we believe this figure is capturing 80% to 90% of the total new scripts written. And while it is challenging to determine the exact number, we saw dramatic increases in new patient infusions in the second quarter. Importantly, patient and physician feedback continues to be overwhelmingly positive. In our market research, the majority of Briumvi prescribers report having very positive experience so far with nearly all patients completing the 1-hour infusions as expected.

正如我們過去提到的，我們相信這個數字佔了新編寫腳本總數的 80% 到 90%。儘管確定確切數字具有挑戰性，但我們看到第二季度新患者輸液量急劇增加。重要的是，患者和醫生的反饋仍然非常積極。在我們的市場研究中，大多數 Briumvi 處方者表示，到目前為止，幾乎所有患者都按預期完成了 1 小時輸液，獲得了非常積極的體驗。

We also continue to increase our breadth of adoption, adding more than 100-plus incremental accounts and over 170 incremental prescribers, bringing the total to over 225 accounts and over 340 prescribers launched to date. This includes both academic and community centers across all regions of the U.S. At this point, we have seen a high percentage of our initially targeted accounts prescribed Briumvi and we intend to broaden our focus in the second half of the year.

我們還繼續擴大採用範圍，增加了 100 多個增量賬戶和 170 多名增量處方者，使迄今為止推出的賬戶總數超過 225 個，處方者超過 340 名。這包括美國所有地區的學術和社區中心。目前，我們已經看到我們最初的目標賬戶中有很大一部分使用了 Briumvi，我們打算在今年下半年擴大我們的關注範圍。

We also continue to see broad utilization across patient types, including newly diagnosed and switches that are both new to CD20 and from other CD20s. Importantly, we have received -- we have -- importantly, the feedback we have received from customers on the unique profile of Briumvi continues to be encouraging. We routinely hear that the predictability of the 1-hour infusion combined with the annualized relapse rate of less than 0.1 are important differentiators for Briumvi. Through our market research, we have also found the vast majority of Briumvi prescribers plan to increase their use of Briumvi over the next 6 months.

我們還繼續看到跨患者類型的廣泛利用，包括新診斷的患者以及 CD20 和其他 CD20 的新轉換。重要的是，我們從客戶那裡收到的關於 Briumvi 獨特形象的反饋仍然令人鼓舞。我們經常聽說 1 小時輸注的可預測性加上低於 0.1 的年復發率是 Briumvi 的重要差異化因素。通過我們的市場研究，我們還發現絕大多數 Briumvi 處方者計劃在未來 6 個月內增加 Briumvi 的使用。

We've launched with a focused strategy to maximize our market opportunity with a nimble and experienced team who are producing early results. Neurologists perceptions of TG rep performance is outstanding and outpaces our competition on almost all attributes. The team is actively engaging with accounts and has shown strong share of voice among customers on par with leading MS therapies. I'm extremely proud of the team's performance to date and their continued commitment to the MS community.

我們推出了一項重點戰略，通過一支靈活且經驗豐富的團隊來最大化我們的市場機會，他們正在取得早期成果。神經科醫生對 TG 代表表現的看法非常出色，幾乎在所有方面都超過了我們的競爭對手。該團隊積極與客戶互動，並在客戶中表現出與領先的多發性硬化症療法相當的強大話語權。我對團隊迄今為止的表現以及他們對 MS 社區的持續承諾感到非常自豪。

Our growing patient demand in the form of enrollment and new patient infusions increasing breadth of adoption by prescribers and centers and an effective J-Code as of July 1, we believe puts us in great position into the -- going into the second half of the year. I'm also very pleased to report that we now have achieved payer coverage for approximately 80% of commercial and Medicare lives, giving us coverage for Briumvi at parity with Ocrevus across the vast majority of these plans.

我們不斷增長的患者需求（以入組和新患者輸液的形式增加了處方醫生和中心的採用範圍，以及自7 月1 日起有效的J 代碼），我們相信，這使我們處於有利的地位-進入下半年年。我還非常高興地向大家報告，我們現在已經實現了約 80% 的商業和醫療保險生活的付款人承保，使我們在絕大多數計劃中對 Briumvi 的承保與 Ocrevus 持平。

If you recall, our corporate goal was to achieve 80% coverage by the end of the year. So accomplishing that by midyear far exceeds our expectations and is a testament to the attractiveness of Briumvi to payers and the strong efforts of our market access team. We also made solid progress in the quarter, securing additional institutional formulary coverage. While many of these institutions have been slower moving than we had anticipated, we expect they will increase adoption into the second half of the year. So following a strong start in Q1, this was another very solid quarter for the Briumvi launch.

如果您還記得的話，我們的公司目標是到年底實現 80% 的覆蓋率。因此，到年中實現這一目標遠遠超出了我們的預期，證明了 Briumvi 對付款人的吸引力以及我們市場准入團隊的大力努力。我們在本季度也取得了紮實的進展，確保了更多的機構處方覆蓋範圍。儘管其中許多機構的行動速度比我們預期的要慢，但我們預計它們將在今年下半年增加採用率。因此，繼第一季度強勁開局之後，Briumvi 的發布又迎來了一個非常穩健的季度。

We continue to make progress across all fronts and believe Briumvi offers a best-in-class profile. We continue to see MS specialists expand their use of CD20s and anticipate this trend will continue given the therapeutic index of the drugs in this class and further believe IV therapies will continue to lead the market. We now have a permanent J-Code in effect, which helps on reimbursement. Payer coverage is significantly ahead of schedule and major health systems have added and are continuing to add Briumvi to their formularies. While we still have a lot of work to do, we are really pleased with the progress we have made in Q2.

