Alvotech SA (ALVO) 2025 Q2 法說會逐字稿

Welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for the first six months of 2025. A presentation accompanying today's earnings call was also published last night on our investor portal, investors.alvotech.com under News and Events. We will be referring to individual slides during the presentation today.

歡迎我們的聽眾。昨天晚上，公司發布了一份新聞稿，公佈了我們2025年上半年的財務表現。昨晚，我們的投資者入口網站 investors.alvotech.com 的「新聞與事件」欄位下也發布了今天的收益電話會議的簡報。在今天的簡報中我們將參考單獨的幻燈片。

Our press release, presentation, and statements that we make on the call today may include forward-looking statements. Please see our disclaimers on slide number 2 of the presentation. These statements do not ensure future performance and are subject to risks and uncertainties that are outlined in company filings with the Securities and Exchange Commission. Any risks and uncertainties could cause actual results to differ materially from forward-looking statements that are made. Presenting on today's call are Robert Wessman, Chairman and Chief Executive Officer of Alvotech; and Linda Jonsdottir, Chief Financial Officer. We also have with us on the call, Anil Okay, Chief Commercial Officer; and Joel Morales, outgoing CFO.

我們今天在電話會議上發布的新聞稿、簡報和聲明可能包含前瞻性陳述。請參閱簡報第 2 張投影片上的免責聲明。這些聲明並不保證未來的業績，並且受到公司向美國證券交易委員會提交的文件中概述的風險和不確定性的影響。任何風險和不確定性都可能導致實際結果與前瞻性陳述有重大差異。參加今天電話會議的有 Alvotech 董事長兼執行長 Robert Wessman 和財務長 Linda Jonsdottir。參加我們電話會議的還有商務長 Anil Okay 和即將離任的財務長 Joel Morales。

Robert will begin today's presentation with a summary of the first half of the year and quarter, including financial and business highlights. Linda will cover the financial performance in more detail. Following that, Robert has some closing statements, and then the team will be happy to take your questions.

羅伯特將在今天的演講中首先概述今年上半年和本季的情況，包括財務和業務亮點。Linda 將更詳細地介紹財務表現。接下來，羅伯特將發表一些結束語，然後團隊將很樂意回答您的問題。

And with that, I would like to turn the call over to Robert Wessman. Robert?

接下來，我想將電話轉給羅伯特‧韋斯曼 (Robert Wessman)。羅伯特？

Thank you, Benedikt, and thanks to everyone for joining us here today. I'm very pleased to have with me today our new CFO, Linda Jonsdottir, who joined our team in July. Linda has a background in finance and corporate leadership internationally, have worked across different industries as transportation, banking, food technology, and healthcare, both as a CFO and COO and Chairman. At the same time, I want to thank Joel Morales for his valuable part in Alvotech's journey as a CFO. We are very pleased here today to announce our operating results for the first half of the year and this quarter.

謝謝你，班尼迪克特，也謝謝今天與我們一起參加的各位。我很高興今天能邀請到我們的新任財務長琳達·喬斯多蒂爾 (Linda Jonsdottir)，她於 7 月加入我們的團隊。Linda 擁有國際金融和企業領導背景，曾在運輸、銀行、食品科技和醫療保健等不同行業擔任財務長、營運長和董事長。同時，我要感謝喬爾·莫拉萊斯 (Joel Morales) 作為財務長在 Alvotech 的發展歷程中發揮的寶貴作用。今天我們非常高興地在此宣布我們上半年和本季的經營業績。

These results confirms our continuing momentum as a leading global fully integrated biosimilar company. Alvotech's strong growth momentum in the first half of the year can be attributed to strong reorders, successful product launches, development progress, and improved efficiency in manufacturing. Among the highlights from this quarter, we saw good performance in major markets from our two marketed products. We signed significant partnership agreements for our early-stage pipeline. We increased our revenues in the first half of the year by 30% year-on-year. And we also delivered the fifth consecutive quarter of positive adjusted EBITDA.

這些結果證實了我們作為全球領先的全整合生物仿製藥公司的持續發展勢頭。Alvotech 上半年強勁的成長動能可歸因於強勁的重新訂單、成功的產品發布、開發進度以及製造效率的提高。本季的亮點之一是，我們看到我們銷售的兩款產品在主要市場表現良好。我們為早期研發管道簽署了重要的合作協議。我們上半年的營收年增了30%。我們也連續第五個季度實現了正向調整後 EBITDA。

The cash flow of the quarter from the operating activities reached $77 million, which is an improvement of USD161 million year-on-year. Product revenues in the first half of the year grew by over 200%, and product revenues in second quarter 2025 grew by 77% year-on-year. Product margins were 33%, driven by new product launches, growth in revenues from existing markets and increased product volumes. Linda will talk more about these financial results later in the call.

