Alvotech SA (ALVO) 2025 Q3 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Alvotech Q3 2025 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

您好，感謝您的耐心等待。歡迎參加 Alvotech 2025 年第三季財報電話會議。（操作人員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to your speaker today, Benedikt Stefansson, Vice President of Investor Relations and Global Communications. Please go ahead.

現在我謹將會議交給今天的演講嘉賓，投資者關係和全球傳播副總裁貝內特·斯特凡松。請繼續。

Thank you, and welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for the first nine months and third quarter of 2025. A presentation accompanying today's earnings call was also published under our investor portal, investors.alvotech.com, under News & Events.

謝謝大家，歡迎各位聽眾。昨晚，該公司發布新聞稿，公佈了 2025 年前九個月和第三季的財務業績。今天財報電話會議的簡報也發佈在我們的投資者入口網站 investors.alvotech.com 的「新聞與活動」專欄下。

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.

我們今天發布的新聞稿、簡報和電話會議上的聲明可能包含前瞻性聲明。請參閱簡報第 2 頁的免責聲明。這些聲明並不保證未來的業績，並且存在風險和不確定性，這些風險和不確定性已在公司向美國證券交易委員會提交的文件中列出。任何風險和不確定性都可能導致實際結果與所做的前瞻性陳述有重大差異。

Presenting on today's call are Robert Wessman, Chairman and Chief Executive Officer of Alvotech; Joseph McClellan, Chief Operating Officer; and Linda Jonsdottir, Chief Financial Officer. Also with us on the call is Balaji Prasad, Chief Strategy Officer. Robert will begin today's presentation with a discussion of the status of our pending biologics license application with the FDA and facility inspection and present some business highlights. Joseph will discuss the status of our development pipeline. Linda will conclude with a discussion of our financial statement and full-year guidance. Following the introductions, our team will be happy to take your questions.

出席今天電話會議的有：Alvotech 董事長兼執行長 Robert Wessman；營運長 Joseph McClellan；以及財務長 Linda Jonsdottir。與我們一起參加電話會議的還有首席策略長巴拉吉·普拉薩德。Robert 將在今天的演講中首先討論我們向 FDA 提交的生物製品許可證申請和設施檢查的最新情況，並介紹一些業務亮點。Joseph 將討論我們開發專案的進度。琳達將最後討論我們的財務報表和全年業績預期。介紹完畢後，我們的團隊將樂意回答您的問題。

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

接下來，我將把電話交給羅伯特‧韋斯曼。

Thank you, Benedikt, and thanks to everyone for joining us here today.

謝謝你，貝內特，也謝謝今天到場的各位。

Please turn to the slide number 4 in your deck. We are now approaching the end of very eventful year, marked by increased pipeline development, successful product approvals across multiple markets and growing licensing and products revenues. Alvotech has come a long way in its 12-year history. We have invested approximately $2 billion to build a global pure-play biosimilar company with integrated R&D and manufacturing under one roof. We commercialize globally through a network of nearly 20 partners, reaching over 90 countries worldwide.

請翻到投影片中的第4頁。我們現在即將結束這充滿變數的一年，這一年我們取得了顯著的成就，包括產品管線開發增加、產品在多個市場獲得成功批准以及許可和產品收入不斷增長。Alvotech 在其 12 年的發展歷程中取得了長足的進步。我們已投資約 20 億美元，打造一家集研發生產於一體的全球性純生物相似藥公司。我們透過近 20 個合作夥伴組成的網路在全球範圍內進行商業化，業務遍及全球 90 多個國家。

After launching our first biosimilar in 2022 and second biosimilar in 2024, we entered the US market last year. The 2024 global launches drove a 420% revenue growth in that year, and we are guiding approximately 20% growth for 2025. With exclusivity expiring on dozens of originator biologics each year and the regulators waiving costly efficacy trials, the biosimilar market is set for explosive growth. With resources and strong focus on developing and manufacturing biosimilars, Alvotech is well positioned to lead the charge.

在 2022 年推出首款生物相似藥，2024 年推出第二款生物相似藥之後，我們去年進入了美國市場。2024 年的全球發布推動了當年 420% 的營收成長，我們預計 2025 年將成長約 20%。由於每年有數十種原廠生物製劑的獨佔期到期，監管機構也免除了成本高昂的療效試驗，生物相似藥市場即將迎來爆發式增長。憑藉資源和對生物相似藥研發和生產的堅定承諾，Alvotech 已做好充分準備引領潮流。

In fact, we proactively responded to anticipated changes in regulatory guidelines by expanding our research and development initiatives approximately two years ago. More recently, we have further enhanced our R&D capabilities with the establishment of an operational base in Sweden. The result is already evident in our growing pipeline: 5 approved biosimilars, 12 other disclosed development programs, and already developed cell lines for additional 15 valuable targets, in total, targeting greater than $185 billion of originator markets.

事實上，大約兩年前，我們積極因應監管準則的預期變化，擴大了研發投入。最近，我們透過在瑞典建立營運基地，進一步增強了我們的研發能力。成果已在我們不斷增長的產品線中得到體現：5 個已批准的生物類似藥，12 個其他已公開的開發項目，以及針對另外 15 個有價值靶點的已開發細胞系，總計瞄準超過 1850 億美元的原研藥市場。

Now let me touch upon a few key points that I will discuss today and described on the following slide. This includes an update on the FDA process, our pipeline, a comment on the revised outlook for the year, and update on our marketed products.

現在讓我談談今天要討論的幾個關鍵點，這些內容將在下一張投影片中進行描述。其中包括 FDA 審批流程的最新進展、我們的研發管線、對年度展望修訂的評論以及我們已上市產品的最新進展。

So let's turn to the next slide. As announced last week, we received a complete response letter, or CRL, from the FDA for our BLA for the proposed biosimilar to Simponi. The sole reason noted in the CRL concerns unresolved issues identified by FDA during the inspection of our Reykjavik facility, which concluded in July of this year.

那我們來看下一張投影片。正如上周宣布的那樣，我們收到了 FDA 對我們提出的 Simponi 生物相似藥的 BLA 的完整回复函 (CRL)。CRL 中提到的唯一原因是 FDA 在今年 7 月結束對我們雷克雅未克工廠的檢查中發現的未解決問題。

Let me make it clear. This CRL did not change the status of Reykjavik manufacturing facility, which continues to be an FDA-approved site that produce and will continue to produce our current marketed products in US. Also, the site is approved to manufacture for global markets and continues to get approvals for our new product launches. The facilities referenced in our regulatory application, including our Reykjavik site, are of course regularly inspected by several global regulatory agencies as a routine part of the review process.