我們繼續在各個方面取得進展，並相信 Briumvi 提供一流的形象。我們繼續看到多發性硬化症專家擴大 CD20 的使用，鑑於此類藥物的治療指數，預計這一趨勢將繼續下去，並進一步相信靜脈注射療法將繼續引領市場。我們現在擁有有效的永久 J 代碼，這有助於報銷。付款人覆蓋範圍大大提前，主要衛生系統已經並將繼續將 Briumvi 添加到其處方集中。雖然我們還有很多工作要做，但我們對第二季度取得的進展感到非常滿意。

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首席財務官 Sean Power。

Thank you, Adam, and thanks, everyone, for joining us. Earlier this morning, we reported our detailed second quarter 2023 financial results, which can be viewed on the Investors & Media section of our website. I'd like to begin today's call by touching on our cash position. As we released earlier this morning and highlighted by Mike, we are pleased to report that the ex-U.S. commercialization agreement with Neuraxpharm contains an upfront cash payment of $140 million and additional near-term cash milestones of approximately $12.5 million.

謝謝你，亞當，也謝謝大家加入我們。今天早上早些時候，我們報告了詳細的 2023 年第二季度財務業績，您可以在我們網站的投資者與媒體部分查看該業績。我想在今天的電話會議開始時談談我們的現金狀況。正如我們今天早上早些時候發布並由邁克強調的那樣，我們很高興地報告，前美國。與 Neuraxpharm 的商業化協議包含 1.4 億美元的預付款現金和約 1250 萬美元的額外近期現金里程碑。

During the second quarter, we were also able to take advantage of favorable market conditions to bolster our balance sheet and raised approximately $46 million in net proceeds from the utilization of our ATM facility at an average price of approximately $34. All told, we ended the second quarter with approximately $145 million in cash. And when accounting for the $140 million upfront payment, I have a current pro forma cash balance of approximately $285 million.

在第二季度，我們還能夠利用有利的市場條件來增強我們的資產負債表，並通過使用 ATM 設施以平均價格約 34 美元的價格籌集約 4600 萬美元的淨收益。總而言之，我們第二季度末的現金約為 1.45 億美元。考慮到 1.4 億美元的預付款，我目前的預計現金餘額約為 2.85 億美元。

We believe our current capital when coupled with modest Briumvi revenue assumptions, will take us out into the foreseeable future without the need to raise incremental capital.

我們相信，我們目前的資本加上適度的 Briumvi 收入假設，將使我們在可預見的未來無需籌集增量資本。

Turning to some of the other key financial metrics for the quarter. First, as Adam previously reported, we are pleased to announce $16 million in Briumvi net sales in our first full quarter since launch, representing 100% growth over the first quarter of 2023 and $23.8 million in cumulative net sales since launch. As for our broader financial results, our net loss for the second quarter of 2023 excluding noncash items, was approximately $35.1 million, roughly in line with the first quarter of 2023, where we saw a net loss of $32.4 million when excluding noncash items.

轉向本季度的一些其他關鍵財務指標。首先，正如Adam 之前報導的那樣，我們很高興地宣布，Briumvi 自推出以來第一個完整季度的淨銷售額為1600 萬美元，較2023 年第一季度增長100%，自推出以來累計淨銷售額為2380 萬美元。至於我們更廣泛的財務業績，我們2023 年第二季度（不包括非現金項目）的淨虧損約為3510 萬美元，與2023 年第一季度（不包括非現金項目時的淨虧損3240 萬美元）大致一致。

Our GAAP net loss for the second quarter of 2023 was approximately $47.6 million or $0.34 per share compared to a GAAP net loss of $40.5 million or $0.30 per share in the second quarter of 2022.

我們 2023 年第二季度的 GAAP 淨虧損約為 4760 萬美元，即每股 0.34 美元，而 2022 年第二季度的 GAAP 淨虧損為 4050 萬美元，即每股 0.30 美元。

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

現在，我將把電話轉回給會議接線員以開始問答。

(Operator Instructions) Our first question is from Eric Joseph with JP Morgan.

（操作員說明）我們的第一個問題來自摩根大通的埃里克·約瑟夫（Eric Joseph）。

Can you talk a little bit about the cadence of new prescriptions for Briumvi over the course of 2Q and throughout July to date. I'm curious to know whether the demand curve is accelerating, plateauing, is it choppy? And then are you seeing a material impact so far from -- now having the J-Code in place.

您能談談第二季度和整個 7 月至今 Briumvi 新處方的節奏嗎？我很好奇需求曲線是否正在加速、趨於穩定、是否波動？然後，您是否會看到到目前為止 J 代碼到位所帶來的實質性影響。

Yes. Thanks, Eric. Adam, you want to go ahead and back along.

是的。謝謝，埃里克。亞當，你想要前進和後退。

Yes. I would characterize it as steady growth. And I would say we saw a little bit of a slowdown in the July 4th week, which is a down week, I think, across the board. We've seen acceleration since. That said, we wouldn't expect an immediate impact on the J-Code. It takes time for this J-Code to get loaded into payer systems, loaded into the institutional systems. We do believe it's a net positive. We do believe that it will lead to continued growth and will lead to more pickup for Briumvi, but it will take time, as I think I've said in the past.

是的。我將其描述為穩定增長。我想說的是，7 月 4 日這一周我們看到了一點放緩，我認為這是全面下滑的一周。從那以後我們看到了加速發展。也就是說，我們預計 J 代碼不會立即受到影響。該 J 代碼需要時間才能加載到付款人系統、加載到機構系統中。我們確實相信這是一個淨積極的結果。我們確實相信，這將帶來持續增長，並將為 Briumvi 帶來更多的銷量，但這需要時間，正如我過去所說的那樣。

Okay. That's helpful. And maybe just a follow-up, if I could. Just when it comes to your updated cash guidance, right, have it being funded through operations for the foreseeable future. Can you just talk about what that encompasses, if anything beyond Briumvi commercialization in the U.S.? Does it anticipate any further development of the product perhaps for other indications or formulations.