本季經營活動現金流達7,700萬美元，年增1.61億美元。上半年產品營收年增超過200%，2025年第二季產品營收年增77%。產品利潤率為 33%，這得益於新產品的推出、現有市場收入的成長以及產品數量的增加。Linda 稍後將在電話會議中詳細討論這些財務結果。

Let's now switch gears and discuss the performance of our marketed products. Starting with our biosimilar to Humira, which is marketed as SIMLANDI in America and some other parts of the world and as HUKYNDRA in Europe. In Europe, our partner continues to gain market share with HUKYNDRA, which has now entered its fourth year in the market in Europe. We are quite pleased with the solid performance of the biosimilars despite entering a fairly crowded market back in the year 2022.

現在讓我們換個話題，討論一下我們銷售的產品的性能。從我們的 Humira 生物相似藥開始，它在美國和世界其他一些地區以 SIMLANDI 的名稱銷售，在歐洲以 HUKYNDRA 的名稱銷售。在歐洲，我們的合作夥伴 HUKYNDRA 繼續贏得市場份額，目前 HUKYNDRA 已進入歐洲市場的第四年。儘管早在 2022 年就進入了相當擁擠的市場，但我們對生物相似藥的穩健表現感到非常滿意。

In the US, the Humira biosimilar market started opening up last year when our Humira biosimilar SIMLANDI was launched. As pharmacy benefit managers PBMs are starting to exclude the originator from formulary, we are now seeing an accelerated conversion to Humira biosimilars, which in July had reached over 40% share of the overall US Humira market as per our estimate. This is in line with our expectations that biosimilar conversion could reach 50% in the US Humira market by year-end. At the same time, I'm very pleased to say that Alvotech has the second largest market share as a biosimilar to Humira in the largest market in the world, the US market.

在美國，隨著我們的 Humira 生物相似藥 SIMLANDI 的推出，Humira 生物相似藥市場去年開始開放。隨著藥品福利管理機構 (PBM) 開始將原廠藥排除在處方集之外，我們現在看到向 Humira 生物相似藥的轉換正在加速，根據我們的估計，7 月份 Humira 生物仿製藥已佔據美國 Humira 整體市場的 40% 以上的份額。這符合我們的預期，今年年底，美國 Humira 市場的生物相似藥轉換率可能達到 50%。同時，我很高興地說，Alvotech 作為 Humira 的生物相似藥，在全球最大的市場——美國市場上擁有第二大市場份額。

We also continue launching this biosimilar in markets outside North America and Europe, and our partners now are selling a biosimilar to Humira in 33 markets globally. And we have gained marketing approvals in 67 markets total. And we are, therefore, continuing to roll out the product into new markets going forward. Our biosimilar to STELARA, AVT04 is marketed as SELARSDI in US and UZPRUVO in Europe.

我們也繼續在北美和歐洲以外的市場推出這種生物相似藥，我們的合作夥伴目前正在全球 33 個市場銷售 Humira 的生物相似藥。我們總共已在 67 個市場獲得行銷批准。因此，我們將繼續向新市場推出該產品。我們的 STELARA 生物相似藥 AVT04 在美國以 SELARSDI 的名稱銷售，在歐洲以 UZPRUVO 的名稱銷售。

We were the first entrant in Europe, Canada, and Japan last year with very strong results. We launched with Teva in the US market this February. UZPRUVO continues to outperform our expectations in Europe. Sales volumes are very strong, and we remain the biosimilar with the first or second largest market share in all the key markets in Europe.

去年，我們是歐洲、加拿大和日本的首批參賽者，並且取得了非常優異的成績。今年 2 月，我們與 Teva 合作進軍美國市場。UZPRUVO 在歐洲的表現持續超越我們的預期。銷售量非常強勁，我們仍然是歐洲所有主要市場中佔有第一或第二大市場份額的生物相似藥。

The uptake of STELARA biosimilar in US is progressing as we expected. Biosimilar share reached over 20% of overall STELARA market in US in July as per our estimate. With our product marketed under SELARSDI brand by Teva, we are on track with our internal forecast in terms of price and volume.

STELARA 生物相似藥在美國的推廣正在按照我們的預期進行。根據我們的估計，7 月生物相似藥在美國 STELARA 整體市場的份額已達到 20% 以上。我們的產品由 Teva 以 SELARSDI 品牌銷售，在價格和銷售方面，我們的內部預測與預期一致。

As mentioned on our last call, pricing in STELARA market is quite competitive with some of our competitors offering pricing that we believe are not sustainable in the long run. We are convinced that our strategy by focusing on product margin rather than volume and market share will prove more successful for all of our stakeholders in the long run. In the US, although we have not signed any private label, we have signed unbranded product deals with a few leading players through our commercial partner, Teva.

正如我們上次電話會議中提到的，STELARA 市場的定價相當有競爭力，我們的一些競爭對手提供的價格我們認為從長遠來看是不可持續的。我們堅信，從長遠來看，我們注重產品利潤而不是產量和市場份額的策略將為我們所有的利害關係人帶來更大的成功。在美國，雖然我們沒有簽署任何自有品牌，但我們已經透過商業合作夥伴 Teva 與一些領先的公司簽署了無品牌產品協議。

We have marketing application under review in major global markets for AVT03, our proposed biosimilar candidate to Prolia and XGEVA; AVT05, our proposed biosimilar to Simponi and Simponi Aria; and AVT05 proposed biosimilar to EYLEA. Finally, our marketing application for AVT23, our proposed biosimilar to Xolair, is currently under review in UK.

