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Operator
Operator
Hello, and welcome to the fourth quarter and full year 2024 Teva Pharmaceutical Industries earnings conference call.
您好,歡迎參加 Teva Pharmaceutical Industries 2024 年第四季和全年財報電話會議。
My name is Alex, and I will be coordinating the call today.
我叫亞歷克斯,今天我將負責協調這場電話會議。
(Operator Instructions)
(操作員指令)
And I hand it over to your host, Chris Stevo, SVP, Investor Relations.
我將其交給主持人、投資者關係資深副總裁 Chris Stevo。
Please go ahead.
請繼續。
Chris Stevo - SVP, Investor Relations
Chris Stevo - SVP, Investor Relations
Thank you, Alex.
謝謝你,亞歷克斯。
Good morning and good afternoon, everyone.
大家早安,下午好。
I'd like to remind you briefly that we're going to be making forward-looking statements on this call.
我想簡要地提醒您,我們將在本次電話會議上做出前瞻性陳述。
Any statements we make are as of today only, and we undertake no obligation to update these statements afterwards.
我們所做的任何聲明均僅截至今日,我們不承擔隨後更新這些聲明的義務。
And if you have any questions about forward-looking statements, or other risk disclosures, please see our SEC filings under Forms 10-K and 10-Q.
如果您對前瞻性陳述或其他風險揭露有任何疑問,請參閱我們向美國證券交易委員會 (SEC) 提交的 10-K 和 10-Q 表格。
And with that, let me turn it over to Richard.
現在,讓我把話題交給理查。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thank you, Chris, and good morning, good afternoon, everybody.
謝謝你,克里斯,大家早安,下午好。
Thank you for dialing in for the call.
感謝您撥入電話。
Really excited to talk to you today about the 2024 performance of Teva and the lookout for 2025.
今天非常高興與您談論 Teva 2024 年的表現以及對 2025 年的展望。
So as usual, I'm going to go back to the strategy, the Pivot to Growth strategy.
因此,像往常一樣,我將回到這項策略,即「轉向成長」策略。
What we set out in 2023 and what we accomplished of this strategy in 2024.
我們在 2023 年制定了哪些策略,2024 年我們實現了哪些目標。
As you remember, is based on four pillars: delivering our growth engines, step-up innovation, create a sustainable generics powerhouse and focus of the business.
正如大家所記得的,它基於四大支柱:提供我們的成長引擎、加強創新、創造永續發展的仿製藥強國和業務重點。
And I'm really pleased to say that we've made really good progress across 2024 on all of these pillars.
我很高興地說,到 2024 年,我們在所有這些支柱上都取得了良好的進展。
As you'll see, AUSTEDO had another great year, up 34%.
如你所見,AUSTEDO 又度過了輝煌的一年,上漲了 34%。
You said you had a very strong year, beating its target of 100 million at 117 million and AJOVY grew at 18% and reached the $0.5 billion number.
您曾說過,今年公司業績非常強勁,用戶數量達到 1.17 億,超出了 1 億的目標,AJOVY 增長了 18%,達到了 5 億美元的數字。
And step up innovation, great progress there by Eric and his team, obviously, we saw the results of duvakitug at the end of last year, where we think we have best-in-class and best by design.
並且加強了創新,Eric 和他的團隊取得了巨大的進步,顯然,我們在去年年底看到了 duvakitug 的成果,我們認為我們擁有一流的設計和最佳的設計。
And olanzapine, we have the full safety data set, so we now know we don't have any PDSS in this patient population in this trial.
對於奧氮平,我們擁有完整的安全資料集,因此我們現在知道在本次試驗中該患者群體中不存在任何 PDSS。
And DARI, we've really moved fast into the clinic with ICS/SABA at 91% of sites that are recruited.
而且,DARI 已在 91% 的招募站點透過 ICS/SABA 快速進入臨床。
On the generics business, all regions are growing for the second year, straight, which is good and our product launches have shown good performance to drive that growth.
在仿製藥業務方面,所有地區均連續第二年實現成長,這是件好事,我們的產品發布表現出色,推動了這一成長。
And then on focus the business, it was good to see external endorsement of the improvement of Teva with all the credit ratings improving their outlook for the company.
然後專注於業務,很高興看到外界對 Teva 改善的認可,所有信用評級都改善了公司的前景。
And it's good to see that our TAPI business is back to growth, four quarters of growth and full year growth.
很高興看到我們的 TAPI 業務恢復成長,連續四個季度和全年實現成長。
So a really good start and really good progress on the Pivot to Growth strategy.
因此,這對於「轉向成長」策略來說是一個非常好的開端,並且取得了非常好的進展。
And how does this translate into growth?
那麼這如何轉化為成長呢?
Well, as you see, eight quarters of growth we've had now after another year of decline.
嗯,正如你所看到的,在經歷了一年的下滑之後,我們已經實現了八個季度的成長。
So there's a consistency here, which really pleases me, and congratulations to the team.
所以這裡是一致的,這真的讓我很高興,並向團隊表示祝賀。
Just like to highlight here just for transparency, we have highlighted that one-off payment we got from Sanofi in Q4 2023.
為了透明度起見,我們在此強調的是,我們強調了我們在 2023 年第四季從賽諾菲獲得的一次性付款。
But this performance puts us on track to hit our 5% CAGR that we committed to in 2027.
但這一業績使我們預計將實現 2027 年承諾的 5% 複合年增長率。
Now to give you a bit of detail on this and the numbers, what drove the 9% in revenue.
現在向您詳細介紹這一點和數字,看看是什麼推動了 9% 的收入成長。
I'll go into that in a bit of detail, but let's start at the high-level P&L. $16.5 billion of revenue, up 9% at the high end of our outlook.
我將詳細介紹這一點,但讓我們先從進階損益表開始。營收為 165 億美元,以我們預期的高點成長 9%。
Our adjusted EBITDA was $4.8 billion, also up 9% and our non-GAAP EPS of $2.49, up 10%.
我們的調整後 EBITDA 為 48 億美元,也成長了 9%,非 GAAP EPS 為 2.49 美元,成長了 10%。
Free cash flow, up 10%, also at $2.1 billion.
自由現金流成長 10%,也達到 21 億美元。
And it's good to see that our net debt to EBITDA is now close to touching 3 times.
很高興看到我們的淨債務與 EBITDA 之比現在接近 3 倍。
And I'll remind you all that we did give a guidance up twice throughout the year.
我要提醒大家,我們全年確實給了兩次指導。
So I think this performance is a strong performance and one we're very proud of.
所以我認為這次的表現非常出色,我們對此感到非常自豪。
But let me now go into a bit of detail as to what's behind this.
但現在讓我詳細地講講這背後的原因。
So all three of our businesses grew, our innovative business, our generics business and our API business.
因此,我們的三項業務,包括創新業務、仿製藥業務和 API 業務,都實現了成長。
As you see, led by AUSTEDO up 36%, close to $1.7 billion, really strong performance again, AJOVY up 18%, as I said, just over $0.5 billion, and UZEDY $117 million.
如你所見,其中AUSTEDO上漲36%,接近17億美元,再次表現強勁,AJOVY上漲18%,正如我所說,剛剛超過5億美元,UZEDY上漲1.17億美元。
The Generics business close to $9.5 billion, up 11% and API at 3%.
仿製藥業務接近 95 億美元,成長 11%,API 成長 3%。
So across all of our businesses, we've driven this 9% growth.
因此,在我們所有的業務中,我們都實現了 9% 的成長。
Now let's go into the innovative business first, so I want AUSTEDO.
現在我們先進入創新業務,所以我想要AUSTEDO。
I want to be clear, we are on target to hit our $2.5 billion in 2027.
我想明確一點,我們的目標是在 2027 年達到 25 億美元。
And you'll see why, why we're confident about that is because the US revenues of $1.642 billion is a 34% growth, and we've got strong TRx growth of 34% also.
您會明白為什麼我們對此充滿信心,因為美國的收入為 16.42 億美元,增長了 34%,而且我們的 TRx 也實現了 34% 的強勁增長。
I'd like to point to is a nice contribution from the rest of the world, now starting to kick in with $46 million.
我想指出的是來自世界其他地區的慷慨捐助,目前已開始提供 4,600 萬美元。
And because of this confidence, we have our outlook of $1.9 billion to just over $2 billion to 2025 I think, shows the strong belief we have in this product.
由於這種信心,我們預計到 2025 年其收入將達到 19 億美元至 20 億美元以上,我認為這表明了我們對該產品的堅定信心。
I'd like to remind everybody, there's still a huge unmet medical need of the 800,000 patients who suffer from tardive dyskinesia, only 6% are on treatment.
我想提醒大家,在80萬名遲發性運動障礙患者中,仍有龐大的醫療需求未被滿足,只有6%的患者正在接受治療。
So we see a long runway for this product.
因此,我們認為這款產品的前景十分光明。
Now moving on to UZEDY.
現在轉到 UZEDY。
UZEDY really pleased with what the team has done here.
UZEDY 對團隊在這裡所做的事情感到非常滿意。
I think it goes to show what a really good differentiated product we have and what a world-class team we have out in the field.
我認為這表明我們擁有真正優秀的差異化產品,並且我們在該領域擁有世界一流的團隊。
We did $117 million for the full year.
我們全年獲利 1.17 億美元。
So we beat our guidance of $100 million, and we're planning to do $160 million in 2025, so another growth contributor going into this year.
因此,我們超出了 1 億美元的預期,並計劃在 2025 年達到 1.6 億美元,因此今年將有另一個成長動力。
As we move on to AJOVY, I'm very proud of AJOVY.
當我們繼續討論 AJOVY 時,我對 AJOVY 感到非常自豪。
It's an interesting product and when I came here, I think people weren't sure what this could do going forward, but I think the company and the team have shown what they can do even in a very competitive market across all of our regions.
這是一款有趣的產品,當我來到這裡時,我想人們並不確定它在未來能做什麼,但我認為該公司和團隊已經展示了他們可以做什麼,即使在我們所有地區競爭非常激烈的市場中。
The 18% growth, I think, shows the ability for our teams, whether it's in Europe, USA or international markets, to take market share, and we've grown market share across all of our regions here.
我認為,18% 的成長率表明了我們的團隊有能力佔領市場份額,無論是在歐洲、美國還是國際市場,而且我們在所有地區的市場份額都有所增長。
So congratulations to the team.
我向這個團隊表示祝賀。
And because of that, we're giving guidance of $600 million for 2025.
正因為如此,我們給了 2025 年 6 億美元的指導價格。
So really good strong contribution from our innovative business and a good strong growth going forward into 2025.
因此,我們的創新業務確實做出了巨大貢獻,並且在 2025 年實現了強勁成長。
Now moving on to the second pillar, which is step up innovation, which Eric will go into a lot more detail, but I can't help talk about it because I'm so excited about it.
現在轉到第二個支柱,即加強創新,埃里克將會更詳細地講解,但我忍不住談論它,因為我對此感到非常興奮。
So if you look at our late-stage products here, olanzapine, ICS, SABA, DARI and duvakitug, these are all products which are coming to markets which have significant unmet medical need.
因此,如果您看看我們這裡的後期產品,奧氮平、ICS、SABA、DARI 和 duvakitug,這些都是進入具有重大未滿足醫療需求的市場的產品。
And we come in to the market in the near term.
我們將於近期進入市場。
Olanzapine will be in '26, ICS, SABA, DARI will be in '27 around about that, and duvakitug will be towards a year or two later.
奧氮平將於26年上市,ICS、SABA、DARI 將於27年左右上市,而杜瓦基圖格將於一兩年後上市。
So really excited about this, and we'll be entering the Phase III with duvakitug this year, and we'll be talking about some indications as well.
所以我們對此真的很興奮,今年我們將與 duvakitug 一起進入第三階段,我們也將討論一些適應症。
Now our early-stage pipeline is also exciting.
現在我們早期的管道也令人興奮。
I'd remind people that the anti-IL15 and the anti-PD1-IL2 were developed and created by the same team who created what we believe is best-in-class TL1A duvakitug.
我想提醒大家,抗 IL15 和抗 PD1-IL2 是由同一支團隊開發和創建的,該團隊還創建了我們認為一流的 TL1A duvakitug。
So very excited about this pipeline, and Eric will go into a bit more detail.