好的。這很有幫助。如果可以的話，也許只是一個後續行動。當談到更新的現金指導時，對吧，在可預見的未來通過運營為其提供資金。您能談談這其中包含的內容嗎？除了 Briumvi 在美國的商業化之外還有什麼內容嗎？它是否預計該產品可能針對其他適應症或配方進行任何進一步開發？

Yes. Thanks, Eric. So yes, it does mean we are continuing to evaluate the subcu formulation of Briumvi. So that's also included in that. We've got our eye on potentially additional clinical studies for Briumvi. We've got some of them, we obviously have the BTK inhibitor in our portfolio that we're evaluating. We're kind of waiting to see what the data looks like from some of the competitive products to see if there's an avenue for us to move forward there. And we've said and we continue to be active in looking at new opportunities and all of that would be included in that cash guidance, yes. None of it would be so material to impact where we're going, which appears to be quarter-over-quarter, our net loss should continue to decline.

是的。謝謝，埃里克。所以，是的，這確實意味著我們正在繼續評估 Briumvi 的 subcu 配方。所以這也包括在其中。我們正在關注 Briumvi 可能進行的額外臨床研究。我們已經有了其中一些，顯然我們正在評估的產品組合中有 BTK 抑製劑。我們正在等待查看一些競爭產品的數據，看看我們是否有前進的途徑。我們已經說過，我們將繼續積極尋找新的機會，所有這些都將包含在現金指導中，是的。所有這些都不會對我們的發展方向產生重大影響，這似乎是季度環比，我們的淨虧損應該會繼續下降。

And our next question is from Ed White with H.C. Wainwright.

我們的下一個問題來自 Ed White 和 H.C.溫賴特。

Congratulations on the second quarter sales and also on the deal announced this morning.

祝賀第二季度的銷售以及今天早上宣布的交易。

Just 2 questions for me. First, Mike, I just wanted to get your thoughts on the Ocrevus subcutaneous Phase III data and the potential impact that will have on the market and where you are as far as you had just mentioned your subcutaneous formulation.

只需問我 2 個問題。首先，邁克，我只是想了解您對 Ocrevus 皮下 III 期數據的看法，以及對市場和您剛才提到的皮下製劑的潛在影響。

And then the second question I have is just for Sean, the R&D was up dramatically sequentially in the second quarter. I just wanted to get your thoughts on R&D expenses over the second half of the year.

我的第二個問題是問肖恩的，第二季度的研發工作連續大幅增長。我只是想了解一下大家對下半年研發費用的看法。

Yes. So the Ocrevus subcu. So a few points on that. Obviously, it's made somewhat of a splash among the investment community, which I find interesting in that it wasn't a surprise, right? This has been telegraphed for quite some time that this data was coming. I think the data that they presented is in line with what one would expect from a top line data release. I do think that the details let's say, (inaudible) in the details. We all look forward to seeing the detailed data presentation.

是的。所以Ocrevus subcu。所以有幾點。顯然，這在投資界引起了一定的轟動，我覺得這很有趣，因為這並不令人意外，對吧？很長一段時間以來，人們一直在暗示該數據即將到來。我認為他們提供的數據符合人們對頂線數據發布的預期。我確實認為細節可以說，（聽不清）在細節中。我們都期待看到詳細的數據呈現。

I do know that there's a pain measure, I think, is a co-primary endpoint. So we'll be interested to see what that pain level looks like. Anecdotally, we have heard that pain associated with the subcu can be significant in some patients. So I think we're all in a position of waiting to see what the actual profile of that product looks like. I think as we sit here today, Briumvi with its 1-hour infusion is the gold standard for convenience and efficacy in the CD20 space. And I think the fact that folks are excited and potentially interested and the fact that Roche is excited and interested in a faster and more convenient, call it, "infusion options" since it's not a rapid infusion -- it's not a simple subcu similar to Kesimpta, but it's a process which will take 10 to 15 minutes.

我確實知道有一個疼痛衡量標準，我認為是一個共同主要終點。所以我們有興趣看看疼痛程度是什麼樣的。有趣的是，我們聽說某些患者與皮下組織相關的疼痛可能很嚴重。因此，我認為我們都在等待該產品的實際情況。我認為，當我們今天坐在這裡時，Briumvi 及其 1 小時輸液是 CD20 領域便利性和功效的黃金標準。我認為人們很興奮並且可能感興趣，羅氏也對更快、更方便的“輸注選擇”感到興奮和感興趣，因為它不是快速輸注——它不是一個簡單的subcu，類似於Kesimpta，但這個過程需要10 到15 分鐘。

It will require significant nursing attention to get that in, which we think also will deter from centers getting too excited potentially about using it as a more efficient product. There's nothing more efficient than setting up an hour infusion for multiple patients and sitting there. So we do think that the Briumvi is setting the standard. We're excited that investors and our competitors are excited about trying to improve the patient experience and try to compete with us in that patient experience. But for the next year or more, we're going to have a monopoly on that part of the market and potentially longer, and we'll see what their product looks like.

需要大量的護理關注才能將其納入其中，我們認為這也將阻止中心對將其用作更有效的產品過於興奮。沒有什麼比為多名患者安排一個小時的輸液並坐在那裡更有效的了。因此，我們確實認為 Briumvi 正在製定標準。我們很高興投資者和我們的競爭對手對改善患者體驗感到興奮，並嘗試在患者體驗方面與我們競爭。但在接下來的一年或更長時間裡，我們將壟斷這部分市場，甚至可能更長時間，我們將看看他們的產品是什麼樣子。

So I think overall to us, it's all net positive. I think it highlights the fact that -- there is a need in the marketplace for a more convenient product and Briumvi is the gold standard today.

所以我認為總的來說對我們來說，這都是淨積極的。我認為它凸顯了這樣一個事實：市場需要一種更方便的產品，而 Briumvi 是當今的黃金標準。

Sean, do you want to tackle that R&D difference.