我們在全球主要市場對 AVT03 的上市申請進行審核，AVT03 是我們提出的 Prolia 和 XGEVA 的生物仿製藥候選藥物；AVT05 是我們提出的 Simponi 和 Simponi Aria 的生物仿製藥；AVT05 是我們提出的 EYLEA 的生物仿製藥。最後，我們提出的 Xolair 生物相似藥 AVT23 的營銷申請目前正在英國接受審查。

We also plan to file with EMA application for AVT23 in third quarter this year. We look forward to provide further information as we near the approval and launch stage for these products. As laid out at the beginning of this year, Alvotech has decided to ramp up its R&D effort significantly, expanding the industry most valuable R&D pipeline. In June, we completed our transaction of the R&D operation of Xbrane in Stockholm. And also, we bought the rights to a biosimilar candidate referencing Cimzia.

我們也計劃在今年第三季向 EMA 提交 AVT23 申請。隨著這些產品的審批和發布階段臨近，我們期待提供更多資訊。正如今年年初所製定的，Alvotech 已決定大幅加強研發力度，擴大業界最有價值的研發管道。6月份，我們完成了斯德哥爾摩Xbrane研發業務的交易。此外，我們也購買了 Cimzia 生物相似藥候選藥物的權利。

We continue to hire into our R&D team, both in Sweden and Iceland since then. The result of our enhanced R&D activity can also be seen in the recent partnership deals announced during the quarter. During the quarter, we expanded our partnership with Advanz Pharma, licensing European rights to four biosimilar candidates referencing ILARIS, KESIMPTA, Cimzia, and one undisclosed biologic. Advanz has shown great confidence in Alvotech by signing license deals for biosimilar referencing now more than 10 different biologics.

從那時起，我們繼續在瑞典和冰島招募研發團隊。我們加強研發活動的成果也可以在本季宣布的最新合作協議中看到。在本季度，我們擴大了與 Advanz Pharma 的合作夥伴關係，授權四種生物相似藥候選藥物在歐洲獲得權利，包括 ILARIS、KESIMPTA、Cimzia 和一種未公開的生物製劑。Advanz 透過簽署生物相似藥授權協議（目前涉及 10 多種不同的生物製劑）表現出對 Alvotech 的極大信心。

We also announced our second partnership deal with Dr. Reddy's, a collaboration to codevelop, manufacture, and commercialize a biosimilar candidate to KEYTRUDA. The collaboration will allow us to diversify and mitigate development risks and extend the global reach of biosimilars. Shortly after the end of second quarter, we completed our acquisition of Ivers-Lee in Switzerland. This acquisition gives us better control of the full value chain and increases our capabilities and flexibilities in assembly and packaging of our devices.

我們也宣布了與 Dr. Reddy's 達成的第二項合作協議，共同開發、生產和商業化 KEYTRUDA 的生物相似藥候選藥物。此次合作將使我們能夠分散和降低開發風險，並擴大生物相似藥的全球影響力。第二季結束後不久，我們完成了對瑞士 Ivers-Lee 的收購。此次收購使我們能夠更好地控制整個價值鏈，並提高我們在設備組裝和包裝方面的能力和靈活性。

Before I conclude, I would like to extend a special greeting to our many new Swedish investors as this is the first earnings call held after our official listing of Alvotech on Nasdaq Stockholm. After initial placement of about 7.9 million STRs on Stockholm market, float on the Stockholm Exchange has continued to increase. Shareholders are now able to trade Alvotech shares on three Nasdaq exchanges in Iceland, in US, and now in Sweden.

最後，我想向我們的眾多瑞典新投資者致以特別的問候，因為這是我們在納斯達克斯德哥爾摩正式上市 Alvotech 後舉行的第一次收益電話會議。在斯德哥爾摩市場首次發行約 790 萬份 STR 後，斯德哥爾摩交易所的流通量持續增加。股東現在可以在冰島、美國和瑞典的三家納斯達克交易所交易 Alvotech 股票。

The listing on the Nasdaq Stockholm further broadens our shareholder base and increases trading liquidity to the benefit of all investors interested in participating in Alvotech's exciting journey. In summary, we are very happy about the results of previous six months and our momentum going into the second half of the year.

在納斯達克斯德哥爾摩上市進一步擴大了我們的股東基礎，提高了交易流動性，使所有有興趣參與 Alvotech 激動人心的旅程的投資者受益。總而言之，我們對前六個月的表現以及下半年的發展勢頭感到非常滿意。

And with that, I would like to hand the call over to Linda. So Linda, over to you.

說完這些，我想把電話交給琳達。那麼琳達，交給你了。

Thank you, Robert. I'm very excited to join the fantastic team at Alvotech. And even though it has only been a few weeks, I can really feel the energy, the passion and drive of our people. And I'm happy to report that this is reflected in our numbers as well. So let's move to the key highlights for the financial results for Q2 and first half of the year.

