Alvotech SA (ALVO) 2024 Q3 法說會逐字稿

Good day. And thank you for standing by. Welcome to the Alvotech third quarter, 2024 earnings conference call. At this time. All participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session to ask a question during the session. You will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised to withdraw your question. Please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Benedikt Stefansson. Please go ahead.

再會。感謝您的支持。歡迎參加 Alvotech 2024 年第三季財報電話會議。此時。所有參與者都處於只聽模式。演講者演講結束後，將進行問答環節，在會議期間提出問題。您需要按電話上的星號 11。然後，您將聽到一條自動訊息，建議您舉手撤回問題。請再按星號 11。請注意，今天的會議正在錄製中。現在我想將會議交給今天的第一位發言人 Benedikt Stefansson。請繼續。

Thank you and good morning or afternoon to everyone joining us on this call today.

謝謝大家，今天參加我們電話會議的每個人都早安或下午好。

Yesterday evening, the company issued a press release that can be found on our website www.alvotech .com.

昨天晚上，該公司發布了一份新聞稿，您可以在我們的網站 www.alvotech.com 上找到該新聞稿。

The release reports, financial results for the first nine months of 2024 and provides a business update. Additionally, presentation slides that cover our call today have been posted on our investor website. You'll find all materials posted for the first nine months, 2024 earnest call under news and events in the events and presentations section on investors.alvotech.com, our presentation materials and some of our statements that we make today may include forward-looking statements.

新聞稿報告了 2024 年前 9 個月的財務表現並提供了業務更新。此外，涵蓋我們今天電話會議的簡報幻燈片已發佈在我們的投資者網站上。您可以在 Investors.alvotech.com 的活動和演示部分的新聞和活動下找到 2024 年前 9 個月的所有材料，我們的演示材料以及我們今天所做的一些聲明可能包含前瞻性內容聲明。

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.

這些聲明不能確保未來的業績，並受到公司向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。

These risks and uncertainties could cause actual results to differ materially from forward-looking statements that are made with me on today's call are Róbert Wessman, Chairman and Chief Executive Officer of Alvotech, Anil Okay, Chief Commercial Officer, Joel Morales, Chief Financial Officer, and Ming Li, Chief Strategy Officer.

這些風險和不確定性可能導致實際結果與 Alvotech 董事長兼執行長 Róbert Wessman、商務長 Anil Ok、財務長 Joel Morales 在今天的電話會議上做出的前瞻性聲明存在重大差異。 ，首席策略長。

With that, I would like to turn the call over to Róbert Wessman. Robert?

說到這裡，我想將電話轉給 Róbert Wessman。羅伯特？

Thank you, Benedikt and greetings to everyone joining us on the call today, we are very pleased with the result on the quarter on the first nine months of 2024 and the as well as the continued progress we are seeing in the business overall.

謝謝 Benedikt，並向今天加入我們電話會議的每個人致以問候，我們對 2024 年前 9 個月的季度業績以及我們在整體業務中看到的持續進展感到非常滿意。

Both are revenues for the first nine months of 2024 increased nearly nine times when we compared to the same period in 2023 revenues from the products for the first nine months rose to $128 million which was driven by an increase in product revenues in the third quarter as compared to the second quarter in 2024.

與 2023 年同期相比，2024 年前 9 個月的營收成長了近 9 倍，前 9 個月的產品營收成長至 1.28 億美元，這是由第三季產品營收成長推動的與2024 年第二季度相比。

As importantly, the company realized the material set of underlying product cross margins which more than doubled in the third quarter when compared to the second quarter. As we have discussed in the past, we expect a material increase in product gross margin in the second half of the year compared to the first half of the year. The drivers of improved margin are increased utilization of the manufacturing site and realization of the scale of activities for on market products and Ex US revenues for our biosimilars to stellar.

同樣重要的是，該公司意識到，與第二季相比，第三季的基礎產品交叉利潤率增加了一倍以上。正如我們過去所討論的，我們預計下半年產品毛利率將比上半年大幅成長。利潤率提高的驅動因素是生產基地利用率的提高、市場產品活動規模的實現以及我們的生物相似藥在美國以外的收入達到一流水平。

We do expect continued margin expansion due to better utilization and the shift in the product mix that will start to include Stelara biosimilar for us as well as expected contribution from new product such as AVT06 or proposed by similar to IIA AVT05. I buy a similar candidate to symphony and AVT03 or buy a similar candidate to Prolia and Xgeva milestone revenue here to date reach over $210 million while the majority of the revenue came in in the second quarter of this year. The third quarter saw expected revenues from existing partnerships and a few new partnership deals.

我們確實預計，由於利用率的提高和產品組合的轉變（將開始包括 Stelara 生物相似藥）以及 AVT06 等新產品或類似 IIA AVT05 提出的新產品的預期貢獻，我們預計利潤率將持續擴大。我購買了與 symphony 和 AVT03 類似的候選產品，或購買了與 Prolia 和 Xgeva 類似的候選產品。第三季的預期收入來自現有合作夥伴關係和一些新的合作夥伴交易。

We are thrilled with our ongoing progress and our path to become a leading global by a similar company.

我們對我們不斷取得的進步以及成為全球領先的類似公司的道路感到興奮。

While our historical results are indeed positive. I'm even more excited about the execution of our pipeline and strong business fundamentals we are focusing on today.

雖然我們的歷史成果確實是正面的。我對我們今天關注的管道的執行和強大的業務基礎感到更加興奮。

We believe these efforts are paving the way for sustained growth in the future. And with that, I would like to discuss some recent highlights in our business in September. The company concluded on inspection by the US FDA of our manufacturing site in Reykjavik, Iceland.

我們相信這些努力正在為未來的持續成長鋪平道路。在此，我想討論一下我們 9 月份業務的一些近期亮點。該公司結束了美國 FDA 對我們位於冰島雷克雅未克的生產基地的檢查。

This was an extensive general GEP inspection. This is taking place less than a year after the most recent inspection that paved the way for approvals from both the SI and C.

這是一次廣泛的 GEP 檢查。這是在最近一次檢查之後不到一年進行的，該檢查為 SI 和 C 的批准鋪平了道路。

It's common practice by FDA to inspect sites after making their initial commercial entrance into the US market.