肖恩，你想解決研發差異嗎？

Yes, sure. Thanks for the question. The increase in R&D over the first quarter of '23 relates primarily to a milestone due to LFP on the EU approval of Briumvi, $6 million.

是的，當然。謝謝你的提問。 23 年第一季度研發的增長主要與 LFP 歐盟批准 Briumvi 的里程碑有關，金額為 600 萬美元。

And our next question is from Roger Song with Jefferies.

我們的下一個問題來自 Jefferies 的 Roger Song。

Great. Maybe, Mike, if you can you give us a little bit of color around the ex-U.S. deal regarding the buyback options, what's the term associated. For example, what will be the valuation for the buyback? And would that be tied to the commercialization results?

偉大的。也許，邁克，如果可以的話，你可以給我們一些關於美國以外的地方的色彩。關於回購選項的交易，相關術語是什麼。例如，回購的估值是多少？這會與商業化結果掛鉤嗎？

Sure. Thanks for the question, Roger. So Yes, the buyback option is basically designed to provide Neurax a return essentially on investment. So whatever they pay us, we basically will pay them back that amount plus a return on their investment. So we think it's a very reasonable approach. I think it accounts for the risk that they're taking in building out what they need to build out to commercialize and building out the market for us and then losing that. But it's also not punitive at all that would inhibit our ability to conduct a strategic transaction.

當然。謝謝你的提問，羅傑。所以，是的，回購選項基本上旨在為 Neurax 提供基本的投資回報。因此，無論他們付給我們什麼，我們基本上都會償還他們的金額加上他們的投資回報。所以我們認為這是一個非常合理的方法。我認為這解釋了他們在構建商業化所需的東西並為我們構建市場時所承擔的風險，然後又失去了這個風險。但這也根本不是懲罰性的，會抑制我們進行戰略交易的能力。

Got it. Yes. That's helpful. And then in terms of the sales we all track IQVIA and the Symphony seems the number in terms of dollar value pretty on track from at least from Symphony. So we know your market this through the specialty and that you have your own hub. So how should we think about reconsolidation of marketable third-party database versus your Q-on-Q sales number?

知道了。是的。這很有幫助。然後就銷售額而言，我們都跟踪 IQVIA 和 Symphony，從美元價值來看，至少從 Symphony 來看，這個數字相當不錯。因此，我們通過專業了解您的市場，並且您擁有自己的中心。那麼，我們應該如何考慮可銷售的第三方數據庫與 Q-on-Q 銷售數據的重新整合呢？

Yes. So I'll take a quick crack at this, and I'll let Adam talk -- speak on this as well. But we've been cautioning all along that trying to create some sort of reconciliation between Symphony or IQVIA and our numbers at this point is not a useful endeavor. We have said that we believe that over time, once we have several quarters to maybe more than several quarters, of utilization that will reach what I've described as steady state. And at that point, I think people can probably take that data and try to use a multiplier effect or some sort of algorithm to calculate what the sales are going to be.

是的。所以我會快速解決這個問題，然後我會讓 Adam 談談——也談談這個問題。但我們一直在警告，目前試圖在 Symphony 或 IQVIA 與我們的數據之間建立某種協調並不是一項有用的努力。我們說過，我們相信隨著時間的推移，一旦我們有幾個季度甚至超過幾個季度的時間，利用率將達到我所說的穩定狀態。到那時，我認為人們可能可以利用這些數據並嘗試使用乘數效應或某種算法來計算銷售額。

But since we're so early in the launch, I think that's a pretty dangerous game to play and we've warned everyone multiple times publicly in every setting we can that, that's not a good idea at this point to try to gauge. Having said that, we -- sales for the -- the net sales for the quarter were ahead of our expectations -- were ahead of all of Wall Street's expectations, honestly, until about 2 days ago. So we think it was a very good quarter. We're obviously super excited about it. We're right on track of where we want to be. So it's obviously a little disheartening when folks somehow changed the consensus 2 days before the reporting and then assume that it was a bad quarter.

但由於我們還處於發布初期，我認為這是一個非常危險的遊戲，我們已經在我們可以做到的每一個環境中多次公開警告大家，在這一點上嘗試評估並不是一個好主意。話雖如此，我們——本季度的銷售額——淨銷售額超出了我們的預期——老實說，直到大約兩天前，我們都領先於華爾街的所有預期。所以我們認為這是一個非常好的季度。我們顯然對此感到非常興奮。我們正朝著我們想要達到的目標前進。因此，當人們在報告發布前兩天以某種方式改變了共識，然後認為這是一個糟糕的季度時，這顯然有點令人沮喪。

And similarly to use Symphony numbers to try to gauge what that sales number is going to be, again, I just -- like I said, we find that to be a very dangerous game to play and we've said that multiple times. On that note, I'll let Adam add some more color there.

與使用 Symphony 數字來嘗試衡量銷售數字類似，我只是——就像我說的那樣，我們發現這是一個非常危險的遊戲，我們已經說過很多次了。關於這一點，我會讓 Adam 在那裡添加更多顏色。

Sure. I mean, Roger, thanks for the question. If you look at other IV products, including in the MS space, you'll see the ratio between Symphony and IQVIA and reported net sales is often highest in the launch quarter. I think it can be -- and it does come down often. As we said, it can be perhaps helpful in understanding directional trends, but it does a poor job capturing launch dynamics that all new products experience. And as I've said and I think Mike has said, it doesn't capture sales through our direct channel. We've also said that, that's going to be highly variable quarter-to-quarter, especially in the beginning as people figure out how they want to purchase. And that will also impact the ratio between Symphony sales and net sales. So again, we recommend not using Symphony or IQVIA as a way to estimate our quarterly net sales going forward. And I hope that helps.