謝謝你，羅伯特。我很高興加入 Alvotech 這個出色的團隊。儘管才過了幾個星期，我卻能真切感受到我們人民的活力、熱情和動力。我很高興地報告，這也反映在我們的數字上。那麼，讓我們來看看第二季和上半年財務表現的重點。

Overall, our performance in the first half of the year was strong, both in terms of revenue growth, margin expansion and continued cash flow robustness. Moving to slide 9 in the deck, highlighting our adjusted financial results, let me start with the revenues.

整體而言，我們上半年的業績表現強勁，無論是營收成長、利潤率擴大或現金流持續穩健。轉到投影片的第 9 張，重點介紹我們的調整後財務結果，讓我先從收入開始。

Revenues continue on a strong momentum, and we're up 30% at $306 million compared to $236 million in the first half of 2024. Our revenue growth year-on-year was mainly driven by strong product revenues coming in at $205 million in the first half of the year compared to $66 million in the same period last year.

營收持續保持強勁勢頭，與 2024 年上半年的 2.36 億美元相比，成長了 30%，達到 3.06 億美元。我們的營收年增主要得益於強勁的產品收入，今年上半年我們的產品收入達到 2.05 億美元，而去年同期為 6,600 萬美元。

The key driver for the increase year-on-year were increased sales of our biosimilar to Humira and continued success of our biosimilar to STELARA in Europe and its launch in the US in Q1 this year. Licensing revenues in first half were $101 million compared to very strong first half last year when licensing revenues were $170 million. This difference in licensing revenues was driven by the timing of development progress impacting R&D milestones.

同比成長的主要驅動力是我們的 Humira 生物相似藥銷量的成長以及我們的 STELARA 生物相似藥在歐洲的持續成功以及今年第一季在美國的上市。上半年的授權收入為 1.01 億美元，而去年上半年的授權收入非常強勁，為 1.7 億美元。許可收入的差異是由影響研發里程碑的開發進度時間所驅動的。

Revenue recognition of milestones can be lumpy. And during Q2 last year, we achieved a number of significant development milestones. We do expect a similar dynamic to occur this year towards the latter part of the year. Looking at Q2 specifically, we recognized total revenues of $173 million compared to $199 million in Q2 last year and $133 million in Q1 this year. The split between product revenues and licensing revenues in Q2 this year was $95 million and $78 million.

里程碑的收入確認可能會不均。去年第二季度，我們實現了許多重要的發展里程碑。我們確實預計今年下半年也會出現類似的動態。具體來看第二季度，我們實現的總營收為 1.73 億美元，而去年第二季為 1.99 億美元，今年第一季為 1.33 億美元。今年第二季產品收入和授權收入的分成分別為 9,500 萬美元和 7,800 萬美元。

After a very strong Q1, marked by the launch of our biosimilar to STELARA in the US, the second quarter benefited from increased demand for our biosimilar to Humira across key markets and our STELARA biosimilar in Europe. And to further illustrate the inherent lumpiness I referred to earlier in terms of quarterly phasing, we do expect product revenues as well as milestone revenues to soften in Q3, followed by a much stronger results in Q4.

繼第一季表現強勁（以在美國推出 STELARA 生物相似藥為標誌）之後，第二季度受益於主要市場對我們 Humira 生物相似藥以及歐洲對 STELARA 生物相似藥的需求增加。為了進一步說明我先前提到的季度分階段的內在不穩定性，我們確實預期產品收入和里程碑收入在第三季會減弱，而第四季的業績則會更加強勁。

Moving to operational performance and margins. In the first half of the year, the adjusted product margin was 33%, which is in line with our previously stated expectations of a mid-30% range for product margin in the period. Adjusted EBITDA in the first half was $54 million compared to $64 million during the same period in the prior year. And adjusted EBITDA in Q2 was $18 million versus $102 million during Q2 last year. This is a function of the lower contribution of licensing revenues as milestone revenues transferred directly to EBITDA.

轉向營運績效和利潤率。上半年，調整後的產品利潤率為33%，與我們先前預期的該期間產品利潤率30%左右的水平相符。上半年調整後 EBITDA 為 5,400 萬美元，而去年同期為 6,400 萬美元。第二季調整後的 EBITDA 為 1,800 萬美元，而去年第二季為 1.02 億美元。這是因為許可收入作為里程碑收入直接轉入 EBITDA，貢獻較低。

Turning to the next slide, you'll find a summary of our cash and liquidity. During the first half of 2025, we generated $77 million of positive cash flow from operations, which is a net improvement of $161 million compared to the same period last year. In Q2, specifically, we generated $59 million of positive cash flow from operations, which is a net improvement of $73 million year-on-year. In terms of operating cash flow, Q2 2025 is the strongest quarter in the history of Alvotech and demonstrates the strength of our core business operations, which is reflected in high product revenue collections during the period and is accomplished while we are still building inventory in preparation of new launches.

