Biogen Inc (BIIB) 2024 Q2 法說會逐字稿

Good morning.

早安.

My name is Anna, and I will be your conference operator today.

我叫安娜，今天我將擔任你們的會議操作員。

At this time, I would like to welcome everyone to the Biogen second quarter 2024 earnings call and business.

此時此刻，我謹歡迎大家參加百健 (Biogen) 2024 年第二季財報電話會議和業務。

(Operator Instructions) Today's conference is being recorded.

（操作員指示）今天的會議正在錄音。

Thank you.

謝謝。

I would now like to turn the conference over to Mr. Chuck Triano, Head of Investor Relations.

現在我想將會議交給投資者關係主管查克·特里亞諾 (Chuck Triano) 先生。

Mr. Triano, you may begin your conference.

特里亞諾先生，您可以開始會議了。

Thank you.

謝謝。

Good morning, good afternoon and welcome to Biogen's second quarter 2024 earnings call.

早安，下午好，歡迎參加百健 (Biogen) 2024 年第二季財報電話會議。

During this call, we'll make forward-looking statements, which involve risks and uncertainties that may cause actual results to differ materially from those in our forward-looking statements.

在本次電話會議中，我們將做出前瞻性聲明，其中涉及風險和不確定性，可能導致實際結果與我們的前瞻性聲明中的結果有重大差異。

We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review.

我們在向 SEC 提交的文件中提供了完整的風險因素列表，我鼓勵您查看。

Our earnings release and other documents related to our results as well as the reconciliation between GAAP and non-GAAP results discussed on the call can be found in the Investors section at biogen.com. We have also posted the slides on our website that will be used during this call.

我們的收益發布和與我們的業績相關的其他文件，以及電話會議上討論的 GAAP 和非 GAAP 業績之間的對賬，可以在 biogen.com 的投資者部分找到。我們也在我們的網站上發布了本次電話會議期間將使用的幻燈片。

On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; our Head and President of North America, Alisha Alaimo; Dr. Priya Singhal, Head of Development; Mike McDonnell, Chief Financial Officer, and we'll be introducing Dr. Travis Murdoch from HI-Bio on the call.

我們的總裁兼執行長 Chris Viehbacher 也參加了今天的電話會議。我們的北美地區負責人兼總裁 Alisha Alaimo； Priya Singhal 博士，開發主管；財務長 Mike McDonnell，我們將在電話會議上介紹來自 HI-Bio 的 Travis Murdoch 博士。

We'll make some opening comments and then we'll move to the Q&A session.

我們將發表一些開場評論，然後進入問答環節。

And to allow us to get through as many questions as possible, we ask that you limit yourself to one question.

為了讓我們能夠回答盡可能多的問題，我們要求您只回答一個問題。

With that, I'll now turn the call over to Chris.

這樣，我現在將把電話轉給克里斯。

Thanks, Chuck.

謝謝，查克。

We got a lot to cover this morning, but first, in addition to our regular team of Priya, Alisha, and Mike, I'd like to welcome a new member to our team, Dr. Travis Murdoch.

今天早上我們有很多內容要討論，但首先，除了我們的常規團隊Priya、Alisha 和Mike 之外，我還想歡迎一位新成員加入我們的團隊，特拉維斯·默多克(Travis Murdoch)博士。

Travis is a physician who trained as a gastroenterologist and then studied immunology as a Rhodes Scholar at Oxford.

特拉維斯（Travis）是一名醫生，接受過胃腸病學家培訓，然後以羅德學者的身份在牛津大學學習免疫學。

Following a career at McKinsey, Third Rock, and Softbank, he became the founder and CEO of HI-Bio.

在麥肯錫、Third Rock 和軟銀工作過之後，他成為 HI-Bio 的創始人兼執行長。

I'm pleased to welcome Travis and the HI-Bio team to Biogen.

我很高興歡迎 Travis 和 HI-Bio 團隊來到百健 (Biogen)。

We now have, again, a presence on the West Coast.

我們現在再次在西海岸開展業務。

And the HI-Bio team, working in collaboration with their Biogen colleagues on the East Coast will drive forward the development of felzartamab.

HI-Bio 團隊將與東岸的 Biogen 同事合作，推動 felzartamab 的開發。

So we're announcing really strong quarterly results this morning.

因此，我們今天早上宣布了非常強勁的季度業績。

But I would say this is really a quarter that has lasted 18 months.

但我想說，這個季度確實持續了 18 個月。

I think the results we're presenting really reflect the hard work of team Biogen to transform our company 18 months ago, we were a company that had been declining for four years in revenue and profit.

我認為我們呈現的結果確實反映了 Biogen 團隊在 18 個月前為我們公司轉型所做的努力，當時我們是一家營收和利潤連續四年下滑的公司。

And we have been working pretty tirelessly for the last 18 months to really turn that around and create a new future for ourselves.

在過去 18 個月裡，我們一直在不知疲倦地工作，以真正扭轉這一局面，為我們自己創造新的未來。

At the Q4 earnings in February of 2023, we outlined five priorities.

在 2023 年 2 月的第四季財報中，我們概述了五個優先事項。

First one was focus on new launches.

第一個是關注新產品的發布。

Second was to reduce our cost base and align resources with growth opportunities.

其次是降低我們的成本基礎並將資源與成長機會結合。

Third was to focus our investments in R&D on the most promising assets and improve the risk reward profile.

第三是將研發投資集中在最有前景的資產上，並改善風險回報狀況。

Four was to optimize our existing portfolio.

四是優化我們現有的投資組合。

And five was external growth.

五是外部成長。

We've had a few setbacks along the way, but nonetheless, I think the results today really show that Biogen has done what it said it would do.

我們一路走來遇到了一些挫折，但儘管如此，我認為今天的結果確實表明百健（Biogen）已經做到了它所說的那樣。

And that to me has been always important in business.

對我來說，這在商業中一直很重要。

So if I take each one of those, I think if we look at our new product launches, all of the launches are either in line or ahead of expectations.

因此，如果我考慮其中的每一項，我認為如果我們看看我們的新產品發布，所有發布的產品要么符合預期，要么超出預期。

I'm particularly happy to see the very strong results for LEQEMBI, not only in the US, but there's been a very successful launch in Japan.

我特別高興地看到 LEQEMBI 不僅在美國取得了非常強勁的成果，而且在日本也取得了非常成功的推出。

And the early data from China are also extremely promising, and Alisha will talk more about that.

來自中國的早期數據也非常有希望，艾莉莎將更多地談論這一點。

Last year, we set out to reduce our cost base and we are more than on track on delivering on those results and you can see that in the -- not only the reduction in OpEx but the very strong improvement in margins and Mike will talk about that.

去年，我們開始降低成本基礎，而且我們在實現這些成果方面已經走上正軌，您可以看到，不僅營運支出減少了，而且利潤率也有了非常強勁的改善，麥克將談到那。

But one of the things that you don't see in the P&L that I'm particularly proud of is although we've really reduced our cost base and improved our margins, we have invested massively where we need to for growth opportunities, both in LEQEMBI and the other launches.

但你在損益表中看不到的一件事是，儘管我們確實降低了成本基礎並提高了利潤，但我特別自豪的一件事是，我們在需要的地方進行了大量投資，以獲得增長機會，無論是在LEQEMBI 和其他產品發布。

But also on really trying to turbocharge some of the key assets in R&D.

但也真正嘗試增強研發中的一些關鍵資產。

And, Priya will talk more about that, but one of the beneficiaries of that is BIIB080, and another one is litifilimab.

Priya 會更多地談論這一點，但其中的受益者之一是 BIIB080，另一個受益者是 litifilimab。

We also have although we have seen a declining MS portfolio due to increased competition, particularly from biosimilars and from generics.

儘管我們看到由於競爭加劇，尤其是來自生物相似藥和仿製藥的競爭加劇，MS 產品組合正在下降，但我們也看到了這一點。

We still had a number of products where we still had long patent protection.

我們仍有許多產品仍享有長期專利保護。

And one was SPINRAZA.

斯賓拉莎就是其中之一。

And I think we've seen some very good performance.

我認為我們已經看到了一些非常好的表現。

This is a very competitive space.

這是一個競爭非常激烈的空間。

And SPINRAZA has been able to hold its own.

而 SPINRAZA 已經能夠保持自己的地位。

I think when I first joined the company, most people thought we were predicting the decline of that.

我想當我第一次加入公司時，大多數人都認為我們正在預測這種趨勢的衰落。

Today, I would say the bumpiness tends to be in some countries where we only ship every now and then.

今天，我想說的是，在一些我們只是偶爾發貨的國家/地區，坎坷往往是存在的。

I think in Russia, for example, we do one shipment per year.

例如，我認為在俄羅斯，我們每年發貨一次。

So that business has always been a little bit bumpy.

所以生意一直都有點坎坷。

But if you look at market share, I think SPINRAZA has done extremely well.

但如果你看看市場份額，我認為 SPINAZA 做得非常好。

And I'm very pleased to see VUMERITY growing at double digits again now in the US.

我很高興看到 VUMERITY 在美國再次以兩位數成長。

This is the only patent protected product in the oral segment of

這是口腔領域唯一受專利保護的產品

(technical difficulty).

（技術難度）。

We see an awful lot of movement in the injectable part, but the oral segment has stayed pretty much constant and it's a great opportunity and I'm glad to see Alisha and her team really taking advantage of that.

我們看到注射部分有很多運動，但口腔部分幾乎保持不變，這是一個很好的機會，我很高興看到 Alisha 和她的團隊真正利用了這一點。

And then, we always said we were going to be open to external growth.

然後，我們總是說我們將對外部成長持開放態度。

And I think the Reata transaction last year is really starting to pay dividends.

我認為去年的 Reata 交易確實開始帶來紅利。

We're seeing a very strong launch not only in the US, but now also in Europe.

我們不僅在美國看到了非常強勁的推出，現在在歐洲也是如此。

As you know, we tend to get patients on access programs and then the reimbursement follows.

如您所知，我們傾向於讓患者參與准入計劃，然後進行報銷。

But we are expecting to be approved in 20 countries by the end of this year.

但我們預計到今年年底將在 20 個國家獲得批准。

And I think we're extremely happy with that.

我認為我們對此非常滿意。

ZURZUVAE addresses a huge unmet need and that launch is also well in excess of expectations.

ZURZUVAE 解決了巨大的未滿足需求，而且該產品的推出也遠遠超出了預期。

So as I sit here today, I would say, the results that you're seeing are not, as I say, just the results of what we've done in the second quarter, but really, I think we're putting up scores on the scoreboard here that really now are starting to demonstrate all of those initiatives that we put in place last year and we're starting to deliver on them.

因此，當我今天坐在這裡時，我想說，你們看到的結果並不像我說的那樣，只是我們在第二季度所做的事情的結果，但實際上，我認為我們正在打分在這裡的記分板上，現在確實開始展示我們去年實施的所有這些舉措，並且我們正在開始實施它們。

Now of course we're not done yet and I think there's a real opportunity to continue to develop a sustainable growth platform.

當然，現在我們還沒有完成，我認為這是一個繼續開發永續成長平台的真正機會。

And we'll do that in two ways.

我們將透過兩種方式做到這一點。

The first is really, now that we have prioritized R&D, I see the Alzheimer's portfolio as being a core franchise for the coming years.

第一個是，現在我們已經優先考慮研發，我認為阿茲海默症產品組合將成為未來幾年的核心業務。

We're obviously continuing to invest heavily in LEQEMBI with the maintenance indication, the subcutaneous, but also I think the AHEAD study, if we can really get the evidence that it will really demonstrate the importance of early treatment.

顯然，我們將繼續在 LEQEMBI 的維持適應症、皮下注射方面進行大量投資，而且我認為 AHEAD 研究，如果我們能夠真正獲得證據，它將真正證明早期治療的重要性。

Priya will talk about it, but the 36 month data that we showed at AAIC this week are extremely important for the future growth of LEQEMBI.

Priya 會談論這個問題，但我們本週在 AAIC 上展示的 36 個月數據對於 LEQEMBI 的未來成長極為重要。

But we've always known there will be other modalities, and I think [Tau] is emerging as an extremely important modality for the treatment of Alzheimer's, and I think Biogen is a clear leader in that.