當然。我的意思是，羅傑，謝謝你的提問。如果您查看其他 IV 產品，包括 MS 領域的產品，您會發現 Symphony 和 IQVIA 之間的比率，並且報告的淨銷售額通常在發布季度最高。我認為它可以——而且它確實經常下降。正如我們所說，它可能有助於理解方向趨勢，但它在捕捉所有新產品都會經歷的發布動態方面表現不佳。正如我說過的，我想邁克也說過，它並沒有通過我們的直接渠道獲得銷售。我們還說過，每個季度的情況都會有很大的變化，尤其是在人們弄清楚他們想要如何購買的開始階段。這也將影響 Symphony 銷售額與淨銷售額之間的比率。因此，我們再次建議不要使用 Symphony 或 IQVIA 來估計我們未來的季度淨銷售額。我希望這會有所幫助。

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。

Just to quickly follow up on questions previously asked. If you could comment on inventory on average, helped by distributors and offices? And also on those -- some of those launch metrics, what percentage you're tracking for free drug sampling. And lastly, if you could comment on the TRx volumes lead between newly diagnosed versus switch patients that would be super helpful.

只是為了快速跟進之前提出的問題。您是否可以在經銷商和辦事處的幫助下對平均庫存進行評論？還有一些 - 一些發布指標，您正在跟踪免費藥物採樣的百分比。最後，如果您能評論新診斷患者與轉換患者之間的 TRx 量領​​先情況，那將非常有幫助。

Adam, do you want to tackle this one?

亞當，你想解決這個問題嗎？

Sure. I mean inventory is within industry standards. There's no surprises there and pretty much what you would expect. As far as the free goods, we had free goods of about 20% in the quarter. The majority of that is through our Quick Start program. And as we said before, that is a program to get patients started and eventually, our hope is that they would convert to commercial product at some point in the future. And then as far as the patient mix, we haven't said we're still not in a position yet, I don't think, to comment on the percentages. But what we have said is we've seen a nice distribution across all 3 segments, both newly diagnosed and switches, both from CD20s and non-CD20.

當然。我的意思是庫存符合行業標準。那裡沒有什麼驚喜，幾乎符合你的預期。就免費商品而言，本季度我們有大約 20% 的免費商品。其中大部分是通過我們的快速啟動計劃實現的。正如我們之前所說，這是一個讓患者開始的計劃，最終我們希望他們能夠在未來的某個時候轉化為商業產品。然後就患者組合而言，我認為我們還沒有能夠對百分比發表評論。但我們所說的是，我們在所有 3 個細分市場中都看到了良好的分佈，包括新診斷的和轉換的、來自 CD20 和非 CD20 的。

Great. And maybe, Mike, if you could comment on the bidding process for the ex-U.S. deal and would be really helpful to understand how much the sort of competitive nature of MS marketplace especially in context of BTK inhibitors coming down the pipe? And also, obviously, you commented on subcu, -- like how much of that is sort of part of that discussion because obviously, your partners or future even strategics would want to incorporate that as part of the long-range planning.

偉大的。邁克，也許你可以評論一下美國以外的申辦過程。交易，對於了解 MS 市場的競爭性質有多大，尤其是在 BTK 抑製劑即將上市的情況下，真的很有幫助？而且，顯然，您對 subcu 發表了評論，就像其中有多少是討論的一部分，因為顯然，您的合作夥伴或未來甚至戰略都希望將其納入長期規劃的一部分。

Yes. Thanks. So yes, so look, we've said for quite a while that we're going to do the analysis on whether we should go to loan in Europe or we should seek a partner to help us evaluate that and make that decision. We engaged with JPMorgan to run a -- what I think was a very professional, very competitive process to see what kind of economics we can get on an ex-U.S. deal. It was a competitive process.

是的。謝謝。所以，是的，所以看，我們已經說過很長一段時間了，我們將分析我們是否應該在歐洲貸款，或者我們應該尋找合作夥伴來幫助我們評估並做出決定。我們與摩根大通合作運行了一個——我認為這是一個非常專業、非常有競爭力的過程，以了解我們可以從美國以外的國家獲得什麼樣的經濟效益。交易。這是一個競爭的過程。

Neuraxpharm was clearly the most eager and hungry and provide us with the best economic terms, but also, we felt the best overall terms in terms -- especially with respect to the strategic flexibility that the deal offers us, so the combination of the deal terms, the economic terms plus the buyback option really made the Neuraxpharm, the top choice. And I think culturally, they're a great fit with us. I think we'll be able to work closely with them. And I think we can help them with what we've learned in the U.S. And I think in terms of their ability to execute on this plan, we're feeling very confident and very good about it. So really, to us, the deal kind of offers us everything we wanted. It's almost a hybrid way of getting Briumvi to the market as quickly as possible without cutting off our strategic options.

Neuraxpharm 顯然是最渴望和渴望的，為我們提供了最好的經濟條款，而且，我們也感受到了最好的整體條款——特別是在交易為我們提供的戰略靈活性方面，因此交易條款的組合，經濟條件加上回購選項確實使Neuraxpharm 成為首選。我認為從文化上來說，他們非常適合我們。我認為我們將能夠與他們密切合作。我認為我們可以利用我們在美國學到的知識來幫助他們。我認為就他們執行該計劃的能力而言，我們對此感到非常有信心並且非常滿意。事實上，對我們來說，這筆交易為我們提供了我們想要的一切。這幾乎是一種混合方式，可以在不切斷我們戰略選擇的情況下盡快將 Briumvi 推向市場。

So that was the process, and like I said, is very competitive. In terms of the BTKs or the subcu, I think most folks are quite comfortable with the what that competitive landscape is going to look like in the future in terms of the real risk of BTK and the real risk of subcu. So I don't think that was a major consideration in the process.