翻到下一張投影片，您會看到我們的現金和流動性摘要。2025 年上半年，我們產生了 7,700 萬美元的正經營現金流，與去年同期相比淨增加 1.61 億美元。具體來說，在第二季度，我們產生了 5,900 萬美元的正營運現金流，比去年同期淨增加 7,300 萬美元。就經營現金流而言，2025 年第二季度是 Alvotech 歷史上最強勁的一個季度，展現了我們核心業務運營的實力，這體現在該期間的高產品收入上，並且是在我們仍在為新產品的發布而建立庫存時實現的。

We've also taken a number of important steps in the first half of the year in terms of our capital structure. We closed the period ending June 30 with $1,139 million in debt and $151 million of cash on hand, which was positively impacted by operational performance and proceeds from our Swedish offering and private placement in June. As per the agreement reached with our lenders in late June and on the back of our improved financial performance over the past year, we were able to reduce the rate of interest on our existing senior secured term loan facility to SOFR plus 6% with a maturity date in 2029, which will reduce our cost of capital and lower Alvotech's interest payments in the first 12 months by an estimated $8.2 million.

今年上半年，我們在資本結構上也採取了許多重要措施。截至 6 月 30 日的財年末，我們的債務為 11.39 億美元，現金為 1.51 億美元，這得益於營運業績以及 6 月份瑞典發行和私募所得的正面影響。根據我們 6 月底與貸款方達成的協議，並基於我們過去一年財務業績的改善，我們得以將現有優先擔保定期貸款的利率降低至 SOFR 加 6%，到期日為 2029 年，這將降低我們的資本成本，並使 Alvotech 在前 12 個月的利息支付減少約 820 萬美元。

In Q2, we completed the acquisition of the R&D organization of Xbrane in Sweden and biosimilar candidate to Cimzia. The total purchase price was $28.9 million paid in cash by assumption of convertible debt and assumption of accounts payable. After the close of the quarter, we also announced the acquisition of Ivers-Lee in Switzerland. Both acquisitions are very important for our ongoing and future operations.

在第二季度，我們完成了瑞典Xbrane研發機構和Cimzia生物相似藥候選藥物的收購。總購買價格為 2,890 萬美元，以承擔可轉換債務和承擔應付帳款的方式以現金支付。本季結束後，我們也宣布收購瑞士的Ivers-Lee。這兩次收購對於我們現在和未來的營運都非常重要。

In the appendix to our presentation, you'll find a table with reconciliation of our reported to adjusted results. And finally, over the past few weeks, I have witnessed the strong team at Alvotech and their dedication to deliver with focus on operational excellence and financial performance. I'm excited to get to know the company better, both to identify and maximize the opportunities ahead and contributing to a sustainable long-term growth of the company for the benefit of all stakeholders.

在我們簡報的附錄中，您將找到一個表格，其中列出了我們報告的結果與調整後的結果。最後，在過去的幾周里，我見證了 Alvotech 強大的團隊及其對卓越營運和財務表現的專注奉獻精神。我很高興能夠更了解公司，以便發現並最大限度地利用未來的機遇，並為公司的長期永續成長做出貢獻，造福所有利害關係人。

And with that, I would like to hand the call over to Robert for some final remarks. Robert?

最後，我想將電話交給羅伯特，請他發表一些最後的評論。羅伯特？

Thanks, Linda. In closing, the second quarter was another strong quarter for Alvotech. We are expanding existing products into new markets and preparing for future launches. We will maintain focus on accelerating pipeline development going forward. At the same time, we are scaling manufacturing and increasing operational efficiencies.

謝謝，琳達。總而言之，第二季度對於 Alvotech 來說又是一個強勁的季度。我們正在將現有產品擴展到新市場並為未來的產品推出做準備。未來我們將繼續致力於加速管道建設。同時，我們正在擴大生產規模並提高營運效率。

Thank you, Robert and Linda. And let's now turn the call back over to the operator for Q&A.

謝謝你，羅伯特和琳達。現在讓我們將電話轉回給接線員進行問答。

(Operator Instructions) Christopher Uhde, SEB.

（操作員說明）Christopher Uhde，SEB。

So I guess a few. I'll take them one by one, if that's okay. Halfway through 2025, you're not changing guidance, but the Q2 was clearly at least a lot better than the Street predicted. So what can you tell us about your confidence in the top line guidance going forward? And then, I mean, you've previously indicated if memory serves that you have very high 6-month visibility. So is it fair to say we should not expect a guidance raise in Q3 then? That's my first question. Can you hear?

所以我猜有幾個。如果可以的話，我會一個一個地拿走它們。到 2025 年中期，你不會改變指導方針，但第二季度顯然至少比華爾街預測的要好得多。那麼，您能告訴我們您對未來營收指引的信心嗎？然後，我的意思是，如果您沒記錯的話，您之前已經表示過，您有非常高的 6 個月的可見性。那麼，是否可以公平地說，我們不應該期待第三季的指導價上調？這是我的第一個問題。你聽得見嗎？

Thanks for the question, and it's Linda here. I will at least -- I will touch on the guidance, perhaps just to start by summarizing a bit like Q2, I mean, we see a lot of strong momentum, both in the Q2 numbers and the first half and, of course, like underpinning the strong product revenue growth there, driving solid EBITDA results. We also see that like licensing revenues are impacted by timing of development milestones and cash flow from operation is strong. So I would say like a number of solid steps taken now in the first half. We have also said like in the past that revenue recognition is lumpy with respect to milestone revenues.