我對這個管道感到非常興奮,Eric 將會進行更詳細的介紹。
Now moving on to the third pillar, which is our greater sustainable generics powerhouse, starting with our biosimilars.
現在進入第三個支柱,這是我們更強大的永續仿製藥動力源,首先是我們的生物相似藥。
Our strategy was to build a broad portfolio, and we're up to 18 assets now, and you saw us do a couple of partnerships, a few partnerships last year to build out this portfolio even further.
我們的策略是建立廣泛的投資組合,現在我們已有 18 項資產,您看到我們去年進行了幾次合作,以進一步擴大這個投資組合。
But I think what is exciting to see is between now, this year, '25 and '27, we will launch seven assets into the United States, and we launched four buy-sell assets into Europe.
但我認為令人興奮的是,從今年(25 年至 27 年)之間,我們將在美國推出七項資產,並在歐洲推出四項買賣資產。
So this is really starting to build momentum and acceleration for our biosimilar business.
這確實開始為我們的生物相似藥業務積聚動力和加速。
And that will also help us drive growth on the top and bottom line towards our 2027 target.
這也將幫助我們推動營收和利潤的成長,朝著 2027 年的目標邁進。
Now going into the core generics business, another strong year, and as I said, across all regions.
現在進入核心仿製藥業務,又是強勁的一年,而且正如我所說,在所有地區都是如此。
And this was where we just started to tighten our capability and our focus operationally.
這正是我們開始加強我們的能力和營運重點的地方。
We've improved our ability to launch our new products across all regions on time more often.
我們提高了在所有地區按時推出新產品的能力。
We've improved our supply chain, making sure we can supply the market on time more often.
我們改進了供應鏈,確保能夠更頻繁地按時向市場供貨。
And we're also doing some work -- we did some work in '24, and this will continue to make sure we improve that efficiency within our supply chain so we can reduce our COGS and become even more competitive over the long term.
我們也正在做一些工作——我們在 24 年做了一些工作,這將繼續確保我們提高供應鏈中的效率,以便我們能夠降低 COGS 並在長期內變得更具競爭力。
But this generics business grew at 11%, so very strong.
但仿製藥業務成長了 11%,因此非常強勁。
Now let me give you a bit of detail on what the regions did.
現在讓我詳細介紹一下各地區所做的事情。
And I think all the regions stepped up to drive this 11%.
我認為所有地區都加大了推動力度,推動了這 11% 的成長。
Another year of strong growth by the US team.
這是美國團隊又強勁成長的一年。
So congratulations to them.
所以向他們表示祝賀。
And Europe, 6%.
歐洲佔6%。
As you know, this is a very big business.
如你所知,這是一筆很大的生意。
And we've seen mid-single-digit growth from Europe now consistently.
我們現在看到歐洲持續保持中等個位數的成長。
So another strong year for the team.
對球隊來說,今年又是強勁的一年。
And international markets at 15% consistently deliver double-digit growth.
國際市場則以15%的份額持續實現兩位數的成長。
Now moving on to the final pillar, which is focus the business, and this is where TAPI comes in.
現在轉到最後一個支柱,即專注於業務,這就是 TAPI 的作用所在。
I'm really pleased with the work the TAPI team have done.
我對 TAPI 團隊所做的工作非常滿意。
We've taken this business from decline to growth and the momentum is increasing, and we have confidence that we can continue this growth into mid to high single digits.
我們已經將這項業務從衰退轉為成長,並且勢頭還在增強,我們有信心能夠繼續保持中高個位數的成長。
The third-party business and the pipeline is growing significantly in 2024.
2024 年第三方業務和通路將大幅成長。
We continue to see that happen in '25 and we continue with the divestment process.
我們在25年繼續看到這種情況發生,並且我們繼續進行撤資程序。
Now talking about the fourth pillar, we always talk about capital allocation.
現在談到第四個支柱,我們總是談論資本配置。
We're very much focused on this at Teva.
在 Teva 我們非常關注這一點。
And just to remind everybody, as we generate more cash, more capital, we'll put that to paying down our debt.
需要提醒大家的是,當我們產生更多的現金和更多的資本時,我們將用它來償還債務。
That's the number one priority.
這是首要任務。
But then we'll invest in the growth engines.
但隨後我們將投資成長引擎。
As you see, we get a good return on that investment with AUSTEDO, AJOVY and UZEDY.
如您所見,我們透過 AUSTEDO、AJOVY 和 UZEDY 獲得了豐厚的投資回報。
And then with this exciting pipeline, Eric also will get the capital to make sure that we can maximize that obviously because some of this pipeline will have the opportunity to go into a number of indications.
然後,憑藉這個令人興奮的管道,埃里克還將獲得資本,以確保我們能夠最大限度地利用它,因為這個管道中的一些將有機會進入多個適應症。
And then we'll do -- we'll supplement all of this with business development.
然後我們會——我們會透過業務發展來補充所有這些。
So that's what we've done in '25 from a business point of view.
從商業角度來看,這就是我們在 25 年所做的事情。
Now I'll hand over to Eric, who's going to talk you through that pipeline that we're so excited about.
現在我將麥克風交給 Eric,他將向你們詳細講述令我們興奮不已的這條管道。
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Thank you, Richard.
謝謝你,理查。
I first wanted to start off by saying we were very excited by the announcement of our top line results for our duvakitug program last month.
首先我想說的是,我們對上個月宣布的 duvakitug 計畫的營收結果感到非常興奮。
The data speaks for itself, great dose response in both ulcerative colitis and Crohn's disease, and these treatment effects are the highest reported for this MOA.
數據不言而喻,潰瘍性結腸炎和克隆氏症都有很好的劑量反應,而這些治療效果是此類 MOA 所報告的最高效果。
So great work by the team, and we're very excited to show these results.
團隊做得非常出色,我們非常高興能展示這些成果。
This was a validation of what we've been saying about the fundamentals of this program.
這驗證了我們關於該計劃基本原則的論述。
Duvakitug has high potency in vitro, has high selectivity for the DR3 receptor, has low antidrug antibodies it shows a rapid profound and prolonged suppression of the free TL1A levels in the serum.
Duvakitug 具有體外高效力,對 DR3 受體有高選擇性,抗藥性抗體低,可快速、深入且長時間抑制血清中的遊離 TL1A 水平。
And we've consistently shown a favorable safety and tolerability profile to date.
到目前為止,我們一直表現出良好的安全性和耐受性。
So very excited by the data.
這些數據讓我非常興奮。
And we're very pleased that this will be presented as late breakers for both ulcerative colitis and Crohn's disease at the ECHO Conference on February 22nd in Berlin.
我們非常高興這將在 2 月 22 日於柏林舉行的 ECHO 會議上作為潰瘍性結腸炎和克隆氏症的最新突破性進展進行介紹。
So great work by the team.
團隊表現出色。
Now this next slide, I could also say it speaks for itself, but I don't want to say that today.
現在,這張投影片本身也說明了一切,但今天我不想這麼說。
I want to really walk through this because this is a very important slide when it comes to our duvakitug program.
我想要真正講解這一點,因為對於我們的 duvakitug 計劃來說,這是一張非常重要的幻燈片。
TL1A is produced by a variety of cells, mucosal cells and immune cells.
TL1A由多種細胞、黏膜細胞和免疫細胞產生。
And the stimulus for the release of free TL1A is both microbial and nonmicrobial signals.
而釋放遊離TL1A的刺激因子既有微生物訊號,也有非微生物訊號。
But TL1A acts as a key amplifying signal.
但TL1A起著關鍵的放大訊號的作用。
It binds to a variety of different cells in the immune system then to secrete a variety of different cytokines and trigger different signaling pathways.
它與免疫系統中的多種不同細胞結合,然後分泌多種不同的細胞因子並觸發不同的信號通路。
It also binds the fibrotic cells and has an impact on fibrosis and the maturation of fibrotic matrix.
它也與纖維化細胞結合並對纖維化和纖維化基質的成熟產生影響。
Now what does this mean?
那麼這是什麼意思呢?
Well, it means that you can envision many different indications that this program could go into from Crohn's disease all the way down to idiopathic pulmonary fibrosis.
嗯,這意味著你可以想像這個計畫可以治療許多不同的疾病,從克隆氏症一直到特發性肺纖維化。
And to really put this in context, we've listed a number of marketed products, as you all know very well.
為了更清楚地說明這一點,我們列出了許多市場上的產品,這大家都非常清楚。
We know the impact of all these programs and these products have on patients worldwide.
我們知道所有這些項目和產品對全世界患者的影響。
But it's important to remember, these programs and products only hit specific subsets of these signaling pathways.
但必須記住的是,這些程序和產品僅作用於這些訊號路徑的特定子集。
So it's really exciting to think about the prospect of what a compound like duvakitug could do when hitting this amplification signal of a variety of different cellular pathways.
因此,想像一下像 duvakitug 這樣的化合物在擊中各種不同細胞路徑的放大訊號時能夠產生什麼樣的效果,真是令人興奮。
So it's a -- it really is a portfolio and a product and the future, I believe, is very bright to the birth of this new class of MOA.
所以它 — — 它確實是一個投資組合和產品,我相信,對於這個新型 MOA 的誕生,未來是非常光明的。
Moving on to our dual action rescue inhaler program, very exciting program, very big program for Teva.
繼續我們的雙重作用救援吸入器計劃,對於 Teva 來說,這是一個非常令人興奮的計劃,也是一個非常重要的計劃。
It's important to remember, there's 11 million people in the US today who are still using a single albuterol, like SABA single agent for their asthma exacerbations.
重要的是要記住,目前美國有 1100 萬人仍在使用單一沙丁胺醇,如 SABA 單一藥物來治療氣喘發作。
So it's a large population.
因此,其人口數量很大。
But we already know that GENA guidelines actually recommend using a dual-action rescue inhaler.
但我們已經知道,GENA 指南實際上建議使用雙重作用救援吸入器。
You should be getting a beta agonist plus a steroid when you have an asthma exacerbation.
當您的氣喘病情惡化時,您應該服用β受體激動劑和類固醇。
So Teva is very proud to be bringing forward an easy-to-use dual-action rescue inhaled dry powder inhaler device.
因此,Teva 非常自豪地推出了一個易於使用的雙重作用救援吸入乾粉吸入器裝置。
And to give a little bit more color as to why the dry powder inhaler device is important is the difference between what's available now, a metered dose inhaler, which is the old in spray type inhaler device compared to our dry powder.
為了更清楚地說明乾粉吸入器裝置的重要性,我們將其與現在的定量吸入器進行了區分,與我們的乾粉吸入器相比,定量吸入器是一種老式的噴霧式吸入器裝置。
And differences our product doesn't require any priming.
不同之處在於我們的產品不需要任何底漆。
It doesn't require any shaking.
它不需要任何搖晃。
No hand breadth coordination is needed.
不需要手掌寬度協調。
No spacers are needed, and it's not complicated by cleaning.
不需要墊片,清潔也不複雜。
It's simply open and hail and close.
它只是打開、呼喊和關閉。
So it's an easy-to-use product, both by pediatrics and adults.
因此,無論對於兒科還是成人來說,它都是一種易於使用的產品。
And just to remind you what our Phase III program looks like it's a three-arm study.
只是為了提醒您我們的第三階段計劃看起來像是三組研究。
It's a large study of over 2,000 patients that we use two different doses compared to albuterol alone.
這是一項針對超過 2,000 名患者進行的大規模研究,我們使用了兩種不同的劑量與單獨使用沙丁胺醇進行比較。
It's exciting that we're including patients all the way down to the age of four through adulthood.
令人興奮的是,我們的患者範圍涵蓋從四歲到成年的各個年齡層。
It's a primary endpoint looking at asthma exacerbations and it's an event-driven study.
這是觀察氣喘惡化的主要終點,是一項事件驅動的研究。
So our focus this year is enrolling it.
因此我們今年的重點是招生。
We've got over 91% of our sites up and running at this point, and this is going to be a very big focus for us in R&D this year.
目前,我們的站點已有超過 91% 正常運行,這將是我們今年研發的重點。
And last but not least, our olanzapine LAI program is right on schedule.