FDA 的常見做法是在首次商業進入美國市場後進行檢查。

We of course welcome the opportunity to test the company and its system which have been heavily invested in over the past few years.

我們當然歡迎有機會測試該公司及其在過去幾年中投入巨資的系統。

We received two observations during this inspection and while we take all observation very seriously, we view the overall results as a validation of our past and ongoing efforts to continuously improve compliance of our manufacturing site. We do expect Intersys preapproval inspections for future filings and we also expect future FDA General GMP inspections to take place on a two-year cadence going forward.

我們在這次檢查期間收到了兩項觀察結果，雖然我們非常認真地對待所有觀察結果，但我們將整體結果視為對我們過去和持續努力不斷提高生產場所合規性的驗證。我們確實預計 Intersys 對未來的申請進行預先批准檢查，我們也預計未來 FDA 一般 GMP 檢查將以兩年的節奏進行。

I would like to thank the hard-working team of our tech for their commitment to quality and compliance and the excellent results achieved during this latest inspection of our facility.

我要感謝我們技術團隊的辛勤工作，感謝他們對品質和合規性的承諾，以及在對我們設施的最新檢查中取得的出色成果。

I would also like to extend our gratitude to the commercial partners who routinely inspect our manufacturing facility.

我也要向定期檢查我們生產設施的商業合作夥伴表示感謝。

This dynamic provides us with the new opportunities to enhance our quality systems and overall compliance and provides us comfort as we will continue to remain in good standing across the global markets.

這種動態為我們提供了增強品質系統和整體合規性的新機會，並讓我們感到安心，因為我們將繼續在全球市場上保持良好的信譽。

In addition to the recent inspection, we have continued to establish the base for future growth by advancing our pipeline and expanding our partnerships AVT16, our biosimilar candidate to TV is now in patient trials and we are the second company to reach the status in this growing market.

除了最近的檢查外，我們還透過推進我們的產品線和擴大我們的合作夥伴關係，繼續為未來的成長奠定基礎。家在這一不斷成長的領域達到這一地位的公司。

Furthermore, we have received email acceptance on our application for both AVT03 and AVT05, AVT03 is our proposed by a similar to both Prolia and Xgeva. And AVT05 is our by a similar candidate to symphony.

此外，我們也收到了 AVT03 和 AVT05 申請的電子郵件接受，AVT03 是我們由類似於 Prolia 和 Xgeva 提出的。AVT05 是我們與 symphony 類似的候選人。

Finally, in the US, we received approval for an additional FSTA of sell out by a similar to stellar.

最後，在美國，我們獲得了類似於恆星幣的額外 FSTA 出售的批准。

And more importantly, we will be launching in the US market in 2025 with all indications which was expected but also good to have completed. Now, overall, we are pleased with the continued execution by the company that we have seen in 2024.

更重要的是，我們將於 2025 年在美國市場推出，所有跡像都在預期之中，但也很好地完成了。現在，總體而言，我們對公司在 2024 年的持續執行感到滿意。

On the next slide, you can see the timelines of the events that demonstrate this execution and we have steadily been updating throughout the year.

在下一張投影片上，您可以看到展示這種執行力的事件的時間表，我們全年都在穩步更新。

As important as current financial results are it is equally important that we continue to execute on our business development progress and our research and development to secure that we have future opportunities.

與目前的財務表現一樣重要的是，我們繼續執行我們的業務發展進度和研發，以確保我們擁有未來的機會。

This allows the company to establish a steady cadence of revenue generating possibilities in the future to maintain growth.

這使得公司能夠在未來建立穩定的創收節奏，以保持成長。

Additionally, it is an important goal of the company to continue to diversify both products and markets as we strive to create a sustainable growth engine in the biosimilar space.

此外，公司的一個重要目標是繼續實現產品和市場多元化，我們努力在生物相似藥領域創造可持續的成長引擎。

With that, I would like to turn over the call to Anil Okay, our Chief Commercial Officer to give additional updates for the market on the pipeline over to you Anil.

說到這裡，我想將電話轉給我們的商務長阿尼爾·奧凱（Anil Ok），讓阿尼爾向您提供更多有關管道市場的最新資訊。

Thank you, Robert. I will start with a commercial update in the US. We continue to ramp up our supply to our US partners which include both private label as well as travel.

謝謝你，羅伯特。我將從美國的商業更新開始。我們持續增加對美國合作夥伴的供應，包括自有品牌和旅遊產品。

As we noted, we have approximately 1.3 million units in committed purchase orders for 2024 that we intend to supply this year.

正如我們所指出的，我們計劃在今年供應約 130 萬台 2024 年採購訂單。

Just over 40% of that has now been fulfilled through the third quarter.

其中 40% 以上現已在第三季完成。

So we do expect a meaningful step up in biosimilar Humira revenue for the US in the fourth quarter.

因此，我們確實預計第四季度美國生物相似藥 Humira 的營收將出現有意義的成長。

With the order cycle we have, we are also seeing first quarter shaping up nicely as well.

根據我們的訂單週期，我們也看到第一季的情況也不錯。

On the formulary side, we do expect expanded commercial coverage in the US and additional exclusionary actions by payers in the US market which we believe will contribute to a growth year for the product in 2025. Moving to biosim with Stelara, we recently announced that we have received approval on all indications for clarity, ensuring a full label launch in February of next year.

在處方方面，我們確實預計美國的商業覆蓋範圍將擴大，並且美國市場的付款人將採取更多排他性行動，我們相信這將有助於該產品在 2025 年實現增長。轉向與 Stelara 合作的 Biosim，我們最近宣布，為明確起見，我們已獲得所有適應症的批准，確保明年 2 月推出完整標籤。

We have submitted the necessary supplements to also gain interchangeability for the US market and the BAFA date for that is set for February 19th of next year.

我們已經提交了必要的補充資料，以獲得美國市場的可互換性，BAFA 日期定於明年 2 月 19 日。

If approved, we expect the approval to be provisional with final approval for interchangeability to happen in April as exclusivity for the first interchangeable product expires on the commercial front. We expect formulary coverage in 2025 and remain in conversations for potential private labeled businesses.