但我們一直都知道還會有其他治療方式，我認為 Tau 正在成為治療阿茲海默症的一種極其重要的方式，我認為百健（Biogen）是這方面明顯的領導者。

And again, Priya will say more about that.

Priya 會再次對此進行更多闡述。

We're also seeing an emerging lupus portfolio.

我們也看到了一個新興的狼瘡投資組合。

We'll have a readout later this year with [dapirolizumab] that we share with UCB.

我們將在今年稍後與 UCB 分享 [dapirolizumab] 的讀數。

But we're quite excited about litifilimab, both for SLE as well as cutaneous lupus.

但我們對 litifilimab 感到非常興奮，無論是用於治療 SLE 還是皮膚狼瘡。

And we add another element to the lupus portfolio with felza because that is actually in Phase 1 for lupus nephritis.

我們在狼瘡產品組合中添加了另一個元素 felza，因為它實際上處於狼瘡腎炎的第一階段。

And to me, and Travis will go into this more, but the acquisition of HI-Bio is extremely important for our longer term growth outlook.

對我和 Travis 來說，收購 HI-Bio 對我們的長期成長前景極為重要。

This is an opportunity to present a set of opportunities that have a different risk-benefit profile.

這是一個展示一系列具有不同風險收益特徵的機會的機會。

We have very strong Phase 2 results, which gives us a whole lot more confidence in Phase 3 results than some of the other assets that we have in our portfolio.

我們第二階段的結果非常強勁，這讓我們對第三階段的結果比我們投資組合中的其他一些資​​產更有信心。

Neuroscience is an area of a very important unmet need, but it's also one of the riskiest and hardest areas.

神經科學是一個非常重要的未滿足需求的領域，但它也是風險最大、最困難的領域之一。

And so I think we get a little bit more balance in our portfolio by pursuing things in immunology.

因此，我認為透過追求免疫學，我們的投資組合會更加平衡。

And so I personally am extremely excited about felza and what Travis and his team can do.

因此，我個人對 felza 以及 Travis 和他的團隊可以做的事情感到非常興奮。

The other axis to this is we're going to continue to look at business development.

另一個軸是我們將繼續專注於業務發展。

I think you have seen that we're pretty disciplined.

我想你已經看到我們非常有紀律。

I think both of the acquisitions that we've done so far with Reata and HI-Bio will drive an awful lot of shareholder value and that is certainly top of mind as we look at business development.

我認為我們迄今為止對 Reata 和 HI-Bio 進行的兩次收購都將帶來巨大的股東價值，這在我們考慮業務發展時無疑是首要考慮的。

So I think Biogen is in a much different place than we were 18 months ago.

所以我認為百健 (Biogen) 的處境與 18 個月前有很大不同。

We still have a number of challenges like any other company, but I think we're really positioned for longer-term growth now at the company.

與其他公司一樣，我們仍然面臨著許多挑戰，但我認為我們現在確實已經為公司的長期成長做好了準備。

And with that, I'd like to turn it over to Alisha to give us a little more color on the successful launches.

說到這裡，我想把它交給 Alisha，讓我們對成功的發布有更多的了解。

Thank you, Chris, and good morning, everyone.

謝謝你，克里斯，大家早安。

Thank you for joining the call today.

感謝您今天加入通話。

Today I'll provide our perspective on the progress with LEQEMBI, SKYCLARYS and ZURZUVAE.

今天，我將提供我們對 LEQEMBI、SKYCLARYS 和 ZURZUVAE 進展的看法。

So I will begin with the Alzheimer's market.

所以我將從阿茲海默症市場開始。

We believe we're continuing to build momentum with more health systems across the country, now having the capability to treat a higher volume of Alzheimer's patients.

我們相信，我們將繼續在全國範圍內建立更多的衛生系統，現在有能力治療更多的阿茲海默症患者。

And in Q2, we saw these promising trends continue.

在第二季度，我們看到這些有希望的趨勢仍在繼續。

Notably, we sustained new patient growth.

值得注意的是，我們維持了新患者的成長。

Nearly 40% of all commercial patients on therapy since launch, started treatment during Q2.

自推出以來接受治療的所有商業患者中有近 40% 在第二季開始接受治療。

The number of physicians prescribing LEQEMBI also grew by 50%.

開立 LEQEMBI 處方的醫生數量也增加了 50%。

Depth of ordering at our priority 100 IDNs continued to accelerate, and the total order volume more than doubled again in Q2 compared to Q1.

我們優先 100 個 IDN 的訂購深度繼續加快，第二季度的總訂單量與第一季相比再次增加了一倍多。

It's important to know that based on the data we've seen to date, these trends continued into the first weeks of July, demonstrating that we are sustaining launch progress.

重要的是要知道，根據我們迄今為止看到的數據，這些趨勢一直持續到 7 月的前幾週，這表明我們正在維持發布進度。

We also believe we're seeing positive signals that health system capacity may be increasing.

我們也相信，我們看到了衛生系統能力可能正在增強的正面訊號。

For example, last quarter, I described how some IDNs are expanding and extending their sites of care.

例如，上個季度，我描述了一些 IDN 如何擴展和擴展其護理站點。

Through Q2, nearly 70% of the activated priority 100 IDNs expanded beyond their flagship sites to treat patients at their trial sites.

截至第二季度，已啟動的優先 100 個 IDN 中近 70% 擴展到其旗艦站點之外，在其試驗站點治療患者。

And we have seen this dynamic play out beyond the priority IDNs as well.

我們也看到這種動態也超出了優先 IDN 的範圍。

We believe this growing real world experience with LEQEMBI efficacy and safety further strengthens its unique profile in a newly competitive market.

我們相信，LEQEMBI 功效和安全性的真實世界經驗不斷增長，進一步增強了其在新競爭市場中的獨特形象。

Specifically, some HCP share that because LEQEMBI was studied in the broadest and most diverse population of any anti-amyloid drug today, it removed some of the complex considerations about which potential patients are appropriate for Alzheimer's treatments.

具體來說，一些HCP 認為，由於LEQEMBI 是在當今所有抗澱粉樣蛋白藥物中最廣泛和最多樣化的人群中進行研究的，因此它消除了關於哪些潛在患者適合阿茲海默症治療的一些複雜考慮。

Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed.

阿茲海默症是一種慢性、退化性、致命性疾病，即使斑塊被去除後也不會停止。

In fact, our long-term data show that patients who stopped LEQEMBI treatment experienced rapid re-accumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning.

事實上，我們的長期數據顯示，停止 LEQEMBI 治療的患者經歷了關鍵血漿生物標記的快速重新積累，這表明阿茲海默症生物學正在回歸。

Importantly the rate of decline in most patients who stopped therapy were averted to the rate of decline observed in patients who took placebo.

重要的是，大多數停止治療的患者的下降率與服用安慰劑的患者中觀察到的下降率相反。

Which is why we believe patients deserve a therapy with a benefit risk profile that enables them to remain on treatment to stay ahead of disease progression, even after removing plaques by preventing ongoing damage and plaque buildup.

這就是為什麼我們認為患者應該接受具有獲益風險概況的治療，使他們能夠繼續接受治療，以領先於疾病進展，即使在通過防止持續損傷和斑塊積聚去除斑塊後也是如此。

Recent data that Priya will describe reinforces that in patients with three years of continuous treatment, LEQEMBI showed continued benefits.

Priya 將描述的最新數據證實，在連續治療三年的患者中，LEQEMBI 顯示出持續的益處。

And finally, though there are no head-to-head studies comparing the available therapies, the FDA has been clear that the incidence and timing of ARIA vary among drugs in this class.

最後，儘管沒有比較現有療法的頭對頭研究，但 FDA 已明確表示，此類藥物中 ARIA 的發生率和發生時間各不相同。

Observed ARIA rates in patients who receive LEQEMBI were the lowest reported among any Phase 3 trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower.

在接受 LEQEMBI 治療的患者中觀察到的 ARIA 率是 FDA 傳統批准的同類藥物的所有 3 期試驗中報告的最低值，LEQEMBI 率低近 50%。

To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month.

為了加強 LEQEMBI 在我們客戶中的獨特形象，百健 (Biogen) 上個月剛剛部署了我們擴大的現場人員。

This team increases our focus and frequency, engaging with high-value sites, and expands our reach to 30% more HCPs.

團隊提高了我們對高價值網站的關注度和頻率，並將我們的覆蓋範圍擴大到了 30% 以上的 HCP。

We've been receiving positive feedback since the launch of this team.

自從團隊成立以來，我們一直收到正面的回饋。

Biogen's field force is working even more closely with our partner Eisai, and we believe this is deepening our customer insights and we will enable accelerated growth.

百健 (Biogen) 的現場團隊正在與我們的合作夥伴衛材 (Eisai) 更加密切地合作，我們相信這正在加深我們的客戶洞察力，我們將實現加速成長。

We're encouraged by two strong quarters of growth and the sustained progress in July, and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease.

我們對兩個季度的強勁成長和 7 月的持續進展感到鼓舞，我們期待為醫療保健界和阿茲海默症患者提供更多支持。

Now, moving on to the SKYCLARYS update, where we continue our strong launch momentum reaching more Friedreich's ataxia patients globally.

現在，我們將繼續進行 SKYCLARYS 更新，我們將繼續保持強勁的發布勢頭，覆蓋全球更多的弗里德賴希共濟失調患者。

In the second quarter, we delivered $100 million in revenue globally and remain ahead of our internal expectations.

第二季度，我們在全球實現了 1 億美元的收入，仍然領先於我們的內部預期。

Europe launch is ahead of internal forecast and along with rest of world builds on the success in the US.

歐洲的推出時間早於內部預測，並且與世界其他地區一起在美國取得成功。

SKYCLARYS is now available in 12 markets outside the US including the EU where we are initiating new patients in the catch-up population.

SKYCLARYS 現已在美國以外的 12 個市場上市，其中包括歐盟，我們正在該地區的追趕人群中啟動新患者。

These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval, as is typical for rare disease launches.

這些患者及其 HCP 高度參與護理，並經常等待 SKYCLARYS 批准，這對於罕見疾病的上市來說是典型的情況。

In the US, we have moved beyond the catch-up population as SKYCLARYS has been in market for more than a year.

在美國，隨著 SKYCLARYS 上市一年多，我們已經超越了追趕人群。

The team continues to leverage our strong rare disease capabilities and we are encouraged by the early results of engaging patients and physicians in this next phase.

團隊繼續利用我們強大的罕見疾病治療能力，我們對下一階段患者和醫生參與的早期結果感到鼓舞。

In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program, which analyzes hundreds of thousands of de-identified patient journeys.

在第二季度，大約三分之一的新患者起始表格來自與我們的人工智慧程式相關的新作者，該程式分析了數十萬未識別的患者旅程。

This includes a meaningful share from community neurologists and PCPs.

這包括社區神經科醫生和 PCP 的有意義的分享。

Globally, our outlook in [FA] is promising in both the short and long term.

在全球範圍內，我們對[FA]的前景無論是短期還是長期都是充滿希望的。

We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations, and with our years of experience identifying patients, we believe we can help.

我們預計透過在更多地區提供 SKYCLARYS、潛在擴展到兒科人群來推動強勁增長，並且憑藉我們多年識別患者的經驗，我們相信我們可以提供幫助。

Turning to ZURZUVAE, we continue to outperform our expectations in the first six months of launch.

至於 ZURZUVAE，我們在推出的前六個月繼續超出了我們的預期。

We saw strong growth in the second quarter with US revenue growing 19% and patient demand nearly doubling versus the first quarter.

我們在第二季度看到了強勁的成長，美國營收成長了 19%，患者需求比第一季幾乎翻了一番。

OB-GYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms.

婦產科醫生繼續主導處方，患者正在與醫生和社交媒體平台分享積極的早期經驗。

Based on our recent market research, we believe we've achieved higher than average aided awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets.

根據我們最近的市場研究，我們相信我們在提供者中對 ZURZUVAE 的輔助認知高於平均水平，在女性健康和精神病學市場上的表現優於訊息召回類似產品。

To achieve the next phase of growth and advance our vision to transform the care of postpartum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change.