最後同樣重要的一點是,我們的奧氮平 LAI 專案正在按計劃進行。
Our last patient last visit will be imminently at the end of this month.
我們的最後一次病人就診將在本月底進行。
We're looking to present the full safety database in the second quarter of this year at a conference and we're looking for the NDA submission in the second half of this year.
我們希望在今年第二季的會議上展示完整的安全資料庫,並希望在今年下半年提交 NDA。
Very excited about this program.
對這個項目感到非常興奮。
I think it's going to be an important product for patients with schizophrenia.
我認為這將成為精神分裂症患者的重要產品。
And last, I just wanted to point out and pause for a minute and say how far we've come in the innovative programs at Teva over the last two years.
最後,我想指出並停頓一下,說一下過去兩年來 Teva 在創新專案中取得的進展。
I'm proud to say that all these programs now have dosed or are dosing in all these different indications at this point.
我很自豪地說,目前所有這些項目都已經或正在針對所有這些不同的適應症實施。
As I mentioned, olanzapine LAI, we're looking for the submission this year after the presentation of the last data in the safety.
正如我所提到的,奧氮平 LAI,我們希望在安全性方面的最後一份數據提交後,在今年提交。
The DARI program, as I mentioned, is our biggest Phase III study to date at Teva, and we really got a good head start on our site initiations, duvakitug was a great end of the year presentation with the data, and we're excited to be working with Sanofi to get the Phase III started this year.
正如我所提到的,DARI 計畫是 Teva 迄今為止最大的 III 期研究,我們在網站啟動方面確實取得了良好的開端,duvakitug 是一份很棒的年底數據演示,我們很興奮與賽諾菲合作,今年啟動第三階段研究。
Emrusolmin is dosing a high unmet medical need for multiple system atrophy anti IL-15 is now in Celiac and vitiligo.
Emrusolmin 正在治療多種系統萎縮症,抗 IL-15 現已用於治療乳糜瀉和白斑,滿足尚未滿足的醫療需求。
And last but not least, we're now dosing patients in our anti-PD-1 IL-2 program in oncology.
最後但同樣重要的一點是,我們現在正在為腫瘤學中的抗 PD-1 IL-2 計畫患者提供用藥。
So it's been a great two years.
這是美好的兩年。
I want for more this year.
今年我想要更多。
And with that, I'm going to pass it off to Eli.
說完這些,我要把它交給 Eli。
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Thank you, Eric, and good morning and good afternoon to everyone.
謝謝你,艾瑞克,祝大家早安,下午好。
I will begin my review of our 2024 financial results, focusing on our fourth quarter performance.
我將開始回顧我們的 2024 年財務業績,並專注於第四季度的業績。
I will follow up on this one with the introduction of our non-GAAP outlook for 2025 and some of its important assumptions to help you to better understand our financial guidance for this year.
我將繼續介紹我們對 2025 年的非 GAAP 展望及其一些重要假設,以幫助您更好地了解我們今年的財務指導。
Beginning on slide 27.
從第 27 張投影片開始。
I would like to remind everyone that in the fourth quarter of 2023, Teva entered to exclusive collaboration with Sanofi to develop and commercialize Teva's anti-TL1A acids, duvakitug.
我想提醒大家,2023 年第四季度,Teva 與 Sanofi 達成獨家合作,開發和商業化 Teva 的抗 TL1A 酸 duvakitug。
As we communicated previously for the terms of the collaboration agreement, Teva received an upfront payment of $500 million in the fourth quarter of 2023, which we recognized as revenue.
正如我們之前就合作協議條款所傳達的那樣,Teva 在 2023 年第四季度收到了 5 億美元的預付款,我們將其確認為收入。
This payment positively contributed $500 million, both our revenue and free cash flow and had a positive contribution to our adjusted EBITDA of approximately $430 million.
這筆付款為我們的收入和自由現金流貢獻了 5 億美元,並對我們的調整後 EBITDA 產生了約 4.3 億美元的積極貢獻。
During the presentation, I will discuss certain results, including revenue, profits and free cash flow for the quarter and for the full year of 2024, excluding the impact of this upfront milestone payments in 2023 to also provide you a like-to-like comparison of our financial results.
在演示過程中,我將討論某些結果,包括本季度和 2024 年全年的收入、利潤和自由現金流,不包括 2023 年這筆里程碑式預付款的影響,以便為您提供同類比較我們的財務業績。
Now starting with our Q4 GAAP performance.
現在開始介紹我們的第四季 GAAP 業績。
Revenue in the fourth quarter of 2024 were $4.2 billion, a decrease of 5% in both US dollars and local currency terms compared to the fourth quarter of 2023.
2024年第四季的營收為42億美元,與2023年第四季相比,以美元和當地貨幣計算均下降了5%。
Excluding the Sanofi payment, revenue increased 7% in both US dollars and local currency terms compared to the fourth quarter of 2023.
不包括賽諾菲的付款,與 2023 年第四季相比,營收以美元和當地貨幣計算均成長了 7%。
This increase was mainly driven by strong growth from our key innovative products, AUSTEDO, UZEDY and AJOVY, growth from our generics products across all our segments globally as well as from sale of certain product rights.
這一成長主要得益於我們的主要創新產品 AUSTEDO、UZEDY 和 AJOVY 的強勁成長、我們全球所有部門的仿製藥產品的成長以及某些產品權利的銷售。
In Q4 2024, we recorded a GAAP operating loss of $29 million compared to a GAAP operating income of $755 million in the same quarter of last year.
2024 年第四季度,我們記錄的 GAAP 營業虧損為 2,900 萬美元,而去年同期的 GAAP 營業收入為 7.55 億美元。
The main driver of the decrease was the sum of the upward payment as well as a goodwill impairment charge in Q4 2024 related to our API reporting unit.
下降的主要原因是 2024 年第四季與我們的 API 報告部門相關的上行支付總額以及商譽減損費用。
Our GAAP net loss and net loss per share were $217 million and $0.19, respectively, which were primarily driven by the decline in operating income that I just explained.
我們的 GAAP 淨虧損和每股淨虧損分別為 2.17 億美元和 0.19 美元,這主要是由於我剛才解釋的營業收入下降所致。
Turning to slide 28.
翻到第 28 張投影片。
You can see that the total non-GAAP adjustment in the fourth quarter of 2024 were $1,033 million.
您可以看到,2024 年第四季的非 GAAP 調整總額為 10.33 億美元。
This included impairment of long-lived assets of $517 million, mainly related to the classification of our business ventures in the fund and our API business as a held for sale as well as the $280 million goodwill impairment charge also related to that same business.
其中包括 5.17 億美元的長期資產減值,主要與我們在基金中的業務投資和 API 業務歸類為持有待售有關,以及與同一業務相關的 2.8 億美元商譽減損費用。
Now moving to slide 29.
現在轉到第 29 張投影片。
We will review our non-GAAP performance.
我們將審查我們的非公認會計準則表現。
As I already mentioned, our fourth quarter revenue were approximately $4.2 billion.
正如我已經提到的,我們第四季的營收約為 42 億美元。
Our [indiscernible] revenue in 2024 were $16.5 billion an increase of 8% in US dollars and 9% in local currency terms compared to 2023, excluding the contribution from the Sanofi upfront payment.
2024 年,我們的 [聽不清楚] 營收為 165 億美元,與 2023 年相比,以美元計算成長 8%,以當地貨幣計算成長 9%,不包括賽諾菲預付款的貢獻。
Next, let's move down the P&L, starting with the gross profit margin.
接下來,讓我們來看看損益表,從毛利率開始。
Our non-GAAP gross profit margin was 54.8% compared to 58.2% in Q4 2023.
我們的非 GAAP 毛利率為 54.8%,而 2023 年第四季為 58.2%。
Excluding the upfront payment in 2023, our gross profit margins improved by approximately 150 basis points year-over-year.
除去2023年的預付款,我們的毛利率年增了約150個基點。
This improvement was driven by ongoing improvement in our portfolio mix mainly coming from AUSTEDO as well as the sale of certain product rights.
這項改善主要得益於我們投資組合的持續改善以及某些產品權利的出售。
As we have communicated previously, some of these legacy brands and generics product rights is in line with our strategy to constantly optimize our product portfolio with a focus on our long-term profitability.
正如我們之前所傳達的,其中一些傳統品牌和仿製藥產品權利符合我們的策略,即不斷優化我們的產品組合併專注於我們的長期盈利能力。
Overall, we saw a gradual and sustainable improvement in our gross profit margin.
整體而言,我們的毛利率呈現逐步、可持續的改善。
This was despite significant FX headwinds, which negatively impacted our revenue by approximately $257 million and a gross profit by $187 million, mainly as a result of a stronger US dollar against the currencies of certain of our international markets.
儘管面臨巨大的外匯逆風,我們的收入還是減少了約 2.57 億美元,毛利減少了 1.87 億美元,這主要是由於美元兌某些國際市場的貨幣走強。
Non-GAAP operating margin was 27.6% in Q4 2024, slightly below the fourth quarter of 2023, excluding the upfront payment last year, mainly due to higher operating expenses as a percentage of revenue, reflecting our deliberate investment in R&D and sales marketing to drive growth in both of our key innovative products as well as a further acceleration of our pipeline.
2024 年第四季的非GAAP 營業利潤率為27.6%,略低於2023 年第四季(不包括去年的預付款),這主要是由於營業費用佔收入的百分比較高,反映了我們對研發和銷售行銷的刻意投資,以推動我們的主要創新產品均實現了成長,並且我們的產品線也進一步加速。
Turning to EPS.
轉向 EPS。
We ended the quarter with a non-GAAP earnings per share of $0.71 compared to $0.69 in Q4 2023, excluding the upfront payment, mainly driven by higher absolute levels of operating income.
本季結束時,我們的非 GAAP 每股收益為 0.71 美元,而 2023 年第四季為 0.69 美元(不包括預付款),這主要得益於絕對營業收入水準的提高。
Now moving to slide 30.
現在轉到第 30 張投影片。
This slide highlights our focused and balanced approach to drive steady improvements in profit and cash flow as we continue to invest in our business for short- and long-term growth.
本投影片重點介紹了我們專注而均衡的方針,在我們繼續投資於業務以實現短期和長期成長的同時,推動利潤和現金流的穩定改善。
As I mentioned earlier, excluding the upfront payment last year, our gross profit and free cash flow improved in 2024, driven by our portfolio mix with a strong growth coming from our key innovative products.
正如我之前提到的,除去去年的預付款,我們的毛利和自由現金流在 2024 年有所改善,這得益於我們的投資組合,以及來自我們主要創新產品的強勁增長。
This allow us to reinvest a portion of that gross profit into the sales, marketing and R&D to support our growing innovative portfolio and progressing our key pipeline assets, leading to high operating expenses.
這使我們能夠將部分毛利重新投資於銷售、行銷和研發,以支持我們不斷增長的創新產品組合和推進我們的關鍵管道資產,從而導致高昂的營運費用。
We believe this balanced cost allocation is important for us in the short term to create a business with both long-term growth and profitability with a growth of a mix in higher-margin innovative portfolio.
我們相信,這種均衡的成本分配對於我們在短期內創造一個具有長期成長和獲利能力的業務以及高利潤創新投資組合的成長非常重要。
Our free cash flow in 2024 were just over $2 billion at the point -- at the end of the point of our guidance range, increasing by approximately 10% versus 2023, excluding the upfront payment from Sanofi, driven by higher net profit and our ongoing efforts to improve our working capital management, partially offset by higher legal payments.
2024 年,我們的自由現金流略高於20 億美元(在我們指引範圍的末端),較2023 年成長約10%,不包括賽諾菲的預付款,這得益於更高的淨利潤和我們持續的努力改善我們的營運資本管理,但部分被更高的法律支付所抵消。
As a reminder, our free cash flow in 2024 included $522 million litigation payments, which was increase of $57 million compared to 2023.
提醒一下,我們 2024 年的自由現金流包括 5.22 億美元的訴訟付款,比 2023 年增加了 5,700 萬美元。
These payments include settlement related to a legacy litigation that we have put behind us to focus on our growth strategy.