如果獲得批准，我們預計該批准將是臨時性的，最終批准的可互換性將於 4 月進行，因為第一個可互換產品的排他性在商業方面即將到期。我們預計 2025 年將涵蓋處方，並繼續與潛在的私人標籤企業進行對話。

We look forward to our year end call to provide further updates as well as an outlook for both opportunities in the media.

我們期待在年終電話會議上提供進一步的更新以及對媒體機會的展望。

Moving to the next slide, I would like to briefly discuss our commercialization efforts outside the US.

轉到下一張投影片，我想簡要討論我們在美國以外的商業化工作。

Two are very similar to Humira has now been launched in 26 markets globally including Canada and various European markets.

兩者非常相似，Humira 目前已在全球 26 個市場上市，包括加拿大和各個歐洲市場。

Although these launches occurred 4 to 5 years after loss of exclusivity, these initial launches were crucial for establishing our manufacturing systems and processes. Setting the stage for our global expansion.

儘管這些產品的發布是在失去排他性之後 4 到 5 年進行的，但這些最初的發布對於建立我們的製造系統和流程至關重要。為我們的全球擴張奠定基礎。

AVT04 are biosimilar to Stelara has now been introduced in 23 markets. Unlike AVT02, these were first in market launches, positioning us strongly for future growth.

AVT04 是 Stelara 的生物相似藥，現已在 23 個市場推出。與 AVT02 不同，這些產品首先在市場上推出，為我們未來的成長奠定了堅實的基礎。

The European Union remains a key focus for US and we are seeing strong demand for us. Provo, our Stelara biosimilar.

歐盟仍然是美國的重點關注點，我們看到對我們的強勁需求。Provo，我們的 Stelara 生物相似藥。

Our partner is a well established brand in the region and they are seeing success across both tender and retail channels. To put the opportunity in perspective. We anticipate that up to third of our product revenues will come from markets outside the US. In 2024 which highlights the diversification. We are seeing with our global strategy.

我們的合作夥伴是該地區的知名品牌，他們在招標和零售通路上都取得了成功。正確看待機會。我們預計我們多達三分之一的產品收入將來自美國以外的市場。2024年，多元化凸顯。我們正在透過我們的全球戰略看到這一點。

We expect this contribution to continue growing into 2025 driven by the maturation of existing launches and new launches from the three submissions we made this year.

我們預計，在現有產品的成熟以及我們今年提交的三份新產品的成熟推動下，這項貢獻將持續成長到 2025 年。

I would like to thank all of our partners across the globe for their strong efforts in driving biosim adoption which we collectively believe are important to enhancing the sustainability of health care systems around the world. Next, I would like to move to our near term pipeline which could yield launches as early as the end of 2025.

我要感謝我們在全球的所有合作夥伴為推動 Biosim 的採用所做的大力努力，我們共同認為這對於增強世界各地醫療保健系統的可持續性非常重要。接下來，我想談談我們的近期管道，最快可能在 2025 年底推出。

And we can start with a where we have announced recently that our application has been accepted for review in Europe.

我們可以從最近宣布我們的申請已在歐洲接受審查開始。

We will also announce filing acceptance in the US when that happens.

當這種情況發生時，我們也將宣佈在美國接受申請。

Please note that some announcements may not come until next year even if the filing and the Beva clock begins in 2024. As there is a lag between filing and acceptance with a laya. I would like to bring up a few relevant points. Firstly, we have developed both the prefilled syringe and the vile presentations for AVT06 are biosimilar to the original form of a lay based on our understanding of us requirements. We are one of four companies to develop the prefire as requisite studies would require patients rather than healthy volunteers because of the method of administration for this product, we have strong partnerships on this product across the globe and we expect to launch in Europe in 2025 as a day one launch.

請注意，即使備案和 Beva 時鐘從 2024 年開始，一些公告也可能要到明年才會發布。因為拉亞的提交和接受之間有一個滯後期。我想提出一些相關的觀點。首先，我們根據對我們需求的理解，開發了預充式註射器，並且 AVT06 的惡意演示與原始形式的生物類似。我們是開發預燃劑的四家公司之一，因為由於該產品的管理方法，必要的研究需要患者而不是健康志願者，我們在全球範圍內對該產品擁有強大的合作夥伴關係，我們預計將於2025 年在歐洲推出一天一發射。

And while the timing in the US is not 100% clear, the US market for a layer biosimilars is interesting as we know today, MGEN has defeated a preliminary injunction and has subsequently launched a version of an A layer biosimilar in the US. Others have either been permanently or preliminarily enjoined to enter the market based on existing formulation patents.

雖然美國的時機尚未 100% 明確，但正如我們今天所知，美國的 A 層生物相似藥市場很有趣，MGEN 已經擊敗了初步禁令，並隨後在美國推出了 A 層生物仿製藥的版本。其他產品則根據現有配方專利被永久或初步禁止進入市場。

While I won't get into details, we do have a different position against the patents versus the joint group.

雖然我不會透露細節，但我們對於專利與聯合小組確實有不同的立場。

And while I cannot commit to a date, we will certainly seek to launch as early as possible in the US market.

雖然我無法承諾具體日期，但我們肯定會尋求儘早在美國市場推出。

Also, as we have noted in the past, we are developing the high dose version of A which is a product that Regeneron is keen to switch patients to.

此外，正如我們過去所指出的，我們正在開發 A 的高劑量版本，這是 Regeneron 熱衷於讓患者改用的產品。

We have developed a formulation and are currently in the scale up phase.

我們已經開發出一種配方，目前正處於放大階段。

Additionally, we are working through the regulatory process and are seeking the most expedited path to market in all applicable markets. Again, there is additional IP on the formulation and we have developed our product. With that in mind, we look forward to providing updates for biosimilar candidates to high and love those as the development programs progress moving on to the next two products in our near term pipeline. I can provide brief updates on our candidates to buy a similar Simponi and Simponi Aria as well as Prolia and Xgeva in symphony. We just announced that our marketing application has been accepted for review by email and we also expect submissions to occur in the US still within this year.