這就是整個過程，就像我說的，競爭非常激烈。就 BTK 或 subcu 而言，我認為大多數人都對 BTK 的真實風險和 subcu 的真實風險方面未來的競爭格局感到非常滿意。所以我認為這不是這個過程中的主要考慮因素。

Maybe just one more question, Mike. On the guidance, at some point, I think you had mentioned you might be 1, 2, 3 quarters away from maybe having a good idea of what demand looks like to be able to put out a guidance number, like I would love to hear your most recent thoughts on that and if that could come into the picture at some point.

也許還有一個問題，邁克。關於指導，在某些時候，我想你已經提到過，你可能需要 1、2、3 個季度才能很好地了解需求，才能發布指導數字，就像我很想听到的那樣你最近對此的想法以及是否會在某個時候出現。

Yes. I mean in terms of U.S. revenue guidance, Mayank? And when we may be in a position to do that?

是的。我的意思是就美國收入指引而言，Mayank？我們什麼時候可以做到這一點？

Yes I think we are -- and what I've said in the past is probably going into next year, we'll be in a much better position to give some sort of guidance. I think for the remainder of this year, we're going to keep to ourselves, and we're going to keep working on it. But I think, like I said, this quarter, we exceeded our expectations, we exceeded the Street expectations until about 2 days ago when they change. But short of that, we feel like we're on track and we're doing great in terms of where we're heading. But yes, my guess is that we'll probably wait to get this whole year under our belt, we'll get a good sense of how the sales are tracking. One we'll have -- we'll know how many -- at that point, we'll know how many patients we treated in 2023, which will give us a base case for 2024.

是的，我認為我們是——而且我過去所說的可能會持續到明年，我們將處於更好的位置來提供某種指導。我認為在今年剩下的時間裡，我們將保持沉默，並繼續努力。但我認為，就像我說的，這個季度，我們超出了我們的預期，我們超出了華爾街的預期，直到大約兩天前他們發生了變化。但除此之外，我們感覺我們已經步入正軌，並且在我們前進的方向上做得很好。但是，是的，我的猜測是，我們可能會等待一整年的時間，我們會很好地了解銷售情況。我們將會有一個——我們會知道有多少——到那時，我們就會知道我們在 2023 年治療了多少患者，這將為我們提供 2024 年的基本情況。

We'll know where we are in terms of new patient starts in the fourth quarter of '23, which will help us start to think about what the first quarter of '24 will look like in terms of new patient starts. So I think we'll just have a lot more information to be in a better position to do that. We'll also understand the dynamics. We're still so early on in this process.

我們將在 23 年第四季度了解新患者入院情況，這將幫助我們開始思考 24 年第一季度新患者入院情況。因此，我認為我們將獲得更多信息，以便能夠更好地做到這一點。我們還將了解動態。我們還處於這個過程的早期階段。

We don't have the full dynamics of prescription to the hub to total prescriptions to total infusions, right? So because at the early phases, we're going to be -- it's going to take longer to go from prescription to vein as that compresses over the next few quarters. Then once we have that 2-set information also, that will help us give a better sense of how long and where those revenues are going to fall. So I just think it's so early. We're literally in our first full quarter. I think we're quite happy.

我們沒有從處方到中心到總處方到總輸液的完整動態，對嗎？因此，因為在早期階段，隨著未來幾個季度的壓縮，從處方到靜脈注射將需要更長的時間。一旦我們也掌握了這兩組信息，這將幫助我們更好地了解這些收入將下降多長時間以及在哪裡下降。所以我只是覺得現在還太早。我們確實進入了第一個完整季度。我想我們還是挺幸福的

Again, we've got a lot of sensors that have tried the drug. We've got a lot of physicians who have tried the drug. And things are going quite well, and there's so much untapped potential here even within those centers, many of those centers have multiple providers and perhaps only 1 or 2 of those providers are already involved in Briumvi, we think that, that should grow. And there's still unfortunately, and I think Adam touched on this. There's still many centers where the formulary -- internal formulary process just takes much longer than we anticipated.

同樣，我們有很多傳感器已經嘗試過這種藥物。我們有很多醫生嘗試過這種藥物。事情進展順利，即使在這些中心內，也有很多未開發的潛力，其中許多中心有多個提供商，也許只有 1 或 2 個提供商已經參與了 Briumvi，我們認為，這一數字應該會增長。不幸的是，我認為亞當也談到了這一點。仍然有許多中心的處方——內部處方流程比我們預期的要長得多。

So there's a lot of major centers that are still yet to be able to prescribe Briumvi. So we think that's a nice area that we'll see some nice growth going forward. So again, I think we're on the right trajectory that we expected. And when we get to the end of the year, as we get into next year, I think we'll be in a better position to give some guidance.

因此，有很多主要中心仍無法開出 Briumvi 處方。因此，我們認為這是一個很好的領域，我們將看到未來的一些良好增長。再說一次，我認為我們正走在我們預期的正確軌道上。當我們到了今年年底，當我們進入明年時，我認為我們將能夠更好地提供一些指導。

Makes a lot of sense. Again, congrats on the progress and look forward to an equally exciting second half.

很有道理。再次祝賀取得的進展，並期待同樣令人興奮的下半場。

Thanks, Mayank. I appreciate it.

謝謝，瑪雅克。我很感激。

Our next question is from Michael DiFiore with Evercore.

我們的下一個問題來自 Evercore 的 Michael DiFiore。

Congrats all the progress. A few for me. Number 1, like how should we think about uptake adoption in the EU, just considering the back-end loaded nature of the deal? And I have 2 follow-ups.

祝賀所有的進步。給我幾個。第一，僅考慮交易的後端負載性質，我們應該如何考慮歐盟的採用情況？我還有 2 個後續行動。

Yes. So Adam, do you want to talk about uptake in adoption in EU.

是的。亞當，你想談談歐盟的收養情況嗎？

Yes. Michael, thanks for the question. As you know, Europe is -- it's a country-by-country approach, each country having a slightly different reimbursement time line. And I think Germany is first and then we will layer in other countries as they come aboard from a reimbursement standpoint. So that process does take some time and will play out over the next year to 2 in terms of getting up to full speed in Europe. Hopefully, that answers the question.