這些付款包括與遺留訴訟相關的和解金,我們已將該訴訟拋諸腦後,以專注於我們的成長策略。
Moving to the next slide.
移至下一張投影片。
I want to remind everyone of our commitment to continue to deleverage as we remain focused on executing the next phase of our Pivot to Growth journey.
我想提醒大家,我們致力於繼續去槓桿,同時我們仍將專注於執行「轉向成長」之旅的下一階段。
Throughout '24, we continue to reduce our net debt, which was approximately $14.5 billion at the end of the year.
在整個24年,我們繼續減少淨債務,截至年底約145億美元。
Gross debt was $17.8 billion compared to $19.8 billion at the end of 2023, mainly reflecting the repayment of approximately $1.6 billion of our senior notes at maturity.
總債務為 178 億美元,而 2023 年底為 198 億美元,主要反映了到期償還約 16 億美元的優先票據。
We also improved our net debt-to-EBITDA ratio, which is now approximately 3 times and on track to our 2027 targets of 2 times leverage.
我們也改善了淨負債與 EBITDA 比率,目前約為 3 倍,預計將實現 2027 年 2 倍槓桿率的目標。
As you can see on this slide, the execution of our Pivot to Growth strategy along with our disciplined capital allocation policy over the last several quarters has been recognized by the leading credit ratings agencies.
正如您在這張投影片上看到的,過去幾個季度中,我們「轉向成長」策略的執行以及嚴謹的資本配置政策得到了主要信用評級機構的認可。
All three major agencies have upgraded Teva credit ratings and outlook.
三大機構均上調了 Teva 的信用評級和展望。
In the last six months to reflect our improved growth prospects and continue strengthening our balance sheet.
在過去六個月中反映了我們改善的成長前景並繼續加強我們的資產負債表。
These upgrades are testament of our focused execution, and we remain committed to achieving an investment-grade rating in line to our 2027 financial targets.
這些升級證明了我們專注的執行力,我們仍然致力於實現符合 2027 年財務目標的投資等級。
Of the 70 global biopharma companies, rated by S&P, Teva is one of only two with a positive credit outlook.
在標準普爾評級的 70 家全球生物製藥公司中,Teva 是僅有的兩家信用前景良好的公司之一。
A positive outlook indicates that an issuer's credit metrics are expected to improve.
正面的前景顯示發行人的信用指標有望改善。
Now let's turn our attention to the 2025 non-GAAP outlook.
現在讓我們將注意力轉向 2025 年非 GAAP 展望。
As Richard and Eric talked about and as reflected in our financial results of 2024, that was a very strong year with our progress in our Pivot to Growth strategy.
正如理查德和埃里克所談到的,也反映在我們 2024 年的財務業績中,這是我們在「轉向成長」策略方面取得進展非常強勁的一年。
We delivered solid revenue growth, improved margin and cash flow and invested in our key growth drivers and our promising pipeline while navigating the impact of macro headwinds, such as foreign exchange movement.
我們實現了穩健的收入成長、利潤率和現金流提高,並在應對外匯變動等宏觀不利因素的影響的同時,投資於我們的關鍵成長動力和有前景的產品線。
As a reminder, in 2024, approximately 47% of our revenue were denominated in currencies other than US dollars.
提醒一下,2024 年,我們約有 47% 的收入以美元以外的貨幣計價。
In general, an increase in the US dollar versus other currencies in which we operated subjected to our hedging strategy has an impact on our revenue, profit and cash flow.
整體而言,根據我們的對沖策略,美元兌我們經營所涉及的其他貨幣的升值會對我們的收入、利潤和現金流產生影響。
In 2025, we remain focused on executing the next phase of our strategy.
2025年,我們將繼續專注於執行下一階段的策略。
We're also mindful of the industry dynamics, including the effect of the Inflation Reduction Act in the US markets, our financial guidance considering these evolving dynamics, as well as the headwinds from foreign exchange movements.
我們也關注產業動態,包括《通膨削減法案》對美國市場的影響、我們考慮到這些不斷變化的動態而製定的財務指導,以及外匯走勢帶來的阻力。
Now before I talk about the specific, I thought it will be helpful to lay out our financial guidance to make comparison as as simple as possible in light of the ongoing divestiture process of the Teva API in Japan generics business.
現在,在我談論具體情況之前,我認為,鑑於 Teva API 在日本仿製藥業務中的持續剝離過程,列出我們的財務指導將會很有幫助,以便盡可能簡單地進行比較。
The guidance range we are providing today assume a full year contribution from these assets in order to allow like-to-like comparison.
我們今天提供的指導範圍假設這些資產的全年貢獻,以便進行同類比較。
We plan on revisiting our guidance to include only their actual divestiture financial results upon closing.
我們計劃重新審視我們的指導方針,只包括交易完成時的實際資產剝離財務結果。
The guidance also excludes any contribution from potential development milestone payments from our partner, Sanofi, for the Phase III initiation of our anti-TL1A program, duvakitug.
該指引還不包括我們的合作夥伴賽諾菲為我們抗 TL1A 計畫 duvakitug 的第三階段啟動提供的任何潛在開發里程碑付款。
We will revise our guidance to include these milestone payments when they are earned.
我們將修改我們的指導方針,將這些里程碑付款納入其中。
With this in mind, we expect 2025 revenue of $16.8 billion to $17.4 billion.
考慮到這一點,我們預計 2025 年的營收將達到 168 億美元至 174 億美元。
This represents a growth of 2% to 5% compared to 2024, driven by the continued strong momentum in our innovative portfolio, including AUSTEDO, AJOVY and UZEDY along with the generics business that will grow, although more slowly than 2024.
與2024 年相比,這一數字將增長2% 至5%,這得益於我們創新產品組合持續強勁增長的勢頭,包括AUSTEDO、AJOVY 和UZEDY,以及仿製藥業務也將增長,儘管增長速度比2024 年要慢。
We expect gross margin in 2025 to be stable and consistent with 2024 level, approximately in the range of 53% to 54%.
我們預計 2025 年的毛利率將保持穩定並與 2024 年的水平一致,大約在 53% 至 54% 之間。
As I mentioned earlier, our gross margin in 2024 benefited partially from the sale of certain product rights consistent with our strategy -- in our innovative portfolio and the cost optimization program offsetting the adverse effects of the foreign exchange movements I just mentioned.
正如我之前提到的,我們2024 年的毛利率部分受益於出售符合我們策略的某些產品權利——在我們的創新產品組合和成本優化計劃中抵消了我剛才提到的外匯變動帶來的不利影響。
Coming to our non-GAAP operating profit.
談到我們的非公認會計準則營業利潤。
As I mentioned earlier, our focused investment in our key growth assets and our pipeline will continue consistent with our strategy to drive both the short and long-term growth of the company.
正如我之前提到的,我們對關鍵成長資產和產品線的重點投資將繼續符合我們推動公司短期和長期成長的策略。
With that in mind, we expect our operating expenses to be approximately 27% to 28% of revenue for the full year representing both higher R&D expenses and sales and marketing expenses compared to 2024.
考慮到這一點,我們預計全年營運費用將佔收入的約 27% 至 28%,與 2024 年相比,研發費用以及銷售和行銷費用都將增加。
As a result, our non-GAAP operating income is expected to be between $4.1 billion to $4.6 billion, and our non-GAAP adjusted EBITDA is expected to be between $4.5 billion and $5 billion, both consistent with the 2024 levels at the midpoint of our guidance range.
因此,我們的非 GAAP 營業收入預計在 41 億美元至 46 億美元之間,我們的非 GAAP 調整後 EBITDA 預計在 45 億美元至 50 億美元之間,均與我們 2024 年中期水準一致。 。
We expect finance expenses to be approximately $900 million in 2025, lower than 2024, reflecting a lower start of the year debt level and additional net reduction forecast over the course of 2025.
我們預計 2025 年的財務支出約為 9 億美元,低於 2024 年,這反映了年初債務水準較低以及 2025 年期間的額外淨減幅預測。
We expect our non-GAAP tax rate to be in the range of 15% to 18%.
我們預計非公認會計準則稅率在 15% 至 18% 之間。
This brings us we expected non-GAAP earnings per share in the range of $2.35 to $2.65.
這使我們預期非 GAAP 每股盈餘將在 2.35 美元至 2.65 美元之間。
We expect our 2024 free cash flow to be in the range of $1.6 billion to $1.9 billion.
我們預計 2024 年的自由現金流將在 16 億至 19 億美元之間。
This represented a slight decrease compared to 2024, mainly due to our deliberate efforts to streamline our accounts receivable securitization program as well as we take into account higher legal settlement outflows in 2025 aligned with what I mentioned earlier.
與 2024 年相比,這一數字略有下降,主要是因為我們刻意簡化了應收帳款證券化計劃,並且考慮到 2025 年的法律和解流出量將更高,與我之前提到的一致。
Lastly, as you know, we do not provide quarterly guidance, but I thought I would like to be helpful to provide you some insights regarding the expected quarterly progression.
最後,如您所知,我們不提供季度指導,但我認為我願意為您提供一些有關預期季度進展的見解。
Currently, with expected revenue, we are expecting gradually increased over the course of the year with the revenue in the second half of 2025, slightly higher than the first half.
目前,我們預期預期收入將在一年內逐步增加,2025 年下半年的營收將略高於上半年。
Our non-GAAP margin are also expected to gradually ramp up over the course of the year in line with the revenue trajectory as well as improvement in our cost optimization programs we have initiated.
我們的非公認會計準則利潤率預計也將隨著收入軌跡以及我們啟動的成本優化計劃的改善而在今年逐步上升。
With that, this concludes my review.
我的評論到此結束。
And now I will hand it back to Richard for a summary.
現在我將把會議紀錄交還給理查德,請他做總結。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thank you, Eli.
謝謝你,伊萊。
So to conclude, if we go to the next slide, please.
最後,請我們進入下一張投影片。
Thank you.
謝謝。
The journey of the Pivot to Growth continues.
轉向成長的旅程仍在繼續。
And in 2025, these are the things we're going to focus on with our four pillars.
到 2025 年,這些就是我們的四大支柱要重點關注的內容。
So for AUSTEDO, it's aiming towards this target we have of $1.9 billion to $2 billion.
因此對 AUSTEDO 來說,我們的目標是 19 億至 20 億美元。
UZEDY at $160 million and AJOVY over $600 million.
UZEDY 估值 1.6 億美元,AJOVY 估值超過 6 億美元。
So this is about driving these and delivering on these growth engines.
所以這是為了推動這些並實現這些成長引擎。
Step-up innovation, I think Eric's talked about that, getting the Phase III started is a clear focus and then finalizing indications.
加強創新,我認為艾瑞克已經談到了這一點,啟動第三階段是一個明確的重點,然後最終確定適應症。
Finally, in olanzapine and completing the pediatric recruitment for DARI or ICS/SABA.
最後,使用奧氮平並完成 DARI 或 ICS/SABA 的兒科招募。
So some really big milestones I think we have there for step-up innovation.
所以我認為我們在加強創新方面已經取得了一些真正重要的里程碑。
And then for the generics business, it's about making sure we continue to do the good work we started in '24, which is making sure we launch these complex generics that we have '16 over '24 -- say, '25 to '26 on time, making sure we launch our biosimilars that we have, the seven in the US and the four in Europe on time over '25 and '26, and then making sure we improve the efficiency of our business to make sure we have a good supply chain that's cost effective.
對於仿製藥業務,我們要確保繼續做好我們在 2024 年開始的工作,也就是確保我們在 2024 年到 2025 年期間推出這些複雜的仿製藥。年按時在美國推出7 種生物相似藥,在歐洲推出4 種生物相似藥,然後確保提高業務效率,確保我們有一個良好的具有成本效益的供應鏈。
And then on focus of the business, it's doing what Eli said and what I said earlier is making sure we're allocating capital to the right areas of business to drive short- and long-term growth of this company.
然後談到業務重點,我們要按照 Eli 和我之前說的做,確保我們將資金分配到正確的業務領域,以推動公司的短期和長期成長。
And then if I go on to the next slide, just to remind everybody, this Pivot to Growth is a journey.
然後,如果我繼續下一張投影片,只是為了提醒大家,這個「成長樞紐」是一段旅程。
We've sort of completed the first part, which was a return to growth.