此外，我們正在完成監管流程，並尋求在所有適用市場中最快捷的上市途徑。同樣，配方上有額外的智慧財產權，我們已經開發了我們的產品。考慮到這一點，隨著開發計劃的進展轉向我們近期管道中的下兩個產品，我們期待為生物仿製藥候選者提供高水平和喜愛的更新。我可以提供有關購買類似 Simponi 和 Simponi Aria 以及 Prolia 和 Xgeva in symphony 的候選人的簡短更新資訊。我們剛剛宣布，我們的行銷申請已透過電子郵件接受審核，我們也預計今年內仍將在美國提交申請。

In Europe, we are the first and currently only submission for a biosimilar to Simponi and we expect the same in the US and potentially other markets were refiled.

在歐洲，我們是第一個也是目前唯一提交 Simponi 生物相似藥的公司，我們預計美國和其他潛在市場也會重新提交相同的申請。

We view AVT05 as the potential end of 2025 launch opportunity and are excited at the potential to launch the product in what will clearly be a limited competition market in terms of other biosimilar players.

我們認為 AVT05 是 2025 年底潛在的上市機會，並且對於在其他生物相似藥廠商的競爭明顯有限的市場中推出該產品的潛力感到興奮。

As a reminder, only one other company has completed a clinical trial utilizing it proposed by a similar to symphony.

提醒一下，只有另一家公司完成了利用類似 symphony 的建議的臨床試驗。

Further in the US, the product is substantially split between two forms. The branded product is offered as an auto injector at Simponi and the vial for infusion as Simponi Aria

此外，在美國，該產品基本上分為兩種形式。該品牌產品在 Simponi 中作為自動注射器提供，而輸液瓶則作為 Simponi Aria 提供

We will be submitting our proposed biosimilar in separate filings this year.

今年我們將在單獨的文件中提交我們提議的生物相似藥。

Moving on to our very similar candidate to Prolia and Xgeva we have also recently announced marketing application acceptance by email and expect to file the product prior to your end in the US.

轉向與 Prolia 和 Xgeva 非常相似的候選產品，我們最近也透過電子郵件宣布接受行銷申請，並希望在您到達美國之前提交該產品。

The product is both a pharmacy and a medical benefit product in the US. And we have executed major contracts this year to ensure we have excellent commercial backing in both the US and in Europe together with our commercial partners. We look forward to a number of exciting launches in 2025 and 2026 from our near term pipeline.

該產品在美國既是藥品又是醫療福利產品。今年我們簽署了重大合同，以確保我們與商業合作夥伴一起在美國和歐洲擁有出色的商業支援。我們期待在 2025 年和 2026 年推出一系列令人興奮的近期產品。

Moving to the next slide, I will close my portion of our prepared remarks with a snapshot of our overall portfolio.

轉到下一張投影片，我將以我們整體作品集的快照來結束我們準備好的發言部分。

As we have said in the past, we believe in a broad portfolio approach which can concurrently increase the future opportunities while enhancing opportunities for existing on market products.

正如我們過去所說，我們相信廣泛的投資組合方法可以同時增加未來的機會，同時增加現有市場產品的機會。

And while our committed portfolio remains outlined on this list, we maintain an active cell line development group that is dedicated to our R&D platform. To put that into perspective. We have developed 15 additional cell lines outside of this list and are constantly working on a broad base of opportunities which provides us flexibility in our development as we choose to move programs forward, we are very proud of the achievements of our development team and our pipeline is one of the largest and most expensive in the industry.

雖然我們承諾的產品組合仍然列在這個清單中，但我們仍然擁有一個活躍的細胞系開發小組，專門致力於我們的研發平台。正確看待這一點。我們在此列表之外開發了15 個額外的細胞系，並不斷致力於廣泛的機會基礎，這為我們選擇推進項目提供了開發靈活性，我們對我們的開發團隊和管道所取得的成就感到非常自豪是業內最大且最昂貴的之一。

This underscores our long term commitment to biosim.

這強調了我們對 Biosim 的長期承諾。

I would like to now turn the call over to Joel Morales, Our Chief Financial Officer. Thank you.

我現在想將電話轉給我們的財務長喬爾·莫拉萊斯 (Joel Morales)。謝謝。

Thank you, Anil. I'll now provide financial highlights for the period ending September 30, 2024, with respect to our operating performance overall. During the third quarter, we continued to build upon the positive momentum we established during Q2 product revenues are growing as our partners launch our products into us and rest of world markets.

謝謝你，阿尼爾。我現在將提供截至 2024 年 9 月 30 日的財務摘要，涉及我們的整體營運表現。在第三季度，隨著我們的合作夥伴向我們和世界其他市場推出我們的產品，我們繼續在第二季度建立的積極勢頭的基礎上繼續發展，產品收入不斷增長。

The company has delivered our second consecutive positive operating profit and adjusted EBITDA quarter and we continue to be focused on operational execution to maximize the potential of our launches. As we conclude the final quarter of the year, total revenues for the nine months ended were 339 million versus 38 million during the same period in the prior year, representing an almost nine times increase, product revenues were 128 million. An increase of 98 million or 330% versus the prior year.

該公司已連續第二個季度實現正營業利潤和調整後的 EBITDA，我們將繼續專注於營運執行，以最大限度地發揮我們產品的潛力。當我們結束今年最後一個季度時，截至九個月的總收入為 3.39 億美元，而去年同期為 3,800 萬美元，幾乎增長了九倍，產品收入為 1.28 億美元。比前一年增加 9,800 萬，即 330%。

And milestone revenues were 211 million versus 8 million for the same period. In 23 this top line performance was driven by another consecutive quarter of increasing product revenues and continued milestone revenue recognition where total revenues for the third quarter were 103 million versus 18 million in the prior year.

里程碑收入為 2.11 億美元，而同期為 800 萬美元。23 年，這項營收表現是由產品收入又連續一個季度增長以及持續的里程碑式收入確認推動的，第三季度的總收入為 1.03 億美元，而上一年為 1800 萬美元。

Product revenues in the third quarter were 62 million. The highest recorded quarter by Altek, an increase of 16% from Q2.