為了實現下一階段的成長並推進我們改變產後憂鬱症護理的願景，我們正在努力更深入地了解如何在這個市場中實現患者的機會並推動真正的行為改變。

In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies.

總而言之，雖然每次推出都是獨一無二的，但我們很高興我們在所有三種療法中都保持在正軌或領先於我們的預期。

We know we have more work to do to help people living with Alzheimer's, Friedrich's ataxia, and postpartum depression, and we are working with urgency to help these patient communities.

我們知道，我們還有更多工作要做，可以幫助阿茲海默症、弗里德里希共濟失調和產後憂鬱症患者，我們正在緊急努力幫助這些患者社區。

I will now pass to Priya.

我現在請普里亞發言。

Thank you, Alisha.

謝謝你，艾莉莎。

Over the last year, we have focused heavily on reviewing our existing pipeline with an eye toward improving its risk profile.

去年，我們專注於審查現有管道，並著眼於改善其風險狀況。

The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value.

現在的重點是透過內部和外部機會的結合來建立管道，著眼於風險分散和創造價值。

We also remain focused on investing to win in Alzheimer's disease, where we believe we have a differentiated product in LEQEMBI, as well as an industry-leading R&D pipeline of potential next-generation therapies.

我們也繼續專注於投資以贏得阿茲海默症的勝利，我們相信我們在 LEQEMBI 方面擁有差異化產品，以及業界領先的潛在下一代療法的研發管線。

Beginning with LEQEMBI.

從 LEQEMBI 開始。

LEQEMBI is the only approved anti-amyloid antibody with.

LEQEMBI 是唯一核准的抗澱粉樣蛋白抗體。

First, a dual mechanism of action targeting both amyloid plaques and highly toxic protofibrils.

首先，針對澱粉樣斑塊和高毒性原纖維的雙重作用機轉。

Second, clinical data across the full early Alzheimer's disease population, including individuals with no and low Tau.

其次，整個早期阿茲海默症族群的臨床數據，包括沒有 Tau 蛋白和 Tau 蛋白水平較低的個體。

And third, extensive real-world evidence.

第三，廣泛的現實世界證據。

Importantly, as Alicia mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continued treatment is a unique advantage for patients looking to maintain or further clinical benefit.

重要的是，正如Alicia 所提到的，阿茲海默症是一種慢性進行性疾病，我們相信LEQEMBI 的雙重作用和持續治療的選擇對於尋求維持或進一步臨床獲益的患者來說是一個獨特的優勢。

To this point, at AAIC earlier this week, Eisai presented three-year data from the Phase 3 Clarity study and its open-label extension, which shows continued clinical benefit with longer duration LEQEMBI treatment.

到目前為止，衛材在本週早些時候的 AAIC 上展示了 3 期 Clarity 研究及其開放標籤擴展的三年數據，該數據顯示了更長持續時間的 LEQEMBI 治療的持續臨床益處。

Shown on the left, this includes data from the early start group or individuals who started LEQEMBI during the 18 month placebo-controlled portion of the study, delayed start group or patients from the placebo arm who switched over to LEQEMBI at the start of the open label extension, as well as a baseline matched natural history cohort from ADNI.

如左圖所示，這包括早期開始組或在研究的 18 個月安慰劑對照部分開始 LEQEMBI 的個體、延遲開始組或在開放開始時轉為 LEQEMBI 的安慰劑組患者的數據標籤擴展，以及來自ADNI 的基線匹配自然歷史隊列。

The early start group shows that three years of continuous leukemia treatment reduced clinical decline by negative 0.95 on CDR sum of boxes as compared to the natural history cohort.

早期開始組顯示，與自然史隊列相比，連續三年的白血病治療使 CDR 盒總和的臨床衰退減少了負 0.95。

Resulting in a clinically meaningful benefit for early AD patients.

為早期 AD 患者帶來具有臨床意義的益處。

This represents an expansion of the benefit observed at 18 months.

這代表 18 個月時觀察到的益處有所擴大。

It is very important to keep in mind that a change from 0.5 to 1 on the CDR score domains of memory, community affairs, home and hobbies is the difference between slight impairment and loss of independence.

重要的是要記住，記憶、社區事務、家庭和愛好領域的 CDR 評分從 0.5 到 1 的變化是輕微損傷和喪失獨立性之間的區別。

We believe these results are significant as the majority of individuals, approximately 70%, had already successfully cleared plaque by the 18 month time point.

我們相信這些結果意義重大，因為大多數人（約 70%）在 18 個月的時間點已經成功清除了牙菌斑。

Furthermore, data from the Lecanemab Phase 2 study, shown on the right, which included a treatment gap of approximately two years on average, shows that Alzheimer's disease continues to progress when treatment is stopped or interrupted even after plaques are removed.

此外，右側顯示的 Lecanemab 2 期研究的數據（其中包括平均約兩年的治療間隙）表明，即使在斑塊去除後，當治療停止或中斷時，阿茲海默症仍在繼續進展。

Also at AAIC, Eisai presented data which showed that 51% of patients in the Clarity AD study with either no or low tau representing an early stage of Alzheimer's showed improvement from baseline in cognition and function over a three-year period as assessed by CDR sum of boxes.

同樣在AAIC 上，衛材發表的數據顯示，在Clarity AD 研究中，51% 的tau 蛋白缺失或水平較低（代表阿茲海默症早期階段）的患者在三年期間的認知和功能較基線有所改善（根據CDR 總和評估）的盒子。

Taken together, these data suggest that earlier initiation of treatment with lecanemab may have a significant positive impact on disease progression and may provide continued benefits to patients with early Alzheimer's disease over the long-term.

總而言之，這些數據表明，早期開始 Lecanemab 治療可能對疾病進展產生顯著的正面影響，並可能為早期阿茲海默症患者提供長期持續的益處。

We continue to focus our efforts on LEQEMBI with a goal of characterizing dosing for its long-term benefit, providing optionality with subcutaneous formulation, as well as evaluating its role in preclinical AD population, as Chris mentioned.

正如 Chris 所提到的，我們繼續將精力集中在 LEQEMBI 上，目標是確定其長期益處的給藥劑量、提供皮下製劑的選擇性，以及評估其在臨床前 AD 族群中的作用。

Lastly, while we were disappointed to learn that Lecanemab received a negative opinion from the CHMP, we believe that the clinical data supports a clear favorable benefit risk profile with a meaningful clinical benefit to patients.

最後，雖然我們很失望地得知 Lecanemab 收到了 CHMP 的負面意見，但我們相信臨床數據支持明確有利的獲益風險概況，對患者俱有有意義的臨床益處。

Furthermore, thousands of patients have now been treated with Lecanemab globally, providing further real-world evidence on the efficacy and manageable safety profile.

此外，全球已有數千名患者接受 Lecanemab 治療，這為有效性和可控安全性提供了進一步的現實證據。

We are continuing to work with Eisai as they plan to request a re-examination of the EU filing as we work to enable access for people suffering from Alzheimer's globally.

我們將繼續與衛材合作，他們計劃要求重新審查歐盟的申請，同時我們努力為全球阿茲海默症患者提供使用機會。

We continue to also invest in our broader Alzheimer's pipeline, including our investigational anti-tau ASO BIIB080.

我們也持續投資於更廣泛的阿茲海默症產品線，包括我們正在研究的抗 tau 蛋白 ASO BIIB080。

Based on the encouraging data from the Phase 1b study, we have now implemented a protocol amendment for the ongoing Phase 2 CELIA study with the aim of accelerating a potential proof-of-concept outcome.

基於 1b 期研究令人鼓舞的數據，我們現已對正在進行的 2 期 CELIA 研究實施了方案修訂，旨在加速潛在的概念驗證結果。

We are excited that this amendment, combined with the robust enrollment trends observed to date, may enable a readout in 2026.

我們很高興這項修正案，加上迄今為止觀察到的強勁入學趨勢，可能會在 2026 年公佈。

Beyond amyloid and tau and under Jane's guidance in research, we are advancing a preclinical AD pipeline that encompasses diverse targets and modalities, including active transport approaches.

除了澱粉樣蛋白和 tau 蛋白外，在 Jane 的研究指導下，我們正在推進臨床前 AD 管道，其中包括不同的目標和模式，包括主動轉運方法。

As communicated today in our earnings release, we decided to exit the ATV:Abeta collaboration with Denali.

正如我們今天在財報中所傳達的，我們決定退出 ATV:Abeta 與 Denali 的合作。

We continue to see merit in modalities that can actively transport therapeutic agents into the brain.

我們繼續看到能夠主動將治療劑輸送到大腦中的方式的優點。

And we continue to prioritize these efforts as we work to build upon our existing leadership in AD.

在努力鞏固我們在廣告領域現有領導地位的同時，我們將繼續優先考慮這些努力。

Looking back over the last few months, while we discontinued three mid-stage programs based on readouts, we continued to make progress across several other areas of our pipeline.

回顧過去幾個月，雖然我們停止了三個基於讀數的中期計劃，但我們繼續在管道的其他幾個領域取得進展。

The first patient has received a dose of SKYCLARYS in Biogen's Phase 1 dose finding study for pediatric Friedreich's Ataxia.

在百健（Biogen）針對兒科弗里德賴希共濟失調的 1 期劑量探索研究中，第一位患者接受了 SKYCLARYS 劑量。

This is the first step in potentially expanding SKYCLARYS access to the pediatric population.

這是擴大 SKYCLARYS 接觸兒科族群的第一步。

And once a dose is identified, we plan to conduct a Phase 3 study to assess the benefit/risk in pediatric patients.

一旦確定劑量，我們計劃進行第三階段研究，以評估兒科患者的益處/風險。

We also expect the DEVOTE study evaluating high dose SPINRAZA to readout in this second half of the year.

我們也預計評估高劑量 SPINRAZA 的 DEVOTE 研究將在今年下半年公佈。

We have also made meaningful progress in immunology where the first patient was dosed in the litifilimab Phase 3 portion of the operationally seamless Phase 2,3 Amethyst study in CLE following the completion of the Phase 2 enrollment.

我們在免疫學方面也取得了有意義的進展，在完成 2 期入組後，第一位患者在 CLE 無縫 2,3 期 Amethyst 研究的 litifilimab 3 期部分中接受了給藥。

As Chris mentioned, we continue to view immunology as a significant potential driver of Biogen's future growth and the recent acquisition of HI-Bio is an example of this importance.

正如 Chris 所提到的，我們繼續將免疫學視為 Biogen 未來成長的重要潛在驅動力，最近收購 HI-Bio 就是這一重要性的一個例子。

With that, I would like to hand over the call to Travis, who will dive a bit deeper into felzartamab.

至此，我想將電話轉交給 Travis，他將更深入地研究 felzartamab。

Thank you, Priya.

謝謝你，普里亞。

I'm very excited to be here speaking today as part of the Biogen team.

我很高興今天能作為百健團隊的一員在這裡發言。

I believe we have a unique opportunity to combine HI-Bio's expertise in immune mediated indications with Biogen's global development and commercial experience in specialized immunology and rare diseases.

我相信我們有一個獨特的機會將 HI-Bio 在免疫介導適應症方面的專業知識與 Biogen 在專業免疫學和罕見疾病方面的全球發展和商業經驗相結合。

I believe this synergy will have significant benefit as we work to accelerate our lead asset, felzartamab, or felza, into late stage development.

我相信，當我們努力加速我們的主導資產 felzartamab 或 felza 進入後期開發時，這種協同效應將帶來顯著的好處。

As an anti-CD38 antibody, we believe felzartamab has a differentiated molecular design that specifically targets and depletes plasma cells responsible for producing pathogenic antibodies, while sparing the broader B-cell lineage.

作為一種抗 CD38 抗體，我們相信 felzartamab 具有差異化的分子設計，可以特異性靶向並消耗負責產生致病性抗體的漿細胞，同時保留更廣泛的 B 細胞譜系。

This is different from other programs currently in development for antibody mediated diseases that more broadly impact B cells.