我們已經完成了第一部分,即恢復成長。
And then it's all about making sure we can continue this growth and driving this through our innovative portfolio.
然後,一切都是為了確保我們能夠繼續這種成長,並透過我們的創新產品組合推動這一成長。
And I think we have really good reasons to stay very positive and optimistic because of the pipeline that's coming through now because the biosimilars that are coming through, the fact that we've returned our generics business to growth across all of our regions and the fact that we have plans to put in place to drive margin expansion.
我認為我們有充分的理由保持積極樂觀的態度,因為現在有各種各樣的生物仿製藥,我們的仿製藥業務在所有地區都恢復了增長,而且我們已製定計劃來提高利潤率。
From a portfolio point of view on the top line, but also from a cost of goods and efficiency point of view on the bottom line.
從投資組合的角度來看,這是營收情況,從商品成本和效率的角度來看,這也是營收。
So a lot of reasons to be optimistic about the future.
我們有很多理由對未來感到樂觀。
And with that, I'll close and hand it over to the group for questions, please.
現在,我的發言就結束了,請大家提問。
Operator
Operator
(Operator instructions)
(操作員指令)
[Jun Choy], Evercore ISI.
[Jun Choy],Evercore ISI。
Unidentified Participant
Unidentified Participant
This is Umer filling in for Jun Choy.
這是 Umer,代替 Jun Choy。
I had a couple of questions, if I may.
如果可以的話我有幾個問題。
First, maybe just big picture.
首先,可能只是整體情況。
As it relates to the EBITDA trajectory going forward, I know there's clearly investments that will be made on the TL1A program.
就其與未來的 EBITDA 發展軌跡而言,我知道顯然會對 TL1A 計劃進行投資。
Just curious how the spend will break out for Teva versus Sanofi as it relates to the new indications as well as as it relates to the Phase III program, but then also there's some AUSTEDO headwinds coming as well from an IRA perspective.
只是好奇 Teva 與 Sanofi 在新的適應症以及 III 期計劃方面的支出將如何展開,但從 IRA 的角度來看,AUSTEDO 也面臨一些阻力。
So how do you think about EBITDA trajectory going forward in general?
那麼,您整體上如何看待未來的 EBITDA 發展趨勢?
And secondly, on API business, I noticed in the reconciliation slide, there's some goodwill impairment as well as intangible impairment.
其次,關於 API 業務,我注意到在對帳幻燈片中,存在一些商譽減損以及無形減損。
Just trying to understand, have your expectations on API business pulled back in from a valuation perspective?
只是想了解一下,從估值角度來看,您對 API 業務的預期是否已經回落?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, Umer.
謝謝,烏默爾。
Thanks for the call.
感謝您的來電。
I think we'll tag team on this, I'll start with the bid and then Eli can chime in and then maybe even Eric a bit.
我想我們會在這件事上組成一個團隊,我先出價,然後 Eli 可以加入討論,然後也許 Eric 也可以加入討論。
So firstly, on the broader question of costs and EBITDA.
首先,關於成本和 EBITDA 的更廣泛問題。
Obviously, the partnership we have is about sharing both the upside and the cost to get there for duvakitug.
顯然,我們之間的合作是為了分享 duvakitug 實現這一目標所帶來的好處和成本。
So it will be a 50-50 share of the OpEx going forward.
因此,未來營運支出的份額將是50-50。
And obviously, I think your question relates to, as we move not only into Phase III for IBD, but what Eric talked about the multiple indications we're going to be thinking about going into.
顯然,我認為您的問題與我們不僅進入 IBD 的第三階段有關,而且與 Eric 談到的我們將要考慮進入的多種適應症有關。
I think from that point of view, it goes back to capital allocation and making sure we're focusing the capital on the right areas and duvakitug is definitely a priority.
我認為從這個角度來看,這又回到了資本配置的問題,並確保我們將資本集中在正確的領域,而 duvakitug 絕對是優先事項。
As we think about it, just generally over the course of the business to 2027, what Eli has also highlighted we have a lot of good things to invest in.
當我們思考這個問題時,總的來說,在到 2027 年的業務過程中,Eli 也強調我們有很多好的東西值得投資。
I think we've shown when we invest, we get a very good return as in the investments we did in our innovative portfolio in the market is steady, AJOVY and UZEDY have really delivered strong growth.
我認為我們已經證明,當我們進行投資時,我們會獲得非常好的回報,因為我們在市場創新投資組合中的投資是穩定的,AJOVY 和 UZEDY 確實實現了強勁的成長。
And also the investments we did in the pipeline have created real value creation in the short term, but definitely in the long term.
而且,我們在籌備中進行的投資在短期內創造了真正的價值,而且肯定在長期內創造價值。
So I think for us, we're aiming to grow our EBITDA.
因此我認為,對我們來說,我們的目標是提高我們的 EBITDA。
We want to grow obviously that '27 target, but we want to make sure we're investing in the short term to allow us to not really just hit the '27 target but to make sure we're really accelerating this business beyond that.
我們顯然想實現 27 年的目標,但我們希望確保我們在短期內進行投資,這樣我們不僅能夠真正實現 27 年的目標,而且能夠真正加速這項業務的發展。
Would you like to add anything else to that, Eric?
艾瑞克,你還有什麼要補充的嗎?
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
I think that the only thing I'd add is that the structure and the reason we did the deal with Sanofi, why it was so important, I mean it was a strategic way of making it possible to achieve the full potential of whether duvakitug program could achieve.
我認為我唯一要補充的是,我們與賽諾菲達成交易的結構和原因,以及它如此重要的原因,我的意思是,這是一種戰略方式,可以充分發揮 duvakitug 計劃的潛力可以實現。
And having a partner like Sanofi cost sharing is a really good way to have locked and loaded this for the future.
擁有像賽諾菲這樣的成本分攤合作夥伴確實是為未來做好充分準備的好方法。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
And then maybe with TAPI, Eli, do you want to take that?
然後也許是使用 TAPI,Eli,你想接受它嗎?
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Yes.
是的。
Umer, just on the spend to come back on the R&D.
Umer,剛才談到了將支出重新用於研發。
Just kind of high level, from '23 to '24 average, if you're looking about 45 to 55 generics innovative, we're looking now to kind of one-third and two-third in between the mix of generics and innovative in terms of how we're actually allocating costs into the R&D.
從 23 年到 24 年的平均值來看,如果你正在尋找大約 45 到 55 種仿製藥和創新藥,那麼我們現在正在尋找仿製藥和創新藥組合中的三分之一和三分之二。關於我們如何實際分配成本到研發中。
And yes, in '23, '24, we're an average like below 6%, you're going to be above 6% in R&D over revenue for the coming years, of course, also for '25.
是的,在 23 年和 24 年,我們的平均值低於 6%,但未來幾年,研發費用與收入之比將超過 6%,當然,在 25 年也是如此。
And as far as related to the API business on December 31, we classified the API business as a held for sale, and that actually including the three elements, which is R&D related to that business, the manufacturing and the commercial and into assets for sale, which classifies the net assets.
就12 月31 日的API 業務而言,我們將API 業務歸類為持有待售資產,這實際上包括三個要素,即與該業務相關的研發、製造和商業,並歸類為待售資產,將淨資產分類。
And before you do that kind of an element you need to kind of do kind of some analysis related to the expected deal structure and that for integrated kind of a Google assessment and after that in term of assets that those that you now collapsed into that classification.
在進行此類操作之前,您需要進行一些與預期交易結構相關的分析,然後進行綜合的 Google 評估,然後就資產而言,您現在將其歸入該分類。
We're not providing any information related to valuation because I mentioned it in the past, we really would like to respect the process, and working with our adviser on that perspective.
我們沒有提供任何與估值相關的信息,因為我過去提到過,我們真的想尊重這個過程,並從這個角度與我們的顧問合作。
But I will mention that pretty much nothing changed from what I said before in terms of the trajectory and the process on selling the API business.
但我要說的是,就出售 API 業務的軌跡和流程而言,與我之前所說的相比,幾乎沒有任何變化。
Operator
Operator
Jason Gerberry, Bank of America.
美國銀行的傑森·格貝利(Jason Gerberry)。
Jason Gerberry - Analyst
Jason Gerberry - Analyst
I just have a couple on the guide.
我的指南上只有幾條。
I'm just wanting to understand a little bit at your midpoint, you're growing sales, I think, $600 million, of which about $300 million of that is AUSTEDO, but yet there's like no operating leverage driving through the P&L.
我只是想了解你們的中間點,你們的銷售額正在成長,我想是 6 億美元,其中約 3 億美元是 AUSTEDO,但沒有任何經營槓桿推動損益表。
So maybe can you just help us understand that a little bit more?
那麼也許您能幫助我們進一步理解這一點嗎?
And then on UZEDY, in the second half of last year, you averaged -- I mean, you summed up to about $80 million in sales.
然後在 UZEDY,去年下半年,你們的平均銷售額達到了約 8,000 萬美元。
That's about $160 million run rate.
這相當於約 1.6 億美元的運行率。
So I'm just kind of curious, as we look to 2025, are you just being conservative on the outlook for that product?
所以我只是有點好奇,展望 2025 年,您對該產品的前景是否持保守態度?
Or are there some Part D redesign considerations that may impediment to growth?
或者 D 部分的某些重新設計考慮可能會阻礙成長?
So those are my questions.
這些都是我的問題。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, Jason.
謝謝,傑森。
Thanks for the questions.
感謝您的提問。
So I'll start in reverse.
因此我將從相反的方向開始。
So with regard to UZEDY, firstly, I'm glad you've noticed the strong performance of the team.
因此,關於 UZEDY,首先,我很高興您注意到了該團隊的強勁表現。
So thank you for that.
非常感謝你。
It was a good year in 2024.
2024年是好的一年。
I do just want to point out that UZEDY does fall into now the Medicare Part D redesign immediately.
我只是想指出 UZEDY 現在確實屬於 Medicare Part D 的重新設計。
And so we take that hit straightaway on Jan 1.
因此我們在 1 月 1 日就直接承受了這一打擊。
So that's the thing that I think may be the disconnect.
所以我認為這可能是脫節的原因。
We still see the opportunity to drive strong growth of the product from a prescription point of view, but we have to let that play out.
從處方角度來看,我們仍然看到推動產品強勁成長的機會,但我們必須讓這種機會發揮作用。
And then from an OP guide, which I think was a bit similar to the question that was prior, but I think a bit more detail you want.
然後來自 OP 指南,我認為這與之前的問題有點相似,但我認為你想要更詳細一點。
I think what we have also in -- and I'll start this and Eli then you can chime in.
我認為我們也有 — — 我會開始這個,然後 Eli 你也可以加入進來。
We have a few things.
我們有幾件事。
Firstly, this IRA redesign doesn't just touch UZEDY actually hit AUSTEDO, now AJOVY got the phase in with AUSTEDO, it still hits us.
首先,這次 IRA 重新設計不僅影響 UZEDY,實際上還影響了 AUSTEDO,現在 AJOVY 也與 AUSTEDO 一起進入了新階段,它仍然對我們產生影響。
And I think that's just something for people to start to understand.
我認為這只是人們開始理解的事情。
And obviously, AUSTEDO is a big product now because of the success, once again, that was driven by the team in 2024.
顯然,AUSTEDO 現在已經成為一款大產品,這再次歸功於團隊在 2024 年的成功。
So that's part of it.
這就是其中的一部分。
We do have our legacy innovative plans still declining.
我們遺留的創新計畫確實仍在下滑。
And then we have a big FX here as well.
這裡我們還有一個很大的 FX。
So I think those are the things that sort of contribute a bit to that.
所以我認為這些因素對此有所貢獻。
And then the thing we -- Eli highlighted around we are probably going to be investing a bit more to make sure the opportunities we got in front of us, which I think everybody sees are really clear.
然後我們——Eli 強調說,我們可能會投入更多一點來確保我們面前的機會,我想每個人都看得很清楚。
We don't not invest enough in those to make sure we can create the long-term success that we planned in Pivot to Growth.
我們在這些方面的投資還不夠,無法確保我們能夠創造「轉向成長」計畫中所規劃的長期成功。
But maybe, Eli, I'll let you add to that.