讓我把話說清楚。這份 CRL 並未改變雷克雅維克生產工廠的現狀，該工廠仍然是 FDA 批准的工廠，生產並將繼續生產我們目前在美國銷售的產品。此外，該工廠已獲準為全球市場生產產品，並且我們的新產品發布也持續獲得批准。我們監管申請中提到的設施，包括我們在雷克雅未克的工廠，當然會作為審查流程的例行部分，定期接受多個全球監管機構的檢查。

For example, both the European Medicines Agency and Japan's PMPA inspected our Reykjavik site earlier this year in support of our new product approvals in these markets that will occur in third and fourth quarter. Leveraging several successful inspection by many regulatory authorities, including recent inspection by FDA in the third quarter of 2024 which yielded only two minor Form 483 observations, we remain committed to continuous improvement of our manufacturing operations.

例如，今年早些時候，歐洲藥品管理局和日本藥品和醫療器材管理局 (PMPA) 都對我們在雷克雅未克的工廠進行了檢查，以支持我們在第三季和第四季在這些市場獲得新產品批准。憑藉多次成功的檢查，包括 2024 年第三季 FDA 的檢查（僅發現兩項輕微的 483 表格缺陷），我們將繼續致力於不斷改進我們的生產營運。

To support consistent and effective leadership at the site, we have expanded the responsibility of Joseph McClellan, current Chief Scientific Officer, by appointing him as Chief Operating Officer. In his role, Joseph will be responsible for technical operations as well as research and development, supply chain and project management. Before joining Alvotech in 2019, Joseph held positions of increased responsibility at Wyeth and Pfizer in the United States over a span of 17 years.

為了支持該站點的持續有效領導，我們擴大了現任首席科學官 Joseph McClellan 的職責範圍，任命他為首席營運長。Joseph 的職責包括技術營運、研發、供應鏈和專案管理。在 2019 年加入 Alvotech 之前，Joseph 曾在美國的 Wyeth 和 Pfizer 擔任多個職責不斷提升的職位，工作時間長達 17 年。

During his tenure at Alvotech, he has played a key role in advancing and strengthening our high-performing research and development organization and its pipeline. His commitment to uphold best-in-class quality standards and operational excellence will position Alvotech to address any concerns raised by FDA at our facility.

在 Alvotech 任職期間，他為推進和加強我們高效的研發組織及其產品線發揮了關鍵作用。他致力於維護一流的品質標準和卓越的營運水平，這將使 Alvotech 能夠解決 FDA 對我們工廠提出的任何問題。

Although we are disappointed by the approval delay resulting from the CRL, we remain committed to promptly resolve any outstanding matter relating to the facility. Once FDA provides clarity later this month on the specific issue identified during the inspection, we will address those in a timely manner. Once we respond to the CRL, we anticipate the approval of our BLA may be granted as early as the first half of 2026 in accordance with six months statutory review periods.

儘管我們對因 CRL 而導致的審批延遲感到失望，但我們仍致力於迅速解決與該設施有關的任何未決事項。一旦FDA在本月稍後就檢查中發現的具體問題作出明確說明，我們將及時處理這些問題。一旦我們對 CRL 作出回應，我們預計根據六個月的法定審查期，我們的 BLA 最早可能在 2026 年上半年獲得批准。

With this review timing, we still anticipate being one of the first, if not the only approved biosimilar to Simponi in US and other global markets. Of note, we have already received approval in Japan and UK. with the EMA approval expected shortly for our biosimilar to Simponi.

按照目前的審查時間，我們仍然預計，即使不是唯一獲批的，我們也會成為美國和其他全球市場上首批獲批的 Simponi 生物相似藥之一。值得注意的是，我們已經在日本和英國獲得了批准，預計不久後我們的 Simponi 生物相似藥也將獲得 EMA 的批准。

So please turn to the next slide addressing our revenue growth. Later in the call, Linda will discuss our third quarter financial results and full year guidance in detail. When we reported our full-year guidance in March, we signaled that the first half and second half of the year would be relatively balanced, while the fourth quarter would be the strongest of the year due to anticipated product approvals and launches which were occurring later in the year.

接下來請看下一張投影片，了解我們的收入成長情況。在稍後的電話會議中，琳達將詳細討論我們第三季的財務表現和全年業績預期。我們在 3 月發布全年業績預期時曾表示，上半年和下半年業績將相對平衡，而第四季度將是全年業績最強勁的季度，因為預計產品審批和上市將在今年晚些時候進行。

Following the receipt of CRL from FDA, we revised our outlook for full year to $570 million to $600 million top line revenues and adjusted EBITDA of $130 million to $150 million. We believe the costs incurred on temporary loss in product revenue a necessary investment in our future growth and will make the company stronger as we continue to expand our portfolio of products and launch into additional global markets.

在收到 FDA 的 CRL 後，我們將全年預期調整為營收 5.7 億美元至 6 億美元，調整後 EBITDA 1.3 億美元至 1.5 億美元。我們認為，因產品收入暫時損失而產生的成本是對我們未來發展的必要投資，隨著我們不斷擴大產品組合併進入更多全球市場，這將使公司更加強大。

As you can see on this slide, Alvotech's revenue growth has been extraordinary or 127% on average per year from 2021 to year-end 2024. With the latest guidance we have given, we are projecting a compounded average growth rate of 94% from 2021 until end of this year. As we are launching three more biosimilars this year, this contributes to both licensing and product revenues, and our strong pipeline and increased R&D will allow license revenues to continue to be a significant revenue contributor.

從這張投影片可以看出，Alvotech 的營收成長非常驚人，從 2021 年到 2024 年底，平均每年成長 127%。根據我們最新的預測，從 2021 年到今年年底，複合平均成長率預計為 94%。今年我們將推出三款新的生物相似藥，這將有助於增加授權收入和產品收入，而我們強大的產品線和不斷增長的研發投入將使授權收入繼續成為重要的收入來源。

We are very pleased to say that we are seeing very strong global interest in our enhanced product portfolio. We continue to sign numerous contracts with our partners globally, which will continue to deliver strong milestone revenues and secure strong market share globally going forward.

我們非常高興地看到，全球對我們升級後的產品組合表現出了非常濃厚的興趣。我們將繼續與全球合作夥伴簽署眾多合同，這將繼續帶來強勁的里程碑式收入，並在未來確保在全球範圍內獲得強大的市場份額。

So please turn to the next slide. Now I will turn to how the markets for the existing products have evolved. In the US, we continue to hold the second largest market share in the Humira biosimilar segment and our products remain the fastest-growing Humira biosimilar. The originator share is eroding and expected to fall below 50% of its original volume by year-end, with most volume continuing to shift to biosimilars and much smaller portion transitioning to novel therapies.

請翻到下一張投影片。現在我將談談現有產品的市場是如何演變的。在美國，我們繼續保持阿達木單抗生物相似藥市場份額第二的位置，而且我們的產品仍然是成長最快的阿達木單抗生物相似藥。原廠藥的市佔率正在萎縮，預計到年底將降至原先的 50% 以下，大部分市場份額將繼續轉向生物相似藥，而轉向創新療法的份額則要小得多。

In Europe, our partner, STADA, continues to grow volumes for Hukyndra. We have seen average quarter-on-quarter growth of 12% the last four quarters. Hukyndra now holds the top position in several of the 10 largest EU markets, including Austria and Sweden, and has reached 10% share in France, competing against 9 other biosimilars. In Canada, SIMLANDI, marketed with JAMP Pharma, remains the fastest-growing Humira biosimilar.