這與目前正在開發的針對抗體介導疾病的其他項目不同，這些疾病更廣泛地影響 B 細胞。

Compared to other mechanisms, we believe the specificity of [felza's MoA] may allow for a differentiated and more desirable clinical profile characterized by more durable efficacy and improved safety profile.

與其他機制相比，我們相信 [felza 的 MoA] 的特異性可能會帶來差異化且更理想的臨床特徵，其特徵是更持久的療效和更高的安全性。

As Chris mentioned, one of Biogen's goals is to optimize the risk reward of the pipeline and I believe the acquisition of felza significantly advances that effort.

正如克里斯所提到的，百健（Biogen）的目標之一是優化管道的風險回報，我相信收購 felza 顯著推進了這項努力。

Through its cell depletion approach, felza has already demonstrated clinical proof of concept across multiple rare immunology indications.

透過其細胞耗竭方法，felza 已經證明了多種罕見免疫學適應症的臨床概念證明。

Antibody mediated rejection, AMR, IgA -- nephropathy, IgAN, and primary membranous nephropathy, or PMN, are serious conditions that lead to severe consequences for patients such as transplant failure or end stage kidney disease and available treatment options leave significant unmet need.

抗體介導的排斥反應、AMR、IgA 腎病變、IgAN 和原發性膜性腎病變(PMN) 都是嚴重疾病，會對患者造成嚴重後果，例如移植失敗或末期腎病，而現有的治療方案仍有大量未滿足的需求。

And so, we see significant potential commercial opportunity here.

因此，我們在這裡看到了巨大的潛在商業機會。

Now I'd like to briefly review the felza data generated to date across these indications to highlight the potential value we see for patients.

現在，我想簡要回顧迄今為止針對這些適應症產生的 felza 數據，以強調我們為患者看到的潛在價值。

AMR is the leading cause of kidney transplant loss in the US, with no approved treatments and prior investigational agents have not demonstrated significant resolution of AMR on biopsy.

在美國，AMR 是導致腎臟移植失敗的主要原因，目前尚無批准的治療方法，而且先前的研究藥物在活檢時也未顯示出 AMR 的顯著解決。

The consequences here can be dire, ending with graft failure, dialysis, and a need for retransplantation in many cases.

這種情況的後果可能是可怕的，在許多情況下會導致移植失敗、透析和需要重新移植。

In the Phase 2 study, which we published in The New England Journal of Medicine, nine doses of felza IV administered over a five-month period resulted in greater than 80% AMR resolution at week 24 versus 20% for the placebo group.

在我們發表在《新英格蘭醫學雜誌》上的 2 期研究中，在 5 個月內服用 9 劑 felza IV 導致第 24 週時 AMR 緩解率超過 80%，而安慰劑組為 20%。

Furthermore, two-thirds of responders maintained AMR resolution out to 52 weeks.

此外，三分之二的回應者將 AMR 解決方案維持長達 52 週。

So we believe these results, if replicated in a registrational study, are potentially transformative for this disease.

因此，我們相信這些結果如果在註冊研究中複製，可能會改變這種疾病。

Next, I'd like to discuss IgA nephropathy, or IgAN, which is the most prevalent chronic glomerular disease worldwide and another indication where we believe felza has the potential to deliver a treatment option for patients with important differentiation.

接下來，我想討論 IgA 腎病（IgAN），它是全世界最常見的慢性腎小球疾病，也是我們相信 felza 有潛力為具有重要分化的患者提供治療選擇的另一個適應症。

Felza directly depletes CD38 positive plasma cells, the producers of both galactose-deficient-IgA1 and its autoantibody, which are believed to be the most upstream causes of IgAN.

Felza 直接消耗 CD38 陽性漿細胞，這些細胞是缺乏半乳糖的 IgA1 及其自體抗體的產生者，被認為是 IgAN 的最上游原因。

As shown here on the slide, felza treatment resulted in durable reductions in IgA up to 24 months, which is more than 18 months after the last dose.

如幻燈片所示，felza 治療導致 IgA 持續減少長達 24 個月，即距離最後一次給藥後超過 18 個月。

Importantly, this pharmacodynamic effect was selective for IgA, with IgG and IgM levels rebounding to baseline after the completion of the five-month felza treatment.

重要的是，這種藥效作用對 IgA 具有選擇性，在 5 個月的 felza 治療完成後，IgG 和 IgM 水平反彈至基線。

These results, paired with the emerging clinical efficacy data, suggest that felza could have a durable selective effect on IgA and thus impact IgAN disease biology, while potentially allowing for the maintenance of general protective immunity conferred by IgG and IgM antibodies over a prolonged period on therapy.

這些結果與新出現的臨床療效數據相結合，表明 felza 可能對 IgA 具有持久的選擇性作用，從而影響 IgAN 疾病生物學，同時可能允許長期維持 IgG 和 IgM 抗體賦予的一般保護性免疫。

Similar to the effects we saw in IgA, interim results from the Phase 2 IGNAZ study showed a durable reduction in proteinuria as measured by UPCR.

與我們在 IgA 中看到的效果類似，第二階段 IGNAZ 研究的中期結果顯示，透過 UPCR 測量，蛋白尿持續減少。

Specifically, we saw there was a dose dependent reduction in UPCR, durable out to the 24 month time point.

具體來說，我們發現 UPCR 存在劑量依賴性減少，持續到 24 個月的時間點。

Now in terms of potential differentiation, it's important to note that this improvement is after more than 18 months of being off therapy, supporting the potential for felza to be the first non-chronic treatment option in IgAN.

現在就潛在分化而言，值得注意的是，這種改善是在停止治療超過 18 個月後發生的，這支持 felza 成為 IgAN 的第一個非慢性治療選擇的潛力。

Furthermore, in line with the selective targeting of plasma cells, administration of felza was generally well tolerated with the safety profile consistent with prior studies.

此外，根據漿細胞的選擇性靶向，felza 的給藥通常具有良好的耐受性，其安全性與先前的研究一致。

We believe these interim results potentially provide for a wide therapeutic window and may ultimately lower the risk of chronic immunosuppression, which could be a significant benefit for IgAN patients.

我們相信這些中期結果可能提供更寬的治療窗口，並可能最終降低慢性免疫抑制的風險，這可能對 IgAN 患者帶來重大益處。

Moving to PMN.

轉向 PMN。

So this is a severe antibody mediated disease in the kidney that's a leading cause of nephrotic syndrome, which is a severe syndrome resulting from excretion of too much protein in the urine and which causes symptoms such as swelling and fatigue and increased risk of infection.

因此，這是一種嚴重的抗體介導的腎臟疾病，也是腎病綜合徵的主要原因，腎病綜合徵是一種由於尿液中排出過多蛋白質而引起的嚴重綜合徵，會導致腫脹和疲勞等症狀，並增加感染風險。

Current standard of care, which includes immunosuppressive and chemotherapeutic agents, has proven insufficient as up to 40% of patients do not achieve remission and many progress to end stage kidney disease.

目前的護理標準（包括免疫抑制劑和化療藥物）已被證明是不夠的，因為高達 40% 的患者沒有達到緩解，並且許多患者進展為末期腎病。

It's estimated that up to 80% of patients with PMN have auto antibodies against PLA2R, which is a kidney antigen and which provides us with a key biomarker both for patient stratification as well as treatment response.

據估計，高達 80% 的 PMN 患者俱有針對 PLA2R 的自身抗體，PLA2R 是腎臟抗原，為我們提供了患者分層和治療反應的關鍵生物標記。

In the Phase 2 M-PLACE study, which evaluated felza in both newly diagnosed and relapsed patients as well as patients refractory to immunosuppressive therapy, a 24-week felza treatment resulted in rapid, deep and durable reduction in anti-PLA2R antibodies in both patient cohorts at the one-year time point.

在第 2 期 M-PLACE 研究中，對新診斷和復發患者以及免疫抑制治療難治性患者進行了 felza 評估，為期 24 週的 felza 治療導致兩名患者的抗 PLA2R 抗體快速、深度和持久減少一年時間點的隊列。

Many patients retained immunologic complete response more than six months after the last dose of felza, which highlights the durability of felza's treatment effect.

許多患者在最後一次服用 felza 後六個月以上仍保持免疫完全緩解，這凸顯了 felza 治療效果的持久性。

Importantly, the effect on anti-PLA2R was mirrored when examining reductions in proteinuria.

重要的是，在檢查蛋白尿的減少時，也反映了抗 PLA2R 的效果。

And in line with prior studies of felza TEAEs were generally mild or moderate in severity.

與先前 felza 的研究一致，TEAE 的嚴重程度一般為輕度或中度。

Based on these results, we believe that felza has the potential to provide a meaningful new treatment for patients suffering with PMN.

基於這些結果，我們相信 felza 有潛力為患有 PMN 的患者提供一種有意義的新療法。

In summary, we believe the data generated to date highlight the potential for felza to be a best-in-class treatment option across multiple serious immunologic diseases with significant unmet need.

總之，我們相信迄今為止產生的數據突顯了 felza 有可能成為多種嚴重未滿足需求的嚴重免疫性疾病的最佳治療選擇。

Phase 2 data across AMR, IgAN, and PMN have provided proof-of-concept and highlighted a potentially differentiated clinical profile on the basis of efficacy, treatment durability and safety.

AMR、IgAN 和 PMN 的 2 期數據提供了概念驗證，並強調了基於療效、治療持久性和安全性的潛在差異化臨床特徵。

I'm looking forward now to combining the strengths of the joint HI-Bio and Biogen team as we work to incorporate these learnings and further refine our Phase 3 plans.

我現在期待著結合 HI-Bio 和 Biogen 聯合團隊的優勢，努力整合這些經驗教訓並進一步完善我們的第三階段計劃。

Now we expect to initiate Phase 3 studies across AMR, IgAN, and PMN next year, beginning with AMR in the first half of the year.

現在，我們預計明年將啟動 AMR、IgAN 和 PMN 的 3 期研究，從今年上半年的 AMR 開始。

I'd now like to pass the call over to Mike for a financial update.

我現在想將電話轉接給麥克，以了解最新的財務狀況。

Thank you, Travis, and good morning, good afternoon to everyone.

謝謝你，崔維斯，大家早安，下午好。

I'd like to start by acknowledging the entire Biogen team for a strong second quarter.

首先，我要感謝整個百健團隊在第二季的強勁表現。

I'm pleased to provide some color on the results and please note that all the comparisons that I will make are versus the second quarter of 2023.

我很高興對結果進行一些說明，請注意，我將進行的所有比較都是與 2023 年第二季進行的。

Total revenue of $2.5 billion was up marginally versus the prior year at actual currency and grew 1% at constant currency.

總營收為 25 億美元，以實際貨幣計算比上年略有成長，以固定匯率計算成長 1%。

But importantly, we grew our core pharmaceutical revenue 5% at actual currency and 6% at constant currency.

但重要的是，我們的核心藥品收入按實際貨幣計算增長了 5%，以固定匯率計算增長了 6%。

This was driven by the performance of our four recent launches, which more than offset the revenue decline in our MS business.

這是由我們最近推出的四項產品的業績推動的，這足以抵消我們 MS 業務收入的下降。

Non-GAAP diluted EPS grew 31% to $5.28 and included a one-time benefit of $0.52 from the sale of one of our two priority review vouchers.

非 GAAP 攤薄後每股收益成長 31%，達到 5.28 美元，其中包括出售我們的兩張優先審核憑證之一而獲得的 0.52 美元的一次性收益。

Absent the PRV sale, non-GAAP EPS would have grown 18% to $4.76. We also reported a 43% improvement in non-GAAP operating income, which was a 30% improvement excluding the PRV sale.

如果沒有 PRV 出售，非 GAAP 每股盈餘將成長 18% 至 4.76 美元。我們還報告稱，非 GAAP 營業收入成長了 43%，其中不包括 PRV 銷售的收入成長了 30%。

We continue to benefit from our R&D prioritization and fit for growth initiatives, where I'll provide more detail in a moment.

我們繼續受益於我們的研發優先順序並適應成長計劃，我稍後將提供更多詳細資訊。

We are pleased to be raising our full year 2024 guidance range.