第三季產品收入為6200萬美元。Altek 創歷史最高季度業績，較第二季成長 16%。

This quarter over quarter increase is driven by higher shipments of ACT02 for the US market as we continue to ship product in line with the orders we've received and we expect these shipments to continue stepping up into the fourth quarter.

本季環比成長是由美國市場 ACT02 出貨量增加所推動的，因為我們繼續按照收到的訂單出貨，並且我們預計這些出貨量將繼續增加到第四季度。

Additionally, in Q3, we also continue to expand upon our launches of four are biosimilar to Stelara to ex US markets as our commercial partner expands their presence into European markets and we also continue to supply into the Japanese market product margin. In Q3 specifically reached 37% compared to 17% in Q2 driven by a combination of increased shipments of AVT02 into the US and new product launches of AVT04 into Europe all while we continue to scale our operations during Q3, we also recognized 41 million in milestones driven by submissions of our AVT06 and AVT03 programs for marketing approval in Europe and the launch of AVT04 into European markets.

此外，在第三季度，隨著我們的商業合作夥伴將業務擴展到歐洲市場，我們也繼續向美國以外市場推出四種 Stelara 生物相似藥，我們也繼續向日本市場供應產品利潤。在美國AVT02 出貨量增加以及歐洲AVT04 新產品推出的共同推動下，第三季度達到了37%，而第二季度為17%，同時我們在第三季度繼續擴大業務規模，我們還實現了4100萬的里程碑推動我們提交 AVT06 和 AVT03 計劃以獲得歐洲行銷批准以及將 AVT04 推向歐洲市場。

Additionally, new licensing deals for our available programs were secured driving further revenue recognition.

此外，我們的可用程序的新許可協議也得到了進一步推動收入確認。

We continue to make significant advancements in our pipeline and where possible pursue opportunities to accelerate the progress of our development programs.

我們繼續在我們的管道中取得重大進展，並在可能的情況下尋求機會來加速我們的開發計劃的進展。

The signing of new licensing agreements and accelerated development progress can lead to higher than anticipated milestone revenues.

新授權協議的簽署和加速的開發進度可能會帶來高於預期的里程碑收入。

Reported operating profit was 56 million for the first nine months compared to negative 278 million for the same period. In 2023 the increase of 344 million was primarily attributable to our top line growth coupled with relatively flat cost of product revenues due to increasing manufacturing production, reduced production related charges and lower costs associated with FDA inspection readiness.

前 9 個月報告的營業利潤為 5,600 萬美元，而同期為負 2.78 億美元。2023 年，成長 3.44 億美元主要歸因於我們的營收成長，以及由於製造產量增加、生產相關費用減少以及與 FDA 檢查準備相關的成本降低而導致產品收入成本相對平穩。

Additionally, operating expenses decreased versus prior year, primarily due to lower R&D driven by a one time charge of 18.5 million associated with the termination of a co development agreement, lower overall R&D expenses and lower G&A driven by continuing efforts of the company to optimize our operations as we drive scale for the first nine months of 2024 we reported adjusted EBITDA of 87 million versus negative 226 million during the same period in the prior year.

此外，營運費用較上年有所下降，主要是由於與終止共同開發協議相關的一次性費用1,850 萬美元導致研發費用減少，整體研發費用降低，以及公司不斷努力優化我們的業務而導致的一般管理費用降低。

This is largely driven by the gross margin contribution in the period and lower OpEx particularly lower G&A costs on an adjusted basis.

這主要是由於該期間的毛利率貢獻以及較低的營運支出，特別是調整後的一般管理費用較低。

In Q3 2024 we reported adjusted EBITDA of 23 million versus negative 79 million during the third quarter of 2023.

2024 年第三季度，我們報告調整後 EBITDA 為 2,300 萬美元，而 2023 年第三季為負 7,900 萬美元。

Please see the table provided in the appendix for a reconciliation of our reported to adjusted results in terms of cash and liquidity. We closed the period ending September 30 with 118 million of cash on hand and a 28billion in borrowings.

請參閱附錄中提供的表格，以了解我們報告的現金和流動性方面的調整結果的調節。截至 9 月 30 日，我們手頭現金為 1.18 億美元，借款為 280 億美元。

With our recent refinancing behind us, our major product launch is underway and continued advancement of our pipeline. The company believes it has sufficient cash on hand to achieve free cash flow positive. We closed the period ending September 30th with 301.7 million shares outstanding including unvested earnout shares in the appendix to our management presentation. You will find a summary of shares outstanding.

隨著我們最近的再融資，我們的主要產品正在進行中，並持續推進我們的產品線。該公司相信其手頭上有足夠的現金來實現正的自由現金流。截至 9 月 30 日，我們已發行 3.017 億股流通股，其中包括管理階層介紹附錄中未歸屬的獲利股。您將找到已發行股票的摘要。

I will close today's presentation with a few brief comments regarding our financial guidance we are currently on track to lend within the ranges provided, our revenue guidance is 400million to 500 million and is driven by a combination of our new product launches and significant development and performance based milestones.

我將用一些關於我們的財務指導的簡短評論來結束今天的演講，我們目前正在按計劃在所提供的範圍內提供貸款，我們的收入指導為4 億至5 億美元，並由我們的新產品發布以及重大開發和業績共同推動。

Overall, we expect milestone revenue contributions to be slightly higher than we guided in 2024 driven by new licensing deals and earlier achievement of development progress been planned. We're excited to demonstrate the continued advancement of our pipeline which we believe will propel sustainable long term growth of the company as it relates to product revenues. As you heard from anil earlier, we have orders from our US partners of 1.3 million units for a AVT02 in 2024 and are increasing our shipments to deliver a substantial portion in the fourth quarter.

總體而言，由於新的授權交易和計劃提前實現開發進度，我們預計 2024 年里程碑式的收入貢獻將略高於我們的指導。我們很高興能夠展示我們管道的持續進步，我們相信這將推動公司的可持續長期成長，因為它與產品收入有關。正如您之前從 anil 那裡聽到的，我們從美國合作夥伴那裡收到了 2024 年 130 萬台 AVT02 的訂單，並且正在增加出貨量，以便在第四季度交付大部分。

We're making preparations to fulfill all shipments in the quarter. However, there remains a possibility that some quantities could phase into Q125 due to timing.