在歐洲，我們的合作夥伴 STADA 繼續擴大 Hukyndra 的銷售量。過去四個季度，我們實現了平均每季12%的成長。Hukyndra 目前在歐盟十大市場中的幾個市場佔據領先地位，包括奧地利和瑞典，並在法國達到了 10% 的市場份額，與另外 9 種生物類似藥競爭。在加拿大，與 JAMP Pharma 合作銷售的 SIMLANDI 仍然是成長最快的 Humira 生物相似藥。

With respect to our biosimilar to Stelara in US, our partner, Teva, continues to secure formulary coverage, and we are among the top 3 biosimilars on the market for this reference product. In Europe, we were first to launch Stelara biosimilar. And while the competition has increased, we are still holding a leading position in the European markets, where we have launched our product with about 10% share of the total Stelara market and 25% share of the biosimilar segment. We expect 50% of Stelara's European market to transition to biosimilars by year-end.

就我們在美國推出的 Stelara 生物相似藥而言，我們的合作夥伴 Teva 繼續確保獲得處方集覆蓋，並且我們是市場上針對該參考產品的前 3 名生物類似藥之一。在歐洲，我們率先推出了Stelara生物相似藥。儘管競爭加劇，但我們在歐洲市場仍然保持領先地位，我們的產品在歐洲市場上市時，佔據了 Stelara 市場約 10% 的份額，以及生物相似藥市場約 25% 的份額。我們預計到今年年底，Stelara 在歐洲市場的 50% 將過渡到生物相似藥。

With that, I will hand the call over to Joseph McClellan, who will discuss our portfolio, including the near-term launches. So over to you, Joseph.

接下來，我將把電話交給 Joseph McClellan，他將討論我們的產品組合，包括近期即將推出的產品。那麼，接下來就交給你了，約瑟夫。

Thank you, Robert. As described on the next slide, our products, AVT06, a biosimilar to Eylea; AVT05, a biosimilar to Simponi; and AVT03, a biosimilar to the dual products of Prolia and Xgeva, are scheduled for launch in Europe this quarter.

謝謝你，羅伯特。如上一張投影片所述，我們的產品 AVT06（Eylea 的生物相似藥）、AVT05（Simponi 的生物相似藥）和 AVT03（Prolia 和 Xgeva 的雙重產品生物相似藥）計劃於本季在歐洲上市。

AVT06 has received approval in Japan, the UK and the European Economic Area. Last week, the UK High Court rejected Regeneron's and Bayer's requests to stop Alvotech's manufacturing of its Eylea biosimilar in the UK. This ruling enables us to manufacture in anticipation of commercial launches after the Eylea supplementary protection certificates expire on November 23 of this year. We are prepared to launch AVT06 prefilled syringes and vials across Europe post expiry of exclusivity and look forward to entering the market with strong partners.

AVT06 已獲得日本、英國和歐洲經濟區的批准。上週，英國高等法院駁回了 Regeneron 和 Bayer 要求停止 Alvotech 在英國生產其 Eylea 生物相似藥的請求。這項裁決使我們能夠在 Eylea 補充保護證書於今年 11 月 23 日到期後，提前進行生產，為商業上市做好準備。我們已做好準備，在獨家經銷權到期後，在歐洲推出 AVT06 預灌封注射器和藥瓶，並期待與強大的合作夥伴一起進入市場。

AVT05 has already received approval in Japan and the UK and we are expecting a favorable decision from the European Commission for the EEA in the later part of November, following the EMA's CHMP recommendation early this summer. We intend to proceed with the launch properly after approval, anticipate being the sole biosimilar to Simponi available on the European market for several months. In Japan, we have secured the necessary rights and plan to initiate launch activities during the first half of 2026.

AVT05 已在日本和英國獲得批准，繼歐洲藥品管理局 (EMA) 於今年夏季早些時候向人用藥品委員會 (CHMP) 提出建議後，我們預計歐盟委員會將於 11 月下旬對歐洲經濟區 (EEA) 做出有利決定。我們計劃在獲得批准後順利推出該產品，預計在未來幾個月內，該產品將成為歐洲市場上唯一與 Simponi 類似的生物製劑。在日本，我們已經獲得了必要的權利，並計劃於 2026 年上半年啟動上市活動。

For AVT03, which has been approved in Japan, European Commission approval for the EEA is anticipated in the second half of November, following EMA's CHMP recommendation this summer. The intention is to ship launch supplies to our commercial partners in Europe during this quarter. It is expected that AVT03 will be among the first products available with established partners supporting its market introduction.

AVT03 已在日本獲得批准，繼歐洲藥品管理局 (EMA) 人用藥品委員會 (CHMP) 今年夏天提出建議後，預計歐盟委員會將於 11 月下半月批准其進入歐洲經濟區。本季我們將向歐洲的商業夥伴運送發射物資。預計 AVT03 將成為首批上市的產品之一，並有成熟的合作夥伴支持其市場推廣。

Turning to our development pipeline on the next slide. We are pleased to report ongoing growth and advancement across our programs. In collaboration with partners, Kashiv, and Advanz, we have submitted a biosimilar candidate to Xolair in the EEA and previously filed for approval in the UK, where the review process is ongoing.

下一頁將介紹我們的開發流程。我們很高興地報告，我們的各個專案都在持續發展和進步。我們與合作夥伴 Kashiv 和 Advanz 合作，已向歐洲經濟區的 Xolair 提交了生物相似藥候選產品，此前也已在英國提交了審批申請，目前審查過程仍在進行中。

The development of AVT29, a biosimilar candidate to high-dose Eylea; as well as AVT16/80, a biosimilar to Entyvio for both intravenous and subcutaneous administration, is proceeding towards regulatory submissions targeted for 2026. Progress continues on our candidate to Keytruda in partnership with Dr. Reddy's, including completion of manufacturing for clinical supplies. Additionally, we have initiated clinical manufacturing for our candidate to Cimzia with positive developments underway.

AVT29（一種高劑量 Eylea 的生物相似藥候選藥物）和 AVT16/80（一種用於靜脈注射和皮下注射的 Entyvio 生物類似藥）的開發工作正在推進，目標是在 2026 年提交監管申請。我們與瑞迪博士實驗室合作研發的 Keytruda 候選藥物取得了持續進展，包括完成了臨床供應的生產。此外，我們已啟動候選藥物 Cimzia 的臨床生產，目前進展順利。

Our investment in the early-stage pipeline remains strong. Today, we are announcing two new molecules, biosimilar candidates to Hemlibra and Imfinzi, which are currently in process development. Further, we have over 15 cell lines completed for future development within our expanding portfolio.