是的。邁克爾，謝謝你的提問。如您所知，歐洲是一種逐個國家的方法，每個國家的報銷時間表略有不同。我認為德國是第一個，然後我們將在其他國家從報銷的角度加入時加入。因此，這個過程確實需要一些時間，並將在明年到 2 月在歐洲全速發展。希望這能回答問題。

Okay. Also separately, in the past, you said that among MS patients opting for anti-CD20 treatments roughly 30% prefer subcu. My question is, how do you see this changing over the next 12 months as Alzheimer's therapy is gradually encroach on the infusion share capacity. Could this 30% figure increase as it gets harder and hard for patients to schedule share time?

好的。另外，您過去曾說過，在選擇抗 CD20 治療的多發性硬化症患者中，大約 30% 更喜歡 subcu。我的問題是，隨著阿爾茨海默病治療逐漸蠶食輸液份額能力，您如何看待未來 12 個月內這種變化。隨著患者越來越難以安排分享時間，這個 30% 的數字還會增加嗎？

Yes. I mean I think that plays into the Briumvi value proposition. So again, if you're an infuser, you want to optimize your infusion suite. And so I would assume instead of sending out patients for subcu, you prefer to keep them in-house. Again, there's a lot of good reasons that I hear it all the time. The doctors want to know the patient is getting the infusion. So the sending out for subcu, we think is not the first alternative. We think the first alternative is going to be switching all your patients from Ocrevus to Briumvi to free up the chair time and see how that goes. But again, we think this is something that will really play into our favor. I mean I assume there will be some uptick in subcu as a result, but I also think there will be a nice uptick in Briumvi use for that same very reason.

是的。我的意思是，我認為這符合 Briumvi 的價值主張。再說一遍，如果您是輸液器，您需要優化您的輸液套件。因此，我認為您寧願將患者留在內部，而不是派出患者進行 subcu。再說一遍，我經常聽到這樣的說法有很多充分的理由。醫生想知道病人正在接受輸液。因此，我們認為發送 subcu 並不是第一個選擇。我們認為第一個替代方案是將所有患者從 Ocrevus 切換到 Briumvi，以騰出主席時間，看看情況如何。但我們再次認為這確實對我們有利。我的意思是，我認為 subcu 的使用會因此而有所增加，但我也認為出於同樣的原因，Briumvi 的使用也會有很好的增加。

And again, if you're -- you're going to optimize your infusion suite to the best that you can and certainly moving patients from Ocrevus to Briumvi in that setting, if that's what you're trying to achieve and getting more patients in, then we think that's a nice tailwind for us.

再說一次，如果你——你將盡你所能優化你的輸液套件，並且肯定會在這種情況下將患者從Ocrevus 轉移到Briumvi，如果這就是你想要實現的目標並讓更多患者接受治療，那麼我們認為這對我們來說是一個很好的推動力。

Finally, just any comments on gross to net metrics during Q2. Has it changed from the 70% to 75% that you cited in Q1?

最後，只是對第二季度毛淨指標的任何評論。它是否從您在第一季度提到的 70% 變為 75%？

I know it was largely -- yes, it was largely in line with Q1.

我知道這很大程度上與第一季度一致。

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。

So I had a question on the quarter. The 800 prescriptions in the Briumvi hub that you reported in 2Q. So there seems to be a lag between prescriptions and the revenue reported. So could you help us bridge that gap? What is causing the lag? Is it percentage paid RXs. Gross to net seems to be stable. So like any color you could provide on that? And would you expect permanent J-Code to improve the conversion from prescriptions to patient infusions? And I had a follow-up.

所以我有一個關於本季度的問題。您在第二季度報告的 Briumvi 中心有 800 個處方。因此，處方和報告的收入之間似乎存在滯後。那麼您能幫助我們彌合這一差距嗎？是什麼導致了滯後？是按百分比支付的 RX。毛淨值似乎穩定。那麼你可以提供任何顏色嗎？您是否期望永久 J 代碼能夠改善從處方到患者輸液的轉換？我有一個後續行動。

Adam, do you want to take a crack?

亞當，你想嚐嚐嗎？

Sure. Yes. Thanks for the question. I think as we said in the past, there is a time lag between when a script comes into the hub and when you get the actual infusion. I believe what we said is even Ocrevus that's 5 years into the market, they're averaging around 6 weeks. We continue to look at our time frame and it's in that range. And hopefully, we'll compress over time as we continue to get more insurance coverage. I don't think that J-Code will necessarily affect that, give people more confidence around reimbursement, but the increased insurance coverage and confidence around insurance coverage should help as we smooth out the process. And so over time, that number should come down.

當然。是的。謝謝你的提問。我認為正如我們過去所說，腳本進入中心和實際注入之間存在時間滯後。我相信我們所說的是即使是進入市場 5 年的 Ocrevus，它們的平均使用時間約為 6 週。我們繼續關注我們的時間框架，它就在這個範圍內。希望隨著時間的推移，隨著我們繼續獲得更多的保險覆蓋範圍，我們會壓縮。我認為 J 代碼不一定會影響這一點，讓人們對報銷更有信心，但增加的保險範圍和對保險範圍的信心應該有助於我們順利完成這一過程。隨著時間的推移，這個數字應該會下降。

Thanks Adam. And secondly, if the subcutaneous Ocrevus safety already looks good. Do you have any plans for a subcutaneous formulation for Briumvi?