我們正在準備完成本季的所有出貨。然而，由於時間安排，部分數量仍有可能分階段進入 Q125。

Additionally, we are monitoring our mix of shipments to various geographies and customers which could have an impact on both revenues and product margins.

此外，我們正在監控向不同地區和客戶的出貨組合，這可能會對收入和產品利潤產生影響。

As we've previously mentioned, we are also working on the potential for pre launch revenues of AVT04 before year end contracting remains underway in the US. And timing and order size are still to be determined in preparation for our upcoming launch. We continue to build commercial inventory.

正如我們之前提到的，我們也在美國年底合約仍在進行之前研究 AVT04 上市前收入的潛力。時間和訂單規模仍有待確定，為我們即將推出的產品做好準備。我們繼續建立商業庫存。

Final outcome of these discussions should become clear in the coming weeks. This is all to say we are managing through a potential range of outcomes that can play out for us in the remaining final weeks of 2024.

這些討論的最終結果應該會在未來幾週內變得清晰。這就是說，我們正在應對一系列潛在的結果，這些結果可能會在 2024 年剩下的最後幾週內為我們帶來結果。

Finally, in October, the company exercised its option to pick interest in the first quarterly term of our new loan facility by deferring cash interest payments. We created greater flexibility during the time we are simultaneously increasing the capacity and scale of our manufacturing facility and building commercial inventory for new launches.

最後，在 10 月份，該公司行使其選擇權，透過延遲現金利息支付，在我們新貸款安排的第一季中收取利息。在我們同時提高製造設施的產能和規模並為新產品的推出建立商業庫存的同時，我們創造了更大的靈活性。

This is an attractive feature for us only available in the 1st year of our financing agreement as a result of this election, we are now forecasting cash interest payments in 2024 between $45million and $50 million.

對我們來說，這是一個有吸引力的功能，由於這次選舉，僅在我們的融資協議的第一年提供，我們現在預測2024 年的現金利息支付在4500 萬美元至5000 萬美元之間。

And with that, I'd like to turn the call back over to the operator for Q&A.

這樣，我想將電話轉回給接線生進行問答。

Thank you as a reminder to ask a question, you will need to press star 11 on your telephone keypad and wait for your name to be announced to withdraw your question. Please press star 11 again.

感謝您提醒提問，您需要按電話鍵盤上的星號 11 並等待您的名字被宣布才能撤回您的問題。請再按星號 11。

We will now take our first question, please stand by and the first question comes from the line of Thela Prasad from Barclays. Please go ahead. Your line is now open.

現在我們將提出第一個問題，請稍候，第一個問題來自巴克萊銀行的Thela Prasad。請繼續。您的線路現已開通。

Hi, good morning, everyone and congratulations on the quarter. So I have a few but I'll restrict it to. Firstly on the 48 threes, they were a bit of a surprise for me. Because as per my understanding when we visited the facility. I thought the facility was good for the next two years following the Jan 24 inspection and the next major inspection will be Jan 26 at least. So it looks like there's been an earlier inspection. Can you comment on that? And since you categorize this as a successful inspection, I would imagine the 48 threes were fairly benign. So, could you also elaborate on that? That's 12 would want to understand the guidance a bit more of, I understand the uncertainties by partnership. But considering that we are nine months done $39 million revenue is delivered till now. I'm surprised that the guidance wasn't tightened further. There's still $100 million spread with a $400million to $500 million guidance. If you could help me understand that too. Thanks.

大家早安，恭喜本季的業績。所以我有一些，但我會限制它。首先，48個三分球讓我有點驚訝。因為根據我參觀該設施時的了解。我認為在 1 月 24 日檢查之後，該設施在未來兩年內狀況良好，下一次主要檢查至少將在 1 月 26 日進行。看來之前有過檢查。你能對此發表評論嗎？既然你把這歸類為一次成功的檢查，我想這 48 個三分球是相當良性的。那麼，您能詳細說明一下嗎？那是 12 想要更多地了解指導，我了解合作夥伴關係的不確定性。但考慮到我們已經完成了 9 個月，到目前為止已經交付了 3900 萬美元的收入。我很驚訝指導方針沒有進一步收緊。與 4 億至 5 億美元的指導價相比，仍有 1 億美元的價差。如果你也能幫助我理解這一點。謝謝。

Yeah. Thank you for the question, Robert Wessman here. So basically FDA will most likely come with the cadence of every 2nd year to inspect the facility.

是的。謝謝你的提問，羅伯特‧韋斯曼。因此，基本上 FDA 很可能會以每兩年一次的節奏對設施進行檢查。

We of course, went through a, a preapproval inspection on two products which are a AVT02 and AVT04.

當然，我們對 AVT02 和 AVT04 兩種產品進行了預核准檢查。

But we always knew that they would come again for a regular commercial GMP inspection if you will. So as we saw it, the FDA was combining few inspections out of Scandinavia and the most likely came to Iceland to combine that the outcome of the second inspection actually came with a very short notice. Was a very successful one we believe. And I would say those two observation we got are easily addressable. But of course, by saying that, I mean, we take every inspection and the observation seriously if you will, I mean, if you look at the overall the two observation one was pointing at the past action. I believe back to 222 with how we, we are handling the reporting, on our auto injector. And we just committed to change that reporting going forward that was related to a different market than even yours. And the other one was related to an assay, which is a commonly used and we are using with the same outcome and success as everyone else. But the overall FDA is starting to divert the industry as whole away from that method. And we already had the starting to use a different method which for us market, we have already submitted a variation because we need a variation to include the a different type of method. But overall, it was in my mind, a, a great success and just underlined on a very short notice, the company was very much ready for FDA and we will continue to be inspection ready at any given time. And the, just to highlight that also, we are submitting three products into us and it's highly likely that we will have a inspection again prior approval inspection if you will already next year because of the three submission. But the cadence of general TMP inspection is every two year and this is what that was the second one I thought.