感謝您的提問，我是琳達。我至少會——我會談及指導，也許只是從總結第二季度的情況開始，我的意思是，我們看到了很多強勁的勢頭，無論是在第二季度的數據還是上半年，當然，就像支撐強勁的產品收入增長，推動穩健的 EBITDA 業績一樣。我們也發現，授權收入受到開發里程碑時間的影響，且營運現金流強勁。所以我想說，上半年我們已經採取了許多紮實的措施。我們也像過去一樣說過，里程碑收入的收入確認是不穩定的。

And there, if you like look into, for example, '24, we had a number of significant development milestones there. And we do expect similar dynamics now this year towards the latter part of the year. And that's why we also commented a bit on the quarterly phasing. We do expect product revenues as milestone revenues to be soft in Q3. So we are expecting Q4 to be much stronger. At the same time, like we are coming out with new launches, and we are building up inventories in connection to that. But otherwise, I mean, I only refer to our earlier guidance that we have stated before.

如果你喜歡研究的話，例如，‘24’，我們在那裡取得了許多重要的發展里程碑。我們確實預計今年下半年也會出現類似的動態。這就是我們對季度分階段做出一些評論的原因。我們確實預計，作為里程碑收入的產品收入在第三季將會疲軟。因此我們預計第四季度的表現會更加強勁。同時，我們正在推出新產品，並正在建立與此相關的庫存。但除此之外，我的意思是，我只參考我們之前聲明過的指示。

Okay. That's much appreciated. And then is there growth for SIMLANDI left from the Quallent channel in the US? Or should we view that particular channel as maxed out?

好的。非常感謝。那麼，SIMLANDI 在美國的 Quallent 管道中還有成長嗎？或者我們應該認為該特定頻道已經達到最大限度？

I can take this question, of course. So we do have still a valid contract with Quallent. However, our focus on all two in the US market is the value rather than the volume. So we do expect this business to be more challenging in the second half of the year. But we had a very good first half of the year volumes going to Quallent, and we do expect this business to continue.

我當然可以回答這個問題。所以我們與 Quallent 的合約仍然有效。然而，我們關注這兩家公司在美國市場的重點是價值，而不是數量。因此，我們確實預期這項業務在下半年將面臨更大的挑戰。但今年上半年我們向 Quallent 的銷售量非常好，我們確實希望這種業務能持續下去。

Okay. Then on, I guess, AVT03, 05 and 06, I guess most investors would see FDA inspections as the most likely reason for a delay to ultimate approval if one were to occur. Assuming you agree, should we expect any press releases once FDA has given feedback on the inspection outcomes?

好的。然後，我想，對於 AVT03、05 和 06，我想大多數投資者會認為 FDA 檢查是最終批准延遲的最可能原因（如果發生的話）。假設您同意，那麼 FDA 對檢查結果給出反饋後我們是否應該期待任何新聞稿？

Yes. I think, Robert here, thanks for the question. I mean, as a part of prior approval, if you will, we did have an inspection. And we believe that this is just as it as an ordinary course of business, if you will. And we, of course, are seeing we have had in the facility, both European health authorities, Japanese health authorities, FDA, and this is becoming just a part of our life.

是的。我想，我是羅伯特，謝謝你的提問。我的意思是，作為事先批准的一部分，如果你願意的話，我們確實進行了檢查。我們相信，這只是正常的業務流程，如果你願意的話。當然，我們看到，我們已經在該設施中設立了歐洲衛生當局、日本衛生當局和 FDA，這已經成為我們生活的一部分。

So we had already two FDA inspections last year. We, of course, sent out a press release on the first one when the facility got approved. The second one, late last year went very well. But I don't recall we did send out any press release around that. But of course, we will keep the market open and informed once we get approved on the approval on the products, if you will, going forward.

去年我們已經接受了兩次 FDA 檢查。當然，當該設施獲得批准時，我們首先發布了新聞稿。第二次是在去年年底，進展非常順利。但我不記得我們確實就此事發布過任何新聞稿。但當然，一旦我們的產品獲得批准，我們將保持市場開放和知情，如果你願意的話，繼續前進。

Ash Verma, UBS.

瑞銀的 Ash Verma。

Congrats to Linda, and Joel, you'll be missed. So maybe just -- I guess a couple of questions that I wanted to ask. Just on the guidance, I didn't see you guys like reiterating or kind of making any specific comment beyond what you're saying for 3Q. So where you are right now in terms of revenue in the first half? So $306 million, that is roughly at the 50% mark, the low end of the revenue that you had guided before, the $600 million to $700 million.