我們很高興上調 2024 年全年指引範圍。

And in just a few moments, I will also provide some additional details on our guidance.

稍後，我還將提供有關我們指導的一些其他詳細資訊。

Now a bit more color on our revenue for the second quarter.

現在我們對第二季的收入有更多的了解。

Our MS franchise revenue declined approximately 5% in the quarter, and there are a few dynamics in this business that are worth highlighting.

本季我們的 MS 特許經營收入下降了約 5%，該業務有一些值得強調的動態。

First, we continue to see erosion of our [interferon] business as the entire class is seeing a shift to higher efficacy or oral therapies.

首先，我們繼續看到我們的[幹擾素]業務受到侵蝕，因為整個類別都在轉向更高功效或口服療法。

Regarding TECFIDERA in the EU, we have now seen most generics exit the market, which helped drive ex-US growth of 11% at actual currency and 12% at constant currency to $208 million this quarter.

關於歐盟的 TECFIDERA，我們現在已經看到大多數仿製藥退出市場，這有助於推動本季度除美國地區的實際貨幣增長 11%，按固定貨幣計算增長 12%，達到 2.08 億美元。

We continue to believe that we are entitled to market protection in the EU until February of 2025.

我們仍然相信，我們有權在 2025 年 2 月之前在歐盟獲得市場保護。

VUMERITY had its best quarter since launch as global revenue grew 13% actual and constant currency to $166 million.

VUMERITY 迎來了自推出以來最好的季度，以固定匯率計算，全球營收實際成長 13%，達到 1.66 億美元。

VUMERITY remains the number one branded oral in terms of share in the United States.

就美國市佔率而言，VUMERITY 仍然是第一大口服品牌。

US TYSABRI revenue of $249 million declined 4% and benefited from the timing of shipments in the quarter, which was offset by declines due to competition within the high efficacy class.

美國 TYSABRI 的營收為 2.49 億美元，下降 4%，這得益於本季度的發貨時間，但由於高效能類別內的競爭造成的下降抵消了這一影響。

Next, our rare disease franchise produced revenue of $534 million and that represented growth of 22% at actual currency and 25% at constant currency.

接下來，我們的罕見疾病特許經營業務產生了 5.34 億美元的收入，以實際貨幣計算增長了 22%，按固定匯率計算增長了 25%。

SKYCLARYS global revenue was $100 million.

SKYCLARYS 全球營收為 1 億美元。

Global SPINRAZA revenue of $429 million declined 2% at actual currency and was flat at constant currency.

全球 SPINRAZA 營收為 4.29 億美元，以實際貨幣計算下降 2%，以固定匯率計算持平。

US revenue was up 1% to $157 million, and we remain encouraged by the resilience here.

美國營收成長 1%，達到 1.57 億美元，我們仍然對這裡的韌性感到鼓舞。

And on LEQEMBI, we saw significant sequential growth with second quarter global in-market sales booked by Eisai of approximately $40 million, which included $30 million of US in-market sales.

在 LEQEMBI 上，我們看到了顯著的環比成長，衛材第二季的全球市場銷售額約為 4,000 萬美元，其中包括 3,000 萬美元的美國市場銷售額。

I'll turn now to a few comments on expenses.

我現在談談有關費用的一些評論。

We continue to see lower non-GAAP cost of sales as a percentage of revenue, which was driven by a more favorable product mix, notably growth in SKYCLARYS replacing lower margin contract manufacturing revenue.

我們繼續看到非公認會計準則銷售成本佔收入的百分比下降，這是由更有利的產品組合推動的，特別是 SKYCLARYS 的成長取代了利潤率較低的合約製造收入。

We also had no idle capacity charges during the quarter versus $34 million in the second quarter of 2023.

本季我們也沒有閒置產能費用，而 2023 年第二季的閒置產能費用為 3,400 萬美元。

As mentioned previously, our R&D prioritization and fit for growth programs have begun to significantly improve our profitability.

如前所述，我們的研發優先順序和適合成長計畫已開始顯著提高我們的獲利能力。

Second quarter non-GAAP R&D expense decreased from the second quarter of 2023 by $120 million or 21% as we continue to focus our spend on programs with the highest probability of success.

第二季非 GAAP 研發費用較 2023 年第二季減少 1.2 億美元，即 21%，因為我們繼續將支出集中在成功機率最高的項目上。

Non-GAAP SG&A expense increased 1% in the second quarter.

第二季非 GAAP SG&A 費用成長 1%。

We have significantly reduced selling costs for legacy products and also significantly reduced our general and administrative cost base, which has allowed us to absorb most of the approximately $100 million of Q2 2024 incremental launch costs for LEQEMBI and SKYCLARYS.

我們大幅降低了傳統產品的銷售成本，也顯著降低了我們的一般和管理成本基礎，這使我們能夠吸收LEQEMBI 和SKYCLARYS 2024 年第二季約1 億美元的增量推出成本中的大部分。

Now, a brief update on our balance sheet.

現在，簡要更新我們的資產負債表。

We ended the second quarter with $1.9 billion of cash and marketable securities.

第二季結束時，我們擁有 19 億美元的現金和有價證券。

As a reminder, we utilized $1.15 billion of this balance in July when we closed the HI-Bio acquisition.

提醒一下，我們在 7 月完成對 HI-Bio 的收購時動用了該餘額中的 11.5 億美元。

We ended the quarter with approximately $4.4 billion of net debt.

本季結束時，我們的淨債務約為 44 億美元。

During the quarter, we fully repaid the remaining balance of the $1 billion term loan that we put in place at the time of the Reata acquisition.

本季度，我們全額償還了收購 Reata 時發放的 10 億美元定期貸款的剩餘餘額。

And we continue to generate strong cash flow in the second quarter with approximately $592 million of free cash flow, which brings us to approximately $1.1 billion of free cash flow in the first half of 2024.

我們在第二季度繼續產生強勁的現金流，自由現金流約為 5.92 億美元，這使我們在 2024 年上半年的自由現金流達到約 11 億美元。

We continue to believe that our balance sheet has the capacity for us to invest in both internal and external growth opportunities.

我們仍然相信我們的資產負債表有能力投資於內部和外部成長機會。

Turning now to guidance.

現在轉向指導。

We're pleased that the operating performance of the business year-to-date supports raising our full year 2024 non-GAAP diluted EPS guidance from a previous range of $15 to $16 to a new range of between $15.75 to $16.25. This new range reflects expected growth of approximately 9% at the midpoint of the range compared to the full year of 2023.

我們很高興該業務今年迄今的經營業績支持我們將 2024 年全年非 GAAP 攤薄每股收益指引從之前的 15 美元至 16 美元範圍提高到新的 15.75 美元至 16.25 美元範圍。這一新範圍反映了與 2023 年全年相比，該範圍中點預計將增長約 9%。

I would like to highlight several important things to remember for the second half of 2024 as you update your models.

我想強調 2024 年下半年更新模型時需要記住的幾件重要事情。

In terms of revenue, with our key products all performing generally in line or slightly ahead of expectations, there is a slight increase to the previous expectations for the year.

營收方面，主要產品表現基本符合或略超預期，較先前預期略有成長。

We now expect full year total revenue to decline by a low-single-digit percentage when compared to 2023.

我們現在預計全年總收入與 2023 年相比將下降低個位數百分比。

We also expect core pharmaceutical revenue to be roughly flat year-over-year as recent launches are expected to progress and provide an offset to some key potential dynamics in the second half of the year.

我們也預期核心藥品收入將同比大致持平，因為近期的上市預計將取得進展，並抵消下半年一些關鍵的潛在動態。

These include expected continued pressure on our MS franchise, which incorporates the potential for a biosimilar entrant in the US for TYSABRI.

其中包括預期我們的 MS 特許經營權將面臨持續壓力，其中包括 TYSABRI 生物相似藥進入美國的潛力。

And we continue to monitor the timing of shipments for SPINRAZA in certain ex-US markets.

我們將繼續監控 SPINRAZA 在某些美國以外市場的出貨時間。

Next, the sale of one of our two priority review vouchers is a non-recurring item.

接下來，我們的兩張優先審核優惠券之一的銷售是非經常性項目。

And since we expect to reinvest the proceeds of this sale and growth initiatives later this year, we do not expect this benefit to impact our full year EPS.

由於我們預計將在今年稍後將此次銷售和成長計劃的收益進行再投資，因此我們預計這一收益不會影響我們的全年每股收益。

Also, some key points to consider regarding our operating expenses.

此外，關於我們的營運費用需要考慮的一些要點。

In the second half of the year, we expect to continue to ramp launch spending on our new product launches.

下半年，我們預計將持續增加新產品發表的投入。

This will include the 30% increase in the LEQEMBI field force, which is coming online as well as additional spend for some targeted direct-to-consumer campaigns.

這將包括即將上線的 LEQEMBI 現場人員數量增加 30%，以及一些有針對性的直接面向消費者的活動的額外支出。

In addition, we expect incremental OpEx, primarily on the R&D line, of approximately $50 million in the back half of the year related to HI-Bio as we execute plans on three potential Phase 3 starts.

此外，隨著我們執行三個潛在的第 3 階段啟動計劃，我們預計今年下半年與 HI-Bio 相關的增量營運支出（主要是研發線）將達到約 5000 萬美元。

We continue to expect full year 2024 combined non-GAAP R&D and SG&A expense of approximately $4.3 billion.

我們仍預期 2024 年全年非 GAAP 研發與銷售、一般管理費用總計約 43 億美元。

Reported approximately $2 billion of spend in the first half of the year, implying higher spend in the second half of the year due to the reasons I just mentioned, along with some typical phasing of expenses throughout the year.

根據報告，今年上半年的支出約為 20 億美元，這意味著由於我剛才提到的原因以及全年一些典型的分階段支出，下半年的支出會更高。

I would also note that we now expect 2024 operating income to grow at a mid to high teen percentage versus the previous guide of a low double-digit percent growth.

我還要指出的是，我們現在預計 2024 年營業收入將以中等到高的青少年百分比增長，而之前的指導為低兩位數百分比增長。

This improvement factors in higher expenses in the second half of the year versus the first half of the year, partially offset by higher revenue due to our new product launches.

這項改善導致下半年費用高於上半年，但部分被我們新產品推出帶來的收入增加所抵銷。

I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024, and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition.

我想提醒您的是，我們預計 2024 年剩餘時間內利息收入將減少約 2000 萬美元，這是由於現金餘額減少以及收購 HI-Bio 帶來的相關利息收入減少。

As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict.

像往常一樣，我們的指導意見沒有考慮任何潛在收購或大型業務發展交易或未決和未來訴訟的影響，因為這些通常難以預測。

I would refer to you to our press release for other important guidance assumptions.

我建議您參閱我們的新聞稿以了解其他重要的指導假設。

And just before we open it up for Q&A, I wanted to provide a brief update regarding the strategic review of our biosimilars business.

就在我們開始問答之前，我想提供有關我們生物相似藥業務策略審查的簡短更新。

After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability.

在將潛在的外部化選項與保留業務進行比較後，我們認為，未來股東的最佳價值是將業務保留在我們的投資組合中，並優化業務，以實現利潤最大化。

And with that, we will open up the call for questions.

至此，我們將開始提問。

Thanks, Mike.

謝謝，麥克。

Operator, can we please poll for questions?

接線員，我們可以投票詢問問題嗎？

(Operator Instructions).

（操作員說明）。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Good morning.

早安.

Congratulations on the quarter.

恭喜本季。

At a high level, there's been significant focus on 2024 as a turning point for the company, both product wise for the launches and operationally given the cost savings programs and pipeline prioritization.

從高層來看，人們非常關注 2024 年是公司的轉捩點，無論是在產品發布方面，還是在營運方面考慮到成本節約計畫和管道優先順序。

Just given the raised guidance here of 9% year-over-year EPS growth for this year, can you just speak to your confidence around 2023 being the trough year for earnings and what needs to play out from here for clean growth through the end of the decade?

剛剛給了今年每股收益同比增長 9% 的指導意見，您能否談談您對 2023 年左右盈利的谷底年的信心，以及從這裡到年底需要實現什麼清潔增長？

Thank you.