但我們一直知道，如果您願意，他們會再次來進行定期商業 GMP 檢查。因此，正如我們所看到的，FDA 正在結合斯堪的納維亞半島的少數檢查，而最有可能來到冰島的檢查結合起來，第二次檢查的結果實際上是在很短的時間內發出的。我們相信這是一個非常成功的。我想說，我們得到的這兩個觀察很容易解決。但是，當然，我的意思是，如果你願意的話，我們會認真對待每一次檢查和觀察，我的意思是，如果你看一下整體，兩個觀察結果都指向過去的行動。我相信回到222我們如何處理關於我們的自動注射器的報告。我們只是致力於改變未來的報告，該報告與甚至與您的市場不同的市場相關。另一個與測定有關，這是一種常用的方法，我們使用它獲得了與其他人相同的結果和成功。但 FDA 正在開始讓整個產業遠離這種方法。我們已經開始使用不同的方法，對於我們的市場，我們已經提交了一個變體，因為我們需要一個變體來包含不同類型的方法。但總的來說，在我看來，這是一次巨大的成功，並且在很短的時間內強調了公司​​已經為 FDA 做好了充分準備，我們將繼續在任何給定時間做好檢查準備。而且，還要強調一點，我們正在向我們提交三種產品，如果您明年因為這三種提交而已經進行了批准檢查，那麼我們很可能會再次進行事先批准檢查。但一般 TMP 檢查的節奏是每兩年一次，這是我想到的第二次。

Hi, This is Joel. Thanks for your question. I think with respect to guidance as 2024 progresses, we are seeing quite a rapid ramp in our revenues and you can see that in 2nd and 3rd quarter results. And as we mentioned, we expect to see that continue to increase in the fourth quarter. But there still remains as you highlight a wide variety of outcomes that could impact the product mix and profitability. And this includes, you know, some expected shipments that may move into very early in 25 which would have no negative commercial bearing, but it does somewhat restrict our ability to refine our guidance any further for the calendar year.

嗨，這是喬爾。謝謝你的提問。我認為，隨著 2024 年的進展，我們的收入將快速成長，您可以在第二季和第三季的業績中看到這一點。正如我們所提到的，我們預計第四季這一數字將繼續增加。但當您強調可能影響產品組合和盈利能力的各種結果時，仍然存在問題。你知道，這包括一些可能會在 25 年初進行的預期發貨，這不會產生負面商業影響，但它確實在一定程度上限制了我們進一步完善日曆年指導的能力。

Thanks Joe. If I could just maybe pursue that a bit more, considering that you have product revenues of around $62 million in Q3 and that is huge portion of Humira is going to be posted in Q4. I would have thought that just product revenues from Humira alone would take you through the beyond the $400 million mark.

謝謝喬。如果我可以再追求一點，考慮到第三季的產品收入約為 6,200 萬美元，而修美樂的很大一部分將在第四季度發布。我以為光是 Humira 的產品收入就能突破 4 億美元大關。

Yeah, I mean, in the fourth quarter we are, as we mentioned, planning to continue shipments in the fourth quarter, it is a high volume of shipments. And again, it's a question of how much of that could potentially cross over into 25. That's both for the launch of or I should say products related to Humira but also new product launches as well.

是的，我的意思是，正如我們所提到的，我們計劃在第四季度繼續發貨，發貨量很大。再說一次，問題是其中有多少可能會跨越到 25 個。這既是為了發布，或者我應該說是與 Humira 相關的產品，也是為了新產品的發布。

But. Yeah, it's kind of inconvenient that the December month is the end of the calendar year if you will. So, it's a matter of how much we ship in December versus January and the business is there. And the just to underline that what the question is related to, as we have said, our fourth quarter will be by far the strongest shipment of products in the entire year to those 24 and we are getting well to it. We are seeing that is shaping up very nicely. But again, there might be some spill over to us 25 which we don't want to really commit to 100%. Now, whether it ends all in December or whether it spills over to next year.

但。是的，如果你願意的話，十二月是日曆年的結束，這有點不方便。因此，問題在於我們 12 月與 1 月的出貨量以及業務量。只是為了強調這個問題所涉及的問題，正如我們所說，我們的第四季度將是迄今為止全年對這 24 個國家的產品出貨量最強勁的季度，我們正在順利實現這一目標。我們看到情況進展非常順利。但同樣，我們 25 人可能會受到一些影響，但我們並不想真正做到 100%。現在，無論是在 12 月結束還是延續到明年。

Thank you. We will now take our next question, please stand by and the next question comes from the line of Niall Alexander from Deutsche Bank. Please go ahead. Your line is now open.

謝謝。我們現在開始下一個問題，請稍候，下一個問題來自德意志銀行的 Niall Alexander。請繼續。您的線路現已開通。

Hi, it's Niall Alexander from Deutsche Bank. Thanks for taking my questions. So just to please for now, the FDA inspection, I guess just to push a little bit more on that, will that have or could it have any impact on the launch of Stelara by similar at the beginning of next year and on top of the guidance as well? Sorry. So you've, it was early on in the year, you've communicated our 600million to 800 million and revenue guidance with the news of the change in supply shipment. The news on the FDA inspection is there, should we assume that that guidance is, is reasonable to, to have for the time being and sorry if I can just squeeze in one more on the idea, biosim, I guess in your view, what do you think Alvotech or sorry in your view, what do you think Amgen is doing right to get over the line? And what do you think alvotech needs to do to get them, get their idea bis similar in the US potentially over the line? Thank you.

大家好，我是德意志銀行的尼爾亞歷山大。感謝您回答我的問題。因此，暫時請大家注意一下，FDA 的檢查，我想只是為了進一步推動這一點，這是否會對明年年初類似的 Stelara 上市產生任何影響？對不起。所以，今年早些時候，您就透過供應出貨量變化的消息傳達了我們的 6 億至 8 億美元和收入指引。關於 FDA 檢查的消息就在那裡，我們是否應該假設該指導是合理的，暫時有，抱歉，如果我可以再補充一下這個想法，biosim，我想在你看來，什麼您認為Alvotech 還是抱歉，您認為安進（Amgen）在哪些方面做得對，從而越過了界限？您認為 Alvotech 需要做什麼才能吸引他們，讓他們的想法在美國有可能成功？謝謝。

Yes, Robert here. Thanks for the question. So if you look at our first successful after the inspection at the beginning of the year, it was a pre approval inspection for two products and we went through that in a stellar way with 1,483. When you have a general GMP inspection is a little bit different inspection, but usually brought on the whole systems and being first time commercial and first time commercial inspection, if you will, it reaches out in a little bit different areas clearly and surely this is not going to hold off any, any loes having 243. The first one had 143 this one had 243.