我們對早期研發管線的投資依然強勁。今天，我們宣布推出兩種新的分子，它們是 Hemlibra 和 Imfinzi 的生物類似藥候選藥物，目前正在進行製程開發。此外，我們已完成 15 多個細胞系的研發，以備未來在我們不斷擴大的產品組合中進行開發。

At this point, I invite Linda to deliver the financial overview.

此時，我請琳達作財務概覽。

Thank you, Joe, and good day to everyone who has joined us on the call today. Today, I will take you through the financials for Q3 and the first nine months of 2025. The earnings deck is more detailed than usual, and we hope you appreciate the additional insights into the quarterly results provided in the next few slides.

謝謝你，喬，也祝今天所有參加電話會議的朋友們今天愉快。今天，我將帶大家了解一下2025年第三季和前九個月的財務狀況。這份財報簡報比以往更加詳細，我們希望您能欣賞接下來幾張投影片中提供的更多關於季度業績的見解。

As Robert mentioned, Alvotech has delivered strong CAGR growth in the past four years since launching our first biosimilar, and there is continued momentum and demand appetite for our on-market products of biosimilars to Humira and Stelara.

正如羅伯特所提到的，自從我們推出第一款生物相似藥以來，Alvotech 在過去四年中實現了強勁的複合年增長率，並且我們已上市的 Humira 和 Stelara 生物類似藥產品也持續保持增長勢頭和市場需求。

Turning to the next slide, which highlights our Q3 financial performance. As we communicated, as part of our Q2 results, we were expecting Q3 to be a soft quarter followed by a strong Q4. This was primarily driven by lower product revenues and product margins, which were impacted by the timing of orders, portfolio mix, and temporary loss in product revenues related to facility improvements, as Robert noted earlier.

接下來請看下一張投影片，其中重點介紹了我們第三季的財務表現。正如我們在第二季業績報告中所傳達的那樣，我們預計第三季將是一個疲軟的季度，而第四季將表現強勁。這主要是由於產品收入和產品利潤率下降所致，而這又受到訂單時間、產品組合以及與設施改進相關的產品收入暫時損失的影響，正如羅伯特之前指出的那樣。

In Q3, licensing revenues were at the high level of $81 million, supporting a strong gross margin of 69%. We also finalized the integration of Ivers-Lee into our financials that were acquired in July. Ivers-Lee is a Swiss-based assembly and packaging service provider and will increase our capacity for finished product assembly and packaging.

第三季度，授權收入達到 8,100 萬美元的高位，毛利率高達 69%。我們也完成了將 Ivers-Lee 併入我們在 7 月收購的財務體系的工作。Ivers-Lee 是一家總部位於瑞士的組裝和包裝服務提供商，將提高我們成品組裝和包裝的能力。

Adjusted EBITDA was $14 million or 13% of revenues and was impacted during the quarter by costs associated with improvements in operations to support new launches. Operating cash flow is then a function of our revenue collections in the quarter, down from a very strong quarter in the second quarter of '25, and outflow driven by inventory build in support for upcoming launches.

經調整的 EBITDA 為 1,400 萬美元，佔營收的 13%，本季受到為支持新產品上市而進行的營運改善相關成本的影響。經營現金流取決於本季的收入，而 2025 年第二季的收入則非常強勁，同時，為支持即將推出的產品而增加的庫存也導致了現金流出。

And looking at the year to date on the next slide. Alvotech delivered total revenues of $420 million for the first nine months, which represents strong 24% growth year on year. This shows our strong commercial momentum following the launch of our biosimilar to Humira in the US and the early traction for our biosimilar to Stelara in both Europe and the US. Gross margin was at 59% and underscores the strength of our licensing model while product margin of 27% reflects quarter-three softness.

接下來請看下一張投影片，了解今年迄今的情況。Alvotech前九個月的總營收為4.2億美元，年增24%，表現強勁。這表明，繼我們在美國推出 Humira 生物相似藥之後，我們的商業勢頭強勁，而且我們在歐洲和美國推出的 Stelara 生物類似藥也取得了早期市場反響。毛利率為 59%，凸顯了我們授權模式的優勢，而產品毛利率為 27%，反映了第三季的疲軟態勢。

Adjusted EBITDA in the first nine months was $68 million or 16% margin. When compared to prior year, it is important to note that 2024 included very high licensing revenues tied to three biosimilar submissions and the US launch of our biosimilar to Humira, along with the launch of our biosimilar to Stelara in Europe. Cash balance at the end of September was $43 million and reflects outflows connected to inventory buildup ahead of product launches, CapEx investments, and M&A activity.

前九個月的調整後 EBITDA 為 6,800 萬美元，利潤率為 16%。與前一年相比，值得注意的是，2024 年的許可收入非常高，這主要得益於三個生物類似藥的申請以及我們在美國推出 Humira 生物類似藥，以及在歐洲推出 Stelara 生物類似藥。截至 9 月底，現金餘額為 4,300 萬美元，反映了與產品發布前的庫存累積、資本支出投資和併購活動相關的資金流出。

If we then double-click on the revenue and EBITDA trends on the next slide. Our revenue model as a B2B company naturally leads to quarterly fluctuations related to timing of orders from our partners. However, despite these fluctuations, we delivered strong double-digit growth in revenues both in the quarter and in the first nine months, up 11% and 24%, respectively, with a trailing 12-month run rate of $571 million in revenues.

然後，如果我們雙擊下一張投影片上的收入和 EBITDA 趨勢。作為一家 B2B 公司，我們的收入模式自然會導致與合作夥伴訂單時間相關的季度波動。然而，儘管存在這些波動，我們在本季度和前九個月的收入均實現了強勁的兩位數增長，分別增長了 11% 和 24%，過去 12 個月的收入運行率為 5.71 億美元。

Adjusted EBITDA margin for the first nine months 2025, however, was at 16% compared to 26% last year. This was driven by higher R&D investments to accelerate pipeline expansion as well as higher D&A costs to scale operations and infrastructure to be able to drive operational efficiency across the organization. Finally, I would like to highlight that we continue to diversify geographically with growing contributions from Europe as market share in Europe and other markets outside of the US continues to grow.

然而，2025 年前九個月的調整後 EBITDA 利潤率為 16%，而去年同期為 26%。這是由於研發投入增加，以加速產品線擴張，以及攤銷成本增加，以擴大營運和基礎設施規模，從而提高整個組織的營運效率。最後，我想強調的是，隨著我們在歐洲和其他美國以外市場的市場份額不斷增長，我們正持續實現地域多元化，來自歐洲的貢獻也不斷增加。

Moving to cash flow on the next slide. As I touched on earlier, cash flow in the quarter was a function of lower revenue collection due to timing and planned inventory buildup in support of upcoming launches. We also continued strategic investments in CapEx and intangibles to expand capacity to support new launches and our growth plans. New working capital option of $100 million will be used to capture swings in working capital. Cash is impacted by the costs associated with acquisition of Ivers-Lee and interest payments since from June '25, we are paying cash interest on our loans.