謝謝。

Yeah, thank you for the question, Salveen.

是的，謝謝你的提問，薩爾文。

And our mission at Biogen remains to bring ourselves to sustainable growth on both the top line and the bottom line.

我們百健（Biogen）的使命仍然是實現營收和利潤的可持續成長。

Obviously, our original guidance, which implied growth of 5% on the bottom line at the midpoint and now 9% at the midpoint, shows that we've now turned the corner on the bottom line and we're very focused on our cost savings program, which importantly not only improve our operating performance, but also free up capital for growth initiatives.

顯然，我們最初的指導意味著中點淨利潤增長 5%，現在中點增長 9%，這表明我們現在已經扭轉了淨利潤的困境，我們非常注重節省成本計劃，重要的是不僅可以提高我們的營運績效，還可以釋放資金用於成長計畫。

So that's real important.

所以這真的很重要。

Obviously, we don't guide beyond 2024.

顯然，我們的指導不會超過 2024 年。

But I would say that, when you look at our guidance this year, we're pleased with the fact that we've been able to get our top line somewhat much more stabilized and we've got the bottom line growing again as we look to next year.

但我想說的是，當你看看我們今年的指導時，我們很高興我們能夠使我們的營收更加穩定，並且我們的盈利再次增長。

We're pleased with the progress of the launches.

我們對發布的進展感到滿意。

Our ability to restore the top line is going to be somewhat dependent on how those launches continue to perform along with how the MS franchise continues to sustain and be durable.

我們恢復營收的能力將在一定程度上取決於這些產品的持續表現以及 MS 專營權如何繼續維持和持久。

And what I can say is that we're very focused on bringing the company back to growth.

我能說的是，我們非常專注於讓公司恢復成長。

And we're certainly hopeful that 2023 was the trough year.

我們當然希望 2023 年是低谷年。

And obviously, we're doing a nice job growing the bottom line in 2024 and we'll have more to say about the out-years as we move to the latter part of this year and into early next.

顯然，我們在 2024 年實現利潤成長方面做得很好，隨著今年下半年和明年初的到來，我們將對未來幾年有更多話要說。

Thanks, Mike.

謝謝，麥克。

Can we take our next question, please, operator?

接線員，我們可以回答下一個問題嗎？

Mohit Bansal, Wells Fargo.

莫希特·班薩爾，富國銀行。

Hi, this is (inaudible) on for Mohit.

大家好，這是 Mohit 的（聽不清楚）。

Thanks for taking our questions.

感謝您回答我們的問題。

I had a question on the EMA decision on LEQEMBI.

我對 EMA 關於 LEQEMBI 的決定有疑問。

Do you plan to submit additional evidence on efficacy or safety from trials or from real world evidence to reverse this position?

您是否計劃提交來自試驗或現實世界證據的關於功效或安全性的額外證據來扭轉這一立場？

And what's your confidence that the decision can be reversed?

您對撤銷該決定的信心有多大？

And what should we think about for timeline for the EMA to reconsider and would a [SAG] need to be convened for this process?

對於 EMA 重新考慮的時間表，我們應該考慮什麼？

Thanks.

謝謝。

Thank you.

謝謝。

This is Priya Singal.

我是普里亞·辛格爾。

We are very disappointed, along with Eisai, at the outcome of the negative opinion for LEQEMBI.

我們與衛材一起對 LEQEMBI 的負面意見結果感到非常失望。

We continue to believe that the benefit risk is positive and favorable.

我們仍然認為收益風險是積極且有利的。

As you know, it's been approved in major regions of the world like the United States, China, Japan, and recently, we've also communicated approvals in Hong Kong, Israel as well as South Korea.

如您所知，它已在美國、中國、日本等世界主要地區獲得批准，最近我們也通報了香港、以色列和韓國的批准。

So, yes, we have communicated publicly and I can reaffirm that we will be applying for a re-examination process.

所以，是的，我們已經公開溝通，我可以重申我們將申請重新審查程序。

The way the re-examination process works is that you can continue to work with a newly appointed rapporteur and co-rapporteur for the process.

重新審查過程的運作方式是，您可以繼續與新任命的報告員和聯合報告員合作進行此過程。

So, right now, we would wait to receive the assessment report from the CHMP, the new rapporteur and co-rapporteur would be appointed and then we would work with them to understand what are the issues that are driving the decision.

因此，現在，我們將等待收到 CHMP 的評估報告，將任命新的報告員和聯合報告員，然後我們將與他們合作，以了解推動該決定的問題是什麼。

And currently, based on the opinion that was rendered, we believe these are addressable with the data that we've generated.

目前，根據所提出的意見，我們相信這些問題可以透過我們產生的數據來解決。

Specifically, we have generated long-term data as we shared at AAIC and we would look to be engaging with the EMA and CHMP to see how we can submit additional data and the extensive real-world data that we have in the real world because thousands of patients now have been treated.

具體來說，我們已經產生了在 AAIC 上共享的長期數據，我們希望與 EMA 和 CHMP 合作，了解如何提交額外的數據以及我們在現實世界中擁有的廣泛的真實數據，因為數千的患者現已接受治療。

So we have long-term continued benefit as we showed in the three year data at AAIC and also long-term safety.

因此，正如我們在 AAIC 的三年數據中所顯示的那樣，我們擁有長期持續的效益以及長期的安全性。

So we're continuing to work very closely with Eisai on the re-examination process and strategy.

因此，我們將繼續與衛材在重新審查流程和策略上密切合作。

It is possible that a new SAG-N would be appointed and this process would generally move faster than the original application.

可能會任命新的 SAG-N，並且此過程通常會比原始申請更快。

All right.

好的。

Thanks for the details, Priya.

謝謝你的詳細信息，普里亞。

Next question, please.

請下一個問題。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO 資本市場。

Hi there.

你好呀。

It's Evan Seigerman.

我是埃文·西格曼。

Question for Priya.

問普里亞的問題。

Can you walk me through some of the rationale on opting out of the Angelman Syndrome Program with

您能否向我解釋一下選擇退出天使症候群計畫的一些理由？

[Ionis]?

[伊奧尼斯]？

How has your approach to evaluating partnerships evolved recently and what aspects of a program do you now more closely scrutinize when you're thinking about what to do with a partner?

您評估合作夥伴關係的方法最近發生了怎樣的變化？

Thank you.

謝謝。

I think just stepping back, I want to point us to comments we've made externally before as well that we have really -- we really looked at our readouts as important inflection points which allow us to double down, accelerate in those programs if the data are objectively clear and compelling.

我想退一步，我想向我們指出我們之前在外部發表的評論，我們確實將我們的讀數視為重要的拐點，這使我們能夠加倍努力，加速這些計劃，如果數據客觀清晰、令人信服。

And then the other option would be that we can pivot and pivot to other programs that we may be considering.

然後另一個選擇是我們可以轉向我們可能正在考慮的其他計劃。

So overall, our process is that we develop up a priority go-no-go criteria.

總的來說，我們的流程是製定一個優先的「不走」標準。

And based on that, we decide what the probability technical and regulatory success is in a particular program.

在此基礎上，我們決定特定計劃在技術和監管方面取得成功的可能性。

And that is exactly the approach that we applied with the Angelman Syndrome -- the BIIB121 data.

這正是我們對 Angelman 症候群（BIIB121 資料）所應用的方法。

That is going to be continuing to be the way that we look at all our readouts and we try to be very disciplined.

這將繼續成為我們查看所有讀數的方式，我們將努力保持嚴格的紀律。

I think things that we find very compelling are biomarkers, established regulatory pathways, clinical tractability as well as our confidence in regulatory endpoints or on our interact -- based on interactions with regulators.

我認為我們發現非常引人注目的事情是生物標誌物、既定的監管途徑、臨床可處理性以及我們對監管終點或我們的互動的信心——基於與監管機構的互動。

So we look at all of these and that's how we think about investment in Phase 3.

所以我們會考慮所有這些，這就是我們對第三階段投資的看法。

If I could just add, I think, in addition to what Priya said, we're also looking at the ability to launch products globally.

我想補充一下，除了 Priya 所說的之外，我們還在考慮在全球推出產品的能力。

And so, we also are interested in the level of evidence and regulatory endpoints as they may be acceptable to payers and regulators around the world and not just in the US.

因此，我們也對證據等級和監管終點感興趣，因為它們可能被世界各地的付款人和監管機構所接受，而不僅僅是美國。

Great.

偉大的。

Thank you both.

謝謝你們倆。

Next question, please, operator.

接線員，請下一個問題。

Michael DiFiore, Evercore ISI.

邁克爾·迪菲奧裡，Evercore ISI。

Hi, guys.

嗨，大家好。

Thanks so much for taking my question, and congrats on the quarter.

非常感謝您提出我的問題，並祝賀本季。

So I was wondering if there's any updates on the induction dose optimization work you're doing and whether this could lead to a more optimal risk benefit ratio that the EMA is looking for?

所以我想知道你們正在進行的誘導劑量優化工作是否有任何更新，以及這是否可以帶來 EMA 正在尋找的更好的風險收益比？

Yes.

是的。

So, overall, as Eisai and Biogen have communicated, we continue to -- we've already filed for the IV maintenance and we have a fast track and a rolling submission in place for the subcutaneous maintenance dosing.

因此，總體而言，正如衛材和百健（Biogen）所傳達的那樣，我們將繼續進行——我們已經申請了靜脈注射維持用藥，並且我們為皮下維持劑量提供了快速通道和滾動提交。

With the initiation of subcutaneous dosing, we are looking at optimizing the dose.

隨著皮下給藥的開始，我們正在考慮優化劑量。

We're continuing to work with FDA on this effort.

我們將繼續與 FDA 合作進行這項工作。

And currently, we are on track, as we've communicated, to have an outcome on this from the FDA in the US by Q1, calendar year Q1 2026.

目前，正如我們所傳達的那樣，我們預計在 2026 年第一季（即第一季）之前從美國 FDA 獲得對此的結果。

Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that's currently, we're going to pursue re-examination is dependent on the original application, which is really for intravenous LEQEMBI.

現在，關於您關於這將如何影響歐洲申請的具體問題，我只想明確表示，目前我們將進行重新審查的歐洲申請取決於原始申請，即真正用於靜脈注射 LEQEMBI。

We would hope that we can get that a favorable outcome at the end of the reexamination process.

我們希望在復審過程結束時能夠得到有利的結果。

And if so, we would continue down the path of again providing options to patients as well as in Europe with subcutaneous formulation.

如果是這樣，我們將繼續沿著再次為患者以及歐洲提供皮下製劑選擇的道路。

Thank you, Priya.

謝謝你，普里亞。

Next question, please.

請下一個問題。

Chris Raymond, Piper Sandler.

克里斯·雷蒙德，派珀·桑德勒。

Thanks.

謝謝。

This is Nicole Gabreski on for Chris.

我是克里斯的妮可·加布雷斯基。

Maybe just one on LEQEMBI.

也許只有 LEQEMBI 上的一個。

So some of our survey work we've done recently with neurologists and Alzheimer's specialists has kind of indicated maybe a less favorable view of the risk/benefit and cost/benefit ratios for LEQEMBI in recent quarters.

因此，我們最近與神經科醫生和阿茲海默症專家進行的一些調查工作表明，最近幾個季度 LEQEMBI 的風險/效益和成本/效益比可能不太樂觀。

And I guess we're starting to see some feedback from docs also questioning the amyloid hypothesis as a whole.

我想我們開始看到一些來自醫生的回饋也質疑整個澱粉樣蛋白假說。

I guess maybe just given this, could you speak to the interactions and/or feedback that reps are having in the field.

我想也許只是考慮到這一點，您能否談談代表在現場進行的互動和/或回饋。

I guess, are you starting to maybe experience any pushback as you move from HPPs who are sort of ready and waiting to prescribe LEQEMBI soon after approval to those who are in the next wave of uptake?

我想，當您從準備好並等待在批准後不久開出 LEQEMBI 的 HPP 轉向那些處於下一波使用的人時，您是否開始遇到任何阻力？

Thank you for the question.

謝謝你的提問。

This is Alisha.

這是艾莉莎。

Whenever we look at market research, I think it's important to understand who you're asking in the market research.