是的，羅伯特在這裡。謝謝你的提問。因此，如果你看看我們在年初檢查後的第一次成功，這是對兩種產品的預先批准檢查，我們以出色的方式完成了 1,483 項產品的檢查。當您進行一般GMP 檢查時，檢查會略有不同，但通常會對整個系統進行檢查，並且是首次商業檢查和首次商業檢查，如果您願意的話，它會明確地涉及到一些不同的領域，這肯定是不會阻止任何擁有 243 的洛伊。第一個有 143 個，這個有 243 個。

The 243 are easily addressable as I mentioned, surely will not hold the of any launches and having those 243 I believe is a great success. To be Honest, being easily addressable on, on the, on the guidance. We have not given out the guidance, new guidance for 225 we will do that once the commercial negotiation has completed for a AVT04.

正如我所提到的，243 很容易尋址，肯定不會容納任何發射，我相信擁有這些 243 是一個巨大的成功。說實話，在指導上很容易解決。我們還沒有給予針對 225 的指導，一旦 AVT04 的商業談判完成，我們就會給予新的指導。

So I meanwhile, we have not given out the new guidance. I think it's very fair to assume that the old guidance is still basically valid 600million to 800 million as you mentioned. So, we should generally assume that is still in place until we come in with something else.

所以同時，我們還沒有給出新的指導意見。我認為，正如您所提到的，假設舊的指導方針仍然基本上有效（6 億至 8 億）是非常公平的。因此，我們通常應該假設它仍然存在，直到我們提出其他東西為止。

And, we can talk about the opportunity which we saw in ancient, but just one sentence on that for me is that we think this could create the amazing opportunity for us. We are of course evaluating the opportunity. We know how our product is differently developed from the one which are injected. So, it was exciting news when I came out, but Anne, you went out to that. Sure.

而且，我們可以談論我們在古代看到的機會，但對我來說，只有一句話是，我們認為這可以為我們創造驚人的機會。我們當然正在評估這個機會。我們知道我們的產品與注射產品的開發方式有何不同。所以，當我出櫃時，這是令人興奮的消息，但是安妮，你也出去了。當然。

Thank you, Robert. So, first of all, I would like to you that we will be launching in Europe in day one, which will be still next year in 2025.

謝謝你，羅伯特。首先，我想告訴大家，我們將在第一天在歐洲推出，也就是明年 2025 年。

And then when it comes to the US, as you can appreciate at this time, I won't comment further on our IP strategy for us. The first step will be gaining filing acceptance which should happen soon. And from there, I would assume there will be more public information that becomes available. But as Robert mentioned, we are very excited of this opportunity. It's an interesting opportunity here and the we have a clear strategy to hopefully be in the market as soon as possible.

然後說到美國，正如您現在可以理解的那樣，我不會進一步評論我們的智慧財產權策略。第一步將是獲得申請接受，這應該很快就會發生。從那時起，我認為將會有更多的公開資訊可用。但正如羅伯特所提到的，我們對這個機會感到非常興奮。這是一個有趣的機會，我們有一個明確的策略，希望盡快進入市場。

Thank you. We will now take our next question, please stand by and the next question comes from the line of [Carl Bnds from Northland capital markets]. Please go ahead. Your line is now open.

謝謝。我們現在開始下一個問題，請稍候，下一個問題來自[來自北國資本市場的 Carl Bnds]。請繼續。您的線路現已開通。

Thanks for taking question and congratulations on your progress. I'm wondering if you can comment at all in terms of your expectation of where gross profit margin might be over the next 12 to 18 months considering product, you know, product sales ramp and efficiencies that you've achieved. Thanks.

感謝您提出問題並祝賀您的進步。我想知道您是否可以根據您對未來 12 到 18 個月內毛利率的預期發表評論，考慮到產品、您知道的產品銷售成長和您所實現的效率。謝謝。

Hi, thanks for your question. You saw in my opening remarks, our product margins in particular went from 17% to 37% in the third quarter. We do expect our product margins to continue to expand as we exit the year at this point in time. We're not providing any guidance for 2025.

你好，謝謝你的提問。你在我的開場白中看到，第三季我們的產品利潤率從 17% 上升到 37%。我們確實預計，隨著今年的結束，我們的產品利潤率將繼續擴大。我們不會提供 2025 年的任何指導。

Great, fair enough and then just as a quick follow up, can you provide any breakout on us product sales for the third quarter in nine months? Thanks.

很好，很公平，然後作為快速跟進，您能否提供九個月內第三季度美國產品銷售的任何突破？謝謝。

We currently do not provide any breakout of our US product sales by product. But you know what we can say is that our ex US contribution is significant and can reach, you know, up to a third, we're expecting of our total revenues by the end of the year.

目前，我們沒有按產品提供美國產品銷售的任何細分數據。但我們可以說的是，我們在美國以外的貢獻是巨大的，並且可以達到我們預計到年底總收入的三分之一。

Yeah, Carl, I think as we mature and diversify, you're going to see more granular reporting, but obviously, you know, these are early launches and you know, there's one product currently launched in the US.

是的，卡爾，我認為隨著我們的成熟和多元化，您將看到更精細的報告，但顯然，您知道，這些都是早期發布，而且您知道，目前有一種產品在美國推出。

Exactly. No worries. Thank you.

確切地。不用擔心。謝謝。

Thank you.

謝謝。

As there are no further questions, I would like to hand back to Benedikt Stefansson for any closing remarks.

由於沒有其他問題了，我想請 Benedikt Stefansson 發表結束語。

Okay. On behalf of the Alvotech feed team, I would like to thank you all for participating in today's call. We look forward to talking to you all again and I wish you a very good end of the day. Thank you. Bye.

好的。我謹代表 Alvotech Feed 團隊感謝大家參加今天的電話會議。我們期待再次與大家交談，並祝您今天愉快。謝謝。再見。

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。