恭喜琳達和喬爾，我們會想念你們的。所以也許只是──我想我想問幾個問題。僅就指導而言，我沒有看到你們重申或發表任何超出第三季度所說的具體評論。那麼就上半年的收入而言，您目前處於什麼水準？所以 3.06 億美元大約是你之前預測的 6 億到 7 億美元收入的低端的 50% 左右。

So are we to assume that, that piece is intact? And then on EBITDA, $54 million adjusted EBITDA in first half versus your prior guidance was $200 million to $280 million. So where are we? Like that seems like roughly 20% -- 25%, I'm sorry, on the EBITDA in the first half. Are those like guidance ranges still intact? And I'm just trying to understand, is that something that you can expect despite the strong 4Q that you are indicating?

那我們可以假設那塊碎片是完整的嗎？然後就 EBITDA 而言，上半年調整後的 EBITDA 為 5,400 萬美元，而您先前的預期為 2 億至 2.8 億美元。那我們現在在哪裡？看起來這大約相當於上半年 EBITDA 的 20% 到 25%，抱歉。這些指導範圍是否仍然完好？我只是想了解一下，儘管您表示第四季度業績強勁，但這是否是您可以預料到的事情？

Yes, Robert here. I think the best answer is we are basically in line with what we expected, maybe slightly better first 6 months. And as Linda mentioned, there is some lumpiness in the quarters. So like last year, we will see the fourth quarter being by far the strongest quarter of the year. And for now, we have -- as mentioned already, we are not changing the guidance. So I would say, net-net, I mean, basically, what we are seeing in the first 6 months is in line with what we expected.

是的，我是羅伯特。我認為最好的答案是，我們基本上符合預期，前六個月可能略有改善。正如琳達所提到的，季度表現有些不平衡。因此，與去年一樣，我們將看到第四季成為今年迄今表現最強勁的季度。目前，正如我們已經提到的，我們不會改變指導方針。所以我想說，總體而言，我的意思是，基本上，我們在前 6 個月看到的情況與我們的預期一致。

Got it. Okay. And just maybe on -- I think some of the products that you mentioned, the dynamics. So for Humira, you're exiting 40% and expect that you can get to 50% by the end of the year in the US market share. Like if you can comment on like the market share dynamic that you expect to happen in the next year? And then just on STELARA, so where do you expect to get to the market share by the end of the year from the 20% that you have here?

知道了。好的。也許只是—我認為您提到的一些產品是動態的。因此，對於 Humira 而言，您目前已佔據 40% 的美國市場份額，並預計到今年年底可達到 50%。您能否評論一下您預計明年的市佔率動態？然後就 STELARA 而言，您預計到今年年底，您的市佔率將從目前的 20% 上升到多少？

Sure. Maybe let me take it, Ash. So a couple of answers to both products. First of all, let me start with AVT02 in Europe. So in Europe, we have successfully plugged in Biogaran as an additional partner in France.

當然。也許讓我來接受它，阿什。因此針對這兩種產品我給了幾個答案。首先，我先從歐洲的AVT02說起。因此，在歐洲，我們已成功將 Biogaran 納入法國的額外合作夥伴。

Remember, French market had only 15% biosimilar penetration. So we are now driving the biosimilar penetration in France, still a very sizable market for us to grow. So we have the best partner in France to drive that market together with STADA. So that's giving us additional volumes and better pricing. So in Europe, we continue to see a significant market share increase from last year to this year, 30% growth.

請記住，法國市場的生物相似藥滲透率僅為 15%。因此，我們現在正在推動生物相似藥在法國的滲透，這對我們而言仍然是一個非常有發展潛力的市場。因此，我們在法國擁有最好的合作夥伴，與 STADA 共同推動該市場。這給我們帶來了額外的銷售和更好的定價。因此在歐洲，我們看到市場份額從去年到今年持續顯著成長，成長了 30%。

So we are having a very steady growth and a very stable volume market share in Europe. And we expect to continue to grow in those markets, mostly driven by France, but also other markets are also contributing. So that's the European situation. If we go to US, as you have seen, we had multiple shipments to the US based on the purchase orders we had, both from Quallent and also from Teva.

因此，我們在歐洲擁有非常穩定的成長和非常穩定的市場份額。我們預計這些市場將繼續成長，主要由法國推動，但其他市場也將做出貢獻。這就是歐洲的情況。如果我們去美國，正如您所看到的，根據我們收到的採購訂單，我們有多批貨物運往美國，這些貨物既來自 Quallent，也來自 Teva。

And we continue to have a valid forecast from both companies for the second half of the year. And as their purchase orders come to us, we will continue to deliver. And what I can say in the US market, there are actually three companies who can really claim a certain position in the adalimumab market. These are, of course, us, Sandoz and Organon.

我們繼續從這兩家公司獲得今年下半年的有效預測。當他們的採購訂單到達我們手中時，我們將繼續交付。我可以說，在美國市場上，實際上有三家公司能夠在阿達木單抗市場上真正佔據一定的地位。當然，他們就是我們，Sandoz 和 Organon。

All other seven players are not having any meaningful share. So we are in a -- in our opinion, we are in a good position to drive this market further in the US. When it comes to AVT04, I think we have a very good position. And again, in both markets, let me start again with Europe, which was the earlier market that we launched. So we are still either one or number two in different markets in Europe.