下一頁將介紹現金流。正如我之前提到的，本季的現金流是由於時間安排和為支持即將推出的產品而計劃的庫存累積導致收入減少所致。我們也持續對資本支出和無形資產進行策略性投資，以擴大產能，從而支持新產品的推出和我們的成長計畫。將啟用1億美元的新營運資金選項，以因應營運資金的波動。現金流量受到收購 Ivers-Lee 相關成本以及利息支付的影響，因為從 2025 年 6 月起，我們開始支付貸款的現金利息。

Next, I would like to quickly touch on the balance sheet on the next two slides. Our asset base remains strong, supported by recent bolt-on acquisitions and continued investment in R&D to drive future growth. Current assets are stable overall with expected shifts in inventory and trade receivables during the period.

接下來，我想在接下來的兩張投影片中快速介紹一下資產負債表。在近期收購和持續研發投入的支持下，我們的資產基礎依然強勁，這將推動未來的成長。總體而言，流動資產保持穩定，預計在此期間庫存和應收帳款將出現波動。

Looking into the equity and liability side, a couple of things to mention here. Our equity position strengthened by $236 million driven by profit for the period and the inflow of capital contributions from our most recent Swedish listing. Derivative financial liabilities decreased by $167 million, mainly due to fair value change on earn-out shares. And lastly, the overall contract liabilities decreased due to recognition of licensing revenues.

從權益和負債方面來看，有幾點需要說明。由於本期獲利以及我們最近在瑞典上市帶來的資本流入，我們的股權實力增強了 2.36 億美元。衍生性金融負債減少了 1.67 億美元，主因是獲利支付股份的公允價值變動。最後，由於確認了許可收入，整體合約負債減少了。

If we then turn to the next slide featuring our revised full-year outlook. On November 4, we revised our outlook following the CRL from the FDA. We updated our outlook for the full year to a range of $570 million to $600 million in revenues and adjusted EBITDA range of $130 million to $150 million. This revision reflects actions taken to respond to any issues identified by the FDA inspection, impacting production efficiency in 2025. Some of the licensing agreements for pipeline assets that were expected at the end of Q4 are now shifting to 2026.

接下來，我們來看下一張投影片，其中展示了我們修訂後的全年展望。11 月 4 日，在收到 FDA 的 CRL 後，我們修改了我們的展望。我們將全年預期營收範圍更新為 5.7 億美元至 6 億美元，調整後 EBITDA 範圍為 1.3 億美元至 1.5 億美元。本次修訂反映了為應對 FDA 檢查中發現的任何問題而採取的行動，這些問題可能會影響 2025 年的生產效率。一些原定於第四季末簽署的管道資產許可協議，現在推遲到了 2026 年。

Despite these short-term headwinds, we expect a strong finish to the year, especially with licensing revenues that translate directly to EBITDA. At the midpoint of the guidance, we are targeting to deliver 19% year-on-year revenue growth and 30% EBITDA growth. Fundamentals remain strong. We expect margin recovery and accelerated revenue contribution will follow new launches and continued geographical diversification.

儘管有這些短期不利因素，我們預計今年將取得強勁的收官業績，尤其是授權收入可以直接轉化為 EBITDA。根據業績指引的中點，我們的目標是實現19%的年營收成長和30%的EBITDA成長。基本面依然強勁。我們預計，隨著新產品的推出和地理範圍的不斷擴大，利潤率將有所回升，收入貢獻也將加速成長。

More importantly, we continue to see growth in markets outside the US which helps balance our revenue profile. Based on the committed orders we have for our new launches in markets outside the US, combined with the growth momentum we are seeing with our currently marketed products, we are well positioned to deliver top line and EBITDA growth in 2026. Management will provide new future guidance no later than with the Q4 '25 results.

更重要的是，我們在美國以外的市場持續成長，這有助於平衡我們的收入結構。根據我們在美國以外市場推出新產品的已承諾訂單，以及我們目前銷售產品的成長勢頭，我們有信心在 2026 年實現營收和 EBITDA 的成長。管理層最遲將於 2025 年第四季業績公佈時提供新的未來展望。

Our strategic focus for the next 18 months is on focused execution to unlock long-term growth, advancing the pipeline, realizing multiple global launches to deliver solid sales growth and diversification of revenues across geographies and products. At the same time, we will drive cost optimization and operational efficiencies to support margin expansion. Working capital management will also be our key focus to achieve positive free cash flow and support our growth trajectory.

未來 18 個月，我們的策略重點是集中精力執行，以釋放長期成長潛力，推進產品線，實現多項全球發布，從而帶來穩健的銷售成長，並實現跨地域和產品的收入多元化。同時，我們將推動成本優化和營運效率提升，以支持利潤率擴張。營運資金管理也將是我們實現正自由現金流和支持成長軌跡的關鍵。

This brings me to my final slide. I think it's always good to look a bit backwards and see where we're coming from, where we are today and where are we heading. Alvotech's journey from its 2013 foundation to today reflects the transformation into a leading biotech company with one of the industry's most valuable biosimilar pipelines.

這就引出了我的最後一張投影片。我認為回顧過去，看看我們從哪裡來，我們現在在哪裡，以及我們要去哪裡，總是很有益的。Alvotech 從 2013 年成立至今的發展歷程，體現了其轉型成為一家領先的生物技術公司，並擁有業界最有價值的生物相似藥研發管線之一。

From 2013 to 2023, the focus was on building a vertically integrated platform, investing in R&D and talent and establishing global partnerships to enable successful launches of Humira and Stelara biosimilars.

從 2013 年到 2023 年，重點是建立垂直整合平台，投資研發和人才，並建立全球合作夥伴關係，以實現 Humira 和 Stelara 生物相似藥的成功上市。

And 2024 to 2025 period marks a major inflection point, multiple global approvals, including those referencing Humira and Stelara in the US, accelerated pipeline development and fivefold revenue growth from '23 to '24. We achieved positive EBITDA in '24 and are targeting around 30% growth in 2025 on EBITDA level.

2024 年至 2025 年期間是一個重要的轉折點，包括在美國獲得 Humira 和 Stelara 在內的多項全球批准，加速了產品線開發，並且從 2023 年到 2024 年收入增長了五倍。我們在 2024 年實現了正 EBITDA，目標是到 2025 年 EBITDA 水準成長約 30%。

Looking ahead to 2026, our priorities are diversification and scale, advancing our pipeline, executing multiple global launches and critically adhering to regulatory standards and ensuring FDA compliance as a cornerstone of success. With a $20 billion addressable market for upcoming biosimilars, we are positioned to deliver sustainable growth and long-term shareholder value.