但也許,伊萊,我會讓你補充這一點。
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Yeah.
是的。
Jason, thanks for the question.
傑森,謝謝你的提問。
Just to kind of level set, right, if we end up the year with 50.3% on gross margin, if you actually back out the impact of $190 million on FX.
只是為了達到某種水平,對吧,如果我們今年的毛利率達到 50.3%,如果你真的撤消 1.9 億美元外匯的影響。
This company is running 54.5% I know the market is now looking on more or less the same gross margin, but we are -- from the fact that we have -- the majority part of our revenue is non-dominated US dollars with the FX fluctuation in what we saw in the last few months, mostly on euro dollars.
這家公司的毛利率為 54.5%,我知道市場現在的毛利率大致相同,但我們——從我們的事實來看——我們的大部分收入都是非主導美元,外匯我們在過去幾個月看到的波動,主要是歐元美元的波動。
We actually remain focused on how to guide and we're actually baking in some impact on FX.
我們實際上仍然專注於如何引導,我們實際上正在對 FX 產生一些影響。
And this is why you see kind of the guidance with 53% to 54%.
這就是為什麼你會看到 53% 到 54% 的指導比例。
And on top of what Richard mentioned, we will see some acceleration on cost, as we mentioned, in terms of R&D and a few other elements related to that one.
除了理查德提到的之外,我們還會看到成本加速,就像我們所提到的,包括研發和其他一些相關因素。
But as a percentage of revenue, we are actually improving and our investment in our OpEx.
但作為收入的百分比,我們實際上正在改善對營運支出的投資。
And therefore, we don't see a much flow through to the EBITDA just because of the fact that we're able to grow the business, and we're able to show it in the last two years.
因此,我們並沒有看到 EBITDA 有太大的變化,因為我們能夠發展業務,並且我們能夠在過去兩年中展示這一點。
Operator
Operator
David Amsellem, Piper Sandler.
大衛·阿姆塞勒姆,派珀·桑德勒。
David Amsellem - Analyst
David Amsellem - Analyst
So I know you're getting a lot of questions on Revlimid and what the business looks like in '26 with Revlimid eroding.
所以我知道你對 Revlimid 有很多疑問,以及隨著 Revlimid 的衰退,26 年的業務前景如何。
But can you just give us a more detailed road map on how you're thinking about newer products that could make up for the impact of losing sales on Revlimid?
但您能否向我們提供更詳細的路線圖,說明您如何考慮推出新產品,以彌補 Revlimid 銷售損失的影響?
Is it going to be mostly biosimilars weighted or complex small molecule weighted.
它主要是生物相似藥加權還是複雜小分子加權。
Can you just talk about what specific products and what kind of products do you think are going to make up for that shortfall for next year?
您能否談談哪些具體產品和哪種產品您認為可以彌補明年的缺口?
And then secondly, I know you probably can't give too much in the way of detail on this, but regarding the lawsuit versus CMS, any color on just sort of timing for arguments and how we should think about next steps there?
其次,我知道您可能無法就此提供太多細節,但關於對 CMS 的訴訟,您能具體說明辯論的時間安排以及我們應該如何考慮下一步嗎?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, David.
謝謝,大衛。
Thanks for the questions.
感謝您的提問。
So on the Revlimid, yeah, let me see if I can answer that to your satisfaction.
關於 Revlimid,是的,讓我看看我是否可以回答您這個問題來讓您滿意。
So once again, great performance that we we've seen by the team in the US to drive the success of Revlimid, but that does create a headwind potentially in the future, if not too careful.
因此,我們再次看到美國團隊的出色表現推動了 Revlimid 的成功,但如果不太小心,這確實可能在未來帶來阻力。
So how do we deal with that?
那我們該如何應對呢?
So firstly, I sort of want to take it to a macro level.
所以首先,我想將其帶到宏觀層面。
So firstly, because of the way the company is structured now and the growth rates we have in our innovative business and our ex US business, I think, from an overall growth rate of the company, I think we're in a position to weather the, if you want to call it, loss of exclusivity, which sounds a bit strange with the generics, but that cliff than we ever would in the past.
首先,考慮到公司目前的結構以及創新業務和美國以外業務的成長率,我認為,從公司的整體成長率來看,我們有能力承受如果你想稱之為失去排他性,這對於仿製藥來說聽起來有點奇怪,但這個懸崖比我們過去遇到的任何時候都要嚴重。
So I think that's important.
所以我認為這很重要。
But if you break it down a bit more specifically because I think that's where your question was, from a generics business, remember that two-third of our business is not in generics.
但如果你更具體地分解一下,因為我認為這就是你的問題,從仿製藥業務來看,請記住我們三分之二的業務不是仿製藥。
And as you saw, that's growing very strongly, and that's very profitable.
正如您所看到的,它的成長非常強勁,而且利潤豐厚。
So that's something that balances it.
所以這是一種平衡的方法。
Then going in clicking double clicking to go deeper into the US, which is, I think, specifically where your question is, we have 16 complex generic launches that we're going to do in '25 and '26.
然後點擊雙擊深入美國,我想,具體到你的問題所在,我們有 16 個複雜的通用產品發布,將在 25 年和 26 年進行。
So one of the things we have to do is maximize those and launch those on time and maximize those.
因此,我們必須要做的事情之一就是最大限度地發揮這些潛力,並按時推出這些潛力。
The other is we have a number of biosimilars that are coming out in '25 and some in '26 in the US, and so we need to maximize those as well as we've had some biosimilars that have launched slowly in the market, but we see those as an opportunity to contribute in '26.
另一個原因是,我們在美國有許多生物相似藥將在2025 年上市,還有一些將在2026 年上市,因此我們需要最大限度地利用這些生物仿製藥,因為我們有一些生物仿製藥在市場上推出得很慢,但我們將這些視為在26年做出貢獻的機會。
So you have all of those things going together.
所以你將所有這些事情結合在一起。
And our aim and our ambition is to manage that drop off, which, by the way, we plan for being a cliff, so we haven't anticipated any soft landing.
我們的目標和抱負是管理這種下降,順便說一句,我們計劃將其設計成懸崖,所以我們沒有預期任何軟著陸。
That's how we plan to deal with it.
我們計劃就這樣處理。
And if I take it right back to the beginning again, but on a macro level, don't forget we have AUSTEDO accelerating.
如果我再次回到開始,但從宏觀層面來看,不要忘記我們有 AUSTEDO 正在加速。
We have UZEDY accelerating.
我們有 UZEDY 正在加速。
We have AJOVY accelerating, we have olanzapine launched in '26.
我們有 AJOVY 加速研發,我們已於 26 年推出奧氮平。
We'll have ICS/SABA not far behind that.
緊跟在後,我們也會推出 ICS/SABA。
And so we have a lot of things to continue the trajectory of growth.
因此,我們還有很多事情要做,以延續成長的軌跡。
And I know the focus will be on '26, and we'll look to manage that as best we can.
我知道重點將放在 26 年,我們將盡最大努力實現這一目標。
But if you look at '27, '28 and beyond, I think the direction of travel for the revenue and the bottom line is clear based on all of those assets we have coming through.
但如果你展望27年、28年及以後,我認為,基於我們所擁有的所有資產,收入和底線的發展方向是明確的。
But I hope that helped, David.
但我希望這能有所幫助,大衛。
David Amsellem - Analyst
David Amsellem - Analyst
Yeah, that's helpful.
是的,這很有幫助。
And then CMS lawsuit question?
然後是 CMS 訴訟問題?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Sorry.
對不起。
Forget about that lawsuit.
忘掉那起訴訟吧。
So yes, so you're right.
是的,你是對的。
Unfortunately, I can't say too much about it because obviously, we're in litigation.
不幸的是,我不能說太多,因為顯然我們正在訴訟中。
But I think -- so as we get more clarity on that, we'll let you know from a timing point of view, we may have something that we can talk about later in the year.
但我認為——當我們對此有了更多的了解時,我們會從時間的角度告訴你,我們可能會在今年晚些時候談論一些事情。
But obviously, this is not something where we're necessarily in control of the time-lines.
但顯然,這並不是我們能夠控制時間軸的事情。
Operator
Operator
Balaji Prasad, Barclays.
巴克萊銀行的巴拉吉‧普拉薩德 (Balaji Prasad)。
Balaji Prasad - Analyst
Balaji Prasad - Analyst
A couple from me for Eli and Richard.
我為 Eli 和 Richard 獻上幾張。
Firstly, on the free cash flow decline this year in guidance, nearly $200 million to $500 million of decline.
首先,預計今年自由現金流將下降近 2 億至 5 億美元。
Can you quantify the impact of the accounts receivable securitization programs?
你能量化應收帳款證券化計畫的影響嗎?
Is this a one-off?
這是一次性的嗎?
Or is this purely a timing issue?
或者這純粹是時間問題?
And should we expect a normalized curve into 2026?
我們是否應該預期 2026 年的曲線將趨於正常化?
That's one.
那是一個。
And two, growing further on the EBITDA guidance.
二是進一步實現 EBITDA 預期成長。
I'm trying to understand if we set aside generic impact, is there any reason to think that the complex generics and biosimilars segment will be dilutive to EBITDA related to their own profitability in 2024 with the new launches coming in?
我想了解的是,如果我們拋開仿製藥的影響,是否有理由認為,隨著新產品的推出,複雜的仿製藥和生物仿製藥部門將在 2024 年稀釋與其自身盈利能力相關的 EBITDA?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, Balaji.
謝謝,巴拉吉。
Good to hear you.
很高興聽到你的消息。
I'll hand over the free cash flow to Eli, who can explain that.
我會將自由現金流交給 Eli,他可以解釋這一點。
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Yeah.
是的。
So Balaji, we were very transparent, and we mentioned that we are looking to reduce the program on the securitization.
所以 Balaji,我們非常透明,我們提到我們正在尋求減少證券化計劃。
To quantify the numbers, it's between $100 million to $200 million.
如果量化這個數字的話,那就是 1 億到 2 億美元之間。
Of course, it depends on the mix of the receivable as we move forward with the year in terms of timing, but that's kind of the element.
當然,這取決於我們隨著時間的推移應收帳款的組合情況,但這也是一個因素。
And of course, as I mentioned in my prepared remarks, we're going to have kind of a legacy of settlements payments that actually get kind of a timing now in '25 versus '24.
當然,正如我在準備好的演講中提到的那樣,我們將獲得一系列和解付款,這些付款實際上是在 2025 年而不是 2024 年之間確定的。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Eli, then do you want to take a bit of the EBITDA guidance?
Eli,那你想了解 EBITDA 指引嗎?
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Yeah.
是的。
So -- so our EBITDA, let's say, our guidance on the top level is including growth in generics and including growth in biosimilars, right, which mean is actually contributing to our margin with flow through to the EBITDA.
所以 - 所以我們的 EBITDA,比方說,我們對最高層的指導包括仿製藥的增長和生物仿製藥的增長,對吧,這意味著它實際上通過流入 EBITDA 來貢獻我們的利潤率。
We just need to remember that, as I mentioned, if you look actually on the higher range, of the revenue and the higher range of the OP, which is resulting with a higher EBITDA.
我們只需要記住,正如我所提到的那樣,如果你實際上看一下收入的較高範圍和 OP 的較高範圍,這將導致更高的 EBITDA。
You can see that we're actually around the 27.5% OpEx.
您可以看到我們的營運支出實際上約為 27.5%。
If you go to the midpoint, we kind of above the 28%.
如果你去中間點,我們就會略高於 28%。
And the reason for that one is because of the mix of the revenue and the contribution from the top line to the bottom line, which means for growing from the midpoint to the higher point, we are not actually spending more on OpEx, and this is just about how we view the element in the mix in terms of FX and our ability to grow mostly on the innovative part.
原因在於收入和從頂線到底線的貢獻的混合,這意味著從中間點增長到更高點,我們實際上並沒有在營運支出上花費更多,這是只是關於我們如何從外匯角度看待組合中的元素,以及我們主要在創新部分成長的能力。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Yeah.
是的。
And I think the thing I'd add to that, Eli, and it's important because I think we've been very focused on how we allocate capital within Teva to drive what has been a significant turnaround at this company in two years.