每當我們進行市場研究時，我認為了解您在市場研究中詢問的對像很重要。

And so, when we look at what's happening in the field, at least on the ground, when you're asking the physicians, if you were to parse out market research and ask the physicians who are currently obviously prescribing, and the ones who aren't, the ones who are prescribing are the ones that we've been working really hard on over this past year.

因此，當我們看看該領域正在發生的事情時，至少在實地，當你詢問醫生時，你是否要解析市場研究並詢問目前明顯在開處方的醫生以及那些沒有開處方的醫生不是的，正在開處方的是我們在過去一年裡一直在努力工作的那些。

They're the ones that understand the data, they've been visited by MSLs, they've been visited by representatives and then it takes them time to obviously get up and running with their facility.

他們是了解數據的人，MSL 拜訪了他們，代表也拜訪了他們，然後他們顯然需要時間來啟動並運行他們的設施。

You also then see across the board that other physicians see this happening and some in, like, a nearer location will also start obviously picking up the product.

然後，您還可以全面看到其他醫生看到這種情況發生，並且一些在更近的位置的醫生也會明顯開始拿起該產品。

And so, on the ground and with our representatives, they go from office-to-office.

因此，他們在現場和我們的代表一起從一個辦公室到另一個辦公室。

We're obviously expanding now as well with the additional field force.

顯然，我們現在也在擴大規模，增加了現場人員。

And what we've seen is the ones that you call on are the ones that actually start writing.

我們看到的是，那些被你召喚的人實際上開始寫作。

And there's a lot of dynamics at play here.

這裡有很多動態在發揮作用。

I think that understanding this data is important.

我認為理解這些數據很重要。

I think understanding all the mechanics in order to get a patient diagnosed is important and having them set up their capacity is important.

我認為了解患者診斷的所有機制很重要，並且讓他們建立自己的能力也很重要。

So, we don't really hear any pushback about cost benefit.

因此，我們確實沒有聽到任何有關成本效益的阻力。

I can say that.

我可以這麼說。

And I think more importantly, what we're hearing now is because we are a year out, we're starting to really get the real world experience feedback from physicians on the impact this is having on patients and the caregivers and the families.

我認為更重要的是，我們現在聽到的是，因為我們已經過去一年了，我們開始真正從醫生那裡得到真實世界的經驗回饋，了解這對病人、照護者和家庭的影響。

And I think that alone has really also accelerated some of these physicians to try and treat patients even more quickly.

我認為僅此一點就確實加速了其中一些醫生嘗試更快地治療患者的速度。

And so, for now, we're not really hearing that pushback.

因此，目前我們還沒有真正聽到這種阻力。

And if I could just add to that, after decades of this, I tend to pay more attention to what physicians do versus what they say.

如果我可以補充一點的話，經過幾十年的這種情況，我傾向於更加關注醫生的做法而不是他們所說的話。

And this is a very heavy lift for physicians to introduce this treatment into their practices and institutions.

對於醫生來說，將這種治療方法引入他們的實踐和機構是一項非常艱鉅的任務。

And when you look at the number of the increase of 50% of physicians writing this and the depth of ordering from the IDNs, we're seeing a lot of physicians investing huge amounts of time and energy to actually get through all of the processes, schedule the PET scans or the lumbar punctures, the MRIs.

當你看到寫這篇文章的醫生數量增加了 50% 以及從 IDN 訂購的深度時，我們看到很多醫生投入了大量的時間和精力來實際完成所有流程，安排 PET 掃描或腰椎穿刺、MRI。

And to me, you don't do that if you don't have a strong conviction in the importance of this treatment to patients.

對我來說，如果您對這種治療對患者的重要性沒有堅定的信念，您就不會這樣做。

So, personally, as I look at this, I'm extremely encouraged by where we are.

因此，就我個人而言，當我看到這一點時，我對我們的現狀感到非常鼓舞。

I think now, for the first time since the launch, we can look forward to the growth of this market, not just because of the prescriptions, but I look at the evidence base that we are building with our partners at Eisai on LEQEMBI.

我認為，自推出以來，我們第一次可以期待這個市場的成長，不僅是因為處方，而且我看到了我們與衛材合作夥伴在 LEQEMBI 上建立的證據基礎。

It's very clear now from the three year data that it probably is not going to be enough to just remove the plaque.

從三年的數據來看，現在非常清楚，僅僅去除牙菌斑可能是不夠的。

We'll need to continue to treat patients.

我們需要繼續治療病人。

And again, as I was saying earlier, with the AHEAD study, we hope to show that there is a benefit to treating earlier.

正如我之前所說，透過 AHEAD 研究，我們希望證明早期治療是有好處的。

So this market is going to grow and the evidence base is going to grow.

所以這個市場將會成長，證據基礎也會成長。

It is market building that we're doing and that certainly takes time and patience.

我們正在做的是市場建設，當然需要時間和耐心。

But as I've said in the past that it's difficult to predict where we're going to go.

但正如我過去所說，很難預測我們將走向何方。

With this quarter, I think we're seeing we're on a very solid track.

在本季度，我認為我們正走在一條非常堅實的軌道上。

And I think the entry of Lilly will only accelerate the development of this marketplace.

我認為禮來公司的進入只會加速這個市場的發展。

Thank you.

謝謝。

Let's take our next question, please.

請讓我們回答下一個問題。

Brian Abrahams, RBC Capital Markets.

布萊恩‧亞伯拉罕斯 (Brian Abrahams)，加拿大皇家銀行資本市場部。

Hi, everyone.

大家好。

This is Nevin on for Brian here.

我是內文 (Nevin) 替布萊恩 (Brian) 發言。

Congrats on a good quarter and thank you in advance for taking our questions.

恭喜您度過了一個美好的季度，並提前感謝您回答我們的問題。

I just wanted to ask a little bit more about the SKYCLARYS dynamics that we're seeing, specifically what you're seeing on patient persistence or potential discontinuation rates there.

我只是想更多地了解我們所看到的 SKYCLARYS 動態，特別是您所看到的患者堅持性或潛在停藥率。

Some of the educational efforts that you're taking to kind of convince the patients to remain on therapy even if they're not seeing the efficacy of the therapy right away.

您正在採取一些教育措施來說服患者繼續接受治療，即使他們沒有立即看到治療的效果。

And maybe if you could speak a little bit more to some of the perceptions that patients and doctors may have on the cardiac safety and benefits there as well.

也許您可以多談談患者和醫生對心臟安全和益處的一些看法。

Thanks.

謝謝。

All right.

好的。

Thank you for the question.

謝謝你的提問。

This is Alisha.

這是艾莉莎。

First, we are very pleased with what we're seeing right now, especially globally and in the US with SKYCLARYS and as I've mentioned before, we're past the catch-up population and we're now really into the patient identification phase.

首先，我們對目前所看到的情況感到非常滿意，特別是在全球和美國的 SKYCLARYS，正如我之前提到的，我們已經超越了追趕人群，我們現在真正開始進行患者識別階段。

We look at every metric from discon, compliance, adherence, start times.

我們會考慮從拒絕、合規、遵守、開始時間等各方面的指標。

And when it comes to discons, we do not see anything outside of what you see in the clinical trials.

當涉及缺點時，我們沒有看到除了臨床試驗中看到的以外的任何東西。

And so, the discontinuation rate is not anything more than obviously what we also saw in trials.

因此，停藥率與我們在試驗中看到的情況一樣明顯。

I think when it comes to efficacy of the patients, physicians have been really good on setting expectations with patients on what to expect from SKYCLARYS.

我認為，當涉及患者的療效時，醫生非常善於為患者設定對 SKYCLARYS 的期望。

The field teams do a really good job of also educating both physicians and educational materials with patients on what to expect when you start this product.

現場團隊在向醫生和患者提供教育材料方面做得非常出色，讓他們了解開始使用產品時會發生什麼。

And so, you do see that patients tend to stay on product and physicians are very good also about saying to patients, at least stay on it for a year and let's talk about how you're feeling and where we're going and what we're seeing as adherence has been actually very good.

因此，您確實看到患者傾向於繼續使用產品，醫生也非常善於對患者說，至少堅持使用一年，讓我們談談您的感受以及我們的目標以及我們的目標我們發現，遵守情況實際上非常好。

I think the other dynamic that's playing out that you could be referring to is because we're now in the patient identification phase, you are going to see a little bit of difference from week-to-week and month-to-month.

我認為您可能提到的另一個動態是因為我們現在處於患者識別階段，您將看到每周和每月的一些差異。

And we are adding patients every single week.

我們每週都會增加患者。

We're also adding them every single month.

我們每個月也會添加它們。

And we acquire new data on a regular basis.

我們定期獲取新數據。

And what we're seeing, at least recently, and I was sharing this with Chris the other day.

我們所看到的，至少最近，我前幾天與克里斯分享了這一點。

We have this new AI engine that we've been deploying and we have identified significant number of additional coded FA patients that we didn't even have at the beginning of launch because we're starting to see that patients are engaging even more with their physicians.

我們已經部署了這個新的人工智慧引擎，並且已經識別出大量額外的編碼 FA 患者，而這些患者在發布之初甚至沒有，因為我們開始看到患者更多地參與他們的治療醫生。

And so, now we're able to reach them with more efficiency and with more certainty across the board.

因此，現在我們能夠更有效率、更確定地全面實現這些目標。

And I think it's been very promising as we find new patients to come on.

我認為隨著我們發現新患者的出現，這是非常有希望的。

All right.

好的。

Thanks, Alicia.

謝謝，艾莉西亞。

Next question, please.

請下一個問題。

Paul Matteis, Stifel.

保羅馬蒂斯，斯蒂菲爾。

Great.

偉大的。

Thanks so much for taking my question.

非常感謝您提出我的問題。

I think over the past year, Biogen's commentary on business development capacity has evolved a couple of times more recently, I think you said around $10 billion, maybe minus the HI-Bio deal.

我認為在過去的一年裡，百健（Biogen）對業務發展能力的評論最近發生了幾次變化，我想你說的是大約 100 億美元，可能減去 HI-Bio 交易。

I guess just kind of going forward in 2024 or the near to mid-term, what's Biogen's appetite for bigger transactions or Reata like transaction and what's the updated thinking on specific therapeutic areas or types of assets of interest?

我想在 2024 年或近中期，百健（Biogen）對更大交易或類似 Reata 的交易的興趣是什麼？

Thank you.

謝謝。

Yeah, I'll take that one.

是的，我會接受那個。

I think first in terms of where we're looking, I think we're already long neuroscience.

我認為首先就我們正在尋找的方向而言，我認為我們已經長期從事神經科學了。

So we're probably looking outside of that space, immunology, rare diseases.

因此，我們可能正在尋找免疫學、罕見疾病領域以外的領域。

As I look at Biogen, I would say we have an extremely high scientific and medical capability within the company.

當我觀察百健（Biogen）時，我想說我們公司內部擁有極高的科學和醫療能力。

We have been historically a company that is in the low volume, high value area.

從歷史上看，我們一直是一家處於低產量、高價值領域的公司。

We really understand the necessity to assist patients and physicians for some expensive products to get through a reimbursement, provide and sponsor genetic testing, for example, thinking about studies and real-world evidence becomes extremely important in this.

我們真正理解幫助患者和醫生購買一些昂貴產品以獲得報銷、提供和贊助基因檢測的必要性，例如，考慮研究和現實世界的證據在這方面變得極其重要。

So I think there's a capability of Biogen in rare diseases.

所以我認為百健（Biogen）在罕見疾病方面有能力。

Immunology is really an area we've been in since we started with multiple sclerosis.

自從我們從多發性硬化症開始研究以來，免疫學確實是我們一直在研究的領域。

So I think we have the capabilities to go into those areas.

所以我認為我們有能力進入這些領域。

I think where we are now is we're on a growth pattern.

我認為我們現在處於成長模式。

If we could find another Reata type acquisition, I think we would look for that.

如果我們能找到另一個 Reata 類型的收購，我想我們會尋找。

But those come along pretty rarely.

但這些很少出現。

It's rare that you can find a company that is that close to the market.