展望 2026 年，我們的優先事項是多元化和規模化，推進產品線，執行多項全球發布，並嚴格遵守監管標準，確保符合 FDA 標準，以此作為成功的基石。鑑於即將上市的生物相似藥市場規模達 200 億美元，我們有能力實現永續成長和長期股東價值。

I'll now turn the call back over to the operator for Q&A.

現在我將把電話轉回給接線生進行問答環節。

(Operator Instructions) Ash Verma, UBS.

（操作說明）Ash Verma，瑞銀集團。

So yes, I wanted to just get back to the focus on the CRL. So can you kind of explain this, what are the observations this time that are different from the last time? And I think you mentioned that you've effectively taken actions to resolve them. Just give us a status of where we are on that.

所以，是的，我只想回到CRL的討論上來。那麼，您能否解釋一下，這次的觀察結果與上次有哪些不同？我想你也提到過，你已經採取了有效的措施來解決這些問題。請告知我們目前的進展。

This is Joe McClellan, Chief Operating Officer for Alvotech. We have been in a situation where we have done a significant number of improvements since the inspection has concluded. The observations were not repeat observations. Let me say it clearly. There were no repeat observations in the deficiencies identified in the Form 483 from the FDA at the conclusion of the inspection.

這是Alvotech公司的營運長喬·麥克萊倫。自檢查結束以來，我們已經進行了大量改進。這些觀察結果並非重複觀察結果。讓我把話說清楚。檢查結束時，FDA 483 表格中指出的缺陷並沒有再次出現。

And so it's a number of things that we have to improve about the facility associated with some of our aspects associated with manufacturing, control of our facility, documentation, investigations. We have committed to the FDA to complete more than 180 different changes to address all of their observations plus more so that we will not be in the situation again. In doing this, we have now completed 93% of these commitments and we have communicated them to the FDA. We're in the process of completing additional actions that we will continue to keep the FDA updated on.

因此，我們需要在許多方面改進工廠，包括生產製造、工廠控制、文件記錄、調查等方面。我們已向 FDA 承諾完成 180 多項不同的改進措施，以解決他們提出的所有意見，並做出更多改進，以避免再次發生這種情況。到目前為止，我們已經完成了 93% 的承諾，並且已經將這些承諾告知了 FDA。我們正在完成其他一些工作，並將持續向FDA報告進度。

Got it. And just as a follow-up. So I know this Form 483, you have 10 observations. And even for Humira back a while ago, I think you ultimately climbed up to 18. Just taking a step back on the manufacturing facility, if this has been a little bit of a challenge, has that made you think about the strategic value of keeping the manufacturing in Iceland?

知道了。作為後續補充。我知道這張 483 表格，你有 10 個觀察值。即使是之前用 Humira 的時候，我覺得你最後也爬升到了 18。退一步來說，就製造工廠而言，如果這帶來了一些挑戰，這是否讓您思考將製造業務留在冰島的戰略價值？

I'm just trying to understand, is there something that is driven by less of an availability of pharma talent or anything of that regard, and whether if you would not have it at that location or at some other place, then it might ultimately solve the problem in the long run.

我只是想了解，是否存在由於醫藥人才短缺或其他類似原因造成的問題，以及如果將人才轉移到其他地方，從長遠來看，這是否最終可以解決問題。

Yes. Thank you for the question. Robert Wessman here, CEO. Overall, I mean, the concept and the vision and the strategy around the business is to keep everything in-house, both R&D and manufacturing. We think creating a platform like we have is extremely important.

是的。謝謝你的提問。我是執行長羅伯特·韋斯曼。總的來說，我的意思是，這家企業的理念、願景和策略是把所有環節都控制在公司內部，包括研發和生產。我們認為，創建像我們這樣的平台至關重要。

We can say that in US, we are around 18 months into being a commercial company, if you will. We have gone through three FDA inspections over the 18 months. And the first two, which was early '24, was only one 483. And then late last year, we had a general GMP inspection, which we only got two minor 483s.

可以說，在美國，我們作為一家商業公司已經運作了大約 18 個月。在過去的18個月裡，我們經歷了三次FDA檢查。而前兩次，也就是 24 年初，只有一台 483。然後，去年底，我們進行了一次全面的GMP檢查，結果只收到了兩份輕微的483表格。

So overall, I would say it was very disappointing to get this CRL and unexpected. But the company has continued to grow and strengthen further the quality systems, and we have full intention to absolutely stay and be best-in-class when it comes to GMP and quality. And I mean, that's reflected. We have gone through successfully five EMA inspections. We have gone through at least four inspections from different global health authorities and now two successful FDA inspections.

總的來說，收到這個 CRL 通知非常令人失望，而且出乎意料。但公司不斷發展壯大，進一步加強了品質體系，我們完全有決心在GMP和品質方面維持一流水準。我的意思是，這一點確實有所體現。我們已經順利通過了五次EMA檢查。我們至少接受過四次不同全球衛生機構的檢查，現在又成功通過了兩次美國食品藥物管理局（FDA）的檢查。

So as Joe explained in detail, we took this very seriously. And I think overall, we have done a substantial improvement. And Joseph himself has shown amazing success in R&D and brought all of our five currently approved or marketed products to a success and the 12 products which are in late stage in R&D. And he has extensive experience, as I mentioned in my part, from Pfizer. And he lives in Iceland.

正如喬詳細解釋的那樣，我們非常重視這件事。我認為總體而言，我們已經取得了實質的進步。約瑟夫本人在研發方面取得了驚人的成功，他使我們目前所有五款已獲批准或上市的產品以及 12 款處於研發後期階段的產品都取得了成功。正如我前面提到的，他在輝瑞公司擁有豐富的經驗。他住在冰島。

And that is a big factor, to have the core team living in Iceland to take charge. And I have great expectations with those changes that all future deficiencies hopefully will be behind us. But saying that, of course, we are in pharmaceuticals. We are seeing that companies, whether it is big pharma or biotech or biosimilars or small molecules, there are unfortunately FDA's 483s or even CRLs coming up on a very regular basis. So it's a kind of moving target and we will continue to move with it, if you will.

而讓核心團隊居住在冰島負責管理，這是一個重要因素。我對這些改變寄予厚望，希望未來所有不足之處都能迎刃而解。但話說回來，我們畢竟是身處製藥業。我們看到，無論是大型製藥公司、生技公司、生物類似藥公司或小分子藥物公司，都經常收到 FDA 的 483 表格甚至完全回覆函 (CRL)。所以這是一個不斷變化的目標，我們會繼續隨著它而改變。

Got it. Okay. I have just one more question. So I guess just for the three products that you've tried to pursue now with the FDA approval, you've gotten 2 CRLs. I mean, I'm trying to understand what type of impact does that create when you're having the conversations with your customers effectively.

知道了。好的。我還有一個問題。所以，我猜就目前你們嘗試推進的這三款獲得 FDA 批准的產品而言，你們已經收到了 2 份 CRL（完全回复函）。我的意思是，我想了解當你有效地與客戶對話時，會產生什麼樣的影響。

Is that something that you faced like when you were launching Humira, and now that you have seen this at the time of Stelara, then how do you think that might impact the conversation when you're trying to contract it out?