我想補充的是,Eli,這很重要,因為我認為我們一直非常關注如何在 Teva 內部分配資本,以推動該公司在兩年內實現重大轉變。
We've been able to actually drive the top line while managing the bottom line.
我們實際上能夠在管理利潤的同時推動營收成長。
But it's worth noting that the tremendous growth we've seen over eight quarters, the change in direction of AUSTEDO our innovative products and our pipeline is creating significant value, I think, going forward in the short and midterm definitely long term.
但值得注意的是,我們在八個季度中看到的巨大增長,AUSTEDO、我們的創新產品和產品線的方向的變化正在創造巨大的價值,我認為,這在短期、中期和長期內都具有重要意義。
And I think we've got to be good custodians of our capital to make sure we are driving these opportunities because these opportunities, I think we've shown over the last two years, do create significant value for the company and for the shareholders.
我認為我們必須妥善保管我們的資本,以確保我們能夠抓住這些機會,因為我認為我們在過去兩年中已經證明,這些機會確實為公司和股東創造了巨大的價值。
So that's one of the things we're always trying to do and manage and hopefully you've seen us do that.
這是我們一直嘗試去做和管理的事情之一,希望您已經看到我們做到了這一點。
Thanks for the question, Balaji.
謝謝你的提問,巴拉吉。
Operator
Operator
Ash Verma, UBS.
瑞銀的 Ash Verma。
Ash Verma - Analyst
Ash Verma - Analyst
I wanted to go back to the operating margin guidance one more time.
我想再回顧一下營業利潤率指引。
So this year, you're seeing 100 bps margin compression, which is in the opposite direction compared to where you're trying to get to to 30% by 2027.
因此,今年,您會看到利潤率壓縮了 100 個基點,這與您試圖在 2027 年達到 30% 的目標相比是相反的。
So are you still confident in the long-term outlook given that you will have more headwinds like Revlimid step down in 2026 and AUSTEDO IRA impact in 2027?
那麼,考慮到您將面臨更多阻力,例如 2026 年 Revlimid 停產和 2027 年 AUSTEDO IRA 的影響,您是否仍然對長期前景充滿信心?
And then I have a follow-up that I'll come back to.
然後我會回來繼續後續工作。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Okay.
好的。
Good to hear you, Ash.
很高興聽到你的消息,Ash。
So yeah, in short yes, absolutely.
是的,簡而言之,絕對是的。
And it comes down to primarily our innovative portfolio.
這主要歸功於我們的創新產品組合。
And let me explain.
讓我解釋一下。
So as you've seen the momentum we have with our innovative portfolio is clear, and that's going to keep driving the top line, but it changes our gross margin significantly, which just flows down through the P&L.
因此,正如您所看到的,我們創新產品組合的勢頭非常明顯,這將繼續推動營收成長,但它會顯著改變我們的毛利率,而毛利率會透過損益表向下流動。
So the biggest thing we do is we improve our portfolio mix.
因此,我們所做的最重要的事情就是改善我們的投資組合。
And I think people -- when we think about how the sales of this company are going to be made up in '27 versus now, they'll be very different.
我認為,當我們思考這家公司 27 年的銷售額與現在的銷售額相比時,情況會有很大不同。
There'll be a lot of innovative sales there, so that drives a very different trajectory.
那裡將會有大量的創新銷售,因此這將推動一條非常不同的軌跡。
And I am very confident about AUSTEDO.
我對AUSTEDO非常有信心。
And I remind everybody, despite the great growth 34% growth, 34% TRx growth, is only 6% of the 800 patients -- 800,000 patients who tardive dyskinesia on treatment.
我提醒大家,儘管 TRx 的成長速度很快(34%),但這只是 800 名接受治療的遲發性運動障礙患者(80 萬名)的 6%。
And I'll remind people that we are confident we're going to hit the $2.5 billion in '27, but the $2.5 billion is not the peak sales of AUSTEDO.
我要提醒大家,我們有信心在27年達到25億美元的銷售額,但25億美元並不是AUSTEDO的銷售高峰。
And so this is primarily driven by revenue.
所以這主要由收入驅動。
But then we have other factors going to be contributing to the EBITDA, which is we have put together a value acceleration program in our TGO cost base, which is huge to improve our efficiency within tech ops, and that will drive improvement in our gross margin for our generics business, which is still significant as well as improvement in our bottom line.
但是,我們還有其他因素會影響 EBITDA,即我們在 TGO 成本基礎上製定了一項價值加速計劃,這對於提高我們的技術運營效率非常重要,並將推動我們毛利率的提高對於我們的仿製藥業務來說,這仍然具有重要意義,並且對我們的盈利也有所改善。
And so those things, coupled with the fact that we'll be launching also more new product launches and biosimilars, which drive growth, which, once again, I think when we looked at '27 back in '23, and I remember you were there at that meeting, there was a lot of pessimism as to whether we could grow this generics business and whether we could actually bring the biosimilars to the market, I think we've shown we can.
因此,這些因素,再加上我們將推出更多新產品和生物仿製藥,將推動成長。能否發展仿製藥業務以及是否能真正將生物仿製藥推向市場持悲觀態度,但我認為我們已經證明我們可以。
So those are the factors why we believe we will hit the 30%.
這些就是我們相信能夠達到 30% 目標的因素。
So it is a bit of a hockey stick.
因此它有點像曲棍球棒。
I think I've been consistent in saying it is going to be a hockey stick, but it's based on some good fundamentals of growth on the top line, supported by thoughtful capital allocation and efficiencies we're driving through the business.
我想我一直在說這將會是一根曲棍球棒,但它基於一些良好的營收成長基本面,並得到了深思熟慮的資本配置和我們在整個業務中推動的效率的支持。
Is there anything you want to add to that, Eli?
您還有什麼要補充的嗎,Eli?
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
No.
不。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Okay.
好的。
So maybe a second question, Ash.
所以也許還有第二個問題,Ash。
Ash Verma - Analyst
Ash Verma - Analyst
Yeah, just on the TL1A, so just looking at these ECHO conference abstract.
是的,就在 TL1A 上,所以只看這些 ECHO 會議摘要。
So it seems like the 900 mg dose as opposed to the 450 is the one that is pretty convincingly beating the placebo, both in the naive and biologics experienced patients.
因此,看起來 900 毫克劑量(而非 450 毫克劑量)非常有說服力地優於安慰劑,無論對於未曾使用過生物製劑的患者還是使用過生物製劑的患者而言都是如此。
So higher dose seems pretty much very good here.
因此,較高的劑量似乎非常好。
So what I wanted to ask was like -- what was the rationale for you to discontinue your third dose earlier, which was the highest?
所以我想問的是——您提前停止服用第三劑(劑量最大)的理由是什麼?
And is there any potential to bring that back?
有沒有可能將其恢復呢?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Yeah.
是的。
Thanks for the question.
謝謝你的提問。
So yes, we're excited to be presenting the duvakitug data at the ECHO conference.
所以是的,我們很高興能夠在 ECHO 會議上展示 duvakitug 數據。
And when it comes to the dose response, it's always good in a dose-ranging Phase II study to have a dose response that really makes the modeling and simulation of your dose going forward much more robust.
當涉及劑量反應時,在劑量範圍 II 期研究中,最好有一個劑量反應,這確實使得未來劑量的建模和模擬更加穩健。
So we're in the middle of doing that work right now with our partner, Sanofi.
因此,我們現在正與合作夥伴賽諾菲合作這項工作。
We removed that dose early on because our biomarkers, as you can see across our program that we really do suppress the free TL1A very well at all the doses we've been looking at.
我們很早就取消了該劑量,因為我們的生物標誌物,正如您在整個計劃中看到的那樣,在我們研究的所有劑量下,我們確實能很好地抑制遊離 TL1A。
One of the other reasons we removed that a higher dose is because we wanted to actually have more power in these arms.
我們取消較高劑量的另一個原因是我們希望這些藥物實際上具有更強的功效。
And I think that was a really good decision because it gave us a great data set for both the ulcerative colitis and the Crohn's disease.
我認為這是一個非常好的決定,因為它為我們提供了大量有關潰瘍性結腸炎和克隆氏症的數據集。
Remember, this is the first well-controlled blinded study for Crohn's disease of this MOA.
請記住,這是針對該 MOA 的克隆氏症的第一個控制良好的盲法研究。
So the data is robust.
因此數據是可靠的。
The way that we redesigned the study is actually good.
我們重新設計研究的方式其實是好的。
And we'll see what the modeling and simulation is.
我們將看到建模和模擬是什麼。
But it's nice to see that we have this very safe, high therapeutic index right now, and we have a lot of places we can go with it.
但很高興看到,我們現在擁有這種非常安全、治療指數高的藥物,而且我們可以在很多地方使用它。
Operator
Operator
Yifeng Liu, HSBC.
劉逸峰,匯豐銀行。
Yifeng Liu - Analyst
Yifeng Liu - Analyst
I've got two, please.
請給我兩個。
Just one on capital allocation.
僅就資本配置而言。
You talked about business development opportunities, given that you are already quite establishing neuroscience and potentially in the future immunology, are there any other therapeutic areas or spaces you interested in branching out?
您談到了業務發展機會,鑑於您已經在神經科學領域建立了相當的影響力,並且可能在未來的免疫學領域有所建樹,您是否有興趣拓展其他治療領域或空間?
And the second question is on duvakitug.
第二個問題是關於duvakitug的。
And just wondered if you could share any other colors that you could on the upcoming Phase III development plan?
我只是想知道您是否可以分享即將到來的第三階段開發計劃的其他顏色?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks for the question.
謝謝你的提問。
So the capital allocation business development, other TAs.
因此,資本配置業務發展,其他TA。
So firstly, immunology and neurology or CNS offers a huge variety of diseases, conditions and indications.
首先,免疫學和神經病學或中樞神經系統涉及各種各樣的疾病、病症和適應症。
So I think that's a pretty big playing field.
所以我認為這是一個相當大的競爭環境。
But where we -- a couple of things to think about is we believe we have a CNS capability and infrastructure that we want to leverage, both from an R&D and a commercial capability.
但我們需要考慮的幾件事是,我們相信我們擁有 CNS 能力和基礎設施,我們希望利用這些能力和基礎設施,無論是從研發還是商業能力。
So we're really focused on that.
所以我們非常關注這一點。
Immunology, yes, -- that said, as Eric has talked about with duvakitug having multiple indications and also one of our other products in the pipeline IL-15 have multiple indications.
是的,免疫學——正如 Eric 所說,duvakitug 具有多種適應症,而我們正在研發的另一種產品 IL-15 也有多種適應症。
We feel we have a lot of immunology and we're already in our pipeline, which I don't think people necessarily fully appreciate.
我們覺得我們在免疫學方面有很多研究,而且我們已經在進行研究了,但我認為人們不一定完全認識到這一點。
But we still look there.
但我們仍然在尋找。
And then outside of that, we do believe that rare disease, it creates an opportunity for Teva.
除此之外,我們確實相信罕見疾病為 Teva 創造了機會。
Now that would primarily be once again, if possible, aligned to our therapeutic areas of CNS and immunology, which there is a large potential out there.
現在,如果可能的話,這將主要再次與我們的中樞神經系統和免疫學治療領域保持一致,該領域具有巨大的潛力。
So that's how we think about business development.
這就是我們對業務發展的看法。
And on duvakitug, I'll hand that over to Eric.
至於 duvakitug,我會把它交給 Eric。
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Thank you, Rich, and thanks for the question.
謝謝你,Rich,謝謝你的提問。
Yes.
是的。
So we're focused on the Phase III program with our partner, Sanofi.
因此,我們與合作夥伴賽諾菲一起專注於第三階段計劃。
We're working diligently.
我們正在努力工作。
The pathway forward is fortunately, clear in this disease area.
幸運的是,這一疾病領域的前進道路是清晰的。
We know what the endpoints should be.
我們知道終點應該是什麼。
We know what the requirements are and we are going to be consistent with what the FDA guidance is.
我們知道要求是什麼,我們將遵循 FDA 的指導。
So that's one of the great things about these disease areas.