很難找到一家如此貼近市場的公司。

In fact, it already launched by the time we actually had acquired that.

事實上，當我們真正獲得它時，它已經啟動了。

But acquire that for price that still creates shareholder value.

但以仍能創造股東價值的價格收購它。

And we will continue to look, but they don't come along every day.

我們將繼續尋找，但它們不會每天都出現。

And we're not in a position where I think we are desperate to do a deal.

我認為我們並不迫切希望達成協議。

I think if you look at what we've done with HI-Bio, for example, as an alternative to that, being able to launch more products in the sort of 2027 to 2030 timeframe is a priority for us.

例如，我認為，如果你看看我們在 HI-Bio 上所做的事情，作為替代方案，能夠在 2027 年至 2030 年的時間範圍內推出更多產品是我們的首要任務。

And that's why we're really also focused on the mid to late stage development process.

這就是為什麼我們也真正關注中後期開發流程。

But we can be picky.

但我們可以挑剔。

I think also where we look is not necessarily where everybody else is looking.

我認為我們所看的地方不一定是別人看的地方。

You really don't create value if you enter into these auction processes.

如果您進入這些拍賣流程，您實際上並沒有創造價值。

And so, I think by being able to stick to those areas where we think this is a really -- this is a space where Biogen can really be a strong player, we'll avoid overpaying.

因此，我認為，透過能夠堅持那些我們認為確實是百健（Biogen）真正可以成為強大參與者的領域，我們將避免支付過高的費用。

I think the other thing I would say is, Biogen is a nice size. $1 billion moves the needle hugely in our company.

我想我要說的另一件事是，百健（Biogen）的尺寸不錯。 10 億美元對我們公司來說意義重大。

There are a lot of bigger companies where $1 billion doesn't move the needle.

有很多大公司，10 億美元不能扮演什麼角色。

And so, I think we can look at assets where we have the capital that might be too small for some of the bigger players, but be too expensive for some smaller players.

因此，我認為我們可以考慮我們擁有的資產，這些資產對於一些較大的參與者來說可能太小，但對於一些較小的參與者來說太昂貴。

So I think in some ways, we're in a position where we can look for assets and not necessarily be in such competitive places where, again, you risk overpaying.

因此，我認為在某些方面，我們處於可以尋找資產的位置，而不必處於競爭激烈的地方，在那裡你再次面臨支付過高的風險。

But we're looking.

但我們正在尋找。

We take a systematic view.

我們採取系統性的觀點。

We're not going to take any sudden left turns strategically just because I'm not sure that that's really where the sweet spot is for Biogen.

我們不會在戰略上採取任何突然的左轉，只是因為我不確定這是否真的是百健（Biogen）的最佳位置。

But I do think there's a number of opportunities out there.

但我確實認為那裡有很多機會。

We also are doing a lot more in research on collaborations.

我們也在合作研究方面做了更多工作。

And I think one of the things I'd like to see us do is really bring a lot more assets in from an early stage because the earlier you can acquire these assets, the more shareholder value you can create.

我認為我希望看到我們做的一件事就是從早期階段引入更多資產，因為越早獲得這些資產，就能創造更多的股東價值。

Thanks, Chris.

謝謝，克里斯。

Next question, please.

請下一個問題。

Michael Yee, Jefferies.

麥可葉，杰弗里斯。

Hey, guys.

嘿，夥計們。

Thank you.

謝謝。

Earlier in the call, you commented about an emerging lupus portfolio and I know that you do have some upcoming lupus data.

在電話會議的早些時候，您評論了一個新興的狼瘡投資組合，我知道您確實有一些即將發布的狼瘡數據。

We've looked at the prior data.

我們查看了先前的數據。

There are reasons to believe that longer treatment and a bigger study could help here.

有理由相信，更長期的治療和更大規模的研究可能會有所幫助。

Can you just speak to your expectations?

能簡單談談您的期望嗎？

What are you looking for, what needs to happen to move forward, et cetera?

您在尋找什麼，需要發生什麼才能繼續前進，等等？

Thank you.

謝謝。

Yeah, thank you.

是的，謝謝。

This is Priya Singhal.

這是普里亞·辛格爾。

So, overall, we are excited about the readout for DAPI.

因此，總的來說，我們對 DAPI 的讀數感到興奮。

It is upcoming in the next several weeks.

它將在接下來的幾週內推出。

This is a partnered program with UCB and the collaboration is in a very good place.

這是與 UCB 的合作項目，合作非常順利。

We are expecting a headline or top line results of the first global Phase 3 trial.

我們期待首個全球 3 期試驗的頭條新聞或頂線結果。

And specifically, I want to be clear that this study is investigating, in this very high unmet disease area, the safety and efficacy of DAPI as an add-on to standard SLE therapy versus placebo as an add on to standard SLE therapy.

具體來說，我想明確的是，這項研究正在調查這個非常未滿足的疾病領域，DAPI 作為標準 SLE 治療的附加療法與安慰劑作為標準 SLE 療法的附加療法的安全性和有效性。

We are conducting the study in patients who have persistent active or frequent flaring despite stable standard of care.

我們正在對儘管護理標準穩定但仍持續活躍或頻繁發作的患者進行這項研究。

And very similar to the Phase 1 and Phase 2, we will be looking at efficacy assessed by BILAG based composite lupus assessment, or BICLA, but different than the Phase 2 study, it will take place over the 48 weeks to demonstrate the long-term effect.

與 1 期和 2 期研究非常相似，我們將研究基於 BILAG 的複合狼瘡評估（BICLA）評估的療效，但與 2 期研究不同，它將在 48 週內進行，以證明長期效果影響。

We also increased the sample size to provide a substantial dataset on safety and efficacy.

我們還增加了樣本量，以提供大量有關安全性和有效性的資料集。

Eventually and ultimately, we'll be looking for a meaningful change on the primary endpoint and key secondaries such as severe flare prevention, patients achieving low dose activity.

最終，我們將尋求對主要終點和關鍵次要終點（例如嚴重耀斑預防、患者實現低劑量活動）進行有意義的改變。

And we really think that BICLA is a sensitive clinically meaningful composite for SLE disease activity that requires disease improvement across all body symptoms with moderate or severe baseline activity without the need for escalation in steroids or other background medications as well as without worsening.

我們確實認為BICLA 是一種針對SLE 疾病活動的敏感的具有臨床意義的複合藥物，需要改善所有身體症狀並具有中度或重度基線活動，而不需要增加類固醇或其他背景藥物的用量，也不會惡化。

So we're looking forward to this.

所以我們對此充滿期待。

In addition to an acceptable safety and tolerability profile, we think this could be really meaningful for patients suffering from SLE.

除了可接受的安全性和耐受性外，我們認為這對於患有系統性紅斑狼瘡的患者來說可能非常有意義。

So if the results warrant continuing development, at this point, we expect to have the need to run another Phase 3, but we are planning some of this at-risk right now.

因此，如果結果值得繼續開發，那麼此時我們預計需要進行另一個第 3 階段，但我們現在正在計劃其中的一些風險。

Thanks, Priya.

謝謝，普里亞。

Next question, please.

請下一個問題。

Eric Schmidt, Cantor Fitzgerald.

埃里克·施密特，康托·菲茨傑拉德。

Thanks for taking my question.

感謝您提出我的問題。

Maybe for Chris, this call today seems to be like a relative high watermark in your tenure as CEO, given some of the initiatives that are now well in place and all that you've accomplished.

也許對克里斯來說，考慮到一些現已到位的舉措以及您所取得的所有成就，今天的這次電話會議似乎是您擔任執行長期間的一個相對較高的水位線。

And you certainly called that out in your prepared remarks.

您在準備好的發言中肯定指出了這一點。

You also called out that you've got some challenges and you're not done.

你也指出，你面臨一些挑戰，但你還沒完成。

So what in particular is top-of-mind there?

那麼，最重要的是什麼？

Thank you.

謝謝。

Well, thanks for the question.

嗯，謝謝你的提問。

I would hope it's not the high watermark because we're aiming much higher here, I can tell you.

我希望這不是高水位線，因為我們的目標更高，我可以告訴你。

I think, clearly, we've got still an MS franchise that is we're not done yet in terms of seeing the competitive threats.

我認為，很明顯，我們仍然擁有微軟的特許經營權，但我們還沒有看到競爭威脅。

There's potentially a biosimilar for TYSABRI, we have an important patent litigation that we'll see in the fall for TECFIDERA in Europe and there is the market exclusivity that expires in February.

TYSABRI 可能有生物相似藥，我們將於秋季在歐洲看到 TECFIDERA 的一項重要專利訴訟，而且市場獨佔權將於 2 月到期。

So shorter term, there's always some chop in the water.

因此，從短期來看，總是會有一些困難。

But I think where we have an opportunity is, we have an amazing talent base inside of Biogen.

但我認為我們有機會的地方是，我們在百健內部擁有令人驚嘆的人才基礎。

As you all know, I've been in this business a long time, seen a lot of companies, I continue just to be impressed by the scientific and medical capability that we have in the company and we've got capital.

眾所周知，我從事這個行業已經很長時間了，見過很多公司，我仍然對我們公司擁有的科學和醫療能力以及我們擁有的資本印象深刻。

And so, I think we can do smart things with that capital.

因此，我認為我們可以利用這筆資金做一些明智的事情。

We've been busy transforming essentially passive capital into active capital.

我們一直忙於將被動資本本質上轉變為主動資本。

We had two priority review vouchers sitting on the shelf.

我們的架子上有兩張優先審查券。

The innovative nature of Biogen's products is such that we don't really need those vouchers because of the innovative products we bring to market anyway.

百健（Biogen）產品的創新性質使得我們實際上並不需要這些優惠券，因為無論如何我們都會將創新產品推向市場。

So we had this one priority review voucher sitting on the shelf for six years that we've now converted hopefully into an active asset.

因此，我們將這張優先審查憑證擱置了六年，現在我們希望將其轉換為活躍資產。

We sold it, but the objective is to spend that on milestones in business development in the second half.

我們賣掉了它，但目標是把它花在下半年業務發展的里程碑上。

If I look at HI-Bio, we took a year-and-a-half of fit for growth savings out of operating expense and transformed that into a growth opportunity with the acquisition of HI-Bio.

如果我看看 HI-Bio，我們從營運費用中節省了一年半的成長資金，並透過收購 HI-Bio 將其轉化為成長機會。

So where I see us is, I think we're we've been able to change the trajectory of the company.

所以我認為我們已經能夠改變公司的發展軌跡。

We've been able to release resources from the business and reinvest them intelligently and we've got great people that I think can do that with tremendous results.

我們已經能夠釋放業務資源並明智地進行再投資，而且我們擁有優秀的人才，我認為他們可以做到這一點並取得巨大的成果。

So, I think as we look towards the future, it's really building out now the R&D portfolio, both internally and externally.

因此，我認為，當我們展望未來時，現在實際上正在建立內部和外部的研發組合。

I'd like to make sure we are still an innovation company going forward that we're not just acquiring our future, but really investing in that.

我想確保我們仍然是一家不斷前進的創新公司，我們不僅要獲得未來，而且要真正投資。

So I think I'm now focused on the 2025 to 2030 timeframe.

所以我認為我現在關注的是 2025 年至 2030 年的時間框架。

I think we're in good shape to grow through that period, but I think we can do more to really take advantage of the capability in R&D.

我認為我們在這段時期的發展狀況良好，但我認為我們可以做更多的事情來真正利用研發能力。

And I think you'll see us continue to deploy capital with a lot of discipline but I think be able to turn passive capital into active capital and then into active growth.

我認為你會看到我們繼續以嚴格的紀律部署資本，但我認為能夠將被動資本轉變為主動資本，然後轉變為主動成長。

All right.

好的。

Thank you, Chris.

謝謝你，克里斯。

And thank you, everybody, for joining us today.

感謝大家今天加入我們。

IR team will remain available for any additional questions.

IR 團隊將隨時解答任何其他問題。

Thank you.

謝謝。

And once again, that does conclude today's conference.

今天的會議再次結束。

We thank you all for your participation.

我們感謝大家的參與。

You may now disconnect.

您現在可以斷開連線。