其餘七名球員均未獲得任何有意義的份額。因此，我們認為，我們處於有利地位，可以進一步推動美國市場的發展。說到 AVT04，我認為我們處於非常有利的地位。再次，關於這兩個市場，讓我再次從歐洲開始，這是我們較早推出的市場。因此，我們在歐洲不同市場中仍然是第一或第二。

We continue to grow in a significant pace. So we are very happy with our performance in Europe for this product, and we continue to grow market share as we go through. In the US, also, we had a successful launch. And we also got already a couple of downstream accounts and independent accounts through Teva. So we are expecting our uptake in line with our assumptions in our 2025 guidance. So there is no surprise for us coming from the US market in AVT04 market.

我們繼續以顯著的速度成長。因此，我們對該產品在歐洲的表現非常滿意，我們的市場份額也在不斷增長。在美國，我們也成功推出了該產品。我們也透過 Teva 獲得了一些下游帳戶和獨立帳戶。因此，我們預計我們的吸收量將符合我們 2025 年指導中的假設。因此，對我們來說，來自美國市場的AVT04市場並不令人意外。

(Operator Instructions) Carl Byrnes, Northland Capital Markets.

（操作員指示）卡爾·伯恩斯 (Carl Byrnes)，北國資本市場 (Northland Capital Markets)。

Congratulations on the results. I'm wondering with respect to the BLAs in the US that you expect approval by year-end, do you have any concerns that any of them might slip into the first quarter of '26? Or you still remain highly confident that you will see all of those approved as well?

恭喜你取得這樣的成績。我想知道，對於您預計年底前批准的美國生物製品許可法案 (BLA)，您是否擔心其中任何一個法案可能會推遲到 2026 年第一季批准？或者您仍然非常有信心看到所有這些都會獲得批准？

Yes, Robert here. Thanks for the question. I mean we have set BsUFA dates, and we are targeting those dates. We have not given exact date. I think we gave months. So we believe that those are the dates we are still targeting. And typically, you are not seeing slippage on the BsUFA dates historically, I think.

是的，我是羅伯特。謝謝你的提問。我的意思是我們已經設定了 BsUFA 日期，我們正在瞄準這些日期。我們尚未給出確切日期。我想我們給了幾個月的時間。因此我們相信這些仍是我們的目標日期。而且我認為，通常情況下，從歷史上看，你不會看到 BsUFA 日期出現下滑。

Great. And then going back to -- sorry to beat the dead horse here with the guidance. If we look at product sales and we look at the midpoint, which is $375 million, you did $205 million already. So that implies $170 million for the second half of '25. Again, you mentioned the third quarter would be soft and then pick up in the fourth quarter.

偉大的。然後回到——很抱歉，在這裡重複指導。如果我們看一下產品銷售額，並且看一下中間點，即 3.75 億美元，那麼您的銷售額就已經是 2.05 億美元了。這意味著 2025 年下半年的收入為 1.7 億美元。再次，您提到第三季會比較疲軟，然後在第四季回升。

Does that $170 million gap still seem realistic? And then with respect to milestones, same thing, $275 million is basically the midpoint. You did a bit over $100 million, $101 million and change. So it leaves about $174 million. I would imagine most of that because of the timing of the BLAs is going to fall in the fourth quarter. Are those proper assumptions as well?

1.7 億美元的差距看起來還現實嗎？然後就里程碑而言，同樣的事情，2.75 億美元基本上是中點。你賺了 1 億多一點，1.01 億美元，還有一些零錢。所以還剩下大約1.74億美元。我認為，由於 BLA 的時間安排，大部分情況將在第四季度發生。這些也是正確的假設嗎？

Robert here again. I think overall, I mean, you are seeing a lot of the milestones coming throughout approvals and launches and also shipments coming out of approvals and launches. So I think -- and you had -- we had a similar situation, if you will, second quarter last year. So with our very high milestones, if you recall. So that's the basis for our forecast and the basis for why we believe that the fourth quarter will be, by far, the strongest one of this year.

羅伯特又來了。我認為總體而言，您會看到在批准和發布過程中以及批准和發布後的發貨過程中出現許多里程碑。所以我認為——如果你願意的話——我們在去年第二季也遇到類似的情況。如果你還記得的話，我們的里程碑非常高。這就是我們預測的基礎，也是我們認為第四季將是今年迄今最強勁的季度的基礎。

(Operator Instructions) Dear speakers, there are no further questions. I would now like to hand the conference over to Benedikt Stefansson for any closing remarks.

（操作員指示）尊敬的發言者，沒有其他問題了。現在，我想將會議交給 Benedikt Stefansson 做結束語。

Well, on behalf of the Alvotech team here in Iceland and all over the world, we want to thank you all for calling in, and please have a good day and evening wherever you are. Thanks, and goodbye.

好吧，我謹代表冰島和世界各地的 Alvotech 團隊，感謝大家的來電，無論您身在何處，祝您度過愉快的一天和夜晚。謝謝，再見。

This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.

今天的電話會議到此結束。感謝各位的參與。現在各位可以斷開連接了。祝你今天過得愉快。