這是這些疾病領域的一大優點。
What we have to do is clear.
我們該做的事情很明確。
Right now, we just have to put the final touches on our plan for the Phase III study design itself, which is really based on the modeling and simulation that we'll use from this first study.
現在,我們只需要對第三階段研究設計計劃進行最後的潤色,該計劃實際上是基於我們在第一項研究中使用的建模和模擬。
Beyond that, I think that we're excited about other indications in the future.
除此之外,我認為我們對未來的其他跡象感到興奮。
We're thinking about that very hard.
我們正在認真思考這個問題。
We're keeping it close to our chest.
我們對此守口如瓶。
But I think I want to focus back on that slide about the potential of what duvakitug could bring to patients in a very broad way with many different indications.
但我想我將焦點重新集中在那張投影片上,關於 duvakitug 可以以非常廣泛的方式為患者帶來的多種不同適應症的潛力。
That's going to be the exciting next step.
這將是令人興奮的下一步。
But thanks for the interest.
但感謝您的關注。
Operator
Operator
Glen Santangelo, Jefferies.
傑富瑞的格倫桑坦傑洛。
Glen Santangelo - Analyst
Glen Santangelo - Analyst
Eli, I hate to come back to the EBITDA guidance, but I did have a follow-up question.
Eli,我不想再回過頭來談論 EBITDA 指引,但我確實有一個後續問題。
When you look at 2024, it looks like your operating expenses increased 9%.
當你展望 2024 年時,你會發現你的營運費用增加了 9%。
And if I'm doing my math right, most of it looks like it was an increase in sales and marketing versus R&D and G&A.
如果我沒算錯的話,大部分成長看起來是銷售和行銷費用相對於研發和一般行政費用的成長。
And so I'm kind of curious, embedded within that '25 guidance, could you give us a sense for how much of an operating expense increase you're assuming this year versus last year?
因此,我有點好奇,在 25 年指引中,您能否告訴我們,您認為今年與去年相比,營運費用將增加多少?
And will it be more weighted towards sales and marketing or R&D.
它會更專注於銷售和行銷還是研發?
And then maybe as a part of that, could you talk about the impact that FX had in the top line and the operating profit guidance that you've given?
那麼也許作為其中的一部分,您能談談外匯對營業收入和您給出的營業利潤指引的影響嗎?
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Okay.
好的。
Thank you very much for the question.
非常感謝您的提問。
So first of all, in terms of the dynamics and OpEx, we are pretty much kind of aligned with our G&A, the movement on growing the sales and marketing, which is growing versus last year.
首先,就動態和營運支出而言,我們基本上與 G&A 保持一致,銷售和行銷的成長勢頭與去年相比有所增長。
But we need to understand that inside our R&D with what we call and what we actually introduce those financing programs that allowing us to finance the R&D.
但我們需要了解,在我們的研發內部,我們所謂的以及我們實際上引入的那些融資計劃使我們能夠為研發提供資金。
Those one actually supporting our olanzapine, our ICS/SABA and of course, the share cost that we have with Sanofi on the TL1A.
這些人實際上支持我們的奧氮平、ICS/SABA,當然還有我們與賽諾菲在 TL1A 上的分攤成本。
As we move forward, we are, as you know, about to in 2025 to submit olanzapine, which means that the cost on the Phase III is actually getting down, what we will see now more support on the rest of other programs.
隨著我們的不斷推進,正如你所知,我們即將在 2025 年提交奧氮平,這意味著第三階段的成本實際上正在下降,我們現在將看到對其他項目的更多支持。
So in some way, there is kind of a shift of those funding that happened in '24 to less funding that's happening in '25 on certain programs, which means that if we end up 5.9% on the R&D, we're growing above 6%.
因此,在某種程度上,某些項目在 2024 年投入的資金在 2025 年有所減少,這意味著,如果我們最終在研發上投入 5.9%,那麼我們的增長率將超過 6 .
So that's kind of the main change.
這就是主要的變化。
And our midpoint is taking above 28%.
我們的中點佔28%以上。
And on the OpEx and higher point is taking less than 28%.
而在 OpEx 上,較高點的佔比不到 28%。
As far as related to the FX look, last year, we saw kind of $190 million.
就外匯表現而言,去年我們看到了大約 1.9 億美元。
It's kind of 1.2%.
大概是 1.2%。
You will assume that that's more or less the range that we are considering in the spread in the current revenue trajectory guidance?
您是否認為這或多或少是我們在目前收入軌跡指導中考慮的範圍?
Operator
Operator
Chris Schott, JPMorgan.
摩根大通的克里斯·肖特 (Chris Schott)。
Chris Schott - Analyst
Chris Schott - Analyst
Just two questions for me.
我只有兩個問題。
Can you talk a little bit more about the fourth quarter US generic business?
您能否進一步談談第四季美國仿製藥業務的情況?
I know the first three quarters saw a very healthy growth.
我知道前三個季度的成長非常健康。
I think this quarter was a little bit less.
我認為本季的情況稍微少一些。
I'm just trying to understand, is that just timing or something we should be kind of watching there.
我只是想知道,這只是時間問題,還是我們應該觀察的某件事。
And my second question was coming back to the 2027, 30% operating margin target.
我的第二個問題是關於 2027 年 30% 的營業利益率目標。
Just tell me a little bit how much -- what type of gross margins should we be thinking about for Teva in that time frame?
請告訴我一下,在這段時間內我們應該考慮 Teva 的毛利率是多少?
I think we're always trying to kind of bridge with what seems like a pipeline that really deserves investment, launching a bunch of important products.
我認為,我們一直在嘗試建立一個真正值得投資的管道,推出一系列重要的產品。
It seems like gross margins is kind of one of the levers there.
看起來毛利率是其中的一個槓桿。
And I'm sorting it like how big of a step-up we should be anticipating versus the targets for this year.
我正在對它進行排序,看看相對於今年的目標,我們應該預期多大的成長。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Chris, thanks for the questions.
克里斯,謝謝你的提問。
So I'll take a bit with Eli on that.
因此我會和 Eli 討論一下這個問題。
So with regard to US generics, you're right.
因此,關於美國仿製藥,你是對的。
I think you said the fourth quarter you felt was a bit light, I think that was the question with US generics.
我想您說過您覺得第四季有點清淡,我認為這是美國仿製藥的問題。
I'd just like to remind you that Revlimid is allocated the majority of sales allocated in quarter two and quarter three.
我只是想提醒您,Revlimid 佔據了第二季和第三季的大部分銷售額。
And so that's where you see that sort of quarterly fluctuation in the US.
這就是你在美國看到的這種季度波動。
That said, I would like to point out that we did have a few good launches last year that helped minimize that, which I think is important.
儘管如此,我想指出的是,去年我們確實進行了一些良好的發布,有助於最大限度地減少這種情況,我認為這很重要。
So we had obviously Victoza, we had Opioid just to name a couple, which I think is sort of less than that.
所以我們顯然有 Victoza,我們有阿片類藥物,這只是其中的幾種,我認為它們的量比這要少一些。
But there is that seasonality, which you've always had in -- with regard to the Revlimid allocation, that's Q2 and Q3.
但就 Revlimid 的分配而言,存在季節性,即第二季和第三季。
And then on the gross margin, I'll sort of start it.
然後,關於毛利率,我會開始討論。
And I think your question was in two parts.
我認為您的問題分為兩部分。
I think it's what is the gross margin going to be when we think about '27?
我認為當我們考慮 27 時毛利率會是多少?
And Eli, you can take that, then I think there was a more sort of high-level question, which is how do you aspire to hit your OP and your gross margin and make sure you don't underinvest in the pipeline, which I think is also a very good question.
Eli,你可以接受這一點,那麼我認為還有一個更高層次的問題,那就是你如何實現你的營運利潤和毛利率,並確保你不會在通路上投資不足,我我覺得也是一個很好的問題。
So the way we think about it, it goes back to capital allocation, and a big part is making sure we do invest.
因此,我們的想法是,這又回到了資本配置,而很大一部分是確保我們確實進行投資。
And I think you've seen over the last two years, we've actually invested we've been all in, in our pipeline.
我想大家已經看到,在過去的兩年裡,我們實際上已經在我們的管道上進行了全力投資。
We've accelerated TL1A when we didn't have Sanofi.
當我們沒有賽諾菲時,我們加速了 TL1A 的發展。
We accelerated olanzapine, and we've accelerated ICS/SABA, we've moved some other products into the clinic.
我們加速了奧氮平,我們加速了 ICS/SABA,我們已將一些其他產品轉移到臨床上。
So I think we look after the pipeline really carefully, but we look after capital at the same time.
因此我認為我們非常小心地照顧管道,但同時也照顧資本。
So I think it's a balance that we always think carefully about.
所以我認為我們始終需要仔細考慮這個平衡問題。
And as we move forward, I think as the pipeline matures, we'll continue to show that due diligence.
隨著我們不斷前進,我認為隨著管道日趨成熟,我們將繼續表現出盡職盡責。
But what we need to keep doing and we believe we will be keep doing is driving the top line revenue, particularly from our inhibitive because that changes the gross margin, and it changes the profitability, which allows us to do that without really breaking investment sort of guidance.
但我們需要繼續做並且相信我們會繼續做的是推動營收,特別是從我們的抑制因素來看,因為這改變了毛利率,改變了盈利能力,這使我們能夠做到這一點而不會真正破壞投資方式的指導。
That's a balance we have to manage.
這是我們必須掌握的平衡。
But I like that challenge because it was all focused on driving long-term growth and long-term value creation because we have such an exciting pipeline.
但我喜歡這個挑戰,因為它完全專注於推動長期成長和長期價值創造,因為我們有如此令人興奮的管道。
But one we watch carefully.
但我們會密切關注。
But maybe over to you, Eli, specifically on the gross margin.
但也許Eli,具體關於毛利率的問題,請交給你了。
.
。
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Yeah.
是的。
Chris, thanks for the question.
克里斯,謝謝你的提問。
So look, we are we're looking on keep investing our OpEx over revenue, which the trend around 27% will move in the next, I would say, in '26, '27 on average because we have kind of, I would say, more acceleration on R&D this year.
所以,我們期待繼續將營運支出投資於收入,我認為在 26 年和 27 年,這一趨勢將平均達到 27% 左右,因為我們有點,我想說,今年研發力度進一步加大。
So this is why I mentioned that we end up -- we may end up with even 28% this year.
所以這就是我提到我們最終——今年我們甚至可能達到 28% 的原因。
But if we think about it on that trajectory on 27% OpEx and our view on 30% OP to give you kind of a range of 56% to 57%.
但是,如果我們考慮 27% 營運支出的軌跡以及 30% 營運支出的觀點,我們會得出 56% 到 57% 的範圍。
That said, that it will not -- most likely will be linear because it's really related to our mix on the innovative portfolio in terms of our able to grow that business.
也就是說,它不會——很可能是線性的,因為就我們發展業務的能力而言,它實際上與我們在創新產品組合上的組合有關。
And also related to what Richard mentioned in our acceleration programs that we're working on across our global operations.
這也與理查德提到的我們在全球營運中正在進行的加速計畫有關。
So you can say, in average, 70 basis points to 100 basis points increase year-over-year up to a range of 56 or 57 by end of '27.
因此,可以說,平均而言,年成長 70 到 100 個基點,到 27 年底將達到 56 或 57 個基點。
Hope that answers your questions, Chris.
希望這能回答你的問題,克里斯。
Thanks for your questions.
感謝您的提問。
Operator
Operator
At this time, we'll take no further questions.
目前,我們不再接受任何提問。
So I'll hand back to the speaker team for any further remarks.
因此,我將把發言權交還給演講團隊,以便他們可以發表進一步的評論。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Once again, I'd just like to thank everybody for dialing into the Teva call.
我再次感謝大家撥打 Teva 電話。
Thank you for your interest and your questions, and we look forward to giving you updates in a few months on the first quarter of 2025.
感謝您的關注和提問,我們期待在幾個月後為您提供 2025 年第一季的最新消息。
Have a good day.
祝你有美好的一天。
Operator
Operator
Thank you all for joining today's call.
感謝大家參加今天的電話會議。
You may now disconnect your lines.
現在您可以斷開線路了。