您在推出 Humira 時是否也遇到過這種情況？現在您在推出 Stelara 時也看到了這種情況，那麼您認為這會對您嘗試外包時的討論產生什麼影響？

Yes. I think it's a very appreciated question, if you will. I mean, we continue to see a very strong interest in our products. I mean, we definitely have the broadest portfolio of all biosimilar companies in the industry, and that is our strength. What is of interest, of course, leave aside 11, 12 successful inspection from EMA to US FDA to other health authorities in the world, our clients are doing also inspections or audits on ourselves.

是的。我認為這是一個非常值得探討的問題。我的意思是，我們持續看到市場對我們的產品表現出非常濃厚的興趣。我的意思是，我們絕對擁有業內所有生物相似藥公司中最廣泛的產品組合，這是我們的優勢。當然，除了成功通過 EMA、美國 FDA 以及世界其他衛生機構的 11、12 次檢查之外，值得關注的是，我們的客戶也在對我們進行檢查或審計。

So our customers are very much aware of the status of the facility. And overall, we have not seen any reduction of interest in our products. And we keep our key clients up to date, what we are doing to continue to evolve the quality system, if you will. And we highly appreciate that for all of our portfolio of products, there are usually more than one or more than two which are showing strong interest in those products at any given time.

因此，我們的客戶非常清楚該設施的狀況。整體而言，我們沒有看到消費者對我們產品的興趣下降。我們會及時向我們的主要客戶通報我們為不斷改進品質系統所做的工作。我們非常欣慰地看到，在我們所有的產品組合中，任何時候通常都有不只一位或兩位客戶對這些產品表現出濃厚的興趣。

Thibault Boutherin, Morgan Stanley.

Thibault Boutherin，摩根士丹利。

Just a couple of questions on the revenue impact of the CRL in Q4. Our understanding is that the lower revenue is related to fixing the manufacturing process, so basically revenue loss. Should we think about this as a phasing of shipment into next year after the issues are resolved? So is it just a sort of phasing? Or should we understand this as lost revenues?

關於 CRL 對第四季營收的影響，還有幾個問題。據我們了解，收入下降與改善生產流程有關，所以基本上就是收入損失。我們是否應該考慮在問題解決後，將出貨工作分階段延後到明年進行？所以這只是一種階段性變化嗎？或者我們應該將其理解為收入損失？

And does that mean that your commercial partner may face supply interruption impacting the revenues? So I'll start there, and I have another one after.

這是否意味著您的商業夥伴可能會面臨供應中斷，從而影響其收入？我就從這裡開始，之後我還有另一個。

Okay. It's Linda Jonsdottir here, CFO. If I understood your question correctly, it's about the change in guidance that we announced on November 4. I would say it's twofold. The revision is about like actions taken to respond to any issue. So that is slowing us down on the production side and impacting our revenues in 2025.

好的。我是財務長 Linda Jonsdottir。如果我理解正確的話，你的問題是關於我們在11月4日宣布的指導方針變更。我認為原因有兩方面。修訂內容類似於為應對任何問題而採取的行動。因此，這會減緩我們的生產速度，並影響我們 2025 年的收入。

But we are also seeing some of the licensing agreements for pipeline assets that were expected at the end of Q4 are now shifting to 2026. That's just like a timing impact but has sizable EBITDA impact in Q4 since it's like licensing revenues that flows directly into EBITDA.

但我們也看到，一些原定於第四季末簽署的管道資產許可協議，現在推遲到了 2026 年。這只是時間上的影響，但由於這相當於直接計入 EBITDA 的授權收入，因此對第四季度的 EBITDA 有相當大的影響。

However, like if I also comment a bit on 2026 and our comfort levels there, if I look into the committed orders we have for new launches in markets outside of US and in combination with growth momentum noted in currently marketed products, we are in a very good position to deliver top line and EBITDA growth in 2026.

但是，如果我再談談 2026 年以及我們屆時的信心，如果我看看我們在美國以外市場推出新產品的承諾訂單，再加上目前已上市產品的成長勢頭，我們完全有能力在 2026 年實現營收和 EBITDA 的成長。

And can you just confirm that you are confident on how long the operations are going to be impacted in terms of having visibility on how long it's going to take to fix it regardless of the answer you're expecting from the FDA? Or could this change depending on what you get from the FDA?

您能否確認一下，無論您預期FDA會給出什麼答复，您是否有把握預測出修復該問題需要多長時間，以及營運會受到多大影響？或者，這種情況可能會根據美國食品藥物管理局（FDA）的指示而改變？

No. Robert here again. I think we have a pretty clear visibility on that. And the drug product part of the facility is undergoing some minor adjustments as we speak. And we will then close the drug substance for a particular period in December for both general maintenance and adjustments.

不。我是羅伯特。我認為我們對此有相當清晰的認識。目前，該設施的藥品生產部分正在進行一些小的調整。然後，我們將於 12 月暫停該藥品的生產一段時間，以便進行一般維護和調整。

So I think as Linda said, we have most of the orders which are in the order book to be delivered end of this year produced. They still need to be -- some of them are sample to pack, but mostly they have been produced.

所以我覺得正如琳達所說，我們今年底前交付的訂單大部分都已經生產完了。它們還需要進行一些處理——其中一些是待包裝的樣品，但大部分已經生產出來了。

And we have a pretty good visibility how the year-end, we believe, and comfort level, how that will end. And as you can imagine, based on the guidance we gave and based on year-to-date EBITDA, it's fairly easy to see how strong the fourth quarter will be. And it's a good, as Linda said, good momentum with order book. So based on what we are seeing, we are fairly confident on growth, both top line and EBITDA for '26, no matter what.

我們對年底的情況有相當清晰的了解，我們相信，而且我們對最終結果也會感到滿意。正如你所想，根據我們給出的指引和年初至今的 EBITDA，很容易看出第四季度將會非常強勁。正如琳達所說，訂單量成長動能良好。因此，根據我們目前所看到的，無論如何，我們對 2026 年的營收和 EBITDA 的成長都相當有信心。

(Operator Instructions) Arvid Necander, DNB Carnegie.

（操作員說明）Arvid Necander，DNB 卡內基。

So going back briefly to the CRL and the slowdown in production you anticipated after it came. Could you be as concrete as possible? What amendments did you do to the ongoing production lines? And you touched on this a little bit, but is it fair to say that you're more or less back to operating at full capacity for the approved products?

所以，讓我們簡單回顧一下 CRL 以及它出現後您預期的生產放緩情況。您能盡可能具體一點嗎？你們對正在進行的生產線做了哪些改變？您剛才也稍微提到了這一點，但可以這樣說嗎？對於已核准的產品，你們的產能是否已經基本恢復到滿載運轉？

And secondly, on the R&D spend. At the beginning of the year, I think you were expecting R&D spend of roughly $160 million to $165 million for the full year. It seems to be trending higher than this. Do you anticipate a meaningful step down for Q4? I'll start there.