謝謝亞當。其次，如果皮下注射 Ocrevus 的安全性看起來已經很好了。你們有針對 Briumvi 皮下注射製劑的計劃嗎？

Yes. So we've said on multiple calls that we are evaluating the physical biological properties of our material around a subcu and to understand what is feasible with Briumvi in the subcu. So that is -- that work is ongoing as we speak and we're going to make a determination at some point towards the end of the year, early next year or what we might do with that, assuming we have a profile that we think makes sense. But I think to the Ocrevus subcu point, I don't know that we've seen all the safety and tolerability data, I think it would be premature to say that it looks good. I think we haven't seen that data and we're looking forward to seeing it. I assume you will see that at ECTRIMS. So I think the jury is still out on what's the exact profile of the Ocrevus subcu and what that will look like and what the patient experience will be.

是的。因此，我們在多次電話會議中表示，我們正在評估 subcu 周圍材料的物理生物學特性，並了解在 subcu 中使用 Briumvi 的可行性。也就是說，就在我們發言的時候，這項工作正在進行中，我們將在今年年底、明年初的某個時候做出決定，或者假設我們有一個我們認為的概況，我們可能會對此做什麼說得通。但我認為就 Ocrevus subcu 而言，我不知道我們是否已經看到了所有的安全性和耐受性數據，我認為現在說它看起來不錯還為時過早。我認為我們還沒有看到這些數據，但我們期待看到它。我想您會在 ECTRIMS 上看到這一點。因此，我認為對於 Ocrevus subcu 的確切特徵、它的外觀以及患者的體驗如何，目前還沒有定論。

Like I said, anecdotally, we do hear but there's some possibility of pain. And of course, pain is a co-primary endpoint. So it will be interesting to see how that pain endpoint stacks up against placebo. Thank you.

就像我說的，有趣的是，我們確實聽到了，但有可能會感到疼痛。當然，疼痛是一個共同的主要終點。因此，看看疼痛終點如何與安慰劑相比將會很有趣。謝謝。

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。

Just wanted to follow up a little bit on the ex-U.S. deal. Can you give us a little bit more color on the $500 million plus milestones? What would trigger those and how those could roll out?

只是想跟進一下前美國的情況。交易。您能否為我們介紹一下 5 億美元以上的里程碑？什麼會觸發這些以及這些如何推出？

Yes. Sean, do you want to take a crack at that?

是的。肖恩，你想嘗試一下嗎？

Yes, sure. So as you may expect, they're mostly tied to sales milestones in the U.S. escalating on a tiered basis. Beyond that, not providing a whole lot more detail at this point.

是的，當然。因此，正如您所料，它們主要與美國的銷售里程碑相關，並逐步升級。除此之外，目前沒有提供更多細節。

Okay. And then, Sean, similarly for the royalty tiered royalty up to 30%, how should we think about that? How does that work?

好的。然後，Sean，類似地，對於高達 30% 的特許權使用費分級特許權使用費，我們應該如何考慮？這是如何運作的？

I think sort of in a similar fashion escalating from double digits up to 30% is sort of what we're guiding at the moment.

我認為以類似的方式從兩位數上升到 30% 是我們目前的指導方針。

Okay. Okay. And then, I guess, maybe for Adam, can you give us some more detail on the feedback that you're hearing from the different stakeholders, the payers, the doctors, patients and also infusion centers, current feedback that you're getting with for Briumvi.

好的。好的。然後，我想，也許對於 Adam，您能否向我們提供更多有關您從不同利益相關者、付款人、醫生、患者以及輸液中心聽到的反饋的詳細信息，以及您收到的當前反饋對於布里姆維。

Yes, sure. Thanks for the question, Matt. Yes, from a payer perspective, I think the proof is in the pudding. With 80% coverage now, they're talking with their policies and I think we're in good shape there. Patient feedback has been very positive in terms of the infusion time and ability to get in and out of the center. Infusion centers have been very impressed with the overall tolerability and the efficiency that Briumvi provides. Doctors have given us great feedback in terms of the efficacy of the drug and the 1-hour infusion as being attractive, as I mentioned in my remarks. So I would say across the board, we're getting very positive and consistent feedback.

是的，當然。謝謝你的提問，馬特。是的，從付款人的角度來看，我認為證據就在布丁中。現在覆蓋率達到 80%，他們正在討論他們的政策，我認為我們的狀況良好。就輸注時間和進出中心的能力而言，患者的反饋非常積極。 Briumvi 提供的整體耐受性和效率給輸液中心留下了深刻的印象。正如我在發言中提到的，醫生對藥物的功效和 1 小時輸液的吸引力給予了我們很好的反饋。所以我想說的是，我們得到了非常積極和一致的反饋。

Congrats on the ex-U.S. deal.

恭喜前美國交易。

We have reached the end of our question-and-answer session. And with that, I would like to turn the floor back over to CEO, Mike Weiss for closing comments.

我們的問答環節已經結束。說到這裡，我想把發言權交還給首席執行官邁克·韋斯 (Mike Weiss) 發表結束評論。

Great. So on behalf of all the senior management team on this call today. I want to thank all of our shareholders for their continued support and to the entire TG team for their tireless efforts in support of the MS community. As we've mentioned a few times today, we do believe that Briumvi has set a high bar for activity and convenience in the treatment of MS, with the goal of permitting folks with MS to live their best lives. It's really what we're here for, and we work toward it every day. And I know everyone of the company feels the same way. So with that, we are looking forward to a great and exciting second half. And thanks again for joining us, and have a great day.

偉大的。今天我代表所有高級管理團隊參加這次電話會議。我要感謝所有股東的持續支持，並感謝整個 TG 團隊為支持 MS 社區所做的不懈努力。正如我們今天多次提到的，我們確實相信 Briumvi 為多發性硬化症治療的活動性和便利性設定了很高的標準，目標是讓多發性硬化症患者過上最好的生活。這確實是我們存在的目的，並且我們每天都在為此努力。我知道公司的每個人都有同樣的感覺。因此，我們期待著一個偉大而令人興奮的下半場。再次感謝您加入我們，祝您有美好的一天。

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

謝謝。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。