其次，關於研發支出。年初的時候，我想你們預計全年的研發支出大約在 1.6 億到 1.65 億美元之間。似乎還有上漲的趨勢。您預計第四季會大幅下滑嗎？我就從這裡開始。

One moment, please. Your conference will resume shortly.

請稍等片刻。會議即將繼續進行。

Okay. If I continue. So as I was saying, observations around putting in manufacturing controls, improving the way we do investigations, laboratory controls, documentation practices, those kinds of aspects. So we committed to doing over 180 different actions to the FDA, things such as ensuring that we have the microbial controls by putting measures in to prevent actions that could be considered.

好的。如果我繼續下去。正如我剛才所說，關於實施生產控制、改進調查方式、實驗室控制、文件規格等方面的觀察。因此，我們承諾向 FDA 採取 180 多項不同的行動，例如確保我們採取微生物控制措施，以防止可能採取的行動。

Because it's clear that the FDA made observations, for example, around our manufacturing controls that may lead to lack of sterility, but not that actually it was observed, right? So we did things to then strengthen that, putting practices in terms of how we do, say, for example, visual inspection, how we make sure that our air flow is correct to make sure that our procedures associated with changing and gowning are all improved, right?

因為很明顯，FDA 曾對我們的生產控制提出意見，這些意見可能導致無菌性不足，但並沒有實際觀察到這種情況，對嗎？因此，我們採取了一些措施來加強這方面，例如，在目視檢查方面，確保氣流正常，從而改進與更換和穿戴防護服相關的程序，對吧？

So we did all of those improvements over the last few months since July 4. Since then, we have begun manufacturing. The product that we are delivering in the fourth quarter is product that has been manufactured in both the third and the fourth quarter. So there are actions progressing. We are manufacturing.

所以，自7月4日以來的幾個月裡，我們完成了所有這些改進。從那時起，我們就開始生產製造。我們在第四季交付的產品，是第三季和第四季都生產的產品。所以，行動正在進行中。我們正在進行生產。

As Robert said, there's always going to be the need for minor actions for maintenance. Those things are taken into account, and we make sure that we improve those. But in general, we are manufacturing and delivering product that for this quarter that we have recently manufactured since the slowdown we referenced in the press release. Linda?

正如羅伯特所說，總是會有一些小的維護工作需要進行。這些因素我們都已考慮在內，我們將確保改進這些方面。但總的來說，我們正在生產和交付本季以來自我們在新聞稿中提到的經濟放緩以來最近生產的產品。琳達？

Yes. And to touch on your cost question, like on the R&D side, we had elevated levels on R&D both in Q2 and in Q3. That's also related to timing of clinical and manufacturing activities as well as launch preparation for our upcoming launches. In Q3, we also had impact in R&D related to the improvement Joe was covering. And we are expecting that also to touch our R&D numbers in Q4, but I can confirm that like we're still expecting lower R&D in Q4 than both in Q2 and Q3.

是的。至於你提到的成本問題，例如研發方面，我們在第二季和第三季的研發投入都比較高。這也與臨床和生產活動的進度安排以及我們即將推出的產品的上市準備工作有關。第三季度，我們在研發方面也取得了與喬所負責的改善相關的成果。我們預計這也會影響到我們第四季的研發支出，但我可以確認，我們預計第四季度的研發支出仍將低於第二季和第三季。

Thibault Boutherin, Morgan Stanley.

Thibault Boutherin，摩根士丹利。

Just a question on the impact of the change in regulation you mentioned with the lower requirement for Phase III trial. Can you talk a little bit about how that impacts your plan for your earlier stage biosimilars, in particular, thinking about Keytruda and Cimzia where the timelines could move based on your decision to run an efficacy study or not?

我有一個關於您提到的降低三期臨床試驗要求的法規變更的影響的問題。您能否談談這會對您早期生物相似藥的計劃產生怎樣的影響，特別是考慮到 Keytruda 和 Cimzia，它們的研發時間表可能會根據您是否決定進行療效研究而發生變化？

Yes. Robert Wessman here again. I will hand this over to Joseph, but I just want to underline. So we anticipated this change over two years ago. And based on that, we changed our approach to R&D, if you will.

是的。我是羅伯特·韋斯曼。我會把這個交給約瑟夫，但我只想強調一下。所以，我們早在兩年前就預料到了這種變化。基於此，我們改變了研發方法。

And as we have already stated on this call and the previous calls, we have all in all, between marketed products, approved products, late-stage development, early-stage development, over 30 products in the pipeline. So we think we have used the time very well and taking advantage of the changes which are coming now by kind of assuming and expecting this to come. So we are already bearing the fruits of that vision we had back in time.

正如我們在本次電話會議和先前的電話會議中已經提到的，我們總共有超過 30 種產品正在研發中，包括已上市產品、已獲批准產品、後期開發產品和早期開發產品。所以我們認為我們很好地利用了這段時間，並且透過預先設想和預期這些變化的到來，充分利用了即將到來的變化。所以，我們已經開始收穫當年那項遠見卓識的成果了。

But for the detailed answers maybe, Joe, if you take that.

但如果你想得到詳細的答案，喬，如果你接受這個建議的話。

Yes, absolutely. So this is Joseph. For sure, right, we are doubling down on our strategy. We have a proven development engine. We are leveraging that.

是的，絕對的。這就是約瑟。沒錯，我們正在加倍投入我們的策略。我們擁有成熟的開發引擎。我們正在利用這一點。

As Robert said, we forecasted and anticipated that the need to do patient efficacy studies was going to go away from a regulatory perspective. It has.

正如羅伯特所說，我們預測並預料到，從監管角度來看，進行患者療效研究的需求將會消失。確實如此。

And because we made the bets over two years ago, we are now in a good position to take advantage of that. And we are doing that for products as we're developing them, right? So you can imagine that, yes, Cimzia would be one of those as well.

因為我們兩年前就下了注，所以現在我們處於有利地位，可以利用這些賭注。我們在產品開發過程中也是這樣做的，對吧？所以你可以想像，是的，Cimzia 也是其中之一。

Thank you. There are no further questions at this time. I would like to hand back over to Benedikt Stefansson for closing remarks.

謝謝。目前沒有其他問題了。我謹將發言權交還給貝內特·斯特凡松，請他作總結發言。

Yes. Thank you. So on behalf of the Alvotech team, I would like to thank everyone who called in and listened to our call today. And we look forward to speaking with you again, and wish you a good rest of the day.

是的。謝謝。因此，我謹代表 Alvotech 團隊，感謝今天所有打電話進來收聽我們電話會議的朋友們。我們期待再次與您交談，並祝您今天餘下的時間過得愉快。

Thank you.

謝謝。

Thank you.

謝謝。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。